bioihbjkbjnl/mcl2 huggingface dataset:
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Condition: Macular Edema Secondary to Central Retinal Vein Occlusion
MeSH terms: Neoplasm Metastasis; Macular Edema; Retinal Vein Occlusion; Edema
Intervention: VEGF Trap-Eye 2.0mg; Sham
Intervention description: Monthly intravitreal injection out to the Week 24 Primary endpoint; Monthly sham intravitreal injection out to Week 24 Primary Endpoint
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Macular edema; Retinal vein occlusion; CRVO; VEGF Trap-Eye; best-corrected visual acuity; Regeneron; COPERNICUS

Summary:

      This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on
      vision function in subjects with macular edema as a consequence of central retinal vein
      occlusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects at least 18 years of age with center-involved macular edema secondary to CRVO
             with mean central retinal thickness ≥ 250 μm on OCT

          -  ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study
             eye

        Exclusion Criteria:

          -  Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib
             sodium,anecortave acetate, bevacizumab, ranibizumab, etc.)

          -  Prior panretinal laser photocoagulation or macular laser photocoagulation in the study
             eye

          -  CRVO disease duration > 9 months from date of diagnosis

          -  Previous use of intraocular corticosteroids in the study eye or use of periocular
             corticosteroids in the study eye within the 3 months prior to Day 1

          -  Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or
             preretinal fibrosis involving the macula in either the study eye or fellow eye
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR); Chlorpromazine
Intervention description: 200 mg or 300 mg, oral, single dose; 50 mg, oral, double dose
Intervention MeSH terms: Chlorpromazine; Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 388.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR); qualified PANSS assessment

Summary:

      The primary objective of this study is to evaluate the efficacy of quetiapine fumarate
      extended-release (XR) used as mono-therapy, administered once daily, in the treatment of
      schizophrenic patient with acute episode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Schizophrenia diagnosis

          -  Provision of written informed consent before initiation of any study

        Exclusion Criteria:

          -  AIDS and hepatitis B

          -  History of seizure disorder

          -  Hospitalisation for schizophrenic more than 1 month immediately before enter into
             study
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
Condition: Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Intervention: Interspinous Spacer device; Interspinous Process Distraction Device
Intervention description: Device: In-Space; Device: X STOP
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of the In-Space
      compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the
      treatment of patients experiencing intermittent neurogenic claudication secondary to moderate
      degenerative lumbar stenosis at one or two lumbar levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 50 years in age

          -  Leg/buttock/groin pain, with or without back pain, that can be completely relieved by
             flexion such as when sitting in a chair.

          -  Zurich Claudication Questionnaire Score ≥ 2.0,

          -  Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis

          -  Has completed at least 6 months conservative therapy

        Exclusion Criteria:

          -  Axial back pain only without leg/buttock/groin pain

          -  Has had any prior lumbar spine surgery at any level

          -  Significant scoliosis, defined as Cobb angle > 10°

          -  Spondylolisthesis > Grade 1 or isthmic spondylolisthesis at affected level

          -  Osteoporosis

          -  Morbid obesity, defined as BMI > 40 kg/m2
Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Ranolazine; Matching placebo
Intervention description: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months.; Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months.
Intervention MeSH terms: Ranolazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Ranolazine

Summary:

      The investigators hypothesize that ranolazine would decrease the incidence of recurrence of
      Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with
      persistent AF who are candidates for electrical cardioversion will be randomized to either
      placebo or ranolazine after successful electrical cardioversion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with persistent atrial fibrillation, aged 21 or older

          -  Duration of atrial fibrillation less than one year

          -  The patient does not have any contraindications for anticoagulation

          -  The patient is willing to participate in the study for a total of 6 months with 3
             outpatient office visits

          -  The patient has provided written informed consent during the screening visit to any
             test or procedure being performed, or medication being changed, for this study.

          -  The patient has no clinically significant abnormal clinical laboratory values, which
             in the investigator's opinion precludes the patient from safely participating in the
             study.

        Exclusion Criteria:

          -  Any contraindication for anticoagulation

          -  New York Heart Association class IV heart failure

          -  Currently taking anti-arrhythmic drugs

          -  Chronic kidney disease (serum creatinine less than 2.5mg/dL) or severe liver
             dysfunction

          -  Pregnancy/nursing

          -  Prolonged QT interval (>500ms)

          -  Taking other medications known to prolong the QT interval

          -  Taking other medications known to affect the metabolism of ranolazine
Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
Condition: Atopic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Cyclosporine Vehicle; Cyclosporine 0.010%
Intervention description: Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.; Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the
      treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The
      study consists of a double-masked phase, and open-labeled phase, and an open-labeled
      maintenance phase. For the first 3 months of the study, patients will receive either masked
      Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients
      may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients
      who are in remission, will be re-randomized to receive either open-labeled Cyclosporine
      0.010% eye drops four times daily or twice daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe
             inflammation of the eye)

          -  Be on stable doses of your current AKC medications for at least 2 weeks

        Exclusion Criteria:

          -  You have used contact lenses within 48 hours of Day 1 or think you may have to wear
             contact lenses during the study

          -  You are pregnant, breastfeeding, or planning to become pregnant during the study

          -  You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical
             pimecrolimus) on or around your eyes including eyelids within 4 weeks
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
Condition: Acute Gouty Arthritis Flares
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: ACZ885; Triamcinolone acetonide 40 mg
Intervention description: canakinumab 150 mg s.c., given on demand upon new flares; Participants received 40 mg intramuscular (IM)
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gouty arthritis

Summary:

      This was an 18-month, multi-center, open-label, clinical extension study. Patients completing
      earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated
      in this combined extension 3 study for any new gouty arthritis flare on demand with one
      subcutaneous (s.c.) injection of canakinumab 150 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed the second extension studies CACZ885H2356E2 or
             CACZ885H2357E2

          -  Patients treated with canakinumab in the core studies or subsequent extensions

        Exclusion Criteria:

        - Pregnant or nursing (lactating) women
Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome--Pediatric Heart Network
Condition: Marfan Syndrome
MeSH terms: Marfan Syndrome; Arachnodactyly; Syndrome
Intervention: Losartan Potassium; Atenolol
Intervention description: Losartan .3 - 1.4 mg/kg; Atenolol .5 - 4 mg/kg
Intervention MeSH terms: Losartan; Atenolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 608.0
Sex: All
Minimum age: 6 Months
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Aortic Root Dissection; Aortic Root Dilation; Pediatric Heart Network

Summary:

      Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this
      condition die because of the associated heart and blood vessel abnormalities. This study will
      compare the effectiveness of two medications, losartan and atenolol, at slowing aortic root
      enlargement in individuals with Marfan syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Marfan syndrome, according to Ghent criteria (more information can be
             found in Appendix D of the protocol)

          -  Aortic root Z-score greater than 3.0

        Exclusion Criteria:

          -  Prior aortic surgery

          -  Aortic root dimension at the sinuses of Valsalva greater than 5 cm

          -  Planned aortic surgery within 6 months of study entry

          -  Aortic dissection

          -  Shprintzen-Goldberg syndrome

          -  Loeys-Dietz syndrome

          -  Therapeutic (i.e., for arrhythmia, ventricular dysfunction, or valve regurgitation)
             rather than prophylactic use of angiotensin-converting enzyme (ACE) inhibitor,
             beta-blocker, or calcium channel blocker

          -  History of angioedema while taking an ACE inhibitor or beta-blocker

          -  Intolerance to losartan or other angiotensin II receptor blocker (ARB) that resulted
             in termination of therapy

          -  Intolerance to atenolol or other beta-blocker that resulted in termination of therapy

          -  Kidney dysfunction (i.e., creatinine greater than the upper limit of age-related
             normal values)

          -  Asthma of sufficient severity to prohibit the use of a beta-blocker

          -  Chronic use of steroids and/or beta-adrenergic agents with exacerbations of asthma
             that are frequent (averaging three or more per year) or severe (requiring
             hospitalization)

