Falcon Takes Off - A Hardware Implementation of the Falcon Signature Scheme

Falcon is one out of three post-quantum signature schemes which have been selected for standardization by NIST in July 2022. To the best of our knowledge, Falcon is the only selected algorithm that does not yet have a publicly reported hardware description that performs signing or key generation. The reason might be that the Falcon signature and key generation algorithms do not fit well in hardware due to the use of floating-point numbers and recursive functions. This publication describes the first hardware implementation for Falcon signing and key generation. To overcome the complexity of the Falcon algorithms, High-Level Synthesis (HLS) was preferred over a hardware description language like Verilog or VHDL. Our HLS code is based on the C reference implementation available at NIST. We describe the required modifications in order to be compliant with HLS, such as rewriting recursive functions into iterative versions. The hardware core at security level 5 requires 45,223 LUTs, 41,370 FFs, 182 DSPs, and 37 BRAMs to calculate one signature in 8.7 ms on a Zynq UltraScale+ FPGA. Security level 5 key generation takes 320.3 ms and requires 100,649 LUTs, 91,029 FFs, 1,215 DSPs, and 69 BRAMs

Immune Modulation to Enhance Bone Healing -A New Concept to Induce Bone Using Prostacyclin to Locally Modulate Immunity

Within an aging population, fracture incidences will rise and with the augmented risks of impaired healing the overall risk of delayed bone regeneration will substantially increase in elderly patients. Thus, new strategies to rescue fracture healing in the elderly are highly warranted. Modulating the initial inflammatory phase toward a reduced pro-inflammation launches new treatment options for delayed or impaired healing specifically in the elderly. Here, we evaluated the capacity of the prostacyclin analog Iloprost to modulate the inflammatory phase toward a pro-regenerative milieu using in vitro as well as in vivo model systems. In vitro, Iloprost administration led to a downregulation of potential unfavorable CD8+ cytotoxic T cells as well as their pro-inflammatory cytokine secretion profile. Furthermore, Iloprost increased the mineralization capacity of osteogenic induced mesenchymal stromal cells through both direct as well as indirect cues. In an in vivo approach, Iloprost, embedded in a biphasic fibrin scaffold, decreased the pro-inflammatory and simultaneously enhanced the anti-inflammatory phase thereby improving bone healing outcome. Overall, our presented data confirms a possible strategy to modulate the early inflammatory phase in aged individuals toward a physiological healing by a downregulation of an excessive pro-inflammation that otherwise would impair healing. Further confirmation in phase I/II trials, however, is needed to validate the concept in a broader clinical evaluation

Towards a Generally Accepted Validation Methodology for Sensor Models - Challenges, Metrics, and First Results

In order to significantly reduce the testing effort of autonomous vehicles, simulation-based testing in combination with a scenario-based approach is a major part of the overall test concept. But, for sophisticated simulations, all applied models have to be validated beforehand, which is the focus of this paper. The presented validation methodology for sensor system simulation is based on a state-of-the-art analysis and the derived necessary improvements. The lack of experience in formulating requirements and providing adequate metrics for their usage in sensor model validation, in contrast to e.g. vehicle dynamics simulation, is addressed. Additionally, the importance of valid measurement and reference data is pointed out and especially the challenges of repeatability and reproducibility of trajectories and measurements of perception sensors in dynamic multi-object scenarios are shown. The process to find relevant scenarios and the resulting parameter space to be examined is described. At the example of lidar point clouds, the derivation of metrics with respect to the requirements is explained and exemplary evaluation results are summarized. Based on this, extensions to the state-of-the-art model validation method are provided

Data and Safety Monitoring Boards: Some Enduring Questions

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/75571/1/j.1748-720X.2009.00410.x.pd

Non-beneficial pediatric research : individual and social interests

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects

Immune Modulation to Enhance Bone Healing—A New Concept to Induce Bone Using Prostacyclin to Locally Modulate Immunity

Within an aging population, fracture incidences will rise and with the augmented risks of impaired healing the overall risk of delayed bone regeneration will substantially increase in elderly patients. Thus, new strategies to rescue fracture healing in the elderly are highly warranted. Modulating the initial inflammatory phase toward a reduced pro-inflammation launches new treatment options for delayed or impaired healing specifically in the elderly. Here, we evaluated the capacity of the prostacyclin analog Iloprost to modulate the inflammatory phase toward a pro-regenerative milieu using in vitro as well as in vivo model systems. In vitro, Iloprost administration led to a downregulation of potential unfavorable CD8+ cytotoxic T cells as well as their pro-inflammatory cytokine secretion profile. Furthermore, Iloprost increased the mineralization capacity of osteogenic induced mesenchymal stromal cells through both direct as well as indirect cues. In an in vivo approach, Iloprost, embedded in a biphasic fibrin scaffold, decreased the pro-inflammatory and simultaneously enhanced the anti-inflammatory phase thereby improving bone healing outcome. Overall, our presented data confirms a possible strategy to modulate the early inflammatory phase in aged individuals toward a physiological healing by a downregulation of an excessive pro-inflammation that otherwise would impair healing. Further confirmation in phase I/II trials, however, is needed to validate the concept in a broader clinical evaluation

Long-Term Outcomes After Transcatheter Aortic Valve Implantation in High-Risk Patients With Severe Aortic Stenosis The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry

ObjectivesThe objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term.BackgroundAlthough a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients.MethodsThe U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom. Data were collected prospectively on 870 patients undergoing 877 TAVI procedures up until December 31, 2009. Mortality tracking was achieved in 100% of patients with mortality status reported as of December 2010.ResultsSurvival at 30 days was 92.9%, and it was 78.6% and 73.7% at 1 year and 2 years, respectively. There was a marked attrition in survival between 30 days and 1 year. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction <30%), the presence of moderate/severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model.ConclusionsMidterm to long-term survival after TAVI was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year

Delegation ärztlicher Leistungen an rheumatologische Fachassistenten: Effekte auf Depression und Angst bei Patienten mit rheumatoider Arthritis

Background: At least 1 comorbidity occurs in 80% of patients with rheumatoid arthritis (RA). In addition to cardiovascular comorbidities psychological comorbid conditions are common. The prevalence of depression and anxiety is higher in patients than in the general population. Screening for comorbidities is crucial. A shortage of outpatient specialist care barely allows resources for this. The implementation of team-based care holds the potential to improve the standard of care while simultaneously working against the shortage of care. Objective: The aim of the study was to examine the effects of care on the course of depression and anxiety in patients with seropositive RA and active disease. Material and methods: A multicenter pragmatic randomized controlled trial was conducted over the course of 1 year with 224 patients. After baseline, five more visits followed. In the intervention group (IG), three were initially carried out by qualified rheumatological assistants. Depression, anxiety and patient satisfaction with outpatient care were looked at in detail. Results: In the IG the anxiety symptoms significantly improved over 12 months (p = 0.036). The proportions of patients with anxiety also significantly changed in the IG (p < 0.001), while there was no change in the control group between baseline and month 12. The values of the depression scale did not differ significantly (p = 0.866). In terms of the information dimension of the satisfaction questionnaire, patients in the IG felt significantly better informed after 6 months (p = 0.013) and 12 months (p = 0.003). Conclusion: A positive effect of team-based care on the course of depression and anxiety in patients with seropositive RA and active disease could be shown.Hintergrund: Bei 80 % der Patienten mit einer rheumatoiden Arthritis (RA) tritt mindestens eine Komorbidität auf. Neben kardiovaskulären Komorbiditäten sind psychische Erkrankungen häufig. Die Prävalenz von Depression und Angst ist bei Betroffenen höher als in der Allgemeinbevölkerung. Ein Screening auf Komorbidität ist hoch relevant. Die Unterversorgung im fachärztlichen Bereich lässt dies kaum zu. Die Implementierung einer Visite durch die rheumatologische Fachassistenz (RFA) bietet Potenzial, die Versorgung zu verbessern und der Unterversorgung zu begegnen. Fragestellung: Ziel ist, Auswirkungen einer teambasierten Versorgung auf den Verlauf von Depression und Angst bei Patienten mit einer seropositiven RA im Krankheitsschub zu untersuchen. Material und Methoden: Es handelt sich um eine multizentrische, pragmatische, randomisierte, kontrollierte Studie über 1 Jahr mit 224 Patienten. Nach Baseline folgen 5 Visiten. In der Interventionsgruppe (IG) fanden 3 zunächst bei der RFA statt. Depression, Angst und Behandlungszufriedenheit werden genauer betrachtet. Ergebnisse: In der IG hat sich die ängstliche Symptomatik über 12 Monate signifikant verbessert (p = 0,036). Auch die Anteile der Patienten mit Ängstlichkeit verändern sich signifikant in der Interventionsgruppe (p < 0,001), während es in der Kontrollgruppe im Vergleich zwischen Baseline und Monat 12 zu keiner Veränderung kam. Die Werte der Depressionsskala unterschieden sich nicht signifikant (p = 0,866). Bei der Dimension „Information“ des Zufriedenheitsfragebogens haben sich die Patienten in der IG nach 6 (p = 0,013) und 12 Monaten (p = 0,003) signifikant besser informiert gefühlt. Diskussion: Ein positiver Effekt der teambasierten Versorgung auf den Verlauf von Depression und Angst bei Patienten mit einer seropositiven RA im Krankheitsschub konnte gezeigt werden