anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Modafinil
Trial phase: Phase 2
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: 400mg Modafinil

Modafinil: 400mg Modafinil
Eligibility criteria:
Inclusion Criteria:

Seeking treatment for cocaine dependence
Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID interview
If female, willing to use effective contraception throughout the study
Lives within 50 miles of the research center and has reliable transportation

Exclusion criteria:

Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than cocaine, alcohol, nicotine, or marijuana
Physiologic dependence on alcohol requiring medical detoxification, on either an inpatient or outpatient basis
Current psychiatric disorder, including depression, schizophrenia, bipolar affective disorder, organic brain disease, dementia, or other types of psychosis
Recent suicidal or homicidal attempts within 60 days of study entry
Suicidal or homicidal ideation within 30 days of study entry
Meets diagnosis criteria from the Differential Diagnosis of Psychotic Disorders section of Mini-SCID for a history of psychotic symptoms during a period of cocaine use (e.g., persistent hallucinations and delusions)
Serious medical illness, including left ventricular hypertrophy, mitral valve prolapse, left bundle branch block, heart attack, angina, serious liver disease (transaminase levels four times greater than normal), and kidney, neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders
Required by the court to obtain treatment for cocaine dependence
Not seeking treatment for cocaine dependence
Participated in cocaine treatment (clinical or research) within 30 days of study entry
Anticipating elective surgery or hospitalization within 20 weeks of study entry
Known or suspected hypersensitivity to modafinil
Use of any of the following medications within 14 days of study entry: selective serotonin reuptake inhibitor antidepressants, tricyclic antidepressants, dopamine agonists, and other psychotropic medications, including anticonvulsants, antipsychotics, anxiolytics, or psychostimulants
Currently taking medications that could adversely interact with study medications, including azole-type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine
Currently taking any medications that induce or inhibit CYP3A4 metabolic pathways
Pregnant or breastfeeding
Intervention: Stalevo
Trial phase: Phase 4
SMILES: CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.CCN(CC)C(=O)C(C#N)=Cc1cc(O)c(O)c([N+](=O)[O-])c1.NC(Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 180
Group description: Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Eligibility criteria:
Inclusion Criteria:

Males or females 30-80 years of age (inclusive). Patients aged 81-85 years were eligible to participate if the principal investigator considered the patient to be in otherwise good health.
Clinical diagnosis of Parkinson's disease exhibiting two of three symptoms (rigidity, resting tremor, bradykinesia).
All patients were required to have end-of dose wearing off (EODWO, re-emergence of PD symptoms at the end of at least two daily doses of levodopa during waking hours).
Taking regular doses of immediate release carbidopa/levodopa

Exclusion Criteria:

Unstable Parkinson's Disease requiring booster doses or treatment with as needed dose regimens of levodopa
Female subjects who are pregnant, trying to become pregnant or nursing an infant

Other protocol-defined inclusion/exclusion criteria applied to this study.
Intervention: Stalevo
Trial phase: Phase 4
SMILES: CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.CCN(CC)C(=O)C(C#N)=Cc1cc(O)c(O)c([N+](=O)[O-])c1.NC(Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 179
Group description: Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Eligibility criteria:
Inclusion Criteria:

Males or females 30-80 years of age (inclusive). Patients aged 81-85 years were eligible to participate if the principal investigator considered the patient to be in otherwise good health.
Clinical diagnosis of Parkinson's disease exhibiting two of three symptoms (rigidity, resting tremor, bradykinesia).
All patients were required to have end-of dose wearing off (EODWO, re-emergence of PD symptoms at the end of at least two daily doses of levodopa during waking hours).
Taking regular doses of immediate release carbidopa/levodopa

Exclusion Criteria:

Unstable Parkinson's Disease requiring booster doses or treatment with as needed dose regimens of levodopa
Female subjects who are pregnant, trying to become pregnant or nursing an infant

Other protocol-defined inclusion/exclusion criteria applied to this study.
Intervention: Aripiprazole
Trial phase: Phase 4
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: aripiprazole augmentation treatment
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients between the ages of 18 and 70.
Patients with a principal Diagnostic and Statistical Manual fourth edition (DSM-IV) diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type
Patients with a total of 14 or higher on the 17-item Hamilton Depression Scale at baseline
Patients who have had treatment with an SSRI at an adequate dose (see Table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in Table 2)
Patients who agree to use acceptable method of birth control throughout the study

Exclusion Criteria:

Patients with any of the following DSM-IV diagnoses: Delirium, Dementia, Amnestic, or other Cognitive Disorders. Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder, Anorexia Nervosa, or Bulimia.
Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol.
Patients who are pregnant or nursing women.
Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening
Patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90), cardiovascular disease, diabetes, HIV (by report of patient).
Patients with a history of seizures.
Intervention: Gabapentin
Trial phase: Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 350
Group description: Double blind, placebo controlled

Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days
Eligibility criteria:
Inclusion Criteria:

Male or female ≥65 years of age undergoing surgery involving the spine, hip or knee replacement.
English speaking.
Anticipated to stay in the hospital for at least 48 hours.

