Advancing clinical reasoning in virtual patients – development and application of a conceptual framework

PubMed Central

Hege, Inga; Kononowicz, Andrzej A.; Berman, Norman B.; Lenzer, Benedikt; Kiesewetter, Jan

2018-01-01

Background: Clinical reasoning is a complex skill students have to acquire during their education. For educators it is difficult to explain their reasoning to students, because it is partly an automatic and unconscious process. Virtual Patients (VPs) are used to support the acquisition of clinical reasoning skills in healthcare education. However, until now it remains unclear which features or settings of VPs optimally foster clinical reasoning. Therefore, our aims were to identify key concepts of the clinical reasoning process in a qualitative approach and draw conclusions on how each concept can be enhanced to advance the learning of clinical reasoning with virtual patients. Methods: We chose a grounded theory approach to identify key categories and concepts of learning clinical reasoning and develop a framework. Throughout this process, the emerging codes were discussed with a panel of interdisciplinary experts. In a second step we applied the framework to virtual patients. Results: Based on the data we identified the core category as the "multifactorial nature of learning clinical reasoning". This category is reflected in the following five main categories: Psychological Theories, Patient-centeredness, Context, Learner-centeredness, and Teaching/Assessment. Each category encompasses between four and six related concepts. Conclusions: With our approach we were able to elaborate how key categories and concepts of clinical reasoning can be applied to virtual patients. This includes aspects such as allowing learners to access a large number of VPs with adaptable levels of complexity and feedback or emphasizing dual processing, errors, and uncertainty. PMID:29497697

Clinical translation of handheld optical coherence tomography: practical considerations and recent advancements

NASA Astrophysics Data System (ADS)

Monroy, Guillermo L.; Won, Jungeun; Spillman, Darold R.; Dsouza, Roshan; Boppart, Stephen A.

2017-12-01

Since the inception of optical coherence tomography (OCT), advancements in imaging system design and handheld probes have allowed for numerous advancements in disease diagnostics and characterization of the structural and optical properties of tissue. OCT system developers continue to reduce form factor and cost, while improving imaging performance (speed, resolution, etc.) and flexibility for applicability in a broad range of fields, and nearly every clinical specialty. An extensive array of components to construct customized systems has also become available, with a range of commercial entities that produce high-quality products, from single components to full systems, for clinical and research use. Many advancements in the development of these miniaturized and portable systems can be linked back to a specific challenge in academic research, or a clinical need in medicine or surgery. Handheld OCT systems are discussed and explored for various applications. Handheld systems are discussed in terms of their relative level of portability and form factor, with mention of the supporting technologies and surrounding ecosystem that bolstered their development. Additional insight from our efforts to implement systems in several clinical environments is provided. The trend toward well-designed, efficient, and compact handheld systems paves the way for more widespread adoption of OCT into point-of-care or point-of-procedure applications in both clinical and commercial settings.

[Advanced Parkinson's disease: clinical characteristics and treatment (part 1)].

PubMed

Kulisevsky, J; Luquin, M R; Arbelo, J M; Burguera, J A; Carrillo, F; Castro, A; Chacón, J; García-Ruiz, P J; Lezcano, E; Mir, P; Martinez-Castrillo, J C; Martínez-Torres, I; Puente, V; Sesar, A; Valldeoriola-Serra, F; Yañez, R

2013-10-01

A large percentage of patients with Parkinson's disease (PD) develop motor fluctuations, dyskinesias, and severe non-motor symptoms within 3 to 5 years of starting dopaminergic therapy, and these motor complications are refractory to treatment. Several authors refer to this stage of the disease as advanced Parkinson's disease. To define the clinical manifestations of advanced PD and the risk factors for reaching this stage of the disease. This consensus document has been prepared by using an exhaustive literature search and by discussion of the contents by an expert group on movement disorders of the Sociedad Española de Neurología (Spanish Neurology Society), coordinated by two of the authors (JK and MRL). Severe motor fluctuations and dyskinesias, axial motor symptoms resistant to levodopa, and cognitive decline are the main signs in the clinical phenotype of advanced PD. Copyright © 2013 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

CE: Original Research: Creating an Evidence-Based Progression for Clinical Advancement Programs.

PubMed

Burke, Kathleen G; Johnson, Tonya; Sites, Christine; Barnsteiner, Jane

2017-05-01

: Background: The Institute of Medicine (IOM) and the Quality and Safety Education for Nurses (QSEN) project have identified six nursing competencies and supported their integration into undergraduate and graduate nursing curricula nationwide. But integration of those competencies into clinical practice has been limited, and evidence for the progression of competency proficiency within clinical advancement programs is scant. Using an evidence-based approach and building on the competencies identified by the IOM and QSEN, a team of experts at an academic health system developed eight competency domains and 186 related knowledge, skills, and attitudes (KSAs) for professional nursing practice. The aim of our study was to validate the eight identified competencies and 186 related KSAs and determine their developmental progression within a clinical advancement program. Using the Delphi technique, nursing leadership validated the newly identified competency domains and KSAs as essential to practice. Clinical experts from 13 Magnet-designated hospitals with clinical advancement programs then participated in Delphi rounds aimed at reaching consensus on the developmental progression of the 186 KSAs through four levels of clinical advancement. Two Delphi rounds resulted in consensus by the expert participants. All eight competency domains were determined to be essential at all four levels of clinical practice. At the novice level of practice, the experts identified a greater number of KSAs in the domains of safety and patient- and family-centered care. At more advanced practice levels, the experts identified a greater number of KSAs in the domains of professionalism, teamwork, technology and informatics, and continuous quality improvement. Incorporating the eight competency domains and the 186 KSAs into a framework for clinical advancement programs will likely result in more clearly defined role expectations; enhance accountability; and elevate and promote nursing practice

Exploring the scope of expanding advanced nursing practice in nurse-led clinics: a multiple-case study.

