bluuebunny/crossref_metadata_2025_split huggingface dataset:
Sensitive SERS Characterization and Analysis of Chlorpyrifos and Aldicarb Residues in Animal Feed using Gold Nanoparticles
Authors: Lee Kyung-min , Yarbrough Danielle , Kozman Mena , Herrman Timothy , Park Jinhyuk , Wang Rui , Kurouski Dmitry 
Published: April 2023

The spectroscopic method based on surface-enhanced Raman spectroscopy (SERS) technique combined with chemometric methods was developed for simple, cost-effective, and efficient analysis of chlorpyrifos (CPF) and aldicarb (ALD) pesticide residues in animal feed. Animal feeds free from the pesticides were spiked at different concentrations of CPF (0-20 mg/kg) and aldicarb (0-100 µg/kg). Gold nanoparticles were mixed with sample extract for SERS measurement. A significant spectral difference induced by the presence and different level of CPF and ALD concentration in animal feed was observed between the pesticide spiking groups. Different chemometric models applied on training datasets showed excellent classification rates (100 percent) while the models on external validation dataset exhibited lower correct classification rates (50.0-76.7 percent) with no false-negative error. The selected chemometric models for CPF and ALD quantification also showed a high predictive ability and performance. The developed models displayed no statistical significant difference between model predicted and reference values in the external validation dataset (p < 0.01). The study results indicate that the SERS spectroscopic method could be an effective and efficient analytical tool for pesticide analysis in highly complex animal feed matrices for screening at a point of sampling to improve food and feed safety.
https://doi.org/10.21423/jrs-v08lee
Recommendations for Assessing Human Dietary Exposure to Newly Expressed Proteins in Genetically Modified Crops
Authors: Mathesius Carey A. , Sauve-Ciencewicki Alaina , Anderson Jennifer , Cleveland Cheryl , Fleming Carrie , Frierdich Gregory E. , Goodwin Laurie , Grunenwald Mark , Laporte Frank , Lipscomb Elizabeth A. , Oberdoerfer Regina , Petrick Jay S. , Bauman Patricia A. 
Published: April 2023

Risk assessment of genetically modified (GM) crops includes an evaluation of hazard and exposure to newly expressed crop constituents, exemplified herein by newly expressed proteins (NEPs). Guidance directing dietary exposure assessments (DEAs) is limited and/or globally inconsistent. Best practices for conducting DEAs are presented and include a preliminary problem formulation step to determine if a formal DEA is necessary to support the risk assessment. If a formal DEA is deemed necessary, the type of exposure (acute or chronic) and the availability of food consumption data relevant to the targeted population should be identified. Exposure should be estimated initially using a simple, straight-forward, and fit-for-purpose DEA (unrefined DEA) approach while ensuring relevance to the risk question. Unrefined assessments, which are very likely to overestimate exposure, provide a high level of protection to consumers of GM crops. If refinement of the DEA is necessary, then the simplest refinements that meet the needs of the risk assessment should be implemented. DEAs are not scientifically necessary for NEPs in GM crops if a hazard has not been identified, since risk is a function of both hazard and exposure. Nonetheless, dietary exposure assessments are sometimes required for regulatory purposes, and this publication outlines some key best practices and considerations for their conduct.
https://doi.org/10.21423/jrs-v08mathesius
Potential Impact of Accelerated Approval on the Drug Lags for Anticancer Drugs Between the United States and Japan
Authors: Nagasawa Takashi , Aruga Atsushi 
Published: April 2023

