Aveiro

This research aims to evaluate the effectiveness and safety of lebrikizumab in people with chronic rhinosinusitis and nasal polyps who are also treated with intranasal corticosteroids. The study is a Phase 3 clinical trial lasting about 18 months and includes participants aged 12 years and older. It is designed to understand how lebrikizumab works alongside standard nasal spray treatment for this condition. Participants will receive lebrikizumab through subcutaneous injections every 2, 4, or 8 weeks, depending on the assigned group. All participants continue using their regular intranasal corticosteroid sprays during the study. Adolescents aged 12 to under 18 years will receive open-label lebrikizumab injections every 2 or 4 weeks. There is also a placebo group receiving injections without the active drug but with the same nasal spray background treatment. During the study, participants will be monitored regularly for changes in nasal congestion and nasal polyp size over 24 weeks, using participant reports and endoscopic examinations. Other assessments include sinus imaging, lung function tests, smell loss severity, postnasal drip symptoms, and quality of life questionnaires. Safety and adherence will be closely observed throughout the 18-month study period to ensure participant well-being.

Researchers are studying the effects of mavorixafor in people aged 12 and older who have congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders. These disorders cause low levels of neutrophils, a type of white blood cell, leading to recurrent or serious infections. The study aims to show if mavorixafor can increase neutrophil levels and reduce infections, while also evaluating the drugs safety and how well participants tolerate it. Participants will continue their current treatments, which may include granulocyte-colony stimulating factor G-CSF, immunoglobulin replacement therapy, prophylactic antibiotics, or no active treatment. They will be randomly assigned to receive either mavorixafor or a placebo once daily by mouth for 52 weeks. The study is double-blind, meaning neither participants nor researchers will know which treatment is given until the study ends. Throughout the study, participants will be monitored for infections and neutrophil counts, with assessments including infection rates reviewed by a blinded committee. Other measures include infection severity, duration, antibiotic use, presence of oral ulcers, and fatigue levels from patient questionnaires. The research team will track safety and tolerability during the 52-week treatment period, with follow-up assessments to observe outcomes and any side effects.

Researchers are evaluating the effects of TAK-330 compared with a standard treatment known as four-factor prothrombin complex concentrate 4F-PCC for reversing anticoagulation caused by Factor Xa inhibitors in adults needing urgent surgery or invasive procedures. This Phase 3 trial aims to determine which treatment better controls bleeding during and after surgery in patients who require rapid reversal of blood thinning effects. Participants will be randomly assigned to receive either TAK-330 or the standard 4F-PCC treatment before surgery. TAK-330 is given as a single intravenous infusion of 25 international units per kilogram on the day of surgery, with an optional additional dose during surgery if needed, not exceeding a total dose of 50 IUkg or 5,000 IU. The standard 4F-PCC is administered according to local protocols, with a possible additional dose during surgery under similar dosing limits. During the study, patients will be hospitalized and monitored closely. Researchers will assess bleeding control during surgery, blood product use, and adverse events up to 30 days after surgery. Follow-up contact will be conducted by phone or telehealth 30 days post-surgery. The main outcome measured is the percentage of participants achieving effective bleeding control at the end of surgery.

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 evaluating the effects of the medicine BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. This study includes people with or without type 2 diabetes and those who may or may not be taking certain blood pressure medicines such as ACE inhibitors or ARBs. The goal is to understand if adding BI 690517 to empagliflozin helps reduce the risk of kidney failure, heart disease, or hospitalization due to heart failure. The study has two parts. In the first part, all participants receive empagliflozin or a placebo similar to BI 690517 for at least six weeks while continuing any indicated ACEi or ARB treatments. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the remainder of the study. The study lasts about three to four years until enough events related to kidney or heart health occur. During the study, participants visit the study site about four times in the first six months and then every six months afterward. At these visits, doctors check health status, collect blood and urine samples, measure blood pressure and weight, assess kidney function, and monitor any side effects. Researchers track the time until worsening kidney disease, heart failure hospitalizations, or cardiovascular death to compare outcomes between treatment groups.

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.

This research aims to evaluate the safety and effectiveness of the Hydrustent4 biodegradable hydrogel ureteral stent in adults with urinary lithiasis who have undergone surgery to remove ureteral or renal stones. The study will compare Hydrustent4 to a standard ureteral stent device to determine if it is at least as safe and effective in maintaining urine flow through the ureter after surgery. The trial includes both a pilot phase to explore initial safety and efficacy and a pivotal phase to confirm clinical performance. Participants will receive either the Hydrustent4 stent or a comparator ureteral stent after stone removal surgery. The Hydrustent4 device is designed to degrade naturally in the body, potentially avoiding the need for a second surgery to remove the stent, while the comparator is a conventional polyurethane double loop stent. The study will monitor the durability of the device for at least 24 hours and assess whether the device reduces urinary symptoms and prevents additional surgical procedures. During the 3-month follow-up period, participants will attend regular visits for assessments including questionnaires, imaging exams, and blood and urine tests to monitor recovery and device performance. Researchers will closely track safety through adverse events and device issues, evaluate urine drainage after stent placement, and assess symptoms related to the stents. The study will measure both technical success and tolerability of the devices throughout the treatment and follow-up phases.

Resistant hypertension is a severe form of high blood pressure that remains above the target level despite using multiple medications, affecting about 10-20 of people with hypertension worldwide. Researchers are studying the safety and effectiveness of two types of isometric exerciseshandgrip and wall squatto see if they can help lower blood pressure in people with resistant hypertension. The study aims to determine which exercise is safer and more effective by comparing their effects to a control session. Participants will first complete an acclimatization session to learn the procedures and measure their exercise intensity. Then, each person will take part in three sessions in random order a control session with no exercise, an isometric handgrip session involving four 2-minute repetitions at 30 of maximal grip strength, and an isometric wall squat session with four 2-minute repetitions at 95 of peak heart rate. Rest periods are included between repetitions, and participants will be encouraged to breathe normally and avoid holding their breath. During the study, blood pressure will be monitored before, during, and after each session, including ambulatory blood pressure measured every 20 minutes up to 12 hours post-session. Researchers will also track any adverse events occurring during or up to 48 hours after exercise. The study is randomized with single masking and will last from July to September 2024. Participants will be adults aged 40 to 75 with resistant hypertension and stable medication use.

Living with chronic obstructive pulmonary disease COPD or interstitial lung disease ILD presents significant daily challenges for both patients and their informal caregivers, especially in advanced stages. These needs are often not fully met by current treatments. This study investigates whether adding palliative care education to pulmonary rehabilitation PR can improve knowledge about palliative care for people with COPD or ILD and their informal caregivers. Participants will be randomly assigned to one of two groups. The experimental group will receive a 12-week PR program that includes twice-weekly supervised exercise sessions and weekly education and psychosocial support sessions, with added components such as palliative care education sessions, peer-to-peer discussions, get-apart sessions, and online meetings. The control group will receive the same PR program without the palliative care education and extra sessions. Individual cases may be referred to specialized palliative care or other professionals based on specific needs. Throughout the study, participants will undergo assessments at the start, after 12 weeks end of PR, and again 6 months later. These will include questionnaires and tests covering health status, symptoms, quality of life, knowledge about palliative care and the disease, functional capacity, and caregiver burden. Qualitative data will also be gathered from the experimental group through focus groups to understand their perspectives. The primary outcome is knowledge about palliative care, with many secondary measures evaluated as well.

Researchers are studying people with interstitial lung diseases ILD to understand how their ability to perform daily activities, called functional status, changes over time. The study aims to explore what causes declines in functional status, evaluate tools that measure this ability, gather patients perspectives through interviews, track progression over two years, and develop a combined index to predict mortality. ILD causes lung inflammation and scarring, leading to breathing difficulties and muscle weakness that affect daily functioning and quality of life. This observational study includes several tasks first, validating functional status measurement tools with assessments at baseline and one week later second, conducting interviews to capture patient experiences third, tracking functional status and health outcomes every six months for two years aligned with routine appointments and finally, using collected data to create a multidimensional index predicting mortality. Assessments involve physical tests, questionnaires, interviews, and clinical data collection. Participants will be involved in about 90-minute sessions for each assessment at designated hospitals. Researchers will collect data on muscle strength, physical activity, symptoms, quality of life, hospitalizations, and mortality. The primary outcome is measured by the Short Physical Performance Battery at multiple time points. Safety and health status are monitored throughout, with data analyzed to understand functional decline and its impact in ILD over time.