anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ecopipam
Trial phase: Phase 2
SMILES: [H][C@@]12c3cc(O)c(Cl)cc3CCN(C)[C@@]1([H])CCc1ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
Eligibility criteria:
Inclusion Criteria:

Subject must be diagnosed with Pathological Gambling according to DSMIV criteria
Subject must have at least 2 episodes of gambling behavior within the previous 2 weeks before screening
Subject must have gambling urges of at least moderate intensity

Exclusion Criteria:

Subjects must not have unstable medical illness or clinically significant abnormalities on lab tests, ECG, or physical exam
Subjects with major depressive episode within the last 2 years
Subjects with a history of attempted suicide
Subjects with first degree relative with major depressive episode that resulted in hospitalization, attempted or completed suicide
Subjects with a history of epilepsy or seizures
Subjects with a myocardial infarction (heart attack) with in the last 6 months
Subjects with a lifetime history of bipolar disorder, dementia, schizophrenia, or any psychotic disorder
Subjects with current of recent DSM-IV diagnosis of substance abuse or dependence (with the exception of nicotine)
Intervention: Solifenacin Succinate
Trial phase: Not Applicable
SMILES: O=C(O)CCC(=O)O.O=C(OC1CN2CCC1CC2)N1CCc2ccccc2C1c1ccccc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Vesicare™ (Solifenacin) : 5 mg daily
Eligibility criteria:
Inclusion Criteria:

Patients that have been diagnosed with prostate cancer and will undergo treatment for the disease as part of standard clinical care
Patients that have multiple pad use a few days after standard of care catheter removal

Exclusion Criteria:

Contra-indication to Solifenacin
Narrow angle glaucoma
Hepatic impairment
Renal impairment
CYP3A4 inhibitors (e.g. Ketoconazole)
Gastric Retention (delayed or slow emptying of the stomach)
Lives in a different country
Intervention: Timolol
Trial phase: Phase 1
ATC code: C07AA06 | C07BA06 | C07DA06 | S01ED01 | S01ED51
SMILES: [H][C@](O)(CNC(C)(C)C)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: timolol ophthalmic solution 0.5%
Eligibility criteria:
Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma in each eye
Requires IOP-lowering therapy in both eyes
Visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

Experienced significant weight change (over 10 pounds) within 60 days
History of alcohol or drug addiction
History of migraines or frequent headaches
Anticipated wearing of contact lenses during the study
Required chronic use of ocular medications during study
Eye surgery within 6 months
Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
Use of oral, intramuscular, intravenous corticosteroids within 21 days
Use of ophthalmic corticosteroids within 2 months
Intervention: Amphetamine
Trial phase: Phase 2
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
Eligibility criteria:
Inclusion Criteria:

21-65 years old
not currently enrolled in a treatment program
history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
self-reported Methamphetamine use on at least 15 of the past 30 days
use of at least one half gram of methamphetamine per week during the month prior to study entry
women of childbearing age must have a negative pregnancy test to enroll in this study

Exclusion Criteria:

current diagnosis of alcohol, opiate, or sedative physical dependence
ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
history of schizophrenia, or bipolar type I disorder
present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with d-amphetamine
medical contraindication to receiving study medications (e.g., previous adverse reaction to d-amphetamine)
chronic pain condition (due to impact on neurophysiological responses
current suicidality or psychosis
liver function tests (i.e., liver enzymes) greater than three times normal levels
pregnancy or breastfeeding
children 18-20 will be excluded because the P50 potential is not fully developed in children and adolescents
Intervention: Daptomycin
Trial phase: Phase 3
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Daptomycin intravenous 8mg/kg once per day 5-10 days.

Daptomycin : 8 mg/kg once daily

Daptomycin : 8 MG/KG IV
Eligibility criteria:
Inclusion Criteria:

Patients in the above categories who are currently undergoing chemotherapy.
Patients at least 18 of age.
Patient expected to reach an absolute granulocyte count of <100 cells/mm3
Patients who have given written consent because of the above criteria must have at least one temperature of greater or equal to 38.3° or temperatures > 38o on at least two occasions before study drug is administered.

Exclusion Criteria:

Patients with lymphoma or with solid tumor undergoing initial chemotherapy. Their neutropenia is of insufficient duration for adequate test of the value of an anti-gram positive antibiotic.
Patients undergoing auto-transplantation, for the same reason as above.
Patients with evidence of a clinical infection such as presence of a pulmonary infiltrate by x-ray or clinical evidence for the presence of cellulitis.
Patients who have received daptomycin in the two weeks prior to enrollment.
Patients with concomitant use of vancomycin.
Patients with creatinine clearance < 30 ml/min or CPK > 3x normal
Patients with significant hepatic dysfunction, defined as baseline liver function tests > 5x above normal.
Patients with known allergy to daptomycin.
Patients previously in this study.
Women of child bearing age who are either lactating or pregnant (as evidenced by a positive urine pregnancy test or positive serum beta-HCG).
Patients previously enrolled in this study.
Intervention: Lansoprazole
Trial phase: Phase 1
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 38
Group description: Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Is postmenopausal female in general good health with a body mass index of ≥18 and ≤30 kg/m2.
Must have biochemical markers of bone formation, procollagen type 1 N-terminal propeptide and bone-specific alkaline phosphatase, and bone resorption, crosslinked β-C-terminal telopeptide of type 1 collagen and urine N-telopeptide within normal postmenopausal female ranges.
Has not taken proton pump inhibitor medications within 6 months prior to screening and agrees to refrain from taking them through the last dose of study drug, except study-supplied dexlansoprazole or esomeprazole.

Exclusion Criteria:

Has parathyroid hormone or thyroid stimulating hormone levels outside of the reference range at Week -12 and has 25-OH-D level <32 ng/mL at Week -2.
Has baseline bone mineral density by dual-energy x-ray absorptiometry defined as a T-score lower than -2.0 at the total hip, spine, or femoral neck based on Caucasian reference values.
Has a disorder strongly associated with osteoporosis
Has a history of lumbar laminectomy, vertebroplasty, vertebral deformity or severe lumbar scoliosis that interferes with measurement or performance of the dual x-ray absorptiometry .
Has a history or clinical manifestations of uncontrolled or significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorder as determined by the investigator which may affect the ability of the subject to participate or potentially confound the trial results.
Has family history of genetic bone disorders.
Intervention: Omeprazole
Trial phase: Phase 1
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Is postmenopausal female in general good health with a body mass index of ≥18 and ≤30 kg/m2.
Must have biochemical markers of bone formation, procollagen type 1 N-terminal propeptide and bone-specific alkaline phosphatase, and bone resorption, crosslinked β-C-terminal telopeptide of type 1 collagen and urine N-telopeptide within normal postmenopausal female ranges.
Has not taken proton pump inhibitor medications within 6 months prior to screening and agrees to refrain from taking them through the last dose of study drug, except study-supplied dexlansoprazole or esomeprazole.

Exclusion Criteria:

Has parathyroid hormone or thyroid stimulating hormone levels outside of the reference range at Week -12 and has 25-OH-D level <32 ng/mL at Week -2.
Has baseline bone mineral density by dual-energy x-ray absorptiometry defined as a T-score lower than -2.0 at the total hip, spine, or femoral neck based on Caucasian reference values.
Has a disorder strongly associated with osteoporosis
Has a history of lumbar laminectomy, vertebroplasty, vertebral deformity or severe lumbar scoliosis that interferes with measurement or performance of the dual x-ray absorptiometry .
Has a history or clinical manifestations of uncontrolled or significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorder as determined by the investigator which may affect the ability of the subject to participate or potentially confound the trial results.
Has family history of genetic bone disorders.
Intervention: Metoclopramide
Trial phase: Not Applicable
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 306
Group description: Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
Eligibility criteria:
Inclusion Criteria:

English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
Scheduled or unscheduled cesarean delivery under spinal anesthesia
Height: 5 feet-5 feet 11 in.

Exclusion Criteria:

Laboring women needing an emergency cesarean delivery

Subjects less than 18 years of age
Receipt of a drug with antiemetic properties in the 24 hours prior to cesarean section
Allergy to ondansetron, or metoclopramide
Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
Severe Cardiac disease in pregnancy with marked functional limitations
Diabetes type I
Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Morbid obesity (body mass index (BMI)>45)
Inclusion in another anesthetic study involving drug administration
Intervention: FLUTICASONE PROPIONATE
Trial phase: Not Applicable
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.

