A Novel Ultrasound-Guided Bilateral Vagal Nerve Hydrodissection With 5% Dextrose Without Local Anesthetic for Recalcitrant Chronic Multisite Pain and Autonomic Dysfunction.

Chronic pain is a complex condition that often poses diagnostic and management challenges due to its multifactorial etiology. This case report describes a 49-year-old pastor who presented with a three-year history of chronic pain affecting multiple sites, including the neck, bilateral shoulders, thoracic region, lower back, and bilateral knees. Additionally, he experienced shortness of breath on mild exertion, which adversely affected his ability to converse and speak publicly. The patient had a rapid resting heart rate of 100-120 beats per minute, occasional palpitations, and a 24-hour electrocardiogram that confirmed 15% premature ventricular complexes with bigeminy and trigeminy. He complained of limited appetite with early satiety, intermittent nausea, and regurgitation. Despite consultations with multiple specialists, no underlying causes were identified in the cardiac, respiratory, gastrointestinal, or psychological domains. Ultrasound-guided bilateral vagus nerve hydrodissection using 5% dextrose without local anesthetics was administered three times at monthly intervals, resulting in remarkable pain relief within three months and the effects persisted at the nine-month follow-up. Tachycardia was no longer perceived, resting heart rate slowed to 70-80 beats per minute, shortness of breath improved, and public speaking ability was restored. The patient's early satiety, nausea, and reflux complaints were resolved. This case report highlights the potential effectiveness of this novel intervention for chronic pain. Further research is warranted to validate these findings and explore the mechanism of action.

Evaluation of sterile glove usage on digital tactile sensitivity using the Grating Orientation Task.

Introduction: Surgical glove use may be associated with a decrease in tactile sensitivity, with thicker gloves or double-gloving techniques further altering sensation. This study evaluates digital tactile sensitivity by use of a Grating Orientation Task (GOT) with multiple sterile gloving techniques (no gloves, single standard gloving, double standard gloving, orthopedic gloves, and micro-thickness gloves). Methods: Each participant performed the GOT at increasing grating widths until correctly noting orientation in ≥8 of 10 trials with multiple glove types or double-gloving technique. Glove order was randomly assigned and participants were blinded to the orientation and dome size. Results: All gloves except micro-thickness gloves showed increased threshold sensitivity values (i.e. worse fingertip sensitivity) when compared to control (micro:control, p = 0.105, others:control, p < 0.05). Single-layer gloves showed no significant difference in sensitivity when compared to orthopedic (p = 0.06) or double-layer latex gloves (p = 0.26). Discussion: Standard latex gloves decreased fingertip sensitivity when evaluated with the GOT. Double-layer and orthopedic latex gloves do not decrease sensitivity when compared with single-layer gloving. Micro-thickness gloves may provide similar tactile sensitivity to no surgical glove.

Effect of male parental gamma irradiation on host suitability of its F1 progeny of a lepidopteran tropical pest, Spodoptera litura (Fabr.) towards development and virulence of entomopathogenic nematodes, Steinernema thermophilum.

The suitability of F1 progeny insect larvae of the irradiated male parent, Spodoptera litura (Fabr.) for infective juveniles (IJs) of entomopathogenic nematodes (EPN), Steinernema thermophilum was assessed to comprehend the feasibility of combining EPNs with nuclear pest control tactic. As compared to the control, the IJs induced faster host mortality with reduced proliferation in F1 host larvae. IJs derived from F1 host larvae exhibited almost similar proliferation capacity on normal hosts as in control. Further, the molecular basis of EPNs induced mortality in F1 host larvae was evaluated. Dual stress of EPN infection and irradiation induced downregulation of the relative mRNA expression of antimicrobial genes and upregulated expression of antioxidative genes. A pronounced effect of EPNs in association with irradiation stress was apparent on host mortality. Radiation induced sterile F1 insect larvae of S. litura acted as a reasonably suitable host for EPNs and also provided the environment for developing viable EPNs for their potential use as biocontrol agents.

[Design and application of a disposable self-destructed and sheath-encased sterile acupuncture needle].

