Seinajoki

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effect of the recombinant zoster vaccine on the risk of being newly diagnosed with dementia in adults aged 76 years or older living in Finland. This Phase IV pragmatic trial compares the vaccine to a placebo to understand its impact on dementia incidence in an older adult population. Participants will be followed for up to 10 years to monitor the occurrence of dementia diagnoses, deaths, loss to follow-up, or the end of data availability. Participants are randomly assigned in a 3:1 ratio to receive either the recombinant zoster vaccine or a placebo. Both treatments are given as two intramuscular doses: the first dose at the initial visit (Day 1) and the second dose between 2 and 6 months after the first dose, following the approved dosing schedule. This setup allows researchers to observe and compare the long-term effects of the vaccine versus placebo on new dementia diagnoses. During the study, participants will be monitored through health register data to track dementia diagnosis and related health outcomes. The main measure is the hazard ratio for new dementia diagnoses from the first dose until the earliest of dementia diagnosis, death, loss to follow-up, or study end, with assessments continuing for up to 10 years. Participants must provide informed consent and remain living in the community, as those in nursing facilities are not eligible. Safety and adherence are overseen throughout the study period.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies in this Phase 3 randomized, placebo-controlled, double-blinded trial. The study includes pregnant women aged 49 or younger between 24 and 36 weeks of gestation with uncomplicated singleton pregnancies and no major fetal abnormalities. Participants must also have documented negative tests for HIV, syphilis, and hepatitis B during this pregnancy. The goal is to learn how the vaccine works and to monitor safety for both mothers and their infants. Participants will receive one injection of either the GBS6 vaccine or a saline placebo. Pregnant women will be followed for up to 14 months, including 6 months after delivery. Their babies will be followed for about 12 months after birth. A subset of infants will also receive routine vaccinations such as diphtheria toxoid-containing vaccines and pneumococcal vaccines according to their country's immunization schedule, with blood samples collected one month after completing primary and toddler booster doses. Mothers will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious or medically attended events up to 6 months postpartum. Infants will be observed for adverse events from birth through at least one year, with serious and medically attended events tracked through 6 months. Researchers will also measure antibody levels in infants at birth to assess the vaccine's potential to protect against early and late onset GBS disease. Mothers will attend at least 3 to 4 study visits, some via telephone, to support ongoing safety and immunogenicity assessments.

Background: Non-operative management (NOM) for rectal cancer is an accepted treatment option that has not been commonly utilized in Finland but has been widely adopted in major cancer centers worldwide. NOM can be considered if the rectal tumor disappears with neoadjuvant treatment, resulting in a complete clinical response. Objective: The aim of the study is to establish a unified NOM protocol for national use and determine whether the outcomes of Finnish and Estonian treatment practices align with international experiences. Design: The study is a prospective, non-randomized, single-arm, international multicenter trial examining the oncological and quality-of-life consequences of NOM. Primary Endpoint: The primary endpoint is disease-free survival 2 years after the initiation of NOM. Secondary Endpoints: These include overall survival, disease-specific survival, survival free from total mesorectal excision (TME) surgery, survival free from circulating tumor DNA (ctDNA) detection after complete clinical response, recurrence-free survival, incidence of local recurrence and metastases, salvage TME success rate, quality of life at 1 year post-NOM, and treatment-related morbidity up to 5 years. Inclusion Criteria: Patients must have histopathologically confirmed primary rectal adenocarcinoma before neoadjuvant treatment, achieve clinical complete response (cCR) after neoadjuvant therapy, and express willingness to undergo rectum-preserving treatment after considering the risk of recurrence. Exclusion Criteria: Patients with evidence of metastasis at diagnosis, aged under 18, those not receiving neoadjuvant treatment, or those unable to provide informed consent are excluded. Diagnosis and Treatment: Pretreatment of patients follows standard practice. Upon meeting inclusion criteria with confirmed cCR, patients undergo protocolized monitoring with clinical examination, laboratory tests, and imaging. Randomization: No randomization is performed. Follow-up: Patients are monitored every 3 months for the first 2 years, then every 6 months for 3 years. Monitoring replaces surgical intervention unless cancer recurs. Follow-up is part of standard care, with costs covered by the healthcare system. Safety: Incidence of local recurrence and success of resection post-recurrence are monitored closely. If over 30% local recurrence occurs post-cCR, it may necessitate study termination at the center. Data Collection: Clinical data are entered into electronic case report forms (eCRFs) based on primary healthcare documentation and stored pseudonymized on the primary research center's server. Molecular and pseudonymized clinical data are collected securely for analysis. Sample Size Calculation and Statistical Analysis: A sample of 200 patients is estimated to provide sufficient data for the primary and key secondary endpoints and to meet other study objectives accurately. Data Handling: Data handling adheres to privacy legislation, with information stored pseudonymously.

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 each year. Many patients present with blood in the urine, which often leads to invasive bladder examinations called cystoscopies. However, only about 10% of these cystoscopies detect cancer, creating a need for better diagnostic methods. The UROSCOUT-1 trial is a prospective multicenter observational study aimed at evaluating whether urine tumor DNA (utDNA) testing can reduce the number of cystoscopies needed for patients suspected of having urothelial cancer. This study collects urine samples by mail from patients scheduled for cystoscopy to rule out urothelial cancer. The samples are then analyzed without knowing the patients' cancer status. To balance the study groups, random subsampling is used to create a roughly equal number of cancer-positive and cancer-negative patients. The goal is to see if utDNA testing can potentially replace many cystoscopies, improving patient quality of life and reducing healthcare costs and workloads. Participants will provide urine samples and undergo their scheduled cystoscopy. Researchers will measure the sensitivity and specificity of the utDNA test for detecting urothelial cancer one year after diagnosis. The study will monitor and compare test results with clinical outcomes to assess if utDNA testing can serve as a reliable alternative to cystoscopy. The participation includes sample mailing and follow-up over a year.

Researchers are comparing two treatments for intra-articular proximal tibia fractures in people over 65 years old. The study focuses on how well patients regain knee function and manage pain one year after treatment. These fractures are common in the elderly and usually treated with open reduction and internal fixation (ORIF), though this method has a high failure rate and often leads to complications like infection, poor healing, and loss of walking ability. Total knee replacement (TKR) is another option that may allow quicker recovery, but it has not been directly compared to ORIF in a randomized trial for this condition. Participants will receive either osteosynthesis using a locking plate (ORIF) or primary total knee replacement (TKR). Both treatments are surgical procedures aimed at fixing the fracture and restoring knee function. The study includes 98 patients randomized to one of these two treatment groups to evaluate their outcomes. The goal is to determine which approach leads to better knee function, less pain, and improved ability to walk and quality of life one year after treatment. During the study, patients will be assessed for knee function and pain over a 12-month period following treatment. Researchers will use measures like the Oxford knee score and other evaluations of walking ability and life quality. The study also monitors complications and recovery progress. Participants are involved in follow-up visits and assessments to track their knee health and overall recovery throughout the year after their surgery.