Chester

Researchers are evaluating brenipatide for adults with moderate-to-severe Alcohol Use Disorder AUD to see how it compares to a placebo in effectiveness and safety. This Phase 3, multicenter, randomized, double-blind study is led by Eli Lilly and Company and aims to better understand treatment options for AUD. Participants in this study will be adults aged 18 to 75 years and will remain in the study for about 56 weeks. Participants will receive either brenipatide or a placebo through subcutaneous injections. The study has multiple treatment periods with escalating doses of brenipatide administered under medical supervision. Both the active drug and placebo are given by injection under the skin. The study uses a randomized design to assign participants to one of the study groups to compare outcomes. During the study, participants will be regularly assessed using questionnaires and diaries to track drinking patterns, alcohol cravings, and overall health. Researchers will also monitor changes in alcohol consumption, body weight, and health survey scores. Blood tests will check drug levels and the presence of antibodies against brenipatide. Safety and treatment effects will be observed for up to 56 weeks, with study visits scheduled throughout this period.

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating the effect of DT-101 compared to placebo in adults with Major Depressive Disorder MDD. This Phase 2 clinical trial aims to assess the safety, tolerability, and impact of DT-101 on depression symptoms in adults aged 18 to 75 years who have recurrent depression diagnosed by DSM 5-TR. The study is randomized, double-blind, and placebo-controlled, focusing on treatment for this condition. Participants will be assigned to one of three groups two experimental groups receiving different formulations of DT-101 DT-101 A or DT-101 B or a placebo group. The study involves regular clinic visits every couple of weeks where the study drug or placebo is administered and ongoing assessments are conducted. Blood and urine samples will be collected to monitor the drugs absorption and use in the body, including optional genetic testing to explore responses to DT-101. During the study, participants will undergo physical and neurological exams, clinical assessments, and complete questionnaires about their health and depression symptoms. The primary outcome measure is the change in depression severity using the Montgomery sberg Depression Rating Scale MADRS over 42 days. Safety and tolerability will be monitored throughout. Participation involves multiple visits for health checks and data collection until the study concludes in August 2027.

Researchers are evaluating the effects of CIT-013 in adults with Hidradenitis Suppurativa HS, a chronic skin condition. This Phase 2a randomized, double-blind, placebo-controlled trial aims to find out if CIT-013 can reduce disease activity and to assess its safety. The study compares two doses of CIT-013 to a placebo to understand its impact on symptoms and medical issues experienced by participants. Participants will receive either a high dose 100 mg or medium dose 50 mg of CIT-013, or a placebo, through subcutaneous injections every other week for 12 weeks. The treatments involve six injections in total. The trial includes three groups one for each dose of CIT-013 and one for the placebo, all administered via injections under the skin. During the study, participants will visit the clinic every two weeks for checkups and tests. Researchers will monitor symptoms, measure disease activity using the HiSCR75 response at week 12, and track any treatment-related adverse events. Blood samples will be taken at various points to assess drug levels. The total study participation lasts for 12 weeks with regular monitoring throughout this period.

This research aims to improve treatment and survival quality for infants, children, and young adults aged 0 to 45 years with acute lymphoblastic leukaemia ALL. It combines experiences from multiple European study groups into a master protocol that offers comprehensive risk stratification and treatment plans. The study includes randomized and interventional trials to identify therapies that may be less toxic and more effective, particularly focusing on reducing relapse and treatment-related side effects. Participants receive treatment based on a master protocol considered standard care, with additional randomized interventions testing modifications like reducing or omitting specific chemotherapy drugs such as Doxorubicin, Vincristine, and Dexamethasone. Some patients receive experimental treatments including Inotuzumab ozogamicin, Imatinib, 6-tioguanine, and Blinatumomab. Specific sub-studies also examine pharmacokinetics, neurocognitive outcomes, and cerebrospinal fluid diagnostics. The study design allows modular addition or stopping of sub-protocols and interventions. Throughout the study, participants undergo various assessments including monitoring of disease progression, side effects, and drug activity. Researchers evaluate event-free survival, disease-free survival, minimal residual disease response, and overall survival over multiple years, with follow-up periods extending up to 8 years. Participants cognitive functions and treatment toxicities are also assessed using specialized tests and questionnaires. Safety and adverse events are closely monitored to better understand treatment impacts over time.

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.

Researchers are conducting a multi-centre observational study to better understand giant cell arteritis GCA and polymyalgia rheumatica PMR, conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.

Researchers are studying the nutritional content of breast milk from donors, focusing on the levels of important omega-3 and omega-6 fatty acids, docosahexaenoic acid DHA and arachidonic acid. These nutrients are essential for brain development and immune function, but donor milk in the U.K. has been found to have low levels. The study aims to develop and test nutritional information resources to help milk donors improve the quality of their milk, with potential benefits for preterm infants who receive donor milk. This open-label study lasts eight weeks and involves donors from the Countess of Chester Hospital milk bank. Participants complete an initial dietary questionnaire, give blood and breast milk samples, and receive nutritional resources. They are randomly assigned to either receive feedback on their milk DHA levels along with the resources or just the resources. Milk samples are collected at specified weeks and analyzed for fatty acid content. The study also collects detailed diet information through photo diaries submitted via a mobile app. Participants will have baseline and endpoint visits for sample collection, questionnaires, and consultations. Milk and blood samples are analyzed to measure omega-3 fatty acid levels. The study tracks changes in diet and milk DHA content to evaluate the resources effectiveness. Data collection includes dietary photos and feedback on milk DHA for some participants. The study plans to recruit 60 donors over eight months, with ongoing sample storage for future research.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

Researchers are evaluating the prevention of venous thromboembolism VTE, a serious condition that can occur after a stroke, in immobile patients. This study compares the current standard treatment, Intermittent Pneumatic Compression IPC, with a medical device called the geko device, which uses neuromuscular electrostimulation to increase blood circulation. The study focuses on whether the geko device can better prevent VTE during a 90-day follow-up period after stroke. Participants will be randomly assigned to one of two groups one receiving the geko device and the other receiving standard IPC treatment. The geko devices will be applied to both legs and changed every 24 hours, used continuously for up to 30 days or until the patient regains mobility. The IPC devices will also be applied to both legs and used up to 30 days or until recovery or discharge. Treatment will start soon after randomization. During the study, participants will have leg Doppler ultrasound exams at 7 days optional and 14 days mandatory to check for blood clots. At 14 days, patients will complete a questionnaire about device comfort and health information. At 30 days, medical records will be reviewed for any symptomatic deep vein thrombosis or pulmonary embolism. A final phone follow-up at 90 days will assess recovery, health, mobility, quality of life, and survival. Safety and device effectiveness will also be monitored throughout the study period.