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NCT ID: NCT05971979 Recruiting - Sepsis Clinical Trials

Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

TDM-TIME
Start date: December 14, 2023
Phase:
Study type: Observational

Severe infections can be caused by various organisms, such as bacteria or viruses, and lead to otherwise healthy people getting very unwell, sometimes needing treatment in hospital or even intensive care. For the treatment of bacterial infections to be successful, the correct antibiotics need to be given promptly. Early in the course of illness, clinicians often do not know exactly which bacteria are causing the infection. Furthermore, patients differ in terms of how their bodies process the antibiotics they are given; this means that some may get too much and others too little. This can in turn lead to some patients not being fully cured, and others coming to harm due to side effects of higher doses of these drugs. For certain types of antibiotics, clinicians are able to measure their levels in the bloodstream, which can help guide dosing. This is called therapeutic drug monitoring, and is commonly used in clinical practice. One of the problems with therapeutic drug monitoring is that it is often not available outside of regular working hours, is costly, and most importantly, provides clinicians with useful information only after a few days of treatment have already been completed. This may be too late to treat these severely ill patients with life-threatening infections, where early and appropriate treatments matter. The aim of our study, called TDM-TIME, is to look at how long it takes for blood samples to get from the patient to the laboratory to be measured, with the results then communicated back to clinicians. We are further looking to investigate whether steps can be taken to improve these timings, which would lead to shorter times until treatments can be improved. As our study is observational, we will not change anything about the treatment of our patients, but will only be measuring levels of antibiotics in their blood.

NCT ID: NCT05971563 Active, not recruiting - Phenylketonurias Clinical Trials

Amino Acid Kinetics of GMP-AA in Healthy Human Volunteers

Start date: October 18, 2022
Phase: N/A
Study type: Interventional

Children with phenylketonuria (PKU) are treated with a special diet supplemented with a synthetic protein based on amino acids. These have a poor taste and are inefficiently used by the body. A different type of synthetic protein, called glycomacropeptide is being tried in PKU. It tastes better than amino acids but it requires the addition of some extra amino acids which may worsen how well it is absorbed compared with traditional amino acid supplements. We will perform a 3-part trial in healthy adult volunteers to compare amino acids vs glycomacropeptide protein with a 'normal protein' (casein) to examine the absorption properties of these proteins. Volunteers will take one dose of each of the protein sources on 3 different days. Blood and urine samples will be collected examining the rate of absorption of amino acids over 5 hours on each study day.

NCT ID: NCT05971407 Recruiting - Hypertension Clinical Trials

The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults

RIPCo
Start date: September 25, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether remote ischaemic conditioning, applied chronically, improves vascular health in older adults

NCT ID: NCT05971277 Recruiting - Advanced Cancer Clinical Trials

Home And Locally Observed - Tracking (HALO-Trak)

HALO-Trak
Start date: January 30, 2023
Phase:
Study type: Observational

The goal of this observational study is to collect biometric, HRQoL, immune response and genomic data continuously and intermittently during and after chemo or immunotherapy for the generation of a complex dataset using a platform which can aggregate different types of data collected over a time period and, to test the potential for analysis within and across data sets with linkage to clinical outcomes. The framework will have capabilities to integrate data from electronic medical records (EMRs) such as Epic, as well as digital streams including sensor, genomic, imaging and pathology. Such a platform can realise the potential for machine learning (ML) methodologies to address important cancer outcomes.

NCT ID: NCT05971212 Recruiting - Sleep Hygiene Clinical Trials

Sleep Support for Children With Neurodevelopmental Disorders

Start date: January 29, 2021
Phase: N/A
Study type: Interventional

Around 80% of children with neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are reported to have significant difficulties with sleep. This may be a problem with settling off to sleep, waking repeatedly in the night, or both. Often these children will be prescribed a medication called melatonin to help them sleep, but there is no strong evidence of its effectiveness in children, the long-term side effects are not known and prescriptions for this drug cost millions of pounds a year for the NHS. Many children continue to have persistent sleep problems despite taking melatonin. Sleep support programmes delivered by nurses and sleep practitioners are known to be effective and to give parents and young people long-term strategies for promoting sleep without the use of medication. However, sleep support services are not universally funded. In this feasibility study 76 children with ADHD, autism or other neurodevelopmental disorder who have been prescribed and have been regularly taking melatonin for at least a year but still have severe sleep difficulties will be recruited. The investigators will help to improve the child's sleep with a sleep practitioner support programme and, if possible, reduce the dose of melatonin or stop it completely if it is no longer needed. Using this design, it will be possible to test whether a programme delivered by sleep practitioners will significantly improve sleep for children using a non-medical approach and in turn improve the health and well-being of the child and family and reduce melatonin prescribing, thereby saving NHS resources and the potential for long-term side effects. The study design will be delivered by Sheffield Children's Hospital and supported by parent users, the Sleep Charity and Sheffield CCG. The results will be disseminated widely to local, regional and national groups as well as via social media.

NCT ID: NCT05971108 Recruiting - Clinical trials for Hepatocellular Carcinoma

Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC

REVISE-HCC
Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (HCC) which implies significant mortality. At present current surveillance methods detect hepatocellular carcinomas at a late stage resulting in few treatment options for patients and, in the majority of cases, premature death. The goal of this study is to implement Elecsys® GAAD in real-world hepatocellular carcinoma surveillance for those with liver cirrhosis. The main questions it aims to answer are: - Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway increase early detection of HCC? - Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway reduce false positive tests and unnecessary confirmatory investigations? - Does the new surveillance pathway improve adherence? Researchers will compare Elecsys® GAAD with standard of care tests to see if it results in earlier detection of hepatocellular carcinoma and will explore potential improvements to the surveillance pathway.

NCT ID: NCT05970484 Recruiting - Clinical trials for Alcohol Use Disorder

Supporting Women in the UK Armed Forces Who Consume Alcohol at an Increased Risk: Refining the DrinksRation Platform

RationW
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Alcohol misuse is common in the Armed Forces (AF), with prevalence higher than in the general population. To date, initiatives to support alcohol misuse have focused on males, who represent ~90% of the AF. However, female veterans drink disproportionally more than female members of the public. In this study, the investigators will refine and evaluate DrinksRation - the only automated brief digital intervention supporting the United Kingdom (UK) Armed Forces to manage and reduce the amount they drink - to tailor the intervention to the specific needs of female veterans. The changes will then be assessed using a confirmatory Randomized Controlled Trial (RCT), which includes a minimum of 148 (74 in each arm) female veterans (to be recruited).

