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])
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])