Protocol Analysis Research Articles

Lacticaseibacillus rhamnosus LRa05 in the treatment of acute diarrhea in children: a randomized controlled trial

IntroductionThe goal of this study is to assess the efficacy and safety of Lacticaseibacillus rhamnosus LRa05, as an adjunct to the treatment of acute watery diarrhea in children.MethodsEligible diarrheal children were randomized into intervention group (IG, n = 57) and control group (CG, n = 54), and given probiotics or placebo, respectively.ResultsThe total duration of diarrhea in the IG (121.4 ± 13.7 h) was significantly shorter than that in the CG (143.9 ± 19.8 h, p < 0.001). More children in the IG showed improvements in diarrhea than those in the CG for both per protocol analysis (70.2 vs. 46.3%, p = 0.01) and intention-to-treat analysis (66.7 vs. 41.7%, p = 0.003). The LL-37 levels in the IG was markedly higher than that in the CG after the intervention (4349.35 ± 1143.86 pg./g vs. 3682.49 ± 869.21 pg./g, p = 0.039). The intervention led to higher abundance of Bifidobacterium longum and lower abundance of Enterococcus faecium, Lactobacillus rhamnosus, and Bacteroides fragilis (p < 0.05). LRa05 treatment upregulated the functional genes of gut microbiota involving immunity regulation.DiscussionAdministration of the Lacticaseibacillus rhamnosus LRa05 at a dose of 5 × 109 CFU/day to children aged 0-3 years resulted in shorter duration of diarrhea, faster improvement in fecal consistency, and beneficial changes in gut microbiome composition and gene functions.Clinical trial registrationThe present study has been approved and registered in the Chinese Clinical Trial Registration Center with the registration number of ChiCTR2100053700 (https://www.chictr.org.cn/showproj.html?proj=141082).

Secure Search of Smart Home Data Based on Access Control Encryption

Abstract: In recent years, the increasing variety of smart home devices, such as smart locks, surveillance cameras, and various sensors, has led to a significant rise in related data. To facilitate the sharing of smart home data, manufacturers store these data on the Internet of Things (IoT). However, since IoT servers are not fully trustworthy and the data often contain sensitive commercial information, any leakage could result in a commercial crisis for manufacturers. To address security concerns, manufacturers encrypt the data before storing them on the IoT. A challenge arises: how can users search for target data in encrypted form? This paper proposes a new search encryption scheme for smart home data, addressing the limitations of existing attribute-based encryption (ABE) searchable encryption schemes. The proposed scheme integrates access control trees and bilinear mapping technology, supporting multiple access policies including AND gates, OR gates, and threshold gates. Experimental results demonstrate a comprehensive analysis of the attribute-based searchable encryption protocol under a multi-authority architecture, covering four dimensions: correctness, security, complexity, and real-world application scenarios. In specific scenarios, when a data user, out of privacy concerns, is unwilling to reveal all attribute information to a single authority during a query for shared datathus avoiding identity disclosureor when the users identity information is managed by multiple independent authorities, this protocol proves highly effective. It ensures smooth data sharing while maintaining data security for both data owners and users, fully safeguarding data privacy and shareability.

Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, Canada

The Canadian province of Nova Scotia recently became the first North American jurisdiction to implement deemed consent for deceased organ donation as part of a comprehensive legislative reform of their donation and transplantation system. This study will examine the performance metrics and effectiveness of this policy in comparison with other Canadian provinces via a natural experiment evaluation. We will use a cross-sectional controlled interrupted time series quasi-experimental design. Our primary outcome will be consent for deceased donation as confirmed at the time of eligibility (prior registered intent to donate will be noted but not be considered positive unless affirmed at the time of eligibility). Secondary outcomes will include identification and referral of patients who are potential donors, rates of family override of previously registered intent to donate, and donation and transplantation rates per million population. Data will be collected from potential donor audits in Nova Scotia and 3 control provinces (provinces in Canada without deemed consent policies). Study outcomes will be compared in Nova Scotia relative to control provinces in the 3 y before and 3 y after the implementation of legislative reform. These provinces were selected as having systems resembling those of Nova Scotia but without deemed consent.Using controlled interrupted time series methodology compared with other Canadian provinces with otherwise similar systems, we aim to isolate the impact of the deemed consent aspect of legislative reform in Nova Scotia using a robust natural experiment evaluation design as much as possible. Careful selection of outcome measures will allow donation and transplantation stakeholders to properly evaluate if similar reforms should be considered in their jurisdictions.

