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NCT ID: NCT06071650 Recruiting - Cancer Clinical Trials

Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers

Start date: February 27, 2023
Phase: N/A
Study type: Interventional

Prehabilitation is the use of exercise prior to surgery to improve peoples' fitness, which leads to improved outcomes of surgery. This service is now being run remotely, however, there is little existing evidence to support the best practice for this. Currently, baseline fitness is assessed remotely using either a sit to stand test or a step test. Once completed people are prescribed regular exercises and asked to exercise to a level of intensity using a measure called Rating of Perceived Exertion (RPE). However, these measurements may not be reliable. We are carrying out a study to assess if another waking test (modified Rockport test) and asking patients to exercise to a target heart rate are better measures of assessing baseline fitness and exercise intensity. All participants will receive weekly telephone calls to check their progress and be provided with a wrist worn fitness tracker (Fitbit). Participants will be randomised to one of two groups. The only difference between the groups will be the way the exercise is prescribed. In one group participants will be asked to complete the exercises to an exercise level they find "somewhat hard". The other group will be asked to complete the exercises to maintain a set heart rate. All participants will be asked to complete an activity log (submitted weekly) as an online form. A small group of people (maximum 10) will be asked if they would like to complete an in-person baseline fitness assessment also, this is optional. This study runs for up to eight weeks with participation ending after eight weeks or at the time of surgery, whichever is sooner. In the final week of participation, participants will be asked to complete an online questionnaire about their experience of using a wearable fitness tracker during the prehabilitation programme.

NCT ID: NCT06070662 Recruiting - Clinical trials for Microvascular Angina

Non-invasive Diagnosis of Coronary Microvascular Disease: Pilot Study

Start date: November 1, 2023
Phase:
Study type: Observational

- 40% of patients presenting with stable chest pain (angina) have no significant blockage of the main heart arteries. Identifying why these patients have symptoms will mean better treatment options can be developed. - About 60% of these patients have evidence of coronary microvascular disease (CMD). In this condition there is a problem with the heart's microvessels (very small blood vessels that branch from the main heart arteries). Due to problems with these vessels there is a mismatch between the blood supply to the heart and its oxygen consumption, causing chest pain and this can also lead to major heart events. - At present, to diagnose this condition, specialised techniques during an invasive test, called a coronary angiogram, are required. As this is an invasive test, it can be lead to complications and cause discomfort. - Non-invasive ways of diagnosing CMD are required to improve the diagnosis and management of this condition. - This study aims to provide initial data on whether novel imaging techniques using CT and MRI scans, which are much less invasive, could identify CMD. - To do this, patients with suspected angina referred for angiography and who are already participants in the main research study 'CMR versus CT-FFR in CAD' study will be recruited. - These will be patients with suspected CMD and also those with blockage of the main heart arteries (triple vessel disease) to compare against. - Participants in this pilot study will have additional tests used to diagnose CMD during their invasive angiography procedure. Participants will then have an MRI scan involving novel techniques and exercise MRI, where individuals exercise use a cycle or stepping machine during the MRI scan. Further analysis will also be undertaken of CT images acquired as part of the main study. - These tests will be compared against invasive test results to see which show potential in being able to diagnose CMD.

NCT ID: NCT06068855 Recruiting - Clinical trials for Masseter Muscle Prominence

A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants

Start date: October 17, 2023
Phase: Phase 3
Study type: Interventional

The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominice (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP. BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is 1 in 4 chance that participants will be assigned to placebo. Around 248 adult participants with MMP will be enrolled in the study at approximately 30 sites in Europe. Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to the masseter on Day 1. Participants who are eligible for retreatment will be given BOTOX on Day 180 and will be followed for up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT06068842 Recruiting - Clinical trials for Non Small Cell Lung Cancer

A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants With Non-Small Cell Lung Cancer

METRIX
Start date: November 3, 2023
Phase:
Study type: Observational

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases of which 60% are non-squamous (NSQ). This study will evaluate the prevalence of mesenchymal epithelial transition (MET) overexpression (OE) in adult participants with advanced or metastatic NSQ NSCLC. Archived tissue biopsies will be tested for MET OE and data from approximately 500 participants will be collected. No participants will be enrolled in this study. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 15 months. There is no additional burden for participants in this trial.

