anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 75
Group description: Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
Eligibility criteria:
Inclusion Criteria:

Outpatients with a diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
Duration of illness greater than 1 year, as defined by having initiated antipsychotic treatment at least 1 year prior to study entry
Adequate decisional capacity to make a choice about participating in this research study
Body mass index (BMI) at or greater than 27
Currently being treated with one or a combination of two antipsychotic medications (typical or atypical) and on that drug regimen for at least 2 months prior to study entry, with stable dosages for at least 1 month
If taking antidepressants, mood stabilizers, or anxiolytics, the dose must be stable for at least 1 month prior to study entry
Willing to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study. Acceptable methods include oral, injectable, or implanted contraceptives; intrauterine devices or barrier methods such as condoms; and diaphragms and spermicides.

Exclusion Criteria:

Inpatient status
Clinical Global Impression Severity (CGI-S) score greater than 6
Currently being treated with more than two antipsychotic medications
Fasting glucose greater than 125
Diagnosis of diabetes mellitus or treatment with insulin or oral hypoglycemics
Previous or current treatment with metformin
Diagnosis of congestive heart failure
Renal impairment, as defined by a serum creatinine level greater than 1.5 in males or greater than 1.4 in females, or creatinine estimated glomerular filtration rate (GFR) outside of normal limits
Hepatic disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), or c-glutamyl transferase (CGT) greater than 1.5 times upper limit of normal (ULN), or total bilirubin greater than 1.2 times ULN
Metabolic acidosis, as defined by serum carbon dioxide less than the lower limit of normal
Known hypersensitivity to metformin
Pregnant or breastfeeding
Recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material
Alcohol abuse or dependence within the past month, as determined by the SCID
Other serious and unstable medical condition in the judgment of the investigator
Diagnosis of mental retardation, delirium, or dementia, as defined by DSM-IV-TR
Failed to discontinue 4 weeks prior to study entry any medication used for weight loss
Concurrent treatment with certain drugs that are known to increase metformin blood levels should be discussed with the Project Medical Officer.
Intervention: Tretinoin
Trial phase: Phase 3
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 296
Group description: Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
Eligibility criteria:
Inclusion Criteria:

all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
rated as severe by the physician
unresponsive to highly potent topical corticosteroids, such as clobetasol

Exclusion Criteria:

patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
patients with psoriasis lesions
active fungal, bacterial or viral infections of the hands
female patients who are pregnant or breastfeeding
female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception
Intervention: Repaglinide
Trial phase: Phase 4
ATC code: A10BD14 | A10BX02
SMILES: CCOc1cc(CC(=O)N[C@@H](CC(C)C)c2ccccc2N2CCCCC2)ccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 214
Group description: Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with type 2 diabetes
Never taken oral antidiabetic drugs before
HbA1c greater than 8.5 %
BMI (Body Mass Index) less than or equal to 35 kg/m^2

Exclusion Criteria:

Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
Taken an investigational drug in another clinical trial within 4 weeks prior to this trial
Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit
Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)
Impaired renal function
Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
Have a clinically significant, active cardiovascular disease, or decompensated heart failure
Treatment with systemic corticosteroids within the past two months prior to screening
Intervention: Beclomethasone
Trial phase: Phase 4
ATC code: A07EA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Treated Smokers will be administered with 320 micrograms (mcg) of beclomethasone daily from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. The dose will be 2 puffs twice a day for 7 days.
Eligibility criteria:
Inclusion Criteria:

All Smokers (Treated and Non-Treated)

All study individual should be enrolled in Weill-IRB protocol #0005004439 entitled "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy"
All study subjects should be able to provide informed consent
Current smokers with 15-to 40 pack-year history
All study individuals should be healthy as per protocol #0005004439 entitled "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy"

Non-Smokers

All study individual should be enrolled in Weill-IRB protocol #0005004439 entitled "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy"
All study subjects should be able to provide informed consent
All study individual should be healthy as per protocol #0005004439 entitled "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy"

Exclusion Criteria:

All Smokers

Smokers intending to quit smoking in the next 14 days.
Individuals already receiving any lung related inhalers
Females who are pregnant or nursing

Non-Smokers

Exclusion Criteria:

Non-smokers who intend to start smoking in the next 14 days
Individuals already receiving any lung related inhalers
Females who are pregnant or nursing
Intervention: Tadalafil
Trial phase: Phase 3
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 161
Group description: Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
Eligibility criteria:
Inclusion Criteria:

Men 45 years of age or older with Benign Prostatic Hyperplasia (BPH) also referred to as BPH-LUTS [lower urinary tract symptoms] based on the disease diagnostic criteria at the start of study.
Provide signed informed consent at the start of the study.
Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
Have not taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

Treated with nitrates for a cardiac conditions.
Have unstable angina or angina that requires treatment.
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have very high or very low blood pressure
Have problems with kidneys, liver, or nervous system.
Have uncontrolled diabetes.
Have had a stroke or a significant injury to brain or spinal cord.
Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (Prostate-Specific Antigen [PSA] greater than 10 nanograms/milliliter [ng/ml] at the start of study).
Intervention: Palonosetron
Trial phase: Phase 3
ATC code: A04AA05 | A04AA55
SMILES: [H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 74
Group description: Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)

palonosetron: palonosetron IV 1 mcg/kg
Eligibility criteria:
MAIN INCLUSION CRITERIA

Male or female patient aged more than 28 days (full term) up to and including 16 years.

Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:

ear, nose and throat surgery;
eye surgery;
orchidopexy;
plastic reconstructive surgery;
herniorraphy;
orthopedic surgery).
American Society of Anesthesiologists (ASA) physical status I, II or III.
Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.

MAIN EXCLUSION CRITERIA

For infant aged more than 12 months: a history of gastro-esophageal reflux.
For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
Patient scheduled to undergo emergency surgery.
Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
Patient scheduled to receive propofol during the maintenance phase of anesthesia.
Patient with vomiting from any organic cause.
Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.
Intervention: Palonosetron
Trial phase: Phase 3
ATC code: A04AA05 | A04AA55
SMILES: [H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 76
Group description: Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)

palonosetron: palonosetron 3mcg/kg IV
Eligibility criteria:
MAIN INCLUSION CRITERIA

Male or female patient aged more than 28 days (full term) up to and including 16 years.

Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:

ear, nose and throat surgery;
eye surgery;
orchidopexy;
plastic reconstructive surgery;
herniorraphy;
orthopedic surgery).
American Society of Anesthesiologists (ASA) physical status I, II or III.
Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.

MAIN EXCLUSION CRITERIA

For infant aged more than 12 months: a history of gastro-esophageal reflux.
For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
Patient scheduled to undergo emergency surgery.
Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
Patient scheduled to receive propofol during the maintenance phase of anesthesia.
Patient with vomiting from any organic cause.
Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.
Intervention: Dopamine
Trial phase: Phase 1
ATC code: C01CA04
SMILES: NCCc1ccc(O)c(O)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Other Names:

Sinemet L-dopa

Dosages are based on levodopa.

Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.

Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.

Levodopa/Carbidopa (4:1): Dosages are based on levodopa.

Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.

Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.
Eligibility criteria:
Inclusion Criteria:

Angelman syndrome, confirmed by molecular testing
Must be willing to come for research visit on 2 days, exactly 1 week apart

Exclusion Criteria:

On levodopa, carbidopa, or any dopamine agonists in the 2 weeks prior to participation
Other medical conditions that may be associated with developmental or cognitive delays
More than 2 clinical seizures per month
Used monoamine oxidase (MAO) inhibitors within the last 2 weeks
Used phenytoin within the last 2 weeks
Used phenothiazines, butyrophenones, and thioxanthenes within last 2 weeks
Hypersensitive to levodopa or carbidopa
Cardiovascular disease or instability
Respiratory diseases, including asthma, emphysema, chronic cough, and shortness of breath
Liver disease
Stomach or intestinal ulcers
Kidney disease
Hematological problems, including anemia, leucopenia, and thrombocytopenia
Used investigational drugs/interventions within the past three months
Intervention: Montelukast Sodium
Trial phase: Phase 4
SMILES: CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 445
Group description: Montelukast 4-5 mg for 12 weeks, oral tablet
Eligibility criteria:
Inclusion Criteria:

Patient Is Diagnosed With Asthma For At Least 6 Months
Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10)
Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage
Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To Non-Adherence With Current Therapy Through The Preceding 6 Weeks

Exclusion Criteria:

As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol (Serevent)) Or A Combination Product (Advair Or Symbicort)
Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy
Intervention: Tretinoin
Trial phase: Phase 4
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Tretinoin gel 0.025%
Eligibility criteria:
Inclusion Criteria:

Facial acne vulgaris characterized by the following:

30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

Non-compliance with washout period;
History of clinically significant anemia or hemolysis;
Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
Allergy or sensitivity to any component of the test medications
Intervention: Metformin
Trial phase: Phase 2
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
Eligibility criteria:
Inclusion Criteria:

Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
Less than 24 weeks at study enrollment
Singleton or twin pregnancy
English or Spanish speaking
Able to give informed consent

Exclusion Criteria:

End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
Prior need for insulin for glycemic control
History of diabetic ketoacidosis (DKA) or hyperosmolar state
Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
Kidney or liver disease
Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
Intervention: Tadalafil
Trial phase: Phase 3
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 147
Group description: Tadalafil 5 milligrams administered orally once a day over 12 weeks. Dosing started at 5 mg tadalafil daily (or matching placebo) and could be down-titrated to 2.5 mg tadalafil daily (or matching placebo) based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Eligibility criteria:
Inclusion Criteria:

You are male and aged at least 18 years.
Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication
Your entry laboratory test results and medical tests meet study requirements
You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor.
If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.

Exclusion Criteria:

You have received previous or current treatment with tadalafil or any other PDE5 inhibitor.
Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®).
You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff.
Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
Intervention: Rabeprazole
Trial phase: Phase 4
ATC code: A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03
SMILES: COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
Eligibility criteria:
Inclusion Criteria:

Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization
patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy

Exclusion Criteria:

Patients who refuse endoscopic procedure
Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation)
Pregnancy
Patients with serious concurrent diseases such as malignant tumors or end-stage diseases
History of previous gastrectomy or vagotomy
Known hypersensitivity to proton pump inhibitors
Elderly patients
Epilepsy