PubMed

Shiu, Ann T Y; Lee, Diana T F; Chau, Janita P C

2012-08-01

This article is a report on a study to explore the development of expanding advanced nursing practice in nurse-led clinics in Hong Kong. Nurse-led clinics serviced by advanced practice nurses, a common international practice, have been adopted in Hong Kong since 1990s. Evaluations consistently show that this practice has good clinical outcomes and contributes to containing healthcare cost. However, similar to the international literature, it remains unclear as to what the elements of good advanced nursing practice are, and which directions Hong Kong should adopt for further development of such practice. A multiple-case study design was adopted with six nurse-led clinics representing three specialties as six case studies, and including two clinics each from continence, diabetes and wound care. Each case had four embedded units of analysis. They included non-participant observation of nursing activities (9 days), nurse interviews (N = 6), doctor interviews (N = 6) and client interviews (N = 12). The data were collected in 2009. Within- and cross-case analyses were conducted. The cross-case analysis demonstrated six elements of good advanced nursing practice in nurse-led clinics, and showed a great potential to expand the practice by reshaping four categories of current boundaries, including community-hospital, wellness-illness, public-private and professional-practice boundaries. From these findings, we suggest a model to advance the scope of advanced nursing practice in nurse-led clinics. The six elements may be applied as audit criteria for evaluation of advanced nursing practice in nurse-led clinics, and the proposed model provides directions for expanding such practice in Hong Kong and beyond. © 2011 Blackwell Publishing Ltd.

Clinical leadership development and education for nurses: prospects and opportunities

PubMed Central

Joseph, M Lindell; Huber, Diane L

2015-01-01

With the implementation of the Affordable Care Act, elevated roles for nurses of care coordinator, clinical nurse leader, and advanced practice registered nurse have come to the forefront. Because change occurs so fast, matching development and education to job requirements is a challenging forecasting endeavor. The purpose of this article is to envision clinical leadership development and education opportunities for three emerging roles. The adoption of a common framework for intentional leadership development is proposed for clinical leadership development across the continuum of care. Solutions of innovation and interdependency are framed as core concepts that serve as an opportunity to better inform clinical leadership development and education. Additionally, strategies are proposed to advance knowledge, skills, and abilities for crucial implementation of improvements and new solutions at the point of care. PMID:29355179

Gastroenterology in developing countries: Issues and advances

PubMed Central

Mandeville, Kate L; Krabshuis, Justus; Ladep, Nimzing Gwamzhi; Mulder, Chris JJ; Quigley, Eamonn MM; Khan, Shahid A

2009-01-01

Developing countries shoulder a considerable burden of gastroenterological disease. Infectious diseases in particular cause enormous morbidity and mortality. Diseases which afflict both western and developing countries are often seen in more florid forms in poorer countries. Innovative techniques continuously improve and update gastroenterological practice. However, advances in diagnosis and treatment which are commonplace in the West, have yet to reach many developing countries. Clinical guidelines, based on these advances and collated in resource-rich environments, lose their relevance outside these settings. In this two-part review, we first highlight the global burden of gastroenterological disease in three major areas: diarrhoeal diseases, hepatitis B, and Helicobacter pylori. Recent progress in their management is explored, with consideration of future solutions. The second part of the review focuses on the delivery of clinical services in developing countries. Inadequate numbers of healthcare workers hamper efforts to combat gastroenterological disease. Reasons for this shortage are examined, along with possibilities for increased specialist training. Endoscopy services, the mainstay of gastroenterology in the West, are in their infancy in many developing countries. The challenges faced by those setting up a service are illustrated by the example of a Nigerian endoscopy unit. Finally, we highlight the limited scope of many clinical guidelines produced in western countries. Guidelines which take account of resource limitations in the form of “cascades” are advocated in order to make these guidelines truly global. Recognition of the different working conditions facing practitioners worldwide is an important step towards narrowing the gap between gastroenterology in rich and poor countries. PMID:19533805

Clinical development of Ebola vaccines

PubMed Central

Sridhar, Saranya

2015-01-01

The ongoing outbreak of Ebola virus disease in West Africa highlighted the lack of a licensed drug or vaccine to combat the disease and has renewed the urgency to develop a pipeline of Ebola vaccines. A number of different vaccine platforms are being developed by assessing preclinical efficacy in animal models and expediting clinical development. Over 15 different vaccines are in preclinical development and 8 vaccines are now in different stages of clinical evaluation. These vaccines include DNA vaccines, virus-like particles and viral vectors such as live replicating vesicular stomatitis virus (rVSV), human and chimpanzee adenovirus, and vaccinia virus. Recently, in preliminary results reported from the first phase III trial of an Ebola vaccine, the rVSV-vectored vaccine showed promising efficacy. This review charts this rapidly advancing area of research focusing on vaccines in clinical development and discusses the future opportunities and challenges faced in the licensure and deployment of Ebola vaccines. PMID:26668751

Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

PubMed

Ozols, Robert F; Herbst, Roy S; Colson, Yolonda L; Gralow, Julie; Bonner, James; Curran, Walter J; Eisenberg, Burton L; Ganz, Patricia A; Kramer, Barnett S; Kris, Mark G; Markman, Maurie; Mayer, Robert J; Raghavan, Derek; Reaman, Gregory H; Sawaya, Raymond; Schilsky, Richard L; Schuchter, Lynn M; Sweetenham, John W; Vahdat, Linda T; Winn, Rodger J

2007-01-01

A MESSAGE FROM ASCO's PRESIDENT For the second consecutive year, the American Society of Clinical Oncology (ASCO) is publishing Clinical Cancer Advances: Major Research Advances in Cancer Treatment, Prevention, and Screening, an annual review of the most significant cancer research presented or published over the past year. ASCO developed this report to demonstrate the enormous progress being made on the front lines of cancer research today. The report is intended to give all those with an interest in cancer care-the general public, cancer patients and physicians, policymakers, oncologists, and other medical professionals-an accessible summary of the year's most important cancer research advances. These pages report on new targeted therapies that are improving survival and response rates in hard-to-treat cancers such as kidney cancer, HER-2-positive breast cancer, head and neck cancer, and chronic myelogenous leukemia; the FDA's approval of the world's first preventive vaccine for human papillomavirus (HPV), which has the potential to dramatically reduce the global burden of cervical cancer; and advances in the fast-growing field of personalized medicine, including a new lung cancer test that could help physicians better target treatments and predict prognosis. These advances are only part of the landscape. Survival rates are on the rise, the number of cancer deaths in the United States began declining for the first time since 1930, and new research is showing that the rates of certain common cancers, such as those of the breast and colon, have stabilized, and may have even begun to decline. However, cancer research still faces a number of major obstacles. At a time of extraordinary scientific potential, declining federal funding of cancer research threatens to stall or even reverse recent progress. Such funding cuts have already led to fewer clinical trials, fewer talented young physicians entering the field, and a growing bottleneck of basic science discoveries

Clinical skill development for community pharmacists.

PubMed

Barnette, D J; Murphy, C M; Carter, B L

1996-09-01

The importance of establishing clinical pharmacy services in the community cannot be understated in light of current challenges to the traditional dispensing role as the primary service of the community pharmacist. Advancements in automated dispensing technology and declining prescription fee reimbursement are rapidly forcing pharmacists to seek alternative sources of revenue. Providing pharmaceutical care is a viable option to increase customer loyalty job satisfaction, and reimbursement. To support the development of clinical services, academic institutions are forming partnerships with individual community practitioners to overcome perceived educational and training barriers. The authors describe the design and development of two unique clinical skill development programs at the University of Illinois at Chicago. This paper also outlines the patient focused services that the participants have established upon completing the training. These programs successfully enhanced participants' therapeutic knowledge base and facilitated development of the clinical skills necessary for direct patient care.

Clinical cancer advances 2007: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

PubMed

Gralow, Julie; Ozols, Robert F; Bajorin, Dean F; Cheson, Bruce D; Sandler, Howard M; Winer, Eric P; Bonner, James; Demetri, George D; Curran, Walter; Ganz, Patricia A; Kramer, Barnett S; Kris, Mark G; Markman, Maurie; Mayer, Robert J; Raghavan, Derek; Ramsey, Scott; Reaman, Gregory H; Sawaya, Raymond; Schuchter, Lynn M; Sweetenham, John W; Vahdat, Linda T; Davidson, Nancy E; Schilsky, Richard L; Lichter, Allen S

2008-01-10

A MESSAGE FROM ASCO'S PRESIDENT: For the third year, the American Society of Clinical Oncology (ASCO) is publishing Clinical Cancer Advances: Major Research Advances in Cancer Treatment, Prevention, and Screening, an annual review of the most significant cancer research presented or published over the past year. ASCO publishes this report to demonstrate the important progress being made on the front lines of clinical cancer research today. The report is intended to give all those with an interest in cancer care-the general public, cancer patients and organizations, policymakers, oncologists, and other medical professionals-an accessible summary of the year's most important cancer research advances. These pages report on the use of magnetic resonance imaging for breast cancer screening, the association between hormone replacement therapy and breast cancer incidence, the link between human papillomavirus and head and neck cancers, and the use of radiation therapy to prevent lung cancer from spreading. They also report on effective new targeted therapies for cancers that have been historically difficult to treat, such as liver cancer and kidney cancer, among many others. A total of 24 advances are featured in this year's report. These advances and many more over the past several years show that the nation's long-term investment in cancer research is paying off. But there are disturbing signs that progress could slow. We are now in the midst of the longest sustained period of flat government funding for cancer research in history. The budgets for the National Institutes of Health and the National Cancer Institute (NCI) have been unchanged for four years. When adjusted for inflation, cancer research funding has actually declined 12% since 2004. These budget constraints limit the NCI's ability to fund promising cancer research. In the past several years the number of grants that the NCI has been able to fund has significantly decreased; this year, in response to just the

Novel drugs in clinical development for hepatocellular carcinoma.

PubMed

Waidmann, Oliver; Trojan, Jörg

2015-01-01

Sorafenib is the only systemic drug approved for the treatment of advanced hepatocellular carcinoma (HCC). Within recent years, several investigational agents mainly targeting angiogenesis failed in late-phase clinical development either due to toxicity or lack of benefit. This review covers recent clinical data on systemic agents and ongoing trials in patients with advanced HCC. In unselected patients with advanced HCC, disappointing results have been reported from several large trials. However, in two subgroups encouraging results have been achieved. Treatment with the MET inhibitor tivantinib resulted in a substantial survival benefit in the subgroup of MET overexpressing tumors in a randomized Phase II trial. Furthermore, the vascular endothelial growth factor receptor 2 antibody ramucirumab resulted in improved overall survival in patients with baseline α-fetoprotein (AFP) ≥ 400 ng/ml in a Phase III trial. These two agents, and several others, will be further developed in HCC. Moreover, immunotherapeutics such as checkpoint inhibitors, programmed death receptor-1 blocking antibodies and oncolytic viruses are under investigation in advanced HCC.

Transforming RN education: clinical learning and clinical knowledge development.

PubMed

Benner, P

1993-04-01

Transforming RN education has the potential for transforming clinical teaching and learning for all students. The returning RN student offers possibilities for clinical learning that the generic student does not have, but this should not cause us to limit the returning RN student to the generic level. Where possible innovative programs should be developed to move the RN student from baccalaureate level to the Master's level. As educators, we should take the opportunity to increase the numbers of nurses who are educationally prepared to move into advanced levels of practice. The returning RN student offers a rich human resource for the profession, and a rich resource for improving our clinical teaching as well as our practice.