A kind of disposable self-destructed and sheath-encased sterile acupuncture needle is designed to efficiently solve the issues of safety and sterilization encountered in the routine operation of acupuncture. The needle consists of three components, i.e. the needle body, the sheath and the locker. The needle body is movable and rotatable in the sheath, but can not be separated from the sheath. It is convenient for the operator to perform the lifting-thrusting and twisting techniques, and to prevent the non-punctured portion of the body from being out off the sheath so that a sterile confined room is formed between the needle and the skin of the operated area. With a locker installed between the sheath and the needle handle, after needle removal, the needle body can be returned and locked in the sheath, avoiding the exposure of needle tip, obtaining the self-destruction of needle and preventing from needling accident and reuse of needle. The devise is operated easily, which is effectively reduce the risk of infection and ensure the safety of medical staffs in practice.

Novel Ultrasound-Guided Hydrodissection with 5% Dextrose for the Treatment of Occipital Neuralgia Targeting the Greater Occipital Nerve.

BACKGROUND: Occipital neuralgia is a debilitating condition, and traditional treatments often provide limited or temporary relief. Recently, ultrasound-guided hydrodissection of the greater occipital nerve (GON) has emerged as a promising minimally invasive approach. OBJECTIVES: To describe two novel ultrasound-guided hydrodissections with 5% dextrose for GON and discuss their advantages, disadvantages, and considerations. METHODS: Two cases are reported. Case 1 describes a lateral decubitus approach for hydrodissecting the GON between the semispinalis capitis (SSC) and obliquus capitis inferior (OCI) muscles. Case 2 details a cranial-to-caudal approach for hydrodissecting the GON within the SSC and upper trapezius (UT) muscles when the GON passes through these two muscles. RESULTS: Both patients experienced significant and sustained pain relief with improvements in function. CONCLUSIONS: Ultrasound-guided GON hydrodissection using 5% dextrose is a promising treatment for occipital neuralgia. The lateral decubitus and cranial-caudal approaches provide additional options to address patient-specific anatomical considerations and preferences.

An Idiopathic Sterile Thyroid Abscess in a Five-Year-Old Child.

We would like to share a case study of a five-year-old child who complained of a painful mass on the front of his neck, with a fever of 98°F. Sometimes thyroid abscesses may be overlooked due to their rarity and are lower down on our list of differential diagnoses. Neck ultrasonography confirmed our findings. A thorough analysis of the literature showed that causal bacteria are required for almost all abscesses. However, in our instance, the aspirated fluid culture revealed no growth, indicating that the abscess was sterile. When patients present with severe neck swelling, this case report emphasizes the significance of considering thyroid abscess as one of the differential diagnoses since early detection is critical to minimize the risk of complications.

Exploring the role of innate lymphoid cells in the periodontium: insights into immunological dynamics during orthodontic tooth movement.

Background: The periodontal ligament (PDL) experiences considerable mechanical stresses between teeth and bone, vital for tissue adaptation, especially in orthodontic tooth movement (OTM). While recent research emphasizes the role of innate lymphoid cells (ILCs) in regulating sterile inflammation, their involvement in periodontal tissues during OTM remains largely unexplored. Methods: In this study, PDL tissues from orthodontic patients (n = 8) were examined using flow cytometry to detect ILC subtypes. Transwell co-culture systems were used to expose PDL cells to mechanical strain, followed by measuring migration and ratios of sorted ILC subtypes. Statistical analyses were conducted using paired Student's t-test, Kruskal-Wallis test, Dunn's post-test and one-way/two-way ANOVA with Tukey's post-test (p≤ 0.05; **, p≤ 0.01; ***, p≤ 0.001). Results: Our findings demonstrate a significant increase in CD127+ CD161+ ILC frequencies in PDL tissues during OTM, indicating ILC involvement in sterile inflammation induced by orthodontic forces. Co-culture assays show directed migration of ILC subsets towards PDL cells and substantial proliferation and expansion of ILCs. Conclusions: This study is the first to comprehensively investigate the role of ILCs in sterile inflammation during OTM, revealing their presence and distribution within PDL tissues' innate immune response in vivo, and exploring their migratory and proliferative behavior in vitro. The results suggest a crosstalk between ILCs and PDL cells, potentially influencing the inflammatory response and tissue remodeling processes associated with OTM.

