bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Decitabine
Intervention description: 20mg/m^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.
Intervention MeSH terms: Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; Decitabine; Dacogen; MGI Pharma

Summary:

      The purpose of this study is to determine the overall response rate in patients with
      myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must sign an Institutional Review Board (IRB) -approved informed consent form.

          2. Must be 18 years of age or older.

          3. Must have a diagnosis for MDS fitting any of the recognized French-American-British
             (FAB) classifications and International Prognostic Scoring System (IPSS) greater than
             or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment,
             and cytogenetics within 28 days of receiving study drug. If FAB classification is
             Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must
             be red cell transfusion dependent, defined as needing red cells more frequently than
             once every 4 weeks.

          4. If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8
             weeks before first dose of study drug.

          5. If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12
             weeks before first dose of study drug.

        Exclusion Criteria:

          1. Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive
             malignant disease.

          2. Must not have received any investigational agent within the 30 days preceding the
             first dose of study drug.

          3. Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.

          4. Must not have an active viral or bacterial infection.
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: tralokinumab; placebo
Intervention description: 2 sc injections of every 2 weeks for 12 weeks.; 2 sc injections of every 2 weeks for 12 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: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: tralokinumab; inflammatory bowel disease; moderate to severe ulcerative colitis

Summary:

      The study is designed to evaluate the clinical efficacy and safety of tralokinumab as
      compared to placebo. Investigational product will be administered as subcutaneous injection.
      All patients will continue background therapy for ulcerative colitis as per local standards
      of care in addition to investigational product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed ulcerative colitis at least 90 days prior randomisation.

          -  Men or women age 18 - 75 years.

          -  Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable
             background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of
             glucocorticosteroids, and/or purine analogue) prior to randomization.

          -  Females of childbearing potential who are sexually active with a nonsterilized male
             partner must use highly effective contraception from Day1.

          -  Nonsterilized males or sterilized males who are ≤1 year post-vasectomy who are
             sexually active with a female partner of childbearing potential must use a highly
             effective method of contraception.

        Exclusion Criteria:

          -  Pregnant or breastfeeding women.

          -  History of colostomy.

          -  Current diagnosis of indeterminate colitis, Crohn's disease, ischemic colitis,
             fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited
             to the rectum (ulcerative proctitis).

          -  Hepatitis B, C or HIV.

          -  History of cancer.
A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
Condition: BRAF or NRAS Mutant Metastatic Melanoma
MeSH terms: Melanoma
Intervention: MEK162
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic melanoma,; BRAF-mutant,; NRAS-mutant

Summary:

      The study will assess the safety and efficacy of single-agent MEK162 in adult patients with
      locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring
      BRAFV600E or NRAS mutations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not
             potentially curable with surgery

          -  BRAF or NRAS mutation in tumor tissue

          -  All patients enrolled should provide sufficient fresh or archival tumor sample at
             baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses
             described in the protocol

          -  Evidence of measurable tumor disease as per RECIST

          -  WHO performance status of 0-2

          -  Adequate organ function and laboratory parameters

        Exclusion Criteria:

          -  History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO)
             or any eye condition that would be considered a risk factor for CSR or RVO

          -  Patients with unstable CNS metastasis

          -  Prior treatment with a MEK- inhibitor

          -  Impaired cardiovascular function

          -  HIV, active Hepatitis B, and/or active Hepatitis C infection

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential UNLESS they comply with protocol contraceptive
             requirements

        Other protocol-defined inclusion/exclusion criteria may apply.
Development of an Ergonomic Wheelchair Pushrim
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Intervention: Natural-Fit; PalmRim; Handrim Control Group
Intervention description: Ergonomic handrim for wheelchairs; Ergonomic handrim for wheelchair; Participants were given a new standard handrim to test. This intervention group is the control group.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Wheelchair; Handrims; Rehabilitation; Upper extremity

Summary:

      The purpose of this study is to test the effectiveness of newly designed ergonomic manual
      wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard
      handrim. It is our hope that the new design of the handrims will help reduce upper extremity
      pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim
      was designed to directly address the shortcomings of standard handrims and to improve the
      standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed
      for individuals who have limited hand function, making it difficult to grasp standard
      handrims.
    

Eligibility criteria:

        Natural-Fit

        Inclusion Criteria:

          -  Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)

          -  Use a standard handrim

          -  Between the ages of 18 and 55

          -  Has normal hand function

        Exclusion Criteria:

          -  Pressure Sores

        PalmRim

        Inclusion Criteria:

          -  Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)

          -  Use a vinyl-coated handrim

          -  Between ages 18 and 55

          -  Has impaired hand function

        Exclusion Criteria:

          -  Pressure sores
Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18; PET Scan
Intervention description: 370 megabecquerel (MBq) IV single-dose; positron emission tomography (PET) scan
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F
      18 uptake over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study

        Exclusion Criteria:

          -  Current clinically significant cardiovascular disease, ECG abnormalities, risk factors
             for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation

          -  Current clinically significant infectious disease, endocrine or metabolic disease,
             pulmonary, renal or hepatic impairment, or cancer

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception

          -  Have had a non-study related radiopharmaceutical imaging or treatment procedure within
             7 days prior to the study imaging session

          -  Have received or participated in a trial with investigational medications in the past
             30 days
Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: modafinil 50mg; Placebo oral capsule
Intervention description: 1 capsule oral daily; 1 capsule oral daily
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled delayed start
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: freezing of gait

Summary:

      Freezing of gait is a late stage complication of Parkinson's disease in which patients note
      that their feet feel stuck or glued to the ground. This can lead to imbalance and falls and
      the secondary complications that can result from falls such as fractures and
      hospitalizations. While levodopa can help freezing of gait in some patients, it does not help
      in all, and the dose needed to treat freezing may be limited by side effects of the
      medications. Currently there are no treatments targeted towards freezing of gait and the goal
      of this research is to see if Modafinil could be one such drug to help freezing of gait in
      Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic PD on UK brain bank criteria.

          -  Presence of FOG based on objective assessment by the movement disorders neurologist.

          -  FOG-Q score > 8.

          -  Stable PD therapy (including medications and stimulation) for a period of 3 months
             prior to trial enrollment.

          -  Age ≥ 50 years.

        Exclusion Criteria:

          -  Patients on antidopaminergic medications for a period of less than 1 year from date of
             enrollment.

          -  Patients who may require adjustment of their PD medications over the 6 month period of
             the trial.

          -  History of allergic reactions to Modafinil or armodafinil.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, mitral valve prolapse, left ventricular hypertrophy, chronic obstructive
             pulmonary disease or psychiatric illness/social situations that would limit compliance
             with study requirements.

          -  Individuals who are pregnant or breastfeeding

          -  Non-english speaking individuals who are unable to complete the questionnaires and
             other assessments in English and/or follow instructions in English.
Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: MEDI2070; placebo
Intervention description: 1 iv infusion on Week 0 and Week 4; 1 iv infusion on Week 0 and Week 4
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MEDI2070; inflammatory bowel disease; moderate to severe Crohn's disease

Summary:

      The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to
      placebo. Investigational product will be administered as intravenous infusion in double-blind
      period, and as a subcutaneous injection in open-label period
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.

          -  Men or women age 18 - 65 years at the time of screening.

          -  Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity
             Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1.

          -  No known history of active tuberculosis (TB).

          -  Received at least one anti-TNFα agent for the treatment of CD and did not initially
             respond.

        Exclusion Criteria:

          -  Pregnant or breastfeeding women.

          -  Presence of ileostomy and/or colostomy.

          -  Short bowel syndrome.

          -  Bowel perforation or obstruction.

          -  History of cancer.
Capnometry-Assisted Breathing Training for COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH); Pulmonary Rehabilitation (PR)
Intervention description: Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.; Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 31.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Capnometry-Assisted Breathing Training for COPD (CATCH) is a behavioral intervention that
      aims to promote optimal, self-regulated, mindful breathing. A portable capnometer is used
      in-session to provide continuous visual feedback of Respiratory Rate (RR), End-Tidal Carbon
      Dioxide Tension (ETCO2), and breathing pattern. The tailored CATCH intervention will
      emphasize a slow, quiet, regular, nasal breathing pattern, as well as pursed lips breathing
      (PLB). CATCH is once weekly for 6 weeks, for a total of 6 sessions; each session is
      approximately 60 minutes long. The principal investigator will implement the CATCH
      intervention. The principal investigator will implement the CATCH intervention. Patients will
      use the Address Stress app on a smart phone or computer tablet as part of their home
      breathing exercises.
    

