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Found 4 Actively Recruiting clinical trials

S

Actively Recruiting

This research investigates why up to 25% of children who have surgery for tumors in the posterior fossa develop Cerebellar Mutism Syndrome CMS. CMS is a challenging condition marked by mutism, low muscle tone, coordination problems, and irritability. The study aims to understand the causes, clinical progress, and best ways to treat this syndrome in pediatric patients. The study is an observational, prospective, multicenter project including at least 2000 children from Nordic countries who have posterior fossa central nervous system tumors and undergo surgery or biopsy. Patients are treated according to local standards, while clinical data and imaging are collected centrally. Blood samples are gathered for genetic analysis, and neurological and speech assessments are done before and repeatedly after surgery. Data are recorded at five key times before surgery, within 72 hours after surgery, 1-4 weeks post-surgery, around 2 months post-surgery, and approximately 12 months post-surgery. If patients have repeated surgeries within 12 months, follow-up restarts accordingly. Participants will undergo neurological and speech function tests, including speech recordings, with extra assessments for children under 2 years. Blood samples are analyzed for genetic markers linked to CMS risk. Imaging and speech recordings are reviewed by specialists. Data quality is ensured by a third party. The main outcome measured is the development and progression of CMS one year after surgery. The study also tracks speech output reduction and treatments used during follow-up. Participation may last up to 12 months or longer if multiple surgeries occur.

Age: 0 - 18YearsAll Genders
32 locations
F

Actively Recruiting

Researchers are evaluating whether HbA1c screening can be performed effectively in dental care settings to detect elevated blood glucose levels in adults with advanced periodontitis and support referral to primary care. Advanced periodontitis is a chronic inflammatory disease linked to prediabetes, type 2 diabetes, and cardiovascular disease. Because of the two-way relationship between periodontitis and diabetes, patients with advanced periodontitis may be at higher risk of undiagnosed elevated blood glucose. Many such patients regularly visit dental clinics but may not otherwise be reached by medical prevention programs. In this observational study, adult patients aged 18 years or older with advanced periodontitis will undergo capillary HbA1c testing at public dental clinics using a validated point-of-care instrument during routine visits. Participants receive their test results immediately. Those with HbA1c levels of 42 mmolmol or higher will be given standardized information and referred to their primary care center for further diagnostic assessment and preventive follow-up, following usual clinical practice. Participants complete or update a health declaration before the HbA1c test. The study will measure participation rate, success of HbA1c testing, time needed for procedures, prevalence of elevated HbA1c, referral rates to primary care, follow-up completion within six months, dropout rates, and costs. Data for follow-up will be gathered from medical records and regional health registers. This research aims to find a practical model for collaboration between dental care and primary care to improve early detection of prediabetes and diabetes and strengthen prevention efforts for patients with advanced periodontitis.

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

Actively Recruiting

Researchers are evaluating an optimized expansion strategy for transcatheter aortic valve implantation TAVI in patients without atrial fibrillation who have severe native aortic valve stenosis. The study compares this optimized method, which involves systematic pre- and post-dilatation of the implanted valve, against the standard of care TAVI approach. The goal is to assess whether the optimized technique better reduces hypoattenuating leaflet thickening, a condition measured by cardiac computed tomography CT imaging three months after TAVI. Participants will be randomly assigned to one of two groups the standard of care TAVI group, where pre- and post-dilatation are optional and decided by the operator, or the optimized expansion TAVI group, where systematic pre- and post-dilatation are performed with an optimally sized balloon. The balloon size is based on specific measurements of the native aortic annulus. Both groups undergo the TAVI procedure using either self-expanding or balloon-expandable valves, with post-dilatation encouraged only under certain conditions in the standard care group. During the study, patients will have baseline assessments including medical history, electrocardiogram, echocardiography, and cardiac CT scans. Follow-up visits are scheduled at hospital discharge, and at approximately 3 months, 1 year, and 5 years post-procedure. At these visits, transthoracic echocardiography and various imaging studies like cardiac CT or PET-CT scans will evaluate valve leaflet thickening, valve performance, and other health outcomes. The primary outcome focuses on leaflet thickening at three months, with multiple secondary outcomes assessed up to five years to monitor valve function and patient safety.

Age: 18Years +All GendersPhase Not Applicable
17 locations
P

Actively Recruiting

Researchers are investigating a new diagnostic PET imaging agent called 64Cu-DOTA-AE105 to assess the aggressiveness of low-risk, localized prostate cancer without the need for repeated biopsies. This phase 2 trial focuses on patients with untreated prostate cancer verified by biopsy, aiming to see if the imaging agent can accurately classify cancer severity based on ISUP grades. The study is sponsored by Curasight and seeks to provide a less invasive method for monitoring prostate cancer progression. The trial is divided into two parts. In Part 1, participants receive two injections of the test drug on two separate days Day 1 and Day 8, followed by PETCT scans to capture images of the prostate. Dose groups include 100 MBq, 150 MBq, and 200 MBq of 64Cu-DOTA-AE105. Part 2 involves a larger group receiving a single injection of 200 MBq of the test drug with subsequent PETCT scanning. Before and after injections, participants undergo health evaluations including ECG, blood, and urine tests. Participants will be involved in imaging sessions on specified days with health monitoring before and after each scan. Researchers will measure the maximum standard uptake value SUVmax of the imaging agent at various time points post-injection to assess tumor visibility and consistency. Additional blood and urine samples will be analyzed to monitor drug distribution and elimination. Safety and diagnostic performance are evaluated throughout, with the entire study lasting until January 2027.

Age: 18Years +MALEPhase 2
9 locations