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NCT ID: NCT06069427 Active, not recruiting - Clinical trials for Mental Health Wellness 1

The Effect of Reducing Total Volume of Sprint Exercise on Circulating Levels of BDNF

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

Regular exercise is well known to be required for good physical health, but exercise can also improve mental health. Although the effects of exercise on mental health have been shown in many studies, it remains unclear how exercise improves mental health. In recent years, the potential role of a specific protein called 'brain-derived neurotrophic factor' (BDNF) has received increasing attention. Higher levels of BDNF in the blood are associated with better cognitive performance, attention, and spatial memory. Conversely, low levels of BDNF in the blood are found in patients with depression, dementia, mild cognitive impairment, and Alzheimer's disease. BDNF can be released during exercise, with greater increases after exercise performed at higher intensities. For example, classic sprint interval training (SIT), which involves four 30-second 'all-out' cycle sprints, has been shown to lead to greater increases in BDNF compared to moderate or vigorous exercise. Although these results suggest that SIT is an effective way to increase BDNF, SIT is not generally considered feasible for patients or untrained members of the general public, because it is a very tiring type of exercise. However, other more manageable protocols have been developed, such as the 'reduced-exertion, high-intensity interval training' (REHIT) protocol, which involves two 20-second 'all-out' sprints within a 10-minute low-intensity exercise session. Although it is clear that BDNF levels increase in an intensity-dependent manner in response to exercise, the effect of exercise volume remains unknown. Exercise intensity is identical for SIT and REHIT, but if BDNF levels increase to a similar extent in response to both protocols, REHIT would constitute a more feasible intervention for use in patients and the general public. The aim of the present study is to compare the effects of REHIT vs. classic SIT on levels of BDNF in the blood. For this,15 study participants will be recruited, who will each complete a SIT session, a REHIT session, and a no-exercise control session. Levels of BDNF will be measured in blood samples taken at rest, as well as directly after exercise, 30 minutes after exercise, and 90 minutes after exercise. It will be determined whether the greater amount of sprint exercise in a SIT session will be associated with a greater increase in levels of BDNF in the blood compared to the REHIT session which consists of a lower amount of sprint exercise.

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: NCT06068452 Completed - Pancreas Cancer Clinical Trials

Role of Pre-operative CPET in Pancreatoduodenectomy

WHIPPLES
Start date: March 24, 2021
Phase:
Study type: Observational

A clinical database has been prospectively maintained by the investigators, with details of pancreatic resections since January 2016. It includes pre-operative details, details of multidisciplinary team (MDT) meeting, details of pre-operative biliary stenting, intra-operative details, post-operative morbidity and mortality, details of histopathological diagnosis, recurrence and survival. Data was collected onto the database (excel sheet) from trust data software, clinic letters, Somerset Cancer registry and clinical portal.

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: NCT06067321 Not yet recruiting - Anesthesia Clinical Trials

Gastric Residual Volumes in Infants Fed at 4 and 6 Hours Prior to General Anaesthesia

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The safety implications of prolonged fasting in young children prior to general anaesthesia are well described. Current UK guidance recommends a fasting time of 6 hours for formula milk prior to general anaesthesia. European guidance published in 2022 recommended a reduced fast of 4 hours for infants taking formula milk, albeit with a downgraded level 2B of evidence given the paucity of high quality research in this area. Although pulmonary aspiration of gastric contents under anaesthesia in children is a rare event, animal studies suggest that aspiration of particulate matter at volumes greater than 0.8 ml/kg gastric volume are associated with demonstrable lung injury and mortality. Although rate of gastric emptying of formula preparations has been extensively studied in neonatal intensive care settings for preterm babies using ultrasound, few studies have measured gastric volume directly in healthy term infants undergoing anaesthesia.

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).