{
    "info": {
        "nct_id": "NCT00709020",
        "official_title": "A Translational Breast Cancer Prevention Trial of Mushroom Powder in Postmenopausal Breast Cancer Survivors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 21 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n  * Prior diagnosis of infiltrating carcinoma of the breast ≥ 5 years prior to study entry\n  * Prior diagnosis of ductal carcinoma in situ\n* No evidence of disease\n* Completed all cancer therapy, with the exception of reconstructive surgery, at least 6 months prior to study entry\n* Meets one of the following criteria:\n\n  * Normal mammogram within 1 year of study entry\n  * Underwent bilateral mastectomy and has been in remission for 5 years, as documented by an oncologist\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* WBC ≥ 3,500/mm³\n* ANC ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Hemoglobin ≥ 9.0 g/dL\n* Postmenopausal, defined as any of the following:\n\n  * Continuous absence of menstruation for 12+ months\n  * Status post bilateral oophorectomy\n  * Status post hysterectomy with follicle-stimulating hormone in menopausal range\n* Creatinine ≤ 1.5 times upper limit of normal (ULN) or less\n* Total bilirubin ≤ 1.5 times ULN\n* AST and ALT < 2 times ULN\n* No allergy to mushrooms\n* No personal history of any invasive cancer, other than breast cancer, or squamous cell or basal cell skin cancer\n* No osteoporosis, defined as a bone-mineral density T-score of < -2.5 on dual-energy x-ray absorptiometry scan\n* No major systemic infections or other major medical illnesses of the cardiovascular, respiratory, or digestive system\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 3 months since prior and no concurrent hormone-modifying medications, including any of the following:\n\n  * Oral contraceptives\n  * Hormone replacement\n  * Selective estrogen receptor modifiers\n  * Other aromatase inhibitors\n  * Gonadotropic-releasing hormone modifiers\n* At least 1 month since prior and no other concurrent mushroom extracts or DHEA as a dietary supplement\n* No concurrent therapy, except continued medications for unrelated illness that are not excluded, and necessary medications for unrelated acute illnesses that may occur during the study (e.g., cold, flu, or infection)\n* No more than 3 concurrent servings per week of the following foods:\n\n  * Flaxseeds and flaxseed meal\n  * High-energy bars or diet bars containing soy or soy protein\n  * Liquid-nutrition drinks containing soy or soy protein (e.g., Odwalla Future Shake or Ensure Plus)\n  * Miso soup\n  * Natto\n  * Packaged mixed dishes with soy or tofu (e.g., lasagna, burritos, or stir-fry)\n  * Cooked soybeans or edamame (i.e., green soybeans)\n  * Roasted soy nuts\n  * Soymilk, regular or low-fat, plain or flavored\n  * Soy cheese, such as cheddar, mozzarella, cram cheese, or parmesan (includes all foods made with soy cheese)\n  * Soy protein powders (e.g., performance or body-builder powders)\n  * Soy yogurt, all types\n  * Soy sauce, tamari, teriyaki sauce, Szechuan sauce, or hoisin sauce\n  * Soy ice cream, tofutti, or other soy desserts\n  * Tempeh, all types\n  * Tofu, all types, including low-fat, flavored, marinated, and smoked\n  * Tofu or soy breakfast sausage, bacon, or other breakfast meat\n  * Tofu or soy cold cuts, hot dogs, or other deli meat substitutes\n  * Veggie soy or tofu burger, ground meat substitute (texturized vegetable protein), or soy or tofu, chicken, or turkey\n* Concurrent supplemental calcium and/or vitamin D and bisphosphonates allowed provided doses remain constant throughout the run-in and treatment portions of the trial"
    },
    "inclusion_lines": [
        {
            "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": "N/A",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior diagnosis of infiltrating carcinoma of the breast ≥ 5 years prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Prior diagnosis of infiltrating carcinoma of the breast",
                    "criterion": "infiltrating carcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 5 years prior to study entry",
                    "criterion": "time since diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior diagnosis of ductal carcinoma in situ",
            "criterions": [
                {
                    "exact_snippets": "Prior diagnosis of ductal carcinoma in situ",
                    "criterion": "ductal carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of disease",
            "criterions": [
                {
                    "exact_snippets": "No evidence of disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Completed all cancer therapy, with the exception of reconstructive surgery, at least 6 months prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Completed all cancer therapy, with the exception of reconstructive surgery, at least 6 months prior to study entry",
                    "criterion": "completion of cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Meets one of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Meets one of the following criteria",
                    "criterion": "eligibility criteria",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "one of the following"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal mammogram within 1 year of study entry",
            "criterions": [
                {
                    "exact_snippets": "Normal mammogram within 1 year of study entry",
                    "criterion": "mammogram",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "normal"
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 1 year of study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Underwent bilateral mastectomy and has been in remission for 5 years, as documented by an oncologist",
            "criterions": [
                {
                    "exact_snippets": "Underwent bilateral mastectomy",
                    "criterion": "bilateral mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has been in remission for 5 years",
                    "criterion": "remission",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "as documented by an oncologist",
                    "criterion": "oncologist documentation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor status not specified",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor status",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC ≥ 3,500/mm³",
            "criterions": [
                {
                    "exact_snippets": "WBC ≥ 3,500/mm³",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ANC ≥ 1,500/mm³",
            "criterions": [
                {
                    "exact_snippets": "ANC ≥ 1,500/mm³",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100,000/mm³",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal, defined as any of the following:",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Continuous absence of menstruation for 12+ months",
            "criterions": [
                {
                    "exact_snippets": "Continuous absence of menstruation for 12+ months",
                    "criterion": "absence of menstruation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Status post bilateral oophorectomy",
            "criterions": [
                {
                    "exact_snippets": "Status post bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Status post hysterectomy with follicle-stimulating hormone in menopausal range",
            "criterions": [
                {
                    "exact_snippets": "Status post hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "follicle-stimulating hormone in menopausal range",
                    "criterion": "follicle-stimulating hormone",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "menopausal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 1.5 times upper limit of normal (ULN) or less",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.5 times upper limit of normal (ULN)",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 times ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT < 2 times ULN",
            "criterions": [
                {
                    "exact_snippets": "AST ... < 2 times ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT < 2 times ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No allergy to mushrooms",
            "criterions": [
                {
                    "exact_snippets": "No allergy to mushrooms",
                    "criterion": "allergy to mushrooms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No personal history of any invasive cancer, other than breast cancer, or squamous cell or basal cell skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No personal history of any invasive cancer, other than breast cancer",
                    "criterion": "personal history of invasive cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No personal history of any invasive cancer, other than ... squamous cell or basal cell skin cancer",
                    "criterion": "personal history of squamous cell or basal cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No osteoporosis, defined as a bone-mineral density T-score of < -2.5 on dual-energy x-ray absorptiometry scan",
            "criterions": [
                {
                    "exact_snippets": "No osteoporosis, defined as a bone-mineral density T-score of < -2.5 on dual-energy x-ray absorptiometry scan",
                    "criterion": "osteoporosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bone-mineral density T-score of < -2.5 on dual-energy x-ray absorptiometry scan",
                    "criterion": "bone-mineral density T-score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": -2.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No major systemic infections or other major medical illnesses of the cardiovascular, respiratory, or digestive system",
            "criterions": [
                {
                    "exact_snippets": "No major systemic infections",
                    "criterion": "systemic infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not major"
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... other major medical illnesses of the cardiovascular ... system",
                    "criterion": "cardiovascular system medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not major"
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... other major medical illnesses of the ... respiratory ... system",
                    "criterion": "respiratory system medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not major"
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... other major medical illnesses of the ... digestive system",
                    "criterion": "digestive system medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not major"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see details"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 3 months since prior and no concurrent hormone-modifying medications, including any of the following:",
            "criterions": [
                {
                    "exact_snippets": "More than 3 months since prior ... hormone-modifying medications",
                    "criterion": "hormone-modifying medications",
                    "requirements": [
                        {
                            "requirement_type": "time since prior use",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Oral contraceptives",
            "criterions": [
                {
                    "exact_snippets": "Oral contraceptives",
                    "criterion": "oral contraceptives",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone replacement",
            "criterions": [
                {
                    "exact_snippets": "Hormone replacement",
                    "criterion": "hormone replacement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Selective estrogen receptor modifiers",
            "criterions": [
                {
                    "exact_snippets": "Selective estrogen receptor modifiers",
                    "criterion": "selective estrogen receptor modifiers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other aromatase inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Other aromatase inhibitors",
                    "criterion": "aromatase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gonadotropic-releasing hormone modifiers",
            "criterions": [
                {
                    "exact_snippets": "Gonadotropic-releasing hormone modifiers",
                    "criterion": "gonadotropic-releasing hormone modifiers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 month since prior and no other concurrent mushroom extracts or DHEA as a dietary supplement",
            "criterions": [
                {
                    "exact_snippets": "At least 1 month since prior ... mushroom extracts",
                    "criterion": "mushroom extracts",
                    "requirements": [
                        {
                            "requirement_type": "time since prior use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        },
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 1 month since prior ... DHEA as a dietary supplement",
                    "criterion": "DHEA as a dietary supplement",
                    "requirements": [
                        {
                            "requirement_type": "time since prior use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        },
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent therapy, except continued medications for unrelated illness that are not excluded, and necessary medications for unrelated acute illnesses that may occur during the study (e.g., cold, flu, or infection)",
            "criterions": [
                {
                    "exact_snippets": "No concurrent therapy",
                    "criterion": "concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "continued medications for unrelated illness that are not excluded",
                    "criterion": "continued medications for unrelated illness",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "necessary medications for unrelated acute illnesses that may occur during the study",
                    "criterion": "necessary medications for unrelated acute illnesses",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No more than 3 concurrent servings per week of the following foods:",
            "criterions": [
                {
                    "exact_snippets": "No more than 3 concurrent servings per week of the following foods",
                    "criterion": "servings of specific foods",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "servings per week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Flaxseeds and flaxseed meal",
            "criterions": [
                {
                    "exact_snippets": "Flaxseeds",
                    "criterion": "flaxseeds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "flaxseed meal",
                    "criterion": "flaxseed meal",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High-energy bars or diet bars containing soy or soy protein",
            "criterions": [
                {
                    "exact_snippets": "High-energy bars or diet bars containing soy or soy protein",
                    "criterion": "consumption of high-energy or diet bars",
                    "requirements": [
                        {
                            "requirement_type": "content",
                            "expected_value": [
                                "soy",
                                "soy protein"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Liquid-nutrition drinks containing soy or soy protein (e.g., Odwalla Future Shake or Ensure Plus)",
            "criterions": [
                {
                    "exact_snippets": "Liquid-nutrition drinks containing soy or soy protein",
                    "criterion": "liquid-nutrition drinks",
                    "requirements": [
                        {
                            "requirement_type": "content",
                            "expected_value": [
                                "soy",
                                "soy protein"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Natto",
            "criterions": [
                {
                    "exact_snippets": "Natto",
                    "criterion": "Natto",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Packaged mixed dishes with soy or tofu (e.g., lasagna, burritos, or stir-fry)",
            "criterions": [
                {
                    "exact_snippets": "Packaged mixed dishes with soy or tofu",
                    "criterion": "packaged mixed dishes",
                    "requirements": [
                        {
                            "requirement_type": "ingredients",
                            "expected_value": [
                                "soy",
                                "tofu"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cooked soybeans or edamame (i.e., green soybeans)",
            "criterions": [
                {
                    "exact_snippets": "Cooked soybeans or edamame (i.e., green soybeans)",
                    "criterion": "dietary intake",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "cooked soybeans",
                                "edamame"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Roasted soy nuts",
            "criterions": [
                {
                    "exact_snippets": "Roasted soy nuts",
                    "criterion": "dietary intake",
                    "requirements": [
                        {
                            "requirement_type": "specific food",
                            "expected_value": "roasted soy nuts"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Soymilk, regular or low-fat, plain or flavored",
            "criterions": [
                {
                    "exact_snippets": "Soymilk, regular or low-fat",
                    "criterion": "soymilk fat content",
                    "requirements": [
                        {
                            "requirement_type": "fat content",
                            "expected_value": [
                                "regular",
                                "low-fat"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Soymilk, ... plain or flavored",
                    "criterion": "soymilk flavor",
                    "requirements": [
                        {
                            "requirement_type": "flavor",
                            "expected_value": [
                                "plain",
                                "flavored"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Soy cheese, such as cheddar, mozzarella, cram cheese, or parmesan (includes all foods made with soy cheese)",
            "criterions": [
                {
                    "exact_snippets": "Soy cheese, such as cheddar, mozzarella, cram cheese, or parmesan (includes all foods made with soy cheese)",
