0 Bedömningar
ID

14590

Beskrivning

Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT02072486

Länk

https://clinicaltrials.gov/show/NCT02072486

Nyckelord

Versioner (1)
  1. 2016-04-22 2016-04-22 -
Uppladdad den

22 april 2016

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Adult Hepatocellular Carcinoma NCT02072486

    Engelsk

    Eligibility Adult Hepatocellular Carcinoma NCT02072486

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    subject or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
    Beskrivning

    Informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    outpatients with histologically/cytologically documented or radiographically diagnosed unresectable hepatocellular carcinoma (hcc) who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made; radiographic diagnosis needs typical findings of hcc by a radiographic method, i.e. on multi-dimensional dynamic computed tomography (ct), ct hepatic arteriography (ctha)/ct arterial portography (ctap) or magnetic resonance imaging (mri)
    Beskrivning

    hepatocellular carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2239176 (Liver carcinoma)
    SNOMED
    109841003
    patients must have a life expectancy of at least 8 weeks
    Beskrivning

    life expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    patients must not have any evidence of bleeding diathesis or active gastrointestinal bleeding
    Beskrivning

    bleeding diathesis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005779 (Blood Coagulation Disorders)
    SNOMED
    64779008
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    Beskrivning

    intercurrent illness

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3640977 (Significant Intercurrent Illness)
    pregnant or nursing female subjects
    Beskrivning

    pregnant or nursing

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    unwilling or unable to follow protocol requirements
    Beskrivning

    Protocol Compliance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0525058 (Protocol Compliance)
    UMLS CUI [2]
    C0009488 (Comorbidity)
    any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
    Beskrivning

    Study drug

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1709261 (Non-Compliance With Study Drug)
    patients who have had prior anti-angiogenic therapy, including but not limited to sorafenib, brivanib, bevacizumab, or sunitinib; prior treatment with liver directed, ablative or surgical therapies will be permitted as long as there is documented progression justifying the need for starting sorafenib therapy
    Beskrivning

    anti-angiogenic therapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0596087 (Angiogenesis Inhibitors)
    SNOMED
    409408008
    no known contraindications to anti-angiogenics such as severe coronary artery disease, recent myocardial infarction or stroke within 6 months, bleeding peptic ulcer or varices within last 3 months, and any other major illness that may jeopardize study treatment or follow up
    Beskrivning

    severe coronary artery disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0010068 (Coronary heart disease)
    SNOMED
    53741008
    Tillbaka till toppen

    Similar models

    Eligibility Adult Hepatocellular Carcinoma NCT02072486

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed consent
    Item
    subject or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
    boolean
    C0021430 (UMLS CUI [1])
    hepatocellular carcinoma
    Item
    outpatients with histologically/cytologically documented or radiographically diagnosed unresectable hepatocellular carcinoma (hcc) who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made; radiographic diagnosis needs typical findings of hcc by a radiographic method, i.e. on multi-dimensional dynamic computed tomography (ct), ct hepatic arteriography (ctha)/ct arterial portography (ctap) or magnetic resonance imaging (mri)
    boolean
    C2239176 (UMLS CUI [1])
    life expectancy
    Item
    patients must have a life expectancy of at least 8 weeks
    boolean
    C0023671 (UMLS CUI [1])
    bleeding diathesis
    Item
    patients must not have any evidence of bleeding diathesis or active gastrointestinal bleeding
    boolean
    C0005779 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    intercurrent illness
    Item
    uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    boolean
    C3640977 (UMLS CUI [1])
    pregnant or nursing
    Item
    pregnant or nursing female subjects
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    Protocol Compliance
    Item
    unwilling or unable to follow protocol requirements
    boolean
    C0525058 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    Study drug
    Item
    any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
    boolean
    C1709261 (UMLS CUI [1])
    anti-angiogenic therapy
    Item
    patients who have had prior anti-angiogenic therapy, including but not limited to sorafenib, brivanib, bevacizumab, or sunitinib; prior treatment with liver directed, ablative or surgical therapies will be permitted as long as there is documented progression justifying the need for starting sorafenib therapy
    boolean
    C0596087 (UMLS CUI [1])
    severe coronary artery disease
    Item
    no known contraindications to anti-angiogenics such as severe coronary artery disease, recent myocardial infarction or stroke within 6 months, bleeding peptic ulcer or varices within last 3 months, and any other major illness that may jeopardize study treatment or follow up
    boolean
    C0010068 (UMLS CUI [1])
    Tillbaka till toppen 

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