Clinical Advancements in the Targeted Therapies against Liver Fibrosis

PubMed Central

Nagórniewicz, Beata; Prakash, Jai

2016-01-01

Hepatic fibrosis, characterized by excessive accumulation of extracellular matrix (ECM) proteins leading to liver dysfunction, is a growing cause of mortality worldwide. Hepatocellular damage owing to liver injury leads to the release of profibrotic factors from infiltrating inflammatory cells that results in the activation of hepatic stellate cells (HSCs). Upon activation, HSCs undergo characteristic morphological and functional changes and are transformed into proliferative and contractile ECM-producing myofibroblasts. Over recent years, a number of therapeutic strategies have been developed to inhibit hepatocyte apoptosis, inflammatory responses, and HSCs proliferation and activation. Preclinical studies have yielded numerous targets for the development of antifibrotic therapies, some of which have entered clinical trials and showed improved therapeutic efficacy and desirable safety profiles. Furthermore, advancements have been made in the development of noninvasive markers and techniques for the accurate disease assessment and therapy responses. Here, we focus on the clinical developments attained in the field of targeted antifibrotics for the treatment of liver fibrosis, for example, small molecule drugs, antibodies, and targeted drug conjugate. We further briefly highlight different noninvasive diagnostic technologies and will provide an overview about different therapeutic targets, clinical trials, endpoints, and translational efforts that have been made to halt or reverse the progression of liver fibrosis. PMID:27999454

Application development environment for advanced digital workstations

NASA Astrophysics Data System (ADS)

Valentino, Daniel J.; Harreld, Michael R.; Liu, Brent J.; Brown, Matthew S.; Huang, Lu J.

1998-06-01

One remaining barrier to the clinical acceptance of electronic imaging and information systems is the difficulty in providing intuitive access to the information needed for a specific clinical task (such as reaching a diagnosis or tracking clinical progress). The purpose of this research was to create a development environment that enables the design and implementation of advanced digital imaging workstations. We used formal data and process modeling to identify the diagnostic and quantitative data that radiologists use and the tasks that they typically perform to make clinical decisions. We studied a diverse range of radiology applications, including diagnostic neuroradiology in an academic medical center, pediatric radiology in a children's hospital, screening mammography in a breast cancer center, and thoracic radiology consultation for an oncology clinic. We used object- oriented analysis to develop software toolkits that enable a programmer to rapidly implement applications that closely match clinical tasks. The toolkits support browsing patient information, integrating patient images and reports, manipulating images, and making quantitative measurements on images. Collectively, we refer to these toolkits as the UCLA Digital ViewBox toolkit (ViewBox/Tk). We used the ViewBox/Tk to rapidly prototype and develop a number of diverse medical imaging applications. Our task-based toolkit approach enabled rapid and iterative prototyping of workstations that matched clinical tasks. The toolkit functionality and performance provided a 'hands-on' feeling for manipulating images, and for accessing textual information and reports. The toolkits directly support a new concept for protocol based-reading of diagnostic studies. The design supports the implementation of network-based application services (e.g., prefetching, workflow management, and post-processing) that will facilitate the development of future clinical applications.

Recent technological advances in computed tomography and the clinical impact therein.

PubMed

Runge, Val M; Marquez, Herman; Andreisek, Gustav; Valavanis, Anton; Alkadhi, Hatem

2015-02-01

Current technological advances in CT, specifically those with a major impact on clinical imaging, are discussed. The intent was to provide for both medical physicists and practicing radiologists a summary of the clinical impact of each advance, offering guidance in terms of utility and day-to-day clinical implementation, with specific attention to radiation dose reduction.

Barriers and strategies for the clinical translation of advanced orthopaedic tissue engineering protocols.

PubMed

Madry, H; Alini, M; Stoddart, M J; Evans, C; Miclau, T; Steiner, S

2014-05-06

Research in orthopaedic tissue engineering has intensified over the last decade and new protocols continue to emerge. The clinical translation of these new applications, however, remains associated with a number of obstacles. This report highlights the major issues that impede the clinical translation of advanced tissue engineering concepts, discusses strategies to overcome these barriers, and examines the need to increase incentives for translational strategies. The statements are based on presentations and discussions held at the AO Foundation-sponsored symposium "Where Science meets Clinics 2013" held at the Congress Center in Davos, Switzerland, in September, 2013. The event organisers convened a diverse group of over one hundred stakeholders involved in clinical translation of orthopaedic tissue engineering, including scientists, clinicians, healthcare industry professionals and regulatory agency representatives. A major point that emerged from the discussions was that there continues to be a critical need for early trans-disciplinary communication and collaboration in the development and execution of research approaches. Equally importantly was the need to address the shortage of sustained funding programs for multidisciplinary teams conducting translational research. Such detailed discussions between experts contribute towards the development of a roadmap to more successfully advance the clinical translation of novel tissue engineering concepts and ultimately improve patient care in orthopaedic and trauma surgery.

Advancing the educational and career pathway for clinical trials nurses.

PubMed

Scott, Kathleen; White, Kathryn; Roydhouse, Jessica K

2013-04-01

Clinical trials nurses play a pivotal role in the conduct of clinical research, but the educational and career pathway for these nurses remains unclear. This article reports findings from a survey of nurses working in cancer clinical trials research in Australia. Most participants held postgraduate qualifications (42 of 61); however, clinical trials education was primarily attained through short professional development courses. Interest in pursuing trial-specific postgraduate education was high, but barriers were identified, including cost, time, and unclear benefit for career advancement. Job titles varied substantially, which is indicative of an unclear employment pathway. These findings suggest that initiatives to improve the educational and career pathway for clinical trials nurses are needed and should include the following: formal educational preparation, greater consistency in employment status, and clearer career progression. These strategies should be underpinned by broad professional recognition of the clinical trials nurse as a specialized nursing role. Copyright 2013, SLACK Incorporated.

Management of advanced pancreatic cancer with gemcitabine plus erlotinib: efficacy and safety results in clinical practice.

PubMed

Diaz Beveridge, Robert; Alcolea, Vicent; Aparicio, Jorge; Segura, Ángel; García, Jose; Corbellas, Miguel; Fonfría, María; Giménez, Alejandra; Montalar, Joaquin

2014-01-10

The combination of gemcitabine and erlotinib is a standard first-line treatment for unresectable, locally advanced or metastatic pancreatic cancer. We reviewed our single centre experience to assess its efficacy and toxicity in clinical practice. Clinical records of patients with unresectable, locally advanced or metastatic pancreatic cancer who were treated with the combination of gemcitabine and erlotinib were reviewed. Univariate survival analysis and multivariate analysis were carried out to indentify independent predictors factors of overall survival. Our series included 55 patients. Overall disease control rate was 47%: 5% of patients presented complete response, 20% partial response and 22% stable disease. Median overall survival was 8.3 months). Cox regression analysis indicated that performance status and locally advanced versus metastatic disease were independent factors of overall survival. Patients who developed acne-like rash toxicity, related to erlotinib administration, presented a higher survival than those patients who did not develop this toxicity. Gemcitabine plus erlotinib doublet is active in our series of patients with advanced pancreatic cancer. This study provides efficacy and safety results similar to those of the pivotal phase III clinical trial that tested the same combination.

Design of clinical trials for therapeutic cancer vaccines development.

PubMed

Mackiewicz, Jacek; Mackiewicz, Andrzej

2009-12-25

Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate.

Realization of Real-Time Clinical Data Integration Using Advanced Database Technology

PubMed Central

Yoo, Sooyoung; Kim, Boyoung; Park, Heekyong; Choi, Jinwook; Chun, Jonghoon

2003-01-01

As information & communication technologies have advanced, interest in mobile health care systems has grown. In order to obtain information seamlessly from distributed and fragmented clinical data from heterogeneous institutions, we need solutions that integrate data. In this article, we introduce a method for information integration based on real-time message communication using trigger and advanced database technologies. Messages were devised to conform to HL7, a standard for electronic data exchange in healthcare environments. The HL7 based system provides us with an integrated environment in which we are able to manage the complexities of medical data. We developed this message communication interface to generate and parse HL7 messages automatically from the database point of view. We discuss how easily real time data exchange is performed in the clinical information system, given the requirement for minimum loading of the database system. PMID:14728271

Adaptation through Collaboration: Developing Novel Platforms to Advance the Delivery of Advanced Therapies to Patients

PubMed Central

Papadaki, Magdalini

2017-01-01

For the nascent field of advanced therapies, collaboration will be a game-changer, turning scientific progress that was once unimaginable into transformative medical practice. Despite promise for lifelong management and even cure of disease, skepticism remains about the feasibility of their delivery to patients, fueling investment risks. With the potential for long-term effectiveness in need of frequent reassessment, current approaches to predict real-life drug performance bear little relevance, necessitating novel and iterative schemes to monitoring the benefit–risk profiles throughout the life span of advanced therapies. This work explains that reinventing an adoption route for Advanced Therapy Medicinal Products is as much about the scientific and clinical components, as it is about the organizational structures, requiring an unprecedented level of interactions between stakeholders not traditionally connected; from developers and regulators, to payers, patients, and funders. By reflecting on the successes and lessons learned from the growing space of global precompetitive consortia and public–private partnerships, as well as a number of emerging accelerated development pathways, this work aims to inform the foundations for a future roadmap that can smooth the path to approval, reimbursement, and access, while delivering value to all stakeholders. Echoing the growing demands to bring these transformative products to patients, it provides critical insights to enhance our capacity in three fundamental domains: deploying the operational flexibilities offered by the growing space of collaborations, utilizing emerging flexible and accelerated pathways to tackle challenges in quantifying long-term effectiveness, and building the necessary digital and clinical infrastructure for knowledge development. PMID:28611985

Test Review: Advanced Clinical Solutions for WAIS-IV and WMS-IV

ERIC Educational Resources Information Center

Chu, Yiting; Lai, Mark H. C.; Xu, Yining; Zhou, Yuanyuan

2012-01-01

The authors review the "Advanced Clinical Solutions for WAIS-IV and WMS-IV". The "Advanced Clinical Solutions (ACS) for the Wechsler Adult Intelligence Scale-Fourth Edition" (WAIS-IV; Wechsler, 2008) and the "Wechsler Memory Scale-Fourth Edition" (WMS-IV; Wechsler, 2009) was published by Pearson in 2009. It is a…

Current status of Zika vaccine development: Zika vaccines advance into clinical evaluation.

PubMed

Barrett, Alan D T

2018-01-01

Zika virus (ZIKV), a mosquito-borne flavivirus, was first identified in the 1940s in Uganda in Africa and emerged in the Americas in Brazil in May 2015. In the 30 months since ZIKV emerged as a major public health problem, spectacular progress has been made with vaccine development cumulating with the publication of three reports of phase 1 clinical trials in the 4th quarter of 2017. Clinical trials involving candidate DNA and purified inactivated virus vaccines showed all were safe and well-tolerated in the small number of volunteers and all induced neutralizing antibodies, although these varied by vaccine candidate and dosing regimen. These results suggest that a Zika vaccine can be developed and that phase 2 clinical trials are warranted. However, it is difficult to compare the results from the different phase 1 studies or with neutralizing antibodies induced by licensed flavivirus vaccines (Japanese encephalitis, tick-borne encephalitis, and yellow fever) as neutralizing antibody assays vary and, unfortunately, there are no standards for Zika virus neutralizing antibodies. In addition to clinical studies, substantial progress continues to be made in nonclinical development, particularly in terms of the ability of candidate vaccines to protect reproductive tissues, and the potential use of monoclonal antibodies for passive prophylaxis.

Advancing staff development and progression in nursing.

PubMed

Narayanasamy, Aru; Narayanasamy, Mani

Staff development in the NHS is integral to clinical governance and therefore important to health service providers. It is concerned with all the activities that advance knowledge, skills and attitudes of staff, embracing induction, mentorship, continuing professional development, learning beyond registration, performance appraisals, promotion, personal and professional development, and related activities. The recent contraction in nursing posts and services and competition for jobs means that only well-qualified staff with an impressive portfolio of staff development are likely to climb the career ladder. Nursing staff development and training needs in the NHS are huge and multifaceted. Healthcare providers need to invest in clear staff development strategies if they are to maintain their status as effective care delivery organizations in an increasingly competitive market-driven economy. This article examines the many features of staff development and highlights the benefits for both staff and organizations.

The Path to Advanced Practice Licensure for Clinical Nurse Specialists in Washington State.

