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NCT ID: NCT05565170 Active, not recruiting - Dementia Clinical Trials

Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults

LETHE
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

Previous research has shown that a healthy lifestyle, including a balanced diet, physical and social activity, and management of vascular risk factors can support both cardiovascular and brain health. In a landmark Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a multimodal lifestyle programme had clear benefits on older adults' cognition, functioning, and quality of life. The LETHE study utilises novel technologies and digital tools to deliver an optimised and more personalised FINGER-type multimodal lifestyle intervention. A total of 160 digitally skilled older adults (age 60-77) with risk factors for dementia but without substantial cognitive impairment will be recruited in Austria, Finland, Italy, and Sweden. Participants will be randomly assigned in a 1:1 ratio to the structured ICT-assisted multimodal lifestyle program (intervention group) or a self-guided lifestyle program (control group). Duration of the study and the intervention is 24 months. The multimodal lifestyle program covers the following domains: physical activity, nutrition, cognitive activity, vascular risk management, social interaction, sleep, and relaxation. The structured intervention program follows a hybrid model where regular in-person, individual and group-based intervention activities led by professionals are supported with activities in the LETHE mobile phone application. The self-guided (control) group receives relevant health advice and is recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine. Control group will have access to a simplified version of the LETHE app without any structured, scheduled activities or personalized content. The primary objective of the LETHE trial is to test the feasibility of a digitally supported multimodal lifestyle program (i.e., retention rate, adherence to intervention), and assess change in dementia risk based on validated risk scores (CAIDE, LIBRA). Other objectives include testing the intervention effects on lifestyle and risk factors, cognition, function, health-related quality of life, health literacy, physical functioning, and dementia-related biomarkers. To this aim, a range of personal, lifestyle, and health-related data will be collected both actively and passively with the help of digital devices. Attitudes towards digital tools and experiences of trial participation will also be explored.

NCT ID: NCT05526092 Active, not recruiting - Clinical trials for Overweight and Obesity

OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals

Start date: September 12, 2022
Phase: N/A
Study type: Interventional

The overall objective of this research entity is to reveal the holistic health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. This is achieved by investigation of the plasma lipids, plasma antioxidant status, fecal microbiota and fecal bile acids. Additionally the effect of the 6-week diet on posptprandial glycemia and postprandial satiety and vitality are investigated.

NCT ID: NCT05501873 Active, not recruiting - Atrial Fibrillation Clinical Trials

Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

FARADISE
Start date: March 24, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response. Boston Scientific has developed the FARAPULSEā„¢ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death. This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSEā„¢ pulsed field ablation System is used per hospitals' standard of care.

NCT ID: NCT05479721 Active, not recruiting - NAFLD Clinical Trials

LITMUS Imaging Study

Start date: September 4, 2019
Phase:
Study type: Observational

The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD). It aims to evaluate the diagnostic performance of imaging biomarkers (ultrasound elastography and magnetic resonance biomarkers) against NAFLD histological scores in a cross-sectional analysis and the natural history of NAFLD in a longitudinal study.

NCT ID: NCT05479383 Active, not recruiting - COVID-19 Clinical Trials

Tobacco Use and Uptake of COVID-19 Vaccinations

Start date: October 2, 2017
Phase:
Study type: Observational

This is an observational study of participants in two general population health surveys (FinSote 2018 and 2020) who are followed up for their COVID-19 vaccinations or end of follow-up. The primary objective is to examine the association between tobacco use and COVID-19 vaccine uptake and between-dose spacing.

NCT ID: NCT05477524 Active, not recruiting - Lyme Disease Clinical Trials

An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)

VALOR
Start date: August 4, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,000 healthy participants 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence. Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months later. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective. If enrolled, participants will need to visit the research site at least 7 times during the study. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years.

NCT ID: NCT05469360 Active, not recruiting - Alzheimer Disease Clinical Trials

Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants

Start date: February 23, 2023
Phase: Phase 1
Study type: Interventional

Phase 1b study to assess the pharmacodynamics, safety, tolerability, and pharmacokinetics of NIO752 in patients with early Alzheimer's disease (AD)

NCT ID: NCT05451680 Active, not recruiting - Skin Tumor Clinical Trials

Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.

NCT ID: NCT05446779 Active, not recruiting - Pheochromocytoma Clinical Trials

Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death

SuddenDeath
Start date: February 3, 2022
Phase:
Study type: Observational

Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.

NCT ID: NCT05426265 Active, not recruiting - Clinical trials for Major Depressive Disorder

The Effects of Videogames on Depression Symptoms and Brain Dynamics

Start date: June 28, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the effects of a game-based digital-therapeutics (DTx) medical software device on the symptoms of depression in adults with confirmed major depressive disorder.