anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sotagliflozin
Trial phase: Phase 3
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 605
Group description: Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
Eligibility criteria:
Inclusion criteria:

Type 2 Diabetes Mellitus.
Admitted to the hospital, or urgent heart failure visit for worsening heart failure.
Prior diagnosis of heart failure (> 3 months).
Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for > 30 days.
Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge.
Brain natriuretic peptide (BNP) ≥150 picograms per milliliter (pg/mL) (≥450 pg/mL for participants with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for participants with atrial fibrillation).
Participants with Left Ventricular Ejection Fraction <40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated.
Signed written informed consent.

Exclusion criteria:

Age < 18 years or > 85 years.
Worsening heart failure attributed to other causes such as pulmonary embolism, stroke, heart attack.
Cardiac surgery or coronary procedure within 1 month or planned during study.
Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.
Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.
Acute coronary syndromes within 3 months prior to Randomization.
Hemodynamically significant uncorrected primary valvular disease.
Significant pulmonary disease contributing substantially to the participant's dyspnea.
End stage Heart Failure.
History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 months prior to screening.
History of stroke within 3 months prior to randomization.
History of dialysis within 1 year prior to randomization.
History of solid organ transplant or on a transplant list (if heart transplant, defined as status 1 transplant).
Severe kidney disease as defined by glomerular filtration rate (eGFR) <30 milliliter per minute per 1.72 meter square (mL/min/1.73 m^2).
Pregnancy.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Clindamycin
Trial phase: Phase 3
ATC code: D10AF01 | D10AF51 | G01AA10 | J01FF01
SMILES: [H][C@]1([C@]([H])(NC(=O)[C@@H]2C[C@@H](CCC)CN2C)[C@H](C)Cl)O[C@H](SC)[C@H](O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1125
Group description: Clindamycin 1% Gel: Topical gel
Eligibility criteria:
IInclusion Criteria:

Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria:

Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
Subject has active cystic acne.
Subject has acne conglobata.
Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 79
Group description: Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes.

Ferric carboxymaltose: Intravenous iron
Eligibility criteria:
Inclusion Criteria:

Male or female participants 1 to 17 years of age with assent to participation and his/her parent or guardian is willing and able to sign the informed consent approved by the Independent Review Board / Ethics Committee.
Screening Hgb <11 g/dL.
Screening ferritin ≤300 ng/mL and transferrin saturation (TSAT) <30%.
Participants must have a documented history of an inadequate response to any oral iron therapy for at least 8 weeks (56 days) prior to randomization.
For participants who are receiving an erythropoietin stimulating agent (ESA): stable ESA therapy (+/- 20% of current dose) for at least 8 weeks prior to the qualifying screening visit and no ESA dosing or product changes anticipated for the length of the trial.
Participants undergoing treatment for inflammatory bowel disease (IBD) must be on stable therapy for at least 8 weeks prior to consent.

Exclusion Criteria:

Known history of hypersensitivity reaction to any component of FCM.
Previous randomization and treatment in this study or any other clinical study of FCM or VIT-45.
History of acquired iron overload, hemochromatosis, or other iron accumulation disorders.
Chronic kidney disease participants on hemodialysis.
History of significant diseases of the liver, hematopoietic system, cardiovascular system, psychiatric disorder, or other conditions which, on the opinion of the investigator, may place a subject at added risk for participation in the study.
Any existing non-viral infection.
Known history of positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis.
Known history of positive HIV-1/HIV-2 antibodies (anti-HIV).
Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy and vitamin B12 or folic acid deficiency) that has not been corrected.
Intravenous iron and /or blood transfusion in the 4 weeks prior to consent.
Administration and / or use of an investigational product (drug or device) within 30 days of screening.
Alcohol or drug abuse within the past six months.
Female participant who is pregnant or lactating, or sexually active female who are of childbearing potential not willing to use an acceptable form of contraceptive precautions during the study.
Unable to comply with study procedures and assessments
Intervention: Docusate
Trial phase: Phase 4
SMILES: CCCCC(CC)COC(=O)CC(C(=O)OCC(CC)CCCC)S(=O)(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 77
Group description: The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.