NCT ID: NCT06068803 Recruiting - Aging Clinical Trials

Do Ketone Drinks Improve Immune, Metabolic and Cognitive Health in Older Adults

Start date: September 14, 2023
Phase: N/A
Study type: Interventional

The goal of this randomised, double-blinded, placebo-controlled trial is to investigate the immune, metabolic and cognitive effects of four weeks of daily ketone supplementation in adults aged 60 to 80 with stable health. The main objectives are to assess the effects of the intervention versus placebo on markers of metabolic health, inflammation, immune function, adipose tissue, and cognitive performance. Participants will undergo two weeks of baseline monitoring followed by a four-week supplementation period in which they will drink a ketone monoester drink or taste-matched placebo three times a day. During these periods, participants will record their diet and supplement intake and their physical activity and blood glucose will be monitored using wearable devices. At the beginning and end of the supplementation period, participants will undergo testing in the university physiology laboratories, involving blood, expired air and adipose tissue samples, as well as cognitive tests, physical tests and questionnaires.

NCT ID: NCT06067828 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).

ATHLOS
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.

NCT ID: NCT06067750 Recruiting - Clinical trials for Traumatic Brain Injury

Comparison of Narcotrend and Cerebral Function Analysing Monitor in Intensive Care to Monitor Seizures and Deep Sedation

Start date: June 27, 2023
Phase:
Study type: Observational

A study in the use of the Narcotrend depth of anaesthesia monitor to record a) seizures, and b) monitor a level of sedation referred to as 'burst suppression', in sedated patients in the adult and paediatric intensive care. Studies have shown that patients in coma on the intensive care unit may have subclinical in addition to clinical seizures. Subclinical seizures are seizures that do not show any outward signs and may go undetected. The current gold standard of recording seizures in the intensive care unit is by non-invasive, continuous monitoring of the electrical activity of the brain by electroencephalography (cEEG) using cerebral function analysing monitor (CFAM). This is recorded with simultaneous video recording and is performed by Clinical Neurophysiology departments. There has been a steady increase in demand for this service over recent years. Additionally, CFAM / cEEG is labour intensive and expensive. If trends continue, the proportion of hospitals offering CFAM / cEEG will continue to rise, creating increased demand for specialist staff, of which there are a finite number. Depth of anaesthesia monitors are used by anaesthetists to assess the level of anaesthesia in sedated patients using specialised, automated EEG analysis and are now recommended by NICE (DG6) to tailor anaesthetic dose to individual patients. This study aims to investigate the utility of the Narcotrend depth of anaesthesia monitor to monitor for seizures and burst suppression on the adult and paediatric intensive care unit. These monitors are cheaper and more widely available with the scope to be used at every bed space requiring neuro observation on the intensive care unit. The study aims to recruit all patients who are referred for CFAM / cEEG monitoring at Nottingham University Hospitals (NUH) Trust over a 12 month period. These patients will undergo simultaneous recording using CFAM / cEEG and depth of anaesthesia monitoring.

NCT ID: NCT06067477 Recruiting - Clinical trials for Vitamin D Deficiency

Estimation of the Dietary Requirement for Vitamin D in Ethnic Groups

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

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.

NCT ID: NCT06067230 Recruiting - Clinical trials for Respiratory Syncytial Virus

A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults

Start date: October 6, 2023
Phase: Phase 3
Study type: Interventional

The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).

NCT ID: NCT06066658 Recruiting - COPD Clinical Trials

Anxiety Management in Breathlessness.

Start date: October 2023
Phase: N/A
Study type: Interventional

The goal of this mixed methods study is to learn about cranial electrotherapy stimulation (CES) using Alpha-Stim AID in anxiety related to breathlessness in advanced lung diseases. The main question[s] it aims to answer are: - Is CES using Alpha-Stim AID acceptable and tolerable as a potential treatment in the management of anxiety in patients who experience breathlessness due to advanced chronic respiratory disease? - What are the key factors that will inform the design of a study to examine its potential clinical effectiveness? Participants will choose whether they want to trial the CES for eight weeks or be in a parallel control group. They will complete daily diaries, questionnaires about anxiety, breathlessness, sleep, quality of life and depression, and an end of study qualitative interview. Researchers will compare those using the CES and those receiving standard care to see if there are any indications of difference in anxiety and other symptoms experienced.