ID

14078

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02075918

Nyckelord

  1. 2016-03-27 2016-03-27 -
Uppladdad den

27 mars 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Alcoholic Hepatitis NCT02075918

Eligibility Alcoholic Hepatitis NCT02075918

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

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).
Beskrivning

Alcohol abuse

Datatyp

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.
Beskrivning

Transaminases

Datatyp

boolean

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

GGT

Datatyp

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).
Beskrivning

autoimmune liver disease

Datatyp

boolean

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

Hepatitis B and hepatitis C

Datatyp

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).
Beskrivning

Decompensated cirrhosis

Datatyp

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:
Beskrivning

histological confirmation

Datatyp

integer

Alias
UMLS CUI [1]
C0449575
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatocellular carcinoma.
Beskrivning

hepatocellular carcinoma

Datatyp

boolean

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

undefined item

Datatyp

boolean

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

extrahepatic diseases

Datatyp

boolean

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

consent

Datatyp

boolean

Alias
UMLS CUI [1]
C1511481
pregnancy
Beskrivning

pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Alcoholic Hepatitis NCT02075918

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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