欧盟临床详情页-详情信息

{ "code": 200, "msg": "查询成功", "data": { "A.": [ { "eng_attr": "Protocol Information", "chs_attr": "协议信息", "index_num": "A.", "attr_value": null, "display_order": 1 }, { "eng_attr": "Member State Concerned", "chs_attr": "有关成员国", "index_num": "A.1", "attr_value": [ "Spain - AEMPS" ], "display_order": 2 }, { "eng_attr": "EudraCT number", "chs_attr": "EudraCT号", "index_num": "A.2", "attr_value": [ "2012-000622-22" ], "display_order": 3 }, { "eng_attr": "Full title of the trial", "chs_attr": "试验标题", "index_num": "A.3", "attr_value": [ "Aspirin for the enhancement of trophoblastic invasion in women with abnormal uterine artery Doppler at 11-14 weeks of gestation" ], "display_order": 4 }, { "eng_attr": "Full title of the trial (es)", "chs_attr": "试验标题(es)", "index_num": "A.3", "attr_value": [ "Acido acetilsalicílico para la mejora de la invasión trofoblástica en gestantes con doppler patológico de las uterinas a las 11-14 semanas de gestación" ], "display_order": 5 }, { "eng_attr": "Title of the trial for lay people, in easily understood, i.e. non-technical, language", "chs_attr": "通俗试验标题", "index_num": "A.3.1", "attr_value": [ "Use of Aspirin to improve the transport of blood to the fetus in patients with altered Doppler US" ], "display_order": 6 }, { "eng_attr": "Title of the trial for lay people, in easily understood, i.e. non-technical, language (es)", "chs_attr": "通俗试验标题(es)", "index_num": "A.3.1", "attr_value": [ "Utilización del ácido acetilsalicílico para la mejora del transporte de la sangre al feto en pacientes que presentan ecografías Doppler alteradas" ], "display_order": 7 }, { "eng_attr": "Name or abbreviated title of the trial where available", "chs_attr": "试验名称或缩写名称（如果有）", "index_num": "A.3.2", "attr_value": [ "-" ], "display_order": 8 }, { "eng_attr": "Sponsor's protocol code number", "chs_attr": "赞助商协议编号", "index_num": "A.4.1", "attr_value": [ "ASAP" ], "display_order": 9 }, { "eng_attr": "Trial is part of a Paediatric Investigation Plan", "chs_attr": "试验是儿科调查计划的一部分", "index_num": "A.7", "attr_value": [ "No" ], "display_order": 10 }, { "eng_attr": "EMA Decision number of Paediatric Investigation Plan", "chs_attr": "儿科检查计划的欧洲药品管理局决定号", "index_num": "A.8", "attr_value": [ "-" ], "display_order": 11 } ], "B.": [ { "eng_attr": "Sponsor Information", "chs_attr": "赞助商信息", "index_num": "B.", "attr_value": null, "display_order": 12 }, { "eng_attr": "Sponsor:1", "chs_attr": null, "index_num": "B.", "attr_value": null, "display_order": 13 }, { "eng_attr": "Name of Sponsor", "chs_attr": "赞助人名称", "index_num": "B.1.1", "attr_value": [ "Fundació Clínic per a la Recerca Biomèdica" ], "display_order": 14 }, { "eng_attr": "Country", "chs_attr": "国家", "index_num": "B.1.3.4", "attr_value": [ "Spain" ], "display_order": 15 }, { "eng_attr": "Status of the sponsor", "chs_attr": "赞助人身份", "index_num": "B.3.1 and B.3.2", "attr_value": [ "Non-Commercial" ], "display_order": 16 }, { "eng_attr": "Source(s) of Monetary or Material Support for the clinical trial", "chs_attr": "用于临床试验的资金或物质支持来源", "index_num": "B.4", "attr_value": null, "display_order": 17 }, { "eng_attr": "Name of organisation providing support", "chs_attr": "提供支持的组织名称", "index_num": "B.4.1", "attr_value": [ "MSPS Ministerio de Sanidad y Política Social" ], "display_order": 18 }, { "eng_attr": "Country", "chs_attr": "国家", "index_num": "B.4.2", "attr_value": [ "Spain" ], "display_order": 19 }, { "eng_attr": "Contact point designated by the sponsor for further information on the trial", "chs_attr": "赞助商指定的联络点，以获取有关试验的更多信息", "index_num": "B.5", "attr_value": null, "display_order": 20 }, { "eng_attr": "Name of organisation", "chs_attr": "机构名称", "index_num": "B.5.1", "attr_value": [ "Fundació Clinic per a la Recerca Biomèdica" ], "display_order": 21 }, { "eng_attr": "Functional name of contact point", "chs_attr": "联络点功能名称", "index_num": "B.5.2", "attr_value": [ "CTU Clinic-Farmacología clinica" ], "display_order": 22 }, { "eng_attr": "Address", "chs_attr": "地址", "index_num": "B.5.3", "attr_value": [ "-" ], "display_order": 23 }, { "eng_attr": "Street Address", "chs_attr": "街道地址", "index_num": "B.5.3.1", "attr_value": [ "Villarroel 170" ], "display_order": 24 }, { "eng_attr": "Town/ city", "chs_attr": "城镇/城市", "index_num": "B.5.3.2", "attr_value": [ "Barcelona" ], "display_order": 25 }, { "eng_attr": "Post code", "chs_attr": "邮政编码", "index_num": "B.5.3.3", "attr_value": [ "08036" ], "display_order": 26 }, { "eng_attr": "Country", "chs_attr": "国家", "index_num": "B.5.3.4", "attr_value": [ "Spain" ], "display_order": 27 }, { "eng_attr": "Telephone number", "chs_attr": "电话号码", "index_num": "B.5.4", "attr_value": [ "+349322754003343" ], "display_order": 28 }, { "eng_attr": "Fax number", "chs_attr": "传真号码", "index_num": "B.5.5", "attr_value": [ "+34932279877" ], "display_order": 29 }, { "eng_attr": "E-mail", "chs_attr": "电子邮件", "index_num": "B.5.6", "attr_value": [ "svarea@clinic.ub.es" ], "display_order": 30 } ], "D.": [ { "eng_attr": "IMP Identification", "chs_attr": "侦查药品（IMP）识别", "index_num": "D.", "attr_value": null, "display_order": 31 }, { "eng_attr": "IMP:1", "chs_attr": null, "index_num": "D.", "attr_value": null, "display_order": 32 }, { "eng_attr": "IMP Role", "chs_attr": "侦查药品角色", "index_num": "D.1.2 and D.1.3", "attr_value": [ "Test" ], "display_order": 33 }, { "eng_attr": "Status of the IMP to be used in the clinical trial", "chs_attr": "用于临床试验的侦查药品状态", "index_num": "D.2", "attr_value": [ "-" ], "display_order": 34 }, { "eng_attr": "IMP to be used in the trial has a marketing authorisation", "chs_attr": "试验中使用的侦查药品具有行销授权", "index_num": "D.2.1", "attr_value": [ "Yes" ], "display_order": 35 }, { "eng_attr": "Trade name", "chs_attr": "商品名", "index_num": "D.2.1.1.1", "attr_value": [ "Tromatyl 150 mg prolonged-release hard capsules" ], "display_order": 36 }, { "eng_attr": "Name of the Marketing Authorisation holder", "chs_attr": "营销授权持有人姓名", "index_num": "D.2.1.1.2", "attr_value": [ "Rottapharm SL" ], "display_order": 37 }, { "eng_attr": "Country which granted the Marketing Authorisation", "chs_attr": "授予营销许可国家/地区", "index_num": "D.2.1.2", "attr_value": [ "Spain" ], "display_order": 38 }, { "eng_attr": "The IMP has been designated in this indication as an orphan drug in the Community", "chs_attr": "本适应症中被指定为社区孤儿药的侦查药品", "index_num": "D.2.5", "attr_value": [ "No" ], "display_order": 39 }, { "eng_attr": "Orphan drug designation number", "chs_attr": "孤儿药编号", "index_num": "D.2.5.1", "attr_value": [ "-" ], "display_order": 40 }, { "eng_attr": "Description of the IMP", "chs_attr": "侦查药品描述", "index_num": "D.3", "attr_value": null, "display_order": 41 }, { "eng_attr": "Product name", "chs_attr": "产品名称", "index_num": "D.3.1", "attr_value": [ "Tromatyl 150 mg prolonged-release hard capsules" ], "display_order": 42 }, { "eng_attr": "Product code", "chs_attr": "产品代码", "index_num": "D.3.2", "attr_value": [ "-" ], "display_order": 43 }, { "eng_attr": "Pharmaceutical form", "chs_attr": "剂型", "index_num": "D.3.4", "attr_value": [ "Capsule, hard" ], "display_order": 44 }, { "eng_attr": "Specific paediatric formulation", "chs_attr": "特殊儿科配方", "index_num": "D.3.4.1", "attr_value": [ "No" ], "display_order": 45 }, { "eng_attr": "Routes of administration for this IMP", "chs_attr": "侦查药品管理途径", "index_num": "D.3.7", "attr_value": [ "Oral use" ], "display_order": 46 }, { "eng_attr": "IMP Identification Details (Active Substances)", "chs_attr": "侦查药品标识详细信息（活性物质）", "index_num": "D.3.8 to D.3.10", "attr_value": null, "display_order": 47 }, { "eng_attr": "INN - Proposed INN", "chs_attr": "INN-提议的INN", "index_num": "D.3.8", "attr_value": [ "acetylsalicylic acid" ], "display_order": 48 }, { "eng_attr": "CAS number", "chs_attr": "CAS号", "index_num": "D.3.9.1", "attr_value": [ "50-78-2" ], "display_order": 49 }, { "eng_attr": "Other descriptive name", "chs_attr": "其他描述性名称", "index_num": "D.3.9.3", "attr_value": [ "ACETYLSALICYLIC ACID" ], "display_order": 50 }, { "eng_attr": "EV Substance Code", "chs_attr": "EV物质代码", "index_num": "D.3.9.4", "attr_value": [ "SUB12730MIG" ], "display_order": 51 }, { "eng_attr": "Strength", "chs_attr": "强度", "index_num": "D.3.10", "attr_value": null, "display_order": 52 }, { "eng_attr": "Concentration unit", "chs_attr": "浓度单位", "index_num": "D.3.10.1", "attr_value": [ "mg milligram(s)" ], "display_order": 53 }, { "eng_attr": "Concentration type", "chs_attr": "浓度类型", "index_num": "D.3.10.2", "attr_value": [ "equal" ], "display_order": 54 }, { "eng_attr": "Concentration number", "chs_attr": "浓度值", "index_num": "D.3.10.3", "attr_value": [ "150" ], "display_order": 55 }, { "eng_attr": "The IMP contains an", "chs_attr": "IMP包含：", "index_num": "D.3.11", "attr_value": null, "display_order": 56 }, { "eng_attr": "Active substance of chemical origin", "chs_attr": "化学来源的活性物质", "index_num": "D.3.11.1", "attr_value": [ "Yes" ], "display_order": 57 }, { "eng_attr": "Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)", "chs_attr": "生物活性物质/生物技术来源（ATIMP除外）", "index_num": "D.3.11.2", "attr_value": [ "No" ], "display_order": 58 }, { "eng_attr": "Advanced Therapy IMP (ATIMP)", "chs_attr": "先进疗法的侦查药品（ATIMP）", "index_num": "D.3.11.3", "attr_value": [ "No" ], "display_order": 59 }, { "eng_attr": "Somatic cell therapy medicinal