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ID

14497

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02264691

Trefwoorden

Versies (1)
  1. 18-04-16 18-04-16 -
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18 april 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Asthma NCT02264691

    Engels

    Eligibility Asthma NCT02264691

    1 Formulieren  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02264691
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    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.
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1708335 (Healthy Volunteers)
    UMLS CUI [2]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [3]
    C0024115 (Lung diseases)
    SNOMED
    19829001
    UMLS CUI [4]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    UMLS CUI [5]
    C1287681 (Forced vital capacity - finding)
    SNOMED
    366151006
    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.
    Beschrijving

    Asthma | Reversibility FEV1 | Methacholine

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [2,1]
    C0449261 (Reversibility)
    SNOMED
    263508009
    UMLS CUI [2,2]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    UMLS CUI [3]
    C0600370 (methacholine)
    SNOMED
    53584007
    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.
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0581124 (Mild asthma)
    SNOMED
    370218001
    UMLS CUI [2]
    C0038317 (Steroids)
    SNOMED
    768759001
    LOINC
    LP20784-2
    UMLS CUI [3]
    C2936789 (Adrenergic beta-2 Receptor Agonists)
    UMLS CUI [4]
    C0595726 (Leukotriene Antagonists)
    SNOMED
    372517002
    UMLS CUI [5]
    C2065041 (inhaled steroids)
    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.
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1960046 (Mild persistent asthma)
    SNOMED
    426979002
    UMLS CUI [2]
    C1960047 (Moderate persistent asthma)
    SNOMED
    427295004
    UMLS CUI [3]
    C2065041 (inhaled steroids)
    UMLS CUI [4]
    C0082607 (fluticasone)
    SNOMED
    108632003
    UMLS CUI [5]
    C2936789 (Adrenergic beta-2 Receptor Agonists)
    severe asthma (sa) will be defined according to the ats criteria for refractory asthma (10)
    Beschrijving

    Severe asthma

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0581126 (Severe asthma)
    SNOMED
    370221004
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    exclusion criteria apply for all subjects:
    Beschrijving

    Exclusion Criteria

    Datatype

    boolean

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

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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3241966 (Current Smoker)
    UMLS CUI [2,1]
    C0337671 (Former smoker)
    SNOMED
    8517006
    LOINC
    LA15920-4
    UMLS CUI [2,2]
    C2230126 (smoking cigarettes: ____ pack-years history)
    UMLS CUI [3]
    C0748223 (QUIT)
    asthma exacerbation, requiring a new or increased dose of oral corticosteroids, within the past 30 days
    Beschrijving

    Exacerbation of asthma | Adrenal Cortex Hormones

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0349790 (Exacerbation of asthma)
    SNOMED
    281239006
    UMLS CUI [2]
    C0001617 (Adrenal Cortex Hormones)
    SNOMED
    21568003
    LOINC
    LP20687-7
    pregnant or lactating female
    Beschrijving

    Pregnancy | Breast Feeding

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    significant/uncontrolled medical condition (uncontrolled diabetes, coronary artery disease, uncontrolled hypertension)
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [2]
    C0421258 (Diabetic - poor control)
    SNOMED
    268519009
    UMLS CUI [3]
    C1956346 (Coronary Artery Disease)
    SNOMED
    53741008
    UMLS CUI [4]
    C1868885 (Uncontrolled hypertension)
    diagnosis of emphysema or other significant pulmonary disease
    Beschrijving

    Pulmonary Emphysema | Lung diseases

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0034067 (Pulmonary Emphysema)
    SNOMED
    87433001
    LOINC
    LA10561-1
    UMLS CUI [2]
    C0024115 (Lung diseases)
    SNOMED
    19829001
    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.
    Beschrijving

    Comorbidity | Bronchoscopy Compliance behavior Limited

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    UMLS CUI [2,1]
    C0006290 (Bronchoscopy)
    SNOMED
    10847001
    LOINC
    LP6158-2
    UMLS CUI [2,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [2,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
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    Similar models

    Eligibility Asthma NCT02264691

    1 Formulieren
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02264691
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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