anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Vortioxetine
Trial phase: Phase 3
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 139
Group description: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current major depressive episode is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.
A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

Exclusion Criteria:

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale, or has made a suicide attempt in the previous 6 months.
Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Has a clinically significant unstable illness.
Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
Has received electroconvulsive therapy within 6 months prior to Screening.
Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.
Has a serum creatinine of > 1.5 × upper limit of normal.
Has a previous history of cancer that had been in remission for less than 5 years.
Has thyroid stimulating hormone value outside the normal range.
Has an abnormal electrocardiogram.
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Metformin XR 2000 mg daily

Glucophage (Metformin): metformin XR 2000 mg daily for 12 months
Eligibility criteria:
Inclusion Criteria:

biopsy-proven NAFLD, determined within 12 months of study initiation

Exclusion Criteria:

> 20 grams of alcohol/day
impaired oral glucose tolerance test
known diagnosis of diabetes mellitus
hepatitis C infection
cirrhosis
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 224
Group description: acetaminophen

acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days.
Eligibility criteria:
Inclusion Criteria:

age 18 or older

Exclusion Criteria:

History of acetaminophen ingestion on any of the four days preceding study enrollment
Measurable serum acetaminophen level at time of enrollment
Viral markers of Hepatitis B or C, or viral markers of Hepatitis A with an ALT level greater than ULN during screening laboratory testing
Serum ALT or AST level greater than ULN at Screening or Day 0
Total bilirubin level greater than ULN at Screening or Day 0
INR level greater than ULN at Screening
Alkaline phosphatase level greater than ULN at Screening
Platelet count less than 125 10^9/L at Screening
Known cholelithiasis
Positive pregnancy test at Screening (female participants only)
History of consuming more than an average of 3 alcohol containing drinks daily over the preceding 2 weeks
History of consuming 3 or more alcohol containing drinks on any given day during the 2 weeks prior to study enrollment
New prescription medication started within the previous 30 days
Currently taking isoniazid
Currently taking warfarin
Currently adheres to a fasting type diet as determined by self report
Currently has anorexia nervosa as determined by self report
Participant is clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
Known hypersensitivity or allergy to acetaminophen
Intervention: Methotrexate
Trial phase: Phase 2 | Phase 3
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Heart failure functional class measured using the New York Heart Association classification class II, III or IV
Left ventricular fraction <0.45 at the ventriculography
Angiographic coronary lesions higher than 50% or coronary lesion revascularized (coronary artery bypass or percutaneous transluminal coronary angioplasty)

Exclusion Criteria:

Myocardial infarction in the past four months
Coronary artery bypass or percutaneous transluminal coronary angioplasty in the past four months
Left ventricular disfunction diagnosed during a acute coronary syndrome
Those who require revascularization in the following 12 weeks
Hepatic disease (ALT and AST higher than the upper limit of the reference value)
Renal failure (plasma creatinine higher than 2.0mg/dl)
Alcoholism (20 doses per week or more)
Illegal drug use
Rheumatoid arthritis or other inflammatory diseases
Infectious disease
Neoplasm
Anemia (hematocrit lower than 30%)
Currently on any anti-inflammatory drugs
Difficulty in walking
Unable to understand/complete the 36-item Short Form health survey (SF-36)
Those who do not give informed consent
Intervention: Ampicillin
Trial phase: Phase 2
ATC code: J01CA01 | J01CA51 | J01CR50 | S01AA19
SMILES: [H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 224
Group description: Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.

Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.

Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm
Eligibility criteria:
Inclusion Criteria:

Children diagnosed as having cleft palates undergoing palatoplasty between the ages of 3 months and 18 years will be included in this study. Palatoplasty is the current standard of care in the sequence of treatment for cleft secondary palates. Pediatric plastic surgeons work primarily with children, and have undergone extensive training during their residencies and pediatric surgical fellowships to do so. Children will be evaluated initially at the Cleft-Craniofacial Center at the Children's Hospital of Pittsburgh of UPMC, which is set up to accommodate children of all ages and their families. Approximately 300 children will be required to contribute to a meaningful analysis.