The term 'drug lag' represents the difference in the timing of drug approval among countries. The impact of accelerated approvals on the drug lag for anticancer drugs between the United States (U.S.) and Japan was evaluated using publicly available information to identify anticancer drugs approved in the U.S. or Japan between January 2006 and March 2017. A logistic regression analysis was conducted to determine the association between the oncology drugs lags and potential factors, including accelerated approval. The median drug lag was 805 days. The drug lag was extended for drugs that were approved in the U.S. under accelerated approval (884 days) compared to the standard approval (606 days). A total of 170 approvals were available for the analysis of drug lags. A multivariate logistic regression analysis revealed that the following factors contributed significantly to the drug lags (p < 0.05): accelerated approval (odds ratio [OR] 4.48), Phase III study (OR 3.69), major cancer (OR 0.38), and international/global development (OR 0.32). Accelerated approval in the U.S. is one of the significant factors that extend the drug lags for anticancer drugs. The current drug development and approval process in Japan may have advantages, however, since a new regulation to reduce drug lag for anticancer drugs, the conditional early approval system, may help minimize drug lags and support decision making not only for regulators but also pharmaceutical companies.
https://doi.org/10.21423/jrs-v08nagasawa
Streamlining Data Requirements for the Environmental Risk Assessment of Genetically Modified (GM) Crops for Cultivation Approvals
Authors: Anderson Jennifer , Bachman Pamela , Burns Andrea , Chakravarthy Suma , Goodwin Laurie , Privalle Laura , Song Shuang , Storer Nicholas 
Published: April 2023

Genetically modified (GM) crops have been cultivated safely for more than 25 years, and the framework for conducting an environmental risk assessment (ERA) is well-established. Currently, there is alignment of broadly-stated protection goals across global jurisdictions; however, there is a lack of consistency for the data that are required by regulators. Risk assessors have over 25 years of collective experience assessing the environmental safety of GM crops and have conducted hundreds of ERAs to evaluate GM crop safety. This experience provides a scientific basis to help determine which data informs the ERA, and which data does not inform the safety assessment. The goals of this paper are to: 1) define the process for identifying potential pathways to harm based on robust problem formulation; 2) provide an overview of data that inform the science-based ERA for cultivation approval; 3) provide examples of data that are routinely or occasionally required but do not inform the ERA; and 4) make recommendations for harmonization of global ERA data requirements. Refinement and harmonization of data requirements across global regulatory authorities will add transparency and predictability to the ERA of GM crops globally, while ensuring that each country's protection goals are respected.
doi: 10.21423/jrs-v09i1anderson
Data Transportability for Studies Performed to Support an Environmental Risk Assessment for Genetically Modified (GM) Crops
Authors: M. Bachman Pamela , Anderson Jennifer , Burns Andrea , Chakravarthy Suma , Goodwin Laurie , Privalle Laura , Song Shuang , Storer Nicholas 
Published: April 2023

Laboratory and field data generated on genetically modified (GM) plants in one country can inform the environmental risk assessment and support regulatory decision-making for GM plants being cultivated in another country. Well-designed studies that test clear risk hypotheses and that follow well-established methods allow for conclusions to be made about potential environmental effects from cultivation of a GM plant relative to its conventional counterparts. Following the principle of data transportability, if no biologically relevant differences between a GM plant and its conventional counterparts are observed in one country or region, data from these studies can be used to inform the risk assessment in another country, regardless of agroclimatic zone. Similarly, if biologically relevant differences are observed in studies conducted in one country, these data can be used to assess potential environmental harm in another country. Gathering additional data for the ERA in a different country or in expanded regions may increase the weight of evidence of environmental safety, but additional field study data are only warranted if specific hypotheses of risk remain after assessing risk based on the existing data, and if they would affect the outcome of decision-making. Transportation of product data across regions has been successfully used by multiple countries to eliminate redundancy, create regulatory efficiencies and enable timely realization of the benefits of GM plants.
doi: 10.21423/jrs-v09i1bachman
Can Mass Spectrometry Analysis of In Vitro Digestion Products Improve the Assessment of Allergenic Potential of a Newly Expressed Protein?
Authors: Wang Rong , Houston Norma , Cheever Matthew L. , Geng Tao , Gillikin Nancy , McDonald Justin , Serrano Hector , Shippar Jeffrey , Tetteh Afua , Wang Yanfei , Liu Lucy 
Published: April 2023

