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NCT ID: NCT06147323 Recruiting - Pre-diabetes Clinical Trials

Impact of High Fiber and Vegetal Protein Diet on Gut Health and Immunity Biomarkers in Prediabetic Patients

PreVegDiet
Start date: November 13, 2023
Phase: N/A
Study type: Interventional

The research area that focuses on the links between nutrition and health, nutrition and the immune system as well as nutrition-related public health interventions, which often falls into the gap between the agricultural and health domains. The rationale of this project is to study the influence of beneficial diets on the immune system of pre-diabetic patients and its potential to counteract infections. A clinical, an in vitro (cell systems) and an in vivo (animal model) approach will be used to study the influence of a seaweed bioactive supplement and a diet rich in components from a Mediterranean diet on a Salmonella typhimurium infection in prediabetic subjects. At the end of this project, we will provide evidence on the potential of these nutritional interventions to counteract infection, which are of high relevance to the society to reduce the burden of type 2 diabetes (T2DM) and obesity. This research is part of an ongoing research project funded by the Research State Agency (Spain), Health Research Board (HRB, Ireland) and the Medical Research Council (MRC-UKRI, UK) via the NUTRIMMUNE' Grant of the Joint Programming Initiative a Healthy Diet for a Healthy Life (JPI-HDHL).

NCT ID: NCT06146647 Recruiting - Body Image Clinical Trials

The Evaluation of Two Positive Body Image Micro-interventions for Children Aged 4-6 Years

Start date: November 3, 2023
Phase: N/A
Study type: Interventional

The goal of this 4-arm randomized controlled trial is to test the effectiveness of two positive body image media micro interventions (a tv show and a music video) in improving body image related constructs. The main questions this study aims to answer are: 1. Relative to time-matched active controls, are the two positive body image media micro-interventions effective in yielding immediate improvements in children's body functionality appreciation and body appreciation and in reducing anti-fat attitudes? 2. Are the two positive body image media micro-interventions acceptable to children and their participating parent/guardian? An additional five secondary exploratory research questions are described below [in the description section]. Participants will be recruited into the trial by a research agency via their parents/guardians. Once recruited, they will be randomised into one of 4 conditions: - 15-minute TV intervention - 15-minute active TV control - 3-minute music video intervention - 3-minute active music video control Children (and their parent or guardian) will visit a testing centre in groups of approximately 12 dyads. Children will complete T1 assessment interviews one-on-one with a researcher, before watching their assigned media with their parent. After watching their assigned media, children will complete their T2 assessment, again one-to-one with a researcher, while parents complete a survey regarding their acceptability of the media they watched. Parents/guardians will be given a link to rewatch their assigned media and encouraged to rewatch with their child before returning to the testing centre approximately one week later. When children and parents/guardians return one week later, the child will complete T3 assessment interviews one-to-one with a researcher, and parents will complete a short survey regarding their rewatch habits. Researchers will compare the two positive body image media micro-interventions with their time-matched active controls to examine if they are effective in yielding immediate improvements in children's body functionality appreciation and body appreciation and in reducing anti-fat attitudes.

NCT ID: NCT06146530 Recruiting - Treatment Adherence Clinical Trials

Cerina-A Pilot Randomized Controlled Trial

Cerina
Start date: April 24, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot Randomized Controlled Trial is twofold: 1) To learn about the feasibility and usefulness of a mobile application for generalised anxiety symptoms (Cerina); 2) To test the preliminary effects of Cerina in reducing generalized anxiety symptoms compared to a waitlist-control group among Ulster University students presenting mild to moderate symptoms of Generalized Anxiety Disorder (GAD) symptoms. The main research questions are: Is the Cerina app usable and feasible among Ulster University students reporting mild to moderate GAD symptoms? Is there an indication of the effectiveness of the Cerina app in reducing GAD symptoms compared to a wait-list control group among Ulster University students? - After the baseline assessment, eligible and consenting participants will be randomized to either intervention or to the wait-list control group. - Those who are allocated to the intervention group will have access to the Cerina app for 6 weeks. - Those who are in the wait-list control group will wait for 6 weeks until the intervention group finishes the intervention for their access. - The wait-list control group will have access to the services offered by the Ulster University Student Wellbeing team. - Participants in both groups will do mid- (at week 3 after their randomization) and post-assessment (At week 6 after their randomization). - All participants will also be invited to the post-assessment feedback interviews once they complete their post-assessments. The purpose is to have more in-depth information on their views of the Cerina app, the User Interface, the clinical content, the potential facilitators, and barriers to using it in daily life.

