Dorchester

This research aims to evaluate the performance and safety of the HARMONIC 700 Shears device when used according to its instructions in both pediatric and adult surgical procedures. The study includes pediatric general surgeries and adult general, gynecological, urological, and thoracic surgeries. It is designed as a prospective, single-arm, multi-center observational study to collect data in a real-world post-market setting. During the study, surgeons will use the HARMONIC 700 Shears device following their standard surgical methods and the devices instructions for use. The study will capture data from these procedures without additional interventions beyond necessary clinical care. Participants include children under 18 undergoing non-emergency surgeries and adults undergoing elective surgeries, with at least one vessel transection performed using the device. Participants will be monitored from the time of surgery through hospital discharge and again about 28 days afterwards. Researchers will assess the success of vessel sealing during surgery and track any device-related adverse events for up to approximately one year and seven months. The main outcomes include the number of vessel transections achieving a certain level of hemostasis and safety events related to the device.

Researchers are evaluating the safety of maribavir in adults who have severe chronic kidney disease CKD or end-stage renal disease ESRD, including those on dialysis, and who have a refractory cytomegalovirus CMV infection after transplantation. This observational study collects already existing data from participants medical records without changing their standard medical care or treatment. The study includes adults aged 18 years or older who have undergone solid organ or stem cell transplantation and have been treated with maribavir for refractory CMV infection. Data will be collected from the start of maribavir treatment through up to seven days after the last dose or until death or end of available data, whichever comes first. Participants include those with severe CKD or ESRD, including those on peritoneal or hemodialysis. Participants medical records will be reviewed to monitor any adverse events from maribavir treatment during the study period, which can last up to four years. The main measurement is the number of participants experiencing adverse events, including those of special interest. This review will not affect participants usual care, and no new treatments or interventions will be given as part of this study.

Researchers are evaluating the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy in adults with untreated, unresectable, or metastatic colorectal cancer. This study focuses on participants who have not received prior treatment and aims to provide important information about these treatment combinations in this serious cancer type. The study is a randomized, double-blind Phase 23 trial sponsored by Bristol-Myers Squibb. Participants will receive either pumitamig or bevacizumab along with one of several chemotherapy regimens, including FOLFOX, FOLFIRI, or CAPOX. The treatments are given in specified doses on scheduled days. The study includes multiple experimental and comparator arms, with participants randomly assigned to one of these groups. This design allows comparison of the different drug combinations over the course of the trial. During the study, participants will be regularly evaluated using imaging and clinical assessments to measure tumor response by RECIST criteria and other key outcomes such as progression-free survival and overall survival. These assessments will continue for up to five years to monitor treatment effects and safety. The study will also track the duration and timing of tumor responses. Participants will have visits for evaluations and safety monitoring throughout the trial period.

Researchers are evaluating the long-term safety and tolerability of pelacarsen TQJ230 in adults with established cardiovascular disease and elevated Lipoproteina who have completed a prior double-blind study. This open-label extension study follows participants from the parent trial CTQJ230A12301 to continue monitoring the effects of pelacarsen over an extended period. Participants will receive pelacarsen 80 mg once a month by subcutaneous injection during the open-label extension. This single-arm, multicenter study lasts up to 36 months, providing continued access to the study drug for those who completed the parent trial while still on the investigational product. During the study, participants will be regularly assessed for adverse events and cardiovascular outcomes, including major cardiovascular events tracked from both the parent study baseline and the extension study baseline. Lipoproteina levels will be measured at multiple time points to monitor changes over the course of the study. Safety and tolerability data will be collected up to 36 months, with ongoing monitoring by the research team throughout the study duration.

Researchers are conducting a combined phase 2b and phase 3 study to evaluate the drug CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing dialysis. The study focuses on participants with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. The trial aims to find the best dose of CSL300 and then assess its effects on cardiovascular outcomes and safety compared to a placebo. The study is divided into two parts Part 1 phase 2b is a dose-finding phase where different doses of CSL300 are given intravenously to participants to determine the optimal dose versus placebo. Part 2 phase 3 evaluates the efficacy and safety of the selected CSL300 dose compared to placebo over approximately five years. All treatments are administered by intravenous infusion. Participants will be involved in regular assessments including blood tests to measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events tracking, and monitoring for adverse events. The phase 2b portion includes up to 24 weeks of follow-up for dose evaluation, while the phase 3 portion monitors cardiovascular outcomes like heart attacks or cardiovascular death over about five years. Safety and drug levels in the blood will also be closely observed throughout the study.

Researchers are evaluating the effects of the medicine BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. This study includes people with or without type 2 diabetes and those who may or may not be taking certain blood pressure medicines such as ACE inhibitors or ARBs. The goal is to understand if adding BI 690517 to empagliflozin helps reduce the risk of kidney failure, heart disease, or hospitalization due to heart failure. The study has two parts. In the first part, all participants receive empagliflozin or a placebo similar to BI 690517 for at least six weeks while continuing any indicated ACEi or ARB treatments. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the remainder of the study. The study lasts about three to four years until enough events related to kidney or heart health occur. During the study, participants visit the study site about four times in the first six months and then every six months afterward. At these visits, doctors check health status, collect blood and urine samples, measure blood pressure and weight, assess kidney function, and monitor any side effects. Researchers track the time until worsening kidney disease, heart failure hospitalizations, or cardiovascular death to compare outcomes between treatment groups.

Researchers are evaluating the safety and effectiveness of the Shockwave Reducer device in treating patients with refractory angina pectoris who have persistent symptoms despite maximum medical therapy and cannot undergo revascularization. The study focuses on those with reversible myocardial ischemia in the left coronary artery and includes a non-randomized registry for certain patients with issues in the right coronary artery, no obstructive coronary disease, or mobility limitations. This is a multicenter, randomized, double-blinded, sham-controlled clinical trial. Participants are randomly assigned in a 11 ratio to either receive the Shockwave Reducer implant or undergo a sham implantation procedure without the device. A third unblinded, non-randomized registry arm includes patients meeting specific criteria with reversible ischemia but not eligible for randomization. The study includes follow-up over six months to assess safety and effectiveness outcomes, including angina severity measured by the Canadian Cardiovascular Society CCS Angina Score. During the trial, participants will undergo evaluations to confirm eligibility and monitor heart function, ischemia, and symptoms using tests such as stress echocardiography, nuclear studies, or exercise tolerance tests. Researchers will review co-primary effectiveness and safety endpoints at six months. Patients are expected to maintain stable medication regimens and comply with follow-up visits to help assess the devices impact on angina symptoms and heart performance.

Researchers are studying patients with chronic lymphocytic leukaemia CLL who have been treated with acalabrutinib in the United Kingdom. This observational study aims to describe the characteristics and real-world clinical outcomes of these patients, especially those who started acalabrutinib treatment as part of the UK Early Access Programme. The study seeks to provide UK-specific data on how patients respond to and tolerate acalabrutinib in typical clinical settings. The study involves reviewing clinical records of treatment-naefve CLL patients who began acalabrutinib between April 1, 2020, and April 1, 2021. The focus is on patients treated in the first-line setting with acalabrutinib under the Early Access Programme. This non-interventional study does not involve new treatments but collects and analyzes existing data to estimate progression-free survival, overall survival, response rates, treatment patterns, and healthcare resource use. Participants medical information will be gathered from their clinical records following local laws. Researchers will track outcomes such as progression-free survival at various time points up to 60 months, overall survival, response rates, and treatment interruptions. The study design allows for long-term observation of how patients fare with acalabrutinib, providing valuable real-world evidence. The study is expected to continue through April 2027.

This research aims to evaluate the effects of lowering blood phosphate levels in adults with end-stage kidney disease ESKD who are receiving dialysis. Elevated phosphate levels are common in ESKD and linked to higher risk of death and heart problems, but it is unclear if reducing phosphate improves important patient outcomes. The study will compare intensive lowering of phosphate to a more liberal phosphate target to see if this reduces heart-related deaths and events, improves physical health, and is cost-effective. Participants will be randomly assigned to one of two groups one aiming for a liberal serum phosphate target of 2.0 to 2.5 mmolL, and the other aiming for an intensive target of 1.50 mmolL or lower. Doctors will decide the type and dose of phosphate-lowering medications to help participants reach their assigned phosphate levels, following usual local practices. The study will last up to five years and is conducted internationally with 3600 adults on dialysis. During the study, researchers will monitor participants for major heart-related events and deaths, physical health, fatigue, quality of life, patient satisfaction, and itching. Regular assessments will include measuring time to cardiovascular death or major cardiovascular events and evaluating overall survival and quality of life using the EQ5D-5L tool. The study will also assess cost-effectiveness and continue to observe participants for five years to collect comprehensive data on these outcomes.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.