{
    "info": {
        "nct_id": "NCT00794131",
        "official_title": "Phase I Study of the Safety, Tolerability,and Tumor-Specific Replication of the Intravenous Administration of Green Fluorescent Protein Encoded Genetically Engineered Attenuated Vaccinia Virus, GL-ONC1, in Patients With Advanced Solid Organ Cancers.",
        "inclusion_criteria": "* Diagnosis of histologically or cytologically documented, advanced stage, primary or metastatic solid tumors refractory to standard therapy or for which no curative standard therapy exists.\n* Evidence of measurable or evaluable disease.\n* Age must be ≥ 18 years.\n* All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade ≤ 1. Surgery must have occurred at least 28 days prior to study enrolment.\n* Chemotherapy or radiotherapy (other than small-field palliative radiotherapy), immunotherapy and/or hormonal therapy must have been received > 28 days prior to receiving study drug. Subjects may continue to receive LHRH analogue therapy for prostate cancer in face of rising PSA. Bisphosphonates and anticoagulants are permitted.\n* ECOG Performance Score ≤ 1.\n* Life expectancy of at least 3 months.\n* Required baseline laboratory data include:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 [SI units 10^9/L]\n  * Platelets ≥ 100 x 10^9 [SI units 10^9/L]\n  * Haemoglobin ≥ 9.0 g/dL [SI units gm/L]\n  * Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n  * Bilirubin ≤ 1.5 x ULN\n  * AST/ALT ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver metastases\n* Ejection fraction of ≥50% by MUGA or ECHO.\n* Signed informed consent indicating that the subject is aware of the neoplastic nature of his or her disease and has been informed of the procedures to be followed, the experimental nature of the therapy, the alternatives and the potential benefits, side effects, risks, and discomforts.\n* Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.\n* Female patients must have a negative pregnancy test within five days prior to treatment.\n* Female patients of childbearing potential who are not surgically sterile or postmenopausal and male patients who are not surgically sterile must agree to use highly effective contraception. Barrier methods for contraception must be applied during the treatment period and up to day 60 after the last virus application. The patient must agree to sign his or her consent on this particular inclusion criterion.\n\nAdditional Inclusion Criteria Relevant for Cohort 8 and the Phase IB Expansion Cohort:\n\n1. Diagnosis of histologically or cytologically documented, advanced stage solid tumor (e.g., primary or metastatic breast, prostate or colorectal cancer) refractory to standard therapy or for which no curative standard therapy exists.\n2. Evidence of measurable or evaluable disease.\n3. Disease that can be safely serially biopsied.\n4. Circulating tumor cell count > 10 for analyses of tumor cell viral delivery.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior therapy with a cytolytic virus of any type.\n* Concurrent therapy with any other investigational anticancer agent.\n* Concurrent vaccines or immunotherapy during, and for 30 days before or after, study therapy.\n* Concurrent antiviral agent active against vaccinia virus (e.g. cidofovir, vaccinia immunoglobulin, imatinib, ST-246) during course of study.\n* Patients vaccinated with vaccinia virus within the past 10 years.\n* Patients with known brain metastases: due to poor prognosis and risk of developing progressive neurological dysfunction that would confound the evaluation of neurological or other adverse events.\n* Patients with known allergy to ovalbumin or other egg products.\n* Patients with immune system disorders or who are receiving immunosuppressive therapy or any steroids.\n* Patients with clinically significant dermatological disorders, e.g. eczema or psoriasis, or any unhealed skin wounds or ulcers, as assessed by the principal investigator during the screening and during the study.\n* Patients with fevers, or any systemic infections, including known HIV infection, hepatitis B or C.\n* Prior splenectomy.\n* Previous organ transplant.\n* Pregnant or breast-feeding women.\n* Clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris or myocardial infarction within one year prior to study entry, or grade 2 or higher compromised left ventricular ejection fraction (as determined by MUGA).\n* Dementia or altered mental status that would prohibit informed consent.\n* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the principal investigator, would make the subject inappropriate for this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Diagnosis of histologically or cytologically documented, advanced stage, primary or metastatic solid tumors refractory to standard therapy or for which no curative standard therapy exists.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of histologically or cytologically documented",
                    "criterion": "tumor documentation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced stage",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary or metastatic solid tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "primary",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to standard therapy",
                    "criterion": "treatment response",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no curative standard therapy exists",
                    "criterion": "availability of curative therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of measurable or evaluable disease.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of measurable or evaluable disease.",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age must be ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age must be ≥ 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade ≤ 1. Surgery must have occurred at least 28 days prior to study enrolment.",
            "criterions": [
                {
                    "exact_snippets": "All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade ≤ 1.",
                    "criterion": "acute toxic effects",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Surgery must have occurred at least 28 days prior to study enrolment.",
                    "criterion": "surgery timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy or radiotherapy (other than small-field palliative radiotherapy), immunotherapy and/or hormonal therapy must have been received > 28 days prior to receiving study drug. Subjects may continue to receive LHRH analogue therapy for prostate cancer in face of rising PSA. Bisphosphonates and anticoagulants are permitted.",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy ... must have been received > 28 days prior to receiving study drug.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy (other than small-field palliative radiotherapy) ... must have been received > 28 days prior to receiving study drug.",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "immunotherapy ... must have been received > 28 days prior to receiving study drug.",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hormonal therapy must have been received > 28 days prior to receiving study drug.",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects may continue to receive LHRH analogue therapy for prostate cancer in face of rising PSA.",
