Traditional postero-medial ankle approach for Bartonícek type III in Volkmann Fractures: Is it useful?

Introduction: There is evidence that the presence of a posterior malleolus fracture (PMF) worsens the prognosis of ankle fractures, making conservative treatment a poor choice. PMFs include a heterogeneous group of bone injury patterns that are sometimes associated to medial malleolus extensions, as well as fibula fractures or syndesmotic damage. This requires the surgeon to be well-versed in anatomy to choose the appropriate surgical approach.

Anatomical analysis of the traditional postero-medial approach to the ankle and evaluation of structures at risk.

Introduction: The presence of a fracture of the posterior malleolus gives a poor prognosis for ankle fractures. This study aimed to analyze the anatomical structures at risk in the traditional postero-medial (TPM) approach.

Methods: Of a total of 21 cadaveric pieces, 11 were female and 10 were male; 9 ankles/right foot and 11 ankles/left foot.

Ketamine-assisted buprenorphine initiation: a pilot case series.

Background: Many people with opioid use disorder who stand to benefit from buprenorphine treatment are unwilling to initiate it due to experience with or fear of both spontaneous and buprenorphine-precipitated opioid withdrawal (BPOW). An effective means of minimizing withdrawal symptoms would reduce patient apprehensiveness, lowering the barrier to buprenorphine initiation. Ketamine, approved by the FDA as a dissociative anesthetic, completely resolved BPOW in case reports when infused at a sub-anesthetic dose range in which dissociative symptoms are common.

AIR SAC TREMATODES (CYCLOCOELIDAE STOSSICH, 1902) INFECTING BIRDS IN ZOOLOGICAL INSTITUTIONS IN THE UNITED STATES.

Air sac trematodes (Digenea: Cyclocoelidae) were detected in 23 avian species from eight aviaries in the United States. Most of the infected host species were passeriform birds, but a few species in other orders also were infected. Four species of adult flukes were encountered: , sp.

Coming full circle: The potential utility of real-world evidence to discern predictions from a physiologically based pharmacokinetic model.

Today real word data (RWD) are playing a greater role in informing health care decisions. A physiologically based pharmacokinetic model (PBPK) and observed exposure-risk relationship predicted an increased bleeding risk induced by rivaroxaban (RXB) in patients with mild to moderate chronic kidney disease (CKD) taking concomitant medications that are combined Pgp-CYP3A inhibitors. In this commentary, we explore the potential use of RWD to assess the clinical consequence of this complex drug-drug interaction predicted from PBPK.

Synthetic microfiber emissions from denim industrial washing processes: An overlooked microplastic source within the manufacturing process of blue jeans.

In recent years, domestic laundry has been recognized as a relevant source of microfiber (MF) pollution to aquatic environments. Nevertheless, the MF emissions from industrial washing processes in real world scenarios have not been quantified. The aim of this study was to quantify the MF emissions from 3 industrial washing processes (rinse wash, acid wash and enzymatic wash) commonly employed in the manufacturing process of blue jeans.

A hybrid open-arthroscopic latarjet coracoid bone-block technique using "HyLa" instrumentation.

Latarjet coracoid bone-block is a gold-standard procedure for anteroinferior instability of the shoulder. Nowadays, it can be performed as open surgery or entirely under arthroscopy. The pure arthroscopic technique has the advantage of allowing concomitant intra-articular surgery, but involves a long learning curve.

Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology.

Since 2016, results from physiologically based pharmacokinetic (PBPK) analyses have been routinely found in the clinical pharmacology section of regulatory applications submitted to the US Food and Drug Administration (FDA). In 2018, the Food and Drug Administration's Office of Clinical Pharmacology published a commentary summarizing the application of PBPK modeling in the submissions it received between 2008 and 2017 and its impact on prescribing information. In this commentary, we provide an update on the application of PBPK modeling in submissions received between 2018 and 2019 and highlight a few notable examples.

Long-term durability of a physician-modified endovascular graft.

We present a unique assessment confirming the long-term durability of a physician-modified endograft deployed as part of an Investigational Device Exemption clinical trial (NCT# 01538056). After receiving an intact postmortem aorta 7 years after the index procedure, we performed microcomputed tomography, necropsy, and metallurgical analysis on the specimen. Microcomputed tomography showed a single strut fracture not noted during previous surveillance.

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration's Office of Clinical Pharmacology.

This commentary provides an update on the status of physiologically based pharmacokinetic modeling and simulation at the U.S. Food and Drug Administration's Office of Clinical Pharmacology.

Canal Transportation, Unprepared Areas, and Dentin Removal after Preparation with BT-RaCe and ProTaper Next Systems.

Introduction: This study compared the shaping ability of ProTaper Next (Dentsply Sirona, Tulsa, OK) and BT-RaCe (FKG Dentaire, La Chaux-de-Fonds, Switzerland) instrument systems in the mesial canals of mandibular molars using micro-computed tomographic (micro-CT) imaging.

Methods: A total of 17 type IV mesial roots of extracted first mandibular molars were scanned using micro-CT imaging before and after root canal preparation with the 2 instrument systems. Both systems were used in the same root but alternating the mesial canals from root to root.

Perspectives in regulatory science: translational and clinical pharmacology.

This paper focuses on the role of clinical and translational pharmacology in the drug development and the regulatory process. Contemporary regulatory issues faced by FDA's Office of Clinical Pharmacology (OCP) in fulfilling its mission to advance the science of drug response and translate patient diversity into optimal drug therapy are discussed. Specifically current focus of the following key aspects of the drug development and regulatory science processes are discussed: the OCP vision and mission, two key OCP initiatives (i.

The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives.

Transporters play an important role in drug absorption, disposition, and drug action. The evaluation of drug transporters requires a comprehensive understanding of transporter biology and pharmacology. Physiologically based pharmacokinetic (PBPK) models may offer an integrative platform to quantitatively evaluate the role of drug transporters and its interplay with other drug disposition processes such as passive drug diffusion and elimination by metabolizing enzymes.

Popliteal artery thrombosis complicating posterior tibial exostosis in a 35-year-old male.

Chronic popliteal artery thrombosis complicating tibial exostosis has never been described as far as we know. Here, we report the case of a 35-year-old male patient complaining of intermittent claudication over the previous 4 months, without history of trauma or hereditary multiple exostoses. Clinical examination found no popliteal or distal pulses.

Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels.

Genetic basis of familial dilated cardiomyopathy patients undergoing heart transplantation.

Background: Dilated cardiomyopathy (DCM) is the most frequent cause of heart transplantation (HTx). The genetic basis of DCM among patients undergoing HTx has been poorly characterized. We sought to determine the genetic basis of familial DCM HTx and to establish the yield of modern next generation sequencing (NGS) technologies in this setting.

[Association between sperm abnormalities and occupational environment among male consulting for couple infertility].

Alteration of sperm parameters related to occupational exposures is the subject of several studies, often on a case-control approach. The study populations usually comprise men consulting in infertility clinics for couple infertility. The objective of this review is to identify, from these case-control studies, the main occupational factors that may be associated with altered sperm parameters.

Time-dependent effects of CX3CR1 in a mouse model of mild traumatic brain injury.

Background: Neuroinflammation is an important secondary mechanism that is a key mediator of the long-term consequences of neuronal injury that occur in traumatic brain injury (TBI). Microglia are highly plastic cells with dual roles in neuronal injury and recovery. Recent studies suggest that the chemokine fractalkine (CX3CL1, FKN) mediates neural/microglial interactions via its sole receptor CX3CR1.

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK.

The US Food and Drug Administration (FDA) public workshop, entitled "Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection focused on the role of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary and panel discussions. This report summarizes the discussions and provides current perspectives on the application of PBPK in different areas, including its utility, predictive performance, and reporting for regulatory submissions.