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Researchers are evaluating an artificial intelligence (AI) decision support system called Dermalyser to help primary care physicians distinguish skin cancer from benign skin lesions. This study is a multicenter, cluster-randomized controlled trial conducted at about 30 primary care centers across Sweden, Germany, Scotland, the Netherlands, and Australia. The aim is to assess the accuracy, reliability, and clinical usefulness of Dermalyser in real-world primary care settings where most patients with skin concerns are managed. The study also explores whether using this AI tool can improve early detection of skin cancer and reduce unnecessary removal or referral of benign lesions. During the study, participating primary care centers are randomly assigned to either use the Dermalyser device as a complementary diagnostic aid (intervention phase) or follow their usual clinical assessment without AI support (control phase). After enrolling half of the planned 3000 participants (1500 patients), the centers switch phases, allowing all to experience both approaches. Physicians decide on the clinical management of lesions, with Dermalyser providing additional information only during the intervention phase. Participants are followed for up to 5 years to monitor tumor diagnoses, skin cancer rates, and related health outcomes. Participants are patients attending primary care to have suspicious skin lesions checked. Researchers will assess the proportion of skin cancers diagnosed within six months of enrollment using standard clinical procedures. Throughout the study, data on diagnoses, morbidity, and mortality related to skin cancer will be collected. This long-term follow-up aims to determine differences between those assessed with and without the AI decision support. The study results could help improve skin cancer diagnostics and patient care in primary care settings worldwide.

Age: 18Years +All GendersPhase Not Applicable
8 locations
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Actively Recruiting

Heart failure with preserved ejection fraction (HFPEF) is a common and serious condition without effective treatment options. Researchers are evaluating whether adding spironolactone, a medication, to standard care can reduce the combined risk of cardiovascular death and hospitalizations for heart failure in patients with HFPEF. This study is a Phase 3 trial including patients from the Swedish Heart Failure Registry and the US, all having symptoms of heart failure, elevated heart-related blood markers, and an ejection fraction of 40% or higher. Participants are randomly assigned to one of two groups: one receiving spironolactone along with usual care, and the other receiving usual care alone without spironolactone. The study is designed as a registry-randomized clinical trial and will continue until 721 cardiovascular death or heart failure hospitalization events occur, with an enrollment period of 7 years and a total study duration of 9 years. Data collection in Sweden uses registry linkages, while data in the US comes from site reports and supplemented call center follow-up. During the study, researchers will monitor participants for hospitalizations due to heart failure or cardiovascular death as the primary outcome. Secondary outcomes include other hospitalizations, side effects, and how well patients follow their treatment plans. Outcomes are tracked through national registries and direct reporting, with the main data locked and analyzed five years after the study begins. Approximately 2000 patients aged 50 to 99 years will be included to achieve the event target needed for study conclusions.

Age: 50Years - 99YearsAll GendersPhase 3
78 locations
Finspang Clinical Trials | DecenTrialz