bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: ZOSTAVAX™; Placebo to ZOSTAVAX™; Influenza Vaccine
Intervention description: A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant); A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant); A single open-label administration of 0.5 mL intramuscular injection on Day 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 882.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211)
      administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine
      (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the
      noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella
      zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of
      geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the
      noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza
      virus strain-specific GMT antibody responses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has history of varicella or residence in a VZV-endemic area for ≥30 years

          -  Is male, female not of reproductive potential, or female of reproductive potential and
             has a negative pregnancy test and agrees to avoid becoming pregnant throughout the
             study

        Exclusion Criteria:

          -  Has history of hypersensitivity to any vaccine component

          -  Has previously received any varicella or zoster vaccine

          -  Has received an influenza vaccine for the 2015-16 season

          -  Has history of Herpes zoster

          -  Has received immunoglobulin, monoclonal antibodies, or any blood products within 5
             months before study vaccination

          -  Is pregnant or breastfeeding, or expecting to conceive during the study

          -  Has used immunosuppressant therapy

          -  Has known or suspected immune dysfunction

          -  Has experienced Guillain-Barré syndrome within 6 weeks

          -  Has severe thrombocytopenia or any other coagulation disorder
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Intervention: 13vPnC
Intervention description: "First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 193.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the
      13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2 to 6 month-old infant

          -  Available for entire study period

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal vaccine.

          -  Previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Contraindication to vaccination with a pneumococcal conjugate vaccine.

          -  Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate any type of injection.

          -  Known or suspected immune deficiency or suppression.
Growth Hormone Use in Adults With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Intervention: Nutropin AQ
Intervention description: 0.0125 mg/kg/day
Intervention MeSH terms: Hormones
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 16 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The main research question this protocol aims to answer is whether treatment with growth
      hormone will impact body composition, quality of life, and energy balance in PWS adults, and
      if there is a loss of effects after cessation of treatment for at least 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  16 to 60 years old

          -  Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing
             (e.g., mPCR)

          -  Low IGF-1 level (e.g.,≤25%) at baseline

          -  Ability to provide informed consent or availability of a suitable legally authorized
             representative

        Exclusion Criteria:

          -  Pregnancy

          -  Previous treatment with growth hormone

          -  Uncontrolled endocrine disease, (i.e. diabetes or thyroid)

          -  History of severe scoliosis

          -  Heart disease

          -  Uncontrolled high blood pressure or history of stroke

          -  Morbid obesity (using PWS growth charts)

          -  Severe sleep apnea or known breathing difficulties/obstruction (as per history or
             diagnostic testing results
A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Ticagrelor; Clopidogrel
Intervention description: Ticagrelor (AZD6140) 90 mg twice daily dose (BD); Clopidogrel 75 mg once daily dose (ODD)
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18624.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ACS; Acute coronary syndrome; Heart attack; Unstable angina; Coronary artery disease

Summary:

      Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications
      work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment
      for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both
      heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by
      the formation of a blood clot in an artery that partially or totally blocks the blood supply
      to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine
      which drug, when either is used in conjunction with aspirin, is better at reducing deaths
      from vascular causes, future heart attacks and/or strokes in patients with ACS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 years or older who has been hospitalised for chest pain and
             potential ACS

          -  Females of child-bearing potential must have a negative pregnancy test at enrollment
             and be willing to use 2 methods of reliable contraception

        Exclusion Criteria:

          -  Persons with moderate or severe liver disease

          -  Persons who have already been treated with an invasive (angioplasty) procedure for the
             current episode of ACS

          -  Persons who are being treated with blood clotting agents that cannot be stopped
Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients With MPS VI
Condition: Mucopolysaccharidosis VI
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis VI
Intervention: Placebo; N-acetylgalactosamine 4-sulfatase
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 39.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance
      endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in
      the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patient consent

          -  Patient must be seven years of age or older

          -  Patient must have documented biochemical or genetic proof of MPS VI

          -  The patient must be able to walk independently at least 5 meters and no more than 270
             meters in the first 6 minutes, or no more then 400 meters total in 12 minutes, in the
             screening 12-minute walk test

          -  If female of childbearing potential, patient must have a negative pregnancy test

        Exclusion Criteria

          -  Patient is under consideration for or has undergone a successful bone marrow
             transplant (BMT)

          -  Patient refuses or is unable to complete all screening evaluations

          -  Pregnant or lactating patient

          -  Patient has received an investigational drug within 30 days prior to study enrollment

          -  Patient has been previously treated with rhASB

          -  Patient has a medical condition, serious intercurrent illness, or other extenuating
             circumstance that may significantly confound study results or decrease study
             compliance

          -  The patient has clinically significant spinal cord compression

          -  The patient has known hypersensitivity to rhASB or to components of the active or
             placebo test solutions
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267; Placebo
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267; Tablet
Intervention MeSH terms: Ritonavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hepatitis C; Genotype 1b; Cirrhotic; Treatment Experienced; Treatment Naive; Japanese; ombitasvir; paritaprevir; ritonavir; VIEKIRAX Combination Tablets

Summary:

      This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies:
      Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2
      (SS2) will be open label and enroll subjects with compensated cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HCV-infection prior to study enrollment

          -  Screening laboratory result indicating HCV subgenotype 1b infection

          -  Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening

          -  Voluntarily sign an informed consent

          -  Females must be practicing specific forms of birth control on study treatment, or be
             post-menopausal for more than 2 years or surgically sterile

