ID

31602

Descrição

Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00833248

Link

https://clinicaltrials.gov/show/NCT00833248

Palavras-chave

Versões (1)
  1. 11/09/2018 11/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00833248

Inglês

Eligibility Prostate Cancer NCT00833248

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has given written informed consent before any trial-related activity is performed.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
has a confirmed prostate cancer in which this type of treatment is needed.
Descrição

Prostate carcinoma | Therapeutic procedure Type Required

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332307
UMLS CUI [2,3]
C1514873
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment for prostate cancer
Descrição

Prior Therapy Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0600139
previous trans-urethral resection of the prostate
Descrição

Transurethral Resection of Prostate Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040771
UMLS CUI [1,2]
C0205156
patients who are lymph node positive or have other metastatic disease
Descrição

Lymph node positive | Neoplasm Metastasis Other

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0746319
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0205394
use of urethral catheter
Descrição

Use of Urethral Catheter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0179800
current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
Descrição

5-alpha Reductase Inhibitors | Alpha-Adrenergic Receptor antagonist

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2936788
UMLS CUI [2,1]
C2932393
UMLS CUI [2,2]
C0243076
history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Descrição

Severe asthma untreated | Anaphylaxis | Urticaria Severe | Angioedema

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0581126
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0002792
UMLS CUI [3,1]
C0042109
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0002994
hypersensitivity towards any component of the investigational product
Descrição

Hypersensitivity Investigational New Drug Component

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
Descrição

Cancer Other | Exception Prostate carcinoma | Exception Skin carcinoma Type Some

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C0332307
UMLS CUI [3,4]
C0205392
certain risk factors for abnormal heart rhythms/qt prolongation (corrected qt interval over 450 msec., torsades de pointes or use of certain medications with potential risk)
Descrição

Risk factors Cardiac Arrhythmia | Risk factors Prolonged QT interval | Prolonged QTc | Torsades de Pointes | Medication Risk

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0003811
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0151878
UMLS CUI [3]
C1969409
UMLS CUI [4]
C0040479
UMLS CUI [5]
C0184544
clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Descrição

Disease | Exception Prostate carcinoma | Kidney Diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Heart Diseases | Nervous system disorder | Mental disorders | Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600139
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0018799
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0004936
UMLS CUI [10]
C0038586
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Similar models

Eligibility Prostate Cancer NCT00833248

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patient has given written informed consent before any trial-related activity is performed.
boolean
C0021430 (UMLS CUI [1])
Prostate carcinoma | Therapeutic procedure Type Required
Item
has a confirmed prostate cancer in which this type of treatment is needed.
boolean
C0600139 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Prostate carcinoma
Item
previous treatment for prostate cancer
boolean
C1514463 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Transurethral Resection of Prostate Previous
Item
previous trans-urethral resection of the prostate
boolean
C0040771 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Lymph node positive | Neoplasm Metastasis Other
Item
patients who are lymph node positive or have other metastatic disease
boolean
C0746319 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Use of Urethral Catheter
Item
use of urethral catheter
boolean
C1524063 (UMLS CUI [1,1])
C0179800 (UMLS CUI [1,2])
5-alpha Reductase Inhibitors | Alpha-Adrenergic Receptor antagonist
Item
current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
boolean
C2936788 (UMLS CUI [1])
C2932393 (UMLS CUI [2,1])
C0243076 (UMLS CUI [2,2])
Severe asthma untreated | Anaphylaxis | Urticaria Severe | Angioedema
Item
history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
boolean
C0581126 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2])
C0042109 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002994 (UMLS CUI [4])
Hypersensitivity Investigational New Drug Component
Item
hypersensitivity towards any component of the investigational product
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Cancer Other | Exception Prostate carcinoma | Exception Skin carcinoma Type Some
Item
other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C0332307 (UMLS CUI [3,3])
C0205392 (UMLS CUI [3,4])
Risk factors Cardiac Arrhythmia | Risk factors Prolonged QT interval | Prolonged QTc | Torsades de Pointes | Medication Risk
Item
certain risk factors for abnormal heart rhythms/qt prolongation (corrected qt interval over 450 msec., torsades de pointes or use of certain medications with potential risk)
boolean
C0035648 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0151878 (UMLS CUI [2,2])
C1969409 (UMLS CUI [3])
C0040479 (UMLS CUI [4])
C0184544 (UMLS CUI [5])
Disease | Exception Prostate carcinoma | Kidney Diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Heart Diseases | Nervous system disorder | Mental disorders | Substance Use Disorders
Item
clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
boolean
C0012634 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0018799 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0038586 (UMLS CUI [10])
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