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Clinical Benefits as endpoints in Advanced Non-Small Cell Lung Cancer Treated with Integrative Medicine

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Chinese Journal of Integrative Medicine 2011年第2期17卷 228-231页

作者：薛冬李萍萍 Department of Integrative Medicine Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education)Department of Cancer EtiologyPeking University Cancer Hospital and Institute

＂Living with cancer＂ and symptom control are the features and advantages of integrative medicine in advanced non-small cell lung cancer （NSCLC） treatment. However, with the current concept of response evaluation criteria by the WHO and RECIST, it is difficult to exhibit the above characteristics. Clinical benefit （CB） is designed as an endpoint recently widely understood and accepted in oncology clinical trials. With the review of its definition and development, we suggest CB to be used as an endpoint in advanced NSCLC treatment with integrative medicine. CB should encompass two connotations： one is improved quality of life and symptom control and the other is disease control rate （DCR）, including complete response （CR）, partial response （PR）, and stable disease （SD）. We need to design randomized controlled trials （RCT） to investigate the interrelationship of CB rate and survival to provide high-grade evidence proving that advanced lung cancer patients could really benefit from integrative medicine treatment.

关键词： non-small cell lung cancer Chinese medicine endpoints clinical benefit

How Interlinks Influence Federated over SPARQL endpoints

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International Journal of Internet and Distributed Systems 2013年第1期1卷 1-8页

作者： Nur Aini Rakhmawati Digital Enterprise Research Institute National University of Ireland Galway Ireland

As the Web of Data grows, the number of available SPARQL endpoints increases. SPARQL endpoints conceptually represent RPC-style, coarse-grained data access mechanisms. Nevertheless, through the potential interlinking of the contained entities, SPARQL endpoints should be able to over distinct advantages over plain Web APIs. To our knowledge, to date, there has been no study conducted that gauges the impact of the link on SPARQL query execution, especially in a federated set-up. In this paper, we investigate how the existence and types of typed links influences the execution characteristics of different SPARQL federation frameworks. In order to measure the query performance, we propose a combined cost model based on a statistic analysis of the query performance metrics that involves parameters such as type of link, the data catalogues and cache, number of links, and number of distinct subjects. As result, we show that number of distinct subject and number of links have significant impact on Federation over SPARQL endpoints performance whereas type of link does not have significantly influence in federation query performance.

关键词： SPARQL Federation over SPARQL endpoints

Pursuing meaningful end-points for stem cell therapy assessment in ischemic cardiac disease

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World Journal of Stem Cells 2017年第12期9卷 203-218页

作者： Maria Dorobantu Nicoleta-Monica Popa-Fotea Mihaela Popa Iulia Rusu Miruna Mihaela Micheu Department of Cardiology Clinical Emergency Hospital of Bucharest Carol Davila University of Medicine 'Carol Davila' University of Medicine and Pharmacy Bucharest

Despite optimal interventional and medical therapy, ischemic heart disease is still an important cause of morbidity and mortality worldwide. Although not included in standard of care rehabilitation, stem cell therapy(SCT) could be a solution for prompting cardiac regeneration. Multiple studies have been published from the beginning of SCT until now, but overall no unanimous conclusion could be drawn in part due to the lack of appropriate endpoints. In order to appreciate the impact of SCT, multiple markers from different categories should be considered: Structural, biological, functional, physiological, but also major adverse cardiac events or quality of life. Imaging end-points are among the most used-especially left ventricle ejection fraction(LVEF) measured through different methods. Other imaging parameters are infarct size, myocardial viability and perfusion. The impact of SCT on all of the aforementioned end-points is controversial and debatable. 2 D-echocardiography is widely exploited, but new approaches such as tissue Doppler, strain/strain rate or 3 D-echocardiography are more accurate, especially since the latter one is comparable with the MRI gold standard estimation of LVEF. Apart from the objective parameters, there are also patient-centered evaluations to reveal the benefits of SCT, such as quality of life and performance status, the most valuable from the patient point of view. Emerging parameters investigating molecular pathways such as non-coding RNAs or inflammation cytokines have a high potential as prognostic factors. Due to the disadvantages of current techniques, new imaging methods with labelled cells tracked along their lifetime seem promising, but until now only pre-clinical trials have been conducted in humans. Overall, SCT is characterized by high heterogeneity not only in preparation, administration and type of cells, but also in quantification of therapy effects.

