Information:
Fel:
ID
14037
Beskrivning
Efficacy and Safety of G-CSF in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid; ODM derived from: https://clinicaltrials.gov/show/NCT02442180
Länk
https://clinicaltrials.gov/show/NCT02442180
Nyckelord
Versioner (1)
- 2016-03-22 2016-03-22 -
Uppladdad den
22 mars 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Alcoholic Hepatitis NCT02442180
Eligibility Alcoholic Hepatitis NCT02442180
- StudyEvent: Eligibility
Similar models
Eligibility Alcoholic Hepatitis NCT02442180
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])