anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ibutilide
Trial phase: Not Applicable
ATC code: C01BD05
SMILES: CCCCCCCN(CC)CCCC(O)c1ccc(NS(C)(=O)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
Eligibility criteria:
Inclusion Criteria:

Males and females will be enrolled in the study.
Age >18
Referred for a first ever ablation procedure for symptomatic persistent/permanent AF (only prior ablation of right-sided typical flutter is permitted)
All patients must understand the requirements of the study and be willing to comply with the post study follow-up requirements.
Patients must be in atrial fibrillation on the day of the procedure

Exclusion Criteria:

Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
Patients with a myocardial infarction or unstable angina in the previous 2 months.
Patients with a history of rheumatic heart disease
Patients with congenital heart disease
Patients with a history of hypertrophic cardiomyopathy
Patients with LV ejection fraction < 35%
Class IV congestive heart failure
Patients who have experienced any cerebral ischemic event, including any TIA in the preceding 1 month.
Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure.
Patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
Patients whose life expectancy is less than one year.
History of malignant ventricular arrhythmias or long QT interval (>500msec)
Prior left-sided cardiac ablation procedure (catheter based or surgical)
Mental impairment precluding the patient from providing informed consent or completing the appropriate follow up
Intervention: Montelukast
Trial phase: Phase 4
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Montelukast (LTRA) administered with moderate dose of inhaled steroid

Montelukast: 10 mg Q day
Eligibility criteria:
Inclusion Criteria:

moderate persistent asthma as defined daily symptoms, nocturnal awakenings >1 time/week but not daily, daily short-acting beta agonist usage
pre-bronchodilator Force expiratory volume (FEV1)>55% but <90%.
Subjects must be on controller therapy for asthma with ICS for at least one month prior to enrollment.
methacholine testing that causes a drop in the FEV1 of 20% (8mg/ml off ICS or 16mg/ml) on ICS within 6 months prior to entry
physician diagnosis of asthma for at least one year prior to study enrollment.
Obesity defined as BMI greater than 30.
subjects must have an Asthma Control Questionnaire (ACQ) score >1.25 on the Juniper Asthma Control Questionnaire (indicating poor asthma control),
require daily medications for asthma and be compliant with study related medications.

Exclusion Criteria:

Subjects must not have been intubated in the last 5 years or unstable asthma symptoms resulting in significant loss or work or school
upper or lower respiratory tract infection within 1 month of the study
use of antibiotics within 4 weeks of the study
use of oral glucocorticoids within 4 weeks
use of theophylline
smoking history greater than 10 pack years or any cigarette use within the past two years
significant non-asthma pulmonary disease or other medical problems
Subjects planning to undergo gastric bypass surgery within 4 months of the enrollment date will be excluded since weight loss is a potential confounder of asthma control
Pregnant women will also be excluded
Intervention: Metronidazole
Trial phase: Phase 4
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 270
Group description: Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
Eligibility criteria:
Inclusion Criteria:

Female
18 years or older
HIV-positive
TV positive by either wet preparation or culture
ability to refrain from all alcohol use for 24 hours before and after taking oral metronidazole
willing to take metronidazole treatment

Exclusion Criteria:

pregnant
incarcerated
previously enrolled
currently taking disulfiram
alcoholism or known liver damage
medical contraindications to metronidazole
treated with metronidazole within the previous 14 days
requires treatment for B.V. per Amsel's criteria
Intervention: Moxifloxacin
Trial phase: Phase 1
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: 400 mg capsule at the 6 hour point
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-55 years of age, non smoking and non-pregnant, weighing at least 55kg and within 15% of ideal body weight, with no significant EKG changes

Exclusion Criteria:

Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
History or family history of congenital long QT syndrome (LQTS) or sudden death possibly related to LQTS
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose and throughout the study
Intervention: Medroxyprogesterone acetate
Trial phase: Not Applicable
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 132
Group description: Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)

Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Eligibility criteria:
Inclusion Criteria:

age greater than or equal to 18 years
seeking DMPA for contraception
English or Spanish speaking
consistent access to a working telephone
availability for follow up for one year

Exclusion Criteria:

suspected or continuing pregnancy
undiagnosed vaginal bleeding
known or suspected breast cancer
acute liver disease
known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
desire for pregnancy within one year
Intervention: Medroxyprogesterone acetate
Trial phase: Not Applicable
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 132
Group description: Clinic administration (routine care) of DMPA

Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Eligibility criteria:
Inclusion Criteria:

age greater than or equal to 18 years
seeking DMPA for contraception
English or Spanish speaking
consistent access to a working telephone
availability for follow up for one year

Exclusion Criteria:

suspected or continuing pregnancy
undiagnosed vaginal bleeding
known or suspected breast cancer
acute liver disease
known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
desire for pregnancy within one year
Intervention: Diclofenac Potassium
Trial phase: Phase 4
SMILES: O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[K+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections
Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study

Exclusion Criteria:

History of hypersensitivity to any drugs or excipients of the study
Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications
Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding
Neurological and hemodynamics disorders
Evidence of liver or kidney impairment or heart failure
Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours)
Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Triptorelin
Trial phase: Phase 3
ATC code: L02AE04
SMILES: CC(C)C[C@H](NC(=O)[C@@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 325
Group description: Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
Eligibility criteria:
Inclusion Criteria:

A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment.
An estimated survival time of at least twelve months according to the investigator's assessment.
A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria.

Exclusion Criteria:

Previous surgical castration.
Previous or has planned curative prostate cancer therapy (radiation/surgery)
Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)
Patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)
Intervention: Paricalcitol
Trial phase: Phase 3
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
Eligibility criteria:
Inclusion Criteria:

Subject has chronic kidney disease Stage 3 or 4 as determined by estimated glomerular filtration rate (15 to 59 mL/min/1.73 m²) at Screening.
Subject is not expected to begin dialysis for at least 6 months (in the opinion of the investigator).

For entry into the Washout Period (for subjects who are currently on a vitamin D receptor activator [VDRA] and need to complete a 2 to 4 week washout), the subject must satisfy the following criteria based on the Screening laboratory values:

estimated glomerular filtration rate between 15 to 59 mL/min/1.73 m².
iPTH measurement that is greater than or equal to 60 pg/mL (Stage 3 subjects) or greater than or equal to 90 pg/mL (Stage 4 subjects).
An adjusted serum calcium value greater than or equal to 8.2 mg/dL (2.05 mmol/L) to less than or equal to 10.5 mg/dL (2.63 mmol/L).
A serum phosphorus value greater than or equal to 2.0 mg/dL (0.65 mmol/L but less than or equal to 6.0 mg/dL (1.94 mmol/L).

For entry into the Treatment Phase (vitamin D receptor activator naïve subjects and those that have completed a 4 week washout), the subject must have:

iPTH measurement that is greater than or equal to 75 pg/mL (Stage 3 subjects) or greater than or equal to 110 pg/mL (Stage 4 subjects).
An adjusted serum calcium value greater than or equal to 8.4 mg/dL (2.10 mmol/L) but less than or equal to 10.2 mg/dL (2.55 mmol/L).
A serum phosphorus value greater than or equal to 2.5 mg/dL (0.81 mmol/L) but less than or equal to 5.8 mg/dL (1.87 mmol/L).
Must have 25-hydroxyvitamin D levels ≥ 30 ng/mL prior to washout, if not VDRA naïve, or treatment in Part II of the study.

Exclusion Criteria:

All subjects that have had a small bowel transplant will be excluded from the study.
Subject has had acute kidney failure within 12 weeks of the Screening Phase (defined as an acute rise in serum creatinine).
Subject has had symptomatic or significant hypocalcemia requiring active vitamin D therapy (for example, calcitriol, paricalcitol, doxercalciferol or alfacalcidol) within 6 months prior to the Screening Phase.
Subject has a history of active kidney stones (6 months prior to screening).
Subject has chronic gastrointestinal disease, which in the investigator's opinion may cause significant gastrointestinal malabsorption.
Subject is taking maintenance calcitonin, bisphosphonates, cinacalcet, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 weeks prior to treatment.
Intervention: Paricalcitol
Trial phase: Phase 3
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Participants received paricalcitol three times a week (TIW) for 12 weeks during the double-blind treatment period. The initial dose of paricalcitol was 1 µg TIW. Doses could be adjusted based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) levels.
Eligibility criteria:
Inclusion Criteria:

Subject has chronic kidney disease Stage 3 or 4 as determined by estimated glomerular filtration rate (15 to 59 mL/min/1.73 m²) at Screening.
Subject is not expected to begin dialysis for at least 6 months (in the opinion of the investigator).

