bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: aflibercept; laser photocoagulation
Intervention description: Administered IVT; Transpupillary conventional laser will be administered according to standard local procedures.
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open-Label
Enrollment: 127.0
Sex: All
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the efficacy of aflibercept compared to laser
      in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the
      study are to assess the need for a second treatment modality, to assess the recurrence of ROP
      in the study and to assess the safety and tolerability of aflibercept.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Gestational age at birth ≤ 32 weeks or birth weight ≤1500 g

          -  Patients with treatment-naïve retinopathy of prematurity (ROP) classified according to
             the International Classification for ROP in at least one eye as:

               -  Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or

               -  Zone II Stage 2 plus or 3 plus, or

               -  Aggressive posterior retinopathy of prematurity (AP-ROP)

        Key Exclusion Criteria:

          -  Known or suspected chromosomal abnormality, genetic disorder, or syndrome

          -  Previous exposure to any Intravitreal (IVT) or systemic anti-vascular endothelial
             growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during
             breastfeeding

          -  Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3
             or higher, periventricular leukomalacia, congenital brain lesions significantly
             impairing optic nerve function, severe hydrocephalus with significantly increased
             intracranial pressure)

          -  Pediatric conditions rendering the infant ineligible for study intervention at
             baseline or for repeated blood draws as evaluated by a neonatal intensive care unit
             specialist and a study ophthalmologist

          -  Presence of active ocular infection within 5 days of the first treatment

          -  Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and
             stage 5)

          -  ROP involving only Zone III

        NOTE: Other protocol defined inclusion/exclusion criteria apply.
Natalizumab Re-Initiation of Dosing
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: BG00002 (natalizumab)
Intervention MeSH terms: Natalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 404.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; MS

Summary:

      The primary objectives of this study are to further evaluate the safety of natalizumab
      (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity
      following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab
      from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS)
      therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803
             (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological
             examination and magnetic resonance imaging [MRI] scan)

          -  Considered by the investigator to be free of signs and symptoms suggestive of
             progressive multifocal leukoencephalopathy (PML) based on medical history, physical
             examination, or laboratory testing (results from the Dosing Suspension Safety
             Evaluation from Study C-1808 [NCT000276172] may be used)

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Considered by the investigator to be immunocompromised, based on medical history,
             physical examination, or laboratory testing (results from the Dosing Suspension Safety
             Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment

          -  History of persistent anti-natalizumab antibodies, based upon testing from prior
             natalizumab studies

          -  Other protocol-defined exclusion criteria may apply
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
Condition: Male Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic acid 5 mg iv; Placebo
Intervention description: Zoledronic acid 5 mg iv given once a year.; Placebo intravenous (i.v.) once a year
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1199.0
Sex: Male
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoporosis; males; vertebral fractures; clinical fractures; bone mineral density; bone biomarkers; zoledronic acid

Summary:

      This study will investigate if the drug zoledronic acid given once yearly is safe and has
      beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with
      osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

        • Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone
        mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the
        vertebrae

        Exclusion Criteria:

          -  Low Vitamin D

          -  Renal insufficiency

          -  Previous treatment with certain anti-osteoporotic therapies (except after certain
             washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium
             fluoride, strontium ranelate,

          -  Previous treatment with testosterone, anabolic steroids or growth hormone

          -  Chronic use of systemic corticosteroids (oral or i.v.) within the last year

          -  History of any cancer or metastases within the last 5 years

          -  History of brittle bone disease, multiple myeloma, or Paget's disease, or any other
             metabolic bone disease, except osteoporosis

          -  Bilateral hip replacements

        Other protocol-defined inclusion/exclusion criteria may apply
Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)
Condition: Juvenile Psoriatic Arthritis; Enthesitis-related Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Enthesopathy; Arthritis, Juvenile
Intervention: secukinumab; placebo
Intervention description: secukinumab is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.; Matched placebo to AIN457 for use in the double blind Treatment Period 2
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: JIA; JPsA; ERA; Secukinumab; ILAR; Arthritis

Summary:

      This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to
      investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic
      Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related
      Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period)
      consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a
      randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment
      Period 2
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic
             arthritis (JPsA) according to the International League of Associations for
             Rheumatology (ILAR) classification criteria of at least 6 months duration.

          2. Active disease (ERA or JPsA) defined as having both:

               -  at least 3 active joints

               -  at least 1 site of active enthesitis at baseline or documented by history.

          3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal
             anti-inflammatory drugs(NSAID)

          4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying
             antirheumatic drugs (DMARD)

          5. No concomitant use of second line agents such as disease-modifying and/or
             immunosuppressive drugs.

        Exclusion Criteria:

          1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.

          2. Patients who have ever received biologic immunomodulating agents

          3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA
             patients only).

          4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled
             uveitis.

        Other protocol-defined inclusion/exclusion criteria apply.
STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: primary PCI; enoxaparin; catheterisation; tenecteplase; clopidogrel
Intervention description: Standard primary PCI; Adjunctive treatment; Routine or rescue coronary intervention; Single, weight-adjusted i.v. bolus of tenecteplase; Adjunctive treatment
Intervention MeSH terms: Enoxaparin; Tenecteplase; Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1899.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims at evaluating, in a proof of concept approach, the outcome of patients
      presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in
      either a pre-hospital setting or community hospital emergency room without a PCI facility.
      Following randomisation a strategy of early tenecteplase and additional antiplatelet and
      antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary
      intervention as appropriate (or by rescue coronary intervention if required) in Group A will
      be compared to primary PCI performed according to local standards in Group B.

      The study is exploratory in nature and will examine this medical question. The efficacy and
      safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before
      30 days following randomisation will be evaluated.

      All clinical endpoints of main interest will be assessed as single or composite endpoints for
      evaluation of the trial objective. All statistical tests are of exploratory nature based on
      descriptive p-values for formal statistical hypotheses generation.
    

Eligibility criteria:

        Inclusion criteria:

          1. Age equal or greater than 18 years

          2. Onset of symptoms < 3 hours prior to randomisation 3.12-lead ECG indicative of an
             acute STEMI

        4.Informed consent received

        Exclusion criteria:

        Medical history, procedures, medication administration or the presence of factors that
        would in general predispose to bleeding events and/or the inability to evaluate the study
        primary endpoint
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: Botulinum Toxins, Type A; Placebos
Intervention description: Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: glabellar lines, frown lines

Summary:

      This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to
      severe frown lines.
    

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 One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
Condition: Asthma; Diabetes Mellitus
MeSH terms: Asthma; Diabetes Mellitus
Intervention: Inhaled Insulin; Subcutaneous Insulin
Intervention description: Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.; Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics
      with Asthma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin

          -  Mild intermittent or mild to moderate persistent asthma

        Exclusion Criteria:

          -  Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking
Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: onabotulinumtoxinA; normal saline
Intervention description: OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).; Normal saline (placebo) injected into the detrusor at Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 557.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A
      (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary
      incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months

          -  Inadequate response or limiting side effects with anticholinergics for the treatment
             of OAB

        Exclusion Criteria:

          -  Overactive Bladder caused by neurological condition

          -  Patient has predominance of stress incontinence

          -  History or evidence of pelvic or urological abnormality
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Condition: Anemia
MeSH terms: Anemia
Intervention: Darbepoetin alfa; methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.; RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of intravenous (iv) Mircera given as
      maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who
      were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2
      years and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  chronic renal anemia;

          -  on dialysis therapy for at least 12 weeks before screening;

          -  receiving darbepoetin alfa iv for at least 8 weeks before screening.

        Exclusion Criteria:

          -  women who are pregnant, breastfeeding or using unreliable birth control methods;

          -  administration of another investigational drug within 4 weeks before screening, or
             during the study period.
Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
Condition: Chronic Obstructive Pulmonary Disease, COPD; Low Peak Inspiratory Flow Rate (PIFR)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Intervention: Revefenacin; Spiriva Handihaler®; Placebo for Revefenacin; Placebo for Spiriva Handihaler®
Intervention description: Revefenacin administered via nebulization.; Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.; Placebo administered as double blind, double dummy via nebulization.; Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD; Low Peak Inspiratory Flow Rate (PIFR)

Summary:

      This study is a randomized, double-blind, double-dummy, parallel group study to compare once
      daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung
      function in subjects with COPD and a Low Peak Inspiratory Flow Rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female subject 40 years of age or older with a diagnosis of COPD.

          -  Subject has a current or past cigarette smoking history (or equivalent for cigar or
             pipe smoking history) of at least 10 pack-years.

          -  Subject is willing and able to provide signed and dated written informed consent to
             participate prior to initiation of any study related procedures.

        Exclusion Criteria:

          -  Subject has a concurrent disease or condition that, in the opinion of the
             investigator, would interfere with continued study participation or confound the
             evaluation of safety and tolerability of the study drug.

          -  Subject has a history of reactions or hypersensitivity to inhaled or nebulized
             anticholinergics.

          -  Subject suffers from any medical condition that would preclude the use of inhaled
             anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic
             hyperplasia, bladder neck obstruction, or urinary retention.