anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tropifexor
Trial phase: Phase 2
SMILES: O=C(O)c1cc(F)c2nc(N3[C@@H]4CC[C@H]3C[C@@H](OCc3c(-c5ccccc5OC(F)(F)F)noc3C3CC3)C4)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: LJN452 10 mcg (Part A)
Eligibility criteria:
Inclusion Criteria:

male/female patients, 18 years or older
written informed consent
Part A and B patients : presence of NASH by histological evidence (liver biopsy obtained 2 years or less prior to randomization) with fibrosis level of F1, F2 or F3 (fibrosis in the absence of cirrhosis) and no diagnosis of chronic liver disease and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)
Part C patients: presence of NASH by histological evidence (liver biopsy obtained during the Screening period or 6 months or less prior to randomization) with fibrosis level of F2 or F3 and no diagnosis of chronic liver disease

And ( All Parts):

ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
Liver fat equal to or higher than 10% by MRI

Exclusion Criteria:

previous exposure to OCA
patients taking prohibited medications
patients taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 1 month before randomization: (for Part C patients, dose must be stable for at least 1 month prior to biopsy through Screening : anti- diabetic medications, insulin, beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control
pregnant or nursing (lactating) women
current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
uncontrolled diabetes mellitus
new use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide within 3 months of screening
presence of cirrhosis
hepatic decompensation or severe liver impairment
previous diagnosis of other forms of chronic liver disease
patients with contraindications to MRI imaging
Intervention: Tropifexor
Trial phase: Phase 2
SMILES: O=C(O)c1cc(F)c2nc(N3[C@@H]4CC[C@H]3C[C@@H](OCc3c(-c5ccccc5OC(F)(F)F)noc3C3CC3)C4)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: 30 micrograms of Tropifexor (Part A)
Eligibility criteria:
Inclusion Criteria:

male/female patients, 18 years or older
written informed consent
Part A and B patients : presence of NASH by histological evidence (liver biopsy obtained 2 years or less prior to randomization) with fibrosis level of F1, F2 or F3 (fibrosis in the absence of cirrhosis) and no diagnosis of chronic liver disease and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)
Part C patients: presence of NASH by histological evidence (liver biopsy obtained during the Screening period or 6 months or less prior to randomization) with fibrosis level of F2 or F3 and no diagnosis of chronic liver disease

And ( All Parts):

ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
Liver fat equal to or higher than 10% by MRI

Exclusion Criteria:

previous exposure to OCA
patients taking prohibited medications
patients taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 1 month before randomization: (for Part C patients, dose must be stable for at least 1 month prior to biopsy through Screening : anti- diabetic medications, insulin, beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control
pregnant or nursing (lactating) women
current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
uncontrolled diabetes mellitus
new use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide within 3 months of screening
presence of cirrhosis
hepatic decompensation or severe liver impairment
previous diagnosis of other forms of chronic liver disease
patients with contraindications to MRI imaging
Intervention: Tropifexor
Trial phase: Phase 2
SMILES: O=C(O)c1cc(F)c2nc(N3[C@@H]4CC[C@H]3C[C@@H](OCc3c(-c5ccccc5OC(F)(F)F)noc3C3CC3)C4)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: LJN452 60 mcg (Parts A+B)
Eligibility criteria:
Inclusion Criteria:

male/female patients, 18 years or older
written informed consent
Part A and B patients : presence of NASH by histological evidence (liver biopsy obtained 2 years or less prior to randomization) with fibrosis level of F1, F2 or F3 (fibrosis in the absence of cirrhosis) and no diagnosis of chronic liver disease and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)
Part C patients: presence of NASH by histological evidence (liver biopsy obtained during the Screening period or 6 months or less prior to randomization) with fibrosis level of F2 or F3 and no diagnosis of chronic liver disease

And ( All Parts):

ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
Liver fat equal to or higher than 10% by MRI

Exclusion Criteria:

previous exposure to OCA
patients taking prohibited medications
patients taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 1 month before randomization: (for Part C patients, dose must be stable for at least 1 month prior to biopsy through Screening : anti- diabetic medications, insulin, beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control
pregnant or nursing (lactating) women
current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
uncontrolled diabetes mellitus
new use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide within 3 months of screening
presence of cirrhosis
hepatic decompensation or severe liver impairment
previous diagnosis of other forms of chronic liver disease
patients with contraindications to MRI imaging
Intervention: Tropifexor
Trial phase: Phase 2
SMILES: O=C(O)c1cc(F)c2nc(N3[C@@H]4CC[C@H]3C[C@@H](OCc3c(-c5ccccc5OC(F)(F)F)noc3C3CC3)C4)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: 90 micrograms of Tropifexor (Parts A + B)
Eligibility criteria:
Inclusion Criteria:

male/female patients, 18 years or older
written informed consent
Part A and B patients : presence of NASH by histological evidence (liver biopsy obtained 2 years or less prior to randomization) with fibrosis level of F1, F2 or F3 (fibrosis in the absence of cirrhosis) and no diagnosis of chronic liver disease and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)
Part C patients: presence of NASH by histological evidence (liver biopsy obtained during the Screening period or 6 months or less prior to randomization) with fibrosis level of F2 or F3 and no diagnosis of chronic liver disease

