anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 14
Group description: 3600 NAC mg/day

N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
Eligibility criteria:
Inclusion Criteria:

Current frequency of at least one NSSI episode in the past 2 months
≥ 5 past episodes of NSSI with significant tissue damage (e.g. scars present)
Psychotropic medications are dose-stable for 1 month
Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

Any MRI contraindications (e.g. metal plates, claustrophobia, braces, implanted devices)
Any current serious medical illness as defined by medical history
Current Substance Use Disorder (except Tobacco Use Disorder)
Primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder)
Neurodevelopmental disorder such as mental retardation or autism
Changes in psychotropic medications in past 1 month
Taken NAC or glutathione on a regular basis in the past 6 months
Currently pregnant, planning to become pregnant, currently breastfeeding, or unwillingness to use contraception throughout the study.
Allergy/sensitivity to N-acetylcysteine.
Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 11
Group description: 5400 NAC mg/day

N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
Eligibility criteria:
Inclusion Criteria:

Current frequency of at least one NSSI episode in the past 2 months
≥ 5 past episodes of NSSI with significant tissue damage (e.g. scars present)
Psychotropic medications are dose-stable for 1 month
Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

Any MRI contraindications (e.g. metal plates, claustrophobia, braces, implanted devices)
Any current serious medical illness as defined by medical history
Current Substance Use Disorder (except Tobacco Use Disorder)
Primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder)
Neurodevelopmental disorder such as mental retardation or autism
Changes in psychotropic medications in past 1 month
Taken NAC or glutathione on a regular basis in the past 6 months
Currently pregnant, planning to become pregnant, currently breastfeeding, or unwillingness to use contraception throughout the study.
Allergy/sensitivity to N-acetylcysteine.
Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 61
Group description: EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)

Exparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35

Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
Adhesive tapes will be applied at the level of the TAP block puncture sites.
Eligibility criteria:
Inclusion Criteria:

Age 18-75 years
Elective laparoscopic colorectal surgery
ASA I-III

Exclusion Criteria:

Contraindication to Na Channel Blocker
Chronic Opioid use
Liver dysfunction
Renal insufficiency
Epilepsy
Psychomotor retardation
BMI >40
Sleep Apnea
Cardiac Rhythm Disorders
Planned open or concomitant procedure
Intervention: Elobixibat
Trial phase: Phase 2
ATC code: A06AX09
SMILES: CCCCC1(CCCC)CN(c2ccccc2)c2cc(SC)c(OCC(=O)N[C@@H](C(=O)NCC(=O)O)c3ccccc3)cc2S(=O)(=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Elobixibat 5 mg once daily

Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).
Eligibility criteria:
Key Inclusion Criteria:

Have a current biopsy-confirmed NASH within 6 months of screening or a suspected diagnosis of NAFLD/NASH
Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10% liver steatosis
Fasting serum low density lipoprotein-cholesterol (LDL-C) >130 mg/dL at Screening, >110 mg/dL on lipid-lowering medications

Key Exclusion Criteria:

Body mass index (BMI) <25 kg/m2
Fibrosis-4 index (Fib-4) >2.6

Any of the following laboratory abnormalities:

alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or aspartate aminotransferase (AST) >5 × ULN
International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy
Total bilirubin >ULN, except with an established diagnosis of Gilbert's syndrome
Platelet count less than the lower limit of normal (LLN)
Creatinine clearance as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation <60 mL/min
Uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) >9.5%
Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to thyroid dysfunction.
Uncontrolled hypertension
Participants with known intolerance to MRI or with conditions contraindicated for MRI procedures
Intervention: Ecopipam
Trial phase: Phase 2
SMILES: [H][C@@]12c3cc(O)c(Cl)cc3CCN(C)[C@@]1([H])CCc1ccccc12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 76
Group description: Participants received a targeted steady-state dose of 2 milligram per kilogram per day (mg/kg/day) of ecopipam HCl tablets orally, once daily during a titration and treatment period for a total of 12 weeks.
Eligibility criteria:
Inclusion Criteria:

≥ 6 and < 18 years of age
≥ 18 kg (~ 40 lbs.)
TS diagnosis and both motor and vocal tics that cause impairment with normal routines
Minimum score of 20 on the YGTSS-Total Tic Score
May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline.
Effective contraception during the study and 30 days after last study dose for sexually active subjects

Exclusion Criteria:

Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)
Unstable medical illness or clinically significant lab abnormalities
Risk of suicide
Pregnant or lactating women
Moderate to severe renal insufficiency
Hepatic insufficiency
Positive urine drug screen
Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder
Certain medications that would lead to drug interactions
Recent behavioral therapy
Intervention: Nalbuphine Hydrochloride
Trial phase: Phase 1
SMILES: Cl.Oc1ccc2c3c1OC1C(O)CCC4(O)C(C2)N(CC2CCC2)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: 90 mg nalbuphine HCl solution

9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage

Nalbuphine HCl solution: nalbuphine solution administered at various strengths
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects 18 to 55 years of age
Current opioid users who have used opioids for recreational (non-therapeutic) purposes

Exclusion Criteria:

Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
History or presence of any clinically significant illness
History of major mental illness that may affect the ability of the subject to participate in the study.
Intervention: Nalbuphine Hydrochloride
Trial phase: Phase 1
SMILES: Cl.Oc1ccc2c3c1OC1C(O)CCC4(O)C(C2)N(CC2CCC2)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: 120 mg nalbuphine HCl solution

12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage

Nalbuphine HCl solution: nalbuphine solution administered at various strengths
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects 18 to 55 years of age
Current opioid users who have used opioids for recreational (non-therapeutic) purposes

Exclusion Criteria:

Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
History or presence of any clinically significant illness
History of major mental illness that may affect the ability of the subject to participate in the study.
Intervention: Nalbuphine Hydrochloride
Trial phase: Phase 1
SMILES: Cl.Oc1ccc2c3c1OC1C(O)CCC4(O)C(C2)N(CC2CCC2)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: 150 mg nalbuphine HCl solution

15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage

Nalbuphine HCl solution: nalbuphine solution administered at various strengths
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects 18 to 55 years of age
Current opioid users who have used opioids for recreational (non-therapeutic) purposes

Exclusion Criteria:

Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
History or presence of any clinically significant illness
History of major mental illness that may affect the ability of the subject to participate in the study.
Intervention: Nalbuphine Hydrochloride
Trial phase: Phase 1
SMILES: Cl.Oc1ccc2c3c1OC1C(O)CCC4(O)C(C2)N(CC2CCC2)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: 180 mg nalbuphine HCl solution

18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage

Nalbuphine HCl solution: nalbuphine solution administered at various strengths
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects 18 to 55 years of age
Current opioid users who have used opioids for recreational (non-therapeutic) purposes

Exclusion Criteria:

Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
History or presence of any clinically significant illness
History of major mental illness that may affect the ability of the subject to participate in the study.
Intervention: Nalbuphine Hydrochloride
Trial phase: Phase 1
SMILES: Cl.Oc1ccc2c3c1OC1C(O)CCC4(O)C(C2)N(CC2CCC2)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: 270 mg nalbuphine HCl solution

27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage

Nalbuphine HCl solution: nalbuphine solution administered at various strengths
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects 18 to 55 years of age
Current opioid users who have used opioids for recreational (non-therapeutic) purposes

Exclusion Criteria:

Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
History or presence of any clinically significant illness
History of major mental illness that may affect the ability of the subject to participate in the study.
Intervention: Nalbuphine Hydrochloride
Trial phase: Phase 1
SMILES: Cl.Oc1ccc2c3c1OC1C(O)CCC4(O)C(C2)N(CC2CCC2)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: Up to 405 mg nalbuphine HCl solution

Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage

Nalbuphine HCl solution: nalbuphine solution administered at various strengths
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects 18 to 55 years of age
Current opioid users who have used opioids for recreational (non-therapeutic) purposes

Exclusion Criteria:

Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
History or presence of any clinically significant illness
History of major mental illness that may affect the ability of the subject to participate in the study.
Intervention: Nalbuphine Hydrochloride
Trial phase: Phase 1
SMILES: Cl.Oc1ccc2c3c1OC1C(O)CCC4(O)C(C2)N(CC2CCC2)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: Up to 540 mg nalbuphine HCl solution

Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage

Nalbuphine HCl solution: nalbuphine solution administered at various strengths
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects 18 to 55 years of age
Current opioid users who have used opioids for recreational (non-therapeutic) purposes

Exclusion Criteria:

Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
History or presence of any clinically significant illness
History of major mental illness that may affect the ability of the subject to participate in the study.
Intervention: CID 12303048
Trial phase: Phase 4
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
Eligibility criteria:
Inclusion Criteria:

Male subjects
Subjects scheduled for elective shoulder arthroplasty at the University of Washington Medical Center
Subjects between ages 18-89

Exclusion Criteria:

Subjects who self-report very sensitive skin
Subjects who are sensitive to benzoyl peroxide
Subjects who are allergic to chlorhexidine
Subjects who had recent prior use of antibiotics (or expect to use them prior to surgery)
Subjects who had recent use of acne treatment
Subjects who are not fluent in English.
Intervention: Brinzolamide
Trial phase: Phase 3
ATC code: G01AE10 | S01EC04 | S01EC54
SMILES: CCN[C@H]1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 246
Group description: Azopt ophthalmic suspension

