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Integrating traditional Chinese (herbal) medicines into risk based regulation-with focus on non-clinical requirements to demonstrate safety

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Journal of Traditional Chinese Medical sciences 2020年第2期7卷 88-94页

作者： vivian s.w.Chan Fung Independent scholar 2 Woodward PlaceSt IvesNSW2075Australia

within the public health sector of Hong Kong(China),there is a consensus around the important role of traditional Chinese *** Hong Kong(China)to play a bridging role to bring Chinese medicines to the global market requires a concerted effort from the government,academic institutes and *** release of the final version of the European Medicines Agencies guidance document,which details the acceptance of minimum requirements to nonclinical package in bibliographical applications,grants the opportunity for well-established and traditional herbal medicines to demonstrate an‘acceptable safe’status for registration in the European *** is anticipated that this minimum nonclinical package can be applied to demonstrate the safe use of many traditional Chinese medicines regardless of their eligibility to be registered under the simplified procedure within the European *** paper conceptualizes an integration of a simplified evaluation route for eligible proprietary Chinese medicines(pCm)with long history of use into the existing drug regulatory framework in Hong Kong(China).such integration utilizing the minimum nonclinical package,based on bibliographical data or expert report,as proof of evidence to demonstrate safety for pCm with long history of use requires less demand in scientific *** Hong Kong(China)conducting‘first hand’review for eligible pCm,it provides an option for overseas and local pharmaceutical companies to register their products in Hong Kong(China)without the need to rely on issuance of Certificate of Pharmaceutical Product from other *** could bring eligible pCm with long history of use to reach international risk-based standard and to be marketed globally as‘medicines’to reach their full therapeutic *** important process to positioning Hong Kong(China)to compete with other countries in promoting importation and exportation of pCm to better serve the global health.

关键词： Proprietary and traditional Chinese herbal medicines Internationalization Nonclinical Drug regulation and registration reform Certificate of pharmaceutical product

RANKL inhibition reduces lesional cellularity and Gαs variant expression and enables osteogenic maturation in fibrous dysplasia

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Bone Research 2024年第1期12卷 165-179页

作者： Luis F.de Castro Jarred M.whitlock Zachary Michel Kristen Pan Jocelyn Taylor vivian szymczuk Brendan Boyce Daniel Martin Vardit Kram Rebeca Galisteo Kamran Melikov Leonid V.Chernomordik Michael T.Collins Alison M.Boyce skeletal Disorders and Mineral Homeostasis section National Institute of Dental and Craniofacial ResearchNational Institutes of HealthBethesdaMDUSA section on Membrane Biology Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentNational Institutes of HealthBethesdaMDUSA Metabolic Bone Disorders Unit National Institute of Dental and Craniofacial ResearchNational Institutes of HealthBethesdaMDUSA Department of Plastic and Reconstructive surgery The Johns Hopkins Medical InstitutionsBaltimoreMDUSA Department of Pathology and Laboratory Medicine University of Rochester Medical CenterRochesterNYUSA NIDCR Genomics and Computational Biology Core National Institute of Dental and Craniofacial ResearchNational Institutes of HealthBethesdaMDUSA

Fibrous dysplasia(FD)is a rare,disabling skeletal disease for which there are no established *** evidence supports inhibiting the osteoclastogenic factor receptor activator of nuclear kappa-B ligand(RANKL)as a potential treatment *** this study,we investigated the mechanisms underlying RANKL inhibition in FD tissue and its likely indirect effects on osteoprogenitors by evaluating human FD tissue pre-and post-treatment in a phase 2 clinical trial of denosumab(NCT03571191)and in murine in vivo and ex vivo preclinical *** analysis of human and mouse tissue demonstrated increased osteogenic maturation,reduced cellularity,and reduced expression of the pathogenic Gαs variant in FD lesions after RANKL *** sequencing of human and mouse tissue supported these *** interaction between osteoclasts and mutant osteoprogenitors.w.s further assessed in an ex vivo lesion model,which indicated that the proliferation of abnormal FD osteoprogenitors.w.s dependent on *** results from this study demonstrated that,in addition to its expected antiosteoclastic effect,denosumab reduces FD lesion activity by decreasing FD cell proliferation and increasing osteogenic maturation,leading to increased bone formation within *** findings highlight the unappreciated role of cellular crosstalk between osteoclasts and preosteoblasts/osteoblasts as a driver of FD pathology and demonstrate a novel mechanism of action of denosumab in the treatment of bone disease.

关键词： dysplasia treatment finding

Psychiatric sequelae of Chronic Pruritic Dermatoses

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Open Journal of Medical Psychology 2024年第2期13卷 25-38页

作者： Kelly Frasier vivian Li Kathleen Click Christina Dudzik Michelle sobotka Evadne Rodriguez Karina stech Nuvance Health/Vassar Brothers Medical Center Poughkeepsie NY USA school of Osteopathic Medicine Kansas City University Kansas City MO USA Touro College of Osteopathic Medicine Middleton Campus Middletown NY USA Abrazo Health Network Goodyear AZ USA school of Medicine University of Missouri-Columbia Columbia MO USA Lewis Katz school of Medicine at Temple University Philadelphia PA USA

This comprehensive review investigates the significant psychological impact and profound psychological comorbidities found in individuals suffering from chronic pruritic dermatoses, including atopic dermatitis, chronic urticaria, and prurigo nodularis. Highlighting the complex, reciprocal relationship between pruritus and psychiatric conditions such as depression, anxiety, and sleep disturbances, this paper elucidates the comprehensive impact of dermatological disorders on the skin in addition to the far-reaching effects on an individual’s psychological well-being. By evaluating the efficacy of integrated psychodermatological interventions, including cognitive behavioral therapy, mindfulness practices, pharmacological treatments, and innovative telepsychiatry and digital health solutions, this review aims to lay the foundation for a more holistic approach to treatment of concurrent dermatological and psychiatric conditions. Future research endeavors should delve deeper into the mechanistic foundation of the pruritus-psychiatry interface, the refinement of tailored treatment strategies, and the evaluation of long-term patient outcomes. In doing so, this review seeks to contribute to the optimization of patient care and well-being, underscoring the pivotal role of addressing both dermatological and psychological needs in achieving comprehensive health outcomes.

关键词： Psychodermatology Chronic Pruritic Dermatoses Psychological Comorbidities Integrated Interventions Pruritus-Psychiatry Interface

Application of Predictive Model for Efficient Cassava (Manihot esculenta Crantz) Yield in the Face of Climate Variability in Enugu state, Nigeria

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American Journal of Climate Change 2024年第2期13卷 361-389页

作者： Emeka Bright Ogbuene Tonia Nkiru Nwobodo Obianuju Gertrude Aloh Achoru Fred Emeka Josiah C. Ogbuka vivian Amarachi Ozorme Andrew M. Oroke Obiageli Jacinta Okolo Anwara Obianuju Amara E. s. Enemuo Centre for Environmental Management and Control (CEMAC) University of Nigeria Nsukka Nigeria Department of Geography University of Nigeria Nsukka Nigeria Department of Geography and Meteorology Enugu State University of Science and Technology (ESUT) Enugu Nigeria school of Civil Engineering Newcastle University Newcastle upon Tyne UK

Climate variability as occasioned by conditions such as extreme rainfall and temperature, rainfall cessation, and irregular temperatures has considerable impact on crop yield and food security. This study develops a predictive model for cassava yield (Manihot esculenta Crantz) amidst climate variability in rainfed zone of Enugu state, Nigeria. This study utilized data of climate variables and tonnage of cassava yield spanning from 1971 to 2012;as.w.ll as information from a questionnaire and focus group discussion from farmers across two seasons in 2023 respectively. Regression analysis.w.s employed to develop the predictive model equation for seasonal climate variability and cassava yield. The rainfall and temperature anomalies, decadal change in trend of cassava yield and opinion of farmers on changes in rainfall season were also computed in the study. The result shows the following relationship between cassava and all the climatic variables: R2 = 0.939;P = 0.00514;Cassava and key climatic variables: R2 = 0.560;P = 0.007. The result implies that seasonal rainfall, temperature, relative humidity, sunshine hours and radiation parameters are key climatic variables in cassava production. This is supported by computed rainfall and temperature anomalies.w.ich range from −478.5 to 517.8 mm as.w.ll as −1.2˚C to 2.3˚C over the years. The questionnaire and focus group identified that farmers experienced at one time or another, late onset of rain, early onset of rain or rainfall cessation over the years. The farmers are not particularly sure of rainfall and temperature characteristics at any point in time. The implication of the result of this study is that rainfall and temperature parameters determine the farming season and quantity of productivity. Hence, there is urgent need to address the situation through effective and quality weather forecasting network which will help stem food insecurity in the study area and Nigeria at large. The study made recommendations such as a

关键词： Climate Variability Cassava (Manihot esculenta Crantz) Predictive Model Yield

Application of Machine Learning for Flood Prediction and Evaluation in southern Nigeria

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Atmospheric and Climate sciences 2024年第3期14卷 299-316页

作者： Emeka Bright Ogbuene Chukwumeuche Ambrose Eze Obianuju Getrude Aloh Andrew Monday Oroke Damian Onuora Udegbunam Josiah Chukwuemeka Ogbuka Fred Emeka Achoru vivian Amarachi Ozorme Obianuju Anwara Ikechukwu Chukwunonyelum Anthonia Nneka Nebo Obiageli Jacinta Okolo Centre for Environmental Management and Control (CEMAC) University of Nigeria Enugu Nigeria Department of Geography Enugu State University of Science and Technology ESUT Enugu Nigeria school of Civil Engineering Newcastle University Newcastle upon Tyne UK

This study explored the application of machine learning techniques for flood prediction and analysis in southern Nigeria. Machine learning is an artificial intelligence technique that uses computer-based instructions to analyze and transform data into useful information to enable systems to make predictions. Traditional methods of flood prediction and analysis often fall short of providing accurate and timely information for effective disaster management. More so, numerical forecasting of flood disasters in the 19th century is not very accurate due to its inability to simplify complex atmospheric dynamics into simple equations. Here, we used Machine learning (ML) techniques including Random Forest (RF), Logistic Regression (LR), Naïve Bayes (NB), support Vector Machine (sVM), and Neural Networks (NN) to model the complex physical processes that cause floods. The dataset contains 59 cases.w.th the goal feature “Event-Type”, including 39 cases of floods and 20 cases of flood/rainstorms. Based on comparison of assessment metrics from models created using historical records, the result shows that NB performed better than all other techniques, followed by RF. The developed model can be used to predict the frequency of flood incidents. The majority of flood scenarios demonstrate that the event poses a significant risk to people’s lives. Therefore, each of the emergency response elements requires adequate knowledge of the flood incidences, continuous early warning service and accurate prediction model. This study can expand knowledge and research on flood predictive modeling in vulnerable areas to inform effective and sustainable contingency planning, policy, and management actions on flood disaster incidents, especially in other technologically underdeveloped settings.

关键词： Machine Learning Flood Prediction Evaluation southern Nigeria

Conjunctival flaps for the treatment of advanced ocular surface disease—looking back and beyond

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Annals of Eye science 2022年第4期7卷 40-49页

作者： Richard P.Gibralter vivian s.Hawn Department of Ophthalmology and Visual sciences Montefiore Medical CenterBronxNYUSA Albert Einstein College of Medicine BronxNYUSA John A.Moran Eye Center University of UtahSalt Lake CityUTUSA

Conjunctival flaps have previously proven to be effective in preserving the globe for individuals.w.th severe ocular surface *** keratitis,neurotrophic keratitis,nontraumatic corneal melts,descemetoceles,perforations,and corneal burns are all indications for this *** flaps promote nutrition,metabolism,structure,and vascularity,as.w.ll as reduce pain,irritation,inflammation,and ***,patients avoid the emotional and psychological repercussions of enucleation or evisceration,while requiring fewer postoperative medications and office ***,fewer flaps are performed due to the emergence of additional therapeutic techniques,such as serum tears,bandage lenses,corneal grafting,Oxervate,amniotic membrane,and umbilical cord ***,despite newer conservative medical methods,conjunctival flaps have been demonstrated to be useful and ***,future technologies and approaches for globe preservation and sight restoration after prior conjunctival flaps are ***,we review the history,advantages,and disadvantages of various surgical techniques:Gundersen’s bipedicle flap,partial limbal advancement flap,selective pedunculated conjunctival flap with or without Tenon’s capsule,and Mekonnen’s modified inferior palpebral-bulbar conjunctival *** surgical pearls and recommendations offered by the innovators are also reviewed,including restrictions and potential *** for visual rehabilitation in selective cases after conjunctival flap are reviewed as.w.ll.

关键词： Conjunctival flap Gunderson flap ocular surface reconstruction

Mitophagy:From the dark into the spotlight

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Molecular Plant 2023年第10期16卷 1487-1489页

作者： vivian schmitt Olivier Van Aken Department of Biology Lund UniversityLundSweden

Despite the generally placid appearance of plants,many dynamicprocesses take place inside a plant *** such process thathas garnered attention in recent years is termed"autophagy."while originally discovered in yeast,our understanding of autophagy in plants has improved *** is considered a cellular recycling system in which cellular components oreven entire organelles can be encapsulated by a membranestructure(autophagosome)and then transported to the vacuole(in plants)for degradation and re-use.

关键词： attention organelle spite

Resilience, the 6th Vital sign: Conceptualizing, Contextualizing, and Operationalizing All six Vital signs

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Health 2024年第7期16卷 657-673页

作者： Rose E. Constantino Betty J. Braxter Chi Ching vivian Hui Larissa C. Allen Lillian J. wolfe Katherine H. Endres Jezyl Cempron Cutamora Laurence L. Garcia Daisy R. Palompon Kathleen Thimsen Brayden N. Kameg Margarete L. Zalon Department of Health and Community systems School of Nursing University of Pittsburgh Pittsburgh PA USA Undergraduate Affairs School of Nursing University of Pittsburgh Pittsburgh PA USA The Hong Kong Polytechnic University Hong Kong China school of Nursing Adjunct Faculty at the University of Pittsburgh Pittsburgh PA USA school of Nursing University of Pittsburgh Pittsburgh PA USA Department of Health Promotion and Development School of Nursing University of Pittsburgh Pittsburgh PA USA College of Nursing Cebu Normal University Cebu City Philippines school of Nursing University of Nevada Las Vegas USA Department of Health and Community systems University of Pittsburgh PA USA Department of Nursing University of Scranton Scranton PA USA

There are five vital signs that healthcare providers assess: temperature, pulse, respiration, blood pressure, and pain. Normal levels for the five vital signs are published by the American Heart Association, and other specialty organizations, however, the sixth vital sign (resilience) which adopts the measure of immune resilience is suggested in this paper. Resilience is the ability of the immune system to respond to attacks and defend effectively against infections and inflammatory stressors, and psychological resilience is the capacity to resist, adapt, recover, thrive, and grow from a challenge or a stressor. Individuals.w.th better optimal immune resilience had better health outcomes than those with minimal immune resilience. The purpose of this paper is to conceptualize, contextualize, and operationalize all six vital signs. we suggest measuring resilience subjectively and objectively. subjectively, use a 5-item guided interview revised from the Connor-Davidson Resilience scale (CDRC), a scale of 10 items. The revised CDRC scale is a 5-item scale. The scale is rated on a 5-point Likert scale from 0 (not true) to 4 (true all the time). The total score ranges from 0 to 20, with higher total scores indicating greater resilience. The scale demonstrated good construct validity and internal consistency (α = 0.85) during the development of the scale. The CD-RIsC had a good Cronbach’s alpha level of 0.85. The Revised CD-RIsC can be completed in 2 - 4 minutes. To measure resilience objectively, we suggest using Immune Resilience (IR) levels, the level of resilience to preserve and/or rapidly restore immune resilience functions that promote disease resistance and control inflammation and other inflammatory stress. IR levels are gauged with two peripheral blood metrics that quantify the balance between CD8 and CD4 T-cell levels and gene expression signatures tracking longevity-associated immunocompetence and mortality- or entropy-associated inflammation. IR deregulation i

关键词： Conceptualization Contextualization Operationalization Body Temperature Pulse Respiration Blood Pressure Pain Resilience

A Data Mining Approach to Detecting Bias and Favoritism in Public Procurement

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Intelligent Automation & soft Computing 2023年第6期36卷 3501-3516页

作者： Yeferson Torres-Berru vivian F.Lopez-Batista Lorena Conde Zhingre University of salamanca Salamanca37008Spain Instituto Tecnológico superior sudamericano Loja1101608Ecuador Universidad Internacional del Ecuador Loja1101608Ecuador

In a public procurement process,corruption can occur at each stage,favoring a participant with a previous agreement,which can result in over-pricing and purchases of substandard products,as.w.ll as gender *** paper’s aim is to detect biased purchases using a spanish Language corpus,ana-lyzing text from the questions and answers registry platform by applicants in a public procurement process in ***,gender bias is detected,pro-moting both men and women to participate under the same *** order to detect gender bias and favoritism towards certain providers by contracting enti-ties,the study proposes a unique hybrid model that combines Artificial Intelli-gence algorithms and Natural Language Processing(NLP).In the experimental work,303,076 public procurement processes have been analyzed over 10 years(since 2010)with 1,009,739 questions and answers to suppliers and public insti-tutions in each *** bias and favoritism were analyzed using a word2-vec model with word embedding,as.w.ll as sentiment analysis of the questions and answers using the VADER *** 32%of cases(96,984 answers),there was favoritism or gender bias as evidenced by responses from contracting *** proposed model provides accuracy rates of 88% for detecting favor-itism,and 90%for detecting gender *** one-third of the procure-ment processes carried out by the state have indications of corruption and *** Latin America,government corruption is one of the most significant challenges,making the resulting classifier useful for detecting bias and favoritism in public procurement processes.

关键词： Favoritism bias natural language processing word2vec sentiment analysis word embeddings