Kilmarnock

Researchers are investigating whether the BEARS training package, a virtual reality-based directional listening training, can improve speech-in-noise perception, hearing experiences, vocabulary, quality of life, and reduce listening effort in young people aged 8 to 16 years who have two cochlear implants. This trial focuses on children and teenagers with bilateral cochlear implants, as everyday communication can be challenging and tiring for them, especially in noisy environments. The study is conducted in National Health Service or University hospital cochlear implant departments. Participants will be randomly assigned to one of two groups: one group will use the BEARS training package alongside their usual care for three months, while the other group will continue with usual care alone. The BEARS package consists of three virtual reality games targeting speech-in-noise perception, music listening, and sound-source localization. Players are guided through tasks and receive feedback on their progress. It is recommended to use the BEARS training for at least one hour per week, split into two 30-minute sessions, playing all three games. Before starting the intervention, participants will complete hearing assessments and questionnaires. They will then be followed for a total of 12 months, including the 3-month intervention and a 9-month follow-up period with online and in-person appointments. The study will measure outcomes such as spatial speech-in-noise perception using the SSiN-VA test after three months. Researchers will also monitor hearing experiences, vocabulary, quality of life, and listening effort throughout the study. Optional interviews related to the BEARS program may also be conducted.

Researchers are evaluating two different early treatment methods for adults hospitalized with sepsis, a serious condition caused by the body's extreme response to infection. This study focuses on comparing starting a vasopressor medication called norepinephrine immediately versus the standard approach of first giving fluid through a drip and then adding vasopressors if needed. The goal is to see which method better improves recovery, reduces complications, shortens hospital stay, and enhances long-term health. This is a Phase 3 clinical trial addressing a critical and complex condition with significant risks to patients' organs and survival. The study compares early peripheral vasopressor infusion (PVI) started within 12 hours of hospital admission targeting a mean arterial pressure (MAP) of 65 mmHg or higher, against the usual care involving intravenous fluids followed by vasopressors as needed. Norepinephrine is prepared at a concentration of 16 micrograms/ml and administered either as an early continuous infusion or after fluid resuscitation. Balanced crystalloid fluids are given according to standard care practices. Current guidelines and clinical practices inform the treatment approach, but this study aims to clarify the benefits of early vasopressor use in septic shock. Participants will be monitored for clinical effectiveness during the first 48 hours, with follow-up extending to 90 days after randomization. The study includes assessments such as blood pressure, serum lactate levels, and clinical status evaluations. Researchers will track recovery times, complications, hospital length of stay, and long-term health outcomes. Safety monitoring and evaluation of adverse effects will be ongoing throughout the study period to ensure participant well-being.

Researchers are conducting Enroll-HD, a large, long-term observational study involving individuals affected by Huntington's Disease (HD), those at risk, and control participants. This study combines data from previous registries in Europe, North America, Australasia, and now includes Latin America. It aims to build a comprehensive database of clinical information and biological samples to support research on disease progression, prognosis, and clinical characteristics, as well as to establish clear endpoints for future interventional studies. Enroll-HD collects detailed clinical and genetic information along with blood samples from participants categorized as carriers of the HD gene mutation, controls without the mutation, and family or community controls. The study enrolls participants from over 150 sites in 23 countries and conducts annual assessments without a set end date. Participant groups include those with manifest HD symptoms, pre-manifest carriers, relatives with unknown genotype, and genotype-negative relatives. Participants undergo yearly evaluations including motor, functional, behavioral, and cognitive assessments using standardized scales such as the Unified Huntington's Disease Rating Scale and the Problem Behaviors Assessment-Short. Researchers track changes over an average of one year or longer through this ongoing registry. Data collected supports multiple research efforts and is accessible to qualified researchers worldwide.

