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ID

42118

Beschreibung

Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01405573

Link

https://clinicaltrials.gov/show/NCT01405573

Stichworte

  1. 27.05.16 27.05.16 -
  2. 10.04.21 10.04.21 - Ahmed Rafee, MD
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folgt

Hochgeladen am

10. April 2021

DOI

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Creative Commons BY 4.0

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    Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573

    Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients with diagnosis of hepatic cell carcinoma (hcc) according to the aasld- easl criteria
    Beschreibung

    hepatic cell carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2239176 (Liver carcinoma)
    SNOMED
    109841003
    age >18 years
    Beschreibung

    age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    advanced stage of disease defined as hcc not eligible for locoregional treatments (ab initio or following progression after such treatments)
    Beschreibung

    locoregional hcc

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0027643 (Neoplasm Recurrence, Local)
    liver function classified as child-pugh class b
    Beschreibung

    child-pugh class b

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3831116 (Child-Pugh Class B)
    ecog performance status < or = 2
    Beschreibung

    ecog

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    life expectancy of at least 2 months
    Beschreibung

    life expectancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    adequate contraception for fertile male and female patients
    Beschreibung

    contraception

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0420837 (Contraception status)
    SNOMED
    243816001
    signed informed consent
    Beschreibung

    informed consent

    Datentyp

    boolean

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

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    prior exposure to sorafenib or antiangiogenesis drugs
    Beschreibung

    sorafenib

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1516119 (sorafenib)
    SNOMED
    422042001
    UMLS CUI [2]
    C0596087 (Angiogenesis Inhibitors)
    SNOMED
    409408008
    concomitant diseases that contraindicate the use of sorafenib
    Beschreibung

    concomitant diseases

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0150941 (Concomitant or past diseases)
    gastro-intestinal bleeding in the previous 30 days
    Beschreibung

    gastro-intestinal bleeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0017181 (Gastrointestinal Hemorrhage)
    SNOMED
    74474003
    LOINC
    LP209002-7
    altered renal function(creatinine > 1.5 x uln), or haematological function (platelet count < 60 x 10^9/l, hemoglobin < 9 g/dl)
    Beschreibung

    renal function, hemoglobin

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0518015 (Hemoglobin measurement)
    UMLS CUI [2]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    serious active infections (> grade 2 ctcae version 3.0)
    Beschreibung

    active infections

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia
    Beschreibung

    congestive heart failure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    patients who are unable or unwilling to participate in the study
    Beschreibung

    patients who are unable or unwilling to participate in the study

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    pregnant or lactating females
    Beschreibung

    pregnant or lactating females

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    UMLS CUI [2]
    C2828358 (Lactating (finding))
    hepatic encephalopathy of any grade
    Beschreibung

    hepatic encephalopathy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019151 (Hepatic Encephalopathy)
    SNOMED
    449902003

    Ähnliche Modelle

    Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    hepatic cell carcinoma
    Item
    patients with diagnosis of hepatic cell carcinoma (hcc) according to the aasld- easl criteria
    boolean
    C2239176 (UMLS CUI [1])
    age
    Item
    age >18 years
    boolean
    C0001779 (UMLS CUI [1])
    locoregional hcc
    Item
    advanced stage of disease defined as hcc not eligible for locoregional treatments (ab initio or following progression after such treatments)
    boolean
    C0027643 (UMLS CUI [1])
    child-pugh class b
    Item
    liver function classified as child-pugh class b
    boolean
    C3831116 (UMLS CUI [1])
    ecog
    Item
    ecog performance status < or = 2
    boolean
    C1520224 (UMLS CUI [1])
    life expectancy
    Item
    life expectancy of at least 2 months
    boolean
    C0023671 (UMLS CUI [1])
    contraception
    Item
    adequate contraception for fertile male and female patients
    boolean
    C0420837 (UMLS CUI [1])
    informed consent
    Item
    signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    sorafenib
    Item
    prior exposure to sorafenib or antiangiogenesis drugs
    boolean
    C1516119 (UMLS CUI [1])
    C0596087 (UMLS CUI [2])
    concomitant diseases
    Item
    concomitant diseases that contraindicate the use of sorafenib
    boolean
    C0150941 (UMLS CUI [1])
    gastro-intestinal bleeding
    Item
    gastro-intestinal bleeding in the previous 30 days
    boolean
    C0017181 (UMLS CUI [1])
    renal function, hemoglobin
    Item
    altered renal function(creatinine > 1.5 x uln), or haematological function (platelet count < 60 x 10^9/l, hemoglobin < 9 g/dl)
    boolean
    C0518015 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    active infections
    Item
    serious active infections (> grade 2 ctcae version 3.0)
    boolean
    C0009450 (UMLS CUI [1])
    congestive heart failure
    Item
    congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia
    boolean
    C0018802 (UMLS CUI [1])
    patients who are unable or unwilling to participate in the study
    Item
    patients who are unable or unwilling to participate in the study
    boolean
    C2348568 (UMLS CUI [1])
    pregnant or lactating females
    Item
    pregnant or lactating females
    boolean
    C0549206 (UMLS CUI [1])
    C2828358 (UMLS CUI [2])
    hepatic encephalopathy
    Item
    hepatic encephalopathy of any grade
    boolean
    C0019151 (UMLS CUI [1])

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