anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Epinephrine
Trial phase: Phase 4
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Epinephrine is the intracameral additive during cataract surgery.

Epinephrine: Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.
Eligibility criteria:
Inclusion Criteria:

Patients who are older than 18 years of age
Patients who are planned to undergo bilateral cataract surgery
Patients with baseline IOP of 5 - 22 mm Hg

Medicare insurance*

There is a significant cost difference between our two study drugs. Therefore, Medicare insurance is part of our inclusion criteria, because there is a pass-through reimbursement in place to cover the cost of phenylephrine/ketorolac. Other insurances (for example, Aetna Better Health, Highmark Freedom, Gateway) have variable or poor coverage for phenylephrine/ketorolac, which would leave the medical center responsible for the cost. Patients can never be held responsible for the cost of the medication because it is included in "covered services" for cataract surgery billing.

Exclusion Criteria:

Patients who are planned to undergo only unilateral cataract surgery
Patients who are planned to undergo cataract surgery and another surgical procedure in the same operation (eg. combined cataract and glaucoma surgery)
Patients with concurrent clinically significant disease, connective tissue disease, abnormal blood pressure at screening, narrow-angle or unstable glaucoma or treatment with prostaglandins, uncontrolled chronic eye disease or active corneal pathology or scarring
Patients with history of iritis or trauma with iris damage
Patients with recent eye surgery (non-laser surgery within 3 months or laser surgery within 30 days prior to study surgery)
Patients with clinically significant hypersensitivity to the study medications
Patients who have used pilocarpine (a pupil constrictor) within 6 months prior to surgery
Intervention: Phenylephrine and ketorolac injection
Trial phase: Phase 4
SMILES: CNCC(O)c1cccc(O)c1.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Omidria is the intracameral additive during cataract surgery.

Phenylephrine-ketorolac: Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery.
Eligibility criteria:
Inclusion Criteria:

Patients who are older than 18 years of age
Patients who are planned to undergo bilateral cataract surgery
Patients with baseline IOP of 5 - 22 mm Hg

Medicare insurance*

There is a significant cost difference between our two study drugs. Therefore, Medicare insurance is part of our inclusion criteria, because there is a pass-through reimbursement in place to cover the cost of phenylephrine/ketorolac. Other insurances (for example, Aetna Better Health, Highmark Freedom, Gateway) have variable or poor coverage for phenylephrine/ketorolac, which would leave the medical center responsible for the cost. Patients can never be held responsible for the cost of the medication because it is included in "covered services" for cataract surgery billing.

Exclusion Criteria:

Patients who are planned to undergo only unilateral cataract surgery
Patients who are planned to undergo cataract surgery and another surgical procedure in the same operation (eg. combined cataract and glaucoma surgery)
Patients with concurrent clinically significant disease, connective tissue disease, abnormal blood pressure at screening, narrow-angle or unstable glaucoma or treatment with prostaglandins, uncontrolled chronic eye disease or active corneal pathology or scarring
Patients with history of iritis or trauma with iris damage
Patients with recent eye surgery (non-laser surgery within 3 months or laser surgery within 30 days prior to study surgery)
Patients with clinically significant hypersensitivity to the study medications
Patients who have used pilocarpine (a pupil constrictor) within 6 months prior to surgery
Intervention: Buprenorphine
Trial phase: Phase 3
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 208
Group description: On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time.

For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator.
Eligibility criteria:
Inclusion Criteria:

Provide written consent to participate in this study.
Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014).
Be considered eligible in the medical judgment of the Investigator.

Females: Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent form (ICF)) must have a negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 6 months after the last dose of investigational medicinal product (IMP).

Males: Subjects with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the ICF through at least 6 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.

Subjects must agree not to take any buprenorphine products other than those administered during the current study throughout participation in the study.
Subjects must be willing to adhere to study procedures.

Exclusion Criteria:

Subject compliance issues during participation in the RB-US-13-0003 study which, in the opinion of the Investigator, could potentially compromise subject safety.
Women of childbearing potential who have a positive pregnancy test at RB-US-13-0003 at the end-of-study (EOS) visit, who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study.
History of suicidal ideation within 28 days prior to signing the ICF as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) "since last visit" assessment (completed in the EOS Visit for Study RB-US-13-0003), screening/baseline" assessment for the current study), or history of a suicide attempt (per the C-SSRS) in the 6 months prior to signing the ICF.
Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported additional buprenorphine, or over the counter (OTC) and/or herbal supplements with the potential to prolong QTc within 28 days of Day 1 unless prior written approval was obtained from the Medical Monitor.
Intervention: Ondansetron
Trial phase: Not Applicable
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: The entire cohort of patients in this open-label study
Eligibility criteria:
Inclusion Criteria:

Age between 18 and 70 years old;
Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
Ability to provide informed consent

Exclusion Criteria:

Not giving consent to participate in the study;
Patients with history of or current hepatic or renal insufficiency;
Patients with BMI ≥ 33;
Patients with heart failure or active arrhythmias;
Patients with severe systemic disease that is a constant threat to life;
Contraindication or allergy to ondansetron;
Pregnancy or lactation.
Prisoners
Intervention: Cannabidiol
Trial phase: Not Applicable
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 38
Group description: (300 mg, 600 mg, 900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
Eligibility criteria:
Inclusion Criteria:

18-35 years of age.
38 healthy volunteers (19 male, 19 female; age range 18-35 years)
All participants recruited without regard to race, religion or ethnicity through posters, advertisements and word-of-mouth referrals.
Candidates screened in accordance with our general screening protocol, approved by the IRB under Protocol #13681B, which includes a physical, EKG, psychiatric screening interview and detailed drug use history questionnaire.

Exclusion Criteria:

Individuals with a medical condition contraindicating study participation, as determined by the study site physician.
Individuals regularly using any medications aside from hormonal contraception in women.
Individuals with a current (active in the past year) DSM-IV Axis I mood, anxiety, eating, or substance dependence disorder or a lifetime history of a psychotic disorder or mania.
Women who are pregnant, nursing, or planning to become pregnant in the next 3 months
Participants reporting a known or suspected allergy to cannabinoids.
The self-report questionnaires the investigators use require fluency in English, and have not been translated and validated in other languages, thus individuals with less than a high-school education or those not fluent in English were excluded, as lack of English familiarity at a high school level may compromise our ability to interpret their self-reports.
Individuals with a BMI below 19 or above 30, as this would change dosing requirements.
Individuals who report using marijuana >100 times in their lifetime, to reduce variation in possible developed tolerance to CBD.
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Women receiving Ibuprofen for primary pain control following vaginal delivery.
Eligibility criteria:
Inclusion Criteria:

vaginal delivery
diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
preeclampsia without severe features
preeclampsia with severe features gestational hypertension without severe range blood pressures
gestational hypertension with severe range blood pressures
singleton pregnancies

Exclusion Criteria:

Cesarean Delivery
no diagnosis of hypertensive disorder
chronic or acute renal disease
allergy to ibuprofen or acetaminophen
lupus
multiple order pregnancies (twins, triplets)
Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs
Intervention: Ibuprofen
Trial phase: Not Applicable
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: All participants received all four study interventions. The first three interventions were administered in random order:

Oleocanthal-rich, D2i2
Oleacein-rich, D2i0.5
Oleocanthal and Oleacein-low, D2i0

All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit.
Eligibility criteria:
Inclusion Criteria:

Willing and able to comply with study protocols
Willing to drink 2 tablespoons of olive oil
BMI 18.5 to 30 kg/m2
Weight ≥ 110 pounds

Exclusion Criteria:

Adults who are not able to consent
BMI ≥ 31 kg/m2
Under current medical supervision
Self-reported daily use of drugs that are known to affect platelet function, such as aspirin, Excedrin, and NSAIDS
Ibuprofen intolerance or allergy
Cannot speak English
Allergy to olives or olive oil
Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individual following diets with significant deviations from the average diet of the general population.
A history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
Currently taking prescription drugs or supplements
Indications of substance or alcohol abuse within the last 3 years
Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements.
Not willing to refrain from olive oil consumption.
Blood Pressure ≥ 140/90 mmHg
Self-reported malabsorption
Metabolic panel results or complete blood counts that are outside of the normal reference range.
Screening LDL ≥ 190 mg/dl for those who have 0 - 1 major risk factors apart from LDL cholesterol [(i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [(i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
Screening LDL ≥ than 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol ((i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL), and a Framingham 10 - year Risk Score 10 - 20 % (using NCEP calculator).
Current enrollee in a clinical research study.
Individuals with blood clotting or platelet defect disorders
Intervention: Methionine
Trial phase: Phase 3
ATC code: V03AB26
SMILES: CSCCC(N)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 157
Group description: D-methionine liquid suspension also contains sorbitol, orange flavor and purified water Intervention: Drug: D-methionine, oral liquid suspension.

