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.
Comparison of home versus hospital Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS). TPTNS has been shown to be an effective treatment of overactive bladder in hospital. We aim to see if this effect is replicated at home. 80 patients will be recruited, 40 into each arm. Inclusion criteria: 1. Women aged ≥18 years 2. Clinical diagnosis of Overactive Bladder (OAB) 3. Post-void residual urine volume of < 100ml 4. Able to do questionnaires 5. Able to consent and willing to participate Exclusion Criteria 1. Cardiac pacemaker in situ 2. Leg ulcer/skin condition affecting both lower legs 3. Diagnosed peripheral vascular disease 4. Absent sensation at the electrode site 5. Current Urinary Tract Infection (UTI) - must be treated with appropriate antibiotics as per the unit protocol prior to commencing study 6. Pregnancy 7. Previous Percutaneous Tibial Nerve Stimulation (PTNS) /Sacral Nerve Stimulation (SNS) course 8. Previous intravesical botox treatment 9. Unable to complete questionnaires TPTNS will be taught to the home group and delivered to the participants in the hospital group in individual appointments: 12 treatment sessions of 30 minutes duration, delivered twice weekly over a 6 week period. Two surface electrodes are applied to the right ankle. These electrodes are attached to an electrical stimulator, programmed to safely deliver electric pulses. On completion of 6 sessions, all participants will be contacted and asked to do a Patient Global Impression of Improvement Scale (PGIIS) and Patient Perception of Bladder Condition (PPBC). After 12 sessions (the final treatment session) all participants will be reviewed by the investigators in the hospital and the outcome measures repeated. Participants receiving home treatment will be posted out a 3 day bladder diary to complete. At this point the participants receiving home treatment will return the machine. All participants will complete and return a 72-hour bladder diary and validated questionnaires routinely used at the study centre to measure lower urinary tract symptoms - The International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) long form, the International Consultation of Incontinence Modular Questionnaire - Urinary Incontinence questionnaire (ICIQ-UI short-form. The Hospital Anxiety and Depression Scale (HADS) and the European Quality of Life - 5D Questionnaire (EQ-5D) will also be measured.
The purpose of PERMIT is to collect information on the treatment of radiotherapy patients using a new radiotherapy machine that includes magnetic Resonance (MR) imaging (MR linac) to guide treatment. The aim is to use this information to support the introduction of MR Linac into clinical practice. PERMIT will collect details on patients treated on the MR linac plus details on their side effects and other outcomes. This information plus technical and imaging information will be combined with information from other centres using this machine. By doing so this will help us learn how best to use the MR Linac in the future and design new radiotherapy protocols
This study is a multi-centre interventional study at seven tertiary paediatric surgery centres in Ghana, Zambia, Malawi and Tanzania aimed at reducing mortality from gastroschisis.
Currently, there is no accurate measurement of dietary intake. All current methodologies of assessing dietary intake have inaccuracy rates of 30 -70%. Accurate assessment of dietary intake is critical in understanding individual and population nutritional status and monitoring the effectiveness of public health interventions to maintain nutritional health. Estimating dietary intake in low and middle-income countries (LMICs) is remarkably challenging, albeit the high presence of malnutrition and the critical need for evidence-based data to inform policies and programmes on nutrition and health. This study aims to develop and validate a low-cost and robust system for accurate measurement of an individual's dietary intake in households in LMICs. This innovative system passively recognises food, records intake, and estimates nutrient content of food. The system will be validated in field trials in Ghana and Kenya.
Objectives: This is a feasibility study in preparation for the main multicentre randomised trial, which is anticipated to have two arms: - Arm A: the current best standard of care [rehabilitation exercises] - Arm B: the current best standard of care [rehabilitation exercises] + the experimental intervention In this feasibility trial the following aspects will be evaluated: - Recruitment rates [that is also willingness to be randomised] - Feasibility of providing the experimental intervention at the NHS study sites - Retention rate/drop out rate - Feasibility and acceptability of (i) proposed primary outcome [patient-centred], (ii) a range of additional patient-centred and clinician-centred outcomes - Standard deviation of the proposed primary outcome so to inform sample size calculation of the main trial. - Safety/toxicity of the study medication. Type of trial: Multicentre, parallel group, randomised controlled trial in 50 patients with radiotherapy-induced fibrosis of the head and neck. Trial design and methods: Participants over the age of 18, with radiotherapy-induced fibrosis of the head and neck will be given information about the trial and invited to participate. 50 participants who consent will be recruited and randomised to either: - Treatment with pentoxifylline 400 mg tablets twice a day [total 800mg/day] + 500IU tocopherol acetate solution twice a day [total 1000 IU/day] in addition to best standard care [a structured programme of rehabilitation exercises] for 6 months or - Best standard of care [a structured programme of rehabilitation exercises] for 6 months. Randomisation will be carried out online Trial duration per subject: 6 months Estimated total trial duration: 56 months Planned trial sites: Multi-site Total number of subjects planned: 50 participants Main inclusion/exclusion criteria: Inclusion Criteria: - Subjects aged ≥18 years - Previous history of Head & Neck Cancer - Previous radiotherapy to the Head & Neck - minimum 50 Gy completed at least 12 months before screening visit - Cancer-free for a minimum of 12 months after completion of radiotherapy. - Diagnosis of radiotherapy-induced fibrosis of the head and neck: trismus and/or dysphagia Exclusion Criteria: - History of primary cancer resection and/or reconstructive surgery to anatomical areas involved in swallowing and/or chewing. - Concomitant presence of other disorders that may cause pharyngeal/oral fibrosis - Known hypersensitivity to pentoxifylline or tocopherol (vitamin E). - History of acute porphyrias or haemorrhagic disorders - Active/ongoing hypotension - Diabetes - Pregnancy - Subjects with osteoradionecrosis - Breastfeeding mothers - Subjects with a MIO <12mm Statistical methodology and analysis: Analysis of this feasibility trial will be mainly descriptive, measuring recruitment rate, acceptance of randomisation, attrition from treatment and trial, and completion rates for the outcome measures (to gauge acceptability and appropriateness).
