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After resuscitation from out of hospital cardiac arrest (OHCA), mechanical ventilation (MV) and respiratory management are fundamental to support patients in the intensive care unit (ICU) and to minimise secondary brain injury. Best practices for MV and association with clinical outcomes in patients with OHCA remain unclear.
This protocol describes a pre-planned respiratory-focused series of sub-analyses within the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, an ongoing interventional study evaluating 6-month mortality after randomisation in patients admitted to ICUs following OHCA. The primary aim is to describe real-world ventilator settings and gas-exchange targets during the first 72 hours after ICU admission in patients receiving invasive mechanical ventilation after OHCA. Secondary aims include to estimate the incidence of respiratory complications during ICU stay (eg, ventilator-associated pneumonia, acute respiratory distress syndrome, barotrauma); and to explore the association between early ventilator settings/gas-exchange parameters and 6-month outcomes (mortality and neurological status). Exploratory aim is to characterise weaning and extubation practices, including timing and failure rates.
Eligible patients will include adult STEPCARE participants receiving invasive MV after return of spontaneous circulation with available respiratory data recorded within the STEPCARE database.
Data collected in the STEPCARE trial that will be analysed include patients’ prehospital characteristics; clinical examination at hospital admission and at ICU admission; ventilator settings and arterial blood gases recorded at predefined time points during ICU stay. In particular: MV setting (mode, tidal volume, positive end-expiratory pressure, fraction of inspired oxygen, tidal volume, mechanical power, plateau/driving pressures), gas-exchange values (arterial partial pressure of oxygen and carbon dioxide, pH, arterial saturation of oxygen), timing of measurements and the occurrence/timing of respiratory complications and weaning outcomes.
The STEPCARE study has been approved by the regional ethics committee at Lund University (Dnr 2022-02425-01, Approved IRB on 2022-06-18) and by all ethics boards in the participating countries. No additional ethical approval is required for this predefined secondary analysis, as no further data collection or interventions will be performed. Findings will be disseminated through publication in peer-reviewed journals and, where appropriate, conference abstracts and presentations. Patients and the public were not involved.
Acute febrile illness is a major cause of morbidity and healthcare seeking in sub-Saharan Africa, including Mozambique. However, few studies have explored the perceptions and practices related to clinical management of acute febrile illness. Our aim was to understand the perceptions, knowledge and practices of healthcare professionals and community members regarding the management of acute febrile illness.
A qualitative study was conducted using a thematic analysis approach. Eight focus group discussions (FGDs) and three in-depth interviews (IDIs) were conducted in two Mozambican provinces across four healthcare facilities. Purposive sampling was used to select participants, comprising both healthcare professionals and community members. Data were analysed thematically through manual coding, applying inductive and deductive approaches, in line with established qualitative analytical frameworks.
The study included a total of 60 participants, 28 healthcare professionals who participated in FGDs (25) and IDIs (3) and 32 community members who participated in FGDs. Major causes of fever, according to healthcare professionals, were upper and lower respiratory infections, malaria, diarrhoeal diseases and COVID-19. The diagnostic approach for febrile patients primarily included screening, malaria testing and other non-specific investigations depending on availability at health facilities. Antibiotics and antipyretics were the most commonly prescribed treatments. The healthcare professionals reported a decrease in prescribing antimalarials due to extensive training on malaria case management. In contrast, community members reported relying primarily on home-based and traditional practices to treat acute febrile illness before seeking care at health facilities. These practices are related to sociocultural habits, such as the use of traditional medicine and self-medication. The main barriers to seeking care at health facilities were the perception of poor quality of care, long waiting times, cultural beliefs and lack of medicines.
Proper management of non-malarial febrile illness remains a major challenge for both healthcare professionals and communities. Training, adherence to case management protocols and efforts to change behaviours to mitigate harmful sociocultural practices are urgently necessary to improve febrile illness management.
by Linda Furness, Janani Pinidiyapathirage, Matthew French, James Ware, Liam Weber, Brendan Carrigan
IntroductionIn rural generalist clinical settings, medical trainees routinely assess patients and discuss their findings with supervisors to plan ongoing care. These interactions termed ‘learning conversations’, serve as important opportunities for workplace-based learning and clinical decision making. However, preliminary evidence and stakeholder feedback indicate a lack of shared understanding regarding how these conversations should be structured, facilitated, and optimised. This study aims to observe current practices, identify supervisor and trainee learning needs, and co-design a model of learning conversations that enhances educational value and supports safe, effective patient care.
Methods and analysisThis study will use an exploratory sequential mixed methods design structured around the 3Cs of co-design (Co-define, Co-design, Co-refine). Phase 1 (co-define) will involve qualitative observation and audio-recording of learning conversations across two rural hospitals to characterise current practice and inform a protype model. In Phase 2 (co-design), supervisor and trainee focus groups will explore perceived needs, expectations, and feedback on the prototype model. A national online survey of rural supervisors and trainees will further inform model refinement. Phase 3 (co-refine) will incorporate national stakeholder input through a workshop, followed by feasibility testing of the refined model during a pilot simulation at a Rural Clinical School. Outcome data will focus on model usability, perceived relevance, applicability across contexts, and users’ experiences of employing the model during simulated learning conversations.
DiscussionThis study will produce a stakeholder-informed model that responds to the specific learning and clinical needs of rural generalist practice. By embedding co-design throughout the research process, the resulting model is expected to strengthen learning conversations, optimise trainee learning, and enhance the quality and safety of patient care. The findings have potential applicability across broader health professional training contexts and can support workforce development in rural healthcare settings.
The Mental health care: Adverse Sequelae of COVID-19 study aimed to (1) compare the consequences of the COVID-19 pandemic for mental health services and people with pre-existing mental health conditions (MHCs) in six low- and middle-income countries and (2) identify good practice to mitigate these impacts.
An observational study, using a mixed-methods convergent design triangulating data from (1) semistructured interviews or focus groups and/or a self-completed survey, (2) routine service utilisation data, (3) local grey literature and (4) expert consultation.
The study was conducted in Chile, Ethiopia, Georgia, Nigeria, South Africa and Sri Lanka.
121 key informants.
We found clear evidence in all sites that the pandemic exacerbated pre-existing disadvantages experienced by people with MHCs and led to a deterioration in the availability and quality of care, especially psychosocial care. Alongside increased vulnerability to COVID-19, people with MHCs faced additional barriers to accessing prevention and treatment interventions compared with the general population. To varying extents, sites showed accelerated implementation of digital technologies, but with evidence of worsening inequities in access. In sites where primary care-based mental healthcare was more developed or prioritised, systems seemed more resilient and adaptive.
Our findings have the following implications. First, these mental health service reductions are clear examples of ‘structural stigma’, namely policy level decisions in healthcare which place a low priority upon services for people with MHCs. Second, integration of mental healthcare into all general healthcare settings is key to ensuring accessibility and parity of physical and mental healthcare. Third, digital innovations should be designed to strengthen and not fragment health systems. We discuss these findings in terms of anticipating such challenges for future pandemics and preparing layers of resilience.
by Patricia Fiorino, Luigi Fernandes Rosa Cauduro, Danielle Silberspitz Konig, Leonardo Fernandes Rosa Cauduro, Caio de Araujo Santos, Juliana Alves Kavai, Isadora Durigan Duarte, Anna Laura Viacava Américo
Zebrafish (Danio rerio) are widely used as models in cardiovascular research due to their rapid development, optical transparency, and genetic similarity to humans. However, the lack of standardized experimental conditions, particularly regarding developmental stage and microenvironmental parameters, limits reproducibility across studies. This study aimed to characterize cardiovascular function in Zebrafish larvae and evaluate the impact of developmental stage and environmental factors. Wild-type AB embryos were maintained under standard conditions, and heart rate (HR), cardiac output (CO), and ejection fraction (EF) were measured at 24, 30, 48, 52, 56, 72, 78, and 80 hours post-fertilization (hpf). The effects of variations in temperature (27.0, 27.5, and 28.0 °C) and pH (7.0, 7.4, and 8.0) were also assessed. Results showed a progressive increase in HR from 24 to 72 hpf, stabilizing thereafter. CO exhibited two phases of elevation: an early rise between 24–48 hpf and a stronger increase between 48–56 hpf. EF remained generally stable, with a transient reduction at 48 hpf. Cardiovascular performance reached a physiologically stable state after 72 hpf, defining a reliable window for functional studies. Environmental conditions modulated these parameters: temperature variation induced approximately 20% difference in HR and reduced EF, while CO was minimally affected. In contrast, pH variations within the physiological range had no significant impact on HR, CO, or EF. These findings highlight developmental and environmental variables that may influence cardiovascular measurements in Zebrafish larvae and support the development of more consistent experimental approaches in cardiovascular and toxicological research.
To examine the effectiveness of Internet-delivered Cognitive Behaviour Therapy (ICBT) in improving psychosocial well-being and promoting weight-loss in adults ≥ 18 years with BMI ≥ 25 kg/m2.
Global obesity engenders significant physical and psychosocial health consequences. Second-wave ICBT focused on restructuring negative thoughts and behaviours has been explored as a potential intervention for elevated BMI and mental health concerns, but its effectiveness remains to be fully established, making further evaluation essential.
Eight databases were searched from inception to January 2025 for randomised controlled trials (RCTs), including participants ≥ 18 years with BMI ≥ 25 kg/m2 and second-wave ICBT evaluating BMI, weight, depression, eating behaviours, and self-esteem. This review followed PRISMA 2020. Study quality was assessed using the Cochrane Risk of Bias (ROB 2) and GRADE. Data were extracted using a modified Cochrane form. Random-effects meta-analysis calculated Standardised Mean Differences (SMD) with 95% confidence intervals, with subgroup analyses exploring heterogeneity.
Nine trials with 2278 participants were included. Significant improvements were seen in BMI, weight, and depressive symptoms while self-esteem effects were small and non-significant. Compared with passive controls, ICBT showed greater improvements in BMI and weight, whereas differences versus active control were smaller and inconsistent. Face-to-face CBT demonstrated superior outcomes for depression and self-esteem. Male-tailored interventions showed greater improvements. Shorter programmes yielded larger short-term weight loss, while longer programmes supported more sustained effects. Narrative synthesis indicated improvements in emotional and external eating, with increased mindful and restrictive eating behaviours.
ICBT improved weight, BMI, and depressive symptoms, with limited evidence for self-esteem. Male-tailored interventions and longer programmes may enhance sustainable outcomes.
Future ICBT programs should integrate strategies targeting sustainable weight loss and psychosocial well-being to support long-term outcomes.
Patients or members of the public were not involved, as this study synthesised previously published data.
PROSPERO registration number: CRD42024497961
by Hongzhen Yin, Tong Wang, Changshun Zhong, Yingya Cao, Xiaogan Jiang, Qiancheng Xu, Weihua Lu
Airway foreign-body aspiration in adults is uncommon but can be life-threatening.Flexible bronchoscopy is the standard first-line therapy,but critically ill patients may need extracorporeal life support.This study aims to characterize the diagnosis,management,and outcomes of adult airway foreign-body cases treated at a single center over nearly 12 years to inform a standardized clinical pathway.A single-center retrospective observational study of consecutive patients aged ≥14 years with confirmed airway foreign body who were treated at a tertiary hospital in China were conducted.Medical records of consecutive adolescent and adult patients diagnosed with airway foreign-body aspiration and admitted to the hospital from 01/01/ 2014–30/11/2025 were reviewed.Data included demographics,imaging,extraction method, respiratory support and so on.Descriptive statistics were reported as medians with interquartile ranges or counts and percentages.A total of 41 patients were included,with a median age of 59.5 years(interquartile ranges 51–72) and 65.85% male.Flexible bronchoscopy was attempted as the primary intervention in 38 patients(92.68%) and succeeded in 81.58%(31/38) to remove airway foreign body.Most patients(78.05%) required only nasal cannula oxygen,while nine patients(21.95%) needed advanced support including mechanical ventilation (14.63%),high-flow oxygen(4.88%),and extracorporeal life support (2.44%).At discharge,most survivors had a good neurological outcome,with 36 patients(87.80%) having a Cerebral Performance Categories score of 1.The 28-day survival rate was 92.68%.These findings show that flexible bronchoscopy is an effective first-line therapy,and rigid bronchoscopy or surgery is useful when flexible bronchoscopy fails.In unstable cases,timely extracorporeal life support can bridge to definitive removal.These results support a tiered,multidisciplinary approach incorporating early chest computed tomography,flexible bronchoscopy,and escalation to advanced airway or extracorporeal support.
Approximately one-third of people with epilepsy (PWE) experience resistance to treatment, including pharmacological therapies, epilepsy surgery, vagus nerve stimulation (VNS) and dietary interventions such as the ketogenic diet (KD). Emerging evidence suggests that the gut microbiota may influence seizure susceptibility and treatment response through the microbiota-gut-brain axis, potentially contributing to treatment resistance. The MiCrobiota-gut-brain Axis in Resistant Epilepsy project investigates how gut microbial features and associated host epigenetic signatures affect clinical outcomes in PWE undergoing diverse treatment strategies.
This is a multicentre, prospective, longitudinal study involving four clinical centres in Italy and one self-financing partner. Participants aged 3–50 years will be enrolled and stratified into four intervention cohorts: newly diagnosed drug-naïve epilepsy scheduled to start anti-seizure medications, focal drug-resistant epilepsy (DRE) undergoing epilepsy surgery, DRE receiving VNS, and DRE initiating KD. Clinical assessments (including body mass index calculation, self-reported monthly seizure count, dietary evaluation, quality of life scale and gastrointestinal symptoms scale), electroencephalography, MRI and biological sample collection (stool and blood) will be obtained at baseline and longitudinally at two or three timepoints over a 12-month observation period. Gut microbiota changes over time will be assessed via metagenomics (using 16S ribosomal RNA sequencing) and metaproteomics; the associated host DNA methylation profiles will be obtained from blood using Illumina EPIC arrays. Primary endpoints include identification of microbial or host methylation changes predictive of therapeutic response (ie, reduction from baseline in monthly seizure count) to the intervention. Data will be analysed using multivariate models and mixed-effect regression. Further, omics data and corresponding metadata will be integrated using multi-omics approaches to identify molecular signatures biomarkers predictive of treatment response and prognosis in PWE.
The study received ethical approval from the Research Ethic Board (Comitato Etico Territoriale Lombardia 3, ID 4896 – parere numero 4896_17.07.2024_N_bis). All participants or their legal guardians will provide written informed consent. Results will be disseminated through peer-reviewed publications, conference presentations or lay summaries targeting patient organisations.
ClinicalTrials.gov Identifier NCT07010445, registered on 2 May 2025.
Patient safety is crucial in healthcare, especially in home-based settings where unregulated environments and limited supervision pose unique challenges. With the expansion of home healthcare due to an ageing population and healthcare workforce shortages, there is a pressing need for tools to assess patient safety culture in this context. Current instruments, developed for hospitals, do not adequately address the specific dynamics of home healthcare, such as patient autonomy and caregiver involvement. This protocol outlines the development and validation of the Patient Safety Culture in Home Health Care Centers Instrument (PSCHCI), using a sequential exploratory mixed-methods approach.
This sequential exploratory mixed-methods protocol consists of three phases. Phase 1 fieldwork (semi-structured interviews with 15 participants, 3 participant observations and field notes) has been completed. Qualitative data are currently being analysed using conventional content analysis. The scoping review component of Phase 1 is planned but has not yet been conducted. Phase 2 (instrument development) is planned to include item generation from qualitative results followed by expert panel review. Phase 3 (psychometric evaluation), scheduled for late 2026, will employ a cross-sectional study to assess face, content and construct validity; reliability; interpretability; and feasibility. This phase features pilot testing (n=30–50), face and content validity assessment (n=10 each), test-retest reliability (n=15) and exploratory and confirmatory factor analyses (n=300–400).
Ethical approval was obtained from the Ethics Committee of Iran University of Medical Sciences. All participants will provide written informed consent. Confidentiality, voluntary participation and withdrawal rights are guaranteed. Findings will be published in peer-reviewed journals, presented at conferences and shared with participating home healthcare centres, policymakers and stakeholders.
To estimate the prevalence and frequency of workplace incivility and bullying across multiple healthcare roles; compare experiences among occupational groups; examine associations with psychological symptoms (stress, anxiety and depression); assess interrelations among mistreatment dimensions (experienced workplace incivility (EWI), witnessed workplace incivility (WWI), instigated workplace incivility (IWI and experienced workplace bullying (EWB)); and evaluate associations with demographic and contextual variables.
Cross-sectional study.
Three teaching hospitals in Arak, Iran, between March and December 2023.
A stratified random sample of 550 healthcare workers was invited; 392 responded (response rate 71.3%) and 359 with complete data were included, comprising nurses, interns, residents, general practitioners and administrative staff.
Workplace incivility (Workplace Incivility Scale), workplace bullying (Negative Acts Questionnaire-Revised) and psychological symptoms (Depression, Anxiety and Stress Scale-21 Items).
The sample (N=359) was 64% female with a mean age of 32 years. Significant differences were observed across occupational groups for WWI, IWI and EWB (all p
Workplace incivility and bullying are widespread across healthcare roles, with broadly comparable exposure across clinical staff. Direct experiences of mistreatment showed the most consistent associations with psychological distress, and mistreatment dimensions appeared to operate within interconnected patterns. Addressing these issues requires system-level interventions targeting structural and cultural drivers to promote psychologically safe clinical environments.
To identify psychosocial and structural barriers to prompt malaria care-seeking in Malawi by applying the Three Delays Model (delay 1: deciding to seek care; delay 2: reaching a facility; delay 3: receiving quality care).
cross-sectional study.
Nationally representative data collected from Malawi communities between 25 May 2021 and 1 July 2021.
913 female caregivers who reported a child with fever in the past 2 weeks.
Prompt care-seeking for fever (same or next day) from a qualified health provider.
Prompt care-seeking was primarily associated with delay 1 (adjusted OR (aOR) 0.58, 95% CI 0.43 to 0.78) and psychosocial (aOR 0.59; 95% CI 0.44 to 0.79) factors. Significant factors included incorrect knowledge of malaria symptoms, cause and diagnosis (aOR 0.71: 95% CI 0.53 to 0.97), negative attitudes towards care-seeking (aOR 0.58; 95% CI 0.41 to 0.82), incorrect knowledge of when and where to seek care (aOR 0.19: 95% CI 0.07 to 0.50) and far distance from a health facility (aOR 0.67, 95% CI 0.49 to 0.93).
Despite the availability of free malaria services, significant bottlenecks remain in the initial decision-making phase. To reduce malaria mortality, national programmes should prioritise social and behaviour change interventions that move beyond general awareness to target specific care-seeking attitudes and intra-household decision-making dynamics.
Post-COVID-19 condition (PCC) has emerged as a major public health concern. We aimed to estimate the 1-year incidence of PCC in adults with confirmed SARS-CoV-2 infection in Lombardy, Italy, comparing community-managed and hospitalised patients and to assess the prognostic value of the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) score to support estimation of long-term PCC prevalence.
Retrospective-prospective observational cohort study enrolling patients infected between 1 March 2020 and 31 December 2022. The study visit was conducted between 16 January and 23 December 2024.
Multicentre study involving seven public hospitals and general practitioners across Lombardy.
Randomly sampled adults aged 18–70 years with confirmed SARS-CoV-2 infection. Hospitalised patients (HP) were admitted for COVID-19; general practitioner patients (GPP) were managed in the community. The total sample comprised: 1162 (546 HP, 616 GPP).
This is an observational study with no active intervention.
Primary outcome: 1-year incidence of PCC retrospectively assessed at the study visit.
Secondary outcomes: symptom profiles, long-term PCC prevalence at the study visit and predictive value of the NIH RECOVER score.
Median age was 57.1 years in HP and 42.9 years in GPP; 66.1% of HP and 47.7% of GPP were male. PCC developed in 280 patients (223 HP, 57 GPP). The 1-year cumulative incidence was 39.9% in HP (95% CI 35.9% to 44.1%) and 9.1% in GPP (95% CI 7.1% to 11.7%). The NIH RECOVER score was associated with PCC at 1 year (OR 1.18, 95% CI 1.14 to 1.21). Model-based long-term PCC prevalence was 31.8% in HP and 6.3% in GPP.
PCC remained frequent and heterogeneous, particularly among previously HP. In this cohort, the NIH RECOVER score showed prognostic value for estimating longer-term PCC burden. These findings underscore the need for structured long-term follow-up across both hospital and primary care settings.
Treatment for women with endometriosis is only partially or temporarily effective. Moreover, medical hormonal treatment is associated with debilitating side effects and interferes with fertility, while surgery has a relatively high risk of complications. Meanwhile, women with endometriosis show increasing interest in implementing lifestyle interventions to alleviate symptoms and improve health-related quality of life (HRQoL). Integrating these lifestyle interventions can provide a holistic approach to the treatment of this debilitating disease. However, scientific evidence supporting the effectiveness of these interventions is limited. This study is designed to investigate the effectiveness of two lifestyle interventions and the combination of both: an anti-inflammatory diet intervention (AIDI) could improve immune cell function and reduce inflammation, resulting in improved HRQoL and alleviating pain. In addition, the integration of cognitive behavioural therapy (CBT) aims to provide insight into pain mechanisms and coping with pain, and to assist in sustaining dietary adjustments.
The Pain in Endometriosis And the Relation to Lifestyle (PEARL) study is a five-arm randomised controlled trial with a pre-post factorial design with two factors: an AIDI and CBT. The study population will consist of 250 premenopausal women, of whom 200 are diagnosed with endometriosis and experience pain symptoms and 50 are healthy controls (HC). Women with endometriosis will be recruited from one academic tertiary and five secondary hospitals in the Netherlands. They will be randomised (1:1:1:1) among four intervention groups: standard care (SC) (SC group), SC and an AIDI (SC + AIDI group), SC and CBT (SC + CBT group), and SC, AIDI and CBT (SC + AIDI + CBT group). Women with endometriosis will visit the hospital twice during the intervention period, at the start (T0) and end (T2) of the 13-week intervention period. HC will not undergo any of the interventions and will have one hospital visit (T0). Participants will complete questionnaires regarding pain symptoms, HRQoL, physical activity level, sleep, diet quality, pain cognitions, and stress at T0 and T2. Furthermore, they are instructed to collect menstrual effluent, a vaginal swab and a faecal sample. During the study visits, peripheral blood will be drawn and scalp hair samples will be taken. The primary outcome is average pain, measured using a numerical rating scale. Secondary outcomes focus on HRQoL, inflammation, immune system characteristics, vaginal- and gut microbiome, and hair cortisol levels. These are considered to reflect potentially underlying mechanisms of the effect of both interventions on the primary outcome. Biological samples and questionnaires of women with endometriosis and HC will be compared to establish the differences in secondary outcomes.
This study protocol has been approved (approval number: NL86247.091.24) by the METC Oost-Nederland from Radboud University Medical Centre on July 11, 2024. Prior to participation, participants are required to provide informed consent. The results will be widely disseminated through scientific peer-reviewed journals, and presentation to a broad audience in scientific meetings, congresses, patient meetings, as well as in policy-relevant forums.
Congenital malformations (CMs) are the leading cause of infant mortality. Still, the aetiology remains unknown in 70% of cases. The most accepted hypothesis is that hereditary and environmental elements concur in altering embryo-fetal development. Recently, the role of the environment has been emphasised.
Women are exposed to several xenobiotics during pregnancy. This review aims to study the available literature on the exposure of pregnant women to pesticides through drinking water to see if there is any evidence of correlation to the onset of any kind of congenital anomalies.
We will conduct a systematic literature review in The Cochrane Library, Embase and PubMed for studies published between 1 January 2005 and 31 January 2026. Articles will be included if they examine pregnant women as the study population, exposure to pesticide active ingredients and metabolites present in drinking water, and any type of CM in their children as the main outcome. The screening of title, abstract and full text as well as the data extraction will be conducted independently through two investigators. A third investigator will resolve any eventual conflicts. Each included study will be evaluated according to the NIH’s quality assessment tools. Grading of Recommendations Assessment, Development and Evaluation approach will be used for summarising and assessing certainty in the bodies of evidence produced by the review. This study is registered with PROSPERO, CRD420251063011.
The completed work will be published in a scientific journal for dissemination. Due to the nature of the study, an ethical approval is not necessary since no patient data or other information will be directly collected.
