0 Evaluaciones
ID

17554

Descripción

Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00142467

Link

https://clinicaltrials.gov/show/NCT00142467

Palabras clave

Versiones (1)
  1. 9/23/16 9/23/16 -
Subido en

September 23, 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Hepatocellular Carcinoma NCT00142467

    Inglés

    Eligibility Hepatocellular Carcinoma NCT00142467

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    unresectable or metastatic hepatocellular carcinoma
    Descripción

    Liver cell carcinoma non-resectable | Metastatic hepatocellular carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1112459 (Unresectable Hepatocellular Carcinoma)
    UMLS CUI [2]
    C0744869 (Metastatic hepatocellular carcinoma)
    SNOMED
    708973006
    measurable tumors
    Descripción

    Measurable Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    adequate hepatic function: total bilirubin < 3.0mg/dl; ast < 7x uln
    Descripción

    Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [2]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [3]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    adequate bone marrow function: anc > 1,000/mm3; platelets > 75,000/mm3
    Descripción

    Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953 (Bone Marrow)
    SNOMED
    279729006
    LOINC
    LP7410-6
    UMLS CUI [1,2]
    C0031843 (physiological aspects)
    UMLS CUI [2]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [3]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    inr < 1.5 for those who are not on anticoagulation
    Descripción

    INR | Anticoagulation Therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0525032 (International Normalized Ratio)
    SNOMED
    1951000175101
    LOINC
    LP20762-8
    UMLS CUI [2]
    C0003281 (Anticoagulation Therapy)
    up to two prior chemotherapy regimens for hepatocellular carcinoma
    Descripción

    Prior Chemotherapy Quantity Liver carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [1,3]
    C2239176 (Liver carcinoma)
    SNOMED
    109841003
    18 years of age or older
    Descripción

    Age

    Tipo de datos

    boolean

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

    ECOG performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    life expectancy of > 12 weeks
    Descripción

    Life Expectancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    clinically apparent central nervous system metastases or carcinomatous meningitis
    Descripción

    CNS metastases apparent Clinical | Meningeal Carcinomatosis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0686377 (CNS metastases)
    SNOMED
    94243009
    UMLS CUI [1,2]
    C0750489 (apparent)
    UMLS CUI [1,3]
    C0205210 (Clinical)
    SNOMED
    58147004
    UMLS CUI [2]
    C0220654 (Meningeal Carcinomatosis)
    SNOMED
    230156002
    uncontrolled serious medical or psychiatric illness
    Descripción

    Illness Serious Uncontrolled | Mental disorders

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423 (Illness (finding))
    SNOMED
    39104002
    UMLS CUI [1,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    UMLS CUI [1,3]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [2]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    pregnant or lactating women
    Descripción

    Pregnancy | Breast Feeding

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    current or recent (within 4 weeks of first study infusion) participation in experimental study drug
    Descripción

    Study Subject Participation Status | Investigational New Drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2]
    C0013230 (Investigational New Drugs)
    uncontrolled hypertension
    Descripción

    Uncontrolled hypertension

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1868885 (Uncontrolled hypertension)
    significant proteinuria
    Descripción

    Proteinuria Significant

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0033687 (Proteinuria)
    SNOMED
    29738008
    LOINC
    LA17011-0
    UMLS CUI [1,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    serious, non-healing wound, ulcer, or bone fracture
    Descripción

    Non-healed wound Serious | Ulcer | Fracture

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0750433 (Wound, non-healed)
    SNOMED
    125192008
    UMLS CUI [1,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    UMLS CUI [2]
    C0041582 (Ulcer)
    SNOMED
    429040005
    LOINC
    MTHU022920
    UMLS CUI [3]
    C0016658 (Fracture)
    SNOMED
    72704001
    LOINC
    LA7437-2
    evidence of bleeding diathesis or coagulopathy
    Descripción

    Bleeding tendency Evidence of | Blood Coagulation Disorders Evidence of

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1458140 (Bleeding tendency)
    SNOMED
    64779008
    LOINC
    LA20352-3
    UMLS CUI [1,2]
    C0332120 (Evidence of (contextual qualifier))
    SNOMED
    18669006
    UMLS CUI [2,1]
    C0005779 (Blood Coagulation Disorders)
    SNOMED
    64779008
    UMLS CUI [2,2]
    C0332120 (Evidence of (contextual qualifier))
    SNOMED
    18669006
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    Similar models

    Eligibility Hepatocellular Carcinoma NCT00142467

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Liver cell carcinoma non-resectable | Metastatic hepatocellular carcinoma
    Item
    unresectable or metastatic hepatocellular carcinoma
    boolean
    C1112459 (UMLS CUI [1])
    C0744869 (UMLS CUI [2])
    Measurable Disease
    Item
    measurable tumors
    boolean
    C1513041 (UMLS CUI [1])
    Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement
    Item
    adequate hepatic function: total bilirubin < 3.0mg/dl; ast < 7x uln
    boolean
    C0232741 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
    Item
    adequate bone marrow function: anc > 1,000/mm3; platelets > 75,000/mm3
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0948762 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    INR | Anticoagulation Therapy
    Item
    inr < 1.5 for those who are not on anticoagulation
    boolean
    C0525032 (UMLS CUI [1])
    C0003281 (UMLS CUI [2])
    Prior Chemotherapy Quantity Liver carcinoma
    Item
    up to two prior chemotherapy regimens for hepatocellular carcinoma
    boolean
    C1514457 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C2239176 (UMLS CUI [1,3])
    Age
    Item
    18 years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status of 0-1
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy of > 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    CNS metastases apparent Clinical | Meningeal Carcinomatosis
    Item
    clinically apparent central nervous system metastases or carcinomatous meningitis
    boolean
    C0686377 (UMLS CUI [1,1])
    C0750489 (UMLS CUI [1,2])
    C0205210 (UMLS CUI [1,3])
    C0220654 (UMLS CUI [2])
    Illness Serious Uncontrolled | Mental disorders
    Item
    uncontrolled serious medical or psychiatric illness
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0205318 (UMLS CUI [1,3])
    C0004936 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Study Subject Participation Status | Investigational New Drugs
    Item
    current or recent (within 4 weeks of first study infusion) participation in experimental study drug
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Uncontrolled hypertension
    Item
    uncontrolled hypertension
    boolean
    C1868885 (UMLS CUI [1])
    Proteinuria Significant
    Item
    significant proteinuria
    boolean
    C0033687 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Non-healed wound Serious | Ulcer | Fracture
    Item
    serious, non-healing wound, ulcer, or bone fracture
    boolean
    C0750433 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0041582 (UMLS CUI [2])
    C0016658 (UMLS CUI [3])
    Bleeding tendency Evidence of | Blood Coagulation Disorders Evidence of
    Item
    evidence of bleeding diathesis or coagulopathy
    boolean
    C1458140 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
    C0005779 (UMLS CUI [2,1])
    C0332120 (UMLS CUI [2,2])
    Volver a la parte superior de la página 

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