Tiwi

Researchers are studying the prevalence, risk factors, and effects of chronic post-surgical pain in children aged 0 to 16 years undergoing common pediatric surgeries such as laparoscopic appendicectomy, scrotal exploration, orchidopexy, hypospadias repair, and circumcision. The study aims to understand how factors like parent and child anxiety, existing pain, and acute post-operative care relate to the development of chronic pain over time. This knowledge will help improve care and reduce the risk of long-term pain in children after surgery. The study involves completing questionnaires at six different times, starting before surgery, then at Day 2, 3-4 weeks, 3-4 months, and finally 10-12 months post-surgery. These questionnaires assess pain levels, function, and related factors. The study is conducted across multiple international centers and focuses on both elective and emergency surgeries. Participants will be involved in providing information through these questionnaires over about one year. Researchers will measure outcomes like the presence of chronic pain 10-12 months after surgery. The study will also monitor the impact of chronic pain on children's quality of life, emotional well-being, and social functioning. Families unable to complete follow-up surveys or those with language barriers may not participate, ensuring accurate and complete data collection.

Researchers are evaluating the effectiveness of icotrokinra (JNJ-77242113) compared to a placebo in adults with active psoriatic arthritis (PsA). This study includes both participants who have previously used biologic treatments and those who have not. The goal is to assess how well the drug reduces the signs and symptoms of PsA by the 16th week of treatment. This is a Phase 3, multicenter, randomized, double-blind clinical trial designed to provide reliable evidence on the drug's impact on this condition. Participants will receive either icotrokinra or a placebo. The treatments will be administered according to the study protocol, but specific dosing details are not provided. Participants will be monitored over 16 weeks to evaluate their response to the treatment, focusing on the American College of Rheumatology (ACR) 20 response, which measures improvement in disease activity. The study compares the active drug against placebo to determine its efficacy and safety in this patient group. During the study, participants will undergo assessments to monitor their psoriatic arthritis symptoms, including joint swelling and tenderness, as well as blood tests to measure inflammation markers like C-reactive protein. Female participants who can become pregnant will have pregnancy tests before and during the study to ensure safety. Researchers will collect data on disease activity and safety throughout the study period to understand the treatment's effects. Total participation time and additional follow-up details are not specified.

Researchers are evaluating the effects of epoetin alfa compared to a placebo in critically ill trauma patients who require mechanical ventilation. This phase III, randomized, double-blind trial aims to reduce death and severe disability six months after injury. The study will enroll 2,500 patients admitted to intensive care units (ICUs) with a primary trauma diagnosis in locations including Australia, New Zealand, Europe, and Saudi Arabia. Trauma can cause serious injuries that may lead to death or long-term disability despite current treatments, and epoetin alfa, a hormone stimulating red blood cell production, may have protective effects beyond this role. Participants will be randomly assigned to receive either epoetin alfa 40,000 IU via a subcutaneous injection or a placebo injection of sodium chloride 0.9%, both given as 1 mL pre-filled syringes. The treatment will be administered during the ICU stay following admission for trauma. The study monitors patients from the time of injury through ICU care and up to six months afterward to assess outcomes. During the study, patients will be closely monitored for survival and disability levels using the WHODAS 2.0 scale at six months after injury. Researchers will track various health parameters, including the severity of disability or death. The study includes detailed assessments during ICU care and a follow-up period to measure the combined proportion of patients who die or experience severe disability. Safety and response to treatment will be carefully evaluated throughout the trial period.

Researchers are evaluating the effectiveness and safety of combining ribociclib with standard adjuvant endocrine therapy (ET) in patients with hormone receptor-positive (HR+), HER2-negative early breast cancer. This study focuses on patients with Anatomic Stage Group III, IIB, and certain cases of Stage IIA breast cancer. It is a phase IIIb, open-label, multicenter, single-arm trial aiming to measure invasive breast cancer-free survival over three years. Participants who complete screening will receive ribociclib at 400 mg orally once daily for 21 days followed by 7 days off, in 28-day cycles, alongside daily endocrine therapy for 36 months, roughly 39 cycles. Endocrine therapies may include letrozole, anastrozole, exemestane, or hormone-suppressing drugs like goserelin or leuprolide, administered as per standard dosing schedules. After treatment, there is a 30-day safety follow-up and a longer follow-up period lasting until death, withdrawal, loss to follow-up, or up to 48 months after the last participant's first dose. During the study, participants will be monitored for safety and treatment efficacy through regular assessments including heart monitoring via ECG, performance status checks, and laboratory tests to ensure organ function. The main outcome is the rate of invasive breast cancer-free survival at three years. Safety follow-up calls occur 30 days after the last treatment dose, and participants are followed long-term to observe any disease recurrence or other health outcomes.

Researchers are investigating treatments for bloodstream infections caused by the bacterium Staphylococcus aureus, which can be deadly within three months of infection. This international, multi-center Phase 4 adaptive platform trial evaluates multiple treatment options simultaneously to identify those that reduce death rates within 90 days of infection. The trial adapts over time by assigning more patients to better-performing treatments, removing less effective ones, and adding new options, aiming to find the best combination of therapies for patients with this serious infection. Participants receive various antibiotic treatments such as Cefazolin, Penicillin, Clindamycin, Vancomycin or Daptomycin, as well as strategies like early switching to oral antibiotics. The trial also includes whole body FDG PET/CT imaging using standardized protocols to support diagnosis and treatment decisions. Patients are randomly assigned to different concurrent treatment options currently used in routine care, with ongoing adjustments based on accumulating results. During the study, participants undergo regular evaluations including blood culture monitoring to confirm infection clearance, clinical assessments, and imaging when applicable. Researchers track all-cause mortality up to 90 days after enrollment as the primary outcome. The trial infrastructure supports additional sub-studies, with patient safety and treatment effectiveness closely monitored throughout the trial period.

Aortic stenosis (AS) affects a significant portion of the elderly population, with approximately 5% of those over 65 years old and around 3% of those over 75 years having moderate to severe AS. The number of people with AS is increasing rapidly due to an aging population, creating challenges for clinicians in managing mostly elderly patients who are often symptom-free but have severe AS diagnosed incidentally. While symptomatic severe AS requires aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI), the best approach for asymptomatic patients remains unclear. This trial aims to compare early AVR or TAVI with standard expectant management in these patients to provide evidence on clinical outcomes and cost-effectiveness. The study is a large, multi-center randomized controlled trial conducted in the UK, Australia, and New Zealand, with plans to expand internationally. It includes two phases: a vanguard phase and a main phase, with an internal pilot to ensure adequate recruitment over two years. Eligible participants with severe asymptomatic AS will be randomly assigned to either early AVR or ongoing surveillance (expectant management). Those in the early AVR group will undergo surgery within about three months, which may include additional procedures like coronary angiography and possible coronary interventions if needed. The trial uses intention-to-treat analysis to compare outcomes between groups. Participants will be closely monitored throughout the study, with evaluations including routine tests and assessments as part of their care. The primary outcome measured is a combination of cardiovascular death and hospitalization for heart failure over a minimum of three years. The study also collaborates with another trial, EVoLVeD, offering participants additional research opportunities. Overall, the study seeks to provide important data on whether early valve replacement before symptoms develop can improve outcomes for people with severe asymptomatic AS.