ID

33783

Descrição

Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA); ODM derived from: https://clinicaltrials.gov/show/NCT01773226

Link

https://clinicaltrials.gov/show/NCT01773226

Palavras-chave

  1. 27/12/2018 27/12/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de dezembro de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Gonarthrosis NCT01773226

Eligibility Gonarthrosis NCT01773226

Eligibility Criteria
Descrição

Eligibility Criteria

male or female ≥40 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
a standing radiograph of the knee showing a kellgren grade of 2 or 3
Descrição

Radiography of knee Standing Kellgren-Lawrence score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0845957
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C3177117
frequency of knee pain on most days over the last month.
Descrição

Knee pain Frequency

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0439603
diagnosis of unilateral knee oa
Descrição

Unilateral primary osteoarthritis of knee

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2893932
body mass index (bmi) ≤40 kg/m2.
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
failed conservative oa therapy.
Descrição

Conservative Treatment failed Osteoarthritis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0459914
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0029408
signed an independent ethics committee (iec)-approved informed consent form (icf).
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
Descrição

Avoidance Therapy Topical Pain | Avoidance Intraarticular Corticosteroid | Avoidance Viscosupplementation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1522168
UMLS CUI [1,4]
C0030193
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C4054701
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C2350507
willingness to abstain from systemic pain medications except rescue medication.
Descrição

Avoidance Pharmaceutical Preparations Systemic Pain

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205373
UMLS CUI [1,4]
C0030193

Similar models

Eligibility Gonarthrosis NCT01773226

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
male or female ≥40 years.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
boolean
C0525058 (UMLS CUI [1])
Radiography of knee Standing Kellgren-Lawrence score
Item
a standing radiograph of the knee showing a kellgren grade of 2 or 3
boolean
C0845957 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
Knee pain Frequency
Item
frequency of knee pain on most days over the last month.
boolean
C0231749 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Unilateral primary osteoarthritis of knee
Item
diagnosis of unilateral knee oa
boolean
C2893932 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≤40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Conservative Treatment failed Osteoarthritis
Item
failed conservative oa therapy.
boolean
C0459914 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
Informed Consent
Item
signed an independent ethics committee (iec)-approved informed consent form (icf).
boolean
C0021430 (UMLS CUI [1])
Avoidance Therapy Topical Pain | Avoidance Intraarticular Corticosteroid | Avoidance Viscosupplementation
Item
willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
boolean
C0870186 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1522168 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])
C0870186 (UMLS CUI [2,1])
C4054701 (UMLS CUI [2,2])
C0870186 (UMLS CUI [3,1])
C2350507 (UMLS CUI [3,2])
Avoidance Pharmaceutical Preparations Systemic Pain
Item
willingness to abstain from systemic pain medications except rescue medication.
boolean
C0870186 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])

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