ID

36431

Beschreibung

Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT01392131 Brief Summary: Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma Detailed Description: To assess therapeutic efficacy and safety of Oncoxin in hepatocellular carcinoma. To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin. To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin. To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin. To see if there is improved survival in hepatocellular carcinoma patients after administration of oncoxin.

Link

https://clinicaltrials.gov/show/NCT01392131

Stichworte

Versionen (2)
  1. 16/1/19 16/1/19 -
  2. 14/5/19 14/5/19 -
Rechteinhaber

Clinical Research Organization, Dhaka, Bangladesh

Hochgeladen am

14 de mayo de 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    Oncoxin in Hepatocellular Carcinoma NCT01392131

    Englisch

    Eligibility Criteria

    1 Formulare  
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Does the participant have HCC (irrespective of etiology, age, gender and status of underlying liver disease)?
    Beschreibung

    The participant should have HCC (irrespective of etiology, age, gender and status of underlying liver disease)

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2239176
    UMLS CUI [1,2]
    C3641650
    UMLS CUI [1,3]
    C1314792
    UMLS CUI [1,4]
    C0001779
    UMLS CUI [1,5]
    C0079399
    UMLS CUI [1,6]
    C0699749
    Is the participant not a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy?
    Beschreibung

    The participant (with HCC) shoud not be a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0443211
    UMLS CUI [1,3]
    C1548788
    UMLS CUI [2]
    C0543467
    UMLS CUI [3]
    C3665472
    Does the participant have HCC with evidence of tumor metastasis?
    Beschreibung

    The participant should have patients HCC with evidence of tumor metastasis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332120
    UMLS CUI [1,2]
    C0027627
    UMLS CUI [1,3]
    C2239176
    Is the participant voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy?
    Beschreibung

    The participant should be voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0443211
    UMLS CUI [1,3]
    C0558080
    UMLS CUI [2]
    C0543467
    UMLS CUI [3]
    C3665472
    Does the participant have exhausted all treatment options?
    Beschreibung

    Participants should have exhausted all treatment options

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0679646
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0683525
    UMLS CUI [1,4]
    C0231175
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    Is the participant a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy?
    Beschreibung

    The participant should not be a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0443211
    UMLS CUI [1,3]
    C3900053
    UMLS CUI [2]
    C0543467
    UMLS CUI [3]
    C3665472
    Does the participant have no evidence of tumor metastasis?
    Beschreibung

    The patient should not be metastasis free

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C1298908
    Is the participant willing to take established modalities of treatment i.e. surgery and/or chemotherapy?
    Beschreibung

    Willingness for Standard Treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0600109
    UMLS CUI [1,2]
    C0443211
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [2]
    C0543467
    UMLS CUI [3]
    C3665472
    Is the participant voluntarily unwilling to be included in the trial?
    Beschreibung

    Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0558080
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Criteria

    1 Formulare
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Hepatocellular Carcinoma
    Item
    Does the participant have HCC (irrespective of etiology, age, gender and status of underlying liver disease)?
    boolean
    C2239176 (UMLS CUI [1,1])
    C3641650 (UMLS CUI [1,2])
    C1314792 (UMLS CUI [1,3])
    C0001779 (UMLS CUI [1,4])
    C0079399 (UMLS CUI [1,5])
    C0699749 (UMLS CUI [1,6])
    No Treatment Options
    Item
    Is the participant not a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy?
    boolean
    C0087111 (UMLS CUI [1,1])
    C0443211 (UMLS CUI [1,2])
    C1548788 (UMLS CUI [1,3])
    C0543467 (UMLS CUI [2])
    C3665472 (UMLS CUI [3])
    Metastasis
    Item
    Does the participant have HCC with evidence of tumor metastasis?
    boolean
    C0332120 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    C2239176 (UMLS CUI [1,3])
    Refusal of Standard Treatment
    Item
    Is the participant voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy?
    boolean
    C0087111 (UMLS CUI [1,1])
    C0443211 (UMLS CUI [1,2])
    C0558080 (UMLS CUI [1,3])
    C0543467 (UMLS CUI [2])
    C3665472 (UMLS CUI [3])
    Treatment exhausted
    Item
    Does the participant have exhausted all treatment options?
    boolean
    C0679646 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0683525 (UMLS CUI [1,3])
    C0231175 (UMLS CUI [1,4])
    Item Group
    C0680251 (UMLS CUI)
    Therapy options available
    Item
    Is the participant a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy?
    boolean
    C0087111 (UMLS CUI [1,1])
    C0443211 (UMLS CUI [1,2])
    C3900053 (UMLS CUI [1,3])
    C0543467 (UMLS CUI [2])
    C3665472 (UMLS CUI [3])
    No Metastasis
    Item
    Does the participant have no evidence of tumor metastasis?
    boolean
    C0027627 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    Willingness for Standard Treatment
    Item
    Is the participant willing to take established modalities of treatment i.e. surgery and/or chemotherapy?
    boolean
    C0600109 (UMLS CUI [1,1])
    C0443211 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C0543467 (UMLS CUI [2])
    C3665472 (UMLS CUI [3])
    Consent
    Item
    Is the participant voluntarily unwilling to be included in the trial?
    boolean
    C2348568 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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