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Scientific guidelines for preclinical research on potentised preparations manufactured according to current pharmacopoeias-the PrePoP guidelines

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Journal of Integrative Medicine 2024年第5期22卷 533-544页

作者： Alexander L.Tournier Leoni V.Bonamin Susann Buchheim-Schmidt steven Cartwright Christoph Dombrowsky Paul Doesburg Carla Holandino Maria Olga Kokornaczyk Everine Bvan de Kraats Jesús Antonio López-Carvallo Papiya nandy JoséManuel Mazón-Suástegui Fateme Mirzajani Bernard Poitevin Claudia Scherr Karin Thieves Sandra Würtenberger Stephan Baumgartner Institute of Complementary and Integrative Medicine University of Bern3010 BernBernSwitzerland Institute of Integrative Medicine Witten/Herdecke University58455 WittenNorth Rhine–WestphaliaGermany Homeopathy Research Institute London SW74EFUnited Kingdom Graduate Program on Environmental and Experimental Pathology Paulista UniversitySão Paulo 01504-000São PauloBrazil Department of Medical Science Deutsche Homöopathie-Union DHU-Arzneimittel GmbH&Co.KG76227 KarlsruheBaden-WürttembergGermany Cherwell Laboratory for Fundamental Research in Homeopathy Oxford OX28NUOxforeshireUnited Kingdom Society for Cancer Research Hiscia Research Institute4144 ArlesheimBaselSwitzerland Laboratório Multidisciplinar de Ciências Farmacêuticas Universidade Federal do Rio de JaneiroRio de Janeiro 21941-902Rio de JaneiroBrazil World Water Community Rotterdam 3029AKthe Netherlands Departamento de Acuicultura Facultad de Ciencias del MarUniversidad Católica del Norte1790437 CoquimboElquiChile Centre for Interdisciplinary Research and Education KolkataWest Bengal 700068West BengalIndia Laboratorio de Homeopatía Acuícola y Semillas Marinas Centro de Investigaciones Biológicas del NoroesteLa Paz 23096Baja California SurMexico Protein Research Center Shahid Beheshti UniversityTehran ***Iran Department of Medical Laboratory Science College of ScienceKnowledge University44001 ErbilErbilIraq SociétéSavante d’Homéopathie 75009 ParisFrance Sola Salus Institute for Homeopathic Research52511 GeilenkirchenNorth Rhine–WestphaliaGermany Scientific Society for Homeopathy 06366 KöthenSaxony-AnhaltGermany

Objective Pharmacopoeias regulate the manufacture of potentised pharmaceutical preparations used in different branches of complementary and integrative *** physicochemical properties and biological activity of these preparations are often investigated in preclinical research,yet no guidelines for experimental research currently exist in this *** present PrePoP guidelines aim to provide recommendations to promote high-quality,statistically sound,and reproducible preclinical research on potentised *** Input was gathered from researchers nominated by the relevant scientific societies using a simplified Delphi consensus approach covering the most relevant aspects of basic research methodology in the field including appropriate controls,sample preparation and handling,and *** three rounds of feedback,a consensus was finally reached on the most important aspects and considerations for conducting high-quality research on potentised *** We present a series of recommendations on a range of topics including experimental controls,system stability,blinding and randomisation,environmental influences,and procedures for the preparation of potentised samples and controls,and we address some specific challenges of this research *** This expert consensus process resulted in a robust set of methodological guidelines for research on potentised preparations and provides a valuable framework that will inform and improve the quality of subsequent research in this emerging field.

