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NCT03045887
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2292767 in Healthy Participants Who Smoke Cigarettes\n\n**Trial Summary:** \n\n\n This study is the first administration of GSK2292767 to humans. The study will evaluate the\r\n safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat\r\n inhaled doses of GSK2292767 in healthy smokers. This study is intended to provide sufficient\r\n confidence in the safety of the molecule and preliminary information on target engagement to\r\n allow progression to further repeat dose and proof of mechanism studies. This is a two part,\r\n single site, randomized, double-blind (sponsor open), placebo controlled study. Part A will\r\n consist of two 3-period interlocking cohorts to evaluate the safety, tolerability and\r\n pharmacokinetics of ascending single doses of GSK2292767 administered as a dry powder\r\n inhalation. Part B is planned to follow Part A and progression will be based on an acceptable\r\n safety, tolerability and pharmacokinetic profiles. Subjects will receive repeat doses of\r\n GSK2292767 once daily for 14 days during Part B.\r\n \n\n**Trial Keywords:** ['repeat dose', 'GSK2292767', 'smoke', 'tolerability', 'safety', 'dry powder inhalation', 'pharmacokinetics', 'single dose']\n\n**Phase:** Phase 1\n\n**Condition:** Asthma\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 50 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Participant must be 18 to 50 years of age inclusive, at the time of signing the\r\n informed consent\r\n\r\n - Participants who are overtly healthy as determined by medical evaluation including\r\n (medical history, physical examination, laboratory tests, and cardiac monitoring). A\r\n participant with a clinical abnormality or laboratory parameters outside the reference\r\n range expected for them and the population being studied may be included only if the\r\n Investigator believes that the finding is unlikely to introduce additional risk\r\n factors and will not interfere with the study procedures or outcomes\r\n\r\n - Participants who are current daily cigarette smokers (manufactured and self-rolled).\r\n Must have smoked regularly in the 12-month period preceding the screening visit\r\n\r\n - Normal spirometry (FEV1 >=80% of predicted) at screening\r\n\r\n - Body weight >=50 kilograms (kg) and body mass index (BMI) within the range 18 to 31\r\n kg/square meter (m^2) (inclusive)\r\n\r\n - Male and female\r\n\r\n - Male participants: A male participant must agree to use contraception as detailed\r\n in the protocol during the treatment period and for at least from the time of\r\n first dose of study medication until at least 55 (5x11) hours plus an additional\r\n 90 days after the last dose of study medication and refrain from donating sperm\r\n during this period. GSK2292767 has a predicted half-life of approximately 11\r\n hours\r\n\r\n - Female participants: A female participant is eligible to participate if she is\r\n not pregnant, not breastfeeding, and not a woman of childbearing potential\r\n (WOCBP)\r\n\r\n - Capable of giving signed informed consent which includes compliance with the\r\n requirements and restrictions listed in the informed consent form (ICF) and in the\r\n protocol\r\n\r\n Exclusion Criteria:\r\n\r\n - History or presence of current cardiovascular, respiratory, hepatic, renal,\r\n gastrointestinal, endocrine, haematological, or neurological disorders capable of\r\n significantly altering the absorption, metabolism, or elimination of drugs;\r\n constituting a risk when taking the study treatment; or interfering with the\r\n interpretation of data\r\n\r\n - Abnormal blood pressure as determined by the investigator\r\n\r\n - Alanine transaminase (ALT) >1.5xupper limit of normal (ULN)\r\n\r\n - Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is\r\n fractionated and direct bilirubin <35%)\r\n\r\n - Current or chronic history of liver disease, or known hepatic or biliary abnormalities\r\n (with the exception of Gilbert's syndrome or asymptomatic gallstones)\r\n\r\n - Average corrected QT interval by Fridericia's formula (QTcF) >450 milliseconds (msec)\r\n (based on triplicate ECGs)\r\n\r\n - Participants who have asthma or a history of asthma (except in childhood and which has\r\n now remitted)\r\n\r\n - Past or intended use of over-the-counter or prescription medication including herbal\r\n medications within 14 days prior to dosing. Specific concomitant medications listed in\r\n protocol may be allowed\r\n\r\n - Live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines\r\n during the study\r\n\r\n - Participation in the study would result in loss of blood or blood products in excess\r\n of 500 milliliters (mL) within 56 days\r\n\r\n - Exposure to more than 4 new chemical entities within 12 months prior to the first\r\n dosing day\r\n\r\n - Current enrolment or past participation within the last 90 days of exposure to any\r\n other clinical study involving an investigational study treatment or any other type of\r\n medical research\r\n\r\n - Presence of Hepatitis B surface antigen (HBsAg) at screening Positive Hepatitis C\r\n antibody test result at screening\r\n\r\n - Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3\r\n months prior to first dose of study treatment\r\n\r\n - Positive pre-study drug/alcohol screen\r\n\r\n - Positive human immunodeficiency virus (HIV) antibody test\r\n\r\n - Regular use of known drugs of abuse\r\n\r\n - Regular alcohol consumption within 3 months prior to the study defined as: An average\r\n weekly intake of >14 units for males and females. One unit is equivalent to 8 grams\r\n (g) of alcohol: a half-pint (approximately 240 mL of beer, 1 glass (125 mL) of wine or\r\n 1 (25 mL) measure of spirits\r\n\r\n - Sensitivity to any of the study treatments, or components thereof, or drug or other\r\n allergy that, in the opinion of the investigator or medical monitor, contraindicates\r\n participation in the study\r\n\r\n - Participants who are unable to produce a total weight of at least 100 milligrams (mg)\r\n of selected sputum during sputum induction at screening\r\n\r\n - Participants whose primary consumption of tobacco is via methods other than cigarettes\r\n (manufactured or self-rolled). Primary methods of tobacco consumption that are\r\n excluded include, but are not limited to pipes and cigars\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['GSK2292767 50 μg', 'GSK2292767 500 μg', 'Placebo']\n- **Description:** ['GSK2292767 50 μg blended with lactose and magnesium stearate per blister as powder for inhalation', 'GSK2292767 500 μg blended with lactose and magnesium stearate per blister as powder for inhalation', 'Lactose as powder for inhalation']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04406194
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nBioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions\n\n**Trial Summary:** \n\n\n A single dose of Reference product containing 200 mg favipiravir and a single dose of Test\r\n product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at\r\n room temperature, in each period under fasting conditions with current pandemic precautions.\r\n \n\n**Trial Keywords:** ['COVID-19 drug treatment', 'Antiviral Agents', 'Favipiravir', 'Novagenix', 'Farmagen']\n\n**Phase:** Phase 1\n\n**Condition:** Bioequivalence\n\n**Condition Keywords:** None\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 20 Years\n- **Maximum Age:** 40 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Healthy Caucasian male subjects aged between 20 and 40 years\r\n\r\n 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink\r\n coffee during the study period\r\n\r\n 3. Two Negative Covid-19 PCR test results\r\n\r\n 4. Negative alcohol breath test results\r\n\r\n 5. Normal physical examination at screening visit\r\n\r\n 6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in\r\n the desirable range according to the age\r\n\r\n 7. Ability to communicate adequately with the investigator himself or his representatives\r\n\r\n 8. Ability and agreement to comply with the study requirements\r\n\r\n 9. Normal blood pressure and heart rate measured under stabilised conditions at the\r\n screening visit after at least 5 minutes of rest under supine position: SBP within 100\r\n to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm\r\n\r\n 10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of\r\n rest\r\n\r\n 11. Laboratory results within normal range or clinically non-significant (CBC, glucose,\r\n urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium,\r\n calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein\r\n and urinalysis), drug addiction scanning in urine results in negative (amphetamine,\r\n barbiturate, benzodiazepine, cannabinoid, cocaine, opiate)\r\n\r\n 12. Understanding of the study and agreement to give a written informed consent according\r\n to section 20.3\r\n\r\n 13. Understanding of that he and his partner will use a practice adequate contraception\r\n during the study and at least 7 days after the study\r\n\r\n 14. Volunteer's compliance with isolation rules defined at study protocol\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Who have atopic constitution or asthma or known allergy for favipiravir and/or any\r\n other ingredients of the products.\r\n\r\n 2. Any history or presence of clinical relevance of cardiovascular, neurological,\r\n musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary,\r\n endocrinological, metabolism or psychiatric disease, any type of porphyria.\r\n\r\n 3. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first\r\n drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10\r\n mmHg occurs between sitting/supine to standing position subject will be excluded (if\r\n it deemed necessary by the investigator),\r\n\r\n 4. Presence or history of malabsorption or any gastrointestinal surgery except\r\n appendectomy or except herniotomy.\r\n\r\n 5. Subjects who have given more than 400 mL blood within the last two months before the\r\n first drug administration and subjects who have participated to any drug research\r\n within the last two months before the first drug administration.\r\n\r\n 6. Subjects suspected to have a high probability of non-compliance to the study procedure\r\n and/or completion of the study according to the investigator's judgement.\r\n\r\n 7. Subjects who used any of prescribed systemic or topical medication (including OTC\r\n medication) within 2 weeks (or six elimination half lives of this medication,\r\n whichever is longer) before the initiation of the study (except single doses of\r\n analgesics which have no drug interaction with study product).\r\n\r\n 8. Use of any vitamins or herbal products within 7 days prior to the initial dose of the\r\n study medication.\r\n\r\n 9. History of allergic response to heparin.\r\n\r\n 10. Subjects who have any chronic disease which might interfere with absorption,\r\n distribution, metabolism or excretion of the drug.\r\n\r\n 11. Subjects who regular consumed of beverages or food containing methylxanthines (e.g.\r\n coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg\r\n methylxanthines per day.\r\n\r\n 12. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug\r\n administration, during the study.\r\n\r\n 13. History of drug abuse.\r\n\r\n 14. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or\r\n 10 units per week and/or positive alcohol breath test results (Note: one unit of\r\n alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits).\r\n\r\n 15. Positive blood test for HBV, HCV and HIV.\r\n\r\n 16. Who have relationship to the investigator.\r\n\r\n 17. Who are not suitable to any of inclusion criteria.\r\n\r\n 18. History of difficulty of swallowing.\r\n\r\n 19. Intake of depot injectable solutions (including study medications) within 6 months\r\n before start of the study.\r\n\r\n 20. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before\r\n start of the study.\r\n\r\n 21. Special diet due to any reason, e.g. vegetarian.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['FAVICOVIR 200 mg Film Tablet', 'AVIGAN 200 mg Film Tablets']\n- **Description:** ['FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.', 'AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.']\n- **Mesh Terms:** Favipiravir\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT05064332
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)\n\n**Trial Summary:** \n\n\n This is a Phase 1, open label, fixed sequence study of the effect of multiple dose\r\n PF-06650833 on single dose OC PK in healthy female subjects.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Female\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 60 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n Subjects must meet all of the following inclusion criteria to be eligible for enrollment in\r\n the study:\r\n\r\n 1. Healthy female subjects\r\n\r\n 2. Female subjects of non childbearing potential must meet at least 1 of the following\r\n criteria:\r\n\r\n 1. Achieved postmenopausal status, defined as follows: cessation of regular menses\r\n for at least 12 consecutive months with no alternative pathological or\r\n physiological cause; and have a serum follicle stimulating hormone (FSH) level\r\n confirming the postmenopausal state;\r\n\r\n 2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\r\n\r\n 3. Have medically confirmed ovarian failure.\r\n\r\n All other female subjects (including female subjects with tubal ligations) are\r\n considered to be of childbearing potential and will be eligible with adequate\r\n contraceptive usage.\r\n\r\n 3. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).\r\n\r\n Exclusion Criteria:\r\n\r\n Subjects with any of the following characteristics/conditions will not be included in the\r\n study:\r\n\r\n 1. Evidence or history of clinically significant hematological, renal, endocrine,\r\n pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or\r\n allergic disease (including drug allergies, but excluding untreated, asymptomatic,\r\n seasonal allergies at the time of dosing).\r\n\r\n 2. History of alcohol abuse or binge drinking and/or any other illicit drug use or\r\n dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5\r\n (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,\r\n alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1\r\n ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).\r\n\r\n 3. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).\r\n\r\n 4. Any current evidence of untreated active or latent or inadequately treated infection\r\n with Mycobacterium tuberculosis (TB).\r\n\r\n 5. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive\r\n testing\r\n\r\n 6. Benign ethnic (cyclic) neutropenia.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['PF-06650833', 'Ethinyl estradiol (EE) and levonogestrel (LN)']\n- **Description:** ['400 mg by mouth (PO) Once daily (QD) for 11 days', 'Single dose of Oral tablet containing 30 ug EE and 150 ug of LN']\n- **Mesh Terms:** ['Ethinyl Estradiol', 'Contraceptive Agents', 'Contraceptives, Oral', 'Estradiol']\nSMILES: ['CC[C@H]1[C@@H](COC2=C3C=C(OC)C(=CC3=CC=N2)C(N)=O)NC(=O)[C@H]1F', '[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT01348763
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nThe Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study\n\n**Trial Summary:** \n\n\n This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects\r\n currently attending for HIV care at St. Mary's Hospital, London will be eligible.\r\n \n\n**Trial Keywords:** HIV\n\n**Phase:** Phase 1\n\n**Condition:** HIV\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['B20', 'Z71.7', 'Z29.81', 'O98.72', 'Z21', 'O98.73', 'R75']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - HIV-1 infected males or females\r\n\r\n - signed informed consent\r\n\r\n - plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the\r\n last 3 months\r\n\r\n - currently receiving an antiretroviral regimen comprising of: tenofovir 245 mg\r\n daily,emtricitabine 200 mg daily, darunavir 800 mg daily and ritonavir 100 mg daily\r\n\r\n - no previous protease inhibitor resistance documented on HIV-1 genotypic resistance\r\n testing if an HIV resistance test available\r\n\r\n - Between 18 to 65 years of age, inclusive\r\n\r\n - subjects in good health upon medical history, physical exam, and laboratory testing\r\n\r\n - BMI above or equal to 18 and below 32\r\n\r\n - Female subjects who are heterosexually active and of childbearing potential (i.e., not\r\n surgically sterile or at least two years post menopausal) must practice contraception\r\n as follows from screening until 8 weeks after completion of the study:\r\n\r\n - barrier contraceptives (condom OR diaphragm PLUS spermicide) or oral, implant or\r\n injectable hormonal contraceptive PLUS a barrier contraceptive or\r\n\r\n - IUD /IUS PLUS a barrier contraceptive\r\n\r\n - Female subjects of childbearing potential must have a negative urine pregnancy test.\r\n\r\n - Male subjects who are heterosexually active must use two forms of barrier\r\n contraception (e.g., condom with spermicide) during heterosexual intercourse, from\r\n screening through completion of the study.\r\n\r\n - Have no serologic evidence of active HBV infection evidenced by negative hepatitis B\r\n surface antigen and no serologic evidence of hepatitis C virus infection evidenced by\r\n a negative HCV antibody at screening.\r\n\r\n - Have screening laboratory results (haematology and chemistry that fall within the\r\n normal range of the central laboratory's reference ranges unless the results have been\r\n determined by the Investigator to have no clinical significance\r\n\r\n - CCR5 tropic HIV virus based on a genotypic tropism assay from either a stored plasma\r\n sample where available or fresh plasma\r\n\r\n Exclusion Criteria:\r\n\r\n - current alcohol abuse or drug dependence\r\n\r\n - positive urine drug of abuse screening\r\n\r\n - pregnancy\r\n\r\n - active opportunistic infection or significant co-morbidities\r\n\r\n - current disallowed concomitant medication\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Maraviroc', 'Truvada', 'Darunavir']\n- **Description:** ['Maraviroc 150 mg daily', 'daily until 10. day then stop', 'daily until 10. day then stop']\n- **Mesh Terms:** ['Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination', 'Maraviroc', 'Darunavir']\nSMILES: ['CC(C)C1=NN=C(C)N1[C@H]1C[C@@H]2CC[C@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)C1=CC=CC=C1', '[H][C@@]12CCO[C@]1([H])OC[C@@H]2OC(=O)N[C@@H](CC1=CC=CC=C1)[C@H](O)CN(CC(C)C)S(=O)(=O)C1=CC=C(N)C=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02014116
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body\n\n**Trial Summary:** \n\n\n The main purpose of this study is to see how safe the investigational drug known as LY3009120\r\n is and whether it will work to help people with advanced cancer or cancer that has spread to\r\n other parts of the body.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Neoplasms', 'Neoplasm Metastasis', 'Melanoma', 'Carcinoma, Non-Small-Cell Lung', 'Colorectal Neoplasms']\n\n**Condition Keywords:** ['Neoplasms', 'Neoplasm Metastasis', 'Colorectal Neoplasms', 'Carcinoma, Non-Small-Cell Lung']\n\n**ICD Code:** [\"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\", \"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\", \"['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']\", \"['D02.20', 'D02.21', 'D02.22']\", \"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Advanced or metastatic cancer\r\n\r\n - Other available therapies have failed to cure the cancer\r\n\r\n - The cancer that has no proven effective therapy\r\n\r\n - The cancer can be biopsied (depending on the tumor type and/or the dose of drug\r\n received, tumor biopsies may be required)\r\n\r\n - Able to swallow capsules\r\n\r\n Exclusion Criteria:\r\n\r\n - Have active cancer in the brain or spinal cord\r\n\r\n - Have an active infection of any kind (fungal, viral, or bacterial)\r\n\r\n - Have a cancer of the blood\r\n\r\n - Are pregnant or breastfeeding\r\n\r\n - Have some types of eye problems or impairments\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** LY3009120 capsule\n- **Description:** Administered orally.\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03383614
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety, Tolerability and PK of Multiple-ascending Doses of Emodepside\n\n**Trial Summary:** \n\n\n The study evaluates safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of\r\n emodepside, after administration as a Liquid Service Formulation (LSF), over 10 days, in\r\n healthy male caucasian subjects.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Filariasis\n\n**Condition Keywords:** Filariasis\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 45 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Male, Caucasian volunteers, deemed healthy based on a clinical history, physical\r\n examination, ECG, vital signs, and laboratory tests of blood and urine.\r\n\r\n 2. 18 to 45 years of age.\r\n\r\n 3. Normal body weight (BMI; Quetelet index) in the range 18 to 30.1 kg/m2 at screening.\r\n\r\n 4. Blood pressure and heart rate in the supine position prior to randomisation must be\r\n within the ranges 90-140 mm Hg systolic, 60-90 mm Hg diastolic; heart rate 45-100\r\n beats/min.\r\n\r\n 5. Sufficient intelligence to understand the nature of the trial and any hazards of\r\n participating in it. Ability to communicate satisfactorily with the Investigator and\r\n to participate in, and comply with the requirements of, the entire trial.\r\n\r\n 6. Willingness to give written consent to participate, after reading the information and\r\n consent form, and after having the opportunity to discuss the trial with the\r\n Investigator or his delegate.\r\n\r\n 7. Willingness to give written consent to have data entered into the Overvolunteering\r\n Prevention System.\r\n\r\n 8. Willingness to agree to the contraceptive requirements of the study from the first\r\n dose until 120 days after the last dose of study medication.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Administration of a licensed or unlicensed medicinal product as part of another\r\n clinical trial within the 3 months before, or within 5 half-lives of, their first dose\r\n of study medication, whichever is longer, or is currently in the follow-up period for\r\n any clinical trial.\r\n\r\n 2. Clinically relevant abnormal medical history, concurrent medical condition, acute or\r\n chronic illness or history of chronic illness (such as diabetes mellitus or other\r\n abnormalities of glucose homeostasis) sufficient to invalidate the subject's\r\n participation in the trial or make it unnecessarily hazardous.\r\n\r\n 3. Past surgery (e.g., stomach bypass) or medical condition that might affect absorption\r\n of study drug taken orally.\r\n\r\n 4. Presence of abnormal physical findings, ECG, or laboratory values at the pre-trial\r\n screening assessment that could interfere with the objectives of the trial or the\r\n safety of the subject.\r\n\r\n 5. Loss of more than 400 mL of blood within 3 months before admission.\r\n\r\n 6. Clinically relevant history of vital organ disease or other disease of an organ or the\r\n central nervous system.\r\n\r\n 7. Current or previous medical or psychiatric disorder, condition or history of such\r\n (e.g., seizures) that, in the opinion of the Investigator or the Sponsor, would\r\n increase the risk associated with study participation, or impair the subject's ability\r\n to participate or complete this study.\r\n\r\n 8. Positive test for hepatitis B, hepatitis C or HIV.\r\n\r\n 9. Febrile illness within 1 week before the first dose of study medication.\r\n\r\n 10. History of severe allergy, non-allergic drug reactions, severe adverse reaction to any\r\n drug, or multiple drug allergies.\r\n\r\n 11. Subjects with hypersensitivity to any ingredient of the study medication, including\r\n the active ingredient, emodepside.\r\n\r\n 12. Presence or history of drug or alcohol abuse in the last 10 years, or intake of more\r\n than 21 units of alcohol weekly.\r\n\r\n 13. Regular daily consumption of more than one liter of xanthine-containing beverages.\r\n\r\n 14. Regular daily consumption of more than 5 cigarettes daily, or use more than 3 grams\r\n (1/8 ounce) of tobacco.\r\n\r\n 15. Use of a prescription medicine during the 28 days before the first dose of study\r\n medication or use of an over-the-counter medicine (with exception of acetaminophen\r\n [paracetamol]), during the 7 days before the first dose of study medication.\r\n\r\n 16. Use of dietary supplements or herbal remedies (such as St John's Wort) that are known\r\n to be inducers or inhibitors of CYP3A4, or other co-medications known to be relevant\r\n substrates of CYP3A4, during the 28 days before the first dose of study medication\r\n (see list in the Study Procedures Manual).\r\n\r\n 17. Use of dietary supplements or herbal remedies (such as St John's Wort) that are known\r\n to be strong inhibitors of P-gp, or other co-medications known to be relevant\r\n substrates of P-gp, during the 28 days before the first dose of study medication (see\r\n list in the Study Procedures Manual).\r\n\r\n 18. Relevant pathological abnormalities in the ECG at screening, such as a second or\r\n third-degree atrioventricular (AV) block or prolongation of the QRS complex over 120\r\n msec or QTc-interval over 450 msec (corrected using Bazett's [QTcB] or Fridericia's\r\n [QTcF] formulae).\r\n\r\n 19. Evidence of drug abuse (via urine testing) at the screening assessment or admission to\r\n the ward.\r\n\r\n 20. Use of excluded therapies that may impact on the interpretation of study results in\r\n the opinion of the Investigator or Sponsor.\r\n\r\n 21. Objection by General Practitioner (GP) to subject entering trial.\r\n\r\n 22. History of residing for 6 or more continuous months, within the last 3 years, in\r\n regions with endemic parasitic infections as determined by the Investigator.\r\n\r\n 23. Possibility that subject will not cooperate with the requirements of the protocol.\r\n\r\n 24. No contact lenses wear within 1 month before dosing. Wearing contact lenses is not\r\n permitted during the study.\r\n\r\n 25. Any ocular disorder for which topical ocular therapy is currently or chronically\r\n prescribed, including inflammatory eye disease (dry eye allergic conjunctivitis\r\n [seasonal allergic conjunctivitis, vernal keratoconjunctivitis, atopic\r\n keratoconjunctivitis], uveitis and glaucoma).\r\n\r\n 26. Past history of ocular disease requiring ongoing treatment.\r\n\r\n 27. Past ocular surgery including laser or other refractive corneal surgery.\r\n\r\n 28. Evidence of eye irritation, visual difficulties, corneal opacity, ocular surface\r\n (corneal or conjunctival damage, with or without ocular symptoms).\r\n\r\n 29. Evidence of narrow anterior chamber angles causing increased risk of acute glaucoma.\r\n\r\n 30. Evidence of ocular media opacity including lens opacity/vitreous opacities.\r\n\r\n 31. Evidence of retinal or optic nerve pathology.\r\n\r\n 32. Evidence of pronounced colour blindness, as indicated by an Ishihara score of 9/13 or\r\n below.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** LSF emodepside (BAY 44-4400) or matching placebo\n- **Description:** Emodepside administered as an LSF oral solution (1mg/mL)\n- **Mesh Terms:** Emodepside\nSMILES: ['[H][C@]1(C)OC(=O)[C@]([H])(CC(C)C)N(C)C(=O)[C@@]([H])(CC2=CC=C(C=C2)N2CCOCC2)OC(=O)[C@]([H])(CC(C)C)N(C)C(=O)[C@@]([H])(C)OC(=O)[C@]([H])(CC(C)C)N(C)C(=O)[C@@]([H])(CC2=CC=C(C=C2)N2CCOCC2)OC(=O)[C@]([H])(CC(C)C)N(C)C1=O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT04493931
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nDrug-drug Interaction Study of Gepotidacin\n\n**Trial Summary:** \n\n\n This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability\r\n study in adult healthy participants, including Japanese cohort. This study is designed to\r\n assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and\r\n establishing PK and safety in Japanese participants in cohort 4. Food effect will also be\r\n evaluated in cohort 4.\r\n \n\n**Trial Keywords:** ['Gepotidacin', 'Drug Interaction', 'Pharmacokinetic', 'Safety', 'Bacterial Infection', 'Japanese Healthy Adults']\n\n**Phase:** Phase 1\n\n**Condition:** Infections, Bacterial\n\n**Condition Keywords:** Bacterial Infections\n\n**ICD Code:** [\"['A49.9', 'A04.9', 'A04.8', 'A49.8']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 50 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Participant must be greater than or equal to (>=) 18 to less than or equal to (=<) 50\r\n years of age inclusive, at the time of signing the informed consent.\r\n\r\n - Participants who are healthy as determined by the investigator or medically qualified\r\n designee based on medical evaluation including medical history, physical examination,\r\n clinical laboratory tests, vital sign measurements, and 12-lead ECG results. A\r\n participant with clinical abnormality or laboratory parameters outside the reference\r\n range for the population being studied may be included only if the investigator feels\r\n and documents that the finding is unlikely to introduce additional risk factors and\r\n will not interfere with the study procedures.\r\n\r\n - Additional inclusion criteria for Japanese participants (Cohort 4): The participant is\r\n a non-naturalized Japanese citizen and holds a Japanese passport (current or expired).\r\n\r\n The participant has/had 2 Japanese parents and 4 Japanese grandparents who are/were all\r\n non-naturalized Japanese citizens, as confirmed by interview.\r\n\r\n The participant has been living outside of Japan for up to 10 years as confirmed by\r\n interview.\r\n\r\n - Participants have a body weight >=40 kilograms (kg) and body mass index within the\r\n range 18.5 to 32.0 kilograms per square meter (kg/m^2) (inclusive).\r\n\r\n - Male and/or female: Contraceptive use by men or women should be consistent with local\r\n regulations regarding the methods of contraception for those participating in clinical\r\n studies.\r\n\r\n 1. Female participants: A female participant is eligible to participate if she is\r\n not pregnant or breastfeeding, and 1 of the following conditions applies: Is a\r\n woman of non-childbearing potential or Is a woman of childbearing potential\r\n (WOCBP) and using a contraceptive method that is highly effective, with a failure\r\n rate of <1 percent (%), for at least 30 days prior to dosing until completion of\r\n the follow-up Visit. The investigator should evaluate the potential for\r\n contraceptive method failure (e.g., noncompliance, recently initiated) in\r\n relationship to the first dose of study intervention.\r\n\r\n A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by\r\n local regulations) before the first dose of study intervention and for women not on\r\n effective contraception at least 14 days prior to baseline visit.\r\n\r\n The investigator is responsible for review of medical history, menstrual history, and\r\n recent sexual activity to decrease the risk for inclusion of a woman with an early\r\n undetected pregnancy.\r\n\r\n - Capable of giving signed informed consent, which includes compliance with the\r\n requirements and restrictions listed in the informed consent form (ICF) and in the\r\n protocol.\r\n\r\n Exclusion Criteria:\r\n\r\n - Clinically significant abnormality in the past medical history or at the screening\r\n physical examination that in the investigator's opinion may place the participant at\r\n risk or interfere with the outcome variables of the study. This includes, but is not\r\n limited to, history or current cardiac, hepatic, renal, neurologic, gastro-intestinal\r\n (GI), respiratory, hematologic, or immunologic disease.\r\n\r\n - Any surgical or medical condition (active or chronic) that may interfere with drug\r\n absorption, distribution, metabolism, or excretion of the study intervention, or any\r\n other condition that may place the participant at risk, in the opinion of the\r\n investigator.\r\n\r\n - Female participant has a positive pregnancy test result or is lactating at Screening\r\n or upon admission to the clinic.\r\n\r\n - Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Note:\r\n Testing will be performed according to site procedures.\r\n\r\n - Within 2 months before Screening, either a confirmed history of Clostridium difficile\r\n (C. difficile) diarrhea infection or a past positive of C. difficile toxin test.\r\n\r\n - Current or chronic history of liver disease or known hepatic or biliary abnormalities\r\n (with the exception of Gilbert's syndrome or asymptomatic gallstones).\r\n\r\n - History of drug and/or alcohol abuse within 6 months before Screening, as determined\r\n by the investigator, or has a positive drug screen at Screening or upon admission to\r\n the clinic.\r\n\r\n - History of sensitivity/hypersensitivity to any of the study drugs, components thereof,\r\n or a history of drug or other allergy that, in the opinion of the Investigator or\r\n GlaxoSmithKline (GSK) Medical Monitor contraindicates their participation.\r\n\r\n - Cohort 2 Only: Participant is a contact lens wearer who is unable or unwilling to wear\r\n glasses for the duration of the study and for 5 half-lives after the last dose of\r\n rifampicin.\r\n\r\n - Use of any systemic antibiotic within 30 days of screening.\r\n\r\n - Participants must abstain from taking prescription or non-prescription drugs (except\r\n for hormonal contraceptives and/or acetaminophen at doses of <=2 grams/day), vitamins,\r\n and dietary or herbal supplements, within 7 days (or 14 days if the drug is a\r\n potential enzyme inducer) or 5 half-lives (whichever is longer) prior to study\r\n intervention until completion of the follow-up Visit, unless, in the opinion of the\r\n investigator and Sponsor, the medication will not interfere with the study. Any\r\n exceptions will be discussed with the Sponsor or Medical Monitor on a case-by-case\r\n basis and the reasons will be documented.\r\n\r\n - Previous exposure to gepotidacin.\r\n\r\n - Participant has participated in a clinical trial and has received an investigational\r\n product (IP) prior to gepotidacin administration within 30 days, 5 half-lives, or\r\n twice the duration of the biological effect of IP (whichever is longer).\r\n\r\n - Past participation in this clinical study.\r\n\r\n - Baseline corrected QT interval using the Fridericia formula (QTcF) of >450\r\n milliseconds (msec) at Screening or Check-in.\r\n\r\n - Presence of hepatitis B surface antigen or positive hepatitis C antibody test result\r\n at Screening or within 3 months prior to starting study intervention.\r\n\r\n - Alanine aminotransferase (ALT) >1.5 times upper limit of normal (ULN) at Screening or\r\n Check-in.\r\n\r\n - Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin\r\n is fractionated and direct bilirubin <35%) at Screening or Check-in.\r\n\r\n - History of any kidney disease or current or chronic history of mild impaired renal\r\n function as indicated by an estimated creatinine clearance <=90 milliliters per minute\r\n (mL/min).\r\n\r\n - A positive test for human immunodeficiency virus (HIV) antibody.\r\n\r\n - History of regular alcohol consumption within 6 months of Screening defined as an\r\n average weekly intake of >21 units (or an average daily intake of >3 units) for males\r\n or an average weekly intake of >14 units (or an average daily intake >2 units) for\r\n females. One unit is equivalent to 270 mL of full strength beer, 470 mL of light beer,\r\n 30 mL of spirits, or 100 mL of wine.\r\n\r\n - Cohort 3 Only: Digoxin-related exclusions include the following at Screening:\r\n\r\n Serum potassium >5.5 milliequivalent per liter (mEq/L) or < 3.6 mEq/L Serum magnesium <1.6\r\n milligrams per deciliter (mg/dL) Serum calcium (total) <8.5 mg/dL History of\r\n hypersensitivity to digoxin or other digitalis glycosides Any clinically relevant\r\n abnormality on 12-lead ECG at Screening or Check-in.\r\n\r\n - Participant has donated blood in excess of 500 mL within 12 weeks prior to dosing or\r\n participation in the study would result in donation of blood or blood products in\r\n excess of 500 mL within a 56-day period.\r\n\r\n - Participant is unable to comply with all study procedures, in the opinion of the\r\n investigator.\r\n\r\n - Participant should not participate in the study, in the opinion of the investigator or\r\n Sponsor.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Gepotidacin', 'Cimetidine', 'Rifampicin', 'Midazolam', 'Digoxin', 'Placebo matching to gepotidacin']\n- **Description:** ['Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.', 'Cimetidine tablets will be available as unit dose strength 400 mg and will be administered orally.', 'Rifampicin Capsules will be available as unit dose strength 300 mg and will be administered orally.', 'Midazolam oral syrup 2 milligrams per milliliter (mg/mL) will be available to be administered orally.', 'Digoxin tablets will be available as unit dose strength 0.25 mg and will be administered orally.', 'Placebo matching to gepotidacin tablets will be administered orally.']\n- **Mesh Terms:** ['Rifampin', 'Gepotidacin', 'Digoxin', 'Midazolam', 'Cimetidine']\nSMILES: ['O=C1C=CC2=C3N1C[C@@H](CN1CCC(CC1)NCC1=CC4=C(OCCC4)C=N1)N3C(=O)C=N2', 'CN\\\\C(NCCSCC1=C(C)NC=N1)=N\\\\C#N', 'CO[C@H]1\\\\C=C\\\\O[C@@]2(C)OC3=C(C2=O)C2=C(O)C(\\\\C=N\\\\N4CCN(C)CC4)=C(NC(=O)\\\\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)C(O)=C2C(O)=C3C', 'CC1=NC=C2CN=C(C3=CC=CC=C3F)C3=C(C=CC(Cl)=C3)N12', '[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1', 'O=C1C=CC2=C3N1C[C@@H](CN1CCC(CC1)NCC1=CC4=C(OCCC4)C=N1)N3C(=O)C=N2']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04537910
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of LY3819253 (LY-CoV555) in Healthy Participants\n\n**Trial Summary:** \n\n\n The purpose of this study is to test the safety and tolerability of LY3819253 when it is\r\n given by injection just under the skin to healthy participants. Blood tests will be done to\r\n check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it.\r\n Participation could last up to 16 weeks and may include up to six visits to the study center,\r\n with a one-week overnight stay.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 60 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Are overtly healthy as determined by medical evaluation including medical history and\r\n physical examination\r\n\r\n - Are willing to follow study procedures, including having nasal or nasopharyngeal swabs\r\n collected\r\n\r\n - Have a body mass index (BMI) within the range of greater than or equal to (≥)18.5 to\r\n less than (<)35 kilograms per square meter (kg/m²)\r\n\r\n - Male participants must agree to adhere to contraception restrictions\r\n\r\n - Female participants must be of non-childbearing potential\r\n\r\n Exclusion Criteria:\r\n\r\n - Have or have had known or suspected severe acute respiratory syndrome coronavirus 2\r\n (SARS-CoV-2) infection\r\n\r\n - Have a history or presence of cardiovascular (including hypertension), respiratory,\r\n hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or\r\n neurological disorders that, in the opinion of the investigator, are capable of\r\n\r\n - Significantly altering the absorption, metabolism, or elimination of drugs\r\n\r\n - Constituting a risk while taking the investigational product, or\r\n\r\n - Interfering with the interpretation of data\r\n\r\n - Have significant allergies to humanized monoclonal antibodies (mAbs)\r\n\r\n - Have any of the following that are clinically significant:\r\n\r\n - Multiple or severe drug allergies, or\r\n\r\n - Intolerance to topical corticosteroids, or\r\n\r\n - Severe posttreatment hypersensitivity reactions (including, but not limited to,\r\n erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal\r\n necrolysis, or exfoliative dermatitis)\r\n\r\n - Have had lymphoma, leukemia, or any malignancy within the past 5 years, except for\r\n basal cell or squamous epithelial carcinomas of the skin that have been resected with\r\n no evidence of metastatic disease for 3 years\r\n\r\n - Have had breast cancer within the past 10 years\r\n\r\n - Show evidence of human immunodeficiency virus (HIV) infection and/or positive human\r\n HIV antibodies\r\n\r\n - Show evidence of current hepatitis C (that is, test positive for anti-hepatitis C\r\n antibody with confirmed presence of hepatitis C virus [HCV] ribonucleic acid [RNA])\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['LY3819253', 'Placebo']\n- **Description:** ['Administered SC.', 'Administered SC.']\n- **Mesh Terms:** Bamlanivimab\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT01887587
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nVincristine, Doxorubicin, And Dexamethasone + Ixazomib in Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia\n\n**Trial Summary:** \n\n\n This is a phase I study of vincristine, doxorubicin and dexamethasone (modified VXD) plus\r\n MLN9708 in adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma,\r\n lymphoblastic lymphoma or mixed phenotype acute leukemia.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Relapsed or Refractory Acute Lymphoblastic Leukemia', 'Relapsed or Refractory Lymphoblastic Lymphoma', 'Mixed Phenotype Acute Leukemia']\n\n**Condition Keywords:** ['Lymphoma', 'Leukemia', 'Precursor Cell Lymphoblastic Leukemia-Lymphoma', 'Leukemia, Lymphoid', 'Lymphoma, Non-Hodgkin', 'Acute Disease']\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Each patient must meet all of the following inclusion criteria to be enrolled in the study:\r\n\r\n Inclusion\r\n\r\n - Male or female patients 18 years or older\r\n\r\n - Have relapsed B or T-precursor acute lymphocytic leukemia/lymphoma, lymphoblastic\r\n lymphoma or mixed phenotype acute leukemia with increased bone marrow or peripheral\r\n blood blasts by morphology with or without CNS involvement\r\n\r\n - Prior therapy: At least two prior treatment attempts to induce remission with no limit\r\n on the number of prior treatment regimens.\r\n\r\n - Patients are eligible after allogeneic stem cell transplantation\r\n\r\n - Eastern Cooperative Oncology Group (ECOG) performance status 0-2\r\n\r\n - Patients must meet the following clinical laboratory criteria:\r\n\r\n - Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN).\r\n\r\n - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.\r\n\r\n - Calculated creatinine clearance ≥ 30 mL/min\r\n\r\n - Absolute neutrophil count (ANC) > 1,000/cmm and platelets > 75,000/cmm unless the\r\n cytopenias are secondary to disease\r\n\r\n - Life expectancy reasonably adequate for evaluating the treatment effect\r\n\r\n - Patients must be at least 2 weeks from major surgery, radiation therapy, participation\r\n in other investigational trials and have recovered from clinically significant\r\n toxicities of these prior treatments\r\n\r\n - Female patients who:\r\n\r\n - Are postmenopausal for at least 1 year before the screening visit, OR\r\n\r\n - Are surgically sterile, OR\r\n\r\n - If they are of childbearing potential, agree to practice 2 effective methods of\r\n contraception, at the same time, from the time of signing the informed consent\r\n form through 90 days after the last dose of study drug, OR\r\n\r\n - Agree to practice true abstinence when this is in line with the preferred and\r\n usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,\r\n symptothermal, post-ovulation methods] and withdrawal are not acceptable methods\r\n of contraception.)\r\n\r\n - Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree\r\n to one of the following:\r\n\r\n - Agree to practice effective barrier contraception during the entire study\r\n treatment period and through 90 days after the last dose of study drug, OR\r\n\r\n - Agree to practice true abstinence when this is in line with the preferred and\r\n usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation,\r\n symptothermal, post-ovulation methods] and withdrawal are not acceptable methods\r\n of contraception.).\r\n\r\n Exclusion Criteria:\r\n\r\n Patients meeting any of the following exclusion criteria are not to be enrolled in the\r\n study:\r\n\r\n - Patients who are Ph+ ALL who are naive to therapy with an approved tyrosine kinase\r\n inhibitor.\r\n\r\n - Prior exposure to ≥350 mg/m2 of anthracycline (in doxorubicin equivalent dosing), or\r\n left ventricular fractional shortening less than 50%.\r\n\r\n - Failure to have fully recovered (ie, ≤ Grade 2 toxicity) from the effects of prior\r\n chemotherapy regardless of the interval since last treatment.\r\n\r\n - Major surgery within 14 days before enrollment.\r\n\r\n - Chemotherapy in the last 14 days. (Steroids or Intrathecal chemotherapy will be\r\n allowed).\r\n\r\n - Systemic treatment, within 7 days before study enrollment, with strong inhibitors of\r\n cytochrome P450 1A2 (CYP1A2) (e.g., fluvoxamine, enoxacin, ciprofloxacin), strong\r\n inhibitors of cytochrome P4503A (CYP3A) (e.g., clarithromycin, telithromycin,\r\n itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A\r\n inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital),\r\n or use of Ginkgo biloba or St. John's wort.\r\n\r\n - Uncontrolled intercurrent illness including, but not limited to ongoing or active\r\n infection, symptomatic congestive heart failure, or psychiatric illness/social\r\n situations that would limit compliance with study requirements. Patients receiving\r\n intravenous antibiotics for infections that are under control may be included in this\r\n study.\r\n\r\n - Known allergy to any of the study medications, their analogues, or excipients in the\r\n various formulations of any agent.\r\n\r\n - Inability to swallow oral medication, inability or unwillingness to comply with the\r\n drug administration requirements, or GI procedure that could interfere with the oral\r\n absorption or tolerance of treatment.\r\n\r\n - Diagnosed or treated for another malignancy within 2 years before study enrollment or\r\n previously diagnosed with another malignancy and have any evidence of residual\r\n disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are\r\n not excluded if they have undergone complete resection.\r\n\r\n - Patient has ≥ Grade 2 peripheral neuropathy.\r\n\r\n - Participation in clinical trials with other investigational agents not included in\r\n this trial, within 14 days of the start of this trial and throughout the duration of\r\n this trial.\r\n\r\n - Female patients who are breastfeeding or have a positive serum pregnancy test during\r\n the screening period or a positive urine pregnancy test on Day 1 before first dose of\r\n study drug.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['MLN9708', 'Vincristine', 'Doxorubicin', 'Dexamethasone']\n- **Description:** None\n- **Mesh Terms:** ['Dexamethasone', 'Doxorubicin', 'Vincristine', 'Ixazomib']\nSMILES: ['[H][C@@]12N3CC[C@@]11C4=C(C=C(OC)C(=C4)[C@]4(C[C@H]5C[N@](C[C@](O)(CC)C5)CCC5=C4NC4=CC=CC=C54)C(=O)OC)N(C=O)[C@@]1([H])[C@](O)([C@H](OC(C)=O)[C@]2(CC)C=CC3)C(=O)OC', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT04343092
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEffectiveness of Ivermectin as add-on Therapy in COVID-19 Management\n\n**Trial Summary:** \n\n\n Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group\r\n to Hydroxychloroquin (HCQ) + azithromycin (AZT)\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** COVID 19\n\n**Condition Keywords:** COVID-19\n\n**ICD Code:** [\"['U07.1', 'Z28.310', 'Z28.311', 'Z86.16', 'U09.9', 'Z11.52', 'Z20.822']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n -1. Patients with age above 18 years and any gender with definite Dx of covid19 and\r\n pneumonia in the ward according to the clinical, laboratory, and imaging criteria.\r\n\r\n 2. Understands and agrees to comply with planned study procedures.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Patients with hypersensitivity or severe adverse effects to Ivermectin\r\n\r\n 2. Renal impairment\r\n\r\n 3. Hepatic impairment.\r\n\r\n 4. Pregnancy or a desire to become pregnant (drug considered pregnancy category c)\r\n\r\n 5. Breast feeding.\r\n\r\n 6. Patient with covid 19 positive and mild no pneumonia\r\n\r\n 7. Children under the age of five or those who weigh less than 15 kilograms\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Ivermectin (IVM)\n- **Description:** Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly\n- **Mesh Terms:** Ivermectin\nSMILES: ['[H][C@@]12OC\\\\C3=C/C=C/[C@H](C)[C@H](O[C@H]4C[C@H](OC)[C@@H](O[C@H]5C[C@H](OC)[C@@H](O)[C@H](C)O5)[C@H](C)O4)\\\\C(C)=C\\\\C[C@]4([H])C[C@@]([H])(C[C@]5(CC[C@H](C)[C@]([H])(O5)C(C)C)O4)OC(=O)[C@]([H])(C=C(C)[C@H]1O)[C@@]23O.[H][C@@]12OC\\\\C3=C/C=C/[C@H](C)[C@H](O[C@H]4C[C@H](OC)[C@@H](O[C@H]5C[C@H](OC)[C@@H](O)[C@H](C)O5)[C@H](C)O4)\\\\C(C)=C\\\\C[C@]4([H])C[C@@]([H])(C[C@]5(CC[C@H](C)[C@]([H])(O5)[C@@H](C)CC)O4)OC(=O)[C@]([H])(C=C(C)[C@H]1O)[C@@]23O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02377752
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of Olaratumab in Japanese Participants With Advanced Cancer\n\n**Trial Summary:** \n\n\n This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate\r\n safety and side effects of olaratumab in combination with doxorubicin in Japanese\r\n participants with a group of rare cancers (advanced solid tumors, especially advanced soft\r\n tissue sarcoma [STS].) The main purpose of Part B is to evaluate how much olaratumab gets\r\n into the blood stream of Japanese participants with advanced solid tumors and how long it\r\n takes the body to get rid of it.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Neoplasm\n\n**Condition Keywords:** None\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 20 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Part A: Have histological or cytological evidence of a diagnosis of advanced or\r\n metastatic solid tumor, especially STS, which is not amenable to treatment with\r\n surgery or radiotherapy. Part B: Have histological or cytological evidence of a\r\n diagnosis of solid tumor that is advanced or metastatic.\r\n\r\n - Have the presence of measurable or nonmeasurable disease as defined by the Response\r\n Evaluation Criteria in Solid Tumors (RECIST).\r\n\r\n - Have given written informed consent prior to any study-specific procedures.\r\n\r\n - Have adequate organ and coagulation function\r\n\r\n - Have an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of less than\r\n or equal to 1.\r\n\r\n - Have discontinued previous treatments for cancer and recovered from the acute effects\r\n of therapy.\r\n\r\n - (Part A only) Have a prestudy echocardiogram with an actual left ventricular ejection\r\n fraction greater than or equal to 50%, within 21 days prior to first dose of study\r\n medication.\r\n\r\n - All participants agree to use a reliable method of birth control and to not donate\r\n sperm during the study and for at least 3 months following last dose of study drug.\r\n\r\n - Female participants:\r\n\r\n - must either be women not of child-bearing potential due to surgical sterilization\r\n confirmed by medical history, or menopause or\r\n\r\n - women of child-bearing potential who test negative for pregnancy within 7 days\r\n before the first dose of study drug based on serum or urine pregnancy test and\r\n agree not to breast feed during the study and for 3 months following the last\r\n dose of the study drug(s)\r\n\r\n - Have an estimated life expectancy of more than or equal to 3 months in the judgment of\r\n the investigator.\r\n\r\n Exclusion Criteria:\r\n\r\n - Have received treatment within 21 days of the initial dose of study drug with an\r\n investigational product or non-approved use of a drug or device for non-cancer\r\n indications or are concurrently enrolled in any other type of medical research judged\r\n not to be scientifically or medically compatible with this study.\r\n\r\n - (Part A only) Have received prior treatment with doxorubicin, daunorubicin,\r\n idarubicin, and/or other anthracyclines and anthracenediones\r\n\r\n - (Part A only) Have received prior radiation therapy to the mediastinal/pericardial\r\n area.\r\n\r\n - Have symptomatic central nervous system malignancy or metastasis. Participants with\r\n treated central nervous system (CNS) metastases are eligible for this study if they\r\n are not currently receiving corticosteroids and/or anticonvulsants, and their disease\r\n is asymptomatic and radiographically stable for at least 60 days.\r\n\r\n - Have an elective or a planned major surgery to be performed during the course of the\r\n study.\r\n\r\n - Have an uncontrolled intercurrent illness including, but not limited to, symptomatic\r\n congestive heart failure greater than class II of the New York Heart Association\r\n guideline, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric\r\n illness/social situations that would limit compliance with study requirements.\r\n\r\n - Have unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction\r\n 6 months prior to study entry.\r\n\r\n - Have a known allergy to any of the treatment components.\r\n\r\n - Have a history of allergic reactions attributed to compounds of chemical or biologic\r\n composition similar to that of olaratumab.\r\n\r\n - Have a known active fungal, bacterial, and/or known viral infection\r\n\r\n - Have a corrected QT interval of greater than 470 milliseconds (msec) on screening\r\n electrocardiogram (ECG)\r\n\r\n - Have a second primary malignancy that, in the judgment of the investigator and\r\n sponsor, may affect the interpretation of results.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Olaratumab', 'Doxorubicin']\n- **Description:** ['Administered IV', 'Administered IV']\n- **Mesh Terms:** ['Doxorubicin', 'Olaratumab']\nSMILES: ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03422172
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men\n\n**Trial Summary:** \n\n\n The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for\r\n prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor\r\n currently in development for treatment and prevention of HIV infection. CAB possesses\r\n attributes that allow formulation and delivery as a LA parenteral product. CAB is being\r\n developed as both oral and long acting (LA) injectable formulations. This study is designed\r\n to evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected\r\n Chinese male subjects at low risk for HIV acquisition. Eligible subjects will receive oral\r\n CAB during oral phase of the study followed by CAB LA intramuscular (IM) injection during\r\n injection phase of the study. Approximately 60 subjects will be screened, of which,\r\n approximately 48 subjects will enter the oral phase and 40 subjects will enter the injection\r\n phase of the study. The maximum study duration will be approximately 89 weeks including oral\r\n phase, injection phase and follow-up phase.\r\n \n\n**Trial Keywords:** ['GSK1265744', 'Pre-Exposure Prophylaxis', 'Human immunodeficiency virus', 'Cabotegravir', 'Pharmacokinetics']\n\n**Phase:** Phase 1\n\n**Condition:** HIV Infections\n\n**Condition Keywords:** HIV Infections\n\n**ICD Code:** [\"['Z21']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Subjects must be 18 to 65 years of age inclusive, at the time of signing the informed\r\n consent.\r\n\r\n - Subjects are male at birth.\r\n\r\n - Subjects who have non-reactive point of care (POC) HIV test and undetectable HIV-1\r\n ribose nucleic acid (RNA) at screening.\r\n\r\n - At risk of acquiring HIV, defined as having at least one casual male or female sex\r\n partner in the past 24 months.\r\n\r\n - Healthy as determined by a responsible and experienced physician, based on a medical\r\n evaluation including medical history, physical examination, laboratory tests and\r\n cardiac monitoring at the time of screening.\r\n\r\n - Capable of giving written informed consent.\r\n\r\n - Agree to appropriate use of contraceptive measures during heterosexual intercourse.\r\n All subjects should be counseled on safer sexual practices including the use and\r\n benefit/risk of effective barrier methods (example given (e.g.), male condom) to\r\n reduce the risk of sexually transmitted infections.\r\n\r\n - Willing to undergo all required study procedures.\r\n\r\n Exclusion Criteria:\r\n\r\n - Current or chronic history of liver disease, or known hepatic or biliary abnormalities\r\n (with the exception of Gilbert's syndrome or asymptomatic gallstones).\r\n\r\n - History of the following cardiac diseases: myocardial infarction, congestive heart\r\n failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia.\r\n\r\n - Active skin disease or disorder (that is [i.e.], infection, inflammation, dermatitis,\r\n eczema, drug rash, psoriasis, urticaria). Mild cases of localized acne or folliculitis\r\n or other mild skin condition may not be exclusionary at the discretion of the\r\n Investigator of Record or Medical Monitor.\r\n\r\n - Subjects determined by the Investigator to have a high risk of seizures, including\r\n subjects with an unstable or poorly controlled seizure disorder. A subject with a\r\n prior history of seizure may be considered for enrolment if the Investigator believes\r\n the risk of seizure recurrence is low. All cases of prior seizure history should be\r\n discussed with the Medical Monitor prior to enrolment.\r\n\r\n - Any medical condition, including psychiatric conditions that in the judgment of the\r\n investigator would interfere with the subject's ability to complete study procedures.\r\n\r\n - Subjects who, in the investigator's judgment, poses a significant suicide risk.\r\n\r\n - Use of antiretroviral (ARV) therapy (e.g., for Post exposure prophylaxis [PEP] or\r\n PrEP) in the past 30 days.\r\n\r\n - Use of high dose aspirin or any other anticoagulant or antiplatelet medication that\r\n would interfere with the ability to receive IM injections.\r\n\r\n - Assessed by the Investigator of Record or designee as being at \"high risk\" for HIV\r\n infection. This may include one or more of the following: the negative partner in an\r\n HIV serodiscordant couple where the HIV infected partner is not suppressed; men who\r\n exchange sex for goods or money; men who have engaged in any condomless anal\r\n intercourse within the past 6 months; men who have had greater than 5 male or female\r\n sexual partners within the past 6 months; men who have had a sexually transmitted\r\n disease within the past 6 months; any other behavior assessed by the investigator as\r\n \"high risk\".\r\n\r\n - History of drug or alcohol consumption that in the opinion of the Principal\r\n Investigator will interfere with study participation.\r\n\r\n - Ongoing intravenous drug use - episodic use or any use in the past 90 days is\r\n exclusionary (as assessed by the study investigator).\r\n\r\n - One or more reactive HIV test results at screening or enrolment, even if HIV infection\r\n is not confirmed. Negative HIV RNA must also be documented at screening.\r\n\r\n - Co-enrolment in any other HIV interventional research study (provided by self-report\r\n or other available documentation) or prior enrolment and receipt of the active arm\r\n (i.e., NOT a placebo) of a HIV vaccine trial (provided by available documentation).\r\n\r\n - Any of the following laboratory values during the screening period: positive hepatitis\r\n C antibody result; positive Hepatitis B surface antigen (HBsAg); hemoglobin <11 grams\r\n per deciliter (g/dL); absolute neutrophil count <750 cells/ cubic millimeter (mm^3);\r\n platelet count <=100,000 cells/mm^3; presence of a coagulopathy as defined by an\r\n international normalized ratio(INR)>1.5 or a partial thromboplastin time (PTT) >45\r\n seconds; calculated creatinine clearance <60 milliliter/minute (mL/minute) using the\r\n Cockcroft-Gault equation; a single repeat test is allowed during the screening period\r\n to verify a result, with the exception of HIV tests.\r\n\r\n - Subjects with an ALT, alkaline phosphatase or bilirubin >=1.5x Upper limit of normal\r\n (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and\r\n direct bilirubin <35 percent).\r\n\r\n - The subject has a tattoo or other dermatological condition overlying the gluteus\r\n region which may interfere with interpretation of injection site reactions.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Oral CAB', 'CAB LA']\n- **Description:** ['CAB tablet will be formulated as white to almost white, oval shaped, film coated 30 mg tablets, administered orally once daily. The CAB tablets will be packaged in bottles containing 30 tablets each.', 'CAB LA is a sterile white to slightly colored suspension containing 200 mg/mL of CAB as free acid for administration by IM injection in gluteus medius.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03599518
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nDS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer\n\n**Trial Summary:** \n\n\n This study has two parts: dose escalation and dose expansion.\r\n\r\n The primary objectives are:\r\n\r\n - For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined\r\n with gefitinib in the study population and to determine the recommended dose for\r\n expansion of DS-1205c when combined with gefitinib in the study population\r\n\r\n - For Dose Expansion, to assess the safety and tolerability of DS-1205c when combined with\r\n gefitinib in the study population.\r\n\r\n In Dose Escalation, after a 7-day run in period (Cycle 0), there will be 21-day cycles (Cycle\r\n 1 onward). In Dose Expansion, there will be 21-day cycles.\r\n\r\n The number of treatment cycles is not fixed in this study. Participants will continue study\r\n treatment for 36 months unless they decide not to (withdraw consent), their disease gets\r\n worse [progressive disease (PD)], or side effects become unacceptable (unacceptable\r\n toxicity).\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Non Small Cell Lung Cancer\n\n**Condition Keywords:** ['Lung Neoplasms', 'Carcinoma, Non-Small-Cell Lung']\n\n**ICD Code:** [\"['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 20 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Has histologically or cytologically documented adenocarcinoma NSCLC\r\n\r\n 2. Has locally advanced or metastatic NSCLC, not amenable to curative surgery or\r\n radiation\r\n\r\n 3. Has acquired resistance to EGFR tyrosine kinase inhibitor (TKI) according to the\r\n Jackman criteria (PMID: 19949011):\r\n\r\n 1. Historical confirmation that the tumor harbors an EGFR mutation known to be\r\n associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R,\r\n L861Q) OR\r\n\r\n 2. Has experienced clinical benefit from an EGFR TKI, followed by systemic\r\n progression [Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) or\r\n World Health Organization (WHO)] while on continuous treatment with an EGFR TKI\r\n\r\n 4. Is currently receiving and able to interrupt gefitinib or discontinue erlotinib,\r\n afatinib, or osimertinib\r\n\r\n 5. Has been receiving gefitinib, erlotinib, afatinib, or osimertinib for at least 6 weeks\r\n with well-controlled related toxicities less than Grade 3 in severity at the time of\r\n screening period; participants who have been receiving gefitinib must be taking\r\n gefitinib at a dose of 250 mg/day\r\n\r\n 6. Has radiological documentation of disease progression while receiving continuous\r\n treatment with gefitinib, erlotinib, afatinib, or osimertinib\r\n\r\n 7. Has at least one measurable lesion per RECIST version 1.1\r\n\r\n 8. Is willing to provide archival tumor tissue from a biopsy performed after progression\r\n during treatment with gefitinib, erlotinib, afatinib, or osimertinib OR has at least\r\n one lesion, not previously irradiated, amenable to core biopsy and is willing to\r\n undergo screening tumor biopsy\r\n\r\n 9. Demonstrates absence of EGFR T790M mutation in tumor tissue since progression during\r\n gefitinib, erlotinib, afatinib, or osimertinib treatment\r\n\r\n 10. Has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, with\r\n no deterioration over the previous 2 weeks\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Has any evidence of small cell histology, or combined small cell and non-small cell\r\n histology, in original tumor biopsy or in screening biopsy performed since progression\r\n\r\n 2. Has previously documented evidence of anaplastic lymphoma kinase (ALK) fusion, ROS\r\n proto-oncogene 1 (ROS1) fusion, BRAF V600E mutation, rearranged during transfection\r\n (RET) rearrangement, human epidermal growth factor receptor 2 (HER2) mutation, or MET\r\n exon 14 skipping mutation - no new testing for these genomic alterations is required\r\n for Screening\r\n\r\n 3. Has received treatment with any of the following:\r\n\r\n 1. Any cytotoxic chemotherapy, immune checkpoint inhibitor therapy, investigational\r\n agent or other anticancer drug(s) from a previous cancer treatment regimen or\r\n clinical study (other than EGFR TKI), within 14 days of the first dose of study\r\n treatment\r\n\r\n 2. Immune checkpoint inhibitor therapy within 30 days of first dose of study\r\n treatment\r\n\r\n 3. Major surgery (excluding placement of vascular access) within 4 weeks of the\r\n first dose of study treatment\r\n\r\n 4. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field\r\n of radiation within 4 weeks, or palliative radiation therapy within 2 weeks of\r\n the first dose of study drug treatment\r\n\r\n 4. Has history of other active malignancy within 3 years prior to enrollment, except:\r\n\r\n 1. Adequately treated non-melanoma skin cancer OR\r\n\r\n 2. Superficial bladder tumors (Tumor stage \"a\" [Ta], Tumor stage \"is\" [Tis], Tumor\r\n stage \"1\" [T1]) OR\r\n\r\n 3. Curatively treated in situ disease OR\r\n\r\n 4. Low-risk non-metastatic prostate cancer (with Gleason score < 7 on antiandrogen\r\n therapy)\r\n\r\n 5. Has spinal cord compression or clinically active brain metastases, defined as\r\n untreated and symptomatic, or requiring therapy with corticosteroids or\r\n anticonvulsants to control associated symptoms - Subjects with clinically inactive\r\n brain metastases may be included in the study. Subjects with treated brain metastases\r\n that are no longer symptomatic and who require no treatment with corticosteroids or\r\n anticonvulsants may be included in the study if they have recovered from the acute\r\n toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end\r\n of whole brain radiotherapy and study enrollment (1 week for stereotactic\r\n radiotherapy).\r\n\r\n 6. Has retinal disease in the eye that is not due to neovascular age-related macular\r\n degeneration (nAMD; eg, significant diabetic retinopathy, glaucomatous retinal\r\n atrophy, retinal detachment)\r\n\r\n 7. Has history of myocardial infarction within the past 6 months\r\n\r\n 8. Has symptomatic congestive heart failure [New York Heart Association (NYHA) Classes\r\n II-IV], unstable angina, or cardiac arrhythmia requiring antiarrhythmic treatment\r\n\r\n 9. Has left ventricular ejection fraction (LVEF) < 45% by either echocardiogram (ECHO) or\r\n multigated acquisition (MUGA) scan\r\n\r\n 10. Has any clinically important abnormalities in rhythm, conduction or morphology of\r\n resting ECG, eg, complete left bundle branch block, third-degree heart block,\r\n second-degree heart block, or PR interval > 250 milliseconds (ms)\r\n\r\n 11. Has a mean corrected QT interval using Fridericia's correction (QTcF) prolongation\r\n >470 ms for females and >450 ms for males in three successive Screening measurements\r\n\r\n 12. Unable or unwilling to discontinue concomitant use of drugs that are known to prolong\r\n the QT interval\r\n\r\n 13. Has any factors that increase the risk of QTc prolongation or risk of arrhythmic\r\n events, such as congenital long QT. syndrome, family history of long QT syndrome or\r\n unexplained sudden death under 40 years of age in first degree relatives\r\n\r\n 14. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that\r\n required corticosteroid treatment, has current ILD/pneumonitis, or has suspected\r\n ILD/pneumonitis which cannot be ruled out by imaging at screening\r\n\r\n 15. Has history of pancreatitis within the past 6 months\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['DS-1205c', 'Gefitinib']\n- **Description:** ['DS-1205c 200 mg capsule for oral administration', 'Gefitinib 250 mg tablet for oral administration']\n- **Mesh Terms:** Gefitinib\nSMILES: ['COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03483506
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nThis Study in Healthy Men Tests How the Body Takes up BI 1467335\n\n**Trial Summary:** \n\n\n The primary objective of this trial is to investigate the absolute bioavailability of BI\r\n 1467335 with an intravenous microdose formulation containing labelled [C-14] BI 1467335 and\r\n an unlabelled oral tablet formulation of BI 1467335 in healthy male subjects.\r\n\r\n The secondary objective is the evaluation of additional pharmacokinetic parameters following\r\n the two treatments.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Healthy male subjects according to the investigator's assessment, based on a complete\r\n medical history including a physical examination, vital signs (Blood pressure (BP),\r\n Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests\r\n\r\n - Age of 18 to 65 years (incl.)\r\n\r\n - Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)\r\n\r\n - Signed and dated written informed consent prior to admission to the study in\r\n accordance with Good Clinical Practice (GCP) and local legislation\r\n\r\n - Subjects who are sexually active must use, with their partner, highly effective\r\n contraception from the time of administration of trial medication until 4 months after\r\n administration of trial medication. Adequate methods are:\r\n\r\n - Condoms plus use of hormonal contraception by the female partner that started at\r\n least 2 months prior to administration of trial medication (e.g., implants,\r\n injectables, combined oral or vaginal contraceptives, intrauterine device) or\r\n\r\n - Condoms plus surgical sterilization (vasectomy at least 1 year prior to\r\n enrolment) or\r\n\r\n - Condoms plus surgically sterilised partner (including hysterectomy) or\r\n\r\n - Condoms plus intrauterine device or\r\n\r\n - Condoms plus partner of non-childbearing potential (including homosexual men)\r\n study drug via seminal fluid Alternatively, true abstinence is acceptable when it\r\n is in line with the subject's preferred and usual lifestyle. If a subject is\r\n usually not sexually active but becomes active, with their partner, they must\r\n comply with the contraceptive requirements detailed above\r\n\r\n Exclusion Criteria:\r\n\r\n - Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR)\r\n or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant\r\n by the investigator\r\n\r\n - Any laboratory value outside the reference range that the investigator considers to be\r\n of clinical relevance\r\n\r\n - Any evidence of a concomitant disease judged as clinically relevant by the\r\n investigator\r\n\r\n - Clinically significant gastrointestinal, hepatic, renal, respiratory (including but\r\n not limited to interstitial lung disease), cardiovascular, metabolic, immunological or\r\n hormonal disorders\r\n\r\n - Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with\r\n the pharmacokinetics of the trial medication (except appendectomy and simple hernia\r\n repair)\r\n\r\n - Diseases of the central nervous system (including but not limited to any kind of\r\n seizures or stroke), and other relevant neurological or psychiatric disorders\r\n\r\n - History of relevant orthostatic hypotension, fainting spells, or blackouts\r\n\r\n - Chronic or relevant acute infections\r\n\r\n - History of relevant allergy or hypersensitivity (including allergy to the trial\r\n medication or its excipients)\r\n\r\n - Within 30 days prior to administration of trial medication, use of drugs that might\r\n reasonably influence the results of the trial or that might prolong the QT/QTc\r\n interval\r\n\r\n - Participation in another trial where an investigational drug has been administered\r\n within 60 days prior to planned administration of trial medication, or current\r\n participation in another trial involving administration of investigational drug\r\n\r\n - Smoker (more than 5 cigarettes or 1 cigar or 1 pipe per day)\r\n\r\n - Inability to refrain from smoking on specified trial days\r\n\r\n - Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals\r\n approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)e the reference range\r\n that the investigator considers to be of clinical relevance\r\n\r\n - Drug abuse or positive drug screening\r\n\r\n - Blood donation of more than 100 mL within 30 days prior to administration of trial\r\n medication or intended donation during the trial\r\n\r\n - Inability to comply with dietary regimen of trial site\r\n\r\n - A marked baseline prolongation of QT/QTc interval (such as QTcF intervals that are\r\n repeatedly greater than 450 ms) or any other relevant ECG finding at screening\r\n\r\n - A history of additional risk factors for Torsades de Pointes (such as heart failure,\r\n hypokalemia, or family history of Long QT Syndrome)\r\n\r\n - Subject is assessed as unsuitable for inclusion by the investigator, for instance,\r\n because considered not able to understand and comply with study requirements, or has a\r\n condition that would not allow safe participation in the study\r\n\r\n In addition, the following trial-specific exclusion criteria apply:\r\n\r\n - Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of\r\n thorax and bony skeleton (excluding spinal column) in the period of 1 year prior to\r\n screening\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['BI 1467335', 'BI 1467335 (C-14) intravenous solution']\n- **Description:** ['Film-coated tablet', 'Intravenous solution']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT00742001
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nFeasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival\n\n**Trial Summary:** \n\n\n Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from\r\n Mirasol-treated whole blood\r\n \n\n**Trial Keywords:** ['red blood cells', 'transfusion', 'recovery', 'feasibility', 'white blood cell inactivation']\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - healthy adults who meet AABB (formerly known as the American Association of Blood\r\n Banks) criteria for whole blood donation\r\n\r\n - females incapable of becoming pregnant\r\n\r\n - males agreeing to use contraception during trial\r\n\r\n Exclusion Criteria:\r\n\r\n - pregnancy or nursing\r\n\r\n - abnormal medical history (bleeding disorders, anemia, myocardial ischemia,\r\n uncontrolled hypertension, heart disease, epilepsy)\r\n\r\n - major surgery\r\n\r\n - use of drugs affecting coagulation or RBC function\r\n\r\n - recent participation in other trials which may confound results\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Mirasol System for Whole Blood.\n- **Description:** Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04081337
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide\n\n**Trial Summary:** \n\n\n This is a study of tirzepatide in participants with obesity. The main purpose is to learn\r\n more about how tirzepatide affects the number of calories participants burn and the amount of\r\n food they eat. The study lasted for 28 weeks and will include about 21 visits to the study\r\n center.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Obesity\n\n**Condition Keywords:** Obesity\n\n**ICD Code:** [\"['E66.8', 'E66.9', 'E66.1', 'O99.214', 'O99.215', 'O99.210', 'O99.211']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 60 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive\r\n\r\n - Have a stable body weight in the past 1 month prior to screening\r\n\r\n - Willing and agreeable to commit to the duration of the study and undergo study\r\n procedures as instructed by the clinic staff\r\n\r\n Exclusion Criteria:\r\n\r\n - Have undergone gastric bypass or bariatric surgery\r\n\r\n - Have a diagnosis of type 2 diabetes\r\n\r\n - Have a history or current cardiovascular, respiratory, hepatic, renal,\r\n gastrointestinal, endocrine, hematological or neurological disorders capable of\r\n significantly altering the absorption, metabolism or elimination of drugs; of\r\n constituting a risk when taking the study drug; or of interfering with the\r\n interpretation of data\r\n\r\n - Have received prescription drugs or over the counter drugs that promote weight loss in\r\n the past 6 months prior to screening\r\n\r\n - Have any lifetime history of a suicide attempt\r\n\r\n - Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening\r\n\r\n - Positive responses to selected items on the Columbia Suicide Severity Rating Scale\r\n (C-SSRS)\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Tirzepatide', 'Placebo']\n- **Description:** ['Administered SC', 'Administered SC']\n- **Mesh Terms:** Tirzepatide\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02567656
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma\n\n**Trial Summary:** \n\n\n The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K\r\n delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.\r\n \n\n**Trial Keywords:** ['CTCL', 'PTCL', 'RP6530']\n\n**Phase:** Phase 1\n\n**Condition:** ['Lymphoma, T-Cell, Peripheral', 'Lymphoma, T-Cell, Cutaneous']\n\n**Condition Keywords:** ['Lymphoma', 'Lymphoma, T-Cell', 'Lymphoma, T-Cell, Peripheral', 'Lymphoma, T-Cell, Cutaneous']\n\n**ICD Code:** [\"['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']\", \"['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL)\r\n\r\n - Refractory to or relapsed after at least 1 prior treatment line.\r\n\r\n - ECOG performance status ≤2\r\n\r\n - Patients must be ≥18 years of age\r\n\r\n - Able to give a written informed consent.\r\n\r\n Exclusion Criteria:\r\n\r\n - Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks\r\n\r\n - Patients with HBV, HCV or HIV infection\r\n\r\n - Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or\r\n any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus),\r\n AKT or BTK Inhibitor (including Ibrutinib) in last 6 months\r\n\r\n - Patients on immunosuppressive therapy including systemic corticosteroids.\r\n\r\n - Patients with known history of liver disorders.\r\n\r\n - Patients with uncontrolled Diabetes Type I or Type II\r\n\r\n - Any severe and/or uncontrolled medical conditions or other conditions that could\r\n affect their participation in the study.\r\n\r\n - Women who are pregnant or lactating.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** RP6530\n- **Description:** Tablet starting at 200 mg\n- **Mesh Terms:** Tenalisib\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02875080
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEvaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects\n\n**Trial Summary:** \n\n\n The ratios of the geometric means of the ODT formulation to those of the reference\r\n formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of\r\n brexpiprazole (OPC-34712)).\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy Adult Male\n\n**Condition Keywords:** None\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 20 Years\n- **Maximum Age:** 45 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Capable of providing written informed consent prior to initiation of any trial-related\r\n procedures, and able, in the opinion of the investigator, to comply with all\r\n requirements of the trial\r\n\r\n Exclusion Criteria:\r\n\r\n - Clinically significant abnormality at the time of screening (eg, significant deviation\r\n from reference ranges) or in medical history that, in the opinion of investigator or\r\n sponsor may place the subject at risk or interfere with outcome variables, including\r\n drug absorption, distribution, metabolism, and excretion\r\n\r\n - History of serious mental disorder\r\n\r\n - History of drug or alcohol abuse within 2 years prior to screening\r\n\r\n - History of any significant drug allergy\r\n\r\n - Use of an investigational drug within 120 days prior to the first dosing of trial drug\r\n\r\n - Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to\r\n screening\r\n\r\n - Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange\r\n products, starfruit, or starfruit products within 72 hours prior to dosing\r\n\r\n - Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or\r\n St. John's Wort within 14 days prior to the first dosing of trial drug, or of\r\n antibiotics within 30 days prior to the first dosing of trial drug\r\n\r\n - History of major surgery of the digestive tract (excluding appendectomy)\r\n\r\n - Any subject who, in the opinion of the investigator, should not participate in the\r\n trial\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** OPC-34712\n- **Description:** None\n- **Mesh Terms:** Brexpiprazole\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04316104
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nCuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos\n\n**Trial Summary:** \n\n\n Latino families with dementia experience substantial disparities in access to caregiver\r\n support compared to their non-Latino white peers, putting them at an increased risk for\r\n negative emotional, physical and financial outcomes. This R21 will address this research gap\r\n by 1) Developing a culturally and linguistically appropriate text message intervention for\r\n caregiver support among Latino family caregivers of individuals with dementia and 2) Testing\r\n the feasibility and acceptability of CuidaTXT, a multicomponent text message caregiver\r\n support intervention culturally and linguistically tailored for the Latino community.\r\n \n\n**Trial Keywords:** ['Dementia', 'Caregiver', 'mHealth', 'Stress', 'Latino', 'Disparities']\n\n**Phase:** Phase 1\n\n**Condition:** Caregiver Burnout\n\n**Condition Keywords:** ['Dementia', 'Caregiver Burden']\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Spanish and English-speaking individuals\r\n\r\n - Over the age of 18\r\n\r\n - Identify as Latino\r\n\r\n - Report providing hands-on care for a relative who has been given a clinical or\r\n research dementia diagnosis\r\n\r\n - Care recipient has an AD-8 screening score greater than or equal to 2, indicating\r\n cognitive impairment\r\n\r\n - Self-report being able to read and write\r\n\r\n - Self-report owning a cell phone with a flat fee and use it at least weekly for texting\r\n\r\n Exclusion Criteria:\r\n\r\n -\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** CuidaTXT\n- **Description:** Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT05233085
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Safety Study of AZD4041 in Healthy Participants\n\n**Trial Summary:** \n\n\n This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, multiple\r\n ascending doses (MAD) study in healthy male and female adult participants.\r\n\r\n The study will include up to 48 participants (12 participants per cohort) who will be\r\n randomized 9:3 to active drug or placebo. Each cohort will receive AZD4041 or placebo in a\r\n MAD study.\r\n\r\n A sequential cohort MAD design will be employed to assure that higher doses are administered\r\n to healthy participants only after lower doses have demonstrated an acceptable safety\r\n profile.\r\n\r\n The total study duration will be up to 59 days (including Screening) per participant.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Opioid Use Disorder (OUD)\n\n**Condition Keywords:** Opioid-Related Disorders\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion Criteria\r\n\r\n - Provision of signed and dated written informed consent form prior to any study\r\n specific procedures\r\n\r\n - Stated willingness to comply with all study procedures and availability for the\r\n duration of the study\r\n\r\n - Healthy adult male or female participants. Female participants must be of\r\n non-childbearing potential (postmenopausal and/or surgically sterile)\r\n\r\n - If female, meets one of the following criteria:\r\n\r\n 1. Physiological postmenopausal status, defined as the following:\r\n\r\n 1. absence of menses for at least 12 months following cessation of all\r\n exogenous hormonal treatments (without an alternative medical condition) at\r\n Screening and prior to the first study drug administration; and\r\n\r\n 2. follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening; and\r\n\r\n 3. must have a negative pregnancy test result at screening and check-in. and/or\r\n\r\n 2. Surgical sterile, defined as those who have had:\r\n\r\n hysterectomy, bilateral oophorectomy and/or bilateral salpingectomy, or bilateral tubal\r\n ligation. Women who are surgically sterile must provide documentation of the procedure by\r\n an operative report, ultrasound, or other verifiable documentation; and must have a\r\n negative pregnancy test result at screening and check-in.\r\n\r\n If postmenopausal and has an FSH of < 40 mIU/mL, but meets all other criteria in (1) or (2)\r\n above as well as all the other inclusion criteria, screening oestradiol serum level must be\r\n equal to or below 150 pmol/L.\r\n\r\n - Men who are biologically capable of fathering children must agree and commit to use an\r\n adequate form of contraception for the duration of the treatment period and for no\r\n less than 120 days (4 months) after the last administration of study intervention. A\r\n male participant is considered capable of fathering children even if his sexual\r\n partner is sterile or using contraceptives.\r\n\r\n - Men who are biologically capable of fathering children must also agree to refrain from\r\n sperm donation for the duration of the treatment period and for at least 90 days after\r\n the last administration of study intervention.\r\n\r\n - Aged at least 18 years but not older than 55 years on the day of randomization\r\n\r\n - Body mass index (BMI) within 18.0 kg/m^2 to 30.0 kg/m^2, inclusive\r\n\r\n - Body weight of within 50 kg to 100 kg, inclusive\r\n\r\n - Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using\r\n nicotine products for at least 180 days prior to the first study drug administration)\r\n\r\n - Have no clinically significant diseases captured in the medical history or evidence of\r\n clinically significant findings on the physical or neurological examination (including\r\n vital signs) and/or ECG and/or safety laboratory tests, as determined by an\r\n Investigator\r\n\r\n - Suitable veins for cannulation or repeated venepuncture\r\n\r\n Exclusion Criteria\r\n\r\n - Female who is lactating\r\n\r\n - Female who is pregnant according to the pregnancy test at Screening or prior to the\r\n first study drug administration\r\n\r\n - Male participants with a history of oligospermia or azoospermia or any other disorder\r\n of the reproductive system\r\n\r\n - Male participants who are undergoing treatment or evaluation for infertility.\r\n\r\n - History of significant allergy/ hypersensitivity to AZD4041 or products related to\r\n AZD4041 as well as severe allergy/hypersensitivity reactions (like angioedema) to any\r\n drugs\r\n\r\n - Presence or history of significant gastrointestinal, liver or kidney disease, or any\r\n other condition that is known to interfere with drug absorption, distribution,\r\n metabolism, or excretion, or known to potentiate or predispose to undesired effects\r\n\r\n - History of any significant disease, including [but not necessarily limited to]\r\n significant cardiovascular, pulmonary, hematologic, neurological, psychiatric,\r\n endocrine, immunologic, or dermatologic disease\r\n\r\n - Maintenance therapy with any drug or significant history of drug dependency or alcohol\r\n abuse (> 21 units/week or > 3 units/day for men; > 14 units/week or > 2 units/day for\r\n women; intake of excessive alcohol, acute or chronic)\r\n\r\n - History of any significant psychiatric disorder according to the criteria of the\r\n Diagnostic and Statistical manual of Mental Disorders, 5th Edition (DSM-5, American\r\n Psychiatric Association 2013) which, in the opinion of the Investigator, could be\r\n detrimental to participant safety or could compromise study data interpretation.\r\n\r\n - History of substance use disorder, other than nicotine or caffeine (as per DSM-5\r\n criteria)\r\n\r\n - Use of any prescription drugs, including hormone replacement therapy in the 28 days\r\n prior to the first study drug administration, that in the opinion of an Investigator\r\n would put into question the status of the participant as healthy\r\n\r\n - Use of St. John's wort in the 28 days prior to the first study drug administration\r\n\r\n - Positive test result for alcohol and/or drugs of abuse at Screening or prior to the\r\n first study drug administration\r\n\r\n - Any clinically significant illness, medical/surgical procedure or trauma within the 28\r\n days prior to the first study drug administration\r\n\r\n - Any abnormal or clinically significant findings in laboratory test results at\r\n Screening that would, in the opinion of an Investigator, increase the participant's\r\n risk of participation, jeopardize complete participation in the study, or compromise\r\n interpretation of study data\r\n\r\n - Positive screening results to human immunodeficiency virus (HIV) antigen/antibody\r\n (Ag/Ab) combo, hepatitis B surface antigen, or hepatitis C virus tests\r\n\r\n - Showing suicidal tendency as per the C-SSRS questionnaire administered at Screening\r\n\r\n - Any abnormal vital signs, after 10 minutes supine rest, as defined in the list below,\r\n at the Screening Visit/or Day -2 Out of range tests may be repeated once for each\r\n visit at the discretion of an Investigator.\r\n\r\n 1. Systolic blood pressure (BP) < 90 mmHg or >140 mmHg\r\n\r\n 2. Diastolic BP < 50 mmHg or > 90 mmHg\r\n\r\n 3. Heart Rate < 45 or > 85 beats per minute (bpm)\r\n\r\n - Any clinically important abnormalities in rhythm, conduction, or morphology of the\r\n resting ECG and any clinically important abnormalities in the 12-lead ECG which, in an\r\n Investigator's opinion, may interfere with the interpretation of QTc interval changes,\r\n including abnormal ST-T-wave morphology, particularly in the protocol-defined primary\r\n lead or left ventricular hypertrophy at Screening or prior to the first study drug\r\n administration\r\n\r\n - Prolonged QT interval corrected for HR using Fridericia's formula (QTcF) > 440 ms at\r\n Screening or prior to the first study drug administration\r\n\r\n - Shortened QTcF < 340 ms at Screening or prior to first study drug administration\r\n\r\n - Known family history of long QT syndrome\r\n\r\n - ECG interval measured from the onset of the P wave to the onset of the complex between\r\n Q and S waves (QRS complex) (PR [PQ]) interval shortening < 120 ms (PR > 110 ms but <\r\n 120 ms is acceptable if there is no evidence of ventricular preexcitation) at\r\n Screening or prior to the first study drug administration\r\n\r\n - PR (PQ) interval prolongation (> 220 ms), persistent or intermittent second\r\n (Wenckebach block while asleep is not exclusive), or third degree atrioventricular\r\n (AV) block, or AV dissociation at Screening or prior to the first study drug\r\n administration\r\n\r\n - Persistent or intermittent complete bundle branch block, incomplete bundle branch\r\n block, or intraventricular conduction delay (IVCD) with ECG interval measured from the\r\n onset of the QRS complex to the J point (QRS) > 110 ms. Participants with QRS > 110 ms\r\n but < 115 ms are acceptable if there is no evidence of ventricular hypertrophy or\r\n preexcitation at Screening or prior to the first study drug administration\r\n\r\n - In the pre-dose 24 hour telemetry, presence of ≥ 10 ventricular premature contractions\r\n (VPCs) during 1 hour, or ≥ 100 VPCs during 24-hours of telemetry, or any occurrence of\r\n paired VPC (ventricular couplets) or other repetitive ventricular rhythms, including\r\n non-sustained or sustained (> 30 second duration), slow (< 100 bpm), or fast (≥ 100\r\n bpm) ventricular tachycardias.\r\n\r\n - Vaccination with the Coronavirus disease 2019 (COVID-19) vaccine less than 14 days\r\n prior to first study dose administration\r\n\r\n - Scheduled immunization with a COVID-19 vaccine (first or second dose) during the study\r\n that, in the opinion of an Investigator, could potentially interfere with participant\r\n participation, participant safety, study results, or any other reason\r\n\r\n - Use of any prescribed or nonprescribed oral and topical inhibitors/inducers of CYP3A4\r\n (including shampoo).\r\n\r\n - Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as\r\n judged by an Investigator\r\n\r\n - Participants who have previously received AZD4041\r\n\r\n - Any history of tuberculosis\r\n\r\n - Involvement of any AstraZeneca or study site employee or their close relatives\r\n\r\n - Judgment by an Investigator that the participant should not participate in the study\r\n if they have any ongoing or recent (ie, during the Screening period) minor medical\r\n complaints that may interfere with the interpretation of study data or are considered\r\n unlikely to comply with study procedures, restrictions, and requirements\r\n\r\n - Presence of any tongue piercings or history of any tongue piercings in the last 90\r\n days prior to the first study drug administration\r\n\r\n - Participants who have medical dietary restrictions\r\n\r\n - Participants who cannot communicate reliably with the Investigator\r\n\r\n - Inclusion in a previous group for this clinical study\r\n\r\n - Intake of an investigational product (IP) within at least 28 days or 5 half-lives;\r\n whichever is longer, prior to the first study drug administration\r\n\r\n - Donation of 50 mL or more of blood in the 28 days prior to the first study drug\r\n administration\r\n\r\n - Donation of 500 mL or more of blood in the 56 days prior to the first study drug\r\n administration\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['AZD4041', 'Placebo']\n- **Description:** ['Participants will receive oral solution of AZD4041 as stated in arm description.', 'Participants will receive oral solution of placebo as stated in arm description.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03482024
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function\n\n**Trial Summary:** \n\n\n The purpose of this study is to assess how fast tirzepatide gets into the blood stream and\r\n how long it takes the body to remove it in participants with impaired kidney function\r\n compared to healthy participants.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Renal Insufficiency', 'End Stage Renal Disease']\n\n**Condition Keywords:** ['Kidney Failure, Chronic', 'Renal Insufficiency']\n\n**ICD Code:** [\"['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']\", \"['N18.6', 'I12.0', 'I13.11', 'I13.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 85 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - All Participants:\r\n\r\n - Women not of childbearing potential may participate and include those who are\r\n infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or\r\n tubal ligation), congenital anomaly such as mullerian agenesis; or postmenopausal\r\n\r\n - Are between the body mass index (BMI) of 19.0 and 40.0 kilograms per meter\r\n squared (kg/m²), inclusive, at screening\r\n\r\n - Healthy Participants:\r\n\r\n -- Healthy males or females as determined by medical history, physical examination,\r\n and other screening procedures, with normal renal function, assessed by estimated\r\n glomerular filtration rate (eGFR) ≥90 milliliters per minute (mL/min) at screening\r\n\r\n - Participants with Renal Impairment or ESRD:\r\n\r\n -- Males or females with stable mild to severe renal impairment, assessed by eGFR or\r\n with ESRD (having received hemodialysis for at least 3 months)\r\n\r\n - Participants with Type 2 Diabetes Mellitus (T2DM) and Renal Impairment or ESRD:\r\n\r\n - Have T2DM controlled with diet or exercise alone or stable on metformin for at\r\n least 8 weeks\r\n\r\n - Taking stable doses of over-the-counter or prescription medications (eg,\r\n antihypertensive agents, aspirin, lipid-lowering agents) for treatment of\r\n concurrent medical conditions are permitted to participate providing they have\r\n been stable on their treatment regimen for at least 4 weeks\r\n\r\n - Have a hemoglobin A1c (HbA1c) ≥7.0% and ≤11.0% at screening\r\n\r\n Exclusion Criteria:\r\n\r\n - All Participants:\r\n\r\n - Women of childbearing potential\r\n\r\n - Have known allergies to tirzepatide or related compounds\r\n\r\n - Have a personal or family history of medullary thyroid carcinoma or have multiple\r\n endocrine neoplasia syndrome type 2\r\n\r\n - Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2×\r\n the upper limit of normal (ULN) or total bilirubin (TBL) >1.5× ULN\r\n\r\n - Have a history or presence of pancreatitis (history of chronic pancreatitis or\r\n idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI\r\n disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI\r\n disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric\r\n stenosis, with the exception of appendectomy) or could be aggravated by\r\n glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV)\r\n inhibitors\r\n\r\n - Participants with Renal Impairment or ESRD:\r\n\r\n - Have hemoglobin <8.5 grams per deciliter (g/dL) or significant active\r\n hematological disease from causes other than underlying renal disease.\r\n\r\n - Have used any drug indicated for medical care of the participant's renal\r\n impairment, which is not established in dose and administered for at least 7 days\r\n before LY3298176 administration\r\n\r\n - Participants with T2DM and Renal Impairment or ESRD:\r\n\r\n - Have taken any glucose-lowering medications other than metformin, including\r\n insulin, in the past 3 months before screening\r\n\r\n - Have had more than 1 episode of severe hypoglycemia, as defined by the American\r\n Diabetes Association criteria, within 6 months before entry into the study or has\r\n a history of hypoglycemia unawareness or poor recognition of hypoglycemic\r\n symptoms\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Tirzepatide\n- **Description:** Administered SC.\n- **Mesh Terms:** Tirzepatide\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04235959
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus\n\n**Trial Summary:** \n\n\n The main purpose of this study is to learn more about the safety and side effects of\r\n tirzepatide in Chinese participants with type 2 diabetes mellitus. The study will also\r\n measure how much tirzepatide gets into the bloodstream and how long it takes the body to\r\n remove it. The study will last about six or eight months for each participant.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Diabetes Mellitus, Type 2\n\n**Condition Keywords:** ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2']\n\n**ICD Code:** [\"['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 20 Years\n- **Maximum Age:** 70 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are\r\n stable on a single oral antihyperglycemic medication (OAM), metformin, acarbose, or\r\n sulphonylureas only (other types of OAM [dipeptidyl peptidase IV inhibitors,\r\n sodium-glucose cotransporter-2 inhibitors, and thiazolidinediones] are not allowed in\r\n this study), for at least 3 months\r\n\r\n - Have a body mass greater than or equal to (≥)23 kilograms per square meter (kg/m²),\r\n inclusive\r\n\r\n Exclusion Criteria:\r\n\r\n - Have type 1 diabetes mellitus\r\n\r\n - Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6\r\n months prior to Visit 1\r\n\r\n - Have a history of heart block or PR interval greater than (>)220 milliseconds (msec)\r\n or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the\r\n opinion of the investigator, increases the risks associated with participating in the\r\n study\r\n\r\n - Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or a GI\r\n disease that impacts gastric emptying or could be aggravated by glucagon-like\r\n peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors\r\n\r\n - Have known allergies to tirzepatide, GLP-1 analogs, or related compounds or any\r\n components of the formulation\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Tirzepatide', 'Placebo']\n- **Description:** ['Administered SC', 'Administered SC']\n- **Mesh Terms:** Tirzepatide\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT04542291
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nTargeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition\n\n**Trial Summary:** \n\n\n This is a first-in-human, pilot study of the feasibility and safety of dapagliflozin (in\r\n addition to standard of care treatment) for the treatment of patients with metastatic\r\n pancreatic ductal adenocarcinoma. The primary hypothesis is that dapagliflozin is\r\n well-tolerated and safe to use in this patient population. The investigators also hypothesize\r\n that dapagliflozin will be efficacious as an adjunct to front-line chemotherapy assessed by\r\n decreased tumor markers mediated by its pleiotropic metabolic effects.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Pancreas Cancer', 'Pancreatic Cancer', 'Cancer of the Pancreas']\n\n**Condition Keywords:** Pancreatic Neoplasms\n\n**ICD Code:** [\"['D13.6', 'C25.4', 'C25.9', 'D13.7', 'C25.0', 'C25.1', 'C25.2']\", \"['C25.3']\", \"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Histologically or cytologically confirmed metastatic or locally advanced pancreatic\r\n ductal adenocarcinoma, pancreatic adenosquamous carcinoma or squamous cell carcinoma\r\n\r\n - Patients with treated/stable brain metastases, defined as patients who have received\r\n prior therapy for their brain metastases and whose CNS disease is radiographically\r\n stable at study entry, are eligible.\r\n\r\n - Measurable disease defined as lesions that can be accurately measured in at least one\r\n dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by\r\n chest x-ray, or ≥ 10 mm with calipers by clinical exam.\r\n\r\n - No prior systemic therapy for pancreatic ductal adenocarcinoma in the metastatic or\r\n locally advanced setting.\r\n\r\n - Planning to receive treatment with nab-paclitaxel and gemcitabine.\r\n\r\n - At least 18 years of age.\r\n\r\n - ECOG performance status ≤ 1\r\n\r\n - Normal bone marrow and organ function as defined below:\r\n\r\n - Leukocytes ≥ 3,000/mcL\r\n\r\n - Absolute neutrophil count ≥ 1,500/mcL\r\n\r\n - Platelets ≥ 100,000/mcL\r\n\r\n - Total bilirubin ≤ 1.5 x IULN\r\n\r\n - AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN\r\n\r\n - Estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m^2\r\n\r\n - Because chemotherapeutic agents such as nab-paclitaxel and gemcitabine are known to be\r\n teratogenic, women of childbearing potential and men must agree to use adequate\r\n contraception (hormonal or barrier method of birth control, abstinence) prior to study\r\n entry and for the duration of study participation. Should a woman become pregnant or\r\n suspect she is pregnant while participating in this study, she must inform her\r\n treating physician immediately. Men treated or enrolled on this protocol must also\r\n agree to use adequate contraception prior to the study, for the duration of the study,\r\n and at least one month after completion of the study\r\n\r\n - Agreement to adhere to Lifestyle Considerations throughout study duration\r\n\r\n - Ability to understand and willingness to sign an IRB approved written informed consent\r\n document (or that of legally authorized representative, if applicable).\r\n\r\n Exclusion Criteria:\r\n\r\n - History of total pancreatectomy\r\n\r\n - Current or previous treatment with SGLT2i or thiazolidinedione.\r\n\r\n - Currently receiving regularly scheduled systemic steroids in the form of prednisone or\r\n dexamethasone. Note that dexamethasone that can be prescribed for nausea on the day of\r\n chemotherapy, but in subsequent days will be replaced by a nonsteroidal anti-emetic\r\n for patients in this trial. Topical steroid ointments or creams for occasional skin\r\n rash is allowed.\r\n\r\n - A history of other malignancy with the exceptions of malignancies for which all\r\n treatment was completed at least 2 years before registration with no evidence of\r\n disease and locally treated skin squamous or basal cell carcinoma.\r\n\r\n - History of stroke or transient ischemic attack (in the last 5 years).\r\n\r\n - HbA1c > 10% unless approved by endocrinologist\r\n\r\n - Currently receiving any other investigational agents.\r\n\r\n - A history of allergic reactions attributed to compounds of similar chemical or\r\n biologic composition to dapagliflozin, nab-paclitaxel, gemcitabine or other agents\r\n used in the study.\r\n\r\n - Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease\r\n (estimated glomerular filtration rate eGFR < 30 mL/min/1.73m2), symptomatic\r\n hypotension, and chronic/frequent urinary tract infections or yeast infections.\r\n\r\n - Pregnant and/or breastfeeding. Women of childbearing potential must have a negative\r\n pregnancy test within 14 days of study entry.\r\n\r\n - Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or\r\n they have a history of AIDS-defining opportunistic infection within the 12 months\r\n prior to registration. Concurrent treatment with effective ART according to DHHS\r\n treatment guidelines is recommended.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Dapagliflozin', 'BIOSENSE meters']\n- **Description:** ['Dapagliflozin will be provided for this trial', '-Being used in this trial to evaluate utility for assessing breath ketones']\n- **Mesh Terms:** Dapagliflozin\nSMILES: ['CCOC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)C=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT04497948
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nAcalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19\n\n**Trial Summary:** \n\n\n Study D822FC00005 will investigate the Phamacokinetics, Safety and tolerability of\r\n Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a\r\n Proton Pump Inhibitor, in the treatment of COVID-19.\r\n \n\n**Trial Keywords:** ['2019 novel coronavirus disease', 'Acalabrutinib', 'Btk inhibitor']\n\n**Phase:** Phase 1\n\n**Condition:** COVID-19\n\n**Condition Keywords:** COVID-19\n\n**ICD Code:** [\"['U07.1', 'Z28.310', 'Z28.311', 'Z86.16', 'U09.9', 'Z11.52', 'Z20.822']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 100 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Participant or legally authorized representative must be able to understand the\r\n purpose and risks of the study and provide written informed consent and authorization\r\n to use protected health information (in accordance with national and local patient\r\n privacy regulations).\r\n\r\n 2. Participants who are hospitalized with coronavirus (SARS-CoV-2) infection, confirmed\r\n by PCR test or other commercial or public health assay in any specimen, as documented\r\n by either of the following:\r\n\r\n 1. PCR positive in sample collected < 72 hours prior to first dose, OR\r\n\r\n 2. PCR positive in sample collected ≥ 72 hours prior to first dose (but no more than\r\n 14 days prior to first dose), documented inability to obtain a repeat sample (eg,\r\n due to lack of testing supplies, limited testing capacity, results taking > 24\r\n hours, etc), AND progressive disease suggestive of ongoing SARS-CoV-2 infection 3\r\n Evidence of respiratory failure attributable to COVID-19 pneumonia (documented\r\n radiographically) before enrollment 4 Nasogastric tube or other types of oral or\r\n percutaneous gastric feeding tube; placement must be radiographically confirmed\r\n and expected to remain in place, as judged by the investigator, for a minimum of\r\n 3 days after study enrolment.\r\n\r\n 5 Has received treatment with PPIs (eg, omeprazole, esomeprazole, lansoprazole,\r\n dexlansoprazole, rabeprazole, or pantoprazole) for a minimum of 24 hours\r\n immediately prior to enrollment; any PPI will be permitted, provided it meets the\r\n minimum equivalent daily dose of 20 mg rabeprazole.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Any serious and uncorrectable medical condition or abnormality of clinical\r\n laboratory tests that, in the Investigator's judgment, precludes the\r\n participant's safe participation in and completion of the study.\r\n\r\n 2. In the opinion of the Investigator, progression to death is imminent and\r\n inevitable within the next 24 hours, irrespective of the provision of\r\n treatments.\r\n\r\n 3. Current refractory nausea and vomiting, malabsorption syndrome, disease\r\n significantly affecting gastrointestinal function, resection of the stomach,\r\n extensive small bowel resection that is likely to affect absorption,\r\n symptomatic inflammatory bowel disease, partial or complete bowel\r\n obstruction, or gastric restrictions and bariatric surgery, such as gastric\r\n bypass.\r\n\r\n 4. Received BTK inhibitor within 7 days before enrollment.\r\n\r\n 5. Requires or is receiving anticoagulation with warfarin or equivalent vitamin\r\n K antagonists (eg, phenprocoumon) within 7 days prior to enrollment. Other\r\n anticoagulants are permitted.\r\n\r\n 6. Participants on dual antiplatelet and therapeutic anticoagulant therapy (eg,\r\n aspirin and therapeutic doses of low molecular weight heparin are not\r\n allowed; however, aspirin and prophylactic/ low doses of\r\n low-molecular-weight heprin are allowed).\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Acalabrutinib\n- **Description:** Acalabrutinib (CALQUENCE®) is a covalent BTK inhibitor\n- **Mesh Terms:** Acalabrutinib\nSMILES: ['CC#CC(=O)N1CCC[C@H]1C1=NC(=C2N1C=CN=C2N)C1=CC=C(C=C1)C(=O)NC1=CC=CC=N1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02171260
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nThis is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas\n\n**Trial Summary:** \n\n\n This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or\r\n refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be\r\n administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims\r\n to determine the maximum tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of\r\n this regimen in Part A1 (participants greater than or equal to [>=] 12 months and less than\r\n [<] 18 years). Part A2 will enroll infants (greater than [>] 6 months and <12 months) one\r\n dose level behind the dose level at which participants in Part A1 are enrolling, in order to\r\n maximize safety for infant participants. Additionally, this study aims to describe the\r\n toxicities and the pharmacokinetics of eribulin mesylate when administered to children. In a\r\n preliminary manner, the antitumor effect of eribulin mesylate will also be described.\r\n \n\n**Trial Keywords:** ['Tumors', 'Lymphomas', 'Solid Tumors', 'Pediatric']\n\n**Phase:** Phase 1\n\n**Condition:** ['Pediatrics', 'Solid Tumors']\n\n**Condition Keywords:** Lymphoma\n\n**ICD Code:** ['None', 'None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 6 Months\n- **Maximum Age:** 17 Years\n- **Criteria:** \n Inclusion Criteria\r\n\r\n - Participants must be >=12 months and <18 years of age at the time of study enrollment\r\n (Part A1).\r\n\r\n - Participants must be >6 months and <12 months of age at the time of study enrollment\r\n (Part A2). Participants will enroll one dose level behind the dose level at which\r\n participants in Part A1 are enrolling.\r\n\r\n - Participants with refractory or recurrent solid tumors or lymphomas, excluding CNS\r\n tumors, are eligible. Participants must have had histologic verification of malignancy\r\n at original diagnosis or relapse. Participants with primary CNS tumors, known CNS\r\n metastases, or a prior history of CNS metastases are not eligible.\r\n\r\n - Participants must have either measurable or evaluable disease.\r\n\r\n - Participants current disease state must be one for which there is no known curative\r\n therapy or therapy proven to prolong survival with an acceptable quality of life.\r\n\r\n - Karnofsky >= 50% for participants >16 years of age and Lansky >=50 for participants\r\n less than or equal to (<=)16 years of age. Participants who are unable to walk because\r\n of paralysis, but who are up in a wheelchair, will be considered ambulatory for the\r\n purpose of assessing the performance score.\r\n\r\n - Participants must have fully recovered from the acute toxic effects of all prior\r\n anticancer chemotherapy.\r\n\r\n 1. Myelosuppressive chemotherapy: At least 21 days after the last dose of\r\n myelosuppressive chemotherapy (42 days if prior nitrosourea).\r\n\r\n 2. Hematopoietic growth factors: At least 14 days after the last dose of a\r\n long-acting growth factor (example Neulasta) or 7 days for short-acting growth\r\n factor. For agents that have known adverse events occurring beyond 7 days after\r\n administration, this period must be extended beyond the time during which adverse\r\n events are known to occur. The duration of this interval must be discussed with\r\n the study chair.\r\n\r\n 3. Biologic (anti-neoplastic agent): At least 14 days after the last dose of a\r\n biologic agent. For agents that have known adverse events occurring beyond 14\r\n days after administration, this period must be extended beyond the time during\r\n which adverse events are known to occur. The duration of this interval must be\r\n discussed with the study chair.\r\n\r\n 4. Immunotherapy: At least 42 days after the completion of any type of\r\n immunotherapy, example tumor vaccines.\r\n\r\n 5. Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose\r\n of a monoclonal antibody.\r\n\r\n 6. X-ray telescope (XRT): At least 14 days after local palliative XRT (small port);\r\n At least 150 days must have elapsed if prior total body irradiation(TBI),\r\n craniospinal and/or entire spinal XRT or if >=50% radiation of pelvis; At least\r\n 42 days must have elapsed if other substantial bone marrow (BM) radiation.\r\n\r\n 7. Stem Cell Infusion without TBI: No evidence of active graft versus host disease\r\n and at least 84 days must have elapsed after transplant or stem cell infusion.\r\n\r\n - Adequate Bone Marrow Function Defined as:\r\n\r\n 1. Peripheral absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm^3).\r\n\r\n 2. Platelet count >=100,000/mm^3 (transfusion independent, defined as not receiving\r\n platelet transfusions for at least 7 days prior to enrollment).\r\n\r\n 3. Hemoglobin (Hb) at least 8 gram per deciliter (g/dL) at baseline (blood\r\n transfusions are allowed during the screening period to correct Hb values less\r\n than 8 g/dL).\r\n\r\n All participants enrolled on the study must be evaluable for hematologic toxicity.\r\n\r\n - Adequate Renal Function Defined as:\r\n\r\n 1. Creatinine clearance or radioisotope glomerular filtration rate (GFR) >=70\r\n milliliter per minute (ml/min) per (/) 1.73 square meter (m^2) or\r\n\r\n 2. A serum creatinine milligram per deciliter (mg/dL) based on age/gender as\r\n follows:\r\n\r\n 1. 6 months to <1 year: male, 0.5; female, 0.5\r\n\r\n 2. 1 to < 2 years: male, 0.6; female, 0.6\r\n\r\n 3. 2 to < 6 years: male, 0.8; female, 0.8\r\n\r\n 4. 6 to < 10 years: male, 1; female, 1\r\n\r\n 5. 10 to < 13 years: male, 1.2; female, 1.2\r\n\r\n 6. 13 to < 16 years: male, 1.5; female, 1.4\r\n\r\n 7. >=16 years: male, 1.7; female, 1.4\r\n\r\n The threshold creatinine values were derived from the Schwartz formula for\r\n estimating GFR (Schwartz et al., 1985) utilizing child length and stature\r\n data published by the Centers for Disease Control and Prevention (CDC).\r\n\r\n - Adequate Liver Function Defined as:\r\n\r\n 1. Bilirubin (sum of conjugated + unconjugated) <=1.5 * upper limit of normal (ULN)\r\n for age\r\n\r\n 2. serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase [ALT]) <=110\r\n units per liter (U/L). For the purpose of this study, the ULN for SGPT is 45 U/L.\r\n\r\n 3. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])\r\n <= 125 U/L. For the purpose of this study, the ULN for SGOT is 50 U/L.\r\n\r\n 4. Serum albumin >= 2 g/dL\r\n\r\n - Adequate Cardiac Function Defined as:\r\n\r\n 1. Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50%\r\n by gated radionuclide study\r\n\r\n 2. Corrected QT interval (QTc) <= 480 millisecond (msec) Note: Participants with\r\n Grade 1 prolonged QTc (450-480 msec) at the time of study enrollment should have\r\n correctable causes of prolonged QTc addressed if possible (that is, electrolytes,\r\n medications).\r\n\r\n - All participants and/or their participants or legally authorized representatives must\r\n sign a written informed consent. Assent, when appropriate, will be obtained according\r\n to institutional guidelines. Participants must be willing to comply with all aspects\r\n of the protocol.\r\n\r\n - Participants with known human immunodeficiency virus (HIV) who have CD4+ T cell counts\r\n greater than or equal to 500 cells/m^3 and who do not require antiretroviral therapy\r\n are eligible.\r\n\r\n Exclusion Criteria\r\n\r\n - Pregnant or breast-feeding women will not be entered on this study due to risks of\r\n fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must\r\n be obtained in girls who are post-menarchal. Males or females of reproductive\r\n potential may not participate unless they have agreed to use an effective double\r\n barrier contraceptive method for the entire period in which they are receiving\r\n protocol therapy and up to 6 months after treatment.\r\n\r\n - Concomitant Medications\r\n\r\n - Participants receiving corticosteroids who have not been on a stable or\r\n decreasing dose of corticosteroid for at least 7 days prior to enrollment are not\r\n eligible.\r\n\r\n - Participants who are currently receiving another investigational drug are not\r\n eligible.\r\n\r\n - Participants who are currently receiving other anticancer agents are not\r\n eligible.\r\n\r\n - Participants who are receiving cyclosporine, tacrolimus or other agents to\r\n prevent graft-versus-host disease post bone marrow transplant are not eligible\r\n for this trial.\r\n\r\n - Participants who are receiving drugs that prolong the QTc are not eligible.\r\n\r\n - Participants who have received prior therapy with eribulin mesylate are not eligible.\r\n\r\n - Participants with hypersensitivity to excipients of the study drug are not eligible.\r\n The excipients are ethanol, hydrochloric acid, sodium hydroxide and water for\r\n injection.\r\n\r\n - Participants who have a prior history of viral hepatitis (B or C) as demonstrated by\r\n positive serology (presence of antigens) or have an uncontrolled infection requiring\r\n treatment are not eligible.\r\n\r\n - Participants with greater than Grade 1 peripheral sensory neuropathy or greater than\r\n Grade 1 peripheral motor neuropathy graded according to the Modified (\"Balis\")\r\n Pediatric Scale of Peripheral Neuropathies are not eligible.\r\n\r\n - Cardiac Pathology\r\n\r\n - Participants with known congestive heart failure, symptomatic or left ventricle\r\n (LV) ejection fraction 50% or shortening fraction less than 27% are not eligible.\r\n\r\n - Participants with congenital long QT syndrome, bradyarrhythmias, or QTc greater\r\n than 480 msec are not eligible.\r\n\r\n - CNS Disease\r\n\r\n - Participants with primary CNS tumors are not eligible.\r\n\r\n - Participants with prior history of or known metastatic CNS disease involvement\r\n are not eligible. (Note: CNS imaging for participants without a known history of\r\n CNS disease is only required if clinically indicated).\r\n\r\n - Participants who have had or are planning to have the following invasive procedures\r\n are not eligible:\r\n\r\n - Major surgical procedure, laparoscopic procedure, open biopsy or significant\r\n traumatic injury within 28 days prior to enrollment.\r\n\r\n - Central line placement or subcutaneous port placement is not considered major\r\n surgery but must be placed at least 3 days prior to enrollment for external lines\r\n (with example, Hickman or Broviac) and at least 7 days prior to enrollment for\r\n subcutaneous port.\r\n\r\n - Core biopsy within 7 days prior to enrollment.\r\n\r\n - Fine needle aspirate within 7 days prior to enrollment. NOTE: For purposes of\r\n this study, bone marrow aspirate and biopsy are not considered surgical\r\n procedures and therefore are permitted within 14 days prior to start of protocol\r\n therapy.\r\n\r\n - Participants with known bone marrow involvement are not eligible.\r\n\r\n - Participants who have received a prior solid organ transplantation are not eligible.\r\n\r\n - Participants who in the opinion of the investigator may not be able to comply with the\r\n safety monitoring requirements of the study are not eligible.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Eribulin Mesylate\n- **Description:** Eribulin mesylate will be administered intravenously on Days 1 and 8 of each 21-day cycle.\n- **Mesh Terms:** None\nSMILES: ['[H][C@@]12CC(=C)[C@]([H])(CC[C@@]3([H])C[C@@H](C)C(=C)[C@@]([H])(C[C@]4([H])O[C@H](C[C@H](O)CN)[C@H](OC)[C@@]4([H])CC(=O)C[C@@]4([H])CC[C@]5([H])O[C@@]6([H])[C@H]7O[C@@]8(C[C@]7([H])O[C@@]6([H])[C@@]([H])(O8)[C@@]5([H])O4)CC1)O3)O2']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03102190
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nTrial of Topical Verapamil in Chronic Rhinosinusitis With Nasal Polyps\n\n**Trial Summary:** \n\n\n Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce\r\n inflammation in a variety of tissues. Chronic rhinosinusitis with nasal polyps (CRSwNP) is\r\n characterized by eosinophilic inflammation as well as P-gp overexpression. A previous trial\r\n of oral Verapamil showed preliminary efficacy for the treatment of CRSwNP. The goal of this\r\n study is to evaluate the safety and efficacy of intranasal Verapamil in CRSwNP. The study was\r\n initially approved as a Phase Ib/II, but only the Phase Ib portion was completed as part of\r\n this protocol.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Sinusitis', 'Nasal Polyps']\n\n**Condition Keywords:** ['Sinusitis', 'Nasal Polyps', 'Polyps']\n\n**ICD Code:** [\"['J01.80', 'J01.90', 'J32.0', 'J32.1', 'J32.2', 'J32.3', 'J32.8']\", 'None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 80 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Patients presenting to the Mass Eye and Ear Sinus Center\r\n\r\n - Age 18-80 yrs old\r\n\r\n - Diagnosed with Chronic Rhinosinusitis with Nasal Polyps according to the EPOS 2012\r\n consensus criteria\r\n\r\n - Post-operative with a Lund-Kennedy Poly score of <4\r\n\r\n - Baseline SNOT-22 Score ≥ 30\r\n\r\n Exclusion Criteria:\r\n\r\n - Patients with the following comorbidities:\r\n\r\n - GI Hypomotility\r\n\r\n - Heart Failure\r\n\r\n - Liver Failure\r\n\r\n - Kidney Disease\r\n\r\n - Muscular Dystrophy\r\n\r\n - Pregnant or Nursing Females\r\n\r\n - Steroid Dependency\r\n\r\n - Hypertrophic Cardiomyopathy\r\n\r\n - Any Atrial or Ventricular arrhythmia (ie. Atrial fibrillation, atrial flutter, etc..)\r\n\r\n - Resting Heart Rate less than 60 beats per minute\r\n\r\n - Baseline Systolic Blood Pressure less than 110 mmHg\r\n\r\n - Baseline Diastolic Blood Pressure less than 70 mmHg\r\n\r\n - Baseline Mean Arterial Pressure Less than 60 mmHg\r\n\r\n - PR interval less than 0.12 seconds\r\n\r\n - Patients taking the following medications:\r\n\r\n - Aspirin\r\n\r\n - Beta-blockers\r\n\r\n - Cimetidine(Tagamet)\r\n\r\n - Clarithromycin(Biaxin)\r\n\r\n - Cyclosporin\r\n\r\n - Digoxin\r\n\r\n - Disopyramide(Norpace)\r\n\r\n - Diuretics\r\n\r\n - Erythromycin\r\n\r\n - Flecainide\r\n\r\n - HIV Protease Inhibitors(Indinavir, Nelfinavir, Ritonavir)\r\n\r\n - Quinidine\r\n\r\n - Lithium\r\n\r\n - Pioglitazone\r\n\r\n - Rifampin\r\n\r\n - St Johns Wort\r\n\r\n - Patients with cardiac or conduction abnormality picked up by screening EKG\r\n\r\n - Post-op patients with surgery within 3 months prior to enrollment.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Verapamil Hydrochloride Intranasal\n- **Description:** Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.\n- **Mesh Terms:** Verapamil\nSMILES: ['COC1=C(OC)C=C(CCN(C)CCCC(C#N)(C(C)C)C2=CC(OC)=C(OC)C=C2)C=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02451930
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC\n\n**Trial Summary:** \n\n\n The main purpose of this study is to evaluate the safety and efficacy of the combination of\r\n necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer\r\n (NSCLC).\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Stage IV Non-Small Cell Lung Cancer\n\n**Condition Keywords:** ['Lung Neoplasms', 'Carcinoma, Non-Small-Cell Lung']\n\n**ICD Code:** [\"['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - The participant has Stage IV NSCLC.\r\n\r\n - Part A: NSCLC Stage IV (any type)\r\n\r\n - Part B: NSCLC Stage IV (squamous and nonsquamous)\r\n\r\n - Part C: NSCLC Stage IV in Japanese participants (squamous and nonsquamous)\r\n\r\n - The participant must have progressed after 1 platinum-based chemotherapy regimen for\r\n Stage IV NSCLC. Prior therapy with VEGF/VEGFR targeting agents is permitted. Prior\r\n neoadjuvant/adjuvant therapy is permitted. Prior treatment with EGFR-TKI and ALK\r\n inhibitors is mandatory in participants with NSCLC whose tumor has EGFR-activating\r\n mutations or ALK translocations, respectively.\r\n\r\n - Measurable disease at the time of study entry as defined by Response Evaluation\r\n Criteria In Solid Tumors Version 1.1 (RECIST 1.1).\r\n\r\n - The participant has evaluable tumor tissue available for biomarker analyses.\r\n\r\n - The participant has adequate organ function.\r\n\r\n - Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1.\r\n\r\n Exclusion Criteria:\r\n\r\n - The participant is currently enrolled in a clinical trial involving an investigational\r\n product or non-approved use of a drug or device.\r\n\r\n - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 monoclonal antibody.\r\n\r\n - Have a serious concomitant systemic disorder or significant cardiac disease.\r\n\r\n - The participant has undergone major surgery or received anti-cancer monoclonal\r\n antibody therapy in the 30-days prior to study enrollment.\r\n\r\n - The participant has undergone chest irradiation within 2 weeks prior to receiving\r\n study treatment.\r\n\r\n - The participant has brain metastases that are symptomatic.\r\n\r\n - The participant has a history of arterial thromboembolism event (ATE) or venous\r\n thromboembolism event (VTE) within 3 months prior to study enrollment. Participants\r\n with history of VTE beyond 3 months prior to study enrollment can be enrolled if they\r\n are appropriately treated with low molecular weight heparin.\r\n\r\n - The participant has a known allergy / history of hypersensitivity reaction to any of\r\n the treatment components, including any ingredient used in the formulation of\r\n necitumumab or pembrolizumab, or any other contraindication to one of the administered\r\n treatments.\r\n\r\n - The participant has a concurrent active malignancy. Previous history of malignancy is\r\n permitted, provided that the participant has been free of disease for ≥3 years, with\r\n the exception of adequately treated basal or squamous cell carcinoma of the skin,\r\n preinvasive carcinoma of the cervix, or any cancers that in the judgment of the\r\n investigator and sponsor may not affect the interpretation of results (for example,\r\n prostate, bladder).\r\n\r\n - History of interstitial lung disease, pneumonitis, autoimmune disease or syndrome that\r\n requires steroids or immunosuppressive agents.\r\n\r\n - The participant has active infection requiring systemic therapy, including active\r\n tuberculosis or known history of infection with the human immunodeficiency virus (HIV\r\n 1/2 antibodies), or hepatitis B (e.g., HBsAg reactive) and/or C virus (e.g., HCV RNA\r\n [qualitative] is detected).\r\n\r\n - The participant has an active autoimmune disease or a documented history of autoimmune\r\n disease, or a syndrome that requires systemic steroids or immunosuppressive agents.\r\n\r\n - The participant has received a live vaccine within 30 days prior to the first dose of\r\n trial treatment.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Necitumumab', 'Pembrolizumab']\n- **Description:** ['Administered IV', 'Administered IV']\n- **Mesh Terms:** ['Pembrolizumab', 'Necitumumab']\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03427073
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Phase I Dose-escalation Study of Subcutaneous ALM201 in Patients With Advanced Ovarian Cancer and Other Solid Tumours\n\n**Trial Summary:** \n\n\n ALM201/0001 is a Phase I, open-label, dose-escalation study of the safety, tolerability and\r\n pharmacokinetics (PK) of ALM201.\r\n\r\n Part 1 will be a dose-escalation study. Patients with advanced solid tumours will receive\r\n daily doses of ALM201 on Days 1-5, 8-12 and 15-19 in 21 day cycles.\r\n\r\n Part 2 will be a dose-expansion of the Maximum Tolerated Dose (MTD) determined in Part 1.\r\n Patients with advanced ovarian cancer will be enrolled with the main objective to determine\r\n the recommended Phase II dose.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Solid Tumors', 'Ovarian Cancer']\n\n**Condition Keywords:** ['Ovarian Neoplasms', 'Carcinoma, Ovarian Epithelial']\n\n**ICD Code:** ['None', \"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 16 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Part 1 Specific Inclusion Criterion\r\n\r\n *Patients with histologically and/or cytologically confirmed advanced solid tumour for\r\n whom no standard effective therapy is available or felt likely to be of limited\r\n efficacy and in whom a rationale for use of an anti-angiogenic treatment approach\r\n exists. Note: Previous use of anti-angiogenic therapy is allowed if tolerated\r\n\r\n - Part 2 Specific Inclusion Criterion\r\n\r\n *Patients with advanced ovarian cancer, who are intolerant of or whose tumour is\r\n resistant to platinums and who have failed to respond to, or have relapsed following,\r\n standard therapy and whose tumour has a proangiogenic profile as assessed by the\r\n angiogenesis gene signature test. Note: Previous use of anti-angiogenic therapy is\r\n allowed if tolerated.\r\n\r\n - General Inclusion Criteria for all Patients\r\n\r\n - Measurable or evaluable disease.\r\n\r\n - Recovery from previous treatment to baseline or CTCAE ≤ Grade 1, as determined by\r\n CTCAE v4.03 criteria (Appendix B), of reversible toxicities related to prior\r\n treatment, with the exception of alopecia, lymphopenia, other non-clinically\r\n significant adverse events; recovery from previous radiotherapy other than\r\n residual cutaneous effects or stable < Grade 2 gastrointestinal toxicity;\r\n complete recovery from surgery other than stable < Grade 2 toxicity.\r\n\r\n - ECOG Performance Status (PS) of 0 or 1.\r\n\r\n - Acceptable haematological, renal and hepatic\r\n\r\n - Women must have either a negative pregnancy test prior to first study drug\r\n administration or be post menopausal. Male and female patients of childbearing\r\n potential must use appropriate methods birth control.\r\n\r\n - Patients must give written informed consent and understand the requirements of\r\n the study\r\n\r\n Exclusion Criteria:\r\n\r\n For all Patients\r\n\r\n - History of inability to tolerate anti-angiogenic therapies e.g. increased blood\r\n pressure (BP), proteinuria, prior thromboembolic events.\r\n\r\n - Previous history of bowel obstruction, clinical evidence of gastro-intestinal\r\n obstruction, large burden of peritoneal disease or evidence of bowel involvement on\r\n computed tomography.\r\n\r\n - Patents has received:\r\n\r\n - any chemotherapy regimens (including investigational agents) with delayed\r\n toxicity within 4 weeks (6 weeks for prior nitrosourea or mitomycin C) of Cycle\r\n 1, Day 1, or received chemotherapy regimens given continuously or on a weekly\r\n basis which have limited potential for delayed toxicity within 2 weeks of Cycle\r\n 1, Day 1.\r\n\r\n - radiotherapy, immunotherapy or biological agents (includes investigational\r\n agents) within 4 weeks of Cycle 1, Day 1. Localised palliative radiotherapy is\r\n permitted for symptom control.\r\n\r\n - Documented, symptomatic or uncontrolled intracranial metastases or primary\r\n intracerebral tumours.\r\n\r\n - Cancer with leptomeningeal involvement.\r\n\r\n - On therapeutic anti-coagulation (aspirin dosing ≤100 mg per oral (PO) daily allowed).\r\n\r\n - Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ\r\n of the uterine cervix, unless the tumour was treated with curative intent more than 2\r\n years prior to study entry.\r\n\r\n - Active cardiac condition or history of significant cardiac condition. Known human\r\n immunodeficiency virus positivity.\r\n\r\n - Active hepatitis B or C or other active liver disease (other than malignancy).\r\n\r\n - Any active, clinically significant, viral, bacterial, or systemic fungal infection\r\n within 4 weeks prior to Cycle 1, Day 1.\r\n\r\n - Any evidence of severe or uncontrolled systemic conditions or any other issues which\r\n make it undesirable for the patient to participate in the study or which could\r\n jeopardize compliance with the protocol.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ALM201\n- **Description:** Drug: ALM201 administered subcutaneously\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03707041
