{
    "info": {
        "nct_id": "NCT01240720",
        "official_title": "A Phase I/II Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer",
        "inclusion_criteria": "1. Phase I:\n\n   Patients with cancer, with progressive disease in pre-study period, refractory to conventional standard treatments.\n\n   Solid Tumor: Histologically/cytologically confirmed diagnosis of cancer, preferably lung cancer, prostate cancer or colorectal cancer (CRC). At least one measurable (minimum 2.0 cm), non irradiated lesion defined according to modified RECIST criteria i.e. whenever the measurable disease is restricted to a solitary lesion, its neoplastic nature need not be confirmed by cytology/histology.\n\n   Lymphoproliferative Diseases: Histologically/cytologically confirmed diagnosis of lymphoproliferative disease. At least one measurable (minimum 2.0 cm) non irradiated lesion defined according to modified RECIST criteria, i.e. whenever the measurable disease is restricted to a solitary lesion; its neoplastic nature needs to be confirmed by cytology/histology.\n\n   Phase II:\n\n   Patients with lymphoma, breast cancer or lung cancer with progressive disease in pre-study period, refractory to conventional standard treatments, will be enrolled in the study. Presence of brain metastases at time of screening does not represent an exclusion criterion. Lesions will be evaluated according to RECIST for solid tumors or to the Revised response criteria for malignant lymphoma (Cheson BD, JCO 2007, 25, 579-58) for lymphomas.\n2. ECOG performance status grade 0 or 1.\n3. Age ≥18.\n4. Adequate haematological, liver and renal function (haemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1.50 x 109/L; platelets ≥ 100 x 109/L, bilirubin within UNL; alkaline phosphatase≤ 2.5 x UNL; ALT, AST ≤ UNL or ≤ 2.5 x UNL in case of liver metastases; albumin ≥ 2.5 g/dL; creatinine ≤ UNL.\n5. All acute toxic effects (excluding alopecia) of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.3.0) Grade ≤ 1.\n6. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.\n7. If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.\n8. Evidence of a personally signed and dated IEC-approved Informed Consent indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study.\n9. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n10. Life expectancy of at least 3 months.\n11. Signed and dated informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Chemotherapy, radiation, hormonotherapy or immunotherapy or participation in any investigational drug study within 4 weeks of RIT treatment at the RD (6 weeks in case of prior nitroureas chemotherapy).\n2. Prior radiation dose > 30% of bone marrow volume.\n3. Presence of cirrhosis or active hepatitis.\n4. Presence of serious cardiac (congestive heart failure, heart insufficiency > grade II NYHA, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorders.\n5. Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.\n6. Recovery from major trauma including surgery within 4 weeks of administration of study treatment.\n7. Pregnancy or lactation or unwillingness to use adequate method of birth control.\n8. Active infection or incomplete wound healing.\n9. Known history of allergy to intravenously administered proteins / peptides / antibodies.\n10. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Phase I:",
                "criterions": [
                    {
                        "exact_snippets": "Phase I",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "I"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Phase I",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "I"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Patients with cancer, with progressive disease in pre-study period, refractory to conventional standard treatments.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with cancer",
                        "criterion": "cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "progressive disease in pre-study period",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "progressive"
                        }
                    },
                    {
                        "exact_snippets": "refractory to conventional standard treatments",
                        "criterion": "refractory to conventional standard treatments",
                        "requirement": {
                            "requirement_type": "treatment response",
                            "expected_value": "refractory"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with cancer",
                        "criterion": "cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "progressive disease in pre-study period",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "progressive"
                        }
                    },
                    {
                        "exact_snippets": "refractory to conventional standard treatments",
                        "criterion": "refractory to conventional standard treatments",
                        "requirement": {
                            "requirement_type": "treatment response",
                            "expected_value": "refractory"
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "Solid Tumor: Histologically/cytologically confirmed diagnosis of cancer, preferably lung cancer, prostate cancer or colorectal cancer (CRC). At least one measurable (minimum 2.0 cm), non irradiated lesion defined according to modified RECIST criteria i.e. whenever the measurable disease is restricted to a solitary lesion, its neoplastic nature need not be confirmed by cytology/histology.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically/cytologically confirmed diagnosis of cancer",
                        "criterion": "cancer diagnosis",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "preferably lung cancer, prostate cancer or colorectal cancer (CRC)",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "preference",
                            "expected_value": [
                                "lung cancer",
                                "prostate cancer",
                                "colorectal cancer"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable (minimum 2.0 cm), non irradiated lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable (minimum 2.0 cm), non irradiated lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.0,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable (minimum 2.0 cm), non irradiated lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "irradiation status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "defined according to modified RECIST criteria",
                        "criterion": "lesion definition criteria",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "modified RECIST"
                        }
                    },
                    {
                        "exact_snippets": "whenever the measurable disease is restricted to a solitary lesion, its neoplastic nature need not be confirmed by cytology/histology",
                        "criterion": "solitary lesion confirmation",
                        "requirement": {
                            "requirement_type": "confirmation requirement",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Lymphoproliferative Diseases: Histologically/cytologically confirmed diagnosis of lymphoproliferative disease. At least one measurable (minimum 2.0 cm) non irradiated lesion defined according to modified RECIST criteria, i.e. whenever the measurable disease is restricted to a solitary lesion; its neoplastic nature needs to be confirmed by cytology/histology.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically/cytologically confirmed diagnosis of lymphoproliferative disease",
