anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Canagliflozin
Trial phase: Phase 4
ATC code: A10BD16 | A10BK02
SMILES: [H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).
Eligibility criteria:
Inclusion Criteria:

Post Roux-n-Y gastric bypass (RYGB) surgery and sleeve gastrectomy (SG) patients who underwent surgery >1 and <15 years ago in the Cleveland surrounding area
Age 20-75 years of age
Type II Diabetes Mellitus (D2M) diagnosis (history, medication usage, biochemical criteria) prior to and after surgery; after surgery, defined by a single HbA1c of greater or equal to 6.5% at consent and screening.
Metformin patients must have an HbA1c greater than or equal to 6.5% but less than or equal to 10% at randomization; for diet controlled patients (i.e. not on any T2D medication), HbA1c must be greater than or equal to 6.5% at randomization.
Patient reporting of improvement in T2D status or objective improvements in T2D status at any time post-surgery.
estimated glomerular filtration rate (eGFR) ≥ 60mL/min prior to randomization
Has the ability and willingness to provide informed consent.
Is able to understand the options and to comply with the requirements of each program
Female subject agrees to have a serum pregnancy test at screening. A negative serum pregnancy test result is required prior to randomization.
Female patients must agree to use a reliable method of contraception for 6 months or duration of intervention
Patients taking an anti-diabetic medication, except insulin, are eligible and must agree to washout for 8 weeks prior to the randomization visit.

Exclusion Criteria:

Type 1 diabetes indicated by history of diabetic ketoacidosis and lack of remission in response to bariatric surgery
Other post bariatric procedures (banding, duodenal switch, biliopancreatic diversion)
Current use of insulin.
End organ diabetic complications (renal failure, cardiomyopathy, severe neuropathy/foot ulcers)
Documented severe or unstable depression/anxiety or eating disorder that would not enable patient to adhere to anti-diabetic treatment
Clinical contraindications to use canagliflozin, i.e., history of bladder cancer, Child-Pugh class C
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 165
Group description: Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Eligibility criteria:
Inclusion Criteria:

Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
Subject must have at least moderate pain on the 4-point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less than or equal to 5 hours, 15 minutes) after surgery is completed.
Female subjects are not pregnant or breast feeding.
Informed consent.

Exclusion Criteria:

Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening.
Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation.
Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
Intervention: Timolol Maleate
Trial phase: Phase 2
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 44
Group description: Subjects assigned to this arm will be randomized to 0.25% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.25% timolol they will be changed to 0.5% timolol.

0.25% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution
Eligibility criteria:
Inclusion Criteria

Documented informed consent from legal guardian
0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort.

Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following):

Superficial lesion in the dermis
Thin <2 mm in thickness
Small >=5 cm at its longest dimension and <=10cm2
Involves skin or keratinized mucosa

Exclusion Criteria

History of previous treatment with any pharmacologic or laser therapy for IH
Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot (TOF), hypertension, reactive airways disease)
IH that requires systemic therapy (defined by dynamic complication scale >3)
IH of the non-keratinized mucosa
Infants with more than one hemangioma that requires therapy
Hemodynamically significant cardiovascular disease, as determined by the investigator
Known allergy to beta blockers or vehicle
Heart rate <100 beats per minute at screening visit
Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block
History of Reactive Airways Disease (RAD)
Any condition which would make the participant, in the opinion of the investigator unsuitable for the study.
Intervention: Timolol Maleate
Trial phase: Phase 2
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 51
Group description: Subjects assigned to this arm will be randomized to 0.5% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.5% timolol the treating physician will decide to either continue 0.5% timolol or withdraw the subject and begin an alternative treatment.

0.5% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution
Eligibility criteria:
Inclusion Criteria

Documented informed consent from legal guardian
0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort.

Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following):

Superficial lesion in the dermis
Thin <2 mm in thickness
Small >=5 cm at its longest dimension and <=10cm2
Involves skin or keratinized mucosa

Exclusion Criteria

History of previous treatment with any pharmacologic or laser therapy for IH
Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot (TOF), hypertension, reactive airways disease)
IH that requires systemic therapy (defined by dynamic complication scale >3)
IH of the non-keratinized mucosa
Infants with more than one hemangioma that requires therapy
Hemodynamically significant cardiovascular disease, as determined by the investigator
Known allergy to beta blockers or vehicle
Heart rate <100 beats per minute at screening visit
Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block
History of Reactive Airways Disease (RAD)
Any condition which would make the participant, in the opinion of the investigator unsuitable for the study.
Intervention: Tobramycin
Trial phase: Phase 4
ATC code: J01GB01 | S01AA12
SMILES: NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Subjects receive IV tobramycin 8-10 mg/kg/day with once daily dosing for 14 days. Peaks and troughs are drawn with the second dose of tobramycin, and the drug is infused over 30 minutes

Tobramycin
Eligibility criteria:
Inclusion Criteria:

Male or female ≥ 18 years of age at Visit 1.

Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:

Sweat chloride equal or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test.
Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Abnormal nasal potential difference (NPD) as measured by a change in NPD in response to a low chloride solution and isoproterenol of less than -5 mV.
Documentation of the presence of an acute pulmonary exacerbation, based on CF Foundation guidelines, as diagnosed by a faculty member of the Denver Adult CF Program.
Respiratory culture(s) demonstrating evidence of Pseudomonas aeruginosa or Achromobacter species airway infection.
Subject is able to produce sputum, undergo phlebotomy, and provide written consent.
The subject's treating physician has determined that they should receive either tobramycin or colistin intravenously as one of the designated agents for their APE treatment. Subjects who are able to receive either tobramycin or colistin as part of their antibiotic regimen will be randomized into one of three arms. If a treating physician deems that a subject cannot receive tobramycin due to vestibular toxicity, ototoxicity or bacterial resistance, the subject will be randomized to either standard or PK-adjusted colistin.

Exclusion Criteria:

Concomitant administration of bactrim (due to effects on creatinine).
Concomitant administration of inhaled colistin for patients in the colistin PK arm, as this will create inaccuracies in colistin sputum concentration measurements.
Patients being treated for B. cepacia, due to colistin resistance by the pathogen.
Presence of chronic renal insufficiency, with abnormal baseline creatinine >1.2mg/dL.
Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
Inability to perform reproducible spirometry.
Inability to expectorate sputum. -
Intervention: Canagliflozin
Trial phase: Phase 4
ATC code: A10BD16 | A10BK02
SMILES: [H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.

Canagliflozin
Eligibility criteria:
Major Inclusion Criteria:

Symptomatic stable heart failure (New York Heart Association (NYHA) functional classification II-III) with reduced left ventricular ejection fraction (LVEF) ≤40%
Peak exercise limited by shortness of breath and associated with a respiratory exchange ratio (RER) >1.00 (reflecting maximal aerobic effort);
Poorly controlled Type 2 Diabetes Mellitus (T2DM)(HbA1c levels between 7.0% and 10.0% if on a treatment regimen including insulin, or between 6.5% and 10.0% if not on an insulin regimen);
Eighteen years of age or older.

Major Exclusion Criteria:

Type I diabetes;
Open label treatment with Sodium-GLucose coTransporter (SGLT)-2 inhibitors (within the past 3 months);
Current treatment with thiazolidinedione (within the past 3 months);
Chronic Renal Disease defined as Glomerular Filtration Rate (GFR) <50 ml•min-1/1.73m2 according to local laboratory
Pregnancy or of child-bearing potential or lactating;
Active or recent (within 2 weeks) genital/urinary infection;
Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e, physical inability to walk or run on a treadmill
Inability to give informed consent.

Exclusion criteria specific to the cardiac magnetic resonance (CMR) substudy.

Estimated GFR <60 ml•min-1/1.73m2
Implantable cardioverter defibrillator, pacemaker or other implantable metal device not compatible with CMR scanning;
Severe claustrophobia, inability to lay flat for up to 60 minutes, or other contraindication to CMR scanning.
Intervention: Fluoxetine
Trial phase: Phase 2
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Subjects randomized to treatment arm will receive fluoxetine with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.

Fluoxetine: Standard 6 weeks titration, starting 10 mg per day.
Eligibility criteria:
Inclusion Criteria:

Adult patients aged 18 or older
Patients with epilepsy
Native English speaker or adequate fluency in English to provide informed consent.
Female patients of child-bearing potential must be using an acceptable method of contraception, and willing to refrain from sexual intercourse during the study.

