All Clinical Trials in United Kingdom

In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population. Read Less

An aspect of IBD care that is often overlooked is mental health treatment. Common mental health problems, such as anxiety and depression are very common in IBD, with a meta-analysis estimating prevalence as high as 25.2% for depression and 32.1% for anxiety. The prevalence of anxiety and depression increases when individuals with active disease are considered, with rates as high as 57.6% for anxiety and 38.9% for depression. Comorbid depression and anxiety in IBD is associated with greater symptom severity, even when statistically controlling for disease activity; more frequent and expensive emergency department visits and inpatient stays, higher costs relating to IBD-related surgery, medication and personal expenditure; noncompliance with medical treatment and finally, increased likelihood of experiencing flares. However, very few studies attempt to unpick the precise mechanism of these bidirectional relationships. Indeed, depression and anxiety may have direct effects on physical health through inflammatory or psychoneuroimmunological pathways. Very few studies investigate the longitudinal brain-gut relationship with regards to objective measures of inflammation. Additionally, the indirect effects of mental health are often overlooked. Depression and anxiety are routinely associated with health behaviours, such as diet, physical activity, sleep, and tobacco/alcohol use.These health behaviours are important factors, given their impact on physical health outcomes. Therefore, a thorough investigation is required to ascertain the precise mechanisms that underpin the bidirectional relationship between depression/anxiety and inflammation/physical health, as this will enable practitioners and researchers to establish non-invasive, behavioural treatment targets for this patient group. AIM The broad aim of this project is to explore whether anxiety/depression has a direct or indirect (via health behaviours) on i) inflammation levels ii) clinical activity and iii) healthcare usage at follow-up, in a population of IBD patients. A secondary aim of the project will be to explore whether changes in disease activity, as measured by self-report measures and faecal calprotectin, explains changes in anxiety and depression symptoms at follow up. Read Less

This study aims to understand how vitamin D (VD) affects human health. Typically, prisoners are low on vitamin D, as it is difficult to receive through diet, and is mostly obtained via exposure to the sun. The investigators predict that VD supplements could help improve overall mental well-being, as well as improve bone health. The investigators aim to recruit two groups of participants from a United Kingdom (UK) Prison, all of whom will participate via an informed consent process. The first group of prisoners will have chosen to take VD supplements, the second group will have chosen not to take VD supplements. At the start of the study, prisoners will have their bone density and blood VD levels tested. The investigators will also ask participants to complete a series of questionnaires to understand the state of mental well-being at the start of the study. Participants will be asked to complete a food diary to track dietary intake over the following week. Additionally, the investigators are interested in identifying what proportion of participants have a specific genetic makeup relating to their ability to metabolise VD, and participants will be asked to provide a saliva sample to test this. Every month following the start of the study, participants will be asked to complete the same questionnaires and food diary again. On the 3rd month, the investigators will again test the participants' bone density and blood levels of VD, to see whether supplementation has improved participant VD status. This study will run for a minimum of 3 months, up to a maximum of 6. Read Less

The study plans to monitor around 300 people from different hospitals with COPD for a period of 3 months after they are discharged from the hospital using a smartphone app and a Fitbit device. This device can passively track certain health metrics; this way the research team can research whether it is possible to identify the early warning signs of a decline in health by using these ongoing measurements of vital signs and symptoms. This could allow doctors to intervene early and potentially prevent further deterioration in health decline and hospital admission altogether. The study seeks to investigate how similar these physiological measurements are when collected in the real world rather than just in the hospital setting, and what influence environmental factors have on a patient's health and experience of their condition. Read Less

This is a randomised double-blind placebo-controlled trial of L-serine in Hereditary Sensory Neuropathy type 1 (HSN1) due to variants in SPTLC1/2 gene. This is a single-centre study being conducted at the National Hospital for Neurology and Neurosurgery, London UK. The SENSE trial will test whether L-serine is an effective drug treatment to slow or stop disease progression in HSN1 due to variants in the SPLTLC1 or SPTLC2 gene. The other aim is to assess if Magnetic Resonance Imaging (MRI) can accurately detect the changes which occur in the muscles of people who have HSN1. Read Less

The goal of this randomized, double-blind, placebo-controlled, cross-over trial is to investigate the effects of beetroot-derived betalains on cardiovascular health, sleep and quality of life in healthy middle-aged individuals. The main question\[s\] it aims to answer are: * Do betalains improve vascular function? * Do betalains improve sleep? * Do betalains improve quality of life? Participants will be involved with the following: * Consuming a daily betalain-rich or placebo capsule for a month * Non-invasive cardiovascular measurements * Wearing a fitness tracker for tracking physical activity and sleep * Answering questionnaires regarding quality of life Researchers will compare results between the intervention versus the placebo group to see if any of the study outcomes are significantly different. Read Less

