{
    "info": {
        "nct_id": "NCT01126476",
        "official_title": "Retreatment of Recurrent Tumors Using Proton Therapy",
        "inclusion_criteria": "* Patients with histologically confirmed, non-CNS solid malignancies who have been previously radiated and have a tumor recurrence in or near prior radiation fields. Re-biopsy of the recurrence is not required and left to the discretion of the treating physician, although every effort should be made to confirm recurrence.\n* Patients must have a Karnofsky Performance Status of 60. Life expectancy of 3 months .\n* Age greater or equal to 18.\n* Patients must be able to provide informed consent.\n* Women of child bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods, etc.)\n* Hysterectomy or menopause must be clinically documented.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume.\n* Pregnant women, women planning to become pregnant and women that are nursing.\n* Actively being treated on any research study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with histologically confirmed, non-CNS solid malignancies who have been previously radiated and have a tumor recurrence in or near prior radiation fields. Re-biopsy of the recurrence is not required and left to the discretion of the treating physician, although every effort should be made to confirm recurrence.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed, non-CNS solid malignancies",
                    "criterion": "non-CNS solid malignancies",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "previously radiated",
                    "criterion": "prior radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor recurrence in or near prior radiation fields",
                    "criterion": "tumor recurrence location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "in or near prior radiation fields"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have a Karnofsky Performance Status of 60. Life expectancy of 3 months .",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Status of 60",
                    "criterion": "Karnofsky Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy of 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age greater or equal to 18.",
            "criterions": [
                {
                    "exact_snippets": "Age greater or equal to 18.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to provide informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of child bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods, etc.)",
            "criterions": [
                {
                    "exact_snippets": "Women of child bearing potential",
                    "criterion": "child bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use a recognized method of birth control",
                    "criterion": "use of birth control",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hysterectomy or menopause must be clinically documented.",
            "criterions": [
                {
                    "exact_snippets": "Hysterectomy ... must be clinically documented.",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "menopause must be clinically documented.",
                    "criterion": "menopause",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume.",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation treatment less than 3 months from planned start of re-irradiation",
                    "criterion": "prior radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women, women planning to become pregnant and women that are nursing.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "women planning to become pregnant",
                    "criterion": "pregnancy intention",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "planning to become pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "women that are nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "nursing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Actively being treated on any research study.",
            "criterions": [
                {
                    "exact_snippets": "Actively being treated on any research study.",
                    "criterion": "treatment on research study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}