anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pravastatin
Trial phase: Phase 3
ATC code: C10AA03 | C10BA03 | C10BA11 | C10BA12 | C10BX02
SMILES: [H][C@@]12C(=C[C@@H](O)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 103
Group description: Pravastatin 10 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and postmenopausal females (aged 65 years and older
Eligible, able to participate, have given informed consent
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
Agree to be available

Exclusion Criteria

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus (HbA1c >8%).
Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
Liver injury
Impaired renal function
Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
Serum CK >5 x ULRR without clinical explanation
Uncontrolled hypothyroidism defined as TSH >ULRR
Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
Major surgery, 3 months prior to Visit 1
Significant CVD prior to randomization
Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of > 100 beats per minute at rest.
Left ventricular ejection fraction <0.25;
History of symptomatic cerebrovascular disease
Any other conditions at the discretion of the investigator
Known HIV infection
Poorly controlled or uncontrolled hypertension
Prior or current known muscular or neuromuscular disease of any type;
Neoplastic disease
Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
Current or recent use of supplements known to alter lipid metabolism
History of hypersensitivity to other HMG-CoA reductase inhibitors;
Concomitant medication not permitted
Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
Excessive obesity
Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 224
Group description: Pitavastatin 2 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and postmenopausal females (aged 65 years and older
Eligible, able to participate, have given informed consent
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
Agree to be available

Exclusion Criteria

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus (HbA1c >8%).
Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
Liver injury
Impaired renal function
Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
Serum CK >5 x ULRR without clinical explanation
Uncontrolled hypothyroidism defined as TSH >ULRR
Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
Major surgery, 3 months prior to Visit 1
Significant CVD prior to randomization
Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of > 100 beats per minute at rest.
Left ventricular ejection fraction <0.25;
History of symptomatic cerebrovascular disease
Any other conditions at the discretion of the investigator
Known HIV infection
Poorly controlled or uncontrolled hypertension
Prior or current known muscular or neuromuscular disease of any type;
Neoplastic disease
Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
Current or recent use of supplements known to alter lipid metabolism
History of hypersensitivity to other HMG-CoA reductase inhibitors;
Concomitant medication not permitted
Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
Excessive obesity
Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.
Intervention: Pravastatin
Trial phase: Phase 3
ATC code: C10AA03 | C10BA03 | C10BA11 | C10BA12 | C10BX02
SMILES: [H][C@@]12C(=C[C@@H](O)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Pravastatin 20 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and postmenopausal females (aged 65 years and older
Eligible, able to participate, have given informed consent
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
Agree to be available

Exclusion Criteria

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus (HbA1c >8%).
Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
Liver injury
Impaired renal function
Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
Serum CK >5 x ULRR without clinical explanation
Uncontrolled hypothyroidism defined as TSH >ULRR
Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
Major surgery, 3 months prior to Visit 1
Significant CVD prior to randomization
Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of > 100 beats per minute at rest.
Left ventricular ejection fraction <0.25;
History of symptomatic cerebrovascular disease
Any other conditions at the discretion of the investigator
Known HIV infection
Poorly controlled or uncontrolled hypertension
Prior or current known muscular or neuromuscular disease of any type;
Neoplastic disease
Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
Current or recent use of supplements known to alter lipid metabolism
History of hypersensitivity to other HMG-CoA reductase inhibitors;
Concomitant medication not permitted
Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
Excessive obesity
Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.
Intervention: Pitavastatin
Trial phase: Phase 3
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 210
Group description: Pitavastatin 4 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and postmenopausal females (aged 65 years and older
Eligible, able to participate, have given informed consent
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
Agree to be available