NCT ID: NCT05970172 Recruiting - Clinical trials for Chronic Kidney Disease

A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease

Start date: January 16, 2024
Phase: Phase 3
Study type: Interventional

Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells. Current treatment for anemia is to have injections of medicines called erythropoietin stimulating agents (also known as ESAs) to help the bone marrow make more red blood cells. These are often given together with iron. This treatment is also available to children and teenagers with CKD. However, there are some safety concerns with ESAs. Also, as roxadustat is taken orally, this may be another option for treating anemia in children and teenagers with CKD. In this study, children and teenagers with CKD and anemia will take roxadustat for up to 52 weeks to treat their anemia. The main aim of the study is to learn how roxadustat affects anemia in children and teenagers with CKD. This is an open-label study which means the children and teenagers in the study and the clinic staff know they will be taking roxadustat. In this study, the children and teenagers with CKD who need treatment for anemia can take part. Those currently being treated with an ESA will be switched to roxadustat. Those who have not been treated with an ESA can start on roxadustat straight away. All children and teenagers in the study will take roxadustat 3 times a week for up to 52 weeks (1 year). They will start on a fixed dose of roxadustat for 4 weeks. Blood samples will be taken regularly to check hemoglobin levels. The roxadustat dose may be changed if the blood levels of hemoglobin are too high, too low, or change too quickly. After 4 weeks the dose may be changed, if needed, to keep blood levels of hemoglobin in the blood to just below the normal range. Firstly, teenagers will take roxadustat. 10 teenagers will take their fixed dose of roxadustat for 4 weeks. They will give blood samples to help the researchers work out the most suitable dose for the rest of the teenagers in the study. When the rest of the teenagers start taking roxadustat at the most suitable dose for teenagers, 10 children will take roxadustat for 4 weeks. These 10 children will give blood samples to help the researchers work out the most suitable dose for the rest of the children in the study. Then, the rest of the children will take roxadustat at the most suitable dose for children. There will be many clinic visits during the study. Overnight hospital stays are not expected. There will be 1 visit every 2 weeks for the first 4 weeks of taking roxadustat, then every 4 weeks until the end of treatment. Finally there is 1 visit 4 weeks after treatment has finished. During most visits, the children and teenagers will have their vital signs checked (blood pressure, body temperature and heart rate). Fluid status (how much water is in the body) will also be checked for those who need dialysis. The children and teenagers will also have blood tests and the study doctors will check for any medical problems. The children and teenagers will have a medical examination before their first dose of roxadustat and again at about 24-week (6-month) and 52-week (13-month) visits. They will have an electrocardiogram (ECG) before their first dose of roxadustat and again at the 12-week, 24-week, 36-week, and 52-week visit. They will also have urine tests at the 4-week, 24-week and 52-week visits. At the 52-week visit, the children and teenagers will also have blood tests for hemoglobin and iron levels. The study doctors will also check for any medical problems.

NCT ID: NCT05968547 Not yet recruiting - Glaucoma Clinical Trials

Evaluation of Patients' Requirements for Improved Advice and Guidance on Vision Standards for Driving in Glaucoma

D&G
Start date: August 25, 2023
Phase:
Study type: Observational

Glaucoma can affect both central and peripheral vision. Clinicians need to discuss with patients the vision related driving standards and any specific limitations their patients may have relating to their ability to drive with glaucoma. According to the recent guidelines by the General Optical Council (GOC), clinicians are advised to make sure that the Driving and Vehicle Licensing Agency (DVLA) is informed about patients who do not meet the driving vision standards. There are several limitations in making a professional judgement about a patient's suitability to drive and in providing appropriate advice to patients. The main concern is discussing this sensitive issue with the patient based upon available clinical evidence e.g. vision or visual field and directing them to inform the DVLA of their condition or potentially advising them to stop driving. The purpose of this research is to investigate the two main issues 1. To explore patients' understanding of standards of vision for driving. 2. Comparing the standards of vision for driving estimated in the clinic with number plate vision. We propose to do a mixed methods analysis using a patient survey and quantitative investigation of driving vision standards.

NCT ID: NCT05968521 Recruiting - Heart Failure Clinical Trials

Cardiac Rehabilitation for Young People

CardioActive
Start date: March 4, 2024
Phase: N/A
Study type: Interventional

Heart problems are amongst the most common physical illnesses in children and young people (CYP). They can be present from birth or develop as CYP get older and are linked to increased physical and psychological difficulties overprotection from caregivers and healthcare providers and reduced quality of life. While adults are offered exercise classes and lifestyle advice after a heart problem, CYP with heart problems are not. Improving health behaviours in people with heart problems is vital, improves quality of life and reduces additional illnesses (i.e obesity, diabetes). Approximately 1 in 3 CYP with heart problems have anxiety and/or depression so it is also important to support their mental health. One way to do this is to develop and test the acceptability and feasibility of a trial of cardiac rehabilitation (CR) consisting of exercise with mental health support for CYP. The aim is to develop and test the feasibility and acceptability of a trial of a cardiac rehabilitation programme for CYP.