anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pentostatin
Trial phase: Phase 2
ATC code: L01XX08
SMILES: OCC1OC(n2cnc3c2NC=NCC3O)CC1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
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
Intervention: Atazanavir
Trial phase: Phase 3
ATC code: J05AE08 | J05AR15 | J05AR23
SMILES: COC(=O)N[C@H](C(=O)N[C@@H](Cc1ccccc1)[C@@H](O)CN(Cc1ccc(-c2ccccn2)cc1)NC(=O)[C@@H](NC(=O)OC)C(C)(C)C)C(C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.

Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily.
Eligibility criteria:
Inclusion Criteria:

HIV infection
HIV-1 RNA < 500 copies/ml
Fasting LDL cholesterol >130 mg/dl OR fasting triglycerides >200 mg/dl
CD4 count >100 cells/mm
Stable antiretroviral regimen for at least 12 weeks prior to study entry that includes a protease inhibitor (PI) with or without ritonavir boosting

Exclusion Criteria:

History of heart disease, uncontrolled hypertension, peripheral vascular disease
Current non-nucleoside reverse transcriptase inhibitor (NNRTI) in the PI-containing regimen within 4 weeks
Prior or current use of atazanavir
Initiation of treatment with lipid-lowering drugs within 4 weeks prior to study entry
Intervention: Erbitux
Trial phase: Phase 2
SMILES: C=C1N(CCCCCC(=O)O)c2ccccc2C1(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
Eligibility criteria:
Inclusion Criteria:

Histologic proof of pancreatic adenocarcinoma
Clinical stage I, II, or III disease
Radiographically measurable disease
Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry
Signed protocol consent
Karnofsky performance status of at least 70%
Age > or = to 18 years
Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment.
Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul.
Creatinine < 1.5 x upper limit of normal (ULN)
Bilirubin < 1.5 x ULN; AST < 2.5 x ULN.

Exclusion Criteria:

Acute hepatitis or known HIV
Active or uncontrolled infection
Significant history of cardiac disease
Prior therapy which affects or targets the EGF pathway
Prior severe infusion reaction to a monoclonal antibody
Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents
Any previous chemotherapy or abdominal or pelvic radiotherapy
No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years.
Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study
Intervention: Donepezil
Trial phase: Phase 4
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Donepezil for 12 weeks

Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Admitted to a rehabilitation hospital with primary diagnosis of ischemic stroke (cardiovascular accident)
Stroke was within 30 days of being admitted
Medically stable
Presence of memory and/or attentional impairments and evidence that these impairments were not present or were less severe prior to the stroke (assessed via interview with family)
Approval by individual's attending physician at the rehabilitation hospital

Exclusion Criteria:

Aphasia or cognitive (or behavioral) impairments severe enough to prevent valid neuropsychiatric assessment
Currently experiencing a major depressive episode (unless treated and in partial remission, assessed using the Primary Care Evaluation of Mental Disorders)
Current psychosis or mania
History of substance or alcohol abuse or dependence within three months of study entry
Currently taking a cholinomimetic drug
Medical condition with known sensitivity to donepezil (e.g., slower than normal heart rate, supraventricular cardiac conduction defects, severe asthma or obstructive pulmonary disease, active upper gastrointestinal bleed, or gastric/duodenal ulcer if not on acid-blocking agent)
Informed that taking donepezil is medically inadvisable
Current use of any anticholinergic medication (e.g., for bladder spasm)
Intervention: Kenalog
Trial phase: Not Applicable
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered "treatment failure" and will be given the option to have laser therapy.

Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
Eligibility criteria:
Inclusion Criteria:

visually significant cataracts
pre-operative visual acuity 20/50 or worse
pre-operative optical coherence tomography (OCT) showing at least 250 microns central foveal thickness.

Exclusion Criteria:

macular ischemia
vitreomacular traction
macular hole
Intervention: Eliglustat Tartrate
Trial phase: Phase 4
SMILES: CCCCCCCC(=O)NC(CN1CCCC1)C(O)c1ccc2c(c1)OCCO2.CCCCCCCC(=O)NC(CN1CCCC1)C(O)c1ccc2c(c1)OCCO2.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Mothers with Fabry disease who received commercially available Fabrazyme intravenous infusion at the prescribed dose and regimen as part of the standard of care while lactating/pregnant as determined by their treating physician were enrolled in this study. Infants born to the enrolled mothers with Fabry disease who received Fabrazyme during lactation were also enrolled.
Eligibility criteria:
Inclusion Criteria:

Mothers that met the following criteria were enrolled in this study:

provided signed written informed consent to participate in this study,
be enrolled in the Fabry Registry and received Fabrazyme while lactating,
agreed to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and
agreed to adhere to the schedule of evaluations for this study.

