{
    "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": [
        {
            "line": "* 18 ≤ age <75 years;",
            "criterions": [
                {
                    "exact_snippets": "18 ≤ age <75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO ≤ 1;",
            "criterions": [
                {
                    "exact_snippets": "WHO ≤ 1",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with cancer and candidate for chemotherapy treatment of first intention;",
            "criterions": [
                {
                    "exact_snippets": "Patients with cancer",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "candidate for chemotherapy treatment of first intention",
                    "criterion": "chemotherapy treatment of first intention",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "solid",
                                "lymphoid"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy is given intravenously",
                    "criterion": "chemotherapy administration route",
                    "requirements": [
                        {
                            "requirement_type": "route",
                            "expected_value": "intravenous"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient affiliated to a social security scheme;",
            "criterions": [
                {
                    "exact_snippets": "Patient affiliated to a social security scheme",
                    "criterion": "social security scheme affiliation",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mastery of the French language;",
            "criterions": [
                {
                    "exact_snippets": "Mastery of the French language",
                    "criterion": "French language",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "mastery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed Consent and signed;",
            "criterions": [
                {
                    "exact_snippets": "Informed Consent and signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the days preceding the first cycle of chemotherapy",
                    "criterion": "timing of paramedical consultation announcement",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "days preceding the first cycle of chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patient deprived of liberty, under guardianship;",
            "criterions": [
                {
                    "exact_snippets": "Patient deprived of liberty",
                    "criterion": "deprivation of liberty",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "under guardianship",
                    "criterion": "guardianship status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "could compromise"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exclusive Oral Chemotherapy;",
            "criterions": [
                {
                    "exact_snippets": "Exclusive Oral Chemotherapy",
                    "criterion": "chemotherapy route",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "oral"
                        },
                        {
                            "requirement_type": "exclusivity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exclusive Targeted therapy;",
            "criterions": [
                {
                    "exact_snippets": "Exclusive Targeted therapy",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "exclusivity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Targeted therapy to be introduced during chemotherapy;",
            "criterions": [
                {
                    "exact_snippets": "Targeted therapy to be introduced during chemotherapy",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of cerebral localization;",
            "criterions": [
                {
                    "exact_snippets": "Presence of cerebral localization",
                    "criterion": "cerebral localization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pain requiring analgesics bearing 3;",
            "criterions": [
                {
                    "exact_snippets": "Pain requiring analgesics",
                    "criterion": "pain",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring analgesics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient in medical and social structure;",
            "criterions": [
                {
                    "exact_snippets": "Patient in medical and social structure",
                    "criterion": "medical and social structure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "geographical, social or psychological reasons",
                    "criterion": "reasons for inability to submit",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "geographical",
                                "social",
                                "psychological"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "soft tissue",
                                "internal organs"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant neuroendocrine tumors sporadic and hereditary",
                    "criterion": "malignant neuroendocrine tumors",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "sporadic",
                                "hereditary"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inclusion in another clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Inclusion in another clinical trial.",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}