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ID

14004

Beschrijving

Idarubicin Overcomes MDR1 Induced Chemoresistance With Higher Induction Remission Rate and Quality Than Daunorubicin in Acute Myeloid Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01889407

Link

https://clinicaltrials.gov/show/NCT01889407

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 NCT01889407

    Eligibility Acute Myeloid Leukemia NCT01889407

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Diagnosis of aml (who classification definition of >/= 20% blasts).
    Beschrijving

    AML

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    Patients aged 16 to 60 years are eligible. patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for aml. they could have received transfusion, hematopoietic growth factors or vitamins. temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed.
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    the relative expression level of mdr1 mrna (mdr1/gapdh ratio using the quantitative real-time pcr) in pre-treated bone marrow samples should over 0.016 (cut-off point from our results of preliminary experiment data)
    Beschrijving

    ABCB1 gene

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0376622
    ECOG performance status of 0, 1, 2 at screening
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl -
    Beschrijving

    Creatinine

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0010294
    Total bilirubin </= 2.0 mg/dl, unless increase is due to hemolysis -
    Beschrijving

    Bilirubin

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0005437
    Transaminases (sg pt) </= 3x uln
    Beschrijving

    Transaminases

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0002594
    Ability to understand and provide signed informed consent.
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    Subjects with acute promyelocytic leukemia (apl)
    Beschrijving

    Acute Promyelocytic Leukemia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023487
    Presence of active systemic infection
    Beschrijving

    Systemic infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0243026
    Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
    Beschrijving

    Medical condition

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0009488
    Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, iud, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
    Beschrijving

    Positive urine pregnancy test

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0430059

    Similar models

    Eligibility Acute Myeloid Leukemia NCT01889407

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML
    Item
    Diagnosis of aml (who classification definition of >/= 20% blasts).
    boolean
    C0023467 (UMLS CUI [1])
    Age
    Item
    Patients aged 16 to 60 years are eligible. patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for aml. they could have received transfusion, hematopoietic growth factors or vitamins. temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed.
    boolean
    C0001779 (UMLS CUI [1])
    ABCB1 gene
    Item
    the relative expression level of mdr1 mrna (mdr1/gapdh ratio using the quantitative real-time pcr) in pre-treated bone marrow samples should over 0.016 (cut-off point from our results of preliminary experiment data)
    boolean
    C0376622 (UMLS CUI [1])
    ECOG performance status
    Item
    ECOG performance status of 0, 1, 2 at screening
    boolean
    C1520224 (UMLS CUI [1])
    Creatinine
    Item
    Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl -
    boolean
    C0010294 (UMLS CUI [1])
    Bilirubin
    Item
    Total bilirubin </= 2.0 mg/dl, unless increase is due to hemolysis -
    boolean
    C0005437 (UMLS CUI [1])
    Transaminases
    Item
    Transaminases (sg pt) </= 3x uln
    boolean
    C0002594 (UMLS CUI [1])
    Informed Consent
    Item
    Ability to understand and provide signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Acute Promyelocytic Leukemia
    Item
    Subjects with acute promyelocytic leukemia (apl)
    boolean
    C0023487 (UMLS CUI [1])
    Systemic infection
    Item
    Presence of active systemic infection
    boolean
    C0243026 (UMLS CUI [1])
    Medical condition
    Item
    Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
    boolean
    C0525058 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    Positive urine pregnancy test
    Item
    Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, iud, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
    boolean
    C0430059 (UMLS CUI [1])

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