ID

44421

Description

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

Link

https://clinicaltrials.gov/show/NCT00737594

Keywords

Versions (2)
  1. 8/28/18 8/28/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Portal Hypertension NCT00737594

English

Eligibility Portal Hypertension NCT00737594

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

Portal Hypertension intrahepatic

Data type

boolean

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

Liver Cirrhosis

Data type

boolean

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

Variceal Banding

Data type

boolean

Alias
UMLS CUI [1]
C4288030
Exclusion Criteria
Description

Exclusion Criteria

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

Child-Pugh Classification

Data type

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.
Description

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

Data type

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.
Description

Variceal Banding Recently Screening

Data type

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.
Description

Bleeding varices | Bleeding varices Recurrent

Data type

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.
Description

Vasoactive agent Discontinue Unwilling

Data type

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.
Description

Liver carcinoma Treated | Advanced Adult Hepatocellular Carcinoma

Data type

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)
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

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.
Description

Transplantation of liver | Transplantation of liver Expected

Data type

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.
Description

Gastrointestinal Surgical Procedure | Operation on abdominal region | Bowel resection

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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