{
    "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."
    },
    "inclusion_lines": [
        {
            "line": "1. Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy treatment.",
            "criterions": [
                {
                    "exact_snippets": "CTCAE ≥2 mucositis",
                    "criterion": "mucositis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "during TKI, mTOR inhibitor or immunotherapy treatment",
                    "criterion": "treatment type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "TKI",
                                "mTOR inhibitor",
                                "immunotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Signed written informed consent obtained prior to any study specific procedures.",
            "criterions": [
                {
                    "exact_snippets": "Signed written informed consent obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient must be willing and able to comply with the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be willing",
                    "criterion": "willingness to comply with protocol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to comply with the protocol",
                    "criterion": "ability to comply with protocol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age ≥ 18.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Biopsy proven locally advanced or metastatic renal cell carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Biopsy proven",
                    "criterion": "biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced",
                    "criterion": "renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic renal cell carcinoma",
                    "criterion": "renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.",
            "criterions": [
                {
                    "exact_snippets": "Females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy)",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "postmenopausal",
                                "hysterectomy",
                                "oophorectomy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not lactating"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        },
                        {
                            "requirement_type": "childbearing potential",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since last menstruation",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "men must use effective means of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "men"
                        },
                        {
                            "requirement_type": "contraception use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women ... must use effective means of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "women"
                        },
                        {
                            "requirement_type": "contraception use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Karnofsky Performance status ≥ 60%.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance status ≥ 60%",
                    "criterion": "Karnofsky Performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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. Known hypersensitivity to folic acid.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to folic acid",
                    "criterion": "hypersensitivity to folic acid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Use of prednisolone more than 10 mg daily.",
            "criterions": [
                {
                    "exact_snippets": "Use of prednisolone more than 10 mg daily.",
                    "criterion": "prednisolone use",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "inoperable",
                    "criterion": "operability of renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced",
                    "criterion": "stage of renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic",
                    "criterion": "stage of renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "renal cell carcinoma",
                    "criterion": "type of cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}