Docusate Sodium: Oral docusate sodium twice daily
Eligibility criteria:
Inclusion Criteria:

Female patients seen in the Gynecology or Urogynecology clinics at LAC+USC Medical Center who are planned for surgery requiring at least 24 hour stay
Age 18 or greater
Able to give informed consent
No contraindications to docusate or prune consumption

Exclusion Criteria:

Unable to give informed consent
Unwilling to follow protocol
Active malignancy
Emergency surgery
Diabetes mellitus
Inflammatory bowel disease, gastroparesis, or other bowel disorder
History of bowel resection or presence of colostomy
Dependence on regular laxative use prior to surgery
Baseline frequency of bowel movements less than weekly
Intraoperative enterotomy or any bowel surgery performed at the time of surgery
Patient unable to initiate oral intake on post op day 1 for any reason
Allergy to docusate or prunes
Intervention: Pibrentasvir
Trial phase: Phase 2
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.

Mavyret: Patients will be on 8 weeks of Mavyret
Eligibility criteria:
Inclusion Criteria:

Recipient criteria:

Listed for an isolated lung transplant at NYU Langone Health
Between 18-70 years of age
Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
No active illicit substance abuse
Weight at least 40kg
Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage
Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange
Able and willing to provide informed consent

Donor criteria:

Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody
Donor lung meets standard NYU Langone Health clinical criteria for procurement

Exclusion Criteria:

Recipient criteria:

HIV positive
HCV RNA positive or history of previously treated HCV
Evidence of active hepatitis B infection or on active antiviral treatment for HBV
Pregnant or nursing (lactating) women
Use of strong CYP3A inducers
Requires multi-organ transplant

Donor criteria:

Confirmed HIV positive
Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable Hepatitis B virus DNA)
Known previously failed treatment for HCV
Donor age >60 years
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment

Ibuprofen: Ibuprofen gel capsule
Eligibility criteria:
Inclusion Criteria:

-Orthodontic patient presenting for orthodontic treatment

Exclusion Criteria:

History of taking an analgesic in the past six hours
Hypersensitivity to ibuprofen or acetaminophen
Aspirin-sensitive asthma
Renal or liver impairment
History of GI bleeding or ulcers
Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery
Currently taking antibiotics or other medications for a chronic systemic disease
Bleeding disorder
Pregnant or nursing
Intervention: Tamsulosin
Trial phase: Phase 2 | Phase 3
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 57
Group description: Tamsulosin: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
Eligibility criteria:
Inclusion Criteria:

Patients must be 18 years or older as well as willing and able to provide informed consent
Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.

Exclusion Criteria:

Patient unable or unwilling to provide informed consent
Severe allergy to sulfa drugs
Known allergy to tamsulosin or another alpha antagonist medication
History of urinary retention
Planned bladder catheterization greater than 24 hours after surgery
Current use of alpha antagonist medication for hypertension
End stage renal or liver disease
Intervention: Eltrombopag
Trial phase: Phase 2
ATC code: B02BX05
SMILES: CC1=NN(c2ccc(C)c(C)c2)C(=O)/C1=N\Nc1cccc(-c2cccc(C(=O)O)c2)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Participants were treated with eltrombopag to induce sustained response off treatment to reach a target platelet count of >=100×10^9/L (CR), after 1st line steroids had failed.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Patients ≥ 18 years old
Patients with a confirmed diagnosis of primary ITP, who are not responsive or in relapse after a first line of steroid therapy ± intravenous immunoglobulin (IVIG) (used as a rescue therapy)
Platelet count < 30×10^9/L and assessed as needing treatment (per physician's discretion

Exclusion Criteria:

ITP patients previously treated with any ITP second-line therapies, thrombopoietin receptor (TPO-R) agonists for ITP, except steroids / IVIG
Patients who relapsed more than one year after the end of first-line full course of steroid therapy
Patients with a diagnosis of secondary thrombocytopenia
Patients who have life threatening bleeding complications per investigator discretion
Patients who had a deep vein thrombosis or arterial thrombosis in the 6 months preceding enrollment
Serum creatinine ≥ 1.5 mg/dL
Total bilirubin > 1.5 × upper limit of normal (ULN)
Aspartate transaminase (AST) > 3.0 × ULN
Alanine transaminase (ALT) > 3.0 × ULN
Patients who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive
Patients with hepatic impairment (Child-Pugh score > 5)
Patients who have active malignancy
Patients with any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study procedures per investigator discretion
History or current diagnosis of cardiac disease indicating significant risk of safety for Patients participating in the study
Patients with known active or uncontrolled infections not responding to appropriate therapy
Patients with evidence of current alcohol/drug abuse
Women of child-bearing potential and sexually active males unwilling to use adequate contraception during the study
Female Patients who are nursing or pregnant (positive serum or urine B-human chorionic gonadotrophin (B-hCG) pregnancy test) at screening or pre-dose on Day 1

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Everolimus
Trial phase: Phase 4
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Participants targeted to receive Everolimus tablets 10 mg once daily for 48 weeks.
Eligibility criteria:
Inclusion Criteria:

Eligible for treatment with everolimus as per the locally approved label.
Presence of at least one AML ≥ 3 cm in its longest diameter using CT or MRI.

Exclusion Criteria:

AML related bleeding or embolization during the 6 months prior to enrollment.
History of myocardial infarction, angina or stroke related to atherosclerosis.
Impaired lung function.
Significant hematological or hepatic abnormality.
Any severe and/or uncontrolled medical conditions.
Intervention: Crinecerfont
Trial phase: Phase 2
SMILES: C#CCN(c1nc(-c2cc(C)c(OC)cc2Cl)c(C)s1)[C@@H](CC1CC1)c1ccc(C)c(F)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Be in good general health.
Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH.
Be on a stable regimen of steroidal treatment for CAH that is expected to remain stable throughout the study.
Subjects of childbearing potential must be instructed on the proper use of barrier methods of contraception and agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently from screening until the final study visit or a prespecified window after the last dose of study drug, whichever is longer.
Subjects of childbearing potential must have a negative pregnancy test at screening and negative urine pregnancy test at baseline.
Have a negative urine drug (for illegal drugs) and alcohol breath test at screening and baseline.
Be willing and able to adhere to the study regimen and study procedures described in the protocol and informed consent/assent form, including all requirements at the study center and return for the follow-up visit.
Be willing to provide authorization for access to personal health information in conjunction with US Health Insurance Portability and Accountability Act (HIPAA).

Exclusion Criteria:

Have a clinically significant unstable medical condition or chronic disease, or malignancy.
Had a medically significant illness within 30 days of screening.
Have a known or suspected differential diagnosis of any of the other known forms of classic CAH.
Have a history that includes bilateral adrenalectomy, hypopituitarism, or other condition requiring daily therapy with orally administered glucocorticoids.
Are pregnant or lactating females.
Have a history of epilepsy or serious head injury.
Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
Have hypersensitivity to any corticotropin releasing hormone antagonists.
Test positive at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), or have a history of a positive result.
Have a recent history (≤1 year) of alcohol or drug abuse, or current evidence of substance dependence or abuse criteria.
Used any anticoagulants or antiplatelet therapies within 30 days before screening.
Have an active bleeding disorder.
Used any other investigational drug within 30 days before initial screening, or plans to use an investigational drug (other than the study drug) during the study.
Have a blood loss ≥550 mL or donated blood within 56 days or donated plasma within 7 days before baseline.
Intervention: Crinecerfont
Trial phase: Phase 2
SMILES: C#CCN(c1nc(-c2cc(C)c(OC)cc2Cl)c(C)s1)[C@@H](CC1CC1)c1ccc(C)c(F)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Be in good general health.
Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH.
Be on a stable regimen of steroidal treatment for CAH that is expected to remain stable throughout the study.
Subjects of childbearing potential must be instructed on the proper use of barrier methods of contraception and agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently from screening until the final study visit or a prespecified window after the last dose of study drug, whichever is longer.
Subjects of childbearing potential must have a negative pregnancy test at screening and negative urine pregnancy test at baseline.
Have a negative urine drug (for illegal drugs) and alcohol breath test at screening and baseline.
Be willing and able to adhere to the study regimen and study procedures described in the protocol and informed consent/assent form, including all requirements at the study center and return for the follow-up visit.
Be willing to provide authorization for access to personal health information in conjunction with US Health Insurance Portability and Accountability Act (HIPAA).

