EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality
Atrial FibrillationCoronary Heart Disease18 moreHealth inequality and genetic disparity are a significant issue in the United Kingdom (UK). This study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations. The vast majority of drug registration clinical trials have under-representation of ethnic minority populations. In addition, the wider Caucasian populations have reasonably different clinical characteristics to the population that participated in the drug licencing clinical trials. A consequence of this is that drugs are licensed for use in real-world general patient populations where the clinical trial results are simply not statistically significant to specifically demonstrate efficacy or safety in populations that were either absent or under-represented in the drug registration clinical trials. When these facts are considered alongside data that supports significant under-reporting of adverse events in the real-world setting within the UK (and globally, e.g the USA and Europe), it highlights that pharmacovigilance systems are unable to capture drug effectiveness and safety data in a manner that can reasonably assure appropriate prescribing in the wider patient populations. This large real-world research study aims to identify whether commonly prescribed drugs are effective in treating illnesses that cause significant poor health and death in the different patient populations that represent the UK. The goal of this study is to generate large quantitative data-sets that may inform clinical practice to reduce the existing health inequality and genetic disparity in the UK.
A Study of Patients With Chronic Disease
AsthmaChronic Obstructive Pulmonary Disease4 moreTARGET-RWE is a 10-year, international, longitudinal, observational study of patients with chronic disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. The protocol will follow a master protocol design in which a shared study infrastructure supports progressive development of the registry across the spectrum of chronic diseases.
Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease...
Chronic Obstructive Pulmonary Disease ModerateChronic Obstructive Pulmonary Disease Severe2 moreChronic obstructive pulmonary disease (COPD) is a major cause of disability and death worldwide. People with COPD often have cardiovascular diseases (CVDs) that are associated with increased risk for hospitalization and prolonged stay as well as all-cause and CVD-related mortality. Nevertheless, CVDs in patients with COPD are tend to be underestimated in clinical practice. Mechanisms that define the relation between COPD and cardiovascular morbidity include lung hyperinflation, hypoxia, pulmonary hypertension, systemic inflammation and oxidative stress, exacerbation, shared risk factors and COPD phenotypes. Recently, some authors have announced that COPD treatment with dual bronchodilation may not only improve pulmonary function and quality of life, but also have a positive effect on cardiac function in cardiac magnetic resonance imaging (MRI) or two-dimensional cardiac ultrasound for the assessments. The aim of this study is to specify the state of respiratory and cardiovascular systems as well as exercise capacity and quality of life in patients with newly diagnosed moderate-to-severe COPD and to evaluate their changes after short-term treatment with dual bronchodilation. We hypothesize that patients with newly diagnosed COPD and no previous records of cardiac diseases and no apparent signs of heart failure have significantly impaired cardiac autonomic integrity that precedes to increased risk of cardiovascular events. It is believed that cardiac autonomic integrity might significantly improve with dual bronchodilation therapy.
Feasibility of Semaglutide in Advanced Lung Disease
ObesityInterstitial Lung Disease4 moreThe goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease. The main question[s] it aims to answer are: Are patients with advanced lung disease able to tolerate semaglutide therapy? Are we able to titrate semaglutide therapy to a target weight? Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.
Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study
Heart FailureChronic Obstructive Pulmonary Disease6 moreThis is a multicentric, prospective, observational study with two cohorts and adjunctive procedure. It aims at collecting and analyzing data about the function of an innovative hospital-territory integration health service for the management of patients with intermediate urgency, or emergency department "white codes." This service, activated in the participating centers, will be provided in two alternative modalities, one so-called "dual specialty" (cardiology and diabetes specialist outpatient clinic) and a second one more focused on the figure of the specialist in Internal Medicine. The investigators will monitor the population treated in these centers (presenting complaint, medical history, clinical-radiological data, performed therapies and overall health path) and the degree of satisfaction of the General Practitioners who sent their patients there and the degree of satisfaction of the patients themselves. The data collected will also be used to evaluate the effectiveness of the outpatient clinics in terms of reducing improper admissions to the Emergency Departments and hospitalizations. The two modes of service delivery will be compared. This is an 18-month study, sponsored by our Scientific Directorate and carried out on a nonprofit basis. The study will enroll 246 patients and 30 healthy volunteer General Practitioners. The clinical trial will be conducted in accordance with Good Clinical Practice standards.
