ID

22876

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00446836

Trefwoorden

Versies (3)
  1. 12-06-17 12-06-17 -
  2. 12-06-17 12-06-17 -
  3. 13-06-17 13-06-17 -
Geüploaded op

13 juni 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00446836

Engels

Eligibility Prostatic Neoplasms NCT00446836

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Adenocarcinoma of prostate Progressive | Hormone Therapy failed

Datatype

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
Beschrijving

Comorbidity Serious Free of

Datatype

boolean

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

Life Expectancy

Datatype

boolean

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

Castration | Testosterone measurement Castration Level

Datatype

boolean

Alias
UMLS CUI [1]
C0007344
UMLS CUI [2,1]
C0523912
UMLS CUI [2,2]
C0007344
UMLS CUI [2,3]
C0441889
Exclusion Criteria
Beschrijving

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
Beschrijving

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

Datatype

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
Beschrijving

HIV Seropositivity

Datatype

boolean

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

Autoimmune Diseases

Datatype

boolean

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

Cancer pharmacotherapy

Datatype

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)
Beschrijving

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

Datatype

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
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Similar models

Eligibility Prostatic Neoplasms NCT00446836

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 | Testosterone measurement Castration Level
Item
maintaining castrate status (either surgically or hormonally)
boolean
C0007344 (UMLS CUI [1])
C0523912 (UMLS CUI [2,1])
C0007344 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
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])
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