A randomised trial of intrapericardial bleomycin for malignant pericardial effusion with lung cancer (JCOG9811)

Safety and efficacy of intrapericardial (ipc) instillation of bleomycin (BLM) following pericardial drainage in patients with malignant pericardial effusion (MPE) remain unclear. Patients with pathologically documented lung cancer, who had undergone pericardial drainage for MPE within 72 h of enrolment, were randomised to either arm A (observation alone after drainage) or arm B (ipc BLM at 15 mg, followed by additional ipc BLM 10 mg every 48 h). The drainage tube was removed when daily drainage was 20 ml or less. The primary end point was survival with MPE control (effusion failure-free survival, EFFS) at 2 months. Eighty patients were enrolled, and 79 were eligible. Effusion failure-free survival at 2 months was 29% in arm A and 46% in arm B (one-sided P=0.086 by Fisher's exact test). Arm B tended to favour EFFS, with a hazard ratio of 0.64 (95% confidence interval: 0.40–1.03, one-sided P=0.030 by log-rank test). No significant differences in the acute toxicities or complications were observed. The median survival was 79 days and 119 days in arm A and arm B, respectively. This medium-sized trial failed to show statistical significance in the primary end point. Although ipc BLM appeared safe and effective in the management of MPE, the therapeutic advantage seems modest

Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

Background Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown. Methods Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding. Results A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55). Conclusions Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218. opens in new tab.

Analysis of the surface topography of diffractive optical elements by white light interferometry

W artykule przedstawiono możliwości oceny i analizy topografii powierzchni dyfrakcyjnych elementów optycznych za pomocą jednej z metod interferometrii światła białego. W badaniach wykorzystano próbkę zawierającą 8 elementów dyfrakcyjnych generujących wzory optyczne o kształtach linii, zbioru linii (poziomych i pionowych) oraz krzyża. Elementy oceniano pod względem geometrii ukształtowania powierzchni za pomocą systemu pomiarowego Talysurf CCI 6000 firmy Taylor Hobson. Zarejestrowane dane pomiarowe analizowano korzystając z oprogramowania Talymap Platinum. Wyniki badań potwierdziły dużą przydatność metody pomiarowej, jak i zastosowanego urządzenia w ocenie tego typu powierzchni posiadających złożoną, wielowarstwową strukturę.The paper presents the method based on white light interferometry - SBI (Scanning Broadband Interferometry). SBI uses a correlation algorithm to find the coherence peak and phase position of an interference pattern produced by a selectable bandwidth light source. It provides both high resolution and excellent sensitivity of the returning light. This method can be applied to ultra precision assessment of wide range of surfaces. Measurements of different types of materials, including glass, metal, photo resist, polymer, liquid inks are also possible to be taken. In experimental investigations there was assessed the surface topography of DOEs (Diffractive Optical Elements). A sample containing 8 diffractive optical elements generating optical patterns in the form of single line, multi-lines and crosshair was used for measurements. The surfaces of the all DOEs were measured by an advanced measurement system Talysurf CCI 6000 produced by Taylor Hobson. The measurement data recorded were analysed by Talymap Platinum software. The investigation results confirmed the usefulness both of the measuring method and the applied measurement system for assessment of this type of multilayered surfaces

Application of the Hamming network to the classification of surfaces after abrasive machining

The use of artificial neural networks for modelling and inference about surface parameters is a more and more often undertaken research topic. Based on the analysis of the ranges of suitability of surface topography parameters, a variety of different parameters can be observed to identify surfaces with different features and different conditions of use. The issues of surface topography analysis and determination of surface condition after abrasive machining are of fundamental importance. Currently, when assessing the surface intended for interaction with the other surface, it is possible to use many surface evaluation parameters. Assigning the machined surface to the appropriate assessment group, especially in automated quality control systems, requires a preliminary surface classification. In this article Hamming's network was used for the surface classification along with modification of Hamming distance

Foundations of qualitative evaluation of the state of surfaces shaped with use of the theory of fuzzy sets

Zastosowanie teorii zbiorów rozmytych pozwala na jakościową ocenę powierzchni na podstawie parametrów struktury geometrycznej po-wierzchni (SGP). Zwiększa to komunikatywność oceny struktury geome-trycznej powierzchni, która nie jest opisana wyłącznie przez szereg często złożonych, wielu parametrów. W pracy przedstawiono ocenę cech stereometrycznych powierzchni na przykładzie parametrów amplitudowych SGP. Zastosowanie metod wnioskowania rozmytego umożliwiło modelowanie lingwistyczne ujmujące stopień wpływu poszczególnych parame-trów opisujących SGP na charakterystyczne cechy analizowanych powierzchni.The application of the theory of fuzzy sets lets on the qualitative evaluation of the surface on the basis of parameters of the geometrical structure of surface. Enlarges this the communicability of the evaluation of the structure of the geometrical surface which is not described exclusively by the series often confounding of many parameters. This paper is introduced to evaluation the guild of surface stereometry on the example of amplitude parameters. The using of fuzzy logic methods makes possible the creation of the linguistic model which contains influence of each parameters describing the surface stereometry on the correct classification

Measurement and analysis of residual stresses in Ti6Al5 using electronic speckle pattern interferometry (ESPI)

Naprężenia resztkowe wpływają między innymi na takie właściwości eksploatacyjne części maszyn, jak odkształcenie, wytrzymałość statyczna i dynamiczna, zużycie materiału, czy też wytrzymałość stykowa. Zastosowanie elektronicznej interferometrii plamkowej do pomiarów naprężeń resztkowych umożliwia wyeliminowanie problemów, które występują w standardowej metodzie tensometrycznej tj. pozycjonowanie wiertła względem rozety tensometrycznej, czy też zdeterminowana liczba kierunków pomiaru naprężeń. W pracy przedstawiono zagadnienia związane z pomiarami naprężeń resztkowych z zastosowaniem elektronicznej interferencji plamkowej (ESPI), stopu tytanu Ti6Al5 (TitanGrade 5) po obróbce ściernej, z zastosowaniem systemu Prism firmy Stresstech Oy.Residual stresses influence, among other parameters, on the performance characteristics of the machine, such as deformation, static and dynamic strength, material usage, or the strength of the contact. Extensional stresses as a result of abrasive machining reduce the fatigue strength for the dynamically loaded machine parts. It is preferred when the surface layer of the compressive stress is obtained. Therefore, it is recommended to reduce or remove most of the tensile stresses in the elements of the machine, for example, by reducing the value of technological parameters (feed-in). Note also that the type of occurring stresses depends also on the characteristics of the used grinding wheel, where the importance has the type of selected abrasive material. Grinding, eg. grinding wheel with aloxite grain is almost always the occurrence of tensile stresses, in contrast to CBN, which causes the formation of an compressive stresses in the surface layer. The article presents the issues related to the measurement of residual stresses by using electronic speckle pattern interference (ESPI), titanium alloy Ti6Al5 (TitanGrade 5), using a system of Stresstech Prism Oy. Stress measurements using ESPI can eliminate the problems that exist in the strain-gage method, such as the positioning of the axis of the drill in the center of the rosette hole, and only three directions of stress measurement (every 120 degrees). In the ESPI method stresses are recorded in all directions per-pendicular to the axis of the hole

Evaluation of the surface topography after precision machining

Analysis of the geometric features and determination of the condition of the surfaces machined during an abrasive process is of crucial importance for evaluation of their wear properties. Numerous parameters can be used for assessing topography of technical surfaces. Many of them contain information that is general or poorly correlated with the wear features. The group of parameters used for such purpose should include those that do not cause information redundancy and provide distinct information. Evaluation of the surface geometric structure after precision machining is a difficult process due to the limited scope of unevenness heights that fit within the range of a few micrometers to a few nanometers. In this paper the synthetic indexes of the evaluation of extra smooth surfaces were created, taking into consideration numerous elementary parameters. The value of the synthetic index was determined as the geometric average of the partial indexes which, when compared to the arithmetic average, is more dependent on the data believed to be disadvantageous

Application of the laser scanning microscopy to evaluation of abrasive tool wear

Grinding is one of the basic precise machining methods. Evaluation of the abrasive tool surface is the basic criterion of forecasting the tools' durability and the process results. The applied method of laser scanning made determination of the surface coordinates and subsequently of its geometric features with micrometric accuracy possible. Using the information on the abrasive tool surface geometric structure, a methodology of evaluation of the level of changes of the tool during the machining process was developed. The developed method allowed for evaluation of the level of abrasive tools' wear, and subsequently formed foundations for assessment of the influence of the machining parameters on the durability of abrasive tools, evaluation of the influence of the parameters of the process of shaping the abrasive tools' active surfaces on their geometric characteristic and evaluation of the level of correlation between the monitored process parameters and the degree of the abrasive tools' wear

Measurements of surface topography of microfinishing films with use of confocal laser scanning

