anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Difamilast
Trial phase: Phase 3
SMILES: CCOc1ccccc1C(=O)NCc1coc(-c2ccc(OC(F)F)c(OC(C)C)c2)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 83
Group description: Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of AD based on the Japanese Dermatological Association's criteria
Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Intervention: Difamilast
Trial phase: Phase 3
SMILES: CCOc1ccccc1C(=O)NCc1coc(-c2ccc(OC(F)F)c(OC(C)C)c2)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 85
Group description: Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of AD based on the Japanese Dermatological Association's criteria
Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 4
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 72
Group description: 0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
Eligibility criteria:
Inclusion Criteria:

Patients undergoing total shoulder arthroplasty;
Patients who consent to be randomized.

Exclusion Criteria:

Patients younger than 18 and older than 75;
Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
Patients who are allergic to oxycodone;
Patients who are unable to speak English;
Patients with diagnosed or self---reported cognitive dysfunction;
Patients with a history of neurologic disorder that can interfere with pain sensation;
Patients with a history of drug or recorded alcohol abuse;
Patients who are unable to understand or follow instructions;
Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
Patients with BMI over 40;
Any patient that the investigators feel cannot comply with all study related procedures;
NYU Langone Health students, residents, faculty or staff members
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: 78
Group description: Administered in an Interscalene block for TSA

Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
Eligibility criteria:
Inclusion Criteria:

Patients undergoing total shoulder arthroplasty;
Patients who consent to be randomized.

Exclusion Criteria:

Patients younger than 18 and older than 75;
Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
Patients who are allergic to oxycodone;
Patients who are unable to speak English;
Patients with diagnosed or self---reported cognitive dysfunction;
Patients with a history of neurologic disorder that can interfere with pain sensation;
Patients with a history of drug or recorded alcohol abuse;
Patients who are unable to understand or follow instructions;
Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
Patients with BMI over 40;
Any patient that the investigators feel cannot comply with all study related procedures;
NYU Langone Health students, residents, faculty or staff members
Intervention: Roflumilast
Trial phase: Phase 2
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Participants apply roflumilast cream 0.05% QD for 28 days.

Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application
Eligibility criteria:
Inclusion Criteria:

Participants legally competent to sign and give informed consent or, in the case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local laws.
Males and females ages 12 years and older (inclusive) at the time of consent.
Clinical diagnosis of active atopic dermatitis for at least 6 months.
BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline.
vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' ('2') or 'moderate ('3') at Baseline.
EASI (Eczema Area and Severity Index) score of ≥ 5 at Baseline.
Females of childbearing potential must have a negative serum pregnancy test at Screening and, if sexually active, agree to use birth control throughout the trial.
In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests.

Exclusion Criteria:

Subjects with any serious medical condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
Evidence of skin conditions other than AD (atopic dermatitis) that would interfere with evaluation of the effect of the study medication.
Pregnant or lactating women or women planning to become pregnant during the study.
Known allergies to excipients in ARQ-151 cream.
Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors .
Subjects who are unwilling to refrain from using a tanning bed as well as outdoor tanning or excessive sun exposure.
Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies for the treatment of AD.

Known or suspected:

severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C)
history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
within last 5 years, a history of severe depression, suicidal ideation
Previous treatment with ARQ-151.
Subjects with a history of chronic alcohol or drug abuse in past 6 months.
Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
Subjects with a history of a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
Subjects with any condition which makes them unsuitable for clinical study participation or are family members of the clinical study site, clinical study staff, sponsor, or family members of enrolled subjects.
Intervention: Roflumilast
Trial phase: Phase 2
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Participants apply roflumilast cream 0.15% QD for 28 days.

Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application
Eligibility criteria:
Inclusion Criteria:

Participants legally competent to sign and give informed consent or, in the case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local laws.
Males and females ages 12 years and older (inclusive) at the time of consent.
Clinical diagnosis of active atopic dermatitis for at least 6 months.
BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline.
vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' ('2') or 'moderate ('3') at Baseline.
EASI (Eczema Area and Severity Index) score of ≥ 5 at Baseline.
Females of childbearing potential must have a negative serum pregnancy test at Screening and, if sexually active, agree to use birth control throughout the trial.
In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests.

Exclusion Criteria:

Subjects with any serious medical condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
Evidence of skin conditions other than AD (atopic dermatitis) that would interfere with evaluation of the effect of the study medication.
Pregnant or lactating women or women planning to become pregnant during the study.
Known allergies to excipients in ARQ-151 cream.
Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors .
Subjects who are unwilling to refrain from using a tanning bed as well as outdoor tanning or excessive sun exposure.
Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies for the treatment of AD.

Known or suspected:

severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C)
history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
within last 5 years, a history of severe depression, suicidal ideation
Previous treatment with ARQ-151.
Subjects with a history of chronic alcohol or drug abuse in past 6 months.
Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
Subjects with a history of a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
Subjects with any condition which makes them unsuitable for clinical study participation or are family members of the clinical study site, clinical study staff, sponsor, or family members of enrolled subjects.
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: No
Participants at risk: 1
Group description: No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area.

Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area
Eligibility criteria:
Inclusion Criteria:

Patients 18 years of age or older
Patients undergoing elective primary ankle or hindfoot surgery (ankle arthrodesis, subtalar arthrodesis, triple arthrodesis, total ankle arthroplasty, peroneal tendon debridement/transfer, Cavus Reconstruction, Medial Displacement Calcaneal Osteotomy, Dwyer Osteotomy)

Exclusion Criteria:

Patients who are undergoing revision surgical procedure
Patients who have taken opioid pain medications in the past 3 months prior to surgical procedure
Patients who have allergies to any of the medications or components of medications investigated in the study
Patients currently incarcerated
Patients who cannot read and speak English
Intervention: Eplerenone
Trial phase: Early Phase 1
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: 12
Group description: Eplerenone 50 mg daily administered orally to subjects
Eligibility criteria:
Enroll 10 subjects with hypertension and abnormal hemodynamics after TAVR.

This is a greater than minimal risk study.

Inclusion criteria:

TAVR procedure performed at the Malcom Randall VA Medical Center within the last 2 years.
Intracardiac pressures recorded 5 to 10 minutes after TAVR and AVi < 0.6 mm Hg/bpm.
History of hypertension, taking anti-hypertensive medications, or recent systolic blood pressure ≥130 mm Hg.

Exclusion criteria:

Serum potassium >5.5 mEq/L at initiation.
Concomitant administration of strong CYP3A inhibitor (i.e. ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir).
Type 2 diabetes with microalbuminuria.
Serum creatinine >2.0 for men and >1.8 for women.
Creatinine clearance <50 cc/min.
Concomitant administration of potassium supplements or potassium-sparing diuretics.

Subjects who are eligible to participate and signed an informed consent will be given eplerenone 50 mg daily. Study drug (eplerenone) will be paid by the North Florida Foundation for Research and Education for the duration of the study.

a. Down-titration or termination of non-essential anti-hypertensive agents is permissible so that eplerenone does not result in hypotension. Essential medications are as follows:

Angiotensin converting enzyme inhibitors (ACE-inhibitors) or angiotensin receptor blockers, if intolerant to ACE-inhibitors are indicated for treatment left ventricular dysfunction (i.e. left ventricular ejection fraction ≤40%), diabetes, and proteinuric chronic kidney disease.
Beta-blockers are indicated 3 years after an acute myocardial infarction, unless there is persistent left ventricular dysfunction (i.e. left ventricular ejection fraction ≤40%).

Monitoring.

a. Serum potassium within the last 30 days is required before initiating eplerenone. Repeat blood draw is required within the first week, and one month after the start of treatment with eplerenone.

Quality of life questionnaire. a. The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be administered at baseline and 8 weeks. The KCCQ-12 instrument will be mailed to the subject. Study coordinator will call the subject at 8 weeks to confirm vital status, assess if any adverse reactions from eplerenone, and provide assistance to completing the KCCQ-12, if needed.
Intervention: Bumetanide
Trial phase: Phase 2
ATC code: C03CA02 | C03CB02 | C03EB02 | G01AE10
SMILES: CCCCNc1cc(C(=O)O)cc(S(N)(=O)=O)c1Oc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: This group will receive 3 milligrams of bumetanide per day for a week plus placebo (starch) that will simulate the chlorthalidone dose of the treatment group. In case the dose is well tolerated, the dose of bumetanide will be increased to 4 milligrams per day.

Bumetanide: Bumetanide
Eligibility criteria:
Inclusion Criteria:

glomerular filtration rate less than 30 ml / min / 1.73m
Without replacement therapy (dialysis or hemodialysis)
Volume overload
At least 100 ml per day of residual diuresis
Use of a loop diuretic for at least one month

Exclusion Criteria:

Allergies known to diuretics
Patients with severe infections
Patients with hemodynamic instability
Amputees
Patients with cognitive impairment
Patients with acute renal failure
Patients with graft loss
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 137
Group description: Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period
Eligibility criteria:
Inclusion Criteria:

Subject's parent/legal representative must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
Subject meets DSM-5 criteria for a primary diagnosis of GAD at screening established by a comprehensive psychiatric evaluation and confirmed/supported using the Mini-International Neuropsychiatric Interview for children and adolescents (MINI Kid).
Male subjects who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.
Female subjects who are sexually active and are of childbearing potential must use, with their partner, an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.
Female subjects who are not of childbearing potential do not need to use any methods of contraception. This includes preadolescent and adolescent females who have not reached menarche. - Subject must have venous access enough to allow blood sampling and be compliant with blood draws as per the protocol.

