ID

40774

Descripción

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

Palabras clave

Versiones (1)
  1. 11/5/20 11/5/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de mayo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01985165

Inglés

Eligibility Knee Osteoarthritis NCT01985165

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

Knee Osteoarthritis ACR Criteria

Tipo de datos

boolean

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

Functional Status New York Heart Association Classification

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
unstable angina
Descripción

Angina, Unstable

Tipo de datos

boolean

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

Myocardial Infarction

Tipo de datos

boolean

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

Cerebrovascular accident

Tipo de datos

boolean

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

Congestive heart failure New York Heart Association Classification

Tipo de datos

boolean

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

Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

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

Peptic Ulcer

Tipo de datos

boolean

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

Medical contraindication Non-Steroidal Anti-Inflammatory Agents

Tipo de datos

boolean

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

Aspirin Recent

Tipo de datos

boolean

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

Aspirin Dosage mg/d

Tipo de datos

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
Descripción

Allergy to sulfonamides | Hypersensitivity cox-2 Inhibitors

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de datos

boolean

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

Blood urea nitrogen increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151539
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Similar models

Eligibility Knee Osteoarthritis NCT01985165

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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