{
    "info": {
        "nct_id": "NCT06749301",
        "official_title": "Repeatability and Reproducibility of the ADC Map in Head and Neck Cancer. Prospective Multicenter Study",
        "inclusion_criteria": "* age over 18 years;\n* primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity; confirmed by histology;\n* a lesion visible on at least three consecutive DWI images, with a minimum diameter of 2 cm;\n* specific written informed consent;\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* incomplete acquisition of DWI images;\n* presence of artifacts that do not allow quantitative analysis of DWI images;\n* performance status 2 or more according to Zubrod.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* age over 18 years;",
            "criterions": [
                {
                    "exact_snippets": "age over 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity; confirmed by histology;",
            "criterions": [
                {
                    "exact_snippets": "primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity",
                    "criterion": "primary squamous cell carcinoma (SCC)",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "hypopharynx",
                                "oropharynx",
                                "oral cavity"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by histology",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* a lesion visible on at least three consecutive DWI images, with a minimum diameter of 2 cm;",
            "criterions": [
                {
                    "exact_snippets": "a lesion visible on at least three consecutive DWI images",
                    "criterion": "lesion visibility on DWI images",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "images"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "a lesion ... with a minimum diameter of 2 cm",
                    "criterion": "lesion diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* specific written informed consent;",
            "criterions": [
                {
                    "exact_snippets": "specific written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "specific written"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* incomplete acquisition of DWI images;",
            "criterions": [
                {
                    "exact_snippets": "incomplete acquisition of DWI images",
                    "criterion": "DWI image acquisition",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* presence of artifacts that do not allow quantitative analysis of DWI images;",
            "criterions": [
                {
                    "exact_snippets": "presence of artifacts that do not allow quantitative analysis of DWI images",
                    "criterion": "artifacts in DWI images",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* performance status 2 or more according to Zubrod.",
            "criterions": [
                {
                    "exact_snippets": "performance status 2 or more according to Zubrod",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Zubrod"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}