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ID

15393

Description

Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02150317

Link

https://clinicaltrials.gov/show/NCT02150317

Keywords

Versions (1)
  1. 5/29/16 5/29/16 -
Uploaded on

May 29, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Advanced Hepatocellular Carcinoma NCT02150317

    English

    Eligibility Advanced Hepatocellular Carcinoma NCT02150317

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    male or female patients > 18 years and <=70 years of age.
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence.
    Description

    hepatocellular carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2239176 (Liver carcinoma)
    SNOMED
    109841003
    tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis.
    Description

    vascular invasion or extrahepatic metastasis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521157 (Tumor Vascular Invasion)
    UMLS CUI [2]
    C0474915 (TNM Extrahepatic bile ducts tumor staging)
    SNOMED
    254314006
    criteria of liver function: child a-b level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
    Description

    child a-b level, serum bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4050412 (Child-Pugh Clinical Classification)
    SNOMED
    3191000175106
    UMLS CUI [2]
    C0428441 (Serum bilirubin measurement)
    SNOMED
    166610007
    no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal.
    Description

    major organs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0026766 (Multiple Organ Failure)
    SNOMED
    57653000
    hb ≥90g/l,white blood cell count ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
    Description

    white blood cell count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508 (White Blood Cell Count procedure)
    SNOMED
    767002
    patients who can understand this trial and have signed informed consent
    Description

    informed consent

    Data type

    boolean

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

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of liver cancer.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058 (Protocol Compliance)
    UMLS CUI [2]
    C0009488 (Comorbidity)
    patients with a medical history of other malignant tumors
    Description

    Malignant Neoplasms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    subjects participating in other clinical trials
    Description

    subjects participating in other clinical trials

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    liver function:child c
    Description

    Child-Pugh Class C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3831115 (Child-Pugh Class C)
    no pathological evidence of hepatocellular carcinoma.
    Description

    no pathological evidence of hepatocellular carcinoma.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0205469 (Pathological aspects)
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    Similar models

    Eligibility Advanced Hepatocellular Carcinoma NCT02150317

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    male or female patients > 18 years and <=70 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    hepatocellular carcinoma
    Item
    at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence.
    boolean
    C2239176 (UMLS CUI [1])
    vascular invasion or extrahepatic metastasis
    Item
    tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis.
    boolean
    C0521157 (UMLS CUI [1])
    C0474915 (UMLS CUI [2])
    child a-b level, serum bilirubin
    Item
    criteria of liver function: child a-b level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
    boolean
    C4050412 (UMLS CUI [1])
    C0428441 (UMLS CUI [2])
    major organs
    Item
    no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal.
    boolean
    C0026766 (UMLS CUI [1])
    white blood cell count
    Item
    hb ≥90g/l,white blood cell count ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
    boolean
    C0023508 (UMLS CUI [1])
    informed consent
    Item
    patients who can understand this trial and have signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status
    Item
    patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of liver cancer.
    boolean
    C0525058 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    Malignant Neoplasms
    Item
    patients with a medical history of other malignant tumors
    boolean
    C0006826 (UMLS CUI [1])
    subjects participating in other clinical trials
    Item
    subjects participating in other clinical trials
    boolean
    C2348568 (UMLS CUI [1])
    Child-Pugh Class C
    Item
    liver function:child c
    boolean
    C3831115 (UMLS CUI [1])
    no pathological evidence of hepatocellular carcinoma.
    Item
    no pathological evidence of hepatocellular carcinoma.
    boolean
    C0205469 (UMLS CUI [1])
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