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This research aims to observe the real-world use and effects of pegcetacoplan in adults diagnosed with Paroxysmal Nocturnal Hemoglobinuria PNH. As a new treatment with a unique mechanism of action, pegcetacoplans effectiveness and safety in routine medical practice are being studied to provide valuable information for patients, healthcare providers, and payers. The study will also gather data on blood transfusions and healthcare resource use before and after starting pegcetacoplan. Patients who have started pegcetacoplan treatment within the past 12 months or are prescribed the drug at enrollment will be included. Data collection includes retrospective information from up to 12 months before treatment start and prospective monitoring for approximately 36 months, with the total data period extending up to about 48 months. After stopping pegcetacoplan, patients remain in the study for 8 weeks to record any adverse events. Patients continue regular clinic visits, where data from each visit will be gathered. Participants will have data collected on various health measures such as hemoglobin levels, blood markers, transfusion needs, and patient and physician treatment satisfaction at regular intervals up to 36 months. Safety and adverse events will be monitored throughout. The main outcome measured is the change in hemoglobin level from treatment start to 6 months. This long-term observational study allows for comprehensive tracking of pegcetacoplans use and effects over time in usual care settings.

Researchers are evaluating the effectiveness of two chemotherapy combinations, 5-FU with nanoliposomal irinotecan NALIRI and 5-FU with nanoliposomal irinotecan plus oxaliplatin NALIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma PDAC who have progressed after treatment with Gemcitabine-Abraxane or Gemcitabine alone. This phase 2 randomized study aims to assess the progression-free survival rate and safety of these treatments in fit patients with good performance status. Participants receive treatment in 14-day cycles. In the NALIRI group, patients are given leucovorin, nanoliposomal irinotecan at 70 mgm, and 5-FU through intravenous infusion. The NALIRINOX group receives oxaliplatin, leucovorin, nanoliposomal irinotecan at 50 mgm, and 5-FU. The study monitors dosing adjustments based on individual tolerance, especially for patients with specific genetic markers. Treatments are administered mostly via intravenous infusions over several hours and continuous infusions over two days. During the study, participants undergo regular imaging scans, tumor marker tests, and safety assessments to evaluate treatment response and side effects. Researchers track progression-free survival at day 85 post-randomization and continue monitoring survival and disease control for up to five years. Safety is closely followed through laboratory tests, physical exams, and adverse event reporting until two weeks after treatment ends. The total participation time varies depending on individual treatment response and follow-up duration.

Researchers are evaluating a new treatment approach for colon cancer, focusing on a specific type called mismatch repair proficientmicrosatellite stable MMRpMSS colon cancer. This Phase 2 study compares a combination of dostarlimab with CAPEOX chemotherapy to CAPEOX chemotherapy alone. The study aims to find early signs of how well this combination works before surgery and to understand how blood and tumor markers might predict treatment response. Participants will be randomly assigned to receive either dostarlimab plus CAPEOX chemotherapy or CAPEOX chemotherapy alone. Both treatments are given before surgery, a process known as neoadjuvant therapy. The study includes two groups one receiving the combination treatment and the other receiving only chemotherapy. Treatment duration and follow-up are planned to assess response and safety. During the study, participants will undergo various assessments including tumor tissue collection via colonoscopy, evaluations of tumor response, and monitoring for adverse events. Researchers will measure major pathological response rates and track any side effects up to approximately 105 weeks. The study also looks at the percentage of participants who can undergo tumor removal surgery, and detailed pathological response rates. Safety and effectiveness are monitored throughout the treatment and follow-up periods.

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

Researchers are evaluating the efficacy, safety, and tolerability of adding ponsegromab to systemic chemotherapy compared to chemotherapy plus placebo for adults with metastatic pancreatic ductal adenocarcinoma mPDAC who have cachexia, a condition causing significant weight loss and fatigue. This Phase 2b3 randomized, double-blind, multinational study focuses on first-line treatment for this advanced cancer and associated cachexia. Participants will receive standard first-line chemotherapy regimens, either nab-paclitaxel plus gemcitabine or FOLFIRINOX, combined with either ponsegromab at one of two doses or a matching placebo. Study intervention is given subcutaneously every four weeks starting on the same day as the chemotherapy cycle and prior to chemotherapy administration. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants will either continue or switch to that dose while remaining blinded. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind phase. During the study, participants will have tumor assessments approximately every 6 to 8 weeks by independent radiologists. Researchers will measure changes in body weight, anorexia symptoms, physical activity, muscle and fat tissue quality, overall survival, and treatment safety through laboratory tests, adverse event monitoring, and patient questionnaires. The study duration extends through Phase 3 with ongoing monitoring until key survival events occur, with an additional optional sub-study assessing caregiver quality of life.

