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Bruderholz/basel, Switzerland

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  • Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

    Phase

    N/A

    Span

    127 weeks

    Sponsor

    Medical University of Vienna

    Binningen

    Recruiting

  • Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

    Phase

    N/A

    Span

    121 weeks

    Sponsor

    Medical University of Vienna

    Binningen

    Recruiting

  • Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia

    This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers.

    Phase

    N/A

    Span

    242 weeks

    Sponsor

    Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

    Binningen

    Recruiting

  • Extension Study for the Port Delivery System With Ranibizumab (Portal)

    The Transscleral Photocoagulation sub-study (sub-study 1) will evaluate the effectiveness of using transscleral photocoagulation (TPC) with the Iridex laser system to mitigate vitreous hemorrhages secondary to the Port Delivery System with ranibizumab (PDS) implantation procedure in participants with neovascular age-related macular degeneration (nAMD). The sub-study will enroll about 55 participants. The Re-implantation sub-study (sub-study 2) will evaluate the safety of re-implantation with the updated PDS with ranibizumab . Up to 100 participants who previously participated in the main study in the United States will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.

    Phase

    3

    Span

    576 weeks

    Sponsor

    Hoffmann-La Roche

    Basel

    Recruiting

  • A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

    Phase

    3

    Span

    286 weeks

    Sponsor

    Hoffmann-La Roche

    Basel

    Recruiting

  • A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

    Phase

    N/A

    Span

    251 weeks

    Sponsor

    Hoffmann-La Roche

    Binningen

    Recruiting

  • Shunt-dependency After aSAH - Role of Early Hyperglycaemia in CSF and Blood

    Aneurysmal SAH is a haemorrhage into the subarachnoid space associated with high mortality and morbidity. Several factors influence morbidity and therefore outcome after aSAH with HCP being one such factor. Hydrocephalus is a well-known complication after aSAH. It is thought to occur due to arachnoid adhesions as a reaction to the blood in the subarachnoid space, leading to impaired CSF absorption. Hydrocephalus is associated with an increased risk of poor clinical outcome, cognitive disturbance, and decreased functional status[3-5]. As such, HCP is associated with a significant increase in morbidity and mortality in aSAH patients and warrants treatment, preferably early. In acute HCP, diversion of CSF is conducted via insertion of an EVD. Due to the blood in the CSF, a permanent system, such as a VPS, is not inserted in the early stages as it would get blocked due to clots. If patients cannot be weaned from the EVD due to persisting HCP a VPS, is then inserted if the CSF is not too bloody anymore. Incidence of aSAH-associated HCP is up to 67%, of which about 50% end up needing a VPS. Several risk factors (ie. increased age, female sex, rebleeding, intraventricular haemorrhage, Fisher grade, and Hunt and Hess grade) have been reported. One factor, especially interesting due to its potential target as a treatment option, is hyperglycaemia. Hyperglycaemia after aSAH is common and most likely due to humeral activation including catecholamine release altering homeostasis. Previous studies have reported an association between hyperglycaemia and VPS dependency. The pathophysiological mechanism behind this potential association remains unclear but is likely due to it adhesions caused by hyperglycaemia and therefore reduction of CSF outflow potentially through higher viscosity. Inflammation, disruption of immune function and disruption of endothelial function might also play a role by decreasing reabsorption. The aim of this study is to evaluate the association of glucose levels in CSF, as well as serum (as CSF glucose is proportional to blood glucose), at prespecified time points and its association with VPS dependency in patients requiring EVD. In this step, timing of VPS insertion is going to be conducted as per our standard. Assessment of early (without trying out repeated weaning) versus late VPS insertion will only be evaluated once the association has been proven in our study.

    Phase

    N/A

    Span

    184 weeks

    Sponsor

    Isabel Hostettler

    Basel

    Recruiting

  • Carbon Footprint Assessment for Robotic, Laparoscopic and Open Colorectal Operations to Enhance Environmental Sustainability

    Background Effective reduction of greenhouse gas (GHG) emissions as the key driver for climate change has to be the primary target of sustainable economics in the 21st century . The carbon footprint is calculated by the direct and indirect attributable GHGs emitted during a process, production cycle, or from an institution, such as a hospital.[1] The main metric for calculating the carbon footprint is the CO2 equivalent (CO2eq). In Switzerland, about 6-7% of all CO2 emissions come from the healthcare system. Most CO2 emissions come from hospitals, followed by medical treatments. A large contributor to hospitals' carbon footprints are operating rooms. The high energy demand, anesthetics, and the production of single-use devices and instruments are significant climate-related hotspots in the operating field. However, the life cycle assessment (LCA) varies considerably based on factors such as the type and modality of the operation, among other variables. To date, only a few direct comparisons of the climate impact between surgical modalities, such as open, laparoscopic, and robot-assisted procedures, have been studied. In this study, the investigators aim to compare the three modalities of visceral operations and their impact on the carbon footprint. As previously mentioned, a major component of the high GHG production in operating rooms is the high energy demand and needed resources. The best method to calculate the climate impact is the use of LCA. Within an LCA, climate-related hotspots can be identified for each operation analyzed, which can provide possible ideas to reduce the carbon footprint of operating rooms and their impact on climate change. Methods For this comparison, the investigators will conduct an LCA for each operation observed and compare it among the three different modalities: robotic, laparoscopic and open colorectal procedures. The LCA includes direct and indirect GHG emissions throughout a product's lifetime, as well as energy consumption during the operation. This encompasses the raw materials used, emissions during production and transportation, and the accumulated waste. A life cycle inventory (LCI) collects LCAs for all instruments and products used during the procedure and during preparation. Used surgical instruments, drapes, gloves and gowns will be registered in the prefabricated datasheet during the observed colorectal operation. Single-use equipment recorded in the datasheet will be weighed individually before usage. During the procedure the investigators will then identify not used and used materials and instruments. Their packaging will be weighed after the operation to differentiate between packaging and absolute weight of used instrument. Using the manufacturer's information about raw material usage in each product, the investigators will calculate the CO2 footprint of the individual instruments and materials. In the Ecoinvent database with recorded CO2 emissions per kilogram of raw material will provide the necessary information to conduct LCAs for each product used in the operating room. This study will include sterile as well as non-sterile equipment used during preparing and performing the procedure. For reusable instruments, the investigators will estimate the total CO2 footprint, including the sterilization process, using average values from previous studies. Reusable instruments used for robotic operations is estimated to have a life span of around 10 to 15 sterilization processes. The estimated life cycle for laparoscopic reusable instruments is set to be around 100 sterilization processes. Other reusable surgical instruments that are commonly used are estimated to live up to 1000 sterilization cycles. During the procedures the investigators will identify the majority of not used but prepared instruments. Additionally to the materials and instruments the investigators will record the used anesthetics for general anesthesia and with previous study calculate the estimated climate impact For the secondary research question the investigators will differentiate between used, opened and prepared equipment in the operating room during the procedure. The research team will therefore additionally identify material and instruments that were unpacked but not used during the procedures It is important to state, that only used and opened instruments and materials will be included in the calculation of the CO2 footprint. To calculate the energy used during the operations, the kilowatt hours (kWh) needed during the procedure itself will be extracted as average energy consumption in the operating room where the surgery took place. The investigators will then calculate the CO2 footprint using information about the clinic's energy mix. Additionally, the research team will use standardized calculations for the CO2 footprint of anesthesia and hospital stay to estimate the value for the observed operations. The raw data will be collected in an REDCAP database and further analyzed with the software SimaPro or OpenLCA. The investigators then estimate the related CO2 footprint per procedure. The mean CO2 footprint will afterwards be used to compare the three modality. For comparisons between groups, the research team will use the Mann-Whitney U test in R and RStudio. Climate impact will be estimated using the ReCiPe method. Target The aim of the LCA robotic operation study is to compare the carbon footprint between robotic, laparoscopic and open colorectal procedures and to identify major targets for the reduction of CO2 emissions.

