What's in a word? Defining "gene therapy medicines".

Gene therapy medicinal products (GTMPs) have emerged as a transformative class of medicines. Defining what a certain class of medicines encompasses, and what it does not, is key, with ample implications and consequential regulatory requirements. In April 2023, the European Commission proposed new pharmaceutical legislation safeguarding the public health within the European Union with a new, broader definition of GTMP, including genome editing medicines and nucleic acids of either source, regulating, replacing, or adding a genetic sequence that mediates its effect by transcription or translation.

Content validation of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (NFLymSI-18) in indolent B-cell non-Hodgkin's lymphoma.

Background: The NFLymSI-18 is a patient-reported outcome measure comprised of the highest priority symptoms, emotional concerns, treatment side effects, and other concerns identified by lymphoma patients and oncologists. This study assessed the content validity of the NFLymSI-18 for patients with indolent B-cell non-Hodgkin's lymphoma (iNHL), with a focus on the Disease-Related Symptoms Physical (DRS-P) subscale.

Methods: Patients with a confirmed iNHL diagnosis who had received one or more lines of treatment were recruited during clinic visits.

The association between sensory processing and stress in the adult population: A systematic review.

There is emerging empirical evidence indicating that differences in self-reported sensory processing may be associated with differences in levels of stress in the adult populations. Understanding how sensory processing relates to stress is of clinical relevance, given the well-established impact of stress on physical health, mental health and well-being. Although several studies have examined the association between sensory processing and stress in adult populations, no published reviews have systematically summarised and synthesised these findings.

The impact of low pressure pneumoperitoneum in robotic assisted radical prostatectomy II: a prospective, randomized, double blinded trial.

Objective: To analyze postoperative ileus rates and postoperative complications between the different pneumoperitoneum settings. The secondary objective was to evaluate narcotic use and intraoperative blood loss between the different pneumoperitoneum settings.

Methods: A prospective, randomized, double blinded study was conducted at pneumoperitoneum pressures of either 12 mmHg or 15 mmHg for patients undergoing robotic assisted radical prostatectomy with bilateral pelvic lymph node dissection by a single high volume surgeon.

Ensemble Detection of DNA Engineering Signatures.

Synthetic biology is creating genetically engineered organisms at an increasing rate for many potentially valuable applications, but this potential comes with the risk of misuse or accidental release. To begin to address this issue, we have developed a system called GUARDIAN that can automatically detect signatures of engineering in DNA sequencing data, and we have conducted a blinded test of this system using a curated Test and Evaluation (T&E) data set. GUARDIAN uses an ensemble approach based on the guiding principle that no single approach is likely to be able to detect engineering with perfect accuracy.

Implementation of type 1 diabetes genetic risk screening in children in diverse communities: the Virginia PrIMeD project.

Background: Population screening for risk of type 1 diabetes (T1D) has been proposed to identify those with islet autoimmunity (presence of islet autoantibodies). As islet autoantibodies can be transient, screening with a genetic risk score has been proposed as an entry into autoantibody testing.

Methods: Children were recruited from eight general pediatric and specialty clinics across Virginia with diverse community settings.

Geophysical signatures of soil AFFF contamination from spectral induced polarization and low field nuclear magnetic resonance methods.

Few field methods are available for characterizing source zones impacted with aqueous film forming foam (AFFF). Non-invasive geophysical characterization of AFFF source zone contamination in situ could assist with the delineation and characterization of these sites, allowing for more informed sampling regimes aimed at quantifying subsurface poly- and perfluoroalkyl substances (PFAS) contamination. We present initial results from the investigation of the sensitivity of two existing surface and borehole-deployable geophysical technologies, spectral induced polarization (SIP), and low field nuclear magnetic resonance (NMR), to soils impacted with AFFF.

Systematic Part Transfer by Extending a Modular Toolkit to Diverse Bacteria.

It is impractical to develop a new parts collection for every potential host organism. It is well-established that gene expression parts, like genes, are qualitatively transferable, but there is little quantitative information defining transferability. Here, we systematically quantified the behavior of a parts set across multiple hosts.

Adolescent male with bilateral succinate dehydrogenase-deficient renal cell carcinoma in a horseshoe kidney managed successfully with staged bilateral robotic-assisted partial nephrectomies: A case report.

Succinate dehydrogenase (SDH) deficient renal cell carcinoma (RCC) is a rare subset of familial RCC with only 59 cases reported. SDH deficiency is associated with hereditary paraganglioma/pheochromocytoma syndrome. Most of the cases are solitary tumors with only two reported cases of bilateral tumor.

Automated optimization of spatial resolution for single-sided NMR.

Single-sided NMR instruments utilize inhomogeneous magnetic fields with strong gradients to nondestructively probe physical properties of materials. The sensitive region of this type of magnet is often a thin slice above the magnet's surface; measuring planar samples with high spatial resolution requires coplanarity between the sensitive region of the magnet and the sample region of interest. We developed an algorithmic approach to position flat samples coplanar with the magnet's sensitive region.

Deepwater Horizon Oil Spill Exposures and Long-term Self-rated Health Effects Among Parents in Coastal Louisiana.

Purpose: To assess whether exposure to the 2010 Deepwater Horizon oil spill (DHOS) was related to parents' self-rated health over time.

Design: 3 waves of panel data were drawn from the Gulf Coast Population Impact study (2014) and Resilient Children, Youth, and Communities study (2016, 2018).

Setting: Coastal Louisiana communities in high-impact DHOS areas.

Prognosis and oncogenomic profiling of patients with tropomyosin receptor kinase fusion cancer in the 100,000 genomes project.

