Brugge

Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder marked by loud snoring and repeated blockages of the upper airway during sleep, often causing daytime sleepiness. Researchers are collecting data on patients with OSAS who undergo maxillomandibular advancement (MMA) surgery, a procedure that permanently changes the upper airway to improve breathing. This prospective, observational study aims to create a database to track 3D volumetric changes in the upper airway, apnea-hypopnea index (AHI), and quality of life (QOL) after surgery. The study collects detailed virtual cone-beam computed tomography (CBCT) planning parameters as part of routine practice before MMA surgery performed by Dr. Neyt. Data from consecutive OSAS patients with an AHI of 5 or higher who have MMA surgery starting from January 2015 are included. The database tracks changes in the upper airway and its subregions, using 3D imaging and polysomnography, alongside patient-reported QOL measures such as the Epworth Sleepiness Scale and OSAS questionnaires. Participants undergo regular visits where demographic information, virtual planning data, surgical details, sleep study results, and quality of life questionnaires are gathered. The main outcome measured is the postoperative apnea-hypopnea index via polysomnography between 6 and 12 months after surgery. This ongoing registry aims to improve understanding of factors influencing MMA surgery outcomes and to support future research and quality of care assessments in OSAS treatment.

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults aged 18 to 70 years with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study continues from earlier trials and aims to monitor how well the treatment works and how safe it is over an extended period. Participants receive daily oral doses of ALKS 2680 tablets in varying strengths ranging from 4 mg to 18 mg. The study is an open-label, long-term extension, meaning all participants know they are receiving ALKS 2680 as they continue treatment after completing a prior parent study. The dose is administered once daily, and the study focuses on ongoing monitoring rather than comparing to a placebo. During the study, participants are regularly assessed for any treatment-emergent adverse events up to 100 weeks. Safety evaluations include clinical assessments, laboratory tests, and monitoring for any new health issues. Researchers track the ability to tolerate the medication and the durability of its effect on symptoms. This long-term follow-up helps ensure comprehensive understanding of the treatment's impact over time.

Researchers are evaluating the safety and effects of fosmanogepix, a study medicine, for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida species. This Phase 3 clinical trial compares fosmanogepix to the standard treatment of caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard therapy by a margin of 15%. The study includes adult patients diagnosed with these infections. Participants will receive either fosmanogepix or caspofungin as an intravenous infusion daily at the study clinic. After the initial infusion phase, patients may switch to oral tablets of fosmanogepix or fluconazole capsules, which can be taken at the clinic or at home if discharged. Treatment duration varies by individual, lasting up to six weeks depending on infection clearance and symptom improvement. A follow-up visit will take place six weeks after stopping treatment. During the study, patients will undergo multiple visits to monitor their health and treatment response. Researchers will assess outcomes such as the proportion of patients alive at 30 days and the overall treatment success at the end of study treatment, up to day 42. Safety will be closely monitored throughout the study and during follow-up, ensuring comprehensive evaluation of the treatments over the entire participation period.

Researchers are studying the real-world effectiveness of pegcetacoplan in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This long-term, multicenter observational study aims to fill knowledge gaps about how pegcetacoplan works in routine medical practice. It also seeks to provide important information on red blood cell transfusions and healthcare resource use before and after starting pegcetacoplan treatment. Patients who have started pegcetacoplan treatment within the last 12 months or are prescribed it at enrollment will be followed for approximately 36 months. The study will collect both retrospective data from up to 12 months before treatment start and prospective data during treatment, with a total data collection period of up to about 48 months. After stopping pegcetacoplan, patients will remain in the study for 8 weeks to monitor for any adverse events. Participants will attend their usual medical visits, and data from these visits will be collected, including effectiveness measures, safety reports, patient- and clinician-reported outcomes, and healthcare use. The primary outcome includes changes in hemoglobin levels over 6 months from the start of pegcetacoplan treatment. The study plans to enroll about 200 patients across multiple countries, and data collection includes both retrospective and prospective periods, capturing comprehensive information on pegcetacoplan use in real-world settings.

Researchers are evaluating the safety and feasibility of a new paddle-shaped, high-density, multi-electrode mapping catheter designed to map the atrial and ventricular regions of the heart. This study focuses on patients with various arrhythmias, including scar-related atrial tachycardia, persistent and paroxysmal atrial fibrillation, ventricular tachycardia, ischemic and non-ischemic ventricular tachycardia, cardiomyopathy, idiopathic ventricular tachycardia, and premature ventricular contraction. The goal is to assess how well the investigational catheter performs during endocardial mapping procedures. Participants will undergo mapping procedures using the investigational high-density multi-electrode catheter. The catheter will be used during clinically indicated catheter mapping and ablation procedures targeting ventricular tachycardia, premature ventricular complex, atrial tachycardia, or atrial fibrillation. The study includes monitoring for completion of all pre-ablation mapping requirements and any additional clinically needed mapping. This device-based intervention is evaluated up to 7 days after the index procedure. During the study, participants will be closely monitored for any serious adverse events related to the investigational catheter within 7 days after the procedure. Researchers will assess the success of mapping procedures and collect safety data. Participants must be willing and able to comply with all testing and follow-up requirements. The study includes safety monitoring and evaluation of the catheter's ability to complete mapping tasks essential for treatment planning.

Researchers are evaluating the effectiveness and safety of pirtobrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study focuses on two parts: Part 1 tests three different doses of pirtobrutinib in participants who have had 1 to 3 prior treatments, including a covalent Bruton tyrosine kinase (BTK) inhibitor. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have a specific genetic deletion called 17p. This is a phase 2, open-label, randomized study. Pirtobrutinib is given orally to participants in both study parts. Participants in Part 1 receive one of three dose levels, while those in Part 2 receive pirtobrutinib monotherapy. Part 1 participation lasts about 3 years, and Part 2 participation can last up to 2 years. The study compares the effects of different doses and treatment histories to better understand pirtobrutinib’s impact on CLL/SLL. Throughout the study, researchers monitor participants' overall response to treatment from the start up to 3 years. They assess safety and side effects, and participants are required to be able to swallow oral medication and have a performance status that allows them to participate. The study includes regular evaluations to determine how well the treatment controls the disease and to track any adverse events over the course of the study periods.

Researchers are evaluating the effectiveness of two treatment combinations, 5-FU with nanoliposomal irinotecan (NALIRI) and 5-FU with nanoliposomal irinotecan plus oxaliplatin (NALIRINOX), for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) that has progressed after initial gemcitabine-based therapies. This phase 2 randomized study focuses on patients who are physically fit with good performance status (ECOG 0-1). The main goal is to measure how long patients live without disease progression after starting these treatments. Participants will be randomly assigned to one of two groups. The control group receives NALIRI with 5-FU and leucovorin, while the investigational group receives NALIRINOX, which adds oxaliplatin to the same combination. Dosing varies between groups: NALIRI is given at 70 mg/m² with 2400 mg/m² of 5-FU and 400 mg/m² of leucovorin, while NALIRINOX includes 50 mg/m² of nanoliposomal irinotecan, 2400 mg/m² of 5-FU, 400 mg/m² of leucovorin, and 60 mg/m² of oxaliplatin. The study assesses safety, side effects, tumor response via imaging and tumor markers, and overall survival alongside progression-free survival. During the study, participants will undergo regular assessments including imaging scans to evaluate tumor size and response, blood tests to monitor safety and tumor markers, and evaluations of side effects using standard criteria. Researchers will track progression-free survival at day 85 from randomization as the primary outcome. The study also monitors overall survival and treatment tolerability. Participants must be monitored for safety throughout, with follow-up visits to assess long-term outcomes and treatment effects.

Researchers are evaluating treatments for participants with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. This Phase 3 study compares if the combination of belantamab mafodotin, lenalidomide, and dexamethasone (BRd) can extend progression-free survival or increase the number of participants achieving minimal residual disease negative status compared with the combination of daratumumab, lenalidomide, and dexamethasone (DRd). Participants will receive either BRd or DRd treatment. Belantamab mafodotin, lenalidomide, and dexamethasone will be administered in the BRd group, while daratumumab, lenalidomide, and dexamethasone will be given in the DRd group. The study will monitor participants over approximately 7 years to assess long-term outcomes. During the study, participants will undergo assessments to measure progression-free survival and minimal residual disease status. Researchers will collect clinical data, laboratory tests, and safety information throughout the treatment and follow-up periods. The total duration of participation may last up to about 7 years to evaluate long-term effects and outcomes of the treatments.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.