ID

14081

Descripción

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

Palabras clave

Versiones (1)
  1. 28/3/16 28/3/16 -
Subido en

28 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Alcoholic Hepatitis NCT01912404

Inglés

Eligibility Alcoholic Hepatitis NCT01912404

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients 21 years of age or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients with alcoholic hepatitis defined as:
Descripción

alcoholic hepatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019187
history of heavy alcohol abuse use: >40 g/day in females and >60 g/day in males for a minimum period of 6 months
Descripción

heavy alcohol abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0740861
consumed alcohol within 6 weeks of entry into the study
Descripción

alcohol consumed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3700016
biochemical parameters of severe disease as evidenced by meld score >20 but <35, or meld score 35-40 if the sofa score is <10
Descripción

severe disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1718072
UMLS CUI [2]
C3494459
patients with established contraindications to steroid use including but not limited to the following:
Descripción

Steroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038317
gi bleed
Descripción

Gastrointestinal Hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017181
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)
Descripción

infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
acute pancreatitis (increased lipase > 3x uln or radiologic evidence)
Descripción

Acute pancreatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001339
positivity for hepatitis b (hbsag+) or c virus (hcv+), and
Descripción

hepatitis b + c

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0220847
renal failure
Descripción

Kidney Failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035078
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
other or concomitant cause of liver disease as a result of:
Descripción

concomitant disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0243087
autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer >1:160)
Descripción

Autoimmune liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0400936
metabolic liver disease (abnormal ceruloplasmin levels)
Descripción

Metabolic liver diseases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0311400
vascular liver disease
Descripción

vascular liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C1801960
drug induced liver disease
Descripción

Drug-Induced Liver Injury

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0860207
sepsis as evidenced by positive blood or urine culture, pneumonia as confirmed by x-ray
Descripción

Sepsis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0243026
history of renal transplant and/or on dialysis at time of entry into study
Descripción

History of renal transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0455641
diagnosed or suspected systemic lupus erythematosus (sle) and/or rheumatoid arthritis (ra)
Descripción

systemic lupus erythematosus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024141
hepatocellular carcinoma (hcc) at entry into the study
Descripción

Liver carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis
Descripción

Biopsy of liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0193388
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Similar models

Eligibility Alcoholic Hepatitis NCT01912404

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Kidney Failure
Item
renal failure
boolean
C0035078 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
vascular liver disease
Item
vascular liver disease
boolean
C0023895 (UMLS CUI [1,1])
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])
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