Introduction: Neurotrophic tyrosine receptor kinase (NTRK) gene fusions are oncogenic drivers in various tumor types. Limited data exist on the overall survival (OS) of patients with tumors with NTRK gene fusions and on the co-occurrence of NTRK fusions with other oncogenic drivers.

Materials And Methods: This retrospective study included patients enrolled in the Genomics England 100,000 Genomes Project who had linked clinical data from UK databases.

Discovering Content through Text Mining for a Synthetic Biology Knowledge System.

Scientific articles contain a wealth of information about experimental methods and results describing biological designs. Due to its unstructured nature and multiple sources of ambiguity and variability, extracting this information from text is a difficult task. In this paper, we describe the development of the synthetic biology knowledge system (SBKS) text processing pipeline.

Parental Education and Child Physical Health Following the BP Deepwater Horizon Oil Spill.

Purpose: To assess whether trajectories of children's physical health problems differ by parental college degree attainment in Louisiana areas highly impacted by the 2010 BP Deepwater Horizon oil spill (BP-DHOS).

Design: Three waves of panel data (2014, 2016, and 2018) from the Gulf Coast Population Impact / Resilient Children, Youth, and Communities studies.

Setting: BP-DHOS-impacted communities in coastal Louisiana.

Indirect Treatment Comparison of Larotrectinib versus Entrectinib in Treating Patients with TRK Gene Fusion Cancers.

Information regarding the comparative efficacy of first-generation receptor tyrosine kinase inhibitors is limited. This matching-adjusted indirect comparison (MAIC) evaluated differences in efficacy and safety across larotrectinib and entrectinib trials. Data from clinical trials for larotrectinib (LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431)) and entrectinib (ALKA-372-001 (EudraCT 2012-000148-88), STARTRK-1 (NCT02097810), and STARTRK-2 (NCT02568267)) were used.

Possible Contributions of Nongenomic Actions of Thyroid Hormones to the Vasculopathic Complex of COVID-19 Infection.

Background: Integrin αvβ3 is a cell membrane structural protein whose extracellular domain contains a receptor for L-thyroxine (T4). The integrin is expressed in rapidly dividing cells and its internalization is prompted by T4. The protein binds viruses and we have raised the possibility elsewhere that action of free T4 (FT4)-when he latter is increased in the nonthyroidal illness syndrome (NTIS) known to complicate COVID-19 infecction-may enhance cellular uptke of SARS-CoV-2 and its receptor.

Robotic-assisted nephrectomy with level II IVC thrombectomy using Rummel Tourniquets.

Background:: Inferior vena cava (IVC) invasion from renal cell carcinoma (RCC) occurs at a rate of 4-10% (1). IVC thrombectomy (IVC-TE) can be an open procedure because of the need for handling of the IVC (2). The first reported series of robotic management of IVC-TE started in 2011 for the management of Level I - II thrombi with subsequent case reports in recent years (2-5).

Curation Principles Derived from the Analysis of the SBOL iGEM Data Set.

As an engineering endeavor, synthetic biology requires effective sharing of genetic design information that can be reused in the construction of new designs. While there are a number of large community repositories of design information, curation of this information has been limited. This in turn limits the ways in which design information can be put to use.

Synthetic Biology Knowledge System.

The Synthetic Biology Knowledge System (SBKS) is an instance of the SynBioHub repository that includes text and data information that has been mined from papers published in ACS Synthetic Biology. This paper describes the SBKS curation framework that is being developed to construct the knowledge stored in this repository. The text mining pipeline performs automatic annotation of the articles using natural language processing techniques to identify salient content such as key terms, relationships between terms, and main topics.

Actions of Thyroid Hormones on Thyroid Cancers.

L-Thyroxine (T4) is the principal ligand of the thyroid hormone analogue receptor on the extracellular domain of integrin αvβ3. The integrin is overexpressed and activated in cancer cells, rapidly dividing endothelial cells, and platelets. The biologic result is that T4 at physiological concentration and without conversion to 3,3',5-triiodo-L-thyronine (T3) may stimulate cancer cell proliferation and cancer-relevant angiogenesis and platelet coagulation.

Education Crisis, Workforce Preparedness, and COVID-19: Reflections and Recommendations.

This article explores the impact of COVID-19 on the higher education crisis and its implications for workforce preparedness and the future of work. It takes an integrative look at the evolving role of three primary actors involved in higher education: traditional universities, corporate universities, and educational technology companies, before, during, and after the pandemic. We conclude with recommendations for reframing discussions about higher education and workforce preparation to achieve a better balance between the workforce needs of the corporate world and those of society.

Are Postoperative Laboratory Studies Following Robotic Assisted Radical Prostatectomy Necessary?

Introduction: We evaluated the necessity of obtaining routine postoperative laboratory studies, such as complete blood count and basic metabolic panel, after robotic assisted radical prostatectomy.

Methods: This study is a retrospective review of 200 robotic assisted radical prostatectomy cases performed over a year and a half at our institution. The incidences of laboratory abnormalities were examined along with any clinical intervention.

How we do it: robotic-assisted distal ureterectomy with ureteral reimplantation.

Background:: High risk upper tract urothelial carcinoma (UTUC) is typically managed with radical nephroureterectomy, however, renal preservation can be attempted when UTUC is localized to the distal ureter in the presence of chronic kidney disease (–3). Distal ureterectomy is typically managed with a ureteral reimplantation and psoas hitch in order to maintain urothelial continuity, to avoid comprising the contralateral ureter, and reducing risk of chronic urinary tract infections and electrolyte abnormalities (4). We present our case of distal ureteral UTUC managed robotically with a distal ureterectomy with ureteral reimplantation.