{
    "info": {
        "nct_id": "NCT01774760",
        "official_title": "Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer",
        "inclusion_criteria": "* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better\n* Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck\n* Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm\n* Patients with nodal neck metastases of head and neck cancer are eligible\n* Mental status: Patients must be able to understand the meaning of the study\n* The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff\n* Patient, if female, must not be pregnant or lactating at the time of the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease.\n* Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer.\n* Patient must not have an uncontrolled serious infection\n* Patients with organ metastases in liver, bone, brain or lung.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better",
            "criterions": [
                {
                    "exact_snippets": "Performance status: Karnofsky score 70 or better",
                    "criterion": "Karnofsky score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: ... WHO performance status 2 or better",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck",
            "criterions": [
                {
                    "exact_snippets": "Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck",
                    "criterion": "squamous cell carcinoma of the head and neck",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm",
            "criterions": [
                {
                    "exact_snippets": "Primary tumor diameter ... must be at least 15 mm",
                    "criterion": "primary tumor diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with nodal neck metastases of head and neck cancer are eligible",
            "criterions": [
                {
                    "exact_snippets": "nodal neck metastases of head and neck cancer",
                    "criterion": "nodal neck metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "head and neck cancer",
                    "criterion": "head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mental status: Patients must be able to understand the meaning of the study",
            "criterions": [
                {
                    "exact_snippets": "Mental status: Patients must be able to understand the meaning of the study",
                    "criterion": "mental status",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff",
            "criterions": [
                {
                    "exact_snippets": "The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signing",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "approval",
                            "expected_value": "Ethical Committee (EC)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient, if female, must not be pregnant or lactating at the time of the study",
            "criterions": [
                {
                    "exact_snippets": "Patient, if female, must not be pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient, if female, must not be ... lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease.",
            "criterions": [
                {
                    "exact_snippets": "no history of serious haematologic ... disease",
                    "criterion": "haematologic disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of serious ... cardiovascular ... disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of serious ... liver ... disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of serious ... kidney disease",
                    "criterion": "kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer.",
            "criterions": [
                {
                    "exact_snippets": "no history of previous chemotherapy",
                    "criterion": "previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of previous ... biological therapy",
                    "criterion": "previous biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of previous ... RT for treatment of head and neck cancer",
                    "criterion": "previous RT for treatment of head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must not have an uncontrolled serious infection",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled serious infection",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with organ metastases in liver, bone, brain or lung.",
            "criterions": [
                {
                    "exact_snippets": "organ metastases in liver",
                    "criterion": "organ metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "liver"
                        }
                    ]
                },
                {
                    "exact_snippets": "organ metastases in ... bone",
                    "criterion": "organ metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "bone"
                        }
                    ]
                },
                {
                    "exact_snippets": "organ metastases in ... brain",
                    "criterion": "organ metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "brain"
                        }
                    ]
                },
                {
                    "exact_snippets": "organ metastases in ... lung",
                    "criterion": "organ metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "lung"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}