anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Baricitinib
Trial phase: Phase 1
ATC code: L04AA37
SMILES: CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: 10 mg baricitinib tablet administered orally once, on Day 1 in Period 1.

Adverse events are reported from baseline through predose on Day 3.
Eligibility criteria:
Inclusion Criteria:

Overtly healthy as determined by medical history and physical examination
Women not of childbearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history, or menopause
Have a body mass index of 18 to 29 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies to baricitinib, omeprazole, related compounds, or any components of the baricitinib or omeprazole formulations, or history of significant atopy
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological (including clotting disorders), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Have an absolute neutrophil count (ANC) less than 2 × 10^9 cells per liter (L) [2000 cells/microliter (μL)] at screening or Day -1. For abnormal values, a single repeat will be allowed
Intend to use over-the-counter or prescription medication (including drugs and substances known to alter gastric potential hydrogen (pH), such as proton pump inhibitors or over-the-counter antacid remedies and/or herbal supplements within 14 days prior to dosing and during the study (with the exception of hormone replacement therapy (HRT) and occasional paracetamol, which will be permitted at the discretion of the investigator), or intended use of vitamin supplements from Day 1 until discharge from the clinical research unit (CRU)
Have used or intend to use any drugs or substances that are known to be substrates, inhibitors, or inducers of cytochrome P450 3A4 (CYP3A4) within 30 days prior to dosing and throughout the study
Are unable to tolerate or unwilling to undergo insertion of a nasogastric pH probe for assessment of gastric pH during the study
Intervention: Benzocaine
Trial phase: Phase 4
ATC code: C05AD03 | D04AB04 | N01BA05 | R02AD01
SMILES: CCOC(=O)c1ccc(N)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.

Benzocaine
Eligibility criteria:
Inclusion Criteria:

All women who present to Penn Fertility Care over the age of 18 years old

Exclusion Criteria:

Patients under the age of 18
Pregnant patients
Patients with a history of hypersensitivity to benzocaine
Patients with a history of asthma or bronchitis
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: A saline placebo spray will be used in the placebo group.

Saline spray: A saline spray will be used in the placebo group
Eligibility criteria:
Inclusion Criteria:

All women who present to Penn Fertility Care over the age of 18 years old

Exclusion Criteria:

Patients under the age of 18
Pregnant patients
Patients with a history of hypersensitivity to benzocaine
Patients with a history of asthma or bronchitis
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Nicotine Replacement gum

Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling
Eligibility criteria:
Inclusion Criteria:

Smokes at least five cigarettes per day
No current or previous regular use of e-cigarettes
Ready to quit smoking

Exclusion Criteria:

Use of smokeless or pipe tobacco
Smoke more than 40 cigarettes per day
Pregnant or breastfeeding
Unable to chew gum due to dental or jaw problems
Myocardial infarction (heart attack) within the previous 12 months
Hypersensitivity to propylene glycol or nicotine gum
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 2
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.

Part 1: 2 mg of orBec 4 times per day for up to 16 weeks.

Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:

Weeks 17-24: 2 mg orBec 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg orBec 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg orBec daily, up to 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Receipt of allogeneic hematopoietic cell transplant >100 days prior to consent
Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion)
Endoscopic findings consistent with GI GVHD
Must be able to swallow tablets
Must be able to read and understand informed consent
Adequate birth control methods for the duration of the study

Exclusion Criteria:

>500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
GI infection
Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
HIV seropositivity
Pregnant or nursing female
Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug
Evidence of recurrent or progressing malignant disorder that was the indication for HCT
Intervention: Estradiol
Trial phase: Phase 2
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks

Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women
Diagnosis of hypercalciuria
Diagnosis of low bone mass
Vitamin D replete (serum 25-hydroxyvitamin D level >35 ng/mL)

Exclusion Criteria:

Secondary causes of hypercalciuria (primary hyperparathyroidism, sarcoidosis, vitamin D excess, malignant neoplasm, and renal tubular acidosis)
Other metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, hypercortisolemia, severe gastrointestinal disorders, liver cirrhosis, renal failure (Cr >1.5), active malignancy including multiple myeloma, rheumatological diseases, and Paget's disease of bone)
Use of medications affecting bone and calcium metabolism (corticosteroids in the previous 3 months, suppressive dose of thyroid hormone, calcium channel blockers, anti-convulsants, aromatase inhibitors, thiazolidinediones, and cyclosporine A)
History of coronary artery disease
Breast cancer or suspected estrogen-dependent neoplasia
Previous venous thromboembolic event
Stroke
Active liver disease
Tobacco use within the past 6 months
Negative colonoscopy within the previous 10 years or sigmoidoscopy within the previous 5 years
Negative mammogram within the previous 2 years
Negative Pap smear within the previous 3 years in women < or = 65 years old with an intact cervix
No vaginal bleeding within the prior 5 months.
Age > or = 70
> or = 20 years since last menstrual period or use of hormone replacement therapy
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Sitaglipitin tablets will be administered orally for 3 months from randomization

Initial dose will be 100mg/daily, adjusted per renal function:

Creatinine clearance > or = 50mL/min: 100mg/day Creatinine clearance > or = 30 and <50mL/min: 50mg/day Creatinine clearance <30 mL/min or on dialysis: 25mg/day

Sitagliptin
Eligibility criteria:
Inclusion Criteria:

Adult (≥18 yo) recipient of living-donor or deceased donor kidney transplant
Blood sugar ≥ 200 mg/dL in first 72 hours after transplant
No history of diabetes or prior treatment with insulin or oral hypoglycemic agents

Exclusion Criteria:

A1c of ≥6.5% measured immediately pre-transplant
Recipient of simultaneous kidney-pancreas, kidney-liver, kidney-heart, or kidney-lung transplant
Prior non-renal solid organ transplant
Intervention: Besifloxacin
Trial phase: Phase 2
ATC code: S01AE08
SMILES: N[C@@H]1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.

Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
Eligibility criteria:
Inclusion Criteria:

Patients must be between the ages of 18-90 years of age.
Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.
Patients must have a corneal ulcer greater than 2mm but less than 6mm in size.
Patients must have corneal ulcer present in only one eye.
Patients must agree not to wear contact lenses while on study.

Exclusion Criteria:

Patients with multifocal ulcers.
Signs of any other viral or fungal infection.
Treatment with antibiotics within 14 days of study entry.
Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular nonsteroidal anti-inflammatory drugs (NSAIDS) during the prior 14-day period.
Known hypersensitivity or allergy to steroids (Loteprednol etabonate) or to any of the ingredients in the three study drugs (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%).
Contact lens only with no spectacles available.
Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.
Participation in any investigational study within the past 30 days.
Pregnant women, minors, or those not able to consent for themselves.
Intervention: Gatifloxacin
Trial phase: Phase 2
ATC code: J01MA16 | S01AE06
SMILES: COc1c(N2CCNC(C)C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.

Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
Eligibility criteria:
Inclusion Criteria:

Patients must be between the ages of 18-90 years of age.
Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.
Patients must have a corneal ulcer greater than 2mm but less than 6mm in size.
Patients must have corneal ulcer present in only one eye.
Patients must agree not to wear contact lenses while on study.

Exclusion Criteria:

Patients with multifocal ulcers.
Signs of any other viral or fungal infection.
Treatment with antibiotics within 14 days of study entry.
Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular nonsteroidal anti-inflammatory drugs (NSAIDS) during the prior 14-day period.
Known hypersensitivity or allergy to steroids (Loteprednol etabonate) or to any of the ingredients in the three study drugs (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%).
Contact lens only with no spectacles available.
Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.
Participation in any investigational study within the past 30 days.
Pregnant women, minors, or those not able to consent for themselves.
Intervention: Moxifloxacin Hydrochloride
Trial phase: Phase 2
SMILES: COc1c(N2CC3CCCNC3C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.

Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
Eligibility criteria:
Inclusion Criteria:

Patients must be between the ages of 18-90 years of age.
Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.
Patients must have a corneal ulcer greater than 2mm but less than 6mm in size.
Patients must have corneal ulcer present in only one eye.
Patients must agree not to wear contact lenses while on study.

Exclusion Criteria:

Patients with multifocal ulcers.
Signs of any other viral or fungal infection.
Treatment with antibiotics within 14 days of study entry.
Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular nonsteroidal anti-inflammatory drugs (NSAIDS) during the prior 14-day period.
Known hypersensitivity or allergy to steroids (Loteprednol etabonate) or to any of the ingredients in the three study drugs (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%).
Contact lens only with no spectacles available.
Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.
Participation in any investigational study within the past 30 days.
Pregnant women, minors, or those not able to consent for themselves.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Saline will be administered at same volume of lidocaine in active arms.

saline: as described in Arm Description
Eligibility criteria:
Inclusion Criteria:

25-60 years old
men or women
any race or ethnicity
cocaine addition is primary present and lifetime drug of abuse
live locally

Exclusion Criteria:

Patients with active DSM (Diagnostic Statistical Manual)-IV other Substance Dependence (except nicotine) within the previous three months, Affective Disorder, Schizophrenic Disorders.
significant cognitive impairment (WTAR<70) (Wechsler Test of Adult Reading <70)..
use of tricyclic anti-depressants, benzodiazepines, cimetidine, mood stabilizers, opioids, lithium, sympathomimetics, anticonvulsants, sedative/hypnotics, β-blockers, or dopamine agonists will be excluded from the study.
Medical conditions that might limit cooperation (e.g. dementia) or put the patient at medical risk (i.e. significant hematologic, hepatic, renal, or cardiovascular pathology - particularly arrhythmias) will be excluded.
Patients with congenital or idiopathic methemoglobinemia or patients taking medications associated with increased risk of methemoglobinemia (including sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, paraaminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine) will be excluded.
Patients with past or present neurologic disorders (i.e. severe head trauma, transient ischemic attacks, stroke, tumor, etc.) will be excluded. - Active suicidal ideation, pregnant or nursing women, and prisoners will be excluded from the study.
Intervention: Ciprofloxacin
Trial phase: Not Applicable
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.

Ciprofloxacin 500mg by mouth twice a day for three days.

Ciprofloxacin
Eligibility criteria:
Inclusion Criteria:

Patients between the age of 18-90 who present for an EUS / pancreas cyst evaluation

Exclusion Criteria:

Patients outside the age range
Patient-related factors (unable to provide consent, unable to understand English, allergic to cipro)
High-risk patients for infective endocarditis
Bacterial infection or use of antibiotics within 6 weeks of EUS
Pancreatitis within the past 6 months
Underlying immunosuppression (for example, uncontrolled diabetes - such as hemoglobin A1c above 7 or glucose > 180; renal failure; cirrhosis; pre-existing malignancy especially hematologic malignancy such as leukemia / lymphoma / multiple myeloma; HIV/AIDS)
Currently taking immunosuppressive medications (for conditions such as rheumatoid arthritis, inflammatory bowel disease, organ transplant)
Radiographic or endosonographic evidence of cyst cavity debris / necrotic debris
Severe systemic disease (for example, NYHA class III or IV heart failure, oxygen-dependent COPD)
Intervention: Stribild
Trial phase: Not Applicable
SMILES: CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.CC(C)c1nc(CN(C)C(=O)NC(CCN2CCOCC2)C(=O)NC(CCC(Cc2ccccc2)NC(=O)OCc2cncs2)Cc2ccccc2)cs1.COc1cc2c(cc1Cc1cccc(Cl)c1F)c(=O)c(C(=O)O)cn2C(CO)C(C)C.Nc1nc(=O)n(C2CSC(CO)O2)cc1F.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Single-arm with switch from baseline antiretroviral therapy with Atripla to Stribild for total of 8 weeks.

Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir): Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks
Eligibility criteria:
Inclusion Criteria:

Chronic HIV-infected individuals on suppressive regimen with EFV/FTC/TDF, for at least 6 months
Undetectable HIV-1 RNA virus load for at least 6 months
No co-infections with active hepatitis B and C
Presence of at least moderate symptoms on 2 out of 3 subcores on the DASS
No known active HIV-related and non-HIV related CNS infections
Estimated glomerular filtration rate (EGFR) >60 ml/min
Consent to switching to EVG/COBI/FTC/TDF
Ages 18 - 65

Exclusion Criteria:

History of CNS opportunistic infections or active CNS infections
History of severe psychiatric disorder (excluding depression and anxiety)
History of chronic neurological disorders, such as epilepsy or multiple sclerosis
History of or current significant substance abuse or dependence and/or heavy alcohol use (>12 oz/wk)
Any women who may be pregnant (positive urine pregnancy test or unprotected sex in 2 weeks prior to scan) or known to be pregnant
Contraindications to undergoing fMRI, including metallic implants, claustrophobia, and medical conditions or medications that significantly affect cerebral blood flow or function.
Intervention: Sevoflurane
Trial phase: Phase 4
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: 1 MAC Sevoflurane inhalation is given after first measurement of lap workspace

Sevoflurane: 1 MAC sevoflurane inhalation is given
Eligibility criteria:
Inclusion Criteria:

1. Laparoscopic bariatric surgery in a patient older than 18 years of age without previous laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric bypass

Exclusion Criteria:

Allergies or contraindications to the use of one or more of the following drugs: propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane
History of a laparotomy
Emergency laparoscopy
Intervention: Remifentanil
Trial phase: Phase 4
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: remifentanyl infusion is given after first measurement of lap workspace

remifentanyl: remifentanyl is given in infusion
Eligibility criteria:
Inclusion Criteria:

1. Laparoscopic bariatric surgery in a patient older than 18 years of age without previous laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric bypass

Exclusion Criteria:

Allergies or contraindications to the use of one or more of the following drugs: propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane
History of a laparotomy
Emergency laparoscopy