ID

44334

Descrição

Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers; ODM derived from: https://clinicaltrials.gov/show/NCT00020878 Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers. PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.

Link

https://clinicaltrials.gov/show/NCT00020878

Palavras-chave

Versões (2)
  1. 14/05/2019 14/05/2019 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

Jonsson Comprehensive Cancer Center

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY-NC 3.0
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Celecoxib in Preventing NSCLC NCT00020878

Inglês

Eligibility Criteria

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the participant older than 45 years of age?
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Has the participant smoked more than 20 pack years?
Descrição

Pack Years

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1277691
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
Is the participant concurrently using NSAIDs?
Descrição

Concurrent NSAID use

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4060806
UMLS CUI [1,2]
C0003211
Does the participant have hypersensitivity to celecoxib?
Descrição

Celecoxib hypersensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0538927
Does the participant have a documented allergic-type reaction to sulfonamides?
Descrição

Sulfonamide allergy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301725
UMLS CUI [1,2]
C1527304
UMLS CUI [1,3]
C0038760
Does the participant have a history of allergic reaction, urticaria or asthma to aspirin or other NSAIDs?
Descrição

Hypersensitivity reaction to aspiring or NSAIDs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1527304
UMLS CUI [1,3]
C0004057
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0042109
UMLS CUI [2,3]
C0004057
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0004096
UMLS CUI [3,3]
C0004057
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C1527304
UMLS CUI [4,3]
C0003211
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0042109
UMLS CUI [5,3]
C0003211
UMLS CUI [6,1]
C0262926
UMLS CUI [6,2]
C0004096
UMLS CUI [6,3]
C0003211
Does the participant have a history of liver dysfunction?
Descrição

Liver dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0086565
Does the participant have hypertension or cardiac conditions aggravated by fluid retention and edema?
Descrição

Fluid retention problems

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0436331
UMLS CUI [1,3]
C0268000
UMLS CUI [1,4]
C0013604
UMLS CUI [2,1]
C0262402
UMLS CUI [2,2]
C0436331
UMLS CUI [2,3]
C0268000
UMLS CUI [2,4]
C0013604
Does the participant have a previous history of gastrointestinal ulceration, bleeding, or perforation?
Descrição

Gastrointestinal ulcer complications

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0237938
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0017181
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0151664
Does the participant have renal dysfunction?
Descrição

Renal dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3279454
Does the participant have end stage respiratory disease?
Descrição

End-stage Respiratory Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205088
UMLS CUI [1,2]
C0035204
Does the participant have unstable angina?
Descrição

Unstable Angina

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002965
Does the participant have any other malignancy?
Descrição

Other malignancy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
Is the participant pregnant?
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
Does the participant have a concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2c9 and 2d6 enzymes?
Descrição

Cytochrom system interference

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4060806
UMLS CUI [1,2]
C1515926
UMLS CUI [1,3]
C0608437
UMLS CUI [1,4]
C0057223
Does the patient have concurrent medical conditions that may interfere with completion of tests, therapy, or the follow-up schedule?
Descrição

Interfering Medical Conditions

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0205197
UMLS CUI [1,5]
C0039593
UMLS CUI [2,1]
C0205476
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0205197
UMLS CUI [2,5]
C0087111
UMLS CUI [3,1]
C0205476
UMLS CUI [3,2]
C0348080
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0205197
UMLS CUI [3,5]
C1522577
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Similar models

Eligibility Criteria

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the participant older than 45 years of age?
boolean
C0001779 (UMLS CUI [1])
Pack Years
Item
Has the participant smoked more than 20 pack years?
boolean
C1277691 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Concurrent NSAID use
Item
Is the participant concurrently using NSAIDs?
boolean
C4060806 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
Celecoxib hypersensitivity
Item
Does the participant have hypersensitivity to celecoxib?
boolean
C0020517 (UMLS CUI [1,1])
C0538927 (UMLS CUI [1,2])
Sulfonamide allergy
Item
Does the participant have a documented allergic-type reaction to sulfonamides?
boolean
C1301725 (UMLS CUI [1,1])
C1527304 (UMLS CUI [1,2])
C0038760 (UMLS CUI [1,3])
Hypersensitivity reaction to aspiring or NSAIDs
Item
Does the participant have a history of allergic reaction, urticaria or asthma to aspirin or other NSAIDs?
boolean
C0262926 (UMLS CUI [1,1])
C1527304 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0042109 (UMLS CUI [2,2])
C0004057 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C0004057 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4,1])
C1527304 (UMLS CUI [4,2])
C0003211 (UMLS CUI [4,3])
C0262926 (UMLS CUI [5,1])
C0042109 (UMLS CUI [5,2])
C0003211 (UMLS CUI [5,3])
C0262926 (UMLS CUI [6,1])
C0004096 (UMLS CUI [6,2])
C0003211 (UMLS CUI [6,3])
Liver dysfunction
Item
Does the participant have a history of liver dysfunction?
boolean
C0262926 (UMLS CUI [1,1])
C0086565 (UMLS CUI [1,2])
Fluid retention problems
Item
Does the participant have hypertension or cardiac conditions aggravated by fluid retention and edema?
boolean
C0020538 (UMLS CUI [1,1])
C0436331 (UMLS CUI [1,2])
C0268000 (UMLS CUI [1,3])
C0013604 (UMLS CUI [1,4])
C0262402 (UMLS CUI [2,1])
C0436331 (UMLS CUI [2,2])
C0268000 (UMLS CUI [2,3])
C0013604 (UMLS CUI [2,4])
Gastrointestinal ulcer complications
Item
Does the participant have a previous history of gastrointestinal ulceration, bleeding, or perforation?
boolean
C0262926 (UMLS CUI [1,1])
C0237938 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0017181 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0151664 (UMLS CUI [3,2])
Renal dysfunction
Item
Does the participant have renal dysfunction?
boolean
C3279454 (UMLS CUI [1])
End-stage Respiratory Disease
Item
Does the participant have end stage respiratory disease?
boolean
C0205088 (UMLS CUI [1,1])
C0035204 (UMLS CUI [1,2])
Unstable Angina
Item
Does the participant have unstable angina?
boolean
C0002965 (UMLS CUI [1])
Other malignancy
Item
Does the participant have any other malignancy?
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Pregnancy
Item
Is the participant pregnant?
boolean
C0032961 (UMLS CUI [1])
Cytochrom system interference
Item
Does the participant have a concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2c9 and 2d6 enzymes?
boolean
C4060806 (UMLS CUI [1,1])
C1515926 (UMLS CUI [1,2])
C0608437 (UMLS CUI [1,3])
C0057223 (UMLS CUI [1,4])
Interfering Medical Conditions
Item
Does the patient have concurrent medical conditions that may interfere with completion of tests, therapy, or the follow-up schedule?
boolean
C0205476 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0039593 (UMLS CUI [1,5])
C0205476 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
C0087111 (UMLS CUI [2,5])
C0205476 (UMLS CUI [3,1])
C0348080 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
C1522577 (UMLS CUI [3,5])
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