NCT ID: NCT06145971 Recruiting - Insomnia Clinical Trials

Assessing the Impact of Brief CBTi on Dissociative Seizures: SCED

CBTi 4 DS:SCED
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

Some people experience a temporary change in behaviour and consciousness, that often involves a collapse and/or shaking limb movements. These are referred to as 'Dissociative seizures'. Those who experience such seizures have been found to also display high levels of dissociation, which can be described as a change in your conscious experience and may include gaps in your memory for events. It is thought that people who experience dissociative seizures also often have difficulties with their sleep. Having difficulties with sleep may make these seizures and the amount of dissociation an individual experiences worse. Greater dissociation may be additionally linked to worsening dissociative seizures. A psychological treatment for sleep difficulties called Cognitive Behavioural Therapy for Insomnia (CBTi), has been found to be effective in reducing sleep difficulties. The main questions this study aims to answer are: 1. Does brief CBTi (bCBTi) improve sleep difficulties in those with dissociative seizures? 2. Does bCBTi reduce the frequency of dissociative seizures? 3. Does bCBTi reduce self-reported levels of dissociation in participants? 4. Does improving sleep difficulties lead to improvements in quality of life, mood and anxiety levels? 5. Is bCBTi a feasible intervention to administer in an inpatient setting? This study will investigate whether improving sleep by administering a brief version of CBTi leads to an improvement in levels of dissociation and dissociative seizure frequency. It will also investigate whether brief CBTi is a feasible treatment method for sleep difficulties in an inpatient setting. Participants who have dissociative seizures and sleep difficulties that could be diagnosed as insomnia will be randomly assigned to a baseline phase of 5, 7 or 9 days, where they will fill out daily questionnaires on their sleep, dissociation and number of seizures. They will then begin a 10-day intervention phase where they will attend two sessions of brief CBTi, whilst also completing daily measures. This will allow us to see whether their scores on the sleep and dissociation measures improve when the intervention begins. Participants will be asked to wear an Actiwatch during the night, to gather information on their movement levels during the night. Information on changes in quality of life, mood and anxiety levels following the sleep intervention will also be collected.

NCT ID: NCT06145880 Recruiting - Clinical trials for Pulmonary Hypertension

ADOPT: Improving Diagnosis of Pulmonary Hypertension With AI and Echo

ADOPT
Start date: December 1, 2023
Phase:
Study type: Observational

Pulmonary Hypertension (PH) is a condition caused by high blood pressure in the blood vessels that carry blood to the lungs. It can cause severe breathlessness and failure of the right side of the heart. Sadly it is often fatal, and life expectancy ranges from months to years. For some subtypes of PH, effective treatments exist which can improve life expectancy and quality-of-life. Accurate tools for the assessment of PH are therefore essential so that life-saving medications can be started earlier. In existing diagnostic pathways, evidence for the suspicion of PH is frequently overlooked, significantly delaying the time to diagnosis. Echocardiography (echo) is a quick, safe and well-tolerated test requested to investigate breathless patients, and which can provide useful information about the suspicion of PH. However, outside of specialist PH centres, doctors may not routinely look for and comment on the presence of clues to possible PH. The investigators think that using Artificial Intelligence (AI) techniques to read echo's could make their interpretation faster and more reliable. There may also be subtle clues to the presence or severity of PH on echo, less recognisable to the human eye, which AI can identify. In this study the investigators will gather echo images from 5 specialist PH hospitals across the UK which have all been anonymised (patient's name and personal details removed). These will all be historic scans (i.e. have already taken place) and will be grouped into those with PH present (including PH sub-type) or absent. These anonymised echo images will be used to develop and train an AI tool to identify scans where PH is present, including which specific type of PH may be present. The developed AI tool will then be tested on a separate group of scans (not used in the training stage) to validate its performance.

NCT ID: NCT06145867 Enrolling by invitation - Clinical trials for Chronic Fatigue Syndrome

