Geneve

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 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 investigating sacituzumab tirumotecan (MK-2870) alone or combined with other treatments to treat certain gastrointestinal cancers. These include colorectal cancer that cannot be removed by surgery or has spread, advanced pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and measure how many participants respond to the treatment by having their cancer shrink or disappear. Participants may receive sacituzumab tirumotecan by intravenous infusion alone or with other anticancer drugs such as fluorouracil (5-FU), leucovorin or levoleucovorin, cisplatin, and pembrolizumab. Rescue medications like diphenhydramine, H2 receptor antagonists, acetaminophen, dexamethasone, and a steroid mouthwash are given to prevent infusion reactions and oral side effects. Supportive care treatments for side effects, including antidiarrheal and antiemetic agents, are allowed throughout the study. During the study, researchers monitor participants for dose-limiting toxicities within about 4 weeks and track adverse events, treatment discontinuations, and tumor response over up to approximately 63 months. Assessments include safety evaluations and measuring cancer response using standardized criteria. This long-term follow-up helps evaluate both the effectiveness and safety of the treatments being studied.

Researchers are evaluating if ifinatamab deruxtecan (I-DXd), an antibody-drug conjugate that attaches to proteins on cancer cells to deliver treatment, can treat esophageal squamous cell carcinoma (ESCC). This Phase 2 open-label study aims to find out how many participants experience a reduction or disappearance of their cancer after receiving I-DXd. The trial is part of the KEYMAKER-U06 master screening protocol and focuses on patients with advanced or metastatic esophageal cancer who have already had prior treatments. Participants receive I-DXd through intravenous infusion, and rescue medications including 5-HT3 receptor antagonists, NK-1 receptor antagonists, and corticosteroids may be given according to approved guidelines to manage side effects. The study includes those with unresectable locally advanced or metastatic ESCC who have progressed after one or two previous systemic therapies. The study does not specify a maximum age limit but requires participants to be adults. During the study, researchers will monitor participants for up to approximately 15 months to measure the objective response rate, which means how many participants show cancer shrinkage or disappearance. Participants will undergo assessments to confirm diagnosis, measure disease progression, and monitor organ function. Safety will be closely observed, including monitoring for infections, cardiovascular issues, lung diseases, and other health conditions that might affect treatment. The goal is to better understand the treatment's effects and safety profile in this patient population.

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 whether adding the antibiotic fosfomycin to ceftazidime (or ceftazidime-avibactam when resistant bacteria are suspected) improves outcomes for adults hospitalized with severe suspected Gram-negative bacterial infections. This Phase 3 trial compares the combination therapy to ceftazidime alone to see if the addition leads to faster recovery, measured by quicker normalization of organ function scores and reduction in inflammation markers, as well as to assess the safety of this combination. Participants will be randomly assigned to one of two groups: the intervention group will receive intravenous ceftazidime (with avibactam if resistant bacteria are suspected) plus fosfomycin, while the control group will receive ceftazidime (with avibactam if needed) plus a placebo. Treatments will be given three times daily for three days or less often, depending on kidney function. Dosages and administration methods will be adjusted as needed, and physicians will decide on the use of continuous infusion and avibactam based on clinical judgment. During the study, participants will provide extra blood samples to measure inflammation levels using C-reactive protein (CRP). Researchers will monitor the time until organ failure scores normalize and CRP levels drop by half. Follow-up will occur up to 28 days, including hospital visits or phone calls to ask health-related questions. The study estimates median recovery times of approximately 4 to 5 days in each group.

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.

Low back pain is a leading cause of disability worldwide and a common reason for visits to primary care. This research evaluates the effectiveness of a new multilevel care approach designed to improve how general practitioners manage low back pain. The study involves over 100 general practitioners in French-speaking Switzerland and aims to improve patient outcomes, reduce unnecessary imaging, and assess cost-effectiveness through a cluster randomized controlled trial comparing the new intervention to usual care. The multilevel intervention includes training for general practitioners to improve their confidence and adherence to guidelines, regular email reminders, patient education to address unhelpful beliefs, and a clinical care pathway tailored to patient risk levels. This pathway involves education, self-management, individual physiotherapy sessions, and multidisciplinary group management when needed. Physiotherapists receive specialized training, and occupational therapists provide assessments and tailored education for patients requiring multidisciplinary care. The intervention group receives these supports, while the control group continues usual treatment without additional training or resources. Participants are monitored over 12 months with questionnaires at multiple time points and administrative data collection. Outcomes measured include patient-reported disability, imaging rates, quality-adjusted life years, pain intensity, work participation, and practitioner prescribing behaviors. The study also explores how well the intervention is accepted and adopted by healthcare providers and patients via interviews and focus groups. Data analysis will consider clustering and aim to detect meaningful improvements in disability and cost-effectiveness.

This research aims to evaluate the safety and effectiveness of two dose levels of anvumetostat, a film-coated tablet, in participants with advanced non-small cell lung cancer (NSCLC) that has a specific genetic deletion called MTAP. The study is a Phase 2 trial focusing on participants who have previously been treated for their advanced NSCLC. It also assesses the treatment's effect through independent blinded review to better understand its impact on the cancer. Participants receive anvumetostat as a monotherapy, with dosing schedules tracked closely. The study includes detailed monitoring of drug levels in the blood at various times during treatment cycles to understand how the medicine is absorbed and processed. Treatment continues through several cycles, with specific days designated for blood sampling to measure drug concentration and timing. During the study, participants will be regularly assessed for tumor response using CT or MRI scans according to established criteria (RECIST 1.1). Researchers will also monitor the occurrence of any side effects or adverse events related to the treatment. The study period for measuring outcomes extends up to 35 months, allowing for long-term observation of safety, treatment response, and drug behavior in the body.