ID

39287

Beschreibung

Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT01951677

Link

https://clinicaltrials.gov/show/NCT01951677

Stichworte

Versionen (1)
  1. 16.12.19 16.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Dezember 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Exposure to Hepatitis B Virus NCT01951677

Englisch

Eligibility Exposure to Hepatitis B Virus NCT01951677

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years and above
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
male or female
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
able to provide written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
willing and able to comply with the protocol for the duration of the study.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
has one or more of
Beschreibung

Criteria Quantity Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
age 40 years or above
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
impaired renal function (creatinine >120 mmol/l or calculated glomerular filtration rate <60mls/min)
Beschreibung

Renal Insufficiency | Creatinine measurement, serum | Glomerular Filtration Rate Calculated

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0017654
UMLS CUI [3,2]
C0444686
diagnosis of diabetes mellitus (any type)
Beschreibung

Diabetes Mellitus Type Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of prior hepatitis b vaccination
Beschreibung

Hepatitis B vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C0474232
history of serious vaccine allergy if in the opinion of the investigator this represents a contraindication to hepatitis b vaccination
Beschreibung

Vaccines allergy Serious | Medical contraindication Hepatitis B vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0571550
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0474232
women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device.
Beschreibung

Childbearing Potential | Exception Use of Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Contraception, Barrier

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0700589
UMLS CUI [3]
C0009905
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0004764
pregnant or lactating women.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of systemic autoimmune disease including wegener's granulomatosis, systemic lupus erythematosus, guillain-barre, scleroderma or multiple sclerosis.
Beschreibung

Systemic autoimmune disease | Wegener's Granulomatosis | Lupus Erythematosus, Systemic | Guillain-Barre Syndrome | Scleroderma | Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C2895206
UMLS CUI [2]
C3495801
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0018378
UMLS CUI [5]
C0011644
UMLS CUI [6]
C0026769
participation in another clinical trial with an investigational agent within 28 days of the scheduled date of first immunization.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
any other serious medical, social or mental condition that, in the opinion of the investigator, would be detrimental to the subjects or the study.
Beschreibung

Medical condition Serious Impairing Study Subject | Medical condition Serious Impairing Clinical Trial | Social Condition Impairing Study Subject | Social Condition Impairing Clinical Trial | Mental condition Impairing Study Subject | Mental condition Impairing Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0221099
UMLS CUI [1,4]
C0681850
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0221099
UMLS CUI [2,4]
C0008976
UMLS CUI [3,1]
C0037403
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C0681850
UMLS CUI [4,1]
C0037403
UMLS CUI [4,2]
C0221099
UMLS CUI [4,3]
C0008976
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0221099
UMLS CUI [5,3]
C0681850
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0221099
UMLS CUI [6,3]
C0008976
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Ähnliche Modelle

Eligibility Exposure to Hepatitis B Virus NCT01951677

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years and above
boolean
C0001779 (UMLS CUI [1])
Gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
Informed Consent
Item
able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with the protocol for the duration of the study.
boolean
C0525058 (UMLS CUI [1])
Criteria Quantity Fulfill
Item
has one or more of
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Age
Item
age 40 years or above
boolean
C0001779 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum | Glomerular Filtration Rate Calculated
Item
impaired renal function (creatinine >120 mmol/l or calculated glomerular filtration rate <60mls/min)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0017654 (UMLS CUI [3,1])
C0444686 (UMLS CUI [3,2])
Diabetes Mellitus Type Any
Item
diagnosis of diabetes mellitus (any type)
boolean
C0011849 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis B vaccination
Item
history of prior hepatitis b vaccination
boolean
C0474232 (UMLS CUI [1])
Vaccines allergy Serious | Medical contraindication Hepatitis B vaccination
Item
history of serious vaccine allergy if in the opinion of the investigator this represents a contraindication to hepatitis b vaccination
boolean
C0571550 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0474232 (UMLS CUI [2,2])
Childbearing Potential | Exception Use of Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Contraception, Barrier
Item
women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device.
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0009905 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic autoimmune disease | Wegener's Granulomatosis | Lupus Erythematosus, Systemic | Guillain-Barre Syndrome | Scleroderma | Multiple Sclerosis
Item
history of systemic autoimmune disease including wegener's granulomatosis, systemic lupus erythematosus, guillain-barre, scleroderma or multiple sclerosis.
boolean
C2895206 (UMLS CUI [1])
C3495801 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0018378 (UMLS CUI [4])
C0011644 (UMLS CUI [5])
C0026769 (UMLS CUI [6])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another clinical trial with an investigational agent within 28 days of the scheduled date of first immunization.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Medical condition Serious Impairing Study Subject | Medical condition Serious Impairing Clinical Trial | Social Condition Impairing Study Subject | Social Condition Impairing Clinical Trial | Mental condition Impairing Study Subject | Mental condition Impairing Clinical Trial
Item
any other serious medical, social or mental condition that, in the opinion of the investigator, would be detrimental to the subjects or the study.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0037403 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0681850 (UMLS CUI [3,3])
C0037403 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
C0681850 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0221099 (UMLS CUI [6,2])
C0008976 (UMLS CUI [6,3])
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