anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pioglitazone
Trial phase: Phase 2
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: 30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.
Eligibility criteria:
Inclusion Criteria:

Insulin resistance or mild diabetes mellitus
Symptoms of abdominal pain
Xray test showing damage to the pancreas
Normal or mildly abnormal stool fat levels

Exclusion Criteria:

Mentally disabled patients
Women who are planning pregnancy, pregnant or lactating/nursing

Chronic pancreatitis is due to other specific conditions

Autosomal dominant pancreatitis
Classic cystic fibrosis with lung involvement
Autoimmune pancreatitis
Pancreatic cancer
Biliary obstruction (non-pancreatic cause)
Abdominal trauma
Hypercalcemia
Hypertriglyceridemia
Surgical resection of the head of the pancreas
Alcohol consumption within prior 2 months

Specific medical conditions

Gastric surgery
Celiac sprue
Crohns disease
Heart failure
Kidney failure
Cirrhosis or liver disease
Osteoporosis
Blood clotting disorder
Visual problems
Low albumin
Low BMI
Specific medications *Diabetes drug treatment is allowed except for short-acting insulin, long-acting insule more than 15 units daily, pioglitazone, rosiglitazone, orlistat, acarbose, miglitol or voglibose.
Intervention: Paliperidone
Trial phase: Phase 4
ATC code: N05AX13
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 289
Group description: Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Eligibility criteria:
Inclusion Criteria:

Participants who are diagnosed with schizophrenia (diagnosis criteria: Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV])
Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening-Lack of efficacy, lack of tolerance or lack of compliance
Participants who are capable of and willing to fill out the questionnaire for themselves
Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
Participants who are compliant with self-medication or can receive consistent help or support

Exclusion Criteria:

Participants with the past history of neuroleptic malignant syndrome (NMS), or with allergy or hypersensitivity to risperidone or paliperidone
Participants who have taken clozapine within one month before screening
Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile)
Participants with a known or suspected history (for 6 months and longer) of substance dependence according to the DSM-IV criteria
Intervention: Zanamivir
Trial phase: Phase 3
ATC code: J05AH01
SMILES: [H][C@@]1([C@H](O)[C@H](O)CO)OC(C(=O)O)=C[C@H](N=C(N)N)[C@H]1NC(C)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
Eligibility criteria:
Inclusion Criteria:

18-69 years old as of 01/Nov/2008
have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
available for follow-up during the study period
if a women of child-bearing years, must meet criteria to prevent pregnancy

Exclusion Criteria:

allergy to any component of influenza vaccine or zanamivir
previous serious adverse event associated with influenza vaccination
receipt of influenza vaccine between 01/Mar/2008 and start of study
previous adverse event associated with the use of antiviral medications
expecting to be unable to take zanamivir for more than 72 hours during study period
planning to spend more than 2 consecutive weeks outside Canada or more than 100 km from the study site during study period
pregnant, or planning to become pregnant, during study period
breastfeeding, or planning to breastfeed, a child under 12 months of age during study period
receipt of immunoglobulin within six months of study entry
immunocompromising condition or therapy that would be expected to reduce the efficacy of vaccination
plans to receive cytotoxic or radiation therapy during study period
history of cardiovascular or pulmonary disease that has required hospital admission within the past year
history of asthma or other chronic respiratory disease
participating in a trial that will result in the receipt of an investigational medication during the period that zanamivir may be taken (15/Nov/2008 to 30/Apr/2009)
Intervention: Rosiglitazone
Trial phase: Phase 1
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age
Non-smoking
Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
Body mass index (BMI) less than or equal to 32
Medically healthy on the basis of medical history and physical examination
Hemoglobin > or = to 11.5g/dL
Completion of the screening process within 28 days prior to dosing
Provision of voluntary written informed consent

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or plasma donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Drug allergies to quinine sulfate or rosiglitazone
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits

Exclusion Criteria:

Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:

Six months or more (immediately prior to Screening Visit) without a menstrual period, or
Prior hysterectomy, or
Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
Documented endometriosis or active pelvic inflammatory disease (PID);
Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;

Use of prohibited concomitant medications:

Depo-Provera use must cease ten months prior to first dose of study drug, or
GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits

Exclusion Criteria:

Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:

Six months or more (immediately prior to Screening Visit) without a menstrual period, or
Prior hysterectomy, or
Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
Documented endometriosis or active pelvic inflammatory disease (PID);
Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;

