Defining textbook outcome for selective internal radiation therapy of hepatocellular carcinoma: an international expert study.

BACKGROUND: A textbook outcome (TO) is a composite indicator covering the entire intervention process in order to reflect the "ideal" intervention and be a surrogate for patient important outcomes. Selective internal radiation therapy (SIRT) is a complex multidisciplinary and multistep intervention facing the challenge of standardization. This expert opinion-based study aimed to define a TO for SIRT of hepatocellular carcinoma. METHODS: This study involved two steps: (1) the steering committee (4 interventional radiologists) first developed an extensive list of possible relevant items reflecting an optimal SIRT intervention based on a literature review and (2) then conducted an international and multidisciplinary survey which resulted in the final TO. This survey was online, from February to July 2021, and consisted three consecutive rounds with predefined settings. Experts were identified by contacting senior authors of randomized trials, large observational studies, or studies on quality improvement in SIRT. This study was strictly academic. RESULTS: A total of 50 items were included in the first round of the survey. A total of 29/40 experts (73%) responded, including 23 interventional radiologists (79%), three nuclear medicine physicians (10%), two hepatologists, and one oncologist, from 11 countries spanning three continents. The final TO consisted 11 parameters across six domains ("pre-intervention workup," "tumor targeting and dosimetry," "intervention," "post-90Y imaging," "length of hospital stay," and "complications"). Of these, all but one were applied in the institutions of > 80% of experts. CONCLUSIONS: This multidimensional indicator is a comprehensive standardization tool, suitable for routine care, clinical round, and research.

From Synthesis to Microstructure: Engineering the High-entropy Ceramic Materials of the Future.

Sintering and microstructural development in ceramics has long been studied in a two-dimensional grain size-density space, with only texture (i.e. deviation of grain orientation from random) used to gain first insights into additional parametric spaces. Following an increased interest for grain boundary engineering and a deeper understanding of dopant effects on sintering and grain boundaries, the theory of complexion transitions for ceramics has been introduced over the last decade, providing a new base for advanced microstructure engineering in ceramics. With emergence of high entropy ceramics over the last 5 years, the combination of both yields new grounds for exploration and engineering of functional ceramic materials of the future.

Yttrium-90 Radioembolization in Intrahepatic Cholangiocarcinoma: A Multicenter Retrospective Analysis.

PURPOSE: To report outcomes of yttrium-90 (90Y) radioembolization in patients with unresectable intrahepatic cholangiocarcinoma (ICC). MATERIALS AND METHODS: Retrospective review was performed of 115 patients at 6 tertiary care centers; 92 were treated with resin microspheres (80%), 22 were treated with glass microspheres (19%), and 1 was treated with both. Postintervention outcomes were compared between groups with χ2 tests. Survival after diagnosis and after treatment was assessed by Kaplan-Meier method. RESULTS: Grade 3 laboratory toxicity was observed in 4 patients (4%); no difference in toxicity profile between resin and glass microspheres was observed (P = .350). Clinical toxicity per Society of Interventional Radiology criteria was noted in 29 patients (25%). Partial response per Response Evaluation Criteria In Solid Tumors 1.1 was noted in 25% of patients who underwent embolization with glass microspheres and 3% of patients who were treated with resin microspheres (P = .008). Median overall survival (OS) from first diagnosis was 29 months (95% confidence interval [CI], 21-37 mo) for all patients, and 1-, 3-, and 5-year OS rates were 85%, 31%, and 8%, respectively. Median OS after treatment was 11 months (95% CI, 8-13 mo), and 1- and 3-year OS rates were 44% and 4%, respectively. These estimates were not significantly different between resin and glass microspheres (P = .730 and P = .475, respectively). Five patients were able to undergo curative-intent resection after 90Y radioembolization (4%). CONCLUSIONS: This study provides observational data of treatment outcomes after 90Y radioembolization in patients with unresectable ICC.

Clinical and dosimetric considerations for Y90: recommendations from an international multidisciplinary working group.

The TheraSphere Global Dosimetry Steering Committee was formed in 2017 by BTG International to review existing data and address gaps in knowledge related to dosimetry. This committee is comprised of health care providers with diverse areas of expertise and perspectives on radiation dosimetry. The goal of these recommendations is to optimize glass microspheres radiation therapy for hepatocellular carcinoma while accounting for variables including disease presentation, tumour vascularity, liver function, and curative/palliative intent. The recommendations aim to unify glass microsphere users behind standardized dosimetry methodology that is simple, reproducible and supported by clinical data, with the overarching goal of improving clinical outcomes and advancing the knowledge of dosimetry.

Yttrium-90 Transarterial Radioembolization for Chemotherapy-Refractory Intrahepatic Cholangiocarcinoma: A Prospective, Observational Study.

PURPOSE: To evaluate the safety and efficacy of yttrium-90 transarterial radioembolization (TARE) for the treatment of unresectable, chemotherapy-refractory intrahepatic cholangiocarcinoma (ICC). METHODS: A prospective, observational study was carried out in 10 centers between 2013 and 2017. TARE plus standard care was delivered to patients with unresectable, chemotherapy-refractory or chemotherapy-intolerant ICC. Primary outcome was overall survival. Secondary outcomes included safety, progression-free survival (PFS), and liver-specific progression-free survival (LPFS). RESULTS: Sixty-one patients were treated with TARE. Patients were 53% male; median age was 64 years; 91% had performance status 0/1; 92% had received prior chemotherapy; and 59% had no extrahepatic disease. Median follow-up was 13.9 months (95% confidence interval [CI], 9.6-18.1). Overall survival was 8.7 months (95% CI, 5.3-12.1), and 37% of patients survived to 12 months. PFS was 2.8 months (95% CI, 2.6-3.1), and LPFS was 3.1 months (95% CI, 1.3-4.8). One severe complication (abdominal pain) occurred at the time of the TARE procedure. Thirty patients experienced a total of 49 adverse events, of which 8% were grade ≥3; most common were grade 1-2 fatigue and abdominal pain. A total of 77 abnormal laboratory value events were recorded, of which 4% were grade ≥3. CONCLUSIONS: Patients with advanced ICC have limited therapeutic options and a poor prognosis. This prospective study examined the survival of patients with unresectable, chemotherapy-refractory primary ICC treated with TARE in real-world practice. The results demonstrate that this treatment merits further investigation in this patient cohort in a larger study, including collection of patient-reported outcomes.

Update on Treatment Options for Advanced Bile Duct Tumours: Radioembolisation for Advanced Cholangiocarcinoma.

Cholangiocarcinoma is a rare form of gastrointestinal cancer with a poor prognosis. Patients often present with biliary obstruction or non-specific abdominal pain, and a high proportion of patients have advanced disease at initial diagnosis. The goal of this review is to discuss treatment options for patients with advanced bile duct tumours focusing on radioembolisation (RE) and its impact on overall survival. RE provides a therapeutic option for patients with unresectable cholangiocarcinoma. However, although systemic chemotherapy has demonstrated a survival benefit in randomised controlled trials, there is limited supporting evidence for the use of RE in this setting. Studies are mostly limited to single-centre, small cohorts with variable outcome measures. Additionally, patients included in these studies received a variety of previous therapies including chemotherapy, surgery or alternative intra-arterial therapy; therefore, a true assessment of overall survival benefit is difficult.

Carbohydrate-mediated purification of petrochemicals.

Metal-organic frameworks (MOFs) are known to facilitate energy-efficient separations of important industrial chemical feedstocks. Here, we report how a class of green MOFs-namely CD-MOFs-exhibits high shape selectivity toward aromatic hydrocarbons. CD-MOFs, which consist of an extended porous network of γ-cyclodextrins (γ-CDs) and alkali metal cations, can separate a wide range of benzenoid compounds as a result of their relative orientation and packing within the transverse channels formed from linking (γ-CD)6 body-centered cuboids in three dimensions. Adsorption isotherms and liquid-phase chromatographic measurements indicate a retention order of ortho- > meta- > para-xylene. The persistence of this regioselectivity is also observed during the liquid-phase chromatography of the ethyltoluene and cymene regioisomers. In addition, molecular shape-sorting within CD-MOFs facilitates the separation of the industrially relevant BTEX (benzene, toluene, ethylbenzene, and xylene isomers) mixture. The high resolution and large separation factors exhibited by CD-MOFs for benzene and these alkylaromatics provide an efficient, reliable, and green alternative to current isolation protocols. Furthermore, the isolation of the regioisomers of (i) ethyltoluene and (ii) cymene, together with the purification of (iii) cumene from its major impurities (benzene, n-propylbenzene, and diisopropylbenzene) highlight the specificity of the shape selectivity exhibited by CD-MOFs. Grand canonical Monte Carlo simulations and single component static vapor adsorption isotherms and kinetics reveal the origin of the shape selectivity and provide insight into the capability of CD-MOFs to serve as versatile separation platforms derived from renewable sources.

Separation of rare gases and chiral molecules by selective binding in porous organic cages.

The separation of molecules with similar size and shape is an important technological challenge. For example, rare gases can pose either an economic opportunity or an environmental hazard and there is a need to separate these spherical molecules selectively at low concentrations in air. Likewise, chiral molecules are important building blocks for pharmaceuticals, but chiral enantiomers, by definition, have identical size and shape, and their separation can be challenging. Here we show that a porous organic cage molecule has unprecedented performance in the solid state for the separation of rare gases, such as krypton and xenon. The selectivity arises from a precise size match between the rare gas and the organic cage cavity, as predicted by molecular simulations. Breakthrough experiments demonstrate real practical potential for the separation of krypton, xenon and radon from air at concentrations of only a few parts per million. We also demonstrate selective binding of chiral organic molecules such as 1-phenylethanol, suggesting applications in enantioselective separation.

foxg1a is required for hair cell development and regeneration in the zebrafish lateral line.

Mechanosensory hair cells located in the inner ear mediate the sensations of hearing and balance. If damaged, mammalian inner ear hair cells are unable to regenerate, resulting in permanent sensory deficits. Aquatic vertebrates like zebrafish (Danio rerio) have a specialized class of mechanosensory hair cells found in the lateral line system, allowing them to sense changes in water current. Unlike mammalian inner ear hair cells, lateral line hair cells can robustly regenerate following damage. In mammals, the transcription factor Foxg1 functions to promote normal development of the inner ear. Foxg1a is expressed in lateral line sensory organs in zebrafish larvae, but its function during lateral line development and regeneration has not been investigated. Our study demonstrates that mutation of foxg1a results in slower posterior lateral line primordium migration and delayed neuromast formation. In developing and regenerating neuromasts, we find that loss of Foxg1a function results in reduced hair cell numbers, as well as decreased proliferation of neuromast cells. Foxg1a specifically regulates the development and regeneration of Islet1-labeled hair cells. These data suggest that Foxg1 may be a valuable target for investigation of clinical hair cell regeneration.

An Analysis of Food Recalls in the United States, 2002-2023.

This article evaluates and summarizes Food and Beverages (F&B) recalls managed or mandated by the U.S. Food and Drug Administration (FDA) over the past 20 years: the database includes over 35,000 recalls. For recall classification purposes, the causes were separated into 2 overall categories consisting of product contaminants or processing issues. The product contaminants category was further separated into 5 groups: allergens, biological contaminants, chemical contaminants, foreign objects, and undeclared food colors. The processing issues category was separated into 6 groups: cGMP issues, HACCP issues, manufacturing issues, mislabeling or misbranding, refrigeration issues, and under-processing. Product contaminants accounted for 91% of the F&B recalls, while processing issues accounted for the remaining 9%. Two groups accounted for about 76% of the recalls: biological contamination and allergens. The FDA classifies recalls by the potential severity of the health impact. Over half of the F&B recalls were Class I recalls, and biological contamination and allergens accounted for 96% of those recalls. Listeria monocytogenes was the largest cause of all of the recalls accounting for 7,844 recalls: 22% of the total recalls and 45% of the biological contamination recalls. Salmonella serovars were responsible for 6,597 recalls, including 18% of the total recalls and 38% of the biological recalls. Listeria and Salmonella serovars together resulted in 40% of all of the F&B recalls.