          -  Diabetes mellitus

          -  Pregnant or planning to become pregnant within 36 months of study entry

          -  Inability to complete study procedures, including history of poor acoustic windows
             (i.e., inability to obtain accurate measurement of aortic root)
Efficacy and Safety of SPARC0921 in Subjects With Spasticity
Condition: Spasticity
MeSH terms: Muscle Spasticity
Intervention: SPARC0921; Placebo0921
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 392.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: spasticity

Summary:

      The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in
      the treatment of spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age 18 years and older

          -  Able and willing to comply with the protocol, including availability for a scheduled
             clinic visits

          -  Willingness and giving of written informed consent

        Exclusion Criteria:

          -  In relapse or history of unstable course over the prior 30 days prior to the Screening
             Visit

          -  Concomitant neurologic conditions causing spasticity

          -  Has received an investigational drug or device within 30 days that would interfere
             with the study goals prior to the Screening Visit

          -  Unable to comply with study procedures in the opinion of the investigator
A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: Placebo of Aripiprazole; Aripiprazole
Intervention description: administered orally once daily; Flexibly dose administered orally once daily
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Autistic Disorder, children and adolescents; Aripiprazole; Double-blind; Randomized; children and adolescents

Summary:

      The objective of this study is to investigate the efficacy and safety of aripiprazole orally
      administered over a period of 8 weeks in pediatric patients with Autistic Disorder
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder (defined
             in DSM-IV-TR) and also demonstrates behaviors such as tantrums, aggression,
             self-injurious behavior, or a combination of these problems.

          -  Inpatient or outpatient status

          -  Others

        Exclusion Criteria:

          -  The patient is currently diagnosed with another disorder on the autism spectrum in
             DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative
             Disorder, or Fragile-X Syndrome.

          -  Patients who fall under a contraindication listed in the ABILIFY package insert

          -  Others
Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: darbepoetin alfa
Intervention description: Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 358.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CKD; Anemia; correction; darbepoetin alfa

Summary:

      The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin
      alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the
      correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years of age

          -  Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation)

          -  Two consecutive screening Hb values taken at least 7 days apart must each be <10.0
             g/dL

          -  TSAT ≥ 15%

        Exclusion Criteria:

          -  Upper or lower GI bleeding within 6 months before enrolment

          -  ESA use within 12 weeks before enrolment

          -  Uncontrolled hypertension

          -  Systemic haematologic disorders

          -  Prior history within 12 weeks before enrollment of events including: Acute myocardial
             ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart
             failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis,
             thromboembolism.

          -  Grand mal seizure within 6 months prior to enrolment

          -  Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5
             years prior to enrolment.

          -  Red blood cell transfusion within 12 weeks prior to enrolment

          -  Androgen therapy within 8 weeks prior to enrolment

          -  Pregnancy or breast feeding, or inadequate contraception

          -  Currently receiving immunosuppressive therapy
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: Vehicle; Pilocarpine HCl Ophthalmic Solution
Intervention description: Vehicle, one drop in each eye, once daily, for up to 30 days.; Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
Intervention MeSH terms: Ophthalmic Solutions; Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 40 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride
      (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days
      in participants with presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subjective complaints of poor near vision that impact activities of daily living

        Exclusion Criteria:

          -  History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery,
             radial keratotomy, or any intraocular surgery

          -  Use of any topical ophthalmic medications, including artificial tears other than the
             study medications during the study

          -  Use of temporary or permanent punctal plugs or history of punctal cautery in one or
             both eyes

          -  Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial
             dystrophy, guttata, or edema) in either eye that are likely to interfere with visual
             acuity

          -  Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination),
             history of angle-closure glaucoma, or previous iridotomy

          -  Diagnosis of any type of glaucoma or ocular hypertension
Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema
Condition: Otic Eczema
MeSH terms: Eczema
Intervention: DF277; Placebo
Intervention description: Two administrations daily for 7 days; Two administrations daily for 7 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment
      of otic eczema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years or older

          -  Clinical diagnosis of otic eczema suitable for local treatment

        Exclusion Criteria:

          -  Other diseases.