anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Omeprazole
Trial phase: Not Applicable
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Adding 40mg omeprazole QD for 14 days
Eligibility criteria:
Inclusion Criteria for PPI initiation study:

Cirrhosis not on current PPI or acid suppressive therapy
No systemic antibiotics or probiotics

Exclusion Criteria for PPI initiation study:

On systemic antibiotics
On PPI or acid suppression therapy already
unable to give informed consent
Allergy to proton pump inhibitors

Inclusion Criteria for PPI withdrawal study:

Cirrhosis on current PPI for an FDA-unapproved indication
No systemic antibiotics or probiotics

Exclusion Criteria for PPI withdrawal study:

On systemic absorbable antibiotics
On PPI or acid suppression therapy for an FDA-approved indication
unable to give informed consent
unwilling to withdraw PPI
Intervention: Omeprazole
Trial phase: Not Applicable
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: The intervention here is systematically withdrawing chronic PPI for 14 days
Eligibility criteria:
Inclusion Criteria for PPI initiation study:

Cirrhosis not on current PPI or acid suppressive therapy
No systemic antibiotics or probiotics

Exclusion Criteria for PPI initiation study:

On systemic antibiotics
On PPI or acid suppression therapy already
unable to give informed consent
Allergy to proton pump inhibitors

Inclusion Criteria for PPI withdrawal study:

Cirrhosis on current PPI for an FDA-unapproved indication
No systemic antibiotics or probiotics

Exclusion Criteria for PPI withdrawal study:

On systemic absorbable antibiotics
On PPI or acid suppression therapy for an FDA-approved indication
unable to give informed consent
unwilling to withdraw PPI
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Eligibility criteria:
Inclusion Criteria:

Women

Ages 40-65
Peri- and postmenopausal
Suffering from fatigue
Experiencing hot flashes(Not required for perimenopausal women)

Exclusion Criteria:

Current episode of major depression
Moderate-to-severe insomnia
Night shift workers
Previous diagnosis of manic depressive disorder, psychotic disorder, or psychotic symptoms
Suicidal ideation
Alcohol/drug abuse
Concern about potential misuse of study medication
Use of prescribed medications to treat insomnia or other sleep disturbance symptoms
Pregnant or breastfeeding
Use of systemic menopausal hormonal therapy or birth control
Use of centrally active medications, such as antidepressants, anxiolytics, and hypnotics agents
Use of clopidogrel
Use of atomoxetine
Cardiovascular contraindications of use of armodafinil
Intervention: Aliskiren
Trial phase: Phase 4
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.

378 patients were enrolled for screening, and 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group.
Eligibility criteria:
Inclusion Criteria:

Segment: outpatients
Hypertension: taking an anti-hypertensive treatment or indicating mean sitting SBP/DBP more than130/80 mmHg
Type 2 diabetes: diagnosed by ADA criteria or under an anti-diabetic drug treatment
Microalbuminuria: 10 < and < 300 mg/gCr
Informed consent: patients who understand well about this study based on own voluntary will and can give a written consent

Exclusion Criteria:

Sever hypertension (over 180/110 mmHg), malignant hypertension and secondary hypertension
Type 1 diabetes
Patients whose investigator regards as difficult to comply with study protocol in reference to the package insert of aliskiren
Patients who have history of operation in gastrointestinal tract surgery, and anamnestic or concurrent gastrointestinal disorders, which may interfere with drug absorption
Serum potassium > 5.6 mEq/L (hyperkalemia)
Urinary microalbumin < 10 or > 300 mg/gCr
Patients who participated in another clinical study within three months
Intervention: Sevoflurane
Trial phase: Not Applicable
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
Eligibility criteria:
Inclusion Criteria:

male adults
aged 18-80 yr
undergoing elective OPCAB surgery containing left anterior descending artery bypass

Exclusion Criteria:

a previous unusual response to any of the experimental anesthetics
severe cardiac dysrhythmias or ejection fraction below 30%
hemodynamic instability
previous surgical coronary artery repair
anemia, abnormal leukocytes or coagulopathy
severe hypertension
severe hepatic (albumin<30g,ascites), renal (serum creatinine greater than 2.0 mg/dl) or pulmonary (preoperative pulmonary function tests moderate-severe) dysfunctions
concomitant surgical procedures and psychiatric disorders
Insulin-dependent diabetics
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
Eligibility criteria:
Inclusion Criteria:

male adults
aged 18-80 yr
undergoing elective OPCAB surgery containing left anterior descending artery bypass

