ID

14918

Beskrivning

The Effect of Previous Pneumococcal Immunization on the Immune Response of Patients With Severe CKD to Prevnar 13; ODM derived from: https://clinicaltrials.gov/show/NCT02370069

Länk

https://clinicaltrials.gov/show/NCT02370069

Nyckelord

Versioner (1)
  1. 2016-05-08 2016-05-08 -
Uppladdad den

8 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Kidney Diseases NCT02370069

Engelsk

Eligibility Chronic Kidney Diseases NCT02370069

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females of 18 years of age or older at the time of the vaccination
Beskrivning

Age | Vaccination | Time

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0042196
UMLS CUI [3]
C0040223
severe chronic kidney disease (stage 4 and 5)
Beskrivning

Chronic kidney disease stage 4 | Chronic kidney disease stage 5

Datatyp

boolean

Alias
UMLS CUI [1]
C2317473
UMLS CUI [2]
C2316810
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
immunization with ppv23 within the last year
Beskrivning

Immunization 23-valent pneumococcal capsular polysaccharide vaccine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020971
UMLS CUI [1,2]
C0961101
any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (hiv) infection, haematological malignancy, or a congenital immunodeficiency
Beskrivning

Immunologic Deficiency Syndromes | HIV Infections | Hematologic Neoplasms | Immunodeficiency congenital

Datatyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0376545
UMLS CUI [4]
C0853602
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Beskrivning

Hypersensitivity Probably Exacerbated Due to Vaccine Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0750492
UMLS CUI [1,3]
C1444749
UMLS CUI [1,4]
C0678226
UMLS CUI [1,5]
C0042210
UMLS CUI [1,6]
C1524073
history of allergic disease likely to be stimulated by the vaccination
Beskrivning

Hypersensitivity Probably Stimulated Due to Vaccination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0750492
UMLS CUI [1,3]
C1948023
UMLS CUI [1,4]
C0678226
UMLS CUI [1,5]
C0042196
history or records of immunosuppressive therapy (with the exception of topical corticosteroids) for more than 14 days and within 6 months of vaccination
Beskrivning

History of immunosuppressive therapy | topical steroids | Vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0455630
UMLS CUI [2]
C2064827
UMLS CUI [3]
C0042196
history or evidence of administration of immunoglobulins and/or any blood products during the study period or within the three months preceding the study vaccine
Beskrivning

Administration Immunoglobulins | Administration Blood product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0021027
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C0456388
use of any other investigational or non-registered drug or vaccine during the study period or within 30 days preceding the study vaccine
Beskrivning

Investigational New Drugs Other | Vaccines Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0205394
administration of a vaccine during the period starting one month before the dose of vaccine and ending one month after
Beskrivning

Administration Vaccines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0042210
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Chronic Kidney Diseases NCT02370069

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Vaccination | Time
Item
males and females of 18 years of age or older at the time of the vaccination
boolean
C0001779 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
Chronic kidney disease stage 4 | Chronic kidney disease stage 5
Item
severe chronic kidney disease (stage 4 and 5)
boolean
C2317473 (UMLS CUI [1])
C2316810 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Immunization 23-valent pneumococcal capsular polysaccharide vaccine
Item
immunization with ppv23 within the last year
boolean
C0020971 (UMLS CUI [1,1])
C0961101 (UMLS CUI [1,2])
Immunologic Deficiency Syndromes | HIV Infections | Hematologic Neoplasms | Immunodeficiency congenital
Item
any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (hiv) infection, haematological malignancy, or a congenital immunodeficiency
boolean
C0021051 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0376545 (UMLS CUI [3])
C0853602 (UMLS CUI [4])
Hypersensitivity Probably Exacerbated Due to Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine
boolean
C0020517 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C1444749 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,4])
C0042210 (UMLS CUI [1,5])
C1524073 (UMLS CUI [1,6])
Hypersensitivity Probably Stimulated Due to Vaccination
Item
history of allergic disease likely to be stimulated by the vaccination
boolean
C0020517 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C1948023 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
History of immunosuppressive therapy | topical steroids | Vaccination
Item
history or records of immunosuppressive therapy (with the exception of topical corticosteroids) for more than 14 days and within 6 months of vaccination
boolean
C0455630 (UMLS CUI [1])
C2064827 (UMLS CUI [2])
C0042196 (UMLS CUI [3])
Administration Immunoglobulins | Administration Blood product
Item
history or evidence of administration of immunoglobulins and/or any blood products during the study period or within the three months preceding the study vaccine
boolean
C1533734 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1533734 (UMLS CUI [2,1])
C0456388 (UMLS CUI [2,2])
Investigational New Drugs Other | Vaccines Other
Item
use of any other investigational or non-registered drug or vaccine during the study period or within 30 days preceding the study vaccine
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Administration Vaccines
Item
administration of a vaccine during the period starting one month before the dose of vaccine and ending one month after
boolean
C1533734 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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