bluuebunny/crossref_metadata_2025_split huggingface dataset:
Regulatory Science Education: The Need for Generalization
Authors: Moghissi Alan , Calderone Richard , Auffret Jean Pierre , Jaeger Lisa , Longstreth Janice , McBride Dennis , Steen Tomoko , Harrison David , Garrison Destini , McDaniel Natalie , Debrah Henry , Gloutak Larissa , Shumway Douglas , Turner Deniek , Woolley Griffin , Washington Kerra 
Published: April 2023

Ever since the beginning of regulatory science, the need for relevant education has been recognized. However, after the Food and Drug Administration (FDA) officially recognized regulatory science, several universities have developed educational programs. This paper provides the results of a study to evaluate the existing education programs on regulatory science. The study identifies the generic definition of regulatory science, consisting of applied version of various scientific disciplines used in the regulatory process. The study found that the educational programs in regulatory science largely dealt with compliance with FDA regulations. In many cases, the programs used the term "regulatory affairs" to describe the regulations and how to comply with them. Based on the experience at Georgetown University, the study provides an outline for regulatory science education. The proposed educational program consists of: 1) approximately 10 topics that are relevant to most, if not all, regulatory science disciplines; 2) a summary of various regulatory science disciplines; and 3) education in specific regulatory science disciplines.
https://doi.org/10.21423/jrs-v08moghissi
A Mixed Method Program Evaluation of Annual Inspections Conducted in Childcare Programs in Washington State
Authors: Stevens Sonya 
Published: April 2023

This mixed method study used a program evaluation to assess the reliability and social validity of the focused childcare monitoring checklist used in Washington State, as well as its social validity in maintaining quality programming in licensed childcare centers. The focused monitoring checklist and interview responses were used to answer two specific research questions: (1) How do stakeholders describe the value, usefulness, and effects of state administrated focused monitoring?; and (2) What is the inter-rater reliability of the focused monitoring tool used to assess the foundational health and safety issues that must be met by state licensed early childhood programs? The study found that licensors and providers found the focused monitoring tool as more efficient and informative than the current differential monitoring system. The use of a checklist focusing on real time compliance increased the value placed on the relevance of the inspection with respect to meeting licensor and provider needs. The results also showed that even with a controlled tool, performance of onsite inspections can vary greatly along a continuum of reliability and objectivity due to licensor rater drift and individual perceptions of licensing procedures. Licensing agencies should consider further evaluation of the monitoring process and the reliability of the checklist tool as the process is implemented statewide, concentrating on the training content and training methods provided to licensors.
https://doi.org/10.21423/jrs-v08stevens
Reevaluation of the Embryonic Stem Cell Test
Authors: Inselman Amy L. , Nolen Greg T. , Chang Ching-Wei , Harrouk Wafa , Fisher J. Edward , Tassinari Melissa S. , Hansen Deborah K. 
Published: April 2023

In recent years there has been a heightened interest in developing alternative toxicity testing methods that enhance the current system that relies almost exclusively on whole-animal testing to include in vitro assays focused on defined pathways. The embryonic stem cell test (EST) is one alternative that has been suggested for use in developmental toxicity testing. The EST utilizes the D3 mouse embryonic stem cell line to assess sensitivity of chemicals on differentiating cardiomyocytes. Additionally, a BALB/3T3 line is used to monitor cytotoxicity and compare sensitivities between adult and embryonic cells. We have reevaluated the EST nearly 10 years after formal validation by the European Center for the Validation of Alternative Methods (ECVAM) to test the stability and reliability of the cell lines in predicting developmental toxicity. Eight compounds from the ECVAM validation including the positive control, 5-fluorouracil, and the negative control, penicillin G, were tested. All eight compounds matched the classification reported during validation, indicating comparable responses and transferability of the experimental protocol. However, an increased sensitivity of the cell lines, identified by lower ID50 and IC50 values, was observed for many of the chemicals when compared to the results from the ECVAM validation.
Manual of Good Practices for Food or Feed Recalls
Authors: Correa Lizarazo Diana Ximena , Fano Castro Paola Aurora , Lopez Cristina , Ramirez Garcia Paula Josefa , Molins Ricardo , Herrman Timothy J 
Published: April 2023

Product recall is a fundamental food safety risk management tool. The key to successful implementation of a recall is recognizing the importance of shared responsibility between government/competent authority and industry. Within the recall process, the main objective for the competent authority is to protect public health by ensuring the rapid removal of unsafe foods or feeds from the market. To address the impact of a globalized food supply on the facilitation of recalls, competent authorities around the world have adopted regulations addressing product tracing through the food supply chain, clarifying responsibilities within the recall process, mandatory recall authority for food safety agencies, and disposal of contaminated products. During the recall process, the key areas in which the competent authority plays a vital role include: Communication; Coordination, Initiation and Completion of the Recall Process; Evaluation of Effectiveness of the Recall Process; Data collection, and Providing Guidance and Training to Industry and other Stakeholders.
The Establishment of Performance Verification Procedures for Fourier Transform Infrared Spectrometers
Authors: Lanzarotta Adam , Witkowski Mark , Andria Sara , Crowe John 
Published: April 2023

An integral part of any laboratory Quality Management System (QMS) is the ability to verify an analytical instrument0s performance prior to analyzing ocial samples. Performance verification procedures provide the instrument user the means to assess whether a system is functioning properly. They are a routine predetermined set of tests and acceptance criteria that can be provided by the instrument manufacturer and/or established by the laboratory itself. Performance verification procedures that have been established for a Fourier transform infrared (FT-IR) microscope system outfitted with a macro sampling accessory allow the user to determine the daily and/or annual functionality of the instrument. Specifications were established for the IR microscope operating in transmission, reflection/absorption (R/A) and attenuated total reflection (ATR) sampling modes. The specifications for the macro sampling accessory were established for transmission and ATR sampling modes only. The acceptance criterion for each performance verification specification was calculated from a series of measurements made using each accessory and sampling mode. The performance verification procedures, as well as their associated specification and acceptance criteria described in this study, are general enough that they can be applied to FT-IR instruments from dierent manufacturers.
Qanat's hydraulic harim determination using the meshless numerical method
Authors: Mohtashami Ali , Al-Ghafri Abdullah Saif , Akbarpour Abolfazl 
Published: April 2023

Abstract
Qanat is an ancient water harvesting technology which is used for irrigation, agriculture and drinking in many countries of the world. A key element of preserving this heritage is calculating their protection area. In this study, the main aim is depiction of the hydraulic harim of qanat with the usage of the meshless numerical method. Afterward, the qanat package has been added to this model to delineate the hydraulic harim of the qanat. Two qanat systems are shown here: one in a standard aquifer and the other in a real test case, namely Haji-Abad qanat, located in the Birjand unconfined aquifer. In the real test case, the hydraulic harim of Haji-Abad qanat with 10 collection shafts is depicted in 3 time sections as well. The time sections are 3 years after extraction (2014), 6 years (2017) and 11 years (2022). The findings stated that time makes the harim area larger. In addition, the hydraulic harim is extended to areas with a higher hydraulic conductivity coefficient. Ultimately, we have delineated the hydraulic harim for 2040 and unfortunately, it is influenced by buildings. Therefore, it is necessary to find the hydraulic harim of qanats in order to protect this traditional heritage.
Efficient adsorption of nickel and chromium(VI) from aqueous solutions using lignocellulose nanofibers: Kinetics, isotherms, and thermodynamic studies
Authors: Sheikhi Meghdad , Rezaei Hassan 
Published: April 2023

Abstract
The entry of heavy metals due to industrial activities into the environment is one of the major problems in this century. Nickel and chromium(VI) are the toxin elements that are used in various industries. In this study, lignocellulose nanofiber was purchased from the Nano-Novin Polymer Company (Gorgan, Iran) and used as an adsorbent for the removal of nickel and chromium(VI) ions from aqueous solutions in a batch system. The effects of pH, initial concentration, adsorbent dose, contact time, and temperature were investigated. The adsorption mechanism was determined by Langmuir, Freundlich, kinetic, and thermodynamic models. Investigation of equilibrium isotherms nickel and chromium(VI) showed that the isotherm fitted well with the Freundlich model. The pseudo-second-order model with the larger correlation coefficient had a greater fitness against experimental data in the kinetic studies. Thermodynamic parameters of both nickel and chromium such as Gibbs free energy, enthalpy, and entropy were calculated which indicated spontaneous, endothermic, and random processes, respectively. Lignocellulose nanofiber can be suggested as a good adsorbent that is highly capable of adsorbing nickel and chromium(VI) from aqueous solutions.
Post-coronary Artery Bypass Graft Complications; Potential Causes and Risk
Factors
Authors: Marzoog Basheer Abdullah , Alexandrovich Karpunkin Oleg , Nikolaevich Tremasov Maxim , Vladimirovich Kostin Sergey 
Published: April 2023

