As the continuation and implementation of findings from basic (pre-)clinical research, clinical trials make a significant contribution to medical research. They form the central building block of translational medicine and thus make a decisive contribution to bringing medical knowledge into general care. This helps to make possible a healthcare system that is aligned to the needs of patients and functions efficiently in the long term. Based on the specific objective, clinical trials must comply with national, but increasingly also with European and international regulatory requirements. In academia in particular, expertise in a variety of fields is required in order to make investigator-driven clinical trials a success. This expertise can be provided by a clinical trial center based within the institution conducting the trial.
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NEDD4-Mediated GSNOR Degradation Aggravates Cardiac Hypertrophy and Dysfunction.
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Key Laboratory of Drug Targets and Translational Medicine for Cardio-cerebrovascular Diseases, Key Laboratory of Targeted Intervention of Cardiovascular Disease, Collaborative Innovation Center for Cardiovascular Disease Translational Medicine, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Gusu School, Nanjing Medical University, Jiangsu, China (X.T., X.L., X.S., Y. Zhang, Y. Zu, Q.F., L.H., S.S., F.C., L.X., Y.J.).
Background: The decrease in S-nitrosoglutathione reductase (GSNOR) leads to an elevation of S-nitrosylation, thereby exacerbating the progression of cardiomyopathy in response to hemodynamic stress. However, the mechanisms under GSNOR decrease remain unclear. Here, we identify NEDD4 (neuronal precursor cell expressed developmentally downregulated 4) as a novel molecule that plays a crucial role in the pathogenesis of pressure overload-induced cardiac hypertrophy, by modulating GSNOR levels, thereby demonstrating significant therapeutic potential.
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Pharm Stat
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Division of Biostatistics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Clinical trials (CTs) often suffer from small sample sizes due to limited budgets and patient enrollment challenges. Using historical data for the CT data analysis may boost statistical power and reduce the required sample size. Existing methods on borrowing information from historical data with right-censored outcomes did not consider matching between historical data and CT data to reduce the heterogeneity.
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Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.
A recent study design for clinical trials with small sample sizes is the small n, sequential, multiple assignment, randomized trial (snSMART). An snSMART design has been previously proposed to compare the efficacy of two dose levels versus placebo. In such a trial, participants are initially randomized to receive either low dose, high dose or placebo in stage 1.
View Article and Find Full Text PDFMinimising harms of tight glycaemic control in older patients with type 2 diabetes.
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Department of Anaesthesiology, Pharmacology and Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver.
In older adults with type 2 diabetes (T2DM), tight glycaemic control (HbA1c 7%) can result in more harm than benefit, especially when using insulin or sulfonylureas. Older adults are at higher risk for adverse drug events, especially hypoglycaemia, which may cause falls, confusion and hospitalisations. This Therapeutic Letter evaluates the risks of tight glycaemic control in older adults with T2DM, focusing on deprescribing diabetes medications in those over 65, especially those with multimorbidity and polypharmacy.
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Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan, China.
Cholangiocarcinoma is the second most common primary liver cancer, and its global incidence has increased in recent years. Radical surgical resection and systemic chemotherapy have traditionally been the standard treatment options. However, the complexity of cholangiocarcinoma subtypes often presents a challenge for early diagnosis.
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