Exclusion Criteria:

a previous unusual response to any of the experimental anesthetics
severe cardiac dysrhythmias or ejection fraction below 30%
hemodynamic instability
previous surgical coronary artery repair
anemia, abnormal leukocytes or coagulopathy
severe hypertension
severe hepatic (albumin<30g,ascites), renal (serum creatinine greater than 2.0 mg/dl) or pulmonary (preoperative pulmonary function tests moderate-severe) dysfunctions
concomitant surgical procedures and psychiatric disorders
Insulin-dependent diabetics
Intervention: Retapamulin
Trial phase: Phase 4
ATC code: D06AX13
SMILES: [H][C@@]12C(=O)CC[C@]13CC[C@@H](C)[C@@]2(C)[C@H](OC(=O)CS[C@@H]1C[C@H]2CC[C@@H](C1)N2C)C[C@@](C)(C=C)[C@@H](O)[C@@H]3C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of retapamulin with follow up bilateral nares swab one week following completion of therapy (~D12) to assess clearance. If follow up swabs are positive for MRSA, patients will be given a second course of the same agent (retapamulin) to begin one week following swab collection (~D19-23) so that up to two decolonization attempts will be made. A final set of bilateral nares swabs will be obtained from all subjects six weeks from the completion of initial treatment (~D47).

Retapamulin: Two times a day for 5 days
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Have a type of MRSA that is resistant to mupirocin (a drug used to treat MRSA)

Exclusion Criteria:

Allergic to retapamulin
Unable to use retapamulin via your nose (i.e. nose surgery, etc.)
Are pregnant and/or breastfeeding
Intervention: Medroxyprogesterone acetate
Trial phase: Phase 3
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: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Depot medroxyprogesterone acetate (DMPA):150mg DMPA, IM, every 12 weeks for 12 months
Eligibility criteria:
Inclusion Criteria:

Age 12-21 years
Healthy, post-menarcheal female
Self-selected to initiate depot medroxyprogesterone acetate (DMPA)
Willingness to use a barrier method of contraception in addition to DMPA

Exclusion Criteria:

Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes, kidney)
Use of medication known to affect weight or BMD (e.g. corticosteroids)
DMPA use within the past 12 months
Pregnancy within the past 6 months
Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal ring)
Weight exceeding 450 lbs
Need for confidential contraceptive care for individuals < 18 years of age.
Intervention: Celecoxib
Trial phase: Phase 3
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Celecoxib : 200 mg Capsules
Eligibility criteria:
Inclusion Criteria:

Patient is male or female between 18 and 65 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening
Intervention: Sumatriptan
Trial phase: Phase 3
ATC code: G01AE10 | N02CC01
SMILES: CNS(=O)(=O)Cc1ccc2[nH]cc(CCN(C)C)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: Sumatriptan : Sumatriptan 20mg
Eligibility criteria:
Inclusion Criteria:

Men or women, between the ages of 18 to 65 years
Diagnosis of migraine, with or without aura
Experiences between 1 and 8 migraine attacks per month for the past 12 months

Exclusion Criteria:

Inability to distinguish other headaches from migraine
Experiences headache of any kind at a frequency greater than or equal to 15 days per month
History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as subjects who have not responded to an adequate dose and duration of treatment
Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
Chronic opioid therapy (>3 consecutive days in the 30 days prior to screening)
Intervention: Fenofibrate
Trial phase: Phase 4
ATC code: C10AB05 | C10BA03 | C10BA04 | C10BA09 | C10BA12
SMILES: CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 492
Group description: fenofibrate: Fenofibrate Capsule 200mg qd orally
Eligibility criteria:
Inclusion Criteria:

≥18 years and < 80 years, male or female

With at least one risk of coronary heart disease (CHD) [medical history of myocardial infarction (MI) or coronary angiography shows coronary stenosis ≥ 50% or post percutaneous coronary intervention (PCI) or post coronary artery bypass grafting (CABG)] or CHD risk equivalents, which comprise,

Other clinical forms of atherosclerotic disease (ischemic stroke, peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease)
Type 2 Diabetes
Multiple risk factors that confer a 10-year risk for CHD >20%.
≥ 2 months statin monotherapy with standard dose (atorvastatin ≤20mg q.d. or rosuvastatin ≤10mg q.d. or simvastatin ≤40mg q.d. or pravastatin ≤40mg q.d. or pitavastatin ≤4mg q.d or fluvastatin ≤80mg q.d. or lovastatin ≤40mg q.d.) and plan to continue the previous type and dose of statin
Triglycerides (TG)≥1.70 mmol/L (150mg/dl) and TG<5.65 mmol/L (500mg/dl)
Subject must be able to provide informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), on his or her own behalf, prior to any study-specific procedures.

