Real Evidence Research Articles

Investigating the Regulatory Process, Safety, Efficacy and Product Transparency for Nutraceuticals in the USA, Europe and Australia.

Increased numbers of patients with chronic conditions use nutraceuticals or food-based therapeutics. However, to date, there is no global consensus on the regulatory processes for nutraceuticals. With the increased use, issues of quality and safety have also arisen. This review summarises the current regulations held for nutraceuticals in the USA, European and Australian jurisdictions using regulatory authority sites and databases. The efficacy and safety concerns, product development, gaps in regulation and challenges in ensuring product authenticity are also summarised. The data highlight the complexity that the globalisation of nutraceuticals brings with respect to challenges in regulation and associated claims regarding efficacy and safety. The development of an effective system with integrity is needed to increase vertical collaboration between consumers, healthcare practitioners, and government agencies and the development of international risk assessment criteria and botanical compendia. This will help in greater transparency and improved trust in the process and products. Emerging technologies could play a role in improving systems engineering by information sharing and leveraging the strengths of different countries. In conclusion, nutraceuticals have been poorly regulated leading to spurious claims based on little or no real evidence. This makes it difficult to separate meaningful results from poor data. More stringent regulation and an effective system of integrity are required to ensure efficacy and safety and enable the adequate monitoring and increase consumer and healthcare professionals' confidence.

The Influence of Digital Transformation and Supply Chain Integration on Overall Sustainable Supply Chain Performance: An Empirical Analysis from Manufacturing Companies in Morocco

This study examined the association between digital transformation (DT), supply chain integration (SCI), and overall sustainable supply chain performance (OSSCP). The current literature has preliminarily explored the concepts of DT and SCI and their relationship with sustainable supply chain performance. However, real empirical evidence of the direct impact of DT and SCI on OSSCP has been missing so far. To fill this gap, data were collected from 134 professionals working in international manufacturing companies operating in Morocco through a questionnaire-based survey from August 2022 to November 2022. A conceptual framework was developed based on DT, SCI, and OSSCP and analyzed by partial least squares structural equation modeling (PLS-SEM) with the assistance of SmartPLS 4.0 software. The findings revealed that DT has a significant positive influence on SCI and OSSCP. Furthermore, SCI directly and positively impacts OSSCP with a partial mediation effect on the relationship between DT and OSSCP. Further, this research provides insights for practitioners into enhancing sustainable supply chain performance by adopting digital technologies and integrating SC functions. In particular, this study revealed that DT adoption drives a higher ethical supply chain level from the perspective of sustainability and efficiency in operations. This study is the first to analyze the influence of digital transformation and supply chain integration on sustainable supply chain performance in a manufacturing context.

Pengembangan Potensi Desa Wisata Buayan Kecamatan Buayan Kabupaten Kebumen melalui Media Sosial

<p align="justify"><em><em>Community Service Program (KKN) is the real evidence of the implementation of the Tri Dharma of Higher Education, namely in the aspect of community service. Through KKN activities in Buayan Village, it is hoped that there will be synergy between universities and the community as a form of community empowerment towards a post-Covid-19 pandemic based on Sustainable Development Goals (SDGs). The purpose of this activity is to help increase the understanding and ability of Bina Sejahtera Buayan village-owned enterprise (BUMDes) managers in promoting the potential of tourism villages through social media. In addition, this activity is also expected to expand the promotion of top products of the village so that they can support village tourism and increase the village s original income (PADes). Community service activities based on the KKN work program are carried out offline by providing digital branding training to village officials and BUMDes managers in promoting and publicizing the tourism potential of Langen Ujung Baths in Buayan Village, Buayan District, Kebumen Regency. In addition, visits and assistance are also carried out to promote UMKM products through social media to support the existence of this tourist village.</em></em></p>

Fact and its significance in new media

Modern journalism has become technogenic. A new trend is emerging on the Internet every week or every month and is finding its audience and service space. The old and the new are fighting. Literature turns thought into an image and makes it beautiful, journalism relies on facts and real evidence. The two spheres also serve to build the political, social, spiritual and cultural foundation and build the walls without destroying the values in the society. A person expresses his opinion by speaking and writing. If it is possible to suppress and hide thoughts in allegorical and allusive genres, the media communicate openly with the audience face to face, and if the disputing party does not agree to mediation, it goes to court. The article deals with this and the issues arising from it. This article focuses on the journalist’s legal literacy and discusses some issues that increase professionalism and improve skills

Hidden attractors in Chua circuit: mathematical theory meets physical experiments

After the discovery in early 1960s by E. Lorenz and Y. Ueda of the first example of a chaotic attractor in numerical simulation of a real physical process, a new scientific direction of analysis of chaotic behavior in dynamical systems arose. Despite the key role of this first discovery, later on a number of works have appeared supposing that chaotic attractors of the considered dynamical models are rather artificial, computer-induced objects, i.e., they are generated not due to the physical nature of the process, but only by errors arising from the application of approximate numerical methods and finite-precision computations. Further justification for the possibility of a real existence of chaos in the study of a physical system developed in two directions. Within the first direction, effective analytic-numerical methods were invented providing the so-called computer-assisted proof of the existence of a chaotic attractor. In the framework of the second direction, attempts were made to detect chaotic behavior directly in a physical experiment, by designing a proper experimental setup. The first remarkable result in this direction is the experiment of L. Chua, in which he designed a simple RLC circuit (Chua circuit) containing a nonlinear element (Chua diode), and managed to demonstrate the real evidence of chaotic behavior in this circuit on the screen of oscilloscope. The mathematical model of the Chua circuit (further, Chua system) is also known to be the first example of a system in which the existence of a chaotic hidden attractor was discovered and the bifurcation scenario of its birth was described. Despite the nontriviality of this discovery and cogency of the procedure for hidden attractor localization, the question of detecting this type of attractor in a physical experiment remained open. This article aims to give an exhaustive answer to this question, demonstrating both a detailed formulation of a radiophysical experiment on the localization of a hidden attractor in the Chua circuit, as well as a thorough description of the relationship between a physical experiment, mathematical modeling, and computer simulation.

Scientific evidence for the effectiveness of primary and secondary (screening) prevention of cervical cancer

The evidence of HPV vaccination effectiveness is overwhelming. The randomized clinical trials showed that all three vaccines currently in use, bivalent (CERVARIX), quadrivalent (GARDASIL) and nanvalent (GARDASIL9) effectively prevent HPV infection, cervical intraepithelial neoplasia (CIN) 1–3 and invasive cervical cancer. The results of clinical trials have been confirmed by real life evidence – population data from countries were vaccination of 12–13 girls started in 2006–08. HPV vaccination is safe. This is proven by long term follow up of the cohorts of vaccinated women. In 2020 the WHO Director-General has issued a call for action to eliminate cervical cancer as a public health problem. The document includes the interim targets for 2030: vaccination of 90% of girls by 15 years; HPV testing based screening at age 35 and 45 of 70% of women; treatment of 90% of women with screening detected cervical pathology; treatment of 90% of women with precancerous lesions and cancer of the cervix. Under elimination of cervical cancer WHO means the decrease in its incidence down to 4 cases per 100 000 population. This goal will be achieved by 2030 in countries that started HPV vaccination 15 years ago in 2006–2007.In Russia incidence of cervical cancer is on increase since 1993 from 10, 2 to 16, 1 in 2018. It is predicted that the increase will continue and in 2030 the age standardized incidence rate will reach 20 per 100 000 women. HPV vaccination and HPV test based screening will change the direction of the trend from increase to decrease and save several hundreds of lives

Comparative analysis on the performances of implementing compulsory and advocative policies in municipal solid waste classification

