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ID

16828

Beskrivning

The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation; ODM derived from: https://clinicaltrials.gov/show/NCT00060840

Länk

https://clinicaltrials.gov/show/NCT00060840

Nyckelord

Versioner (1)
  1. 2016-08-09 2016-08-09 -
Uppladdad den

9 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Congestive Heart Failure NCT00060840

    Engelsk

    Eligibility Congestive Heart Failure NCT00060840

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    scheduled to undergo their first lvad implantation, (or at least 6 months after explanation of a previous lvad).
    Beskrivning

    Implantation of left ventricular assist device First Planned | Explantation Left ventricular assist device

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0397130
    UMLS CUI [1,2]
    C0205435
    UMLS CUI [1,3]
    C1301732
    UMLS CUI [2,1]
    C0561946
    UMLS CUI [2,2]
    C0181598
    has a pulmonary vascular resistance of at least 2.5 wood units (200 dynes/sec.) in the 30 days prior to lvad placement.
    Beskrivning

    Pulmonary Vascular Resistance Before Implantation of left ventricular assist device

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0456261
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0397130
    greater than 18 years of age.
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    signed irb approved informed consent.
    Beskrivning

    Informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy.
    Beskrivning

    Congestive heart failure Due to Giant cell myocarditis | Congestive heart failure Due to Restrictive cardiomyopathy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018802
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C0264856
    UMLS CUI [2,1]
    C0018802
    UMLS CUI [2,2]
    C0678226
    UMLS CUI [2,3]
    C0007196
    elective biventricular assist device (bivad) surgery, or current support with a temporary bivad.
    Beskrivning

    Elective Surgical Procedures Biventricular assist device | Support Biventricular assist device Temporary

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0206058
    UMLS CUI [1,2]
    C0179322
    UMLS CUI [2,1]
    C1521721
    UMLS CUI [2,2]
    C0179322
    UMLS CUI [2,3]
    C0205374
    lvad procedure expected to be done without cardiopulmonary bypass.
    Beskrivning

    Left ventricular assist device procedure | Cardiopulmonary Bypass

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0181598
    UMLS CUI [1,2]
    C0184661
    UMLS CUI [2]
    C0007202
    pregnancy (a negative pregnancy test must be documented prior to enrollment).
    Beskrivning

    Pregnancy Negative pregnancy test

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0427780
    received nitric oxide by inhalation therapy within the past 24 hours.
    Beskrivning

    administration of inhaled nitric oxide

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1135443
    investigational drugs that are expected to change systemic or pulmonary vascular resistance are not allowed.
    Beskrivning

    Investigational New Drugs Changing Pulmonary Vascular Resistance | Investigational New Drugs Changing Systemic Vascular Resistance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [1,3]
    C0456261
    UMLS CUI [2,1]
    C0013230
    UMLS CUI [2,2]
    C0392747
    UMLS CUI [2,3]
    C1258192
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    Similar models

    Eligibility Congestive Heart Failure NCT00060840

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Implantation of left ventricular assist device First Planned | Explantation Left ventricular assist device
    Item
    scheduled to undergo their first lvad implantation, (or at least 6 months after explanation of a previous lvad).
    boolean
    C0397130 (UMLS CUI [1,1])
    C0205435 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    C0561946 (UMLS CUI [2,1])
    C0181598 (UMLS CUI [2,2])
    Pulmonary Vascular Resistance Before Implantation of left ventricular assist device
    Item
    has a pulmonary vascular resistance of at least 2.5 wood units (200 dynes/sec.) in the 30 days prior to lvad placement.
    boolean
    C0456261 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0397130 (UMLS CUI [1,3])
    Age
    Item
    greater than 18 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    Informed consent
    Item
    signed irb approved informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Congestive heart failure Due to Giant cell myocarditis | Congestive heart failure Due to Restrictive cardiomyopathy
    Item
    patients with congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy.
    boolean
    C0018802 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C0264856 (UMLS CUI [1,3])
    C0018802 (UMLS CUI [2,1])
    C0678226 (UMLS CUI [2,2])
    C0007196 (UMLS CUI [2,3])
    Elective Surgical Procedures Biventricular assist device | Support Biventricular assist device Temporary
    Item
    elective biventricular assist device (bivad) surgery, or current support with a temporary bivad.
    boolean
    C0206058 (UMLS CUI [1,1])
    C0179322 (UMLS CUI [1,2])
    C1521721 (UMLS CUI [2,1])
    C0179322 (UMLS CUI [2,2])
    C0205374 (UMLS CUI [2,3])
    Left ventricular assist device procedure | Cardiopulmonary Bypass
    Item
    lvad procedure expected to be done without cardiopulmonary bypass.
    boolean
    C0181598 (UMLS CUI [1,1])
    C0184661 (UMLS CUI [1,2])
    C0007202 (UMLS CUI [2])
    Pregnancy Negative pregnancy test
    Item
    pregnancy (a negative pregnancy test must be documented prior to enrollment).
    boolean
    C0032961 (UMLS CUI [1,1])
    C0427780 (UMLS CUI [1,2])
    administration of inhaled nitric oxide
    Item
    received nitric oxide by inhalation therapy within the past 24 hours.
    boolean
    C1135443 (UMLS CUI [1])
    Investigational New Drugs Changing Pulmonary Vascular Resistance | Investigational New Drugs Changing Systemic Vascular Resistance
    Item
    investigational drugs that are expected to change systemic or pulmonary vascular resistance are not allowed.
    boolean
    C0013230 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    C0456261 (UMLS CUI [1,3])
    C0013230 (UMLS CUI [2,1])
    C0392747 (UMLS CUI [2,2])
    C1258192 (UMLS CUI [2,3])
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