Informed Consent | Protocol Compliance
Item
subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Outpatients | Gender | Pregnancy Absent | Age
Item
ambulatory non pregnant females and males 40-<80 years of age.
boolean
C0029921 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Analgesics Withdrawn | Dietary Supplements Withdrawn | Symptom Relief Osteoarthritis of the hand
Item
subjects who withdraw pain medication or nutritional supplements for symptom relief for oa hand for a total of at least 30 days before screening visit 0.
boolean
C0002771 (UMLS CUI [1,1])
C0424092 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2,1])
C0424092 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0564405 (UMLS CUI [3,2])
C0263746 (UMLS CUI [3,3])
Index Knee joint pain Visual Analog Pain Scale
Item
pain at or below 40 mm on a 100 mm vas in the index knee joints.
boolean
C2986546 (UMLS CUI [1,1])
C0231749 (UMLS CUI [1,2])
C0042815 (UMLS CUI [1,3])
Osteoarthritis Knee joint | Idiopathic osteoarthritis Duration
Item
a documented diagnosis of oa of the knee joint, or meeting american college of rheumatology (acr) clinical criteria for classification of idiopathic (primary) oa for at least 6 months prior to screening.
boolean
C0029408 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
C0409952 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Knee Osteoarthritis Kellgren-Lawrence score Radiography
Item
subject has been documented radiographic evidence of oa of the knees from the screening visit radiograph of grade 2 or 3 according to kellgren and lawrence radiographic grading.
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
Medical contraindication Absent MRI
Item
subject has no any contraindication for mri
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Comprehension Pain | Comprehension Evaluation Arthritis | Comprehension Outcome Assessment (Health Care) | Protocol Compliance
Item
subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment.
boolean
C0162340 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0003864 (UMLS CUI [2,3])
C0162340 (UMLS CUI [3,1])
C0085565 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4])
Hypersensitivity Hyaluronate
Item
subjects with history of hypersensitivity to hyaluronate.
boolean
C0020517 (UMLS CUI [1,1])
C0178695 (UMLS CUI [1,2])
Skin lesion Knee joint
Item
subjects with skin lesion at the knee joint.
boolean
C0037284 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
Operative procedure on knee
Item
a history of knee surgery within 6 months prior to screening v0.
boolean
C0187769 (UMLS CUI [1])
Injury Knee joint
Item
significant prior injury to the knee joint within 12 months prior to screening v0.
boolean
C3263722 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
Spinal Disease Affecting Knee joint | Disease Joint of lower extremity Affecting Knee joint
Item
disease of the spine or other lower extremity joints of sufficient degree to affect the knee joint.
boolean
C0037933 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0022745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0584731 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0022745 (UMLS CUI [2,4])
Pharmaceutical Preparations Affecting Bone metabolism | Pharmaceutical Preparations Affecting Cartilage metabolism
Item
treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596276 (UMLS CUI [2,3])
Adrenal Cortex Hormones systematic chronic
Item
chronic systematic corticosteroids
boolean
C0001617 (UMLS CUI [1,1])
C0220922 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Diacetylrhein | Glucosamine
Item
diacerin or glucosamine treatment within the last 12 months.
boolean
C0057678 (UMLS CUI [1])
C0017718 (UMLS CUI [2])