Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis

;irikizumab, a p19-directed antibody against interleukin-23, showed efficacy in the treatment of ulcerative colitis in a phase 2 trial. Methods: We conducted two phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab in adults with moderately to severely active ulcerative colitis. In the induction trial, patients were randomly assigned in a 3:1 ratio to receive mirikizumab (300 mg) or placebo, administered intravenously, every 4 weeks for 12 weeks. In the maintenance trial, patients with a response to mirikizumab induction therapy were randomly assigned in a 2:1 ratio to receive mirikizumab (200 mg) or placebo, administered subcutaneously, every 4 weeks for 40 weeks. The primary end points were clinical remission at week 12 in the induction trial and at week 40 (at 52 weeks overall) in the maintenance trial. Major secondary end points included clinical response, endoscopic remission, and improvement in bowel-movement urgency. Patients who did not have a response in the induction trial were allowed to receive open-label mirikizumab during the first 12 weeks of the maintenance trial as extended induction. Safety was also assessed. Results: A total of 1281 patients underwent randomization in the induction trial, and 544 patients with a response to mirikizumab underwent randomization again in the maintenance trial. Significantly higher percentages of patients in the mirikizumab group than in the placebo group had clinical remission at week 12 of the induction trial (24.2% vs. 13.3%, P<0.001) and at week 40 of the maintenance trial (49.9% vs. 25.1%, P<0.001). The criteria for all the major secondary end points were met in both trials. Adverse events of nasopharyngitis and arthralgia were reported more frequently with mirikizumab than with placebo. Among the 1217 patients treated with mirikizumab during the controlled and uncontrolled periods (including the open-label extension and maintenance periods) in the two trials, 15 had an opportunistic infection (including 6 with herpes zoster infection) and 8 had cancer (including 3 with colorectal cancer). Among the patients who received placebo in the induction trial, 1 had herpes zoster infection and none had cancer. Conclusions: Mirikizumab was more effective than placebo in inducing and maintaining clinical remission in patients with moderately to severely active ulcerative colitis. Opportunistic infection or cancer occurred in a small number of patients treated with mirikizuma

Citizen Science Case Studies and Their Impacts on Social Innovation

Social innovation brings social change and aims to address societal challenges and social needs in a novel way. We therefore consider citizen science as both (1) social innovation in research and (2) an innovative way to develop and foster social innovation. In this chapter, we discuss how citizen science contributes to society’s goals and the development of social innovation, and we conceptualise citizen science as a process that creates social innovation. We argue that both citizen science and social innovation can be analysed using three dimensions – content, process, and empowerment (impact). Using these three dimensions as a framework for our analysis, we present five citizen science cases to demonstrate how citizen science leads to social innovation. As a result of our case study analysis, we identify the major challenges for citizen science in stimulating social innovation

Social innovations for social cohesion in Western Europe: success dimensions for lifelong learning and education

YesIn addressing the EU2020 goals, skills shortage combined with increasing unemployment rates is to be primarily tackled in Western Europe; the common factor here is education. Education and lifelong learning (LL) are the key strands governing employability in the European labour market. Overarching concepts capable of addressing social challenges within education and LL that contribute towards better practices are seen as social innovations (SI). While SI in education is well founded in the developing countries, Europe is still in the process of gaining progressive momentum in this direction. In addressing various societal challenges, this study looks at observable trends in SI for education across Western Europe. About 30 innovations have been recorded across 11 countries that are essentially focussed on: social integration, alternative/new forms of education, digital learning, new learning arrangements, new LL strategies, early career planning, youth employment, quality improvements and new education standards, transition management, and entrepreneurial education.European Union’s Seventh Framework Programme for research, technological development and demonstration [grant number 612870]

How to Build Collective Capabilities: The 3C-Model for Grassroots-led Development

Capabilities need to be built from the bottom-up. Social innovations at the grassroots seek to present new solutions to existing social problems. However, since the poor suffer from limitations on their individual capabilities and agency, they engage in acts of collective agency to generate new collective capabilities that each individual alone would not be able to achieve. The question is: how can these acts of collective agency be initiated, supported and sustained in practice? What roles can development actors (such as the state, donors and NGOs) play in supporting these acts of collective agency? Drawing on the literature on social innovation, the capability approach, participation and empowerment, the paper argues that three crucial C-processes are integral conditions for promoting successful, scalable and sustainable social innovations at the grassroots, namely: (1) Conscientization; (2) Conciliation and (3) Collaboration. By linking the individual, collective and institutional levels of analysis, the paper demonstrates the importance of individual behavioural changes, collective agency and local institutional reforms for the success, sustainability and scalability of social innovations at the grassroots. The paper acknowledges conflict, capture and cooptation as potential limitations and recognizes the role of contextual factors in initiating, implementing and sustaining social innovations at the grassroots

Understanding social innovation in services industries

This paper puts forward a framework for understanding the relationship between service industries and social innovation. These are two, previously disconnected research areas. The paper explores ways in which innovation in services is increasingly becoming one of social innovation (in terms of social goals, social means, social roles and multi-agent provision) and how social innovation can be understood from a service innovation perspective. A taxonomy is proposed based on the mix between innovation nature and the locus of co-production. The paper additionally puts forward a theoretical framework for understanding social innovation in services, where the co-creation of innovation is the result of an interaction of competences and preferences of multiple providers, users/citizens, and policy makers. This provides the basis for a discussion of key avenues for future research in theory, measurement, organisation, appropriation, performance measurement, and public policy

Intra-arterial induction high-dose chemotherapy with cisplatin for oral and oropharyngeal cancer: long-term results

Intra-arterial (IA) chemotherapy for curative treatment of head and neck cancer experienced a revival in the last decade. Mainly, it was used in concurrent combination with radiation in organ-preserving settings. The modern method of transfemoral approach for catheterisation, superselective perfusion of the tumour-feeding vessel, and high-dose (150 mg m−2) administration of cisplatin with parallel systemic neutralisation with sodium thiosulphate (9 g m−2) made preoperative usage feasible. The present paper presents the results of a pilot study on a population of 52 patients with resectable stage 1–4 carcinomas of the oral cavity and the oropharynx, who were treated with one cycle of preoperative IA chemotherapy executed as mentioned above and radical surgery. There have been no interventional complications of IA chemotherapy, and acute side effects have been low. One tracheotomy had to be carried out due to swelling. The overall clinical local response has been 69%. There was no interference with surgery, which was carried out 3–4 weeks later. Pathological complete remission was assessed in 25%. The mean observation time was 3 years. A 3-year overall and disease-free survival was 82 and 69%, respectively, and at 5 years 77 and 59%, respectively. Survival results were compared to a treatment-dependent prognosis index for the same population. As a conclusion, it can be stated that IA high-dose chemotherapy with cisplatin and systemic neutralisation in a neoadjuvant setting should be considered a feasible, safe, and effective treatment modality for resectable oral and oropharyngeal cancer. The low toxicity of this local chemotherapy recommends usage especially in stage 1–2 patients. The potential of survival benefit as indicated by the comparison to the prognosis index should be controlled in a randomised study

Perceived preparedness of dental academic institutions to cope with the COVID-19 pandemic: a multi-country survey

Dental academic institutions are affected by COVID-19. We assessed the perceived COVID19 preparedness of these institutions and the characteristics of institutions with greater perceived preparedness. An international cross-sectional survey of dental academics was conducted from March to August 2020 to assess academics’ and institutional attributes, perceived preparedness, and availability of infection prevention and control (IPC) equipment. Principal component analysis (PCA) identified perceived preparedness components. Multilevel linear regression analysis assessed the association between perceived preparedness and fixed effect factors (academics’ and institutions’ attributes) with countries as random effect variable. Of the 1820 dental academics from 28 countries, 78.4% worked in public institutions and 75.2% reported temporary closure. PCA showed five components: clinic apparel, measures before and after patient care, institutional policies, and availability of IPC equipment. Significantly less perceived preparedness was reported in lower-middle income (LMICs) (B = −1.31, p = 0.006) and upper-middle income (UMICs) (B = −0.98, p = 0.02) countries than in high-income countries (HICs), in teaching only (B = −0.55, p &lt; 0.0001) and in research only (B = −1.22, p = 0.003) than teaching and research institutions and in institutions receiving ≤100 patients daily than those receiving &gt;100 patients (B = −0.38, p &lt; 0.0001). More perceived preparedness was reported by academics with administrative roles (B = 0.59, p &lt; 0.0001). Academics from low-income countries (LICs) and LMICs reported less availability of clinic apparel, IPC equipment, measures before patient care, and institutional policies but more measures during patient care. There was greater perceived preparedness in HICs and institutions with greater involvement in teaching, research, and patient care

Knowledge of dental academics about the COVID-19 pandemic: a multi-country online survey

Background: COVID-19 is a global pandemic affecting all aspects of life in all countries. We assessed COVID-19 knowledge and associated factors among dental academics in 26 countries. Methods: We invited dental academics to participate in a cross-sectional, multi-country, online survey from March to April 2020. The survey collected data on knowledge of COVID-19 regarding the mode of transmission, symptoms, diagnosis, treatment, protection, and dental treatment precautions as well as participants’ background variables. Multilevel linear models were used to assess the association between dental academics’ knowledge of COVID-19 and individual level (personal and professional) and country-level (number of COVID-19 cases/ million population) factors accounting for random variation among countries. Results: Two thousand forty-five academics participated in the survey (response rate 14.3%, with 54.7% female and 67% younger than 46 years of age). The mean (SD) knowledge percent score was 73.2 (11.2) %, and the score of knowledge of symptoms was significantly lower than the score of knowledge of diagnostic methods (53.1 and 85.4%, P &lt; 0.0001). Knowledge score was significantly higher among those living with a partner/spouse than among those living alone (regression coefficient (B) = 0.48); higher among those with PhD degrees than among those with Bachelor of Dental Science degrees (B = 0.48); higher among those seeing 21 to 30 patients daily than among those seeing no patients (B = 0.65); and higher among those from countries with a higher number of COVID-19 cases/million population (B = 0.0007). Conclusions: Dental academics had poorer knowledge of COVID-19 symptoms than of COVID-19 diagnostic methods. Living arrangements, academic degrees, patient load, and magnitude of the epidemic in the country were associated with COVD-19 knowledge among dental academics. Training of dental academics on COVID-19 can be designed using these findings to recruit those with the greatest need

Knowledge of dental academics about the COVID-19 pandemic: a multi-country online survey.

BACKGROUND: COVID-19 is a global pandemic affecting all aspects of life in all countries. We assessed COVID-19 knowledge and associated factors among dental academics in 26 countries. METHODS: We invited dental academics to participate in a cross-sectional, multi-country, online survey from March to April 2020. The survey collected data on knowledge of COVID-19 regarding the mode of transmission, symptoms, diagnosis, treatment, protection, and dental treatment precautions as well as participants' background variables. Multilevel linear models were used to assess the association between dental academics' knowledge of COVID-19 and individual level (personal and professional) and country-level (number of COVID-19 cases/ million population) factors accounting for random variation among countries. RESULTS: Two thousand forty-five academics participated in the survey (response rate 14.3%, with 54.7% female and 67% younger than 46 years of age). The mean (SD) knowledge percent score was 73.2 (11.2) %, and the score of knowledge of symptoms was significantly lower than the score of knowledge of diagnostic methods (53.1 and 85.4%, P <  0.0001). Knowledge score was significantly higher among those living with a partner/spouse than among those living alone (regression coefficient (B) = 0.48); higher among those with PhD degrees than among those with Bachelor of Dental Science degrees (B = 0.48); higher among those seeing 21 to 30 patients daily than among those seeing no patients (B = 0.65); and higher among those from countries with a higher number of COVID-19 cases/million population (B = 0.0007). CONCLUSIONS: Dental academics had poorer knowledge of COVID-19 symptoms than of COVID-19 diagnostic methods. Living arrangements, academic degrees, patient load, and magnitude of the epidemic in the country were associated with COVD-19 knowledge among dental academics. Training of dental academics on COVID-19 can be designed using these findings to recruit those with the greatest need