{
"info": {
"nct_id": "NCT02328560",
"official_title": "Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy",
"inclusion_criteria": "* 18 ≤ age <75 years;\n* WHO ≤ 1;\n* Patients with cancer and candidate for chemotherapy treatment of first intention;\n* Solid or lymphoid malignant disease pathology for which chemotherapy is given intravenously;\n* Patient affiliated to a social security scheme;\n* Mastery of the French language;\n* Informed Consent and signed;\n* In the first cohort, patients will have received paramedical consultation announcement in the days preceding the first cycle of chemotherapy;\n* In the second cohort, patients have not received paramedical consultation announcement.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Patient deprived of liberty, under guardianship;\n* Any medical or psychological condition associated that could compromise the patient's ability to participate in the study;\n* Exclusive Oral Chemotherapy;\n* Exclusive Targeted therapy;\n* Targeted therapy to be introduced during chemotherapy;\n* Presence of cerebral localization;\n* Pain requiring analgesics bearing 3;\n* Patient in medical and social structure;\n* Inability to submit to medical monitoring test for geographical, social or psychological reasons;\n* Rare Cancers making matching difficult (sarcomas of soft tissue and internal organs, malignant neuroendocrine tumors sporadic and hereditary rare ...)\n* Inclusion in another clinical trial.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* 18 ≤ age <75 years;",
"criterions": [
{
"exact_snippets": "18 ≤ age <75 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<",
"value": 75,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "18 ≤ age <75 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<",
"value": 75,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with cancer and candidate for chemotherapy treatment of first intention;",
"criterions": [
{
"exact_snippets": "Patients with cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "candidate for chemotherapy treatment of first intention",
"criterion": "chemotherapy treatment of first intention",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients with cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "candidate for chemotherapy treatment of first intention",
"criterion": "chemotherapy treatment of first intention",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Solid or lymphoid malignant disease pathology for which chemotherapy is given intravenously;",
"criterions": [
{
"exact_snippets": "Solid or lymphoid malignant disease pathology",
"criterion": "malignant disease pathology",
"requirement": {
"requirement_type": "type",
"expected_value": [
"solid",
"lymphoid"
]
}
},
{
"exact_snippets": "chemotherapy is given intravenously",
"criterion": "chemotherapy administration route",
"requirement": {
"requirement_type": "route",
"expected_value": "intravenous"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Solid or lymphoid malignant disease pathology",
"criterion": "malignant disease pathology",
"requirement": {
"requirement_type": "type",
"expected_value": [
"solid",
"lymphoid"
]
}
},
{
"exact_snippets": "chemotherapy is given intravenously",
"criterion": "chemotherapy administration route",
"requirement": {
"requirement_type": "route",
"expected_value": "intravenous"
}
}
]
}
},
{
"identified_line": {
"line": "* Patient affiliated to a social security scheme;",
"criterions": [
{
"exact_snippets": "Patient affiliated to a social security scheme",
"criterion": "social security scheme affiliation",
"requirement": {
"requirement_type": "affiliation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient affiliated to a social security scheme",
"criterion": "social security scheme affiliation",
"requirement": {
"requirement_type": "affiliation",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Mastery of the French language;",
"criterions": [
{
"exact_snippets": "Mastery of the French language",
"criterion": "French language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "mastery"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Mastery of the French language",
"criterion": "French language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "mastery"
}
}
]
}
},
{
"identified_line": {
"line": "* Informed Consent and signed;",
"criterions": [
{
"exact_snippets": "Informed Consent and signed",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Informed Consent and signed",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* In the first cohort, patients will have received paramedical consultation announcement in the days preceding the first cycle of chemotherapy;",
"criterions": [
{
"exact_snippets": "patients will have received paramedical consultation announcement",
"criterion": "paramedical consultation announcement",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "in the days preceding the first cycle of chemotherapy",
"criterion": "timing of paramedical consultation announcement",
"requirement": {
"requirement_type": "timing",
"expected_value": "days preceding the first cycle of chemotherapy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "patients will have received paramedical consultation announcement",
"criterion": "paramedical consultation announcement",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "in the days preceding the first cycle of chemotherapy",
"criterion": "timing of paramedical consultation announcement",
"requirement": {
"requirement_type": "timing",
"expected_value": "days preceding the first cycle of chemotherapy"
}
}
]
}
},
{
"identified_line": {
"line": "* In the second cohort, patients have not received paramedical consultation announcement.",
"criterions": [
{
"exact_snippets": "patients have not received paramedical consultation announcement",
"criterion": "paramedical consultation announcement",
"requirement": {
"requirement_type": "receipt",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "patients have not received paramedical consultation announcement",
"criterion": "paramedical consultation announcement",
"requirement": {
"requirement_type": "receipt",
"expected_value": false
}
}
]
}
},
{
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patient deprived of liberty, under guardianship;",
"criterions": [
{
"exact_snippets": "Patient deprived of liberty",
"criterion": "deprivation of liberty",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "under guardianship",
"criterion": "guardianship status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Patient deprived of liberty",
"criterion": "deprivation of liberty",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "under guardianship",
