Informações:
Falhas:
ID
39700
Descrição
Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes; ODM derived from: https://clinicaltrials.gov/show/NCT01226797
Link
https://clinicaltrials.gov/show/NCT01226797
Palavras-chave
Versões (1)
- 10/02/2020 10/02/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
10 de fevereiro de 2020
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility Hepatitis C, Chronic NCT01226797
Eligibility Hepatitis C, Chronic NCT01226797
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C, Chronic NCT01226797
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Hepatitis C, Chronic
Item
chronic hcv infection
boolean
C0524910 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alt >1.5 but <10 times upper limit of normal
boolean
C0151905 (UMLS CUI [1])
Decompensated liver disease | Liver disease Severe
Item
decompensated or severe liver disease defined by one or more of the following criteria:
boolean
C4075847 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Liver Cirrhosis Biopsy of liver
Item
prior liver biopsy showing cirrhosis.
boolean
C0023890 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
INR raised
Item
international normalized ratio (inr) greater than or equal to 1.5.
boolean
C0853225 (UMLS CUI [1])
Elevated total bilirubin | Elevated serum unconjugated bilirubin
Item
total bilirubin greater than or equal to 1.5x uln, or >2x uln for unconjugated bilirubin.
boolean
C0741494 (UMLS CUI [1])
C0241024 (UMLS CUI [2])
C0241024 (UMLS CUI [2])
Serum albumin level decreased below normal
Item
serum albumin below normal.
boolean
C3665623 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or aspartate aminotransferase (ast) >10 x uln.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151904 (UMLS CUI [2])
Hypertension, Portal | Splenomegaly | Ascites | Encephalopathy | Esophageal Varices
Item
evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.
boolean
C0020541 (UMLS CUI [1])
C0038002 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0085584 (UMLS CUI [4])
C0014867 (UMLS CUI [5])
C0038002 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0085584 (UMLS CUI [4])
C0014867 (UMLS CUI [5])
HIV Present
Item
presence of human immunodeficiency virus (hiv).
boolean
C0019682 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
HBV coinfection
Item
co-infection with hepatitis b virus (hbv).
boolean
C2242656 (UMLS CUI [1])
Coinfection Epstein-Barr Virus | Coinfection Cytomegalovirus
Item
co-infection with epstein barr virus (ebv) and/or cytomegalovirus (cmv).
boolean
C0275524 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0010825 (UMLS CUI [2,2])
C0014644 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0010825 (UMLS CUI [2,2])