ID

15953

Description

Anti-TNFα Use During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02242474

Link

https://clinicaltrials.gov/show/NCT02242474

Keywords

Versions (1)
  1. 6/20/16 6/20/16 -
Uploaded on

June 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02242474

English

Eligibility Rheumatoid Arthritis NCT02242474

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
rheumatoid arthritis diagnostic according to the american college rheumatology (acr) 1987 criteria [38]
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
patient treated with anti-tnfα for at least six months
Description

anti-TNF-alpha therapy

Data type

boolean

Alias
UMLS CUI [1]
C0281481
elective unilateral surgery of the foot and ankle
Description

Operative procedure on foot Unilateral elective | Operative procedure on ankle Unilateral elective

Data type

boolean

Alias
UMLS CUI [1,1]
C0188413
UMLS CUI [1,2]
C0205092
UMLS CUI [1,3]
C0439608
UMLS CUI [2,1]
C0188412
UMLS CUI [2,2]
C0205092
UMLS CUI [2,3]
C0439608
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient unable to give informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
surgery on an infected site
Description

Operative Surgical Procedure Site Infected

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0439663
severe distal peripheral vascular disease (no distal pulse)
Description

Peripheral Vascular Disease Distal Severe | Pulse Distal

Data type

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205108
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0391850
UMLS CUI [2,2]
C0205108
medical condition contraindicating surgery
Description

medical condition | Medical contraindication Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C1699700
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0543467
patient treated with biologic dmard other than anti-tnfα
Description

Therapeutic procedure Biologic DMARD | anti-TNF-alpha therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C4055380
UMLS CUI [2]
C0281481
circumstances preventing an adequate postoperative follow-up
Description

Circumstances Preventing Postoperative follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1821459
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C2585426
revision surgery
Description

Surgical revision

Data type

boolean

Alias
UMLS CUI [1]
C0558347
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Similar models

Eligibility Rheumatoid Arthritis NCT02242474

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis
Item
rheumatoid arthritis diagnostic according to the american college rheumatology (acr) 1987 criteria [38]
boolean
C0003873 (UMLS CUI [1])
anti-TNF-alpha therapy
Item
patient treated with anti-tnfα for at least six months
boolean
C0281481 (UMLS CUI [1])
Operative procedure on foot Unilateral elective | Operative procedure on ankle Unilateral elective
Item
elective unilateral surgery of the foot and ankle
boolean
C0188413 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0439608 (UMLS CUI [1,3])
C0188412 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0439608 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
patient unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Operative Surgical Procedure Site Infected
Item
surgery on an infected site
boolean
C0543467 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0439663 (UMLS CUI [1,3])
Peripheral Vascular Disease Distal Severe | Pulse Distal
Item
severe distal peripheral vascular disease (no distal pulse)
boolean
C0085096 (UMLS CUI [1,1])
C0205108 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0391850 (UMLS CUI [2,1])
C0205108 (UMLS CUI [2,2])
medical condition | Medical contraindication Operative Surgical Procedures
Item
medical condition contraindicating surgery
boolean
C1699700 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Therapeutic procedure Biologic DMARD | anti-TNF-alpha therapy
Item
patient treated with biologic dmard other than anti-tnfα
boolean
C0087111 (UMLS CUI [1,1])
C4055380 (UMLS CUI [1,2])
C0281481 (UMLS CUI [2])
Circumstances Preventing Postoperative follow-up
Item
circumstances preventing an adequate postoperative follow-up
boolean
C1821459 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2585426 (UMLS CUI [1,3])
Surgical revision
Item
revision surgery
boolean
C0558347 (UMLS CUI [1])
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