For entry into the Washout Period (for subjects who are currently on a vitamin D receptor activator [VDRA] and need to complete a 2 to 4 week washout), the subject must satisfy the following criteria based on the Screening laboratory values:

estimated glomerular filtration rate between 15 to 59 mL/min/1.73 m².
iPTH measurement that is greater than or equal to 60 pg/mL (Stage 3 subjects) or greater than or equal to 90 pg/mL (Stage 4 subjects).
An adjusted serum calcium value greater than or equal to 8.2 mg/dL (2.05 mmol/L) to less than or equal to 10.5 mg/dL (2.63 mmol/L).
A serum phosphorus value greater than or equal to 2.0 mg/dL (0.65 mmol/L but less than or equal to 6.0 mg/dL (1.94 mmol/L).

For entry into the Treatment Phase (vitamin D receptor activator naïve subjects and those that have completed a 4 week washout), the subject must have:

iPTH measurement that is greater than or equal to 75 pg/mL (Stage 3 subjects) or greater than or equal to 110 pg/mL (Stage 4 subjects).
An adjusted serum calcium value greater than or equal to 8.4 mg/dL (2.10 mmol/L) but less than or equal to 10.2 mg/dL (2.55 mmol/L).
A serum phosphorus value greater than or equal to 2.5 mg/dL (0.81 mmol/L) but less than or equal to 5.8 mg/dL (1.87 mmol/L).
Must have 25-hydroxyvitamin D levels ≥ 30 ng/mL prior to washout, if not VDRA naïve, or treatment in Part II of the study.

Exclusion Criteria:

All subjects that have had a small bowel transplant will be excluded from the study.
Subject has had acute kidney failure within 12 weeks of the Screening Phase (defined as an acute rise in serum creatinine).
Subject has had symptomatic or significant hypocalcemia requiring active vitamin D therapy (for example, calcitriol, paricalcitol, doxercalciferol or alfacalcidol) within 6 months prior to the Screening Phase.
Subject has a history of active kidney stones (6 months prior to screening).
Subject has chronic gastrointestinal disease, which in the investigator's opinion may cause significant gastrointestinal malabsorption.
Subject is taking maintenance calcitonin, bisphosphonates, cinacalcet, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 weeks prior to treatment.
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
Eligibility criteria:
Inclusion Criteria:

Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.
Intervention: Bromfenac
Trial phase: Phase 4
ATC code: S01BC11
SMILES: Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 126
Group description: Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18 years of age or older
Scheduled for cataract surgery by phacoemulsification
Subjects must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria:

Any subject that has a history of uveitis or active iritis
Subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month
No ocular use of prostaglandins within 2 weeks of surgery
Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
Active ocular infection
Intervention: Nepafenac
Trial phase: Phase 4
ATC code: S01BC10
SMILES: NC(=O)Cc1cccc(C(=O)c2ccccc2)c1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 126
Group description: Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18 years of age or older
Scheduled for cataract surgery by phacoemulsification
Subjects must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria:

Any subject that has a history of uveitis or active iritis
Subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month
No ocular use of prostaglandins within 2 weeks of surgery
Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
Active ocular infection
Intervention: Ketorolac Tromethamine
Trial phase: Phase 4
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 126
Group description: Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18 years of age or older
Scheduled for cataract surgery by phacoemulsification
Subjects must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria:

Any subject that has a history of uveitis or active iritis
Subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month
No ocular use of prostaglandins within 2 weeks of surgery
Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
Active ocular infection
Intervention: Silicon Dioxide
Trial phase: Phase 2
SMILES: O=[Si]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 38
Group description: Crude indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil,petroleum jelly and wax.
Eligibility criteria:
Inclusion Criteria:

Patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study;
Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years;
Patients were in good general health.
Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.

Exclusion Criteria:

Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%;
Patients had a history of allergy to indigo naturalis.
Patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment.
Patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.
Intervention: Gliclazide
Trial phase: Phase 4
ATC code: A10BB09 | G01AE10
SMILES: Cc1ccc(S(=O)(=O)NC(=O)NN2CC3CCCC3C2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 219
Group description: 80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes
Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
Lipid-lowing agent naïve
HbA1c: 6.5-8.5%
Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)
Body Mass Index (BMI): 20-35 kg/m^2
Be able and willing to perform self-monitored plasma glucose (SMPG)
Be able and willing to eat 3 main meals per day
Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits

Exclusion Criteria:

Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
Previous participation in this study
Participation in a study of another investigational drug within 1 month prior to study start