                    "criterion": "soy cheese",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "cheddar",
                                "mozzarella",
                                "cram cheese",
                                "parmesan"
                            ]
                        },
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "all foods made with soy cheese"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Soy protein powders (e.g., performance or body-builder powders)",
            "criterions": [
                {
                    "exact_snippets": "Soy protein powders (e.g., performance or body-builder powders)",
                    "criterion": "soy protein powders",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "performance powders",
                                "body-builder powders"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Soy yogurt, all types",
            "criterions": [
                {
                    "exact_snippets": "Soy yogurt, all types",
                    "criterion": "soy yogurt",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "all types"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Soy sauce, tamari, teriyaki sauce, Szechuan sauce, or hoisin sauce",
            "criterions": [
                {
                    "exact_snippets": "Soy sauce",
                    "criterion": "soy sauce",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tamari",
                    "criterion": "tamari",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "teriyaki sauce",
                    "criterion": "teriyaki sauce",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Szechuan sauce",
                    "criterion": "Szechuan sauce",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hoisin sauce",
                    "criterion": "hoisin sauce",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Soy ice cream, tofutti, or other soy desserts",
            "criterions": [
                {
                    "exact_snippets": "Soy ice cream, tofutti, or other soy desserts",
                    "criterion": "dietary restrictions",
                    "requirements": [
                        {
                            "requirement_type": "allowed foods",
                            "expected_value": [
                                "Soy ice cream",
                                "tofutti",
                                "other soy desserts"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tempeh, all types",
            "criterions": [
                {
                    "exact_snippets": "Tempeh, all types",
                    "criterion": "tempeh consumption",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "all types"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tofu, all types, including low-fat, flavored, marinated, and smoked",
            "criterions": [
                {
                    "exact_snippets": "Tofu, all types, including low-fat, flavored, marinated, and smoked",
                    "criterion": "tofu type",
                    "requirements": [
                        {
                            "requirement_type": "variety",
                            "expected_value": [
                                "low-fat",
                                "flavored",
                                "marinated",
                                "smoked"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tofu or soy breakfast sausage, bacon, or other breakfast meat",
            "criterions": [
                {
                    "exact_snippets": "Tofu or soy breakfast sausage, bacon, or other breakfast meat",
                    "criterion": "dietary intake",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "Tofu",
                                "soy breakfast sausage",
                                "bacon",
                                "other breakfast meat"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tofu or soy cold cuts, hot dogs, or other deli meat substitutes",
            "criterions": [
                {
                    "exact_snippets": "Tofu or soy cold cuts, hot dogs, or other deli meat substitutes",
                    "criterion": "dietary intake",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "Tofu",
                                "soy cold cuts",
                                "hot dogs",
                                "deli meat substitutes"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Veggie soy or tofu burger, ground meat substitute (texturized vegetable protein), or soy or tofu, chicken, or turkey",
            "criterions": [
                {
                    "exact_snippets": "Veggie soy or tofu burger",
                    "criterion": "dietary option",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ground meat substitute (texturized vegetable protein)",
                    "criterion": "dietary option",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "soy or tofu",
                    "criterion": "dietary option",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chicken",
                    "criterion": "dietary option",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "turkey",
                    "criterion": "dietary option",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent supplemental calcium and/or vitamin D and bisphosphonates allowed provided doses remain constant throughout the run-in and treatment portions of the trial",
            "criterions": [
                {
                    "exact_snippets": "Concurrent supplemental calcium ... doses remain constant",
                    "criterion": "supplemental calcium",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dose stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent ... vitamin D ... doses remain constant",
                    "criterion": "vitamin D",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dose stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent ... bisphosphonates ... doses remain constant",
                    "criterion": "bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dose stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* Meets 1 of the following criteria:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Miso soup",
            "criterions": []
        }
    ]
}