ID

14078

Description

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

Link

https://clinicaltrials.gov/show/NCT02075918

Keywords

  1. 3/27/16 3/27/16 -
Uploaded on

March 27, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Alcoholic Hepatitis NCT02075918

Eligibility Alcoholic Hepatitis NCT02075918

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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).
Description

Alcohol abuse

Data type

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.
Description

Transaminases

Data type

boolean

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

GGT

Data type

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).
Description

autoimmune liver disease

Data type

boolean

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

Hepatitis B and hepatitis C

Data type

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).
Description

Decompensated cirrhosis

Data type

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:
Description

histological confirmation

Data type

integer

Alias
UMLS CUI [1]
C0449575
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatocellular carcinoma.
Description

hepatocellular carcinoma

Data type

boolean

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

undefined item

Data type

boolean

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

extrahepatic diseases

Data type

boolean

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

consent

Data type

boolean

Alias
UMLS CUI [1]
C1511481
pregnancy
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Alcoholic Hepatitis NCT02075918

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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