ID

19235

Beschrijving

Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00649922

Link

https://clinicaltrials.gov/show/NCT00649922

Trefwoorden

Versies (1)
  1. 14-12-16 14-12-16 -
Geüploaded op

14 december 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00649922

Engels

Eligibility Rheumatoid Arthritis NCT00649922

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male/females at least 20 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
Beschrijving

Postmenopausal state | Female Sterilization | Gender Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
females have a negative pregnancy test at screening.
Beschrijving

Gender Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
diagnosis of ra and met acr criteria.
Beschrijving

Rheumatoid Arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0003873
must discontinue any tnf at least 2 months prior to baseline.
Beschrijving

tumor necrosis factor therapy Discontinue

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279936
UMLS CUI [1,2]
C1444662
in condition of general good health.
Beschrijving

General health good

Datatype

boolean

Alias
UMLS CUI [1]
C1277245
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with listeria or tb; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
Beschrijving

Drug Allergy Significant | Substance Use Disorders Clinical Significance | Listeriosis | Tuberculosis | Lymphoma | leukemia | Anemia, Sickle Cell | Splenectomy | Malignant Neoplasms | Basal cell carcinoma Treated Successful | Squamous cell carcinoma of skin Treated Successful | Carcinoma in situ of uterine cervix Localized Treated Successful

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C2826293
UMLS CUI [3]
C0023860
UMLS CUI [4]
C0041296
UMLS CUI [5]
C0024299
UMLS CUI [6]
C0023418
UMLS CUI [7]
C0002895
UMLS CUI [8]
C0037995
UMLS CUI [9]
C0006826
UMLS CUI [10,1]
C0007117
UMLS CUI [10,2]
C1522326
UMLS CUI [10,3]
C1272703
UMLS CUI [11,1]
C0553723
UMLS CUI [11,2]
C1522326
UMLS CUI [11,3]
C1272703
UMLS CUI [12,1]
C0851140
UMLS CUI [12,2]
C0392752
UMLS CUI [12,3]
C1522326
UMLS CUI [12,4]
C1272703
history of current acute inflammatory joint disease.
Beschrijving

inflammatory joint disease

Datatype

boolean

Alias
UMLS CUI [1]
C0683381
use of tamiflu or symmetrel within 3 months of study drug administration.
Beschrijving

Tamiflu | Symmetrel

Datatype

boolean

Alias
UMLS CUI [1]
C0876173
UMLS CUI [2]
C0026055
recent (3 month) history of influenza or pneumococcal bacterial infection.
Beschrijving

Influenza | Pneumococcal Infections

Datatype

boolean

Alias
UMLS CUI [1]
C0021400
UMLS CUI [2]
C0032269
known positive human immunodeficiency virus (hiv) status.
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
positive hepatitis b or hepatitis c virus.
Beschrijving

Hepatitis B virus test positive | Hepatitis C virus test positive

Datatype

boolean

Alias
UMLS CUI [1]
C2748184
UMLS CUI [2]
C2748185
positive ppd >5 mm.
Beschrijving

Mantoux: positive

Datatype

boolean

Alias
UMLS CUI [1]
C0032739
chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.
Beschrijving

Plain chest X-ray Calcified granuloma | Plain chest X-ray Pleural scarring | Plain chest X-ray Abnormality Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0333404
UMLS CUI [2,1]
C0039985
UMLS CUI [2,2]
C0577703
UMLS CUI [3,1]
C0039985
UMLS CUI [3,2]
C1704258
UMLS CUI [3,3]
C0750502
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Similar models

Eligibility Rheumatoid Arthritis NCT00649922

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male/females at least 20 years of age.
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods
Item
females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Gender Pregnancy test negative
Item
females have a negative pregnancy test at screening.
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Rheumatoid Arthritis
Item
diagnosis of ra and met acr criteria.
boolean
C0003873 (UMLS CUI [1])
tumor necrosis factor therapy Discontinue
Item
must discontinue any tnf at least 2 months prior to baseline.
boolean
C0279936 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
General health good
Item
in condition of general good health.
boolean
C1277245 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Drug Allergy Significant | Substance Use Disorders Clinical Significance | Listeriosis | Tuberculosis | Lymphoma | leukemia | Anemia, Sickle Cell | Splenectomy | Malignant Neoplasms | Basal cell carcinoma Treated Successful | Squamous cell carcinoma of skin Treated Successful | Carcinoma in situ of uterine cervix Localized Treated Successful
Item
history of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with listeria or tb; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
boolean
C0013182 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0023860 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
C0024299 (UMLS CUI [5])
C0023418 (UMLS CUI [6])
C0002895 (UMLS CUI [7])
C0037995 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C0007117 (UMLS CUI [10,1])
C1522326 (UMLS CUI [10,2])
C1272703 (UMLS CUI [10,3])
C0553723 (UMLS CUI [11,1])
C1522326 (UMLS CUI [11,2])
C1272703 (UMLS CUI [11,3])
C0851140 (UMLS CUI [12,1])
C0392752 (UMLS CUI [12,2])
C1522326 (UMLS CUI [12,3])
C1272703 (UMLS CUI [12,4])
inflammatory joint disease
Item
history of current acute inflammatory joint disease.
boolean
C0683381 (UMLS CUI [1])
Tamiflu | Symmetrel
Item
use of tamiflu or symmetrel within 3 months of study drug administration.
boolean
C0876173 (UMLS CUI [1])
C0026055 (UMLS CUI [2])
Influenza | Pneumococcal Infections
Item
recent (3 month) history of influenza or pneumococcal bacterial infection.
boolean
C0021400 (UMLS CUI [1])
C0032269 (UMLS CUI [2])
HIV Seropositivity
Item
known positive human immunodeficiency virus (hiv) status.
boolean
C0019699 (UMLS CUI [1])
Hepatitis B virus test positive | Hepatitis C virus test positive
Item
positive hepatitis b or hepatitis c virus.
boolean
C2748184 (UMLS CUI [1])
C2748185 (UMLS CUI [2])
Mantoux: positive
Item
positive ppd >5 mm.
boolean
C0032739 (UMLS CUI [1])
Plain chest X-ray Calcified granuloma | Plain chest X-ray Pleural scarring | Plain chest X-ray Abnormality Significant
Item
chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.
boolean
C0039985 (UMLS CUI [1,1])
C0333404 (UMLS CUI [1,2])
C0039985 (UMLS CUI [2,1])
C0577703 (UMLS CUI [2,2])
C0039985 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
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