View clinical trials related to Adverse Event.
Filter by:In France, improving the practice of health professionals working in coordinated primary care teams (health centres called Maisons de Santé Pluriprofessionnelles - MSPs) could be facilitated by a learning system consisting of (i) a risk management support programme and (ii) the provision of a comprehensive online system combining training, reporting and support for the analysis and management of patient safety incidents (PSIs). EVIDENS-Prim is a multi-method, multi-centre, prospective study. It aims to describe the PSIs that occur in MSPs, using an international classification system, and to describe the ways in which professionals have adopted a global approach to PSIs management, from PSI reporting to feedback.
Observational assessment through patient interviews of relational, structural and organisational aspects related to the humanisation of health care. These data will be related to health outcomes such as pain, sleep quality, anxiety levels, adverse events (pressure injuries, falls, and mortality), satisfaction with the care received, and experience in communication processes with health professionals. Data will also be collected on work ergonomics variables (stress, burnout, working conditions, ratios) of nurses and health technicians, which will also be related to the health outcomes collected.
Developments in the healthcare sector in general, and in oncology in particular, mean that patients are increasingly autonomous. Outpatient treatment raises the issue of home monitoring. One of the solutions proposed by the 2014-2019 Cancer Plan is the development of telemedicine. Several programmes have been set up in the medical oncology department at Hôpital Mondor, to make patient care more secure and improve the management of undesirable effects of treatment for patients undergoing intravenous (I.V.) chemotherapy or oral anti-cancer treatments. The preliminary study on the use of the digital solution Onco'nect demonstrated the feasibility of using a dematerialised tool for real-time monitoring and management of chemotherapy-induced adverse events in cancer patients undergoing outpatient treatment. The tool was used to help AP-HP institution deal with the crisis linked to the COVID epidemic. Once it had been configured, Onco'nect was deployed to all institution's hospital groups to ensure that infected patients could remain at home, and that patients hospitalised with symptomatic COVID infection could return home. Hypothesis: The digital solution Onco'nect would improve patient compliance and could reduce the occurrence and improve the management of unexpected adverse events. Primary objective: In terms of clinical evaluation, the primary objective is to assess the effect of using the Onco'nect solution for ambulatory oncology follow-up on reducing the rate of occurrence at 6 months follow-up of unexpected and unwanted chemo-induced adverse events. The solution is already on the market and has been integrated (or is in the process of being integrated) into the care systems of the participating AP-HP establishments. The aim of the project is to evaluate its use in routine care and measure the occurrence and management of unexpected and unwanted chemo-induced adverse events in outpatients treated for cancer. This observational study of care pathway, using retrospective data, aims to include 480 patients in a 18 months period. Three periods of interest will be considered in this before-and-after study - Onco'nect pre-deployment (12 months): period covering the year prior to the actual implementation of the solution in each centre; patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to assess follow-up at 6 months. - Onco'nect deployment: this period corresponds to the implementation of the solution in the centre's care pathway. Deployment includes interoperability with other operating systems and setting up the collection interfaces for the user. - Post-deployment (12 months): period covering the year following the implementation of the solution within the centre (installation, interoperability and configuration validated); patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to be able to evaluate the 6-month follow-up.
The study objectives are as follows: - To determine the safety of trial 18F-2-fluoro-2-deoxy-D-glucose, produced by a new manufacturer, by surveillance for adverse events in patients having Positron Emission Tomography Computed Tomography scans in a comprehensive program for indications including, but not limited to, oncology, neurology, cardiac and infectious/inflammatory processes. - To determine the efficacy of 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography in differentiating benign from malignant solitary pulmonary nodules and calculate sensitivity, specificity, and accuracy using pathologic confirmation as the gold standard when available, or greater than 6 month follow up stability on Computed Tomography scan when not. The purpose of performing this clinical trial is to provide local access of 18F-2-fluoro-2-deoxy-D-glucose to the patients of Newfoundland and Labrador. This product has been offered to patients over the last three years by transporting from facilities outside of the province. There have been significant delays in access and in fact, times where 18F-2-fluoro-2-deoxy-D-glucose has not been available through this process. This has caused delays and limitations of treatments for patients who rely on Positron Emission Tomography Computed Tomography scans for diagnosis.