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Citizen science’s transformative impact on science, citizen empowerment and socio-political processes

Socio-Ecological Practice research 2023年第1期5卷 11-33页

作者： von Gönner, Julia Herrmann, Thora M. Bruckermann, Till Eichinger, Michael Hecker, Susanne Klan, Friederike Lorke, Julia richter, Anett Sturm, Ulrike Voigt-Heucke, Silke Brink, Wiebke Liedtke, Christin Premke-Kraus, Matthias Altmann, Carolin Bauhus, Wilhelm Bengtsson, Luiza Büermann, Andrea dietrich, Peter dörler, daniel Eich-Brod, regina Ferschinger, Laura Freyberg, Linda Grützner, Agnes Hammel, Gertrud Heigl, Florian Heyen, Nils B. Hölker, Franz Johannsen, Carolin Kluß, Thorsten Kluttig, Thekla Knobloch, Jörn Munke, Martin Mortega, Kim Pathe, Carsten Soßdorf, Anna Stämpfli, Tiina Thiel, Christian Tönsmann, Susanne Valentin, Anke Wagenknecht, Katherin Wegener, robert Woll, Silvia Bonn, Aletta Department of Ecosystem Services Helmholtz Centre for Environmental Research - UFZ Permoserstr. 15 Leipzig 04318 Germany Institute of Biodiversity Friedrich Schiller University Jena Dornburgerstr. 159 Jena 07743 Germany German Centre for Integrative Biodiversity Research (iDiv) Halle-Jena-Leipzig Puschstr. 4 Leipzig 04103 Germany Institute of Education Leibniz University Hannover Schloßwenderstr. 1 Hannover 30159 Germany Center for Preventive Medicine and Digital Health Medical Faculty Mannheim Heidelberg University Ludolf-Krehl-Str. 7-11 Mannheim 68167 Germany Institute of Medical Biostatistics Epidemiology and Informatics University Medical Center of the Johannes Gutenberg University Mainz Obere Zahlbacher Str. 69 Mainz 55131 Germany Leibniz Institute for Evolution and Biodiversity Science Museum Für Naturkunde Berlin Invalidenstr. 43 Berlin 10115 Germany Institute of Data Science German Aerospace Center (DLR) Mälzerstr. 3-5 Jena 07745 Germany Leibniz Institute for Science and Mathematics Education Olshausenstr. 62 Kiel 24118 Germany Thünen-Institute of Biodiversity Bundesallee 65 Brunswick 38116 Germany Wissenschaft Im Dialog Charlottenstr. 80 Berlin 10117 Germany Helmholtz Association Berlin Head Office Anna-Louisa-Karsch-Str. 2 Berlin 10178 Germany Leibniz Association Berlin Head Office Chausseestr.111 Berlin 10115 Germany Research Transfer Office University of Münster Robert-Koch-Str.40 Münster 48149 Germany Max-Delbrück-Center for Molecular Medicine in the Helmholtz Association Robert-Rössle-Str.10 Berlin 13125 Germany Department of Monitoring and Exploration Technologies Helmholtz Centre for Environmental Research - UFZ Permoserstr. 15 Leipzig 04318 Germany Institute of Zoology University of Natural Resources and Life Sciences Vienna Gregor-Mendel-Str. 33 Vienna 1180 Austria Institute for Energy and Climate Research IEK8 Forschungszentrum Jülich GmbH Jülich 52425 Germany Heinrich Heine University Duesseldorf Universitä

Citizen science (CS) can foster transformative impact for science, citizen empowerment and socio-political processes. To unleash this impact, a clearer understanding of its current status and challenges for its development is needed. Using quantitative indicators developed in a collaborative stakeholder process, our study provides a comprehensive overview of the current status of CS in Germany, Austria and Switzerland. Our online survey with 340 responses focused on CS impact through (1) scientific practices, (2) participant learning and empowerment, and (3) socio-political processes. With regard to scientific impact, we found that data quality control is an established component of CS practice, while publication of CS data and results has not yet been achieved by all project coordinators (55%). Key benefits for citizen scientists were the experience of collective impact (“making a difference together with others”) as well as gaining new knowledge. For the citizen scientists’ learning outcomes, different forms of social learning, such as systematic feedback or personal mentoring, were essential. While the majority of respondents attributed an important value to CS for decision-making, only few were confident that CS data were indeed utilized as evidence by decision-makers. Based on these results, we recommend (1) that project coordinators and researchers strengthen scientific impact by fostering data management and publications, (2) that project coordinators and citizen scientists enhance participant impact by promoting social learning opportunities and (3) that project initiators and CS networks foster socio-political impact through early engagement with decision-makers and alignment with ongoing policy processes. In this way, CS can evolve its transformative impact. © 2023, The Author(s).

关键词： data quality Participatory research Political uptake recognition research data management Social learning

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Correction to: development and Content Validation of Pruritus and Symptoms Assessment for Atopic dermatitis (PSAAd) in Adolescents and Adults with Moderate-to-Severe Ad

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dermatology and therapy 2021年第4期11卷 1449-1450页

作者： rebecca Hall Mark G Lebwohl Andrew G Bushmakin Eric L Simpson Melinda J Gooderham Andreas Wollenberg Adam Gater Jane r Wells Joseph C Cappelleri Ming-Ann Hsu Jocelyn Papacharalambous Elena Peeva Anna M Tallman Weidong Zhang Linda Chen Patient-Centered Outcomes Adelphi Values Adelphi Mill Bollington Cheshire UK. rebecca.hall@***. Kimberly and Eric J. Waldman Department of Dermatology Icahn School of Medicine at Mount Sinai New York NY USA. PIH Statistics Pfizer Inc. Groton CT USA. Department of Dermatology Oregon Health and Science University Portland OR USA. SKiN Centre for Dermatology and Probity Medical Research Peterborough ON Canada. Queen's University Kingston ON Canada. Department of Dermatology and Allergy Ludwig-Maximilians-Universität München Munich Germany. Patient-Centered Outcomes Adelphi Values Adelphi Mill Bollington Cheshire UK. Global Biometrics and Data Management Pfizer Inc. Groton CT USA. PIH-Global Health and Value Pfizer Inc. Groton CT USA. Pfizer Inc. New York NY USA. R&D-Inflammation and Immunology Pfizer Inc. Cambridge MA USA. Pfizer Inc. Cambridge MA USA.

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LBA82 Efficacy and safety of ponsegromab, a first-in-class, monoclonal antibody inhibitor of growth differentiation factor 15, in patients with cancer cachexia: A randomized, placebo-controlled, phase II study

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Annals of Oncology 2024年 35卷 S1269-S1269页

作者： J. Crawford J.d. Groarke S.M. Collins S. Lubaczewski E.J. roeland T. Naito A.E. Hendifar M.T. Fallon K. Takayama T.r. Asmis r.F. dunne M. rossulek r. Qiu A.r. Saxena Duke Cancer Institute Duke University Medical Center Durham NC USA Internal Medicine Research Unit Pfizer Inc Cambridge MA USA Global Biometrics and Data Management Pfizer R&D UK Ltd Kent UK Translational Clinical Sciences Pfizer Inc Collegeville PA USA Knight Cancer Institute Oregon Health and Science University Portland OR USA Cancer Supportive Care Center Shizuoka Cancer Center Shizuoka Japan Samuel Oschin Cancer Center Cedars-Sinai Medical Center Los Angeles CA USA Edinburgh Cancer Research Centre Institute of Genetics and Cancer University of Edinburgh Edinburgh UK Department of Pulmonary Medicine Kyoto Prefectural University of Medicine Kyoto Japan Medical Oncology Department The Ottawa Hospital Cancer Centre Ottawa ON Canada Wilmot Cancer Institute University of Rochester Medical Center Rochester NY USA Internal Medicine Research Unit Pfizer Inc Tampa FL USA Clinical Pharmacology Pfizer Inc Cambridge MA USA

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USING FOrUM ANd SEArCH data FOr SALES PrEdICTION OF HIGH-INVOLVEMENT PrOJECTS

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MIS QUArTErLY 2017年第1期41卷 65-+页

作者： Geva, Tomer Oestreicher-Singer, Gal Efron, Niv Shimshoni, Yair Tel Aviv Univ Coller Sch Management POB 39040 IL-6997801 Tel Aviv Israel Google Search & Big Data Anal Technol Tel Aviv Israel Google R&D Ctr Tel Aviv Israel

A large body of research uses data from social media websites to predict offline economic outcomes such as sales. However, recent research also points out that such data may be subject to various limitations and biases that may hurt predictive accuracy. At the same time, a growing body of research shows that a new source of online information, search engine logs, has the potential to predict offline outcomes. We study the relationship between these two important data sources in the context of sales predictions. Focusing on the automotive industry, a classic example of a domain of high-involvement products, we use Google's comprehensive index of Internet discussion forums, in addition to Google search trend data. We find that adding search trend data to models based on the more commonly used social media data significantly improves predictive accuracy. We also find that predictive models based on inexpensive search trend data provide predictive accuracy that is comparable, at least, to that of social media data-based predictive models. Last, we show that the improvement in accuracy is considerably larger for "value" car brands, while for "premium" car brands the improvement obtained is more moderate.

