IntroductionSecondary lower extremity lymphoedema is a chronic progressive condition that frequently develops after cancer treatment and results in persistent swelling, recurrent cellulitis and impaired quality of life. Lymphaticovenous anastomosis (LVA) is an established physiological microsurgical treatment; however, postoperative outcomes vary and evidence-based adjunctive postoperative management remains limited. A novel pneumatic lymphatic drainage (PLD) system has been developed to deliver anatomically directed, pathway-aligned mechanical stimulation that mimics manual lymphatic drainage. Its clinical efficacy following LVA has not yet been evaluated in a randomised controlled trial.Methods and analysisThis multicentre, open-label, parallel-group randomised controlled trial will enrol adults (≥18 years) with unilateral secondary lower extremity lymphoedema (International Society of Lymphology stage I–II) undergoing LVA. Participants will be randomised 1:1 to receive PLD plus standard postoperative care or standard postoperative care alone. PLD will be initiated on the day of surgery and continue for 6 months (Day 183). The primary outcome is the rate of improvement in excess limb volume (EV) at Day 183 relative to baseline, calculated from circumferential measurements taken at 4 cm intervals using the truncated cone method, with the contralateral limb serving as an internal control. Secondary outcomes include longitudinal trajectories of EV, improvement in excess limb fluid volume assessed by bioimpedance, the Lymphedema Quality of Life Questionnaire, cellulitis incidence and safety outcomes. A total of 64 participants (32 per group) will provide 80% power (two-sided α=0.05) to detect a 15-percentage-point between-group difference in the rate of improvement in EV at 6 months, assuming a common SD of 20 percentage points and allowing for attrition. Primary analyses will follow the ITT principle using mixed-effects models for repeated measures.Ethics and disseminationThe study was approved by the Chiba University Certified Review Board (approval number: CRB0119-25; approval date: 15 December 2025) and was conducted in accordance with the Declaration of Helsinki and the Japanese Clinical Trials Act. Results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences, irrespective of study outcomes.Trial registrationjRCTs032250600.

Suicidal ideation is common in young people and increases the risk of suicide. Effective interventions that are relevant and accessible to young people, so-called digital natives, are urgently required. There are key questions regarding the cross-cultural efficacy of suicide prevention applications (apps) for scalability. This online four-arm parallel randomised controlled superiority trial will enrol 1480 young people aged 16-24 years with current suicidal ideation in New Zealand and Australia. Participants will be randomised to one of three therapeutic apps developed in different countries, Tune In, Bro and LifeBuoy, or to My Mood (attention control). The primary outcome is suicidal ideation severity at 30-day and 90-day post-baseline; secondary outcomes include mental well-being, engagement and acceptability. Emotional regulation will be examined as a mediator of change in suicidal ideation. All outcomes are measured by self-reported scales incorporated in an online questionnaire. Acceptability of the apps for rangatahi Māori (Indigenous youth, New Zealand) will be explored via semi-structured interviews. Linear mixed models with repeated measures analyses, using maximum likelihood estimation, an appropriate covariance structure and consideration of site effects, will be undertaken. Examination of an individual app intervention effects in New Zealand and Australia will highlight the effects of apps developed for a different country. Approval was obtained (26 February 2025) from the Health and Disability Ethics Committees (Ministry of Health ref 2025 EXP 21500). Participants provide informed consent online. Trial results will be submitted for publication in peer-reviewed journals, shared on relevant websites and via presentation at international scientific conferences; Individial Patient Data will only be shared if requested and subsequent to review. ACTRN12625000349448.

