anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Febuxostat
Trial phase: Phase 2
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
Eligibility criteria:
Inclusion Criteria:

Has hyperuricosuria, defined as a daily urine uric acid excretion greater than 700 mg as measured by 24-hour urine collection prior to randomization.
Has at least one calcium oxalate stone greater than or equal to 3 mm in its longest in-plane diameter, identified by Multiple Detector Computated Tomography prior to randomization.
Has a recent (within the previous 5 years) history of renal stones prior to screening.

Exclusion Criteria:

Has gout, secondary hyperuricemia or has experienced a gout flare.
Has a history of xanthinuria.
Has received allopurinol or probenecid within 2 years prior to randomization.
Has received febuxostat.
Has alanine aminotransferase and/or aspartate aminotransferase values greater than 2.0 times the upper limit of normal at the Screening Visit.
Has an abnormal serum calcium level at the Screening Visit.
Has a significant medical condition and/or conditions that would interfere with the treatment, safety or compliance with the protocol according to the judgment of the Investigator.
Has a history of drug abuse or a history of alcohol abuse within 5 years prior to the Screening Visit.
Participant's measured creatinine clearance is less than 30 mL/min at the Screening Visit.

Has hypercalciuria at Screening, while on a regular unrestricted diet, defined as urinary excretion of:

greater than 250 mg of calcium/24-hour for females of body weight less than 62.5 kg; OR
greater than 300 mg calcium/24-hour for males of body weight less than 75 kg; OR
greater than 4 mg calcium/kg/24-hour for males of body weight greater than or equal 75 kg and females of body weight greater than or equal 62.5 kg.

EXCLUDED MEDICATIONS:

Febuxostat, allopurinol, probenecid.
Salicylates (chronic use of aspirin ≤325 mg/day is allowed).
Azathioprine.
Mercaptopurine.
Theophylline.
Colchicine.
Pyrazinamide.
Sulfamethoxazole/trimethoprim.
Losartan.

The following restrictions also apply during the study:

Long-term use (more than 4 continuous weeks) of prescription or over-the-counter nonsterioidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors.
If receiving diuretics, participant must have been on a stable dose for at least 30 days prior to screening. No changes in dosage are allowed during the study.
Intervention: Naltrexone
Trial phase: Not Applicable
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.

Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Eligibility criteria:
Inclusion Criteria:

HIV+
Inmates returning to New Haven or Hartford
Meets criteria for alcohol dependence (using Diagnostic and Statistical Manual IV) or problem drinking (using Alcohol Use Disorder Identification Test-AUDIT)
Gives informed consent
English or Spanish speaker
> 18 yrs

Exclusion Criteria:

On opiate pain medication or expressing need for them
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > 5x the upper limit of normal
Evidence of Child's Pugh Class C cirrhosis
Pending felony charges
Pregnant or unwilling to take contraceptive measures
Subject is part of another pharmacological research study
Intervention: Nilotinib
Trial phase: Phase 1
ATC code: L01EA03 | L01XE08
SMILES: Cc1cn(-c2cc(NC(=O)c3ccc(C)c(Nc4nccc(-c5cccnc5)n4)c3)cc(C(F)(F)F)c2)cn1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: >= 10 years to <18 years pediatric patients
Eligibility criteria:
Inclusion Criteria:

Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/ intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or refractory to standard therapy
adequate renal, hepatic and pancreatic function

Exclusion Criteria:

patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and treatments cannot be stopped or changed to a different medication at least 14 days prior to starting study drug
patients receiving therapy with any medications with a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
gastrointestinal impairment or disease that may interfere with drug absorption
liver, pancreatic or severe renal disease unrelated to disease under study
impaired cardiac function
patients who received dasatinib within 3 days of starting study drug
patients who received imatinib within 5 days of starting study drug
patients receiving hydroxyurea or corticosteroids that has not been discontinued at least 1 week after initiation of nilotinib
patients who received hematopoietic growth factors within 7 days of starting study drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drug
patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active graft vs. host disease and < 3 months since SCT

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Propranolol
Trial phase: Phase 2
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Propranolol: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
Eligibility criteria:
Inclusion Criteria:

