Eligibility NCT00731289 Osteoarthritis

ODM derived from http://clinicaltrials.gov/show/NCT00731289

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 35 Years to 80 Years
Item
Age 35 Years to 80 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
radiographically verified degenerative osteoarthritis of the knee (grade II or III according to the Kellgren and Lawrence classification)
Item
radiographically verified degenerative osteoarthritis of the knee (grade II or III according to the Kellgren and Lawrence classification)
boolean
C0444708 (UMLS CUI 2011AA)
258106000 (SNOMED CT 2011_0131)
C1711411 (UMLS CUI 2011AA)
C0409959 (UMLS CUI 2011AA)
239873007 (SNOMED CT 2011_0131)
10031165 (MedDRA 14.1)
M17 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1522446 (UMLS CUI 2011AA)
C0450094 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
pain of at least 40 mm on a 100 mm visual analogue scale (VAS) at initial examination
Item
pain of at least 40 mm on a 100 mm visual analogue scale (VAS) at initial examination
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
C0042815 (UMLS CUI 2011AA)
273903006 (SNOMED CT 2011_0131)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
persisting pain for at least 6 months
Item
persisting pain for at least 6 months
boolean
C0205322 (UMLS CUI 2011AA)
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Lequesne-Score of at least 10 points
Item
Lequesne index - knee (assessment scale)
boolean
C0451259 (UMLS CUI 2011AA)
273567003 (SNOMED CT 2011_0131)
good physical and mental status
Item
good physical and mental status
boolean
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C0679834 (UMLS CUI 2011AA)
C0278060 (UMLS CUI 2011AA)
36456004 (SNOMED CT 2011_0131)
MTHU001424 (LOINC Version 232)
MTHU117157 (CTCAE 1105E)
good compliance and agreement to participate in this study
Item
good compliance and agreement to participate in this study
boolean
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
non-degeneratively induced osteoarthritis
Item
non-degeneratively induced osteoarthritis
boolean
C1518422 (UMLS CUI 2011AA)
C0011164 (UMLS CUI 2011AA)
33359002 (SNOMED CT 2011_0131)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0029408 (UMLS CUI 2011AA)
396275006, 225655006 (SNOMED CT 2011_0131)
10031161 (MedDRA 14.1)
M19.9 (ICD-10-CM Version 2010)
715.9 (ICD-9-CM Version 2011)
rheumatoid arthritis
Item
Rheumatoid Arthritis
boolean
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
ligamentous instability or complete resection of the meniscus
Item
ligamentous instability or complete resection of the meniscus
boolean
C1269080 (UMLS CUI 2011AA)
182358004 (SNOMED CT 2011_0131)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0224498 (UMLS CUI 2011AA)
74135004 (SNOMED CT 2011_0131)
Sudeck´s disease
Item
Sudeck's atrophy, Reflex Sympathetic Dystrophy
boolean
C0034931 (UMLS CUI 2011AA)
15743005 (SNOMED CT 2011_0131)
10042442 (MedDRA 14.1)
M89.0 (ICD-10-CM Version 2010)
337.20 (ICD-9-CM Version 2011)
operations of the affected knee within the last three months
Item
operations of the affected knee within the last three months
boolean
C0187769 (UMLS CUI 2011AA)
6240004 (SNOMED CT 2011_0131)
10049548 (MedDRA 14.1)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
varus or valgus deformity of > 15 degrees
Item
varus or valgus deformity of > 15 degrees
boolean
C0544754 (UMLS CUI 2011AA)
127562007 (SNOMED CT 2011_0131)
C0042282 (UMLS CUI 2011AA)
127561000 (SNOMED CT 2011_0131)
C0449286 (UMLS CUI 2011AA)
246173007 (SNOMED CT 2011_0131)
patellofemoral arthritis
Item
patellofemoral arthritis
boolean
C0447801 (UMLS CUI 2011AA)
129160003 (SNOMED CT 2011_0131)
C0003864 (UMLS CUI 2011AA)
3723001 (SNOMED CT 2011_0131)
10003246 (MedDRA 14.1)
MTHU020793 (LOINC Version 232)
M19.90 (ICD-10-CM Version 2010)
716.9 (ICD-9-CM Version 2011)
E12378 (CTCAE 1105E)
intraarticular therapy of the affected joint within the last 6 months with hyaluronan and three months with glucocorticoids
Item
intraarticular therapy of the affected joint within the last 6 months with hyaluronan and three months with glucocorticoids
boolean
C0205528 (UMLS CUI 2011AA)
12130007 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0022417 (UMLS CUI 2011AA)
39352004 (SNOMED CT 2011_0131)
C0020196 (UMLS CUI 2011AA)
38218009 (SNOMED CT 2011_0131)
MTHU003533 (LOINC Version 232)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
severe systemic diseases (tumor, exacerbated diabetes mellitus, hyperthyroidism)
Item
severe systemic diseases (tumor, exacerbated diabetes mellitus, hyperthyroidism)
boolean
C0973444 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1444749 (UMLS CUI 2011AA)
410661009 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0020550 (UMLS CUI 2011AA)
34486009 (SNOMED CT 2011_0131)
10020850 (MedDRA 14.1)
MTHU020782 (LOINC Version 232)
E05.9 (ICD-10-CM Version 2010)
242.9 (ICD-9-CM Version 2011)
E10322 (CTCAE 1105E)
anti-thrombotic medication or regular medication with NSAID/psychiatric pharmaceuticals
Item
anti-thrombotic medication or regular medication with NSAID/psychiatric pharmaceuticals
boolean
C1704311 (UMLS CUI 2011AA)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0204585 (UMLS CUI 2011AA)
302440009 (SNOMED CT 2011_0131)
infectious diseases
Item
Communicable Diseases
boolean
C0009450 (UMLS CUI 2011AA)
40733004 (SNOMED CT 2011_0131)
10021881 (MedDRA 14.1)
MTHU034915 (LOINC Version 232)
136.9 (ICD-9-CM Version 2011)
alcohol abuse
Item
Alcohol abuse
boolean
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
drugs
Item
Drug abuse
boolean
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
psychiatric diseases or suicidal tendencies
Item
psychiatric diseases or suicidal tendencies
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0235196 (UMLS CUI 2011AA)
10042461 (SNOMED CT 2011_0131)
involvement in another study
Item
involvement in another study
boolean
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
non-compliance
Item
Non-compliant
boolean
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
acute hemarthrosis or joint effusion
Item
acute hemarthrosis or joint effusion
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0018924 (UMLS CUI 2011AA)
81808003 (SNOMED CT 2011_0131)
10018829 (MedDRA 14.1)
M25.0 (ICD-10-CM Version 2010)
719.1 (ICD-9-CM Version 2011)
C1253936 (UMLS CUI 2011AA)
387637008 (SNOMED CT 2011_0131)
10023215 (MedDRA 14.1)
M25.4 (ICD-10-CM Version 2010)
719.0 (ICD-9-CM Version 2011)
E12431 (CTCAE 1105E)
allergic predisposition
Item
allergic predisposition
boolean
C0700624 (UMLS CUI 2011AA)
C0012655 (UMLS CUI 2011AA)
76522002 (SNOMED CT 2011_0131)
skin infections or skin diseases around the knee
Item
skin infections or skin diseases around the knee
boolean
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
C0037274 (UMLS CUI 2011AA)
95320005 (SNOMED CT 2011_0131)
10048768, 10040831 (MedDRA 14.1)
MTHU031899 (LOINC Version 232)
C0022742 (UMLS CUI 2011AA)
304679005 (SNOMED CT 2011_0131)
MTHU002687 (LOINC Version 232)

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