0 Avaliações
ID

43691

Descrição

Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00149565

Link

https://clinicaltrials.gov/show/NCT00149565

Palavras-chave

Versões (2)
  1. 24/02/2016 24/02/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Hepatocellular Carcinoma NCT00149565

    Inglês

    Eligibility Hepatocellular Carcinoma NCT00149565

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693 (Inclusion)
    1. histologically proven hepatocellular carcinoma.
    Descrição

    hepatocellular carcinoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2239176 (Liver carcinoma)
    SNOMED
    109841003
    2. hcc underwent curative resection within 6 weeks before registration.
    Descrição

    surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    3. grossly, the resection margin should be > 1 cm.
    Descrição

    resection margin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0229985 (Surgical margins)
    SNOMED
    871811002
    4. patients must be younger than 70 year-old.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    5. patients must have a performance status of ecog score < 2.
    Descrição

    ecog

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    6. patients must have adequate liver reservation and adequate hemogram.
    Descrição

    liver function and hemogram

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [2]
    C0200631 (Complete blood count without differential)
    SNOMED
    43789009
    LOINC
    LP21228-9
    7. pugh-child‘s score < 7.
    Descrição

    pugh-child score

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C4050412 (Child-Pugh Clinical Classification)
    SNOMED
    3191000175106
    8. the serum total bilirubin level are < 2 mg/dl.
    Descrição

    bilirubin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    9. the prothrombin times are < 3 sec above normal control.
    Descrição

    prothrombin time

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0033707 (Prothrombin time assay)
    SNOMED
    396451008
    10. the platelet are > 10 x 104 / mm3.
    Descrição

    platelets

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005821 (Blood Platelets)
    SNOMED
    16378004
    LOINC
    LP70360-0
    11. the wbc are > 3,000 / mm3.
    Descrição

    wbc

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023508 (White Blood Cell Count procedure)
    SNOMED
    767002
    12. patient must have serum creatinine < 1.5 mg/dl
    Descrição

    creatinine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    13. cardiac function with nyha classification < grade ii
    Descrição

    nyha

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1275491 (New York Heart Association Classification)
    SNOMED
    420816009
    LOINC
    LP264302-3
    14. known hbv or hcv status.
    Descrição

    hbv or hcv

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019163 (Hepatitis B)
    SNOMED
    66071002
    LOINC
    LA18126-5
    UMLS CUI [2]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    15. signed informed consent.
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    exclusion criteria:
    Descrição

    ID.16

    Tipo de dados

    boolean

    1. patients who have non-curative resection are not eligible.
    Descrição

    surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    2. resected hccs with histologically positive margins are not eligible.
    Descrição

    resection margins

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0229985 (Surgical margins)
    SNOMED
    871811002
    3. hccs with radiological evidence of portal vein thrombus are not eligible.
    Descrição

    portal vein thrombus

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2239176 (Liver carcinoma)
    SNOMED
    109841003
    UMLS CUI [2,1]
    C0087086 (Thrombus)
    SNOMED
    396339007
    LOINC
    MTHU052847
    UMLS CUI [2,2]
    C0032718 (Portal vein structure)
    SNOMED
    32764006
    4. patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
    Descrição

    steroids or immunosuppressant agents

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038317 (Steroids)
    SNOMED
    768759001
    LOINC
    LP20784-2
    UMLS CUI [2]
    C0021081 (Immunosuppressive Agents)
    SNOMED
    69431002
    5. patients with advanced second primary malignancy are not eligible.
    Descrição

    malignancies

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    6. patients with pregnacy or breast-feeding are not eligible.
    Descrição

    pregnant or breast-feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    7. patients with severe cardiopulmonary diseases are not eligible.
    Descrição

    cardiopulmonary disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    8. patients with clinically significant psychiatric disorder are not eligible.
    Descrição

    psychiatric disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    9. patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
    Descrição

    chemotherapy, immuno-therapeutic drugs or steroids within 6 weeks

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3665472 (Chemotherapy)
    SNOMED
    367336001
    LOINC
    MTHU010425
    UMLS CUI [2]
    C0876248 (Immunotherapeutic agent)
    SNOMED
    373244000
    UMLS CUI [3]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
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    Similar models

    Eligibility Hepatocellular Carcinoma NCT00149565

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    hepatocellular carcinoma
    Item
    1. histologically proven hepatocellular carcinoma.
    boolean
    C2239176 (UMLS CUI [1])
    surgery
    Item
    2. hcc underwent curative resection within 6 weeks before registration.
    boolean
    C0543467 (UMLS CUI [1])
    resection margin
    Item
    3. grossly, the resection margin should be > 1 cm.
    boolean
    C0229985 (UMLS CUI [1])
    Age
    Item
    4. patients must be younger than 70 year-old.
    boolean
    C0001779 (UMLS CUI [1])
    ecog
    Item
    5. patients must have a performance status of ecog score < 2.
    boolean
    C1520224 (UMLS CUI [1])
    liver function and hemogram
    Item
    6. patients must have adequate liver reservation and adequate hemogram.
    boolean
    C0232741 (UMLS CUI [1])
    C0200631 (UMLS CUI [2])
    pugh-child score
    Item
    7. pugh-child‘s score < 7.
    boolean
    C4050412 (UMLS CUI [1])
    bilirubin
    Item
    8. the serum total bilirubin level are < 2 mg/dl.
    boolean
    C1278039 (UMLS CUI [1])
    prothrombin time
    Item
    9. the prothrombin times are < 3 sec above normal control.
    boolean
    C0033707 (UMLS CUI [1])
    platelets
    Item
    10. the platelet are > 10 x 104 / mm3.
    boolean
    C0005821 (UMLS CUI [1])
    wbc
    Item
    11. the wbc are > 3,000 / mm3.
    boolean
    C0023508 (UMLS CUI [1])
    creatinine
    Item
    12. patient must have serum creatinine < 1.5 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    nyha
    Item
    13. cardiac function with nyha classification < grade ii
    boolean
    C1275491 (UMLS CUI [1])
    hbv or hcv
    Item
    14. known hbv or hcv status.
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    informed consent
    Item
    15. signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    ID.16
    Item
    exclusion criteria:
    boolean
    surgery
    Item
    1. patients who have non-curative resection are not eligible.
    boolean
    C0543467 (UMLS CUI [1])
    resection margins
    Item
    2. resected hccs with histologically positive margins are not eligible.
    boolean
    C0229985 (UMLS CUI [1])
    portal vein thrombus
    Item
    3. hccs with radiological evidence of portal vein thrombus are not eligible.
    boolean
    C2239176 (UMLS CUI [1])
    C0087086 (UMLS CUI [2,1])
    C0032718 (UMLS CUI [2,2])
    steroids or immunosuppressant agents
    Item
    4. patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
    boolean
    C0038317 (UMLS CUI [1])
    C0021081 (UMLS CUI [2])
    malignancies
    Item
    5. patients with advanced second primary malignancy are not eligible.
    boolean
    C0006826 (UMLS CUI [1])
    pregnant or breast-feeding
    Item
    6. patients with pregnacy or breast-feeding are not eligible.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    cardiopulmonary disease
    Item
    7. patients with severe cardiopulmonary diseases are not eligible.
    boolean
    C0009488 (UMLS CUI [1])
    psychiatric disorder
    Item
    8. patients with clinically significant psychiatric disorder are not eligible.
    boolean
    C0004936 (UMLS CUI [1])
    chemotherapy, immuno-therapeutic drugs or steroids within 6 weeks
    Item
    9. patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
    boolean
    C3665472 (UMLS CUI [1])
    C0876248 (UMLS CUI [2])
    C0007222 (UMLS CUI [3])
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