{
"info": {
"nct_id": "NCT04683172",
"official_title": "Efficacy Assessment of Transcranial Direct Current STIMulation (tDCS) in Reducing Pain in PALliative Cancer Patients.",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Inclusion criteria\n\n1. Patient with a confirmed cancer at a palliative stage\n2. Pain whose mean intensity is greater than or equal to 4/10 in the 48 hours preceding inclusion\n3. Pain present on a daily or almost daily basis (at least 4 days out of 7)\n4. Pain that has been present for at least 48 hours before inclusion\n5. Patients aged 18 or over\n6. Patients who can be followed for the duration of the study (i.e. 3 weeks)\n7. Patients affiliated to a health insurance plan or entitled\n8. Life expectancy estimated at more than 3 weeks\n9. Agreeing to participate in the study and having signed an informed consent\n\nExclusion criteria\n\n1. Inability to self-assess pain and complete self-questionnaires\n2. History of head trauma or neurosurgical injury\n3. Symptomatic intracranial hypertension (HTIC)\n4. Uncontrolled epilepsy\n5. Impossibility to correctly positioning the medical device\n6. Abuse of drugs or psychoactive substances, at the discretion of the investigator\n7. Current major depression or psychosis\n8. Pregnant or breastfeeding woman\n9. Patient already included in a research protocol on pain\n10. Patient under legal protection\n11. Absence of affiliation to a social security scheme\n12. Specific contraindication to tDCS (intracerebral metal implant)\n13. Patients deprived of liberty\n14. Patients undergoing psychiatric care."
},
"inclusion_lines": [
{
"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": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "1. Patient with a confirmed cancer at a palliative stage",
"criterions": [
{
"exact_snippets": "confirmed cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "palliative stage",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "palliative"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "confirmed cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "palliative stage",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "palliative"
}
}
]
}
},
{
"identified_line": {
"line": "2. Pain whose mean intensity is greater than or equal to 4/10 in the 48 hours preceding inclusion",
"criterions": [
{
"exact_snippets": "Pain whose mean intensity is greater than or equal to 4/10",
"criterion": "pain intensity",
"requirement": {
"requirement_type": "mean intensity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "10"
}
}
},
{
"exact_snippets": "in the 48 hours preceding inclusion",
"criterion": "time frame for pain assessment",
"requirement": {
"requirement_type": "time frame",
"expected_value": "48 hours preceding inclusion"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pain whose mean intensity is greater than or equal to 4/10",
"criterion": "pain intensity",
"requirement": {
"requirement_type": "mean intensity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "10"
}
}
},
{
"exact_snippets": "in the 48 hours preceding inclusion",
"criterion": "time frame for pain assessment",
"requirement": {
"requirement_type": "time frame",
"expected_value": "48 hours preceding inclusion"
}
}
]
}
},
{
"identified_line": {
"line": "3. Pain present on a daily or almost daily basis (at least 4 days out of 7)",
"criterions": [
{
"exact_snippets": "Pain present on a daily or almost daily basis (at least 4 days out of 7)",
"criterion": "pain",
"requirement": {
"requirement_type": "frequency",
"expected_value": "daily or almost daily (at least 4 days out of 7)"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pain present on a daily or almost daily basis (at least 4 days out of 7)",
"criterion": "pain",
"requirement": {
"requirement_type": "frequency",
"expected_value": "daily or almost daily (at least 4 days out of 7)"
}
}
]
}
},
{
"identified_line": {
"line": "4. Pain that has been present for at least 48 hours before inclusion",
"criterions": [
{
"exact_snippets": "Pain that has been present for at least 48 hours",
"criterion": "pain duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 48,
"unit": "hours"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pain that has been present for at least 48 hours",
"criterion": "pain duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 48,
"unit": "hours"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. History of head trauma or neurosurgical injury",
"criterions": [
{
"exact_snippets": "History of head trauma",
"criterion": "head trauma",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... neurosurgical injury",
"criterion": "neurosurgical injury",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of head trauma",
"criterion": "head trauma",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... neurosurgical injury",
"criterion": "neurosurgical injury",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Symptomatic intracranial hypertension (HTIC)",
"criterions": [
{
"exact_snippets": "Symptomatic intracranial hypertension (HTIC)",
"criterion": "intracranial hypertension",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Symptomatic intracranial hypertension (HTIC)",
"criterion": "intracranial hypertension",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. Impossibility to correctly positioning the medical device",
"criterions": [
{
"exact_snippets": "Impossibility to correctly positioning the medical device",
"criterion": "positioning of the medical device",
"requirement": {
"requirement_type": "possibility",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Impossibility to correctly positioning the medical device",
"criterion": "positioning of the medical device",
"requirement": {
"requirement_type": "possibility",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "6. Abuse of drugs or psychoactive substances, at the discretion of the investigator",
"criterions": [
{
"exact_snippets": "Abuse of drugs or psychoactive substances",
"criterion": "abuse of drugs or psychoactive substances",
"requirement": {
"requirement_type": "discretion",
