Regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis.

Background: Type 1 diabetes is a serious, chronic disorder with an increasing incidence among children and adolescents. Glycemic control in individuals with type 1 diabetes is better managed through a basal-bolus regimen with either regular human or rapid-acting insulin analogues administered as a bolus at mealtimes. Rapid-acting insulin analogues have been hypothesized to cause optimal glycemic control and less risk of hypoglycemic episodes compared to regular human insulins.

Missing outcome data in randomised clinical trials of psychological interventions: a review of published trial reports in major psychiatry journals.

Background: Missing outcome data can pose a serious threat to the validity of randomised clinical trial results. We aimed to study the extent of missing outcome data in randomised clinical trials of psychological interventions.

Methods: We performed a retrospective study of randomised clinical trial reports of psychological interventions published in World Psychiatry, JAMA Psychiatry, Lancet Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry, or Psychotherapy and Psychosomatics from 2017 to 2022.

The risks of adverse events with venlafaxine for adults with major depressive disorder: a systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis.

Aims: Venlafaxine is used to treat depression worldwide. Previous reviews have demonstrated that venlafaxine lowers scores on depression rating scales, producing statistically significant results but the relevance to patients remains uncertain. Knowledge of the incidence of the adverse effects associated with venlafaxine has previously been based on the results of non-randomised studies.

Beneficial and harmful effects of tricyclic antidepressants for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis.

Question: Tricyclic antidepressants are used to treat depression worldwide, but the adverse effects have not been systematically assessed. Our objective was to assess the beneficial and harmful effects of all tricyclic antidepressants for adults with major depressive disorder.

Study Selection And Analysis: We conducted a systematic review with meta-analysis and trial sequential analysis.

Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement.

Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required.

Continuous Levodopa Delivery with an Intraoral Micropump System: An Open-Label Pharmacokinetics and Clinical Study.

Background: Double-blind studies have demonstrated that motor complications in Parkinson's disease (PD) can be reduced with continuous delivery of levodopa. The DopaFuse system is a novel, intraoral micropump that attaches to a retainer and uses a propellant to deliver levodopa/carbidopa (LD/CD) continuously into the mouth.

Objectives: Evaluate the safety, pharmacokinetics, and efficacy of LD/CD delivered via the DopaFuse system compared to treatment with intermittent doses of standard oral LD/CD in PD patients with motor fluctuations.

Transdermal Nicotine Treatment and Progression of Early Parkinson's Disease.

BACKGROUND: Epidemiologic studies show that smokers have a lower incidence of Parkinson’s disease. Nicotine has been hypothesized to slow progression in early Parkinson’s disease. METHODS: In a double-blind, placebo-controlled multicenter trial, we randomly assigned patients with Parkinson’s disease, diagnosed within 18 months, who were in Hoehn and Yahr disease stage less than or equal to 2 (range from 0 to 5; higher scores indicate greater impairment), who were therapy naïve (except for stable monoamine-oxidase-B inhibition), and not requiring dopaminergic therapy, to transdermal nicotine or placebo.

Diagnostic accuracy of the Dutch version of the Somatic Symptom Disorder - B Criteria Scale (SSD-12) compared to the Whiteley Index (WI) and PHQ-15 in a clinical population.

Objective: Somatic Symptom and Related Disorders(SSRD) are characterised by an intense focus on somatic symptoms that causes significant distress. A self-report scale developed to assess distress as symptom-related thoughts, feelings, and behaviors (SSD-12) has proved to be a reliable, valid and time-efficient measure for Somatic Symptom Disorder(SSD). This cross-sectional study aimed to compare the SSD-12 with psychiatric assessment as gold standard in a Dutch clinical population for SSRD compared to other widely used measures.

Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement.

Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care.

Do five screening tools identify the same number of runners who require pre-exercise medical clearance? SAFER XXXIV.

Objectives: Currently, there are five international screening tools that are recommended to identify individuals who require pre-exercise medical clearance to reduce the risk of medical encounters during exercise. Therefore, the aim was to determine the percentage of race entrants who are advised to obtain pre-exercise medical clearance and the observed agreement between these five different international pre-exercise medical screening tools.

Methods: In all, 76,654 race entrants from the Two Oceans Marathon (2012-2015) that completed an online pre-race screening questionnaire.

Is Intermittent Control the Source of the Non-Linear Oscillatory Component (0.2-2Hz) in Human Balance Control?

Objective: To explain the 0.2-2Hz oscillation in human balance.

Motivation: Oscillation (0.

Augmented Reality in Radiology for Education and Training-A Design Study.

Education is an important component of every healthcare system. Patients need to be educated about their planned procedures; healthcare professionals need to be trained in their respective profession. Both patient education and the training of healthcare professionals are often completed in person, which requires resources and is bound to certain times and places.

Tailoring Codon Usage to the Underlying Biology for Protein Expression Optimization.

For heterologous gene expression, codon optimization is required to enhance the quality and quantity of the protein product. Recently, we introduced the software tool OCTOPOS. This sequence optimizer combines a detailed mechanistic mathematical modeling of in vivo protein synthesis with a state-of-the-art machine learning algorithm to find the sequence that best serves a user's needs.

Distinct single-component adjuvants steer human DC-mediated T-cell polarization via Toll-like receptor signaling toward a potent antiviral immune response.

The COVID-19 pandemic highlights the importance of efficient and safe vaccine development. Vaccine adjuvants are essential to boost and tailor the immune response to the corresponding pathogen. To allow for an educated selection, we assessed the effect of different adjuvants on human monocyte-derived dendritic cells (DCs) and their ability to polarize innate and adaptive immune responses.

How to draw the line - Raman spectroscopy as a tool for the assessment of biomedicines.

Biomedicines are complex biochemical formulations with multiple components that require extensive quality control during manufacturing and in subsequent batch testing. A proof-of-concept study has shown that an application of Raman spectroscopy can be beneficial for a classification of vaccines. However, the complexity of biomedicines introduces new challenges to spectroscopic methodology that require advanced experimental protocols.

Evaluation of the in vitro Function of Platelet Concentrates from Pooled Buffy Coats or Apheresis.

Background: Platelet concentrates play an important role in transfusion medicine. Their short lifespan and lack of robustness require efforts to ensure adequate product quality. In this study, we compared the in vitro quality of the main concentrate types, pooled platelet concentrate (PPC) from whole blood donations, and platelet concentrate from single-donor apheresis (APC).

Kinetic Fingerprinting Links Bacteria-Phage Interactions with Emergent Dynamics: Rapid Depletion of Indicates Phage Synergy.

The specific temporal evolution of bacterial and phage population sizes, in particular bacterial depletion and the emergence of a resistant bacterial population, can be seen as a that depends on the manifold interactions of the specific phage-host pair during the course of infection. We have elaborated such a kinetic fingerprint for a human urinary tract isolate and its phage vB_KpnP_Lessing by a modeling approach based on data from co-culture. We found a faster depletion of the initially sensitive bacterial population than expected from simple mass action kinetics.

Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations.

Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, the purpose of which was to recommend approaches that facilitate interpretation of analgesic RCTs. We review issues to consider when drawing conclusions from RCTs, as well as common methods for reporting RCT results and the limitations of each method.