Kilmarnock

This research aims to evaluate whether using the Both EARS BEARS training package alongside usual care for three months can improve hearing abilities in children and teenagers aged 8 to 16 with two cochlear implants. The study focuses on improving speech understanding in noisy environments, hearing experiences, vocabulary, quality of life, and reducing listening effort. The trial is conducted in clinical cochlear implant departments within National Health Service or University hospitals. Participants will be randomly assigned to one of two groups one group will use the BEARS training package, which includes virtual reality games targeting speech-in-noise perception, music listening, and sound localization, alongside their usual care. The other group will continue with usual care alone. The BEARS training is designed to be self-administered using either a head-mounted display or iPad with headphones, with a recommended minimum of two 30-minute sessions per week over three months. Participants will undergo hearing assessments and complete questionnaires before starting the intervention. They will be followed up for nine months after the three-month intervention period through online and in-person visits. The study measures include spatial speech-in-noise test results, vocabulary tests, fatigue scales, hearing quality questionnaires, and health economic outcomes. Participants and clinicians may also participate in interviews related to the study.

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.

Researchers are conducting Enroll-HD, a large, ongoing observational study that combines and expands previous Huntingtons disease HD registries across multiple continents, including Europe, North America, Australasia, and Latin America. This study collects longitudinal clinical data and biological samples from individuals with manifest HD, those carrying or at risk of carrying the HD gene mutation, and control participants without the mutation. The goal is to build a rich database to support research into disease progression, prognosis, and developing clinical trial endpoints. Participants include those with diagnosed HD, pre-manifest carriers, relatives with unknown or negative genotype status, family controls, and community controls. The study involves annual assessments with no planned end date, allowing for long-term data collection. Researchers collect demographic, clinical, family history, genetic, and blood sample information systematically from over 150 sites worldwide. During the study, participants undergo motor, functional, behavioral, and cognitive assessments using standardized tools such as the Unified Huntingtons Disease Rating Scale and Problem Behaviors Assessment-Short. Data are updated at each visit, including clinical signs and genotyping results. The study database is periodically made available to researchers globally, and participants may contribute for many years, helping to advance understanding and support future interventional studies in HD.

Researchers are evaluating the efficacy and safety of intravenously administered fosfomycin in treating severely infected patients across Europe. This prospective, multicenter, non-interventional study focuses on infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis or central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections covered by national guidelines. Patients receive fosfomycin intravenously according to the respective national Summary of Product Characteristics SmPC. The study is observational and does not involve randomization or placebo. It includes monitoring during treatment and follow-up periods, with evaluations up to six months for treatment outcomes and up to one year for osteomyelitis follow-up. The study documents clinical and microbiological cure rates, clinical improvements, and sodium and potassium serum levels during hospital stays. Participants are assessed for clinical success at multiple points, including initial response within 7 days, end of treatment up to 6 months, test of cure, and follow-up up to one year for osteomyelitis. Safety monitoring includes daily recording of adverse events, serious adverse events, adverse drug reactions, and deaths during treatment and follow-up. The study tracks dropouts due to treatment failure or adverse events. Overall, participation duration varies depending on treatment and follow-up schedules.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are studying breast cancer patients who have Triple Negative Breast Cancer TNBC andor a germline BRCA mutation gBRCA to see if adding olaparib, a PARP enzyme inhibitor, to platinum-based neoadjuvant chemotherapy is safe and improves the complete response rate at surgery. This is a randomized, open-label phase IIIII trial conducted in three stages, involving at least 780 patients, including 220 with gBRCA mutations. Participants receive at least 21 weeks of chemotherapy before surgery. Study groups include a control arm receiving paclitaxel and carboplatin, and two experimental arms where patients receive the same chemotherapy plus oral olaparib tablets taken twice daily during specified days of each 3-week cycle. Additional treatments such as prophylactic granulocyte-colony stimulating factor and anthracyclines are given as per local practice. Patients with residual disease after chemotherapy may join a sub-study with further treatments. During the trial, patients undergo screening tests including BRCA mutation testing, tumor marker assessments, and standard cancer staging. Researchers monitor treatment safety and effectiveness through pathological complete response rates, adverse events, survival outcomes, quality of life questionnaires, and imaging. Follow-up occurs for up to 10 years after surgery, with safety data regularly reviewed by independent committees to ensure participant well-being.

Aortic stenosis AS affects many older adults, with a rising number of people over 65 and 75 years old experiencing moderate to severe disease. This study aims to compare the benefits of early aortic valve replacement AVR versus expectant management in patients with severe asymptomatic AS. It addresses a significant gap, as no randomized controlled trials have yet compared these approaches to determine which leads to better outcomes and cost-effectiveness. Participants will be randomly assigned to either early AVR, where surgery or transcatheter AVR TAVI is planned within six months, or to expectant management, involving regular monitoring according to standard hospital practice. The study will be conducted across multiple centers in the UK, Australia, and New Zealand, with an internal pilot phase to confirm recruitment feasibility. Those in the AVR group may undergo additional tests such as coronary angiography, with further treatment decisions made by their care team. During the study, participants will be followed for a median of 5.5 years, with assessments including cardiovascular events, hospitalizations, quality of life questionnaires, and health economics evaluations. Researchers will measure a combined outcome of cardiovascular death, heart failure hospitalization, and stroke, along with other health and disability measures. The study will use intention-to-treat analysis, ensuring participants are evaluated in their assigned groups regardless of treatment received.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant ASCT. It is a phase III, randomized, controlled, multi-center, open-label study aiming to assess whether adding a proteasome inhibitor to salvage ASCT conditioning improves depth of response and how consolidation and maintenance therapy influence the durability of response. The study also evaluates overall survival, progression-free survival, response rates, minimal residual disease, toxicity, and quality of life. Participants first receive re-induction therapy with 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone ITD, each cycle lasting 28 days. Those achieving at least stable disease are randomly assigned to receive either conventional ASCT using melphalan alone or augmented ASCT combining melphalan with ixazomib. After ASCT, participants with minimal response or better are further randomized to either receive consolidation with 2 cycles of ITD followed by ixazomib maintenance until disease progression or no further treatment. During the study, participants undergo regular assessments including response evaluation 100 days post-ASCT, monitoring of progression-free survival for up to 120 months, and measurement of minimal residual disease at several time points. Safety and toxicity are closely monitored throughout re-induction, post-ASCT, consolidation, and maintenance phases. Quality of life questionnaires are completed at baseline, post-re-induction, post-ASCT, and during follow-up visits up to 24 months. The study plans to register 406 participants, with 284 randomized at the first stage and 248 at the second stage.