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This multinational Phase 4 study evaluates the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling in people aged 40 to 85 years with Chronic Obstructive Pulmonary Disease COPD. The study focuses on changes in mucus plugging and how these relate to lung function, exacerbations, and quality of life. Participants receive either dupilumab or placebo via subcutaneous injection according to the study protocol. Treatment lasts up to 24 weeks, and the total study duration can be up to 40 weeks. There are two treatment groups in a randomized, double-blind, placebo-controlled, parallel design. During the study, participants attend nine visits for assessments including lung imaging to measure mucus volume and airway wall thickness, lung function tests using forced oscillation technique, and monitoring for adverse events. The main outcome is the change in global lung mucus score from baseline to Week 24. Safety is followed through Week 36, with ongoing evaluation of lung inflammation and resistance.

Researchers are investigating whether tailored axillary surgery TAS combined with axillary radiotherapy ART is better than the current standard treatment, axillary lymph node dissection ALND, for patients with clinically node-positive breast cancer undergoing upfront surgery. The study aims to see if TAS plus ART improves arm-related quality of life and reduces the occurrence of lymphedema two years after treatment. This question arises because ALND, although standard, can cause significant side effects, and TAS selectively targets affected lymph nodes with potentially less harm. Participants will be randomly assigned to one of two groups one receiving ALND, which involves removing lymphatic tissue within the axilla, and the other receiving TAS with ART, where surgery removes sentinel and suspicious lymph nodes followed by targeted axillary radiotherapy. All participants will also receive breast or chest wall irradiation after breast-conserving surgery. The study compares these approaches to assess their impact on arm health and quality of life. During the trial, participants will be followed for at least two years to assess changes in arm-related quality of life and monitor for lymphedema. Researchers will collect quality of life questionnaires and clinical evaluations over this period. The study is sponsored by University Hospital Basel and aims to complete primary outcome assessments by the end of 2029, with overall study completion planned for 2037.

Sensory neuronopathies SN are rare neuropathies characterized by damage to sensory neurons in the dorsal root ganglia, caused by various conditions such as paraneoplastic, autoimmune, toxic, and genetic factors. The functional outlook for patients is generally poor, with many experiencing significant disability. Because there are no reliable biomarkers for SN, clinical scales are used to assess disease severity and treatment response, but currently available scales are not specifically designed or validated for SN. This study is evaluating the use of multiple clinical assessment tools over time to identify the most appropriate scale for tracking disease progression in sensory neuronopathies. Patients will be followed longitudinally with three visits at baseline, 6 months, and 12 months. At each visit, a variety of clinical scales and tests such as mISS, SEARS, CADT, SARA, ONLS, I-RODS, 9-Hole Peg Test, Timed Up and Go test, mRS, Quantified Rydel tuning fork test, Visual Analog Scale, and electroneuromyography ENMG will be conducted. Participants will provide demographic and medical history information at baseline and undergo assessments at each scheduled visit. Researchers will measure changes in clinical scores and neurological function to evaluate these tools effectiveness in monitoring SN. The primary outcomes include the Clinical Global Impression of Change and Patient Global Impression of Change at 6 and 12 months. The study lasts 12 months with comprehensive follow-up and safety monitoring to better understand disease progression.

Researchers are investigating the best approach to treat low-risk patients with isolated subsegmental pulmonary embolism SSPE, a type of blood clot in small lung arteries. The study aims to determine whether monitoring patients without anticoagulation is as safe and effective as giving anticoagulant medication. This is important because many patients currently receive anticoagulants that carry a risk of bleeding, but it is unclear if all patients with isolated SSPE need this treatment. Patients in the trial are randomly assigned to one of two groups. One group receives the anticoagulant drug rivaroxaban, starting with 15 mg twice daily for 21 days, then 20 mg once daily for a total of 90 days. The other group receives a placebo matching the same schedule. The trial compares clinical surveillance without anticoagulation to anticoagulation treatment to assess safety and effectiveness. Participants will be followed for 90 days after randomization to monitor for recurrent venous thromboembolism, significant bleeding events, and overall survival. Researchers will track these outcomes through clinical assessments and safety monitoring. This study is designed to evaluate if careful monitoring alone is a safe alternative to anticoagulation in selected patients with isolated SSPE, potentially reducing bleeding risks from treatment.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Researchers are collecting real-world data from cancer patients who receive radiotherapy to better understand the role of radiation oncology within a multidisciplinary treatment approach. This open-ended, prospective, non-interventional study aims to support radiotherapy research by observing patients over time without providing therapeutic interventions. The study includes patients with various cancer types who are planned to receive radiotherapy. Participants include patients treated with radical radiotherapy for oligometastatic disease as well as those receiving high-dose re-irradiation. The study is organized into multiple cohorts, such as OligoCare and ReCare, based on the type of radiotherapy treatment. Since it is an observational study, no experimental treatments or placebos are given. During the study, researchers will collect data on patient outcomes including disease-free survival, loco-regional control, distant metastasis-free survival, overall survival, and any adverse events related to radiotherapy over a period of five years. The main measure is the number of patients treated with radiotherapy enrolled in the program. Participants will have their health and treatment effects monitored regularly throughout this timeframe to provide valuable information about radiotherapy outcomes in real-world clinical settings.

This research aims to evaluate the effectiveness of early minimally invasive image-guided hematoma evacuation combined with best medical treatment BMT compared to BMT alone in patients with spontaneous supratentorial intracerebral hemorrhage SSICH. SSICH is a serious form of stroke with poor outcomes and limited treatment improvements from current standard care or traditional surgery. This open-labeled, randomized controlled trial seeks to determine if early endoscopic surgery within 24 hours of bleeding onset can improve functional outcomes at 6 months. Participants are randomly assigned to one of two groups. The intervention group receives BMT plus early minimally invasive endoscopic hematoma evacuation performed within 6 to 24 hours after symptom onset, using advanced imaging and neuro-navigation techniques to guide the surgical procedure. The control group receives best medical treatment alone, which includes strict blood pressure control, seizure prevention, intensive care monitoring, and other guideline-based supportive care. The study involves six visits, with four during hospital stay and two follow-ups as part of routine care. During each visit, assessments include the Glasgow Coma Scale GCS, modified Rankin Scale mRS, and National Institute of Health Stroke Scale NIHSS. Three visits involve CT scans and blood sampling, while other visits assess patient satisfaction, cognition, and quality of life. The primary outcome is functional status measured by mRS at 6 months. Secondary outcomes include mortality rates, cognitive changes, neurological deficits, quality of life, and time spent in intensive care. The trial runs until December 2029 and was designed with patient and public input.

This research evaluates the safety and performance of the Castor and Cratos Branched Aortic Stent Graft Systems for treating thoracic aortic diseases in the descending aorta. The study collects data from around 100 patients in European hospitals to understand how these devices perform in everyday medical practice over short, medium, and long terms. Participants receive treatment with either the Castor or Cratos stent grafts designed to support the aortic arch and left subclavian artery. The study includes both retrospective and prospective data collection, following patients according to each hospitals standard care practices after device implantation. Throughout the study, researchers monitor participants health using measures such as 30-day mortality, technical success within 24 hours, clinical success up to 5 years, rates of complications like endoleaks, branch occlusion, strokes, and reinterventions. Follow-up assessments occur at 30 days, 6 months, and annually up to 5 years, with the entire study lasting until 2033.

This trial focuses on adults with Clostridioides difficile infection CDI, including those experiencing their first episode with risk factors for recurrence or their first recurrence. Researchers aim to compare the effectiveness of fecal microbiota transplantation FMT combined with standard antibiotic treatment against standard antibiotic treatment alone, to prevent further CDI recurrences. This Phase III, randomized, open-label trial addresses an important challenge since recurrent CDI causes significant health problems and reduced quality of life. Participants are randomly assigned to one of two groups. One group receives standard oral antibiotics vancomycin or fidaxomicin for 10 days, followed by FMT capsules administered over two consecutive days patients with severe CDI receive a second FMT over the next two days. The other group continues with the standard antibiotic treatment alone for 10 days. The FMT capsules are prepared from healthy donors and given orally after a brief antibiotic pause. Throughout the study, participants are monitored for sustained clinical cure assessed 8 weeks after treatment completion, with follow-up lasting 12 months. Researchers evaluate treatment failure, new CDI episodes, long-term cure rates, recurrence-free survival, overall survival, and health status using standardized questionnaires. The study aims to gather comprehensive data on the safety and efficacy of FMT combined with standard antibiotics in preventing CDI recurrence.

This trial focuses on children with focal cerebral arteriopathy FCA, a rare but serious condition that causes stroke in childhood. FCA is an inflammatory disease of the blood vessels in the brain triggered by infection. Researchers aim to find out if treating children with high dose steroids plus aspirin leads to better and faster recovery, improved clinical outcomes, and fewer stroke recurrences compared to treatment with aspirin alone. This is a phase 3, randomized controlled study conducted across multiple international centers. Participants will be randomly assigned to one of two groups one group will receive standard care including aspirin plus high dose intravenous methylprednisolone followed by oral prednisolone tapering, while the other group will receive standard care including aspirin without steroids. Steroid treatment is given intravenously for 3 days at 30 mgkgday maximum 1000 mgday, followed by oral prednisolone for 4 weeks with a tapering dose schedule. Treatment begins within 48 hours of diagnosis and no later than 96 hours after stroke onset. Children will be monitored at 1, 3, 6, and 12 months after treatment begins. Evaluations include neurological exams, MRI and MRA imaging at 1, 3 if available, and 6 months, and various outcome assessments such as stroke severity scores, functional measures, cognitive tests, and quality of life questionnaires. Researchers will track recovery, stroke recurrence, and vessel changes to assess treatment effects and safety over the study duration of 48 months.