ID

13246

Description

Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01422603

Link

https://clinicaltrials.gov/show/NCT01422603

Keywords

  1. 1/26/16 1/26/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 26, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    Eligibility Acute Myeloid Leukaemia NCT01422603

    Eligibility Acute Myeloid Leukaemia NCT01422603

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    cytologically and immunophenotypically (or immunohistochemically) confirmed diagnosis of high risk aml or mds
    Description

    AML or MDS

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    UMLS CUI [2]
    C3463824
    minimum age of 18 years
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    eligible for allogeneic stem cell transplant by local institutional guidelines
    Description

    stem cell transplant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1504389
    suitable matched-related/sibling or volunteer unrelated donor available, as determined by local institutional guidelines
    Description

    suitable matched-related/sibling or volunteer unrelated donor

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013018
    negative pregnancy test for females of child-bearing potential within 7 days prior to the start of study treatment
    Description

    pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    if sexually active, male and female subjects must agree that they will use an effective method of birth control throughout the active study period
    Description

    contraception

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    written informed consent
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    capable of and willing to comply with scheduled visits, treatment plan and required laboratory tests
    Description

    capable of and willing to comply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    adequate renal and hepatic function
    Description

    renal and hepatic function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0232741
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
    Description

    psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    previous allogeneic bone marrow or peripheral blood stem cell transplant.
    Description

    previous allogeneic bone marrow or peripheral blood stem cell transplant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005961
    UMLS CUI [2]
    C1504389
    pregnant or lactating women. all female subjects of child-bearing potential must have a negative pregnancy test within 7 days prior to the start of treatment.
    Description

    pregnancy or lactation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    any current active, invasive malignancy excluding aml or mds
    Description

    current active, invasive malignancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826

    Similar models

    Eligibility Acute Myeloid Leukaemia NCT01422603

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML or MDS
    Item
    cytologically and immunophenotypically (or immunohistochemically) confirmed diagnosis of high risk aml or mds
    boolean
    C0023467 (UMLS CUI [1])
    C3463824 (UMLS CUI [2])
    age
    Item
    minimum age of 18 years
    boolean
    C0001779 (UMLS CUI [1])
    stem cell transplant
    Item
    eligible for allogeneic stem cell transplant by local institutional guidelines
    boolean
    C1504389 (UMLS CUI [1])
    suitable matched-related/sibling or volunteer unrelated donor
    Item
    suitable matched-related/sibling or volunteer unrelated donor available, as determined by local institutional guidelines
    boolean
    C0013018 (UMLS CUI [1])
    pregnancy
    Item
    negative pregnancy test for females of child-bearing potential within 7 days prior to the start of study treatment
    boolean
    C0032961 (UMLS CUI [1])
    contraception
    Item
    if sexually active, male and female subjects must agree that they will use an effective method of birth control throughout the active study period
    boolean
    C0700589 (UMLS CUI [1])
    informed consent
    Item
    written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    capable of and willing to comply
    Item
    capable of and willing to comply with scheduled visits, treatment plan and required laboratory tests
    boolean
    C1321605 (UMLS CUI [1])
    renal and hepatic function
    Item
    adequate renal and hepatic function
    boolean
    C0232804 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
    Item
    psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
    boolean
    C0021430 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    previous allogeneic bone marrow or peripheral blood stem cell transplant
    Item
    previous allogeneic bone marrow or peripheral blood stem cell transplant.
    boolean
    C0005961 (UMLS CUI [1])
    C1504389 (UMLS CUI [2])
    pregnancy or lactation
    Item
    pregnant or lactating women. all female subjects of child-bearing potential must have a negative pregnancy test within 7 days prior to the start of treatment.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    current active, invasive malignancy
    Item
    any current active, invasive malignancy excluding aml or mds
    boolean
    C0006826 (UMLS CUI [1])

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