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ID

14821

Description

Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01625286

Lien

https://clinicaltrials.gov/show/NCT01625286

Mots-clés

  1. 29/04/2016 29/04/2016 -
Téléchargé le

29 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility Advanced or Metastatic Breast Cancer, NCT01625286

    Eligibility Advanced or Metastatic Breast Cancer, NCT01625286

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    provision of informed consent
    Description

    informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    female patient
    Description

    female patient

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0150905 (patient is female)
    aged at least 18 years
    Description

    age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    histological or cytological confirmation of breast cancer with evidence of advanced or metastatic disease (must be er+ve, her2-ve, in part b).
    Description

    breast cancer

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0678222 (Breast Carcinoma)
    SNOMED
    254838004
    world health organisation (who) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
    Description

    who performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1298650 (WHO performance status scale)
    SNOMED
    373801008
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    clinically significant abnormalities of glucose metabolism
    Description

    clinically significant abnormalities of glucose metabolism

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0744434 (Alteration in glucose metabolism)
    spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
    Description

    spinal cord compression

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0037926 (Compression of spinal cord)
    SNOMED
    71286001
    UMLS CUI [2]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis b, c and hiv.
    Description

    systemic diseases, bleeding diatheses

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1536063 (Coagulopathies and bleeding diatheses (excl thrombocytopenic))
    UMLS CUI [2]
    C0442893 (Systemic disease)
    SNOMED
    56019007
    any prior exposure to agents which inhibit akt as the primary pharmacological activity.
    Description

    inhibit akt

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0812228 (AKT1 gene)
    LOINC
    LP36214-2
    part a: more than two prior courses of chemotherapy (including taxanes) for advanced or metastatic breast cancer.
    Description

    chemotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    part b: any prior chemotherapy for advanced or metastatic breast cancer.
    Description

    chemotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [1,2]
    C0278488 (Carcinoma breast stage IV)

    Similar models

    Eligibility Advanced or Metastatic Breast Cancer, NCT01625286

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    informed consent
    Item
    provision of informed consent
    boolean
    C0021430 (UMLS CUI [1])
    female patient
    Item
    female patient
    boolean
    C0150905 (UMLS CUI [1])
    age
    Item
    aged at least 18 years
    boolean
    C0001779 (UMLS CUI [1])
    breast cancer
    Item
    histological or cytological confirmation of breast cancer with evidence of advanced or metastatic disease (must be er+ve, her2-ve, in part b).
    boolean
    C0678222 (UMLS CUI [1])
    who performance status
    Item
    world health organisation (who) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
    boolean
    C1298650 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    clinically significant abnormalities of glucose metabolism
    Item
    clinically significant abnormalities of glucose metabolism
    boolean
    C0744434 (UMLS CUI [1])
    spinal cord compression
    Item
    spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
    boolean
    C0037926 (UMLS CUI [1])
    C0220650 (UMLS CUI [2])
    systemic diseases, bleeding diatheses
    Item
    evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis b, c and hiv.
    boolean
    C1536063 (UMLS CUI [1])
    C0442893 (UMLS CUI [2])
    inhibit akt
    Item
    any prior exposure to agents which inhibit akt as the primary pharmacological activity.
    boolean
    C0812228 (UMLS CUI [1])
    chemotherapy
    Item
    part a: more than two prior courses of chemotherapy (including taxanes) for advanced or metastatic breast cancer.
    boolean
    C0392920 (UMLS CUI [1])
    chemotherapy
    Item
    part b: any prior chemotherapy for advanced or metastatic breast cancer.
    boolean
    C0392920 (UMLS CUI [1,1])
    C0278488 (UMLS CUI [1,2])

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