BMJ open
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Randomized Controlled Trial Multicenter Study
Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping.
Tinnitus is the perception of sound in the absence of a corresponding external acoustic stimulus. Bimodal neuromodulation is emerging as a promising treatment for this condition. The main objectives of this study are to investigate the relevance of interstimulus timing and the choices of acoustic and tongue stimuli for a proprietary bimodal (auditory and somatosensory) neuromodulation device, as well as to explore whether specific subtypes of patients are differentially responsive to this novel intervention for reducing the symptoms of chronic tinnitus. ⋯ This study protocol is approved by the Tallaght Hospital/St. James's Hospital Joint Research Ethics Committee in Dublin, Ireland, and by the Ethics Committee of the University Clinic Regensburg, Germany. Findings will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals and presentations at scientific and clinical conferences.
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Multicenter Study Comparative Study Pragmatic Clinical Trial
Comparison of regional with general anaesthesia on postoperative delirium (RAGA-delirium) in the older patients undergoing hip fracture surgery: study protocol for a multicentre randomised controlled trial.
Postoperative delirium (POD) is a common serious postoperative complication especially in older people and is associated with increased mortality, morbidity and healthcare costs. There is no clear consensus which anaesthesia is associated with less incidence of POD for older patients. We aim to assess whether regional anaesthesia results in lower incidence of POD comparing with general anaesthesia (GA) among older patients undergoing hip fracture surgery. ⋯ Ethical approved by the local institutional review board. Trial results will be presented at national and international academic conferences, and published in peer-reviewed journals.
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Randomized Controlled Trial Multicenter Study
Secondary analysis of frequency, circumstances and consequences of calculation errors of the HEART (history, ECG, age, risk factors and troponin) score at the emergency departments of nine hospitals in the Netherlands.
The HEART score can accurately stratify the risk of major adverse cardiac events (MACE) in patients with chest pain. We investigated the frequency, circumstances and potential consequences of errors in its calculation. ⋯ Our results show that the HEART score was incorrectly calculated in 15% of patients, leading to inappropriate risk categorisation in 5.8% which may have led to suboptimal clinical decision-making and management. Actions should be taken to improve the score's use in daily practice.
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Borderline resectable pancreatic cancer (BRPC) can involve the portal vein, superior mesenteric vein, superior mesenteric artery, coeliac axis or hepatic artery, and has a high probability of positive surgical margins and poor prognosis after resection. Neoadjuvant chemoradiation is expected to provide substantial local control and prolong survival in patients with BRPC. ⋯ This trial has been approved by the National Cancer Center Institutional Review Board. Written informed consent will be obtained from all participants. Serious adverse events will be reported to the safety desk of the trial, the Data and Safety Monitoring Board and trial sites. Trial results will be submitted for peer-reviewed publication.
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Multicenter Study Comparative Study Observational Study
Korean OBEsity Surgical Treatment Study (KOBESS): protocol of a prospective multicentre cohort study on obese patients undergoing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass.
Bariatric surgery effectively induces long-term weight loss in Western populations. However, its effectiveness in Asians remains to be confirmed objectively. The Korean Society for Metabolic and Bariatric Surgery proposes the first prospective cohort study on Koreans undergoing bariatric surgery. ⋯ Ethics approval was obtained from the institutional review board of each participating hospital. All findings arising from this cohort study will be published in open-access peer-reviewed journals and will be presented at national and international meetings. All KOBESS investigators will be able to propose research studies and potential publications based on KOBESS data and tissue samples.