Crema

Researchers are studying patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC) who are at high risk of cancer recurrence. The study focuses on patients treated with ribociclib or abemaciclib combined with endocrine therapy (ET) in the adjuvant setting. It aims to understand clinical and pathological features, treatment outcomes, and recurrence patterns, especially among those who relapse during or within 12 months after receiving CDK4/6 inhibitors with ET. The study observes patients who have started or are starting adjuvant treatment with CDK4/6 inhibitors (either abemaciclib or ribociclib) plus endocrine therapy since January 1, 2021. There are no experimental treatments assigned, as this is an observational study conducted in multiple centers. It collects real-world data on therapeutic choices and patient responses to these treatments in a routine clinical setting. Participants will have their clinical and pathological data reviewed, including disease characteristics and treatment histories. Researchers will monitor disease-free survival over three years to evaluate invasive-disease free survival (IDFS). The study also examines recurrence patterns and outcomes for patients relapsing during or shortly after adjuvant therapy. Data consent and performance status assessments are part of participant involvement to ensure compliance and safety during the study period.

Researchers are evaluating treatment options for patients with advanced or metastatic pancreatic adenocarcinoma who have not experienced disease progression after 3 months of induction chemotherapy with mFOLFIRINOX. This phase III, randomized, open-label trial compares switch maintenance therapy using gemcitabine plus nab-paclitaxel against continued treatment with modified FOLFIRINOX. The study aims to determine which approach better supports overall survival in this patient population. The initial induction treatment consists of mFOLFIRINOX given every two weeks for up to 14 weeks (approximately 6 cycles). Patients showing complete or partial response, stable disease, or no progression after at least 4 cycles are randomized 1:1 to either continue modified FOLFIRINOX or switch to gemcitabine plus nab-paclitaxel. The switch maintenance therapy is administered on days 1, 8, and 15 of 28-day cycles. Stratification during randomization considers performance status and disease extent. Participants will undergo radiological tumor assessments before and after induction chemotherapy. Throughout the study, researchers will monitor overall survival up to 48 months from randomization. Safety and treatment effects are assessed regularly, and patients must meet specific health and laboratory criteria to participate. The study involves comprehensive monitoring to evaluate treatment impact and patient status during and after therapy.

Researchers are evaluating the use of Percutaneous Stellate Ganglion Block (PSGB) in patients experiencing arrhythmic storm, a serious emergency condition involving multiple sustained ventricular arrhythmias in 24 hours that do not respond to standard antiarrhythmic drugs. This international multicenter observational study, coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, aims to assess the safety and effectiveness of PSGB, which has limited large-scale evidence despite growing interest in neuromodulation treatments. Patients who meet the criteria will receive PSGB using one of two common approaches: the anatomical method, which targets Chassaignac's tubercle as the needle insertion point, or the echo-guided method. Depending on patient needs, the doctor may perform either a single injection of anesthetic or a continuous infusion via a catheter connected to a pump. This short-term study observes patients for 24 hours around the procedure. Participants’ arrhythmic episodes and the number of defibrillations will be recorded before and after PSGB to measure reduction in arrhythmic relapses within 12 hours post-procedure compared to 12 hours prior. Researchers will also track complications such as hematomas, vascular or nerve damage, and anesthetic side effects. Data will be collected electronically, and the study will monitor safety and effectiveness outcomes over time, potentially enrolling around 33 patients at the main center with expansion to other sites.