Airdrie

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the safety and effectiveness of two different drug combinations for people with relapsed or refractory multiple myeloma RRMM who have had between one and three prior treatments and prior exposure to lenalidomide. The trial compares mezigdomide combined with bortezomib and dexamethasone MeziVd against pomalidomide combined with bortezomib and dexamethasone PVd. This phase 3 study aims to understand which treatment better controls the disease and improves patient outcomes. Participants are randomly assigned to receive either the MeziVd or PVd treatment. Each drug is given at specified doses on certain days, though exact schedules are not detailed here. The study is open-label, meaning both participants and researchers know which treatment is being given. The trial includes multiple centers and continues over a period that may last up to about five years. During the study, participants will be closely monitored through various assessments including measurements of disease progression and survival. Researchers will track progression-free survival, overall response, duration of response, and quality of life among other outcomes. Safety is assessed by monitoring adverse events throughout the study. Participation involves regular visits for treatment and evaluations, and the study may last several years depending on individual patient progress and follow-up.

Researchers are conducting a study to develop and improve new diagnostic biomarkers using the LumiraDx Platform. This platform aims to enhance the ability of clinicians and patients to monitor chronic health conditions at the point of care by providing results comparable to approved gold standard methods. The study includes patients with conditions related to embolism, infection or inflammation, cardiovascular, and renal diseases. The study involves collecting blood samples from up to 20,000 patients, including venous blood and capillary fingerstick samples. Sample collection is divided into two phases Phase 1 collects venous blood tested using LumiraDx and reference methods, while Phase 2 includes both venous and fingerstick samples tested similarly. Samples will be anonymized and sent to LumiraDx UK Ltd for storage and future testing to optimize and calibrate new biomarkers. Participants will spend up to 45 minutes in the study, during which blood samples are collected, ideally alongside standard care blood draws. Data on patient demographics, medical history, and current medications will be recorded. The primary outcome is to measure blood samples from patients with various conditions using both reference and LumiraDx methods over up to five years. Patients may be re-sampled up to three months after initial consent, with limits on total blood volume collected.

Researchers are evaluating the safety and performance of the RTD Wound Dressing compared to the current standard care device used by the NHS for treating non-infected neuropathic, ischaemic, and neuro-ischaemic diabetic foot ulcers. This clinical evaluation is conducted in an open-label, randomized design within NHS Lanarkshires diabetic foot clinics. The primary goals are to assess complete wound healing and reduction in wound area after 12 weeks. Participants will be randomly assigned to either receive the RTD Wound Dressing, which is already CE marked and used for its intended purpose, or the NHS standard dressing normally used in podiatry clinics. Both groups will continue their regular NHS podiatry appointments. The study compares outcomes between these two groups over the 12-week period. During the study, participants will attend routine clinic visits where wound healing progress, wound area reduction, infection rates, and dressing changes will be monitored. Researchers will use medical photography and other evaluations to track healing and safety. Participants must be able to follow instructions and provide informed consent. The total follow-up period is 12 weeks with assessments focused on wound healing and related outcomes.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This phase 3 global trial aims to see if this drug can reduce serious heart failure events like hospitalizations, urgent visits, and cardiovascular deaths, while improving heart failure symptoms. The study is event-driven and includes a double-blind period followed by an open-label extension. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial consists of two parts, with Part 1 ending when about 850 primary endpoint events have occurred. The study includes a double-blind treatment period and an open-label extension phase where all participants can receive the drug. During the trial, participants will undergo regular assessments including measurements of heart failure events, cardiovascular deaths, and symptom changes using the Kansas City Cardiomyopathy Questionnaire. Other evaluations include blood pressure, body measurements, kidney function, cholesterol, and blood markers related to heart failure and diabetes. The primary outcome is the time to the first cardiovascular death or heart failure event, measured over up to approximately 35 months. Safety and drug levels will also be monitored throughout the study.

This research aims to evaluate the effects of lowering blood phosphate levels in adults with end-stage kidney disease ESKD who are receiving dialysis. Elevated phosphate levels are common in ESKD and linked to higher risk of death and heart problems, but it is unclear if reducing phosphate improves important patient outcomes. The study will compare intensive lowering of phosphate to a more liberal phosphate target to see if this reduces heart-related deaths and events, improves physical health, and is cost-effective. Participants will be randomly assigned to one of two groups one aiming for a liberal serum phosphate target of 2.0 to 2.5 mmolL, and the other aiming for an intensive target of 1.50 mmolL or lower. Doctors will decide the type and dose of phosphate-lowering medications to help participants reach their assigned phosphate levels, following usual local practices. The study will last up to five years and is conducted internationally with 3600 adults on dialysis. During the study, researchers will monitor participants for major heart-related events and deaths, physical health, fatigue, quality of life, patient satisfaction, and itching. Regular assessments will include measuring time to cardiovascular death or major cardiovascular events and evaluating overall survival and quality of life using the EQ5D-5L tool. The study will also assess cost-effectiveness and continue to observe participants for five years to collect comprehensive data on these outcomes.

Diffuse large B-cell lymphoma DLBCL is a fast-growing and uncommon cancer affecting certain immune cells, and it is the most common type of non-Hodgkin lymphoma. Follicular lymphoma FL is a slower-growing form of non-Hodgkin lymphoma. This research aims to evaluate how well the investigational drug epcoritamab works in adults with advanced DLBCL and FL in real-world medical settings. Participants will receive epcoritamab as prescribed by their doctors following local country guidelines. The study will include about 700 adults treated across roughly 80 sites in 12 to 20 countries. Treatment is given as subcutaneous injections, and the study observes participants over up to three years to gather effectiveness information. During the study, participants will continue their regular hospital or clinic visits as part of their usual care, without extra procedures or visits added by the trial. Researchers will monitor the percentage of participants who achieve an overall response to the treatment over approximately three years. The study is observational, meaning it follows patients receiving epcoritamab under normal clinical practice without altering their care.

Researchers are investigating the effects of balcinrenone combined with dapagliflozin compared with dapagliflozin alone in patients with chronic heart failure HF and impaired kidney function who recently experienced a heart failure event. This Phase III international study aims to evaluate the impact on cardiovascular death and heart failure events, including hospitalizations and events without hospitalization. The study is led by AstraZeneca and involves multiple centers worldwide. Participants will be randomly assigned to one of three groups a combination of balcinrenone and dapagliflozin at two different doses or dapagliflozin alone. Each participant will take one capsule and one tablet once daily, with placebos provided to maintain blinding. The study lasts about 22 months, including screening, a 20-month blinded treatment period, and a one-month follow-up during which all receive dapagliflozin openly. During the study, participants will be monitored for cardiovascular death and heart failure events, using measures such as hospitalizations and symptom assessments. Regular evaluations will track the timing of these events over approximately 38 months. Safety and health status will be followed closely, with a final follow-up phase to assess ongoing outcomes after the blinded treatment period.

Oropharyngeal squamous cell carcinoma OPSCC is a common type of throat cancer in Scotland that has been increasing, especially cases linked to human papillomavirus HPV. This research evaluates blood-based tests that detect tumour DNA fragments in the blood, aiming to improve diagnosis, monitor treatment response, identify early relapse, and assist clinical decisions for both HPV positive and negative OPSCC patients. The study focuses on developing advanced genetic assays to improve patient care and quality of life. The study involves analyzing circulating tumour-derived DNA ctDNA from blood samples, known as liquid biopsy, which is less invasive than surgical biopsy. Researchers will expand their current group of HPV positive patients to assess the clinical value of HPV DNA analysis in blood for monitoring treatment and relapse. For HPV negative patients, new diagnostic tests will be developed using genomic analysis of tumour and blood DNA to find biomarkers and targets for personalized treatment. Participants will provide blood samples that will be regularly tested to track tumour DNA levels, helping to assess treatment success and detect relapse early. Researchers will measure tumour burden over a three-year period using sensitive DNA detection methods. The study will monitor both HPV positive and negative patients with OPSCC to improve disease management. Participation involves ongoing follow-up to understand how tumour DNA in blood reflects treatment outcomes and disease progression.

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.