anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Amphetamine
Trial phase: Not Applicable
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
Eligibility criteria:
Inclusion Criteria:

outpatient age 18 through 55 inclusive
meets DSM-IV criteria for obsessive-compulsive disorder (OCD) with Yale-Brown Obsessive-Compulsive Scale (YBOCS) score greater than or equal to 20
provides written informed consent
has taken for at least 12 weeks at least the dose shown of a selective serotonin reuptake inhibitor (SSRI) [citalopram, escitalopram, or fluoxetine 20 mg/d; paroxetine 40 mg/d; sertraline 50 mg/d]; or venlafaxine 225 mg/d; or duloxetine 60 mg/d.
if taking buspar, gabapentin, an atypical antipsychotic, or a benzodiazepine, dose has been stable for 4 weeks
has negative urine drug and pregnancy tests
is practicing reliable birth control method
has blood pressure readings at screening visit that are less than 140 mm Hg systolic and 90 mm Hg diastolic,
weight is greater than 100 lbs at screen

Exclusion criteria:

requires psychotropic medications other than an Serotonin Reuptake Inhibitor (SRI), a benzodiazepine, buspirone, an atypical antipsychotic, and/or gabapentin
is taking clomipramine
is taking fluvoxamine
is taking medication that inhibits hepatic enzyme CYP1A2
is taking a monoamine oxidase inhibitor
has co-morbid tics or Tourette's disorder
has hoarding as the primary or only OCD symptom
has a history of panic disorder
has a history of glaucoma
has a history of seizures
has a history of schizophrenia or psychotic disorder, or schizotypal personality disorder
has depression with current suicide risk
has mental retardation, pervasive developmental disorder, or cognitive disorder
has a factitious disorder
has current or past cyclothymic disorder or bipolar disorder
has a dissociative disorder
has personality disorder sufficient to interfere with study participation
has organic mental disorder or dementia
has current or past substance abuse / dependence (excluding nicotine)
has current or past anorexia or bulimia
has serious or unstable medical disorder, including hypertension or cardiac disease
has history of myocardial infarction or cardiac arrhythmia
has history of or has current diagnosis of hypertension
is pregnant or breast-feeding
is receiving psychotherapy for OCD
is intending to receive psychotherapy for OCD during the study
has had a previous trial of d-amphetamine of at least 30 days duration
is unable to speak, read, or understand English
is not likely to follow study procedures
is not suitable for study in the investigator's opinion
Intervention: Cyclosporine
Trial phase: Phase 2
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
Eligibility criteria:
INCLUSION CRITERIA:

All patients must have a histologic or cytologic diagnosis of T-cell LGL leukemia as determined by the Laboratory of Pathology or Hematology at the Clinical Center, National Institutes of Health
All patients must have hemocytopenias such as granulocyte count less than 1,200/ul, platelet count less than 100,000/ul or hemoglobin less than 10 g/dl, or require hematopoietic support (transfusion or colony stimulating factors) to maintain counts at these or higher levels.
Patients must have measurable or evaluable disease
Patients must have a creatinine of less than 2.0 mg/dl.
Omission of cytotoxic chemotherapy for 3 weeks prior to entry into the trial is required. However, patients receiving stable corticosteroids will be eligible.
Age greater than 18 years
Karnofsky performance greater than 70%
Patients must have a life expectancy of greater than 3 months.
Patients must be able to understand and sign an Informed Consent form.
All female patients must use adequate contraception during participation in this trial and for three months after completing therapy.

EXCLUSION CRITERIA:

Patients with uncontrolled hypertension
Pregnant and nursing patients are not eligible for the study as CSA crosses the placenta. Based on clinical use, premature births and low birth weight were consistently observed. Breast-feeding is contraindicated because CSA enters the blood milk and may possibly be administered to the child.
Underlying immunodeficiency state including human immunodeficiency virus (HIV) seropositivity.
Positive for antibodies to hepatitis C or positive for hepatitis B surface antigen,
Patients with serious intercurrent illnesses, concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious or metabolic disease of such severity that it would preclude the patients' ability to tolerate cyclosporine.
Patients who received cyclosporine for LGL leukemia previously and failed to respond.
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: People with impaired fasting glucose treated with sitagliptin 100mg once daily.
Eligibility criteria:
Twenty four participants aged 35 to 70 years with impaired fasting glucose (100mg/dl-125 mg/dl) will be studied.

Inclusion Criteria:

Males and females between the ages of 35-70.
Good health as determined by past medical history,physical examination, vital signs, electrocardiogram and laboratory tests at the time of screening.
Patients on diuretics or thyroid hormone therapy must be on a stable dose (at least 3 months prior to screening) and the maintenance dose may not be adjusted during the study.