Diagnosis by electrophoresis (HEP) of Hemoglobin (Hgb) SS or Hgb Sβ0 thalassemia (all patients followed at our clinic have HEP-confirmed diagnosis on file)
Age ≥ 18 years
Blood pressure (BP) Systolic ≥ 95mm Hg and Diastolic ≥ 50mm Hg
Heart rate (HR) ≥ 70 and ≤ 110 bpm
Oxygen saturation by pulse oximeter and at room air ≥ 92%
Hematocrit (Hct) ≥ 20% and Hb > 6.0 g/dL
Euthyroid status as indicated by normal Thyroid Stimulating Hormone (TSH)
SS RBCs obtained during screening period demonstrating an adhesion response to epinephrine of 40% over non-stimulated baseline adhesion to endothelial cells
Capacity to understand and sign informed consent

Exclusion Criteria:

History of vaso-occlusive episode during the 6 wks prior to screening
RBC transfusion during the 3 months prior to study entry
Ongoing pregnancy
History of heart failure, myocardial infarct (MI), bradyarrhythmias, conduction defects
History of asthma or reactive airway disease
History of thyroid disease
Diabetes
Renal insufficiency (BUN >21 mg/dL and/or Creatinine >1.4 mg/dL)
Use during the screening or study period of any of the following medications: antihypertensives, diuretics, thyroid replacement therapy, anti-arrhythmia medications, bronchodilators, inhaled steroids, insulin, or hypoglycemic medication
History of allergy to sulfonamides
Intervention: Ramipril
Trial phase: Not Applicable
ATC code: C09AA05 | C09BA05 | C09BB05 | C09BB07 | C09BX03 | C09BX05 | C10BX04 | C10BX06 | C10BX17 | C10BX18
SMILES: [H][C@@]12CCC[C@]1([H])N(C(=O)[C@H](C)N[C@@H](CCc1ccccc1)C(=O)OCC)[C@H](C(=O)O)C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.

ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control.
Eligibility criteria:
Inclusion Criteria:

Heart transplant recipient within the first month of transplant;
12 years of age or older;
Must have a serum creatinine less than 2.0 mg/dl;
Will provide written informed consent;
Female patients of childbearing potential must have negative pregnancy test;
For pediatric patient, parent(s) will provide consent and the child will sign assent.

Exclusion Criteria:

Less than 12 years of age;
Have more than one solid organ transplant at time of heart transplant;
Has serum creatinine greater than 2.0 mg/dl;
Pregnancy.
Intervention: Desmopressin
Trial phase: Phase 3
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 45
Group description: During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
Eligibility criteria:
Inclusion Criteria:

Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality
Age 6 or above but under 16 regardless of gender
Out-patient
Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week
Deemed healthy by the investigator
Able to agree to and comply with fluid-intake restriction during the clinical trial and matters specified in the clinical trial protocol
Consent from the pediatric patient's legally acceptable representative
Demonstrate an understanding about this clinical trial after receiving an explanation corresponding to the prospective subject's intelligibility
Show no possibility of being a nursing mother or pregnant, or becoming pregnant
If under drug or medical therapy other than Desmopressin for treating nocturnal enuresis: able to discontinue such treatment

Exclusion Criteria:

Suffer from enuresis with an underlying disease
Participated in another clinical trial within six months preceding consent
Used an intranasal Desmopressin in the past
Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic or a drug that affects urinary concentration, or a drug or medical therapy for overactive bladder
Have an anomaly or a disease that may affect the oral absorption of drug products
Hard to get cooperation from subject by school refusal, punishment or bullying
Deemed by the investigator to be inappropriate to participate in this trial
Unable to be placed on water-intake restriction starting from two hours before bedtime
Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
Intervention: Entecavir
Trial phase: Phase 3
ATC code: J05AF10
SMILES: C=C1[C@H](CO)[C@@H](O)C[C@@H]1n1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 120
Group description: Subjects received 0.015 milligram per kilogram per day (mg/kg/day) (up to a maximum dose of 0.5 mg/day) ETV as oral solution or tablets, once daily (QD).
Eligibility criteria:
Key Inclusion Criteria

Males and females, aged 2 to <18 years
Hepatitis B surface antigen-positive
Detectable hepatitis B e (HBe) antigen, and no detectable anti-HBe antibodies
Alanine aminotransferase (ALT) 1.5 to <10 times the upper limit of normal at screening and within 8 to 24 weeks prior to screening
Evidence of the presence of hepatitis B virus DNA at least 4 weeks before screening and >100,000 copies/mL at screening

