bioihbjkbjnl/mcl2 huggingface dataset:
A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: BMS-919373; Placebo (Matching with BMS-919373)
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF)
      through its effect on AF burden (AFB), or the percent of time in AF, in subjects with
      paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg
      QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD,
      respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will
      reduce AF burden as compared to baseline relative to placebo.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Signed informed consent

          -  Paroxysmal Atrial Fibrillation (pAF) with available documentation of AF and reporting
             symptoms within 6 months prior to screening

          -  Able to tolerate withdrawal of antiarrhythmic therapy (rhythm control)

          -  Echocardiographically measured left ventricular ejection fraction (LVEF) ≥40%,measured
             within 12 months of enrollment

          -  Echocardiographically measured left atrial (LA) diameter ≤ 5.0 cm, measured within 12
             months of enrollment

        Exclusion Criteria:

          -  Women of childbearing potential

          -  AFB < 3% or > 70%, during both screening periods independently

          -  Permanent or persistent Atrial Fibrillation

          -  Cardioversion within 3 months of study drug administration

          -  Stroke within 12 months of study drug administration

          -  TIA within 12 months of study drug administration

          -  Heart failure of NYHA class III or greater (symptoms of heart failure at rest or with
             minimal exertion)

          -  Heart failure of NYHA class II (symptoms of heart failure with routine levels of
             exertion)with ejection fraction <40% as measured by echocardiography at any time
             within 12 months of study enrollment (i.e. additional ejection fraction measurements ≥
             40% over this period will not counter this exclusion)

          -  Valvular heart disease (including any valvular insufficiency or stenosis greater
             than"mild")

          -  Ablation within 3 months of study enrollment
Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: G-CSF; Placebo
Intervention description: G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously; Sodium Chloride (NaCl) 0.9 %
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of neuroprotection from
      granulocyte colony-stimulating factor on Parkinson disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hoehn & Yahr stage I~III

          -  Patients with idiopathic Parkinson's disease(PD), who meet the United Kingdom
             Parkinson's Disease Society Brain Bank diagnostic criteria, with a good response to
             levodopa

          -  The onset of PD symptoms must be occurred > = 40 years of age (to exclude YOPD), and
             the patient must have been diagnosed with idiopathic PD > =40 years of age

          -  Patients may have symptoms of wearing OFF and/or levodopa induced dyskinesia

          -  Patients must rate between Hoehn & Yahr stage I to III, when in an OFF medication
             state

          -  Patients must in their optimal medication treatment state, and will not changing their
             medications within 3 months before and after enrollment

        Exclusion Criteria:

          -  Patients who are proved to be Young Onset Parkinson's Disease (YOPD) and/or
             genetically related (e.g. Parkin).

          -  Women of child-bearing potential, pregnant or lactating.

          -  Patients who are proved to have tumor growth and/or malignancy.

          -  Patients with a past (within one year) or present history of psychotic symptoms
             requiring anti- psychotic treatment.

          -  Patients with active symptoms of major depression with suicidal ideation or suicide
             attempt.

          -  Patients with previous brain surgery (including pallidotomy and deep brain
             stimulation).

          -  Patients with significant cognitive impairment ( Mini-Mental State Examination, MMSE <
             24).

          -  Patients who do not sign the inform consent,
Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: somatostatin
Intervention description: Somatostatin may be used to suppress endogenous insulin secretion
Intervention MeSH terms: Somatostatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 1 diabetes; Hypoglycemia unawareness

Summary:

      The long-range goal of this project is to determine the effects of diabetes and the
      hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans.
      We will measure brain glycogen turnover and content in normal controls and subjects with
      diabetes under conditions of modest hyper-and hypoglycemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65

          -  Healthy control

          -  Must be able to provide informed consent

          -  Type 1 diabetes with hypoglycemia unawareness with hemoglobin A1c < 7.5%

          -  Poorly controlled diabetics with hemoglobin A1c > 7.5%

          -  Subjects with hypoglycemia unawareness must report an inability to recognize at least
             some blood glucose values <58 mg/dL during the 3 months prior to the study.