Sterile Diet Causes Gut Microbiome Collapse of Cancer Patients Post Hematopoietic Cell Transplantation, But Normal Diet Recovers Them.

Though sterile diet, post-transplantation surgery is a clinical strategy for patient care to prevent the infiltration of gut pathogens, less is known about its effects on the gut microbiome. Here, the gut microbiome dynamics of leukemia patients following a 120-day "sterile-normal" diet strategy posthematopoietic cell transplantation are examined. In contrast to the traditional idea, a sterile diet leads to the lowest gut microbiota diversity (p < 0.05) and short-chain fatty acids, promoted the proliferation of potential pathogens such as Streptococcus (up by 16.93%) and Lactobacillus (up by 40.30%), and 43.32% reduction in nodes and an 85.33% reduction in edges within the microbial interaction's network. Interestingly, a normal diet allows the gut microbiome recovery and significantly promotes the abundance of beneficial bacteria. These results indicate that a sterile diet leads to a collapse of the patient's gut microbiome and promoted the proliferation of potential pathogens. This assay is a starting point for a more sophisticated assessment of the effects of a sterile diet. The work also suggests a basic principle for the re-establishment of microbial equilibrium that supplementation of microbial taxa may be the key to the restoration of the degraded ecosystem.

Central lines, aseptic batching services, and infection rates: A pharmacy-led initiative of intravenous tube priming within a NICU.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: Central line-associated bloodstream infections (CLABSIs) are hospital-acquired, serious complications that greatly affect many vulnerable neonates throughout their hospital stay. This article describes the implementation of a unique practice in which pharmacy primes continuous infusions through medication tubing for neonatal central lines in a cleanroom at Children's Hospital Colorado - Colorado Springs (CHCO-CSH). SUMMARY: This institution is a freestanding children's hospital with a level III neonatal intensive care unit (NICU) that opened in April 2019. Since then, the pharmacy department has been priming central line tubing for continuous infusions for all patients in the NICU. Neonates are at increased risk for developing CLABSIs due to their immature immune systems and frequent need for central line placement. With that in mind, the pharmacy department decided to focus efforts on this population. Pharmacists and pharmacy technicians received training on how to properly prime tubing, document when a patient received a new central line, document if a central line was removed, and record when new tubing was due based on a department policy. CONCLUSION: This novel, pharmacy-led priming procedure resulted in a low CLABSI incidence, offering a promising strategy to reduce CLABSIs in a NICU.

Novel Insights into Parkin-Mediated Mitochondrial Dysfunction and "Mito-Inflammation" in α-Synuclein Toxicity. The Role of the cGAS-STING Signalling Pathway.

The prevalence of age-related neurodegenerative diseases, such as Parkinson's disease (PD) and related disorders continues to grow worldwide. Increasing evidence links intracellular inclusions of misfolded alpha-synuclein (α-syn) aggregates, so-called Lewy bodies (LB) and Lewy neuritis, to the progressive pathology of PD and other synucleinopathies. Our previous findings established that α-syn oligomers induce S-nitrosylation and deregulation of the E3-ubiquitin ligase Parkin, leading to mitochondrial disturbances in neuronal cells. The accumulation of damaged mitochondria as a consequence, together with the release of mitochondrial-derived damage-associated molecular patterns (mtDAMPs) could activate the innate immune response and induce neuroinflammation ("mito-inflammation"), eventually accelerating neurodegeneration. However, the molecular pathways that transmit pro-inflammatory signals from damaged mitochondria are not well understood. One of the proposed pathways could be the cyclic GMP-AMP synthase (cGAS) - stimulator of interferon genes (STING) (cGAS-STING) pathway, which plays a pivotal role in modulating the innate immune response. It has recently been suggested that cGAS-STING deregulation may contribute to the development of various pathological conditions. Especially, its excessive engagement may lead to neuroinflammation and appear to be essential for the development of neurodegenerative brain diseases, including PD. However, the precise molecular mechanisms underlying cGAS-STING pathway activation in PD and other synucleinopathies are not fully understood. This review focuses on linking mitochondrial dysfunction to neuroinflammation in these disorders, particularly emphasizing the role of the cGAS-STING signaling. We propose the cGAS-STING pathway as a critical driver of inflammation in α-syn-dependent neurodegeneration and hypothesize that cGAS-STING-driven "mito-inflammation" may be one of the key mechanisms promoting the neurodegeneration in PD. Understanding the molecular mechanisms of α-syn-induced cGAS-STING-associated "mito-inflammation" in PD and related synucleinopathies may contribute to the identification of new targets for the treatment of these disorders.

