Eligibility Osteoarthritis of the Knee NCT00755482

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StudyEvent: Eligibility
1. Eligibility Osteoarthritis of the Knee NCT00755482

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

age, gender

Item

subjects aged 35 to 75, male or female

boolean

C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])

symptomatic moderate to severe knee osteoarthritis

Item

subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee according to the modified criteria of the american college of rheumatology 17,18

boolean

C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1299393 (UMLS CUI [1,3])

osteoarthritis of the knee; Questionnaires; Symptoms | Osteoarthritis, Knee; Prior diagnosis

Item

subjects who present with osteoarthritis of the knee as judged by symptoms and disabilities detectable through published, validated questionnaires or previous diagnosis by a physician

boolean

C0409959 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0409959 (UMLS CUI [2,1])
C0332132 (UMLS CUI [2,2])

symptomatic with daily or near daily pain and stiffness from osteoarthritis

Item

subjects who are symptomatic with daily or near daily pain and stiffness from osteoarthritis

boolean

C0231220 (UMLS CUI [1,1])
C3841784 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])

nsaid

Item

subjects who are taking non-steroidal anti-inflammatory drugs (nsaids) prior to study enrollment

boolean

C0003211 (UMLS CUI [1])

acetaminophen, stop nsaid

Item

subjects who are willing to stop nsaids and use acetaminophen for pain management during the trial

boolean

C0000970 (UMLS CUI [1])
C0850893 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])

womac

Item

subjects with screening womac osteoarthritis index total score (transformed score) of not more than 75

boolean

C3472647 (UMLS CUI [1])

ability to comprehend questionnaires

Item

subjects with ability to comprehend and complete the questionnaires and forms

boolean

C1273101 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])

clinical evaluation, every four weeks

Item

subjects whose schedules permit clinical evaluations every four weeks

boolean

C1261322 (UMLS CUI [1,1])
C1275555 (UMLS CUI [1,2])

stop calcium supplements, restricted consumption of calcium

Item

subjects who are willing to stop taking calcium supplements, if any and to restrict consumption of high calcium food to 600mg (two dairy servings) per day

boolean

C3540037 (UMLS CUI [1,1])
C0850893 (UMLS CUI [1,2])
C0425422 (UMLS CUI [2,1])
C0489458 (UMLS CUI [2,2])

compliance behavior

Item

subjects with a high probability of compliance with study procedures and test article consumption

boolean

C1321605 (UMLS CUI [1])

protocol compliance

Item

subjects willing and able to follow protocol guidelines and schedules and complete diaries

boolean

C0525058 (UMLS CUI [1])

compliance behavior, study subject participation status

Item

subjects who are likely to abstain from taking unathorized supplements or participating in any other clinical trial or experimental treatment during this trial

boolean

C1321605 (UMLS CUI [1])
C2348568 (UMLS CUI [2])

gastrointestinal digestion and absorption

Item

subjects with normal gastrointestinal digestion and absorption

boolean

C0678869 (UMLS CUI [1,1])
C3714657 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

inflammatory arthritis, gout, pseudogout, paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or hiv infection

Item

subjects who have a history of inflammatory arthritis, gout, pseudogout, paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or hiv infection

boolean

C1562028 (UMLS CUI [1])
C0018099 (UMLS CUI [2])
C0033802 (UMLS CUI [3])
C1368019 (UMLS CUI [4])
C0014544 (UMLS CUI [5])
C0011854 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0006826 (UMLS CUI [10])
C0019682 (UMLS CUI [11])
C0007222 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])

subjects who are non-ambulatory or bedridden due to osteoarthritis

Item

subjects who are non-ambulatory or bedridden due to osteoarthritis

boolean

C0560046 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
C0741453 (UMLS CUI [2,1])
C0409959 (UMLS CUI [2,2])

dependent on prescription drugs to control pain

Item

subjects who are dependent on prescription drugs to control pain

boolean

C2128645 (UMLS CUI [1])

study subject participation status

Item

subjects on any other clinical trial or experimental treatment in the past 3 months

boolean

C2348568 (UMLS CUI [1])

pregnancy, breast feeding, childbearing potential

Item

subjects who are pregnant, lactating or at risk of becoming pregnant

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])

intramuscular corticosteroid injection, systemic corticosteroid administration, intra-articular corticosteroid injection, intra-articular hyaluronic acid injection

Item

subjects who have received : intramuscular corticosteroid injection or systemic corticosteroid administration within 4 weeks prior to study enrollment, intra-articular corticosteroid injection within 2 months prior to study enrollment or intra-articular hyaluronic acid injection within 4 months prior to study enrollment.

boolean

C0585373 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
C2064783 (UMLS CUI [3])
C0021488 (UMLS CUI [4,1])
C0020196 (UMLS CUI [4,2])

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Eligibility Osteoarthritis of the Knee NCT00755482