Eligibility Alcoholic Hepatitis NCT02281929

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 18-75
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
recent onset of jaundice (<3 months)
Description

jaundice

Data type

boolean

Alias
UMLS CUI [1]
C0022346
biopsy proven alcoholic hepatitis (transjugular liver biopsy)
Description

alcoholic hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0019187
maddrey's discriminant function ≥ 32, defining severe alcoholic hepatitis
Description

maddreys discriminant function

Data type

boolean

Alias
UMLS CUI [1]
C0012630
meld score ≥21
Description

Meld

Data type

boolean

Alias
UMLS CUI [1]
C1718072
alcohol consumption ≥ 40g/day (women) and ≥ 50g/day (men)
Description

alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous severe allergy or hypersensitivity to amoxicillin or clavulanic acid (anaphylactic shock, quincke edema, severe urticaria)
Description

hypersensitivity to amoxicillin or clavulanic acid

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002645
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0055860
hypersensitivity to any component of the medication
Description

hypersensitivity to medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
history of liver injury
Description

liver injury

Data type

boolean

Alias
UMLS CUI [1]
C0160390
phenylketonuria, because of the presence of aspartame in the powder for the oral suspension
Description

Phenylketonurias

Data type

boolean

Alias
UMLS CUI [1]
C0031485
type 1 hepatorenal syndrome before the initiation of treatment
Description

Hepatorenal Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0019212
severe extrahepatic disease
Description

Liver diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
any malignant tumor < 2 years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
uncontrolled gastrointestinal bleeding
Description

Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0017181
ongoing viral or parasitic infection
Description

Parasitic Diseases, Virus Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0030499
UMLS CUI [2]
C0042769
untreated bacterial infection.
Description

Bacterial Infections

Data type

boolean

Alias
UMLS CUI [1]
C0004623

Similar models

Eligibility Alcoholic Hepatitis NCT02281929

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients aged 18-75
boolean
C0001779 (UMLS CUI [1])
jaundice
Item
recent onset of jaundice (<3 months)
boolean
C0022346 (UMLS CUI [1])
alcoholic hepatitis
Item
biopsy proven alcoholic hepatitis (transjugular liver biopsy)
boolean
C0019187 (UMLS CUI [1])
maddreys discriminant function
Item
maddrey's discriminant function ≥ 32, defining severe alcoholic hepatitis
boolean
C0012630 (UMLS CUI [1])
Meld
Item
meld score ≥21
boolean
C1718072 (UMLS CUI [1])
alcohol consumption
Item
alcohol consumption ≥ 40g/day (women) and ≥ 50g/day (men)
boolean
C0001948 (UMLS CUI [1])
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypersensitivity to amoxicillin or clavulanic acid
Item
previous severe allergy or hypersensitivity to amoxicillin or clavulanic acid (anaphylactic shock, quincke edema, severe urticaria)
boolean
C0020517 (UMLS CUI [1,1])
C0002645 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0055860 (UMLS CUI [2,2])
hypersensitivity to medication
Item
hypersensitivity to any component of the medication
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
liver injury
Item
history of liver injury
boolean
C0160390 (UMLS CUI [1])
Phenylketonurias
Item
phenylketonuria, because of the presence of aspartame in the powder for the oral suspension
boolean
C0031485 (UMLS CUI [1])
Hepatorenal Syndrome
Item
type 1 hepatorenal syndrome before the initiation of treatment
boolean
C0019212 (UMLS CUI [1])
Liver diseases
Item
severe extrahepatic disease
boolean
C0023895 (UMLS CUI [1])
Malignant Neoplasms
Item
any malignant tumor < 2 years
boolean
C0006826 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
uncontrolled gastrointestinal bleeding
boolean
C0017181 (UMLS CUI [1])
Parasitic Diseases, Virus Diseases
Item
ongoing viral or parasitic infection
boolean
C0030499 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
Bacterial Infections
Item
untreated bacterial infection.
boolean
C0004623 (UMLS CUI [1])