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ID

14497

Beskrivning

UTMB Research on Severe Asthma (UROSA) Study; ODM derived from: https://clinicaltrials.gov/show/NCT02264691

Länk

https://clinicaltrials.gov/show/NCT02264691

Nyckelord

Versioner (1)
  1. 2016-04-18 2016-04-18 -
Uppladdad den

18 april 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Asthma NCT02264691

    Engelsk

    Eligibility Asthma NCT02264691

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02264691
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    all participants must be in good general health (with exception to asthma). • normal controls / healthy volunteers (nc) subjects with no past history of asthma or other lung disease. to determine this, subjects must have an fev1 equal to or greater than 80% of predicted value and have a normal fev1/fvc ratio.
    Beskrivning

    Healthy Volunteers | Asthma | Lung diseases | FEV1 | Forced vital capacity - finding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1708335
    UMLS CUI [2]
    C0004096
    UMLS CUI [3]
    C0024115
    UMLS CUI [4]
    C0748133
    UMLS CUI [5]
    C1287681
    asthma subjects eligible asthmatic participants must have a physician diagnosis of asthma for at least 1 year. participants must either have historical evidence of reversibility of fev1 of at least 12%, or demonstrate such a change during the study visits, or must have historical evidence of a pc20 for methacholine < 8mg/ml.
    Beskrivning

    Asthma | Reversibility FEV1 | Methacholine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    UMLS CUI [2,1]
    C0449261
    UMLS CUI [2,2]
    C0748133
    UMLS CUI [3]
    C0600370
    mild asthma with no corticosteroids (manc) will be defined as control of asthma with short acting β2-agonists or leukotrine antagonist or both, but not requiring inhaled corticosteroids.
    Beskrivning

    Mild asthma | Steroids | Adrenergic beta-2 Receptor Agonists | Leukotriene Antagonists | inhaled steroids

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0581124
    UMLS CUI [2]
    C0038317
    UMLS CUI [3]
    C2936789
    UMLS CUI [4]
    C0595726
    UMLS CUI [5]
    C2065041
    mild to moderate asthma (mma) will be defined as control of asthma with an inhaled corticosteroid (less than or equal to 250 mcg daily inhaled fluticasone equivalent) in addition to the medications listed in the manc group or long acting β2-agonists.
    Beskrivning

    Mild persistent asthma | Moderate persistent asthma | inhaled steroids | fluticasone | Adrenergic beta-2 Receptor Agonists

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1960046
    UMLS CUI [2]
    C1960047
    UMLS CUI [3]
    C2065041
    UMLS CUI [4]
    C0082607
    UMLS CUI [5]
    C2936789
    severe asthma (sa) will be defined according to the ats criteria for refractory asthma (10)
    Beskrivning

    Severe asthma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0581126
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    exclusion criteria apply for all subjects:
    Beskrivning

    Exclusion Criteria

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    current smoker, or former smoker with >10 pack years history or having quit within the past year
    Beskrivning

    Current Smoker | Former smoker Smoking cigarettes: ____ pack-years history | QUIT

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3241966
    UMLS CUI [2,1]
    C0337671
    UMLS CUI [2,2]
    C2230126
    UMLS CUI [3]
    C0748223
    asthma exacerbation, requiring a new or increased dose of oral corticosteroids, within the past 30 days
    Beskrivning

    Exacerbation of asthma | Adrenal Cortex Hormones

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0349790
    UMLS CUI [2]
    C0001617
    pregnant or lactating female
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    significant/uncontrolled medical condition (uncontrolled diabetes, coronary artery disease, uncontrolled hypertension)
    Beskrivning

    Disease Uncontrolled | Diabetic - poor control | Coronary Artery Disease | Uncontrolled hypertension

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C0421258
    UMLS CUI [3]
    C1956346
    UMLS CUI [4]
    C1868885
    diagnosis of emphysema or other significant pulmonary disease
    Beskrivning

    Pulmonary Emphysema | Lung diseases

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0034067
    UMLS CUI [2]
    C0024115
    if, in the opinion of the pi (wjc) the subject has co-morbid conditions that make them unsafe to undergo bronchoscopy, subjects will be given the choice to withdraw from the study or allowed to complete visits 1-3 only.
    Beskrivning

    Comorbidity | Bronchoscopy Compliance behavior Limited

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2,1]
    C0006290
    UMLS CUI [2,2]
    C1321605
    UMLS CUI [2,3]
    C0439801
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    Similar models

