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 prospective, observational registry includes patients who have undergone percutaneous coronary intervention (PCI) using this stent and are planned for a short dual antiplatelet therapy (DAPT) regimen lasting up to 3 months. The aim is to assess clinical outcomes in a real-world population across multiple countries and centers. Participants receive the Vivo ISAR stent and follow standard care with a short DAPT treatment of no more than 3 months after PCI. The study does not influence the choice of device or treatment beyond routine care. After the procedure, patients who meet eligibility criteria and provide consent are enrolled and observed over time without additional interventions. Participants will be followed up through routine clinical practice and telephone calls at 30 days, 3 months, and 12 months after PCI. These follow-ups collect information on ongoing medications, any lab tests performed, adverse events, and any further interventions. The main outcomes measured at 12 months include ischemic events and bleeding events related to the treatment and stent use.

Researchers are evaluating KT-621, an oral drug, in adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b study aims to assess the safety, tolerability, and how well KT-621 works in treating this condition. The study also looks at how KT-621 behaves in the body to better understand its effects. Participants will receive either KT-621 or a matching oral placebo in a randomized, double-blind, placebo-controlled design. The study focuses on assessing various doses to find the most effective and safe amount. Treatment effects will be measured over 12 weeks to observe changes in lung function and asthma control. During the study, participants will undergo regular visits including lung function tests (pre-bronchodilator FEV1), asthma control questionnaires, and blood tests to monitor eosinophil levels. Researchers will track participants’ adherence through electronic diaries and assess safety throughout the study. The main outcome is the change in lung function from baseline to Week 12, with continuous monitoring to ensure participant safety and study integrity.

This research aims to collect daily urine samples from women who are actively trying to conceive to maintain the SPD Biobank. The study includes cycles where conception occurs and those where it does not, along with related information such as menstrual days, participant age, and reproductive hormone levels. Volunteers will use a Clearblue Ovulation product to identify their most fertile days as part of the study. Participants will receive the ovulation test and are asked to collect daily early morning urine samples throughout the study period. They will keep a daily diary documenting menstrual cycles, sample collection, and pregnancy test results. The study lasts up to three consecutive menstrual cycles if pregnancy does not occur or up to day 60 of pregnancy if conception happens. Urine samples will be sent to a clinical laboratory for hormone testing related to pregnancy and fertility, then stored at -80°C in the SPD Biobank for future product development and evaluation. Researchers will monitor participants' pregnancy status and sample collection during the study, which continues until pregnancy confirmation or the start of the next menstrual cycle, with a maximum duration of three cycles if pregnancy does not occur.

This research aims to gather real-world information on using intravascular lithotripsy (IVL) with the Shockwave IVL system to treat calcified lesions in the femoropopliteal and crural arteries of patients with chronic limb-threatening ischemia (CLTI). The main goal is to understand how effective IVL is in helping wounds heal and avoiding amputations. The study also looks at how well the treatment restores blood flow immediately, its safety, and its effect on patients' quality of life. Participants receive treatment with the Shockwave Medical IVL System, a comprehensive device that includes a generator, connector cable, and a single-use catheter with an integrated balloon designed to break up artery calcification. The study is observational and collects data on patients who undergo this treatment for their calcified arterial lesions. During the study, researchers will monitor wound healing and whether participants avoid amputation over 12 months. They will also assess how well the blood vessels open after treatment and track safety and quality of life outcomes. Participants will be followed to collect this information over the course of a year to understand the impacts of IVL treatment for CLTI.

Researchers are collecting and evaluating long-term data on clinical and radiographic outcomes to better understand the safety and performance of shoulder arthroplasty over time. This study includes people with various shoulder conditions such as osteoarthritis, osteonecrosis, rotator cuff tears, rheumatoid arthritis, fractures, and infections. The trial will follow participants for at least 10 years, with no early limit on follow-up duration. The study includes patients who are either scheduled for shoulder arthroplasty or have already undergone the procedure. Participants must be skeletally mature and expected to survive at least two years beyond surgery. The study is open-label and multi-center, involving both retrospective and prospective data collection. There are no specific interventions or treatments being compared, as the focus is on observing outcomes after shoulder arthroplasty. Participants will undergo assessments including clinical and radiographic evaluations at an average of once per year throughout the study. Outcome measures include the Constant score, ASES (American Shoulder and Elbow Surgeons) score, Oxford Score (optional in the UK), TESS, and MSTS scores related to pre-operative conditions. Researchers will monitor participants for safety and implant performance during the long-term follow-up, which can last a minimum of 10 years.

Researchers are studying patients with known or suspected angina who do not have obstructive coronary artery disease to see if a special diagnostic test can help guide personalized treatment. This condition includes ischaemic heart disease, microvascular angina, and vasospastic angina. The trial builds on earlier research suggesting that tailoring treatment based on coronary vascular function tests may improve symptoms and quality of life. This large, multicentre, blinded, randomized study aims to confirm these findings and assess effects on health and wellbeing over a longer period. Participants undergo invasive coronary angiography along with an adjunctive interventional diagnostic procedure (IDP) that measures coronary vascular function using a guidewire technique. Patients with no significant artery blockage are randomized into two groups: one where IDP results are disclosed to guide treatment decisions, and a control group with concealed results receiving standard care. Those with abnormal vascular function in the intervention group may have repeated assessments to tailor medications, such as calcium channel blockers. Patients with obstructive artery disease or other exclusions may join a registry for follow-up and assessment. Throughout the study, participants complete questionnaires about angina symptoms, quality of life, activity levels, treatment satisfaction, and pain. Researchers monitor clinical outcomes for at least 12 months, including major cardiovascular events. The study also evaluates the safety and usefulness of the diagnostic procedure in multiple hospitals across Europe. Blood samples are collected to explore disease mechanisms. Participants and their doctors remain blinded to group assignments, but diagnoses are shared to help guide care following current guidelines.

Researchers are collecting detailed, real-world information over time about people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called METex14 skipping alteration. This study aims to understand how treatments for this type of lung cancer are used and how well they work and how safe they are in everyday clinical practice across multiple countries. It is a disease registry that observes patients without changing their treatment plans. Participants in this registry will continue to receive their usual cancer treatments as decided by their doctors, with no additional procedures or therapies imposed by the study. The registry gathers data on each participant's demographics, clinical features including biomarker information, treatment patterns, and outcomes related to effectiveness and safety. The study is non-interventional, meaning treatments are not assigned by the study but follow routine clinical care. Throughout the study, researchers will monitor and record best overall tumor response, tumor response using standard criteria (RECIST 1.1), overall survival, and the number of participants experiencing adverse events or reactions. This data collection will continue for up to approximately 4.9 years, enabling long-term follow-up of outcomes and safety in this patient population.

Researchers are investigating the effects of a three-week music intervention on brain reorganization and arm function in people who have upper limb weakness following a stroke. This study focuses on understanding the neuroplastic changes caused by Therapeutic Instrumental Music Performance (TIMP) and how it may improve arm and hand function. Five participants who have completed their community stroke rehabilitation will take part in this single-arm pre-/post experiment. Participants will receive 15 music therapy sessions over three weeks, conducted in their homes by trained clinicians including music therapists and stroke rehabilitation specialists. The intervention uses various percussion instruments, an iPad with touchscreen instruments, and exercises designed to promote full arm movement. The sessions progress in difficulty to increase movement range, frequency, and complexity without compromising exercise quality. Participants will undergo assessments before and after the intervention, including EEG recordings to measure brain activity, arm function tests such as the Action Research Arm Test and nine-hole peg test, and quality of life questionnaires. EEG measurements will capture brain wave changes during rest, tapping tasks, and working memory tasks. Data will be collected at baseline and at weeks 1, 4, 7, and 10 to evaluate changes. Safety and consent will be carefully monitored throughout the study, with participants able to withdraw at any time.

Researchers are investigating the safety and effectiveness of adding olaparib, a PARP enzyme inhibitor, to platinum-based chemotherapy given before surgery in patients with triple-negative breast cancer (TNBC) and/or those with germline BRCA (gBRCA) mutations. This randomized phase II/III trial aims to see if this combined treatment improves the rate of pathological complete response (pCR) at surgery while monitoring safety outcomes. The study plans to enroll at least 780 patients, including a minimum of 220 with gBRCA mutations. Participants will receive a minimum of 21 weeks of chemotherapy followed by surgery. The treatment includes oral olaparib tablets taken twice daily about 12 hours apart, alongside intravenous paclitaxel and carboplatin given in cycles every three weeks. During the trial, standard supportive care like granulocyte-colony stimulating factor and anthracyclines may also be administered. For those with residual disease after initial treatment, there is an option to join a sub-study involving additional chemotherapy drugs. Throughout the study, patients will undergo screenings including BRCA mutation testing and various tumor marker assessments. Safety will be closely monitored by the trial team and an independent committee. The main outcomes measured are treatment-related side effects, pCR rates after surgery, and long-term efficacy assessed over approximately 5.5 years, with follow-up planned for up to 10 years after surgery.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.