anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sufentanil
Trial phase: Phase 3
ATC code: N01AH03
SMILES: CCC(=O)N(c1ccccc1)C1(COC)CCN(CCc2cccs2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 320
Group description: Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours
Eligibility criteria:
Inclusion Criteria:

Male or female patients who were 18 years of age or older.
Patients who were scheduled to undergo surgery under general or spinal anesthesia that does not include intrathecal opioids during the operation.
Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I).
Female patients of childbearing potential must have been using an effective method of birth control at the time of screening visit and for 30 days following the end of the study period. Acceptable methods of birth control included oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-child bearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for > 1 year, was specified. Patients using hormonal forms of contraception were also willing to use a barrier method of contraception from screening through 30 days following the study period.
Post-surgical patients who had been admitted to the PACU, and were expected to have acute pain requiring opioids for 24 - 72 hours after surgery.

Exclusion Criteria:

Patients who had taken an opioid for more than 30 consecutive days, at a daily dose of 15 mg or more of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
Patients who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken MAOIs within 14 days of the first dose of study drug.
Patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (CPAP).
Patients with an allergy or hypersensitivity to opioids.
Patients who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken MAOIs within 14 days of the first dose of study drug.
Patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (CPAP).
Patients who were receiving oxygen therapy at the time of screening.
Intervention: Intralipid
Trial phase: Phase 3
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: Child
Healthy volunteers: No
Participants at risk: 44
Group description: pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.

Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
Eligibility criteria:
Inclusion Criteria:

Inborn infants with a gestational age of less than 30 weeks
Who required parenteral nutrition for at least 7 days

Exclusion Criteria:

Evidence of congenital infection
Perinatal asphyxia
Congenital anomalies
Severe IVH
Thrombocytopenia
Shock or circulation failure
Renal or hepatic disorders.
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.

Tranexamic Acid
Eligibility criteria:
Inclusion Criteria:

Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture

Exclusion Criteria:

History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure
Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year
Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant
Patients with a known allergy to tranexamic acid
Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Sedation - monitored anesthesia with propofol.

Propofol: 1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.

1 of 2 sedation groups for VT ablation and afib procedures.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for cardiac electrophysiology procedures
Patients ≥18 years of age

Exclusion Criteria:

Gastroesophageal reflux disease (GERD),
pulmonary hypertension,
severe pulmonary disease,
obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)
Intervention: Sevoflurane
Trial phase: Phase 4
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: General anesthesia (GA) with Sevoflurane + O2

Sevoflurane: 1 general anesthesia group for VT ablations and afib procedures.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for cardiac electrophysiology procedures
Patients ≥18 years of age

Exclusion Criteria:

Gastroesophageal reflux disease (GERD),
pulmonary hypertension,
severe pulmonary disease,
obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve

Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally
Eligibility criteria:
Inclusion Criteria:

ED patient with acute migraine or probable migraine
Fail first line therapy with metoclopramide

Exclusion Criteria:

Can't obtain consent
Concern for secondary headache
Skull defect
Propensity for bleeding
Overlying infection
Pregnancy
Allergy, intolerance study medication
Intervention: ASPIRIN
Trial phase: Phase 4
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 246
Group description: Participants will be asked to take 81 milligrams by mouth once per day.

Aspirin: Aspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing radiofrequency catheter ablation for scar VT which includes VT secondary to ischemic cardiomyopathy and non-ischemic cardiomyopathy
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
Women must not be breastfeeding
WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with Apixaban plus 33 days post-treatment completion
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 93 days post-treatment completion
Participants must agree to the use of one approved method of contraception

Exclusion Criteria:

History of cerebral vascular accident/transient ischemic attack (CVA/TIA) in last 3 months
Cardiac surgery or neurosurgery within 3 months of the intended procedure date
Any active bleeding
Severe hypersensitivity reaction to ELIQUIS (including drug hypersensitivity, such as skin rash and allergic reactions)
Participants cannot have prosthetic heart valves
History or bleeding and clotting disorders
Contraindications to Aspirin therapy
Contraindication to oral anticoagulation
Patient on an anticoagulant prior to the ablation for other primary indications like atrial fibrillation (AF), deep vein thrombosis (DVT) or a mechanical valve
Evidence of intracardiac thrombus
Patient with Creatinine Clearance of < 30 cc/min
Participation in another investigational study related to oral anticoagulation, drug and/or device intervention
Claustrophobic patients
Implantable Cardioverter Defibrillator (ICD) generator placement before the year 2000
Has an ICD and is pacing dependent without underlying rhythm upon interrogation at baseline
Patient has abandoned leads
Patients who are on p-glycoprotein inducers or inhibitors where the dose of Apixaban cannot be effectively altered
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection
Eligibility criteria:
Inclusion Criteria:

