{
    "info": {
        "nct_id": "NCT00767273",
        "official_title": "Pilot Study to Investigate the Role of Metabolic Imaging in Predicting Tumor Response and Outcome After Therapy for Pancreatic Cancer",
        "inclusion_criteria": "- Adult patients (>18) with histologically confirmed adenocarcinomas of the pancreas with a - treatment plan consisting of definitive or palliative radiation therapy and/or chemotherapy with or without surgery.\n\n* Negative urine pregnancy test if a woman of child-bearing potential (WOCBP).\n* WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study period.\n* All patients will be evaluated in a uniform manner at the Stanford GI Combined Modality Tumor Board to determine eligibility.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n\n  2. Any concurrent malignancy other than non-melanomaskin cancer, or carcinomainsitu of the cervix. Patients with a previous malignancy without evidence of disease for >5 years will be allowed to enter the trial.\n\n  3. WOCBP who is pregnant or breastfeeding. 4. Inability to sign written consent.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "- Adult patients (>18) with histologically confirmed adenocarcinomas of the pancreas with a - treatment plan consisting of definitive or palliative radiation therapy and/or chemotherapy with or without surgery.",
            "criterions": [
                {
                    "exact_snippets": "Adult patients (>18)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed adenocarcinomas of the pancreas",
                    "criterion": "adenocarcinomas of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment plan consisting of definitive or palliative radiation therapy and/or chemotherapy with or without surgery",
                    "criterion": "treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "components",
                            "expected_value": [
                                "definitive or palliative radiation therapy",
                                "chemotherapy",
                                "surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative urine pregnancy test if a woman of child-bearing potential (WOCBP).",
            "criterions": [
                {
                    "exact_snippets": "Negative urine pregnancy test",
                    "criterion": "urine pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "if a woman of child-bearing potential (WOCBP)",
                    "criterion": "woman of child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study period.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP must be using an adequate method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "WOCBP ... to avoid pregnancy throughout the study period",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "avoidance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients will be evaluated in a uniform manner at the Stanford GI Combined Modality Tumor Board to determine eligibility.",
            "criterions": [
                {
                    "exact_snippets": "evaluated in a uniform manner at the Stanford GI Combined Modality Tumor Board",
                    "criterion": "evaluation at Stanford GI Combined Modality Tumor Board",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would not limit compliance"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. WOCBP who is pregnant or breastfeeding. 4. Inability to sign written consent.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP who is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "WOCBP who is ... breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability to sign written consent",
                    "criterion": "ability to sign written consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "2. Any concurrent malignancy other than non-melanomaskin cancer, or carcinomainsitu of the cervix. Patients with a previous malignancy without evidence of disease for >5 years will be allowed to enter the trial.",
            "criterions": [
                {
                    "exact_snippets": "Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix.",
                    "criterion": "concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with a previous malignancy without evidence of disease for >5 years will be allowed to enter the trial.",
                    "criterion": "previous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "disease-free period",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}