Seinajoki

Researchers are evaluating the effect of the recombinant zoster vaccine on the risk of developing new dementia diagnoses among adults aged 76 years or older living in Finland. This phase IV pragmatic trial aims to assess whether receiving this vaccine influences the incidence of dementia, including Alzheimers disease, over a long follow-up period. Participants will be randomly assigned to receive either the vaccine or a placebo. Participants in the vaccine group receive two doses of the recombinant zoster vaccine the first dose on Day 1 and the second dose between 2 and 6 months later, following the approved dosing schedule. Those in the placebo group receive two doses of placebo injections on the same schedule. The study is randomized, placebo-controlled, and observer-blind to compare outcomes between these two groups. During the study, participants will be followed for up to 10 years after their first dose to monitor for new dementia diagnoses, death, or loss to follow-up. Researchers will use health register data to assess outcomes including new diagnoses of dementia and Alzheimers disease. Safety monitoring includes exclusion of severely immunocompromised individuals and those living in nursing facilities. The total participation duration allows long-term observation of vaccine effects on dementia risk.

The BEATRIX study focuses on healthy pregnant women aged 49 or younger between 24 and 36 weeks of pregnancy to evaluate the safety and immune response of a group B streptococcus GBS vaccine. Researchers aim to understand how this vaccine works in pregnant women and their babies, assessing various safety measures and immune responses related to GBS. This study is a Phase 3, randomized, placebo-controlled, double-blinded trial sponsored by Pfizer. Participants will receive a single injection of either the GBS vaccine or a placebo saline. After birth, a subset of infants will receive routine vaccines according to each countrys immunization schedule, including vaccines for diphtheria, pneumococcal disease, and others. Some infants will have blood samples taken after completing their primary and toddler vaccine doses to evaluate immune responses. Pregnant participants will visit the study site at least three to four times, with some visits possibly conducted by phone, and may stay involved for up to 14 months, including six months after delivery. Their babies will be followed for about 12 months, with a subset participating for up to 19 months. Researchers will monitor local and systemic reactions, adverse events, and antibody levels in both mothers and infants to assess safety and immunogenicity of the vaccine throughout the study period.

Researchers are evaluating the outcomes of a nonoperative management approach for rectal cancer in patients who have a complete clinical response after neoadjuvant therapy. This prospective, non-randomized, single-arm international trial aims to establish a unified protocol and compare the oncological results and organ preservation rates with practices worldwide. The study focuses on disease-free survival two years after starting nonoperative management as the primary endpoint. Patients with confirmed complete clinical response after standard neoadjuvant treatment undergo nonoperative surveillance involving clinical examinations, laboratory tests, and imaging such as digital rectal exams, endoscopy, rectal MRI, and body CT scans. This single treatment arm follows a watch-and-wait approach to monitor for local regrowth or distant spread, avoiding surgery unless cancer recurs. Follow-up visits occur every three months for the first two years and every six months for the next three years. Participants will be closely monitored through clinical assessments and imaging to detect any recurrence or metastases. Researchers will measure survival outcomes, organ preservation rates, quality of life, and treatment-related complications up to five years. Data are collected securely and pseudonymously, with costs of follow-up covered by the healthcare system. The study may end at a center if local recurrence exceeds 30% after complete clinical response.

Urothelial cancers of the bladder and upper urinary tract cause significant illness and death worldwide, with over 600,000 new cases and 200,000 deaths annually. Patients often present with hematuria blood in urine, leading to many cystoscopiesan invasive bladder examination. However, only about 10% of these cystoscopies result in a cancer diagnosis. This observational study aims to evaluate whether urine tumor DNA utDNA testing can replace many cystoscopies in diagnosing urothelial cancer, potentially improving patient quality of life and reducing healthcare costs and workload in urology centers. The study involves collecting urine samples by mail, which will be analyzed without knowledge of patients cancer status. Patients scheduled for cystoscopy to rule out urothelial cancer will be included, and a random subsampling process will balance cancer-positive and cancer-negative groups. The study will follow patients to compare the sensitivity and specificity of utDNA testing against cystoscopy and urine cytology, assessing the potential to avoid invasive procedures. Participants will provide informed consent and submit urine samples by mail. Researchers will monitor outcomes such as test accuracy, time to diagnosis, adverse events related to cystoscopy, and the number of cystoscopies potentially avoided. Follow-up will extend up to 10 years to evaluate long-term diagnostic outcomes and safety. The study duration includes diagnostic workup and extended monitoring to measure the effectiveness of utDNA testing in clinical practice.

Researchers are comparing two treatments for intra-articular proximal tibia fractures in patients aged 65 and older. The study evaluates knee function and pain one year after treatment using either locking plate osteosynthesis ORIF or primary total knee replacement TKR. These fractures are common in the elderly and often come with complications like osteoporosis and risk of losing independent walking ability. The study addresses the need to compare traditional ORIF treatment with TKR as a primary option, as no randomized controlled trials have done so before. The study involves two treatment groups. One group receives osteosynthesis with locking plates through incisions based on the fractures shape, with possible use of bone transplantation and additional fixation. Post-surgery, patients follow a weight-bearing schedule starting with limited weight for six weeks. The other group undergoes total knee replacement within two weeks of fracture, using a medial parapatellar approach with prosthesis tailored for stability and bone condition. Patients in this group are allowed full weight bearing as tolerated after surgery. Participants undergo assessments at multiple points up to 10 years, including knee function, pain, physical performance, quality of life, satisfaction, and any reoperations. The main outcome measure is knee function at 12 months. Researchers will use these evaluations to compare the effects of both treatments. The study lasts for many years with follow-ups to monitor long-term results and safety.

This research aims to assess whether a virtual reality VR educational program can help nursing students improve their counseling skills for patients undergoing day surgery. Day surgery patients have limited hospital time but require thorough information about their surgery, recovery, and home care. Nurses face challenges providing effective education in such short timeframes, and traditional nursing education often lacks the emotional and patient perspective needed for real clinical situations. The study focuses on a new VR-based intervention designed to fill this gap. The intervention, called CINDY, is a 90-minute VR educational program delivered via the ThingLink platform. It includes interactive 360-degree videos that show the day surgery patient journey from admission to discharge, emphasizing patient concerns, anxiety management, and practical counseling techniques. The study compares 30 nursing students who receive this VR program alongside their standard perioperative education with 30 students who receive only standard education. This pilot feasibility study will run for about six to seven months. Participants will be assessed at three points before the intervention, immediately after, and four to six weeks later. The study collects both quantitative data on counseling skills, usability, recruitment, retention, and adherence, as well as qualitative feedback from students, educators, and nurses through interviews and focus groups. The primary goal is to evaluate the feasibility and acceptability of the VR program to inform a future larger study on its effectiveness in nursing education.