Exclusion Criteria:

Have a clinically significant unstable medical condition or chronic disease, or malignancy.
Had a medically significant illness within 30 days of screening.
Have a known or suspected differential diagnosis of any of the other known forms of classic CAH.
Have a history that includes bilateral adrenalectomy, hypopituitarism, or other condition requiring daily therapy with orally administered glucocorticoids.
Are pregnant or lactating females.
Have a history of epilepsy or serious head injury.
Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
Have hypersensitivity to any corticotropin releasing hormone antagonists.
Test positive at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), or have a history of a positive result.
Have a recent history (≤1 year) of alcohol or drug abuse, or current evidence of substance dependence or abuse criteria.
Used any anticoagulants or antiplatelet therapies within 30 days before screening.
Have an active bleeding disorder.
Used any other investigational drug within 30 days before initial screening, or plans to use an investigational drug (other than the study drug) during the study.
Have a blood loss ≥550 mL or donated blood within 56 days or donated plasma within 7 days before baseline.
Intervention: Crinecerfont
Trial phase: Phase 2
SMILES: C#CCN(c1nc(-c2cc(C)c(OC)cc2Cl)c(C)s1)[C@@H](CC1CC1)c1ccc(C)c(F)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Be in good general health.
Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH.
Be on a stable regimen of steroidal treatment for CAH that is expected to remain stable throughout the study.
Subjects of childbearing potential must be instructed on the proper use of barrier methods of contraception and agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently from screening until the final study visit or a prespecified window after the last dose of study drug, whichever is longer.
Subjects of childbearing potential must have a negative pregnancy test at screening and negative urine pregnancy test at baseline.
Have a negative urine drug (for illegal drugs) and alcohol breath test at screening and baseline.
Be willing and able to adhere to the study regimen and study procedures described in the protocol and informed consent/assent form, including all requirements at the study center and return for the follow-up visit.
Be willing to provide authorization for access to personal health information in conjunction with US Health Insurance Portability and Accountability Act (HIPAA).

Exclusion Criteria:

Have a clinically significant unstable medical condition or chronic disease, or malignancy.
Had a medically significant illness within 30 days of screening.
Have a known or suspected differential diagnosis of any of the other known forms of classic CAH.
Have a history that includes bilateral adrenalectomy, hypopituitarism, or other condition requiring daily therapy with orally administered glucocorticoids.
Are pregnant or lactating females.
Have a history of epilepsy or serious head injury.
Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
Have hypersensitivity to any corticotropin releasing hormone antagonists.
Test positive at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), or have a history of a positive result.
Have a recent history (≤1 year) of alcohol or drug abuse, or current evidence of substance dependence or abuse criteria.
Used any anticoagulants or antiplatelet therapies within 30 days before screening.
Have an active bleeding disorder.
Used any other investigational drug within 30 days before initial screening, or plans to use an investigational drug (other than the study drug) during the study.
Have a blood loss ≥550 mL or donated blood within 56 days or donated plasma within 7 days before baseline.