Fluticasone: 220 ug twice a day for 3 weeks

Placebo: Placebo for 3 weeks
Eligibility criteria:
Inclusion Criteria:

For both healthy non-smokers and healthy current smokers:

normal spirometry Healthy current smokers: history of >10 pack-year smoking

Exclusion Criteria:

Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. Cardiovascular disease and/or use of cardiovascular medications. Subjects with known beta-adrenergic agonist or nitroglycerin intolerance. A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis).

Acute respiratory infection within four weeks prior to the study. Use of any airway medication. FEV1 < 80% of predicted and FEV1/FVC < 0.7. A body mass index > 30.
Intervention: Omarigliptin
Trial phase: Phase 2
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 113
Group description: Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
Eligibility criteria:
Inclusion Criteria:

The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.

The participant:

Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age;
Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; for Japan: BMI >18 kg/m^2 and <43 kg/m^2;
Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control;
Is a male, or a female who is highly unlikely to conceive.

Exclusion Criteria:

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.

The participant:

Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
Is on a weight loss program or has started a weight loss medication within the prior 8 weeks;
Has required insulin therapy within 14 weeks prior to signing informed consent;
Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease;
Has congestive heart failure or has new or worsening signs or symptoms of coronary heart disease;
Had any of the following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder;
Has a history of malignancy or clinically important hematological disorder
Intervention: Omarigliptin
Trial phase: Phase 2
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 115
Group description: Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
Eligibility criteria:
Inclusion Criteria:

The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.

The participant:

Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age;
Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; for Japan: BMI >18 kg/m^2 and <43 kg/m^2;
Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control;
Is a male, or a female who is highly unlikely to conceive.

Exclusion Criteria:

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.

The participant:

Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
Is on a weight loss program or has started a weight loss medication within the prior 8 weeks;
Has required insulin therapy within 14 weeks prior to signing informed consent;
Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease;
Has congestive heart failure or has new or worsening signs or symptoms of coronary heart disease;
Had any of the following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder;
Has a history of malignancy or clinically important hematological disorder
Intervention: Omarigliptin
Trial phase: Phase 2
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
Eligibility criteria:
Inclusion Criteria:

The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.

The participant:

Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age;
Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; for Japan: BMI >18 kg/m^2 and <43 kg/m^2;
Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control;
Is a male, or a female who is highly unlikely to conceive.

Exclusion Criteria:

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.

The participant:

Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
Is on a weight loss program or has started a weight loss medication within the prior 8 weeks;
Has required insulin therapy within 14 weeks prior to signing informed consent;
Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease;
Has congestive heart failure or has new or worsening signs or symptoms of coronary heart disease;
Had any of the following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder;
Has a history of malignancy or clinically important hematological disorder
Intervention: Omarigliptin
Trial phase: Phase 2
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 115
Group description: Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
Eligibility criteria:
Inclusion Criteria:

The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.

The participant:

Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age;
Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; for Japan: BMI >18 kg/m^2 and <43 kg/m^2;
Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control;
Is a male, or a female who is highly unlikely to conceive.

Exclusion Criteria:

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.

The participant:

Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
Is on a weight loss program or has started a weight loss medication within the prior 8 weeks;
Has required insulin therapy within 14 weeks prior to signing informed consent;
Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease;
Has congestive heart failure or has new or worsening signs or symptoms of coronary heart disease;
Had any of the following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder;
Has a history of malignancy or clinically important hematological disorder
Intervention: Omarigliptin
Trial phase: Phase 2
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
Eligibility criteria:
Inclusion Criteria:

The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.

The participant:

Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age;
Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; for Japan: BMI >18 kg/m^2 and <43 kg/m^2;
Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control;
Is a male, or a female who is highly unlikely to conceive.

Exclusion Criteria:

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.

The participant:

Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
Is on a weight loss program or has started a weight loss medication within the prior 8 weeks;
Has required insulin therapy within 14 weeks prior to signing informed consent;
Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease;
Has congestive heart failure or has new or worsening signs or symptoms of coronary heart disease;
Had any of the following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder;
Has a history of malignancy or clinically important hematological disorder