bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
Condition: Cytokine Storm (Covid-19)
MeSH terms: COVID-19; Cytokine Release Syndrome
Intervention: Ruxolitinib; Placebo
Intervention description: Ruxolitinib 5 mg tablets; Matching-image placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 432.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: COVID-19 pneumonia; cytokine release syndrome; SARS-COV-2; ruxolitinib

Summary:

      This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess
      the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with
      placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Patient or guardian/health proxy must provide informed consent (and assent if applicable)
        before any study assessment is performed.

        Male and female patients aged ≥ 12 years (or ≥ the lower age limit allowed by Health
        Authority and/or Ethics Committee/Institutional Review Board approvals).

        Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction
        (PCR) test or another rapid test from the respiratory tract prior to randomization.

        Patients currently hospitalized or will be hospitalized prior to randomization.

        Patients, who meet at least one of the below criteria:

          -  Pulmonary infiltrates (chest X ray or chest CT scan);

          -  Respiratory frequency ≥ 30/min;

          -  Requiring supplemental oxygen;

          -  Oxygen saturation ≤ 94% on room air;

          -  Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg
             (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions
             (over 1000m).

        Exclusion Criteria:

        History of hypersensitivity to any drugs or metabolites of similar chemical classes as
        ruxolitinib.

        Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8
        μmol/L), or have estimated creatinine clearance < 30 ml/min measured or calculated by
        Cockroft Gault equation or calculated by the updated bedside Schwartz equation.

        Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).

        Currently intubated or intubated between screening and randomization. In intensive care
        unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to
        screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs
        (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).

        Unable to ingest tablets at randomization. Pregnant or nursing (lactating) women
A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: 80 mg ixekizumab Dosing Regimen; 50 mg etanercept; Placebo
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Etanercept; Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to
      etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque
             psoriasis for at least 6 months prior to first dose of study drug

          -  At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of
             study drug

          -  Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and
             Severity Index (PASI) score of at least 12 at screening and at first dose of study
             drug

          -  Candidate for phototherapy and/or systemic therapy

          -  Men must agree to use a reliable method of birth control or remain abstinent during
             the study

          -  Women must agree to use reliable birth control or remain abstinent during the study
             and for at least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  Pustular, erythrodermic, and/or guttate forms of psoriasis

          -  History of drug-induced psoriasis

          -  Prior use of etanercept

          -  Clinically significant flare of psoriasis during the 12 weeks prior to randomization

          -  Concurrent or recent use of any biologic agent

          -  Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens
             and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had
             topical psoriasis treatment within the previous 2 weeks prior to randomization

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to randomization and during the study

          -  Have participated in any study with interleukin 17 (IL-17) antagonists, including
             ixekizumab

          -  Serious disorder or illness other than plaque psoriasis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women
A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Albiglutide 30 mg weekly; Albiglutide 50 mg weekly; Placebo; Liraglutide 0.9 mg daily
Intervention description: Albiglutide will be available as a pen injector that delivers 30mg of albiglutide; Albiglutide will be available as a pen injector that delivers 50mg of albiglutide; Albiglutide matching placebo will be available as a pen injector; Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose
Intervention MeSH terms: Liraglutide; rGLP-1 protein; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 494.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: albiglutide; Japanese; GSK716155; Type 2 diabetes mellitus; glucagon-like peptide 1

Summary:

      This study is designed to examine the efficacy and safety of 2 dose levels of weekly
      subcutaneously injected albiglutide compared with placebo and an open label reference arm of
      daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or
             a stable dose of 1 OAD at screening

          -  Body mass index (BMI) 17 to 40 kg/ m^2 inclusive

          -  Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2;
             for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening
             and HbA1c between 7.0% and 10.0% at Visit 2

          -  Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or <6
             weeks postpartum•

          -  Clinically significant cardiovascular and/or cerebrovascular disease

          -  Current ongoing symptomatic biliary disease, clinical signs or symptoms of
             pancreatitis, or a history of chronic or acute pancreatitis, as determined by the
             investigator

          -  Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing
             any symptoms possibly related to pancreatitis

          -  Prior use of a TZD or GLP-1R agonist within 4 months before Screening
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
Condition: Heart Defects, Congenital
MeSH terms: Univentricular Heart; Heart Defects, Congenital; Congenital Abnormalities
Intervention: Blalock-Taussig pulmonary artery shunt; Right ventricular to pulmonary artery shunt
Intervention description: Performed at stage I palliative surgery for babies born with HLHS; Performed at stage I palliative surgery for babies born with HLHS
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 555.0
Sex: All
Healthy volunteers: No

Summary:

      This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS)
      compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of
      the MBTS to that of the RV-to-PA shunt on the incidence of death or cardiac transplantation
      at 12 months post randomization; and compare the effect of the two shunts on intensive care
      unit (ICU) morbidity, unintended cardiovascular interventional procedures, right ventricular
      function, tricuspid valve regurgitation, pulmonary artery growth, and neurodevelopmental
      outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of hypoplastic left heart syndrome or related single, morphologic right
             ventricle anomaly

          -  Planned Norwood procedure

          -  Informed consent of parent(s) or legal guardian

        Exclusion Criteria:

          -  Single, morphologic left ventricle anomaly

          -  Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt
             technically impossible

          -  Any major congenital abnormality (i.e., congenital diaphragmatic hernia,
             tracheoesophageal fistula) or acquired extra-cardiac disorder (e.g., meconium
             aspiration with need for high frequency ventilation, persistent renal failure
             requiring dialysis) that, in the opinion of the investigator, could independently
             affect the likelihood of the subject meeting the primary endpoint
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Istradefylline 40 mg; Istradefylline 20 mg; Placebo
Intervention description: Istradefylline 40 mg and placebo; Istradefylline 20 mg and placebo; Placebo
Intervention MeSH terms: Istradefylline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 613.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's disease; Moderate to Severe Parkinson's Disease

Summary:

      This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in
      patients with moderate to severe Parkinson's Disease. While on this study, participants will
      continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or
      Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be
      randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per
      day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate
      the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as
      improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in
      this group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  30 years of age or older.

