bluuebunny/crossref_metadata_2025_split huggingface dataset:
Validation of the Thermo Scientific™ SureTect™ Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus PCR Assay for the Detection of Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus in Seafood Matrixes: AOAC Performance Tested MethodsSM 022301
Authors: Faulds Nikki , Williams Jessica , Evans Katharine , Hughes Annette , Leak Dean , Crabtree David , Prentice Nicole , Sohier Daniele , Heikkinen Pauliina , Hurskainen Emmi , Mcmahon Wendy , Cuthbert Nicole , Matthews Bailey , Ruben Lydia , Sturghill Luvie , Godawski Frank 
Published: May 2023

Abstract

Background
The Thermo Scientific™ SureTect™ Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus PCR Assay method is a real-time PCR method for the multiplex detection of Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus in seafood.

Objective
The Thermo Scientific SureTect Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus Assay was evaluated for AOAC Performance Tested MethodsSM certification.

Method
Inclusivity/exclusivity, matrix, product consistency/stability, and robustness studies were conducted to assess the method’s performance. For the matrix study, the method was validated using the Applied Biosystems™ QuantStudio™ 5 Real-Time PCR Food Safety Instrument and the Applied Biosystems™ 7500 Fast Real-Time PCR Food Safety Instrument against the U.S. Food and Drug Administration Bacteriological Analytical Manual, Chapter 9 (2004), Vibrio and ISO 21872–1:2017 Microbiology of the food chain—Horizontal method for the determination of Vibrio spp.—Part 1: Detection of potentially enteropathogenic Vibrio parahaemolyticus, Vibrio cholerae, and Vibrio vulnificus reference methods.

Results
Matrix studies showed equivalent or superior performance of the candidate method compared to the reference method and, overall, no difference between presumptive and confirmed results, except for one matrix due to high background flora. The inclusivity/exclusivity study correctly identified/excluded all strains analyzed. Robustness testing showed no statistically significant differences in assay performance under varied test conditions. Product consistency and stability studies demonstrated no statistically significant differences between assay lots with different expiration dates.

Conclusions
The data presented show that the assay constitutes a rapid and reliable workflow for the detection of V. cholerae, V. parahaemolyticus, and V. vulnificus in seafood matrixes.

Highlights
The SureTect PCR Assay method allows for fast, reliable detection of stipulated strains in seafood matrixes with results obtained in as little as 80 min post-enrichment.
Authentication of Platycladus Orientalis Leaves and Its Five Adulterants by Combination of Morphology and Microscopic Characteristics, TLC, and HPLC Analysis
Authors: Hao Jin-Hua , Xiao Ping-Ting , Duan Peng-Bo , Miao Dan-Yang , Jiang Xiao-Yu , Kuang Yu-Jia , Liu E -Hu 
Published: May 2023

Abstract

Background
Platycladus orientalis leaves (POL), as the source of the traditional Chinese medicine (TCM) Platycladi Cacumen, has frequently been found to be misused with five adulterants including Chamaecyparis obtusa leaves (COL), Cupressus funebris leaves (CFL), Juniperus virginiana leaves (JVL), Sabina chinensis leaves (SCL), and Juniperus formosana leaves (JFL).

Objective
The purpose of this study was to distinguish POL (fresh leaves) from its five adulterants (fresh leaves).

Methods
The micromorphological features in terms of transection and microscopic characteristics of POL and adulterants were captured and compared using the an microscope. Both HPLC and TLC methods for the simultaneous determination of six bioactive flavonoids (myricitrin, isoquercitrin, quercitrin, amentoflavone, afzelin, and hinokiflavone) have been developed.

Results
There were significant differences in microscopic features of transverse section and powders. The TLC results suggested that the spots of myricitrin in POL were more obvious than those in the five adulterants. The contents of myricitrin and quercitrin, or the total content of flavonoids in POL, determined by HPLC, were significantly higher than those in the adulterants.

Conclusion
POL was successfully distinguished from its five adulterants by the comparison of morphology, microscopic characteristics, and chemical profiles.

