{
    "info": {
        "nct_id": "NCT04105582",
        "official_title": "Phase I Clinical Study of Immunotherapy With Personalized Synthetic Vaccines in Patients With Triple Negative Breast Cancer",
        "inclusion_criteria": "* Be a patient who is prescribed as a treatment for her cancer initiating neo-adjuvant chemotherapy with Doxorubicin / cyclophosphamide (A / C) administered prior to cycles with Taxanes and followed by surgery to remove the tumor.\n* Be between 18 and 75 years old.\n* That the patient agrees to participate in the Clinical Study prior to the start of chemotherapy.\n* Have free venous access.\n* Signature of informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Heart disease.\n* Diabetes\n* Renal impairment\n* Coagulation disorders\n* Have been hospitalized in the last month\n* Have another active tumor with the exception of skin tumors of the squamous-cell or basal-cell carcinoma.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Be a patient who is prescribed as a treatment for her cancer initiating neo-adjuvant chemotherapy with Doxorubicin / cyclophosphamide (A / C) administered prior to cycles with Taxanes and followed by surgery to remove the tumor.",
            "criterions": [
                {
                    "exact_snippets": "prescribed as a treatment for her cancer",
                    "criterion": "cancer treatment prescription",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "neo-adjuvant chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "initiating neo-adjuvant chemotherapy with Doxorubicin / cyclophosphamide (A / C)",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "regimen",
                            "expected_value": [
                                "Doxorubicin",
                                "cyclophosphamide"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "administered prior to cycles with Taxanes",
                    "criterion": "chemotherapy sequence",
                    "requirements": [
                        {
                            "requirement_type": "sequence",
                            "expected_value": "prior to Taxanes"
                        }
                    ]
                },
                {
                    "exact_snippets": "followed by surgery to remove the tumor",
                    "criterion": "treatment sequence",
                    "requirements": [
                        {
                            "requirement_type": "sequence",
                            "expected_value": "followed by surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be between 18 and 75 years old.",
            "criterions": [
                {
                    "exact_snippets": "Be between 18 and 75 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* That the patient agrees to participate in the Clinical Study prior to the start of chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "patient agrees to participate in the Clinical Study",
                    "criterion": "consent to participate",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have free venous access.",
            "criterions": [
                {
                    "exact_snippets": "Have free venous access.",
                    "criterion": "venous access",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signature of informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Signature of informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Heart disease.",
            "criterions": [
                {
                    "exact_snippets": "Heart disease.",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diabetes",
            "criterions": [
                {
                    "exact_snippets": "Diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal impairment",
            "criterions": [
                {
                    "exact_snippets": "Renal impairment",
                    "criterion": "renal impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Coagulation disorders",
            "criterions": [
                {
                    "exact_snippets": "Coagulation disorders",
                    "criterion": "coagulation disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have been hospitalized in the last month",
            "criterions": [
                {
                    "exact_snippets": "Have been hospitalized in the last month",
                    "criterion": "hospitalization",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "last month"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have another active tumor with the exception of skin tumors of the squamous-cell or basal-cell carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Have another active tumor",
                    "criterion": "active tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of skin tumors of the squamous-cell or basal-cell carcinoma",
                    "criterion": "skin tumors of the squamous-cell or basal-cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}