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ID

17421

Beschreibung

Novel Treatment for Diastolic Heart Failure in Women; ODM derived from: https://clinicaltrials.gov/show/NCT00206232

Link

https://clinicaltrials.gov/show/NCT00206232

Stichworte

  1. 13.09.16 13.09.16 -
Hochgeladen am

13. September 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Heart Failure NCT00206232

    Eligibility Heart Failure NCT00206232

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    women who are 18 years of age or older.
    Beschreibung

    Gender | Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    women with clinical heart failure for > 2 months.
    Beschreibung

    Gender | Heart failure Clinical

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2,1]
    C0018801
    UMLS CUI [2,2]
    C0205210
    women with left ventricular ejection fraction > 50% within 2 months of screening.
    Beschreibung

    Gender | Left ventricular ejection fraction

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0428772
    women with new york heart association class ii or iii heart failure symptoms.
    Beschreibung

    Gender | Symptoms heart failure | New York Heart Association Classification

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C2735647
    UMLS CUI [3]
    C1275491
    brain natriuretic peptide > 62 pg/ml within 2 months of screening.
    Beschreibung

    Brain natriuretic peptide measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1095989
    patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
    Beschreibung

    Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0003015
    UMLS CUI [2]
    C0521942
    blood pressure no more than 150/95.
    Beschreibung

    Blood Pressure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005823
    patient able to walk more than 50 meters at the time of enrollment.
    Beschreibung

    Able to walk Walking distance

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2712089
    UMLS CUI [1,2]
    C0429886
    signed informed consent.
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    current treatment with spironolactone.
    Beschreibung

    Spironolactone

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0037982
    severe hepatic impairment.
    Beschreibung

    Hepatic impairment Severe

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0948807
    UMLS CUI [1,2]
    C0205082
    creatinine > 2.5 mg/dl
    Beschreibung

    Creatinine measurement, serum

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    potassium > 5.0 meq/l
    Beschreibung

    Potassium measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0202194
    intolerance to spironolactone in the past.
    Beschreibung

    intolerance to Spironolactone

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1744706
    UMLS CUI [1,2]
    C0037982
    significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.
    Beschreibung

    Heart valve disease Significant | Disorder of pericardium | Severe chronic lung disease | Cor pulmonale

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018824
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2]
    C0265122
    UMLS CUI [3]
    C3278799
    UMLS CUI [4]
    C0034072
    unstable angina or myocardial infarction within the past 4 weeks.
    Beschreibung

    Angina, Unstable | Myocardial Infarction

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0002965
    UMLS CUI [2]
    C0027051
    severe peripheral vascular disease or other physical conditions that would limit the walking distance.
    Beschreibung

    Peripheral Vascular Disease Severe Limiting Walking distance | Physical Condition Limiting Walking distance

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0085096
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0439801
    UMLS CUI [1,4]
    C0429886
    UMLS CUI [2,1]
    C3714565
    UMLS CUI [2,2]
    C0439801
    UMLS CUI [2,3]
    C0429886
    pregnant or lactating females.
    Beschreibung

    Pregnancy | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    participation in any other drug trial within 30 days prior to randomization.
    Beschreibung

    Study Subject Participation Status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    inability to provide informed consent.
    Beschreibung

    Informed Consent Unable

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582

    Ähnliche Modelle

    Eligibility Heart Failure NCT00206232

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender | Age
    Item
    women who are 18 years of age or older.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Gender | Heart failure Clinical
    Item
    women with clinical heart failure for > 2 months.
    boolean
    C0079399 (UMLS CUI [1])
    C0018801 (UMLS CUI [2,1])
    C0205210 (UMLS CUI [2,2])
    Gender | Left ventricular ejection fraction
    Item
    women with left ventricular ejection fraction > 50% within 2 months of screening.
    boolean
    C0079399 (UMLS CUI [1])
    C0428772 (UMLS CUI [2])
    Gender | Symptoms heart failure | New York Heart Association Classification
    Item
    women with new york heart association class ii or iii heart failure symptoms.
    boolean
    C0079399 (UMLS CUI [1])
    C2735647 (UMLS CUI [2])
    C1275491 (UMLS CUI [3])
    Brain natriuretic peptide measurement
    Item
    brain natriuretic peptide > 62 pg/ml within 2 months of screening.
    boolean
    C1095989 (UMLS CUI [1])
    Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
    Item
    patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
    boolean
    C0003015 (UMLS CUI [1])
    C0521942 (UMLS CUI [2])
    Blood Pressure
    Item
    blood pressure no more than 150/95.
    boolean
    C0005823 (UMLS CUI [1])
    Able to walk Walking distance
    Item
    patient able to walk more than 50 meters at the time of enrollment.
    boolean
    C2712089 (UMLS CUI [1,1])
    C0429886 (UMLS CUI [1,2])
    Informed Consent
    Item
    signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Spironolactone
    Item
    current treatment with spironolactone.
    boolean
    C0037982 (UMLS CUI [1])
    Hepatic impairment Severe
    Item
    severe hepatic impairment.
    boolean
    C0948807 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Creatinine measurement, serum
    Item
    creatinine > 2.5 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    Potassium measurement
    Item
    potassium > 5.0 meq/l
    boolean
    C0202194 (UMLS CUI [1])
    intolerance to Spironolactone
    Item
    intolerance to spironolactone in the past.
    boolean
    C1744706 (UMLS CUI [1,1])
    C0037982 (UMLS CUI [1,2])
    Heart valve disease Significant | Disorder of pericardium | Severe chronic lung disease | Cor pulmonale
    Item
    significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.
    boolean
    C0018824 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0265122 (UMLS CUI [2])
    C3278799 (UMLS CUI [3])
    C0034072 (UMLS CUI [4])
    Angina, Unstable | Myocardial Infarction
    Item
    unstable angina or myocardial infarction within the past 4 weeks.
    boolean
    C0002965 (UMLS CUI [1])
    C0027051 (UMLS CUI [2])
    Peripheral Vascular Disease Severe Limiting Walking distance | Physical Condition Limiting Walking distance
    Item
    severe peripheral vascular disease or other physical conditions that would limit the walking distance.
    boolean
    C0085096 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    C0429886 (UMLS CUI [1,4])
    C3714565 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    C0429886 (UMLS CUI [2,3])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating females.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    participation in any other drug trial within 30 days prior to randomization.
    boolean
    C2348568 (UMLS CUI [1])
    Informed Consent Unable
    Item
    inability to provide informed consent.
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])

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