Summary Background Hepatic veno-occlusive disease is a leading cause of morbidity and mortality after haemopoietic stem-cell transplantation (HSCT). We aimed to assess whether defibrotide can reduce ...the incidence of veno-occlusive disease in this setting. Methods In our phase 3 open-label, randomised controlled trial, we enrolled patients at 28 European university hospitals or academic medical centres. Eligible patients were younger than 18 years, had undergone myeloablative conditioning before allogeneic or autologous HSCT, and had one or more risk factor for veno-occlusive disease based on modified Seattle criteria. We centrally assigned eligible participants on the basis of a computer-generated randomisation sequence (1:1), stratified by centre and presence of osteopetrosis, to receive intravenous defibrotide prophylaxis (treatment group) or not (control group). The primary endpoint was incidence of veno-occlusive disease by 30 days after HSCT, adjudicated by a masked, independent review committee, in eligible patients who consented to randomisation (intention-to-treat population), and was assessed with a competing risk approach. Patients in either group who developed veno-occlusive disease received defibrotide for treatment. We assessed adverse events to 180 days after HSCT in all patients who received allocated prophylaxis. This trial is registered with ClinicalTrials.gov , number NCT00272948. Findings Between Jan 25, 2006, and Jan 29, 2009, we enrolled 356 eligible patients to the intention-to-treat population. 22 (12%) of 180 patients randomly allocated to the defibrotide group had veno-occlusive disease by 30 days after HSCT compared with 35 (20%) of 176 controls (risk difference −7·7%, 95% CI −15·3 to −0·1; Z test for competing risk analysis p=0·0488; log-rank test p=0·0507). 154 (87%) of 177 patients in the defibrotide group had adverse events by day 180 compared with 155 (88%) of 176 controls. Interpretation Defibrotide prophylaxis seems to reduce incidence of veno-occlusive disease and is well tolerated. Thus, such prophylaxis could present a useful clinical option for this serious complication of HSCT. Funding Gentium SpA, European Group for Blood and Marrow Transplantation.
Abstract Objectives and aims Laser therapy for penile carcinoma is commonly used despite high recurrence rates of up to 48%. The aim of our study was to investigate the long-term recurrence rate of ...patients treated by fluorescence-guided laser therapy for penile carcinoma and its impact on oncologic outcome. Patients and methods Between 1999 and 2005, a total of 26 patients with premalignant carcinoma in situ (Tis) ( n = 11) or invasive penile carcinoma ( n = 15) were treated by fluorescence-guided laser therapy in our center. The mean follow-up was 71.1 months (range 41–104 months). Recurrence rate, time to recurrence, and impact on survival was investigated for Tis patients and penile carcinoma patients separately. Results No patient died tumor-associated recurrence during follow-up. No local progression of T stage was observed in patients with Tis tumor. In the group with invasive penile cancer, there were 4 (15.4%) local recurrences. However, 3 of them occurred after more than 3 years and, therefore, are more likely to be considered as “de novo” carcinoma. No intra- or perioperative side effects of photodynamic diagnosis (PDD) were observed. Conclusions Local recurrence rate of laser therapy can be reduced by fluorescence guidance without impairing cosmetic or functional results. The necessary equipment is available in many centers that perform PDD for urothelial bladder cancer. PDD, therefore, can be considered to be cost-effective and easy to perform. Prospective multi-center studies to directly compare recurrence rates between white light and fluorescence-guided laser therapy for penile carcinoma are required.
Bourdon-type pressure devices are used to detect pressure in industrial installations and pressure monitoring systems. Bourdon tubes are manufactured in various engineering shapes like circular-C, ...helix, and spiral, to serve the use of this tube in terms of positioning and accuracy. The tip of the Bordoun tube is a pressure-sensitive element. The applied input pressure causes the tube tip to be shifted or translated from the initial position. In this study, the pressure measurement in Bordoun tube was simulated at different sections and different axial ratios of multiple metals to obtain the best tube tilp deviation using the Solidworks program. Simulation results expressing the differentiation of tip travel values using four materials, three axial ratios, and four cross-section types. The results show that best material in terms of maximum tip travel was Zinc AZ-12, and for any material and regular wall thickness, the axial ratio (0.3) gives the best response. Also, the results show other materials' response and effect of change axial ratio.
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