关键词： Search trends forums social media word-of-mouth consumers' interest sales prediction online data high involvement products

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Early detection of vessel delays using combined historical and real-time information

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JOUrNAL OF THE OPErATIONAL rESEArCH SOCIETY 2017年第2期68卷 182-191页

作者： Kim, Sungil Kim, Heeyoung Park, Yongro UNIST Sch Management Engn Ulsan South Korea Korea Adv Inst Sci & Technol Dept Ind & Syst Engn Daejeon South Korea Samsung SDS Data Analyt Lab R&D Ctr Seoul South Korea

In ocean transportation, detecting vessel delays in advance or in real time is important for fourth-party logistics (4PL) in order to fulfill the expectations of customers and to help customers reduce delay costs. However, the early detection of vessel delays faces the challenges of numerous uncertainties, including weather conditions, port congestion, booking issues, and route selection. recently, 4PLs have adopted advanced tracking technologies such as satellite-based automatic identification systems (S-AISs) that produce a vast amount of real-time vessel tracking information, thus providing new opportunities to enhance the early detection of vessel delays. This paper proposes a data-driven method for the early detection of vessel delays: in our new framework of refined case-based reasoning (CBr), real-time S-AIS vessel tracking data are utilized in combination with historical shipping data. The proposed method also provides a process of analyzing the causes of delays by matching the tracking patterns of real-time shipments with those of historical shipping data. real data examples from a logistics company demonstrate the effectiveness of the proposed method.

关键词： big data predictive analytics case-based reasoning data stream delay detection real-time analytics

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Long-term effect of galantamine on cognitive function in patients with Alzheimer's disease versus a simulated disease trajectory: an observational study in the clinical setting

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NEUrOPSYCHIATrIC dISEASE ANd TrEATMENT 2017年 13卷 1115-1124页

作者： Nakagawa, ryoko Ohnishi, Takashi Kobayashi, Hisanori Yamaoka, Toshio Yajima, Tsutomu Tanimura, Ai Kato, Toshiya Yoshizawa, Kazutake Janssen Pharmaceut KK Evidence Generat Dept Med Affairs Div Tokyo Japan Janssen Pharmaceut KK Clin Data Management Dept R&D Div Tokyo Japan Janssen Pharmaceut KK Biostat Dept Quantitat Sci Div Tokyo Japan Janssen Pharmaceut KK Drug Surveillance Dept R&D Div Tokyo Japan

Background: Long-term maintenance of cognitive function is an important goal of treatment for Alzheimer's disease (Ad), but evidence about the long-term efficacy of cholinesterase inhibitors is sparse. To evaluate the long-term efficacy and safety of galantamine for Ad in routine clinical practice, we conducted a 72-week post-marketing surveillance study. The effect of galantamine on cognitive function was estimated in comparison with a simulated disease trajectory. Patients and methods: Patients with mild-to-moderate Ad received flexible dosing of galantamine (16-24 mg/day) during this study. Cognitive function was assessed by the mini mental state examination (MMSE) and the clinical status was determined by the Clinical Global Impression-Improvement (CGI-I). Changes of the MMSE score without treatment were estimated in each patient using Mendiondo's model. Generalized linear mixed model analysis was performed to compare the simulated MMSE scores with the actual scores. results: Of the 661 patients who were enrolled, 642 were evaluable for safety and 554 were assessed for efficacy. The discontinuation rate was 46.73%. Cognitive decline indicated by the mean change of actual MMSE scores was significantly smaller than the simulated decline. Individual analysis demonstrated that >70% of patients had better actual MMSE scores than their simulated scores. Significant improvement of CGI-I was also observed during the observation period. Adverse events occurred in 28.5% of patients and were serious in 8.41%. The reported events generally corresponded with the safety profile of galantamine in previous studies. Conclusion: These findings support the long-term efficacy of galantamine for maintaining cognitive function and the clinical state in Ad patients. Treatment with galantamine was generally safe. Importantly, this study revealed that galantamine improved cognitive function above the predicted level in >70% of the patients.