          -  UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD

          -  PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.

          -  On levodopa therapy for at least 1 year with beneficial clinical response at the
             baseline visit

          -  Taking at least 400mg levodopa combination daily and on stable regimen of any other
             anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization

          -  Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization

          -  Documented end-of-dose wearing-off and levodopa-induced dyskinesia

          -  Have an average of two hours of OFF time per day

        Exclusion Criteria:

          -  Subjects on apomorphine and/or dopamine receptor antagonists or direct
             gastrointestinal levodopa infusion.

          -  Subject who have had neurosurgical operation for PD

          -  Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers

          -  Subjects who smoke > 5 cigarettes/day
Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)
Condition: Asthma
MeSH terms: Asthma
Intervention: Ciclesonide; Fluticasone
Intervention description: inhaled Ciclesonide 160 µg, once daily in the morning; inhaled Fluticasone 100 µg, twice daily
Intervention MeSH terms: Fluticasone; Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Asthma; AMP; Ciclesonide; Fluticasone propionate

Summary:

      The aim of this study is to compare the responsiveness of lower airways in adult patients
      with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment
      medication will be administered as follows: ciclesonide will be inhaled once daily at one
      dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study
      duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study
      will provide further data on safety and tolerability of ciclesonide.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  History of bronchial asthma

          -  FEV1 > 1.20 L

          -  Positive Skin Prick Test

          -  Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days
             prior to baseline visit

        Main Exclusion Criteria:

          -  Clinically relevant abnormal laboratory values

          -  Concomitant severe diseases, diseases expected to interfere with the outcome of the
             study and diseases which are contra-indications for the use of inhaled steroids

          -  Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases

          -  One asthma exacerbation within 2 months or more than 3 exacerbations within the last
             year prior to baseline visit

          -  Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1
             year prior to baseline visit

          -  Positive response to saline challenge at baseline visits

          -  Positive bronchial hyperresponsiveness
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Baricitinib; Placebo
Intervention description: Administered orally.; Administered orally.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Polyarticular JIA; Oligoarthritis; Juvenile psoriatic arthritis (JPsA); Enthesitis-related juvenile idiopathic arthritis (ERA)

Summary:

      The reason for this study is to see if the study drug baricitinib given orally is safe and
      effective in participants with JIA from 2 years to less than 18 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have had a diagnosis of active JIA (polyarticular, extended
             oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including
             JPsA).

          -  Participants must have had an inadequate response to at least one conventional or
             biologic disease-modifying antirheumatic drug (DMARD).

        Exclusion Criteria:

          -  Participants must not have systemic JIA, with or without active systemic features.

          -  Participants must not have persistent oligoarticular arthritis.

          -  Participants must not have been previously treated with a Janus kinase (JAK)
             inhibitor.
An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Moxifloxacin ophthalmic solution, 0.5%; Ofloxacin ophthalmic solution, 0.3%
Intervention MeSH terms: Moxifloxacin; Ofloxacin; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 985.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Bacterial conjunctivitis; Anti-infective; Antibiotics

Summary:

      The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the
      treatment of bacterial conjunctivitis in Chinese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese.

          -  Diagnosis of bacterial conjunctivitis based on clinical observation.

          -  Understand and sign the approved informed consent. Legally authorized representative
             can provide informed consent for patients less than 18 years old and/or incapable of
             understanding the informed consent.

          -  Willing to complete all required study procedures and visits.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Women who are pregnant, lactating, or planning a pregnancy.

          -  Only 1 sighted eye or vision not correctable to 0.6 logMAR or better in either eye.

          -  Planned contact lens wear during the course of the study.

          -  Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to
             Screening (Day 1).

          -  Suspected fungal, viral, or Acanthamoeba infection.

          -  Any systemic or ocular disease or disorder, complicating factor or structural
             abnormality that would negatively affect the conduct or outcome of the study.

          -  History of recent surgery.

          -  Presence of concomitant systemic viral infection.

          -  Other protocol-defined exclusion criteria may apply.
Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive
Intervention: indacaterol and glycopyrronium bromide (QVA149); placebo; tiotropium
Intervention MeSH terms: Glycopyrrolate; Bromides; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; QVA149; tiotropium; exercise; exercise tolerance; combination bronchodilator; moderate to severe COPD

Summary:

      This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149)
      on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary
      Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD)
             stage II or stage III according to the Global Initiative for Chronic Obstructive Lung
             Disease (GOLD) Guidelines (2009)

          -  Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and
             post-bronchodilator FEV1/FVC (Forced Vital capacity)

          -  Smoking history ≥ 10 pack years

        Exclusion Criteria:

          -  Pregnant women or nursing mothers or women of child-bearing potential not using
             adequate contraception

          -  Cardiac abnormality

          -  History of asthma

          -  Contraindications to cardiopulmonary exercise testing

          -  Participation in active phase of pulmonary rehabilitation program

          -  History of cancer within the past 5 years

        Other protocol-defined inclusion/exclusion criteria may apply