Clinical trials

The MAX-ICH pilot trial is a phase-II study aimed at assessing the feasibility and safety of a comprehensive care bundle for patients with intracerebral hemorrhage (ICH). This "maximal medical treatment" approach combines advanced interventions like intensive blood pressure control, rapid anticoagulation reversal, and tranexamic acid administration to potentially improve outcomes. The primary objective is to evaluate recruitment feasibility over 12 months, while secondary objectives include protocol adherence, safety monitoring, and the exploration of clinical outcomes. The study focuses on the critical first 72 hours of care to determine if this approach can be effectively implemented in clinical practice.

Acute mountain sickness (AMS) is a common condition that can occur when healthy people travel quickly to high altitude. Typical symptoms include headache, nausea, tiredness, dizziness, and poor sleep. In most cases, AMS improves with rest and by not climbing higher, but it can make mountaineering difficult and, in severe cases, can lead to dangerous complications. The biological mechanisms that cause high-altitude headache and AMS are not yet fully understood. Some symptoms of AMS are similar to migraine, suggesting that both conditions may share common pathways in the nervous system. One possible pathway involves calcitonin gene-related peptide (CGRP), a substance known to play an important role in migraine. Fremanezumab is an approved monoclonal antibody used to prevent migraine. It works by binding to CGRP and reducing its biological activity. This study will investigate whether a single dose of fremanezumab can also help prevent symptoms of AMS and high-altitude headache in healthy adults exposed to high altitude. To date, there are no clinical data on the effect of fremanezumab in AMS or high-altitude headache. This is a prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 30 healthy adult volunteers will participate. Participants will be randomly assigned in a 1:1 ratio to receive either a single subcutaneous injection of fremanezumab 225 mg or placebo (saline). Neither the participants nor the investigators will know which treatment was given during the study. The study medication will be administered 1 week before ascent to Capanna Regina Margherita at 4554 meters above sea level. Participants will remain there for 46 hours under hypobaric hypoxic conditions. The main goal is to determine whether fremanezumab reduces the severity of AMS compared with placebo. AMS symptoms will be measured using the Lake Louise Score, a standard questionnaire commonly used in altitude medicine. Additional assessments will include the incidence of AMS, headache characteristics, safety outcomes, vital signs, oxygen saturation, and the use of rescue medication. Symptoms will be assessed repeatedly during the high-altitude stay. Only healthy adults aged 18 to 60 years living below 1000 meters will be eligible. People with important medical conditions, chronic headache or migraine, relevant cardiovascular or lung disease, pregnancy, or recent high-altitude exposure will be excluded. Participants will be closely monitored during the study. Rescue medication, oxygen, and descent to lower altitude will be available if needed. This study may help improve understanding of how AMS develops and whether CGRP blockade could become a new preventive strategy for high-altitude headache and AMS. It may also improve understanding of links between altitude-related headache and migraine.

In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.

The CHAS3 trial studies whether the Stockholm3 blood test can reliably detect if prostate cancer becomes more aggressive in men who are being carefully monitored instead of treated right away (active surveillance). The goal is to see if this test can help doctors safely follow patients with fewer invasive procedures, such as repeated biopsies.

The goal of this clinical trial is to learn if total removal of the pancreas is a preferable alternative to partial removal in patients with cancer of the pancreatic head who are at high risk of pancreatic leakage. The main question it aims to answer is: Does total pancreas removal improve survival without reducing quality of life compared to partial removal? The only study specific procedures are the collection of 2 blood samples (7.5ml for each time point, preoperatively and during the hospitalisation) and the completion of the questionnaires.

