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Filter by:Clinical Data Validation of a Novel Continuous Vital Sign Monitoring System in Cancer Patients Background The Cortrium C3 device is a novel, inexpensive, chest-worn unit designed for measuring vital sign parameters. The unit is capable of logging and wireless transmitting data describing pulse, respiratory rate, body surface temperature, ambient temperature and accelerometer data (1,2). The C3 device is developed as a diagnostic tool in the medical practice to meet the demand for a modern reliable and open medical grad vital sign monitoring system. The device is based on state-of-the-art technologies and is produced using high quality off-the-shelf components. Although, new technologies may be of high value to the health care system, studies show that the quality of technologies vary and more empiric data is needed to either support or reject the advantages of using intelligent health technologies at home (3-5). Besides measuring the actual quality of C3, it is therefore also important to evaluate how patients experience quality in relation to C3 in addition to an evaluation of perspectives from the health professionals. Objective The objective of the study is to validate measurements of pulse, frequency of respiration, and temperature obtained with the C3 device by comparison with routinely used hospital equipment. Further, the objective is to gain knowledge about how patients experience to be monitored with C3 and how hospital staff experience working with C3. Design and participants The study is carried out on cancer patients at the Department of Oncology, Naestved Hospital, Region Zealand, Denmark (DONZ). Collaborating partners are Cortrium, University College Zealand and Sundhedsinnovation Zealand. The study consists of a quantitative and a qualitative part. The quantitative study is a cross-sectional study of paired measures of vital sign parameters (pulse, respiratory rate and temperature) measured by the C3 device and standard hospital equipment used at DONZ. The qualitative study is planned as observational studies and semi-structured interviews with patients, who have been monitored with C3 and health professionals who have been involved in treatment or care of monitored patients. Recruitment of participants will take place amongst newly hospitalized patients at DONZ. It is planned to include approximately 40 patients in February and March 2016. Side effects, risks and inconveniences No major side effects are related to wearing and being monitored by the C3 device. The device has been tested on healthy volunteers and reports of inconveniences are mostly related to the adhesive ECG-electrodes that can irritate the skin. However, a wide array of electrodes are commercially available to fit the individual needs. Some might find wearing the device stigmatizing and/or inconvenient. In addition, the C3 device is marked CE class I. Hence, requirements for prevention of adverse effects are met. As an example, this includes two fuses between the battery and the electrodes, minimizing the risk of current for the battery entering the body even in the event of device failure. The device has not yet been approved for commercialization. Ethics and anonymization All data collected in the study is done according to the guidelines of Good Clinical Practice (GCP) for medical device studies (6). All data is anonymized, and is protected according to national law: "Lov om behandling af personoplysninger". The project has been reported to "Datatilsynet" [the Data Protection Agency]. Test subjects are secured access to further information about the study through their assigned nurse or email and telephone. Approvals The study has been approved by the Danish Ethical Comity: SJ-460, and The Danish Medicines Agency: journal number 2015120113.
Malignant hyperthermia (MH) is a pharmacogenetic disease that manifests itself as a hypermetabolic response of skeletal musculature, in genetically susceptible patients, with the inhalation of volatile halogenated anesthetics, depolarizing neuromuscular relaxants such and, rarely, physical stressors such as intense exercise and heat stroke. HM diagnosis is based on the performance of two tests: - In vitro muscle contraction test (IVCT): it is the gold standard of the diagnosis of HM in Europe. - Pharmacogenetic study: about 50 genetic variants associated with HM have been described. It also has been described that B lymphocytes of patients with MH have metabolic alterations. The main objective is to evaluate the association of disorders that occur with hypermetabolic response of skeletal musculature and susceptibility to malignant hyperthermia (MH).
