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Selected AbstractsEfficacy and safety of a new single-dose terbinafine 1% formulation in patients with tinea pedis (athlete's foot): a randomized, double-blind, placebo-controlled studyJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 10 2006JP Ortonne Abstract Background, Tinea pedis is a common dermatophyte infection with frequent recurrences. Terbinafine (presently used as a 1-week topical treatment of tinea pedis) is now available in a novel topical solution (film-forming solution , FFS), developed to allow single application. Objectives, To demonstrate the efficacy and safety of terbinafine 1% FFS in a randomized, double-blind, placebo-controlled, phase III trial, and to determine relapse or re-infection rate of tinea pedis at 12 weeks. Patients/methods, Fifty-four centres (27 in France; 27 in Germany) enrolled 273 evaluable patients (2 : 1 randomization). Patients applied terbinafine 1% FFS or placebo only once between, under and over the toes, soles and sides of both feet. Efficacy assessments included direct microscopy, mycological culture, and clinical signs and symptoms at baseline, and at weeks 1, 6 and 12 after the single drug application. Results, Effective treatment (negative mycology plus absent/minimal symptoms) at week 6 in the terbinafine 1% FFS group was 63%; vehicle was 17% (P 0.0001). Mycological cure was 72% in the terbinafine group and 21% in the placebo (P 0.0001) at week 6. Clinical signs/symptoms decreased significantly in the active group compared to the placebo. The self-assessment of itching and burning sensation by the patient showed a clear reduction in symptoms starting 15 min after treatment application (this could be attributed to the cooling effect of the FFS). Recurrence (positive culture at 3 months) occurred in 12.5% of the effectively treated patients at week 6 in the terbinafine group. FFS was well tolerated. Conclusion, Terbinafine 1% FFS, single dose application is an effective, safe and convenient treatment for tinea pedis. The relapse/re-infection rate 3 months after the end of single-dose therapy is similar to that previously demonstrated in a study using terbinafine 1% cream for 7 days. [source] Patient preferences for managing asthma: results from a discrete choice experimentHEALTH ECONOMICS, Issue 7 2007Madeleine T. King Abstract Effective control of asthma requires regular preventive medication. Poor medication adherence suggests that patient preferences for medications may differ from the concerns of the prescribing clinicians. This study investigated patient preferences for preventive medications across symptom control, daily activities, medication side-effects, convenience and costs, using a discrete choice experiment embedded in a randomized clinical trial involving patients with mild,moderate persistent asthma. The present data were collected after patients had received 6 weeks' treatment with one of two drugs. Three choice options were presented, to continue with the current drug, to change to an alternative, hypothetical drug, or to take no preventive medication. Analysis used random parameter multinomial logit. Most respondents chose to continue with their current drug in most choice situations but this tendency differed depending on which medication they had been allocated. Respondents valued their ability to participate in usual daily activities and sport, preferred minimal symptoms, and were less likely to choose drugs with side-effects. Cost was also significant, but other convenience attributes were not. Demographic characteristics did not improve the model fit. This study illustrates how discrete choice experiments may be embedded in a clinical trial to provide insights into patient preferences. Copyright © 2007 John Wiley & Sons, Ltd. [source] Exclusive use of acid citrate dextrose for anticoagulation during extracorporeal photopheresis in patients with contraindications to heparin: An effective protocol,JOURNAL OF CLINICAL APHERESIS, Issue 2 2008Elena Nedelcu Abstract Extracorporeal photopheresis (ECP) routinely uses heparin for anticoagulation. For patients with contraindications to heparin, alternative anticoagulation using acid citrate dextrose (ACD-A) has been reported to be safe and effective. However, detailed ECP protocols that exclusively use ACD-A anticoagulation and minimize citrate toxicity have not yet been published. We report a protocol that completely replaces heparin with ACD-A for ECP, which was developed at the University of California, Los Angeles (UCLA), and our experience since its implementation. ECP was performed with the UVAR XTS photopheresis system using ACD-A and control of the rate of citrate infusion. Calcium gluconate solution was administered prophylactically and as needed for symptoms of citrate toxicity. The medical records of patients who underwent ECP using the ACD-A protocol between January 2003 and July 2006 were reviewed. The incidence and severity of citrate toxicity and the technical data for all procedures were analyzed. During this period, 94 ECP procedures were performed with ACD-A anticoagulation on five patients. All patients tolerated the procedures well without significant complications. Only minimal symptoms of citrate toxicity (grade 1) were observed in 24.5% of all procedures; symptoms resolved promptly following administration of additional calcium gluconate. In conclusion, an effective protocol for ECP using ACD-A anticoagulation exclusively in patients with contraindications to heparin employs continuous monitoring of flow rates and prophylactic administration of calcium gluconate to minimize citrate toxicity. J. Clin. Apheresis, 2008. Published 2008 Wiley-Liss, Inc. [source] Abdominal hernias in pregnancyJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 2 2009Goran Augustin Abstract A hernia is an area of weakness or complete disruption of the fibromuscular tissues of the body wall. In addition to the body wall, hernias can occur in the diaphragm, pelvic wall, perineum, pelvic floor, and internal abdominal viscera (hernias through omental or mesenteric defects, ligaments and folds). Surgical repair of different types of hernia is the most common general surgical procedure with more than 20 million hernioplasties performed each year. Abdominal wall hernias are not common during pregnancy. Hernias can be symptomless or have minimal symptoms, including slight discomfort or pain. Such hernias are not life-threatening and should be controlled on regular basis. After spontaneous delivery and uterine involution, they should be repaired on an elective basis. It is of utmost importance for a clinician to diagnose emergent situations, which include incarceration, strangulation and perforation caused by hernia because consultation with a surgeon and emergency operation are mandatory. There is still no consensus for irreducible hernia during pregnancy, but complications during pregnancy outweigh elective operation. Therefore, hernioplasty is recommended during pregnancy, especially in early gestation. [source] Unusual case of Morgagni hernia associated with malrotationANZ JOURNAL OF SURGERY, Issue 9 2003Fiona G . Court Morgagni herniae are rare congenital diaphragmatic hernia, which normally present late in adult life with minimal symptoms. They are always associated with a peritoneal hernial sac, and often contain transverse colon or stomach. We present an unusual case of a Morgagni hernia containing caecum in an 81-year-old woman, post ruptured aortic aneurysm repair. [source] Medication adherence skills training for middle-aged and elderly adults with bipolar disorder: development and pilot studyBIPOLAR DISORDERS, Issue 6 2007Colin A Depp Objectives:, To present the rationale, development, and pilot study of a medication adherence skills training (MAST-BD) intervention for older adults with bipolar disorder (BPD). We developed a 12-week manualized group intervention that combined educational, motivational, medication management skills and symptom management training adapted for older adults. Methods:, Among 21 older outpatients with BPD (mean age = 60 years; SD = 6), the feasibility and acceptability of MAST-BD were assessed in a quasi-experimental clinical trial. We also obtained preliminary effect sizes associated with pre,post change on measures of self-reported adherence to psychiatric medications, performance-based medication management ability, attitudes toward medication, depressive and manic symptoms, and health-related quality of life. Results:, At baseline, 55% of participants reported recent non-adherence to psychiatric medications and were, on average, suffering from moderately severe depressive symptoms and minimal symptoms of mania. A total of 76% of participants completed the intervention, and 86% of sessions were attended by completers. Participants reported high levels of satisfaction with the intervention and manual. Pre,post improvement by small to medium effect sizes (Cohen's d = 0.30,0.57) was seen in medication adherence, medication management ability, depressive symptoms, and selected indices of health-related quality of life. Conclusions:, Notwithstanding the limitations of this small preliminary study, the results are encouraging in that the MAST-BD intervention was feasible, acceptable to patients, and associated with improvement in key outcomes. Suggestions for further development of medication adherence interventions for this neglected group of patients are discussed. [source] |