The goal of this clinical trial is to learn if a 12-week digitally supported, multimodal home rehabilitation program using the medical application Akina is as effective compared to routine care regarding functional independence in older adults undergoing hip surgery. How is this multimodal home rehabilitation program received by patients? Is this multimodal home program at least as effective in terms of functional indpendence, muscle status, mobility and quality of life compared to routine care? Researchers will compare the multimodal rehabilitation program using the application Akina to routine care to see if the program works to treat patients after hip surgery. Participants will: Undergo the rehab program at home or receive routine care (outpatient physiotherapy) for 12 weeks Visit the clinic after 6 and 12 weeks

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%/year. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is "breakthrough" cardioembolism (76% of patients) and only a minority of 24% is related to other causes unrelated to AF. Optimal secondary prevention strategy is unknown. The investigators have conducted two independent observational studies including together \>4000 patients but did not identify any strategy (e.g. switch to different DOAC, additional antiplatelet therapy) that seems superior. A recent randomized controlled trial on surgical occlusion of the left atrial appendage (LAAO) found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation. Triggered by this finding, the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy (DOAC therapy + LAAO) had lower rates of adverse outcomes compared to those with DOAC therapy alone. Therefore, the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy, LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone. The investigators propose an international, multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology. The investigators will use the PROBE design with blinded endpoint assessment. The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset. Patients will be randomized 1:1 to receive LAAO + DOAC therapy (experimental arm) or DOAC therapy alone (standard treatment arm). The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke, systemic embolism and cardiovascular death during follow-up. Secondary outcomes include individual components of the primary composite outcome, safety outcomes (i.e. symptomatic intracranial haemorrhage, major extracranial bleeding, serious device- or procedure-related complication), functional outcome (modified Rankin Scale) and patient-oriented outcomes. The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study, the maximal follow-up will be 48 months. Based on prior observational data from the investigators' group and others (5 observational studies, \>5000 patients), the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18% in the first year and 9% in the second year (=cumulative 27% after 2 years). A relative risk reduction of 40% at 2 years would be clinically relevant. Based on these assumptions and a log-rank test, the investigators would need 98 events for a power of 80% at an alpha-level of 5%. Assuming a recruitment rate of 52, 118, 156 and 156 patients in years 1 to 4, an additional 6 months of follow-up (mean follow-up time of 2.1 years) and a uniform drop-out rate of 7.5% per year, 482 patients would need to be enrolled. How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma. This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation.

Up to half of patients with pulmonary embolism (PE) suffer from impaired quality of life, reduced physical capacity, and symptoms like shortness of breath even three months after diagnosis, despite standard treatment with anticoagulation (blood thinners). The randomized RehabPE trial investigates whether an early, structured rehabilitation program with physical training and patient education can prevent such long-term effects. The study includes hospitalized patients with acute symptomatic PE who are at increased risk of impaired quality of life three months after diagnosis. After informed consent, patients are randomly assigned to one of two groups: one receives an early 6-8-week, center-based rehabilitation program; the other receives standard follow-up care without rehabilitation. The intervention group completes 16-18 outpatient sessions of endurance and strength training, along with two education sessions covering the condition, treatment, and symptom management. Over 180 days, changes in quality of life, physical exercise capacity, breathlessness, and psychological symptoms, and the time to return to work / usual daily activities will be monitored and compared between groups.

Currently, the estimated number of people with diabetes mellitus is approximately 387 million people worldwide. Due to population growth, urbanization, ageing and the rising prevalence of obesity the numbers of individuals with diabetes is increasing likewise. It has been shown that improving glycemic control is associated with a reduction in late complications of diabetes, such as cardiovascular and microvascular diseases. Therefore, treatment guidelines were established internationally by large and renowned associations and adopted by many countries. For Switzerland only sparse data exist on the actual implementation of such recommendations and on patient's well-being. The Swiss Diabetes Registry - SwissDiab Study is a prospective cohort study aiming at including and collecting data of virtually all patients regularly seen and treated at the study centers (≈ 500 patients each), irrespective of type, duration of diabetes or treatment . This allows the evaluation of diabetes treatment strategies at these centers. Furthermore, risk indicators for micro- and macrovascular complications, mortality as well as costs and quality of life will be assessed. Data will be recorded through an internet-based, electronic database specifically designed for this study. At a later perspective it is planned to extend data collection to general practitioner/family doctor networks in order to include a larger and more representative sample of patients with diabetes in Switzerland.

Sepsis-induced immunosuppression (SIS) is a common complication in patients with septic shock. Reduced expression of Human leukocyte antigen isotype DR (HLA-DR) on circulating monocytes is a marker for SIS and correlates with risk of secondary infections and mortality. The miRSep study aims to improve the understanding of early microRNA (miRNA) mediated changes in HLA-DR on monocytes in patients with septic shock.

Glioblastoma (GBM) remains aggressive despite standard therapy (surgery (CRET) + RT/CT). Over 40% of patients develop recurrence between surgery and pre-RT MRI, with median overall survival (OS) of 13.3m and 24.4m for patients with and without recurrence in pre-RT MRI, respectively. Reoperation is avoided as it delays adjuvant therapy. LITT offers a minimally invasive alternative that may: * Treat recurrence without delaying RT/CT * Potentially sensitize tumors to subsequent therapy This study tests if LITT can be practically integrated within the critical 1-week window between pre-RT MRI and radiotherapy initiation, maintaining the adjuvant schedule.

The aim of this randomized trial with a 2-by-2 factorial design is to test the efficacy of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones. Study interventions: * Empagliflozin 10 mg once daily per os for 36 months * Personalized dietary counseling for 36 months. Control interventions: * Placebo once daily per os for 36 months * Generic dietary counseling for 36 months.

This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease.

The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). The main question it aims to answer is whether it is safe to combine systemic anti-tumor therapy with or without ICI with and bRFA. Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and systemic anti-tumor therapy, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined. Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate.

With this study, the investigators want to investigate whether computerized speech analysis can be used to reliably and objectively detect motor, emotional, and cognitive fluctuations in Parkinson's disease patients.

There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results. The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.

1. Objective and Selection We refer to our research project as the "research project" in this information sheet. If you participate, you will be a participant. In this research project, we aim to investigate the effect of the medication dexmedetomidine on blood pressure during surgery on your carotid artery. We are inviting you because all individuals undergoing carotid artery surgery may participate. 2. General Information Due to your narrowing of the carotid artery, you require a planned procedure under general anesthesia. During this, your circulatory system and heart function will be continuously monitored through ongoing measurements to constantly track your condition. At the start of general anesthesia, heart rate, blood oxygen levels, and blood pressure will be monitored. Strong painkillers and anesthetic agents will then be administered for the general anesthesia. Additional medications will be given to maintain the anesthesia. Your condition will be closely and continuously monitored throughout the general anesthesia. At the end of the surgery, the anesthetic agents will be gradually reduced, allowing you to awaken from the anesthesia. In this context, we want to examine whether the additional administration of dexmedetomidine during carotid artery surgery reduces blood pressure fluctuations that may occur during such anesthesia. The medication dexmedetomidine is approved for the Swiss market by Swissmedic and is commonly used today in many areas of anesthesia and intensive care medicine. It is even administered to pediatric patients in anesthesia. The goal of continuous dexmedetomidine administration during surgery is twofold: to reduce the need for other anesthetic agents while simultaneously minimizing blood pressure fluctuations that may arise during different surgical phases. The scientific question is: Does additional administration of dexmedetomidine influence the intraoperative hemodynamic course and thus the clinical outcome after surgery? The study will be conducted over approximately 24 months at Inselspital Bern (single-center) with 44 patients. We are conducting this study in accordance with Swiss laws and all internationally recognized guidelines. The responsible cantonal ethics committee (KEK Bern, Murtenstrasse, Bern) has reviewed and approved the study. A description of this study is also available on the website of the Federal Office of Public Health: www.kofam.ch. 3. Procedure The planned surgery will be performed independently of this study. Upon the patient's arrival in the operating room, they will be randomly assigned to one of two groups. One group will serve as the control group and receive standard general anesthesia according to our current hospital guidelines. The second group will receive the standard anesthesia plus the study medication dexmedetomidine in a precisely defined dose. Group allocation will be randomized and blinded (not disclosed to participants). The number of patients in both groups will be equal. Both groups will be treated and monitored in accordance with the recommendations and standards of the Department of Anesthesia and Pain Medicine at Inselspital Bern, as well as those of the Swiss Society for Anaesthesiology and Perioperative Medicine (SSAPM). Hemodynamic and cardiac function parameters will be closely monitored and recorded for all study participants. These data will be collected by the attending anesthesiologist. At a precisely defined time point during the surgery (achievement of "burst suppression"), administration of the study medication will be stopped, and anesthesia will be adjusted according to surgical progress. After emergence from general anesthesia, you will be immediately assessed and then transferred to the recovery unit. During your stay on the recovery unit, circulatory parameters and your neurological status will be assessed at regular intervals. Prior to transfer to the regular ward the following day, a questionnaire regarding your neurological status will be completed, and all medications administered during your recovery unit stay will be recorded. The study will then be finished for all participating patients.

Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry (BIOCORE) is a systematic institutional registry on patients undergoing paired CCTA and OCT for validation and development of advanced methods to determine coronary plaque morphology, lesion severity, PCI guidance, and it association with long-term clinical outcomes.

The present project will specifically assess metabolic effects of dietary interventions with controlled intake of fructose and fructose/galactose in GSDI, with the aim to provide evidence whether relaxed dietary restrictions of fructose and galactose may be justified in treatment recommendations at least for adults, which would considerably enlarge food choice in everyday life of the patients with an expected positive impact on the quality of life of patients with this rare disorder.

Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status. As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear. The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).

Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined. The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant. In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events. In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality. The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR. TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.

Limiting perioperative tachycardia (aiming for a heart rate \<90 beats per minute throughout the perioperative period) using the ultra-short acting beta-blocker landiolol in patients with cardiovascular risk factors undergoing major surgery might lower the incidence of perioperative myocardial injury. Feasibility of the intervention needs to be proven prior to conduction of a larger trial.

Treatment for acute traumatic thoracolumbar burst fractures differs significantly across the world in patients without neurological impairments and without damage to the posterior column of the spine. This randomized controlled, non-inferiority clinical trial's goal is to evaluate the effectiveness of surgery versus initial non-surgical treatment for patients with traumatic thoracolumbar spine burst fractures who don't have any neurological symptoms. The study's precise objectives are to: 1. evaluate the clinical outcome (Oswestry Disability Index) 2. evaluate the radiography result (restoration and maintenance of spinal alignment) 3. determine the prevalence of complications at least 24 months of follow-up of neurologically unaffected patients with acute traumatic burst fractures. Both groups will get the same therapy using standardized methods: The surgical group's entire patient population will get combined anterior-posterior (360°) spinal fusion therapy. Three-point hyperextension orthoses will be used to treat all patients in the non-surgical group for six weeks following the injury.

This clinical trial tests whether a patient- and caregiver-completed questionnaire (QUOCCAS) can accurately help identify children and adolescents with cancer who may have an underlying cancer predisposition syndrome (CPS). The study will also evaluate whether providing families with an educational brochure before their clinic visit improves their understanding of genetics and their satisfaction with care. The main questions it aims to answer are: * Does QUOCCAS identify children at risk for CPS as accurately as physician-based tools and compared to genetic testing? * Does the Pre-Visit Preparation (PVP) brochure improve caregiver knowledge about genetics? * Does the PVP brochure improve caregiver satisfaction with the care and information they receive? Participants will: * Complete the QUOCCAS questionnaire about family history, clinical features, and cancer signs * Provide a blood or saliva sample for genetic testing (whole-exome or whole-genome sequencing) * Randomly receive or not receive the educational Pre-Visit Preparation brochure before completing the questionnaire * Complete brief surveys on their knowledge and satisfaction