Bedford

Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease CAD. This observational registry focuses on individuals treated with this specific stent and planned for a short dual antiplatelet therapy DAPT of up to 3 months. The study aims to collect real-world data on clinical outcomes including safety and effectiveness over a 12-month period. Participants in this single-arm registry have undergone percutaneous coronary intervention PCI using the Vivo ISAR stent and will receive standard care short DAPT treatment for no more than 3 months. The study does not affect treatment choices or standard care procedures. After the PCI, eligible patients will be invited to join the registry and followed up at 1 month, 3 months, and 12 months. During the study, researchers will collect baseline medical data and conduct telephonic follow-ups at 30 days, 3 months, and 12 months. These follow-ups will check on medication use, laboratory assessments, adverse events, and any further interventions. The main outcomes measured include ischemic and bleeding events at 12 months, along with secondary outcomes such as mortality, heart attacks, strokes, stent thrombosis, and need for additional vessel treatments. The total participation duration is one year from the PCI procedure.

Researchers are evaluating KT-621, an oral drug, for its safety and effectiveness in treating adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b randomized, double-blind, placebo-controlled trial aims to understand how KT-621 affects lung function and asthma control compared to a placebo. The study is sponsored by Kymera Therapeutics, Inc. and seeks to provide detailed information on KT-621s behavior in the body and its tolerability. Participants will be randomly assigned to one of four groups receiving different doses of KT-621 or a matching placebo. The treatment period lasts 12 weeks, during which participants take the study drug orally. The trial includes regular assessments to monitor lung function, asthma symptoms, and quality of life, with additional follow-up extending to 16 weeks to evaluate safety and drug levels in the blood. Throughout the study, participants will attend scheduled visits for lung function tests, questionnaires about asthma control and quality of life, and blood sampling to measure drug concentration and monitor safety. Researchers will track changes in lung function from the start through Week 12 and observe any adverse events up to Week 16. Participants are expected to comply with all study visits, treatments, and procedures, including keeping an electronic diary to record relevant health information.

Researchers are evaluating the effectiveness and safety of a new drug called GSK3862995B in adults with bronchiectasis, a chronic lung disease. This Phase 2 study also examines how the body processes the drug and checks for any immune reactions. Participants will be randomly assigned to receive one of two doses of GSK3862995B or a placebo to compare their effects on bronchiectasis. Participants will receive either Dose Level 1 or Dose Level 2 of GSK3862995B, or a matching placebo. The study uses a double-blind, randomized design, meaning neither participants nor researchers know who gets which treatment. The treatment period lasts up to 48 weeks, during which participants receive repeated doses. The study also includes assessments up to 72 weeks to monitor safety and immune responses. During the trial, participants will undergo evaluations including lung function tests, quality-of-life questionnaires, and monitoring of respiratory symptoms. Researchers will track the number of lung exacerbations, serious adverse events, laboratory tests, vital signs, and electrocardiograms to assess safety and effectiveness. Participants will be involved in regular visits and assessments throughout the treatment and follow-up periods, lasting up to about 72 weeks in total.

This research aims to collect daily urine samples from women who are trying to conceive to maintain the SPD Biobank. The study includes women with regular menstrual cycles who have either become pregnant or not, along with related information like age, menstrual days, and reproductive hormone levels. Volunteers will use a Clearblue Ovulation product to help identify their fertile days and support conception efforts. Participants will collect daily early morning urine samples throughout the study period, which lasts up to three menstrual cycles if pregnancy does not occur or up to day 60 if pregnancy is confirmed. They will also keep a daily diary recording their menstrual cycles, urine sample collection, and pregnancy test results. The urine samples will be sent to a clinical laboratory for hormone testing, then stored frozen in the SPD Biobank for future research and product evaluation. During the study, participants will provide urine samples and maintain their diaries as instructed. Researchers will measure hormone levels related to fertility and pregnancy from the collected samples. The study offers ongoing monitoring through sample collection and diary updates for up to 3 cycles or day 60 of pregnancy. This observational study is led by SPD Development Company Limited and includes women aged 18 and older who are actively trying to conceive.

Researchers are studying the use of depemokimab as an additional treatment for adults aged 40 to 75 with moderate to severe Chronic Obstructive Pulmonary Disorder COPD who also have type 2 inflammation. The goal is to evaluate the effectiveness and safety of starting depemokimab early alongside the standard care these patients already receive. This study is a Phase 3 trial designed to better understand how depemokimab might help reduce COPD exacerbations in this specific group. Participants will be randomly assigned to receive either depemokimab or a matching placebo, both given in combination with their existing standard treatments for COPD. The treatment period lasts up to 156 weeks about 3 years, during which the study compares the rate of moderate to severe COPD flare-ups between the two groups. This trial uses a parallel design with quadruple masking to maintain objectivity and includes ongoing standard care throughout. Throughout the study, participants will have regular evaluations to monitor their lung function, symptoms, and quality of life using questionnaires like the St. Georges Respiratory Questionnaire and the Evaluating Respiratory Symptoms E-RS for COPD. The main outcome measured is the annual rate of moderate or severe exacerbations over the study period. Safety and response to treatment will be closely observed, with follow-up continuing until the primary completion date in April 2029 and final study completion in June 2029.

Researchers are collecting and evaluating long-term clinical and X-ray data to better understand the safety and performance of shoulder arthroplasty over time. This observational study follows patients for at least 10 years to observe outcomes without a set limit on follow-up duration. The study includes people with various shoulder conditions such as osteoarthritis, rotator cuff tears, fractures, and infections. Participants in this study have undergone or are indicated for shoulder arthroplasty surgery. The study tracks their progress over time through regular clinical and radiographic assessments. Various outcome scores like the Constant score, ASES, Oxford Score, TESS, and MSTS are measured approximately once per year throughout the study period to evaluate shoulder function and recovery. During the study, participants will attend scheduled visits where clinical exams and imaging are performed to monitor their shoulder health and prosthesis performance. They will complete questionnaires related to their condition and function. The study aims to gather comprehensive long-term data on shoulder arthroplasty outcomes, with follow-up lasting at least 10 years from enrollment.

This research investigates whether personalized medical treatment guided by a special diagnostic procedure during invasive coronary angiography can improve symptoms, wellbeing, cardiovascular risk, and clinical outcomes in patients with angina but no significant blockage in their coronary arteries. It focuses on patients with ischaemic heart disease, particularly those with angina without obstructive coronary artery disease INOCA, a condition affecting the small vessels of the heart. The trial builds on earlier pilot studies that suggested this approach could improve quality of life and symptom control by tailoring diagnosis and treatment more precisely. Participants undergo functional coronary angiography with a guidewire-based interventional diagnostic procedure IDP that measures coronary vascular function to classify patients into specific diagnosis groups, such as microvascular or vasospastic angina. Eligible patients are randomized into two groups one where IDP results are disclosed to clinicians to guide treatment, and another where IDP is performed but results are hidden, with care based on standard angiography and clinical information. Both groups receive medical therapy and lifestyle advice based on their diagnosis. The study also includes a registry for patients with obstructive disease who are not randomized. During the study, participants complete symptom questionnaires like the Seattle Angina Questionnaire to assess their angina symptoms and quality of life over at least 12 months. Researchers monitor health status, clinical outcomes, safety, and health economics, with ongoing follow-up planned for up to 10 years. Both patients and their usual care clinicians are blinded to the group allocation, but informed about the diagnosis to guide treatment. The trial aims to enroll 1500 participants across multiple centers in Europe, assessing the feasibility and impact of this stratified medicine approach.

This research aims to collect high-quality, standardized data over time on advanced non-small cell lung cancer NSCLC patients who have a specific genetic change called METex14 skipping alterations. The study focuses on tracking treatment patterns, patient characteristics including biomarker data, and outcomes related to safety and effectiveness for those receiving systemic therapies. It is a multinational disease registry that observes patients without changing their routine care. Participants diagnosed with advanced NSCLC and harboring METex14 skipping alterations will be observed while receiving their usual systemic treatments as determined by their physicians. No treatments or procedures are imposed by the study. Data is collected from the time of enrollment and continues through routine clinical care until the participants death, loss to follow-up, enrollment in another clinical trial, or the end of the registry data collection period. During the study, participants will have their demographic and clinical information recorded, including tumor response assessments based on standardized criteria and survival outcomes. Safety is monitored by tracking any adverse events or reactions experienced. The study follows participants for up to approximately 4.9 years, gathering information about how their disease progresses and how they respond to treatments in real-world settings.

Researchers are studying breast cancer patients who have Triple Negative Breast Cancer TNBC andor a germline BRCA mutation gBRCA to see if adding olaparib, a PARP enzyme inhibitor, to platinum-based neoadjuvant chemotherapy is safe and improves the complete response rate at surgery. This is a randomized, open-label phase IIIII trial conducted in three stages, involving at least 780 patients, including 220 with gBRCA mutations. Participants receive at least 21 weeks of chemotherapy before surgery. Study groups include a control arm receiving paclitaxel and carboplatin, and two experimental arms where patients receive the same chemotherapy plus oral olaparib tablets taken twice daily during specified days of each 3-week cycle. Additional treatments such as prophylactic granulocyte-colony stimulating factor and anthracyclines are given as per local practice. Patients with residual disease after chemotherapy may join a sub-study with further treatments. During the trial, patients undergo screening tests including BRCA mutation testing, tumor marker assessments, and standard cancer staging. Researchers monitor treatment safety and effectiveness through pathological complete response rates, adverse events, survival outcomes, quality of life questionnaires, and imaging. Follow-up occurs for up to 10 years after surgery, with safety data regularly reviewed by independent committees to ensure participant well-being.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.