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Eligibility Osteoarthritis, Knee NCT00447486

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatient, >= 40 years of age
Description

Age | Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0029921
meets acr clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
Description

Knee Osteoarthritis idiopathic ACR Criteria Classification | Symptoms Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0332240
UMLS CUI [1,3]
C3273747
UMLS CUI [1,4]
C0008902
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0449238
meets ara functional status requirements
Description

Other Coding | Functional Status

Data type

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0598463
meets womac pain subscale score requirements
Description

WOMAC scale

Data type

boolean

Alias
UMLS CUI [1]
C3472647
has taken analgesics for the treatment of their knee oa for at least 4 out of 7 days in each of the 4 weeks preceding screen
Description

Analgesic therapy Knee Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0412784
UMLS CUI [1,2]
C0409959
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any pre-specified clinical/biological/ecg abnormality
Description

Abnormality Clinical Pre-specified | Abnormality biological Pre-specified | ECG abnormality Pre-specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C2826245
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0205460
UMLS CUI [2,3]
C2826245
UMLS CUI [3,1]
C1832603
UMLS CUI [3,2]
C2826245
any pre-specified drug sensitivity
Description

Drug Allergy Pre-specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C2826245
history of peptic ulceration or gi bleeding
Description

Peptic Ulcer | Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017181
use of protocol-specified medications
Description

Pharmaceutical Preparations Protocol Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0205369
secondary cause of knee oa
Description

Cause Secondary Knee Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0409959
lower extremity surgery within 6 months of screening
Description

Surgical procedure on lower extremity

Data type

boolean

Alias
UMLS CUI [1]
C0187763
use of analgesics other than allowed per protocol
Description

Analgesics | Exception Study Protocol allowed

Data type

boolean

Alias
UMLS CUI [1]
C0002771
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0683607
use of corticosteroids or hyaluronan outside of allowed window prior to screening
Description

Adrenal Cortex Hormones | Hyaluronan

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0813622
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Similar models

Eligibility Osteoarthritis, Knee NCT00447486

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Outpatients
Item
male or female outpatient, >= 40 years of age
boolean
C0001779 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Knee Osteoarthritis idiopathic ACR Criteria Classification | Symptoms Duration
Item
meets acr clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
boolean
C0409959 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C3273747 (UMLS CUI [1,3])
C0008902 (UMLS CUI [1,4])
C1457887 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Other Coding | Functional Status
Item
meets ara functional status requirements
boolean
C3846158 (UMLS CUI [1])
C0598463 (UMLS CUI [2])
WOMAC scale
Item
meets womac pain subscale score requirements
boolean
C3472647 (UMLS CUI [1])
Analgesic therapy Knee Osteoarthritis
Item
has taken analgesics for the treatment of their knee oa for at least 4 out of 7 days in each of the 4 weeks preceding screen
boolean
C0412784 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Abnormality Clinical Pre-specified | Abnormality biological Pre-specified | ECG abnormality Pre-specified
Item
any pre-specified clinical/biological/ecg abnormality
boolean
C1704258 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C2826245 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0205460 (UMLS CUI [2,2])
C2826245 (UMLS CUI [2,3])
C1832603 (UMLS CUI [3,1])
C2826245 (UMLS CUI [3,2])
Drug Allergy Pre-specified
Item
any pre-specified drug sensitivity
boolean
C0013182 (UMLS CUI [1,1])
C2826245 (UMLS CUI [1,2])
Peptic Ulcer | Gastrointestinal Hemorrhage
Item
history of peptic ulceration or gi bleeding
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
Pharmaceutical Preparations Protocol Specified
Item
use of protocol-specified medications
boolean
C0013227 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Cause Secondary Knee Osteoarthritis
Item
secondary cause of knee oa
boolean
C0015127 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])
Surgical procedure on lower extremity
Item
lower extremity surgery within 6 months of screening
boolean
C0187763 (UMLS CUI [1])
Analgesics | Exception Study Protocol allowed
Item
use of analgesics other than allowed per protocol
boolean
C0002771 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Adrenal Cortex Hormones | Hyaluronan
Item
use of corticosteroids or hyaluronan outside of allowed window prior to screening
boolean
C0001617 (UMLS CUI [1])
C0813622 (UMLS CUI [2])
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