{
    "info": {
        "nct_id": "NCT00475982",
        "official_title": "Effect of Weight Loss on Prostate Cancer Pathology",
        "inclusion_criteria": "* Subject is overweight or obese (BMI > 25 kg/m2)\n* Patient with pathologically confirmed adenocarcinoma of the prostate and has elected to undergo radical prostatectomy\n* Willing to delay radical prostatectomy for 5 to 8-weeks if randomized to the weight loss intervention group.\n* Able to adhere to physical activity intervention (able to walk for 30 minutes without rest)\n* Able to come to the VA for weight loss visits during the 5 to 8-wk study\nHealthy volunteers allowed\nMust be MALE",
        "exclusion_criteria": "* Any one of the following: Gleason grade > 4+4, PSA > 20.\n* History of ever receiving androgen deprivation therapy, antiandrogen therapy, or finasteride\n* Prior prostate radiotherapy (external beam or brachytherapy) or prior cryotherapy\n* Diagnosis of diabetes mellitus and on insulin**\n* Current use of weight loss medications or enrolled in a diet/weight loss program\n* Current use of lycopene supplements*** Significant co-morbidities (i.e. cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) Cardiac pacemaker",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subject is overweight or obese (BMI > 25 kg/m2)",
            "criterions": [
                {
                    "exact_snippets": "Subject is overweight or obese (BMI > 25 kg/m2)",
                    "criterion": "BMI",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "kg/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with pathologically confirmed adenocarcinoma of the prostate and has elected to undergo radical prostatectomy",
            "criterions": [
                {
                    "exact_snippets": "pathologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "elected to undergo radical prostatectomy",
                    "criterion": "radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "elected to undergo"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to delay radical prostatectomy for 5 to 8-weeks if randomized to the weight loss intervention group.",
            "criterions": [
                {
                    "exact_snippets": "Willing to delay radical prostatectomy",
                    "criterion": "willingness to delay radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "5 to 8-weeks",
                    "criterion": "delay duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 8,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to adhere to physical activity intervention (able to walk for 30 minutes without rest)",
            "criterions": [
                {
                    "exact_snippets": "Able to adhere to physical activity intervention (able to walk for 30 minutes without rest)",
                    "criterion": "physical activity adherence",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": "able to walk for 30 minutes without rest"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to come to the VA for weight loss visits during the 5 to 8-wk study",
            "criterions": [
                {
                    "exact_snippets": "Able to come to the VA for weight loss visits",
                    "criterion": "ability to attend visits",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the 5 to 8-wk study",
                    "criterion": "study duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "wk"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 8,
                                        "unit": "wk"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Any one of the following: Gleason grade > 4+4, PSA > 20.",
            "criterions": [
                {
                    "exact_snippets": "Gleason grade > 4+4",
                    "criterion": "Gleason grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA > 20",
                    "criterion": "PSA",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of ever receiving androgen deprivation therapy, antiandrogen therapy, or finasteride",
            "criterions": [
                {
                    "exact_snippets": "History of ever receiving androgen deprivation therapy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ever receiving ... antiandrogen therapy",
                    "criterion": "antiandrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ever receiving ... finasteride",
                    "criterion": "finasteride",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior prostate radiotherapy (external beam or brachytherapy) or prior cryotherapy",
            "criterions": [
                {
                    "exact_snippets": "Prior prostate radiotherapy (external beam or brachytherapy)",
                    "criterion": "prior prostate radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior cryotherapy",
                    "criterion": "prior cryotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of diabetes mellitus and on insulin**",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on insulin",
                    "criterion": "insulin usage",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current use of weight loss medications or enrolled in a diet/weight loss program",
            "criterions": [
                {
                    "exact_snippets": "Current use of weight loss medications",
                    "criterion": "weight loss medications",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "enrolled in a diet/weight loss program",
                    "criterion": "diet/weight loss program",
                    "requirements": [
                        {
                            "requirement_type": "enrollment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current use of lycopene supplements*** Significant co-morbidities (i.e. cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) Cardiac pacemaker",
            "criterions": [
                {
                    "exact_snippets": "Current use of lycopene supplements",
                    "criterion": "lycopene supplements",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant co-morbidities (i.e. cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse)",
                    "criterion": "significant co-morbidities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "cardiac disease",
                                "pulmonary disease",
                                "liver disease",
                                "ongoing alcohol abuse",
                                "ongoing drug abuse"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiac pacemaker",
                    "criterion": "cardiac pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}