Conectar
Nipah virus (NiV) is a bat-transmitted paramyxovirus causing recurrent, high-mortality outbreaks in South and South-East Asia. As a WHO priority pathogen, efforts are underway to develop therapies like monoclonal antibodies and small-molecule antivirals, which require evaluation in clinical trials. However, trial design is challenging due to limited understanding of NiV’s clinical characteristics. Given the rarity of NiV infections, strategies targeting improved outcomes for the broader acute encephalitis syndrome (AES) patient population, including those with NiV, are essential for advancing therapeutic research. To address these gaps, we designed the Bangladesh AES cohort study to characterise the patient population, clinical features, treatment practices, common aetiologies and outcomes in patients presenting with AES, including NiV infection, as a clinical characterisation study to inform the design of clinical trials for NiV and AES more broadly.
This prospective cohort study will be conducted in Bangladesh, a NiV endemic country with annual outbreaks. In collaboration with the ongoing NiV surveillance programme in Bangladesh, we aim to enrol up to 2000 patients of all ages presenting with AES at three tertiary care hospitals within the Nipah belt. Patients who provide informed consent to participate will be monitored throughout their hospital stay until 90 days post enrolment. Data will be systematically collected through interviews and medical record reviews at several time points: on the day of enrolment, day 3, day 7, the day of critical care admission (if applicable), discharge day and 90 days post enrollment. Additionally, a portion of the cerebrospinal fluid collected under the concurrent NiV surveillance protocol will be tested for an array of viral and bacterial pathogens responsible for encephalitis at the International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b) laboratory.
The study received ethical approval from the Oxford Tropical Research Ethics Committee, University of Oxford, UK (OxTREC Ref: 576–23) and the institutional review board of icddr,b, Bangladesh (icddr,b protocol number: 24016). By characterising the AES patient population, this study will generate essential evidence on key clinical parameters, which will be pivotal in optimising the design of clinical trials for potential interventions aimed at improving outcomes in patients with AES, including those with NiV disease. Findings will be shared with participating hospitals, patients and relevant government stakeholders. Results will also be disseminated through conference presentations and peer-reviewed publications.
Not applicable (this is an observational study).
Elevated lipid profiles increase the risk of atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality worldwide. Despite the availability of lipid-lowering therapy (LLT), adherence to therapy and achievement of Low-Density Lipoprotein Cholesterol (LDL-C) target levels remain suboptimal. Coronary artery disease (CAD) presents substantial public health challenges, with LDL-C goal attainment rates reported to be between 30.0% and 54.0%. The EDHIPO MARCA (Evaluación De adherencia a la terapia HIPOlipemiante en pacientes de Muy Alto Riesgo CArdiovascular) study aims to evaluate LDL-C target achievement among Colombian patients with CAD.
This is a retrospective and multicentre study aiming to evaluate LDL-C target achievement within 12 months of coronary angiography across multiple Colombian institutions. Data will be retrospectively extracted from medical records corresponding to the years 2011, 2012, 2016, 2017, 2021 and 2022, which were selected to correspond with the European Society of Cardiology/European Atherosclerosis Society guideline updates. Inclusion criteria included patients ≥18 years old with confirmed CAD and LDL-C reports recorded during outpatient follow-up. The study will evaluate a minimum sample size of 5000 patients, with data collected through medical records and managed using the REDCap platform. Statistical analyses will be conducted to assess LDL-C target achievement, associated factors and temporal trends using mixed-effects models. Uncertainty will also be explored through sensitivity analysis. The EDHIPO MARCA study will provide key insights into LDL-C target achievement in Colombia, contributing to both regional and global CAD management. Its findings will be used to help shape public health policies and serve as a foundation for future prospective research and interventions aimed at mitigating the burden of cardiovascular disease.
This study was approved by the Comité de Ética en Investigación Biomédica of Fundación Valle del Lili, the coordinating institution and creator of the study protocol. Each participating centre will obtain approval from its local ethics committee prior to data collection. Data will be collected in a de-identified manner, ensuring confidentiality. In accordance with Colombian Resolution 8430, this study is classified as 'no-risk', and informed consent was not required. The findings will be disseminated through scientific events and published in international peer-reviewed journals to contribute to cardiovascular disease management and public health policies.
