ID

14078

Descripción

Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis; ODM derived from: https://clinicaltrials.gov/show/NCT02075918

Link

https://clinicaltrials.gov/show/NCT02075918

Palabras clave

  1. 27/3/16 27/3/16 -
Subido en

27 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Alcoholic Hepatitis NCT02075918

    Eligibility Alcoholic Hepatitis NCT02075918

    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients ≥18 and <70 years of age.
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    active alcohol abuse defined according to the diagnostic and statistical manual of mental disorders iv (dsm iv) and excessive alcohol consumption prior to admission (> 60 g per day for men and> 40 g per day for women).
    Descripción

    Alcohol abuse

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0085762
    moderate elevation of aminotransferases (usually less than 300 u / l) with a characteristic pattern of ast/ alt ratio of 2:1.
    Descripción

    Transaminases

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0002594
    elevated serum ggt and bilirubin levels.
    Descripción

    GGT

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0017040
    UMLS CUI [2]
    C0005437
    absence of prior autoimmune liver disease (ana<1/80, sma<1/80, lkm1 neg, ama neg).
    Descripción

    autoimmune liver disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0400936
    absence of hepatitis b and c and hiv infection (anti-hcv, surface hbv antigen and anti-hiv neg).
    Descripción

    Hepatitis B and hepatitis C

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2711110
    UMLS CUI [2]
    C0019693
    patients with decompensated alcoholic cirrhosis will be suitable for inclusion (eg, acute gastrointestinal bleeding, acute renal failure, hepatic encephalopathy and bacterial infections).
    Descripción

    Decompensated cirrhosis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1619727
    because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in all patients (preferably through a transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histologic features:
    Descripción

    histological confirmation

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0449575
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    hepatocellular carcinoma.
    Descripción

    hepatocellular carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2239176
    complete portal vein thrombosis.
    Descripción

    undefined item

    Tipo de datos

    boolean

    advanced or terminal extrahepatic diseases (eg heart failure, advanced lung diseases, advanced oncologic diseases).
    Descripción

    extrahepatic diseases

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1517058
    lack of consent to participate in the study.
    Descripción

    consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1511481
    pregnancy
    Descripción

    pregnancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961

    Similar models

    Eligibility Alcoholic Hepatitis NCT02075918

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    patients ≥18 and <70 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    Alcohol abuse
    Item
    active alcohol abuse defined according to the diagnostic and statistical manual of mental disorders iv (dsm iv) and excessive alcohol consumption prior to admission (> 60 g per day for men and> 40 g per day for women).
    boolean
    C0085762 (UMLS CUI [1])
    Transaminases
    Item
    moderate elevation of aminotransferases (usually less than 300 u / l) with a characteristic pattern of ast/ alt ratio of 2:1.
    boolean
    C0002594 (UMLS CUI [1])
    GGT
    Item
    elevated serum ggt and bilirubin levels.
    boolean
    C0017040 (UMLS CUI [1])
    C0005437 (UMLS CUI [2])
    autoimmune liver disease
    Item
    absence of prior autoimmune liver disease (ana<1/80, sma<1/80, lkm1 neg, ama neg).
    boolean
    C0400936 (UMLS CUI [1])
    Hepatitis B and hepatitis C
    Item
    absence of hepatitis b and c and hiv infection (anti-hcv, surface hbv antigen and anti-hiv neg).
    boolean
    C2711110 (UMLS CUI [1])
    C0019693 (UMLS CUI [2])
    Decompensated cirrhosis
    Item
    patients with decompensated alcoholic cirrhosis will be suitable for inclusion (eg, acute gastrointestinal bleeding, acute renal failure, hepatic encephalopathy and bacterial infections).
    boolean
    C1619727 (UMLS CUI [1])
    Item
    because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in all patients (preferably through a transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histologic features:
    integer
    C0449575 (UMLS CUI [1])
    Code List
    because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in all patients (preferably through a transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histologic features:
    CL Item
    steatosis (either macro or microvesicular). (1)
    C2711227 (UMLS CUI-1)
    CL Item
    hepatocellular damage (eg, hepatocyte ballooning and presence of mallory-denk bodies). (2)
    C0151763 (UMLS CUI-1)
    CL Item
    inflammatory infiltrate (predominantly polymorphonuclear cells). (3)
    C3887644 (UMLS CUI-1)
    CL Item
    pericellular or sinusoidal fibrosis. (4)
    C0016059 (UMLS CUI-1)
    Item Group
    C0680251 (UMLS CUI)
    hepatocellular carcinoma
    Item
    hepatocellular carcinoma.
    boolean
    C2239176 (UMLS CUI [1])
    undefined item
    Item
    complete portal vein thrombosis.
    boolean
    extrahepatic diseases
    Item
    advanced or terminal extrahepatic diseases (eg heart failure, advanced lung diseases, advanced oncologic diseases).
    boolean
    C1517058 (UMLS CUI [1])
    consent
    Item
    lack of consent to participate in the study.
    boolean
    C1511481 (UMLS CUI [1])
    pregnancy
    Item
    pregnancy
    boolean
    C0032961 (UMLS CUI [1])

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