关键词： Research guidelines Fundamental research Basic research Complementary and integrative medicine Potentisation Potentised preparations

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Comparing outcomes from the two most recognized acupuncturist workforce surveys

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Journal of Integrative Medicine 2017年第1期15卷 37-43页

作者： steven H. Stumpf Kory ward-Cook Clifford R. Carr Health Administration Program California State University at NorthridgeNorthridgeCalifornia 91330USA national Certification Commission of Acupuncture and Oriental Medicine JacksonvilleFlorida 32202USA Clifford R.Carr 1743 PenmarAvenue#3VeniceCalifornia 90291USA

OBJECTIVE： To determine the informational consistency produced by the two most recent independent surveys and draw a conclusion whether the data would be sufficient for the national Center for Health Workforce Analysis and Bureau of Labor and Statistics consideration. METHODS： This paper compares workforce outcomes collected by the two most prominent acupuncture entities that have produced the most useful acupuncturist workforce data （California Acupuncture Board 2015 Occupational Analysis and the national Certification Commission of Acupuncture and Oriental Medicine^2013 Job Analysis） at national and state levels. RESULTS： Findings based upon the most compatible survey questions showed the following： more than 70% of acupuncturists work fewer than 40 hours weekly; approximately 76% work in solo practice or in shared space with other acupuncturists; more than 70% of the national sample have been in practice 15 years or less; and median income is between $40 000 and $50 000. A preponderance of acupuncturists is less than 50 years of age, and fewer than 15% of all respondents have been in practice more than 20 years. COnCLUSIOn： Basic workforce information is a necessary precursor for conducting workforce projections. It is useful to track the expansion or contraction of any given profession. Tracking influences subsequent planning for the profession based upon reliable and valid information about its growth. The ability of the profession to collect its own workforce data is paramount to workforce projection models. Any future survey should be a shared project that follows guidelines supported by the national Center for Health Workforce Analysis.

关键词： acupuncture workforce survey outcome assessment (health care) income

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A model for the control of DnA integrity by the sperm nuclear matrix

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Asian Journal of Andrology 2015年第4期17卷 610-615页

作者： Joanna E Gawecka Jordi Ribas-Maynou Jordi Benet W steven ward Clinical and Translational Research Program Universityof Hawaii Cancer Center Honolulu HI USA Cell BiologyUnit Cell Biology Phisiology and Immunology DepartmentMedicine Faculty Universitat Autonoma de Barcelona08193 Bellaterra Spain Center of Male Infertility andAnalysis de Barcelona Edifici Eureka PBM5 Parc deRecerca de la UAB Campus de la UAB 08193 BellaterraSpain Institute for Biogenesis Research Departmentof Anatomy Biochemistry and Physiology Honolulu HIUSA Department of Obstetrics Gynecology and Women'sHealth John A. Burns School of Medicine University ofHawaii at Manoa. Honolulu. HI 96822. USA.

The highly condensed chromatin of mammalian spermatozoa is usually considered to be biologically inert before fertilization. However, we have demonstrated that even in this compacted state, sperm chromatin is subject to degradation at open configurations associated with the nuclear matrix through a process we have termed sperm chromatin fragmentation （SCF）. ＂[his suggests that a mechanism exists to monitor the health of spermatozoa during transit through the male reproductive tract and to destroy the genome of defective sperm cells. The site of DnA damage in SCF, the matrix attachment sites, are the same that we hypothesize initiate DnA synthesis in the zygote. When sperm that have damaged DnA are injected into the oocyte, the newly created zygote responds by delaying DnA synthesis in the male pronudeus and, if the damage is severe enough, arresting the embryo＇s development. Here we present a model for paternal DnA regulation by the nuclear matrix that begins during sperm maturation and continues through early embryonic development.

关键词： DnA mammalian spermatozoa

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Pum 1 sequesters apoptosis during spermatogenesis

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Asian Journal of Andrology 2012年第4期14卷 513-513页

作者： W steven ward Department of Anatomy Biochemistry and Physiology Institute for Biogenesis Research John A. Burns School of Medicine Universityof Hawaii at Manoa Honolulu HI 96822 USA

RnA binding proteins have long been known to play a role in spermatogenesis. The laboratory of norman Hecht was one of the leaders in this field, having characterized three RnA binding proteins that regulate mRnAs during sperm differentiation. Polypyrimidine tract-binding pro- tein 2 （PTB2） has two functions--stabilizing mRnA transcripts in the cytoplasm and being involved in splicing,l Using in vivo cross- linking of protein to RnA, several mRnA and small RnA targets were identified in the testis.2 Translin is another protein that both stabilizes mRnAs from a specific transcription factor, and is associated with small RnAs.3 Perhaps the most interesting is the DnA/RnA binding protein MSY2. At low concentrations,

关键词： MALE GERM-CELLS BInDInG PROTEIn RnA MSY2

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Stem Cell Ophthalmology Treatment Study (SCOTS)： bone marrow-derived stem cells in the treatment of Leber＇s hereditary optic neuropathy

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neural Regeneration Research 2016年第10期11卷 1685-1694页

作者： Jeffrey n. Weiss steven Levy Susan C. Benes Retina Associates of South Florida 5800 Colonial Drive Suite 300 Margate FL USA MD Stem Cells 3 Sylvan Road South Westport CT USA The Eye Center of Columbus The Ohio State University Columbus OH USA

The Stem Cell Ophthalmology Treatment Study （SCOTS） is currently the largest-scale stem cell ophthal- mology trial registered at *** （identifier： nCT01920867）. SCOTS utilizes autologous bone marrow-derived stem cells （BMSCs） to treat optic nerve and retinal diseases. Treatment approaches include a combination of retrobulbar, subtenon, intravitreal, intra-optic nerve, subretinal, and intravenous injection of autologous BMSCs according to the nature of the disease, the degree of visual loss, and any risk factors related to the treatments. Patients with Leber＇s hereditary optic neuropathy had visual acuity gains on the Early Treatment Diabetic Retinopathy Study （ETDRS） of up to 35 letters and Snellen acuity improvements from hand motion to 20/200 and from counting fingers to 20/100. Visual field improvements were noted. Macular and optic nerve head nerve fiber layer typically thickened. no serious complications were seen. The increases in visual acuity obtained in our study were encouraging and suggest that the use of autolo- gous BMSCs as provided in SCOTS for ophthalmologic mitochondrial diseases including Leber＇s hereditary optic neuropathy may be a viable treatment option.

关键词： nerve regeneration Leber's hereditary optic neuropathy mitochondrial disease optic neuropathy bone marrow derived stem cells blindness visual loss neural regeneration

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Stem Cell Ophthalmology Treatment Study(SCOTS) for retinal and optic nerve diseases: a case report of improvement in relapsing auto-immune optic neuropathy

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neural Regeneration Research 2015年第6期10卷 1507-1515页

作者： Jeffrey n.Weiss steven Levy Susan C.Benes Retina Associates of South Florida MD Stem Cells Wilmer Eye Institute The Johns Hopkins Hospital

We present the results from a patient with relapsing optic neuropathy treated within the Stem Cell Ophthalmology Treatment Study （SCOTS）. SCOTS is an Institutional Review Board ap- proved clinical trial and has become the largest ophthalmology stem cell study registered at the national Institutes of Health to date （*** Identifier nCT 01920867）. SCOTS utilizes autologous bone marrow-derived stem cells （BMSCs） for treatment of retinal and optic nerve diseases. Pre-treatment and post-treatment comprehensive eye exams of a 54 year old female patient were performed both at the Florida Study Center, USA and at The Eye Center of Columbus, USA. As a consequence of a relapsing optic neuritis, the patient＇s previously normal visual acuity decreased to between 20/350 and 20/400 in the right eye and to 20/70 in the left eye. Significant visual field loss developed bilaterally. The patient underwent a right eye vitrectomy with injection of BMSCs into the optic nerve of the right eyeand retrobulbar, subtenon and in- travitreal injection of BMSCs in the left eye. At 15 months after SCOTS treatment, the patient＇s visual acuity had improved to 20/150 in the right eye and 20/20 in the left eye. Bilateral visual fields improved markedly. Both macular thickness and fast retinal nerve fiber layer thickness were maximally improved at 3 and 6 months after SCOTS treatment. The patient also reduced her mycophenylate dose from 1,500 mg per day to 500 mg per day and required no steroid pulse therapy during the 15-month follow up.

