{
"info": {
"nct_id": "NCT04585620",
"official_title": "Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery: a Randomized Controlled Pilot Trial",
"inclusion_criteria": "1. Patients of 18 years of age or above.\n2. Patients who have undergone pulmonary surgery because of suspicion or confirmed pulmonary malignancies.\n3. Patients who are radically treated for pulmonary malignancy\n4. Patients who suffers from chronic pain or unpleasant sensation at the site of scar at least six months after surgery with fully healed surgical wounds.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Patients who cannot understand oral and written information.\n2. Patients who were not radically operated.\n3. Patients with other concomitant or other active cancer diseases.\n4. Patients with chronic pain in the chest wall prior to surgery.\n5. Pregnant women or women planning to get pregnant in the study period.\n6. Patients with autoimmune neuromuscular diseases, sclerosis, peripheral neuromuscular disturbances and general muscle weakness or atrophy.\n7. Patients with intolerance or allergy to BOTOX®.\n8. Patients who are at present treated with BTX-A or similar neuromuscular blocking drug or have received such in the past year.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Patients of 18 years of age or above.",
"criterions": [
{
"exact_snippets": "Patients of 18 years of age or above.",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "2. Patients who have undergone pulmonary surgery because of suspicion or confirmed pulmonary malignancies.",
"criterions": [
{
"exact_snippets": "undergone pulmonary surgery",
"criterion": "pulmonary surgery",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "suspicion or confirmed pulmonary malignancies",
"criterion": "pulmonary malignancies",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"suspicion",
"confirmed"
]
}
]
}
]
},
{
"line": "3. Patients who are radically treated for pulmonary malignancy",
"criterions": [
{
"exact_snippets": "radically treated for pulmonary malignancy",
"criterion": "pulmonary malignancy",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": "radical"
}
]
}
]
},
{
"line": "4. Patients who suffers from chronic pain or unpleasant sensation at the site of scar at least six months after surgery with fully healed surgical wounds.",
"criterions": [
{
"exact_snippets": "chronic pain or unpleasant sensation at the site of scar",
"criterion": "pain or unpleasant sensation at scar site",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "at least six months after surgery",
"criterion": "time since surgery",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
},
{
"exact_snippets": "fully healed surgical wounds",
"criterion": "surgical wound healing",
"requirements": [
{
"requirement_type": "status",
"expected_value": "fully healed"
}
]
}
]
},
{
"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": "1. Patients who cannot understand oral and written information.",
"criterions": [
{
"exact_snippets": "Patients who cannot understand oral and written information.",
"criterion": "understanding of oral and written information",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "2. Patients who were not radically operated.",
"criterions": [
{
"exact_snippets": "Patients who were not radically operated",
"criterion": "radical operation",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "3. Patients with other concomitant or other active cancer diseases.",
"criterions": [
{
"exact_snippets": "Patients with other concomitant or other active cancer diseases",
"criterion": "concomitant cancer diseases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Patients with other concomitant or other active cancer diseases",
"criterion": "active cancer diseases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "4. Patients with chronic pain in the chest wall prior to surgery.",
"criterions": [
{
"exact_snippets": "chronic pain in the chest wall",
"criterion": "chronic pain in the chest wall",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "prior to surgery",
"criterion": "timing of chronic pain",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "prior to surgery"
}
]
}
]
},
{
"line": "5. Pregnant women or women planning to get pregnant in the study period.",
"criterions": [
{
"exact_snippets": "Pregnant women",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "women planning to get pregnant",
"criterion": "pregnancy intention",
"requirements": [
{
"requirement_type": "intention",
"expected_value": false
}
]
}
]
},
{
"line": "6. Patients with autoimmune neuromuscular diseases, sclerosis, peripheral neuromuscular disturbances and general muscle weakness or atrophy.",
"criterions": [
{
"exact_snippets": "autoimmune neuromuscular diseases",
"criterion": "autoimmune neuromuscular diseases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "sclerosis",
"criterion": "sclerosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "peripheral neuromuscular disturbances",
"criterion": "peripheral neuromuscular disturbances",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "general muscle weakness",
"criterion": "general muscle weakness",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "atrophy",
"criterion": "atrophy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "7. Patients with intolerance or allergy to BOTOX®.",
"criterions": [
{
"exact_snippets": "intolerance or allergy to BOTOX®",
"criterion": "BOTOX®",
"requirements": [
{
"requirement_type": "intolerance",
"expected_value": true
},
{
"requirement_type": "allergy",
"expected_value": true
}
]
}
]
},
{
"line": "8. Patients who are at present treated with BTX-A or similar neuromuscular blocking drug or have received such in the past year.",
"criterions": [
{
"exact_snippets": "Patients who are at present treated with BTX-A or similar neuromuscular blocking drug",
"criterion": "current treatment with neuromuscular blocking drug",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "have received such in the past year",
"criterion": "past treatment with neuromuscular blocking drug",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "past year"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}