Oedema and ecchymosis are common after rhinoplasty and may delay recovery. Photobiomodulation (PBM) has been shown to have analgesic, anti-inflammatory and regenerative effects; however, its role in rhinoplasty remains underexplored. This study aims to evaluate the effectiveness of PBM in reducing periorbital oedema in patients undergoing rhinoplasty. This is a single-centre, randomised, controlled, double-blind clinical trial that will include 60 participants allocated into two groups: a control group (n=30), receiving sham PBM before surgery, and an intervention group (n=30), receiving preoperative PBM followed by rhinoplasty. PBM will be delivered using a cluster device containing three red low-level laser diodes (660 nm, 150 mW each) and three infrared low-level laser diodes (808 nm, 150 mW each), applying 12 J per point for 80 s at three standardised facial sites. The intervention (PBM or sham) will be applied 1 hour before the surgical procedure. The primary outcome will be periorbital oedema on postoperative day 3, assessed using the Hoffmann clinical scale. Standardised photographic analysis using ImageJ software will be employed as a complementary measure. Secondary outcomes will include oedema at additional follow-up time points, ecchymosis, postoperative pain assessed using the visual analogue scale, nasal tip skin thickness, analgesic consumption and patient-reported aesthetic and functional outcomes assessed using the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) questionnaire. Follow-up assessments will be conducted at 3, 7, 30, 60 and 90 days, as well as at 6 and 12 months. Data will be analysed using parametric or non-parametric tests according to data distribution. The study was approved by the Research Ethics Committee of Irmandade da Santa Casa de São Paulo (protocol number: 7503097), will be conducted in accordance with the Declaration of Helsinki and current Brazilian regulations for research involving human participants and registered at ClinicalTrials.gov (NCT07033039). Written informed consent will be obtained from all participants prior to enrolment. The results will be disseminated through peer-reviewed scientific publications, presentations at national and international scientific conferences, and communication of findings to interested participants. NCT07033039.

School health policies and practices are key components of health promotion for children and adolescents and play a central role in shaping healthy school environments, reducing health inequities, and fostering intersectoral collaboration between education and health systems. Despite their relevance, systematic and comparable assessments of how these policies and practices are implemented across different national contexts remain limited, particularly in low- and middle-income countries. Internationally comparable data are essential to identify strengths, gaps, and priorities for investment in school health. The aim of this study is to describe the protocol of a mixed methods study evaluating and comparing school health policies and practices in Brazil and Portugal. An explanatory sequential mixed methods design (QUAN → qual → [qual] → [qual]) will be adopted. The quantitative phase (phase I) consists of a cross-sectional survey conducted with school administrators using the Global School Health Policies and Practices Survey, which assesses multiple domains of school health policies, coordination, services, and practices. Quantitative findings will inform the subsequent qualitative phases. Phase II involves semistructured interviews with school principals or head teachers to explore institutional decision-making and policy implementation. Phase III includes interviews with school nurses to examine health service organization, intersectoral collaboration, and professional practices. Phase IV comprises participatory research with adolescents using the photovoice technique to capture youths' perspectives on school health environments and practices. The study will be conducted in elementary and secondary schools and related health services in selected cities in Brazil and Portugal. Data integration will occur sequentially through connected analyses and joint displays, enabling the development of meta-inferences that link quantitative patterns with qualitative explanations. The study has secured funding from 2 funding agencies, with project activities initiated in 2025. Quantitative data collection and analysis began in October 2025 in the city of Cuiabá, Brazil. The expansion of data collection to additional Brazilian and Portuguese cities is planned for the first half of 2026. The qualitative phases, including interviews and photovoice activities, are scheduled to take place throughout 2026. The final integrated mixed methods analysis and manuscript preparation are planned for 2027, with dissemination of findings through peer-reviewed journals and national and international scientific conferences by the end of the project cycle. This study is expected to generate context-sensitive and comparative evidence to support intersectoral actions and inform the development and strengthening of school health promotion policies and practices in different national settings.

The purpose of this study is to gain new scientific knowledge about current scientific areas of Belarusian linguistics using the example of a review of 11 abstracts of Doctoral dissertations defended in 2016-2024. The analysis accounts for the geographical diversity of scientific conferences attended by Belarusian linguists, their scholarly articles published in Belarus and Russia prior to the defense, and the professional affiliations of official opponents, which serve as evidence of the established international cooperation between linguists within the Union State. The scientific novelty lies in the fact that the article summarizes their contribution to the study of two scientific specialties on 10.02.19 – Theory of Language and 10.02.20 – Comparative historical, typological and comparative linguistics based on information from two sections of the abstracts of doctoral dissertations of Belarusian scientists “Approbation of research results” and “List of publications of the applicant on the research topic”. As a result, the current directions of linguistic research of Belarusian Doctors of Philology have been identified, the frequency of their participation in international scientific conferences in Belarus and Russia has been established, and the facts of opposition to doctoral dissertations by Russian linguists have been revealed. This information can be useful for expanding the scientific horizons and professional development of young philologists.

IntroductionOxaliplatin is widely used in the treatment of gastric and gastro-oesophageal junction cancer. However, oxaliplatin-induced nausea and vomiting often complicate treatment and negatively affect patients’ quality of life. The current standard antiemetic regimen—dexamethasone (DEX) plus palonosetron—offers only limited efficacy, benefiting approximately 70% of patients, and is associated with steroid-related adverse effects, including insomnia and gastrointestinal bleeding. Consequently, there is a clear clinical need for effective DEX-free antiemetic regimens. This study aims to evaluate the efficacy and safety of megestrol acetate versus DEX in preventing oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer.Method and analysisThis is an investigator-led, multicentre, randomised-controlled, open-label, phase III, non-inferiority trial. Chemotherapy-naïve patients scheduled to receive oxaliplatin-based chemotherapy are randomly (1:1) assigned to receive either megestrol acetate (megestrol acetate group) or DEX (DEX group) in combination with palonosetron. The primary endpoint is the complete response (CR; no vomiting and no rescue therapy) rate during the first 120 hours following the initiation of chemotherapy (0–120 hours). Secondary endpoints include the following indicators: CR rate in acute period (0–24 hours), CR rate in delayed period (24–120 hours), time to treatment failure, frequency of salvage medication use, nausea, anorexia, adverse events and quality of life.The study will evaluate the efficacy and safety of megestrol acetate compared with DEX for prevention of oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer. If proven effective, the results might inform future antiemetic strategies in the long term to (1) provide a novel DEX-free antiemetic treatment for prevention of moderate-emetogenic chemotherapy, (2) reduce DEX-related adverse effects and improve quality of life in patients with gastric or gastro-oesophageal junction cancer and (3) support the potential incorporation of megestrol acetate into standard antiemetic medications.Ethics and disseminationThe study protocol is conducted in accordance with the Declaration of Helsinki and approved by the Certified Review Board of West China Hospital, Sichuan University (Ethics Approval No 1116/2023). The results of this study will be disseminated via presentations at national and international scientific conferences and publication in peer-reviewed journals.Trial registration numberChiCTR2300075943.

Sedentary behaviour is associated with an increased risk of cardiovascular disease and all-cause mortality in people with type 1 diabetes (T1D). Recent research has found that interrupting prolonged sitting with low-intensity activity acutely improves glycaemic management in people with T1D who use multiple daily insulin injections or continuous subcutaneous insulin infusion. However, the acute glycaemic effects of breaking up sitting with low-intensity walking on people with T1D using hybrid closed-loop (HCL) insulin systems are yet to be examined. The primary aim of the present study is to investigate the influence of breaking up 7 hours of sitting with 3 min intervals of low-intensity walking every 30 min on glucose management in individuals with T1D who use HCL systems. Adults with T1D (n=24), who use HCL systems, will complete two experimental conditions in this randomised cross-over trial. One condition will require sitting uninterrupted for 7 hours (Sedentary), while the other will require breaking up 7 hours of sitting with 3 min of low-intensity walking every 30 min (Active Breaks). During both conditions, interstitial glucose concentrations (via CGM) and insulin administration (via HCL) will be recorded throughout. In addition, peripheral vascular function (via flow-mediated dilation) and cerebral vascular function (via CO2 reactivity) will be measured at baseline and post. Data will be analysed using paired t-tests and analyses of variance. The trial has been approved in the UK by the London City and East Research Ethics Committee (25/PR/0098). The findings from the study will be disseminated through peer-reviewed journals and presentations at national and international scientific conferences. Trial registration number: ISRCTN56375691.

Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered the standard of care for the treatment of peritoneal metastases from gastrointestinal and gynaecological cancers. Characterised by substantial intraoperative fluid shifts and increased endothelial permeability, this procedure is associated with adverse perioperative outcomes. Human albumin has been extensively studied in critically ill patients as an intravenous fluid, but its efficacy during major non-cardiac surgery involving substantial fluid requirements remains insufficiently evaluated. The aim of this trial is to evaluate the efficacy of 20% albumin in combination with Ringer's lactate versus Ringer's lactate alone for fluid therapy during CRS with HIPEC in relation to postoperative outcomes. The study protocol was designed and written in accordance with the Prospective Randomised Open, Blinded Endpoint design and followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) recommendations. This is a randomised controlled, open-label parallel-group multicentre clinical trial. Participants will be patients admitted for CRS with HIPEC. Eligible patients will be randomly assigned to either the control group (Ringer's lactate) or the intervention group (20% albumin+Ringer's lactate) in a 1:1 ratio, with stratification by centre. The primary outcome is the Comprehensive Complication Index (CCI) score at day 28 following CRS with HIPEC. Secondary endpoints include mortality at day 28, CCI score at day 7, volume of intraoperative and postoperative (48 hours) fluid therapy, cumulative incidence of surgical and medical postoperative complications, and number of days alive and out of the hospital by day 28. To ensure 90% power, a total of 140 patients (70 per group) are required to detect a 13.6-point reduction in the CCI score on day 28 in the intervention group, assuming a SD of 24. The study has been authorised by the Clinical Trials Information System and approved by the European Ethical Committee (EU CT number 2024-5 10 943-76-00). Clinicians will explain the details of the study to all eligible participants. Written informed consent will be obtained from all participants prior to randomisation. The results of the study will be communicated to healthcare professionals and the public through presentations at international scientific conferences and publication in peer-reviewed medical journals. The trial has been registered on ClinicalTrials.gov (NCT06351475).

The article contains a summary prepared by the direction of the organizing committee of the traditional International Scientific and Practical Conference of the Tajik Technical University named after Academician M.S. Osimi” Science is the basis of innovative development", regarding the commentary of the conference title. Much attention is paid to the role of science in the development of modern society, especially in the development of its economic activities. The article presents assumptions about the transformation of science into an independent and effective branch of the economy in modern society. It highlights the need for widespread use of scientific achievements to achieve Tajikistan's strategic goals. Keywords: culture, economy, science, productive forces, methods of production, automation, artificial intelligence.

IntroductionOlder people who die with a serious chronic disease are at risk of experiencing extended periods (ie, months or years) of fluctuations and deterioration in their health and well-being. Traditional categorisations of these end-of-life trajectories focus on physical functioning and often consider three types (ie, cancer, organ failure, frailty/dementia), but data supporting these categories are limited, often neglect psychological, social and existential domains of health and well-being and provide little information on the extent and determinants of variation in end-of-life trajectories. This study aims to identify distinct temporal patterns in the trajectories of older people with serious chronic illness and determine to which extent personal, clinical and social characteristics predict them.Methods and analysisWe have developed and piloted a novel, feasible and acceptable study protocol for a longitudinal survey study with older people nearing the end of life. We will conduct a longitudinal survey study with 280 older people, aged 70 years or over, who have one or more chronic illnesses and who are in deteriorating health. Assessments will be done at baseline and every 2 months, over 12 months or shorter if the participant dies before. Deteriorating health is determined based on disease-specific criteria which we developed in collaboration with clinical specialists. People without cognitive capacity to consent to research participation, those in the terminal phase of life (ie, last days) and those who cannot participate in data collection in Dutch or French will be excluded. Participants will be recruited from hospitals in Belgium. The survey covers health and well-being in the physical, social, psychological and existential domains and determinants related to sociodemographic, clinical and social environment characteristics. When a participant dies, we will invite an adult proxy respondent (a family member or another close person) to complete a mortality follow-back study covering the deceased participants’ health and care in the last 3 months of life. We will analyse trajectories with latent class growth models and mixed-effects models.Ethics and disseminationThe TRAJECT project has received approval from the Commissions for Medical Ethics from Universitair Ziekenhuis Brussel (Brussels University Hospital) and Ghent University Hospital. The findings of the study will be disseminated through scientific publications in international peer-reviewed journals and scientific conferences. For non-expert audiences, updates and findings will be shared through the project website, press releases and events for the general public.

"Applied Mechanics and Materials" is a peer-reviewed journal which specializes in the publication of proceedings of international scientific conferences, workshops and symposia as well as special volumes on topics of contemporary interest in all areas which are related to: 1) Research and design of mechanical systems, machines and mechanisms; 2) Materials engineering and technologies for manufacturing and processing; 3) Systems of automation and control in the areas of industrial production; 4) Advanced branches of mechanical engineering such as mechatronics, computer engineering and robotics. Applied Mechanics and Materials" publishes only complete volumes on given topics, proceedings and complete special topic volumes. Authors retain the right to publish an extended, significantly updated version in another periodical. All published materials are archived with PORTICO and CLOCKSS. Presented, Distributed and Abstracted/Indexed in: Inspec (IET, Institution of Engineering Technology) www.theiet.org. Chemical Abstracts Service (CAS) www.cas.org. Google Scholar scholar.google.com. NASA Astrophysics Data System (ADS) http://www.adsabs.harvard.edu/. Cambridge Scientific Abstracts (CSA) www.csa.com. ProQuest www.proquest.com. Ulrichsweb www.proquest.com/products-services/Ulrichsweb.html. EBSCOhost Research Databases www.ebscohost.com/. Zetoc zetoc.jisc.ac.uk. Index Copernicus Journals Master List www.indexcopernicus.com. WorldCat (OCLC) www.worldcat.org.

Serdecznie witamy na eJournals. Portalu Czasopism Naukowych! eJournals to nie tylko platforma do publikowana online, ale również doświadczony zespół Wydawnictwa Uniwersytetu Jagiellońskiego oferujący wsparcie dla Redakcji czasopism w zakresie prowadzenia i rozwoju Czasopisma. Misją eJournals jest wspieranie polskich naukowców oraz zapewnienie przedstawicielom redakcji Czasopism profesjonalnej pomocy w ciągłym podnoszeniu ich poziomu i utrzymaniu wysokich standardów światowych. Wdrażanie międzynarodowych standardów i dobrych praktyk wraz z nowoczesnymi narzędziami publikowania może wpływać na bardziej skuteczne aplikowanie do naukowych baz danych, zwiększanie liczby cytowań, sprawniejszą migrację danych w bazach naukowych i budowanie lepszej widoczności w sieci. Wspieramy Redakcje w działaniach z zakresu informacji naukowej w celu stałego podnoszenia prestiżu Czasopism.

Accessible, person-centred, non-pharmacologic modalities are needed to address chronic pain and health-related quality of life (HRQoL) among individuals with sickle cell disease (SCD). Building off prior single-site pilot studies of music therapy (MT) in SCD, the purpose of this study is to (1) examine the data collection processes and intervention implementation overall and across two sites and (2) evaluate the implementation of the MT and health education interventions using quantitative and qualitative data. This three-arm, two-site, feasibility randomised controlled trial will include 90 individuals ≥14 years who have SCD, chronic pain and access to a mobile device who are not currently engaged in mind-body pain management interventions under the supervision of a healthcare professional. Participants will be randomised to six sessions over 8 weeks of either: (1) in-person MT, (2) hybrid (one in-person, five virtual) MT or (3) hybrid health education. Patient-reported outcome measures of HRQoL and self-efficacy will be assessed at baseline, post-intervention and 6 weeks post-intervention. 24 participants (eight per arm) and 20 stakeholders (eg, haematologists, music therapists, nurses) will be invited to complete semi-structured interviews to further examine intervention acceptability, perceived benefits and implementation. Sessions will be monitored for fidelity, and participants lacking access to home internet or videoconferencing technology will be provided tablets to engage in virtual sessions. Feasibility will be determined by rates of data completion, recruitment, retention, session attendance and home practice. This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board (STUDY20231055). The dissemination plan includes presenting findings at national and international scientific conferences and publishing in peer-reviewed journals. All activities will be conducted in collaboration with SCD community stakeholders. NCT06853158.

XХVII International Scientific Conference “Chemistry and Chemical Engineering in XXI Century”

IntroductionIn May 2023, the US Food and Drug Administration (FDA) initially approved an AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) for adults aged ≥60 years. The approval was expanded in June 2024 to include adults 50–59 years of age at increased risk for RSV-associated lower respiratory tract disease. In this paper, we describe the protocol of a postmarketing safety study evaluating the association between adjuvanted RSVPreF3 and new-onset Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis (ADEM) and atrial fibrillation (AF) among adults ≥50 years of age in the USA and provide our rationale for key methodological decisions.Methods and analysisThe potential associations between adjuvanted RSVPreF3 and GBS, ADEM and AF will be evaluated using secondary healthcare data and the self-controlled risk interval (SCRI) design. Data from five research partners in the USA spanning August 2023 through June 2030 will be used for the conduct of yearly monitoring queries and, sample size permitting, SCRI analyses. Claims-based definitions for new-onset outcomes (first diagnosis in 365 days) are: ≥1 inpatient diagnosis for GBS and ADEM; ≥1 inpatient or ≥2 ambulatory/emergency diagnoses for AF. The primary risk and control windows are 1–42 and 43–84 days, respectively, for GBS and ADEM; and 1–8 and 9–16 days for AF. SCRI analyses for GBS and ADEM will include chart-confirmed cases. SCRI analyses for AF will adjust for the positive predictive value obtained from validation against charts. Conditional Poisson regression will be used to calculate incidence rate ratios.Ethics and disseminationThis study was approved by the Institutional Review Boards (IRB) of Harvard Pilgrim Health Care Institute; WIRB-Copernicus Group, Inc and its affiliates (collectively, ‘WCG’); WCG IRB, Inc; and Sterling IRB, with Federal Wide Assurance (FWA) numbers FWA00000100, FWA00033319 and FWA00025632, respectively, for all participating research partners. Study results will be shared with the US FDA and publicly disseminated through national or international clinical or scientific conferences and peer-reviewed publications.RegistrationThis protocol has been registered in the Heads of Medicines Agencies–European Medicines Agency Real World Data Catalogues (EUPAS1000000486).

International scientific conferences expose nursing students to current evidence, professional identity formation, and global networks, yet participation remains low. We aimed to identify evaluated interventions designed to increase nursing students’ participation in international scientific conferences. Following PRISMA 2020, we searched PubMed, CINAHL, Scopus, and Web of Science for English/Japanese records from January 2005 to 31 May 2025. We also examined three International Council of Nurses (ICN) Congress proceedings items authored by the research team as contextual sources. Two reviewers independently screened titles/abstracts. Eligible studies targeted pre-licensure undergraduate nursing students and evaluated strategies intended to increase participation, reporting objective participation outcomes (e.g., abstract submission, registration, attendance, presentation). Database searches identified 173 records. After removing 58 duplicates, 115 records were screened by title and abstract. All 115 records were excluded at the title/abstract stage; therefore, no eligible evaluative studies were identified (n = 0). No evaluated interventions were identified. This empty review highlights an actionable evaluation gap. Informed by implementation and behavior-change theory and adjacent evidence, we outline implementation implications that can be adopted and monitored using routine indicators (key performance indicators) and iterative improvement cycles (Plan–Do–Study–Act).

The International Scientific Conference in the “Humanistic Ecology” series, entitled Environmental Philosophy and Environmental Ethics in the Face of the Ecological Crisis, was held in Warsaw on 18–20 August 2025. Co-organized by Studia Ecologiae et Bioethicae (SEeB), it brought together scholars representing a range of disciplines, including environmental philosophy, ethics, theology, education, law, and the social sciences. Over three days, participants presented a broad spectrum of research and analyses addressing the contemporary ecological crisis, the human–nature relationship, sustainable development, and the ethical consequences of ongoing environmental change. In addition to plenary sessions, the programme included parallel thematic sessions that enabled in-depth discussion of climate change, biodiversity, environmental responsibility, and the axiological foundations of responses to ecological challenges. The conference also strengthened international academic cooperation within the “Humanistic Ecology” network. An important outcome was the support of publication pathways in SEeB: selected papers have already been published or made available as Online First articles, while further texts remain under editorial development.

Chemotherapy-induced nausea and vomiting (CINV) is a common symptom in cancer, and it is one of the distressing symptoms in patients with cancer receiving chemotherapy. Information about side effects may exacerbate CINV due to the nocebo effect. This study aims to examine the efficacy of pharmacist-led enhanced support for coping with side effects during medication counselling, which includes providing information about side effects, with the goal of mitigating the nocebo effect and reducing CINV. This multicentre exploratory open-label randomised controlled trial will examine the efficacy of pharmacist-led enhanced support for coping with the side effects of treatments during medication counselling in patients with advanced lung cancer. The control group will receive medication counselling as usual. The study population will consist of patients with advanced lung cancer who have not received chemotherapy and are receiving highly emetogenic chemotherapy or equivalent chemotherapy. The primary endpoint is the prevention of nausea, and the secondary endpoints include complete response (no vomiting event and no rescue medication), stress (objectively assessed using the salivary cortisol and immunoglobulin A), coping strategies and quality of life. This study received approval from the medical ethics committee of Kansai Medical University. The results will be submitted for publication in an international peer-reviewed journal, and the findings will be presented at international scientific conferences. 1.0, 18 Mar 2025 TRIAL REGISTRATION NUMBER: Registration number: UMIN000056068.

