bioihbjkbjnl/mcl2 huggingface dataset:
Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects
Condition: Healthy
Intervention: 18F-DTBZ AV-133
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 18F-DTBZ AV-133 imaging

Summary:

      A total 25 healthy subjects will be included in this study. Subjects between 20 and 80 years
      of age may be eligible for this study. Candidates are screened with a medical history and
      physical examination, and blood test.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female age 20 years to 80 years.

          2. Subjects without significant neuropsychiatric disorder after evaluation by
             Neurologist.

          3. Subjects who provide a written informed consent prior to study entry. If the subject
             is incapable of informed consent, the caregiver may consent on behalf of the subject
             (the subject must still confirm assent).

        Exclusion Criteria:

          1. Pregnancy and breast feeding.

          2. Significant recent (within 6 months) history of neurological (including stroke and
             brain trauma) or psychiatric disorder.

          3. Alcohol or substance abuse within last year.

          4. Parkinson's disease or other brain degenerative disease (spinocerebellar ataxia,
             Wilson's disease, hydrocephalus, multiple infarction, history of severe head injury or
             intracranial operation.

          5. Unable to stay still in the MRI or PET scanner for 30 minutes.
BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: dimethyl fumarate
Intervention description: Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: BG00012; MS; RRMS

Summary:

      The primary objective of the study is to evaluate the safety and tolerability of BG00012
      (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer
      acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS)
             according to McDonald criteria #1-4 (Polman et al, 2005 [Appendix I]), and have a
             prior brain magnetic resonance imaging (MRI) demonstrating lesion (s) consistent with
             multiple sclerosis (MS) from any point in time.

          -  Must have an Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive.

          -  Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or
             GA for at least 12 months consecutively at the time of enrollment and remain on this
             treatment for the duration of the study. Participants receiving Rebif must be
             prescribed 44 μg by subcutaneous injection three times per week.

        Key Exclusion Criteria:

          -  Primary progressive, secondary progressive, or progressive relapsing MS (as defined by
             Polman et al. 2005).

          -  Other chronic disease of the immune system, malignancies, acute urologic, or pulmonary
             disease.

          -  Pregnant or nursing women.

          -  Participation within 6 months prior to study enrollment in any other drug, biologic,
             or device study.

        NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
Condition: Relapsing Forms of Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: dimethyl fumarate; tetanus diphtheria toxoids vaccine; 23-valent pneumococcal polysaccharide vaccine; meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent); non-pegylated interferon
Intervention description: Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera.; Administered as described in the treatment arm; Administered as described in the treatment arm; Administered as described in the treatment arm; Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.
Intervention MeSH terms: Interferons; Dimethyl Fumarate; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: vaccine; pneumococcal; meningococcal; tetanus diphtheria; immune response

Summary:

      Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria
      toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have
      been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon
      (IFN).

      Secondary objective is to evaluate the immune response to vaccination with 23-valent
      pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response]
      and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T
      cell-dependent neoantigen response].
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have a confirmed diagnosis of relapsing remitting MS per the 2010 McDonald
             criteria.

          -  Must have a known tetanus immunization history with most recent tetanus vaccination
             given 2 to 15 years prior to Screening and an anti-tetanus serum immunoglobulin titer
             at Screening that is less than or equal to one-half the upper limit of detection for
             the assay.

          -  Must have been on a stable approved dose of Tecfidera (240 mg twice daily [BID])
             [Group 1] for ≥6 months or on a stable approved dose of a non-pegylated IFN (e.g.,
             Avonex, Betaseron, Rebif, Extavia) [Group 2] for ≥3 months prior to Day 1.

        Key Exclusion Criteria:

          -  Clinical relapse requiring treatment within 30 days prior to Day 1.

          -  Pneumococcal vaccination within 5 years prior to Screening.

          -  Previous exposure to meningococcal vaccines.

          -  Known hypersensitivity to Td, PPSV23, or MCV4 or their components.

        NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: Nitric Oxide; Nitrogen
Intervention description: 40 ppm of Nitric Oxide continuously administered for 48 hours; Nitrogen (N2) administered at 40 ppm for 48 hours
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Left Ventricular Assist Device Implantation; Progressive Left Ventricular Failure

Summary:

      The purpose of this study is to assess the utility of nitric oxide for inhalation during left
      ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is
      to be assessed by the number of patients in each treatment group meeting failure criteria
      within 24 hours on study drug, as defined by two or more of the following:

        -  Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2

        -  Administration of ≥ 20 inotropic equivalents (IE)

             -  10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE

             -  0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE

             -  1 µg/kg/min milrinone is equivalent to 15 IE

             -  0.1 U/min vasopressin is equivalent to 10 IE

        -  Mean arterial pressure (MAP) ≤ 55 mmHg

        -  Central venous pressure (CVP) ≥ 16 mmHg

        -  Percent mixed venous oxygen saturation (SvO2) ≤ 55%

      Or at least one of the following criteria:

        -  Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure.
           Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues
           will not be considere 'failure to wean'

        -  Death
    

Eligibility criteria:

        Inclusion criteria:

          -  Scheduled to undergo their first LVAD implantation, (or at least 6 months after
             explanation of a previous LVAD).

          -  Has a pulmonary vascular resistance of at least 2.5 Wood units (200 dynes/sec.) in the
             30 days prior to LVAD placement.

          -  Greater than 18 years of age.

          -  Signed IRB approved informed consent.

        Exclusion criteria:

          -  Patients with congestive heart failure due to giant cell myocarditis or restrictive
             cardiomyopathy.

          -  Elective Biventricular Assist Device (BiVAD) surgery, or current support with a
             temporary BiVad.

          -  LVAD procedure expected to be done without cardiopulmonary bypass.

          -  Pregnancy (a negative pregnancy test must be documented prior to enrollment).

          -  Received nitric oxide by inhalation therapy within the past 24 hours.

          -  Investigational drugs that are expected to change systemic or pulmonary vascular
             resistance are not allowed.
A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Condition: Mantle Cell Lymphoma; Lymphoma, Mantle-Cell
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Lenalidomide; Investigators choice single agent
Intervention description: For patients with a creatinine clearance of ≥ 60 mL/min: 25 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.
For patients who have a moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but < 60mL/min: 10 mg daily x 21 days of a 28 day cycle (Cycles 1 and 2). After Cycle 2, if the patient remains free of Grade 3 or Grade 4 toxicity, the dose will be increased to 15 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.; Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mantle Cell Lymphoma; Relapsed Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma; Lymphoma; MCL

Summary:

      To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients
      with relapsed or refractory mantle cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven mantle cell lymphoma

          -  Patients who are refractory to their regimen or have relapsed once, twice or up to
             three times and who have documented progressive disease

          -  Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2

          -  Willing to follow pregnancy precaution

        Exclusion Criteria:

          -  Any of the following laboratory abnormalities

          -  Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5 x 10^9/L)

          -  Platelet count < 60,000/mm^3 (60 x 10^9/L)

          -  Serum aspartate transaminase/serum glutamic oxaloacetic transaminase(AST/SGOT) or
             alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >3.0 x upper limit
             or normal (ULN), except patients with documented liver involvement by lymphoma

          -  Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented
             liver involvement by lymphoma.

          -  Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min

          -  History of active central nervous system (CNS) lymphoma within the previous 3 months

          -  Subjects not willing to take deep venous thrombosis (DVT) prophylaxis

          -  Known seropositive for or active viral infection with human immunodeficiency virus
             (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
             sero-positive because of hepatitis B virus vaccine are eligible
Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab; Vemurafenib
Intervention MeSH terms: Ipilimumab; Vemurafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety profile of vemurafenib, 960 mg,
      administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600
      mutated advanced/metastatic melanoma.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Key Inclusion Criteria:

          -  Men and women 18 years of age and older

          -  Histologic diagnosis of malignant melanoma tested positive for the BRAF V600 mutation

          -  Previously untreated unresectable Stage III or Stage IV melanoma

          -  Complete set of brain/neck, chest, abdomen/pelvis axial radiographs taken within 28
             days of first dose of study drug

          -  Measurable melanoma by physical or radiographic examination

          -  Brain metastases stable after radiation for at least 1 month and off corticosteroid
             therapy for ≥30 days prior to enrollment

          -  Eastern Cooperative Oncology Group performance status of 0 or 1

          -  Adequate hematologic parameters and renal and hepatic function

        Key Exclusion Criteria:

          -  Primary ocular melanoma

          -  Active brain metastases with symptoms or requiring corticosteroid treatment

          -  Any other malignancy from which the patient has been disease-free for less than 2
             years, with the exception of adequately treated and cured basal or squamous cell skin
             cancer, superficial bladder cancer, or carcinoma in situ of the cervix

          -  History of or current active autoimmune diseases, including but not limited to
             inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune
             hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis,
             autoimmune neuropathies

          -  History of or current immunodeficiency disease, splenectomy, or splenic irradiation

          -  Prior anticancer therapy or investigational products <4 weeks prior to enrollment

          -  Prior therapy with a BRAF or MEK inhibitor and prior investigational anticancer
             immunotherapies;

          -  Prior therapies with immunosuppressive agents within the past 2 years

          -  Concomitant therapy with any anticancer or potent immunosuppressive agent, surgery,
             radiotherapy, other investigational anticancer therapies, or chronic use of systemic
             corticosteroids
Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: dexamethasone Intravitreal Implant; ranibizumab
Intervention description: Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.; Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
Intervention MeSH terms: Dexamethasone; Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal
      implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular
      edema (DME).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 1 or 2 diabetes mellitus

          -  Diagnosis of macular edema

          -  Visual acuity between 20/200 to 20/40

        Exclusion Criteria:

          -  Eye surgery to the study eye within 3 months

          -  Use of Ozurdex® within 9 months

          -  Any active ocular inflammation and infection

          -  Diagnosis of glaucoma

          -  Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic
             use (e.g., Avastin®) within 6 months
The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)
Condition: Essential Thrombocythaemia
MeSH terms: Thrombocytosis; Thrombocythemia, Essential
Intervention: anagrelide hydrochloride; anagrelide hydrochloride
Intervention description: Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.; Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.
Intervention MeSH terms: Anagrelide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Age related differences in response to a drug could arise from variation in pharmacokinetic
      (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety
      profile of anagrelide is well established through a well-documented clinical trial programme
      in patients of all ages, no formal studies have been carried out to investigate whether the
      PK profile of anagrelide and its metabolites is altered with age.

      This study is designed to allow comparisons to be made in terms of pharmacokinetics of
      anagrelide and its metabolites between elderly (≥ 65 years) and young (18-50 years) ET
      patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Young patients aged 18-50 years inclusive or Elderly patients aged 65 years and over

          -  Patients must have a confirmed diagnosis of ET.

          -  Currently receiving anagrelide hydrochloride at a stable maintenance dose < 5 mg/day
             for at least 4 weeks.

        Exclusion Criteria:

          -  Diagnosis of any other myeloproliferative disorder.

          -  Current use of tobacco in any form (e.g. smoking or chewing)

          -  Treatment with any known enzyme altering agents (barbiturates, phenothiazines,
             cimetidine etc.) within 30 days prior to or during the study.

          -  Patients for whom use of another cytoreductive agent in addition to anagrelide is
             considered necessary for control of platelet count.
A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Dabigatran etexilate; Dabigatran etexilate; Warfarin
Intervention description: Dabigatran etexilate 110 mg capsule, twice a day, oral administration; Dabigatran etexilate 150 mg capsule, twice a day, oral administration; Dose-adjusted warfarin based on target INR values
Intervention MeSH terms: Warfarin; Dabigatran
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 174.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048)
      administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with
      non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with
      warfarin.
    

Eligibility criteria:

        Inclusion criteria Inclusion criteria

          1. Patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent)

          2. Patients who had additional risk factor for thromboembolism; one or more of the
             following conditions/events:

               -  Hypertension

               -  Diabetes mellitus

               -  Left-side heart failure

               -  A previous ischemic stroke or transient ischemic attack

               -  Age 75 years or older

               -  A history of coronary artery diseases

        Exclusion criteria Exclusion criteria

          1. Patients diagnosed as having a valvular heart disease by echocardiography, or patients
             who had a history of prosthetic valve replacement or valve surgery

          2. Patients who were to receive electric defibrillation or pharmacological defibrillation
             during the study period

          3. Patients who developed stroke or transient ischemic attack within 30 days before the
             date of informed consent

          4. Patients who developed myocardial infarction or were admitted to hospital due to acute
             coronary syndrome or for percutaneous transluminal coronary angioplasty within 3
             months before the date of informed consent or patients underwent coronary stenting
             within 6 months before the date of informed consent

          5. Patients with atrial myxoma or left ventricular thrombosis

          6. Patients with contraindication to anticoagulant therapies

          7. Patients scheduled for major surgery or invasive procedure

          8. Patients having major bleeding from non-gastrointestinal organs within 6 months before
             the date of informed consent

          9. Patients with uncontrolled hypertension