anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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
Healthy volunteers: No
Participants at risk: 951
Group description: Candesartan cilexetil 32 mg once daily
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18 - 55 years with type 1 diabetes diagnosed before age of 36 years and in need for continuous insulin treatment within 1 year of diagnosis of diabetes are included.
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, mean sitting DBP < 85 mmHg and 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 on 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 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
Intervention: Trazodone
Trial phase: Phase 3
ATC code: N06AX05
SMILES: O=c1n(CCCN2CCN(c3cccc(Cl)c3)CC2)nc2ccccn12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: 50-150mg at bedtime
Eligibility criteria:
Inclusion Criteria:

Recent methadone maintenance enrollment
Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)
No medical contraindications to trazodone

Exclusion Criteria:

Methadone maintenance enrollment not recent
No sleep complaints as measured by the PSQI
Medical contraindications to trazodone
Intervention: VALPROIC ACID
Trial phase: Phase 4
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: Participants will receive 9 weeks of treatment with lithium.

Lithium (LI): The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of DSM-IV Bipolar Disorder, Type I: current manic, mixed, or hypomanic episodes

Exclusion Criteria:

Rapid cycling bipolar disorder
History of substance abuse or dependence within last 3 months
Diagnosis of schizophrenia or other chronic psychotic conditions
Acute or unstable medical illness
Documented intolerance to Lithium, Depakote, Risperidone, or Lorazepam
Dementia
Inability to communicate in English
Intervention: VALPROIC ACID
Trial phase: Phase 4
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: Participants will receive 9 weeks of treatment with divalproex.

Divalproex (DV): Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of DSM-IV Bipolar Disorder, Type I: current manic, mixed, or hypomanic episodes

Exclusion Criteria:

Rapid cycling bipolar disorder
History of substance abuse or dependence within last 3 months
Diagnosis of schizophrenia or other chronic psychotic conditions
Acute or unstable medical illness
Documented intolerance to Lithium, Depakote, Risperidone, or Lorazepam
Dementia
Inability to communicate in English
Intervention: Memantine
Trial phase: Phase 3
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: 10mg Memantine
Eligibility criteria:
Inclusion Criteria:1. Dementia criteria by DSM-IV.

2. 50-95 years of age inclusive.

3. MMSE at screen and baseline 7-28 inclusive.

4. Conversant in English.

5. Caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.

6. Able to ingest oral medication. Exclusion Criteria:1. History of clinically significant stroke without substantial recovery.

2. Neurological or medical conditions causing significant disability independent of dementia.

3. Parkinson's disease.

4. History in past two years of focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.

5. Dementia due to Korsakoff's syndrome or infectious diseases such as Creutzfeldt-Jakob disease, herpes, encephalitis, or human immunodeficiency virus.

6. Sensory impairment that would prevent subject from participating in or cooperating with the protocol.

7. Significant clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including: clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality.

8. Clinical contraindication to the use of memantine (e.g., hypersensitivity).

9. History of seizure within past 5 years prior to screening.

10. Platelet count < 100,000/mm3.

11. History of claustrophobia

12. Presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
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: 159
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.
Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
Need for continuous anticoagulant therapy.
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: 152
Group description: Dexlansoprazole MR 90 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.
Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
Need for continuous anticoagulant therapy.
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: 159
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 TEE04-085 (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.
Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
Need for continuous anticoagulant therapy.
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: 152
Group description: Dexlansoprazole MR 90 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 TEE04-085 (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.
Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
Need for continuous anticoagulant therapy.
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: 153
Group description: Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
Eligibility criteria:
Inclusion Criteria:

Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.

Exclusion Criteria:

Any condition that may require inpatient surgery during the course of the study.
Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
Use of antacids [except for study supplied Gelusil®].
Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
Evidence of uncontrolled systemic disease.
Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
Need to take blood thinners.
Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
Has had radiation or cryotherapy to the esophagus.
Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
History of alcohol abuse.
Has acquired immunodeficiency syndrome.
Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
Received a blood product transfusion within 3 months of taking the first dose of study drug.
Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.
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: 438
Group description: Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
Eligibility criteria:
Inclusion Criteria:

Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.

