{
    "info": {
        "nct_id": "NCT05156060",
        "official_title": "Phase I/II Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation",
        "inclusion_criteria": "* Histologically proven cancer of the head and neck cancer\n* Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)\n* Planned primary or adjuvant radiation or chemoradiation therapy\n* Willing and able to provide informed consent\n* ECOG PS 0-2\n* Age ≥ 21 years\n* English speaking\nHealthy volunteers allowed\nMust have minimum age of 21 Years",
        "exclusion_criteria": "* Currently on gabapentin or ketamine\n* Prior non-tolerance of gabapentin or ketamine\n* Unable to administer ketamine intranasally due to anatomical restrictions\n* History of seizure disorder\n* History of schizophrenia\n* History of increased intracranial pressure\n* Glomerular filtration rate <30 mL/min/1.73 m2",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically proven cancer of the head and neck cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven cancer of the head and neck",
                    "criterion": "head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologically proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T3N0M0",
                                "T4N0M0",
                                "T1-4N1-3M0"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planned primary or adjuvant radiation or chemoradiation therapy",
            "criterions": [
                {
                    "exact_snippets": "Planned primary or adjuvant radiation",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "primary",
                                "adjuvant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Planned primary or adjuvant ... chemoradiation therapy",
                    "criterion": "chemoradiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "primary",
                                "adjuvant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG PS 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 21 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 21 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* English speaking",
            "criterions": [
                {
                    "exact_snippets": "English speaking",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "English"
                        }
                    ]
                }
            ]
        },
        {
            "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 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Currently on gabapentin or ketamine",
            "criterions": [
                {
                    "exact_snippets": "Currently on gabapentin",
                    "criterion": "gabapentin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently on ... ketamine",
                    "criterion": "ketamine use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior non-tolerance of gabapentin or ketamine",
            "criterions": [
                {
                    "exact_snippets": "Prior non-tolerance of gabapentin",
                    "criterion": "gabapentin tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior non-tolerance of ... ketamine",
                    "criterion": "ketamine tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to administer ketamine intranasally due to anatomical restrictions",
            "criterions": [
                {
                    "exact_snippets": "Unable to administer ketamine intranasally due to anatomical restrictions",
                    "criterion": "ketamine administration",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "intranasal"
                        },
                        {
                            "requirement_type": "feasibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of seizure disorder",
            "criterions": [
                {
                    "exact_snippets": "History of seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of schizophrenia",
            "criterions": [
                {
                    "exact_snippets": "History of schizophrenia",
                    "criterion": "schizophrenia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of increased intracranial pressure",
            "criterions": [
                {
                    "exact_snippets": "History of increased intracranial pressure",
                    "criterion": "intracranial pressure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "increased"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Glomerular filtration rate <30 mL/min/1.73 m2",
            "criterions": [
                {
                    "exact_snippets": "Glomerular filtration rate <30 mL/min/1.73 m2",
                    "criterion": "glomerular filtration rate",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "mL/min/1.73 m2"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}