St Gallen

Researchers are evaluating whether 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 see if this program enhances physical fitness, quality of life, perceived fall risk, self-efficacy, and daily physical activity levels. This trial compares the video-based program to a caregiver-led activation program as an optimized standard care approach. Participants will take part in either the video-based exercise program or the caregiver-led activation program for 12 weeks. Each participant will engage in sessions four times a week, with each session lasting about 20 minutes. The video-based program focuses on mobilization, muscle strengthening, coordination, balance, and relaxation, supervised by a care professional. The caregiver-led activation program is instructed and carried out by care professionals individually or in groups. During the study, researchers will assess participants at baseline, after 12 weeks of intervention, and again 12 weeks after the intervention ends. They will measure physical fitness through tests like the Short Physical Performance Battery, grip strength, and a 2-minute walking test. Secondary measures include health-related quality of life, falls efficacy, self-efficacy, and physical activity tracked with accelerometers. This comprehensive monitoring aims to understand how the programs affect participants over time.

Researchers are working to create and use a comprehensive database focused on intracranial aneurysms IA. This project collects and studies clinical history, imaging data, biological samples, and other information to understand factors linked to the formation and rupture of aneurysms. They aim to identify genetic, environmental, and anatomical markers, as well as evaluate outcomes from different treatment strategies and improve patient care protocols. Participants include patients with diagnosed aneurysms, both ruptured and unruptured, family members of affected individuals, and healthy volunteers. Data collected involves detailed clinical records, imaging scans like MRI angiography and CT angiography, and various biological samples such as blood, cerebrospinal fluid, saliva, and stool. Consent covers access to medical records, use of biological samples, and potential future research uses including genetic analyses. During the study, participants provide health and lifestyle information, imaging data, and biological samples. Researchers will monitor multiple long-term outcomes including disease progression, life expectancy, quality of life, neurological and cognitive status, and treatment effects over periods up to 20 years. Data confidentiality is maintained, and participants can withdraw at any time without affecting their medical care. The study aims to validate disease models and support advances in aneurysm management and research.

Researchers are evaluating the effects of ALN-APP on disease progression in adults with sporadic Cerebral Amyloid Angiopathy sCAA and Dutch-type Cerebral Amyloid Angiopathy D-CAA. This Phase 2 study aims to assess the safety, tolerability, and pharmacodynamics of ALN-APP in these patient groups. The study is sponsored by Alnylam Pharmaceuticals and includes a randomized, double-blind, placebo-controlled design. Participants will receive multiple doses of ALN-APP or placebo administered intrathecally during a 24-month double-blind treatment period. Those who continue into an optional 18-month open-label extension will receive ALN-APP. The study involves two main periods the initial double-blind treatment phase followed by an optional open-label extension. During the study, participants will undergo brain MRIs to measure new cerebral microbleeds and other brain changes. Researchers will also assess cerebrovascular vasoreactivity using functional MRI and measure amyloid precursor protein levels in cerebrospinal fluid. Safety and adverse events will be monitored throughout the up to 50 months of participation, which includes screening, treatment, and safety follow-up.

Researchers are comparing INCA033989 with the best available therapy for adults who have essential thrombocythemia ET with a CALR mutation and have previously received cytoreductive treatment. The study aims to evaluate the effects of these treatments on this specific patient group. It is a Phase 3 clinical trial sponsored by Incyte Corporation to assess treatment responses and safety. Participants will be randomly assigned to receive either INCA033989 administered intravenously or the best available therapy chosen by their doctor. The treatments are given according to the study protocol. The study focuses on treatment outcomes over a period of weeks, including response durability and symptom changes, with assessments at specified timepoints. During the study, participants will have regular visits to monitor their clinical and hematologic responses, symptoms, and any side effects. Researchers will collect data on mutation levels, symptom questionnaires, and fatigue assessments up to 48 weeks. Safety monitoring will continue for 60 days following the last dose. The total duration of participation may extend up to several months as outlined by the trial schedule.

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

Researchers are evaluating whether an individualized physiotherapy program tailored to each persons specific motor deficits can better support physical function compared to usual care physiotherapy in people with Amyotrophic Lateral Sclerosis ALS. This study uses diagnostic assessments with a robotic leg press system to identify muscle function strengths and weaknesses. The aim is to develop safer and more patient-centered physiotherapy strategies for ALS patients. Participants are assigned either to an individualized physiotherapy program or to continue with the usual care physiotherapy. About two-thirds of participants receive the tailored program based on their specific functional deficits, while one-third continue standard therapy following typical clinical practice. The study follows participants over a period of 12 months. Throughout the study, participants will engage in physiotherapy sessions approximately three to five times per week, each lasting about 30 minutes. Researchers will assess physical function using tools like the ALS Functional Rating Scale-Revised ALSFRS-R, focusing on activities such as climbing stairs at six months. The study monitors progress and outcomes to understand how different physiotherapy approaches impact ALS motor function and quality of life.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating a new oral medicine called Inno8 in people with haemophilia A, a condition characterized by low factor VIII activity. The study aims to understand how different doses of Inno8 are processed in the body and to assess its safety. This clinical trial is a Phase 1 study sponsored by Novo Nordisk AS and will last about 11 weeks. Participants will receive oral doses of the study drug NNC0442-0344 A in one of three experimental cohorts. The trial is non-randomized and open-label, meaning all participants receive the study drug without placebo or blinding. The dosing occurs over several days, and the study includes follow-up assessments to monitor drug levels and effects. During the study, participants will have regular assessments to monitor safety and how the drug behaves in the body. Measurements include tracking treatment-emergent adverse events, laboratory tests for blood clotting factors, antibody development, and drug concentration levels at specified times. The total participation duration is approximately 11 weeks, including dosing and follow-up to ensure safety and gather detailed pharmacokinetic and pharmacodynamic data.

Researchers are evaluating Mim8, a new medicine designed to help people with haemophilia A, including those with or without inhibitors. Mim8 aims to prevent bleeding episodes by replacing the function of the missing clotting factor VIII. This long-term study will last up to 5.5 years, ending either when Mim8 is approved in the participants country or by June 2028, whichever comes first. The study includes participants who have been involved in earlier related studies or are new infants with severe haemophilia A. Participants will receive Mim8 as a preventive treatment through subcutaneous injections. Depending on their entry point, participants may use an enhanced cartridge or a DV3407 pen-injector device for administering Mim8. The treatment is given regularly over the study period, with participants potentially receiving up to 262 injections. In the event of bleeding, additional haemostatic medications may be used as agreed with the study doctor. Female participants who are pregnant, breastfeeding, or planning pregnancy during the study are not eligible. During the study, participants will be monitored for any side effects, including injection site reactions and the development of antibodies against Mim8. Researchers will also track bleeding episodes, Mim8 blood levels, and device handling for some participants. Participants and their representatives will complete diaries and questionnaires about their treatment and health. Safety will be carefully followed throughout the study, which may last several years depending on individual enrollment and study progress.

This research aims to compare two surgical approaches for patients experiencing increased intracranial pressure caused by malignant stroke. It investigates whether using a single surgery with an individually molded space-expanding shield can be a viable alternative to the standard decompressive hemicraniectomy followed by a second surgery called cranioplasty. The study is planned as a randomized, controlled, multicenter trial to evaluate these methods in stroke patients aged 18 to under 70. Participants will be randomly assigned to one of two groups. The experimental group will receive decompressive hemicraniectomy with implantation of a space-expanding shield that allows brain swelling while providing protection in a single surgery. The control group will undergo the standard decompressive hemicraniectomy without the shield and later undergo cranioplasty about 90 days after the initial surgery. Follow-up examinations are scheduled at 1 to 7 days, 6 weeks, 3 months, and 6 months after surgery. During the study, participants will undergo evaluations including neurological assessments and imaging to monitor recovery and complications. Researchers will measure outcomes such as the modified Rankin Scale score at 6 months, number of additional surgeries for intracranial pressure control, infections, wound healing, syndrome of the trephined, survival, cosmetic satisfaction, and quality of life. The total duration of participation for each patient is 6 months, with safety and recovery closely monitored throughout.