anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: RIFAMPIN
Trial phase: Phase 3
ATC code: J04AB02 | J04AM02 | J04AM05 | J04AM06 | J04AM07 | J04BA50 | J04BA51
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c(C=NN5CCN(C)CC5)c(O)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 180
Group description: rifampin (600 mg orally) given daily for 4 months
Eligibility criteria:
Inclusion Criteria:

The inclusion criteria for this study will be San Francisco Jail inmates, age 18 or older (the jail does not house juveniles) having evidence of M. tuberculosis infection by positive tuberculin skin test (a documented reactive tuberculin skin test to 0.1 mL containing 5 Tuberculin Units) who meet current national criteria for therapy for tuberculosis infection and can provide informed consent.

Exclusion Criteria:

Ineligible for either therapy regimen for any of the following reasons:

history of treatment-limiting reaction to isoniazid or rifamycins;
pregnancy or breast feeding;
active tuberculosis;
an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal;
bilirubin >2 times the upper limit of normal;
platelets <150 K/mm3;
taking protease inhibitors or nonnucleoside reverse transcriptase inhibitors (NNRTIs);
Unable to communicate in English or Spanish;
Unable or unwilling to provide informed consent;
Not in the routine level of jail security for any reason (housed in "special security" areas);
Any condition that, in the best judgment of the investigator, would pose a risk to the subject during the study.
Intervention: Cilostazol
Trial phase: Phase 4
ATC code: B01AC23
SMILES: O=C1CCc2cc(OCCCCc3nnnn3C3CCCCC3)ccc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 232
Group description: cilostazol 100mg twice a day plus placebo of clopidogrel
Eligibility criteria:
Inclusion Criteria:

Cerebral infarction within 2 weeks from the onset or TIA with corresponding acute ischemic brain lesions on MRI within 2 weeks from the onset
Age: more than 35 years of age
Patient with significant focal stenosis in the M1 segment of middle cerebral artery (MCA) or basilar artery (BA) with acute ischemic lesions on magnetic resonance imaging (MRI) within the vascular territory of the stenosed artery.

Exclusion Criteria:

Patients with any contraindications to the treatment with antiplatelet therapy
Patients with potential cardiac embolic source; prosthetic valve, atrial fibrillation, atrial flutter, left atrial/atrial appendage thrombus, sick sinus syndrome, left ventricular thrombus, dilated cardiomyopathy, akinetic or hypokinetic left ventricular segment, atrial myxoma, Infective endocarditis, mitral valve stenosis or prolapse, mitral annuls calcification, left atrial turbulence, nonbacterial endocarditis, congestive heart failure, recent myocardial infarction (within 4 weeks)
Patients with more than 50% stenosis in the parent artery of symptomatic stenosis
Bleeding diathesis
Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
Nonatherosclerotic vasculopathy; patients with clinical characteristics suggesting arterial dissection, moyamoya disease, Takayasu's arteritis, radiation associated angiopathy, and other vasculitis.
Severe stroke: NIH stroke scale : more than 16
Pregnant or lactating patients
Chronic user of NSAIDs
Thrombolytic therapy for the symptomatic stenosis
Symptomatic stenosis scheduled for angioplasty
Patients with pacemaker or any other contraindications to MRI
Intervention: Metformin
Trial phase: Phase 3
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Metformin Arm: initial dose of 500 mg BID was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID. At month 6 (visit 6), patients not achieving target received additional specified drug therapy: Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes patients
18 - 75 years old
Type 2 diabetes mellitus (DM) drug naïve or on submaximal oral monotherapy < 3 years

A1C criteria at screening:

7.1-10% for drug naïve patients after failure of diet control and life-style modification
7.1 - 9% on single therapy (e.g. not more 10 mg of Glyburide or 4 mg of Amaryl™ or 1000mg of Metformin) who will start after 2 weeks wash-out. During wash out the following will be done: i) diet and life style modification ii) Angiotensin converting enzyme inhibitor (ACE), aspirin (80 mg), and statin if appropriate
Signed informed consent

Exclusion Criteria:

Type 1 diabetes
Subjects currently treated with insulin
Subject treated for previous 3 month with any thiazolidinedione (TZD)
Evidence of clinically significant concomitant illnesses which are not controlled by medication and/or may limit participation in the study as judged by the investigator
Subjects who have hypersensitivity to any components of study drugs
Participation in a clinical trial and/or intake of an investigational drug within 30 days prior to screening.
Pregnant or nursing females
Females of childbearing potential who are not on adequate birth control
Liver enzymes (Alanine Aminotransferase (ALT) > 2.5 times upper limit of normal)
Renal impairment: serum creatinine ≥ 136umol/L (males) and ≥ 124 umol/L (females)
Congestive Heart Failure (CHF class III/IV)
Weight >160 kg
Intervention: Tenofovir Disoproxil Fumarate
Trial phase: Phase 2
SMILES: CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 186
Group description: Active arm: assigned to take TDF, 300mg po daily.
Eligibility criteria:
Inclusion Criteria:

Healthy biologic male (male at birth)
18-60 years of age
HIV-1 negative by licensed, commercially available, FDA-approved whole blood rapid enzyme immunoassay (EIA) at screening and enrollment
Reports any anal sex with a man in the last 12 months
Able to understand and pass comprehension assessment questionnaire
Able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Able to understand English
Adequate renal function: calculated creatinine clearance of at least 70 mL/min
Hepatic transaminases (AST and ALT) less than or equal to 2x upper limit of normal (ULN)
Total bilirubin less than or equal to 1.5 mg/dL
Absolute neutrophil count at least 1,500/mm3;
Platelets at least 100,000/mm3;
Hemoglobin at least 9.5 g/dL
Serum amylase less than or equal to 1.5 x ULN
Biochemical profile: within normal limits for serum phosphorus, potassium, sodium, and calcium.
Hepatitis B surface antigen negative
Normal urine dipstick or urinalysis (UA)

Exclusion Criteria:

Active untreated syphilis
Current uncontrolled hypertension (blood pressure > 160/100 mmHg)
Mutually monogamous for > one year with a known HIV antibody negative partner
History of chronic renal disease, known osteoporosis, osteomalacia, or osteopenia
Current or expected participation in other longitudinal HIV behavioral or biomedical research study
Current HIV antiretroviral use
Receiving or planning to receive on-going therapy with any nephrotoxic agents or experimental/investigational agents
Previous or expected requirements for the administration of immunosuppressive/ immunomodulatory therapy (e.g. chronic systemic steroids, interferon, interleukins, chemotherapy, radiation).
Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
Imminently life-threatening medical conditions (malignancy, immunosuppressive disease [e.g. lymphoma]), or other serious disease or conditions (e.g. cardiovascular, renal, diabetes) within the last 5 years or that are unstable and/or require chronic medication that would impede compliance with study requirements and complicate the interpretation of adverse events
Expected to be non-compliant with study visits or planning to move within 24 months to an area where the study will not be conducted
Any other clinical or social condition, prior therapy, occupation, or other responsibility, that, in the opinion of the investigator, would interfere with, or serve as a contraindication to study participation or compliance with the dosing requirements.
Intervention: Spironolactone
Trial phase: Phase 2 | Phase 3
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 147
Group description: Mineralocorticoid Receptor (MR) Antagonist group
Eligibility criteria:
Inclusion Criteria:

Undergoing elective valvular heart surgery, coronary artery bypass grafting
If female, must be postmenopausal for at least 1 year, status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and willing to undergo urine beta-hcg testing prior to drug treatment and throughout the study

Exclusion Criteria

History of AF other than remote paroxysmal AF
Ejection fraction less than 30%
Evidence of coagulopathy (INR greater than 1.7 without warfarin therapy)
Emergency surgery
History of ACE inhibitor-induced angioedema
Low blood pressure (systolic blood pressure less than 100 mmHg and evidence of hypoperfusion)
Hyperkalemia (potassium level greater than 5.0 milliequivalents (mEq)/L at study entry)
Impaired kidney function (serum creatinine level greater than 1.6 mg/dl)
Any underlying or acute disease requiring regular medication that could possibly cause complications or make implementation of the study or interpretation of the study results difficult
Inability to discontinue current ACE inhibitor, AT1 receptor antagonist, or aldosterone receptor antagonist therapy
History of alcohol or drug abuse
Treatment with any investigational drug in the month prior to study entry
Mental condition that makes it impossible to understand the nature, scope and possible consequences of the study
Inability to comply with the study procedures (e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study)
Pregnant or breastfeeding
Intervention: Methadone
Trial phase: Phase 2
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: methadone

Methadone: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg
Eligibility criteria:
Inclusion Criteria:

Retroperitoneal lymph node dissection
Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every 10 minutes
18 years of age or older
English-speaking
Give informed consent to participate in this study

Exclusion Criteria:

Known hypersensitivity to methadone or morphine
Patients with past or present history of substance abuse
Patients with a history of methadone treatment
Patients with a history of chronic pain requiring daily analgesic use for more than 3 months
Patients treated with opioids within one month from the scheduled surgery
Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation).
Neurologic or psychiatric disease sufficient, in the doctor's opinion, to compromise data collection
Intervention: Fluoxetine
Trial phase: Phase 2
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of current marijuana abuse or dependence, confirmed by SCID-SUD
DSM-IV diagnosis of current major depressive disorder, confirmed by the K-SADS
Marijuana use of at least two days within the week prior to enrollment
Demonstrated adequate levels of depressive symptoms within the week prior to enrollment

Exclusion Criteria:

DSM-IV diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia
Hypo or hyperthyroidism
Significant cardiac, neurological, or kidney impairment
Liver disease (SGOT, SGPT, or gamma-GTP greater than 3 times the normal level)
Use of antipsychotic or antidepressant medication in the month prior to enrollment
DSM-IV dependence on any substance except marijuana or nicotine; alcohol dependence, or history of drug use
History of significant medication side effects from any SSRI antidepressant
Pregnant
Unable to use adequate contraceptive methods for the duration of the study
Inability to read or understand English
Intervention: Haloperidol
Trial phase: Phase 3
ATC code: N05AD01
SMILES: O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
Eligibility criteria:
Inclusion Criteria:

Completed the short-term 041023 trial (NCT00156104)
Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
Sign a written informed consent for the 041513 trial.
Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator

Exclusion Criteria:

CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic)
Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation
Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial
Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.
Intervention: Technetium (99mTc) sestamibi
Trial phase: Phase 3
SMILES: [C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[Tc]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 329
Group description: Arm A children 4-11 years of age
Eligibility criteria:
Inclusion Criteria:

Males or females between 4 and 16
Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician.
Be able to exercise adequately to achieve 85% age predicted maximum heart rate

Exclusion Criteria:

Terminal illness where expected survival is < 6 months
Intervention: Technetium (99mTc) sestamibi
Trial phase: Phase 3
SMILES: [C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[Tc]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 116
Group description: Arm B adolescents 12-16 years of age
Eligibility criteria:
Inclusion Criteria:

Males or females between 4 and 16
Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician.
Be able to exercise adequately to achieve 85% age predicted maximum heart rate

Exclusion Criteria:

Terminal illness where expected survival is < 6 months
Intervention: Perflutren
Trial phase: Phase 4
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 400
Group description: Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.

Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Eligibility criteria:
Inclusion Criteria:

Peri or Post menopausal women either:

without symptoms but with risk factors for heart disease OR
experiencing atypical chest pain, OR
experiencing exertional dyspnea AND 2 or more risk factors for CAD
Must be able to perform an exercise stress test

Peri-or post-menopausal (including surgical menopause) based on history.

Post-menopausal is defined as females age 40-65 who self-report the absence of menstrual periods for at least 12 months.
Peri-menopausal is defined as females age 40-65 who self-report the absence or irregularity of menstrual periods for 6-12 months.
Surgical menopause is defined as females who have had a bilateral salpingo-oophorectomy with or without hysterectomy.

Exclusion Criteria:

Previous confirmed heart disease
Intervention: Rabeprazole
Trial phase: Phase 2
ATC code: A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03
SMILES: COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 103
Group description: Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
Eligibility criteria:
Key Inclusion Criteria:

Male or female patients, 18 to 65 years of age.
If female, not of childbearing potential by reason of surgery, radiation or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period, for example, intrauterine device (IUD), implant, double barrier method, or oral contraceptives for at least one cycle. Females of childbearing potential must have a negative urine pregnancy test before medication is dispensed.
Patients must report a minimum three-month history of GERD symptoms. GERD symptoms are defined as heartburn with or without regurgitation or other associated GERD symptoms.
Patients must have at least 4 days with heartburn per week in each of the 2 weeks prior to Screening.
Patients must have no esophagitis, with no proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to the endoscopy.

Key Exclusion Criteria:

Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and Investigator agree that the nature and severity of any abnormality is unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
Females must not be pregnant, lactating or have a positive urine eta human chorionic gonadotropin (B-hCG) laboratory result.
Patients with a history of allergy or sensitivity to proton pump inhibitors or to their inactive ingredients.
Patients with known gastric ulcer, duodenal ulcer, infectious or inflammatory conditions of the small or large intestine, malabsorption syndromes, obstruction, a history of gastrointestinal malignancy, or prior gastric or intestinal surgery (including vagotomy).
Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric stenosis.
Patients with a history of endoscopically-proven esophagitis any time in the past.
Patients who have taken proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to Screening endoscopy, or any of these medications within 7 days prior to the single-blind placebo run-in period.
Intervention: Rabeprazole
Trial phase: Phase 2
ATC code: A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03
SMILES: COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
Eligibility criteria:
Key Inclusion Criteria:

Male or female patients, 18 to 65 years of age.
If female, not of childbearing potential by reason of surgery, radiation or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period, for example, intrauterine device (IUD), implant, double barrier method, or oral contraceptives for at least one cycle. Females of childbearing potential must have a negative urine pregnancy test before medication is dispensed.
Patients must report a minimum three-month history of GERD symptoms. GERD symptoms are defined as heartburn with or without regurgitation or other associated GERD symptoms.
Patients must have at least 4 days with heartburn per week in each of the 2 weeks prior to Screening.
Patients must have no esophagitis, with no proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to the endoscopy.

Key Exclusion Criteria:

Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and Investigator agree that the nature and severity of any abnormality is unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
Females must not be pregnant, lactating or have a positive urine eta human chorionic gonadotropin (B-hCG) laboratory result.
Patients with a history of allergy or sensitivity to proton pump inhibitors or to their inactive ingredients.
Patients with known gastric ulcer, duodenal ulcer, infectious or inflammatory conditions of the small or large intestine, malabsorption syndromes, obstruction, a history of gastrointestinal malignancy, or prior gastric or intestinal surgery (including vagotomy).
Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric stenosis.
Patients with a history of endoscopically-proven esophagitis any time in the past.
Patients who have taken proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to Screening endoscopy, or any of these medications within 7 days prior to the single-blind placebo run-in period.