ID

40774

Description

A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01985165

Link

https://clinicaltrials.gov/show/NCT01985165

Keywords

  1. 5/11/20 5/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 11, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Knee Osteoarthritis NCT01985165

Eligibility Knee Osteoarthritis NCT01985165

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged form 18 years to 75 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with osteoarthritis of the knee according to the american college of rheumatology
Description

Knee Osteoarthritis ACR Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3273747
functional capacity class of ⅰ-ⅲ
Description

Functional Status New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0598463
UMLS CUI [1,2]
C1275491
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unstable angina
Description

Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
history of myocardial infarction within the last 6 months
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
stroke in the 6 months before screening
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
new york heart association class ⅲ-ⅳ congestive heart-failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
systolic blood pressure>180mmhg,and/or diastolic blood pressure>100mmhg
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
peptic ulcer
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
known contraindications to non-steroidal anti-inflammatory drug(nsaid)
Description

Medical contraindication Non-Steroidal Anti-Inflammatory Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003211
received aspirin within 3 days of baseline visit
Description

Aspirin Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0332185
aspirin dosage>150mg/d
Description

Aspirin Dosage mg/d

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439422
known to be allergic to sulfa and cox-2 inhibitors
Description

Allergy to sulfonamides | Hypersensitivity cox-2 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0038757
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1257954
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>2 times upper limit of normal
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
blood urine nitrogen>1.5 times upper limit of normal
Description

Blood urea nitrogen increased

Data type

boolean

Alias
UMLS CUI [1]
C0151539

Similar models

Eligibility Knee Osteoarthritis NCT01985165

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged form 18 years to 75 years old
boolean
C0001779 (UMLS CUI [1])
Knee Osteoarthritis ACR Criteria
Item
diagnosed with osteoarthritis of the knee according to the american college of rheumatology
boolean
C0409959 (UMLS CUI [1,1])
C3273747 (UMLS CUI [1,2])
Functional Status New York Heart Association Classification
Item
functional capacity class of ⅰ-ⅲ
boolean
C0598463 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Angina, Unstable
Item
unstable angina
boolean
C0002965 (UMLS CUI [1])
Myocardial Infarction
Item
history of myocardial infarction within the last 6 months
boolean
C0027051 (UMLS CUI [1])
Cerebrovascular accident
Item
stroke in the 6 months before screening
boolean
C0038454 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
new york heart association class ⅲ-ⅳ congestive heart-failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure>180mmhg,and/or diastolic blood pressure>100mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Peptic Ulcer
Item
peptic ulcer
boolean
C0030920 (UMLS CUI [1])
Medical contraindication Non-Steroidal Anti-Inflammatory Agents
Item
known contraindications to non-steroidal anti-inflammatory drug(nsaid)
boolean
C1301624 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
Aspirin Recent
Item
received aspirin within 3 days of baseline visit
boolean
C0004057 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Aspirin Dosage mg/d
Item
aspirin dosage>150mg/d
boolean
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439422 (UMLS CUI [1,3])
Allergy to sulfonamides | Hypersensitivity cox-2 Inhibitors
Item
known to be allergic to sulfa and cox-2 inhibitors
boolean
C0038757 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1257954 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>2 times upper limit of normal
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Blood urea nitrogen increased
Item
blood urine nitrogen>1.5 times upper limit of normal
boolean
C0151539 (UMLS CUI [1])

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