Type 2 diabetes mellitus has been associated with an increased risk of cognitive decline and dementia, with patients being 1.5–2 times more likely to develop these conditions. While both sodium-glucose co-transporter 2 (SGLT2) inhibitors and thiazolidinediones (TZDs) have shown potential neuroprotective effects in previous studies, their comparative effectiveness for preventing neurodegenerative outcomes has not been established. This study aimed to compare the risk of stroke, dementia and Alzheimer’s disease (AD) between patients treated with SGLT2 inhibitors and those treated with TZDs.
Multicentre, retrospective, observational, new-user, active-comparator cohort study.
Electronic health record-based databases from 11 secondary and tertiary institutions in South Korea from 1 January 2014 to 31 July 2025. The study period began in 2014, following the post-marketing surveillance initiation of SGLT2 inhibitors in Korea (November 2013), to ensure adequate drug availability and clinical adoption.
Patients aged 40 years or older who were newly prescribed either SGLT2 inhibitors or TZDs without prior exposure.
Propensity score matching (1:1) was performed using sex as the primary covariate due to data availability constraints in the Observational Medical Outcomes Partnership Common Data Model framework. The HRs with 95% CIs were measured via Cox regression analysis.
The study analysed 24 172 matched pairs for stroke outcomes (40 483 person-years in the SGLT2 inhibitor group and 39 363 person-years in the TZD group), 25 111 matched pairs for dementia (41 924 person-years in the SGLT2 inhibitor group and 40 726 person-years in the TZD group) and 25 237 matched pairs for AD (42 139 person-years in the SGLT2 inhibitor group and 40 895 person-years in the TZD group) across 11 participating hospitals. After a 1:1 propensity score matching, the SGLT2 inhibitors showed no significant difference in stroke risk (HR 1.18, 95% CI 0.62 to 2.23, p=0.62), while having significant reductions in dementia risk (HR 0.66, 95% CI 0.45 to 0.98, p=0.04) and AD risk (HR 0.54, 95% CI 0.35 to 0.83, p=0.005). Moreover, these protective effects for neurodegenerative outcomes were shown to be consistent across multiple hospital sites.
SGLT2 inhibitors are associated with a reduced risk of dementia and AD compared with TZDs in patients aged 40 years or older with type 2 diabetes and have neutral effects on stroke risk. These findings confirm the potential selective neuroprotective benefits of SGLT2 inhibitors for neurodegenerative outcomes, which may inform therapeutic decision-making for diabetic patients at risk of cognitive decline.
Current evidence is unclear due to methodological limitations. We bridge critical knowledge gaps by quantifying the longitudinal changes in movement behaviours and their correlates from early childhood through adolescence.
Longitudinal observational cohort study.
General healthy child and adolescent sample in Singapore.
Growing Up in Singapore Towards healthy Outcomes study participants.
We used wrist-worn accelerometry and proxy-reported data to examine movement behaviours (sleep, inactivity, light physical activity (PA; LPA) and moderate-to-vigorous PA (MVPA) and screen-viewing) at ages 5.5, 8, 10 and 12 years and the sociodemographic and maternal lifestyle-related correlates using linear regression models with generalised estimating equations.
Among 837 children, sleep, LPA and MVPA declined by 3% (from 9.1 to 8.8 hours/day), 24% (from 5.8 to 4.4 hours/day) and 44% (from 71.3 to 40.1 min/day), respectively, while inactivity and screen viewing increased by 26% (from 8.0 to 10.1 hours/day) and 155% (from 1.8 to 4.6 hours/day), respectively, from ages 5.5 to 12 years. The greatest annual increase in inactivity (0.6 hour/annum) and screen-viewing (0.8 hour/annum) and decrease in LPA (0.3 hour/annum) and MVPA (10.4 min/annum) occurred from ages 8 to 10 years. Girls of Malay ethnicity and lower socioeconomic status, and whose mothers had less favourable movement behaviours, had significantly less sleep, higher inactivity and screen-viewing and/or lower PA. Maternal PA levels and/or sitting time were associated with children’s sleep, inactivity and MVPA up to age 8 years, while maternal sitting and screen-viewing behaviours were associated with children’s screen-viewing at all ages.
Using contemporaneous datasets relevant to the present day, we confirmed that children become less physically active and have longer screen-viewing as they transition into adolescence and highlighted characteristics to be prioritised in future interventions.
Interstitial lung diseases (ILD) associated with an underlying connective tissue disease (CTD), also known as a systemic autoimmune rheumatic disease or SARD, are chronic conditions with a tendency to progress. CTD-ILDs are increasingly diagnosed and pose an important global health challenge. This systematic review aims to provide an overarching evaluation of their epidemiology and disease burden in Asia. In this review, the term CTD-ILD will be used to denote all major forms of ILD arising in the context of a SARD.
This systematic review will adhere to the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including a flow diagram to depict the process by four independent reviewers that will assess titles and abstracts against the following predetermined criteria. A systematic review of the literature search published from 2000 to 2024 will be conducted using five electronic databases including PubMed/MEDLINE, Scopus, EMBASE, Cochrane Library and Web of Science. Publications that meet the inclusion criteria of this review will be subjected to a full-text review to extract relevant data. Collated data will be analysed and organised into categories based on the expected outcome and objectives. The quality of published evidence, including heterogeneity across studies, will be checked against PRISMA checklists and assessed by Newcastle-Ottawa Scale.
Ethics approval is not applicable for this study since no original data will be collected. The findings of this review will be disseminated through a peer-reviewed publication in a scientific journal and conference communications, with the aim of contributing insights to the field by identifying research gaps and informing clinical practice.
The protocol of this systematic review is registered with the National Medical & Research Register (ID-24–03600-GUB) and International Prospective Register of Systematic Reviews PROSPERO (CRD420251037095).
Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.
The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.
The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.
To adapt the Serious Illness Conversation Guide (SICG), Ariadne Labs, Massachusetts USA, to a local Singapore version and evaluate its acceptability.
Qualitative study using semistructured interviews.
49 participants (30 patients with serious illnesses, five family caregivers and 14 healthcare providers (HCP)) recruited from three public hospitals in Singapore.
Face-to-face or virtual indepth interviews.
Guided by the Heuristic Framework and Cultural Sensitivity model, we employed a multi-stage iterative design. Starting with the original SICG, we iterated the guide following three rounds of cognitive interviews among patients followed by expert consultation (n=4) to derive a local version, subsequently reviewed by caregivers and HCP. We assessed acceptability of the SICG using traffic light colour codes—red (unacceptable), orange (needs change) and green (no change) and gathered suggestions to rephrase them. Using content analysis, we compared acceptability of questions as proportion of red, orange and green responses at each interview round and inductively derived themes reflecting views towards the guide.
The original SICG showed low acceptability, and most questions received high proportions of red responses. Negative words and phrases dampening hope, lack of comprehension due to complex framing and cultural insensitivity to prognostic discussions were key themes reflecting low acceptability. Surface and deep structural revisions that centred around positive framing with hopeful language, focusing on current values and individualising conversations (‘use if appropriate’ prompts) significantly improved the guide’s acceptability.
We derived a local Singapore SICG that aligns with the core elements of the original guide and fosters cultural sensitivity. The adapted version could be further tested in other Asian countries.
Despite growing concerns regarding the impact of smartphone use on adolescents' lifestyle, there is a notable lack of studies utilising national data to explore how smartphone use influences eating habits in this age group. We aimed to investigate the association between smartphone screen time and fast food intake using representative data from Korean adolescents.
Cross-sectional survey.
This cross-sectional analysis used data from the 2017 Korean Youth Risk Behavior Web-based Survey (KYRBS). We used Poisson regression to directly estimate prevalence ratios (PRs) rather than using logistic regression as odds ratios (ORs) tend to overestimate PRs when the outcome is common. Smartphone screen time was categorised into four groups based on the daily time spent using smartphones:
Data from 39 753 individuals were included.
The primary outcome was the frequency of fast food intake, assessed via a self-reported survey that asked: "In the past 7 days, how often did you eat fast food such as pizza, hamburgers, fried chicken, or drink carbonated beverages?". Participants were categorised into two groups based on their median intake: infrequent (≤2 times/week) and frequent (≥3 times/week).
Among 39 753 adolescents, 19 273 reported frequent fast food intake (10 162 (51.9%) boys, 9111 (45.1%) girls), while 20 480 reported infrequent intake (9409 (48.1%) boys, 11 071 (54.9%) girls). The probabilities that adolescents who used smartphones for 6 hours daily would have frequent fast food intake were 1.29 times (95% CI: 1.28 to 1.30) among boys, and 1.43 times (95% CI: 1.42 to 1.44) higher among girls, compared with adolescents who used smartphones for 2 hours daily.
The association between prolonged smartphone screen time and frequent fast food intake in adolescents suggests the need for targeted interventions addressing digital media use to promote healthier eating behaviors.
Diabetic foot ulcers (DFUs) are highly prevalent and recurrent complications of diabetes mellitus that have significant health and cost implications. Self-care is critical for preventing or delaying DFU and promoting healing, yet adherence to self-care recommendations is low. Interventions using motivational interviewing (MI) have been effective in supporting behaviour change and emotional adjustment, but evidence for DFU is scarce. This study will assess the acceptability, feasibility and preliminary efficacy of an MI-guided programme, Healing DFU through Empowerment and Active Listening (HEALing), and its integration in usual wound care practice.
This single-arm pilot study adopts a mixed-methods approach to assess the feasibility and acceptability of the HEALing intervention. HEALing is a practical, low-intensity, clinic-integrated personalised self-care support intervention, comprising three 30 min face-to-face sessions delivered over 6 weeks by trained wound care nurses, aiming to enhance self-care behaviours and support emotional adjustment in patients with DFU. Data will be collected from a battery of questionnaire-based surveys with patients (n=30), and in-depth individual interviews with both patients (n=30) and wound care nurse facilitators (n=10) from nurse-led wound clinics in a large primary care sector in Singapore.
The primary feasibility outcomes will include enrolment, retention (≥80%), data completion (≥80% of surveys) and participant satisfaction. Secondary outcomes will include self-report measures of illness perceptions, foot care confidence, diabetes distress, foot self-care behaviour, DFU knowledge, autonomy support and health-related quality of life, taken at baseline and post-intervention. Post-intervention interviews with patients and wound care nurse facilitators will be conducted to collect feedback on the programme and its implementation feasibility.
The study protocol has been approved by the local ethics committee, and written informed consent will be obtained from all participants. Findings will be disseminated through the first author’s PhD thesis, peer-reviewed journals, national and international conferences and public events.
Stroke is a leading cause of disability and mortality worldwide, with upper limb dysfunction being among its most common effects. Compression therapy has recently gained growing interest as an adjunct to other rehabilitation interventions for managing upper limb dysfunction among stroke survivors. However, the evidence for its effectiveness remains inconsistent and equivocal. Therefore, this systematic review aims to assess the effectiveness of compression therapy in managing upper limb dysfunction in patients with stroke.
A systematic search of databases (PubMed, Scopus, Web of Science, CINAHL, Cochrane Library, Embase, PEDro, OTseeker, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform) will be conducted to identify peer-reviewed studies and relevant grey literature on compression therapy on upper limb dysfunction after stroke. Two reviewers will independently screen, select and extract data, with discrepancies resolved through discussion or involvement of a third reviewer. Outcomes of interest include clinical measures of upper limb function, activity, participation and safety (ie, adverse effects). Risk of bias will be assessed using the Cochrane RoB 2 for randomised studies, the Risk Of Bias In Non-randomised Studies of Interventions for non-randomised studies. The certainty of evidence across types of compression therapy and outcomes will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation approach. Data will be narratively synthesised, and a meta-analysis will be performed if feasible. The review will be reported following the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines and will be conducted from September 2025 to December 2025.
This systematic review does not require ethical approval as only secondary data will be used. This review will synthesise the body of evidence on the effectiveness of compression therapy in managing poststroke upper limb dysfunction. Results will then be disseminated through a peer-reviewed publication to inform research and clinical practice.
CRD42024625815.
Chronic pain is a common health condition that significantly impacts the quality of life of those affected, affecting one in five people in Canada. The prevalence of this condition tends to increase with age, making it a major health issue given the ageing population. However, its management remains inadequate and requires significant mobilisation of healthcare professionals as well as the development of multiple therapeutic solutions. Among these, non-pharmacological interventions such as hypnosis and virtual reality have proven effective. Nevertheless, while the existing literature seems promising, it presents methodological limitations. Therefore, this study aims to assess the effectiveness of an intervention combining virtual reality and hypnosis in an ageing population suffering from a widespread chronic pain condition, that is, hand arthritis.
This study will be a single-centre randomised clinical trial. Participants will be randomly assigned to one of two conditions: one receiving an intervention combining virtual reality and hypnosis, and the other receiving only virtual reality. The effectiveness of the intervention on current perceived pain before and after the intervention (primary outcome) will be evaluated. Secondary outcomes will include anxiety and depressive symptoms, quality of life, relaxation and fatigue. Exploratory analyses will also be conducted to contribute to the emerging literature by examining physiological variables such as heart rate variability, respiratory rate and electrodermal activity during the intervention, and their relationship with primary and secondary outcomes.
The project was approved by the Research Ethical Committee of the Hospital Maisonneuve-Rosemont (Project no 2024-3539). Participants will be asked to provide written consent for their participation. Results from this study will be shared through peer-reviewed publications, as well as oral and poster presentations at scientific events. The protocol for this study was preregistered on Open Science Framework and raw anonymised data will be available on this platform (https://osf.io/vbh72/?view_only=1d17c5708f894faab6669d85e1fde75d).
Multiple sclerosis (MS) is a common autoimmune illness that causes inflammation, demyelination and neurological damage. Symptom relief and immunotherapy are part of the treatment, but several healthcare barriers significantly influence outcomes and quality of life.
This study aimed to assess different aspects among patients with MS, such as their knowledge of the disease, access to care, medications’ beliefs and depression, and to evaluate any correlations between these variables and their impact on the presence of depression.
A cross-sectional study was conducted from May 2024 to October 2024 at Al-Basheer Hospital, King Abdullah University Hospital (KAUH), Princess Basma Teaching Hospital and the Multiple Sclerosis Society of Amman. 200 participants were recruited after confirming consent. Data were collected through face-to-face interviews using validated instruments, covering sociodemographics, beliefs about medicines, knowledge about MS, access to care and levels of depression.
This study involved 200 patients with MS with a median age of 36 years, mostly women (70.5%), non-smokers (65%) and insured (77.5%). The majority had high education (58%) but low income (67%), with a mean duration of MS disease of 7.8 years after diagnosis. The majority (79.5%) were unaware of their MS type. Beliefs about medications varied, with 22% accepting, 48.5% ambivalent, 14.5% sceptical and 15% indifferent. Disease knowledge was high, with patients recognising MS as an immune, non-contagious and non-curable disease that affects women more than men. Despite good access to care, a percentage of patients needed to travel long distances for care. Depression affected 58% of participants, and it was influenced by access to care, concerning beliefs, income and education. Other variables such as gender, health insurance, the duration of the disease and the necessity of medications had no significant influence.
In conclusion, patients with MS deal with various challenges, such as difficulties in accessing care, associated with psychological factors such as depression. Addressing these barriers by optimising patients' beliefs about medications, enhancing access to care and focusing on the level of knowledge of the disease is crucial for ensuring better and optimal treatment outcomes, as well as decreasing the risk of depression development.
Although low-density lipoprotein cholesterol (LDL-C) is established as the primary cardiovascular disease (CVD) risk factor, some individuals with LDL-C within desirable limits still develop coronary artery disease (CAD). Lipoprotein(a) (Lp(a)) has emerged as a genetically determined independent risk factor for CVD. This study aims to investigate Lp(a) by determining its association with coronary artery stenosis severity, identifying its ethnic-specific genetic determinants and assessing its relationship with an energy-dense dietary pattern.
The PUTRA-CV study is a 3-year, multicentre, case-control observational study involving adult patients who have undergone coronary angiography. The primary outcome is the association between Lp(a) levels and the severity of angiographic CAD (assessed by Gensini or Syntax score). Secondary outcomes include the frequencies of Lp(a)-associated single nucleotide polymorphisms (SNPs) (rs10455872 and rs3798220) and the association between dietary patterns and Lp(a) levels. Lp(a) will be measured using a particle-enhanced immunoturbidimetric method, and SNPs will be genotyped using high-resolution melting. Dietary intake will be assessed using a validated semiquantitative food frequency questionnaire. Data will be analysed using SPSS. Descriptive statistics will be used to summarise population characteristics. Bivariate analyses will use chi-square (2), independent t-tests or Mann-Whitney U tests as appropriate. The independent association between Lp(a) and coronary artery stenosis severity will be determined using multivariable logistic regression, adjusting for confounders. Empirically driven dietary patterns will be derived using reduced rank regression, and their association with Lp(a) will be assessed. For genetic analysis, allele frequencies of the LPA SNPs rs10455872 and rs3798220 will be calculated and compared between cases and controls.
Ethical approval has been obtained from the ethics committees of the Ministry of Health Malaysia (NMRR ID-24-00877-2ID-IIR), Universiti Putra Malaysia (JKEUPM-2024–246), Universiti Teknologi MARA (REC/07/2024-OT/FB/2) and Universiti Malaya Medical Centre (MREC ID NO: 2 02 453–13692). The findings will be disseminated via peer-reviewed journals and conferences.
This study aimed to determine the association between diabetes mellitus (DM) medication use and glycaemic control.
This was a retrospective diabetes registry-based cohort study.
Singapore.
Patients aged 18 and above with incident DM in the SingHealth Diabetes Registry from 2013 to 2020 were included. The entire study period included a 1 year baseline period, a 1 year observation period and a 3 month outcome period.
Drug use was measured using the proportion of days covered (PDC), and the changes in glycated haemoglobin (HbA1c) between the outcome and baseline periods were assessed. The associations between baseline HbA1c and PDC ≥0.80 and between PDC and change in HbA1c were analysed using logistic regression and the Kruskal–Wallis test, respectively.
Of 184 646 unique patients in the registry from 2013 to 2020, 36 314 met the inclusion and exclusion criteria and were included in the analysis. The median PDC for any DM drug, oral DM drugs and insulin during the observation period was 20.3%, 16.8% and 0%, respectively. Those who had good glycaemic control at baseline were less likely to receive DM drugs and those with poor baseline glycaemic control or missing baseline HbA1c were more likely to be consistent users (PDC >80%) (px 10-16).
The relationship between DM drug use and glycaemic control is complex and non-monotonic. Higher PDC for any DM drug and oral DM drugs during the observation period was significantly associated with clinically relevant HbA1c improvements.
The study aims to assess the magnitude of acute gastroenteritis and associated factors among under-five children visiting public hospitals in Jigjiga City, Somali Region, Ethiopia.
A hospital-based cross-sectional study design was used to carry out the study. We then employed a systematic random sampling technique through face-to-face interviews to gather the data. A structured questionnaire consisting of socio-demographic, behavioural, environmental and clinical factors was developed after reviewing relevant literature.
The study was conducted in public hospitals located in Jigjiga City, Somali Region, Ethiopia.
A total of 353 under-five children visiting public hospitals were involved in the study.
The primary outcome of the study was the prevalence of acute gastroenteritis.
The 2-week prevalence of acute gastroenteritis among under-five children was 24.6% (95% CI 23.4% to 25.9%). The study found strong links between acute gastroenteritis and having a household greater than five (adjusted OR (AOR)=2.94, 95% CI 1.55 to 5.60), an unprotected source of drinking water (AOR=2.74, 95% CI 1.29 to 5.82), unimproved latrine facilities (AOR=3.15, 95% CI 1.26 to 7.78), the presence of faeces around the latrine (AOR=3.53, 95% CI 1.77 to 7.03) and mothers or caregivers’ history of diarrhoea over the past 2 weeks (AOR=6.23, 95% CI 3.22 to 12.06).
The overall prevalence of acute gastroenteritis in Jigjiga City was relatively high in the 2-week period. Having a household greater than five, an unprotected source of drinking water and unimproved latrine facilities was a significant predictor of acute gastroenteritis. Additionally, the presence of faeces around the latrines and the history of diarrhoea in mothers or caregivers over the past 2 weeks were strongly linked to acute gastroenteritis.
The goal of the study was to determine the magnitude and contributing factors of low back pain among primary school teachers in Borama Town, Somaliland.
An institution-based descriptive cross-sectional study design was employed. Simple random sampling was used to select the study units from each school.
The study was conducted in Borama, Somaliland.
A total of 268 primary school teachers participated in the study.
The primary outcome of the study was the prevalence of low back pain.
The study found that 51.5% of school teachers had low back pain. There was a strong link between low back pain and having a higher Body Mass Index (adjusted OR (AOR)=2.63) and stress at work (AOR=3.34). Sleep disturbance (AOR=1.73), lifting heavy materials (AOR=1.67) and a history of low back injury (AOR=2.12) were also significant predictors of low back pain.
More than half of primary school teachers had low back pain over the past 12 months. Higher Body Mass Index, history of low back injury, stress at work, lifting heavy material and sleep disturbance were significant and independent predictors of low back pain among primary school teachers.
Temporomandibular disorders (TMDs) are a group of conditions affecting the temporomandibular joint (TMJ), masticatory muscles and associated structures, often leading to pain, dysfunction and a significant impact on quality of life. Epidemiological studies have estimated that up to 75% of the population in the USA exhibits at least one sign of TMD. Although conservative treatments, such as acupuncture and occlusal splints, have been recommended, evidence for their effectiveness remains inconclusive, and the combined effects of these interventions are not well understood.
This study aims to evaluate the efficacy of an intraoral balance appliance (IBA) combined with standard Korean medicine care, compared to Korean medicine care alone, in patients with chronic, painful TMD with myalgia.
A single-centre, two-arm, parallel, practitioner-blinded and evaluator-blinded, randomised controlled trial with a 1:1 allocation ratio will be designed to test the interventions. 76 patients with TMD with myalgia will be recruited and randomised. The interventions will include manual acupuncture and physical therapy for both groups, with the addition of IBA in the treatment group for 3 weeks. The primary outcomes of the study will be the Numeric Rating Scale (NRS) for pain and discomfort at the final visit at week 4. Secondary outcomes will include overall functional assessment of the TMJ using several scales, as well as evaluations of quality of life, patient satisfaction and
The recruitment started on 18 July 2024, and 37 patients were included as of 8 July 2025.
Ethical approval is obtained from the Kyung Hee University Korean Medicine Hospital Institutional Review Board (IRB number: KOMCIRB 2023-06-001). The result from this study will be actively disseminated through manuscript publications and conference presentations.
The protocol was registered with the Clinical Research Information Service (CRiS), Republic of Korea, on 30 October 2023, CRiS number KCT0008906 prior to the initiation of the study, and was revised on 7 July 2025 (https://cris.nih.go.kr/cris/search/detailSearch.do?seq=30270&search_page=M&search_lang=&class_yn=).
For patients with perihilar cholangiocarcinoma (pCCA), surgical resection remains the sole treatment modality that can potentially result in cure. Unfortunately, the majority of patients present with unresectable tumours or are excluded from surgical treatment due to complications like cholangitis affecting their performance status. In the Netherlands, recommended first-line treatment for patients with unresectable pCCA is palliative chemotherapy with gemcitabine and cisplatin. This regimen yields an estimated median overall survival (OS) of 11.7–15.2 months, highlighting the urgent need for novel treatment options. The STRONG I trial, a phase I study in patients with unresectable pCCA, was completed in 2020. Its aim was to assess the feasibility and toxicity profile of adding stereotactic body radiation therapy (SBRT) to chemotherapy. SBRT, delivered in 15 fractions of 4.0 Gray (Gy), was considered to be feasible and safe, with no dose-limiting toxicity being observed. The 1-year local tumour control rate was 80% and the 1-year OS rate 100%, with maintenance of quality of life (QoL). These results encouraged us to initiate the STRONG II trial, aiming to investigate the efficacy of adding SBRT to chemotherapy in a larger patient cohort.
STRONG II is a single-arm, multicentre phase II study. Patients with non-metastatic unresectable pCCA (T1-4, N0-2) are eligible. A total of 30 patients will be enrolled in six academic centres in the Netherlands and two in Belgium. SBRT will be delivered in 15 fractions of 4.0–4.5 Gy. The primary endpoint is local tumour control, defined by Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1. Secondary endpoints include toxicity, biliary stent-related events, progression-free survival, OS and QoL using the EuroQoL five-dimensional, five-level (EQ-5D-5L) questionnaire, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) and the EORTC Biliary Module (QLQ-BIL21). In addition, we will explore the predictive value of the peripheral immunological status (immune-related proteins and serum functional immunological status assay) and its dynamics in determining survival outcomes. For this explorative translational study, two blood samples will be collected, one before the start of chemotherapy and another after completing chemotherapy.
Approval of the study was obtained on 5 June 2024 by the Medical Ethics Review Committee of Erasmus Medical Center Rotterdam, the Netherlands (ID: NL86210.078.24). The anticipated time frame for patient enrolment is July 2024 to December 2027. The main study findings will be published in peer-reviewed medical journals, and presented at national and international conferences.
NCT06493734 (ClinicalTrials.gov).
This study aims to assess the level of cardiovascular disease (CVD) risk and its associated determinants among hypertensive patients in Jigjiga, Somali Region, Ethiopia using the WHO 10-year CVD risk score.
An institution-based cross-sectional study design was employed.
Hypertensive patients aged 40–74 years in two public hospitals in Jigjiga, Somali Region, Ethiopia, from 20 December 2023 to 20 February 2024.
Randomly selected 344 hypertensive patients aged 40–74 years with a duration of 1 year or more from the time of diagnosis and at least having 6-month follow-up.
10-year CVD risk level was assessed by using WHO 10-year CVD risk score. Risk levels were categorised as low (
Associated factors influencing CVD risk.
The study included 341 hypertensive individuals, with a 99.1% response rate. Of the respondents, 58.9% were men. The overall prevalence of CVD risk within the coming 10 years was 134 (39.3%; 95% CI: 34.1% to 44.5%). Multivariable logistic regression analysis identified age, khat chewing, smoking and comorbid conditions as significant independent predictors of CVD risk. Specifically, individuals aged 60–69 years had an adjusted OR (AOR) of 3.97 (95% CI: 1.94 to 8.16) and those aged 70–74 years had an AOR of 2.99 (95% CI: 1.57 to 5.71). Khat chewers had an AOR of 2.58 (95% CI: 1.22 to 5.46), smokers an AOR of 3.44 (95% CI: 1.59 to 7.48) and individuals with comorbidities an AOR of 2.42 (95% CI: 1.47 to 3.99).
There is a significant increase in 10-year CVD risk among hypertensive patients in the study area. Age, khat chewing, smoking and comorbidities were independent predictors. Regular CVD risk screening for older patients, focused health education to reduce khat and tobacco use and integrated management of comorbidities are essential to lower future cardiovascular risk.
Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer mortality worldwide. Despite the organised CRC screening programme, the uptake rate of the population-based CRC screening was still low. Thus, we will conduct a randomised controlled trial in a community setting to evaluate the effectiveness of a theory-based chatbot in promoting CRC screening uptake.
A total of 500 eligible participants will be randomly assigned to a WhatsApp Messenger-initiated chatbot outreach group or a standard text reminder group at a ratio of 1:1. The intervention group will deliver Chinese culturally tailored education texts and videos developed based on the Health Belief Model and the Trans-Theoretical Model. The control group will deliver a standard text reminder of information about the Hong Kong organised CRC screening programme. In addition to the baseline assessment and postintervention assessment, all subjects will be followed up for 3 months and 6 months, respectively. The primary outcome will be the CRC screening uptake rate at the 3 month and 6 month follow-up. The secondary outcomes will be the intention to undergo CRC screening uptake, time interval to participate in and complete screening after recruitment, and reasons for not participating in screening at the 3 month and 6 month follow-up. Quantitative data will be analysed using Student’s t-test, Pearson’s 2 test or Fisher’s exact test. Qualitative data will be analysed by thematic analysis.
Ethical approval of this trial was granted by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (2022.614). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals.
The study was registered on clinicaltrials.gov (NCT06192862).