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Osnabrück, Germany

van Ahlen H.,Klinikum Osnabruck | Zumbe J.,Klinikum Leverkusen | Stauch K.,Bayer Vital GmbH | Hanisch J.U.,Bayer Vital GmbH
Journal of Sexual Medicine | Year: 2010

Introduction: The Real-Life Safety and Efficacy of vardenafil study is an international, open-label, prospective, noncomparative, noninterventional study in men with erectile dysfunction (ED). Aim: To determine the safety and efficacy of vardenafil in a large international pool of men with ED (aged ≥18 years) and associated underlying conditions (N = 73,946), in a real-life setting. Methods: Patients attended an initial physician visit and one to two follow-up visits. Data were acquired by physician interviews and patient diaries and recorded in case report forms (CRFs). Data were pooled from 47 countries in Europe, Asia-Pacific, Latin America, and the rest of the world (excluding the United States and Japan for methodological reasons). Results were stratified by baseline ED severity, body mass index (BMI), and the presence of hypertension, diabetes, lipid metabolism disorder, or cardiovascular disease (CVD). Main Outcome Measures: CRFs and patient questionnaires containing questions on overall improvement of erection, satisfaction with efficacy, and desire to continue vardenafil use. Results: Many participants had hypertension (32.0%), diabetes (22.1%), lipid metabolism disorder (14.6%), or CVD (42.2%). High percentages of patients reported improvements in erectile function, irrespective of baseline ED severity (mild, 97.0%; moderate, 96.2%; severe, 85.5%), BMI (<25, 94.1%; ≥25 and <30, 94.6%; ≥30, 92.9%), or the presence of hypertension (93.6%), diabetes (92.6%), lipid metabolism disorder (94.7%), or CVD (93.3%). Over 90% of patients, including those with underlying conditions, reported being " satisfied" or " very satisfied" with vardenafil efficacy, and stated their intention to continue vardenafil use after the end of the study period. The incidence of adverse events was low, and 97.0% of patients were either " satisfied" or " very satisfied" with vardenafil tolerability. Conclusions: These data from a worldwide population of men with ED and associated underlying conditions show that vardenafil is effective and well-tolerated for the treatment of ED in a real-life setting, supporting its use as a first-line ED therapy. © 2010 International Society for Sexual Medicine.

Lanfer B.,University of Munster | Roer C.,University of Munster | Scherg M.,BESA GmbH | Rampp S.,Friedrich - Alexander - University, Erlangen - Nuremberg | And 2 more authors.
Brain Topography | Year: 2013

The simultaneous evaluation of the local electrocorticogram (ECoG) and the more broadly distributed electroencephalogram (EEG) from humans undergoing evaluation for epilepsy surgery has been shown to further the understanding of how pathologies give rise to spontaneous seizures. However, a well-known problem is that the disruption of the conducting properties of the brain coverings can render simultaneous scalp and intracranial recordings unrepresentative of the habitual EEG. The ECoG electrodes for measuring the potential on the surface of the cortex are commonly embedded into one or more sheets of a silastic material. These highly resistive silastic sheets influence the volume conduction and might therefore also influence the scalp EEG and ECoG measurements. We carried out a computer simulation study to examine how the scalp EEG and the ECoG, as well as the source reconstruction therefrom, employing equivalent current dipole estimation methods, are affected by the insulating ECoG grids. The finite element method with high quality tetrahedral meshes, generated using a constrained Delaunay tetrahedralization meshing approach, was used to model the volume conductor that incorporates the very thin ECoG sheets. It is shown that the insulating silastic substrate of the ECoG grids can have a large impact on the scalp potential and on source reconstruction from scalp EEG data measured in the presence of the grids. The reconstruction errors are characterized with regard to the location of the source in the brain and the mislocalization tendency. In addition, we found a non-negligible influence of the insulating grids on ECoG based source analysis. We conclude, that the thin insulating ECoG sheets should be taken into account, when performing source analysis of simultaneously measured ECoG and scalp EEG data. © 2012 Springer Science+Business Media, LLC.

