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Filter by:The objective of this study is to collect the evolution of blood glucose levels in type 2 diabetes (T2D) patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.
Rationale: The pathophysiological changes in respiratory muscle morphology and functioning in patients with end-stage pulmonary disease are not very well known. Furthermore, in COPD, long-term high-intensity NIV is applied without knowing the exact consequences on the lungs and respiratory muscles. Objective: The aims of the study are to get insight in: A. changes respiratory muscles in end-stage respiratory disease, comparing COPD with restrictive lung disease (RLD) due to pulmonary fibrosis B. the effects of long-term HI-NIV in severe COPD patients on the respiratory muscles and the lungs; by comparing COPD patients that had been treated with long-term NIV to COPD patients that were not treated with long-term NIV. Study design: In order to investigate this, the investigators will include in a small pilot cohort study patients being lung transplanted. In these patients there is lung tissue available and respiratory muscle biopsies will be performed during lung-transplant surgery. Study population: Patients that are listed for lung transplantation for an underlying diagnosis of COPD or RLD will be asked to participate. Three groups will be included: patients with a RLD due to pulmonary fibrosis, COPD patients that had been treated with long-term NIV prior to being lung transplanted and COPD patients that were not treated with long-term NIV. Patients will be included definitely once being lung transplanted. Main study parameters/endpoints: The study is an exploratory pilot study. Both contractile strength and the structure of single diaphragm and intercostal muscle fibres as well as lung injury; i.e. alveolar structure and damage and inflammation in the alveoli, will be investigated.
This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis (NASH).
Rationale: The World Health Assembly resolution 68.15 identified surgical and anesthesia care as core components of universal health coverage. However, about 5 billion people worldwide lack access to essential surgical and anesthesia services. Of the 313 million procedures undertaken each year only 6% occur in the poorest countries with an estimated 30% of all deaths globally associated with common surgical conditions. Patient safety in low-resource settings is hindered by severe workforce shortages, lack of essential resources, hierarchical culture and few opportunities for professional development. Non-technical skills (NTS), such as communication, team working, and task coordination, are vital to patient safety. Up to 70-80% of untoward events in health care are associated with errors in NTS8. The Anaesthetists' Non-Technical Skills framework (ANTS) describes behaviour markers for NTS in anesthesia. This framework has been found applicable in low-resource settings. Simulation-based education is widespread for NTS training in well-resourced countries. Traditionally, high costs have prohibited this modality in low-resource settings. Foundational work in Rwanda and at Dalhousie University has demonstrated that effective training in ANTS can be achieved through simple low-cost simulation. The Vital Anaesthesia Simulation Training (VAST) Course is a three-day simulation-based program designed de-novo to focus on core clinical practices and NTS that promote safe perioperative care in low-resource settings. The course uses low-cost materials in an immersive simulated environment to replicate common cases managed in district hospitals in low-resource settings. Realism is created with simple mannequins, iPads with the SimMon App functioning as monitoring, basic props (e.g., airway equipment, syringes, drapes), photographs of pathology, and briefing cards for scenario role-play. Purpose: To assess the impact of the VAST Course on ANTS and explore factors that influence long-term retention of ANTS amongst anesthesia providers in a low-resource setting.
Major cardiovascular surgery is associated with postoperative cognitive decline (POCD), with a deterioration in memory, attention and speed of information processing. A multifactorial pathophysiology is presumed but this study focuses on the role of (neuro)inflammation in the development of POCD after coronary artery bypass grafting (CABG) surgery.
Background: Low physical activity and poor eating habits (incl. high fat and carbohydrates but low fiber intake) are the main reason of obesity epidemic in western societies. The most common clinical complication of this condition is non-alcoholic fatty liver disease (NAFLD), that can lead to liver cirrhosis and its complications. Recent studies show that gut dysbiosis may play a crucial role in the pathogenesis of NAFLD. On the other hand plant fiber shows beneficial properties in remodeling of the gut microbiome. Aim: The project aims to create low-calorie bars / snacks with an increased fiber content (12 g/bar), replacing the second breakfast and/or afternoon tea. The main scientific aim is to examine the influence of the extra supply of fiber on i. gut microbiota composition and metabolism and ii. liver function in patients with NAFLD. Methods: Randomized placebo-controlled double blind study. A group of patients diagnosed with NAFLD, divided into 2 groups: study (12% fiber bar) and placebo (maltodextrin bar). Two study phases: preliminary study (5 weeks, 20 patients) and main study (24 weeks, 120 patients). Both clinical and laboratory (stool and serum) aspects will be analyzed, incl. anthropometric measurements, nutrition tests (food frequency questionnaire), health-related quality of life, liver ultrasound and elastography, serum and stool biochemistry and microbiome analysis.
The induction dose of propofol is generally determined based on patients' characteristics, underlying disease, general condition, and also by clinician's experiences. However, It is difficult to anticipate and objectively calculate an adequate dose of propofol for every patient considering the variability of an individual's response to propofol. If there is a specific pattern in EEG prior to induction of anesthesia that can provide information about the patient's susceptibility to propofol, every induction may be performed far more smoothly with a precisely optimized dose of propofol for each patient. The study is to find a relationship between the pre-induction EEG pattern of adult patients and their sensitivity to propofol.
Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study
Previously, many studies have been conducted on mesenchymal stem cells derived from bone marrow or subcutaneous fat, but interest in cord blood-derived mesenchymal stem cell treatments has been increasing recently. In the case of cord blood as a source, the isolation of mesenchymal stem cells is easier than bone marrow or fat tissue, and cord blood-derived mesenchymal stem cells have an advantage as a treatment because they have faster population doubling time. To date, no clinical research on the treatment of patients using cord blood-derived mesenchymal stem cells has been reported in the literature, but there have already been registered at clinicaltrials.gov and currently being conducted overseas. In this study, we will study the safety and effectiveness of RDEB patient treatment using cord blood-derived mesenchymal stem cells with these advantages.