anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Varenicline
Trial phase: Not Applicable
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 300
Group description: Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks.

varenicline: Given PO
Eligibility criteria:
Inclusion Criteria:

Cigarette smokers who call the New York State Smokers' Quitline requesting assistance with quitting smoking
State that they are under the care of a primary care physician
Are eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
Speak English

Answer "no" to the following 3 questions:

"Have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
"Have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
"Is there any reason that you cannot use varenicline/Chantix?"

Exclusion Criteria:

State that they are not under the care of a primary care physician
Are not eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
Do not speak English
Answer "yes" to the question, "have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
Answer "yes" to the question, "have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
Answer "yes" to the question, "is there any reason that you cannot use varenicline/Chantix?"
Are women who are currently pregnant
Report that they are unwilling to receive or take varenicline on screening
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 300
Group description: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.

nicotine patch
Eligibility criteria:
Inclusion Criteria:

Cigarette smokers who call the New York State Smokers' Quitline requesting assistance with quitting smoking
State that they are under the care of a primary care physician
Are eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
Speak English

Answer "no" to the following 3 questions:

"Have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
"Have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
"Is there any reason that you cannot use varenicline/Chantix?"

Exclusion Criteria:

State that they are not under the care of a primary care physician
Are not eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
Do not speak English
Answer "yes" to the question, "have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
Answer "yes" to the question, "have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
Answer "yes" to the question, "is there any reason that you cannot use varenicline/Chantix?"
Are women who are currently pregnant
Report that they are unwilling to receive or take varenicline on screening
Intervention: Humulene
Trial phase: Phase 1 | Phase 2
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
Eligibility criteria:
Inclusion Criteria:

Sickle cell disease, including sickle cell anemia (SS), sickle-hemoglobin C disease (SC), and sickle beta thalassemia disease (Sb).
Ongoing opioid analgesic therapy for chronic sickle cell disease-associated pain.
Subjects must be on a stable dose of analgesic medication (opioid or other) for at least 2 weeks before enrollment.
All men and women in this study must agree to use adequate birth control during this study. Acceptable barrier birth control methods are a male condom, female condom, diaphragm, or intra-uterine (IUD).
All women of reproductive potential (who have not reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation) must have a negative urine b-HCG pregnancy test performed before initiating the protocol-specified medication.
Prior history of use of cannabis. Subjects must have smoked cannabis on at least 6 occasions in their lifetime prior to enrollment.
Subjects will self-report abstaining from smoking or ingesting cannabis for one week prior to their enrollment into the study.
Able to understand and follow the instructions of the investigator, including completing the pain intensity rating scales.
Karnofsky Performance Scale >60.
Able and willing to provide informed consent.
Able and willing to spend two separate periods of 5 days and 4 nights in the Clinical Research Center at SFGH.

Exclusion Criteria:

Severe coronary artery disease, uncontrolled hypertension, cardiac ventricular conduction abnormalities, orthostatic mean blood pressure drop greater than 24 mmHg, severe chronic obstructive pulmonary disease.
Evidence of clinically significant hepatic or renal dysfunction based on judgment of physician.
Positive serum THC level on Day 1 of study.
Active substance abuse (e.g., alcohol or injection drugs) as determined by urine toxicity screening.
Neurologic dysfunction or psychiatric disorder severe enough to interfere with assessment of pain or sensory systems.
Current use of smoked tobacco products.
Women who are pregnant or breast-feeding may not take part in this study.
Unable to read or speak English.
Intervention: Humulene
Trial phase: Phase 1 | Phase 2
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
Eligibility criteria:
Inclusion Criteria:

Sickle cell disease, including sickle cell anemia (SS), sickle-hemoglobin C disease (SC), and sickle beta thalassemia disease (Sb).
Ongoing opioid analgesic therapy for chronic sickle cell disease-associated pain.
Subjects must be on a stable dose of analgesic medication (opioid or other) for at least 2 weeks before enrollment.
All men and women in this study must agree to use adequate birth control during this study. Acceptable barrier birth control methods are a male condom, female condom, diaphragm, or intra-uterine (IUD).
All women of reproductive potential (who have not reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation) must have a negative urine b-HCG pregnancy test performed before initiating the protocol-specified medication.
Prior history of use of cannabis. Subjects must have smoked cannabis on at least 6 occasions in their lifetime prior to enrollment.
Subjects will self-report abstaining from smoking or ingesting cannabis for one week prior to their enrollment into the study.
Able to understand and follow the instructions of the investigator, including completing the pain intensity rating scales.
Karnofsky Performance Scale >60.
Able and willing to provide informed consent.
Able and willing to spend two separate periods of 5 days and 4 nights in the Clinical Research Center at SFGH.

Exclusion Criteria:

Severe coronary artery disease, uncontrolled hypertension, cardiac ventricular conduction abnormalities, orthostatic mean blood pressure drop greater than 24 mmHg, severe chronic obstructive pulmonary disease.
Evidence of clinically significant hepatic or renal dysfunction based on judgment of physician.
Positive serum THC level on Day 1 of study.
Active substance abuse (e.g., alcohol or injection drugs) as determined by urine toxicity screening.
Neurologic dysfunction or psychiatric disorder severe enough to interfere with assessment of pain or sensory systems.
Current use of smoked tobacco products.
Women who are pregnant or breast-feeding may not take part in this study.
Unable to read or speak English.
Intervention: Bivalirudin
Trial phase: Not Applicable
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)

Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area.
Eligibility criteria:
Inclusion Criteria:

must have evidence of neck fibrosis
previous radiation treatment to the neck for cancer
age greater than or equal to 18 years
life expectancy of greater than 12 weeks
ability to understand the purpose of the study and the willingness to sign a written informed consent document.

Exclusion Criteria:

History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram.
any psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
Intervention: Dapsone
Trial phase: Phase 1
ATC code: D10AX05 | J04BA02 | J04BA50 | J04BA51
SMILES: Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of acne vulgaris
Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study
If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study
willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study

Exclusion Criteria:

Oral acne treatments within 6 months
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Eligibility criteria:
Inclusion Criteria:

ASA physical status 1 or 2 patients patients scheduled for thyroidectomy

Exclusion Criteria:

Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean
Intervention: Azilsartan medoxomil
Trial phase: Not Applicable
ATC code: C09CA09 | C09DA09
SMILES: CCOc1nc2cccc(C(=O)OCc3oc(=O)oc3C)c2n1Cc1ccc(-c2ccccc2-c2noc(=O)[nH]2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.
Eligibility criteria:
Inclusion Criteria:

Female
Ages 45-70
Post-menopause: have not had a menstrual period for one year or more
Diagnosed with Stage 1 hypertension
Body Mass Index (BMI) greater than or equal to 28

Exclusion Criteria:

Male
Diagnosed with Stage 2 hypertension
Stage 1 hypertension requiring more than one agent
Pregnancy or attempting pregnancy
Use of oral contraceptive pills
Use of hormone replacement therapy
Use of steroids
Stage 3 or greater kidney disease
Diabetes mellitus
untreated hypothyroidism or hyperthyroidism
primary hyperaldosteronism
Cushing's disease
obstructive sleep apnea
chronic illness, e.g. chronic liver disease
NYHA class III or greater heart failure
moderate to severe lung disease
Intervention: Indomethacin
Trial phase: Phase 3
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 223
Group description: Indomethacin 100 mg PR x 1 in peri-procedural period

Indomethacin: 100 mg Indomethacin PR x 1
Eligibility criteria:
Inclusion Criteria:

Scheduled for an ERCP at Dartmouth-Hitchcock
Age greater than 18 years old
Ability to provide written informed consent

Exclusion Criteria:

Inability to provide written informed consent
ERCP being performed for diagnosis and/or treatment of acute pancreatitis
Current ongoing acute pancreatitis
Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
Pregnant or nursing mothers
Intervention: Solifenacin Succinate
Trial phase: Phase 4
SMILES: O=C(O)CCC(=O)O.O=C(OC1CN2CCC1CC2)N1CCc2ccccc2C1c1ccccc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Solifenacin succinate, 5mg or 10 mg once daily

Solifenacin succinate
Eligibility criteria:
Inclusion Criteria:

Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per HIPAA Authorization for the USA test sites is obtained from subject or legally authorized representative prior to the initiation of this study (including withdrawal of prohibited medication, if applicable)
Subject must be an ambulatory male at least 18 years of age.
Subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy.
Subject is willing to complete the American Urology Association Symptom Score (AUASS) Questionnaire.

Exclusion Criteria:

Subject has undergone a prostatectomy
Subject exhibits symptoms of urinary tract infection.
Subject exhibits severe neurologic damage or has undergone prostatectomy.
Subject diagnosed with OAB and is being treated with medication for alleviation of OAB symptoms within 12 months prior to the Screening Visit.
Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent UTI.
Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other anticholinergic agents.
Subject has undergone treatment with any investigational drug within 30 days prior to screening procedure.
Subject has exhibited history of diagnosed gastrointestinal obstructive disease.
Subjects with co-morbid lower urinary tract symptoms (LUTS).
Subjects exhibiting clinically significant bladder outflow obstruction (BOO).
In the opinion of the Study Investigator, the patient has exhibited prior to the screening or Baseline visit, a clinically significant disease or medical condition that would exclude the subject from participating in the study.
Subjects who have received prior pelvic radiation.
Subjects with history of severe hepatic impairment.
Subjects with history of Congenital or Acquired QT prolongation.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Eligibility criteria:
Inclusion Criteria:

Glabellar lines and crow's feet lines
No prior use of botulinum toxin therapy of any serotype for any reason

Exclusion Criteria:

Previous facial cosmetic surgery, tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers
Planning a facial cosmetic procedure during the study period
Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, and/or amyotrophic lateral sclerosis
Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
Intervention: Azithromycin
Trial phase: Phase 2
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 60
Group description: Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days

Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days
Eligibility criteria:
Inclusion Criteria:

Gestational age 24 weeks 0 days-28weeks 6 days by best obstetrical estimate
<72 h age
Positive pressure ventilation for at least 1 hour duration during the first 72 hours of life
Presence of indwelling intravenous line for drug administration

Exclusion Criteria:

Any patient judged to be non-viable or for whom withdrawal of life support is planned
Patients with major lethal congenital anomalies
Triplets or higher order multiples
Patients delivered for maternal indications (low risk of Ureaplasma colonization)
Patients with EKG QT interval corrected for heart rate (Qtc) ≥ 450 ms
Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)
Patients exposed to other systemic macrolide
Patients with clinically suspected Ureaplasma central nervous system (CNS) infection or other confirmed bacterial/viral infection
Patients participating in other clinical trials involving investigational products.
Intervention: Cenestin
Trial phase: Phase 4
SMILES: CC12CCC3C(=CCc4cc(OS(=O)(=O)[O-])ccc43)C1CCC2=O.[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.

Premarin
Eligibility criteria:
Inclusion Criteria:

Women, still with uterus, planning total hysterectomy as part of surgical repair for pelvic organ prolapse
Symptomatic anterior and/or apical vaginal prolapse greater than or equal to Stage 2 (i.e., bulge extends to at least 1 cm of the hymen or beyond)
Women between 1 and 10 years after menopause. Menopause is defined as one year of amenorrhea or surgical ovariectomy.
Age 40-70 years old
No estrogen replacement therapy in the last 1 month
Physically capable of daily application of vaginal cream

Exclusion Criteria:

BMI >35
Prior surgical repair of prolapse involving the vaginal cuff.
Prior total hysterectomy
Premenopausal or postmenopausal >10 years
Prior steroid hormone replacement therapy of duration >1 month (oral or vaginal estrogen, testosterone or corticosteroids)
History of connective tissue disease (Ehlers-Danlos, Marfan, etc)
History of vaginal radiation
Contraindications for estrogen replacement therapy (current, or history of, spontaneous deep vein thrombosis, stroke, coronary artery disease, breast or endometrial cancer)
Concurrent use of steroid cream for treatment of Lichen sclerosis
Recent history (within last month) of vaginal infection or vaginitis
Current tobacco use
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 80
Group description: This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.

Lidocaine gel
Eligibility criteria:
Inclusion Criteria:

Age 0-3 years
English or Spanish speaking
Legal guardian present to provide consent
Medical indication for TUBC during the patient's ED visit

Exclusion Criteria:

Severe developmental delay or impaired mentation
Neural tube defect, paraplegia, or other condition altering urethral sensation
Known urethral stricture, anatomic abnormality or reconstruction
History of sexual abuse
Patient weight less than 2.3 kg
Allergy or previous adverse reaction to lidocaine
Previous enrollment in the study
Prior successful or attempted TUBC in previous 7 days
Intervention: OXYTOCIN
Trial phase: Early Phase 1
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: 12
Group description: Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.

Oxytocin: Intranasal dose of 20 IU oxytocin
Eligibility criteria:
Inclusion Criteria:

Males and females older than 18 and younger than 85 years of age
Undergoing catheter ablation for paroxysmal atrial fibrillation
Presenting in sinus rhythm at the time of their procedure

Exclusion Criteria:

Left ventricular ejection fraction <0.40
Paced rhythm >50 percent of the time by device interrogation if a pacemaker is present
Intervention: Apixaban
Trial phase: Phase 3
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
Eligibility criteria:
Inclusion Criteria:

Acute symptomatic proximal DVT with evidence of proximal thrombosis
Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches

Exclusion Criteria:

Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
Subjects requiring dual anti-platelet therapy