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Occurrence and management of premature clinical trial termination: a survey of UK healthcare professionals
No full textAbstract Background A proportion of clinical trials terminate prematurely, due to logistical or conduct issues and emerging scientific data. Due to a paucity of literature and non-standardised reporting, the rate for all trials is unknown, and little is known about the number and experience of healthcare professionals managing this situation. This study aimed to identify how many UK healthcare professionals delivering clinical research have experienced premature trial termination, the challenges experienced and resources available for managing this situation. Methods Following ethics approval, a national e-survey of self-identifying healthcare professionals delivering clinical research was conducted (April–September 2022). Analysis included descriptive statistics and content analysis for categorization of challenges. Results A total of 65% (n = 89) of healthcare professionals had experienced ≥ 1 premature trial termination. Challenges included communicating with research participants and/or families (n = 20) and emotional distress for participants and/or families (n = 21). Forty-eight healthcare professionals identified resources; of those available for review, one resource provided guidance relating to research participants. Conclusion Premature clinical trial termination creates challenges for care delivery and impacts on participants and/or families. Healthcare professionals need preparation and training to ensure participants are appropriately supported if their trial prematurely terminates
Effects of dual-task training on attentional function among community-dwelling older adults: study protocol for a randomized controlled trial
No full textAbstract Background Attentional function is the basis of cognitive function, and its decline affects the daily lives of older adults. Previous studies have not consistently reported the effects of dual-task training (DTT) on attentional function in community-dwelling older adults. This study aims to verify the effectiveness of DTT by combining “motor tasks” and “cognitive tasks involving motor activity” with a focus on inducing dual-task interference (DTI). Methods The study design is a randomized controlled trial. The intervention consists of DTT that combines “motor tasks” involving lower limb movements with “cognitive tasks involving motor activity” incorporating complex finger movements. The program will be implemented in a DTI setting, and tasks will be adjusted individually for each participant. The intervention group will be conducted twice per week for four weeks, with each session lasting one hour. The control group will continue with the participants’ usual daily activities for four weeks. Attentional function will be assessed as the primary outcome using the Trail Making Test-Japanese and as secondary outcomes using the digit span test and the Stroop and reverse-Stroop test. Balance function will be measured using the single-leg stance test. All evaluations will be conducted at baseline and post-intervention. In the statistical analysis, paired t-tests will be used to compare pre-intervention and post-intervention changes within each group, and analysis of covariance will be used to compare intervention effects between groups. Discussion Based on the study objectives, the maintenance and improvement of attentional function should be promoted to help community-dwelling older adults maintain healthy lives in familiar environments. Trial registration UMIN, UMIN000057681. Registered on 30 June 2025. UMIN website https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000065882
Migrasomes constrained by a homologous-targeting photodynamic nanoplatform: enhancing intratumoral CD8+ T-cell-associated antitumor immunity in oral squamous cell carcinoma
No full textAbstract Photodynamic therapy (PDT) is an effective adjunct treatment for oral squamous cell carcinoma (OSCC). Enhancing photosensitizer targeting and inducing effective cytotoxic T-cell responses through photoimmunotherapy have become key strategies to improve PDT efficacy. Migrasomes, as vesicular structures assembled by TSPAN4 and cholesterol microdomains, are implicated in immune escape and are emerging as sensitization targets for PDT. Here, we report a biomimetic nanoplatform, MOF-919@CCM, that combines enhanced tumor-cell membrane adhesion with light-controlled cholesterol degradation. Cloaking with a homologous cancer-cell membrane (CCM) imparts specific adhesion to tumor cells and improves targeted delivery of the photosensitizer. Moreover, the transition-metal nodes of MOF-919 exhibit peroxidase- and catalase-like activities that alleviate tumor hypoxia and, under laser irradiation, effectively reduce cellular cholesterol levels. Experiments further revealed that PDT based on MOF-919@CCM markedly suppresses migrasome formation via effective degradation of cholesterol and promotes CD8⁺ T-cell infiltration and cytotoxic activity against tumor cells. This work develops a targeted PDT approach using MOF-919@CCM and provides a new strategy for the immunotherapy of OSCC. Graphical abstrac
The role of residential urban form and built environment in supporting social interaction, health, and well-being: a focus on forming and maintaining ties
No full textAbstract Background Social interaction is essential for health and well-being, given the growing public health concern of social isolation and loneliness. The role of the built environment in supporting social interaction has been widely studied. However, previous research has often treated social interaction as a single, undifferentiated category, although different types of interaction may serve distinct social functions and be influenced by different environmental factors. Moreover, most studies have focused primarily on residential neighborhood contexts. This study addresses these key gaps by distinguishing between two types of social interaction—tie formation and tie maintenance—and by examining built environment characteristics across broader, individualized multidimensional activity space models. Method Using data from a Public Participatory GIS (PPGIS) survey (n = 386) in Turku, Finland, this study analyzed how residential urban form and built environment features relate to tie formation and tie maintenance. Built environment features were assessed using three activity space models: 500-meter home buffer, combined buffer around home and daily destinations, and individualized activity range spanning between home and destinations. Structural Equation Modeling was used to examine how these factors influence each type of social interaction and associated psychosocial outcomes. Results Residing in urban areas was significantly associated with tie maintenance but not with tie formation. Walkability around the home supported both types of interaction, whereas parks and green spaces near daily destinations were positively associated with tie formation. A similar pattern was observed within individualized activity ranges, where park ratio predicted tie formation. These two types of social interaction influenced psychosocial outcomes through distinct pathways: tie formation had direct positive effects on health and well-being, while tie maintenance contributed indirectly through increased relationship satisfaction. Conclusion The findings emphasize the importance of distinguishing between different types of social interaction and accounting for their unique spatial and functional drivers. Urban planning and public health efforts should consider how different aspects of the built environment foster both the formation and maintenance of social ties. Promoting environments that support diverse forms of social interaction is essential not only for enhancing health and well-being but also for reducing the risk of loneliness
Exploring the neuroprotective effects of phytocannabinoids on oxygen-glucose deprived neurons in an in vitro model of stroke
No full textAbstract Background Stroke is a leading cause of death and disability worldwide, but therapeutic options to reduce or prevent neuronal damage are extremely limited. Cannabinoids exhibit antioxidant, anti-inflammatory, and receptor modulatory actions that may offer neuroprotection. While research on the potential of cannabinoids has expanded in epilepsy and neurodegeneration, the neuroprotective potential of this class of natural compounds in stroke remains underexplored. Here, we evaluated a panel of phytocannabinoids (PCs) for their ability to mitigate ischemia–reperfusion injury in an in vitro human model of stroke. Methods Human induced pluripotent stem cell (iPSC)-derived cortical neurons were subjected to 60 min of oxygen–glucose deprivation (OGD) followed by reperfusion. Neuronal survival was quantified over seven days using longitudinal live-cell imaging. Twenty-eight PCs were screened for their effect on reducing neuronal death. Results Among 28 PCs screened, seven demonstrated modest effects, with cannabigerorcinic acid (CBGOA) significantly improving post-OGD neuronal survival. While OGD exposure led to increased cell death via activation of caspase 3, CBGOA treatment did not impact that pathway, suggesting that other caspase-independent pathways may be implicated. Conclusions This pilot study identifies CBGOA as a candidate cannabinoid with neuroprotective potential in an in vitro model of ischemic stroke. The use of iPSC-derived human cortical neurons strengthens translational relevance, but the modest effects observed, and the limitations of in vitro systems, underscore the need for in vivo validation and further mechanistic studies. Collectively, these results provide a foundation for exploring CBGOA and related cannabinoids as potential neuroprotective agents in stroke
Advancements in electrospinning: a comprehensive review of historical development, key parameters, applications, and challenges
No full textAbstract Electrospinning is a creative and adaptable method for creating nanofibers with a wide range of uses in industries like textiles, filtration, biomedical engineering and others. Beginning with early research in the 1930s and continuing through more recent developments, this review offers a thorough account of the history of electrospinning. A high-voltage power source, a spinneret, and a collector make up the basic electrospinning setup, which we explore in detail along with its basic working principles. Since these factors have a significant impact on fiber morphology and diameter, important electrospinning parameters are covered in detail, including solution viscosity, electric field strength, collector distance, and ambient conditions. Additionally, the review emphasizes the wide range of uses for electrospun nanofibers, such as filtration membranes, scaffolds for tissue engineering, wound dressings, and drug delivery systems. Scalability, process reproducibility, and the requirement for specialized materials are some of the issues that electrospinning faces despite its potential. In conclusion, we present the outlook directions for the method, highlighting possible advancements and uses that can increase its industrial significance and broaden its use in developing domains through solvent-free and 3D electrospinning
Prospective cohort study: vascular clamping of uterine artery combined with sacral ligament plication in complex hysterectomy
No full textAbstract Objective To evaluate the clinical efficacy of the combined technique involving Hem-o-lok clip closure of the uterine artery trunk and uterosacral ligament plication in laparoscopic complex hysterectomy. Methods A prospective study included 100 patients undergoing laparoscopic complex hysterectomy at our hospital from January 2021 to June 2022. Patients were divided into the conventional group (n = 50) and the combined group (n = 50) based on surgical techniques. The conventional group underwent standard electrocoagulation closure of the ascending uterine artery branch at the cervical isthmus level and simple vaginal cuff suture, while the combined group utilized Hem-o-lok vascular clips for early uterine artery trunk closure and additional uterosacral ligament plication fixation to the vaginal cuff. Intraoperative blood loss, operative time, postoperative recovery indicators, and 3-year follow-up outcomes—including pelvic floor function (POP-Q staging, PFDI-20 score) and sexual quality of life (FSFI score)—were compared. Results Compared with the conventional group, the combined group demonstrated significantly reduced intraoperative blood loss (68.7 ± 15.2 vs.95.2 ± 18.4mL, P < 0.001) higher surgical field visibility scores (4.8 ± 0.3 vs. 3.1 ± 0.7, P < 0.01), faster postoperative recovery, and lower hospitalization costs. At 3-year follow-up, the combined group exhibited lower rates of POP-Q stage ≥Ⅱ (6% vs. 24%, P < 0.01), longer vaginal length (8.1 ± 0.8 vs. 7.0 ± 1.2 cm, P < 0.01), lower PFDI-20 scores (18.5 ± 4.5 vs. 35.7 ± 7.8, P < 0.01), and higher FSFI scores (25.2 ± 2.6 vs. 20.3 ± 4.1, P < 0.01). Conclusion T The combined technique of uterine artery trunk closure with Hem-o-lok clips and uterosacral ligament plication significantly improved surgical efficiency without increasing major complications. Furthermore, in this prospective cohort, it was associated with a shorter operative time, less blood loss, and better pelvic floor and sexual function metrics at the 3-year follow-up compared to the conventional technique
HAGLR promotes endometriosis progression via the miR-185-5p/VEGFA axis and serves as a potential diagnostic biomarker
No full textAbstract Background Endometriosis (EMs) is a prevalent gynecological disorder among women of reproductive age. HAGLR has recently been identified as a potential factor in EMs, but its functional role and underlying mechanisms remain unclear. Methods 110 EMs patients and 110 controls were enrolled. The abundance of HAGLR, miR-185-5p, and VEGFA were quantified by qRT-PCR. Pearson correlation, ROC curve analysis, and logistic regression were performed to estimate clinical associations, diagnostic value, and risk factors. Cell proliferation was assessed using the CCK-8 assay, while migration and invasion were examined via Transwell assays. Regulatory interactions were predicted through bioinformatics and validated via dual-luciferase reporter assays and rescue experiments. Results HAGLR expression was significantly elevated in EMs tissues and identified as an independent risk factor with good diagnostic performance for EMs. High HAGLR expression was associated with deep infiltrating endometriosis (DIE) and advanced rASRM stages. Functional assays showed that HAGLR knockdown suppressed proliferation, migration, and invasion of 12Z cells. Mechanistically, HAGLR acted as a molecular sponge for miR-185-5p, as evidenced by their negative correlation. miR-185-5p directly targeted VEGFA, which was found to be upregulated in EMs and positively correlated with HAGLR expression. VEGFA overexpression rescued the inhibitory effects of HAGLR silencing, restoring cell growth and invasiveness. Conclusions HAGLR may be a potential, valuable diagnostic biomarker and therapeutic candidate in EMs. These findings reveal that HAGLR promotes EMs progression by modulating the miR-185-5p/VEGFA axis, contributing to enhanced proliferation and invasion of endometrial stromal cells
Prevalence, antimicrobial resistance, and associated factors of bacterial vaginosis and aerobic vaginitis among women suspected of STIs in Bahir Dar, Ethiopia
No full textAbstract Background Bacterial vaginosis (BV) and aerobic vaginitis (AV) are characterized by an imbalance of vaginal microbiome, becomes a serious public health crisis especially in low and middle income country. Objective To determine the Prevalence, Antimicrobial Resistance (AMR), and Associated Factors of Bacterial Vaginosis and Aerobic Vaginitis among Women Suspected of sexually transmitted infections (STIs) in Bahir Dar, Ethiopia. Materials and methods A facility-based cross-sectional study was conducted among 261 women suspected of STIs at selected health institutions in Bahir Dar City, northwest Ethiopia (February–May 2025). All eligible women were invited to minimize selection bias and ensure broad representation. Data was collected through structured interview, vaginal swab samples were collected and used for Gram stain methods to evaluate BV and AV scores according to the Nugent’s and Donder’s criteria, respectively. In situation of AV cases the aerobic bacterial pathogens and their antibiotic resistance were determined using the Kirby-Bauer disk diffusion method according to Clinical and Laboratory Standards Institute (CLSI) guidelines. Logistic regression was used to assess associations, with results reported as odds ratios (ORs) and 95% confidence intervals (CIs). Variables with a p-value less than 0.05 were considered statistically significant. Results The overall prevalence of bacterial vaginosis (BV) was 20.7% (54/261), while aerobic vaginitis (AV) was 17.2% (45/261), with a dual infection rate of 2.7% (7/261). Among 45 aerobic bacterial isolates, 25 (55.6%) were Gram-positive and 20 (44.4%) were Gram-negative. The most common species were Staphylococcus aureus (13/45, 28.9%) and Escherichia coli (12/45, 26.7%). Gram-positive species showed variable resistance, with 20% classified as MDR. All E. coli and K. pneumoniae isolates were MDR, while P. aeruginosa showed partial resistance; overall MDR prevalence was 49%. The most important factors significantly associated with BV were single marital status, occupation (commercial sex worker, housewife), vaginal pH > 4.5, Donders’ score (moderate to severe), and history of STI or abortion. For AV, key factors included occupation (housewife, commercial sex worker), vaginal burning sensation, vaginal pH > 4.5, positive BV status, and Nugent score indicating BV. Conclusion Bacterial vaginosis and aerobic vaginitis were prevalent among STI-suspected women in Bahir Dar, Ethiopia, with substantial multidrug resistance and significant associations with selected socio-demographic and clinical factors, underscoring the need for improved screening and resistance-guided management
Efficacy and acceptability of dienogest among patients with endometriosis in Thailand
No full textAbstract Background Endometriosis is a chronic condition affecting women of reproductive age and often associated with pain, impaired fertility, and reduced quality of life. Management requires long-term strategies, with medical treatment preferred over repeated surgery. Treatment selection must balance efficacy, cost, patient preference, and safety. Dienogest is a progestin shown to be effective, but real-world data in Thai women remain limited. This study aimed to evaluate the efficacy and safety of dienogest in this population. Methods This single-arm, real-world prospective observational study was conducted at King Chulalongkorn Memorial Hospital, Bangkok, Thailand from April 2024 to May 2025. Women with endometriosis received dienogest once daily for 24 weeks. Baseline symptoms, endometriosis-associated pain, and satisfaction were assessed using a visual analog scale (VAS). Follow-up visits were scheduled at 12 and 24 weeks, with reassessment of pain symptoms, satisfaction, and adverse events. Results A total of 62 participants were included for analysis, with a mean age of 34.2 ± 7.2 years. Dysmenorrhoea was reported by 86.4% and chronic pelvic pain by 60.6% of participants. The mean overall endometriosis associated-pain VAS decreased significantly from 7.5 ± 1.6 at baseline to 2.8 ± 2.2 at 12 weeks and 1.9 ± 1.7 at 24 weeks (p < 0.001). Satisfaction scores were 7.5 ± 1.9 at 12 weeks and 8.1 ± 1.5 at 24 weeks with discontinuation rate of 3 out of 65 women (4.6%). At 12 weeks, common adverse events included acne (29.0%), depressed mood (16.1%), breast pain (14.5%), and headache (14.5%), while weight gain and hot flushes were less common. By 24 weeks, weight gain (26.7%) and acne (26.7%) were most frequently reported. Conclusion Dienogest was associated with reducing pain and good satisfaction in Thai women with endometriosis, with an acceptable safety profile. These findings support its use as a practical long-term management option. Trial registration ISRCTN registration approval number ISRCTN68041248 on 13 March 2024
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