Hameln (Slovakia)

The development of spatial perspective-taking has been described in a two-level model. Inconsistent research results led to more differentiated three-level models. This study draws upon these ideas and aims at developing and validating an integrated three-level model by choosing two approaches. First, prior research results will be interpreted by using the three-level model. Second, we reanalyze data from an interview study with 95 first graders. In particular, the children’s explanations for their solutions showed that level-3-tasks were more difficult for them than level-2-tasks.Our findings suggest that a three-level model is appropriate to describe the development of spatial perspective-taking more precisely.

Strains of methicillin-resistant Staphylococcus aureus (MRSA) are of major economic and health-related importance to early neurological and neurosurgical rehabilitation. It is crucial to identify MRSA-carriers as soon as possible upon admission in order to prevent transmissions and to initiate contact precautions and decolonization. The present study focuses on validity of a polymerase chain reaction (PCR) test to identify MRSA genetic material from nasopharyngeal samples (BD MAX MRSA XT, BD Diagnostics, Heidelberg, Germany) of early neurological and neurosurgical rehabilitation patients. PCR-results were compared to gold standard (culture). In 2013, 66 patients were tested using PCR and incubation within one week after admission. Sensitivity of PCR was 84.6 %, specificity 86.6 %. Positive predictive value (PPV) was only 61.1 %, while negative predictive value was as high as 95.8 %. In 39 cases, PCR and subsequent culture were done within one day, leading to a sensitivity of 100 % and a specificity of 90.3 %. In this subgroup, PPV was 72.7 %, NPV 100 %. The results from the study suggest that incubation should quickly follow a positive PCR finding (within 24hours) in order to verify MRSA colonization. High NPV (95.8 resp. 100 %) indicate that PCR negative patients very likely are not colonized with MRSA. A positive PCR test is less reliable (due to false positive results) and should be followed by incubation in due course in order to avoid unnecessary contact precautions.

During the years of the Nazi regime, Paul Hindemith’s opera Mathis der Maler was regarded as the epitome of the aesthetic resistance movement against the regime, to quote Hans Heinz Stuckenschmidt. Performances were not allowed in Germany in spite of the plot being viewed as “German enough” in nature. The press reactions following the first performance 1938 in Zurich or the first German performance 1946 in Stuttgart show that this “Germanness” was instrumentalized for both the sake of the resistance and for assimilation to the Nazi regime, even though Hindemith’s strategies of a verdeckte Schreibweise (writing between the lines; see Dolf Sternberger) were not even recognized.

On occasion of the Munich Plastic Symposium in Munich the board of the Deutsche Gesellschaft der Plastischen, Rekonstruktiven und Ästhetischen Chirurgen (DGPRÄC) together with a group of experts who were also involved in the preparation of the recently published S2K guideline "Autologous Fat Grafting", prepared a consensus statement from a plastic-surgical point of view so to evaluate current spects and taking into account the current legal framework: 1. Autologous Fat Grafting is a long established treatment in plastic surgery and does not differ from other tissue grafts. 2. Mechanical processing of autologous fat does not provide any substantial change tot he tissue. 3. If other treatment methods to enrich progenitor cells of autolous fat i. e. by an enzymatic process have evidence that autologous adipose tissue or cells were substantially changed, classification as a drug could come in question under current german law (application of AMG/ATMP).

The aim of this work was to evaluate the effects of incorporating thrombin in arabinogalactan (AG)/β-glucan (BG)-based carriers. The products were characterized by Fourier transform infrared spectroscopy, scanning electron microscopy, X-ray powder diffraction (XRPD) and X-ray photoelectron spectroscopy techniques. Results, especially deconvoluted XRPD patterns indicated creation of new phases and potential complex formation. Results also highlighted that the AG carrier leads to higher residual thrombin-specific activity, while the in vivo haemostatic effect was enhanced when insoluble BG was present in the matrix. Our results confirm that thrombin can be successfully added to the carriers and that these materials are promising alternatives to standard vehicles.

