ID

18980

Description

Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00127088

Link

https://clinicaltrials.gov/show/NCT00127088

Keywords

Versions (1)
  1. 11/28/16 11/28/16 -
Uploaded on

November 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00127088

English

Eligibility Prostate Cancer NCT00127088

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients older than 18 years and less than 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically-proven gleason 7 adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate Gleason score

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3203027
pt2a or pt2b disease based on biopsies of the prostate
Description

TNM clinical staging Biopsy of prostate

Data type

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0194804
more than 2/3 of positive biopsies or 15 ≤ serum psa <20
Description

Prostate specific antigen measurement Biopsy Positive Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C1265611
no previous carcinoma, except basal-cell carcinoma of the skin
Description

Carcinoma | Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007097
UMLS CUI [2]
C0007117
adequate renal function: measured or calculated creatinine clearance> 60 ml/min
Description

Renal function | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0373595
UMLS CUI [3]
C2711451
absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
Description

Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1278039
signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients infected by the human immunodeficiency virus (hiv)
Description

HIV Infections

Data type

boolean

Alias
UMLS CUI [1]
C0019693
contra-indication to general anesthesia or surgery
Description

Medical contraindication General Anesthesia | Medical contraindication Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002915
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0543467
patients who do not fit inclusion criteria
Description

Inclusion criteria Mismatch

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1881865
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Similar models

Eligibility Prostate Cancer NCT00127088

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients older than 18 years and less than 70 years
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate Gleason score
Item
histologically-proven gleason 7 adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
TNM clinical staging Biopsy of prostate
Item
pt2a or pt2b disease based on biopsies of the prostate
boolean
C3258246 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
Prostate specific antigen measurement Biopsy Positive Quantity
Item
more than 2/3 of positive biopsies or 15 ≤ serum psa <20
boolean
C0201544 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Carcinoma | Basal cell carcinoma
Item
no previous carcinoma, except basal-cell carcinoma of the skin
boolean
C0007097 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
Renal function | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
adequate renal function: measured or calculated creatinine clearance> 60 ml/min
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement
Item
absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Informed Consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Infections
Item
patients infected by the human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
Medical contraindication General Anesthesia | Medical contraindication Operative Surgical Procedures
Item
contra-indication to general anesthesia or surgery
boolean
C1301624 (UMLS CUI [1,1])
C0002915 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Inclusion criteria Mismatch
Item
patients who do not fit inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C1881865 (UMLS CUI [1,2])
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