"expected_value": "investigator"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Abuse of drugs or psychoactive substances",
"criterion": "abuse of drugs or psychoactive substances",
"requirement": {
"requirement_type": "discretion",
"expected_value": "investigator"
}
}
]
}
},
{
"identified_line": {
"line": "7. Current major depression or psychosis",
"criterions": [
{
"exact_snippets": "Current major depression",
"criterion": "major depression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "psychosis",
"criterion": "psychosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Current major depression",
"criterion": "major depression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "psychosis",
"criterion": "psychosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "8. Pregnant or breastfeeding woman",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "9. Patient already included in a research protocol on pain",
"criterions": [
{
"exact_snippets": "Patient already included in a research protocol on pain",
"criterion": "inclusion in a research protocol on pain",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient already included in a research protocol on pain",
"criterion": "inclusion in a research protocol on pain",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "10. Patient under legal protection",
"criterions": [
{
"exact_snippets": "Patient under legal protection",
"criterion": "legal protection status",
"requirement": {
"requirement_type": "status",
"expected_value": "under legal protection"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patient under legal protection",
"criterion": "legal protection status",
"requirement": {
"requirement_type": "status",
"expected_value": "under legal protection"
}
}
}
},
{
"identified_line": {
"line": "11. Absence of affiliation to a social security scheme",
"criterions": [
{
"exact_snippets": "Absence of affiliation to a social security scheme",
"criterion": "affiliation to a social security scheme",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absence of affiliation to a social security scheme",
"criterion": "affiliation to a social security scheme",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "12. Specific contraindication to tDCS (intracerebral metal implant)",
"criterions": [
{
"exact_snippets": "Specific contraindication to tDCS (intracerebral metal implant)",
"criterion": "intracerebral metal implant",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Specific contraindication to tDCS (intracerebral metal implant)",
"criterion": "intracerebral metal implant",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "13. Patients deprived of liberty",
"criterions": [
{
"exact_snippets": "Patients deprived of liberty",
"criterion": "liberty status",
"requirement": {
"requirement_type": "status",
"expected_value": "deprived"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients deprived of liberty",
"criterion": "liberty status",
"requirement": {
"requirement_type": "status",
"expected_value": "deprived"
}
}
}
},
{
"identified_line": {
"line": "14. Patients undergoing psychiatric care.",
"criterions": [
{
"exact_snippets": "Patients undergoing psychiatric care",
"criterion": "psychiatric care",
"requirement": {
"requirement_type": "undergoing",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients undergoing psychiatric care",
"criterion": "psychiatric care",
"requirement": {
"requirement_type": "undergoing",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Inclusion criteria",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Exclusion criteria",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "5. Patients aged 18 or over",
"criterions": [
{
"exact_snippets": "Patients aged 18 or over",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "6. Patients who can be followed for the duration of the study (i.e. 3 weeks)",
"criterions": [
{
"exact_snippets": "Patients who can be followed for the duration of the study (i.e. 3 weeks)",
"criterion": "follow-up duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "7. Patients affiliated to a health insurance plan or entitled",
"criterions": [
{
"exact_snippets": "Patients affiliated to a health insurance plan",
"criterion": "health insurance plan affiliation",
"requirement": {
"requirement_type": "affiliation",
"expected_value": true
}
},
{
"exact_snippets": "entitled",
"criterion": "entitlement to health insurance",
"requirement": {
"requirement_type": "entitlement",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "8. Life expectancy estimated at more than 3 weeks",
"criterions": [
{
"exact_snippets": "Life expectancy estimated at more than 3 weeks",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "estimate",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "9. Agreeing to participate in the study and having signed an informed consent",
"criterions": [
{
"exact_snippets": "Agreeing to participate in the study",
"criterion": "participation agreement",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "having signed an informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "1. Inability to self-assess pain and complete self-questionnaires",
"criterions": [
{
"exact_snippets": "Inability to self-assess pain",
"criterion": "self-assessment of pain",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Inability to ... complete self-questionnaires",
"criterion": "completion of self-questionnaires",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Inability to self-assess pain",
"criterion": "self-assessment of pain",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "Inability to ... complete self-questionnaires",
"criterion": "completion of self-questionnaires",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "4. Uncontrolled epilepsy",
"criterions": [
{
"exact_snippets": "Uncontrolled epilepsy",
"criterion": "epilepsy",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Uncontrolled epilepsy",
"criterion": "epilepsy",
"requirement": {
"requirement_type": "control",
"expected_value": "controlled"
}
}
}
}
]
}