关键词： Stem cell therapy Cardiac imaging techniques Ischemic cardiac disease Cardiac regeneration endpoints

Combination antiretroviral studies for patients with primary biliary cirrhosis

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World Journal of Gastroenterology 2016年第1期22卷 349-360页

作者： Ellina Lytvyak Aldo J Montano-Loza Andrew L Mason Division of Gastroenterology and Hepatology University of Alberta

Following the characterization of a human betaretrovirus in patients with primary biliary cirrhosis(PBC),pilot studies using antiretroviral therapy have been conducted as proof of principal to establish a link of virus with disease and with the eventual aim to find better adjunct therapies for patients unresponsive to ursodeoxycholic *** the first open label pilot study,the reverse transcriptase inhibitor lamivudine had little demonstrable biochemical or histological effect after 1 ***,lamivudine in combination with zidovudine was associated with a significant reduction in alkaline phosphatase as well as improvement in necroinflammatory score,cholangitis and ductopenia over a 12 mo period.A double blind,multi-center randomized controlled trial using lamivudine with zidovudine for 6 mo confirmed a significant reduction in alkaline phosphatase,ALT and AST in patients on antiviral ***,none of the patients achieved the stringent endpoint criteria for normalization of alkaline ***,some patients developed biochemical rebound consistent with drug resistance.A major fault of these studies has been the inability to measure the viral load in peripheral blood and therefore,provide a direct correlation between improvement of hepatic biochemistry and reduction in viral ***,viral mutants to lamivudine with zidovudine were later characterized in the NOD.c3c4 mouse model of PBC that has been used to test other antiretroviral regimens to *** combination of tenofovir and emtricitabine reverse transcriptase inhibitors and the HIV protease inhibitor,lopinavir were found to abrogate cholangitis in the NOD.c3c4 mouse model and the same regimen normalized the liver tests in a PBC patient with HIV and human betaretrovirus *** combination antiretroviral therapy has now been used in a double blind randomized controlled crossover study for patients with PBC followed by an open label extension *** a thi

关键词： Primary biliary cirrhosis Antiretroviraltherapy Human betaretrovirus Randomized controlledtrial endpoints for trials

Recurrence-free survival as a putative surrogate for overall survival in phase Ⅲ trials of curative-intent treatment of colorectal liver metastases:Systematic review

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World Journal of Clinical Oncology 2017年第3期8卷 266-272页

作者： Raphael LC Araujo Paulo Herman Rachel P Riechelmann Department of Upper Gastrointestinal and Hepato-Pancreato-Bliliary Sugery Barretos Cancer Hospital Department of Gastroenterology University of S?o Paulo Instituto do Cancer do Estado de S?o Paulo Universidade de S?o Paulo

AIM To verify whether recurrence-free survival(RFS) surrogates overall survival(OS) in phase Ⅲ trials for resectable colorectal liver metastases(CRLM).METHODS MEDLINE,EMBASE,and Scopus databases were *** studies were phase Ⅲ trials testing any type of systemic therapy(neoadjuvant,adjuvant or perioperative) added to surgery in patients with resectable CRLM.A linear regression model based on hazard ratios(HR) of OS and RFS was *** Of 3059 studies,5 phase Ⅲ trials(1162 patients) were included for analyses.A linear regression weighted by each trial was used to estimate the association between each HR and *** originated formula was:OS HR =(0.93 × RFS HR) + 0.14;with RFS 95%CI(0.48-1.38),with P = *** This association suggests that RFS could work as a putative surrogate endpoint of OS in this population,avoiding bigger,longer and more resource-consuming *** OS could be assumed based on RFS and our model could be useful to better estimate sample size calculations of phase Ⅲ trials of CRLM aiming for OS.

关键词： Colorectal liver metastases Surgery Chemotherapy Clinical trial Long-term outcomes Surrogate endpoints

The Products of Regularly Solvable Operators with Their Spectra in Direct Sum Spaces

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Advances in Pure Mathematics 2013年第4期3卷 415-429页

作者： Sobhy El-Sayed Ibrahim Department of Mathematics Faculty of Science Benha University Benha Egypt

In this paper, we consider the general quasi-differential expressions each of order n with complex coefficients and their formal adjoints on the interval (a,b). It is shown in direct sum spaces of functions defined on each of the separate intervals with the cases of one and two singular end-points and when all solutions of the equation and its adjoint are in (the limit circle case) that all well-posed extensions of the minimal operator have resolvents which are HilbertSchmidt integral operators and consequently have a wholly discrete spectrum. This implies that all the regularly solvable operators have all the standard essential spectra to be empty. These results extend those of formally symmetric expression studied in [1-10] and those of general quasi-differential expressions in [11-19].

