bioihbjkbjnl/mcl2 huggingface dataset:
To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Rituxan; CT-P10; Cyclophosphamide; Vincristine; Prednisone
Intervention MeSH terms: Prednisone; Prednisolone; Cyclophosphamide; Rituximab; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Follicular Lymphoma

Summary:

      This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double
      blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate
      equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of
      CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients
      with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is male or female older than 18 years.

          2. Patient has histologically confirmed FL according to the World Health Organization
             2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.

          3. Patient has at least 1 measurable tumour mass that has not previously been irradiated,
             and the mass must be:

               -  greater than 1.5 cm in the longest dimension or

               -  between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the
                  shortest axis

          4. Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue
             obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central
             independent reviewer to detect pathological type.)

          5. Patient has Ann Arbor stage III or IV disease.

        Exclusion Criteria:

          1. Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or
             vincristine.

          2. Patient has allergies or hypersensitivity to murine, chimeric, human or humanised
             proteins, cyclophosphamide, vincristine, or prednisone.

          3. Patient has evidence of histological transformation to high-grade or diffuse large
             B-cell lymphoma.

          4. Patient has known central nervous system involvement.

          5. Patient has received previous treatment for NHL:

               -  Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or
                  surgery (except previous biopsy)

               -  All doses of corticoid therapy for treatment of NHL

               -  Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with
                  prednisone >20 mg per day for the treatment for any purpose
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: PL2200 Aspirin Capsules; Enteric-coated aspirin caplets
Intervention description: 325 mg aspirin; once per day for 10 days; 325 mg aspirin; once per day for 10 days
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 21 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This study will determine if aspirin from PL2200, an investigational product, gets into the
      blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to
      prevent blood clots as effectively as enteric coated aspirin, when administered to patients
      with diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-Insulin-Dependent Diabetes Mellitus

          -  Adults 21 to 79 years, inclusive

          -  Body mass index between 30 and 40 kg/m2, inclusive

        Exclusion Criteria:

          -  Currently prescribed aspirin or anti-coagulants

          -  Contraindications to aspirin

          -  Significant disease history or active disease other than Non-Insulin-Dependent
             Diabetes Mellitus

          -  Patient requires insulin
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
Condition: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder
MeSH terms: Neuromyelitis Optica
Intervention: eculizumab
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Long-term safety study; Extension trial; Eculizumab; Neuromyelitis Optica Spectrum Disorder; Devic's disease; Transverse Myelitis; Optic Neuritis; Relapse; NMO-IgG; CNS Autoimmune Disorders; Demyelinating Disorders

Summary:

      The purpose of this study is to determine whether eculizumab long-term use is safe and
      effective in patients with relapsing NMO.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Patient completed the ECU-NMO-301 trial

          2. Patient has given written informed consent

        Key Exclusion Criteria:

          1. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to
             trial drug

          2. Female patients who are pregnant, breastfeeding, or intend to conceive during the
             course of the trial
Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: acoustical pulse energy (extracorporeal shockwave); Sham
Intervention description: Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.; Non-energized (inactive - Sham) application + standard of care
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the safety and effectiveness of the dermaPACE Device
      to sham application, when administered in conjunction with standard treatments used in the
      treatment of DFUs.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Male or female ≥ 18 years of age

          -  Diabetes mellitus

          -  One or more chronic foot ulcers (only one will be treated) that are located in the
             ankle area or below that has persisted a minimum of 30 days prior to the Screening
             visit

          -  HbA1c ≤ 12%

          -  Diabetic Foot Ulcers ≥ 1 cm2 and ≤ 16 cm2

          -  Ulcer Grade I or II, Stage A according to the University of Texas Diabetic Wound
             Classification system

          -  Ankle Brachial Index (ABI) ≥ 0.7 and ≤ 1.2, OR toe pressure > 50 mmHg, OR tcPO2> 40
             mmHg.

        Major Exclusion Criteria:

          -  Subject is morbidly obese (Body Mass Index ≥ 40)

          -  Subjects on dialysis

          -  Diagnosis of foot ulcer involving osteomyelitis

          -  Has evidence of prior ulcer in the same area

          -  Multiple diabetic foot ulcers on the foot that either are connected by fistulas or are
             within 5 cm of the target ulcer

          -  Subject's foot ulcer intended for study application has decreased in volume by 50% or
             more at the end of the two-week Run-in period as compared to the Screening visit.
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Nalmefene hydrochloride
Intervention MeSH terms: Nalmefene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with
      alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed Study 339-14-001

          -  Patients who have signed the informed consent form for Study 339-14-002

        Exclusion Criteria:

          -  The patient has a clinically significant unstable illness (eg, complication of New
             York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal
             function disorder with estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73
             m2, hepatic failure, and neoplastic disorder)

          -  The patient has a clinically significant abnormal electrocardiogram (ECG) which is
             inappropriate for the participation in the trial in the opinion of the investigator or
             subinvestigator
Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib; Ofatumumab
Intervention description: 150 mg tablets administered orally twice daily; Administered intravenously
Intervention MeSH terms: Ofatumumab; Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLL; Chronic Lymphocytic Leukemia; GS-1101; CAL-101; Ofatumumab

Summary:

      The primary objective of this study is to evaluate the effect of the addition of idelalisib
      to ofatumumab on progression-free survival (PFS) in participants with previously treated
      chronic lymphocytic leukemia (CLL).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adults with previously treated recurrent CLL who have measurable lymphadenopathy

          -  Require therapy for CLL

          -  Have experienced CLL progression < 24 months since the completion of the last prior
             therapy

          -  Have disease that is not refractory to ofatumumab

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: Botulinum Toxins, Type A
Intervention description: Intramuscular Injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2691.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glabellar lines, frown lines

Summary:

      This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of
      moderate to severe glabellar lines following single and repeat administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent including authorization to release health information

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the
             Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient
             Frown Wrinkle Severity (PFWS) scale

          -  Willing and able to follow all trial procedures, attend all scheduled visits, and
             successfully complete the trial

        Exclusion Criteria:

          -  Any neurological condition that may place the subject at increased risk with exposure
             to botulinum toxin type A, including peripheral motor neuropathic diseases such as
             amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional
             disorders such as Lambert-Eaton syndrome and myasthenia gravis

          -  Active skin disease, infections or inflammation at the injection sites

          -  Plan to receive botulinum toxin type A anywhere in the face through the duration of
             the study

          -  History of allergy or sensitivity to any botulinum toxin preparations or to any
             component of the test article

          -  Current enrollment in an investigational drug or device trial or participation in such
             a trial within the last 30 days prior to screening through end of trial
A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
Condition: HIV Infection; Infection, Human Immunodeficiency Virus
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Half-boosted Fosamprenavir; Full Boosted Fosamprenavir
Intervention description: Once daily, reduced dose ritonavir-boosted fosamprenavir; Full ritonavir-boosted fosamprenavir
Intervention MeSH terms: Ritonavir; Fosamprenavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1 LEXIVA Ritonavir Once-daily

Summary:

      This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted
      fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen
      administered either twice-daily or once-daily.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects with HIV-1 infection.

          -  Are willing and able to understand and provide written consent prior to participation
             in this study.

        Exclusion criteria:

          -  Are pregnant or breastfeeding.

          -  Have an active AIDS condition, pancreatitis, poor kidney function, or clinically
             relevant hepatitis.

          -  Have certain medical conditions that may make participation unsafe.

          -  Take medication that may interact with the study medication.

          -  Have a history of allergy to any of the study drugs or any excipients therein.

          -  Other inclusion/exclusion criteria to be evaluated by the physician.
Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: 0.5 mg ranibizumab
Intervention description: Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age related; Macular; sub retinal fluid; Age related Macular degeneration

Summary:

      TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be
      randomized 1:2 to "monthly" (control arm) or "treat and extend" protocol (comparator arm)
      respectively. TREX assess the safety, tolerability and efficacy of intravitreal injections
      (IVT) of 0.5mg ranibizumab given monthly for up to 100 weeks followed by pro re nata (PRN)
      treatment for 56 weeks compared to a Treat and Extend protocol for 156 weeks in patients with
      wet age-related macular degeneration (AMD). Subjects treated in a treat and extend protocol
      receive 3 consecutive IVT 0.5 mg ranibizumab (visits 2, 4 and 5). Starting at week 8, if a
      subject has achieved a "dry" macula; signs of active exudation have resolved will begin a
      Treat and Extend protocol (visits lengthened by 2 week intervals every visit a dry macular is
      maintained). At the beginning of the 104-week endpoint subjects initially randomized to the
      TREX cohort will transition to PRN re-treatment when there is no exudative disease activity
      at the 12-week interval.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 50 years

          -  Ability and willingness to return for all scheduled visits and assessments

          -  Any CNVM lesion (Occult, Minimally Classic or Classic) (i.e., leakage on fluorescein
             angiography or subretinal, intraretinal activity on SDOCT) secondary to age-related
             macular degeneration.

        Best corrected visual acuity in the study eye, using ETDRS testing, between 20/32 and
        20/400 (Snellen equivalent), inclusive.

        -The total area of subretinal hemorrhage and fibrosis must comprise less than 50% of the
        total lesion. Clear ocular media and adequate pupillary dilation to permit good quality
        fundus imaging.

        Exclusion Criteria:

          -  Subretinal hemorrhage in the study eye that involves the center of the fovea, if the
             size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc
             area (2.54 mm2) in size

          -  Subfoveal fibrosis or atrophy in the study eye

          -  CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or
             pathologic myopia
Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia
Condition: Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Intervention: Prednisone; Dexamethasone
Intervention description: Continuous daily therapy; 4-day pulses every 3 weeks
Intervention MeSH terms: Dexamethasone; Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1
      between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and
      six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary
      endpoint is duration of remission defined as platelets ≥50/nl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First episode of ITP

        Exclusion Criteria:

          -  Pregnancy

          -  Glucocorticoid intolerance
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Vilazodone; Vilazodone
Intervention description: Dose matched placebo tablets, once per day, oral administration.; Vilazodone tablets, 15 mg per day, oral administration; Vilazodone tablets, 30 mg once per day, oral administration
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 529.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      relative to placebo in adolescent outpatients (12-17) with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female outpatients between 12-17 years of age

          -  Primary diagnosis of major depressive disorder (MDD)

          -  Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater

          -  Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

        Exclusion Criteria:

          -  Current (past 3 months) principal Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder
             other than major depressive disorder (MDD) that is the primary focus of treatment.

          -  History of suicidal behavior, or requires precaution against suicide

          -  Not generally healthy medical condition

          -  Seizure disorder
A Study of ProQuad™ in Healthy Children in Korea (V221-023)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Intervention: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™); M-M-R™ II and Varivax™
Intervention description: Single administration of 0.5 mL subcutaneous injection; Single administration of 0.5 mL subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Measles; Mumps; Rubella; Varicella

Summary:

      This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™
      with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested
      is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after
      vaccination with ProQuad™ will be non-inferior to the antibody response rates after
      vaccination with concomitant M-M-R™ II and Varivax™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is in good health

          -  Subject has a negative clinical history for measles, mumps, rubella, varicella and
             zoster

        Exclusion Criteria:

          -  Subject has previously received measles, mumps, rubella and/or varicella vaccine,
             either alone or in any combination

          -  Subject has any congenital or acquired immune deficiency, neoplastic disease or
             depressed immunity

          -  Subject has a history of seizure disorder

          -  Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4
             weeks

          -  Subject has received an inactivated vaccine within the past 14 days

          -  Subject has received a live vaccine within the past 30 days

          -  Subject has received immune globulin within the past 5 months

          -  Subject has a recent history of fever (within the last 72 hours)