bioihbjkbjnl/mcl2 huggingface dataset:
Dose Finding Study of HP802-247 in Venous Leg Ulcers
Condition: Venous Leg Ulcer; Venous Stasis Ulcers
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: HP802-247; Placebo (Vehicle)
Intervention description: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.; Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Venous Leg Ulcer (VLU); Venous Stasis Ulcer (VSU); VLU; VSU; Leg Ulcer; Leg Wound

Summary:

      This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This
      research is being done to determine the effectiveness of two dosing frequencies and two
      different concentrations of HP802-247, together with standard care, compared to placebo, plus
      standard care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide informed consent.

          -  Willing to comply with protocol instructions, including allowing all study
             assessments.

          -  Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the
             malleolus.

          -  Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular
             or venous incompetence.

          -  Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24
             months.

        Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Therapy with another investigational agent within thirty (30) days of Screening, or
             during the study.

          -  A target ulcer of non-venous etiologies.

          -  Refusal of or inability to tolerate compression therapy.

          -  Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within
             30 days preceding the Screening Visit.

          -  Therapy of the target ulcer with topical growth factors within 1 week preceding the
             Screening Visit.
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: BIIB033; Placebo; Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 419.0
Sex: All
Minimum age: 18 Years
Maximum age: 58 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the efficacy of BIIB033 in participants
      with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.

      Secondary objectives of this study in this study population are to assess the safety,
      tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)

          -  RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months
             of enrollment.

          -  All male and female subjects of childbearing potential must practice effective
             contraception during the study and be willing and able to continue contraception for
             at least 6 months after their last dose of study treatment

        Key Exclusion Criteria:

          -  A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the
             subject has not stabilized from a previous relapse prior to Screening

          -  Previous history of clinically significant disease.

          -  Plans to undergo elective major procedures/surgeries at any time during the study.

          -  Treatment with any investigational MS drugs within 3 weeks or 5 times the half life
             (whichever is longer) prior to Day 1/Baseline

          -  RRMS subjects with any history of inadequate response to any approved interferon β
             preparation

          -  History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or
             hepatitis B virus

          -  History or evidence of drug or alcohol abuse within 2 years prior to randomization

        Note: Other protocol defined inclusion/exclusion criteria may apply.
A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Cyclophosphamide; Fludarabine; Rituximab
Intervention description: Cyclophosphamide 250 mg/m^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.; Fludarabine 25 mg/m^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.; Rituximab 375 mg/m^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 375 mg/m^2 as IV infusion every 2 months from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of rituximab in combination with
      fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line
      treatment of participants with CLL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CLL according to World Health Organization diagnostic criteria

          -  Active disease

          -  No previous treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

        Exclusion Criteria:

          -  Transformation to aggressive B-cell malignancy (prolymphocytic leukemia, large-cell
             lymphoma, Hodgkin's lymphoma)

          -  Other malignancies except for localized skin cancer

          -  Continuous systemic corticosteroid treatment

          -  Known infection with hepatitis B or C
Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Alemtuzumab plus Fludarabine
Intervention description: Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
Intervention MeSH terms: Fludarabine; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of
      alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL)
      patients who have received at least one prior therapy.

      Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during
      Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of
      each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and
      at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission
      (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients
      demonstrating presumptive signs of a Complete Remission (CR) will receive no further
      treatment but will be followed for response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have confirmed B-CLL.

          -  Patients must have received at least one prior therapy and must require treatment for
             active disease

        Exclusion Criteria:

          -  Treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc)
             within 4 weeks of start of study.

          -  History of significant allergic reaction to antibody therapies that required
             discontinuation of antibody therapy

          -  History of human immunodeficiency virus (HIV) positivity.

          -  Active infection requiring treatment

          -  Pregnancy or lactation

          -  Other severe, concurrent diseases or mental disorders

          -  Central nervous system involvement of chronic lymphocytic leukemia (CLL)
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
Condition: IGA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Intervention: Fostamatinib 150 mg; Fostamatinib 100 mg; Placebo
Intervention description: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks; Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks; Placebo tablet twice daily by mouth, over the course of 24 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: IGA Glomerulonephritis; Nephritis, IGA Type

Summary:

      The purpose of this study is to determine whether fostamatinib is safe and effective in the
      treatment of IgA Nephropathy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal biopsy findings consistent with IgA nephropathy

          -  Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin
             II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated)
             dose

          -  Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day
             at the second Screening Visit

          -  Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other
             anti-hypertensive agents

        Exclusion Criteria:

          -  Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.

          -  Use of > 15 mg/day prednisone (or other corticosteroid equivalent).
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Placebo
Intervention description: 5 mg orally once daily for 20 weeks; 10 mg orally once daily for 20 weeks; 20 mg orally once daily for 20 weeks; 30 mg orally once daily for 20 weeks; 40 mg orally once daily for 20 weeks; Orally once daily for 20 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 427.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Heart Failure; Heart Failure with Reduced Ejection Fraction

Summary:

      The objective of the study is to find the optimal dose of once daily oral neladenoson
      bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with
      reduced ejection fraction (HFrEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 18 years and older

          -  Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class
             II-IV, LVEF ≤ 35% and elevated NT-proBNP

        Exclusion Criteria:

          -  Acute de-novo heart failure

          -  Requirement of any intravenous (IV) treatments following 48 hours prior to
             randomization

          -  Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation,
             mechanical ventilation, or any ventricular assist device)

          -  Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic
             dilated cardiomyopathy
Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
Condition: Vitamin d Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: Mongolian milk without vitamin D; Mongolian milk with vitamin D; UHT milk; Milk Substitute; Seasonal D supplement; Daily D supplement
Intervention description: 710ml per day for 49 days; 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.; 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.; 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.; Deliver dosage of 13,700 IU vitamin D over 7 days; Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 597.0
Sex: All
Minimum age: 9 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin d; children; Mongolia

Summary:

      This intervention study will address the impact of vitamin D fortified milk and vitamin D
      supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone,
      academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for
      eczema) of Mongolian children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children in 3rd and 4th grade from selected Mongolian schools.