    Phase

    N/A

    Span

    42 weeks

    Sponsor

    University Hospital, Basel, Switzerland

    Basel

    Recruiting

    Healthy Volunteers

  • Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in Healthy Participants

    Lysergic acid diethylamide (LSD), psilocybin, and N,N-dimethyltryptamine (DMT) are serotonergic hallucinogens (psychedelics) and currently investigated as therapeutic tools for the treatment of various psychiatric disorders. They are usually administered in a dose range which induces an alteration of consciousness via the stimulation of the serotonin (5-HT)2A receptor. However, there are differences in the receptor activation profiles between the three substances that may induce different subjective effects. Moreover, they exhibit different pharmacokinetic qualities. In comparative studies of LSD and psilocybin blinding was impaired by the different duration of subjective effects. This study aims to ensure blinding by ending all experiences at the same time with the 5HT2A antagonist ketanserin. Moreover, no study has yet directly compared DMT to LSD and psilocybin. The DMT infusion will be modeled in accordance with the course of an oral LSD and psilocybin administration. Therefore, the LPD-study compares the acute and subacute effects of LSD, psilocybin, and DMT while standardizing the time course and the duration of action for all substances.

    Phase

    1

    Span

    70 weeks

    Sponsor

    University Hospital, Basel, Switzerland

    Basel

    Recruiting

    Healthy Volunteers

  • Testing the Implementation of a Toolbox to Optimize Data Collection and Data Quality of the National Medical Quality Indicators in Long-term Care Facilities: a Pilot Study. (NIP-Q-UPGRADE Subaim 1.8)

    A one-group experimental study will be performed including a multiple methods evaluation. Participants will be recruited at two levels: - the provider responsible for delivering the training to the champions from the long-term care facilities, - long-term care facilities who will implement the data quality development toolkit and select the champions to be sent to the training. The external training provider is a company with experience in training staff of long-term care facilities in performing needs assessment with residents and in understanding and using the current MQI. The company will nominate employees to be instructed by the research team (December 2024) on how to conduct the developed training for facility champions. They will take up the organization and conduct of the trainings in three languages all regions of Switzerland. The research team will inform the training participants about the study and the data collection. At facility level, five to ten long-term care facilities per Swiss language region (German, French and Italian speaking) will be recruited between November and December 2024 to implement the data quality development toolkit (i.e., a max. of 30 facilities in total over all language regions). At least one person per facility will be trained between January and March 2025 to act as a champion in the data quality development toolkit and perform tasks such as training of fellow staff and data quality monitoring (1 full day training onsite, two online trainings of 4h, resp. 2h with 2-4 weeks in-between). Trainings will be language-specific. Individual study participants will be persons involved in delivering and coordinating champion trainings. In long-term care facilities we aim to collect data from the champions, the direct care staff at different educational levels, management staff and staff responsible for quality in the facilities. All individual participants will be asked to consent for data collection. Data will be collected between November 2024 and June 2025: At the training provider level Quantitative data: Activity logs: The costs of organizing and delivering the trainings will be assessed by using activity logbooks filled in continuously by the staff organizing and conducting the training (November to March 2025) Qualitative data: Interviews or group discussion: Acceptability, feasibility, fidelity, and adaptations to the toolkit, and barriers and facilitators to the implementation of the champion training will be assessed through interviews or group discussions with the involved staff after each of the three training session (January to March 2025, in total 9 interviews or group discussions, 3 per language region). At the long-term care facility level Quantitative data: Online survey: Acceptability, feasibility and fidelity will be assessed via online surveys of involved staff at different levels (e.g., nurses, nurse assistants, management, champions) in March 2025. The surveys will also ask for background information on the facilities and participants. Survey data will be collected in a secure online electronic data collection platform (REDCap). Activity logbooks: Costs associated with the implementation will be assessed by using activity logbooks filled in by the champions and management. Qualitative data: Focus groups: Acceptability, feasibility, fidelity, and adaptations to the toolkit, and barriers and facilitators to implementation will be assessed through focus group per language region per staff group coming from different facilities: 1. 1-2 focus groups with management staff and staff responsible for quality (March 2025, total over all language regions 3-6 focus groups). 2. 1-2 focus groups with champions (March 2025 and June 2025, over all language regions 3-6 focus groups per time point, 6-12 in total) 3. 1-2 focus groups with nurses and care staff exposed to the toolkit (March 2025, total over all language regions 3-6 focus groups)

    Phase

    N/A

    Span

    30 weeks

    Sponsor

    University of Basel

    Basel

    Recruiting

    Healthy Volunteers

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