anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sunitinib
Trial phase: Not Applicable
ATC code: L01EX01
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(/C=C2\C(=O)Nc3ccc(F)cc32)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.

transcranial magnetic stimulation: Undergo TMS

electromyography: Undergo EMG

survey administration: Ancillary studies

sunitinib malate: Given PO
Eligibility criteria:
Inclusion Criteria:

Histologically proven renal cell cancer with metastases; pathology from either primary or metastatic tumor; no histologic subtype restriction
Evidence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or evaluable disease
Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
Hemoglobin >= 9 gram/dL
Common Terminology Criteria for Adverse Events (CTCAE) fatigue levels pre-treatment < 2
Signed and dated informed consent

Exclusion Criteria:

Greater than 2 previous systemic treatments for RCC
Heart failure, New York Heart Association (NYHA) class 3 and 4
Unstable angina (defined as ongoing use of nitrates or cardiac ischemia in the prior 6 months)
Arrhythmia uncontrolled by medication
Hypertension (> 160/90 mmHg) not controlled with medical management
Brain metastases or previous cranial radiation, leptomeningeal cancer
Surgery within 2 weeks of study entrance
History of stroke, myasthenia gravis, multiple sclerosis, polyneuropathy
Pregnancy or breast feeding
Central-nervous system active medications, intake or withdrawal of which lowers seizure threshold (determination made in consultation with study's responsible treating physician)
Any history of epilepsy, convulsion or seizure
Medication-resistant epilepsy in a first-degree relative
Cochlear implants or internal pulse generators or cardiac pacemakers or intracardiac lines
Metallic implants in the vicinity of discharging coil in the head or cervical spine
Unexplained fainting spells/syncope or multiple concussions
History of severe head trauma (followed by loss of consciousness)
Implanted brain or spinal cord electrodes/stimulation
Medication infusion device
Frequent/severe headaches or severe migraines
Past or current medical history of diagnosed or undiagnosed tinnitus
Intervention: Meperidine
Trial phase: Not Applicable
ATC code: N02AB02 | N02AB52 | N02AB72 | N02AG03
SMILES: CCOC(=O)C1(c2ccccc2)CCN(C)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 273
Group description: Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg.

Meperidine
Eligibility criteria:
Inclusion Criteria are as follows:

Over the age of 18
Undergoing non-urgent, non-emergent cesarean section at Mercy Hospital St. Louis

Exclusion Criteria:

non-English speaking
mentally disabled
allergy to meperidine
seizure disorder
renal impairment defined as a serum creatinine >0.8 mg/dL or patients who give a history of renal impairment
fever greater than 101
patients receiving low molecular weight heparin at any dose or unfractionated heparin at doses greater than 5000 u subcutaneous twice daily
pre-eclampsia requiring magnesium due to post-partum room assignment
obstructive sleep apnea due to post-partum room assignment
post-partum hemorrhage due to post-partum room assignment
Intervention: Meperidine
Trial phase: Not Applicable
ATC code: N02AB02 | N02AB52 | N02AB72 | N02AG03
SMILES: CCOC(=O)C1(c2ccccc2)CCN(C)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 273
Group description: Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg

Meperidine
Eligibility criteria:
Inclusion Criteria are as follows:

Over the age of 18
Undergoing non-urgent, non-emergent cesarean section at Mercy Hospital St. Louis

Exclusion Criteria:

non-English speaking
mentally disabled
allergy to meperidine
seizure disorder
renal impairment defined as a serum creatinine >0.8 mg/dL or patients who give a history of renal impairment
fever greater than 101
patients receiving low molecular weight heparin at any dose or unfractionated heparin at doses greater than 5000 u subcutaneous twice daily
pre-eclampsia requiring magnesium due to post-partum room assignment
obstructive sleep apnea due to post-partum room assignment
post-partum hemorrhage due to post-partum room assignment
Intervention: Clopidogrel
Trial phase: Phase 4
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5276
Group description: Subjects will receive clopidogrel once daily after the index PCI and will be retrospectively genotyped for CYP2C19*2, *3 and *17 alleles after completion of one year of treatment with clopidogrel.

Clopidogrel: One 75 mg tablet per day by mouth for one year
Eligibility criteria:
Inclusion

Patient >18 years of age
Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (CAD)
Patient is eligible for PCI
Patient is willing and able to provide informed written consent

5.3 Exclusion

Patient not able to receive 12 months of dual anti-platelet therapy
Failure of index PCI
Patient or physician refusal to enroll in the study
Patient with known CYP2C19 genotype prior to randomization
Planned revascularization of any vessel within 30 days post-index procedure and/or of the target vessel(s) within 12 months post-procedure
Anticipated discontinuation of clopidogrel or ticagrelor within the 12 month follow up period, example for elective surgery
Serum creatinine >2.5 mg/dL within 7 days of index procedure
Platelet count <80,000 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3 if persistent (at least 2 abnormal values) within 7 days prior to index procedure.
History of intracranial hemorrhage
Known hypersensitivity to clopidogrel or ticagrelor or any of its components
Patient is participating in an investigational drug or device clinical trial that has not reached its primary endpoint
Patient previously enrolled in this study
Patient is pregnant, lactating, or planning to become pregnant within 12 months
Patient has received an organ transplant or is on a waiting list for an organ transplant
Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the procedure
Patient is receiving immunosuppressive therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematous, etc.)
Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
Concomitant use of simvastatin/lovastatin > 40 mg qd
Concomitant use of potent CYP3A4 inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine)
Non-cardiac condition limiting life expectancy to less than one year, per physician judgment (e.g. cancer)
Known history of severe hepatic impairment
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
Inability to take aspirin at a dosage of 100 mg or less
Current substance abuse (e.g., alcohol, cocaine, heroin, etc.)
Intervention: Sotagliflozin
Trial phase: Phase 2
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
Eligibility criteria:
Inclusion Criteria:

Adults >=18 to <=55 years of age
Confirmed diagnosis of T1DM, diagnosed prior to age 40 years, and for at least 6 months prior to Screening
Willing to refrain from using carbohydrate counting to adjust insulin during the study
Willing and able to wear and operate a continuous glucose monitor
Willing and able to self-assess blood glucose
Willing and able to provide written informed consent.

Exclusion Criteria:

History of type 2 diabetes mellitus or diabetes resulting from acromegaly, Cushing's disease, chronic pancreatitis, or pancreatectomy
Two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to Screening
Use of premixed insulin
History of diabetic ketoacidosis within 1 year of screening
Presence of active hepatic disease or clinically significant abnormal liver function tests
History of chronic pancreatitis
Participants with a history of heart attack, severe/unstable angina, or coronary revascularization procedure
History of clinically significant cardiac arrhythmias within 1 year prior to screening
Participants with congestive heart failure
Participants with uncontrolled Stage III hypertension
History of human immunodeficiency virus (HIV) or hepatitis C
History of illicit drug or alcohol abuse within 12 months prior to Screening
Use of any investigational agent or device within 30 days prior to Screening or any therapeutic protein or antibody within 90 days prior to Screening
Use of medication or herbal supplements taken for weight loss within 2 weeks of screening
Chronic use of any antidiabetic therapy other than insulin within 2 months prior to Screening
Use of systemic or inhaled corticosteroids within 2 weeks prior to Screening
Participants who underwent major surgery within 6 months prior to Screening
Inability or difficulty swallowing whole tablets or capsules
Women who were pregnant or breastfeeding.
Intervention: Sotagliflozin
Trial phase: Phase 2
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
Eligibility criteria:
Inclusion Criteria:

Adults >=18 to <=55 years of age
Confirmed diagnosis of T1DM, diagnosed prior to age 40 years, and for at least 6 months prior to Screening
Willing to refrain from using carbohydrate counting to adjust insulin during the study
Willing and able to wear and operate a continuous glucose monitor
Willing and able to self-assess blood glucose
Willing and able to provide written informed consent.

Exclusion Criteria:

History of type 2 diabetes mellitus or diabetes resulting from acromegaly, Cushing's disease, chronic pancreatitis, or pancreatectomy
Two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to Screening
Use of premixed insulin
History of diabetic ketoacidosis within 1 year of screening
Presence of active hepatic disease or clinically significant abnormal liver function tests
History of chronic pancreatitis
Participants with a history of heart attack, severe/unstable angina, or coronary revascularization procedure
History of clinically significant cardiac arrhythmias within 1 year prior to screening
Participants with congestive heart failure
Participants with uncontrolled Stage III hypertension
History of human immunodeficiency virus (HIV) or hepatitis C
History of illicit drug or alcohol abuse within 12 months prior to Screening
Use of any investigational agent or device within 30 days prior to Screening or any therapeutic protein or antibody within 90 days prior to Screening
Use of medication or herbal supplements taken for weight loss within 2 weeks of screening
Chronic use of any antidiabetic therapy other than insulin within 2 months prior to Screening
Use of systemic or inhaled corticosteroids within 2 weeks prior to Screening
Participants who underwent major surgery within 6 months prior to Screening
Inability or difficulty swallowing whole tablets or capsules
Women who were pregnant or breastfeeding.
Intervention: Citalopram
Trial phase: Phase 2
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 23
Group description: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
Eligibility criteria:
Inclusion Criteria:

Men and women age 18-60;
Primary diagnosis of MDD. Diagnosis of MDD will be made with the Structured Clinical Interview for DSM-IV
Score of at least 23 on the Montgomery-Åsberg Depression Rating Scale
Treatment with citalopram at a dose no higher than 20mg/day for no longer than 4 weeks (subjects not currently taking an antidepressant will be started on citalopram 20mg/day for the 6-week open-label phase)
Ability to understand and sign the consent form.

Exclusion Criteria:

Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination (e.g., congestive heart failure, bradyarrhythmias).
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS)
Past 3-month DSM-IV substance abuse or dependence
Illegal substance use based on urine toxicology screening
Initiation of psychotherapy or behavior therapy specifically for MDD from a mental health professional within 3 months prior to study baseline
Initiation of any other psychotropic medication within 2 months prior to study inclusion
Concomitant use of any antidepressant (except low dose doxepin, amitriptyline, trazodone when used PRN as a hypnotic).
Concomitant use of medications that prolong the QT interval or are CYP2C19 inhibitors (e.g., cimetidine)
Previous treatment with vilazodone
Diagnosis of bipolar I or II disorder or any psychotic disorder (anxiety disorders will be allowed as long as MDD is considered the primary psychiatric disorder)
Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Intervention: Olopatadine
Trial phase: Phase 3
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 902
Group description: AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Eligibility criteria:
Inclusion Criteria:

Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
Presence of an ocular condition that may affect the study outcomes.
History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
History of anaphylactic reaction to any allergens used in this study.
Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.
Other protocol-defined exclusion criteria may apply.
Intervention: Olopatadine Hydrochloride
Trial phase: Phase 3
SMILES: CN(C)CCC=C1c2ccccc2COc2ccc(CC(=O)O)cc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 902
Group description: Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Eligibility criteria:
Inclusion Criteria:

Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
Presence of an ocular condition that may affect the study outcomes.
History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
History of anaphylactic reaction to any allergens used in this study.
Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.
Other protocol-defined exclusion criteria may apply.
Intervention: Olopatadine
Trial phase: Phase 3
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 902
Group description: Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Eligibility criteria:
Inclusion Criteria:

Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
Presence of an ocular condition that may affect the study outcomes.
History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
History of anaphylactic reaction to any allergens used in this study.
Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.
Other protocol-defined exclusion criteria may apply.
Intervention: Tofacitinib
Trial phase: Phase 1
ATC code: L04AA29
SMILES: C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Eligibility criteria:
Inclusion Criteria:

Healthy male and/or female subjects between ages of 18 and 55 years, inclusive.
Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

Use of tobacco- or nicotine-containing products in excess of equivalent of 5 cigarettes per day.
12-lead ECG demonstrating QTc >450 msec or other clinically significant abnormalities at Screening.
History of risk factors for QT prolongation or torsades de pointes.
Pregnant or nursing women; women of childbearing potential unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to first dose until completion of follow-up.
Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to first dose of trial medication.
Any clinically significant infections within past 3 months or evidence of infection in past 7 days.
Intervention: Donepezil
Trial phase: Phase 4
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: donepezil 5 mg every day

Donepezil: donepezil 5 mg once daily for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of diabetic neuropathy or failed back syndrome with neuropathic symptoms
Age 18-80
Taking a stable dose of gabapentin or pregabalin

Exclusion Criteria:

Pregnant women or women of child-bearing potential not willing to practice a reliable form of birth control
Allergy to donepezil or other piperidine derivatives (including fentanyl, alfentanil, sulfentanil, remifentanyl, demerol, tramadol, loperamide, diphenoxylate, betaprodine, alphaprodine, ethopropazine, anileridine, piminodine, 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine(MPTP),loratadine, fexofenadine
Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases that, in the opinion of the investigator, would preclude patients from finishing the trial
Any person with pending litigation
A history of major psychosis requiring hospitalization within the last three years
Non-English speaking, illiterate, unable to comprehend consent
Lack of contact information
Uncontrolled narrow-angle glaucoma
Currently being treatment with thioridazine (Mellaril)
Patients taking opioids will be excluded if they are taking a dosage that exceeds an equivalent of 30 mg of morphine per day
Patients taking more than one regular (not rescue) medication for pain
Patients taking donepezil for dementia
Patients with a baseline pain score less than 2 (0-10 scale) or greater than 8 (0-10) will be excluded