anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Colchicine
Trial phase: Phase 4
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Colchicine, 0.6 mg tablet, orally, twice daily, from Days 5-18.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non smoking and non-pregnant (postmenopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive; hemoglobin greater than or equal to 11.5g/dL

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or donation of plasma
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
Subjects who test positive for drugs of abuse or alcohol at screening or check-in
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease or active sexually transmitted disease
History of neuropathy or muscle disorders, peptic ulcer disease, clinically significant cardiac arrhythmias, seizure disorder, and low white blood cell count or other bone marrow disorders
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
History of allergy or sensitivity to colchicine or theophylline or aminophylline
Subjects who have had a tattoo or body piercing within 30 days prior to administration of study drug
Subjects with irritable bowel syndrome, chronic diarrhea or other chronic gastro-intestinal problems
Subjects who are lactose intolerant
Intervention: Promega
Trial phase: Phase 1 | Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Omegaven: 1 g/kg/d iv infusion over 24h
Eligibility criteria:
Inclusion Criteria:

Cholestasis defined as either

serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis

Exclusion Criteria:

Age > 1y at time that omegaven is started
Not expected to survive at least 30 days
Fish allergy in a first degree relative
Hemodynamic instability
Coagulopathy
Not likely to require PN for > 30d
Not expected to survive > 30d
Intervention: Tyrosine
Trial phase: Phase 2
SMILES: N[C@@H](Cc1ccc(O)cc1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: [F-18]RDG-K5 was administred and PET scan performed
Eligibility criteria:
Inclusion Criteria:

Participant is a female or male of any race / ethnicity >18 years old at the time of the investigational product administration
Participant or participant's legally acceptable representative provides written informed consent
Participant is capable of complying with study procedures
Participant has known carotid artery stenosis of >69% luminal diameter as based on carotid ultrasound and who is deemed to be a surgical candidate for endarterectomy as determined by the vascular surgeon
Participant has had a carotid ultrasound and the report is available for collection
Participant has had or is scheduled to have a carotid CT angiogram for plaque localization within 30 days of signing ICF (or else scheduled Carotid CT angiogram) CTA must be performed on a separate day and prior to the investigational PET procedure)
Participant has consented to have an endarterectomy
Participant will be scheduled for an investigational [F-18]RGD-K5 PET/CT scan within 4 weeks prior to endarterectomy
Participant must have renal function values as defined by laboratory results within the following ranges:
Serum creatinine ≤ 1.5 mg/dL
Estimated glomerular filtration rate (eGFR) ≥ 45mL/min

Exclusion Criteria:

Participant is nursing
Participant is pregnant
Participant has been involved in an investigative, radioactive research procedure within the past 14 days
Participant has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
Participant has a history or current evidence of any condition, therapy, lab abnormality that, in the opinion of the study investigator or treating physicians might confound the results of the study or poses an additional risk to the participants by their participation in the study
Intervention: Unii-T3B2aiz4BF
Trial phase: Phase 2
SMILES: CCC(C)C(NC(C)=O)C(=O)NC1CSSCC(C(=O)NC(C(N)=O)C(C)O)NC(=O)C(CCCNC(=N)N)NC(=O)C(Cc2c[nH]cn2)NC(=O)C(C)NC(=O)CNC(=O)C(Cc2c[nH]c3ccccc23)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(Cc2cn(C)c3ccccc23)NC(=O)C(C(C)C)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 1 intravitreal injection per month for up to 12 months
Eligibility criteria:
Inclusion Criteria:

Ability to provide informed consent and comply with the protocol.
Diagnosis of bilateral geographic atrophy (GA) of the macula secondary to age-related macular degeneration, confirmed within 14 days prior to randomization.
Study eye: Maximum best-corrected visual acuity (BCVA) of 55 letters (20/80 Snellen equivalent) and a minimum BCVA of 20 letters (20/400 Snellen equivalent) at screening
BCVA of 20 letters (20/400 Snellen equivalent) or better in the non treated eye at screening without conditions other than AMD that, in the opinion of the investigator, could cause a rapid loss of vision.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any history or current evidence of exudative ("wet") AMD in study eye.
Retinal disease other than AMD in the study eye.
Any ophthalmologic condition in study eye that reduces the clarity of the media and that, in the opinion of the Investigator interferes with ophthalmologic examination, such as advanced cataract or corneal abnormalities.
Any ophthalmologic condition in study eye that prevents adequate imaging of the retina judged by the site or reading center.
A history or current medical diagnosis of glaucoma or ocular hypertension in study eye.
Any ophthalmic condition in study eye that may require surgery during the study period.
Current ocular or periocular infection in the study eye.
History of any disease or current use of medication expected to cause systemic or ocular immunosuppression, such as RESTASIS®.
History of uveitis or endophthalmitis in the study eye.
History of intraocular surgery (including cataract surgery) in the study eye within 90 days prior to dosing.
History of intravitreal or periocular injection in the study eye at anytime.
Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 6 weeks or during active period of drug (whichever is longer) prior to the start of study treatment.
History of any medical or psychiatric condition, or substance abuse, that in the Investigator's opinion is likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.
Women of child bearing potential UNLESS they are using a highly effective method of birth control.
Known or suspected allergy or hypersensitivity to fluorescein or other injectables.
Other protocol-defined exclusion criteria may apply.
Intervention: Clopidogrel
Trial phase: Phase 4
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
Eligibility criteria:
Inclusion Criteria:

Provision of signed and dated informed consent before initiation of any study-related procedures
Male or female patients aged 18 years or older
Documented acute coronary syndrome and troponin negative and undergoing Ad Hoc percutaneous coronary intervention (PCI)
Females must be post menopausal or surgically sterile
Taking aspirin as an anti-platelet medication

Exclusion Criteria:

Use of any thienopyridine or ticagrelor within 7 days prior to randomization
Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve)
Contraindication that ticagrelor or clopidogrel should not be administered Patient requires dialysis
History of intolerance or allergy to aspirin
Intervention: Prednisone
Trial phase: Phase 3
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 65
Group description: daily prednisone (0.75 mg/kg/day)

Prednisone: daily prednisone (0.75 mg/kg/day) tablets for 36-60 months
Eligibility criteria:
Inclusion Criteria:

Evidence of signed and dated informed consent form.
Confirmed diagnosis of Duchenne muscular dystrophy
Age greater than or equal to 4 years and less than 8 years old
Ability to rise independently from floor, from supine to standing
Willingness and ability to comply with scheduled visits, drug administration plan and study procedures
Ability to maintain reproducible FVC measurements.

Exclusion Criteria:

History of major renal or hepatic impairment, immunosuppression or other contraindications to corticosteroid therapy.
History of chronic systemic fungal or viral infections. Acute bacterial infection(including TB) would exclude from enrolment until the infection had been appropriately treated and resolved.
Diabetes mellitus.
Idiopathic hypercalcuria.
Lack of chicken pox immunity and refusal to undergo immunization.
Evidence of symptomatic cardiomyopathy at screening assessment (one to three months prior to the baseline visit). Asymptomatic cardiac abnormality on investigation would not be an exclusion.
Current or previous treatment (greater than four consecutive weeks of oral therapy) with corticosteroids or other immunosuppressive treatments for DMD or other recurrent indications (e.g., asthma), unless approved by FOR-DMD Team (i.e., concurrent participation in another allowed DMD trial).
Inability to take tablets, as assessed by the site investigator by the end of the screening period (the screening period ranges from one to three months prior to the baseline visit).
Allergy/sensitivity to study drugs or their formulations including lactose and/or sucrose intolerance.
Severe behavioral problems, including severe autism.
Previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow up will be correctly completed or impair the assessment of study results, in the judgment of the site investigator.
Weight of less than 13 kilograms.
Exposure to any investigational drug currently or within 3 months prior to start of study treatment.
Intervention: Deflazacort
Trial phase: Phase 3
ATC code: H02AB13
SMILES: [H][C@@]12C[C@@]3([H])OC(C)=N[C@@]3(C(=O)COC(C)=O)[C@@]1(C)C[C@]([H])(O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 65
Group description: daily deflazacort (0.9 mg/kg/day

Deflazacort: daily deflazacort (0.9 mg/kg/day) tablets for 36-60 months
Eligibility criteria:
Inclusion Criteria:

Evidence of signed and dated informed consent form.
Confirmed diagnosis of Duchenne muscular dystrophy
Age greater than or equal to 4 years and less than 8 years old
Ability to rise independently from floor, from supine to standing
Willingness and ability to comply with scheduled visits, drug administration plan and study procedures
Ability to maintain reproducible FVC measurements.

