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| 急!父亲治病急用的短文,求翻译 |
| 作者:佚名 发布时间:2008-11-25 16:57:33 |
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问题:Inclusion Criteria:Patients meeting all of the following criteria will be eligible for enrollment in the study:• Confirmed diagnosis of HCC according to the European Association for the Study of the Liver (EASL) criteria (see Appendix 13.2);• Known underlying HCC etiology specified by hepatitis B, hepatitis C, post alcoholic cirrhosis, or other• HCC lesion(s) which are not resectable and which are measurable by CT scan;• Progression of or non-response of HCC lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization;• No cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational;• Males or females from 18- to 75-years-old, inclusive;• Ability and willingness to provide written informed consent;• Karnofsky performance status (see Appendix 13.3) of 80% or above and expected survival of more than 12 weeks; and,Negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period.Exclusion Criteria:Patients meeting any of the following criteria will be excluded from the study:• Advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a Child-Pugh score of C (see Appendix 13.4);• Significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin >40 mol/L, evidence of bile duct obstruction, serum albumin <30 g/L, serum SGOT >5 x upper limit of normal, ANC <1.0 x 109/L, platelets <100 x 109/L, or INR >2.0;• Significant cardiac or pulmonary disease defined by New York Heart Association (NYHA) Class III or IV (see Appendix 13.5), VEF <50% by echo or MUGA, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ECG; • Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately;• Significant active infection including HIV requiring oral or parenteral anti -infective therapies;• Use of investigational drug(s) within 4 weeks of enrollment; or,Prior treatment with arginine depleting agent.
纳入标准: 病人符合下列所有标准,将有资格参加这项研究: •确诊肝癌根据欧洲联盟研究协会肝脏( easl )标准(见附录13.2 ) ; •已知的背后肝癌病因指定由B型肝炎, C型肝炎,酒精后肝硬化,或其他 •肝癌病灶(部分) ,这些是不能切除的,哪些是可以衡量的,由CT扫描; •进展或无反应的肝癌病灶后,治疗被认为是最有水准的护理服务-手术切除,射频消融术,化疗; •没有癌症治疗或手术前四周,无论是化疗,有针对性的生物学或酵素,要么批准或调查; •男性或女性,从18 -7 5年生,包容性; •有能力并愿意提供书面知情同意; •人体功能状况(见附录13.3 )的80 %以上,并预计存活超过12周,以及 负尿妊娠试验,如果女性,并愿意使用有效的避孕方法,在整个研究期间。
排除标准: 患者会议下列任何一种标准,将被排除在研究: •与时俱进,肝功能衰竭显示不受控制腹水,胸腔积液,脑病变,或Child分级评分的C (见附录13.4 ) ; •显着的肝,肾或骨髓功能障碍表示,由总胆红素> 40 mol / L时,证据的胆管阻塞,血清白蛋白< 30克/ L时,血清sgot > 5 ×上限正常的,非国大< 1.0 × 109 / L时,血小板< 100 × 109 /公升或印度卢比> 2.0 ; •显着的心脏或肺部疾病的定义,由纽约心脏协会( NYHA分级) III级或IV (见附录13.5 ) , vef < 50 %回声或muga ,还是历史上的心肌梗死在过去的6个月内,显着不稳定或心律失常证据缺血对心电图; •怀孕或哺乳妇女。注:妇女生育潜力和男子必须同意使用适当的避孕措施(荷尔蒙或障碍的方法控制生育或禁欲)之前入学的研究,并为在校学习期间的参与。应一名女子怀孕或怀疑她是怀孕,而参与这项研究中,她应该告诉她的治疗医师立刻; •显着的活动性感染,包括艾滋病毒,需要口服或注射抗感染治疗; •使用的药物, ( ) , 4周的报名,或事先与治疗精氨酸耗竭。参考资料: 如果你对Inclusion Criteria:Patients meeting all of the following criteria will be eligible for enrollment in the study:• Confirmed diagnosis of HCC according to the European Association for the Study of the Liver (EASL) criteria (see Appendix 13.2);• Known underlying HCC etiology specified by hepatitis B, hepatitis C, post alcoholic cirrhosis, or other• HCC lesion(s) which are not resectable and which are measurable by CT scan;• Progression of or non-response of HCC lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization;• No cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational;• Males or females from 18- to 75-years-old, inclusive;• Ability and willingness to provide written informed consent;• Karnofsky performance status (see Appendix 13.3) of 80% or above and expected survival of more than 12 weeks; and,Negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period.Exclusion Criteria:Patients meeting any of the following criteria will be excluded from the study:• Advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a Child-Pugh score of C (see Appendix 13.4);• Significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin >40 mol/L, evidence of bile duct obstruction, serum albumin <30 g/L, serum SGOT >5 x upper limit of normal, ANC <1.0 x 109/L, platelets <100 x 109/L, or INR >2.0;• Significant cardiac or pulmonary disease defined by New York Heart Association (NYHA) Class III or IV (see Appendix 13.5), VEF <50% by echo or MUGA, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ECG; • Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately;• Significant active infection including HIV requiring oral or parenteral anti -infective therapies;• Use of investigational drug(s) within 4 weeks of enrollment; or,Prior treatment with arginine depleting agent.这个问题有好的意见或建议,请留言
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