{
    "info": {
        "nct_id": "NCT00297648",
        "official_title": "A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.",
        "inclusion_criteria": "* Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8\n* Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome\n* History of tuberculosis or positive tests for tuberculosis at screening\n* All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient\n* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8",
            "criterions": [
                {
                    "exact_snippets": "Patients suffering from active Crohn's disease",
                    "criterion": "active Crohn's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450",
                    "criterion": "Crohn's Disease Activity Index (CDAI)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 220,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 450,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 2 segments with endoscopic ulcerative lesions",
                    "criterion": "segments with endoscopic ulcerative lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "segments"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8",
                    "criterion": "Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy",
                    "criterion": "anti-tumor necrosis factor (anti-TNF) therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome",
            "criterions": [
                {
                    "exact_snippets": "Obstructive intestinal strictures",
                    "criterion": "obstructive intestinal strictures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bowel resection",
                    "criterion": "bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "proctocolectomy",
                    "criterion": "proctocolectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "total colectomy",
                    "criterion": "total colectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "current total parenteral nutrition",
                    "criterion": "total parenteral nutrition",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "short bowel syndrome",
                    "criterion": "short bowel syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of tuberculosis or positive tests for tuberculosis at screening",
            "criterions": [
                {
                    "exact_snippets": "History of tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive tests for tuberculosis at screening",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient",
            "criterions": [
                {
                    "exact_snippets": "concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment",
                    "criterion": "concomitant diseases or pathological conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with Crohn's disease assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concomitant diseases or pathological conditions ... to be harmful for the well being of the patient",
                    "criterion": "concomitant diseases or pathological conditions",
                    "requirements": [
                        {
                            "requirement_type": "harmfulness to patient well-being",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial",
            "criterions": [
                {
                    "exact_snippets": "Previous clinical trials",
                    "criterion": "previous clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous biological therapy",
                    "criterion": "previous biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}