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Researchers are evaluating two different pacing methods for patients with slow heart rates, called bradycardia. This study compares the common right ventricular pacing approach with a newer physiological pacing method that includes His bundle and left bundle area pacing. The trial aims to better understand how these pacing techniques affect patient outcomes, including mortality and heart failure morbidity, in a large group of 2600 patients. Participants will receive a pacemaker implant and be randomly assigned to either right ventricular pacing or physiological pacing. The physiological pacing may involve His bundle pacing or left bundle pacing, but if these are not successful, biventricular pacing will be used. A subgroup of 500 participants will take part in an optional echocardiographic sub-study to assess heart function changes over a 24-month period. Throughout the study, patients will be assessed at baseline and every six months after randomization, with follow-up lasting up to 78 months. Researchers will monitor outcomes such as mortality, heart failure events, device-related safety issues, patient quality of life, symptoms, and pacemaker-derived data like arrhythmias and activity levels. The echocardiographic sub-study will measure specific heart function changes to understand pacing-induced cardiomyopathy. Participants involvement includes implantation, regular follow-up visits, questionnaires, and optional imaging assessments.

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

Researchers are studying the effects of CYB003, a deuterated psilocin analog, compared to a matching placebo as an additional treatment for adults with Major Depressive Disorder MDD. This Phase III study aims to evaluate the safety, tolerability, and effectiveness of two different doses of CYB003 alongside participants current antidepressant medications and psychological support. Participants will be randomly assigned to one of three groups one receiving 8 mg of CYB003, another receiving 16 mg of CYB003, or a placebo group. Each participant will undergo two dosing sessions about three weeks apart while continuing their usual antidepressant treatment and receiving manualized psychological support from a facilitator. Non-responders in the placebo group may have the chance to receive CYB003 in an extension trial. During the study, participants will complete several assessments including the Montgomery-Asberg Depression Scale MADRS, Beck Depression Inventory-II BDI-II, Clinical Global Impression Scale CGI-S, Generalized Anxiety Disorder 7-Item Scale GAD-7, and Quality of Life Enjoyment and Satisfaction Questionnaire Q-LES-Q-SF. These evaluations occur at multiple timepoints from screening through the end of the trial. Safety and tolerability will be closely monitored throughout the study, with the total duration lasting approximately 12 weeks from baseline to study end.

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

Researchers are comparing the effectiveness of two different combinations of immunotherapy drugs with chemotherapy for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has PD-L1 expression of 1% or higher. This phase 3, randomized study focuses on participants who have not previously received systemic treatment for advanced disease. The goal is to determine which combination better improves overall survival and other outcomes in this patient group. Participants will be randomly assigned to receive either Nivolumab plus Relatlimab combined with chemotherapy or Pembrolizumab combined with chemotherapy. The chemotherapy drugs used include Carboplatin, Pemetrexed, or Cisplatin, given in specified doses on scheduled days. Treatment is given as first-line therapy for their cancer, with dosing details managed throughout the study period. During the study, participants will undergo imaging scans like CT or MRI to measure disease status, and blood tests to monitor safety and side effects. The main outcome measured is overall survival over up to five years, along with progression-free survival, response rates, duration of response, and adverse events. Researchers will also assess symptoms related to lung cancer over two years. Participants are monitored regularly to track these outcomes and ensure safety throughout the study duration, which may last several years.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the effects of teplizumab compared with placebo in children and young adults aged 1 to 25 years with recently diagnosed Stage 3 type 1 diabetes. The study aims to measure changes in blood sugar control and independence from mealtime insulin over 52 weeks while participants continue standard insulin therapy. Participants will be randomly assigned to receive either increasing doses of teplizumab or a matching placebo, both given by intravenous IV infusion. The treatment period lasts 52 weeks, during which participants receive the study drug or placebo by IV infusion. The total study duration for each participant is approximately 84 weeks 19 months, including treatment and follow-up. Throughout the study, participants will undergo regular assessments including blood tests measuring glycated hemoglobin HbA1c, C-peptide levels from meal tolerance tests, and continuous glucose monitoring to track blood sugar levels. Researchers will also monitor insulin use, adverse events, drug concentrations in the blood, and antibody responses. Safety and efficacy are evaluated up to 78 weeks, with multiple visits scheduled across the study period.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Researchers are evaluating the effects of black rice consumption on cognitive function, inflammation, and vascular health in older adults aged 50 to 80 years. The study focuses on understanding whether anthocyanin-rich black rice can improve memory and cognitive abilities, reduce inflammation, and support vascular function, as these factors tend to decline with age and may be linked to increased inflammatory markers found in older populations. This is a randomized controlled crossover study where participants consume either black rice or brown rice meals. The study measures acute effects 2 hours after eating the rice and short-term effects after 7 days of daily consumption. Participants attend four study visits, during which blood samples are taken to assess inflammatory markers, and cognitive tests are conducted using computer-based platforms. Vascular function is evaluated through laser Doppler imaging, blood pressure, and heart rate measurements. Participants will undergo a screening visit including health assessments and initial cognitive tests. During study visits, participants fast for 8 hours before consuming test meals and then complete cognitive and vascular assessments at baseline and after 2 hours. For the short-term phase, participants consume rice daily at home for 7 days and keep a compliance checklist. The primary outcomes include various cognitive tests, while secondary outcomes track inflammation and vascular markers. Data privacy and safety are maintained throughout, with a total study duration of about two weeks per participant.