Eligibility criteria:

        Inclusion Criteria:

          -  over 40 years of age

          -  has COPD documented in their electronic medical record, as defined by FEV1/FVC of <
             0.70 on pulmonary function testing (spirometry), or as shown on a chest CT

          -  Can maintain oxygen saturation (SaO2) ≥ 90% on room air at rest

          -  Is medically cleared to participate in NYULMC's outpatient pulmonary rehabilitation
             program

          -  English speaking. Pregnant patients will not be enrolled in the study

        Exclusion Criteria:

          -  Requires 24-hour supplemental oxygen

          -  Has cognitive impairment as measured by ≤23/30 on the Mini Mental State Examination
             (MMSE)

          -  Is actively being treated for lung cancer (E.g. with chemotherapy or upcoming surgery)

          -  Has morbid obesity (BMI > 40)

          -  Is currently smoking

          -  Has unstable cardiac disease defined by a history of a myocardial infarction in the
             past 3 months
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: interferon alfa-2b; peginterferon alfa-2b; ribavirin, USP; external drug infusion pump
Intervention description: subcutaneous continuous infusion at one of three doses for 48 weeks; 1.5 μg/kg subcutaneous weekly for 48 weeks; All patients will receive oral ribavirin; pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hepatitis C; HCV; genotype; sustained virological response; rapid virological response; interferon

Summary:

      The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon
      alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a
      safe and effective treatment for patients with chronic hepatitis C infection as compared to
      patients who receive standard treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed patient consent form

          -  Genotype 1 chronic HCV with detectable HCV RNA

          -  No previous treatment for HCV infection

          -  Hepatitis B and human immunodeficiency virus negative at screening visit

          -  Able and willing to follow contraception requirements

          -  Screening laboratory values, test, and physical exam within acceptable ranges

          -  Weight between 40 kg and 125 kg

          -  Proficiency in the use of the external pump infusion system

        Exclusion Criteria:

          -  Current or planned enrollment in another investigational device or drug study

          -  Anticipated inability to complete all clinic visits and comply with study procedures

          -  History of, or any current medical condition, which could impact the safety of the
             subject during the study

          -  Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease,
             or other known liver disease other than HCV

          -  Alcoholism or substance abuse with <6 documented months of sobriety

          -  Known allergy or sensitivity to interferons or ribavirin

          -  Any other condition that, in the opinion of the Investigator, would make the subject
             unsuitable for enrollment or could interfere with the subject participating in and
             completing the study
Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone propionate 100mcg; Placebo; Vilanterol
Intervention description: all subjects recieve open-label Flovent twice daily duirng the run in and treatment period; Placebo inhalation powder during treatment period; subjects will recieve 4 weeks via NDPI during treament period
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 463.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group,
      placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma.
      Subjects entering the run-in period will stop their current asthma medication and be given
      open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and
      salbutamol/albuterol as required to use throughout the run-in and double-blind treatment
      period. At Visit 3 subjects meeting the randomization eligibility criteria will receive
      vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI)
      once daily for 4 weeks in addition to open-label fluticasone propionate twice daily
      throughout the treatment period. Primary endpoints consist of change from baseline in clinic
      visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period
      in all subjects. Safety assessments include adverse events, oropharyngeal examinations,
      clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all
      subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at
      specific time intervals relative to the dose of study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent from at least one parent/ legal guardian to take part in the
             study.:

          -  Diagnosis of asthma

          -  pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value

          -  Receiving stable asthma therapy of short acting beta-agonist (SABA) plus ICS (total
             daily dose FP 200mcg or equivalent)

        Exclusion Criteria:

          -  history of life-threatening asthma

          -  history of asthma exacerbation for asthma within 6 months prior to screening.

          -  Culture-documented or suspected bacterial or viral infection

          -  significant abnormality or medical condition

          -  Present use of any tobacco products