Jyvaskyla

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 comparing two treatment approaches for patients with acute atrial fibrillation or flutter who need rhythm control. The study focuses on whether these irregular heart rhythms can be safely managed with elective treatment within 5 to 9 days. Patients are recruited from the emergency department and must be healthy enough to be discharged regardless of their assigned treatment. One group receives conventional care with immediate rhythm control using medical or electrical cardioversion in the emergency department within 48 hours of arrhythmia onset. The other group is treated electively, discharged after temporary rhythm control, and if still in arrhythmia one week later, undergo cardioversion at an outpatient cardiology clinic. All patients receive anticoagulation according to guidelines, including pre-treatment before delayed cardioversion if applicable, with additional heart ultrasound screening when needed. Patients in the elective group can opt for immediate cardioversion if symptoms worsen. Participants complete quality-of-life questionnaires and are monitored for symptoms and any urgent medical needs during the first week and one month after the outpatient visit. At one month, an ECG is performed to check for normal heart rhythm maintenance. After this, patients are followed up for up to five years to track any further treatments required for atrial fibrillation or flutter. New antiarrhythmic drugs are not used during the first month.

Researchers are studying adolescent depression by examining how young people with depressive symptoms access mental health services and respond to different treatments. This observational cohort study focuses on Finnish adolescents in grades 7 to 9 (ages 13 to 16) without prior depression treatment. The study aims to understand if adolescents have equal access to care and how to best identify those who could benefit from adolescent interpersonal counseling (IPC-A), a newer, shorter form of therapy adapted from interpersonal psychotherapy. Participants will be grouped based on treatment received: IPC-A, treatment as usual (other behavioral or medical support), or no treatment. IPC-A involves 3 to 8 brief individual sessions focusing on interpersonal relationships to prevent or treat mild to moderate depression. Researchers will follow participants over 6 months through surveys completed by adolescents and caretakers, collecting data on depressive symptoms, treatment needs, received care, motivation, and treatment effects. Information from therapists and health records will describe treatment content and frequency, and register data will be used to analyze service use and costs from one year before baseline up to 10 years after. Throughout the study, adolescents will complete surveys on risk and protective factors for depression three times in 6 months and report depressive symptoms every two weeks. Caretakers will provide their perspectives through two surveys during the same period. The main outcome is the proportion of adolescents referred to specialized psychiatric services within 12 months. Secondary measures include the proportion receiving any support, changes in depression scores, and cost-effectiveness. The study's findings aim to improve access to care, treatment detection, and inform best practices for adolescent depression.

Researchers are investigating better ways to detect significant prostate cancer in men who are suspected of having the disease. The study compares two approaches: one where all men receive prostate biopsies after a pre-biopsy MRI scan, and another where biopsies are done only after a shared decision between the patient and urologist based on a risk estimate for prostate cancer. The trial involves 600 men and focuses on detecting clinically significant prostate cancer, defined as Gleason 4+3 or higher, at baseline. Participants are randomly assigned to one of two groups. In the control group, all men undergo prostate biopsies after an MRI scan. In the intervention group, biopsies are performed only after shared decision-making that considers prostate cancer risk factors such as age, medication use, PSA levels, MRI findings, and prostate volume. The MRI scans are evaluated by experienced radiologists using specific classification systems. Men with negative or no biopsies enter a five-year follow-up with PSA testing every six months. During the study, participants undergo MRI scans and discussions with their urologist about biopsy decisions. Those without significant findings are monitored with regular PSA tests for five years, followed by long-term health record tracking for 15 more years. The main outcome measured is the proportion of men diagnosed with clinically significant prostate cancer at the study's start. Safety and patient status are closely monitored throughout the trial.

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.

Researchers are evaluating whether adding azithromycin to the standard antibiotic cefuroxime before hysterectomy surgery can reduce the risk of deep infections occurring within 30 days after the procedure. The study focuses on women undergoing hysterectomy for non-cancerous reasons and aims to lower the approximately 5% infection risk that can cause personal health burdens and financial costs. It also explores if bacterial vaginosis and changes in the microbiome affect post-surgery infections. Participants receive either azithromycin pills plus cefuroxime or placebo pills plus cefuroxime before surgery. Azithromycin is given orally as two 500 mg tablets upon hospital arrival, and cefuroxime is given as a single dose in the operating room, with the dose adjusted based on body mass index. The placebo group receives identical tablets without azithromycin alongside the cefuroxime dose. The treatments are administered before the surgical incision. Throughout the 30-day post-hysterectomy period, researchers monitor participants for deep infections and other complications like superficial infections, urinary tract infections, and fever. They also assess any side effects from the antibiotics. The main outcome measured is the number of deep infections occurring between the first and 30th day after surgery, with ongoing safety checks and bacterial evaluations to understand infection causes and treatment effects.

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.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Carpal tunnel syndrome is a common condition causing pain, numbness, and tingling in the fingers, often worse at night. This trial evaluates the effects of night-time and full-time wrist splinting compared to no treatment in people with carpal tunnel syndrome. It also aims to find which groups might benefit most from splinting and whether responding well to splinting reduces the need for surgery. Participants will use a neutral-positioned wrist splint. Each person will go through three treatment periods in random order: wearing the splint only at night for six weeks, wearing the splint both day and night for six weeks, and a six-week period with no treatment. These periods are separated by three-week breaks, resulting in a total treatment sequence of 24 weeks. Participants will also receive instructions for self-administered stretching exercises and are asked to avoid other medical treatments for this condition during the study. During the trial, participants will complete electronic self-report questionnaires to measure their symptoms, focusing on changes in a six-item symptom scale over six weeks. The study will follow participants for up to one year after starting. Monitoring includes assessing symptom changes after each treatment period, adherence to exercises, and avoiding other therapies to understand the splinting effects.

Researchers are evaluating the effects of three different treatments on major adverse kidney events (MAKE) in adults who are unconscious after being resuscitated from out-of-hospital cardiac arrest. This sub-study is part of the larger STEPCARE trial and involves 3,500 participants. The study focuses on kidney-related outcomes, including death within 30 days, need for kidney replacement therapy, and kidney function changes measured by creatinine levels at hospital discharge. The main trial randomly assigns patients to one of three treatments: continuous deep sedation for 36 hours versus minimal sedation; fever control using a feedback-controlled device if body temperature rises above 37.7°C versus fever control without a device; and two blood pressure targets with mean arterial pressure (MAP) set to either ≥65 mmHg or ≥85 mmHg maintained by vasopressors for 36 hours. The feedback-controlled temperature device is set to maintain temperature at 37.5°C when used. Participants will be closely monitored during their hospital stay with data collected prospectively according to the main trial protocol. Researchers will assess major adverse kidney events within 30 days and examine creatinine changes during the hospital stay and within 72 hours after resuscitation. The study aims to understand how these treatments affect kidney outcomes after cardiac arrest, with analyses following a predefined statistical plan.