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 of Semagacestat for Alzheimer's Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: semagacestat
Intervention description: 140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability
Intervention MeSH terms: N2-((2S)-2-(3,5-difluorophenyl)-2-hydroxyethanoyl)-N1-((7S)-5-methyl-6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-L-alaninamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The primary objective of the original study was to assess the safety of semagacestat in
      Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the
      efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC
      (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0
      of this study (LFBF).

      Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression
      and was associated with worsening of clinical measures of cognition and the ability to
      perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC
      and LFBF have been amended to continue collecting safety data, including cognitive scores,
      for at least seven months. The CT-Registry will reflect results of analyses from the original
      protocol in addition to those from the amended protocol. Very few participants from LFBC
      rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC
      participants who rolled into LFBF were not analyzed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets National Institute of Neurological and Communicative Disorders and
             Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
             for probable Alzheimer's Disease

          -  Completed semagacestat study LFAN or study LFBC through 88 weeks

          -  Must continue to have a reliable caregiver

          -  Capable of swallowing whole oral medication

          -  Agrees not to participate in other investigational compounds for the duration of study

        Exclusion Criteria:

          -  Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or
             LFBC study
A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
Condition: Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Bococizumab (PF-04950615;RN316); Placebo
Intervention description: 150 mg every 2 weeks, subcutaneous injection, 12 months; subcutaneous injection every 2 weeks for 12 months
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 370.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: High Risk of cardiovascular events; Heterozygous familial hypercholesterolemia

Summary:

      This is a multicenter, randomized study in subjects with heterozygous familial
      hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and
      tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated with a statin.

          -  Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.

          -  High or very high risk of incurring a cardiovascular event.

          -  Heterozygous familial hypercholesterolemia.

        Exclusion Criteria:

          -  Pregnant or breastfeeding females.

          -  Cardiovascular or cerebrovascular event of procedures during the past 30 days.

          -  Congestive heart failure NYHA class IV.

          -  Poorly controlled hypertension.
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: 700 µg Dexamethasone; 350 µg Dexamethasone; Sham Injection
Intervention description: 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.; 350 µg Dexamethasone intravitreal implant administered on Day 0.; Sham injection on Day 0.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 668.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone
      for the treatment of macular edema associated with retinal vein occlusion.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 years of age or older with macular edema resulting from retinal vein occlusion

          -  Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or
             worse)

          -  Visual acuity in other eye no worse than 20/200

        Key Exclusion Criteria:

          -  Known anticipated need for ocular surgery within next 12 months

          -  History of glaucoma or current high eye pressure requiring more than 1 medication

          -  Diabetic retinopathy

          -  Uncontrolled systemic disease

          -  Known steroid-responder

          -  Use of systemic steroids

          -  Use of warfarin/heparin
Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine (Lu AA21004)
Intervention description: 2.5, 5, or 10 mg/day; tablets; orally
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 535.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Long-term; Safety; Open-label

Summary:

      The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine
      over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed
      8-week acute treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients who completed 8-week short-term treatment study for Major Depressive Episode,
        NCT00635219 / 11984A

        Exclusion Criteria:

          -  Any current psychiatric disorder other than MDD as defined in the Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR)

          -  Female patients of childbearing potential who are not using effective contraception

          -  Use of any psychoactive medication

        Other protocol-defined inclusion and exclusion criteria may apply.
PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
Condition: Anemia; Renal Diseases
MeSH terms: Anemia
Intervention: epoetin alfa; epoetin alfa; epoetin alfa
Intervention description: Continue pre-study once weekly dose of epoetin alfa for 36 weeks; Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks; Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 430.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anemia; Reduction in the number of erythrocytes; Hemoglobin low level; Red blood cell deficiency; Procrit; Epoetin alfa; Chronic kidney disease

Summary:

      The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks
      treatment with epoetin alfa, a drug that increases red blood cell production, in patients
      with anemia associated with chronic kidney disease, is not less effective than treatment with
      epoetin alfa that is given once a week
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular
             filtration rate (GFR) >=15 mL/min per 1.73 m2 and <60 mL/min per 1.73 m2 (Stages 3 and
             4) as calculated by the central laboratory

          -  Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization

          -  History of increase in hemoglobin after the initial dose

          -  Stable dose of epoetin alfa given once-weekly before randomization.

