ID

40771

Descripción

Loaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01919736

Link

https://clinicaltrials.gov/show/NCT01919736

Palabras clave

Versiones (1)
  1. 10/5/20 10/5/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 de mayo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01919736

Inglés

Eligibility Knee Osteoarthritis NCT01919736

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women
Descripción

Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
at least 35 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
mild oa patients with arthritic knee symptoms and kl score of 1-2
Descripción

Osteoarthritis Mild | Symptoms Arthritis of knee | Kellgren-Lawrence score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0240111
UMLS CUI [3]
C3177117
severe oa patients with arthritic knee symptoms and kl score of 3-4
Descripción

Osteoarthritis Severe | Symptoms Arthritis of knee | Kellgren-Lawrence score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0240111
UMLS CUI [3]
C3177117
knee symptoms in oa patients is defined as pain, aching, or stiffness on most days of a month during the past year or use of medication for treatment of knee pain on most days of a month during the past year
Descripción

Symptoms Knee Osteoarthritis | Pain days per month | Aching days per month | Stiffness days per month | Pharmacotherapy Knee pain

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0409959
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0556971
UMLS CUI [3,1]
C0234238
UMLS CUI [3,2]
C0556971
UMLS CUI [4,1]
C0427008
UMLS CUI [4,2]
C0556971
UMLS CUI [5,1]
C0013216
UMLS CUI [5,2]
C0231749
self reported knee pain (defined as medial compartment knee pain at least 1 day per week during each of the 6 weeks prior to participation) and at least 3 of the following 6 clinical indicators: age>50 years; morning stiffness<30 minutes duration; crepitus on active motion; tenderness of the bony margins of the knee joint; bony enlargement at the knee; and lack of palpable warmth of the synovium
Descripción

Knee pain Medial compartment days per week | Age | Morning stiffness Duration | Crepitus During Motion | Knee joint tender | Bony joint enlargement Knee | Synovium Warmth Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0447799
UMLS CUI [1,3]
C0677547
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0457086
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C0277964
UMLS CUI [4,2]
C0347984
UMLS CUI [4,3]
C0026597
UMLS CUI [5]
C0576134
UMLS CUI [6,1]
C0221610
UMLS CUI [6,2]
C0022742
UMLS CUI [7,1]
C0039099
UMLS CUI [7,2]
C0392197
UMLS CUI [7,3]
C0332268
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
current use of investigational drug
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
conditions other than oa which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, trochanteric bursitis, hip pain, lumbar pain)
Descripción

Condition Limiting Lower Extremity Function | Exception Osteoarthritis | Condition Limiting Lower Extremity Mobility | Condition Interferes with Evaluation Function | Degeneration Disc spinal | Painful feet | Foot Dysfunction | Peripheral Vascular Disease | Lumbar radiculopathy | Trochanteric bursitis | Hip pain | Lumbar Pain

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0023216
UMLS CUI [1,4]
C0031843
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0029408
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0023216
UMLS CUI [3,4]
C0080078
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C0031843
UMLS CUI [5,1]
C0011164
UMLS CUI [5,2]
C1556138
UMLS CUI [5,3]
C0521329
UMLS CUI [6]
C0857248
UMLS CUI [7]
C1704557
UMLS CUI [8]
C0085096
UMLS CUI [9]
C1263855
UMLS CUI [10]
C0151451
UMLS CUI [11]
C0019559
UMLS CUI [12]
C0024031
patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to mri
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0562528
UMLS CUI [2]
C0179992
UMLS CUI [3]
C0810633
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0024485
history of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the signal knee
Descripción

Joint Replacement | Fracture Intra-articular | Osteotomy Knee Affected | Arthroplasty Knee Affected | Meniscectomy Knee Affected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0185317
UMLS CUI [2,1]
C0016658
UMLS CUI [2,2]
C0442108
UMLS CUI [3,1]
C0029468
UMLS CUI [3,2]
C0022742
UMLS CUI [3,3]
C0392760
UMLS CUI [4,1]
C0003893
UMLS CUI [4,2]
C0022742
UMLS CUI [4,3]
C0392760
UMLS CUI [5,1]
C0187901
UMLS CUI [5,2]
C0022742
UMLS CUI [5,3]
C0392760
history of other disease that may involve the study joint including systemic inflammatory disease, crystalline disease, knee infection of the signal knee, avascular necrosis, paget's disease or tumors
Descripción

Other medical condition Involving Target Joint | Inflammatory disorder Systemic | Crystal Arthropathy | Knee infection | Avascular necrosis | Paget's disease | Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0022417
UMLS CUI [2,1]
C1290884
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0152087
UMLS CUI [4]
C1400580
UMLS CUI [5]
C3887513
UMLS CUI [6]
C0029401
UMLS CUI [7]
C0027651
self reported heart condition that limits any daily physical activity
Descripción

Heart condition Limiting Activities of Daily Living

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3842523
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0001288
patients who are pregnant
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Knee Osteoarthritis NCT01919736

