0 Evaluaciones
ID

18132

Descripción

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

Palabras clave

Versiones (1)
  1. 21/10/16 21/10/16 -
Subido en

21 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Metastatic Renal Cell Carcinoma NCT00606866

    Inglés

    Eligibility Metastatic Renal Cell Carcinoma NCT00606866

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

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

    Clear Cell Renal Cell Carcinoma Metastatic

    Tipo de datos

    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;
    Descripción

    Measurable Disease Linear Quantity

    Tipo de datos

    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;
    Descripción

    Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors

    Tipo de datos

    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;
    Descripción

    Age

    Tipo de datos

    boolean

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

    ECOG performance status

    Tipo de datos

    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;
    Descripción

    Blood pressure finding Quantity

    Tipo de datos

    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;
    Descripción

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

    Tipo de datos

    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;
    Descripción

    Childbearing Potential Contraceptive methods | Gender Contraceptive methods

    Tipo de datos

    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.
    Descripción

    Informed Consent

    Tipo de datos

    boolean

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

    Exclusion Criteria

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

    Chemotherapy | Therapeutic radiology procedure

    Tipo de datos

    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;
    Descripción

    Investigational New Drugs

    Tipo de datos

    boolean

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

    Metastatic malignant neoplasm to brain

    Tipo de datos

    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;
    Descripción

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

    Tipo de datos

    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.
    Descripción

    Pregnancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
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    Similar models

    Eligibility Metastatic Renal Cell Carcinoma NCT00606866

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

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