bioihbjkbjnl/mcl2 huggingface dataset:
Mental Stress Reduction in Defibrillator Patients
Condition: Cardiomyopathy, Dilated; Arrhythmia; Anger; Stress
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated; Stress, Psychological
Intervention: Cognitive Behavioral Stress Management (CBSM); Patient Education
Intervention description: 10 week program of weekly CBSM therapy group sessions; 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 21 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Stress, Psychological; Tachycardia, Ventricular; Defibrillators, Implantable; Death, Sudden Cardiac; Cognitive Therapy; Anger

Summary:

      The purpose of this study is to assess the effectiveness of a 10 week program of Stress
      Management versus control Patient Education sessions on cardiac responses to mental stress in
      veterans with Implantable Cardioverter-Defibrillators
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >21 years,

          -  ICD Implantation,

          -  > 3 months following ICD implantation,

          -  willingness to give informed consent

        Exclusion Criteria:

          -  Episodes within prior 3 months of: acute coronary syndrome, myocardial infraction,
             Coronary Artery By-pass Graft surgery, percutaneous coronary intervention, hospital
             admission any cause,

          -  severe mental illness,

          -  life expectancy < 1 year,

          -  hyperkalemia,

          -  hypokalemia,

          -  hypomagnesemia,

          -  hypermagnesemia,

          -  unwillingness to give informed consent
A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
Condition: Obesity
MeSH terms: Obesity
Intervention: VI-0521; VI-0521; topiramate; topiramate; phentermine; phentermine; VI-0521
Intervention description: phentermine 15 mg and topiramate 92 mg, po once daily; phentermine 7.5 mg and topiramate 46 mg, po once daily; topiramate 46 mg, po once daily; topiramate 92 mg, po once daily; phentermine 7.5 mg, po once daily; phentermine 15 mg, po once daily; placebo, po once daily
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 756.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of various doses of
      VI-0521 compared to both placebo, and the single-agent components that comprise each
      combination dose. This study will provide confirmatory data to demonstrate that doses of
      VI-0521 have efficacy that is greater than placebo and each of the single-agent components
      that comprise the combination dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2

          -  Informed Consent

          -  Females of child-bearing potential must be using adequate contraception

        Exclusion Criteria:

          -  Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months

          -  Clinically significant renal, hepatic or psychiatric disease

          -  Unstable thyroid disease or replacement therapy

          -  Nephrolithiasis

          -  Obesity of known genetic or endocrine origin

          -  Participation in a formal weight loss program or lifestyle intervention

          -  Glaucoma or elevated intraocular pressure

          -  Pregnancy or breastfeeding

          -  Drug or Alcohol abuse

          -  Smoking cessation within previous 3 months or plans to quit smoking during study

          -  Eating disorders within past year

          -  Cholelithiasis within past 6 months

          -  Type 2 diabetes

          -  Previous bariatric surgery

          -  Bipolar disorder or psychosis

          -  Steroid hormone therapy not stable for 3 months

          -  Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: CT-P13 SC (Infliximab); Placebo SC
Intervention description: Subcutaneous injection of CT-P13 SC; Subcutaneous injection of Placebo SC
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 548.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC
      over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female aged 18 to 75 years, inclusive.

          -  Patient has moderately to severely active UC with a modified Mayo score of 5 to 9
             points with endoscopic subscore of ≥ 2 points

        Exclusion Criteria:

          -  Patient who has previously received 2 or more biologic agents and/or JAK inhibitors

          -  Patient who has previously received either a TNFα inhibitor or biologic agent within 5
             half-lives
Confirmatory Study Nepafenac 0.3%
Condition: Cataract
MeSH terms: Cataract
Intervention: Nepafenac Ophthalmic Suspension, 0.3%; Nepafenac Ophthalmic Suspension, 0.1%; Nepafenac Ophthalmic Suspension 0.3% Vehicle; NEVANAC Vehicle
Intervention description: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.; Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days; Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.; Nepafenac vehicle, one drop in affected eye three times daily, for 16 days
Intervention MeSH terms: Nepafenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to assess the safety and efficacy of an investigational eye
      drop intended for the prevention and treatment of inflammation (swelling and redness) and
      pain in the eye after cataract extraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned cataract extraction by phacoemulsification with the implantation of a
             posterior chamber intraocular lens;

          -  Patients who, in the opinion of the Investigator, would have improvement in
             best-corrected visual acuity after surgery;

          -  Able to understand and sign an informed consent;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within
             7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100
             mg) prior to surgery and through study exit;

          -  Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery
             and through study exit;

          -  History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis,
             uveitis, iridocyclitis, rubeosis iridis) in the operative eye;

          -  Diabetic retinopathy in the operative eye;

          -  Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory
             drugs (NSAIDs), or to any component of the test article;

          -  Other protocol-defined exclusion criteria may apply.
A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo; Adalimumab
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Adalimumab; Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis

Summary:

      The main purpose of this study is to evaluate the safety and efficacy of the study drug known
      as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive
      participants with radiographic axial spondyloarthritis (rad-axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are ambulatory.

          -  Diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined
             radiographically according to the modified New York criteria.

          -  Participants have a history of back pain ≥3 months with age at onset <45 years.

          -  In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory
             drugs (for duration 4 weeks) or cannot tolerate NSAIDS.

          -  If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization.

          -  Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

        Exclusion Criteria:

          -  Have total ankylosis of the spine.

          -  Have received any prior, or are currently receiving, treatment with biologics, tumor
             necrosis factor inhibitors or other immunomodulatory agents.

          -  Have recently received a live vaccine within 12 weeks or have had a vaccination with
             Bacillus Calmette-Guerin (BCG) within the past year.

          -  Have an ongoing or serious infection within the last 12 weeks or evidence of active
             tuberculosis.

          -  Have a compromised immune system.

          -  Have any other serious and/or uncontrolled diseases.

          -  Have either a current diagnosis or a recent history of malignant disease.

          -  Have had major surgery within 8 weeks of baseline, or will require surgery during the
             study.

          -  Are pregnant or breastfeeding.
Mycotic Ulcer Treatment Trial I
Condition: Corneal Ulcer; Eye Infections, Fungal
MeSH terms: Corneal Ulcer; Eye Infections; Mycoses; Eye Infections, Fungal; Ulcer
Intervention: Natamycin; Voriconazole
Intervention description: 5% natamycin plus 0.02% preservative, one drop to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until 3 weeks after enrollment.; 1% voriconazole plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.
Intervention MeSH terms: Voriconazole; Natamycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Fungal Infections; Eye Disease; Fungal Keratitis; Visual Acuity

Summary:

      The purpose of this study is to determine if natamycin or voriconazole results in better
      visual outcomes in fungal corneal ulcers, especially visual acuity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of a corneal ulcer at presentation

          -  Evidence of filamentous fungus on smear (KOH wet mount, Giemsa, or Gram stain)

          -  Visual acuity between 6/12 (20/40, logMAR 0.3) and 6/120 (20/400, logMAR 1.3)

          -  The patient must be able to verbalize a basic understanding of the study after it is
             explained to the patient, as determined by physician examiner. This understanding must
             include a commitment to return for follow-up visits.

          -  Willingness to be treated as an inpatient or to be treated as an outpatient and return
             every 3 days +/- 1 day until re-epithelialization and every week to receive fresh
             medication for 3 weeks

          -  Appropriate consent

        Exclusion Criteria:

          -  Impending perforation

          -  Evidence of bacteria on Gram stain at the time of enrollment

          -  Evidence of acanthamoeba by stain

          -  Evidence of herpetic keratitis by history or exam

          -  Corneal scar not easily distinguishable from current ulcer

          -  Age less than 16 years (before 16th birthday)

          -  Bilateral ulcers

          -  Previous penetrating keratoplasty in the affected eye

          -  Pregnancy (by history or urine test) or breast feeding (by history)

          -  Acuity worse than 6/60 (2/200) in the fellow eye (note that any acuity, uncorrected,
             corrected, pinhole, or BSCVA 6/60 or better qualifies for enrollment)

          -  Acuity worse than 6/120 (20/400) or better than 6/12 (20/40) in the study eye (note
             that any acuity, uncorrected, corrected, pinhole, or BSCVA can be used for enrollment)

          -  Known allergy to study medications (antifungal or preservative)

          -  No light perception in the affected eye

          -  Not willing to participate
Efficacy Study of Patient Preoperative Preps In-vivo
Condition: Surgical Skin Preparation
Intervention: CHG/IPA Surgical skin preparation; Normal saline
Intervention description: Apply topically to the inguinal region for 2 minutes; Apply topically to the inguinal region for 2 minutes
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the antimicrobial efficacy of an investigational
      CHG/IPA prep on skin flora of the inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good health

          -  Minimum skin flora baseline requirements on inguinal region

        Exclusion Criteria:

          -  Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin
             disorders (including acne) on the applicable test area

          -  Topical antimicrobial exposure within 14 days prior to screening and treatment days

          -  Use of systemic or topical antibiotics, steroid medications, or any other products
             known to affect the normal microbial flora of the skin within 14 days prior to
             screening and treatment days
An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)
Condition: Hyperlipidemia; Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Niacin ER/Simvastatin Tablets; atorvastatin
Intervention description: Up to 2000 mg/40 mg at bedtime; 40 mg at bedtime
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Atorvastatin; Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin
      (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating
      effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are
      currently off lipid-modifying therapy. This was a prospective, randomized, open-label,
      blinded endpoint (PROBE) study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must meet all of the following laboratory criteria:

               -  HDL-C <40 mg/dL for men and <50 mg/dL for women.

               -  LDL-C ≥130 mg/dL but <250 mg/dL.

               -  TG <350 mg/dL.

               -  Creatine phosphokinase (CPK) < 3 x upper limit of normal (ULN).

               -  Alanine aminotransferase (ALT); serum glutamic pyruvic transaminase [SGPT] and
                  aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase [SGOT]
                  < 1.3 x ULN.

          -  Subjects must also be reasonably compliant with the Therapeutic Lifestyle Changes
             (TLC) diet during the 4 to 5 week Screening Period prior to randomization (and be
             willing to comply for the duration of the study).

        Exclusion Criteria:

          -  Subjects who have a history of any important medical conditions or abnormalities (as
             specified in the protocol) that would preclude study inclusion
Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Bexagliflozin; Placebo for Bexagliflozin; Glimepiride; Placebo for Glimepiride
Intervention description: 20 mg, tablet; inactive tablet to match active comparator bexagliflozin; 2, 4 or 6 mg, capsule; inactive capsules to match active comparator glimepiride
Intervention MeSH terms: Glimepiride; Bexagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the effect of bexagliflozin compared to
      glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in
      subjects with type 2 diabetes mellitus (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of T2DM

          -  Currently taking metformin or taking metformin and one additional oral medication for
             diabetes

          -  Body Mass Index (BMI) ≤ 45 kg/m2

          -  Stable dose of blood pressure or cholesterol medications (if applicable) for at least
             30 days

        Exclusion Criteria:

          -  Hypersensitivity or other contraindication to the safe use of sulfonylurea or
             glimepiride

          -  Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young

          -  Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor
             agonist therapy) or thiazolidinedione class drugs

          -  History of genitourinary tract infections

          -  Evidence of abnormal liver function

          -  Myocardial infarction, stroke or hospitalization for heart failure within 3 months of
             screening

          -  Prior kidney transplant or evidence of kidney problems

          -  Pregnant or nursing
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Condition: Bilateral Middle Ear Effusion
MeSH terms: Otitis Media with Effusion
Intervention: OTO-201
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with
      bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will
      receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the
      middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The
      study is designed to characterize safety and any procedural issues associated with TTT drug
      administration of OTO-201.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 17 years, inclusive

          -  Subject has a clinical diagnosis of bilateral middle ear effusion requiring
             tympanostomy tube placement

          -  Subject's caregiver is willing to comply with the protocol an attend all study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has a history of prior ear or mastoid surgery, not including myringotomy or
             myringotomy with tympanostomy tube placement

          -  Subject has a history of sensorineural hearing loss

          -  Subject has been designated for any other surgical procedure that would occur
             concurrently with TT placement, such as, but not limited to adenoidectomy or
             tonsillectomy
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Intervention: Dasiglucagon; Placebo
Intervention description: Glucagon analogue; Placebo for dasiglucagon
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: glucagon

Summary:

      A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety
      of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes
      mellitus (T1DM) compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined
             by the American Diabetes Association (3).

          -  Treated with insulin for T1DM for at least 1 year and with stable insulin treatment
             (defined as no more than a 10-unit daily variation in total daily insulin dose) 30
             days prior to screening

          -  Hemoglobin A1c <10%.

          -  Aged between 18 and 75 years, both inclusive.

        Exclusion Criteria:

          -  Previous participation in a clinical trial within the dasiglucagon in the rescue
             treatment of hypoglycemia program.

          -  Known or suspected allergy to trial drug(s) or related products.

          -  History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).

          -  Previous participation in this trial. Participation being defined by signing the
             informed consent document.