Exclusion Criteria:

Patients who take gabapentin preoperatively, or have known sensitivity to the drug, or those unable to be randomized to receive gabapentin.
Subjects who are unable to provide informed consent.
Patients with a history of narcotic tolerance.
Patients with planned two stage spinal procedures (anterior-posterior spinal fusion to be done on two separate days).
Intervention: Gabapentin
Trial phase: Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 347
Group description: Double blind

Gabapentin: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days
Eligibility criteria:
Inclusion Criteria:

Male or female ≥65 years of age undergoing surgery involving the spine, hip or knee replacement.
English speaking.
Anticipated to stay in the hospital for at least 48 hours.

Exclusion Criteria:

Patients who take gabapentin preoperatively, or have known sensitivity to the drug, or those unable to be randomized to receive gabapentin.
Subjects who are unable to provide informed consent.
Patients with a history of narcotic tolerance.
Patients with planned two stage spinal procedures (anterior-posterior spinal fusion to be done on two separate days).
Intervention: Risperidone
Trial phase: Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Subjects only taking Risperidone.
Eligibility criteria:
Inclusion Criteria:

Male or female patients, 3-7 years 11 months of age.
Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) bipolar disorder and must currently display an acute manic, hypomanic or mixed episode as determined by DSM-IV criteria. This includes the following diagnoses: 296.4x, Bipolar I Disorder, Most Recent Episode Manic; 296.6x, Bipolar I Disorder, Most recent Episode Mixed; and 296.0x, Bipolar I Disorder, Single Manic Episode, Bipolar II Disorder, Most Recent Episode Hypomanic.
Patients must have an initial score (at day 0) on the YMRS total score of at least 20.
Subjects and their caretakers should be fluent in English.

Exclusion Criteria:

Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
Neurologic disorders including epilepsy, stroke, or severe head trauma.
Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis, thyroid indices (T3, Total T4, Free T4, TSH), and EKG.
Mania due to a general medical condition or substance-induced mania (DSM-IV).
Mental retardation (IQ <70), evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder.
History of hypersensitivity to or intolerance of risperidone or valproate.
Prior history of risperidone or valproate non-response.
Judged clinically to be at serious suicidal risk.
Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry.

Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.

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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
Healthy volunteers: No
Participants at risk: 73
Group description: Esomeprazole 40 mg QD
Eligibility criteria:
Inclusion criteria:

A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point categorical scale), which has been present at least 3 times per week for 12 weeks, unrelated to exercise.

C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea; however, the dominant symptom must be epigastric pain/discomfort.

D. Capable of and willing to give informed consent and comply with all study requirements.

Exclusion criteria:

A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C. Patients requiring chronic treatment with any medication inducing GI symptoms (e.g., certain antibiotics, codeine, etc.).

D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions. G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria.

I. History or presence of other known organic disease that might explain the dyspepsia symptoms (e.g., symptomatic gallstones).

J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of beer or 16 fluid ounces of wine) per day.

M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors (PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks maximum).
Intervention: Citicoline
Trial phase: Phase 3
ATC code: N06BX06
SMILES: C[N+](C)(C)CCOP(=O)([O-])OP(=O)(O)OC[C@H]1O[C@@H](n2ccc(N)nc2=O)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Eligibility criteria:
Inclusion Criteria:

Men and women ages 18-70 years
History of mania or hypomania (bipolar I,II, not otherwise specified (NOS) or cyclothymic disorder or schizoaffective disorder/bipolar type)
Early recovery for cocaine abuse/dependence (between 7 days and 12 weeks of enrollment).
Any current mood state as indicated by structured diagnostic interview
No psychotropic medication changes within 7 days prior to enrollment.
English or Spanish speaking

Exclusion Criteria:

Pregnant/nursing woman
Current or past citicoline therapy
Active suicidal or homicidal ideation with plan and intent
Dementia, mental retardation or other severe cognitive impairment
Severe or life threatening medical condition
Intervention: Aripiprazole
Trial phase: Phase 4
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
Eligibility criteria:
Inclusion Criteria:

diagnosis of bipolar disorder I or II according to M.I.N.I.
patient has signed informed consent
male, or female who is using effective birth control if of child bearing age
age 18 and above
currently in a depressed phase, with or without psychotic features, of the illness based on DSM-IV/MINI criteria
score of more than 19 on the MADRS
history of treatment refractory bipolar depression as defined by failure of the depressive episode to respond to a mood stabilizer alone or a combination of 2 or more mood stabilizers or a combination of a mood stabilizer and an antidepressant

Exclusion Criteria:

current liver disease,
illness precluding the use of depakote er
patients who have been treated with a DEP and AZP combination in the past
Alcohol/drug dependence in the past one month
CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
thyroid dysfunction
unstable general medical condition
require antipsychotic other than abilify
Intervention: Oxybutynin
Trial phase: Phase 4
ATC code: G04BD04
SMILES: CCN(CC)CC#CCOC(=O)C(O)(c1ccccc1)C1CCCCC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 39
Group description: Oxybutynin Transdermal System
Eligibility criteria:
Inclusion Criteria:

Pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition;
Use clean intermittent catheterization
On stable dose of oral oxybutynin before participation

Exclusion Criteria:

Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
Have any medical condition that precludes their participation in the study or may confound the outcome of the study
Intervention: Silodosin
Trial phase: Phase 3
ATC code: G04CA04
SMILES: C[C@H](Cc1cc2c(c(C(N)=O)c1)N(CCCO)CC2)NCCOc1ccccc1OCC(F)(F)F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 233
Group description: Silodosin 8 mg once daily with food
Eligibility criteria:
Inclusion Criteria:

Males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia.

Exclusion Criteria:

Medical conditions that would confound the efficacy evaluation.
Medical conditions in which it would be unsafe to use an alpha-blocker.
The use of concomitant drugs that would confound the efficacy evaluation.
The use of concomitant drugs that would be unsafe with this alpha-blocker.
Intervention: Silodosin
Trial phase: Phase 3
ATC code: G04CA04
SMILES: C[C@H](Cc1cc2c(c(C(N)=O)c1)N(CCCO)CC2)NCCOc1ccccc1OCC(F)(F)F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 233
Group description: Silodosin 8 mg once daily with food
Eligibility criteria:
Inclusion Criteria:

Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH.

Exclusion Criteria:

Medical conditions that would confound the efficacy evaluation.
Medical conditions in which it would be unsafe to use an alpha-blocker.
The use of concomitant drugs that would confound the efficacy evaluation.
The use of concomitant drugs that would be unsafe with this alpha-blocker.
Intervention: MYCOPHENOLATE MOFETIL
Trial phase: Phase 2
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
Eligibility criteria:
Inclusion Criteria:

Prior allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells, or cord blood
De novo acute GVHD diagnosed within 48 hours prior to enrollment; biopsy confirmation of GVHD is strongly recommended but not required; enrollment should not be delayed awaiting biopsy or pathology results; the patient must have had no previous systemic immune suppressive therapy given for treatment of acute GVHD except for a maximum 48 hours of prior corticosteroid therapy (at least 1 mg/kg/day methylprednisolone)
Patients that have undergone a scheduled donor lymphocyte infusion (DLI) as part of their original transplant therapy plan
Absolute neutrophil count (ANC) greater than 500/µL
Clinical status at enrollment to allow tapering of steroids to not less than 1 mg/kg/day methylprednisolone (1.4 mg/kg/day prednisone) at Day 28 of therapy (e.g., persisting malignant disease suggesting the need for accelerated taper of immunosuppression)
Estimated creatinine clearance greater than 30 mL/minute
Assent and educational materials provided to, and reviewed with, patients under the age of 18

Exclusion Criteria:

ONTAK, pentostatin, or etanercept given within 7 days of enrollment
Active uncontrolled infection
Patients that have undergone an unscheduled DLI, or DLI that was not part of their original transplant therapy plan
If any prior steroid therapy (for indication other than GVHD), treatment at doses of at least 0.5 mg/kg/day methylprednisolone within 7 days prior to onset of GVHD
Patients unlikely to be available at the transplant center on Day 28 and 56 of therapy
A clinical syndrome resembling de novo chronic GVHD developing at any time after allotransplantation (see Chapter 2 of the BMT CTN Manual of Procedures for details of de novo chronic GVHD)
Other investigational therapeutics for GVHD within 30 days, including agents used for GVHD prophylaxis
Patients who are pregnant, breast feeding, or if sexually active, unwilling to use effective birth control for the duration of the study
Adults unable to provide informed consent
Patients with a history of intolerance to any of the study drugs