anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Roxadustat
Trial phase: Phase 2
ATC code: B03XA05
SMILES: Cc1nc(C(=O)NCC(=O)O)c(O)c2ccc(Oc3ccccc3)cc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
Eligibility criteria:
Inclusion Criteria:

18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader.
Chronic Kidney Disease Stage 3 or 4 with hemoglobin <11.0 grams (g)/deciliter (dL).
Normal iron studies.
Normal folate and vitamin B12 levels.
Liver function tests within normal limits at screening.
Absence of active or chronic rectal bleeding.
Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema, or diabetic proliferative retinopathy that is likely to require treatment during the trial.
Female participants must not be pregnant nor breastfeeding and agree to use acceptable method of contraception.
Male participants with partners who can have children must agree to use a medically acceptable method of contraception.

Exclusion Criteria:

Seropositive for HIV.
History of chronic liver disease.
History of polycystic kidney disease (PKD).
Uncontrolled hypertension (diastolic BP >110 millimeter of mercury (mmHg) or systolic BP >170 mmHg at screening).
New York Heart Association Class III or IV congestive heart failure.
Recent myocardial infarction or acute coronary syndrome.
History of myelodysplastic syndrome.
Any history of malignancy or a known genetic predisposition for developing cancer (for example, with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.
Active inflammatory infection or chronic inflammatory disease.
Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
Blood clots within 4 weeks.
History of ongoing hemolysis or diagnosis of hemolytic syndrome.
Known history of bone marrow fibrosis.
History of hemosiderosis or hemochromatosis.
Androgen therapy within 12 weeks.
Red blood cell transfusion within 12 weeks.
Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
Intravenous iron supplementation within the past 60 days.
Currently taking dapsone or acetaminophen >2.6 g/day.
History of prior organ transplantation.
Alcohol consumption greater than 3 or more drinks per day within the past year.
Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
Positive urine toxicology screen for a substance that has not been prescribed for the participant.
Intervention: Roxadustat
Trial phase: Phase 2
ATC code: B03XA05
SMILES: Cc1nc(C(=O)NCC(=O)O)c(O)c2ccc(Oc3ccccc3)cc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.
Eligibility criteria:
Inclusion Criteria:

18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader.
Chronic Kidney Disease Stage 3 or 4 with hemoglobin <11.0 grams (g)/deciliter (dL).
Normal iron studies.
Normal folate and vitamin B12 levels.
Liver function tests within normal limits at screening.
Absence of active or chronic rectal bleeding.
Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema, or diabetic proliferative retinopathy that is likely to require treatment during the trial.
Female participants must not be pregnant nor breastfeeding and agree to use acceptable method of contraception.
Male participants with partners who can have children must agree to use a medically acceptable method of contraception.

Exclusion Criteria:

Seropositive for HIV.
History of chronic liver disease.
History of polycystic kidney disease (PKD).
Uncontrolled hypertension (diastolic BP >110 millimeter of mercury (mmHg) or systolic BP >170 mmHg at screening).
New York Heart Association Class III or IV congestive heart failure.
Recent myocardial infarction or acute coronary syndrome.
History of myelodysplastic syndrome.
Any history of malignancy or a known genetic predisposition for developing cancer (for example, with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.
Active inflammatory infection or chronic inflammatory disease.
Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
Blood clots within 4 weeks.
History of ongoing hemolysis or diagnosis of hemolytic syndrome.
Known history of bone marrow fibrosis.
History of hemosiderosis or hemochromatosis.
Androgen therapy within 12 weeks.
Red blood cell transfusion within 12 weeks.
Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
Intravenous iron supplementation within the past 60 days.
Currently taking dapsone or acetaminophen >2.6 g/day.
History of prior organ transplantation.
Alcohol consumption greater than 3 or more drinks per day within the past year.
Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
Positive urine toxicology screen for a substance that has not been prescribed for the participant.
Intervention: Roxadustat
Trial phase: Phase 2
ATC code: B03XA05
SMILES: Cc1nc(C(=O)NCC(=O)O)c(O)c2ccc(Oc3ccccc3)cc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
Eligibility criteria:
Inclusion Criteria:

18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader.
Chronic Kidney Disease Stage 3 or 4 with hemoglobin <11.0 grams (g)/deciliter (dL).
Normal iron studies.
Normal folate and vitamin B12 levels.
Liver function tests within normal limits at screening.
Absence of active or chronic rectal bleeding.
Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema, or diabetic proliferative retinopathy that is likely to require treatment during the trial.
Female participants must not be pregnant nor breastfeeding and agree to use acceptable method of contraception.
Male participants with partners who can have children must agree to use a medically acceptable method of contraception.

