Sondrio

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

Researchers are conducting a phase III randomized clinical trial to study early stage Follicular Lymphoma, a type of lymphoma that has not been treated before. The trial compares the effects of local Radiotherapy alone versus Radiotherapy combined with the drug Obinutuzumab. The goal is to better understand how these treatments work for patients with early stage Follicular Lymphoma and to evaluate progression-free survival and other outcomes. Participants will be randomly assigned to one of two groups one group will receive involved-site Radiotherapy at a standard dose of 24Gy alone the other group will receive the same Radiotherapy followed by Obinutuzumab infusionsfour weekly doses plus four additional doses every three weeks, totaling eight doses. This open-label study is conducted across multiple centers. During the study, participants will be monitored for treatment response and side effects over a period of up to 45 months, including 9 months of treatment and 36 months of follow-up. Assessments include imaging scans, laboratory tests, and molecular analyses to evaluate response rates, disease progression, and molecular markers. Safety and adverse events will be tracked throughout, with long-term follow-up to understand treatment effects and disease status.

This research investigates patients who have experienced aneurysmal subarachnoid hemorrhage aSAH, a type of stroke caused by bleeding from a ruptured brain aneurysm. The study focuses on a complication called delayed ischemic neurological deficit DIND, which can lead to delayed cerebral ischemia and poor neurological outcomes despite early treatment. Researchers aim to understand how often DIND occurs, how it is diagnosed, and the treatments used across different centers, as well as the impact on patients recovery both short- and long-term. Participants include those diagnosed with aSAH, confirmed by imaging tests, who are admitted to intensive care. The study collects data on neurological symptoms and imaging to identify DIND and monitors instrumental methods like continuous EEG and ultrasound for diagnosis, especially in patients unable to be examined clinically. Researchers also observe various treatment approaches such as blood pressure management, local drug infusions, and mechanical interventions like angioplasty to compare their use and outcomes. During participation, patients undergo neurological examinations and imaging tests including CT and MRI to assess brain function and injury. Instrumental monitoring of intracranial pressure and cerebral blood flow is recorded to support diagnosis and management. The study follows patients for 12 months to measure the incidence of DIND and evaluate neurological and functional outcomes over time. Data on treatment intensity and monitoring usefulness are also collected to improve understanding of managing this condition.

Researchers are evaluating outcomes and their predictors in various neurosurgical conditions to improve the quality and consistency of research and clinical care. The study focuses on standardizing the assessment of clinical, cognitive, and psychological status before and after neurosurgical interventions across multiple centers. This effort aims to create a common language in routine practice and support better therapeutic decisions through shared data and identified predictive factors. The study collects detailed clinical and demographic information from patients undergoing neurosurgery for a wide range of conditions, including tumors, vascular diseases, trauma, spinal disorders, functional pathologies, peripheral nerve issues, and malformations. Data such as comorbidities, anesthesia details, complications, and psychological assessments are gathered before surgery and at follow-ups, with timing varying by condition. An artificial intelligence analysis will be used to identify important predictors and outcomes. Participants will provide data over a period of up to five years, including sociodemographic details, clinical status, cognitive and psychological assessments, and complication records. The study monitors these factors preoperatively and postoperatively to describe outcomes and explore associations with preoperative indicators. The long-term collection of data supports understanding neurosurgical results and guiding patient care more precisely.

Researchers are evaluating the effectiveness of maintenance treatments using niraparib alone versus niraparib combined with bevacizumab in women newly diagnosed with advanced stage IIIA, IIIB, or IIIC high-grade epithelial ovarian cancer who have no visible disease remaining after initial surgery and chemotherapy. This phase II, randomized, open-label multicenter trial aims to compare these approaches following frontline surgery and adjuvant platinum-based chemotherapy with or without bevacizumab. Patients are stratified by BRCA status, cancer stage, and prior hyperthermic intraperitoneal chemotherapy. The study treatments include two groups one receiving carboplatin and paclitaxel chemotherapy over five cycles followed by daily oral niraparib for two years, and the other receiving the same chemotherapy plus bevacizumab for five cycles, then maintenance with both bevacizumab every three weeks for 15 months and daily niraparib for two years. Bevacizumab is administered intravenously starting with the second chemotherapy cycle. The trial investigates the impact of these regimens on progression-free survival and other long-term outcomes. Participants will undergo regular assessments including imaging scans between surgery and chemotherapy to confirm no disease, laboratory tests to monitor organ and bone marrow function, and physical exams during treatment. Researchers will track progression-free survival up to 24 months and other outcomes such as time to subsequent treatments, long-term overall survival, and treatment safety over up to five years. The study involves a total participation period that includes treatment and follow-up evaluations.

This research aims to collect and analyze clinical activity and management data from Orthogeriatrics and Orthopedics Units treating geriatric patients with hip fractures. By continuously gathering data over a long period, the study seeks to compare how different centers manage care and to guide improvements in clinical practice within orthogeriatrics. The study is a multicenter, prospective observational cohort study enrolling an estimated 7,000 patients aged 65 and older over five years. Data collection can be done either continuously with high intensity on all new cases or yearly with low intensity involving a smaller set of variables over one month. Centers voluntarily choose their preferred data collection method. Participants will be followed for 120 days after enrollment, with an additional four months allowed for the last patients to complete follow-up. Researchers will collect clinical data to assess management approaches, track fracture patterns and patient profiles by age, and evaluate improvements in clinical practice and interdisciplinary collaboration. The study will run for approximately five years and monitor outcomes related to orthogeriatric care models and sensitivity to elderly patient needs.