Use of prohibited concomitant medications:

Depo-Provera use must cease ten months prior to first dose of study drug, or
GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Intervention: Midazolam
Trial phase: Phase 1
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Adverse effects on day 1 after participants received 2mg of midazolam syrup orally.
Eligibility criteria:
Inclusion Criteria:

Medically healthy non-smoking, non-obese (≥ 60 kg males, ≥52 kg females within 15% of IBW) adult volunteers 18-45 years of age

Exclusion Criteria:

Subjects with history or presence of significant cardiovascular disease (including hypotension, hypertension, bradycardia or EKG abnormalities), pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or an active sexually transmitted disease.
Subjects with significant blood loss in the prior 56 days, plasma donation within 7 days , hemoglobin < 12.0 g/dl or who have participated in another clinical trial within the prior 30 days.
Subjects with recent (2-year) history or evidence of alcoholism or drug abuse.
Subjects who have used any drugs or substances known to inhibit or induce cytochrome P450 (CYP) enzymes 10 days or 28 days respectively prior to the first dose and throughout the study.
Subjects who have received monoamine oxidase inhibitors or been on a special diet within 28 days of starting the study.
Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).

Subjects who are pregnant or lactating, taking hormone replacement therapy or have known allergies to quinine sulfate, mefloquine, quinidine or midazolam and other benzodiazepines.
Intervention: Nebivolol
Trial phase: Phase 4
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
Eligibility criteria:
Inclusion Criteria:

male and female outpatients 18 to 79 years of age
Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
meet criteria for stage I or II hypertension
currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion Criteria:

type 1 or type 2 diabetes
secondary hypertension
evidence of other concurrent disease or conditions that might interfere with the conduct of the study
treatment with any investigational study drug within 30 days of Screening (Visit 1)
have a history of hypersensitivity to nebivolol or other β-blockers
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 1
Group description: The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.
Eligibility criteria:
Inclusion Criteria:

Japanese epilepsy patients with renal impairment

Exclusion Criteria:

NA
Intervention: Paroxetine Mesylate
Trial phase: Phase 2
SMILES: CS(=O)(=O)O.Fc1ccc(C2CCNCC2COc2ccc3c(c2)OCO3)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
Eligibility criteria:
Inclusion Criteria:

Female, >40 years of age
Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior
Spontaneous amenorrhea for at least 12 consecutive months
Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy

Exclusion Criteria:

History of hypersensitivity or adverse reaction to paroxetine mesylate
Use of an investigational study medication within 30 days prior to screening or during the study
Concurrent participation in another clinical trial or previous participation in this trial
Family of investigational-site staff
Intervention: Rivaroxaban
Trial phase: Phase 2
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
Eligibility criteria:
Inclusion Criteria:

Confirmed acute symptomatic proximal deep- vein thrombosis and/or pulmonary embolism
Concomitant use of a strong CYP 3A4 inducer, (i.e., carbamazepine, phenytoin, rifampicin/rifampin, and rifabutin)

Exclusion Criteria:

Legal lower age limitations (country specific)
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of deep -vein thrombosis and/or pulmonary embolism
Other indication for vitamin K antagonist (VKA) than deep -vein thrombosis and/or pulmonary embolism
Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole)
Use of the strong CYP 3A4 inducers phenobarbital/primidone or St John's Wort
Intervention: Lovenox
Trial phase: Phase 3
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 934
Group description: Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
Eligibility criteria:
Inclusion Criteria:

Receiving warfarin therapy for at least 3 months, administered to achieve an international normalized ratio (INR) range of 2.0 to 3.0
Requiring temporary interruption of warfarin for pre-specified elective procedure or surgery

Presence of one of the following conditions:

Chronic (permanent or paroxysmal) nonvalvular atrial fibrillation, confirmed by at least one prior electrocardiography recording or pacemaker or acid citrate dextrose (ACD) interrogation
Chronic (permanent or paroxysmal) valvular atrial fibrillation with evidence of mitral valvular heart disease, confirmed by the same criteria as nonvalvular atrial fibrillation

Presence of at least one of the following major stroke risk factors:

Older than 75 years of age
Hypertension
Diabetes mellitus
Congestive heart failure or left ventricular dysfunction
Previous ischemic stroke, systemic embolism, or transient ischemic attack (TIA)

Exclusion Criteria:

