bioihbjkbjnl/mcl2 huggingface dataset:
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
Condition: Dermatitis; Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Bepotastine besilate; ketotifen fumarate
Intervention description: Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day; Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day
Intervention MeSH terms: Ketotifen; Bepotastine besilate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 303.0
Sex: All
Minimum age: 7 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate
      dry syrup in the change in the severity of pruritus after the treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged between 7 and 15 years

          -  Patients giving assent and whose legal guardian giving informed consent

          -  Outpatients

          -  Patients diagnosed as atopic dermatitis

          -  Patients who require the treatment with topical corticosteroid on areas other than
             face, head and neck

          -  Patients whose diaries can be properly maintained

          -  Patients who have 2 grades or more pruritus score

        Exclusion Criteria:

          -  Patients with bronchial asthma who require concomitant use of the corticosteroid

          -  Patients who have been undergoing specific desensitization therapy or nonspecific
             immunomodulation therapy or phototherapy

          -  Patients with current or previous history of drug hypersensitivity

          -  Patients who have been treated with Bepotastine besilate in the past

          -  Patients who have; a skin infection, or with zooparasite such as scabies and
             pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer,
             or profound heat burn or frostbite of the severity higher than the grade 2; on areas
             where topical corticosteroid is applied

          -  Patients who have spastic disease such as epilepsy

          -  Patients who concurrently have renal function abnormalities that may cause safety
             problems

          -  Patients who do not give consent to use birth control

          -  Pregnant patients, at risk of pregnancy or breastfeeding

          -  Patients who had participated in any clinical trial in the last 12 weeks
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL
Intervention description: Tablets administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in
      adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV-infected males and non-pregnant/non-lactating females

          -  Treatment-naïve or treatment-experienced individuals

          -  Compensated cirrhosis at Screening

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Condition: TOBACCO USE CESSATION
Intervention: Standard Patch Treatment; 24-weeks of nicotine patch
Intervention description: 8-weeks of nicotine patch + 16-weeks of placebo; 24-weeks of 21mg nicotine patch
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 568.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This randomized double-blind, placebo-controlled will determine the relative efficacy of
      standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After
      completing the eligibility screening, 600 treatment-seeking smokers will be randomized to
      receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or
      extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral
      counseling. The primary outcome will be biochemically verified abstinence from smoking at the
      end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after
      treatment is discontinued), and time to failure. We hypothesize that ET will produce
      significantly higher quit rates than ST; however, the benefit of ET will last only so long as
      treatment is continued. Support for this hypothesis would indicate that maintenance therapy
      with TN should be considered.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females of descent between the ages of 18-65 who smokes at least 10
             cigarettes/day and are seeking smoking cessation treatment.

          2. Based on the medical history, physical and laboratory examination, premenopausal
             female subjects must consent to practice an effective form of contraception during
             study.

          3. Following orientation by the research staff, subjects must sign written informed
             consent for all study procedures.

        Exclusion Criteria:

          1. Women who are pregnant, planning a pregnancy, or lactating.

          2. Current medical problems for which TN is contraindicated including allergy to
             nicotine, uncontrolled hypertension, unstable angina, serious arrhythmia, heart attack
             or stroke within the past 6 months, liver and/or kidney failure in the last 6-months
             and current diabetes.

          3. Current treatment of cancer or diagnosed with cancer in the past 6 months

          4. Current DSM IV substance use disorders (dependence involving alcohol, cocaine,
             marijuana or stimulants, benzodiazepines).

          5. Current use of TN or other forms of NRT.

          6. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within
             past 14 days, antipsychotics, endogenous steroids, and antidepressants (including
             wellbutrin or bupropion).
An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra]
Intervention description: tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multi-center study in a local environment will evaluate the safety and the
      effect on disease activity with regard to reduction in signs and symptoms over 6 months of
      treatment in patients with moderate to severe active rheumatoid arthritis who experienced an
      inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an
      intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in
      combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >/=18 years of age

          -  Moderate to severe rheumatoid arthritis defined as DAS 28>3.2

          -  Body weight </=150 kg

          -  Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any
             time prior to study start

          -  Inadequate clinical response to a stable dose of a non-biologic DMARD

        Exclusion Criteria:

          -  Major surgery within 8 weeks prior to screening or planned major surgery within 6
             months following enrollment

          -  Rheumatic autoimmune disease other than rheumatoid arthritis (RA)

          -  Functional class IV as defined by the ACR classification

          -  History or current inflammatory joint disease other than RA

          -  Previous treatment with any cell depleting therapy

          -  Previous treatment with methotrexate

          -  Previous treatment with tocilizumab

          -  Previous treatment with any biologic drug that is used in the treatment of RA
Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Levetiracetam
Intervention description: Pharmaceutical form: Film-coating tablets
Concentration: 250 mg/ 500 mg
Route of administration: oral use
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy, partial; Keppra; Levetiracetam

Summary:

      The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial
      of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their
      standard concomitant AEDs
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059

          -  Patients/the parent or guardian wish to continue treatment with L059 and to enter N165
             Follow-up Study, and also the investigator admit the necessity of the repeated intake
             of the investigational drug for the patients.

        Exclusion Criteria:

          -  Patients who had not participate in N165 Clinical Trial of L059.

          -  Patients who had participated in N165 Clinical Trial of L059 with no intention of
             entering the follow-up study taking the same medication.

          -  Patients had not been in compliance with requirements of Protocol for N165 Clinical
             Trial of L059 in the course of the study.
Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: infliximab infusion; AZA placebo caps; infliximab (IFX) infusion; azathioprine (AZA) caps; infliximab (IFX) placebo infusion; azathioprine (AZA) caps
Intervention description: Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules; AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22; AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22
Intervention MeSH terms: Infliximab; Azathioprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 508.0
Sex: All
Minimum age: 21 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Crohn's Disease; infliximab; azathioprine; Remicade; SONIC

Summary:

      The purpose of this study is to assess the safety and effectiveness of three different
      treatments for patients with Crohns disease who have not responded to previous treatment with
      a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients
      will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an
      immunosuppressant or drug used to suppress the immune system) or a combination of both for up
      to 34 weeks. This research study will involve approximately 500 patients. The main study
      involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks
      (approximately 5 months) is optional for patients who successfully complete the main study. A
      country-specific study extension of open label infliximab treatment for an additional 1 year
      is optional for patients who successfully complete the main study extension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Crohns Disease for at least 6 weeks

          -  Moderate to severe disease activity (CDAI >= 220 and <=450)

          -  No history of azathioprine, 6-MP (6 Mercaptopurine), or biologic treatments

          -  Are either: Corticosteriod-dependent, OR considered for a 2nd (or greater) course of
             corticosteriod, OR 5-ASA failures, Or Budesonide failures

        Exclusion Criteria:

          -  History of abdominal surgery within the last 6 months

          -  Have an ostomy or stoma [An operation to create an opening from an area inside the
             body to the outside]

          -  Are pregnant, nursing, or planning pregnancy (both men and women)

          -  Serious simultaneous illness that could interfere with study participation

          -  Use of any investigational drug within 30 days

          -  Have a concomitant diagnosis or any history of congestive heart failure

          -  Weigh more than 140 kilograms (or 310 pounds)
PUFAs and Left Ventricular Function in Heart Failure
Condition: Dilated Cardiomyopathy; Heart Failure
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Intervention: n-3 PUFAs; Placebo
Intervention description: 1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.; 1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: n-3 PUFAs; Heart Failure; Dilated cardiomyopathy; Ejection Fraction; Exercise Capacity

Summary:

      The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular
      systolic function in patients with stable chronic HF secondary to nonischemic dilated
      cardiomyopathy (NICM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with a diagnosis of non ischemic cardiomyopathy (the absence of coronary
             artery disease,defined as the absence of stenosis > 50%, was confirmed by angiography
             performed at the time of the diagnostic workup of the cardiomyopathy)

          -  LV systolic dysfunction (defined as an EF < 45%)

          -  Stable clinical conditions with minimal or no symptoms for at least three month

