ID

40763

Description

NSAID Treatment in Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01860833

Link

https://clinicaltrials.gov/show/NCT01860833

Keywords

  1. 5/9/20 5/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 9, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Knee Osteoarthritis NCT01860833

Eligibility Knee Osteoarthritis NCT01860833

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients eligible for the study were:
Description

Patient eligible for clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C1302261
older than 50 years and
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
had primary knee oa diagnosed according to the clinical and radiological criteria of the american rheumatism association.
Description

Primary osteoarthritis of knee ACR Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C2893931
UMLS CUI [1,2]
C3273747
further inclusion criteria were:
Description

Inclusion criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
clinical signs of joint inflammation (warmth, swelling or effusion) and
Description

Clinical signs Joint inflammation | Warmth | Swelling | Effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0003864
UMLS CUI [2]
C0392197
UMLS CUI [3]
C0038999
UMLS CUI [4]
C0013687
a disease severity grade 2 or 3 according to the kellgren-lawrence classification
Description

Disease severity Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0521117
UMLS CUI [1,2]
C3177117
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergy to nsaids,
Description

Allergy to nonsteroidal anti-inflammatory agents

Data type

boolean

Alias
UMLS CUI [1]
C0746949
progressive serious medical conditions (such as cancer, aids or end-stage renal disease),
Description

Medical condition Serious Progressive | Malignant Neoplasms | AIDS | Kidney Failure, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205329
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0001175
UMLS CUI [4]
C0022661
history of gastrointestinal ulcer or bleeding,
Description

Gastrointestinal ulcer | Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0237938
UMLS CUI [2]
C0017181
a hemoglobin concentration lower than 11.5 g/dl,
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or
Description

Kidney Diseases | Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0700225
liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).
Description

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904

Similar models

Eligibility Knee Osteoarthritis NCT01860833

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient eligible for clinical trial
Item
patients eligible for the study were:
boolean
C1302261 (UMLS CUI [1])
Age
Item
older than 50 years and
boolean
C0001779 (UMLS CUI [1])
Primary osteoarthritis of knee ACR Criteria
Item
had primary knee oa diagnosed according to the clinical and radiological criteria of the american rheumatism association.
boolean
C2893931 (UMLS CUI [1,1])
C3273747 (UMLS CUI [1,2])
Inclusion criteria Additional
Item
further inclusion criteria were:
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Clinical signs Joint inflammation | Warmth | Swelling | Effusion
Item
clinical signs of joint inflammation (warmth, swelling or effusion) and
boolean
C3540840 (UMLS CUI [1,1])
C0003864 (UMLS CUI [1,2])
C0392197 (UMLS CUI [2])
C0038999 (UMLS CUI [3])
C0013687 (UMLS CUI [4])
Disease severity Kellgren-Lawrence score
Item
a disease severity grade 2 or 3 according to the kellgren-lawrence classification
boolean
C0521117 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Allergy to nonsteroidal anti-inflammatory agents
Item
allergy to nsaids,
boolean
C0746949 (UMLS CUI [1])
Medical condition Serious Progressive | Malignant Neoplasms | AIDS | Kidney Failure, Chronic
Item
progressive serious medical conditions (such as cancer, aids or end-stage renal disease),
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
C0001175 (UMLS CUI [3])
C0022661 (UMLS CUI [4])
Gastrointestinal ulcer | Gastrointestinal Hemorrhage
Item
history of gastrointestinal ulcer or bleeding,
boolean
C0237938 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
Hemoglobin measurement
Item
a hemoglobin concentration lower than 11.5 g/dl,
boolean
C0518015 (UMLS CUI [1])
Kidney Diseases | Serum creatinine raised
Item
renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or
boolean
C0022658 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial