ID

20909

Beschrijving

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

Trefwoorden

  1. 27-03-17 27-03-17 -
Geüploaded op

27 maart 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :


Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hepatitis B NCT00426712

Eligibility Hepatitis B NCT00426712

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing and able to give written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
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
Beschrijving

Renal function Loss Progressive | Chronic kidney disease Chronic kidney disease NKF classification | Hemodialysis Expected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C1517945
UMLS CUI [1,3]
C0205329
UMLS CUI [2,1]
C1561643
UMLS CUI [2,2]
C2074730
UMLS CUI [3,1]
C0019004
UMLS CUI [3,2]
C1517001
body mass index of 31 or less
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
received previous vaccination with any hbv vaccine (1 or more doses)
Beschrijving

Vaccination Hepatitis B Vaccine Dose Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2240392
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1265611
any history of hbv infection
Beschrijving

Hepatitis B

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
pregnant or breast-feeding, or planning a pregnancy during the study
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
has autoimmune disease
Beschrijving

Autoimmune Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
diagnosis of chronic kidney failure due to autoimmune disease
Beschrijving

Chronic Kidney Failure Due to Autoimmune Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0004364
receiving hemodialysis treatment at the time of enrollment
Beschrijving

Hemodialysis

Datatype

boolean

Alias
UMLS CUI [1]
C0019004
received any blood products or antibodies within 3 months prior to study entry, or is likely to require blood products during the study
Beschrijving

Blood product | Antibodies

Datatype

boolean

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2]
C3495458
ever received an injection with dna plasmids or oligonucleotides
Beschrijving

Plasmid DNA Injection | Oligonucleotides Injection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032136
UMLS CUI [1,2]
C1828121
UMLS CUI [2,1]
C0028953
UMLS CUI [2,2]
C1828121
received erythropoietin within 7 days prior to the first study injection
Beschrijving

Erythropoietin

Datatype

boolean

Alias
UMLS CUI [1]
C0014822
received vaccination with any vaccines during the 4 weeks prior to study entry
Beschrijving

Vaccination Vaccine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0042210
received any other investigational medicinal agent during the 4 weeks prior to study entry
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230

Similar models

Eligibility Hepatitis B NCT00426712

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Body mass index
Item
body mass index of 31 or less
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
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])
Investigational New Drugs
Item
received any other investigational medicinal agent during the 4 weeks prior to study entry
boolean
C0013230 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial