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Nürnberg, Germany

Lebert C.,Klinikum Nurnberg Sud | Scherbel G.,Klinikum Nurnberg Sud | Hohl R.,Klinikum Nurnberg Nord
Arzneimitteltherapie | Year: 2010

During the last years several new antifungal agents as anidulafungin and micafungin have become available and several new studies have been published relating to the treatment of candidemia and other forms of invasive candidiasis. These new pieces of information were incorporated into the revised guidelines of the Infectious Diseases Society of America (IDSA) for the management of candidiasis. The intention of this article is to give an overview of essential recommendations under special consideration of the German approval and the possibility of using antifungal agents in pediatric patients. Source


Brucker C.,Klinikum Nurnberg Nord | Hedon B.,Hopital Arnaud de Villeneuve | The H.S.,St Antonius Ziekenhuis | Hoschen K.,Grunenthal GmbH | And 2 more authors.
Contraception | Year: 2010

Objective: This study was conducted to assess the long-term efficacy and safety of a low-dose monophasic combined oral contraceptive (COC) containing 0.02 mg ethinylestradiol (EE) and 2 mg chlormadinone acetate (CMA) in a novel regimen administered daily for 24 days followed by a 4-day placebo interval. Study Design: In this multicenter, uncontrolled, Phase III trial, 1665 subjects took the COC 0.02 mg EE/2 mg CMA for up to 21 cycles. The overall Pearl Index was the primary end point; cycle control, safety, effect on acne and seborrhea, and changes in body weight and libido were secondary end points. Results: Contraceptive efficacy was analyzed for 1653 subjects completing 21,495 cycles. Six pregnancies occurred during trial duration with one attributable to method failure. The overall Pearl Index for the first year of use was 0.33 (95% confidence interval, 0.09-0.85). The mean number of bleeding/spotting days during six 90-day reference periods (RPs) decreased from 17.0 (RP 1) to 11.7 (RP 6), and the number of bleeding episodes per RP decreased from 3.8 (RP 1) to 2.7 (RP 6). Among subjects who presented with acne at the baseline visit, a decrease of papules/pustules and comedones was observed during the course of the trial. The most common "at least possibly related" adverse events were headache, breast discomfort and nausea. The tolerability and well-being was reported as being excellent or good in the majority of trial subjects (84.6% and 80.2%, respectively). Conclusions: The low-dose COC 0.02 mg EE/2 mg CMA administered daily for 24 days followed by a 4-day placebo interval provides high contraceptive efficacy combined with an adequate cycle control and safety profile, beneficial effects on acne, and is well tolerated. © 2010 Elsevier Inc. All rights reserved. Source


Coiffier B.,Hospices Civils de Lyon | Pro B.,Thomas Jefferson University | Prince H.M.,University of Melbourne | Foss F.,Yale Cancer Center | And 13 more authors.
Journal of Hematology and Oncology | Year: 2014

