bioihbjkbjnl/mcl2 huggingface dataset:
Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)
Condition: Cardiovascular Disease; Diabetes Mellitus, Type 2
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9901.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Cardiovascular disease; Diabetes Mellitus; Dulaglutide

Summary:

      The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular
      events and other serious outcomes in persons with type 2 diabetes, when added to their
      anti-hyperglycemic regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than
             81 mmol/mol)

          -  Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or
             without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone

          -  On stable antihyperglycemic regimen for at least 3 months

          -  Age equal to or greater than 50 years with established clinical vascular disease, or
             age equal to or greater than 55 years and subclinical vascular disease or age equal to
             or greater than 60 years and at least 2 or more cardiovascular risk factors

        Exclusion Criteria:

          -  Uncontrolled diabetes requiring immediate therapy

          -  History of severe hypoglycemia in past year

          -  Acute coronary or cerebrovascular event within past 2 months

          -  Planned or anticipated revascularization procedure

          -  History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell
             thyroid disorder

          -  Pregnancy or planned pregnancy during the trial period

          -  Completed or withdrawn from any study investigating dulaglutide
Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: OPC-61815; Tolvaptan Tab 15 MG
Intervention description: Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg; Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 294.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using
      as the primary endpoint the change in body weight following 5-day intravenous administration
      of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF
      patients with volume overload despite having received diuretics other than vasopressin
      antagonists
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are currently on treatment with any of the following diuretics

               1. Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40
                  mg/day or higher

               2. Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide
                  analogs) at any dose

               3. Concomitant use of a loop diuretic and an aldosterone antagonist or
                  potassium-sparing diuretic agent at any dose

          -  Patients with congestive heart failure in whom lower limb edema, pulmonary congestion,
             and/or jugular venous distension due to volume overload is present

          -  Patients who are currently hospitalized or who are able to be hospitalized during the
             trial

        Exclusion Criteria:

          -  Patients with acute heart failure

          -  Patients who are on a ventricular assist device

          -  Patients who are unable to sense thirst or who have difficulty with fluid intake
Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy
Condition: Transthyretin (TTR) Amyloid Cardiomyopathy
MeSH terms: Cardiomyopathies
Intervention: Tafamidis; Tafamidis; Placebo
Intervention description: Tafamidis 20 mg in soft gel capsules administered once a day for 30 months; Tafamidis 80 mg in soft gel capsules administered once a day for 30 months; Placebo in soft gel capsules administered once a day for 30 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 441.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: amyloidosis; amyloid; transthyretin; TTR

Summary:

      This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily
      dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with
      either transthyretin genetic variants or wild-type transthyretin resulting in amyloid
      cardiomyopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or
             clinical evidence of HF (without hospitalization) manifested by signs or symptoms of
             volume overload or elevated intracardiac pressures (e.g., elevated jugular venous
             pressure, shortness of breath or signs of pulmonary congestion on x-ray or
             auscultation, peripheral edema) that required/requires treatment with a diuretic for
             improvement,

          -  Evidence of cardiac involvement by echocardiography with an end-diastolic
             interventricular septal wall thickness > 12 mm,

          -  Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotype
             and/or TTR precursor protein identification by immunohistochemistry, scintigraphy or
             mass spectrometry

        Exclusion Criteria:

          -  A New York Heart Association (NYHA) classification of IV.

          -  Presence of primary (light chain) amyloidosis.

          -  Prior liver or heart transplantation or implanted cardiac mechanical assist device.
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Condition: Lung Biopsy
MeSH terms: Pneumothorax
Intervention: ABPI; BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
Intervention description: If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.; If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 454.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Experimental: autologous blood patch injection (ABPI); Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug; 14-141

Summary:

      The purpose of this study is to compare two methods that are currently used at the end of a
      CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the
      chance of air leaking out of the hole. The two techniques consist of either injecting a very
      small amount of your the blood called a blood patch into the biopsy hole or injecting a
      gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed
      into the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years of age

          -  Referred for CT guided biopsy of lung lesion

          -  Target lesion of any size

          -  Target lesion located 1.5 cm or more away from visceral pleura based on the needle
             path

          -  Skin thickness ≤7 cm (from skin to pleura)

          -  Needle path without transgression of pleural fissure bleb, or bulla is possible

          -  Coaxial biopsy technique using Angiotech 19-Gauge introducer needle

          -  Needle length ≤15

        Exclusion Criteria:

          -  Passage through non-aerated lung or tissue

          -  More than 1 biopsy on the same side requiring more than 1 pleural puncture

          -  History of prior ipsilateral lung interventions including:

          -  Chest tube placement

          -  Surgery

          -  Pleurodesis

          -  Radiation treatment
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: bococizumab (PF-04950615); Placebo
Intervention description: 150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.; Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10564.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: myocardial infarction; stroke; hyperlipidemia

Summary:

      This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to
      placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular
      death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization
      in high risk subjects who are receiving background lipid lowering therapy and have
      cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL
      (3.4 mmol/L).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be on background lipid lowering treatment.

          -  Must be at high risk of a CV event.

          -  Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).

        Exclusion Criteria:

          -  Planned coronary (PCI or CABG) or other arterial revascularization.

          -  New York Heart Association Class IV congestive heart failure or left ventricular
             ejection fraction < 25% by cardiac imaging.

