{
    "info": {
        "nct_id": "NCT00330382",
        "official_title": "Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial",
        "inclusion_criteria": "* Histologically and clinically confirmed oral leukoplakia and/or erythroplakia\n* Bidimensionally measurable disease (≥ 100 mm^2 for total area of all lesions) after biopsy\n* No presence of obvious head and neck aerodigestive tract cancer, carcinoma in situ, or previously treated head and neck cancer within the past 2 years\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No history of allergic reaction to soybeans, sorbitol, sucrose, artificial flavorings, aspartame, saccharin, or lidocaine\n* At least 6 months since prior Bowman-Birk inhibitor concentrate\n* At least 6 months since prior participation in another randomized clinical trail\n* At least 3 months since prior systemic steroids or topical oral steroid preparations\n\n  * Topical nasal steroid sprays or cutaneous preparations with minimal systemic absorption for nasal or dermatologic disorders allowed\n* More than 6 months since prior beta carotene capsules\n* At least 2 years since prior retinoid or other beta carotene therapy, including > 25,000 IU of vitamin A for any reason\n\n  * Up to 2 multivitamins per day allowed\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically and clinically confirmed oral leukoplakia and/or erythroplakia",
            "criterions": [
                {
                    "exact_snippets": "Histologically and clinically confirmed oral leukoplakia",
                    "criterion": "oral leukoplakia",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "clinically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically and clinically confirmed ... erythroplakia",
                    "criterion": "erythroplakia",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "clinically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bidimensionally measurable disease (≥ 100 mm^2 for total area of all lesions) after biopsy",
            "criterions": [
                {
                    "exact_snippets": "Bidimensionally measurable disease (≥ 100 mm^2 for total area of all lesions)",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "mm^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No presence of obvious head and neck aerodigestive tract cancer, carcinoma in situ, or previously treated head and neck cancer within the past 2 years",
            "criterions": [
                {
                    "exact_snippets": "No presence of obvious head and neck aerodigestive tract cancer",
                    "criterion": "head and neck aerodigestive tract cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No presence of ... carcinoma in situ",
                    "criterion": "carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No presence of ... previously treated head and neck cancer within the past 2 years",
                    "criterion": "previously treated head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of allergic reaction to soybeans, sorbitol, sucrose, artificial flavorings, aspartame, saccharin, or lidocaine",
            "criterions": [
                {
                    "exact_snippets": "No history of allergic reaction to soybeans",
                    "criterion": "allergic reaction to soybeans",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of allergic reaction to ... sorbitol",
                    "criterion": "allergic reaction to sorbitol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of allergic reaction to ... sucrose",
                    "criterion": "allergic reaction to sucrose",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of allergic reaction to ... artificial flavorings",
                    "criterion": "allergic reaction to artificial flavorings",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of allergic reaction to ... aspartame",
                    "criterion": "allergic reaction to aspartame",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of allergic reaction to ... saccharin",
                    "criterion": "allergic reaction to saccharin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of allergic reaction to ... lidocaine",
                    "criterion": "allergic reaction to lidocaine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 6 months since prior Bowman-Birk inhibitor concentrate",
            "criterions": [
                {
                    "exact_snippets": "At least 6 months since prior Bowman-Birk inhibitor concentrate",
                    "criterion": "time since prior Bowman-Birk inhibitor concentrate",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 months since prior systemic steroids or topical oral steroid preparations",
            "criterions": [
                {
                    "exact_snippets": "At least 3 months since prior systemic steroids",
                    "criterion": "prior systemic steroids",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 months since prior ... topical oral steroid preparations",
                    "criterion": "prior topical oral steroid preparations",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Topical nasal steroid sprays or cutaneous preparations with minimal systemic absorption for nasal or dermatologic disorders allowed",
            "criterions": [
                {
                    "exact_snippets": "Topical nasal steroid sprays ... allowed",
                    "criterion": "topical nasal steroid sprays",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cutaneous preparations with minimal systemic absorption ... allowed",
                    "criterion": "cutaneous preparations with minimal systemic absorption",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 6 months since prior beta carotene capsules",
            "criterions": [
                {
                    "exact_snippets": "More than 6 months since prior beta carotene capsules",
                    "criterion": "beta carotene capsules",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 2 years since prior retinoid or other beta carotene therapy, including > 25,000 IU of vitamin A for any reason",
            "criterions": [
                {
                    "exact_snippets": "At least 2 years since prior retinoid or other beta carotene therapy",
                    "criterion": "time since prior retinoid or beta carotene therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including > 25,000 IU of vitamin A for any reason",
                    "criterion": "prior vitamin A therapy",
                    "requirements": [
                        {
                            "requirement_type": "amount",
                            "expected_value": {
                                "operator": ">",
                                "value": 25000,
                                "unit": "IU"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Up to 2 multivitamins per day allowed",
            "criterions": [
                {
                    "exact_snippets": "Up to 2 multivitamins per day allowed",
                    "criterion": "multivitamin intake",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "multivitamins per day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 6 months since prior participation in another randomized clinical trail",
            "criterions": [
                {
                    "exact_snippets": "At least 6 months since prior participation in another randomized clinical trial",
                    "criterion": "time since prior participation in another randomized clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}