bioihbjkbjnl/mcl2 huggingface dataset:
A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111
Condition: Choroideremia
MeSH terms: Choroideremia
Intervention: BIIB111
Intervention description: Administered as specified in the treatment arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NightstaRx; NSR-REP1; CHM; Gene Therapy; AAV; REP1; Timrepigene Emparvovec

Summary:

      The objective of the study is to evaluate the safety of bilateral, sequential sub-retinal
      administration of a single dose of BIIB111 in adult male participants with Choroideremia
      (CHM).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Are willing and able to give informed consent for participation in the study to have
             both eyes treated.

          2. Have documentation of a genetically-confirmed diagnosis of CHM.

          3. Have active disease clinically visible within the macular region of both eyes.

          4. Have a BCVA of ≥34 ETDRS letters (20/200 or better Snellen acuity) in both eyes, or in
             the untreated eye, if the other eye was previously treated with BIIB111*

             *If previously treated with BIIB111 in an antecedent study, participants may be
             eligible for participation following Sponsor approval.

          5. For participants who received treatment with BIIB111 in an antecedent study, have
             biological samples available to complete an adequate immunology profile.

        Key Exclusion Criteria:

          1. Have a history of amblyopia or inflammatory disorder in either eye.

          2. Are unwilling to use barrier contraception methods or abstain from sexual intercourse
             for a period of 3 months following treatment with BIIB111 in either eye.

          3. Have had previous intraocular surgery performed within 3 months of the Screening Visit
             in either eye.

          4. Have any other significant ocular or non-ocular disease/disorder which, in the opinion
             of the investigator, may either put the participants at risk because of participation
             in the study, or may influence the results of the study or the participant's ability
             to participate in the study. This includes but is not limited to a potential
             participants:

               -  with a contraindication to oral corticosteroid (e.g., prednisolone/prednisone)

               -  with clinically significant cataract in either eye

               -  who, in the clinical opinion of the Investigator, is not an appropriate candidate
                  for sub-retinal surgery.

          5. Have participated in another research study involving an investigational product in
             the past 12 weeks or received a gene/cell-based therapy at any time previously, except
             if treated within an antecedent study with BIIB111.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga-PSMA
Intervention description: Positron Emission Tomography/Computed Tomography (PET/CT) imaging with 68Ga-PSMA:
68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to find out whether imaging of the prostate with a new molecule
      called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of
      patients to be useful to find recurring prostate cancer following initial cancer treatment.
      This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers
      that would be considered in need for treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent MRI of the prostate has resulted in at least one lesion suspected to represent
             prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)

          -  Treating physician has already indicated a need for a prostate biopsy procedure.

          -  Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or
             b) single or multiple negative prior biopsies.

        Exclusion Criteria:

          -  Prostate biopsy within 12 weeks before enrollment

          -  Acute prostatitis within the last 6 months

          -  Current non-urologic bacterial infection requiring active treatment with antibiotics

          -  Active other malignancy (except basal cell or squamous cell skin cancer) within the
             last 2 years

          -  Body weight greater than 350 lbs (158 Kg)

          -  Inability or unwillingness to receive a prostate biopsy procedure

          -  Unable to lie flat, still, or tolerate a PET/CT scan

          -  Unable to provide own consent

          -  Concurrent severe and/or uncontrolled and/or unstable medical disease other than
             prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial
             infarction within 6 months prior to study participation, unstable and uncontrolled
             hypertension, acute renal failure of any intensity, chronic renal or hepatic disease,
             severe pulmonary disease).
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Intervention: Dapagliflozin; Placebo
Intervention description: Tablets, Oral, 5 mg, once daily, 12 weeks; Tablets, Oral, 0 mg, Once daily, 12 weeks
Intervention MeSH terms: Dapagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0
             and ≤ 10.0% at the enrollment visit

          -  Subjects should have been receiving either metformin therapy OR metformin therapy AND
             one insulin secretagogue for at least 12 weeks prior to enrollment

          -  C-peptide ≥ 1.0 ng/ml (0.34 nmol/l)

          -  BMI ≤ 45.0 kg/m2

        Exclusion Criteria:

          -  Urine albumin to creatinine ratio (UACR) > 1,800 mg/g (203.4 mg/mmol/Cr)

          -  Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN)

          -  Alanine aminotransferase (ALT) > 3X ULN

          -  Serum Total Bilirubin > 2 mg/dL (34.2 μmol/l)

          -  Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124
             μmol/l) for women

          -  Currently unstable or serious cardiovascular, renal, hepatic, hematological,
             oncological, endocrine, psychiatric, or rheumatic diseases
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
Condition: Influenza Caused by the Novel Influenza A (H1N1) Virus
MeSH terms: Influenza, Human
Intervention: CSL425; CSL425
Intervention description: CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free; CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 370.0
Sex: All
Minimum age: 6 Months
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for
      eliciting an immune response to H1N1 influenza in healthy children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged >= 6 months to < 9 years at the time of the first study
             vaccination.

          -  For children < 3 years of age at the time of first vaccination, born at or after 36
             weeks of gestation.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to
             eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study
             Vaccine.
Hyperpolarized 13C Pyruvate MRI for Treatment Response Assessment in Pancreatic Ductal Adenocarcinoma
Condition: Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Hyperpolarized Carbon C 13 Pyruvate; Magnetic Resonance Imaging (MRI)
Intervention description: Given IV prior to imaging; Undergo MRI
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperpolarized 13C Pyruvate; Pancreatic Cancer

Summary:

      This phase II trial investigates whether magnetic resonance imaging (MRI) using
      hyperpolarized carbon-13 (13C) pyruvate can be useful for evaluating early treatment response
      in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally
      advanced) or spread to other places in the body (metastatic). Hyperpolarized 13C pyruvate is
      different from standard clinical MRI contrast (e.g. gadolinium) in that it provides
      information on how a tumor processes nutrients. MRI is used to see tumor uptake and breakdown
      of hyperpolarized carbon-13 pyruvate molecules, which can tell how the tumor processes
      nutrients. Hyperpolarized 13C pyruvate MRI may help in understanding how the tumor responds
      to the treatments patients may be receiving.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic pancreatic ductal adenocarcinoma, with at least one
             target lesion in the abdomen measuring >= 1 cm

          -  The subject is able and willing to comply with study procedures and provide signed and
             dated informed consent

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Patients who because of age, general medical or psychiatric condition, or physiologic
             status cannot give valid informed consent

          -  Patients unwilling or unable to undergo magnetic resonance (MR) imaging, including
             patients with contraindications to MRI, such as cardiac pacemakers or non-compatible
             intracranial vascular clips

          -  Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110.
             The addition of anti-hypertensives to control blood pressure is allowed for
             eligibility determination

          -  Congestive heart failure >= class III

          -  Myocardial infarction within the past year

          -  History of QT prolongation on electrocardiogram (EKG), defined as pretreatment QTs >
             440 msec in males or > 460 msec in females

          -  Pregnant and lactating females
Study of SPARC1103 in Subjects With Spasticity
Condition: Spasticity
MeSH terms: Muscle Spasticity
Intervention: SPARC1103 low dose; SPARC1103 high dose; SPARC Placebo
Intervention description: once daily; once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spasticity, Multiple sclerosis

Summary:

      Study of SPARC1103 in subjects with spasticity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women greater than or equal to 18 years of age

          -  Willing to sign the informed consent form

          -  Women of child bearing potential willing to practice an acceptable method of birth
             control

          -  Known history of spasticity due to MS

        Exclusion Criteria:

          -  Administration of an investigational drug or device within 30 days prior to Screening
             Visit 1

          -  Unable to comply with trial procedures in the opinion of the Investigator

          -  Concomitant neurologic conditions causing spasticity

          -  Any medical condition, including psychiatric disease or epilepsy, which would
             interfere with the interpretation of the trial results
Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)
Condition: Choroidal Neovascularization; Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: verteporfin; verteporfin; ranibizumab; dexamethasone
Intervention description: Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds); Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds); 0.5 mg intravitreal injection; 0.5 mg intravitreal injection
Intervention MeSH terms: Dexamethasone; Ranibizumab; Verteporfin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 162.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Macular Degeneration; AMD; CNV; Choroidal neovascularization; Photodynamic therapy; CNV Secondary to Age Related Macular Degeneration

Summary:

      The objective of this study is to determine if combination therapy (reduced-fluence Visudyne
      followed by Lucentis [within 2 hours] or either of two regimens of reduced-fluence Visudyne
      followed by Lucentis-Dexamethasone triple therapy [within 2 hours]) reduces retreatment rates
      compared with Lucentis monotherapy while maintaining similar vision outcomes and an
      acceptable safety profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment naive for choroidal neovascularization (CNV) secondary to age-related
             macular degeneration (AMD) in the study eye except for laser treatment outside the
             subfoveal area

          -  Subfoveal CNV due to AMD

          -  CNV must be = or >50 % of the entire lesion

          -  All lesion composition types with a lesion greatest linear dimension (GLD) < 5400
             microns (approximately = or <9 disc areas [DA])

          -  Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA
             score) of 25 - 73 letters (approximate Snellen equivalent of 20/40 - 20/320),
             inclusive

        Exclusion Criteria:

          -  Subfoveal geographic atrophy or subfoveal fibrosis of the study eye

          -  Intraocular surgery within 3 months of enrollment

          -  Inability to attend the protocol-required visits

          -  Known allergies or hypersensitivity to any of the study treatments.

          -  Other systemic diseases or active uncontrolled infections that would make subject a
             poor medical risk

          -  Uncontrolled glaucoma, defined as (1)subject is on >1 glaucoma medication (includes
             combination treatments) or (2)subject has glaucoma that could lead to progressive
             visual field deterioration

          -  If subject has had a stroke within the last year
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Condition: Reduction in Hypertrophic Skin Scarring
MeSH terms: Cicatrix
Intervention: EXC 001; EXC 001; EXC 001; EXC 001
Intervention description: Single-dose administered by injection four different times; Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1; Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2; Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Skin scarring; cicatrix; breast scar

Summary:

      The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing
      skin scarring in subjects undergoing revision of scars from prior surgery. The study will
      also evaluate the safety and tolerability of EXC 001 and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have previous had breast surgery resulting in unacceptable scars.

          -  Subject has chosen to have breast scars revised.

          -  Subject must not be pregnant or lactating.

        Exclusion Criteria:

          -  Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or
             lactating.

          -  Participation in another clinical trial within 30 days prior to the start of the
             study.

          -  Any other condition or prior therapy, which, in the opinion of the PI, would make the
             subject unsuitable for the study.
Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Condition: Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bendamustine hydrochloride; Bortezomib; Dexamethasone
Intervention description: Given IV; Given SC; Given PO
Intervention MeSH terms: Dexamethasone; Bortezomib; Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib,
      and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used
      in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways
      to stop the growth of cancer cells, either by killing the cells, by stopping them from
      dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells
      by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride
      with bortezomib and dexamethasone may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          1. New diagnosis of multiple myeloma with no prior history of systemic treatment
             (Exceptions include corticosteroids, bisphosphonates, single agent cyclophosphamide,
             <= 21 days of the first cycle of a planned regimen

          2. >= 18 years of age

          3. ECOG <= 3

          4. Signed informed consent

          5. Measurable serum paraprotein on SPEP or serum free light chains and ratio, or
             quantifiable Bence-Jones proteinuria on 24 hour urine specimen. If the monoclonal
             protein has merged with the beta region we will follow the serum immunoglobulin of the
             involved heavy chain and comment on either partial remission (PR, as judged by two
             protocol investigators) or complete remission (CR, as defined by the achievement of PR
             as above and the resolution of the monoclonal protein by immunofixation in the serum
             and urine.)

        Exclusion Criteria:

          1. Failure to sign informed consent

          2. Smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), or
             plasma cell leukemia

          3. History of previously treated smoldering myeloma

          4. Grade 3 or above peripheral neuropathy

          5. Uncontrolled human immunodeficiency virus (HIV)

          6. Active hepatitis A, B or C

          7. Pregnant or lactating females

          8. Total bilirubin >3 times the upper limit of normal

          9. ASLT/ALT > 2.5 times the upper limit of normal
A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers
Condition: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: MM-121; Paclitaxel
Intervention description: MM-121 (SAR256212) (IV); Standard dosing Paclitaxel (IV)
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Platinum-resistant; Platinum-refractory; Fallopian tube cancer; Peritoneal Cancer; Paclitaxel; ErbB3; Phase II; locally advanced/metastatic or recurrent

Summary:

      To determine whether the combination of MM-121 plus paclitaxel is more effective than
      paclitaxel alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube
             cancer or primary peritoneal cancer

          -  Received at least one prior platinum based chemotherapy regimen

          -  Platinum-resistant or refractory

          -  Eligible for weekly paclitaxel

          -  Adequate liver and kidney function

          -  18 years of age or above

        Exclusion Criteria:

          -  Evidence of any other active malignancy

          -  History of severe allergic reactions to paclitaxel or other drugs formulated in
             Cremophor®EL