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Enrolled Subjects (enrolled + subject)
Selected AbstractsThe DPT-1 trial: a negative result with lessons for future type 1 diabetes preventionDIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 4 2002Professor Paolo Pozzilli Abstract The author comments on the DPT-1 Trial and why the observed negative outcome in preventing diabetes in first-degree relatives of type 1 diabetic patients by parenteral insulin administration may have occurred and what can be gathered from this large study. There were three main lessons to be learned from the DPT-1 Trial as follows. (1) Large preventive trials of type 1 diabetes are feasible in first-degree relatives of type 1 diabetic patients and other preventive approaches may be now envisaged. (2) The natural history of type 1 diabetes, at least in its final years before clinical onset, has been elucidated and reiterates the relevance of our present predictive tools (autoantibodies) for identifying individuals at risk for the disease. (3) Strict follow-up of enrolled subjects in trials permits an earlier diagnosis of the disease with less frequency of ketoacidosis and implementation of insulin therapy when higher C-peptide levels are present. DPT-1 has paved the way on how to proceed and new trials will be planned benefiting from such experience. Copyright © 2002 John Wiley & Sons, Ltd. [source] The Nutrition, Aging, and Memory in Elders (NAME) study: design and methods for a study of micronutrients and cognitive function in a homebound elderly populationINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 6 2006Tammy M. Scott Abstract Background Micronutrient status can affect cognitive function in the elderly; however, there is much to learn about the precise effects. Understanding mediating factors by which micronutrient status affects cognitive function would contribute to elders' quality of life and their ability to remain in the home. Objectives The Nutrition, Aging, and Memory in Elders (NAME) Study is designed to advance the current level of knowledge by investigating potential mediating factors by which micronutrient status contributes to cognitive impairment and central nervous system abnormalities in the elderly. NAME targets homebound elders because they are understudied and particularly at risk for poor nutritional status. Methods Subjects are community-based elders aged 60 and older, recruited through area Aging Services Access Points. The NAME core data include demographics; neuropsychological testing and activities of daily living measures; food frequency, health and behavioral questionnaires; anthropometrics; gene status; plasma micronutrients, homocysteine, and other blood determinants. A neurological examination, psychiatric examination, and brain MRI and volumetric measurements are obtained from a sub-sample. Results Preliminary data from first 300 subjects are reported. These data show that the NAME protocol is feasible and that the enrolled subjects are racially diverse, at-risk, and had similar basic demographics to the population from which they were drawn. Conclusion The goal of the NAME study is to evaluate novel relationships between nutritional factors and cognitive impairment. These data may provide important information on potential new therapeutic strategies and supplementation standards for the elderly to maintain cognitive function and potentially reduce the public health costs of dementia. Copyright © 2006 John Wiley & Sons, Ltd. [source] Etiologic yield of autistic spectrum disorders: A prospective studyAMERICAN JOURNAL OF MEDICAL GENETICS, Issue 1 2006Agatino Battaglia Abstract Studies addressing etiologic yield in childhood developmental disabilities have mainly looked at individuals with developmental delay/mental retardation. The few studies addressing the question of etiologic yield in patients with pervasive developmental disorders (PDDs) had a major drawback, in that the enrolled subjects were diagnosed as having the autistic spectrum disorders based only on history and clinical examination, and/or on unspecified instruments. In addition, only some of these patients underwent a complete laboratory evaluation. To investigate the etiologic yield of PDDs, we undertook a large prospective study on subjects selected according to very strict criteria and diagnosed as having PDD based on the present "gold standard" (ADI-R and ADOS-G), and a clinical diagnosis made by a child psychiatrist. Eighty-five (85) patients with PDD and their first degree relatives participated in this study. These patients were selected from a sample of 236 subjects who had received a clinical diagnosis of PDD at the Stella Maris Institute between March 2002 and 2005. Selection criteria for entering the study were: (1) a diagnosis of PDD (with exclusion of the Rett syndrome) confirmed after the administration of the ADI-R (autism diagnostic interview-revised) and the ADOS-G (autism diagnostic observation schedule-generic). In addition, a clinical diagnosis was made by the child psychiatrist, on the basis of presence or absence of DSM-IV symptoms of autism; (2) chronological age between 4 and 18 years; (3) IQ>30; (4) availability of both biologic parents. Patients, 65/85 (76.5%), had autism, 18/85 (21.2%) had PDD-NOS, and the remaining 2/85 (2.3%) had Asperger syndrome. Ages varied between 4 years 2 months and 12 years 5 months (mean 7.6 years), and there was a marked male preponderance (68/85). All subjects underwent various laboratory studies and neuroimaging. With respect to possible etiologic determination, a detailed history and physical examination in this group of patients with PDD was informative in 10.5% (9/85). HRB karyotype was diagnostic in one, and molecular fragile X studies in one child. Brain MRI was informative in two children (2.3%) with relative macrocrania but no neurological features; and EEG was helpful in one child, identifying a Landau,Kleffner disorder. Audiometry and brainstem auditory evoked potentials (BAEPs) showed a bilateral sensorineural loss in another child. Metabolic evaluation gave normal results in all subjects. The results suggest an evaluation paradigm with reference to etiologic determination for individuals with PDDs that does not presently justify metabolic or neuroimaging on a screening basis. Recurrence risk, treatment implications, and significant and long-lasting emotional relief for the parents suggest that serious consideration be given to clinical genetic examination, genetic testing, EEG study (during wakefulness and sleep), and audiometry, despite a relatively low yield. © 2006 Wiley-Liss, Inc. [source] Serum trace element levels in COPD patient: The relation between trace element supplementation and period of mechanical ventilation in a randomized controlled trialRESPIROLOGY, Issue 8 