Exclusion Criteria:

Progressive neurological disease.
Clinical diagnosis of bipolar disease, panic disorder, psychosis or severe depression, or PHQ-9 score > 20
Patients with prior hospitalization related to depression or Electroconvulsive therapy.
History of suicidal ideation or intent in past or present
Clinical history or laboratory evidence of hepatic or renal insufficiency.
Pregnant or lactating women.
Current heavy alcohol use (>14 drinks per week for men or >7 drinks per week for women) or) known medical disorder related to alcohol use or current illicit drug use, other than marijuana and its derivatives.
Patients with recent use (<1 month) or already taking fluoxetine or other selective serotonin reuptake inhibitors (SSRIs).
Concurrent use of monoamine oxidase inhibitors, antipsychotic agents, antidepressant agents other than SSRIs or frequent use of triptan agents (>2/week).
History of a previous allergic reaction or adverse effects with fluoxetine, hypersensitive reaction-anaphylaxis; laryngeal edema; hives
History of serotonin syndrome.
History of uncontrolled pulmonary or cardiac illness.
Patients with hypercapnic ventilatory response (HCVR) slope of > 2.0
Patients with known prolong QT interval
Patients with family history of prolong QT interval
Patients with family history of sudden cardiac death under the age of 40 in a first degree relative.
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation.

Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks.

Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.
Eligibility criteria:
Inclusion Criteria:

All individuals diagnosed with Atrial Fibrillation and choosing to undergo a rhythm control strategy at Robert Packer Hospital with a BMI ≥ 27 will be eligible for the study. All subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

Individuals who are already taking metformin or other antidiabetic medications including insulin, have a diagnosis of diabetes, have a known allergy or FDA-labeled contraindication to taking metformin, eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease,, have acute or chronic metabolic acidosis (serum bicarbonate <22 mEq/L), have a history of significant alcohol use (>2 drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5X greater than the upper limit of normal), have a history of New York Heart Association (NYHA) Class III or IV heart failure, or are pregnant will be excluded from the trial.
Intervention: Metformin
Trial phase: Phase 3
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
Healthy volunteers: No
Participants at risk: 397
Group description: Metformin 1000 mg twice a day
Eligibility criteria:
Inclusion Criteria:

Maternal age 18-45 years
Singleton pregnancy with no known fetal anomalies
Gestational age between 10weeks 0 days and 22 weeks 6 days by menstrual dating confirmed by ultrasound, or ultrasound alone
Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent or insulin)
Clinical diagnosis of diabetes diagnosed between 10 weeks and < 20 weeks 6 days gestation
Willing to start insulin therapy and discontinue oral hypoglycemic pills other than study pills
Able to swallow pills

Exclusion Criteria:

Clinical diagnosis of pre-existing renal disease, defined as creatinine > 1.5 mg/dL
Clinical history of lactic acidosis
Known allergy to metformin
Participation in another study that could affect primary outcome
Delivery planned at non-MOMPOD study locations
Unwillingness to use insulin treatment or follow prenatal care doctor's instructions for insulin and blood glucose monitoring
Intervention: Vortioxetine
Trial phase: Phase 4
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 91
Group description: Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
Eligibility criteria:
Inclusion Criteria:

Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.
Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and Baseline Visits.
If female, has a regular menstrual cycle.
Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and Baseline Visits.
If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.

Exclusion Criteria:

Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a history of depression or any other psychiatric illness.
Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
If female, has polycystic ovarian syndrome.
Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Intervention: Vortioxetine
Trial phase: Phase 4
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 91
Group description: Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.
Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and Baseline Visits.
If female, has a regular menstrual cycle.
Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and Baseline Visits.
If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.

Exclusion Criteria:

Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a history of depression or any other psychiatric illness.
Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
If female, has polycystic ovarian syndrome.
Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Intervention: Ivacaftor
Trial phase: Phase 3
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: There is only one arm to this study. The two sisters with Cystic Fibrosis will both receive Ivacaftor for 6 months for their treatment.

Ivacaftor: Subjects will be treated with ivacaftor for 6 months and followed for 7 months and will undergo assessments along the way to measure sweat chloride and sputum amounts.
Eligibility criteria:
Inclusion Criteria:

Subjects are >18 years of age and able to provide informed consent.
Subjects reside in the US and are willing to be treated with ivacaftor.
Subjects have the splicing mutation of interest.
Subjects are willing and able to perform requirements of the study.

Exclusion Criteria:

There are no relevant exclusion criteria for this n-of-2 study.