关键词： nerve regeneration stem cells optic nerve autoimmune optic neuropathy ophthalmology bone marrow-derived stem cells blindness visual loss Stem Cell Ophthalmology Treatment Study neural regeneration

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Development,validation,and transportability of several machine-learned,non-exercise-based VO_(2max)prediction models for older adults

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Journal of Sport and Health Science 2024年第5期13卷 611-620页

作者： Benjamin T.Schumacher Michael J.LaMonte Andrea Z.LaCroix Eleanor M.Simonsick steven P.Hooker Humberto Parada Jr. John Bellettiere Arun Kumar Herbert Wertheim School of Public Health and Human Longevity Science University of California San DiegoLa JollaCA 92093USA Department of Epidemiology and Environmental Health School of Public Health and Health ProfessionsUniversity at BuffaloState University of New YorkBuffaloNY 14214USA Translational Gerontology Branch Intramural Research ProgramNational Institute on AgingNational Institutes of HealthBaltimoreMD 21225USA College of Health and Human Services San Diego State UniversitySan DiegoCA 92182USA Division of Epidemiology and Biostatistics School of Public HealthSan Diego State UniversitySan DiegoCA 92182USA University of California San Diego Moores Cancer Center La JollaCA 92093USA Computer Science and Engineering and Halicioglu Data Science Institute University of California San DiegoLa JollaCA 92093USA

Background:There exist few maximal oxygen uptake(VO_(2max))non-exercise-based prediction equations,fewer using machine learning(ML),and none specifically for older *** direct measurement of VO_(2max)is infeasible in large epidemiologic cohort studies,we sought to develop,validate,compare,and assess the transportability of several ML VO_(2max)prediction ***:The Baltimore Longitudinal Study of Aging(BLSA)participants with valid VO2_(max)tests were included(n=1080).Least absolute shrinkage and selection operator,linear-and tree-boosted extreme gradient boosting,random forest,and support vector machine(SVM)algorithms were trained to predict VO_(2max)*** developed these algorithms for:(a)the overall BLSA,(b)by sex,(c)using all BLSA variables,and(d)variables common in aging ***,we quantified the associations between measured and predicted VO_(2max)and ***:The age was 69.0±10.4 years(mean±SD)and the measured VO_(2max)was 21.6±5.9 mL/kg/*** absolute shrinkage and selection operator,linear-and tree-boosted extreme gradient boosting,random forest,and support vector machine yielded root mean squared errors of 3.4 mL/kg/min,3.6 mL/kg/min,3.4 mL/kg/min,3.6 mL/kg/min,and 3.5 mL/kg/min,*** quartiles of measured VO_(2max)showed an inverse gradient in mortality *** VO_(2max)variables yielded similar effect estimates but were not robust to ***:Measured VO_(2max)is a strong predictor of *** ML can improve the accuracy of prediction as compared to simpler approaches but estimates of association with mortality remain sensitive to *** studies should seek to reproduce these results so that VO_(2max),an important vital sign,can be more broadly studied as a modifiable target for promoting functional resiliency and healthy aging.

