Middlesbrough

Researchers are evaluating two different methods of pacing the heart in patients with slow heart rates (bradycardia). This multi-center randomized controlled trial, called PROTECT-HF, aims to compare the standard right ventricular pacing approach with a newer physiological pacing technique, which includes His bundle and left bundle area pacing. The study will enroll 2600 patients to assess differences in outcomes related to heart function and survival. Participants will be randomly assigned to receive either right ventricular pacing or physiological pacing through pacemaker implantation. The physiological pacing method may involve His bundle pacing or left bundle pacing, with biventricular pacing used if these are not possible. Both treatments will be performed at participating centers, with patients and outcome assessors blinded to the treatment allocation. A subgroup of 500 patients will also take part in an optional echocardiographic sub-study to observe heart changes over 24 months. During the study, participants will be monitored from the time of consent for up to 78 months. Evaluations will occur at the start and every six months afterward to track mortality and heart failure-related health events. Researchers will gather data on heart function, treatment effects, and safety. The main analysis will consider all patients as originally assigned, and additional analysis will assess those who received the assigned treatment.

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly injection under the skin, in people with mild to moderate calcific aortic valve stenosis. This study aims to see if pelacarsen can safely slow the progression of this heart valve condition compared to a placebo. The trial is a phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. Participants will receive either pelacarsen 80 mg or a matching placebo once a month. Before starting the treatment, they must have elevated lipoprotein(a) levels and be optimally treated for existing cardiovascular risk factors. The study focuses on those aged 50 to under 80 years with mild or moderate calcific aortic valve stenosis. During the 36 months of participation, researchers will monitor changes in peak aortic jet velocity and aortic valve calcium score to assess disease progression. Safety, tolerability, and the impact of the treatment will be evaluated. Participants will undergo regular assessments, including laboratory tests and clinical evaluations, to track heart valve condition and overall health throughout the study.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating new treatments for men with prostate cancer that has spread to other parts of the body and still responds to hormone therapy. This Phase 3 trial compares two additional therapies with the best standard care to see if they slow cancer spread and improve survival. Participants from diverse backgrounds across multiple UK hospitals are involved, and the study is managed by University College London. The trial has two main comparisons. In Comparison S, participants receive either standard care alone or with added targeted high-dose radiotherapy (Stereotactic Ablative Body Radiotherapy or SABR) aimed at metastatic lesions. In Comparison P, participants receive standard care alone or with a radioactive drug (177Lu-PSMA-617) that targets prostate cancer cells. Standard care includes long-term hormone-reducing therapy and may include other approved medications or treatments. Treatments are given according to specific schedules: SABR is delivered in 3-5 sessions over 1-2 weeks, while 177Lu-PSMA-617 is given in up to three 6-week cycles. Participants are randomly assigned to either standard care or the new treatment with equal chance. During the study, participants undergo regular scans and tests to monitor cancer and side effects. Doctors track treatment safety and may stop treatment if side effects become serious or participants choose to stop. The main outcome measured is overall survival, with final results expected around 5 to 7 years after the first patient starts treatment. Participants' health status and response to treatment are closely observed throughout the study period.

Researchers are investigating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure with reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This Phase 2 study compares CDR132L to a placebo, where participants receive either treatment randomly. The study aims to evaluate changes in a specific biomarker, microRNA-132-3p, over 24 weeks, with the total study duration lasting about 60 weeks. Participants will receive either CDR132L or a placebo through an intravenous infusion once every 4 weeks for a total of 48 weeks. The treatments are given under a double-blind design, meaning neither the participants nor the researchers know who receives which treatment until the study ends. This allows for a fair comparison of the effects of CDR132L versus placebo on heart structure and function. During the study, participants will undergo regular assessments including laboratory tests to measure heart-related biomarkers and imaging tests such as echocardiography to monitor heart structure and function. Researchers will track changes from baseline to week 24 in microRNA-132 levels and continue monitoring participants through the 60-week study period to evaluate safety and treatment effects. Ongoing clinical evaluations and safety checks will help ensure participant well-being throughout the trial.

Researchers are evaluating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. This phase 2 study compares different doses of CDR132L with a placebo, which is an inactive treatment. The study aims to understand the safety and effectiveness of CDR132L in reversing heart remodeling in this population. Participants will receive either CDR132L or placebo administered intravenously once every 4 weeks. The study treatment period lasts about 24 weeks, followed by additional assessments leading up to a total study duration of approximately 60 weeks. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the main phase. During the study, participants will undergo various evaluations including heart imaging via echocardiography to measure heart function and structure, laboratory tests including NT-proBNP levels, and monitoring of heart failure symptoms. The main outcome measured is the change in normalized microRNA-132-3p levels from baseline to week 24. Researchers will also monitor safety and treatment effects throughout the study, which includes regular visits and assessments over the full 60-week period.

Researchers are evaluating treatments for participants with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. This Phase 3 study compares if the combination of belantamab mafodotin, lenalidomide, and dexamethasone (BRd) can extend progression-free survival or increase the number of participants achieving minimal residual disease negative status compared with the combination of daratumumab, lenalidomide, and dexamethasone (DRd). Participants will receive either BRd or DRd treatment. Belantamab mafodotin, lenalidomide, and dexamethasone will be administered in the BRd group, while daratumumab, lenalidomide, and dexamethasone will be given in the DRd group. The study will monitor participants over approximately 7 years to assess long-term outcomes. During the study, participants will undergo assessments to measure progression-free survival and minimal residual disease status. Researchers will collect clinical data, laboratory tests, and safety information throughout the treatment and follow-up periods. The total duration of participation may last up to about 7 years to evaluate long-term effects and outcomes of the treatments.

Researchers are evaluating patient-reported satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in adults with lung cancer or hepatocellular carcinoma treated in routine clinical practice. This non-interventional, multicenter, multicountry study collects primary data on health-related quality of life and treatment satisfaction for participants receiving Atezolizumab for approved indications. The study focuses on patients with specific lung cancer subtypes and advanced liver cancer who meet defined criteria regarding prior treatments and tumor characteristics. Atezolizumab is given subcutaneously at the discretion of the treating physician independently of study participation. Patients eligible for the study include those with early-stage or metastatic non-small cell lung cancer (NSCLC) with specific PD-L1 expression and genetic profiles, extensive-stage small cell lung cancer (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) not previously treated with systemic therapy. Treatment administration follows routine clinical practice, with no experimental interventions assigned by the study. Participants complete questionnaires assessing their satisfaction with Atezolizumab treatment and health-related quality of life during cycles 2 and 3 of therapy, each lasting three weeks. The primary outcome measure is the Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) score at these cycles. Safety and effectiveness data are monitored as part of routine care. The study collects data on patient experiences to better understand the real-world use of Atezolizumab over the treatment period.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.