The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
A registry to audit the current range of applications, technical success rate, safety profile, complication rate and efficacy of cryoablation procedures being performed in children.
Trial Title: FiTNEss (UK-MRA Myeloma XIV) - Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma Overview: A phase III, multi-centre, randomised controlled trial to compare standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with the novel triplet ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide (R) to lenalidomide plus ixazomib (R+I) in patients with newly diagnosed multiple myeloma not suitable for a stem cell transplant. All participants receive induction treatment with ixazomib, lenalidomide and dexamethasone and are randomised on a 1:1 basis at trial entry to the use of frailty score-adjusted up-front dose reductions vs. standard up-front dosing followed by toxicity dependent reactive dose-modifications during therapy. Following 12 cycles of induction treatment participants alive and progression-free undergo a second randomisation on a 1:1 basis to maintenance treatment with lenalidomide plus placebo versus lenalidomide plus ixazomib. Participants and their treating physicians will be blinded to maintenance allocation. Participant population: - Newly diagnosed as having Multiple Myeloma (MM) according to the updated IMWG diagnostic criteria 2014 (see Appendix 1 for criteria) - Not eligible for stem cell transplant - Aged at least 18 years - Able to provide written informed consent Number of participants: 740 participants will be entered into the trial at Randomisation 1 (R1), with 478 participants at Randomisation 2 (R2). Objectives: The primary objectives of this study are to determine: - Early treatment cessation (within 60 days of randomisation) for standard versus frailty-adjusted up-front dosing - Progression-free survival (PFS, from maintenance randomisation) for lenalidomide + placebo (R) versus lenalidomide + ixazomib (R+I) The secondary objectives of this study are to assess progression-free survival (PFS) for standard versus frailty-adjusted up-front dosing reductions, time to progression, time to 2nd PFS event (PFS2), overall survival (OS), survival after progression, deaths within 12 months of R1, overall response rate (ORR), attainment of ≥VGPR, attainment of MRD negativity, duration of response, time to improved response, time to next treatment, treatment compliance and total amount of therapy delivered, toxicity & safety including the incidence of SPMs, Quality of Life (QoL), cost effectiveness of standard versus frailty-adjusted up-front dosing of IRD and cost-effectiveness of R + I versus R. Exploratory objectives are prospective validation of a novel frailty risk score (UK-MRA Myeloma Risk Profile - MRP), usefulness of Karnofsky Performance Status (PS), and association of molecular subgroups with response, PFS and OS.
There are around 115,000 people in the United Kingdom suffering with Crohn's Disease (CD). CD can cause inflammation and ulcers to develop anywhere within the gut. Symptoms of the disease include diarrhoea, abdominal pain and nutritional problems including vitamin D deficiency. Around half of people with CD are likely to have vitamin D deficiency. Research has shown that treating vitamin D deficiency in people with CD might help to improve the symptoms of the disease. However, there are no clear guidelines on how to detect or treat vitamin D deficiency in people with CD. There will be two parts to the planned research involving three hospitals in Birmingham. Part 1 is a vitamin D screening study, where adults will be asked to have a finger-prick blood test to check their vitamin D levels. They will complete short diet and lifestyle questionnaires. Adults found to have vitamin D deficiency in part 1 may be invited to join part 2 of the research. Part 2 is a vitamin D supplementation study where participants will be given a daily vitamin D capsule to take by mouth for 6 months. They will be randomly allocated to 2 different groups with each group receiving a different dose of vitamin D. Participants will have blood tests at the start, after 3 months and after 6 months. They will complete quality of life questionnaires at the start and after 6 months. The last appointment will be a final follow up appointment after 9 months. This research is important to help determine: - Which dose of vitamin D is most effective at treating vitamin D deficiency in people with CD - If symptoms of CD improve when vitamin D deficiency is treated.
This study aims to investigate the clinical response to Spinal Cord Stimulation frequency parameters: 40Hz, 4000Hz and 10000Hz and explore the brain imaging changes using PET-CT scans. The response to these stimulator settings on health related quality of life will also be measured using validated questionnaires.