31 research outputs found

    Early objective response to avelumab treatment is associated with improved overall survival in patients with metastatic Merkel cell carcinoma

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    Background: Response rates are primary endpoints in many oncology trials; however, correlation with overall survival (OS) is not uniform across cancer types, treatments, or lines of therapy. This study explored the association between objective response (OR) and OS in patients with chemotherapy-refractory metastatic Merkel cell carcinoma who received avelumab (anti-PD-L1). Methods: Eighty-eight patients enrolled in JAVELIN Merkel 200 (part A; NCT02155647) received i.v. avelumab 10 mg/kg every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal. Using conditional landmark analyses, we compared OS in patients with and without confirmed OR (RECIST v1.1). We applied a Cox model that included OR as a time-varying covariate and adjusted for age, visceral disease, and number of previous therapies. Results: Twenty-nine patients had confirmed OR; 20 by study week 7 and 7 more between study weeks 7 and 13. Survival probabilities 18 months after treatment initiation were 90% [95% confidence interval (CI) 65.6-97.4] in patients with OR at week 7 and 26.2% (95% CI 15.7-37.8) in patients without OR but who were alive at week 7. Median OS was not reached in patients with OR and was 8.8 months (95% CI 6.4-12.9) in patients without. Similar results were observed for the week 13 landmark. The adjusted Cox model showed OR was associated with a 95% risk reduction of death [hazard ratio 0.052 (95% CI 0.018-0.152)] compared with a nonresponse. Conclusions: Patients with OR by 7 or 13 weeks had significantly longer OS than patients without, confirming that early OR is an endpoint of major importance

    Avaliação de revestimento de cromo por sputtering como alternativa à galvanização

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    A elevada resistência à corrosão dos revestimentos decorativos de cromo hexavalente obtidos nos processos de galvanoplastia é bem conhecida pela sua grande utilização e alta eficiência. Esse revestimento tem sido amplamente utilizado na indústria moveleira e de calçados, obtido por eletrodeposição em peças de zamac. No entanto, o processo galvânico apresenta alto grau poluidor devido à quantidade de efluentes geradas e à toxicidade dos produtos químicos utilizados no processo. Sabe-se que o cromo hexavalente é um agente cancerígeno e os resíduos associados são perigosos e difíceis de serem tratados. Neste contexto, o desenvolvimento de novas tecnologias tem visado à obtenção de processos resistentes à corrosão, ambientalmente corretos e economicamente viáveis. A tecnologia alternativa que pode ir ao encontro desta necessidade é o PVD - physical vapor deposition, com o processo de sputtering. Neste sentido, este estudo tem como objetivo avaliar e comparar o desempenho de revestimentos de cromo aplicados por sputtering com verniz em relação ao desempenho do revestimento de cromo eletrodepositado. Para tanto, os revestimentos foram aplicados em zamac e foram caracterizados morfologicamente, eletroquimicamente e físico-quimicamente. Os resultados mostraram que os acabamentos de cromo depositados por sputtering apresentam características equivalentes quanto ao desempenho eletroquímico se comparados ao revestimento cromado no processo convencional, podendo ser uma alternativa de substituição com âmbito sustentável. Palavras-chave: galvanização, sputtering, cromo, resistência a corrosã

    Einsatz von Formgedächtnismaterialien in minimalinvasiven chirurgischen Instrumenten

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    Die verabschiedete neue europäische Medizinprodukte-Verordnung (MDR), ihre Auswirkungen auf nationale Gesetze sowie regulatorische Herausforderungen für nicht-ärztliche Leistungserbringer spielen eine ebenso große Rolle wie das in Kraft getretene Heil- und Hilfsmittelversorgungsgesetz (HHVG) und damit bevorstehende Aufgaben für Krankenkassen, Leistungserbringer und weitere am Versorgungsprozess Beteiligte. Im Blickpunkt stehen zudem die Wirtschaftsbeziehungen Deutschlands zu drei der wichtigsten Handelspartner der deutschen MedTech-Industrie: USA, China und Indien

    Medizinische Vorrichtung zum Durchführen einer Biopsie und Verfahren zum Herstellen der medizinischen Vorrichtung