Comprehensive assessment of blood-brain barrier opening and sterile inflammatory response: unraveling the therapeutic window.

Microbubbles (MBs) combined with focused ultrasound (FUS) has emerged as a promising noninvasive technique to permeabilize the blood-brain barrier (BBB) for drug delivery into the brain. However, the safety and biological consequences of BBB opening (BBBO) remain incompletely understood. This study aims to investigate the effects of two parameters mediating BBBO: microbubble volume dose (MVD) and mechanical index (MI). High-resolution MRI-guided FUS was employed in mouse brains to assess BBBO by manipulating these two parameters. Afterward, the sterile inflammatory response (SIR) was studied 6 h post-FUS treatment. Results demonstrated that both MVD and MI significantly influenced the extent of BBBO, with higher MVD and MI leading to increased permeability. Moreover, RNA sequencing revealed upregulation of major inflammatory pathways and immune cell infiltration after BBBO, indicating the presence and extent of SIR. Gene set enrichment analysis identified 12 gene sets associated with inflammatory responses that were significantly upregulated at higher MVD or MI. A therapeutic window was established between therapeutically relevant BBBO and the onset of SIR, providing operating regimes to avoid damage from stimulation of the NFκB pathway via TNFɑ signaling to apoptosis. These results contribute to the optimization and standardization of BBB opening parameters for safe and effective drug delivery to the brain and further elucidate the underlying molecular mechanisms driving sterile inflammation.

[Translated article] Implementation of a traceability and safe drug preparation system in a clean room.

OBJECTIVE: To describe the process of implementing a traceability and safe manufacturing system in the clean room of a pharmacy service to increase patient safety, in accordance with current legislation. METHODS: The process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the "Good Practices Guide for Medication Preparation in Pharmacy Services" (GBPP). The following sections were parameterised in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardised work procedures, and quality controls. RESULTS: A total of 50 users, 4 elaboration areas and 113 equipments were included. 435 components were parameterized (195 raw materials and 240 pharmaceutical specialties), 54 packaging materials, 376 standardised work procedures (123 of them corresponding to sterile medicines and 253 to non-sterile medicines, of which 52 non-sterile were dangerous), in addition, 17 were high risk, 327 medium risk, and 32 low risk, and 13 quality controls. CONCLUSIONS: The computerization of the production process has allowed the implementation of a traceability and secure manufacturing system in a controlled environment in accordance with current legislation.

Modelling mosquito population suppression based on competition system with strong and weak Allee effect.

Mosquito-borne diseases are threatening half of the world's population. To prevent the spread of malaria, dengue fever, or other mosquito-borne diseases, a new disease control strategy is to reduce or eradicate the wild mosquito population by releasing sterile mosquitoes. To study the effects of sterile insect technique on mosquito populations, we developed a mathematical model of constant release of sterile Aedes aegypti mosquitoes with strong and weak Allee effect and considered interspecific competition with Anopheles mosquitoes. We calculated multiple release thresholds and investigated the dynamical behavior of this model. In order to get closer to reality, an impulsive differential equation model was also introduced to study mosquito suppression dynamics under the strategy of releasing $ c $ sterile male mosquitoes at each interval time $ T $. Finally, the relationship between the releasing amount or the waiting period and the number of days required to suppress mosquitoes was illustrated by numerical simulations.

Intestinal flora and pregnancy complications: Current insights and future prospects.

