ID

40769

Beschrijving

To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection; ODM derived from: https://clinicaltrials.gov/show/NCT01895959

Link

https://clinicaltrials.gov/show/NCT01895959

Trefwoorden

Versies (1)
  1. 10-05-20 10-05-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 mei 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01895959

Engels

Eligibility Knee Osteoarthritis NCT01895959

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 to 80 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
symptomatic knee oa as defined by the american college of rheumatology criteria
Beschrijving

Knee Osteoarthritis Symptomatic ACR Criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C3273747
kellgren-lawrence grade i, ii or iii on prior x-rays (take within 6 months of screening visit)
Beschrijving

X-Ray Computed Tomography Kellgren-Lawrence score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C3177117
knee pain score >40 mm on a 100 mm visual analogue scale for > 15 days in the last month
Beschrijving

Knee pain Visual Analog Pain Scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0042815
nsaids permitted if the dose has been stable for at least one month prior to baseline and stays stable during the study
Beschrijving

NSAIDs Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
have been recommended for euflexxa treatment by physician
Beschrijving

Euflexxa Recommended

Datatype

boolean

Alias
UMLS CUI [1,1]
C1637315
UMLS CUI [1,2]
C0034866
knee effusion based on clinical exam or imaging
Beschrijving

Knee effusion Clinical examination | Knee effusion Imaging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0343166
UMLS CUI [1,2]
C1456356
UMLS CUI [2,1]
C0343166
UMLS CUI [2,2]
C0011923
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindication to mri (pregnancy, metallic fragments in the eyes, vascular clips, pacemakers etc)
Beschrijving

Medical contraindication MRI | Pregnancy | Metal foreign body in eye region | Vascular clip | Pacemakers

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0562528
UMLS CUI [4]
C0179992
UMLS CUI [5]
C0810633
history of knee replacement
Beschrijving

Knee Replacement

Datatype

boolean

Alias
UMLS CUI [1]
C0086511
known sensitivity or allergy to any component of euflexxa
Beschrijving

Hypersensitivity Euflexxa Component

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1637315
UMLS CUI [1,3]
C1705248
inflammatory arthritis
Beschrijving

Arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0003864
previously received viscosupplementation therapy within 12 months of study enrollment
Beschrijving

Viscosupplementation

Datatype

boolean

Alias
UMLS CUI [1]
C2350507
intra-articular injection of corticosteroid to study joint within the past 3 months
Beschrijving

Intraarticular steroid injection Target Joint

Datatype

boolean

Alias
UMLS CUI [1,1]
C2064783
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022417
arthroscopic or open surgery within the previous 12 months or planned surgery to the study joint
Beschrijving

Arthroscopic Surgical Procedure Target Joint | Open Surgical Procedure Target Joint | Operative Surgical Procedure Planned Target Joint

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750934
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022417
UMLS CUI [2,1]
C4283938
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0022417
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1301732
UMLS CUI [3,3]
C1521840
UMLS CUI [3,4]
C0022417
concomitant medications of oral/parenteral corticosteroids
Beschrijving

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Parenteral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1518896
morbid obesity defined as body mass index (bmi) >40 kg/m2
Beschrijving

Obesity, Morbid | Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C0028756
UMLS CUI [2]
C1305855
active malignancy; an active systemic infection; recent high impact or high energy trauma (clinically defined) to the study joint
Beschrijving

Malignant Neoplasms | Sepsis | Trauma Target Joint

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0243026
UMLS CUI [3,1]
C3714660
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0022417
large knee effusion based on clinical exam or imaging
Beschrijving

Knee effusion Large Clinical examination | Knee effusion Large Imaging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0343166
UMLS CUI [1,2]
C0549177
UMLS CUI [1,3]
C1456356
UMLS CUI [2,1]
C0343166
UMLS CUI [2,2]
C0549177
UMLS CUI [2,3]
C0011923
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Similar models

Eligibility Knee Osteoarthritis NCT01895959

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 to 80 years
boolean
C0001779 (UMLS CUI [1])
Knee Osteoarthritis Symptomatic ACR Criteria
Item
symptomatic knee oa as defined by the american college of rheumatology criteria
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C3273747 (UMLS CUI [1,3])
X-Ray Computed Tomography Kellgren-Lawrence score
Item
kellgren-lawrence grade i, ii or iii on prior x-rays (take within 6 months of screening visit)
boolean
C0040405 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
Knee pain Visual Analog Pain Scale
Item
knee pain score >40 mm on a 100 mm visual analogue scale for > 15 days in the last month
boolean
C0231749 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
NSAIDs Dose Stable
Item
nsaids permitted if the dose has been stable for at least one month prior to baseline and stays stable during the study
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Euflexxa Recommended
Item
have been recommended for euflexxa treatment by physician
boolean
C1637315 (UMLS CUI [1,1])
C0034866 (UMLS CUI [1,2])
Knee effusion Clinical examination | Knee effusion Imaging
Item
knee effusion based on clinical exam or imaging
boolean
C0343166 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
C0343166 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication MRI | Pregnancy | Metal foreign body in eye region | Vascular clip | Pacemakers
Item
any contraindication to mri (pregnancy, metallic fragments in the eyes, vascular clips, pacemakers etc)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0562528 (UMLS CUI [3])
C0179992 (UMLS CUI [4])
C0810633 (UMLS CUI [5])
Knee Replacement
Item
history of knee replacement
boolean
C0086511 (UMLS CUI [1])
Hypersensitivity Euflexxa Component
Item
known sensitivity or allergy to any component of euflexxa
boolean
C0020517 (UMLS CUI [1,1])
C1637315 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Arthritis
Item
inflammatory arthritis
boolean
C0003864 (UMLS CUI [1])
Viscosupplementation
Item
previously received viscosupplementation therapy within 12 months of study enrollment
boolean
C2350507 (UMLS CUI [1])
Intraarticular steroid injection Target Joint
Item
intra-articular injection of corticosteroid to study joint within the past 3 months
boolean
C2064783 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
Arthroscopic Surgical Procedure Target Joint | Open Surgical Procedure Target Joint | Operative Surgical Procedure Planned Target Joint
Item
arthroscopic or open surgery within the previous 12 months or planned surgery to the study joint
boolean
C0750934 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C4283938 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C1521840 (UMLS CUI [3,3])
C0022417 (UMLS CUI [3,4])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Parenteral
Item
concomitant medications of oral/parenteral corticosteroids
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
Obesity, Morbid | Body mass index
Item
morbid obesity defined as body mass index (bmi) >40 kg/m2
boolean
C0028756 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Malignant Neoplasms | Sepsis | Trauma Target Joint
Item
active malignancy; an active systemic infection; recent high impact or high energy trauma (clinically defined) to the study joint
boolean
C0006826 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
C3714660 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0022417 (UMLS CUI [3,3])
Knee effusion Large Clinical examination | Knee effusion Large Imaging
Item
large knee effusion based on clinical exam or imaging
boolean
C0343166 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C0343166 (UMLS CUI [2,1])
C0549177 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
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