Exclusion Criteria:

Seropositive for HIV.
History of chronic liver disease.
History of polycystic kidney disease (PKD).
Uncontrolled hypertension (diastolic BP >110 millimeter of mercury (mmHg) or systolic BP >170 mmHg at screening).
New York Heart Association Class III or IV congestive heart failure.
Recent myocardial infarction or acute coronary syndrome.
History of myelodysplastic syndrome.
Any history of malignancy or a known genetic predisposition for developing cancer (for example, with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.
Active inflammatory infection or chronic inflammatory disease.
Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
Blood clots within 4 weeks.
History of ongoing hemolysis or diagnosis of hemolytic syndrome.
Known history of bone marrow fibrosis.
History of hemosiderosis or hemochromatosis.
Androgen therapy within 12 weeks.
Red blood cell transfusion within 12 weeks.
Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
Intravenous iron supplementation within the past 60 days.
Currently taking dapsone or acetaminophen >2.6 g/day.
History of prior organ transplantation.
Alcohol consumption greater than 3 or more drinks per day within the past year.
Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
Positive urine toxicology screen for a substance that has not been prescribed for the participant.
Intervention: Roxadustat
Trial phase: Phase 2
ATC code: B03XA05
SMILES: Cc1nc(C(=O)NCC(=O)O)c(O)c2ccc(Oc3ccccc3)cc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
Eligibility criteria:
Inclusion Criteria:

18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader.
Chronic Kidney Disease Stage 3 or 4 with hemoglobin <11.0 grams (g)/deciliter (dL).
Normal iron studies.
Normal folate and vitamin B12 levels.
Liver function tests within normal limits at screening.
Absence of active or chronic rectal bleeding.
Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema, or diabetic proliferative retinopathy that is likely to require treatment during the trial.
Female participants must not be pregnant nor breastfeeding and agree to use acceptable method of contraception.
Male participants with partners who can have children must agree to use a medically acceptable method of contraception.

Exclusion Criteria:

Seropositive for HIV.
History of chronic liver disease.
History of polycystic kidney disease (PKD).
Uncontrolled hypertension (diastolic BP >110 millimeter of mercury (mmHg) or systolic BP >170 mmHg at screening).
New York Heart Association Class III or IV congestive heart failure.
Recent myocardial infarction or acute coronary syndrome.
History of myelodysplastic syndrome.
Any history of malignancy or a known genetic predisposition for developing cancer (for example, with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.
Active inflammatory infection or chronic inflammatory disease.
Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
Blood clots within 4 weeks.
History of ongoing hemolysis or diagnosis of hemolytic syndrome.
Known history of bone marrow fibrosis.
History of hemosiderosis or hemochromatosis.
Androgen therapy within 12 weeks.
Red blood cell transfusion within 12 weeks.
Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
Intravenous iron supplementation within the past 60 days.
Currently taking dapsone or acetaminophen >2.6 g/day.
History of prior organ transplantation.
Alcohol consumption greater than 3 or more drinks per day within the past year.
Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
Positive urine toxicology screen for a substance that has not been prescribed for the participant.
Intervention: Vytorin
Trial phase: Phase 4
ATC code: C10BA02
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21.O=C1C(CCC(O)c2ccc(F)cc2)C(c2ccc(O)cc2)N1c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Vytorin 10/80 divided into 4
Eligibility criteria:
Inclusion Criteria:

Subjects with an LDL-cholesterol greater than 100 mg/dL
Patients willing and able to provide signed informed consent

Exclusion Criteria:

Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
Patients intolerant of statins
Patients receiving ezetimibe
Patients intolerant of ezetimibe
Patients receiving a niacin preparation
Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
Cancer undergoing active treatment
Creatinine clearance < 50 ml/minute
Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
Participation in any clinical study within the last 30 days
Drug addition or alcohol abuse within the past 6 months
Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
Active use of macrolide antibiotics or verapamil
Consumption of grapefruit juice on a daily basis
Patients unwilling or unable to provide informed consent
Patients with poor compliance
Women of childbearing potential
Intervention: Simvastatin
Trial phase: Phase 4
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Simvastatin 20 milligrams
Eligibility criteria:
Inclusion Criteria:

Subjects with an LDL-cholesterol greater than 100 mg/dL
Patients willing and able to provide signed informed consent

