bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
Condition: Diabetes Mellitus, Type 2; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin; Placebo
Intervention description: One 100 mg over-encapsulated tablet orally once daily; One matching placebo capsule orally (by mouth) once daily
Intervention MeSH terms: Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4401.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Diabetic Nephropathies; Canagliflozin; JNJ-28431754; End-Stage Kidney Disease; Chronic Kidney Disease; Macroalbuminuria

Summary:

      The goal of this study is to assess whether canagliflozin has a renal and vascular protective
      effect in reducing the progression of renal impairment relative to placebo in participants
      with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and
      macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled
      daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor
      blocker (ARB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) greater than or equal to (>=)
             6.5 percent (%) and less than or equal to (<=) 12.0%, with an estimated glomerular
             filtration rate (eGFR) of >= 30 milliliter (mL)/minute (min)/1.73meter (m)^2 and less
             than (<) 90 mL/min/1.73 m^2

          -  Participants need to be on a stable maximum tolerated labeled daily dose of an
             angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
             for at least 4 weeks prior to randomization

          -  Must have a urine albumin to creatinine ratio (UACR) of greater than (>) 300 milligram
             (mg)/gram (g) and <= 5000 mg/g

        Exclusion Criteria:

          -  History of diabetic ketoacidosis or type 1 diabetes mellitus

          -  History of hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Renal disease that required treatment with immunosuppressive therapy

          -  Known significant liver disease

          -  Current or history of New York Heart Association (NYHA) Class IV heart failure

          -  Blood potassium level >5.5 millimole (mmol)/liter (L) during Screening
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
Condition: HOCM, Hypertrophic Obstructive Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Intervention: Mavacamten; Placebo
Intervention description: Mavacamten Capsules Other names: MYK-461; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a parallel group treatment study with 2 treatment groups; subjects and investigators are blinded to treatment and dose for the first 16 weeks of treatment. Mavacamten dose is blinded throughout the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, multi-center study in the United
      States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of
      septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive
      hypertrophic cardiomyopathy (oHCM [also known as HOCM]) who are eligible for SRT based on
      ACCF/AHA 2011 and/or ESC 2014 guidelines.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  At least 18 years old at screening and body weight > 45 kg at screening

          -  Diagnosed with oHCM consistent with current ACCF/AHA 2011 and meet their
             recommendations for invasive therapies

          -  Referred or under active consideration within the past 12 months for SRT procedure and
             willing to have SRT procedure

          -  Has documented left ventricular ejection fraction (LVEF) ≥ 60% at Screening

          -  Has documented oxygen saturation at rest ≥ 90% at Screening

        Key Exclusion Criteria:

          -  Persistent or permanent atrial fibrillation and subject not on anticoagulation for ≥ 4
             weeks prior to screening and/or not adequately rate controlled ≤ 6 months prior to
             screening

          -  Previously treated with invasive septal reduction (surgical myectomy or percutaneous
             alcohol septal ablation [ASA])

          -  For individuals on beta blockers, calcium channel blockers, or disopyramide, any dose
             adjustment of these medications < 14 days prior to screening or an anticipated change
             in regimen during the first 16 weeks of the study

          -  Any medical condition that precludes upright exercise stress testing

          -  Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at
             screening

          -  Prior treatment with cardiotoxic agents, such as doxorubicin or similar

          -  Has a history or evidence of any other clinically significant disorder, condition, or
             disease that would pose a risk to subject safety or interfere with the study
             evaluation, procedures, or completion
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
Condition: Cholera
MeSH terms: Cholera
Intervention: PXVX0200; placebo
Intervention description: Single dose; liquid suspension after reconstitution with buffer; 5x10^8
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine if PXVX0200 is safe and effective in preventing
      cholera infection
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy men or women,

          -  age 18 to 45 years inclusive;

          -  normal medical history and physical examination; and

          -  no clinically significant abnormalities from:

          -  urine dipstick for glucose, protein, and blood

          -  complete blood count,

          -  serum hepatic transaminases,

          -  total bilirubin (direct if abnormal),

          -  creatinine,

          -  electrolytes,

          -  albumin, or

          -  electrocardiogram.

          -  Women must have a negative pregnancy test.