Numerous studies have demonstrated the pivotal roles of intestinal microbiota in many physiopathological processes through complex interactions with the host. As a unique period in a woman's lifespan, pregnancy is characterized by changes in hormones, immunity, and metabolism. The gut microbiota also changes during this period and plays a crucial role in maintaining a healthy pregnancy. Consequently, anomalies in the composition and function of the gut microbiota, namely, gut microbiota dysbiosis, can predispose individuals to various pregnancy complications, posing substantial risks to both maternal and neonatal health. However, there are still many controversies in this field, such as "sterile womb" versus "in utero colonization." Therefore, a thorough understanding of the roles and mechanisms of gut microbiota in pregnancy and its complications is essential to safeguard the health of both mother and child. This review provides a comprehensive overview of the changes in gut microbiota during pregnancy, its abnormalities in common pregnancy complications, and potential etiological implications. It also explores the potential of gut microbiota in diagnosing and treating pregnancy complications and examines the possibility of gut-derived bacteria residing in the uterus/placenta. Our aim is to expand knowledge in maternal and infant health from the gut microbiota perspective, aiding in developing new preventive and therapeutic strategies for pregnancy complications based on intestinal microecology.

Expediting Next-Generation Hybrid Technology in Recalcitrant Maize Inbreds through In Vivo Targeted Activity of CRISPR/Cas9.

The Manipulated Genic Male Sterile Maintainer (MGM) system, a next-generation hybrid seed technology, enables efficient production of sortable seeds from genic male sterile (GMS) lines. However, implementing robust MGM systems in commercial maize inbred lines requires stable transformation, a genotype-specific and laborious process. This study aimed to integrate MGM technology into the commercial maize inbred line Z372, developing both GMS and MGM lines. We utilized the MGM line ZC01-3A-7, which contains the MS26ΔE5 editor T-DNA and MGM T-DNA, previously established in the highly transformable ZC01 recipient plants. Through a combination of crossing and backcrossing with Z372, we targeted the fertility gene Ms26 within the Z372 genome for mutation using the in vivo CRISPR/Cas9 activity within the MS26ΔE5 editor T-DNA construct. This approach facilitated precise editing of the Ms26 locus, minimizing linkage drag associated with the Ms26 mutation. Whole-genome SNP analysis achieved a 98.74% recovery rate for GMS and 96.32% for MGM in the BC2F2 generation. Importantly, the Z372-GMS line with the ms26ΔE5 mutation is non-transgenic, avoiding linkage drag and demonstrating production readiness. This study represents a significant advancement in maize breeding, enabling the rapid generation of GMS and MGM lines for efficient hybrid seed production.

Challenges and solutions to manufacturing of low viscosity, ultra-high concentration IgG1 drug products: From late downstream process to final fill finish processing.

Challenges in manufacturing of high concentration antibody formulations have seldom been discussed. These are observed mainly form late downstream operations where antibody gets concentrated to its final strength, to final fill finish processing and containerization of the product. Present paper summarizes challenges typically observed in manufacturing and processing of high concentration antibody products and provides turnkey solutions to these typical challenges in order to have their consistent and robust manufacturing process. IgG1 has been used as model protein for studying the challenges and providing solutions to them. The late downstream challenges like increased viscosity limiting further concentration can be resolved by used of viscosity modifying agents in the formulation. Replacement of conventionally used 'A' screen membranes with 'D' screen or using single pass TFF can further provide advantage in targeting higher concentrations for same protein with lesser shear and aggregation. Using 0.5µm/0.2µm asymmetric or bilayered membrane instead of conventional 0.2µm membrane resulted in better flux while filtration of high concentration IgG1 formulation. In process holding time during filling operation was optimized to be <60min based on the nozzle drying time for high concentration IgG1 formulation. Appropriate control strategy of replacing filling nozzles and performing periodic fill weight check was proposed for fill finish process of high concentration IgG1 formulation.

Molecular evidence sterile tissue damage during pathogenesis of pododermatitis aseptica hemorrhagica circumscripta is associated with disturbed epidermal-dermal homeostasis.