Planned on- or off-pump cardiac surgery including: bypass grafting, valvular procedures, congenital defect correction, and thoracic aortic procedures or a combination of these procedures

Exclusion Criteria:

Emergency surgery
Pregnancy
Previous renal transplantation
Documented moderate to severe acute kidney injury prior to enrollment (e.g. RIFLE-I or RIFLE-F/KDIGO stage 2 or 3)
Patients already receiving dialysis (acute or chronic) or in imminent need of dialysis at time of enrollment
Chronic kidney disease without baseline serum creatinine value obtained within 6 months of enrollment
Intervention: Isolyte S
Trial phase: Phase 2
SMILES: CC(=O)[O-].CC(=O)[O-].CC(=O)[O-].OCC1OC(O)C(O)C(O)C1O.[Cl-].[K+].[Mg+2].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection
Eligibility criteria:
Inclusion Criteria:

Planned on- or off-pump cardiac surgery including: bypass grafting, valvular procedures, congenital defect correction, and thoracic aortic procedures or a combination of these procedures

Exclusion Criteria:

Emergency surgery
Pregnancy
Previous renal transplantation
Documented moderate to severe acute kidney injury prior to enrollment (e.g. RIFLE-I or RIFLE-F/KDIGO stage 2 or 3)
Patients already receiving dialysis (acute or chronic) or in imminent need of dialysis at time of enrollment
Chronic kidney disease without baseline serum creatinine value obtained within 6 months of enrollment
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: All participants receive open-label ketamine

Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes
Eligibility criteria:
Inclusion Criteria:

be 18-64 years old,
read, understand, and provide written informed consent in English,
meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) for ≥ 4 weeks,
have a history ≥1 failed medication trial during the current depression,
be on a stable adequate dose of an FDA-approved antidepressant medication for ≥28 days,
maintain a treating doctor who is in agreement with study participation,
have a reliable chaperone to accompany them home following the completion of the ketamine infusion day,
be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
be of non-childbearing potential or use of an acceptable form of birth control (females only).

Exclusion Criteria:

delirium or dementia diagnosis,
unstable medical illness or clinically significant laboratory results,
history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects (e.g., requirement of cardiac pacemaker) or alter brain morphology (e.g., recent head trauma, post intracranial surgery, intracranial mass or bleed or unstable sleep apnea), or a blood pressure >140/95 mmHg at Screening,
history of multiple adverse drug reactions,
current/past history of psychotic disorders, history of out-of-body feelings or derealization,
active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP (phencyclidine) abuse (we will confirm this with collateral information from their doctor if necessary),
requirement of excluded medications that may interact with ketamine,
caffeine or nicotine use within 1 hour of psychophysiology testing, or alcohol use within 1 day of testing,
pregnancy, breastfeeding, or unacceptable means of birth control (females only)
clinically significant hearing impairment,
current serious suicidal or homicidal risk,
concurrent participation in other research studies involving medications or other treatments,
narrow angle glaucoma,
acute intermittent porphyria history,
history of seizures in the past 6 months, regardless of seizure type,
hyperthyroidism or untreated hypothyroidism,
airway instability or pulmonary disease with hypercarbia, or
current or past cubital or carpal tunnel syndrome.
Intervention: Ramelteon
Trial phase: Phase 4
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Has difficulty in initiating sleep at least 3 days per week for at least 4 weeks at the time of informed consent.
Has Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)-defined depression.
Man or woman between 20 and 64 years of age, inclusive, at the time of informed consent.
Outpatient.
Meets either of the following criteria based on the 17-item Hamilton Rating Scale for Depression (HAM-D17) both at the start of the run-in period and the start of the study treatment period: has a score of 2 for "6: Insomnia Early", or has a score of 1 for "6: Insomnia Early" AND a score of at least 3 in total for "7: Insomnia Middle" and "8: Insomnia Late".
Has a total HAM-D17 score of 16 or under both at the start of the run-in period and the start of the study treatment period.
Under treatment of the same antidepressant agents on a stable dose for at least 4 weeks before the start of the run-in period.
Goes to bed routinely in a daily life (time for bed between 21.00 p.m. and 1.00 a.m. at least 4 days per week).
Actigraphy shows at least 3 days with sleep latency 30 minutes or longer AND total nocturnal sleep time 6.5 hours or shorter on the same day during the run-in period.
In the opinion of the principal investigator or investigator, is capable of understanding the contents of the study and complying with study requirements.
Is capable of signing and dating the informed consent form in person before any study procedures.

