{
    "info": {
        "nct_id": "NCT01717391",
        "official_title": "Improving Pelvic Cancer Patient Chemoradiotherapy Outcomes With FLT PET Imaging",
        "inclusion_criteria": "* Ability to understand and willingness to sign a written informed consent document.\n* Recommended to undergo pelvic irradiation with concurrent chemotherapy.\n* At least 18 years of age. Pediatrics would be best served by a protocol designed for their specific needs.\n* Karnofsky Performance Status of at least 60% at time of screening.\n* Life expectancy of greater than 6 months.\n* Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:\n\n  * leukocytes at least 3,000 / µL\n  * absolute neutrophil count of at least 1500 / µL\n  * platelets of at least 100,000 / µL\n  * creatinine equal to or less than the upper limit of normal\n* not pregnant (as applicable)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* history of allergic reactions attributed to compounds of similar chemical or biologic composition to FLT\n* an oncology research protocol requiring full pelvic radiation (i.e., 4 field box technique)\n* uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* subjects taking nucleoside analog medications such as those used as antiretroviral agents.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Ability to understand and willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recommended to undergo pelvic irradiation with concurrent chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Recommended to undergo pelvic irradiation",
                    "criterion": "pelvic irradiation",
                    "requirements": [
                        {
                            "requirement_type": "recommendation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recommendation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 18 years of age. Pediatrics would be best served by a protocol designed for their specific needs.",
            "criterions": [
                {
                    "exact_snippets": "At least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky Performance Status of at least 60% at time of screening.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Status of at least 60%",
                    "criterion": "Karnofsky Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of greater than 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of greater than 6 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:",
            "criterions": [
                {
                    "exact_snippets": "normal organ and marrow function",
                    "criterion": "organ and marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* leukocytes at least 3,000 / µL",
            "criterions": [
                {
                    "exact_snippets": "leukocytes at least 3,000 / µL",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "/ µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* absolute neutrophil count of at least 1500 / µL",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count of at least 1500 / µL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* platelets of at least 100,000 / µL",
            "criterions": [
                {
                    "exact_snippets": "platelets of at least 100,000 / µL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/ µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* creatinine equal to or less than the upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "creatinine equal to or less than the upper limit of normal",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* not pregnant (as applicable)",
            "criterions": [
                {
                    "exact_snippets": "not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* history of allergic reactions attributed to compounds of similar chemical or biologic composition to FLT",
            "criterions": [
                {
                    "exact_snippets": "history of allergic reactions attributed to compounds of similar chemical or biologic composition to FLT",
                    "criterion": "allergic reactions to compounds similar to FLT",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* an oncology research protocol requiring full pelvic radiation (i.e., 4 field box technique)",
            "criterions": [
                {
                    "exact_snippets": "full pelvic radiation",
                    "criterion": "pelvic radiation",
                    "requirements": [
                        {
                            "requirement_type": "technique",
                            "expected_value": "full"
                        }
                    ]
                },
                {
                    "exact_snippets": "4 field box technique",
                    "criterion": "radiation technique",
                    "requirements": [
                        {
                            "requirement_type": "specific technique",
                            "expected_value": "4 field box"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ongoing or active infection",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing or active"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit compliance with study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* subjects taking nucleoside analog medications such as those used as antiretroviral agents.",
            "criterions": [
                {
                    "exact_snippets": "subjects taking nucleoside analog medications",
                    "criterion": "nucleoside analog medication usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "such as those used as antiretroviral agents",
                    "criterion": "antiretroviral agent usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}