All Clinical Trials in United Kingdom

Sarcopenia is a progressive muscle disease, most commonly affecting older individuals, that is categorised by 1) low muscle strength, 2) low muscle quantity or quality, and 3) low physical performance. This disease has several negative implications for human health, including an increased risk of falls, fractures, mobility limitations, and mortality. Sarcopenia also imposes significant burden on healthcare systems. For example, it was estimated that a 10% reduction in the prevalence of sarcopenia would save the US healthcare system $1.1 billion per year. Strategies to reduce the incidence and severity of sarcopenia are therefore of great interest. One potential cause for sarcopenia is long-term, low-level inflammation, which can occur for a number of reasons. One cause may relate to the intestinal wall becoming more susceptible to leaking of toxic particles. Evidence suggests that prebiotic supplementation can reduce this 'leakage'. Galactooligosaccharide (a prebiotic) has previously been shown to reduce inflammation in elderly individuals. The investigators hypothesise that galactooligosaccharide will improve physical function in the elderly indirectly via a reduction in inflammation. This will be a randomised, placebo-controlled, double-blind, parallel study. 32 elderly individuals (65-85 years; mix of males and females) will be randomised to one of two groups, GOS or PLACEBO. The GOS group will supplement their diet with 2.9 g galactooligosaccharide per day for 16 weeks in the form of one sachet (3.65 g) of Bimuno® Daily. The PLACEBO group will supplement with 3.65 g maltodextrin per day for 16 weeks. The study will involve one screening visit and two main trials (baseline and 16 weeks). For the main trials, participants will complete the short physical performance battery (SPPB) and handgrip strength test. In addition, participants will provide blood, urine and faecal samples, as well as a dual-energy x-ray absorptiometry (DEXA), and a peripheral quantitative computed tomography (pQCT) scan. Read Less

Individuals attending the hospital to undergo operations are at risk of developing blood clots in the legs, known as deep vein thrombosis (DVT). A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lungs' ability to move oxygen from the air into the blood and may be life-threatening. This is known as pulmonary embolism (PE). DVT and PE are known collectively as venous thromboembolism or VTE. The importance of preventing VTE in surgical patients is widely recognised, with two main strategies used: thinning the blood with regular injections and/or tablets and wearing elastic stockings to help stop blood from sitting in the leg veins where it can clot. Evidence for using elastic stockings to prevent VTE has recently been challenged. Additionally, there is a lack of evidence for the additional benefit of stockings over and above that of blood thinning medications. If stockings were to reduce VTE over and above blood thinning medication, these benefits need to be weighed against the risks and disadvantages of stockings, including discomfort, restricting blood flow to the leg causing blisters and wounds in addition to the cost. If stockings were found not to reduce the risk of clots, they would no longer need to be used in these patients, thus reducing the disadvantages of stockings, and saving the NHS millions of pounds per year. Certain types of operations (300,000 per year in the UK) are linked with a particularly high risk of VTE, including cancer surgery, surgery in the abdomen and pelvis, and bone (orthopaedic) surgery. In these cases, patients are offered blood thinning medications both during their hospital stay and for a period after they have left the hospital. Furthermore, these patients are offered stockings to wear while in the hospital. It is not known if, in patients who receive blood thinning medications both in hospital and after discharge, the addition of wearing stockings whilst in hospital reduces their risk of VTE any further. The purpose of this study is to investigate if it is worthwhile using stockings, in addition to blood thinning medication, to reduce blood clots after surgery. People enrolled in the study will be those at the highest risk of VTE and require an extended period of medication to reduce the risk of a blood clot. A computer will randomly choose one of the below treatments by chance to make the trial fair: A) Extended duration clot-reducing medicine in addition to stockings B) Extended duration clot-reducing medicine alone The surgery and all the other medical care will continue as normal. Everyone in the study will get an ultrasound scan at 21 - 35 days after their operation to check if they have developed a blood clot. This is an additional scan, not routinely performed in the NHS, to make sure that all blood clots are detected at an early stage. Participants will receive a phone call at 7, 21-35 and 90 days after their treatment to see if they have developed a blood clot or had any problems with the treatment. Read Less

The proposed study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of delivering self-acupuncture within an NHS cancer care setting. The trial will explore the feasibility and acceptability of all aspects of a definitive clinical trial of teaching cancer patients to self-administer acupuncture to alleviate symptoms of cancer and the side effects of conventional chemotherapy treatment. In addition the feasibility trial will provide preliminary data on effectiveness to inform the sample size calculation for a controlled clinical trial. Patients will be randomly allocated to receive either: 1) self-acupuncture in addition to standard care or 2) standard care alone. Participants randomised to the self-acupuncture arm will be asked to attend a 1.5 hour group workshop delivered by an experienced practitioners and teachers of self-acupuncture. Participants allocated to standard care will be offered training in self-acupuncture once the trial is complete to address any ongoing side effects from their cancer and its treatment. Patients will be recruited at the initiation of their chemotherapy cancer treatment from UCH Macmillan Cancer Centre. Participants will complete baseline outcome measures and be asked to complete follow up outcomes measures at the end of chemotherapy treatment, and 3 months post chemotherapy treatment. At the end of chemotherapy treatment participants will also be asked to take part in a qualitative telephone interview to explore their views on the design of the study and if allocated to self-acupuncture their views on the intervention. At 3 months post chemotherapy treatment those allocated to self-acupuncture will be invited to participate in a second qualitative interview to explore the long-term practice and effects of self-acupuncture. Qualitative interviews will also be conducted with stakeholders (acupuncturists delivering workshops and UCH Macmillan Cancer Centre staff) to explore their views on the feasibility of teaching cancer patients self-acupuncture. Read Less

