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Polyvagal theory is a neurobiological approach developed by Dr. Stephen W. Porges to explain the physiological basis of social behaviors and emotional responses from the perspective of the autonomic nervous system. The theory is based on an understanding of the vagus nerve and its role in the autonomic nervous system. The theory identifies three evolutionary layers of the autonomic nervous system that show different responses to threat and safety. The theory emphasizes that the ability to switch between the different vagus nerve modes is crucial for adaptation to social situations and for the perception of safety. A well-regulated ventral vagus contributes to a sense of safety and social connectedness. In a clinical setting, polyvagal theory can help to develop therapeutic approaches that promote the regulation of the autonomic nervous system. This article explores various aspects of this theory, including its application in a therapeutic context. [ABSTRACT FROM AUTHOR]

The article "Tailored Sun Protection: Sunscreen for each of us for better light protection" discusses the diversity of needs in sun protection and the necessity to offer individual solutions. Various UV filters that can be used in sun protection products are discussed, and their safety and effectiveness are explained. The article emphasizes the importance of the photostability of UV filters and suggests formulations based on stable UV filters. It also covers the history of sunscreens and their development over time. The article does not contain any relevant information or texts that can be used for a summary. [Extracted from the article]

The introduction of hydrogen as a safe energy carrier needs a robust knowledge base, tools for the design and safety assessment of hydrogen technologies built on it, and an internationally harmonised set of rules. Many of the innovative technologies imply hydrogen at high pressures and/or cryogenic temperatures, with which private users come into contact for the first time in distributed applications. In order to avoid over‐conservative, expensive safety solutions, while demonstrating the feasibility and safety of hydrogen applications and maintaining acceptance for the technology, also safety research must keep pace with, or better anticipate, trends in technological development. Thus, this overview article describes not only the current state of knowledge and technology regarding hydrogen safety, but also its further development. [ABSTRACT FROM AUTHOR]

Paragraph 2 of the Driving License Ordinance (FeV) defines the relevant share of responsibility for every vehicle driver: Those who cannot move safely in traffic and pose a risk to themselves or others must refrain from driving a motor vehicle. The taking of medication should not be assessed differently from symptoms caused by a severe flu-like infection or gastrointestinal disorder. The assessment of drivers who have been treated with painkillers on a long-term basis with regard to their ability to safely participate in road traffic is complex and, including fundamental considerations, generally also requires a case-by-case approach and, if necessary, an assessment. The typical undesirable effects of most pain medication, especially WHO II and III, can potentially and usually only temporarily put this fitness to drive into question. On the other hand, taking painkillers can make driving possible in the first place. The ability to drive can be impaired in particular when dosing, changing substances, changing doses, supplementing co-medication and also discontinuing substances. A period of 2 weeks for not driving a motor vehicle can be considered useful here. The requirement for safety is to be set even higher for driving license group 2, professional drivers, bus drivers, passenger transport. In this context, road users are required to have a high level of character aptitude. There are trend-setting publications penned by the assessment criteria working group of the German Society for Traffic Psychology (DGVP). [ABSTRACT FROM AUTHOR]

The article describes the controlled refrigerator hibernation of European tortoises. It is recommended to carry out the hibernation in a separate hibernation refrigerator to ensure the well-being of the animals during hibernation. Greek tortoises, marginated tortoises, and some Testudo graeca subspecies undergo winter hibernation. Refrigerator hibernation offers advantages such as the ability to monitor the animals during hibernation and the lower technical effort compared to hibernation in a pit. Exclusion criteria are also mentioned, where hibernation cannot take place, as well as preparations and safety measures for refrigerator hibernation. [Extracted from the article]

How safe are our structures? – Conceptual paper of the DGGT Working Group 2.15 "Reliability‐Based Methods in Geotechnical Engineering" The future Eurocode 7 will explicitly allow the use of reliability‐based methods in geotechnical planning and design. In Germany, there is hardly any experience in the practical application of such methods so far and thus the reservations towards these methods are plenty. The new DGGT Working Group (WG) 2.15 "Reliability‐Based Methods in Geotechnical Engineering" has set itself the goal of providing a practical access to those methods by means of practice‐oriented instructions and recommendations as well as accompanying training and further education courses. The aim is to clarify the possibilities and limitations and, above all, to exploit their potential. This article presents the general principles as well as the future fields of work of the WG 2.15. Starting with the introduction of relevant technical terms, the implementation of reliability‐based methods within the current codes of practice and regulations is shown. Using the life cycle of a geotechnical structure, the uncertainties in geotechnical designs and assessments are described. Subsequently it is outlined, in which situations and to what extend reliability‐based methods can aid engineers, clients and inspectors in verification and decision‐making processes. In the future, WG 2.15 will develop recommendations on individual topics and publish them successively. [ABSTRACT FROM AUTHOR]