                    "criterion": "LHRH analogue therapy",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Bisphosphonates ... are permitted.",
                    "criterion": "bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anticoagulants are permitted.",
                    "criterion": "anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Score ≤ 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Score ≤ 1",
                    "criterion": "ECOG Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Required baseline laboratory data include:",
            "criterions": [
                {
                    "exact_snippets": "Required baseline laboratory data",
                    "criterion": "baseline laboratory data",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 [SI units 10^9/L]",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 10^9",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100 x 10^9 [SI units 10^9/L]",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100 x 10^9 [SI units 10^9/L]",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Haemoglobin ≥ 9.0 g/dL [SI units gm/L]",
            "criterions": [
                {
                    "exact_snippets": "Haemoglobin ≥ 9.0 g/dL",
                    "criterion": "haemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 x upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 x upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤ 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 1.5 x ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST/ALT ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver metastases",
            "criterions": [
                {
                    "exact_snippets": "AST/ALT ≤ 2.5 x ULN",
                    "criterion": "AST/ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST/ALT ... ≤ 5 x ULN in the presence of liver metastases",
                    "criterion": "AST/ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "presence of liver metastases"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ejection fraction of ≥50% by MUGA or ECHO.",
            "criterions": [
                {
                    "exact_snippets": "Ejection fraction of ≥50%",
                    "criterion": "ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent indicating that the subject is aware of the neoplastic nature of his or her disease and has been informed of the procedures to be followed, the experimental nature of the therapy, the alternatives and the potential benefits, side effects, risks, and discomforts.",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subject is aware of the neoplastic nature of his or her disease",
                    "criterion": "awareness of disease nature",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "informed of the procedures to be followed",
                    "criterion": "awareness of procedures",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "informed of ... the experimental nature of the therapy",
                    "criterion": "awareness of therapy nature",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "informed of ... the alternatives",
                    "criterion": "awareness of alternatives",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "informed of ... the potential benefits",
                    "criterion": "awareness of potential benefits",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "informed of ... side effects",
                    "criterion": "awareness of side effects",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "informed of ... risks",
                    "criterion": "awareness of risks",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "informed of ... discomforts",
                    "criterion": "awareness of discomforts",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to comply with scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to comply with ... treatment plan",
                    "criterion": "compliance with treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients must have a negative pregnancy test within five days prior to treatment.",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within five days prior to treatment",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within five days prior to treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients of childbearing potential who are not surgically sterile or postmenopausal and male patients who are not surgically sterile must agree to use highly effective contraception. Barrier methods for contraception must be applied during the treatment period and up to day 60 after the last virus application. The patient must agree to sign his or her consent on this particular inclusion criterion.",
            "criterions": [
                {
                    "exact_snippets": "Female patients of childbearing potential",
                    "criterion": "female patients of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not surgically sterile",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "male patients who are not surgically sterile",
                    "criterion": "male surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use highly effective contraception",
                    "criterion": "use of highly effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Barrier methods for contraception must be applied during the treatment period and up to day 60 after the last virus application",
                    "criterion": "use of barrier methods for contraception",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the treatment period and up to day 60 after the last virus application"
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient must agree to sign his or her consent on this particular inclusion criterion",
                    "criterion": "consent to inclusion criterion",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Additional Inclusion Criteria Relevant for Cohort 8 and the Phase IB Expansion Cohort:",
            "criterions": [
                {
                    "exact_snippets": "Cohort 8",
                    "criterion": "cohort",
                    "requirements": [
                        {
                            "requirement_type": "relevance",
                            "expected_value": "Cohort 8"
                        }
                    ]
                },
                {
                    "exact_snippets": "Phase IB Expansion Cohort",
                    "criterion": "cohort",
                    "requirements": [
                        {
                            "requirement_type": "relevance",
                            "expected_value": "Phase IB Expansion Cohort"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Diagnosis of histologically or cytologically documented, advanced stage solid tumor (e.g., primary or metastatic breast, prostate or colorectal cancer) refractory to standard therapy or for which no curative standard therapy exists.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of histologically or cytologically documented, advanced stage solid tumor",
                    "criterion": "advanced stage solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to standard therapy",