Respiratory Muscle Function, Diaphragm Thickness and Health Related Physical Fitness Parameters...
Chronic Obstructive Pulmonary DiseaseIn the literature, studies evaluating respiratory muscle function, diaphragm thickness and health-related physical fitness parameters together are insufficient in individuals with chronic obstructive pulmonary disease. In the thesis study, it is thought that the respiratory muscle function, diaphragm thickness, health-related physical fitness parameters, physical activity and lung functions of individuals with chronic obstructive pulmonary disease can be evaluated together to contribute to the literature. The aim of this study is to evaluate diaphragm thickness, respiratory muscle strength, endurance, body composition, aerobic exercise capacity, upper and lower extremity muscle strength and endurance, grip strength, flexibility in individuals with chronic obstructive pulmonary disease and compare them with the healthy group.
Telepalliation - Digital Platform for Patients in Palliation and Their Relatives
CancerHeart Failure2 moreThis project has focus on patients in palliation testing a digital platform TelePal.dk.
Raman Analysis of Saliva as Biomarker of COPD
Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease (COPD) is a debilitating and chronic lung syndrome that causes accelerated lung function decline and death in the 20% of cases. Mostly, the non-adherence to therapy contributes to symptoms increase, mortality, inability and therapies failure, highly influencing the management costs associated to COPD. The existing procedure of diagnosing COPD is effective and fast. The acute treatment and the subsequent disease management, instead, strictly depend on the currently long and complex process of identification of three factors: COPD phenotype, adherence to chosen therapy and probability of exacerbation events. The knowledge of these factors is needed by clinicians to stratify patients and personalise the therapies and rehabilitation procedures, to initiate an effective disease management. The application of Raman spectroscopy on saliva, representing an easy collectable and highly informative biofluid, has been already proposed for different infective, neurological and cancer diseases, with promising results in the diagnostic and monitoring fields. In this project, we propose the use of Deep Learning analysis of Raman spectra collected from COPD patient's saliva to be combined with other clinical data for the development of a system able to provide fast and sensitive information regarding COPD phenotypes, adherence and exacerbation risks. This will support clinicians to personalise COPD therapies and treatments, and to monitor their effectiveness.
Move With Air: Physiological Response Assessment
Chronic Obstructive Pulmonary DiseaseInterstitial Lung Disease1 moreA fan blowing cool air to the face has been shown to alleviate breathlessness in malignant and non-malignant disease at rest and during exercise, however the underlying physiological mechanisms remain unknown. This random order, three-condition design study will explore physiological mechanisms of breathlessness relief with fan-to-face therapy during constant-rate exercise in people with cardiorespiratory disease.
The Use of Wearable Technology to Acquire Signals for COPD Research
Pulmonary DiseaseChronic ObstructiveChronic Obstructive Pulmonary Disease (COPD) is a respiratory condition which affects approximately 3 million people in the UK and 210 million worldwide. The disease is characterized by progressive air flow obstruction and decline of lung function. COPD is currently the fourth leading cause of death in the world. The main reason for hospitalisations associated with COPD is exacerbations (chest infections or a worsening of the underlying symptoms). Severe COPD exacerbations are the second largest cause of emergency admissions in the UK. Mild and moderate exacerbations can be managed in the community but if they are not identified promptly they may progress to breathlessness and in some patients to respiratory failure. Thus, finding modalities for early detection and diagnosis of exacerbations is clearly a priority for current and future COPD research. However, these still do not exist. The aim of this study will be to acquire acoustic respiratory signals from COPD patients with a small wearable device. These signals will be subsequently used to carry out engineering research with the objective of trying to find "fingerprints" in them which could be early indicators of disease exacerbations. If those "fingerprints" were found, subsequent research could focus on trying to create software methods which, together with the use of a small wearable device, would aim at automatically detecting exacerbations when they are at very early stages- prior to the symptoms being evident to the patient- so that clinical intervention could be triggered, in order to optimize the disease outcomes.