ABSTRACT Purpose As a classical xenotransplantation model, porcine kidneys have been transplanted into the lower abdomen of non-human primates. However, we have improved upon this model by using size-matched grafting in the orthotopic position. The beneficial aspects and surgical details of our method are reported herein. Methods Donors were two newborn pigs (weighting 5 to 6 kg) and recipients were two cynomolgus monkeys (weighting, approximately, 7 kg). After bilateral nephrectomy, kidneys were cold-transported in Euro-Collins solution. The porcine kidney was transplanted to the site of a left nephrectomy and fixed to the peritoneum. Results Kidneys transplanted to the lower abdomen by the conventional method were more susceptible to torsion of the renal vein (two cases). In contrast, early-stage blood flow insufficiency did not occur in orthotopic transplants of theleft kidney. Conclusions Size-matched porcine-primate renal grafting using our method of transplanting tothe natural position of the kidneys contributes to stable post-transplant blood flow to the kidney.

摘要 目的 估算临床试验中参与者理解知情同意不同组成部分的比例。 方法 系统回顾PubMed、Scopus和Google Scholar来识别相关研究。使用随机影响模型执行研究结果荟萃分析，以便将异质性考虑在内。 结果 分析包括评估135组参与者的103项研究。参与者理解知情同意组成部分...

Résumé Objectif Estimer la proportion des participants à des essais cliniques qui comprennent les différents composants du consentement éclairé. Méthodes Les études pertinentes ont été identifiées par une revue systématique de PubMed, Scopus et Google Scholar et par l'examen manuel des listes des références des publications allant jusqu'à octobre 2013. Une méta-analyse des résultats de l'étude a été réalisée à l'aide du modèle à effets aléatoires pour tenir compte de l'hétérogénéité. Résultats L'analyse a inclus 103 études évaluant 135 cohortes de participants. La proportion regroupée des participants qui ont compris les composants du consentement éclairé é...

Резюме Цель Определить долю участников клинических исследований, которые понимают различные детали информированного согласия. Методы Соответствующ...

Objective To estimate the proportion of participants in clinical trials who understand different components of informed consent. Methods Relevant studies were identified by a systematic review of PubMed, Scopus and Google Scholar and by manually reviewing reference lists for publications up to October 2013. A meta-analysis of study results was performed using a random-effects model to take account of heterogeneity. Findings The analysis included 103 studies evaluating 135 cohorts of participants. The pooled proportion of participants who understood components of informed consent was 75.8% for freedom to withdraw at any time, 74.7% for the nature of study, 74.7% for the voluntary nature of participation, 74.0% for potential benefits, 69.6% for the study’s purpose, 67.0% for potential risks and side-effects, 66.2% for confidentiality, 64.1% for the availability of alternative treatment if withdrawn, 62.9% for knowing that treatments were being compared, 53.3% for placebo and 52.1% for randomization. Most participants, 62.4%, had no therapeutic misconceptions and 54.9% could name at least one risk. Subgroup and meta-regression analyses identified covariates, such as age, educational level, critical illness, the study phase and location, that significantly affected understanding and indicated that the proportion of participants who understood informed consent had not increased over 30 years. Conclusion The proportion of participants in clinical trials who understood different components of informed consent varied from 52.1% to 75.8%. Investigators could do more to help participants achieve a complete understanding.

ملخص الغرض تقدير نسبة المشاركين في التجارب السريرية الذين يفهمون العناصر المختلفة للموافقة المستنيرة. الطريقة تم تحديد الدراسات ذات الصلة عن طريق استعرا...

Resumen Objetivo Estimar la proporción de participantes de ensayos clínicos que comprende los distintos componentes del consentimiento informado. Métodos Se identificaron los estudios pertinentes mediante una revisión sistemática de PubMed, Scopus y Google Scholar y el examen manual de listas de referencia a fin de hallar publicaciones anteriores a octubre de 2013. Se realizó un metanálisis de los resultados del estudio mediante un modelo de efectos aleatorios para tener en cuenta la heterogeneidad. Resultados El análisis incluyó 103 estudios que evaluaron 135 cohortes de participantes. La proporción combinada de participantes que entendía los componentes del consentimiento informado fue del 75,8 % para la libertad de retirarse en cualquier momento, 74,7 % para la naturaleza del estudio, 74,7 % para el carácter voluntario de la participación, 74,0 % para los beneficios potenciales, 69,6 % para el propósito del estudio, 67,0 % para los riesgos y efectos secundarios potenciales, 66,2 % para la confidencialidad, 64,1 % para la disponibilidad de tratamiento alternativo si el paciente se retira, 62,9 % para saber que se comparaban tratamientos, 53,3 % para el placebo y 52,1 % para la aleatorización. La mayoría de los participantes, el 62,4 %, no tenía una idea equivocada sobre la terapia y el 54,9 % no fue capaz de nombrar al menos un riesgo. Los análisis de subgrupos y la metarregresión identificaron covariables, como edad, nivel educativo, enfermedad crítica, fase de estudio y ubicación, que influían considerablemente en la comprensión y señalaron que la proporción de participantes que entendía el consentimiento informado no había aumentado en 30 años. Conclusión La proporción de participantes de ensayos clínicos que entendía los diferentes componentes del consentimiento informado varió del 52,1 % al 75,8 %. Los investigadores podrían realizar esfuerzos mayores para ayudar a los pacientes a lograr una comprensión total.

Iatrogenous transmission of Trypanosoma cruziby blood transfusion was suggested as a potential risk by Pellegrino (1949). Seropositive blood donors in Mexico were first reported in 1978, however, limited information is available due to small sampling, the use of heterogeneous serologic assays, and geographically limited studies. A wide survey carried out in 18 out of the 32 states of Mexico, showed a national mean of 1.6% seropositive among 64,969 donors, ranging from 0.2 to 2.8%. In the present study, we have screened 43,048 voluntary blood donors in a period of five years at the Instituto Nacional de Cardiología I. Chávez, a concentration hospital located in Mexico city which serves mainly the metropolitan area and accepts from all over the country. Standardized ELISA and IIF were used to identify seropositive individuals in addition to hemoculture, PCR and standard 12 lead ECG tests that were applied to a group of seropositive patients (29/161). The result showed a seropositivity of 0.37% (161/43,048). From the group of seropositive individuals 40% (12/29) were potential carriers of T. cruzi at the donation time and 5/29 had subclinical ECG abnormalities. Parasitological tests performed in 70 erythrocyte and platelet fractions from seropositive units (70/161) showed negative results. Our findings strongly support T. cruzi screening in the transfusion medicine practice and identify subclinical heart disease among seropositive blood donors.

In México the first human chronic chagasic case was recognized in 1940. In spite of an increasing number of cases detected since that time, Chagas disease in México has been poorly documented. In the present work we studied 617 volunteers subjects living in high and low endemic regions of Trypanosoma cruzi infection with seroprevalence of 22% and 4% respectively. Hemoculture performed in those seropositive subjects failed to demonstrate circulating parasites, however polymerase chain reaction identified up to 60% of them as positives. A higher level of anti-T. cruzi antibodies was observed in seropositive residents in high endemic region, in spite of similar parasite persistence (p < 0.05). On standard 12 leads electrocardiogram (ECG) 20% to 22% seropositive individuals from either region showed right bundle branch block or ventricular extrasystoles which were more prevalent in seropositive than in seronegative individuals (p < 0.05). In conclusion, the frequency or type of ECG abnormality was influenced by serologic status but not by endemicity or parasite persistence. Furthermore, Mexican indeterminate patients have a similar ECG pattern to those reported in South America.