Redhill

Researchers are evaluating two different pacing methods for patients with slow heart rates, called bradycardia. This study compares the common right ventricular pacing approach with a newer physiological pacing method that includes His bundle and left bundle area pacing. The trial aims to better understand how these pacing techniques affect patient outcomes, including mortality and heart failure morbidity, in a large group of 2600 patients. Participants will receive a pacemaker implant and be randomly assigned to either right ventricular pacing or physiological pacing. The physiological pacing may involve His bundle pacing or left bundle pacing, but if these are not successful, biventricular pacing will be used. A subgroup of 500 participants will take part in an optional echocardiographic sub-study to assess heart function changes over a 24-month period. Throughout the study, patients will be assessed at baseline and every six months after randomization, with follow-up lasting up to 78 months. Researchers will monitor outcomes such as mortality, heart failure events, device-related safety issues, patient quality of life, symptoms, and pacemaker-derived data like arrhythmias and activity levels. The echocardiographic sub-study will measure specific heart function changes to understand pacing-induced cardiomyopathy. Participants involvement includes implantation, regular follow-up visits, questionnaires, and optional imaging assessments.

Severe diabetic macular oedema DMO affects the central part of the retina called the macula, leading to sight loss due to fluid buildup from leaking blood vessels. This condition mainly occurs in adults with type 1 or type 2 diabetes and is measured by how thick the macula becomes in microns. This trial evaluates and compares the current standard treatment of anti-vascular endothelial growth factor anti-VEGF injections alone with a new approach where patients start with anti-VEGF injections and then switch to subthreshold micropulse laser SML treatment once the macula thickness decreases below 400 microns. Participants are randomly assigned to receive either continued anti-VEGF monotherapy or a combination where anti-VEGF treatment is followed by SML applied every 2-3 months after the macula thickness drops below 400 microns. Anti-VEGFs used include ranibizumab, aflibercept, faricimab, and brolucizumab, administered monthly initially and then spaced out as needed. SML is applied according to the study guidelines once the macula thins, aiming to reduce the number of injections required. During their participation, individuals will undergo regular optical coherence tomography OCT scans to measure macular thickness and visual acuity tests up to 104 weeks after randomization. Researchers will assess vision changes, macular thickness, quality of life, safety, treatment use, and participant experience. The study also includes follow-up questionnaires and qualitative interviews to understand patient preferences and the potential for wider implementation of the laser treatment strategy.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

This research is investigating the use of Implantable Cardioverter-Defibrillators ICDs in adults diagnosed with heart failure caused by Non-Ischemic Cardiomyopathy NICM, a condition where heart failure is not due to blocked arteries. The study aims to compare the all-cause mortality rates between patients who receive an ICD and those who do not, over a period of 36 months and extending up to 10 years. This trial addresses ongoing questions about whether ICDs benefit patients with NICM, especially given recent findings that many patients with ICDs do not experience serious heart rhythm problems. Participants are randomly assigned to one of two groups one group will have an ICD or Cardiac Resynchronisation Therapy Defibrillator CRTD implanted, which are devices designed to detect and correct dangerous heart rhythms. The other group will not receive an ICD but may have an Implantable Loop Recorder or a Cardiac Resynchronisation Therapy Pacemaker CRTP, alongside their usual medical care. The study will monitor both groups to determine if ICD implantation improves survival compared to no ICD over the study period. Throughout the trial, participants will be regularly evaluated with health assessments including quality of life questionnaires and monitoring of heart-related events such as hospitalizations and arrhythmias. Researchers will track outcomes like survival percentage, heart rhythm events, and device-related procedures over 3 years, with some outcomes also measured at 5 and 10 years. The study includes close observation of safety and effectiveness, with participants followed to understand long-term impacts of ICD therapy in this patient group.

Researchers are evaluating the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.

