Asti

Researchers are evaluating trastuzumab deruxtecan T-DXd as a treatment for adult patients with advanced HER2-positive gastric or gastroesophageal junction GEJ adenocarcinoma who have previously received a trastuzumab-based regimen. This study aims to assess the real-world effectiveness of T-DXd, patient characteristics, treatment patterns, and safety in this population. It also includes data collection on patients receiving conventional therapies for exploratory comparison. This is a non-interventional observational study where patients receive T-DXd or conventional therapies as part of routine clinical care according to approved guidelines SmPC. No investigational drugs are given. The study tracks patients starting T-DXd as a second-line or later treatment and collects data on other therapies such as chemotherapy and immunotherapy used in clinical practice. Participants will be followed for up to approximately 2 years from baseline to monitor outcomes including time to next treatment, changes in treatment, physician-reported safety events, use of prophylactic treatments, and quality of life using validated questionnaires. Data on physician visits, treatment discontinuation, and safety events will also be collected to understand treatment tolerability and patient experience in a real-world setting.

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation PVI using high power short duration HPSD radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation AF. This prospective, multi-center study aims to understand the relationship between clinical and procedural factors and the success and safety of this ablation method, with a follow-up period of 12 months to monitor AF recurrence. Patients with paroxysmal or persistent AF will undergo catheter ablation using approved mapping systems and catheters. The procedure involves sedation or anesthesia, vascular access through femoral or subclavian veins, and placement of diagnostic and ablation catheters in the left atrium. Ablation is performed with a QDot Micro catheter delivering radiofrequency energy in specific modes to isolate pulmonary veins. Effectiveness of the isolation is confirmed during the procedure, and any reconnections are addressed. Post-procedure, an ECG and optional echocardiogram are done to check for complications. During the 12-month follow-up, patients will have regular assessments at 3 months including history, physical exams, ECG, and 24-hour Holter monitoring to detect arrhythmia recurrence. Additional follow-ups between 6 and 12 months help confirm freedom from arrhythmia if no symptoms are reported. Researchers will measure outcomes such as arrhythmia recurrence rates, procedural times, vein reconnection, anesthesia impact, pain perception, and fluoroscopy duration to evaluate the procedures overall safety and efficacy.

Researchers are evaluating the combination of JSB462 luxdegalutamide with abiraterone compared to an androgen receptor pathway inhibitor ARPI, which includes abiraterone or enzalutamide, in adult males with metastatic hormone-sensitive prostate cancer mHSPC. This Phase II study aims to assess the effectiveness and safety of two doses of JSB462 100 mg and 300 mg daily combined with abiraterone and to select the recommended dose for future Phase III trials. The study will analyze overall treatment response, safety, tolerability, and pharmacokinetics. Participants will undergo a screening period of 28 days before starting treatment. During treatment, they will receive daily oral doses of JSB462 at either 100 mg or 300 mg combined with abiraterone 1000 mg, or they will receive abiraterone 1000 mg or enzalutamide 160 mg alone. Treatment continues until disease progression, unacceptable side effects, death, or decision by the participant or investigator. After treatment ends, there is a 30-day safety follow-up visit, followed by a long-term follow-up period to collect ongoing safety, efficacy, and survival information until the study concludes. Throughout the study, participants will have regular assessments including prostate-specific antigen PSA levels, imaging scans, adverse event monitoring, dose adjustments, and pharmacokinetic sampling. Patient-reported outcomes and various survival and response rates will be evaluated up to approximately 83 months. Safety follow-up visits occur about 30 days after treatment stops, and long-term monitoring continues until the studys end, ensuring comprehensive data collection on treatment effects and participant well-being.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are studying patients experiencing arrhythmic storm, a serious heart condition characterized by frequent and sustained ventricular arrhythmias that do not respond to standard antiarrhythmic drugs. This international multicenter observational study aims to evaluate the safety and effectiveness of Percutaneous Stellate Ganglion Block PSGB in reducing arrhythmic relapses in such emergency cases. The study is coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, and addresses a gap in large-scale data on this procedure. Participants who meet the criteria will receive PSGB using either the anatomical or echo-guided approach. Depending on patient needs, the procedure may involve a single anesthetic injection or continuous anesthetic infusion via a catheter connected to a pump. The study compares the number of arrhythmic events and defibrillations before and after PSGB treatment and notes any complications occurring within 12 hours post-procedure. During participation, patients will be monitored closely for arrhythmic relapses using defibrillation counts and anti-tachycardia pacing data. Complications such as hematomas, vascular injuries, and nerve damage will be recorded. Data are collected using a secure electronic system, with effectiveness measured by arrhythmic event reduction in the 12 hours following PSGB compared to the 12 hours prior. The study plans to enroll patients over several years with ongoing safety and outcome evaluations.

Researchers are collecting epidemiological data on adults newly diagnosed with myelodysplastic syndrome MDS through a regional network of registries in Italy. The study aims to use a standardized electronic case report form to gather and anonymously share data across regions and with other international MDS registries. This observational study helps better understand the incidence, prevalence, and progression of MDS over time. Participants are adults diagnosed with MDS who consent to share their medical data. The study does not involve any treatment or intervention but focuses on data collection and monitoring through regional registries. The network facilitates aggregation and analysis of anonymous epidemiological information to support research and improve knowledge on MDS. During the study, researchers will track key outcomes over six years, including new MDS diagnoses, response rates, prevalence, overall survival, progression-free survival, and progression to acute myeloid leukemia AML. Participants information will be collected and stored securely without altering standard medical care. The study is expected to continue until May 2032, with ongoing data collection and long-term follow-up.

Researchers are observing adult male patients with metastatic castration resistant prostate cancer mCRPC who are treated with lutetium 177Lu vipivotide tetraxetan. This non-interventional, prospective, multicenter study aims to describe routine clinical practice and gather real-world data on this treatment. The study will follow patients for a maximum of 18 months after their treatment ends. The study includes patients who have been prescribed lutetium 177Lu vipivotide tetraxetan by their treating physician team. There are no additional experimental treatments or interventions, as this is an observational study. The observation period covers from the start of treatment up to 18 months post-treatment, including monitoring during the treatment duration. Participants will be monitored through regular clinical assessments and data collection on outcomes such as progression-free survival, overall survival, prostate-specific antigen response, pain medication use, and quality of life measures. Researchers will also track hospitalizations related to the treatment, dosimetry, number of visits, and workdays lost. The total involvement for each participant can last up to 18 months after treatment completion.

Researchers are conducting the PREgnancy and FERtility PREFER study to improve care and understanding of fertility preservation and pregnancy issues in young women with breast cancer. This comprehensive program includes two parts one focusing on fertility preservation choices and outcomes, and the other on managing breast cancer diagnosed during pregnancy and the health of children born after cancer treatment exposure. The study collects data over a long time to better understand these important topics. The PREFER study gathers information on fertility preservation strategies available in Italy, including patients preferences, the techniques used, and their success and safety. It also tracks breast cancer cases diagnosed during pregnancy or soon after, monitoring pregnancy management, child health after exposure to cancer treatments in the womb, and outcomes for survivors who become pregnant later. The program is carried out across multiple Italian centers under a research group. Participants provide data through medical records and follow-up over many years. Researchers measure how many patients choose fertility preservation, the types of treatments given during pregnancy, pregnancy complications, survival rates, ovarian function recovery, number of eggs preserved, and pregnancies achieved after treatment. They also evaluate hormone changes during chemotherapy and the health of children born to affected mothers. The study continues for up to 15 years to gather long-term safety and outcome information.

This research investigates the use of a structured telenursing program for women with breast cancer receiving cyclin-dependent kinase CDK inhibitor therapy. These treatments can cause side effects that reduce treatment adherence and quality of life. The study aims to determine if scheduled remote nursing follow-ups can help detect and manage these side effects earlier to improve clinical outcomes and reduce complications such as hospital visits and treatment interruptions. Participants are randomly assigned to receive either standard nursing care or standard care plus a structured telenursing intervention. The telenursing program involves scheduled telephone or video consultations at set times during treatment cycles, where trained nurses assess symptoms, provide education, support medication adherence, and identify early signs of treatment toxicities. When significant issues arise, patients are referred promptly to physicians for further management. During the study, participants undergo regular assessments of side effects, treatment adherence, hospital visits, and quality of life using questionnaires and clinical data collected at baseline and throughout up to six months of treatment. The study measures the incidence and severity of adverse events, emergency visits, hospitalizations, and patient-reported outcomes to evaluate the effectiveness of the telenursing intervention compared to standard care.