ID

101

Descripción

ODM derived from http://clinicaltrials.gov/ct2/show/study/NCT00626548?term=NCT00626548

Link

http://clinicaltrials.gov/ct2/show/study/NCT00626548?term=NCT00626548

Palabras clave

Versiones (5)
  1. 22/11/11 22/11/11 -
  2. 22/11/11 22/11/11 -
  3. 27/3/14 27/3/14 - Martin Dugas
  4. 13/4/14 13/4/14 - Julian Varghese
  5. 17/9/21 17/9/21 -
Subido en

22 de noviembre de 2011

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)

Inglés

Eligibility

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Descripción

Inclusion criteria

18 Years and older
Descripción

Age

Tipo de datos

boolean

Male
Descripción

Gender

Tipo de datos

boolean

Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
Descripción

Prostate Cancer

Tipo de datos

boolean

Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
Descripción

PSA

Tipo de datos

boolean

Currently receiving treatment with surgical or medical castration
Descripción

Castration

Tipo de datos

boolean

Exclusion criteria
Descripción

Exclusion criteria

Currently using opiate based pain killers for cancer related pain
Descripción

Opiate

Tipo de datos

boolean

Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
Descripción

Previous chemotherapy

Tipo de datos

boolean

Suffering from heart failure or had a myocardial infarction within last 6 months
Descripción

Heart disease

Tipo de datos

boolean

A history of epilepsy or seizures
Descripción

Epilepsy

Tipo de datos

boolean

Medical concepts
Descripción

Medical concepts

Age
Descripción

Age

Tipo de datos

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Gender
Descripción

Gender

Tipo de datos

string

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LOINC Version 232
MTHU002975
Diagnosis
Descripción

Diagnosis

Tipo de datos

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Prostate carcinoma
Descripción

Cancer of prostate

Tipo de datos

string

Alias
UMLS CUI
C0600139
SNOMED CT 2010_0731
254900004
MedDRA 13.1
10036921
Metastasis
Descripción

Metastasis

Tipo de datos

string

Alias
UMLS CUI
C0027627
SNOMED CT 2010_0731
128462008
MedDRA 13.1
10027449
Prostate-Specific Antigen
Descripción

PSA

Tipo de datos

string

Alias
UMLS CUI
C0138741
SNOMED CT 2010_0731
102687007
LOINC Version 232
MTHU001466
Castration
Descripción

Castration

Tipo de datos

string

Alias
UMLS CUI
C0007347
SNOMED CT 2010_0731
275234001
Medication
Descripción

Pharmaceutical Preparations

Tipo de datos

string

Alias
UMLS CUI
C0013227
Opiates
Descripción

Opiate

Tipo de datos

string

Alias
UMLS CUI
C0376196
SNOMED CT 2010_0731
360204007
LOINC Version 232
MTHU001585
Pain
Descripción

Pain

Tipo de datos

string

Alias
UMLS CUI
C0030193
SNOMED CT 2010_0731
22253000
MedDRA 13.1
10033371
LOINC Version 232
MTHU029813
ICD-10-CM Version 2010
R52
ICD-9-CM Version 2011
338-338.9
CTCAE Version 4.03
E11167
Chemotherapy
Descripción

Chemotherapy

Tipo de datos

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Heart failure
Descripción

Heart failure

Tipo de datos

string

Alias
UMLS CUI
C0018801
SNOMED CT 2010_0731
155374007
MedDRA 13.1
10019279
Acute myocardial infarction
Descripción

Acute myocardial infarction

Tipo de datos

string

Alias
UMLS CUI
C0155626
SNOMED CT 2010_0731
57054005
MedDRA 13.1
10000891
ICD-10-CM Version 2010
I21
ICD-9-CM Version 2011
410
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Similar models

Eligibility

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion criteria
Age
Item
18 Years and older
boolean
Gender
Item
Male
boolean
Prostate Cancer
Item
Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
boolean
PSA
Item
Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
boolean
Castration
Item
Currently receiving treatment with surgical or medical castration
boolean
Item Group
Exclusion criteria
Opiate
Item
Currently using opiate based pain killers for cancer related pain
boolean
Previous chemotherapy
Item
Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
boolean
Heart disease
Item
Suffering from heart failure or had a myocardial infarction within last 6 months
boolean
Epilepsy
Item
A history of epilepsy or seizures
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Gender
Item
Gender
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LOINC Version 232)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Cancer of prostate
Item
Prostate carcinoma
string
C0600139 (UMLS CUI)
254900004 (SNOMED CT 2010_0731)
10036921 (MedDRA 13.1)
Metastasis
Item
Metastasis
string
C0027627 (UMLS CUI)
128462008 (SNOMED CT 2010_0731)
10027449 (MedDRA 13.1)
PSA
Item
Prostate-Specific Antigen
string
C0138741 (UMLS CUI)
102687007 (SNOMED CT 2010_0731)
MTHU001466 (LOINC Version 232)
Castration
Item
Castration
string
C0007347 (UMLS CUI)
275234001 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Opiate
Item
Opiates
string
C0376196 (UMLS CUI)
360204007 (SNOMED CT 2010_0731)
MTHU001585 (LOINC Version 232)
Pain
Item
Pain
string
C0030193 (UMLS CUI)
22253000 (SNOMED CT 2010_0731)
10033371 (MedDRA 13.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE Version 4.03)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Heart failure
Item
Heart failure
string
C0018801 (UMLS CUI)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
Acute myocardial infarction
Item
Acute myocardial infarction
string
C0155626 (UMLS CUI)
57054005 (SNOMED CT 2010_0731)
10000891 (MedDRA 13.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
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