The global burden of chronic immune-mediated inflammatory diseases (IMIDs) is increasing, and rising prevalence rates significantly affect socioeconomic factors and quality of life. Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), along with ankylosing spondylitis (AS), are prominent chronic IMIDs that share overlapping pathophysiological mechanisms. Recent research has highlighted the importance of the gut microbiota in the pathogenesis of these diseases, suggesting that shared microbial dysbiosis may contribute to their development. Comprehensive research focusing on the gut and oral microbial characteristics and environmental factors is essential to elucidate the fundamental pathophysiology and develop personalised management strategies for IBD and AS. In-depth analyses and insights based on multiomics approaches are required to achieve these objectives.
This protocol describes a nationwide prospective observational study of CD, UC and AS in a Korean population. Over 5 years, we aim to recruit at least 900 patients with IBD and 200 first-degree relatives (FDRs), 500 patients with AS and 200 of their FDRs, and 2244 healthy controls. We will systematically collect clinical data and biological samples, including saliva, stool, blood and tissue biopsies, for integrative multiomics analyses focusing primarily on the microbiome. Highly advanced full-length 16S ribosomal RNA gene sequencing and shotgun metagenomics will be used to characterise the microbial composition of saliva and stool samples. Quantitative microbiome profiling will be used to address the pathological, physiological and ecological differences between microbial groups that may be masked by their relative abundance. Metabolomic analyses will be conducted on saliva, stool and plasma samples to assess functional metabolic profiles. Culturomics will be used to isolate, identify and characterise the diversity of microbial species, including rare or previously unrecognised species, to provide a comprehensive understanding of the microbiota associated with these diseases.
Ethical approval was obtained from the Ethics Committee of Kyung Hee University Hospital, Hanyang University Hospital, Kangbuk Samsung Hospital, Yeungnam University Hospital, Kyungpook National University Hospital, Chonnam National University Hospital, Wonkwang University Hospital, Catholic University Daejeon St. Mary’s Hospital, Soon Chun Hyang University Hospital Cheonan, Chung-Ang University Hospital, Inje University Haeundae Paik Hospital, Dankook University Hospital, Hanyang University Guri Hospital, Kyung Hee University Hospital at Gangdong, Chung-Ang University Gwangmyeong Hospital and Keimyung University Dongsan Hospital. Our research team will provide detailed information about the study, including an information sheet explaining its aims and procedures, prior to enrolment. Prospective participants will be informed that they have the right to withdraw from the study at any time, without penalty. Participants will be assured of the anonymity and confidentiality of any data they provide throughout the study, using participant numbers and the storage of sensitive data in locked cabinets. Participants will be enrolled in the study only after providing written informed consent to the research staff. The results of this study will be disseminated to healthcare and academic professionals through publications in peer-reviewed journals and presentations at international conferences.
This prospective observational study is registered at ClinicalTrials.gov ((ID: NCT06124833, data first posted: 9 November 2023); (ID:
Impaired cerebral autoregulation is associated with postoperative ischaemic brain injury and often occurs in patients with carotid artery stenosis. Adequate cerebral perfusion should therefore be maintained during carotid endarterectomies. Whether guiding intraoperative blood pressure to the Cerebral Oximetry Index (a measure of cerebral perfusion adequacy) reduces postoperative cerebral ischaemia remains unclear.
We plan a dual-centre randomised blinded trial. A total of 560 patients having elective carotid endarterectomy will be randomly assigned to guided versus routine haemodynamic management. In patients randomised to guided management, mean arterial pressure will be titrated to maintain a normal cerebral oximetry index. In the routine care group, mean arterial pressure will be targeted to within 20% of individual preoperative baseline values. The primary outcome will be the incidence of new ischaemic brain injury within 3 days after surgery assessed by brain imaging, with or without clinical symptoms. Secondary outcomes include the incidence of postoperative delirium, cognitive function and pain severity.
The study protocol (V.1.2, 1 January 2025) has been approved by the Medical Ethics Committee of Beijing Tiantan Hospital, Capital Medicine University (KY2024-049-03) and Xuanwu Hospital, Capital Medical University (LYS2025-023-001). The findings of the study will be disseminated in a peer-reviewed journal and at a scientific conference.
FreshRSS 