Background: Romidepsin is a structurally unique, potent, bicyclic class 1 selective histone deacetylase inhibitor approved by the US Food and Drug Administration for the treatment of patients with cutaneous T-cell lymphoma who have received ≥ 1 prior systemic therapy and patients with peripheral T-cell lymphoma (PTCL) who have received ≥ 1 prior therapy. Approval for PTCL was based on results (n = 130; median follow-up, 13.4 months) from the pivotal study of romidepsin for the treatment of relapsed/refractory PTCL. The objective is to present updated data (median follow-up, 22.3 months) and to characterize patients who achieved long-term responses (≥ 12 months) to romidepsin. Methods. Patients with PTCL who relapsed from or were refractory to ≥ 1 prior systemic therapy received romidepsin 14 mg/m§ssup§2§esup§ as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days for up to 6 cycles; patients with response or stable disease could continue romidepsin beyond 6 cycles. The primary endpoint was rate of confirmed/unconfirmed complete response (CR/CRu) determined by an Independent Review Committee. Secondary endpoints included objective response rate (ORR) and duration of response (DOR). For patients who achieved CR/CRu, baseline characteristics by DOR (≥ 12 vs < 12 months) were examined. Results: The ORR to romidepsin was 25%, including 15% with CR/CRu. The median DOR for all responders was 28 months (range, < 1-48+) and was not reached for those who achieved CR/CRu. Patients with lack of response or transient response to prior therapy achieved durable responses with romidepsin. Of the 19 patients who achieved CR/CRu, 10 had long-term (≥ 12 months) responses; none of the baseline characteristics examined - including heavy pretreatment, response to prior therapy, or advanced disease - precluded long-term responses to romidepsin. With a median progression-free survival of 29 months, patients who achieved CR/CRu for ≥ 12 months had significantly longer survival vs those with CR/CRu for < 12 months or < CR/CRu. Extended treatment and longer follow-up did not affect the reported safety profile of romidepsin. Conclusions: Treatment with romidepsin leads to highly durable responses in a subset of patients with relapsed/refractory PTCL, with responses ongoing as long as 48 months. Trial registration. NCT00426764. © 2014 Coiffier et al.; licensee BioMed Central Ltd. Source


Fielding R.A.,U.S. Department of Agriculture | Vellas B.,Toulouse University Hospital Center | Evans W.J.,Glaxosmithkline | Bhasin S.,Boston University | And 20 more authors.
Journal of the American Medical Directors Association | Year: 2011

Sarcopenia, the age-associated loss of skeletal muscle mass and function, has considerable societal consequences for the development of frailty, disability, and health care planning. A group of geriatricians and scientists from academia and industry met in Rome, Italy, on November 18, 2009, to arrive at a consensus definition of sarcopenia. The current consensus definition was approved unanimously by the meeting participants and is as follows: Sarcopenia is defined as the age-associated loss of skeletal muscle mass and function. The causes of sarcopenia are multifactorial and can include disuse, altered endocrine function, chronic diseases, inflammation, insulin resistance, and nutritional deficiencies. Although cachexia may be a component of sarcopenia, the 2 conditions are not the same. The diagnosis of sarcopenia should be considered in all older patients who present with observed declines in physical function, strength, or overall health. Sarcopenia should specifically be considered in patients who are bedridden, cannot independently rise from a chair, or who have a measured gait speed less that 1 m/s-1. Patients who meet these criteria should further undergo body composition assessment using dual energy x-ray absorptiometry with sarcopenia being defined using currently validated definitions. A diagnosis of sarcopenia is consistent with a gait speed of less than 1 m·s-1 and an objectively measured low muscle mass (eg, appendicular mass relative to ht2 that is ≤ 7.23 kg/m2 in men and ≤ 5.67 kg/m2 in women). Sarcopenia is a highly prevalent condition in older persons that leads to disability, hospitalization, and death. © 2011 American Medical Directors Association. Source


Evangelatos N.,Klinikum Nurnberg Nord | Carayannis E.,George Washington University
International Journal of Social Ecology and Sustainable Development | Year: 2014

The phenomenon of diffusion has been extensively studied from different disciplines in the natural and social sciences and has been used in the study of innovation dynamics. Diffusion plays also a central role to the study of disease-spread within a population, being an essential element of epidemiological research. In case of disease-diffusion, the contagious agents spread among susceptible individuals, thus rendering them infected. Those individuals can in turn communicate the disease to other susceptible community members and start an epidemic. These characteristics of disease-spread have been successfully studied by epidemiological theoretical tools. Patent citations, traditionally used as indicators for R&D output, signal the acquisition of knowledge and, in that sense, facilitate diffusion of innovation. In this paper the authors argue that patent citations could be seen as contagious agents and the diffusion of innovation could be studied with tools from the field of epidemiology. In this direction the authors draw a theoretical framework for future original research. Copyright © 2014, IGI Global. Source

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