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ID

14522

Beschreibung

Vitamin D for the Treatment of Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00712205

Link

https://clinicaltrials.gov/show/NCT00712205

Stichworte

  1. 19.04.16 19.04.16 -
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CC BY-NC 3.0

Hochgeladen am

19. April 2016

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Creative Commons BY-NC 3.0

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    Eligibility Asthma NCT00712205

    Eligibility Asthma NCT00712205

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00712205
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    20 outpatients of either sex,
    Beschreibung

    outpatients

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0029921
    ages ≥18 years, with a history of persistent asthma as defined by the american thoracic society (ats) will be eligible for entry into the study.
    Beschreibung

    age and persistent asthma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C3266628
    additionally, patients must have been previously treated with ics for at least 4 weeks at a stable dose equivalent to ≥400 ug/day beclomethasone dipropionate.
    Beschreibung

    ics treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3248292
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [2]
    C0004906
    patients will be required to have a forced expiratory volume in 1 s (fev1) between 40-85% of predicted normal before the use of an inhaled bronchodilator and to demonstrate at least one of the following:
    Beschreibung

    pre-bronchodilator fev1

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3172227
    an improvement in fev1 ≥ 12% and ≥ 200 ml within 15-30 min after inhalation of salbutamol 200-400 ug;
    Beschreibung

    post-bronchodilator fev1

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0748133
    UMLS CUI [1,2]
    C2599594
    UMLS CUI [1,3]
    C0001927
    airway hyperresponsiveness to methacholine causing a 20% decline in fev1 (pc20 fev1) at a concentration of < 16 mg/ml;
    Beschreibung

    methacholine challenge

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0430567
    UMLS CUI [1,2]
    C0748133
    diurnal peak expiratory flow (pef) variability of ≥ 15% during at least 3 of 7 days before randomization.
    Beschreibung

    pef variability

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030735
    UMLS CUI [1,2]
    C2827666
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with either an exacerbation of asthma or respiratory tract infection within 6 weeks or admission to a hospital for asthma within 6 weeks before the study will be excluded.
    Beschreibung

    asthma exacerbation or respiratory tract infection or hospitalization for asthma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0349790
    UMLS CUI [2,1]
    C0009450
    UMLS CUI [2,2]
    C0458827
    UMLS CUI [3,1]
    C0019993
    UMLS CUI [3,2]
    C0004096
    UMLS CUI [4]
    C0040223
    also patients will not be eligible if they had > 3 nights with awakenings due to asthma that required treatment with short-acting betamimetics or had 3 days when they required > or = 12 puffs/d short-acting betamimetics during the 7days before the randomization visits.
    Beschreibung

    nighttime symptoms and beta-2 agonists

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1273489
    UMLS CUI [1,2]
    C0860510
    UMLS CUI [2]
    C1373132
    patients will also excluded if they use medications greater potency than inhaled steroid, e.g.not leukotriene inhibitors or anti-ige (xolair®).
    Beschreibung

    potency greater than inhaled steroid

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2065041
    UMLS CUI [1,2]
    C0678792
    patients with chronic obstructive pulmonary disease and current or former smokers of >10 pack-years
    Beschreibung

    copd and smoking history

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0024117
    UMLS CUI [2]
    C1519384
    UMLS CUI [3]
    C1277691

    Ähnliche Modelle

    Eligibility Asthma NCT00712205

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00712205
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    outpatients
    Item
    20 outpatients of either sex,
    boolean
    C0029921 (UMLS CUI [1])
    age and persistent asthma
    Item
    ages ≥18 years, with a history of persistent asthma as defined by the american thoracic society (ats) will be eligible for entry into the study.
    boolean
    C0001779 (UMLS CUI [1])
    C3266628 (UMLS CUI [2])
    ics treatment
    Item
    additionally, patients must have been previously treated with ics for at least 4 weeks at a stable dose equivalent to ≥400 ug/day beclomethasone dipropionate.
    boolean
    C3248292 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0004906 (UMLS CUI [2])
    pre-bronchodilator fev1
    Item
    patients will be required to have a forced expiratory volume in 1 s (fev1) between 40-85% of predicted normal before the use of an inhaled bronchodilator and to demonstrate at least one of the following:
    boolean
    C3172227 (UMLS CUI [1])
    post-bronchodilator fev1
    Item
    an improvement in fev1 ≥ 12% and ≥ 200 ml within 15-30 min after inhalation of salbutamol 200-400 ug;
    boolean
    C0748133 (UMLS CUI [1,1])
    C2599594 (UMLS CUI [1,2])
    C0001927 (UMLS CUI [1,3])
    methacholine challenge
    Item
    airway hyperresponsiveness to methacholine causing a 20% decline in fev1 (pc20 fev1) at a concentration of < 16 mg/ml;
    boolean
    C0430567 (UMLS CUI [1,1])
    C0748133 (UMLS CUI [1,2])
    pef variability
    Item
    diurnal peak expiratory flow (pef) variability of ≥ 15% during at least 3 of 7 days before randomization.
    boolean
    C0030735 (UMLS CUI [1,1])
    C2827666 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    asthma exacerbation or respiratory tract infection or hospitalization for asthma
    Item
    patients with either an exacerbation of asthma or respiratory tract infection within 6 weeks or admission to a hospital for asthma within 6 weeks before the study will be excluded.
    boolean
    C0349790 (UMLS CUI [1])
    C0009450 (UMLS CUI [2,1])
    C0458827 (UMLS CUI [2,2])
    C0019993 (UMLS CUI [3,1])
    C0004096 (UMLS CUI [3,2])
    C0040223 (UMLS CUI [4])
    nighttime symptoms and beta-2 agonists
    Item
    also patients will not be eligible if they had > 3 nights with awakenings due to asthma that required treatment with short-acting betamimetics or had 3 days when they required > or = 12 puffs/d short-acting betamimetics during the 7days before the randomization visits.
    boolean
    C1273489 (UMLS CUI [1,1])
    C0860510 (UMLS CUI [1,2])
    C1373132 (UMLS CUI [2])
    potency greater than inhaled steroid
    Item
    patients will also excluded if they use medications greater potency than inhaled steroid, e.g.not leukotriene inhibitors or anti-ige (xolair®).
    boolean
    C2065041 (UMLS CUI [1,1])
    C0678792 (UMLS CUI [1,2])
    copd and smoking history
    Item
    patients with chronic obstructive pulmonary disease and current or former smokers of >10 pack-years
    boolean
    C0024117 (UMLS CUI [1])
    C1519384 (UMLS CUI [2])
    C1277691 (UMLS CUI [3])

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