All Clinical Trials in United Kingdom

Parkinson's Disease (PD) is a major cause of disability, globally. PD affects a person's movement speed, fluency, quality, and ease of walking. PD has the fastest-growing incidence rate, with its prevalence expected to double over the next three decades, currently affecting 10 million people worldwide. PD often leads to disturbances in walking/gait characteristics such as abnormal/variable stride lengths and step times. Those disturbances increase the risk of falls, with about 39% of people with PD (PwPD) experiencing an average of 20.8 falls/year. Research has examined cueing by leveraging auditory, visual, and tactile cues to normalize variable gait characteristics and improve mobility to reduce falls. Auditory cueing is the most effective at improving gait and most practical to apply in all settings (via headphones) but one size does not fit all when using auditory cueing paradigms i.e., there is a need for personalised approaches to ensure cueing interventions are tailored to the individual and their specific functional limitations. Furthermore, the long-term effectiveness of auditory mechanisms (e.g., metronome-based repetitive beep) suffer from their lack of continuous engagement. This research project aims to examine personalised auditory cueing to improve gait in PwPD. Inertial sensors will capture and analyze validated gait-related characteristics and personalised auditory cues will be examined for their ability to correct variable gait. To reduce burden on PwPD (i.e., minimal number of wearable sensors) and to streamline data capture and deliver auditory cues, a single smartphone will be used only. The project involves a multidisciplinary study between Computing and Exercise and Rehabilitation at Northumbria University, testing cueing modalities in a controlled laboratory environment under trained researcher supervision. The study will enrol PwPD, focusing on the ability of personalised auditory cueing to improve gait and PwPD preference of auditory cues. Read Less

An ankle replacement procedure consists of replacing the worn-out joint surfaces of the ankle with metal and plastic components that are shaped to allow continued movement of the ankle. There are several different types of ankle replacement available. Infinity ankle implants are already routinely used in NHS hospitals. The INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system is a development of the Infinity ankle implant, designed to attach to the bone better and to wear out more slowly. The purpose of the UK ADAPTIS™ Study is to assess the performance and function of the newly introduced INFINITY™ with ADAPTIS™ and EVERLAST™ technology Total Ankle System for total ankle replacement (TAR) or arthroplasty (TAA) and EVERLAST™ Poly Insert that modernises and streamlines Stryker's TAA/TAR portfolio. UK ADAPTIS is a prospective multi-centre cohort series of INFINITY™ with ADAPTIS™ and EVERLAST™ Technology with Poly Insert for patients requiring primary total ankle replacement (TAR) i.e. Total Ankle Arthroplasty (TAA). Patients meeting the criteria for the study will be asked to enrol by providing written informed consent. The patients will be monitored clinically by post-operative follow-up examinations and Patient reported outcome measures (PROMs) (Manchester Oxford Foot \& Ankle Questionnaire (MOXFQ), Ankle Osteoarthritis Scale (AOS), EQ5D-5L). Intended use: It is intended to give a patient limited mobility by reducing pain, restoring alignment, and replacing flexion and extension movement in the ankle joint. Indications for use: * Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. * Patients with a failed previous ankle surgery. Read Less

Phase II, multicentre, randomised, open-label study to assess the benefit of early intervention with fixed duration, time-limited zanubrutinib-rituximab in indolent mantle cell lymphoma (MCL) Read Less

To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU) Read Less

The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant. The main questions it aims to answer are: * Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires * Changes in gut microbiome diversity across all timepoints * Markers of general health, infective/microbiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured. Participants will be asked at their routine follow up visits to, * Provide stool, urine and blood samples at the scheduled study visits * Complete questionnaires at selected visits * Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+/-3 days) Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity. Read Less

