Embracing Generative Artificial Intelligence in Clinical Research and Beyond: Opportunities, Challenges, and Solutions.

To explore threats and opportunities and to chart a path for safely navigating the rapid changes that generative artificial intelligence (AI) will bring to clinical research, the Duke Clinical Research Institute convened a multidisciplinary think tank in January 2024. Leading experts from academia, industry, nonprofits, and government agencies highlighted the potential opportunities of generative AI in automation of documentation, strengthening of participant and community engagement, and improvement of trial accuracy and efficiency. Challenges include technical hurdles, ethical dilemmas, and regulatory uncertainties.

Aquacel Ag Advantage/Ag+ Extra and Cutimed Sorbact in the management of hard-to-heal wounds: a cohort study.

Objective: To compare Aquacel Ag Advantage/Ag+ Extra (Aquacel Ag+) (Convatec, UK) and Cutimed Sorbact (Sorbact) (Essity, US) dressings indicated for the treatment of patients with venous leg ulcers (VLUs), diabetes foot ulcers (DFUs) and pressure injuries (PIs) for clinical performance and outcomes using real-world evidence in Germany and the US.

Method: This study was a chart audit review of patients who used either Aquacel Ag+ or Sorbact dressings in the 24 months prior to October 2022. Healthcare providers with access to electronic medical records and charts were asked to capture data via patient record forms.

Impact of Infusion Set Materials and Designs on the Subcutaneous Response in People With Diabetes: A Rapid Review of the Literature.

Insulin infusion sets (IISs) are an integral and intricate part of continuous subcutaneous insulin infusion for subjects with type 1 diabetes, infusing insulin from pump to the subcutaneous space. Insulin infusion sets interface with the skin surface, the dermis, and the subcutaneous space and may be the cause of infusion failure due to biological events or mechanical problems. Novel IISs with extended wear time and anti-inflammatory properties to mitigate these issues are described in the literature although material-tissue interactions are poorly understood.

Flash glucose monitoring in type 2 diabetes managed with basal insulin in the USA: a retrospective real-world chart review study and meta-analysis.

Introduction: Evidence supporting use of continuous glucose monitoring in type 2 diabetes treated with basal insulin is unclear. This real-world study aimed to assess the impact on glycated hemoglobin (HbA1c) of flash glucose monitoring use in adults with type 2 diabetes managed with basal insulin.

Research Design And Methods: Medical records were reviewed for adult individuals with type 2 diabetes using basal insulin for ≥1 year with or without additional antihyperglycemic medication, HbA1c 8.

Fast Acting Insulin Aspart Compared with Insulin Aspart in the Medtronic 670G Hybrid Closed Loop System in Type 1 Diabetes: An Open Label Crossover Study.

This is a single-center randomized open label active-controlled crossover trial comparing efficacy and safety of fast acting insulin aspart (FA) (FIASP) versus insulin aspart (IAsp) (NovoLog) when used in the Medtronic 670G system in auto mode in patients with type 1 diabetes. Forty patients were randomized to either IAsp or FA. Each treatment period was 7 weeks and a standardized meal test was administered 6 weeks after the start of each treatment period.

Telemedicine During the COVID-19 Crisis and Beyond.

On March 18, as the COVID 19 crisis accelerated, we converted overnight to "seeing" our patients by video. Our journey into telemedicine was abrupt, and there was a steep learning curve.

Anatabine supplementation decreases thyroglobulin antibodies in patients with chronic lymphocytic autoimmune (Hashimoto's) thyroiditis: a randomized controlled clinical trial.

Context: Hashimoto's thyroiditis is less prevalent in tobacco smokers. Anatabine, an alkaloid found in Solanaceae plants including tobacco, has been reported to ameliorate a mouse model of Hashimoto's thyroiditis.

Objective: The effects of anatabine in patients with Hashimoto's thyroiditis were studied.

Islet-specific T-cell responses and proinflammatory monocytes define subtypes of autoantibody-negative ketosis-prone diabetes.

Objective: Ketosis-prone diabetes (KPD) is characterized by diabetic ketoacidosis (DKA) in patients lacking typical features of type 1 diabetes. A validated classification scheme for KPD includes two autoantibody-negative ("A-") phenotypic forms: "A-β-" (lean, early onset, lacking β-cell functional reserve) and "A-β+" (obese, late onset, with substantial β-cell functional reserve after the index episode of DKA). Recent longitudinal analysis of a large KPD cohort revealed that the A-β+ phenotype includes two distinct subtypes distinguished by the index DKA episode having a defined precipitant ("provoked," with progressive β-cell function loss over time) or no precipitant ("unprovoked," with sustained β-cell functional reserve).

Characteristics of patients with ketosis-prone diabetes (KPD) presenting with acute pancreatitis: implications for the natural history and etiology of a KPD subgroup.

Objective: Reports of concomitant diabetic ketoacidosis (DKA) and acute pancreatitis (AP) are lacking among emerging forms of diabetes. This longitudinal study characterized ketosis-prone diabetes (KPD) in patients presenting with concomitant AP and DKA.

Methods: Multi-ethnic KPD patients (N = 755) were followed prospectively for 1 year from the time of index DKA using repeated metabolic and beta cell functional reserve measures.

Pathogenesis of A⁻β⁺ ketosis-prone diabetes.

A⁻β⁺ ketosis-prone diabetes (KPD) is an emerging syndrome of obesity, unprovoked ketoacidosis, reversible β-cell dysfunction, and near-normoglycemic remission. We combined metabolomics with targeted kinetic measurements to investigate its pathophysiology. Fasting plasma fatty acids, acylcarnitines, and amino acids were quantified in 20 KPD patients compared with 19 nondiabetic control subjects.

Presence or absence of a known diabetic ketoacidosis precipitant defines distinct syndromes of "A-β+" ketosis-prone diabetes based on long-term β-cell function, human leukocyte antigen class II alleles, and sex predilection.

Ketosis-prone diabetes (KPD) is heterogeneous. Longitudinal follow-up revealed that patients with "A-β+" KPD (absent autoantibodies and preserved β-cell function) segregated into 2 subgroups with distinct evolution of β-cell function and glycemic control. Generalized linear analysis demonstrated that the variable that most significantly differentiated them was presence of a clinically evident precipitating event for the index diabetic ketoacidosis (DKA).

Gene therapy with neurogenin 3 and betacellulin reverses major metabolic problems in insulin-deficient diabetic mice.

Insulin deficiency in type 1 diabetes leads to disruptions in glucose, lipid, and ketone metabolism with resultant hyperglycemia, hyperlipidemia, and ketonemia. Exogenous insulin and hepatic insulin gene therapy cannot mimic the robust glucose-stimulated insulin secretion (GSIS) from native pancreatic islets. Gene therapy of streptozotocin-diabetic mice with neurogenin 3 (Ngn3) and betacellulin (Btc) leads to the induction of periportal oval cell-derived neo-islets that exhibit GSIS.

Optical coherence tomography and its use in detection of vulnerable plaque.

Acute coronary syndromes and their associated complications related to coronary ischemia continue to be the leading cause of morbidity and mortality in the world. The most commonly encountered pathophysiologic cascade of events resulting in this picture is initiated by formation of a vulnerable plaque. Despite the widespread use of a variety of imaging technologies, high-resolution detection of the vulnerable plaque and designing a method to correlate the results of the imaging modality with disease severity and prognosis have proven to be an arduous task.

Vulnerable plaque: definition, detection, treatment, and future implications.

Atherosclerosis continues to account for significant morbidity and mortality in most of the world. The major proportion of atherosclerosis mortality is related to atherosclerotic coronary artery disease, yet there still is not an optimal method for making the diagnosis of vulnerable plaque in vivo. The search for such an undefined method, along with studies on amelioration of currently available technology, gains special significance when the association between the qualitative definition of lesions in an individual and cardiovascular risks are considered.

The lectin-like oxidized low-density lipoprotein receptor and its role in atherosclerosis.

The lectin-like oxidized low-density lipoprotein receptor (LOX-1), a recently identified receptor that plays a role in the uptake of oxidized low-density lipoproteins into endothelial cells, has a pivotal role in the pathogenesis of atherosclerosis. The ways this receptor takes part in atherosclerosis is through uptake of oxidized low-density lipoproteins into endothelial cells, smooth muscle cells, and macrophages; decreasing nitric oxide production; increasing inflammatory cell recruitment; and increasing smooth muscle cell proliferation. LOX-1 is inducible and regulated by multiple factors known to underlie atherogenesis.