PubMed

Schoonover, Heather

The aim of this study was to provide a review of the history and process to obtaining advanced practice licensure for clinical nurse specialists in Washington State. Before 2016, Washington State licensed certified nurse practitioners, certified nurse midwives, and certified nurse anesthetists under the designation of an advanced registered nurse practitioner; however, the state did not recognize clinical nurse specialists as advanced practice nurses. The work to drive the rule change began in 2007. The Washington Affiliate of the National Association of Clinical Nurse Specialists used the Power Elite Theory to guide advocacy activities, building coalitions and support for the desired rule changes. On January 8, 2016, the Washington State Nursing Care Quality Assurance Commission voted to amend the state's advanced practice rules, including clinical nurse specialists in the designation of an advanced practice nurse. Since the rule revision, clinical nurse specialists in Washington State have been granted advanced registered nurse practitioner licenses. Driving changes in state regulatory rules requires diligent advocacy, partnership, and a deep understanding of the state's rule-making processes. To be successful in changing rules, clinical nurse specialists must build strong partnerships with key influencers and understand the steps in practice required to make the desired changes.

Liquid biopsy and its role in an advanced clinical trial for lung cancer.

PubMed

Johann, Donald J; Steliga, Mathew; Shin, Ik J; Yoon, Donghoon; Arnaoutakis, Konstantinos; Hutchins, Laura; Liu, Meeiyueh; Liem, Jason; Walker, Karl; Pereira, Andy; Yang, Mary; Jeffus, Susanne K; Peterson, Erich; Xu, Joshua

2018-02-01

Liquid biopsy methodologies, for the purpose of plasma genotyping of cell-free DNA (cfDNA) of solid tumors, are a new class of novel molecular assays. Such assays are rapidly entering the clinical sphere of research-based monitoring in translational oncology, especially for thoracic malignancies. Potential applications for these blood-based cfDNA assays include: (i) initial diagnosis, (ii) response to therapy and follow-up, (iii) tumor evolution, and (iv) minimal residual disease evaluation. Precision medicine will benefit from cutting-edge molecular diagnostics, especially regarding treatment decisions in the adjuvant setting, where avoiding over-treatment and unnecessary toxicity are paramount. The use of innovative genetic analysis techniques on individual patient tumor samples is being pursued in several advanced clinical trials. Rather than using a categorical treatment plan, the next critical step of therapeutic decision making is providing the "right" cancer therapy for an individual patient, including correct dose and timeframe based on the molecular analysis of the tumor in question. Per the 21st Century Cures Act, innovative clinical trials are integral for biomarker and drug development. This will include advanced clinical trials utilizing: (i) innovative assays, (ii) molecular profiling with cutting-edge bioinformatics, and (iii) clinically relevant animal or tissue models. In this paper, a mini-review addresses state-of-the-art liquid biopsy approaches. Additionally, an on-going advanced clinical trial for lung cancer with novelty through synergizing liquid biopsies, co-clinical trials, and advanced bioinformatics is also presented. Impact statement Liquid biopsy technology is providing a new source for cancer biomarkers, and adds new dimensions in advanced clinical trials. Utilizing a non-invasive routine blood draw, the liquid biopsy provides abilities to address perplexing issues of tumor tissue heterogeneity by identifying mutations in both primary

Innovation at the Intersection of Clinical Trials and Real-World Data Science to Advance Patient Care.

PubMed

Swift, Brandon; Jain, Lokesh; White, Craig; Chandrasekaran, Vasu; Bhandari, Aman; Hughes, Dyfrig A; Jadhav, Pravin R

2018-05-16

While efficacy and safety data collected from randomized clinical trials are the evidentiary standard for determining market authorization, this alone may no longer be sufficient to address the needs of key stakeholders (regulators, providers, and payers) and guarantee long-term success of pharmaceutical products. There is a heightened interest from stakeholders on understanding the use of real-world evidence (RWE) to substantiate benefit-risk assessment and support the value of a new drug. This review provides an overview of real-world data (RWD) and related advances in the regulatory framework, and discusses their impact on clinical research and development. A framework for linking drug development decisions with the value proposition of the drug, utilizing pharmacokinetic-pharmacodynamic-pharmacoeconomic models, is introduced. The summary presented here is based on the presentations and discussion at the symposium entitled Innovation at the Intersection of Clinical Trials and Real-World Data to Advance Patient Care at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2017 Annual Meeting. © 2018 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

PubMed

Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

2016-01-01

Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

Insights into next developments in advanced gastric cancer.

PubMed

Obermannová, Radka; Lordick, Florian

2016-07-01

The purpose of the review is to delineate novel approaches for biology-based treatment in advanced gastric cancer. We reviewed the latest translational and clinical research articles and congress presentations. A new molecular classification of gastric cancer based on histology, genetic and proteomic alterations has evolved. It provides a roadmap for development of new drugs and combinations and for patient stratification. Anti-HER2 treatment, which is an effective strategy in metastatic gastric cancer, is now also being studied in the perioperative setting. However, resistance mechanisms in advanced disease are poorly understood and optimal patient selection remains challenging. Targeting angiogenesis is an emerging concept in the management of advanced gastric cancer, and ramucirumab has prolonged survival in the second line either as a monotherapy or in combination with paclitaxel. Biomarkers for selecting patients who benefit from ramucirumab are still lacking. Immune checkpoint blockade and inhibition of cancer stemness targets are other emerging directions for the medical treatment of gastric cancer. Large-scale international studies are ongoing. Promising biology-based treatment strategies are evolving. But tumor heterogeneity which is an inherent feature of gastric cancer challenges the development of molecularly targeted and personalized treatment strategies.

Recent Advances towards the Clinical Application of Stem Cells for Retinal Regeneration

PubMed Central

Becker, Silke; Jayaram, Hari; Limb, G. Astrid

2012-01-01

Retinal degenerative diseases constitute a major cause of irreversible blindness in the world. Stem cell-based therapies offer hope for these patients at risk of or suffering from blindness due to the deterioration of the neural retina. Various sources of stem cells are currently being investigated, ranging from human embryonic stem cells to adult-derived induced pluripotent stem cells as well as human Müller stem cells, with the first clinical trials to investigate the safety and tolerability of human embryonic stem cell-derived retinal pigment epithelium cells having recently commenced. This review aims to summarize the latest advances in the development of stem cell strategies for the replacement of retinal neurons and their supportive cells, the retinal pigment epithelium (RPE) affected by retinal degenerative conditions. Particular emphasis will be given to the advances in stem cell transplantation and the challenges associated with their translation into clinical practice. PMID:24710533

Regulatory considerations for clinical development of cancer vaccines.

