Eligibility Osteoarthritis NCT00365586

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StudyEvent: Eligibility
1. Eligibility Osteoarthritis NCT00365586

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

males or females 18 years of age or older

boolean

C0001779 (UMLS CUI [1])

Unilateral primary osteoarthritis of knee | Bilateral primary osteoarthritis of knee

Item

diagnosis of osteoarthritis of the knee (unilateral or bilateral)

boolean

C2893932 (UMLS CUI [1])
C2893930 (UMLS CUI [2])

Pain criteria Fulfill

Item

meet pain entry criteria

boolean

C0030193 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])

Analgesics Discontinue Willing | Analgesics OTC - Over The Counter | Analgesics Study Protocol

Item

willing to discontinue use of all analgesic medications (including over-the-counter [otc] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes.

boolean

C0002771 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0002771 (UMLS CUI [2,1])
C2709201 (UMLS CUI [2,2])
C0002771 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Urine pregnancy test positive | Pregnancy | Breast Feeding

Item

positive urine pregnancy test, pregnant or lactating.

boolean

C0430059 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])

Fibromyalgia | Arthritis | Gout | Pseudogout | Paget's Disease

Item

have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or paget's disease

boolean

C0016053 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C0033802 (UMLS CUI [4])
C1368019 (UMLS CUI [5])

Arthropathy | Knee Replacement Arthroplasty Knee Involved

Item

have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee

boolean

C0022408 (UMLS CUI [1])
C0086511 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])

Adrenal Cortex Hormones Injection | Hyaluronic Acid

Item

have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit

boolean

C0001617 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0020196 (UMLS CUI [2])

Physical Examination | Finding Inconsistent Clinical Trial participation | Finding Inconsistent Investigational New Drug Use of

Item

have a history or physical examination finding that is incompatible with safe participation in the study or study product use

boolean

C0031809 (UMLS CUI [1])
C0243095 (UMLS CUI [2,1])
C0442809 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0679823 (UMLS CUI [2,4])
C0243095 (UMLS CUI [3,1])
C0442809 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C1524063 (UMLS CUI [3,4])

Medical contraindication Pharmaceutical Preparations | Medical contraindication Substance | Investigational New Drugs | Drug Interactions

Item

are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.

boolean

C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0439861 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3])
C0687133 (UMLS CUI [4])

Renal Insufficiency | Hepatic impairment

Item

have significant renal or hepatic impairment

boolean

C1565489 (UMLS CUI [1])
C0948807 (UMLS CUI [2])

taking medication to help sleep Dose Unstable

Item

are taking a sleep medication at a dose that has not been stable for at least 3 months

boolean

C2054158 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])

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Eligibility Osteoarthritis NCT00365586