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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.

NCT ID: NCT06137144 Recruiting - Lymphoma Clinical Trials

AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.

PRIMAVERA
Start date: January 23, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

NCT ID: NCT06137118 Recruiting - Clinical trials for B-cell Acute Lymphoblastic Leukemia (B-ALL)

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Start date: December 29, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

NCT ID: NCT06136754 Completed - Tooth Erosion Clinical Trials

Investigate a Varnish to Protect From Erosive Toothwear

Start date: April 8, 2022
Phase: Phase 3
Study type: Interventional

This in-situ study will investigate on extracted teeth the protection of a re-formulated varnish containing fluoride in the same concentration as an existing approved varnish used to treat caries and erosion. Healthy volunteers without caries, periodontal disease or signs of erosive tooth wear and who give consent will be recruited to a cross-over blinded intervention. Custom mouthguards (splints) housing 8 sections of extracted human teeth will wear the appliance for 3 consecutive days and then repeat the study. Extracted teeth will be collected from patients needing tooth extraction for dental reasons. Their participation ceases when they donate the teeth. The teeth will be sterilised with hypochlorite for a minimum of 24 hrs and then sectioned and polished to form a 5mm x 5mm area of enamel and placed in the splint. The varnish, with and without fluoride, will be applied to the surface of the extracted teeth, allowed to dry, and then placed into the mouth of the healthy volunteers for 6 hours, after which, the varnish will be carefully removed. Overnight the splint and teeth will be kept in a clean and moist environment and replaced in the mouth the following day, again for 6 hours. Every 90 minutes, four times over the day, the splint will be removed and immersed in 1% citric acid pH 2.7 for 2 minutes. At the end of the day, 2 sections will be removed and tested in the laboratory for hardness. The splint will be reinserted in the mouth again for 6 hours during which it will be immersed in the acid again every 90 mins. At the end of the day the samples will be removed and measured using profilometry. A few weeks later the process will be repeated with either the fluoride or non-fluoride varnish, the order being randomly determined.

NCT ID: NCT06136650 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Start date: December 18, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.