All Clinical Trials in United Kingdom

This is a post-marketing study for B-Lite® implants that carry the EC certificate for marketing in Europe and AMAR certificate for marketing in Israel. To date, thousands of implants have already been implanted in women. The study is open for primary augmentation patients only. All surgeries will be performed as per standard practice at the given study site. No parallel surgical procedures will be performed at the same session. Read Less

InGReS is a phase I pilot study of adaptive dose-escalated radiotherapy in combination with platinum-based chemotherapy (CRT) for locally advanced head and neck cancer. InGReS will assess the feasibility of adapting the radiotherapy (RT) plan for each patient, based on anatomical and metabolic changes in the tumour seen on MRI and FDG-PET-CT performed after 2 weeks of CRT in a multicentre setting. The overall aim of the trial is to determine the safety and feasibility of delivering dose-escalated Intensity Modulated Radiotherapy (IMRT) to the residual primary tumour, as seen on intra-treatment imaging, in the final 3 weeks of RT. Read Less

The aim of this study is to determine if there is any difference in terms of pain relief in patients with frozen shoulder, when given a steroid injection as a suprascapular nerve block compared to a glenohumeral joint intra-articular injection. The investigators hypothesis is that there is a significant difference in terms of pain relief at 3 months, 6 months and 1 year between a steroid injection as a suprascapular nerve block compared to a glenohumeral joint intra-articular injection. Participants who attend the orthopaedic clinic and are diagnosed with unilateral frozen shoulder and who are suitable to be treated with a steroid injection will be identified. If the participant consents to having a steroid injection, he/she will then be invited to participate in the trial where they will have an injection either into the glenohumeral joint (ball and socket joint of the shoulder) or as a suprascapular nerve block (injection adjacent to a nerve over the shoulder blade) under ultrasound guidance. Participants will then be followed up at 3, 6 and 12 months after their injection and asked to complete a set of questionnaires assessing pain, function and movement. The results of the groups will then be compared to see if one treatment is superior to the other. Read Less

The goal of this pilot study and randomised control trial is to compare a smartphone-based exercise programme to deep venous stenting in patients with Post Thrombotic Syndrome. The main questions it aims to answer are: * Is exercise as effective as stenting in these patients? * What type of exercise is useful in these patients? * Can exercise be used to improve the results from surgery? Participants will be split into two groups at random. They will complete a smartphone-based exercise programme or have a deep venous stent. They will do the following tests before and after. * Exercise testing * Calf muscle strength and function tests * Ultrasound of the deep veins * Quality of life questionnaires * Clinical assessment of their disease They will be compared to healthy volunteers in the pilot study. Investigators will compare exercise to stenting to see if it improves symptoms in these patients. The pilot study will help decide how many patients are needed and what exercise tests will be used for the Randomised control trial. Read Less

Preoperative risk assessment (an evaluation of overall health before surgery) is important to determine the overall risk of mortality and complications for patients undergoing major abdominal surgery to allow the appropriate allocation of sparse hospital resources. The current gold standard for preoperative assessment is cardiopulmonary exercise testing (CPET). CPET is, however, not available in all centres that perform major surgery, it is a costly test, and therefore only high-risk patients are tested. Finding new ways of conducting preoperative assessment could improve overall surgical safety, patient experience and reduce cost. The preoperative use of remote vital signs monitoring can provide important information about the patients' fitness and overall health and may be used for preoperative assessment. This study will use a remote monitoring patch to monitor patients' vital signs before surgery. The aim is to evaluate the utility and patient acceptability of the remote monitoring system and the feasibility of a randomised controlled trial of this type of assessment. Additionally, the study will assess the correlation between the data captured by the remote monitoring system and the CPET results to evaluate the remote monitoring system's ability to predict risk of surgery. The study will take place in Leeds Teaching hospitals. Adult patients undergoing major abdominal surgery that require CPET before surgery are eligible. Participants will be monitored at home with the patch monitor for 3-5 days before surgery, in addition to their planned preoperative assessment. During remote monitoring, patients will be asked to complete questionnaires on their general health and experience using the patch paired with the mobile phone as part of the monitoring system. Clinical data from the electronic hospital records and general practitioner records available on the trust system will then be collected after surgery to assess complications and calculate risk scores. Read Less

This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes. Read Less

Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants. Read Less

A case series to provide post marketing evaluation of the MyPAO surgical planning and patient specific guides technology. This will be a single-centre, multi-surgeon evaluation assessing the safety of the use of these guides in periacetabular osteotomy surgery. Read Less

The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals. Read Less

The research team are developing algorithms using artificial intelligence that use information collected by accelerometers to detect a person's position, such as whether an individual is lying, sitting, or standing, and the individual's movements, such as whether they are taking steps or standing up. Sensor location will affect the accuracy of the model and acceptability of the method. The research team are therefore developing algorithms for four different locations. The purpose of the research is for the development of the algorithms and check whether they accurately recognise different positions and movements in people whose movement is affected by a stroke, and by being in a hospital environment (e.g. using a profiling bed). The research team plan to recruit between 34 and 50 participants who are admitted hospital due to having a stroke. After providing informed consent, participants will be asked to complete a one-off assessment with a member of the research team and a ward physiotherapist. Participants will be asked to wear the four sensors, and move through a series of postures, walk for up to six minutes, and stand as many times as they feel able in one minute. Read Less

Recruitment target: Phase I: Co-design of intervention: 5 to 15 CYP aged between 12-18 years of age referred to the pan-London long COVID MDT. Phase II: Randomised pilot: 40 patients (12-18 years) will be recruited from a potential pool of 214 patients referred to the pan-London long COVID MDT. Methods: Phase I: Co-design Design and setting The intervention will be co-designed with CYP following a process informed by practice-base evidence, which centres the voices and wisdom of CYP, focuses on creativity and playfulness, and systemic and narrative approaches. The process will involve: 1) Refining the intentions of key stakeholders (including ways of bringing psychological and physiological principles into the intervention); 2) Participation of CYP; 3) Creativity and playfulness and 4) Responding to feedback (see Salvo et al., 2022). Phase II. Pilot Population: 40 patients (12-18 years) will be recruited from a potential pool of 214 patients referred to the pan-London long COVID MDT. CYP will be randomised to receive either standard treatment or standard treatment plus intervention. Study Treatment Standard treatment consists of virtual MDT discussion with referrer and advice signposting into local services for specific issues. They are sent leaflets and information. If a patient is severely affected enough to be seen face to face, they are offered an interdisciplinary consultation, and tailored input from therapies and psychological services. Access to bite size videos and leaflets covering the following topics: sleep, pacing, activity management, school reintegration, managing friendships, eating well and emotional wellbeing. Young people are invited to a single virtual group Q\&A session to bring any queries after watching the videos. The leaflets and online sessions have been developed by professionals from the Evelina, Great Ormond Street Hospital, Imperial, University College London Hospital, and the Whittington. The bite size videos and live sessions are delivered by a clinical psychologist, a dietitian, specialist nurse, occupational therapist, and physiotherapist. More complex or severely affected patients will receive one to one treatment with members of the MDT as required. Intervention Based on clinical expertise and theory, it is anticipated the following elements may be included in the intervention.: * Progressive breathing pattern retraining, including education, self-observation, relaxation, body scanning, postural re-alignment * Identifying the connections between body and mind to address anxiety and breathlessness * Coping skills for managing anxiety using principles from narrative therapy and mindfulness * Online materials to improve self-efficacy with home practice * Social connection with other CYP for peer support, and resource sharing * Activities to help CYP reconnect with their usual activities, skills, abilities, interests, support systems Read Less

The CARMIGO Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children and young adults aged 2-16 years with Diffuse Midline Glioma (DMG). The study will evaluate the feasibility of generating the ATIMP, the safety and tolerability of the GD2CAR T-cell therapy and how effectively GD2CAR T-cells engraft, expand and persist following administration in patients with DMG. Read Less