anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ivabradine
Trial phase: Phase 3
ATC code: C01EB17 | C07FX05 | C07FX06
SMILES: COc1cc2c(cc1OC)CC(=O)N(CCCN(C)C[C@H]1Cc3cc(OC)c(OC)cc31)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Patient will consume one dose of Ivabradine twice a day for one month.

Ivabradine: Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
Eligibility criteria:
Inclusion Criteria:

Subjects aged 18-65.
Subjects must have POTS diagnosis (Hyperadrenergic Subtype with NE> 600pg/ml))
Subjects with no structural heart disease
Subject with no arrhythmias
Subjects with norepinephrine levels greater than 600 pg/ml
Subjects with normal CBC, Metabolic, and thyroid levels

Exclusion Criteria:

Thyroid or adrenal disorders
Drugs that interfere with Ivabradine (example: Cytochrome P450 drugs)
Presentation of peripheral edema and discolored toes with peripheral autonomic neuropathy. Symptoms include: legs (reduced hair growth, cramps), toes (blue color), legs/feet (wounds, ulcers that do not heal), and muscles (numbness, heaviness)
Subjects who have had a history of systemic illnesses (acute or chronic infectious); autoimmune/ inflammatory disease, cancer, COPD, anemia, diabetes, or psychiatric illness
Subjects with resting heart rate< 60beats/min, atrial fibrillation, advanced AV blocks, sinus disease, and acute decompensated heart failure and severe hepatic impairment.
Smokers or alcohol abuse
Pregnant or breastfeeding mothers
Woman of childbearing potential who are unwilling to use highly effective contraception during treatment and for an additional one month after discontinuing the study drug
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: 76
Group description: Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group

Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
Eligibility criteria:
Inclusion Criteria:

Male or Female
18 years of age or older
patients scheduled for elective colorectal, pancreatic, and other major abdominal procedure.
Patient consent will be obtained preoperatively for eligible study participants.

Exclusion Criteria:

Patients who refuse to participate in the study or part of any other enhanced recovery after surgery (ERAS) research protocol.
Patients with a documented allergy to acetaminophen.
Chronic alcoholism
Hypovolemia
Chronic malnutrition
Preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis
Patients with a history of hepatic impairment, history of hepatic impairment or active hepatic disease
severe chronic pain condition that required daily preoperative opioid dependence
Patients with pre-existing dementia and/or other neuropsychiatric conditions impeding accurate assessment of pain scores or other study measures will be excluded.
Intervention: Perflutren
Trial phase: Not Applicable
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping.

Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]: Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia.
Eligibility criteria:
Inclusion Criteria:

Subject is 18 years of age or older
Subject is undergoing catheter ablation of likely reentrant VT
Planned use of intracardiac echocardiography (ICE)
Subject is willing to sign and date the study informed consent form

Exclusion Criteria:

Contraindication to Perflutren (Optison) echo contrast
Known right-to-left, bidirectional, or transient right-to-left cardiac shunts
Known hypersensitivity to Perflutren, blood, blood products or albumin
Subject has medical condition that would limit study participation (as per MD discretion)
Subject is pregnant
Inability to give informed consent
Intervention: Latanoprost
Trial phase: Phase 2
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: 44
Group description: 0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Provide signed written informed consent
Diagnosis of POAG or OHT in both eyes
Qualifying corrected visual acuity in each eye
Qualifying central corneal thickness in each eye
Qualifying Day 1 IOP measurement at 3 time-points in both eyes
Qualifying Anterior chamber angle

Exclusion Criteria:

History of ocular surgery specifically intended to lower IOP
Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
Advanced glaucoma in either eye
Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye
Females who are pregnant, nursing, or planning a pregnancy
Intervention: Rimegepant
Trial phase: Phase 3
ATC code: N02CD06
SMILES: N[C@@H]1c2cccnc2[C@H](OC(=O)N2CCC(n3c(=O)[nH]c4ncccc43)CC2)CC[C@H]1c1cccc(F)c1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 546
Group description: Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Eligibility criteria:
Key Inclusion Criteria:

Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version[1] including the following:

Not more than 8 attacks of moderate or severe intensity per month within last 3 months
Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