Obsessive-Compulsive Disorder OCD is a common and often disabling condition in young people, marked by distressing and repetitive thoughts and behaviors. This research aims to explore the delivery of a brief cognitive behavioral therapy CBT for adolescents aged 11 to 18 years with OCD within routine NHS child and adolescent mental health services CAMHS. The study focuses on whether this brief CBT approach is feasible, acceptable, and effective, including for young people with co-occurring autism or high autistic traits. The intervention involves five core face-to-face CBT sessions lasting 60 to 90 minutes each, with an option for two additional booster sessions over 24 weeks. These sessions are delivered by trained clinicians in NHS settings and supported by co-designed workbooks completed by the young person between sessions. Parents or carers also receive a workbook to support the young persons progress. Sessions start weekly and become less frequent over time, focusing on understanding OCD, goal setting, cognitive flexibility, and behavioral experiments. Involvement of parents and other adults is encouraged to help apply learning in daily life. Participants will engage in assessments at baseline, post-treatment 12 weeks, and 3-month follow-up 24 weeks, including interviews, questionnaires, and routine clinical measures of OCD symptoms, anxiety, and depression. Clinician adherence and treatment acceptability will be monitored through session attendance, engagement, and feedback from young people, parentscarers, and clinicians. Qualitative interviews will assess experiences, and data will be analyzed to explore changes in symptoms and treatment processes, including for those with autism. The study runs from May 2025 to March 2026 with 20 to 30 young people and 8 to 10 clinicians involved.

Sepsis is a serious condition caused by the bodys extreme response to an infection, leading to tissue and organ damage. This research compares two early treatment methods for sepsis immediately after hospital arrival, focusing on whether starting vasopressor medication right away or beginning with fluid therapy improves patient recovery and reduces complications. The study is a Phase 3 trial aimed at finding the best approach to improve outcomes for adults with septic shock. Participants are divided into two groups one receives a continuous peripheral vasopressor infusion of norepinephrine during the first 48 hours, while the other group receives standard care guided by UK NICE and Surviving Sepsis Campaign guidelines, which starts with intravenous fluids and adds vasopressors as needed. Both treatments follow local hospital protocols beyond the initial interventions. During the study, participants will be closely monitored for blood pressure, fluid volume, lactate levels, and other health indicators at multiple time points up to 90 days after randomization. Researchers will assess outcomes including hospital stay length, need for additional therapies like renal replacement or respiratory support, and overall survival. Quality of life and readmission rates will also be evaluated to understand the longer-term effects of the treatments.