                    "criterion": "refractory to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no curative standard therapy exists",
                    "criterion": "curative standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Evidence of measurable or evaluable disease.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of measurable or evaluable disease.",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "evaluability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Disease that can be safely serially biopsied.",
            "criterions": [
                {
                    "exact_snippets": "Disease that can be safely serially biopsied",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "biopsy safety",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "serial biopsy capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Circulating tumor cell count > 10 for analyses of tumor cell viral delivery.",
            "criterions": [
                {
                    "exact_snippets": "Circulating tumor cell count > 10",
                    "criterion": "circulating tumor cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior therapy with a cytolytic virus of any type.",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with a cytolytic virus",
                    "criterion": "prior therapy with a cytolytic virus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent therapy with any other investigational anticancer agent.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent therapy with any other investigational anticancer agent.",
                    "criterion": "concurrent therapy with investigational anticancer agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent vaccines or immunotherapy during, and for 30 days before or after, study therapy.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent vaccines or immunotherapy during, and for 30 days before or after, study therapy.",
                    "criterion": "concurrent vaccines or immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "not allowed during, and for 30 days before or after, study therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent antiviral agent active against vaccinia virus (e.g. cidofovir, vaccinia immunoglobulin, imatinib, ST-246) during course of study.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent antiviral agent active against vaccinia virus (e.g. cidofovir, vaccinia immunoglobulin, imatinib, ST-246)",
                    "criterion": "antiviral agent",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active against vaccinia virus"
                        },
                        {
                            "requirement_type": "concurrency",
                            "expected_value": "during course of study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients vaccinated with vaccinia virus within the past 10 years.",
            "criterions": [
                {
                    "exact_snippets": "Patients vaccinated with vaccinia virus within the past 10 years.",
                    "criterion": "vaccinia virus vaccination",
                    "requirements": [
                        {
                            "requirement_type": "time since vaccination",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known brain metastases: due to poor prognosis and risk of developing progressive neurological dysfunction that would confound the evaluation of neurological or other adverse events.",
            "criterions": [
                {
                    "exact_snippets": "Patients with known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known allergy to ovalbumin or other egg products.",
            "criterions": [
                {
                    "exact_snippets": "known allergy to ovalbumin",
                    "criterion": "allergy to ovalbumin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergy to ... other egg products",
                    "criterion": "allergy to egg products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with immune system disorders or who are receiving immunosuppressive therapy or any steroids.",
            "criterions": [
                {
                    "exact_snippets": "Patients with immune system disorders",
                    "criterion": "immune system disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving ... any steroids",
                    "criterion": "steroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with clinically significant dermatological disorders, e.g. eczema or psoriasis, or any unhealed skin wounds or ulcers, as assessed by the principal investigator during the screening and during the study.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant dermatological disorders, e.g. eczema or psoriasis",
                    "criterion": "dermatological disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "unhealed skin wounds or ulcers",
                    "criterion": "skin wounds or ulcers",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior splenectomy.",
            "criterions": [
                {
                    "exact_snippets": "Prior splenectomy.",
                    "criterion": "splenectomy",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous organ transplant.",
            "criterions": [
                {
                    "exact_snippets": "Previous organ transplant.",
                    "criterion": "organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris or myocardial infarction within one year prior to study entry, or grade 2 or higher compromised left ventricular ejection fraction (as determined by MUGA).",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiac disease (New York Heart Association, Class III or IV)",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "New York Heart Association, Class III",
                                "New York Heart Association, Class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-existing arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within one year prior to study entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 2 or higher compromised left ventricular ejection fraction (as determined by MUGA)",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Dementia or altered mental status that would prohibit informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "altered mental status",
                    "criterion": "altered mental status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the principal investigator, would make the subject inappropriate for this study.",
            "criterions": [
                {
                    "exact_snippets": "Other severe, acute, or chronic medical or psychiatric condition",
                    "criterion": "medical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "severe",
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients with fevers, or any systemic infections, including known HIV infection, hepatitis B or C.",
            "criterions": [
                {
                    "exact_snippets": "fevers",
                    "criterion": "fever",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic infections",
                    "criterion": "systemic infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}