ID

14035

Beschrijving

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

Trefwoorden

  1. 22-03-16 22-03-16 -
Geüploaded op

22 maart 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Alcoholic Hepatitis NCT02473341

Eligibility Alcoholic Hepatitis NCT02473341

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
alcoholic hepatitis
Beschrijving

alcoholic hepatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0019187
jaundice < 3 months
Beschrijving

Icterus

Datatype

boolean

Alias
UMLS CUI [1]
C0022346
first liver decompensating event
Beschrijving

Liver Failure

Datatype

boolean

Alias
UMLS CUI [1]
C0085605
bilirubin > 5 mg/dl
Beschrijving

Bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0005437
pti (inr) increased
Beschrijving

INR

Datatype

boolean

Alias
UMLS CUI [1]
C0853225
neutrophilia
Beschrijving

Neutrophilia

Datatype

boolean

Alias
UMLS CUI [1]
C0151683
ast< 300 iu/l ; ast/alt >2
Beschrijving

ast

Datatype

boolean

Alias
UMLS CUI [1]
C0004002
hepatic encephalopathy
Beschrijving

hepatic encephalopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0019151
men and women age > 18 years and above
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
df≥32 or meld≥20
Beschrijving

Meld

Datatype

boolean

Alias
UMLS CUI [1]
C1718072
actively consuming alcohol within 6 weeks of entry into the study
Beschrijving

Alcohol consumption

Datatype

boolean

Alias
UMLS CUI [1]
C0001948
patient with controlled upper gi bleed, resolved sepsis and acute kidney injury can be enrolled
Beschrijving

upper gi bleed

Datatype

boolean

Alias
UMLS CUI [1]
C0041909
liver biopsy (as many as possible)
Beschrijving

liver biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0193388
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
failure to obtain informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
jaundice more then 3 months
Beschrijving

jaundice more then 3 months

Datatype

boolean

Alias
UMLS CUI [1]
C0745473
ast>300 iu/l
Beschrijving

Aspartate Transaminase

Datatype

boolean

Alias
UMLS CUI [1]
C0004002
active infection or sepsis
Beschrijving

Sepsis

Datatype

boolean

Alias
UMLS CUI [1]
C0243026
other concomitant causes of liver disease: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease
Beschrijving

concomitant causes of liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0243087
hiv positive
Beschrijving

hiv positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
cow milk allergy or severe lactose intolerance
Beschrijving

FOOD ALLERGY TO LACTOSE

Datatype

boolean

Alias
UMLS CUI [1]
C0744078
active gastrointestinal bleeding.
Beschrijving

Acute gastrointestinal hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0266807
acute kidney injury at time of randomization with creatinine > 1.5 mg/dl
Beschrijving

Kidney Failure, Acute

Datatype

boolean

Alias
UMLS CUI [1]
C0022660
evidence of acute pancreatitis or biliary obstruction
Beschrijving

acute pancreatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0001339
subjects who are pregnant or lactating
Beschrijving

Patient pregnant

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
Significant systemic cardio-pulmonary illness
Beschrijving

Cardiopulmonary disease

Datatype

boolean

Alias
UMLS CUI [1]
C0553534
patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization
Beschrijving

Vasoconstrictor Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0042397
treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use>1 week.
Beschrijving

Treatment for alcoholic hepatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0019187
any patient who has received any investigational drug or device within 30 days entering into the study.
Beschrijving

Investigational Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230

Similar models

Eligibility Alcoholic Hepatitis NCT02473341

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial