anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bupropion Hydrochloride
Trial phase: Phase 4
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 32
Group description: 150 mg bid bupropion SR

Bupropion SR: 150 encapsulated pill, 3 days 1x/day then 56 days at 2x/day, then 3 day at 1x/day ramp-down.
Eligibility criteria:
Inclusion Criteria:Inclusion Criteria:

Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) diagnosis of nicotine dependence with psychological dependence
Smokes at least 10 cigarettes per day for the three months prior to enrollment
Currently seeking treatment for nicotine dependence
Medically healthy on the basis of physical examination and medical history, vital signs,
Females must use an effective method of contraception for the duration of the study

Exclusion Criteria:

DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment
History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
Currently seeking treatment for nicotine disorders
History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
History of significant recent violent behavior
Blood pressure greater than 150/90
History of eating disorders
History of allergic reaction to any of the study medications
Pregnant
Intervention: MYCOPHENOLIC ACID
Trial phase: Phase 2
ATC code: L04AA06
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy

Mycophenolic Acid: Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months
Eligibility criteria:
Inclusion Criteria:

Male or female subjects 18-75 years of age.
Subjects who are recipients of HLA-identical living donor renal allografts from a sibling and are at least 1 year post transplant, their donors and mothers.
Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.

Exclusion Criteria:

GFR <40ml/min;
diagnosis of SLE,
Subjects with proteinuria (defined as a protein:creatinine ratio of >1 or an amount less than this deemed significant on an individual subject basis by the principal investigator),,
multi-organ transplant;
known hypersensitivity to, Prograf, Neoral, CellCept or Myfortic;
history of documented post transplant non-compliance with medications, transplant clinic or laboratory follow-up;
therapy with an investigational immunosuppressive drug within 6 weeks of study entry;
history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;
patients on less than 500 mg PO BID of CellCept or 360 mg PO BID of Myfortic at the time of potential randomization,
history of humoral rejection post transplant,
maintenance or for cause treatment with steroids (prednisone) within 3 months of enrollment.
Intervention: Chlordiazepoxide
Trial phase: Phase 2
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: 1400 mg placebo tablet twice a day for 6 months.

Placebo: none to report
Eligibility criteria:
Inclusion Criteria:

Proven diagnosis of sickle cell disease, either homozygous sickle disease or Hb S Beta zero thalassemia genotype
Age at entry at least 14 years. Younger children will not be included since the combination alpha-lipoic acid and acetyl-L-carnitine tablets are not available in a smaller dose at this time.

Exclusion Criteria:

More than 3 packed red blood transfusions in the past 12 months
Coexisting illness that could contribute to inflammation. These include chronic hepatitis, lupus, arthritis, inflammatory bowel disease, chronic osteomyelitis, and other similar conditions.
Acute sickle cell disease related symptoms requiring a hospital visit in the past 4 weeks
Women who are pregnant, attempting to get pregnant, or breast feeding
Active participation in other investigational drug or device studies
Participants who start hydroxyurea or regular transfusion therapy during the course of the study on the recommendation of their primary hematologist will be ineligible for further participation.
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: Intraoperative administration for analgesia.

Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
Eligibility criteria:
Inclusion Criteria:

Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria:

Children less than 3 years
Children with uncorrected cardiac lesions
Children with heart block or liver impairment
Children with American Society of Anesthesiology Class 3 or 4.
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia

Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia
Eligibility criteria:
Inclusion Criteria:

Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria:

Children less than 3 years
Children with uncorrected cardiac lesions
Children with heart block or liver impairment
Children with American Society of Anesthesiology Class 3 or 4.
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 158
Group description: Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
Voluntarily hospitalized for current manic episode
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
Voluntarily hospitalized for current manic episode
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 169
Group description: Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
Voluntarily hospitalized for current manic episode
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 402
Group description: Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.
Eligibility criteria:
Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures.
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.
Intervention: Sildenafil
Trial phase: Not Applicable
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Sildenafil: oral, 25mg, daily for 1 week
Eligibility criteria:
Inclusion Criteria:

1. Age 20-35 yrs, and 60-80 yrs.
2. Ability to sign consent form (score >23 on the 30-item Mini Mental State Examination, MMSE)
3. Stable body weight for at least 3 months

Exclusion Criteria:

1. Physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (>2/year) or significant weight loss in the past year)
2. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
3. Pregnancy
4. Significant heart, liver, kidney, blood or respiratory disease
5. Peripheral vascular disease
6. Diabetes mellitus or other untreated endocrine disease
7. Active cancer
8. Use of nitrates
9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
10. Alcohol or drug abuse
11. Severe depression (>5 on the 15-item Geriatric Depression Scale, GDS)
12. Cardiac abnormalities such as a cardiac shunt or previously diagnosed pulmonary hypertension.
13. Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90.
Intervention: Sildenafil
Trial phase: Phase 4
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.

Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil
Eligibility criteria:
Inclusion Criteria:

Severe aortic stenosis (AVA < 1.0 cm2)
Referred for a clinically ordered right and left heart catheterization
18 years of age and older
Able and willing to comply with all requirements of the study

Exclusion Criteria:

Nitrate use within 24 hours
SBP < 110 mmHg or MAP < 75 mmHg
Severe mitral regurgitation
Severe aortic regurgitation
Increased risk of priapism
Retinal or optic nerve problems or unexplained visual disturbance
Alpha antagonists or cytochrome P450 3A4 inhibitors use within 24 hours
Current or recent (≤ 30 days) acute coronary syndrome
O2 sat < 90% on room air
Females that are pregnant or believe they may be pregnant
Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable hemodynamic data
Unwilling to provide informed consent
Intervention: Nelfinavir
Trial phase: Phase 2
ATC code: J05AE04
SMILES: [H][C@@]12CCCC[C@]1([H])CN(C[C@@H](O)[C@H](CSc1ccccc1)NC(=O)c1cccc(O)c1C)[C@H](C(=O)NC(C)(C)C)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 1250 mg Nelfinavir twice daily Monday-Sunday

Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday
Eligibility criteria:
Inclusion Criteria:

Histological diagnosis of adenoid cystic carcinoma.
Cancer should be staged recurrent or end-stage with/without metastases who have failed all other therapy.
Age ≥ 18 years
ECOG performance status 0-2 (Karnofsky ≥ 50%, see Appendix A).

Patients must have normal organ and marrow function as defined below:

leukocytes ≥ 3,000/mm3
absolute neutrophil count ≥ 1,500/mm3
platelets ≥ 100,000/mm3
total bilirubin < 1.5 mg/dl OR a stable or a decreasing bilirubin in patients who have undergone placement of an intrabiliary stent
AST(SGOT) ≤ 2.5 X institutional upper limit of normal
ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
No known HIV infection. Since NFV is used in HIV patients, we do not want to interfere with the therapy the patient may already be on.
Not pregnant. The effects of NFV on the developing human fetus have been studied in HIV positive women (21). We do not, however, know the risks along with radiation. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

History of allergic reactions attributed to compounds of similar chemical or biologic composition to NFV.
Uncontrolled diabetes.
Hemophilia A & B as increased bleeding during protease inhibitor therapy has been reported (22).
Patients may not be receiving any other investigational agents. concomitant medications counterindicated for use with nelfinavir
Pregnant or lactating women: The effects of NFV on the developing human fetus have been studied in HIV positive women (21). In addition, the chemotherapy will be deleterious to the fetus.
HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with NFV.
Intervention: Bisoprolol
Trial phase: Phase 4
ATC code: C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05
SMILES: CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
Eligibility criteria:
Inclusion Criteria:

Age of 20 years or older and less than 80 years
Subjects with T2DM
Subjects who have failed to achieve an appropriate BP level as a result of treatment with any antihypertensive drug other than beta blockers - that is, with BP inadequately controlled to greater than or equal to (>=) 130/80 mmHg. However, those who have used a beta blocker before 12 weeks can be enrolled
Subjects who underwent stable anti-diabetic regimen during the 12 weeks prior to screening
Signed written informed consent

Exclusion Criteria:

