Espoo

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.

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 investigating the complex causes and cellular makeup of hip osteoarthritis (OA) using advanced single-cell and spatial omics techniques. The study aims to characterize cell populations in different joint tissues and blood samples from OA patients, compare these with non-arthritic tissues, and identify key molecular pathways involved in OA. A sub-study also compares tissue and blood components between OA and rheumatoid arthritis (RA) patients to explore differences in disease mechanisms. Participants include adults with OA or RA undergoing elective total hip replacement surgery, as well as non-arthritis controls having emergency hip surgery after trauma. The research involves analyzing tissue and blood samples using single-cell RNA sequencing and spatial omics to map gene and protein activity while preserving tissue structure. These methods help identify specific cell types and molecular signals linked to OA and RA. During the study, researchers will gather and analyze samples to understand cell populations, disease pathways, and potential biomarkers for OA. The primary outcomes focus on characterizing cells and molecular pathways from early 2025 through late 2028. Participant involvement includes surgery and sample collection, with no long-term treatment or additional interventions specified. The study timeline spans several years to cover detailed cellular and molecular analyses.

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.

Researchers are evaluating the safety and effects of intravenous contrast enhanced computed tomography (CT) versus native CT (without contrast) in adults with acute abdominal pain and impaired kidney function. This Phase 4, multicenter, open-label randomized controlled trial aims to address concerns about post-contrast acute kidney injury, which is a significant worry in patients with reduced renal function. The study focuses on patients with an estimated glomerular filtration rate (eGFR) between 15 and 45 ml/min/1.73 m2 who require emergency abdominal or body CT scans. Participants will be randomly assigned to receive either an abdominal or body CT scan with intravenous contrast or a native CT scan without contrast. The study compares these two diagnostic methods to see if intravenous contrast worsens kidney function or affects mortality. The trial is designed to follow patients for 90 days after their CT scan to assess outcomes. During the study, participants will be closely monitored for the combined outcome of death or the need for renal replacement therapy within 90 days following the CT scan. Researchers will collect data on kidney function and any adverse events, ensuring safety and effectiveness are carefully evaluated. The total duration of participation includes emergency imaging and a follow-up period to track these critical health outcomes.

This research aims to identify factors linked to no improvement in gastrointestinal quality of life after elective gallbladder removal surgery (cholecystectomy) for gallstones. It focuses on patients undergoing this surgery due to symptoms caused by gallstones. The study evaluates health-related quality of life and abdominal symptoms following the procedure. Participants in this observational study will undergo laparoscopic cholecystectomy for symptomatic gallstones. There is no intervention beyond the surgery itself, as the study mainly observes outcomes post-operation. During the study, researchers will assess participants' gastrointestinal quality of life using the Gastrointestinal Quality of Life Index (GIQLI) score one year after surgery. Participants will be asked to complete questionnaires about their health and symptoms, which will help measure the impact of the surgery on their quality of life.

Researchers are evaluating different imaging strategies for adults suspected of having appendicitis. The trial compares protocol-based selective imaging to routine imaging methods such as ultrasound and computed tomography (CT). The study aims to find out if using clinical scoring to guide imaging decisions affects clinical outcomes, including the rate of unnecessary appendectomies and complicated appendicitis. Participants will be randomly assigned to one of three groups: selective imaging based on the Adult Appendicitis Score; selective observation guided by the Appendicitis Severity Score combined with score-based selective imaging; or routine imaging using ultrasound and/or CT scans. Each approach is studied to see whether it impacts the number of negative appendectomies or complicated cases within 30 days after randomization. During the study, adults with suspected appendicitis will be monitored for clinical outcomes including negative appendectomy and complicated appendicitis within 30 days. Imaging will be done according to the group assignment, with follow-up to assess results. Researchers will compare the outcomes across the groups to evaluate the safety and effectiveness of the selective imaging protocols.

This research evaluates three different treatment targets for patients who are comatose after being successfully resuscitated from cardiac arrest. The trial involves 3500 participants and focuses on sedation levels, temperature management, and blood pressure goals to understand their effects on survival. The study aims to improve care strategies in the critical period following cardiac arrest by comparing different approaches in a randomized design. Participants are assigned to one of two groups for each treatment target: sedation (deep sedation for 36 hours versus minimal sedation), temperature control (using a feedback-controlled device at 37.5°C versus fever management without a device), and mean arterial pressure (MAP) targets (>85mmHg versus >65mmHg). Vasopressors will be adjusted to maintain the assigned MAP for 36 hours. The interventions are applied during intensive care after the cardiac arrest event. During the study, patients will be monitored closely with follow-ups at 30 days and 6 months after treatment. The primary outcome is survival at 6 months. Researchers will assess mortality and other health indicators during this period to determine the impact of the different treatment approaches. The total participation duration includes the initial treatment phase and these follow-up periods for outcome measurement.

Researchers are evaluating a new pain control method called STALL, which combines a laparoscopic ropivacaine TAP block with local trocar site ropivacaine infiltration, in patients undergoing laparoscopic cholecystectomy (LCC) for conditions like cholelithiasis, cholecystitis, or gallbladder cancer. This study is a prospective randomized superiority trial designed to compare the effectiveness of this combined approach with sole local anesthesia at the trocar sites. Previous trials have not demonstrated clear benefits of adding TAP block, so this study aims to provide stronger evidence with a larger sample size. Participants will be randomly assigned to receive either the STALL procedure, which includes single transversus abdominis laparoscopy-guided plane block combined with local trocar site ropivacaine infiltration, or just local trocar site ropivacaine infiltration alone. Both interventions are performed during laparoscopic surgery to control pain at the surgical sites. The trial is double-blinded to ensure unbiased results. During the participant's stay in recovery, lasting about 1 to 4 hours, researchers will measure cumulative opioid consumption to assess pain control effectiveness. Patients must be 18 or older and able to give informed consent. Safety monitoring and assessments will ensure proper evaluation of the treatments and participant well-being throughout the trial period.

This research aims to provide detailed information on the long-term outcomes related to neuroprotection and recovery improvements for survivors of out-of-hospital cardiac arrest. It evaluates different targets for sedation, temperature, and blood pressure management in these patients, as well as the impact on caregivers who support them. The study is part of a larger international, multi-center randomized trial called STEPCARE. Participants who survived out-of-hospital cardiac arrest and were part of the STEPCARE trial will be followed at selected sites. They will have experienced various interventions such as deep or minimal sedation, different blood pressure targets using vasopressors, and fever management either with or without a feedback-controlled temperature device. These treatments are applied during the first 36 hours after cardiac arrest. The study involves follow-up assessments at 6 and 12 months after the cardiac arrest event. Survivors will be evaluated for cognitive function using the Montreal Cognitive Assessment, while caregivers will be assessed for burden using the Zarit Burden Interview. The study plans to enroll about 600 survivors along with one nominated caregiver per survivor to understand both patient outcomes and caregiver impact over time.