Zurich

Researchers are evaluating a new treatment approach for meningiomas that continue to grow despite local therapies like surgery and radiotherapy. This trial focuses on the precision medicine concept of combining molecular imaging for patient selection with targeted treatment using a radioligand called 177Lu-DOTATATE. The study builds on evidence showing high expression of somatostatin receptors in meningiomas and prior success of this radioligand therapy in other tumors, aiming to explore its use in refractory meningiomas in a randomized Phase II study. Participants are randomly assigned to receive either the investigational treatment 177Lu-DOTATATE given by intravenous injection or the local standard of care, which may include treatment or observation as decided by their doctor. The trial involves baseline PET imaging to confirm somatostatin receptor positivity and follows patients after treatment. This design allows researchers to compare the effects of the new therapy against current practices in managing recurrent meningioma. During the study, participants undergo assessments including cranial MRI scans to measure tumor status and PET imaging for receptor evaluation. Blood tests are performed to monitor organ function and electrolytes before and during treatment. The main outcome measured is progression-free survival, tracking the time from randomization until disease progression or death, with follow-up for up to two years. Safety and treatment adherence are closely monitored throughout the study period.

High-resolution 7 Tesla MRI is used to study the cervical spine by providing clear images that differentiate nerve structures from surrounding tissues within the foramina. This imaging allows precise measurement of nerve roots and ganglia diameters. The study also examines the detailed anatomy of the vertebral artery and its relationship to nearby neural structures and foramina. Participants will undergo a 7 Tesla MRI scan, a diagnostic test that offers enhanced imaging of the spine. This study includes both individuals with chronic back pain lasting more than two months and asymptomatic participants to help depict normal microanatomy. The focus is on evaluating the nerve root and ganglia sizes in the cervical spine region. During the study, researchers will measure standard values such as the diameter of nerve roots, ganglia, and neuroforamina at each spinal segment over one year. Participants will provide informed consent before joining, and any contraindications to MRI will be carefully considered. This research aims to improve understanding of spinal anatomy through advanced imaging techniques.

Researchers are working to create a comprehensive reference database focused on intracranial aneurysms (IA). This project aims to gather detailed clinical history, imaging data, biological samples, and other related information to better understand risk markers for aneurysm formation and rupture, along with prognostic factors for different management strategies. The study also seeks to develop patient-specific management protocols and assess how the database and its tools can improve care, reduce costs, and support new discoveries and industrial developments. Participants include patients with newly diagnosed or known intracranial aneurysms, healthy volunteers, and family members of patients with a familial history of IA. Data collected includes demographic details, medical history, imaging scans such as MRI angiography and CT angiography, and various biological samples like blood, cerebrospinal fluid, saliva, and stool. Participants are asked to provide consent for data and sample use, including genetic analysis and potential future research applications. There are no limits on the number of participants for this database. During the study, participants will provide access to their health records, complete questionnaires, and undergo imaging and sample collection. Researchers will track clinical outcomes, imaging results, and quality of life measures over time. The primary outcome is disease model validation over 5 years. Consent includes provisions for confidentiality, withdrawal without impact on care, and possible re-contact for additional information or consent. The study ensures safety through ethical oversight and insurance coverage for any direct harm related to participation.

Researchers are investigating how electromagnetic fields (EMFs) from 5G technology affect sleep-related brain health, focusing on people who carry a specific genetic variant of a brain protein called CaV1.2. This protein controls nerve cell activity through calcium channels and might play a role in how 5G impacts sleep. The study aims to see if blocking CaV1.2 with the drug nimodipine can reduce or stop the effects of 5G EMF on sleep in healthy adults aged 20 to 40. Participants will undergo a genetic screening to select those carrying the target gene variant. The study includes a screening sleep night and four experimental nights where participants are exposed to either a real 5G field or a sham (fake) field. Before exposure, they receive either nimodipine capsules or placebo pills twice, 45 minutes before the 30-minute 5G or sham exposure. The study uses a double-blind design so neither participants nor researchers know who receives the drug or placebo. During the study, participants will have overnight sleep recordings using electroencephalography (EEG) to measure brain activity, including sleep spindle frequencies. They will also undergo cognitive and mental health assessments and have various physical measurements taken. Researchers will analyze the effects of 5G and nimodipine on sleep characteristics, with a washout period of at least three days between each experimental night to ensure clear results.