Background:
Cardiovascular disease (CVD) remains the leading cause of death worldwide despite the coexistence of the current COVID-19 pandemic. Current emergency management involves revascularization of the coronary arteries.

Aims:
Retrospectively evaluate the association between the used number of shunts and postoperative complications.

Objectives:
Several complications are reported after coronary artery bypass graft (CABG) surgery, such as postoperative arrhythmia and postoperative stroke. However, the risk factors for the development remain not elaborated.

Materials and Methods:
A retrospective cohort study involved 290 patients for the period 2017-2021 treated surgically for ischemic heart disease. The surgery includes shunts of the internal thoracic arteries with the post-occlusion coronary arteries. The number of shunts is varied depending on the size and number of occluded arteries. According to the number of shunts, the patient may be operated on with artificial circulation (CPB; cardiopulmonary bypass), or without a working heart (OFF pump; without artificial circulation. For statistical analysis, T-test, one-way ANOVA test, X2 test, COX proportional hazards, and Pearson correlation test were used by using the Statistica program.

Results:
The most frequently reported complication is postoperative hydrothorax, in 28 (11.20%) patients. Patients with post-CABG LV aneurysm had a longer CPB time and aortic cross-clamp time, t-value -5.58113, p < 0.000000; t-value -4.72802, p < 0.000004, respectively. Patients with postoperative hydrothorax with low BMI and longer CPB and Aortic cross-clamp time, t-value of-2.33929, p <0.020021; t-value 3.83233, P < 0.000157; t-value 2.71109, p < 0.007119, respectively. Subsequently, post-operative hydrothorax increases the intensive care unit (ICU) and total hospitalization days, t-value 5.80811, p < 0.000000; t-value 7.37431, p < 0.000000, respectively. Patients who have preoperative progressive angina have a higher number of complications, t-value of 2.108504, p < 0.035866. Post-myocardial infarction patients with myocardial sclerosis (PMIMS) have a higher number of complications, t value of 2.516784, p < 0.012396. A direct correlation between the number of complications and age/CPB time/ aortic cross-clamp time/ICU hospitalization days/total hospitalization days, r= 0.138565, 0.204061, 0.162078, 0.487048, 0.408381; respectively.

Conclusion:
Postoperative complication rate associated with the pre-existence of progressive angina and PMIMS. Elderly people undergoing CABG are at higher risk of psychosis, arrhythmia, longer total and ICU hospitalization days, and stroke. Advanced age, longed CPB time, prolonged aortic cross-clamp time, long ICU hospitalisation, and long total hospitalization days are risks of more frequent post-CABG complications.

Others:
The number of complications is not associated with the dead and alive status of patients or with the number of shunts.
Merrifield Resin Supported Ionic Liquids: Catalytic Applications in Organic
Synthesis
Authors: Aggarwal Ayushi , Singh Avtar , Chopra Harish Kumar 
Published: April 2023

Abstract:
Ever since their discovery, Ionic Liquids have raised great interest in organic
transformations ranging from solvents to catalytic entities. These belong to a class of nonmolecular
compounds composed of ions having curiously low melting points. In the last few
years, the Supported Ionic Liquids have drawn the attention of researchers and chemists due
to their advantages over homogeneous catalysis. The most commonly used support for immobilized
ionic liquids is polymeric. Due to its efficient recovery, reusability and chemical
inertness, Merrifield resin can be considered an excellent solid support for ionic liquids. The
present review summarizes the synthesis and application of Merrifield Resin Supported Ionic
Liquids (MRSILs). The MRSILs can be synthesized by the immobilization of amines like
ammonium, choline, imidazolium, DABCO, DMAP, pyridine, and many other functionalized
precursors. Additionally, these MRSILs play an incredible role in the field of catalysis, where
both metal-free and metal-containing MRSILs are embodied as a catalyst.
The Phytochemical and Pharmacological Properties of Citrus sinensis
‘Maltese Half-blood’ Essential Oil Peels Extracted and Optimized by
Response-surface Methodology
Authors: Kallel Imen , Tarhouni Nidhal , Elaguel Asma , Mekrazi Saoussen , Khabir Abdelmajid , Hadrich Bilel , Bayoudh Ahmed 
Published: April 2023