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model\n\n**Trial Summary:** \n\n\n This was a single centre, randomised, double-blind, placebo-controlled Phase Ib study, to\r\n evaluate the safety, tolerability and chemoprotective activity of P218 in a controlled P.\r\n falciparum sporozoite infection model.\r\n\r\n Healthy men and women, aged 18 to 45 years were to be enrolled in 3 study cohorts and to be\r\n administered either P218 or placebo twice, 48 hours apart. Subjects in cohorts 2 and 3 were\r\n to be inoculated with P. falciparum sporozoites. Enrolment in cohorts was to proceed\r\n sequentially, to facilitate review of data by a Safety Review Team (SRT) before proceeding\r\n with a subsequent cohort.\r\n\r\n In cohort 1, safety and tolerability of P218 was assessed. In cohorts 2 and 3,\r\n chemoprotective activity of P218 against malaria infection was assessed, as well as the\r\n Influence of time of initiation of the P218 treatment on the protective effect.\r\n \n\n**Trial Keywords:** ['malaria', 'PfSPZ Challenge', 'chemoprotection']\n\n**Phase:** Phase 1\n\n**Condition:** Malaria\n\n**Condition Keywords:** Malaria\n\n**ICD Code:** [\"['B54', 'B53.0', 'P37.3', 'P37.4', 'B50.9', 'Z86.13', 'B51.9']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 45 Years\n- **Criteria:** \n Subjects meeting all of the following criteria are eligible to participate in this study:\r\n\r\n 1. Informed Consent Form signed voluntarily before any study-related procedure is\r\n performed, indicating that the subject understands the purpose of and procedures\r\n required for the study and is willing to participate in the study, including\r\n administration of rescue treatment.\r\n\r\n 2. Male or female, between 18 and 45 years old (extremes included) at screening.\r\n\r\n 3. Body weight of at least 50 kg and a body mass index (BMI) of 19 to 30 kg/m2 (extremes\r\n included).\r\n\r\n 4. Good general health without clinically relevant medical illness, physical exam\r\n findings including vital signs, and laboratory abnormalities as determined by the\r\n investigator.\r\n\r\n 5. Willing to adhere to the prohibitions and restrictions (see Section 4.3) specified in\r\n this protocol, including willingness to stay confined to the inpatient unit for\r\n required duration and willingness to avoid to travel outside of Benelux during the\r\n study period.\r\n\r\n 6. Female subjects should fulfil one of the following criteria:\r\n\r\n 1. At least 1 year post-menopausal (amenorrhea >12 months and follicle-stimulating\r\n hormone (FSH) >30 mIU/mL) prior to screening;\r\n\r\n 2. Surgically sterile (bilateral oophorectomy, hysterectomy or tubal ligation);\r\n\r\n 3. Will use contraceptives as outlined in inclusion criteria 7 and 8.\r\n\r\n 7. Female subjects of childbearing potential must agree to the use of a highly effective\r\n method of birth control from screening visit to until 40 days after the last dose of\r\n IMP (covering a full menstrual cycle of 30 days starting after 5 half-lives of last\r\n dose of IMP).\r\n\r\n Note: Highly effective birth control methods include: combined (estrogen and\r\n progestogen containing) oral/intravaginal/transdermal hormonal contraception\r\n associated with inhibition of ovulation, progestogen-only oral/injectable/implantable\r\n hormonal contraception associated with inhibition of ovulation, intrauterine device,\r\n intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner\r\n or sexual abstinence.\r\n\r\n 8. Male subjects who are sexually active with a female partner of childbearing potential\r\n must agree to the use of an effective method of birth control from the day of the\r\n first IMP dose until 100 days thereafter (covering a full sperm cycle of 90 days\r\n starting after 5 half-lives of last dose of IMP).\r\n\r\n Note: Medically acceptable methods of contraception that may be used by the subject\r\n and/or partner include sterilization and vasectomy or a double barrier option\r\n combining oral contraceptive, contraceptive vaginal ring, contraceptive injection,\r\n intrauterine device or etonogestrel implant.\r\n\r\n 9. Female subject has a negative pregnancy test at screening and upon admission in the\r\n clinical unit.\r\n\r\n Note: Pregnancy testing will consist of a serum β-human chorionic gonadotropin (β-HCG)\r\n test at screening and urine β-HCG tests at other visits, in all women.\r\n\r\n Inclusion Criteria - CHMI (controlled human malaria infection) specific:\r\n\r\n 10. Different ways of being reachable 24/7 (e.g. by mobile phone, regular phone or\r\n electronic mail) during the whole study period.\r\n\r\n Subjects meeting any of the following criteria are excluded from participation in this\r\n study:\r\n\r\n 1. Nursing (lactating) women.\r\n\r\n 2. Participation in any other clinical drug or vaccine study within 30 days (or five\r\n half-lives for drugs) preceding the first dose of IMP (whichever is longer), or plans\r\n to participate in other investigational drug or vaccine research during the study\r\n period.\r\n\r\n 3. Blood product donation to any blood bank during the 8 weeks (whole blood) or 4 weeks\r\n (plasma and platelets) prior to admission in the clinical unit.\r\n\r\n 4. ECG outside normal range and deemed clinically relevant by the investigator. Examples\r\n of clinically significant ECG abnormalities for this study include:\r\n\r\n 1. PR-interval >220 ms;\r\n\r\n 2. QRS-complex >120 ms;\r\n\r\n 3. QT interval corrected according to Bazett's formula (QTcB) or QT interval\r\n corrected according to Fridericia's formula [3] (QTcF) >450 ms;\r\n\r\n 4. Pathologic Q wave;\r\n\r\n 5. Significant ST-T wave changes;\r\n\r\n 6. Left or right ventricular hypertrophy;\r\n\r\n 7. Non-sinus rhythm except isolated premature atrial contractions and ventricular\r\n extrasystole <2 per 10 s ECG lead;\r\n\r\n 8. Incomplete left bundle branch block, or complete or intermittent right or left\r\n bundle branch block;\r\n\r\n 9. Second or third degree A-V heart block.\r\n\r\n 5. Seropositive human immunodeficiency virus (HIV) (antibody and antigen), hepatitis B\r\n virus (HBV) (hepatitis B surface antigen [HBsAg]) or hepatitis C virus (HCV)\r\n (antibody) tests.\r\n\r\n 6. History or presence of diagnosed food or known drug allergies (including but not\r\n limited to allergy to any of the antimalarial rescue medications to be used in the\r\n study, see Section 5.2), or history of anaphylaxis or other severe allergic reactions.\r\n\r\n Note: Subjects with seasonal allergies/hay fever, house dust mite or allergy to\r\n animals that are untreated and asymptomatic at the time of dosing can be enrolled in\r\n the study.\r\n\r\n 7. History of convulsion or severe head trauma.\r\n\r\n Note: A medical history of a single febrile convulsion during childhood is not an\r\n exclusion criteria.\r\n\r\n 8. History of serious psychiatric condition that may affect participation in the study or\r\n preclude compliance with the protocol, including but not limited to past or present\r\n psychoses, disorders requiring lithium, a history of attempted or planned suicide,\r\n more than one previous episode of major depression, any previous single episode of\r\n major depression lasting for or requiring treatment for more than 6 months, or any\r\n episode of major depression during the 5 years preceding screening.\r\n\r\n Note: The Beck Depression Inventory (Attachment 2) will be used as an objective tool\r\n for the assessment of depression at screening. In addition to the conditions listed\r\n above, subjects with a score of 20 or more on the Beck Depression Inventory and/or a\r\n response of 1, 2 or 3 for item 9 of this inventory (related to suicidal ideation) will\r\n not be eligible for participation. Subjects with a Beck score of 17 to 19 may be\r\n enrolled at the discretion of the Investigator if they do not have a history of the\r\n psychiatric conditions mentioned in this criterion and their mental state is not\r\n considered to pose additional risk to the health of the volunteer or to the execution\r\n of the study and interpretation of the data gathered.\r\n\r\n 9. A medical, occupational or family problem as a result of alcohol or illicit drug abuse\r\n during the past 12 months or current alcohol or illicit drug abuse or addiction\r\n (positive alcohol breath test or positive drug screen for amphetamines, barbiturates,\r\n benzodiazepines, cannabinoids, cocaine or opiates at screening or upon check-in at the\r\n clinical unit).\r\n\r\n Note: Excessive use of alcohol is an intake of >21 units per week for males and >14\r\n units per week for females where one alcohol unit is defined as 10 mL or 8 g of pure\r\n alcohol. A single unit is equal to one 25-mL (single) measure of whisky (alcohol by\r\n volume [ABV] 40%), or a third of a pint of beer (190 mL; ABV 5-6%) or half a standard\r\n (175 mL) glass of wine (ABV 12%).\r\n\r\n 10. Subjects are non-smokers or ex-smokers for more than 90 days prior to screening or\r\n smoke no more than 5 cigarettes per day. If users of nicotine products (i.e. spray,\r\n patch, e-cigarette, etc.) they should use the equivalent of no more than 5 cigarettes\r\n per day. Subjects must agree to abstain from smoking while in the unit.\r\n\r\n 11. Use of any prescription drugs, herbal supplements (e.g. St John's Wort) or\r\n over-the-counter medication within 7 days or five half-lives (whichever is longer)\r\n prior to the first IMP administration, or an anticipated requirement for the use of\r\n these during the course of the study (See Section 6.2).\r\n\r\n Note: If necessary, the incidental use of non-steroidal anti-inflammatory drugs\r\n (NSAIDs), paracetamol (2g/day, 10 gr/week), vitamins and topical treatments may be\r\n acceptable after approval by the study Sponsor and will be documented in the eSource\r\n system. The use of nutritional supplements during this time that are not believed to\r\n have the potential to affect subject safety nor the overall results of the study, may\r\n be permitted on a case-by-case basis following approval by the Sponsor in consultation\r\n with the Investigator.\r\n\r\n 12. Any surgical or medical condition possibly affecting drug absorption (e.g.\r\n cholecystectomy, gastrectomy, bowel disease), distribution, metabolism or excretion.\r\n\r\n 13. Any history of gallbladder disease, including cholecystitis and/or cholelithiasis.\r\n\r\n 14. History of megaloblastic anaemia or folate deficiency.\r\n\r\n 15. Personnel (e.g. investigator, sub-investigator, research assistant, pharmacist, study\r\n coordinator or anyone mentioned in the delegation log) directly involved in the\r\n conduct of the study.\r\n\r\n 16. Any condition that in the opinion of the investigator would jeopardize the safety or\r\n rights of a person participating in the trial or would render the person unable to\r\n comply with the protocol.\r\n\r\n Exclusion Criteria - CHMI specific:\r\n\r\n 17. Glucose-6-phosphate dehydrogenase (G6PD) deficiency (due to possible hemolysis induced\r\n by primaquine treatment at study end in G6PD deficient subjects).\r\n\r\n 18. Personal history of malaria.\r\n\r\n 19. Volunteer has travelled to or lived in a malaria-endemic area for more than 4 weeks\r\n during the 12 months prior to first IMP administration, or spent any time in an\r\n endemic area during the 4 weeks prior to first IMP administration.\r\n\r\n 20. Plans to travel to malaria-endemic region during the study period up to last follow-up\r\n visit.\r\n\r\n 21. Previous participation in any malaria vaccine or CHMI study.\r\n\r\n 22. Falling in moderate or higher risk category for a fatal or non-fatal cardiovascular\r\n event within 10 years (≥5%) determined by a validated risk estimation system e.g.\r\n SCORE [13].\r\n\r\n 23. Use of medications known to interact with atovaquone-proguanil (Malarone®),\r\n artemether-lumefantrine (Riamet®) or primaquine (Primaquine®) such as cimetidine,\r\n metoclopramide or antacids, or an anticipated requirement for the use of these at any\r\n point during the study period (see Section 6.2).\r\n\r\n 24. Use of systemic antibiotics with known antimalarial activity within 30 days (or 5\r\n half-lives whichever is longer) of first IMP administration (e.g.\r\n trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin,\r\n fluoroquinolones or azithromycin) or an anticipated requirement for the use of these\r\n during the study period (see Section 6.2).\r\n\r\n 25. Receipt of blood or blood-derived products (including immunoglobulin) within 3 months\r\n prior to screening. Receipt of packed red blood cells given for an emergent indication\r\n in an otherwise healthy person, and not required as ongoing treatment is not\r\n exclusionary (for example packed red blood cells emergently given during an elective\r\n surgery).\r\n\r\n Note: In case of an out-of-range clinical laboratory test, vital sign or ECG value that\r\n will determine a subject's eligibility, or in case of a positive drug screen, a retest or\r\n expert evaluation can be requested. Results of any retest must be available prior to\r\n inoculation. The result of the retest will be considered for subject eligibility at the\r\n investigator's discretion. Subjects can be rescreened at the discretion of the\r\n investigator.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['P218 (1000 mg) Oral Capsules', 'Placebo Oral Capsules', 'P218 (100 mg) Oral Capsules', 'PfSPZ Challenge']\n- **Description:** ['1000 mg P218 (4 x 250 mg capsules)', 'Placebo capsules matched to the P218 capsules with regard to appearance and taste', '100 mg P218 (2 x 50 mg capsules)', '3200 P. falciparum Sporozoites by direct venous inoculation (DVI)']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT00373399
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEffects of Smoked Marijuana on Risk Taking and Decision Making Tasks\n\n**Trial Summary:** \n\n\n The purpose of this study is to investigate the effects of smoked marijuana on both risk\r\n taking and decision making tasks.\r\n \n\n**Trial Keywords:** ['Cannabinoids', 'Risk taking', 'Decision making']\n\n**Phase:** Phase 1\n\n**Condition:** Marijuana Use Disorder\n\n**Condition Keywords:** ['Marijuana Abuse', 'Marijuana Use']\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 21 Years\n- **Maximum Age:** 45 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Current marijuana use\r\n\r\n - 21-45 years of age\r\n\r\n - Practicing an effective form of birth control\r\n\r\n - Not seeking treatment for marijuana use\r\n\r\n Exclusion Criteria:\r\n\r\n - Current, repeated illicit drug use other than marijuana\r\n\r\n - Presence of significant medical illness (e.g., diabetes, cardiovascular disease,\r\n hypertension)\r\n\r\n - Laboratory tests outside normal limits that are clinically unacceptable to the study\r\n physician (BP > 140/90; hematocrit < 34 for women, < 36 for men)\r\n\r\n - Significant adverse reaction to marijuana\r\n\r\n - Current parole or probation\r\n\r\n - Pregnancy or current lactation\r\n\r\n - Recent history of significant violent behavior\r\n\r\n - Major current Axis I psychopathology (e.g., mood disorder with functional impairment\r\n or suicide risk, anxiety disorder, schizophrenia\r\n\r\n - History of heart disease\r\n\r\n - Current use of any over-the-counter or prescription medication from which the\r\n volunteer cannot be withdrawn\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Inactive Marijuana (0% THC)', 'Low THC marijuana (1.8 %THC)', 'High THC marijuana (3.9% THC)']\n- **Description:** ['Placebo marijuana was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.', 'Active marijuana (1.8 % THC) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.', 'Active marijuana (3.9%) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.']\n- **Mesh Terms:** Dronabinol\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02432716
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nInvestigation of the Safety of Intranasal Glulisine in Down Syndrome\n\n**Trial Summary:** \n\n\n This study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot\r\n study designed to assess the safety of intranasally (IN) delivered glulisine versus placebo\r\n in patients with DS. Subjects will be randomized into this cross-over study and within\r\n subject comparisons conducted between single treatment of intranasal insulin glulisine and\r\n single treatment of intranasal placebo. All subjects will also receive a single treatment of\r\n placebo prior to randomization to ensure adherence to study procedures.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Down Syndrome\n\n**Condition Keywords:** ['Down Syndrome', 'Syndrome']\n\n**ICD Code:** [\"['Q90.9']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 35 Years\n- **Maximum Age:** 80 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Male or female aged 35-80 years with a Down syndrome diagnosis that is confirmed by\r\n karyotype.\r\n\r\n - Vital signs must be within normal limits for their age. (Medically treated\r\n hypertension will be allowed).\r\n\r\n - Must have an electrocardiogram free of clinically significant findings.\r\n\r\n - Must have an authorized representative to provide written informed consent.\r\n\r\n - Level of speech and comprehension of verbal commands are sufficient to understand and\r\n to answer simple requests.\r\n\r\n - Must have a reliable caregiver or family member who agrees to accompany the subject to\r\n all visits, provide information about the subject as required by this protocol.\r\n\r\n - Must be independent for activities of daily living.\r\n\r\n - Must tolerate the initial IN treatment of placebo and adhere to study procedures.\r\n\r\n Exclusion Criteria:\r\n\r\n - Any current psychiatric or neurologic diagnosis other than Down syndrome or Down\r\n syndrome with dementia that is judged to impact cognition.\r\n\r\n - Subjects who currently meet or have within the past five years met DSM-IV (Diagnostic\r\n and Statistical Manual) criteria for drug or alcohol abuse or dependence.\r\n\r\n - Subjects residing in a skilled nursing facility or subjects who are anticipated to\r\n enter a nursing home within the next 6 months. (Subjects may reside in group homes,\r\n assisted living, or other residential settings where they do not require 24 hour\r\n skilled nursing.)\r\n\r\n - Subjects receiving any experimental drug for Down syndrome within the past 30 days of\r\n screening visit.\r\n\r\n - Subjects with significant allergies to or other significant intolerance insulin.\r\n\r\n - Presence of active seizure disorder.\r\n\r\n - Presence of significant aggression or agitation that may impact participation with\r\n testing and IN administration. All subjects must have NPI-C aggression and agitation\r\n subscore ≤ 4 (severity ≤ 2; frequency ≤ 2).\r\n\r\n - Significant cerebrovascular disease with Modified Hachinski Score>4.\r\n\r\n - Subjects who may not be able to comply with the protocol or perform the outcomes\r\n measures due to significant hearing or visual impairment or other issues judged\r\n relevant by the investigators.\r\n\r\n - Subject has been diagnosed with any form of diabetes mellitus, actively takes insulin,\r\n or has HbA1c > 6.1% at screening.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Insulin glulisine', 'Saline']\n- **Description:** ['Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study', 'Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study']\n- **Mesh Terms:** ['Insulin', 'Insulin, Globin Zinc', 'Insulin glulisine']\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT05382104
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nMaribavir Food-Effect Study in Healthy Adults Participants\n\n**Trial Summary:** \n\n\n The main goals of this study are: 1) To assess the relative bioavailability of a single oral\r\n dose of 400 mg maribavir commercial (marketed) tablet formulation administered with a\r\n low-fat/low-calorie meal relative to administration under fasting conditions. 2) To assess\r\n the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed)\r\n tablet formulation administered with a high-fat/high calorie meal relative to administration\r\n under fasting conditions.\r\n\r\n A single dose of 400 mg maribavir (commercial [marketed] tablet formulation) will be\r\n administered orally under 3 different feeding conditions:\r\n\r\n 1. Fasting (Treatment A),\r\n\r\n 2. Fed following a low-fat/low-calorie meal (Treatment B), and\r\n\r\n 3. Fed following a high fat/high-calorie meal (Treatment C).\r\n\r\n There will be a washout period of a minimum of 72 hours between each single dose of\r\n investigational drug (ID) administration on Day 1 in each treatment cycle of 3 days.\r\n\r\n Pharmacokinetic samples will be collected at pre-dose and up to 36 hours post-dose in each\r\n treatment period.\r\n\r\n Safety and tolerability will be assessed throughout the study by Treatment Emergent Adverse\r\n Events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy Volunteers\n\n**Condition Keywords:** None\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 19 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion Criteria\r\n\r\n Participants must fulfill the following inclusion criteria before the first dose of the\r\n Investigational drug (ID) to be eligible for participation in the study:\r\n\r\n - An understanding, ability, and willingness to fully comply with study procedures and\r\n restrictions and ability to voluntarily provide written, signed, and dated (personally\r\n or via a legally authorized representative) informed consent\r\n\r\n - Age 19-55 years, inclusive at the time of consent, at the screening visit.\r\n\r\n - Male, or non-pregnant, non-breastfeeding female who agrees to comply with any\r\n applicable contraceptive requirements of the protocol or female of non-childbearing\r\n potential.\r\n\r\n - Healthy as determined by the Investigator or designee on the basis of screening\r\n evaluations and medical history.\r\n\r\n - Hemoglobin for males greater than or equal to (>=) 135.0 gram per liter (g/L) and\r\n females >=120.0 g/L at the screening visit and on Day 1 of Treatment Period 1.\r\n\r\n - Body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2),\r\n inclusive with a body weight greater than (>) 50 kilogram (kg) (110 pound [lbs]), at\r\n the screening visit.\r\n\r\n - Ability to swallow a dose of the ID.\r\n\r\n Exclusion Criteria\r\n\r\n Participants must not be enrolled in the study if they meet any of the following criteria\r\n before the first dose of the ID:\r\n\r\n - History or presence of gastritis, Gastrointestinal (GI) tract, hepatic disorder or\r\n cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease or\r\n other clinical GI condition and history of any hematological, hepatic, respiratory,\r\n cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or\r\n current recurrent disease that could affect the action, absorption, or disposition of\r\n the ID, or clinical or laboratory assessments.\r\n\r\n - Current or relevant history of physical or psychiatric illness, any medical disorder\r\n that may require treatment or make the participant unlikely to fully complete the\r\n study, or any condition that presents undue risk from the ID or procedures.\r\n\r\n - Known or suspected intolerance or hypersensitivity to the ID, closely related\r\n compounds, or any of the stated ingredients and excipients.\r\n\r\n - Significant illness, as judged by the Investigator or designee, within 2 weeks of the\r\n first dose of the ID.\r\n\r\n - Has diarrhea within 4 hours of the first dose of the ID.\r\n\r\n - Donors of blood or blood products (e.g., plasma or platelets) within 60 days prior to\r\n receiving the first dose of the ID.\r\n\r\n - Within 30 days prior to the first dose of the ID:\r\n\r\n - Have used any investigational product (if elimination half-life is less than [<]\r\n 6 days, otherwise 5 half-lives).\r\n\r\n - Have been enrolled in a clinical study (including vaccine studies) that may\r\n impact this study.\r\n\r\n - Have had any substantial changes in eating habits.\r\n\r\n - Systolic blood pressure >140 millimeters of mercury (mmHg) or <90 mmHg, and diastolic\r\n blood pressure >90 mmHg or <50 mmHg, at the screening visit.\r\n\r\n - Twelve-lead ECG with corrected QT interval (QTc) >450 millisecond (msec) at the\r\n screening visit.\r\n\r\n - Known history of alcohol or other substance abuse within the last year.\r\n\r\n - Male participants who consume more than 21 units of alcohol per week or 3 units per\r\n day. Female participants who consume more than 14 units of alcohol per week or 2 units\r\n per day.\r\n\r\n - A positive screen for alcohol or drugs of abuse at the screening visit or on Day -1 of\r\n Treatment Period 1.\r\n\r\n - A positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or\r\n Hepatitis C virus (HCV) antibody screen at the screening visit.\r\n\r\n - Use of tobacco in any form or other nicotine-containing products in any form. Ex-users\r\n must self-report that they have stopped using tobacco for at least 3 months prior to\r\n receiving the first dose of the ID.\r\n\r\n - Routine consumption of more than 2 units of caffeine per day or participants who\r\n experience caffeine withdrawal headaches. Decaffeinated coffee, tea, or cola are not\r\n considered to contain caffeine.\r\n\r\n - Current use of any prescription medication with the exception of hormonal\r\n contraceptives and hormonal replacement therapy.\r\n\r\n - Current use of antacids, proton pump inhibitors, or H2 antagonists within 14 days of\r\n the first dose of the ID.\r\n\r\n - Inability or unwillingness to consume 100 percent of high-fat meal or low-fat meal\r\n (including participants with lactose or gluten intolerance).\r\n\r\n - Recent history (within 1 month) of oral/nasal cavity infections, history of\r\n gastroesophageal reflux, asthma treatment with albuterol, or zinc supplementation.\r\n\r\n - Participants with dry mouth syndrome or burning mouth syndrome or participants\r\n suffering from dysgeusia.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Maribavir\n- **Description:** Maribavir single 400 mg tablet under three different food conditions (fasted, low fat/low calorie meal, and high fat/high calorie meal) depending upon the treatment sequence allocation on Day 1 of each treatment period.\n- **Mesh Terms:** Maribavir\nSMILES: ['CC(C)NC1=NC2=CC(Cl)=C(Cl)C=C2N1[C@H]1O[C@@H](CO)[C@H](O)[C@@H]1O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT01640873
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)\n\n**Trial Summary:** \n\n\n This study will assess the initial safety, tolerability, pharmacokinetics, and\r\n pharmacodynamics of MK-8655, after single and multiple daily oral administrations to\r\n participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting\r\n plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.\r\n \n\n**Trial Keywords:** Type 2 Diabetes\n\n**Phase:** Phase 1\n\n**Condition:** Type 2 Diabetes\n\n**Condition Keywords:** ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2']\n\n**ICD Code:** [\"['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Male or female of non-child bearing potential\r\n\r\n - Body Mass Index ≤40 kg/m^2\r\n\r\n - Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with\r\n metformin only\r\n\r\n - In good health except for T2DM\r\n\r\n - Willing to follow a standard diet\r\n\r\n - Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months\r\n\r\n Exclusion Criteria:\r\n\r\n - Mentally or legally incapacitated\r\n\r\n - History of stroke, chronic seizures, or major neurological disorder\r\n\r\n - History of clinically significant endocrine (except T2DM), gastrointestinal,\r\n cardiovascular, hematological, hepatic, immunological, renal, respiratory, or\r\n genitourinary abnormalities or diseases\r\n\r\n - History of neoplastic or myeloproliferative diseases\r\n\r\n - Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or\r\n frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety\r\n\r\n - Has a history of Type 1 Diabetes and/or history of ketoacidosis\r\n\r\n - Use of any lipid-lowering therapies in the past 3 months\r\n\r\n - Non-permitted medication for a co-morbid condition\r\n\r\n - Excessive alcohol or caffeine use\r\n\r\n - Participation in another investigational study within 4 weeks prior to this study\r\n\r\n - A history of significant multiple and/or severe allergies or anaphylactic reactions\r\n\r\n - Regular user of any illicit drugs or history of alcohol abuse within 6 months\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['MK-8655', 'Placebo']\n- **Description:** ['Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.', 'Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04840849
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEvaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults\n\n**Trial Summary:** \n\n\n The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of\r\n Nirsevimab in Healthy Chinese Adults.\r\n \n\n**Trial Keywords:** ['PK', 'safety', 'tolerability', 'Nirsevimab', 'healthy Chinese Adults', 'Respiratory Syncytial Viral (RSV)']\n\n**Phase:** Phase 1\n\n**Condition:** Evaluate PK Profile\n\n**Condition Keywords:** None\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 45 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Age 18 to 45 years\r\n\r\n 2. Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2\r\n\r\n 3. Healthy Chinese subjects (both male and female)\r\n\r\n 4. Normotensive\r\n\r\n 5. Normal electrocardiogram (ECG) within 28 days prior to Day 1\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Acute illness at study entry (pre-dose on Day 1)\r\n\r\n 2. Fever ≥99.5°F (37.5°C) on day of dosing\r\n\r\n 3. Any drug therapy within 14 days prior to Day 1 (except contraceptives).\r\n\r\n 4. Receipt of immunoglobulin or blood products within 6 months prior to study entry.\r\n\r\n 5. Receipt of any investigational drug therapy within 120 days prior to investigational\r\n product dosing or planned to receive any investigational drug therapy within 150 days\r\n after investigational product dosing.\r\n\r\n 6. Previous receipt of any marketed or investigational mAb.\r\n\r\n 7. Previous vaccination against RSV.\r\n\r\n 8. History of immunodeficiency or receipt of immunosuppressive medications during the\r\n prior year.\r\n\r\n 9. History of asthma.\r\n\r\n 10. History of autoimmune disorder.\r\n\r\n 11. Evidence of any systemic disease on physical examination.\r\n\r\n 12. Evidence of infection with hepatitis A, B, or C virus, syphilis, or human\r\n immunodeficiency virus.\r\n\r\n 13. Any clinically significant abnormal laboratory assessments at screening.\r\n\r\n 14. Pregnant or nursing mother.\r\n\r\n 15. Alcohol or drug abuse\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['nirsevimab', 'Placebo']\n- **Description:** ['Drug: injection, a single fixed IM dose on day 1 only.', 'Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02530905
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nDose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients\n\n**Trial Summary:** \n\n\n This is a first-in-human dose-titration and open-label extension study to assess safety,\r\n tolerability, and pharmacokinetics of SRP-4045 in advanced-stage Duchenne muscular dystrophy\r\n (DMD) patients with deletions amenable to exon 45 skipping.\r\n \n\n**Trial Keywords:** ['Duchenne muscular dystrophy', 'Exon Skipping']\n\n**Phase:** Phase 1\n\n**Condition:** Duchenne Muscular Dystrophy\n\n**Condition Keywords:** ['Muscular Dystrophies', 'Muscular Dystrophy, Duchenne']\n\n**ICD Code:** [\"['G71.01']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** Male\n- **Minimum Age:** 7 Years\n- **Maximum Age:** 21 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Genotypically confirmed DMD (amenable to exon 45 skipping).\r\n\r\n - Stable cardiac and pulmonary function.\r\n\r\n - Limited or no ambulation.\r\n\r\n - On a stable dose of oral corticosteroids for at least 24 weeks OR has not received\r\n corticosteroids for at least 24 weeks.\r\n\r\n Exclusion Criteria:\r\n\r\n - Current or previous treatment with the experimental agents SMT C1100 (BMN-195) or\r\n PRO045.\r\n\r\n - Other experimental treatment in the past 12 weeks.\r\n\r\n - If on cardiac medication, must be on a stable dose for the past 12 weeks.\r\n\r\n - Major surgery within the past 3 months.\r\n\r\n Other inclusion/exclusion criteria apply.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['SRP-4045', 'Placebo']\n- **Description:** ['SRP-4045 solution for IV infusion.', 'SRP-4045 placebo-matching solution for IV infusion.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02919449
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nDose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab\n\n**Trial Summary:** \n\n\n This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of\r\n attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and\r\n metastatic NSCLC.\r\n \n\n**Trial Keywords:** Lung Cancer Measles Nivolumab Opdivo\n\n**Phase:** Phase 1\n\n**Condition:** Recurrent Non-Small Cell Lung Cancer\n\n**Condition Keywords:** ['Measles', 'Lung Neoplasms', 'Carcinoma, Non-Small-Cell Lung']\n\n**ICD Code:** [\"['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Key Inclusion Criteria:\r\n\r\n - Diagnosis of metastatic lung cancer, with histologic confirmation of the primary NSCLC\r\n histology and with at least one lesion amenable for intra-tumoral injection of MV-NIS.\r\n\r\n - Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC.\r\n\r\n - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.\r\n\r\n - Ability to provide informed consent.\r\n\r\n - Adequate hematological, liver and kidney function.\r\n\r\n - Must be willing to implement contraception throughout study and for the 8 weeks\r\n following last study drug administration.\r\n\r\n Key Exclusion Criteria:\r\n\r\n - Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration.\r\n Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to\r\n registration\r\n\r\n - Other concurrent investigational therapy (utilized for a non-FDA-approved indication\r\n and in the context of a research investigation).\r\n\r\n - Pregnant women.\r\n\r\n - Nursing women.\r\n\r\n - Men or women of childbearing potential who are unwilling to employ adequate\r\n contraception during treatment and 8 weeks following the completion of study drug\r\n treatment.\r\n\r\n - Allergy to measles vaccine or history of severe reaction to prior measles vaccination.\r\n\r\n - History of organ transplantation.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['MV-NIS', 'Atezolizumab']\n- **Description:** ['This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC', 'Atezolizumab will be administered every 3 weeks']\n- **Mesh Terms:** Atezolizumab\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT01393990
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of LY2228820 in Participants With Advanced Cancer\n\n**Trial Summary:** \n\n\n The objective of this study is to determine a safe dose of LY2228820 that may be given to\r\n participants with advanced cancer. Part A of this study will consist of dose escalation, and\r\n Part B will consist of dose confirmation.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Advanced Cancer\n\n**Condition Keywords:** Neoplasms\n\n**ICD Code:** [\"['K74.02', 'G47.22', 'H35.3133', 'H35.3134', 'H35.3113', 'H35.3114', 'H35.3123']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Have histological or cytological evidence of a diagnosis of cancer (including\r\n lymphoma) that is advanced or metastatic disease for which no therapy of higher\r\n priority (approved therapies or therapies with published substantial evidence of\r\n effectiveness) is available, or for whom no standard therapy exists\r\n\r\n - Have the presence of measurable or nonmeasurable disease as defined by Modified\r\n Response Evaluation Criteria in Solid Tumors (mRECIST)\r\n\r\n - Have adequate hematologic, renal, and hepatic organ function\r\n\r\n - Have a performance status of less than or equal to 2 on the Eastern Cooperative\r\n Oncology Group (ECOG) scale\r\n\r\n - Have discontinued all previous therapies for cancer, including chemotherapy,\r\n radiotherapy, or other investigational therapy for at least 14 days (42 days for\r\n mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute\r\n effects of therapy\r\n\r\n - Males and females with reproductive potential must agree to use medically approved\r\n contraceptive precautions during the trial and for 3 months following the last dose of\r\n study drug\r\n\r\n - Females with child bearing potential must have had a negative serum pregnancy test\r\n less than or equal to 7 days prior to the first dose of study drug\r\n\r\n - Have an estimated life expectancy of ≥ 12 weeks\r\n\r\n - Are able to swallow capsules and/or tablets\r\n\r\n Exclusion Criteria:\r\n\r\n - Have received treatment within 14 days of the initial dose of study drug with a drug\r\n that has not received regulatory approval for any indication\r\n\r\n - Have a history of major surgical resection involving the stomach or small bowel, or\r\n have serious preexisting medical conditions (based on judgment of the investigator)\r\n\r\n - Have symptomatic central nervous system malignancy or metastasis (screening is not\r\n required)\r\n\r\n - Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis)\r\n\r\n - Have an active hematologic malignancy other than lymphoma\r\n\r\n - Have known positive test results in human immunodeficiency virus (HIV), hepatitis B\r\n surface antigen (HBSAg), or hepatitis C antibodies (HCAb). Screening at baseline will\r\n not be required for enrollment\r\n\r\n - Concurrent administration of any immunosuppressive therapy\r\n\r\n - Females who are pregnant or lactating\r\n\r\n - Have received, within 7 days of the initial dose of study drug, either grapefruit\r\n juice or treatment with a drug that is a known inhibitor or inducer of Cytochrome P450\r\n Enzyme 3A4 (CYP3A4). In addition, participants should not receive grapefruit juice or\r\n treatment with a CYP3A4 inhibitor or inducer during the study\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['LY2228820', 'Midazolam', 'Tamoxifen']\n- **Description:** Administered orally\n- **Mesh Terms:** ['Tamoxifen', 'Midazolam']\nSMILES: ['CC1=NC=C2CN=C(C3=CC=CC=C3F)C3=C(C=CC(Cl)=C3)N12', 'CC\\\\C(=C(/C1=CC=CC=C1)C1=CC=C(OCCN(C)C)C=C1)C1=CC=CC=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT04448561
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants\n\n**Trial Summary:** \n\n\n The primary purpose of this study was to assess the safety and tolerability of multiple doses\r\n of ASP8062 or placebo alone and in combination with a single dose of morphine.\r\n\r\n This study also assessed the potential for pharmacokinetic interaction between ASP8062 and\r\n morphine.\r\n \n\n**Trial Keywords:** ['Opioid Use Disorder', 'pharmacokinetic', 'ASP8062', 'morphine']\n\n**Phase:** Phase 1\n\n**Condition:** Opioid Use Disorder\n\n**Condition Keywords:** Opioid-Related Disorders\n\n**ICD Code:** [\"['F11.94', 'F11.982', 'F11.988', 'F11.99', 'F11.959', 'F11.950', 'F11.951']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 60 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Participant is a recreational opioid user who has used opioids for nontherapeutic\r\n (recreational) purposes on at least 10 occasions within their lifetime, with at least\r\n 1 opioid use in the last 90 days.\r\n\r\n - Participant has a body mass index (BMI) range of 18 to 36 kg/m^2, inclusive and weighs\r\n at least 50 kg at screening.\r\n\r\n - Female participant is not pregnant and at least 1 of the following conditions apply:\r\n\r\n - Not a woman of childbearing potential (WOCBP)\r\n\r\n - WOCBP who agrees to follow the contraceptive guidance from the time of informed\r\n consent through at least 28 days after final investigational product (IP)\r\n administration.\r\n\r\n - Female participant must agree not to breastfeed starting at screening and throughout\r\n the study period and for 28 days after final IP administration.\r\n\r\n - Female participant must not donate ova starting at first dose of IP and throughout the\r\n study period and for 28 days after final IP administration.\r\n\r\n - Male participant with female partner(s) of childbearing potential (including\r\n breastfeeding partner[s]) must agree to use contraception throughout the treatment\r\n period and for 90 days after final IP administration.\r\n\r\n - Male participant must not donate sperm during the treatment period and for 90 days\r\n after final IP administration.\r\n\r\n - Male participant with a pregnant partner(s) must agree to remain abstinent or use a\r\n condom with spermicide for the duration of the pregnancy throughout the study period\r\n and for 90 days after final IP administration.\r\n\r\n - Participant agrees to not participate in another interventional study while\r\n participating in the present study.\r\n\r\n Exclusion Criteria:\r\n\r\n - Participant has received any investigational therapy within 28 days or 5 half-lives,\r\n whichever is longer, prior to screening.\r\n\r\n - Participant has any condition which makes the participant unsuitable for study\r\n participation.\r\n\r\n - Female participant who has been pregnant within 6 months prior to screening or\r\n breastfeeding within 3 months prior to screening.\r\n\r\n - Participant has a known or suspected hypersensitivity to ASP8062 or morphine and/or\r\n other opioids, or any components of the formulations used.\r\n\r\n - Participant has had previous exposure with ASP8062.\r\n\r\n - Participant has any of the liver function tests (alkaline phosphatase [ALP], alanine\r\n aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase\r\n and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal (ULN) on day -1. In such a\r\n case, the assessment may be repeated once.\r\n\r\n - Participant has any clinically significant history of allergic conditions (including\r\n drug allergies, asthma or anaphylactic reactions, but excluding untreated,\r\n asymptomatic, seasonal allergies) prior to first IP administration.\r\n\r\n - Participant has any history or evidence of any clinically significant cardiovascular,\r\n gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,\r\n urologic, pulmonary, neurologic, dermatologic, renal and/or other major disease or\r\n malignancy with exception of history of cholecystectomy.\r\n\r\n - Participant has a history of moderate or severe use disorder for any substance other\r\n than caffeine or tobacco (based on the Diagnostic and Statistical Manual of Mental\r\n Disorders, edition 5 (DSM-5) criteria).\r\n\r\n - Participant has a history or presence of any clinically significant psychiatric\r\n disorders such as, bipolar 1, schizophrenia, schizoaffective disorder or major\r\n depressive disorders.\r\n\r\n - Participant has had recent suicidal ideation within the last 12 months or participant\r\n who is at significant risk to commit suicide using the Baseline/Screening\r\n Columbia-suicide severity rating scale (C-SSRS) at screening and the Since Last Visit\r\n C-SSRS on day -1.\r\n\r\n - Participant has/had febrile illness or symptomatic, viral, bacterial (including upper\r\n respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day\r\n -1.\r\n\r\n - Participant has any clinically significant abnormality following an investigator's\r\n review of the physical examination, ECG and protocol-defined clinical laboratory tests\r\n at screening or on day -1.\r\n\r\n - Participant has a mean pulse < 50 or > 90 bpm; mean systolic blood pressure > 150\r\n mmHg; mean diastolic blood pressure > 95 mmHg (measurements taken in duplicate after\r\n participant has been resting in the supine position for at least 5 minutes) on day -1.\r\n If the mean blood pressure exceeds the limits above, 1 additional duplicate may be\r\n taken.\r\n\r\n - Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of >\r\n 450 msec (for male participants) and > 470 msec (for female participants) on day -1.\r\n If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.\r\n\r\n - Participant has a positive test for amphetamines, barbiturates, benzodiazepines,\r\n cocaine, phencyclidine, alcohol and/or opiates on day -1. Positive\r\n tetrahydrocannabinol is not exclusionary and a cannabis intoxication evaluation will\r\n be performed. Participant may be reconsidered.\r\n\r\n - Participant has used any prescribed or nonprescribed drugs (including vitamins and\r\n natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to first IP\r\n administration, except for occasional use of acetaminophen (up to 2 g/day), topical\r\n dermatological products, including corticosteroid products, hormonal contraceptives\r\n and hormone replacement therapy (HRT).\r\n\r\n - Participant must be willing to abstain from smoking (including use of\r\n tobacco-containing products and nicotine or nicotine-containing products [e.g.,\r\n electronic vapes]) from at least 1 hour predose through at least 8 hours postdose on\r\n days 9 and 10.\r\n\r\n - Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in\r\n the 3 months prior to day -1.\r\n\r\n - Participant has had significant blood loss, donated approximately 500 mL of whole\r\n blood (excluding plasma donation) within 56 days prior to screening or donated plasma\r\n within 7 days prior to day -1.\r\n\r\n - Participant has a positive serology test for hepatitis B surface antigen, hepatitis C\r\n virus antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or\r\n type 2 at screening.\r\n\r\n - Participant has loss of ability to freely provide consent through imprisonment or\r\n involuntary incarceration for treatment of either a psychiatric or physical (e.g.,\r\n infectious disease) illness.\r\n\r\n - Participant is an employee of Astellas, the study-related contract research\r\n organizations (CROs) or the clinical unit.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['ASP8082', 'morphine', 'Placebo']\n- **Description:** ['oral', 'oral', 'oral']\n- **Mesh Terms:** Morphine\nSMILES: ['[H][C@@]12OC3=C(O)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])C=C[C@@H]2O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04201197
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nInteractions Between Cannabinoids and Cytochrome P450-Metabolized Drugs\n\n**Trial Summary:** \n\n\n This study will evaluate drug-drug interactions between cannabis extracts containing\r\n Tetrahydrocannabinol (THC) and THC+ Cannabinoids (CBD) and probe drugs for select CYP450\r\n pathways including: caffeine (CYP1A2), omeprazole (CYP2C19), losartan (CYP2C9),\r\n dextromethorphan (CYP2D6), and midazolam (CYP3A).\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Drug-Interactions\n\n**Condition Keywords:** None\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 50 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Healthy adult between 18-50 years old\r\n\r\n - BMI between 18 to 34 kg/m2\r\n\r\n - Willing to use birth control\r\n\r\n - Willing to abstain from all medications and citrus fruits for the duration of the\r\n study\r\n\r\n Exclusion Criteria:\r\n\r\n - Medical or psychiatric illness judged by the investigator to put the participant at\r\n greater risk of experiencing an adverse event due to drug exposure or completion of\r\n other study procedures.\r\n\r\n - Use of medications which, in the opinion of the investigator or medical staff, will\r\n interfere with the study outcomes or the safety of the participant.\r\n\r\n - Clinically significant impairment of kidney, liver, or thyroid function (serum\r\n creatinine >1.2 mg/ml (kidney), liver function tests >3x the upper limit of normal\r\n (alanine amino transferase >99 U/L; aspartate amino transferase > 99 U/L), and thyroid\r\n stimulating hormone > 4.2 uIU/ml), or evidence of current anemia based on blood\r\n chemistry testing.\r\n\r\n - History of adverse events associated with the ingestion of cannabis or any medications\r\n in the Inje cocktail judged by the investigator to present an undue risk of harm to\r\n the participant.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Inje cocktail', 'THC Cannabis extract', 'THC/CBD Cannabis Extract']\n- **Description:** ['Acute drug exposure', 'Acute drug exposure', 'Acute drug exposure']\n- **Mesh Terms:** Dronabinol\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT01810016
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nNY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma\n\n**Trial Summary:** \n\n\n This was a Phase 1, open-label, non-randomized study of the combination of NY-ESO-1 plus\r\n ipilimumab in patients with unresectable or metastatic melanoma for whom treatment with\r\n ipilimumab was indicated. Patients must have had evidence of NY-ESO-1 or LAGE-1 tumor\r\n positivity and radiologically measurable disease by the immune-related Response Criteria\r\n (irRC). Primary study objectives were to determine the safety and tolerability of the\r\n combination and to evaluate humoral and cellular immune response. Secondary objectives were\r\n to evaluate tumor response and immunological changes in the tumor microenvironment.\r\n \n\n**Trial Keywords:** ['NY-ESO-1', 'Metastatic Melanoma', 'Ipilimumab', 'Phase I', 'Adjuvant', 'Immunologic', 'Vaccination', 'Immunotherapy', 'Neoplasm']\n\n**Phase:** Phase 1\n\n**Condition:** Unresectable or Metastatic Melanoma\n\n**Condition Keywords:** Melanoma\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab\r\n was indicated as per ipilimumab/Yervoy® package insert (applicable for United States\r\n [US] sites) or product information (applicable for Australia site).\r\n\r\n 2. Radiologically measurable disease by irRC.\r\n\r\n 3. Tumor expression of NY-ESO-1 or LAGE-1 antigen by immunohistochemistry or reverse\r\n transcriptase-polymerase chain reaction (RT-PCR), or evidence of seropositivity to\r\n NY-ESO-1 or LAGE-1.\r\n\r\n 4. Willingness to provide at least one pre-and post-vaccination tumor biopsy sample.\r\n\r\n 5. Expected survival of at least 4 months.\r\n\r\n 6. At the time of Day 1 of the study, patients must have been at least 3 weeks since\r\n surgery.\r\n\r\n 7. At the time of Day 1 of the study, patients with brain metastases must have been\r\n asymptomatic and:\r\n\r\n - at least 8 weeks without tumor progression after any whole brain radiotherapy;\r\n\r\n - at least 4 weeks since craniotomy and resection or stereotactic radiosurgery;\r\n\r\n - at least 3 weeks without new brain metastases as evidenced by magnetic resonance\r\n imaging (MRI).\r\n\r\n 8. Eastern Cooperative Oncology Group performance status of 0 to 2.\r\n\r\n 9. Laboratory parameters for vital functions must have been in the normal range.\r\n Laboratory abnormalities that were not clinically significant were generally\r\n permitted, except for the following laboratory parameters, which must have been within\r\n the ranges specified:\r\n\r\n - hemoglobin: ≥ 10 g/dL;\r\n\r\n - neutrophil count: ≥ 1.5 x 10^9/L;\r\n\r\n - lymphocyte count: ≥ lower limit of normal (LLN);\r\n\r\n - platelet count: ≥ 80 x 10^9/L;\r\n\r\n - serum creatinine: ≤ 2 mg/dL;\r\n\r\n - serum bilirubin: ≤ 2 x upper limit of normal (ULN);\r\n\r\n - aspartate aminotransferase (AST)/alanine aminotransferase (ALT): ≤ 2 x ULN.\r\n\r\n 10. Had been informed of other treatment options.\r\n\r\n 11. Age ≥ 18 years.\r\n\r\n 12. Able and willing to give valid written informed consent.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Any contraindications for ipilimumab/Yervoy® as per package insert (applicable for US\r\n sites) or product information (applicable for Australia site).\r\n\r\n 2. Prior exposure to NY-ESO-1 vaccine.\r\n\r\n 3. Active autoimmune disease, symptoms or conditions except for vitiligo, type I\r\n diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease\r\n (e.g., +antinuclear antibody [ANA], +rheumatoid factor [RF], antithyroglobulin\r\n antibodies), or mild arthritis requiring no therapy or manageable with nonsteroidal\r\n anti-inflammatory drugs (NSAIDs).\r\n\r\n 4. Unresolved immune-related adverse events following prior biological therapy.\r\n\r\n 5. Systemic treatment with high-dose corticosteroids (greater than prednisone 10 mg daily\r\n or equivalent).\r\n\r\n 6. Treatment with protocol-specified non-permitted concomitant therapies.\r\n\r\n 7. Metastatic disease to the central nervous system for which other therapeutic options,\r\n including radiotherapy, may have been available.\r\n\r\n 8. Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or\r\n transient ischemic attack, chest pain or shortness of breath with activity, or other\r\n heart conditions being treated by a doctor.\r\n\r\n 9. Other malignancy within 3 years prior to entry into the study, except for treated\r\n non-melanoma skin cancer and cervical carcinoma in situ.\r\n\r\n 10. Known immunodeficiency or human immunodeficiency virus positivity, active Hepatitis B\r\n or active Hepatitis C.\r\n\r\n 11. History of severe allergic reactions to vaccines or unknown allergens.\r\n\r\n 12. Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding\r\n disorders).\r\n\r\n 13. Participation in any other clinical trial involving another investigational agent\r\n within 4 weeks prior to Day 1 of the study.\r\n\r\n 14. Mental impairment that may have compromised the ability to give informed consent and\r\n comply with the requirements of the study.\r\n\r\n 15. Lack of availability for immunological and clinical follow-up assessments.\r\n\r\n 16. Women who were breast feeding or pregnant as evidenced by positive serum pregnancy\r\n test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin\r\n [HCG]) done within 14 days prior to first dosing and urine test within 72 hours prior\r\n to first dosing.\r\n\r\n 17. Women of childbearing potential not using a medically acceptable means of\r\n contraception for the duration of the study.\r\n\r\n 18. Any condition that, in the clinical judgment of the treating physician, was likely to\r\n prevent the patient from complying with any aspect of the protocol or that may have\r\n put the patient at unacceptable risk.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Ipilimumab', 'NY-ESO-1 Protein Vaccine', 'NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide', 'NY-ESO-1 OLP4 Vaccine with Poly-ICLC']\n- **Description:** ['Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.', 'NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.', 'NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.', 'NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.']\n- **Mesh Terms:** ['Poly I-C', 'Ipilimumab', 'Carboxymethylcellulose Sodium', 'Vaccines', 'Monatide (IMS 3015)', 'Poly ICLC']\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT04684420
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nGXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study\n\n**Trial Summary:** \n\n\n The purpose of this study was to assess bioequivalence (BE) of newly developed Glucophage® XR\r\n (GXR) reduced mass (RM) tablet (metformin hydrochloride 500 milligrams (mg) test tablet) and\r\n marketed Glucophage ® XR tablet (metformin hydrochloride 500 mg reference tablet) following\r\n single oral dose administration under fasted and fed conditions by comparing\r\n pharmacokinetics, safety and tolerability between test and reference in healthy participants.\r\n \n\n**Trial Keywords:** ['Diabetes Mellitus', 'Glucophage Extended Release', 'Bioequivalence Study']\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 19 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - All values for hematology and biochemistry tests of blood and urinalysis (especially\r\n Estimated Glomerular Filtration Rate [eGFR] greater than [>] 80 milliliters per minute\r\n per 1.73 square meter [80 ml/min/1.73 m^2] and normal Creatinine) within the normal\r\n range or showing no clinically relevant deviation as judged by the Investigator\r\n\r\n - Are not having congenital or chronic diseases, nor pathological symptoms based on the\r\n screening\r\n\r\n - Have no history of gastrointestinal resection that may affect drug absorption\r\n\r\n - Have no history of psychiatric disorder within 5 years prior to screening\r\n\r\n - Vital signs (body temperature [tympanic], blood pressure [BP], and pulse rate in\r\n sitting position) within the normal range or showing no clinically relevant deviation\r\n as judged by the Investigator\r\n\r\n - Electrocardiogram recording (12-lead) without signs of clinically relevant pathology\r\n in particular QTc (Bazett) less than or equal to [<=] 450 millisecond (ms)\r\n\r\n - Non-smoker (that is [i.e.] zero cigarettes, pipes, cigars or others) at least three\r\n months before study entry\r\n\r\n - Negative screen for Hepatitis B surface antigen (HBsAg) and Hepatitis B Virus antibody\r\n (anti-HBc), Hepatitis C Virus antibody (anti-HCV) and Human Immunodeficiency Virus\r\n antibodies (anti-HIV 1 and 2) and Rapid Plasma Reagin Antibody (RPR Ab)\r\n\r\n - Have a body weight within the range 55 to 95 kilograms (kg) and a Body Mass Index\r\n (BMI) within the range 18.5 to 29.9 kilograms per square meter (kg/m^2) (inclusive)\r\n\r\n - Other protocol defined inclusion criteria could apply\r\n\r\n Exclusion Criteria:\r\n\r\n - Participants determined ineligible to participate in this study at the discretion of\r\n the Principal Investigator (or delegated investigators)\r\n\r\n - Hypersensitivity to venous puncture\r\n\r\n - Known hypersensitivity to ingredients of Study Interventions or Biguanides, or having\r\n other clinically relevant hypersensitivities\r\n\r\n - Type I diabetes mellitus, lactic acidosis, acute or chronic metabolic acidosis\r\n including diabetic ketoacidosis, with or without coma; diabetic pre-coma, pre-diabetes\r\n\r\n - Participants with renal impairment (eGFR < 80 ml/min/1.73m^2) - calculations according\r\n to Modification of Diet in Renal Disease (MDRD) formula). Participants presenting with\r\n acute conditions with the potential to alter renal function such as dehydration,\r\n severe infection, cardiovascular collapse (shock), acute myocardial infraction, and\r\n septicemia\r\n\r\n - Participants with acute and unstable heart failure\r\n\r\n - Participants with severe infection or severe traumatic general disorder\r\n\r\n - Participants who are scheduled to undergo surgical procedures\r\n\r\n - Participants with malnutrition, inanition, pituitary dysfunction or adrenal function\r\n failure\r\n\r\n - Participants with hepatic dysfunction, acute or chronic disease which may cause tissue\r\n hypoxia such as respiratory failure, acute myocardial infarction, shock and\r\n gastrointestinal (GI) disorder such as excessive alcohol intake, hydration, diarrhea,\r\n vomiting etc.\r\n\r\n - Participants undergoing intravascular administration of iodinated contrast materials\r\n in radio diagnostic examinations (for example, intravenous urogram, intravenous\r\n cholangiography, angiography, and computed tomography (CT) scans with intravascular\r\n contrast materials etc.)\r\n\r\n - Participants who took drugs that significantly induce (e.g., barbiturate) or inhibit\r\n drug metabolism enzymes, and those drugs that may alter metformin pharmacokinetic\r\n (pK), most importantly organic cation transporter 1/2 [OCT1/2] inhibitors and\r\n inducers, within 30 days prior to screening\r\n\r\n - Use of a concomitant drug. However, any medications that are considered necessary for\r\n participant's welfare and will not interfere with the trial medication may be given at\r\n the discretion of the investigator\r\n\r\n - Use of any medication that may affect the outcome of the study within 10 days prior to\r\n screening and during study conduct\r\n\r\n - Participation in another bioequivalence or other clinical studies where the last\r\n administration of previous study medication was within 6 months, before the first drug\r\n administration in this study\r\n\r\n - Other protocol defined exclusion criteria could apply\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Glucophage® XR RM Test', 'Glucophage® XR Reference']\n- **Description:** ['Participants received a single oral dose of 500 mg of test Glucophage® XR RM tablet under fasting or fed conditions.', 'Participants received a single oral dose of 500 mg of reference Glucophage® XR tablet under fasting or fed conditions.']\n- **Mesh Terms:** Metformin\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02502019
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nHEMOBLAST Pilot Clinical Investigation\n\n**Trial Summary:** \n\n\n The primary objective of this pilot clinical investigation is to assess the reliability of\r\n the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of\r\n this clinical investigation are to collect initial data on the safety and efficacy of\r\n HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Hemostasis\n\n**Condition Keywords:** None\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 21 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - • Subject is undergoing an elective open abdominal or orthopedic lower extremity\r\n surgery;\r\n\r\n - Subject or an authorized legal representative is willing and able to give prior\r\n written informed consent for investigation participation;\r\n\r\n - Subjects on antiplatelets, including aspirin, will discontinue medication at\r\n least 10 days prior to surgery; and\r\n\r\n - Subject is 21 years of age or older.\r\n\r\n - Subject does not have an active or suspected infection at the surgical site;\r\n\r\n - Subject in whom the Investigator is able to identify a target bleeding site (TBS)\r\n for which any applicable conventional means for achieving hemostasis are\r\n ineffective or impractical; and\r\n\r\n - Subject has a TBS with an SBSS score of 1, 2, or 3.\r\n\r\n Exclusion Criteria:\r\n\r\n - • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;\r\n\r\n - Subject is undergoing a spinal surgical procedure;\r\n\r\n - Subject is undergoing a neurologic surgical procedure;\r\n\r\n - Subject is undergoing an emergency surgical procedure;\r\n\r\n - Subject is pregnant, planning on becoming pregnant during the follow-up period,\r\n or actively breast-feeding;\r\n\r\n - Subject has a clinically significant coagulation disorder or disease, defined as\r\n a platelet count < 100,000 per microliter and/or International Normalized Ratio >\r\n 1.5 within 4 weeks of surgery;\r\n\r\n - Subject had chronic corticosteroid use within 2 weeks prior to surgery;\r\n\r\n - Subject receiving intravenous heparin or oral Coumadin within 24 hours of\r\n surgery;\r\n\r\n - Subject has an active or suspected infection at the surgical site;\r\n\r\n - Subject has had or has planned any organ transplantation;\r\n\r\n - Subject has a known sensitivity or allergy to bovine and/or porcine substance(s)\r\n or any other component(s) of the hemostatic agent;\r\n\r\n - Subject has ASA classification of > 4;\r\n\r\n - Subject has a life expectancy of less than 3 months;\r\n\r\n - Subject has a known psychiatric disorder, which in the opinion of the Principal\r\n Investigator, would preclude the subject from completing this clinical study;\r\n\r\n - Subject has a documented severe congenital or acquired immunodeficiency;\r\n\r\n - Subject has religious or other objections to porcine or bovine components;\r\n\r\n - Subject in whom the investigational device will be used at the site of a cemented\r\n or uncemented porous coated joint implant;\r\n\r\n - Subject is currently participating or has participated in another clinical trial\r\n within the past 30 days and is receiving/has received an investigational drug,\r\n device, or biologic agent; and\r\n\r\n - Subject is not appropriate for inclusion in the clinical trial, per the medical\r\n opinion of the Principal Investigator.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** HEMOBLAST Bellows\n- **Description:** HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03131167
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nStudy of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma\n\n**Trial Summary:** \n\n\n Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the\r\n investigational SHP639 eye drops will be evaluated in participants with high eye pressure or\r\n primary open-angle glaucoma.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Primary Open-angle Glaucoma (POAG)', 'Ocular Hypertension']\n\n**Condition Keywords:** ['Glaucoma', 'Glaucoma, Open-Angle', 'Ocular Hypertension', 'Hypertension']\n\n**ICD Code:** [\"['H40.053', 'H40.051', 'H40.052', 'H40.059']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 90 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Participants must provide written, signed and dated informed consent to participate in\r\n the study in accordance with the International Council for Harmonisation (ICH) Good\r\n Clinical Practice (GCP) Guideline E6(R1) and applicable regulations, before completing\r\n any study-related procedures.\r\n\r\n 2. Participants must be aged from 18 through 90 at the time of consent. This inclusion\r\n criterion will only be assessed at the screening visit.\r\n\r\n 3. Participants must have ocular hypertension (OHT) or stable early primary open-angle\r\n glaucoma (POAG) in both eyes with acceptable Humphrey visual fields (HVF). Early POAG\r\n for this protocol is defined as healthy appearing anterior chamber angles (Shaffer\r\n classification system grade 3 or 4) and focal and/or generalized thinning of the optic\r\n disc rim characteristic of glaucomatous disease. An acceptable HVF must have been\r\n performed within approximately one year of screening, have a false-positive rate of 25\r\n percent (%) maximum, false-negative rate of 25% maximum, and fixation loss rate of 33%\r\n maximum, and mean deviation of no worse than -6.00 decibels (dB).\r\n\r\n 4. On Day -1, participants must have a mean IOP of greater than or equal to (>=) 24\r\n millimeter of mercury (mmHg) at 8:00 AM and a mean IOP of >= 22 mmHg at 10:00 AM in at\r\n least 1 eye, with an IOP difference of less than (<) 4 mmHg between eyes at both of\r\n these time points. If only 1 eye meets this criterion, then it will be the designated\r\n study eye for pharmacodynamic analysis; this eye will also be used for dosing in\r\n Cohort A single-dose treatment period (SDTP).\r\n\r\n 5. Participants must have a best-corrected visual acuity (BCVA) in both eyes of 65\r\n letters on the Early Treatment Diabetic Retinopathy Study chart (Snellen equivalent\r\n approximately [∼] 20/60) or better at the screening and baseline assessments.\r\n\r\n 6. Participants must be males or females who are non-pregnant and non-lactating at\r\n screening (negative serum beta-human chorionic gonadotropin [beta-hCG]); if sexually\r\n active during the study, they must agree to comply with the applicable contraceptive\r\n requirements throughout the study period and for 60 days following the last dose of\r\n investigational product.\r\n\r\n 7. Participants must have a satisfactory medical assessment with no clinically\r\n significant or relevant abnormalities as determined by medical history, physical\r\n examination, and clinical and laboratory evaluation (hematology, biochemistry,\r\n urinalysis) as assessed by the investigator.\r\n\r\n 8. Participants must understand and be able, willing, and likely to fully comply with\r\n study procedures and restrictions.\r\n\r\n 9. Participants must be non-smokers or have had stable use of tobacco or\r\n nicotine-containing products for a 3-month period before signing the informed consent\r\n form (ICF).\r\n\r\n 10. Participants who drink alcohol must have had stable use of alcohol for a 3-month\r\n period before signing the ICF.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Participant has an anatomically narrow angle, synechiae or evidence of prior\r\n inflammation, angle closure glaucoma, normal tension glaucoma, pseudoexfoliation\r\n syndrome or pigmentary dispersion syndrome with or without glaucoma, or secondary\r\n glaucoma.\r\n\r\n 2. Participant has corneal endothelial cell counts of less than 2000 cells per\r\n millimeter^2 (measured by noncontact specular microscopy) at the screening or baseline\r\n assessments.\r\n\r\n 3. Participant has central corneal thickness less than 500 micrometer (mcm) or greater\r\n than 620 mcm at the screening or baseline assessments.\r\n\r\n 4. Participant has IOP greater than 32 mmHg in either eye before randomization.\r\n\r\n 5. Participant has used topical ocular hypotensive medications as follows: prostaglandin\r\n analogs, beta-adrenoceptor antagonists, alpha-adrenergic agonists, or\r\n epinephrine-related medications within 4 weeks before the first dose of\r\n investigational product; or pilocarpine or carbonic anhydrase inhibitors within 7 days\r\n before the first dose of investigational product.\r\n\r\n 6. Participant has a history of angle closure, ocular surgery, microinvasive glaucoma\r\n surgery device insertion, or laser surgery, except for the following procedures, which\r\n are allowed: uncomplicated cataract surgery, laser peripheral iridotomy with resultant\r\n angle of Shaffer grade 3 or 4, and postcataract neodymium-doped\r\n yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy. Cataract surgery and\r\n other procedures must have occurred a minimum of 3 months before randomization.\r\n\r\n 7. Participant has a history of significant ocular trauma or ocular disease including but\r\n not limited to moderate to severe dry eye disease that requires chronic treatment or\r\n punctal plugs.\r\n\r\n 8. Participant has evidence of ocular infection, inflammation, degeneration, or dystrophy\r\n at the screening or baseline assessments, including but not limited to moderate to\r\n severe blepharitis (mild blepharitis is allowed), conjunctivitis (allergic or\r\n infectious), corneal dystrophy (epithelial, stromal, or endothelial), corneal haze of\r\n grade 1 or greater based on the Hwang Grading Scale of Corneal Haze, corneal\r\n opacities, keratitis, uveitis, or vitritis.\r\n\r\n 9. Participant has retinal disease including but not limited to: moderate or severe\r\n non-proliferative diabetic retinopathy (NPDR) (early NPDR is allowed), proliferative\r\n diabetic retinopathy, intermediate or advanced dry age-related macular degeneration\r\n (AMD) (early dry AMD is allowed), all geographic atrophy, or all wet AMD.\r\n\r\n 10. Participant has any non-glaucomatous optic neuropathy or other significant\r\n non-glaucomatous ocular disease that is likely to affect visual function.\r\n\r\n 11. Participant has any corneal or ocular surface pathology in either eye that prevents\r\n proper IOP measurement, pachymetry, or other study data collection procedures.\r\n\r\n 12. Participant has had changes to their existing prescription medication regimen for\r\n chronic disease, including those medicines that affect IOP, within 14 days or 5\r\n half-lives before screening, whichever is longer.\r\n\r\n 13. Participant has started any new prescription drug medication for chronic disease,\r\n including those medicines that affect IOP, within 14 days or 5 half-lives before\r\n screening, whichever is longer.\r\n\r\n 14. Participant has a history of corticosteroid use within 3 months before randomization,\r\n except for non-periocular dermatologic use, which is allowed.\r\n\r\n 15. Participant has used belladonna alkaloids (scopolamine, hyoscamine, atropine) within 7\r\n days prior to randomization, cannabinoids or opioids within 28 days before\r\n randomization, or B-type natriuretic peptides within the past year before\r\n randomization; or a participant has an anticipated need for any of the aforementioned\r\n drugs/drug categories during the study.\r\n\r\n 16. Participant has used amantadine within 28 days before randomization.\r\n\r\n 17. Participant is unable to discontinue contact lens use during and for 60 minutes\r\n following instillation of study medication, during ophthalmologic examinations, and\r\n during study visits.\r\n\r\n 18. Participant has a current or relevant history of any physical, medical, mental, or\r\n psychiatric illness, disorder, or condition that may require treatment during the\r\n study and/or that may interfere with the participant complying with the study rules\r\n and procedures or completing the study.\r\n\r\n 19. Participant has any condition that presents undue risk from use of the investigational\r\n product, assessment tools, or procedures.\r\n\r\n 20. Participant is a woman who is pregnant (positive serum beta-hCG pregnancy test at the\r\n time of screening), lactating, or less than 90 days post-partum at randomization.\r\n\r\n 21. Participant has donated blood within 60 days before first dose of investigational\r\n product.\r\n\r\n 22. Participant has donated plasma within 28 days before first dose of investigational\r\n product.\r\n\r\n 23. Participant has used another investigational product within 30 days before the first\r\n dose of investigational product or is actively enrolled in a drug or vaccine clinical\r\n study.\r\n\r\n 24. Participant has a positive human immunodeficiency virus (HIV), hepatitis B surface\r\n antigen (HBsAg), or hepatitis C virus (HCV) antibodies screen.\r\n\r\n 25. Participant has a positive drugs of abuse screen or alcohol breathalyzer test.\r\n\r\n 26. Participant has been previously enrolled in this study.\r\n\r\n 27. Participant has known hypersensitivity or allergy to any of the ingredients of the\r\n investigational product.\r\n\r\n 28. Participant consumes more than 21 units of alcohol per week or is unable to refrain\r\n from alcohol consumption within 48 hours before a scheduled visit. (1 alcohol unit=1\r\n beer or 1 wine [5 ounce per 150 milliliter] or 1 liquor [1.5 ounce per 40 milliliter]\r\n or 0.75 ounce alcohol.)\r\n\r\n 29. Participant is unable to refrain from tobacco or any products containing nicotine\r\n within 8 hours before a scheduled visit.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['SHP639 (n=60)', 'Placebo Comparator (n=24)']\n- **Description:** ['Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog.', 'Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT05188261
