ID

31618

Descrição

Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00868868

Link

https://clinicaltrials.gov/show/NCT00868868

Palavras-chave

Versões (1)
  1. 12/09/2018 12/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00868868

Inglês

Eligibility Prostate Cancer NCT00868868

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
histologically proven prostate cancer
Descrição

Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0600139
treatment plan is to administer long term adt (androgen deprivation therapy).
Descrição

Treatment Plan Antiandrogen therapy Long-term

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0599880
UMLS CUI [1,2]
C0279492
UMLS CUI [1,3]
C0443252
patient must currently be treated with adt for at least 2 weeks before enrollment in trial, and for no more than 6 months. patient treated with a maximum androgen blockade strategy, combining an anti-androgen agent with a lhrh analog agent are admissible to this protocol, but not patients treated only with an anti-androgen agent alone.
Descrição

Antiandrogen therapy | Combined Modality Therapy | Androgen Antagonists | LHRH Analogs | Androgen Antagonists Alone Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0002842
UMLS CUI [4]
C1518041
UMLS CUI [5,1]
C0002842
UMLS CUI [5,2]
C0205171
UMLS CUI [5,3]
C0332196
written informed consent to participate in the trial.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to zoladex, casodex (if applicable), or any component of these product, or to other similar agents
Descrição

Hypersensitivity Zoladex | Hypersensitivity Casodex | Hypersensitivity Zoladex Component | Hypersensitivity Casodex Component | Hypersensitivity Pharmaceutical Preparations Similar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0149473
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0591237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0149473
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0591237
UMLS CUI [4,3]
C1705248
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C2348205
severe cardiac disease (new york heart association class iii or greater)
Descrição

Heart Disease Severe New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
severe lung disease
Descrição

Lung disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
uncontrollable pain
Descrição

Uncontrolled pain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0747149
unstable bone lesion
Descrição

Bone lesion Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0238792
UMLS CUI [1,2]
C0443343
any co-morbidity restraining the patient's ability to walk alone or to modify his walking habits (eg parkinson's disease, advanced multiple sclerosis, leg amputation, ...)
Descrição

Comorbidity Difficulty walking | Modification Walking habits Limited | Parkinson Disease | Multiple Sclerosis Advanced | Amputation of lower limb

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0311394
UMLS CUI [2,1]
C3840684
UMLS CUI [2,2]
C0080331
UMLS CUI [2,3]
C2242848
UMLS CUI [2,4]
C0439801
UMLS CUI [3]
C0030567
UMLS CUI [4,1]
C0026769
UMLS CUI [4,2]
C0205179
UMLS CUI [5]
C0337308
any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
Descrição

Comorbidity Study Subject Participation Status Unfavorable | Comorbidity compromises Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
any contraindication to undertake the 6-minutes walk test (unstable angina or myocardial infarction during the previous month, a resting heart rate of more than 180, systolic blood pressure of more than 180, and a diastolic pressure of more than 100). the patient must have his cardiovascular conditions stabilized and controlled before enrollment in the trial.
Descrição

Medical contraindication 6-Minute Walk Test | Angina, Unstable | Myocardial Infarction | Resting heart rate | Increased systolic pressure | Increased diastolic pressure | Cardiovascular conditions Stabilized Controlled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0430515
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C1821417
UMLS CUI [5]
C0277884
UMLS CUI [6]
C0277889
UMLS CUI [7,1]
C2015790
UMLS CUI [7,2]
C0184512
UMLS CUI [7,3]
C2911690
unwillingness or incapacity to consent to trial participation.
Descrição

Informed Consent Unwilling | Informed Consent Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Prostate Cancer NCT00868868

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Prostate carcinoma
Item
histologically proven prostate cancer
boolean
C0600139 (UMLS CUI [1])
Treatment Plan Antiandrogen therapy Long-term
Item
treatment plan is to administer long term adt (androgen deprivation therapy).
boolean
C0599880 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Antiandrogen therapy | Combined Modality Therapy | Androgen Antagonists | LHRH Analogs | Androgen Antagonists Alone Excluded
Item
patient must currently be treated with adt for at least 2 weeks before enrollment in trial, and for no more than 6 months. patient treated with a maximum androgen blockade strategy, combining an anti-androgen agent with a lhrh analog agent are admissible to this protocol, but not patients treated only with an anti-androgen agent alone.
boolean
C0279492 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0002842 (UMLS CUI [3])
C1518041 (UMLS CUI [4])
C0002842 (UMLS CUI [5,1])
C0205171 (UMLS CUI [5,2])
C0332196 (UMLS CUI [5,3])
Informed Consent
Item
written informed consent to participate in the trial.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Zoladex | Hypersensitivity Casodex | Hypersensitivity Zoladex Component | Hypersensitivity Casodex Component | Hypersensitivity Pharmaceutical Preparations Similar
Item
known hypersensitivity to zoladex, casodex (if applicable), or any component of these product, or to other similar agents
boolean
C0020517 (UMLS CUI [1,1])
C0149473 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0591237 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0149473 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0591237 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C2348205 (UMLS CUI [5,3])
Heart Disease Severe New York Heart Association Classification
Item
severe cardiac disease (new york heart association class iii or greater)
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Lung disease Severe
Item
severe lung disease
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Uncontrolled pain
Item
uncontrollable pain
boolean
C0747149 (UMLS CUI [1])
Bone lesion Unstable
Item
unstable bone lesion
boolean
C0238792 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Comorbidity Difficulty walking | Modification Walking habits Limited | Parkinson Disease | Multiple Sclerosis Advanced | Amputation of lower limb
Item
any co-morbidity restraining the patient's ability to walk alone or to modify his walking habits (eg parkinson's disease, advanced multiple sclerosis, leg amputation, ...)
boolean
C0009488 (UMLS CUI [1,1])
C0311394 (UMLS CUI [1,2])
C3840684 (UMLS CUI [2,1])
C0080331 (UMLS CUI [2,2])
C2242848 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C0030567 (UMLS CUI [3])
C0026769 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C0337308 (UMLS CUI [5])
Comorbidity Study Subject Participation Status Unfavorable | Comorbidity compromises Protocol Compliance
Item
any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Medical contraindication 6-Minute Walk Test | Angina, Unstable | Myocardial Infarction | Resting heart rate | Increased systolic pressure | Increased diastolic pressure | Cardiovascular conditions Stabilized Controlled
Item
any contraindication to undertake the 6-minutes walk test (unstable angina or myocardial infarction during the previous month, a resting heart rate of more than 180, systolic blood pressure of more than 180, and a diastolic pressure of more than 100). the patient must have his cardiovascular conditions stabilized and controlled before enrollment in the trial.
boolean
C1301624 (UMLS CUI [1,1])
C0430515 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C1821417 (UMLS CUI [4])
C0277884 (UMLS CUI [5])
C0277889 (UMLS CUI [6])
C2015790 (UMLS CUI [7,1])
C0184512 (UMLS CUI [7,2])
C2911690 (UMLS CUI [7,3])
Informed Consent Unwilling | Informed Consent Unable
Item
unwillingness or incapacity to consent to trial participation.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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