bioihbjkbjnl/mcl2 huggingface dataset:
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Almotriptan Malate
Intervention description: Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
Intervention MeSH terms: Almotriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 447.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Migraine; Almotriptan Malate; Headache; Triptan

Summary:

      The purpose of this study is to evaluate the long-term safety of almotriptan malate (a
      migraine headache medication) in the treatment of migraine headaches in adolescents for up to
      one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a history of migraine for at least one year

          -  Have an average of 1 - 14 migraines per month for the 6 months prior to study entry

          -  Able to swallow oral medication

          -  Able to complete a headache diary

          -  Only taking one migraine preventive medication and on the same dose of that medication
             for at least 30 days before entering the study)

        Exclusion Criteria:

          -  Have an allergy to almotriptan malate or have stopped taking almotriptan malate due to
             side effects

          -  Have 15 or more days within a month in which you have a headache

          -  Usually experience migraine aura (most common symptoms being visual disturbances or
             tingling sensations before migraine pain begins) without a headache

          -  Experience more than 6 non-migraine headaches per month
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: CT-P10; Rituxan
Intervention description: 375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.; 375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by
      overall response rate at 7 months
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma

          -  Ann Arbor Stage II, III or IV

        Exclusion Criteria:

          -  Has receive rituximab

          -  Allergies or hypersensitivity to murine, chimeric, human or humanised proteins

          -  Previous treatment for NHL

          -  Any malignancy

          -  Current or recent treatment with any other investigational medicinal product or device

          -  pregnant or lactating
CoQ10 and Prednisone in Non-Ambulatory DMD
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Prednisone; Coenzyme Q10
Intervention description: Prednisone 0/75 mg/kg/day.; serum levels of greater or equal to 2.5 micrograms/mL.
Intervention MeSH terms: Ubiquinone; Coenzyme Q10; Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Muscular dystrophy; Duchenne; CoQ10; prednisone

Summary:

      This study will help determine if CoQ10 and prednisone, alone and as a combination decrease
      the decline in cardiopulmonary and skeletal muscle function that occurs in the wheelchair
      confined phase of DMD. Participants who are enrolled in this study should not have taken any
      corticosteroids within the last six months. This is a 13-month, prospective, randomized study
      comparing a daily prednisone arm (0.75mg/kg/day), a CoQ10 arm (serum of greater than 2.5
      ug/mL) and a combination arm (prednisone and CoQ10) with an enhanced standard of care arm in
      wheelchair confined males age 10 to 18 years with an established DMD diagnosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 10-18 years

          -  Non-ambulatory (primary mode of transportation is via wheelchair for 3 years or less)

          -  Confirmed DMD diagnosis

          -  Steroid-naive for the 6 months prior to screening

          -  Stable dose of b-blocker or ACE inhibitor medication for the 6 months prior to
             screening, if taking either of these medications

          -  Ability to provide reproducible repeat QMT grip score within 15% of first assessment
             score

          -  Has not participated in other therapeutic research protocol within the last 6 months
             prior to screening

          -  Ability to swallow tablets

        Exclusion Criteria:

          -  Failure to achieve one or more of the diagnostic inclusion criteria cited above

          -  Symptomatic DMD carrier

          -  Use of carnitine, other amino acids, creatine, glutamine, CoQ10 or any herbal
             medicines (this would not include herbal teas unless they are consumed daily with
             intended medicinal effect) within the last 3 months

          -  History of significant concomitant illness or significant impairment of renal or
             hepatic function, or other contraindication to steroid therapy

          -  Positive PPD

          -  No prior exposure to chickenpox and no immunization against chicken pox

          -  Baseline serum CoQ10 level of 5.0mg/ml or greater
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
Condition: Chronic Hepatitis C; Genotype 4 Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Intervention: Simeprevir; Sofosbuvir
Intervention description: Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12.; Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.
Intervention MeSH terms: Sofosbuvir; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic hepatitis C; Genotype 4 chronic hepatitis C; Simeprevir; Sofosbuvir

Summary:

      The purpose of this study is to show superiority of simeprevir (SMV) in combination with
      sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite
      of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in
      combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in
      study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior
      relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in
      this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with confirmed hepatitis C virus (HCV) with HCV RNA greater than (>) 10000
             international unit per milliliter (IU/mL)

          -  Subjects who are treatment naive or treatment-experienced.

          -  Subjects must have documentation of a liver biopsy or fibroscan or agree to have one
             during screening

          -  Subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, CT scan or
             magnetic resonance imaging [MRI]) within 6 months before the screening visit (or
             during the screening period) with no findings suspicious for hepatocellular carcinoma
             (HCC)

          -  Women of childbearing potential or men with a female partner of childbearing potential
             must agree to use an effective form of contraception, or not be heterosexually active,
             or of nonchildbearing potential

        Exclusion Criteria:

          -  Evidence of clinical hepatic decompensation

          -  Any liver disease of non-HCV etiology

          -  Subjects with a past history of treatment with an approved or investigational DAA

          -  Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2)
             (positive HIV-1 or HIV-2 antibodies test at screening)

          -  Infection/co-infection with HCV non-genotype 4
Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; Azilect®
Intervention description: Once daily; tablet; orally; 16 weeks; 1 mg daily; tablet; orally; 16 weeks
Intervention MeSH terms: Rasagiline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Rasagiline; Azilect; Parkinson´s Disease; Motor fluctuations

Summary:

      The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety
      of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese
      patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of
      idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in
      patients with end of dose fluctuations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with idiopathic PD.

          -  Patients with motor fluctuations averaging at least 1 hour daily in the "OFF" state
             during the waking hours.

          -  Patients with a Modified Hoehn and Yahr stage ≤3 in the "ON" state.

          -  Patients taking optimised levodopa or dopa decarboxylase inhibitor (DDI) therapy; they
             must be stable for at least 14 days prior to baseline.

          -  Patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses
             of levodopa.

          -  Patients who have demonstrated the ability to keep accurate "24-hour" diaries prior to
             randomisation.

        Exclusion Criteria:

          -  Patients with a clinically significant or unstable medical or surgical condition that
             would preclude his/her safe and complete study participation.

          -  Patients with a clinically significant or unstable vascular disease.

          -  Patients who have undergone a neurosurgical intervention of PD.

          -  Patients with severe disabling dyskinesias.

          -  Patients with a clinically significant psychiatric illness, including a major
             depression, which compromises their ability to provide consent or participate fully in
             the study.

          -  Patients with a Mini Mental State Examination (MMSE) score ≤24.

          -  Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious
             lesion.

        Other inclusion and exclusion criteria may apply.
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Placebo; TMC435; Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b); Ribavirin (RBV)
Intervention description: 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks; 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks; One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.; 200-mg tablets of ribavirin (Copegus or Rebetol) (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Peginterferon alfa-2b; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 393.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; TMC435; HCV; Hep C; genotype 1

Summary:

      The purpose of this study is to investigate the effectiveness and safety of TMC435 compared
      with placebo in participants who are infected with genotype 1 hepatitis C virus who have
      never received treatment before. Participants will also receive peginterferon alfa-2a or
      peginterferon alfa-2b and ribavirin as part of their treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 1 hepatitis C infection (confirmed at screening)

          -  Participant has not received any prior treatment for hepatitis C

          -  Participant must have had a liver biopsy within 3 years before screening (or between
             the screening and baseline visit) showing chronic hepatitis C infection

          -  Must agree to use 2 forms of effective contraception throughout study (both males and
             females)

        Exclusion Criteria:

          -  Infection with HIV or non genotype 1 hepatitis C

          -  Liver disease not related to hepatitic C infection

          -  Hepatic decompensation

          -  Significant laboratory abnormalities or other active diseases

          -  Pregnant or planning to become pregnant
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Xalatan; Xalacom
Intervention description: latanoprost 0.005%, one rop once daily in evening; latanoprost 0.005% adn timolol 0.5%, one drop, once daily
Intervention MeSH terms: Latanoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in
      Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in
      efficacy and similarity of safety between Xalacom and Xalatan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4
             weeks or more.

        Exclusion Criteria:

          -  History of no-response to timolol

          -  History of trabeculectomy

          -  History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone furoate nasal spray (MFNS); Matching placebo nasal spray
Intervention description: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days; Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 351.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study seeks to prospectively demonstrate that Nasonex is better than placebo in
      relieving nasal congestion in patients with seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A subject must be 12 years of age or older, of either sex, and of any race.

          -  A subject must have at least a 2-year history of SAR which exacerbates during the
             study season.

          -  A subject must have a positive skin prick test response to an appropriate seasonal
             allergen at Visit 1.

          -  A subject must be clinically symptomatic at the Screening and Baseline Visits.

        Exclusion Criteria:

          -  A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.

          -  A subject who has had an upper respiratory tract or sinus infection that required
             antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or
             who has had a viral upper respiratory infection within 7 days prior to the Screening
             Visit.

          -  A subject who has used any drug in an investigational protocol in the 30 days prior to
             the Screening Visit.

          -  A subject who is participating in any other clinical study.

          -  A subject who is part of the staff personnel directly involved with this study.

          -  A subject who is a family member (parent, spouse, or sibling) of the investigational
             study staff.

          -  A female subject who is breast-feeding, pregnant, or intends to become pregnant.

          -  A subject previously randomized into this study.

          -  A subject who has a family member (parent, spouse, or sibling) currently enrolled in
             this study.
Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 13vPnC; PPSV23; 20vPnC
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine; Pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 875.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal
      conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal
      vaccination
    

Eligibility criteria:

        Inclusion Criteria

          1. Male or female adults 65 years of age or greater.

          2. Adults determined by clinical assessment, including medical history and clinical
             judgment, to be eligible for the study, including adults with preexisting stable
             disease, defined as disease not requiring significant change in therapy in the
             previous 6 weeks or hospitalization for worsening disease within 12 weeks before
             receipt of investigational product.

          3. Female subject of nonchildbearing potential; male subject not able to father children
             or who is able to father children and willing to use a highly effective method of
             contraception.

          4. Male or female adults who meet 1 of the following:

               1. Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to
                  5 years prior to vaccination in the study, and no prior 13vPnC vaccination
                  (Cohort A).

               2. Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in
                  the study, and no prior PPSV23 vaccination (Cohort B).

               3. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or
                  equal to 1 year prior to vaccination in the study) (Cohort C).

        Exclusion Criteria

          1. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
             pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
             or without dialysis, clinically unstable cardiac disease, or any other disorder that,
             in the investigator's opinion, excludes the subject from participating in the study.

          2. History of microbiologically proven invasive disease caused by S pneumoniae.