Podermatitis aseptica hemorrhagica circumscripta is associated with metalloproteinase 2 weakening of distal phalangeal suspensory structures and sinkage of the distal phalanx in the claw capsule. Pressure from the tuberculum flexorium on the sole epidermis and dermis produces hemorrhagic tissue injury and defective horn production appearing as yellow-red, softened claw horn in region 4 of the sole. A model of the MAPK/ERK signal cascade orchestrating epidermal-dermal homeostasis was employed to determine if sterile inflammatory responses are linked to disturbed signal transduction for epidermal homeostasis in sole epidermis and dermis. The objective was to assess shifts in target genes of inflammation, up- and downstream MAPK/ERK signal elements, and targeted genes supporting epidermal proliferation and differentiation. Sole epidermis and dermis was removed from lateral claws bearing lesions of podermatitis aseptica hemorrhagica circumscripta, medial claws from the same limb and lateral claws from completely normal limbs of multiparous, lactating Holstein cows. The abundance levels of targeted transcripts were evaluated by real-time QPCR. Lesion effects were assessed by ANOVA, and mean comparisons were performed with t-tests to assess variations between mean expression in ulcer-bearing or medial claw dermis and epidermis and completely normal lateral claw dermis and epidermis or between ulcer-bearing dermis and epidermis and medial claw dermis and epidermis. The lesions were sterile and showed losses across multiple growth factors, their receptors, several downstream AP1 transcription components, CMYC, multiple cell cycle and terminal differentiation elements conducted by MAPK/ERK signals and ß 4, α 6 and collagen 17A hemidesmosome components. These losses coincided with increased cytokeratin 6, ß 1 integrin, proinflammatory metalloproteinases 2 and 9, IL1B and physiologic inhibitors of IL1B, the decoy receptor and receptor antagonist. Medial claw epidermis and dermis from limbs with lateral claws bearing podermatitis aseptica hemorrhagica circumscripta showed reductions in upstream MAPK/ERK signal elements and downstream targets that paralleled those in hemorrhagic lesions. Inhibitors of IL1B increased in the absence of real increases in inflammatory targets in the medial claw dermis and epidermis. Losses across multiple signal path elements and downstream targets were associated with negative effects on targeted transcripts supporting claw horn production and wound repair across lesion-bearing lateral claws and lesion-free medial claw dermis and epidermis. It was unclear if the sterile inflammation was causative or a consequence of these perturbations.

Presence of pathogen DNA in milk harvested from quarters is associated to changes in cows' milk yield and composition.

BACKGROUND: Intramammary infection is the result of invasion and multiplication of microorganisms in the mammary gland and commonly leads to mastitis in dairy animals. Although much has been done to improve cows' udder health, mastitis remains a significant and costly health issue for dairy farmers, especially if subclinical. In this study, quarter milk samples from clinically healthy cows were harvested to detect pathogens via quantitative PCR (qPCR) and evaluate changes in individual milk traits according to the number of quarters infected and the type of microorganism(s). A commercial qPCR kit was used for detection of Mycoplasma bovis, Mycoplasma spp., Staphylococcus aureus, coagulase-negative staphylococci (CNS), Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Prototheca spp., Escherichia coli, Klebsiella spp., Enterococcus spp. and Lactococcus lactis ssp. lactis. Quarter and pooled milk information of 383 Holstein, 132 Simmental, 129 Rendena, and 112 Jersey cows in 9 Italian single-breed herds was available. RESULTS: Among the cows with pathogen(s) present in at least 1 quarter, CNS was the most commonly detected DNA, followed by Streptococcus uberis, Mycoplasma bovis, and Streptococcus agalactiae. Cows negative to qPCR were 206 and had the lowest milk somatic cell count. Viceversa, cows with DNA isolated in ≥ 3 quarters were those with the highest somatic cell count. Moreover, when major pathogens were isolated in ≥ 3 quarters, milk had the lowest casein index and lactose content. In animals with pathogen(s) DNA isolated, the extent with whom milk yield and major solids were impaired did not significantly differ between major and minor pathogens. CONCLUSIONS: The effect of the number of affected quarters on the pool milk quality traits was investigated in clinically healthy cows using a commercial kit. Results remark the important negative effect of subclinical udder inflammations on milk yield and quality, but more efforts should be made to investigate the presence of untargeted microorganisms, as they may be potentially dangerous for cows. For a smarter use of antimicrobials, analysis of milk via qPCR is advisable - especially in cows at dry off - to identify quarters at high risk of inflammation and thus apply a targeted/tailored treatment.