product", "chs_attr": "体细胞治疗药物", "index_num": "D.3.11.3.1", "attr_value": [ "No" ], "display_order": 60 }, { "eng_attr": "Gene therapy medical product", "chs_attr": "基因治疗医疗产品", "index_num": "D.3.11.3.2", "attr_value": [ "No" ], "display_order": 61 }, { "eng_attr": "Tissue Engineered Product", "chs_attr": "组织工程产品", "index_num": "D.3.11.3.3", "attr_value": [ "No" ], "display_order": 62 }, { "eng_attr": "Combination ATIMP (i.e. one involving a medical device)", "chs_attr": "组合ATIMP（即涉及医疗设备的一种）", "index_num": "D.3.11.3.4", "attr_value": [ "No" ], "display_order": 63 }, { "eng_attr": "Committee on Advanced therapies (CAT) has issued a classification for this product", "chs_attr": "先进疗法委员会（CAT）已为此产品发布了分类", "index_num": "D.3.11.3.5", "attr_value": [ "No" ], "display_order": 64 }, { "eng_attr": "Combination product that includes a device, but does not involve an Advanced Therapy", "chs_attr": "包括设备但不涉及高级疗法的组合产品", "index_num": "D.3.11.4", "attr_value": [ "No" ], "display_order": 65 }, { "eng_attr": "Radiopharmaceutical medicinal product", "chs_attr": "放射性药物产品", "index_num": "D.3.11.5", "attr_value": [ "No" ], "display_order": 66 }, { "eng_attr": "Immunological medicinal product (such as vaccine, allergen, immune serum)", "chs_attr": "免疫药品（如疫苗，过敏原，免疫血清）", "index_num": "D.3.11.6", "attr_value": [ "No" ], "display_order": 67 }, { "eng_attr": "Plasma derived medicinal product", "chs_attr": "血浆衍生药物", "index_num": "D.3.11.7", "attr_value": [ "No" ], "display_order": 68 }, { "eng_attr": "Extractive medicinal product", "chs_attr": "提取药用产品", "index_num": "D.3.11.8", "attr_value": [ "No" ], "display_order": 69 }, { "eng_attr": "Recombinant medicinal product", "chs_attr": "重组药物", "index_num": "D.3.11.9", "attr_value": [ "No" ], "display_order": 70 }, { "eng_attr": "Medicinal product containing genetically modified organisms", "chs_attr": "含有转基因生物的药品", "index_num": "D.3.11.10", "attr_value": [ "No" ], "display_order": 71 }, { "eng_attr": "Herbal medicinal product", "chs_attr": "草药产品", "index_num": "D.3.11.11", "attr_value": [ "No" ], "display_order": 72 }, { "eng_attr": "Homeopathic medicinal product", "chs_attr": "顺势疗法的药物", "index_num": "D.3.11.12", "attr_value": [ "No" ], "display_order": 73 }, { "eng_attr": "Another type of medicinal product", "chs_attr": "另一类药物", "index_num": "D.3.11.13", "attr_value": [ "No" ], "display_order": 74 }, { "eng_attr": "Information on Placebo", "chs_attr": "有关安慰剂的信息", "index_num": "D.8", "attr_value": null, "display_order": 75 }, { "eng_attr": "Placebo:1", "chs_attr": null, "index_num": "D.8", "attr_value": null, "display_order": 76 }, { "eng_attr": "Is a Placebo used in this Trial? Yes", "chs_attr": "在这个试验中使用安慰剂吗？是的", "index_num": "D.8.1", "attr_value": [ "-" ], "display_order": 77 }, { "eng_attr": "Pharmaceutical form of the placebo", "chs_attr": "安慰剂的药物形式", "index_num": "D.8.3", "attr_value": [ "Capsule, hard" ], "display_order": 78 }, { "eng_attr": "Route of administration of the placebo", "chs_attr": "安慰剂的给药途径", "index_num": "D.8.4", "attr_value": [ "Oral use" ], "display_order": 79 } ], "F.": [ { "eng_attr": "Population of Trial Subjects", "chs_attr": "试验对象的人口", "index_num": "F.", "attr_value": null, "display_order": 169 }, { "eng_attr": "Age Range", "chs_attr": "年龄段", "index_num": "F.1", "attr_value": null, "display_order": 170 }, { "eng_attr": "Trial has subjects under 18", "chs_attr": "试验的对象未满18岁", "index_num": "F.1.1", "attr_value": [ "No" ], "display_order": 171 }, { "eng_attr": "In Utero", "chs_attr": "尚未出生时(的)", "index_num": "F.1.1.1", "attr_value": [ "No" ], "display_order": 172 }, { "eng_attr": "Preterm newborn infants (up to gestational age < 37 weeks)", "chs_attr": "早产儿（不超过胎龄<37周）", "index_num": "F.1.1.2", "attr_value": [ "No" ], "display_order": 173 }, { "eng_attr": "Newborns (0-27 days)", "chs_attr": "新生儿（0-27天）", "index_num": "F.1.1.3", "attr_value": [ "No" ], "display_order": 174 }, { "eng_attr": "Infants and toddlers (28 days-23 months)", "chs_attr": "婴幼儿（28天至23个月）", "index_num": "F.1.1.4", "attr_value": [ "No" ], "display_order": 175 }, { "eng_attr": "Children (2-11years)", "chs_attr": "儿童（2-11岁）", "index_num": "F.1.1.5", "attr_value": [ "No" ], "display_order": 176 }, { "eng_attr": "Adolescents (12-17 years)", "chs_attr": "青少年（12-17岁）", "index_num": "F.1.1.6", "attr_value": [ "No" ], "display_order": 177 }, { "eng_attr": "Adults (18-64 years)", "chs_attr": "成人（18-64岁）", "index_num": "F.1.2", "attr_value": [ "Yes" ], "display_order": 178 }, { "eng_attr": "Number of subjects for this age range", "chs_attr": "此年龄段的受试者人数", "index_num": "F.1.2.1", "attr_value": [ "270" ], "display_order": 179 }, { "eng_attr": "Elderly (>=65 years)", "chs_attr": "老年人（>=65岁）", "index_num": "F.1.3", "attr_value": [ "No" ], "display_order": 180 }, { "eng_attr": "Gender", "chs_attr": "性别", "index_num": "F.2", "attr_value": null, "display_order": 181 }, { "eng_attr": "Female", "chs_attr": "女", "index_num": "F.2.1", "attr_value": [ "Yes" ], "display_order": 182 }, { "eng_attr": "Male", "chs_attr": "男", "index_num": "F.2.2", "attr_value": [ "No" ], "display_order": 183 }, { "eng_attr": "Group of trial subjects", "chs_attr": "试验对象组", "index_num": "F.3", "attr_value": null, "display_order": 184 }, { "eng_attr": "Healthy volunteers", "chs_attr": "健康志愿者", "index_num": "F.3.1", "attr_value": [ "No" ], "display_order": 185 }, { "eng_attr": "Patients", "chs_attr": "患者", "index_num": "F.3.2", "attr_value": [ "Yes" ], "display_order": 186 }, { "eng_attr": "Specific vulnerable populations", "chs_attr": "特定弱势人群", "index_num": "F.3.3", "attr_value": [ "Yes" ], "display_order": 187 }, { "eng_attr": "Women of childbearing potential not using contraception", "chs_attr": "有生育能力的妇女不使用避孕措施", "index_num": "F.3.3.1", "attr_value": [ "No" ], "display_order": 188 }, { "eng_attr": "Women of child-bearing potential using contraception", "chs_attr": "通过避孕有生育能力的妇女", "index_num": "F.3.3.2", "attr_value": [ "No" ], "display_order": 189 }, { "eng_attr": "Pregnant women", "chs_attr": "孕妇", "index_num": "F.3.3.3", "attr_value": [ "Yes" ], "display_order": 190 }, { "eng_attr": "Nursing women", "chs_attr": "哺乳妇女", "index_num": "F.3.3.4", "attr_value": [ "No" ], "display_order": 191 }, { "eng_attr": "Emergency situation", "chs_attr": "危急情况", "index_num": "F.3.3.5", "attr_value": [ "No" ], "display_order": 192 }, { "eng_attr": "Subjects incapable of giving consent personally", "chs_attr": "不能亲自同意的受试者", "index_num": "F.3.3.6", "attr_value": [ "No" ], "display_order": 193 }, { "eng_attr": "Others", "chs_attr": "其他", "index_num": "F.3.3.7", "attr_value": [ "No" ], "display_order": 194 }, { "eng_attr": "Planned number of subjects to be included", "chs_attr": "拟纳入的受试者人数", "index_num": "F.4", "attr_value": null, "display_order": 195 }, { "eng_attr": "In the member state", "chs_attr": "在成员国", "index_num": "F.4.1", "attr_value": [ "270" ], "display_order": 196 }, { "eng_attr": "For a multinational trial", "chs_attr": "进行多国试验", "index_num": "F.4.2", "attr_value": [ "-" ], "display_order": 197 }, { "eng_attr": "Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)", "chs_attr": "在受试者结束参与试验后的治疗或护理计划（如果与该疾病的预期正常治疗不同）", "index_num": "F.5", "attr_value": [ "-" ], "display_order": 198 }, { "eng_attr": "Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition) (es)", "chs_attr": "在受试者结束参与试验后的治疗或护理计划（如果与该疾病的预期正常治疗不同）(es)", "index_num": "F.5", "attr_value": [ "-" ], "display_order": 199 } ], "H.4": [], "G.": [ { "eng_attr": "Investigator Networks to be involved in the Trial", "chs_attr": "参与试验的调查员网络", "index_num": "G.", "attr_value": null, "display_order": 200 } ], "P.": [ { "eng_attr": "End of Trial", "chs_attr": "试验结束", "index_num": "P.", "attr_value": null, "display_order": 207 }, { "eng_attr": "End of Trial Status", "chs_attr": "试验结束状态", "index_num": "P.", "attr_value": [ "Completed" ], "display_order": 208 } ], "N.": [ { "eng_attr": "Review by the Competent Authority or Ethics Committee in the country concerned", "chs_attr": "由相关国家的主管当局或伦理委员会审查", "index_num": "N.", "attr_value": null, "display_order": 201 }, { "eng_attr": "Competent Authority Decision", "chs_attr": "主管当局决定", "index_num": "N.", "attr_value": [ "Authorised" ], "display_order": 202 }, { "eng_attr": "Date of Competent Authority Decision", "chs_attr": "主管当局决定日期", "index_num": "N.", "attr_value": [ "2012-07-20" ], "display_order": 203 }, { "eng_attr": "Ethics Committee Opinion of the trial application", "chs_attr": "伦理委员会关于试验申请的意见", "index_num": "N.", "attr_value": [ "Favourable" ], "display_order": 204 }, { "eng_attr": "Ethics Committee Opinion:Reason(s) for unfavourable opinion", "chs_attr": "伦理委员会对于不利的意见原因", "index_num": "N.", "attr_value": [ "-" ], "display_order": 205 }, { "eng_attr": "Date of Ethics Committee Opinion", "chs_attr": "伦理委员会意见日期", "index_num": "N.", "attr_value": [ "2012-05-11" ], "display_order": 206 } ], "E.": [ { "eng_attr": "General Information on the Trial", "chs_attr": "关于试验的一般资料", "index_num": "E.", "attr_value": null, "display_order": 80 }, { "eng_attr": "Medical condition or disease under investigation", "chs_attr": "调查中的医疗状况或疾病", "index_num": "E.1", "attr_value": null, "display_order": 81 }, { "eng_attr": "Medical condition(s) being investigated", "chs_attr": "正在调查的医疗状况", "index_num": "E.1.1", "attr_value": [ "Placental insufficiency" ], "display_order": 82 }, { "eng_attr": "Medical