Introduction: Postoperative pain management is of prime importance to the surgeon, as it significantly influences a patient’s recovery. A multimodal approach to pain management is an essential component of postoperative care. Curcumin, a natural antioxidant and anti-inflammatory compound, also exhibits analgesic properties. However, its use in the postoperative setting has not been extensively studied. Aim: To evaluate the role of oral curcumin as an analgesic in the management of postoperative pain following breast cancer surgery. Materials and Methods: This was a single-blind, randomised controlled trial that was conducted in the Department of Surgical Oncology, Cancer Research Institute, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India and included 60 patients undergoing surgery for breast cancer between October 2023 and April 2024. The study group was administered oral curcumin lozenges twice daily, along with standard analgesics, from Postoperative Day (POD) 1. The control group received a placebo. Postoperative pain was assessed from POD 0 to POD 7 using the 11-point Numeric Pain Scale (NPS) and compared using the independent t-test performed with the Statistical Package for the Social Sciences (SPSS) version 25.0. Results: Sixty patients were enrolled (30 in each group). One patient in the study group was excluded from the final analysis as the study protocol was not followed; therefore, 59 patients were analysed. A statistically significant difference in pain scores between the study and control groups was observed on POD 6 and POD 7 (p-value=0.006). No significant difference was observed between the groups regarding the use of SOS analgesics (p-value=0.322) or drain output (p-value>0.05). No adverse events were reported by any patient in the study group. Conclusion: This study demonstrated that curcumin may be beneficial in postoperative pain management. The use of a nutraceutical such as curcumin, with its favourable safety profile and minimal side-effects, offers a promising option. A longer follow-up period is warranted to fully explore the analgesic potential of curcumin. Additionally, studies employing a doubleblind design and larger sample sizes are recommended to provide further evidence of its effectiveness in postoperative pain management.

The perioperative management in adult cardiac surgery patients remains highly variable across centres and regions. The APECx study (Anaesthesia, Perfusion and surgical practicEs in Cardiac surgery) aims to describe the incidence of key clinical patient outcomes, map global variation in anaesthesia, perfusion and surgical practices in cardiac surgery, identify potential modifiable factors associated with relevant clinical outcomes, and explore global, socioeconomic and sex-based differences within these practices. APECx is a prospective multicentre observational study scheduled to start in 2026 that will be conducted in cardiac surgery centres worldwide. Through a modular design, the research focus will evolve over time by going through multiple study phases during a 10-year period. Participating centres can join or leave each study phase and will be actively recruited over the course of the entire study period. Data collection will occur biannually, including all consecutive eligible cases during two prospectively pre-specified locally defined consecutive weeks within a 3-month window. Data will be collected using a web-based electronic case report form. Collected data will be limited to a clearly delineated minimised dataset. All data are routinely obtained as part of standard clinical care. Overall clinical outcomes include, but are not limited to, intensive care unit (ICU) and hospital length of stay, and in-hospital mortality with a maximum follow-up of 30 days. A pilot study will evaluate the feasibility and quantify the workload for participating sites. This study protocol was approved by the Medical Ethics Review Committee of Amsterdam UMC and will be conducted in accordance with local regulations at each participating centre. APECx is a modular, multiphase, large-scale, international, multicentre cohort study with the potential to contribute to standardised, evidence-based care worldwide. By minimising site burden, APECx will allow centres with varying amounts of resources from various economies to join. The modular design uniquely positions it to provide a broad overview of global perioperative practices in cardiac surgery, while enabling detailed investigation of specific evidence gaps.

We report our initial cases of robotic left atrial appendage occlusion (LAAO) device deployment. From June 2021 to December 2024, all consecutive patients undergoing robotic-assisted LAAO (isolated or with robotic-assisted CABG) using an epicardial clip were enroled. The study protocol was approved by the Institutional Review Board (IRB 45CFR164.512). A total of 28 patients were included, 22 of which underwent a concomitant CABG. Transesophageal echocardiogram confirmed excellent exclusion of the LA appendage in all but one patient. There were no postoperative strokes, myocardial infarctions, reoperation for bleeding, unplanned revascularisation, or deaths. At a median of 1.4 [0.9-1.8] years, there was 1 non-cardiac mortality (cancer) and 1 stroke. Nine (32.1%) patients were off OAC, while 21 (75.0%) were off class I-III antiarrhythmic drugs. These early results show optimal stroke prevention outcomes, considering the high-risk level of the patients. Longer follow-up is warranted to confirm these outcomes.

Introduction: Postoperative pain management is of prime importance to the surgeon, as it significantly influences a patient’s recovery. A multimodal approach to pain management is an essential component of postoperative care. Curcumin, a natural antioxidant and anti-inflammatory compound, also exhibits analgesic properties. However, its use in the postoperative setting has not been extensively studied. Aim: To evaluate the role of oral curcumin as an analgesic in the management of postoperative pain following breast cancer surgery. Materials and Methods: This was a single-blind, randomised controlled trial that was conducted in the Department of Surgical Oncology, Cancer Research Institute, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India and included 60 patients undergoing surgery for breast cancer between October 2023 and April 2024. The study group was administered oral curcumin lozenges twice daily, along with standard analgesics, from Postoperative Day (POD) 1. The control group received a placebo. Postoperative pain was assessed from POD 0 to POD 7 using the 11-point Numeric Pain Scale (NPS) and compared using the independent t-test performed with the Statistical Package for the Social Sciences (SPSS) version 25.0. Results: Sixty patients were enrolled (30 in each group). One patient in the study group was excluded from the final analysis as the study protocol was not followed; therefore, 59 patients were analysed. A statistically significant difference in pain scores between the study and control groups was observed on POD 6 and POD 7 (p-value=0.006). No significant difference was observed between the groups regarding the use of SOS analgesics (p-value=0.322) or drain output (p-value>0.05). No adverse events were reported by any patient in the study group. Conclusion: This study demonstrated that curcumin may be beneficial in postoperative pain management. The use of a nutraceutical such as curcumin, with its favourable safety profile and minimal side-effects, offers a promising option. A longer follow-up period is warranted to fully explore the analgesic potential of curcumin. Additionally, studies employing a doubleblind design and larger sample sizes are recommended to provide further evidence of its effectiveness in postoperative pain management.

Comparison outcomes between laparoscopic choledocholithotripsy and laparoscopic cholecystectomy and preoperative endoscopic retrograde cholangiopancreatography with sphincterotomy and laparoscopic cholecystectomy in patients with choledocholithiasis and cholelithiasis: an up-to-date meta-analysis.

Clinical efficacy of Xiaotan Sanjie decoction in treating gastric cancer with peritoneal metastases: A study protocol for a randomized controlled trial.

The current paper describes the protocol for the Hybrid type 1 effectiveness-implementation trial titled Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES). The aims of the MATCHES intervention trial are to promote both colorectal cancer (CRC) and hepatitis C virus (HCV) screening among patients aged 45-75years old receiving primary care at a federally qualified health center (FQHC) who are not currently up-to-date with both screenings and to examine implementation outcomes. Ten health center sites in the FQHC will be randomized in two waves using a stepped wedge design. Intervention strategies target the system, clinician, and patient levels. System-level strategies include a customized electronic health record best practice alert that pairs CRC and HCV screening and standard operating procedures. Clinician-level strategies include a training session and feedback on screening rates. Patient-level strategies include a theory-informed educational booklet about CRC and HCV screening in English or Spanish and access to stool DNA testing and HCV screening among 350 participants. The primary outcome is both CRC and HCV screening uptake at 12months post-intervention among 350 participants. System-wide CRC and HCV screening rates among patients 45-75years old also will be monitored. Implementation barriers and facilitators will be examined. The project is ongoing; effectiveness and implementation outcomes will be determined following study completion. Results may inform potential subsequent scale-up and offer insights for promoting multiple screening behaviors in a single intervention. NCT06745895 (date registered: 2024-12-20); https://clinicaltrials.gov/study/NCT06745895?cond=CRC%20AND%20HCV&rank=.

Myasthenia Gravis (MG) is a rare autoimmune disorder with fluctuating weakness and substantial impact on quality of life (QoL). Despite advances in pharmacological treatment, patients often experience fatigue, anxiety, and reduced daily functioning. Adapted Physical Activity (APA) has shown benefits in chronic neuromuscular disorders, while Art Therapy (AT) has demonstrated positive psychosocial effects in neurological conditions. However, no studies have investigated the potential synergy of APA combined with AT in MG. We designed a monocentric, prospective, randomized crossover pilot trial to evaluate the feasibility and preliminary efficacy of an integrated APA+AT program compared to APA alone. A total of 102 adult patients with MG will be recruited from Lille University Hospital and partner centers. Each participant will undergo two 6-week phases (APA only vs APA+AT), separated by a 46-week washout. Primary outcome is change in QoL (MG-QOL15) at 3months. Secondary outcomes include fatigue (FSS), anxiety and depression (HADS), activities of daily living (MG-ADL), physical function tests, physical activity (IPAQ, accelerometry), and psychosocial outcomes assessed through qualitative methods (interviews, ethnography, creative elicitation). Quantitative data will be analyzed with repeated-measures models; qualitative data will undergo thematic analysis. This trial will be the first to explore a combined APA+AT intervention in MG. By addressing both physical and psychosocial dimensions, the study may provide evidence for integrated, patient-centered care strategies in rare neuromuscular disorders. If feasible and effective, results could inform future multicenter trials and clinical practice. ClinicalTrials.gov Identifier: NCT07125105.

Effectiveness of transoral robotic surgery of the base of the tongue vs. conservative treatment for obstructive sleep apnea, a RCT, the RAPID study protocol.

Previous trials in Africa and Asia, including Bangladesh, showed that community health workers can effectively treat young infants (7-59 days) with fast breathing and children (2-59 months) with chest indrawing pneumonia at home with oral amoxicillin using enhanced integrated community case management (iCCM) protocols. However, the Enhanced Management of Pneumonia in Community (EMPIC), its pneumonia-specific component, has not yet been applied in routine government health systems. Here, we developed a protocol for a feasibility study on the integration of EMPIC into community clinics in Bangladesh through existing government health systems. This study will adopt an implementation research approach that integrates quantitative and qualitative methods. A delivery package will be co-developed with stakeholders to introduce enhanced pneumonia management through government systems in three phases within community clinics of selected upazilas in Kushtia and Dinajpur districts. We will use the plan-do-check-act cycle framework to evaluate implementation, track progress, identify gaps, and test potential solutions. Data collection methods will include health facility assessments, data extractions from routine registers and monthly reports, household surveys, and community follow-ups of under-five children with pneumonia on days 7 and 14 post-treatment. The primary outcome is high (i.e. ≥80%) and effective coverage (i.e. patients receiving the full course of pneumonia treatment) of pneumonia treatment in under-five children. Secondary outcomes include treatment failure rates among under-five children with pneumonia; availability of commodities and supplies for pneumonia management; health worker knowledge, caregiver awareness and care-seeking practices regarding childhood pneumonia; pneumonia prevalence among under-five children; community clinic utilisation for pneumonia-related symptoms by under-five children; and treatment compliance. Our findings may inform the evidence-based scale-up of enhanced pneumonia management in Bangladesh and other low- and middle-income countries, contributing to improved community-level management of childhood pneumonia.

Cardiovascular disease (CVD) is the leading cause of death worldwide. Individuals with lower income or experiencing financial hardship face a significantly higher risk of developing CVD. However, there is a lack of in-depth insight into their experiences with CVD, and specific attention to women is essential. The In a Heartbeat study aims to understand the relationship between CVD and financial hardship and enable earlier recognition and prevention of CVD among both women and men. In this study protocol, we describe our citizen science study, in which we unravel the mechanisms and contexts through which financial problems lead to the development and late recognition of CVD. The main data for this study are collected by citizen scientists through qualitative lifeline interviews. All citizen scientists have experience with financial hardship, and some also have experience with CVD. We hold weekly project team meetings with citizen scientists and professional scientists in which we use methods such as photo elicitation, critical-creative hermeneutic analysis, design thinking, a dynamic learning agenda, and regular individual and group evaluations of the citizen science process. The study was funded in October 2024 and started in January 2025. Data collection started in November 2025 and is expected to end halfway through 2026. Four qualitative lifeline interviews had been conducted as of December 6, 2025. Data analyses are planned for 2026. Manuscripts reporting findings on the central research question and the process evaluations will be submitted for publication in 2027. Toward the end of the study in 2027, we will develop and disseminate concrete recommendations for various stakeholders to prevent CVD and recognize CVD earlier among people with financial hardship. In all our analyses and recommendations, we will consider sex and gender differences. Our study could contribute to a reduction in health inequalities.

Immune checkpoint blockades (ICBs), particularly PD-1 pathway blockades, have significantly improved outcomes in advanced renal cell carcinoma (RCC). However, long-term ICB therapy imposes substantial financial and toxicity burdens. Retrospective data suggest that treatment responses plateau around 24weeks, and some patients maintain disease control even after ICB pause. We initiated a multi-institutional, open-label, randomized controlled trial to confirm the non-inferiority of pausing PD-1 pathway blockade to its continuous administration in patients with advanced clear cell RCC without disease progression. The primary endpoint is overall survival and the secondary endpoint includes time to failure of strategy, progression-free survival, and adverse events. Conducted by the Urologic Oncology Study Group of the Japan Clinical Oncology Group (JCOG), this phase III trial was approved by Certified Review Board in February 2020, with patient enrollment beginning in July 2020. The trial is registered in the Japan Registry for Clinical Trials (JCOG1905; jRCT1031200071).

Study protocol for a theory-informed randomized controlled trial of a lifestyle and sleep intervention to improve quality of life and physical activity in inactive adults: the SleeP exercIse nutRition heALth+ SPIRAL+ study.

MISAPSY: childhood maltreatment, food insecurity, psychological distress and professional integration among socioeconomically disadvantaged young adults - a mixed-methods study protocol.

Although the number of frozen-thawed blastocysts transfer is increasing worldwide, the live birth rate following blastocyst transfer using assisted reproductive technology remains at 30-60%. Thus, improving the pregnancy rate per transfer is an urgent issue. In a previous retrospective study, we evaluated the use of granulocyte-macrophage colony-stimulating factor (GM-CSF)-containing medium for recovery culture to improve the outcomes of frozen-thawed blastocyst transfers. The results demonstrated that the live birth rates increased by approximately 10% following recovery culture in the GM-CSF-containing culture medium. This study aims to prospectively evaluate whether GM-CSF-containing blastocyst recovery culture following thawing increases live birth. This is a multicenter, randomized, parallel-group, active-controlled, single-blind trial. The recruitment target is 750 participants meeting the criteria. Enrolled patients are randomized 1:1 to the GM-CSF-containing culture medium group (test group) or the non-GM-CSF-containing culture medium group (control group). The blastocyst recovery culture after warming was defined as an intervention in this study; frozen-thawed blastocysts will be cultured for 3-7h in GM-CSF-containing medium (test group) or medium without GM-CSF (control group) followed by blastocyst transfer. The primary outcome will be live birth. We will also evaluate embryo transfer outcomes as secondary efficacy endpoints and evaluate perinatal and neonatal outcomes as a safety endpoint. This is the first large-scale prospective study to investigate the efficacy of a GM-CSF-containing medium for frozen-thawed blastocyst transfer. The study findings will provide evidence regarding the efficiency of GM-CSF-containing medium for blastocyst recovery culture after warming. Japan Registry of Clinical Trials jRCT1040240159. Registered on January 6, 2025.

BackgroundNonspecific low back pain (NSLBP) is a leading cause of disability, and effective non-pharmacological treatments remain limited. Traditional Chinese Exercises (TCE) are increasingly used for NSLBP, but their effectiveness has not been fully established.ObjectiveTo evaluate the effects of Traditional Chinese Exercises on pain, functional disability, and trunk muscle endurance in patients with nonspecific low back pain.MethodsA systematic review and meta-analysis of randomized controlled trials was conducted according to PRISMA guidelines. Chinese and English databases were searched up to 2025. Pain, disability, and trunk muscle endurance were synthesized using random-effects models.ResultsEighteen randomized controlled trials involving adults with NSLBP were included. Traditional Chinese Exercises were associated with improvements in pain, functional disability, and trunk muscle endurance compared with control interventions. Higher intervention frequency and shorter duration were associated with greater effects, although heterogeneity was substantial.ConclusionTraditional Chinese Exercises may improve pain, function, and trunk muscle endurance in patients with nonspecific low back pain. However, due to heterogeneity and methodological limitations, the findings should be interpreted with caution.Trial registrationThe study protocol was registered in PROSPERO, the international prospective register of systematic reviews, under registration number CRD42025632131.

The effects of theta-burst stimulation (TBS) and repetitive transcranial magnetic stimulation (rTMS) on the motor symptoms in Parkinson's disease (PD) were evaluated using a network meta-analysis (NMA). Studies (1 January 2003-1 January 2025) from four databases were screened for analyses. A Bayesian NMA model was employed, and the surface under the cumulative ranking curve (SUCRA) was used to predict the efficacy ranking of each intervention. The study protocol was registered on the International Prospective Register of Systematic Reviews platform (Identification number: CRD42025646363). A total of 28 randomized controlled trials were included. Subgroup analysis showed that multi-session cTBS was significantly superior to single-session cTBS in improving motor symptom. The main analysis (23 studies with multi-session protocols) revealed that, compared with sham stimulation, high-frequency (HF) rTMS-stimulating primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) and cTBS-stimulating supplementary motor area (SMA) significantly improved global motor function, ranking first and second in SUCRA values, respectively. For specific symptoms, HF + SMA showed the best improvement in Freezing of Gait Questionnaire and time up and go test (SUCRA: 0.774 and 0.982, respectively), low-frequency stimulating SMA ranked first for improving bradykinesia (SUCRA = 0.944), and HF + M1 significantly improved quality of life. All interventions were well tolerated. Multi-session TBS protocols are superior to single-session protocols. HF + M1 + DLPFC and cTBS + SMA represent the most promising protocols for improving global motor function in PD. For different motor symptoms, corresponding target-specific stimulation should be prioritized.

Even though commercially available assays can diagnose dengue fever at the point of care, no prognostic biomarkers accurately predict the possibility of severe dengue. Predictive biomarkers may lower dengue-associated morbidity and mortality by timely management. A systematic review and meta-analysis were performed to analyze the predictive value of clinically relevant biomarkers of severe dengue. The study protocol was designed based on updated PRISMA guidelines. An electronic search of PubMed/MEDLINE, Scopus and Embase was carried out using specific search terms for articles analysing clinically significant biomarkers of dengue across all age groups between January 2000 and June 2025. The meta-analysis component was modified to synthesize the pooled area under the curve (AUC) of ROC (Receiver Operating Characteristic) with a 95% confidence interval (CI). Eleven cross sectional studies reporting AUC of ROC curve with 95% confidence interval, of nine biomarkers in serum samples from Thailand, India, Mexico, and Sri Lanka were qualified for the quantitative synthesis. The overall pooled AUCROC curve value of selected biomarkers was 0.86 (95% CI 0.81-0.90). The pooled AUCROC curve value of serum ferritin was 0.88 (95% CI 0.82-0.95). This meta-analysis concludes that elevated serum ferritin levels within the initial 4-5 days of fever among dengue patients predict progression to severe dengue.

People with body mass index (BMI) ≥35 kg/m2 have an approximately 19-fold increased risk of undergoing total knee replacement (TKR); however, many UK integrated care boards (37%) have restrictive policies which limit access to TKR for people based on BMI. Therefore, access to both surgical and non-surgical treatments varies widely, exacerbating existing health inequalities. It remains unclear how decisions about offering TKR are made in people with severe knee osteoarthritis, which weight-loss interventions are provided in practice and how different management pathways relate to patient outcomes among individuals with high BMI. This study will recruit 400 participants with severe Kellgren-Lawrence grade four knee osteoarthritis from eight secondary care centres in England. All participants, irrespective of BMI, will provide baseline clinical data and patient-reported outcome measures (PROMs), enabling characterisation of baseline associations between BMI, knee function and body image.A prespecified subgroup of participants with BMI ≥35 kg/m2 (minimum n=105) will undergo longitudinal follow-up at 6 months, 12 months and 24 months, including repeat BMI measurement, PROMs and detailed data on access to surgical and non-surgical interventions, including weight-loss strategies and TKR. For those with BMI ≥35 kg/m2, statistical modelling will be used to explore associations between baseline factors and longitudinal outcomes including Oxford Knee Score and weight change at 12 months (n≥105). Structural equation modelling will be used to quantify associations between BMI and knee pain/function mediated by psychosocial factors using data from all participants (n=400). A nested qualitative study of surgeons and patients will explore obstacles and preferences in the management of severe knee osteoarthritis. The study received ethical approval from the West of Scotland REC 5 (Ref: 24/WS/0146) on 10 October 2024. Results will be disseminated through peer-reviewed publications. ISRCTN42984928.

The institutionalisation of older adults has become increasingly common in Sri Lanka due to recent socioeconomic changes. Tai Chi is a traditional Chinese martial art that provides numerous physical and psychological health benefits. Despite its proven effectiveness, Tai Chi is a relatively new intervention in Sri Lanka, with no local research on its feasibility and efficacy among older adults. This study aims to evaluate the feasibility and effectiveness of Tai Chi on physical function and fall risk, lung function, depression, pain and health-related quality of life (HRQOL) in older adults residing in aged care homes in Sri Lanka. A single-arm pretest-posttest feasibility study will be conducted among older adults aged 60 and over (n=40) living in aged care homes in Kandy District, Sri Lanka. A certified Tai Chi instructor will deliver two 60 min sessions of the Tai Chi for Arthritis and Fall Prevention programme per week over a 12-week period in aged care home settings. Acceptability, demand, implementation, practicality, adaptation, integration, expansion and study limitations will be assessed to determine feasibility. Baseline and post-12-week Tai Chi programme outcomes will be assessed, focusing on physical function and fall risk, lung function, pain, depression and HRQOL. Additionally, field notes will be taken during the intervention, and a post-intervention follow-up group discussion will be conducted. Paired t-tests will be used to assess the effectiveness of the Tai Chi programme. A narrative synthesis will be used to analyse qualitative data. The Research Ethics Committee of the Faculty of Medicine, University of Peradeniya, Sri Lanka, approved this study (No.: 2024/EC/34). Written informed consent will be obtained from each participant before data collection. The findings will be presented at national and international research conferences and published in a reputed journal. This study was registered with the Sri Lanka Trial Registration (SLCTR/2025/025) at https://slctr.lk/trials/slctr-2025-025 (date: 26 June 2025).