Chester

Researchers are evaluating brenipatide, compared to a placebo, in adults with moderate-to-severe Alcohol Use Disorder AUD. This study aims to assess how brenipatide affects drinking patterns and its safety over a period of approximately 56 weeks. The trial is a phase 3, multicenter, randomized, double-blind study sponsored by Eli Lilly and Company. Participants will receive escalating doses of brenipatide or placebo, administered by subcutaneous injection. The study includes multiple experimental periods where participants receive the study drug or placebo under controlled conditions. The dosing is carefully monitored to assess the drugs effects compared to placebo. During the study, participants will undergo regular assessments including drinking behavior tracked by the Timeline Followback Method, craving levels measured by the Penn Alcohol Craving Scale, and health outcomes collected through questionnaires. Safety will be monitored by evaluating laboratory tests and adverse events. The total participation lasts up to 56 weeks with ongoing monitoring throughout this period.

Researchers are evaluating the efficacy and safety of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international study is a randomized, double-blind, placebo-controlled trial designed to assess how finerenone affects morbidity and mortality in these patients. Participants are randomly assigned to receive either oral finerenone or a matching placebo. The study is event-driven and ongoing for up to about 30 months, focusing on heart failure events and cardiovascular deaths. The trial includes careful monitoring of adverse events and treatment discontinuation due to side effects. During the study, participants will be closely monitored for heart failure events, cardiovascular deaths, and changes in symptoms using the Kansas City Cardiomyopathy Questionnaire. Regular assessments will track serious adverse events and safety. The total duration of participation may last up to approximately 30 months, with ongoing follow-up to understand long-term effects of the treatment.

Researchers are evaluating the effects of DT-101 compared to a placebo in adults diagnosed with Major Depressive Disorder MDD. This Phase 2 clinical trial aims to assess how well DT-101 works and how safe and tolerable it is for participants with recurrent depression, as defined by current psychiatric guidelines. The study is led by Draig Therapeutics Ltd and includes adult participants aged 18 to 75 years. Participants will be randomly assigned to receive one of two versions of DT-101 or a placebo. The study uses a double-blind design, meaning neither the participants nor the researchers know who receives which treatment until the trial ends. The treatment period includes regular visits every couple of weeks where health checks and questionnaires will be completed. Blood and urine samples will be collected for safety monitoring and to study how the drug is absorbed and processed by the body, including potential genetic influences. Throughout the study, participants will undergo physical and neurological examinations, clinical assessments, and ongoing health reviews to ensure continued eligibility and safety. Questionnaires will measure changes in depression symptoms using the Montgomery sberg Depression Rating Scale MADRS and the Clinician Global Impression of severity CGI-S by day 42. The total duration of participation will extend through these assessments, with safety and treatment effects closely monitored during clinic visits.

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.

Researchers are evaluating a new treatment system called ALLTogether1 for infants, children, and young adults aged 0 to 45 years diagnosed with acute lymphoblastic leukaemia ALL. This European study combines previous successful treatments from multiple groups to improve survival and quality of life. It addresses the challenge that some patients are over-treated while others relapse, aiming to find better risk-based treatment approaches and reduce side effects and relapse rates. The study uses a master protocol with established standard therapies and includes several randomized sub-studies to test different treatment modifications. These include reducing or omitting certain chemotherapy drugs, adding targeted therapies like Inotuzumab ozogamicin, Imatinib, 6-tioguanine, or Blinatumomab, and tailoring treatment for specific genetic subgroups. The study design allows adding or stopping sub-studies to find less toxic but effective therapies for various risk groups. Participants will undergo diagnosis confirmation and risk stratification, followed by assigned treatments according to their risk category and randomization group. Assessments include measuring event-free survival, disease relapse, molecular responses, and adverse effects over at least five years. Additional sub-studies collect biological samples and evaluate cognitive function, drug activity, and treatment toxicities. Safety and long-term outcomes are closely monitored throughout the study period.

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 evaluating maridebart cafraglutide in adults aged 45 to 99 years who have atherosclerotic cardiovascular disease and are overweight or obese. The study aims to determine if maridebart cafraglutide, when added to standard care, is better than a placebo in reducing serious heart-related problems and deaths. This is a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Amgen. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given as subcutaneous injections. The study treatment is given alongside their usual care. The trial will last for approximately 35 months, during which time researchers will monitor cardiovascular events such as heart attacks, strokes, and deaths, as well as other health measures. During the study, participants will have regular visits for monitoring safety and health status. Researchers will assess heart-related events, blood pressure, body measurements, blood markers such as cholesterol and blood sugar levels, and kidney function. The main outcomes include time to first major cardiovascular event and changes in various health indicators over about three years. Safety monitoring will continue throughout the trial period.

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.