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Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are studying metastatic breast cancer in a program aiming to recruit 1300 patients from hospitals across Europe. Eligible participants are adults aged 18 or older, male or female, with a recent diagnosis of metastatic or locally advanced breast cancer or disease relapse who have not received more than one type of treatment for metastases. The goal is to better understand genetic changes in metastatic breast cancer and discover how tumors respond or resist therapy to eventually identify the most suitable treatment for each patient. The study is sponsored by the Jules Bordet Institute and focuses on molecular analysis of cancer samples. Participants will undergo a biopsy of a metastatic lesion either at program entry or up to six months before inclusion, and a sample of the primary tumor must be available. Blood, serum, and plasma samples will also be collected. These samples will be analyzed centrally, and any unused samples will be stored in a bio-repository for future research. The study offers the possibility for patients with certain genetic changes to join related clinical trials if available and approved in their country. Throughout the study, participants provide blood samples at screening and regular intervals during follow-up. Researchers will evaluate genetic alterations, identify exceptional responders and rapid progressors, and assess patient prognosis over up to 10 years. The study will also monitor the feasibility of molecular screening and correlate molecular findings with standard measures of treatment response. The total study duration extends to March 2031, with primary outcome review planned one year after recruitment ends.

Researchers are evaluating the use of distal radial access DRA compared to conventional transradial access TRA for coronary catheterization procedures. This trial aims to assess whether advanced hemostasis methods and ultrasound-guided puncture can improve the success rate and reduce the time needed for hemostasis with DRA. This is important as DRA may offer safer vascular access with fewer complications, but its success rate and hemostasis duration require further study. The study compares several approaches use of a potassium ferrate hemostatic patch to enhance hemostasis in both distal radial and conventional transradial access, and the use of ultrasound guidance versus conventional guidance for distal radial access puncture. Participants will be randomly assigned to one of these methods. The study measures the duration of hemostasis from the end of the procedure and the success of vascular access placement. Participants will undergo coronary angiography or percutaneous coronary intervention with assigned access and hemostasis methods. Researchers will monitor hemostasis duration and access success, recording the time from anesthesia needle contact to sheath placement. Participants must have palpable radial pulses and meet other inclusion criteria. The total study period spans from enrollment through the procedure and hemostasis monitoring until completion, with no masking of treatment allocation.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

This research investigates the real-world use of the HeartInsight algorithm, designed to predict acute heart failure events in patients with implanted Biotronik ICD or CRT-D devices that have atrial sensing and Home Monitoring capabilities. Heart failure is a serious condition with high rates of hospitalizations and healthcare costs. The HeartInsight algorithm, validated in previous studies, monitors trends in seven physiological parameters to provide early warnings about worsening heart failure, aiming to improve patient management by alerting healthcare providers well in advance. Patients enrolled in this prospective, multicenter observational registry will be followed for 12 months across approximately 14 centers in Italy. The study does not require additional diagnostic tests beyond standard care. When HeartInsight issues an alert, a standardized workflow guides clinical responses such as device adjustments, therapy changes, or extra visits. Patients may also choose to use the HeartInsight Patient App to assist in monitoring. The study collects data on how often alerts occur, the clinical actions taken, patient interviews, and hospitalizations. Participants will have their device data remotely monitored and attend regular clinical visits as part of routine care. Researchers will track the proportion of alerts that lead to clinical actions and measure secondary outcomes like alert frequency, duration of alert periods, patient interviews, hospitalizations, and app usage. Data are collected securely via electronic forms and monitored for quality. The study aims to provide insights into integrating predictive monitoring tools into everyday practice to potentially enhance heart failure care over a 12-month period.

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 studying patients with first progression or recurrent glioblastoma, a type of brain tumor that often returns despite initial treatment. This study aims to compare the effectiveness of lomustine alone versus lomustine combined with reirradiation to see if the combination can improve overall survival without reducing quality of life. The study is a randomized Phase III trial sponsored by the European Organisation for Research and Treatment of Cancer and will include patients who have had prior standard chemoradiotherapy and meet specific health criteria. Participants will be randomly assigned to one of two groups one receiving lomustine alone and the other receiving lomustine plus reirradiation. Lomustine is given orally, while reirradiation is administered at least six months after the previous radiotherapy. The trial includes planned interim analyses to evaluate the effectiveness and safety of the treatments. During the study, participants will be closely monitored through overall survival assessments up to 40 months after enrollment. Researchers will also track progression-free survival, health-related quality of life, toxicity profiles, neurocognitive functioning, and treatment responses. Safety and quality of life will be assessed throughout the treatment and follow-up periods, ensuring comprehensive evaluation of the combined therapy compared to lomustine alone.

Researchers are evaluating the medicine pelacarsen TQJ230 compared to a placebo in adults with atherosclerotic cardiovascular disease ASCVD who have high levels of lipoproteina and are already receiving inclisiran treatment to lower their LDL cholesterol. This study is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial with a parallel group design to assess the efficacy, safety, and tolerability of pelacarsen. Participants will be randomly assigned to receive either pelacarsen injections once a month for 12 months or placebo injections once a month for 6 months, followed by pelacarsen injections for the remaining 6 months during an open-label phase. All participants also receive background inclisiran treatment consisting of two initial loading doses three months apart, followed by doses every six months as per approved guidelines. During the study, participants will have regular visits and assessments including laboratory tests to measure lipoproteina levels and monitor safety. Researchers will track changes in lipoproteina concentration at baseline and six months, along with adverse events and treatment tolerability over up to 16 months. The trial aims to understand how pelacarsen affects lipoproteina levels and overall safety when combined with inclisiran in this patient group.

Researchers are studying acute intoxications in children to better understand how often these poisonings occur and what social and care factors contribute to them. This research focuses on children from 1 month to 16 years old who experience acute intoxication, aiming to improve future national diagnostic and treatment approaches. The study is a prospective, multicenter observational cohort conducted by AMIETOX at Poison Control Centres and paediatric emergency rooms. The study observes children who come to emergency rooms or contact Poison Control Centres due to acute intoxication, defined as exposure to harmful substances either by toxic nature or improper use. It does not involve specific treatments or interventions but records data over approximately one year to assess incidence and prevalence. This observational approach allows researchers to collect real-world information about poisoning cases in paediatric settings. Participants will be monitored through their visits or calls to study centers, with data collected on the nature and circumstances of the intoxications. Researchers will measure how often these poisonings occur and how widespread they are among children in the study. The study involves no active treatment or placebo, focusing instead on gathering information to inform better care strategies. Participation lasts about one year, during which safety and outcomes are tracked through standard care processes.