Jyvaskyla

Researchers are evaluating two treatment approaches for patients with acute atrial fibrillation or atrial flutter when rhythm control is desired. The study compares conventional acute cardioversion performed within 48 hours in the emergency department to elective delayed cardioversion performed approximately one week later in an out-patient clinic. The goal is to see if these arrhythmias can be safely managed with an elective timing approach. Participants are randomly assigned to either immediate cardioversion in the emergency department or to an elective delayed cardioversion after discharge. All patients receive anticoagulation treatment according to guidelines, with extra precautions such as transesophageal cardiac ultrasound if needed before delayed cardioversion. Patients in the elective group can choose early cardioversion if symptoms become unmanageable before the scheduled out-patient visit. Participants undergo follow-up visits including a cardiologist assessment about one week after enrollment and further assessments one month later with an ECG to check heart rhythm. Quality of life and symptom monitoring occur during the first week and one month after the clinic visit. Patients are then followed up for up to five years to monitor any medical interventions related to atrial fibrillation or flutter. New antiarrhythmic drugs like flecainide are not used during the first month.

Researchers are conducting a prospective observational cohort study in Finland to evaluate adolescent depression treatment pathways in primary care. The study focuses on adolescents aged 13 to 16 years attending grades 7 to 9 in selected schools, aiming to understand access to treatment and identify those who may benefit from adolescent interpersonal counseling IPC-A. The study compares IPC-A, a brief behavioral intervention, to treatment as usual and no treatment, assessing effectiveness and cost-effectiveness. The study involves adolescents completing surveys over six months about depressive symptoms, treatment motivation, and benefits or harms from treatment every two weeks. Caretakers will also provide information on adolescent support needs and treatment outcomes through surveys at six-month intervals. When applicable, professionals providing support will report on their training and treatment content. Register data on social welfare and health care service use will be collected from one year before to up to ten years after the study to inform cost and service provision. Participants will be followed for 12 months to measure outcomes including the proportion referred to specialized psychiatric services and changes in depression symptom scores. Data on received support and treatment response will be gathered from adolescents, caretakers, professionals, and patient records. The study will monitor benefits and harms of treatment, aiming to improve detection, equal access, and inform prevention strategies for adolescent depression.

This research focuses on men suspected of having prostate cancer and aims to compare two approaches for deciding when to perform prostate biopsies after MRI scans. The study evaluates whether biopsies guided by shared decision-making based on prostate cancer risk estimation differ in detecting significant cancer compared to biopsies performed routinely after MRI. Researchers seek to improve diagnosis while reducing unnecessary biopsies and have enrolled 600 patients from multiple hospital districts for this randomized trial. Participants undergo biparametric MRI bpMRI scans interpreted by an experienced urologist using specific scoring systems. Men are randomly assigned to two groups in the control group, all men receive biopsies after MRI in the intervention group, biopsies are done only after a shared decision process considering individual risk. Biopsies involve systematic and targeted samples depending on MRI findings. Men without biopsies or with negative results enter a five-year follow-up with regular PSA tests. During the study, participants undergo MRI scans, prostate biopsies when indicated, and follow-up PSA testing every six months for five years. Researchers assess the proportion of men with clinically significant prostate cancer Gleason 43 or higher at baseline, biopsy complications, anxiety levels through questionnaires, and biopsy rates. Long-term follow-up continues for 15 years using health records and registries to monitor outcomes beyond the initial study period.

This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had common bile duct stones successfully removed using endoscopy. The study focuses on patients 75 years and older, including those with additional health issues, to determine if avoiding surgery is as safe as performing cholecystectomy. The main measurement is a combined outcome of death, serious complications, or recurring biliary problems within one year after randomization. Participants are randomly assigned to one of two groups one will have laparoscopic cholecystectomy within two weeks following stone removal, and the other will be managed without surgery but can have cholecystectomy later if needed. The study includes an interim safety check after the first 100 participants, with a plan to stop early if significant differences arise. Both groups are monitored over time to assess health outcomes and complications. During the study, participants will be followed for at least one year to track outcomes such as survival, complications, biliary events, quality of life, pain, and healthcare costs. Assessments occur at various intervals, including 30, 180, and 365 days after randomization. Researchers will evaluate these factors carefully to understand the benefits and risks of each approach, ensuring participant safety throughout the trial.

Researchers are evaluating whether adding azithromycin to the usual antibiotic cefuroxime before hysterectomy can reduce infections that occur after the surgery. The study focuses on women undergoing hysterectomy for non-cancerous reasons and aims to see if this combination lowers the risk of deep infections within 30 days post-operation. It also looks at other infections like superficial wound infections, urinary tract infections, fever episodes, and possible side effects of these antibiotics. Additionally, the study investigates the role of bacterial vaginosis and the vaginal microbiome in these infections. Participants are randomly assigned to receive either azithromycin 500 mg orally when they arrive at the hospital on the day of surgery plus a single dose of cefuroxime 1.5g for those with body mass index under 30 or 3g for BMI 30 or above before the surgical incision, or a placebo plus the same cefuroxime dose. The azithromycin or placebo is given as two tablets by mouth, and the cefuroxime is given once intravenously in the operating room. This design is triple-blinded to compare the effects fairly. During the study, researchers monitor participants for signs of deep infections or other infections and fever from day 1 to day 30 after hysterectomy. Assessments include clinical evaluations and possibly electrocardiograms to check heart rhythm safety. The main outcome measured is the number of deep infections occurring within 30 days post-surgery. The study runs until December 2030, with participants followed closely during this 30-day period to track infections and any side effects from the antibiotics.

This research evaluates the use of drug-coated balloons DCB compared to drug-eluting stents DES in patients with stable coronary artery disease CAD or acute coronary syndrome ACS who are at high risk of bleeding. The study aims to test whether using DCB with a shorter dual antiplatelet therapy DAPT regimen is not worse than using DES with a longer DAPT duration. If the DCB strategy is found not inferior, its superiority over DES will be further assessed. Participants will receive either a DCB or a DES during percutaneous coronary intervention PCI. The DCB group uses the SeQuent Please device combined with a tailored antithrombotic regimen based on patient stability and oral anticoagulation use. The DES group involves implantation of various CE-marked drug-eluting stents alongside individualized antithrombotic treatment. Treatment regimens vary between stable patients and those with ACS, with differences in DAPT duration and lifelong therapies. Throughout the study, participants are monitored for major adverse cardiac events MACE and bleeding episodes using the BARC classification over 12 months as the primary outcome. Additional outcomes include mortality, revascularization events, myocardial infarction, stroke, and bleeding tracked up to 36 months. The study uses a randomized, triple-blind design to compare these treatments with ongoing safety and efficacy assessments.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Carpal tunnel syndrome is a common nerve compression disorder in the upper limbs, causing symptoms like pain, numbness, and tingling in the fingers, often worse at night. This trial aims to compare the effects of wearing a wrist splint at night only, full-time day and night splinting, and no treatment on symptom relief. The study also looks to identify which patients benefit most from splinting and whether a positive response reduces the need for surgery. The study is a randomized cross-over trial conducted in Finland with 110 participants. Participants will experience all three treatment periods in a random order wearing a neutral-positioned wrist splint at night for six weeks, wearing the splint both day and night for six weeks, and a six-week no-treatment control period. Each treatment period is separated by a three-week washout phase, making the total treatment sequence last 24 weeks after randomization. In addition, participants will perform self-administered stretching exercises throughout the study and avoid any other medical interventions such as steroid injections or surgery during the trial. During the study, participants will complete self-report questionnaires electronically to assess symptom changes using the 6-item CTS Symptoms Scale and the Boston Carpal Tunnel Questionnaire at multiple time points, including during and after each treatment period and up to one year after randomization. Researchers will monitor overall improvement, quality of life, adverse effects, need for surgery, and any escape treatments over the one-year follow-up. The study provides detailed monitoring of symptoms and function to evaluate the benefits of different splinting schedules.

Researchers are evaluating the effectiveness of trapeziectomy surgery compared to sham surgery in patients with persistent painful osteoarthritis at the base of the thumb CMC1. This multi-center, randomized, placebo-controlled trial aims to understand how these treatments affect pain and hand function, with the main focus on patient-reported outcomes six months after treatment. The study also monitors longer-term effects up to five years. Participants are assigned to one of three groups the trapeziectomy group, which undergoes surgical removal of the trapezoideum bone the sham surgery group, which receives only a skin incision without actual bone removal and a non-randomized observational group receiving trapeziectomy without blinding. Both surgical procedures are performed under medical supervision, and the study compares outcomes between these groups. During the trial, participants will report their wrist and hand function and pain levels using the Patient Reported Wrist and Hand Evaluation PRWHE at multiple time points 3 months, 6 months, 1 year, 2 years, and 5 years. Other assessments include grip and pinch strength, global improvement, patient-accepted symptom states, and quality of life measured by the EUROQOL EQ-5D-5L. The study is designed to carefully monitor patient experiences and outcomes over an extended period to better understand the impact of trapeziectomy on thumb osteoarthritis.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.