0 Avaliações
ID

32358

Descrição

Correlation Between IgE Parameters and the Response to Omalizumab in Subjects With Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01002976

Link

https://clinicaltrials.gov/show/NCT01002976

Palavras-chave

Versões (1)
  1. 27/10/2018 27/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Severe Allergic Asthma NCT01002976

    Inglês

    Eligibility Severe Allergic Asthma NCT01002976

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects who (or as appropriate whose legal guardian) have been informed of the study procedures and medications and have given their written informed consent
    Descrição

    Informed Consent | Informed Consent Legal Guardian

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0023226
    subjects with severe allergic asthma that based on standard practice have been assigned to omalizumab treatment and fulfill all requirements for such treatment
    Descrição

    Allergic asthma Severe | omalizumab | Treatment Requirement Fulfill

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0155877
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C0966225
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C1550543
    the requirements include:
    Descrição

    Requirement Included

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1514873
    UMLS CUI [1,2]
    C0332257
    uncontrolled severe asthma despite maximal and optimal therapy , gina stage iv
    Descrição

    Severe asthma Uncontrolled | Therapy Optimal Maximal | Initiative Global Asthma Stage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0581126
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C2698651
    UMLS CUI [2,3]
    C0205289
    UMLS CUI [3,1]
    C0424093
    UMLS CUI [3,2]
    C2348867
    UMLS CUI [3,3]
    C0004096
    UMLS CUI [3,4]
    C1306673
    reversible airway obstruction ( a change of 12% of fev1 after bronchodilator inhalation)
    Descrição

    Airway Obstruction Reversible | Change Percentage FEV1 Post bronchodilator

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001883
    UMLS CUI [1,2]
    C0205343
    UMLS CUI [2,1]
    C0392747
    UMLS CUI [2,2]
    C0439165
    UMLS CUI [2,3]
    C0849974
    UMLS CUI [2,4]
    C2599594
    non smoking or smoking less then 10 py.
    Descrição

    Non-smoker | Tobacco use Smoking cigarettes: ____ pack-years history

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0337672
    UMLS CUI [2,1]
    C0543414
    UMLS CUI [2,2]
    C2230126
    positive skin test or rast test for relevant allergen
    Descrição

    Allergen skin test positive | RAST positive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0855854
    UMLS CUI [2]
    C0855586
    ige blood level between 30-700 iu and
    Descrição

    Blood immunoglobulin E

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0853329
    two or more asthma exacerbation needed systemic steroids treatment during the last twelve months or continuing systemic steroid treatment. or
    Descrição

    Exacerbation of asthma Quantity | Systemic steroids Required | Systemic steroids Continuing therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0349790
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [2,1]
    C2825233
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [3,1]
    C2825233
    UMLS CUI [3,2]
    C1553904
    contraindication to systemic steroid treatment due to side effects, such as osteoporosis and uncontrolled diabetes.
    Descrição

    Medical contraindication Systemic steroids | Etiology Side effects | Osteoporosis | Diabetic - poor control

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C2825233
    UMLS CUI [2,1]
    C0015127
    UMLS CUI [2,2]
    C0879626
    UMLS CUI [3]
    C0029456
    UMLS CUI [4]
    C0421258
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    pregnancy or nursing mothers
    Descrição

    Pregnancy | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    subject who have experienced a severe hypersensitivity reaction to xolair®
    Descrição

    Severe allergy Xolair

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2945656
    UMLS CUI [1,2]
    C1174773
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    Similar models

    Eligibility Severe Allergic Asthma NCT01002976

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent | Informed Consent Legal Guardian
    Item
    subjects who (or as appropriate whose legal guardian) have been informed of the study procedures and medications and have given their written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    C0021430 (UMLS CUI [2,1])
    C0023226 (UMLS CUI [2,2])
    Allergic asthma Severe | omalizumab | Treatment Requirement Fulfill
    Item
    subjects with severe allergic asthma that based on standard practice have been assigned to omalizumab treatment and fulfill all requirements for such treatment
    boolean
    C0155877 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0966225 (UMLS CUI [2])
    C0087111 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C1550543 (UMLS CUI [3,3])
    Requirement Included
    Item
    the requirements include:
    boolean
    C1514873 (UMLS CUI [1,1])
    C0332257 (UMLS CUI [1,2])
    Severe asthma Uncontrolled | Therapy Optimal Maximal | Initiative Global Asthma Stage
    Item
    uncontrolled severe asthma despite maximal and optimal therapy , gina stage iv
    boolean
    C0581126 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C2698651 (UMLS CUI [2,2])
    C0205289 (UMLS CUI [2,3])
    C0424093 (UMLS CUI [3,1])
    C2348867 (UMLS CUI [3,2])
    C0004096 (UMLS CUI [3,3])
    C1306673 (UMLS CUI [3,4])
    Airway Obstruction Reversible | Change Percentage FEV1 Post bronchodilator
    Item
    reversible airway obstruction ( a change of 12% of fev1 after bronchodilator inhalation)
    boolean
    C0001883 (UMLS CUI [1,1])
    C0205343 (UMLS CUI [1,2])
    C0392747 (UMLS CUI [2,1])
    C0439165 (UMLS CUI [2,2])
    C0849974 (UMLS CUI [2,3])
    C2599594 (UMLS CUI [2,4])
    Non-smoker | Tobacco use Smoking cigarettes: ____ pack-years history
    Item
    non smoking or smoking less then 10 py.
    boolean
    C0337672 (UMLS CUI [1])
    C0543414 (UMLS CUI [2,1])
    C2230126 (UMLS CUI [2,2])
    Allergen skin test positive | RAST positive
    Item
    positive skin test or rast test for relevant allergen
    boolean
    C0855854 (UMLS CUI [1])
    C0855586 (UMLS CUI [2])
    Blood immunoglobulin E
    Item
    ige blood level between 30-700 iu and
    boolean
    C0853329 (UMLS CUI [1])
    Exacerbation of asthma Quantity | Systemic steroids Required | Systemic steroids Continuing therapy
    Item
    two or more asthma exacerbation needed systemic steroids treatment during the last twelve months or continuing systemic steroid treatment. or
    boolean
    C0349790 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C2825233 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C2825233 (UMLS CUI [3,1])
    C1553904 (UMLS CUI [3,2])
    Medical contraindication Systemic steroids | Etiology Side effects | Osteoporosis | Diabetic - poor control
    Item
    contraindication to systemic steroid treatment due to side effects, such as osteoporosis and uncontrolled diabetes.
    boolean
    C1301624 (UMLS CUI [1,1])
    C2825233 (UMLS CUI [1,2])
    C0015127 (UMLS CUI [2,1])
    C0879626 (UMLS CUI [2,2])
    C0029456 (UMLS CUI [3])
    C0421258 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding
    Item
    pregnancy or nursing mothers
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Severe allergy Xolair
    Item
    subject who have experienced a severe hypersensitivity reaction to xolair®
    boolean
    C2945656 (UMLS CUI [1,1])
    C1174773 (UMLS CUI [1,2])
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