This trial is a rollover study for adults who previously participated in specific Incyte-sponsored clinical trials involving the drug povorcitinib. It focuses on people with Hidradenitis Suppurativa HS, a condition being studied to better understand the long-term safety and effects of continuing povorcitinib treatment. The purpose is to monitor participants who have already benefited from povorcitinib in earlier studies, now entering an extended phase to further evaluate safety and treatment outcomes. Participants will continue taking povorcitinib orally, following the same dose and schedule they had in their original parent study. This study does not test new doses or compare treatments but observes continued use of the drug under the established regimen. The study may last for up to approximately three years, reflecting extended monitoring rather than initial treatment phases. During the study, participants will attend scheduled visits for assessments, including tracking any treatment-emergent adverse events and measuring symptom counts related to HS. Researchers will collect safety data over the long term and observe clinical responses. Participants must adhere to study procedures and avoid pregnancy or fathering children as required. The study aims to provide detailed safety information over an extended period while participants remain on the drug regimen from their original trial.

The trial investigates the long-term safety, performance, and clinical benefits of pacing the left bundle branch area using the INGEVITY pacemaker lead in adults with bradycardia who require a pacemaker. This observational post-market clinical follow-up study aims to gather information on how well this pacing method works and its effects over time. Participants will receive an INGEVITY bipolar, steroid-releasing pacemaker lead implanted in the left bundle branch area, connected to a compatible Boston Scientific single- or dual-chamber pacemaker. The implantation is performed using a CE-marked catheter designed for chronic stimulation and sensing. This study focuses on patients receiving this specific Boston Scientific pacemaker system and lead combination. Throughout the study, participants will be monitored for implant success and maintenance of ventricular synchrony, assessed from the implant procedure through a three-year follow-up period. Evaluations include clinical visits and testing as outlined by the protocol. The study measures pacing performance and safety, with participants involved in ongoing assessments to track outcomes over several years.

This research aims to evaluate two types of ostomy seals or rings in patients who have recently undergone ostomy surgery. It focuses on preventing and managing complications related to the skin around the stoma, known as peristomal skin complications PSCs. The study is sponsored by Hollister Incorporated and involves post-operative patients with colostomy, ileostomy, or urostomy, assessing how these devices perform in real-world use. Participants will be randomly assigned to use either an absorptive ostomy seal or an ostomy ring containing Aloe. These devices are applied at the first pouch change following surgery or up to four days after the operation. The study treatment period lasts for nine weeks, during which patients use the assigned seal or ring as part of their ostomy care. The trial compares the two devices to monitor skin complications and other related outcomes. During the study, participants will be followed from enrollment through the nine-week treatment phase with regular assessments. Researchers will track skin complications using the Ostomy Complication Severity Index OCSI, including measures of leakage, moisture, skin conditions, and patient and clinician satisfaction. The study also collects data on usage patterns, healthcare visits related to the ostomy, and costs associated with the seals or rings. The overall goal is to understand the devices impact on skin health and patient experience after ostomy surgery.

Researchers are conducting a prospective, observational study to assess the health of multiple organs in adults with type 2 diabetes who have no history of cardiovascular disease. The goal is to understand if detailed MRI measurements can help predict future clinical events over a 5-year period. Participants include adults diagnosed with type 2 diabetes, especially those diagnosed within the last three years. Participants will undergo no changes to their standard medical care. The study involves two main visits within one month the first includes body measurements and collection of blood and urine samples for routine diabetes checks, and the second involves a multi-organ, multiparametric MRI scan. Data from these visits, along with access to medical records, will be used to monitor disease progression and predict outcomes over 1, 3, and 5 years. Throughout the 5-year study, researchers will collect MRI metrics, clinical outcomes, and lab samples to evaluate diabetes progression. Participants consent to access their hospital and mortality records for event tracking. The primary outcome is the rate of major cardiovascular events three years after the baseline MRI. Secondary outcomes include kidney, eye, liver, cancer, and mortality events assessed at 1, 3, and 5 years. The study requires only a short period of active participation, with long-term follow-up through record review.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.