anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Aripiprazole
Trial phase: Phase 4
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: Male
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
Eligibility criteria:
Inclusion Criteria:

Male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder.

Exclusion Criteria:

Clinically significant laboratory and/or ECG abnormalities
Pre-existing health conditions that would compromise patient safety
Mental retardation
Previous use of aripiprazole
Active psychosis
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 680
Group description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)

Exclusion Criteria:

Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
Use of antacids [except for study supplied Gelusil®]
Need for continuous anticoagulant therapy (blood thinners)
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 668
Group description: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)

Exclusion Criteria:

Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
Use of antacids [except for study supplied Gelusil®]
Need for continuous anticoagulant therapy (blood thinners)
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 690
Group description: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)

Exclusion Criteria:

Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
Use of antacids [except for study supplied Gelusil®]
Need for continuous anticoagulant therapy (blood thinners)
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 694
Group description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).

Exclusion Criteria:

Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
Use of antacids [except for study supplied Gelusil®]
Need for continuous anticoagulant therapy (Blood Thinners)
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 687
Group description: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).

Exclusion Criteria:

Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
Use of antacids [except for study supplied Gelusil®]
Need for continuous anticoagulant therapy (Blood Thinners)
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 673
Group description: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).

Exclusion Criteria:

Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
Use of antacids [except for study supplied Gelusil®]
Need for continuous anticoagulant therapy (Blood Thinners)
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 312
Group description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
History of episodes of heartburn for 6 months or longer prior to screening.
History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.

Exclusion Criteria:

Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study·
Use of antacids (except for study supplied Gelusil®).
Use of drugs with significant anticholinergic effects.
Need for continuous anticoagulant (blood thinner) therapy.
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus.
History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter).
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy.
Erosive Esophagitis seen on endoscopy during study screening.
Co-existing diseases affecting the esophagus.
Abnormal laboratory values that suggest significant clinical disease.
Known acquired immunodeficiency syndrome (AIDS)
Females pregnant or lactating.
History of Alcohol abuse.
History of Cancer within 3 years prior to screening.
Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 304
Group description: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
History of episodes of heartburn for 6 months or longer prior to screening.
History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.

Exclusion Criteria:

Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study·
Use of antacids (except for study supplied Gelusil®).
Use of drugs with significant anticholinergic effects.
Need for continuous anticoagulant (blood thinner) therapy.
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus.
History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter).
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy.
Erosive Esophagitis seen on endoscopy during study screening.
Co-existing diseases affecting the esophagus.
Abnormal laboratory values that suggest significant clinical disease.
Known acquired immunodeficiency syndrome (AIDS)
Females pregnant or lactating.
History of Alcohol abuse.
History of Cancer within 3 years prior to screening.
Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 312
Group description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.

History of episodes of heartburn for 6 months or longer prior to screening.
History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.

Exclusion Criteria:

Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study
Erosive Esophagitis seen on endoscopy during study screening.
Co-existing diseases affecting the esophagus.
Abnormal laboratory values that suggest significant clinical disease.
Known acquired immunodeficiency syndrome (AIDS)
Females pregnant or lactating.
History of Alcohol abuse.
History of Cancer within 3 years prior to screening.
Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
Use of antacids (except for study supplied Gelusil® )
Use of drugs with significant anticholinergic effects
Need for continuous anticoagulant (blood thinner) therapy
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 304
Group description: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.

History of episodes of heartburn for 6 months or longer prior to screening.
History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.

Exclusion Criteria:

Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study
Erosive Esophagitis seen on endoscopy during study screening.
Co-existing diseases affecting the esophagus.
Abnormal laboratory values that suggest significant clinical disease.
Known acquired immunodeficiency syndrome (AIDS)
Females pregnant or lactating.
History of Alcohol abuse.
History of Cancer within 3 years prior to screening.
Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
Use of antacids (except for study supplied Gelusil® )
Use of drugs with significant anticholinergic effects
Need for continuous anticoagulant (blood thinner) therapy
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy
Intervention: Nesiritide
Trial phase: Phase 1 | Phase 2
ATC code: C01DX19
SMILES: CCC(C)C1NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(Cc2ccccc2)NC(=O)C(NC(=O)CNC(=O)C(CO)NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C2CCCN2C(=O)C(N)CO)C(C)C)CSSCC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2c[nH]cn2)C(=O)O)C(C)C)NC(=O)CNC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: BNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Resting left ventricular ejection fraction (LVEF) of 35% or less (determined within 48 months of recruitment by echocardiography, multiple gate acquisition scan (MUGA) or left ventriculogram.)
New York Heart Association (NYHA) Class I (with previous symptoms of heart failure), Class II and III
Female subjects not menopausal or surgically sterilized will need to have a negative pregnancy test the day before the study day and be on contraception.

Exclusion Criteria:

Myocardial infarction (MI) within 3 months of screening.
Unstable angina within 14 days of screening, or any evidence of myocardial ischemia.
Valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis.
Sustained ventricular tachycardia (VT) or ventricular fibrillation (V-fib) within 14 days of screening.
Second or third degree atrioventricular (AV) block without a permanent cardiac pacemaker.
Cerebrovascular accident (CVA) within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion.
Serum creatinine of >3.0 mg/dL.
Serum sodium of <125 milliequivalents per decaLiter (mEq/dL) or > 160 mEq/dL.
Serum potassium of < 3.5 mEq/dL or > 5.2 mEq/dL.
Serum digoxin level of > 2.0 ng/ml.
Systolic pressure of <85 mmHg immediately prior to the first injection of study drug/placebo.
LVEF > 35% by within 24 months of screening.
Unable to self-administer subcutaneous injection twice a day.
Diagnosed with AIDS or known positive HIV titer.
Other acute or chronic medical conditions or laboratory abnormality, which may increase the risks, associated with study participation or may interfere with interpretation of the data.
Received an investigational drug within 1 month prior to dosing.
Unable to undergo cardiac magnetic resonance imaging (MRI). Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips, or severe claustrophobia.
In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons.
Patient in atrial fibrillation or who have a pacemaker or implantable cardioverter defibrillator (ICD)
Hemoglobin < 10g/dl.
Patients with an allergy to iodine.
Intervention: CANDESARTAN CILEXETIL
Trial phase: Phase 3
SMILES: CCOc1nc2cccc(C(=O)OC(C)OC(=O)OC3CCCCC3)c2n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 949
Group description: Candesartan cilexetil 32 mg once daily
Eligibility criteria:
Inclusion Criteria:

Male or female aged 37 - 75 years with type 2 diabetes diagnosed at age of 36 years or thereafter.
Duration of diabetes for > 1 year and < 20 years with stable diabetic therapy within last 6 months.
Patients with untreated resting mean sitting SBP < 130 mmHg and mean sitting DBP < 85 or treated resting mean SBP < 160 mmHg and mean sitting DBP < 90 mmHg with retinal photograph grading level >20/10 up to < 47/47 (on ETDRS severity scale).

Exclusion Criteria:

Patients with the following conditions are excluded from participation in the study:
Cataract or media opacity of a degree which precludes taking gradable retinal photographs
Angle closure glaucoma, which precludes pharmacological dilatation of the pupil
History of or presence of proliferative retinopathy
History or presence of clinical significant macular oedema (CSME)
History or evidence of photocoagulation of the retina
Other retinal conditions which may mask assessment, eg, retinal vein occlusion
Positive micral dipstick test
Presence of secondary diabetes
Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception
Need of treatment with ACE-inhibitor
Haemodynamically significant aortic or mitral valve stenosis
Known renal artery stenosis or kidney transplantation
Hypersensitivity to study drug
Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator