{
    "info": {
        "nct_id": "NCT00561548",
        "official_title": "Impact of Anti-TNF Antibodies on the T-lymphocyte and Macrophage Cooperation in the Crohn Disease",
        "inclusion_criteria": "* patient older than 18\n* social security\n* active Crohn disease defined by a CDAI > 250\n* sigmoïdal and/or rectal lesions\n* requiring treatment by infliximab\n* having never received any anti-TNF treatment\n* a negative pregnancy test for women\n* prescription of efficient contraception for women, having started at least a month before beginning the study, and throughout the duration of the study\n* acceptance to participate in this research and having signed the consent form\n* not participating in any other study\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* consent withdrawal\n* the halt of infliximab treatment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* patient older than 18",
            "criterions": [
                {
                    "exact_snippets": "patient older than 18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* social security",
            "criterions": [
                {
                    "exact_snippets": "social security",
                    "criterion": "social security",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* active Crohn disease defined by a CDAI > 250",
            "criterions": [
                {
                    "exact_snippets": "active Crohn disease",
                    "criterion": "Crohn disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "CDAI > 250",
                    "criterion": "CDAI",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 250,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* sigmoïdal and/or rectal lesions",
            "criterions": [
                {
                    "exact_snippets": "sigmoïdal ... lesions",
                    "criterion": "sigmoïdal lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rectal lesions",
                    "criterion": "rectal lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* requiring treatment by infliximab",
            "criterions": [
                {
                    "exact_snippets": "requiring treatment by infliximab",
                    "criterion": "treatment by infliximab",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* having never received any anti-TNF treatment",
            "criterions": [
                {
                    "exact_snippets": "having never received any anti-TNF treatment",
                    "criterion": "anti-TNF treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "never received"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* a negative pregnancy test for women",
            "criterions": [
                {
                    "exact_snippets": "negative pregnancy test for women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prescription of efficient contraception for women, having started at least a month before beginning the study, and throughout the duration of the study",
            "criterions": [
                {
                    "exact_snippets": "prescription of efficient contraception for women",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "prescription",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "having started at least a month before beginning the study",
                    "criterion": "contraception start time",
                    "requirements": [
                        {
                            "requirement_type": "time before study",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "throughout the duration of the study",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* acceptance to participate in this research and having signed the consent form",
            "criterions": [
                {
                    "exact_snippets": "acceptance to participate in this research",
                    "criterion": "acceptance to participate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "having signed the consent form",
                    "criterion": "signed consent form",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* not participating in any other study",
            "criterions": [
                {
                    "exact_snippets": "not participating in any other study",
                    "criterion": "participation in other studies",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* consent withdrawal",
            "criterions": [
                {
                    "exact_snippets": "consent withdrawal",
                    "criterion": "consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "withdrawn"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* the halt of infliximab treatment",
            "criterions": [
                {
                    "exact_snippets": "halt of infliximab treatment",
                    "criterion": "infliximab treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "halted"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}