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ID
29690
Beschreibung
Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Positive Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00921180
Link
https://clinicaltrials.gov/show/NCT00921180
Stichworte
Versionen (2)
- 12.04.18 12.04.18 -
- 27.09.21 27.09.21 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
12. April 2018
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT00921180
Eligibility Hepatitis B, Chronic NCT00921180
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Hepatitis B, Chronic NCT00921180
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Hepatitis B, Chronic | Hepatitis B Surface Antigens Presence | Hepatitis B e Antigens persistent
Item
chronic hepatitis b (presence of hbsag > 6 months) with hbeag persistence for more than 3 months
boolean
C0524909 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0019167 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0019167 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
Age
Item
age older than 18 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis B DNA Measurement Quantity
Item
hbv dna > 20,000 iu/ml for more than 2 occasions
boolean
C3641250 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
ALT level raised
Item
serum alt levels between 2 to 10 folds the upper limit of normal (uln)
boolean
C1443982 (UMLS CUI [1])
Biopsy of liver Consistent with Chronic Hepatitis B
Item
a liver biopsy compatible with chronic hepatitis b
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524909 (UMLS CUI [1,3])
C0332290 (UMLS CUI [1,2])
C0524909 (UMLS CUI [1,3])
Anemia | Hemoglobin measurement | Gender
Item
anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Neutropenia | Neutrophil count
Item
neutropenia (neutrophil count <1,500 per cubic milliliter)
boolean
C0027947 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0200633 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement
Item
thrombocytopenia (platelet <90,000 per cubic milliliter)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0032181 (UMLS CUI [2])
HBV coinfection | HDV Coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Alcoholic Intoxication, Chronic | Alcohol consumption grams per day
Item
chronic alcohol abuse (daily consumption > 20 gram per day)
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Decompensated liver disease Child-Pugh Classification
Item
decompensated liver disease (child-pugh class b or c)
boolean
C4075847 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,2])
Serum creatinine raised
Item
serum creatinine level more than 1.5 times the upper limit of normal
boolean
C0700225 (UMLS CUI [1])
Autoimmune liver disease
Item
autoimmune liver disease
boolean
C0400936 (UMLS CUI [1])
Neoplastic disease
Item
neoplastic disease
boolean
C1882062 (UMLS CUI [1])
Organ Transplantation
Item
an organ transplant
boolean
C0029216 (UMLS CUI [1])
Therapeutic immunosuppression
Item
immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1])
Autoimmune Diseases Poorly controlled | Lung diseases Poorly controlled | Heart Diseases Poorly controlled | Mental disorders Poorly controlled | Nervous system disorder Poorly controlled | Poorly controlled diabetes mellitus | Drug abuse
Item
poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus evidence of drug abuse
boolean
C0004364 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0027765 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0554876 (UMLS CUI [6])
C0013146 (UMLS CUI [7])
C3853134 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0027765 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0554876 (UMLS CUI [6])
C0013146 (UMLS CUI [7])
Contraceptive methods Unwilling
Item
unwilling to have contraception
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,2])
Allergic Reaction Entecavir | Allergic Reaction Peginterferon alfa-2a
Item
known allergic reaction to entecavir or peginterferon alfa-2a
boolean
C1527304 (UMLS CUI [1,1])
C0971023 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0391001 (UMLS CUI [2,2])
C0971023 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0391001 (UMLS CUI [2,2])
Informed Consent Unwilling
Item
unwilling to sign inform consent
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,2])