ID

40717

Descrição

Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI); ODM derived from: https://clinicaltrials.gov/show/NCT01226615

Link

https://clinicaltrials.gov/show/NCT01226615

Palavras-chave

Versões (1)
  1. 03/05/2020 03/05/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de maio de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01226615

Inglês

Eligibility Knee Osteoarthritis NCT01226615

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary knee oa according to acr criteria
Descrição

Primary osteoarthritis of knee

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2893931
oa of radiological stages 2 to 3 according to kellgren-lawrence
Descrição

Osteoarthritis Stage Kellgren-Lawrence score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C3177117
estable knee pain during the last months before to start the clinical trial
Descrição

Knee pain Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0449238
patients with pain as the vas≥50mm at baseline
Descrição

Pain Visual Analog Pain Scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0042815
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with skin conditions that could interfere in the clinical trial evaluation
Descrição

Skin condition Interferes with Evaluation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1719933
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
pregnant or breastfeeding woman
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with a history of alcoholism or other drug abuse
Descrição

Alcoholic Intoxication, Chronic | Drug abuse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013146
patients with an uncontrolled active psychiatric disorder
Descrição

Mental disorders Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
patients with other inflammatory or systemic conditions affecting other joints
Descrição

Inflammatory disorder Affecting Joints | Systemic disease Affecting Joints

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0022417
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0022417
patients who suffer more intense pain in the joint in another location
Descrição

Pain intense | Joint Other Location

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [2,1]
C0022417
UMLS CUI [2,2]
C1547118
patients unable to differentiate between symptoms caused by the knee in front of the joint study opposite
Descrição

Patients Differentiation Unable | Symptoms Knee Opposite

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C2945687
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C1521805
oa of radiological stages 1 or 4 according to kellgren-lawrence
Descrição

Osteoarthritis Stage Kellgren-Lawrence score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C3177117
other bone and articular diseases such as chondrocalcinosis, paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, wilson's disease, osteochondromatosis
Descrição

Bone Diseases | Arthropathy | Chondrocalcinosis present | Paget's disease | Rheumatoid Arthritis | Osteonecrosis, aseptic | Gout | Arthritis, Infectious | Ochronosis | Acromegaly | Hemochromatosis | Hepatolenticular Degeneration | Osteochondromatosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005940
UMLS CUI [2]
C0022408
UMLS CUI [3]
C0221621
UMLS CUI [4]
C0029401
UMLS CUI [5]
C0003873
UMLS CUI [6]
C0391980
UMLS CUI [7]
C0018099
UMLS CUI [8]
C0003869
UMLS CUI [9]
C0028817
UMLS CUI [10]
C0001206
UMLS CUI [11]
C0018995
UMLS CUI [12]
C0019202
UMLS CUI [13]
C0206641
patients with contraindications to perform an mri such as: certain tattoos, pacemakers, intracranial clips incompatible with mri, in the heart valves, hearing aids and other types of implants are incompatible with mri
Descrição

Medical contraindication MRI | Tattoo | Pacemakers | Clips Intracranial | Heart Valve | Hearing Aids | Implants

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C1366940
UMLS CUI [3]
C0810633
UMLS CUI [4,1]
C0175722
UMLS CUI [4,2]
C0524466
UMLS CUI [5]
C0018826
UMLS CUI [6]
C0018768
UMLS CUI [7]
C0021102
known allergy to chondroitin sulphate
Descrição

Hypersensitivity Chondroitin Sulfates

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0008466
washout period for oa treatments before beginning the study
Descrição

Washout Period Treatment Osteoarthritis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0029408
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Similar models

Eligibility Knee Osteoarthritis NCT01226615

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Primary osteoarthritis of knee
Item
primary knee oa according to acr criteria
boolean
C2893931 (UMLS CUI [1])
Osteoarthritis Stage Kellgren-Lawrence score
Item
oa of radiological stages 2 to 3 according to kellgren-lawrence
boolean
C0029408 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
Knee pain Duration
Item
estable knee pain during the last months before to start the clinical trial
boolean
C0231749 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Pain Visual Analog Pain Scale
Item
patients with pain as the vas≥50mm at baseline
boolean
C0030193 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Skin condition Interferes with Evaluation
Item
patients with skin conditions that could interfere in the clinical trial evaluation
boolean
C1719933 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Alcoholic Intoxication, Chronic | Drug abuse
Item
patients with a history of alcoholism or other drug abuse
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Mental disorders Uncontrolled
Item
patients with an uncontrolled active psychiatric disorder
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Inflammatory disorder Affecting Joints | Systemic disease Affecting Joints
Item
patients with other inflammatory or systemic conditions affecting other joints
boolean
C1290884 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
Pain intense | Joint Other Location
Item
patients who suffer more intense pain in the joint in another location
boolean
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0022417 (UMLS CUI [2,1])
C1547118 (UMLS CUI [2,2])
Patients Differentiation Unable | Symptoms Knee Opposite
Item
patients unable to differentiate between symptoms caused by the knee in front of the joint study opposite
boolean
C0030705 (UMLS CUI [1,1])
C2945687 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C1521805 (UMLS CUI [2,3])
Osteoarthritis Stage Kellgren-Lawrence score
Item
oa of radiological stages 1 or 4 according to kellgren-lawrence
boolean
C0029408 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
Bone Diseases | Arthropathy | Chondrocalcinosis present | Paget's disease | Rheumatoid Arthritis | Osteonecrosis, aseptic | Gout | Arthritis, Infectious | Ochronosis | Acromegaly | Hemochromatosis | Hepatolenticular Degeneration | Osteochondromatosis
Item
other bone and articular diseases such as chondrocalcinosis, paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, wilson's disease, osteochondromatosis
boolean
C0005940 (UMLS CUI [1])
C0022408 (UMLS CUI [2])
C0221621 (UMLS CUI [3])
C0029401 (UMLS CUI [4])
C0003873 (UMLS CUI [5])
C0391980 (UMLS CUI [6])
C0018099 (UMLS CUI [7])
C0003869 (UMLS CUI [8])
C0028817 (UMLS CUI [9])
C0001206 (UMLS CUI [10])
C0018995 (UMLS CUI [11])
C0019202 (UMLS CUI [12])
C0206641 (UMLS CUI [13])
Medical contraindication MRI | Tattoo | Pacemakers | Clips Intracranial | Heart Valve | Hearing Aids | Implants
Item
patients with contraindications to perform an mri such as: certain tattoos, pacemakers, intracranial clips incompatible with mri, in the heart valves, hearing aids and other types of implants are incompatible with mri
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1366940 (UMLS CUI [2])
C0810633 (UMLS CUI [3])
C0175722 (UMLS CUI [4,1])
C0524466 (UMLS CUI [4,2])
C0018826 (UMLS CUI [5])
C0018768 (UMLS CUI [6])
C0021102 (UMLS CUI [7])
Hypersensitivity Chondroitin Sulfates
Item
known allergy to chondroitin sulphate
boolean
C0020517 (UMLS CUI [1,1])
C0008466 (UMLS CUI [1,2])
Washout Period Treatment Osteoarthritis
Item
washout period for oa treatments before beginning the study
boolean
C1710661 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
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