Conectar
by Kazuhiro Omori, Kohei Furukawa, Masatoshi Usubuchi, Tomofumi Hamada, Tadahiko Shien, Michihiro Yoshida, Yuki Nakatsuka, Katsuyuki Hotta, Soichiro Ibaragi, Shogo Takashiba
Oral mucositis is a frequent and debilitating adverse event observed in patients undergoing chemotherapy or radiotherapy. Current management strategies are limited in duration, require frequent application, and fail to address the mechanical irritation from teeth. A novel device, Soft Protector CPC, was developed to overcome these limitations. This multicenter, randomized, two-arm, open-label, confirmatory trial aims to evaluate the efficacy and safety of Soft Protector CPC in patients with breast cancer undergoing chemotherapy. A total of 154 participants will be randomly assigned in a 1:1 ratio to receive either oral care with Soft Protector CPC or oral care alone. The primary endpoint will be oral mucositis as assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 during the comparative treatment period. The secondary endpoints will include CTCAE v3.0 during the continuous treatment period, oral mucositis, pain (CTCAE v5.0), quality of life (Patient Reported Outcomes-CTCAE version 1.0 [PRO-CTCAE v1.0], the 15-item oral health questionnaire of the European Organization For Research And Treatment Of Cancer [EORTC QLQ-OH15], and the pain Numeric Rating Scale), onset and site of mucositis, completion of chemotherapy, use of rescue medications, technical feasibility, and patient preference. The safety endpoints will include adverse events, device malfunction, and laboratory tests. This trial is expected to establish the clinical utility of the Soft Protector CPC for the prevention and management of oral mucositis, with the potential to improve the patients’ quality of life and adherence to cancer therapy. This study was approved by the Clinical Research Review Board and registered with the Japan Registry of Clinical Trials, jRCTs062250005, on April 18, 2025.This study aimed to develop prediction models for symptoms of poor mental health among Lebanese adults and adult Syrian refugees or migrants residing in a suburb of Beirut, Lebanon, separately.
Nested cross-sectional study.
Sin-El-Fil, a suburb east of Beirut, Lebanon.
Lebanese and Syrian adults residing in low socio-economic status areas of Sin-El-Fil.
Primary outcome was having depressive symptoms, ascertained through the Patient Health Questionnaire-9 where a total summative score of 10 or more indicated having depressive symptoms. Secondary outcome was having anxiety symptoms, ascertained through the Generalised Anxiety Disorder-7 where a total summative score of 10 or more indicated having anxiety symptoms.
Of 1986 participants, 1322 (66.5%) were Lebanese adults, 664 (33.5%) were Syrian refugees or migrants. Among Lebanese adults and adult Syrian refugees or migrants, 324 (25.3%) and 289 (43.9%) had depressive symptoms, respectively. Having pain that impacts usual activity, having debt, not feeling safe at home and having none or one person to count on in difficult times were common predictors of depressive and anxiety symptoms among Lebanese adults and Syrian refugees or migrants. Not having a legal residency permit was also a predictor of depressive symptoms for Syrian refugees or migrants. Prediction models developed for depressive and anxiety symptoms among both nationalities had good performance measures.
The predictors of poor mental health included financial, health and social indicators for both Lebanese adults and Syrian refugees or migrants during the concurrent crisis in Lebanon. These models are most applicable in similar urban, crisis-affected and low-resource settings. Findings emphasise the need for social protection and financial support among populations with vulnerabilities.
Metabolic dysfunction-associated steatotic liver disease (MASLD) and gestational diabetes mellitus (GDM) are prevalent metabolic disorders in pregnancy, posing significant risks to maternal and fetal health. This study evaluates the effectiveness of metformin, in combination with lifestyle modifications, compared with lifestyle modifications alone, in reducing the incidence of diabetes, pro-inflammatory liver markers, adverse maternal and neonatal outcomes and total gestational weight gain in pregnant women diagnosed with MASLD in the first trimester.
This parallel-arm, randomised controlled trial will recruit pregnant women (≤14 weeks of gestation) with confirmed MASLD from antenatal clinics of tertiary care public hospitals in Puducherry, India. Participants will be consecutively enrolled until a sample size of 296 is reached. Block randomisation will ensure balanced group allocation, with allocation concealment maintained using sequentially numbered opaque sealed envelopes. The intervention group will receive oral metformin (500 mg two times per day) alongside structured lifestyle modification counselling, while the control group will receive lifestyle modification counselling alone. Primary outcomes include GDM incidence, changes in pro-inflammatory markers, MASLD grading (assessed via liver function tests and ultrasound) and adverse maternal outcomes such as hypertensive disorders, polyhydramnios, genitourinary infections, caesarean delivery and postpartum haemorrhage. Neonatal outcomes assessed include macrosomia, stillbirth, intrauterine death, birth injury, shoulder dystocia, respiratory distress and neonatal hypoglycaemia. The secondary outcome is total gestational weight gain. Participants will be followed at 24–28 weeks, 34–36 weeks and post partum (within 6 weeks of delivery). Data collection will be conducted using a pretested structured questionnaire, with data entry and management performed using REDCap software. Statistical analysis will be conducted using STATA V.4, applying both intention-to-treat and per-protocol analyses. Effect sizes will be reported as proportions and relative risks with 95% CIs, ensuring robust statistical inference.
This study provides a rigorous framework to assess metformin’s role in managing MASLD and preventing GDM, thereby promoting favourable maternal and neonatal outcomes. Findings will contribute to improved clinical management, public health strategies and policy recommendations.
The study was approved by the JIPMER Institutional Ethics Committee (JIP/AEC/2023/01/011), and the findings will be disseminated through peer-reviewed journals and academic conferences.
CTRI/2023/12/060930.
by Nailya Ibragimova, Arailym Aitynova, Seitzhan Turganbay, Marina Lyu, Alexandr Ilin, Tamari Gapurkhaeva, Galina Ponomareva, Karina Vassilyeva, Diana Issayeva, Amirkan Azembayev, Serzhan Mombekov, Aralbek Rsaliyev, Nurgul Sikhayeva, Yergali Abduraimov, Saki Raheem
Iodine-based antiseptics are essential in wound care but are often limited by cytotoxicity, instability, and rapid iodine release. Novostron is a novel polymer–iodine complex incorporating dextrin, polyvinyl alcohol, and metal ions, designed to enable controlled iodine release. Structural integrity and composition were confirmed by ¹H and 13C NMR spectroscopy and physicochemical analysis, indicating a molecular weight of ~9500 g/mol, a pH of 4.23, and an iodine content of 8.13%. Pharmacokinetic analysis in rabbits demonstrated that following a single dermal application, systemic iodine absorption was minimal, with peak blood iodine concentrations remaining within physiological limits and rapid elimination within 24 hours. Evaluation of thyroid function revealed no significant changes in serum T₃, T₄, or TSH levels compared with those of the controls, confirming that topical application of Novostron does not disrupt thyroid homeostasis. In compliance with OECD guidelines in rabbits, guinea pigs, and rats, Novostron showed no signs of dermal irritation, skin sensitization, or systemic toxicity (LD₅₀ > 2000 mg/kg). In a rat cotton pellet granuloma model, Novostron significantly reduced the inflammatory mass (23.65% inhibition), supporting its anti-inflammatory potential. In a murine burn model, Novostron accelerated wound contraction (25.95% at day 10), increased epidermal thickness, and enhanced collagen deposition (~44%), outperforming controls and matching or exceeding betadine. These findings suggest that Novostron promotes tissue repair by modulating inflammation. Overall, Novostron demonstrated a favourable preclinical safety and efficacy profile, and its polymer–iodine composition, which enables controlled release and localized activity highlights its potential as a promising topical therapeutic. However, the study was limited to animal models and short-term observation; further long-term and clinical investigations are needed to confirm its translational potential in human wound healing.The global burden of malnutrition is compounded by the challenges of obesity and sarcopenia, a combination known as sarcopenic obesity. This condition, defined by increased fat mass alongside declining muscle mass and function, poses significant health risks, including metabolic dysregulation and cardiovascular complications. Despite its growing prevalence and clinical importance, significant gaps remain regarding the application of e-health strategies to address sarcopenic obesity. This scoping review aims to map the current evidence on the use of e-health in addressing sarcopenic obesity in adults with overweight or obesity, identify barriers and facilitators to its implementation, and highlight areas for future research.
The scoping review will be conducted in accordance with established methodological framework by the Joanna Briggs Institute (JBI), employing a comprehensive three-step search strategy across multiple databases and grey literature sources, including PubMed, Embase, Cochrane, CINAHL, Web of Science and Scopus. The inclusion criteria, framed by the Population-Concept-Context (PCC) framework, will focus on studies involving adults with sarcopenic obesity and interventions using e-health approaches in various healthcare contexts. A data extraction form will be used to guide the data extraction. Findings will be synthesised narratively and in tabular form, comprehensively mapping the current evidence and identifying key areas for future research.
