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ID

14490

Beschrijving

A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00639691

Link

https://clinicaltrials.gov/show/NCT00639691

Trefwoorden

  1. 18-04-16 18-04-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

18 april 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Eligibility Asthma NCT00639691

    Eligibility Asthma NCT00639691

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00639691
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    male or female, ≥ 6years of age;
    Beschrijving

    age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    who have a diagnosis of allergic asthma ≥ 1 year duration according to american thoracic society (ats) criteria;
    Beschrijving

    allergic asthma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0155877
    UMLS CUI [1,2]
    C0040223
    severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per canadian asthma consensus report (1999));
    Beschrijving

    severe persistent allergic asthma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1960048
    UMLS CUI [1,2]
    C0155877
    subjects having successfully completed one of the following protocols: cige025a011e3, cige025a2425, cige025aia05;
    Beschrijving

    subjects having successfully completed one of the following protocols: cige025a011e3, cige025a2425, cige025aia05;

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    elevated immunoglobin e levels
    Beschrijving

    IgE level

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2229760
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    significant systemic disease
    Beschrijving

    comorbidity

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    pregnancy or lactation
    Beschrijving

    pregnancy or lactation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
    Beschrijving

    lung disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0024115
    history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
    Beschrijving

    anaphylactoid or anaphylactic reaction

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0340865
    UMLS CUI [2]
    C0002792
    current treatment with warfarin (coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.
    Beschrijving

    warfarin immunomodulatory therapy or antiplatelet therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0043031
    UMLS CUI [2]
    C1963758
    UMLS CUI [3]
    C1096021

    Similar models

    Eligibility Asthma NCT00639691

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00639691
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    male or female, ≥ 6years of age;
    boolean
    C0001779 (UMLS CUI [1])
    allergic asthma
    Item
    who have a diagnosis of allergic asthma ≥ 1 year duration according to american thoracic society (ats) criteria;
    boolean
    C0155877 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    severe persistent allergic asthma
    Item
    severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per canadian asthma consensus report (1999));
    boolean
    C1960048 (UMLS CUI [1,1])
    C0155877 (UMLS CUI [1,2])
    subjects having successfully completed one of the following protocols: cige025a011e3, cige025a2425, cige025aia05;
    Item
    subjects having successfully completed one of the following protocols: cige025a011e3, cige025a2425, cige025aia05;
    boolean
    C2348568 (UMLS CUI [1])
    IgE level
    Item
    elevated immunoglobin e levels
    boolean
    C2229760 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    comorbidity
    Item
    significant systemic disease
    boolean
    C0009488 (UMLS CUI [1])
    pregnancy or lactation
    Item
    pregnancy or lactation
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    lung disease
    Item
    an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
    boolean
    C0024115 (UMLS CUI [1])
    anaphylactoid or anaphylactic reaction
    Item
    history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
    boolean
    C0340865 (UMLS CUI [1])
    C0002792 (UMLS CUI [2])
    warfarin immunomodulatory therapy or antiplatelet therapy
    Item
    current treatment with warfarin (coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.
    boolean
    C0043031 (UMLS CUI [1])
    C1963758 (UMLS CUI [2])
    C1096021 (UMLS CUI [3])

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