关键词： Product of Quasi-Differential Expressions Regular and Singular endpoints Regularly Solvable Operators Essential Spectra Hilbert-Schmidt Integral Operators

Responses of Aquatic Vegetation to Pollution: Preliminary Results on Ecotoxicological Effects and Bioenrichment Factors

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Journal of Environmental Protection 2014年第4期5卷 274-288页

作者： Monia Renzi Andrea Giovani Silvano E. Focardi Department of Biological and Environmental Sciences and Technologies University of the Salento SP Lecce-Monteroni Lecce Italy Department of Physical Hearth and Environmental Sciences University of Siena Via P.A. Mattioli 4 Siena Italy

This study evaluates, on a preliminary basis, the principal morpho-physiological effects induced by pollution stress in four aquatic vegetation species of great ecological relevance in transitional water ecosystems. Three macroalgae (Chaetomorpha linum, Valonia aegagrophyla, Graciliariopsis longissima) and one phanerogams species (Ruppia cirrhosa) were exposed to different doses of trace elements (Cu, Hg, Zn) and surfactants (dodecylbenzenesulfonic acid sodium salt) in laboratory controlled microcosm conditions and morpho-physiological responses (photosynthetic complex alteration, percentage of died cells, morphological changes) were measured before and after 7 and 14 days of exposure. Levels of pollutants in tissues and BioConcentration Factors (BCF) for each species were calculated after 14 days of exposure. Results suggest that photosynthetic complex alteration can be a useful tool to evaluate early and sub-lethal significant changes due to exposure to pollution stress in all of the considered species. A clear species-specificity was observed concerning trace element levels in tissues after 14 days of exposure, while dose-dependent behavior was observed for BCFs.

关键词： Morpho-Physiological endpoints Trace Elements Surfactants BCFs Macrophytes Macroalgae

Determining Environmental Impacts for Sensitive Species: Using Iconic Species as Bioindicators for Management and Policy

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Journal of Environmental Protection 2013年第8期4卷 87-95页

作者： Joanna Burger Michael Gochfeld Charles W. Powers James H. Clarke Kevin Brown David Kosson Lawrence Niles Amanda Dey Christian Jeitner Taryn Pittfield 1Consortium for Risk Evaluation with Stakeholder Participation Vanderbilt University Nashville USA 2Department of Civil and Environmental Engineering and CRESP Vanderbilt University Nashville USA 1Consortium for Risk Evaluation with Stakeholder Participation Vanderbilt University Nashville USA 2Department of Civil and Environmental Engineering and CRESP Vanderbilt University Nashville USA 1Division of Life Sciences Rutgers University Piscataway USA 2Environmental and Occupational Health Sciences Institute Rutgers University Piscataway USA 3Consortium for Risk Evaluation with Stakeholder Participation Vanderbilt University Nashville USA 1Environmental and Occupational Health Sciences Institute Rutgers University Piscataway USA 2Consortium for Risk Evaluation with Stakeholder Participation Vanderbilt University Nashville USA 3Environmental and Occupational Medicine Rutgers-Robert Wood Johnson Medical School Piscataway USA Conserve Wildlife Foundation of New Jersey Greenwich USA Endangered and Nongame Species Program Department of Environmental Protection Trenton USA.

Environmental assessment of impacts, management, and policy are important aspects of protection of human health and the environment. Assessing the impacts of human activities requires selection of bioindicator species that can be used to assess, manage, and develop public policies that ensure ecosystem integrity, and therefore sustainability of social, cultural, and economic systems. With the use of Chinook Salmon (Oncorhynchus tshawytscha), Pacific Cod (Gadusmacrocephalus), Mallard (Anas platyrhynchos), and Red Knot (Calidris canutus rufa), we explore assessment and measurement endpoints, and their relationship to management and development of public policy. This combination of fish and birds provides a diversity of life histories, ecosystem roles, human values, and resource use to explore their use as bioindicators and endpoints. It also allows examination of 1) conservation and protection of species and biodiversity, 2) protection of ecosystems, 3) provision of goods and services, and 4) societal well-being.

关键词： Assessment Bioindicators Contaminants endpoints Management Public Policy Fish Birds