anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ketamine
Trial phase: Phase 3
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously

Ketamine: Ketamine 0.3 mg/kg along with ondansetron 4 mg IV
Eligibility criteria:
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion Criteria

Age 18 to 65 years who present to the ED with complaint of a headache
Temperature less than 100.4 F
Diastolic blood pressure less than 104 mm Hg
Normal neurologic exam and normal mental status

Exclusion Criteria

Pregnant or breastfeeding
Meningeal signs are present
Acute angle closure glaucoma is suspected
Head trauma within the previous two weeks
Lumbar puncture within the previous two weeks
Thunderclap (rapid) onset of the headache
Weight more than 150 kg or less than 40 kg
Known allergy to diphenhydramine
Known allergy to ondansetron. (Zofran)
Known allergy to Compazine
Known allergy to Ketamine
History of schizophrenia or bipolar disorder
History of intracranial hypertension
Is a prisoner
Patient declined informed consent
Non-English speaking patient
Attending provider excludes patient
Elderly patients with dementia
Patients with severe headaches that diminish their decision making capability will not be able to participate
Intervention: Ubenimex
Trial phase: Phase 2
SMILES: CC(C)C[C@H](NC(=O)[C@@H](O)[C@H](N)Cc1ccccc1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: ubenimex capsules 150 mg TID, administered orally, minimum of 24 weeks for all patients.

The maximum anticipated time an individual patient will participate will vary because treatment will continue until the last patient enrolled has received at least 24 weeks of open-label treatment.
Eligibility criteria:
Inclusion Criteria:

Patients must have completed Study EIG-UBX-001 through Week 24.
In the opinion of the Principal Investigator, has been generally compliant with study requirements during Study EIG-UBX-001.
Agrees to use a medically acceptable method of contraception throughout the entire study period.
Willing and able to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.

Exclusion Criteria:

Is pregnant or lactating.
Concurrent regular use of another leukotriene pathway inhibitor.

Any reason that, in the opinion of the investigator, precludes the patient from participating in the study.

Any condition that is unstable or that could jeopardize the safety of the patient and his/her compliance in the study
A serious uncontrolled medical disorder/condition that in the opinion of the investigator would impair the ability of the patient to receive protocol therapy
An ongoing, drug-related, serious adverse event (SAE).
Significant/chronic renal insufficiency.
Transaminases (alanine transaminase, aspartate transaminase) levels >3 × upper limit of normal (ULN) and/or bilirubin level >2 × ULN.
Absolute neutrophil count <1500 mm3.
Hemoglobin concentration <9 g/dL at Screening.
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 59
Group description: NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)

N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Age 18-65
Daily smoker for ≥6 months, smoking approximately ≥5 cigarettes per day on average in the past month or must meet the criteria for nicotine dependence
Be interested in quitting smoking (defined as a 2 or above on a 10-point Likert scale assessing readiness and interest in quitting (1=not at all ready/interested, 10=extremely ready/interested)
Willing to engage in a 3-day quit attempt as part of study procedures
Willing to abstain from cannabis use during study procedures (since inhaled cannabis will affect breath carbon monoxide readings).
If female, agreement to use birth control (any form) to avoid pregnancy during study procedures

Exclusion Criteria:

Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than tobacco use disorder) in the past month that may interfere with study performance based on PI judgment
Current pregnancy or breastfeeding
Current use of medications with smoking cessation efficacy
Known hypersensitivity to NAC
Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female, at least 18 years of age at time of Screening.
Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection.
Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening visit.
Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed greater than or equal to 2 months prior to Screening.

Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or equal to 500 cells/mm^3 (or CD4+ % greater than or equal to 29%) at Screening; or Subjects on a stable ART regimen must have

CD4+ count greater than or equal to 200 cells/mm^3 (or CD4+ % greater than or equal to 14%) at Screening; and
Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg).
Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female, at least 18 years of age at time of Screening.
Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection.
Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening visit.
Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed greater than or equal to 2 months prior to Screening.

Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or equal to 500 cells/mm^3 (or CD4+ % greater than or equal to 29%) at Screening; or Subjects on a stable ART regimen must have

CD4+ count greater than or equal to 200 cells/mm^3 (or CD4+ % greater than or equal to 14%) at Screening; and
Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg).
Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.
Intervention: Lidocaine
Trial phase: Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 220
Group description: If the subject is assigned to the experimental group (vaginal lidocaine jelly):

She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.

Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
Eligibility criteria:
Inclusion Criteria:

Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.

Exclusion Criteria:

Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.
Intervention: Ledipasvir
Trial phase: Phase 3
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females
Aged 20 years or older
Treatment naive or treatment experienced
At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.

Key Exclusion Criteria:

Previous exposure to an NS5A or NS5B inhibitor
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Pregnant or nursing female or male with pregnant female partner

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Ledipasvir
Trial phase: Phase 3
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Eligibility criteria:
Key Inclusion Criteria:

Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females
Aged 20 years or older
Treatment naive or treatment experienced
At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.

Key Exclusion Criteria:

Previous exposure to an NS5A or NS5B inhibitor
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Pregnant or nursing female or male with pregnant female partner

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Eplerenone
Trial phase: Not Applicable
ATC code: C03DA04
SMILES: [H][C@@]12CC[C@@]3(CCC(=O)O3)[C@@]1(C)C[C@H]1O[C@@]13[C@@]2([H])[C@H](C(=O)OC)CC1=CC(=O)CC[C@@]13C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Eplerenone: Eplerenone 50mg by mouth twice daily

Lifestyle Modification: Counseling regarding diet and healthy activity
Eligibility criteria:
Inclusion Criteria:

Ages 40-65 years
Antiretroviral use (ART) >12 months and HIV viral load <100 copies/mL
VAT> 110cm2

Exclusion Criteria:

Antihypertensive use including, ACE Inhibitor, ARB, MR blockade, diuretic, potassium (K) supplementation; or BP>140/90 mmHg. Stable use (>3 months) of beta-blockers or calcium channel blockers (CCB) (except verapamil) is allowed.
Unstable statin use <12 months. Stable use (>12 months) is allowed.
Use of full dose ritonavir, nelfinavir, clarithromycin, and other strong inhibitors of CYP3A4, as well as CYP3A4 inducers.
Continuous oral steroid use (equivalent to prednisone > 5 mg daily) within the last 3 months.
Uncontrolled diabetes requiring insulin and/or HbA1c > 7.5%.
Creatinine (Cr) > 1.5 mg/dL or estimated GFR<60 mL/min/1.73m2.
K > 5.5 mEq/L.
Hemoglobin < 10 g/dL.
Known liver disease or ALT >3x ULN.
History of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease.
Pregnant, actively seeking pregnancy or breastfeeding.
Estrogen, progestin derivative, or other sex steroid use within last 3 months. Stable physiologic testosterone replacement (> 3 months) is acceptable.
Current bacterial or other infections.
Active substance abuse.
Significant radiation exposure over the course of the year prior to randomization (e.g., radiation therapy, PCI, catheter ablation of arrhythmia) within 12 months of randomization.
Previous reaction or contraindication to iodine-containing contrast media and gadolinium.
Coronary artery luminal narrowing >70% on coronary CTA.
Intervention: Betamethasone Sodium Phosphate
Trial phase: Phase 2
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)COP(=O)([O-])[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Fluticasone propionate HFA 220: Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
Eligibility criteria:
Inclusion Criteria:

For the WTC population with Irritant-Induced Asthma (IA):

> 18 years of age*
Current nonsmoker*
< 5 pack year (p-y) history of tobacco use*
Spirometry in the past 6 months or on day of evaluation with a bronchodilator* response of ≥ 12% and 200 ml improvement in FEV*

Positive methacholine challenge test (decrease in FEV1*

≥ 20% (PC20) after inhalation of < 16 mg/ml of methacholine)

Inhaled corticosteroid use in previous 1 month or more will be allowed*
Patients will be recruited from the WTC EHC and will have WTC dust cloud exposure
New symptoms after 9/11
Symptoms of wheeze and shortness of breath (> 2x / week) in the 4 weeks before inclusion (persistent symptoms).

Inclusion for Allergic Asthma Population (AA):

All of the above items with an asterisk (*)
Patients will be recruited from the NYUBAR or advertisement and will have asthma as defined by NIH guidelines, persistent symptoms, absence of WTC dust exposure.
Participants who will have completed the Phase I of the study and were able to produce adequate sputum samples.

Inclusion of Control Population:

Patients will be recruited from the NYUBAR and will have no respiratory symptoms, no asthma diagnosis, no WTC dust exposure, no current tobacco use, ≤ 5 p-y history of tobacco use, and normal spirometry with no bronchodilator response and negative methacholine challenge in past 6 months.

