ID

44559

Beschreibung

A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00498212

Link

https://clinicaltrials.gov/show/NCT00498212

Stichworte

Versionen (2)
  1. 09.04.18 09.04.18 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00498212

Englisch

Eligibility Hepatitis B NCT00498212

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
have a glomerular filtration rate (gfr) ≤ 45 ml/min
Beschreibung

Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0017654
have an expectation of going on hemodialysis or are already on hemodialysis
Beschreibung

Hemodialysis Expected | Hemodialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C1517001
UMLS CUI [2]
C0019004
is serum negative for hepatitis b virus (hbv) antibodies, hepatitis c virus (hcv), and human immunodeficiency virus (hiv)
Beschreibung

Hepatitis B Antibodies Seronegative | Hepatitis C virus Seronegative | HIV Seronegative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019164
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0220847
UMLS CUI [2,2]
C0521144
UMLS CUI [3,1]
C0019682
UMLS CUI [3,2]
C0521144
have repeated resting blood pressure measurements ≤ 165/105 mmhg
Beschreibung

Blood pressure measurement At rest Repeated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0443144
UMLS CUI [1,3]
C0205341
women of childbearing potential must be consistently using a highly effective method of birth control
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant, breastfeeding or planning a pregnancy
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
any previous hbv infection
Beschreibung

Hepatitis B Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0205156
previous vaccination (1 or more doses) with any hbv vaccine
Beschreibung

Hepatitis B vaccination Dose Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
any previous autoimmune diseases
Beschreibung

Autoimmune Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
have a diagnosis of chronic renal failure due to autoimmune disease
Beschreibung

Chronic Kidney Failure Due to Autoimmune Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0004364
are at high risk for recent exposure to hbv, hcv or hiv
Beschreibung

High risk Exposure to Hepatitis B Virus | High risk Exposure to Hepatitis C virus | High risk Exposure to HIV

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0019169
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0220847
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0332157
UMLS CUI [3,3]
C0019682
received any antibodies within 3 months prior to study entry
Beschreibung

Antibodies (medication)

Datentyp

boolean

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

Plasmids Injection | Oligonucleotides Injection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032136
UMLS CUI [1,2]
C1828121
UMLS CUI [2,1]
C0028953
UMLS CUI [2,2]
C1828121
received any vaccines within 4 weeks prior to study entry
Beschreibung

Vaccines

Datentyp

boolean

Alias
UMLS CUI [1]
C0042210
received any other investigational medicinal agent within 4 weeks prior to study entry
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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Ähnliche Modelle

Eligibility Hepatitis B NCT00498212

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willing and able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Glomerular Filtration Rate
Item
have a glomerular filtration rate (gfr) ≤ 45 ml/min
boolean
C0017654 (UMLS CUI [1])
Hemodialysis Expected | Hemodialysis
Item
have an expectation of going on hemodialysis or are already on hemodialysis
boolean
C0019004 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0019004 (UMLS CUI [2])
Hepatitis B Antibodies Seronegative | Hepatitis C virus Seronegative | HIV Seronegative
Item
is serum negative for hepatitis b virus (hbv) antibodies, hepatitis c virus (hcv), and human immunodeficiency virus (hiv)
boolean
C0019164 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0220847 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C0019682 (UMLS CUI [3,1])
C0521144 (UMLS CUI [3,2])
Blood pressure measurement At rest Repeated
Item
have repeated resting blood pressure measurements ≤ 165/105 mmhg
boolean
C0005824 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must be consistently using a highly effective method of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, breastfeeding or planning a pregnancy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Hepatitis B Previous
Item
any previous hbv infection
boolean
C0019163 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Hepatitis B vaccination Dose Quantity
Item
previous vaccination (1 or more doses) with any hbv vaccine
boolean
C0474232 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Autoimmune Diseases
Item
any previous autoimmune diseases
boolean
C0004364 (UMLS CUI [1])
Chronic Kidney Failure Due to Autoimmune Diseases
Item
have a diagnosis of chronic renal failure due to autoimmune disease
boolean
C0022661 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,3])
High risk Exposure to Hepatitis B Virus | High risk Exposure to Hepatitis C virus | High risk Exposure to HIV
Item
are at high risk for recent exposure to hbv, hcv or hiv
boolean
C0332167 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0019169 (UMLS CUI [1,3])
C0332167 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0332167 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0019682 (UMLS CUI [3,3])
Antibodies (medication)
Item
received any antibodies within 3 months prior to study entry
boolean
C3495458 (UMLS CUI [1])
Plasmids 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])
Vaccines
Item
received any vaccines within 4 weeks prior to study entry
boolean
C0042210 (UMLS CUI [1])
Investigational New Drugs
Item
received any other investigational medicinal agent within 4 weeks prior to study entry
boolean
C0013230 (UMLS CUI [1])
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