0 Beoordelingen
ID

16828

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00060840

Trefwoorden

Versies (1)
  1. 09-08-16 09-08-16 -
Geüploaded op

9 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Congestive Heart Failure NCT00060840

    Engels

    Eligibility Congestive Heart Failure NCT00060840

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

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

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0397130 (Implantation of left ventricular assist device)
    SNOMED
    232967006
    UMLS CUI [1,2]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [1,3]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    UMLS CUI [2,1]
    C0561946 (Removal of implant (procedure))
    SNOMED
    284101009
    UMLS CUI [2,2]
    C0181598 (Left ventricular assist device)
    SNOMED
    360066001
    has a pulmonary vascular resistance of at least 2.5 wood units (200 dynes/sec.) in the 30 days prior to lvad placement.
    Beschrijving

    Pulmonary Vascular Resistance Before Implantation of left ventricular assist device

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0456261 (Pulmonary Vascular Resistance)
    SNOMED
    276901002
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [1,3]
    C0397130 (Implantation of left ventricular assist device)
    SNOMED
    232967006
    greater than 18 years of age.
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    signed irb approved informed consent.
    Beschrijving

    Informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients with congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy.
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    UMLS CUI [1,2]
    C0678226 (Due to)
    SNOMED
    42752001
    UMLS CUI [1,3]
    C0264856 (Giant cell myocarditis)
    SNOMED
    60812006
    UMLS CUI [2,1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    UMLS CUI [2,2]
    C0678226 (Due to)
    SNOMED
    42752001
    UMLS CUI [2,3]
    C0007196 (Restrictive cardiomyopathy)
    SNOMED
    90828009
    elective biventricular assist device (bivad) surgery, or current support with a temporary bivad.
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0206058 (Elective Surgical Procedures)
    SNOMED
    274075007
    UMLS CUI [1,2]
    C0179322 (Biventricular assist device)
    SNOMED
    360057000
    UMLS CUI [2,1]
    C1521721 (Supportive assistance)
    UMLS CUI [2,2]
    C0179322 (Biventricular assist device)
    SNOMED
    360057000
    UMLS CUI [2,3]
    C0205374 (Transitory)
    SNOMED
    14803004
    lvad procedure expected to be done without cardiopulmonary bypass.
    Beschrijving

    Left ventricular assist device procedure | Cardiopulmonary Bypass

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0181598 (Left ventricular assist device)
    SNOMED
    360066001
    UMLS CUI [1,2]
    C0184661 (Interventional procedure)
    SNOMED
    71388002
    UMLS CUI [2]
    C0007202 (Cardiopulmonary Bypass)
    SNOMED
    63697000
    pregnancy (a negative pregnancy test must be documented prior to enrollment).
    Beschrijving

    Pregnancy Negative pregnancy test

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,2]
    C0427780 (Pregnancy test negative)
    SNOMED
    250425007
    received nitric oxide by inhalation therapy within the past 24 hours.
    Beschrijving

    administration of inhaled nitric oxide

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1135443 (administration of inhaled nitric oxide)
    investigational drugs that are expected to change systemic or pulmonary vascular resistance are not allowed.
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230 (Investigational New Drugs)
    UMLS CUI [1,2]
    C0392747 (Changing)
    SNOMED
    18307000
    UMLS CUI [1,3]
    C0456261 (Pulmonary Vascular Resistance)
    SNOMED
    276901002
    UMLS CUI [2,1]
    C0013230 (Investigational New Drugs)
    UMLS CUI [2,2]
    C0392747 (Changing)
    SNOMED
    18307000
    UMLS CUI [2,3]
    C1258192 (Total Peripheral Resistance)
    SNOMED
    386530009
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    Similar models

    Eligibility Congestive Heart Failure NCT00060840

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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