关键词： Alzheimer's disease cholinesterase inhibitor cognitive function disease progression real-world evidence

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In Vitro dissolution Profiles Similarity Assessment in Support of drug Product Quality: What, How, When-Workshop Summary report

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AAPS JOUrNAL 2020年第4期22卷 74-74页

作者： Suarez-Sharp, Sandra Abend, Andreas Hoffelder, Thomas Leblond, david delvadia, Poonam Kovacs, Elisabeth diaz, dorys Argelia US FDA Div Biopharmaceut Off New Drug Prod Off Pharmaceut QualCtr Drug Evaluat & Res Silver Spring MD 20993 USA Simulat Plus Inc Regulatory Affairs 42505 10th St West Lancaster CA 93534 USA Merck & Co Inc Pharmaceut Sci 770 Sumneytown Pike West Point PA 19486 USA Boehringer Ingelheim Pharma GmbH & Co KG Global Biostat & Data Sci Binger Str 173 D-55216 Ingelheim Germany CMC Stat Studies 3091 Midlane Dr Wadsworth IL 60083 USA EK Consulting Analyt R&D Prod Dev & Life Cycle Management Biopharmaceut 6 Reditt Crt Richmond Hill ON LAC 7S4 Canada Pfizer Inc Global Prod Dev Eastern Point Rd Groton CT 06340 USA

The pharmaceutical industry and regulatory agencies rely on dissolution similarity testing to make critical product performance decisions as part of drug product life cycle management. Accordingly, the application of mathematical approaches to evaluate dissolution profile similarity is described in regulatory guidance. However, the requirements (e.g., which time points, number of time points, %CV) to apply the widely known similarity factor f(2) and other alternative statistical approaches diverge noticeably across regulatory agencies. In an effort to highlight current practices to assess dissolution profile similarity and to strive towards global harmonization, a workshop entitled "in vitro dissolution similarity assessment in support of drug product quality: what, how, when" was held May 21-22, 2019, at the University of Maryland, Baltimore. This article summarizes key points from the podium presentations and breakout (BO) sessions focusing on (1) contrasting the advantages and disadvantages of several statistical methods;(2) the importance of experimental design for successful similarity evaluation;(3) the value of similarity evaluation in light of clinically relevant specifications;and (4) the need for creating a robust and scientifically appropriate path (e.g., non-prescriptive decision tree) for dissolution profile similarity assessment as a stepping stone for global harmonization.

关键词： In vitro dissolution dissnolutio similarity testing safe space decision tree

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Trastuzumab deruxtecan (T-dXd) in patients with HEr2-positive metastatic breast cancer (MBC): Updated survival results from a phase II trial (dESTINY-Breast01)

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ANNALS OF ONCOLOGY 2021年 32卷 S485-S486页

作者： Saura Manich, C. Modi, S. Krop, I. Park, Y. H. Kim, S-B. Tamura, K. Andre, F. Iwata, H. Ito, Y. Tsurutani, J. Sohn, J. Lee, C. Liu, Y. Cathcart, J. Singh, J. Yamashita, T. Vall dHebron Univ Hosp Vall dHebron Inst Oncol VHIO Med Oncol Barcelona Spain Mem Sloan Kettering Canc Ctr Med New York NY USA Dana Farber Canc Inst Med Oncol Boston MA USA Samsung Med Ctr Med Seoul South Korea Asan Med Ctr Oncol Seoul South Korea Shimane Univ Hosp Med Oncol Izumo Shimane Japan Gustave Roussy Med Oncol Villejuif France Aichi Canc Ctr Hosp Breast Oncol Nagoya Aichi Japan Canc Inst Hosp JFCR Breast Surg Oncol Tokyo Japan Showa Univ Advanced Canc Translat Res Inst Tokyo Japan Yonsei Canc Ctr Internal Med Seoul South Korea Global Oncol R&D Daiichi Sankyo Basking Ridge NJ USA Biostatist & Data Management Daiichi Sankyo Basking Ridge NJ USA Clin Dev Daiichi Sankyo Basking Ridge NJ USA Clin Safety & Pharmacovigilance Basking Ridge NJ USA Kanagawa Canc Ctr Breast & Endocrine Surg Yokohama Kanagawa Japan

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A randomized, double-blind study of hydromorphone hydrochloride extended-release tablets versus oxycodone hydrochloride extended-release tablets for cancer pain: efficacy and safety in Japanese cancer patients (EXHEAL: a Phase III study of EXtended-release HydromorphonE for cAncer pain reLief)

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JOUrNAL OF PAIN rESEArCH 2017年 10卷 1953-1961页

