Informationen:
Fehler:
ID
14081
Beschreibung
Study of IDN-6556 in Patients With Severe AH and Contradictions to Steroid Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01912404
Link
https://clinicaltrials.gov/show/NCT01912404
Stichworte
Versionen (1)
- 28.03.16 28.03.16 -
Hochgeladen am
28. März 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Alcoholic Hepatitis NCT01912404
Eligibility Alcoholic Hepatitis NCT01912404
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Alcoholic Hepatitis NCT01912404
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age
Item
male or female patients 21 years of age or older
boolean
C0001779 (UMLS CUI [1])
alcoholic hepatitis
Item
patients with alcoholic hepatitis defined as:
boolean
C0019187 (UMLS CUI [1])
heavy alcohol abuse
Item
history of heavy alcohol abuse use: >40 g/day in females and >60 g/day in males for a minimum period of 6 months
boolean
C0740861 (UMLS CUI [1])
alcohol consumed
Item
consumed alcohol within 6 weeks of entry into the study
boolean
C3700016 (UMLS CUI [1])
severe disease
Item
biochemical parameters of severe disease as evidenced by meld score >20 but <35, or meld score 35-40 if the sofa score is <10
boolean
C1718072 (UMLS CUI [1])
C3494459 (UMLS CUI [2])
C3494459 (UMLS CUI [2])
Steroids
Item
patients with established contraindications to steroid use including but not limited to the following:
boolean
C0038317 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
gi bleed
boolean
C0017181 (UMLS CUI [1])
infection
Item
active infection, including spontaneous bacterial peritonitis, based on positive blood culture, urine culture, or chest x-ray (if positive, must have been on antibiotics for at least 24 hours prior to study entry)
boolean
C0009450 (UMLS CUI [1])
Acute pancreatitis
Item
acute pancreatitis (increased lipase > 3x uln or radiologic evidence)
boolean
C0001339 (UMLS CUI [1])
hepatitis b + c
Item
positivity for hepatitis b (hbsag+) or c virus (hcv+), and
boolean
C0149709 (UMLS CUI [1])
C0220847 (UMLS CUI [2])
C0220847 (UMLS CUI [2])
Kidney Failure
Item
renal failure
boolean
C0035078 (UMLS CUI [1])
concomitant disease
Item
other or concomitant cause of liver disease as a result of:
boolean
C0243087 (UMLS CUI [1])
Autoimmune liver disease
Item
autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer >1:160)
boolean
C0400936 (UMLS CUI [1])
Metabolic liver diseases
Item
metabolic liver disease (abnormal ceruloplasmin levels)
boolean
C0023895 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0311400 (UMLS CUI [1,2])
vascular liver disease
Item
vascular liver disease
boolean
C0023895 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
C1801960 (UMLS CUI [1,2])
Drug-Induced Liver Injury
Item
drug induced liver disease
boolean
C0860207 (UMLS CUI [1])
Sepsis
Item
sepsis as evidenced by positive blood or urine culture, pneumonia as confirmed by x-ray
boolean
C0243026 (UMLS CUI [1])
History of renal transplant
Item
history of renal transplant and/or on dialysis at time of entry into study
boolean
C0455641 (UMLS CUI [1])
systemic lupus erythematosus
Item
diagnosed or suspected systemic lupus erythematosus (sle) and/or rheumatoid arthritis (ra)
boolean
C0024141 (UMLS CUI [1])
Liver carcinoma
Item
hepatocellular carcinoma (hcc) at entry into the study
boolean
C2239176 (UMLS CUI [1])
Malignant Neoplasms
Item
active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
boolean
C0006826 (UMLS CUI [1])
Biopsy of liver
Item
liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis
boolean
C0193388 (UMLS CUI [1])