Arenaviruses are included in the World Health Organisation R&D Blueprint list of high priority pathogens, since this virus group includes several epidemic-prone highly pathogenic viruses for which there are inadequate diagnostic, therapeutic, and preventative interventions. Junin, Machupo, Guanarito, Sabia, Lujo, and Lassa virus can all cause a viral haemorrhagic fever with high case fatality in hospitalised cases. Lassa fever is the most common severe arenavirus disease and is endemic across many low and middle income countries in West Africa, with an estimated 37.7 million people in 14 countries living in areas at risk of Lassa virus. Despite the discovery of Lassa virus in 1972 and an estimated 300,000 cases and 5000-10,000 deaths annually, there remain gaps in our understanding of the natural history of disease and in the availability of evidence based interventions. The protocol has two components. Sites may implement one or both components. 1. Cardiovascular function in Lassa fever: Lassa fever in humans is often described in the literature as being characterized by vascular leak and shock in the terminal phase, this being the main pathway to death. Whilst animal data supports this, there are very limited data in humans. One of the main aims of this study therefore is to characterize cardiovascular function in patients with Lassa fever, with the ultimate goal of informing future trials of supportive or therapeutic strategies to improve vascular leak. 2. Ribavirin pharmacokinetics and pharmacodynamics: The recommended treatment for Lassa is ribavirin, but its efficacy has not been established in randomized controlled trials and its mechanism of action is not fully understood. There are very limited PK data on ribavirin in patients with Lassa fever and the optimal dose of ribavirin for an RCT has not been established. Furthermore, there are various hypothesized mechanisms of action of ribavirin, none of which have been investigated in humans with Lassa fever. Therefore, further aims of this study are to characterize the PK of ribavirin and ribavirin metabolites (RMP, RDP, RTP) in Lassa fever patients and to identify potential mechanisms of action ribavirin in Lassa fever. Understanding Ribavirin's mechanism of action in Lassa fever is important for the optimal design of a future RCT.
Note that this is a study that is co-sponsored by Medecins Sans Frontieres, Spain, and the University of Oxford. The primary objective is to develop a risk prediction algorithm, combining measurements of host biomarkers and clinical features at the point-of-triage, for children with an acute febrile illness in resource-limited settings. The secondary objectives are to determine which host biomarkers, feasible for measurement at the point-of-care, are predictive of disease severity. Additionally to determine the optimal combination of clinical features (including demographics, anthropometric data, historical variables, vital signs, clinical signs and clinical symptoms), feasible for assessment by limited-skill health workers, that is predictive of disease severity. The tertiary objectives are to explore the impact of different methods of outcome classification on development of the risk prediction algorithm, and to explore the performance of the algorithm to predict disease severity in key presenting clinical syndromes and aetiologies.
Multisite protocol to provide IV Ribavirin treatment to patients with probable or suspected case of Hemorrhagic Fever with Renal Syndrome (HFRS)
This study evaluate the Hyperthermic Intraperitoneal Chemotherapy(HIPEC) in the treatment of Stage IIc-IV epithelial Ovarian Cancer after primary Cytoreductive Surgery (CRS).Half participants will receive HIPEC twice with one intravenous chemotherapy and 5 cycles of intravenous chemotherapy with carboplatin and paclitaxel after CRS. Half participants will receive 6 cycles of intravenous chemotherapy with carboplatin and paclitaxel after CRS.
Hypothesis: Infections other than HIV can cause LN inflammation and collagen damage to the fibroblastic reticular cell network (FRCn), which will lead to CD4 T cell depletion and impaired vaccine responses. This protocol will study yellow fever vaccine (YFV) in two cohorts of people, one from Uganda and the other from Minnesota where we collect lymphoid tissues (LT) and peripheral blood monocytes (PBMCs) before and after vaccination using a new technique to catalog infectious burden of the individual, determine the relationship between IA, Infections, and immune response.
A cross-sectional study on acute undifferentiated fever and the utility of biomarkers in differentiating bacterial from viral infection among acute febrile patients in Gondar, northwest Ethiopia.
This research study aims to examine whether Cryo Cooling packs reduce thermal and cardiovascular strain after exercise-induced hyperthermia compared to a commercially available ice pack. Secondly, the effect of Cryo Cooling packs on cognitive and exercise performance will be examined. There is no current research examining the efficacy of Cryo Cooling packs in hyperthermic individuals and this information will be helpful to establish whether Cryo Cooling Packs can be used for performance enhancement or to prevent heat illness.
A mobile suitcase laboratory for EBOV point-of-care (POC) detection at Ebola treatment centers was successfully implemented in Guinea during the large Ebola virus disease (EVD) outbreak in West-Africa 2014-2015. It was shown that isothermal amplification (Recombinase Polymerase Amplification (RPA)) could be efficiently used to test suspect EVD cases and local teams were trained in and successfully deployed with this fast method. In the frame of this project we want to train teams in DRC and expand RPA testing capacity to the differentials recommended by the WHO. Existing RPA assays for all parameters will be included into a multistrip for simultaneous use. This will be integrated with a simple biosafe extraction method. Implementing this approach and testing in the ongoing EVD outbreak will provide teams in DRC with response capacity for future EVD outbreaks.