ID

39648

Descrição

Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation; ODM derived from: https://clinicaltrials.gov/show/NCT01687257

Link

https://clinicaltrials.gov/show/NCT01687257

Palavras-chave

Versões (1)
  1. 08/02/2020 08/02/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 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.

Voltar para os comentários do modelo
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 NCT01687257

Inglês

Eligibility Hepatitis C NCT01687257

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic infection with hepatitis c with hcv rna > 1000 iu/ml
Descrição

Hepatitis C, Chronic | Hepatitis C virus RNA assay

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C1272251
individuals with cirrhosis with child-pugh score < 10
Descrição

Liver Cirrhosis | Child-Pugh - Total Score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C4055253
esophageal or gastric varices on endoscopy within 6 months prior to or at screening
Descrição

Esophageal Varices Endoscopy | Gastric Varices Endoscopy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0014867
UMLS CUI [1,2]
C0014245
UMLS CUI [2,1]
C0017145
UMLS CUI [2,2]
C0014245
hepatic venous pressure gradient (hvpg) > 6 mmhg
Descrição

Hepatic venous pressure gradient

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4049263
body mass index (bmi) ≥ 18 kg/m^2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
naïve to all nucleotides/nucleoside treatments for chronic hcv infection
Descrição

Nucleotides Absent Chronic Hepatitis C | Nucleosides Absent Chronic Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0028630
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0524910
UMLS CUI [2,1]
C0028621
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0524910
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
Descrição

Illness Serious Interferes with Therapeutic procedure | Illness Interferes with Therapeutic procedure | Serious mental illness Interferes with Therapeutic procedure | Mental disorder Interferes with Therapeutic procedure | Illness Serious Interferes with Assessment | Illness Interferes with Assessment | Serious mental illness Interferes with Assessment | Mental disorder Interferes with Assessment | Illness Serious Interferes with Compliance | Illness Interferes with Compliance | Serious mental illness Interferes with Compliance | Mental disorder Interferes with Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C3841614
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0087111
UMLS CUI [5,1]
C0221423
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0521102
UMLS CUI [5,4]
C1516048
UMLS CUI [6,1]
C0221423
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1516048
UMLS CUI [7,1]
C3841614
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C1516048
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C1516048
UMLS CUI [9,1]
C0221423
UMLS CUI [9,2]
C0205404
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C1321605
UMLS CUI [10,1]
C0221423
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C1321605
UMLS CUI [11,1]
C3841614
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C1321605
UMLS CUI [12,1]
C0004936
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C1321605
hiv or chronic hepatitis b virus (hbv) infection (hbsag positive)
Descrição

HIV Infection | Hepatitis B, Chronic | Hepatitis B surface antigen positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0149709
alpha-fetoprotein (afp) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
Descrição

Alpha one fetoprotein measurement | Exception Liver mass Imaging Negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201539
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0240225
UMLS CUI [2,3]
C0011923
UMLS CUI [2,4]
C1513916
refractory ascites as defined by requiring paracentesis > twice within 1 month prior to screening
Descrição

Refractory ascites | Requirement Paracentesis times per month

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3532188
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0034115
UMLS CUI [2,3]
C0556969
active variceal bleeding within 6 months of screening
Descrição

Bleeding varices

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0333106
expected survival of < 1 year
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
history of hepatorenal, or hepatopulmonary syndrome.
Descrição

Hepatorenal Syndrome | Hepatopulmonary Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019212
UMLS CUI [2]
C0600452
evidence of renal impairment (crcl < 50 ml/min)
Descrição

Renal Insufficiency | Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0373595
history of major organ transplantation, including liver transplant.
Descrição

Transplantation Organ Major | Transplantation of liver

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205164
UMLS CUI [2]
C0023911
Voltar ao início da página

Similar models

Eligibility Hepatitis C NCT01687257

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Hepatitis C virus RNA assay
Item
chronic infection with hepatitis c with hcv rna > 1000 iu/ml
boolean
C0524910 (UMLS CUI [1])
C1272251 (UMLS CUI [2])
Liver Cirrhosis | Child-Pugh - Total Score
Item
individuals with cirrhosis with child-pugh score < 10
boolean
C0023890 (UMLS CUI [1])
C4055253 (UMLS CUI [2])
Esophageal Varices Endoscopy | Gastric Varices Endoscopy
Item
esophageal or gastric varices on endoscopy within 6 months prior to or at screening
boolean
C0014867 (UMLS CUI [1,1])
C0014245 (UMLS CUI [1,2])
C0017145 (UMLS CUI [2,1])
C0014245 (UMLS CUI [2,2])
Hepatic venous pressure gradient
Item
hepatic venous pressure gradient (hvpg) > 6 mmhg
boolean
C4049263 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≥ 18 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Nucleotides Absent Chronic Hepatitis C | Nucleosides Absent Chronic Hepatitis C
Item
naïve to all nucleotides/nucleoside treatments for chronic hcv infection
boolean
C0028630 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0028621 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Illness Serious Interferes with Therapeutic procedure | Illness Interferes with Therapeutic procedure | Serious mental illness Interferes with Therapeutic procedure | Mental disorder Interferes with Therapeutic procedure | Illness Serious Interferes with Assessment | Illness Interferes with Assessment | Serious mental illness Interferes with Assessment | Mental disorder Interferes with Assessment | Illness Serious Interferes with Compliance | Illness Interferes with Compliance | Serious mental illness Interferes with Compliance | Mental disorder Interferes with Compliance
Item
have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C3841614 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0221423 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C1516048 (UMLS CUI [5,4])
C0221423 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1516048 (UMLS CUI [6,3])
C3841614 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C1516048 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1516048 (UMLS CUI [8,3])
C0221423 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C1321605 (UMLS CUI [9,4])
C0221423 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C1321605 (UMLS CUI [10,3])
C3841614 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C1321605 (UMLS CUI [11,3])
C0004936 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C1321605 (UMLS CUI [12,3])
HIV Infection | Hepatitis B, Chronic | Hepatitis B surface antigen positive
Item
hiv or chronic hepatitis b virus (hbv) infection (hbsag positive)
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Alpha one fetoprotein measurement | Exception Liver mass Imaging Negative
Item
alpha-fetoprotein (afp) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
boolean
C0201539 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0240225 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C1513916 (UMLS CUI [2,4])
Refractory ascites | Requirement Paracentesis times per month
Item
refractory ascites as defined by requiring paracentesis > twice within 1 month prior to screening
boolean
C3532188 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0034115 (UMLS CUI [2,2])
C0556969 (UMLS CUI [2,3])
Bleeding varices
Item
active variceal bleeding within 6 months of screening
boolean
C0333106 (UMLS CUI [1])
Life Expectancy
Item
expected survival of < 1 year
boolean
C0023671 (UMLS CUI [1])
Hepatorenal Syndrome | Hepatopulmonary Syndrome
Item
history of hepatorenal, or hepatopulmonary syndrome.
boolean
C0019212 (UMLS CUI [1])
C0600452 (UMLS CUI [2])
Renal Insufficiency | Creatinine clearance measurement
Item
evidence of renal impairment (crcl < 50 ml/min)
boolean
C1565489 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Transplantation Organ Major | Transplantation of liver
Item
history of major organ transplantation, including liver transplant.
boolean
C0040732 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0023911 (UMLS CUI [2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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