Kremen1 regulates the regenerative capacity of support cells and mechanosensory hair cells in the zebrafish lateral line.

Mechanosensory hair cells in the inner ear mediate the sensations of hearing and balance, and in the specialized lateral line sensory system of aquatic vertebrates, the sensation of water movement. In mammals, hair cells lack the ability to regenerate following damage, resulting in sensory deficits. In contrast, non-mammalian vertebrates, such as zebrafish, can renew hair cells throughout their lifespan. Wnt signaling is required for development of inner ear and lateral line hair cells and regulates regeneration. Kremen1 inhibits Wnt signaling and hair cell formation, though its role in regeneration is unknown. We used a zebrafish kremen1 mutant line to show overactive Wnt signaling results in supernumerary support cells and hair cell regeneration without increased proliferation, in contrast with the previously described role of Wnt signaling during hair cell regeneration. This work allows us to understand the biology of mechanosensory hair cells and how regeneration might be promoted following damage.

foxg1a is required for hair cell development and regeneration in the zebrafish lateral line.

Mechanosensory hair cells located in the inner ear mediate the sensations of hearing and balance. If damaged, mammalian inner ear hair cells are unable to regenerate, resulting in permanent sensory deficits. Aquatic vertebrates like zebrafish (Danio rerio) have a specialized class of mechanosensory hair cells found in the lateral line system, allowing them to sense changes in water current. Unlike mammalian inner ear hair cells, lateral line hair cells can robustly regenerate following damage. In mammalian models, the transcription factor Foxg1 functions to promote normal development of the inner ear. Foxg1a is expressed in lateral line sensory organs in zebrafish larvae, but its function during lateral line development and regeneration has not been investigated. We find that loss of Foxg1a function results in reduced hair cell development and regeneration, as well as decreased cellular proliferation in the lateral line system. These data suggest that Foxg1 may be a valuable target for investigation of clinical hair cell regeneration. Summary statement: Our work demonstrates a role for Foxg1a in developing and regenerating new sensory cells through proliferation.

Spectroelectrochemical study of carbon structural and functionality characteristics on vanadium redox reactions for flow batteries.

Vanadium redox flow batteries have applications for large-scale electricity storage. This paper reports the influence of carbon structural characteristics of sustainable walnut shell-derived carbons in carbon/polyvinylidene fluoride composite electrodes on vanadium redox reactions. Pyrolysis, gasification, and chemical treatment procedures were used to modify the structural characteristics of carbons. Carbon functional groups were modified by chemical treatment with HNO3, heat treatment with K2CO3, and high-temperature NH3 treatment. Carbon porous structures were characterized using gas adsorption studies. Raman spectroscopy and X-ray diffraction were used to characterize the carbon molecular structure. Functional groups were characterized using X-ray photoelectron spectroscopy, acid/base titrations, temperature-programmed desorption, and Fourier transform infrared spectroscopy. The influence of carbon structure, porosity, and surface functional groups on the redox reactions of vanadium was investigated using cyclic voltammetry and electrical impedance spectroscopy. The VO2+/VO2 + and V2+/V3+ couples had well-defined peaks in cyclic voltammetry, with the former being the most intense, but the V3+/VO2+ couple was not observed for samples carbonized under nitrogen. The results show that V2+/V3+ and VO2+/VO2 + couples observed in cyclic voltammograms were enhanced for carbonization temperatures up to 800 °C. Electrical impedance spectroscopy also showed impedance trends. The electrochemistry results are primarily related to changes in carbon structure and the catalysis of V3+ oxidation by surface functional groups in the carbon structure. The V3+/VO2+ couple was limited by slow kinetics, but it occurs on specific oxygen and nitrogen sites in the carbon structure. The oxidation of V(iii) to V(iv) only occurs on a limited number of surface sites, and the outer-sphere electron transfer to oxidize V(iii) takes place at much more positive potentials. The coulombic, voltage, and energy efficiency of the carbon electrodes were suitable for batteries.

Kremen1 regulates the regenerative capacity of support cells and mechanosensory hair cells in the zebrafish lateral line.

Mechanosensory hair cells in the inner ear mediate the sensations of hearing and balance, and in a specialize lateral line sensory system of aquatic vertebrates, the sensation of water movement. In mammals, hair cells lack the ability of regenerate following damage, resulting in sensory deficits. In contrast, non-mammalian vertebrates, such zebrafish, can renew hair cells throughout the life of the animal. Wnt signaling is required for development of inner ear and lateral line hair cells and regulates regeneration. Kremen1 inhibits Wnt signaling and hair cell formation, though its role in regeneration has not been established. We use a zebrafish kremen1 mutant line, to show that when Wnt signaling is overactivated in the lateral line, excessive regeneration occurs in the absence of increased proliferation, due to an increase in support cells. This contrasts with the previously described role of Wnt signaling during hair cell regeneration. This work will allow us to understand the biology of mechanosensory hair cells, and how regeneration might be promoted following damage.

An Analysis of Seafood Recalls in the United States, 2002 Through 2022.

This review analyzes the seafood recalls registered by the United States Food and Drug Administration (USFDA) from October 2002 through March 2022. There were more than 2,400 recalls for seafood products over this 20-year period. Biological contamination was the listed root cause for about 40% of these recalls. Almost half were designated as Class I recalls, due to the high risk of the recalled seafood to cause disease or death. Independent of the recall classification, 74% of the recalls were due to violations of the Current Good Manufacturing Practices (cGMPs) regulations. The most common cause for these seafood recalls was due to undeclared allergens (34%). More than half of the undeclared allergen recalls were for undeclared milk and eggs. Recalls for Listeria monocytogenes accounted for 30% of all recalls and were all Class I. Finfish comprised 70% of the recall incidents, and salmon was the single most recalled species (22%). Improper cold smoking treatment that resulted in Listeria monocytogenes contamination was the most common reason reported for the salmon recalls. The goal of this review was to evaluate the main causes of food safety failures within the seafood manufacturing and distribution sectors. Human errors and failures to control food safety risks during the processing of food are the main driving factors for most reported recalls in the U.S. Properly applying the Hazard Analysis Critical Control Points (HACCP) approach and procedures are needed to identify the potential food safety risks. The key to reducing the risks of human error and loss of process control is the development and implementation of an effective food safety culture program at the manufacturing facility, which must require strong senior management support at corporate and enterprise levels.

Electroencephalographic evidence of vector inversion in antipointing.

Mirror-symmetrical reaching movements (i.e., antipointing) produce a visual-field-specific pattern of endpoint bias consistent with a perceptual representation of visual space (Heath et al. in Exp Brain Res 192:275-286, 2009a; J Mot Behav 41:383-392 2009b). The goal of the present investigation was to examine the concurrent behavioural and event-related brain potentials (ERP) of pro- and antipointing to determine whether endpoint bias in the latter task is related to a remapping of the environmental parameters of a target (i.e., vector inversion hypothesis) or a shift of visual attention from a veridical to a cognitively represented target location (i.e., reallocation of attention hypothesis). As expected, results for antipointing-but not propointing-yielded a visual-field-specific pattern of endpoint bias. In terms of the ERP findings, an early component (i.e., the N100) related to the orienting of visuospatial attention was comparable across pro- and antipointing. In contrast, a later occurring component (i.e., the P300) demonstrated a reliable between-task difference in amplitude. Notably, the P300 has been linked to the revision of a 'mental model' when a mismatch is noted between a stimulus and a required task goal (so-called context-updating). Thus, we propose that the between-task difference in the P300 indicates that antipointing is associated with a remapping of a target's veridical location in mirror-symmetrical space (i.e., vector inversion). Moreover, our combined behavioural and ERP findings provide evidence that vector inversion is mediated via perception-based visual networks.

Ambulatory Same-Day Map-and-Treat Angiography for Selective Internal Radiation Therapy Using a Transradial Approach.