Exclusion Criteria:

All patients requiring prophylactic antibiotics for spontaneous bacterial endocarditis, with documented allergic reactions to the ampicillin-sulbactam, and with known immunodeficiencies or immunodeficiency associated syndromes, such as the 22q chromosomal deletion, will be excluded from study participation.
Selection will be based on the parent's willingness to allow their child to participate in the study.
Children already receiving antibiotics at the time of their surgery will be evaluated distinctly, though they will not be included in the antibiotic or the placebo groups
Intervention: Domperidone
Trial phase: Phase 2
ATC code: A03FA03
SMILES: O=c1[nH]c2ccccc2n1CCCN1CCC(n2c(=O)[nH]c3cc(Cl)ccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
Eligibility criteria:
Inclusion Criteria:

Male or female
Age 18 and older
Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.

Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

Increased prolactin levels
Breast changes
Extrapyramidal side effects
Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
Gastrointestinal hemorrhage or obstruction.
Presence of a prolactinoma (prolactin-releasing pituitary tumor).
Pregnant or breast feedings female.
Known allergy to domperidone
Intervention: Methadone
Trial phase: Not Applicable
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Methadone comparison to standard of care for pain management

Methadone: Compare to standard of care for pain management of acute episode of pain
Eligibility criteria:
Inclusion Criteria:

Greater than or equal to 7 years and less than or equal to 40 years
Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
Admitted to the inpatient unit for further treatment
Started on morphine patient controlled analgesia and infusion for pain management

Exclusion Criteria:

Diagnosis of acute chest syndrome
New focal neurologic findings or clinical concern of stroke
Aplastic crisis with hemoglobin 2 g/dl below steady-state value
Allergy to morphine or methadone
Any other medical condition that the attending physician deems to be a contraindication to therapy
Liver or renal insufficiency or failure, and congestive heart failure
Intervention: Latanoprost
Trial phase: Phase 3
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 348
Group description: One drop self-administered in the study eye(s) once daily for 90 days
Eligibility criteria:
Inclusion Criteria:

18 years or older.
Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.
Best corrected visual acuity of -0.6 logMAR or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
Use of contact lenses within 30 days of Visit 1.
Use of contact lenses during the study.
Participation in an investigational drug or device study within 30 days of entering this study.
Other protocol-defined exclusion criteria may apply.
Intervention: Ribavirin
Trial phase: Phase 3
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 94
Group description: Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
Eligibility criteria:
Inclusion Criteria:

Informed consent must be obtained from the participant or the participant's parent or legal guardian prior to any long-term follow-up study-related procedures. According to local laws and/or IRB/IEC requirements, participants may also need to provide written assent.
The participant must have received at least one dose of peginterferon alfa-2b and ribavirin in the Protocol No. P02538 study.
The participant must have completed the 24-week post-treatment follow-up in the P02538 Part 1 study. All participants whether sustained responders, relapsers, or nonresponders are eligible to participate.

Exclusion Criteria:

Concurrent participation in any other clinical study.
Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuation from, the treatment phase of the P02538 Part 1 study.
Any condition that in the opinion of the Investigator would make the participant unsuitable for enrollment.
Intervention: Withaferin A
Trial phase: Phase 3
SMILES: CC1=C(CO)C(=O)OC(C(C)C2CCC3C4CC5OC56C(O)C=CC(=O)C6(C)C4CCC23C)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Sensoril(Ashwagandha)

Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks.
Eligibility criteria:
Inclusion Criteria:

DSMIV-TR diagnosis of Bipolar Disorder
Ages 18 to 65
Men or Women
8th grade education or greater
Able to provide competent written informed consent
Current main mood stabilizer and mood status (YMRS and MADRS scores less than or equal to 10) are stable for greater than or equal to 4 weeks by history.

