Eligibility Liver Cirrhosis NCT01456286

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