bioihbjkbjnl/mcl2 huggingface dataset:
Safety Tolerability and Efficacy Study of Cabaletta to Treat Oculopharyngeal Muscular Dystrophy (OPMD) Patients
Condition: Oculopharyngeal Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Oculopharyngeal
Intervention: Cabaletta
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Case control, safety, tolerability, efficacy.

Summary:

      The Purpose of this study is to assess the Safety, Tolerability and Efficacy of Intravenous
      Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females

          -  18 - 80 years (inclusive) of age

          -  Clinically and genetically diagnosed as OPMD

          -  Moderate dysphagia (abnormal drinking test at screening and on the first dosing day,
             before drug administration)

          -  Patients who provide written informed consent to participate in the study

          -  Body Mass Index (BMI) <30 kg/m2

        Exclusion Criteria:

          -  Diabetes mellitus type 1 or 2

          -  Other major diseases, e.g.: renal failure (creatinine clearance <60ml/min), liver
             failure and chronic liver diseases (e.g. hepatitis B or C) , HIV carriers,
             tuberculosis, SLE, rheumatoid polyarthritis, sarcoidosis, collagenosis

          -  Uncontrolled heart disease , CHF,

          -  Other neuromuscular diseases

          -  Other disorders associated with esophageal dysphagia: e.g. severe gastroesophageal
             reflux (GERD), esophageal stricture due to mechanical or chemical trauma, infection
             (e.g. esophageal moniliasis), drug-induced dysphagia (e.g. bisphosphonates),
             esophageal rings and webs, spastic motility disorders of the esophagus.

          -  History of malignancy (except non-invasive skin malignancy)

          -  History of neck irradiation

          -  Pregnant or currently lactating women

          -  Obesity (BMI≥ 30) and associated morbidity

          -  Prior pharyngeal myotomy

          -  Weight loss of more than 10% in the last 12 months.

          -  Known hypersensitivity to any ingredients in the injection

          -  Patient receiving anticoagulant treatment (e.g. warfarin)
Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: dasatinib; Placebo
Intervention description: GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.; Matching Placebo
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic cancer; Dasatinib; chemotherapy; Locally advanced

Summary:

      The purpose of this study is to determine whether patients with locally advanced pancreatic
      cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to
      patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic documentation of unresectable adenocarcinoma of the pancreas.

          -  Recovery from toxicity of previous procedures to establish the diagnosis. ECOG PS 0 or
             1.

          -  Adequate organ function.

        Exclusion Criteria:

          -  Evidence of metastatic disease.

          -  Previous radiotherapy or chemoradiotherapy.

          -  History of or current pleural effusion.

          -  History of significant cardiovascular disease.

          -  Clinically significant bleeding disorder or coagulopathy.

          -  Concomitant medication with strong CYP 3A4 inhibitor.
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: JTE-051; Placebo
Intervention description: Active drug tablets containing JTE-051; Placebo tablets identical in appearance to the active drug tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: JTE-051; Active Rheumatoid Arthritis; Efficacy; Safety; Tolerability; Rheumatoid Arthritis

Summary:

      This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of
      JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are
      receiving background non-biologic disease-modifying anti-rheumatic drug therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of RA prior to the Screening Visit.

          -  Active disease despite ongoing therapy with up to two non-biologic disease-modifying
             anti-rheumatic drugs, including methotrexate at both the Screening and Baseline
             Visits.

          -  Screening hs-CRP ≥1.2 x upper limit of normal (ULN).

        Exclusion Criteria:

          -  Prior/current exposure to biologic and/or kinase inhibitor therapy.

          -  Known history or presence of polyneuropathy of any cause and no presence of clinically
             active compression neuropathy, radiculopathy or plexopathy at the Screening Visit.

          -  Positive test results for human immunodeficiency (HIV) virus, hepatitis B virus or
             hepatitis C (HCV) virus at the Screening Visit.

          -  Positive drug of abuse and alcohol test results.

          -  History of a clinically-significant infection that required oral antimicrobial or
             antiviral therapy within 8 weeks prior to Day 1.
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: FTY720; Placebo
Intervention description: FTY720 capsule was taken orally once a day; Placebo 1.25 mg capsule was given once daily
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: FTY720; MS; Multiple Sclerosis; RRMS

Summary:

      This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720
      in patients with relapsing multiple sclerosis.
    

Eligibility criteria:

        Core Study

        Inclusion Criteria:

          -  Diagnosis of relapsing multiple Sclerosis (MS)

          -  Patients with at least two documented relapses in the previous 2 years or one
             documented relapse in the last year

          -  Patients with an Expanded Disability Status Scale (EDSS) score of 0-6

        Extension Study

          -  A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at
             screening was negative, a second scan could have been obtained 1 month later)

          -  Neurologically stable with no evidence of relapse within 30 days prior to
             randomization,or during the Screening and Baseline periods.

          -  Female patients either post-menopausal, surgically incapable of bearing children, or
             practicing an acceptable method of birth control. Females of childbearing potential
             with a negative pregnancy test at baseline prior to entry into the treatment period.

        Exclusion Criteria:

        Core Study

          -  Patients with other chronic disease of the immune system, malignancies, pulmonary or
             heart disease, etc

          -  Pregnant or nursing women

        Extension Study

          -  Patients who had permanently discontinued study drug prior to the Month 6 visit of the
             core study

          -  Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing
             patients with diabetes mellitus or who developed diabetes mellitus were discontinued
             from the study)

        Other protocol-defined inclusion/exclusion criteria may apply
Effects of CLA Supplements on Body Weight and Fat Oxidation
Condition: Obesity
MeSH terms: Body Weight
Intervention: conjugated linoleic acid
Intervention description: 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: No

Summary:

      Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural
      sources. When given to small animals, decreases of body fat have been noted.. Although weight
      loss is the best treatment for overweight and obesity, it is difficult to maintain the loss
      in the long term. Because of this, treatment emphasis has turned to small weight losses
      obtained through non-restrictive diets and prevention of weight regain. This is a study to
      determine if 6 months of consumption a purified form of CLA will result in greater loss of
      body fat than control and to determine whether CLA consumption increases total fat oxidation,
      which would help explain why the weight loss occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI 25-29.9 kg/m2

          -  Absence of a weight change of greater than 3 kg in the previous 6 months

        Exclusion Criteria:

          -  Presence of a physical limitation to walking exercise

          -  Current or recent (6 months) enrollment in a commercial or self-prescribed weight loss
             program

          -  A history of metabolic disease-ie. renal, endocrine, hepatic or gastrointestinal
             disease that would impact the outcome of the study

          -  A history of a psychiatric or eating disorders Ÿ Presence of metal implants that would
             interfere with body composition analysis

          -  Fasting plasma cholesterol >300mg/dl or triglycerides above 500 mg/dl.

          -  Abnormal EKG
Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; Atorvastatin; CP-690,550; Atorvastatin Placebo
Intervention description: 12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12; Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily; 12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12; Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily
Intervention MeSH terms: Atorvastatin; Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cholesterol; lipids; rheumatoid arthritis; CP-690; 550

Summary:

      All patients will be in instructed to eat a therapeutic lifestyle diet and will receive
      CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the
      cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first
      measure the effects of CP-690,550 on cholesterol levels and then the effects of adding
      atorvastatin on those levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must be diagnosed as having active rheumatoid arthritis

          -  agree to participate in the study and sign and informed consent document

        Exclusion Criteria:

          -  History of serious infection within the past 6 months

          -  test positive for TB

          -  have any uncontrolled clinically significant disease or laboratory tests

          -  require administration of prohibited medications during the study
Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial
Condition: Cardiac Arrest; Sudden Cardiac Death; Ventricular Fibrillation; Tachycardia, Ventricular
MeSH terms: Heart Arrest; Tachycardia; Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular; Death
Intervention: Epinephrine; Metoprolol
Intervention description: Epinephrine (1 mg) IV additional doses; Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses
Intervention MeSH terms: Metoprolol; Epinephrine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac arrest; Sudden Cardiac Death; Ventricular Fibrillation; Pulseless Ventricular Tachycardia; Cardiopulmonary resuscitation

Summary:

      The purpose of this research study is to evaluate the effectiveness of metoprolol, a "beta
      blocker," in treating patients in the hospital with a cardiac arrest. It will be given
      intravenously (given into a vein). The subjects who will take part in this study are 18 years
      of age or older, are experiencing a cardiac arrest in the hospital, and are in a life
      threatening situation. Patients who develop a cardiac arrest require prompt electrical
      defibrillation (electrical shocks) to restore the normal beating rhythm of the heart. In
      patients who do not respond to electrical defibrillation, current standard of care recommends
      the use of medications which have been shown to be of unknown benefit. Some people recover
      from a cardiac arrest, but many people do not. We want to learn whether giving metoprolol
      will improve survival of patients with a cardiac arrest. A total of 100 patients will be
      enrolled in the study. Patients will receive either the standard of care with the drug
      epinephrine or the standard of care plus metoprolol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients age > 18 years of age who develop an in-hospital VF or pVT arrest which
             persists after three or more precordial shocks.

