{
    "info": {
        "nct_id": "NCT04973748",
        "official_title": "Open-label Conditioning Therapy for Peri-operative Pain Management in Head and Neck Cancer Patients",
        "inclusion_criteria": "* Patients receiving pre-operative evaluation for head and neck cancer in the Otolaryngology - Head and Neck Surgery Department at Johns Hopkins Hospital\n* Scheduled for surgery for resection of and/or reconstruction following resection of a head and neck tumor between November 15, 2022 - May 15, 2024, with expected inpatient admission of at least 5 days after surgery.\n* Age 18 years or older\n* Ability to comprehend and willingness to participate in open-label conditioning portion of study regardless of study group assignment\n* Ability to participate in study for 1 week prior to surgery and 6 months following surgery at time of enrollment\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Past medical history of substance use disorder\n* Chronic pain (defined as pain lasting >3 months) or chronic opioid use (for >3 months).\n* Contraindication to receiving acetaminophen, ibuprofen, oxycodone, or hydromorphone\n* New gabapentin prescription started <2 weeks prior to surgery\n* Psychosis, delirium or other significant cognitive impairment preventing participation in study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients receiving pre-operative evaluation for head and neck cancer in the Otolaryngology - Head and Neck Surgery Department at Johns Hopkins Hospital",
            "criterions": [
                {
                    "exact_snippets": "pre-operative evaluation",
                    "criterion": "pre-operative evaluation",
                    "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
                        }
                    ]
                },
                {
                    "exact_snippets": "Otolaryngology - Head and Neck Surgery Department",
                    "criterion": "department",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "Otolaryngology - Head and Neck Surgery Department"
                        }
                    ]
                },
                {
                    "exact_snippets": "Johns Hopkins Hospital",
                    "criterion": "hospital",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "Johns Hopkins Hospital"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled for surgery for resection of and/or reconstruction following resection of a head and neck tumor between November 15, 2022 - May 15, 2024, with expected inpatient admission of at least 5 days after surgery.",
            "criterions": [
                {
                    "exact_snippets": "Scheduled for surgery for resection of and/or reconstruction following resection of a head and neck tumor",
                    "criterion": "surgery for head and neck tumor",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "between November 15, 2022 - May 15, 2024",
                    "criterion": "surgery date",
                    "requirements": [
                        {
                            "requirement_type": "date range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2022,
                                        "unit": "year"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2024,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected inpatient admission of at least 5 days after surgery",
                    "criterion": "inpatient admission duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to comprehend and willingness to participate in open-label conditioning portion of study regardless of study group assignment",
            "criterions": [
                {
                    "exact_snippets": "Ability to comprehend",
                    "criterion": "comprehension ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to participate",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "open-label conditioning portion of study",
                    "criterion": "participation in open-label conditioning portion",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "regardless of study group assignment",
                    "criterion": "participation regardless of study group assignment",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to participate in study for 1 week prior to surgery and 6 months following surgery at time of enrollment",
            "criterions": [
                {
                    "exact_snippets": "Ability to participate in study for 1 week prior to surgery and 6 months following surgery",
                    "criterion": "participation duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": [
                                ">= 1 week prior to surgery",
                                "6 months following surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Past medical history of substance use disorder",
            "criterions": [
                {
                    "exact_snippets": "Past medical history of substance use disorder",
                    "criterion": "substance use disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic pain (defined as pain lasting >3 months) or chronic opioid use (for >3 months).",
            "criterions": [
                {
                    "exact_snippets": "Chronic pain (defined as pain lasting >3 months)",
                    "criterion": "chronic pain",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic opioid use (for >3 months)",
                    "criterion": "chronic opioid use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication to receiving acetaminophen, ibuprofen, oxycodone, or hydromorphone",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to receiving acetaminophen",
                    "criterion": "acetaminophen",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindication to receiving ... ibuprofen",
                    "criterion": "ibuprofen",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindication to receiving ... oxycodone",
                    "criterion": "oxycodone",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindication to receiving ... hydromorphone",
                    "criterion": "hydromorphone",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* New gabapentin prescription started <2 weeks prior to surgery",
            "criterions": [
                {
                    "exact_snippets": "New gabapentin prescription started <2 weeks prior to surgery",
                    "criterion": "gabapentin prescription",
                    "requirements": [
                        {
                            "requirement_type": "start time",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "weeks prior to surgery"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Psychosis, delirium or other significant cognitive impairment preventing participation in study",
            "criterions": [
                {
                    "exact_snippets": "Psychosis",
                    "criterion": "psychosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "delirium",
                    "criterion": "delirium",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant cognitive impairment",
                    "criterion": "cognitive impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "impact",
                            "expected_value": "preventing participation in study"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}