Exclusion Criteria:

History of major renal or hepatic impairment, immunosuppression or other contraindications to corticosteroid therapy.
History of chronic systemic fungal or viral infections. Acute bacterial infection(including TB) would exclude from enrolment until the infection had been appropriately treated and resolved.
Diabetes mellitus.
Idiopathic hypercalcuria.
Lack of chicken pox immunity and refusal to undergo immunization.
Evidence of symptomatic cardiomyopathy at screening assessment (one to three months prior to the baseline visit). Asymptomatic cardiac abnormality on investigation would not be an exclusion.
Current or previous treatment (greater than four consecutive weeks of oral therapy) with corticosteroids or other immunosuppressive treatments for DMD or other recurrent indications (e.g., asthma), unless approved by FOR-DMD Team (i.e., concurrent participation in another allowed DMD trial).
Inability to take tablets, as assessed by the site investigator by the end of the screening period (the screening period ranges from one to three months prior to the baseline visit).
Allergy/sensitivity to study drugs or their formulations including lactose and/or sucrose intolerance.
Severe behavioral problems, including severe autism.
Previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow up will be correctly completed or impair the assessment of study results, in the judgment of the site investigator.
Weight of less than 13 kilograms.
Exposure to any investigational drug currently or within 3 months prior to start of study treatment.
Intervention: Prednisone
Trial phase: Phase 3
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 66
Group description: intermittent prednisone (0.75 mg/kg/day, 10 days on, 10 days off)

Prednisone: intermittent prednisone (0.75 mg/kg/day, 10 days on, 10 days off) tablets for 36 to 60 months
Eligibility criteria:
Inclusion Criteria:

Evidence of signed and dated informed consent form.
Confirmed diagnosis of Duchenne muscular dystrophy
Age greater than or equal to 4 years and less than 8 years old
Ability to rise independently from floor, from supine to standing
Willingness and ability to comply with scheduled visits, drug administration plan and study procedures
Ability to maintain reproducible FVC measurements.

Exclusion Criteria:

History of major renal or hepatic impairment, immunosuppression or other contraindications to corticosteroid therapy.
History of chronic systemic fungal or viral infections. Acute bacterial infection(including TB) would exclude from enrolment until the infection had been appropriately treated and resolved.
Diabetes mellitus.
Idiopathic hypercalcuria.
Lack of chicken pox immunity and refusal to undergo immunization.
Evidence of symptomatic cardiomyopathy at screening assessment (one to three months prior to the baseline visit). Asymptomatic cardiac abnormality on investigation would not be an exclusion.
Current or previous treatment (greater than four consecutive weeks of oral therapy) with corticosteroids or other immunosuppressive treatments for DMD or other recurrent indications (e.g., asthma), unless approved by FOR-DMD Team (i.e., concurrent participation in another allowed DMD trial).
Inability to take tablets, as assessed by the site investigator by the end of the screening period (the screening period ranges from one to three months prior to the baseline visit).
Allergy/sensitivity to study drugs or their formulations including lactose and/or sucrose intolerance.
Severe behavioral problems, including severe autism.
Previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow up will be correctly completed or impair the assessment of study results, in the judgment of the site investigator.
Weight of less than 13 kilograms.
Exposure to any investigational drug currently or within 3 months prior to start of study treatment.
Intervention: Losartan
Trial phase: Phase 4
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: This group will receive 100 mg of losartan per day. Amlodipine will be maintained.

Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Ambulatorial patients with age between 40 and 70 years-old.
Systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks.
Type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. Glycated hemoglobin A1c less than 9.0%.
Accepted the consent form.

