anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cetirizine
Trial phase: Phase 2 | Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
Eligibility criteria:
Inclusion Criteria:

Positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to the study enrollment or during the study.
Intervention: Cetirizine
Trial phase: Phase 2 | Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
Eligibility criteria:
Inclusion Criteria:

Positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to the study enrollment or during the study.
Intervention: Cetirizine
Trial phase: Phase 2 | Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
Eligibility criteria:
Inclusion Criteria:

Positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to the study enrollment or during the study.
Intervention: Ibuprofen
Trial phase: Phase 3
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 82
Group description: Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
Eligibility criteria:
Inclusion Criteria:

1. Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.

Exclusion Criteria:

Have inadequate intravenous access
Patients with significant cognitive impairment
Active, clinically significant asthma
History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl.
Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding
Any child with obstructive sleep apnea, defined as an Apnea-Hypopnea Index of greater than or equal to 5.0
Have taken investigational drugs within 30 days before clinical trial material administration.
Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions. Surrogates will be needed for most patients.
Refusal to provide written authorization for use and disclosure of protected health information.
Be otherwise unsuitable for the study, in the opinion of the Investigator.
Intervention: Risperidone
Trial phase: Phase 4
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 30
Group description: Atypical antipsychotic

Risperidone: Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002).
Eligibility criteria:
Inclusion Criteria

Aged 6 to 17 years and weight of at least 15 kg
Meet DSM-IV criteria for of AD, established by chart review, clinical judgment and the Autism Diagnostic Interview- Revised (ADI-R) criteria
Clinical Global Impressions Severity (CGI-S) score of >4 (moderately ill)
ABC Irritability subscale score of >18
Mental age of at least 18 months
If female and sexually active, must agree to an acceptable method of birth control during the trial
Medication free or adequate washout period (2-4 weeks prior to enrollment) of psychoactive drugs (anticonvulsants permitted for seizure management if dosage is stable for 4 weeks)
Parent/guardian able to read and provide informed consent.

Exclusion Criteria

Psychiatric disorder that is effectively managed by psychoactive medication (e.g. ADHD, MDD)
Prior diagnosis or evidence of genetic or other disorder that may interfere with assessments (e.g. Fragile X syndrome, Fetal alcohol syndrome, history of very low birth weight) assessed by personal and family history, dysmorphology, and clinical judgment.
Prior use of risperidone or aripiprazole for more than 2 weeks
Seizure during the past 6 months
History or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments during the trial including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, hematologic or immunologic disease as determined by the clinical judgment of the investigator
Current suicidal or homicidal risk
Positive urine pregnancy test at baseline
Dependent on other substances, with the exception of nicotine or caffeine
Intervention: Aripiprazole
Trial phase: Phase 4
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 31
Group description: Atypical antipsychotic

Aripiprazole: The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks.
Eligibility criteria:
Inclusion Criteria

Aged 6 to 17 years and weight of at least 15 kg
Meet DSM-IV criteria for of AD, established by chart review, clinical judgment and the Autism Diagnostic Interview- Revised (ADI-R) criteria
Clinical Global Impressions Severity (CGI-S) score of >4 (moderately ill)
ABC Irritability subscale score of >18
Mental age of at least 18 months
If female and sexually active, must agree to an acceptable method of birth control during the trial
Medication free or adequate washout period (2-4 weeks prior to enrollment) of psychoactive drugs (anticonvulsants permitted for seizure management if dosage is stable for 4 weeks)
Parent/guardian able to read and provide informed consent.

Exclusion Criteria

Psychiatric disorder that is effectively managed by psychoactive medication (e.g. ADHD, MDD)
Prior diagnosis or evidence of genetic or other disorder that may interfere with assessments (e.g. Fragile X syndrome, Fetal alcohol syndrome, history of very low birth weight) assessed by personal and family history, dysmorphology, and clinical judgment.
Prior use of risperidone or aripiprazole for more than 2 weeks
Seizure during the past 6 months
History or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments during the trial including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, hematologic or immunologic disease as determined by the clinical judgment of the investigator
Current suicidal or homicidal risk
Positive urine pregnancy test at baseline
Dependent on other substances, with the exception of nicotine or caffeine
Intervention: Mifepristone
Trial phase: Phase 1 | Phase 2
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: 1 week mifepristone or placebo (followed by 3 weeks open label mifepristone)

Mifepristone: 300mg per day, by mouth, for 21-28 days
Eligibility criteria:
Inclusion Criteria:

Age 65 and older
Non-demented by clinical evaluation
Current or partially remitted generalized anxiety disorder or panic disorder
Currently taking antidepressant treatment with stable dose for at least 8 weeks
Memory impairment

Exclusion Criteria:

Mild to severe dementia
Diabetes
Current alcohol or substance abuse
Current or lifetime psychotic symptoms, bipolar disorder, or eating disorder
Untreated endocrinologic disease
Lifetime Cushing's or Addison's disease
Current cancer
History of metastatic cancer
Current use of systemic corticosteroids
Intervention: Bivalirudin
Trial phase: Phase 4
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Subjects will received prandial insulin based on the amount of carbohydrates consumed.

aspart: Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate)
Eligibility criteria:
Inclusion Criteria:

Adults aged > or = to 18 admitted to general surgical floors, excluding the ICU, at Rush University Medical Center, regardless of race, ethnicity, gender
Clinical diagnoses of type 2 diabetes for more than 6 months prior to admission
Treated with insulin and/or 2 or more oral diabetic agents
Estimated length of stay 3 days or more
Postoperative point of care blood glucose of > 180 mg/dL

Exclusion Criteria:

Glomerular Filtration Rate < 60 based on MDRD equation
Pregnant patients
Receiving parenteral or enteral nutrition
Patients with an admitting diagnosis of hypoglycemia
Outpatient insulin < 0.5 units/kg/day
Inability to give consent
Severe liver disease
Known hypopituitarism or adrenal insufficiency
Treatment with Prednisone at dose > 5 mg daily or its equivalent
Intervention: Pregabalin
Trial phase: Phase 1 | Phase 2
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Eligibility criteria:
Inclusion Criteria:

Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
Age 18 to 80 years old
Planned use of regional anesthesia
Ability to follow study protocol
English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

Patients younger than 18 years old and older than 80
Patients intending to receive general anesthesia
Allergy or intolerance to one of the study medications
Patients with an ASA of IV
Patients with hepatic (liver) failure
Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance < 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr < 30 mL/min, CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)])
Patients with difficult to manage diabetes mellitus, including insulin-dependence
Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
Chronic opioid use (taking opioids for longer than 3 months)
Patients with major prior ipsilateral open knee surgery.
Chronic neurontin/lyrica use
Intervention: Pregabalin
Trial phase: Phase 1 | Phase 2
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Eligibility criteria:
Inclusion Criteria:

Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
Age 18 to 80 years old
Planned use of regional anesthesia
Ability to follow study protocol
English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

Patients younger than 18 years old and older than 80
Patients intending to receive general anesthesia
Allergy or intolerance to one of the study medications
Patients with an ASA of IV
Patients with hepatic (liver) failure
Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance < 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr < 30 mL/min, CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)])
Patients with difficult to manage diabetes mellitus, including insulin-dependence
Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
Chronic opioid use (taking opioids for longer than 3 months)
Patients with major prior ipsilateral open knee surgery.
Chronic neurontin/lyrica use
Intervention: Pregabalin
Trial phase: Phase 1 | Phase 2
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Eligibility criteria:
Inclusion Criteria:

Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
Age 18 to 80 years old
Planned use of regional anesthesia
Ability to follow study protocol
English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

Patients younger than 18 years old and older than 80
Patients intending to receive general anesthesia
Allergy or intolerance to one of the study medications
Patients with an ASA of IV
Patients with hepatic (liver) failure
Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance < 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr < 30 mL/min, CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)])
Patients with difficult to manage diabetes mellitus, including insulin-dependence
Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
Chronic opioid use (taking opioids for longer than 3 months)
Patients with major prior ipsilateral open knee surgery.
Chronic neurontin/lyrica use
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: intranasal administration

Saline: 40 IUs
Eligibility criteria:
Inclusion Criteria:

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Subjects must meet DSM-IV criteria for current marijuana dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must identify marijuana as their primary substance of abuse and must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days.
Subjects must consent to remain abstinent from all drugs of abuse (except nicotine and marijuana) for a three-day period immediately prior to the CTRC admission. Subjects must abstain from marijuana for 24 hours prior to testing. By restricting marijuana use as proposed, subjects should not be under the acute effects of marijuana, and also may be experiencing mild withdrawal symptoms, the measurement of which is one of the outcome variables being tested.
Subjects must consent to random assignment.

Exclusion Criteria:

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses.
Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status.
Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response.
Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with hormonal measurements within one month of test session.
Subjects taking any psychotropic medications, including SRI's or other antidepressants, opiates or opiate antagonists because these may affect test response.
Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
Subjects who are obese (³ 20% over ideal weight) as this may interfere with hormonal status.
Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for three days prior to the stress task procedure.
Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or marijuana) within the past 60 days.
Intervention: Aminophylline
Trial phase: Phase 4
ATC code: R03DA05 | R03DA20 | R03DA55 | R03DB05
SMILES: Cn1c(=O)c2[nH]cnc2n(C)c1=O.Cn1c(=O)c2[nH]cnc2n(C)c1=O.NCCN
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: 75 mg of intravenous aminophylline.
Eligibility criteria:
Inclusion Criteria:

Adult patients referred to undergo a clinically-indicated regadenoson-stress myocardial perfusion imaging at Rush University Medical Center
Stage IV or V chronic kidney disease (GFR < 30, hemodialysis, and/or peritoneal dialysis).

Exclusion Criteria:

Patient refusal to participate
Known allergic reaction to aminophylline.
Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea, abdominal discomfort, nausea or vomiting.
Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and acute coronary symptoms.
Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12 months or any seizure in the past week.
Pregnant or breast-feeding women.
Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).
Intervention: Duotrav
Trial phase: Phase 4
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CC(C)OC(=O)CCCC=CCC1C(O)CC(O)C1C=CC(O)COc1cccc(C(F)(F)F)c1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
On a stable medication regimen for IOP reduction one week prior to the screening visit;
Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
Sign informed consent;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
Infection in either eye;
Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
Risk for visual field or visual acuity worsening, in the opinion of the investigator;
Women of childbearing potential;
Pregnant or lactating women;
Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
Participation in another clinical study within 30 days before the screening visit;
Other protocol-defined exclusion criteria may apply.
Intervention: Sitagliptin
Trial phase: Phase 2
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Exclusion Criteria:

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.