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Found 9 Actively Recruiting clinical trials

A

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effect of the recombinant zoster vaccine on the risk of developing new dementia diagnoses among adults aged 76 years or older living in Finland. This phase IV pragmatic trial aims to assess whether receiving this vaccine influences the incidence of dementia, including Alzheimers disease, over a long follow-up period. Participants will be randomly assigned to receive either the vaccine or a placebo. Participants in the vaccine group receive two doses of the recombinant zoster vaccine the first dose on Day 1 and the second dose between 2 and 6 months later, following the approved dosing schedule. Those in the placebo group receive two doses of placebo injections on the same schedule. The study is randomized, placebo-controlled, and observer-blind to compare outcomes between these two groups. During the study, participants will be followed for up to 10 years after their first dose to monitor for new dementia diagnoses, death, or loss to follow-up. Researchers will use health register data to assess outcomes including new diagnoses of dementia and Alzheimers disease. Safety monitoring includes exclusion of severely immunocompromised individuals and those living in nursing facilities. The total participation duration allows long-term observation of vaccine effects on dementia risk.

Age: 76Years +All GendersPhase 4
8 locations
C

Actively Recruiting

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.

Age: 75Years +All GendersPhase Not Applicable
12 locations
U

Actively Recruiting

Healthy Volunteer

Researchers are investigating the complex causes and cellular makeup of hip osteoarthritis OA using advanced single-cell and spatial omics technologies. The study aims to identify different cell types in synovial tissues and blood samples from OA patients, compare these to non-arthritic tissues, explore inflammatory responses, uncover key molecular pathways, and differentiate OA subtypes. A sub-study also compares tissue and blood from patients with rheumatoid arthritis RA to better understand differences in disease mechanisms. The study involves three groups adults with hip OA undergoing elective total hip arthroplasty, adults with hip RA undergoing elective total hip arthroplasty, and non-arthritic adults undergoing trauma-based emergency total hip arthroplasty as controls. Researchers collect tissue and blood samples for detailed analysis using single-cell RNA sequencing and spatial omics to map the transcriptome and proteome while preserving tissue structure. Participants will undergo hip joint replacement surgery and provide samples for molecular analysis. The study timeline includes characterizing cell populations from early 2025 to late 2026, mapping cellular landscapes through 2026, identifying molecular pathways through 2027, and comparing RA and OA disease mechanisms through 2028. Researchers also study potential blood biomarkers and OA subtypes. The total duration spans several years with ongoing assessments and molecular mapping.

Age: 18Years - 74YearsAll Genders
4 locations
C

Actively Recruiting

Researchers are evaluating the use of intravenous IV contrast-enhanced computed tomography CT compared to native CT without contrast in adults with acute abdominal pain who have impaired kidney function. This study addresses concerns about the risk of post-contrast acute kidney injury PC-AKI in patients with reduced renal function, aiming to provide clearer evidence through a randomized controlled trial. The trial focuses on patients with an estimated glomerular filtration rate eGFR between 15 and 45 mlmin1.73 m2 who require emergency abdominal or body CT scans. Participants are randomly assigned to one of two groups one receiving abdominal or body CT with IV contrast, and the other receiving abdominal or body CT without IV contrast native CT. This open-label trial is conducted at multiple centers, comparing the effects and outcomes of these two imaging methods in patients with impaired kidney function. The study is designed to determine if the use of IV contrast affects mortality or the need for renal replacement therapy. During the study, researchers will monitor participants for outcomes including all-cause mortality and renal replacement therapy within 90 days after the CT scan. Additional evaluations include measuring acute kidney injury within 72 hours, any organ failure within 48 hours, hospital-free days within 90 days, and the time from CT to definitive treatment during the hospital stay. Participants will be followed closely after their CT scan to assess these outcomes and ensure safety throughout the study period.

Age: 18Years +All GendersPhase 4
3 locations
S

Actively Recruiting

This research aims to identify factors linked to no improvement in gastrointestinal quality of life after elective laparoscopic cholecystectomy for gallstones. The study focuses on patients who have symptomatic gallstones and undergo this surgery, with the goal of understanding outcomes related to abdominal symptoms and quality of life. Participants are observed without any additional intervention. The study monitors patients following their scheduled laparoscopic cholecystectomy, tracking their recovery and quality of life over time to gather data on gastrointestinal health. During the study, participants will complete questionnaires to assess their gastrointestinal quality of life using the GIQLI score at one year after surgery. Researchers will analyze these results to understand the impact of the surgery on abdominal symptoms and overall well-being. The study is observational and involves regular follow-up assessments over the course of the study period.

Age: 18Years +All Genders
2 locations
C

Actively Recruiting

Researchers are evaluating different imaging approaches for adults suspected of having appendicitis to see how they affect clinical outcomes. The study compares protocol-based selective imaging using clinical scoring to routine imaging with ultrasound andor CT scans. The main questions are whether selective imaging and selective observation combined with scoring affect outcomes like negative appendectomies or complicated appendicitis cases. Participants will be randomly assigned to one of three groups routine imaging with ultrasound and CT as needed selective imaging based on the Adult Appendicitis Score AAS or selective observation using the Appendicitis Severity Score ASS combined with AAS-based selective imaging. In the routine group, patients undergo ultrasound first, followed by CT if results are inconclusive, and urgent surgery if appendicitis is found. In the selective imaging group, patients with high AAS scores have surgery, those with moderate scores get imaging, and low scores are discharged. In the observation group, patients with low AAS are discharged, moderate scores are managed by ASS and observation protocols with re-evaluation, and high scores lead to surgery. During the study, participants will have imaging tests, scoring assessments, and possible observation periods. Researchers will monitor outcomes such as negative appendectomies and complicated appendicitis within 30 days of randomization, along with quality of life, costs, and adverse events up to one year. The studys total follow-up includes tracking appendicitis occurrences for up to two years. This allows evaluation of the safety and effectiveness of selective imaging protocols compared to routine imaging in suspected appendicitis cases.

Age: 18Years +All GendersPhase Not Applicable
3 locations
C

Actively Recruiting

Researchers are evaluating the effectiveness of two pain management methods in patients undergoing laparoscopic cholecystectomy LCC, which is surgery to remove the gallbladder. The study aims to compare the use of local ropivacaine infiltration at trocar sites alone versus combined with a laparoscopically guided transversus abdominis plane TAP block, called the STALL technique. This randomized controlled trial is designed to determine if STALL provides better pain relief than local infiltration alone, as previous smaller trials have not shown clear benefits of TAP block. Participants will be assigned to one of six groups based on their surgery type daycare, in-patient, or emergency surgery. Each group will either receive local ropivacaine infiltration alone or combined with the laparoscopic TAP block. The study treatments involve procedures performed during surgery to manage post-operative pain. Both methods use ropivacaine, a local anesthetic, applied either just at the wound sites or also via the TAP block guided by laparoscopy. During the study, researchers will monitor participants opioid use during recovery, which lasts approximately 1 to 4 hours, and record pain scores using the Numeric Rating Scale for up to two days after surgery. Opioid consumption will also be tracked for inpatient and emergency surgery patients while admitted, estimated at about two days. The study is double-blinded and randomized to ensure unbiased results. Participants will be followed throughout their hospital stay and recovery period to assess pain control and medication needs.

Age: 18Years +All GendersPhase Not Applicable
1 location
E

Actively Recruiting

Researchers are investigating long-term outcomes in survivors of out-of-hospital cardiac arrest, focusing on how different targets for sedation, temperature, and blood pressure management affect brain protection and recovery. This study is part of a larger international, multi-center randomized trial called STEPCARE. The study also explores the impact of caregiving on those caring for cardiac arrest survivors. Participants in the STEPCARE trial are randomly assigned to various combinations of sedation levels deep or minimal, temperature management using a feedback-controlled device or fever control without a device, and blood pressure targets high MAP above 85 mmHg or low MAP above 65 mmHg. These interventions are applied during the initial treatment period. The extended follow-up substudy enrolls survivors from selected sites who consent, following them and their nominated caregivers at 6 and 12 months after cardiac arrest. During the follow-up, researchers assess cognitive function of survivors using the Montreal Cognitive Assessment MoCA and measure caregiver burden with the Zarit Burden Interview ZBI at 6 months. The study includes questionnaires and evaluations to understand recovery and caregiving challenges. Participants are monitored over a total of 12 months, with data collected at both 6 and 12 months to evaluate long-term effects of the initial treatments and caregiving experiences.

Age: 18Years +All GendersPhase Not Applicable
34 locations
S

Actively Recruiting

Healthy Volunteer

This research aims to study how the condition of a tooth before treatment affects the outcome of partially removing decayed tissue in adult teeth. The main questions are whether preoperative symptoms and the depth of the decay influence the success of the treatment. The study will involve 100 adults with deep carious lesions, focusing on those with mild or reversible pulpitis, to better understand treatment results over time. Participants will undergo partial removal of decayed tissue, where decay is selectively removed from the tooth while preserving healthy tissue. The procedure involves removing decay around the edges of the cavity and selectively removing softened dentin near the pulp, followed by restoration with glass-ionomer cement. After 12 months, if the tooth shows no symptoms and passes sensitivity tests, a final restoration with composite resin is applied. During the study, participants will complete a questionnaire about symptoms 7 days after treatment, including pain assessment using a visual scale. The treated teeth will be monitored for 12 to 24 months with clinical and radiographic evaluations to assess treatment success. The research will track the tooths condition and response to treatment over time, supported by the University of Helsinki.

Age: 18Years - 50YearsAll Genders
1 location