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NCT ID: NCT06143046 Recruiting - Clinical trials for Respiratory Syncytial Virus

A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers

Start date: November 15, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.

NCT ID: NCT06142942 Recruiting - Clinical trials for Cardiorespiratory Fitness

Effect of Sprint Interval Training Frequency on Improvements in Fitness

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

The goal of this study is to learn how the number of weekly exercise sessions affects improvements in fitness in healthy university aged students. The main question it aims to answer is how training frequency affects improvements in fitness. Participants will complete a pre-testing sessions to assess fitness level and sprint performance. Following this participants are assigned to one of four groups. A group that exercises 2 days a week, a group that trains 3 days a week, a group that trains 4 days a week, or a no-exercise control group. Participants in this group will not complete any training and allow the researchers to compare the exercise groups to a group that didn't train. Each participant will train for 4 weeks. During each training session participants will complete 4-6 30 second all-out sprints with 4 minutes of rest between each. Participants will complete the same tests they did during the pre-testing session following the 4 weeks of training to see how frequency affects improvements.

NCT ID: NCT06142890 Recruiting - Aging Clinical Trials

Efficacy of Ceiling Fans for Mitigating Thermal Strain During Bed Rest in Older Adults During Heat Waves

Start date: December 5, 2023
Phase: N/A
Study type: Interventional

With the increasing regularity and intensity of hot weather and heat waves, there is an urgent need to develop heat-alleviation strategies able to provide targeted protection for heat-vulnerable older adults. While air-conditioning provides the most effective protection from extreme heat, it is inaccessible for many individuals. Air-conditioning is also energy intensive, which can strain the electrical grid and, depending on the source of electricity generation, contribute to green house gas emissions. For these reasons, recent guidance has recommended the use of electric fans as a sustainable cooling alternative. While fans may increase sweat evaporation and heat loss in healthy, young adults, evidence supporting their use in older adults is scarce. Further, studies show that when environmental temperature exceeds skin temperature, fans are not effective and can even exacerbate hyperthermia in older adults. While older adults only account for ~13% of the population, they account for ~40% off all hospitalizations. In the context of sustainable cooling interventions, this is of particular importance given that many hospitals and long-term care homes do not have air-conditioning and rely on ceiling fans to enhance sweat evaporation while participants are bed-resting. While recent biophysical modelling has suggested that pedestal fans likely provide a clinically meaningful cooling effect (proposed to be ≥0.3°C) in temperatures below ~34°C in older adults, the efficacy of ceiling fans in mitigating heat strain in these conditions is currently unknown. To address these knowledge gaps, this randomized crossover trial will evaluate body core temperature, cardiovascular strain, orthostatic intolerance, dehydration, and thermal comfort in adults aged 65-85 years exposed for 8-hours to conditions experienced during indoor overheating occurring during a heat wave in a temperate continental climate (31°C, 45% relative humidity). Each participant will complete two randomized exposures that will differ only in the airflow generated by a ceiling fan: no airflow (control) or standard airflow. Participants will remain in a supine position for the duration of the 8-hour exposure period, except for during hour 7 when they will complete a series of cardiovascular autonomic response tests.

NCT ID: NCT06142773 Recruiting - Clinical trials for Ventilation Therapy; Complications

Study to Investigate an Association Between Brain Activity and Tidal Volume in Humans (BATMAN)

BATMAN
Start date: November 30, 2023
Phase: N/A
Study type: Interventional

The communication between the lungs and the brain has drawn a lot of attention recently. Animal studies have shown that the breathing cycle is coupled with brain activity, showing that the greater the volume of air delivered to the lungs via a breathing machine greater the brain activity and also the greater the injury to the brain cells. There is no study in humans that investigates the physiological communication between the volume of air delivered to the lungs and brain activity. This is important because really sick patients receive breathing assistance using breathing machines to keep their oxygen levels within a normal range. Although these machines are life-saving tools, they might result in brain cell injury, leading to cognitive impairment. So, establishing the existence of a physiological communication between the volume of air delivered using these breathing machines and brain activity is the first step to investigating therapies to prevent brain cell injury due to the use of breathing machines to assist breathing.

