bioihbjkbjnl/mcl2 huggingface dataset:
A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Lyophilized S95014
Intervention description: Each patient was administrated, over 1 to 2 hours, every 2 weeks Lyophilized S95014 intravenously at the dose of 1000, 2000 or 2500U/m2, as per investigator's judgement.
In total, 9 infusions of lyophilized S95014 were administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients received other backbone chemotherapy agents as per ALL-MB 2015.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia; Phase II; Oncology / Haematology; Continued treatment; Pegaspargase; Lyophilized pegaspargase; Roll-over study / extension study

Summary:

      The purpose of this study is to provide treatment with lyophilized S95014 in pediatric
      patients with ALL who completed the CL2-95014-002 study during the induction phase and who
      are clinically benefitting from S95014 without major toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient who completed the CL2-95014-002 study

          -  Patient currently receiving clinical benefit from previous treatment with S95014 as
             per investigator's judgment

          -  Signed informed consent and assent, when appropriate

          -  Highly effective contraception method

        Non-inclusion Criteria:

          -  Unlikely to cooperate in the study

          -  Pregnant and lactating women

          -  Participant already enrolled in the study (informed consent signed)

          -  Prior surgery or bone marrow transplant related to the studied disease

          -  History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs

          -  Psychiatric illness/social situation that would limit compliance with study
             requirements

          -  Group "E" and "T-HR" patients according to ALL-MB 2015 protocol classification

          -  Major safety issue due to previous S95014 administration (e.g. non recovery of safety
             parameters, serious hypersensitivity, serious pancreatitis, serious haemorrhage,
             serious thromboembolic event)

          -  Significant laboratory abnormality or uncontrolled intercurrent illness (e.g.
             life-threatening acute tumor lysis syndrome, symptomatic congestive heart failure,
             cardiac arrhythmia, severe or uncontrolled active acute infection) likely to
             jeopardize the patients' safety or to interfere with the conduct of the study, in the
             investigator's opinion
Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Fovista® (anti-PDGF BB) plus anti-VEGF
Intervention MeSH terms: Becaplermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; Choroidal neovascularization; Fovista®; E10030; Avastin®; Eylea®

Summary:

      The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered
      in combination with anti-VEGF therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  All fluorescein angiographic subtypes with presence of active choroidal
             neovascularization

        Exclusion Criteria:

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication

          -  Subjects with subfoveal scar or subfoveal atrophy

          -  Any ocular or periocular infection in the past twelve (12) weeks

          -  History of any of the following conditions or procedures in the study eye:
             Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.
             trabeculectomy), glaucoma drainage device, corneal transplant
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Placebo; LY3041658
Intervention description: Administered IV; Administered IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3041658 is effective in participants
      with moderate-to-severe hidradenitis suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of HS for at least 6 months

          -  Have HS lesions in at least 2 different anatomic areas

          -  Have inadequate response or intolerance to a 28 day course of oral antibiotics

          -  Have a total count of abscesses and inflammatory nodules greater than or equal to 4

          -  Agree to use a topical antiseptic daily

          -  Agree to stop using topical antibiotics during the study. In certain cases, oral
             antibiotics will be allowed

        Exclusion Criteria:

          -  Have more than 20 draining fistulae

          -  Have received any biologic medication (adalimumab, etc.) for the treatment of HS

          -  Plan to use oral opioids for HS-related pain during the study

          -  Uncontrolled depression or suicidal thoughts
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
Condition: Chronic Traumatic Encephalopathy
MeSH terms: Brain Diseases; Brain Injuries, Traumatic; Chronic Traumatic Encephalopathy
Intervention: florbetapir F 18; Flortaucipir F18
Intervention description: 370 megabecquerel (MBq) IV single-dose; 370 megabecquerel (MBq) IV single-dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Male
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will explore the use of flortaucipir as a biomarker for chronic traumatic
      encephalopathy (CTE) and examine the relationship between clinical presentation and tau
      deposition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects consented and currently enrolled in the Diagnosing and Evaluating
             Traumatic Encephalopathy Using Clinical Tests (DETECT) or the Long-Term Consequences
             of Repetitive Brain Injury in Athletes study protocols

          -  Can tolerate up to two PET imaging sessions

          -  Have the ability to provide informed consent for study procedures

        Exclusion Criteria:

          -  Claustrophobia

          -  Current clinically significant cardiovascular disease or clinically significant
             abnormalities on screening ECG

