WebService-ClinicalTrialsdotGov

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      with stage IV breast cancer.
    '
                           },
          'location_countries' => {
                                  'country' => 'United States'
                                },
          'is_section_801' => 'Yes',
          'secondary_outcome' => [
                                 {
                                   'time_frame' => '3 years',
                                   'measure' => 'To determine if cellular and humoral immunity is induced by serial vaccination with DC/tumor fusion cells and rhIL-12.',
                                   'safety_issue' => 'No'
                                 },
                                 {
                                   'time_frame' => '3 years',
                                   'measure' => 'To determine if vaccination with DC/tumor fusions and rhIL-12 results in clinically measurable disease responses.',
                                   'safety_issue' => 'No'
                                 }
                               ],
          'responsible_party' => {
                                 'name_title' => 'David Avigan, MD',
                                 'organization' => 'Beth Israel Deaconess Medical Center'
                               },
          'eligibility' => {
                           'healthy_volunteers' => 'No',
                           'minimum_age' => '18 Years',
                           'criteria' => {
                                         'textblock' => '
        Inclusion Criteria:

          -  Stage IV breast cancer with measurable disease and accessible tumor

          -  ECOG Performance Status 0-2 with greater than six week life expectancy

          -  18 years of age or older

          -  Laboratory values as outlined in the protocol

          -  Received a maximum of 2 prior chemotherapy regimens for metastatic disease and may
             have had any number or prior hormonal treatments

        Exclusion Criteria:

          -  Patients must not have received other immunotherapy treatment in the three months
             prior to the initial vaccination

          -  Patients may not be on herceptin therapy during this protocol and may not have
             received it for four weeks prior to initial vaccination

          -  Patients must not have received chemotherapy or hormonal treatment for four weeks
             prior to the initial vaccination

          -  Clinical evidence of CNS disease

          -  Clinically significant autoimmune disease

          -  Patients who are HIV+

          -  Serious intercurrent illness such as infection requiring IV antibiotics, or
             significant cardiac disease characterized by significant arrhythmia, ischemic
             coronary disease or congestive heart failure

          -  Pregnant of lactating women will be excluded, all premenopausal women must undergo
             pregnancy testing'
                                       },
                           'maximum_age' => 'N/A',
                           'gender' => 'Female'
                         },
          'phase' => 'Phase 1/Phase 2',
          'lastchanged_date' => 'April 7, 2010',
          'start_date' => 'December 2009',
          'is_fda_regulated' => 'Yes',
          'required_header' => {
                               'download_date' => 'Information obtained from ClinicalTrials.gov on November 04, 2010',
                               'url' => 'http://clinicaltrials.gov/show/NCT00622401',
                               'link_text' => 'Link to the current ClinicalTrials.gov record.'
                             },
          'overall_contact_backup' => {
                                      'email' => 'yyuan1@bidmc.harvard.edu',
                                      'phone' => '617-667-1998',
                                      'last_name' => 'Emily Yuan'
                                    },
          'condition' => 'Breast Cancer'
        };

my $Study =
  WebService::ClinicalTrialsdotGov::Study->new( $rh_study );

isa_ok( $Study, 'WebService::ClinicalTrialsdotGov::Study' );



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