The Canadian Australasian Randomized Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease (CARSK) will test the hypothesis that eliminating the regular use of non-invasive screening tests for CAD AFTER waitlist activation is not inferior to regular (i.e., annual) screening for CAD during wait-listing for the prevention of Major Adverse Cardiac Events. Secondary analyses will assess the impact of screening on the rate of transplantation, and the relative cost-effectiveness of screening. Read Less

A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death, with higher risk among people living with frailty. National recommendations suggest that medications taken by frail older people should be reviewed annually by GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines. Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs. This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication reviews. There are four work packages (WPs). 1. Review literature to identify what makes a successful medication review and how to safely deprescribe. 2. Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will investigate where medication review should take place, the role of involved parties, type of medications that could be deprescribed, staff training needs, barriers and facilitators for implementation, and strategies to address them. 3. Information from WP1\&2 will be used to develop the intervention: a structured medication review process using pharmacists, ANPs and GPs and involving frail patients and their families in decisions about medications. This will be refined through workshops with service users, clinicians and commissioners. A training programme to implement the intervention and increase staff confidence in deprescribing will be developed alongside the intervention. 4. Feasibility study for staff in four GP practices to be trained and to implement the intervention.(this will be subject to further amendment). Read Less

The purpose of this small-scale exploratory study is to bridge the knowledge gap between the bench testing and the design of potential future confirmative studies. Identifying and evaluating MicroEMG measurement parameters in this exploratory manner is a necessary step to evaluate its usability and design, and determine whether the microEMG system may be suitable for in-house use after further confirmative testing. Read Less

This study aims to investigate if MR Enterography (MRE) improves the ability to predict which Crohn's disease patients will relapse quickly (disease comes back) after stopping biologic medication. MRE is a safe MRI scan of the bowel, widely used in Crohn's disease patients. Read Less

This is an observational longitudinal study to determine the natural history and genotype-phenotype correlations of disease causing mutations in Charcot Marie Tooth disease (CMT) type 1B (CMT1B), 2A (CMT2A), 4A (CMT4A), and 4C (CMT4C). The investigators will also be determine the capability of the newly developed CMT Pediatric Scale (CMT Peds scale) and the Minimal Dataset to measure impairment and perform longitudinal measurements in patients with multiple forms of CMT over a five year window Read Less

The primary goal of this project is to develop and test a Charcot Marie Tooth disease (CMT) Pediatric Scale for use in evaluation in natural history CMT study. Read Less

Historically, cancer research has been limited by sample acquisition in late stage disease, often restricted to single sites of disease with limited parallel clinical data collection in terms of prior therapy exposure. The PEACE study is intended to facilitate tissue donation from multiple tumour sites in the post-mortem setting and enable future research using samples collected at post-mortem within different disciplines related to cancer research. Read Less

Waldenström's macroglobulinaemia (WM) is a rare type of slow growing lymphoma. It develops when white blood cells grow abnormally. Typically a disease of the elderly, the median age of presentation is \>70 years and the current treatment for WM is unsatisfactory, with incomplete responses and inevitable recurrence. Therefore there is a need to find alternative treatments that are more effective, leading to lasting responses and improved quality of life. The RAINBOW study is a phase 2-3 trial assessing 'chemotherapy free' treatment as primary therapy for WM which can potentially improve response outcome, durability and importantly, reduce toxicity for WM patients. This approach will be done using the drug Ibrutinib, which in combination with rituximab (RI) will be the experimental arm. As there is no agreed standard on first-line therapy for WM, the control arm is the current treatment based on the most recently published clinical trial results. The control arm consists of rituximab, cyclophosphamide and dexamethasone (DCR), and is widely recommended by international consensus as appropriate treatment for first-line therapy for WM. In this study, 148 adults (aged ≥ 18 years) with treatment naïve WM will be randomised on a 1:1 ratio to either the treatment or control arm. Randomised treatment lasts for a maximum of 6 cycles and response will be assessed following 3 cycles of treatment and completion of randomised treatment at approximately 24 weeks after commencing treatment. RI patients may then have up to 5 years of Ibrutinib monotherapy. Patients will be seen regularly during treatment and then every 3 months for 5 years after treatment discontinuation. Patients will enter annual follow up for survival until the end of trial (including progressed patients). The study will be conducted at NHS hospitals and is expected to last 9 years and 6 months. Read Less

This clinical trial is evaluating the drug candidate TT-702 in patients with advanced solid tumours. The main aims of the trial are to determine the maximum dose of TT-702 that can be given safely to patients alone and in combination with other anti-cancer agents. Read Less