anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 756
Group description: Febuxostat 80 mg, orally, once daily for up to 6 months.
Eligibility criteria:
Inclusion Criteria:

Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
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.
Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).

Exclusion Criteria:

Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
History of xanthinuria.
Alcohol consumption greater than 14/week.
History of significant concomitant illness.
Active liver or peptic ulcer disease.
Has rheumatoid arthritis requiring treatment.
Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.
Intervention: Allopurinol
Trial phase: Phase 3
ATC code: M04AA01 | M04AA51
SMILES: Oc1ncnc2[nH]ncc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 756
Group description: Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
Eligibility criteria:
Inclusion Criteria:

Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
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.
Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).

Exclusion Criteria:

Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
History of xanthinuria.
Alcohol consumption greater than 14/week.
History of significant concomitant illness.
Active liver or peptic ulcer disease.
Has rheumatoid arthritis requiring treatment.
Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.
Intervention: Solifenacin
Trial phase: Phase 4
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Solifenacin succinate: 5 mg tablets, taken orally, once daily
Eligibility criteria:
Inclusion Criteria:

Adults 18 years and older.
Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: > 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)

Exclusion Criteria:

Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
Clinically significant outflow obstruction
Uncontrolled narrow angle glaucoma, urinary, or gastric retention
Severe renal or hepatic impairment
Chronic severe constipation or history of diagnosed GI obstructive disease
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
Diagnosis or history of neurogenic bladder
History of bladder or pelvic cancer
Intervention: Estradiol
Trial phase: Phase 3
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 336
Group description: One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women whose last menstruation was at least two years prior to the time of screening
At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity
Generally healthy

Exclusion Criteria:

Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months
Intervention: Azithromycin
Trial phase: Phase 4
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 131
Group description: azithromycin 250 mg tablets

azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs

*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs
Eligibility criteria:
Inclusion Criteria:

Male or female, 6-18 years of age at enrollment
Confirmed diagnosis of CF
Written informed consent (and assent when applicable)
Clinically stable at enrollment as assessed by the site investigator
FEV1 % predicted > 50%
Ability to comply with medication use, study visits, and study procedures
Ability to swallow a 250 mg tablet

Exclusion Criteria:

Weight less than 18.0 kg
Respiratory culture positive for P. aeruginosa, NTM, or B. cepacia complex within 1 year or at screening, or AFB positive at screening
Allergy to macrolide antibiotics
Use of macrolide antibiotics (e.g., azithromycin, clarithromycin) within 60 days of screening
Use of systemic corticosteroids or intravenous or oral antibiotics within 14 days of screening
Initiation of high dose ibuprofen, Pulmozyme®, hypertonic saline or aerosolized antibiotics within 30 days of screening
Chronic therapy with drugs known to have rare but serious interactions with azithromycin: amiodarone, digoxin, disopyramide, lovastatin, pimozide, rifabutin, and nelfinavir
Investigational drug use within 30 days of screening
Laboratory abnormalities (creatinine, liver function or neutropenia) at screening and confirmed at follow-up testing prior to randomization
History of biliary cirrhosis, portal hypertension, or splenomegaly, or splenomegaly on physical exam
History of ventricular arrhythmia
Other major organ dysfunction, excluding pancreatic dysfunction
History of lung transplantation or currently on lung transplant list
Relative decrease in FEV1 % predicted ≥ 20% between the screening and enrollment visit
Positive serum pregnancy test at screening
Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study
History of alcohol, illicit drug or medication abuse within 1 year of screening in the judgment of the site investigator
Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data
Intervention: Telcagepant
Trial phase: Phase 3
SMILES: O=C(N[C@@H]1CC[C@@H](c2cccc(F)c2F)CN(CC(F)(F)F)C1=O)N1CCC(n2c(=O)[nH]c3ncccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 177
Group description: MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
Eligibility criteria:
Inclusion Criteria:

Patient has at least 1 year history of migraine (with or without aura)
Females of childbearing years must use acceptable contraception throughout trial

Exclusion Criteria:

Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
Patient has a history of cancer within the last 5 years
Intervention: Telcagepant
Trial phase: Phase 3
SMILES: O=C(N[C@@H]1CC[C@@H](c2cccc(F)c2F)CN(CC(F)(F)F)C1=O)N1CCC(n2c(=O)[nH]c3ncccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 381
Group description: MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
Eligibility criteria:
Inclusion Criteria:

Patient has at least 1 year history of migraine (with or without aura)
Females of childbearing years must use acceptable contraception throughout trial

Exclusion Criteria:

Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
Patient has a history of cancer within the last 5 years
Intervention: Telcagepant
Trial phase: Phase 3
SMILES: O=C(N[C@@H]1CC[C@@H](c2cccc(F)c2F)CN(CC(F)(F)F)C1=O)N1CCC(n2c(=O)[nH]c3ncccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 370
Group description: MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Eligibility criteria:
Inclusion Criteria:

Patient has at least 1 year history of migraine (with or without aura)
Females of childbearing years must use acceptable contraception throughout trial

Exclusion Criteria:

Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
Patient has a history of cancer within the last 5 years
Intervention: Ubidecarenone
Trial phase: Phase 3
ATC code: C01EB09
SMILES: COC1=C(OC)C(=O)C(CC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)C)=C(C)C1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 19
Group description: CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed. (Either in Period 1 or Period 2)
Eligibility criteria:
Inclusion Criteria:

Age 12 m - 17 y
Biochemical proof of a deficiency of complex I, III or IV of the RC or a molecular genetic proof of a mutation in mtDNA, or an nDNA mutation in a gene known to be associated with dysfunction of the electron transport chain (e.g., SURF1)
Willingness to stop all other medication regimens and supplements other than what the Steering and Planning Committee deems medically necessary

Exclusion Criteria:

A genetic mitochondrial disease other than those stipulated under inclusion criteria
Intractable epilepsy, defined as grand mal seizures occurring with a frequency > 4/month, despite treatment with conventional antiepileptic drugs
Primary, defined organic acidurias other than lactic acidosis (e.g., propionic aciduria
Primary disorders of amino acid metabolism
Primary disorders of fatty acid oxidation
Secondary lactic acidosis due to impaired oxygenation or circulation (e.g., due to severe cardiomyopathy or congenital heart defects)
Severe anemia, defined as a hematocrit <30%
Malabsorption syndromes associated with D-lactic acidosis
Renal insufficiency, defined as (1) a requirement for chronic dialysis or (2) serum creatinine ≥ 1.2 mg/dl or creatinine clearance <60 ml/min
Primary hepatic disease unrelated to mitochondrial disease
Allergy to CoQ10 or placebo ingredients
Pregnancy
Intervention: Ephedrine
Trial phase: Phase 2
ATC code: A08AA56 | C01CA26 | R01AA03 | R01AB05 | R01BA02 | R01BA52 | R03CA02 | S01FB02
SMILES: CN[C@@H](C)[C@@H](O)c1ccccc1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: IM Ephedrine

Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time
Eligibility criteria:
Inclusion Criteria:

Must be pregnant with a single baby
Must be at term in their pregnancy (estimated gestational age of at least 38 weeks)
Must be scheduled for an elective Cesarean section
Must be between 60-70" tall
Must be free of severe systemic disease (ASA class I or II)

Exclusion Criteria:

Contraindication to spinal anesthesia
Any allergy to any of the medications included in the study
History of pregnancy-induced hypertension or preeclampsia
History of preexisting hypertension
Diabetes mellitus
Hyperemesis gravidum
Previous perioperative nausea and vomiting
History of motion sickness
Women carrying a fetus with a known abnormality will also be excluded from the study
Intervention: Testosterone
Trial phase: Phase 3
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 234
Group description: Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
Eligibility criteria:
Inclusion Criteria:

Low T males 18 - 80 years of age

Exclusion Criteria:

Normal T levels
Elevated Prostatic Specific Antigen (PSA)
Intervention: Duloxetine
Trial phase: Phase 3
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 128
Group description: duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
Previous exposure to duloxetine.
Intervention: Methylphenidate
Trial phase: Phase 4
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 305
Group description: Methylphenidate Transdermal System (MTS)
Eligibility criteria:
Inclusion Criteria:

Must sign informed consent.
Male or female 6-12 years old.
Negative pregnancy test.
Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD.
No co-morbid illness that could affect safety, tolerability or interfere with participation.
Blood pressure (BP) within the 95th percentile for age, gender, and height.
Willing and able to comply with all the requirements defined in protocol.

Exclusion Criteria:

Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder [ODD]).
At risk for suicidal or violent behavior towards self or others.
History of a suicide attempt.
History of a structural cardiac abnormality or other serious cardiac problems.
Non-responder to psychostimulant treatment.
Is overweight.
Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
Has Conduct Disorder.
Known history of alcohol or other substance abuse within the last 6 months.
Any abnormal thyroid function.
A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments.
Has had treatment with any known liver altering agents within 30 days prior to Screening.
Taking any excluded medication.
Previous use of DAYTRANA.
Taking other medications that have Central Nervous System (CNS) effects.
Female subject is pregnant or lactating.
Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions.
Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites.
A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.
Intervention: Conivaptan
Trial phase: Phase 4
ATC code: C03XA02
SMILES: Cc1nc2c([nH]1)CCN(C(=O)c1ccc(NC(=O)c3ccccc3-c3ccccc3)cc1)c1ccccc1-2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
Eligibility criteria:
Inclusion Criteria:

Subject has a serum sodium value between 115 and 133 mEq/L
Subject is euvolemic or hypervolemic

Exclusion Criteria:

Clinical evidence of volume depletion or dehydration
Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment
Intervention: Conivaptan
Trial phase: Phase 4
ATC code: C03XA02
SMILES: Cc1nc2c([nH]1)CCN(C(=O)c1ccc(NC(=O)c3ccccc3-c3ccccc3)cc1)c1ccccc1-2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
Eligibility criteria:
Inclusion Criteria:

Subject has a serum sodium value between 115 and 133 mEq/L
Subject is euvolemic or hypervolemic

Exclusion Criteria:

Clinical evidence of volume depletion or dehydration
Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment
Intervention: Remifentanil
Trial phase: Phase 3
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
Eligibility criteria:
Inclusion Criteria:

Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.

Exclusion Criteria:

Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided

Concurrent medications:

Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation
Has or is likely to receive an epidural block during the treatment period
Intervention: Propofol
Trial phase: Phase 3
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Eligibility criteria:
Inclusion Criteria:

Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.

Exclusion Criteria:

Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided

Concurrent medications:

Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation
Has or is likely to receive an epidural block during the treatment period