Ongoing insulin therapy
Change in two HbA1c levels measured at an interval of 4 weeks or longer for the previous 6 months is at least 1% (the last HbA1c is measured within 4 weeks)
Secondary hypertension
Subjects with renal impairment (creatinine greater than 150 micromol per liter or 1.7 milligram per deciliter)
Cardiovascular disease (uncontrolled or symptomatic arrhythmia, unstable angina, sick sinus syndrome, second or third degree atrioventricular (AV) block, bradycardia [less than 50 beats per minute], congestive heart failure, myocardial infarction, cerebral infraction attached within 12 weeks)
Subjects requiring BP control by at least 3 different antihypertensive drugs, or with either systolic blood pressure (SBP) >=180 mmHg or diastolic blood pressure (DBP) >=110 mmHg at baseline
Subjects with type 1 diabetes mellitus (T1DM)
Uncontrolled diabetes with HbA1c >9%
BMI >40 kilogram per square meter (kg/m^2)
Pulmonary disease (chronic obstructive pulmonary disease [COPD], bronchial asthma)
Other patients considered by the investigator to be not eligible for participation in this study for a legal or mental reason
Contraindications for beta-blocker
Pregnant or lactating women
Use of an investigational drug within 30 days of entry to the study
Intervention: Quetiapine Fumarate
Trial phase: Not Applicable
SMILES: O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
Eligibility criteria:
Inclusion Criteria:

Provision of written informed consent
Fluency in English
A diagnosis of GAD
No pregnancy
Right-handedness
Psychotropic medication-free at the start of the study

Exclusion Criteria:

Pregnancy or lactation
Any current DSM-IV-TR Axis I disorder
Any mental retardation or cognitive impairment that precludes informed consent
Known intolerance or lack of response to quetiapine fumarate
Substance or alcohol dependence at enrollment
Participation in another drug trial within 4 weeks prior enrollment
History of allergic reaction or hypersensitivity to Seroquel or Seroquel XR
History of prior Seroquel or other antipsychotic agents use
Contraindications to magnetic resonance imaging
Treatment with an effective medication for GAD
Intervention: Cycloserine
Trial phase: Not Applicable
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.

Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
Eligibility criteria:
Inclusion Criteria:

Eligible subjects must be cocaine-dependent persons between 18 and 65 years

Exclusion Criteria:

Any current Axis-I psychiatric diagnosis other than cocaine or alcohol dependence or nicotine use
Any current or prior neurological disease, history of a major medical illness, or current use of psychotropic medications
Positive history of loss of consciousness of greater than 10 min
Significant current or prior cardiovascular disease (hypertension, arrhythmias) that is not medically stable
History of hospitalization within the previous six months for a medical illness
Deafness, blindness or other significant sensory impairment.
Contraindications for D-cycloserine and magnetic resonance imaging.
Intervention: Dexmedetomidine
Trial phase: Phase 2 | Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr

Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine.
Eligibility criteria:
Inclusion Criteria:

Subjects with a diagnosis of pulmonary hypertension
Procedure - Planned cardiac catheterization procedure with spontaneous ventilation and natural airway
Patients who want sedation or general anesthetic for the procedure.
Age: Subjects ≥8 years and < 21 years
Adequate Renal Function defined As:Serum creatinine ≤ 1 mg/dL
Adequate Liver Function defined As:Total bilirubin ≤ 1.5 mg/dL alanine aminotransferase (ALT) ≤ 2 times the upper limit of normal
Informed Consent: All parents or legal guardians must sign a written informed consent.
Signed assent when developmentally appropriate
Negative pregnancy test in menstruating females and all females ≥ 12 yr

Exclusion Criteria:

Refusal of Informed Consent/Assent
Subjects with single ventricle physiology
Pregnant or lactating females
Subjects with syndromes e.g. Trisomy 21 will be excluded due to variability in pharmacodynamic responses and airway instability during sedation
Inappropriate clinical or developmental status to undergo cardiac catheterization under conditions of spontaneous ventilation with a natural airway
Second or third degree heart block
Moderate - severe right ventricular dysfunction/failure
Subjects who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study e.g. behavioral or anxiety disorders, inability to lie supine
Concomitant Medications - Investigational Drugs: Subjects who have received another investigational drug protocol 30 days prior to enrollment in this study
Subjects who in the opinion of the investigator may be non compliant with study schedules or procedures.
Non-English speaking subjects will be excluded due to need for direct communication from clinical and study staff during study procedures and the ability to complete study tools.