Exclusion Criteria

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus (HbA1c >8%).
Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
Liver injury
Impaired renal function
Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
Serum CK >5 x ULRR without clinical explanation
Uncontrolled hypothyroidism defined as TSH >ULRR
Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
Major surgery, 3 months prior to Visit 1
Significant CVD prior to randomization
Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of > 100 beats per minute at rest.
Left ventricular ejection fraction <0.25;
History of symptomatic cerebrovascular disease
Any other conditions at the discretion of the investigator
Known HIV infection
Poorly controlled or uncontrolled hypertension
Prior or current known muscular or neuromuscular disease of any type;
Neoplastic disease
Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
Current or recent use of supplements known to alter lipid metabolism
History of hypersensitivity to other HMG-CoA reductase inhibitors;
Concomitant medication not permitted
Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
Excessive obesity
Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.
Intervention: Pravastatin
Trial phase: Phase 3
ATC code: C10AA03 | C10BA03 | C10BA11 | C10BA12 | C10BX02
SMILES: [H][C@@]12C(=C[C@@H](O)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Pravastatin 40 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males and postmenopausal females (aged 65 years and older
Eligible, able to participate, have given informed consent
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
Agree to be available

Exclusion Criteria

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus (HbA1c >8%).
Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
Liver injury
Impaired renal function
Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
Serum CK >5 x ULRR without clinical explanation
Uncontrolled hypothyroidism defined as TSH >ULRR
Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
Major surgery, 3 months prior to Visit 1
Significant CVD prior to randomization
Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of > 100 beats per minute at rest.
Left ventricular ejection fraction <0.25;
History of symptomatic cerebrovascular disease
Any other conditions at the discretion of the investigator
Known HIV infection
Poorly controlled or uncontrolled hypertension
Prior or current known muscular or neuromuscular disease of any type;
Neoplastic disease
Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
Current or recent use of supplements known to alter lipid metabolism
History of hypersensitivity to other HMG-CoA reductase inhibitors;
Concomitant medication not permitted
Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
Excessive obesity
Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.
Intervention: Baclofen
Trial phase: Phase 2
ATC code: M03BX01
SMILES: NCC(CC(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
Eligibility criteria:
Inclusion Criteria:

Smoke at least 10 cigarettes per day for at least 6 months and considering quitting smoking in the next 6 months-

Exclusion Criteria:

Planning to attempt smoking cessation within the next 4 months
Weight less than 110 lbs. or above 220 lbs.
Use of tobacco products other than cigarettes in the previous month.
History of: Kidney disease, uncontrolled conditions (e.g., cardiac disease, pulmonary disease, diabetes, hypertension) Neurological disease (including stroke, mini-stroke, brain injury, Alzheimers Disease, encephalitis, meningitis, seizure disorder),Phenylketonuria Schizophrenia, Schizoaffective Disorder, Paranoid Disorder, or Schizotypal Disorder.
Current alcohol and/or drug use disorder as indicated by a screening questionnaire, past treatment for alcohol or substance use problems unless in remission(clean and sober for past year or more) or intention to seek treatment in the next 6 months for alcohol or substance use problems.
For women: Pregnancy, nursing, not using a reliable form of birth control.
Allergy to baclofen, Lioresal, or Kemstro.
Taking the following medications: antidepressants(excluding selective serotonin reuptake inhibitors), bupropion, phenothiazines, antihistamines, sedative/hypnotics, benzodiazepines, alpha blockers, beta blockers.
Lives with someone enrolled in the study.
Intervention: Salsalate
Trial phase: Phase 1 | Phase 2
ATC code: N02BA06
SMILES: O=C(Oc1ccccc1C(=O)O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Active Drug
Eligibility criteria:
Inclusion Criteria:

age 18 to 65 years, inclusive; HbA1c >6.0% (off medication-diabetic) normal hemoglobin and hematocrit, without donation of blood in the previous 2 months; without involvement in any study evaluating an investigational drug or device for the previous 2 months; normal clotting studies; female postmenopausal or surgically sterile, or using barrier or oral contraception and with a negative pregnancy test.

Exclusion Criteria:

