ID

15754

Description

APOS Therapy for Osteoarthritis of the Knee: a Randomized Controlled Trial BIOTOK; ODM derived from: https://clinicaltrials.gov/show/NCT02363712

Link

https://clinicaltrials.gov/show/NCT02363712

Keywords

Versions (1)
  1. 6/11/16 6/11/16 -
Uploaded on

June 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT02363712

English

Eligibility Osteoarthritis, Knee NCT02363712

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or non-pregnant women
Description

Gender | Not pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232973
aged <= 40
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
outpatient setting
Description

Outpatient setting

Data type

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0542559
acr clinical criteria for oa of the knee
Description

Osteoarthritis, Knee | American College of Rheumatology Improvement Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2]
C3273747
radiologically confirmed symptomatic uni- or bilateral oa of the knee for at least 6 months
Description

Unilateral primary osteoarthritis of knee Symptomatic | Bilateral primary osteoarthritis of knee Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C2893932
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C2893930
UMLS CUI [2,2]
C0231220
radiological criteria: x-rays showing tibiofemoral knee osteoarthritis defined as at least kellgren and lawrence grade 2
Description

criteria Radiologic | roentgenographic | Osteoarthritis, Knee Tibiofemoral joint | Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205483
UMLS CUI [2]
C0034571
UMLS CUI [3,1]
C0409959
UMLS CUI [3,2]
C0022745
UMLS CUI [4]
C3177117
at least moderate pain on the womac pain scale (>3 on a standardized scale range from a minimum of 0 to a maximum of 10)
Description

Moderate pain | Western Ontario and McMaster Universities osteoarthritis index

Data type

boolean

Alias
UMLS CUI [1]
C0278139
UMLS CUI [2]
C3472647
must understand german
Description

Comprehension German language

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0017477
informed consent documented by participant signature
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
aged > 40
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
history of an inflammatory rheumatic disease
Description

Rheumatic disease inflammatory

Data type

boolean

Alias
UMLS CUI [1,1]
C0035435
UMLS CUI [1,2]
C0333348
non-knee musculoskeletal pain as or more severe than the knee pain
Description

Musculoskeletal Pain | Knee pain

Data type

boolean

Alias
UMLS CUI [1]
C0026858
UMLS CUI [2]
C0231749
glucocorticoid injections in the knees in the previous three month
Description

Glucocorticoids Injection Knee

Data type

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C1828121
UMLS CUI [1,3]
C0022742
previous osteotomy
Description

Osteotomy Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0029468
UMLS CUI [1,2]
C0205156
unilateral hemiprosthesis
Description

Prosthesis Hemi Unilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0175649
UMLS CUI [1,2]
C1285521
UMLS CUI [1,3]
C0205092
unilateral total joint replacement
Description

Replacement of total knee joint Unilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C2316964
UMLS CUI [1,2]
C0205092
being treated for cancer
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
participation in another clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Osteoarthritis, Knee NCT02363712

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Not pregnant
Item
men or non-pregnant women
boolean
C0079399 (UMLS CUI [1])
C0232973 (UMLS CUI [2])
Age
Item
aged <= 40
boolean
C0001779 (UMLS CUI [1])
Outpatient setting
Item
outpatient setting
boolean
C0029921 (UMLS CUI [1,1])
C0542559 (UMLS CUI [1,2])
Osteoarthritis, Knee | American College of Rheumatology Improvement Criteria
Item
acr clinical criteria for oa of the knee
boolean
C0409959 (UMLS CUI [1])
C3273747 (UMLS CUI [2])
Unilateral primary osteoarthritis of knee Symptomatic | Bilateral primary osteoarthritis of knee Symptomatic
Item
radiologically confirmed symptomatic uni- or bilateral oa of the knee for at least 6 months
boolean
C2893932 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2893930 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
criteria Radiologic | roentgenographic | Osteoarthritis, Knee Tibiofemoral joint | Kellgren-Lawrence score
Item
radiological criteria: x-rays showing tibiofemoral knee osteoarthritis defined as at least kellgren and lawrence grade 2
boolean
C0243161 (UMLS CUI [1,1])
C0205483 (UMLS CUI [1,2])
C0034571 (UMLS CUI [2])
C0409959 (UMLS CUI [3,1])
C0022745 (UMLS CUI [3,2])
C3177117 (UMLS CUI [4])
Moderate pain | Western Ontario and McMaster Universities osteoarthritis index
Item
at least moderate pain on the womac pain scale (>3 on a standardized scale range from a minimum of 0 to a maximum of 10)
boolean
C0278139 (UMLS CUI [1])
C3472647 (UMLS CUI [2])
Comprehension German language
Item
must understand german
boolean
C0162340 (UMLS CUI [1,1])
C0017477 (UMLS CUI [1,2])
Informed Consent
Item
informed consent documented by participant signature
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Age
Item
aged > 40
boolean
C0001779 (UMLS CUI [1])
Rheumatic disease inflammatory
Item
history of an inflammatory rheumatic disease
boolean
C0035435 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
Musculoskeletal Pain | Knee pain
Item
non-knee musculoskeletal pain as or more severe than the knee pain
boolean
C0026858 (UMLS CUI [1])
C0231749 (UMLS CUI [2])
Glucocorticoids Injection Knee
Item
glucocorticoid injections in the knees in the previous three month
boolean
C0017710 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
Osteotomy Previous
Item
previous osteotomy
boolean
C0029468 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Prosthesis Hemi Unilateral
Item
unilateral hemiprosthesis
boolean
C0175649 (UMLS CUI [1,1])
C1285521 (UMLS CUI [1,2])
C0205092 (UMLS CUI [1,3])
Replacement of total knee joint Unilateral
Item
unilateral total joint replacement
boolean
C2316964 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
cancer treatment
Item
being treated for cancer
boolean
C0920425 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in another clinical trial
boolean
C2348568 (UMLS CUI [1])
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