Background and objectives: Dangerous situations in connection with the treatment of persons with suspected extremist attitudes have become increasingly relevant. A survey of physicians and psychotherapists is intended to provide information about concrete dangerous situations among these patients. Materials and methods: By means of an anonymous online survey, which comprised 16 main questions and up to 95 additional questions, a total of 364 health professionals were asked about the general situation and about patients, as well as relatives with suspected extremist attitudes. Results: In all, 17.5% of the participants were physicians, 72.1% psychotherapists. 47.7% work exclusively in a hospital, 34.2% in a private practice. A total of 57.7% of the participants have already treated patients with suspected extremist attitudes (46.7% treated relatives); 27.6% were confronted with situations of self-endangerment (30.1% in the case of relatives), 49.5% with situations of danger to others (18.3% in the case of relatives), in which they often did not feel safe. Altogether, 20.3% of the professionals informed security authorities, and not quite half found this contact to be comparatively unhelpful/not at all helpful (45.5% among relatives). The majority of the participants had no contact to other agencies, such as specialized counselling centres for deradicalization. Physicians experienced the situations of endangerment more often than non-medical psychotherapists. A comparison between professionals from hospitals and private practices shows no significant differences. Discussion: The study was able to show that extremism and the associated dangerous situations are an important topic in the treatment of patients and that physicians and non-medical psychotherapists should be well prepared. Networking with extremism prevention agencies and good cooperation with security authorities would be important and desirable for the future. [ABSTRACT FROM AUTHOR]

Background: For children aged 6-11 years with uncontrolled severe atopic dermatitis (AD), 16 weeks of treatment with dupilumab resulted in substantial clinical benefit compared with placebo with an acceptable safety profile. However, longer-term safety and efficacy data are important to inform longitudinal AD management. Objectives: This analysis of data from an open-label extension study (LIBERTY AD PED-OLE, NCT02612454) reports the long-term safety, efficacy, and pharmacokinetics of dupilumab in children with severe AD who had participated in the pivotal dupilumab LIBERTY AD PEDS study (NCT03345914). Methods: Enrolled patients initially received subcutaneous dupilumab 300 mg every 4 weeks (q4w). The q4w regimen could be uptitrated to dupilumab dose regimens of 200 or 300 mg every 2 weeks (q2w; for body weight < 60 or ≥ 60 kg, respectively) for patients who did not achieve an Investigator's Global Assessment (IGA) score of 0/1 (clear/almost clear skin) at week 16, or prior to week 16 as rescue treatment. Additional patients were uptitrated to a weight-tiered q2w regimen following a protocol amendment. Patients who maintained an IGA score of 0/1 continuously for a 12-week period after week 40 discontinued dupilumab. They were monitored for relapse and were reinitiated on dupilumab if required. Results: Data for 321 patients (mean age 8.6 years) were analyzed, 254 (79%) of whom had completed the scheduled 52-week visit at the database lock. Most treatment-emergent adverse events were mild/moderate. By week 52, 41% of patients achieved an IGA score of 0/1, and 97%, 82%, and 50%, respectively, had at least a 50%, 75%, and 90% improvement from the parent study baseline in Eczema Area and Severity Index (EASI). By week 52, 29% of patients in the overall population had clear/almost clear skin sustained for 12 weeks and had stopped medication; of these, 40% relapsed and were subsequently reinitiated on treatment, with a mean time to reinitiation of 13.5 (standard deviation 5.2) weeks. Following reinitiation of dupilumab, 41% of the patients with evaluable data at the time of database lock had regained an IGA 0/1 clinical response. Conclusions: Consistent with results seen in adults and adolescents, long-term treatment with dupilumab in children aged 6-11 years with severe AD showed an acceptable safety profile and incremental clinical benefit. A substantial proportion of children who stopped dupilumab treatment after achieving clear/almost clear skin subsequently experienced disease recurrence, and required reinitiation of dupilumab, suggesting that continuous treatment may be necessary for maintenance of clinical benefit. Trial registration: ClinicalTrials.gov Identifier NCT02612454. [ABSTRACT FROM AUTHOR]

Background: A good safety culture may be predominantly defined by an open and unsanctioned communication about critical and erroneous courses. In an effort to improve patient safety various instruments, such as the critical incident reporting system (CIRS) or in terms of patient handover, the use of the situation, background, assessment, recommendation (SBAR) system patient handover, have been developed and are recommended by the German Society of Anaesthesiology and Intensive Care Medicine (DGAI). This study aimed at identifying how anesthesiologists perceive the safety culture in their current department and whether CIRS or SBAR are already established or not.Material and Methods: All registered members of the DGAI and the Professional Association of German Anaesthesiologists (BDA, n = 19,042) were invited to participate in an online survey on patient safety. In this survey there was a focus on the perceived safety culture and the experience with CIRS and SBAR.Results: Of the participants 76.6% (n = 1372) stated that their department of anesthesiology has a good safety culture, while in 23.4% (n = 419) there was not. For the whole hospital the safety culture was only rated as being positive by 54.3% (n = 949) of the respondents. An open communication about critical and erroneous courses occurred in 76.5% (n = 1375) according to the participants, 23.0% (n = 408) had the impression that in the case of errors the respective person was being denounced. In one third of the participants' departments (n = 630, 36.6%) there were no morbidity and mortality conferences. The acronym CIRS was familiar to 98.9% (n = 1801) of the participants, 84.8% (n = 1544) of the surveyed anesthesiologists reported that CIRS was established in their departments. Critical incidents have been reported via CIRS by 54.4% (n = 839) of the respondents. Only 29.4% (n = 462) of the participants received regular feedback on CIRS reports. The acronym SBAR as a handover tool is unknown to the majority of the surveyed participants (n = 1181, 63.7%) and 86.1% (n = 1554) consider using an instrument in order to improve handover quality as possibly being beneficial.Conclusion: Anesthesiologists rate the quality of the safety culture of their own anesthesiology department to be higher compared to their hospital in general. In some hospitals there is denouncement in cases of erroneous courses according to the respondents. In the patients' point of view morbidity and mortality conferences should be established more often. CIRS is known to almost every surveyed anesthetist but feedback on a regular basis is sparse. This contradicts the claims of the German Coalition for Patient Safety. The acronym SBAR is unknown to the majority of surveyed participants despite the recommendation of the DGAI to implement it. There is a wish for tools in order to enhance the quality of handovers. [ABSTRACT FROM AUTHOR]

Surgical interventions should ideally treat an existing disease curatively and achieve this with a low complication rate and minimal trauma. In this sense, laparoscopic cholecystectomy has become established as the recognized standard for the treatment of cholecystolithiasis. Newer procedures, such as single-port surgery or natural orifice transluminal endoscopic surgery (NOTES) have recently emerged to reduce the already low interventional trauma even further and to provide a better cosmetic outcome. With all new methods the main aim is the reduction of the transabdominal access points. Based on published results and diagnosis-related groups (DRG) data, this article examines whether this goal has been achieved, also with respect to the overall quality of treatment and the complication rates. In this context and in addition to the already mentioned approaches, robotic cholecystectomy and the reduced port approach are also considered. [ABSTRACT FROM AUTHOR]

Background: Psychiatric disorders during pregnancy are common. Electroconvulsive therapy (ECT) can be indicated in severely affective or psychotic disorders with the necessity of a rapid response. Currently available review articles greatly differ in the methodology, leading to divergent conclusions concerning the use of ECT during pregnancy. Objective: Description of a new clinical case and interdisciplinary treatment suggestions for the safe application of ECT in pregnancy. Methods: Clinical case report and selective review of the literature with special consideration of existing systematic reviews. Results and conclusion: This case report shows the potentially high effectiveness and safe administration of ECT in pregnancy for both mother and fetus. The undesired adverse events associated with ECT described in the literature are largely qualitatively congruent with the risks of severe psychotic disorders in pregnancy per se. For a better risk-benefit analysis, larger case control studies would be desirable. Under the premise of a thorough evaluation of the indications, good interdisciplinary coordination and consideration of the specific practical requirements, ECT is a useful therapeutic option in pregnancy. [ABSTRACT FROM AUTHOR]

Background: Effective, well-tolerated oral psoriasis treatments are needed. Objective: To compare the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis. Methods: Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). Coprimary end points included response rates for ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) with deucravacitinib versus placebo at week 16. Results: At week 16, response rates were significantly higher with deucravacitinib versus placebo or apremilast for PASI 75 (194 [58.4%] vs 21 [12.7%] vs 59 [35.1%]; P <.0001) and sPGA 0/1 (178 [53.6%] vs 12 [7.2%] vs 54 [32.1%]; P <.0001). Efficacy improved beyond week 16 and was maintained through week 52. Adverse event rates with deucravacitinib were similar to those with placebo and apremilast. Limitations: One-year duration, limited racial diversity. Conclusion: Deucravacitinib was superior to placebo and apremilast across multiple efficacy end points and was well tolerated in moderate to severe plaque psoriasis. [ABSTRACT FROM AUTHOR]

Introduction: Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications. Methods: SERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Patients should have received at least 16 weeks of secukinumab treatment before enrolment in the study. Results: Overall 2800 patients were included in the safety set; patients with PsA (N = 541) were older than patients with PsO (N = 1799) and patients with AS (N =  460); patients with PsO had a higher mean body weight than patients with PsA and patients with AS; and patients with PsO and patients with AS were predominantly male. Time since diagnosis was longer in patients with PsO compared with patients with PsA and patients with AS, and about 40% of patients were either current or former smokers. The proportion of obese patients (body mass index ≥ 30 kg/m2) was similar across indications. Patients were treated with secukinumab for a mean duration of 1 year prior to enrolment (range 0.89–1.04). The percentages of patients with prior biologics exposure were 31.5% PsO, 59.7% PsA and 55% AS. The percentages of patients prescribed secukinumab monotherapy were 75% (n =  1349) in PsO, 48.2% (n = 261) in PsA and 48.9% (n = 225) in AS groups. Conclusion: Baseline demographics of the study population are consistent with existing literature. This large observational study across all secukinumab indications will provide valuable information on the long-term effectiveness and safety of secukinumab in the real-world setting. [ABSTRACT FROM AUTHOR]

The article discusses relationship between biopolitics and education by using the example of the COVID-19 pandemic. Topics discussed include relationship between biopolitics and education in the ways and forms of speech on the subject of school and health before pandemic; information on distance rules and protective measures for educational institutions; and concept of power to the category of domination and related political connotations.

Opioid maintenance treatment with methadone or buprenorphine is an established first-line treatment for opioid dependence. In addition to the novel weekly and monthly subcutaneously injectable buprenorphine depot CAM 2038 (Buvidal®), which is already available in Germany, two other long-acting buprenorphine formulations may be introduced in the near future: the monthly depot formulation RBP-6000 (Sublocade™) and a 6-month buprenorphine depot implant (Probuphine™). Basic pharmacological and clinical data of these three medications are given and possible clinical applications are discussed. [ABSTRACT FROM AUTHOR]

Gut microbiota dysbiosis is involved in the development of systemic lupus erythematosus (SLE). The safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of SLE patients has not been explored. In this 12-week, single-arm pilot clinical trial of oral encapsulated fecal microbiome from healthy donors to patients with active SLE, we aimed to evaluate the safety and efficacy of FMT in patients with SLE (ChiCTR2000036352). 20 SLE patients with SLEDAI ≥6 were recruited. FMT was administered once a week for three consecutive weeks along with standard treatment and the patients were followed for 12 weeks. Safety was evaluated throughout the trial. The primary endpoint was the SLE Responder Index-4 (SRI-4) at week 12. Microbiome composition, levels of short chain fatty acids (SCFAs) in the gut and of cytokines in the sera were measured along with lymphocyte phenotyping. No serious adverse events were observed after FMT. At week 12, the SRI-4 response rate was 42.12%, and significant reductions in the SLEDAI-2K scores and the level of serum anti-dsDNA antibody were observed compared to baseline. Significant enrichment of SCFAs-producing bacterial taxa and reduction of inflammation-related bacterial taxa were observed, along with increased production of SCFAs in the gut and reduced levels of IL-6 and CD4+ memory/naïve ratio in the peripheral blood. Furthermore, SRI-4 responding patients displayed specific microbiota signatures both before and after FMT. The first clinical trial of FMT in active SLE patients provides supportive evidence that FMT might be a feasible, safe, and potentially effective therapy in SLE patients by modifying the gut microbiome and its metabolic profile. [ABSTRACT FROM AUTHOR]

Background: The treatment of pemphigus is based on systemic corticosteroid use and adjuvant therapies, but some patients are resistant to conventional therapy. Tirabrutinib is a highly selective oral Bruton's tyrosine kinase inhibitor that may be clinically effective in treating pemphigus by suppressing B-cell signaling. Objective: We investigated the efficacy and safety of tirabrutinib in patients with refractory pemphigus. Methods: This was a multicenter, open-label, single-arm phase 2 study of Japanese patients with refractory pemphigus receiving appropriate treatment with an oral corticosteroid and adjuvant therapies. Patients received postprandial oral tirabrutinib 80 mg once daily for 52 weeks. After 16 weeks of tirabrutinib treatment, the corticosteroid dose was tapered to ≤10 mg/day of prednisolone equivalent. Results: In total, 16 patients were evaluated (mean age, 52.5 years; 50% male). The complete remission rate after 24 weeks of treatment (primary endpoint) was 18.8% (3/16; 95% confidence interval, 6.6%-43.0%). By Week 52, eight patients (50.0%) achieved complete remission and 10 patients (62.5%) achieved remission. Over 52 weeks of treatment, the mean prednisolone dose decreased from 17.03 to 7.65 mg/day. Incidences of adverse events (AEs) and adverse drug reactions were 87.5% and 43.8%, respectively. A relationship with tirabrutinib was ruled out for all serious AEs and Grade ≥3 AEs. Conclusion: Treatment with tirabrutinib enabled remission and reduced oral corticosteroid exposure over time and did not result in any major safety concerns in patients with refractory pemphigus. Thus, oral tirabrutinib may be a new treatment option for patients with refractory pemphigus. [ABSTRACT FROM AUTHOR]

Emergency pharmacotherapy is one of the most commonly used medical procedures. At the same time, pharmacotherapy in an emergency is always a potentially dangerous action. Medication errors are even among the most frequently registered errors in medicine. Due to the special circumstances in emergency medicine, special precautions are required to ensure the safety of drug therapy. In addition to the important background information, this article presents procedures that are recognized and applicable in daily routine to increase safety in pharmacotherapy. [ABSTRACT FROM AUTHOR]

Hintergrund: Die „pressurized intraperitoneal aerosol chemotherapy" (PIPAC) ist ein neuer Baustein in der Behandlung von Patienten mit Peritonealkarzinose. Durch laparoskopische Applikation eines Aerosols aus Chemotherapeutika im Abdomen kann eine lokale Wirkung erreicht werden. Dies kann zusammen mit einer systemischen Therapie durchgeführt werden.Methodik: Wir haben im Rahmen einer Registerstudie die Daten unserer ersten 111 PIPAC-Prozeduren prospektiv dokumentiert und ausgewertet. Die Betrachtung fokussiert die perioperative Patientensicherheit und die Sicherheit am Arbeitsplatz. Die perioperativen klinischen Patientendaten wurden analysiert und die Platinkonzentration im Operationssaal mittels Wischproben geprüft.Ergebnisse: Insgesamt 62 Patienten konnten für eine PIPAC geplant und 121 Operationen durchgeführt werden. 9‑mal konnte kein sicherer Zugang in das Abdomen erzielt werden. 54 Patienten erhielten 111 PIPAC-Behandlungen. Ein Patient verstarb infolge einer Darmperforation, 6 Zugangsläsionen am Darm konnten umgehend versorgt werden und heilten problemlos. Ein weiterer Patient entwickelte ein postoperatives Nierenversagen. Ansonsten zeigten sich keine Majorkomplikation und keine Toxizität.Diskussion: Die PIPAC kann gut als Ergänzung einer systemischen medikamentösen Behandlung bei Peritonealkarzinose appliziert werden. Wichtig ist die Selektion der geeigneten Patienten. Die PIPAC ist ein risikoarmes Verfahren, wenn die Durchführung unter strengen Indikationskriterien und standardisierten Bedingungen stattfindet - für Patienten und für Ärzte. [ABSTRACT FROM AUTHOR]

European space flight has emerged to master challenges collectively, ensuring Europe's independent access to space. In the meantime, not only the demand, quality and scope of European space activities have increased. The Treaty of Lisbon and the associated expansion of European Union competence also raise the question of whether space and security can once again act as a binding link with a view to a common European Defense Union. [ABSTRACT FROM AUTHOR]

Hintergrund: Der Mini-gastric-Bypass/One-anastomosis-gastric-Bypass (MGB/OAGB) war im Jahr 2017 mit 1044 Eingriffen (13,9 % der Gesamtoperationen, StuDoQ|MBE) der dritthäufigste operative Eingriff für Adipositas in Deutschland.Ziel der Arbeit: Diese Analyse soll die aktuelle Evidenz des MGB/OAGB und die historische Evidenz zur Einschlingenrekonstruktion wiedergeben.Material und Methoden: Es erfolgte eine systematische Literaturanalyse in der elektronischen Datenbank MEDLINE via PubMed und im Studienregister Clinicaltrials.gov. Wir fanden 35 relevante Artikel: 19 retrospektive Studien, 8 retrospektive Vergleichsstudien, 2 Übersichtsarbeiten, 3 systematische Reviews und Metaanalysen und 3 prospektiv randomisiert kontrollierte Studien. In Clinicaltrials.gov waren 8 prospektiv randomisierte Studien registriert.Ergebnisse: Nach MGB/OAGB betrug die 30-Tage-Mortalität 0-0,9 %, interventionspflichtige Komplikationen traten bei einer perioperativen Gesamtmorbidität von 3,2-10,8 % zu 0,8-7 % auf. Der „total weight loss“ betrug 31-38 % nach einem und 23-32 % nach 5 Jahren. In allen Arbeiten zeigte sich eine positive Wirkung auf die metabolischen Begleiterkrankungen. Studien zu harten Endpunkten wie „Endorganschäden bei Diabetes“, „Reduktion kardiovaskulärer Ereignisse“ und eine Verlängerung des Überlebens existieren bislang nur für den Roux-Y-Magenbypass.Diskussion: Der MGB/OAGB hat eine geringe perioperative Komplikationsrate und bietet kurzfristig Vorteile bezüglich des Gewichtsverlusts und des antidiabetischen Wirkungsgrades im Vergleich zu den etablierten Standardverfahren Roux-Y-Magenbypass und Schlauchmagen. Der Stellenwert des biliären Refluxes und einer damit verbundenen Möglichkeit der Entartung im Langzeitverlauf ist derzeit unklar. Bisher ausstehende Ergebnisse der registrierten prospektiv randomisierten Studien werden in Zukunft eine bessere Evidenz bieten können. [ABSTRACT FROM AUTHOR]

Background: Correct positioning of a central venous catheter (CVC) tip in pediatric patients is very important. Malpositioning may lead to direct complications, such as arrhythmia and increase the risk of thrombosis, infections, valve failures or pericardial tamponade.Objective: The aim of this review was to identify and summarize published formulae for the correct positioning of the CVC tip in children and to discuss the benefits of these formulae for the daily routine.Material and Methods: A systematic and standardized search in Medline and PubMed was performed to identify published formulae. Formulae for insertion depth of the CVC tip over the right internal jugular vein are discussed. The keywords "pediatric" or "pediatric", "children", "central venous catheter", "CVC", "central venous", "length", "insertion", "optimal", "formula", "depth", "correct position" and "right position", "internal jugular vein" were used to identify the formulae.Results: A total of 854 publications were found and 127 publications were analyzed. The publications were subsequently assessed and classified independently by a specialist in anesthesiology and a specialist in pediatrics. A total of six publications described different body height-based formulae for calculation of a CVC insertion depth. No prospective evaluation of these formulae was performed to show if it is possible to place a CVC tip at the optimal position.Conclusion: The benefit of a formula for daily practice is very limited due to the problem of choosing the right insertion point. The recommended insertion depth should be considered as an indicator and a verification of the CVC tip position should be done using an imaging technique. [ABSTRACT FROM AUTHOR]

Regional anesthesia has undergone many changes over the years and the increasing use of ultrasound has certainly played an important role in this. Apart from individual case reports in the literature of very different blocking options, some new procedures seem to have become established and can be broadly applied. Among these are blockades, by which ultrasound-guided injection of local anesthetics is carried out in fascial or muscular layers rather than around target nerves (e.g. cervical plexus blocks and truncal blocks). In addition, the precision with which ultrasound can be used to identify nerve structures led to an increasingly better definition of targets exemplified for interscalene or femoral nerve blocks. The use of ultrasound also seems to be helpful in the performance of neuraxial blocks, particularly in obese patients or patients with a difficult anatomy. With the implementation 10 years ago of a registry for safety in regional anesthesia and acute pain therapy by the German Society of Anesthesiology and Intensive Care Medicine (DGAI) and the Association of German Anesthesiologists (BDA), it has been possible to answer important safety questions and define protective measures (e.g. tunnelling, antibiotic prophylaxis and sedation). Moreover, this registry can be used as a benchmark to compare the quality of regional anesthesia in individual hospitals with all other participating centers. [ABSTRACT FROM AUTHOR]

Background: Real-world evidence (RWE) expands the data obtained in randomized clinical trials (RCTs), which are based on both homogeneous selected patient groups and limited study durations, to long-term experiences in clinical routine. In particular, chronic diseases such as multiple sclerosis (MS) with both heterogeneous pathologies and a growing number of therapeutic options require a careful RWE-based assessment of long-term efficacy and safety parameters. Objective: This review presents RWE data sources applied in MS research and discusses potential quality standards. Material and methods: This article is based on the results of an expert meeting of the authors held in October 2015 and a selective literature search. Results: The RWE data sources include the reporting system of drug safety monitoring, non-interventional studies, MS-specific registries, administrative health databases, and electronic medical records. These data sources have different objectives and are subject to specific limitations with respect to the disease and therapy-relevant analytical options. The combination of different sources into an integrative approach might improve the validity of RWE in MS research; however, this objective requires the standardization of data collection and processing as well as the definition of uniform and transnational quality standards. Conclusion: There is still a need for high-quality, comprehensive, and valid RWE data as these data cover additional aspects of patient care and expand the data available by complementary information. Further development of an integrative RWE approach requires cooperation at various levels with the aim of the best possible standardization and harmonization of clinical MS data. [ABSTRACT FROM AUTHOR]

The article "Filler - Better with Safety!" reports on the increasing demand for minimally invasive aesthetic treatments in Germany and the associated unwanted side effects. Dr. Simone Vogel, specialist in dermatology, venereology, and allergology, explains how she has dealt with the side effects of filler and Botox injections. She is part of the International Society for Aesthetic Competence (IS4AC), which aims to open a national and international intercollegiate channel to report unwanted events and provide support in therapy. The IS4AC will also contribute to the S1 guideline "Management of complications in aesthetic filler injections." [Extracted from the article]

Introduction: Mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, can lead to disfiguring lesions, debilitating pruritus and frequent skin infections. This study assessed response to brentuximab vedotin in patients with MF in the phase III ALCANZA study. Methods: Baseline CD30 levels and large-cell transformation (LCT) status were centrally reviewed in patients with previously-treated CD30-positive MF using ≥2 skin biopsies obtained at screening; eligible patients required ≥1 biopsy with ≥10% CD30 expression. Patients were categorised as CD30min < 10% (≥1 biopsy with <10% CD30 expression), or CD30min ≥ 10% (all biopsies with ≥10% CD30 expression) and baseline LCT present or absent. Efficacy analyses were the proportion of patients with objective response lasting ≥4 months (ORR4) and progression-free survival (PFS). Results: Clinical activity with brentuximab vedotin was observed across all CD30 expression levels in patients with ≥1 biopsy showing ≥10% CD30 expression. Superior ORR4 was observed with brentuximab vedotin versus physician's choice in patients: with CD30min < 10% (40.9% versus 9.5%), with CD30min ≥ 10% (57.1% versus 10.3%), with LCT (64.7% versus 17.6%) and without LCT (38.7% versus 6.5%). Brentuximab vedotin improved median PFS versus physician's choice in patients: with CD30min < 10% (16.7 versus 2.3 months), with CD30min ≥ 10% (15.5 versus 3.9 months), with LCT (15.5 versus 2.8 months) and without LCT (16.1 versus 3.5 months). Safety profiles were generally comparable across subgroups. Conclusion: These exploratory analyses demonstrated that brentuximab vedotin improved rates of ORR4 and PFS versus physician's choice in patients with CD30-positive MF and ≥1 biopsy showing ≥10% CD30 expression, regardless of LCT status. Clinical trial registration: Clinicaltrials.gov, NCT01578499. [ABSTRACT FROM AUTHOR]

In the western World 16 October 1846 is often called 'Ether Day', marking the beginning of anesthesia. Before that date, for physicians there was only a struggle against pain. In the following 170 years all fields of general anesthesia as well as regional and local anesthesia were continuously developed. Pharmacological developments and technical innovations made this evolution possible. The complexity of this field of medicine requires a specialist: the anesthesiologist, whose selection of the most suitable form of anesthesia for the patient makes the surgical intervention painless. In addition, the history of anesthesia was characterized by personalities who were responsible for the progress of this medical field. Anesthesia is one part of the discipline of anesthesiology, which also includes resuscitation, intensive care medicine, emergency medicine and pain therapy. [ABSTRACT FROM AUTHOR]

Electronic cigarettes (e-cigarettes) are vaporisers of liquids often containing nicotine. In the inhaled aerosol carcinogens, ultrafine and metal particles are detected usually in concentrations below those measured in tobacco smoke. Therefore, these products are expected to be less harmful. This has not yet been proven. The long-term safety of e-cigarettes is unknown. Short duration use leads to airway irritation and increased diastolic blood pressure. So far only two randomised controlled trials have investigated efficacy and safety of e-cigarettes for smoking cessation: No clear advantage was shown in comparison to smoking cessation medication. Due to insufficient evidence, e-cigarettes cannot be recommended for smoking cessation. Problematic are the lack of regulation and standardisation of e-cigarette products, which makes general conclusions impossible. [ABSTRACT FROM AUTHOR]

Background: Inadvertent intra-arterial injection of dermal fillers including calcium hydroxylapatite (CaHA) can result in serious adverse events including soft tissue necrosis, permanent scarring, visual impairment, and blindness. When intra-arterial injection occurs, immediate action is required for optimal outcomes, but the infrequency of this event means that many physicians may never have experienced this scenario. The aim of this document is to provide evidence-based and expert opinion recommendations for the recognition and management of vascular compromise following inadvertent injection of CaHA. Subjects and methods: An international group of experts with experience in injection of CaHA and management of vascular complications was convened to develop a consensus on the optimal management of vascular compromise following intra-arterial CaHA injection. The consensus members were asked to provide preventative advice for the avoidance of intravascular injection and to produce a treatment protocol for acute and delayed presentation. To ensure all relevant treatment options were included, the recommendations were supplemented with a PubMed search of the literature. Results: For prevention of intra-arterial CaHA injection, consensus members outlined the importance of a thorough knowledge of facial vascular anatomy and patient history, as well as highlighting potential risk zones and optimal injection techniques. Individual sections document how to recognize the symptoms of vascular occlusion leading to vision loss and tissue necrosis as well as detailed treatment protocols for the management of these events. For impending tissue necrosis, recommendations are provided for early and delayed presentations with treatment protocols for acute and follow-up treatment. A separate section details the treatment options for open and closed wounds. Conclusion: All physicians should be prepared for the eventuality of intra-arterial injection of a dermal filler, despite its rarity. These consensus recommendations combine advice from aesthetic experts with the latest reports from the published literature to provide an up-to-date office-based protocol for the prevention and treatment of complications arising from intra-arterial CaHA injection. [ABSTRACT FROM AUTHOR]

Pegylation of pharmacological substances was developed in the 1970s as a way of improving their efficacy and elimination and hence reducing the dosage frequency. A prominent example is pegylation of IFNα, which revolutionized the treatment of virus hepatitis in the late 1990s. Efforts have now succeeded in producing a pegylated interferon beta (PEG-IFN-β) to treat multiple sclerosis (MS) and the efficacy and safety have been investigated in a phase III trial called the ADVANCE study. The 1-year results of this randomized, double blind, multicenter, placebo-controlled study in more than 1500 MS patients show that administration of subcutaneous PEG-IFN-β significantly reduces the annual relapse rate and disability progression. The safety and tolerability profile of PEG-IFN-β was found to be similar to that of conventional IFN-β drugs. The most common adverse events were flu-like symptoms and redness at the injection site. The results of this study underscore that PEG-IFN-β is an interesting new therapeutic option in the treatment of relapsing-remitting MS that combines highly effective interferon with the established tolerability and safety profile of IFN-β at a reduced dosage frequency. [ABSTRACT FROM AUTHOR]

Business companies, which in the current times also includes hospitals, must create customer benefits and as a prerequisite for this must sustainably generate profits. Management in the world of business means the formation and directing of a company or parts of a company on a permanent basis, whereby management in this context is not exercising power but function. This concept of management is exemplary developed in this article for the important services sector of the operating room (OR) and individual functions, such as resource control, capacity planning and materials administration are presented in detail. Some OR-specific management challenges are worked out. From this it becomes clear that the economic logic of the most efficient implementation possible is not a contradiction of medical ethics, enabling the most effective treatment possible for patients while safeguarding the highest possible levels of safety and quality. The article aims to build a bridge for medical specialists to the language and world of commerce, emphasizing the profession-based competence and hopefully to arouse interest to go into more detail. [ABSTRACT FROM AUTHOR]

Anti-interleukin-17 agents have recently been developed for the treatment of psoriasis. This study evaluated the tolerance and effectiveness of anti-interleukin-17 agents for psoriasis in elderly patients in daily practice. A multicentre, retrospective study was performed, involving psoriatic patients aged ≥65 years who had received an anti-interleukin-17 agent, including secukinumab, ixekizumab or brodalumab. A total of 114 patients were included: 72 received secukinumab, 35 ixekizumab, and 7 brodalumab. Treatment was stopped in 32 patients (28.9%), because of relapses in 14 patients (41.2%), primary failures in 11 patients (32.4%), or adverse events in 7 patients (20.6%). The 3 most frequently reported adverse events were injection site reactions (n = 4), oral candidiasis (n = 3), and influenza-like illness (n = 3). Regarding effectiveness, 80 patients (70%) reached a Physician Global Assessment score of 0/1, 6 months after treatment initiation. In conclusion, anti-interleukin-17 therapy appears to be an effective and safe therapeutic option for psoriasis treatment in patients aged ≥ 65 years. [ABSTRACT FROM AUTHOR]

Background: Demographic development leads to an increase in vascular interventions due to the increase in elderly and multimorbid patients. The aim of this study was to demonstrate the open interventional therapy options and their influence on staff and patients which have become possible due to the introduction of angio-hybrid operations including 3-D imaging Dyna-CT. Material and methods: The modifications with respect to radiation protection for staff, improvements for patients and the possibilities of operative 3-D imaging Dyna-CT are described based on the current literature. Results: The implementation of angio-hybrid operation theaters has resulted in new open interventional treatment options which can also be employed for high risk elderly patients with aortic and peripheral arterial pathologies. With hybrid operations the radiation exposure and contrast medium exposure can be reduced for patients and an improvement in the results can also be achieved. The implementation of 3-D imaging in the angio-hybrid operation theater could also lead to further improvements, especially for complex aortic procedures. Discussion: Using angio-hybrid operational procedures complex interventions can be carried out with more safety for patients and personnel. The implementation of 3-D imaging Dyna-CT offers additional interesting options for complex aortic procedures. [ABSTRACT FROM AUTHOR]

The correct setting of the ultrasound equipment is a perequisite for a high quality of the ultrasound examination. Both the B-mode ultrasonography, as well as the Doppler technique offer interesting alternative settings that are often inadequately used. This brief summary of basic settings should help the practicing clinicians in everyday life and motivate them to deal with the „knobs" of the ultrasound device. Good practical help will provided by the „Sonocave" an event regularly organized at the annual ultrasonic training Congress in Davos, where recognized experts will answer such „Knobology"-questions and demonstrate the appropriate settings also practically. [ABSTRACT FROM AUTHOR]

A report is presented from a March 30-31, 2012 conference in Moscow, Russia on the history of safety culture since the 19th century. Topics of discussion included the difference in attitudes of Germans and Russian towards risk, the balance between security and liberty in Russia, and the role of nobility in the dissolution of the Russian Empire.

The article discusses emergency management for libraries and archives, drawing on experiences from emergency preparedness and prevention training by the Notfallverbund Leipziger Archive und Bibliotheken (Emergency Association of Leipzig Archives and Libraries) in Leipzig, Germany. It considers purposes, organizational structure, and emergency personnel and equipment. It also provides a list of suggestions for setting up regional institutional cooperation for the protection of cultural property.