          -  Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD
             formula or with end state renal disease on dialysis.

          -  History of hemorrhagic stroke.

          -  Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
Condition: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypertriglyceridemia
Intervention: Epanova® (omega-3 carboxylic acids); corn oil control
Intervention description: Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE); corn oil control arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 13078.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: omega-3 carboxylic acid

Summary:

      The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design
      that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high
      risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once
      daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women, ≥18 years of age.

          2. Patient must be on a stable diet and statin* therapy at least 4 weeks prior to
             randomization (Visit 2) and meet the following criteria:

               1. LDL-C <100 mg/dL

               2. TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for
                  women

          3. Patient is at high risk for a future cardiovascular event if at least one of the
             following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or
             medical records at the time of screening:

               1. Any atherosclerotic CVD as defined in protocol.

               2. History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50
                  years of age for women, plus one of the risk factors defined in protocol.

               3. Male patients >50 years of age or females >60 years of age, with at least one of
                  the risk factors defined in protocol.

        Key Exclusion Criteria:

        1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid
        ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its
        analogues (>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.
Combined Medication for Improved Analgesia in Superficial Pain
Condition: Pain
Intervention: Diclofenac and Atropine combination drug; Placebo
Intervention description: Diclofenac will be associated with a small dose of atropine 1.2mg; For each capsule of active medication, a capsule of placebo will be provided, identical looking.
Intervention MeSH terms: Diclofenac; Atropine; Analgesics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This research study is being done to assess if a combination of medications can enhance the
      relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The
      investigators also want to find out if certain genes may be linked to individual differences
      in experienced efficacy of pain killers. The combination of medications under investigation
      is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug
      Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain
      types of poisoning, heartbeat problems, and other diseases but atropine is not approved to
      treat pain. However, atropine has been used for many years in different European countries to
      treat painful conditions such as stomach cramps.This research study will compare diclofenac
      and atropine to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female healthy volunteers.

          -  18-40 years of age.

          -  Ability to read and understand English; English can be a second language provided that
             the participant feels that he/she understand all the questions used in the assessment
             measures.

        Exclusion Criteria:

          -  Chronic pain condition or chronic or current treatment with any pain medication.

          -  Presence of any illness or medication use that is judged to interfere with the trial.
             For example: psychiatric disorder, medication that can influence cognition or
             emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or
             opioids.

          -  Unwillingness to receive brief pain stimulation administered by a heat probe on the
             hand.

          -  Allergy or contra-indication to receiving nonsteroidal anti-inflammatory medication
             and atropine (Treatment with antidepressants, neuroleptics, antihistaminic, levodopa,
             anti-acids. Pregnancy, breast-feeding, myasthenia gravis, pyloric stenosis,
             gastro-esophageal reflux, gastric ulcer, constipation, prostatic enlargement,
             glaucoma, cardio-pulmonary condition -including tachycardia, arrhythmia,
             arteriosclerosis-, hyperthyroidism, high blood pressure, genetic disease, kidney
             failure)
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
Condition: Glaucoma; Angle-Closure
MeSH terms: Glaucoma; Glaucoma, Angle-Closure
Intervention: XEN45
Intervention description: XEN45 unilaterally implanted in the study eye
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with
      Angle Closure Glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria: - Diagnosis of ACG defined as areas of iridotrabecular contact present
        in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye -
        Study eye has healthy, free, and mobile conjunctiva in the target quadrant Exclusion
        Criteria: - Uncontrolled systemic disease (eg, diabetes, hypertension) - Known history of
        bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood
        thinners other than aspirin (up to 100 mg/day) - History of dermatologic keloid formation -
        Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile
        glaucoma, secondary glaucoma in the study eye - History of following surgeries in the study
        eye: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic
        keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as
        Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial
        keratoplasty o previous laser or incisional intraocular surgery that might interfere with
        the outcome of this trial - Previous glaucoma shunt implantation in the target quadrant in
        the study eye - Active or history of chronic uveitis in the study eye - Unable to
        discontinue contact lens wear in the study eye during the study
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: SEL; Placebo to match SEL 6 mg; Placebo to match SEL 18 mg
Intervention description: Tablets administered orally once daily; Tablets administered orally once daily; Tablets administered orally once daily
Intervention MeSH terms: Selonsertib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 808.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can
      cause fibrosis regression and reduce progression to cirrhosis and associated complications in
      adults with NASH and bridging (F3) fibrosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH
             Clinical Research Network (CRN) classification in the opinion of the central reader

          -  Has the following laboratory parameters at the screening visit:

               -  Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)

               -  Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the
                  Cockcroft-Gault equation

               -  Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is
                  unable to be resulted)

               -  Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's
                  syndrome or hemolytic anemia is present)

        Key Exclusion Criteria:

          -  Prior history of decompensated liver disease including clinical ascites, hepatic
             encephalopathy (HE), or variceal bleeding

          -  Child-Pugh (CP) score > 6, as determined at screening, unless due to therapeutic
             anti-coagulation

          -  Model for End-stage Liver Disease (MELD) score > 12, as determined at screening,
             unless due to therapeutic anti-coagulation

          -  Other causes of liver disease including, but not limited to, alcoholic liver disease,
             hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson
             disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history
             and/ or centralized review of liver histology.

          -  History of liver transplantation

          -  Current or history of hepatocellular carcinoma (HCC)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.