{
    "info": {
        "nct_id": "NCT03581773",
        "official_title": "FASTERCC: Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy. A Randomized, Double-blind Trial From the Danish Renal Cancer Group (DARENCA Study-4)",
        "inclusion_criteria": "1. Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy treatment.\n2. Signed written informed consent obtained prior to any study specific procedures.\n3. Patient must be willing and able to comply with the protocol.\n4. Age ≥ 18.\n5. Biopsy proven locally advanced or metastatic renal cell carcinoma.\n6. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.\n7. Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).\n8. Karnofsky Performance status ≥ 60%.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Known hypersensitivity to folic acid.\n2. Use of prednisolone more than 10 mg daily.",
        "miscellaneous_criteria": "Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma."
    },
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                                "value": 18,
                                "unit": "years"
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                    }
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        },
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                        ]
                    }
                ]
            }
        },
        {
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                        "criterion": "gender",
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                            "expected_value": "female"
                        }
                    },
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                        "criterion": "pregnancy test result",
                        "requirement": {
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                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy)",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
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                                "hysterectomy",
                                "oophorectomy"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "not lactating",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "not lactating"
                        }
                    }
                ]
            },
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                        "and_criteria": [
                            {
                                "and_criteria": [
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                                        "and_criteria": [
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                                                    "expected_value": "female"
                                                }
                                            },
                                            {
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                                                "criterion": "pregnancy test result",
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                                                }
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                                    },
                                    {
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                                        "criterion": "lactation status",
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                                        }
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                                            "hysterectomy",
                                            "oophorectomy"
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                                "criterion": "pregnancy test result",
                                "requirement": {
                                    "requirement_type": "result",
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                                }
                            },
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                                "exact_snippets": "childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy)",
                                "criterion": "childbearing potential",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": [
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                                        "hysterectomy",
                                        "oophorectomy"
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                    }
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        },
        {
            "identified_line": {
                "line": "7. Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).",
                "criterions": [
                    {
                        "exact_snippets": "Fertile women of childbearing potential (<2 years after last menstruation)",
                        "criterion": "fertility status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
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                            "expected_value": true
                        }
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                        "exact_snippets": "Fertile women of childbearing potential (<2 years after last menstruation)",
                        "criterion": "fertility status",
                        "requirement": {
                            "requirement_type": "time since last menstruation",
                            "expected_value": {
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                                "value": 2,
                                "unit": "years"
                            }
                        }
                    },
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                        "exact_snippets": "men must use effective means of contraception",
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                        "requirement": {
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                            "expected_value": "men"
                        }
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                        "requirement": {
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                            "expected_value": true
                        }
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                        }
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                                        "criterion": "fertility status",
                                        "requirement": {
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                                            "expected_value": "fertile"
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                                                "unit": "years"
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                                            "expected_value": "women"
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                                "exact_snippets": "men must use effective means of contraception",
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                        "exact_snippets": "Karnofsky Performance status ≥ 60%",
                        "criterion": "Karnofsky Performance status",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
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                        "exact_snippets": "Karnofsky Performance status ≥ 60%",
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        {
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                        "exact_snippets": "minimum age of 18 Years",
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                            "requirement_type": "minimum",
                            "expected_value": {
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                                "value": 18,
                                "unit": "Years"
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                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
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        {
            "identified_line": {
                "line": "1. Known hypersensitivity to folic acid.",
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                    {
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                        "criterion": "hypersensitivity to folic acid",
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                            "requirement_type": "presence",
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                        }
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                    }
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                        "exact_snippets": "Use of prednisolone more than 10 mg daily.",
                        "criterion": "prednisolone use",
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                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily"
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                        "exact_snippets": "Use of prednisolone more than 10 mg daily.",
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                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [
        {
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                            "expected_value": false
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                        "criterion": "stage of renal cell carcinoma",
                        "requirement": {
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                        }
                    },
                    {
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                    },
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                        }
                    }
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                    {
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                                    {
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                                        "criterion": "stage of renal cell carcinoma",
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                                        }
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                                    {
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                        ]
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                ]
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                                "unit": "CTCAE"
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                                        }
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    "failed_exclusion": [],
    "failed_miscellaneous": []
}