PubMed

Heelan, Bridget Theresa

2014-01-01

Cancer vaccines are aimed at stimulating an immune response to tumor tissue. There is a high level of clinical activity in this rapidly advancing field with over 1,400 trials registered on Clincaltrials.gov. The recent approval of Sipuleucel-T which is the first cancer vaccine approved in the US and EU has encouraged developers in this field. In contrast to more established approaches for treating cancer such as chemotherapy, regulatory guidelines have been developed relatively recently for cancer vaccines. These guidelines advise on general clinical requirements. As there is an increase in innovative strategies with novel products, a 2-way dialog with regulators is recommended on a case-by-case basis to justify the clinical development plan, taking into account specific quality issues related to the product(s) in development. It is important that the rationale, background and justification for the planned development is convincing when interacting with the regulatory authorities, to enable drug developers and regulators to reach agreement.

Personhood, patienthood, and clinical practice: reassessing advance directives.

PubMed

Rich, B A

1998-09-01

This article considers 2 major critiques of advance directives and offers a defense to each of them. The 1st critique is philosophical in nature and maintains that the moral authority of an advance directive is undercut by a failure of personal identity to survive the loss of decisional capacity. The response in this article is that this critique relies on a flawed and disfavored concept of persons and their persistence over time. The 2nd critique, pragmatic in nature, argues that advance directives cannot be authoritative because the requisite elements of an informed consent to or refusal of treatment are rarely present, and many such instruments are ambiguous. The author argues that if the creation of advance directives, as a form of advance care planning, is made an integral aspect of clinical practice, many more patients will elect to execute directives, and those directives will not be ambiguous.

Advances in the delivery of RNA therapeutics: from concept to clinical reality.

PubMed

Kaczmarek, James C; Kowalski, Piotr S; Anderson, Daniel G

2017-06-27

The rapid expansion of the available genomic data continues to greatly impact biomedical science and medicine. Fulfilling the clinical potential of genetic discoveries requires the development of therapeutics that can specifically modulate the expression of disease-relevant genes. RNA-based drugs, including short interfering RNAs and antisense oligonucleotides, are particularly promising examples of this newer class of biologics. For over two decades, researchers have been trying to overcome major challenges for utilizing such RNAs in a therapeutic context, including intracellular delivery, stability, and immune response activation. This research is finally beginning to bear fruit as the first RNA drugs gain FDA approval and more advance to the final phases of clinical trials. Furthermore, the recent advent of CRISPR, an RNA-guided gene-editing technology, as well as new strides in the delivery of messenger RNA transcribed in vitro, have triggered a major expansion of the RNA-therapeutics field. In this review, we discuss the challenges for clinical translation of RNA-based therapeutics, with an emphasis on recent advances in delivery technologies, and present an overview of the applications of RNA-based drugs for modulation of gene/protein expression and genome editing that are currently being investigated both in the laboratory as well as in the clinic.

Developing a clinical trial unit to advance research in an academic institution.

PubMed

Croghan, Ivana T; Viker, Steven D; Limper, Andrew H; Evans, Tamara K; Cornell, Alissa R; Ebbert, Jon O; Gertz, Morie A

2015-11-01

Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trial unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine clinical trial unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a central unit to provide research support in clinical trials and presents the advantages, disadvantages, and required building blocks for such a unit. Copyright © 2015 Mayo Clinic. Published by Elsevier Inc. All rights reserved.

TBVAC2020: Advancing Tuberculosis Vaccines from Discovery to Clinical Development.

PubMed

Kaufmann, Stefan H E; Dockrell, Hazel M; Drager, Nick; Ho, Mei Mei; McShane, Helen; Neyrolles, Olivier; Ottenhoff, Tom H M; Patel, Brij; Roordink, Danielle; Spertini, François; Stenger, Steffen; Thole, Jelle; Verreck, Frank A W; Williams, Ann

2017-01-01

TBVAC2020 is a research project supported by the Horizon 2020 program of the European Commission (EC). It aims at the discovery and development of novel tuberculosis (TB) vaccines from preclinical research projects to early clinical assessment. The project builds on previous collaborations from 1998 onwards funded through the EC framework programs FP5, FP6, and FP7. It has succeeded in attracting new partners from outstanding laboratories from all over the world, now totaling 40 institutions. Next to the development of novel vaccines, TB biomarker development is also considered an important asset to facilitate rational vaccine selection and development. In addition, TBVAC2020 offers portfolio management that provides selection criteria for entry, gating, and priority settings of novel vaccines at an early developmental stage. The TBVAC2020 consortium coordinated by TBVI facilitates collaboration and early data sharing between partners with the common aim of working toward the development of an effective TB vaccine. Close links with funders and other consortia with shared interests further contribute to this goal.

TBVAC2020: Advancing Tuberculosis Vaccines from Discovery to Clinical Development

PubMed Central

Kaufmann, Stefan H. E.; Dockrell, Hazel M.; Drager, Nick; Ho, Mei Mei; McShane, Helen; Neyrolles, Olivier; Ottenhoff, Tom H. M.; Patel, Brij; Roordink, Danielle; Spertini, François; Stenger, Steffen; Thole, Jelle; Verreck, Frank A. W.; Williams, Ann; Britton, Warwick

2017-01-01

TBVAC2020 is a research project supported by the Horizon 2020 program of the European Commission (EC). It aims at the discovery and development of novel tuberculosis (TB) vaccines from preclinical research projects to early clinical assessment. The project builds on previous collaborations from 1998 onwards funded through the EC framework programs FP5, FP6, and FP7. It has succeeded in attracting new partners from outstanding laboratories from all over the world, now totaling 40 institutions. Next to the development of novel vaccines, TB biomarker development is also considered an important asset to facilitate rational vaccine selection and development. In addition, TBVAC2020 offers portfolio management that provides selection criteria for entry, gating, and priority settings of novel vaccines at an early developmental stage. The TBVAC2020 consortium coordinated by TBVI facilitates collaboration and early data sharing between partners with the common aim of working toward the development of an effective TB vaccine. Close links with funders and other consortia with shared interests further contribute to this goal. PMID:29046674

Clinical benefit of antiangiogenic therapy in advanced and metastatic chondrosarcoma.

