All Clinical Trials in United Kingdom

After a surgical operation patients may have an infection in the operation wound, the bladder, kidneys or lungs. To stop these infections patients are given a dose of antibiotic before their operation. Unfortunately, the amount of antibiotic available to fight infections falls throughout an operation, being removed from the body by the kidneys. Therefore, antibiotic levels may not be high enough to stop infections. A way of maintaining antibiotic levels throughout an operation is to give a single dose of antibiotic and then a constant amount of antibiotic by an infusion from the start to the end of the operation. A small single centre test study was previosuly undertaken into antibiotic dosing during bowel operations. One group of patients had a single dose of antibiotic before their operation. The other group had a single dose plus a constant dose of antibiotic until the end of their operation. The project showed patients were happy to take part and that the study was safe. The study helped us identify the correct amounts of antibiotic needed for the patients given the single dose plus a constant dose of antibiotic. This study was conducted at one hospital only, and wasn't big enough to confirm if one treatment was better than another or if results would be similar in other hospitals. This study will build on the pilot study in a larger feasibility trial, the Colo-Pro_2 trial. It will be run in three hospitals so can assess if the trial design works at different hospitals. We will see if the results suggest one treatment, single dose of antibiotics before an operation, or single dose plus a constant dose of antibiotics throughout an operation, is better. This study will include up to 180 patients having bowel operations as they have a high risk of infection. All patients will be given the same antibiotic which is called cefuroxime. Cefuroxime is already used to stop infections after surgery. Using the same antibiotic in all patients means it is possible to know if differences in the number of infections are due to how the antibiotic is given. The number of infections that happen up to 30 days after operations will be counted. Staff looking after patients after the operation and those counting the infections will not know, unless necessary, the treatment patients received. This means the results won't be influenced by knowledge of the treatment received. Read Less

Trial Design: This is a feasibility randomised controlled trial. Aim: The study aims to assess the feasibility of conducting a randomised controlled trial using a digital health tool (Keep-On-Keep-Up Nutrition, KOKU-Nut) to improve dietary intake in community-dwelling older adults. Objectives: 1. Is it feasible and practical to run KOKU-Nut study as a powered randomised controlled trial. 2. Adherence to the intervention, motivations, barriers and facilitators of engaging with KOKU-Nut Study population: Community-dwelling adults aged 65 and older Intervention: Participants in the intervention group will be asked to engage with KOKU-Nut at least 3 times a week throughout the 12-week period. A crib sheet and contact details for the research team will be available if participants require additional support to help with technical issues. Control: Participants will continue with usual care and receive a leaflet developed by Age UK about the importance of a healthy lifestyle. Timing and duration 3 month intervention with interviews carried out approximately one week after the intervention period Read Less

The aim of this study is to perform a double-blind, randomised, dose-response trial of vitamin D3 supplementation in United Kingdom (UK)-dwelling adults of white European, South Asian, and black African/Caribbean ethnicity to investigate the distribution of dietary intakes needed to maintain adequate vitamin D status in winter, as indicated by serum 25(OH)D concentrations at ranges of \>25 to 50 nmol/L. In addition, this study will investigate the effect of vitamin D3 supplementation on immune health, muscular strength, and overall health. Read Less

This clinical trial's primary aim is to investigate the acute effect of two exercise bouts (short \[10 minutes\] and long \[30 minutes\]) on appetite and appetite-regulatory hormone responses to a standard meal test. The secondary aim is to investigate when the changes in appetite and appetite-regulatory hormones occur during exercise. As an exploratory aim, the researchers will test if the two exercise bouts influence ad libitum energy intake in the periods after the standard meal test. The researchers will compare three groups (control, short exercise, and prolonged exercise) to see if the exercise bouts affect appetite, appetite-regulatory hormones, and energy intake in healthy men. Read Less

The aim of the study is to investigate the effects of 28 days supplementation of Lions mane mushroom and mushroom blend of Lions mane and reishi mushroom, on wellbeing in stressed or anxious women. The study will follow a randomized, double-blind, placebo-controlled, parallel group design. Participants will receive either lion's mane mushroom mane (1.8 gram per day, consisting of 3 x 600mgcapsules), a blend of lion's mane mushroom and reishi mushroom 1.8 gram per day, consisting of 3x600mg capsules) or placebo (1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules). The trial will utilise Generalised Anxiety Disorder Assessment (GAD-7); the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS); Chalder Fatigue Scale; Rosenberg's Self-Esteem Scale; Perceived Stress Scale (PSS) and Stress Visual Analogue Scales (S-VAS) at baseline and after 28 days supplementation. Participants will complete the HADS and S-VAS at home on days 7, 14 and 21. On day 42 (14 days after treatment ending) participants will complete the GAD-7, HADS and S-VAS. 135 healthy women (who self-report being stressed and/or anxious) aged 18-26 (and born between 1997 and 2013) will be recruited using opportunity sampling. Participants will be supplied with either one of the active treatments or the placebo (allocated by a randomised schedule) whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study. Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, upon completion of the study. Read Less

The aim of this study is to evaluate the effect of an 8-week self-directed internet based CBT intervention on various psychological outcomes for young students struggling with procrastination in the UK. The psychological outcomes consist of motivation, depressive symptoms, impulsivity and anxiety. More specifically, the study aims to compare the effect of the intervention vs waitlist control at 8 weeks on primary and secondary outcomes. Additionally, the study aims to explore whether changes in primary and secondary outcomes as the result of the intervention are mediated or moderated by key intervention processes. Read Less

This prospective cohort study aims to assess the utility of a panel of molecular biomarkers for predicting the risk of relapse of Barrett's Oesophagus after endoscopic treatment of early oesophageal neoplasia with RadioFrequency Ablation (RFA). Patients who received endoscopic treatment of early oesophageal neoplasia with RFA and achieved endoscopic remission will be recruited. During the surveillance visits patients will receive a Cytosponge test followed by an endoscopy with Narrow Band Imaging (NBI) magnification and biopsies. Patients will receive an endoscopy every 6 months and Cytosponge every 12 months for at least 2 years. Molecular biomarkers including a methylation panel on DNA and immunohistochemical markers on formalin fixed paraffin embedded samples. After 2 years of intensive endoscopic follow up, patients will be prospectively tracked for up to 3 years. The investigators will also evaluate: * The risk of progression to dysplasia or oesophageal intestinal metaplasia (IM) in patients with IM at the GOJ post RFA in the absence of retreatment * the diagnostic accuracy of NBI for IM/dysplasia at the GOJ . Read Less

Gastric cancer has a very poor prognosis. The disease is often diagnosed at a late stage, when curative treatment options are limited or ineffective. There is a condition that predisposes to gastric cancer, known in medical terms as Gastric intestinal metaplasia (GIM). This pre-cancerous condition can be diagnosed with an endoscopic camera test, but it often very subtle and can be missed at routine endoscopy. There is evidence that about 7% of gastric cancers are missed at previous endoscopy. The Cytosponge-trefoil factor 3 (TFF-3) is a pill on a string combined to a molecular biomarker which could help early diagnosis of gastric cancer and GIM. Cytosponge-TFF3 has been showed in previous research to be useful to diagnose Barrett's oesophagus, a condition of the food pipe similar to GIM. The aim of this study is to investigate the utility of the Cytosponge in combination with molecular biomakers to diagnose GIM Read Less

70 patients with heart failure, AF and CRT with BiV\<95% will be randomised to either AF ablation or AV node ablation. Evaluation at 6 months with echocardiography and clinical assessment. Read Less

This project aims to study the immune responses to peanut allergen in those with a skin barrier defect with and without skin massage, specifically it aims to: 1. Establish if peanut allergen components can pass into human skin through regular massage using the peanut protein-containing extract. 2. Clarify whether this effect is amplified in those with an impaired skin barrier (AD and dry skin vs healthy controls). 3. Assess whether peanut protein components can be detected in interstitial skin fluid (ISF) using a suction device. 4. Test whether peanut protein components present in ISF are able to induce activation of basophils in blood of peanut allergic donors. 5. Assess whether the transcutaneous uptake of peanut protein can be reduced by the prior use of a barrier enhancing cream. Read Less

A Chronic Total Occlusion or CTO of a coronary artery is a an artery that has been blocked for \>/= 3 months. More than a decade ago, patients with such coronary artery blockage would have been sent for Coronary Artery Bypass Graft (CABG) surgery. Newer tools and techniques have facilitated the opening (angioplasty or percutaneous coronary intervention (PCI)) of such occluded arteries- however success is not 100% unlike in simple coronary blockages. Computed Tomography Coronary Angiography (CTCA) identifies the artery path and characteristics of the CTO including calcification - the latter many times is the reason for failure to cross the CTO. The investigators aim to conduct a feasibility study to assess the effectiveness of CTCA prior to CTO PCI by randomizing suitable CTO patients to CTCA or direct CTO PCI. 20 patients will be randomized 1:1 using the sealed envelope technique and compared for: Primary endpoint: CTO PCI success rate in CTCA arm versus no CTCA arm Secondary endpoints: i. Angina by the Seattle Angina Questionnaire (SAQ) at 6 months (range 0-100, lower score worse, higher scores better, based on 5 characteristics - severity, frequency, treatment satisfaction and quality of life scores). ii. Compare the number of patients who required a second CTO PCI procedure in the CTCA arm versus no CTCA arm iii. Procedural differences between the intervention CTCA arm versus no CTCA arm including: Health Economics: Cost saved per patient due to improved success and reduction in readmission or further procedure CTO PCI efficiency: Wire crossing time, Procedure time CTO PCI safety outcomes: Procedural complications (Ellis perforation, tamponade, acute kidney injury/contrast induced nephropathy, access site bleeding, donor vessel injury), Radiation: CTCA dose, CTO PCI dose, and combined CTCA and CTO PCI dose. Contrast: CTCA volume, CTO PCI volume, and combined CTCA and CTO PCI volume Change in CTO PCI strategy hierarchy as a result of the CTCA review Patients will have a telephonic follow up at 6 months to assess angina ( by the Seattle Angina Questionnaire) Read Less

This is a phase 2 study, designed as a European multicentre 6-month double blind random-ized controlled trial (RCT) of AZD0530 versus matched placebo, followed by a 12 month trial comparing open-label extended AZD0530 treatment with historical control data. Study population: Male and female adult patients aged 18 years and older with a diagnosis of FOP who meet the inclusion (active disease) and exclusion criteria will be eligible for participation in this study. The total number of enrolled patients will be 20. Intervention: Patients will be randomized to receive either AZD0530 100mg once daily or matched placebo, taken orally for the first 6 months, immediately followed by an open-label extension in which all patients will receive AZD0530 100mg once daily oral dose for a further 12 months. Endpoints: Endpoints include objective change in heterotopic bone volume measured by low-dose whole-body computer tomography (CT) , \[18F\] NaF Positron Emission Tomography (PET) activity and patient reported outcome measures. Read Less