Southend On Sea

Researchers are evaluating the accuracy of an artificial intelligence software called Osteo Signal in detecting osteoporosis risk in adults aged 50 years and older. The study compares the software's ability to identify osteoporosis risk using chest x-ray images against the standard method of dual-energy x-ray absorptiometry (DXA). This research uses existing data from individuals who have already undergone both chest x-rays and DXA scans, focusing on osteoporosis and osteopenia conditions. The study involves analyzing past posteroanterior (PA) chest x-rays and DXA scans taken within 6 months of each other from January 2010 onward. Osteo Signal, the AI software device, is used to assess the chest x-rays for osteoporosis risk. There is no direct treatment or intervention for participants, as the study is retrospective and observational, using paired imaging data to evaluate the AI software's performance. Participants are not directly involved since the study uses previously collected imaging and medical data. Researchers review the quality and completeness of chest x-rays and DXA scans along with participant metadata such as age and sex. The main outcome measured is the classification of bone status as osteoporosis or non-osteoporosis, based on the paired chest x-ray and DXA scan results. The study also monitors for any technical or medical factors that might affect image analysis or data accuracy.

Researchers are evaluating adults aged 18 and older who have a specific eye condition called centre-involved diabetic macular edema (CI-DME), a type of diabetic macular edema. The study aims to find out whether an oral medicine called BI 1815368 can improve vision in people with CI-DME and to determine the best dose. This is a Phase 2 study focused on assessing the medicine's safety, efficacy, and tolerability over 48 weeks of treatment. The study has two parts. In the first part, participants are randomly assigned to one of two equal groups: one group takes BI 1815368 tablets and the other takes placebo tablets, which look like the medicine but contain no active drug. In the second part, participants are randomized into four groups of equal size, three of which receive different daily doses of BI 1815368, while one group continues to take placebo. All participants take tablets twice daily for about 11 months. Participants stay in the study for about a year and visit the study site 16 times. During visits, doctors check vision and collect detailed eye pictures along with health information. Researchers compare changes in vision and eye condition over time between the groups. The main outcome measured is whether participants gain 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of visual acuity at week 48 compared to baseline, indicating improved sight.

Researchers are evaluating the use of non-vitamin K oral anticoagulants (NOACs) compared to no anticoagulation in people who have experienced transient atrial fibrillation episodes triggered by stress and have additional risk factors for stroke. This multinational, investigator-initiated Phase 4 trial aims to prevent stroke and other serious cardiovascular events in this group by assessing the effects of NOACs on two main outcomes: the occurrence of non-hemorrhagic stroke or systemic embolism, and a combination of vascular death and other major cardiovascular problems, over a follow-up period lasting until the last participant reaches 24 months of observation. Participants in the study are randomly assigned to either receive one of several NOAC medications—edoxaban, apixaban, dabigatran, or rivaroxaban—with dosing adjusted as needed and chosen by their prescribing doctor, or to receive no oral anticoagulation. The treatment continues throughout the follow-up period. The trial is open-label, meaning both researchers and participants know which treatment is given. The study specifically focuses on patients who had transient atrial fibrillation related to stress, such as after certain surgeries or acute medical illness. During the study, participants undergo regular monitoring to track the incidence of stroke, embolism, vascular death, heart attacks, blood clots, and other cardiovascular events. Researchers collect information over up to two years to evaluate these outcomes. Safety and adherence to treatment are also monitored. This thorough follow-up helps determine the impact of NOAC treatment compared to no anticoagulation in this particular patient population.

Researchers are evaluating whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

Benign prostatic hyperplasia (BPH) is a common condition affecting men, especially as they age, with up to 90% of men experiencing it by age 80. This research aims to create an ongoing international registry to collect and analyze demographic and clinical data from men with BPH who receive either medical therapy or surgical treatments. The registry helps track treatment patterns and outcomes worldwide to better understand the effectiveness and complications related to various BPH treatments. The registry collects detailed baseline information including patient-reported symptoms, sexual health, quality of life, urinary flow, and laboratory values such as prostate-specific antigen and testosterone. It also records any complications like bleeding, infections, incontinence, strictures, ejaculation issues, and erectile dysfunction. This data is gathered over a three-year period with no set endpoint, allowing for long-term follow-up and analysis of real-world treatment results. Participants provide medical records which are securely stored and accessed only by authorized users. The study monitors symptoms using standardized scores and quality of life measures, along with clinical tests such as post-void residual urine volume. Regular audits ensure data accuracy, and the registry’s technology supports future integration with patient portals and electronic medical records. The study duration is planned for at least three years, with possible extensions to continue follow-up and research.

This research aims to understand the genetic factors that contribute to the risk of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR). GCA is a serious inflammatory disease affecting blood vessels, mainly in people over 50, which can cause severe complications like vision loss or stroke if untreated. PMR causes pain and stiffness in the limbs with signs of inflammation. The study involves both patients recently suspected of having GCA and those with confirmed diagnoses from the past. It seeks to provide new insights into disease causes and improve diagnosis and treatment approaches. Participants are observed in a multi-center study collecting clinical and genetic data. The study includes both prospective patients with suspected GCA and retrospective patients with confirmed GCA or PMR diagnoses. Some retrospective participants receiving tocilizumab for recurring or difficult-to-treat GCA are also included in a safety monitoring registry. Data collected include clinical features, imaging, tissue and blood samples, and advanced genetic testing. The study also follows patients over time to assess disease impact, quality of life, and long-term outcomes. During the study, participants provide medical information, biological samples, and complete questionnaires about their symptoms and quality of life. Researchers monitor disease activity and treatment effects, especially among those starting certain immune-modifying drugs. The main measurements focus on genetic susceptibility at the study start, with ongoing evaluation of diagnosis, prognosis, and disease progression. The study is designed to improve understanding and management of GCA and PMR over time.

Researchers are evaluating the safety and performance of remote monitoring functions in pacemakers, specifically the ALIZEA, BOREA, and CELEA devices. These remote features include the Right Atrial Autothreshold (RAAT), Right Ventricular Autothreshold (RVAT), and technical remote alerts. The study focuses on patients with bradycardia who have recently received one of these pacemakers as part of their cardiac care. Participants will undergo implantation or device upgrade with an ALIZEA, BOREA, or CELEA dual chamber pacemaker. The study involves activating remote monitoring functions on these devices to track cardiac pacing performance and system safety. Follow-up visits will occur at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months after inclusion, during which device function and remote monitoring data will be assessed. During each follow-up, either in person or remotely, researchers will measure the pacemaker's performance, including pacing thresholds and remote alerts. Safety will be closely monitored throughout the entire 48-month study period. The main outcomes include changes in right atrial and right ventricular pacing thresholds and documentation of technical remote alerts between 1 and 3 months after device implantation.

Researchers are evaluating the effects of using multiple arterial grafts (MAG) versus a single arterial graft (SAG) in women undergoing coronary artery bypass grafting (CABG). This international, multi-center randomized trial named ROMA:Women aims to determine whether MAG improves major heart and brain-related events and quality of life compared to SAG. The study includes 2,300 women to examine outcomes like death, stroke, heart attacks, repeat surgeries, and hospital stays, along with quality of life and mental and physical health symptoms in a subgroup of 500 participants. Important patient subgroups such as age, diabetes status, race, surgical techniques, and type of arterial grafts will also be analyzed. Participants will be randomly assigned to receive either single arterial grafting, where the left internal thoracic artery is connected to the heart's left anterior descending artery along with venous grafts, or multiple arterial grafting, where an additional arterial graft such as the right internal thoracic artery or radial artery is used for other coronary branches, plus other grafts as needed. The trial leverages existing infrastructure and continues enrollment with additional sites to reach its target sample size. Both treatment arms follow the same randomization, interventions, and follow-up protocols as the parent ROMA trial. During the study, researchers will monitor participants for at least 2.5 years after surgery to track major cardiac and cerebrovascular events and assess disease-specific and generic quality of life measures using questionnaires such as the Seattle Angina Questionnaire and PROMIS-29. The trial will collect data through clinical assessments and questionnaires to evaluate health outcomes and symptom changes. Safety and effectiveness will be closely followed to understand the impact of the two grafting methods in women undergoing CABG.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating the effectiveness and safety of sonelokimab compared with placebo in adults with active psoriatic arthritis who have not responded well or could not tolerate anti-tumor necrosis factor alpha (TNFb1) therapy. This Phase 3, randomized, double-blind study also includes risankizumab as an active reference treatment to better understand the benefits and risks of sonelokimab for this condition. Participants will be randomly assigned to one of four groups receiving either sonelokimab at doses of 60 mg or 120 mg, placebo, or risankizumab. The treatments are given by injection under the skin. The study is conducted across multiple centers and compares the response rates after 16 weeks of treatment to evaluate improvement in psoriatic arthritis symptoms. During the trial, participants will undergo joint assessments, blood tests for specific antibodies, and evaluations of skin psoriasis. Researchers will monitor how many participants achieve at least a 50% improvement in arthritis criteria compared to placebo. Safety and side effects will be closely observed throughout the study. The total time involved includes screening, treatment, and follow-up visits to ensure thorough evaluation of both effectiveness and safety.