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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

This observational study examines how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional Prevenzione Serena program at ASL CN2. It focuses on women aged 45 to 75 years who underwent routine screening between September 2023 and May 2024. The study evaluates the association between breast density categories BI-RADS A-D and the frequency of recalls for additional diagnostic tests, aiming to understand how dense breast tissue impacts detection and false-positive rates. The research includes an internal validation of Insight BD, an automated software used to measure breast density. This validation involves technical testing with a mammography phantom and comparisons of the softwares BI-RADS classifications with assessments from two radiologists. No treatments or interventions are given, as data are collected retrospectively from clinical records. The study also explores how factors like menopausal status, hormone therapy, and family history relate to breast density and screening outcomes. Participants data will be analyzed for recall rates for second-level exams such as ultrasound or MRI, false-positive findings, and breast density distribution. Researchers will monitor the softwares accuracy and agreement with radiologists readings. The primary outcome is the recall rate by breast density category during the screening period. The study aims to inform future personalized screening guidelines and improve breast cancer detection strategies for women with dense breasts.

Age: 45Years - 75YearsFEMALE
1 location
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Actively Recruiting

Researchers are investigating how emotional distress ED affects treatment outcomes in patients with metastatic breast cancer mBC who are receiving first-line therapies. This study focuses on the impact of baseline emotional distress on the effectiveness of various treatments according to breast cancer subtypes. Emotional distress is common among breast cancer patients and has been linked to poorer treatment adherence and quality of life, but its role in metastatic breast cancer treatment success is not well understood. Participants will be grouped based on their breast cancer subtype and receive standard first-line treatments accordingly triple-negative PD-L1 positive patients receive chemotherapy with immune checkpoint inhibitors, triple-negative PD-L1 negative patients receive chemotherapy alone, HR-positiveHER2-negative patients receive a CDK46 inhibitor plus endocrine therapy, and HER2-positive patients receive chemotherapy combined with trastuzumab and pertuzumab. Emotional distress and quality of life will be assessed through questionnaires at baseline and during treatment. During the study, patients will complete specific questionnaires to measure emotional distress, quality of life, and fear of cancer progression. Researchers will monitor progression-free survival and objective response rates over two years, comparing outcomes based on emotional distress levels at the start and early in treatment. Quality of life and psychological factors will also be evaluated over three months. All participants must provide informed consent and meet eligibility criteria before joining.

Age: 18Years +All Genders
37 locations
C

Actively Recruiting

This research aims to develop a system for continuously evaluating healthcare quality in semi-intensive care units. By collecting patient data and hospital structure information, the study will identify indicators of unsuccessful care tailored to different patient types. These indicators will help assess the overall quality of care in each semi-intensive care unit over time. The study will last for five years, from 2021 to 2025, during which data from patients admitted to semi-intensive care units will be gathered. Annually, a detailed report will be produced to analyze and compare the results from each unit, helping to track improvements or identify areas needing attention. Participants include all patients hospitalized in participating semi-intensive care units, with an expected total of at least 39,000 patients over the study period. Researchers will monitor outcomes for various patient risk groups to assess healthcare quality. The study involves ongoing data collection and yearly evaluations to support continuous quality improvement in these care units.

All Genders
18 locations
U

Actively Recruiting

Mild traumatic brain injury TBI is a common reason for visits to emergency departments EDs. Researchers are studying how brain computed tomography CT scans are used in Italian EDs to assess patients with mild TBI. The study aims to understand the variability in CT use, validate existing clinical decision tools, and develop a new model to predict medium-term outcomes for patients with mild head trauma. The study observes adult patients who come to the ED with mild head trauma, defined by a Glasgow Coma Scale score between 13 and 15. Patients with longer-lasting loss of consciousness or amnesia are excluded. Researchers will analyze when and how CT scans are used and compare this with guidelines such as the Canadian CT Head Rule and others. They will also validate current scoring systems and work on creating an improved decision-making tool to help doctors decide when CT scans are necessary. Participants will be monitored from September 2025 through August 2027. During this time, researchers will assess CT scan use, validate common scoring methods, and develop a new score. The study involves reviewing patient data and clinical outcomes to better understand the best practices in managing mild TBI in the ED. This research aims to improve patient care by reducing unnecessary CT scans while identifying those at risk of serious complications.

Age: 18Years +All Genders
24 locations
S

Actively Recruiting

Researchers are studying patients with low-risk endometrial uterine cancer to understand if isolated tumor cells ITC found in the first lymph nodes near the tumor can provide important information about the patients future, especially regarding disease recurrence. This observational study compares patients with ITC in sentinel lymph nodes to historical patients with negative sentinel lymph nodes to evaluate differences in recurrence likelihood. Participants do not receive any new treatments as this is a non-interventional study. Patients undergo tissue sample collection and have their medical records reviewed as part of the study procedures. The study focuses on patients who have undergone complete surgical staging including pelvic sentinel lymph node biopsy and ultrastaging, with no additional treatment after surgery. During the study, researchers will monitor recurrence-free survival for up to five years along with other outcomes such as non-vaginal recurrence-free survival and overall survival. Participants medical data and tissue samples are collected for analysis. The study is expected to last several years, with ongoing review of patient outcomes and safety measures throughout the observation period.

All Genders
20 locations