Exclusion Criteria:

Individuals with a body mass index less than 19 or greater than 40 kg/m^2, or a total weight > 130 kg, will be excluded from study.
Subjects less than 35 years will not be studied in order to minimize the possibility of studying subjects with type 1 diabetes.
No history of a) significant nephropathy, (i.e., plasma creatinine > 1.4 mg/dl in women and 1.5 mg/dl in men, and/or proteinuria); b) clinically significant atherosclerotic vascular disease (e.g., history of heart attack or angina); c) a known systemic illness.
Pregnant or lactating females.
Intervention: Zopiclone
Trial phase: Phase 4
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: receipt of active drug
Eligibility criteria:
Inclusion Criteria:

Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant.
Age 20 - 75
Not currently regularly taking any prescribed sleeping pill more often than 4x/week.
Can tolerate oral medication.

Exclusion Criteria:

Patients with a current history of substance abuse
Patients with a history of allergic response to Lunesta.
Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.
Intervention: PCO-371
Trial phase: Phase 3
SMILES: Cc1cc(N2C(=O)NC(=O)C2(C)C)cc(C)c1CCS(=O)(=O)N1CCC2(CC1)N=C(c1ccc(OC(F)(F)F)cc1)NC2=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 405
Group description: Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84)
Eligibility criteria:
Inclusion Criteria:

Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply.

All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.

Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
Is the subject above 50 years old?
Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
Does the subject have primary osteoporosis with a lumbar spine T score < -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
Does the subject have a life expectancy of >3 years?
Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
Intervention: RISEDRONIC ACID
Trial phase: Phase 3
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 282
Group description: Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate
Eligibility criteria:
Inclusion Criteria:

Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply.

All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.

Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
Is the subject above 50 years old?
Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
Does the subject have primary osteoporosis with a lumbar spine T score < -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
Does the subject have a life expectancy of >3 years?
Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 321
Group description: Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Smokes at least 10 cigarettes a day on average for the past year
No prior diagnosis of cancer (unless completed treatment AND no evidence of disease within the past 5 years)
Able to use nicotine replacement therapy

PATIENT CHARACTERISTICS:

Able to communicate in English
Must reside in the geographic area for ≥ 6 months
Current asthma, ulcer, or diabetes allowed provided medical clearance from the participant's physician is obtained
No evidence of drug or alcohol abuse
No known HIV positivity

No heart disease, including any of the following:

Current diagnosis of coronary artery disease
Abnormal heart rhythm or an arrhythmia
Heart failure
Heart valve disease
Congenital heart disease
Heart muscle disease or cardiomyopathy
Pericardial disease
Aorta disease
Vascular disease
Myocardial infarction

High blood pressure (defined as blood pressure > 140/90 mm Hg) not receiving antihypertensive medication

History of or current high blood pressure controlled by antihypertensive medication and having medical clearance from physician allowed
No allergy to adhesive tape or latex
Not pregnant or nursing
Negative pregnancy test
Fertile participants must use effective contraception during and for ≥ 1 month prior to and after completion of study treatment

PRIOR CONCURRENT THERAPY:

At least 30 days since prior and no concurrent benzodiazepine (e.g., diazepam, alprazolam, or lorazepam)
At least 6 months since prior antiretroviral medications
At least 6 months since prior and no concurrent medication for depression (e.g., phenelzine sulfate, pargyline hydrochloride, tranylcypromine sulfate, paroxetine hydrochloride, sertraline hydrochloride, fluoxetine hydrochloride)
No concurrent antipsychotics (e.g., lithium) or theophylline
No concurrent substance abuse treatment
No concurrent bupropion hydrochloride
No other concurrent pharmacologic aid or any other form of formal assistance for smoking cessation
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 321
Group description: Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
Eligibility criteria:
DISEASE CHARACTERISTICS:

Smokes at least 10 cigarettes a day on average for the past year
No prior diagnosis of cancer (unless completed treatment AND no evidence of disease within the past 5 years)
Able to use nicotine replacement therapy

PATIENT CHARACTERISTICS:

Able to communicate in English
Must reside in the geographic area for ≥ 6 months
Current asthma, ulcer, or diabetes allowed provided medical clearance from the participant's physician is obtained
No evidence of drug or alcohol abuse
No known HIV positivity

No heart disease, including any of the following:

Current diagnosis of coronary artery disease
Abnormal heart rhythm or an arrhythmia
Heart failure
Heart valve disease
Congenital heart disease
Heart muscle disease or cardiomyopathy
Pericardial disease
Aorta disease
Vascular disease
Myocardial infarction

High blood pressure (defined as blood pressure > 140/90 mm Hg) not receiving antihypertensive medication

History of or current high blood pressure controlled by antihypertensive medication and having medical clearance from physician allowed
No allergy to adhesive tape or latex
Not pregnant or nursing
Negative pregnancy test
Fertile participants must use effective contraception during and for ≥ 1 month prior to and after completion of study treatment

PRIOR CONCURRENT THERAPY:

At least 30 days since prior and no concurrent benzodiazepine (e.g., diazepam, alprazolam, or lorazepam)
At least 6 months since prior antiretroviral medications
At least 6 months since prior and no concurrent medication for depression (e.g., phenelzine sulfate, pargyline hydrochloride, tranylcypromine sulfate, paroxetine hydrochloride, sertraline hydrochloride, fluoxetine hydrochloride)
No concurrent antipsychotics (e.g., lithium) or theophylline
No concurrent substance abuse treatment
No concurrent bupropion hydrochloride
No other concurrent pharmacologic aid or any other form of formal assistance for smoking cessation
Intervention: GLUTAMINE
Trial phase: Phase 2
ATC code: A16AA03
SMILES: NC(=O)CCC(N)C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.

