Informações:
Falhas:
ID
14035
Descrição
Comparison of Combination Therapy of Corticosteroids and Bovine Colostrum Versus Corticosteroids and Placebo: Randomized Double Blind Placebo Controlled Trial in Treatment of Severe Alcoholic Hepatitis; ODM derived from: https://clinicaltrials.gov/show/NCT02473341
Link
https://clinicaltrials.gov/show/NCT02473341
Palavras-chave
Versões (1)
- 22/03/2016 22/03/2016 -
Transferido a
22 de março de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Alcoholic Hepatitis NCT02473341
Eligibility Alcoholic Hepatitis NCT02473341
- StudyEvent: Eligibility
Similar models
Eligibility Alcoholic Hepatitis NCT02473341
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
alcoholic hepatitis
Item
alcoholic hepatitis
boolean
C0019187 (UMLS CUI [1])
Icterus
Item
jaundice < 3 months
boolean
C0022346 (UMLS CUI [1])
Liver Failure
Item
first liver decompensating event
boolean
C0085605 (UMLS CUI [1])
Bilirubin
Item
bilirubin > 5 mg/dl
boolean
C0005437 (UMLS CUI [1])
INR
Item
pti (inr) increased
boolean
C0853225 (UMLS CUI [1])
Neutrophilia
Item
neutrophilia
boolean
C0151683 (UMLS CUI [1])
ast
Item
ast< 300 iu/l ; ast/alt >2
boolean
C0004002 (UMLS CUI [1])
hepatic encephalopathy
Item
hepatic encephalopathy
boolean
C0019151 (UMLS CUI [1])
Age
Item
men and women age > 18 years and above
boolean
C0001779 (UMLS CUI [1])
Meld
Item
df≥32 or meld≥20
boolean
C1718072 (UMLS CUI [1])
Alcohol consumption
Item
actively consuming alcohol within 6 weeks of entry into the study
boolean
C0001948 (UMLS CUI [1])
upper gi bleed
Item
patient with controlled upper gi bleed, resolved sepsis and acute kidney injury can be enrolled
boolean
C0041909 (UMLS CUI [1])
liver biopsy
Item
liver biopsy (as many as possible)
boolean
C0193388 (UMLS CUI [1])
Informed Consent
Item
failure to obtain informed consent
boolean
C0021430 (UMLS CUI [1])
jaundice more then 3 months
Item
jaundice more then 3 months
boolean
C0745473 (UMLS CUI [1])
Aspartate Transaminase
Item
ast>300 iu/l
boolean
C0004002 (UMLS CUI [1])
Sepsis
Item
active infection or sepsis
boolean
C0243026 (UMLS CUI [1])
concomitant causes of liver disease
Item
other concomitant causes of liver disease: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease
boolean
C0243087 (UMLS CUI [1])
hiv positive
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
FOOD ALLERGY TO LACTOSE
Item
cow milk allergy or severe lactose intolerance
boolean
C0744078 (UMLS CUI [1])
Acute gastrointestinal hemorrhage
Item
active gastrointestinal bleeding.
boolean
C0266807 (UMLS CUI [1])
Kidney Failure, Acute
Item
acute kidney injury at time of randomization with creatinine > 1.5 mg/dl
boolean
C0022660 (UMLS CUI [1])
acute pancreatitis
Item
evidence of acute pancreatitis or biliary obstruction
boolean
C0001339 (UMLS CUI [1])
Patient pregnant
Item
subjects who are pregnant or lactating
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
C2828358 (UMLS CUI [2])
Cardiopulmonary disease
Item
Significant systemic cardio-pulmonary illness
boolean
C0553534 (UMLS CUI [1])
Vasoconstrictor Agents
Item
patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization
boolean
C0042397 (UMLS CUI [1])
Treatment for alcoholic hepatitis
Item
treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use>1 week.
boolean
C0019187 (UMLS CUI [1])
Investigational Drugs
Item
any patient who has received any investigational drug or device within 30 days entering into the study.
boolean
C0013230 (UMLS CUI [1])