Azopt 1% Ophthalmic Suspension: Reference product
Eligibility criteria:
Inclusion Criteria:

Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes
Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
Adequate wash-out period prior to baseline of any ocular hypotensive medication.
Baseline (Day 0/hour 0) pressure ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of pressure between the eyes no greater than 5 mm Hg.
Baseline best corrected visual acuity equivalent to 20/200 or better in each eye

Exclusion Criteria:

Females who are pregnant, breast feeding, or planning a pregnancy.
Females of childbearing potential who do not agree to utilize an adequate form of contraception
Current, or past history of, severe hepatic or renal impairment
Current, or history within two months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye
Current corneal abnormalities that would prevent accurate readings with the Goldmann applanation tonometer
Functionally significant visual field loss
Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
Use at any time prior to baseline of an intraocular corticosteroid implant
Use within one week prior to baseline of contact lens
Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid
Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy
Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid
Having undergone within six months prior to baseline any other intraocular surgery (e.g., cataract surgery)
Having undergone within twelve months prior to baseline refractive surgery, filtering surgery, or laser surgery for pressure reduction
Intervention: TERIPARATIDE
Trial phase: Phase 4
ATC code: H05AA02
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@H](C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc1ccccc1)C(=O)O)C(C)C)C(C)C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: daily subcutaneous injection teriparatide for 3 months

Teriparatide: teriparatide daily subcutaneous injection
Eligibility criteria:
Inclusion Criteria:

women aged 45+
postmenopausal
osteoporotic with high risk of fracture

Exclusion Criteria:

significant previous use of bone health modifying treatments
known congenital or acquired bone disease other than osteoporosis
significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
abnormal calcium or parathyroid hormone level
serum vitamin D <20 ng/mL or >60ng/mL
serum alkaline phosphatase above upper normal limit with no explanation
anemia (hematocrit <32%)
history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or gouty arthritis
history of urolithiasis within the last one year
excessive alcohol use or substance abuse
use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
extensive dental work involving extraction or dental implant within the past or upcoming 2 months
known sensitivity to mammalian cell-derived drug products
known contraindications to denosumab, teriparatide, or any of their excipients
known contraindications to tetracycline, demeclocycline, or other antibiotics in this drug class
continuous use of tetracycline for >1-month duration within the last 10 years
Intervention: Dalfampridine
Trial phase: Phase 2 | Phase 3
ATC code: N07XX07
SMILES: Nc1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 15mm opaque capsule containing 10mg of 4-AP

4-Aminopyridine: Single drug test for nerve continuity
Eligibility criteria:
Inclusion Criteria:

Patients with trauma involving two or less limbs where the continuity of a given peripheral nerve or nerves is unclear on presenting physical examination.
Closed soft tissue envelope obscuring direct observation of the continuity of the affected nerve.
Cognitive ability to report sensory and motor deficit during examination.
Able to complete dosing within four days (96 hours) of nerve injury diagnosis.
Able to provide informed consent
Eligible for standard of care plan of monitoring vs surgical exploration of the nerve.
Adults subject aged 18-90
Known limb trauma which resulted in nerve injury (aim 1) or post-operative/post intervention nerve injury (aim 2).
Ability to give written informed consent.
Capable of safely undergoing electrodiagnostic testing (EDX).
Availability for all testing days and main trial day.

Exclusion Criteria:

Not able to complete dosing within four days (96 hours) of nerve injury diagnosis
Distracting injury which prevents adequate examination.
Plan for surgical exploration of the nerve during the ensuing 48 hours.
Plan for surgical exploration of the nerve as part of another surgical procedure within 48 hours of evaluation.
Intoxication during examination or evidence of cognitive deficit that emerges during examination.
History of multiple sclerosis, stroke or any other diagnosed neurological disorder
History of hypersensitivity to AMPYRA® or 4-aminopyridine
Renal impairment based on calculated GFR (GFR<80 mL/min) This laboratory value is measured in all inpatient trauma patients as part of the standard of care.
History of difficult compliance with timely follow up or plan to seek care at another institution closer to home.
Patients outside the age range or unable to consent.
Patients with a known history of a seizure disorder (4AP overdose can, in selected cases, result in limited seizure activity).
Patients with a concomitant traumatic brain injury.
Patients unable to communicate return or loss of sensation.
Patients unable to exhibit motor control on the affected limb at baseline.
Patients unwilling to complete the study requirements.
Patients with injuries too extensive to isolate a single nerve(s) for testing.
Pregnancy, breastfeeding or incarcerated individuals.
Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, eg. Cimetidine.