A multicenter, cross-sectional analysis to assess the safety and usage pattern of brivaracetam in the management of partial-onset seizure with BAEs-BREEZE study: A post-hoc analysis.

Brivaracetam (BRV), a third-generation anti-seizure medication (ASM) offers strong conformational receptor domain binding, faster blood brain barrier (BBB) permeability and better tolerability making it potential therapeutic option as an initial line or initial line add-on strategy for focal onset seizure (FoS). The following study was planned to further understand the role and relevance of BRV in the real world settings of India. This was a multicentric, cross-sectional, and non-interventional study conducted in patients with FoS across India. The study was approved by central independent ethics committee. Descriptive and analytical statistics employed using SPSS version 29.0.1.0. Per protocol (PP) analysis included 8479 eligible patients from 1069 sites, gender; 5771 (68.06%) male and 2708 (31.94%) female with mean age 41.21 ± 12.74 years. Total 8019 (94.57%) patients had FoS and 460 (5.43%) patients had focal to bilateral tonic-clonic seizures (FBTCs). In FoS, 4105 (51.19%) patients switched from LEV to BRV whereas 3914 (48.81%) switched from other ASMs to BRV. BAEs accounted for 2059 (50.16%) patients in LEV to BRV switch versus 133 (3.39%) in other ASM to BRV switch. Post switch, LEV-associated BAEs reduced irrespective of being used as monotherapy 85.65% (p < 0.001) or as an adjuvant therapy 83.71% (p < 0.001) at BRV dosage of 50 to 100 mg BID. This RWE showed the utility of BRV as mono component as an initial add-on strategy in FoS cases. BRV remains a pertinent therapeutic choice for FoS for the treatment naïve and/or BAE cases. Exposure of LEV leads to considerable BAEs compared to patients without LEV exposure. Patients who switched to BRV due to LEV-induced BAEs significantly improved tolerability with BRV irrespective being used as monotherapy or as adjuvant therapy. Current study was planned to understand the clinical role and relevance of third-generation anti-seizure medication (ASM), brivaracetam (BRV) in the real world settings of India. Outcome of the study highlighted that BRV is an emerging, potential and safe ASM treatment option for epilepsy in Indian context. Many patients with epilepsy who are not able to tolerate the other ASM including levetiracetam (LEV) primarily due to behavioral side effects improves tolerability post switch to BRV, additionally results are consistent either BRV being used as an adjuvant therapy or as monotherapy therapy.

Preliminary results from a multicenter, randomized trial using fecal microbial transplantation to induce remission in patients with mild to moderate Crohn's disease.

Fecal microbial transplantation (FMT) has shown promise at inducing remission in ulcerative colitis. This study is the first of its kind to evaluate the efficacy and safety of FMT at inducing remission in Crohn's disease (CD). This double-blind, placebo-controlled trial was conducted in three Canadian academic centers; randomized patients with mild to moderate CD received FMT or placebo. The first treatment was administered by colonoscopy followed by weekly fecal capsules for 7 weeks. Primary endpoint was clinical and endoscopic remission at week 8. Secondary outcomes included clinical and endoscopic response, adverse events, and health-related quality of life using generic and disease-specific instruments. From July 2017 to June 2021, 21 and 13 patients were randomized to FMT and placebo groups, respectively. The trial terminated early due to futility. At week 8, 0% (0/15) of patients in the FMT group versus 8.3% (1/11) in the placebo group reached the primary endpoint of combined clinical and endoscopic remission as per protocol analysis. There were no differences between the groups in clinical or endoscopic responses. One participant in each group had worsening of CD. Although both groups experienced statistically significant improvements in health-related quality of life, only the FMT group had a significant decrease in activity impairment. Although there were no significant changes in microbial diversity or composition, participants who achieved clinical response became more similar to their donors in stool microbial composition. FMT was not effective at inducing clinical and endoscopic remission in CD using the FMT regimen in this study. Future studies may use other strategies to enhance treatment response, including longer intervention, antibiotic pretreatment, optimized donor-recipient pairing, and concomitant anti-inflammatory diet, biologic or small molecule therapies.

Medicines shortages in the UK: review of the causes and analysis of serious shortage protocols – a mixed methods study

Abstract Introduction Causes of medicines shortages are multifactorial. In February 2019, the Human Medicines Regulations 2012 introduced Serious Shortage Protocols (SSPs) to address medicines shortages. SSPs are issued by the Department of Health and Social Care and enable pharmacists to supply alternative medicines without amended prescriptions1. Aim This review aimed to explore contemporary reasons attributed to medicines shortages in the United Kingdom (UK) and analyse expired SSP records. Methods A rapid scoping literature review was conducted using National Library of Medicine (PubMed®) and Elsevier (ScienceDirect). Grey literatures were collated from the Pharmaceutical Journal, Google, and Public Health England’s grey literature index. Searches were limited to publications written in English, published since 2014, which met the inclusion criteria (medicines OR drugs AND shortages AND causes). Data extraction and analysis was performed using Microsoft Excel. Expired SSPs were extracted to Microsoft Excel and analysed using descriptive and inferential statistics on R software (v.4.3.2). SSP data is publicly available; therefore, no ethical approval was required. Results Causes of Medication Shortages A total of 11 papers were selected, in which 77 medicines shortage causes were discussed. Narrative analysis identified 10 shortage-drivers. The most frequent were Manufacturing and Quality Challenges (30%,23/77), Business and Commercial Issues (21%,16/77), and Regulatory Changes and Challenges (10%,8/77). Content analysis found that supply-driven issues were more frequently cited than demand-driven issues. SSP Analysis Between October 2019 and June 2024, 59 SSPs had expired2. Menopausal Hormonal Treatments (MHTs) were the most common medication class in shortage (41%,24/59), followed by antibiotics (17%,10/59), and antidepressants (12%,7/59). The mean shortage length was 129.2 days (IQR=51–196), the longest lasting 359 days (oestradiol 0.5mg/1mg gel sachets). Oestradiol transdermal medications accounted for 19 of 24 MHT SSPs. The mean MHT shortage length was 152.6 days (IQR=51.0–216.0). Phenoxymethylpenicillin accounted for 8 of 10 antibiotic shortages. All 8 phenoxymethylpenicillin SSPs were active from 15 December 2022 to 12 May 2023; 7 of 8 were oral solution formulations. The mean antibiotic shortage length was 168.8 days, which is significantly longer than the whole sample average (p&amp;lt;0.05, IQR=147.0–148.0). All antidepressant SSPs were fluoxetine capsules. The mean shortage length was 99 days (IQR= 35.5–122.0). Discussion Existing literature suggests supply-driven rather than demand-driven causes of medication shortages are more pertinent; however, most expired SSPs were issued in response to demand-driven factors, such as disease outbreaks and changing prescribing demand. This suggests the extent of demand-driven shortages is not reflected in current literature. Future research should explore how demand-driven causes of shortages can be mitigated. As a rapid scoping review was conducted, the full breadth of literature may not be presented. Additionally, the grey literature findings are limited by potential inaccuracies. Finally, the use of narrative analysis may limit the generalisability of identified shortage drivers. As of 05 June 2024, there are 5 active SSPs. With medicines shortages becoming normalised within the UK health system3, there is an urgent need to mitigate supply- and demand-driven causes. Additionally, further research should explore why certain medication classes are more frequently in shortage than others.

Laki niin kuin se luetaan – säädöskielen käytettävyyttä tutkimassa

The article looks at how readers understand legal text, which characteristics cause difficulties, and which facilitate understanding. The method used is protocol analysis. It examines a subject’s reading process, highlighting the features that affect reading and understanding. Subjects read test texts while verbalizing their reading experience, and their thinking aloud is recorded, transcribed, and analyzed. Subjects include lawyers, officials, and laypeople, and test materials contain extracts from the Finnish Inheritance Code, the Income Tax Act, and the Working Time Act. The results show the impact of different textual elements on comprehension and usability.

Experience in the Examination of Bioequivalence Clinical Trials of Locally Applied and Locally Acting Medicinal Products in Accordance with the Eurasian Economic Union Procedures

INTRODUCTION. The examination of protocols for clinical trials of locally applied and locally acting medicinal products highlights challenges that developers face when selecting the design, endpoints, population, comparison groups, and sample size. An analysis of the most common errors in clinical trial protocols will help minimise the number of comments from protocol reviewers and accelerate the process of bringing novel medicinal products to the pharmaceutical market.AIM. This study aimed to analyse the results of evaluating clinical trials of locally applied and locally acting medicinal products conducted with due consideration of the recent additions to the Rules for Conducting Bioequivalence Studies of Medicinal Products within the Eurasian Economic Union (EAEU); assess the main advantages of the added requirements and the challenges remaining in protocol development; and make recommendations for the most effective application of existing laws and regulations.DISCUSSION. The Rules for Conducting Bioequivalence Studies of Medicinal Products within the EAEU were supplemented with Appendices 11, 12, and 13 in August 2023. Since then, protocol reviewers have accumulated sufficient experience in the examination of clinical trial protocols for locally applied and locally acting medicinal products. This article presents the most frequent comments made during the examination of clinical trial protocols and provides recommendations for corrective actions. The most challenging aspects of drafting a protocol for a clinical trial of a locally applied and locally acting medicinal product include the selection and justification of primary/secondary endpoints and the calculation and justification of the population size. The difficulty is probably due to the lack of a detailed description of study characteristics in EAEU laws and regulations. Locally applied and locally acting corticosteroids are the least challenging medicinal products in terms of protocol drafting because EAEU legislation and scientific publications provide the most detailed guidance for them.CONCLUSIONS. The analysis of protocols for clinical trials of locally applied and locally acting medicinal products, relevant EAEU requirements, and applicable international guidelines identified several major challenges, including the selection of primary/secondary endpoints, the characterisation of the trial population, and the justification of the sample size. The recommendations presented in this article will help applicants in planning clinical trials aimed at accelerating the launch of medicinal products into the pharmaceutical market.

Аналіз змагальної діяльності юних спортсменів на 38-му дитячому турнірі «Ванпаку сумо»

Purpose: to analyze the competitive activity of young athletes at the 38th «Wanpaku Sumo» Children's Tournament. Material and methods. The following methods were used in the study: analysis of scientific and methodological information and Internet sources; generalization of best practices; analysis of protocols and video recordings of matches. A total of 293 fights were analyzed (92 fights among fourth graders, 94 among fifth graders, 107 among sixth graders). For the analysis, a specialized computer program «Martial Arts Video Analysis» was used. Results: the analysis of competitive activity allowed us to identify the groups of techniques most often used by athletes during competitions. The most frequently used techniques of the group kihon waza (57,65 %). Athletes of all age groups actively used the basic technique (4th grade – 57,60%, 5th grade – 57,44 %, 6th grade – 57,94 %). The most common techniques in all age categories were yorikiri and oshidashi. Actions that occurred during the competition and belong to the hiwaza group and are not kimarite indicate that young athletes do not yet have perfect control over their bodies and can lose balance even without the intervention of an opponent. The analysis of technical actions allowed us to observe the progress of technique by grade. Thus, in the fifth grade, more complex techniques (harimanage and chongake) appear. This indicates that children are gradually mastering more complex techniques that require better coordination and tactical thinking. In the upper grades, the use of complex techniques such as tsukiotoshi and sotogake is observed. This indicates that participants are becoming physically stronger and more coordinated, which indicates a gradual mastery of more complex techniques. Conclusions. The analysis of the competition during the 38th «Wampaku Sumo» Tournament revealed some characteristic features. First, the competitions were highly intense. The yorikiri technique is the most effective, so it is very popular among young athletes. Although yorikiri dominates, the presence of other techniques such as koshinage and makiotoshi shows that participants have a diverse arsenal of techniques. In high school, participants begin to demonstrate better physical fitness, which helps them to use more complex techniques and endure bouts longer. Psychological pressure also plays a role, as participants are forced to make quick decisions and choose techniques that are most effective under pressure.

Вікові особливості олімпійських чемпіонів в спортивній боротьбі

Purpose: determine the age characteristics of Olympic champions in three styles of sports wrestling (Greco-Roman, freestyle and women's). Material and methods. The age of Olympic champions from 1896 to 2024 in three styles of sports wrestling: Greco-Roman (29 Olympiads), freestyle (27 Olympiads) and women's (6 Olympiads) was studied. A total of 455 athletes were analyzed: Greco-Roman (n=214), freestyle (n=211) and women's (n=30). The raw data of the wrestlers' performances is taken from the UWW website. The research used the following methods: analysis of scientific and methodological information and Internet sources; analysis of competitive activity protocols; methods of mathematical statistics. Results: the analysis of the age characteristics of Olympic champions during the research period showed that in Greco-Roman wrestling, the average age of athletes varies from 24,1 years to 32,8 years; in freestyle wrestling - from 23,0 years to 29,6 years; in women's wrestling - from 20,3 years to 27,5 years. The youngest champion in Greco-Roman wrestling was 18 years and 8 months, and the oldest was 41 years and 11 months. The youngest freestyle champion was 19 years and 8 months, and the oldest was 40 years and 4 months. In women's wrestling, the youngest and oldest champion was the same wrestler who took part in four Olympics and won four gold medals. She was 18 years and 2 months old at the first Olympics, and 32 years old at the fourth. The most decorated wrestler is Cuban heavyweight Mijain Lopez, who participated in six Olympic Games and won five gold medals. Seven stages of the evolutionary development of wrestling were identified. The youngest average age is observed among athletes at the first stage both in Greco-Roman wrestling (25,39 years) and in freestyle wrestling (23,92 years). The greatest average age of the athletes was at the second stage in the Greco-Roman style (29,36 years) and freestyle (27,52 years) wrestlers. Women's wrestling has been included in the program of the Olympic Games since 2004, so it is only in the last two stages. The average age of the wrinkles does not have a significant difference at these stages. It should be noted that at the last stage, Greco-Roman wrestlers have an average age of almost four years more than representatives of freestyle and women's wrestling. Conclusions. The conducted research made it possible to determine the age characteristics of Olympic champions in three styles of sports wrestling. The results of the study showed that the athletes competed in a wide age range (18-42 years), the average age was 27,82±9,77 years. The majority of athletes were between 22 and 32 years old, which accounted for 80 % of the total number. It was established that in Greco-Roman wrestling, the average age of athletes of all Olympiads is significantly higher (p&lt;0,05) than in freestyle and women's wrestling. It was found that women were younger than men. There was also a weight category effect, with lighter wrestlers being younger than heavier wrestlers.

Prediction of intracranial electric field strength and analysis of treatment protocols in tumor electric field therapy targeting gliomas of the brain

Prediction of intracranial electric field strength and analysis of treatment protocols in tumor electric field therapy targeting gliomas of the brain

Implementation and Analysis of EMQX broker for MQTT Protocol in the Internet of Things

A low-cost monitoring and data transfer system is needed that uses various protocols in the Internet of Things (IoT) technologies. Among the various available protocols for the transmission of messages such as hypertext transfer protocol (HTTP), constrained application protocol (CoAP), etc., message queuing telemetry transport (MQTT) is the most widely used protocol due to its lower power consumption. Further, broker selection is the foremost task in operating the MQTT-based algorithms used in the automation. Researchers have explored several brokers. After a rigorous analysis, the EMQX broker-based MQTT protocol is investigated to transfer the data between the clients efficiently. The implementation and performance analysis of the EMQX broker-based MQTT protocol is assessed in depth with respect to the published and subscribed rates of data packets. Furthermore, new metric sets i.e. average number of messages published and subscribed and messages received with actual QoS are represented and analyzed in combinations of different quality of services (QoSs) to publish and subscribe the data. The analysis shows the efficacy of the investigated protocol.

Metoprolol therapy in patients with Eisenmenger syndrome (MINES) study. A single-centre, double-blinded, randomised, placebo-controlled trial

Abstract Background Prevalence of Eisenmenger syndrome is still common in developing countries where early neonatal screening and referral for surgery is seldom possible. Limited number of drugs are available for treatment of this condition. Beta-blockers may improve functional status in these patients. Observational study has shown beta blockers to be safe and effective in improving effort intolerance in patients with Eisenmenger syndrome. Purpose To study the safety and efficacy of metoprolol succinate therapy in patients with Eisenmenger syndrome. Methods In this double-blind, placebo-controlled study, we randomly assigned 60 patients with Eisenmenger syndrome to receive placebo or to receive 25 mg of metoprolol succinate once daily for 2 weeks followed by 25 mg twice daily for 14 weeks (total of 16 weeks). The primary outcome was mean difference in 6-minute walk test (6MWT) distance. Secondary outcomes were clinical composite outcome (all-cause death, heart failure hospitalization, worsening of heart failure, change in WHO functional class, and new onset syncope), change in resting saturation, Tricuspid Annular Plane Systolic Excursion (TAPSE) and NT Pro BNP level at 16 weeks. Results At 16 weeks, the mean difference in 6MWT distance between treatment group and placebo group as per protocol analysis was 6 meters (95% confidence interval, - 7.43 to 19.49; P 0.37), and the mean difference in 6MWT distance as per intention to treat analysis was -1.1 meters (95% confidence interval, - 16.97 to 14.77; P 0.89). Clinical composite outcome occurred more in the treatment group 5(17%) as compared to the placebo group 1(3%) (P 0.197) though it did not reach statistical significance. This was primarily driven by worsening of heart failure in the treatment group. Compared to baseline metoprolol group had 37% increase in NT pro BNP level while placebo group had 13% (-313.69, 88.80) reduction in NT Pro BNP level. There was no difference in TAPSE 0.05 (95% confidence interval -0.62 to 0.72; P 0.88) or resting saturation -0.06 (95% confidence interval -0.88 to 0.75; P 0.87) between the two groups at 16 weeks Conclusion Metoprolol succinate therapy did not improve 6-minute walk distance at 16 weeks among patients with Eisenmenger syndrome compared to placebo. Metoprolol succinate therapy was associated with increased clinical composite outcomes, primarily driven by worsening of heart failure.Graphic Abstract of MINES study

Environmental impact analysis of ajmaline challenge protocols: a comparative assessment of carbon footprint reduction in Brugada Syndrome diagnosis

Abstract Background Climate change is an urgent public health crisis that significantly impacts disease development and health outcomes. The 2022 Lancet Countdown Report revealed that healthcare contributes with 5.2% of global emissions, prompting a call for environmentally conscious approaches. In this context, we explored the environmental impact of different ajmaline challenge protocols, aiming to contribute to a more sustainable medical landscape. Purpose This study aims to compare the carbon footprint of two ajmaline challenge protocols commonly used in diagnosing Brugada syndrome, an inherited cardiac disorder associated with sudden cardiac death. Methods We performed a retrospective and observational analysis of adult patients (pts) who underwent ajmaline testing between March 2020 and June 2023 in two hospitals. In Group A (infusion protocol), 1mg/kg of ajmaline diluted in 50 mL of 5% glucose solution was infused in 10 minutes, up to the target dose, until a positive result or termination criteria ensued. In Group B (bolus protocol), 10 mg of ajmaline were administered every 2 minutes, again up to the target dose of 1mg/kg (maximum of 100 mg) or test interruption was indicated. Greenhouse gas emissions resulting from material processing were estimated based on life cycle analyses of each product's composition. Material consumption, waste production, and direct measurement of weights were considered. Results A total of 101 pts were included, 49 pts in group A with a mean age of 47.3±14.3 years old and 52 patients in group B with a mean age of 43.9±16.6 years-old. No complications were observed in either group. Test performance was not evaluated, since both protocols have been previously validated. Group A, utilizing the infusion method, exhibited a higher environmental impact, producing 18.19 kg CO2eq, compared to 6.23 kg CO2eq (p&amp;lt;0.001) in Group B (bolus protocol). Group B not only demonstrated a 66% reduction in CO2eq emissions but also used significantly less plastic (16g vs 102g per test) and glass (1.58 kg vs 1,79Kg), emphasizing its environmental superiority. Conclusions Shifting from infusion to bolus in ajmaline challenge protocols results in a substantial reduction in carbon footprint. Our findings emphasize the potential impact of adopting more dematerialized approaches in cardiac testing, urging healthcare professionals to embrace sustainable practices. Despite the study's limited sample size, the global adoption of such environmentally friendly strategies promises significant positive effects on healthcare's environmental footprint.

Security analysis and provision of authentication protocol, based on peer-to-peer structure in IOT platform

The Internet of Things technology allows you to transfer data to any asset through communication networks such as the Internet or intranet. One of the most important problems is security, which includes confidentiality, authenticity validation, and completeness. Among security problems, the most important ones are ensuring authenticity and protecting privacy. The elliptic curve encryption algorithm is famous protocols for maintaining privacy and verifying authenticity. Despite the capabilities they have and provide good security against network attacks, they face challenges such as response time, delay in the authentication and authentication process, as well as the amount of memory consumed. Two-factor authentication (2FA) is a security process where users provide two different authentication factors to authenticate themselves. It also provides a higher level of security than authentication methods that rely on single-factor authentication (SFA). This article presents two novel methods for 2FA that use encryption techniques, scramble architecture, and chord architecture. These methods allow for the authentication process to be initiated by both parties involved in the communication. Three scenarios and three metrics of reaction time, memory usage, and connection latency were used to assess the efficacy of the suggested approach. The average reaction time is improved and is 0.012 s when the lengths of the finger table in the chord structure are increased to 10, 15, and 20. The findings show that the suggested approach reduces computing complexity, reaction time, and communication latency. It has an average reaction time of 0.016 s, an average memory use of 30,360 kb, and an average connection latency of 0.042 s.

PRevention Intervention and Support in Mental health for people with aphasia (Aphasia PRISM): protocol and mixed methods analysis plan for two feasibility studies

BackgroundPeople with aphasia commonly experience depression and anxiety. The individual therapy program, Aphasia PRevention Intervention and Support in Mental health (Aphasia PRISM) offers low intensity psychotherapeutic interventions using communication supports. Trained stroke clinicians from disciplines other than psychology (e.g., allied health professional, nurse, doctor) can deliver such interventions. The aim of the planned studies is to test the acceptability, feasibility and preliminary effectiveness of Aphasia PRISM for preventing depression and anxiety and supporting wellbeing in people with aphasia after stroke.MethodThis protocol describes two feasibility studies of the Aphasia PRISM using parallel, convergent, mixed methods designs. Participants will be adults with aphasia after stroke from a metropolitan healthcare site (Study A, pre-post case series, approximate n = 6) and two regional/rural sites (Study B, randomised controlled trial, n = 30; random allocation to either: treatment arm Aphasia PRISM + usual care; or attention control of secondary stroke prevention information + usual care) in Victoria, Australia. Eligible participants will be offered 7 weekly intervention sessions (via telehealth or in person). Other participant groups include stroke clinicians / site managers and family members. Feasibility will be assessed with treatment acceptability ratings (primary outcome) and secondary outcomes such as recruitment rate and participant clinical response. Participant clinical responses to intervention will be collected pre-intervention (baseline), concurrently (4 week acceptability measure), immediately post (8 weeks), follow-up (3 months) and follow-up at 6 months (Study B only). Descriptive statistics will be used to analyse quantitative data based on the type and distribution of data. Reflexive thematic analysis, an inductive approach will be used to analyse qualitative data.DiscussionAphasia PRISM offers the potential for trained stroke clinicians to deliver low intensity psychotherapeutic interventions with communication supports to people with aphasia. Studies A and B were registered with the Australian New Zealand Clinical Trials registry under one registration (ACTRN12620000209998) 20th February 2020.

De- and recoding algorithmic systems: The case of fact checkers and fact checked users

With the recent development of debunking on social media as a dominant agenda, fact checkers have increasingly used machine learning (ML) to identify, verify and correct factual claims, as ML promises the scaling of fact checking practices. However, it also places a new actor in between the fact checkers and the fact checked users. In this paper, we conducted a contrasted analysis of how fact checkers and fact checked users understand, evaluate and act towards the algorithmic system and the data flows in Meta’s Third-Party Fact-Checking Program: We did ethnographic fieldwork in the fact checking newsroom and interviewed and did protocol analysis with the fact checked. For both professional users and end users, the algorithmic system is experienced as a black box in which they have limited insight, and their sense-making practices happen based on the data and metrics that are made visible to them. In the paper, we draw on and expanded theory on decoding algorithms by not only exploring how the two user groups engage in decoding the algorithmic system, but also actively engage in forms of recoding by attempting to adapt or modify the algorithmic system to better fit within their cultural and social context, which is characterised by both varying epistemic cultures and societal positions. While the fact checkers from their hegemonic (sometimes negotiated) position understand the program as a (sometimes stupid) tool and primarily engage in passive acts of recoding, fact checked users, from their oppositional position, understand the program as an unpredictable censoring machine and engage primarily in more active acts of recoding. Based on the analysis, we end the paper with a discussion in which we argued for understanding data reflexivity as highly relational and processual.

Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial

Multiple sclerosis is an inflammatory demyelinating disease and represents a global health concern. Ocrelizumab, a humanized IgG monoclonal antibody, selectively targets CD20 on B cells and CD20-expressing T cells. This study aimed to compare the efficacy and safety of the biosimilar ocrelizumab candidate (Xacrel) to the originator product (Ocrevus) in Relapsing Multiple Sclerosis (RMS) patients. In this randomized trial, patients received either Xacrel or Ocrevus for 96 weeks. The primary endpoint was the equivalency of the medications in reducing the annualized relapse rate (ARR) at week 48. The secondary endpoints included time to the onset of disability progression confirmed at 12 and 24 weeks, the proportion of relapse-free patients, magnetic resonance imaging (MRI) evaluations, safety assessments, and immunogenicity over 96 weeks. A total of 170 patients were randomized (1:1 ratio). In the per protocol analysis, the upper and lower limits of 95% two-sided confidence intervals of difference between treatments in the 48-week ARR rate were in the predefined margin of − 0.2 to 0.2 (− 0.002; 95% CI − 0.080 to 0.075). The two products were also comparable in terms of other efficacy parameters, safety, and immunogenicity. The results confirmed that Xacrel is equivalent to Ocrevus in terms of 48-week ARR in RMS patients, with no considerable difference in other efficacy parameters and the safety profile during the 96 weeks. The trial was registered in Iranian registry of clinical trials (IRCT) on 10/06/2019 with the registration number of IRCT20150303021315N13 and in Clinicaltrials.gov on 19/07/2021 with the registration code of NCT04966338.

The Canadian platform for research online to investigate health, quality of life, cognition, behaviour, function, and caregiving in aging (CAN-PROTECT): Study protocol, platform description, and preliminary analyses

Background: Preventing or reducing the risk of cognitive decline and dementia is of great public health interest. Longitudinal data from diverse samples are needed to properly inform clinicians, researchers, and policy makers. CAN-PROTECT is a recently launched online observational cohort study that assesses factors contributing to both risk for incident cognitive decline and dementia and resilience against brain aging, in participants across the lifespan. Methods: Measures of cognition, behaviour, and quality of life administered to both participants and study partners were compared using partial Spearman correlations adjusted for participant and study partner age, sex, and education. In participants, relationships between cognition, behaviour, function, and quality of life were examined using adjusted multivariable linear and negative binomial regression models. Results: In the first three-month window, 2150 participants spanning all Canadian provinces enrolled; 637 nominated study partners had already completed assessments. Engagement with the study was excellent, with many optional assessments completed. Initial analyses demonstrated relationships between cognition, behaviour, function, and quality of life. Discussion: These preliminary results speak to the utility and feasibility of CAN-PROTECT to obtain data relevant to brain health, highlighting the public interest in participating in studies on cognition. The online portal facilitated participation of a geographically diverse sample. This group is ideal to study brain aging, dementia prevention, and early detection of neurodegenerative disease. Longitudinal data will provide additional insights. Several features of CAN-PROTECT are important to consider in terms of assessing risk and resilience in Canadians, and for further development and recruitment of a research-ready cohort.

Exploring the potential of artificial intelligence models for triage in the emergency department

ABSTRACT Objective To perform a comparative analysis of the three-level triage protocol conducted by triage nurses and emergency medicine doctors with the use of ChatGPT, Gemini, and Pi, which are recognized artificial intelligence (AI) models widely used in the daily life Materials and methods The study was prospectively conducted with patients presenting to the emergency department of a tertiary care hospital from 1 April 2024, to 7 April 2024. Among the patients who presented to the emergency department over this period, data pertaining to their primary complaints, arterial blood pressure values, heart rates, peripheral oxygen saturation values measured by pulse oximetry, body temperature values, age, and gender characteristics were analyzed. The triage categories determined by triage nurses, the abovementioned AI chatbots, and emergency medicine doctors were compared. Results The study included 500 patients, of whom 23.8% were categorized identically by all triage evaluators. Compared to the triage conducted by emergency medicine doctors, triage nurses overtriaged 6.4% of the patients and undertriaged 3.1% of the yellow-coded patients and 3.4% of the red-coded patients. Of the AI chatbots, ChatGPT exhibited the closest triage approximation to that of emergency medicine doctors; however, its undertriage rates were 26.5% for yellow-coded patients and 42.6% for red-coded patients. Conclusion The undertriage rates observed in AI models were considerably high. Hence, it does not yet seem appropriate to solely rely on the specified AI models for triage purposes in the emergency department.