Key Exclusion Criteria

Any prior therapy with entecavir
At least 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent
Therapy with interferon alpha, thymosin alpha, or nucleototide antiviral agents within 24 weeks of screening
Coinfection with HIV, hepatitis C virus, or hepatitis D virus
Decompensated liver disease
Liver transplant recipients
Other forms of acute and chronic conditions which may cause increased ALT levels
Children who were breastfed while their mothers received lamivudine or whose mothers received lamivudine during pregnancy
Intervention: Phenylephrine
Trial phase: Not Applicable
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: 100 mcg of phenylephrine is administered at the time of reperfusion
Eligibility criteria:
Inclusion Criteria:

- adults scheduled to undergo liver transplantation

Exclusion Criteria:

- pediatric liver transplantation
Intervention: Epinephrine
Trial phase: Not Applicable
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: 10 mcg of epinephrine is administered iv at the time of reperfusion
Eligibility criteria:
Inclusion Criteria:

- adults scheduled to undergo liver transplantation

Exclusion Criteria:

- pediatric liver transplantation
Intervention: Crizotinib
Trial phase: Phase 1
ATC code: L01ED01 | L01XE16
SMILES: C[C@@H](Oc1cc(-c2cnn(C3CCNCC3)c2)cnc1N)c1c(Cl)ccc(F)c1Cl
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
Eligibility criteria:
Inclusion Criteria:

Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug screen.
Intervention: Pravastatin
Trial phase: Phase 4
ATC code: C10AA03 | C10BA03 | C10BA11 | C10BA12 | C10BX02
SMILES: [H][C@@]12C(=C[C@@H](O)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks

Pravastatin: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Eligibility criteria:
Inclusion Criteria:

Male or female
Age 18-68 years
Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
Well established compliance with outpatient medications including their antipsychotic medication

Exclusion Criteria:

Inability to provide informed consent
Current substance and alcohol abuse
Significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine > 1.5), severe hepatic impairment or active liver disease, anemia (hemoglobin <11.0 gm/dL), history of severe head injury, and not treated muscle disease.
Psychiatrically unstable
Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
Subjects treated with anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; agents that induce weight loss, and St. John's Wort will be excluded from the study
Current history of untreated thyroid disease
Current treatment with insulin
Subjects being treated with drugs such as: colchicine, azole antifungals (fluconazole, ketoconazole, itraconazole); macrolide antibiotics (clarithromycin, erythromycin); HIV protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir) that inhibit the CYP 450 3A liver enzyme
Known hypersensitivity to pravastatin or any of its components
Intervention: Febuxostat
Trial phase: Phase 2
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
Eligibility criteria:
Inclusion Criteria:

Must have a serum urate greater than 7 mg/dL and a serum creatinine greater than or equal to 1.5 mg at Day -21
Must have a history or presence of gout defined as having one or more of the American Rheumatism Association criteria for the diagnosis of gout (the criteria related to tophi have been excluded for the purpose of the study)
Must have an estimated Glomerular Filtration Rate (eGFR) of 15 or greater, or less than or equal to 50 mL/min, AND a serum creatinine greater than 1.5 mg/dL at Screening Visit Day -21

Exclusion Criteria:

Has secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ transplant)
Has tophaceous gout
Has a history of xanthinuria
Has received aspirin greater than 325 mg/day within 35 days prior to Day 1/Randomization Visit
Has known hypersensitivity or allergy to allopurinol or any component in its formulation
Has known hypersensitivity to febuxostat or colchicine or any components in their formulation
Has myocardial infarction or stroke within the 90 days prior to the Screening Visit
Has alanine aminotransferase and/or aspartate aminotransferase values greater than 2.0 times the upper limit of normal
Has end stage renal disease or is likely to be a candidate for dialysis over the 1 year study period
Has a serum creatinine less than or equal to 1.5 mg/dL, or an estimated Glomerular Filtration Rate at Day -21 Screening Visit less than 15 mL/min or greater than 50 mL/min as calculated by the central laboratory
Is required to take excluded medications
Intervention: Pyrimethamine
Trial phase: Phase 1 | Phase 2
ATC code: P01BD01 | P01BD51 | P01BF04 | P01BF09
SMILES: CCc1nc(N)nc(N)c1-c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Open label. Only one arm will receive the intervention.

