Informações:
Falhas:
ID
20909
Descrição
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00426712
Link
https://clinicaltrials.gov/show/NCT00426712
Palavras-chave
Versões (1)
- 27/03/2017 27/03/2017 -
Transferido a
27 de março de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00426712
Eligibility Hepatitis B NCT00426712
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT00426712
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Informed Consent
Item
willing and able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Renal function Loss Progressive | Chronic kidney disease Chronic kidney disease NKF classification | Hemodialysis Expected
Item
progressive loss of kidney function with more advanced stage 3 (gfr at least 45 ml/min) or stage 4 chronic kidney disease by national kidney foundation classification, and are expected to eventually go on hemodialysis
boolean
C0232804 (UMLS CUI [1,1])
C1517945 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
C1561643 (UMLS CUI [2,1])
C2074730 (UMLS CUI [2,2])
C0019004 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C1517945 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
C1561643 (UMLS CUI [2,1])
C2074730 (UMLS CUI [2,2])
C0019004 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Body mass index
Item
body mass index of 31 or less
boolean
C1305855 (UMLS CUI [1])
Vaccination Hepatitis B Vaccine Dose Quantity
Item
received previous vaccination with any hbv vaccine (1 or more doses)
boolean
C0042196 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C2240392 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Hepatitis B
Item
any history of hbv infection
boolean
C0019163 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant or breast-feeding, or planning a pregnancy during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Autoimmune Disease
Item
has autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Chronic Kidney Failure Due to Autoimmune Disease
Item
diagnosis of chronic kidney failure due to autoimmune disease
boolean
C0022661 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,3])
Hemodialysis
Item
receiving hemodialysis treatment at the time of enrollment
boolean
C0019004 (UMLS CUI [1])
Blood product | Antibodies
Item
received any blood products or antibodies within 3 months prior to study entry, or is likely to require blood products during the study
boolean
C0456388 (UMLS CUI [1])
C3495458 (UMLS CUI [2])
C3495458 (UMLS CUI [2])
Plasmid DNA Injection | Oligonucleotides Injection
Item
ever received an injection with dna plasmids or oligonucleotides
boolean
C0032136 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0028953 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C1828121 (UMLS CUI [1,2])
C0028953 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
Erythropoietin
Item
received erythropoietin within 7 days prior to the first study injection
boolean
C0014822 (UMLS CUI [1])
Vaccination Vaccine
Item
received vaccination with any vaccines during the 4 weeks prior to study entry
boolean
C0042196 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Investigational New Drugs
Item
received any other investigational medicinal agent during the 4 weeks prior to study entry
boolean
C0013230 (UMLS CUI [1])
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