anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Warfarin
Trial phase: Phase 2
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Intervention Drug warfarin no change in the dose is performed
Eligibility criteria:
Inclusion Criteria:

Patients on long-term warfarin (for prophylaxis of arterial embolism in patients with atrial fibrillation or mechanical heart valve replacement, or secondary prophylaxis after VTE) with a target INR of 2.0-3.0 or 2.5-3.5,
Anticoagulant therapy managed by the clinic (HHS - General Hospital) for at least 3 months prior to enrolment, and
Maintenance dose of warfarin unchanged for the previous 3 months or longer.
The INR result is outside the therapeutic range as follows:

For those with target 2.0-3.0: Either an INR of 1.5-1.9 or an INR of 3.1-4.4. For those with target 2.5-3.5: Either an INR of 1.5-2.4 or an INR of 3.6-4.4.

Exclusion Criteria:

Age <18 years,
Long-term (>1 week) change in any other medication
Long-term (>1 week) change in diet, especially regarding green vegetables.
Attending physician believes the patient is not suitable for the study (e.g. psychiatric disorder, history of non-compliance),
Failure to obtain telephone consent.
Intervention: Warfarin
Trial phase: Phase 2
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
Eligibility criteria:
Inclusion Criteria:

Patients on long-term warfarin (for prophylaxis of arterial embolism in patients with atrial fibrillation or mechanical heart valve replacement, or secondary prophylaxis after VTE) with a target INR of 2.0-3.0 or 2.5-3.5,
Anticoagulant therapy managed by the clinic (HHS - General Hospital) for at least 3 months prior to enrolment, and
Maintenance dose of warfarin unchanged for the previous 3 months or longer.
The INR result is outside the therapeutic range as follows:

For those with target 2.0-3.0: Either an INR of 1.5-1.9 or an INR of 3.1-4.4. For those with target 2.5-3.5: Either an INR of 1.5-2.4 or an INR of 3.6-4.4.

Exclusion Criteria:

Age <18 years,
Long-term (>1 week) change in any other medication
Long-term (>1 week) change in diet, especially regarding green vegetables.
Attending physician believes the patient is not suitable for the study (e.g. psychiatric disorder, history of non-compliance),
Failure to obtain telephone consent.
Intervention: Bosentan
Trial phase: Phase 2
ATC code: C02KX01 | G01AE10
SMILES: COc1ccccc1Oc1c(NS(=O)(=O)c2ccc(C(C)(C)C)cc2)nc(-c2ncccn2)nc1OCCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Bosentan 62.5mg orally, twice a day for four weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of asthma, maintained on a minimum of 1 anti-inflammatory/controller and daily long acting B-agonist therapy with inadequate control of symptoms. (Defined as symptoms including wheezing, chest tightness or shortness of breath occurring at least 3 times a week or requiring use of "rescue" short-acting B-agonist at least 3 times a week).
FEV1 less than 80% of predicted and greater than 40% at screening visit.
A minimum of 12% reversibility of FEV1 after albuterol on screening visit or previously documented during the prior two years.
Women of childbearing potential must use 2 non-hormonal methods of birth control (2 methods between the subject and her partner) while on the study and for 1 month after the last dose of study medication.
Male subjects must use two non hormonal methods of birth control (2 methods between the subject and his partner) while on the study and for 1 month after the last dose of study medication.

Exclusion Criteria:

History of liver disease, clinically significant cardiac disease, renal disease or pulmonary disease other than asthma. Patients with clinically significant laboratory abnormalities of LFTs/bilirubin (AST/ALT, TBili, alkaline phosphatase) and clinically significant anemia will be excluded. Clinically significant anemia will be defined as any anemia resulting in serum Hgb more than 1 gm/dl below the LLN, Patients with isolated minimal elevations of bilirubin (eg. as occurs in Gilbert's disease) or minimal elevations in transaminases (less than 1.2 x ULN) without a history of liver disease, risk factors for liver disease or symptoms of liver disease may still be included in the study at the investigator's discretion, but will have LFT testing at each study visit.)
Cigarette history of >10 pack years.
Predicted inability to adhere to medication regimen or documentation requirements of the study (symptom and medication diaries).
Respiratory infection during 30 days preceding screening visit.
Requirement for change in scheduled asthma medication use, including oral steroid dose change, or acute medical care for asthma during the 30 days preceding screening visit.
Predicted inability to safely refrain from B-agonist use for the required amount of time on study visit days.
Use of tiotropium
Pregnancy, breast feeding or the use of hormonal methods of birth control as the only means of birth control during the study.
Use of potent CYP3A4 and CYP2C9 inhibitors, including, but not limited to azole antifungals, amiodarone, glyburide, warfarin, cyclosporine, ritonavir, other medications potentially toxic to the liver or bone marrow.
Use of any illegal drugs or alcohol abuse.
Intervention: Rosuvastatin
Trial phase: Phase 4
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
Eligibility criteria:
Inclusion Criteria:

metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)
LDL-Cholesterol > 130mg/dl
HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females
Triglycerides < 400 mg/dl