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    Die vorliegende Erfindung betrifft eine medizinische Vorrichtung zum Durchführen einer Biopsie an einem Bereich (2) eines zu untersuchenden Körpers (8) und ein Verfahren zum Herstellen der medizinischen Vorrichtung. Die medizinische Vorrichtung weist mindestens drei Anschlusselementen (1) zum Anbringen der Vorrichtung an dem Bereich (2) des Körpers (8) oder zum Anbringen der Vorrichtung an Verankerungselemente, die an dem Bereich (2) des Körpers (8) angeordnet sind, eine Hülse (3) als Führung für ein medizinisches Instrument (6), und ein Verbindungselement (4) auf, durch das die mindestens drei Verankerungselemente (1) mit der Hülse (3) verbunden sind. Zumindest das Verbindungselement (4) ist aus einem Leichtbauwerkstoff ausgebildet

    Biocompatibility and Inflammatory Potential of Titanium Alloys Cultivated with Human Osteoblasts, Fibroblasts and Macrophages

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    The biomaterials used to maintain or replace functions in the human body consist mainly of metals, ceramics or polymers. In orthopedic surgery, metallic materials, especially titanium and its alloys, are the most common, due to their excellent mechanical properties, corrosion resistance, and biocompatibility. Aside from the established Ti6Al4V alloy, shape memory materials such as nickel-titanium (NiTi) have risen in importance, but are also discussed because of the adverse effects of nickel ions. These might be reduced by specific surface modifications. In the present in vitro study, the osteoblastic cell line MG-63 as well as primary human osteoblasts, fibroblasts, and macrophages were cultured on titanium alloys (forged Ti6Al4V, additive manufactured Ti6Al4V, NiTi, and Diamond-Like-Carbon (DLC)-coated NiTi) to verify their specific biocompatibility and inflammatory potential. Additive manufactured Ti6Al4V and NiTi revealed the highest levels of metabolic cell activity. DLC-coated NiTi appeared as a suitable surface for cell growth, showing the highest collagen production. None of the implant materials caused a strong inflammatory response. In general, no distinct cell-specific response could be observed for the materials and surface coating used. In summary, all tested titanium alloys seem to be biologically appropriate for application in orthopedic surgery

    Influence of a Modified Procedure of Joining Ceramic Head and Adapter Sleeve on the Stem Taper in Revision: An Experimental Study

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    In revision operations, ceramic heads of modular hip implants can be replaced. As the surface of the stem taper can be damaged, additional adapter sleeves are applied. The components are usually connected manually by the surgeon in a one-step procedure by hammer impacts. In this study, we investigated a two-step joining procedure with reproducible impaction force. First, the adapter sleeve and head were joined quasi-statically with a force of 2 kN using an assembly device. In the second step, these components were applied to the stem taper using a pulse-controlled instrument. For reference, the joints were assembled according to standard conditions using a tensile testing machine. An average pull-off force of 1309 ± 201 N was achieved for the components joined by the instrument, and the average measured values for the components joined by the testing machine were 1290 ± 140 N. All specimens achieved a force >350 N when released and therefore met the acceptance criterion defined for this study. This study showed that a modified procedure in two steps with a defined force has a positive effect on the reproducibility of the measured joining forces compared to previous studies

    Position Control and Force Estimation Method for Surgical Forceps Using SMA Actuators and Sensors

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    Minimally invasive surgery is increasingly used in many medical operations because of the benefits for the patients. However, for the surgeons, accessing the situs through a small incision or natural orifice comes with a reduction of the degrees of freedom of the instrument. Due to friction of the mechanical coupling, the haptic feedback lacks sensitivity that could lead to damage of the tissue. The approach of this work to overcome these problems is to develop a control concept for position control and force estimation with shape memory alloys (SMA) which could offer haptic feedback in a novel handheld instrument. The concept aims to bridge the gap between manually actuated laparoscopic instruments and surgical robots. Nickel-titanium shape memory alloys are used for actuation because of their high specific energy density. The work includes the manufacturing of a functional model as a proof of concept comprising the development of a suitable forceps mechanism and electronic circuit for position control and gripping force measurement, as well as designing an ergonomic user interface with haptic force feedback
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