Increasing evidence suggests that dolutegravir (DTG), endorsed by the WHO since 2018 for first-line antiretroviral therapy (ART), is associated with significant weight gain and potentially also with cardiometabolic disorders. In an effort to expand therapeutic options for people living with HIV (PLHIV), the EvaLuating the non-inferiority of DORAvirine vs DOlutegravir trial aims to compare the virologic efficacy of doravirine (DOR) and DTG-based regimens and to assess their safety, including a focus on cardiometabolic effects. This is an international, phase III, multicentre, open-label, non-inferiority, randomised trial that will enrol 610 ART-naïve PLHIV (HIV RNA≥1000 copies/mL at screening) across six countries (Brazil, Cameroon, France, Côte d'Ivoire, Mozambique and Thailand) spanning four continents. Key inclusion criteria include age ≥18 years, confirmed HIV-1 infection with plasma RNA levels ≥1000 copies/mL, indication for ART initiation and no prior ART exposure. Participants will be randomised in a 1:1 ratio to receive either DOR 100 mg once daily in combination with tenofovir disoproxil fumarate (TDF) (300 mg daily) plus lamivudine (3TC) (300 mg daily) or DTG (50 mg daily) in combination with TDF (300 mg once daily) plus either emtricitabine (FTC) (200 mg daily) or 3TC (300 mg daily). Randomisation will be stratified by screening HIV-1 RNA load (≤100 000 or >100 000 copies/mL) and by country. The primary outcome is virological efficacy, defined as the proportion of participants achieving HIV-1 RNA <50 copies/mL at week 48 on the assigned treatment (FDA Snapshot algorithm). Secondary outcomes include cardiometabolic safety endpoints (ie, weight gain, insulin resistance, hypertension, diabetes, waist and hip circumferences, waist-to-hip ratio, fasting glycaemia, insulin and fasting serum lipids), along with mental health, quality of life, virological and immunological parameters. Final data collection is expected by July 2028. Primary outcome results (week 48) are expected in early 2028. The project was submitted to and approved by national ethics committees and pharmaceutical regulatory authorities in all participating countries: Brazil (CEP INI FIOCRUZ (21.040-900)/CEP HGNI (26.030-380)); Cameroon (CNERSH (2024/09/1717/CE/CNERSH/SP)/Ministry of Public Health (D30-1464/AAR/MINSANTE/SG/DROS/CRC); Côte d'Ivoire: (CNESVS (0018224/MSHPCMU/CNESVS-km)/AIRP (1329/AIRP/DISMP/Om/kbaag); France (CTIS CPP/ANSM (2023-508626-10-00)); Mozambique (CNBS (20/CNBS/25)/ANARME (4635/380/ANARME)); Thailand: (IHRP (08/1944)/Thai FDA: ongoing on 19 January 2026). The trial received authorisation from the French National Commission for Data Protection and Liberties (CNIL) under approval number 924 302. Written informed consent is obtained from all participants prior to any study-specific procedures and trial enrolment, in accordance with the Declaration of Helsinki and applicable national regulations. Study findings will be disseminated through publication in peer-reviewed journals and presentations at national and international scientific conferences. Results will also be communicated to policymakers, healthcare professionals, community stakeholders and study participants through appropriate dissemination activities, including policy briefs, stakeholder meetings and lay summaries on dedicated and easily accessible platforms. NCT06203132; EU-CT, 2023-508626-10-00.

Sympathetic activation is the hallmark of cardiac disease, driving disease progression and triggering ventricular arrhythmia (VA). Despite optimal medical therapy, many patients experience recurrent VAs refractory to medical therapy, leading to repetitive implantable cardioverter defibrillator (ICD) therapy, worse quality of life and adverse outcomes. Cardiac sympathetic denervation (CSD) through surgical removal of the stellate ganglia is an effective treatment for refractory VAs but carries a high complication rate. We hypothesise that high precision image guided radiotherapy can be used to target the stellate ganglia to achieve CSD non-invasively. RADIO-STAR (hypofractionated radiotherapy to the stellate ganglia for ventricular arrhythmia) is a first-in-human, phase 1 safety and dose finding study of radiotherapy to the stellate ganglia in patients with recurrent VAs. Patients with structural heart disease requiring recurrent ICD therapy for VAs are invited to undergo radiotherapy bilaterally to their stellate ganglia with a predetermined sample size of n=13. Radiotherapy dose will be determined by a prespecified dose escalation protocol. The primary outcome is safety defined as any treatment-related grade 3-5 toxicity occurring within 6 months of radiotherapy treatment, as defined by the Common Terminology Criteria for Adverse Events or any treatment-related side effects detected on patient symptom questionnaires and clinical examination during study visits. Secondary outcome measures to evaluate feasibility and efficacy include ability to safely deliver radiotherapy and consequent changes in circulating catecholamines and neuropeptide-Y, heart rate variability, structural changes in the stellate ganglia on MRI imaging and ICD therapy burden. This study has received ethical approval by the South Central-Oxford B Research Ethics Committee (REC/SC/0005). Study findings will be submitted for publication in peer-reviewed scientific journals and presented at national and/or international scientific conferences. ISRCTN49861434.