D-methionine: D-methionine, oral liquid suspension
Eligibility criteria:
Inclusion criteria:

Male or female 21 to 45 years of age Negative pregnancy test at enrollment and prior to taking study drug Willing to use an effective method of birth control during the study (Both male and female participants should avoid pregnancy during study) Pure tone air conduction threshold average at 0.5, 1 and 2 kHz of no greater than 40 dB HL bilaterally with no air bone gaps greater than 10 dB and normal otoscopy and tympanometry screens Willing to refrain from using supplements containing or derived from protein while participating in this study Ability to comply with all study requirements

Exclusion criteria:

History of allergic or idiosyncratic reaction to methionine, amino acid mixtures, nutritional supplements, egg white, or other proteins or food additives Vegetarian (Individual excludes meat and fish from their diet) History of chronic balance disorders Abnormal otoscopic findings, otologic surgery, autoimmune inner ear disease, significant air-bone gaps, abnormal tympanograms or other indication of middle-ear abnormality, history of fluctuant hearing or asymmetric hearing worse than 25 dB at any frequency in either ear, perilymphatic fistula, tumor of the auditory system, or other CNS disorder that is likely to affect hearing Treatment with intravenous (IV) antibiotics within the past 6 months Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug Treatment for alcohol or substance abuse within past 6 months Women of childbearing age who are not using effective contraceptive methods and who may become pregnant during the course of the study Women who are pregnant or breastfeeding. National Guardsmen History of psychotic schizophrenia Exposure within the previous 6 months to systemic ototoxic substances including aminoglycosides or vancomycin Body weight exceeding 225 pounds Renal impairment measured as eGFR < 50 on screening creatinine clearance blood draw.
Intervention: Midazolam
Trial phase: Phase 4
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.

Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Eligibility criteria:
Inclusion Criteria:

All patients admitted to the Duke CICU, who require intubation and sedation for mechanical ventilation that is expected to be >24 hours in duration will be included, unless they meet the specified exclusion criteria.
Patients intubated within one hour prior to care transition to the CICU will also be screened for inclusion.

Exclusion Criteria:

Exclusion criteria include patients following resuscitation from cardiac arrest who are treated on the cooling protocol
patients who have suffered a neurologic event (seizure, stroke) or who have baseline dementia, both of which could limit delirium assessment
patients with child class B and C liver disease
patients with known allergy to study medications.
Intervention: Diazepam
Trial phase: Phase 2 | Phase 3
ATC code: N05BA01
SMILES: CN1C(=O)CN=C(c2ccccc2)c2cc(Cl)ccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 3
Group description: Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.

Diazepam
Eligibility criteria:
Inclusion Criteria:

ESES and clinical CSWS/LKS defined by all of the following:
SWI ≥50% during first hour of sleep
Bilateral synchrony of discharges during sleep
Clinical evidence of behavior and/or academic regression
Daytime SWI ≤20%

Exclusion Criteria:

Previous treatment with benzodiazepine or acetazolamide for Electrical Status Epilepticus in Sleep (ESES)
Current treatment with carbamazepine, phenytoin, oxcarbazepine, phenobarbital, vigabatrin or lamotrigine
Antiepileptic medication changes over the month prior to enrollment
Epileptic encephalopathy other than CSWS/LKS
Prior serious adverse reaction to benzodiazepines or acetazolamide
Sulfa allergy
Progressive underlying neurologic condition
Frequent seizures that would prevent the patient from maintaining a stable dose of medications
Female patient that has begun menses or is pregnant
Intervention: Acetazolamide
Trial phase: Phase 2 | Phase 3
ATC code: G01AE10 | S01EC01
SMILES: CC(=O)Nc1nnc(S(N)(=O)=O)s1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 3
Group description: Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks.

Acetazolamide
Eligibility criteria:
Inclusion Criteria:

ESES and clinical CSWS/LKS defined by all of the following:
SWI ≥50% during first hour of sleep
Bilateral synchrony of discharges during sleep
Clinical evidence of behavior and/or academic regression
Daytime SWI ≤20%

Exclusion Criteria:

Previous treatment with benzodiazepine or acetazolamide for Electrical Status Epilepticus in Sleep (ESES)
Current treatment with carbamazepine, phenytoin, oxcarbazepine, phenobarbital, vigabatrin or lamotrigine
Antiepileptic medication changes over the month prior to enrollment
Epileptic encephalopathy other than CSWS/LKS
Prior serious adverse reaction to benzodiazepines or acetazolamide
Sulfa allergy
Progressive underlying neurologic condition
Frequent seizures that would prevent the patient from maintaining a stable dose of medications
Female patient that has begun menses or is pregnant
Intervention: Fenebrutinib
Trial phase: Phase 2
SMILES: C[C@H]1CN(C2COC2)CCN1c1ccc(Nc2cc(-c3ccnc(N4CCn5c(cc6c5CC(C)(C)C6)C4=O)c3CO)cn(C)c2=O)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Eligibility criteria:
Inclusion Criteria:

Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
If on oral corticosteroids (OCS), the dose must be </= 40 mg/day prednisone (or equivalent)
Stable doses of anti-malarial or immunosuppressive therapies
Participants must be willing to avoid pregnancy

Exclusion Criteria:

Proteinuria > 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample
Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
History of having required hemodialysis or high dose corticosteroids (>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
Neuropsychiatric or central nervous system lupus manifestations
Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
History of receiving a solid organ transplant
Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation
History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
Evidence of chronic and/or active hepatitis B or C