bioihbjkbjnl/mcl2 huggingface dataset:
CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transportation for T and B Cell Depletion
Condition: Immunodeficiencies
MeSH terms: Immunologic Deficiency Syndromes
Intervention: CliniMACs
Intervention description: T and B Cell depletion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Maximum age: 22 Years
Healthy volunteers: No
Keywords: Blood and Marrow Transplant; T cell Depletion; Unrelated; Related; Donor

Summary:

      This is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (GVHD)
      in patients receiving unrelated or partially matched related donor peripheral stem cells
      using the CliniMACS system to positively deplete T cells to prevent severe GVHD. Feasibility
      will be tested, focusing on engraftment, treatment-related mortality (with a specific focus
      on interstitial pneumonitis) and severe GVHD.
    

Eligibility criteria:

        Inclusion Criteria:

        As of October 2014 this study closed enrollment to malignant diseases. This study remains
        open to:

        Non-malignant diseases:

          1. Bone marrow failure, including severe aplastic anemia

          2. Immunodeficiencies

        Exclusion Criteria:

        1. Patients who have had prior stem cell transplant (SCT) and bone marrow transplant (BMT)
        are excluded for study enrollment.
Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Intervention: Ruxolitinib
Intervention description: Ruxolitinib was supplied as SR and IR formulated tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: myelofibrosis; myeloproliferative neoplasms; PMF; PET-MF; PPV-MF

Summary:

      The purpose of this study is to determine the safety and tolerability of ruxolitinib
      (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis
      (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants 18 years of age or older.

          -  Participants must be diagnosed with primary myelofibrosis (PMF), post-essential
             thrombocythemia myelofibrosis (PPV-MF), or post-polycythemia vera myelofibrosis
             (PET-MF).

          -  Participants with myelofibrosis requiring therapy must be classified as high risk (3
             or more prognostic factors), intermediate risk level 2 (2 prognostic factors), or
             intermediate risk level 1 (1 prognostic factor)defined by International Working Group
             for Myelofibrosis Research and Treatment (IWG-MRT).

          -  Participants must have a palpable spleen measuring 5 cm or greater below the costal
             margin.

        Exclusion Criteria:

          -  Participants with a life expectancy of less than 6 months.

          -  Participants of childbearing potential who are unwilling to take appropriate
             precautions to avoid pregnancy or fathering a child.

          -  Participants with inadequate bone marrow reserve.

          -  Participants with history of platelet counts < 50,000/μL, platelet transfusion(s), or
             an absolute neutrophil count < 500/μL in the month prior to Screening.

          -  Participants with inadequate liver or renal function at Screening and Baseline visits.
Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial
Condition: Primary Systemic Amyloidosis
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Intervention: Doxycycline
Intervention description: Doxycycline will be continued until one of the following criteria is met:
Patient has completed 1 year of doxycycline therapy
Patient develops any grade 3-4 toxicity related to doxycycline use.
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AL amyloidosis; amyloidosis; light chain amyloidosis

Summary:

      In this study the investigators want to find out more about the addition of the antibiotic,
      doxycycline, to standard anti-amyloid therapy in people with amyloidosis. The investigators
      want to find out whether doxycycline improves the response to standard anti-amyloid therapy
      and whether it causes any problems (side effects).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with biopsy proven AL amyloidosis.

          2. Patients ≥ 18 years of age are eligible.

          3. Patient must provide informed consent.

          4. All patients must have measurable amyloid organ involvement of a vital organ (eg.
             heart, liver, kidneys). Localized amyloidosis will also be eligible as long as the
             amyloid involvement is radiologically measurable.

          5. A negative pregnancy test will be required for all women of child bearing potential.
             Breast feeding is not permitted.

          6. Patients who have previously been taking doxycycline will be eligible as long as there
             is no contraindication to stay on doxycycline 100 mg twice daily (BID) for 1 year in
             the opinion of the treating physician.

          7. Creatinine clearance of >25 ml/min.

        Exclusion Criteria:

          1. Patients with severe malabsorption syndrome precluding absorption of oral agents will
             be excluded.

          2. Known intolerance or allergic reactions with doxycycline.

          3. Previous chemotherapy for AL amyloidosis.
Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: AZD1656; Placebo
Intervention description: Subjects will be treated with tolerable dose twice daily for another 24 days.; Subjects will be treated with tolerable dose twice daily for another 24 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 27.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type II Diabetes

Summary:

      The purpose of this study is to assess the 1 month safety and tolerability after multiple
      oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or women of non-childbearing potential (postmenopausal, and/or have undergone
             hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)

          -  Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8
             weeks prior to randomisation

          -  HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and
             Complications Trial [DCCT] standard)

        Exclusion Criteria:

          -  History of ischemic heart disease, symptomatic heart failure, stroke, transitory
             ischemic attack or symptomatic peripheral vascular disease

          -  Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine
             analysis results. Positive test for Hepatitis B surface antigen or antibodies to human
             immunodeficiency virus (HIV) or antibodies to Hepatitis C virus
A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Tralokinumab; Tralokinumab; Placebo
Intervention description: Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.; Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.; Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 409.0
Sex: All
Minimum age: 50 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function
      in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic,
      progressive, irreversible, and usually fatal lung disease of unknown cause.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  1) IPF diagnosis for <= 5 years prior to Visit 1 (screening). Confirmation of
             diagnosis of IPF in accordance is required for subject inclusion 2) Confirmed
             diagnosis of IPF by clinical characteristics, HRCT and surgical lung biopsy (if
             required) 3)Mild to moderate IPF to include all of the following at screening:

               1. FVC >= 50% predicted normal

               2. Partial pressure of oxygen in arterial blood (PaO2) of >= 55 mmHg on room air or
                  50 mmHg at high altitude (> 1500 meters), or oxygen saturation by pulse oximetry
                  (SpO2) of >= 90%on room air at rest

               3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) >= 30%
                  predicted normal 4) Be able to walk >= 100 meters unassisted

        Key Exclusion Criteria:

          1. A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator)

          2. The extent of emphysema on the HRCT is greater than the extent of fibrosis.

          3. Currently listed for lung transplantation

          4. Use of the following medications:

               1. Immunosuppressive medications (eg, methotrexate, cyclosporine, azathioprine,
                  intramuscular long-acting depot corticosteroid) within 3 months prior to Visit 1
                  (screening). Oral prednisone <= 15 mg/day (or equivalent oral corticosteroid) is
                  allowed for chronic use if subject was on a stable dose at least 30 days prior to
                  Visit 1 (screening)

               2. Pirfenidone within 4 weeks prior to Visit 1 (screening)

               3. N-acetylcysteine within 4 weeks prior to Visit 1 (screening)

               4. Live attenuated vaccines within 4 weeks prior to Visit 1 (screening)
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
Condition: Dermatomyositis
MeSH terms: Dermatomyositis
Intervention: JBT-101; Placebo
Intervention description: Part A: 20 mg once daily on Days 1-28, then 20 mg twice daily on Days 29-84.
Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE.; Part A: Once daily on Days 1-28, then twice daily on Days 29-84.
Part B: Placebo twice daily on Days 1 - 365 of the OLE.
Intervention MeSH terms: Lenabasum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: JBT-101, lenabasum, dermatomyositis

Summary:

      The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in
      adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3
      months treatment with hydroxychloroquine.
    

Eligibility criteria:

        Inclusion Criteria (Part A):

          -  CDASI activity score ≥ 14;

          -  No difficulty with lifting or walking, and no more than 1.5 x the upper limit of
             normal of creatine phosphokinase or aldolase;

          -  Failed at least 3 months treatment with hydroxychloroquine;

          -  Stable treatment for dermatomyositis for at least 28 days before Visit 1 (Day 1).

        Inclusion Criteria (Part B):

          -  Completion of dosing in Part A without permanent discontinuation of study product
             because of safety or tolerability reasons

        Exclusion Criteria (Part A and B):

          -  Significant diseases or conditions other than DM that may influence response to the
             study product or safety;

          -  Any one of the following values for laboratory tests at Screening:

               1. A positive pregnancy test (or at Visit 1);

               2. Hemoglobin < 10 g/dL;

               3. Neutrophils < 1.0 x 10^9/L;

               4. Platelets < 75 x 10^9/L;

               5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation;

               6. Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase >
                  2.5 x upper normal limit;

               7. Total bilirubin ≥ 1.5 x upper limit of normal.

          -  Any other condition that, in the opinion of the Principal Investigator, is clinically
             significant and may put the subject at greater safety risk, influence response to
             study product, or interfere with study assessments.
Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: ESL Banana taste; ESL Grape taste; ESL Tutti-Frutti taste
Intervention description: oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.; oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.; oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 5 Years
Maximum age: 8 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the taste preference in children of 3 different
      flavours of the ESL oral suspension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A written informed consent form signed by the subject's parent(s) or guardian(s) and
             an assent form for any 7-year-old subjects signed by subjects.

