Bern

Researchers are studying patients with gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux disease to identify typical changes in their voices. Reflux occurs when gastric juice flows back into the esophagus and throat, causing symptoms like heartburn, acid regurgitation, throat irritation, hoarseness, and coughing. The study aims to see if voice samples can detect reflux disease as an easy, safe, and low-cost initial test by analyzing vocal patterns that might be altered by the reflux. Participants will provide voice recordings using a microphone and complete a questionnaire. The study includes two groups: patients with confirmed reflux and those without reflux. Voice samples from 47 participants in each group are compared. Additionally, patients with reflux will have a second voice recording five months after starting treatment to assess changes over time. The recordings are digitized and analyzed in collaboration with a Swiss technology center to identify vocal biomarkers typical for GERD. Participants undergo standard reflux diagnostic tests including gastroscopy, esophageal manometry, and 24-hour impedance pH measurement before enrollment. Throughout the study, voice samples and questionnaires are collected without requiring extra hospital visits. Data is securely stored and results are expected by 2025. The total study duration for participants is up to five months, focusing on identifying voice patterns linked to reflux and monitoring changes after treatment.

Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Researchers are investigating new treatments for advanced ovarian cancer, specifically in patients who do not have homologous recombination deficiency (non-HRD positive). This Phase 3 study aims to assess whether maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, can improve progression-free survival compared to the current standard care after initial platinum-based chemotherapy and surgery. Participants receive sacituzumab tirumotecan through intravenous infusion at a dose of 4 mg/kg. Some also receive bevacizumab intravenously at 15 mg/kg as part of their maintenance treatment. Before sac-TMT infusion, participants are given prophylactic steroid mouthwash and recommended rescue medications including histamine-1 and histamine-2 receptor antagonists, acetaminophen or equivalent, and dexamethasone or equivalent. The study compares these treatments to standard care or observation following first-line chemotherapy. During the study, participants are monitored for progression-free survival for up to approximately 49 months. Researchers will assess how long participants live without their cancer getting worse. Throughout the trial, safety and response to treatment are evaluated. The study includes women aged 18 years and older who have completed surgery and first-line chemotherapy with specific responses and meet certain health criteria.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating the effectiveness and safety of Xeomin injections in preventing chronic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections given into muscles of the head and neck. Participants have chronic migraine diagnosed for at least 12 months and meet specific headache and migraine day criteria. The study aims to measure changes in monthly migraine days over time with Xeomin treatment. Participants will receive four treatments spaced about 12 weeks apart over a total study duration of 52 to 55 weeks. The treatments involve injections of either Xeomin or placebo solution prepared with sodium chloride. Visits occur approximately every 4 weeks, totaling 14 visits: the first, last, and four treatment visits are on-site, while the other eight visits are remote via phone or video call. During the study, participants will keep headache diaries to track migraine and headache days. Researchers will focus on the change in monthly migraine days from baseline to six months after the first injection. Safety and effectiveness are monitored throughout, with frequent assessments during both on-site and remote visits to ensure accurate tracking of migraine symptoms and any side effects.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing episodic migraine. This phase 3 clinical trial focuses on adults who experience episodic migraine, aiming to measure changes in the number of migraine days per month. Participants must have a diagnosis of episodic migraine for at least 12 months and meet specific headache frequency criteria. Participants will receive four treatments of either Xeomin or placebo injections into muscles of the head and neck, with treatments spaced about 12 weeks apart. The entire trial lasts approximately 52 to 55 weeks, beginning with a screening period of 4 to 5 weeks. There are about 14 visits in total, with the first, last, and four treatment visits conducted on-site, while the other visits are held remotely via phone or video. Throughout the study, participants will track their migraine days using a headache diary, and researchers will assess changes in monthly migraine frequency from baseline to six months after the first injection. Regular monitoring includes both in-person and remote assessments. The primary outcome focuses on the change in monthly migraine days between baseline and month six after treatment initiation.

Giant cell arteritis (GCA) is a common systemic vasculitis affecting elderly people. This trial aims to evaluate the effectiveness of AzaFol-PET/CT imaging in diagnosing GCA by comparing it with the current standard imaging method, 2-[18F]FDG-PET/CT. The study also assesses the safety and tolerability of AzaFol in patients suspected of having GCA. Activated macrophages in inflamed vascular tissue express folate receptor beta, which AzaFol targets, potentially improving the ability to distinguish vasculitis from atherosclerosis. Participants will undergo AzaFol-PET/CT imaging once during the study. The trial compares AzaFol with FDG through PET/CT scans to assess their diagnostic accuracy. This is an open-label, phase II clinical trial conducted at a single center. There are no additional treatment phases or long-term interventions described. During the study, participants will have PET/CT scans performed to capture images of vascular inflammation using both AzaFol and FDG tracers. Researchers will measure the specificity of the GCA diagnosis at baseline using these imaging methods. Participants must be able to remain still and comply with fasting and imaging procedures. Safety and tolerability of AzaFol will be monitored, and participants' adherence to study protocols will be ensured. The study focuses on patients aged 50 years and older with suspected GCA.

Researchers are studying people aged 50 and older with Covert Brain Infarcts (CBIs), which are small brain injuries found by chance on MRI scans. These brain infarcts do not cause symptoms initially but are linked to a higher risk of future strokes and death. The study aims to find out if treatments that prevent strokes, such as blood-thinning and cholesterol-lowering medications, can help people with CBIs. It will also explore whether having CBIs increases the risk of dementia and if treatment can reduce that risk. This is a Phase 3 randomized trial conducted in multiple centers across Europe. Participants will be randomly assigned to receive stroke-preventing treatments including daily doses of acetylsalicylic acid (75-100 mg), clopidogrel (75 mg), rosuvastatin (starting at 10 mg daily with possible increase to 20 mg), or atorvastatin (40 mg daily with possible reduction to 20 mg if not tolerated). The treatments are given orally and are studied either alone or in combination to evaluate their effects on preventing future vascular events in people with CBIs. During the study, participants will be monitored for major adverse cardiac and cerebral events as well as major and fatal bleeding at 12 and 36 months after starting treatment. Researchers will perform evaluations and track outcomes related to stroke prevention and safety. The total participation period includes follow-up visits over three years to assess the long-term effects and risks associated with these treatments.

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.