ID

19072

Description

PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone; ODM derived from: https://clinicaltrials.gov/show/NCT00291005

Link

https://clinicaltrials.gov/show/NCT00291005

Keywords

Versions (1)
  1. 12/3/16 12/3/16 -
Uploaded on

December 3, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00291005

English

Eligibility Prostatic Neoplasms NCT00291005

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.
Description

Gender | Adenocarcinoma of prostate | Metastatic Lesion Quantity | Measurable Disease | Hormone Therapy | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0007112
UMLS CUI [3,1]
C1513183
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C1513041
UMLS CUI [5]
C0279025
UMLS CUI [6]
C0242656
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1.body temperature > 38 degree centigrade.
Description

Body temperature measurement Degrees Celsius

Data type

boolean

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0439237
2.prior radiotherapy to > 25% of bone marrow.
Description

Therapeutic radiology procedure Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
3.prior isotope therapy and/or brachytherapy
Description

Radionuclide therapy | Brachytherapy

Data type

boolean

Alias
UMLS CUI [1]
C0203608
UMLS CUI [2]
C0006098
4.prior gene therapy.
Description

gene therapy

Data type

boolean

Alias
UMLS CUI [1]
C0017296
5.active double cancer.
Description

Malignant Neoplasm double

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205173
6.known brain or leptomeningeal involvement.
Description

Brain Involvement | Leptomeninges Involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C1314939
UMLS CUI [2,1]
C0228126
UMLS CUI [2,2]
C1314939
7.history of hypersensitivity reaction to drug
Description

Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0013182
8.other serious illness or medical condition
Description

Illness Serious | Medical condition Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
9.subjects whom the investigators consider inappropriate from social or medical aspects.
Description

Social Conditions Study Subject Participation Status Exclusion | Medical condition Study Subject Participation Status Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0037403
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C2828389
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Similar models

Eligibility Prostatic Neoplasms NCT00291005

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Adenocarcinoma of prostate | Metastatic Lesion Quantity | Measurable Disease | Hormone Therapy | Disease Progression
Item
men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.
boolean
C0079399 (UMLS CUI [1])
C0007112 (UMLS CUI [2])
C1513183 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C0242656 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Body temperature measurement Degrees Celsius
Item
1.body temperature > 38 degree centigrade.
boolean
C0886414 (UMLS CUI [1,1])
C0439237 (UMLS CUI [1,2])
Therapeutic radiology procedure Bone Marrow Percentage
Item
2.prior radiotherapy to > 25% of bone marrow.
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Radionuclide therapy | Brachytherapy
Item
3.prior isotope therapy and/or brachytherapy
boolean
C0203608 (UMLS CUI [1])
C0006098 (UMLS CUI [2])
gene therapy
Item
4.prior gene therapy.
boolean
C0017296 (UMLS CUI [1])
Malignant Neoplasm double
Item
5.active double cancer.
boolean
C0006826 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
Brain Involvement | Leptomeninges Involvement
Item
6.known brain or leptomeningeal involvement.
boolean
C0006104 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0228126 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
Drug Allergy
Item
7.history of hypersensitivity reaction to drug
boolean
C0013182 (UMLS CUI [1])
Illness Serious | Medical condition Serious
Item
8.other serious illness or medical condition
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Social Conditions Study Subject Participation Status Exclusion | Medical condition Study Subject Participation Status Exclusion
Item
9.subjects whom the investigators consider inappropriate from social or medical aspects.
boolean
C0037403 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
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