        Exclusion Criteria:

          -  travel to a cholera endemic area in the previous 5 years;

          -  abnormal stool pattern or regular use of laxatives;

          -  history of eating disorders (such as bulimia), anal or rectal disorders, allergy to
             tetracycline and/or ciprofloxacin;

          -  history of cholera or enterotoxigenic E. coli challenge or infection;

          -  current or recent antibiotic use;

          -  pregnancy or nursing;

          -  positive serology for HIV, hepatitis B antigen, or hepatitis C;

          -  any immunosuppressive medical condition;

          -  history of hospitalization for psychiatric illness or use of specific psychiatric
             drugs.
Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
Condition: Familial Hypercholesterolemia - Homozygous
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: lomitapide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous
      Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Japanese male and female patients aged ≥ 18 years of age who are receiving maximally
             tolerated, stable, lipid-lowering therapy

          2. Diagnosis of functional HoFH

          3. Body weight ≥ 40 kg and < 136 kg

          4. Negative pregnancy test at screening

        Exclusion Criteria:

          1. Uncontrolled hypertension

          2. History of chronic renal insufficiency

          3. History of biopsy proven cirrhosis or abnormal liver function tests (LFTs) at
             screening

          4. Any major surgical procedure occurring < 3 months prior to the screening visit

          5. Cardiac insufficiency

          6. Previous organ transplantation

          7. History of a non-skin malignancy within the previous 3 years

          8. Patients who are not able to limit their alcohol intake

          9. Participation in an investigational drug study within 6 weeks prior to the screening
             visit

         10. Known significant gastrointestinal bowel disease

         11. Nursing mothers

         12. Serious or unstable medical or psychological conditions

         13. Requirement for certain prohibited medications known to be potentially hepatotoxic

         14. Use of strong or moderate inhibitors of CYP3A4

         15. Use of simvastatin at doses >10 mg per day

         16. Documented diagnosis of any liver disease
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study
Condition: Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: DE-117 Ophthalmic Solution; Timolol Maleate Ophthalmic Solution 0.5%
Intervention description: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only; Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
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: 12 Months
Healthy volunteers: No

Summary:

      This is a Phase III, randomized, double-masked, active-controlled, parallel-group,
      multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at
      Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any.
      After completing the required washout period, subjects will return for Visit 2 (Baseline, Day
      1). Subjects who meet all eligibility criteria at baseline will be randomized to receive
      double-masked treatment for 3 months. Adult subjects will receive open-label DE-117
      Ophthalmic Solution for an additional 9 months.

      Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who
      meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

        -  DE-117 Ophthalmic Solution once daily and Vehicle once daily, or

        -  Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the
           efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate
           Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will
           provide additional safety data through Month 12 for subjects receiving DE-117.
    

Eligibility criteria:

        Inclusion Criteria:

        • glaucoma or ocular hypertension

        Exclusion Criteria:

          -  Females who are pregnant, nursing, or planning a pregnancy

          -  Any corneal abnormality or other condition interfering with or preventing reliable
             tonometric measurements
Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae
Condition: Spinal Fusion
Intervention: Pregabalin; placebo
Intervention description: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.; placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spinal fusion; pregabalin; Spinal fusion surgeries; two or more vertebrae

Summary:

      To see if the administration of 3 dosses of pregabalin (1 dose preoperative, 2 doses
      postoperative) will reduce the postoperative opiate requirements of patients undergoing
      spinal fusion surgeries of two or more vertebrae.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age : > 18 years old

          -  Fusion of > two vertebrae

          -  Capacity to provide consent

          -  ASA I-IV

          -  Ability to swallow capsules

        Exclusion Criteria:

          -  Plan of care includes intubated ICU admission post-op

          -  Allergy to gabapentin or pregabalin

          -  Two week prior use of pregabalin

          -  Significant renal dysfunction (creatinine level >2)

          -  Severe cardiovascular disease

          -  History of frequent headaches or dizziness

          -  Significant hepatic dysfunction (LFT's > 4 times the normal ranges)

          -  Active usage of alcohol or illicit substances three days prior to surgery

          -  History of seizure disorders

          -  Taking medication for anxiety, antiseizure, and psychiatric diagnoses

          -  Re-operation patients
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders; Hemorrhage
Intervention: nonacog beta pegol
Intervention description: For intravenous (i.v.) injection. A single dose of 40 U/kg, unless the bleeding episode is severe in which case it should be treated with 80 U/kg.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Male
Minimum age: 0 Years
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate the safety and
      efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. Trial-related
             activities are any procedures that are carried out as part of the trial, including
             activities to determine suitability for the trial

          -  Male, age below 6 years at the time of signing informed consent

          -  Patients with the diagnosis of haemophilia B (FIX (coagulation factor IX) activity
             level below or equal to 2%) based on medical records or central laboratory results