The rigorous safety assessment conducted on genetically modified crops includes an evaluation of allergenic potential for an associated newly expressed protein (NEP). Since no single method is recognized as a predictor for protein allergenicity, a weight of evidence approach (WOE) has been adopted. In vitro digestion is a part of the WOE approach and is used to evaluate the susceptibility of a NEP to digestion by gastrointestinal proteases. In 2017, the European Food Safety Authority outlined additional digestion conditions and suggested liquid chromatography tandem mass spectrometry (LC-MS/MS) as an analytical method to detect small post-digestion peptides. This technical review paper focuses on the question of whether LC-MS/MS can aid in assessing allergenic potential of in vitro digestion products generated under the newly proposed conditions. After an extensive review, it was determined that LC-MS/MS can detect very small digestion products. However, the method cannot provide relevant information to differentiate whether these products are allergenic or non-allergenic. Therefore, the use of LC-MS/MS for a standard in vitro digestibility assessment provides no improvement in allergenicity prediction.
doi: 10.21423/jrs-v09i1wang
Application of Raman spectroscopy for qualitative and quantitative detection of fumonisins in ground maize samples
Authors: Lee Kyung-Min , Herrman Timothy J. , Nansen Cristian , Yun Unil 
Published: April 2023

The feasibility of Raman spectroscopy for qualitative and quantitative assessment of fumonisins in ground maize was investigated using the samples with concentration range of 2 to 99 mg/kg. Major Raman bands relevant to fumonisin effects on starch molecules and on increased fumonisin levels were observed in several Raman shift regions. The k-nearest neighbor (KNN) models achieved highest classification accuracies for both training (100%) and independent validation (96-100%) data. Three classification models (k-nearest neighbor, linear discriminant analysis, and partial least squares discriminant analysis) correctly classified fumonisin contaminated samples of >5 mg/kg. All chemometrics models for quantitative determination of fumonisins could explain >90% of variation in spectra data. Multiple linear regression (MLR) and partial least square regression (PLSR) models showed slightly higher predictive accuracies and lower error rates. The statistical results showed no significant difference between LC-MS/MS (liquid chromatography-tandem mass spectrometry) reference and Raman predicted data, implying some models developed have the ability to accurately predict fumonisin levels in ground maize samples for rapid screening and identification of contaminated samples. This work characterizes the capability of Raman spectroscopy as a fast screening tool for high-throughput analysis of fumonisin contaminated samples to improve food and feed safety.
Analysis of Pesticides in Olive Oil Using a Modified QuEChERS Method with LC-MS/MS and GC-MS/MS
Authors: Chamkasem Narong , Harmon Tiffany 
Published: April 2023

A simple and high-throughput screening method for the analysis of pesticides in olive oil is presented. A modified QuEChERS sample preparation method was developed to improve the extraction recovery of highly lipophilic pesticides. The acetonitrile extract of the olive oil was directly injected to LC-MS/MS, while other GC-amenable compounds were treated with the modified QuEChERS procedure for GC-MS/MS analysis. The method is an extension of the LIB 4517 to include olive oil. The average recoveries for 80 pesticides quantified by LC-MS/MS at 200, 500, and 1000 ng/g fortifying levels were 91% or better (RSD < 5.5%), while GC-MS/MS analysis demonstrated 81% or better (RSD < 7.2%) for average recovery from 59 compounds at the same spike levels. This method showed an improved recovery of several challenging lipophilicpesticides in olive oils.
Hydrazides as Potential HDAC Inhibitors: Structure-activity
Relationships and Biological Implications
Authors: Banerjee Suvankar , Baidya Sandip Kumar , Adhikari Nilanjan , Jha Tarun , Ghosh Balaram 
Published: April 2023

Abstract:
Epigenetic modulations by HDACs are associated with multiple disease conditions. In this context, HDACs play vital roles in the progression of diseases including several cancers, neu-rodegenerative diseases, inflammatory diseases, and metabolic disorders. Though several HDAC inhibitors have been established as drug candidates, their usage has been restricted because of broad-spectrum inhibition, highly toxic character, and off-target adverse effects. Therefore, specific HDAC selectivity is essential to get rid of such adverse effects. Hydrazide-based compounds have already been proven to exert higher inhibitory efficacy and specific HDAC selectivity. In this arti-cle, the detailed structure-activity relationship (SAR) of the existing hydrazide-based HDAC inhibi-tors has been elucidated to gather crucial information that can be utilized further for the develop-ment of promising drug candidates for combating diverse diseases in the future.
Endometriosis Reccurence – is Ultrasound the Solution?
Authors: Mihai Malutan Andrei , Nati Ionel-Daniel , Ciortea Razvan , Bucuri Carmen , Patricia Rada Maria , Mihaela Ormindean Cristina , Mihu Dan 
Published: April 2023

Background:
Transvaginal and transabdominal ultrasonography has become a widely used investigative method in the diagnostic workup of endometriosis, as well as for the postoperative follow-up. The variety of lesions, the distorted anatomy caused by adhesions and the fibrosis process represent the main challenges of the ultrasound evaluation. Regarding the recurrence of endometriosis, the diagnostic criteria are being imprecise, being adjusted according to the development of ultrasound techniques.

Objective and Methods:
To this study, extensive research has been performed interrogating PubMed, Embase and Web of Science databases to identify published research including patients with endometriosis who underwent surgery. Included patients had postoperative ultrasound investigations to detect evidence of endometriosis recurrence. The selected timeframe was 5 years. We conducted a literature review on ultrasound markers of endometriosis recurrence.

Results:
In this analysis, 2023 patients from 9 studies were included. The recurrence rate detected was 17.26%. The postoperative treatment was different in the selected studies and they include the administration of progesterone, oral combined contraceptives, GnRh antagonists, aromatase inhibitors and intrauterine devices with prolonged release of progesterone.

Discussion:
The recurrence rate is different in the selected studies as a result of the recurrence definition used by each author and the minimum dimension of the lesions, in case of the cystic pattern. Innovative techniques of differential diagnosis by ultrasound are proposed, one of them being the textural analysis performed by computer-aided diagnosis – CAD. In order to standardize the recommendations regarding imaging techniques, we propose an algorithm for following up with patients in the postoperative period.

Conclusion:
The transabdominal or endovaginal ultrasound performed regularly represents a key factor to determine the recurrence of endometriosis in the postoperative period and the imaging reassessment is recommended to be performed at a 6-month interval.
Radiographic and Ultrasonographic Evaluation of the Rare Sesamoid Bone of
the Elbow: Os Subepicondylare Mediale
Authors: Doğan Yahya 
Published: April 2023

Background:
Sesamoids and accessory bones are generally small-sized and oval-shaped structures whose function and pathology are not fully elucidated. Despite their small size, sesamoid bones can directly or indirectly cause diagnostic problems. Sesamoid bones are less common in the elbow region and may need to be differentiated from a lot of diagnoses such as fractures, osteochondritis dissecans, calcific tendinitis, and synovial chondromatosis.

Case presentation:
A 55-year-old female patient presented with right elbow pain. An oval mass was seen near the medial epicondyle on the radiograph. A dynamic ultrasound examination was performed to reveal the relationship between the bone mass and the surrounding tissues, especially the ulnar nerve. Due to the well-circumscribed mass, a diagnosis of os subepicodlare mediale, a rare sesamoid bone, was made in light of current literature.

Conclusions:
When a bone mass is seen in patients presenting with elbow pain, it will be useful to know and consider the sesamoid bones. In addition, ultrasonography should be performed in addition to radiography for a localized sesamoid bone in the medial region and adjacent to the ulnar nerve. Thus, the relationship of the sesamoid bone with existing and potential complaints can be revealed and correct diagnosis-treatment approaches can be applied.
GPR18 and GPR55-related Ligands Serving as Antagonists or Agonists:
Current Situation, Challenges and Perspectives
Authors: Zhang Linjie , Fang Yiwen , Hang Sijing , Wu Wenhui , Sheng Ruilong , Guo Ruihua 
Published: April 2023

Abstract:
GPCR superfamily, the largest known family of membrane receptors, consists of six
classes from A to F. GPR18 and GPR55, δ-branch of A class, had been reported to have no confirmed
endogenous ligand and were named as “orphan receptors”. Previous studies suggest that both
GPR18 and GPR55 are possibly related to the migration and proliferation of cancer cells, macrophages
and other inflammation-associated immune cells. Thus, they may be potential targets for inflammation,
cancer and analgesia therapy. In this paper, we aimed to summarize the chemical structures
and bioactivities of the agonists and antagonists of GPR18 and GPR55; moreover, we have
briefly discussed the challenges and future perspectives in this field. This review will be beneficial
for further design and synthesis of efficient agonists and antagonists towards GPR18 and GPR55-
related disease treatment.
Non-ANCA Leucocytoclasic Vasculitis Induced by Sofosbuvir/Ledipasvir
Treatment: A Case Report
Authors: Zaimi Yosra , Ayari Myriam , Ghithia Nadine , Ayadi Shema 
Published: April 2023

