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ID

43782

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00344825

Keywords

versioni (2)
  1. 07/10/16 07/10/16 -
  2. 20/09/21 20/09/21 -
Caricato su

20 settembre 2021

DOI

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Licenza

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

    Inglese

    Eligibility Leukemia, B-Cell, Chronic NCT00344825

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    aged >/=18 years
    Descrizione

    Age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    patients of either sex with b-cll, who are starting a new pharmacological treatment for b-chronic lymphocytic leukemia (1st, 2nd, 3rd, 4th)
    Descrizione

    Gender | Chronic Lymphocytic Leukemia | Pharmacotherapy New Chronic Lymphocytic Leukemia

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    UMLS CUI [3,1]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    UMLS CUI [3,2]
    C0205314 (New)
    SNOMED
    7147002
    LOINC
    LA9039-4
    UMLS CUI [3,3]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    foreseen duration of cll therapy </= 6 months
    Descrizione

    Duration of therapy Chronic Lymphocytic Leukemia

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0444921 (Duration of treatment)
    SNOMED
    261773006
    UMLS CUI [1,2]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    b-chronic lymphocytic leukemia progressive stage a, stage b or c (according to binet system), or ii-iv (according to rai system)
    Descrizione

    Chronic Lymphocytic Leukemia | Binet Staging System | Rai Staging System

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    UMLS CUI [2]
    C1511118 (Binet Staging System)
    UMLS CUI [3]
    C1514715 (Rai Staging System)
    who performance status </= 2
    Descrizione

    WHO performance status scale

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1298650 (WHO performance status scale)
    SNOMED
    373801008
    life expectancy </= 6 months
    Descrizione

    Life Expectancy

    Tipo di dati

    boolean

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

    Informed Consent | Quality of life scale

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    UMLS CUI [2]
    C0451401 (Quality of life scale)
    SNOMED
    273725009
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients with any other tumour disease
    Descrizione

    Malignant Neoplasms

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    chronic lymphocytic leukemia therapy in the last 30 days before v0
    Descrizione

    Therapeutic procedure Chronic Lymphocytic Leukemia

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    more than 3 previous cll treatments (the therapy is defined by the drug and/or the treatment period)
    Descrizione

    Therapeutic procedure Quantity Chronic Lymphocytic Leukemia

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [1,3]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    previous stem cells transplantation
    Descrizione

    Stem cell transplant

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1504389 (Stem cell transplant)
    concurrent or in the last 30 days participation to any other clinical trial
    Descrizione

    Study Subject Participation Status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    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
    Descrizione

    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 di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [2,1]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [2,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [2,3]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [2,4]
    C0451401 (Quality of life scale)
    SNOMED
    273725009
    UMLS CUI [3,1]
    C3840291 (Mental condition)
    LOINC
    MTHU047984
    UMLS CUI [3,2]
    C0021430 (Informed Consent)
    UMLS CUI [3,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [4,1]
    C3840291 (Mental condition)
    LOINC
    MTHU047984
    UMLS CUI [4,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [4,3]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [4,4]
    C0451401 (Quality of life scale)
    SNOMED
    273725009
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    Similar models

    Eligibility Leukemia, B-Cell, Chronic NCT00344825

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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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