ID

31278

Beschreibung

Efficacy Study of "Go On" in Magnetic Resonance Imaging (MRI) Improvement in Osteoarthritis (OA) Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00750724

Link

https://clinicaltrials.gov/show/NCT00750724

Stichworte

Versionen (2)
  1. 07.08.18 07.08.18 -
  2. 07.08.18 07.08.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. August 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Osteoarthritis NCT00750724

Englisch

Eligibility Osteoarthritis NCT00750724

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
ambulatory non pregnant females and males 40-<80 years of age.
Beschreibung

Outpatients | Gender | Pregnancy Absent | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0001779
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.
Beschreibung

Analgesics Withdrawn | Dietary Supplements Withdrawn | Symptom Relief Osteoarthritis of the hand

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0424092
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0424092
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0564405
UMLS CUI [3,3]
C0263746
pain at or below 40 mm on a 100 mm vas in the index knee joints.
Beschreibung

Index Knee joint pain Visual Analog Pain Scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0231749
UMLS CUI [1,3]
C0042815
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.
Beschreibung

Osteoarthritis Knee joint | Idiopathic osteoarthritis Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0022745
UMLS CUI [2,1]
C0409952
UMLS CUI [2,2]
C0449238
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.
Beschreibung

Knee Osteoarthritis Kellgren-Lawrence score Radiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3177117
UMLS CUI [1,3]
C0034571
subject has no any contraindication for mri
Beschreibung

Medical contraindication Absent MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024485
subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment.
Beschreibung

Comprehension Pain | Comprehension Evaluation Arthritis | Comprehension Outcome Assessment (Health Care) | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0030193
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C0003864
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C0085565
UMLS CUI [4]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with history of hypersensitivity to hyaluronate.
Beschreibung

Hypersensitivity Hyaluronate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0178695
subjects with skin lesion at the knee joint.
Beschreibung

Skin lesion Knee joint

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0022745
a history of knee surgery within 6 months prior to screening v0.
Beschreibung

Operative procedure on knee

Datentyp

boolean

Alias
UMLS CUI [1]
C0187769
significant prior injury to the knee joint within 12 months prior to screening v0.
Beschreibung

Injury Knee joint

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3263722
UMLS CUI [1,2]
C0022745
disease of the spine or other lower extremity joints of sufficient degree to affect the knee joint.
Beschreibung

Spinal Disease Affecting Knee joint | Disease Joint of lower extremity Affecting Knee joint

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037933
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0022745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0584731
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0022745
treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
Beschreibung

Pharmaceutical Preparations Affecting Bone metabolism | Pharmaceutical Preparations Affecting Cartilage metabolism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596204
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0596276
chronic systematic corticosteroids
Beschreibung

Adrenal Cortex Hormones systematic chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0220922
UMLS CUI [1,3]
C0205191
diacerin or glucosamine treatment within the last 12 months.
Beschreibung

Diacetylrhein | Glucosamine

Datentyp

boolean

Alias
UMLS CUI [1]
C0057678
UMLS CUI [2]
C0017718
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Ähnliche Modelle

Eligibility Osteoarthritis NCT00750724

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