Highlights
This research provides a comprehensive morphology, microscopic identification, TLC, and HPLC analysis for authenticating POL and its five adulterants.
Seamless phase II/III design: a useful strategy to reduce the sample size for dose optimization
Authors: Jiang Liyun , Yuan Ying 
Published: May 2023

AbstractBackgroundThe traditional more-is-better dose selection paradigm, originally developed for cytotoxic chemotherapeutics, can be problematic when applied to the development of novel molecularly targeted agents. Recognizing this issue, the US Food and Drug Administration initiated Project Optimus to reform the dose optimization and selection paradigm in oncology drug development, emphasizing the need for greater attention to benefit-risk considerations.MethodsWe identify different types of phase II/III dose-optimization designs, classified according to trial objectives and endpoint types. Through computer simulations, we examine their operating characteristics and discuss the relevant statistical and design considerations for effective dose optimization.ResultsPhase II/III dose-optimization designs are capable of controlling family-wise type I error rates and achieving appropriate statistical power with substantially smaller sample sizes than the conventional approach while also reducing the number of patients who experience toxicity. Depending on the design and scenario, the sample size savings range from 16.6% to 27.3%, with a mean savings of 22.1%.ConclusionsPhase II/III dose-optimization designs offer an efficient way to reduce sample sizes for dose optimization and accelerate the development of targeted agents. However, because of interim dose selection, the phase II/III dose-optimization design presents logistical and operational challenges and requires careful planning and implementation to ensure trial integrity.
Risk of estrogen receptor–specific breast cancer by family history of estrogen receptor subtypes and other cancers
Authors: Wang Qiao-Li , Zhang Yuqi , Zeng Erwei , Grassmann Felix , He Wei , Czene Kamila 
Published: May 2023

Abstract

Background
The extent to which the risk of estrogen receptor (ER)–specific breast cancer is associated with ER status of breast cancer and other cancers among first-degree relatives is unclear.

Methods
This population-based cohort included 464 707 cancer-free women in Stockholm, Sweden, during 1978-2019. For ER-negative and ER-positive breast cancers, we estimated hazard ratios (HRs) associated with ER status of female first-degree relatives with breast cancer and of other cancers in all first-degree relatives. Associations between ER-negative and ER-positive status by family cancer history were estimated using logistic regression in a case-only design.

Results
Women with familial ER-positive breast cancer had 1.87 times (95% confidence interval [CI] = 1.77 to 1.97) higher risk of ER-positive subtype, whereas the corresponding hazard ratio for ER-negative was 2.54 (95% CI = 2.08 to 3.10) when having familial ER-negative breast cancer. The risk increased with an increasing number of female first-degree relatives having concordant subtypes and younger age at diagnosis (Ptrend &lt;.001 for both). Nonbreast cancers among first-degree relatives were associated with both ER-positive (HR = 1.14, 95% CI = 1.10 to 1.17) and ER-negative (HR = 1.08, 95% CI = 1.01 to 1.16) breast cancers. Compared with women with ER-positive breast cancer, women with ER-negative breast cancer were more likely to have family history of liver (odds ratio [OR] = 1.33, 95% CI = 1.05 to 1.67), ovary (OR = 1.28, 95% CI = 1.01 to 1.61), and testicle cancer (OR = 1.79, 95% CI = 1.01 to 3.16) but less likely to have family history of endometrial cancer (OR = 0.77, 95% CI = 0.60 to 1.00) and leukemia (OR = 0.72, 95% CI = 0.56 to 0.91).

Conclusions
Risk of ER-specific breast cancer differs according to ER status of female first-degree relatives with breast cancer and some other cancers of first-degree relatives. This family history information should be considered in the individual risk prediction for ER subtypes.
Utility of ctDNA in predicting relapse in solid tumors after curative therapy: a meta-analysis
Authors: Mittal Abhenil , Molto Valiente Consolacion , Tamimi Faris , Di Iorio Massimo , Al-Showbaki Laith , Cescon David W , Amir Eitan 
Published: May 2023

AbstractBackgroundPresence of circulating tumor DNA (ctDNA) is prognostic in solid tumors treated with curative intent. Studies have evaluated ctDNA at specific “landmark” or multiple “surveillance” time points. However, variable results have led to uncertainty about its clinical validity.MethodsA PubMed search identified relevant studies evaluating ctDNA monitoring in solid tumors after curative intent therapy. Odds ratios for recurrence at both landmark and surveillance time points for each study were calculated and pooled in a meta-analysis using the Peto method. Pooled sensitivity and specificity weighted by individual study inverse variance were estimated and meta-regression using linear regression weighted by inverse variance was performed to explore associations between patient and tumor characteristics and the odds ratio for disease recurrence.ResultsOf 39 studies identified, 30 (1924 patients) and 24 studies (1516 patients) reported on landmark and surveillance time points, respectively. The pooled odds ratio for recurrence at landmark was 15.47 (95% confidence interval = 11.84 to 20.22) and at surveillance was 31.0 (95% confidence interval = 23.9 to 40.2). The pooled sensitivity for ctDNA at landmark and surveillance analyses was 58.3% and 82.2%, respectively. The corresponding specificities were 92% and 94.1%, respectively. Prognostic accuracy was lower with tumor agnostic panels and higher with longer time to landmark analysis, number of surveillance draws, and smoking history. Adjuvant chemotherapy negatively affected landmark specificity.ConclusionsAlthough prognostic accuracy of ctDNA is high, it has low sensitivity, borderline high specificity, and therefore modest discriminatory accuracy, especially for landmark analyses. Adequately designed clinical trials with appropriate testing strategies and assay parameters are required to demonstrate clinical utility.
Central oral pulse granuloma: a case report of huge mandibular jaw lesion
Authors: Karimi Abbas , Derakhshan Samira , Aminishakib Pouyan , Saffar Hiva , Motlagh Kimia Hafezi 
Published: May 2023

Abstract
Oral pulse granuloma is a rare lesion of the oral cavity with unclear etiology. Some authors believe this lesion is a foreign body reaction to implanted food particles. In the oral cavity, most cases are found in the posterior regions of the mandible. The edentulous mandible was involved in 20 cases with oral pulse granuloma. In these cases, the premolar–molar site was the most common region. Here we present a case of a 70-year-old male with huge unilateral swelling of the mandible on the left side. This paper aims to present a case of oral pulse granuloma with wide extension, detailed clinicohistopathologic features with 2-year follow-up and a short review of reported cases.
The kinetic and magnetic energy budget of hub-filament systems during the gravitational fragmentation of molecular clouds
Authors: Camacho Vianey , Vázquez-Semadeni Enrique , Palau Aina , Zamora-Avilés Manuel 
Published: May 2023

ABSTRACT
We present a numerical study of the balance between the gravitational (Eg), kinetic (Ek), and magnetic (Em) energies of structures within a hub-filament system in a simulation of the formation and global hierarchical collapse (GHC) of a giant molecular cloud. For structures defined by various density thresholds, and at different evolutionary stages, we investigate the scaling of the virial parameter, α, with mass M, and of the Larson ratio, ${\cal {L}}_{\rm v}\equiv \sigma _{\rm v}/R^{1/2}$, with column density Σ, where σv is the 1D velocity dispersion, and R is an effective radius. We also investigate these scalings for the corresponding magnetic parameters αm and ${\cal {L}}_{\rm {m}}$. Finally, we compare our numerical results with an observational sample of massive clumps. We find that: 1) αm and ${\cal {L}}_{\rm {m}}$ follow similar α–M and ${\cal {L}}$–Σ scalings as their kinetic counterparts, although the ratio Em/Ek decreases as |Eg| increases. 2) The largest objects, defined by the lowest thresholds, tend to appear gravitationally bound (and magnetically supercritical), while their internal substructures tend to appear unbound (and subcritical). This suggests that the latter are being compressed by the infall of their parent structures, and supports earlier suggestions that the measured mass-to-magnetic flux ratio μ decreases inwards in a centrally-peaked cloud under ideal MHD. 3) The scatter in the α–M and ${\cal {L}}$–Σ plots is reduced when Ek and Em are plotted directly against Eg, suggesting that the scatter is due to an ambiguity between mass and size. 4) The clumps in our GHC simulation follow the same trends as the observational sample of massive clumps in the ${\cal {L}}$–Σ and α–M diagrams. We conclude that the main controlling parameter of the energy budget in the structures is Eg, with the kinetic and magnetic energies being derived from it.
Resolving ambiguities in the inferred star formation histories of intense [O iii] emitters in the reionization Era
Authors: Laporte N , Ellis R S , Witten C E C , Roberts-Borsani G 
Published: May 2023

