anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lurasidone Hydrochloride
Trial phase: Phase 3
SMILES: Cl.O=C1C2C3CCC(C3)C2C(=O)N1CC1CCCCC1CN1CCN(c2nsc3ccccc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 419
Group description: Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
Eligibility criteria:
Main Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
Subject voluntarily agrees to participate in the study by giving written informed consent.

Main Exclusion Criteria:

To be excluded from entering this study if they fulfil any of the criteria below:

Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Intervention: Risperidone
Trial phase: Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 202
Group description: Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
Eligibility criteria:
Main Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
Subject voluntarily agrees to participate in the study by giving written informed consent.

Main Exclusion Criteria:

To be excluded from entering this study if they fulfil any of the criteria below:

Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Intervention: Prasugrel
Trial phase: Phase 2
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
Eligibility criteria:
Inclusion Criteria:

Type 2 Diabetes Mellitus and on oral or parenteral hypoglycemic therapy for at least 1 month.
History of Coronary Artery Disease with or without other types of vascular disease (such as peripheral vascular disease).
Taking Aspirin 75-325 mg/day for at least 1 week prior to randomization.
Between the ages of 18-74 years old.
If a woman of child bearing age, must not be pregnant and must agree to use reliable method of birth control during the duration of the study.

Exclusion Criteria:

Thienopyridine therapy within 30 days or have a defined need for thienopyridine treatment.
Coronary Artery Bypass Graft (CABG) or Percutaneous Coronary Intervention (PCI) with no stent placed within 30 days.
Planned coronary revascularization
Hemoglobin A1c (HbA1c) > or equal to 10 mg/dL within the last 3 months.
Received fibrolytic therapy <24 hours prior to randomization.
Received non-fibrin-specific fibrinolytic therapy <48 hours prior to randomization.
At risk of bleeding.
History of ischemic stroke, transient ischemic attack (TIA), intercranial neoplasm, arteriovenous malformation, or aneurysm.
Body weight <60 kilograms (kg).
International Normalized Ratio (INR) >1.5, platelet count <100,000/mm3, or anemia (hemoglobin <10 gm/dL) within 1 week of study entry.
Are receiving or will receive oral anticoagulation or antiplatelet treatment therapy.
Are being treated with daily non-steroidal anti-inflammatory drugs (NSAIDS).
Are pregnant, breast-feeding or plan to become pregnant.
Intervention: Clopidogrel
Trial phase: Phase 2
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
Eligibility criteria:
Inclusion Criteria:

Type 2 Diabetes Mellitus and on oral or parenteral hypoglycemic therapy for at least 1 month.
History of Coronary Artery Disease with or without other types of vascular disease (such as peripheral vascular disease).
Taking Aspirin 75-325 mg/day for at least 1 week prior to randomization.
Between the ages of 18-74 years old.
If a woman of child bearing age, must not be pregnant and must agree to use reliable method of birth control during the duration of the study.

Exclusion Criteria:

Thienopyridine therapy within 30 days or have a defined need for thienopyridine treatment.
Coronary Artery Bypass Graft (CABG) or Percutaneous Coronary Intervention (PCI) with no stent placed within 30 days.
Planned coronary revascularization
Hemoglobin A1c (HbA1c) > or equal to 10 mg/dL within the last 3 months.
Received fibrolytic therapy <24 hours prior to randomization.
Received non-fibrin-specific fibrinolytic therapy <48 hours prior to randomization.
At risk of bleeding.
History of ischemic stroke, transient ischemic attack (TIA), intercranial neoplasm, arteriovenous malformation, or aneurysm.
Body weight <60 kilograms (kg).
International Normalized Ratio (INR) >1.5, platelet count <100,000/mm3, or anemia (hemoglobin <10 gm/dL) within 1 week of study entry.
Are receiving or will receive oral anticoagulation or antiplatelet treatment therapy.
Are being treated with daily non-steroidal anti-inflammatory drugs (NSAIDS).
Are pregnant, breast-feeding or plan to become pregnant.
Intervention: Invokana
Trial phase: Phase 2
SMILES: Cc1ccc(C2OC(CO)C(O)C(O)C2O)cc1Cc1ccc(-c2ccc(F)cc2)s1.Cc1ccc(C2OC(CO)C(O)C(O)C2O)cc1Cc1ccc(-c2ccc(F)cc2)s1.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients must have a diagnosis of type 2 diabetes mellitus
Hemoglobin A1c levels >=7% and <=10.5%
taking a stable daily dose of metformin
Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2
Stable body weight
Serum creatinine <=1.5 mg/dL (132.6 umol/L) for men and <=1.4 mg/dL (123.76 umol/L) for women

Exclusion Criteria:

Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)
Known contraindication or suspected hypersensitivity to sitagliptin or metformin
A history of diabetic ketoacidosis or type 1 diabetes mellitus
History of pancreas or beta-cell transplantation
History of active proliferative diabetic retinopathy
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Intervention: Allopurinol
Trial phase: Phase 4
ATC code: M04AA01 | M04AA51
SMILES: Oc1ncnc2[nH]ncc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Allopurinol: 300-600 mg/day over a 6 week period
Eligibility criteria:
Inclusion Criteria:

Subjects must be between ages 18 and 70.
Subjects must meet DSM-IV criteria for bipolar disorder, most recent episode manic or mixed, at the time of screening confirmed by the Mini International Neuropsychiatric Interview (MINI).
Subjects must be taking at least one medication for mania (lithium, valproic acid, carbamazepine) at a therapeutic dose for at least 4 weeks.
Subjects must have non-response or partial response to medications as evidenced by Young Mania Rating Scale (YMRS) score greater than or equal to 14 at screening and at baseline.
Female subjects must be either postmenopausal for at least 1 year, surgically sterile, abstinent or practicing an effective method of birth control if sexually active. Female subjects must also have a negative urine pregnancy test at screening, baseline and other time points throughout the study.
Subjects must be able and willing to comply with self-administration of medication or have consistent help/support available.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Subjects must be able and willing to meet or perform study requirements (e.g. answer self-administered questionnaires).
Subjects must be willing to allow study staff to contact subject's regular psychiatrist while the subject is in the study.

Exclusion Criteria:

Subjects who are unable to provide informed consent.
Subjects with a serious, unstable medical illness (such as cardiovascular, respiratory, neurologic, hematologic, renal, hepatic, endocrine, immunologic, or other systemic illness), a history of cerebrovascular disease, uncontrolled diabetes mellitus or AIDS. Subjects with chronic illness must be stable and otherwise physically healthy on the basis of a physical examination, medical history, electrocardiogram and the results of blood biochemistry, hematology tests and a urinalysis.
Subjects with a history of substance abuse or dependence (excluding nicotine and caffeine) according to DSM-IV criteria within last 4 weeks.
Subjects taking azathioprine, mercaptopurine, apalcillin, and/or amoxicillin.
Subjects taking dopamine agonists and/or anti-psychotics.
Subjects who have been intoxicated with alcohol or illicit drugs within 3 days prior to baseline.
Subjects with a history of severe pre-existing gastrointestinal narrowing or inability to swallow oral study medication whole with the aid of water.
Female subjects who are pregnant or nursing.
Subjects who have previously participated in this study.
Subjects with an anticipated life expectancy of 6 months or less.
Subjects who have received an experimental drug or used an experimental medical device within 1 month of screening.
Intervention: Ranolazine
Trial phase: Phase 4
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 171
Group description: In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
Eligibility criteria:
Inclusion Criteria:

At least 3 months of documented history of stable angina or angina equivalents that is relieved by rest and/or sublingual NTG
Taking antianginal therapy with beta-blockers, and/or dihydropyridine calcium antagonists, and/or long-acting nitrates for at least 4 weeks
Mean angina frequency of ≥ 2 attacks per week
Documented clinical evidence of ischemia

Exclusion Criteria:

Clinically significant hepatic impairment
Uncontrolled clinically significant cardiac arrhythmias or a history of ventricular fibrillation, torsades de points, or other life-threatening ventricular arrhythmias not associated with acute coronary syndrome
Treatment with strong cytochrome P450 inhibitors including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, or saquinavir
Prior treatment with ranolazine
End-stage renal disease requiring dialysis
Myocardial infarction or unstable angina
Intervention: Clopidogrel
Trial phase: Not Applicable
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: All subjects received a 300 mg loading dose of clopidogrel
Eligibility criteria:
Inclusion Criteria:

Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention

Exclusion Criteria:

Acute coronary syndrome
Unable to tolerate clopidogrel
Intervention: Propranolol
Trial phase: Phase 4
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Weekly doses of short and long acting propranolol following recollection of traumatic memory
Eligibility criteria:
Inclusion Criteria:

OEF/OIF veteran diagnosed with combat related posttraumatic stress disorder

Exclusion Criteria:

Not diagnosed with current, chronic PTSD
Current PTSD related to a traumatic event other than the event being treated
Age>65.
Systolic blood pressure <100 mm HG or resting HR less than 60 BPM.
Medical condition that contraindicates the administration of propranolol, e.g. history of congestive heart failure, heart block, insulin-requiring diabetes, chronic bronchitis, emphysema, or asthma. With regard to asthma, because many persons who say they have had an asthma attack, especially as a child, may only have had hay fever, another allergy, or another non-asthmatic episode, a blanket exclusion criteria may be overly restrictive. Therefore asthma attacks will only be exclusionary if they a) occurred within the past 10 years, b) occurred at any time in life if induced by a beta-blocker, or c) are currently being treated, regardless of the date of last occurrence. Cardiological consultation will be obtained as necessary;
Previous adverse reaction to, or non-compliance with a beta-blocker.
Current use of medication that may involve potentially dangerous interactions with propranolol, including, other beta-blockers, antiarrhythmics, calcium channel blockers, and potent P450 2D6 inhibitors, e.g., fluoxetine, paroxetine, micnazole, sulconazole, metaclopramide, quinidine, ticlopidine, and ritnavir.
Presence of drugs of abuse, viz., opiates, marijuana, cocaine, or amphetamines, as determined by urine testing.
Pregnancy (in women of child- bearing potential, a pregnancy test will be performed) or breast feeding.
Contraindicating psychiatric condition, e.g., current psychotic, bipolar, melancholic, or substance dependence or abuse disorder.
Initiation of, or change in, psychotropic medication within the previous two months. For subjects receiving stable doses of pharmacotherapy, they and their providers will be asked not to change the regimen except in clinically urgent circumstances. If this becomes necessary, a decision will be made on a case-by-case basis whether to retain the subject in the study or terminate participation.
Current participation in any psychotherapy (other than supportive). Subjects will be asked not to initiate psychotherapy during the course of the proposed study except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis whether to retain the subject in the study or terminate participation.
Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation.
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 3
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 201
Group description: Loteprednol etabonate 0.5% ophthalmic ointment
Eligibility criteria:
Inclusion Criteria:

Subjects who are candidate for routine, uncomplicated cataract surgery
Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:

Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit
Intervention: Lubiprostone
Trial phase: Phase 4
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 57
Group description: lubiprostone (Amitiza): 24 mcg administered 4 times over the two days of the colon preparation with PEG plus electrolytes before the colonoscopy. 96 mcg total lubiprostone
Eligibility criteria:
Inclusion Criteria:

Subject is at least 18 years old
Subject is in good health
Subject is undergoing a screening, surveillance or diagnostic colonoscopy
Subject has a spontaneous bowel movement at least every 48 hours

Exclusion Criteria:

Subject has renal insufficiency demonstrated by serum creatinine > 1.4mg/dL
Subject has Type 1 diabetes
Subject has past or present diagnosis of Congestive Heart Failure
Subject has past or present diagnosis of inflammatory bowel disease
Subject had previous colon resection
Subject has a preexisting electrolyte abnormality
Subject has more than 3 spontaneous bowel movements daily
Intervention: Memantine
Trial phase: Phase 4
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: 20
Group description: Memantine: 10 mg bid
Eligibility criteria:
Inclusion Criteria:

Subjects must be between the ages of 18 and 80 inclusive.
Each subject must meet standard criteria for PD.
All patients on dopaminergic therapy must report benefit. -No other abnormal neurological signs. -No direct or indirect trauma to the nervous system within 3 months preceding the onset of PD. -No convincing evidence of sudden onset or evidence of stepwise deterioration.
Subjects must be in generally good health as evidenced by previous medical history and clinical examination.
Subjects will be allowed to take any PD medication with the exception of amantadine. They will also be allowed to take medications approved for the use of Alzheimer's disease.
Subjects will be required to be on a stable dose of all medications for at least two weeks prior to entry into the study and may not alter these medications throughout the study.
If subjects are on an anti-depressant medications, a stable dose of these will be required for at least six weeks prior to entry into the study.
Subjects must be accessible by telephone.
If the subject is a female of childbearing age, she must have had: a hysterectomy, or tubal ligation, or otherwise be incapable or pregnancy, or have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility.
Female of childbearing age must have had a negative urine pregnancy test within one week of study entry. 11. Prior to participation in this study, each subject must sign an informed consent.

Exclusion Criteria:

Subjects who do not meet inclusion criteria.
Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.
Subjects who can not maintain an identical dose of any medicine that may affect PD symptoms or signs during their entire study involvement.
Subjects who have exhibited meaningful psychiatric disease not thought to be related to PD. (Depression and psychosis typical for PD will not be excluded). 5. Subjects who have previously taken memantine.

6. Subjects currently taking Amantadine. 7. Subjects with greater than moderate dementia (MMSE<24). 8. Subjects with co-morbid disease that in the investigators decision could interfere with treatment with memantine.
Intervention: Doxercalciferol
Trial phase: Phase 4
ATC code: H05BX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
Eligibility criteria:
Inclusion Criteria:

Kidney transplant recipient > 18 year/old with reduced and stable kidney function (estimated GFR 25-60 ml/min/1.73m2)
iPTH levels between 120 and 500 pg/ml
Stable immunosuppressive therapy (5-10 mg Prednisone/day, stable dosage of calcineurin inhibitors, or other immunosuppressive agents for at least 6 months)

Exclusion Criteria:

Recent rejection episode (< 3 months)
One of the following: baseline estimated GFR>60 ml/min/1.73m2 or <25 ml/min/1.73m2, albumin-corrected Ca>9.5 mg/dl or serum phosphorus >4.6 mg/dl.
Recipients of dual transplant organs with exception of kidney-pancreas
Patients already receiving treatment with Vitamin D analogues
Severe peripheral vascular disease or coronary artery disease
History of previous parathyroidectomy
Current alcohol or drug abuse
Pregnant or nursing woman or female of child-bearing age not receiving contraception
Other comorbidities that in the opinion of the investigators would reduce expected patient's survival and preclude study completion
Medications that could interfere with Hectorol® metabolism