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ID

16283

Beskrivning

Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00093002

Länk

https://clinicaltrials.gov/show/NCT00093002

Nyckelord

  1. 2016-07-09 2016-07-09 -
Uppladdad den

9 juli 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT00093002

    Eligibility Breast Cancer NCT00093002

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    postmenopausal women defined as women who have stopped having menstrual periods
    Beskrivning

    postmenopausal women

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    written informed consent to participate in the trial
    Beskrivning

    written informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    biopsy confirmation of invasive breast cancer
    Beskrivning

    Biopsy result

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0405352 (Biopsy of breast)
    SNOMED
    122548005
    UMLS CUI [1,2]
    C0853879 (Invasive carcinoma of breast)
    SNOMED
    713609000
    evidence of hormone sensitivity
    Beskrivning

    Hormone status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0920555 (hormone sensitivity)
    willingness to undergo biopsies
    Beskrivning

    willingness to undergo biopsies

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C0405352 (Biopsy of breast)
    SNOMED
    122548005
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    any previous treatment for breast cancer
    Beskrivning

    previous treatment

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1511300 (Breast Cancer Therapeutic Procedure)
    unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
    Beskrivning

    ID.7

    Datatyp

    boolean

    any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
    Beskrivning

    Comorbidities

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    the presence of more than one primary tumor
    Beskrivning

    Number of primary tumors

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,2]
    C0677930 (Primary Neoplasm)
    history of hypersensitivity to castor oil
    Beskrivning

    hypersensitivity to castor oil

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0007343 (castor oil)
    SNOMED
    774188002
    history of known bleeding disorders
    Beskrivning

    bleeding disorders

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005779 (Blood Coagulation Disorders)
    SNOMED
    64779008

    Similar models

    Eligibility Breast Cancer NCT00093002

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    postmenopausal women
    Item
    postmenopausal women defined as women who have stopped having menstrual periods
    boolean
    C0232970 (UMLS CUI [1])
    written informed consent
    Item
    written informed consent to participate in the trial
    boolean
    C0021430 (UMLS CUI [1])
    Biopsy result
    Item
    biopsy confirmation of invasive breast cancer
    boolean
    C0405352 (UMLS CUI [1,1])
    C0853879 (UMLS CUI [1,2])
    Hormone status
    Item
    evidence of hormone sensitivity
    boolean
    C0920555 (UMLS CUI [1])
    willingness to undergo biopsies
    Item
    willingness to undergo biopsies
    boolean
    C0021430 (UMLS CUI [1,1])
    C0405352 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    previous treatment
    Item
    any previous treatment for breast cancer
    boolean
    C1511300 (UMLS CUI [1])
    ID.7
    Item
    unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
    boolean
    Comorbidities
    Item
    any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
    boolean
    C0009488 (UMLS CUI [1])
    Number of primary tumors
    Item
    the presence of more than one primary tumor
    boolean
    C0449788 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    hypersensitivity to castor oil
    Item
    history of hypersensitivity to castor oil
    boolean
    C0020517 (UMLS CUI [1,1])
    C0007343 (UMLS CUI [1,2])
    bleeding disorders
    Item
    history of known bleeding disorders
    boolean
    C0005779 (UMLS CUI [1])

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