        Exclusion Criteria:

          -  Uncontrolled hypertension

          -  Iron deficiency

          -  iron overload

          -  severe congestive heart failure

          -  Active infection

          -  Recent heart attack, Stroke or blood clot.
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Condition: Inflammation; Pain; Cataract
MeSH terms: Cataract; Inflammation
Intervention: Loteprednol Etabonate Gel (BID); Vehicle Gel (BID)
Intervention description: One drop of LE gel instilled into the study eye two times per day (BID) for 14 days; One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate
      (LE) ophthalmic gel, 0.38% (BID)
    

Eligibility criteria:

        Inclusion Criteria:

        Visit 1 (Screening Visit)

          -  Be willing and able to comply with all treatment and follow-up/study procedures.

          -  Be a candidate for routine, uncomplicated cataract surgery.

        Visit 3 (Postoperative Day 1)

          -  Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with
             posterior chamber intraocular lens (IOL) implantation, not combined with any other
             surgery) in the study eye.

          -  Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

        Exclusion Criteria:

          -  Have a severe/serious ocular condition or history/presence of chronic generalized
             systemic disease that the Investigator feels might increase the risk to the subject or
             confound the result(s) of the study.

          -  Have known hypersensitivity or contraindication to the study drug(s) or their
             components.
Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathies; Pain
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: DVS SR; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 408.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuropathic pain; diabetic peripheral neuropathy

Summary:

      The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment
      of neuropathic pain associated with diabetic peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes type 1 or 2

          -  Painful symptoms of diabetic neuropathy in the lower extremities extremities for at
             least 6 months

        Exclusion Criteria:

          -  Major Depression

          -  Uncontrolled diabetes
COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Carvedilol Phosphate modified release formulation; metoprolol succinate
Intervention MeSH terms: Metoprolol; Carvedilol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension

Summary:

      This study was designed to determine whether treatment with COREG MR is more effective at
      maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of hypertension

          -  Triglycerides of 120-400 mg/mL

          -  LDLc levels not requiring lipid lowering medication.

        Exclusion Criteria:

          -  Has known contraindication to alpha- or beta-blocker therapy.

          -  Has taken any non-ocular beta-blockers within three months before screening.

          -  Has Type I or II diabetes.

          -  Taking lipid lowering medications.
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Condition: Atrial Fibrillation; Stroke
MeSH terms: Atrial Fibrillation
Intervention: WATCHMAN Device; Warfarin
Intervention description: WATCHMAN Left Atrial Appendage Closure Technology; Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
Intervention MeSH terms: Warfarin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; stroke; TIA; trans ischemic attack; warfarin; Coumadin

Summary:

      This was a prospective, randomized, multicenter study to provide additional information on
      the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL
      study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study
      and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in
      subjects with non-valvular atrial fibrillation who require anticoagulation therapy for
      potential thrombus formation.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Paroxysmal, persistent or permanent non-valvular AF

          -  Eligible for long-term warfarin therapy

          -  Eligible to come off warfarin therapy

          -  Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be
             included if any of the following apply:

               -  Female age 75 or older

               -  Baseline LVEF ≥ 30 and < 35%

               -  Aged 65-74 and has diabetes or coronary artery disease

               -  Aged 65 or greater and has congestive heart failure

        Key Exclusion Criteria:

          -  Contraindicated/allergic to aspirin

          -  Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to
             enrollment

          -  History of atrial septal repair or has an ASD/PFO device

          -  Implanted mechanical valve prosthesis

          -  NYHA Class IV CHF

          -  Resting heart rate > 110 bpm

          -  Participated previously in the PROTECT AF or CAP Registry studies

        Key Echo Exclusion Criteria:

          -  LVEF < 30%

          -  Existing pericardial effusion > 2mm

          -  High risk PFO

          -  Significant mitral valve stenosis

          -  Complex atheroma with mobile plaque of the descending aorta and/or aortic arch

          -  Cardiac tumor
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
Condition: Pneumococcal Disease; 13-valent Pneumococcal Vaccine
MeSH terms: Pneumococcal Infections
Intervention: 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine
Intervention description: 4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose); 3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose); 2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose); 2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart ); 1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 373.0
Sex: All
Minimum age: 42 Days
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 13 valent Pneumococcal Conjugate Vaccine; Antibody Response; safety; Alaskan Native Children

Summary:

      This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal
      conjugate vaccine in Alaskan Native Children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants 6 weeks to < 5years of age in good health, available for the
             entire study period and reachable by phone, parents able to complete all relevant
             study procedures.

          -  Infants who have received Prevnar are eligible to participate, but this is not
             required.

          -  Infants participating in the blood draws must live in a specific identified area
             (Yukon Kuskokwim Delta region)

        Exclusion Criteria:

          -  Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any
             vaccines or vaccine related components, immune deficiency, bleeding disorder or major
             known congenital malformation.