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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.
Actively Recruiting
Researchers are conducting a joint effort across 32 medical centers in Europe, the USA, and South Africa to validate two new questionnaires designed to measure how patients perceive the severity and control of Chronic Rhinosinusitis (CRS), with or without nasal polyps. The goal is to assess these questionnaires in routine medical settings and compare their results with existing tools for evaluating CRS. The study will recruit a total of 1000 patients diagnosed with chronic rhinosinusitis according to the EPOS guidelines. Patients will come from regular ENT practices at participating hospitals, ensuring the study's procedures fit within usual care. There are no investigational treatments; the focus is on validating and evaluating the questionnaires. Participants will complete the new questionnaires over approximately six months. Researchers will collect data, conduct statistical analysis, and create study reports through the University of Leuven's statistical department. The main outcomes include validating the questionnaires and evaluating their results compared to other assessment tools during the study period.
Actively Recruiting
Researchers are investigating the effects of different doses of dexamethasone, a corticosteroid, in adults with acute hypoxemic respiratory failure (AHRF) caused by infections, including COVID-19. This condition ranges from mild respiratory illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The trial aims to clarify whether moderate doses of dexamethasone reduce mortality more than low doses in patients requiring mechanical ventilation in intensive care units. Participants will be randomly assigned to receive intravenous dexamethasone either at a low dose of 6 mg per day for 10 days or a higher dose regimen of 20 mg per day for 5 days followed by 10 mg per day for another 5 days. This is a randomized, controlled, open-label study conducted across multiple centers in Spain. The study focuses on patients who are mechanically ventilated with confirmed pulmonary or systemic infections causing AHRF or ARDS. During the study, researchers will monitor patients for 60-day mortality as the main outcome and assess the number of days they are free from mechanical ventilation within 28 days. The study follows the intention-to-treat principle, ensuring all randomized patients are analyzed according to their assigned treatment. The trial includes detailed clinical assessments, chest imaging, and oxygenation measurements as part of patient evaluation throughout the treatment period.
Actively Recruiting
The study focuses on patients with splenomegaly or those who have undergone splenectomy without a clear diagnosis, as well as patients with thrombocytopenia. Researchers aim to improve diagnosis sensitivity for Gaucher disease (GD) and Acid Sphingomyelinase Deficiency (ASMD) among these patients, especially in those with monoclonal gammopathies of undetermined significance (MGUS) or multiple myeloma (MM). Previous research suggests increased frequency of MGUS and MM in GD and ASMD patients, but many cases of splenomegaly remain unexplained despite standard evaluations. The study involves the use of usual clinical diagnostic procedures alongside collecting blood samples for a dry drop test (DBS) to measure enzymatic and genetic activity related to GD and ASMD. Analysis of specific markers LisoGl1 and LisoSM will also be conducted. The investigation seeks to identify the prevalence of these diseases in the patient population over a 36-month period. Participants will undergo clinical evaluation, blood testing, and enzymatic/genetic assessments to help identify GD and ASMD. Researchers will monitor the prevalence of these diseases and related conditions throughout the study. The study includes adult patients aged 18 to 99 years, and those who participate will provide consent for assessments and follow-up. Safety and diagnostic results will be observed during the entire study duration.
Actively Recruiting
Waldenstr f6m's macroglobulinemia (WM) is a disorder where certain immune cells in the bone marrow grow abnormally, leading to a detectable monoclonal immunoglobulin M (IgM). Its symptoms vary and may be caused by tumor spread or the IgM protein itself. Treatment options differ widely, and there is limited information on their effectiveness in initial or relapse cases. In Spain, the number of people diagnosed with MGUS-IgM and WM over the past decade is unknown. This observational, retrospective study aims to create a national registry of patients diagnosed with WM and MGUS-IgM in Spain over the past 30 years. Researchers will collect data from clinical records of patients diagnosed according to WHO criteria, including those unable to give consent if approved by ethics boards. The gathered data will be managed by the Spanish Myeloma and Lymphoma Intergroup and overseen by principal investigators in each center. Participants' clinical features, treatments, and outcomes will be analyzed to understand long-term safety, effectiveness, and prognosis of different therapies. The study will help inform future treatment strategies and clinical trials in Spain. The primary outcome is overall survival measured through study completion, averaging 4 years.