bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: dronedarone (SR33589); amiodarone
Intervention description: oral administration; oral administration
Intervention MeSH terms: Amiodarone; Dronedarone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 504.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; sinus rhythm; amiodarone

Summary:

      The objective of this study is to compare the efficacy and safety of dronedarone to that of
      amiodarone for the treatment of patients with atrial fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with documented atrial fibrillation for more than 72 hours for whom
             cardioversion and antiarrhythmic treatment is indicated in the opinion of the
             investigator and under oral anticoagulation

        Exclusion Criteria:

          -  Contraindication to oral anticoagulation

          -  Patient having received amiodarone in the past whatever the date (more than a total of
             twenty 200 mg tablets or more than 5 days intravenous)

          -  Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial
             fibrillation

          -  Severe congestive heart failure with New-York Heart Association (NYHA) class III or
             IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially
             dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks,
             stroke, syncope, as judged by the investigator, first degree family history of sudden
             cardiac death below age 50 years in the absence of coronary heart disease, significant
             sinus node disease without a permanent pacemaker implanted

          -  History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecs
             before randomization

          -  Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued

          -  Dysthyroidism or other contraindication to amiodarone

        The above information are not intended to contain all the considerations relevant to a
        patient's potential participation in a clinical trial.
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost SR; Active Comparator: Timolol 0.5%; Sham: Applicator Without Needle; Timolol Vehicle (placebo)
Intervention description: Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.; Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.; Sham administered on Day 1, Week 16, and Week 32.; Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Intervention MeSH terms: Timolol; Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 594.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of bimatoprost SR in participants with
      open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period
      with an 8-month extended follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

        -Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes
        require IOP-lowering treatment.

        Exclusion Criteria:

          -  Previous enrollment in another Allergan Bimatoprost SR Study.

          -  Eye surgery (including cataract surgery) and/or any eye laser surgery within the past
             6 months in the study eye

          -  Anticipated need for laser eye surgery in either eye within the first 52 weeks of the
             study duration

          -  History of glaucoma surgery
Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237; Tiotropium
Intervention description: 50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®); 18µg capsules for inhalation, delivered via HandiHaler®
Intervention MeSH terms: Glycopyrrolate; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; NVA237

Summary:

      This is a 52-week, multi-center, randomized, open label, parallel group study to assess the
      long term safety and tolerability of once-daily NVA237, using tiotropium as an active
      control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease
      (COPD) .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate to severe stable COPD (Stage II or Stage III) according to the
             Gold Guideline 2008.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years.

          -  Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and
             postbronchodilator FEV1/FVC < 0.7 at Visit 2 (day -7)

        Exclusion Criteria:

          -  Pregnant women or nursing mothers or women of child-bearing potential not using an
             acceptable method of contraception

          -  Patients requiring long term oxygen therapy

          -  Patients who have had a lower respiratory tract infection within 6 weeks prior to
             Visit 1

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular comorbid conditions

          -  Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

          -  Patients in the active phase of a supervised pulmonary rehabilitation program

          -  Patients contraindicated for tiotropium or ipratropium treatment or who have shown an
             untoward reaction to inhaled anticholinergic agents

          -  Other protocol-defined inclusion/exclusion criteria may apply
Prospective Biomarkers of Bone Metabolism in Hemophilia A
Condition: Hemophilia; Bone Disease
MeSH terms: Bone Diseases; Hemophilia A
Intervention: Advate
Intervention description: Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 16 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: hemophilia; bone disease; clinical study; biomarkers

Summary:

      One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture
      outcome data demonstrating the clinical significance of decreased BMD and altered bone
      biomarkers in the hemophilia population. This study demonstrates that PwH have an increased
      risk of fracture compared to the general population and that the issue of bone health will
      increase in importance as the PwH population ages.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males with a diagnosis of hemophilia A with a historic baseline FVIII level ≤ 2%.

          2. Age > 16 years old

          3. Currently using ADVATE as FVIII replacement therapy

        Exclusion Criteria:

          1. Subject or guardian is unwilling or unable to give written informed consent and/or
             assent

          2. Joint or muscle bleeding within 2 weeks of Study Day 1

          3. Presence of a current factor inhibitor (>0.6 BU/mL via Nijmegan-modified Bethesda
             assay)

          4. Known collagen vascular bone disease.
Naturlose (D-Tagatose) Efficacy Evaluation Trial
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Tagatose; Sugar Substitute Splenda
Intervention description: powder; 15 grams three times daily; one year; 1.5 g powder tid
Intervention MeSH terms: Tagatose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 494.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this trial was to evaluate the effectiveness and safety of Naturlose
      (Tagatose) for glycemic control in people with Type 2 diabetes who were not taking other
      medications for the condition and who were under diet control and exercise.

      The study lasted approximately one year. HbA1c was monitored every 2 months after entry into
      the study. Safety and tolerance for tagatose were assessed every 2 months throughout the
      study. A total of 14 visits were made to the study site.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetics in accordance with WHO.

          -  Male and female patients, between 18 and 75 years of age.

          -  Diabetic patients who are not on medication for the disease. Patients may be treated
             with diet and exercise.

          -  Normal blood creatine clearance and normal liver function test results.

          -  BMI less than or equal to 45kg/m2.

        Exclusion Criteria:

          -  Treatment with sulfonylurea (e.g., Glyburide, Glipizide, Glimepiride, Chlorpropamide,
             Tolazamide, Acetohexamide, or Tolbutamide), TZDs, metformin, acarbose, Byetta,
             insulin, and any antidiabetic medications within the prior 3 months.

          -  Therapy with beta-blockers or thiazide diuretics within the prior 3 months.

          -  Pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using
             inadequate contraceptive measure.

          -  Documented gastrointestinal disease, or taking of medications likely to alter gut
             motility or absorption.

          -  Receiving any investigational drug within 30 days of the baseline visit.
The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: phenylephrine; pseudoephedrine; placebo
Intervention description: immediate-release 12 mg capsules for oral administration; 60 mg immediate-release tablets for oral administration; placebo capsules
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Pseudoephedrine; Ephedrine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover
      study, conducted at a single site in Austria, outside of the normal grass pollen season. An
      allergic reaction will be induced by exposing subjects to grass pollen in the Vienna
      Challenge Chamber (VCC). Subjects will receive a single dose of each of the following
      treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release
      capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a
      minimum of a 5-day washout period between each treatment. Subjects will complete symptom
      evaluations throughout the study. The nasal decongestant effects of phenylephrine will be
      compared to those of placebo using the subjective symptom evaluations. The safety profile
      (adverse events and vital signs) of the treatments will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Skin test positive for the grass pollen allergen used in the chamber at Screening or
             within the prior 12 months.

          -  A negative urine pregnancy test at Screening and at monthly intervals for female
             subjects of childbearing potential.

          -  The following minimum scores at an evaluation time point during each of the 120-minute
             screening period challenge sessions:

               1. Nasal Congestion Score of at least 2 (moderate);

               2. Total Nasal Symptoms Score of at least 6;

               3. Total Non-nasal Symptoms Score of at least 2.

          -  Freedom from any clinically significant disease, other than SAR, that would interfere
             with the study evaluations.

        Exclusion Criteria :

          -  An upper or lower respiratory tract infection within 4 weeks before Screening.

          -  Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or
             nasal steroids, in the opinion of the investigator.

          -  A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the
             study drug or excipients.
Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination tablet orally once daily in the morning.; IVA tablet orally once daily in the evening.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and
      pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple
      combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF
      genotypes.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex,
             and height.

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary
             status.

          -  Solid organ or hematological transplantation.

        Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
Condition: Contraception; Ovulation Inhibition; Contraceptives, Oral
Intervention: EE20/DRSP (BAY86-5300); EE20/DRSP (BAY86-5300); EE20/DRSP (YAZ, BAY86-5300)
Intervention description: Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone; Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone; Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)
Intervention MeSH terms: Drospirenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1887.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oral Contraception; Birth Control pill; Healthy women requesting oral contraception; Contraceptive efficacy

Summary:

      The purpose of this study is to determine whether the study drug is safe and effective.
    

Eligibility criteria:

        Inclusion Criteria:

        - Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35
        years of age.

        Exclusion Criteria:

        - The use of steroidal oral contraceptives, or any drug that could alter oral contraception
        metabolism will be prohibited during the study.
Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
Condition: 13-valent Pneumococcal Vaccine; Immunization; Safety; Antibody Response
Intervention: 13-valent pneumococcal conjugate vaccine
Intervention description: All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 263.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccine 13-valent

Summary:

      This is an open-label study (a study in which the doctors and participants know which drug or
      vaccine is being administered) in children who previously received a 4-dose series of a
      pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In
      this study, participants will receive an additional dose of 13-valent pneumococcal conjugate
      vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody
      response by measuring any remaining pneumococcal antibodies since the previous study. This
      study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate
      vaccine when administered at least 24 months after the last dose of pneumococcal conjugate
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects at least 3 years of age, who received all 4 assigned doses of
             pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at
             least 24 months

        Exclusion Criteria:

          -  Vaccination with any licensed or investigational pneumococcal vaccine since completion
             of Study 6096A1-008-EU(NCT00366678).

          -  History of culture-proven invasive disease caused by S pneumoniae since the completion
             of Study 6096A1-008-EU (NCT00366678).

          -  Previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Contraindication to vaccination
Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Intervention: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®"; 0.9 % NaCl
Intervention description: Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs.; NaCl 0.9 % was administered intravenously. NaCl 0.9% rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day, according to patient needs.
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The rapidity and the quality of fluid resuscitation in patients with severe sepsis are
      important factors for the prevention of secondary multi-organ failure. Vascular filling may
      also have an impact on tolerability of enteral nutrition. The earliness and quantity of
      calories provided by enteral nutrition may have an impact on morbidity and mortality. This
      study will asses the effects of volume expansion on hemodynamics and tolerability of enteral
      nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly
      safety data of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe sepsis

          -  Requirement for fluid resuscitation

        Exclusion Criteria:

          -  serum creatinine > 300µmol/L

          -  Chronic renal failure

          -  Anuria lasting more than 4 hours

          -  Requirement for renal support
A Severity-Adapted Clinical Trial of Diminished Bone Mineral Density in Acute Lymphoblastic Leukemia Survivors
Condition: Leukemia, Lymphoblastic, Acute; Osteoporosis
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Osteoporosis
Intervention: Calcium carbonate (Tums), vitamin D; Placebo
Intervention description: Calcium carbonate 100mg/day (Tums), vitamin D 800 units/day; Placebo
Intervention MeSH terms: Vitamin D; Calcium Carbonate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 429.0
Sex: All
Healthy volunteers: No
Keywords: Bone Density

Summary:

      Research studies have shown that children who are long-term survivors of childhood leukemia
      may be at greater risk for early bone loss called osteoporosis. This bone loss may lead to a
      greater risk of broken bones and other spine and bone problems. However, researchers still do
      not know much about how frequently this long-term side effect may occur and how severe the
      problem is.

      St. Jude Children's Research Hospital researchers want to determine the frequency and
      severity of this side effect. They are also studying whether taking calcium and Vitamin D
      supplements can help children at risk for osteoporosis and if certain factors can be
      identified -- such as age at diagnosis, cancer treatments, or family history -- that may
      increase the chances of having osteoporosis. Researchers will take an x-ray study called
      quantitative computed tomography (QCT) to measure bone mineral density (BMD). The BMD is a
      measure of bone strength. If a subject's BMD falls below the average, he/she will be assigned
      to one of two groups. Subjects will be randomly assigned (like tossing a coin) to receive
      calcium and vitamin D pills. The other half will receive placebo pills that look like the
      calcium and vitamin D pills.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is a survivor of acute lymphoblastic leukemia.

          -  Patient was treated on St. Jude Children's Research Hospital's Total XI, XII, or XIII
             treatment protocol.

          -  Patient is at least five years out from completion of therapy and is in first
             remission

        Exclusion Criteria:

          -  Active disease

          -  Pregnant or lactating females

          -  Inability to chew and swallow pills

          -  Currently taking more than 800 mg supplemental calcium or 800 IU vitamin D

          -  Anemia