2009May EL-ATTAR ABSTRACT Background and objective: Many trace elements play important roles in activating or inhibiting enzymatic reactions, by competing with other elements and metalloproteins for binding sites, by affecting the permeability of cell membranes and by other mechanisms. They play important roles in the oxidant/antioxidant balance. As such, trace elements are thought to be involved directly or indirectly in the pathogenesis of several diseases. The aim of the present study is to investigate the effect trace elements (Se, Mn and Zn) intravenously administered on the period the COPD patients spend on mechanical ventilation. Methods: In a randomized double-blinded controlled trial a set of 120 subjects (40 normal volunteers and 80 COPD) were recruited. Serum concentration levels of Se, Mn and Zn were determined for all enrolled subjects with Inductively Coupled Plasma spectroscopy. COPD patients received intravenous supplementation of the above trace elements and the period the patients spent on mechanical ventilation was determined. Results: There was a significant reduction (P = 0.013) in the period the patients with COPD spent on the mechanical ventilation when received intravenous supplementation (9.4 ± 7.3 days) compared with the COPD patients who received placebo (17.8 ± 7.6 days). Conclusions: Trace element (Se, Mn and Zn) status is altered in critically ill patients with COPD. The supplementation achieved a reduction in the period those patients spent on the mechanical ventilation. A larger multi-centre trial is required to confirm this preventive effect and to explore its applicability to other critical care conditions. [source] Routine Screening for Asymptomatic Abdominal Aortic Aneurysm in High-risk Patients Is Not Recommended in Emergency Departments That Are Frequently CrowdedACADEMIC EMERGENCY MEDICINE, Issue 11 2009Beatrice Hoffmann MD Abstract Objectives:, The objectives were to examine the feasibility of offering abdominal aortic aneurysm (AAA) screening to consecutive, asymptomatic high-risk patients in a busy emergency department (ED) and to compare the prevalence of undetected AAA among ED patients to the prevalence among similarly aged men from the general population. Methods:, A prospective cohort study was conducted at an academic community ED with an annual census of 58,000 patients. Dedicated study coordinators attempted to approach all consecutive male ED patients >50 years who presented in June,August 2007 during hours of high patient volume. To be eligible, older males had to have a smoking history or a family history of AAA. Patients were excluded if they presented with AAA symptoms, had a previous history of AAA screening or repair, had hemodynamic instability, or had an altered mental status. Study coordinators completed a brief interview with all enrolled subjects to obtain demographic and health information. A credentialed ED provider performed the ultrasound (US) screening exam and documented all findings. The US director reviewed representative images of the sonographic exam for correct visualization and measurement during quality assurance. The ED sonographers also completed a survey regarding their attitudes toward AAA screening in the ED. The primary study outcomes were the feasibility of AAA screening in the ED (screening rate, enrollment rate, US success rate, and providers' opinions) and the prevalence of AAA (aortic diameter of ,3.0 cm) in the study sample. Results:, During the 12-week study period, the study coordinators successfully approached 96% (700/729) of males > 50 years who were in the ED during study enrollment hours. Of those approached, 278 were eligible (40%), 25% were ineligible, 20% were not at high risk, and for 15% we could not determine risk factor status because of altered mental status. Of the 278 eligible, 196 (70%) underwent an US exam; 10% were not scanned because the providers were too busy, and 20% declined participation. Of those scanned, the ED sonographer was able to completely visualize and correctly measure the abdominal aortas of 71% of subjects. The prevalence rate of AAA in the study sample was 5.7% (95% confidence interval [CI] = 1.9% to 9.6%), similar to reported rates of 6 or 7% in other studies. More than half of the ED sonographers reported that US screening for AAA improved the quality of ED care (58%) and patient satisfaction (63%). However, 47% reported that AAA screening reduced ED efficiency, and 74% felt that the ED was not an appropriate setting for routine AAA screening. Conclusions:, Routine screening for asymptomatic AAA required substantial ED resources for a relatively low success rate of completed screens. The prevalence rate of AAA in our ED sample was not significantly different than prevalence estimates obtained from older men in the general population. ED sonographers reported benefits of screening in terms of improving the quality of emergency care and patient satisfaction, but also reported that it reduced operational efficiency. For EDs that have problems with crowding, we do not recommend implementing a routine screening program for AAA, even among high-risk patients. [source] A Multicenter Comparison of Tap Water versus Sterile Saline for Wound IrrigationACADEMIC EMERGENCY MEDICINE, Issue 5 2007Ronald M. Moscati MD ObjectivesTo compare wound infection rates for irrigation with tap water versus sterile saline before closure of wounds in the emergency department. MethodsThe study was a multicenter, prospective, randomized trial conducted at two Level 1 urban hospitals and a suburban community hospital. Subjects were a convenience sample of adults presenting with acute simple lacerations requiring sutures or staples. Subjects were randomized to irrigation in a sink with tap water or with normal saline using a sterile syringe. Wounds were closed in the standard fashion. Subjects were asked to return to the emergency department for suture removal. Those who did not return were contacted by telephone. Wounds were considered infected if there was early removal of sutures or staples, if there was irrigation and drainage of the wound, or if the subject needed to be placed on antibiotics. Equivalence of the groups was met if there was less than a doubling of the infection rate. ResultsA total of 715 subjects were enrolled in the study. Follow-up data were obtained on 634 (88%) of enrolled subjects. Twelve (4%) of the 300 subjects in the tap water group had wound infections, compared with 11 (3.3%) of the 334 subjects in the saline group. The relative risk was 1.21 (95% confidence interval = 0.5 to 2.7). ConclusionsEquivalent rates of wound infection were found using either irrigant. The results of this multicenter trial evaluating tap water as an irrigant agree with those from previous single institution trials. [source] | ||||||||||