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
men and women
boolean
C0079399 (UMLS CUI [1])
Age
Item
at least 35 years of age
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis Mild | Symptoms Arthritis of knee | Kellgren-Lawrence score
Item
mild oa patients with arthritic knee symptoms and kl score of 1-2
boolean
C0029408 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0240111 (UMLS CUI [2,2])
C3177117 (UMLS CUI [3])
Osteoarthritis Severe | Symptoms Arthritis of knee | Kellgren-Lawrence score
Item
severe oa patients with arthritic knee symptoms and kl score of 3-4
boolean
C0029408 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0240111 (UMLS CUI [2,2])
C3177117 (UMLS CUI [3])
Symptoms Knee Osteoarthritis | Pain days per month | Aching days per month | Stiffness days per month | Pharmacotherapy Knee pain
Item
knee symptoms in oa patients is defined as pain, aching, or stiffness on most days of a month during the past year or use of medication for treatment of knee pain on most days of a month during the past year
boolean
C1457887 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0556971 (UMLS CUI [2,2])
C0234238 (UMLS CUI [3,1])
C0556971 (UMLS CUI [3,2])
C0427008 (UMLS CUI [4,1])
C0556971 (UMLS CUI [4,2])
C0013216 (UMLS CUI [5,1])
C0231749 (UMLS CUI [5,2])
Knee pain Medial compartment days per week | Age | Morning stiffness Duration | Crepitus During Motion | Knee joint tender | Bony joint enlargement Knee | Synovium Warmth Lacking
Item
self reported knee pain (defined as medial compartment knee pain at least 1 day per week during each of the 6 weeks prior to participation) and at least 3 of the following 6 clinical indicators: age>50 years; morning stiffness<30 minutes duration; crepitus on active motion; tenderness of the bony margins of the knee joint; bony enlargement at the knee; and lack of palpable warmth of the synovium
boolean
C0231749 (UMLS CUI [1,1])
C0447799 (UMLS CUI [1,2])
C0677547 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C0457086 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0277964 (UMLS CUI [4,1])
C0347984 (UMLS CUI [4,2])
C0026597 (UMLS CUI [4,3])
C0576134 (UMLS CUI [5])
C0221610 (UMLS CUI [6,1])
C0022742 (UMLS CUI [6,2])
C0039099 (UMLS CUI [7,1])
C0392197 (UMLS CUI [7,2])
C0332268 (UMLS CUI [7,3])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
current use of investigational drug
boolean
C0013230 (UMLS CUI [1])
Condition Limiting Lower Extremity Function | Exception Osteoarthritis | Condition Limiting Lower Extremity Mobility | Condition Interferes with Evaluation Function | Degeneration Disc spinal | Painful feet | Foot Dysfunction | Peripheral Vascular Disease | Lumbar radiculopathy | Trochanteric bursitis | Hip pain | Lumbar Pain
Item
conditions other than oa which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, trochanteric bursitis, hip pain, lumbar pain)
boolean
C0348080 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023216 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0023216 (UMLS CUI [3,3])
C0080078 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0031843 (UMLS CUI [4,4])
C0011164 (UMLS CUI [5,1])
C1556138 (UMLS CUI [5,2])
C0521329 (UMLS CUI [5,3])
C0857248 (UMLS CUI [6])
C1704557 (UMLS CUI [7])
C0085096 (UMLS CUI [8])
C1263855 (UMLS CUI [9])
C0151451 (UMLS CUI [10])
C0019559 (UMLS CUI [11])
C0024031 (UMLS CUI [12])
Metal foreign body in eye region | Vascular clip | Pacemakers | Medical contraindication MRI
Item
patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to mri
boolean
C0562528 (UMLS CUI [1])
C0179992 (UMLS CUI [2])
C0810633 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
Joint Replacement | Fracture Intra-articular | Osteotomy Knee Affected | Arthroplasty Knee Affected | Meniscectomy Knee Affected
Item
history of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the signal knee
boolean
C0185317 (UMLS CUI [1])
C0016658 (UMLS CUI [2,1])
C0442108 (UMLS CUI [2,2])
C0029468 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0003893 (UMLS CUI [4,1])
C0022742 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0187901 (UMLS CUI [5,1])
C0022742 (UMLS CUI [5,2])
C0392760 (UMLS CUI [5,3])
Other medical condition Involving Target Joint | Inflammatory disorder Systemic | Crystal Arthropathy | Knee infection | Avascular necrosis | Paget's disease | Neoplasms
Item
history of other disease that may involve the study joint including systemic inflammatory disease, crystalline disease, knee infection of the signal knee, avascular necrosis, paget's disease or tumors
boolean
C3843040 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0022417 (UMLS CUI [1,4])
C1290884 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0152087 (UMLS CUI [3])
C1400580 (UMLS CUI [4])
C3887513 (UMLS CUI [5])
C0029401 (UMLS CUI [6])
C0027651 (UMLS CUI [7])
Heart condition Limiting Activities of Daily Living
Item
self reported heart condition that limits any daily physical activity
boolean
C3842523 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0001288 (UMLS CUI [1,3])
Pregnancy
Item
patients who are pregnant
boolean
C0032961 (UMLS CUI [1])
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