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Crossover Trials (crossover + trials)
Selected AbstractsS25.4: Time-course Analysis in Crossover TrialsBIOMETRICAL JOURNAL, Issue S1 2004Berthold Schneider No abstract is available for this article. [source] Continuous subcutaneous insulin infusion with short-acting insulin analogues or human regular insulin: efficacy, safety, quality of life, and cost-effectivenessDIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 3 2004Régis Pierre Radermecker Abstract Portable insulin infusion devices are effective and safe insulin delivery systems for managing diabetes mellitus, especially type 1 diabetes. Rapidly absorbed insulin analogues, such as insulin lispro or insulin aspart, may offer an advantage over regular human insulin for insulin pumps. Several open-label randomised crossover trials demonstrated that continuous subcutaneous insulin infusion (CSII) with insulin lispro provided a better control of postprandial hyperglycaemia and a slightly but significantly lower glycated haemoglobin level, with lower daily insulin requirement and similar or even less hypoglycaemic episodes. A CSII study comparing insulin lispro and insulin aspart demonstrated similar results with the two analogues, and better results than those with regular insulin. Because these analogues have a quicker onset and a shorter duration of action than regular insulin, one might expect an earlier and greater metabolic deterioration in case of CSII interruption, but a more rapid correction of metabolic abnormalities after insulin boluses when reactivating the pump. These expectations were confirmed in randomised protocols comparing the metabolic changes occurring during and after CSII interruption of various durations when the pump infused either insulin lispro or regular insulin. The extra cost resulting from the use of CSII and insulin analogues in diabetes management should be compensated for by better metabolic control and quality of life. In conclusion, CSII delivering fast-acting insulin analogues may be considered as one of the best methods to replace insulin in a physiological manner by mimicking meal and basal insulin requirements, without higher risk of hypoglycaemia or ketoacidosis in well-educated diabetic patients. Copyright © 2004 John Wiley & Sons, Ltd. [source] Safety characteristics of gadobenate dimeglumine: Clinical experience from intra- and interindividual comparison studies with gadopentetate dimeglumineJOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 6 2006Frank G. Shellock PhD Abstract Purpose To evaluate the safety and tolerability of gadobenate dimeglumine (Gd-BOPTA) relative to that of gadopentetate dimeglumine (Gd-DTPA) in patients and volunteers undergoing MRI for various clinical conditions. Materials and Methods A total of 924 subjects were enrolled in 10 clinical trials in which Gd-BOPTA was compared with Gd-DTPA. Of these subjects, 893 were patients with known or suspected disease and 31 were healthy adult volunteers. Of the 893 patients, 174 were pediatric subjects (aged two days to 17 years) referred for MRI of the brain or spine. Safety evaluations included monitoring vital signs, laboratory values, and adverse events (AE). Results The rate of AE in adults was similar between the two agents (Gd-BOPTA: 51/561, 9.1%; Gd-DTPA: 33/472, 7.0%; P = 0.22). In parallel-group studies in which subjects were randomized to either agent, the rate of AE was 10.9% for Gd-BOPTA and 7.9% for Gd-DTPA (P = 0.21). In the subset of subjects receiving both agents in intraindividual crossover trials, the rate of AE was 8.0% for Gd-BOPTA and 8.5% for Gd-DTPA (P = 0.84). Results of other safety assessments (laboratory tests, vital signs) were similar for the two agents. Conclusion The safety profile of Gd-BOPTA is similar to Gd-DTPA in patients and volunteers. Both compounds are equally well-tolerated in patients with various disease states undergoing MRI. J. Magn. Reson. Imaging 2006. © 2006 Wiley-Liss, Inc. [source] Sacral nerve stimulation for fecal incontinence and constipation in adults: A short version cochrane review,,NEUROUROLOGY AND URODYNAMICS, Issue 3 2008G. Mowatt Background Fecal incontinence and constipation are disabling conditions that reduce quality of life. If conservative treatment fails, one option is sacral nerve stimulation (SNS), a minimally invasive technique allowing modulation of the nerves and muscles of the pelvic floor and hindgut. Objectives To assess the effects of SNS for fecal incontinence and constipation in adults. Search strategy We searched the Cochrane Incontinence Group Specialized Trials Register (searched 24 April 2007) and the reference lists of relevant articles. Selection criteria All randomized or quasi-randomized trials assessing the effects of SNS for fecal incontinence or constipation in adults. Data collection and analysis Two review authors independently screened the search results, assessed the methodological quality of the included studies, and undertook data extraction. Main results Three crossover studies were included. Two, enrolling 34 (Leroi) and two participants (Vaizey), assessed the effects of SNS for fecal incontinence, and one (Kenefick), enrolling two participants, assessed SNS for constipation. In the study by Leroi, following the crossover period, participants, while still blinded, chose the period of stimulation they had preferred. Outcomes at different time points were reported separately for 19 participants who preferred the "on" and five who preferred the "off" period. For the group of 19, the median (range) episodes of fecal incontinence per week fell from 1.7 (0,9) during the "off" period to 0.7 (0,5) during the "on" period; for the group of five, however, the median (range) rose from 1.7 (0,11) during the "off" period compared with 3.7 (0,11) during the "on" period. Vaizey reported an average of six, and one, episodes of fecal incontinence per week during the "off" and "on" periods, respectively. Leroi reported that four of 27 participants experienced an adverse event resulting in removal of the stimulator; Vaizey did not report adverse events. For SNS for constipation, during the "off" crossover period the participants experienced an average of two bowel movements per week, compared with five during the "on" period. Abdominal pain and bloating occurred 79% of the time during the "off" period compared with 33% during the "on" period. No adverse events occurred. Authors' conclusions The very limited evidence from the included studies suggests that SNS can improve continence in selected people with fecal incontinence, and reduce symptoms in selected people with constipation. However, temporary, percutaneous stimulation for a 2,3-week period does not always successfully identify those for whom a permanent implant will be beneficial. Larger, good quality randomized crossover trials are needed to allow the effects of SNS for these conditions to be assessed with more certainty. Neurourol. Urodynam. 27:155,161, 2008. © 2008 Wiley-Liss, Inc. [source] | ||||||||||