ID

15837

Description

Celecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00136487

Link

https://clinicaltrials.gov/show/NCT00136487

Keywords

Versions (1)
  1. 6/15/16 6/15/16 -
Uploaded on

June 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00136487

English

Eligibility Prostate Cancer NCT00136487

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of prostate cancer
Description

prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C0600139
progression following prostatectomy or radiation to the prostate, defined as 3 psa rises, with each psa determination at least 4 weeks apart
Description

disease progression

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0138741
UMLS CUI [3,1]
C0033573
UMLS CUI [3,2]
C1522449
psa greater than or equal to 1.0 for men who had a prostatectomy
Description

psa

Data type

boolean

Alias
UMLS CUI [1]
C0138741
psa greater than or equal to 3.0 for men who were treated with primary radiation therapy (external beam and/or brachytherapy)
Description

psa radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C1522449
psa doubling time between 6 and 24 months
Description

psa doubling time

Data type

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C1521828
UMLS CUI [1,3]
C1518823
participants must be either fully active and asymptomatic or symptomatic but fully ambulatory
Description

fully active and asymptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0205177
UMLS CUI [2]
C0231221
adequate bone marrow function, kidney function and liver function as evidenced by laboratory results
Description

bone marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0005953
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of metastatic disease
Description

metastatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0027627
prior hormonal therapy for recurrent prostate cancer
Description

hormonal therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0278838
prior chemotherapy for recurrent or metastatic prostate cancer
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
radiation therapy within 6 months
Description

radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
patients allergic to non-steroidal anti-inflammatory drugs (nsaids), salicylates or sulfonamide-type medications who experience asthma or urticaria (hives) after taking aspirin or other nsaids
Description

allergy to nsaids

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003211
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0036077
patients taking a dose of aspirin greater than or equal to 325 mg a day within 4 weeks of study entry
Description

aspirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0178602
patients taking selective cox-2 inhibitors or any nsaids other than aspirin within 8 weeks of study entry
Description

selective cox-2 inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1257954
patients taking fluconazole, lithium or warfarin
Description

fluconazole lithium or warfarin

Data type

boolean

Alias
UMLS CUI [1]
C0016277
UMLS CUI [2]
C0023870
UMLS CUI [3]
C0043031
history of gastrointestinal or abdominal ulceration or any history of significant gastrointestinal bleeding in the past 12 months
Description

ulceration or bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0237938
UMLS CUI [2]
C0017181
any history of myocardial infarction in the past 12 months
Description

myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
any uncontrolled, serious medical or psychiatric illness
Description

serious medical or psychiatric illness

Data type

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Prostate Cancer NCT00136487

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
prostate cancer
Item
diagnosis of prostate cancer
boolean
C0600139 (UMLS CUI [1])
disease progression
Item
progression following prostatectomy or radiation to the prostate, defined as 3 psa rises, with each psa determination at least 4 weeks apart
boolean
C0242656 (UMLS CUI [1])
C0138741 (UMLS CUI [2])
C0033573 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
psa
Item
psa greater than or equal to 1.0 for men who had a prostatectomy
boolean
C0138741 (UMLS CUI [1])
psa radiation therapy
Item
psa greater than or equal to 3.0 for men who were treated with primary radiation therapy (external beam and/or brachytherapy)
boolean
C0138741 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
psa doubling time
Item
psa doubling time between 6 and 24 months
boolean
C0138741 (UMLS CUI [1,1])
C1521828 (UMLS CUI [1,2])
C1518823 (UMLS CUI [1,3])
fully active and asymptomatic
Item
participants must be either fully active and asymptomatic or symptomatic but fully ambulatory
boolean
C0205177 (UMLS CUI [1])
C0231221 (UMLS CUI [2])
bone marrow function
Item
adequate bone marrow function, kidney function and liver function as evidenced by laboratory results
boolean
C0005953 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
metastatic disease
Item
evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
hormonal therapy
Item
prior hormonal therapy for recurrent prostate cancer
boolean
C0279025 (UMLS CUI [1,1])
C0278838 (UMLS CUI [1,2])
chemotherapy
Item
prior chemotherapy for recurrent or metastatic prostate cancer
boolean
C0392920 (UMLS CUI [1])
radiation therapy
Item
radiation therapy within 6 months
boolean
C1522449 (UMLS CUI [1])
allergy to nsaids
Item
patients allergic to non-steroidal anti-inflammatory drugs (nsaids), salicylates or sulfonamide-type medications who experience asthma or urticaria (hives) after taking aspirin or other nsaids
boolean
C0020517 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0036077 (UMLS CUI [2,2])
aspirin
Item
patients taking a dose of aspirin greater than or equal to 325 mg a day within 4 weeks of study entry
boolean
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
selective cox-2 inhibitors
Item
patients taking selective cox-2 inhibitors or any nsaids other than aspirin within 8 weeks of study entry
boolean
C1257954 (UMLS CUI [1])
fluconazole lithium or warfarin
Item
patients taking fluconazole, lithium or warfarin
boolean
C0016277 (UMLS CUI [1])
C0023870 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
ulceration or bleeding
Item
history of gastrointestinal or abdominal ulceration or any history of significant gastrointestinal bleeding in the past 12 months
boolean
C0237938 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
myocardial infarction
Item
any history of myocardial infarction in the past 12 months
boolean
C0027051 (UMLS CUI [1])
serious medical or psychiatric illness
Item
any uncontrolled, serious medical or psychiatric illness
boolean
C0009488 (UMLS CUI [1])
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