          -  History of risk factors for Torsades de Pointes or are taking drugs known to cause
             QT-prolongation

          -  Current clinically significant infectious disease, endocrine or metabolic disease,
             pulmonary, renal or hepatic impairment, or cancer that the investigator believes would
             affect study participation or scan results

          -  Have had a non-study related radiopharmaceutical imaging or treatment within 7 days
             prior to study PET imaging sessions
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
Condition: Acromegaly; Pituitary Gigantism
MeSH terms: Acromegaly; Gigantism; Pituitary Diseases
Intervention: Pasireotide LAR
Intervention description: Intramuscular administration of pasireotide LAR was repeated every month (1 month = 28 days) for 12 months in core phase. It was permitted to increase the dose up to 60 mg in a patient showing the following biochemical test results after 3 and 6 months of study treatment: mean GH levels ≥2.5 µg/L and/or IGF-1 > ULN. In the event of any problem with tolerability, it was permitted to reduce the next lower dosage level at any time.
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SOM230; Pasireotide; acromegaly; Phase II; growth disorder; gigantism; Pituitary adenoma; pituitary gigantism

Summary:

      To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in
      Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to
      assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to <
      2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with medication naïve acromegaly or pituitary gigantism

          -  Patients with inadequately controlled acromegaly or pituitary gigantism

        Exclusion Criteria:

          -  Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c >8%

          -  Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,
             sustained ventricular tachycardia, ventricular fibrillation, clinically significant
             bradycardia, advanced heart block or a history of acute myocardial infarction within
             the six months preceding enrollment

          -  Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF
             > 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT
             syndrome, or patients receiving a concomitant medication known to prolong QT interval
Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma
Condition: Non-Hodgkins Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Rituximab
Intervention description: 375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-Hodgkins; lymphoma; stem cell transplant

Summary:

      Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell
      transplantation will help patients get rid of their lymphoma cells from the bone marrow and
      stem cell collections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with biopsy-proven refractory CD20+ (cluster of differentiation antigen 20)
             Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 (complete
             remission 1) or later.

          -  Patients must be transplant eligible per KUCC BMT SOP (Kansas University Cancer Center
             Bone Marrow Transplant Standard Operation Procedures) with chemo-sensitive/marrow
             negative disease.

          -  Patients planning to harvest and hold may also be included as long as above criteria
             are met.

        Exclusion Criteria:

          -  Pregnancy

          -  Zubrod performance status greater than 2

          -  Life expectancy is severely limited by concomitant illness.

          -  Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation

          -  Symptomatic pulmonary disease precluding transplantation

          -  Serum creatinine greater than 1.8 mg/dL

          -  Serum bilirubin greater than 2 X upper limit of normal, SGPT (serum glutamate pyruvate
             transaminase) greater than 3 times upper limit of normal

          -  Evidence of chronic active hepatitis or cirrhosis

          -  Unable to sign informed consent.

          -  Allergy to Rituximab
STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: vismodegib
Intervention description: 150 mg once daily until disease progression or unacceptable toxicity
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1232.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm, open-label, multi-center study will evaluate the safety and efficacy of
      vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma.
      Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or
      unacceptable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Metastatic or locally advanced basal cell carcinoma considered inoperable or that
             surgery is contraindicated and radiotherapy is contraindicated or inappropriate

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

        Exclusion Criteria:

          -  Concurrent anti-tumor therapy

          -  Completion of the most recent anti-tumor therapy less than 21 days prior to the
             initiation of treatment

          -  Uncontrolled medical illness
A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: CSL112; Placebo
Intervention description: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.; 0.9% weight/volume sodium chloride solution (ie, normal saline)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1267.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter randomized, double-blind, placebo-controlled, parallel-group,
      dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of
      multiple dose administration of two dose levels of CSL112 compared with placebo in subjects
      with acute myocardial infarction (AMI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women, at least 18 years of age, with evidence of myocardial necrosis in a
             clinical setting consistent with a type I (spontaneous) acute myocardial infarction
             (AMI), in the last week.

        Exclusion Criteria:

          -  Ongoing hemodynamic instability

          -  Evidence of hepatobiliary disease

          -  Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or
             severe renal impairment or if subject is receiving dialysis

          -  Evidence of unstable renal function

          -  History of acute kidney injury after previous exposure to an intravenous contrast
             agent.