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of Single Ascending Doses of IW-3300 in Healthy Volunteers\n\n**Trial Summary:** \n\n\n This is a first-in-human study to evaluate the safety and tolerability of single ascending\r\n doses of IW-3300. The study drug will be administered rectally as a low-volume (20 mL) enema.\r\n Study participants will be randomized in a 3:1 ratio to receive a single dose of IW-3300 or\r\n placebo. Up to 5 different doses of IW-3300 will be studied. Safety reviews will be conducted\r\n before proceeding to each higher dose.\r\n \n\n**Trial Keywords:** healthy volunteers\n\n**Phase:** Phase 1\n\n**Condition:** Healthy Volunteers\n\n**Condition Keywords:** None\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 60 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Males and female subjects of non-childbearing potential\r\n\r\n 2. Ages 18 to 60 years\r\n\r\n 3. Medically healthy with no clinically significant findings during medical evaluation\r\n including physical examination, 12-lead electrocardiogram (ECG), and clinical\r\n laboratory tests.\r\n\r\n 4. Normal bowel movement frequency of formed stool at baseline (≥3 per week and ≤3 per\r\n day; average Bristol stool form scale (BSFS) score of >2 and <6).\r\n\r\n 5. Body mass index (BMI) within the range 18.5 to 35.0 kg/m2 (inclusive) at the Screening\r\n Visit.\r\n\r\n 6. Male subjects and female partners are willing to use double-barrier method of\r\n contraception during the study.\r\n\r\n 7. If subject is ≥45 years of age, subject is compliant with colorectal cancer screening\r\n guidelines according to the American College of Gastroenterology (ACG) Clinical\r\n Guidelines: Colorectal Cancer Screening 2021.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Evidence or history of clinically significant acute or chronic disease, or clinically\r\n significant illness within 30 days of the Screening Visit.\r\n\r\n 2. History of clinically significant hypersensitivity or allergies to any of the inactive\r\n ingredients contained in the active or placebo drug products.\r\n\r\n 3. History of any condition that would interfere with their ability to receive an enema,\r\n or has had difficulty receiving an enema in the past.\r\n\r\n 4. Recent history of anal fissure, anal abscess, complicated hemorrhoids, or presence or\r\n history of inflammatory bowel disease.\r\n\r\n 5. Used a prescription medication during the 14 days before Check-in\r\n\r\n 6. Used any over-the-counter medications, including laxatives, and herbal supplements\r\n during the 7 days before Check-in.\r\n\r\n 7. Received a licensed or investigational vaccine during the 30 days before Check-in or\r\n is planning to receive any vaccine during the study.\r\n\r\n 8. Recently received or donated blood products.\r\n\r\n 9. Undergone a surgical procedure during the 30 days before Check-in, other than minor\r\n dermatologic procedures, or has a history of surgery involving the GI tract or anal\r\n canal (with the exception of endoscopic procedures, appendectomy, and\r\n cholecystectomy).\r\n\r\n 10. Received any investigational drug during the 30 days or 5 half-lives of that\r\n investigational drug (whichever is longer) before the Screening Visit, or is planning\r\n to receive another investigational drug at any time during the study.\r\n\r\n 11. Abnormal laboratory tests or clinically significant findings on safety tests conducted\r\n at the Screening Visit or at Check-in.\r\n\r\n 12. Confirmed or suspected infection with COVID-19 at the Screening Visit or Check-in.\r\n\r\n 13. Positive serology for human immunodeficiency virus (HIV) 1, HIV 2, or hepatitis B\r\n surface antigen (HBsAg), or positive for anti-HIV 1, anti-HIV 2, or anti hepatitis C\r\n virus (HCV) antibodies at the Screening Visit.\r\n\r\n 14. History of alcohol or drug addiction during the year before the Screening Visit, or\r\n has a positive drug or alcohol screen at the Screening Visit or Check-in.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['IW-3300', 'Placebo']\n- **Description:** ['A single dose of IW-3300 administered rectally (as a low-volume [20 mL] enema) following a fast of at least 6 hours.', 'A single dose of placebo administered rectally (as a low-volume [20 mL] enema) following a fast of at least 6 hours.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02528357
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nGSK3174998 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors (ENGAGE-1)\n\n**Trial Summary:** \n\n\n This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed\r\n to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and\r\n preliminary clinical activity of GSK3174998 administered intravenously to participants with\r\n selected advanced or recurrent solid tumors. This dose-escalation study will assess the\r\n safety, activity of GSK3174998 as monotherapy (Part 1), in combination with pembrolizumab\r\n (Part 2), and potentially in combination with additional therapies.\r\n\r\n The study will be conducted in 2 parts, each part consisting of starting with a\r\n dose-escalation phase followed by a cohort expansion phase. GSK3174998 will first be\r\n evaluated as monotherapy in escalating doses. Once a dose of GSK3174998 has been identified\r\n that is both tolerable and demonstrates pharmacodynamic activity, enrollment of Part 2 may\r\n begin. In Part 2, escalating doses of GSK3174998 will be evaluated with fixed doses of\r\n pembrolizumab.\r\n\r\n The maximum duration of treatment with GSK3174998 and pembrolizumab will be approximately 2\r\n years or 35 cycles, whichever comes first. The follow-up period for safety assessments will\r\n be a minimum of 3 months from the date of the last dose. The post-treatment follow-up period\r\n will include disease assessments every 12 weeks until documented progressive disease (PD).\r\n Approximately 141 participants with selected advanced or recurrent solid tumors will be\r\n enrolled.\r\n \n\n**Trial Keywords:** ['GSK3174998', 'Non-small Cell Lung Cancer (NSCLC)', 'OX40', 'Pembrolizumab', 'Monoclonal Antibody (mAb)', 'Selected Advanced Solid Tumors']\n\n**Phase:** Phase 1\n\n**Condition:** Neoplasms\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Provide signed, written informed consent.\r\n\r\n - Male and female participants, age >=18 years (at the time consent is obtained).\r\n\r\n - Histological documentation of locally advanced, recurrent or metastatic solid\r\n malignancy that has progressed after standard therapy appropriate for the specific\r\n tumor type, or for which standard therapy has proven to be ineffective, intolerable,\r\n or is considered inappropriate. Participants should not have received more than 5\r\n prior lines of therapy for advanced disease including both standards of care and\r\n investigational therapies. Participants whose cancers harbor molecular alterations for\r\n which targeted therapy is standard of care should have received health authority\r\n approved appropriate targeted therapy for their tumor types before enrollment.\r\n\r\n - Participants with the following solid tumors are eligible for screening: Non-small\r\n cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (SCCHN), Renal\r\n cell carcinoma (RCC), melanoma, bladder, Soft Tissue Sarcoma (STS), Triple-negative\r\n breast cancer (TNBC), and Colorectal carcinoma displaying high microsatellite\r\n instability (MSI CRC). In Part 2B (Cohort Expansion), specific subgroups of the above\r\n solid tumors will be studied. These subgroups may be defined by specific lines of\r\n treatment, types of prior treatment, histological subtypes, and may be enriched for\r\n selected biomarkers or participant characteristics. Populations to be studied in\r\n Amendment 3 include but are not limited to the following. Enrolment of additional\r\n populations will be communicated in writing: Participants with dedifferentiated\r\n liposarcoma who have not received prior treatment with a Programmed death ligand 1\r\n (PD-L1) inhibitor; Participants with melanoma who have received a prior PD-L1\r\n inhibitor, had a CR, PR or SD and subsequently progressed while on PD-L1 therapy.\r\n Participants who have received prior treatment with a PD-L1 inhibitor must have\r\n documented disease progression as defined by meeting all of the following criteria:\r\n Has received at least 2 doses of an approved PD-L1 inhibitor; has demonstrated disease\r\n progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST)\r\n version 1.1. The initial evidence of disease progression is to be confirmed by a\r\n second assessment no less than four weeks from the date of the first documented PD ,\r\n in the absence of rapid clinical progression; Progressive disease has been documented\r\n within 18 weeks from the last dose of the PD-L1 inhibitor.\r\n\r\n - In Parts 1A and 2A, a biopsy of the tumor tissue obtained at anytime from the initial\r\n diagnosis to study entry. Although a fresh biopsy obtained during screening is\r\n preferred, archival tumor specimen is acceptable if it is not feasible to obtain a\r\n fresh biopsy.\r\n\r\n Participants enrolled in Part 1A or Part 2A Pharmacodynamic Cohorts or in Part 2B of the\r\n study must provide a fresh biopsy of a tumor lesion not previously irradiated during the\r\n screening period and must agree to provide at least one additional on-treatment biopsy. In\r\n addition, an archived tumor tissue should be submitted for Participants in Part 2B, if\r\n available. The criterion for collection of fresh biopsies may be waived once\r\n GlaxoSmithKline (GSK)has determined an appropriate number of viable tissue samples have\r\n been analyzed For Part 1B and Part 2B, any archival tumor specimen must have been obtained\r\n within 3 months of starting study drug.\r\n\r\n - Measurable disease as per RECIST v1.1\r\n\r\n - Palpable lesions that are not measurable by radiologic or photographic evaluations may\r\n not be utilized as the only measurable lesion.\r\n\r\n - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\r\n\r\n - Life expectancy of at least 12 weeks.\r\n\r\n - Adequate organ function as defined by System Laboratory Values; Hematologic (Absolute\r\n neutrophil count [ANC] >=1.5x10^9/ liter [L], Lymphocyte count >=800/cubic millimeter\r\n [mm^3], Hemoglobin >=9 grams/deciliter [g/dL], Platelets >=100x10^9/L), Hepatic (Total\r\n bilirubin <=1.5x upper limit of normal [ULN] [For participants with Gilbert's\r\n Syndrome, only if direct bilirubin <=35 percent (%), <=3.0xULN], for Part 1A and 2A:\r\n alanine aminotransferase [ALT] <=1.5xULN), Part 2B: ALT <=2.5xULN; Renal (Serum\r\n Creatinine <=1.5xULN OR Calculated creatinine clearance [CrCl >50 mL/min ) and\r\n Endocrine (Thyroid stimulating hormone [TSH]) within normal limits. If TSH is not\r\n within normal limits at baseline, the participant may still be eligible if total\r\n triiodothyronine (T3) or free T3 and free thyroxine (T4) are within the normal limits.\r\n\r\n - QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 milliseconds\r\n (msec) or <480 msec for participants with bundle branch block.\r\n\r\n - In France, a participant will be eligible for inclusion in this study only if either\r\n affiliated to or a beneficiary of a social security category.\r\n\r\n - Female participant: is eligible to participate if she is not pregnant (as confirmed by\r\n a negative serum beta-human chorionic gonadotrophin [beta-hCG] test), not lactating,\r\n and at least one of the following conditions applies: Non-reproductive potential\r\n defined as: Pre-menopausal females with one of the following: Documented tubal\r\n ligation; Documented hysteroscopic tubal occlusion procedure with follow-up\r\n confirmation of bilateral tubal occlusion ; Hysterectomy; Documented Bilateral\r\n Oophorectomy.\r\n\r\n Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a\r\n blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels\r\n consistent with menopause). Females on hormone replacement therapy (HRT) and whose\r\n menopausal status is in doubt will be required to use one of the highly effective\r\n contraception methods if they wish to continue their HRT during the study. Otherwise, they\r\n must discontinue HRT to allow confirmation of post-menopausal status prior to study\r\n enrolment.\r\n\r\n - Reproductive potential and agrees to follow one of the options listed below in the GSK\r\n Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of\r\n Reproductive Potential (FRP) requirements from 30 days prior to the first dose of\r\n study medication and until 120 days after the last dose of study medication and\r\n completion of the follow-up visit. GSK Modified List of Highly Effective Methods for\r\n Avoiding Pregnancy in Females of Reproductive Potential (FRP).\r\n\r\n This list does not apply to FRP with same sex partners, when this is their preferred and\r\n usual lifestyle or for participants who are and will continue to be abstinent from\r\n penile-vaginal intercourse on a long term and persistent basis: Contraceptive subdermal\r\n implant with a <1% rate of failure per year, as stated in the product label; Intrauterine\r\n device or intrauterine system with a <1% rate of failure per year, as stated in the product\r\n label; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen;\r\n Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner sterilization\r\n with documentation of azoospermia prior to the female participant's entry into the study,\r\n and this male is the sole partner for that participant. These allowed methods of\r\n contraception are only effective when used consistently, correctly and in accordance with\r\n the product label. The investigator is responsible for ensuring that participants\r\n understand how to properly use these methods of contraception.\r\n\r\n - Male Participants with female partners of child bearing potential must comply with the\r\n following contraception requirements from the time of first dose of study medication\r\n until 120 days after the last dose of study medication: Vasectomy with documentation\r\n of azoospermia; Male condom plus partner use of one of the contraceptive options\r\n below; Contraceptive subdermal implant with a <1% rate of failure per year, as stated\r\n in the product label; Intrauterine device or intrauterine system with a <1% rate of\r\n failure per year, as stated in the product label; Oral Contraceptive, either combined\r\n or progestogen alone Injectable progestogen; Contraceptive vaginal ring; Percutaneous\r\n contraceptive patches.\r\n\r\n These allowed methods of contraception are only effective when used consistently, correctly\r\n and in accordance with the product label. The investigator is responsible for ensuring that\r\n participants understand how to properly use these methods of contraception.\r\n\r\n Exclusion Criteria:\r\n\r\n - Prior treatment with the following agents (from last dose of prior treatment to first\r\n dose of GSK3174998): Tumor necrosis factor receptor (TNFR) agonists, including OX40,\r\n CD27, CD137 (4-1BB), CD357 (GITR): at any time; Checkpoint inhibitors, including\r\n Programmed death receptor-1 (PD-1),\r\n\r\n 1, and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors: within 4\r\n weeks; other anticancer therapy, including chemotherapy, targeted therapy, and\r\n biological therapy: within 4 weeks or 5 half lives of the drug, whichever is shorter.\r\n Prior radiation therapy is permissible if at least one unirradiated measurable lesion\r\n is available for assessment via RECIST version 1.1. A wash out of at least two weeks\r\n before start of study drug for palliative radiation to the extremities for osseous\r\n bone metastases and 4 weeks for radiation to the chest, brain, or visceral organs is\r\n required; Investigational therapy: if the participant has participated in a clinical\r\n trial and has received an investigational product: within 30 days or 5 half-lives of\r\n the investigational product (whichever is shorter). At least 14 days must have passed\r\n between the last dose of prior investigational agent and the first dose of study drug.\r\n\r\n - Prior allogeneic or autologous bone marrow transplantation or other solid organ\r\n transplantation.\r\n\r\n - Toxicity from previous treatment: Participants with >=Grade 3 toxicity related to\r\n prior immunotherapy leading to study treatment discontinuation are not eligible;\r\n participants whose toxicity related to prior treatment has not resolved to <=Grade 1\r\n (except alopecia, hearing loss, grade <=2 neuropathy or endocrinopathy managed with\r\n replacement therapy) are not eligible.\r\n\r\n - Malignancy other than disease under study, except as noted below: any other malignancy\r\n from which the participant has been disease-free for more than 2 years and, in the\r\n opinion of the principal investigators and GSK Medical Monitor, will not affect the\r\n evaluation of the effects of this clinical trial treatment on currently targeted\r\n malignancy, can be included in this clinical trial.\r\n\r\n - Central nervous system (CNS) metastases, with the following exception: Participants\r\n who have previously-treated CNS metastases, are asymptomatic, and have had no\r\n requirement for steroids for 2 weeks prior to first dose of study drug.\r\n\r\n - Has received transfusion of blood products (including platelets or red blood cells) or\r\n administration of colony stimulating factors (including granulocyte colony stimulating\r\n factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GMCSF], recombinant\r\n erythropoietin) within 2 weeks before the first dose of study drug.\r\n\r\n - Major surgery <=4 weeks before the first dose of study treatment. Participants must\r\n have also fully recovered from any surgery (major or minor) and/or its complications\r\n before initiating study treatment.\r\n\r\n - Active autoimmune disease that has required systemic treatment within the last 2 years\r\n (that is with use of disease modifying agents, corticosteroids or immunosuppressive\r\n drugs). Replacement therapy (example [e.g.], thyroxine or physiologic corticosteroid\r\n replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r\n form of systemic treatment.\r\n\r\n - Concurrent medical condition requiring the use of systemic immunosuppressive\r\n medications within 28 days before the first dose of study treatment. Physiologic doses\r\n of corticosteroids for treatment of endocrinopathies or steroids with minimal systemic\r\n absorption, including topical, inhaled, or intranasal corticosteroids may be continued\r\n if the participant is on a stable dose.\r\n\r\n - Active infection, known human immunodeficiency virus infection, or positive test for\r\n hepatitis B surface antigen or hepatitis C.\r\n\r\n - Current active liver or biliary disease (with the exception of Gilbert's syndrome or\r\n asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease\r\n per investigator assessment).\r\n\r\n - Known, current drug or alcohol abuse.\r\n\r\n - Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel\r\n disease, intra-abdominal abscess, or gastrointestinal obstruction.\r\n\r\n - Receipt of any live vaccine within 4 weeks.\r\n\r\n - Recent history of allergen desensitization therapy within 4 weeks of starting study\r\n Treatment.\r\n\r\n - History of severe hypersensitivity to other mAbs.\r\n\r\n - History or evidence of cardiovascular risk including any of the following: Recent\r\n (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or\r\n clinically significant ECG abnormalities including second degree (Type II) or third\r\n degree atrioventricular block; Documented cardiomyopathy, myocardial infarction, acute\r\n coronary syndromes (including unstable angina pectoris), coronary angioplasty,\r\n stenting, or bypass grafting within the past 6 months before enrollment; documented\r\n congestive heart failure (Class II, III, or IV) as defined by the New York Heart\r\n Association functional classification system; recent (within the past 6 months)\r\n history of symptomatic pericarditis Current or history of idiopathic pulmonary\r\n fibrosis, interstitial lung disease, or organizing pneumonia.\r\n\r\n - History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\r\n\r\n - Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural\r\n effusions.\r\n\r\n - Any serious and/or unstable pre-existing medical, psychiatric disorder, or other\r\n condition that could interfere with the participant's safety, obtaining informed\r\n consent, or compliance to the study procedures.\r\n\r\n - Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or\r\n child) who is investigational site or sponsor staff directly involved with this trial,\r\n unless prospective Institutional Review Board (IRB) approval (by chair or designee) is\r\n given allowing exception to this criterion for a specific participant.\r\n\r\n - History of severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its\r\n excipients.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['GSK3174998', 'Pembrolizumab']\n- **Description:** ['Lyophilized powder 40 mg reconstituted to get a dose range of 0.003 to <=10 mg/kg to be given as IV infusion for 30 minutes (min), Q3W', 'Pembrolizumab as 100 mg/4 milliliter (mL) solution (dose: 200 mg) to be given as IV infusion for 30 min, Q3W']\n- **Mesh Terms:** Pembrolizumab\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
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NCT04228302
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety, Tolerability, and Pharmacokinetics of Oral EC5026 in Healthy Subjects\n\n**Trial Summary:** \n\n\n This is a first-in-human study with EC5026, a new drug candidate intended to treat\r\n neuropathic pain. The purpose of the study is to provide initial safety, tolerability, and\r\n pharmacokinetics data of single ascending oral doses of EC5026 in healthy subjects.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy Adults\n\n**Condition Keywords:** None\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n Each subject must meet all of the following criteria to be enrolled in this study:\r\n\r\n 1. The subject is male of female 18 to 65 years, inclusive\r\n\r\n 2. The subject is able and willing to provide written informed consent to participate in\r\n the study.\r\n\r\n 3. The subject is considered by the investigator to be in good general health as\r\n determined by prestudy medical history, physical examination findings, clinical\r\n laboratory test results, and 12-lead electrocardiogram (ECG) results.\r\n\r\n 4. The subject is willing and able to remain in confinement at the study unit from Day -1\r\n to Day 5 and return to the unit at Days 7 and 14 for additional blood tests and safety\r\n evaluations.\r\n\r\n 5. The subject has a body mass index of 19.0 to 32.0 kg/m2, inclusive, at Screening.\r\n\r\n 6. The subject has normal blood pressure (systolic blood pressure 90 to 140 mm Hg,\r\n diastolic blood pressure 50 to 90 mm Hg), and heart rate (resting heart rate 45 to 90\r\n beats per minute) without medication.\r\n\r\n 7. The subject has a clinical chemistry profile including electrolytes, alkaline\r\n phosphatase (ALP), lactate dehydrogenase, creatine phosphokinase (CPK), creatinine,\r\n and urea within the normal range without medication at Screening.\r\n\r\n 8. The subject has urinalysis results including urinary creatinine within the normal\r\n range.\r\n\r\n 9. The subject is a nonsmoker or is willing to abstain from smoking starting 2 weeks\r\n prior to randomization and for the duration of the study.\r\n\r\n 10. The subject is able to read, understand, and follow the study instructions.\r\n\r\n 11. Male subjects and their female partners must agree to use double-barrier contraception\r\n during the study and for 2 months after receiving the last dose of study drug or\r\n provide proof of postmenopausal state (minimum 1 year) or surgical sterility.\r\n\r\n 12. Male subjects must not donate sperm during the study and for 12 months after receiving\r\n the last dose of study drug.\r\n\r\n 13. Female subjects must be nonpregnant, nonlactating, and either postmenopausal for at\r\n least 1 year, or surgically sterile for at least 3 months, or agrees to use double\r\n barrier contraception from 28 days prior to randomization and/or their last confirmed\r\n menstrual period prior to study randomization (whichever is longer) until 2 months\r\n after discharge from the clinic. Female subjects will refrain from using hormonal\r\n contraceptives for at least 28 days prior to study entry until the end of study (EOS)\r\n visit (Day 14). All female subjects of childbearing potential must have a negative\r\n pregnancy test result at Screening and baseline (Day -1).\r\n\r\n Exclusion Criteria:\r\n\r\n Subjects meeting any of the following criteria will be excluded from the study:\r\n\r\n 1. The subject has any abnormalities in any of the following: liver function tests, CPK,\r\n or urinalysis results. Liver function tests, CPK, or urinalysis tests may be repeated\r\n at the discretion of the investigator, if necessary, to confirm any abnormalities.\r\n\r\n 2. The subject has used any nonstudy medication(s), including low-dose aspirin for\r\n cardiovascular prophylaxis, within 1 week before administration of study drug.\r\n\r\n 3. The subject has used chemotherapy agents or has a history of cancer, other than\r\n nonmetastatic skin cancer that has been completely excised, within 5 years prior to\r\n screening.\r\n\r\n 4. The subject has a history of bacterial, fungal, or viral infection requiring treatment\r\n with antibiotics, antifungal agents, or antivirals within 1 month prior to\r\n randomization.\r\n\r\n 5. The subject has a presence or history of peripheral edema within the past 5 years.\r\n\r\n 6. The subject has a history of congestive heart failure.\r\n\r\n 7. The subject has used drugs which are CYP inducers or inhibitors within 30 days of\r\n randomization (eg, cimetidine, paroxetine, fluoxetine, haloperidol, ketoconazole,\r\n itraconazole, fluconazole, erythromycin, clarithromycin).\r\n\r\n 8. The subject has used any dietary aids, supplements, or foods that are known to\r\n modulate drug metabolizing enzymes (eg, St. John's wort, grapefruit juice) within 14\r\n days of administration of study drug.\r\n\r\n 9. The subject has difficulty in swallowing oral medications.\r\n\r\n 10. The subject has a history of seizure disorder.\r\n\r\n 11. The subject has serious psychosocial comorbidities as determined by the principal\r\n investigator.\r\n\r\n 12. The subject has cognitive or psychiatric disorders, or any other condition that could\r\n interfere with compliance with study procedures and/or confinement in a study unit for\r\n 5.5 days.\r\n\r\n 13. The subject has a history of drug or alcohol abuse within 1 year prior to Screening.\r\n\r\n 14. The subject has used any other investigational drug within 1 month or 5 half-lives,\r\n whichever is longer, prior to randomization.\r\n\r\n 15. The subject has used prescription drugs within 1 month or 5 half-lives, whichever is\r\n longer, prior to randomization.\r\n\r\n 16. The subject has used over-the-counter medication excluding routine vitamins, but\r\n including mega-dose vitamin therapy, within 1 week prior to randomization.\r\n\r\n 17. The subject has donated and/or received any blood or blood products (more than 450 mL)\r\n within 3 months prior to randomization.\r\n\r\n 18. The subject has a presence or history of active gastrointestinal, renal, hepatic, or\r\n coagulant disorder within 1 month prior to randomization.\r\n\r\n 19. The subject has a presence or history of esophageal or gastroduodenal ulceration\r\n within 1 month prior to randomization.\r\n\r\n 20. The subject has a family history of significant cardiac disease (ie, sudden death in\r\n first degree relative; myocardial infarction prior to 50 years\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['EC5026 oral capsule', 'Placebo oral capsule']\n- **Description:** ['5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort).\\r\\nOral doses of EC5026 tested in each cohort: 0.5 mg (Cohort 1), 2 mg (Cohort 2), 8 mg (Cohort 3), 16 mg (Cohort 4), and 24 mg (Cohort 5).\\r\\nA blinded sentinel group of 2 subjects (1 active and 1 placebo) will be dosed at least 2 days before the remaining 6 subjects (5 active and 1 placebo) will receive blinded doses of active study drug or placebo.', '5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort)']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
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NCT03272464
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nINCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.\n\n**Trial Summary:** \n\n\n This research study is studying a combination of drugs as a possible treatment for\r\n BRAF-mutant melanoma.\r\n\r\n The drugs involved in this study are:\r\n\r\n - Itacitinib (INCB039110)\r\n\r\n - Dabrafenib\r\n\r\n - Trametinib\r\n \n\n**Trial Keywords:** Melanoma\n\n**Phase:** Phase 1\n\n**Condition:** Melanoma\n\n**Condition Keywords:** Melanoma\n\n**ICD Code:** [\"['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - For Dose-Escalation Phase: Patients must have histologically confirmed, BRAF-mutant\r\n (V600E/K) malignancy (molecularly confirmed using Cobas assay or a comparable\r\n FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable,\r\n have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted)\r\n therapy or not previously received BRAF targeted therapy, and for which standard\r\n curative or palliative measures do not exist or are no longer effective.\r\n\r\n - If test at CLIA-certified lab used a non-FDA approved method, information about the\r\n assay must be provided to the Overall Principal Investigator (PI) for approval. (FDA\r\n approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit\r\n and Cobas 4800 BRAF V600 Mutation Test).\r\n\r\n - For Dose-Expansion Phase: Patients must have histologically confirmed, BRAF-mutant\r\n (V600E/K) melanoma (molecularly confirmed using Cobas assay or a comparable\r\n FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable,\r\n have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted)\r\n therapy at full dose or not previously received BRAF targeted therapy.\r\n\r\n - If test at CLIA-certified lab used a non-FDA approved method, information about the\r\n assay must be provided to the Overall Principal Investigator (PI) for approval. (FDA\r\n approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit\r\n and Cobas 4800 BRAF V600 Mutation Test).\r\n\r\n - Patients must have measurable disease by RECIST, defined as at least one lesion that\r\n can be accurately measured in at least one dimension (longest diameter to be recorded\r\n for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional\r\n techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See\r\n Section 11 for the evaluation of measurable disease.\r\n\r\n - Patients may have received any number of prior lines of therapy. All prior systemic\r\n anti-cancer treatment-related toxicities must be less than or equal to Grade 1\r\n according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE\r\n version 4.0; NCI, 2009) at the time of enrollment. This does not include alopecia and\r\n Grade 2 or less peripheral neuropathy.\r\n\r\n - Age ≥18 years. Because no dosing or adverse event data are currently available on the\r\n use of INCB039110 in combination with dabrafenib and trametinib in patients <18 years\r\n of age, children are excluded from this study, but will be eligible for future\r\n pediatric trials.\r\n\r\n - ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A).\r\n\r\n - Life expectancy of greater than 3 months in the opinion of the investigator.\r\n\r\n - Patients must have acceptable organ and marrow function as defined below:\r\n\r\n - Leukocytes (WBCs) ≥3,000/uL\r\n\r\n - absolute neutrophil count ≥1,500/uL\r\n\r\n - hemoglobin > 9 g/dl (patients may be transfused to this level)\r\n\r\n - platelets ≥ 100,000/uL\r\n\r\n - total bilirubin < 1.5 x institutional upper limit of normal OR > 1.5 x\r\n institutional upper limit of normal allowed if direct bilirubin is within normal\r\n range.\r\n\r\n - AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal\r\n\r\n - PT/INR and PTT < 1.3 x ULN1\r\n\r\n - Serum creatinine ≤1.5 mg/dL OR creatinine clearance ≥50 mL/min/1.73 m2\r\n\r\n - Potassium >3 and <5.5mmol/L\r\n\r\n - Magnesium >1.2 and <2.5 mg/dL\r\n\r\n - 1Therapeutic levels of anti-coagulation are permitted if clinically indicated, as per\r\n section 3.2.15. Thus PT/INR may be >1.3 if therapeutically anti-coagulated.\r\n\r\n - The effects of INCB039110, dabrafenib, and trametinib on the developing human fetus\r\n are unknown. For this reason, women of child-bearing potential must have a negative\r\n serum pregnancy test within 14 days prior to registration and agree to use effective\r\n contraception (barrier method of birth control, or abstinence; hormonal contraception\r\n is not allowed due to drug-drug interactions which can render hormonal contraceptives\r\n ineffective) from 14 days prior to registration, throughout the treatment period, and\r\n for 4 months after the last dose of study treatment. Should a woman become pregnant or\r\n suspect she is pregnant while she is participating in this study, she should inform\r\n her treating physician immediately.\r\n\r\n - Based on studies in animals, it is also known that dabrafenib may cause damage to the\r\n tissue that makes sperm. This may cause sperm to be abnormal in shape and size and\r\n could lead to infertility, which may be irreversible.\r\n\r\n - Men with a female partner of childbearing potential must have either had a prior\r\n vasectomy or agree to use effective contraception. Additionally, male subjects\r\n (including those who are vasectomized) whose partners are pregnant or might be\r\n pregnant must agree to use condoms for the duration of the study and for 4 months\r\n following completion of therapy.\r\n\r\n - Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n - Able to swallow and retain oral medication, and must not have any clinically\r\n significant gastrointestinal abnormalities that may alter absorption such as\r\n malabsorption syndrome or major resection of the stomach or bowels\r\n\r\n Exclusion Criteria:\r\n\r\n - Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed\r\n toxicity, extensive radiotherapy, immunotherapy, biologic therapy, or vaccine therapy)\r\n within the last 3 weeks prior to Day 1 of Cycle 1. Patients are permitted to be on\r\n dabrafenib and trametinib at start of therapy without wash-out period prior to Day 1\r\n of Cycle 1. Dosing will change to protocol determined dose levels on Day 1 of Cycle 1\r\n\r\n - Patients must not have received prior JAK1 inhibitor therapy.\r\n\r\n - Patients who are receiving any other investigational agents. Patients who have taken\r\n an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is\r\n shorter, prior to registration.\r\n\r\n - Patients with history of RAS mutation-positive tumors are not eligible regardless of\r\n interval from the current study. Prospective RAS testing is not required. However, if\r\n the results of previous RAS testing are known, they must be used in assessing\r\n eligibility.\r\n\r\n - Patients must have no clinical evidence of leptomeningeal or brain metastasis causing\r\n spinal cord compression that are symptomatic, untreated, not stable for ≥ 4 weeks\r\n prior to Day 1 of Cycle 1 (must be documented by imaging), or requiring\r\n corticosteroids to manage metastasis-related symptoms. Subjects who have been off of\r\n corticosteroids for at least 2 weeks prior to Day 1 of Cycle 1 or are on a stable dose\r\n of ≤10 mg per day of a prednisone equivalent for >1 month prior to Day 1 of Cycle 1\r\n can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for >4\r\n weeks prior to Day 1 of Cycle 1.\r\n\r\n - History of known immediate or delayed hypersensitivity reactions attributed to\r\n compounds of similar chemical or biologic composition to INCB039110, dabrafenib, or\r\n trametinib, or excipients or to dimethyl sulfoxide (DMSO).\r\n\r\n - Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n serious infection, symptomatic congestive heart failure, unstable angina pectoris,\r\n cardiac arrhythmia, uncontrolled diabetes, or psychiatric illness/social situations\r\n that would limit compliance with study requirements.\r\n\r\n - Pregnant women are excluded from this study because INCB039110, dabrafenib, and\r\n trametinib may have teratogenic or abortifacient effects. Because there is an unknown\r\n but potential risk for adverse events in nursing infants secondary to treatment of the\r\n mother with the study drugs, breastfeeding should be discontinued prior to the mother\r\n being treated with the study drugs.\r\n\r\n - History of interstitial lung disease or pneumonitis.\r\n\r\n - Patients known to be HIV-positive patients and on combination antiretroviral therapy\r\n are ineligible because of the potential for pharmacokinetic interactions with the\r\n study drugs. In addition, these patients are at increased risk of lethal infections\r\n when treated with marrow-suppressive therapy. Appropriate studies will be undertaken\r\n in patients receiving combination antiretroviral therapy when indicated.\r\n\r\n - History of another malignancy other than the study indication under this trial within\r\n 5 years of study enrollment. Does not apply to subjects who underwent successful\r\n definitive resection of basal or squamous cell carcinoma of the skin, superficial\r\n bladder cancer, in situ cervical cancer, in situ breast cancer, or other in situ\r\n cancers.\r\n\r\n - History or current evidence/risk of retinal vein occlusion (RVO) or retinal pigment\r\n epithelial detachment (RPED):\r\n\r\n - History of RVO or RPED, or predisposing factors to RVO or RPED (e.g.,\r\n uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such\r\n as hypertension, diabetes mellitus, or history of hyperviscosity or\r\n hypercoagulability syndromes).\r\n\r\n - Visible retinal pathology as assessed by ophthalmic exam that is considered a\r\n risk factor for RVO or RPED such as evidence of new optic disc cupping, evidence\r\n of new visual field defects, and intraocular pressure >21 mm Hg.\r\n\r\n - History or evidence of cardiovascular risk including any of the following:\r\n\r\n - A QT interval corrected for heart rate using the Bazett's formula QTcB ≥460 msec\r\n on the pre-study baseline single 12 lead EKG.\r\n\r\n - History or evidence of current clinically significant uncontrolled arrhythmias\r\n (exception: patients with controlled atrial fibrillation for >30 days prior to\r\n registration are eligible).\r\n\r\n - History of acute coronary syndromes (including myocardial infarction and unstable\r\n angina), coronary angioplasty, or stenting within 6 months prior to registration.\r\n\r\n - History or evidence of current ≥ Class II congestive heart failure as defined by\r\n the New York Heart Association (NYHA) functional classification system\r\n\r\n - Treatment-refractory hypertension defined as a blood pressure of systolic >140\r\n mmHg and/or diastolic >90 mmHg which cannot be controlled by anti-hypertensive\r\n therapy. In patients with no history of hypertension and a pre-study baseline\r\n blood pressure of systolic >140 mmHg and/or diastolic >90 mmHg, a second reading\r\n should be taken at least 1 minute later, with the two readings averaged to obtain\r\n a final BP measurement.\r\n\r\n - Abnormal cardiac valve morphology (≥grade 2) documented by echocardiogram\r\n (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be\r\n entered on study). Subjects with moderate valvular thickening should not be\r\n entered on study.\r\n\r\n - Prior placement of an implantable defibrillator\r\n\r\n - History of or identification on screening imaging of intracardiac metastases\r\n\r\n - No known active infection with Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).\r\n Patients with chronic or cleared HBV infection and HCV infection are eligible.\r\n\r\n - For patients requiring anti-coagulation with vitamin K antagonists, therapeutic level\r\n dosing of warfarin can be used with close monitoring of PT/INR by the site. Exposure\r\n may be decreased due to enzyme induction when on treatment, thus warfarin dosing may\r\n need to be adjusted based upon PT/INR. Consequently, when discontinuing dabrafenib,\r\n warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin\r\n dose adjustments must be made as clinically appropriate. If clinically indicated,\r\n prophylactic low dose warfarin may be given to maintain central catheter patency.\r\n\r\n - Current use of a prohibited medication. The following medications or non-drug\r\n therapies are prohibited\r\n\r\n - Other anti-cancer therapy while on study treatment. (note: megestrol [Megace] if\r\n used as an appetite stimulant is allowed).\r\n\r\n - Concurrent treatment with bisphosphonates is permitted; however, treatment must\r\n be initiated prior to the first dose of study therapy. Prophylactic use of\r\n bisphosphonates in patients without bone disease is not permitted, except for the\r\n treatment of osteoporosis.\r\n\r\n - Because the composition, PK, and metabolism of many herbal supplements are\r\n unknown, the concurrent use of all herbal supplements is prohibited during the\r\n study (including, but not limited to, St. John's wort, kava, ephedra [ma huang],\r\n ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng).\r\n\r\n - Patients receiving any medications or substances that are strong inhibitors or\r\n inducers of CYP3A or CYP2C8 are ineligible. Current use of, or intended ongoing\r\n treatment with: herbal remedies (e.g., St. John's wort), or strong inhibitors or\r\n inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1)\r\n should also be excluded\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Trametinib', 'Dabrafenib', 'INCB039110']\n- **Description:** [\"Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth.\", 'Dabrafenib may work by stopping your cancer cells from duplicating.', 'Itacitinib may work by stopping your tumor cells from living and growing.']\n- **Mesh Terms:** ['Trametinib', 'Dabrafenib']\nSMILES: ['CN1C(=O)C(C)=C2N(C(=O)N(C3CC3)C(=O)C2=C1NC1=CC=C(I)C=C1F)C1=CC(NC(C)=O)=CC=C1', 'CC(C)(C)C1=NC(=C(S1)C1=NC(N)=NC=C1)C1=C(F)C(NS(=O)(=O)C2=C(F)C=CC=C2F)=CC=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03762681
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection\n\n**Trial Summary:** \n\n\n This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and\r\n pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and\r\n participants diagnosed with chronic hepatitis B (CHB).\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Hepatitis B Virus Infection\n\n**Condition Keywords:** ['Infections', 'Communicable Diseases', 'Hepatitis A', 'Virus Diseases', 'Hepatitis B', 'Hepatitis B, Chronic', 'Herpesviridae Infections', 'Hepatitis']\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n All Parts\r\n\r\n -Female participants should be of non-childbearing potential and male participants who are\r\n with pregnant partners or partners of childbearing potential must agree to remain abstinent\r\n or use contraceptive measures\r\n\r\n Part 1 (SAD HV only)\r\n\r\n - Healthy, as judged by the Investigator\r\n\r\n - Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on\r\n Day 1, and agrees to remain non-smoker during the study\r\n\r\n Part 2 (CHB only)\r\n\r\n - Positive serum HBsAg status for > 6 months prior to screening\r\n\r\n - Serum HBsAg level ≥ 250 IU/mL at screening\r\n\r\n - On stable entecavir or tenofovir (alone or in combination) treatment and having\r\n received the same drug in the 3 months prior to randomisation\r\n\r\n - HBV DNA below the lower limit of quantification (LLQ) for ≥ 6 months prior to\r\n screening by local testing, and confirmed at screening\r\n\r\n - Screening laboratory values (including hematology, chemistry, urinalysis) within\r\n normal ranges\r\n\r\n - No past or current diagnosis of cirrhosis\r\n\r\n Exclusion Criteria:\r\n\r\n All Parts\r\n\r\n - History or presence of significant cardiovascular, respiratory, hepatic, renal,\r\n gastrointestinal, endocrine, hematological disorders, or diagnosed central or\r\n peripheral neurological disease, capable of altering the absorption, metabolism, or\r\n elimination of drugs, or constituting a risk when taking the study treatment, or of\r\n interfering with the interpretation of the data\r\n\r\n - History of lymphoma, leukemia, or malignancy within the past five years\r\n\r\n - Positive for human immunodeficiency virus (HIV) infection\r\n\r\n - Participant under judicial supervision, guardianship or curatorship\r\n\r\n Part 1 (SAD HV only)\r\n\r\n - Screening ECG showing clinically relevant abnormalities\r\n\r\n - Abnormal blood pressure\r\n\r\n - History or presence of liver disease, or known hepatic or biliary abnormalities\r\n\r\n - Alanine aminotransferase (ALT) ≥1.5 × upper limit of normal (ULN)\r\n\r\n - Any clinically significant out of range findings in other laboratory test results or\r\n any other clinically significant (as judged by the Investigator) abnormalities in the\r\n physical examination at screening and on Day -1\r\n\r\n - Positive for hepatitis B surface antigen (HBsAg), or hepatitis B core total antibody\r\n [anti-HBc]), or hepatitis C virus (HCV) antibody test result\r\n\r\n Part 2 (CHB only)\r\n\r\n - History or presence of bridging fibrosis or cirrhosis or decompensated liver disease\r\n\r\n - History or presence of a medical condition associated with liver disease other than\r\n HBV infection. Other known hepatic or biliary abnormalities\r\n\r\n - History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) ≥13\r\n ng/mL\r\n\r\n - History of having received (in the last six months) or currently receiving any\r\n systemic antineoplastic (including radiation) or immune-modulatory treatment\r\n (including systemic corticosteroids)\r\n\r\n - History of organ transplantation\r\n\r\n - Estimated glomerular filtration rate (eGFR) <70 mL/min/1.73m^2\r\n\r\n - Confirmed QT interval corrected using Fridericia's formula (QTcF) >450 ms\r\n\r\n - Expected to need any other systemic antiviral therapy at any time during participation\r\n in the study\r\n\r\n - Positive hepatitis C antibody test\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['RO7239958', 'Placebo']\n- **Description:** ['Solution for injection, subcutaneous use (SC).', 'Sodium chloride solution for injection, SC']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02914379
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of LY3337641 in Healthy Male Participants\n\n**Trial Summary:** \n\n\n The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how\r\n long it takes the body to get rid of it. In addition, the safety and tolerability of the\r\n study drug will be evaluated.\r\n\r\n Participants will be admitted to a clinical research unit (CRU) the day before dosing.\r\n Participants remain confined to the CRU for at least 7 days. Participants may be discharged\r\n from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days\r\n post-dose (Day 22).\r\n\r\n This study will last approximately 30 days for each participant, not including screening.\r\n Screening is required within 28 days prior to the start of the study.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Overtly healthy males, as determined by medical history and physical examination\r\n\r\n - Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²)\r\n\r\n - Have clinical laboratory test results within normal reference range for the population\r\n or investigative site, or results with acceptable deviations that are judged to be not\r\n clinically significant by the investigator\r\n\r\n - Have venous access sufficient to allow for blood sampling as per the protocol\r\n\r\n - Are able and willing to give signed informed consent\r\n\r\n - Generally have a minimum of 1 bowel movement per day\r\n\r\n Exclusion Criteria:\r\n\r\n - Have participated, within the last 30 days, in a clinical trial involving an\r\n investigational product. If the previous investigational product has a long half-life,\r\n 3 months or 5 half-lives (whichever is longer, if known) should have passed\r\n\r\n - Have a significant history of or current cardiovascular, respiratory, hepatic, renal,\r\n gastrointestinal (GI) (cholecystectomy not acceptable), endocrine, hematological,\r\n dermatologic, or neurological disorders capable of significantly altering the\r\n absorption, metabolism, or elimination of drugs; of constituting a risk when taking\r\n the investigational product; or of interfering with the interpretation of data\r\n\r\n - Regularly use known drugs of abuse and/or show positive findings on urinary drug\r\n screening\r\n\r\n - Have used or intend to use over-the-counter or prescription medication, including\r\n herbal medications, within 14 days prior to dosing\r\n\r\n - Have donated blood of more than 500 milliliter (mL) within the month prior to\r\n screening\r\n\r\n - Have an average weekly alcohol intake that exceeds 21 units per week, and are\r\n unwilling to stop alcohol consumption for 48 hours prior to admission, and while\r\n resident in the clinical research unit (CRU)\r\n\r\n - In the opinion of the investigator or sponsor, are unsuitable for inclusion in the\r\n study\r\n\r\n - Have had exposure to significant diagnostic, therapeutic, or employment related\r\n radiation within 12 months prior to dosing (serial x-ray or computed tomography scans,\r\n barium meal, current employment in a job requiring radiation exposure monitoring)\r\n\r\n - Have participated in a [¹⁴C] study within the last 6 months prior to admission for\r\n this study. The total 12-month exposure from this study and a maximum of one other\r\n previous [¹⁴C]-study within 6 to 12 months of this study must be within the Code of\r\n Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1): less\r\n than 5000 Milli-rem (mrem) /year whole body annual exposure\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** [¹⁴C]-LY3337641\n- **Description:** Administered orally\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02269423
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nVaccine Treatment for Ebola Virus in Healthy Adults (V920-001)\n\n**Trial Summary:** \n\n\n This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire\r\n ebolavirus) also known as V920 and BPSC-1001. The purpose of this study is to test how safe\r\n the vaccine is in humans and how well it makes the human immune system cause an immune- or\r\n defense-response to Ebola virus. This vaccine will be studied at different doses.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Ebola Virus\n\n**Condition Keywords:** Hemorrhagic Fever, Ebola\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 50 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Healthy adult male or non-pregnant, non-lactating female, ages 18 to 50 (inclusive) at\r\n the time of screening\r\n\r\n - Have provided written informed consent before screening\r\n\r\n - Free of clinically significant health problems, as determined by pertinent medical\r\n history and clinical examination prior to entry into the study\r\n\r\n - Available, able, and willing to participate for all study visits and procedures\r\n\r\n - Males and females who are willing to practice abstinence from sexual intercourse, or\r\n willing to use effective methods of contraception, from at least 30 days prior to\r\n vaccination until study end.\r\n\r\n - Be willing to minimize blood and body fluid exposure of others for 7 days after\r\n vaccination\r\n\r\n - Score at least 80% on the Comprehension Assessment test\r\n\r\n Exclusion Criteria:\r\n\r\n - History of prior infection with a filovirus or prior participation in a filovirus\r\n vaccine trial\r\n\r\n - History of prior infection with VSV or receipt of a VSV vectored vaccine\r\n\r\n - Is a healthcare worker who has direct contact with patients\r\n\r\n - Has a house-hold contact (HHC) who is immunodeficient, Human Immunodeficiency Virus\r\n (HIV)-positive, pregnant, has an unstable medical condition, or is under the age of 5\r\n years\r\n\r\n - Is a childcare worker who has direct contact with children 5 years of age or younger\r\n\r\n - Directly prepares food in the food industry\r\n\r\n - History of employment in an industry involved in contact with ruminant animals,\r\n veterinary sciences, or other potential exposure to VSV\r\n\r\n - Planned or frequent contact with animals at-risk of VSV infection (e.g. cattle,\r\n horses, pigs, mules, etc.)\r\n\r\n - History of employment or activity which involves potential contact with filoviruses\r\n\r\n - History of severe local or systemic reactions to any vaccination or a history of\r\n severe allergic reactions\r\n\r\n - Known allergy to the components of the BPSC1001 vaccine product\r\n\r\n - Receipt of investigational product up to 30 days prior to enrollment or ongoing\r\n participation in another clinical trial\r\n\r\n - Receipt of licensed vaccines within 30 days of planned study immunization\r\n\r\n - Ongoing participation in another clinical trial\r\n\r\n - Ability to observe possible local reactions at the eligible injections sites (deltoid\r\n region) is, in the opinion of the investigator, unacceptably obscured due to a\r\n physical condition or permanent body art\r\n\r\n - Acute or chronic, clinically significant psychiatric, hematologic, pulmonary,\r\n cardiovascular, or hepatic or renal functional abnormality as determined by the\r\n investigator based on medical history, physical exam, electrocardiogram, and/or\r\n laboratory screening test. This would include a known hemoglobinopathy or coagulation\r\n abnormality.\r\n\r\n - Any baseline laboratory screening tests which is outside of acceptable range as\r\n defined in the protocol.: alanine aminotransferase, aspartate aminotransferase,\r\n creatinine, hemoglobin, platelet count, total white blood cell count, urine protein,\r\n urine occult blood, urine glucose\r\n\r\n - Any serologic evidence of hepatitis B or C infection\r\n\r\n - Any confirmed or suspected immunosuppressive or immunodeficient condition, including\r\n HIV infection, cytotoxic therapy in the previous 5 years, and/or diabetes\r\n\r\n - Any chronic or active neurologic disorder, including migraines, seizures, and\r\n epilepsy, excluding a single febrile seizure as a child\r\n\r\n - Have an active malignancy or history of metastatic or hematologic malignancy\r\n\r\n - Suspected or known alcohol and/or illicit drug abuse within the past 5 years\r\n\r\n - Moderate or severe illness and/or fever >100.4F within one week prior to vaccination\r\n\r\n - Pregnant or lactating female, or female who intends to become pregnant during the\r\n study period\r\n\r\n - Administration of immunoglobulins and/or any blood products within the 120 days\r\n preceding study entry or planned administration during the study period\r\n\r\n - History of blood donation within 60 days of enrollment or plans to donate within the\r\n study period\r\n\r\n - Administration of chronic (defined as more than 14 days) immunosuppressants or other\r\n immune modifying drugs within 6 months of study entry. (For corticosteroids, this will\r\n mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day, Intranasal and\r\n topical steroids are allowed)\r\n\r\n - Unwilling to allow storage and use of blood for future vaccine research\r\n\r\n - Any other significant finding that in the opinion of the investigator would increase\r\n the risk of the individual having an adverse outcome from participating in this study\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['V920', 'Placebo']\n- **Description:** ['Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.', 'Normal saline placebo.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT01625611
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nKappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors\n\n**Trial Summary:** \n\n\n The primary purpose of the study is to increase our knowledge of receptor function in the\r\n brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has\r\n been approved for the treatment of alcohol dependence. Receptors are special molecules in the\r\n brain to which other molecules (neurotransmitters) attach during the normal every-day\r\n workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence\r\n suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking\r\n behavior. This study will try to determine if naltrexone's ability to attach to these\r\n receptors is related to its effectiveness. We will use PET (positron emission tomography) for\r\n this study. PET is a type of imaging device found in nuclear medicine. It is used for\r\n tracking the presence of injected radioactive materials in the body.\r\n \n\n**Trial Keywords:** ['Alcohol', 'Drinking', 'Drinkers', 'Alcohol Drinking', 'Naltrexone', 'Alcohol Dependence', 'Alcohol Abuse', 'Alcohol-Related Disorders', 'Ethanol', 'Alcoholism']\n\n**Phase:** Phase 1\n\n**Condition:** Alcohol Drinking\n\n**Condition Keywords:** ['Alcohol Drinking', 'Drinking Behavior']\n\n**ICD Code:** [\"['Z58.6']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 21 Years\n- **Maximum Age:** 50 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Ages 21-50\r\n\r\n - Able to read English at 6th grade level or higher and to complete study evaluations\r\n\r\n - Regular alcohol drinker\r\n\r\n Exclusion Criteria:\r\n\r\n - Individuals who are seeking alcohol treatment\r\n\r\n - Medical conditions that would contraindicate the use of study medication\r\n\r\n - Regular use of other substances\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Naltrexone\n- **Description:** Naltrexone 100 mg titrated over one week\n- **Mesh Terms:** Naltrexone\nSMILES: ['[H][C@@]12OC3=C(O)C=CC4=C3[C@@]11CCN(CC3CC3)[C@]([H])(C4)[C@]1(O)CCC2=O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03531762
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEffect of a Proton Pump Inhibitor on the PK of Tepotinib\n\n**Trial Summary:** \n\n\n This study was investigated in healthy participants (i) the effect of omeprazole (proton pump\r\n inhibitor) co-administration on the single dose pharmacokinetics (PK) of tepotinib under fed\r\n conditions, and (ii) the effect of food on the single dose PK of tepotinib after\r\n co-administration of omeprazole and tepotinib. Furthermore, the study assessed the safety and\r\n tolerability of tepotinib alone and upon co-administration of omeprazole.\r\n \n\n**Trial Keywords:** ['Proton Pump Inhibitor', 'Omeprazole', 'Tepotinib', 'Non-small cell lung cancer (NSCLC)', 'Pharmacokinetics']\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Healthy participants of non-child bearing potential\r\n\r\n - Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)\r\n\r\n - Body weight between 50 to 100 kilogram (kg)\r\n\r\n - Other protocol defined inclusion criteria could apply\r\n\r\n Exclusion Criteria:\r\n\r\n - Participation in a clinical study within 60 days prior to first drug administration\r\n\r\n - Whole blood donation or loss of greater than (>) 450 milliliter (mL) within 60 days\r\n prior to first drug administration\r\n\r\n - Any surgical or medical condition, or any other significant disease that could\r\n interfere with the study objectives, conduct, or evaluation\r\n\r\n - Other protocol defined exclusion criteria could apply\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Tepotinib', 'Omeprazole']\n- **Description:** ['Participants received single oral dose of 500 mg Tepotinib in Treatment A, B and C.', 'Participants received omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment B and C.']\n- **Mesh Terms:** ['Tepotinib', 'Omeprazole']\nSMILES: ['CN1CCC(COC2=CN=C(N=C2)C2=CC(CN3N=C(C=CC3=O)C3=CC(=CC=C3)C#N)=CC=C2)CC1', 'COC1=CC2=C(C=C1)N=C(N2)S(=O)CC1=NC=C(C)C(OC)=C1C']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02273388
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nBI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours\n\n**Trial Summary:** \n\n\n The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI\r\n 6727 therapy in terms of drug-related adverse events. Secondary objectives are the collection\r\n of overall safety and antitumour efficacy data and the determination of the pharmacokinetic\r\n profile of BI 6727.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Neoplasms\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion criteria:\r\n\r\n 1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic\r\n solid tumours, who have failed conventional treatment, or for whom no therapy of\r\n proven efficacy exists, or who are not amenable to established forms of treatment\r\n\r\n 2. Age 18 years or older\r\n\r\n 3. Written informed consent consistent with ICH-GCP and local legislation\r\n\r\n 4. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2\r\n\r\n 5. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-,\r\n hormone-, immuno-, or radiotherapies (except alopecia)\r\n\r\n The 18 additional patients recruited at the MTD must also meet the following\r\n criterion:\r\n\r\n 6. Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI)\r\n\r\n Exclusion criteria:\r\n\r\n 1. Serious illness or concomitant non-oncological disease considered by the investigator\r\n to be incompatible with the protocol\r\n\r\n 2. Pregnancy or breastfeeding\r\n\r\n 3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection\r\n\r\n 4. Clinical evidence of active brain or leptomeningeal disease during the past 12 months\r\n\r\n 5. Second malignancy currently requiring active therapy\r\n\r\n 6. Absolute neutrophil count less than 1500 / mm3\r\n\r\n 7. Platelet count less than 100 000 / mm3\r\n\r\n 8. Bilirubin greater than 1.5 mg / dl (> 26 ¿mol / L, SI unit equivalent)\r\n\r\n 9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater\r\n than 2.5 times the upper limit of normal (if related to liver metastases greater than\r\n five times the upper limit of normal)\r\n\r\n 10. Serum creatinine greater than 1.5 mg / dl (> 132 ¿mol / L, SI unit equivalent)\r\n\r\n 11. Known history of relevant QT-prolongation, e.g. long QT-syndrome\r\n\r\n 12. Women and men who are sexually active and unwilling to use a medically acceptable\r\n method of contraception\r\n\r\n 13. Treatment with other investigational drugs or participation in another clinical trial\r\n within the past four weeks before start of therapy or concomitantly with this trial\r\n (except for present trial drug)\r\n\r\n 14. Chemo-, radio or immunotherapy within the past four weeks before start of therapy or\r\n concomitantly with this trial. This restriction does not apply to steroids and\r\n bisphosphonates.\r\n\r\n 15. Patients unable to comply with the protocol\r\n\r\n 16. Active alcohol or drug abuse\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** BI 6727\n- **Description:** BI 6727\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT04274075