Exclusion Criteria:

Office systolic blood pressure equal or more than 180 mmHg, with or without treatment
Office diastolic blood pressure equal or more than 110 mmHg, with or without treatment
Evidences of a secondary cause for hypertension
Glycated hemoglobin A1c > 9.0%
Insulin therapy
Chronic kidney disease stage 4 or 5 or in dialysis
Advanced target organ lesion, obtained by history or additional exams, and defined by: previous myocardial infarction, heart failure with ejection fraction less than 40%, cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease (claudication or doppler with obstruction > 50% of vascular lumen), retinopathy with visual loss, symptomatic neuropathy.
Cardiac arrhythmias, except for ectopic beats
Any clinical or disabling condition that, in the opinion of the investigators, may confound or prejudice study results.
Severe mitral regurgitation.
Women in fertile age without contraceptive methods in use.
Breastfeeding women.
Intervention: Benazepril
Trial phase: Phase 4
ATC code: C09AA07 | C09BA07 | C09BB13
SMILES: [H][C@]1(N[C@@H](CCc2ccccc2)C(=O)OCC)CCc2ccccc2N(CC(=O)O)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.

Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Ambulatorial patients with age between 40 and 70 years-old.
Systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks.
Type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. Glycated hemoglobin A1c less than 9.0%.
Accepted the consent form.

Exclusion Criteria:

Office systolic blood pressure equal or more than 180 mmHg, with or without treatment
Office diastolic blood pressure equal or more than 110 mmHg, with or without treatment
Evidences of a secondary cause for hypertension
Glycated hemoglobin A1c > 9.0%
Insulin therapy
Chronic kidney disease stage 4 or 5 or in dialysis
Advanced target organ lesion, obtained by history or additional exams, and defined by: previous myocardial infarction, heart failure with ejection fraction less than 40%, cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease (claudication or doppler with obstruction > 50% of vascular lumen), retinopathy with visual loss, symptomatic neuropathy.
Cardiac arrhythmias, except for ectopic beats
Any clinical or disabling condition that, in the opinion of the investigators, may confound or prejudice study results.
Severe mitral regurgitation.
Women in fertile age without contraceptive methods in use.
Breastfeeding women.
Intervention: Propofol
Trial phase: Phase 2 | Phase 3
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Propofol at subanesthetic dose via IV push

Propofol: Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses
Eligibility criteria:
Inclusion Criteria:

Children 7-18 years of age
Acute Migraine Headache

Exclusion Criteria:

Head Trauma
CNS infection
CNS tumor
Previous CNS surgery or device
Intervention: Nebivolol
Trial phase: Phase 4
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.

Nebivolol: Nebivolol 2.5 mg once daily
Eligibility criteria:
All candidates must have previously untreated hypertension. The candidates will be picked from patients with stage-1 hypertension (systolic BP 140-159 mm Hg or diastolic BP 90-99 mm Hg) and those with stage-2 hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥100), based on the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines (JNC-7).

Inclusion Criteria:

Presence of inappropriate LVM.
Presence of phenotype of inappropriate LVM.

Exclusion Criteria:

The criteria will assure that only patients with hypertension are enrolled, that is, excluded will be subjects with systolic BP < 140 or diastolic BP < 90 (ie, prehypertension or normal BP), but without complications or any indication (or suspicion) of end-organ damage based on a physical exam, clinical history, or laboratory tests.

Specific exclusion criteria are:

Reactive airways disease including asthma.
Diabetes mellitus or hypoglycemia; thyrotoxicosis.
LV dysfunction (ejection fraction < 50%) or heart failure.
Present or previously documented coronary heart disease or angina.
Acute myocardial infarction, or history of myocardial infarction.
Severe bradycardia, heart block greater than first degree or sick sinus syndrome (unless a permanent pacemaker is in place).
Hepatic insufficiency or history of cirrhosis.
Chronic renal failure or renovascular dysfunction.
Cerebrovascular dysfunction.
Peripheral vascular disease.
Pregnant or nursing women; women of childbearing age will be required to take a pregnancy test at the time of enrollment and use an acceptable method of birth control.
Poor echo image quality.