Ethical approval is not required as the review analyses publicly available data. Findings will be published in a peer-reviewed journal and presented at international conferences and scientific forums. The review will offer insights into e-health integration in sarcopenic obesity management, informing clinical practice, policy development and interdisciplinary collaboration.
This scoping review was registered with the Open Science Framework registry on 17 September 2024 (https://doi.org/10.17605/OSF.IO/9ND5A).
Cognitive Behavioural Therapy (CBT) has demonstrated positive effects on emotional well-being and quality of life in individuals with dementia. Limited evidence constrains the generalisability of these findings.
This review was conducted in accordance with PRISMA guidelines. Randomised controlled trials (RCTs) that implemented CBT and assessed cognitive function, depressive symptoms, anxiety and quality of life in individuals with dementia were included. Seven databases—APA PsycINFO, CINAHL, Cochrane Library, Embase, MEDLINE, PubMed and Web of Science—were searched up to 10 October 2024. The Risk of Bias 2 (RoB-2) tool was used to evaluate the methodological quality of included studies. Pooled standardised mean differences (SMDs) with 95% confidence intervals (CIs) were calculated using random-effects models for each outcome.
A total of 10 RCTs, involving 1412 individuals with dementia and published between 2011 and 2024, were included in the analysis. CBT was associated with a reduction in anxiety (pooled SMD = −0.94; 95% CI = −1.33 to −0.55; I 2 = 0.00%; p < 0.04). No significant differences were found in cognitive function, depression or quality of life between those receiving CBT and those in the control groups.
This study suggests that CBT alleviates anxiety in people with dementia. However, further investigation is required to clarify its effects on cognitive function, depressive symptoms and quality of life. Future research should focus on the development of CBT protocols, alongside the exploration of relevant outcome measures.
CBT has shown potential in improving emotional well-being and quality of life in individuals with dementia. The findings inform healthcare professionals about its clinical utility and effectiveness in dementia care.
The findings suggest that traditional CBT may not fully address the needs of people with dementia, emphasising the importance of incorporating multisensory stimulation and caregiver involvement to enhance therapeutic outcomes.
Falls among older adults are a major public health concern, often leading to serious outcomes such as fractures, head trauma, and increased mortality. Virtual reality (VR) interventions have emerged as a promising strategy for fall prevention by improving balance, reducing fear of falling, and enhancing confidence. However, the impact of VR interventions on specific outcomes such as fear of falling, balance, and postural control in older adults remains insufficiently synthesized.
Systematic review and meta-analysis.
A comprehensive systematic search of six databases was conducted from inception to January 20, 2025. Randomized controlled trials (RCTs) evaluating VR interventions targeting fear of falling, balance, and postural control in older adults were included. Methodological quality was assessed using the Cochrane risk-of-bias tool (RoB-2). Pooled standardized mean differences (SMDs) with 95% confidence intervals (CIs) were calculated using random-effects models for each outcome.
Seventeen RCTs involving 988 older adults, published between 2016 and 2025, met the inclusion criteria. VR interventions demonstrated significant effects in reducing fear of falling (SMD = −0.40; 95% CI: −0.72 to −0.08; I 2 = 45.10%; p = 0.02), improving balance (SMD = 0.45; 95% CI: 0.07–0.83; I 2 = 73.54%; p = 0.02), and enhancing postural control (SMD = 0.50; 95% CI: 0.13–0.86; I2 = 46.89%; p = 0.01).
This meta-analysis highlights the effectiveness of VR interventions in reducing fear of falling and improving balance and postural control among older adults.
VR represents a valuable tool in fall prevention strategies, addressing key outcomes essential for maintaining independence and mobility in this population.
Background
Nurses’ primary role in clinical settings for persons living with dementia is to lessen the strain of dementia on daily life, monitor comorbidities, and manage medications. However, no comprehensive literature review has investigated the effectiveness of nurse-led interventions for persons living with dementia.
Objective
The purpose of this study was to evaluate randomized controlled trials on the efficacy of nurse-led dementia interventions and provide an extended range of outcomes related to cognitive function, depression, and quality of life.
Methods
A comprehensive literature search of six databases was conducted from database inception to August 10, 2022. Methodologies were evaluated, followed by a pooled analysis using random effects models to explain the effects of nurse-led dementia interventions on patients.
Results
Nurse-led interventions were more effective than standard care in alleviating depression and improving quality of life. However, they did not enhance cognitive performance.
Discussion
Nurse-led interventions for dementia alleviate depression and improve quality of life. However, because of lack of randomized controlled trials, the analysis found less effectiveness in improving cognitive function. Therefore, further trials are needed to corroborate these findings. 
FreshRSS 