Background:
Citrus fruits have been a valuable economic crop for thousands of years.
Furthermore, citrus essential oils are significant in the perfume, food, and beverage sectors, as well
as aromatherapy and medical medicines.

Aims:
The present study aims to evaluate the phytochemical and pharmacological potentials of the
optimized Citrus sinensis ‘Maltese half-blood’ essential oils peels (CsEO) extraction yields using
Response-Surface Methodology (RSM).

Objective:
There have been few investigations on Citrus sinensis ‘Maltese half-blood’ essential
oil.

Methods:
Citrus sinensis ‘Maltese half-blood’ essential oil peels (CsEO) extraction yields were
performed by hydro-distillation and optimized by using Response-Surface Methodology (RSM).
The oils were analysed by GC-MS. Different chemical tests were used to evaluate antioxidant
activities. The healing potential was evaluated using models’ wounds on Wistar rats.

Results:
The RSM optimization demonstrated the highest yield of CsEO of 6.89 g/100 g d.b. All
three tested factors significantly influenced the CsEO extraction yield: washing saline solution
concentration, washings number, and drying percentage of peels. Significant antioxidant activities
were noted in CsEO: the DPPH assay reported an IC50 of 0.225 ± 0.014 mL/mg, the FRAP assay
showed an IC50 of 0.235 ± 0.001, and the NO assay was an IC50 in order of 0.259 ± 0.019. CsEO
was not genotoxic and considerably decreased the levels of DNA lesions induced by oxidants.
Also, applying a cream with CsEO on wounds promotes significantly rapid wound healing.

Conclusion:
CsEO could be considered a rich natural source of antioxidants and bio-compounds
to accelerate wound healing. It can be used in pharmaceutical sectors as an alternative to synthetic
chemicals.
Covid-19 Prevention and Treatment by Targeting Fc-fusion
Proteins: An Experience to Fight Emerging Diseases
Authors: Zare Hamed , Farkhondeh Tahereh , Bakherad Hamid , Sharifi Hengame , Hosseinzade Shirzeyli Maryam , Samarghandian Saeed , Ghasemi Fahimeh 
Published: April 2023

Abstract:
The coronavirus disease 2019 (Covid-19) pandemic has been considered a
major threat to human health. Effective therapeutic approaches are urgently required.
Spike protein and the Angiotensin-converting enzyme 2 (ACE2) receptors have critical
roles in SARS-CoV-2 infection. As a result, these two proteins are considered potential
targets for the development of a wide variety of biotherapeutics and vaccines for
controlling Covid-19. The fusion proteins have desirable medicinal properties, including
high serum half-life, stability, and solubility in the body. Moreover, other Fc-fusion
proteins used to treat other diseases have no known side effects. These Fc-fusion
proteins are valuable biopharmaceuticals and have been proposed as therapeutic
candidates for the treatment and prevention of Covid-19 owing to their potential
therapeutic benefits.
Micro and Nano Robotics-assisted Targeted Drug Delivery, Surgery and
Radiotherapy for Cancer Treatment
Authors: Ojha Smriti , Bhusan Singh Raj , Shukla Amrita , Chadha Hina , Mishra Sudhanshu 
Published: April 2023

