bioihbjkbjnl/mcl2 huggingface dataset:
Extension Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: NS-065/NCNP-01
Intervention description: Received during weekly intravenous infusions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Low Dose cohort of 40 mg/kg and High Dose cohort of 80 mg/kg
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 4 Years
Maximum age: 10 Years
Healthy volunteers: No

Summary:

      This is an open-label, extension study of NS-065/NCNP-01 administered intravenously once
      weekly for an additional 192 weeks to boys with DMD who complete Study NS-065/NCNP-01-201.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed Study NS-065/NCNP-01-201 through Week 25.

          2. Willing and able to comply with scheduled visits, investigational product
             administration plan, and study procedures.

          3. Stable dose of glucocorticoid (GC), and is expected to remain on the stable dose for
             the duration of the study.

        Exclusion Criteria:

          1. Serious or severe adverse event in Study NS-065/NCNP-01-201 that precludes safe use of
             NS-065/NCNP-01.

          2. Patient had a treatment which was made for the purpose of dystrophin or its related
             protein induction after completion of Study NS-065/NCNP-01-201.

          3. Patient took any other investigational drugs after completion of Study
             NS-065/NCNP-01-201.

          4. Patient was judged by the investigator and/or the Sponsor that it was not appropriate
             to participate in the extension study for other reasons.
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide; Placebo
Intervention description: Administered intravenously (IV) at the end of hemodialysis; Administered intravenously at the end of hemodialysis
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clinical Trial, Phase 2; Renal Dialysis; Secondary Hyperparathyroidism; Parathyroid hormone

Summary:

      The purpose of this study is to characterize the safety and tolerability and efficacy of
      multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of
      secondary hyperparathyroidism (HPT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject provides written informed consent.

          -  Intact parathyroid hormone (PTH) at least 350 pg/mL.

          -  Corrected calcium at least 9.0 mg/dL.

          -  Hemoglobin at least 9.0 g/dL.

          -  Adequate hemodialysis three times per week.

          -  Excepting chronic renal failure, subject is judged to be in stable medical condition
             based on medical history, physical examination, and routine laboratory tests.

        Exclusion Criteria:

          -  History or symptomatic ventricular dysrhythmias.

          -  History of angina pectoris or congestive heart failure

          -  History of myocardial infarction, coronary angioplasty, or coronary artery bypass
             grafting within the past 6 months.

          -  History of or treatment for seizure disorder.

          -  Recent (3 months) parathyroidectomy.

          -  Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater
             than two times the upper limit of normal at screening.
Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma, Open-Angle
Intervention: 400 ug Brimonidine Implant; 200 ug Brimonidine Implant; Sham (no implant)
Intervention description: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.; 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.; Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and
      effects on visual function of brimonidine intravitreal implant in patients with glaucomatous
      optic neuropathy. Patients will be followed for up to 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary open-angle glaucoma in one eye

          -  Visual acuity 20/80 or better

          -  Intraocular pressure in the study eye ≤ 24 mm Hg

          -  Glaucomatous visual field loss - 7 dB to - 25 dB

        Exclusion Criteria:

          -  Known allergy to brimonidine tartrate

          -  Uncontrolled systemic disease or infection of the eye

          -  Recent eye surgery or injections in the eye

          -  Female patients who are pregnant, nursing or planning a pregnancy
A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Mavrilimumab 10 mg; Mavrilimumab 30 mg; Mavrilimumab 50 mg; Mavrilimumab 100 mg; Placebo
Intervention description: Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks.; Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks.; Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks.; Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks.; Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks.
Intervention MeSH terms: Mavrilimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 516.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Mavrilimumab; CAM-3001

Summary:

      The primary objectives of this study is to assess the safety, tolerability and efficacy of
      multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with
      moderately active Rheumatoid Arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 80 years (20 to 75 years in Japan)

          -  Written consent

          -  Diagnosis of adult onset Rheumatoid Arthritis (RA) of at least 3 months duration as
             defined by the 1987 American College of Rheumatology (ACR) classification criteria
             (Arnett et al, 1988)

          -  Treatment with methotrexate at a stable and tolerated doses

          -  Positive anti-cyclic citrullinated peptide (CCP) immuno-globulin G antibodies (more
             than [>] 5 international unit per milliliter [IU/mL]) and/or rheumatoid factor (RF >14
             IU/mL) at screening

          -  Received more than or equal to (>=) 5 milligram (mg) per week folic acid as a single
             or divided dose during the study.

        Exclusion Criteria:

          -  A rheumatic autoimmune disease other than RA

          -  A history of, or current, inflammatory joint disease other than RA or other systemic
             autoimmune disorder

          -  Subjects at a high risk of infection

          -  Subjects (male and female) of reproductive potential who are not willing to use
             contraception from screening through the end date of the trial

          -  History of methotrexate or any drug-induced lung fibrosis or pneumonitis.
Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
Condition: Skin Infection
MeSH terms: Infections; Cellulitis; Skin Diseases, Infectious
Intervention: CG400549
Intervention description: 960mg QD at fed state approx 1 hour after meal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cABSSSI; MRSA

Summary:

      Primary Objective:

      To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with
      cABSSSI (major cutaneous abscesses) due to MRSA.

      Secondary Objective(s):

        -  To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due
           to MRSA

        -  To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.

        -  To assess the safety of multiple doses of CG400459
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA.

          2. Signs and symptoms should include at least 2 of the following: purulent drainage or
             discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or
             tenderness to palpation

        Exclusion Criteria:

          1. Prior systemic or topical antibacterial therapy

          2. Severe sepsis or refractory shock
A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; rituximab [MabThera/Rituxan]; tocilizumab [RoActemra/Actemra]
Intervention description: iv on days 1 and 15 (Parts 1 and 2); 0.5g iv on days 1 and 15 (Parts 1 and 2); 2mg/kg-8mg/kg iv in Part 1 and selected dose in Part 2, on weeks 4, 8 and 12---Arm 1\n8mg/kg iv on weeks 4,8 and 12 (Parts 1 and 2)--- Arm 2
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in
      combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose
      of methotrexate. In Part 1 of the study, patients will be randomized to receive either
      MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending
      doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm).
      In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera
      0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8
      and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.

      All patients will then be eligible to receive extension treatment withRoActemra every 4
      weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is
      <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-65 years of age;

          -  rheumatoid arthritis, functional status I-III;

          -  SJC>=4 (28 joint count) and TJC>=4 (28 joint count) at screening and baseline;

          -  RF and/or anti-CCP positive;

          -  may have failed up to 1 approved anti-TNF agent (infliximab, etanercept or
             adalimumab);

          -  inadequate response to methotrexate, at a dose of 7.5-25mg weekly for at least 12
             weeks, at a stable dose for past 4 weeks.

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic
             involvement secondary to rheumatoid arthritis;

          -  history of, or current, inflammatory joint disease other than rheumatoid arthritis;

          -  diagnosis of juvenile idiopathic arthritis and/or rheumatoid arthritis before age 16;

          -  significant cardiac or pulmonary disease;

          -  previous treatment with any biologic agent for rheumatoid arthritis (other than
             infliximab, etanercept or adalimumab).
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: BI 201335; BI 201335; Pegylated Interferon-alpha (IFN); Ribavirin (RBV)
Intervention description: BI 201335; BI 201335; Pegylated Interferon-alpha; Ribavirin (RBV)
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI
      201335 at a dose of 120 mg once daily, with a 24-week background of pegylated
      interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with
      hepatitis C virus (HCV) genotype 1
    

Eligibility criteria:

        Inclusion criteria:

          1. Chronic hepatitis C infection of genotype 1

          2. Therapy-naïve to interferon, pegylated interferon, and ribavirin

          3. HCV viral load > 100.000 IU/ml at screening

          4. Liver biopsy or fibroscan within two years prior to screening that provides evidence
             of any degree of fibrosis or cirrhosis

          5. Normal retinal finding on fundoscopy within 6 months prior to Day 1

          6. Age 18 to 70 years

        Exclusion criteria:

          1. HCV of mixed genotype (1/2, 1/3, and 1/4) .

          2. Patients who have been previously treated with at least one dose of any protease
             inhibitor

          3. Evidence of liver disease due to causes other than chronic HCV infection

          4. Positive for HIV-1 or HIV-2 antibodies

          5. Hepatitis B virus (HBV) infection

          6. Decompensated liver disease, or history of decompensated liver disease

          7. Active malignancy or history of malignancy within the last 5 years

          8. History of alcohol or drug abuse (except cannabis) within the past 12 months.

          9. Body Mass Index < 18 or > 35 kg/m2.

         10. Usage of any investigational drugs within 30 days prior to enrolment

         11. Alpha fetoprotein value >100ng/mL at screening;

         12. Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1.

         13. ALT or AST level > 10 x ULN
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: εPA-44
Intervention description: subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis B; HBeAg positive; Therapeutic HBV Vaccine; HBV-specific Cytotoxic T Lymphocyte

Summary:

      The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based)
      treatment in chronic hepatitis B patients and to explore the most effective dosage and
      provide the rational for optimal dosing schedule.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subjects completed the first stage study(0-76 weeks) and willing to willing to
             participate in the trial

          2. Uses effective contraception for subject with child-bearing potential (including
             females and female partners of males)

          3. Understands and signs ICF approved by EC

          4. Willing to comply with the study procedures and complete the study

        Exclusion Criteria:

        1.Any other factors inappropriate for enrollment in the study or study completion in the
        view of the investigator
Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds
Condition: Facial Wrinkles
Intervention: CosmetaLife; Restylane
Intervention description: Dermal filler; Dermal filler
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nasolabial folds; Dermal filler; Injectable dermal filler; Soft tissue augmentation

Summary:

      This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of
      CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as
      nasolabial folds (i.e., smile lines).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients 18 years of age or older

          2. Patients with moderate nasolabial folds (3-4 WSRS scale)

          3. Patients willing to provide written informed consent for their participation in the
             study

          4. Patients willing to abstain from other facial cosmetic procedures through the 12 month
             follow-up visit

        Exclusion Criteria:

          1. Patients with any aesthetic facial therapy within 6 months prior to

          2. Patients with an any reaction to the skin test

          3. Patients with a history of autoimmune disorder, lidocaine reactions, allergy to
             heparin, other severe or chronic allergies

          4. Patients with a current disease state that can effect the immunoresponse, or patients
             on immunosuppressive therapy

          5. Patients with an active infection of any kind, skin disease, connective tissue
             disorder

          6. Patients who are pregnant or lactating

          7. Patients enrolled in another investigational clinical trial
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab (BMS-936558)
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1009.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0
      Grade 3 or higher), treatment-related, select adverse events in subjects with histologically
      confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment
      containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with
      Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects with histologically confirmed malignant melanoma

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):

               -  PS 0 to 1

               -  PS 2

          -  Previously treated unresectable stage III or stage IV melanoma as per the American
             Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status

          -  Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors
             (RECIST 1.1)-defined disease progression

          -  Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2),
             BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or
             extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras
             Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with
             known cKIT mutations are allowed

          -  Patients with CNS metastases are eligible:

               -  if CNS metastases are treated, patients are asymptomatic or neurologically
                  returned to baseline

               -  if they have previously untreated CNS metastases and are asymptomatic

               -  if they have leptomeningeal metastases, are treated and asymptomatic or
                  neurologically returned to baseline with life expectancy > 3 months

          -  Patients with a known history of Grades 3-4 immune-related adverse reactions
             during/after anti-CTLA-4 therapy if all toxicities have resolved at least to Grade 1

        Exclusion Criteria:

          -  Subjects with untreated, active Central Nervous System (CNS) metastases are excluded