{
    "info": {
        "nct_id": "NCT06840262",
        "official_title": "Targeted Muscle Reinnervation (TMR) Versus Regenerative Peripheral Nerve Interfaces (RPNI) Versus the Combined Technique of TMR-RPNI to Reduce Chronic and Phantom Limb Pain in Oncologic Amputees: A Randomized Control Pilot Study",
        "inclusion_criteria": "* Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons\n* Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue\n* Patients able to complete informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients under 18 years of age\n* Patients unable to give consent\n* Patients receiving an amputation for non-oncologic purposes\n* Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect\n* Patients with multiple limb amputations\n* Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons",
            "criterions": [
                {
                    "exact_snippets": "greater than or equal to 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving an amputation for oncologic reasons",
                    "criterion": "amputation",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": "oncologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue",
            "criterions": [
                {
                    "exact_snippets": "available mixed major nerves",
                    "criterion": "mixed major nerves",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "available ... donor motor nerves",
                    "criterion": "donor motor nerves",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "amputation stump or reconstructive tissue",
                    "criterion": "location of nerves",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "amputation stump",
                                "reconstructive tissue"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients able to complete informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients able to complete informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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": "* Patients under 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "under 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unable to give consent",
            "criterions": [
                {
                    "exact_snippets": "Patients unable to give consent",
                    "criterion": "ability to give consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving an amputation for non-oncologic purposes",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving an amputation",
                    "criterion": "amputation",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "non-oncologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect",
            "criterions": [
                {
                    "exact_snippets": "amputations performed for immediate palliation",
                    "criterion": "amputation for immediate palliation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy less than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with multiple limb amputations",
            "criterions": [
                {
                    "exact_snippets": "multiple limb amputations",
                    "criterion": "limb amputations",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= 2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving nerve management in a delayed fashion",
                    "criterion": "nerve management",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "delayed"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have previously received an amputation",
                    "criterion": "amputation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "present with neuroma",
                    "criterion": "neuroma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}