Frostbite is a common reason for emergency department (ED) presentations in Canada. Iloprost, a prostacyclin analogue, has been investigated to reduce the risk of amputation with its use expanding. Two Canadian cities implemented iloprost over different times leading to a practice variation that allowed for treatment comparison. Our objective is to evaluate the effectiveness of iloprost compared with non-iloprost treatment. Secondary objectives include assessing the impact of iloprost dosage and homelessness.
A retrospective cohort study was conducted on adult severe frostbite cases presenting to EDs in Calgary and Edmonton between November 2021 and April 2024. Data were abstracted from clinical databases and analysed for demographic and injury characteristics, treatment and amputation outcomes.
Of 1812 total ED encounters for frostbite, 257 patients with grades 2–4 extremity frostbite were included for analysis. Logistic regression found that overall patients receiving iloprost were associated with reduced likelihood of any amputation (OR=0.49, 95% CI 0.25 to 0.96) and fewer digit amputations (p
Iloprost infusion was associated with a reduction in amputation rates in grade 3 and 4 frostbite with the greatest association seen in grade 3 cases. Greater iloprost dosage was associated with improved digit salvage. Homelessness was associated with delayed ED presentation.
Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), is the hepatic manifestation of the metabolic syndrome. When it co-occurs with type 2 diabetes (T2DM), it presents a significant therapeutic challenge due to a higher risk of fibrosis progression and adverse outcomes. While new treatments for MASH are emerging, their efficacy in the T2DM subpopulation remains an unmet need. Chiglitazar is a novel peroxisome proliferator-activated receptor pan-agonist that regulates key pathways in lipid metabolism, glucose homeostasis and inflammation. This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.
This is a prospective, multicentre, randomised, double-blind, placebo-controlled study. This trial will enrol 300 adult patients aged 18–75 years with biopsy-confirmed MASH and fibrosis stage F1 or higher. Participants will be randomised (1:1) to receive either chiglitazar 48 mg daily or a matching placebo. All participants will also receive background therapy consisting of vitamin E (100 mg three times a day) and polyene phosphatidyl choline (456 mg three times a day). The treatment duration is 78 weeks. The primary efficacy endpoint is resolution of steatohepatitis with no worsening of liver fibrosis. Key secondary endpoints include improvement in liver fibrosis by at least one stage and changes in metabolic and liver safety biomarkers.
Ethical approval has been obtained from the Shanghai Punan Hospital of Pudong New District Ethics Committee (Punan Branch of Renji Hospital Ethics Committee, Shanghai Jiaotong University School of Medicine). KY2025-066. The findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.
Chronic musculoskeletal pain often extends beyond pathology alone. Augmented central pain processing is linked to pain severity, persistence and treatment outcomes. A practical clinical tool is needed to identify individuals likely to have persistent or worsening pain, likely due to augmented central pain mechanisms. Quantitative Sensory Testing (QST) offers mechanistic insight, while the Central Aspects of Pain (CAP) Questionnaire captures symptom profiles that potentially reflect central mechanisms. Combining a brief clinical QST protocol with CAP may support early risk stratification and guide personalised pain management.
This prospective observational study will recruit 250 individuals with inflammatory arthritis, osteoarthritis, chronic low back pain or fibromyalgia from existing cohorts, primary or secondary care. Participants will complete validated patient-reported outcomes at baseline, 6 and 12 weeks, with no additional intervention. The risk stratification tool completed at baseline will include clinical QST (Pressure Pain Threshold, Temporal Summation of Pain, Conditioned Pain Modulation), tender point count and the CAP questionnaire. Baseline laboratory versions of the clinical QST, plus Heat Pain Threshold, Offset Analgesia and the Central Sensitisation Inventory short form-9 questionnaire, will provide pain profiling to evaluate the predictive validity and psychometric properties of the tool. Data collection will include demographics, medical history, cognitive and neurological assessments and sleep quality via actigraphy (Actigraph wGT3X-BT). Interviews with patients and healthcare professionals will inform refinement, feasibility and acceptability of the tool.
Ethical approval was obtained from the Yorkshire & The Humber—South Yorkshire Research Ethics Committee (reference number: 24/YH/1062). Findings will be disseminated through peer-reviewed publications, conference presentations and patient-facing summaries and podcasts. The study aims to develop a clinically feasible tool to identify individuals at risk of persistent or worsening pain due to augmented central pain processing, enabling targeted treatment strategies.
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