Sickle cell disease (SCD) is a genetic blood condition causing long term health problems including pain and brain problems which affect quality of life. These may be made worse if patients have low night-time oxygen levels when the upper airways close repeatedly during the night (obstructive sleep apnoea). This is associated with increased pain, poorer concentration and increased kidney problems. Montelukast, widely used in the treatment of Asthma, has been shown to improve symptoms of obstructive sleep apnoea in patients without sickle cell anaemia. Investigators think this treatment could be useful in patients with sickle cell disease too. Early intervention with Montelukast could help prevent deterioration in concentration and thinking skills. The aim of this trial is to see whether young children with sickle cell disease randomised (randomise: the same as tossing a coin and not knowing whether it will come up heads or tails) to Montelukast treatment have better thinking skills compared with people randomised to placebo (tablet with no active medical ingredients - i.e. "sugar pill"). This means that the child could be on Montelukast treatment or he/she might be on placebo tablets. Read Less

The goal of this "digital health intervention" study is to test a novel email management tool called "AirEmail" (version 1, or v1) for its impact on improving key aspects of healthcare email management. The main questions it aims to answer are: * What are the effects of technostress in staff employed by the National Health Service (NHS)? * Can the AirEmail digital tool improve email productivity? * Can the AirEmail digital tool improve participant digital wellbeing? Participants will use AirEmail for a period of 4 weeks as part of their routine management of healthcare email. This active use period will be preceded and followed by 2 weeks of an "observational mode" in which email use data is collected. Researchers will compare participants in the active study group with participants in the contemporary observational group to see if the volume and patterns of email communications have been affected by external factors or AirEmail use. Read Less

The goal of this multicentre mixed -methods study is to understand the patient and clinician perspective on the ideal timing of an operation for Crohn's disease of the terminal ileum (last part of the small bowel). The main questions it aims to answer are: * What factors influence patients' and clinicians' preferences with regards to the timing of the first bowel resection for isolated Crohn's disease of the terminal ileum? * What are patients' and clinicians' views on 'early' bowel resection (as an alternative to medical therapy) in this context? * What are the facilitators and barriers to implementation of early surgery in practice? Participants will be patients with Crohn's disease of the terminal ileum and healthcare professionals involved in treating inflammatory bowel disease. Healthcare professionals have previously been asked to participate in an interview to understand their views on the role of surgery for Crohn's disease of the terminal ileum. They will now be invited to participate in a choice exercise to understand how much weight they attribute to various factors and outcomes when choosing between surgery and medication for Crohn's disease of the terminal ileum. Patients will be asked to participate in: 1. an interview about their treatment choices 2. a choice exercise to understand how much weight they attribute to various factors and outcomes when choosing between surgery and medication for Crohn's disease of the terminal ileum 3. a survey, for patients with a previous ileocaecal resection, assessing their experience of the operation Read Less

Parkinson's disease is a progressive neurological condition which affects more than 145,000 people in the United Kingdom (UK) today. The main symptoms are tremor (uncontrolled shaking), slowness of movement and difficulty starting movements (termed 'freezing'). Daily exercise is recommended to help with these symptoms. Rehabilitation can help to maintain a person's balance, ability to walk and help to prevent falls. This can allow people living with Parkinson's to maintain their independence for longer. Rehabilitation is usually carried out at face-to-face appointments in outpatient departments in hospitals. STROLLL (www.strolll.co) is a company that have created a programme of activities called Cue X, to be used on augmented reality glasses. Augmented reality glasses merge computer generated images and sounds with the real world. Cue X has been created specifically to help people with Parkinson's. We are aiming to recruit 50 participants through referrals from specialist doctors, nurses and physiotherapists in Leeds Teaching Hospitals National Health Service (NHS) Trust. We will ask these health care professionals to give potential participants an information sheet outlining the project. A more detailed participant information sheet will be sent by post or email to those interested. There will be an initial hospital appointment where written consent will be asked for and an initial assessment completed. Participants will do a personalised, daily rehabilitation programme using Cue X on augmented reality glasses for 6 weeks at home (monitored remotely by a physiotherapist). A final assessment and review will be done in hospital. The purpose of this project is to see if people with Parkinson's can use the glasses and do exercises in their own homes. Benefits could include fewer trips to the hospital for appointments and a more engaging way of participating in rehabilitation. If successful, this could lead further research into this technology as a new way of delivering rehabilitation. Read Less

Heart failure represents a growing public health problem within the UK and particularly within the North West of England. A major challenge is that heart failure is currently diagnosed too late. The researchers have previously developed a risk calculator that accurately identifies individuals at risk of heart failure admission or death before they have developed heart failure. Most risk calculators are never implemented into clinical practice. The researchers will l perform a pilot study to evaluate the risk calculator within primary care in Greater Manchester. Read Less

Presence of Patent Ductus Arteriosus is detrimental to an infant born prematurely. The primary objective is to study the efficacy of Paracetamol (proposed new treatment) in treating haemodynamic significant Patent Ductus Arteriosus (hsPDA) in comparison to Ibuprofen (current standard treatment) in preterm infants. Outcome of such treatment will check on the conversion of hsPDA to non-hsPDA. All preterm infants (born at \<32 weeks gestational age or birth weight \< 1500 grams) with haemodynamically significant patent ductus arteriosus (hsPDA) who are ≤ 28 days old will be included over 2 years. Sample size 32. Secondary outcomes of this study will compare 1) BPD (broncho-pulmonary dysplasia) free survival at 36 weeks post menstrual age (PMA), 2) incidence of complications of prematurity in each group and 3) to record any evidence of adverse effects with Paracetamol or Ibuprofen. Read Less