        Exclusion Criteria:

          -  Over 300 pounds

          -  Claustrophobic

          -  History of ischemic heart disease, arrhythmia, of seizure disorder

          -  Pregnant

          -  On medications known to alter blood flow or carbohydrate metabolism

          -  Have internally located pieces of metal
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Condition: Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis
Intervention: CC-90001; Placebo
Intervention description: oral; oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Alcoholic Steatohepatitis; NASH; Non-Alcoholic Fatty Liver; Liver Fibrosis; CC-90001

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational,
      dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with
      placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver
      fibrosis.

      This study is designed to assess response to treatment on measures of fibrosis and other
      efficacy parameters. It will also assess dose response and overall safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence
             of Stage 2, Stage 3 fibrosis based of the non-alcoholic steatohepatitis (NASH)
             Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty
             liver disease (NAFLD) Activity Score (NAS) of 4 or higher

        Exclusion Criteria:

        - Key Exclusion Criteria

          1. History or evidence of decompensated liver disease,

          2. Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic
             steatohepatitis (NASH).

          3. Participant has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening.

          4. History or positive screen for human immunodeficiency virus (HIV) infection or
             congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies
             (eg, common variable immunodeficiency [CVID]).

          5. History of hepatitis B and/or hepatitis C.

          6. History of malignancy within the last 5 years (exceptions: excised and cured
             basal/squamous cell skin carcinomas and cervical carcinoma in situ).

          7. Pregnancy or lactation.
Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa
Condition: Anorexia Nervosa; Osteopenia; Osteoporosis; Eating Disorders
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Intervention: Recombinant Human Growth Hormone; Placebo for Recombinant Human Growth Hormone
Intervention description: Dosage increased in steps for first four weeks. Self injection qd x 12 weeks; Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks
Intervention MeSH terms: Hormones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 21.0
Sex: Female
Minimum age: 14 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Anorexia Nervosa; Eating disorder; Bone; Growth hormone; Osteopenia; Osteoporosis

Summary:

      Decreased bone strength is a serious medical problem present in many women with Anorexia
      Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones
      than women with normal bone strength.

      We are investigating whether a hormone that is naturally produced by the human body, called
      growth hormone, can help strengthen the bones of women with this type of disordered eating.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women between 14 to 45 years with anorexia nervosa

        Exclusion Criteria:

          -  pregnancy

          -  previous history of malignancy.

          -  oral contraceptive pills or other hormones within last 8 - 12 weeks

          -  medications known to affect bone within last 12 weeks

          -  fracture within last 6 months
Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Mesalamine; Placebo
Intervention description: Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm.; 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.
Intervention MeSH terms: Mesalamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome; Irritable Bowel Syndrome Treatment; Mesalamine; Anti-inflammatory drugs; 5-ASA drugs; Apriso ™

Summary:

      The purpose of this study is to find whether treating patients with diarrhea predominant
      Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help
      improve their symptoms of diarrhea, bloating and abdominal pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female aged 18-65 years old

          -  Functional Bowel Disorder Severity Index Score above 37

          -  Normal complete blood count, liver function studies and renal function studies

          -  Serologies done to rule out Celiac Spure or patient has prior negative EGD with small
             bowel biopsies which have been negative

          -  Infectious diarrhea ruled out by stool studies

          -  Negative colonoscopy

        Exclusion Criteria:

          -  Any history of chronic liver disease, heart disease, pulmonary or renal disease

          -  Abnormal EKG

          -  Women with positive pregnancy tests

          -  Patient on steroids, antacids, or warfarin or chronic pain conditions other than
             fibromyalgia

          -  Patients who drink over 2oz alcohol/day on a regular basis Any other causes for
             diarrhea such as IBD, microscopic colitis, celiac disease, history of abdominal
             obstruction, pancreatitis, ileus, or any gastrointestinal bleeding.

          -  Patients with active malignancy in the past five years

          -  Patient with any history of hypersensitivity reactions to salicylate containing
             medications due to cross-sensitivity with mesalamine or allergy to mesalamine
             medications in the past

          -  Any subjects with fibromyalgia will be excluded from the pain testing portion only

          -  History of Phenylketonuria due to the aspartame contained in Apriso
CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma
Condition: T-cell Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: Cyclophosphamide; Doxorubicin; Vincristine; Etoposide; Prednisone; Filgrastim; Plerixafor; Stem Cell Collection; Palifermin; Gemcitabine; Busulfan; Melphalan; Stem Cell Transplant
Intervention MeSH terms: Plerixafor; Prednisone; Cyclophosphamide; Melphalan; Busulfan; Gemcitabine; Doxorubicin; Etoposide; Etoposide phosphate; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: T Cell lymphoma