Exclusion Criteria:

Hypersensitive to fenofibrate or to any of its excipients
Hepatic insufficiency [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2ULN (upper limit of normal)]
Renal insufficiency [Creatinine clearance rate (Ccr)<60ml/min estimated from Cockcroft-Gault equation Ccr=(140-age)*weight(Kg)*0.85(if female)/[0.818*Cr (µmol/L)]
Creatine kinase (CK) > 2 ULN
Congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency
Hypothyroidism
Combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months
Combination use of drug with similar structure as Fenofibrate, especially ketoprofen
Combination use of oral anticoagulants
Pregnant or lactating woman
Other conditions at investigator's discretion
Intervention: Lemborexant
Trial phase: Phase 1
ATC code: N05CJ02 | N05CM21
SMILES: Cc1ncc(OC[C@@]2(c3cccc(F)c3)C[C@H]2C(=O)Nc2ccc(F)cn2)c(C)n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Healthy Subjects:

With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800
Who report typical sleep latency of </= 30 minutes
With typical total sleep time (TST) >/= 420 minutes

Primary Insomnia Subjects:

Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months
With a score of > 15 on the Insomnia Severity Index (ISI) at Screening
Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the past month
Who report 6.5 hours sleep or less on at least 3 nights per week for the past month
With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes with neither night < 15 minutes
With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with neither night < 15 minutes or mean TST > 420 minutes

Key Exclusion Criteria:

With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for Part B)
Subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ECG finding, or laboratory test results which require medical treatment
All females must be of non-childbearing potential
With a known history of significant neurological or serious psychiatric illness
Intervention: Lemborexant
Trial phase: Phase 1
ATC code: N05CJ02 | N05CM21
SMILES: Cc1ncc(OC[C@@]2(c3cccc(F)c3)C[C@H]2C(=O)Nc2ccc(F)cn2)c(C)n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Healthy Subjects:

With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800
Who report typical sleep latency of </= 30 minutes
With typical total sleep time (TST) >/= 420 minutes

Primary Insomnia Subjects:

Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months
With a score of > 15 on the Insomnia Severity Index (ISI) at Screening
Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the past month
Who report 6.5 hours sleep or less on at least 3 nights per week for the past month
With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes with neither night < 15 minutes
With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with neither night < 15 minutes or mean TST > 420 minutes

Key Exclusion Criteria:

With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for Part B)
Subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ECG finding, or laboratory test results which require medical treatment
All females must be of non-childbearing potential
With a known history of significant neurological or serious psychiatric illness
Intervention: Lemborexant
Trial phase: Phase 1
ATC code: N05CJ02 | N05CM21
SMILES: Cc1ncc(OC[C@@]2(c3cccc(F)c3)C[C@H]2C(=O)Nc2ccc(F)cn2)c(C)n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Healthy Subjects:

With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800
Who report typical sleep latency of </= 30 minutes
With typical total sleep time (TST) >/= 420 minutes

Primary Insomnia Subjects:

Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months
With a score of > 15 on the Insomnia Severity Index (ISI) at Screening
Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the past month
Who report 6.5 hours sleep or less on at least 3 nights per week for the past month
With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes with neither night < 15 minutes
With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with neither night < 15 minutes or mean TST > 420 minutes

Key Exclusion Criteria:

With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for Part B)
Subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ECG finding, or laboratory test results which require medical treatment
All females must be of non-childbearing potential
With a known history of significant neurological or serious psychiatric illness
Intervention: Lemborexant
Trial phase: Phase 1
ATC code: N05CJ02 | N05CM21
SMILES: Cc1ncc(OC[C@@]2(c3cccc(F)c3)C[C@H]2C(=O)Nc2ccc(F)cn2)c(C)n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Healthy Subjects:

With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800
Who report typical sleep latency of </= 30 minutes
With typical total sleep time (TST) >/= 420 minutes

Primary Insomnia Subjects:

Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months
With a score of > 15 on the Insomnia Severity Index (ISI) at Screening
Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the past month
Who report 6.5 hours sleep or less on at least 3 nights per week for the past month
With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes with neither night < 15 minutes
With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with neither night < 15 minutes or mean TST > 420 minutes

Key Exclusion Criteria:

With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for Part B)
Subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ECG finding, or laboratory test results which require medical treatment
All females must be of non-childbearing potential
With a known history of significant neurological or serious psychiatric illness