Rapid Diagnostic Centres Rapid Diagnostic Centres (RDC) were built to diagnose patients who have common symptoms that occur in cancer, but it is unclear if they have cancer or not. These symptoms include: * Weight loss * Fatigue * Cough * GP suspicion Only 1 in every 10 patients (10%) referred to an RDC will have cancer. Some of the patients with cancer may have been more likely to develop cancer due to inherited or environmental factors. Some of the patients who don't have cancer may also be at higher risk of developing cancer at another time due to inherited or environmental factors. Aims The goal of this observational study is to develop a new blood or non-blood test that could help doctors at RDC: * detect which patients have cancer through a simple and quick blood or non-blood test * detect patients who are at higher risk of having cancer. This is so they can be monitored or guided towards cancer-screening programmes Main End Points * The study will be considered a success if a test or mixture of tests is developed that can correctly sort patients into cancer or non-cancer groups. * Also, the study will be considered a success if a test or mixture of tests can show what type of cancer a patient has if they have cancer. Tests To create this new blood or non-blood test the study will take the following samples from 1000 patients in the RDC Biomarker Study: * Breath samples (around 300 patients) - People with cancer have different levels of chemicals in their breath than people without cancer. The study hopes to develop a breath test which could show if a patient has cancer or not. * Blood samples ( around 1000 patients) - The study hopes to develop a blood test that could show if a patient has cancer or not * Saliva samples (around 1000 patients) - For many cancers, while there is a genetic component there is no one single gene that causes cancer. Instead, it can be a combination of hundreds of genes that causes the risk of cancer in a person to go up. The study hopes to develop a test which could provide a risk score. This risk score is called a 'polygenic risk score' which would tell doctors how likely a patient is to get cancer. Method Patients who meet the criteria to be able to join the study will be asked either via telephone before their appointment, or face-to-face at an appointment at the RDC if they would like to join the study. If they agree to join the study they will read a patient information sheet and sign a consent form to say they understand what the study requires. The patient will then provide blood and saliva samples and in some cases breath samples at their first appointment. They will be then asked to provide further samples (up to three) at their follow-up appointments. Please see below for samples that will be asked for at each appointment: First appointment: Breath (not all sites), Blood, Saliva (not all sites), Survey Follow-up 1: Any samples that could not be taken at the first appointment Follow-up 2: Any samples that could not be taken at the first appointment The patient will be provided with a Study ID to identify their samples. This is a unique code to identify each person on the study. Only the site that recruited the participant will have access to the personal information that matches which patients is known by which Study ID. All organisations external to the site will only know the patient as the Study ID. An example of the study ID could be RDCRMH001. A trained clinical member of the research team at the RDC will take the sample and ship it to the relevant laboratory for testing. As well as blood and non-blood tests, information about the patients will be collected This includes routinely collected clinical data alongside investigation results. No patient identifiable information such as: * Name * Address * Date of birth * Contact details will be collected, and a Study ID will be used to identify the data. A patient questionnaire will be sent out to patients to complete for each appointment asking questions about the patient's health. The RDC doctors treating the patient will see survey answers before the appointment to allow them to act about anything worrying. For a small group of patients anonymised copies of thier scans from their medical records will also be taken. Study Duration Once the study has recruited 1000 patients, it will close to recruitment. These patients will then be followed up for 12 months following the date they joined the study. Read Less

1. What will happen to me if I take part? All study visits will be at the University of Glasgow main campus within the Sir James Black building. Initial visit (duration 1 hours) We will ask that for each study visit you come to the laboratory with clothing suitable to exercise in (loose shorts) for your own comfort and to also make it easier for us to complete certain measurements where access to upper legs will be necessary. Changing facilitates will be provided on-site. After the screening process, your physical activity and your diet will be assessed via questionnaires. We will then familiarise you with the physical function tests and neuromuscular measurements. Visit 2 (duration 1 hours) Before the remaining study visits in the morning, you will be asked to arrive at the laboratory after an overnight fast (no food or caffeinated/calorific beverages from 10pm), and without having done intense exercise for two days prior to the visit. Upon arriving in the laboratory, we will collect a blood sample (after which we will provide you with a snack), and measure your body composition, muscle size, muscle strength and physical function. You will then be familiarised with the resistance training protocol, and we will determine your maximum strength for two leg exercises. After these measurements are completed, we will randomly assign you to consumed 2g/day of either krill oil or a mixed vegetable oil. Visit 3 (duration 3 hours) After 8 weeks of supplementation, you will attend for a third study visit. This will involve a blood sample and repeating the same measures from the baseline visit with the addition of a measurement of soreness in the upper legs. We will then ask you to complete muscle-damaging exercises consisting of a warm-up of 5 minutes of downhill walking (5% decline at a self selected speed between 3-6 km/h) followed by 4 sets of machine exercises of both leg kicking and leg pushes. These leg exercises will be performed at \~70% of your maximum strength and we will ask you to perform as many repetitions as you can, with the last two sets of each exercise also consisting of 4 extra lowering repetitions. Five minutes and 60 minutes following the muscle-damaging exercise, all the measurements, including blood samples, will be repeated. Visit 4 (duration 1 hours) Two days after visit 3, we will once again repeat the measures taken on visit 3 for a final time. Measurements Blood sample: A blood sample (15ml) will be collected from a vein in your arm by a trained member of the research team. Muscle size: We will use an ultrasound to assess muscle thickness of one of the muscles on the outside of your legs. Muscle strength: You will sit in a chair with your legs at a 90-degree angle. A strap will be placed around the right ankle which will be connected to a force sensor and three sticky surface electrodes will be placed on your thigh. We will then ask you to contract as hard as you can with the leg fixed in position, and we will record the force for 5 seconds. You will perform 3 contractions, with a 1min rest between contractions. After the maximal contractions, will be ask you to contract at 20, 35 and 50% of your maximal effort for 15 seconds so that we can record electrical activity in your muscle. We will then stimulate a contraction with a small electrical current at rest and during a maximal contraction. We will also measure grip strength, making 3 measures from each hand. We will measure your strength on exercise machines, for both leg kicking and leg pushing. Following a warm-up, the weights on each machine will be progressively increased in until you cannot do any more. Physical function: We will ask you to rise from a chair 5 times and to walk a distance of 4 metres and record how long this takes. We will also ask you to stand for 10 seconds with your legs in 3 different positions. These will be demonstrated to you before you do this. Body composition: We will measure total fat and lean mass using bioelectrical impedance analysis. Soreness: We will ask you to mark on a line how sore your muscle feels to measure muscle soreness before and immediately after the muscle damage protocol in two different tests. In the first test, we will apply a fixed, moderate amount of pressure on your thigh and we will ask you how sore it feels; in the second test, we will apply an increasing amount of pressure until on your thigh until you tell us it feels sore. Read Less

