Airdrie

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effectiveness and safety of a new drug combination called Mezigdomide (CC-92480) with bortezomib and dexamethasone (MeziVd) compared to an existing combination of pomalidomide, bortezomib, and dexamethasone (PVd). This study focuses on adults with relapsed or refractory multiple myeloma (RRMM) who have previously received between one and three lines of therapy, including prior lenalidomide treatment. The trial is a Phase 3, randomized, multicenter, open-label study aiming to improve outcomes for this condition. Participants will be assigned to receive either the MeziVd or PVd treatment regimen, with specified doses of each drug given on certain days. The study involves two treatment groups: one receiving mezigdomide, bortezomib, and dexamethasone, and the other receiving pomalidomide, bortezomib, and dexamethasone. Both regimens follow precise dosing schedules as determined by the study protocol. During the study, participants will be monitored regularly for disease progression or death, with the primary outcome being progression-free survival over up to approximately five years from the date of randomization. Ongoing assessments will include evaluations of safety and effectiveness. The total participation time may vary, and researchers will closely follow participants to gather detailed information on treatment responses and adverse effects.

Researchers are studying new diagnostic biomarkers on the LumiraDx Platform to improve the ability of clinicians and patients to monitor chronic health conditions such as embolism, infection or inflammation, cardiovascular, and renal diseases. This research compares these new biomarkers to gold standard reference methods, aiming to deliver faster results at the point of care. The study involves up to 20,000 patients from various medical settings, including emergency departments, hospital wards, and outpatient clinics. Participants will have blood samples collected in two phases depending on research needs. In Phase 1, only venous blood samples will be drawn and tested on the LumiraDx system and compared to reference methods. In Phase 2, both venous blood and capillary fingerstick samples will be collected and tested similarly. Sample processing may occur at clinical sites or LumiraDx UK Ltd. Samples will be anonymized and stored for future testing and development of biomarkers such as Troponin, NT-pro BNP, BNP, D-Dimer, and others. Each participant's involvement lasts up to 45 minutes per visit, with a maximum of 24mL of venous blood and 6 fingersticks collected within three months. Patients may be asked to participate again at subsequent visits, with a total sample limit maintained. Data collected includes demographics, medical history, medications, test results, and diagnoses. Blood samples will be measured using both the new LumiraDx method and standard reference methods over a period of up to five years to assess biomarker performance and device calibration.

The purpose of this clinical trial is to evaluate the safety and performance of the RTD Wound Dressing in the treatment of non-infected neuropathic, ischaemic, and neuro-ischaemic diabetic foot ulcers versus standard of care. This clinical evaluation study will be performed under an open-label, comparative, design in the single health board of NHS Lanarkshire within 3 diabetic foot clinics.

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.

This research aims to evaluate whether lowering blood phosphate levels in people with end-stage kidney disease (ESKD) who are on dialysis can reduce the risk of death or major heart-related events compared to maintaining higher phosphate levels. The study also looks at whether lowering phosphate improves physical health, fatigue, quality of life, patient satisfaction, and itching, as well as whether it is cost-effective. Hyperphosphatemia, or high phosphate in the blood, is common in ESKD and linked to higher death risk, but there is no strong trial evidence that lowering phosphate improves important patient outcomes. Participants will be randomly assigned to one of two groups: an intensive phosphate target group aiming to keep serum phosphate at or below 1.50 mmol/L using phosphate-lowering medications, or a liberal phosphate target group aiming for a higher phosphate range of 2.0 to 2.5 mmol/L. In the liberal group, all phosphate-lowering drugs at baseline will be stopped and only restarted if phosphate rises above 2.5 mmol/L. Medication choice and doses will be based on physicians' and participants' decisions to meet target levels. The trial is multinational and will include 3600 adults on dialysis. During the study, researchers will track major outcomes including cardiovascular death or serious heart and artery events over 5 years. They will also assess physical health, quality of life using the EQ5D-5L questionnaire, fatigue, itching, and overall survival. The study involves monitoring serum phosphate levels and medication use, and measuring cost-effectiveness of the treatment strategies. Participants will be followed closely to understand the safety and impact of the phosphate targets on their health and well-being.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive and rare cancer affecting white blood cells, and it is the most common form of non-Hodgkin lymphoma. Follicular lymphoma (FL) is a slower-growing type of this lymphoma. This study aims to evaluate the real-world effectiveness of the investigational drug epcoritamab in adult patients with advanced DLBCL and FL. Around 700 participants will be enrolled across approximately 80 sites in 12 to 20 countries worldwide. Participants will receive epcoritamab as prescribed by their doctors according to the approved treatment guidelines in their country. The study does not add any extra treatments or procedures beyond what their doctors recommend. Participants will be followed for up to about 3 years to observe their responses to the treatment. During the study, participants will attend regular visits at hospitals or clinics as part of their standard care routine. Researchers will track the percentage of participants who achieve an overall response to treatment over the study period. There is no expected additional burden for participants beyond their usual clinical visits and treatments.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.

Oropharyngeal squamous cell carcinoma (OPSCC) is a common throat cancer in Scotland, with cases rising in recent years, especially those linked to human papillomavirus (HPV). This study is exploring new blood-based tests that detect tumor DNA fragments in the bloodstream of OPSCC patients. These minimally invasive tests aim to improve diagnosis, monitor treatment response, detect relapse early, and support clinical decisions, especially for both HPV-positive and HPV-negative OPSCC, the latter having a poorer prognosis. The study involves monitoring circulating tumor DNA (ctDNA) in blood samples to assess treatment success and detect relapse in OPSCC patients. Researchers will expand evaluations of HPV DNA analysis in blood for HPV-positive cases and develop new genomic tests for HPV-negative cases. These approaches seek to provide better markers for disease monitoring and personalized therapy using advanced DNA detection and sequencing technologies. Participants will have their tumor DNA levels tracked longitudinally through blood tests over three years to assess response to treatment and early signs of relapse. This includes routine clinical assessments, imaging, and molecular analysis of blood samples. The study aims to improve patient care by providing more accurate, real-time disease monitoring and enhancing understanding of OPSCC molecular changes and treatment resistance.

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.