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ID

14001

Beschrijving

the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient; ODM derived from: https://clinicaltrials.gov/show/NCT01766375

Link

https://clinicaltrials.gov/show/NCT01766375

Trefwoorden

  1. 21-03-16 21-03-16 -
Geüploaded op

21 maart 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Acute Myeloid Leukemia NCT01766375

    Eligibility Acute Myeloid Leukemia NCT01766375

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    Age: 18~50
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Received peripheral blood hematopoietic stem cell transplantation from siblings or unrelated allogeneic donors with identical matching of hla or 1 alleles mismatched.
    Beschrijving

    Peripheral Stem Cell Transplantation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0242602 (Peripheral Stem Cell Transplantation)
    SNOMED
    278257006
    Diagnosis: refer to 2011 edition of aml china guideline for the diagnosis and treatment and diagnosis standards of high-risk acute myeloid leukemia developed through literatures (see appendix b);
    Beschrijving

    Acute Erythroblastic Leukemia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023440 (Acute Erythroblastic Leukemia)
    SNOMED
    14317002
    Under general condition, ecog score ≤ 1;
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Normal cardiac functions
    Beschrijving

    Cardiac function

    Datatype

    boolean

    Normal liver and renal function: blood bilirubin≤35 μ mol\/l, ast/alt lower than twice in the upper limit of normal value, serum creatinine≤ 150 μ mol\/l;
    Beschrijving

    Renal and Liver function

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [2]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    Subjects have signed the informed consent form.
    Beschrijving

    Informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    Severe uncontrolled infection before transplantation;
    Beschrijving

    Infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3714514 (Infection)
    LOINC
    LP130385-0
    With contraindications of idarubicin
    Beschrijving

    Idarubicin

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0020789 (idarubicin)
    SNOMED
    108786002
    Reached the maximum cumulative dose of anthracyclines, for instance, dnr≥ 450mg/m2, mitoxantrone≥140mg/m2, the total cumulative dose of idarubicin≥ 300mg/m2;
    Beschrijving

    Anthracycline Antibiotics

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0003234 (Anthracycline Antibiotics)
    SNOMED
    108787006
    The other conditions that do not meet the inclusion criteria.
    Beschrijving

    Inclusion criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2827031 (Trial Inclusion Exclusion Criteria Rule)
    Withdrawal criteria:
    Beschrijving

    Withdrawal

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2349954 (Withdraw (activity))

    Similar models

    Eligibility Acute Myeloid Leukemia NCT01766375

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    Age: 18~50
    boolean
    C0001779 (UMLS CUI [1])
    Peripheral Stem Cell Transplantation
    Item
    Received peripheral blood hematopoietic stem cell transplantation from siblings or unrelated allogeneic donors with identical matching of hla or 1 alleles mismatched.
    boolean
    C0242602 (UMLS CUI [1])
    Acute Erythroblastic Leukemia
    Item
    Diagnosis: refer to 2011 edition of aml china guideline for the diagnosis and treatment and diagnosis standards of high-risk acute myeloid leukemia developed through literatures (see appendix b);
    boolean
    C0023440 (UMLS CUI [1])
    ECOG performance status
    Item
    Under general condition, ecog score ≤ 1;
    boolean
    C1520224 (UMLS CUI [1])
    Cardiac function
    Item
    Normal cardiac functions
    boolean
    Renal and Liver function
    Item
    Normal liver and renal function: blood bilirubin≤35 μ mol\/l, ast/alt lower than twice in the upper limit of normal value, serum creatinine≤ 150 μ mol\/l;
    boolean
    C0232741 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    Informed consent
    Item
    Subjects have signed the informed consent form.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Infection
    Item
    Severe uncontrolled infection before transplantation;
    boolean
    C3714514 (UMLS CUI [1])
    Idarubicin
    Item
    With contraindications of idarubicin
    boolean
    C0020789 (UMLS CUI [1])
    Anthracycline Antibiotics
    Item
    Reached the maximum cumulative dose of anthracyclines, for instance, dnr≥ 450mg/m2, mitoxantrone≥140mg/m2, the total cumulative dose of idarubicin≥ 300mg/m2;
    boolean
    C0003234 (UMLS CUI [1])
    Inclusion criteria
    Item
    The other conditions that do not meet the inclusion criteria.
    boolean
    C2827031 (UMLS CUI [1])
    Item
    Withdrawal criteria:
    integer
    C2349954 (UMLS CUI [1])
    Code List
    Withdrawal criteria:
    CL Item
    Those do not meet the inclusion criteria or meet the exclusion criteria after reviewing (1)
    C2827031 (UMLS CUI-1)
    CL Item
    Patient withdraws the informed consent form (2)
    C0021430 (UMLS CUI-1)
    CL Item
    Patient violates the clinical study protocol (3)
    C2348563 (UMLS CUI-1)
    CL Item
    Patient experiences severe adverse events that treatment has to be terminated (4)
    C0877248 (UMLS CUI-1)
    CL Item
    Patient that considered no longer fit to complete clinical trials by researchers. (5)
    C0525058 (UMLS CUI-1)

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