ABSTRACT
Early JWST spectroscopic campaigns have confirmed the presence of strong [O iii] line-emitting galaxies in the redshift interval 7 &lt; z &lt; 9. Although deduced earlier from Spitzer photometry as an indicative of young stellar populations, some studies suggested the relevant photometric excesses attributed to [O iii] emission could, in part, be due to Balmer breaks arising from older stars. We demonstrate that this is likely the case by exploiting medium-band near-infrared JWST photometry in the Hubble Ultra Deep Field. We locate a sample of six galaxies with redshifts 8.2&lt;z &lt;8.6 for which the relevant medium-band filters enables us to separate the contributions of [O iii] emission and a Balmer break, thereby breaking earlier degeneracies of interpretation. The technique is particularly valuable since it provides photometric redshifts whose precision, $\Delta \, z\simeq \, \pm 0.08$, approaches that of spectroscopic campaigns now underway with JWST. Although some sources are young, a third of our sample have prominent Balmer breaks consistent with stellar ages of ≥150 Myr. Our results indicate that even intense [O iii] emitters experienced episodes of earlier star formation to z ∼10 and beyond, as is now being independently deduced from direct detection of the progenitors of similar systems.
New-onset of eosinophilic granulomatosis with polyangiitis without eosinophilia and eosinophilic infiltration under benralizumab treatment: A case report
Authors: Yonezawa Haruka , Ohmura Shin-ichiro , Ohkubo Yusuke , Otsuki Yoshiro , Miyamoto Toshiaki 
Published: May 2023

ABSTRACT
Eosinophilic granulomatosis with polyangiitis (EGPA) is a small- to medium-vessel necrotising vasculitis and eosinophilic inflammation. Mepolizumab, an anti-interleukin-5 (IL-5) monoclonal antibody has been approved in Japan since 2018 for refractory EGPA treatment. Benralizumab, an anti-IL-5 receptor monoclonal antibody, also has been reported to reduce the glucocorticoid dose in patients with refractory EGPA. On the other hand, several investigators have demonstrated new-onset EGPA under biologics, and it is unclear whether this treatment for severe allergic diseases can prevent the development of EGPA. Herein, we report a case of new-onset EGPA under benralizumab treatment. The patient had fever, weight loss, muscle pain, and paraesthesia, the serum eosinophil count was 0/μL, and the biopsy showed necrotizing vasculitis without eosinophilic infiltration. She was diagnosed as having EGPA and treated with high-dose glucocorticoid and intravenous cyclophosphamide, with a good response. Our case report indicates that anti-IL-5 agents may mask the development of EGPA and clinicians should be aware of the development of EGPA during anti-IL-5 agents.
Extensive ischaemic colitis–like colonic lesions in eosinophilic granulomatosis with polyangiitis
Authors: Ueda Yoshitaka , Shimada Kota 
Published: May 2023

ABSTRACT
Eosinophilic granulomatosis with polyangiitis is a rare, immune-mediated, multisystemic disorder belonging to the group of antineutrophil cytoplasmic antibody-associated vasculitides. Gastrointestinal symptoms are relatively common in patients with eosinophilic granulomatosis with polyangiitis, reportedly occurring in ∼22.3% of cases. Vasculitic necrotising lesions normally occur in the intestinal tract, and in the present case, the colonic lesions were remarkably severe and extensive. Pulse steroid therapy combined with cyclophosphamide improved the patient’s condition without any serious complications, such as intestinal perforation.
Inclusion, Diversity, Access, and Equity in Infectious Diseases Fellowship Training: Tools for Program Directors
Authors: Luther Vera P , Barsoumian Alice E , Konold Victoria J L , Vijayan Tara , Balba Gayle , Benson Constance , Blackburn Brian , Cariello Paloma , Perloff Sarah , Razonable Raymund , Acharya Kartikey , Azar Marwan M , Bhanot Nitin , Blyth Dana , Butt Saira , Casanas Beata , Chow Brian , Cleveland Kerry , Cutrell James B , Doshi Saumil , Finkel Diana , Graber Christopher J , Hazra Aniruddha , Hochberg Natasha S , James Scott H , Kaltsas Anna , Kodiyanplakkal Rosy Priya L , Lee Mikyung , Marcos Luis , Mena Lora Alfredo J , Moore Christopher C , Nnedu Obinna , Osorio Georgina , Paras Molly L , Reece Rebecca , Salas Natalie Mariam , Sanasi-Bhola Kamla , Schultz Sara , Serpa Jose A , Shnekendorf Rachel , Weisenberg Scott , Wooten Darcy , Zuckerman Richard A , Melia Michael , Chirch Lisa M 
Published: May 2023

Abstract
The Infectious Diseases Society of America (IDSA) has set clear priorities in recent years to promote inclusion, diversity, access, and equity (IDA&E) in infectious disease (ID) clinical practice, medical education, and research. The IDSA IDA&E Task Force was launched in 2018 to ensure implementation of these principles. The IDSA Training Program Directors Committee met in 2021 and discussed IDA&E best practices as they pertain to the education of ID fellows. Committee members sought to develop specific goals and strategies related to recruitment, clinical training, didactics, and faculty development. This article represents a presentation of ideas brought forth at the meeting in those spheres and is meant to serve as a reference document for ID training program directors seeking guidance in this area.
Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case
Authors: Ortega-Villa Ana M , Hynes Noreen A , Levine Corri B , Yang Katherine , Wiley Zanthia , Jilg Nikolaus , Wang Jing , Whitaker Jennifer A , Colombo Christopher J , Nayak Seema U , Kim Hannah Jang , Iovine Nicole M , Ince Dilek , Cohen Stuart H , Langer Adam J , Wortham Jonathan M , Atmar Robert L , El Sahly Hana M , Jain Mamta K , Mehta Aneesh K , Wolfe Cameron R , Gomez Carlos A , Beresnev Tatiana , Mularski Richard A , Paules Catharine I , Kalil Andre C , Branche Angela R , Luetkemeyer Annie , Zingman Barry S , Voell Jocelyn , Whitaker Michael , Harkins Michelle S , Davey Richard T , Grossberg Robert , George Sarah L , Tapson Victor , Short William R , Ghazaryan Varduhi , Benson Constance A , Dodd Lori E , Sweeney Daniel A , Tomashek Kay M 
Published: May 2023

Abstract

Background
Clinical trials initiated during emerging infectious disease outbreaks must quickly enroll participants to identify treatments to reduce morbidity and mortality. This may be at odds with enrolling a representative study population, especially when the population affected is undefined.

Methods
We evaluated the utility of the Centers for Disease Control and Prevention’s COVID-19–Associated Hospitalization Surveillance Network (COVID-NET), the COVID-19 Case Surveillance System (CCSS), and 2020 United States (US) Census data to determine demographic representation in the 4 stages of the Adaptive COVID-19 Treatment Trial (ACTT). We compared the cumulative proportion of participants by sex, race, ethnicity, and age enrolled at US ACTT sites, with respective 95% confidence intervals, to the reference data in forest plots.

Results
US ACTT sites enrolled 3509 adults hospitalized with COVID-19. When compared with COVID-NET, ACTT enrolled a similar or higher proportion of Hispanic/Latino and White participants depending on the stage, and a similar proportion of African American participants in all stages. In contrast, ACTT enrolled a higher proportion of these groups when compared with US Census and CCSS. The proportion of participants aged ≥65 years was either similar or lower than COVID-NET and higher than CCSS and the US Census. The proportion of females enrolled in ACTT was lower than the proportion of females in the reference datasets.

Conclusions
Although surveillance data of hospitalized cases may not be available early in an outbreak, they are a better comparator than US Census data and surveillance of all cases, which may not reflect the population affected and at higher risk of severe disease.
Temporal associations between use of psychoactive substances and somatic symptoms in the daily lives of people with fibromyalgia
Authors: Kuzu Duygu , Valentine Thomas R , Kratz Anna L 
Published: May 2023

Abstract

Objective
Consumption of psychoactive substances—alcohol, nicotine, caffeine, opioids, and cannabis—is common among people with fibromyalgia. Associations between the use of substances and somatic symptoms could reflect efforts to cope with symptoms, aggravation or alleviation of symptoms after the use of substances, or a combination of these. To date, no study has provided insight into temporal associations between the consumption of psychoactive substances and fluctuations in somatic symptoms. We explored whether changes in ratings of pain and fatigue (mental and physical) predicted the later use of psychoactive substances or vice versa (substance use predicting later change in symptoms).

Design
Micro-longitudinal design.

Setting/subjects
Fifty adults (88% female, 86% White, mean age of 44.9 years) with fibromyalgia.

Methods
Participants completed ecological momentary assessments of substance use, pain intensity, and physical/mental fatigue 5 times per day for 8 days.

Results
Results of multilevel models indicated that momentary increases in fatigue showed a consistent association with greater odds of later use of psychoactive substances, whereas momentary increases in pain were related to lower odds of later cannabis and nicotine use and higher odds of later alcohol use. Only nicotine use predicted later mental fatigue.

Conclusion
Findings highlight the importance of individualized interventions for symptom management or problems related to the use of psychoactive substances. We observed that although somatic symptoms predicted later use of substances, use of substances did not show appreciable effects with regard to alleviating somatic symptoms in people with fibromyalgia.