Sant Joan D Alacant

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Reflex syncope, the most common type of syncope, is caused by an imbalance in the autonomic nervous system leading to fainting due to low brain blood flow. It affects people of all ages and can significantly impact quality of life, especially in cases with frequent or injury-causing episodes. While pacemaker therapy has been helpful for some patients with cardioinhibitory reflex syncope, cardioneuroablation (CNA) has recently emerged as a new treatment option aimed at reducing the frequency of these episodes by targeting heart nerve clusters. The study compares CNA and permanent pacemaker therapy in patients over 40 years old with cardioinhibitory reflex syncope. CNA involves locating and ablating specific atrial ganglionated plexi using radiofrequency energy delivered through a catheter, with treatment endpoints including heart rate changes and response tests. The pacemaker group receives a dual-chamber device programmed with specialized algorithms. The trial evaluates which treatment better reduces syncope over 12 months. Participants will be monitored for syncope recurrence, quality of life, and heart function through ECG and tilt tests, with follow-up lasting at least one year. Researchers will assess the effectiveness and safety of CNA compared to pacemaker therapy by measuring syncope rates and related outcomes. The study aims to guide treatment decisions for patients with frequent, severe cardioinhibitory reflex syncope.

Researchers are evaluating a structured multidisciplinary approach called iABC to improve the management of elderly patients with atrial fibrillation (AF) who have multiple other health conditions. This study aims to provide clear evidence that this integrated approach can improve clinical outcomes and quality of life compared to usual care. The research is conducted in Bulgaria, Denmark, Italy, Romania, Serbia, and Spain and focuses on patients aged 65 years and older with AF and multimorbidity. The iABC approach follows the ABC pathway focused on three key areas: preventing stroke with anticoagulation (using optimized vitamin K antagonists or direct oral anticoagulants), better management of AF symptoms, and optimized care for related cardiovascular and non-cardiovascular conditions. The study uses a novel platform incorporating education, a healthy or functional diet and physical activity, guideline-based drug treatments, and regular reassessments. Clinical centers in each country are randomized to either implement the iABC approach or continue with usual care. Participants will be outpatients with confirmed AF and at least one additional long-term health condition such as hypertension, coronary artery disease, or diabetes. Researchers will monitor outcomes including the impact of iABC on all-cause unplanned hospitalizations over 12 months. Assessments include guideline-based diagnosis confirmation, regular follow-up, and monitoring of treatments and lifestyle changes. Safety and adherence will be evaluated throughout the study, which aims to provide holistic care improvements for this high-risk population.

Researchers are investigating how a mindfulness-based program, including one with virtual reality, may affect university students' balance in daily activities and reduce psychological distress like stress, anxiety, and depression. The study focuses on university students who face high rates of mental health challenges that impact academic performance and well-being. This trial aims to explore mental health, psychological functioning, and occupational outcomes, along with how these effects last over three months. The trial is a single-blind, three-group randomized clinical study comparing a traditional mindfulness program, a mindfulness program combined with virtual reality, and a passive control group on a waiting list. Each intervention lasts six weeks, with participants attending sessions designed to promote mindfulness. The virtual reality component aims to enhance engagement given students' familiarity with technology. Participants will be evaluated before the program starts, daily during the six-week intervention, immediately after completion, and again at an 18-week follow-up. Assessments include questionnaires measuring occupational balance, anxiety, depression, stress, academic stress, and burnout. Data will be collected online using validated tools, and qualitative feedback will be gathered through focus groups. The study tracks adherence and monitors mental health throughout to understand both immediate and lasting effects.

Researchers are evaluating the safety and effectiveness of GLSI-100 immunotherapy in people with HER2/neu positive breast cancer who are at high risk of the cancer coming back. This Phase 3 study focuses on individuals who have completed both neoadjuvant and postoperative adjuvant standard treatments, including trastuzumab-based therapy. The study includes participants who are HLA-A*02 positive, with an additional open-label arm for non-HLA-A*02 positive subjects, aiming to understand how this immunotherapy may help prevent invasive breast cancer recurrence. Participants receive treatment through a series of injections: six intradermal injections as the Primary Immunization Series over the first six months, followed by five booster injections given every six months. One group receives the investigational GLSI-100, which contains GP2 and GM-CSF, while a control group receives placebo injections containing normal saline. The open-label arm explores the treatment in non-HLA-A*02 positive subjects. Throughout the study, participants are monitored for invasive breast cancer-free survival over a median follow-up of four years, with interim analyses planned. Assessments include clinical evaluations to confirm no residual or persistent breast cancer, organ function tests, and pregnancy tests. Safety and efficacy data are collected to understand the treatment's impact, with participants followed closely during and after the treatment period to track outcomes and side effects.