{
    "info": {
        "nct_id": "NCT00656760",
        "official_title": "The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of Neck Nodes With an Unknown Primary Malignancy.",
        "inclusion_criteria": "* Age > 18 years old\n* Biopsy proven SCC in a cervical lymph node\n* Unknown primary cancer after: History, Physical exam, and office endoscopy by otolaryngologist\n* Negative Chest X-Ray for malignancy\n* Patient consent signed to undergo investigative protocol\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Un-fit for general anesthesia\n* Unable to lie flat for 45 minutes\n* Unable to fast for > 6 hours\n* Unable to perform PET-CT (Obesity > 150kg)\n* Pregnant\n* Prior Head and Neck cancer\n* Any invasive cancer (Non-Head and Neck) within the last 2 years",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age > 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy proven SCC in a cervical lymph node",
            "criterions": [
                {
                    "exact_snippets": "Biopsy proven SCC",
                    "criterion": "squamous cell carcinoma (SCC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical lymph node",
                    "criterion": "cervical lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unknown primary cancer after: History, Physical exam, and office endoscopy by otolaryngologist",
            "criterions": [
                {
                    "exact_snippets": "Unknown primary cancer",
                    "criterion": "primary cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "unknown"
                        }
                    ]
                },
                {
                    "exact_snippets": "History",
                    "criterion": "history",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Physical exam",
                    "criterion": "physical exam",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "office endoscopy by otolaryngologist",
                    "criterion": "office endoscopy by otolaryngologist",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative Chest X-Ray for malignancy",
            "criterions": [
                {
                    "exact_snippets": "Negative Chest X-Ray for malignancy",
                    "criterion": "chest X-ray",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative for malignancy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient consent signed to undergo investigative protocol",
            "criterions": [
                {
                    "exact_snippets": "Patient consent signed",
                    "criterion": "patient consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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": "* Un-fit for general anesthesia",
            "criterions": [
                {
                    "exact_snippets": "Un-fit for general anesthesia",
                    "criterion": "general anesthesia fitness",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to lie flat for 45 minutes",
            "criterions": [
                {
                    "exact_snippets": "Unable to lie flat for 45 minutes",
                    "criterion": "ability to lie flat",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 45,
                                "unit": "minutes"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to fast for > 6 hours",
            "criterions": [
                {
                    "exact_snippets": "Unable to fast for > 6 hours",
                    "criterion": "fasting ability",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to perform PET-CT (Obesity > 150kg)",
            "criterions": [
                {
                    "exact_snippets": "Unable to perform PET-CT",
                    "criterion": "PET-CT performance",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Obesity > 150kg",
                    "criterion": "obesity",
                    "requirements": [
                        {
                            "requirement_type": "weight",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior Head and Neck cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior Head and Neck cancer",
                    "criterion": "Head and Neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any invasive cancer (Non-Head and Neck) within the last 2 years",
            "criterions": [
                {
                    "exact_snippets": "Any invasive cancer (Non-Head and Neck) within the last 2 years",
                    "criterion": "invasive cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-Head and Neck",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "Head and Neck"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}