{
    "info": {
        "nct_id": "NCT01458457",
        "official_title": "Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study",
        "inclusion_criteria": "* diagnosed breast cancer\n* current usual care treatment\n* willing to refrain from complementary treatment for 6 months in case of randomization into the usual care group\n* informed consent\nHealthy volunteers allowed\nMust be FEMALE",
        "exclusion_criteria": "* complementary treatment at the Hospital Meran in the last 6 months\n* no German or Italian language ability\n* participation in other study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* diagnosed breast cancer",
            "criterions": [
                {
                    "exact_snippets": "diagnosed breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* current usual care treatment",
            "criterions": [
                {
                    "exact_snippets": "current usual care treatment",
                    "criterion": "usual care treatment",
                    "requirements": [
                        {
                            "requirement_type": "current",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* willing to refrain from complementary treatment for 6 months in case of randomization into the usual care group",
            "criterions": [
                {
                    "exact_snippets": "willing to refrain from complementary treatment",
                    "criterion": "willingness to refrain from complementary treatment",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "6 months",
                    "criterion": "duration of refraining from complementary treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "randomization into the usual care group",
                    "criterion": "randomization into the usual care group",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "randomization into the usual care group"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* informed consent",
            "criterions": [
                {
                    "exact_snippets": "informed consent",
                    "criterion": "informed consent",
                    "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* complementary treatment at the Hospital Meran in the last 6 months",
            "criterions": [
                {
                    "exact_snippets": "complementary treatment at the Hospital Meran in the last 6 months",
                    "criterion": "complementary treatment at the Hospital Meran",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* no German or Italian language ability",
            "criterions": [
                {
                    "exact_snippets": "no German ... language ability",
                    "criterion": "German language ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no ... Italian language ability",
                    "criterion": "Italian language ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* participation in other study",
            "criterions": [
                {
                    "exact_snippets": "participation in other study",
                    "criterion": "participation in other study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}