ID

43059

Description

Intensive Enteral Nutrition and Acute Alcoholic Hepatitis; ODM derived from: https://clinicaltrials.gov/show/NCT01801332

Link

https://clinicaltrials.gov/show/NCT01801332

Keywords

Versions (1)
  1. 9/18/21 9/18/21 -
Copyright Holder

Erasme University Hospital

Uploaded on

September 18, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Severe Alcoholic Hepatitis NCT01801332

English

Eligibility Severe Alcoholic Hepatitis NCT01801332

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
acute alcoholic hepatitis proven by a liver biopsy (necessary histological findings : neutrophils infiltration, ballooned hepatocytes and mallory bodies)
Description

Acute alcoholic hepatitis proven by a liver biopsy | Histological findings : neutrophils infiltration, ballooned hepatocytes and mallory bodies

Data type

boolean

Alias
UMLS CUI [1,1]
C0019187
UMLS CUI [1,2]
C0193388
UMLS CUI [1,3]
C0001314
UMLS CUI [2,1]
C0333744
UMLS CUI [2,2]
C0027950
UMLS CUI [2,3]
C0332448
UMLS CUI [2,4]
C0333445
UMLS CUI [2,5]
C0227525
UMLS CUI [2,6]
C0449575
presence of a severe disease, defined by a maddrey score higher than or equal to 32, at screening and in baseline (day 0). maddrey score = total bilirubin in mg/dl + 4,6 x (prothrombin time patient in sec - prothrombin time control in sec)
Description

Discriminat analysis (Total bilirubin measurement, Prothrombin time assay)

Data type

boolean

Alias
UMLS CUI [1,1]
C0012630
UMLS CUI [1,2]
C0201913
UMLS CUI [1,3]
C0033707
age between 18 and 75 years old, extremes included
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
recent jaundice or in recent aggravation (less than 3 months)
Description

Recent jaundice | Recent aggravation

Data type

boolean

Alias
UMLS CUI [1,1]
C0022346
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0541889
UMLS CUI [2,2]
C0332185
chronic alcohol consumption (more than 40 g/day)
Description

Chronic alcohol consumption, quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C1265611
informed consent read, understand and signed by the patient (in case of significant encephalopathy, a family representative can signed in place of the patient)
Description

Informed consent | In case of significant encephalopathy can be an informed consent signed by a family representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0019151
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0021430
UMLS CUI [2,4]
C0030701
maximal delay between admission and randomization of 14 days.
Description

Maximal delay between admission and randomization

Data type

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C1948053
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
other disease compromising 6 months survival of the patient
Description

Other disease compromising survival of the patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0023671
positive hiv or hcv serology, positive hbs antigen
Description

HIV seropositivity | HCV seropositivity | HBs antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0850489
UMLS CUI [2,2]
C1446409
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C1446409
uncontrolled bacterial or fungal infection (infection must be judged controlled for at least 3 days)
Description

Uncontrolled bacterial infection | Uncontrolled mycosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0026946
UMLS CUI [2,2]
C0205318
uncontrolled upper gi bleeding (bleeding must be controlled for at least 5 days)
Description

Uncontrolled upper GI bleeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0041909
UMLS CUI [1,2]
C0205318
type 1 hepatorenal syndrome (creatinin upper than 2,5 mg/dl), as defined by salerno f et al, gut 2007;56:1310-1318
Description

Type 1 Hepatorenal syndrome, creatinine measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0019212
UMLS CUI [1,2]
C0201976
UMLS CUI [1,3]
C0332307
history of bariatric surgery
Description

History of bariatric surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1456587
UMLS CUI [1,2]
C0262926
pentoxyphilline therapy
Description

Pentoxifylline therapy

Data type

boolean

Alias
UMLS CUI [1]
C0030899
mars therapy
Description

Molecular Adsorbent Recirculating System

Data type

boolean

Alias
UMLS CUI [1,1]
C0567416
UMLS CUI [1,2]
C0087111
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Similar models

Eligibility Severe Alcoholic Hepatitis NCT01801332

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute alcoholic hepatitis proven by a liver biopsy | Histological findings : neutrophils infiltration, ballooned hepatocytes and mallory bodies
Item
acute alcoholic hepatitis proven by a liver biopsy (necessary histological findings : neutrophils infiltration, ballooned hepatocytes and mallory bodies)
boolean
C0019187 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0001314 (UMLS CUI [1,3])
C0333744 (UMLS CUI [2,1])
C0027950 (UMLS CUI [2,2])
C0332448 (UMLS CUI [2,3])
C0333445 (UMLS CUI [2,4])
C0227525 (UMLS CUI [2,5])
C0449575 (UMLS CUI [2,6])
Discriminat analysis (Total bilirubin measurement, Prothrombin time assay)
Item
presence of a severe disease, defined by a maddrey score higher than or equal to 32, at screening and in baseline (day 0). maddrey score = total bilirubin in mg/dl + 4,6 x (prothrombin time patient in sec - prothrombin time control in sec)
boolean
C0012630 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C0033707 (UMLS CUI [1,3])
Age
Item
age between 18 and 75 years old, extremes included
boolean
C0001779 (UMLS CUI [1])
Recent jaundice | Recent aggravation
Item
recent jaundice or in recent aggravation (less than 3 months)
boolean
C0022346 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0541889 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Chronic alcohol consumption, quantity
Item
chronic alcohol consumption (more than 40 g/day)
boolean
C0001948 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Informed consent | In case of significant encephalopathy can be an informed consent signed by a family representative
Item
informed consent read, understand and signed by the patient (in case of significant encephalopathy, a family representative can signed in place of the patient)
boolean
C0021430 (UMLS CUI [1])
C0019151 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0030701 (UMLS CUI [2,4])
Maximal delay between admission and randomization
Item
maximal delay between admission and randomization of 14 days.
boolean
C0184666 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Other disease compromising survival of the patient
Item
other disease compromising 6 months survival of the patient
boolean
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0023671 (UMLS CUI [1,4])
HIV seropositivity | HCV seropositivity | HBs antigen positive
Item
positive hiv or hcv serology, positive hbs antigen
boolean
C0019699 (UMLS CUI [1])
C0850489 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
Uncontrolled bacterial infection | Uncontrolled mycosis
Item
uncontrolled bacterial or fungal infection (infection must be judged controlled for at least 3 days)
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0026946 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Uncontrolled upper GI bleeding
Item
uncontrolled upper gi bleeding (bleeding must be controlled for at least 5 days)
boolean
C0041909 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Type 1 Hepatorenal syndrome, creatinine measurement
Item
type 1 hepatorenal syndrome (creatinin upper than 2,5 mg/dl), as defined by salerno f et al, gut 2007;56:1310-1318
boolean
C0019212 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
History of bariatric surgery
Item
history of bariatric surgery
boolean
C1456587 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Pentoxifylline therapy
Item
pentoxyphilline therapy
boolean
C0030899 (UMLS CUI [1])
Molecular Adsorbent Recirculating System
Item
mars therapy
boolean
C0567416 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
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