Abstract Two reversed-phase high performance liquid chromatography analytical methods (Method I and Method II) for determination of assay of recombinant human thrombin in pharmaceutical formulations were developed and validated. Analysis was performed on chromatographic system Agilent 1200 series SL with diode array detection and mass selective detection. Method I was intended for faster determination of thrombin assay. Gradient programme was optimised to achieve sufficient separation and acceptable runtime. Chromatographic analysis was performed on analytical column Grace Vydac, C4 250 × 4.6 mm, 5 mm. Method II is Method I adapted to use the mass selective detector. Chromatographic separation was performed on analytical column Zorbax 300SB-C8 SolvSaver Plus, 150 × 3 mm, 3.5 mm. Both analytical methods were validated with respect to specificity, linearity, precision and accuracy. The response of thrombin was a linear function of concentration over the range 0.1-1.0 mg/ml. Precision and accuracy of thrombin was evaluated at three concentration levels low (0.2 mg/ml), medium (0.4 mg/ml) and high (0.8 mg/ml). Both validated methods have been successfully applied for determination of assay and thrombin degradation products in pharmaceutical formulations.

Recombinant human thrombin (rhThrombin) is a potential hemostatic alternative to bovine and human plasma-derived thrombin. Hemostatic, liver regeneration effect and plasma concentrations of rhThrombin (SCILL) tested in the form of solution and hydrogels (thermo-sensitive poloxamer gel and carbomer gel; hameln rds) were evaluated.In the bleeding model, rhThrombin was applied locally on the bleeding site. The time to hemostasis was measured. The rhThrombin in liquid form as well as the thermo-sensitive gel forming formulation significantly reduced the bleeding time in comparison to saline. In the regeneration model, a cut in the form “V” was made on the liver and rhThrombin in both formulations was applied at defined concentrations to the wound for 5 min. The rats survived 1, 3 and 5 days after the injury and treatment. Histological examination showed better results in the group treated with rh Thrombin gel in comparison to the liquid form – solution; differences were insignificant.Low [125I]-rhThrombin radioactivity was evaluated in plasma after topical application (solution and both hydrogels) at hemostatic effective doses to partial hepatectomy in rats. Locally applied rh Thrombin on the rat damaged liver tissue never reached pharmacologically active systemic levels. The plasmatic levels and the content of this active protein in injured liver tissue were lower after application of its hydrogels versus solution.

Magnetic fluids used in biomedicine have to be biocompatible and therefore the magnetic nanoparticles are modified by different biocompatible materials. In this work the magnetic nanoparticles Fe3O4 sterically stabilized by sodium oleate were prepared by coprecipitation method. Consequently they were modified with polyethylene glycol (PEG) of different molecular weights and different PEG to magnetite Fe3O4 feed weight ratios varying from 0.01 to 30 to produce biocompatible magnetic fluids (MFPEG). The morphology was observed by scanning electron microscopy. The magnetic nanoparticles coated with PEG showed almost spherical shape for all studied systems of MFPEG. Differential scanning calorimetry (DSC) was used to study the adsorption of PEG on magnetic nanoparticles and to determine the maximal amount of PEG adsorbed on the magnetic nanoparticles. The increasing PEG molecular weight leads to the decrease in maximal PEG/Fe3O4 feed weight ratio. In vitro toxicity of the magnetic fluids using cells of skin cancer of mice B16 was tested with the aim to confirm the biocompatibility of the prepared magnetic fluids.

Abstract Strategy, Management and Health Policy Enabling Technology, Genomics, Proteomics Preclinical Research Preclinical Development Toxicology, Formulation Drug Delivery, Pharmacokinetics Clinical Development Phases I‐III Regulatory, Quality, Manufacturing Postmarketing Phase IV Medical countermeasure drug development is a complex field that is an important component of public and private medical preparedness. Medical professionals and emergency management planners in military, government, and private settings depend on successful drug development and collaboration among project sponsors, research institution(s), and private pharmaceutical companies. When a medical countermeasure is developed, manufacturing, distribution security, logistics, training, and protocol needs are arranged within a complex economic and political reality. The medical countermeasure products that are developed sit waiting with hope that they are never used. When they are needed, rapid access and well‐developed preparedness plans are critical for the important emergency response that is expected in the aftermath of a disaster. Preparedness plans and procedures are continually changing, and medical countermeasure practices need to change and develop further to keep pace with evolving risk. Partnerships among government, research, and the private sector can help guarantee successful drug development toward improved emergency preparedness. These elements, when combined with well‐developed preparedness plans, can help ensure the rapid availability of important medications needed to treat victims following a terrorist event or other disaster.