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ID

14207

Beschrijving

Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205); ODM derived from: https://clinicaltrials.gov/show/NCT00163410

Link

https://clinicaltrials.gov/show/NCT00163410

Trefwoorden

  1. 04-04-16 04-04-16 -
  2. 05-04-16 05-04-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

4 april 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Eligibility Asthma NCT00163410

    Eligibility Asthma NCT00163410

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00163410
    Criteria
    Beschrijving

    Criteria

    history of persistent bronchial asthma for at least 6 months
    Beschrijving

    persistent asthma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3266628 (Persistent asthma)
    SNOMED
    5281000124103
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    fev1 50-90% of predicted
    Beschrijving

    fev1

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    main exclusion criteria:
    Beschrijving

    exclusion criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0680251 (Exclusion Criteria)
    concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
    Beschrijving

    comorbidity limiting use of inhaled steroids

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0586793 (Inhaled steroids use)
    SNOMED
    170659001
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    copd (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
    Beschrijving

    copd or other lung diseases

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    UMLS CUI [1,2]
    C0024115 (Lung diseases)
    SNOMED
    19829001
    respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
    Beschrijving

    asthma exacerbation or respiratory tract infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0349790 (Exacerbation of asthma)
    SNOMED
    281239006
    UMLS CUI [2,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [2,2]
    C0458827 (Airway structure)
    SNOMED
    89187006
    LOINC
    MTHU040120
    history of life-threatening asthma
    Beschrijving

    life-threatening asthma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [1,2]
    C2826244 (Life Threatening)
    premature birth
    Beschrijving

    premature birth

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0151526 (Premature Birth)
    SNOMED
    49550006
    LOINC
    LA9209-3
    current smoking
    Beschrijving

    current smoker

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3241966 (Current Smoker)
    smoking history with either equal or more than 10 pack-years
    Beschrijving

    smoking history

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519384 (Tobacco Smoking History)
    UMLS CUI [2]
    C1277691 (Pack years)
    SNOMED
    315609007
    pregnancy
    Beschrijving

    pregnancy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    intention to become pregnant during the course of the study
    Beschrijving

    intention to become pregnant

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,2]
    C1283828 (intent)
    SNOMED
    363703001
    breast feeding
    Beschrijving

    breast feeding

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    lack of safe contraception
    Beschrijving

    lack of safe contraception

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [1,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2

    Similar models

    Eligibility Asthma NCT00163410

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00163410
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    persistent asthma
    Item
    history of persistent bronchial asthma for at least 6 months
    boolean
    C3266628 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    fev1
    Item
    fev1 50-90% of predicted
    boolean
    C0748133 (UMLS CUI [1])
    exclusion criteria
    Item
    main exclusion criteria:
    boolean
    C0680251 (UMLS CUI [1])
    comorbidity limiting use of inhaled steroids
    Item
    concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
    boolean
    C0586793 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    copd or other lung diseases
    Item
    copd (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
    boolean
    C0024117 (UMLS CUI [1,1])
    C0024115 (UMLS CUI [1,2])
    asthma exacerbation or respiratory tract infection
    Item
    respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
    boolean
    C0349790 (UMLS CUI [1])
    C0009450 (UMLS CUI [2,1])
    C0458827 (UMLS CUI [2,2])
    life-threatening asthma
    Item
    history of life-threatening asthma
    boolean
    C0004096 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    premature birth
    Item
    premature birth
    boolean
    C0151526 (UMLS CUI [1])
    current smoker
    Item
    current smoking
    boolean
    C3241966 (UMLS CUI [1])
    smoking history
    Item
    smoking history with either equal or more than 10 pack-years
    boolean
    C1519384 (UMLS CUI [1])
    C1277691 (UMLS CUI [2])
    pregnancy
    Item
    pregnancy
    boolean
    C0032961 (UMLS CUI [1])
    intention to become pregnant
    Item
    intention to become pregnant during the course of the study
    boolean
    C0032961 (UMLS CUI [1,1])
    C1283828 (UMLS CUI [1,2])
    breast feeding
    Item
    breast feeding
    boolean
    C0006147 (UMLS CUI [1])
    lack of safe contraception
    Item
    lack of safe contraception
    boolean
    C0700589 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])

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