0 Ratings
ID

13160

Description

Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00104468

Link

https://clinicaltrials.gov/show/NCT00104468

Keywords

Versions (1)
  1. 1/20/16 1/20/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 20, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Eligibility Acute Myelogenous Leukemia NCT00104468

    English

    Eligibility Acute Myelogenous Leukemia NCT00104468

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    confirmed diagnosis of acute myelogenous leukemia (aml) refractory to prior therapy and/or unlikely to benefit from known therapies.
    Description

    AML

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    subjects must have adequate organ and immune function as indicated by the following laboratory values: *creatinine clearance ≥5 l/hr (83ml/min), *total bilirubin ≤2.0 mg/dl (≤34.2 µmol/l), *ast(sgot) and alt(sgpt) ≤3 x uln
    Description

    organ and immune function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    UMLS CUI [2]
    C1278039
    UMLS CUI [3]
    C0201899
    UMLS CUI [4]
    C0201836
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    clinical evidence of active central nervous system (cns) leukemic involvement
    Description

    cns leukemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1332884
    active and uncontrolled infection
    Description

    infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment
    Description

    uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
    Description

    neurologic or psychiatric disorders that would interfere with informed consent or study follow-up

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.
    Description

    known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0877874
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0209738
    UMLS CUI [3]
    C0038586
    also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.
    Description

    subjects who have used another investigational agent or participated in a clinical trial

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.
    Description

    pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    Back to the top of the page

    Similar models

    Eligibility Acute Myelogenous Leukemia NCT00104468

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML
    Item
    confirmed diagnosis of acute myelogenous leukemia (aml) refractory to prior therapy and/or unlikely to benefit from known therapies.
    boolean
    C0023467 (UMLS CUI [1])
    organ and immune function
    Item
    subjects must have adequate organ and immune function as indicated by the following laboratory values: *creatinine clearance ≥5 l/hr (83ml/min), *total bilirubin ≤2.0 mg/dl (≤34.2 µmol/l), *ast(sgot) and alt(sgpt) ≤3 x uln
    boolean
    C0373595 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C0201836 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    cns leukemia
    Item
    clinical evidence of active central nervous system (cns) leukemic involvement
    boolean
    C1332884 (UMLS CUI [1])
    infection
    Item
    active and uncontrolled infection
    boolean
    C0009450 (UMLS CUI [1])
    uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment
    Item
    uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment
    boolean
    C0021430 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
    Item
    neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
    boolean
    C0021430 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse
    Item
    known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0877874 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0209738 (UMLS CUI [2,2])
    C0038586 (UMLS CUI [3])
    subjects who have used another investigational agent or participated in a clinical trial
    Item
    also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.
    boolean
    C2348568 (UMLS CUI [1])
    pregnancy
    Item
    females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.
    boolean
    C0032961 (UMLS CUI [1])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial