Leiria

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This Phase 3 program includes two separate studies with different treatment goals. Study 1 includes both induction and maintenance treatment and aims to see if tulisokibart doses are better than placebo in achieving clinical remission and endoscopic response at 12 and 52 weeks. Study 2 focuses only on induction treatment with similar goals measured at 12 weeks. Participants receive different dosing regimens of tulisokibart administered either intravenously IV or subcutaneously SC. Study 1 has groups receiving high or low dose IV tulisokibart followed by high or low dose SC tulisokibart maintenance, as well as placebo groups matching these routes. Study 2 includes induction treatment with high or low dose IV tulisokibart or placebo. Some participants may continue in extension arms with SC dosing after completing their initial study phase if they meet specific requirements. During the study, participants will be assessed regularly for clinical remission using Crohns Disease Activity Index scores or stool frequency and abdominal pain scores, and for endoscopic response by examination. These assessments occur at weeks 12 and 52 for Study 1 and at week 12 for Study 2. Researchers will monitor safety by tracking adverse events and treatment discontinuations. The total participation duration varies, with Study 1 lasting up to 52 weeks and Study 2 up to 12 weeks.

Researchers are studying the use of felzartamab for adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by buildup of abnormal IgA antibodies that damage kidney filters. The study aims to understand how felzartamab affects proteinuria, or protein in the urine, as well as kidney function, safety, and how the body processes the drug. This research is a Phase 3 randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney function will receive treatment in separate cohorts. After treatment, there is an 80-week follow-up period. In total, participants will have 17 study visits over about two years. During the study, researchers will measure changes in urine protein levels, kidney filtration rates, and other clinical endpoints. They will also monitor felzartamab levels in the blood, immune responses, and any adverse events. Safety assessments include vital signs, lab tests, ECGs, and physical exams. The study tracks participants closely throughout treatment and follow-up to evaluate felzartamabs effects on IgAN.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating the effectiveness of a physical activity coaching intervention delivered through an eHealth platform to improve physical activity levels and health outcomes in patients with Chronic Obstructive Pulmonary Disease COPD undergoing pulmonary rehabilitation. This randomized controlled trial includes patients who are clinically stable with COPD and enrolled in a pulmonary rehabilitation program. The study aims to assess whether this coaching approach can enhance patients activity during and after the rehabilitation period. All participants will attend a 10-week pulmonary rehabilitation program consisting of 20 sessions, including exercise training, educational sessions, and counseling on topics like medication, smoking cessation, and nutrition. At the midpoint week 5 of the program, the experimental group will start receiving a personalized physical activity coaching intervention via an eHealth platform, which includes a mobile app and web app for healthcare professionals. This coaching, continuing for 6 months after rehabilitation ends, involves weekly goal setting through phone calls, personalized notifications, and support to overcome barriers to physical activity. Participants will be assessed at multiple points the start, midpoint, and end of the pulmonary rehabilitation program, and again at 3 and 6 months after its completion. Researchers will monitor daily step counts using accelerometers and evaluate exercise capacity, breathlessness, fatigue, symptom impact, quality of life, and self-efficacy for physical activity. The study includes ongoing tracking of progress and health outcomes to better understand the long-term effects of the coaching intervention.

Researchers are evaluating whether promoting adherence to the Mediterranean Diet MedDiet can reduce symptoms of depression in adults diagnosed with Major Depressive Disorder MDD who have elevated inflammation markers such as C-reactive protein CRP and Interleukin 6 IL-6. The study aims to assess if adding dietary counseling to usual antidepressant medication treatment can improve depressive symptoms, inflammatory markers, quality of life, and the economic cost-effectiveness of care. This is a randomized, open controlled trial lasting 12 weeks with follow-up assessments at 6 and 12 months. Participants will be assigned to one of two groups the intervention group receives six personalized nutrition consultations over 10 weeks to encourage adherence to the MedDiet alongside their usual depression treatment, while the control group continues with their usual depression treatment alone. The dietary advice emphasizes increasing intake of olive oil, vegetables, fruits, legumes, fish, nuts, and poultry, and reducing intake of cream, butter, processed meats, sugary drinks, pastries, and fried foods. There are no calorie or weight change goals. During the study, participants will be evaluated at baseline, 12 weeks, 6 months, and 12 months for changes in depression symptoms using the Beck Depression Inventory-II BDI-II and inflammatory biomarkers. Researchers will also monitor quality of life and analyze cost-effectiveness. The trial plans to recruit about 700 participants, expecting 190 with elevated inflammation to complete the study. Safety and adherence will be tracked throughout the study period.

Researchers are evaluating whether adjusting exercise intensity to increase pleasure and arousal can improve physical activity behavior in patients who have experienced acute coronary syndrome ACS during a cardiac rehabilitation program. The study focuses on comparing physical activity levels and emotional responses between a group with exercise intensity manipulated for pleasure and a control group following a standard exercise program. This research is important because ACS patients face risks of recurrence and reduced quality of life, and promoting sustained physical activity is crucial for recovery and health. Participants will undergo sixteen personalized hospital exercise sessions, twice a week, during phase 2 of cardiac rehabilitation, alongside a complementary physical activity program integrated into daily life. The control group will follow conventional exercise guidelines based on the European Association of Preventive Cardiology principles, while the experimental group will have exercise intensity adjusted to optimize pleasurable feelings within safe intensity limits. Both groups receive pre-exercise evaluations and health briefings, and their programs last for eight weeks. During the study, participants will be assessed before and after the exercise program and again at three months follow-up. Physical activity will be measured using questionnaires and accelerometers. Researchers will also monitor emotional responses during exercise sessions, exercise habits, motivation, enjoyment, and physical health markers like body weight and abdominal circumference. These evaluations help understand how exercise intensity and pleasure influence activity levels and long-term adherence in cardiac rehabilitation.

Researchers are studying the effect of Ofatumumab treatment on people with Relapsing Multiple Sclerosis RMS in Portugal. This observational study compares patients who started Ofatumumab within 3 years of their RMS diagnosis to those who began treatment more than 3 years after diagnosis. The goal is to understand how effective Ofatumumab is in routine medical care settings. The study includes two groups one with early treatment initiation and one with later treatment initiation. Patients either started Ofatumumab up to 12 months before joining the study or start it at the time of inclusion. The study collects data over a period of up to 24 months across three main visits. Additional visits may occur if there is worsening of disability scores to confirm changes. Participants will complete questionnaires and assessments including the Multiple Sclerosis Impact Scale and Fatigue Symptoms Questionnaire at the start and during follow-up visits. Researchers will monitor disease activity using the No Evidence of Disease Activity NEDA-3 measure between 12 and 24 months. Treatment satisfaction and discontinuation rates will also be tracked. The study lasts up to two years per participant, with regular monitoring of disease status and treatment outcomes.

Researchers are evaluating how well seltorexant works and its safety when used alongside antidepressants in adults and elderly people with major depressive disorder and insomnia symptoms. This study focuses on participants who have not had adequate improvement from their current antidepressant treatment with selective serotonin reuptake inhibitors SSRIs or serotonin-norepinephrine reuptake inhibitors SNRIs. The trial aims to understand both the initial effects and the longer-term maintenance of seltorexant compared to placebo in this population. Participants in the study will receive either seltorexant or a matching placebo orally once daily for six weeks during the first double-blind treatment phase, while continuing their baseline SSRI or SNRI antidepressant. Those who complete Part 1 and meet criteria will enter Part 2, which includes an open-label phase where all receive seltorexant alongside their antidepressant. Participants achieving stable response may then continue with seltorexant or placebo during the double-blind maintenance phase. Throughout, all continue their original antidepressant treatment. During the study, participants will undergo assessments including depression rating scales such as the Montgomery-Asberg Depression Rating Scale MADRS and sleep disturbance questionnaires like the PROMIS-SD. The main outcomes include changes in depression scores after 43 days and time to relapse during maintenance, which may last up to nearly three years. Safety and tolerability will be closely monitored, and participants who do not continue to Part 2 will have a post-treatment follow-up after Part 1. Total participation may extend over several months or years depending on the study phase.

Researchers are evaluating the effectiveness, safety, and lasting effects of faricimab in Caucasian patients with symptomatic macular polypoidal choroidal vasculopathy PCV. PCV is a type of choroidal vasculopathy that causes hemorrhagic and exudative macular degeneration. This study aims to see how intravitreal injections of faricimab 6 mg affect best corrected visual acuity BCVA outcomes in these patients, addressing the current unmet needs due to disease heterogeneity and treatment challenges. The study involves administering faricimab injections directly into the eye following a treat and extend regimen tailored to each patient. It is an open-label, single-arm study lasting approximately 100 weeks, including a screening period of up to 28 days, a 12-week treatment initiation period, and a subsequent treat and extend phase extending to week 100. Participants receive faricimab at intervals up to 24 weeks based on their response and the study protocol. Participants will undergo regular eye examinations, safety assessments, and visual acuity testing using the ETDRS protocol. The study will monitor changes in BCVA from baseline through weeks 40, 44, 48, and up to 104 weeks, along with imaging to assess polypoidal lesion regression and retinal thickness. Adverse events will be tracked throughout the study. Overall participation spans more than two years, allowing detailed evaluation of faricimabs effects on vision and eye health in this population.