0 Evaluaciones
ID

22710

Descripción

Prospective Randomized Trial of Seminal Vesicle-Sparing Prostatectomy and Nerve-Sparing Radical Prostatectomy in Men With Clinically Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01825642

Link

https://clinicaltrials.gov/show/NCT01825642

Palabras clave

Versiones (1)
  1. 10/6/17 10/6/17 -
Subido en

10 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Prostate Cancer NCT01825642

    Inglés

    Eligibility Prostate Cancer NCT01825642

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    men with biopsy-proven histologic diagnosis of prostate adenocarcinoma
    Descripción

    gender, histologically confirmed adenocarcinoma of the prostate

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2,1]
    C0679557
    UMLS CUI [2,2]
    C0007112
    low risk for seminal vesicle invasions defined by:
    Descripción

    low risk for seminal vesicle invasions

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3538919
    UMLS CUI [1,2]
    C1718327
    clinical stage t1c/tumor 2-node 0-metastasis 0, gleason score ≤ 6, psa ≤ 10 ng/ml, positive prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage t1c/t2n0m0, gleason ≤ 7, psa ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%)
    Descripción

    clinical TNM stage, gleason, psa, positive prostate biopsy core proportion

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1707417
    UMLS CUI [2]
    C3203027
    UMLS CUI [3]
    C0201544
    UMLS CUI [4,1]
    C0194804
    UMLS CUI [4,2]
    C1446409
    UMLS CUI [4,3]
    C0444669
    UMLS CUI [4,4]
    C1709707
    sexually potent, defined as international index of erectile function score ≥ 21, prior to randomization and surgery
    Descripción

    international index of erectile function score

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2959364
    competent to provide informed consent
    Descripción

    informed consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    able to read and write english
    Descripción

    english

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0376245
    candidate for bilateral nerve-sparing
    Descripción

    bilateral nerve-sparing

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0444743
    willing to be followed for 12 months post-surgery
    Descripción

    compliance follow-up

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C1522577
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    intermediate or high risk for seminal vesicle invasion
    Descripción

    intermediate or high risk for seminal vesicle invasion

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3640764
    UMLS CUI [1,2]
    C0332167
    UMLS CUI [1,3]
    C1718327
    unwilling to be randomized to either treatment arm
    Descripción

    unwilling to be randomized

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0558080
    UMLS CUI [1,2]
    C0034656
    pre-operative treatment with radiation and/or hormone therapy
    Descripción

    pre-operative treatment with radiation and/or hormone therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0279134
    UMLS CUI [2]
    C1514460
    planned adjuvant radiation and/or hormonal therapy
    Descripción

    planned adjuvant radiation and/or hormonal therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1301732
    UMLS CUI [1,2]
    C1706721
    UMLS CUI [2,1]
    C1301732
    UMLS CUI [2,2]
    C1971498
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    Similar models

    Eligibility Prostate Cancer NCT01825642

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    gender, histologically confirmed adenocarcinoma of the prostate
    Item
    men with biopsy-proven histologic diagnosis of prostate adenocarcinoma
    boolean
    C0079399 (UMLS CUI [1])
    C0679557 (UMLS CUI [2,1])
    C0007112 (UMLS CUI [2,2])
    low risk for seminal vesicle invasions
    Item
    low risk for seminal vesicle invasions defined by:
    boolean
    C3538919 (UMLS CUI [1,1])
    C1718327 (UMLS CUI [1,2])
    clinical TNM stage, gleason, psa, positive prostate biopsy core proportion
    Item
    clinical stage t1c/tumor 2-node 0-metastasis 0, gleason score ≤ 6, psa ≤ 10 ng/ml, positive prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage t1c/t2n0m0, gleason ≤ 7, psa ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%)
    boolean
    C1707417 (UMLS CUI [1])
    C3203027 (UMLS CUI [2])
    C0201544 (UMLS CUI [3])
    C0194804 (UMLS CUI [4,1])
    C1446409 (UMLS CUI [4,2])
    C0444669 (UMLS CUI [4,3])
    C1709707 (UMLS CUI [4,4])
    international index of erectile function score
    Item
    sexually potent, defined as international index of erectile function score ≥ 21, prior to randomization and surgery
    boolean
    C2959364 (UMLS CUI [1])
    informed consent
    Item
    competent to provide informed consent
    boolean
    C0021430 (UMLS CUI [1])
    english
    Item
    able to read and write english
    boolean
    C0376245 (UMLS CUI [1])
    bilateral nerve-sparing
    Item
    candidate for bilateral nerve-sparing
    boolean
    C0444743 (UMLS CUI [1])
    compliance follow-up
    Item
    willing to be followed for 12 months post-surgery
    boolean
    C1321605 (UMLS CUI [1,1])
    C1522577 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    intermediate or high risk for seminal vesicle invasion
    Item
    intermediate or high risk for seminal vesicle invasion
    boolean
    C3640764 (UMLS CUI [1,1])
    C0332167 (UMLS CUI [1,2])
    C1718327 (UMLS CUI [1,3])
    unwilling to be randomized
    Item
    unwilling to be randomized to either treatment arm
    boolean
    C0558080 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    pre-operative treatment with radiation and/or hormone therapy
    Item
    pre-operative treatment with radiation and/or hormone therapy
    boolean
    C0279134 (UMLS CUI [1])
    C1514460 (UMLS CUI [2])
    planned adjuvant radiation and/or hormonal therapy
    Item
    planned adjuvant radiation and/or hormonal therapy
    boolean
    C1301732 (UMLS CUI [1,1])
    C1706721 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [2,1])
    C1971498 (UMLS CUI [2,2])
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