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Informed consent, parental awareness, and reasons for participating in a randomised controlled study
M van Stuijvenberg MH Suur S de Vos GC Tjiang EW Steyerberg G Derksen-Lubsen HA Moll 《Archives of disease in childhood》1998,79(2):120-125
BACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A questionnaire was sent to parents who volunteered their child (230 children) for a randomised, double blind, placebo controlled trial of ibuprofen syrup to prevent recurrent febrile seizures. RESULTS: 181 (79%) parents responded. On average, 73% of parents were aware of the major study characteristics. A few had difficulty understanding the information provided. Major factors in parents granting approval were the contribution to clinical science (51%) and benefit to the child (32%). Sociodemographic status did not influence initial participation but west European origin of the father was associated with willingness to participate in future trials. 89% of participants felt positive about the informed consent procedure; however, 25% stated that they felt obliged to participate. Although their reasons for granting approval and their evaluation of the informed consent procedure did not differ, relatively more were hesitant about participating in future. Parents appreciated the investigator being on call 24 hours a day (38%) and the extra medical care and information provided (37%) as advantages of participation. Disadvantages were mainly the time consuming aspects and the work involved (23%). CONCLUSIONS: Parents' understanding of trial characteristics might be improved by designing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents. Adequate measures should be taken to avoid parents feeling obliged to participate, rather than giving true informed consent. 相似文献
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The pistachio is regarded as a relevant source of biologically active components that, compared to other nuts, possess a healthier nutritional profile with low-fat content composed mainly of monounsaturated fatty acids, a high source of vegetable protein and dietary fibre, remarkable content of minerals, especially potassium, and an excellent source of vitamins, such as vitamins C and E. A rich composition in terms of phytochemicals, such as tocopherols, carotenoids, and, importantly, phenolic compounds, makes pistachio a powerful food to explore its involvement in the prevention of prevalent pathologies. Although pistachio has been less explored than other nuts (walnut, almonds, hazelnut, etc.), many studies provide evidence of its beneficial effects on CVD risk factors beyond the lipid-lowering effect. The present review gathers recent data regarding the most beneficial effects of pistachio on lipid and glucose homeostasis, endothelial function, oxidative stress, and inflammation that essentially convey a protective/preventive effect on the onset of pathological conditions, such as obesity, type 2 diabetes, CVD, and cancer. Likewise, the influence of pistachio consumption on gut microbiota is reviewed with promising results. However, population nut consumption does not meet current intake recommendations due to the extended belief that they are fattening products, their high cost, or teething problems, among the most critical barriers, which would be solved with more research and information. 相似文献
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Recovery of T cell subsets after autologous bone marrow transplantation is mainly due to proliferation of mature T cells in the graft 总被引:3,自引:3,他引:3
de Gast GC; Verdonck LF; Middeldorp JM; The TH; Hekker A; v.d. Linden JA; Kreeft HA; Bast BJ 《Blood》1985,66(2):428-431
In 22 patients with malignancies, treated with high-dose chemoradiotherapy and autologous bone marrow transplantation (BMT), peripheral blood T cell subsets and functions were studied. In ten cytomegalovirus (CMV)-negative patients, CD4+ and CD8+ T cells (representing T cells of the helper/inducer phenotype and T cells of the suppressor/cytotoxic phenotype, respectively), recovered slowly and simultaneously. In 12 CMV-positive patients, however, CD8+ T cells recovered more rapidly than CD4+ T cells and rose to increased counts. No T cells with an immature phenotype (CD1+, OKT6+) were observed. Lymphocyte stimulation by herpes simplex virus infected fibroblasts (and by CMV-infected fibroblasts in CMV-positive patients) in contrast remained high and even increased after BMT in both groups. These data indicate that T cell recovery after autologous BMT is mainly due to proliferation of mature T cells present in the BM graft and not to generation of new T cells from T cell precursors. 相似文献
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目的观察脐带间充质干细胞(UC-MSC)治疗遗传性痉挛性截瘫(HSP)的临床疗效及安全性。方法2010年9月及2011年4月,分别给予一HSP家系父子2人行UC-MSC鞘内注射治疗,两个疗程,每次1×106 cells/Kg,每周1次,4次为1个疗程。采用改良的Ashworth肌张力分级标准(MAS)、国际合作共济失调评分量表(ICARS)及日常生活量表(ADL),对患者治疗前后神经功能、日常生活能力进行评定。结果第一疗程结束1个月与治疗前比较,2人MAS分级、ICARS及ADL评分均降低,两人行走站立稳定性及言语流利程度较治疗前改善;第二疗程结束后1个月与该疗程治疗前比较,2人ICARS及ADL评分降低,儿子肌张力进一步降低,父亲双上肢共济失调减轻。2人治疗后均未见明显不良反应发生。末次治疗结束后随访20个月,父、子俩分别于第二疗程治疗结束7个月及8个月后,症状继续加重。结论 UC-MSC鞘内注射治疗是安全的,可在一定时间内一定程度上减轻患者临床症状,提高患者生活质量,延缓疾病进展,但疗效不能持久。 相似文献
20.
Sexual behavior survey and screening for chlamydia and gonorrhea in university students in South Korea 总被引:1,自引:0,他引:1
SEUNG-JU LEE YONG-HYUN CHO U-SYN HA SAE WOONG KIM MOON SOO YOON KYUNGHEE BAE 《International journal of urology》2005,12(2):187-193
BACKGROUND: The purpose of the present study was to define the prevalence of genital Chlamydia trachomatis and Neisseria gonorrhoeae infections and status of sexual risk behavior among university students (18-25 years old) in the capital region of South Korea. METHODS: Participants filled out a self-administered questionnaire related to sexuality. First-void urine was analyzed for chlamydial and gonococcal infection by strand displacement amplification (BDProbTecET, BD Diagnostic Systems, MD). RESULTS: A total of 622 students from 15 colleges in three universities took part in the study. The median age was 21 and 39.1% of them reported having sexual intercourse at least once. The prevalence of C. trachomatis among sexually active men and women was 8.4% and 10.6%, respectively. Gonococcal infection was noted in one symptomatic male. Factors significantly associated with infection were the number of sexual partners during past year and lifetime and condom use. CONCLUSIONS: This is the first sexually transmitted infection (STI) screening in university students in South Korea. Urine-based STI screening was both feasible and acceptable in university students in South Korea. It should be considered a routine part of programs to control STI nationally. 相似文献