St Gallen

Researchers are evaluating if the video-based exercise program "Bliib fit - mach mit!" can improve physical fitness in older adults living in residential care facilities. The study aims to find out whether this program enhances physical fitness, quality of life, perceived fall risk, self-efficacy, and daily physical activity levels compared to an optimized standard care activation program led by caregivers. The research focuses on adults with low to moderate fall risk who can physically and cognitively follow exercise instructions. Participants will engage in one of two programs for 12 weeks, attending sessions four times per week, each lasting 20 minutes. The video-based exercise program includes mobilization, muscle strengthening for the lower and upper limbs, coordination, balance, and relaxation exercises. These sessions are supervised by care professionals or registered activation specialists. The comparison group will receive an individually or group-delivered caregiver-led activation program provided by nursing staff as optimized standard care. Throughout the study, researchers will evaluate physical performance using tests such as the Short Physical Performance Battery, grip strength measurement, and a 2-Minutes Walking Test at the start, after the 12-week intervention, and again 12 weeks later to assess long-term effects. Participants' ability to carry out exercises, safety, and overall progress will be monitored by clinical staff. The total participation period includes the intervention and a follow-up phase extending 12 weeks beyond the exercise program.

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.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

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.

Researchers are evaluating the effects of ALN-APP on the progression of cerebral amyloid angiopathy (CAA), a condition affecting blood vessels in the brain. This phase 2 study aims to assess the safety, tolerability, and pharmacodynamics of ALN-APP in adults with sporadic CAA and Dutch-type CAA, a genetic form of the disease. The study includes a 24-month double-blind treatment period followed by an optional 18-month open-label extension to further explore the treatment's effects. Participants receive either ALN-APP or a placebo, both administered directly into the spinal canal (intrathecally). The initial 24-month period is conducted in a double-blind manner where neither the participants nor the researchers know who receives the treatment or placebo. After this, participants may join the open-label extension phase where everyone receives ALN-APP. This design helps to monitor the drug's impact over a long period. During the study, participants will undergo brain scans using magnetic resonance imaging (MRI) to measure new microbleeds in the brain, which are a marker of disease progression. Researchers will also monitor safety and drug effects through various assessments. The total participation time, including screening, treatment, and follow-up, can last up to 50 months, allowing for thorough observation of treatment outcomes and safety.

Researchers are conducting a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab with investigator's choice monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who have incurable metastatic or recurrent disease. This study focuses on patients with progressive disease after anti-PD-1 therapy and platinum-containing therapy and aims to evaluate the treatments as second- or third-line options. Participants will receive either petosemtamab or one of the investigator's choice monotherapies, including cetuximab, methotrexate, or docetaxel. The study involves treatment administration under controlled conditions with monitoring for efficacy and safety. The goal is to assess the treatments over time with a focus on response rates and overall survival. During the study, participants will undergo regular assessments including radiologic imaging to measure tumor response, and evaluations of overall survival up to approximately three years. The primary outcomes include objective response rate assessed by blinded independent central review and overall survival. Researchers will monitor patient health, side effects, and treatment effectiveness throughout the study duration.

Researchers are evaluating whether a personalized physiotherapy program, tailored to each person's unique motor challenges, can better support physical function compared to usual care physiotherapy in individuals with amyotrophic lateral sclerosis (ALS). This study uses a robotic leg press system to guide the individualized program by assessing muscle strength and movement control. The goal is to improve physiotherapy approaches for people with ALS safely and in a patient-centered way. Participants will be assigned to receive either the individualized physiotherapy program based on their specific motor deficits or the standard physiotherapy care. The intervention involves approximately three to five exercise sessions of 30 minutes each per week over the study period. The study follows participants for 12 months to observe outcomes. Throughout the study, participants' physical abilities will be regularly assessed, including their ability to climb stairs measured by the ALS functional rating scale - revised (ALSFRS-R). Researchers will monitor safety and treatment effects over time to understand how each physiotherapy approach impacts physical function in ALS. Participation lasts for the full 12 months of follow-up.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are studying how different doses of a new medicine called Inno8 work in the bodies of people with haemophilia A, a genetic bleeding disorder. The main goal is to determine if Inno8 is safe for use in this group. This is a Phase 1 study, meaning it is an early-stage trial focused on safety and how the body processes the medicine. The study will last about 11 weeks. Participants will receive multiple increasing oral doses of Inno8 during the study. The study drug, known as NNC0442-0344 A, will be given by mouth. The trial will closely monitor the participants as they take the study medicine to observe how their bodies respond to different dose levels. During the study, researchers will track any side effects or adverse events that occur from the first dose until 46 days after dosing ends. Participants will undergo assessments to measure safety and how their bodies handle the medication. The study includes careful monitoring throughout the treatment and follow-up periods to ensure participant safety and collect important data on the medicine's effects.

Malignant cerebral infarction can cause dangerous brain swelling that increases pressure inside the skull. The usual treatment involves removing part of the skull (decompressive hemicraniectomy or DCE) to relieve pressure, followed by a second surgery months later to replace the bone flap or use a substitute (cranioplasty or CP). This study is exploring whether a new approach using a specially molded space-expanding shield implanted during the initial surgery can protect the brain and avoid the risks linked to the two-step process, such as brain exposure and bone resorption. Participants will be divided into two groups: one receiving the standard DCE followed by CP about 90 days later, and the other receiving DCE plus implantation of the space-expanding shield in a single surgery. The shield is designed to allow brain swelling while providing protection, potentially eliminating the need for a second operation. The cranioplasty in the control group may use either the patient's original bone flap or a synthetic PMME bone flap. Patients will be monitored through examinations at 1 to 7 days, 6 weeks, 3 months, and 6 months after surgery. The main outcome measured is the modified Ranking Scale score at 6 months, which evaluates patients’ recovery and function. The study aims to assess whether the shield offers a viable alternative to the traditional two-step surgical approach, with follow-up lasting six months for each participant.