Exclusion Criteria:

Medically unstable conditions
Known allergy to Sensoril® (or Ashwagandha)
Current cognitive decline is attributable to a diagnosis of dementia or other neurological disorder
Pregnant or lactating women
Mini-mental score (MMSE) less than or equal to 23
Currently receiving donepezil, rivastigamine, or galatamine, or memantine or any marketed agent for slowing memory loss in dementia
Abnormal clinical thyroid status
Currently (or within past 2 weeks) receiving St. John's Wort, Gingko or Omega-3
Intervention: Repaglinide
Trial phase: Not Applicable
ATC code: A10BD14 | A10BX02
SMILES: CCOc1cc(CC(=O)N[C@@H](CC(C)C)c2ccccc2N2CCCCC2)ccc1C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Repaglinide intervention group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
Eligibility criteria:
Inclusion Criteria:

Male or females 12 -24 years old
Diagnosis of Cystic Fibrosis by sweat test with exocrine pancreatic insufficiency
Must have a glucose pattern by Oral Glucose Tolerance Test with fasting blood glucose <126 mg/dl and 2 hour: 140 - 199 mg/dl or >200 mg/dl.
Weight must be stable within 5% for 3 months prior to initiation visit
Must be able to reproducibly perform spirometry based on American Thoracic Society guidelines

Exclusion Criteria:

Patients receiving growth hormone therapy or taking insulin
Patients with evidence of liver dysfunction
Patients who are status-post lung or liver transplantation
Patients who have received systemic steroids for more than 28 days during the 6 months prior to the study
Patients with active ABPA on steroids
Patients taking medications that affect glucose metabolism or contraindicated with repaglinide
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 95
Group description: 2 x 500 mg acetaminophen by mouth once
Eligibility criteria:
Inclusion Criteria:

self-declared white/Caucasian
self-declared African-American
active
ambulatory
no evidence of medical disease

Exclusion Criteria:

alcohol use of 3 or more drinks per day
HIV or hepatitis (B or C) infection
isoniazid
disulfiram
phenobarbital
phenytoin
carbamazepine
rifampicin
valproic acid
probenecid
St. John's Wort
Intervention: Phenazopyridine hydrochloride
Trial phase: Phase 4
SMILES: Cl.Nc1ccc(N=Nc2ccccc2)c(N)n1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 258
Group description: Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first

phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24
Eligibility criteria:
Inclusion Criteria:

1. Adult women undergoing gynecologic surgery who are expected to tolerate oral medication within 12 post-operative hours and require an indwelling catheter for a minimum of 12 post operative hours after start of oral medication.

Exclusion Criteria:

Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products).

Known contraindications to phenazopyridine HCl:

Renal failure or insufficiency (Defined as having abnormal renal function on previous laboratory testing (BUN/Cr) or as having a known renal disease).
History of hepatic disease or failure (Defined as having known liver disease or having elevated LFTs on previous laboratory testing. Patients who would not otherwise have such testing are not required to undergo special study labs).
Known glucose-6-phosphate dehydrogenase deficiency.
Simultaneous suprapubic catheterization.
Inability to take oral medication within 12 hours after surgery.
Pregnant women.
Intervention: Imiquimod
Trial phase: Phase 4
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
Eligibility criteria:
Inclusion Criteria:

A clinical diagnosis of actinic keratoses

Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp:

each area with a minimum of 25 cm^2 and a maximum of 50 cm^2
each area with at least 6 typical, non-hypertrophic target AKs
with target AK lesion counts of +/- 1 lesion between the areas
each area that the patient can distinguish with respect to study drug application
Able to comply with all study requirements
Are willing and able to give written informed consent

Exclusion Criteria:

Uncontrolled intercurrent or chronic illness
Systemic immunocompromise due to disease or treatment
Clinically relevant systemic autoimmune disease
Pregnant or nursing
Dermatologic disease and/or condition in the treatment area that may be exacerbated by imiquimod or cause difficulty with examination
Participation in another clinical study
Allergies to imiquimod or any of the excipients in the cream

Treatment within the past 90 days with any of the following:

Psoralens plus ultraviolet A therapy
Ultraviolet B therapy
Systemic immunomodulators (e.g. oral or parenteral corticosteroids at greater than physiologic doses, interferons, anti-TNF agents, cytokines)
Chemotherapeutic or cytotoxic agents;
Investigational agent

Treatment within the past 30 days with any of the following:

Surgical excision
Photodynamic therapy
Curettage
Topical corticosteroids
Laser
Dermabrasion
Chemical peel
Imiquimod 5% cream
Topical retinoids
5-fluorouracil
Masoprocol
Pimecrolimus or tacrolimus