ID

23690

Beschrijving

Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00515112

Link

https://clinicaltrials.gov/show/NCT00515112

Trefwoorden

  1. 10-07-17 10-07-17 -
Geüploaded op

10 juli 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00515112

Eligibility Prostate Cancer NCT00515112

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
prostate cancer
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy)
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1,1]
C0194790
UMLS CUI [1,2]
C0948317
patient was surgically or pharmacologically castrated at least 6 months prior to starting the study
Beschrijving

ID.3

Datatype

boolean

Alias
UMLS CUI [1]
C1319065
patient must have had a previous trial of anti-androgen therapy
Beschrijving

ID.4

Datatype

boolean

Alias
UMLS CUI [1]
C0279492
patient must have a rising psa
Beschrijving

ID.5

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
no evidence of distant metastatic disease
Beschrijving

ID.6

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
ecog performance status < 2
Beschrijving

ID.7

Datatype

boolean

age >18 years
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients must have normal hepatic function
Beschrijving

ID.9

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium)
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0203608
patients may not be receiving any other investigational agents
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Beschrijving

ID.12

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1321605
patients receiving renal dialysis
Beschrijving

ID.13

Datatype

boolean

Alias
UMLS CUI [1]
C0011946
patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded
Beschrijving

ID.14

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024115
patients who have known hypersensitivity to any of the androgel ingredients, including testosterone that is chemically synthesized from soy
Beschrijving

ID.15

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0875960

Similar models

Eligibility Prostate Cancer NCT00515112

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
prostate cancer
boolean
C0007112 (UMLS CUI [1])
ID.2
Item
patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy)
boolean
C0194790 (UMLS CUI [1,1])
C0948317 (UMLS CUI [1,2])
ID.3
Item
patient was surgically or pharmacologically castrated at least 6 months prior to starting the study
boolean
C1319065 (UMLS CUI [1])
ID.4
Item
patient must have had a previous trial of anti-androgen therapy
boolean
C0279492 (UMLS CUI [1])
ID.5
Item
patient must have a rising psa
boolean
C0201544 (UMLS CUI [1])
ID.6
Item
no evidence of distant metastatic disease
boolean
C0027627 (UMLS CUI [1])
ID.7
Item
ecog performance status < 2
boolean
ID.8
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
ID.9
Item
patients must have normal hepatic function
boolean
C0232741 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.10
Item
patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium)
boolean
C0677881 (UMLS CUI [1,1])
C0203608 (UMLS CUI [1,2])
ID.11
Item
patients may not be receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
ID.12
Item
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0012634 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
ID.13
Item
patients receiving renal dialysis
boolean
C0011946 (UMLS CUI [1])
ID.14
Item
patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded
boolean
C0024115 (UMLS CUI [1,1])
ID.15
Item
patients who have known hypersensitivity to any of the androgel ingredients, including testosterone that is chemically synthesized from soy
boolean
C0020517 (UMLS CUI [1,1])
C0875960 (UMLS CUI [1,2])

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