anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Risperidone
Trial phase: Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 608
Group description: Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
Eligibility criteria:
Inclusion Criteria:

Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria as specified by the protocol for at least 1 year before screening
Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
A total PANSS score between 60 and 120, inclusive, at screening and baseline; Body mass index (BMI) at the screening visit BMI at least 17 kg/m2
Female patients must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study as specified by the protocol. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hCG) pregnancy test result at screening.

Exclusion Criteria:

Patient unable to provide consent or involuntarily committed to psychiatric hospitalization; A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease including history of neuroleptic malignant syndrome; History of any severe pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water (applies to those patients requiring oral tolerability only)
Significant risk of suicidal or violent behavior, as clinically assessed by the investigator ; History of life-threatening allergic reaction to any drug; Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
Have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months before screening; History of any active malignancy within the previous 5 years, with the exception of basal cell carcinomas
Women who are pregnant or breast-feeding or are planning to become pregnant uring the study
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily

atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily
Eligibility criteria:
Inclusion Criteria:

Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve
Echocardiographic derived mean pressure gradient >10 mmHg and an aortic valve area of 0.9 to 1.7 cm2 by continuity equation.
Laboratory evidence of LDL-c>70 mg/dl within 12 months prior to recruitment.

Exclusion Criteria:

Left ventricular ejection fraction <50%
Valvular area of 0.9 cm2 and a mean gradient >30 mmHg
Rheumatic heart disease
>Moderate (2+) aortic insufficiency
Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other HMG-CoA Reductase Inhibitors (statins)
End-stage renal disease (ESRD)
History of thoracic radiation
Unable or unwilling to sign informed consent
Unable to unwilling to return for follow-up
Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or hematological disorders, vasculitis, or any other situation or medical condition that, in the investigator's opinion, would make survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study or produce a significant risk to the patient
Severe pulmonary hypertension (>55 mmHg)
Intervention: Ondansetron
Trial phase: Phase 2
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: Patients receiving Ondansetron 4mg IV
Eligibility criteria:
Inclusion Criteria:

Patients presenting to the ED with at least one of the following
Nausea
Vomiting documented in the ED

Exclusion Criteria:

Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or metaclopramide
Patients with missed last menstrual period
Pregnancy
Age < 18 years old
Treatment with antineoplastic agents within 7 days prior to randomization
Irritable bowel syndrome
Gastroparesis
Suspected gastrointestinal bleed
Suspected intestinal obstruction
Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease)
Traumatic brain injury upon admission to ED
Intracranial hemorrhage upon admission to ED
Patients unable to read, write or communicate in the English language
Patients leaving the ED against medical advice
Intervention: Fludeoxyglucose (18F)
Trial phase: Not Applicable
ATC code: V09IX04
SMILES: OCC1OC(O)C(F)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: 19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical.

18FDG (an FDA-approved radiopharmaceutical): Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
Eligibility criteria:
Inclusion Criteria:

known or high suspicion of cholecystitis
highly likely to undergo cholecystectomy
positive HIDA study
age >18 years old
provide written informed consent

Exclusion Criteria:

highly unlikely to proceed to surgery or biopsy
received an investigational drug within the past 30 days
pregnant or lactating
decline to provide written informed consent
Intervention: Baicalein
Trial phase: Phase 2
SMILES: O=c1cc(-c2ccccc2)oc2cc(O)c(O)c(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Chronic hepatitis C diagnosis, with abnormal liver function tests, positive serology for Hepatitis C antibody, positive viremia as indicated by PCR techniques.
Age 18 or over
There must be no plans to use interferon in the following 12 months due to EITHER: a specific contraindication to interferon therapy, including but not limited to:history of depression, or other psychiatric disease, history of autoimmune disease,psoriasis, rheumatoid arthritis, history of renal dysfunction, thyroid abnormalities, seizure disorder, depressed blood cell counts, history of asthma OR patient discontinuation of interferon-based therapy prematurely due to intolerable side effects with sustained active viremia OR patient refusal to take interferon
Patients must be able to understand and sign informed consent.
Female participants must agree to practice approved methods of birth control (if applicable).