                        "criterion": "lymphoproliferative disease",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically/cytologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable (minimum 2.0 cm) non irradiated lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable (minimum 2.0 cm) non irradiated lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.0,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable (minimum 2.0 cm) non irradiated lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "irradiation status",
                            "expected_value": "non irradiated"
                        }
                    },
                    {
                        "exact_snippets": "measurable disease is restricted to a solitary lesion; its neoplastic nature needs to be confirmed by cytology/histology",
                        "criterion": "solitary lesion",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "neoplastic nature confirmed by cytology/histology"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Patients with lymphoma, breast cancer or lung cancer with progressive disease in pre-study period, refractory to conventional standard treatments, will be enrolled in the study. Presence of brain metastases at time of screening does not represent an exclusion criterion. Lesions will be evaluated according to RECIST for solid tumors or to the Revised response criteria for malignant lymphoma (Cheson BD, JCO 2007, 25, 579-58) for lymphomas.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with lymphoma, breast cancer or lung cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "lymphoma",
                                "breast cancer",
                                "lung cancer"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "progressive disease in pre-study period",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "progressive"
                        }
                    },
                    {
                        "exact_snippets": "refractory to conventional standard treatments",
                        "criterion": "treatment response",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": "refractory"
                        }
                    },
                    {
                        "exact_snippets": "Presence of brain metastases at time of screening does not represent an exclusion criterion",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Lesions will be evaluated according to RECIST for solid tumors",
                        "criterion": "lesion evaluation for solid tumors",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "RECIST"
                        }
                    },
                    {
                        "exact_snippets": "Lesions will be evaluated ... to the Revised response criteria for malignant lymphoma",
                        "criterion": "lesion evaluation for lymphomas",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "Revised response criteria for malignant lymphoma"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. ECOG performance status grade 0 or 1.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status grade 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Age ≥18.",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Adequate haematological, liver and renal function (haemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1.50 x 109/L; platelets ≥ 100 x 109/L, bilirubin within UNL; alkaline phosphatase≤ 2.5 x UNL; ALT, AST ≤ UNL or ≤ 2.5 x UNL in case of liver metastases; albumin ≥ 2.5 g/dL; creatinine ≤ UNL.",
                "criterions": [
                    {
                        "exact_snippets": "haemoglobin ≥ 9 g/dL",
                        "criterion": "haemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "absolute neutrophil count (ANC) ≥ 1.50 x 109/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 109/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets ≥ 100 x 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "bilirubin within UNL",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "within UNL"
                        }
                    },
                    {
                        "exact_snippets": "alkaline phosphatase≤ 2.5 x UNL",
                        "criterion": "alkaline phosphatase level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x UNL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT, AST ≤ UNL or ≤ 2.5 x UNL in case of liver metastases",
                        "criterion": "ALT, AST levels",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": [
                                "≤ UNL",
                                "≤ 2.5 x UNL in case of liver metastases"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "albumin ≥ 2.5 g/dL",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine ≤ UNL",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "≤ UNL"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. All acute toxic effects (excluding alopecia) of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.3.0) Grade ≤ 1.",
                "criterions": [
                    {
                        "exact_snippets": "All acute toxic effects (excluding alopecia) of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.3.0) Grade ≤ 1.",
                        "criterion": "acute toxic effects of prior therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "NCI CTCAE v.3.0 Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Negative serum pregnancy test for females of childbearing potential",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "females of childbearing potential",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "within 14 days of starting treatment",
                        "criterion": "timing of serum pregnancy test",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.",
                "criterions": [
                    {
                        "exact_snippets": "If of childbearing potential",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "agreement to use adequate contraceptive methods",
                        "criterion": "use of contraceptive methods",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "beginning at the screening visit and continuing until 3 months following last treatment with study drug",
                        "criterion": "duration of contraceptive use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "from screening visit until 3 months after last treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Evidence of a personally signed and dated IEC-approved Informed Consent indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study.",
                "criterions": [
                    {
                        "exact_snippets": "personally signed and dated IEC-approved Informed Consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.",
                "criterions": [
                    {
                        "exact_snippets": "Willingness and ability to comply with the scheduled visits",
                        "criterion": "compliance with scheduled visits",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with the scheduled visits",
                        "criterion": "compliance with scheduled visits",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with the ... treatment plan",
                        "criterion": "compliance with treatment plan",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with the ... treatment plan",
                        "criterion": "compliance with treatment plan",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with the ... laboratory tests",
                        "criterion": "compliance with laboratory tests",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with the ... laboratory tests",
                        "criterion": "compliance with laboratory tests",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with the ... other study procedures",
                        "criterion": "compliance with other study procedures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with the ... other study procedures",
                        "criterion": "compliance with other study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Life expectancy of at least 3 months.",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy of at least 3 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Signed and dated informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Signed and dated informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "signed and dated"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
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                "exact_snippets": "failed",
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                    "requirement_type": "failed",
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                }
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
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                }
            }
        },
        {
            "identified_line": {
                "line": "Phase II:",
                "criterions": []
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "1. Chemotherapy, radiation, hormonotherapy or immunotherapy or participation in any investigational drug study within 4 weeks of RIT treatment at the RD (6 weeks in case of prior nitroureas chemotherapy).",
                "criterions": [
                    {
                        "exact_snippets": "Chemotherapy ... within 4 weeks of RIT treatment ... (6 weeks in case of prior nitroureas chemotherapy)",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "radiation ... within 4 weeks of RIT treatment",
                        "criterion": "radiation",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "hormonotherapy ... within 4 weeks of RIT treatment",
                        "criterion": "hormonotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "immunotherapy ... within 4 weeks of RIT treatment",
                        "criterion": "immunotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "participation in any investigational drug study within 4 weeks of RIT treatment",
                        "criterion": "participation in investigational drug study",
                        "requirement": {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Prior radiation dose > 30% of bone marrow volume.",
                "criterions": [
                    {
                        "exact_snippets": "Prior radiation dose > 30% of bone marrow volume.",
                        "criterion": "prior radiation dose",
                        "requirement": {
                            "requirement_type": "percentage of bone marrow volume",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Presence of cirrhosis or active hepatitis.",
                "criterions": [
                    {
                        "exact_snippets": "Presence of cirrhosis",
                        "criterion": "cirrhosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis",
                        "criterion": "hepatitis",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Presence of serious cardiac (congestive heart failure, heart insufficiency > grade II NYHA, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorders.",
                "criterions": [
                    {
                        "exact_snippets": "Presence of serious cardiac (congestive heart failure ...",
                        "criterion": "serious cardiac disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "heart insufficiency > grade II NYHA",
                        "criterion": "heart insufficiency",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade II NYHA"
                            }
                        }
                    },
                    {
                        "exact_snippets": "angina pectoris",
                        "criterion": "angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction within one year prior to study entry",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled ... arrhythmia",
                        "criterion": "uncontrolled arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Presence of ... neurological ... disorders",
                        "criterion": "neurological disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Presence of ... psychiatric disorders",
                        "criterion": "psychiatric disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.",
                "criterions": [
                    {
                        "exact_snippets": "Presence of uncontrolled intercurrent illness",
                        "criterion": "uncontrolled intercurrent illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any condition which in the judgement of the investigator would place the subject at undue risk",
                        "criterion": "condition placing subject at undue risk",
                        "requirement": {
                            "requirement_type": "judgement of the investigator",
                            "expected_value": "undue risk"
                        }
                    },
                    {
                        "exact_snippets": "any condition which in the judgement of the investigator would ... interfere with the results of the study",
                        "criterion": "condition interfering with study results",
                        "requirement": {
                            "requirement_type": "judgement of the investigator",
                            "expected_value": "interference with study results"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Recovery from major trauma including surgery within 4 weeks of administration of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Recovery from major trauma including surgery within 4 weeks of administration of study treatment.",
                        "criterion": "recovery from major trauma including surgery",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Pregnancy or lactation or unwillingness to use adequate method of birth control.",
                "criterions": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactation",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unwillingness to use adequate method of birth control",
                        "criterion": "use of birth control",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Active infection or incomplete wound healing.",
                "criterions": [
                    {
                        "exact_snippets": "Active infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "incomplete wound healing",
                        "criterion": "wound healing",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "incomplete"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Known history of allergy to intravenously administered proteins / peptides / antibodies.",
                "criterions": [
                    {
                        "exact_snippets": "Known history of allergy to intravenously administered proteins",
                        "criterion": "allergy to intravenously administered proteins",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of allergy to ... peptides",
                        "criterion": "allergy to intravenously administered peptides",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of allergy to ... antibodies",
                        "criterion": "allergy to intravenously administered antibodies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.",
                "criterions": [
                    {
                        "exact_snippets": "Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.",
                        "criterion": "conditions affecting compliance",
                        "requirement": {
                            "requirement_type": "opinion of the investigator",
                            "expected_value": "could hamper compliance with the study protocol"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}