A Feasibility Study: Assessing Photobiomodulation in Myalgic Encephalomyelitis

LightMEup
Start date: April 24, 2024
Phase: N/A
Study type: Interventional

There is no cure or approved treatments for ME. Several causes have been implicated in ME, including poor mitochondrial function. Mitochondria are the powerhouse of cells, producing energy. Therefore, loss of mitochondrial function and reduced energy production could be an explanation for the debilitating chronic fatigue that defines ME. The primary site of red light absorption in cells is the mitochondria. Mitochondrial red light absorption can boost energy production. Light therapy is already FDA approved for the treatment of acne, muscle and joint pain, arthritis, blood circulation issues and hair loss. This is the first study to trial the use of red light therapy in ME and results will help us understand if the use of red light therapy is accepted by ME patients. In past clinical trials the monitoring of symptom reduction/increase in ME patients was mainly done using symptom questionnaires. These questionnaires have not been specifically developed for ME symptoms and therefore the reliability of results is poor. This study will be assessing the use of a new symptom questionnaire developed specifically for ME and will also be trialling the use of other tools to measure symptom reduction/increase. In addition, this study will also trial the use of Mantal, an online remote research management portal. This is to improve accessibility of ME patients to research participation. Each ME participants involvement in the study should take approximately 7 weeks. Involvement is split into four phases: 1) baseline, 2) intervention, 3) follow-up and 4) feedback. Baseline assessments: - Week one: complete a 27-item questionnaire on functional capacity (FUNCAP27) and online cognitive function tests - Week two: participants are posted an activity monitor which they are to wear for seven days. Participants will complete a sleep diary (consensus sleep diary version E) for seven days Intervention: - Participants are posted the red lamp to use in their own homes during weeks three and four. Participants use the red lamp for two minutes, daily, each morning for a total of 14 days. Follow-up: - Weeks five and six - Repeating the baseline assessments Feedback: - Participants are asked to complete an online questionnaire during week seven.

NCT ID: NCT06145178 Recruiting - Clinical trials for Cytomegalovirus Infections

A Study of Human Cytomegalovirus (HCMV) Vaccine SPYVLP01 With and Without Adjuvants

SPYVAC01
Start date: November 22, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of the study is to evaluate the safety and immunogenicity of SPYVLP01 in two different doses with and without adjuvants in healthy adults aged 18-50 years old.

NCT ID: NCT06145087 Recruiting - Healthy Aging Clinical Trials

Effects of a Supplement to Target Ageing Mechanisms on Vascular Function (STAMINA)

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

In the ageing society, extending the healthy lifespan is a major challenge and a healthy diet may play an import role in maintaining health throughout life. With increasing age cardiovascular function declines and large and small blood vessels change in various and complex ways and these changes may lead to many age-related diseases. On a molecular level, there are many mechanisms that are associated with ageing including cellular senescence, loss of proteostasis, altered cellular communication, genomic instability, epigenetic alterations, telomere shortening, deregulated nutrient sensing, stem cell exhaustion and protein crosslinking. Animal and human studies suggest that dietary supplements may be able to affect these mechanisms. What the effect of the NOVOS Core supplement is on cardiovascular functions is not known. The aim of the present study is to investigate the short and intermediate term effects of a supplement mix designed to target ageing mechanism on vascular function in healthy middle-aged subjects. (STAMINA Study) The hypothesis is that the supplement will lead to acute and sustained changes in biomarkers of vascular function and health. 60 healthy middle-aged people will be recruited and randomly assigned to either daily intake of the NOVOS Core supplement (n=30) or placebo (n=30) for up to 6 months (3-6). The supplement (NOVOS Core) is a commercially available product and has 12 ingredients. It was developed and is provided together with the placebo by AgeLess Sciences LLC, a Public Benefit Corporation. The study will require 2 visits by participants during which non-invasive vascular exams will be performed, venous blood taken and spot urine sample collected. The primary endpoint is change in flow-mediated dilation, secondary endpoints are change in blood pressure, cholesterol, arterial stiffness, microvascular function cardiovascular risk SCORE and daily walking distance. Tertiary endpoints are changes in biomarkers of ageing as assessed in blood samples including DNA damage. In addition, we will assess anxiety, depressive feelings, happiness, well-being and the diet with several questionnaires. Measurements will be taken on the first day before and 2 hours after ingestion of the first supplement or placebo. Participants will consume the supplement or placebo for 6 months and vascular exams and one blood draw will be repeated during the final visit. During the time, participants will receive 2 phone calls to improve compliance.

NCT ID: NCT06144840 Recruiting - Clinical trials for Erythropoietic Protoporphyria (EPP)

INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP

INSPIRE
Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.

NCT ID: NCT06144684 Recruiting - Healthy Volunteers Clinical Trials

A First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295

Start date: November 29, 2023
Phase: Phase 1
Study type: Interventional

This is a single center, double-blind, randomized, placebo-controlled, single ascending subcutaneous dose study in lean to overweight or obese but otherwise healthy men. It is planned to enroll 4 cohorts of 8 subjects (Regimens A, B, C and D), with 2 additional optional cohorts of 8 subjects (Regimens E and F). Within each cohort, subjects will be randomized in a ratio of 6 active to 2 placebo. The primary objective is to assess the safety. Secondary objectives are to characterize the pharmacokinetics (PK) and to investigate pharmacodynamic effects.