Patient history of HIV disease
Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal-absorption
The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
Intervention: Rimegepant
Trial phase: Phase 3
ATC code: N02CD06
SMILES: N[C@@H]1c2cccnc2[C@H](OC(=O)N2CCC(n3c(=O)[nH]c4ncccc43)CC2)CC[C@H]1c1cccc(F)c1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 543
Group description: Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Eligibility criteria:
Key Inclusion Criteria:

Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version[1] including the following:

Not more than 8 attacks of moderate or severe intensity per month within last 3 months
Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

Patient history of HIV disease
Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption.
The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitisB or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course ofthe trial
History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within thepast 12 months from the date of the screening visit.
Intervention: Enobosarm
Trial phase: Phase 2
SMILES: C[C@](O)(COc1ccc(C#N)cc1)C(=O)Nc1ccc(C#N)c(C(F)(F)F)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.

GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
Eligibility criteria:
Key Inclusion Criteria:

SUI symptoms of at least 6 months duration
Predominant SUI as determined at the Screening Visit using the Medical, Epidemiological, and Social Aspects of Aging (MESA) urinary questionnaire.
24-Hour pad weight > 3 g during the screening period
A minimum of 1 and no more than 15 SUI episodes on any single day AND no fewer than 9 total SUI episodes over 3 days during the screening period
Positive bladder stress test conducted during the Screening Visit

Key Exclusion Criteria:

History of pelvic radiation treatment
History of urethral diverticula
History of urethral sling or anterior prolapse repair
Treatment with urethral bulking agents and/or other SUI procedure or surgery within the 6 months prior to the Screening Visit
Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities
Urinary incontinence of neurogenic etiology
Morbidly obese (defined as 100 pounds over ideal body weight, or body mass index 40 or greater)
Chronic hepatitis
Hepatic cirrhosis
Evidence of active infection with hepatitis B or hepatitis C
History of human immunodeficiency virus (HIV) infection
Subjects with a history of breast or endometrial cancer
Intervention: Morphine sulfate pentahydrate
Trial phase: Phase 4
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: 5 micrograms/kilogram of intrathecal morphine.
Eligibility criteria:
Inclusion Criteria:

• patient undergoing elective robotic myocardial revascularization without anticipated use of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation.

Exclusion Criteria:

Emergency surgery
Preoperative use of inotropes/IABP
Preoperative use of opoids
Ejection fraction less than 40%
Anticipated use of cardiopulmonary bypass
Previous cardiothoracic surgery
Anticipated postoperative tracheal intubation
severe pulmonary disease
morbid obesity (BMI >35 kg/m2)
severe hepatic impairment
severe renal dysfunction (creatinine > 1.5)
any contraindication to intrathecal injection (patient refusal, difficult patient anatomy, pre-existing coagulopathy, morphine allergy)
Intervention: Fingolimod
Trial phase: Phase 4
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
Eligibility criteria:
Inclusion Criteria:

Diagnosis of relapsing forms of Multiple Sclerosis
Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years

Exclusion Criteria (per USPI):

Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker
Baseline QTc interval ≥ 500 msec
Treatment with Class Ia or Class III anti-arrhythmic drugs
Patients who had a hypersensitivity reaction to fingolimod or any of the excipients
Intervention: Fingolimod
Trial phase: Phase 4
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 217
Group description: RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
Eligibility criteria:
Inclusion Criteria:

Diagnosis of relapsing forms of Multiple Sclerosis
Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years

Exclusion Criteria (per USPI):

Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker
Baseline QTc interval ≥ 500 msec
Treatment with Class Ia or Class III anti-arrhythmic drugs
Patients who had a hypersensitivity reaction to fingolimod or any of the excipients
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
Healthy volunteers: No
Participants at risk: 114
Group description: Highest risk pre-diabetic patients

Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.

The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.

Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.
Eligibility criteria:
Inclusion Criteria:

BMI>25 or WC>88/102cm
No history of type I or type II diabetes or gestational diabetes
Not on blood sugar altering medication
Ability to attend weekly sessions
HbA1c 6-6.4%

Exclusion Criteria:

Pregnant
eGFR<45 mL/min/1.73 m2
Prescribed Metformin and randomized to the control arm
Intervention: 6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide
Trial phase: Phase 1
SMILES: O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants received SAD of 100 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.
Eligibility criteria:
Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.
Intervention: 6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide
Trial phase: Phase 1
SMILES: O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants received SAD of 200 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.
Eligibility criteria:
Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.