ID

20599

Descrição

A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA); ODM derived from: https://clinicaltrials.gov/show/NCT00536302

Link

https://clinicaltrials.gov/show/NCT00536302

Palavras-chave

Versões (1)
  1. 06/03/2017 06/03/2017 -
Transferido a

6 de março de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis (OA) NCT00536302

Inglês

Eligibility Knee Osteoarthritis (OA) NCT00536302

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 49 years
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
chronic knee discomfort based on the affirmative response to the question "during the past 6 months, have you had any pain in the knee more than half the days of the month ?"
Descrição

chronic knee discomfort, knee pain

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0745538
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0231749
womac pain subscale score ≥ 1
Descrição

womac pain subscale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3472647
tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
Descrição

Osteoarthritis, Knee; Structure of femorotibial joint; Structure of patellofemoral joint | X-ray of knee, anteroposterior and lateral views | x-ray of knee: osteophytes | x-ray of knee: narrowing of joint space

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0447795
UMLS CUI [1,3]
C0447801
UMLS CUI [2]
C2061628
UMLS CUI [3]
C2021136
UMLS CUI [4]
C2021131
clinical examination confirming knee pain or discomfort referable to the knee joint
Descrição

clinical examination, knee pain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0231749
prepared to refrain from use of glucosamine, chondroitin, same and doxycycline
Descrição

prepared to refrain from use of glucosamine, chondroitin, same and doxycycline

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0557021
UMLS CUI [1,2]
C0017718
UMLS CUI [2,1]
C0557021
UMLS CUI [2,2]
C0008454
UMLS CUI [3,1]
C0557021
UMLS CUI [3,2]
C0036002
UMLS CUI [4,1]
C0557021
UMLS CUI [4,2]
C0013090
stable medication and/or supplement use
Descrição

stable medication and/or supplement use

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348609
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
Descrição

use of glucosamine, chondroitin, diacerein or doxycycline

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017718
UMLS CUI [2]
C0008454
UMLS CUI [3]
C0057678
UMLS CUI [4]
C0013090
serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
Descrição

comorbidity, limited protocol compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0439801
UMLS CUI [2,2]
C0525058
individuals who are expected not to comply with the study protocol
Descrição

limited compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
plan to permanently relocate from the region during the trial period
Descrição

plan to permanently relocate from the region

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
planned knee arthroplasty in the study knee
Descrição

knee arthroplasty

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086511
active pathology of confounding origin which may cause pain, extending to the knee
Descrição

Pathology processes; Knee pain | Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0677042
UMLS CUI [1,2]
C0231749
UMLS CUI [2]
C0009488
pregnancy
Descrição

pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
any contra-indication to having an mri scan
Descrição

any contra-indication to having an mri scan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1301624
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Similar models

Eligibility Knee Osteoarthritis (OA) NCT00536302

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age > 49 years
boolean
C0001779 (UMLS CUI [1])
chronic knee discomfort, knee pain
Item
chronic knee discomfort based on the affirmative response to the question "during the past 6 months, have you had any pain in the knee more than half the days of the month ?"
boolean
C0745538 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0231749 (UMLS CUI [2])
womac pain subscale
Item
womac pain subscale score ≥ 1
boolean
C3472647 (UMLS CUI [1])
Osteoarthritis, Knee; Structure of femorotibial joint; Structure of patellofemoral joint | X-ray of knee, anteroposterior and lateral views | x-ray of knee: osteophytes | x-ray of knee: narrowing of joint space
Item
tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
boolean
C0409959 (UMLS CUI [1,1])
C0447795 (UMLS CUI [1,2])
C0447801 (UMLS CUI [1,3])
C2061628 (UMLS CUI [2])
C2021136 (UMLS CUI [3])
C2021131 (UMLS CUI [4])
clinical examination, knee pain
Item
clinical examination confirming knee pain or discomfort referable to the knee joint
boolean
C0031809 (UMLS CUI [1])
C0231749 (UMLS CUI [2])
prepared to refrain from use of glucosamine, chondroitin, same and doxycycline
Item
prepared to refrain from use of glucosamine, chondroitin, same and doxycycline
boolean
C0557021 (UMLS CUI [1,1])
C0017718 (UMLS CUI [1,2])
C0557021 (UMLS CUI [2,1])
C0008454 (UMLS CUI [2,2])
C0557021 (UMLS CUI [3,1])
C0036002 (UMLS CUI [3,2])
C0557021 (UMLS CUI [4,1])
C0013090 (UMLS CUI [4,2])
stable medication and/or supplement use
Item
stable medication and/or supplement use
boolean
C0013227 (UMLS CUI [1,1])
C2348609 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
use of glucosamine, chondroitin, diacerein or doxycycline
Item
use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
boolean
C0017718 (UMLS CUI [1])
C0008454 (UMLS CUI [2])
C0057678 (UMLS CUI [3])
C0013090 (UMLS CUI [4])
comorbidity, limited protocol compliance
Item
serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
boolean
C0009488 (UMLS CUI [1])
C0439801 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
limited compliance
Item
individuals who are expected not to comply with the study protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
plan to permanently relocate from the region
Item
plan to permanently relocate from the region during the trial period
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
knee arthroplasty
Item
planned knee arthroplasty in the study knee
boolean
C0086511 (UMLS CUI [1])
Pathology processes; Knee pain | Comorbidity
Item
active pathology of confounding origin which may cause pain, extending to the knee
boolean
C0677042 (UMLS CUI [1,1])
C0231749 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
any contra-indication to having an mri scan
Item
any contra-indication to having an mri scan
boolean
C0024485 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
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