Chester

Researchers are evaluating the safety and effectiveness 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, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are evaluating the effectiveness of DT-101 in treating adults with Major Depressive Disorder (MDD). This Phase 2 clinical trial compares DT-101 to a placebo to understand its impact on depression symptoms and evaluates the safety and tolerability of the study drug. Participants have recurrent depression diagnosed by the latest DSM manual and are between 18 and 75 years old. Participants will receive either DT-101 or placebo in a double-blind, randomized manner. The study includes physical and neurological examinations, blood and urine sample collections, and clinical assessments to monitor ongoing suitability and gather data on the drug's effects. Blood samples will also be used to study how DT-101 is absorbed and metabolized and to explore genetic factors that may influence treatment response. During the study, participants will visit the clinic every few weeks to undergo general health checks and complete questionnaires. Researchers will measure changes in depression using the Montgomery Åsberg Depression Rating Scale (MADRS) from the start of the study to Day 42. Safety and adherence will be closely monitored throughout the trial, ensuring participant well-being and data accuracy.

Researchers are evaluating the effects of CIT-013 in adults with Hidradenitis Suppurativa (HS), a chronic skin condition. The study aims to determine if CIT-013 can reduce disease activity and to assess its safety. The trial compares two doses of CIT-013 to a placebo to understand if the treatment helps improve HS symptoms. Participants will receive either 50 mg or 100 mg of CIT-013 or a placebo through subcutaneous injections every two weeks for 12 weeks. The trial is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study focuses on two dose levels of CIT-013 and includes regular clinic visits for treatment administration and monitoring. During the study, participants will visit the clinic every two weeks for checkups and tests to monitor their symptoms and treatment effects. Researchers will measure the proportion of participants who achieve a significant improvement in HS symptoms by week 12. Safety and any medical problems during treatment will also be closely observed throughout the 12-week period.

This research evaluates treatments for acute lymphoblastic leukemia (ALL) in infants, children, and young adults up to 45 years old. It combines successful approaches from multiple European study groups into a master protocol with several randomized and interventional sub-studies. The goal is to improve survival rates while reducing treatment toxicity and relapse, especially focusing on better risk stratification and targeted therapies for different patient groups, including those with genetic differences and high relapse risk. The study uses a master protocol considered as standard care, with additional randomized interventions testing if treatment can be safely reduced in some risk groups or improved with new therapies in higher risk groups. Randomizations include testing omission of drugs like Doxorubicin or Vincristine+Dexamethasone pulses, adding Inotuzumab ozogamicin or 6-tioguanine to maintenance therapy, and treating certain patients with tyrosine-kinase inhibitors or Blinatumomab. The design allows flexible addition or stopping of sub-studies, and some interventions target specific patient subgroups such as those with ABL-class fusions or Down syndrome. Participants will undergo diagnosis confirmation and follow-up at participating centers and receive assigned treatments based on risk and randomization. Researchers monitor event-free survival, disease-free survival, and minimal residual disease response up to 5 to 8 years. Additional assessments include neurocognitive testing, pharmacokinetics of drugs like Imatinib and Asparaginase, cerebrospinal fluid analysis, and quality of life evaluations. Safety and long-term outcomes are closely tracked, with at least 5 years of follow-up for most measures.

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.

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 maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating the prevention of venous thromboembolism (VTE), which can be a serious complication after an acute stroke. This study is focused on immobile stroke patients who cannot walk without help and aims to compare two methods to prevent VTE during a 90-day follow-up period. The study compares the current standard treatment, Intermittent Pneumatic Compression (IPC), with a medical device called the geko17; device, which uses neuromuscular electrical stimulation to improve blood flow and potentially reduce VTE risk. Participants will be randomly assigned to receive either the IPC treatment, which involves air-filled cuffs squeezing the lower legs, or the geko17; device stimulating the peroneal nerve. Both treatments will be applied until the patient can walk independently or for up to 30 days. Leg compression Doppler scans will be done at 7 days (optional) and 14 days (mandatory) after randomisation. At 14 days, patients will also complete a questionnaire about device comfort and provide health information. Additional data on symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) will be collected from medical records at 30 days. During the study, participants will be monitored through scans, questionnaires, and medical record reviews to track any occurrences of DVT or PE. A final follow-up call at 90 days will assess the patient's recovery, health status, mobility, and quality of life. The main outcome measured is the frequency of symptomatic or asymptomatic DVT in the leg veins or any PE from randomisation up to 30 days. This comprehensive monitoring aims to provide clear information about which prevention method may better support immobile stroke patients.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Researchers are exploring new methods to improve the early diagnosis of lung cancer by analyzing blood samples from participants. This study aims to create tools that make it easier to screen individuals with possible lung health issues, diagnose problems earlier with fewer tests, and begin effective treatments sooner. The study is linked with the DART study and uses artificial intelligence to support faster and more accurate diagnosis of lung problems, including lung cancer. Blood samples collected from participants will be used to develop computer programs called algorithms that analyze medical data. These algorithms are trained to detect lung health problems and can assist doctors in identifying issues more quickly and accurately. The goal is to improve lung health care by integrating AI with existing screening programs. Participants will have their blood samples collected and linked with data from CT scans and other lung health checks. The study will monitor how well these AI-based tools perform in diagnosing lung cancer compared to current methods. The primary outcome is to develop an algorithm that improves lung cancer diagnosis by February 2025. Participant involvement includes providing consent and undergoing lung cancer screening procedures as part of the Lung Health Check programme.