Summary:

      The current standard of care for the frontline treatment of peripheral T-cell lymphomas
      (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT).
      However, many patients are unable to get to ASCT or relapse after ASCT, with a poor
      prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan
      (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore
      designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the
      results of a phase 2 study of this regimen in patients with PTCL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of T-Cell lymphoma with mandatory pathologic review at Brigham and Women's
             Hospital or Massachusetts General Hospital

          -  Measurable disease

          -  Candidate for Autologous Stem Cell Transplant

        Exclusion Criteria:

          -  Prior anti-lymphoma chemotherapy (except steroids/radiotherapy for urgent palliation,
             one prior cycle of CHOP or up to 2 prior cycles of CHOEP)

          -  Pregnant or breastfeeding

          -  Alk-positive ACL

          -  Significant neuropathy precluding vincristine administration

          -  Known hypersensitivity to any of the agents used in the treatment

          -  Uncontrolled intercurrent illness

          -  Receiving other investigational agents

          -  History of a different malignancy except if disease free for at least 5 years or have
             cervical cancer in situ or basal cell/squamous cell carcinoma of the skin

          -  HIV positive on anti-retroviral therapy
Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: VI-0521; Placebo
Intervention description: phentermine 15mg/topiramate 100mg; matched placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Diabetes, Obese diabetics

Summary:

      The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to
      placebo in the glycemic management of obese diabetic adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent

          -  Type 2 Diabetes

          -  BMI 27-42

          -  Specified diet/exercise and/or diabetes medications

        Exclusion Criteria:

          -  BP > 150/95

          -  Stroke/MI/unstable cardiovascular disease within 6 months

          -  Clinically significant renal, hepatic, or psychiatric disease

          -  Unstable thyroid disease or replacement therapy

          -  Nephrolithiasis

          -  Obesity of known genetic or endocrine origin

          -  Participation in a formal weight loss program or lifestyle intervention

          -  History of glaucoma

          -  Pregnancy or breastfeeding

          -  Alcohol abuse

          -  Eating disorder

          -  Excluded medications
Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)
Condition: Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency; Pulmonary Emphysema; Emphysema
Intervention: Alpha1-Proteinase Inhibitor (Human); Albumin (Human) 20%, United States Pharmacopeia (USP)
Intervention description: Weekly infusion of 60 mg/kg body weight for 2 years; Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%.
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: alpha 1 proteinase inhibitor; alpha1 proteinase inhibitor; congenital emphysema; replacement therapy

Summary:

      The goal of this trial was to explore the utility of evaluating emphysema progression through
      CT scans measuring lung density during a 2 year period of weekly infusions of either placebo
      or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries
      were also collected. All efficacy data were analyzed for potential use in evaluating
      Prolastin efficacy in this and other clinical trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with pulmonary emphysema due to severe congenital AAT deficiency of phenotype
             protease inhibitor Z (PiZ) or other rare genotypes (not MS, MZ or SZ) and AAT serum
             level < 11 microns (µM) or < 80 mg/dL (status to be confirmed by phenotyping and
             genotyping)

          -  Inspiratory capacity (VC - ERV) > 1.2 L and forced expiratory volume at one second
             (FEV1) < 80% of predicted value post bronchodilator

          -  FEV1/VC < 70% of predicted value post-bronchodilator or transfer factor of carbon
             monoxide (KCO) < 80% of predicted value post-bronchodilator

          -  History of at least one exacerbation in the past 2 years

          -  Written informed consent

        Exclusion Criteria:

          -  FEV1 < 25% of predicted value post-bronchodilator

          -  Augmentation therapy for more than one month with plasma-derived human alpha
             1-antitrypsin (AAT) within the last 2 years

          -  History of lung transplant

          -  Any lung surgery within the past 2 years

          -  On any thoracic surgery waiting list

          -  Diagnosis of liver cirrhosis

          -  Severe concomitant disease

          -  Active pulmonary infection/exacerbations within the last month

          -  Active smoking during the last 6 months or plasma positive for cotinine

          -  Body weight < 42 kg or > 92 kg

          -  Pregnancy or lactation

          -  Women of child-bearing potential without adequate contraception