Publications by authors named "Regina GroSSmann"
Background: Clinical research is marked by its multifaceted nature, presenting a multitude of different approaches, designs, and objectives that can complicate the planning, initiation, and conduct of clinical trials. The role and organisation of the sponsor institution are pivotal in this context. We aimed to investigate possible challenges and needs, including their underlying factors, for academia and industry during the set-up and conduct of clinical trials.
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- Clinicians globally are managing research alongside their regular workloads, leading to the establishment of Clinical Trial Units (CTUs) that support high-quality Investigator Initiated Trials (IITs) and promote international standards.
- The study aimed to identify the critical services that International Clinical Trial Center Network (ICN) members consider essential for effective clinical trial management, contributing to global harmonization.
- Results indicated that services focused on quality management and coordination are prioritized, while operational services are viewed as less critical, suggesting CTUs should enhance their management expertise and training efforts for clinicians.
Article Synopsis
- This study assesses global awareness and actions taken by Academic Research Institutions regarding the reduction of carbon emissions in clinical research.
- Approximately 50% of ARIs either do not consider reducing their carbon footprint in research or are unaware of the issue, while Institutional Review Boards rarely evaluate greenhouse gas emissions in their approval processes.
- Virtual meetings and conferences are the most common approach currently being used across ARIs to address greenhouse gas emissions, highlighting a need for better integration of emissions considerations into research planning.
Introduction And Hypothesis: The purpose was to investigate the safety and feasibility of transurethral injections of autologous muscle precursor cells (MPCs) into the external urinary sphincter (EUS) to treat stress urinary incontinence (SUI) in female patients.
Methods: Prospective and randomised phase I clinical trial. Standardised 1-h pad test, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), urodynamic study, and MRI of the pelvis were performed at baseline and 6 months after treatment.
Objective: Clinical research has faced new challenges during the COVID-19 pandemic, leading to excessive operational demands affecting all stakeholders. We evaluated the impact of COVID-19 on clinical research strategies and compared different adaptations by regulatory bodies and academic research institutions in a global context, exploring what can be learned for possible future pandemics.
Methods: We conducted a cross-sectional online survey and identified and assessed different COVID-19-specific adaptation strategies used by academic research institutions and regulatory bodies.
Background: General Consent (GC) allows the further use of health-related data/samples for multiple, unspecified research projects and/or for the collection in databases and biobanks in Switzerland. The application of General Consent in the context of human research is regulated within the scope of the Human Research Act. At the University Hospital Zurich patients are informed about General Consent to which they can agree (GC = yes) or disagree (GC = no) to the use of their routinely collected data/samples in research.
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- Research projects involving humans are tightly regulated but are evolving with advancements in eHealth and mHealth.
- Patient data is crucial for research, but its protection requires a streamlined consent process that is more adaptable and user-friendly.
- An Android app has been created to facilitate mobile consent forms within hospital systems, but challenges like eIdentification and legal issues are hindering its widespread use.
Cytosolic lipid droplets (LDs) are storage organelles for neutral lipids derived from endogenous metabolism. Acyl-CoA synthetase family proteins are essential enzymes in this biosynthetic pathway, contributing activated fatty acids. Fluorescence microscopy showed that ACSL3 is localized to the endoplasmic reticulum (ER) and LDs, with the distribution dependent on the cell type and the supply of fatty acids.
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