"criterion": "guardianship status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Any medical or psychological condition associated that could compromise the patient's ability to participate in the study;",
"criterions": [
{
"exact_snippets": "Any medical or psychological condition ... could compromise the patient's ability to participate in the study",
"criterion": "medical or psychological condition",
"requirement": {
"requirement_type": "impact on study participation",
"expected_value": "could compromise"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Any medical or psychological condition ... could compromise the patient's ability to participate in the study",
"criterion": "medical or psychological condition",
"requirement": {
"requirement_type": "impact on study participation",
"expected_value": "could compromise"
}
}
}
},
{
"identified_line": {
"line": "* Exclusive Oral Chemotherapy;",
"criterions": [
{
"exact_snippets": "Exclusive Oral Chemotherapy",
"criterion": "chemotherapy route",
"requirement": {
"requirement_type": "type",
"expected_value": "oral"
}
},
{
"exact_snippets": "Exclusive Oral Chemotherapy",
"criterion": "chemotherapy route",
"requirement": {
"requirement_type": "exclusivity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Exclusive Oral Chemotherapy",
"criterion": "chemotherapy route",
"requirement": {
"requirement_type": "type",
"expected_value": "oral"
}
},
{
"exact_snippets": "Exclusive Oral Chemotherapy",
"criterion": "chemotherapy route",
"requirement": {
"requirement_type": "exclusivity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Exclusive Targeted therapy;",
"criterions": [
{
"exact_snippets": "Exclusive Targeted therapy",
"criterion": "targeted therapy",
"requirement": {
"requirement_type": "exclusivity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Exclusive Targeted therapy",
"criterion": "targeted therapy",
"requirement": {
"requirement_type": "exclusivity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Targeted therapy to be introduced during chemotherapy;",
"criterions": [
{
"exact_snippets": "Targeted therapy to be introduced during chemotherapy",
"criterion": "targeted therapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "during chemotherapy"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Targeted therapy to be introduced during chemotherapy",
"criterion": "targeted therapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "during chemotherapy"
}
}
}
},
{
"identified_line": {
"line": "* Presence of cerebral localization;",
"criterions": [
{
"exact_snippets": "Presence of cerebral localization",
"criterion": "cerebral localization",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Presence of cerebral localization",
"criterion": "cerebral localization",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Pain requiring analgesics bearing 3;",
"criterions": [
{
"exact_snippets": "Pain requiring analgesics",
"criterion": "pain",
"requirement": {
"requirement_type": "severity",
"expected_value": "requiring analgesics"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pain requiring analgesics",
"criterion": "pain",
"requirement": {
"requirement_type": "severity",
"expected_value": "requiring analgesics"
}
}
]
}
},
{
"identified_line": {
"line": "* Patient in medical and social structure;",
"criterions": [
{
"exact_snippets": "Patient in medical and social structure",
"criterion": "medical and social structure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient in medical and social structure",
"criterion": "medical and social structure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Rare Cancers making matching difficult (sarcomas of soft tissue and internal organs, malignant neuroendocrine tumors sporadic and hereditary rare ...)",
"criterions": [
{
"exact_snippets": "sarcomas of soft tissue and internal organs",
"criterion": "sarcomas",
"requirement": {
"requirement_type": "location",
"expected_value": [
"soft tissue",
"internal organs"
]
}
},
{
"exact_snippets": "malignant neuroendocrine tumors sporadic and hereditary",
"criterion": "malignant neuroendocrine tumors",
"requirement": {
"requirement_type": "type",
"expected_value": [
"sporadic",
"hereditary"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "sarcomas of soft tissue and internal organs",
"criterion": "sarcomas",
"requirement": {
"requirement_type": "location",
"expected_value": [
"soft tissue",
"internal organs"
]
}
},
{
"exact_snippets": "malignant neuroendocrine tumors sporadic and hereditary",
"criterion": "malignant neuroendocrine tumors",
"requirement": {
"requirement_type": "type",
"expected_value": [
"sporadic",
"hereditary"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Inclusion in another clinical trial.",
"criterions": [
{
"exact_snippets": "Inclusion in another clinical trial.",
"criterion": "participation in another clinical trial",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Inclusion in another clinical trial.",
"criterion": "participation in another clinical trial",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* WHO ≤ 1;",
"criterions": [
{
"exact_snippets": "WHO ≤ 1",
"criterion": "WHO performance status",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "WHO \u001f 1",
"criterion": "WHO performance status",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Inability to submit to medical monitoring test for geographical, social or psychological reasons;",
"criterions": [
{
"exact_snippets": "Inability to submit to medical monitoring test",
"criterion": "ability to submit to medical monitoring test",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "geographical, social or psychological reasons",
"criterion": "reasons for inability to submit",
"requirement": {
"requirement_type": "type",
"expected_value": [
"geographical",
"social",
"psychological"
]
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Inability to submit to medical monitoring test",
"criterion": "ability to submit to medical monitoring test",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
"then_criteria": {
"or_criteria": [
{
"exact_snippets": "geographical, social or psychological reasons",
"criterion": "reasons for inability to submit",
"requirement": {
"requirement_type": "type",
"expected_value": [
"geographical"
]
}
},
{
"exact_snippets": "geographical, social or psychological reasons",
"criterion": "reasons for inability to submit",
"requirement": {
"requirement_type": "type",
"expected_value": [
"social"
]
}
},
{
"exact_snippets": "geographical, social or psychological reasons",
"criterion": "reasons for inability to submit",
"requirement": {
"requirement_type": "type",
"expected_value": [
"psychological"
]
}
}
]
},
"else_criteria": null
}
}
],
"failed_miscellaneous": []
}