China, the world's second largest economy, has been facing a growing municipal solid waste (MSW) disposal problem. How to choose and implement the MSW classification policy in line with China's national conditions is very important to alleviate the predicament of MSW. However, the existing literature has not comprehensively and systematically compared the impact of compulsory and advocative policies on the effectiveness of MSW classification. To this end, Polynomial Distributed Lag (PDL) model is established to compare and predict the overall implementation effects of the two types of policies on front-end classification, mid-end transportation and terminal-end processing and treatment. The empirical investigation applies PDL model and takes Shanghai and Tianjin cities as case studies to forecast MSW policy performance in 2021–2025. The results show that the implementation performance of the compulsory MSW classification policy is generally better than the advocative policy, which is manifested in the speed of policy advancement, the classification rate and growth rate of various types of MSW, the utilization rate of MSW recycling and the economic benefits. However, in terms of mid-end clearance and transportation efficiency and facility construction, advocative policy appears to perform better than compulsory policy. The overall compliance rate of MSW classification in Shanghai increased from 28% to 77%, while that in Tianjin increased from 9% to 15%. By 2025, the amount of recyclable waste in Shanghai will account for 76.9% of the total MSW classification, which is more than five times higher than the advocative policy. Shanghai's annual output value of converting recyclable waste into various renewable resources or products through resource production can reach 227.613 billion or even to 341.368 billion yuan, far exceeding Tianjin's. Based on these findings, this paper puts forward countermeasures and suggestions for optimizing the policy system of MSW classification. This study provides empirical examples of China based on real data evidence and contributes to the literature on environmental science and MSW classification policy.

Preliminary considerations for electronic medical record (EMR) in the public hospitals of Gandaki province in Nepal

Electronic Medical Record (EMR) is the digital tool to keep records of valuable information on computer or computer-like equipment, regarding health systems, including patient’s records and stock management which can provide real time evidence for better patient record, clinical care and health policy making. As Nepal does not have a national EMR system, and it is a challenge to get real time data, information and evidence required for effective health policy making. With an effective national EMR system in Nepal, the health system can be improved with reliable information of patients for the continuity of clinical care.
 
 There are existing scientific evidence of EMR on the lessons of implementation in Nepal, opportunities for the use of EMR in Malaysia, perspectives of health care workers on EMR after its implementation in Canada, on the development of success measuring tools and the use of questionnaires for the EMR implementation in Canada, best practices, impact of EMR on physician practice, and barriers for EMR implementation.
 
 EMR can improve the quality, effectiveness, transparency and efficiency of healthcare services and its management. Gandaki province is one of seven provinces in Nepal and is exploring ways to implement EMR in all the hospitals operated under the province government. There can be step wise approach to have EMR in all of these hospitals. This can give more strategies for the national EMR system.

Feminism and marginalized black women in the Hood Feminism novel by Mikki Kendall

The purposes of this study are to find out gender inequality and racism cases experienced by the author in Hood Feminism novel. There are some cases related to gender inequality, such as, patriarchal ideology, violation and discrimination against a community, while racism cases cover poverty, gun violence, hunger, injustice, and inadequate education to marginalized communities. The cases that have been studied are then linked with other cases of the same nature from one chapter to another based on Black Feminism approach, so that later conclusions can be drawn from the research. With the obstacles and burdens in carrying out these efforts, this novel becomes interesting to study. The main character in the novel herself also plays a role in the effort to get her rights as black woman. The experience of the main character in the novel is also a supporting factor that creates real facts or evidence, which is also a representation of her own experience that occur in the environment of the community.

Poisonous Piperidine Plants and the Biodiversity of Norditerpenoid Alkaloids for Leads in Drug Discovery: Experimental Aspects.

