0 Bewertungen

ID

12780

Beschreibung

Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00581607

Link

https://clinicaltrials.gov/show/NCT00581607

Stichworte

  1. 21.12.15 21.12.15 -
Hochgeladen am

21. Dezember 2015

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :


    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Eligibility Sarcoidosis NCT00581607

    Eligibility Sarcoidosis NCT00581607

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with known sarcoidosis 21.
    Beschreibung

    sarcoidosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0036202
    age 18 or greater
    Beschreibung

    age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients with documented pulmonary hypertension with a pa mean > 25 mm hg as measured by cardiac catheterization within six months of entry into the study. pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm hg.
    Beschreibung

    pulmonary hypertension; Cardiac Catheterization

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0020542
    UMLS CUI [2]
    C0018795
    patients with who class ii or iii
    Beschreibung

    who class

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0451584
    six minute walk distance of between 100 to 500 meters
    Beschreibung

    walking

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0080331
    patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
    Beschreibung

    immunotherapy sarcoidosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021083
    UMLS CUI [1,2]
    C0036202
    patients able to provide written consent
    Beschreibung

    informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
    Beschreibung

    Vasodilator Agents; calcium channel blocker

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0042402
    UMLS CUI [2]
    C0006684
    patients with severe airway obstruction as defined by fev1/fvc of less than 35%
    Beschreibung

    Airway Obstruction; fev1

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001883
    UMLS CUI [2]
    C0588029
    patients with world health organization (who) class iv status.
    Beschreibung

    who class

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0451584
    patients who are pregnant or breast feeding
    Beschreibung

    pregnant; lactating

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2828358
    UMLS CUI [1,2]
    C0549206
    patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
    Beschreibung

    left ventricular dysfunction

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0242698
    cardiac index < 2.0 liters and/or right atrial pressure >15 mm hg
    Beschreibung

    cardiac index; right atrial pressure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0428776
    UMLS CUI [2]
    C0456165
    significant liver dysfunction not due to sarcoidosis.
    Beschreibung

    liver dysfunction

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
    Beschreibung

    compliance behavior limited comorbidity

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    patients unable to perform the 6 minute walk study
    Beschreibung

    walking

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0080331

    Ähnliche Modelle

    Eligibility Sarcoidosis NCT00581607

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    sarcoidosis
    Item
    patients with known sarcoidosis 21.
    boolean
    C0036202 (UMLS CUI [1])
    age
    Item
    age 18 or greater
    boolean
    C0001779 (UMLS CUI [1])
    pulmonary hypertension; Cardiac Catheterization
    Item
    patients with documented pulmonary hypertension with a pa mean > 25 mm hg as measured by cardiac catheterization within six months of entry into the study. pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm hg.
    boolean
    C0020542 (UMLS CUI [1])
    C0018795 (UMLS CUI [2])
    who class
    Item
    patients with who class ii or iii
    boolean
    C0451584 (UMLS CUI [1])
    walking
    Item
    six minute walk distance of between 100 to 500 meters
    boolean
    C0080331 (UMLS CUI [1])
    immunotherapy sarcoidosis
    Item
    patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
    boolean
    C0021083 (UMLS CUI [1,1])
    C0036202 (UMLS CUI [1,2])
    informed consent
    Item
    patients able to provide written consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Vasodilator Agents; calcium channel blocker
    Item
    patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
    boolean
    C0042402 (UMLS CUI [1])
    C0006684 (UMLS CUI [2])
    Airway Obstruction; fev1
    Item
    patients with severe airway obstruction as defined by fev1/fvc of less than 35%
    boolean
    C0001883 (UMLS CUI [1])
    C0588029 (UMLS CUI [2])
    who class
    Item
    patients with world health organization (who) class iv status.
    boolean
    C0451584 (UMLS CUI [1])
    pregnant; lactating
    Item
    patients who are pregnant or breast feeding
    boolean
    C2828358 (UMLS CUI [1,1])
    C0549206 (UMLS CUI [1,2])
    left ventricular dysfunction
    Item
    patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
    boolean
    C0242698 (UMLS CUI [1])
    cardiac index; right atrial pressure
    Item
    cardiac index < 2.0 liters and/or right atrial pressure >15 mm hg
    boolean
    C0428776 (UMLS CUI [1])
    C0456165 (UMLS CUI [2])
    liver dysfunction
    Item
    significant liver dysfunction not due to sarcoidosis.
    boolean
    C0086565 (UMLS CUI [1])
    compliance behavior limited comorbidity
    Item
    patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    walking
    Item
    patients unable to perform the 6 minute walk study
    boolean
    C0080331 (UMLS CUI [1])

    Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

    Mit * gekennzeichnete Felder sind notwendig.

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video