{
    "info": {
        "nct_id": "NCT01209962",
        "official_title": "A Pilot Study of Diffusion MRI in the Assessment of Pancreatic Tumor Response",
        "inclusion_criteria": "* Patients with histologic or cytologic proof of pancreatic cancer, for whom the treatment plan, at the time of enrollment, is neoadjuvant chemoradiotherapy followed by surgical resection.\n* Patients must be >18 years old.\n* Patients cannot weight over 300 pounds, the weight limit of the MRI table.\n* Patients must have adequate renal function (estimated glomerular filtration rate > 60 mL/min/m2), to minimize the small risk of nephrogenic systemic sclerosis associated with gadolinium injection.\n* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of UM hospital.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients must have no previous radiation to the abdomen.\n* Patients who are pregnant or lactating are excluded.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with histologic or cytologic proof of pancreatic cancer, for whom the treatment plan, at the time of enrollment, is neoadjuvant chemoradiotherapy followed by surgical resection.",
            "criterions": [
                {
                    "exact_snippets": "histologic or cytologic proof of pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "proof",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment plan, at the time of enrollment, is neoadjuvant chemoradiotherapy",
                    "criterion": "treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "neoadjuvant chemoradiotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment plan, at the time of enrollment, is ... followed by surgical resection",
                    "criterion": "treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "sequence",
                            "expected_value": "followed by surgical resection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be >18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be >18 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients cannot weight over 300 pounds, the weight limit of the MRI table.",
            "criterions": [
                {
                    "exact_snippets": "Patients cannot weight over 300 pounds",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 300,
                                "unit": "pounds"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequate renal function (estimated glomerular filtration rate > 60 mL/min/m2), to minimize the small risk of nephrogenic systemic sclerosis associated with gadolinium injection.",
            "criterions": [
                {
                    "exact_snippets": "adequate renal function (estimated glomerular filtration rate > 60 mL/min/m2)",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "estimated glomerular filtration rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of UM hospital.",
            "criterions": [
                {
                    "exact_snippets": "Patients must sign an informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating that they are aware of the investigational nature of this study",
                    "criterion": "awareness of investigational nature",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in keeping with the policies of UM hospital",
                    "criterion": "compliance with UM hospital policies",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "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": "* Patients must have no previous radiation to the abdomen.",
            "criterions": [
                {
                    "exact_snippets": "no previous radiation to the abdomen",
                    "criterion": "previous radiation to the abdomen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are pregnant or lactating are excluded.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}