Sant Joan D Alacant

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Reflex syncope, the most common type of fainting, can cause injuries and reduce quality of life. It results from an imbalance in the autonomic nervous system leading to low blood flow to the brain. Current non-drug and drug treatments often have limited success. This study aims to compare the effectiveness of cardioneuroablation CNA, a newer catheter-based heart procedure, with permanent pacemaker therapy in reducing episodes of cardioinhibitory reflex syncope in patients over 40 years old. Participants will be randomly assigned to one of two groups one receiving cardioneuroablation, which targets specific heart nerve clusters using radiofrequency energy to modulate autonomic function, and the other receiving a dual-chamber pacemaker programmed with specialized algorithms. The CNA procedure includes pre- and post-testing to confirm treatment effects, while the pacemaker group receives device implantation. Both groups will be followed for at least 12 months to assess treatment outcomes. Throughout the study, participants will undergo evaluations including heart rhythm monitoring during syncope episodes, tilt table and atropine tests to assess nerve function, and quality of life assessments. Researchers will track the number of syncope and presyncope events, long-term changes in heart nerve activity, complications, heart rhythm changes, and arrhythmia burden. Safety and effectiveness will be monitored over a year to guide optimal treatment choice for this condition.

Researchers are evaluating a structured multidisciplinary approach called iABC to improve the management of elderly patients with atrial fibrillation AF who have multiple long-term health conditions. This study aims to compare the iABC approach with usual clinical care to see if it leads to better clinical outcomes and quality of life. The iABC strategy focuses on three key areas preventing stroke with appropriate anticoagulation, improving symptom control, and optimizing treatment of related heart and other health conditions. The trial is conducted across several European countries including Bulgaria, Denmark, Italy, Romania, Serbia, and Spain. The study is designed as a cluster randomized trial where participating centers are assigned either to implement the iABC platform or continue their usual care practices. The iABC platform combines an educational program, a healthy diet and physical activity plan, guideline-based medication management, and regular patient reassessments. Doctors using iABC can monitor patient data and provide personalized advice on treatments and lifestyle throughout the study. Centers in the control group will manage patients according to their local standard care guidelines. Participants will be followed for at least 12 months to assess the impact of iABC on outcomes such as unplanned hospitalizations, stroke and cardiovascular events, physical activity levels, patient engagement, and medication adherence. The study includes regular data collection to monitor these factors and assess adherence to the iABC care pathway. This approach aims to provide clear evidence about whether a holistic, integrated care model can improve health and quality of life in older adults with AF and multiple health issues.

Researchers are investigating the effects of two types of mindfulness-based programs on occupational balance and psychological distress, including stress, anxiety, and depression, in university students. This study focuses on mental health challenges faced by students, particularly post-pandemic, where depression, anxiety, and sleep disorders have become common. The research aims to also explore how these interventions influence other mental health and psychological factors and whether benefits persist three months after the programs. The study is a single-blind, randomized clinical trial with three groups a traditional mindfulness-based health care program MBHC, an MBHC program combined with virtual reality MBHC-VR, and a passive control group on a waiting list. Each program lasts six weeks with weekly group sessions and home practices. The MBHC-VR group completes formal mindfulness practices using virtual reality technology. Participants in the control group do not receive the intervention during the study but are offered the mindfulness program after a three-month follow-up. Participants will be undergraduate, master, or doctoral students who complete assessments before, during, immediately after, and three months following the intervention. Researchers will use questionnaires, ecological momentary assessment, and focus groups to measure changes in occupational balance, anxiety, depression, stress, academic stress, burnout, emotional regulation, psychological flexibility, mindfulness, self-compassion, life satisfaction, diet adherence, sleep, physical activity, and mental representations. The study includes monitoring attendance and internet access for completing assessments and practices.

This research investigates GLSI-100 immunotherapy in people with HER2neu positive breast cancer who are at high risk for their cancer returning. It focuses on participants who have completed both neoadjuvant and postoperative adjuvant standard treatments. The study is Phase 3, randomized, double-blinded, and placebo-controlled, involving subjects who are HLA-A*02 positive as well as an open-label group of non-HLA-A*02 positive subjects. The goal is to evaluate the treatments impact on invasive breast cancer-free survival over a median follow-up of 4 years. Participants receive 6 primary immunization injections of GLSI-100 or placebo intradermally once a month for the first 6 months, followed by 5 booster injections spaced 6 months apart, totaling 11 injections over 3 years. There are three groups one receiving placebo 0.9% normal saline, one receiving GLSI-100 immunotherapy in HLA-A*02 positive subjects, and an open-label arm for non-HLA-A*02 positive subjects receiving GLSI-100 under the same schedule. During the study, participants undergo regular monitoring and assessments including invasive disease-free survival, distant disease-free survival, overall survival, and quality of life questionnaires at baseline and up to 36 months. Researchers track safety and treatment effects over a median 4-year follow-up. The study continues until December 2031, aiming to provide comprehensive data on long-term outcomes and quality of life for participants receiving these treatments.