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEvaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential\n\n**Trial Summary:** \n\n\n This study will be an open-label, randomized, three-period, six-sequence crossover study of\r\n GDC-9545 administered to healthy females of non-childbearing potential to determine the\r\n relative bioavailability of the Phase 3 capsule formulation to the Phase 1 tablet formulation\r\n in the fasted state and the effect of food on the Phase 3 capsule formulation.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy Volunteers\n\n**Condition Keywords:** None\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Female\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Females of non-childbearing potential including non-pregnant, non-lactating, and\r\n either postmenopausal or surgically sterile for at least 90 days prior to screening,\r\n as defined in the protocol\r\n\r\n - Body mass index (BMI) from 18.5 to 30.0 kilograms per square metre of body surface\r\n area (kg/m^2) at screening\r\n\r\n - In good health, determined by no clinically significant findings from medical history,\r\n 12-lead ECG, or vital signs\r\n\r\n - Clinical laboratory evaluations within the reference range for the test laboratory,\r\n unless deemed not clinically significant by the investigator\r\n\r\n - Negative test for selected drugs of abuse at Screening (does not include alcohol) and\r\n at Check-in (Day -1) for Period 1 (does include alcohol)\r\n\r\n - Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody)\r\n and negative human immunodeficiency virus (HIV) antibody screens\r\n\r\n - Subject must receive an explanation of the mandatory Research Biosample Repository\r\n (RBR) component of the study and be able to comprehend and willing to sign an Informed\r\n Consent Form (ICF)\r\n\r\n Exclusion Criteria:\r\n\r\n - Significant history or clinical manifestation of any metabolic, allergic,\r\n dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,\r\n gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the\r\n investigator)\r\n\r\n - History of significant hypersensitivity, intolerance, or allergy to any drug compound,\r\n food, or other substance, unless approved by the investigator\r\n\r\n - History of allergy to GDC-9545 or any of its excipients\r\n\r\n - History of stomach or intestinal surgery (including cholecystectomy) or resection that\r\n would potentially alter absorption and/or excretion of orally administered drugs\r\n (except that appendectomy and hernia repair will be allowed)\r\n\r\n - History or presence of an abnormal ECG that, in the investigator's opinion, is\r\n clinically significant including complete left bundle branch block; right bundle\r\n branch block; first-, second-, or third-degree heart block; sick sinus syndrome; or\r\n evidence of prior myocardial infarction\r\n\r\n - Having a QTc interval greater than (>)470 milliseconds (msec), PR interval >210 msec,\r\n or QRS complex >120 msec\r\n\r\n - Confirmed (e.g., 2 consecutive measurements) baseline heart rate ≤50 beats per minute\r\n (bpm) prior to enrollment\r\n\r\n - History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1) of\r\n Period 1\r\n\r\n - The use of tobacco- or nicotine-containing products within 6 months prior to Check-in\r\n (Day -1) of Period 1\r\n\r\n - History of active or latent tuberculosis (TB), regardless of treatment history\r\n\r\n - History of previous use of tamoxifen, aromatase inhibitors, or any other endocrine\r\n agent for the treatment of breast cancer\r\n\r\n - The use of hormone replacement therapy or selective ER modulators (SERMs; e.g.,\r\n raloxifene) within 1 year prior to Check-in (Day -1) of Period 1\r\n\r\n - The use of oral antibiotics within 4 weeks or intravenous antibiotics within 8 weeks\r\n prior to Check-in (Day -1) of Period 1\r\n\r\n - The use or intent to use any medications/products known to alter drug absorption,\r\n metabolism, or elimination processes, including St. John's wort, within 30 days prior\r\n to Check-in (Day -1) of Period 1\r\n\r\n - The participation in any other investigational study drug trial in which receipt of an\r\n investigational study drug occurred within 5 half-lives or 30 days, whichever is\r\n longer, prior to Check-in (Day -1) of Period 1\r\n\r\n - The use of drugs of abuse (including opioids) within 4 weeks of Screening\r\n\r\n - The use of any prescription medications/products within 14 days prior to Check-in (Day\r\n -1) of Period 1, unless deemed acceptable by the investigator\r\n\r\n - The use of any over-the-counter, non-prescription preparations (including vitamins;\r\n minerals; and phytotherapeutic-, herbal-, and plant-derived preparations) within 7\r\n days prior to Check-in (Day -1) of Period 1, unless deemed acceptable by the\r\n investigator\r\n\r\n - The use of poppy seed-containing foods or beverages within 7 days prior to Check-in\r\n (Day -1) of Period 1, unless deemed acceptable by the investigator\r\n\r\n - The use of alcohol- or caffeine-containing foods or beverages within 72 hours prior to\r\n Check-in (Day -1) of Period 1, unless deemed acceptable by the investigator\r\n\r\n - Not refraining from strenuous exercise from 7 days prior to Check-in (Day -1) of\r\n Period 1\r\n\r\n - The need to follow a special diet and unable to consume the high-fat meal\r\n\r\n - Poor peripheral venous access\r\n\r\n - History of malignancy, except for appropriately treated carcinoma in situ of the\r\n cervix, non-melanoma skin carcinoma, or Stage I uterine cancer (must be cancer-free\r\n for at least 5 years)\r\n\r\n - Donation of blood from 90 days prior to Screening through Follow-up, inclusive, or of\r\n plasma from 2 weeks prior to Screening\r\n\r\n - Receipt of blood products within 2 months prior to Check-in (Day -1) of Period 1\r\n\r\n - Any acute or chronic condition that, in the opinion of the investigator, would limit\r\n the subject's ability to complete and/or participate in this clinical study\r\n\r\n - In the opinion of the investigator or Sponsor, are unsuitable for inclusion in the\r\n study\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['GDC-9545 Tablet, Fasted: Treatment A', 'GDC-9545 Capsule, Fasted: Treatment B', 'GDC-9545 Capsule, Fed: Treatment C']\n- **Description:** ['One dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.', 'One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.', 'One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water within 30 minutes of eating a high-fat meal.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04177693
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nPharmacokinetics and Hepatic Safety of EGCG\n\n**Trial Summary:** \n\n\n A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without\r\n uterine fibroids.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Uterine Fibroids\n\n**Condition Keywords:** Leiomyoma\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Female\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 40 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Healthy women ≥18 to ≤40 years of age with or without uterine fibroids\r\n\r\n 2. Must use a double-barrier method for contraception\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Subjects using green tea/EGCG within 2 weeks prior to study enrollment\r\n\r\n 2. Known liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5\r\n mg/dL).\r\n\r\n 3. History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks\r\n at one time).\r\n\r\n 4. Subject using hormonal contraceptives\r\n\r\n 5. Subjects who are pregnant or breastfeeding\r\n\r\n 6. Known hypersensitivity to the study drugs\r\n\r\n 7. Any chronic disease\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Epigallocatechin gallate (EGCG)', 'Clomiphene Citrate', 'Letrozole']\n- **Description:** ['800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months', '100 mg for 5 days', '5 mg for 5 days']\n- **Mesh Terms:** ['Letrozole', 'Epigallocatechin gallate', 'Clomiphene', 'Enclomiphene', 'Zuclomiphene']\nSMILES: ['O[C@@H]1CC2=C(O[C@@H]1C1=CC(O)=C(O)C(O)=C1)C=C(O)C=C2O', 'CCN(CC)CCOC1=CC=C(C=C1)C(=C(Cl)C1=CC=CC=C1)C1=CC=CC=C1', 'N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02731469
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nStudy of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers\n\n**Trial Summary:** \n\n\n BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics,\r\n Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy\r\n Volunteers\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Reticulocyte Count\n\n**Condition Keywords:** None\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 45 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Signing of the Informed Consent Form;\r\n\r\n 2. Male sex;\r\n\r\n 3. Age of 18 to 45 years, inclusive;\r\n\r\n 4. BMI within normal limits (18.5-24.9 kg/m2);\r\n\r\n 5. Healthy patients, which is proved by their medical history, physical examination and\r\n laboratory findings:\r\n\r\n - No clinically significant abnormalities of circulatory, respiratory, nervous,\r\n hematopoietic, endocrine and digestive systems, liver and kidneys in the past\r\n medical history and at screening;\r\n\r\n - No history of cardiovascular disorders or thyroid disorders;\r\n\r\n - No history of hematologic disorders, including but not limited to any type of\r\n anemia, myelodysplastic syndrome, blood cancers, hemolytic syndrome,\r\n hemoglobinopathies, coagulopathies;\r\n\r\n - CBC results within normal limits, including:\r\n\r\n - Hemoglobin within 132-173 g/L;\r\n\r\n - Hematocrit (based on CBC results) within 39-49%;\r\n\r\n - Platelet count within 150-400*109/L;\r\n\r\n - Absolute reticulocyte count within 30.4-93.5 * 109/L;\r\n\r\n - Blood biochemistry and urinalysis results within normal limits;\r\n\r\n - Serum ferritin within 20-250 µg/L;\r\n\r\n - Serum endogenous erythropoietin within 4.3-29.0 MIU/mL;\r\n\r\n - Hemodynamic parameters within normal limits: systolic blood pressure within\r\n 100-139 mmHg; diastolic blood pressure within 60-90 mmHg; heart rate within 50-90\r\n bpm;\r\n\r\n - No history of chronic infections (tuberculosis) or chronic inflammation;\r\n\r\n - No hepatitis B or C, HIV, or syphilis;\r\n\r\n - No acute infections within 4 weeks prior to inclusion in the study;\r\n\r\n - No psychiatric disorders and other conditions (including depression) that can\r\n interfere with the volunteer's ability to follow the study protocol;\r\n\r\n - Well-being (in the volunteer's opinion) within 30 days prior to inclusion in the\r\n study;\r\n\r\n 6. No history of or current (at baseline) alcohol or drug abuse;\r\n\r\n 7. Ability of the volunteer, in the investigator's opinion, to follow the study protocol\r\n procedures;\r\n\r\n 8. Willingness of volunteers and their sexual partners with preserved reproductive\r\n potential to use reliable contraception within 2 weeks before inclusion in the study\r\n and up to 7 weeks after the injection of the test product. This criterion is not\r\n applicable to subjects who underwent surgical sterilization. Reliable methods of\r\n contraception include one barrier method in combination with one of the following\r\n methods: spermicides, intrauterine device/oral contraceptives (for sexual partners).\r\n\r\n 9. Willingness of volunteers to avoid alcohol intake within 24 hours before and 8 days\r\n after each injection of the test drug;\r\n\r\n Exclusion Criteria:\r\n\r\n 1. History of treatment with erythropoietins or any other ESAs;\r\n\r\n 2. Acute bleeding, blood/plasma donation or blood transfusion within 2 months before\r\n inclusion in the study;\r\n\r\n 3. History of chronic bleeding;\r\n\r\n 4. Standard laboratory and instrumental findings outside normal limits at screening;\r\n\r\n 5. History of allergies (anaphylactic shock or multiple drug allergy syndrome);\r\n\r\n 6. Known allergy or intolerance to any components of the investigational product;\r\n\r\n 7. Major surgery within 30 days prior to screening, or surgery being scheduled for any\r\n time during the study;\r\n\r\n 8. Impossibility to install a venous catheter for blood sampling (e.g. because of skin\r\n disorders at the sites of venipuncture);\r\n\r\n 9. Diseases or other conditions that can interfere with the pharmacokinetics of the\r\n investigational drug (e.g. chronic liver, kidney, blood, circulatory system, lung or\r\n neuroendocrine diseases, including diabetes mellitus and others);\r\n\r\n 10. History of fever of 40 °C or more;\r\n\r\n 11. History of elevated hepatic transaminases (above 2.5xULN);\r\n\r\n 12. Episodes of thrombosis and/or thromboembolia in past medical history (myocardial\r\n infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary\r\n embolism within 6 months prior to inclusion in the study) as well as an increased risk\r\n of deep vein thrombosis;\r\n\r\n 13. History of epileptic attacks or seizures;\r\n\r\n 14. History or current (at screening) depression, suicidal thoughts/ attempts;\r\n\r\n 15. Regular oral or parenteral use of any medications including over-the-counter drugs,\r\n vitamins and nutritional additives within 2 weeks before a scheduled injection of the\r\n test drug;\r\n\r\n 16. Use of drugs, including OTC products, that significantly affect the hemodynamics,\r\n hepatic function, etc. (barbiturates, omeprazole, cimetidine, etc.) within 30 days\r\n before a scheduled injection of the test drug;\r\n\r\n 17. Vaccination within 4 weeks before a scheduled injection of the test drug;\r\n\r\n 18. Smoking more than 10 cigarettes per day;\r\n\r\n 19. Consumption of more than 10 portions of alcohol per week (one portion equals to 0.5 L\r\n of beer, 200 mL of wine or 50 mL of ethanol) or a history of alcohol, drug or\r\n medication abuse;\r\n\r\n 20. Participation in other clinical studies within 1 month before screening or\r\n simultaneous participation in another clinical study;\r\n\r\n 21. Previous participation in this study.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['BCD-131', 'Mircera®', 'Aranesp®']\n- **Description:** None\n- **Mesh Terms:** Darbepoetin alfa\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT00121719
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nAn Open Label Dose Escalation Study Of E7080\n\n**Trial Summary:** \n\n\n The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in\r\n patients with solid tumors or lymphomas.\r\n \n\n**Trial Keywords:** ['Resistant and refractory solid tumors', 'lymphomas', 'hodgkins disease', 'non-hodgkins lymphoma', 'neoplasms']\n\n**Phase:** Phase 1\n\n**Condition:** Solid Tumor or Lymphoma\n\n**Condition Keywords:** Lymphoma\n\n**ICD Code:** [\"['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n INCLUSION CRITERIA:\r\n\r\n Patients must meet all of the inclusion criteria outlined below in order to be eligible to\r\n participate in the study:\r\n\r\n 1. Patients with histologically and/or cytologically confirmed solid tumor or lymphoma\r\n who are resistant/refractory to approved therapies or for whom no appropriate\r\n therapies are available.\r\n\r\n 2. All previous treatment (including surgery and radiotherapy) must have been completed\r\n at least four weeks prior to study entry and any acute toxicities must have resolved.\r\n\r\n 3. Aged greater than or equal to 18 years.\r\n\r\n 4. Karnofsky performance status greater than or equal 70%.\r\n\r\n 5. Written informed consent to participate in the study.\r\n\r\n EXCLUSION CRITERIA:\r\n\r\n Patients with the following characteristics will not be eligible for the study:\r\n\r\n 1. Brain tumors or brain or leptomeningeal metastases.\r\n\r\n 2. Any of the following laboratory parameters:\r\n\r\n 1. hemoglobin less than 9 g/dl (5.6 mmol/L)\r\n\r\n 2. neutrophils less than 1.5 x 10^9/L\r\n\r\n 3. platelets less than 100 x 10^9/L\r\n\r\n 4. serum bilirubin greater than 25 micro-mol/l (1.5 mg/dl)\r\n\r\n 5. other liver parameters greater than 3 x the upper limit of normal (ULN)\r\n\r\n 6. serum creatinine greater than 1.5 x ULN or creatinine clearance less than 60\r\n ml/minute\r\n\r\n 3. Uncontrolled infections.\r\n\r\n 4. Clinically significant cardiac impairment or unstable ischemic heart disease including\r\n a myocardial infarction within six months of study start.\r\n\r\n 5. Any treatment with investigational drugs within 30 days before the start of the study.\r\n\r\n 6. Pregnancy or lactation (all women of childbearing potential must have a negative\r\n pregnancy test before inclusion in the study; post-menopausal women must be\r\n amenorrheic for at least 12 months). Female patients of childbearing potential must\r\n use adequate contraceptive protection, defined as two forms of contraception, one of\r\n which must be a barrier method.\r\n\r\n 7. Fertile males not willing to use contraception or whose female partners are not using\r\n adequate contraceptive protection.\r\n\r\n 8. History of alcoholism, drug addiction, or any psychiatric or psychological condition\r\n which, in the opinion of the investigator, would impair study compliance.\r\n\r\n 9. Legal incapacity.\r\n\r\n 10. Centrally located or squamous cell carcinoma of the lung.\r\n\r\n 11. Proteinuria greater than 1+ on bedside testing.\r\n\r\n 12. History of gastrointestinal malabsorption.\r\n\r\n 13. Surgery involving gastro- and/or intestinal anastomosis within four weeks of study\r\n start.\r\n\r\n 14. Patients with bleeding or thrombotic disorders.\r\n\r\n 15. Patients using therapeutic dosages of anticoagulants.\r\n\r\n 16. Poorly controlled hypertension (defined as a change in hypertensive therapy within\r\n three months of study start) or patients diagnosed with hypertension (defined as a\r\n repeat blood pressure measurement of 160/90 mmHg or higher) at screening.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Lenvatinib\n- **Description:** Lenvatinib tablets taken orally, once daily.\n- **Mesh Terms:** Lenvatinib\nSMILES: ['COC1=C(C=C2C(OC3=CC=C(NC(=O)NC4CC4)C(Cl)=C3)=CC=NC2=C1)C(N)=O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03571204
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nCombination Therapy With 3BNC117 and 10-1074 in HIV-Infected Individuals\n\n**Trial Summary:** \n\n\n Background:\r\n\r\n Human immunodeficiency virus (HIV) affects the immune system. The main function of the immune\r\n system is protect you from infections and other diseases such as cancer. HIV attacks and\r\n cripples the immune system making people more susceptible to a variety of infections and\r\n cancers. Currently, the standard treatment for HIV infection is a daily administration of\r\n anti-HIV drugs. These drugs are called combination antiretroviral therapy (ART). ART is very\r\n effective at suppressing HIV, but does not cure HIV infection. ART must be taken continuously\r\n for life to be effective. ART can stop being effective if not taken correctly and can cause\r\n permanent side effects. Researchers want to see if two new products can control HIV infection\r\n without the use of ART. The products are the antibodies 3BNC117 and 10-1074.\r\n\r\n Objective:\r\n\r\n To see if 3BNC117 and 10-1074 are safe and can control HIV levels in the blood of people who\r\n are not taking ART or people who stop taking their ART during the study. .\r\n\r\n Eligibility:\r\n\r\n Adults ages 18-65 with HIV who are:\r\n\r\n - on ART and willing to stop treatment for at least 28 weeks\r\n\r\n - OR not taking ART with low levels of HIV in the blood\r\n\r\n Design:\r\n\r\n Participants will be screened with a physical exam, medical history, and blood, heart, and\r\n urine tests.\r\n\r\n Participants will get the 2 study products or salt water (placebo). A thin tube will be\r\n placed in an arm vein. Each product will be given directly into the vein for about 1 hour.\r\n\r\n To help collect blood cells to study in the laboratory, participants may have a procedure\r\n known as leukapheresis in which blood will be removed through a needle in the arm. Some of\r\n the white blood cells will be separated from the blood and used for research studies to see\r\n how 3BNC117 and 10-1074 effects HIV and the immune system. The rest of the blood will be\r\n returned to the person through another needle in the arm.\r\n\r\n Participants will have 18 study visits over 28 weeks. They will repeat some screening tests.\r\n They may have leukapheresis again.\r\n\r\n At 8 study visits, participants will get the study products or placebo.\r\n\r\n All participants will be followed for at least 24 weeks after their last dose of the study\r\n infusions. Participants who are in the Group that stops ART will be monitored closely to make\r\n sure the levels of virus in their blood do not go to high. If at any time during this the\r\n study a person develops HIV-related symptoms, or if the viral levels go up to high levels for\r\n more than 4 weeks, ART will be restarted and no further infusions of 3BNC117 and 10-1074 will\r\n be given.\r\n\r\n ...\r\n \n\n**Trial Keywords:** ['Treatment Interruption', 'Neutralizing Monoclonal Antibody']\n\n**Phase:** Phase 1\n\n**Condition:** HIV\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['B20', 'Z71.7', 'Z29.81', 'O98.72', 'Z21', 'O98.73', 'R75']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n - INCLUSION CRITERIA:\r\n\r\n General Inclusion Criteria for both Groups:\r\n\r\n 1. Age 18-65 years old.\r\n\r\n 2. HIV-1 infection and clinically stable.\r\n\r\n 3. General good health and has an identified primary health care provider for medical\r\n management of HIV infection and is willing to maintain a relationship with a primary\r\n health care provider for medical management of HIV infection while participating in\r\n the study.\r\n\r\n 4. Cluster of differentiation 4 (CD4)+ T cell count >450 cells/mm(3) at screening.\r\n\r\n 5. Laboratory values within pre-defined limits at screening:\r\n\r\n 1. Absolute neutrophil count >1,000/mm(3).\r\n\r\n 2. Hemoglobin levels >10.0 g/dL for men and >9.0 g/dL for women.\r\n\r\n 3. Platelet count >100,000/mm(3).\r\n\r\n 4. Estimated or a measured glomerular filtration rate >60 mL/min/1.73m(2) as\r\n determined by the National Institutes of Health (NIH) Clinical Center laboratory.\r\n\r\n 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels of\r\n <2.5 times upper limit of normal (ULN), direct bilirubin within the normal range\r\n for the NIH Clinical Center laboratory.\r\n\r\n 6. Willingness to have samples stored for future research.\r\n\r\n Inclusion criteria specific for Group 1:\r\n\r\n 7. Institution of ART within 12 weeks of being diagnosed with primary HIV-1 infection\r\n\r\n 8. Primary HIV-1 infection is defined as meeting at least one of the following criteria:\r\n\r\n 1. Detectable plasma HIV-1 RNA levels of >2000 copies/mL with a negative result from\r\n an HIV-1 enzyme immunoassays (EIA), or\r\n\r\n 2. Positive result from an HIV-1 EIA with a negative or indeterminate result from an\r\n HIV-1 western blot or another confirmatory antibody test that subsequently\r\n evolves to a confirmed positive result, or\r\n\r\n 3. Negative result from an HIV-1 EIA within the past 4 months and HIV-1 RNA levels\r\n of >400,000 copies/mL, in the setting of a potential exposure to HIV-1.\r\n\r\n 4. Negative result from an HIV-1 EIA within 6 months prior to a positive result from\r\n an HIV-1 EIA and an HIV-1 western blot or another confirmatory antibody test.\r\n\r\n 5. Presence of low level of HIV antibodies as determined by having a positive EIA or\r\n a positive Western blot with a non-reactive detuned EIA according to a serologic\r\n testing algorithm for recent infection.\r\n\r\n 9. Documentation of continuous ART treatment with suppression of plasma viral level below\r\n the limit of detection for greater than or equal to 1 years. Individuals with blips\r\n (i.e., detectable viral levels on ART) prior to screening may be included provided\r\n they satisfy the following criteria:\r\n\r\n 1. The blips are <400 copies/mL, and\r\n\r\n 2. Succeeding viral levels return to levels below the limit of detection on\r\n subsequent testing.\r\n\r\n 10. Willingness to undergo ATI\r\n\r\n 11. Willingness for both male and female subjects to agree to use barrier protection\r\n methods or abstinence during the ATI phase of the study to decrease the risk of HIV\r\n transmission.\r\n\r\n Inclusion criteria specific for Group 2:\r\n\r\n 12. No ART within 24 months of screening.\r\n\r\n 13. HIV plasma viremia between 200 and 5,000 copies/mL at screening AND at least two\r\n documented viral level greater than or equal to 200 copies/mL in the 12 months prior\r\n to screening.\r\n\r\n At the screening visit, subjects considering enrollment in Group 2 will be advised that\r\n current guidelines recommend treatment of all individuals with HIV infection regardless of\r\n viral levels and CD4 counts.\r\n\r\n Reproductive Risks\r\n\r\n Contraception: The effects of 3BNC117 and 10-1074 on the developing human fetus are\r\n unknown. For this reason, men and women of childbearing potential must agree to use\r\n adequate pregnancy prevention. This includes the use an effective method of contraception\r\n (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting intrauterine\r\n device (IUD), hormone-based contraceptive with condom) for the study duration. Subjects\r\n should also agree to use a male or female condom while off ART. Pregnancy prevention must\r\n be practiced continuously for the duration of study participation. Females of\r\n childbearing-age must have a negative pregnancy test result prior to receiving each\r\n infusion of 3BNC117/10-1074. During the course of the study, if a female subject, or the\r\n partner of a male subject suspects or in fact becomes pregnant, the effected subject should\r\n inform the study staff immediately, as well as the woman s primary care physician.\r\n\r\n EXCLUSION CRITERIA:\r\n\r\n 1. Chronic hepatitis B, as evidenced by a positive test for hepatitis B surface antigen\r\n\r\n (HBsAg), or chronic hepatitis C virus (HCV) infection, as evidenced by a positive test\r\n for HCV RNA. Subjects with a positive test for HCV antibody and a negative test for\r\n HCV RNA are eligible.\r\n\r\n 2. HIV immunotherapy or vaccine(s) received within 1 year prior to screening.\r\n\r\n 3. Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza,\r\n pneumococcal polysaccharide) received within 2 weeks prior to study enrollment.\r\n\r\n 4. Receipt of other investigational study agent within 28 days of enrollment.\r\n\r\n 5. Any active malignancy that may require systemic chemotherapy or radiation therapy.\r\n\r\n 6. Systemic immunosuppressive medications received within 3 months prior to enrollment\r\n (Not excluded: [1] corticosteroid nasal spray or inhaler; [2] topical corticosteroids\r\n for mild, uncomplicated dermatitis; or [3] oral/parenteral corticosteroids\r\n administered for non-chronic conditions not expected to recur [length of therapy less\r\n than or equal to10 days, with completion in greater than or equal to 30 days prior to\r\n enrollment]).\r\n\r\n 7. History or other clinical evidence of:\r\n\r\n 1. Significant or unstable cardiac or cerebrovascular disease (e.g., angina,\r\n congestive heart failure, recent stroke or myocardial infarction).\r\n\r\n 2. Severe illness, malignancy, immunodeficiency other than HIV, or any other\r\n condition that, in the opinion of the investigator, would make the subject\r\n unsuitable for the study.\r\n\r\n 8. Active drug or alcohol use or any other pattern of behavior that, in the opinion of\r\n the investigator, would interfere with adherence to study requirements.\r\n\r\n 9. Pregnancy or breast-feeding at time of screening.\r\n\r\n 10. Documented multiclass antiretroviral drug resistance that, in the judgment of the\r\n investigator, would pose a risk of virologic failure should additional mutations\r\n develop during the study (Group 1 only).\r\n\r\n Co-enrollment Guidelines: Co-enrollment in other trials is restricted to observational\r\n studies or those evaluating the use of a licensed medication and is subject to approval of\r\n the principal investigator (PI).\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['3BNC117 and 10-1074', 'Placebo']\n- **Description:** ['Both 3BNC117 and 10-1074 administered intravenously at 30 mg/kg dose level in 250 ml normal saline for 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The two antibodies will be mixed in separate bags of saline for sequential administration.', 'Placebo is two separate bags of 250 ml normal saline administered intravenously for 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The two separate bags of placebo are administered sequentially.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03902574
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nBioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg\n\n**Trial Summary:** \n\n\n To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional\r\n tablet 2 mg\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy Adult Male\n\n**Condition Keywords:** None\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 20 Years\n- **Maximum Age:** 39 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Healthy Japanese males\r\n\r\n - BMI ［body weight in kg /(height in m)2］ of at least 18.5 kg/m2 and less than 25.0\r\n kg/m2 (as a result of at the screening examination)\r\n\r\n - Capable of providing written informed consent prior to initiation of any trial-related\r\n procedures, and able, in the opinion of the investigator, to comply with all\r\n requirements of the trial\r\n\r\n Exclusion Criteria:\r\n\r\n - Clinically significant abnormality at the time of screening (eg, significant deviation\r\n from reference ranges) or in medical history that, in the opinion of investigator,\r\n subinvestigator, or sponsor may place the subject at risk or interfere with outcome\r\n variables such as drug absorption, distribution, metabolism, and excretion\r\n\r\n - History of serious mental disorder\r\n\r\n - History of drug or alcohol abuse within 2 years prior to screening\r\n\r\n - History of any significant drug allergy\r\n\r\n - Use of another investigational drug within 120 days prior to the first administration\r\n of IMP\r\n\r\n - Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange\r\n products, Star fruit, or Star fruit products within 72 hours prior to the first\r\n administration of IMP or consumption of alcohol within 72 hours prior to\r\n administration of IMP\r\n\r\n - Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin\r\n supplements, or consumption of food or beverages containing St. John's Wort within 14\r\n days prior to the first administration of IMP, or use of antibiotics within 30 days\r\n prior to the first administration of IMP\r\n\r\n - History of major surgery of the digestive tract (excluding appendectomy)\r\n\r\n - Any subject who, in the judgement of the investigator or subinvestigator, should not\r\n participate in the trial\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Brexpiprazole ODT 2mg with water', 'Brexpiprazole ODT 2mg without water', 'Brexpiprazole conventional tablet 2mg']\n- **Description:** ['Brexpiprazole ODT 2mg is administered with water.', 'Brexpiprazole ODT 2mg is administered without water.', 'Brexpiprazole conventional tablet 2mg is administered with water.']\n- **Mesh Terms:** Brexpiprazole\nSMILES: ['O=C1NC2=CC(OCCCCN3CCN(CC3)C3=C4C=CSC4=CC=C3)=CC=C2C=C1', 'O=C1NC2=CC(OCCCCN3CCN(CC3)C3=C4C=CSC4=CC=C3)=CC=C2C=C1', 'O=C1NC2=CC(OCCCCN3CCN(CC3)C3=C4C=CSC4=CC=C3)=CC=C2C=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03158272
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread\n\n**Trial Summary:** \n\n\n The purpose of this study is to determine whether an investigational immuno-therapy,\r\n cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of\r\n advanced malignancies.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Advanced Malignancies\n\n**Condition Keywords:** Neoplasms\n\n**ICD Code:** [\"['K74.02', 'G47.22', 'H35.3133', 'H35.3134', 'H35.3113', 'H35.3114', 'H35.3123']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 20 Years\n- **Maximum Age:** None\n- **Criteria:** \n For more information regarding Bristol-Myers Squibb Clinical Trial participation, please\r\n visit www.BMSStudyConnect.com\r\n\r\n Inclusion Criteria:\r\n\r\n - Performance status 0-1\r\n\r\n - Adequate organ function\r\n\r\n - Cohort M1, 2 and C1: Measurable disease\r\n\r\n - Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an\r\n advanced (metastatic and/or unresectable) malignant solid tumor\r\n\r\n - Cohort C2: Documented refractory or relapsed multiple myeloma\r\n\r\n - Subjects must be refractory to or have relapsed after standard therapies, or have no\r\n known effective treatment\r\n\r\n Exclusion Criteria:\r\n\r\n - Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or\r\n leptomeningeal metastases\r\n\r\n - Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC)\r\n\r\n - Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only\r\n evidence of plasma cell dyscrasia\r\n\r\n Other protocol defined inclusion/exclusion criteria could apply\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Cabiralizumab', 'Nivolumab']\n- **Description:** ['Specified dose on specified days', 'Specified dose on specified days']\n- **Mesh Terms:** Nivolumab\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT01999335
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma\n\n**Trial Summary:** \n\n\n The purpose of the Phase 1 part of the study is to determine the maximum tolerated dose and\r\n assess the safety, tolerability and activity of oprozomib in combination with pomalidomide\r\n and dexamethasone in adults with primary refractory or relapsed and refractory multiple\r\n myeloma.\r\n\r\n The purpose of the Phase 3 part of the study is to compare the efficacy for adults with\r\n primary refractory or relapsed and refractory multiple myeloma who are randomized to either\r\n oprozomib or placebo in combination with pomalidomide and dexamethasone.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Multiple Myeloma\n\n**Condition Keywords:** ['Multiple Myeloma', 'Neoplasms, Plasma Cell']\n\n**ICD Code:** [\"['C90.01', 'C90.02', 'C90.00']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Key Inclusion Criteria:\r\n\r\n 1. Multiple myeloma that is primary refractory or relapsed and refractory after at least\r\n 2 lines of standard for multiple myeloma including:\r\n\r\n 1. ≥ 2 consecutive cycles of both bortezomib and lenalidomide or thalidomide (alone\r\n or in combination)\r\n\r\n 2. In the dose-expansion and Phase 3 portions of the study only: In addition to the\r\n above, treatment with adequate alkylator therapy, defined as:\r\n\r\n i. High-dose melphalan or other alkylating agent as conditioning for autologous or\r\n allogeneic stem cell transplant (SCT), or ii. ≥ 6 cycles of induction therapy, or iii.\r\n Progressive disease after ≥ 2 cycles\r\n\r\n 2. Disease progression on or within 60 days of completion of the last therapy\r\n\r\n 3. Measurable disease as indicated by 1 or more of the following:\r\n\r\n 1. Serum M-protein ≥ 500 mg/dL\r\n\r\n 2. Urine M-protein ≥ 200 mg/24 h\r\n\r\n 3. For patients without measurable serum or urine M protein, serum free light chain\r\n (SFLC): Involved free light chain (FLC) concentration ≥ 10 mg/dL provided SFLC\r\n ratio is abnormal\r\n\r\n 4. Males and females ≥ 18 years old\r\n\r\n 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\r\n\r\n Key Exclusion Criteria:\r\n\r\n 1. Systemic chemotherapy with approved or investigational anticancer therapeutics,\r\n intended to treat underlying malignancy, within 3 weeks before the first dose or 6\r\n weeks for antibody therapy\r\n\r\n 2. Dexamethasone at cumulative doses greater than 160 mg or equivalent within 21 days\r\n prior to the first dose of study treatment is not allowed. Use of topical or inhaled\r\n steroids is acceptable.\r\n\r\n 3. Radiation therapy within 3 weeks before first dose. Radioimmunotherapy within 8 weeks\r\n before first dose.\r\n\r\n 4. Plasmapheresis is not permitted at any time during the Screening period or while the\r\n subject is receiving study treatment. If a subject has started Screening procedures\r\n requiring plasmapheresis, or is anticipated to require plasmapheresis during or after\r\n the Screen\r\n\r\n 5. Autologous SCT within 8 weeks or allogeneic SCT within 16 weeks prior to initiation of\r\n study treatment. Patients with prior allogeneic SCT should not have evidence of\r\n moderate-to-severe graft-versus-host disease (as defined in Filipovich 2005).\r\n\r\n 6. Known hypersensitivity to any immunomodulatory drugs (IMiDs), including Grade 4 rash\r\n\r\n 7. Prior treatment of any duration with pomalidomide\r\n\r\n 8. Known hypersensitivity or intolerance to dexamethasone\r\n\r\n 9. Prior exposure to oprozomib\r\n\r\n 10. Congestive heart failure (New York Heart Association Class III to IV), symptomatic\r\n ischemia, conduction abnormalities uncontrolled by conventional intervention, or\r\n myocardial infarction within 6 months before first dose.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Oprozomib', 'Pomalidomide', 'Dexamethasone']\n- **Description:** ['Extended release (ER) tablets administered orally', 'Capsules for oral administration', 'Tablets for oral administration']\n- **Mesh Terms:** ['Dexamethasone', 'Pomalidomide']\nSMILES: ['COC[C@H](NC(=O)[C@H](COC)NC(=O)C1=CN=C(C)S1)C(=O)N[C@@H](CC1=CC=CC=C1)C(=O)[C@@]1(C)CO1', 'NC1=CC=CC2=C1C(=O)N(C1CCC(=O)NC1=O)C2=O', '[H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03657264
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nCardiac Safety Evaluation of P03277\n\n**Trial Summary:** \n\n\n The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled\r\n and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.\r\n\r\n The primary objective is to assess the cardiac safety after administration of P03277 to 48\r\n healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg\r\n (supra-clinical dose) by evaluating the QT and QTc intervals.\r\n \n\n**Trial Keywords:** ['Gadolinium-based contrast agent', 'Cardiac safety', 'ECG', 'Gadopiclenol']\n\n**Phase:** Phase 1\n\n**Condition:** Healthy Volunteers\n\n**Condition Keywords:** None\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 59 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Subject assessed as healthy by a comprehensive clinical assessment (detailed medical\r\n history and complete physical examination)\r\n\r\n - Subject with a Body Mass Index (BMI) > 19 kg/m² and < 28 kg/m² and a weight at least\r\n of 40 kg for female and 50 kg for male and at maximum of 100 kg\r\n\r\n Exclusion Criteria:\r\n\r\n -\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['P03277 0.1 mmol/kg', 'Moxifloxacin 400mg', 'NaCl 0.9%', 'P03277 0.3 mmol/kg']\n- **Description:** ['Single intravenous bolus injection at 2 mL/sec', 'One tablet per os', 'Single intravenous bolus injection at 2 mL/sec', 'Single intravenous bolus injection at 2 mL/sec']\n- **Mesh Terms:** Moxifloxacin\nSMILES: ['[H][C@]12CN(C[C@@]1([H])NCCC2)C1=C(F)C=C2C(=O)C(=CN(C3CC3)C2=C1OC)C(O)=O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02438423
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nInactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle\n\n**Trial Summary:** \n\n\n Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of\r\n Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.\r\n\r\n This is a single center, partially blinded, randomized phase I study in which healthy adult\r\n subjects (ages 18-49) will receive either inactivated influenza vaccine (IIV) (either by\r\n microneedle patch or hypodermic needle) or placebo (by microneedle patch). This study is\r\n designed to investigate the safety, reactogenicity, acceptability and immunogenicity of an\r\n inactivated influenza vaccine delivered by microneedle patch.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Influenza\n\n**Condition Keywords:** Influenza, Human\n\n**ICD Code:** [\"['J11.81', 'J11.82', 'J10.01', 'J10.81', 'J10.82', 'J11.08', 'J11.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 49 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Subject provides written informed consent prior to any study procedures being\r\n performed.\r\n\r\n 2. Subject is male or non-pregnant female between the ages of 18 and 49, inclusive, on\r\n the day of signing informed consent.\r\n\r\n 3. Subject is in good health as determined by vital signs, medical history and targeted\r\n physical examination\r\n\r\n 4. Women of childbearing potential must agree to practice abstinence from sexual\r\n intercourse with men or use acceptable contraception, initiated at least 30 days prior\r\n to the study vaccination throughout D180 in order to avoid pregnancy.\r\n\r\n 5. Women of childbearing potential must have a negative urine pregnancy test prior to\r\n administration of the study product.\r\n\r\n 6. Subject is able to understand and comply with required study procedures.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Subject has received a 2014-2015 seasonal influenza vaccine.\r\n\r\n 2. Subject with documented influenza infection during the 2014-2015 influenza season.\r\n\r\n 3. Subject has touched or handled a microneedle patch prior to study enrollment\r\n (excluding dermaroller-like devices).\r\n\r\n 4. Subject has a known allergy to eggs, egg or chicken protein or other components of the\r\n study product\r\n\r\n 5. Subject has a history of severe reactions following previous immunization with\r\n licensed influenza virus vaccines.\r\n\r\n 6. Subject has an acute illness with fever (temperature >100.4 °F) within 72 hours prior\r\n to vaccination.\r\n\r\n 7. Subject has a known chronic medical problem\r\n\r\n 8. Subject has known immunosuppression due to underlying illness or treatment\r\n\r\n 9. Subject has a scar, tattoo, rash or other dermatologic condition in the area of the\r\n vaccination site which will interfere with the assessment of injection site\r\n reactogenicity.\r\n\r\n 10. Subject has a history of keloid formation.\r\n\r\n 11. Subject has used long-term* high-dose** oral or parenteral glucocorticoids, or\r\n high-dose inhaled steroids***.\r\n\r\n - Long term is defined as taken for 2 weeks or more in total at any time during the\r\n past 2 months.\r\n\r\n - High dose defined as prednisone ≥ 20 mg total daily dose, or equivalent dose of\r\n other glucocorticoids.\r\n\r\n - High dose defined as > 800 mcg/day of beclomethasone dipropionate or equivalent.\r\n\r\n If short term corticosteroids are given, then the subject should not receive study\r\n vaccination or have blood collected for immunogenicity studies within 1 week of\r\n steroid administration\r\n\r\n 12. Subject has a history of Guillain-Barre Syndrome.\r\n\r\n 13. Subject is pregnant, post-partum (<12 months after delivery), or breast feeding or\r\n plans to breastfeed during the study.\r\n\r\n 14. Alcohol or drug abuse and psychiatric conditions that, in the opinion of the\r\n investigator, would preclude compliance with the trial or interpretation of safety or\r\n endpoint data.\r\n\r\n 15. Subject has any condition that, in the opinion of the investigator, may put the\r\n subject at increased risk of harm, may cause the subject to be unable to meet the\r\n requirements or might otherwise interfere with evaluations required by the study.\r\n\r\n 16. Subject has received any experimental products within 30 days before study entry or\r\n plan to receive experimental products at any time during the study.\r\n\r\n 17. Subject has received a live vaccine within 28 days prior to study entry or plans to\r\n receive a live vaccine prior to Day 28 of the study.\r\n\r\n 18. Subject has received an inactivated vaccine within 14 days prior to study entry or\r\n plans to receive an inactivated vaccine prior to Day 28 of the study.\r\n\r\n 19. Subject has received immunoglobulin or blood products in the past 90 days or planned\r\n receipt at any time during the study.\r\n\r\n 20. Subject BMI >35 kg/m2.\r\n\r\n 21. Subject has a systolic blood pressure >160 or < 80 mmHg or diastolic blood pressure\r\n >100 or < 60 mmHg.\r\n\r\n 22. Subject has a resting pulse rate < 50 bpm or >100 bpm.\r\n\r\n 23. Subject donated blood 56 days before screening OR will donate blood on or before day\r\n 28 of the study.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Inactivated influenza vaccine', 'Placebo']\n- **Description:** Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03473197
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA 6-Week Study to Evaluate the Photoallergic Potential of Diacerein 1% Ointment in Healthy Volunteers\n\n**Trial Summary:** \n\n\n A study in healthy male and female adult volunteers to determine the potential of diacerein\r\n 1% ointment to induce a photoallergic skin reaction using a controlled photopatch testing\r\n procedure.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Key Inclusion Criteria:\r\n\r\n - Is a healthy male or female (to be confirmed by medical history);\r\n\r\n - Is 18 years of age or older;\r\n\r\n - In the case of a female of childbearing potential, is using an acceptable form of\r\n birth control;\r\n\r\n - In the case of a female of childbearing potential, has a negative urine pregnancy test\r\n (UPT) at Day 1 and are willing to submit to a UPT at the end of study (EOS);\r\n\r\n - Is free of any systemic or dermatological disorder, which, in the opinion of the\r\n Investigator, will interfere with the study results or increase the risk of AEs;\r\n\r\n - Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow\r\n discernment of erythema\r\n\r\n Key Exclusion Criteria:\r\n\r\n - Has a history of photosensitivity or photoallergy;\r\n\r\n - Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the\r\n study, or systemic/topical antihistamines 72 hours prior to and during the study;\r\n\r\n - Is not willing to refrain from using systemic/topical anti-inflammatory analgesics\r\n such as aspirin, (occasional use of acetaminophen will be permitted);\r\n\r\n - Are taking medication known to cause phototoxic reactions (eg, tetracyclines,\r\n thiazides, nonsteroidal anti-inflammatory drugs [NSAIDS]);\r\n\r\n - Is using medication which, in the opinion of the Investigator, will interfere with the\r\n study results;\r\n\r\n - Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams,\r\n ointments, lotions or similar products on the back during the study;\r\n\r\n - Has psoriasis and/or active atopic dermatitis/eczema;\r\n\r\n - Had a known sensitivity or allergy to constituents of the materials being evaluated\r\n including diacerein, mineral oil, petrolatum, cetyl alcohol, D&C Yellow #10 and/or\r\n ethyl paraben;\r\n\r\n - Has damaged skin in or around the test sites, including sunburn, excessively deep\r\n tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other\r\n disfigurations of the test site;\r\n\r\n - Has received treatment for any type of internal cancer within 5 years prior to study\r\n entry;\r\n\r\n - Has any known sensitivity to adhesives; and/or\r\n\r\n - Has received any investigational drugs(s) with 4 weeks prior to study entry\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Diacerein 1% ointment\n- **Description:** During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.\n- **Mesh Terms:** Diacerein\nSMILES: ['CC(=O)OC1=CC=CC2=C1C(=O)C1=C(OC(C)=O)C=C(C=C1C2=O)C(O)=O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03984812
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEvaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study\n\n**Trial Summary:** \n\n\n This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled,\r\n FTIH study, that includes both single-ascending and multiple-ascending dose phase to assess\r\n the safety, tolerability, and pharmacokinetic (PK)/pharmacodynamic (PD) attributes of\r\n GSK3732394 in healthy subjects. The data gathered in this study will further enable clinical\r\n development of GSK3732394 in HIV-infected subjects. Approximately 72 healthy subjects will be\r\n randomized in the FTIH study. Part 1 will be the single ascending dose (SAD) phase and Part 2\r\n will be the multiple ascending dose (MAD) phase. Each subject in the SAD cohort will receive\r\n a single dose of blinded GSK3732394 or blinded placebo (PBO) in 6:2 ratio. Part 1 will\r\n consist of five ascending single-dose cohorts with an additional expansion cohort included as\r\n needed. Part 2 will consist of up to three ascending repeat-dose cohorts (MAD Cohorts 1, 2,\r\n and 3), randomized to four weekly doses of blinded GSK3732394 or blinded PBO in 6:2 ratio to\r\n be administered on Days 1, 8, 15, and 22.\r\n \n\n**Trial Keywords:** DAIDS, FTIH, HIV-1, MAD, SAD\n\n**Phase:** Phase 1\n\n**Condition:** HIV Infections\n\n**Condition Keywords:** HIV Infections\n\n**ICD Code:** [\"['Z21']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 50 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Subjects must be 18 to 50 years of age inclusive, at the time of signing the informed\r\n consent.\r\n\r\n - Subjects who are overtly healthy as determined by medical evaluation including medical\r\n history, physical examination, laboratory tests, and cardiac monitoring.\r\n\r\n - Subjects who are able to understand and comply with protocol requirements and\r\n timetables, instructions, and protocol-stated restrictions\r\n\r\n - Body mass index within the range 19 to 30 kilogram per meter square (kg/m2) inclusive,\r\n in addition to a weight range of 50kg to 100kg.\r\n\r\n - Male and female healthy volunteers.\r\n\r\n - All male subjects must agree to use contraception during the treatment period and for\r\n at least 100 days after the last dose of study treatment and refrain from donating\r\n sperm during this period.\r\n\r\n - A female subject is eligible to participate if she is not pregnant, not breastfeeding,\r\n and at least one of the following conditions applies; Not a woman of childbearing\r\n potential (WOCBP), A WOCBP who agrees to follow the contraceptive guidance during the\r\n treatment period and for at least 28 days prior to first dose, and 40 days after, the\r\n last dose of study treatment.\r\n\r\n - Capable of giving signed informed consent.\r\n\r\n - A signed and dated written informed consent must be completed prior to the subject's\r\n entry into the study.\r\n\r\n Exclusion Criteria:\r\n\r\n - Subject has a history or presence of cardiovascular, dermatological, respiratory,\r\n hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders\r\n capable of significantly altering the absorption, metabolism, or elimination of drugs;\r\n constituting a risk when taking the study intervention; or interfering with the\r\n interpretation of data.\r\n\r\n - Subject has abnormal blood pressure (as determined by the investigator).\r\n\r\n - Subject had symptomatic herpes zoster within 3 months prior to screening.\r\n\r\n - Evidence of active or latent tuberculosis (TB) as documented by medical history and\r\n examination, TB testing that includes a positive tuberculin skin test [TST]; defined\r\n as a skin induration greater than 5 millimeter [mm] at 48 to 72 hours,and regardless\r\n of Bacillus Calmette-Guerin [BCG] or other vaccination history) or a positive (not\r\n indeterminate) QuantiFERON-TB Gold test.\r\n\r\n - Subjects with lymphoma, leukemia, or any malignancy within the past 5 years except for\r\n basal cell or squamous epithelial carcinomas of the skin that have been resected with\r\n no evidence of metastatic disease for 3 years.\r\n\r\n - Subjects who had breast cancer within the past 10 years.\r\n\r\n - Subjects who had history of severe injection site reaction (i.e., required emergency\r\n care or hospitalization) following any prior injection, including reaction to\r\n vaccines.\r\n\r\n - Subjects with history of clinically significant allergy or prior hypersensitivity\r\n including those with a documented yeast allergy.\r\n\r\n - Subjects with history of, or current concern for, a chronic immune deficiency disorder\r\n including, but not limited to: diabetes, sickle cell anemia, and malnutrition.\r\n\r\n - Subjects having alanine transaminase (ALT) greater than 1.1 x upper limit of normal\r\n (ULN).\r\n\r\n - Subjects with Hemoglobin levels below the normal range.\r\n\r\n - Subjects with Platelet count <130,000 per cubic millimeters.\r\n\r\n - Subjects with Creatinine clearance (CrCL) <90 milliliters per minute.\r\n\r\n - Subjects with bilirubin greater than 1.1xULN (isolated bilirubin greater than 1.1xULN\r\n is acceptable if bilirubin is fractionated and direct bilirubin greater than 35%).\r\n\r\n - Subjects who has current or chronic history of liver disease, or known hepatic or\r\n biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic\r\n gallstones).\r\n\r\n - Subjects having Fridericia QT correction formula (QTcF) greater than 450 milliseconds\r\n (msec).\r\n\r\n - Subjects who had intended use of over-the-counter or prescription medication within 7\r\n days prior to dosing.\r\n\r\n - Subjects who had live vaccine(s) within 1 month prior to screening, or plans to\r\n receive such vaccines during the study.\r\n\r\n - Subjects who had treatment with biologic agents (such as monoclonal antibodies\r\n including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior\r\n to dosing.\r\n\r\n - Subjects who had exposure to immune-modulating medications (including corticosteroids)\r\n within 30-days of Screening.\r\n\r\n - Subjects whose participation in the study would result in loss of blood or blood\r\n products in excess of 500 (milliliter) mL within 56 days.\r\n\r\n - Subjects who had Exposure to more than four new chemical entities within 12 months\r\n prior to the first dosing day.\r\n\r\n - Subjects with current enrollment or past participation within the last 30 days before\r\n signing of consent in this or any other clinical study involving an investigational\r\n study intervention or any other type of medical research.\r\n\r\n - Absolute CD4+ T-cell count and CD4 percent (CD4%) outside of the normal range for the\r\n reference laboratory (to be confirmed at baseline, e.g., Day -1).\r\n\r\n - Subjects who had presence of Hepatitis B surface antigen (HBsAg) at screening.\r\n\r\n - Subjects with positive Hepatitis C antibody test result at screening.\r\n\r\n - Subjects with positive Hepatitis C RNA test result at screening or within 3 months\r\n prior to first dose of study intervention.\r\n\r\n - Subjects with positive pre-study drug/alcohol screen.\r\n\r\n - Subjects with positive human immunodeficiency virus (HIV) antibody test.\r\n\r\n - Subjects with history of regular alcohol consumption within 6 months of the study\r\n defined as: an average weekly intake of greater than 14 units. One unit is equivalent\r\n to 8 grams (g) of alcohol: a half pint (~240 mL) of beer, 1 glass (125 mL) of wine or\r\n 1 (25 mL) measure of spirits.\r\n\r\n - Subjects with urinary cotinine levels indicative of smoking or history or regular use\r\n of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing\r\n devices) within 6 months prior to screening.\r\n\r\n - Subjects who has sensitivity to any of the study interventions, or components thereof,\r\n or drug or other allergy that, in the opinion of the investigator or medical monitor,\r\n contraindicates participation in the study.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['GSK3732394', 'Placebo']\n- **Description:** ['It is composed of an anti-CD4 adnectin, an anti-N17 adnectin, and a peptide inhibitor. This will be provided as a solution for injection in 1 (milliliter) mL glass vials with the unit dose strength of 100 mg/mL', 'Placebo will comprise of 0.9% weight per volume (w/v) sodium chloride.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02916745
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nFeasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer\n\n**Trial Summary:** \n\n\n This research study is being conducted to assess the safety and feasibility of using a new\r\n developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects\r\n with solid tumor in peripheral lung, who are inoperable or refused surgery. It will involve\r\n 10 sites in USA and Canada. Participation will last 6 months.\r\n \n\n**Trial Keywords:** ['Non-small cell lung cancer', 'NSCLC', 'lung cancer', 'lung carcinoma', 'lung metastasis']\n\n**Phase:** Phase 1\n\n**Condition:** ['Non-small Cell Lung Cancer (NSCLC)', 'Lung Metastasis']\n\n**Condition Keywords:** ['Lung Neoplasms', 'Carcinoma, Non-Small-Cell Lung', 'Neoplasm Metastasis']\n\n**ICD Code:** [\"['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Male or female aged 18 or older\r\n\r\n - Diagnosed with histologically confirmed solid tumor located in the peripheral lung\r\n\r\n - Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo\r\n curative surgery\r\n\r\n - May be candidate for, have failed, or does not wish to undergo radiation therapy\r\n\r\n - The tumor is ≤ 3 cm in size and clearly observable in computerized tomography (CT\r\n scan)\r\n\r\n - Able to sign an informed consent\r\n\r\n Exclusion Criteria:\r\n\r\n - Diagnostic of small cell lung cancer\r\n\r\n - Solid tumor located in central lung\r\n\r\n - Presence of concurrent non-solid malignancy\r\n\r\n - Abnormal blood results\r\n\r\n - Received chemotherapy/immunotherapy in the last 4 weeks\r\n\r\n - Tumor invades a major blood vessel\r\n\r\n - Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to\r\n any of its excipients\r\n\r\n - Planned surgical procedure within the next 90 days\r\n\r\n - Coexisting ophthalmic disease likely to require slit-lamp examination within the next\r\n 90 days\r\n\r\n - Acute or chronic medical or psychological illnesses that prevent endoscopy procedures\r\n\r\n - Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during\r\n the study\r\n\r\n - Received PDT during the past 3 months\r\n\r\n - Severe impairment of your kidney or liver function\r\n\r\n - Participates or intends to participate in another drug study (other than observational\r\n studies) during the study\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Porfimer sodium', 'Fiber optic']\n- **Description:** ['After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.', 'A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.']\n- **Mesh Terms:** ['Dihematoporphyrin Ether', 'Trioxsalen']\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03276728
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nStudy to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients\n\n**Trial Summary:** \n\n\n To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple\r\n (Part B) doses of AMG 986 in healthy adults and of ascending multiple oral doses of AMG 986\r\n in heart failure patients (Part C).\r\n \n\n**Trial Keywords:** ['Heart Failure', 'Cardiovascular Diseases', 'Heart Diseases', 'Ejection fraction', 'Heart Failure with reduced ejection fraction', 'Heart Failure with preserved ejection fraction']\n\n**Phase:** Phase 1\n\n**Condition:** ['Heart Failure', 'Healthy Volunteer']\n\n**Condition Keywords:** Heart Failure\n\n**ICD Code:** [\"['I50.814', 'I09.81', 'I50.82', 'I50.89', 'I50.9', 'T86.22', 'I11.0']\", \"['Y99.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 85 Years\n- **Criteria:** \n Inclusion Criteria\r\n\r\n - Subject has provided informed consent prior to initiation of any study-specific\r\n activities/procedures.\r\n\r\n - Male and female subjects ≥ 18 to ≤ 55 years old with no history or evidence of\r\n clinically relevant medical disorders as determined by the investigator and the Amgen\r\n physician (Parts A and B only)\r\n\r\n - Body mass index (BMI) between 18 and 35 kg/m^2, inclusive, at screening.\r\n\r\n - Physical examination including vital signs, clinical laboratory values, and\r\n electrocardiograms (ECGs) are clinically acceptable to the investigator. Abnormal\r\n findings for healthy volunteers and unexpected findings for heart failure patient\r\n subjects will be discussed with Amgen prior to study enrollment.\r\n\r\n - Women must be of non-reproductive potential (ie, postmenopausal)\r\n\r\n - Men must agree to practice an acceptable method of effective birth control while on\r\n study through 11 weeks after receiving the last dose of investigational product (AMG\r\n 986 or placebo). Acceptable methods of effective birth control include sexual\r\n abstinence; vasectomy and testing that shows there are no sperm in the semen; or a\r\n condom with spermicide (men) in combination with barrier methods (diaphragm, cervical\r\n cap or cervical sponge), hormonal birth control or IUS (women).\r\n\r\n - Men must be willing to abstain from sperm donation while on study through 11 weeks\r\n after receiving the last dose of investigational product (AMG 986 or placebo).\r\n\r\n - This inclusion criterion only applies to Parts B and C cohorts. Before inclusion in\r\n the study, subjects will undergo a screening echocardiogram to ensure that the\r\n following parameters can be accurately measured: left ventricular end-systolic and\r\n end-diastolic volumes, left atrial end-systolic and end-diastolic volumes, ejection\r\n fraction, fraction shortening, and end-systolic septal and posterior wall thickness.\r\n\r\n For Part C\r\n\r\n Additional Inclusion Criteria for HFrEF Patients:\r\n\r\n - Subject must be of age 18 to 85 years, have a diagnosis of HF confirmed by medical\r\n records for ≥ 3 months, and be in stable condition for at least 4 weeks.\r\n\r\n - Left ventricular ejection fraction (LVEF) ≤ 40% confirmed by echocardiogram,\r\n radionuclide ventriculography, cardiac magnetic resonance imaging, or contrast\r\n ventriculography within 12 months prior to randomization.\r\n\r\n - New York Heart Association (NYHA) class II or III at screening\r\n\r\n - Sinus rhythm\r\n\r\n - N-terminal pro b-type natriuretic peptide (NT-proBNP) level ≥ 250 pg/ml\r\n\r\n - Patients will be treated with stable, optimal pharmacological therapy for a minimum of\r\n 4 weeks prior to randomization. Treatment of HFrEF includes at least beta-blockers\r\n (carvedilol, metoprolol succinate or bisoprolol) and a RAAS inhibitor (ACEi, ARB or\r\n sacubitril/valsartan).\r\n\r\n Additional Inclusion Criteria for HFpEF patients:\r\n\r\n - Subject must be of age of 18 to 85 years, have a diagnosis of HF confirmed by medical\r\n records for ≥ 3 months, and be in stable condition for at least 4 weeks.\r\n\r\n - LVEF ≥ 50% confirmed by echocardiogram, radionuclide ventriculography, cardiac\r\n magnetic resonance imaging, or contrast ventriculography within 12 months prior to\r\n randomization.\r\n\r\n - LVEF never ≤ 40% in the past\r\n\r\n - NYHA class II or III at screening\r\n\r\n - Sinus rhythm\r\n\r\n - NT-proBNP level ≥ 250 pg/ml\r\n\r\n - Patients will be treated with stable, optimal pharmacological therapy for a minimum of\r\n 4 weeks prior to randomization. Treatment of HFpEF includes at least a daily dose of\r\n diuretics equivalent to furosemide 40 mg.\r\n\r\n - For subjects in Parts A, B and C: Women must have negative results for both the\r\n screening (serum) and day -1 (serum or urine) pregnancy tests\r\n\r\n Exclusion Criteria\r\n\r\n - Currently receiving treatment in another investigational device or drug study, or less\r\n than 30 days or 5 half-lives (whichever is longer), since ending treatment on another\r\n investigational device or drug study(s) prior to receiving the first dose of\r\n investigational product (AMG 986 or placebo).\r\n\r\n - Female subjects who are lactating/breastfeeding or who plan to breastfeed while on\r\n study through 11 weeks after receiving the last dose of investigational product (AMG\r\n 986 or placebo).\r\n\r\n - Male subjects with partners who are pregnant or planning to become pregnant while the\r\n subject is on study through 11 weeks after receiving the last dose of investigational\r\n product (AMG 986 or placebo).\r\n\r\n - Female subjects of reproductive potential.\r\n\r\n - Subjects in Parts A and B of the study: estimated glomerular filtration rate (eGFR)\r\n within the screening period of less than 60 mL/min/1.73m^2 as calculated using the\r\n estimated Modification of Diet in Renal Disease (MDRD) formula.\r\n\r\n - Current or prior malignancy within 5 years of randomization, with the exception of\r\n non-melanoma skin cancers, cervical or breast ductal carcinoma in situ, and\r\n adenocarcinoma of the prostate Stage I or IIa (defined as T1, T2a or T2b, N0, M0 with\r\n documented serum prostate-specific antigen (PSA) < 20 ng/mL and Gleason score ≤ 7) per\r\n the American Joint Committee on Cancer (AJCC) primary tumor, regional lymph nodes, and\r\n distant metastasis system.\r\n\r\n - Positive results for human immunodeficiency virus (HIV), antibodies, hepatitis B\r\n surface antigen (HBsAg), or hepatitis C antibodies (HepCAb).\r\n\r\n - Subject has known sensitivity to any of the products or components to be administered\r\n during dosing.\r\n\r\n - Subject likely to not be available to complete all protocol required study visits or\r\n procedures, and/or to comply with all required study procedures to the best of the\r\n subject and investigator's knowledge.\r\n\r\n - History or evidence of any other clinically significant disorder, condition or disease\r\n with the exception of those outlined above that, in the opinion of the investigator or\r\n Amgen physician, if consulted, would pose a risk to subject safety or interfere with\r\n the study evaluation, procedures or completion.\r\n\r\n - Subject previously has entered this study or has been previously exposed to AMG 986.\r\n\r\n - Concurrent or prior use of strong CYP3A4 inhibitors within 14 days of study Day 1,\r\n including (not limited to): macrolide antibiotics (eg, clarithromycin, telithromycin),\r\n antifungals (eg, itraconazole, voriconazole), antivirals (eg, ritonavir, saquinavir,\r\n indinavir, nelfinavir), nefazodone.\r\n\r\n - Concurrent or prior ingestion of grapefruit or grapefruit products and other foods\r\n that are known to inhibit CYP3A4 within 7 days of study Day 1.\r\n\r\n - Concurrent or prior use of strong CYP3A4 inducers within 28 days of study Day 1,\r\n Including (not limited to): phenytoin, carbamazepine, rifampin, rifabutin, rifapentin,\r\n phenobarbital. Subjects should also not take St John's Wort.\r\n\r\n - Concurrent or prior use of strong P-glycoprotein inhibitors within 28 days of study\r\n Day 1, including (not limited to): elacridar and valspodar.\r\n\r\n - All herbal supplements, vitamins, and nutritional supplements taken within the last 30\r\n days prior to dosing on Day 1 (and continued use, if appropriate), must be reviewed\r\n and approved by the PI and Amgen Medical Monitor.\r\n\r\n - For subjects enrolled under Amendments 1-6, inclusive: QTc > 450 msec or\r\n history/evidence of long QT syndrome.\r\n\r\n - Planned elective surgery within 30 days of study completion or before return of red\r\n blood cell parameters to normal values.\r\n\r\n - Blood donation ≥ 500 mL within 60 days of Day 1.\r\n\r\n - Systolic blood pressure > 150 mmHg or < 90 mmHg, or diastolic blood pressure > 95 mmHg\r\n or < 60 mmHg, assessed on 2 separate occasions prior to enrollment (Parts A and B\r\n only).\r\n\r\n - Heart rate ≥ 100 beats per minute after 5 minutes of rest or an untreated symptomatic\r\n bradyarrhythmia within 1 month prior to enrollment.\r\n\r\n - For Parts A and B: Troponin I at screening > upper limit of normal (ULN).\r\n\r\n - In the opinion of the Investigator, a condition that compromises the ability of the\r\n subject to give written informed consent or to comply with study procedures.\r\n\r\n - Unwilling or unable to abstain from nicotine or tobacco containing products (including\r\n but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine\r\n patches) throughout the screening period and for the duration of the study.\r\n\r\n - Subjects who are unwilling or unable to limit alcohol consumption to 1 units/day (1\r\n unit = 1 drink and 1 drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces\r\n of malt liquor, 5 ounces of wine or 1.5 ounces of 80 proof distilled spirits).\r\n\r\n - Subjects with a positive urine drug screen or alcohol breath test.\r\n\r\n - Known history of drug or alcohol abuse.\r\n\r\n - Concurrent use of phosphodiesterase 5 (PDE5) inhibitors including (not limited to)\r\n avanafil, sildenafil, tadalafil, vardenafil.\r\n\r\n - Concurrent use of vasodilators by healthy subjects in Parts A and B that could in the\r\n opinion of the investigator potentially lead to a drop in blood pressure in\r\n combination with investigational product.\r\n\r\n - Severe uncorrected valvular heart disease, or hypertrophic obstructive cardiomyopathy,\r\n active myocarditis, constrictive pericarditis, or clinically significant congenital\r\n heart disease.\r\n\r\n - For subjects in Part C of the study: eGFR within the screening period of less than 30\r\n mL/min/1.732m^2 as calculated using the MDRD formula.\r\n\r\n - For subjects in Part C of the study: Systolic blood pressure > 160 mmHg or < 100 mmHg,\r\n or diastolic blood pressure > 110 mmHg or < 60 mmHg, assessed on 2 separate occasions\r\n prior to enrollment.\r\n\r\n - For subjects in Part C of the study: troponin I > ULN if there is also evidence of an\r\n acute cardiovascular event.\r\n\r\n - For subjects enrolled in Part C under Amendment 7: QTc > 500 msec or history/evidence\r\n of long QT syndrome.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['AMG 986 IV', 'AMG 986 PO', 'Placebo PO', 'Placebo IV']\n- **Description:** ['AMG 986 solution for infusion', 'AMG 986 tablets for oral (PO) administration', 'Matching placebo tablets for oral administration', 'Matching placebo solution for infusion']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03055000
