{
"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": [
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "receiving an amputation for oncologic reasons",
"criterion": "amputation",
"requirement": {
"requirement_type": "reason",
"expected_value": "oncologic"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "greater than or equal to 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "receiving an amputation for oncologic reasons",
"criterion": "amputation",
"requirement": {
"requirement_type": "reason",
"expected_value": "oncologic"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients able to complete informed consent",
"criterions": [
{
"exact_snippets": "Patients able to complete informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients able to complete informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients under 18 years of age",
"criterions": [
{
"exact_snippets": "under 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "under 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients unable to give consent",
"criterions": [
{
"exact_snippets": "Patients unable to give consent",
"criterion": "ability to give consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients unable to give consent",
"criterion": "ability to give consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patients receiving an amputation for non-oncologic purposes",
"criterions": [
{
"exact_snippets": "Patients receiving an amputation",
"criterion": "amputation",
"requirement": {
"requirement_type": "purpose",
"expected_value": "non-oncologic"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients receiving an amputation",
"criterion": "amputation",
"requirement": {
"requirement_type": "purpose",
"expected_value": "non-oncologic"
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "life expectancy less than 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "amputations performed for immediate palliation",
"criterion": "amputation for immediate palliation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"exact_snippets": "life expectancy less than 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with multiple limb amputations",
"criterions": [
{
"exact_snippets": "multiple limb amputations",
"criterion": "limb amputations",
"requirement": {
"requirement_type": "quantity",
"expected_value": ">= 2"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "multiple limb amputations",
"criterion": "limb amputations",
"requirement": {
"requirement_type": "quantity",
"expected_value": ">= 2"
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "timing",
"expected_value": "delayed"
}
},
{
"exact_snippets": "patients who have previously received an amputation",
"criterion": "amputation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "present with neuroma",
"criterion": "neuroma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients receiving nerve management in a delayed fashion",
"criterion": "nerve management",
"requirement": {
"requirement_type": "timing",
"expected_value": "delayed"
}
},
{
"exact_snippets": "patients who have previously received an amputation",
"criterion": "amputation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "present with neuroma",
"criterion": "neuroma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "available ... donor motor nerves",
"criterion": "donor motor nerves",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "amputation stump or reconstructive tissue",
"criterion": "location of nerves",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"amputation stump",
"reconstructive tissue"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "available mixed major nerves",
"criterion": "mixed major nerves",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "available ... donor motor nerves",
"criterion": "donor motor nerves",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "amputation stump or reconstructive tissue",
"criterion": "location of nerves",
"requirement": {
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"expected_value": "amputation stump"
}
},
{
"exact_snippets": "amputation stump or reconstructive tissue",
"criterion": "location of nerves",
"requirement": {
"requirement_type": "presence",
"expected_value": "reconstructive tissue"
}
}
]
}
]
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}