          -  Male or female, between the age of 5 to <8 years.

          -  Diagnosed with partial-onset epilepsy.

          -  Is considered, in the opinion of the investigator, to be able to make the required
             taste assessment.

        Exclusion Criteria:

          -  Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic,
             haematological, or oncology disorder.

          -  Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants.

          -  Strong congestion, flu, or any other acute illness that could influence the child's
             sense of taste.

          -  A known swallowing or taste perception problem.

          -  Currently or previously treated with ESL.

          -  Concomitant participation in another drug clinical trial.

          -  Any other condition or circumstance that, in the opinion of the investigator, could
             compromise the subject's ability to comply with the study protocol.
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: AZD9668; AZD9668 Placebo equivalent
Intervention description: 60 mg, oral tablet, twice daily for 28 days; Match placebo to 60 mg, oral tablet, twice daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: cystic fibrosis

Summary:

      The purpose of this study is to investigate if treatment with AZD9668 for 28 days is
      effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance
      which does not have any action).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or post-menopausal or surgically sterile female patients

          -  Have a clinical diagnosis of Cystic Fibrosis with lung function tests greater or equal
             to 40% of normal

          -  Have normal renal function

        Exclusion Criteria:

          -  Lung transplant patients

          -  Significant liver disease

          -  Any other non-CF-related lung disease that may interfere with study assessments
A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: TMC435
Intervention description: From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
Intervention MeSH terms: Simeprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C; TMC435

Summary:

      The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of
      TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never
      received treatment for their hepatitis C infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV)
             infection

          -  Participants who have never received treatment for their HCV infection

          -  Participants with either no cirrhosis or up to Child Pugh A liver disease

          -  Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at
             screening

        Exclusion Criteria:

          -  Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease
             defined as prior or current history of ascities, hepatic encephalopathy, esophageal or
             gastric varices

          -  Participants with diagnosed or suspected hepatocellular carcinoma

          -  Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A
             or B virus infection or active tuberculosis at screening

          -  Participants with any active clinically significant disease, or medical history or
             physical examination or electrocardiogram findings during screening
Exploratory Subjective Sleep Study of a Prototype Nasal Dilator
Condition: Sleep Disorders; Congestion, Nasal
MeSH terms: Sleep Wake Disorders
Intervention: Prototype Nasal Dilator; Marketed Nasal Strip; Placebo Nasal Strip
Intervention description: Prototype nasal dilator AB2R11; Breathe Right Nasal Strip- Clear small/medium; Placebo strip
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: trouble with sleep; night time nasal congestion

Summary:

      The purpose of this exploratory study is to evaluate the subjective measures of congestion
      and sleep quality in subjects who suffer from chronic nasal congestion and report trouble
      with their sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with leptorrhine noses

          -  Subjects suffering from chronic nocturnal nasal congestion and report trouble with
             sleep
Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Condition: Choroidal Neovascularization; Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: hI-con1; ranibizumab; Sham injection
Intervention description: Intravitreal injection of hI-con1 0.3 mg; Intravitreal injection of ranibizumab 0.5 mg; No injection is given, a needleless syringe is used to mimic an injection.
Intervention MeSH terms: Ranibizumab; hI-con1; Immunoconjugates
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic
      effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in
      combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating
      patients with choroidal neovascularization (CNV) secondary to age-related macular
      degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females of any race at least 50 years of age

          -  Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular
             Degeneration (AMD) in the study eye

          -  Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to
             20/320) in the study eye

        Exclusion Criteria:

          -  Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in
             the better seeing eye

          -  Any prior treatment of CNV or advanced AMD in the study eye, except for dietary
             supplements or vitamins

          -  Any intraocular or ocular surface surgery (including cataract surgery and laser
             procedures) in the study eye within 3 months

          -  Vitrectomy in the study eye

          -  Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)