Reuter I.,Justus Liebig University | Mehnert S.,Justus Liebig University | Sammer G.,Justus Liebig University | Oechsner M.,HELIOS Klinik Zihlschlacht AG | Engelhardt M.,Klinikum Osnabruck
Journal of Aging Research | Year: 2012

Mild cognitive impairment, especially executive dysfunction might occur early in the course of Parkinson's disease. Cognitive training is thought to improve cognitive performance. However, transfer of improvements achieved in paper and pencil tests into daily life has been difficult. The aim of the current study was to investigate whether a multimodal cognitive rehabilitation programme including physical exercises might be more successful than cognitive training programmes without motor training. 240 PD-patients were included in the study and randomly allocated to three treatment arms, group A cognitive training, group B cognitive training and transfer training and group C cognitive training, transfer training and psychomotor and endurance training. The primary outcome measure was the ADAS-Cog. The secondary outcome measure was the SCOPA-Cog. Training was conducted for 4 weeks on a rehabilitation unit, followed by 6 months training at home. Caregivers received an education programme. The combination of cognitive training using paper and pencil and the computer, transfer training and physical training seems to have the greatest effect on cognitive function. Thus, patients of group C showed the greatest improvement on the ADAS-Cog and SCOPA-COG and were more likely to continue with the training programme after the study. © 2012 I. Reuter et al.

Lorbach O.,Klinikum Osnabruck | Lorbach O.,Saarland University | Anagnostakos K.,Saarland University | Scherf C.,Saarland University | And 3 more authors.
Journal of Shoulder and Elbow Surgery | Year: 2010

Hypothesis: Oral and intra-articular injections of cortisone will lead to significant improvement and comparable results in the treatment of adhesive capsulitis of the shoulder. Materials and methods: In a prospective randomized evaluation, 40 patients with idiopathic adhesive capsulitis of the shoulder were treated with an oral corticoid treatment regimen or 3 intra-articular injections of corticosteroids. Follow-up was after 4, 8, and 12 weeks, and 6 and 12 months. For the clinical evaluation, the Constant-Murley (CM) score, the Simple Shoulder Test (SST) and visual analog scales (VAS) for pain, function, and satisfaction were used. Results: In the patients treated with oral glucocorticoids, significant improvements were found for the CM score (P < .0001), SST (P=.035), VAS (P < .0001), and range of motion (P < .05) at the 4-week follow-up. The patients treated with an intra-articular glucocorticoid injection series also significantly improved in the CM score (P < .0001), SST (P < .0001), the VAS (P < .0001), and range of motion (P < .05) after 4 weeks. These results were confirmed at all other follow-up visits. Superior results were found for intra-articular injections in range of motion, CM score, SST, and patient satisfaction (P < .05). Differences in the VAS for pain and function were not significant (P > .05). Discussion: The use of cortisone in the treatment of idiopathic shoulder adhesive capsulitis leads to fast pain relief and improves range of motion. Intra-articular injections of glucocorticoids showed superior results in objective shoulder scores, range of motion, and patient satisfaction compared with a short course of oral corticosteroids. © 2010 Journal of Shoulder and Elbow Surgery Board of Trustees.

BACKGROUND: The influence of the anteromedial and posterolateral bundles of the anterior cruciate ligament on tibiofemoral rotation might be of great value to detect anterior cruciate ligament injuries and investigate the postoperative restoration of rotational stability. HYPOTHESIS: The anterior cruciate ligament and especially the posterolateral bundle will have a significant influence on isolated tibiofemoral rotation. STUDY DESIGN: Controlled laboratory study. METHODS: Tibiofemoral rotation was measured in 20 human cadaveric knees using a noninvasive external measurement device (Rotameter) and a knee navigation system. The measurements of the knees with the intact anterior cruciate ligament were compared with the measurements after isolated resection of the posterolateral bundle and after a complete resection of the anterior cruciate ligament at an applied torque of 5,10, and 15 N.m. Statistical analysis was made using analysis of variance and the post hoc Scheffé test. The Pearson coefficient was used to compare both measurement techniques. RESULTS: In comparison with knees with an intact anterior cruciate ligament, the knees after isolated resection of the posterolateral bundle showed significant increase of tibiofemoral rotation at almost all applied torques (P <.05). Total resection of the anterior cruciate ligament also produced significant increases compared with the intact anterior cruciate ligament at torques of 5, 10, and 15 N.m as measured by the Rotameter (P <.05). Total resection of the anterior cruciate ligament yielded increases in rotation compared with posterolateral bundle resection alone, but these differences were not significant. The results of the knee navigation system confirmed the measured results of the Rotameter. Comparison of the 2 measurement methods revealed a high correlation at all applied torques, with Pearson correlation coefficients ranging from .85 to .95. CONCLUSION: The anterior cruciate ligament and especially the posterolateral bundle of the anterior cruciate ligament have a significant effect on isolated tibiofemoral rotation. Therefore, the developed noninvasive device might be of great importance to investigate the status and the postoperative reconstruction of the anterior cruciate ligament in the clinical setting. CLINICAL RELEVANCE: Noninvasive measurement of tibiofemoral rotation might be useful to detect anterior cruciate ligament tears and to evaluate the restoration of rotational stability after anterior cruciate ligament surgery.

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