{
    "info": {
        "nct_id": "NCT01293591",
        "official_title": "Garlic Intake And Biomarkers Of Cancer Risk",
        "inclusion_criteria": "* Age 40-80 years\nHealthy volunteers allowed\nMust have minimum age of 40 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Younger than 40 years old or older than 80 years old\n* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione)\n* Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases or malabsorption syndromes.\n* Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study\n* Follicle stimulating hormone levels above 35 mIU/mL serum\n* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin\n* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)\n* Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity\n* Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).\n* Use of any tobacco products in past 6 months\n* Use of oral or IV antibiotics during the month preceding the study or during the study\n* Unwillingness to abstain from vitamin, mineral, and herbal supplements for two weeks prior to the study and during the study\n* Known (self-reported) allergy or adverse reaction to garlic\n* Inability to metabolize garlic\n* Unable or unwilling to give informed consent or communicate with study staff\n* Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)\n* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age 40-80 years",
            "criterions": [
                {
                    "exact_snippets": "Age 40-80 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 40,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 40 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 40 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Younger than 40 years old or older than 80 years old",
            "criterions": [
                {
                    "exact_snippets": "Younger than 40 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "older than 80 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 80,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione)",
            "criterions": [
                {
                    "exact_snippets": "Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione)",
                    "criterion": "blood-thinning medications",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": [
                                "Coumadin (warfarin)",
                                "Dicumarol (dicumarol)",
                                "Miradon (anisinidione)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study",
            "criterions": [
                {
                    "exact_snippets": "Have been pregnant during the previous 12 months",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "previous 12 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "are currently pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to become pregnant during the study",
                    "criterion": "pregnancy intention",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Follicle stimulating hormone levels above 35 mIU/mL serum",
            "criterions": [
                {
                    "exact_snippets": "Follicle stimulating hormone levels above 35 mIU/mL serum",
                    "criterion": "follicle stimulating hormone levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 35,
                                "unit": "mIU/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin",
            "criterions": [
                {
                    "exact_snippets": "Type 2 diabetes requiring the use of oral antidiabetic agents or insulin",
                    "criterion": "Type 2 diabetes",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "oral antidiabetic agents",
                                "insulin"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)",
            "criterions": [
                {
                    "exact_snippets": "History of eating disorders",
                    "criterion": "eating disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other dietary patterns which are not consistent with the dietary intervention",
                    "criterion": "dietary patterns",
                    "requirements": [
                        {
                            "requirement_type": "consistency with dietary intervention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "vegetarians",
                    "criterion": "vegetarian diet",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "very low fat diets",
                    "criterion": "very low fat diet",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high protein diets",
                    "criterion": "high protein diet",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity",
            "criterions": [
                {
                    "exact_snippets": "Use of prescription or over-the-counter antiobesity medications or supplements",
                    "criterion": "use of antiobesity medications or supplements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "a history of a surgical intervention for obesity",
                    "criterion": "history of surgical intervention for obesity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).",
            "criterions": [
                {
                    "exact_snippets": "Active cardiovascular disease (such as a heart attack ... within the past three months",
                    "criterion": "active cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart attack ... within the past three months",
                    "criterion": "heart attack",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "procedure within the past three months",
                    "criterion": "cardiovascular procedure",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participation in a cardiac rehabilitation program within the last three months",
                    "criterion": "participation in a cardiac rehabilitation program",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history/treatment for transient ischemic attacks in the past three months",
                    "criterion": "transient ischemic attacks",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "documented history of pulmonary embolus in the past six months",
                    "criterion": "pulmonary embolus",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of any tobacco products in past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Use of any tobacco products in past 6 months",
                    "criterion": "tobacco use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 6 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of oral or IV antibiotics during the month preceding the study or during the study",
            "criterions": [
                {
                    "exact_snippets": "Use of oral or IV antibiotics during the month preceding the study",
                    "criterion": "use of oral or IV antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the month preceding the study"
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of oral or IV antibiotics ... during the study",
                    "criterion": "use of oral or IV antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unwillingness to abstain from vitamin, mineral, and herbal supplements for two weeks prior to the study and during the study",
            "criterions": [
                {
                    "exact_snippets": "Unwillingness to abstain from vitamin, mineral, and herbal supplements",
                    "criterion": "abstinence from supplements",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "two weeks prior to the study",
                    "criterion": "abstinence duration prior to study",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study",
                    "criterion": "abstinence duration during study",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "entire study period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known (self-reported) allergy or adverse reaction to garlic",
            "criterions": [
                {
                    "exact_snippets": "Known (self-reported) allergy or adverse reaction to garlic",
                    "criterion": "allergy or adverse reaction to garlic",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to metabolize garlic",
            "criterions": [
                {
                    "exact_snippets": "Inability to metabolize garlic",
                    "criterion": "garlic metabolism",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable or unwilling to give informed consent or communicate with study staff",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Unable or unwilling to ... communicate with study staff",
                    "criterion": "communication with study staff",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)",
            "criterions": [
                {
                    "exact_snippets": "Self-report of alcohol or substance abuse within the past twelve months",
                    "criterion": "alcohol or substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past twelve months"
                        }
                    ]
                },
                {
                    "exact_snippets": "current acute treatment or rehabilitation program for these problems",
                    "criterion": "acute treatment or rehabilitation program",
                    "requirements": [
                        {
                            "requirement_type": "current participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol",
            "criterions": [
                {
                    "exact_snippets": "Other medical, psychiatric, or behavioral factors",
                    "criterion": "medical, psychiatric, or behavioral factors",
                    "requirements": [
                        {
                            "requirement_type": "interference with study participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Other medical, psychiatric, or behavioral factors",
                    "criterion": "medical, psychiatric, or behavioral factors",
                    "requirements": [
                        {
                            "requirement_type": "interference with ability to follow the intervention protocol",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases or malabsorption syndromes.",
            "criterions": [
                {
                    "exact_snippets": "Presence of kidney disease",
                    "criterion": "kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of gout",
                    "criterion": "gout",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of certain cancers",
                    "criterion": "certain cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of thyroid disease",
                    "criterion": "thyroid disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of gastrointestinal ... diseases",
                    "criterion": "gastrointestinal diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of other metabolic diseases",
                    "criterion": "other metabolic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of malabsorption syndromes",
                    "criterion": "malabsorption syndromes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}