condition(s) being investigated (es)", "chs_attr": "正在调查的医疗状况 (es)", "index_num": "E.1.1", "attr_value": [ "Insuficiencia placentaria" ], "display_order": 83 }, { "eng_attr": "Medical condition in easily understood language", "chs_attr": "语言简单易懂的医疗状况", "index_num": "E.1.1.1", "attr_value": [ "Placental Insufficiency" ], "display_order": 84 }, { "eng_attr": "Medical condition in easily understood language (es)", "chs_attr": "语言简单易懂的医疗状况(es)", "index_num": "E.1.1.1", "attr_value": [ "insuficiencia placentaria" ], "display_order": 85 }, { "eng_attr": "Therapeutic area", "chs_attr": "药物治疗领域", "index_num": "E.1.1.2", "attr_value": [ "Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]" ], "display_order": 86 }, { "eng_attr": "MedDRA Classification", "chs_attr": "MedDRA分类", "index_num": "E.1.2", "attr_value": null, "display_order": 87 }, { "eng_attr": "Medical condition or disease under investigation", "chs_attr": "调查中的医疗状况或疾病", "index_num": "E.1.2", "attr_value": null, "display_order": 88 }, { "eng_attr": "Version", "chs_attr": "版本", "index_num": "E.1.2", "attr_value": [ "14.1" ], "display_order": 89 }, { "eng_attr": "Level", "chs_attr": "等级", "index_num": "E.1.2", "attr_value": [ "PT" ], "display_order": 90 }, { "eng_attr": "Classification code", "chs_attr": "分类代码", "index_num": "E.1.2", "attr_value": [ "10035138" ], "display_order": 91 }, { "eng_attr": "Term", "chs_attr": "术语", "index_num": "E.1.2", "attr_value": [ "Placental insufficiency" ], "display_order": 92 }, { "eng_attr": "System Organ Class", "chs_attr": "系统器官分类", "index_num": "E.1.2", "attr_value": [ "10036585 - Pregnancy, puerperium and perinatal conditions" ], "display_order": 93 }, { "eng_attr": "Condition being studied is a rare disease", "chs_attr": "所研究的疾病是一种罕见疾病", "index_num": "E.1.3", "attr_value": [ "No" ], "display_order": 94 }, { "eng_attr": "Objective of the trial", "chs_attr": "试验目的", "index_num": "E.2", "attr_value": null, "display_order": 95 }, { "eng_attr": "Main objective of the trial", "chs_attr": "试验主要目的", "index_num": "E.2.1", "attr_value": [ "To establish wether a prophylactic intervention from first trimestre with low-dose of aspirine improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester." ], "display_order": 96 }, { "eng_attr": "Main objective of the trial (es)", "chs_attr": "试验主要目的(es)", "index_num": "E.2.1", "attr_value": [ "Demostrar que el tratamiento con ácido acetilsalicilico a bajas dosis en gestantes de riesgo por doppler patológico de las arterias uterinas en el primer trimestre resulta en una reducción de la resistencia de la circulación placentaria en tercer trimestre" ], "display_order": 97 }, { "eng_attr": "Secondary objectives of the trial", "chs_attr": "试验次要目的", "index_num": "E.2.2", "attr_value": [ "-To establish wether a prophylactic intervention with low-dose of aspirin results in a lower incidence or preeclampsia in pregnant women defined as high-risk by abnormal uterine artery Doppler at first trimester. ", "-To establish wether a prophylactic intervention with low-dose of aspirin results in a lower incidence of intrauterine growth retardation in pregnant women defined as high-risk by abnormal uterine artery Doppler at first trimester. ", "-To establish wether a prophylactic intervention with low-dose of aspirin results in a lower incidence of births below 34 weeks in pregnant women defined as high-risk by abnormal uterine artery Doppler at first trimester." ], "display_order": 98 }, { "eng_attr": "Secondary objectives of the trial (es)", "chs_attr": "试验次要目的(es)", "index_num": "E.2.2", "attr_value": [ "-Demostrar que el tratamiento con acido acetilsalicílico a bajas dosis en gestantes de riesgo por doppler patológico de las arterias uterinas en el primer trimestre resulta en una menor incidencia de preclampsia. ", "-Demostrar que el tratamiento con acido acetilsalicílico a bajas dosis en gestantes de riesgo por doppler patológico de las arterias uterinas en el primer trimestre resulta en una menor incidencia de retraso de crecimiento intrauterino. ", "-Demostrar que el tratamiento con acido acetilsalicílico a bajas dosis en gestantes de riesgo por doppler patológico de las arterias uterinas en el primer trimestre resulta en una menor incidencia de partos por debajo de las 34 semanas" ], "display_order": 99 }, { "eng_attr": "Trial contains a sub-study", "chs_attr": "试验包含子研究", "index_num": "E.2.3", "attr_value": [ "No" ], "display_order": 100 }, { "eng_attr": "Principal inclusion criteria", "chs_attr": "主要纳入标准", "index_num": "E.3", "attr_value": [ "-Patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (Crown-to rump length: 45-48 mm) ", " -Single gestation ", " -Mean pulsatility index of the uterine arteries above the 95th percentile for our population" ], "display_order": 101 }, { "eng_attr": "Principal inclusion criteria (es)", "chs_attr": "主要纳入标准 (es)", "index_num": "E.3", "attr_value": [ "-Pacientes mayores de 18 años que acudan para ecografía de rutina de primer trimestre de la gestación entre las 11 y las 14 semanas de gestación (longitud cráneo caudal 45-48 mm) ", "-Gestaciones únicas ", "-Índice de pulsatilidad medio de las arterias uterinas por encima del percentil 95 para nuestra población" ], "display_order": 102 }, { "eng_attr": "Principal exclusion criteria", "chs_attr": "主要排除标准", "index_num": "E.4", "attr_value": [ "-Pre-existing hypertension, renal or cardiovascular disease ", "- previous history of preeclampsia ", "-Pregestational diabetes ", "-Systemic Lupus Erythematosus ", "-Gastric ulcer ", "-Acetylsalicylic acid or lactose Hypersensitivity ", "-Bleeding disorders ", "Fetal malformations (including chromosomal abnormalities) ", "-Administration of low molecular weight heparin ", "- concomitant treatment with aspirine" ], "display_order": 103 }, { "eng_attr": "Principal exclusion criteria (es)", "chs_attr": "主要排除标准(es)", "index_num": "E.4", "attr_value": [ "- Enfermedad preexistente hipertensiva, renal o cardiovascular ", "-Antecedentes de preeclampsia ", "-Diabetes pregestacional ", "-Lupus eritemasoso sistémico ", "-Úlcera gástrica ", "-Hipersensibilidad al ácido acetilsalicílico o la lactosa ", "-Enfermedades hemorrágicas ", "-Malformaciones fetales (incluidas cromosomopatías) ", "-Administración de heparina de bajo peso molecular ", "- tratamiento concomitante con aspirina" ], "display_order": 104 }, { "eng_attr": "End points", "chs_attr": "终点", "index_num": "E.5", "attr_value": null, "display_order": 105 }, { "eng_attr": "Primary end point(s)", "chs_attr": "主要终点", "index_num": "E.5.1", "attr_value": [ "-Uterine artery mean pulsatility index at 28 weeks." ], "display_order": 106 }, { "eng_attr": "Primary end point(s) (es)", "chs_attr": "主要终点 (es)", "index_num": "E.5.1", "attr_value": [ "-Índice de pulsatilidad medio de las arterias uterinas a las 28 semanas" ], "display_order": 107 }, { "eng_attr": "Timepoint(s) of evaluation of this end point", "chs_attr": "评估该终点的时间点", "index_num": "E.5.1.1", "attr_value": [ "Delivery" ], "display_order": 108 }, { "eng_attr": "Timepoint(s) of evaluation of this end point (es)", "chs_attr": "评估该终点的时间点(es)", "index_num": "E.5.1.1", "attr_value": [ "Parto" ], "display_order": 109 }, { "eng_attr": "Secondary end point(s)", "chs_attr": "次要终点", "index_num": "E.5.2", "attr_value": [ "-Uterine artery pulsatility index at 28 weeks. ", "-Pre-eclampsia: diastolic blood pressure (DBP)> = 90 mmHg) or systolic (SBP)> = 140 mmHg on two separated determinations (> 4h) with proteinuria> 300 mg/24 h ", "-Gestational age at debut of preeclampsia ", "-Severe preeclampsia: preeclampsia criteria + DBP> = 110 mmHg, proteinuria> 5g/24h, oligouria (<400 ml/24h), neurological symptoms (brain or visual), acute pulmonary edema (gasometric and radiological criteria), persistent epigastric pain, abnormal liver function (AST or ALT> 70 IU), analytical signs of hemolysis (LDH> 700 U / L) and / or thrombocytopenia (<100.000/ml). ", "-Gestational age at delivery (preterm birth: before 34 weeks gestation) ", "-Intrauterine Growth Retardation: birth weight below the 10th percentile of our population + pulsatility index in umbilical artery in the third trimester (on two separate occasions >48h) above the 95th percentile. ", "-Emergent cesarean section due to fetal wellbeing loss ", "-Birth weight ", "-Neonatal acidosis (arterial pH <7.10 + EB> 12 mEq / L) ", "-Perinatal mortality (> 22 weeks gestation, <28 days postpartum) ", "-Days in the Neonatal Intensive Care Unit ", "-Significant neonatal morbidity (convulsions, intraventricular hemorrhage> grade III, periventricular leukomalacia, hypoxic-ischemic encephalopathy, abnormal electroencephalogram, necrotizing enterocolitis, acute renal failure (serum creatinine> 1.5 mg / dl) or heart failure (requiring inotropic agents)." ], "display_order": 110 }, { "eng_attr": "Secondary end point(s) (es)", "chs_attr": "次要终点(es)", "index_num": "E.5.2", "attr_value": [ "-Índice de pulsatilidad medio de las arterias uterinas a las 28 semanas ", "-Preeclampsia: tensión arterial diastólica (TAD) >=90 mmHg) y o sistólica (TAS) > = 140 mmHg en dos determinaciones separadas > 4h + proteinuria > 300 mg/24h. ", "-Edad gestacional debut de la preeclampsia ", "-Preeclampsia grave: criterios de preeclampsia + TAD > = 110 mmHg , proteinuria > 5g/24h, oligouria (<400 ml/24h), clínica neurológica (cerebrales o visuales), edema agudo de pulmón (criterio radiológico y gasométrico), dolor epigástrico persistente, alteración de la función hepática (AST o ALT > 70 UI), signos analíticos de hemólisis (LDH>700 U/L) y/o trombocitopenia (<100.000/ml). ", "-Edad gestacional al parto (parto prematuro: antes de las 34 semanas de gestación). ", "-Retraso de crecimiento intrauterino: peso neonatal inferior al percentil 10 de nuestra población + índice de pulsatilidad en la arteria umbilical durante el tercer trimestre (en dos ocasiones separadas > 48h) superior al percentil 95. ", "-Cesarea urgente por pérdida de bienestar fetal. ", "-Peso neonatal ", "-Acidosis neonatal (pH arterial <7.10 + EB > 12 mEq/L) ", "-Mortalidad perinatal (>22 semanas de gestación-<28 días posparto) ", "-Días estancia en la Unidad de Cuidados Intensivos Neonatales ", "-Morbilidad neonatal significativa (convulsiones, hemorragia intraventricular > grado III, leucomalacia periventricular, encefalopatía hipóxico-isquémica, electroencefalograma anormal, enterocolitis necrotizante, fallo renal agudo (creatinina sérica >1,5 mg/dl) o fallo cardiaco (requiriendo agentes inotrópicos)" ], "display_order": 111 }, { "eng_attr": "Timepoint(s) of evaluation of this end point", "chs_attr": "评估该终点的时间点", "index_num": "E.5.2.1", "attr_value": [ "Delivery" ], "display_order": 112 }, { "eng_attr": "Timepoint(s) of evaluation of this end point (es)", "chs_attr": "评估该终点的时间点(es)", "index_num": "E.5.2.1", "attr_value": [ "Parto" ], "display_order": 113 }, { "eng_attr": "Scope of the trial", "chs_attr": "试验范围", "index_num": "E.6 and E.7", "attr_value": null, "display_order": 114 }, { "eng_attr": "Scope of the Trial", "chs_attr": "试验范围", "index_num": "E.6", "attr_value": null, "display_order": 115 }, { "eng_attr": "Diagnosis", "chs_attr": "诊断", "index_num": "E.6.1", "attr_value": [ "No" ], "display_order": 116 }, { "eng_attr": "Prophylaxis", "chs_attr": "预防", "index_num": "E.6.2", "attr_value": [ "Yes" ], "display_order": 117 }, { "eng_attr": "Therapy", "chs_attr": "治疗", "index_num": "E.6.3", "attr_value": [ "No" ], "display_order": 118 }, { "eng_attr": "Safety", "chs_attr": "安全", "index_num": "E.6.4", "attr_value": [ "Yes" ], "display_order": 119 }, { "eng_attr": "Efficacy", "chs_attr": "功效", "index_num": "E.6.5", "attr_value": [ "Yes" ], "display_order": 120 }, { "eng_attr": "Pharmacokinetic", "chs_attr": "药代动力学", "index_num": "E.6.6", "attr_value": [ "No" ], "display_order": 121 }, { "eng_attr": "Pharmacodynamic", "chs_attr": "药效学", "index_num": "E.6.7", "attr_value": [ "No" ], "display_order": 122 }, { "eng_attr": "Bioequivalence", "chs_attr": "生物等效性", "index_num": "E.6.8", "attr_value": [ "No" ], "display_order": 123 }, { "eng_attr": "Dose response", "chs_attr": "剂量反应", "index_num": "E.6.9", "attr_value": [ "No" ], "display_order": 124 }, { "eng_attr": "Pharmacogenetic", "chs_attr": "遗传药理学", "index_num": "E.6.10", "attr_value": [ "No" ], "display_order": 125 }, { "eng_attr": "Pharmacogenomic", "chs_attr": "药物基因组学", "index_num": "E.6.11", "attr_value": [ "No" ], "display_order": 126 }, { "eng_attr": "Pharmacoeconomic", "chs_attr": "药物经济学", "index_num": "E.6.12", "attr_value": [ "No" ], "display_order": 127 }, { "eng_attr": "Others", "chs_attr": "其他", "index_num": "E.6.13", "attr_value": [ "No" ], "display_order": 128 }, { "eng_attr": "Trial type and phase", "chs_attr": "试验类型和阶段", "index_num": "E.7", "attr_value": null, "display_order": 129 }, { "eng_attr": "Human pharmacology (Phase I)", "chs_attr": "人类药理学（第一阶段）", "index_num": "E.7.1", "attr_value": [ "No" ], "display_order": 130 }, { "eng_attr": "First administration to humans", "chs_attr": "首次给人用药", "index_num": "E.7.1.1", "attr_value": [ "No" ], "display_order": 131 }, { "eng_attr": "Bioequivalence study", "chs_attr": "生物等效性研究", "index_num": "E.7.1.2", "attr_value": [ "No" ], "display_order": 132 }, { "eng_attr": "Other", "chs_attr": "其他", "index_num": "E.7.1.3", "attr_value": [ "No" ], "display_order": 133 }, { "eng_attr": "Other trial type description", "chs_attr": "其他试验类型说明", "index_num": "E.7.1.3.1", "attr_value": [ "-" ], "display_order": 134 }, { "eng_attr": "Therapeutic exploratory (Phase II)", "chs_attr": "治疗探索性（第二阶段）", "index_num": "E.7.2", "attr_value": [ "Yes" ], "display_order": 135 }, { "eng_attr": "Therapeutic confirmatory (Phase III)", "chs_attr": "治疗验证性（第三阶段）", "index_num": "E.7.3", "attr_value": [ "No" ], "display_order": 136 }, { "eng_attr": "Therapeutic use (Phase IV)", "chs_attr": "治疗用途（第四阶段）", "index_num": "E.7.4", "attr_value": [ "No" ], "display_order": 137 }, { "eng_attr": "Design of the trial", "chs_attr": "试验设计", "index_num": "E.8", "attr_value": null, "display_order": 138 }, { "eng_attr": "Controlled", "chs_attr": "对照", "index_num": "E.8.1", "attr_value": [ "Yes" ], "display_order": 139 }, { "eng_attr": "Randomised", "chs_attr": "随机", "index_num": "E.8.1.1", "attr_value": [ "Yes" ], "display_order": 140 }, { "eng_attr": "Open", "chs_attr": "开启", "index_num": "E.8.1.2", "attr_value": [ "No" ], "display_order": 141 }, { "eng_attr": "Single blind", "chs_attr": "单盲", "index_num": "E.8.1.3", "attr_value": [ "No" ], "display_order": 142 }, { "eng_attr": "Double blind", "chs_attr": "双盲", "index_num": "E.8.1.4", "attr_value": [ "Yes" ], "display_order": 143 }, { "eng_attr": "Parallel group", "chs_attr": "并联组", "index_num": "E.8.1.5", "attr_value": [ "Yes" ], "display_order": 144 }, { "eng_attr": "Cross over", "chs_attr": "交叉", "index_num": "E.8.1.6", "attr_value": [ "No" ], "display_order": 145 }, { "eng_attr": "Other", "chs_attr": "其他", "index_num": "E.8.1.7", "attr_value": [ "No" ], "display_order": 146 }, { "eng_attr": "Comparator of controlled trial", "chs_attr": "对照试验比较者", "index_num": "E.8.2", "attr_value": null, "display_order": 147 }, { "eng_attr": "Other medicinal product(s)", "chs_attr": "其他药品", "index_num": "E.8.2.1", "attr_value": [ "No" ], "display_order": 148 }, { "eng_attr": "Placebo:Yes", "chs_attr": null, "index_num": "E.8.2.2", "attr_value": null, "display_order": 149 }, { "eng_attr": "Other", "chs_attr": "其他", "index_num": "E.8.2.3", "attr_value": [ "No" ], "display_order": 150 }, { "eng_attr": "Number of treatment arms in the trial", "chs_attr": "试验中治疗组的数量", "index_num": "E.8.2.4", "attr_value": [ "2" ], "display_order": 151 }, { "eng_attr": "The trial involves single site in the Member State concerned", "chs_attr": "试验涉及相关成员国中的单个站点", "index_num": "E.8.3", "attr_value": [ "No" ], "display_order": 152 }, { "eng_attr": "The trial involves multiple sites in the Member State concerned", "chs_attr": "试验涉及相关会员国的多个地点", "index_num": "E.8.4", "attr_value": [ "Yes" ], "display_order": 153 }, { "eng_attr": "Number of sites anticipated in Member State concerned", "chs_attr": "有关成员国预期的站点数量", "index_num": "E.8.4.1", "attr_value": [ "3" ], "display_order": 154 }, { "eng_attr": "The trial involves multiple Member States", "chs_attr": "试验涉及多个会员国", "index_num": "E.8.5", "attr_value": [ "No" ], "display_order": 155 }, { "eng_attr": "Trial involving sites outside the EEA", "chs_attr": "涉及EEA以外地点的试验", "index_num": "E.8.6", "attr_value": null, "display_order": 156 }, { "eng_attr": "Trial being conducted both within and outside the EEA", "chs_attr": "在欧洲经济区内外进行的试验", "index_num": "E.8.6.1", "attr_value": [ "No" ], "display_order": 157 }, { "eng_attr": "Trial being conducted completely outside of the EEA", "chs_attr": "在欧洲经济区外进行的试验", "index_num": "E.8.6.2", "attr_value": [ "No" ], "display_order": 158 }, { "eng_attr": "Trial has a data monitoring committee", "chs_attr": "试验有一个数据监控委员会", "index_num": "E.8.7", "attr_value": [ "No" ], "display_order": 159 }, { "eng_attr": "Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial", "chs_attr": "试验结束的定义和理由，不是接受最后一次探视的试验受试者", "index_num": "E.8.8", "attr_value": [ "Last visit of the last subject (LVLS)" ], "display_order": 160 }, { "eng_attr": "Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial (es)", "chs_attr": "试验结束的定义和理由，不是接受最后一次探视的试验受试者(es)", "index_num": "E.8.8", "attr_value": [ "Última visita al último paciente." ], "display_order": 161 }, { "eng_attr": "Initial estimate of the duration of the trial", "chs_attr": "试验持续时间的初步估计", "index_num": "E.8.9", "attr_value": null, "display_order": 162 }, { "eng_attr": "In the Member State concerned years", "chs_attr": "在有关成员国内的试验年", "index_num": "E.8.9.1", "attr_value": [ "0" ], "display_order": 163 }, { "eng_attr": "In the Member State concerned months", "chs_attr": "在有关成员国的试验月", "index_num": "E.8.9.1", "attr_value": [ "14" ], "display_order": 164 }, { "eng_attr": "In the Member State concerned days", "chs_attr": "在有关成员国的试验日", "index_num": "E.8.9.1", "attr_value": [ "0" ], "display_order": 165 }, { "eng_attr": "In all countries concerned by the trial years", "chs_attr": "在所有相关国家的试验年", "index_num": "E.8.9.2", "attr_value": [ "0" ], "display_order": 166 }, { "eng_attr": "In all countries concerned by the trial months", "chs_attr": "在所有相关国家的试验月", "index_num": "E.8.9.2", "attr_value": [ "14" ], "display_order": 167 }, { "eng_attr": "In all countries concerned by the trial days", "chs_attr": "在所有相关国家的试验日", "index_num": "E.8.9.2", "attr_value": [ "0" ], "display_order": 168 } ] }, "count_info": 208 }

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