        Exclusion Criteria:

          -  Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) or any HCV
             genotype other than subgenotype 1b

          -  Prior therapy with direct acting antiviral agents for the treatment of HCV, including
             telaprevir, simeprevir and boceprevir

          -  Any cause of liver disease other than chronic HCV-infection, including but not limited
             to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease;
             autoimmune hepatitis; alcoholic liver disease; drug-related liver disease; clinically
             significant laboratory abnormalities; uncontrolled clinically significant disease,
             disorder or medical illness
Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: Idebenone; Idebenone; Placebo
Intervention description: Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients > 45 kg/99 lbs: idebenone 900 mg/day; Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients > 45 kg/99 lbs: idebenone 2250 mg/day; Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
Intervention MeSH terms: Ubiquinone; Idebenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Friedreich's Ataxia; Idebenone; ICARS

Summary:

      This study is meant to assess the effectiveness of idebenone on neurological outcome measures
      in patients with Friedreich's Ataxia over a 6 months period.
    

Eligibility criteria:

        Inclusion criteria:

          -  Documented diagnosis of Friedreich's Ataxia (FRDA) with confirmed FRDA mutations

          -  Patients 8 - 17 years of age at baseline

          -  Patients with a body weight greater than 25 kg/55 lbs at baseline

          -  Patients able to walk at least 10 meters without accompanying person (ICARS Walking
             Capacities score ≤6) at screening and baseline

          -  Patients who in the opinion of the investigator are able to comply with the
             requirements of the study, including swallowing the study medication

          -  Negative urine pregnancy test at screening and baseline (female patients of
             childbearing potential)

        Exclusion criteria:

          -  Treatment with idebenone, Coenzyme Q10 or vitamin E (if taken at a dose 5 times above
             the daily requirement) within the past month

          -  Patients with International Cooperative Ataxia Rating Scale (ICARS) score of greater
             than 54 or less than 10 at screening

          -  Pregnancy and/or breast-feeding

          -  Clinically significant abnormalities of clinical hematology or biochemistry including,
             but not limited to, elevations greater than 1.5 times the upper limit of normal of
             Aspartate Aminotransferase (AST; also known as GOT), Alanine Aminotransferase (ALT;
             also known as GPT) or creatinine

          -  History of abuse of drugs or alcohol

          -  Participation in the previous (Phase II) study of idebenone at the National Institutes
             of Health (NIH)

          -  Participation in a trial of another investigational drug within the last 3 months
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Condition: Schizoaffective Disorder; Psychotic Disorder
MeSH terms: Psychotic Disorders
Intervention: Paliperidone ER; Paliperidone ER; Placebo
Intervention description: 6mg/day paliperidone er for 6 weeks; 12mg/day paliperidone er for 6 weeks; Placebo for 6 weeks
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 316.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizoaffective Disorder; antipsychotic; paliperidone; placebo

Summary:

      The purpose of this study is to measure the effectiveness and assess the safety of two
      dosages of the antipsychotic paliperidone extended-release (ER) in patients who are
      experiencing an acute episode of schizoaffective disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of
             schizoaffective disorder

          -  A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of >= 60

          -  A score of >= 16 on Young Mania Rating Scale (YMRS) or a score of >= 16 on the
             Hamilton Depression Rating Scale (HAM-D 21)

        Exclusion Criteria:

          -  A primary active mental illness diagnosis other than schizoaffective disorder

          -  Patients with first episode psychosis

          -  Active substance dependence within previous 6 months

          -  Treatment with clozapine within 6 months of randomization

          -  A history of treatment resistance, defined by failure to respond to 2 adequate trials
             of antipsychotic medication

          -  Pregnancy, breast-feeding, or planning to become pregnant
A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: bevacizumab [Avastin]
Intervention description: Intervenous repeating dose
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 607.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to
      a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated
      time of study treatment is until confirmed evidence of disease progression, and the target
      sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  metastatic pancreatic cancer (adenocarcinoma);

          -  good liver, kidney, and bone marrow function.

        Exclusion Criteria:

          -  previous systemic treatment for metastatic pancreatic cancer;

          -  pregnant or lactating females;

          -  fertile men, or women of childbearing potential, not using adequate contraception;

          -  major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to study treatment start;

          -  current or recent treatment (within 30 days prior to starting study treatment) with
             another investigational drug, or participation in another investigational study.
Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Placebo
Intervention description: Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI); Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 415.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; adults; β2-agonist; indacaterol

Summary:

      This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against
      placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients eligible to participate in the study extension, by definition, will have met
             the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal
             criteria for the core study B2335S at Visit 14 (the last visit of the core study
             B2335S and the first visit of the extension study B2335SE).

          -  In addition the following inclusion/exclusion criteria specified below must be met.

               1. Patients must complete Stage 2 of the core study B2335S (NCT00463567).

               2. Written informed consent to participate in the extension must be obtained.

               3. Patients must be able to comply with all study requirements.

        Exclusion Criteria:

          -  Patients who were randomized to open-label tiotropium in Study B2335S.

          -  Patients who participated in Stage 1 of the core study (B2335S).

          -  Patients discontinued irrespective of the reason from Stage 2 of the core study.

          -  Patients who fail to comply with the core protocol requirements and procedures.

          -  Concomitant medical conditions that may interfere with interpretation of study results
             as defined in the core study protocol.

          -  Patients who in the Investigator's opinion should not participate in the extension
             study.

        Other protocol-defined inclusion/exclusion criteria may apply