Pyrimethamine: Open Label, dose escalating,
Eligibility criteria:
Inclusion Criteria:

Subjects with definite, probable, or laboratory supported probable ALS will be eligible.

ALS diagnosed as probable, laboratory supported probable or definite according to the World Federation of Neurology El Escorial criteria [Brooks et al. 2000]
Age 18 or older
Capable of providing informed consent and complying with trial procedures
SOD1 mutation confirmation by study team
Not taking Riluzole (Rilutek) or on a stable dose for 30 days
Not taking Coenzyme QR10R or on a stable dose and brand for 30 days
Absence of exclusion criteria

Exclusion Criteria:

History or evidence of malabsorption syndromes
Exposure to any experimental agent within 30 days of onset of this protocol
Women who are pregnant or planning to become pregnant
Women of childbearing potential not practicing contraception
Women who are breastfeeding
Enrollment in another research study within 30 days of or during this trial
Alcoholism
Patients taking phenytoin (Dilantin) or other therapy affecting folate levels
Dementia (MMSE <22)
Seizure disorder
Folate deficiency
Megaloblastic anemia
Cardiovascular disorder/arrhythmia
Impaired kidney function, defined as creatinine levels of 2.5 x ULN
Impaired liver function, defined as AST or ALT of 3 X ULN
Advanced ALS patients, defined as those with any of the following: forced vital capacity <60% (use of BIPAP is allowed); tracheostomy; or mechanical ventilation
Use of any of the following medications: cytosine, arabinoside, methotrexate, daunorubicin, sulfonamides, zidovudine, lorazepam, coumadin, sulfamethoxazole, and trimethoprim
Patients taking Lithium within 30 days of or during this trial
Incapable of providing informed consent and complying with trial procedures
Intervention: Azacitidine
Trial phase: Phase 2
ATC code: L01BC07
SMILES: Nc1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)c(=O)n1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

azacitidine: Given SC or IV

laboratory biomarker analysis: Correlative studies
Eligibility criteria:
Inclusion Criteria:

MDS, CMML or AML patients (as diagnosed by World Health Organization [WHO] criteria) with evidence of relapse or progression at >= day 28 and < day 100 post-transplant
Recurrent or increased cytogenetic abnormalities by standard karyotype or fluorescence in situ hybridization (FISH) (the cytogenetic abnormalities must have been previously documented at some time point between diagnosis and date of stem cell transplant)
Morphologic evidence of recurrence or increased abnormal myeloblasts in peripheral blood or marrow
Flow Cytometric evidence of disease as determined by recurrent or increased abnormal myeloblasts in peripheral blood or marrow
Extramedullary relapse (local radiotherapy will be allowed)
MDS, CMML, or AML patients with persistent stable disease or persistent disease with regression at >= day 28 and < day 100 post-transplant; the inclusion of patients with persistent stable or persistent regressing disease in this protocol is not meant to advocate treatment; however, if the attending physician is inclined to offer treatment then these patients would be eligible for this study
Persistence of cytogenetic abnormalities by standard karyotype or FISH
Persistent morphologic evidence of abnormal myeloblasts (in patients with CMML the monoblastoid population is included) in peripheral blood or marrow
Persistent flow cytometric evidence of abnormal myeloblasts (in patients with CMML the monoblastoid population is included) in peripheral blood or marrow
Extramedullary persistence or regression

Exclusion Criteria:

Refractory disease at time of stem cell transplant; patients who received chemotherapy prior to transplant with no evidence of response by International Working Group (IWG) criteria
>= 10% bone marrow myeloblasts as measured by morphology
Evidence of central nervous system (CNS) disease at time of relapse by morphology or flow (a diagnostic lumbar puncture [LP] is not required at time of relapse)
Serum creatinine > 2 x ULN (upper limit of normal)
Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2x ULN
Performance status > 2 (Eastern Cooperative Oncology Group [ECOG] Scale)
Patients with severe disease other than MDS, CMML or AML which would be expected to prevent compliance with treatment
Patients with severe infections (pneumonia, sepsis, etc) within the 2 weeks prior to the anticipated start of protocol treatment