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety and Immunogenicity of a First-in-Human Mosquito Saliva Peptide Vaccine\n\n**Trial Summary:** \n\n\n Background:\r\n\r\n Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v\r\n vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne\r\n diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person.\r\n\r\n Objective:\r\n\r\n To see if the AGS-v vaccine is safe in humans and how it affects the immune system.\r\n\r\n Eligibility:\r\n\r\n Healthy adults ages 18-50\r\n\r\n Design:\r\n\r\n Participants will be screened another study.\r\n\r\n Participants will be randomly assigned to get either the vaccine with a booster vaccine, the\r\n vaccine without the booster, or a placebo. These are given through a needle in the upper arm.\r\n\r\n Participants will have visits that include medical history, physical exam, and blood and\r\n urine tests:\r\n\r\n Baseline: They will get the vaccine and be monitored for 2 hours.\r\n\r\n Follow-up visits 1 and 2 weeks after baseline.\r\n\r\n Visit 3 weeks after baseline: They will get the booster and be monitored for 2 hours.\r\n\r\n Follow-up visits 1 and 2 weeks after booster visit.\r\n\r\n Visit 3-5 weeks after booster visit: This includes mosquito feeding. Mosquitos grown in the\r\n lab will be allowed to bite the arm. Blood will be drawn 4 times in the 3 hours after the\r\n feeding.\r\n\r\n Phone follow-up a few days after the mosquito feeding.\r\n\r\n After the feeding visit, 5 follow-up visits about every 2 months\r\n\r\n Participants will keep a symptom diary for 7 days after each vaccine. They will record their\r\n temperature. They will measure any redness around the injection site. They will document and\r\n if possible photograph any mosquito bites they get.\r\n \n\n**Trial Keywords:** ['Mosquito-Borne Diseases', 'Universal Mosquito Vaccine', 'Mosquito Transmission', 'Vector Borne Viruses', 'Vaccine']\n\n**Phase:** Phase 1\n\n**Condition:** Mosquito-Borne Disease\n\n**Condition Keywords:** Vector Borne Diseases\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 50 Years\n- **Criteria:** \n -INCLUSION CRITERIA:\r\n\r\n 1. Healthy women and men who are greater than or equal to 18 and less than or equal to 50\r\n years of age.\r\n\r\n 2. Willingness to complete all study visits and comply with all study requirements.\r\n\r\n 3. A male subject is eligible for the study if he agrees to practicing abstinence or\r\n using a condom with spermicide plus an acceptable form of contraception (see inclusion\r\n criteria 4) being used by any female partner from 4 weeks before study start to 12\r\n weeks after the second vaccine administration.\r\n\r\n 4. A female participant is eligible for this study if she is not pregnant or breast\r\n feeding and 1 of the following:\r\n\r\n - Of non-child bearing potential (i.e., women who have had a hysterectomy or tubal\r\n ligation or are postmenopausal, as defined by no menses in greater than or equal\r\n to 1 year).\r\n\r\n - Of childbearing potential but agrees to practice effective contraception or\r\n abstinence for 4 weeks prior to study initiation through 12 weeks after the\r\n second vaccine administration. Acceptable methods of contraception include a male\r\n partner who is sterile and is the sole sexual partner of the female participant\r\n or a male partner who uses a condom with spermicide plus 1 or more of the\r\n following: 1) implants of levonorgestrel; 2) injectable progestogen; 3) an\r\n intrauterine device with a documented failure rate of <1%; 4) oral\r\n contraceptives; and 5) double barrier method including diaphragm.\r\n\r\n 5. Willing to have samples stored for future research (including genetic research).\r\n\r\n 6. Agrees to abstain from alcohol intake for 24 hours prior to each study visit.\r\n\r\n 7. Agrees to not donate blood or blood products throughout the study.\r\n\r\n EXCLUSION CRITERIA:\r\n\r\n 1. Participant has any underlying or current medical condition, which, in the opinion of\r\n the Investigator, would interfere with the participation in the study.\r\n\r\n 2. Individual with body mass index (BMI) less than or equal to 18 and greater than or\r\n equal to 40.\r\n\r\n 3. Participants who have a clinically significant (as determined by the PI) baseline\r\n Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of\r\n clinical significance) by the toxicity table.\r\n\r\n 4. Receipt of blood or blood products (including immunoglobulins) within 3 months prior\r\n to enrollment.\r\n\r\n 5. Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is\r\n greater) prior to enrollment.\r\n\r\n 6. Receipt of any unlicensed vaccine within 6 months prior to enrollment.\r\n\r\n 7. Self-reported or known history of alcoholism or drug abuse within 6 months prior to\r\n enrollment, or positive urine/serum test for drugs of abuse at screening\r\n\r\n 8. Self-reported or known history of psychiatric or psychological issues that require\r\n treatment and are deemed by the PI to be a contraindication to protocol participation.\r\n\r\n 9. History of a previous severe allergic reaction with generalized urticaria, angioedema,\r\n anaphylaxis or anaphylactoid reaction.\r\n\r\n 10. Any condition or event that, in the judgment of the PI, is a contraindication to\r\n protocol participation or impairs the volunteer's ability to give informed consent.\r\n\r\n 11. Has a known allergy to any of the components of the vaccine.\r\n\r\n 12. Has a history of severe immunization reaction.\r\n\r\n 13. Has a severe allergic reaction to mosquito bites\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['AGS-v', 'AGS-v + adjuvant', 'Placebo']\n- **Description:** ['AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21', 'ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL) on Day 0 and on Day 21', 'WFI (0.5mL) on Day 0 and Day 21']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02898207
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nOlaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer\n\n**Trial Summary:** \n\n\n This phase I trial studies the side effects and best dose of olaparib and onalespib when\r\n given together in treating patients with solid tumors that have spread to other places in the\r\n body (metastatic) or cannot be removed by surgery (unresectable) or ovarian, fallopian tube,\r\n primary peritoneal, or triple-negative breast cancer that has come back (recurrent). Olaparib\r\n and onalespib may stop the growth of tumor cells by blocking some of the enzymes needed for\r\n cell growth.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Metastatic High Grade Fallopian Tube Serous Adenocarcinoma', 'Metastatic Malignant Solid Neoplasm', 'Metastatic Primary Peritoneal Serous Adenocarcinoma', 'Metastatic Triple-Negative Breast Carcinoma', 'Platinum-Resistant Fallopian Tube Carcinoma', 'Platinum-Resistant Ovarian Carcinoma', 'Platinum-Resistant Primary Peritoneal Carcinoma', 'Recurrent Breast Carcinoma', 'Recurrent High Grade Fallopian Tube Serous Adenocarcinoma', 'Recurrent High Grade Ovarian Serous Adenocarcinoma', 'Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma', 'Recurrent Triple-Negative Breast Carcinoma', 'Refractory Fallopian Tube Serous Adenocarcinoma', 'Refractory Ovarian Serous Adenocarcinoma', 'Refractory Primary Peritoneal Serous Adenocarcinoma', 'Refractory Triple-Negative Breast Carcinoma', 'Unresectable High Grade Fallopian Tube Serous Adenocarcinoma', 'Unresectable Malignant Solid Neoplasm', 'Unresectable Primary Peritoneal Serous Adenocarcinoma']\n\n**Condition Keywords:** ['Carcinoma', 'Neoplasms', 'Adenocarcinoma', 'Triple Negative Breast Neoplasms', 'Breast Neoplasms', 'Cystadenocarcinoma, Serous', 'Recurrence']\n\n**ICD Code:** [\"['R18.0', 'C17.3', 'G21.0', 'J91.0', 'C05.2', 'C10.0', 'C16.0']\", \"['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']\", \"['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - For the dose escalation cohort, patients must have histologically or cytologically\r\n confirmed malignancy that is metastatic or unresectable and for which standard\r\n curative or palliative measures do not exist or are no longer effective\r\n\r\n - For the dose escalation cohort, patients may have received any number of prior\r\n therapies\r\n\r\n - For the dose expansion cohort, participants must have histologically or cytologically\r\n confirmed diagnosis of either:\r\n\r\n - Ovarian, fallopian tube, or primary peritoneal cancer of high grade serous\r\n histology which has recurred despite standard therapy; up to 3 prior lines in the\r\n platinum resistant setting (i.e. up to 3 lines after patients have become\r\n platinum resistant); patients may have received unlimited lines while platinum\r\n sensitive\r\n\r\n - Triple-negative breast cancer (TNBC) which has recurred despite standard therapy;\r\n recurrent TNBC needs to have metastatic disease and patients with an in breast\r\n recurrence are not eligible; up to 4 prior lines in the recurrent setting for\r\n patients with triple-negative breast cancer are allowed\r\n\r\n - For the dose expansion cohort, patients with ovarian, fallopian tube or primary\r\n peritoneal cancer must have platinum resistant disease defined as progression within 6\r\n months after last platinum regimen; platinum refractory disease is allowed\r\n\r\n - For the dose expansion cohort, patients with triple-negative breast cancer may not be\r\n BRCA1/2 germline mutation carriers\r\n\r\n - Because no dosing or adverse event data are currently available on the use of olaparib\r\n in combination with AT13387 in patients < 18 years of age, children are excluded from\r\n this study, but will be eligible for future pediatric trials.\r\n\r\n - There must be availability of a formalin-fixed, paraffin-embedded tumor specimen\r\n\r\n - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky > 60%)\r\n\r\n - Life expectancy of greater than 12 weeks\r\n\r\n - Leukocytes >= 3,000/mcL\r\n\r\n - Hemoglobin >= 10 g/dL with no blood transfusion in the past 28 days\r\n\r\n - Absolute neutrophil count >= 1,500/mcL\r\n\r\n - Platelets >= 100,000/mcL\r\n\r\n - Total bilirubin within normal institutional limits\r\n\r\n - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase\r\n [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])\r\n =< 3 x institutional upper limit of normal\r\n\r\n - Creatinine =< the institutional upper limit of normal OR creatinine clearance >= 60\r\n mL/min/1.73 m^2 for patients with creatinine levels above institutional normal\r\n\r\n - Corrected QT using Fridericia's formula (QTcF) =< 450 ms\r\n\r\n - Any clinically significant electrolyte imbalance, particularly hypokalemia and\r\n hypomagnesemia, should be corrected before treatment\r\n\r\n - Pre-study evaluation must include an ophthalmologic exam by an ophthalmologist (not\r\n optometrist) and should minimally include visual acuity testing, slit lamp\r\n examination, and funduscopic examination; follow up eye-exams will only be performed\r\n if subjects develop/report any visual impairment; visual impairment may include\r\n peripheral flashes (photopsia), blurred or double vision, floaters, color distortion\r\n and dimness, difficulties with light/dark accommodation, tunnel vision or other field\r\n defects, halos, apparent movement of stationary objects, and complex disturbances;\r\n follow up eye-exams will minimally include visual acuity testing, slit lamp\r\n examination, and funduscopic examination; additional testing will be based on\r\n symptoms, what is observed and ophthalmologist recommendations\r\n\r\n - For the expansion cohort only: measurable disease by RECIST v1.1 with at least one\r\n measurable target lesion\r\n\r\n - The effects of olaparib in combination with AT13387on the developing human fetus are\r\n unknown; for this reason and because olaparib and AT13387 are anti-neoplastic small\r\n molecule inhibitors, which are agents that are potentially teratogenic, women of\r\n child-bearing potential and men must agree to use adequate contraception (hormonal or\r\n barrier method of birth control; abstinence) prior to study entry, for the duration of\r\n study participation, and for 3 months after the last dose of study drugs; should a\r\n woman become pregnant or suspect she is pregnant while she or her partner is\r\n participating in this study, she should inform her treating physician immediately; men\r\n treated or enrolled on this protocol must also agree to use adequate contraception\r\n prior to the study, for the duration of study participation, and 4 months after\r\n completion of olaparib and/or AT13387 administration\r\n\r\n - Patients must be able to swallow tablets and have no significant impairment in\r\n gastrointestinal absorption\r\n\r\n - Ability to understand and the willingness to sign a written informed consent document\r\n\r\n Exclusion Criteria:\r\n\r\n - Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for\r\n nitrosoureas or mitomycin C) prior to entering the study or those who have not\r\n recovered from adverse events due to agents administered more than 4 weeks earlier\r\n\r\n - All acute, clinically significant treatment-related toxicity from prior therapy,\r\n except for alopecia, must have resolved to grade =< 1\r\n\r\n - Patients who are receiving any other investigational agents\r\n\r\n - Patients with known active or history of brain metastases should be excluded from this\r\n clinical trial because of their poor prognosis and because they often develop\r\n progressive neurologic dysfunction that would confound the evaluation of neurologic\r\n and other adverse events\r\n\r\n - History of allergic reactions attributed to compounds of similar chemical or biologic\r\n composition to olaparib and AT13387 used in study\r\n\r\n - Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n study requirements\r\n\r\n - Pregnant women are excluded from this study because olaparib and AT13387 are agents\r\n with the potential for teratogenic or abortifacient effects; because there is an\r\n unknown but potential risk for adverse events in nursing infants secondary to\r\n treatment of the mother with AT13387 or olaparib, breastfeeding should be discontinued\r\n if the mother is treated with olaparib or AT13387\r\n\r\n - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral\r\n therapy are ineligible because of the potential for pharmacokinetic interactions with\r\n olaparib or AT13387; in addition, these patients are at increased risk of lethal\r\n infections when treated with marrow-suppressive therapy; appropriate studies will be\r\n undertaken in patients receiving combination antiretroviral therapy when indicated\r\n\r\n - Known history of QT/corrected QT (QTc) prolongation or torsades de pointes (TdP);\r\n patients who are currently receiving treatment with medication with a known risk to\r\n prolong the QT interval or inducing torsades de pointes and the treatment cannot\r\n either be discontinued or switched to a different medication prior to starting study\r\n drugs\r\n\r\n - Participants receiving any medications or substances that are strong inhibitors or\r\n inducers of CYP3A4 or moderate inhibitors of CYP3A4 are ineligible; the study team\r\n should check a frequently-updated medical reference for a list of drugs to avoid or\r\n minimize use of; as part of the enrollment/informed consent procedures, the patient\r\n will be counseled on the risk of interactions with other agents, and what to do if new\r\n medications need to be prescribed or if the patient is considering a new\r\n over-the-counter medicine or herbal product\r\n\r\n - Participants with myelodysplastic syndrome/acute myeloid leukemia or with features\r\n suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Olaparib', 'Onalespib']\n- **Description:** ['Given PO', 'Given IV']\n- **Mesh Terms:** ['Olaparib', 'Poly(ADP-ribose) Polymerase Inhibitors']\nSMILES: ['FC1=CC=C(CC2=NNC(=O)C3=CC=CC=C23)C=C1C(=O)N1CCN(CC1)C(=O)C1CC1', 'CC(C)C1=CC(C(=O)N2CC3=CC=C(CN4CCN(C)CC4)C=C3C2)=C(O)C=C1O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT01730118
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nAd/HER2/Neu Dendritic Cell Cancer Vaccine Testing\n\n**Trial Summary:** \n\n\n Background:\r\n\r\n - Human epidermal growth factor receptor 2 (HER2, also known as c-erbB2 or neu)/neu (HER2) is\r\n a tumor protein that appears in almost a third of breast cancers and in several other types\r\n of cancers such as colon, prostate and non-small cell lung. Tumors that overexpress HER2 can\r\n be associated with a more aggressive cancer, higher recurrence rates, and reduced survival\r\n rates. Researchers are testing a therapeutic cancer vaccine designed to stimulate the immune\r\n system to recognize HER2. The vaccine, called adenoviral transduced autologous human\r\n epidermal growth factor receptor (AdHER)/neu dendritic cell vaccine, is custom-made using an\r\n individual's own immune cells. These cells will be collected and used to produce the vaccine.\r\n\r\n Objectives:\r\n\r\n - To test the safety and effectiveness of AdHER2 vaccination.\r\n\r\n Eligibility:\r\n\r\n - Individuals at least 18 years of age who have HER2-expressing tumors.\r\n\r\n Design:\r\n\r\n - Participants will be screened with a physical exam and medical history. Blood and urine\r\n samples will be collected. Imaging studies will also be performed.\r\n\r\n - Participants will have an apheresis procedure to collect immune cells to create the\r\n vaccine.\r\n\r\n - Participants will receive five doses of the vaccine at study Weeks 0, 4, 8, 16 and 24.\r\n\r\n - Participants will be monitored with physical exams, frequent blood tests and imaging\r\n studies.\r\n \n\n**Trial Keywords:** ['Metastatic Solid Tumors', 'Human Epidermal Growth Factor Receptor 2 Expression (HER2/neu)', 'Trastuzumab Exposure', 'Dendritic Cell Vaccine', 'Breast Cancer']\n\n**Phase:** Phase 1\n\n**Condition:** ['Breast Neoplasms', 'Breast Cancer', 'Adenocarcinomas', 'Metastatic Solid Tumors Characterized by HER2/Neu Expression']\n\n**Condition Keywords:** Breast Neoplasms\n\n**ICD Code:** [\"['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']\", \"['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n - ELIGIBILITY CRITERIA:\r\n\r\n Common Eligibility for Parts I and II\r\n\r\n - Adults greater than or equal to 18 with malignant soft tissue and bone tumors and\r\n recurrent or progressive, metastatic solid tumors who have progressed on standard\r\n therapies except in adjuvant for high risk bladder cancer in Part I.\r\n\r\n - Recurrent or progressive disease on prior standard therapies with known clinical\r\n benefit with the exception of adjuvant bladder cancer population.\r\n\r\n - Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1.\r\n\r\n - Baseline left ventricular ejection fraction (LVEF) by two-dimensional (2D)\r\n Echocardiogram greater than or equal to 53%.\r\n\r\n - Greater than or equal to 1 week since standard or investigational treatment for\r\n metastatic disease.\r\n\r\n - Stable, concurrent use of hormone therapy for hormone receptor positive breast cancer\r\n is permitted.\r\n\r\n - Hematologic parameters: absolute neutrophil count (ANC) greater than or equal to 1000\r\n cells/mm^3, absolute lymphocyte count (ALC) greater than or equal to 300 cells/mm^3,\r\n Hemoglobin greater than or equal to 9.0 gm/dL, white blood cell (WBC) greater than or\r\n equal to 2,500 cells/mm^3, platelet count greater than or equal to 75,000/mm^3,\r\n prothrombin time (PT)/partial thromboplastin time (PTT) less than or equal to 1.5X the\r\n upper limits of normal.\r\n\r\n - Chemistry parameters: Creatinine less than or equal to 1.5 mg/dL, serum\r\n glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase\r\n (SGPT) less than or equal to 3X the upper limits of normal and total bilirubin less\r\n than or equal to 1.5 mg/dl, Alkaline phosphatase (Alk PO4) less than or equal to 3X\r\n the upper limits of normal (except for patients with documented metastatic disease to\r\n bone and/or liver).\r\n\r\n - Negative serum beta human chorionic gonadotropin (HCG) if female and of childbearing\r\n potential.\r\n\r\n - Negative human immunodeficiency virus (HIV) 1/2 serology and sample drawn for human\r\n T-cell lymphotropic virus (HTLV). Patients with HIV are excluded from participating on\r\n this clinical trial because their immunodeficiency would confound the evaluation of\r\n adverse events which would hinder meeting the primary objective.\r\n\r\n - Negative serology for hepatitis B and C unless the result is consistent with prior\r\n vaccination or prior infection with full recovery.\r\n\r\n - Willingness of female and male subjects to use effective contraception e.g., oral\r\n contraceptives, barrier device, intrauterine device, or condoms, during the study and\r\n for three months following the last dose of study vaccine. We suggest that subjects do\r\n not become pregnant or father a child during the study, and for 3 months following\r\n receipt of the investigational adenoviral transduced autologous human epidermal growth\r\n factor receptor (AdHER) dendritic cell (DC) vaccine.\r\n\r\n - Able to understand and provide Informed Consent.\r\n\r\n - Patients with 1+ to 3+ human epidermal growth factor receptor 2 (HER2)/neu expression\r\n by immunohistochemistry (IHC) or an equivocal or positive fluorescence in situ\r\n hybridization (FISH) result by 2013 American Society of Clinical Oncology\r\n (ASCO)/Corrective Action Plan (CAP) guideline.\r\n\r\n - Patients must have measurable disease, per Response Evaluation Criteria in Solid\r\n Tumors (RECIST) 1.1.\r\n\r\n Part I Eligibility\r\n\r\n - Naive to trastuzumab (Herceptin), pertuzumab (Perjeta) and lapatinib (Tykerb),\r\n ado-trastuzumab emtansine (Kadcyla) or other HER2-directed therapies.\r\n\r\n - Malignancy as follows:\r\n\r\n - Malignant soft tissue and bone tumors and recurrent or progressive, metastatic solid\r\n tumors who have progressed on standard therapies; or,\r\n\r\n - Bladder cancer in the adjuvant setting (adjuvant bladder cancer patients):\r\n\r\n - Tumor stage T3a, T3b, T4a, T4b and any node positive disease regardless of tumor\r\n stage.\r\n\r\n - Status-post primary cystectomy with curative intent.\r\n\r\n - May or may not have received neoadjuvant cisplatin-based combination chemotherapy\r\n per National Comprehensive Cancer Network (NCCN) guidelines.\r\n\r\n - May or may not have received adjuvant radiotherapy or chemotherapy based on\r\n pathologic risk per NCCN guidelines.\r\n\r\n - Greater than or equal to 6 weeks s/p primary surgery with curative intent.\r\n\r\n - NOTE: Patients with breast, ovarian, cervical, colon, gastric/gastroesophageal\r\n junction, non-small cell lung, renal cell, bladder, malignant soft tissue and bone\r\n tumor, prostate cancer or other solid tumors.\r\n\r\n Part II Eligibility\r\n\r\n - Malignant soft tissue and bone tumors and recurrent or progressive, metastatic solid\r\n tumors who have progressed on standard therapies.\r\n\r\n - Recurrent or progressive metastatic disease after standard of care HER2-targeted\r\n therapies, i.e., trastuzumab (Herceptin), pertuzumab (Perjeta), lapatinib (Tykerb),\r\n ado-trastuzumab emtansine (TDM1) (Kadcyla) or other HER2-directed therapies.\r\n\r\n - Stable, concurrent use of tamoxifen or aromatase inhibitors for hormone receptor\r\n positive breast cancer is permitted.\r\n\r\n EXCLUSION CRITERIA:\r\n\r\n - Pregnant women are excluded from this study because Adenoviral Transduced Autologous\r\n Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine may have\r\n the potential for teratogenic or abortifacient effects. Because there is an unknown\r\n but potential risk for adverse events in nursing infants secondary to treatment of the\r\n mother with AdHER DC vaccine, breastfeeding should be discontinued if the mother is\r\n treated with AdHER DC vaccine.\r\n\r\n - Patients with active central nervous system (CNS) metastases or leptomeningeal\r\n involvement by tumor (patients with a history of brain metastases who have\r\n successfully treated for brain metastasis by surgery or radiation and who have not had\r\n any evidence of the new or progressive CNS disease for more than 12 months are\r\n eligible).\r\n\r\n - Patients with rapidly progressing disease in the opinion of the Principal\r\n Investigator.\r\n\r\n - Patients with inadequate bilateral peripheral venous or central venous catheter access\r\n for the required apheresis to allow generation of the autologous AdHER2 DC vaccine\r\n product.\r\n\r\n - Clinically significant cardiac dysfunction defined as a history of > New York Heart\r\n Association (NYHA) Class II symptoms, angina, congestive heart failure, myocardial\r\n infarction, arrhythmias or cardiac dysfunction requiring treatment or discontinuation\r\n of chemotherapy.\r\n\r\n - History of changes in baseline LVEF that occurred during prior treatment with\r\n anti-HER2 treatment.\r\n\r\n - Cumulative doxorubicin dose > 400mg/m^2 (>450 mg/m^2 for malignant soft tissue and\r\n bone tumor patients) or cumulative epirubicin dose > 800mg/m^2.\r\n\r\n - Use of any standard chemotherapy or other investigational agent(s) within 1 week of\r\n study enrollment.\r\n\r\n - Use of systemic corticosteroid therapy within 2 weeks of study enrollment, including\r\n patients receiving replacement corticosteroid therapy. Note: only topical, inhaled and\r\n intranasal steroid therapy is permitted.\r\n\r\n - Active systemic viral, bacterial or fungal infection requiring treatment.\r\n\r\n - A medical history which the treating physician believes causes the patient to be\r\n excluded. This includes a remote history of cancer. Please note: Squamous cell\r\n carcinoma, basal cell carcinoma and remote history of cancer with no evidence of\r\n recurrence for the past 5 years are eligible.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Adenoviral Transduced Autologous Human Epidermal Growth Factor Receptor (AdHER)2/neu Dendritic Cell (DC) Vaccine\n- **Description:** autologous AdHER2 transduced dendritic cell vaccine manufactured under Good Manufacturing Practices (GMP) conditions from cryopreserved patient monocytes here at the National Institutes of Health (NIH) Clinical Center (CC) Department of Transfusion Medicine (DTM). Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16 and 24 of the study.\n- **Mesh Terms:** Mitogens\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03136380
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nStudy of Danirixin in Japanese Healthy Elderly Male Subjects\n\n**Trial Summary:** \n\n\n Danirixin is a selective chemokine receptor antagonist being developed as a potential\r\n anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD).\r\n The aim of the study is to assess the safety, tolerability and pharmacokinetics (PK) in\r\n healthy Japanese subjects over the age of 65 years (inclusive). The study will be conducted\r\n in two parts: Part 1 will be a double blind, placebo-controlled, 3-period crossover,\r\n ascending single oral dose administration of GSK1325756H (Hydrobromide Salt Tablet\r\n Formulations of Danirixin) 10, 50 and 100 milligram (mg) in the fed condition. Part 2 will be\r\n an open label, 2-period crossover, single oral dose of GSK1325756H 50 mg in fed and fasted\r\n state. This study will provide an understanding of PK of hydrobromide salt of GSK1325756 in\r\n population of healthy elderly subjects and also contribute to the selection of appropriate\r\n dosing for Phase IIa study in Japan.\r\n \n\n**Trial Keywords:** ['healthy Japanese subjects', 'CXCR2 inhibitor', 'Danirixin']\n\n**Phase:** Phase 1\n\n**Condition:** Pulmonary Disease, Chronic Obstructive\n\n**Condition Keywords:** Pulmonary Disease, Chronic Obstructive\n\n**ICD Code:** [\"['J44.9', 'J44.89', 'J44.1', 'J44.0']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 65 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria\r\n\r\n - Participant must be over 65 years of age inclusive, at the time of signing the\r\n informed consent.\r\n\r\n - Participants who are overtly healthy as determined by medical evaluation including\r\n medical history, physical examination, laboratory tests, and ECG. A subject with a\r\n clinical abnormality or laboratory parameter(s) which is/are not specifically listed\r\n in the inclusion or exclusion criteria, outside the reference range for the population\r\n being studied may be included only if the investigator in consultation with the\r\n Medical Monitor if required agree that the finding is unlikely to introduce additional\r\n risk factors and will not interfere with the study procedures.\r\n\r\n - Participants whose peripheral blood neutrophil counts and hematocrit values are within\r\n normal range at screening visit.\r\n\r\n - Body weight >=50 kilogram (Kg) and body mass index (BMI) within the range 18.5-24.9\r\n kg/square meter (m^2) (inclusive).\r\n\r\n - Japanese Male: A male participant must agree to use contraception during the treatment\r\n period and until follow up visit.\r\n\r\n - Capable of giving signed informed consent.\r\n\r\n Exclusion Criteria\r\n\r\n - History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,\r\n endocrine, hematological, or neurological disorders capable of significantly altering\r\n the absorption, metabolism, or elimination of drugs; constituting a risk when taking\r\n the study treatment; or interfering with the interpretation of data.\r\n\r\n - Abnormal blood pressure as determined by the investigator.\r\n\r\n - Alanine Aminotransferase (ALT)>1.5x upper limit of normal (ULN).\r\n\r\n - Bilirubin>1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is\r\n fractionated and direct bilirubin < 35%).\r\n\r\n - Current or chronic history of liver disease, or known hepatic or biliary abnormalities\r\n (with the exception of Gilbert's syndrome or asymptomatic gallstones).\r\n\r\n - QT interval corrected for heart rate according to Fridericia's formula (QTcF)> 450\r\n millisecond (msec).\r\n\r\n - Past or intended use of over-the-counter or prescription medication including herbal\r\n medications and proton pump inhibitor (PPI) within 14 days prior to dosing.\r\n\r\n - History of donation of blood or blood products >=400 milliliter (mL) within 3 months\r\n or >=200 mL within 1 month prior to screening.\r\n\r\n - Exposure to more than 4 new chemical entities within 12 months prior to the first\r\n dosing day.\r\n\r\n - Current enrolment or past participation within the last 30 days before signing of\r\n consent in this clinical study involving an investigational study treatment or any\r\n other type of medical research.\r\n\r\n - The subject with positive Serological test for syphilis (Rapid Plasma Reagin [RPR] and\r\n Treponema pallidum hemagglutination test [TPHA]), Human immunodeficiency virus (HIV)\r\n Antigen/Antibody, Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV)\r\n antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1) antibody at screening.\r\n\r\n - Positive pre-study drug screen.\r\n\r\n - Regular alcohol consumption within 6 months prior to the study defined as: an average\r\n weekly intake of > 14 units for males. One unit is equivalent to 350 mL of beer, 150\r\n mL of wine or 45 mL of 80 proof distilled spirits.\r\n\r\n - Smoking or history or regular use of tobacco- or nicotine-containing products within 6\r\n months prior to screening.\r\n\r\n - Sensitivity to any of the study treatments, or components thereof, or drug or other\r\n allergy that, in the opinion of the investigator or medical monitor, contraindicates\r\n participation in the study.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['GSK1325756H', 'Placebo']\n- **Description:** ['Danirixin will be available as 10 and 50 milligram (mg) white film coated, round and oval tablets intended for oral administration. It will be administered with 240 mL of water.', 'Subjects will receive visually matching danirixin placebo tablets. It will be administered with 240 mL of water.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02968914
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nPharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers\n\n**Trial Summary:** \n\n\n An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable\r\n drug exposure following Subcutaneous benralizumab administration by using accessorized\r\n pre-filled syringe (APFS) or autoinjector (AI) devices.\r\n \n\n**Trial Keywords:** ['Asthma', 'Chronic Obstructive pulmonary Disease', 'Pharmacokinetics', 'Healthy volunteers']\n\n**Phase:** Phase 1\n\n**Condition:** ['Asthma', 'Chronic Obstructive Pulmonary Disease']\n\n**Condition Keywords:** ['Lung Diseases', 'Lung Diseases, Obstructive', 'Pulmonary Disease, Chronic Obstructive']\n\n**ICD Code:** [\"['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']\", \"['J44.9', 'J44.89', 'J44.1', 'J44.0']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Healthy male and/or female subjects of non-child-bearing potential aged 18 to 55 years\r\n (inclusive) with suitable veins for cannulation or repeated venipuncture.\r\n\r\n - Females must be non pregnant,non lactating and non-child-bearing potential, confirmed\r\n at screening\r\n\r\n - Sexually active male willingness to use contraception\r\n\r\n - Body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weigh at least 55 kg and\r\n no more than 100 kg inclusive.\r\n\r\n Exclusion Criteria:\r\n\r\n - History of any clinically significant disease, severe allergy/anaphylaxis to any\r\n biologic therapy, Guillain-Barré syndrome, smoking and alcohol or drug abuse\r\n\r\n - Diagnosis of helminth parasitic infection and acute upper or lower respiratory\r\n infections\r\n\r\n - Disorders related to cardiovascular, gastrointestinal, hepatic, renal, neurological,\r\n musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or\r\n major physical impairment\r\n\r\n - Alanine aminotransferase/aspartate aminotransferase level ≥1.5 times the upper limit\r\n of normal\r\n\r\n - White blood cell count and neutrophils < lower limit of normal\r\n\r\n - Any clinically significant illness, medical/surgical procedure, or trauma within 4\r\n weeks of the first administration of Investigational medicinal product (IMP)\r\n\r\n - Positive result for serum hepatitis B surface antigen or anti-Hemoglobin C (anti-HBc)\r\n antibody, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.\r\n\r\n - Intake of new chemical entity (not been approved for marketing) within 3 months of the\r\n first administration of investigational product\r\n\r\n - Plasma donation within 1 month of screening or any blood donation/loss more than 500\r\n mL during the 3 months prior to screening\r\n\r\n - Receipt of immunoglobulin or blood products within 30 days prior to the date informed\r\n consent\r\n\r\n - Receipt of any marketed (e.g., omalizumab, mepolizumab etc.) or investigational\r\n biologic within 4 months or 5 half-lives prior to the date informed consent\r\n\r\n - Receipt of live attenuated vaccines 30 days prior to randomization on Day 1\r\n\r\n - Current malignancy, or history of malignancy except (basal cell carcinoma, localized\r\n squamous cell carcinoma of the skin or in situ carcinoma of the cervix)\r\n\r\n - Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks\r\n prior to the first administration of IMP.\r\n\r\n - Use of antacids, analgesics (except paracetamol/acetaminophen), herbal remedies,\r\n mega-dose vitamins (20 to 600 times the recommended daily dose) and minerals during\r\n the 2 weeks prior to the first administration of IMP or longer\r\n\r\n - Previous receipt of received benralizumab\r\n\r\n - Any ongoing or recent minor medical complaints\r\n\r\n - Vulnerable subjects, e.g., kept in detention, protected adults under guardianship,\r\n trusteeship, or committed to an institution by governmental or juridical order\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Benralizumab', 'Benralizumab']\n- **Description:** ['A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.', 'A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.']\n- **Mesh Terms:** Benralizumab\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02976519
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nBI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects\n\n**Trial Summary:** \n\n\n The objective of this study is to investigate the safety, tolerability, and pharmacokinetics\r\n of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Cystic Fibrosis\n\n**Condition Keywords:** Cystic Fibrosis\n\n**ICD Code:** [\"['E84.9', 'Z14.1', 'E84.0', 'E84.11', 'E84.8', 'E84.19', 'P09.4']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion criteria:\r\n\r\n Healthy volunteers:\r\n\r\n - Signed informed consent\r\n\r\n - Healthy male or female subjects\r\n\r\n - - Women of childbearing potential (WOCBP) should only be dosed after a confirmed\r\n menstrual period and/or with a progesterone level at Day -5 to Day -3 that\r\n demonstrates a dip from baseline, indicating a menstrual bleed prior to dosing.\r\n\r\n - Age of 18 to 55 years (incl.)\r\n\r\n - Body mass index (BMI) of 18.5 to 32.0 kg/m2 (incl.)\r\n\r\n - Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) of equal\r\n or greater than 80% of predicted normal, at screening and prior to randomisation\r\n\r\n Cystic Fibrosis (Cross over part):\r\n\r\n - Signed informed consent\r\n\r\n - Males or females with a documented diagnosis of cystic fibrosis\r\n\r\n - Women of childbearing potential (WOCBP) should only be dosed after a confirmed\r\n menstrual period and/or with a progesterone level at Day -5 to Day -3, that\r\n demonstrates a dip from baseline, indicating a menstrual bleed prior to dosing. For CF\r\n subjects of child bearing potential this must confirmed prior to second treatment\r\n period.\r\n\r\n - Age 18 to 55 years (each inclusive)\r\n\r\n - BMI of 18 to 32.0 kg/m2 (incl.)\r\n\r\n - Pre-bronchodilator FEV1 >/= to 70% of predicted normal at screening and prior to\r\n randomisation\r\n\r\n - Clinical stability as defined by no evidence of acute upper or lower respiratory tract\r\n infection; no pulmonary exacerbation requiring use of i.v. / oral / inhaled\r\n antibiotics, or oral corticosteroids; no change in pulmonary disease therapy; if on\r\n cycling antibiotics, these must be initiated within 2 weeks prior to randomisation; no\r\n acute (serious or non-serious) illness not related to cystic fibrosis; no infection\r\n with an organism associated with more rapid decline in pulmonary function (eg,\r\n Burkholderia cenocepacia, B dolosa, or Mycobacterium abscessus).\r\n\r\n - Able to perform technically acceptable pulmonary functions test (PFTs)\r\n\r\n - Further inclusion criteria apply.\r\n\r\n Exclusion criteria:\r\n\r\n - Any evidence of a concomitant disease judged as clinically relevant by the\r\n investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular,\r\n metabolic, immunological, dermatologic, hematologic, neurological and psychiatric,\r\n oncological, coagulation or hormonal disorders as determined by medical history,\r\n examination, and clinical investigations at screening that may, in the opinion of the\r\n investigator, result in any of the following:\r\n\r\n - Put the subject at risk because of participation in the study.\r\n\r\n - Influence the results of the study.\r\n\r\n - Cast doubt on the subject's ability to participate in the study.\r\n\r\n - Chronic or relevant acute infections.\r\n\r\n - History of relevant orthostatic hypotension, fainting spells, or blackouts\r\n\r\n - History of myocardial infarction; history of acute coronary syndrome\r\n\r\n - History of and/or active life-threatening cardiac arrhythmia, as assessed by the\r\n investigator\r\n\r\n - Major surgery (major according to the investigator's assessment)\r\n\r\n - History of chronic kidney disease (estimate glomerular filtration rate (EGFR) <59\r\n mls/min including corrections as per ethnicity)\r\n\r\n - History of relevant allergy or hypersensitivity (including allergy to the trial\r\n medication or its excipients)\r\n\r\n - Unsuitable veins for venipuncture (for instance, veins which are difficult to locate,\r\n access or puncture, veins with a tendency to rupture during or after puncture) as\r\n assessed by the investigator\r\n\r\n - Any finding in the medical examination (including blood pressure (BP), pulse rate (PR)\r\n or electrocardiogram (ECG) is deviating from normal and judged as clinically relevant\r\n by the investigator\r\n\r\n - Any laboratory value outside the reference range that the investigator considers to be\r\n of clinical relevance, specifically volunteers with serum potassium > upper limit of\r\n normal should be excluded; Safety laboratory screening and Day -7 to Day -3,\r\n evaluation can be repeated twice during screening.\r\n\r\n - For healthy volunteers, repeated measurement (i.e. > 2 measurements) of systolic blood\r\n pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the\r\n range of 50 to 90 mmHg. Volunteers will be excluded with a pulse rate outside the\r\n range of 45 to 90 bpm.\r\n\r\n - A marked baseline prolongation of mean QT/QTcF interval (such as QTcF intervals that\r\n are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in\r\n females) or any other relevant ECG finding at screening or prior to randomisation\r\n\r\n - A history of additional risk factors for Torsades de Pointes (such as heart failure,\r\n hypokalemia, or family history of Long QT Syndrome).\r\n\r\n - Within 10 days prior to administration of trial medication, use of drugs that might\r\n reasonably influence the results of the trial or that might prolong the QT/QTcF\r\n interval\r\n\r\n - Intake of drugs with a long half-life (more than 24hrs) within 30 days or less than 10\r\n half-lives of the respective drug prior to administration of trial medication unless\r\n this is allowed medications.\r\n\r\n - CF subjects treated with non-permitted concomitant medication. Specifically\r\n medications causing changes in serum potassium are restricted\r\n\r\n - Current or previous participation in another interventional trial, including where an\r\n investigational drug has been or will be administered within 60 days or 5 half-lives\r\n (whichever is longer) prior to screening\r\n\r\n - For healthy volunteers and CF subjects: current smokers or ex-smokers of less than 12\r\n months and/or with a pack year history of more than 5 years\r\n\r\n - Further exclusion criteria apply\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['BI 443651', 'Placebo']\n- **Description:** ['twice daily', 'twice daily']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02541565
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nPembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Diffuse Large B-cell Lymphoma or Grade 3b Follicular Lymphoma\n\n**Trial Summary:** \n\n\n This pilot phase I trial studies the side effects of pembrolizumab and combination\r\n chemotherapy in treating patients with previously untreated diffuse large B-cell lymphoma or\r\n grade 3b follicular lymphoma. Monoclonal antibodies, such as pembrolizumab and rituximab, may\r\n interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,\r\n such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone,\r\n work in different ways to stop the growth of cancer cells, either by killing the cells, by\r\n stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab\r\n together with combination chemotherapy may be with a better treatment for diffuse large\r\n B-cell lymphoma or follicular lymphoma.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Composite Lymphoma', 'Grade 3b Follicular Lymphoma', 'Stage I Diffuse Large B-Cell Lymphoma', 'Stage I Follicular Lymphoma', 'Stage II Diffuse Large B-Cell Lymphoma', 'Stage II Follicular Lymphoma', 'Stage III Diffuse Large B-Cell Lymphoma', 'Stage III Follicular Lymphoma', 'Stage IV Diffuse Large B-Cell Lymphoma', 'Stage IV Follicular Lymphoma']\n\n**Condition Keywords:** ['Lymphoma', 'Lymphoma, Follicular', 'Lymphoma, B-Cell', 'Lymphoma, Large B-Cell, Diffuse', 'Composite Lymphoma']\n\n**ICD Code:** [\"['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Previously untreated diffuse large B-cell lymphoma or grade 3B follicular lymphoma (of\r\n any stage); subjects must be planned to receive full course (6 cycles) of RCHOP\r\n chemoimmunotherapy as per clinical standard of care; patients may have de novo DLBCL,\r\n and /or any of the following:\r\n\r\n - Composite lymphomas, which include both diffuse DLBCL and another histology (most\r\n commonly follicular lymphoma) in the same lymph node\r\n\r\n - Transformed lymphoma with DLBCL histology, as long as the patient has not\r\n received prior therapy for lymphoma\r\n\r\n - Discordant presentations, such as DLBCL in a lymph node and low-grade lymphoma\r\n such as follicular lymphoma in the bone marrow\r\n\r\n - Be willing and able to provide written informed consent/assent for the trial\r\n\r\n - Have measurable nodal disease, including at least 1 disease site measuring 1.5 cm in\r\n longest dimension on computed tomography (CT) or fludeoxyglucose (FDG)-positron\r\n emission tomography (PET)\r\n\r\n - Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)\r\n performance scale (PS)\r\n\r\n - Absolute neutrophil count (ANC) >= 1,500/mcL except in cases of marrow infiltration by\r\n lymphoma\r\n\r\n - Platelets >= 100,000/mcL except in cases of marrow infiltration by lymphoma\r\n\r\n - Hemoglobin >= 9 g/dL or >= 5.6 mmol/L except in cases of marrow infiltration by\r\n lymphoma\r\n\r\n - Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated\r\n creatinine clearance >= 60 ml/min for subject with creatinine levels > 1.5 X\r\n institutional ULN (glomerular filtration rate [GFR] can also be used in place of\r\n creatinine or creatinine clearance [CrCl])\r\n\r\n - Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total\r\n bilirubin levels > 1.5 ULN\r\n\r\n - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase\r\n [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])\r\n =< 2.5 X ULN or =< 5 X ULN for subjects with liver metastases\r\n\r\n - International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless\r\n subject is receiving anticoagulant therapy; as long as PT or partial thromboplastin\r\n time (PTT) is within therapeutic range of intended use of anticoagulants; activated\r\n partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving\r\n anticoagulant therapy; as long as PT or PTT is within therapeutic range of intended\r\n use of anticoagulants, or subject is shown to have an antiphospholipid antibody on\r\n workup\r\n\r\n - Female subject of childbearing potential should have a negative urine or serum\r\n pregnancy within 72 hours prior to receiving the first dose of study medication; if\r\n the urine test is positive or cannot be confirmed as negative, a serum pregnancy test\r\n will be required\r\n\r\n - Female subjects of childbearing potential should be willing to use 2 methods of birth\r\n control or be surgically sterile, or abstain from heterosexual activity for the course\r\n of the study through 120 days after the last dose of study medication; subjects of\r\n childbearing potential are those who have not been surgically sterilized or have not\r\n been free from menses for > 1 year\r\n\r\n - Male subjects should agree to use an adequate method of barrier contraception starting\r\n with the first dose of study therapy through 120 days after the last dose of study\r\n therapy\r\n\r\n Exclusion Criteria:\r\n\r\n - Is currently participating and receiving study therapy or has participated in a study\r\n of an investigational agent and received study drug or using an investigation device\r\n within 4 weeks of the first dose of treatment\r\n\r\n - Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any\r\n other form of immunosuppressive therapy within 7 days prior to the first dose of trial\r\n treatment\r\n\r\n - Has a known additional malignancy that is progressing or requires active treatment;\r\n exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the\r\n skin, or in situ cervical cancer that has undergone potentially curative therapy\r\n\r\n - Has known active central nervous system (CNS) metastases and/or carcinomatous\r\n meningitis; subjects with previously treated brain metastases may participate provided\r\n they are stable (without evidence of progression by imaging for at least four weeks\r\n prior to the first dose of trial treatment and any neurologic symptoms have returned\r\n to baseline), have no evidence of new or enlarging brain metastases, and are not using\r\n steroids for at least 7 days prior to trial treatment\r\n\r\n - No active autoimmune disease that has required systemic treatment in past 2 years\r\n (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive\r\n drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid\r\n replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r\n form of systemic treatment\r\n\r\n - Has history of non-infectious pneumonitis that required steroids or current\r\n pneumonitis\r\n\r\n - Has an active infection requiring intravenous antibiotic therapy\r\n\r\n - Has a history or current evidence of any condition, therapy, or laboratory abnormality\r\n that might confound the results of the trial, interfere with the subject's\r\n participation for the full duration of the trial, or is not in the best interest of\r\n the subject to participate, in the opinion of the treating investigator\r\n\r\n - Has known psychiatric or substance abuse disorders that would interfere with\r\n cooperation with the requirements of the trial\r\n\r\n - Is pregnant or breastfeeding, or expecting to conceive or father children within the\r\n projected duration of the trial, starting with the pre-screening or screening visit\r\n through 120 days after the last dose of trial treatment\r\n\r\n - Has received prior therapy with an anti-PD-1, anti-programmed cell death ligand 1\r\n (PD-L1), anti-programmed cell death ligand 2 (PD-L2), anti-tumor necrosis factor\r\n receptor superfamily, member 9 (CD137), or anti-cytotoxic T-lymphocyte-associated\r\n antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug\r\n specifically targeting T-cell co-stimulation or checkpoint pathways)\r\n\r\n - Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)\r\n\r\n - Has known active hepatitis B (e.g., hepatitis B virus surface protein antigen [HBsAg]\r\n reactive or hepatitis B virus [HBV] deoxyribonucleic acid [DNA] detectable) or\r\n hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is\r\n detected)\r\n\r\n - Has received a live vaccine within 30 days prior to the first dose of trial treatment\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Cyclophosphamide', 'Doxorubicin Hydrochloride', 'Laboratory Biomarker Analysis', 'Pembrolizumab', 'Prednisone', 'Rituximab', 'Vincristine Sulfate']\n- **Description:** ['Given IV', 'Given IV', 'Correlative studies', 'Given IV', 'Given PO', 'Given IV', 'Given IV']\n- **Mesh Terms:** ['Prednisone', 'Cortisone', 'Cyclophosphamide', 'Rituximab', 'Doxorubicin', 'Liposomal doxorubicin', 'Pembrolizumab', 'Vincristine', 'Antineoplastic Agents, Immunological', 'Antibodies', 'Immunoglobulins', 'Antibodies, Monoclonal']\nSMILES: ['ClCCN(CCCl)P1(=O)NCCCO1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', '[H][C@@]12N3CC[C@@]11C4=C(C=C(OC)C(=C4)[C@]4(C[C@H]5C[N@](C[C@](O)(CC)C5)CCC5=C4NC4=CC=CC=C54)C(=O)OC)N(C=O)[C@@]1([H])[C@](O)([C@H](OC(C)=O)[C@]2(CC)C=CC3)C(=O)OC']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02563548
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid Tumors\n\n**Trial Summary:** \n\n\n This is a Phase 1b study evaluating a combination of PEGPH20 and pembrolizumab in\r\n hyaluronan-high (HA-high) participants with relapsed/refractory non-small cell lung cancer\r\n (NSCLC) and HA-high participants with relapsed/refractory gastric adenocarcinoma (GAC).\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['NSCLC', 'Gastric Cancer']\n\n**Condition Keywords:** Stomach Neoplasms\n\n**ICD Code:** ['None', \"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Dose Expansion: Histologically confirmed and documented, previously untreated or\r\n treated stage IIIB or IV NSCLC having failed no more than 1 previous platinum\r\n containing chemotherapy regimen for locally-advanced or metastatic disease or\r\n relapsed/refractory locally advanced or metastatic gastric adenocarcinoma having\r\n failed no more than 2 previous chemotherapy regimens for locally advanced or\r\n metastatic disease. Participants with NSCLC who are known to be epidermal growth\r\n factor receptor (EGFR)-mutation positive must have received an EGFR inhibitor and\r\n participants known to be anaplastic lymphoma kinase (ALK)-mutation positive must have\r\n received an ALK inhibitor.\r\n\r\n Prior to enrollment, confirmation of the following must be obtained:\r\n\r\n • For participants in the dose expansion portion of the study, it is mandatory that\r\n available archived tumor tissue in formalin-fixed.\r\n\r\n paraffin-embedded (FFPE) block or minimum 10-15 unstained consecutive core biopsy slides\r\n from 1 archival block that meet specific tissue requirements are available.\r\n\r\n - For dose expansion: one or more tumors measurable on computed tomography (CT)\r\n scan/magnetic resonance imaging (MRI) scan per RECIST v 1.1., for dose escalation,\r\n participants need only have evaluable disease - Previously irradiated tumors may be\r\n eligible if they have clearly progressed in size.\r\n\r\n - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\r\n\r\n - Life expectancy greater than or equal to (≥) 3 months.\r\n\r\n Participants must also satisfy the following inclusion criterion to be enrolled in the dose\r\n expansion portion:\r\n\r\n - Participants (NSCLC and gastric adenocarcinoma) must be determined to have HA-high\r\n levels from their tumor biopsies.\r\n\r\n - NSCLC and gastric adenocarcinoma participants must have tissue available for\r\n HA-selection and programmed cell death-1 (PD-L1) testing.\r\n\r\n Exclusion Criteria:\r\n\r\n - Previous treatment with pembrolizumab, nivolumab, or other antibody (anti-)-PD-1 or\r\n PD-1 ligand-antibody (anti-PD-L1) agents.\r\n\r\n - New York Heart Association Class III or IV (Appendix D) cardiac disease or myocardial\r\n infarction within the past 12 months before screening, or preexisting atrial\r\n fibrillation.\r\n\r\n - Prior history of cerebrovascular accident or transient ischemic attack.\r\n\r\n - NSCLC participants with known brain metastases (certain exceptions allowed)\r\n\r\n - Gastric adenocarcinoma participants with brain metastases\r\n\r\n - History of active bleeding within the last 3 months requiring transfusion\r\n\r\n - Anti-angiogenic therapy within the last month\r\n\r\n - Participants with known interstitial fibrosis or interstitial lung disease.\r\n\r\n - Previous history of pulmonary embolism or pulmonary embolism found on screening exam.\r\n\r\n - History of:\r\n\r\n 1. Pneumonitis that requires oral or IV steroids;\r\n\r\n 2. Or known cases of hepatobiliary diseases (e.g., primary biliary cholangitis,\r\n primary sclerosing cholangitis, history of immune-mediated cholangitis);\r\n\r\n - Participants with cholangitis attributed to infectious etiology (e.g.,\r\n ascending cholangitis, bacterial cholangitis) are eligible if the infection\r\n has been fully resolved prior to the screening visit.\r\n\r\n 3. Or known cases of drug-induced hepatobiliary toxicities.\r\n\r\n - Active autoimmune disease requiring systemic treatment within the past 3 months or\r\n documented history of clinically severe autoimmune disease, or syndrome that requires\r\n systemic steroids or immunosuppressive agents.\r\n\r\n - History of another primary cancer within the last 3 years that required treatment,\r\n with the exception of non-melanoma skin cancer, early-stage prostate cancer, or\r\n curatively treated cervical carcinoma in situ.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['PEGPH20', 'Pembrolizumab']\n- **Description:** ['PEGPH20 will be administered as an intravenous (IV) infusion as per the dose schedule specified in the arm description.', 'Pembrolizumab will be administered as an IV infusion as per the dose schedule specified in the arm description.']\n- **Mesh Terms:** Pembrolizumab\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02969317
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nBioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients\n\n**Trial Summary:** \n\n\n The primary objective of this study is to assess the pharmacokinetics of tiotropium +\r\n olodaterol fixed-dose combination (FDC) (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after\r\n single dose and at steady state in Chinese patients with COPD.\r\n\r\n The secondary objective is to assess the safety of tiotropium + olodaterol FDC (5 μg/ 5 μg)\r\n delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Chinese patients with\r\n COPD.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Pulmonary Disease, Chronic Obstructive\n\n**Condition Keywords:** ['Lung Diseases', 'Pulmonary Disease, Chronic Obstructive']\n\n**ICD Code:** [\"['J44.9', 'J44.89', 'J44.1', 'J44.0']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 40 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion criteria:\r\n\r\n - All patients must sign an informed consent consistent with International Conference on\r\n Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local legislations prior\r\n to any study-related procedures, which includes medication washout and restrictions.\r\n\r\n - All patients must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and\r\n must meet the following spirometric criteria:\r\n\r\n Patients must have relatively stable airway obstruction with a post-bronchodilator Forced\r\n Expiratory Volume in one second (FEV1) >=30% of predicted normal and <80% of predicted\r\n normal (ECSC,; and a postbronchodilator FEV1/ Forced Vital Capacity (FVC)<70% at Visit 1\r\n\r\n - Male or female patients, 40 years of age or older.\r\n\r\n - Patients must be current or ex-smokers with a smoking history of more than 10 pack\r\n years.\r\n\r\n Patients who have never smoked cigarettes must be excluded.\r\n\r\n - Patients must be able to\r\n\r\n - perform technically acceptable pulmonary function tests,\r\n\r\n - maintain medication worksheet records during the study period,\r\n\r\n - perform all other assessments as required in the protocol.\r\n\r\n - Patients must be able to inhale medication in a competent manner from the RESPIMAT\r\n inhaler and from a metered dose inhaler (MDI).\r\n\r\n - Male or female patients. Women of childbearing potential* must be ready and able to\r\n use highly effective methods of birth control per ICH M3(R2) that result in a low\r\n failure rate of less than 1% per year when used consistently and correctly. A list of\r\n contraception methods meeting these criteria is provided in the patient information.\r\n\r\n - Women of childbearing potential are defined as:\r\n\r\n Any female who has experienced menarche and does not meet the criteria for \"women not of\r\n childbearing potential\" as described below.\r\n\r\n Women not of childbearing potential are defined as:\r\n\r\n Women who are postmenopausal (12 months with no menses without an alternative medical\r\n cause) or who are permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral\r\n oophorectomy or bilateral salpingectomy).\r\n\r\n Exclusion criteria:\r\n\r\n - Patients with a significant disease other than Chronic Obstructive Pulmonary Disease\r\n (COPD); a significant disease is defined as a disease which, in the opinion of the\r\n investigator, may (i) put the patient at risk because of participation in the study,\r\n (ii) influence the results of the study, or (iii) cause concern regarding the\r\n patient's ability to participate in the study.\r\n\r\n - Patients with a, in the opinion of the investigator, clinically relevant abnormal\r\n baseline haematology, blood chemistry, or urinalysis; all patients with an Serum\r\n Glutamic Oxaloacetic Transaminase (SGOT) >x 2 Upper Limit of Normal (ULN), Serum\r\n Glutamic Pyruvic Transaminase(SGPT) >x 2 ULN, bilirubin >x 2 ULN or creatinine >x 2\r\n ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation\r\n will not be conducted in these patients).\r\n\r\n - Patients with a history of asthma. For patients with allergic rhinitis or atopy,\r\n source documentation is required to verify that the patient does not have asthma. If a\r\n patient has a total blood eosinophil count ≥600/mm3, source documentation is required\r\n to verify that the increased eosinophil count is related to a non-asthmatic condition.\r\n\r\n Patients with any of the following conditions:\r\n\r\n - A diagnosis of thyrotoxicosis (due to the known class side effect profile of\r\n ß2-agonists).\r\n\r\n - A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class\r\n side effect profile of ß2-agonists)\r\n\r\n - A history of myocardial infarction within 1 year of screening visit (Visit 1).\r\n\r\n - Unstable or life-threatening cardiac arrhythmia.\r\n\r\n - Hospitalization for heart failure within the past year.\r\n\r\n - Known active tuberculosis.\r\n\r\n - A malignancy for which patient has undergone resection, radiation therapy or\r\n chemotherapy within last five years (patients with treated basal cell carcinoma are\r\n allowed).\r\n\r\n - A history of life-threatening pulmonary obstruction.\r\n\r\n - A history of cystic fibrosis.\r\n\r\n - Clinically evident bronchiectasis.\r\n\r\n - A history of significant alcohol or drug abuse.\r\n\r\n - Patients who have undergone thoracotomy with pulmonary resection (patients with a\r\n history of thoracotomy for other reasons should be evaluated as per exclusion\r\n criterion No. 1).\r\n\r\n - Patients being treated with oral or patch β-adrenergics.\r\n\r\n - Patients being treated with oral corticosteroid medication at unstable doses (i.e.,\r\n less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg\r\n of prednisone per day or 20 mg every other day.\r\n\r\n - Patients who regularly use daytime oxygen therapy for more than one hour per day and\r\n in the investigator's opinion will be unable to abstain from the use of oxygen therapy\r\n during clinic visits.\r\n\r\n - Patients who have completed a pulmonary rehabilitation program in the six weeks prior\r\n to the screening visit (Visit 1) or patients who are currently in a pulmonary\r\n rehabilitation program.\r\n\r\n - Patients who have taken an investigational drug within one month or six half lives or\r\n within the wash out period (whichever is greater) prior to screening visit (Visit 1).\r\n\r\n - Patients with known hypersensitivity to β-adrenergics and/or anticholinergic drugs,\r\n benzalkonium chloride (BAC), disodium edentate (EDTA) or any other component of the\r\n RESPIMAT inhalation solution.\r\n\r\n - Women who are pregnant, nursing, or who plan to become pregnant while in the trial\r\n\r\n - Women of childbearing potential not using two highly effective methods of birth\r\n control*.\r\n\r\n Female patients will be considered to be of childbearing potential unless surgically\r\n sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two\r\n years.\r\n\r\n * as per ICH M3: a highly effective method of birth control is defined as those which\r\n result in a low failure rate (i.e., less than 1% per year) when used consistently and\r\n correctly.\r\n\r\n - Patients who have previously been allocated in this study or are currently\r\n participating in another study.\r\n\r\n - Patients who are unable to comply with pulmonary medication restrictions prior to\r\n allocation.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Tiotropium', 'Olodaterol']\n- **Description:** ['Fixed dose combination', 'Fixed dose combination']\n- **Mesh Terms:** ['Tiotropium Bromide', 'Olodaterol']\nSMILES: ['[H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1', 'COC1=CC=C(CC(C)(C)NC[C@H](O)C2=C3OCC(=O)NC3=CC(O)=C2)C=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03689192
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nArginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors\n\n**Trial Summary:** \n\n\n In this phase I first-in-humans-study a vaccine consisting of arginase-1 (ARG1) peptides and\r\n the adjuvant Montanide ISA-51 will be tested in ten patients with metastatic solid tumors.\r\n Patients will be treated with an ARG1 vaccine every third week for 45 weeks.\r\n \n\n**Trial Keywords:** Arginase 1\n\n**Phase:** Phase 1\n\n**Condition:** ['Non Small Cell Lung Cancer', 'Urothelial Carcinoma', 'Malignant Melanoma', 'Ovarian Cancer', 'Colorectal Cancer', 'Breast Cancer', 'Squamous Cell Carcinoma of the Head and Neck', 'Metastatic Cancer']\n\n**Condition Keywords:** ['Carcinoma', 'Melanoma', 'Squamous Cell Carcinoma of Head and Neck']\n\n**ICD Code:** [\"['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']\", \"['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']\", \"['C43.0', 'C43.31', 'C43.51', 'C43.9', 'C43.4', 'C43.52', 'C43.10']\", \"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\", \"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\", \"['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']\", \"['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']\", \"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Age ≥ 18\r\n\r\n 2. The patient has metastatic solid tumors (NSCLC, colorectal cancer, urothelial cancer,\r\n breast cancer, ovarian cancer, malignant melanoma or HNSCC); progressive or recurrent\r\n disease on or following treatment with standard of care agents\r\n\r\n 3. At least one measurable parameter according to RECIST 1.1.\r\n\r\n 4. The patient has an ECOG performance status of 0 or 1\r\n\r\n 5. Life expectancy of at least 3 months\r\n\r\n 6. Prior PD1/PD-L1 allowed\r\n\r\n 7. The patient is a female of childbearing potential with negative pregnancy test\r\n\r\n 8. For fertile women: Agreement to use contraceptive methods with a failure rate of < 1 %\r\n per year during the treatment period and for at least 150 days 12 weeks after the\r\n treatment. Safe contraceptive methods for women are birth control pills, intrauterine\r\n device, contraceptive injection, contraceptive implant, contraceptive patch or\r\n contraceptive vaginal ring.\r\n\r\n 9. For men: Agreement to use contraceptive measures and agreement to refrain from\r\n donating sperm\r\n\r\n 10. The patient has met the following hematological and biochemical criteria:\r\n\r\n 1. AST and ALT ≤2,5 X ULN or ≤5 X ULN with liver metastases\r\n\r\n 2. Serum total bilirubin ≤1,5 X ULN or direct bilirubin ≤ ULN for patient with total\r\n bilirubin level > 1,5 ULN\r\n\r\n 3. Serum creatinine ≤1,5 X ULN\r\n\r\n 4. ANC (Absolute Neutrophil Count) ≥1,000/mcL\r\n\r\n 5. Platelets ≥ 75,000 /mcL\r\n\r\n 6. Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L\r\n\r\n 11. Mandatory provision of archival tissue and blood for biomarker testing at baseline\r\n\r\n 12. Mandatory provision of blood for biomarker testing during the study\r\n\r\n 13. Signed declaration of consent after oral and written information about the protocol\r\n\r\n Exclusion Criteria:\r\n\r\n 1. The patient has not recovered from surgery or is less than 4 weeks from major surgery\r\n\r\n 2. The patient has a history of life-threatening or severe immune related adverse events\r\n on treatment with another immunotherapy and is considered to be at risk of not\r\n recovering\r\n\r\n 3. The patient is expected to require any other form of systemic antineoplastic therapy\r\n or radiation therapy while receiving the treatment. However, radiation therapy\r\n treatment of non target lesion is allowed.\r\n\r\n 4. The patient has a history of severe clinical autoimmune disease\r\n\r\n 5. The patient has a history of pneumonitis, organ transplant, human immunodeficiency\r\n virus positive, active hepatitis B or hepatitis C\r\n\r\n 6. The patient requires systemic steroids for management of immune-related adverse events\r\n experienced on another immunotherapy\r\n\r\n 7. The patient has any condition that will interfere with patient compliance or safety\r\n (including but not limited to psychiatric or substance abuse disorders)\r\n\r\n 8. The patient is pregnant or breastfeeding\r\n\r\n 9. The patient is unable to voluntarily agree to participate by signed informed consent\r\n or assent\r\n\r\n 10. The patient has an active infection requiring systemic therapy\r\n\r\n 11. The patient has received a live virus vaccine within 30 days of planned start of\r\n therapy\r\n\r\n 12. Significant medical disorder according to investigator; e.g. severe asthma or chronic\r\n obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus\r\n\r\n 13. Concurrent treatment with other experimental drugs\r\n\r\n 14. Concurrent treatment with Valproate or Xanthin Oxidase inhibitors\r\n\r\n 15. Known side effects to Montanide ISA-51\r\n\r\n 16. Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or\r\n hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis,\r\n autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis\r\n etc.\r\n\r\n 17. Severe allergy or anaphylactic reactions earlier in life\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ARG1-18,19,20\n- **Description:** 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03721549
