There are about 25435 clinical studies being (or have been) conducted in United Kingdom. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The study coordinator aims to compare gold standard deep vein thrombosis (DVT) diagnostic performed by a specialist sonographer to a scan by a non-specialist with a newly developed an automated DVT (AutoDVT) detection software device. The title of the project is: Benefit of Machine learning to diagnose Deep Vein thrombosis compared to gold standard Ultrasound. Currently the process from the DVT symptom begin, to diagnosis and then treatment is all but not straightforward. It implements a laborious journey for the patient from their general practitioner (GP) to accident and emergency (A&E), then to a specialist sonographer. However, handheld Ultrasound devices have recently become available and they have been implemented with a machine learning software. The startup company ThinkSono developed a software which is hoped to divide between thrombosis and no thrombosis. In this single-blinded pilot study, patients which present at St Mary's DVT Clinic will be scanned by the specialist and then by a non-specialist with the machine learning supported device. The accuracy and sensitivity of this device will be compared to the gold standard. This would mean that DVT could be diagnosed at point of care by a non-specialist such as a community nurse or nursing home nurse, for example beneficial for multimorbid confused nursing home patients. This technology could reduce A&E crowding and free up specialist sonographer to focus on other clinical tasks. These improvements could significantly reduce the financial burden for the National Health System (NHS). The AutoDVT has a CE (as the logo CЄ, which means that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards) Certificate under the directive 93/42/ European Economic Community (EEC) for medical devices. It is classified in Class 1 - Active Medical Device - Ultrasound Imaging System Application Software (40873). Furthermore, following standards and technical specifications have been applied: British Standard (BS) European Norm (EN) International Organisation for Standardisation (ISO) 13485:2016, BS EN ISO 14971:2012, Data Coordination Board (DCB)0129:2018, ISO 15233-1:2016.
Lung cancer is responsible for one of the highest incidences of cancer-related mortality globally, and non-small cell lung cancer (NSCLC) accounts for the biggest subtype of lung cancer. In recent years, the use of immunotherapy has revolutionised the management of NSCLC, with better response rates and survival outcomes reported in the literature, compared to traditional cytotoxic chemotherapy. Despite this, doubts remain regarding the true efficacy of immunotherapy in patients > 75 years old, given that this age subgroup is mis-represented in prospective phase III trials, in terms of numbers and baseline functional status, compared to real-world experience. Furthermore, the use of immune checkpoint inhibitors (ICIs) is associated with a spectrum of immune-related adverse events (irAEs), affecting a range of organ systems. Once again, there are doubts about the safety of the use of these agents in patients > 75 years old, and whether baseline performance status and comorbidities are good predictors of efficacy and safety outcomes in this elderly patient subgroup. Comprehensive Geriatric Assessment (CGA) and the vulnerable elders survey (VES-13) are assessment tools that provide a good indication of functional status in elderly patients, in a similar capacity to performance status and comorbidities. This study therefore aims to prospectively examine patients > 70 years old with a diagnosis of NSCLC, commencing immunotherapy. It will assess CGA and VES-13 scores at baseline, and correlate this with certain outcomes such as the incidence of severe adverse effects from immunotherapy at 3 and 6 months, any admissions to hospital arising from immunotherapy toxicities (and the subsequent length of inpatient stay), and mortality within 30 days. In doing so, it will help to determine if CGA and VES-13 scores can be used as a reliable indication of possible future efficacy and toxicity outcomes in this elderly patient subgroup.
This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on male and female study participants reporting with cogntive decline and who in remission from depression.
RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).
The purpose of this study is to determine if crystalline vitamin C supplementation can acutely increase skeletal muscle vitamin C concentrations and if this can be potentiated by administering vitamin C using Phosphycell™ Technology - a phosphatidylcholine-lipid encapsulation technology.
This exploratory pilot study aims to set up cardiac oxygen enhanced magnetic resonance imaging (OE-MRI). It will involve 10 healthy volunteers and 10 patients with known coronary artery disease (CAD) having a MRI scan. If positive, this data would be used to power an appropriately sized study assessing the utility of cardiac OE-MRI in CAD and other cardiac pathologies.
Constipation in children is a common problem. Managing these children is difficult, partly because they do not respond to laxatives and partly because their bowel problem cannot be defined. A "gut transit time" test can add information to help choose the best therapy but this is often not carried out because of the unsuitable radiation dose involved in the current methods such as X-ray. A new Magnetic Resonance Imaging (MRI) method to measure gut transit time using inert mini-capsules, the size of small pine nuts, has recently been developed and successfully trialled during a feasibility study. This main multicentre study will trial the mini-capsules in 436 paediatric constipation patients.
In the Kidney ACTion study, CKD (Chronic Kidney Disease) patients at increased risk of progression to ESRD (End Stage Renal Disease) will be randomly assigned to either standard of care in a specialist nephrology outpatient clinic or to receiving CKD care supported by a novel AI-supported (Artificial Intelligence) software solution.
PQ-504a-001 (Fuchs Focus) is an open-label, single-dose, exploratory study to evaluate safety, tolerability, and corneal endothelium molecular biomarker(s) in subjects with Fuchs Endothelial Corneal Dystrophy with Trinucleotide Repeat Expansion in the TCF4 gene (FECD3).
A unicompartmental (partial) knee replacement (UKR) is the removal of one part of the knee joint (a condyle), that has become damaged due to osteoarthritis, and replacing it with an artificial implant. The placement of these artificial implants and how they are aligned with each other is important because they can impact overall knee function and the long-term survival of the implant. A UKR is a highly effective, recognised procedure for patients with end-stage osteoarthritis affecting one compartment of the knee joint. The functional outcomes following UKA are at a minimum of equivalence to total knee arthroplasty procedures, with some recent literature demonstrating improved functional patient reported outcome scores. There have been significant developments in knee replacement surgery over recent years. In particular, the introduction of robotic surgical systems, such as the NAVIO and CORI systems (Smith+Nephew Plc). These systems are hand-held devices which can support the surgeon with the knee replacement procedure, the systems are image-free and do not require the patient to undergo any scans (such as CT scans). Comparisons of robotic systems to conventional instruments have demonstrated that robotic platforms produce fewer positioning errors in total knee replacement. This can result in more precise knee alignment and better outcomes following surgery. With both the NAVIO and CORI Surgical Systems there is a reduction in radiation exposure due to them being image-free. At present, there is some evidence available for the long-term outcomes of knee replacement implanted using robotic assistance (i.e. 2-10 years) however this study is designed to look at the early outcomes following UKR. There is no literature to date to show that robotic-assisted UKR is superior to conventional methods, within the early post-operative period (up to 12 months). This study is designed to show that the NAVIO/CORI surgical systems are better than conventional methods for UKR. The hypothesis is that they will be cost-effective, will reduce the time a patient spends in hospital following their surgery, will improve patient satisfaction during the early recovery period and will improve the patient's early post-operative mobility and function.