ID

44724

Description

Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.; ODM derived from: https://clinicaltrials.gov/show/NCT01233739

Link

https://clinicaltrials.gov/show/NCT01233739

Keywords

  1. 9/28/21 9/28/21 -
Copyright Holder

Juan A. Arnaiz

Uploaded on

September 28, 2021

DOI

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License

Creative Commons BY-NC 4.0

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Eligibility Rhizarthrosis NCT01233739

Eligibility Rhizarthrosis NCT01233739

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
both sex patients
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
age between 45 to 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
with mechanical pain at the trapezium-thumb metacarpal joint of more than 3 months duration
Description

Mechanical pain at the trapezium-thumb metacarpal joint of more than 3 months duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0224622
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C0449238
grade ii or iii eaton & glickel rhizarthrosis radiological diagnose
Description

Eaton & glickel rhizarthrosis radiological diagnose

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0224622
UMLS CUI [1,3]
C0679228
UMLS CUI [1,4]
C0205483
pain at inclusion of >= 40 mm at a visual analogue scale
Description

Visual analog scale pain score

Data type

boolean

Alias
UMLS CUI [1]
C2732809
without rehabilitation treatment or infiltration in the last 6 months
Description

Absence of a recent rehabilitation | Absence of a recent infiltration

Data type

boolean

Alias
UMLS CUI [1,1]
C0034991
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1523986
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C0332197
who accept to participate and sign informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with rhizarthrosis resulted from rheumatic disease
Description

Rhizarthrosis resulted from rheumatic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1328502
UMLS CUI [1,2]
C3495832
UMLS CUI [1,3]
C0678226
patients with joint surgery or traumatic background
Description

Joint surgery | Trauma

Data type

boolean

Alias
UMLS CUI [1]
C0185132
UMLS CUI [2]
C3714660
illiterate patients or unable to understand informed consent
Description

Illiteracy | Informed consent unable

Data type

boolean

Alias
UMLS CUI [1]
C0020899
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
patients with previous neuropsychopathology enough severe to unable participation at the study
Description

Severe nervous system disorder | Severe mental disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205082
patients with peripheral sensory impairment due to diabetes, peripheral neuropathy or central neurological sequelae of disease in the affected limb that can alter sensory perception
Description

Sensory impairment due to diabetes | Peripheral neuropathy | Central neurological sequelae of disease in the affected limb that can alter sensory perception

Data type

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0011849
UMLS CUI [2]
C0031117
UMLS CUI [3,1]
C0007682
UMLS CUI [3,2]
C0243088
UMLS CUI [3,3]
C0449642
UMLS CUI [3,4]
C0015385
UMLS CUI [3,5]
C0036658
UMLS CUI [3,6]
C0392760
patients with coagulopathy
Description

Coagulopathy

Data type

boolean

Alias
UMLS CUI [1]
C0005779
inflammation for other process at the joint at study
Description

Inflammation for other process at the joint

Data type

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0021368
UMLS CUI [1,4]
C0205394
in treatment with non-steroidal anti-inflammatory drug in the last 7 days and/or corticosteroid in the last 30 days
Description

Non-steroidal anti-inflammatory drug recently | Corticosteroid recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0332185
allergy or hypersensibility at chondroitin sulfate or its excipients
Description

Hypersensitivity at chondroitin sulfate or its excipients

Data type

boolean

Alias
UMLS CUI [1,1]
C0008466
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0008466
UMLS CUI [2,2]
C0015237
UMLS CUI [2,3]
C0020517
pregnant or breastfeeding woman
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Rhizarthrosis NCT01233739

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
both sex patients
boolean
C0079399 (UMLS CUI [1])
Age
Item
age between 45 to 75 years
boolean
C0001779 (UMLS CUI [1])
Mechanical pain at the trapezium-thumb metacarpal joint of more than 3 months duration
Item
with mechanical pain at the trapezium-thumb metacarpal joint of more than 3 months duration
boolean
C0224622 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Eaton & glickel rhizarthrosis radiological diagnose
Item
grade ii or iii eaton & glickel rhizarthrosis radiological diagnose
boolean
C0029408 (UMLS CUI [1,1])
C0224622 (UMLS CUI [1,2])
C0679228 (UMLS CUI [1,3])
C0205483 (UMLS CUI [1,4])
Visual analog scale pain score
Item
pain at inclusion of >= 40 mm at a visual analogue scale
boolean
C2732809 (UMLS CUI [1])
Absence of a recent rehabilitation | Absence of a recent infiltration
Item
without rehabilitation treatment or infiltration in the last 6 months
boolean
C0034991 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1523986 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Informed consent
Item
who accept to participate and sign informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Rhizarthrosis resulted from rheumatic disease
Item
patients with rhizarthrosis resulted from rheumatic disease
boolean
C1328502 (UMLS CUI [1,1])
C3495832 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
Joint surgery | Trauma
Item
patients with joint surgery or traumatic background
boolean
C0185132 (UMLS CUI [1])
C3714660 (UMLS CUI [2])
Illiteracy | Informed consent unable
Item
illiterate patients or unable to understand informed consent
boolean
C0020899 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Severe nervous system disorder | Severe mental disorder
Item
patients with previous neuropsychopathology enough severe to unable participation at the study
boolean
C0027765 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Sensory impairment due to diabetes | Peripheral neuropathy | Central neurological sequelae of disease in the affected limb that can alter sensory perception
Item
patients with peripheral sensory impairment due to diabetes, peripheral neuropathy or central neurological sequelae of disease in the affected limb that can alter sensory perception
boolean
C0151313 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0031117 (UMLS CUI [2])
C0007682 (UMLS CUI [3,1])
C0243088 (UMLS CUI [3,2])
C0449642 (UMLS CUI [3,3])
C0015385 (UMLS CUI [3,4])
C0036658 (UMLS CUI [3,5])
C0392760 (UMLS CUI [3,6])
Coagulopathy
Item
patients with coagulopathy
boolean
C0005779 (UMLS CUI [1])
Inflammation for other process at the joint
Item
inflammation for other process at the joint at study
boolean
C0022417 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021368 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Non-steroidal anti-inflammatory drug recently | Corticosteroid recently
Item
in treatment with non-steroidal anti-inflammatory drug in the last 7 days and/or corticosteroid in the last 30 days
boolean
C0003211 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Hypersensitivity at chondroitin sulfate or its excipients
Item
allergy or hypersensibility at chondroitin sulfate or its excipients
boolean
C0008466 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0008466 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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