          -  Evidence-based medical treatment at maximum tolerated target doses for at least six
             month

        Exclusion Criteria:

          -  presence of symptoms or evidence of CAD diagnosed through noninvasive tests;

          -  peripheral arterial disease;

          -  presence of congenital or primary valvular heart disease;

          -  persistent atrial fibrillation;

          -  inability to perform bicycle ergometry for noncardiac causes;

          -  moderately to severely reduced functional capacity;

          -  NYHA functional class IV;

          -  poor acoustic windows limiting the ability to assess echocardiographic measurements;

          -  chronic lung disease;

          -  advanced renal disease (eGFR < 30 mL/min/1.73 m2);

          -  advanced liver disease;

          -  any disease limiting life expectancy to one year or less;

          -  contraindications to study drugs;

          -  concomitant participation in other research studies
Meta-Iodobenzylguanidine (123I-mIBG) Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Intervention: 123I-mIBG (meta-iodobenzylguanidine)
Intervention description: Single Dose
Intervention MeSH terms: 3-Iodobenzylguanidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 515.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Heart Failure; nuclear cardiology; sympathetic innervation; 123I-mIBG

Summary:

      The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to
      predict cardiac outcome in subjects with heart failure and in comparison to subjects without
      cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study subjects must be adults with an established diagnosis of heart failure (New York
             Heart Association Class II or III) and reduced left ventricular ejection fraction
             (LVEF) (≤ 35%) or be healthy volunteers without heart disease.

        Exclusion Criteria:

          -  Healthy volunteers were not eligible if they had a history of diabetes mellitus,
             signs/symptoms of neurological disease (e.g., Parkinson's Disease, multiple system
             atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic
             nervous system.

          -  Subjects with New York Heart Association Class I or IV heart failure were not
             eligible.

          -  Subjects were excluded if they had previously received 123I-mIBG or 131I-mIBG or
             participated in a clinical study involving investigational medicinal product or
             devices within 30 days.

          -  Subjects that had a pacemaker or had received defibrillation, anti-tachycardia pacing
             or cardioversion to treat a previous arrhythmic event or had an ICD inserted within 30
             days before study entry are not eligible.
Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: adalimumab; Placebo; adalimumab
Intervention description: Pre-filled syringe. See arm for more detail; Pre-filled syringe. See arm for more detail; Pre-filled syringe. See arm for more detail
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and
      demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of
      40 mg adalimumab every other week.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject > 18 years of age

          -  Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification
             criteria and has a disease duration for a minimum of three months

          -  Subject must meet the following two criteria: a) At least 6 swollen joints out of 66
             assessed, or b) At least 6 tender joints out of 68 assessed

          -  If a subject is on MTX, the doses must be stable for at least 4 weeks prior to
             Screening blood draw and follow standard recommendations for MTX treatment

          -  Subject is judged to be in generally good health as determined by the principal
             investigator

        Exclusion Criteria:

          -  Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab,
             etanercept, certolizumab pegol or golimumab) including adalimumab

          -  Subject has a history of acute inflammatory joint disease of different origin other
             than RA

          -  Subject has been treated with any investigational biologic agents

          -  Subject considered by the investigator, for any reason, to be an unsuitable candidate
             for the study

          -  Female subject who is pregnant or breast-feeding or considering becoming pregnant
A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Peficitinib
Intervention description: Oral Tablet
Intervention MeSH terms: Peficitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 843.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Smyraf; Rheumatoid Arthritis; Peficitinib; ASP015K

Summary:

      This study evaluated the safety and efficacy of long-term administration of ASP015K in
      patients who have completed Phase IIb or Phase III studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as
             specified in the protocol

          -  The subject himself/herself wishes to continue taking the study drug, and the
             investigator or sub-investigator deems continued administration to be necessary or
             appropriate

        Exclusion Criteria:

          -  There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic
             infection, tuberculosis infection, or malignancy is suspected

          -  Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for
             human immunodeficiency virus (HIV) infection

          -  Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or
             a history of it

          -  Subject has a clinically significant infection or disease (requiring hospitalization
             or parenteral therapy)

          -  Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52
             of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.