Exclusion Criteria:

Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
Patients intolerant of statins
Patients receiving ezetimibe
Patients intolerant of ezetimibe
Patients receiving a niacin preparation
Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
Cancer undergoing active treatment
Creatinine clearance < 50 ml/minute
Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
Participation in any clinical study within the last 30 days
Drug addition or alcohol abuse within the past 6 months
Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
Active use of macrolide antibiotics or verapamil
Consumption of grapefruit juice on a daily basis
Patients unwilling or unable to provide informed consent
Patients with poor compliance
Women of childbearing potential
Intervention: Ezetimibe
Trial phase: Not Applicable
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: A whole ezetimibe 10 mg tablet
Eligibility criteria:
Inclusion Criteria:

Subjects receiving ezetimibe 10 mg

Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):

90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months
60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months
30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months
Patients willing and able to provide signed informed consent

Exclusion Criteria:

Patients not receiving ezetimibe
Patients receiving ezetimibe 5 milligrams
Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
Cancer undergoing active treatment
Participation in any clinical study within the last 30 days
Drug addiction or alcohol abuse within the past 6 months
Patients unwilling or unable to provide informed consent
Patients with poor compliance
Women of childbearing potential
Intervention: Ezetimibe
Trial phase: Not Applicable
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Ezetimibe 5 mg,
Eligibility criteria:
Inclusion Criteria:

Subjects receiving ezetimibe 10 mg

Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):

90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months
60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months
30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months
Patients willing and able to provide signed informed consent

Exclusion Criteria:

Patients not receiving ezetimibe
Patients receiving ezetimibe 5 milligrams
Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
Cancer undergoing active treatment
Participation in any clinical study within the last 30 days
Drug addiction or alcohol abuse within the past 6 months
Patients unwilling or unable to provide informed consent
Patients with poor compliance
Women of childbearing potential
Intervention: Ademetionine
Trial phase: Not Applicable
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.
Eligibility criteria:
Inclusion Criteria:

bipolar disorder
depressed for 3-12 months
mood unresponsive to at least 2 treatments
currently on mood stabilizer at therapeutic doses

Exclusion Criteria:

history of mania while on adequate mood stabilizer
rapid cycling bipolar disorder
previous use of SAMe during current episode
unstable medical illness including parkinson's disease
methotrexate use
pregnancy
substance abuse/dependence
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 226
Group description: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
Eligibility criteria:
Inclusion Criteria:

The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.
Past or planned surgery affecting gastric acid secretion.
Clinically significant hepatic or renal disorder.
Intervention: Gefarnate
Trial phase: Phase 3
ATC code: A02BX07 | A02BX77
SMILES: [H]/C(CC/C(C)=C(\[H])CCC(=O)OC/C([H])=C(\C)CCC=C(C)C)=C(/C)CCC=C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 234
Group description: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Eligibility criteria:
Inclusion Criteria:

The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.
Past or planned surgery affecting gastric acid secretion.
Clinically significant hepatic or renal disorder.
Intervention: Tamsulosin
Trial phase: Not Applicable
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
Eligibility criteria:
Inclusion Criteria:

18 y.o. or older
diagnosed with a kidney stone less than or equal to 10 mm determined by CT scan
physician has made the decision that you will be discharged to home
must be able to take study medication for up to 10 days and strain your urine
must be able to keep a record of pain medication taken and complete a pain scale rating

Exclusion Criteria:

patients currently taking: Tamsulosin (Flowmax), calcium channel blockers, beta blockers, alpha blockers, Sildenaphil (Viagara), Tadalaphil (Cilias), Warfarin (Coumadin, Jantoven), Cimetidine (Tagamet, Tagamet HB)
patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever
patient known to have hypersensitivity to Tamsulosin
patient history of cataract surgery
inability of patient to perform visual pain scale
allergy or intolerance to acetaminophen/oxycodone
patient is unable to understand informed consent
prisoners
Intervention: Pilocarpine
Trial phase: Phase 4
ATC code: N07AX01 | S01EB01 | S01EB51
SMILES: CC[C@@H]1C(=O)OC[C@@H]1Cc1cncn1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Pilocarpine 1% Ophthalmic Solution
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years
Chronic Angle Closure Glaucoma (CACG)
21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM
Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit
Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation
Peripheral anterior synechiae (PAS)

Exclusion Criteria:

Traumatic damage of the anterior chamber angle
History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months
Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks
Visual Acuity ≥ 1.0
Contact lenses wearer