          -  Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its
             components

          -  Other severe comorbid condition, concurrent medication, or other issue that renders
             the subject unsuitable for participation in the study
A 48-Week, Open Label, Study to Evaluate the Efficacy and Safety of AMONDYS 45, EXONDYS 51, VYONDYS 53 in Subjects With DuchenneMuscular Dystrophy Carrying Eligible DMD Duplications.
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Amondys 45; Exondys 51; Vyondys 53
Intervention description: This drug is used to target skipping of exon 45 of the dystrophin gene.; This drug is used to target skipping of exon 51 of the dystrophin gene.; This drug is used to target skipping of exon 53 of the dystrophin gene.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 6 Months
Healthy volunteers: No
Keywords: DMD; Exon Skipping

Summary:

      This is an 48-week open-label study to determine the efficacy and safety of AMONDYS 45,
      EXONDYS 51, VYONDYS 53 for the treatment of boys with duchenne muscular dystrophy who have a
      single exon duplication of either exon 45, 51 or 53, respectively. There will be weekly
      infusions and two muscle biopsies at baseline and at month 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a male with DMD and has an out-of-frame duplication of either exon 45, 51, or 53,
             with a normal copy number of all other DMD exons.

          -  Is above age 6 months of age.

          -  Has sufficient muscle mass in a pair of bilateral muscles that will allow for pre- and
             post-treatment muscle biopsies per PI discretion.

          -  If the subject is ambulant and 4 years old or greater and has been on a stable dose or
             dose equivalent of oral corticosteroids for at least 12 weeks prior to Week 1 the dose
             is expected to remain constant (except for modifications to accommodate changes in
             weight) throughout the study.

        Exclusion Criteria:

          -  Any additional missing exon for DMD that cannot be treated with study drugs.

        Other inclusion/exclusion criteria apply
Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: SYN111; Placebo
Intervention description: 500 mg for 1 week followed by 1000 mg for 7 weeks; 0 mg tablets
Intervention MeSH terms: Rufinamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: GAD

Summary:

      A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to
      Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized
      Anxiety Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient 18-65

          -  Meet Diagnostic and Statistical Manual,(DSM) IV criteria for GAD

          -  Have moderate to severe anxiety

          -  Sign IRB (Institutional Review Board) approved consent and can comply with visits and
             procedures

          -  Women of childbearing potential must use acceptable method of contraception

        Exclusion Criteria:

          -  Have diagnosis of adjustment disorder or anxiety disorder Not otherwise specified
             (NOS)

          -  Have diagnosis of specific phobia

          -  Have diagnosis of antisocial personality disorder or other Axis II Disorder

          -  Have diagnosis of substance abuse disorder within 3 months of study entry

          -  Have diagnosis of major depressive disorder or panic disorder within 6 months of study
             entry

          -  Have diagnosis of PTSD, eating disorder substance dependence disorder within 12 months
             of study entry

          -  Have diagnosis anytime during lifetime of schizophrenia or other psychotic disorder,
             bipolar mood disorder, Obsessive-Compulsive Disorder (OCD), psychosurgery

          -  Require medication to treat GAD other than study medication

          -  Failed to show improvement with past treatment for GAD

          -  Excessively consume caffeine

          -  Are receiving treatment with prohibited medications

          -  Uncontrolled thyroid condition

          -  Positive urine drug screen

          -  Obese

          -  Clinically significant ECG finding

          -  Participating in other clinical trial

          -  Clinically significant out of range lab value

          -  Past exposure to rufinamide

          -  Pregnant or nursing females
ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
Condition: Wet Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Zimura; Lucentis
Intervention description: Zimura in combination with Lucentis; Zimura in combination with Lucentis
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Zimura; ARC1905; Lucentis; ranibizumab; Wet AMD; avacincaptad pegol; complement factor C5 inhibitor

Summary:

      To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in
      combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related
      macular degeneration (NVAMD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active subfoveal NVAMD

        Exclusion Criteria:

          -  History or evidence of severe cardiac disease

          -  Any major surgical procedure within one month of trial entry

          -  Subjects with a clinically significant laboratory value

          -  Any treatment with an investigational agent in the past 60 days for any condition

          -  Women who are pregnant or nursing

          -  Known serious allergies to the fluorescein dye used in angiography, povidone iodine,
             to the components of the ranibizumab formulation, or to the components of the Zimura
             formulation

          -  Any prior treatment for AMD other than oral supplements of vitamins and minerals