Exclusion Criteria:

Current diagnosis of MDD, attention-deficit/hyperactivity disorder, or lifetime diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, feeding and/or eating disorder, obsessive-compulsive disorder, conduct disorder, oppositional defiant disorder, post-traumatic stress disorder, panic disorder, or pervasive development disorder.
Suspected or previously diagnosed intellectual disability disorder.
One or more first-degree relatives with diagnosed bipolar I disorder.
History of seizure disorder (other than febrile seizures).
History of electroconvulsive therapy at any time during the subject's lifetime.
Known hypersensitivity to escitalopram (escitalopram oxalate) or citalopram or any of the inactive ingredients or had frequent or severe allergic reactions to multiple medications.
Taking any medications that are contraindicated to escitalopram (escitalopram oxalate).
Inability to speak, read, or understand English well enough to complete the assessments.
No active suicidal ideation or lifetime history of suicidal behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
Intervention: Deucravacitinib
Trial phase: Phase 3
ATC code: L04AA56 | L04AF07
SMILES: CNC(=O)c1nnc(NC(=O)C2CC2)cc1Nc1cccc(-c2ncn(C)n2)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Deucravacitinib (BMS-986165) 6 mg once daily (QD)
Eligibility criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

a. For participants with plaque psoriasis: i. Stable plaque psoriasis for at least 6 months ii. Moderate to severe disease iii. Candidate for phototherapy or systemic therapy b. Additional protocol-specified inclusion criteria apply for subjects with psoriatic arthritis, erythrodermic psoriasis, or generalized pustular psoriasis

Exclusion Criteria:

Guttate, inverse, or drug-induced psoriasis at Screening or Baseline
History of recent infection
Prior exposure to BMS-986165

Other protocol defined inclusion/exclusion criteria could apply
Intervention: FLUTICASONE PROPIONATE
Trial phase: Phase 2
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: NCX 4251 Ophthalmic Suspension, 0.1% once daily for 14 days

Fluticasone Propionate: NCX 4251 Ophthalmic Suspension, 0.1%
Eligibility criteria:
Inclusion Criteria:

history of blepharitis and meet qualifying criteria for an acute exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits
have a qualifying best-corrected visual acuity

Exclusion Criteria:

abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid surgery
IOP > 21 mmHg at Screening or Baseline/Day 1 Visits
use of steroids in the past 30 days or retinoids in the past 12 months
uncontrolled systemic disease
Intervention: Pregabalin
Trial phase: Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 300mg pregabalin, PO, once, 1 hr before surgery

Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Eligibility criteria:
Subject Population Undergoing elective ureteroscopy with stent placement by Dr. Murray at University of Missouri Hospital and affiliated facilities

Subject Inclusion

Age >= 18 years

Subject Exclusion

Renal insufficiency (eGFR < 30 mL/minute/1.73 m2)
Chronic indwelling ureteral stent
Chronic opioid use
History of opioid abuse
Chronic gabapentinoid use
Plan for inpatient hospitalization
Pregnancy
Inability of the patient to consent for themselves in English
Allergy to gabapentinoid
Liver failure or hepatic dysfunction
Intervention: Vancomycin
Trial phase: Phase 4
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: patients will receive hand mixed vancomycin cement

hand mixed vancomycin: hand mixed vancomycin powder into cement
Eligibility criteria:
Inclusion Criteria:

Age over 18
Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.

Primary diagnosis of knee osteoarthritis

Exclusion Criteria:
Diminished mental capacity
Vancomycin allergy
Tobramycin allergy
Patient history requiring IV administration of vancomycin or tobramycin perioperatively
Chronic kidney disease stage III and stage IV
Intervention: Epigallocatechin Gallate
Trial phase: Early Phase 1
SMILES: O=C(O[C@@H]1Cc2c(O)cc(O)cc2O[C@@H]1c1cc(O)c(O)c(O)c1)c1cc(O)c(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: Teavigo EGCG capsule containing 94% EGCG, 150 mg EGCG/capsule

Healthy volunteers: 450 mg Epigallocatechin-3-gallate (EGCG) capsules administered once daily by mouth
Eligibility criteria:
Inclusion Criteria:

Part 1: healthy volunteers
Part 2:
study will consist of patients presenting to the UCSF interstitial lung disease (ILD) outpatient clinic with imaging indicative of lung fibrosis but of uncertain classification, and who are willing to take EGCG for a minimum of 2 weeks prior to surgery.

Exclusion Criteria:

co-morbidities affect hepatic function, such as HCV infection, cirrhosis, or
using drugs with significant hepatic toxicities
Intervention: Epigallocatechin Gallate
Trial phase: Early Phase 1
SMILES: O=C(O[C@@H]1Cc2c(O)cc(O)cc2O[C@@H]1c1cc(O)c(O)c(O)c1)c1cc(O)c(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: Teavigo EGCG capsule containing 94% EGCG, 150 mg EGCG/capsule

Healthy volunteers: 600 mg Epigallocatechin-3-gallate (EGCG) capsules administered once daily by mouth
Eligibility criteria:
Inclusion Criteria:

Part 1: healthy volunteers
Part 2:
study will consist of patients presenting to the UCSF interstitial lung disease (ILD) outpatient clinic with imaging indicative of lung fibrosis but of uncertain classification, and who are willing to take EGCG for a minimum of 2 weeks prior to surgery.

Exclusion Criteria:

co-morbidities affect hepatic function, such as HCV infection, cirrhosis, or
using drugs with significant hepatic toxicities