Central sleep apnea CSA involves periods during sleep when breathing temporarily stops or decreases due to a lack of effort to breathe. This condition can cause excessive daytime sleepiness and poor sleep quality and is linked to higher mortality in patients with heart failure. Researchers are studying the factors that influence treatment choices and how well patients follow these treatments for CSA in Belgium, as well as the effects of these treatments. Participants in this study will receive routine care as part of a registry, without additional interventions from the study. Eligible participants have a confirmed diagnosis of CSA based on specific breathing event measurements from sleep studies. This observational study will follow patients over five years to monitor their treatment decisions, compliance with treatments, and health outcomes. Throughout the study, participants treatment choices and compliance will be tracked along with assessments of their health-related quality of life and sleep quality using surveys like the Short Form 36 Health Survey and Pittsburgh Sleep Quality Index. Researchers will also monitor mortality over the five-year period. The study involves regular evaluations but no experimental treatments, focusing on real-world data collection to better understand CSA management.

Researchers are evaluating whether taking a low dose of colchicine daily, alongside standard treatment, can reduce cardiovascular events in patients with coronary artery disease CAD after treatment with percutaneous coronary intervention PCI. This phase III randomized, double-blind, placebo-controlled trial aims to confirm if colchicine helps prevent further incidents in CAD and to identify patients who might benefit most from this treatment. Participants will be randomly assigned to receive either colchicine 0.5 mg or a matching placebo once daily, in addition to their standard care. The trial plans to enroll up to 2770 participants and will continue until 566 primary endpoint events occur. Follow-up includes a clinic visit one month after randomization, then annual visits with additional telephone check-ins every six months. Throughout the study, participants will complete questionnaires and have their health outcomes monitored to assess events like death, heart attacks, strokes, and need for further coronary procedures over 44 months. Researchers will also evaluate patient-reported outcomes including angina frequency, breathlessness, depression, and quality of life. Medication adherence and safety will be closely tracked during scheduled visits and calls.

Researchers are investigating two types of radiofrequency RF treatments for people with chronic knee pain due to osteoarthritis OA or persistent pain after total knee replacement surgery. This condition affects many individuals, and current treatments do not always relieve the pain. The trial aims to compare the effectiveness and cost-effectiveness of conventional RF, cooled RF, and a sham procedure in reducing pain and improving quality of life over two years. The study includes three groups one receiving conventional RF treatment where heat is applied at 80C for 90 seconds to specific knee nerves another receiving cooled RF treatment that uses cooled probes to create larger lesions at around 60C to 80C for 150 seconds and a sham group where needles are placed but no actual RF energy is delivered. Before randomization, participants undergo a 1 to 3 month run-in period to ensure optimal conservative treatment. Patients are then followed for two years to assess outcomes. Participants will have multiple assessments including pain intensity, knee function, quality of life, psychological status, medication use, and physical tests at intervals up to 24 months after treatment. Researchers will monitor for adverse events and healthcare use throughout the study. The main outcome is measured by the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC at six months post-treatment, with ongoing evaluations to understand long-term effects and safety.

This research aims to evaluate how well differential target multiplexed DTM spinal cord stimulation works to treat chronic back and leg pain in patients with conditions like Failed Back Surgery Syndrome and Persistent Spinal Pain Syndrome Type 2. The study will also compare outcomes between patients using paddle or surgical leads and those using percutaneous leads to see if there are differences in effectiveness. Participants will receive spinal cord stimulation using the DTM approach as the main treatment. This device-based therapy will be monitored over time, with evaluations conducted at 1 month, 6 months, and 12 months after implantation. The study will collect detailed information on pain intensity, medication use, functional ability, quality of life, and other factors related to pain and daily living. During the study, participants will undergo assessments including pain ratings using the Visual Analogue Scale, measures of disability, psychological factors, and healthcare use. Data on device parameters, battery consumption, and any technical issues will also be tracked. Safety will be monitored by recording any adverse events throughout the study period. Overall, the study involves regular follow-up visits and evaluations over a year to understand the impact of DTM spinal cord stimulation on chronic pain.

Researchers are investigating head and neck squamous cell carcinomas HNSCC located in the oral cavity, oropharynx, larynx, or hypopharynx, specifically in patients with positive lymph nodes on only one side of the neck and no distant metastasis. The study focuses on evaluating two strategies the use of sentinel lymph node mapping to customize the areas of the neck to be irradiated and reducing the radiation dose. This research aims to decrease the volume and dose of radiation to the contralateral neck to minimize severe side effects while maintaining cancer control. Participants will undergo different radiotherapy approaches based on sentinel lymph node mapping results. If the scan shows drainage only on the tumor side and the tumor does not cross the midline, patients will receive radiation on the same side with a reduced dose, sparing the opposite side. If drainage to the opposite side is present, participants will be randomly assigned to either receive radiation to the entire lymph node level containing the sentinel node or only to the sentinel node itself, both at reduced doses. The treatment targets are adapted individually according to the lymph node drainage pattern. During the study, patients will be monitored for contralateral regional control over two years after radiotherapy. Quality of life questionnaires will be completed regularly during the first two years. Researchers will also assess normal tissue complication probability, local cancer control, overall survival, and radiotherapy-induced toxicity. The study includes imaging assessments and clinical evaluations to measure treatment effects and safety, with follow-up visits scheduled up to two years post-treatment.