0 Ratings
ID

18132

Description

MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00606866

Link

https://clinicaltrials.gov/show/NCT00606866

Keywords

Versions (1)
  1. 10/21/16 10/21/16 -
Uploaded on

October 21, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
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 Metastatic Renal Cell Carcinoma NCT00606866

    English

    Eligibility Metastatic Renal Cell Carcinoma NCT00606866

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    histologically or cytologically confirmed metastatic clear cell renal cell cancer;
    Description

    Clear Cell Renal Cell Carcinoma Metastatic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0279702 (Conventional (Clear Cell) Renal Cell Carcinoma)
    SNOMED
    254915003
    UMLS CUI [1,2]
    C0036525 (Metastatic to)
    SNOMED
    77879006
    at least one lesion that can be accurately measured in at least one dimension;
    Description

    Measurable Disease Linear Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041 (Measurable Disease)
    UMLS CUI [1,2]
    C0205132 (Linear)
    SNOMED
    50009006
    LOINC
    LA15815-6
    UMLS CUI [1,3]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    patients must not have been treated with prior anti-timor kinase inhibitors or vegf pathway inhibitors;
    Description

    Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1152564 (Kinase Inhibitors [MoA])
    UMLS CUI [1,2]
    C0521124 (Against)
    SNOMED
    65897001
    UMLS CUI [1,3]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2,1]
    C2984329 (VEGF Signaling Pathway)
    UMLS CUI [2,2]
    C0243077 (inhibitors)
    age 18 and older;
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    ecog performance status 0-2;
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
    Description

    Blood pressure finding Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1271104 (Blood pressure finding)
    SNOMED
    392570002
    LOINC
    LP29704-1
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    normal organ function: total bilirubin less than upper limit of normal, ast less than 2.5 x upper limit of normal, creatinine less than 2.8 mg/dl;
    Description

    organ function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0678852 (body system or organ function)
    UMLS CUI [2]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [3]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    UMLS CUI [4]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
    Description

    Childbearing Potential Contraceptive methods | Gender Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    ability to understand and the willingness to sign a written informed consent document.
    Description

    Informed Consent

    Data type

    boolean

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

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    chemotherapy or radiotherapy within 4 weeks prior to entering the study;
    Description

    Chemotherapy | Therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    any other investigational agents;
    Description

    Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    known brain metastases;
    Description

    Metastatic malignant neoplasm to brain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
    Description

    Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423 (Illness (finding))
    SNOMED
    39104002
    UMLS CUI [1,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [2]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [3]
    C0742758 (Symptomatic congestive heart failure)
    SNOMED
    698594003
    UMLS CUI [4]
    C0002965 (Angina, Unstable)
    SNOMED
    4557003
    UMLS CUI [5]
    C0003811 (Cardiac Arrhythmia)
    SNOMED
    698247007
    LOINC
    LA7414-1
    UMLS CUI [6,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [6,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [6,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [7,1]
    C0748872 (social situation)
    UMLS CUI [7,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [7,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    pregnancy.
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    Back to the top of the page

    Similar models

    Eligibility Metastatic Renal Cell Carcinoma NCT00606866

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Clear Cell Renal Cell Carcinoma Metastatic
    Item
    histologically or cytologically confirmed metastatic clear cell renal cell cancer;
    boolean
    C0279702 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    Measurable Disease Linear Quantity
    Item
    at least one lesion that can be accurately measured in at least one dimension;
    boolean
    C1513041 (UMLS CUI [1,1])
    C0205132 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors
    Item
    patients must not have been treated with prior anti-timor kinase inhibitors or vegf pathway inhibitors;
    boolean
    C1152564 (UMLS CUI [1,1])
    C0521124 (UMLS CUI [1,2])
    C0006826 (UMLS CUI [1,3])
    C2984329 (UMLS CUI [2,1])
    C0243077 (UMLS CUI [2,2])
    Age
    Item
    age 18 and older;
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status 0-2;
    boolean
    C1520224 (UMLS CUI [1])
    Blood pressure finding Quantity
    Item
    blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
    boolean
    C1271104 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    organ function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
    Item
    normal organ function: total bilirubin less than upper limit of normal, ast less than 2.5 x upper limit of normal, creatinine less than 2.8 mg/dl;
    boolean
    C0678852 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C0201976 (UMLS CUI [4])
    Childbearing Potential Contraceptive methods | Gender Contraceptive methods
    Item
    women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    Informed Consent
    Item
    ability to understand and the willingness to sign a written informed consent document.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Chemotherapy | Therapeutic radiology procedure
    Item
    chemotherapy or radiotherapy within 4 weeks prior to entering the study;
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    Investigational New Drugs
    Item
    any other investigational agents;
    boolean
    C0013230 (UMLS CUI [1])
    Metastatic malignant neoplasm to brain
    Item
    known brain metastases;
    boolean
    C0220650 (UMLS CUI [1])
    Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
    Item
    uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0009450 (UMLS CUI [2])
    C0742758 (UMLS CUI [3])
    C0002965 (UMLS CUI [4])
    C0003811 (UMLS CUI [5])
    C0004936 (UMLS CUI [6,1])
    C1321605 (UMLS CUI [6,2])
    C0439801 (UMLS CUI [6,3])
    C0748872 (UMLS CUI [7,1])
    C1321605 (UMLS CUI [7,2])
    C0439801 (UMLS CUI [7,3])
    Pregnancy
    Item
    pregnancy.
    boolean
    C0032961 (UMLS CUI [1])
    Back to the top of the page 

    Contact

    Please use this form for feedback, questions and suggestions for improvements.

    Fields marked with * are required.

    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