Exclusion Criteria:

With a concomitant coronary disease
Currently under statin therapy or previously treated with statins within the last 6 months
Intervention: Promega
Trial phase: 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: 15
Group description: All subjects will receive Omegaven

Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.
Eligibility criteria:
Inclusion Criteria:

Two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition dependent infant or child (unable to meet nutritional needs solely by enteral nutrition)
Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
The patient must have utilized standard therapies to prevent the progression of the liver disease including reduction/removal of copper and manganese from daily PN, trial of enteral feeding if possible, and the use of ursodiol (i.e., Actigall®).

Exclusion Criteria:

Documented causes of chronic liver disease other than parenteral nutrition associated liver disease
Proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.
An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven®
Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
Unstable diabetes mellitus or hyperglycemia
Stroke, embolism, collapse and shock, recent MI
Cholestasis due to any reason other than parenteral associated liver disease
Active new infection at time of initiation of Omegaven®
Hemodynamic instability
The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).
Intervention: Estriol
Trial phase: Phase 3
ATC code: G03CA04 | G03CC06
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)[C@H](O)C[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women (no menses for the previous 12 months)
Dryness, itching or burning in and around the vagina
Discontinued hormone replacement therapy (either local or systemic) at least 3 months

Exclusion Criteria:

Known, suspected, or history of cancer of the breast.
Known, or suspected estrogen dependent neoplasia (ovarian, endometrial).
Known hypersensitivity to any component of the medications or base creams.
Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
Active or recent (within the past year) arterial thromboembolic disease (stroke, myocardial infarct).
Liver dysfunction or disease with elevation of aspartate aminotransferase (AST)>1.5x upper level of normal (ULN); Normal for females is 8-43 U/L.
Undiagnosed abnormal genital bleeding.
Known chronic lichen sclerosis.
Known, untreated vaginal infection.
Not had a normal screening mammogram within the last 15 months.
Hysterectomy without oophorectomy unless 60 years or older.
Women taking aromatase inhibitors or tamoxifen.
Hgb <12.0 or >15.5 g/dL
Urinalysis showing a urinary tract infection (UTI).
Intervention: ESTRADIOL VALERATE
Trial phase: Phase 3
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](OC(=O)CCCC)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women (no menses for the previous 12 months)
Dryness, itching or burning in and around the vagina
Discontinued hormone replacement therapy (either local or systemic) at least 3 months

Exclusion Criteria:

Known, suspected, or history of cancer of the breast.
Known, or suspected estrogen dependent neoplasia (ovarian, endometrial).
Known hypersensitivity to any component of the medications or base creams.
Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
Active or recent (within the past year) arterial thromboembolic disease (stroke, myocardial infarct).
Liver dysfunction or disease with elevation of aspartate aminotransferase (AST)>1.5x upper level of normal (ULN); Normal for females is 8-43 U/L.
Undiagnosed abnormal genital bleeding.
Known chronic lichen sclerosis.
Known, untreated vaginal infection.
Not had a normal screening mammogram within the last 15 months.
Hysterectomy without oophorectomy unless 60 years or older.
Women taking aromatase inhibitors or tamoxifen.
Hgb <12.0 or >15.5 g/dL
Urinalysis showing a urinary tract infection (UTI).
Intervention: Fenofibrate
Trial phase: Phase 2
ATC code: C10AB05 | C10BA03 | C10BA04 | C10BA09 | C10BA12
SMILES: CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Fenofibrate 145 mg
Eligibility criteria:
Inclusion Criteria:

Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway Pressure (CPAP) or presenting clinical symptoms of sleep apnea
Overweight or obese, with BMI >= 25 kg/m² and < 40 kg/m².
Known moderate hypertriglyceridemia, with fasting Triglycerides level >= 2.0 and < 6.0 mmol/L within 3 months before the inclusion.

Exclusion Criteria:

indication for immediate CPAP
other known endocrine disease, except treated and adequately controlled hypothyroidism
renal failure or plasma creatinine level >130 µmol/L
current chronic liver disease or ALanine Amino Transferase (ALT)> 2 times the upper normal limit (UNL)
symptomatic gallbladder disease
known muscular disease or creatine phosphokinase (CK) > 3 times UNL.
Intervention: Osilodrostat
Trial phase: Phase 2
ATC code: H02CA02
SMILES: N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of hypertension with blood pressure ≥ 140/90 millimeters of mercury (mmHg) and < 180/110 mmHg on current antihypertensive treatment
Male and female participants 18-75 years of age
Participants must weigh at least 50 kilograms (kg)

Exclusion Criteria:

Recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebral accident or transient ischemic attack
Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] > 9%)
Malignancies within the last 5 years (excluding basal cell skin cancer)
Liver disease

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Osilodrostat
Trial phase: Phase 2
ATC code: H02CA02
SMILES: N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of hypertension with blood pressure ≥ 140/90 millimeters of mercury (mmHg) and < 180/110 mmHg on current antihypertensive treatment
Male and female participants 18-75 years of age
Participants must weigh at least 50 kilograms (kg)

Exclusion Criteria:

Recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebral accident or transient ischemic attack
Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] > 9%)
Malignancies within the last 5 years (excluding basal cell skin cancer)
Liver disease

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: 20 mg dexamethasone IV push
Eligibility criteria:
Inclusion Criteria:

Subject has intraabdominal disease either proven or strongly suspected to be ovarian or primary peritoneal cancer, and will be undergoing surgical debulking.
Subject is not allergic to dexamethasone, and there is no obvious medical contraindication to dexamethasone.
Subjects with diabetes requiring drug therapy are excluded.
Subject is not currently receiving glucocorticoid therapy
Nasal steroids (e.g. Flonase) are permitted
Subject understands that this protocol does not have therapeutic intent
Preoperative serum albumin at least 3.0 mg/dL
Negative serum or urine pregnancy test in women of childbearing potential
Signed informed consent

Exclusion Criteria:

Males do not get ovarian cancer and therefore will not be included in this trial.
Patients of all ethnic backgrounds are eligible and will be encouraged to enroll. However we do not expect differences based on ethnicity, and this small study will not therefore be powered to make conclusions about ethnic differences in induction of GR-regulated genes with dexamethasone.
Intervention: Osilodrostat
Trial phase: Phase 2
ATC code: H02CA02
SMILES: N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
Eligibility criteria:
Inclusion criteria:

Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and <180 mmHg
Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension
Male and female participants 18 to 75 years of age

Exclusion criteria:

Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] >9%)
Malignancies within the last 5 years (excluding basal cell skin cancer)

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Osilodrostat
Trial phase: Phase 2
ATC code: H02CA02
SMILES: N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
Eligibility criteria:
Inclusion criteria:

Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and <180 mmHg
Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension
Male and female participants 18 to 75 years of age

Exclusion criteria:

Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] >9%)
Malignancies within the last 5 years (excluding basal cell skin cancer)

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Osilodrostat
Trial phase: Phase 2
ATC code: H02CA02
SMILES: N#Cc1ccc([C@H]2CCc3cncn32)c(F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
Eligibility criteria:
Inclusion criteria:

Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and <180 mmHg
Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension
Male and female participants 18 to 75 years of age

Exclusion criteria:

Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] >9%)
Malignancies within the last 5 years (excluding basal cell skin cancer)

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Eplerenone
Trial phase: Phase 2
ATC code: C03DA04
SMILES: [H][C@@]12CC[C@@]3(CCC(=O)O3)[C@@]1(C)C[C@H]1O[C@@]13[C@@]2([H])[C@H](C(=O)OC)CC1=CC(=O)CC[C@@]13C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
Eligibility criteria:
Inclusion criteria:

Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and <180 mmHg
Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension
Male and female participants 18 to 75 years of age

Exclusion criteria:

Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] >9%)
Malignancies within the last 5 years (excluding basal cell skin cancer)

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: 3-[5-(azetidine-1-carbonyl)pyrazin-2-yl]oxy-5-[(2S)-1-methoxypropan-2-yl]oxy-N-(5-methylpyrazin-2-yl)benzamide
Trial phase: Phase 2
SMILES: COCC(C)Oc1cc(Oc2cnc(C(=O)N3CCC3)cn2)cc(C(=O)Nc2cnc(C)cn2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: AZD1656
Eligibility criteria:
Inclusion Criteria:

Male or women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)
Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard)

Exclusion Criteria:

History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus