ID

33783

Description

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

Lien

https://clinicaltrials.gov/show/NCT01773226

Mots-clés

  1. 27/12/2018 27/12/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 décembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Gonarthrosis NCT01773226

Eligibility Gonarthrosis NCT01773226

Eligibility Criteria
Description

Eligibility Criteria

male or female ≥40 years.
Description

Age

Type de données

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.
Description

Protocol Compliance

Type de données

boolean

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

Radiography of knee Standing Kellgren-Lawrence score

Type de données

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.
Description

Knee pain Frequency

Type de données

boolean

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

Unilateral primary osteoarthritis of knee

Type de données

boolean

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

Body mass index

Type de données

boolean

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

Conservative Treatment failed Osteoarthritis

Type de données

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).
Description

Informed Consent

Type de données

boolean

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

Avoidance Therapy Topical Pain | Avoidance Intraarticular Corticosteroid | Avoidance Viscosupplementation

Type de données

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.
Description

Avoidance Pharmaceutical Preparations Systemic Pain

Type de données

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
Type
Description | Question | Decode (Coded Value)
Type de données
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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