Glutamine: Administered orally twice daily for 21 days
Eligibility criteria:
Inclusion Criteria:

Patients between the age of 5 and 21 years old.
Patients who demonstrate the ability to complete the assessment instruments at baseline.
Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of > or = to 6mg/m2 of vincristine, or > 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period.

Exclusion Criteria:

Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis.
Patients with recurrent disease.
Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam.
Patients who have already received > 8mg/m2 of vincristine, or > 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent.
Patients with hepatic encephalopathy or hyperammonemia.
Patients with a focally abnormal neurologic exam.
Intervention: Rosiglitazone
Trial phase: Phase 2
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
Eligibility criteria:
Inclusion Criteria:

Lipoatrophy
Thymidine sparing ARV for at least 24 weeks
Prior thymidine NRTIs for at least 12 months

Exclusion Criteria:

Diabetes
Heart failure
Liver disease
Hormonal therapies
Intervention: Brivaracetam
Trial phase: Phase 3
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
Eligibility criteria:
Inclusion Criteria:

- Subjects with diagnosed Unverricht-Lundborg disease (ULD) ascertained by appropriate genetic testing for a homozygous or compound heterozygous mutation in the CSTB gene- Subjects with moderate to severe myoclonus documented by an Action Myoclonussum score of ≥ 30 (evaluation by investigator)-Subjects currently being or having been treated with clonazepam up to the maximum recommended daily dose of 20 mg or up to their individual optimal dose as assessed by the investigator- Subjects currently being or having been treated with valproate up to the maximum recommended daily dose 60 mg/kg or serum levels of 100 mcg/ml or up to their individual optimal dose as specified by the investigator- Male/female subjects from 16 years onwards. Subjects under 18 years may only be included where legally permitted and ethically accepted

Exclusion Criteria:

- Subjects currently on felbamate or having been on felbamate within less than 18 months prior to Visit 1- Subjects currently treated with phenytoin or having been on phenytoin in the last month prior to Visit 1- Subjects currently on vigabatrine. Subjects having been on vigabatrine if no visual fields examination report available including standard static (Humphrey or Octopus) or cinetic perimetry (Goldman)- Subject taking any drug with possible central nervous system (CNS) effects- Subjects taking any drug that may significantly influence the metabolism of BRV (CYP2C or CYP3A potent inducers/inhibitors)- Known clinically significant acute or chronic illness or illness which may impair reliable participation in the trial, necessitate the use of medication not allowed by protocol or represent a safety risk in the Investigator's opinion- Subjects with history of severe adverse hematological reaction to any drug- Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, GGT value of more than three times the upper limit of the reference range- History of suicide attempt during the last 5 years- Subject with suicidal ideations within the last year or at risk of suicide attempt unless cleared by written confirmation from a psychiatrist and approved by the UCB physician- Ongoing psychiatric disorder other than mild controlled disorder
Intervention: Sertraline
Trial phase: Phase 4
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
Eligibility criteria:
Inclusion Criteria:

Current episode (i.e., in the preceding month) of alcohol dependence defined by Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) criteria
18-65 years of age
Abstinent from alcohol for a period of at least 3 days prior to baseline research assessment
Able to read English and complete study evaluations
Male, or if female, without active reproductive potential
Participants will have signed informed consent

Exclusion Criteria:

Currently meets criteria for dependence on a psychoactive substance other than alcohol and nicotine
Regular use of psychoactive drugs including anxiolytics and antidepressants
Current use of disulfiram or naltrexone
Current major depression or psychosis (or other severe psychiatric disability e.g., suicidality, current mania)
Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac pathology, which in the opinion of the evaluating physician would preclude the patient from study adherence or be of potential harm to the subject
Intervention: Atomoxetine
Trial phase: Phase 2
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Individuals in this arm received 40 milligram twice a day atomoxetine.
Eligibility criteria:
Inclusion Criteria:

Confirmed Huntington's disease (HD) diagnosis
Age 18 to 65
Must have mild HD
Must have complaints of poor attention

Exclusion Criteria:

Childhood history of attention deficit hyperactivity disorder (ADHD) symptoms
Diagnosis of schizophrenia, bipolar affective disorder, dementia, delirium or severe anxiety
Current use of a monoamine oxidase inhibitor (MAOI) medication
Pregnancy
Uncontrolled hypertension
Tachycardia
Cardiovascular or cerebrovascular disease
History of a loss of consciousness for greater than (or equal to) 5 minutes
Having any neurological disorder or insult other than Huntington disease