pregnant or lactating women; patients with persistent ketonuria or a history of ketoacidosis (suggesting the need for insulin therapy); current of previous use of insulin for glucose control; patients with abnormal liver function defined as elevation of bilirubin, alkaline phosphatase, ALT, AST, or GGTP more than 1.5 times the upper limit of normal; patients with kidney disease (serum creatinine > 1.5 mg/dL) macroalbuminuria (1+ protein on a standard urine dip-stick, or > 300 mg urinary albumin/day)- (patients with microalbuminuria will be enrolled); patients with any significant diseases or conditions, including emotional or psychiatric disorders and substance abuse, including history of binge drinking, that, in the opinion of the investigator, are likely to alter the patient's ability to complete the study; patients with metabolic acidosis (abnormal anion gap); history of gastric ulcer, dyspepsia, or upper or lower GI bleed; history of allergy to aspirin, or bleeding diathesis or currently on oral anticoagulants including warfarin, heparin, aspirin or other NSAIDs; patients with major vascular event within 6 months of screening for the study (e.g., myocardial infarction stroke, coronary artery bypass graft (CABG) surgery, angioplasty, peripheral vascular surgery); patients with chronic heart disease, or a history of myocardial infarction or stroke. Symptomatic angina pectoris or cardiac insufficiency as defined by the NYHA; classification as Functional Class III or IV; patients with HbA1C > 13% (normal range 4-6%); patients who smoke more than one pack of cigarettes daily; patients taking treatment medications known to affect insulin sensitivity (e.g. diuretics, beta-blockers); patients taking warfarin, heparin or NSAID on a chronic basis; patients with inadequately controlled serum lipid levels (total cholesterol ≥ 275 mg/dL and fasting triglycerides ≥ 450 mg/dL); patients with history of cancer within 5 years prior to screening for the study other than basal cell carcinoma; active alcohol or other substance abuse.
Intervention: Cyclophosphamide
Trial phase: Phase 2
ATC code: L01AA01
SMILES: O=P1(N(CCCl)CCCl)NCCCO1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis of severe autoimmune enteropathy

Condition is resistant to conventional therapy
Histologic evidence of severe villous atrophy with intense lymphocytic infiltrate of the lamina propria by small intestinal biopsy within the past 3 months

Disease failed to respond after ≥ 2 months of corticosteroid therapy at a dose of ≥ 0.5 mg/kg/day or ≥ 40 mg/day for patients > 20 kg AND 1 of the following therapies:

Cyclosporine resulting in ≥ 1 whole blood level of > 200 ng/mL
Tacrolimus resulting in ≥ 1 whole blood level of 5 ng/mL
At least 50% estimated caloric needs provided by parenteral nutrition
History of intractable diarrhea, defined as frequent watery stools for > 3 months that does not respond to dietary restriction
No celiac disease, defined by a history of positive antiendomysial antibody or tissue transglutaminase antibody
No primary immunodeficiency or x-linked autoimmunity-allergy dysregulation

PATIENT CHARACTERISTICS:

Performance status

Lansky 60-100%

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Cardiovascular

Ejection fraction ≥ 40% OR shortening fraction ≥ 20%

Pulmonary

FVC or FEV_1 ≥ 50% of predicted (for patients > 8 years of age)
No clinically abnormal pulmonary function or abnormal pulse oximetry (for patients ≤ 8 years of age)

Other

Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 9 months after completion of study treatment
No known chromosomal abnormality

PRIOR CONCURRENT THERAPY:

Biologic therapy

No immunizations for at least 6 months after completion of study treatment

Endocrine therapy

See Disease Characteristics
At least 5 days since prior corticosteroids
No concurrent dexamethasone as an anti-emetic

Other

At least 5 days since other prior immunosuppressive medications (e.g., tacrolimus or cyclosporine)
Intervention: Cyclophosphamide
Trial phase: Phase 2
ATC code: L01AA01
SMILES: O=P1(N(CCCl)CCCl)NCCCO1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma, meeting 1 of the following criteria:

High-risk disease in first remission, as defined by the following:

Beta-2 microglobulin > 5.0 mg/dL
Chromosome 13 deletion
Primary refractory disease
Relapsed disease after achieving a response to prior chemotherapy

The following diagnoses are not allowed:

POEMS syndrome
Plasma cell leukemia
Amyloidosis
Nonsecretory myeloma
No evidence of spinal cord compression

PATIENT CHARACTERISTICS:

Age

Over 18

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use effective contraception
HIV negative
Has good organ function
Is in good physical condition
No active infection requiring antibiotics
No other malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

No persistently detectable donor cells after prior allogeneic stem cell transplantation
No prior rituximab

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

At least 28 days since prior therapy