There are famous examples of simple (e.g., hemlock, Conium maculatum L.) and complex (e.g., opium poppy, Papaver somniferum L., Papaveraceae) piperidine-alkaloid-containing plants. Many of these are highly poisonous, whilst pepper is well-known gastronomically, and several substituted piperidine alkaloids are therapeutically beneficial as a function of dose and mode of action. This review covers the taxonomy of the genera Aconitum, Delphinium, and the controversial Consolida. As part of studying the biodiversity of norditerpenoid alkaloids (NDAS), the majority of which possess an N-ethyl group, we also quantified the fragment occurrence count in the SciFinder database for NDA skeletons. The wide range of NDA biodiversity is also captured in a review of over 100 recently reported isolated alkaloids. Ring A substitution at position 1 is important to determine the NDA skeleton conformation. In this overview of naturally occurring highly oxygenated NDAs from traditional Aconitum and Delphinium plants, consideration is given to functional effect and to real functional evidence. Their high potential biological activity makes them useful candidate molecules for further investigation as lead compounds in the development of selective drugs.

Tropes Revisited: Evert Sprinchorn'sIbsen's Kingdom: The Man and His Worksand Recent Historical Research in Ibsen Studies

Tropes Revisited: Evert Sprinchorn's<i>Ibsen's Kingdom: The Man and His Works</i>and Recent Historical Research in Ibsen Studies

Towards a Better Understanding of Genotype-Phenotype Correlations and Therapeutic Targets for Cardiocutaneous Genes: The Importance of Functional Studies above Prediction.

Genetic variants in gene-encoding proteins involved in cell–cell connecting structures, such as desmosomes and gap junctions, may cause a skin and/or cardiac phenotype, of which the combination is called cardiocutaneous syndrome. The cardiac phenotype is characterized by cardiomyopathy and/or arrhythmias, while the skin particularly displays phenotypes such as keratoderma, hair abnormalities and skin fragility. The reported variants associated with cardiocutaneous syndrome, in genes DSP, JUP, DSC2, KLHL24, GJA1, are classified by interpretation guidelines from the American College of Medical Genetics and Genomics. The genotype–phenotype correlation, however, remains poorly understood. By providing an overview of variants that are assessed for a functional protein pathology, we show that this number (n = 115) is low compared to the number of variants that are assessed by in silico algorithms (>5000). As expected, there is a mismatch between the prediction of variant pathogenicity and the prediction of the functional effect compared to the real functional evidence. Aiding to improve genotype–phenotype correlations, we separate variants into ‘protein reducing’ or ‘altered protein’ variants and provide general conclusions about the skin and heart phenotype involved. We conclude by stipulating that adequate prognoses can only be given, and targeted therapies can only be designed, upon full knowledge of the protein pathology through functional investigation.

The Effect of Social Media Marketing Towards Purchase Intentions in a Local Bakery: Khas Rotiselai

A local bakery SME in Bandung, West Java has optimized its social media presence to maintain its business performance for more than 8 years. However, so far, they don’t have any real evidence whether the implementation of their social media marketing is already effective in maintaining and improving their business performance especially in influencing its brand awareness and consumers’ purchase intention. This study aims to examine the relationship between social media marketing, brand awareness and purchase intention. The total number of respondents who fill the survey are 223 respondents. Then, the obtained data were analysed using PLS-SEM. The findings of the analysis show that Social Media Marketing’s Entertainment and Word of Mouth element significantly affects brand awareness, Social Media Marketing’s Customization and Interaction element have a significantly affects toward purchase intention, and results showed brand awareness is positively affecting Purchase Intention. This study also provides recommendations regarding social media marketing optimization that can be used for bakeries to improve its business performance, especially brand awareness and purchase intention.

EP08.02-010 Low-Dose Dacomitinib as First-Line Therapy for Driver-Positive Advanced Non-small Cell Lung Cancer: A Multicenter Real-World Study in China

In the ARCHER 1050 study, dacomitinib was shown to be more effective than gefitinib in patients with EGFR-mutant NSCLC, especially in patients with the EGFR exon 21L858R mutation. However, adverse events (AEs) were common with the 45 mg initial dose. Currently, real evidence of low-dose dacomitinib activity against the EGFR exon 21 L858R mutation is lacking.

Qualitative Analysis of Real Drug Evidence Using DART-MS and the Inverted Library Search Algorithm.

Chromatographic-less mass spectrometry techniques like direct analysis in real-time mass spectrometry (DART-MS) are steadily being employed as seized drug screening tools. However, these newer analytical platforms require new computational methods to best make use of the collected data. The inverted library search algorithm (ILSA) is a recently developed method designed specifically for working with mass spectra of mixtures collected with DART-MS and has been implemented as a function in the NIST/NIJ DART-MS data interpretation tool (DIT). This paper demonstrates how DART-MS and the ILSA/DIT can be used to analyze seized drug evidence, while discussing insights gathered during the evaluation of 92 adjudicated case samples. The evaluation verified that the combination of DART-MS and the ILSA/DIT can be used as an informative tool to help analysts screen seized drug evidence but also revealed several factors─such as the influence of incorporating multiple in-source fragmentation spectra and the effect of scoring thresholds─an analyst must consider while employing these methods. Use cases demonstrating the benefit of the nonscoring metrics provided by the ILSA/DIT and demonstrating how the ILSA/DIT can be used to identify novel substances are also presented. A summary of considerations for using the ILSA/DIT for drug screening concludes this paper.

Cacao agroforestry systems beyond the stigmas: Biotic and abiotic stress incidence impact.

Low technological knowledge in production chains, global climate change, and misinformation are concrete threats to food security. In addition, these combined threats also trigger ecological instability in megadiverse areas of the world, especially in some cacao-producing countries in South America, where this crop plays an important socio-economic role, even being used to replace illicit crops. Accordingly, the use of agroforestry systems approaches has emerged as a good alternative to maintain productivity, add high-value commodities to producers, and provide important ecosystem services for sustainable agriculture. However, limitations associated with the competition for resources between the species composing the system, and the higher incidence of some diseases, have led many producers to abandon this strategy, opting for monoculture. In this review, we seek to gather the main information available in the literature, aiming to answer the question: what is the real scientific evidence that supports the benefits and harms of adopting agroforestry systems in cacao production? We seek to make critical scrutiny of the possible negative effects of certain associations of the agroforestry system with biotic and abiotic stress in cacao. Here, we review the possible competition for light and nutrients and discuss the main characteristics to be sought in cacao genotypes to optimize these inter-specific relationships. In addition, we review the research advances that show the behavior of the main cacao diseases (Witch’s broom disease, frosty pod rot, black pod rot) in models of agroforestry systems contrasted with monoculture, as well as the optimization of agronomic practices to reduce some of these stresses. This compendium, therefore, sheds light on a major gap in establishing truly sustainable agriculture, which has been treated much more from the perspective of negative stigma than from the real technological advantages that can be combined to the benefit of a balanced ecosystem with generating income for farmers.

Briefly Noted

On July 6, 2021, the Third Section of the European Court of Human Rights issued its judgment in the above case concerning a trans woman's Article 8 right to family life and Article 14 right to non-discrimination on gender identity grounds. The Applicant (divorced) in the case was prevented from seeing her children by their biological mother on the grounds that her gender transition had caused irreparable harm to the mental health and morals of the children. During the dispute, an “expert report” had confirmed the Applicant's diagnosis of “transsexualism,” noting the applicant's “principled inability to preserve a male appearance” and her “insufficient consideration […] of the age-related specificities of the children's development,” and that report was relied upon by a district court in Moscow to prevent the Applicant from seeing her children. After several other unsuccessful appeals, the Applicant brought the case to the ECtHR, arguing under Article 8 that the restriction of her parental rights had not been necessary in a democratic society and was therefore a violation of her right to respect for family life. In reviewing the domestic courts' decisions, the Court criticized their reliance on the expert report, in particular its failure to actually explain how the Applicant's gender transition represented a risk to her children. According to the Court, this was even more concerning given that the report itself acknowledged that there is no real scientific evidence on this issue. Moreover, available international material “is unanimous that domestic courts deciding on the restriction of parental rights and contact should aim to (1) keep children together with their parents and, in the event of their separation, maintain direct contact between them on a regular basis, (2) take the child's best interests as a primary consideration, and (3) assess the entire family situation through close and individualised scrutiny.” The Court concluded that the domestic courts had failed to consider the Applicant's specific family situation and that a complete deprivation of parental rights should be reserved for only the most extreme circumstances, which were not present in this case. Therefore, the Court found a violation of Article 8.

Proyecto INCLIASMA - inercia clínica en asma

ObjectivesAsthma is a highly prevalent disease limiting the quality of life of patients and has high health costs. Despite having clinical practice guidelines, poor asthma control continues to be detected. The objective of this project is to study asthma management from primary care consultations in Aragón, Spain. Material and methodsQualitative, multicenter and non-randomized study, developed in two-round, following Delphi methodology. A group of a group of Primary Care physicians with extensive experience in asthma management were asked to express their level of agreement with the set of items of the questionnaire proposed by the scientific committee of the project. The 28-item survey was structured in 4 blocks: diagnosis, control, adherence and treatment. ResultsThe survey was answered by 15 experts. Consensus was reached in 82.14% (23/28) of the items. Difficulties were found in diagnosing asthma early and accurately. There is a confusion between control and severity. The perception of adherence is highly variable. There is an overuse of short-acting bronchodilators. Much therapeutic inertia is evidenced. ConclusionsThe INCLIASMA study highlights the existing controversies between what is advised in the guidelines of clinical practice and the real evidence and provides recommendations to correct the differences found.

Design of a Quarantine SITR Model Using the Novel Coronavirus Dynamics

This present study presents the mathematical dynamics of a new nonlinear quarantine SITR model based on the novel coronavirus (COVID-19). This study aims to investigate a mathematical model for coronavirus (COVID-19) and reveal its associated results. These studies collectively describe the social, psychological, interactive, behavioral, and mental health impacts of the novel coronavirus pandemic on people worldwide by using an efficient quarantine SITR model based on the most popular iterative scheme Runge-Kutta Method. The novelty of this attempt is that this model is defined as susceptible (S) class, infected (I) class, treatment (T)class, and recovered (R) class, i.e., quarantine SITR model. Furthermore, the class quarantine is also introducedin the model as the treatment subclass. The brief feature of each class is explained along with the explanation ofeach factor. In order to solve this new nonlinear quarantine SITR mathematical model, the famous Runge-Kuttanumerical scheme is applied. Moreover, some plots based on the new nonlinear quarantine SITR model usingdifferent parameter values indicate the existing details of this dangerous novel COVID-19. For example, the graphsof the susceptible people are decreasing, while those susceptible people who have some diseases or have old age aregetting higher up to dangerous levels. This real evidence indicates the exactness of the new nonlinear quarantineSITR model.

Implementasi Pembukuan Sederhana Dalam Upaya Peningkatan Produktivitas Kain Songket Tenun Medan

The impact of the COVID-19 pandemic has caused several Micro, Small and Medium Enterprises to decrease their production due to decreased demand from customers, one of which is our Service partner. Through this service, we hope that we can help our partners in overcoming production problems as well as in terms of bookkeeping. In this service activity the Service team has visited the Service partner to gather information regarding the main needs in the production process to sales, and the result is that the Service team donated equipment in the form of a high-speed sewing machine as much as 1 (one) unit to partners, the sewing machine can be used in production activities, previously in production our partners used the manual method, so with the help of this machine it is possible to increase the production capacity of partners. The method used in this service activity is a visit, on the first visit the Service team explores information related to business development and the obstacles or problems faced so far, then the Service team carries out service activities that answer the problems or constraints described by partners, the distribution of grants in the form of 1 unit of high speed sewing machine and assistance in simple bookkeeping procedures is a solution to the problems or obstacles experienced by partners so far. The Devotion Team hopes that partners will be better in running Micro, Small and Medium Enterprises. The real evidence from the work of 1 unit of high speed machine is the increase in production capacity to double before only being able to produce 10 units of production per day after the addition of a high speed sewing machine, production to 20 units per day and what's interesting is that our partners have implemented simple bookkeeping adequate and appropriate