Gender
Item
1. a female is eligible if she is of:
boolean
C0079399 (UMLS CUI [1])
Childbearing Potential Absent | Postmenopausal state Duration
Item
non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods
Item
child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Pregnancy test negative
Item
pregnancy test result of negative at screening
boolean
C0427780 (UMLS CUI [1])
Primary osteoarthritis of knee | Medial compartment of knee femorotibial
Item
2. primary knee oa(osteoarthritis) on medial femorotibial compartment based on acr(american college rheumatology) criteria.
boolean
C2893931 (UMLS CUI [1])
C0447799 (UMLS CUI [2,1])
C0447795 (UMLS CUI [2,2])
Knee pain | Age | Morning stiffness Duration | Crepitus Motion | Osteophytes Motion
Item
acr criteria : with knee pain and satisfied at least 1 of 3 (① age > 50 years, morning stiffness < 30 minute, ③ presence of crepitus and osteophytes on motion)
boolean
C0231749 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0457086 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0231592 (UMLS CUI [4,1])
C0026597 (UMLS CUI [4,2])
C1956089 (UMLS CUI [5,1])
C0026597 (UMLS CUI [5,2])
Informed Consent
Item
3. appropriately signed and dated informed consent has been obtained
boolean
C0021430 (UMLS CUI [1])
Rheumatoid Arthritis | Arthritis
Item
1. rheumatoid arthritis or inflammatory arthritis.
boolean
C0003873 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
Total knee replacement Bilateral | Total knee replacement Bilateral Planned
Item
2. bilateral total knee replacement already treated, or planning for the procedure.
boolean
C0086511 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0086511 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Knee prosthesis Implanted | Knee prosthesis Planned
Item
3. knee prosthesis already implanted, or foreseen within the next year.
boolean
C0022748 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C0022748 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Osteoarthritis of hip
Item
4. clinically significant hip osteoarthritis.
boolean
C0029410 (UMLS CUI [1])
Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
5. severe renal insufficiency defined as creatinine clearance < 30ml/mln(cockcroft formula).
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
Lung disease | Liver disease | Kidney Disease | Heart Disease | Glycosuria | Diabetes Mellitus | Asthma | Disease Clinical Significance
Item
6. clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( glycosuria(diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.).
boolean
C0024115 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0017979 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
C0004096 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C2826293 (UMLS CUI [8,2])
Medical contraindication MRI | Overweight | Lower Extremity Diameter | Inappropriate Knee Antenna | Artificial cardiac pacemaker | Metallic implant | Clips | Insulin pump | Other Coding | Hearing Aids | Essential Tremor | Claustrophobia
Item
7. mri contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with mri procedure or if known to be unsafe for mri), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc,.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0497406 (UMLS CUI [2])
C0023216 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C1548788 (UMLS CUI [4,1])
C0022742 (UMLS CUI [4,2])
C1706818 (UMLS CUI [4,3])
C0030163 (UMLS CUI [5])
C3693688 (UMLS CUI [6])
C0175722 (UMLS CUI [7])
C1140609 (UMLS CUI [8])
C3846158 (UMLS CUI [9])
C0018768 (UMLS CUI [10])
C0270736 (UMLS CUI [11])
C0008909 (UMLS CUI [12])
Allergic Reaction Investigational New Drugs
Item
8. allergic reaction to clinical trial medication.
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Investigational New Drugs Other
Item
9. other clinical trial drugs during the 1 month prior to the screening visit.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])