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ID

14273

Description

Asthma Intervention Research 2 (AIR2) Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00231114

Lien

https://clinicaltrials.gov/show/NCT00231114

Mots-clés

  1. 07/04/2016 07/04/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

7 de abril de 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    Eligibility Asthma NCT00231114

    Eligibility Asthma NCT00231114

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00231114
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subject is an adult between the ages of 18 to 65 years.
    Description

    age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    subject has asthma and is taking regular maintenance medication that includes inhaled corticosteroid (ics) and long acting ß2-agonist (laba).
    Description

    asthma, inhaled corticosteroid (ics) and long acting ß2-agonist (laba)

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    UMLS CUI [2]
    C3248292
    UMLS CUI [3,1]
    C2936789
    UMLS CUI [3,2]
    C0040223
    subject has a pre-bronchodilator forced expiratory volume in one second (fev1) of greater than or equal to 60% of predicted after medication stabilization during the baseline period.
    Description

    pre-bronchodilator fev1

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3172227
    subject has a pc20 < 8 mg/ml per methacholine inhalation test using standardized methods. pc20 is a provocative concentration of provocholine® (a brand of methacholine chloride) resulting in a drop of fev1 of 20% or more from baseline.
    Description

    pc20

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1714620
    subject has at least two days of asthma symptoms during the 4-weeks of the baseline diary period.
    Description

    asthma symptom frequency

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [1,3]
    C0439603
    subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
    Description

    smoking history

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1519384
    UMLS CUI [2]
    C1277691
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    subject has a post-bronchodilator fev1 of less than 65%.
    Description

    post-bronchodilator fev1

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0748133
    UMLS CUI [1,2]
    C2599594
    subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; or a history of life-threatening asthma, defined by past intubations for asthma, or icu admission for asthma within the prior 24 months.
    Description

    hospitalizations for exacerbations of asthma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019993
    UMLS CUI [2]
    C0349790
    UMLS CUI [3,1]
    C0004096
    UMLS CUI [3,2]
    C2826244
    subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
    Description

    recurrent lower respiratory tract infections

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0149725
    UMLS CUI [1,2]
    C2945760
    UMLS CUI [2,1]
    C1514873
    UMLS CUI [2,2]
    C0003232
    subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
    Description

    recurrent oral steroid use

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0574135
    UMLS CUI [1,2]
    C2945760
    subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
    Description

    sensitivity to medications required to perform bronchoscopy

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0023660
    UMLS CUI [1,3]
    C0004259
    UMLS CUI [1,4]
    C0005064
    subject has known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents.
    Description

    hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0079829
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0030512
    subject has other medical criteria.
    Description

    other medical criteria

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009488

    Similar models

    Eligibility Asthma NCT00231114

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00231114
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    subject is an adult between the ages of 18 to 65 years.
    boolean
    C0001779 (UMLS CUI [1])
    asthma, inhaled corticosteroid (ics) and long acting ß2-agonist (laba)
    Item
    subject has asthma and is taking regular maintenance medication that includes inhaled corticosteroid (ics) and long acting ß2-agonist (laba).
    boolean
    C0004096 (UMLS CUI [1])
    C3248292 (UMLS CUI [2])
    C2936789 (UMLS CUI [3,1])
    C0040223 (UMLS CUI [3,2])
    pre-bronchodilator fev1
    Item
    subject has a pre-bronchodilator forced expiratory volume in one second (fev1) of greater than or equal to 60% of predicted after medication stabilization during the baseline period.
    boolean
    C3172227 (UMLS CUI [1])
    pc20
    Item
    subject has a pc20 < 8 mg/ml per methacholine inhalation test using standardized methods. pc20 is a provocative concentration of provocholine® (a brand of methacholine chloride) resulting in a drop of fev1 of 20% or more from baseline.
    boolean
    C1714620 (UMLS CUI [1])
    asthma symptom frequency
    Item
    subject has at least two days of asthma symptoms during the 4-weeks of the baseline diary period.
    boolean
    C0004096 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0439603 (UMLS CUI [1,3])
    smoking history
    Item
    subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
    boolean
    C1519384 (UMLS CUI [1])
    C1277691 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    post-bronchodilator fev1
    Item
    subject has a post-bronchodilator fev1 of less than 65%.
    boolean
    C0748133 (UMLS CUI [1,1])
    C2599594 (UMLS CUI [1,2])
    hospitalizations for exacerbations of asthma
    Item
    subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; or a history of life-threatening asthma, defined by past intubations for asthma, or icu admission for asthma within the prior 24 months.
    boolean
    C0019993 (UMLS CUI [1])
    C0349790 (UMLS CUI [2])
    C0004096 (UMLS CUI [3,1])
    C2826244 (UMLS CUI [3,2])
    recurrent lower respiratory tract infections
    Item
    subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
    boolean
    C0149725 (UMLS CUI [1,1])
    C2945760 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [2,1])
    C0003232 (UMLS CUI [2,2])
    recurrent oral steroid use
    Item
    subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
    boolean
    C0574135 (UMLS CUI [1,1])
    C2945760 (UMLS CUI [1,2])
    sensitivity to medications required to perform bronchoscopy
    Item
    subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
    boolean
    C0020517 (UMLS CUI [1,1])
    C0023660 (UMLS CUI [1,2])
    C0004259 (UMLS CUI [1,3])
    C0005064 (UMLS CUI [1,4])
    hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents
    Item
    subject has known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0079829 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0030512 (UMLS CUI [2,2])
    other medical criteria
    Item
    subject has other medical criteria.
    boolean
    C0009488 (UMLS CUI [1])

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