          -  Previously untreated or exposed to FIX containing products less than or equal to 3
             exposure days (5 previous exposures to blood components is acceptable)

        Exclusion Criteria:

          -  Any history of FIX inhibitors (defined by medical records)

          -  Known or suspected hypersensitivity to trial product or related products

          -  Previous participation in this trial. Participation is defined as first dose
             administered of trial product

          -  Receipt of any investigational medicinal product within 30 days before screening

          -  Congenital or acquired coagulation disorder other than haemophilia B

          -  Any chronic disorder or severe disease which, in the opinion of the Investigator,
             might jeopardise the patient's safety or compliance with the protocol

          -  Patient's parent(s)/LAR(s) (legally acceptable representative) mental incapacity,
             unwillingness to cooperate, or a language barrier precluding adequate understanding
             and cooperation
Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Etoricoxib 90 mg; Etoricoxib 120 mg; Ibuprofen 600 mg; Matching Placebo for Etoricoxib 120 mg; Matching Placebo for Etoricoxib 90 mg; Matching Placebo for Ibuprofen; Morphine; Oxycodone
Intervention description: One 90 mg tablet once daily; Two 60 mg tablets once daily; One tablet three times daily; Two tablets once daily; One tablet once daily; One tablet three times daily; As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection; 5 mg as needed
Intervention MeSH terms: Ibuprofen; Etoricoxib; Morphine; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 776.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to
      placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total
      knee replacement surgery. The hypotheses for this study were that the average pain intensity
      difference (at rest) in participants treated with Etoricoxib (120 mg, 90 mg) is superior to
      placebo, the average total daily dose of morphine in participants treated with Etoricoxib
      (120 mg, 90 mg) is less than in participants treated with placebo, and that Etoricoxib (120
      mg, 90 mg) will be generally safe and well tolerated by participants treated for pain
      following total knee replacement orthopedic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        - Is in generally good health and is scheduled to have a total knee replacement

        Exclusion Criteria:

          -  Is allergic, intolerant to, or has a history of a significant clinical or laboratory
             adverse experience associated with etoricoxib or other cyclooxygenase-2 (COX-2)
             inhibitors/non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen, morphine, or
             oxycodone, or has hypersensitivity to aspirin, or other NSAIDs

          -  Has uncontrolled hypertension

          -  Is currently a user of any illicit drugs, or has a history of drug or alcohol abuse
             within the past 5 years
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Condition: Relapsed/Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Plitidepsin; Dexamethasone
Intervention description: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.; 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Aplidin; plitidepsin; dexamethasone

Summary:

      Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients
      with relapsed/refractory multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2

          -  Life expectancy ≥ 3 months.

          -  Patients previously diagnosed with multiple myeloma

          -  Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at
             least three but not more than six prior therapeutic regimens for MM, including
             induction therapy and stem cell transplant in candidate patients, which will be
             considered as only one regimen.

          -  Patients must have received previous bortezomib-containing and lenalidomide-containing
             regimens (or thalidomide where lenalidomide is not available)

          -  Women must have a negative serum pregnancy test

          -  Voluntarily signed and dated written informed consent

        Exclusion Criteria:

          -  Concomitant diseases/conditions

          -  Women who are pregnant or breast feeding.

          -  Concomitant medications that include corticosteroids, chemotherapy, or other therapy
             that is or may be active against MM

          -  Known hypersensitivity to any involved study drug or any of its formulation components
A Study of S6G5T-3 in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: S6G5T-3; S6G5T-8
Intervention description: Once a day topical cream; Once a day topical cream
Intervention MeSH terms: Tretinoin; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 424.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: Acne Vulgaris

Summary:

      To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12
      weeks in participants with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant must sign an Institutional Review Board (IRB) approved written informed
             consent for this study.

          2. Male and female 9 years of age and older.

          3. Have 2 or fewer cysts or nodules.

        Exclusion Criteria:

          1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or
             equal to 5 millimeter (mm) in diameter).

          2. Acne conglobata, acne fulminans, and secondary acne (for example, chloracne,
             drug-induced acne).

          3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia,
             multiple myeloma).

          4. Underlying disease that requires the use of interfering topical or systemic therapy.

          5. Other dermatological conditions that require the use of interfering topical or
             systemic therapy or that might interfere with study assessments such as, but not
             limited to, atopic dermatitis, perioral dermatitis, or rosacea.