Infants that met the following criteria were enrolled in this study:

had the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study,
born to a mother who was receiving Fabrazyme during lactation,
received breast milk from the mother, and
had the agreement of the parent(s)/legal guardian(s) to adhere to the schedule of evaluations for this study.

Exclusion Criteria:

The mother and infant were excluded from this study if the mother received an investigational drug within 30 days prior to study enrollment.
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Melatonin 0.4 mg
Eligibility criteria:
Inclusion Criteria:

History of insomnia
Low melatonin levels at study entry

Exclusion Criteria:

History of sleep apnea (temporary cessation of breathing during sleep)
Diagnosis of restless legs syndrome
Current alcohol or substance abuse
Dementia
Anemia
Liver disease
Leukemia or lymphoma
Asthma
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Melatonin 4.0 mg
Eligibility criteria:
Inclusion Criteria:

History of insomnia
Low melatonin levels at study entry

Exclusion Criteria:

History of sleep apnea (temporary cessation of breathing during sleep)
Diagnosis of restless legs syndrome
Current alcohol or substance abuse
Dementia
Anemia
Liver disease
Leukemia or lymphoma
Asthma
Intervention: Fluconazole
Trial phase: Not Applicable
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
Eligibility criteria:
Inclusion Criteria:

Patients with hematologic malignancies and non-malignancies who are candidates for matched sibling donor allogeneic bone marrow transplantation are eligible for this study.
Patients who are under 55 years of age.
Patients who have a life expectancy of at least 12 weeks and a performance status of at least 2 Zubrod or 70% Karnofsky status prior to transplantation.
Patients who are acceptable candidates for marrow transplantation based on their pre-BMT evaluation.
Patients who have available histocompatible siblings who have been medically approved as marrow donors.
Patients who sign informed consent for the protocol approved by the Institutional Review Board of Emory University/Children's Healthcare of Atlanta.
Donors must be 5 years of age or older, and have completed routine donor evaluations and signed (by parent or legal guardian) informed consent for the protocol approved by the Institutional Review Board of Emory University/Children's Healthcare of Atlanta.

Exclusion Criteria:

Patients will not be excluded based on sex, racial, or ethnic background.

Patients will be excluded if they demonstrate significant functional deficits in major organs, which would obviously interfere with a successful outcome following bone marrow transplant utilizing the following guidelines:

Evidence of active, deep seated, life-threatening infections for which there is no known effective therapy (e.g. certain fungal species, HIV, etc.).
Patients with hemoglobinopathy (e.g. sickle cell disease and thalassemia) will not be eligible for this protocol. However, filgrastim mobilization, large volume apheresis, processing, and cryopreservation appears to be safe in donors with sickle cell trait.
Patients have had greater than two leukemic episodes, active central nervous system (CNS) and/or leukemic disease and blast crisis in chronic myelogenous leukemia (CML) patients.
Patients will be excluded if they are women of childbearing potential who are currently pregnant (beta-hCG+) or who are not practicing adequate contraception.
Patients who have had previous stem cell transplant will be excluded.
Donors will be excluded if they are sensitive to E. coli-derived protein.
Intervention: Pioglitazone
Trial phase: Phase 4
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: pioglitazone
Eligibility criteria:
Inclusion Criteria:

Patients will be males or females, 18-70 yrs of age, with a diagnosis of schizophrenia or schizoaffective disorder, and currently being treated with olanzapine or clozapine.

Patients will have evidence of:

glucose levels indicating at least impaired fasting glucose: fasting glucose 100 mg/dL or 2 hr glucose tolerance test 140 mg/dL, or current treatment with oral antidiabetic drugs with history of hyperglycemia;
Triglyceride levels > 120 mg/dL and/or HDL levels < 40 mg/dL

Exclusion Criteria:

Diabetes mellitus, type 1
Recent diabetic ketoacidosis;
Patients not currently treated with oral antidiabetic drugs but fasting is glucose 140 mg/dL [WHO criteria] on repeat testing in last three months, or random blood glucose >200 mg/dL plus 2 hr glucose on GTT >200 mg/dL; (these patients may need more immediate treatment with antidiabetic drugs and it is less certain if weight-lifestyle treatment would be effective in treating such high glucose levels);
Patients with active liver disease with clinical abnormalities which need current treatment, or liver enzymes (Alt) 3 times upper limit for normal values in chart records in last year, or patients who are recorded as positive for hepatitis C;
Congestive heart failure (Class III or IV cardiac status) or history of MI in medical record (because pioglitazone can increase blood volume slightly);
Hematocrit greater than 10% below normal (hematocrit may be decreased 2 to 4% due to increased plasma volume);
Female patients on current oral contraceptives (because pioglitazone may interfere with effects of some oral contraceptives);
Patients taking ketoconazole,
Patients who have started on atorvastatin or gemfibrozil in the past 2 months or have had a dose increase in atorvastatin in the last month (since these drugs can also lower triglycerides and raise HDL, recent start of therapy with these drugs could be a confound).
Patients are not concomitantly treated with aripiprazole or ziprasidone.
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: 21
Group description: single dose of 200 mg. a day of modafinil for four weeks
Eligibility criteria:
Inclusion Criteria:

- Individuals who sustained a TBI with a documented loss of consciousness or evidence of a TBI on neuroimaging studies and who are at least 12 months post-injury, who complain of fatigue and who have scores of 22 or above on the Barroso Fatigue Scale will be eligible to participate in this study. Subjects must not meet criteria for alcohol or substance abuse using the Structured Clinical Interview for DSM-IV (SCID) for at least six months prior to study enrollment.

Exclusion Criteria:

- Diagnosis of chronic neurological disease (including Lyme disease), narcolepsy, current infectious disease, chronic fatigue syndrome, fibromyalgia, anemia, hypothyroidism not adequately controlled with medication, blood pressure greater 150/100 mm Hg, or clinically significant major systemic disease. In addition, individuals taking medications which are known to cause fatigue will be excluded from participation in the study.
Intervention: Sertraline
Trial phase: Phase 2
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: 22
Group description: Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
Eligibility criteria:
Inclusion Criteria:

18 years or older
experienced a TBI with a documented loss of consciousness or other evidence of a TBI (i.e., evidence of pathology on neuro-imaging)
at least 6 months post-injury
English-speaking
residential telephone service
living within 1.5 hours of New York City
able to comprehend or answer verbal or written questionnaires
willing to provide consent to participate in a 12 week drug study to treat Major Depressive Disorder (MDD); current MDD as diagnosed using Structured Clinical Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) Disorders (SCID), and severity of MDD rated at least 18 on the HAM-D.

Exclusion Criteria:

currently taking antidepressant medication (including monamine oxidase inhibitors (MOAs) or tricyclic antidepressants (TCAs)
unwilling to abstain from seeking new psychosocial or pharmacologic treatments during the course of the study
currently in psychotherapy
active suicidal plans and/or requiring hospitalization
prior use of sertraline
currently experiencing other serious medical illness
currently pregnant or breast feeding
mass brain lesions or other neurological diagnoses other than TBI
history of current or past psychosis or mania
current substance abuse
history of clinically significant liver or renal disease
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: atorvastatin 10mg QD x 3 months
Eligibility criteria:
Inclusion Criteria:

Age≥18 years old
LVEF ≤ 35%, as documented by echocardiography, radionuclide ventriculography, gated SPECT, or contrast ventriculography within past 6 months
Symptomatic HF (NYHA II-IV) or current NYHA I with history of symptomatic HF within the last year
Stable doses of optimal HF medical therapy, unless documented contraindication.

Exclusion Criteria:

Ischemic etiology of HF, defined as the presence of at least one of the following four criteria; angiographic evidence of > 50% lesion in 1 or more of the 3 major epicardial vessels; history of myocardial infarction; history of revascularization procedure; evidence of significant perfusion defect in the setting of ischemic symptoms.
Clinical indication for statin treatment - coronary artery, cerebrovascular, or peripheral vascular disease
Major cardiovascular event or surgical procedure within past 8 weeks
LDL<70 mg/dL
HF secondary to congenital heart disease or uncorrected valvular disease
Treatment with statin within past 2 months
Pregnancy
Contraindication to statin: moderate liver disease, AST/ALT > 150 U/ L, known hypersensitivity
Likely to receive heart transplant within 3 months
Known peripheral or autonomic neuropathy
Intervention: ASPIRIN
Trial phase: Phase 4
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1335
Group description: Aspirin, oral tablet, 81 mg aspirin
Eligibility criteria:
Inclusion Criteria:

Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
Patients aged 20 to 80 years (inclusive) at time of consent
Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
Patients without asymptomatic cerebral infarction
Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
Patients without severe disturbances/impairments following occurrence of cerebral

Exclusion Criteria:

Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
Pregnant, possibly pregnant, or nursing women
Patients with ischemic heart failure
Patients with peptic ulcer
Patients with severer blood disorders
Patients with severe hepatic or renal
Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
Patients who are being treated with ticlopidine hydrochloride
Patients who are participating in another study for an investigational drug
Patients who are otherwise judged inappropriate for inclusion in the study by the investigators