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEvaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model\n\n**Trial Summary:** \n\n\n There is a need for safe, highly infectious Norovirus inocula for use in Norovirus\r\n vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune\r\n response among vaccinated and unvaccinated subjects. The purpose of this study is to generate\r\n the infection and illness rate and immune response data necessary for the conduct of future\r\n investigation of Norovirus vaccine studies.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Norovirus Infection\n\n**Condition Keywords:** Caliciviridae Infections\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 49 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - General good health, without significant medical illness, based on medical history,\r\n physical examination, vital signs, and clinical laboratories (CBC, chemistry, and\r\n urinalysis) as determined by the investigator in consultation with the research\r\n monitor and sponsor\r\n\r\n - Available for all planned visits and to spend at least 5 days in confinement\r\n\r\n - Confirmed blood type (A or O)\r\n\r\n - Demonstrated to be H type-1 antigen secretor positive (by saliva test)\r\n\r\n - Body mass index between 17 and 30 at screening\r\n\r\n - Female subjects must have a negative pregnancy test and either use contraceptives or\r\n be sterile\r\n\r\n - Available to return for follow-up visits following discharge from the inpatient unit\r\n and deliver stool specimens to the investigator promptly\r\n\r\n Exclusion Criteria:\r\n\r\n - Presence of significant medical condition\r\n\r\n - Donation or use of blood or blood products within 4 weeks prior to challenge\r\n\r\n - Diagnosed bleeding disorder or significant bruising or bleeding difficulties that\r\n could make blood draws problematic\r\n\r\n - Abnormal stool pattern\r\n\r\n - Any gastroenteritis within the past 2 weeks\r\n\r\n - Occupational hazards, including having daily contact with children under the age of 5,\r\n women known to be pregnant, employment in the food service industry, health care\r\n workers, etc.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Norwalk GI.1 Virus\n- **Description:** Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03633448
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nStudy to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents\n\n**Trial Summary:** \n\n\n Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an\r\n immediate-release formulation when a single dose is administered in adolescents and in adults\r\n when compared to Children.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy Subjects\n\n**Condition Keywords:** None\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 12 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Males and females ≥ 12 and < 18 years of age or ≥ 18 and < 55 years of age.\r\n\r\n All females who were of childbearing potential had to be using one of the following\r\n acceptable birth control methods for the time periods specified:\r\n\r\n 1. Intrauterine device (IUD) in place for at least 3 months prior to Day 1 of Period\r\n 1 through 30 days beyond study completion (Day 1 of Period 2).\r\n\r\n 2. Barrier method (condom or diaphragm) with spermicide for at least 7 days prior to\r\n screening through 30 days beyond study completion (Day 1 of Period 2)\r\n\r\n 3. Stable hormonal contraceptive (oral, depo injection, transdermal patch, or\r\n vaginal ring) for at least 3 months prior to Day 1 of Period 1 through 30 days\r\n beyond completion of study (Day 1 of Period 2).\r\n\r\n Note: Abstinence (sexually inactive) was not an acceptable form of contraception;\r\n however, abstinent female subjects could have been admitted to the study if they\r\n agreed, and had signed a statement to the effect, that upon becoming sexually active,\r\n would use a condom with spermicide from that time through 30 days beyond completion of\r\n the study (Day 1 of Period 2).\r\n\r\n Females ≥ 18 years of age of non-childbearing potential must have been surgically\r\n sterile (bilateral tubal ligation with surgery at least 6 months prior to Day 1 of\r\n Period 1 or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day\r\n 1 of Period 1) or post-menopausal ≥ 2 years prior to Day 1 of Period 1. A follicle\r\n stimulating hormone (FSH) level > 40 miU/mL must have been obtained and in the record\r\n for any post-menopausal female experiencing their last menses < 2 years prior to Day 1\r\n of Period 1.\r\n\r\n 2. Negative urine pregnancy test at Screening and each Check-in for all female subjects.\r\n\r\n 3. Good general health as determined by the PI's review of medical history, physical\r\n examination, vital sign measurements (after 2 minutes resting in the seated position),\r\n and clinical laboratory measures.\r\n\r\n 4. For subjects ≥ 18 and < 55 years of age, body mass index (BMI) of 19 to 29 kg/m2,\r\n inclusive. (BMI = weight (kg)/[height (m)]2).\r\n\r\n 5. Subjects ≥ 12 and < 18 years of age had to be > 5th percentile and less than the 95th\r\n percentile for weight and BMI of ≥ 18 to ≤ 28 kg/m2 based on age and gender.\r\n\r\n 6. Non-tobacco users, who had not used nicotine or nicotine-containing products for at\r\n least 1 year prior to Day 1 of Period 1.\r\n\r\n 7. Negative finding on tests for hepatitis B surface antigen (HBsAG), hepatitis C virus\r\n (HCV) antibodies, human immunodeficiency virus (HIV).\r\n\r\n 8. Negative urine screen for drugs of abuse and alcohol at Screening and each Check-in.\r\n\r\n 9. Likely to be compliant and complete the study, and if < 18 years of age had parent(s)\r\n or legally authorized representative(s) likely to be compliant with study\r\n requirements, according to the PI.\r\n\r\n 10. Able to read, understand, and sign the informed consent, after the nature of the study\r\n had been explained, and had read, signed, and dated an IRB-approved informed\r\n consent/assent form for subjects to participate in the study. Additionally, for\r\n subjects < 18 years of age, a parent(s) or legally authorized representative(s), had\r\n to read, sign, and date an IRB-approved informed consent/assent form for subjects < 18\r\n years of age to participate in the study.\r\n\r\n 11. Subjects < 18 years of age must have met the following at-risk requirements:\r\n\r\n 1. Frequency - a history of frequent upper respiratory infections (URIs) defined as\r\n > 4 infections per year for adolescents aged ≥ 12 to < 18 yrs, AND;\r\n\r\n 2. Exposure - Another family member in the home who was ill with URI/common cold or\r\n a child in the family who was attending preschool or school with ≥ 6 children in\r\n the group, AND;\r\n\r\n 3. Crowding - Greater than (>) 4 persons living in the home or > 3 persons sleeping\r\n in one bedroom.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Clinically significant abnormalities detected by medical history, physical\r\n examination, vital sign measurements, ECG findings, or clinical laboratory findings\r\n (as determined by the PI), including a hemoglobin value < 12 gm/dL at Screening.\r\n\r\n 2. Females who were pregnant or nursing.\r\n\r\n 3. History of hypersensitivity reaction to guaifenesin or to EMLA® cream (eutectic\r\n mixture of local anesthetic) or its components (lidocaine + prilocaine as local\r\n anesthetic).\r\n\r\n 4. Receipt of an investigational drug within 30 days prior to Day 1 of Period 1.\r\n\r\n 5. Abnormal diet (for whatever reason) during the 30 days prior to Day 1 of Period 1.\r\n\r\n 6. Donation of blood or significant loss of blood within 56 days prior to Day 1 of Period\r\n 1.\r\n\r\n 7. Donation of plasma within 14 days prior to Day 1 of Period 1.\r\n\r\n 8. Known or suspected use of illicit drugs (i.e., opiates, barbiturates, marijuana, et.\r\n al.).\r\n\r\n 9. The use of any medication on a chronic basis, with the exception of hormonal\r\n contraceptives for women of child-bearing potential. An appropriate drug free period\r\n for prescription or OTC drugs should have been provided to wash out any especially\r\n long half-life drugs.\r\n\r\n 10. Alcoholism or medicinal product or drug abuse within the past two years or excessive\r\n alcohol consumption (more than 10 units per week) (one unit was defined as 5 ounces of\r\n wine, 12 ounces of beer, or 1.5 ounces of spirits (i.e., \"hard\" liquor such as gin,\r\n whiskey, or vodka, et. al.). The subject was not to experience tolerance, withdrawal,\r\n compulsive use, or substance related problems such as medical complications,\r\n disruption in social and family relationships, vocational or financial difficulties,\r\n or legal problems.\r\n\r\n 11. Consumption of grapefruit, pummelo, Seville orange or grapefruit juice within 14 days\r\n prior to dosing with study medication. Subjects had to be willing to abstain from\r\n consuming any of these products during the study.\r\n\r\n 12. Related to persons involved directly or indirectly with the conduct of this study\r\n (i.e., PI, Sub-Investigators, Study Coordinators, other study personnel, employees of\r\n Reckitt Benckiser, and the families of each).\r\n\r\n Subject Exclusion Criteria at Check-In\r\n\r\n 1. Any significant change from Screening in medical history, medication history, alcohol\r\n consumption, or tobacco/nicotine use, in the opinion of the PI.\r\n\r\n 2. Reports any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to\r\n enzyme-inducers such as paint solvents or pesticides since Screening, unless approved\r\n by Reckitt Benckiser.\r\n\r\n 3. Reports any other prescription or OTC drug or herbal remedy since Screening (except\r\n for low-dose contraceptives, multivitamins, and/or fluoride supplements) unless\r\n allowed by Reckitt Benckiser.\r\n\r\n 4. If female, a positive urine pregnancy test.\r\n\r\n 5. Had an acute illness since Screening, unless allowed by Reckitt Benckiser.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** [\"Children's Mucinex® Grape Flavor\", \"Children's Mucinex® Grape Flavor\"]\n- **Description:** [\"1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation\", \"1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation\"]\n- **Mesh Terms:** ['Phenylpropanolamine', 'Guaifenesin', 'Chlorpheniramine, phenylpropanolamine drug combination']\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02814656
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD8871 in Healthy Subjects\n\n**Trial Summary:** \n\n\n AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which\r\n presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and\r\n potentially also asthma (in combination with an inhaled corticosteroid [ICS]). The\r\n therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism\r\n bronchodilators, with an equivalent or superior safety and tolerability profile. The primary\r\n purpose of this study is to check the safety and tolerability of AZD8871 at steady state. A\r\n multiple ascending dose (MAD) design has been selected for this study following the first\r\n time in man (FTIM), single ascending dose (SAD) study. Three dose levels will be tested in an\r\n ascending manner. The first dose to be administered will be 300 μg and the 2 subsequent doses\r\n will be decided based on safety, tolerability and pharmacokinetic (PK) data generated in the\r\n previous dose. The aim of this study is to also enable further investigations in healthy\r\n subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an acceptable\r\n side-effect profile compared to other inhaled bronchodilators on the market as a treatment\r\n for COPD and asthma.\r\n \n\n**Trial Keywords:** ['muscarinic receptor antagonist and β2 adrenoceptor agonist [MABA]', 'chronic obstructive pulmonary disease', 'Asthma (in combination with an inhaled corticosteroid [ICS]', 'alpha-lactose monohydrate', 'dry powder inhaler', 'long-acting β2-agonist (LABA)', 'long-acting muscarinic antagonist (LAMA)', 'fixed-dose combination (FDC)']\n\n**Phase:** Phase 1\n\n**Condition:** Chronic Obstructive Pulmonary Disease\n\n**Condition Keywords:** ['Lung Diseases', 'Lung Diseases, Obstructive', 'Pulmonary Disease, Chronic Obstructive']\n\n**ICD Code:** [\"['J44.9', 'J44.89', 'J44.1', 'J44.0']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Provision of written informed consent prior to conducting any study-related\r\n procedures, including withdrawal of medications.\r\n\r\n 2. Male subjects aged 18 to 55 years, inclusive at Screening.\r\n\r\n 3. Body mass index (BMI) calculated as weight in kg/height in m2 from ≥18 to ≤30 kg/m2\r\n and weight ≥50 kg at Screening.\r\n\r\n 4. Healthy, free from any clinically significant disease/ conditions (including all\r\n cardiovascular conditions), as determined by medical history, physical examination,\r\n clinical laboratory testing, 12-lead ECG findings at Screening and admission to the\r\n unit.\r\n\r\n 5. Spirometry readings (FEV1 and Forced Vital Capacity [FVC]) to be ≥80% of predicted\r\n value calculated using Quanjer 2012 reference equations (Quanjer et al 2012) at\r\n Screening.\r\n\r\n 6. Normal blood pressure (BP) (defined as systolic BP [SBP] ≥90 and ≤140 mmHg, and\r\n diastolic BP [DBP] ≥50 and ≤90 mmHg) at Screening and admission to the unit, measured\r\n after resting in supine position for at least 10 minutes.\r\n\r\n 7. Normal heart rate (HR) (defined as HR ≥45 and ≤90) measured after resting in supine\r\n position for at least 10 minutes at Screening and admission to the unit.\r\n\r\n 8. Negative for hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody\r\n (IgM), hepatitis C antibody and human immunodeficiency virus (HIV) I and II antibodies\r\n at Screening.\r\n\r\n 9. Negative for drugs of abuse and alcohol tests at Screening and admission to the unit.\r\n\r\n 10. Normal serum potassium at Screening and at admission to the unit.\r\n\r\n 11. Willing and able to comply with study specific procedures and restrictions\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca\r\n staff and/or staff at the study site).\r\n\r\n 2. Surgical history clinically relevant for the purpose of the study or any clinically\r\n significant illness, medical/surgical procedure or trauma within 4 weeks of Screening.\r\n\r\n 3. History of malignancy of any organ system, treated or untreated within the past 5\r\n years, with the exception of localised basal cell carcinoma of the skin.\r\n\r\n 4. Current smokers, or a smoking history during the last 6 months or total smoking\r\n history of more than 10 pack-years. Use of electronic cigarettes or other forms of\r\n nicotine, current use or use within the last 6 months.\r\n\r\n 5. Prolonged QTcF interval, >450 ms at Screening, or family history of long QT syndrome.\r\n\r\n 6. Any clinically significant arrhythmia noted on telemetry recording, prior to\r\n randomisation.\r\n\r\n 7. History of excessive use or abuse of alcohol within the past 2 years.\r\n\r\n 8. History of drug abuse within the past 2 years.\r\n\r\n 9. Donation or loss >400 ml of blood and plasma within the previous 3 months prior to\r\n Visit 1, Screening.\r\n\r\n 10. History of presence of severe allergy/hypersensitivity or ongoing\r\n allergy/hypersensitivity to any drug, as judged by the Investigator or history of\r\n hypersensitivity to drugs pharmacologically related to study drug.\r\n\r\n 11. PR (PQ) interval shortening <120 ms (PR >110 ms but <120 ms is acceptable if there is\r\n no evidence of ventricular pre-excitation) at Screening.\r\n\r\n 12. PR (PQ) interval prolongation (> 240 ms), intermittent second (Wenckebach block while\r\n asleep is not exclusive), or third degree atrioventricular block, or atrioventricular\r\n dissociation at Screening.\r\n\r\n 13. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle\r\n branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS >110 ms.\r\n\r\n 14. Subject who does not agree to follow instructions to avoid partner pregnancy.\r\n\r\n 15. Subject who is not able to adhere to the restrictions on prior and concomitant\r\n medications.\r\n\r\n 16. Used any investigational drug within 3 months prior to Screening or within the\r\n equivalent time of 5 half-lives of receiving the last administration, whichever is\r\n longer, or on an extended follow-up after receiving an IMP.\r\n\r\n 17. Subjects unable to communicate reliably with the Investigator.\r\n\r\n 18. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship,\r\n trusteeship, or committed to an institution by governmental or juridical order.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['AZD8871', 'Placebo']\n- **Description:** ['Multiple inhaled doses of AZD8871 will be administered via single dose dry powder inhaler (DPI). Each subject will receive a single inhaled dose of AZD8871 on Day 1 and then single once daily inhalations of AZD8871 will be administered for 12 days from Day 5 until Day 16.', 'Multiple inhaled doses of placebo powder will be administered via single dose DPI. Each subject will receive a single inhaled dose of placebo on Day 1 and then single once daily inhalations of placebo will be administered for 12 days from Day 5 until Day 16.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03733210
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nPanitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer\n\n**Trial Summary:** \n\n\n This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying\r\n cancer that has spread to the lymph nodes in patients with squamous cell head and neck\r\n cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during\r\n surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount\r\n of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans\r\n make detailed, computerized pictures of areas inside the body where the drug is used. Giving\r\n panitumumab-IRDye800 and 89Zr-panitumumab to patients with head and neck cancer may help\r\n doctors find metastatic lymph nodes better than current methods [positron emission tomography\r\n (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations].\r\n \n\n**Trial Keywords:** Head and Neck Cancer\n\n**Phase:** Phase 1\n\n**Condition:** ['Squamous Cell Carcinoma of the Head and Neck', 'Carcinoma of the Head and Neck']\n\n**Condition Keywords:** ['Carcinoma', 'Head and Neck Neoplasms', 'Squamous Cell Carcinoma of Head and Neck']\n\n**ICD Code:** [\"['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 19 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.\r\n\r\n - Subjects diagnosed with any T stage, any subsite within the head and neck that are\r\n scheduled to undergo surgical resection. Subjects with recurrent disease or a new\r\n primary will be allowed.\r\n\r\n - Planned standard of care surgery with curative intent for squamous cell carcinoma.\r\n\r\n - Hemoglobin ≥ 9 gm/dL.\r\n\r\n - White blood cell count > 3000/mm³.\r\n\r\n - Platelet count ≥ 100,000/mm³.\r\n\r\n - Serum creatinine ≤ 1.5 times upper reference range.\r\n\r\n Exclusion Criteria:\r\n\r\n - Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive\r\n heart failure (CHF); significant liver disease; or unstable angina within 6 months\r\n prior to enrollment.\r\n\r\n - Previous bilateral neck dissection.\r\n\r\n - History of infusion reactions to monoclonal antibody therapies.\r\n\r\n - Pregnant or breastfeeding.\r\n\r\n - Magnesium or potassium lower than the normal institutional values.\r\n\r\n - Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide,\r\n amiodarone, sotalol) antiarrhythmic agents.\r\n\r\n - Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\r\n\r\n - Severe renal disease or anuria.\r\n\r\n - Known hypersensitivity to deferoxamine or any of its components.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Panitumumab-IRDye800', '89-Zirconium (Zr-89) Panitumumab', 'Pinpoint IR IR9000 fluorescence imaging system (FIS)', 'SPY-PHI IR9000 fluorescence imaging system (FIS)', 'Explorer Air camera', 'PDE-NEO II camera', 'FIS-00 fluorescence imaging system (FIS)', 'Da Vinci Firefly Imaging System', 'IGP-ELVIS-v4 Macroscopic Specimen Imager', 'Vevo 3100 LAZR-X', 'Pearl Triology Imaging System', 'Odyssey CLx Imaging System', 'Leica fluorescence microscope']\n- **Description:** ['30 mg administered intravenously (IV)', '0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)', 'Handheld fluorescence-imaging endoscope manufactured by Novadaq', 'Handheld fluorescence-imaging endoscope manufactured by Novadaq', 'Fluorescence camera manufactured by SurgVision', 'Medical infrared camera manufactured by Hamamatsu Photonics KK', 'Fluorescence-imaging system (FIS) manufactured by Hamamatsu Photonics KK', 'Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc', 'Macroscopic specimen imager manufactured by LI-COR Biosciences', 'Photoacoustic ultrasound imaging system manufactured by VisualSonics', 'Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences', 'Infrared fluorescent-imaging system manufactured by LI-COR Biosciences', 'Fluorescence microscope manufactured by Leica']\n- **Mesh Terms:** Panitumumab\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03624946
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nStudy in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG)\n\n**Trial Summary:** \n\n\n Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet\r\n medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic\r\n intervention against Zika virus infection. In this first-in-human study, evaluation of\r\n ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted\r\n in healthy adult volunteers.\r\n \n\n**Trial Keywords:** ['Zika virus', 'Human immune globulin', 'Hyperimmune', 'Polyclonal antibodies']\n\n**Phase:** Phase 1\n\n**Condition:** ['Zika Virus Infection', 'Zika Virus Disease']\n\n**Condition Keywords:** ['Virus Diseases', 'Zika Virus Infection']\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Informed consent voluntarily signed by subject.\r\n\r\n 2. Age: 18-55 years of age.\r\n\r\n 3. Blood type O+ or O-.\r\n\r\n 4. Body mass index (BMI) of 18-30.\r\n\r\n - Note: minimum body weight of 50 kg.\r\n\r\n 5. For female subjects (with male partners) that are not surgically sterilized (e.g., did\r\n not undergo hysterectomy, bilateral oophorectomy or tubal ligation), use of an\r\n effective method of contraception throughout the trial including:\r\n\r\n - Using hormonal contraception (oral, injectable or implant) continuously for 3\r\n months prior to screening and willing to continue to use hormonal contraception\r\n throughout the entire trial.\r\n\r\n - Intrauterine device (IUD) inserted at least 1 month prior to screening.\r\n\r\n - Double barrier type of birth control measure (e.g., condoms, diaphragms, cervical\r\n sponge with spermicide).\r\n\r\n - True abstinence.\r\n\r\n - For female subjects who are post-menopausal, documented follicle- stimulating\r\n hormone (FSH) ≥40 milli-international units per milliliter (mIU/mL) must be\r\n obtained. If the FSH is <40 mIU/mL, the subject must agree to use an acceptable\r\n form of contraception (see above).\r\n\r\n - Females of childbearing potential without male sexual partners must be willing to\r\n maintain their sexual status as it is throughout the study.\r\n\r\n 6. For male subjects that have not had a vasectomy, use of a condom with spermicide or\r\n true abstinence for the duration of the study. Note: female partners (that are of\r\n childbearing potential) of male study subjects (that have not had a vasectomy) should\r\n use one of the effective contraception methods (eg, hormonal contraception, IUD or\r\n barrier type). Also, male subjects must not donate sperm for the duration of the\r\n study.\r\n\r\n - Males without female sexual partners must be willing to maintain their sexual\r\n status as it is throughout the study.\r\n\r\n 7. Healthy as determined by principal investigator or a qualified designate based on\r\n medical history, physical exam, vital signs, urinalysis, blood chemistry and\r\n hematology test results at screening.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Use of any investigational product within the past 30 days.\r\n\r\n 2. Use of any investigational product during the study.\r\n\r\n 3. Individuals with blood type A, B or AB.\r\n\r\n 4. Recipient of any blood product within the past 12 months.\r\n\r\n 5. Plasma donation within 7 days or significant blood loss or blood donation within 56\r\n days of baseline.\r\n\r\n 6. Blood donation at any time during the study.\r\n\r\n 7. Females with a hemoglobin level ≤120 g/L.\r\n\r\n 8. Males with a hemoglobin level <130 g/L.\r\n\r\n 9. History of hypersensitivity to blood or plasma products.\r\n\r\n 10. History of allergy to latex or rubber.\r\n\r\n 11. History of immunoglobulin A (IgA) deficiency.\r\n\r\n 12. History of hypercoagulable conditions (e.g., deep vein thrombosis or pulmonary\r\n embolism).\r\n\r\n 13. History of myocardial infarction.\r\n\r\n 14. History of stroke.\r\n\r\n 15. History of renal impairment/failure.\r\n\r\n 16. Currently pregnant or lactating or planning to become pregnant during the study.\r\n\r\n 17. History of flavivirus infection [ZIKV, dengue virus (DENV), West Nile virus (WNV),\r\n Japanese encephalitis virus (JEV), yellow fever virus (YFV)] or vaccination with\r\n licensed or investigational flavivirus vaccine.\r\n\r\n 18. Plans to travel to an area with active flavivirus (e.g., ZIKV and/or DENV)\r\n transmission during the study (and up to 10 months after the study drug\r\n administration) or has returned from an endemic area with these diseases within 30\r\n days of screening.\r\n\r\n 19. Positive nucleic acid test (NAT) or serology for ZIKV or positive serology for WNV or\r\n DENV.\r\n\r\n 20. Positive serology test (at screening) for human immunodeficiency virus 1 and 2 (HIV),\r\n hepatitis C virus (HCV); positive test for hepatitis B virus (HBV) as determined by\r\n HBsAg.\r\n\r\n 21. History of chronic or acute severe neurologic condition (e.g., diagnosis of\r\n Guillain-Barre syndrome, epilepsy, Bell's palsy, meningitis or disease with any focal\r\n neurologic deficits).\r\n\r\n 22. Heavy smokers (≥15cigarettes a day) or electronic cigarette use.\r\n\r\n 23. History of, or suspected substance abuse problem (including alcohol).\r\n\r\n 24. Failure of drug (urine) test at screening or baseline.\r\n\r\n 25. Failure of alcohol (breath) test at screening or baseline.\r\n\r\n 26. Receipt of a live vaccine within 28 days prior to screening or anticipated receipt of\r\n a live vaccine during the study period.\r\n\r\n 27. Individuals with planned surgical procedures that will occur during the study.\r\n\r\n 28. An opinion of the investigator that it would be unwise to allow participation of the\r\n subject in the study.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Zika Virus Immune Globulin (ZIKV-IG)', 'Placebo']\n- **Description:** ['Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.', 'Placebo is a normal saline solution (0.9% sodium chloride).']\n- **Mesh Terms:** ['Immunoglobulins', 'Antibodies', 'gamma-Globulins', 'Immunoglobulins, Intravenous', 'Rho(D) Immune Globulin', 'Immunoglobulin G']\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03382509
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nThis Study Tests BI 1467335 in Healthy Male Volunteers. The Study Tests How Different Doses of BI 1467335 Are Taken up and Handled by the Body\n\n**Trial Summary:** \n\n\n Primary objective mass balance, excretion pathways and metabolism following a single oral\r\n dose of [14C]BI 1467335 given to healthy male subjects (a selected number of subjects will be\r\n treated with [14C]BI 1467335 after a preceding 27 days treatment with non-radiolabelled\r\n compound of BI 1467335 QD).\r\n\r\n Secondary objectives is to investigate the basic pharmacokinetics after single and multiple\r\n doses of BI 1467335 and its metabolites.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 30 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Healthy male subjects according to the investigator's assessment, based on a complete\r\n medical history including a physical examination, vital signs (Blood pressure (BP),\r\n Pulse rate (PR)), 12-lead Electrocardiogram, and clinical laboratory tests\r\n\r\n - Age of 30 to 65 years (incl.)\r\n\r\n - Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)\r\n\r\n - Signed and dated written informed consent prior to admission to the study in\r\n accordance with Good Clinical Practice (GCP) and local legislation\r\n\r\n - Subjects who are sexually active must use, with their partner, highly effective\r\n contraception from the time of administration of trial medication until 4 months after\r\n administration of trial medication. --Adequate methods are:\r\n\r\n - Condoms plus use of hormonal contraception by the female partner that started at\r\n least 2 months prior to administration of trial medication (e.g., implants,\r\n injectables, combined oral or vaginal contraceptives, intrauterine device) or\r\n\r\n - Condoms plus surgical sterilization (vasectomy at least 1 year prior to\r\n enrolment) or\r\n\r\n - Condoms plus surgically sterilised partner (including hysterectomy) or\r\n\r\n - Condoms plus intrauterine device or\r\n\r\n - Condoms plus partner of non-childbearing potential (including homosexual men)\r\n\r\n - Subjects are required to use condoms to prevent unintended exposure of the\r\n partner to the study drug via seminal fluid.\r\n\r\n - Alternatively, true abstinence is acceptable when it is in line with the\r\n subject's preferred and usual lifestyle. If a subject is usually not\r\n sexually active but becomes active, with their partner, they must comply\r\n with the contraceptive requirements detailed above\r\n\r\n Exclusion Criteria:\r\n\r\n - Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR)\r\n or Electrocardiogram) is deviating from normal and judged as clinically relevant by\r\n the investigator\r\n\r\n - Any laboratory value outside the reference range that the investigator considers to be\r\n of clinical relevance\r\n\r\n - Any evidence of a concomitant disease judged as clinically relevant by the\r\n investigator\r\n\r\n - Clinically significant gastrointestinal, hepatic, renal, respiratory (including but\r\n not limited to interstitial lung disease), cardiovascular, metabolic, immunological or\r\n hormonal disorders\r\n\r\n - Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with\r\n the pharmacokinetics of the trial medication (except appendectomy and simple hernia\r\n repair)\r\n\r\n - Diseases of the central nervous system (including but not limited to any kind of\r\n seizures or stroke), and other relevant neurological or psychiatric disorders\r\n\r\n - History of relevant orthostatic hypotension, fainting spells, or blackouts\r\n\r\n - Chronic or relevant acute infections\r\n\r\n - History of relevant allergy or hypersensitivity (including allergy to the trial\r\n medication or its excipients)\r\n\r\n - Within 30 days prior to administration of trial medication, use of drugs that might\r\n reasonably influence the results of the trial or that might prolong the QT/QTc\r\n interval\r\n\r\n - Participation in another trial where an investigational drug has been administered\r\n within 60 days prior to planned administration of trial medication, or current\r\n participation in another trial involving administration of investigational drug\r\n\r\n - Smoker (more than 5 cigarettes or 1 cigar or 1 pipe per day)\r\n\r\n - Inability to refrain from smoking on specified trial days\r\n\r\n - Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals\r\n approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)\r\n\r\n - Drug abuse or positive drug screening\r\n\r\n - Blood donation of more than 100 mL within 30 days prior to administration of trial\r\n medication or intended donation during the trial\r\n\r\n - Inability to comply with dietary regimen of trial site\r\n\r\n - A marked baseline prolongation of QT/QTc interval (such as QTcF intervals that are\r\n repeatedly greater than 450 ms) or any other relevant Electrocardiogram finding at\r\n screening\r\n\r\n - A history of additional risk factors for Torsades de Pointes (such as heart failure,\r\n hypokalemia, or family history of Long QT Syndrome)\r\n\r\n - Subject is assessed as unsuitable for inclusion by the investigator, for instance,\r\n because considered not able to understand and comply with study requirements, or has a\r\n condition that would not allow safe participation in the study\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['[14C]BI 1467335', 'BI 1467335']\n- **Description:** ['Once Daily', 'Twice Daily']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04035473
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel\n\n**Trial Summary:** \n\n\n This is a multicenter, open-label, 2-stage study with a 2-treatment period crossover design.\r\n Eligible participants are adults with cancer for whom weekly therapy with IV paclitaxel at a\r\n dose of 80 mg/m2 over 1 hour is indicated.\r\n\r\n Stage 1 will consist of an initial cohort (Cohort 1) up to 6 evaluable participants who will\r\n receive a dosing regimen of Oraxol consisting of a 15-mg oral HM30181AK-US tablet plus an\r\n oral paclitaxel dose of 205 mg/m2, both administered once daily for 3 consecutive days. The\r\n stages and cohorts are further described in the \"Study Design - Stages and Cohorts\" table\r\n below. An interim analysis of pharmacokinetic (PK) data from Cohort 1 will be conducted to\r\n determine if the administered regimen would appear likely to achieve bioequivalence(BE)\r\n (AUC0-∞), if tested in a greater number of participants in Stage 2. If it appears unlikely\r\n that the selected regimen will meet the criteria for BE based on AUC0-∞ data, a second cohort\r\n (Cohort 2) of up to 6 evaluable participants may be enrolled in Stage 1, and the dose of\r\n paclitaxel in Oraxol may be adjusted by a maximum of +/- 25%. If Cohort 2 is enrolled, a\r\n second interim analysis will be conducted.\r\n\r\n After the interim analysis/analyses (depending on the outcomes), a decision will be made by\r\n consensus of the Data Safety and Monitoring Board(DSMB), Kinex, Zenith Technology, and the\r\n Principal Investigator as to what dose should be administered in Stage 2. The DSMB will\r\n consist of a clinical oncologist, an ethicist, an independent statistician, and additional\r\n members, as deemed necessary. A DSMB charter will describe the planned evaluations and\r\n decision points used to determine the dose for Stage 2. An additional 18 to 42 evaluable\r\n participants will be enrolled into Stage 2 based on the Stage 1 results (AUC0-∞). Thus a\r\n total of up to 54 evaluable participants could potentially be enrolled in this study (6 each\r\n from Stage 1, Cohorts 1 and 2, and up to 42 participants in Stage 2).\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Solid Tumor\n\n**Condition Keywords:** None\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Signed written informed consent\r\n\r\n 2. Males and females ≥18 years of age on day of consent\r\n\r\n 3. Cancer patients for whom treatment with IV paclitaxel at 80 mg/m2has been recommended\r\n by their oncologist, either as monotherapy or in combination with other agents\r\n\r\n 4. Adequate hematologic status at Screening/Baseline:\r\n\r\n - Absolute neutrophil count (ANC) ≥1.5 x 109/L\r\n\r\n - Platelet count ≥100 x 109/L\r\n\r\n - Hemoglobin (Hgb) ≥90 g/L\r\n\r\n 5. Adequate liver function at Screening/Baseline as demonstrated by:\r\n\r\n - Total bilirubin of ≤20 μmol/L or ≤30 μmol/L for participants with liver\r\n metastasis\r\n\r\n - Alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN) or ≤5 x ULN if\r\n liver metastasis is present\r\n\r\n - Alkaline phosphatase (ALP) ≤3 x ULN or ≤5 x ULN if liver or bone metastasis are\r\n present\r\n\r\n - ALP >5 x ULN if liver or bone metastasis are present and the major fraction of\r\n ALP is from bone metastasis, at the discretion of the Investigator\r\n\r\n - Gamma glutamyl transferase (GGT) <10 x ULN\r\n\r\n 6. Adequate renal function at Screening/Baseline as demonstrated by serum creatinine ≤177\r\n μmol/L or creatinine clearance >50 mL/min as calculated by the Cockcroft and Gault\r\n formula\r\n\r\n 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 16\r\n\r\n 8. Life expectancy of at least 3 months\r\n\r\n 9. Willing to fast for 8 hours before and 4 hours after Oraxol administration\r\n\r\n 10. Willing to abstain from alcohol consumption for 3 days before the first dose of study\r\n drug through the completion of protocol-specified PK sampling in Treatment Period 2\r\n\r\n 11. Willing to refrain from caffeine consumption for 12 hours before each treatment period\r\n through the completion of protocol-specified PK sampling for that dose\r\n\r\n 12. Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by\r\n hysterectomy and/or bilateral oophorectomy) or, if sexually active, must be using\r\n effective contraception (ie, oral contraceptives, intrauterine device, double barrier\r\n method of condom and spermicide) and agree to continue use of contraception for the\r\n duration of their participation in the study. Women of childbearing potential must\r\n agree to use contraception for 30 days after their last dose of study drug.\r\n\r\n 13. Sexually active male participants must use a barrier method of contraception during\r\n the study and agree to continue the use of male contraception for at least 30 days\r\n after the last dose of study drug.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Currently taking a prohibited concomitant medication:\r\n\r\n - Strong inhibitors (eg, ketoconazole) or strong inducers (eg, rifampin or St.\r\n John's Wort) of cytochrome P450 (CYP) 3A4 (within 2 weeks prior to the start of\r\n dosing in the study)\r\n\r\n - Strong inhibitors (eg, gemfibrozil) or strong inducers (eg, rifampin) of CYP2C8\r\n (within 2 weeks prior to the start of dosing in the study)\r\n\r\n - Known P-glycoprotein (P-gp) inhibitors or inducers. Participants who are taking\r\n such medications but who are otherwise eligible may be enrolled if they\r\n discontinue the medication ≥1 week before dosing and remain off that medication\r\n through the end of PK sampling after the administration of the second study\r\n treatment.\r\n\r\n - An oral medication with a narrow therapeutic index known to be a P-gp substrate\r\n (eg, digoxin, dabigatran) within 24 hours prior to start of dosing in the study\r\n\r\n 2. Use of warfarin. Participants receiving warfarin who are otherwise eligible and who\r\n may be appropriately managed with low molecular weight heparin, in the opinion of the\r\n Investigator, may be enrolled in the study provided they are switched to low molecular\r\n weight heparin at least 7 days prior to receiving study treatment.\r\n\r\n 3. Unresolved toxicity from prior chemotherapy (participants must have recovered all\r\n significant toxicity to ≤ Grade 1 CTCAE toxicity1 from previous anticancer treatments\r\n or previous investigational agents). This does not extend to symptoms or findings that\r\n are attributable to the underlying disease\r\n\r\n 4. Received investigational agents within 14 days or 5 half-lives prior to the first\r\n study dosing day, whichever is longer\r\n\r\n 5. Women of childbearing potential who are pregnant or breastfeeding\r\n\r\n 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n infection, symptomatic congestive heart failure, clinically significant myocardial\r\n infarction within the last 6 months, unstable angina pectoris, clinically significant\r\n cardiac arrhythmia, bleeding disorder, chronic pulmonary disease requiring oxygen, or\r\n psychiatric illness/social situations that would limit compliance with study\r\n requirements\r\n\r\n 7. Major surgery to the upper GI tract, or have a history of GI disease or other medical\r\n condition that, in the opinion of the Investigator may interfere with oral drug\r\n absorption\r\n\r\n 8. A known history of allergy to paclitaxel. Participants whose allergy was due to the IV\r\n solvent (such as Cremophor®) and not paclitaxel will be eligible for this study.\r\n\r\n 9. Any other condition which the Investigator believes would make a subject's\r\n participation in the study not acceptable\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules\n- **Description:** HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules\r\nOral paclitaxel capsules\n- **Mesh Terms:** Paclitaxel\nSMILES: ['[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02761694
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nVevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)\n\n**Trial Summary:** \n\n\n The primary objectives of this study are: Part 1 - Vevorisertib as single agent: To assess\r\n the safety and tolerability of vevorisertib in participants with advanced solid tumors with\r\n v-Akt murine thymoma viral oncogene homolog (AKT) 1, 2, 3 genetic alterations, activating\r\n phosphatidylinositol-3-kinase (PI3K) mutations, phosphatase and tensin homolog deleted on\r\n chromosome ten (PTEN)-null, or other known actionable PTEN mutations; Part 2 - Vevorisertib\r\n in combination with other anti-cancer agents: To assess the safety and tolerability of\r\n vevorisertib in combination with paclitaxel or fulvestrant in participants with advanced,\r\n inoperable, metastatic and/or recurrent solid tumors with\r\n phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) / PTEN\r\n actionable mutations and/or AKT genetic alterations.\r\n \n\n**Trial Keywords:** ['AKT1', 'AKT2', 'AKT3', 'PI3K', 'solid tumors', 'cancer', 'ARQ 751', 'PTEN']\n\n**Phase:** Phase 1\n\n**Condition:** ['Cancer', 'Solid Tumors']\n\n**Condition Keywords:** Neoplasms\n\n**ICD Code:** [\"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\", 'None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria\r\n\r\n 1. Signed written informed consent granted prior to initiation of any study-specific\r\n procedures\r\n\r\n 2. 18 years of age and older\r\n\r\n 3. Histologically and/or cytologically documented diagnosis of a selected tumor type that\r\n is locally advanced, inoperable, metastatic or recurrent (including but not restricted\r\n to breast cancer, TNBC [triple negative]; HR-positive [HR+]/HER2-negative [HER2-] or\r\n endometrial cancer)\r\n\r\n 4. Documented AKT genetic alterations or known actionable PIK3CA/PTEN mutations by\r\n genetic testing\r\n\r\n • Participants with tumors with PTEN null/PTEN loss-of-function mutations are not\r\n eligible\r\n\r\n 5. For combination arms; participants should be eligible for paclitaxel or fulvestrant\r\n therapy as per Investigator assessment\r\n\r\n 6. Failure to respond to standard systemic therapy, or for whom standard or curative\r\n systemic therapy does not exist or is not tolerable\r\n\r\n - Participants in single agent arm (with AKT genetic alterations) and participants\r\n in dose escalation cohorts of combination therapy arms should have at least one\r\n line of standard systemic therapy\r\n\r\n - Participants in single agent arm (with PIK3CA/PTEN actionable mutations) and\r\n participants in the expansion cohorts of combination therapy arms should have no\r\n more than 3 prior systemic regimens for the advanced disease\r\n\r\n - Neoadjuvant and adjuvant chemotherapy are considered one regimen if they are a\r\n continuation of the same regimen with interval debulking surgery\r\n\r\n - If the participant is refractory or has disease progression within 6 months after\r\n completion of the adjuvant treatment, then the adjuvant treatment should be\r\n considered as the line of treatment rather than an adjuvant therapy.\r\n\r\n - Endocrine (hormonal) therapy does not count toward total lines of therapy\r\n\r\n - Maintenance therapy is considered part of the preceding regimen if one or more of\r\n the same drugs are continued\r\n\r\n 7. Has at least one measurable target lesion according to RECIST v. 1.1\r\n\r\n 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1\r\n\r\n 9. Adequate organ function as indicated by the following laboratory values. (All\r\n laboratory tests must be obtained within 14 days prior to the first dose of study\r\n treatment):\r\n\r\n 1. Hematological\r\n\r\n - Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L\r\n\r\n - Platelet count (Plt) ≥ 100 x 10⁹/L\r\n\r\n - Hemoglobin (Hb) ≥ 9 g/dL\r\n\r\n - International normalized ratio (INR) 0.8 to upper limit of normal (ULN) or ≤\r\n 3 for participants receiving anticoagulant therapy such as Coumadin or\r\n heparin\r\n\r\n 2. Renal\r\n\r\n - Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60\r\n mL/min/1.73 m2 for participants with serum creatinine levels > 1.5 x\r\n institutional ULN\r\n\r\n 3. Hepatic\r\n\r\n - Total bilirubin ≤ 1.5 x ULN\r\n\r\n - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x\r\n ULN or ≤ 5 x ULN for participants with known liver metastases\r\n\r\n 4. Metabolic\r\n\r\n - Glycated hemoglobin (HbA1c) ≤ 8% (≤ 64 mmol/mol)\r\n\r\n 10. If a participant is currently receiving bisphosphonates or any other drug for\r\n treatment of osteoporosis, treatment-induced bone loss and metastases to bone, the\r\n participant must have received the bisphosphonates for at least four weeks prior to\r\n the first dose of study treatment\r\n\r\n • Initiation of bisphosphonates or similar agents during the study may be allowed\r\n provided the participant completes the first cycle of treatment without any dose\r\n limiting toxicity (DLT) and the Investigator rules out tumor progression\r\n\r\n 11. Male or female participants of child-producing potential must agree to use adequate\r\n contraception, including double-barrier contraceptive measures, oral contraception, or\r\n avoidance of intercourse during the study and for 90 days after the last dose of study\r\n treatment\r\n\r\n 12. Women of childbearing potential must have a negative serum pregnancy test. \"Women of\r\n childbearing potential\" is defined as sexually mature women who have not undergone a\r\n hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive\r\n months prior to the first dose of study treatment\r\n\r\n Exclusion Criteria\r\n\r\n 1. Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted\r\n therapy, or investigational agents within five half-lives or four weeks, whichever is\r\n shorter, prior to administration of the first dose of study treatment\r\n\r\n - To be eligible for study treatment, toxicity from prior treatment(s) must recover\r\n to Grade ≤ 1, except for alopecia\r\n\r\n - Concurrent systemic high-dose corticosteroids (in dosing exceeding 10 mg QD of\r\n prednisone equivalent) when used intermittently in an antiemetic regimen, for\r\n central nervous system (CNS) metastases management, or as a part of the\r\n premedication regimen are allowed\r\n\r\n 2. Radiation therapy within four weeks, or palliative radiation therapy within two weeks,\r\n prior to administration of the first dose of study treatment\r\n\r\n - To be eligible for study treatment, radiation therapy-related toxicity must\r\n recover to Grade ≤ 1 prior to administration of the first dose of study treatment\r\n\r\n - Concurrent palliative radiotherapy for local pain-control or prevention of\r\n fracture (for known bone metastases) may be allowed provided the participant\r\n completes the first cycle of treatment, does not meet criteria of progressive\r\n disease, and treated lesions will not be included in the target/non-target lesion\r\n assessment\r\n\r\n 3. Major surgical procedure within four weeks prior to administration of the first dose\r\n of study treatment\r\n\r\n • To be eligible for the study treatment, all surgical wounds must be fully healed,\r\n and any surgery-related adverse events must recover to Grade ≤ 1.\r\n\r\n 4. Unable or unwilling to swallow the complete daily dose of vevorisertib\r\n\r\n 5. Previous treatment with\r\n\r\n - AKT inhibitors (e.g., ARQ 092, MK-2206, GSK2141795, AZD5363; prior treatment with\r\n PI3K or mammalian target of rapamycin (mTOR) inhibitor are allowed)\r\n\r\n - Prior taxane therapy for the advanced, metastatic disease (for participants\r\n considered for vevorisertib +paclitaxel combination arm only)\r\n\r\n 6. Known prior allergic reaction to or severe intolerance of paclitaxel or fulvestrant.\r\n Intolerance is defined as a serious adverse event (AE), a grade 3 or 4 AE per Common\r\n Terminology Criteria for Adverse Events (CTCAE) v.4.03, or permanent treatment\r\n discontinuation\r\n\r\n 7. History of Type 1 diabetes mellitus or Type 2 diabetes mellitus requiring regular\r\n medication (other than oral hypoglycemic agents) or fasting glucose ≥ 160 mg/dL at\r\n Screening visit\r\n\r\n 8. Significant gastrointestinal disorder(s) that could, in the opinion of the\r\n Investigator, interfere with the absorption, metabolism, or excretion of vevorisertib\r\n (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, extensive\r\n gastric resection)\r\n\r\n 9. Known untreated or active CNS metastases and/or carcinomatous meningitis\r\n\r\n • To be eligible for the study treatment, participants must have stable disease ≥ 1\r\n month, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan,\r\n and have CNS metastases well controlled by low-dose steroids, anti-epileptics, or\r\n other symptom-relieving medications\r\n\r\n 10. History of myocardial infarction (MI) or New York Heart Association (NYHA) Class II-IV\r\n congestive heart failure within 6 months of the administration of the first dose of\r\n study treatment (MI occurring > 6 months of the first dose of study treatment will be\r\n permitted); Grade 2 or worse conduction defect (e.g., right or left bundle branch\r\n block)\r\n\r\n 11. A heart rate corrected QT (QTc) interval ≥ 480 msec, using the Fridericia's formula\r\n QTcF\r\n\r\n 12. Left ventricular ejection fraction (LVEF) <50% as determined by Multiple Gated\r\n Acquisition (MUGA) scan or echocardiogram (ECHO) in participants who received prior\r\n treatment with anthracyclines\r\n\r\n 13. Concurrent severe and/or uncontrolled illness not related to cancer and/or social\r\n situation that would limit compliance with study requirements, including but not\r\n limited to:\r\n\r\n - Psychiatric illness, substance abuse\r\n\r\n - Ongoing or active known infection, including human immunodeficiency virus (HIV)\r\n infection, hepatitis B or C virus\r\n\r\n - Significant pulmonary dysfunction, including pneumonitis, interstitial lung\r\n disease (ILD), idiopathic pulmonary fibrosis, cystic fibrosis, severe chronic\r\n obstructive pulmonary disease (COPD)\r\n\r\n - Peripheral neuropathy grade ≥2 (vevorisertib+paclitaxel combination arm)\r\n\r\n - Bleeding diathesis, thrombocytopenia or coagulation disorders\r\n (vevorisertib+fulvestrant combination arm)\r\n\r\n - Thrombotic/coagulation disorders within 6 months prior to the first dose of study\r\n treatment unless stable on anticoagulation for > 3 months\r\n\r\n 14. Active or history of other malignancy other than the current cancer within 2 years of\r\n the first dose of study treatment, with the exception of carcinoma in-situ of the\r\n cervix, basal cell carcinoma, and superficial bladder tumors curatively treated\r\n\r\n 15. Blood transfusion or administration of growth factors within 5 days prior to a blood\r\n draw being used to confirm eligibility\r\n\r\n 16. Pregnant or breastfeeding\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Vevorisertib', 'Fulvestrant', 'Paclitaxel']\n- **Description:** ['Administered as an oral dose every day or every other day.', 'Administered as an intramuscular (IM) injection.', 'Administered as an intravenous (IV) infusion.']\n- **Mesh Terms:** ['Paclitaxel', 'Fulvestrant']\nSMILES: ['[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]', '[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02192541
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nGanetespib and Ziv-Aflibercept in Refractory Gastrointestinal Carcinomas, Non-Squamous Non-Small Cell Lung Carcinomas, Urothelial Carcinomas, and Sarcomas\n\n**Trial Summary:** \n\n\n Background:\r\n\r\n - Some people have cancers that don't respond to standard treatments. In these cases, doctors\r\n may try to use drugs to slow the growth of the cancer.\r\n\r\n Objectives:\r\n\r\n - To test the safety and efficacy of the drug combination of ganetespib and ziv-aflibercept.\r\n\r\n Eligibility:\r\n\r\n - Adults age 18 and over with advanced cancer of the colon, lung, urinary tract, and\r\n sarcomas.\r\n\r\n Design:\r\n\r\n - Participants will be screened with medical history, blood tests, and scans to measure\r\n their tumors.\r\n\r\n - Participants will have one or two eye exams, with dilating eye drops.\r\n\r\n - Participants will get the study drugs at the clinic as an infusion in a vein. Ganetespib\r\n will be given once a week on the same day for 3 weeks in a row, followed by a 1-week\r\n rest period. Ziv-aflibercept will be given once every other week. The drugs will be\r\n given in 28-day cycles.\r\n\r\n - Participants may have a small piece of their tumor collected once or twice. This is done\r\n using a small needle during computed tomography (CT), magnetic resonance imaging (MRI),\r\n or ultrasound scan.\r\n\r\n - Participants will have their blood pressure checked at each visit. They will check it at\r\n home every day of the study.\r\n\r\n - Participants may have one or more whole-body positron emission tomography (PET) scans\r\n with 89Zr-panitumumab. A small amount of a radioactive chemical will be injected through\r\n a tube in an arm. Participants will lie on a bed that slides in and out of the\r\n donut-shaped PET scanner. They will have small amounts of blood drawn.\r\n\r\n - Participants may stay in the study as long as they are tolerating the drugs and their\r\n tumor is not getting worse.\r\n \n\n**Trial Keywords:** ['Urothelial Carcinomas', 'Non-Squamous Non-Small Cell Lung Carcinomas', 'Refractory Gastrointestinal Carcinomas', 'Hsp90 Inhibitor', 'Sarcomas']\n\n**Phase:** Phase 1\n\n**Condition:** Neoplasms\n\n**Condition Keywords:** ['Carcinoma', 'Sarcoma', 'Carcinoma, Transitional Cell', 'Lung Neoplasms', 'Carcinoma, Non-Small-Cell Lung']\n\n**ICD Code:** [\"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 120 Years\n- **Criteria:** \n - INCLUSION CRITERIA:\r\n\r\n Patients must have histologically confirmed recurrent or metastatic gastrointestinal\r\n carcinomas, non-squamous non-small cell lung carcinomas, urothelial carcinomas, and\r\n sarcomas with disease progression after at least one line of standard therapy. Disease\r\n should have progressed following all treatments known to prolong survival, unless a given\r\n treatment is contraindicated.\r\n\r\n - Patients with colorectal carcinoma must have progressed through at least two lines of\r\n standard chemotherapy in the metastatic setting.\r\n\r\n - Patients with non-small cell lung cancer with known sensitizing epidermal growth\r\n factor receptor (EGFR) mutation and/or anaplastic lymphoma receptor tyrosine kinase\r\n (ALK) rearrangement should have received prior erlotinib and/or crizotinib,\r\n respectively.\r\n\r\n - Patients with urothelial carcinoma will have progressed on prior platinum-based\r\n therapy or for which platinum-based therapy is contraindicated.\r\n\r\n - Patients enrolled on the expansion phase of the protocol must demonstrate EGFR\r\n expression by immunohistochemistry on archival tumor samples prior to undergoing (89)\r\n Zr-panitumumab positron emission tomography (PET)/computed tomography (CT) scans.\r\n\r\n Age greater than or equal to 18 years of age.\r\n\r\n Eastern Cooperative Oncology Group (ECOG) performance status < 2.\r\n\r\n Life expectancy > 3 months.\r\n\r\n Patients must have normal organ and marrow function as defined below:\r\n\r\n - absolute neutrophil count greater than or equal to 1,500/mcL\r\n\r\n - platelets greater than or equal to 100,000/mcL\r\n\r\n - total bilirubin less than or equal to 1.5 times institutional upper limit of normal\r\n\r\n - Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase SGOT)/alanine\r\n aminotransferase (ALT)(serum glutamic pyruvic transaminase SGPT) less than or equal to\r\n 3 times institutional upper limit of normal\r\n\r\n - creatinine less than or equal to 1.2 times institutional upper limit of normal\r\n\r\n OR\r\n\r\n - creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for patients with\r\n creatinine levels above institutional normal\r\n\r\n - urine protein/creatinine < 1 mg/mg\r\n\r\n - International Normalized Ratio (INR) < 1.5\r\n\r\n Cardiac function within institutional normal limits on echocardiogram.\r\n\r\n Patients must have blood pressure no greater than 140 mmHg (systolic blood pressure) and 90\r\n mmHg (diastolic blood pressure) for eligibility. Initiation or adjustment of\r\n antihypertensive medications is permitted prior to study entry provided that the average of\r\n three blood pressure measurements at enrollment visit is less than 140/90 mmHg.\r\n\r\n The effects of ganetespib on the developing human fetus are unknown. For this reason and\r\n because anti-angiogenic agents similar to ziv-aflibercept are known to be teratogenic,\r\n women of child-bearing potential and men must agree to use two forms of contraception\r\n (hormonal or barrier method of birth control; abstinence; sterilization) prior to study\r\n entry, for the duration of study participation, and for 3 months after completing study\r\n treatment. Should a woman become pregnant or suspect she is pregnant while she or her\r\n partner is participating in this study, she should inform her treating physician\r\n immediately. Men treated or enrolled on this protocol must also agree to use two forms of\r\n contraception prior to the study, for the duration of study participation, and for 3 months\r\n after completion of administration of both ganetespib and ziv-aflibercept.\r\n\r\n Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n During the escalation phase of the protocol, patients may have evaluable or measurable\r\n disease. During the expansion phase of the protocol, patients must have 1) measurable\r\n disease, 2) disease amenable to biopsy and 3) willingness to undergo pre- and\r\n post-treatment biopsies.\r\n\r\n EXCLUSION CRITERIA:\r\n\r\n Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas\r\n or mitomycin C) prior to entering the study or those who have not recovered from adverse\r\n events due to agents administered more than 3 weeks earlier.\r\n\r\n Patients who are receiving any other investigational agents.\r\n\r\n Patients with known active brain metastases or carcinomatous meningitis are excluded from\r\n this clinical trial. Patients whose brain metastatic disease status has remained stable for\r\n greater than or equal to 4 weeks following treatment of brain metastases are eligible to\r\n participate at the discretion of the principal investigator.\r\n\r\n Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n untreated infection, or psychiatric illness/social situations that would limit compliance\r\n with study requirements.\r\n\r\n Patients with known serious cardiac illness or medical conditions, including but not\r\n\r\n limited to:\r\n\r\n - Clinically unstable cardiac disease, including unstable atrial fibrillation,\r\n symptomatic bradycardia, unstable congestive heart failure, unstable angina or history\r\n of myocardial infarct within 6 months prior to enrollment, or indwelling temporary\r\n pacemaker\r\n\r\n - Ventricular tachycardia or a supraventricular tachycardia that requires treatment with\r\n antiarrhythmic agents\r\n\r\n - Second- or third-degree atrioventricular block unless treated with a permanent\r\n pacemaker\r\n\r\n - Complete left bundle branch block\r\n\r\n - History of long Q wave, T wave (QT) syndrome or a family member with this condition\r\n\r\n No major surgery within 4 weeks prior to enrollment or history of gastrointestinal bleeding\r\n within 3 months prior to enrollment. No signs or symptoms of active bleeding or nonhealing\r\n ulcer will be permitted at study entry. Patients with central pulmonary tumors with\r\n evidence of bronchial invasion, or presenting with hemoptysis will be excluded.\r\n\r\n Corrected QT interval (QTc) > 470 msec on electrocardiogram (by Bazett's; average of\r\n triplicate recordings at the discretion of the principal investigator (PI) will exclude\r\n patients from entry on study. Medications that are known to cause QTc interval prolongation\r\n are prohibited for patients entering on trial. Patients for whom a given medication that\r\n may cause QTc interval prolongation cannot be discontinued, may be eligible at the\r\n discretion of the study PI, provided QTc interval criteria is met at enrollment. A\r\n comprehensive list of agents with the potential to cause QTc prolongation can be found in\r\n Appendix C and at http://crediblemeds.org.\r\n\r\n Pregnant women and women who are breastfeeding are excluded from this study because the\r\n effects of the study drugs on the developing fetus are unknown.\r\n\r\n Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy\r\n are ineligible because of the potential for pharmacokinetic interactions with ganetespib\r\n and zivaflibercept. In addition, these patients are at increased risk of lethal infections\r\n when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in\r\n patients receiving combination antiretroviral therapy when indicated.\r\n\r\n Substrates of cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19):\r\n\r\n - Preliminary results of a clinical drug-drug interaction study, examining the effect of\r\n ganetespib on the pharmacokinetics of the CYP2C19-sensitive probe omeprazole, show a\r\n modest (20%) increase in omeprazole exposure when coadministered with ganetespib.\r\n\r\n - In vitro data implies expectation of greater interaction with CYP2C19 substrates than\r\n with CYP3A4 substrates.\r\n\r\n - Caution is advised when sensitive narrow therapeutic range CYP3A4 or CYP2C19\r\n substrates are concomitantly administered.\r\n\r\n Inhibitors of P-Glycoprotein Efflux Transporters: Concomitant medications that are strong\r\n inhibitors of P-glycoprotein efflux transporters should be used with caution during the\r\n study; examples of these medications include:\r\n\r\n - ritonavir,\r\n\r\n - cyclosporine,\r\n\r\n - verapamil,\r\n\r\n - erythromycin,\r\n\r\n - ketoconazole,\r\n\r\n - itraconazole,\r\n\r\n - quinidine, and\r\n\r\n - elacridar.\r\n\r\n Concurrent anticoagulation will be permitted providing the patient is receiving a stable\r\n dose of anticoagulants before study entry. Patients receiving anticoagulants will be\r\n eligible for this trial. Evidence of clinically significant bleeding diathesis or\r\n underlying coagulopathy (e.g., INR > 1.5 without vitamin K antagonist therapy) will not be\r\n permitted.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Ziv-Aflibercept', 'Ganetespib']\n- **Description:** ['Ziv-aflibercept is a soluble fusion protein with high binding affinity for vascular endothelial growth factor A (VEGF-A), vascular endothelial growth factor B (VEGF-B), and placenta growth factor (PIGF) and thus confers anti-angiogenic activity', 'Ganetespib is a non-geldamycin synthetic inhibitor of Hsp90 with activity against multiple cancer cell lines and tumor xenografts in preclinical models.']\n- **Mesh Terms:** Aflibercept\nSMILES: ['CC(C)C1=C(O)C=C(O)C(=C1)C1=NNC(=O)N1C1=CC2=C(C=C1)N(C)C=C2']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
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NCT02866721
