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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: NCT06142071 Recruiting - Cancer Clinical Trials

Mixed Methods Study to Assess Family Members Unmet Needs in an Oncology Setting

SALUTE
Start date: January 8, 2024
Phase:
Study type: Observational

The main questions the study aims to answer are: 1. The proportion of family members of cancer patients who say they need more support 2. What support family members feel would be beneficial Information about patients' cancer diagnosis and treatment will be collected from their medical notes. Participating family members will be asked to complete a telephone questionnaire. Selected family members may also be asked to participate in an optional follow-up interview.

NCT ID: NCT06141512 Recruiting - General Health Clinical Trials

Improvements in Aerobic Fitness With Exercise Training: the Role of Myokines

Start date: October 23, 2023
Phase: N/A
Study type: Interventional

For both healthy adults and patients with cardiovascular disease (CVD), aerobic fitness (V̇O2max) is a stronger predictor of the risk of future chronic disease and premature death than other established risk factors such as hypertension, smoking, or Type 2 diabetes. It is important to improve the understanding of the regulation of V̇O2max to enable optimisation of interventions aimed at increasing V̇O2max in the current predominantly sedentary population. Currently, only exercise training is a viable method for increasing V̇O2max. However, ~10-20% of people who follow fully supervised, standardised training interventions do not demonstrate a measurable increase in V̇O2max. Low response to training is a clinically relevant concern, but the large variability in response to exercise training also provides an opportunity to dissect out the molecular mechanisms responsible for adaptations to V̇O2max by contrasting low vs. high responders to training. It has been previously demonstrated that low responders for VO2max fail to up regulate a number of genes that encode putative 'myokines', while the high responders demonstrated a significant increase in the expression of these genes, suggesting these myokines may play an important mechanistic role in modulating VO2max. The aim of the present study is to examine whether low responders for VO2max have an attenuated increase in the plasma levels of the previously identified myokines.

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: NCT06141057 Recruiting - Malaria Clinical Trials

A Study to Compare Two Dosing Regimens for a New Malaria Vaccine

Start date: June 6, 2023
Phase: Phase 1
Study type: Interventional

Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. Most of the deaths are in children under five living in Africa. It is a major problem for those who live in affected areas and for travellers. There is a great need for a safe, effective malaria vaccine. This study is being done to evaluate an experimental malaria vaccine for its safety and also look at the body's immune response to the vaccine. The vaccine tested in this study is called and "RH5.1". This is given with an adjuvant called "Matrix-M". This is a substance to improve the body's response to a vaccination. The aim is to use the vaccines and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will assess: 1. The safety of the vaccines in healthy participants. 2. The response of the human immune system to the vaccines. This will be achieved by giving participants three doses of the RH5.1 vaccines at two different dose levels (10 micrograms and 50 micrograms). One group will have 3 doses of 10 micrograms given at 0, 1 and 6 months whilst the other will receive 2 doses of 50 micrograms (at 1 and 2 months) followed by a 10 microgram dose at 6 months- known as a 'delayed fractional dose'. Blood tests and information about any symptoms will be performed/collected that occur after vaccination. Information from previous studies suggests that a delayed fractional dose improves the immune response to the vaccine, particularly in terms of the antibody response. Current prediction is that this improvement is due to the delay in dosing, rather than the reduction in dose, and this study will help to answer that. Having a vaccine at a single dose is important for efficient production and dosing for vaccines rolled out in national programs so being able to move away from 'delayed fractional dose' regimens to 'delayed final dose' regimens will be important for vaccine development.

NCT ID: NCT06140693 Recruiting - Health Behavior Clinical Trials

A Comparison of Affective Responses During Continuous and Interval Exercise

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

Regular exercise is important for good health, but many people do not achieve the minimum physical activity recommendations. How exercise makes people feel is an important factor in how much exercise people do. Affective valence (AV) is a measure of the pleasure and/or displeasure people feel. It has been suggested that if the drop in AV with exercise can be minimised, then people will be more likely to enjoy the exercise, and adhere to the exercise long-term. Much research has been done to elucidate the factors that affect changes in AV with exercise, with a focus on exercise intensity. It has been hypothesised that AV will increase with low to moderate exercise intensities, but will decrease with higher exercise intensities. This has led a number of researchers to claim that there is little value in research examining the health benefits of high-intensity interval training (HIIT) and/or sprint interval training (SIT), as the exercise intensities used in these exercise routines are so high that affective valence is expected to drop to levels that are suggested to be unpalatable to members of the general public. However, this hypothesis ignores the likely moderating effect of exercise duration: most available evidence indicates that affect drops over time with increasing exercise duration. This means that it is possible for a longer exercise bout at a lower intensity to be associated with a greater drop in AV compared to a shorter bout of exercise at a higher intensity. This may explain why recent studies have demonstrated that low-volume SIT protocols may be associated with a similar drop in AV compared to moderate-intensity continuous exercise, but are considered more enjoyable. It is hypothesised that exercise enjoyment (and subsequent uptake and adherence to an exercise routine) is linked to the amount of time spent at reduced AV, rather than the absolute drop in AV per se. To investigate this hypothesis, changes in affective valence will be measured in response to three bouts of moderate intensity continuous exercise at different intensities but equal duration (30 minutes) as well as two bouts of SIT involving different numbers of sprint repetitions and sprint duration but equal intensity. It will be determined whether exercise enjoyment is related to the time spent at reduced levels of AV. The overall aim of this study is to further elucidate the exercise protocol parameters that influence changes in AV with exercise.

NCT ID: NCT06140251 Recruiting - Heart Failure Clinical Trials

Investigation of Biomarker Response to SGLT2 Inhibition in Heart Failure

SiN-HF
Start date: August 21, 2023
Phase:
Study type: Observational

This is a 26-week, open label, single-arm prospective evaluation of the effects of sodium glucose cotransporter 2 (SGLT2) inhibition on cardiac biomarkers, myocardial remodeling and patient reported outcomes in heart failure with both impaired and preserved left ventricular fraction.

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.

NCT ID: NCT06137781 Recruiting - Surgery Clinical Trials

Digital Prehabilitation for Patients Undergoing Major Elective Surgery

Start date: February 19, 2024
Phase: N/A
Study type: Interventional

Prehabilitation describes the process of improving someone's functional capacity before major surgery. Prehabilitation commonly focuses on exercise training, as fitness level is a predictor of surgical outcomes - the fitter you are before surgery, the lower the risk of complications after surgery. Typically, exercise training is done at the hospital, but research shows that patients would prefer to do prehabilitation exercises in their home. The goal of this study is to test the feasibility of an online prehabilitation programme made by PreActiv, which can be accessed at home via a website by patients who are awaiting major surgery. PreActiv's prehabilitation programme is six weeks long, and involves three 35-minute exercise sessions per week, with each session including a warm-up, cardio exercises, muscle strengthening exercises, and breathing exercises. Information from this pilot study on the number of exercise sessions attended (adherence) and the number of patients who complete the study (retention) will be used to decide whether we should progress to a larger study that assesses the effectiveness of PreActiv's prehabilitation.