Researchers are evaluating the MammoWave device, which uses low-power microwaves instead of X-rays for breast cancer screening, in a large population of 10,000 women undergoing regular breast cancer screening programs. The study aims to confirm that MammoWave can achieve sensitivity greater than 75% and specificity greater than 90% in detecting breast cancer. This investigation is part of the MammoScreen project and involves multiple centers in Europe. Women participating in the study will first undergo a brief visit to check eligibility and review medical history. They will then have the MammoWave exam on both breasts, which includes an 8-minute data acquisition phase while lying prone on the device's bed, followed by data processing using specialized microwave imaging algorithms. The device will generate microwave images and classification results indicating the presence or absence of suspicious breast lesions. Participants will continue with their conventional breast screening examinations, such as mammograms, which serve as the reference standard for comparison. The study will monitor MammoWave's sensitivity and specificity during the procedure. Women aged 45 to 74 with average breast cancer risk and no symptoms are eligible, and the study excludes those with breast prostheses, prior breast cancer, certain genetic risks, pregnancy, or breast sizes too large for the device. The overall participation involves coordinating MammoWave testing with routine screening appointments and consenting to study procedures.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

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 evaluating sotatercept as a potential treatment for pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and overworking the heart. PAH symptoms include difficulty breathing and reduced ability to be active. Current standard treatments address symptoms but do not stop disease progression. This Phase 3 study focuses on the long-term safety and tolerability of sotatercept when added to standard PAH therapy. Participants in this long-term follow-up study receive sotatercept through subcutaneous injections every three weeks. Only individuals who completed prior sotatercept PAH studies without early discontinuation may join. This study continues the observation and assessment of participants over an extended period to learn about the effects and safety of sotatercept combined with background PAH treatments. During the study, participants will be regularly monitored for adverse events, treatment discontinuations, and the presence of anti-drug antibodies for up to approximately 90 months. Laboratory tests will evaluate blood components such as platelets, hemoglobin, creatinine, bilirubin, and liver enzymes. Changes from baseline in body weight, blood pressure, and electrocardiogram readings will also be tracked. The study involves adherence to visit schedules and compliance with study procedures to ensure comprehensive long-term safety data collection.

Researchers are evaluating a new classification system for obstructive sleep apnea (OSA) in adults who have recently been diagnosed with this condition. The study aims to monitor long-term improvements both objectively and subjectively in patients with OSA. It focuses on patients who have a diagnosis confirmed by sleep studies and tracks changes in symptoms and cardiovascular measures over time. The study does not involve experimental treatments but observes participants over a period of up to 36 months. During this time, the classification system is applied, and patients are followed to assess changes related to sleepiness and blood pressure. The study is prospective and observational, meaning it follows patients forward in time without assigning specific treatments. Participants will be assessed at enrollment and monitored throughout the observation period. Key measurements include changes in daytime sleepiness using the Epworth Sleepiness Scale and changes in office systolic blood pressure. The study collects data to understand how the new classification relates to patient outcomes over three years, ensuring safety and adherence through regular follow-up visits and evaluations.

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly injection under the skin, in people with mild to moderate calcific aortic valve stenosis. This study aims to see if pelacarsen can safely slow the progression of this heart valve condition compared to a placebo. The trial is a phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. Participants will receive either pelacarsen 80 mg or a matching placebo once a month. Before starting the treatment, they must have elevated lipoprotein(a) levels and be optimally treated for existing cardiovascular risk factors. The study focuses on those aged 50 to under 80 years with mild or moderate calcific aortic valve stenosis. During the 36 months of participation, researchers will monitor changes in peak aortic jet velocity and aortic valve calcium score to assess disease progression. Safety, tolerability, and the impact of the treatment will be evaluated. Participants will undergo regular assessments, including laboratory tests and clinical evaluations, to track heart valve condition and overall health throughout the study.