Any mechanical prosthetic heart valve
Stroke (ischemic or hemorrhagic), systemic embolism, or TIA within the past 12 weeks
Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks
Major bleeding within the past 6 weeks
Severe renal insufficiency, measured through a calculated creatinine clearance of less than 30 mL/min
Thrombocytopenia
Life expectancy less than 1 month
Condition that impairs compliance with trial protocol, such as cognitive impairment, an uncontrolled psychiatric condition, or geographic inaccessibility
Pregnancy
Allergy to heparin or history of heparin-induced thrombocytopenia

Having one of the following surgeries or procedures during warfarin interruption:

Cardiac surgery, such as coronary artery bypass or heart valve replacement
Neurosurgery that is intracranial or intraspinal, such as tumor resection or aneurysm repair
High-risk non-surgical procedures, such as brain biopsy
Other surgical or non-surgical procedure that, at the discretion of the surgeon, precludes administration of therapeutic-dose low molecular weight heparin (LMWH) at any time in the post-procedure period
More than one surgery planned during the trial period
Prior participation in this trial
Intervention: Intralipid
Trial phase: Not Applicable
SMILES: CCCCCC=CCC=CCCCCCCCC(=O)O.CCCCCCCCC=CCCCCCCCC(=O)OC(COC(=O)CCCCCCCCCCCCCCC)COP(=O)(O)OCC[N+](C)(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: 20% lipid infusion in trained subjects

20% lipid infusion: 1.5 ml/min for 6 hours
Eligibility criteria:
Inclusion Criteria:

Regardless of training status, age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type 29 and we would like to limit the confounding effects of age.
We will define the lean group by a BMI of < 25 kg/m2. Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
The untrained subjects must not be engaged in a regular exercise program (< 30 minutes regular exercise over 1 week).
The trained subjects should be participating in regular running exercise (> 45 min/day, ≥ 5 days/week) and preferably be currently or recently participating in competitions (within 2 years).

Exclusion Criteria:

Regardless of training status, subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills or diuretics.
The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire. We will also administer a PAR-Q questionnaire (attached) to establish whether the subject will be safe for exercise testing. - The female subjects must not be pregnant. A pregnancy test will be performed prior to all study visits.
If screening TG are > 300 (based on 1st visit results) or fasting glucose > 100 (based on 1st visit results), the subjects will be excluded.
If the subject is allergic to eggs (used in lipid emulsions), soybeans(used in lipid emulsions), or lipid emulsions the subject will be excluded from the study.
Subjects taking anti-platelet agents (if anti-platelet agent cannot be held for seven days) and subjects taking anticoagulation therapy will be excluded.
Subjects with clinically significant medical issues or a history of hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5), pulmonary, or cardiac abnormalities (including abnormal EKG) will also be excluded.
Intervention: Intralipid
Trial phase: Not Applicable
SMILES: CCCCCC=CCC=CCCCCCCCC(=O)O.CCCCCCCCC=CCCCCCCCC(=O)OC(COC(=O)CCCCCCCCCCCCCCC)COP(=O)(O)OCC[N+](C)(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: lipid infusion into untrained subjects

20% lipid infusion: 1.5 ml/min for 6 hours
Eligibility criteria:
Inclusion Criteria:

Regardless of training status, age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type 29 and we would like to limit the confounding effects of age.
We will define the lean group by a BMI of < 25 kg/m2. Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
The untrained subjects must not be engaged in a regular exercise program (< 30 minutes regular exercise over 1 week).
The trained subjects should be participating in regular running exercise (> 45 min/day, ≥ 5 days/week) and preferably be currently or recently participating in competitions (within 2 years).

Exclusion Criteria:

Regardless of training status, subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills or diuretics.
The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire. We will also administer a PAR-Q questionnaire (attached) to establish whether the subject will be safe for exercise testing. - The female subjects must not be pregnant. A pregnancy test will be performed prior to all study visits.
If screening TG are > 300 (based on 1st visit results) or fasting glucose > 100 (based on 1st visit results), the subjects will be excluded.
If the subject is allergic to eggs (used in lipid emulsions), soybeans(used in lipid emulsions), or lipid emulsions the subject will be excluded from the study.
Subjects taking anti-platelet agents (if anti-platelet agent cannot be held for seven days) and subjects taking anticoagulation therapy will be excluded.
Subjects with clinically significant medical issues or a history of hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5), pulmonary, or cardiac abnormalities (including abnormal EKG) will also be excluded.