ID

44023

Description

"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk; ODM derived from: https://clinicaltrials.gov/show/NCT00056407

Link

https://clinicaltrials.gov/show/NCT00056407

Keywords

Versions (2)
  1. 11/2/16 11/2/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Neoplasms, Prostate DRKS00009657 NCT00056407

English

Eligibility Neoplasms, Prostate NCT00056407

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent to participate in study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
have had a single negative prostate biopsy within 6 months prior to enrollment in study.
Description

Biopsy of prostate Negative Single

Data type

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0205171
have a psa (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a psa between 3.0 and 10 if over age 60.
Description

Prostate-Specific Antigen | Age

Data type

boolean

Alias
UMLS CUI [1]
C0138741
UMLS CUI [2]
C0001779
ability and will to participate in study for 4 years.
Description

Study Subject Participation Status Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than one previous negative prostate biopsy.
Description

Biopsy of prostate Negative Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C1265611
history of prostate cancer.
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
previous prostate surgery.
Description

Operation on prostate

Data type

boolean

Alias
UMLS CUI [1]
C0194790
inability to urinate requiring the need of a catheter during the previous 2 years.
Description

Unable to urinate | Catheter Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0849752
UMLS CUI [2,1]
C0085590
UMLS CUI [2,2]
C0686904
any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
Description

Condition Resulting in Urinary symptoms | Condition Resulting in Urine Flow Rate Change | Benign prostatic hypertrophy

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0426359
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0042036
UMLS CUI [2,4]
C2826285
UMLS CUI [2,5]
C0392747
UMLS CUI [3]
C1704272
cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
Description

Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
any unstable serious medical condition.
Description

Medical condition Serious Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0443343
use within the past 12 months of finasteride (proscar or propecia), dutasteride (avodart), testosterone, or drugs that can block the action of male hormones.
Description

Finasteride | Proscar | Propecia | Dutasteride | Avodart | Testosterone | Androgen Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0060389
UMLS CUI [2]
C0678149
UMLS CUI [3]
C0722858
UMLS CUI [4]
C0754659
UMLS CUI [5]
C1170079
UMLS CUI [6]
C0039601
UMLS CUI [7]
C0002842
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Similar models

Eligibility Neoplasms, Prostate NCT00056407

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent to participate in study.
boolean
C0021430 (UMLS CUI [1])
Biopsy of prostate Negative Single
Item
have had a single negative prostate biopsy within 6 months prior to enrollment in study.
boolean
C0194804 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
Prostate-Specific Antigen | Age
Item
have a psa (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a psa between 3.0 and 10 if over age 60.
boolean
C0138741 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Study Subject Participation Status Duration
Item
ability and will to participate in study for 4 years.
boolean
C2348568 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Biopsy of prostate Negative Quantity
Item
more than one previous negative prostate biopsy.
boolean
C0194804 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Prostate carcinoma
Item
history of prostate cancer.
boolean
C0600139 (UMLS CUI [1])
Operation on prostate
Item
previous prostate surgery.
boolean
C0194790 (UMLS CUI [1])
Unable to urinate | Catheter Patient need for
Item
inability to urinate requiring the need of a catheter during the previous 2 years.
boolean
C0849752 (UMLS CUI [1])
C0085590 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Condition Resulting in Urinary symptoms | Condition Resulting in Urine Flow Rate Change | Benign prostatic hypertrophy
Item
any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
boolean
C0348080 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0426359 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0042036 (UMLS CUI [2,3])
C2826285 (UMLS CUI [2,4])
C0392747 (UMLS CUI [2,5])
C1704272 (UMLS CUI [3])
Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
Medical condition Serious Unstable
Item
any unstable serious medical condition.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
Finasteride | Proscar | Propecia | Dutasteride | Avodart | Testosterone | Androgen Antagonists
Item
use within the past 12 months of finasteride (proscar or propecia), dutasteride (avodart), testosterone, or drugs that can block the action of male hormones.
boolean
C0060389 (UMLS CUI [1])
C0678149 (UMLS CUI [2])
C0722858 (UMLS CUI [3])
C0754659 (UMLS CUI [4])
C1170079 (UMLS CUI [5])
C0039601 (UMLS CUI [6])
C0002842 (UMLS CUI [7])
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