This research focuses on evaluating the use of intravenously administered fosfomycin to treat severely infected patients across Europe. It includes those with serious infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis and central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections as permitted by national guidelines. The study is prospective, multicenter, non-interventional, and aims to document both the effectiveness and safety of this treatment. Patients receive fosfomycin treatment according to the national Summary of Product Characteristics (SmPC) guidelines for fosfomycin intravenous use. The study does not involve comparing treatment groups or altering standard care but observes patients receiving fosfomycin in routine clinical settings. There are no specific dosing schedules or additional interventions imposed by the study protocol. During the study, participants are monitored until the end of treatment, which may last up to six months after starting fosfomycin. Researchers evaluate clinical success by assessing whether patients achieve clinical cure or improvement. Safety and outcomes are recorded through clinical observations, with the goal of better understanding fosfomycin's role in treating severe infections.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

Researchers are investigating the safety and effectiveness of adding olaparib, a PARP enzyme inhibitor, to platinum-based chemotherapy given before surgery in patients with triple-negative breast cancer (TNBC) and/or those with germline BRCA (gBRCA) mutations. This randomized phase II/III trial aims to see if this combined treatment improves the rate of pathological complete response (pCR) at surgery while monitoring safety outcomes. The study plans to enroll at least 780 patients, including a minimum of 220 with gBRCA mutations. Participants will receive a minimum of 21 weeks of chemotherapy followed by surgery. The treatment includes oral olaparib tablets taken twice daily about 12 hours apart, alongside intravenous paclitaxel and carboplatin given in cycles every three weeks. During the trial, standard supportive care like granulocyte-colony stimulating factor and anthracyclines may also be administered. For those with residual disease after initial treatment, there is an option to join a sub-study involving additional chemotherapy drugs. Throughout the study, patients will undergo screenings including BRCA mutation testing and various tumor marker assessments. Safety will be closely monitored by the trial team and an independent committee. The main outcomes measured are treatment-related side effects, pCR rates after surgery, and long-term efficacy assessed over approximately 5.5 years, with follow-up planned for up to 10 years after surgery.

Aortic stenosis (AS) affects a significant portion of the elderly population, with approximately 5% of those over 65 years old and around 3% of those over 75 years having moderate to severe AS. The number of people with AS is increasing rapidly due to an aging population, creating challenges for clinicians in managing mostly elderly patients who are often symptom-free but have severe AS diagnosed incidentally. While symptomatic severe AS requires aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI), the best approach for asymptomatic patients remains unclear. This trial aims to compare early AVR or TAVI with standard expectant management in these patients to provide evidence on clinical outcomes and cost-effectiveness. The study is a large, multi-center randomized controlled trial conducted in the UK, Australia, and New Zealand, with plans to expand internationally. It includes two phases: a vanguard phase and a main phase, with an internal pilot to ensure adequate recruitment over two years. Eligible participants with severe asymptomatic AS will be randomly assigned to either early AVR or ongoing surveillance (expectant management). Those in the early AVR group will undergo surgery within about three months, which may include additional procedures like coronary angiography and possible coronary interventions if needed. The trial uses intention-to-treat analysis to compare outcomes between groups. Participants will be closely monitored throughout the study, with evaluations including routine tests and assessments as part of their care. The primary outcome measured is a combination of cardiovascular death and hospitalization for heart failure over a minimum of three years. The study also collaborates with another trial, EVoLVeD, offering participants additional research opportunities. Overall, the study seeks to provide important data on whether early valve replacement before symptoms develop can improve outcomes for people with severe asymptomatic AS.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant (ASCT). This phase III, open-label, randomized, controlled study aims to evaluate whether adding a proteasome inhibitor to the salvage ASCT conditioning improves the depth of response, and to assess the impact of consolidation and maintenance treatments on the durability of response. The study also looks at overall survival, progression time, quality of life, and treatment safety among participants with measurable disease and good performance status. All participants first receive re-induction therapy consisting of 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone (ITD) over 28-day cycles to achieve maximum disease control. Those who reach stable disease or better are randomized to receive either conventional ASCT using melphalan or augmented ASCT combining melphalan with ixazomib. Following this, participants who maintain minimal response or better undergo a second randomization to either receive consolidation therapy with 2 cycles of ITD followed by ixazomib maintenance until disease progression, or no further treatment. During the study, participants will undergo regular assessments including blood tests, disease response evaluations, and monitoring for adverse effects. The primary outcomes measured are overall response rate 100 days after ASCT and progression-free survival up to 10 years. Secondary evaluations include overall survival, time to disease progression, minimal residual disease status at various stages, engraftment kinetics, and quality of life. Follow-up continues with clinic visits every three months until disease progression is observed, enabling long-term monitoring of treatment effects and safety.