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ID

14358

Beskrivning

SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII); ODM derived from: https://clinicaltrials.gov/show/NCT00455923

Länk

https://clinicaltrials.gov/show/NCT00455923

Nyckelord

  1. 2016-04-12 2016-04-12 -
Uppladdad den

12 april 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Asthma NCT00455923

    Eligibility Asthma NCT00455923

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00455923
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    willing to give informed consent.
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    males or females aged 18-70.
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    able to understand and complete dairy cards.
    Beskrivning

    able to understand and complete dairy cards

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    mild persistent asthma according to gina. in addition, at randomisation subjects were required to have: 1. day time symptoms more than once a week but not every day. 2. night-time symptoms not more than once a week. 3. fev1 >80% predicted 4. pc20 <8mg/ml
    Beskrivning

    mild persistent asthma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1960046
    UMLS CUI [2]
    C0748133
    UMLS CUI [3]
    C1714620
    UMLS CUI [4,1]
    C1276804
    UMLS CUI [4,2]
    C0436350
    UMLS CUI [5,1]
    C2957235
    UMLS CUI [5,2]
    C0436350
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    change to regular asthma medication in 4-weeks prior to visit 1.
    Beskrivning

    asthma medication change

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0004096
    UMLS CUI [1,3]
    C0580105
    UMLS CUI [1,4]
    C0040223
    use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
    Beskrivning

    corticosteroids

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0001617
    UMLS CUI [1,2]
    C0040223
    lower respiratory tract within 4 weeks of visit 1
    Beskrivning

    lower respiratory tract infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0149725
    received investigational study drug within 4 weeks of visit
    Beskrivning

    investigational drug

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    smoking history of >10 pack years of more.
    Beskrivning

    smoking history

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519384
    UMLS CUI [1,2]
    C1277691
    serious uncontrolled disease.
    Beskrivning

    serious uncontrolled disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    medical conditions or medications known to affect the assessments or endpoints.
    Beskrivning

    comorbidity limiting study protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    evidence of alcohol or drug abuse.
    Beskrivning

    alcohol or drug abuse

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    known pregnancy or planned pregnancy.
    Beskrivning

    pregnancy or planned pregnancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C0032961
    UMLS CUI [2,2]
    C1283828
    known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
    Beskrivning

    hypersensitivity to inhaled corticosteroids, beta-agonists or lactose

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C2065041
    UMLS CUI [1,3]
    C0001644
    UMLS CUI [1,4]
    C0022949
    previous enrollment in the study
    Beskrivning

    previous enrollment in the study

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568

    Similar models

    Eligibility Asthma NCT00455923

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00455923
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    informed consent
    Item
    willing to give informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    age
    Item
    males or females aged 18-70.
    boolean
    C0001779 (UMLS CUI [1])
    able to understand and complete dairy cards
    Item
    able to understand and complete dairy cards.
    boolean
    C1321605 (UMLS CUI [1])
    mild persistent asthma
    Item
    mild persistent asthma according to gina. in addition, at randomisation subjects were required to have: 1. day time symptoms more than once a week but not every day. 2. night-time symptoms not more than once a week. 3. fev1 >80% predicted 4. pc20 <8mg/ml
    boolean
    C1960046 (UMLS CUI [1])
    C0748133 (UMLS CUI [2])
    C1714620 (UMLS CUI [3])
    C1276804 (UMLS CUI [4,1])
    C0436350 (UMLS CUI [4,2])
    C2957235 (UMLS CUI [5,1])
    C0436350 (UMLS CUI [5,2])
    Item Group
    C0680251 (UMLS CUI)
    asthma medication change
    Item
    change to regular asthma medication in 4-weeks prior to visit 1.
    boolean
    C0013227 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    C0580105 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    corticosteroids
    Item
    use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
    boolean
    C0001617 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    lower respiratory tract infection
    Item
    lower respiratory tract within 4 weeks of visit 1
    boolean
    C0149725 (UMLS CUI [1])
    investigational drug
    Item
    received investigational study drug within 4 weeks of visit
    boolean
    C0013230 (UMLS CUI [1])
    smoking history
    Item
    smoking history of >10 pack years of more.
    boolean
    C1519384 (UMLS CUI [1,1])
    C1277691 (UMLS CUI [1,2])
    serious uncontrolled disease
    Item
    serious uncontrolled disease.
    boolean
    C0009488 (UMLS CUI [1])
    comorbidity limiting study protocol
    Item
    medical conditions or medications known to affect the assessments or endpoints.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    alcohol or drug abuse
    Item
    evidence of alcohol or drug abuse.
    boolean
    C0038586 (UMLS CUI [1])
    pregnancy or planned pregnancy
    Item
    known pregnancy or planned pregnancy.
    boolean
    C0032961 (UMLS CUI [1])
    C0032961 (UMLS CUI [2,1])
    C1283828 (UMLS CUI [2,2])
    hypersensitivity to inhaled corticosteroids, beta-agonists or lactose
    Item
    known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
    boolean
    C0020517 (UMLS CUI [1,1])
    C2065041 (UMLS CUI [1,2])
    C0001644 (UMLS CUI [1,3])
    C0022949 (UMLS CUI [1,4])
    previous enrollment in the study
    Item
    previous enrollment in the study
    boolean
    C2348568 (UMLS CUI [1])

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