关键词： Cardiorespiratory fitness Prediction algorithms Epidemiology Mortality

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Stem Cell Ophthalmology Treatment Study (SCOTS)： improvement in serpiginous choroidopathy following autologous bone marrow derived stem cell treatment

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neural Regeneration Research 2016年第9期11卷 1512-1516页

作者： Jeffrey n. Weiss Susan C. Benes steven Levy Retina Associates of South Florida 5800 Colonial Drive Suite 300 Margate FL USA The Eye Center of Columbus The Ohio State University Columbus OH USA MD Stem Cells 3 Sylvan Road South Westport CT USA

We report results in a 77-year-old male patient with visual loss from long-standing serpiginous choroidop- athy treated with bone marrow derived stem cells （BMSC） within the Stem Cell Ophthalmology Treatment Study （SCOTS）. SCOTS is an Institutional Review Board approved clinical trial and the largest ophthal- mology stem cell study registered at the national Institutes of Health to date （*** Identifier： nCT01920867）. Eight months after treatment by a combination of retrobulbar, subtenon, intravitreal and intravenous injection of BMSC, the patient＇s best corrected Snellen acuity improved from 20/80- to 20/60.1 in the right eye and from 20/50- to 20/20 3 in the left eye. The Early Treatment of Diabetic Retinopathy Study （ETDRS） visual acuity continued to improve over the succeeding 8 months and the optical coherence tomography macular volume increased. The increases in visual acuity and macular volume are encouraging and suggest that the use of BMSC as provided in SCOTS may be a viable approach to treating serpiginous choroidopathy.

关键词： serpiginous choroidopathy serpigionous choroiditis geographic helicoid peripapillary chroidopathy retina macula stem cell therapy uveitis

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A new Speedy/RInGO protein may help regulate male meiosis

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Asian Journal of Andrology 2011年第3期13卷 363-363页

作者： Yukiko Yamazaki W steven ward Institute for Biogenesis Research University of Hawaii at Manoa Honolulu HI 96822 USA

Reproductive biology, although seen as a specialty study area, has many unique biology models that offer insight into the regulation of cellular processes that are shared by many different cell types. The most celebra... 详细信息

关键词： Biology Regulations Cell cycle Testes Meiosis Proteins Protein products Lates Cells Lymphocytes

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Dynamic Patterns of Gene Expression Additivity and Regulatory Variation throughout Maize Development

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Molecular Plant 2019年第3期12卷 410-425页

作者： Peng Zhou Candice n.Hirsch steven P.Briggs nathan M.Springer Department of Plant and Microbial Biology University of MinnesotaSaint PaulMN 55108USA Department of Agronomy and Plant Genetics University of MinnesotaSaint PaulMN 55108USA Division of Biological Sciences University of CaliforniaSanDiegoLaJollaCA92093USA

Gene expression variation is a key component underlying phenotypic variation and heterosis. Transcriptome profiling was performed on 23 different tissues or developmental stages of two maize inbreds, B73 and Mo17, as well as their hybrid. The obtained large-scale datasets provided opportunities to monitor the developmental dynamics of differential expression, additivity for gene expression, and regulatory variation. The transcriptome can be divided into .30 000 genes that are expressed in at least one tissue of one in bred and an additional ~10 000 “silent” genes that are not expressed in any tissue of any genotype, 90% of which are non-syntenic relative to other grasses. Many (.74%) of the expressed genes exhibit differential expression in at least one tissue. However, the majority of genes with differential expression do not exhibit consistent differential expression in different tissues. These genes often exhibit tissue-specific differential expression with equivalent expression in other tissues, and in many cases they switch the directionality of differential expression in different tissues. This suggests widespread variation for tissue-specific regulation of gene expression between the two maize inbreds B73 and Mo17. nearly 5000 genes are expressed in only one parent in at least one tissue (single parent expression) and 97% of these genes are expressed at mid-parent levels or higher in the hybrid, providing extensive opportunities for hybrid complementation in heterosis. In general, additive expression patterns are much more common than non-additive patterns, and this trend is more pronounced for genes with strong differential expression or single pare nt expressi on. There is relatively little evidence for non-additive expression patterns that are maintained in multiple tissues. The analysis of allele-specific expression allowed classification of cis. and trans-regulatory variation. Genes with c/s-regulatory variation often exhibit additive expression and tend

关键词： maize gene expression heterosis differential expression non-additive expression allele-specific expression

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