ID

44421

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00737594

Nyckelord

Versioner (2)
  1. 2018-08-28 2018-08-28 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Portal Hypertension NCT00737594

Engelsk

Eligibility Portal Hypertension NCT00737594

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Portal Hypertension intrahepatic

Datatyp

boolean

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

Liver Cirrhosis

Datatyp

boolean

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

Variceal Banding

Datatyp

boolean

Alias
UMLS CUI [1]
C4288030
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Child-Pugh Classification

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Variceal Banding Recently Screening

Datatyp

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.
Beskrivning

Bleeding varices | Bleeding varices Recurrent

Datatyp

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.
Beskrivning

Vasoactive agent Discontinue Unwilling

Datatyp

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.
Beskrivning

Liver carcinoma Treated | Advanced Adult Hepatocellular Carcinoma

Datatyp

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)
Beskrivning

Renal Insufficiency | Creatinine measurement, serum

Datatyp

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.
Beskrivning

Transplantation of liver | Transplantation of liver Expected

Datatyp

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.
Beskrivning

Gastrointestinal Surgical Procedure | Operation on abdominal region | Bowel resection

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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