ID

41139

Beschreibung

Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01456286

Link

https://clinicaltrials.gov/show/NCT01456286

Stichworte

Versionen (1)
  1. 30.06.20 30.06.20 -
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See clinicaltrials.gov

Hochgeladen am

30. Juni 2020

DOI

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Eligibility Liver Cirrhosis NCT01456286

Englisch

Eligibility Liver Cirrhosis NCT01456286

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
liver cirrhosis of any etiology diagnosed by biopsy or by clinical-imaging data
Beschreibung

Liver Cirrhosis Biopsy | Liver Cirrhosis Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0011923
male or female patients between 18-75 years old in whom hepatic vein catheterization is indicated.
Beschreibung

Age | Indication Catheterization of hepatic vein

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0191124
clinically significant portal hypertension defined by a hvpg ≥ 10 mmhg.
Beschreibung

Portal Hypertension | Hepatic venous pressure gradient

Datentyp

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C4049263
signed informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
end-stage liver failure defined by one of the following: prothrombin activity < 40% and/or bilirubin > 5 mg/dl.
Beschreibung

End-stage Liver Failure | Prothrombin time assay | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205088
UMLS CUI [1,2]
C0085605
UMLS CUI [2]
C0033707
UMLS CUI [3]
C1278039
pregnancy or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concomitant beginning of non-selective beta-blockers (propranolol, nadolol) during the administration of sapropterin. beta-blockers are not exclusion criteria if they are on stable doses in the previous 6 weeks.
Beschreibung

Beta blocking agents, non-selective | propranolol | nadolol

Datentyp

boolean

Alias
UMLS CUI [1]
C0304515
UMLS CUI [2]
C0033497
UMLS CUI [3]
C0027302
treatment with carvedilol or nitrates.
Beschreibung

carvedilol | Nitrates

Datentyp

boolean

Alias
UMLS CUI [1]
C0054836
UMLS CUI [2]
C0028125
previous tips or derivative shunt.
Beschreibung

TIPS | Shunt Similar

Datentyp

boolean

Alias
UMLS CUI [1]
C0339897
UMLS CUI [2,1]
C0813207
UMLS CUI [2,2]
C2348205
hepatocellular carcinoma exceeding milan criteria.
Beschreibung

Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
spontaneous bacterial peritonitis or any active infection when entering in the study.
Beschreibung

Bacterial peritonitis | Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0341503
UMLS CUI [2]
C0009450
portal vein thrombosis or cavernomatosis at ultrasound.
Beschreibung

Portal Vein Thrombosis Ultrasonography | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0041618
UMLS CUI [2]
C3846158
chronic heart failure, respiratory failure or chronic renal failure (creatinine >2 mg/dl).
Beschreibung

Chronic heart failure | Respiratory Failure | Kidney Failure, Chronic | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0264716
UMLS CUI [2]
C1145670
UMLS CUI [3]
C0022661
UMLS CUI [4]
C0201976
previous convulsions or epilepsy.
Beschreibung

Convulsions | Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C4048158
UMLS CUI [2]
C0014544
hypersensibility to sapropterin or any of its excipients.
Beschreibung

Hypersensitivity Sapropterin | Hypersensitivity Sapropterin Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0048897
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0048897
UMLS CUI [2,3]
C0015237
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Ähnliche Modelle

Eligibility Liver Cirrhosis NCT01456286

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver Cirrhosis Biopsy | Liver Cirrhosis Imaging
Item
liver cirrhosis of any etiology diagnosed by biopsy or by clinical-imaging data
boolean
C0023890 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Age | Indication Catheterization of hepatic vein
Item
male or female patients between 18-75 years old in whom hepatic vein catheterization is indicated.
boolean
C0001779 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0191124 (UMLS CUI [2,2])
Portal Hypertension | Hepatic venous pressure gradient
Item
clinically significant portal hypertension defined by a hvpg ≥ 10 mmhg.
boolean
C0020541 (UMLS CUI [1])
C4049263 (UMLS CUI [2])
Informed Consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
End-stage Liver Failure | Prothrombin time assay | Serum total bilirubin measurement
Item
end-stage liver failure defined by one of the following: prothrombin activity < 40% and/or bilirubin > 5 mg/dl.
boolean
C0205088 (UMLS CUI [1,1])
C0085605 (UMLS CUI [1,2])
C0033707 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Beta blocking agents, non-selective | propranolol | nadolol
Item
concomitant beginning of non-selective beta-blockers (propranolol, nadolol) during the administration of sapropterin. beta-blockers are not exclusion criteria if they are on stable doses in the previous 6 weeks.
boolean
C0304515 (UMLS CUI [1])
C0033497 (UMLS CUI [2])
C0027302 (UMLS CUI [3])
carvedilol | Nitrates
Item
treatment with carvedilol or nitrates.
boolean
C0054836 (UMLS CUI [1])
C0028125 (UMLS CUI [2])
TIPS | Shunt Similar
Item
previous tips or derivative shunt.
boolean
C0339897 (UMLS CUI [1])
C0813207 (UMLS CUI [2,1])
C2348205 (UMLS CUI [2,2])
Liver carcinoma
Item
hepatocellular carcinoma exceeding milan criteria.
boolean
C2239176 (UMLS CUI [1])
Bacterial peritonitis | Communicable Disease
Item
spontaneous bacterial peritonitis or any active infection when entering in the study.
boolean
C0341503 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Portal Vein Thrombosis Ultrasonography | Other Coding
Item
portal vein thrombosis or cavernomatosis at ultrasound.
boolean
C0155773 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Chronic heart failure | Respiratory Failure | Kidney Failure, Chronic | Creatinine measurement, serum
Item
chronic heart failure, respiratory failure or chronic renal failure (creatinine >2 mg/dl).
boolean
C0264716 (UMLS CUI [1])
C1145670 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Convulsions | Epilepsy
Item
previous convulsions or epilepsy.
boolean
C4048158 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Hypersensitivity Sapropterin | Hypersensitivity Sapropterin Excipient
Item
hypersensibility to sapropterin or any of its excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0048897 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0048897 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
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