          -  Patients who develop an in-hospital cardiac arrest due to asystole or PEA which
             subsequently converts to VF or pVT will be included.

        Exclusion Criteria:

          -  Pediatric patients

          -  Pregnancy

          -  Age < 18 years of age

          -  Patients who develop VF or pVT in the emergency room, operating room or surgical
             intensive care unit.
D2212C00002 J-Phase II Study
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: tralokinumab cohort 1; tralokinumab cohort 2; Placebo
Intervention description: Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor; Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Japan; Phase2; Safety; Tolerability; Idiopathic Pulmonary Fibrosis; IPF; CAT-354; Tralokinumab

Summary:

      The purpose of the study is to evaluate the safety and tolerability of multiple-doses of
      tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Confirmed IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of
             diagnosis of IPF

          -  Mild to moderate IPF to include all of the following at Visit 1

               1. FVC ≥ 50% and ≤ 90% predicted normal

               2. Partial pressure of oxygen in arterial blood (PaO2) of ≥ 55 mmHg on room air, or
                  oxygen saturation by pulse oximetry (SpO2) of ≥ 90% on room air at rest

               3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) ≥ 30% and ≤
                  90% predicted normal

        Exclusion Criteria:

          -  History of clinically significant environmental exposure (eg, domestic and
             occupational) to a known cause of pulmonary fibrosis

          -  Diagnosis of connective tissue disease or drug toxicity as the likely cause of the
             interstitial disease

          -  A suspected IPF exacerbation not fully resolved and treatment completed ≤ 14 days
             prior to Visit 1

          -  A suspected IPF exacerbation during the screening period

          -  A FEV1/FVC ratio < 0.70 at the time of Visit 1 (postbronchodilator)

          -  The extent of emphysema on the HRCT is greater than the extent of fibrosis
Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Indacaterol 27.5 mcg; Indacaterol 37.5; Indacaterol 55 mcg; Indacaterol 75 mcg; Indacaterol 150 mcg; Placebo
Intervention description: indacaterol 27.5 mcg twice daily inhaled once via inhaler; Indacaterol 37.5 mcg once daily, inhaled once via inhaler; Indacaterol 55 mcg once daily, inhaled once via inhaler; Indacaterol 75 mcg once daily, inhaled once via inhaler; Indacaterol 150 mcg once daily, inhaled once via inhaler; Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: wheezing, short of breath, laba, inhaler

Summary:

      The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and
      27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Asthma for at least 6 months, using inhaled corticosteroid for at least one month,
             foreced breath test less than below the normal value of the general population, -show
             an immediate improvement in breathing when given albuterol

        Exclusion Criteria:

          -  patients who have smoked in the past 6 months or are currently smoking, including
             those who smoked more than a pack of cigarettes a day for at least 10 years, -patients
             who have a history of life-threatening asthma, -patients who have had an astham
             attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or
             ER visit, -patients who have had a respiratory tract infection or worsening asthma
             between screening or run-in periods, patients requring use of other asthma-related
             drugs during the trial, other protocol-defined inclusion/exclusion may apply
The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Intervention: ALN-TTR02 (patisiran) administered by intravenous (IV) infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic

Summary:

      The purpose of this study is to evaluate the safety and tolerability of long-term dosing with
      ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously received and tolerated ALN-TTR02 (patisiran) in Study ALN-TTR02-002.

          -  Adequate Karnofsky performance status, liver function, and renal function.

        Exclusion Criteria:

          -  Pregnant or nursing.

          -  Has had a liver transplant.

          -  Has a New York Heart Association heart failure classification >2.

          -  Has unstable angina.

          -  Has uncontrolled clinically significant cardiac arrhythmia.