anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fluoxetine
Trial phase: Phase 4
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 170
Group description: OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female inpatients or outpatients, 10-17 years of age, who have not reached their 18th birthday prior to screening. Patient must weigh at least 20 kilograms (kg) at screening.
Must meet diagnostic criteria for current major depressive episode of Bipolar I Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Version (DSM-IV-TR) and confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL)
Patients entering the study will also be scored by the Children's Depression Rating Scale-Revised (CDRS-R) (entry score of greater than or equal to 40) as well as the adolescent-structured Young Mania Rating Scale (YMRS) (entry score of less than or equal to 15 with YMRS Item 1 [elevated mood] score less than equal to 2).

Exclusion Criteria:

Patients will be excluded if they are, in the opinion of the investigator, actively suicidal
Have an acute, serious or unstable medical condition
Have clinically significant laboratory abnormalities
Have had one or more seizures of unclear etiology
Have a current or lifetime diagnosis of any of the following according to DSM-IV criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition, unless there is substantive reason to believe patient was misdiagnosed
Intervention: Ribavirin
Trial phase: Phase 4
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
Eligibility criteria:
Inclusion Criteria:

Newly acquired HCV infection of 6 months or less duration
Detectable HCV RNA at study entry
HIV infection, any CD4 count

Exclusion Criteria:

Pregnant or intent to become pregnant within 24 weeks of study completion
Uncontrolled depression
Other serious liver disease
Other safety parameters must be met
Intervention: Tadalafil
Trial phase: Phase 3
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 158
Group description: Tadalafil 5 mg taken by mouth once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.

Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.

Exclusion Criteria:

Currently receiving alpha-blocker therapy for the treatment of hypertension.
History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
Treated with nitrates for any cardiac conditions.
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have problems with kidneys, liver, or nervous system
Have uncontrolled diabetes
Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
Have had a stroke or a significant injury to brain or spinal cord.
Intervention: Fentanyl
Trial phase: Phase 2
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 17
Group description: patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.

Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
Eligibility criteria:
Inclusion Criteria:

Childrens with the diagnosis of tetralogy of fallot, ventricular septal defect and atrioventricular septal defect who are under one year of age.

Exclusion Criteria:

Patients who are having reoperation.
Patients with comorbidities, such as heart failure.
Patients receiving digoxin preoperatively.
Intervention: Fentanyl
Trial phase: Phase 2
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision

Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
Eligibility criteria:
Inclusion Criteria:

Childrens with the diagnosis of tetralogy of fallot, ventricular septal defect and atrioventricular septal defect who are under one year of age.

Exclusion Criteria:

Patients who are having reoperation.
Patients with comorbidities, such as heart failure.
Patients receiving digoxin preoperatively.
Intervention: Sunitinib Malate
Trial phase: Phase 2
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(C=C2C(=O)Nc3ccc(F)cc32)c1C.O=C(O)CC(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: therapeutic allogeneic lymphocytes: Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response

sunitinib malate: Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed renal cell carcinoma

Primary lesion or metastatic site demonstrating clear cell variant with < 25% of any other histology
Radiographically measurable disease by RECIST criteria
Initiated treatment with sunitinib malate ≤ 6 weeks ago
No radiographically detectable brain metastases by MRI or CT scan

HLA-partially matched related donor available, as determined by serologic and/or DNA typing

Appropriate HLA match (≥ 2/6 HLA A, B, DR match)

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Absolute neutrophil count > 1,500/mm³
Platelet count > 100,000/mm³
Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
AST ≤ 3.0 times ULN
Calculated creatinine clearance ≥ 40 mL/min
Cardiac ejection fraction ≥ 50%
QTc interval < 500 msec by EKG
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No known HIV positivity

None of the following within the past 6 months:

Myocardial infarction
Severe/unstable angina
Coronary/peripheral artery bypass graft
Symptomatic congestive heart failure
Cerebrovascular accident or transient ischemic attack
Pulmonary embolism
No ongoing ventricular cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0
No history of serious ventricular arrhythmia (e.g., ventricular tachycardia > 3 beats in a row)
No ongoing atrial fibrillation
No other malignancies within the past 3 years, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast
No other concurrent serious illness

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior systemic therapy for metastatic renal cell carcinoma
No prior immunotherapy
No prior VEGF-targeted or mTOR-targeted therapies
No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), St. John's wort, ketoconazole, dexamethasone, dysrhythmic drugs (e.g., terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice
No other concurrent investigational anticancer agents
Intervention: AZD2066
Trial phase: Phase 2
SMILES: C[C@@H](Oc1nnc(-c2ccncc2)n1C)c1cc(-c2cccc(Cl)c2)on1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Clinical diagnosis of painful diabetic neuropathy.
non-fertile females

Exclusion Criteria:

Other pain that may confound assessment of neuropathic pain.
Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
History of psychotic disorders among first degree relatives.
Intervention: Tadalafil
Trial phase: Phase 3
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 151
Group description: Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment

Exclusion Criteria:

Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
Clinical evidence of prostate cancer at initiation
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation
Intervention: Tadalafil
Trial phase: Phase 3
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 155
Group description: Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment

Exclusion Criteria:

Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
Clinical evidence of prostate cancer at initiation
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation
Intervention: Efavirenz
Trial phase: Phase 2
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.
Eligibility criteria:
Inclusion Criteria:

Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
No prior use of any approved or experimental anti-HIV drug
Normal electrocardiogram (ECG)
Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Cluster determinant 4 (CD4) cell count > 50 cells/µL
Serum amylase ≤ 1.5 x ULN
Normal thyroid-stimulating hormone
Negative serum pregnancy test (for females of childbearing potential only)
Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drugs
Life expectancy ≥ 1 year
Ability to understand and sign a written informed consent form

Exclusion Criteria:

New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s)
Hepatitis B surface antigen positive
Hepatitis C antibody positive
Participants experiencing cirrhosis
Participants experiencing ascites
Participants experiencing encephalopathy
Females who are breastfeeding
Positive serum pregnancy test (for females of childbearing potential)
Vaccinated within 90 days of study dosing
History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30
Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
Prolonged QTcF interval at screening
PR interval ≥ 200 msec or ≤ 120 msec on ECG at screening
QRS ≥ 120 msec on ECG at screening
Implanted defibrillator or pacemaker
Participants receiving ongoing therapy with any disallowed medications
Current alcohol or substance use judged to potentially interfere with participant study compliance
History of or ongoing malignancy (including untreated carcinoma in situ) other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
Participation in any other clinical trial without prior approval
Medications contraindicated for use with EFV, EVG, COBI, FTC, or TDF
Any known allergies to the excipients of Atripla or Stribild tablets
Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements
Intervention: Spironolactone
Trial phase: Phase 4
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: Accepts Healthy Volunteers
Participants at risk: 53
Group description: Experimental group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to experimental group will be initiated on 25mg of spironolactone. Serum potassium and creatinine levels will be drawn at baseline, weeks 1,4,5 and months 3,6,9, and 12. If at week 4, serum potassium is <5.5 mmol/L and serum creatinine-baseline creatinine is <0.5 mg/dl, the study drug will be increased to the target dose of 50mg once daily for 12 months of follow-up. If a subject experiences an increase in serum potassium or creatinine above these parameters at week 4, the study drug will be decreased in half from current dosage. If on 25mg daily, subject will be instructed to decrease to 25mg every other day. Subjects who experience hyperkalemia or increased creatinine levels on 25mg every other day will have the drug discontinued.
Eligibility criteria:
Inclusion Criteria:

Hypertrophic cardiomyopathy
Able to swallow pills
No prior septal reduction therapy
Negative serum or hCG pregnancy test

Exclusion Criteria:

Unable or unwilling to perform treadmill cardiopulmonary exercise test
Prior surgical myectomy or alcohol septal ablation
Known or suspected infiltrative or glycogen storage disease
Significant coronary artery disease, defined as atherosclerotic coronary artery narrowing >70% of the luminal diameter by coronary angiography
Severe obstructive pulmonary disease, defined as forced expiratory volume in 1 second (FEV1) <50% of predicted.
Prior intolerance or adverse reaction to aldosterone receptor antagonist.
History of hyper or hypoaldosteronism
Baseline serum potassium >5.0 mmol/L.
Calculated creatinine clearance <30 ml/min using Cockcroft-Gault formula.
Pregnant or breast feeding
Poorly controlled systemic hypertension, defined as systolic blood pressure ≥150 mmHg or diastolic pressure ≥100 mmHg, during 2 clinic visits.
Known conditions associated with elevated serum concentrations of PIIINP (e.g., chronic liver disease, diabetes mellitus, tumors, pulmonary fibrosis, bone and rheumatoid diseases, extensive wounds) or PINP (e.g., alcoholic liver disease, metabolic bone disease, thyroid disorders), including recent trauma (≤2 weeks) or surgery (≤6 months)
Taking drugs known to directly influence collagen metabolism including, amiodorone, ACE or angiotensin II inhibitors, aldosterone antagonists, statins, glucocorticoids and estrogens
Patients with ICDs/pacemakers will be recruited in the study, but will be excluded from the CMR component.
Intervention: Sodium sulfide
Trial phase: Phase 1
SMILES: [Na+].[Na+].[S-2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
Eligibility criteria:
Inclusion Criteria:

For normal subjects arm (CrCL > 80 ml/min): Healthy male and female subjects age 18 to 70 years of age inclusive. Pregnant women are excluded and women of child-bearing potential must agree to the use of medically reliable contraceptive methods for the duration of the study and for 30 days after study.

For renally impaired arm: Male and female - pregnant women are excluded and women of child-bearing potential must agree to the use of medically reliable contraceptive methods for the duration of the study and for 30 days after study. Subjects with mild, moderate and severe renal function aged between 18 to 70 years old

Body mass index (BMI) within the range of 18 to 40 kg/m2
Electrocardiogram (ECG) recording without clinically relevant abnormalities
Having had no febrile or infectious disease for at least seven days prior to dosing of study drug
Able to communicate well with the study staff and to understand and comply with the requirements of the study, understand and sign the written informed consent

Exclusion Criteria:

High risk patients who may need an urgent dialysis during clinical conduct portion of the study (from Day -1 until last PK sampling on Day 7)
All smokers.
More than moderate alcohol consumption (>35 g ethanol regularly or > 2 drinks per day )
Any history of alcohol or drug abuse
Any active physical or psychiatric disease, acute or chronic
Any clinically relevant history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis
Pregnant or nursing women
Blood donation within 30 days
Participation in any clinical study within 30 days prior to the treatment phase of this study
Lab values outside of reference range and clinically relevant liver function tests (AST, ALT, gamma-GT)
Positive tests for HIV antibodies, Hepatitis B-virus surface antigen (HBsAg), Anti-Hepatitis C-virus antibodies (Anti-HCV)
Intervention: Methadone
Trial phase: Phase 4
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: Methadone 10-60 mg per day in 2-4 divided doses for 6 months
Eligibility criteria:
Inclusion Criteria:

chronic back pain
opioid addiction
not successful with abstinence
at least 18 years old
able to understand spoken English
live in Western New York State (Erie or Niagara county)
have health insurance or ability to pay for health care
no methadone or buprenorphine treatment within past year
not member of a vulnerable population (e.g., pregnancy, prisoner)

Exclusion Criteria:

homelessness
unable to give consent (e.g., dementia, psychosis)
serious heart or lung disease
taking a medication that could interact with methadone or buprenorphine
pregnancy