Joensuu

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had successful endoscopic removal of common bile duct stones. The study focuses on a combined outcome of death, major postoperative complications, or recurrent biliary disease within one year after randomization. The trial is designed as a randomized study involving elderly patients with specific age and health criteria. Participants are randomly assigned to either the laparoscopic cholecystectomy group or the wait-and-see group in equal numbers. The cholecystectomy procedure is performed during the same hospital stay or within two weeks after randomization. The study includes one planned interim safety analysis after 100 patients have been randomized, with the trial possibly ending early if significant differences in outcomes are detected between the two groups. During the study, researchers will monitor participants for death, major complications, or recurrent biliary events from the time of randomization up to one year. Safety and efficacy are carefully assessed to determine if the wait-and-see strategy is not worse than surgery. Participants' health status and outcomes will be tracked throughout the year following their enrollment in the trial.

Implantation of a drug-eluting stent (DES) has become a standard of percutaneous coronary intervention (PCI) during the last two decades. However there are still significant drawbacks in using DES as a permanent coronary implant. Most importantly, bleeding remains a significant complication of PCI, especially in elderly patients. The number of PCI patients having OAC:s is already significant, and will grow in the future, as the volume of PCIs in octogenarians increases, and so does the incidence of atrial fibrillation by age. After stenting at least one month lasting dual antiplatlet treatment (DAPT) is mandatory, and it cannot be safely terminated in case of a bleed. The optimal duration of DAPT on patients at bleeding risk is not known. Balloon coated with paclitaxel and iopromide (drug-coated balloon, DCB) was originally developed for the treatment of in-stent restenosis, but later its potential for the treatment of de-novo coronary artery leasons has become clear in large registry trials. So far, the randomized controlled studies have shown the non-inferiority of PCI using DCB in comparison to DES in de novo leasons in small vessels. Also the non-inferiority of PCI using DCB in comparison to BMS was shown in the DEBUT trial in large vessels on patients at high bleeding risk. These results need to be confirmed in comparison of DCB to DES as the use of BMS is diminishing. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients on anticoagulation medication or otherwise on high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.

Endometriosis is a chronic condition where tissue similar to the lining inside the uterus grows outside it, causing pain and fertility problems in many women of reproductive age. This research aims to find new diagnostic tools and treatments by studying specific RNA and protein expressions in endometriosis and healthy tissues. The study will also record different pain symptoms yearly and follow participants for 10 years to understand infertility, disease progression, and recurrence better. Participants will undergo surgical procedures such as laparoscopy or laparotomy to treat endometriosis or for sterilization purposes, during which tissue samples will be collected for detailed analysis. The study compares patients with verified endometriosis to a control group without the condition based on laparoscopic examination. These samples will help identify new targets for therapies and biomarkers. Throughout the study, researchers will analyze tissue hormone metabolism, serum markers, and gene expression during surgery. They will collect data via questionnaires over ten years, tracking fertility, treatments received, and pain symptoms using numeric rating scales. This long-term follow-up aims to find markers predicting infertility and disease course while monitoring safety and treatment outcomes.

Acute bronchiolitis is a common reason for hospitalization in infants under one year old, mainly caused by the respiratory syncytial virus (RS-virus). This research compares two ways to stop high flow nasal cannula treatment, which helps infants breathe better. The study aims to find out if stopping the treatment immediately shortens hospital stays and if this approach is safe, compared to gradually reducing the flow rate over time. The study involves two approaches: one group stops high flow nasal cannula therapy at once, while the other group has the flow rate slowly decreased. The high flow nasal cannula is usually set at a flow rate of up to 2 liters per kilogram per minute. The trial examines the use of these two methods in infants with acute bronchiolitis who have been on high flow treatment for at least 12 hours with good oxygen levels. Participants will be monitored for their hospital stay duration after randomization for one week. They will be assessed based on oxygen saturation levels and suitability to stop high flow therapy as determined by their doctors. The study measures how long infants remain hospitalized after stopping treatment immediately or through gradual weaning, focusing on safety and effectiveness of both strategies.

Researchers are studying the sexual function and quality of life in women who undergo a loop electrosurgical excision procedure (LEEP) due to HPV-related cervical lesions. This prospective multi-center study aims to determine if LEEP affects sexual function or health-related quality of life compared to women who only have colposcopy visits without LEEP. The study involves women aged 18 to 70 years who are referred for cytological changes or repeated HPV positivity and have not previously undergone LEEP or similar cervical operations. Participants will be divided into two groups: those receiving LEEP as treatment and those receiving only colposcopy as a control. The LEEP procedure involves removing the affected cervical area using a small electrically charged loop under local anesthesia. Women will complete self-report questionnaires assessing sexual function using the Female Sexual Function Index (FSFI) and quality of life using the 15D questionnaire at their first colposcopy visit and at 6 months, 24 months, 3 years, and 5 years after the initial visit. During the study, participants are contacted five times to complete web-based questionnaires and provide background information without needing extra visits or sample collections. The research team will compare the groups' questionnaire scores over time to evaluate any differences in sexual function and quality of life. All data is securely managed and stored, with patient confidentiality maintained throughout the study period, which lasts up to five years after enrollment.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.