Abstract:
Cancer refers to the progressive abnormal cell growth with the potential to invade or
spread to other parts of the body. Many cancer therapies continue to be based on systemic chemotherapy
along with radiation therapy. Numerous nanomedicine strategies have been developed to address
the untargeted nature of these therapies and the serious side effects they can cause. As targeted
therapeutic delivery is still difficult, engineered robots and microrobots are getting more and more
attention and applicability. Microrobots can more effectively reach malignancies because of their
unique features and functions, like their motility, which allows them to penetrate malignant tissues.
Modern cancer treatment techniques built on information technology can boost patient compliance
and improve patient survival. The delicate tissue can be overly damaged by radiation and surgery,
and most chemotherapy medications are unable to penetrate the blood-brain barrier and reach the tumor.
Cancer prevention, its early detection, quick diagnosis, and prompt treatment are very crucial.
Robotic technology is employed in a variety of medical settings, and its applications in surgery have
evolved that have an impact on the field of cancer treatment as well. A key improvement in cancer
therapy with the aid of robotics would be the ability to target and deliver medications directly to the
tumor.
Food Additives: Recent Advances and Development
Authors: Kaur Simranjeet , Kaur Simran , Chauhan Pratik N. , Alsayadi Galal Mohsen Hussein , Ul Hamid Junaid 
Published: April 2023

Abstract:
For instance, antifoam compounds are used at concentrations ranging from a few ppm
to a particular percentage of the product's total weight. They can either work together in a synergistic
way to benefit one another or compete with one another. In order to "prohibit the use of
additives in foods that have not been adequately studied to ensure their safety," the Food, Drug,
and Cosmetic Act was modified in September 1958. Any substance whose intended use causes it
to become a component of or to significantly alter the properties of food is considered a food additive
(including any substance intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food; and any source of radiation
intended for any such use). There are several well-known benefits to using additives. A wider
range of food products, a reduced cost of food, and a safer and more nutrient-dense food supply
are just a few of the significant advantages. Early American laws created the concept of "Generally
Recognized as Safe" for particular dietary components, which was later clearly defined to
include scientific data. The Code of Federal Regulations contains additional provisions pertaining
to specific food additives. The use of food additives in member nations is governed by three
key directives in the European Union. Australia and New Zealand follow the same legal system
as Europe. In contrast to chemical additions, which must adhere to tight regulations, natural
source additives are handled differently in Japan. This review provides general information on
how additives can be used to achieve a variety of goals and how to draw conclusions from a
range of authorities for distinct categories.
Thyroid Nodules Classification using Weighted Average Ensemble and DCRITIC
Based TOPSIS Methods for Ultrasound Images
Authors: Sharma Rohit , Kumar Mahanti Gautam , Panda Ganapati , Singh Abhishek 
Published: April 2023

Background:
Thyroid disorders are prevalent worldwide and impact many people. The abnormal growth of cells in the thyroid gland region is very common and
even found in healthy people. These abnormal cells can be cancerous or non-cancerous, so early detection of this disease is the only solution for
minimizing the death rate or maximizing a patient's survival rate. Traditional techniques to detect cancerous nodules are complex and timeconsuming;
hence, several imaging algorithms are used to detect the malignant status of thyroid nodules timely.

Aim:
This research aims to develop computer-aided diagnosis tools for malignant thyroid nodule detection using ultrasound images. This tool will be
helpful for doctors and radiologists in the rapid detection of thyroid cancer at its early stages. The individual machine learning models are inferior
to medical datasets because the size of medical image datasets is tiny, and there is a vast class imbalance problem. These problems lead to
overfitting; hence, accuracy is very poor on the test dataset.

Objective:
This research proposes ensemble learning models that achieve higher accuracy than individual models. The objective is to design different
ensemble models and then utilize benchmarking techniques to select the best model among all trained models.

Methods:
This research investigates four recently developed image transformer and mixer models for thyroid detection. The weighted average ensemble
models are introduced, and model weights are optimized using the hunger games search (HGS) optimization algorithm. The recently developed
distance correlation CRITIC (D-CRITIC) based TOPSIS method is utilized to rank the models.

Results:
Based on the TOPSIS score, the best model for an 80:20 split is the gMLP + ViT model, which achieved an accuracy of 89.70%, whereas using a
70:30 data split, the gMLP + FNet + Mixer-MLP has achieved the highest accuracy of 82.18% on the publicly available thyroid dataset.

Conclusion:
This study shows that the proposed ensemble models have better thyroid detection capabilities than individual base models for the imbalanced
thyroid ultrasound dataset.