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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"
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] |
[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
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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"
}
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[
{
"role": "assistant",
"content": "**Answer:** Yes\n"
}
] |
Yes
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