Exclusion Criteria:

Has a history of hypersensitivity to ramelteon and melatonin.
Has severe liver disorder.
Took ramelteon within 4 weeks before the informed consent.
Using any insomnia medications (including investigational drugs and unapproved drugs) for 2 weeks before the treatment period.
Shift worker or night worker.
Has complications of psychiatric or neurological diseases that affect sleep state other than depression.
Has a HAM-D17 score of at least 1 for"11: Suicide" at the start of the run-in period or the start of the study treatment period, or any suicide attempts within 24 weeks before or during the run-in period.
Pregnant woman, nursing mother, or woman who plans to become pregnant or donate eggs before the informed consent, during the study period or within 4 weeks after the end of the study.
Is participating in any other investigational or post-marketing clinical trial/study.
For other reason, judged not appropriate for participation in this study by the principal investigator or investigator.
Intervention: Intepirdine
Trial phase: Phase 2
SMILES: O=S(=O)(c1ccccc1)c1cnc2c(N3CCNCC3)cccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: RVT-101 35 mg once daily

RVT-101 35 mg: once daily, oral, 35-mg tablets
Eligibility criteria:
Inclusion Criteria:

Male or female subject with probable DLB
Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion Criteria:

Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.
Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.
Intervention: Intepirdine
Trial phase: Phase 2
SMILES: O=S(=O)(c1ccccc1)c1cnc2c(N3CCNCC3)cccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 88
Group description: RVT-101 70 mg once daily

RVT-101 70 mg: once daily, oral, 35-mg tablets
Eligibility criteria:
Inclusion Criteria:

Male or female subject with probable DLB
Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion Criteria:

Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.
Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.
Intervention: TESTOSTERONE UNDECANOATE
Trial phase: Phase 1 | Phase 2
SMILES: CCCCCCCCCCC(=O)O[C@H]1CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.

Oral Testosterone Undecanoate: Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
Eligibility criteria:
Inclusion Criteria:

Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of < 300 ng/dL.
Adequate venous access to allow blood sample collections via venous cannula.
Naïve to androgen-replacement therapy or willing to temporarily cease current T treatment and willing to remain off all forms of T except for study medication throughout study.
Voluntarily provide written informed consent to participate in this study.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria will not be eligible:

Significant intercurrent disease (especially liver, kidney, heart disease, uncontrolled diabetes mellitus or psychiatric illness)
Abnormal prostate digital rectal examination, elevated PSA (PSA > 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA.
BMI less than 18 kg/m2 or greater than 37 kg/m2
Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.
History of severe or multiple allergies, or severe adverse drug reaction. A known hypersensitivity to lidocaine or all surgical dressings which may be used in the study procedures.
History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.
Oral, topical or buccal T therapy within previous one week, or intramuscular T injection within previous 4 weeks.
Parenteral T-undecanoate therapy within the past 6 months.
Use of dietary supplements that may increase serum T, within previous 4 weeks.
Known malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, clofibrate, gemfibrozil, and probucol.
Smokers unable to refrain from smoking during required confinement period.
History of, or current evidence of, abuse of alcohol or any drug substance.
Receipt of any research study drug within 30 days of study.
Blood donation within the 12 week period before the initial study dose.
Hematocrit less than 35% or greater than 50%.
History of clinically significant polycythemia following treatment with a testosterone replacement product.
Current use of paroxetine, clomipramine, antiandrogens, estrogens, potent P450 enzyme inducers, or barbiturates.
History of uncontrolled sleep apnea.