    Eligibility Asthma NCT02264691

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02264691
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Healthy Volunteers | Asthma | Lung diseases | FEV1 | Forced vital capacity - finding
    Item
    all participants must be in good general health (with exception to asthma). • normal controls / healthy volunteers (nc) subjects with no past history of asthma or other lung disease. to determine this, subjects must have an fev1 equal to or greater than 80% of predicted value and have a normal fev1/fvc ratio.
    boolean
    C1708335 (UMLS CUI [1])
    C0004096 (UMLS CUI [2])
    C0024115 (UMLS CUI [3])
    C0748133 (UMLS CUI [4])
    C1287681 (UMLS CUI [5])
    Asthma | Reversibility FEV1 | Methacholine
    Item
    asthma subjects eligible asthmatic participants must have a physician diagnosis of asthma for at least 1 year. participants must either have historical evidence of reversibility of fev1 of at least 12%, or demonstrate such a change during the study visits, or must have historical evidence of a pc20 for methacholine < 8mg/ml.
    boolean
    C0004096 (UMLS CUI [1])
    C0449261 (UMLS CUI [2,1])
    C0748133 (UMLS CUI [2,2])
    C0600370 (UMLS CUI [3])
    Mild asthma | Steroids | Adrenergic beta-2 Receptor Agonists | Leukotriene Antagonists | inhaled steroids
    Item
    mild asthma with no corticosteroids (manc) will be defined as control of asthma with short acting β2-agonists or leukotrine antagonist or both, but not requiring inhaled corticosteroids.
    boolean
    C0581124 (UMLS CUI [1])
    C0038317 (UMLS CUI [2])
    C2936789 (UMLS CUI [3])
    C0595726 (UMLS CUI [4])
    C2065041 (UMLS CUI [5])
    Mild persistent asthma | Moderate persistent asthma | inhaled steroids | fluticasone | Adrenergic beta-2 Receptor Agonists
    Item
    mild to moderate asthma (mma) will be defined as control of asthma with an inhaled corticosteroid (less than or equal to 250 mcg daily inhaled fluticasone equivalent) in addition to the medications listed in the manc group or long acting β2-agonists.
    boolean
    C1960046 (UMLS CUI [1])
    C1960047 (UMLS CUI [2])
    C2065041 (UMLS CUI [3])
    C0082607 (UMLS CUI [4])
    C2936789 (UMLS CUI [5])
    Severe asthma
    Item
    severe asthma (sa) will be defined according to the ats criteria for refractory asthma (10)
    boolean
    C0581126 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Exclusion Criteria
    Item
    exclusion criteria apply for all subjects:
    boolean
    C0680251 (UMLS CUI [1])
    Current Smoker | Former smoker Smoking cigarettes: ____ pack-years history | QUIT
    Item
    current smoker, or former smoker with >10 pack years history or having quit within the past year
    boolean
    C3241966 (UMLS CUI [1])
    C0337671 (UMLS CUI [2,1])
    C2230126 (UMLS CUI [2,2])
    C0748223 (UMLS CUI [3])
    Exacerbation of asthma | Adrenal Cortex Hormones
    Item
    asthma exacerbation, requiring a new or increased dose of oral corticosteroids, within the past 30 days
    boolean
    C0349790 (UMLS CUI [1])
    C0001617 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating female
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Disease Uncontrolled | Diabetic - poor control | Coronary Artery Disease | Uncontrolled hypertension
    Item
    significant/uncontrolled medical condition (uncontrolled diabetes, coronary artery disease, uncontrolled hypertension)
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0421258 (UMLS CUI [2])
    C1956346 (UMLS CUI [3])
    C1868885 (UMLS CUI [4])
    Pulmonary Emphysema | Lung diseases
    Item
    diagnosis of emphysema or other significant pulmonary disease
    boolean
    C0034067 (UMLS CUI [1])
    C0024115 (UMLS CUI [2])
    Comorbidity | Bronchoscopy Compliance behavior Limited
    Item
    if, in the opinion of the pi (wjc) the subject has co-morbid conditions that make them unsafe to undergo bronchoscopy, subjects will be given the choice to withdraw from the study or allowed to complete visits 1-3 only.
    boolean
    C0009488 (UMLS CUI [1])
    C0006290 (UMLS CUI [2,1])
    C1321605 (UMLS CUI [2,2])
    C0439801 (UMLS CUI [2,3])
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