ID

44421

Descrição

Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00737594

Link

https://clinicaltrials.gov/show/NCT00737594

Palavras-chave

Versões (2)
  1. 28/08/2018 28/08/2018 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Portal Hypertension NCT00737594

Inglês

Eligibility Portal Hypertension NCT00737594

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is >= 18 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
Descrição

Portal Hypertension intrahepatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020541
UMLS CUI [1,2]
C1512948
patient has clinical diagnosis of cirrhosis.
Descrição

Liver Cirrhosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023890
patient has undergone variceal banding.
Descrição

Variceal Banding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4288030
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a child-pugh score >12.
Descrição

Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4050412
patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or budd-chiari syndrome.
Descrição

Portal Hypertension Due to Hepatic Vein Thrombosis | Portal Hypertension Due to Portal vein obstruction | Portal Hypertension Due to Schistosomiasis | Portal Hypertension Due to Portal vein thrombosis | Portal Hypertension Due to Splenic vein thrombosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020541
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019154
UMLS CUI [2,1]
C0020541
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0265029
UMLS CUI [3,1]
C0020541
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0036323
UMLS CUI [4,1]
C0020541
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0155773
UMLS CUI [5,1]
C0020541
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0272416
variceal banding procedure was performed within 1 month of the screening visit.
Descrição

Variceal Banding Recently Screening

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4288030
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0220908
patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
Descrição

Bleeding varices | Bleeding varices Recurrent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0333106
UMLS CUI [2,1]
C0333106
UMLS CUI [2,2]
C2945760
patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
Descrição

Vasoactive agent Discontinue Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0597639
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
patient has hepatocellular carcinoma that is being medically treated or is advanced.
Descrição

Liver carcinoma Treated | Advanced Adult Hepatocellular Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1522326
UMLS CUI [2]
C1706732
patient has impaired renal function (i.e., serum creatinine concentration >1.8 mg/dl)
Descrição

Renal Insufficiency | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
Descrição

Transplantation of liver | Transplantation of liver Expected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2,1]
C0023911
UMLS CUI [2,2]
C1517001
patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the screening visit, or has had a bowel resection at any time.
Descrição

Gastrointestinal Surgical Procedure | Operation on abdominal region | Bowel resection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524722
UMLS CUI [2]
C0198482
UMLS CUI [3]
C0741614
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Similar models

Eligibility Portal Hypertension NCT00737594

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is >= 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Portal Hypertension intrahepatic
Item
patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
boolean
C0020541 (UMLS CUI [1,1])
C1512948 (UMLS CUI [1,2])
Liver Cirrhosis
Item
patient has clinical diagnosis of cirrhosis.
boolean
C0023890 (UMLS CUI [1])
Variceal Banding
Item
patient has undergone variceal banding.
boolean
C4288030 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Child-Pugh Classification
Item
patient has a child-pugh score >12.
boolean
C4050412 (UMLS CUI [1])
Portal Hypertension Due to Hepatic Vein Thrombosis | Portal Hypertension Due to Portal vein obstruction | Portal Hypertension Due to Schistosomiasis | Portal Hypertension Due to Portal vein thrombosis | Portal Hypertension Due to Splenic vein thrombosis
Item
patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or budd-chiari syndrome.
boolean
C0020541 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019154 (UMLS CUI [1,3])
C0020541 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0265029 (UMLS CUI [2,3])
C0020541 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0036323 (UMLS CUI [3,3])
C0020541 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0155773 (UMLS CUI [4,3])
C0020541 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0272416 (UMLS CUI [5,3])
Variceal Banding Recently Screening
Item
variceal banding procedure was performed within 1 month of the screening visit.
boolean
C4288030 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
Bleeding varices | Bleeding varices Recurrent
Item
patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
boolean
C0333106 (UMLS CUI [1])
C0333106 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
Vasoactive agent Discontinue Unwilling
Item
patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
boolean
C0597639 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Liver carcinoma Treated | Advanced Adult Hepatocellular Carcinoma
Item
patient has hepatocellular carcinoma that is being medically treated or is advanced.
boolean
C2239176 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1706732 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum
Item
patient has impaired renal function (i.e., serum creatinine concentration >1.8 mg/dl)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Transplantation of liver | Transplantation of liver Expected
Item
patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
boolean
C0023911 (UMLS CUI [1])
C0023911 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Gastrointestinal Surgical Procedure | Operation on abdominal region | Bowel resection
Item
patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the screening visit, or has had a bowel resection at any time.
boolean
C0524722 (UMLS CUI [1])
C0198482 (UMLS CUI [2])
C0741614 (UMLS CUI [3])
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