{
    "info": {
        "nct_id": "NCT00316420",
        "official_title": "Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma",
        "inclusion_criteria": "* Metastatic or unresectable pancreatic cancer\n* No prior chemotherapy except radiation-sensitizing doses of 5-FU\n* No radiotherapy less than 4 weeks prior to the start of the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU\n* Moderate to severe renal impairment\n* Uncontrolled diabetes\n* Inability to swallow tablets",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Metastatic or unresectable pancreatic cancer",
            "criterions": [
                {
                    "exact_snippets": "Metastatic ... pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy except radiation-sensitizing doses of 5-FU",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except radiation-sensitizing doses of 5-FU",
                    "criterion": "radiation-sensitizing doses of 5-FU",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No radiotherapy less than 4 weeks prior to the start of the study",
            "criterions": [
                {
                    "exact_snippets": "No radiotherapy less than 4 weeks prior to the start of the study",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU",
            "criterions": [
                {
                    "exact_snippets": "Prior unanticipated severe reaction to fluoropyrimidine therapy",
                    "criterion": "severe reaction to fluoropyrimidine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to 5-FU",
                    "criterion": "hypersensitivity to 5-FU",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Moderate to severe renal impairment",
            "criterions": [
                {
                    "exact_snippets": "Moderate to severe renal impairment",
                    "criterion": "renal impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled diabetes",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to swallow tablets",
            "criterions": [
                {
                    "exact_snippets": "Inability to swallow tablets",
                    "criterion": "ability to swallow tablets",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}