0 Ratings

ID

15612

Description

Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00151801

Link

https://clinicaltrials.gov/show/NCT00151801

Keywords

  1. 6/5/16 6/5/16 -
Uploaded on

June 5, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Multiple Sclerosis NCT00151801

    Eligibility Multiple Sclerosis NCT00151801

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    female patients
    Description

    female patients

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    clinically definite relapsing-remitting ms according to the mcdonald criteria
    Description

    relapsing-remitting ms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0751967 (Multiple Sclerosis, Relapsing-Remitting)
    SNOMED
    426373005
    age between 18-40 y.o.
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    edss from 0 to 4.0, inclusive
    Description

    edss

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    history of migraine or thromboembolic events
    Description

    migraine or thromboembolic events

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0149931 (Migraine Disorders)
    UMLS CUI [2]
    C0040053 (Thrombosis)
    SNOMED
    118927008
    LOINC
    LP31622-1
    reproductive system disorders
    Description

    reproductive system disorders

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0178829 (reproductive system disorder)
    SNOMED
    362968007
    pregnancy or suspension of pregnancy within 12 months prior to randomisation
    Description

    pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    prior use of estroprogestins within the last 3 months prior to randomisation
    Description

    estroprogestins

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015011 (ethinyl estradiol)
    SNOMED
    126097006
    prior use of immunosuppressive drugs within the last 12 months prior to randomisation
    Description

    immunosuppressive drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021081 (Immunosuppressive Agents)
    SNOMED
    69431002
    prior use of immunomodulating drugs within the last 6 months prior to randomisation
    Description

    immunomodulating drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005525 (Biological Response Modifiers)
    prior use of corticosteroids within the last 3 months prior to randomisation
    Description

    corticosteroids

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001617 (Adrenal Cortex Hormones)
    SNOMED
    21568003
    LOINC
    LP20687-7
    have clinical relapse 30 days prior to randomisation
    Description

    clinical relapse

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0856120 (Multiple sclerosis relapse)

    Similar models

    Eligibility Multiple Sclerosis NCT00151801

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    female patients
    Item
    female patients
    boolean
    C0079399 (UMLS CUI [1])
    relapsing-remitting ms
    Item
    clinically definite relapsing-remitting ms according to the mcdonald criteria
    boolean
    C0751967 (UMLS CUI [1])
    age
    Item
    age between 18-40 y.o.
    boolean
    C0001779 (UMLS CUI [1])
    edss
    Item
    edss from 0 to 4.0, inclusive
    boolean
    C0451246 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    migraine or thromboembolic events
    Item
    history of migraine or thromboembolic events
    boolean
    C0149931 (UMLS CUI [1])
    C0040053 (UMLS CUI [2])
    reproductive system disorders
    Item
    reproductive system disorders
    boolean
    C0178829 (UMLS CUI [1])
    pregnancy
    Item
    pregnancy or suspension of pregnancy within 12 months prior to randomisation
    boolean
    C0032961 (UMLS CUI [1])
    estroprogestins
    Item
    prior use of estroprogestins within the last 3 months prior to randomisation
    boolean
    C0015011 (UMLS CUI [1])
    immunosuppressive drugs
    Item
    prior use of immunosuppressive drugs within the last 12 months prior to randomisation
    boolean
    C0021081 (UMLS CUI [1])
    immunomodulating drugs
    Item
    prior use of immunomodulating drugs within the last 6 months prior to randomisation
    boolean
    C0005525 (UMLS CUI [1])
    corticosteroids
    Item
    prior use of corticosteroids within the last 3 months prior to randomisation
    boolean
    C0001617 (UMLS CUI [1])
    clinical relapse
    Item
    have clinical relapse 30 days prior to randomisation
    boolean
    C0856120 (UMLS CUI [1])

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