anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Enalapril
Trial phase: Phase 3
ATC code: C09AA02 | C09BA02 | C09BB02 | C09BB06
SMILES: CCOC(=O)[C@H](CCc1ccccc1)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
Eligibility criteria:
Inclusion Criteria:

BCPC patients at time of routine pre-Fontan catheterization
Patients between the ages of 2 months and 5 years old

Exclusion Criteria:

Patients who have had ACEI therapy within 24 hours of the procedure
Intervention: Growth hormone
Trial phase: Phase 4
SMILES: CC(C)CC1NC(=O)C(CCC(=O)O)NC(=O)C2CSSCC3NC(=O)C(C)NC(=O)C4CCCN4C(=O)C(CC(N)=O)NC(=O)C(CSSCC(NC(=O)C(Cc4ccc(O)cc4)NC(=O)C(CC(N)=O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(N)CC(N)=O)C(=O)N2)NC(=O)C(CSSC(C(=O)NC(Cc2ccc(O)cc2)C(=O)O)NC(=O)CNC(=O)C(C(C)O)NC3=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Group of subjects (n=5) who received treatment
Eligibility criteria:
Inclusion Criteria:

Be male or female between 19 and 78 years of age, inclusive
Have a diagnosis of SBS and 1 or more of the following characteristics:
Dependent upon TPN and/or IV fluids
Unable to receive TPN because of a documented history of complications associated with the long-term parenteral infusions (e.g. lack of venous access, multiple septic events, progressive liver dysfunction while on TPN, etc)
A documented remnant bowel anatomy that is inconsistent with adequately supporting life without parenteral support (e.g. < 70 cm of healthy small intestine and a portion of colon, or less than 150 cm in patients with no colon)
A documented history of diarrhea and/or malabsorption that has significantly compromised the patient's nutritional and hydration status (e.g. significant weight loss - 5% over 1 month or 10% over 6 months, or a serum albumin < 3.5 g/dl, documented nutrient deficiencies, documented episodes of dehydration, etc).
Is able to eat at least some (>500 calories) of solid food on a regular basis or tolerate at least some (>500 calories) of an enteral feeding formula
Have stable liver and renal function
For patients with known hypertension and other cardiovascular disorders, be both compensated and stabilized on a regular therapeutic regimen
For women participating in the study, manifest or give assent to 1 of the following criteria to ensure that the patient does not become pregnant during the study:
The patient must be surgically sterile or demonstrably postmenopausal.
Any patient capable of becoming pregnant must have a negative urine pregnancy test and must agree to practice a method of contraception documented to have at least 90% reliability throughout the treatment period.
Have the ability to understand the requirements of the study, to provide written Informed Consent, and to abide by the study restrictions and agree to complete the required assessments in the Follow-up Period

Exclusion Criteria:

Be pregnant or lactating
Have a history of mental deficiency or illness that might compromise compliance with the requirements of the study
Have clinically serious neurological dysfunction
Have hypoxemic pulmonary diseases (i.e., resting pAO2 < 75 torr)
Have unstable ischemic heart disease or uncompensated cardiac failure
Have participated in any study involving an investigations drug within 30 days prior to entry into this trial.
Intervention: CID 23581946
Trial phase: Phase 3
ATC code: D06BX02
SMILES: CC=C(C)C(=O)OC1C(C)=CC23C(=O)C(C=C(CO)C(O)C12O)C1C(CC3C)C1(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Eligibility criteria:
Inclusion Criteria:

Must be male or female and at least 18 years of age.
Female patients must be of:
Non-childbearing potential;
Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
4 to 8 AK lesions on non-head locations.

Exclusion Criteria:

Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area
Intervention: Rifaximin
Trial phase: Phase 3
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 106
Group description: Rifaximin 600 MG QD
Eligibility criteria:
Inclusion Criteria:

travelling to Mexico within 72 hours of enrollment
read and understand English
in good health

Exclusion Criteria:

acute diarrhea within previous 7 days
taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.
taken antidiarrheal medication within 24 hours of enrollment or anytime during study.
Intervention: Citalopram
Trial phase: Phase 2
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 170
Group description: Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression

Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Eligibility criteria:
Inclusion Criteria:

Hispanic males and females
DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate severity (HAM-D-17> 18)
18- 79
Patients with stable dosage of Benzodiazepines to treat anxiety disorders

Exclusion Criteria:

At risk of attempting suicide
Unstable medical illness
History of bipolar disorder, schizophrenia, or other psychotic disorder
Pregnant or lactating
Alcohol or substance use disorder that requires acute detoxification
Intervention: Mosapride citrate
Trial phase: Phase 3
SMILES: CCOc1cc(N)c(Cl)cc1C(=O)NCC1CN(Cc2ccc(F)cc2)CCO1.O=C(O)CC(O)(CC(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Mosapride

Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Rome III Criteria for IBS:

Patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following:

Relieved by defecation
Onset associated with a change in stool frequency
Onset associated with a change in stool form or appearance

In addition, patients have to experience at least two of the following symptoms for at least 25% of the time [11]:

Altered stool frequency (< 3 bowel movements per week)
Altered stool form (lumpy/hard i.e. Bristol type I-III [see appendix 1])
Altered stool passage (straining, urgency, or a feeling of incomplete evacuation)
Passage of mucus, bloating, or a feeling of abdominal distension

Exclusion Criteria:

Previous allergy to mosapride
Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease)
Age < 18 years
History of bloody stools or melena
Diarrhea (>3 bowel movements per day)
Constitutional symptoms (fever, weight loss)
Severe constipation (< 1 bm/week)
Pregnancy or lactation
Patients with history of cardiac arrhythmias
QT prolongation on baseline ECG
Chronic laxative use and dependence
Patients with previous history of congenital heart disease
Patients with previous history of hypokalemia or hyperkalemia
Patients taking the following classes of drugs: HIV antivirals, macrolides, anti-arrhythmics, and azole drugs.
Intervention: Fenoldopam
Trial phase: Not Applicable
ATC code: C01CA19
SMILES: Oc1ccc(C2CNCCc3c2cc(O)c(O)c3Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.

Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours
Eligibility criteria:
Inclusion Criteria:

Patients who have a solitary kidney and present for a partial nephrectomy
Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney

Exclusion Criteria:

History of current renal disease beyond the diagnosis of renal malignancy
Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty
History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected
A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics
Intervention: Racivir
Trial phase: Phase 2
ATC code: J05AF09 | J05AR03 | J05AR06 | J05AR08 | J05AR09 | J05AR17 | J05AR18 | J05AR19 | J05AR20 | J05AR22
SMILES: Nc1nc(=O)n(C2CSC(CO)O2)cc1F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 50
Group description: Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
Eligibility criteria:
Key Inclusion Criteria:

Complete or have previously completed at least through the Week 96 Visit (i.e., 96 weeks on study) for the FTC-203 study.
Complete all End-of-Study Visit procedures for the FTC-203 study.
Either (a) have a plasma HIV-1 RNA viral load of ≤ 400 copies/mL at the End-of-Study Visit for the FTC-203 study, or (b) if the subject's plasma HIV-1 RNA viral load at the End-of-Study Visit for FTC-203 study is > 400 copies/mL, their viral load is < 1.0 log10 above the nadir recorded after Week 8 of the FTC-203 study and there is reliable genotypic evidence showing a lack of resistance to emtricitabine.
A parent or other legal guardian has provided written informed consent to the subject participating in the rollover protocol. As applicable, based on the subject's age and normal institution practice, the subject should additionally provide their written informed consent or assent to participate in the rollover protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Lesogaberan
Trial phase: Phase 2
SMILES: NC[C@@H](F)C[PH](=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 65 mg drug capsules, oral, 3 single doses
Eligibility criteria:
Inclusion Criteria:

Provision of written consent
GERD patients, age 18-70 years, females must be postmenopausal or surgically sterilised
6 months history of GERD and incomplete response to PPI treatment

Exclusion Criteria:

Insufficient symptom burden of the reflux disease evaluated by questionnaires
S-creatinine >1.2 times upper limit of normal
History of heart disease
Prior surgery of the upper GI tract
Intervention: Medroxyprogesterone acetate
Trial phase: Not Applicable
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)

Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)

Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)

Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days
Eligibility criteria:
Inclusion Criteria:

Premenopausal women (ages 18-40 years) with normal thyroid function and prolactin levels.

PCOS diagnosis based on Rotterdam criteria: presence of at least 2 of the following criteria:

oligomenorrhea-menstrual cycles > 35 day intervals
hyperandrogenemia (elevated serum testosterone [free or total] &/or androstenedione levels) or features of hyperandrogenism i.e. acne or hirsuitism [Ferriman-Gallaway score > 3]
polycystic ovaries on vaginal ultrasound as defined by ESHRE/ASRM criteria (ovarian volume ≥ 10mL or ≥ 12 follicles of diameter between 2-9mm in at least one ovary)
Overweight (BMI ≥ 27 Kg/m2)
Biochemical evidence of Vitamin D insufficiency (i.e. serum 25 OHD levels < 20ng/mL)

Exclusion Criteria:

Pregnancy
Known causes of oligomenorrhea other than PCOS, e.g. hypothyroidism/Cushing's Disease/late onset congenital adrenal hyperplasia (fasting 17-alphahydroxyprogesterone levels < 200ng/dL)
Use of hormonal treatment (birth control pill/patch/depot medroxyprogesterone/medroxyprogesterone) within 3 months of the study onset.
Use insulin sensitizers (metformin, sulfonylureas, TZDs, incretins) within 3 months of the study onset.
Use of lipid lowering agents or medications known to influence insulin sensitivity (e.g. niacin, corticosteroids, beta blockers, calcium channel blockers, thiazide diuretics) or influence serum androgens (estrogen, anti-androgens, androgens) within 3 months of the study onset.
Known history of renal calculi or current use of Calcium and Vitamin D supplements.
Spanish Speaking.
Intervention: Prazosin
Trial phase: Phase 3
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: prazosin (16mg/day)

Prazosin: prazosin (16mg/day) 2 times a day
Eligibility criteria:
Inclusion Criteria:

Males and females between the ages of 21-65 years old.
Current alcohol dependence, as determined by a structured clinical interview (Structured Clinical Interview for DSM-IV Axis I Disorders) (SCID) (First et al. 1996).
Current PTSD as determined by the Clinician Administered PTSD Scale for DSM-IV(CAPS) (Blake et al. 1995).
Patients with current alcohol dependence, with at least one recent episode of heavy drinking (defined as 5 or more drinks per drinking episode) over the past 14 days.
Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories (CBC w/ differential, TSH, Free-T4, ASAT, ALAT, GGT, BUN, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes, VDRL, urinalysis, beta-HCG).
For women, negative pregnancy test and use of acceptable method of contraception.

Exclusion Criteria:

Females who are pregnant or lactating.
Individuals with a current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology (LFT 5 times normal, abnormal BUN and creatinine, and unmanaged hypertension with BP more than 200/120) which in the opinion of the physician would preclude the patient from fully cooperating or be of potential harm during the course of the study.
Patients who meet current SCID criteria for the following major Axis I diagnoses (Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders).
History of substance dependence (other than alcohol, cocaine, tobacco or cannabis) by DSM-IV criteria in the last 30 days.
Individuals taking mood stabilizers and antipsychotic medications.
Individuals with a history of sensitivity to quinazolines or prazosin.
Individuals taking medications thought to influence alcohol consumption (naltrexone, disulfiram, acamprosate).
Individuals taking adrenergic medication (e.g. clonidine).
Agents that may interact with prazosin such as drugs with CNS depressant effects including tizanidine and xyrem.
Intervention: Sitaxentan sodium
Trial phase: Not Applicable
SMILES: Cc1cc2c(cc1CC(=O)c1sccc1S(=O)(=O)[N-]c1onc(C)c1Cl)OCO2.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: ET - ARA 1 mg / kg
Eligibility criteria:
Inclusion Criteria:

>60 years of age
Body mass index <40 kg/m2
Left ventricular ejection fraction less than or equal to 50% documented by a pre-operative echocardiogram
Patients undergoing coronary artery bypass (CABG), aortic and/or mitral valve replacement or combined CABG and valve procedures requiring CPB.
If diabetic, be under proper control, (fasting glucose <350 mg/dL or recent hemoglobin A1c [HgbA1c] <9%).
If hypertensive, be on a stable medical regimen with no significant changes over the past 30 days.
Female of child bearing potential with a negative pregnancy test, or post-menopausal for at least 2 years
The patient is an appropriate study candidate as determined by the Investigator on the basis of medical history and physical examination

Exclusion Criteria:

Emergent revascularization
Previous stroke or thrombo-embolic event in the 3 months prior to study entry
A previous myocardial infarction within the last 7 days
Documented coagulopathy
Hepatic dysfunction as defined by aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times the upper limit of normal
Patient is pregnant or breastfeeding
Intervention: Sitaxentan sodium
Trial phase: Not Applicable
SMILES: Cc1cc2c(cc1CC(=O)c1sccc1S(=O)(=O)[N-]c1onc(C)c1Cl)OCO2.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: ET - ARA 2 mg / kg
Eligibility criteria:
Inclusion Criteria:

>60 years of age
Body mass index <40 kg/m2
Left ventricular ejection fraction less than or equal to 50% documented by a pre-operative echocardiogram
Patients undergoing coronary artery bypass (CABG), aortic and/or mitral valve replacement or combined CABG and valve procedures requiring CPB.
If diabetic, be under proper control, (fasting glucose <350 mg/dL or recent hemoglobin A1c [HgbA1c] <9%).
If hypertensive, be on a stable medical regimen with no significant changes over the past 30 days.
Female of child bearing potential with a negative pregnancy test, or post-menopausal for at least 2 years
The patient is an appropriate study candidate as determined by the Investigator on the basis of medical history and physical examination

Exclusion Criteria:

Emergent revascularization
Previous stroke or thrombo-embolic event in the 3 months prior to study entry
A previous myocardial infarction within the last 7 days
Documented coagulopathy
Hepatic dysfunction as defined by aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times the upper limit of normal
Patient is pregnant or breastfeeding
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.

Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
Eligibility criteria:
Inclusion Criteria:

Patients requiring mechanical ventilation in the medical or surgical ICUs.
Currently receiving lorazepam or midazolam by continuous infusion for the purpose of sedation therapy.
Sedation in these ICUs is provided using an ICU-wide order form that preferentially uses either lorazepam or midazolam with the infusion rate titrated by the bedside nurse to the desired Riker sedation-agitation score(s). Continuous analgesia is provided with fentanyl only with the infusion rate titrated by the bedside nurse to PABS ≤ 3 .
Anticipated duration of continuous sedation > 12 hours with the level of sedation expected to be maintained at Riker sedation-agitation score(s) of 3 - 4.

Patients qualifying for daily awakenings as determined by all of the following:

fraction of inspired oxygen (FiO2) ≤ 70% or
positive end expiratory pressure (PEEP) ≤ 14 cmH2O,
hemodynamically stable, and
NOT receiving pharmacologic neuromuscular blockade.
Informed consent and HIPAA authorization within 24 hours of qualifying for daily awakenings.

Exclusion Criteria:

Patients < 18 years of age or > 85 years of age.
Patients receiving intermittent or "as needed" administration of lorazepam or midazolam.
Patients receiving lorazepam or midazolam for purposes other than sedation (e.g. seizure control).
Patients receiving epidural administration of medication(s).
Patients with Childs-Pugh class C liver disease.
Comatose patients by metabolic or neurologic affectation.
Patients with active myocardial ischemia or second- or third-degree heart block.
Moribund state with planned withdrawal of life support.
Patients with known or suspected severe adverse reactions to midazolam (or any other benzodiazepine) or dexmedetomidine (or clonidine).
Patients with alcohol abuse within six months of study eligibility.
Pregnant females or females suspected of being pregnant.