Background:
The development of direct-acting antivirals directed against the Hepatitis
C Virus has dramatically modified the therapeutic approach to chronic hepatic viral disease. Larger
use of such drugs has also led to increasing reports about their adverse effects. This report aimed to
describe a case of leucocytoclasic vasculitis following treatment based on the sofosbuvir/ledipasvir
regimen with complete disappearance shortly after withdrawal in a 61-year-old patient treated for
genotype 1 hepatitis C.

Case Presentation:
A 61-year-old Tunisian woman with a history of hepatitis C virus genotype 1
infection developed palpable purpura in front of low extremity articulation, five weeks after the
onset of sofosbuvir/Ledipasvir. The histological examination concluded with leucocytoclasic vasculitis,
with total disappearance three days after withdrawal. The pre-therapeutic assessment
showed no positivity of Cryoglobulinemia. Anti-neutrophil cytoplasmic antibodies (ANCA) were
negative. A sustained viral response was obtained only 5 weeks after treatment without an increase
of viral load during follow-up.

Conclusion:
There was a temporal relationship between antiviral treatment and non-ANCA skin
vasculitis. The pharmacological department concluded the imputability of antiviral treatment
(score I2B2).
Immunological Facet and Inception after Post-COVID-19 Vaccination
Authors: Ray Suman Kumar , Mukherjee Sukhes 
Published: April 2023

Abstract:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induced coronavirus disease
2019 (COVID-19) pandemic has produced an unparalleled setback for the world's economy and
health. One of the best therapies to significantly lower severe illness and mortality from SARS-CoV-2
infection is vaccination. Worldwide vaccination campaigns are being implemented. New-onset autoimmune
problems, such as immune thrombotic thrombocytopenia, autoimmune liver disorders, IgA
nephropathy, Guillain-Barré syndrome, systemic lupus erythematosus, and rheumatoid arthritis, have
recently been described more frequently after receiving COVID-19 vaccine. The creation of specific
autoantibodies, molecular mimicry, and the function of specific vaccine adjuvants all emerge to play a
significant role in autoimmunity. The post-acute sequelae of SARS-CoV-2, usually known as Long
Covid Syndrome, are beginning to be better understood in terms of the disparities in immune responses
seen in individuals with and without the condition. We anticipate that the knowledge gleaned from
several COVID-19 investigations will be put to use in research on the inflammatory mechanisms implicated
in serious and protracted illnesses, which is still a key unmet need.
An Effective Mechanism to Mitigate Packet Dropping Attack from
MANETs using Chaotic Map based Authentication Technique
Authors: Ahmed C. Atheeq , C. Altaf , Mohammad Mohammad , Mohammed Aleem 
Published: April 2023

Background:
MANET is a self-organized wireless network with no infrastructure. Especially
data transfer from one system to another system needs to be done in a secure way. In order
to provide data integrity, authentication plays an important role in data communication. RSA
and ECC are widely used algorithms in the real world, but authentication using these algorithms is
time-consuming. Towards this, various algorithms came into existence with different security
primitives. However, it is important to design an effective key agreement process with reduced
computational cost among these security mechanisms. We have designed an effective mechanism
to mitigate packet dropping attacks to secure end-to-end communication in MANET.

Objective:
The proposed light weight authentication method is based on chaotic maps that uses
Chebyshev polynomials as primitive operation.

Methods:
The methodology includes semi group property of Chebyshev polynomials and also the
discrete logarithmic problem based chaotic maps that takes less time than these existing algorithms
and evaluates with respect to attack Resilience, packet deliverya fraction, delay, throughput,
and overhead.

Results:
Simulation produces the result of the proposed mechanism and give better performance
in terms of packet delivery ratio, overhead and computational cost.

Conclusion:
Authentication based on developed mechanism consumes less time as shown in statistical
analysis and mitigates packet dropping attacks effectively than that of traditional methods
like RSA and ECC with respect to key generation mechanism.