Exclusion Criteria:

Any condition that may require inpatient surgery during the course of the study.
Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
Use of antacids [except for study supplied Gelusil®].
Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
Evidence of uncontrolled systemic disease.
Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
Need to take blood thinners.
Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
Has had radiation or cryotherapy to the esophagus.
Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
History of alcohol abuse.
Has acquired immunodeficiency syndrome.
Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
Received a blood product transfusion within 3 months of taking the first dose of study drug.
Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.
Intervention: Anastrozole
Trial phase: Phase 2
ATC code: L02BG03
SMILES: CC(C)(C#N)c1cc(Cn2cncn2)cc(C(C)(C)C#N)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Anastrozole: 1 mg. oral every day for 2 - 4 weeks
Eligibility criteria:
Inclusion Criteria:

Patients must have suspicion of DCIS or early invasive breast cancer on mammography.
Patients must have histologically confirmed diagnosis of DCIS or early invasive breast cancer on core biopsy for final registration.
Patients must be over 18 years of age

"Patients must be postmenopausal as defined by one of the following criteria:

Prior bilateral oophorectomy OR
> 12 months since LMP with no prior hysterectomy OR
a & b not applicable AND age >=50
Patients must be positive for either ER or PR or both
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

Patients must not have diagnosis of osteoporosis (T-score -2.5 according to the WHO)
Intervention: Anastrozole
Trial phase: Phase 3
ATC code: L02BG03
SMILES: CC(C)(C#N)c1cc(Cn2cncn2)cc(C(C)(C)C#N)c1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 254
Group description: Anastrozole 1 mg
Eligibility criteria:
Inclusion Criteria:

Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis

Exclusion Criteria:

Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
Premenopausal women
Intervention: Almotriptan Malate
Trial phase: Phase 3
SMILES: CN(C)CCc1c[nH]c2ccc(CS(=O)(=O)N3CCCC3)cc12.O=C(O)CC(O)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 420
Group description: Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
Eligibility criteria:
Inclusion Criteria:

Have a history of migraine for at least one year
Have an average of 1 - 14 migraines per month for the 6 months prior to study entry
Able to swallow oral medication
Able to complete a headache diary
Only taking one migraine preventive medication and on the same dose of that medication for at least 30 days before entering the study)

Exclusion Criteria:

Have an allergy to almotriptan malate or have stopped taking almotriptan malate due to side effects
Have 15 or more days within a month in which you have a headache
Usually experience migraine aura (most common symptoms being visual disturbances or tingling sensations before migraine pain begins) without a headache
Experience more than 6 non-migraine headaches per month
Intervention: Zidovudine
Trial phase: Phase 2
ATC code: J05AF01 | J05AR01 | J05AR04 | J05AR05
SMILES: Cc1cn([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Granulocyte-Macrophage Colony-Stimulating Factor
Eligibility criteria:
Inclusion Criteria:

Patient must have: metastatic, disseminated or recurrent colon or rectal cancer
Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent) given once weekly 5FU/leucovorin/irinotecan given once weekly
Patient must be able to be taught to administer GM-CSF subcutaneously

Exclusion criteria:

Known allergic or other adverse reaction to GM-CSF
Chemotherapy administration more frequently than bi-weekly
Pregnant or lactating women
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 207
Group description: Pitavastatin 1 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and postmenopausal females (aged 65 years and older
Eligible, able to participate, have given informed consent
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
Agree to be available

Exclusion Criteria

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus (HbA1c >8%).
Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
Liver injury
Impaired renal function
Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
Serum CK >5 x ULRR without clinical explanation
Uncontrolled hypothyroidism defined as TSH >ULRR
Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
Major surgery, 3 months prior to Visit 1
Significant CVD prior to randomization
Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of > 100 beats per minute at rest.
Left ventricular ejection fraction <0.25;
History of symptomatic cerebrovascular disease
Any other conditions at the discretion of the investigator
Known HIV infection
Poorly controlled or uncontrolled hypertension
Prior or current known muscular or neuromuscular disease of any type;
Neoplastic disease
Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
Current or recent use of supplements known to alter lipid metabolism
History of hypersensitivity to other HMG-CoA reductase inhibitors;
Concomitant medication not permitted
Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
Excessive obesity
Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.