Eligibility Alcoholic Hepatitis NCT02442180

Inclusion criteria
Description

Inclusion criteria

clinical significant alcohol intake history (men over 50g within 3 months, women over 40g within 3 months)
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
modified df score greater than or equal to 32
Description

discriminant function

Data type

boolean

Alias
UMLS CUI [1]
C0012630
transjugular liver biopsy shows typical feature of alcoholic hepatitis or meet the clinical diagnosis (total serum bilirubin level over 5 mg/dl, aspartate aminotransferase/alanine aminotransferase ratio >2, aspartate aminotransferase < 300 iu/l)
Description

transjugular liver biopsy

Data type

boolean

Alias
UMLS CUI [1]
C1955790
included patients should meet the all above criteria and lille score > 0.16 at the day 7 of prednisolone 40mg (or 32 mg of methylprednisolone) daily treatment.
Description

Lille score for alcoholic hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0032952
Exclusion criteria
Description

Exclusion criteria

hepatitis b surface antigen (hbsag), anti-hepatitis c virus (anti-hcv), or anti-human immunodeficiency virus (hiv) (+)
Description

hbsag, anti-hcv, hiv+

Data type

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
hepatocellular carcinoma
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
portal vein thrombosis, hemochromatosis, autoimmune hepatitis, wilson's disease, alpha-1-antitrypsin deficiency
Description

Portal vein thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0155773
pregnancy, breast feeding, or who refuses contraception, or who cannot do contraception
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of adverse event including allergic response, hypersensitivity to g-csf
Description

Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
hypovolemic shock due to gastrointestinal hemorrhage or who need packed red blood cell (rbc) transfusion more than 3 units or increased modified discriminant factor (df) score greater or equal to 32 from below 32 due to gastrointestinal hemorrhage
Description

Hypovolemic Shock

Data type

boolean

Alias
UMLS CUI [1]
C0020683
sepsis or uncontrolled acute infection
Description

sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0243026
hepatic encephalopathy grade 3-4
Description

Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0019151
history of steroid or pentoxifylline treatment within 3 months
Description

Pentoxifylline or Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0030899
UMLS CUI [2]
C0149783
myeloblast on peripheral blood smear test
Description

myeloblast

Data type

boolean

Alias
UMLS CUI [1]
C0229633
critical comorbidities (type i hepatorenal syndrome, serum creatinine >2.5mg/dl, heart failure, pulmonary disease, psychiatric disease, acute pancreatitis etc.)
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patient who refuses to participate in clinical trial
Description

patient who refuses to participate in clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C3242233

Similar models

Eligibility Alcoholic Hepatitis NCT02442180

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
Alcohol consumption
Item
clinical significant alcohol intake history (men over 50g within 3 months, women over 40g within 3 months)
boolean
C0001948 (UMLS CUI [1])
discriminant function
Item
modified df score greater than or equal to 32
boolean
C0012630 (UMLS CUI [1])
transjugular liver biopsy
Item
transjugular liver biopsy shows typical feature of alcoholic hepatitis or meet the clinical diagnosis (total serum bilirubin level over 5 mg/dl, aspartate aminotransferase/alanine aminotransferase ratio >2, aspartate aminotransferase < 300 iu/l)
boolean
C1955790 (UMLS CUI [1])
Lille score for alcoholic hepatitis
Item
included patients should meet the all above criteria and lille score > 0.16 at the day 7 of prednisolone 40mg (or 32 mg of methylprednisolone) daily treatment.
boolean
C0032952 (UMLS CUI [1])
Item Group
Exclusion criteria
hbsag, anti-hcv, hiv+
Item
hepatitis b surface antigen (hbsag), anti-hepatitis c virus (anti-hcv), or anti-human immunodeficiency virus (hiv) (+)
boolean
C0019168 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Liver carcinoma
Item
hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Portal vein thrombosis
Item
portal vein thrombosis, hemochromatosis, autoimmune hepatitis, wilson's disease, alpha-1-antitrypsin deficiency
boolean
C0155773 (UMLS CUI [1])
pregnancy, breast feeding
Item
pregnancy, breast feeding, or who refuses contraception, or who cannot do contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Adverse event
Item
history of adverse event including allergic response, hypersensitivity to g-csf
boolean
C0877248 (UMLS CUI [1])
Hypovolemic Shock
Item
hypovolemic shock due to gastrointestinal hemorrhage or who need packed red blood cell (rbc) transfusion more than 3 units or increased modified discriminant factor (df) score greater or equal to 32 from below 32 due to gastrointestinal hemorrhage
boolean
C0020683 (UMLS CUI [1])
sepsis
Item
sepsis or uncontrolled acute infection
boolean
C0243026 (UMLS CUI [1])
Hepatic Encephalopathy
Item
hepatic encephalopathy grade 3-4
boolean
C0019151 (UMLS CUI [1])
Pentoxifylline or Steroid therapy
Item
history of steroid or pentoxifylline treatment within 3 months
boolean
C0030899 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
myeloblast
Item
myeloblast on peripheral blood smear test
boolean
C0229633 (UMLS CUI [1])
Comorbidity
Item
critical comorbidities (type i hepatorenal syndrome, serum creatinine >2.5mg/dl, heart failure, pulmonary disease, psychiatric disease, acute pancreatitis etc.)
boolean
C0009488 (UMLS CUI [1])
patient who refuses to participate in clinical trial
Item
patient who refuses to participate in clinical trial
boolean
C3242233 (UMLS CUI [1])