ID

22799

Description

Efficacy and Safety Study of Xyotax to Treat Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00446836

Link

https://clinicaltrials.gov/show/NCT00446836

Keywords

Versions (3)
  1. 6/12/17 6/12/17 -
  2. 6/12/17 6/12/17 -
  3. 6/13/17 6/13/17 -
Uploaded on

June 12, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Prostatic Neoplasms NCT00446836

English

Eligibility Prostatic Neoplasms NCT00446836

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
progressing adenocarcinoma of the prostate having failed prior hormone therapy
Description

Adenocarcinoma of prostate Progressive | Hormone Therapy failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0231175
free of serious co-morbidity
Description

Comorbidity Serious Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332296
have a life expectancy of ≥ 24 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
maintaining castrate status (either surgically or hormonally)
Description

Castration

Data type

boolean

Alias
UMLS CUI [1]
C0007344
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with central nervous system metastases, except those patients who have had excision or radiotherapy and remain asymptomatic, off steroids and with no evidence of disease as shown by mri for at least 6 months
Description

CNS metastases | Asymptomatic Due to Excision | Asymptomatic Due to Therapeutic radiology procedure | Steroids Absent | Disease Free MRI

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0231221
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0728940
UMLS CUI [3,1]
C0231221
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C1522449
UMLS CUI [4,1]
C0038317
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332296
UMLS CUI [5,3]
C0024485
patients known to be hiv positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
patients with active autoimmune disease
Description

Autoimmune Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004364
patients involving concurrent anticancer drug therapy
Description

Cancer pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
patients with unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable chf, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months)
Description

Medical condition Unstable | Diabetic - poor control | Uncontrolled hypertension | Communicable Diseases Requirement Antibiotics for systemic use | ANTIVIRALS FOR SYSTEMIC USE | ANTIFUNGALS FOR SYSTEMIC USE | Cardiac dysfunction | Pulmonary Dysfunction | Congestive heart failure Unstable | Cardiac Arrhythmia Uncontrolled | Blood Coagulation Disorders Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0421258
UMLS CUI [3]
C1868885
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C3540704
UMLS CUI [5]
C3653777
UMLS CUI [6]
C3653743
UMLS CUI [7]
C3277906
UMLS CUI [8]
C1709770
UMLS CUI [9,1]
C0018802
UMLS CUI [9,2]
C0443343
UMLS CUI [10,1]
C0003811
UMLS CUI [10,2]
C0205318
UMLS CUI [11,1]
C0005779
UMLS CUI [11,2]
C0443343
UMLS CUI [12]
C0027051
Back to the top of the page

Similar models

Eligibility Prostatic Neoplasms NCT00446836

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate Progressive | Hormone Therapy failed
Item
progressing adenocarcinoma of the prostate having failed prior hormone therapy
boolean
C0007112 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Comorbidity Serious Free of
Item
free of serious co-morbidity
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
Life Expectancy
Item
have a life expectancy of ≥ 24 weeks
boolean
C0023671 (UMLS CUI [1])
Castration
Item
maintaining castrate status (either surgically or hormonally)
boolean
C0007344 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases | Asymptomatic Due to Excision | Asymptomatic Due to Therapeutic radiology procedure | Steroids Absent | Disease Free MRI
Item
patients with central nervous system metastases, except those patients who have had excision or radiotherapy and remain asymptomatic, off steroids and with no evidence of disease as shown by mri for at least 6 months
boolean
C0686377 (UMLS CUI [1])
C0231221 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
C0231221 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C0038317 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
HIV Seropositivity
Item
patients known to be hiv positive
boolean
C0019699 (UMLS CUI [1])
Autoimmune Diseases
Item
patients with active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Cancer pharmacotherapy
Item
patients involving concurrent anticancer drug therapy
boolean
C0392920 (UMLS CUI [1])
Medical condition Unstable | Diabetic - poor control | Uncontrolled hypertension | Communicable Diseases Requirement Antibiotics for systemic use | ANTIVIRALS FOR SYSTEMIC USE | ANTIFUNGALS FOR SYSTEMIC USE | Cardiac dysfunction | Pulmonary Dysfunction | Congestive heart failure Unstable | Cardiac Arrhythmia Uncontrolled | Blood Coagulation Disorders Unstable | Myocardial Infarction
Item
patients with unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable chf, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months)
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C3540704 (UMLS CUI [4,3])
C3653777 (UMLS CUI [5])
C3653743 (UMLS CUI [6])
C3277906 (UMLS CUI [7])
C1709770 (UMLS CUI [8])
C0018802 (UMLS CUI [9,1])
C0443343 (UMLS CUI [9,2])
C0003811 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
C0005779 (UMLS CUI [11,1])
C0443343 (UMLS CUI [11,2])
C0027051 (UMLS CUI [12])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial