ID

22648

Description

Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00398281

Link

https://clinicaltrials.gov/show/NCT00398281

Keywords

  1. 6/8/17 6/8/17 -
Uploaded on

June 8, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00398281

Eligibility Prostate Cancer NCT00398281

Criteria
Description

Criteria

suspected prostate cancer due to 1 of the following criteria:
Description

Prostate carcinoma Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0750491
prior abnormal digital rectal exam
Description

Digital Rectal Examination Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C1384593
UMLS CUI [1,2]
C0205161
elevated prostate-specific antigen (psa) ≥ 2.6 ng/ml within the past 90 days
Description

Raised prostate specific antigen

Data type

boolean

Alias
UMLS CUI [1]
C0178415
psa velocity > 0.75 ng/ml/year
Description

PSA Velocity

Data type

boolean

Alias
UMLS CUI [1]
C1518823
must be planning to undergo a transrectal ultrasound with biopsy
Description

Transrectal endoscopic ultrasound with biopsy Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2181472
UMLS CUI [1,2]
C1301732
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy
Description

Physical Well-being | Examination Transrectal Prolonged | Transrectal biopsy of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0517226
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0524447
UMLS CUI [2,3]
C0439590
UMLS CUI [3]
C0401641
must not be clinically unstable, severely ill, or moribund
Description

Unstable status Excluded | Illness Severe Excluded | Moribund Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2828389
UMLS CUI [3,1]
C0424547
UMLS CUI [3,2]
C2828389
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
more than 30 days since prior biopsy of the prostate
Description

Biopsy of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0194804
more than 1 week since prior acetylsalicylic acid or blood thinner
Description

Aspirin | Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C0003280
more than 30 days since prior participation in a clinical trial involving an investigational drug
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
no prior therapy for prostate cancer
Description

Prostate carcinoma Prior Therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0332197
no other concurrent 5-alpha reductase inhibitor
Description

5-alpha Reductase Inhibitors Additional Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2936788
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0332197

Similar models

Eligibility Prostate Cancer NCT00398281

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Prostate carcinoma Suspected
Item
suspected prostate cancer due to 1 of the following criteria:
boolean
C0600139 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
Digital Rectal Examination Abnormal
Item
prior abnormal digital rectal exam
boolean
C1384593 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Raised prostate specific antigen
Item
elevated prostate-specific antigen (psa) ≥ 2.6 ng/ml within the past 90 days
boolean
C0178415 (UMLS CUI [1])
PSA Velocity
Item
psa velocity > 0.75 ng/ml/year
boolean
C1518823 (UMLS CUI [1])
Transrectal endoscopic ultrasound with biopsy Planned
Item
must be planning to undergo a transrectal ultrasound with biopsy
boolean
C2181472 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Physical Well-being | Examination Transrectal Prolonged | Transrectal biopsy of prostate
Item
must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy
boolean
C0517226 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C0524447 (UMLS CUI [2,2])
C0439590 (UMLS CUI [2,3])
C0401641 (UMLS CUI [3])
Unstable status Excluded | Illness Severe Excluded | Moribund Excluded
Item
must not be clinically unstable, severely ill, or moribund
boolean
C0443343 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C0424547 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Biopsy of prostate
Item
more than 30 days since prior biopsy of the prostate
boolean
C0194804 (UMLS CUI [1])
Aspirin | Anticoagulants
Item
more than 1 week since prior acetylsalicylic acid or blood thinner
boolean
C0004057 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
more than 30 days since prior participation in a clinical trial involving an investigational drug
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Prostate carcinoma Prior Therapy Absent
Item
no prior therapy for prostate cancer
boolean
C0600139 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
5-alpha Reductase Inhibitors Additional Absent
Item
no other concurrent 5-alpha reductase inhibitor
boolean
C2936788 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])

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