Historically, selective internal radiation therapy (SIRT) with yttrium-90 (Y-90) requires a two-week interval between workup and treatment (map and treat). The intervening gap between workup and treatment is used to plan for the dose required and obtain delivery of the radioactive Y-90. During the coronavirus disease 2019 pandemic, the delivery of a robust SIRT service was challenging due to unprecedented demands on all hospital services. Emergent practice changes were required to ensure this service could still be delivered to patients while retaining sufficient inpatient hospital beds and services for acutely unwell patients. In response to this, the interventional radiology team proposed the retention of a full SIRT service by removing the historical two-week interval between map and treat, delivering both components of the SIRT procedure on the same day. A traditional approach using femoral access would require a prolonged period of immobility and potentially an overnight stay. By adopting a transradial approach without sedo-analgesia, an ambulatory day-case map and treat SIRT with no post-procedure immobilisation was performed. This case report demonstrates the technical feasibility of same-day 'map-and-treat' SIRT, highlighting a paradigm shift from the conventional femoral access method and immobilisation to an 'ambulatory' approach with immediate mobilisation post-procedure.

Review and Analysis of Tuna Recalls in the United States, 2002 through 2020.

ABSTRACT: This review covers 18 years of voluntary recalls of tuna sold commercially in the United States. Recall information is a valuable indicator of failure to implement procedures for food safety. The voluntary recalls involve tuna that was fresh, frozen, processed, hermetically sealed, retorted in a shelf-stable pack (i.e., canned), and formulated into other tuna products. U.S. Food and Drug Administration regulations address the capture, processing, transportation, and sale of raw and processed seafood. These regulations include current good manufacturing practices, the Food Modernization Act, emergency permit controls, and guidelines for low-acid canned foods, seafood hazard analysis and critical control points, food labeling, and sanitary food transportation. Traceability and the food safety culture are important for successfully preventing or implementing recalls. The recalls themselves were separated into product treatment groups: uncooked products, canned shelf-stable products, and products in which tuna was used as an ingredient. The recalls were further categorized and summarized by reason or cause, such as biological and chemical contamination, undeclared ingredients, underprocessing, and foreign materials. The primary causes of recalls of the reviewed tuna products were (in order) Listeria monocytogenes, undeclared allergens, elevated histamine concentrations, and underprocessing of retorted tuna products. The recalls for elevated histamine concentrations primarily affected uncooked (raw) tuna. Recalls for Listeria contamination and the presence of undeclared allergens were primarily class I recalls, and recalls for elevated histamine concentrations and underprocessing were almost always assigned to the less serious recall class II.

Implementing an emergency department vascular access team: A quality review of training, competency, and outcomes.

Peripheral intravenous catheters are frequently used devices in emergency departments. Many patients now present with difficult anatomy and are labeled as difficult intravenous access patients. A common technology to address this challenge is ultrasound. While studies have examined the ability to train emergency staff, few have addressed how this should be done and the outcomes associated with such training. No studies were found with dedicated vascular access specialist teams in emergency departments. An emergency department vascular access specialist team was formed at a hospital in Bangor, Maine, United States to train, validate, and proctor clinicians with ultrasound-guided peripheral intravenous devices. A quality review of this process was compiled and determined that appropriate clinicians with dedicated training and guidance can achieve higher levels of procedural success. Furthermore, evidence substantiates that frequent practice is linked to a higher quality of care and that a significant need for such teams is present. This review examines how a team was implemented and its impact both department- and facility-wide. It is possible that hospitals benefit from the services of vascular access specialists to provide higher quality care. Successful implementation of such specialist teams requires foundational knowledge and skills in vascular access with ongoing quality measures to ensure competency and compliance with evidence-based practices.

Histamine Limits by Country: A Survey and Review.

Histamine is a biogenic amine and a food safety hazard, and it is the only biogenic amine regulated by statute or hazard analysis and critical control point guidance. This article reviews the regulations for histamine levels in fish in countries around the world, including maximum limits or levels and sampling procedures in different fish preparations. The maximum histamine levels, sampling plans, and fish products are listed. The country-by-country regulations for maximum histamine acceptance levels in some food products vary by a factor of 8, from 50 ppm in some countries to a maximum of 400 ppm in other countries. For similar food products, the maximum histamine levels vary by a factor of 4 (from 50 ppm to 200 ppm) in, for example, fresh tuna. The country-by-country sampling plans vary widely as well, and these, too, are covered in detail.