Inclusion Criteria for Phase II:

Successfully completed Phase I
Has asthma according to Phase I diagnostic criteria
Signed consent to be re-contacted

Exclusion Criteria:

Current Smoker
Pulmonary diseases such as Chronic Pulmonary Disease (COPD) or Interstitial Lung Disease
Cardiac Disease
Inability to perform lung function or other maneuvers
Upper respiratory tract infection within the last 4 weeks
FEV1 <60% predicted normal pre-bronchodilator
Oral corticosteroid treatment within the last 4 weeks.
No vulnerable subjects will be part of this study.
Intervention: Tolcapone
Trial phase: Phase 2
ATC code: N04BX01
SMILES: Cc1ccc(C(=O)c2cc(O)c(O)c([N+](=O)[O-])c2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 62
Group description: Adverse Events Groups are being reported "per intervention" (e.g., "Tolcapone" and "Placebo") rather than based on group in the cross over study. Tolcapone Group here reflect all participants who received Tolcapone during the study, regardless of order.
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers who are 21-40 years of age
If female, 10 or more alcoholic drinks must be consumed weekly.
If male, 14 or more alcoholic drinks must be consumed weekly.
Meets DSM-V criteria for Alcohol Use Disorder (AUD).
If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
Ability to read and speak English.
High school graduate.
Able and willing to provide an informed consent.
Able to understand and follow the instructions of the investigator, including the delayed discounting tasks. Residing within 5 miles of the study site.

Exclusion Criteria:

Positive urine drug screen (except marijuana).
Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills. or other psychoactive drugs within 2 weeks of the start of the study (except marijuana).
Marijuana use more than 3 times/week.
Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.
Currently trying to quit alcohol use.
History of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.).
Two SGPT/ALT or SGOT/AST values greater than the upper limit of normal.
Unable to pass the Standard Field Sobriety Test in a sober state (BAC = 0.00).
BAC level >0.05% at the beginning of screening visit (within margin of error of detection).
Regular use of any of the drugs on the tolcapone contraindications list OR within 2 weeks of drug administration.
Severe low blood (< 90/50) pressure or uncontrolled high blood pressure (>160/100). Allergy or intolerance to tolcapone.
Subject has received an investigational drug within 30 days of the screening visit.
Subject is considered unsuitable for the study in the opinion of the investigator or clinician for any other reason (such as an Axis II personality disorder that makes the subject unable to comply with study instructions, per the Clinician's judgement.)
Intervention: OXYTOCIN
Trial phase: Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)

Oxytocin: Intranasal oxytocin 40 IU
Eligibility criteria:
Inclusion Criteria:

Active Duty Service Members, any service branch; age 18-65 years.
Meets clinician assessment for current PTSD OR anxiety disorder NOS OR scores on DASS > 10 on Anxiety or > 19 on Stress.
Meets clinician assessment for alcohol use disorder (AUD) OR scores >8 on AUDIT.
If meet current or lifetime criteria for another substance disorder, must indicate that AUD is primary.
Subjects taking psychotropic medications will be required to be maintained on a stable dose for at least two weeks before study initiation (unless at physician's discretion following psychological consult).
Negative urine drug screen test and BAC =0.
Able to comprehend English.
Able to provide informed consent and function at an intellectual level sufficient to allow completion of the assessment instruments.
Must consent to random assignment to oxytocin or placebo.

Exclusion Criteria:

Positive urine drug screen (except marijuana) or BAC > 0.
Untreated subjects currently symptomatic of psychotic or bipolar affective disorders.
Subjects with current suicidal or homicidal ideation and intent, who would present a serious suicide risk.
Subjects on psychotropic drugs that have been initiated during the past 2 weeks (unless approved at physician's discretion following psychological consult).
Subjects with a history of a major medical illness (e.g., endocrine, cardiovascular, central nervous system disorders, peripheral neuropathy, or pulmonary disease) or other acute or unstable medical condition that might interfere with safe conduct of the study or accurate interpretation of the results.
Subjects experiencing withdrawal symptoms as reported by Clinician or systolic BP≥160 mmHg, diastolic BP ≥100 mmHg and resting HR ≥100 bpm.
Subject is considered unsuitable for the study in the opinion of study PI or AIs for any other reason.