Exclusion Criteria:

Coinfection with hepatitis B as defined by a positive Hepatitis B surface antigen (HBsAg) test.
Coinfection with HIV
Patients with alcohol intake >40g day
Patients with recent myocardial infarction or heart failure.
Concurrent use of Sho-saiko-to, or any of its constituent plants.
Concurrent use of interferon containing products.
Use of interferon-based treatment within the past 6 months.
Women who are pregnant, nursing, or have the potential to becoming pregnant, unless utilizing birth control. A negative pregnancy test must be documented during the screening period for women of childbearing potential.
History of malignancy, unless there is currently no evidence of disease and patient completed all surgery, radiotherapy and chemotherapy for that disease a minimum of two years previously
Concurrent life-threatening illness, for which the prognosis is poor.
Patients with diffusing capacity on pulmonary testing less than 50% of predicted will be excluded.
Patients with diffusing capacity on pulmonary testing less than 70% of predicted AND total lung capacity less than 80% of predicted will be excluded.
Intervention: Modafinil
Trial phase: Phase 1
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
Eligibility criteria:
Inclusion Criteria:

The diagnosis of tinnitus should be established by subject through exam and history performed by study physician in Ear, Nose and Throat (ENT) clinic.
Subjects will be age 20 or older.
Subjects should have tinnitus symptoms severe enough to seek medical attention.
Subjects will have been seen in the Hearing and Balance Center at University of Arkansas for Medical Sciences (UAMS).
Subjects will have had an audiogram.
Signed informed consent.
Women of childbearing potential must have a negative pregnancy test at screening and before being prescribed the study drug.
Peripheral neuropathy.
Hematologic (minimal values) at screening Absolute neutrophil count > 1,500 mm^3 Hemoglobin > 8.0 g/dl Platelet count > 100,000 mm^3

Exclusion Criteria:

Disease-Specific Concerns

Subjects who have locally advanced breast cancer with skin ulceration will be excluded from this study due to the risk of worsening ulcers and healing difficulties
Stage IV breast cancer
Inflammatory breast cancer

General Medical Concerns

Subjects with Echo Cardiogram performance status 2, 3, and 4 are not eligible for this study
Allergy to any component of the treatment regimen
Women who are breast feeding
Pregnancy or refusal to use effective contraception while participating in this study
Inability to comply with study and/or follow-up procedures
Subjects with secondary malignancy other than superficial skin cancer (squamous cell carcinoma and basal cell carcinoma of the skin) should be excluded

Bevacizumab-Specific Concerns

Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
Blood pressure of > 150/100 mmHg. Essential hypertension well controlled with anti hypertensive is not an exclusion criterion
Unstable angina
New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
History of myocardial infarction within 6 months
History of stroke within 6 months
Clinically significant peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
Presence of central nervous system or brain metastases
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
Pregnant (positive pregnancy test) or lactating
Urine protein: creatinine ratio >1.0 at screening
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
Serious, non-healing wound, ulcer, or bone fracture
Intervention: Azilsartan medoxomil
Trial phase: Phase 3
ATC code: C09CA09 | C09DA09
SMILES: CCOc1nc2cccc(C(=O)OCc3oc(=O)oc3C)c2n1Cc1ccc(-c2ccccc2-c2noc(=O)[nH]2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Eligibility criteria:
Inclusion Criteria:

The participant has essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg, inclusive at Day -1) and 24-hour mean systolic blood pressure 130-170 mm Hg, inclusive, at Day 1.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Clinical laboratory evaluations within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator.
Willing to discontinue current antihypertensive medication.

Exclusion Criteria:

Has sitting trough clinic diastolic blood pressure greater than 114 mm Hg.
Baseline 24 hour ambulatory blood pressure monitor reading of insufficient quality.
Hypersensitive to angiotensin II receptor blockers.
History of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
Clinically significant cardiac conduction defects.
Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Secondary hypertension of any etiology.
Non-compliant with study medication during run-in period.
Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL/min/1.73 m2) at Screening.
Known or suspected unilateral or bilateral renal artery stenosis.
History of drug abuse or a history of alcohol abuse within the past 2 years.
Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
Type 1 or poorly controlled type 2 diabetes mellitus.
Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
Hyperkalemia.
Upper arm circumference less than 24 cm or greater than 42 cm.
Works night (3rd) shift.
Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
Any other serious disease or condition at Screening (or Randomization) that would compromise participant safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol.
Randomized in a previous azilsartan medoxomil study.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
Intervention: Azilsartan medoxomil
Trial phase: Phase 3
ATC code: C09CA09 | C09DA09
SMILES: CCOc1nc2cccc(C(=O)OCc3oc(=O)oc3C)c2n1Cc1ccc(-c2ccccc2-c2noc(=O)[nH]2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Eligibility criteria:
Inclusion Criteria:

The participant has essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg, inclusive at Day -1) and 24-hour mean systolic blood pressure 130-170 mm Hg, inclusive, at Day 1.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Clinical laboratory evaluations within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator.
Willing to discontinue current antihypertensive medication.