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic Fibrosis\n\n**Trial Summary:** \n\n\n This study is being done to test if it is safe to give stem cells to adult patients with\r\n Cystic Fibrosis (CF). The kind of stem cells we are studying are called allogeneic human\r\n mesenchymal stem cells or MSCs. MSCs are cells in the body that can grow into different types\r\n of cells and respond to various environmental situations. Allogeneic means the cells come\r\n from another person (a donor).\r\n\r\n This study is only looking at whether or not it is safe to give the stem cells to adults with\r\n CF and how the infusion is tolerated. In the future, other studies may be done to see if stem\r\n cells can be a new therapeutic treatment for CF.\r\n\r\n Stem cells, like other medical products that are intended to treat, cure or prevent disease,\r\n generally require approval from the U.S. Food and Drug Administration (FDA) before they can\r\n be marketed. The FDA has not approved any stem cell-based products for usual medical care,\r\n other than some specific blood forming stem cells for certain indications.\r\n \n\n**Trial Keywords:** Human Mesenchymal Stem Cells\n\n**Phase:** Phase 1\n\n**Condition:** Cystic Fibrosis\n\n**Condition Keywords:** ['Cystic Fibrosis', 'Fibrosis']\n\n**ICD Code:** [\"['E84.9', 'Z14.1', 'E84.0', 'E84.11', 'E84.8', 'E84.19', 'P09.4']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Cystic Fibrosis (CF) Subject Inclusion Criteria:\r\n\r\n 1. Male or female ≥18 years of age\r\n\r\n 2. Confirmed diagnosis of CF as evidenced by 1 or more clinical features consistent with\r\n the CF phenotype and 1 or more of the following criteria:\r\n\r\n 1. Sweat chloride equal to or greater than 60 milliequivalents per liter (mEq/L) by\r\n quantitative pilocarpine iontophoresis test (QPIT)\r\n\r\n 2. 2 well-characterized, disease causing mutations in the cystic fibrosis\r\n transmembrane conductance regulator (CFTR) gene\r\n\r\n 3. Clinically stable with no significant changes in health status within 2 weeks prior to\r\n screening.\r\n\r\n 4. Forced expiratory volume in the first second (FEV1) ≥ 40% predicted for age based on\r\n the global lung function initiative equations at the screening visit\r\n\r\n 5. Weight ≥ 40 kilograms at the screening visit\r\n\r\n 6. Able to perform repeatable, consistent efforts in pulmonary function testing\r\n\r\n 7. Written informed consent obtained from the subject.\r\n\r\n CF Subject Exclusion Criteria:\r\n\r\n 1. Use of an investigational agent within the 4-week period prior to Visit 1 (Day -42 to\r\n -10)\r\n\r\n 2. Chronic daily (>10 mg) or alternate daily (>20 mg on alternate days) use of systemic\r\n corticosteroids within the 4 weeks prior to Visit 1 (Day -42 to -10) or initiation of\r\n any dosage of systemic corticosteroids within 72 hours prior to Visit 2 (Day 1).\r\n\r\n 3. Use of hydroxychloroquine or immunosuppressants.\r\n\r\n 4. Initiation of a new antibiotic (oral, intravenous, and/or inhaled) that is not part of\r\n the subject's maintenance regimen for treatment of acute respiratory symptoms within 2\r\n weeks prior to screening through Visit 2 (Day 1)\r\n\r\n 5. Initiation of any new chronic therapy (e.g., Pulmozyme®, hypertonic saline, Kalydeco®,\r\n Orkambi®, high-dose ibuprofen azithromycin, TOBI®, Cayston®, nebulized colistiin,\r\n bronchodilators, inhaled corticosteroids, etc.) within 4 weeks prior to screening\r\n\r\n 6. Active treatment for non-tuberculous Mycobacteria\r\n\r\n 7. History of a sputum culture positive for a Burkholderia cepacia complex organism in\r\n the previous 12 months.\r\n\r\n 8. Current tobacco smoker\r\n\r\n 9. Oxygen saturation < 92% on room air at Visit 1 (Day -42 to -10)\r\n\r\n 10. History of pulmonary hypertension\r\n\r\n 11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the\r\n upper limit of normal at screening, documented biliary cirrhosis, or portal\r\n hypertension\r\n\r\n 12. Total bilirubin concentration > 1.2 milligram per deciliter (mg/dL) at screening\r\n\r\n 13. Creatinine > 1.8 mg/dL at screening\r\n\r\n 14. Pregnant, breastfeeding, or unwilling to practice birth control between Visit 2 (Day\r\n 1) and Telephone Call 3 (Day 56) (acceptable forms of contraception: abstinence,\r\n hormonal birth control, intrauterine device, or barrier method plus a spermicidal\r\n agent), unless surgically sterilized or postmenopausal\r\n\r\n 15. Screening hematology with white blood cell count < 4.5 x 109 cells/liter, hematocrit <\r\n 30%, and platelets < 150 x 109 platelets/liter\r\n\r\n 16. History of invasive cancer requiring systemic therapy\r\n\r\n 17. History of organ transplantation\r\n\r\n 18. Currently listed for lung transplantation or having potential to be listed for lung\r\n transplantation in the succeeding 12 calendar months from screening\r\n\r\n 19. Subject unlikely to complete the study as determined by the Investigator\r\n\r\n Inclusion Criteria for Healthy Volunteer Donors (NOTE: Enrollment for Healthy Volunteers is\r\n closed):\r\n\r\n 1. Male/female age ≥ 18 years to ≤ 40 years\r\n\r\n 2. Able to understand and sign consent form (a legally authorized representative will not\r\n be permitted)\r\n\r\n Inclusion Criteria for CF Donors:\r\n\r\n 1. CF subject enrolled in the main study and consented to this optional procedure\r\n\r\n Exclusion Criteria for both Healthy Volunteer (HV) Donors and CF Donors:\r\n\r\n 1. Fever or current illness on the day of the cell collection\r\n\r\n 2. Evidence of communicable disease\r\n\r\n 3. Any significant change in health status within 2 weeks prior to cell collection that\r\n the Principal Investigator/Sub-Investigator deems relevant to exclude participation\r\n\r\n 4. Subject reported history of organ transplantation\r\n\r\n 5. Subject reported history of human immunodeficiency virus, hepatitis B or C, or\r\n syphilis\r\n\r\n 6. For HV donors only, subject-reported known history of being diagnosed with cystic\r\n fibrosis (CF) or being a CF carrier (one copy of CF gene mutation)\r\n\r\n 7. Positive screening blood test result for any infectious disease.\r\n\r\n 8. For HV donors only, positive test result for CMV or a CF gene mutation.\r\n\r\n 9. Pregnant, planning a pregnancy, or breast-feeding at screening\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Mesenchymal Stem Cells\n- **Description:** A single dose, one time infusion (in the vein) of one of the following doses of human mesenchymal stem cells (hMSCs): 1 x 10^6, 3 x 10^6 or 5 x 10^6 human mesenchymal stem cells per kilogram body weight (hMSCs/kg) during Visit 2. A traditional 3+3 design will be utilized.\r\nAllogeneic mesenchymal stem cells (MSCs) will be derived from bone marrow aspirates from a healthy donor whose serum tests negative for cytomegalovirus (CMV) antibodies. Healthy donors will undergo tests for infectious disease and screening for 41 common cystic fibrosis transmembrane conductance regulator (CFTR) mutations. In addition, the MSCs will be validated for in vitro and in vivo efficacy and potency using the in vivo murine pre-clinical model of cystic fibrosis lung infection and inflammation.\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03961100
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.\n\n**Trial Summary:** \n\n\n This study will evaluate the bioavailability, palatability, safety and tolerability of\r\n entrectinib in healthy volunteers. Part 1 of the study will explore the performance of\r\n entrectinib multi-particle formulation. Part 2 will evaluate the effect of drug substance\r\n particle size on entrectinib bioavailability.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Solid Tumor\n\n**Condition Keywords:** None\n\n**ICD Code:** ['None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 60 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - A body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m2),\r\n inclusive, and weighing >/=50 kg.\r\n\r\n - Agreement to comply with measures to prevent pregnancy and restrictions on egg and\r\n sperm donation\r\n\r\n Exclusion Criteria:\r\n\r\n - Women of childbearing potential, women who are pregnant or breastfeeding, or intending\r\n to become pregnant during the study or within 14 days after the final dose of\r\n entrectinib or have a pregnant partner\r\n\r\n - A clinical significant medical history of gastrointestinal surgery (e.g., gastric\r\n bypass) or other gastrointestinal disorder (e.g., malabsorption syndrome) that might\r\n affect absorption of medicines from the gastrointestinal tract\r\n\r\n - Presence of a clinically significant disease, illness, medical condition or disorder,\r\n or any other medical history determined by the investigator to be clinically\r\n significant and relevant\r\n\r\n - Clinically significant change in health status, or any major illness, or clinically\r\n significant acute infection or febrile illness\r\n\r\n - Use of moderate or potent inhibitors or inducers of CYP P450 3A4 enzyme or P-gp\r\n transporter, or use of other prohibited medications\r\n\r\n - Participation in any other clinical study involving an investigational medicinal\r\n product (IMP) or device\r\n\r\n - A positive test result for hepatitis B, hepatitis C (HCV), or human immunodeficiency\r\n virus (HIV)\r\n\r\n - Current smokers and those who have smoked, or users of e-cigarettes and nicotine\r\n replacement products within the last 12 months\r\n\r\n - Known history of clinically significant hypersensitivity, or severe allergic reaction,\r\n to entrectinib or related compounds\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Entrectinib 600 mg (T1)', 'Entrectinib 600 mg (T2)', 'Entrectinib 200 mg (R)', 'Entrectinib 200 mg (T)']\n- **Description:** ['Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets', 'Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets', 'Reference formulation (R): entrectinib hard capsules', 'Test formulation (T): entrectinib HPMC capsules']\n- **Mesh Terms:** Entrectinib\nSMILES: ['CN1CCN(CC1)C1=CC=C(C(=O)NC2=NNC3=CC=C(CC4=CC(F)=CC(F)=C4)C=C23)C(NC2CCOCC2)=C1', 'CN1CCN(CC1)C1=CC=C(C(=O)NC2=NNC3=CC=C(CC4=CC(F)=CC(F)=C4)C=C23)C(NC2CCOCC2)=C1', 'CN1CCN(CC1)C1=CC=C(C(=O)NC2=NNC3=CC=C(CC4=CC(F)=CC(F)=C4)C=C23)C(NC2CCOCC2)=C1', 'CN1CCN(CC1)C1=CC=C(C(=O)NC2=NNC3=CC=C(CC4=CC(F)=CC(F)=C4)C=C23)C(NC2CCOCC2)=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02919696
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers\n\n**Trial Summary:** \n\n\n The purpose of this study is to determine the safety of the study drug known as abemaciclib\r\n in native Chinese participants with advanced and/or metastatic cancers.\r\n \n\n**Trial Keywords:** CDK4/6 Inhibitor\n\n**Phase:** Phase 1\n\n**Condition:** ['Advanced Cancer', 'Metastatic Cancer']\n\n**Condition Keywords:** ['Neoplasm Metastasis', 'Neoplasms', 'Neoplasms, Second Primary']\n\n**ICD Code:** [\"['K74.02', 'G47.22', 'H35.3133', 'H35.3134', 'H35.3113', 'H35.3114', 'H35.3123']\", \"['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** None\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - The participant must have histological or cytological evidence of cancer which is\r\n advanced and/or metastatic, and is an appropriate candidate for experimental therapy\r\n in the judgment of the investigator, after available standard therapies have ceased to\r\n provide clinical benefit.\r\n\r\n - Have the presence of measureable disease as defined by the Response Evaluation\r\n Criteria in Solid Tumors (RECIST 1.1).\r\n\r\n - Are native Chinese men or women.\r\n\r\n - Have adequate organ function, including:\r\n\r\n - Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 109/Liters (L), platelets\r\n ≥100 x 109/L, and hemoglobin ≥9 grams per deciliter. Participants may receive\r\n erythrocyte transfusions to achieve this hemoglobin level or platelet\r\n transfusions to achieve platelet levels at the discretion of the investigator;\r\n however, initial study drug treatment must not begin earlier than the day after\r\n transfusion.\r\n\r\n - Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN), alanine\r\n aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3.0 times ULN.\r\n\r\n - Renal: Serum creatinine ≤1.2 milligrams per deciliter (mg/dL) for males or ≤1.0\r\n mg/dL for females.\r\n\r\n - Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.\r\n\r\n - Recovered from the acute effects of therapy (treatment- related toxicity resolved to\r\n baseline) except for residual alopecia.\r\n\r\n - Have an estimated life expectancy of ≥12 weeks.\r\n\r\n Exclusion Criteria:\r\n\r\n - Have received previous therapies for cancer (including chemotherapy, radiotherapy,\r\n immunotherapy, and investigational therapy) within 21 days for myelosuppressive agents\r\n or 14 days for nonmyelosuppressive agents prior to receiving study drug.\r\n\r\n - Have an acute leukemia or other relevant cancers at the discretion of the\r\n investigator.\r\n\r\n - Females who are pregnant or lactating.\r\n\r\n - Participants consuming drugs or foods that are known to be inducers (for example,\r\n grapefruit juice, phenytoin, carbamazepine) or strong inhibitors of CYP3A4 should be\r\n excluded during Cycle 1.\r\n\r\n - Have history or evidence of central nervous system (CNS) malignancy or metastasis.\r\n Screening of asymptomatic participants without history of CNS metastases is not\r\n required for enrollment.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** Abemaciclib\n- **Description:** Administered orally\n- **Mesh Terms:** None\nSMILES: ['CCN1CCN(CC2=CC=C(NC3=NC=C(F)C(=N3)C3=CC(F)=C4N=C(C)N(C(C)C)C4=C3)N=C2)CC1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03070171
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nBioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects\n\n**Trial Summary:** \n\n\n The primary objective of this trial is to establish the bioequivalence of tablet formulation\r\n of dabigatran etexilate compared to commercial capsule formulation following oral\r\n administration under fasted condition.\r\n\r\n The secondary objective is the evaluation and comparison of several pharmacokinetic\r\n parameters between the treatments.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 20 Years\n- **Maximum Age:** 40 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n Subjects will only be included into the trial, if they meet the following criteria:\r\n\r\n - Healthy male subjects according to the investigator's assessment, based on a complete\r\n medical history including a physical examination, vital signs (blood pressure (BP),\r\n pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests\r\n\r\n - Age ≥20 and ≤40 years old at informed consent\r\n\r\n - BMI ≥18 and ≤25 kg/m2 at screening\r\n\r\n - Signed and dated written informed consent prior to admission to the trial in\r\n accordance with Good Clinical Practice (GCP) and local legislation\r\n\r\n Exclusion Criteria:\r\n\r\n Subjects will not be allowed to participate if any of the following general criteria apply:\r\n\r\n - Any finding in the medical examination (including blood pressure (BP), pulse rate\r\n (PR)or electrocardiogram (ECG)) is deviating from normal and judged as clinically\r\n relevant by the investigator\r\n\r\n - Measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic\r\n blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of\r\n 45 to 90 bpm at screening. Based on the clinical judge by the investigator, repeated\r\n measurements are allowed.\r\n\r\n - Any laboratory value outside the reference range before randomisation that the\r\n investigator considers to be of clinical relevance\r\n\r\n - Any evidence of a concomitant disease considered as clinically relevant by the\r\n investigator\r\n\r\n - Any relevant bleeding history considered by the investigator\r\n\r\n - Any history or evidence of blood dyscrasia, haemorrhagic diathesis, severe\r\n thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with\r\n active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary\r\n tract or any disease or condition with haemorrhagic tendencies\r\n\r\n - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,\r\n immunological or hormonal disorders\r\n\r\n - Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with\r\n the pharmacokinetics of the trial medication (except appendectomy and simple hernia\r\n repair)\r\n\r\n - Planned surgeries within four weeks following the end-of trial examination\r\n\r\n - Diseases of the central nervous system (including but not limited to any kind of\r\n seizures or stroke), and other relevant neurological or psychiatric disorders\r\n\r\n - History of relevant orthostatic hypotension, fainting spells, or blackouts\r\n\r\n - Chronic or relevant acute infections\r\n\r\n - History of relevant allergy or hypersensitivity (including allergy to the trial\r\n medication or its excipients)\r\n\r\n - Use of drugs within 30 days prior to administration of trial medication if that might\r\n reasonably influence the results of the trial (incl.Qc/QTc interval prolongation)\r\n\r\n - Participation in another trial where an investigational drug has been administered\r\n within 60 days prior to planned administration of trial medication, or current\r\n participation in another trial involving administration of investigational drug\r\n\r\n - Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)\r\n\r\n - Inability to refrain from smoking in-house confinement at the trial site\r\n\r\n - Alcohol abuse (consumption of more than 30 g per day: e.g., 750 mL of beer, 1.5 gous\r\n [equivalent to 270 mL] of Sake)\r\n\r\n - Drug abuse or positive drug screening\r\n\r\n - Blood donation of more than 100 mL within 30 days prior to administration of trial\r\n medication or intended donation during the trial\r\n\r\n - Intention to perform excessive physical activities within one week prior to\r\n administration of trial medication or during the trial\r\n\r\n - Inability to comply with dietary regimen of trial site\r\n\r\n - Subject is assessed as unsuitable for inclusion by the investigator, for instance,\r\n because considered not able to understand and comply with trial requirements, or has a\r\n condition that would not allow safe participation in the trial\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** dabigatran etexilate\n- **Description:** single dose\n- **Mesh Terms:** Dabigatran\nSMILES: ['CCCCCCOC(=O)\\\\N=C(\\\\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT03693950
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nThe Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers\n\n**Trial Summary:** \n\n\n BCD-066 is a darbepoetin alfa. Clinical study BCD-066-3 is a double-blind controlled,\r\n randomized, parallel-group study of the pharmacokinetics, pharmacodynamics, tolerability, and\r\n safety of multiple intravenous injections of BCD-066 and Aranesp®.\r\n\r\n The purpose of the study is to confirm the equivalent pharmacokinetics, pharmacodynamics,\r\n safety, and tolerability of multiple IV injections of BCD-066 and Aranesp® in healthy\r\n volunteers.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Healthy\n\n**Condition Keywords:** None\n\n**ICD Code:** [\"['Z76.3', 'Z76.2']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 45 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Signed informed consent form\r\n\r\n 2. Men from 18 to 45 years old (inclusive)\r\n\r\n 3. BMI within the normal limits (18.5 to 30 kg/m2)\r\n\r\n 4. Hemoglobin from 120 g/L to 150 g/L and hematocrit 41% to 49% at screening (before the\r\n first injection)\r\n\r\n 5. Serum transferring 2.15 g/L to 3.6 g/L; serum ferritin from 20 μg/L to 250 μg/L\r\n\r\n 6. Vitamin B12 from 187 pcg/mL to 883 pcg/mL; folic acid from 3.1 ng/mL to 20.5 ng/mL\r\n\r\n 7. Endogenous serum erythropoietin < 30 mIU/mL at screening\r\n\r\n 8. The subject is verified as \"Healthy\" according to results of standard clinical,\r\n laboratory and instrumental tests\r\n\r\n 9. Subject's ability (in the investigator's opinion) to follow the protocol procedures\r\n\r\n 10. The subject and his sexual partner with retained childbearing potential consent to\r\n implement reliable contraceptive methods starting 2 weeks before inclusion in the\r\n study and up to 2 weeks after the last dose of the test/reference drug. This\r\n requirement does not apply to surgically sterile subjects. Reliable contraception\r\n methods mean one barrier method in combination with one of the following: spermicides,\r\n intrauterine device and/or oral contraceptives used by the subject's partner.\r\n\r\n 11. The subject agrees not to drink alcohol for 24 h prior to each injection of the\r\n test/reference drug and for 72 h after the injection.\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Psychiatric disorders or other conditions that can affect the ability of the subject to\r\n follow the study protocol 2. Acute infections within 4 weeks before the study start 3.\r\n Results of laboratory and/or instrumental tests are outside the normal range 4. Chronic\r\n cardiovascular, bronchial and/or pulmonary, neuroendocrine GI, liver, kidney, and blood\r\n diseases, including ischemic heart disease, arterial hypertension, peripheral vascular\r\n and/or cerebral vascular disorders, and thrombocytosis 5. A history of chronic hemorrhages\r\n\r\n -\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['BCD-066', 'Aranesp']\n- **Description:** ['BCD-066 will be administered once a week intravenously in a dose 1 µg/kg', 'Aranesp will be administered once a week intravenously in a dose 1 µg/kg']\n- **Mesh Terms:** Darbepoetin alfa\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04053023
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nLinerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects\n\n**Trial Summary:** \n\n\n In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking\r\n obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC],\r\n OCA, or both) the addition of linerixibat to OCA therapy may be considered following\r\n marketing approval. It is therefore important to characterize any potential effect of\r\n linerixibat on the pharmacokinetics of OCA in humans at clinically relevant dosages.\r\n Accordingly, a drug-drug interaction (DDI) study with linerixibat (potential perpetrator) and\r\n OCA (potential victim) will be conducted to inform both future clinical trials with\r\n linerixibat and the potential concomitant administration of these drugs in a clinical\r\n setting. This is a single-center, one part (with optional second part) open-label, single\r\n sequence crossover, drug interaction study to investigate the effect of linerixibat on plasma\r\n concentrations of OCA and OCA conjugates in healthy participants. Approximately 19\r\n participants will be enrolled in part A and further 19 participants in part B (if performed)\r\n in the study and will have a phone call follow-up till 7-14 days post-last linerixibat dose.\r\n \n\n**Trial Keywords:** linerixibat (GSK2330672), obeticholic acid, drug interaction, primary biliary cholangitis, pharmacokinetics\n\n**Phase:** Phase 1\n\n**Condition:** Cholestasis\n\n**Condition Keywords:** Cholestasis\n\n**ICD Code:** [\"['K71.0', 'O26.641', 'O26.642', 'O26.643', 'O26.649']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 80 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Between 18 and 80 years of age inclusive, at the time of signing the informed consent.\r\n\r\n - Healthy, as determined by the investigator or medically qualified designee, based on a\r\n medical evaluation including medical history, physical examination, vital signs,\r\n laboratory tests, and ECG. A participant with a clinical abnormality or laboratory\r\n parameter (i.e., outside the reference range for the population being studied), which\r\n is not specifically listed in the eligibility criteria, may be included only if the\r\n investigator agrees in consultation with the GlaxoSmithKline (GSK) medical monitor and\r\n documents in the source documentation that the finding is unlikely to introduce\r\n additional risk factors and will not interfere with the study procedures or outcomes.\r\n\r\n - Body weight > 50 kilogram (kg) and body mass index (BMI) within the range 18.5 to 32\r\n kg per square meter (inclusive).\r\n\r\n - Capable of giving signed informed consent which includes compliance with the\r\n requirements and restrictions listed in the informed consent form (ICF) and protocol.\r\n\r\n - Male and female- A female participant is eligible to participate if she is not\r\n pregnant not breastfeeding, and at least one of the following conditions applies; not\r\n a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow\r\n contraceptive guidance during the treatment period and until at least 4 weeks after\r\n the last dose of study treatment. The investigator is responsible for review of\r\n medical history, menstrual history, and recent sexual activity to decrease the risk\r\n for inclusion of a woman with an early undetected pregnancy.\r\n\r\n Exclusion Criteria:\r\n\r\n - Any active dermatologic disorder leading to or with the potential to cause pruritus or\r\n a recent history of unexplained clinically significant itching locally or generally\r\n within the prior 3 months\r\n\r\n - Current or chronic history of liver disease, or known hepatic or biliary abnormalities\r\n (with the exception of Gilbert's syndrome or asymptomatic gallstones) and/or confirmed\r\n hepatocellular carcinoma or biliary cancer\r\n\r\n - Participants with a history of cholecystectomy\r\n\r\n - Current symptomatic cholelithiasis or inflammatory gall bladder disease\r\n\r\n - Significant history of or current cardiovascular, respiratory, hepatic, renal,\r\n gastrointestinal, endocrine, hematological, or neurological disorders capable of\r\n significantly altering the absorption, metabolism, or elimination of drugs;\r\n constituting a risk when taking the study intervention; or interfering with the\r\n interpretation of data\r\n\r\n - Any clinically relevant abnormality identified at the screening medical assessment\r\n (physical examination/medical history) clinical laboratory tests, or 12-lead ECG\r\n\r\n - Current episode, recent history (within 1 month of screening visit), or chronic\r\n history of clinically significant diarrhea\r\n\r\n - Lymphoma, leukaemia, or any malignancy within the past 5 years except for basal cell\r\n or squamous epithelial carcinomas of the skin that have been resected with no evidence\r\n of metastatic disease for 3 years\r\n\r\n - Any current medical condition (e.g. psychiatric disorder, senility, dementia, or other\r\n condition), clinical or laboratory abnormality, or examination finding that the\r\n investigator considers would put the participant at unacceptable risk, which may\r\n affect study compliance or prevent understanding of the aims or investigational\r\n procedures or possible consequences of the study\r\n\r\n - Regular use of known drugs of abuse or history of drug abuse or dependence within 6\r\n months of the study\r\n\r\n - Regular alcohol consumption within 6 months prior to the study defined as an average\r\n weekly intake of >14 units for females and >21 units for males. One unit is equivalent\r\n to 8 gram of alcohol: a glass (approximately [~] 240 milliliter [mL]) of beer, 1 small\r\n glass (~100 mL) of wine or 1 (~25 mL) measure of spirits\r\n\r\n - History of or regular use of tobacco- or nicotine-containing products (confirmed by\r\n smokerlyzer test) in the 3 months prior to screening.\r\n\r\n - Administration of any IBAT inhibitor (including linerixibat) or OCA in the 3 months\r\n prior to screening\r\n\r\n - Past or intended use of over-the-counter or prescription medication (including\r\n vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a\r\n potential enzyme inhibitor) or 5 half-lives (whichever is longer) prior to the first\r\n dose of study medication, unless approved by the investigator in conjunction with GSK\r\n medical monitor.\r\n\r\n - Current enrollment in a clinical trial, recent participation in a clinical trial and\r\n has received an investigational product within 30 days (or 5 half-lives of previous\r\n trial intervention, whichever is longer) before the first dose in the current study\r\n\r\n - Exposure to more than 4 new chemical entities within 12 months before the first dose\r\n in the current study.\r\n\r\n - Screening ALT or AST >1.5 times the upper limit of normal (ULN)\r\n\r\n - Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin\r\n is fractionated and direct bilirubin <35%)\r\n\r\n - Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C\r\n antibody test result at screening or within 3 months of the screening visit\r\n\r\n - Positive serum pregnancy test at screening or positive urine pregnancy test at\r\n admission in WOCBP only\r\n\r\n - Positive human immunodeficiency virus (HIV) antibody test\r\n\r\n - QTc >450 millisecond (msec) on ECG performed at screening.\r\n\r\n - Positive pre-study drug/alcohol screen or positive drug/alcohol screen at any time\r\n during the study.\r\n\r\n - Female participants unable or unwilling to comply with specific contraception\r\n restrictions.\r\n\r\n - Where participation in the study would result in donation of blood or blood products\r\n in excess of 500 mL within a 56-day period.\r\n\r\n - Unwillingness or inability to follow the procedures outlined in the protocol for the\r\n expected duration of study participation.\r\n\r\n - Sensitivity to any of the study interventions, or components thereof, or drug or other\r\n allergy that, in the opinion of the investigator or medical monitor, contraindicates\r\n participation in the study.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['GSK2330672 (linerixibat)', 'Obeticholic acid']\n- **Description:** ['GSK2330672 is available as a tablet with unit dose strength of 45 mg.', 'Obeticholic acid is available as a tablet with a unit dose strength of 10 mg (or 5 mg dependent on evaluation of Part A).']\n- **Mesh Terms:** None\nSMILES: ['[H][C@@]1(CC[C@@]2([H])[C@]3([H])[C@H](O)[C@H](CC)[C@]4([H])C[C@H](O)CC[C@]4(C)[C@@]3([H])CC[C@]12C)[C@H](C)CCC(O)=O']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02664363
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEGFRvIII CAR T Cells for Newly-Diagnosed WHO Grade IV Malignant Glioma\n\n**Trial Summary:** \n\n\n Please note that enrollment on this study terminated early due to the end of grant funding.\r\n\r\n Newly diagnosed WHO grade IV malignant glioma subjects who are eligible were enrolled\r\n following surgery to remove their brain tumor. They then underwent a leukapheresis to harvest\r\n cells for the generation of the study drug, Epidermal Growth Factor variant III Chimeric\r\n Antigen Receptor (EGFRvIII CAR) T cells prior to beginning standard of care (SOC) radiation\r\n therapy (RT) with temozolomide (TMZ). Once SOC RT with TMZ was completed, subjects returned\r\n for the post-RT brain imaging assessment, and, if stable, started post-RT TMZ cycles.\r\n Patients received up to 3 cycles of dose-intensified TMZ prior to receiving the EGFRvIII CAR\r\n T cells, which was infused in dose escalation cohorts. Following a one-month delay between\r\n cycles, the subject resumed post-RT cycles of TMZ and were monitored with blood work and\r\n brain imaging as per SOC.\r\n\r\n An expanded cohort of 12 subjects was originally planned for once the maximally tolerated\r\n dose (MTD) was reached in the dose escalation cohorts, in order to obtain a more precise\r\n estimate of the probability of unacceptable toxicity and to track the EGFRvIII CAR T cells\r\n using 111 Indium (111In) labeling. Computed Tomography (CT) was planned on days 1, 2, and 3\r\n post-infusion to determine intracerebral (IC) localization.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Glioblastoma', 'Gliosarcoma']\n\n**Condition Keywords:** ['Glioblastoma', 'Gliosarcoma']\n\n**ICD Code:** ['None', 'None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 80 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n 1. Age 18-80 years of age\r\n\r\n 2. Histopathologically proven newly-diagnosed, supratentorial glioblastoma or gliosarcoma\r\n (World Health Organization [WHO] Grade IV)\r\n\r\n 3. Karnofsky Performance Status (KPS) score ≥ 70\r\n\r\n 4. The presence of the target antigen, EGFRvIII, must be identified on tumor tissue by\r\n immunohistochemistry (IHC) or Polymerase Chain Reaction (PCR).\r\n\r\n 5. Hematology:\r\n\r\n - Absolute Neutrophil Count (ANC) ≥ 1000/mm^3 without the support of filgrastim\r\n\r\n - Platelet count ≥ 100,000/mm^3\r\n\r\n - Hemoglobin ≥ 8.0 g/dl (eligibility level for hemoglobin may be reached with\r\n transfusion)\r\n\r\n 6. Chemistry:\r\n\r\n - Alanine Amino Transferase (ALT)/Aspartate Amino Transferase (AST) ≤ 2.5 times the\r\n upper limit of normal\r\n\r\n - Creatinine ≤ 1.6 mg/dl\r\n\r\n - Total bilirubin ≤ 1.5 mg/dl\r\n\r\n Exclusion Criteria:\r\n\r\n 1. Patients who are pregnant, breast-feeding, or unwilling to practice an effective\r\n method of birth control\r\n\r\n 2. Patients with known potentially anaphylactic allergic reactions to\r\n Gadolinium-Diethylene Triamine Pentaacetic Acid (gd-DTPA)\r\n\r\n 3. Patients who cannot undergo Magnetic Resonance Imaging (MRI) or Single Photon\r\n Emission-Computed Tomography (SPECT) due to obesity or to having certain metal in\r\n their bodies (specifically pacemakers, infusion pumps, metal aneurysm clips, metal\r\n prostheses, joints, rods, or plates)\r\n\r\n 4. Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, or with\r\n evidence of leptomeningeal disease\r\n\r\n 5. Active infection requiring treatment or an unexplained febrile (> 101.5 F) illness\r\n\r\n 6. Known autoimmune disease, immunosuppressive disease or human immunodeficiency virus\r\n (HIV) infection (i.e., known HIV or Hepatitis C)\r\n\r\n 7. Patients with unstable or severe intercurrent medical conditions such as severe heart\r\n or lung disease\r\n\r\n 8. Patients with previous history of radiosurgery, brachytherapy, gliadel implantation,\r\n or radiolabeled monoclonal antibodies\r\n\r\n 9. Prior antitumor therapy for glioma (other than steroids)\r\n\r\n 10. Allergic to TMZ\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** EGFRvIII CAR T cells\n- **Description:** The name of the drug is CAR gene-modified T cells or abbreviated as EGFRvIII CARs. The class of action is a biological and the mechanism of action is cytotoxicity. The drug substance is autologous T cells transduced with a retroviral vector encoding for a chimeric antigen receptor (CAR) directed against the tumor specific antigen, EGFRvIII. EGFRvIII CARs are genetically engineered T cells that have been taken from patients with GBM ex vivo to express a CAR recognizing the GBM tumor-specific antigen EGFRvIII, which is expressed on a subset of GBMs but not in normal human tissues with the aim of mediating regression of their tumors. Patients' CARs will be radiolabeled with 111In for correlative studies in the expanded cohort.\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT03451422
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nSafety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus\n\n**Trial Summary:** \n\n\n To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of\r\n Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).\r\n \n\n**Trial Keywords:** ['Efavaleukin Alfa', 'Systemic lupus erythematosus', 'Phase 1b']\n\n**Phase:** Phase 1\n\n**Condition:** Systemic Lupus Erythematosus\n\n**Condition Keywords:** Lupus Erythematosus, Systemic\n\n**ICD Code:** [\"['M32.9', 'M32.0', 'M32.11', 'M32.12', 'M32.13', 'M32.14', 'M32.8']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 70 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n Participants are eligible to be included in the study only if all of the following criteria\r\n apply:\r\n\r\n - Participant has provided informed consent prior to initiation of any study specific\r\n activities/procedures.\r\n\r\n - Age ≥ 18 years to ≤ 70 years at screening.\r\n\r\n - Fulfills diagnostic criteria for SLE according to the Systemic Lupus International\r\n Collaborating Clinics (SLICC) criteria or by at least 4 of the 11 criteria of the 1997\r\n American College of Rheumatology (ACR) classification criteria for SLE, with a history\r\n of at least one of the following:\r\n\r\n - Antinuclear antibody ≥ 1:80; or\r\n\r\n - Elevated anti-dsDNA antibodies\r\n\r\n - May be taking ≤ 3 systemic SLE treatments and the dose must be stable for ≥ 4 weeks\r\n prior to day 1.\r\n\r\n - Prednisone dose ≤ 20 mg daily (or other equivalent oral corticosteroid) with stable\r\n dose ≥ 2 weeks prior to day 1.\r\n\r\n - Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR,\r\n QRS, QT and QTc interval) at screening and baseline based on opinion of the\r\n investigator.\r\n\r\n - Immunizations (tetanus, diphtheria, pertussis [Td/Tdap]), seasonal influenza (during\r\n flu season), and pneumococcal (polysaccharide) vaccinations] up to date per local\r\n standards as determined by the investigator.\r\n\r\n Exclusion Criteria:\r\n\r\n Participants are excluded from the study if any of the following criteria apply.\r\n\r\n Disease Related\r\n\r\n - History of lupus nephritis requiring induction therapy and/or lupus cerebritis ≤ 1 year\r\n prior to screening.\r\n\r\n Other Medical Conditions\r\n\r\n - Diagnosis of inflammatory joint or skin disease other than SLE which would interfere\r\n with SLE disease assessment based on investigator judgement.\r\n\r\n - Diagnosis of fibromyalgia which would interfere with SLE assessment according to the\r\n investigator.\r\n\r\n - Prosthetic joint infection within 3 years of screening or native joint infection\r\n within 1 year prior to screening.\r\n\r\n - Active infection (including chronic or localized infections) for which anti-infectives\r\n were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined\r\n as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to\r\n day 1.\r\n\r\n - Known history of active tuberculosis.\r\n\r\n - Positive test for tuberculosis during screening defined as either:\r\n\r\n - positive purified protein derivative (PPD) (≥ 5 mm of induration at 48 to 72\r\n hours after test is placed) OR positive Quantiferon test\r\n\r\n - a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with\r\n a negative Quantiferon test and negative chest X-ray.\r\n\r\n - a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination)\r\n or a positive or indeterminate Quantiferon test are allowed if they have ALL of\r\n the following at screening:\r\n\r\n - no symptoms per tuberculosis worksheet provided by Amgen\r\n\r\n - documented history of a completed course of adequate prophylaxis (completed treatment\r\n for latent tuberculosis per local standard of care prior to the start of\r\n investigational product)\r\n\r\n - no known exposure to a case of active tuberculosis after most recent prophylaxis\r\n\r\n - negative chest X-ray.\r\n\r\n - Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by\r\n hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus\r\n RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by\r\n hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B\r\n vaccination without history of hepatitis B is allowed.\r\n\r\n - Positive for Human Immunodeficiency Virus (HIV) at screening, or known to be HIV\r\n positive.\r\n\r\n - Presence of one or more significant concurrent medical conditions per investigator\r\n judgment, including but not limited to the following:\r\n\r\n - poorly controlled diabetes or hypertension\r\n\r\n - chronic kidney disease stage IIIb, IV, or V\r\n\r\n - symptomatic heart failure (New York Heart Association class II, III, or IV)\r\n\r\n - myocardial infarction or unstable angina pectoris within the past 12 months prior\r\n to randomization\r\n\r\n - severe chronic pulmonary disease (eg, requiring oxygen therapy)\r\n\r\n - multiple sclerosis or any other demyelinating disease\r\n\r\n - major chronic inflammatory disease or connective tissue disease other than SLE\r\n (eg, RA).\r\n\r\n - Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in\r\n situ within 5 years of screening.\r\n\r\n - Participants with a urine test positive for illicit drugs or alcohol at the screening\r\n visit. Prescription medications detected by the drug test are allowed if they are\r\n being taken under the direction of a physician.\r\n\r\n - History of alcohol or substance abuse within 6 months of screening.\r\n\r\n - Current smoker, and/or use of any nicotine or tobacco containing products within the\r\n last 6 months prior to day 1. These types of products include but are not limited to:\r\n snuff, chewing tobacco, cigars, cigarettes, electronic cigarettes, pipes, or nicotine\r\n patches.\r\n\r\n - Participant unwilling to limit alcohol consumption to ≤ 1 drink of alcohol per day and\r\n ≤3 drinks per week for the duration of the study, where a drink is equivalent to 12\r\n ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces\r\n of 80 proof distilled spirits.\r\n\r\n Prior/Concomitant Therapy\r\n\r\n - Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen\r\n mustard, or any other alkylating agent ≤ 6 months prior to day 1 OR oral calcineurin\r\n inhibitors (eg, cyclosporine, tacrolimus, sirolimus) ≤ 4 weeks prior to day 1.\r\n\r\n - Current or previous treatment for SLE with a biologic agent as follows: rituximab < 6\r\n months prior to day 1, belimumab < 3 months prior to day 1, abatacept < 8 weeks prior\r\n to day 1.\r\n\r\n - Currently receiving or had treatment with T cell depleting agents (eg, antithymocyte\r\n globulin, Campath) or recombinant IL-2 (eg, Proleukin).\r\n\r\n - Participants who have received intra-articular or systemic corticosteroid injections\r\n within 4 weeks prior to day 1 or topical steroids within 2 weeks prior to day 1.\r\n\r\n - Administration of herbal supplements, vitamins, or nutritional supplements within 30\r\n days prior to the first dose of investigational product, and continuing use, if\r\n applicable, will be reviewed by the Investigator and the Amgen Medical Monitor to\r\n determine acceptability. Written documentation of this review and Amgen acknowledgment\r\n is required for participant participation.\r\n\r\n Prior/Concurrent Clinical Study Experience\r\n\r\n - Currently receiving treatment in another investigational device or drug study, or less\r\n than 30 days at day 1 since ending treatment on another investigational device or drug\r\n study(ies). Other investigational procedures while participating in this study are\r\n excluded.\r\n\r\n - Participant previously enrolled in this study may not be re-enrolled unless they\r\n fulfill the following criteria:\r\n\r\n - Have completed the study previously without any adverse events deemed related to\r\n study drug.\r\n\r\n - Have received the last dose of Efavaleukin Alfa/placebo > 6 months prior to the\r\n screening visit.\r\n\r\n - Must not have tested positive for neutralizing antibodies against Efavaleukin\r\n Alfa at any time.\r\n\r\n Diagnostic Assessments\r\n\r\n - Presence of laboratory abnormalities at screening including the following:\r\n\r\n - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5x upper\r\n limit of normal (ULN)\r\n\r\n - Serum total bilirubin (TBL) ≥ 1.5 mg/dL (≥ 26 μmol/L)\r\n\r\n - Hemoglobin < 9.0 g/dL(< 90 g/L)\r\n\r\n - Platelet count < 100,000/mm^3 (100 x 10^9/L)\r\n\r\n - White blood cell count < 2,000 cells/mm^3 (2.0 x 10^9/L)\r\n\r\n - Absolute neutrophil count (ANC) < 1,000/mm^3 (1.0 x 10^9/L)\r\n\r\n - Calculated glomerular filtration rate of ≤ 50 mL/min/1.73 m^2 using the\r\n Modification of Diet in Renal Disease (MDRD) formula.\r\n\r\n - Any other laboratory abnormality, which, in the opinion of the investigator, poses a\r\n safety risk, will prevent the participant from completing the study, will interfere\r\n with the interpretation of the study results, or might cause the study to be\r\n detrimental to the participant.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Efavaleukin Alfa', 'Placebo']\n- **Description:** ['Efavaleukin Alfa will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.', 'The placebo will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02256631
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nEvaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants\n\n**Trial Summary:** \n\n\n The purpose of this study was to assess the safety and pharmacokinetics (PK) of three\r\n monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at\r\n increased risk of mother-to-child HIV transmission.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** HIV Infections\n\n**Condition Keywords:** HIV Infections\n\n**ICD Code:** [\"['Z21']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 0 Days\n- **Maximum Age:** 5 Days\n- **Criteria:** \n Maternal Inclusion Criteria:\r\n\r\n - HIV infection\r\n\r\n - Greater than or equal to 18 years of age\r\n\r\n - Able and willing to provide signed informed consent for herself and her infant\r\n\r\n Maternal Exclusion Criteria:\r\n\r\n - Prior participation in any HIV-1 vaccine trial\r\n\r\n - Receipt of any other active or passive HIV immunotherapy or investigational product\r\n during this pregnancy. (Note that administration of Food and Drug Administration\r\n [FDA]-approved antiretroviral (ARV) drugs when used to treat disease or prevent\r\n mother-to-child transmission were not considered investigational.)\r\n\r\n - Documented or suspected serious medical illness or immediate life-threatening\r\n condition (other than HIV infection) in the mother that may have interfered with the\r\n ability to complete study requirements, as judged by the examining clinician\r\n\r\n Infant Inclusion Criteria:\r\n\r\n - Born to an HIV-1-infected woman who met all maternal inclusion/exclusion criteria\r\n listed above\r\n\r\n - Gestational age, by best obstetrical, ultrasound, or infant exam, greater than or\r\n equal to 36 weeks\r\n\r\n - Birth weight greater than or equal to 2.0 kg\r\n\r\n - Allowable infant age at the time of enrollment was dependent on the Dose Group and\r\n Cohort:\r\n\r\n - Dose Groups 1, 2, 4 and 5 (Cohort 1): Less than 72 hours of age, and anticipated\r\n availability to receive VRC immunization at less than 72 hours after birth.\r\n\r\n - Dose Groups 3, 4 and 5 (Cohort 2): Less than or equal to 5 days of age, and\r\n anticipated availability to receive VRC immunization no more than 5 days after\r\n birth.\r\n\r\n - At increased risk of HIV acquisition defined as documentation of one or more of the\r\n following risk factors:\r\n\r\n - Dose Groups 1, 2, 4 and 5 (Cohort 1), only:\r\n\r\n - Mother received no antiretroviral therapy (ART) during pregnancy or mother began\r\n or reinitiated ART (after an interruption of greater than 14 days), during the\r\n third trimester of pregnancy; or\r\n\r\n - Mother with any detectable viral replication (HIV RNA above the limit of\r\n detection) at last measurement prior to delivery determined within 30 days of\r\n delivery; or\r\n\r\n - Prolonged rupture of membranes (greater than 12 hours); or\r\n\r\n - Mother with documented 2-class resistant HIV infection, which may have included\r\n historical documentation of lack of response\r\n\r\n - Women who had a documented history of virologic failure while on\r\n non-nucleoside reverse transcriptase inhibitors (NNRTIs) but who had no\r\n resistance testing at the time of viral failure were considered to have\r\n NNRTI-documented resistance.\r\n\r\n - Dose Groups 3, 4 and 5 (Cohort 2), only (African sites):\r\n\r\n - Mother intended to breastfeed\r\n\r\n Infant Exclusion Criteria:\r\n\r\n - Receipt of any other active or passive HIV immunotherapy or investigational product\r\n other than the study vaccine (Note: Infant prophylaxis with any licensed ARV drugs\r\n clinically prescribed to prevent mother-to-child HIV transmission were not considered\r\n investigational.)\r\n\r\n - Receipt of or anticipated need for blood products, immunoglobulin, or\r\n immunosuppressive therapy. This included infants who required hepatitis B\r\n immunoglobulin (HBIG) but did not require exclusion of infants who received hepatitis\r\n B vaccine in the newborn period.\r\n\r\n - Documented or suspected serious medical illness, serious congenital anomaly, or\r\n immediate life-threatening condition in the infant that may have interfered with the\r\n ability to complete study requirements, as judged by the examining clinician\r\n\r\n - Any requirement for supplemental oxygen beyond 24 hours of life or requiring\r\n supplemental oxygen at the time of the VRC01, VRC01LS, or VRC07-523LS dose\r\n\r\n - Baseline laboratory results:\r\n\r\n - Hemoglobin less than 12.0 g/dL\r\n\r\n - Platelet count less than 100,000 cells/mm^3\r\n\r\n - Absolute neutrophil count: for infants less than or equal to 24 hours old, less\r\n than 4,000 cells/mm^3; for infants greater than 24 hours old, less than 1,250\r\n cells/mm^3\r\n\r\n - Serum glutamic pyruvic transaminase (SGPT) greater than or equal to 1.25 times\r\n upper limit of age adjusted normal\r\n\r\n - Dose Groups 1, 2, 4 and 5 (Cohort 1), only: Infant was breastfeeding at time of\r\n enrollment or mother had indicated an intention to initiate breastfeeding. Note: if a\r\n child was breastfed prior to known maternal diagnosis (in the case of a woman\r\n diagnosed in the intrapartum period), the child was still eligible as long as\r\n breastfeeding was stopped by the time the child was enrolled and there was no plan to\r\n resume breast milk feeding.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['VRC01', 'VRC01LS', 'VRC07-523LS']\n- **Description:** ['Administered by subcutaneous injection in the thigh', 'Administered by subcutaneous injection in the thigh', 'Administered by subcutaneous injection in the thigh']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT01894776
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc\n\n**Trial Summary:** \n\n\n Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to\r\n characterize the pharmacokinetic properties of maraviroc alone and when administered with\r\n rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to\r\n the literature.\r\n \n\n**Trial Keywords:** healthy volunteers\n\n**Phase:** Phase 1\n\n**Condition:** ['HIV Infection', 'HIV-1 Infection', 'Mycobacterium Avium Complex (MAC)']\n\n**Condition Keywords:** ['Infections', 'Communicable Diseases', 'Mycobacterium avium-intracellulare Infection']\n\n**ICD Code:** [\"['Z21']\", \"['B20', 'Z71.7', 'Z29.81', 'O98.72', 'Z21', 'O98.73', 'R75']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 65 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Able and willing to sign informed consent prior to any study-related activities.\r\n\r\n - Male or female participants between 18 and 65 years of age inclusive.\r\n\r\n - Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).\r\n\r\n - Healthy, i.e. not suffering from an acute or chronic illness and not using\r\n medications.\r\n\r\n - Acceptable medical history, physical examination, and 12-lead ECG at screening.\r\n\r\n - Acceptable laboratory values that indicate adequate baseline organ function at\r\n screening visit.\r\n\r\n - Willing to stop using any herbal or natural health products for 2 weeks prior to and\r\n during the study including: Grapefruit, grapefruit juice, St. John's Wort.\r\n\r\n - Willingness to abstain from alcohol use for 3 days prior to and during the study.\r\n\r\n - Participant must practice a reliable method of birth control while they are\r\n participating in the study; for instance an intrauterine device (IUD), condom with\r\n spermicidal gel or foam, diaphragm with spermicidal gel or foam, vasectomy, tubal\r\n ligation, hysterectomy or abstinence or female must be post menopausal for at least\r\n one year.\r\n\r\n Exclusion Criteria:\r\n\r\n - Have serological evidence of exposure to HIV\r\n\r\n - Female patients of childbearing potential who has a positive urine pregnancy test at\r\n screening\r\n\r\n - Participants not willing to use a reliable method of barrier contraception during the\r\n study.\r\n\r\n - Is breastfeeding.\r\n\r\n - Inability to adhere to protocol.\r\n\r\n - Use of any medications (2 weeks prior to or during the study) other than occasional\r\n use of acetaminophen.\r\n\r\n - Participants taking oral contraceptive medications.\r\n\r\n - Any condition possibly affecting drug absorption (eg, gastrectomy).\r\n\r\n - Patients may be excluded from the study for other reasons, at the investigator's\r\n discretion.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Rifabutin', 'Maraviroc']\n- **Description:** ['Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days', 'Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days']\n- **Mesh Terms:** ['Maraviroc', 'Rifabutin']\nSMILES: ['CO[C@H]1\\\\C=C\\\\O[C@@]2(C)OC3=C(C2=O)C2=C(C(O)=C3C)C(=O)C(NC(=O)\\\\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)=C1NC3(CCN(CC3)CC(C)C)N=C21', 'CC(C)C1=NN=C(C)N1[C@H]1C[C@@H]2CC[C@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)C1=CC=CC=C1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02529072
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nNivolumab With DC Vaccines for Recurrent Brain Tumors\n\n**Trial Summary:** \n\n\n Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will\r\n receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab\r\n alone and with DC vaccine therapy until surgical resection. During surgical resection blood\r\n and tumor samples will be assessed and compared. Following surgery, both groups will continue\r\n to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['Malignant Glioma', 'Astrocytoma', 'Glioblastoma']\n\n**Condition Keywords:** ['Glioblastoma', 'Astrocytoma', 'Glioma']\n\n**ICD Code:** [\"['R18.0', 'C17.3', 'G21.0', 'J91.0', 'C05.2', 'C10.0', 'C16.0']\", 'None', 'None']\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** All\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 80 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Age 18-80 years of age\r\n\r\n - First or second recurrence of MG (WHO Grade III or IV glioma or astrocytoma) in\r\n surgically accessible areas with prior histologic diagnosis of MG\r\n\r\n - Bevacizumab-naïve - no prior exposure to Bevacizumab\r\n\r\n - Karnofsky Performance Status (KPS) of ≥ 70%\r\n\r\n - Radiation Therapy (RT) with ≥ 45 Gray (Gy) tumor dose, completed ≥ 8 weeks prior to\r\n study entry\r\n\r\n - Laboratory values must meet the following criteria:\r\n\r\n 1. White Blood Count (WBC) ≥ 2000/microliters (uL)\r\n\r\n 2. Neutrophils ≥ 1500/uL\r\n\r\n 3. Platelets ≥ 100x103/uL\r\n\r\n 4. Hemoglobin ≥ 9.0 g/dL\r\n\r\n 5. Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance\r\n (CrCl)≥ 40 mL/min (using the Cockcroft-Gault formula) c. Female CrCl = (140 - age\r\n in years) x weight in kg x 0.85 /72 x serum creatinine in mg/dL d. Male CrCl =\r\n (140 - age in years) x weight in kg x 1.00/72 x serum creatinine in mg/dL\r\n\r\n 6. Aspartate Aminotransferase (AST) ≤ 3x ULN\r\n\r\n 7. Alanine Aminotransferase (ALT) ≤ 3x ULN\r\n\r\n 8. Bilirubin≤ 1.5x ULN (except subjects with Gilbert Syndrome, who can have total\r\n bilirubin < 3.0 mg/dL)\r\n\r\n 9. Subjects must have resting baseline O2 saturation by pulse oximetry of ≥ 92% at\r\n rest.\r\n\r\n - Patients of child bearing potential or with partners of child-bearing potential must\r\n practice recommended contraceptive methods to prevent pregnancy during treatment and\r\n for 5 months after the last dose of nivolumab for women, 7 months after the last dose\r\n of nivolumab for men, and for 6 months after the last dose of bevacizumab for subjects\r\n receiving bevacizumab.\r\n\r\n Exclusion Criteria:\r\n\r\n - Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor\r\n dissemination (subependymal or leptomeningeal)\r\n\r\n - Clinically significant increased intracranial pressure (e.g., impending herniation),\r\n uncontrolled seizures, or requirement for immediate palliative treatment\r\n\r\n - Pregnant or need to breast feed during the study period (Negative human chorionic\r\n gonadotropin (β-HCG) test required), or unable to maintain use of contraception while\r\n on study and for 31 weeks after the last dose of nivolumab\r\n\r\n - Active infection requiring treatment or an unexplained febrile (> 101.5o F) illness\r\n\r\n - Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus\r\n infection, Hepatitis B or Hepatitis C\r\n\r\n - Known allergy or hypersensitivity to tetanus, or any other tetanus or diphtheria\r\n toxoid-containing vaccine, or any component of this vaccine (i.e., aluminum phosphate,\r\n formaldehyde)\r\n\r\n - Known severe (Grade 3 or 4) infusion-related allergy or hypersensitivity to any\r\n monoclonal antibody\r\n\r\n - Previous radiation therapy with anything other than standard radiation therapy (such\r\n as previous stereotactic radiosurgery) or previous treatment with an immune checkpoint\r\n inhibitor (i.e., nivolumab, pembrolizumab, ipilimumab)\r\n\r\n - Unstable or severe intercurrent medical conditions such as severe heart (New York\r\n Association Class 3 or 4) or lung (FEV1 < 50%) disease, uncontrolled diabetes mellitus\r\n\r\n - Corticosteroid use > 4 mg/day at time of consent\r\n\r\n - Prior inguinal lymph node dissection.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['nivolumab', 'DC']\n- **Description:** ['Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cluster of differentiation 279 cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes. Binding of PD-1 to its ligands, programmed death-ligands 1 and 2, results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T cell responses to both foreign antigens as well as self-antigens. Nivolumab is expressed in Chinese hamster ovary cells and is produced using standard mammalian cell cultivation and chromatographic purification technologies. The clinical study product is a sterile solution for parenteral administration.', \"DCs are potent immunostimulatory cells that continuously sample the antigenic environment of the host and specifically activate cluster of differentiation 4 positive (CD4+) and cluster of differentiation 8 positive (CD8+) T-cells and B-cells. They are at the crossroads of many of the elegant networks of the immune system, and DCs represent the most promising contemporary biologic entity for realizing the promise of immunotherapy. Potent immune responses and encouraging clinical results have been seen in Phase I and II human clinical trials in systemic cancers. Numerous animal studies and the investigator's institution's humans studies have demonstrated potent antitumor responses using DC-based immunotherapy against MGs.\"]\n- **Mesh Terms:** ['Nivolumab', 'Vaccines']\nSMILES: ['NC1=NC(=O)N(C=C1)[C@H]1C[C@H](O)[C@@H](CO)O1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
|
NCT02246478
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Study of TAS-205 for Duchenne Muscular Dystrophy\n\n**Trial Summary:** \n\n\n The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in\r\n patients with Duchenne Muscular Dystrophy.\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** Duchenne Muscular Dystrophy\n\n**Condition Keywords:** ['Muscular Dystrophies', 'Muscular Dystrophy, Duchenne']\n\n**ICD Code:** [\"['G71.01']\"]\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** No\n- **Gender:** Male\n- **Minimum Age:** 5 Years\n- **Maximum Age:** 15 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Able to give an informed consent. If applicable, able to give an informed assent.\r\n\r\n - Male and >= 5 years and < 16 years of age.\r\n\r\n - Bodyweight of >= 15.0 kg and < 75.0 kg.\r\n\r\n - Phenotypic evidence of DMD.\r\n\r\n - Able to take tablets.\r\n\r\n - If taking oral glucocorticosteroids no significant change in total daily dosage or\r\n dosing regimen after enrollment.\r\n\r\n - Confirmed the urinary PD marker over its criteria.\r\n\r\n - Able to follow the study protocol.\r\n\r\n Exclusion Criteria:\r\n\r\n - Current diagnosis or history of any drug allergy.\r\n\r\n - A forced vital capacity (FVC) < 50% of predicted value.\r\n\r\n - A left ventricular ejection fraction (EF) < 50% or fractional shortening (FS) < 25%\r\n based on echocardiogram (ECHO).\r\n\r\n - Ongoing immunosuppressive therapy (other than corticosteroids).\r\n\r\n - With severe disease such as hepatic disease, kidney disease and others.\r\n\r\n - With any systemic allergic disease or any chronic inflammatory disease.\r\n\r\n - Treated with any other investigational agents within 90 days.\r\n\r\n - Positive reaction in hepatitis B surface antigen (HbsAg), hepatitis C antibody test\r\n (HCV), or human immunodeficiency virus (HIV) test.\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['TAS-205', 'Placebo']\n- **Description:** ['Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals\\r\\nMultiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals', 'Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals\\r\\nMultiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals']\n- **Mesh Terms:** None\nSMILES: None\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT04970342
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nValidation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim\n\n**Trial Summary:** \n\n\n Subjects will participate in a 4-visit study protocol at the National Advanced Driving\r\n Simulator, part of the University of Iowa, in which they will be asked to complete assorted\r\n questionnaires, computerized cognitive tasks, and a simulator drive. Subjects will be\r\n administered 0.75 mg alprazolam (Xanax) or placebo and 500 mg vaporized cannabis (6.18% THC /\r\n <0.025% CBD) or placebo (0% THC / 0% CBD).\r\n\r\n The primary objective of this study is to validate the Drug Impaired Driving Scenario (DIDS)\r\n using the CRCDS-2 driving simulator by assessing the acute effects of cannabis relative to\r\n placebo on simulated driving performance. Assay sensitivity will be demonstrated by the\r\n significant effect of 0.75 mg alprazolam (active comparator) on driving and cognitive\r\n endpoints.\r\n \n\n**Trial Keywords:** ['Driving', 'Cannabis', 'Xanax', 'Marijuana', 'Alprazolam', 'Driving Impairment', 'Substance Use', 'SDLP', 'CogScreen', 'CRCDS']\n\n**Phase:** Phase 1\n\n**Condition:** ['Driving Behavior', 'Driving Under the Influence']\n\n**Condition Keywords:** None\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** All\n- **Minimum Age:** 19 Years\n- **Maximum Age:** 45 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Understands and provides written informed consent prior to the initiation of any\r\n protocol-specific procedures.\r\n\r\n - Able to comprehend and willing to comply with the requirements of the protocol.\r\n\r\n - Healthy male or female adult, 19 to 45 years of age, inclusive, at Screening.\r\n\r\n - Regular sleep pattern (usual bedtime between 21:00 and 00:00).\r\n\r\n - Score <10 on Epworth Sleepiness Scale at Screening.\r\n\r\n - Able to reliably perform study assessments at Screening (On practice scenario, SDLP no\r\n higher than 1 standard deviation greater than the mean for normal healthy adults\r\n completing the practice scenario and subject has 7 or more correct hits on the Divided\r\n Attention task; CogScreen SDC Correct no less than 1 standard deviation below the mean\r\n for healthy adults); demonstrates the ability to understand task instructions at\r\n Screening; and is physically (e.g., adequate manual dexterity, vision, and hearing)\r\n and cognitively capable of performing study tasks at Screening.\r\n\r\n - Possesses (and is willing to provide) a valid driver's license and is an active\r\n driver.\r\n\r\n - Determined to be (by self-report) an active cannabis user with use of at least once\r\n per month over the preceding 90 days.\r\n\r\n - Willing to abstain from cannabis use (other than study drug) beginning at the end of\r\n Screening until discharge from NADS on Day 2 of Treatment Period 3.\r\n\r\n - Female subjects must meet one of the following criteria: 1) If of childbearing\r\n potential, female subjects agree to use two contraceptive regimens or remain abstinent\r\n during the study; or 2) if of non-childbearing potential, female subjects should be\r\n surgically sterile or in a menopausal state.\r\n\r\n Exclusion Criteria:\r\n\r\n - A significant history and/or presence of hepatic, renal, cardiovascular, pulmonary,\r\n neurological, psychiatric, gastrointestinal, hematological, immunologic,\r\n ophthalmologic, metabolic, or oncological disease, or any other medical issue that\r\n would, in the opinion of the Investigator, present undue risk for the subject in the\r\n study.\r\n\r\n - A history of suicidal behavior within 24 months of Screening, has answered YES to\r\n questions 3, 4, or 5 on the C-SSRS at Screening or at any clinic admission, or is\r\n currently at risk of suicide in the opinion of an Investigator.\r\n\r\n - A recent history (within 6 months prior to Screening) of substance use disorder\r\n (including alcohol) (as judged by the Investigator) or regularly consumes >2 alcoholic\r\n drinks/day during the last 3 months prior to Screening (1 alcoholic drink is\r\n approximately equivalent to: beer [284 mL], wine [125 mL/4 ounces], or distilled\r\n spirits [25 mL/1 ounce]). Subjects who consume 3 drinks per day but less than 14\r\n drinks per week may be enrolled at the discretion of the Investigator.\r\n\r\n - Demonstrates simulator sickness questionnaire scores which are indicative of simulator\r\n sickness as defined in the driving simulation operations manual.\r\n\r\n - Regularly consumes excessive amounts of caffeine, defined as greater than 6 servings\r\n of coffee, tea, cola, or other caffeinated beverages per day.\r\n\r\n - Smokes more than 10 cigarettes or e-cigarettes, or 3 cigars or pipes per day, or is\r\n unable to refrain from smoking during study visits.\r\n\r\n - Has been exposed to an investigational drug or device within the 30 days, or 5 half\r\n lives (if known), whichever is longer, prior to Screening.\r\n\r\n - Has used a prescription or over-the-counter medication known to cause sedation within\r\n 7 days prior to Admission for Period 1 and is unwilling or unable to refrain from\r\n sedating medication use during study participation.\r\n\r\n - Has used any benzodiazepine, barbiturate, or GABAA modulator (e.g., eszopiclone,\r\n zopiclone, zaleplon, and zolpidem) within 28 days prior to Admission for Period 1 or\r\n is unwilling or unable to refrain from medication use during study participation.\r\n\r\n - Has a history of hepatitis B surface antigen, hepatitis C antibodies, or human\r\n immunodeficiency virus (HIV) antibodies 1 or 2.\r\n\r\n - Is pregnant or breastfeeding at Screening or any clinic admission or will attempt to\r\n become pregnant at any time during study participation.\r\n\r\n - Has a clinically significant abnormal finding on 6-lead electrocardiogram (ECG) at\r\n Screening or at any clinic admission. The ECG may be repeated once for confirmatory\r\n purposes if initial values obtained exceed the limits specified.\r\n\r\n - Has a positive urine test for drugs of abuse (other than tetrahydrocannabinol (THC))\r\n or Breath Alcohol Concentration (BrAC) > 0.0 at Screening or any admission.\r\n\r\n - Has any clinically significant abnormal physical examination finding at Screening or\r\n any clinic admission.\r\n\r\n - Participates in night shift work.\r\n\r\n - Has traveled across ≥1 time zone in the 2 weeks prior to Admission for Period 1 or is\r\n expected to travel across ≥1 time zone during the study.\r\n\r\n - Is investigative site personnel or their immediate families (spouse, parent, child, or\r\n sibling whether biological or legally adopted).\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['Placebo (Lactose) Capsule', '0.75 mg Alprazolam Capsule', 'Cannabis (6.18% THC / <0.025% CBD)', 'Cannabis (0%/ THC / 0% CBD)']\n- **Description:** ['Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose', 'Single dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose', 'Cannabis vapor is produced from 500 mg of dried plant material (6.18% THC / <0.025% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose on one of the three study visits.', 'Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.']\n- **Mesh Terms:** Alprazolam\nSMILES: ['CC1=NN=C2CN=C(C3=CC=CC=C3)C3=C(C=CC(Cl)=C3)N12']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
NCT02544217
|
[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial has severe adverse event risk. Your task is to evaluate the risk of severe adverse events based on the provided information, including the **Trial Title:**, **Trial Summary:**, **Trial Keywords:**, **Phase:**, **Condition:**, **Condition Keywords:**, **ICD Code:**, **Eligibility Criteria:**, **Interventions:**, and finally the **Study Design:**.\n**Trial Title:** \n\nA Dose-escalating Clinical Trial With KH176\n\n**Trial Summary:** \n\n\n Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders\r\n affecting both children and adults. KH176 is a novel chemical entity currently under\r\n development for the treatment of inherited mitochondrial diseases, including MELAS\r\n (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease\r\n and Leber's Hereditary Optic Neuropathy (LHON). KH176 is a potent intracellular redox\r\n modulating agent targeting the reactive oxygen species which are important in the\r\n pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a\r\n favourable safety profile in the pre-clinical testing, the safety, tolerability and\r\n pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in\r\n healthy male subjects in this trial\r\n \n\n**Trial Keywords:** None\n\n**Phase:** Phase 1\n\n**Condition:** ['MELAS', 'LHON', 'Leigh Syndrome', 'Mitochondrial Disease', 'Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation']\n\n**Condition Keywords:** ['Leigh Disease', 'Mitochondrial Diseases']\n\n**ICD Code:** None\n\n**Eligibility Criteria:** \n\n- **Healthy Volunteers:** Accepts Healthy Volunteers\n- **Gender:** Male\n- **Minimum Age:** 18 Years\n- **Maximum Age:** 55 Years\n- **Criteria:** \n Inclusion Criteria:\r\n\r\n - Healthy as assessed by medical history, physical examination, Vital Signs, Clinical\r\n Laboratory, ECG\r\n\r\n Exclusion Criteria:\r\n\r\n - Allergies,\r\n\r\n - Concomitant medication,\r\n\r\n - concomitant disease,\r\n\r\n - relevant surgery,\r\n\r\n - recent blood donation\r\n \n\n\n**Interventions:** \n\n- **Intervention Name:** ['KH176', 'placebo']\n- **Description:** None\n- **Mesh Terms:** 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid\nSMILES: ['CC1=C(O)C(C)=C2CC[C@](C)(OC2=C1C)C(=O)N[C@@H]1CCCNC1']\n\n\n**Study Design:** \n\n{{Study_Design}}\n\nBased on the above information, provide your judgement wether the Clinical Trial has severe adverse event risk. Please provide your judgement in short form, using \"Yes\" and \"No\".\n"
}
] |
[
{
"role": "assistant",
"content": "**Answer:** No\n"
}
] |
No
|
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