NCT ID: NCT06141733 Recruiting - Death Clinical Trials

2 Year Follow up of COSGOD III

COSGODIII-FU
Start date: January 1, 2024
Phase:
Study type: Observational

The COSGOD III trial performed follow up until term age or discharge from the neonatal intensive care unit, whatever came first. The first neonate was randomised in September 2017 and the last in October 2021. A prospective follow up of the included neonates until an age of two years was not feasible in the COSGOD III trial since funding for long-term follow-up was not available. However, data on long-term outcome of the included neonates into COSGOD III trial are of high interest. In many centres, who participated in the COSGOD III trial neonates are assessed routinely for long term outcome in outpatient clinics with Bayleys III/IV test or PARCA-R (Parent Report of Children's Abilities) questionnaire. Aim of the present study is therefore to analyse in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed long-term survival and neurodevelopmental outcome assessment at a corrected age of 2 years (18-30 months).

NCT ID: NCT06141642 Recruiting - Aging Clinical Trials

Self-Adaptive Immersive Virtual Reality Serious Game to Enhance Motor Skill Learning and Attention in Older Adults

SAVinGs
Start date: January 9, 2024
Phase: N/A
Study type: Interventional

While scientific evidence emphasizes the detrimental effect of sedentary behavior on health, the literature suggests that, on average, older adults spend 75% of their days in a sedentary manner, and often isolated (Petrusevski 2020). This lack of physical activity and social interaction not only leads to an increase in functional limitations and the risk of worsening an existing chronic disease but also elevates the risk of mortality. Furthermore, older adults face progressive functional decline, both in motor and cognitive aspects, as a result of aging, contributing to inactivity and sedentary behavior (Botö 2021). The literature suggests that new technologies such as immersive virtual reality (iVR) and serious games serve as effective means to promote active leisure, thereby breaking isolation and reducing sedentary behavior. The development of these new technologies is also promising for objectively and quantitatively measuring motor and cognitive activity (e.g., kinematics, reaction time). Serious games are defined as games whose primary objective is more focused on learning than entertainment. For instance, they allow the integration of physical and cognitive activity programs into a playful activity, conducive to long-term adherence. Their effectiveness is starting to be studied in hospitalized older adults (Cuevas-Lara 2021), especially as they also help combat age-related functional decline. Indeed, they provide the opportunity to promote and measure activity through enjoyable and self-administered exercises. However, despite the growing interest in serious games, the impact of self-adaptive serious games, compared to traditional (non-adaptive) serious games, on motor skill learning and attention function in older adults remains unclear. This gap in knowledge necessitates a rigorous investigation. Therefore, this randomized controlled trial seeks to address this gap and achieve the following objectives: 1. Compare the effect of a self-adaptive serious game to a non-adaptive serious game on motor skill learning and attention in older adults. 2. Enhance the understanding of how motor skill learning in immersive virtual reality translates to older adults' activities of daily living.

NCT ID: NCT06141486 Recruiting - Multiple Sclerosis Clinical Trials

Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Start date: December 27, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration ranging from approximately 27 to 51 months. - The study intervention duration will vary ranging from approximately 27 to 51 months. - The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.

NCT ID: NCT06141473 Recruiting - Multiple Sclerosis Clinical Trials

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Start date: December 13, 2023
Phase: Phase 3
Study type: Interventional

The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. - The study intervention duration will vary ranging from approximately 20 to 40 months. - The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.

NCT ID: NCT06140836 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).

NCT ID: NCT06139328 Recruiting - Clinical trials for Myocardial Infarction

IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack

IRI-EXPLORE
Start date: November 24, 2023
Phase: Phase 2
Study type: Interventional

This study is open to adults aged 18 and over who have just had a heart attack. The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack. Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 4 times as likely to receive BI 765845 than placebo. Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.