          -  School selection will consider:

               -  socioeconomic position;

               -  geographic location;

               -  school size;

               -  current lunch or supplementation program; and

               -  the interest and willingness to participate of the school's administration and
                  faculty.

        Exclusion Criteria:

          -  Allergy to milk or wheat products.
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide
Intervention description: Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Intervention MeSH terms: Lacosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 1 Month
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Lacosamide; Vimpat; Children; Epilepsy; Seizures; Anti-epileptic

Summary:

      The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in
      children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to
      3 other antiepileptic drugs (AEDs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female between 1 month and 17 years of age inclusive

          -  Subject's Body Mass Index (BMI) is within the 5th to 95th percentile for his/her age
             group

          -  Subject has a diagnosis of epilepsy with partial-onset seizures

          -  Subject has been observed to have uncontrolled partial-onset seizures after an
             adequate course of treatment with at least 2 anti-epileptic drugs (AEDs) (concurrently
             or sequentially)

          -  Subject has been observed to have at least 2 countable seizures in the 4-week period
             prior to Screening

          -  Subject is on a stable dosage regimen of 1 to 3 AEDs

        Exclusion Criteria:

          -  Subject is currently participating or has participated within the last 2 months in any
             study of an investigational drug or experimental device

          -  Subject with seizures that are uncountable due to clustering during the 8-week period
             prior to study entry

          -  Subject is on a ketogenic or other specialized diet

          -  Subject has a history of primary generalized epilepsy

          -  Subject has a history of status epilepticus within the 6-month period prior to
             Screening

          -  Subject is receiving concomitant treatment with felbamate or has received previous
             felbamate therapy within the last 6 months prior to Screening

          -  Subject has taken or is currently taking vigabatrin

          -  Subject is taking monoamine oxidase (MAO) inhibitors or narcotic analgesics

          -  Subject has a lifetime history of suicide attempt, or has suicidal ideation in the
             past 6 months
ADA Gene Transfer Into Hematopoietic Stem/Progenitor Cells for the Treatment of ADA-SCID
Condition: Immunologic Deficiency Syndromes
MeSH terms: Immunologic Deficiency Syndromes
Intervention: Gene Therapy; Busulfan
Intervention description: Infusion of autologous CD34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan; Busulfan is used for non-myeloablative conditioning
Intervention MeSH terms: Busulfan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: SCID; gene therapy; Adenosine deaminase; retroviral vector

Summary:

      This is a phase I/II protocol to evaluate the safety and efficacy of ADA gene transfer into
      hematopoietic stem/progenitor cells for the treatment of adenosine deaminase
      (ADA)-deficiency. This condition is an autosomal recessive form of Severe Combined
      Immunodeficiency (SCID) characterized by impaired immune responses, recurrent infections,
      failure to thrive and systemic toxicity due to accumulation of purine metabolites.
      Transplants from an human leukocyte-antigen (HLA)-identical sibling donor is the treatment of
      choice, but available for a minority of patients. The use of alternative bone marrow donors
      or enzyme replacement therapy is associated with important drawbacks. The drug product
      studied in this protocol consists of autologous cluster of differentiation (CD)34+
      hematopoietic stem/progenitor cells engineered ex vivo with a retroviral vector encoding the
      therapeutic gene ADA. The engineered CD34+ cells are infused following a nonmyeloablative
      conditioning with busulfan to make space in the bone marrow. The study objectives are: a) to
      evaluate the safety and the clinical efficacy of gene therapy, in the absence of enzyme
      replacement therapy; b) to evaluate the biological activity (engraftment, ADA expression) of
      ADA transduced CD34+ cells and their hematopoietic progeny. c) to evaluate the immunological
      reconstitution and purine metabolism after gene therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ADA-SCID with no HLA-identical sibling donor available

          -  pediatric age and at least one of the following criteria:

          -  inadequate immune response after PEG-ADA for > 6 months

          -  patients who discontinued PEG-ADA due to intolerance, allergy or auto-immunity

          -  patients for whom enzyme replacement therapy is not a life long therapeutic option

        Exclusion Criteria:

          -  HIV infection

          -  history or current malignancy

          -  Patients who received a previous gene therapy treatment in the 12 months prior to
             receiving Strimvelis

          -  any other conditions dangerous for the patients according to the investigator
Intensive Glycemic Control for Congestive Heart Failure Exacerbation
Condition: Congestive Heart Failure; Diabetes Mellitus
MeSH terms: Heart Failure; Diabetes Mellitus
Intervention: Intravenous insulin; Subcutaneous insulin
Intervention description: Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.; Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart failure; Hyperglycemia; Hospital; Diabetes Mellitus

Summary:

      Patients with heart failure often have high blood sugar (glucose).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 and above

          -  Admitted (less than 48 hours) to the OSU Ross Heart Hospital with worsening heart
             failure

          -  Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150
             mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or
             HbA1c >6.5%.

        Exclusion Criteria:

          -  Type 1 diabetes

          -  Receiving comfort care measures only

          -  Hospital stay expected to be less than 2 days

          -  Pregnancy

          -  Prisoners

          -  Participation in the study on prior hospitalizations

          -  Acute myocardial infarction within 3 months

          -  End stage renal or liver disease