W pracy przedstawiono zagadnienia związane z pomiarami topografii powie- rzchni narzędzi ściernych stosowanych w procesach mikro- i nanoobróbki. Ocenie poddano zestaw elastycznych foliowych taśm mikrościernych z ziarnem diamentowym o nominalnym wymiarze od 0,5 Μm do 30 Μm. W bada- niach wykorzystano zaawansowany laserowy mikroskop pomiarowy LEXT OLS4000 firmy Olympus. Analiza uzyskanych danych pomiarowych prowadzona była w dostarczonym przez producenta dedykowanym oprogramowaniu LEXT 5.0. Uzyskane rezultaty badań potwierdziły dużą użyteczność i szerokie możliwości pomiarowe wykorzystywanego mikroskopu w badaniach topografii powierzchni tego typu narzędzi ściernych.In modern industry it is often required to improve the cleanliness and finish quality of surfaces of precise manufacturing parts. For this purpose, producers apply microfinishing [1], which permits to obtain the better quality than that obtained by different conventional finishing processes. This influences significantly the maintenance of proper operating parameters by manufactured parts. Microfinishing process is realized by means of various types of abrasive tools such as microfinishing films [2]. Manufacturers often make available incomplete or incorrect technical data concerning the stereometric characteristics of produced abrasive tools. This situation complicates the proper selection of the optimal machining parameters. In this case it is necessary to conduct investigations of the surface topography of the microfinishing film with use of precise measuring methods. This paper proves that such investigations can be carried out with use of advanced microscopy methods such as nonlocal laser scanning microscopy (CLSM) [4]. During experimental investigations a set of IDLF (ImperialŽ Diamond Lapping Film) films produced by 3M was assessed. IDLF combine diamond grains (nominal diameter from 0.5 Μm to 30 Μm), a resin bonding system and a uniform polyester film. The measurement of films were taken by a 3D measuring laser microscope LEXT OLS4000 produced by Olympus (Fig. 1.). Analysis of the obtained data was carried out in the dedicated LEXT 5.0. software provided by a system producer. The obtained results of investigations (Fig. 2.) confirmed the high usefulness and wide range of measurement of the used microscope in assessment of the surface topography of these types of abrasive tools

Precyzyjne pomiary topografii powierzchni narzędzi ściernych z wykorzystaniem optycznego systemu profilometrycznego

This paper presents and discusses the proposed use of the Talysurf CLI 2000 system for performing high-accuracy measurements of the surface topography of abrasive tools. Specifically, the paper presents a brief description of the Talysurf CLI 2000 system (Fig. 1), as well as one of its modes of use, involving the chromatic aberration phenomenon. The selected results of the analysis of the measurement data obtained for the surface of a small-sized flat grinding wheel 1-20×20×10 SG 80 M 8 V (Fig. 2) and relevant visualizations pertaining to this analysis are given in the paper as well. All analyses of the measurement data were carried out using the TalyMap Silver software (Figs. 3-4). The obtained experiment results confirmed a high degree of usefulness of Talysurf CLI 2000 and the dedicated software (TalyMap Silver) for high-accuracy measurements of abrasive tools (grinding wheels). Therefore, the use of optical analysis methods may be an interesting alternative to the methods currently utilized in the assessment of abrasive tools.We współczesnym przemyśle wytwórczym dąży się do uzyskania bardzo wysokiej jakości wykończenia powierzchni. Na uzyskanie zakładanej jakości ma wypływ szereg czynników związanych m.in. ze stanem makro- i mikrogeometrii powierzchni narzędzia ściernego. Ocena i odpowiednia analiza stanu powierzchni ściernic ma więc w tym kontekście znaczenie podstawowe. Może być ona prowadzona za pomocą różnego rodzaju systemów pomiarowych, wykorzystujących wybrane metody stykowe oraz metody optyczne. W odniesieniu do ściernic precyzyjne pomiary stykowe i ich analiza mogą okazać się niewystarczające lub trudne do przeprowadzenia. W takim przypadku muszą być one zastąpione lub uzupełnione pomiarami optycznymi. Stwarza to pewne komplikacje wynikające m.in. z każdorazowej kalibracji urządzeń, wprowadzania innych parametrówpomiaru dla każdej z metod, oddzielnej analizy uzyskanych danych za pomocą różnych typów oprogramowania komputerowego. Wymienione działania znacząco wpływają na czas, dokładność i koszt przeprowadzenia pomiarów. Jedną z propozycji rozwiązania ww. problemów może być zastosowanie nowej klasy zintegrowanych systemów pomiarowych, oferujących możliwość oceny badanego przedmiotu za pomocą różnych technik pomiarowych dostępnych na jednej platformie sprzętowej. W pracy zaproponowano wykorzystanie optycznego systemu profilometrycznego Talysurf CLI 2000 firmy Taylor-Hobson Ltd. do precyzy-jnych pomiarów topografii powierzchni narzędzi ściernych. Dokonano krótkiej charakterystyki urządzenia oraz opisano jeden z trybów pomiarów wykorzystujący zjawisko abberacji chromatycznej. W części eksperymentalnej zaprezentowano wybrane wyniki analiz i wizualizacji danych pomiarowych uzyskanych dla powierzchni małogabarytowej ściernicy płaskiej o oznaczeniu technicznym 1-20×20×10 SG 80 M 8 V. Analizy przeprowadzono w oprogramowaniu TalyMap Silver. Uzyskane wyniki potwierdziły dużą użyteczność zastosowanego systemu Talysurf CLI 2000 oraz szerokie możliwości dedykowanego oprogramowania TalyMap Silver, co może stanowić ciekawą alternatywę dla wykorzystywanych już metod oceny stanu narzędzi ściernych (ściernic)