anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lamivudine
Trial phase: Phase 3
ATC code: J05AF05 | J05AR01 | J05AR02 | J05AR04 | J05AR05 | J05AR07 | J05AR11 | J05AR12 | J05AR13 | J05AR16 | J05AR24 | J05AR25 | J05AR27
SMILES: Nc1ccn([C@@H]2CS[C@H](CO)O2)c(=O)n1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 53
Group description: LAM 100 mg orally once daily for 52 weeks
Eligibility criteria:
Inclusion criteria:

Have compensated chronic hepatitis B.
Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
Ability to read, understand, and sign the informed consent.
Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L

Exclusion criteria:

Having or suspected of having liver cancer.
Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
Autoimmune hepatitis.
Received any previous transplantation or having a plan for any transplantation.
Existence of any serious complication, except hepatitis B.
Intervention: Omeprazole
Trial phase: Phase 2
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: 319
Group description: Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Eligibility criteria:
Inclusion Criteria:

Adults with diagnosis of asthma since at least 6 months.
Symptoms of asthma during run-in.
At least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth.

Exclusion Criteria:

Patients with clinically relevant abnormalities.
Patients with a smoking history of ≥10 pack-year.
Patients who have had previous surgery on the esophagus or the stomach.
Intervention: Omeprazole
Trial phase: Phase 2
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: 313
Group description: Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Eligibility criteria:
Inclusion Criteria:

Adults with diagnosis of asthma since at least 6 months.
Symptoms of asthma during run-in.
At least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth.

Exclusion Criteria:

Patients with clinically relevant abnormalities.
Patients with a smoking history of ≥10 pack-year.
Patients who have had previous surgery on the esophagus or the stomach.
Intervention: Sucroferric oxyhydroxide
Trial phase: Phase 2 | Phase 3
ATC code: V03AE05
SMILES: O.O.O.OCC1OC(OC2(CO)OC(CO)C(O)C2O)C(O)C(O)C1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Heme Iron Polypeptide 11mg PO tid for 6 months
Eligibility criteria:
Inclusion Criteria:

eGFR &lt; 30 mL/min
Hb 90-110 g/L
Age &gt; 18
Not on renal replacement therapy
Transferrin saturation &lt; 20% OR Ferritin &lt;100 mcg/L
B12 & folate within reference range

Exclusion Criteria:

Iron overload (Tsat > 50% or ferritin > 800 μg/L);
malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months;
parenteral iron therapy, blood transfusion within the last 3 months;
pregnancy;
contraindication to any study medication and;
inability or refusal to give consent.
Intervention: Miglustat
Trial phase: Phase 3
ATC code: A16AX06
SMILES: CCCCN1C[C@H](O)[C@@H](O)[C@@H](O)[C@H]1CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Oral administration of miglustat 100 mg t.i.d. (median time exposure = 658 days)
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18 years or older
Type 1 Gaucher disease, diagnosed by glucocerebrosidase assay or molecular analysis of the glucocerebrosidase gene.
Treatment with ERT for at least 3 years, with a stable dose regimen for at least the last 6 months.

Clinically and biologically stable disease for the previous 2 years, with at least 2 time points assessments (including baseline as one potential time point), defined as:

Stable organomegaly (assessed by magnetic resonance imaging (MRI) or computed tomography (CT)):

Liver volume within 10% of the mean.
Spleen volume within 10% of the mean.
Free of progressive symptomatic documented bone disease.
Hemoglobin levels > 11g/dl
Mean platelet count > 100x10^9 /l.

Chitotriosidase activity within 20% of the mean.

If chitotriosidase is not available (in the case of chitotriosidase deficiency, or if it was not determined), other relevant biomarkers (e.g., angiotensin converting enzyme (ACE), tartrate resistant acid phosphatase (TRAP) and ferritin) could be considered.
Written informed consent.

Exclusion Criteria:

History or evidence of oculomotor gaze palsy, ataxia or other clinical manifestations typically associated with neuronopathic type 3 Gaucher disease.
Not ambulant patients, or with progressive symptomatic documented bone disease.
Splenectomy before 18 years of age for splenomegaly and/or thrombocytopenia.
Peripheral polyneuropathy (not mononeuropathy) documented with both clinical signs and symptoms, and electrodiagnostic (EDX).
Patients (males and females) who do not agree to use reliable contraception throughout the study and for 3 months after cessation of miglustat treatment.
Female patients who are pregnant or breast feeding, or without pregnancy test prior to Day 1.
History of significant lactose intolerance.
Clinically significant diarrhea (>3 liquid stools per day for >7 days) without definable cause within 6 months prior to Day 1, or a history of clinically relevant gastrointestinal disorders.
History of cataracts or known increased risk of cataract formation.
Severe renal impairment i.e., with a creatinine clearance <30 ml/min/1.73m^2
Concomitant active medical condition such as human immunodeficiency virus (HIV) or hepatitis B/C that would render patients unsuitable for study.
Previous treatment with miglustat.
Intervention: Bosentan
Trial phase: Phase 3
ATC code: C02KX01 | G01AE10
SMILES: COc1ccccc1Oc1c(NS(=O)(=O)c2ccc(C(C)(C)C)cc2)nc(-c2ncccn2)nc1OCCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 151
Group description: Oral bosentan

Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)
Eligibility criteria:
Inclusion Criteria:

Patients having completed the 16-week treatment period of protocol AC-052-366 (NCT00313222)
Signed informed consent

Exclusion Criteria:

Any major violation of protocol AC-052-366 (NCT00313222)
Pregnancy or breast-feeding
Intervention: Diltiazem
Trial phase: Phase 2 | Phase 3
ATC code: C05AE03 | C08DB01
SMILES: COc1ccc([C@@H]2Sc3ccccc3N(CCN(C)C)C(=O)[C@@H]2OC(C)=O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
Eligibility criteria:
Inclusion Criteria:

Preclinical HCM (identified sarcomere mutation with no clinical evidence of left ventricular hypertrophy)
Able to provide informed consent (or parental consent)

Exclusion Criteria:

Contraindication to diltiazem administration
Impaired hepatic or renal function
Age < 5 years
Pregnant or breastfeeding women
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 260
Group description: 10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of schizophrenia
Must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks.
Disease symptoms must meet a certain range as assessed by the clinician.
Patient has experienced at least two episodes of clinical worsening of their condition. This could mean admission to a hospital or an emergency room visit. This could mean that a new medication was added, medication dose was increased, or medication was switched in order to better control symptoms of the condition.
The patient must have an unsatisfactory response to their current medication or be experiencing negative effects of their current medication or not always take their current medication so that a change in current medication is desired.

Exclusion Criteria:

Patients who are actively suicidal.
Patients who are pregnant or nursing.
Patients who have stopped past treatment with olanzapine because of adverse events, are treatment resistant or allergic to olanzapine, or have a condition which would prevent use of a long acting form of olanzapine.
Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illness.
Patients with Parkinson's disease, psychosis related to dementia or other related disorders.
Intervention: Aripiprazole
Trial phase: Phase 4
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
Eligibility criteria:
Inclusion Criteria:

Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or similar psychotic disorder not otherwise specified, as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P)
History of previous antipsychotic medication treatment for a duration of 2 weeks or less
Current positive symptoms rated 4 (moderate) or more on one or more of the following Brief Psychiatric Rating Scale (BPRS-A) items: conceptual disorganization; grandiosity; hallucinatory behavior; or unusual thought content
Agrees to use an effective form of contraception

Exclusion Criteria:

Any serious neurological or endocrine disorder, or any medical condition or treatment known to affect the brain
Any current medical condition that requires treatment with a medication with psychotropic effects
At significant risk for suicidal or homicidal behavior
Cognitive or language limitations, or any other factor that would interfere with a participant's ability to provide informed consent or safely participate in study procedures
Diagnosis of diabetes, defined as a fasting plasma glucose level of at least 126 mg/dL, or metabolic syndrome, defined as three or more of the following: high blood pressure (greater than 135/85 mmHg); truncal obesity (having a waist circumference greater than 40 inches for men and greater than 35 inches for women); elevated fasting glucose (greater than 110 mg/dL); low HDL-cholesterol (less than 40 mg/dL for men and less than 50 mg/dL for women); or elevated triglycerides (defined as greater than 150 mg/dL)
Requires treatment with an antidepressant or mood stabilizing medication
Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features
Any medical conditions that would make treatment with risperidone or aripiprazole medically inadvisable
Intervention: Risperidone
Trial phase: Phase 4
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
Eligibility criteria:
Inclusion Criteria:

Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or similar psychotic disorder not otherwise specified, as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P)
History of previous antipsychotic medication treatment for a duration of 2 weeks or less
Current positive symptoms rated 4 (moderate) or more on one or more of the following Brief Psychiatric Rating Scale (BPRS-A) items: conceptual disorganization; grandiosity; hallucinatory behavior; or unusual thought content
Agrees to use an effective form of contraception

Exclusion Criteria:

Any serious neurological or endocrine disorder, or any medical condition or treatment known to affect the brain
Any current medical condition that requires treatment with a medication with psychotropic effects
At significant risk for suicidal or homicidal behavior
Cognitive or language limitations, or any other factor that would interfere with a participant's ability to provide informed consent or safely participate in study procedures
Diagnosis of diabetes, defined as a fasting plasma glucose level of at least 126 mg/dL, or metabolic syndrome, defined as three or more of the following: high blood pressure (greater than 135/85 mmHg); truncal obesity (having a waist circumference greater than 40 inches for men and greater than 35 inches for women); elevated fasting glucose (greater than 110 mg/dL); low HDL-cholesterol (less than 40 mg/dL for men and less than 50 mg/dL for women); or elevated triglycerides (defined as greater than 150 mg/dL)
Requires treatment with an antidepressant or mood stabilizing medication
Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features
Any medical conditions that would make treatment with risperidone or aripiprazole medically inadvisable
Intervention: TOLAZAMIDE
Trial phase: Phase 2
ATC code: A10BB05 | G01AE10
SMILES: Cc1ccc(S(=O)(=O)NC(=O)NN2CCCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Sulfonylurea-treated patients
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes mellitus diagnosed according to WHO criteria
Diet and/or metformin treatment
HbA1c > 7,0% for metformin treated patients
HbA1c > 7,5% for diet treated patients
Age: 18 years or older
25 > BMI > 40 kg/m2
Signed informed consent
Sufficient birth control in case of child bearing capacity

Exclusion Criteria:

Proliferative retinopathy
Diabetic nephropathy with s-creatinine > 130 microM and/or macroalbuminuria
Liver disease (ALAT > 2 x normal value)
CAD (NYHA group III or IV)
Positive screening for islet-cell and/or GAD-65 autoantibodies
Type 1 diabetes i first degree relatives
Gastrointestinal surgery with intestinal resection
Anemia
Pregnancy and/or breastfeeding
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: 140
Group description: Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
Eligibility criteria:
Inclusion Criteria:

Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Exclusion Criteria:

Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study.
Use of antacids (except for study supplied) throughout the study.
Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
Need for continuous anticoagulant therapy.
Evidence of uncontrolled systemic disease.
Subjects who have participated in either maintenance study (T-EE04-086 [NCT00255164] or T-EE04-087 [NCT00255151]).
Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is 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: 158
Group description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
Eligibility criteria:
Inclusion Criteria:

Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Exclusion Criteria:

Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study.
Use of antacids (except for study supplied) throughout the study.
Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
Need for continuous anticoagulant therapy.
Evidence of uncontrolled systemic disease.
Subjects who have participated in either maintenance study (T-EE04-086 [NCT00255164] or T-EE04-087 [NCT00255151]).
Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is 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: 315
Group description: Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).
Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.
Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.

Exclusion Criteria:

Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.
Subjects with erosive esophagitis (EE) as shown by endoscopy.
Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.
Subject has abnormal laboratory values.
Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.
Subject known to have acquired immunodeficiency syndrome (AIDS).
Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.
Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.
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.
Subjects who cannot discontinue the use of misoprostol or prokinetics
Need for continuous anticoagulant therapy.
Females who are pregnant or lactating.
History of gastrointestinal surgery except for simple oversew of ulcer.
History of cancer within 3 years prior to screening.
Subject has participated in a previous Dexlansoprazole study.
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: 315
Group description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).
Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.
Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.

Exclusion Criteria:

Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.
Subjects with erosive esophagitis (EE) as shown by endoscopy.
Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.
Subject has abnormal laboratory values.
Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.
Subject known to have acquired immunodeficiency syndrome (AIDS).
Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.
Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.
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.
Subjects who cannot discontinue the use of misoprostol or prokinetics
Need for continuous anticoagulant therapy.
Females who are pregnant or lactating.
History of gastrointestinal surgery except for simple oversew of ulcer.
History of cancer within 3 years prior to screening.
Subject has participated in a previous Dexlansoprazole study.
Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.