ID

14918

Description

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

Lien

https://clinicaltrials.gov/show/NCT02370069

Mots-clés

Versions (1)
  1. 08/05/2016 08/05/2016 -
Téléchargé le

8 mai 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Chronic Kidney Diseases NCT02370069

Anglais

Eligibility Chronic Kidney Diseases NCT02370069

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age | Vaccination | Time

Type de données

boolean

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

Chronic kidney disease stage 4 | Chronic kidney disease stage 5

Type de données

boolean

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

Exclusion Criteria

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

Immunization 23-valent pneumococcal capsular polysaccharide vaccine

Type de données

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
Description

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

Type de données

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
Description

Hypersensitivity Probably Exacerbated Due to Vaccine Component

Type de données

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
Description

Hypersensitivity Probably Stimulated Due to Vaccination

Type de données

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
Description

History of immunosuppressive therapy | topical steroids | Vaccination

Type de données

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
Description

Administration Immunoglobulins | Administration Blood product

Type de données

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
Description

Investigational New Drugs Other | Vaccines Other

Type de données

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
Description

Administration Vaccines

Type de données

boolean

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

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Chronic Kidney Diseases NCT02370069

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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