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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the MammoWave, an innovative microwave mammogram device, to confirm its ability to detect breast lesions. This multicentric, single-arm, prospective study focuses on women with breast cancer or benign breast lesions, stratified by breast density. MammoWave uses very low power microwaves to create images without ionizing radiation, making it safe for use at any age and any condition, including pregnancy and specific illnesses. Participants will undergo the MammoWave exam, which takes about 10 minutes. The exam is performed with the patient lying face down in a comfortable prone position, with the breast placed in a special container cup within the device. The exam includes an acquisition phase where microwave data is collected followed by data processing through an integrated imaging algorithm, producing images and related parameters. The study includes two phases: a preliminary phase to optimize the imaging algorithm with volunteers having no lesions, and a second phase where patients with breast lesions will be examined and compared to standard clinical diagnosis. During the study, participants will have a short visit that includes a qualitative assessment of breast density. The MammoWave exam results will be compared with previous radiological studies and histological findings when available. Researchers will measure MammoWave's sensitivity in detecting breast lesions, tracking the number of true positive results. The study involves multiple sites in Italy, Germany, and Spain and plans to enroll up to 600 participants.

Age: 18Years +FEMALEPhase Not Applicable
3 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the MammoWave device, which uses low-power microwaves instead of X-rays for breast cancer screening, in a large population of 10,000 women undergoing regular breast cancer screening programs. The study aims to confirm that MammoWave can achieve sensitivity greater than 75% and specificity greater than 90% in detecting breast cancer. This investigation is part of the MammoScreen project and involves multiple centers in Europe. Women participating in the study will first undergo a brief visit to check eligibility and review medical history. They will then have the MammoWave exam on both breasts, which includes an 8-minute data acquisition phase while lying prone on the device's bed, followed by data processing using specialized microwave imaging algorithms. The device will generate microwave images and classification results indicating the presence or absence of suspicious breast lesions. Participants will continue with their conventional breast screening examinations, such as mammograms, which serve as the reference standard for comparison. The study will monitor MammoWave's sensitivity and specificity during the procedure. Women aged 45 to 74 with average breast cancer risk and no symptoms are eligible, and the study excludes those with breast prostheses, prior breast cancer, certain genetic risks, pregnancy, or breast sizes too large for the device. The overall participation involves coordinating MammoWave testing with routine screening appointments and consenting to study procedures.

Age: 45Years - 74YearsFEMALEPhase Not Applicable
10 locations
B

Actively Recruiting

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Age: 18Years +All Genders
187 locations
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Actively Recruiting

This research focuses on patients with Severe Acquired Brain Injuries and aims to identify medium-term factors that can predict their rehabilitation outcomes. The study also seeks to develop a continuous system to assess the quality of care provided by rehabilitation units treating these patients. Identifying these prognostic factors helps understand which patients are likely to experience key rehabilitation milestones. Data will be collected from rehabilitation units and will include information about the units themselves and detailed patient data at admission and again four months after the acute brain injury event. The study will use statistical models to analyze the likelihood of achieving important rehabilitation goals such as removal of tracheostomy tubes, trunk control, and feeding entirely by mouth, all evaluated four months after the injury. Participants will be assessed at the start of rehabilitation and then re-evaluated four months later. The study measures include monitoring tracheostomy tube status, trunk control ability, and feeding methods. This allows researchers to track patient progress and evaluate care quality over time. The total participation duration includes the initial admission and follow-up assessments up to four months post-injury.

Age: 18Years +All Genders
27 locations
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