Exclusion Criteria:

Has sitting trough clinic diastolic blood pressure greater than 114 mm Hg.
Baseline 24 hour ambulatory blood pressure monitor reading of insufficient quality.
Hypersensitive to angiotensin II receptor blockers.
History of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
Clinically significant cardiac conduction defects.
Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Secondary hypertension of any etiology.
Non-compliant with study medication during run-in period.
Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL/min/1.73 m2) at Screening.
Known or suspected unilateral or bilateral renal artery stenosis.
History of drug abuse or a history of alcohol abuse within the past 2 years.
Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
Type 1 or poorly controlled type 2 diabetes mellitus.
Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
Hyperkalemia.
Upper arm circumference less than 24 cm or greater than 42 cm.
Works night (3rd) shift.
Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
Any other serious disease or condition at Screening (or Randomization) that would compromise participant safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol.
Randomized in a previous azilsartan medoxomil study.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
Intervention: Azilsartan medoxomil
Trial phase: Phase 3
ATC code: C09CA09 | C09DA09
SMILES: CCOc1nc2cccc(C(=O)OCc3oc(=O)oc3C)c2n1Cc1ccc(-c2ccccc2-c2noc(=O)[nH]2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 188
Group description: Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Has essential hypertension and 24-hour mean systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 180 mm Hg.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study
Has clinical laboratory evaluations within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Is willing to discontinue current antihypertensive medications.

Exclusion Criteria:

Has sitting trough clinic diastolic blood pressure greater than 119 mm Hg.
Has a baseline 24 hour ambulatory blood pressure monitoring reading of insufficient quality.
The subject is hypersensitive to angiotensin II receptor blockers or calcium channel blockers.
Has a recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
Has clinically significant cardiac conduction defects.
Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Has secondary hypertension of any etiology
Is non-compliant with study medication during placebo run-in period.
Has severe renal dysfunction or disease.
Has known or suspected unilateral or bilateral renal artery stenosis.
Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
Has a previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
Has type 1 or poorly controlled type 2 diabetes mellitus.
Has hyperkalemia as defined by the central laboratory normal reference range,
Has an alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease or jaundice.
Has an upper arm circumference less than 24 cm or greater than 42 cm.
Works night (3rd) shift.
Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
Has any other serious disease or condition that would compromise subject safety or make it difficult to successfully manage and follow the subject according to the protocol.
Has been randomized in a previous TAK-491 study.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
Intervention: Temozolomide
Trial phase: Phase 2
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
Eligibility criteria:
Inclusion Criteria:

Stage III (unresectable) or Stage IV melanoma from a cutaneous or an unknown primary.
Histologic proof of melanoma reviewed and confirmed at MSKCC
Measurable disease (RECIST criteria)
No prior chemotherapy for melanoma. Prior interferon, interleukin-2 or vaccine therapy are allowed.
No other concurrent chemotherapy, immunotherapy, or radiotherapy
Karnofsky performance status ≥ 60
Adequate organ function defined as follows: ANC > 1500, Platelets > 100,000, creatinine < 2, Alkaline Phosphatase, AST and total bilirubin < 1.5x upper limit of normal. For patients with suspected Gilbert's syndrome bilirubin will not be a requirement.
Tumor tissue for MGMT promoter methylation analysis and/or IHC must be available. In most cases, this will be unstained slides from previously-obtained paraffin-embedded tumor material. If this is not available, patients must have an easily-accessable tumor for biopsy (e.g. skin or lymph node).

Exclusion Criteria:

History of CNS metastases unless brain metastases have been resected and the patient has been free from CNS recurrence for 6 months.
Uveal or mucosal melanoma primary
Frequent vomiting or medical conditions that could interfere with oral medication intake
Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
History of HIV infection even if on HAART
Immunosuppressive drugs
High dose vitamins and herbs
Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.