作者： Inoue, Satoshi Saito, Yoji Tsuneto, Satoru Aruga, Etsuko Ide, Azusa Kakurai, Yasuyuki Daiichi Sankyo R&D Div Clin Dev Dept Tokyo Japan Shimane Univ Fac Med Dept Anesthesiol Matsue Shimane Japan Kyoto Univ Grad Sch Med Human Hlth Sci Kyoto Japan Teikyo Univ Sch Med Dept Palliat Med Tokyo Japan Daiichi Sankyo R&D Div Biostat & Data Management Dept Tokyo Japan

Background: In Japan, there are limited options for switching opioid analgesics. Hydromorphone is an opioid analgesic that is routinely used instead of morphine for cancer pain;however, it is not yet available in Japan. The aim of this study was to assess the efficacy and safety of hydromorphone (dS-7113b) extended-release tablets in opioid-naive patients with cancer pain not relieved by non-opioid analgesics. Subjects and methods: This was a multicenter, randomized, double-blind, parallel-group trial. A double-dummy method was used for blinding. Each randomized subject received either hydromorphone extended-release tablets plus placebo oxycodone hydrochloride extended-release tablets 4 mg/day (n=88) or placebo hydromorphone extended-release tablets plus oxycodone hydrochloride extended-release tablets 10 mg/day (n=93) orally for 7 days (once-daily dosing for hydromorphone and twice-daily dosing for oxycodone). The doses were adjusted as necessary. Efficacy was evaluated by change in visual analog scale (VAS) score from baseline to completion of treatment. results: The between-group difference in least squares mean changes in VAS score from baseline to completion or discontinuation of treatment was -0.4 mm (95% CI -5.9 to 5 mm) by analysis of covariance where the baseline VAS score was used as a covariate. The upper limit of the 95% CI was below 10 mm, which was predefined as the noninferiority limit. This verified the noninferiority of hydromorphone tablets relative to oxycodone tablets. The incidence of adverse events was 80.7% (71 of 88) in the hydromorphone group and 83.7% (77 of 93) in the oxycodone group. The most common adverse events were nausea, vomiting, somnolence, diarrhea, and constipation, most of which are commonly observed with opioid analgesics. Conclusion: The efficacy and safety of hydromorphone extended-release tablets were equivalent to those of the oxycodone extended-release formulation.

关键词： hydromorphone oxycodone cancer pain palliative medicine double-blind study

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dS-7300 (B7-H3 dXd antibody-drug conjugate [AdC]) shows durable antitumor activity in advanced solid tumors: Extended follow-up of a phase I/II study

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ANNALS OF ONCOLOGY 2022年第7期33卷 S744-S745页

作者： doi, T. Patel, M. Falchook, G. S. Koyama, T. Friedman, C. F. Piha-Paul, S. Gutierrez, M. E. Abdul-Karim, r. Awad, M. Adkins, d. r. Takahashi, S. Kadowaki, S. Cheng, B. Ikeda, N. Laadem, A. Yoshizuka, N. Qian, M. dosunmu, O. Arkenau, H-T. Johnson, M. L. Natl Canc Ctr Hosp East Dept Expt Therapeut Kashiwa Chiba Japan Florida Canc Specialists & Res Inst Drug Dev Unit Sarasota FL USA Sarah Cannon Res Inst Drug Dev Unit Denver CO USA Natl Canc Ctr Dept Expt Therapeut Tokyo Japan Mem Sloan Kettering Canc Ctr Gynecol Oncol Serv New York NY USA Univ Texas MD Anderson Canc Ctr Dept Invest Canc Therapeut Anderson Canc Ctr Houston TX USA Hackensack Univ John Theurer Canc Ctr Med Ctr Hackensack NJ USA Henry Ford Hlth Med Oncol Henry Ford Canc Inst Detroit MI USA Dana Farber Canc Inst Med Oncol Boston MA USA Washington Univ Div Oncol Dept Med Sch Med St Louis MO USA Japanese Fdn Canc Res Canc Inst Hosp Dept Med Oncol Koto Ku Tokyo Japan Aichi Canc Ctr Hosp Dept Clin Oncol Nagoya Japan Daiichi Sankyo Inc CSPV Basking Ridge NJ USA Daiichi Sankyo Inc Global Oncol R&D Basking Ridge NJ USA Daiichi Sankyo Inc Clin Dev Basking Ridge NJ USA Daiichi Sankyo Inc Biostat & Data Management Basking Ridge NJ USA Sarah Cannon Res Inst Dev Innovat Med Monitoring & Clin Sci Nashville TN USA Sarah Cannon Res Inst Oncol London England Sarah Cannon Res Inst Med Oncol Nashville TN USA

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