Mesenchymal-epithelial transition factor exon 14 skipping mutation-positive granulocyte colony-stimulating factor-producing lung adenocarcinoma mimicking lung abscess: A case report.

Granulocyte colony-stimulating factor (G-CSF)-producing lung tumours are rare, with their imaging features and effective treatments remaining elusive. Similarly, mesenchymal-epithelial transition (MET) exon 14 skipping mutations are also uncommon. Herein, we report a case of G-CSF-producing lung adenocarcinoma positive for a MET exon 14 skipping mutation, mimicking lung abscess. A 61-year-old man presented with cough and high fever. Contrast-enhanced chest computed tomography revealed a mass with a cavity and internal fluid accumulation. The patient initially underwent diagnostic treatment for a lung abscess but was ultimately diagnosed with lung adenocarcinoma positive for a MET exon 14 skipping mutation. Following tepotinib therapy, the primary lesion shrank, and serum G-CSF levels decreased, leading to a diagnosis of G-CSF-producing lung cancer. G-CSF-producing lung tumours can present imaging findings that mimic lung abscesses. Tepotinib therapy may be effective for patients with MET exon 14 skipping mutation, including those with G-CSF-producing lung cancer.

Understanding individual experiences with stick-built and modular cleanrooms: Lessons learned and a call to action.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: The purpose of this study was to assess the real-world experiences of cleanroom managers and specialists who have designed, installed, and maintained stick-built and/or modular cleanrooms, delineate the advantages and disadvantages of each type of cleanroom, and gather sterile compounding cleanroom design and installation advice and lessons learned. METHODS: This study was conducted via surveys and semistructured interviews of individuals with cleanroom experience in the previous 5 years. Qualitative analyses were conducted on participants' survey and interview responses to assess their satisfaction with each type of cleanroom and to determine what they perceive to be the pros and cons of each type based on their own experiences. Key lessons learned and advice from these individuals were also extracted from their survey and interview responses. RESULTS: Fourteen individuals from 13 US states completed the survey; twelve participated in follow-up interviews. Fifty percent of the participants (n = 7) had installed 5 or more cleanrooms in the previous five years and over half (n = 8; 57%) had 7 or more years of cleanroom experience. The average satisfaction scores for each type of cleanroom, on a 1 to 10 scale, was 5.3 for stick-built (n = 11) and 9.3 for modular (n = 4). The pros of stick-built cleanrooms included greater design and material flexibility and lower up-front costs. The pros of modular cleanrooms included the cleanroom experience and expertise of modular vendors, quick and easy installations, guaranteed certification, and high-quality and durable design features and materials. Additionally, modular cleanrooms had fewer long-term maintenance issues, greater long-term flexibility, and lower indirect and long-term costs than stick-built cleanrooms. Key pieces of advice from the participants included the following: do your homework before beginning a cleanroom project; make sure heating, ventilation, and air conditioning system(s) and air handlers are adequate for your needs; and remember that the ultimate purpose of a quality cleanroom is patient safety. Participants also advocated for industry-wide cleanroom standards that go beyond USP regulations. CONCLUSION: The findings of this study confirm many of the purported pros and cons of each type of cleanroom, with further insight gained into the relative quality and costs of each type. Modular cleanrooms were considered by most participants to be a better long-term option, based on quality and lifetime costs, if feasible to install. Study participants also emphasized that designing and installing pharmacy cleanrooms is a complex and time-intensive process that often comes with a steep learning curve. While there are federal and state cleanroom standards available and consultants for hire, a comprehensive resource or manual that could provide guidance, insight, and collective lessons learned on cleanroom design and installation is needed.