The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and/or serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils. Read Less

To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions. Read Less

This is a longitudinal observational study recruiting individuals that have attended three clinical sites with symptoms associated with a diagnosis of long COVID, PTLDS or ME/CFS. The study will be a multi-centre study, with up to 160 male and female participants enrolled. Participants that experience symptoms considered to be associated with a diagnosis of long COVID, PTLDS or ME/CFS will consent to the study, and attend for two study visits (at study entry and 6 months) to complete a questionnaire related to their symptoms, and to have a blood sample taken. Blood samples will be taken either at the clinical site or at the participant's home if they are unable to attend due to the severity of their illness. . Participants will be allocated to one of the following groups: Group 1: Long COVID Group 2: ME/CFS Group 3: PTLDS Group 4: Healthy Control Read Less

Rehabilitation robotics has the potential to facilitate rehabilitation at home and empower people with spinal injuries to self-manage increasing their independence and improving their quality of life. The objective of this study is to assess for the first time in the NHS the efficacy of a commercial robotic orthosis for upper limb rehabilitation in patients with spinal cord injury. The device is produced by Myomo (myomo.com) which is an American company. We will be assessing the wearable robotic orthosis also known as robotic exoskeleton in two different neuro-rehabilitation centres: National Spinal injuries Unit in Glasgow (Scotland) and The Robert Jones and Agnus Hunt Orthopaedic Hospital in Oswestry (England). The study will involve nine spinal cord injured tetraplegic inpatients in total. Patients will follow a twelve-week rehabilitation programme with three to four sessions per week in addition to their usual care and rehabilitation. Each session lasts for approximately 45 minutes. Participants arm function, range of motion, spasticity level will be measured before, half-way and at the end of the programme to assess change in these and other parameters. Training will focus on the dominant arm of the patient and compared to the other arm at every assessment stage. We shall evaluate therapists' and patients' satisfaction with the commercial device in addition to assessing various clinical measures to evaluate the efficacy of using the robotic orthosis in rehabilitation and recovery of arm function. Read Less

Streptococcus pneumoniae (pneumococcus) is a bacterium that causes just under four million serious infections every year. It is normal for pneumococcus bacteria to live in the noses of healthy adults and children as part of the nasal microflora without causing harm. This is called "carriage". But the bacteria can still be passed on to other people. If they are at-risk, for example elderly, or very young, or have pre-existing health conditions, the pneumococcus bacteria can cause pneumonia, which can cause serious life-threatening illness. Pneumococcus bacteria are surrounded by a sugar capsule. But the capsule does not always have the same components. As a result, the bacteria are classified into more than 100 different types. To make them effective, the vaccines that are currently available contain the sugar capsules of the most common pneumococcal types that cause disease. One such vaccine - PCV13 - has been effective globally in protecting against pneumococcus disease. It works because it controls the "carriage" (how a person carries the bacteria in their nose) of 13 types of the bacteria. Vaccines giving protection against other types of the bacteria are also becoming available worldwide. PCV15 is similar to PCV13 and protects against two additional types of the bacteria so may offer more protection. This study, which lasts 2 months and is funded by Merck Sharp \& Dohme (MSD), aims to assess if using PCV15 can protect against "carriage". To do this, investigators will use a well-established method already used with more than 2,000 people safely in other research. This involves "challenging" volunteers by putting a small amount of the pneumococcus bacteria into their noses. In this study, before they are challenged, volunteers will either be vaccinated with the real PCV15 vaccine or a dummy ("placebo"). The Investigators will then be able to compare the two groups to find out who the vaccine protected and who it did not. After the study everyone who takes part and fit into certain criteria will be given antibiotics to clear the pneumococcus colonisation. They will also be regularly monitored during the study to ensure their safety. A very small number of volunteers will be asked to have a biopsy to collect tissue samples from inside their nose before and after being vaccinated with PCV15. This will help researchers to understand more about how the immune system responds to the vaccine. The information gain in this project will help the investigators to understand how exactly PCV15 vaccine protects people against pneumococcus. This means that this vaccine and future pneumococcal vaccines will be improved to protect many lives in future around the world. Read Less