ID

40724

Beschreibung

Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01293955

Link

https://clinicaltrials.gov/show/NCT01293955

Stichworte

Versionen (1)
  1. 04.05.20 04.05.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Mai 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01293955

Englisch

Eligibility Knee Osteoarthritis NCT01293955

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. a female is eligible if she is of:
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
Beschreibung

Childbearing Potential Absent | Postmenopausal state Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0449238
child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
pregnancy test result of negative at screening
Beschreibung

Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
2. primary knee oa(osteoarthritis) on medial femorotibial compartment based on acr(american college rheumatology) criteria.
Beschreibung

Primary osteoarthritis of knee | Medial compartment of knee femorotibial

Datentyp

boolean

Alias
UMLS CUI [1]
C2893931
UMLS CUI [2,1]
C0447799
UMLS CUI [2,2]
C0447795
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)
Beschreibung

Knee pain | Age | Morning stiffness Duration | Crepitus Motion | Osteophytes Motion

Datentyp

boolean

Alias
UMLS CUI [1]
C0231749
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0457086
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C0231592
UMLS CUI [4,2]
C0026597
UMLS CUI [5,1]
C1956089
UMLS CUI [5,2]
C0026597
3. appropriately signed and dated informed consent has been obtained
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. rheumatoid arthritis or inflammatory arthritis.
Beschreibung

Rheumatoid Arthritis | Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0003864
2. bilateral total knee replacement already treated, or planning for the procedure.
Beschreibung

Total knee replacement Bilateral | Total knee replacement Bilateral Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C0238767
UMLS CUI [2,1]
C0086511
UMLS CUI [2,2]
C0238767
UMLS CUI [2,3]
C1301732
3. knee prosthesis already implanted, or foreseen within the next year.
Beschreibung

Knee prosthesis Implanted | Knee prosthesis Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022748
UMLS CUI [1,2]
C0021102
UMLS CUI [2,1]
C0022748
UMLS CUI [2,2]
C1301732
4. clinically significant hip osteoarthritis.
Beschreibung

Osteoarthritis of hip

Datentyp

boolean

Alias
UMLS CUI [1]
C0029410
5. severe renal insufficiency defined as creatinine clearance < 30ml/mln(cockcroft formula).
Beschreibung

Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2711451
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.).
Beschreibung

Lung disease | Liver disease | Kidney Disease | Heart Disease | Glycosuria | Diabetes Mellitus | Asthma | Disease Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0017979
UMLS CUI [6]
C0011849
UMLS CUI [7]
C0004096
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C2826293
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,.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0497406
UMLS CUI [3,1]
C0023216
UMLS CUI [3,2]
C1301886
UMLS CUI [4,1]
C1548788
UMLS CUI [4,2]
C0022742
UMLS CUI [4,3]
C1706818
UMLS CUI [5]
C0030163
UMLS CUI [6]
C3693688
UMLS CUI [7]
C0175722
UMLS CUI [8]
C1140609
UMLS CUI [9]
C3846158
UMLS CUI [10]
C0018768
UMLS CUI [11]
C0270736
UMLS CUI [12]
C0008909
8. allergic reaction to clinical trial medication.
Beschreibung

Allergic Reaction Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230
9. other clinical trial drugs during the 1 month prior to the screening visit.
Beschreibung

Investigational New Drugs Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
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Ähnliche Modelle

Eligibility Knee Osteoarthritis NCT01293955

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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