0 Avaliações
ID

43782

Descrição

Vitalis Study - Observational Study on the Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia (B-CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00344825

Link

https://clinicaltrials.gov/show/NCT00344825

Palavras-chave

Versões (2)
  1. 07/10/2016 07/10/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Leukemia, B-Cell, Chronic NCT00344825

    Inglês

    Eligibility Leukemia, B-Cell, Chronic NCT00344825

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    aged >/=18 years
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients of either sex with b-cll, who are starting a new pharmacological treatment for b-chronic lymphocytic leukemia (1st, 2nd, 3rd, 4th)
    Descrição

    Gender | Chronic Lymphocytic Leukemia | Pharmacotherapy New Chronic Lymphocytic Leukemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0023434
    UMLS CUI [3,1]
    C0013216
    UMLS CUI [3,2]
    C0205314
    UMLS CUI [3,3]
    C0023434
    foreseen duration of cll therapy </= 6 months
    Descrição

    Duration of therapy Chronic Lymphocytic Leukemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0444921
    UMLS CUI [1,2]
    C0023434
    b-chronic lymphocytic leukemia progressive stage a, stage b or c (according to binet system), or ii-iv (according to rai system)
    Descrição

    Chronic Lymphocytic Leukemia | Binet Staging System | Rai Staging System

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    UMLS CUI [2]
    C1511118
    UMLS CUI [3]
    C1514715
    who performance status </= 2
    Descrição

    WHO performance status scale

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    life expectancy </= 6 months
    Descrição

    Life Expectancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    signed informed consent for personal data's treatment and availability to fill in the qol questionnaire
    Descrição

    Informed Consent | Quality of life scale

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0451401
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with any other tumour disease
    Descrição

    Malignant Neoplasms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    chronic lymphocytic leukemia therapy in the last 30 days before v0
    Descrição

    Therapeutic procedure Chronic Lymphocytic Leukemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0023434
    more than 3 previous cll treatments (the therapy is defined by the drug and/or the treatment period)
    Descrição

    Therapeutic procedure Quantity Chronic Lymphocytic Leukemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0023434
    previous stem cells transplantation
    Descrição

    Stem cell transplant

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1504389
    concurrent or in the last 30 days participation to any other clinical trial
    Descrição

    Study Subject Participation Status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    any medical or psychological conditions that might compromise the capacity to sign the consent for personal data's treatment or to fill in the qol questionnaire
    Descrição

    medical condition Informed Consent Limited | medical condition Affecting Completion Quality of life scale | Mental condition Informed Consent Limited | Mental condition Affecting Completion Quality of life scale

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0439801
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0205197
    UMLS CUI [2,4]
    C0451401
    UMLS CUI [3,1]
    C3840291
    UMLS CUI [3,2]
    C0021430
    UMLS CUI [3,3]
    C0439801
    UMLS CUI [4,1]
    C3840291
    UMLS CUI [4,2]
    C0392760
    UMLS CUI [4,3]
    C0205197
    UMLS CUI [4,4]
    C0451401
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    Similar models

    Eligibility Leukemia, B-Cell, Chronic NCT00344825

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    aged >/=18 years
    boolean
    C0001779 (UMLS CUI [1])
    Gender | Chronic Lymphocytic Leukemia | Pharmacotherapy New Chronic Lymphocytic Leukemia
    Item
    patients of either sex with b-cll, who are starting a new pharmacological treatment for b-chronic lymphocytic leukemia (1st, 2nd, 3rd, 4th)
    boolean
    C0079399 (UMLS CUI [1])
    C0023434 (UMLS CUI [2])
    C0013216 (UMLS CUI [3,1])
    C0205314 (UMLS CUI [3,2])
    C0023434 (UMLS CUI [3,3])
    Duration of therapy Chronic Lymphocytic Leukemia
    Item
    foreseen duration of cll therapy </= 6 months
    boolean
    C0444921 (UMLS CUI [1,1])
    C0023434 (UMLS CUI [1,2])
    Chronic Lymphocytic Leukemia | Binet Staging System | Rai Staging System
    Item
    b-chronic lymphocytic leukemia progressive stage a, stage b or c (according to binet system), or ii-iv (according to rai system)
    boolean
    C0023434 (UMLS CUI [1])
    C1511118 (UMLS CUI [2])
    C1514715 (UMLS CUI [3])
    WHO performance status scale
    Item
    who performance status </= 2
    boolean
    C1298650 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy </= 6 months
    boolean
    C0023671 (UMLS CUI [1])
    Informed Consent | Quality of life scale
    Item
    signed informed consent for personal data's treatment and availability to fill in the qol questionnaire
    boolean
    C0021430 (UMLS CUI [1])
    C0451401 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Malignant Neoplasms
    Item
    patients with any other tumour disease
    boolean
    C0006826 (UMLS CUI [1])
    Therapeutic procedure Chronic Lymphocytic Leukemia
    Item
    chronic lymphocytic leukemia therapy in the last 30 days before v0
    boolean
    C0087111 (UMLS CUI [1,1])
    C0023434 (UMLS CUI [1,2])
    Therapeutic procedure Quantity Chronic Lymphocytic Leukemia
    Item
    more than 3 previous cll treatments (the therapy is defined by the drug and/or the treatment period)
    boolean
    C0087111 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0023434 (UMLS CUI [1,3])
    Stem cell transplant
    Item
    previous stem cells transplantation
    boolean
    C1504389 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    concurrent or in the last 30 days participation to any other clinical trial
    boolean
    C2348568 (UMLS CUI [1])
    medical condition Informed Consent Limited | medical condition Affecting Completion Quality of life scale | Mental condition Informed Consent Limited | Mental condition Affecting Completion Quality of life scale
    Item
    any medical or psychological conditions that might compromise the capacity to sign the consent for personal data's treatment or to fill in the qol questionnaire
    boolean
    C3843040 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    C3843040 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0205197 (UMLS CUI [2,3])
    C0451401 (UMLS CUI [2,4])
    C3840291 (UMLS CUI [3,1])
    C0021430 (UMLS CUI [3,2])
    C0439801 (UMLS CUI [3,3])
    C3840291 (UMLS CUI [4,1])
    C0392760 (UMLS CUI [4,2])
    C0205197 (UMLS CUI [4,3])
    C0451401 (UMLS CUI [4,4])
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