And ( All Parts):

ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
Liver fat equal to or higher than 10% by MRI

Exclusion Criteria:

previous exposure to OCA
patients taking prohibited medications
patients taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 1 month before randomization: (for Part C patients, dose must be stable for at least 1 month prior to biopsy through Screening : anti- diabetic medications, insulin, beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control
pregnant or nursing (lactating) women
current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
uncontrolled diabetes mellitus
new use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide within 3 months of screening
presence of cirrhosis
hepatic decompensation or severe liver impairment
previous diagnosis of other forms of chronic liver disease
patients with contraindications to MRI imaging
Intervention: Tropifexor
Trial phase: Phase 2
SMILES: O=C(O)c1cc(F)c2nc(N3[C@@H]4CC[C@H]3C[C@@H](OCc3c(-c5ccccc5OC(F)(F)F)noc3C3CC3)C4)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: LJN452 140 mcg (Part C)
Eligibility criteria:
Inclusion Criteria:

male/female patients, 18 years or older
written informed consent
Part A and B patients : presence of NASH by histological evidence (liver biopsy obtained 2 years or less prior to randomization) with fibrosis level of F1, F2 or F3 (fibrosis in the absence of cirrhosis) and no diagnosis of chronic liver disease and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)
Part C patients: presence of NASH by histological evidence (liver biopsy obtained during the Screening period or 6 months or less prior to randomization) with fibrosis level of F2 or F3 and no diagnosis of chronic liver disease

And ( All Parts):

ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
Liver fat equal to or higher than 10% by MRI

Exclusion Criteria:

previous exposure to OCA
patients taking prohibited medications
patients taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 1 month before randomization: (for Part C patients, dose must be stable for at least 1 month prior to biopsy through Screening : anti- diabetic medications, insulin, beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control
pregnant or nursing (lactating) women
current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
uncontrolled diabetes mellitus
new use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide within 3 months of screening
presence of cirrhosis
hepatic decompensation or severe liver impairment
previous diagnosis of other forms of chronic liver disease
patients with contraindications to MRI imaging
Intervention: Tropifexor
Trial phase: Phase 2
SMILES: O=C(O)c1cc(F)c2nc(N3[C@@H]4CC[C@H]3C[C@@H](OCc3c(-c5ccccc5OC(F)(F)F)noc3C3CC3)C4)sc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: LJN452 200 mcg (Part C)
Eligibility criteria:
Inclusion Criteria:

male/female patients, 18 years or older
written informed consent
Part A and B patients : presence of NASH by histological evidence (liver biopsy obtained 2 years or less prior to randomization) with fibrosis level of F1, F2 or F3 (fibrosis in the absence of cirrhosis) and no diagnosis of chronic liver disease and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)
Part C patients: presence of NASH by histological evidence (liver biopsy obtained during the Screening period or 6 months or less prior to randomization) with fibrosis level of F2 or F3 and no diagnosis of chronic liver disease

And ( All Parts):

ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
Liver fat equal to or higher than 10% by MRI

Exclusion Criteria:

previous exposure to OCA
patients taking prohibited medications
patients taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 1 month before randomization: (for Part C patients, dose must be stable for at least 1 month prior to biopsy through Screening : anti- diabetic medications, insulin, beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control
pregnant or nursing (lactating) women
current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
uncontrolled diabetes mellitus
new use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide within 3 months of screening
presence of cirrhosis
hepatic decompensation or severe liver impairment
previous diagnosis of other forms of chronic liver disease
patients with contraindications to MRI imaging
Intervention: Midazolam
Trial phase: Phase 4
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.

Midazolam: Dose use according to the product technical sheet
Eligibility criteria:
Inclusion Criteria:

Patients with acute pulmonary edema with dyspnoea and anxiety

Exclusion Criteria:

Patients with known severe liver disease.
Patients with known severe renal disease.
Patients with expectation of death from other illness during the course of the trial.
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 56
Group description: The dose of morphine intravenously is of 2-4 mg which may be repeated until a total dose of 8 mg if the patient continue suffering from severe anxiety or distress caused by APE

Morphine: Dose use according to the product technical sheet
Eligibility criteria:
Inclusion Criteria:

Patients with acute pulmonary edema with dyspnoea and anxiety

Exclusion Criteria:

Patients with known severe liver disease.
Patients with known severe renal disease.
Patients with expectation of death from other illness during the course of the trial.
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Sugammadex 4mg/kg

sugammadex
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for open ventral hernia repair or open colectomy
ASA class I-III
18 years and older
Subjects with a body mass index (BMI) of <45kg/m2 and weight less than 150kg
Subjects who have given written informed consent

Exclusion Criteria:

Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker
Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance < 30 mL.min-1
Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction
Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia;
Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins or Rocuronium or any of its excipients
Subjects who have a contraindication to, Rocuronium or Sugammadex
Female subjects who are pregnant
Morbidly obese subjects with a BMI > 45 kg/m2 or weight more than 150 kg
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 100
Group description: Sugammadex 2 mg/kg IV once at the end of surgery

Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow
Eligibility criteria:
Inclusion Criteria:

Age ≥ 70 years
Elective surgery Monday through Friday in the South Operating Rooms of Oregon Health and Science University (OHSU)
Planned general endotracheal anesthesia
Expected surgical duration ≥ 3 hours

Exclusion Criteria:

Prisoners
An inability to consent for surgery or anesthesia
Surgery for which neuromuscular blockade is contraindicated (e.g. neurosurgical, orthopedic, and head and neck surgery in which nerve monitoring will be employed)
A known neuromuscular disorder
Stage 4 chronic kidney disease or worse (estimated glomerular filtration rate < 30 ml/min)
Liver Disease
An allergies to Sugammadex, Rocuronium, Neostigmine, or Glycopyrrolate
Patients taking Toremifene
Intervention: Neostigmine
Trial phase: Phase 4
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 100
Group description: Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery

Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 70 years
Elective surgery Monday through Friday in the South Operating Rooms of Oregon Health and Science University (OHSU)
Planned general endotracheal anesthesia
Expected surgical duration ≥ 3 hours

Exclusion Criteria:

Prisoners
An inability to consent for surgery or anesthesia
Surgery for which neuromuscular blockade is contraindicated (e.g. neurosurgical, orthopedic, and head and neck surgery in which nerve monitoring will be employed)
A known neuromuscular disorder
Stage 4 chronic kidney disease or worse (estimated glomerular filtration rate < 30 ml/min)
Liver Disease
An allergies to Sugammadex, Rocuronium, Neostigmine, or Glycopyrrolate
Patients taking Toremifene
Intervention: Dapivirine
Trial phase: Phase 3
ATC code: G01AX17
SMILES: Cc1cc(C)c(Nc2ccnc(Nc3ccc(C#N)cc3)n2)c(C)c1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 941
Group description: Dapivirine Vaginal Ring, 25 mg.Each participant will engage in the screening process for up to 45 days prior to enrolment and will use the monthly Dapivirine Vaginal Ring for a period of up to at least 12 months.

Dapivirine Vaginal Ring-004: To assess the safety profile of the 25 mg Dapivirine Vaginal Ring-004, when inserted at monthly intervals, in an open-label trial
Eligibility criteria:
Inclusion Criteria:

Women must meet all the following criteria to be eligible to enrol in the trial:

Previously enrolled in the IPM 027 trial
Available for all visits and consent to follow all procedures scheduled for the trial
Using an effective method of contraception at the Enrolment Visit, and intending to use an effective contraceptive method for the duration of trial participation, unless post-menopausal with no history of menses for one year prior to screening
HIV-negative as determined by the HIV algorithm applied at Screening/Pre- Enrolment
Willing to refrain from participation in another research trial using drugs, vaccines, medical devices and microbicides for the duration of the IPM 032 trial
Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures (e.g., by home visit or telephone; or via family or close neighbour contacts); confidentiality to be maintained.

Exclusion Criteria:

Women who meet any of the following criteria are NOT eligible to enrol in the trial:

Investigational product use permanently discontinued in response to an AE (where the AE was considered related to investigational product) or safety-related concern while taking part in the IPM 027 trial
Participant self-report of taking post-exposure prophylaxis (PEP) within ≤ 2 months at Screening Visit Note: Participants may be enrolled after completing the PEP regimen and a negative HIV test was documented at least 2 months prior to screening for IPM 032
Currently pregnant, intends to become pregnant or currently breast-feeding
Known drug abuse or alcohol dependence in the 12 months prior to screening
Participated in another research trial (other than IPM 027) using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 30 days prior to screening
Any new illness or condition(s), chronic condition(s) or abnormal laboratory finding(s) that, in the opinion of the investigator, might put the participant at risk, or interfere with the trial objectives or the participant's adherence to trial requirements
Intervention: Perhexiline
Trial phase: Phase 2
ATC code: C08EX02
SMILES: C1CCC(C(CC2CCCCN2)C2CCCCC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: All enrolled subjects
Eligibility criteria:
Key Inclusion Criteria:

Hypertrophic cardiomyopathy with symptoms of moderate-to-severe heart failure
Left ventricular hypertrophy with maximum LV wall thickness ≥ 15 mm
Left ventricular ejection fraction ≥ 50%
Able to perform exercise testing but unable to exceed 75% of the predicted age-adjusted maximum level

Key Exclusion Criteria:

CYP2D6 Poor Metabolizer (PM) status
History of a known chronic liver disease
ALT, AST, alkaline phosphatase, or LDH > 1.5 x upper limit of normal
Total Bilirubin > 2.0 x upper limit of normal
Severe LV outflow obstruction
Asymptomatic patients or cardiomyopathy-related criteria as per protocol
QT interval related criteria as per protocol