PubMed

Jones, Robin L; Katz, Daniela; Loggers, Elizabeth T; Davidson, Darin; Rodler, Eve T; Pollack, Seth M

2017-08-29

Chondrosarcoma is the most common bone sarcoma in adults. Conventional chondrosarcoma, the commonest histological subtype, is largely resistant to anthracycline-based chemotherapy. There have been anecdotal reports of durable clinical benefit with antiangiogenic agents in this disease. A retrospective search of patients treated at three sarcoma referral centers was performed to identify patients with advanced chondrosarcoma treated with antiangiogenic agents. The aim of this study was to evaluate the efficacy and safety of antiangiogenic agents in advanced chondrosarcoma. Ten patients were identified; seven with conventional, one each with clear cell, extraskeletal mesenchymal chondrosarcoma and extraskeletal myxoid chondrosarcoma. The median progression-free survival for patients with conventional and clear cell sarcoma was 22.6 months. Median overall survival has not been met. Antiangiogenic therapy was well tolerated in this series of patients. Our retrospective data suggest that antiangiogenic therapy can provide prolonged clinical benefit in advanced chondrosarcoma patients. Further prospective trials are required to precisely define the role of this class of agent in advanced chondrosarcoma.

Recent advances in (therapeutic protein) drug development

PubMed Central

Lagassé, H.A. Daniel; Alexaki, Aikaterini; Simhadri, Vijaya L.; Katagiri, Nobuko H.; Jankowski, Wojciech; Sauna, Zuben E.; Kimchi-Sarfaty, Chava

2017-01-01

Therapeutic protein drugs are an important class of medicines serving patients most in need of novel therapies. Recently approved recombinant protein therapeutics have been developed to treat a wide variety of clinical indications, including cancers, autoimmunity/inflammation, exposure to infectious agents, and genetic disorders. The latest advances in protein-engineering technologies have allowed drug developers and manufacturers to fine-tune and exploit desirable functional characteristics of proteins of interest while maintaining (and in some cases enhancing) product safety or efficacy or both. In this review, we highlight the emerging trends and approaches in protein drug development by using examples of therapeutic proteins approved by the U.S. Food and Drug Administration over the previous five years (2011–2016, namely January 1, 2011, through August 31, 2016). PMID:28232867

Biology of advanced uveal melanoma and next steps for clinical therapeutics.

PubMed

Luke, Jason J; Triozzi, Pierre L; McKenna, Kyle C; Van Meir, Erwin G; Gershenwald, Jeffrey E; Bastian, Boris C; Gutkind, J Silvio; Bowcock, Anne M; Streicher, Howard Z; Patel, Poulam M; Sato, Takami; Sossman, Jeffery A; Sznol, Mario; Welch, Jack; Thurin, Magdalena; Selig, Sara; Flaherty, Keith T; Carvajal, Richard D

2015-03-01

Uveal melanoma is the most common intraocular malignancy although it is a rare subset of all melanomas. Uveal melanoma has distinct biology relative to cutaneous melanoma, with widely divergent patient outcomes. Patients diagnosed with a primary uveal melanoma can be stratified for risk of metastasis by cytogenetics or gene expression profiling, with approximately half of patients developing metastatic disease, predominately hepatic in location, over a 15-yr period. Historically, no systemic therapy has been associated with a clear clinical benefit for patients with advanced disease, and median survival remains poor. Here, as a joint effort between the Melanoma Research Foundation's ocular melanoma initiative, CURE OM and the National Cancer Institute, the current understanding of the molecular and immunobiology of uveal melanoma is reviewed, and on-going laboratory research into the disease is highlighted. Finally, recent investigations relevant to clinical management via targeted and immunotherapies are reviewed, and next steps in the development of clinical therapeutics are discussed. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Advancement of the Artificial Pancreas through the Development of Interoperability Standards

PubMed Central

Picton, Peter E.; Yeung, Melanie; Hamming, Nathaniel; Desborough, Lane; Dassau, Eyal; Cafazzo, Joseph A.

2013-01-01

Despite advancements in the development of the artificial pancreas, barriers in the form of proprietary data and communication protocols of diabetes devices have made the integration of these components challenging. The Artificial Pancreas Standards and Technical Platform Project is an initiative funded by the JDRF Canadian Clinical Trial Network with the goal of developing device communication standards for the interoperability of diabetes devices. Stakeholders from academia, industry, regulatory agencies, and medical and patient communities have been engaged in advancing this effort. In this article, we describe this initiative along with the process involved in working with the standards organizations and stakeholders that are key to ensuring effective standards are developed and adopted. Discussion from a special session of the 12th Annual Diabetes Technology Meeting is also provided. PMID:23911190

Advances and challenges in malaria vaccine development.

PubMed

Crompton, Peter D; Pierce, Susan K; Miller, Louis H

2010-12-01

Malaria caused by Plasmodium falciparum remains a major public health threat, especially among children and pregnant women in Africa. An effective malaria vaccine would be a valuable tool to reduce the disease burden and could contribute to elimination of malaria in some regions of the world. Current malaria vaccine candidates are directed against human and mosquito stages of the parasite life cycle, but thus far, relatively few proteins have been studied for potential vaccine development. The most advanced vaccine candidate, RTS,S, conferred partial protection against malaria in phase II clinical trials and is currently being evaluated in a phase III trial in Africa. New vaccine targets need to be identified to improve the chances of developing a highly effective malaria vaccine. A better understanding of the mechanisms of naturally acquired immunity to malaria may lead to insights for vaccine development.

Advanced adaptive optics technology development

NASA Astrophysics Data System (ADS)

Olivier, Scot S.

2002-02-01

The NSF Center for Adaptive Optics (CfAO) is supporting research on advanced adaptive optics technologies. CfAO research activities include development and characterization of micro-electro-mechanical systems (MEMS) deformable mirror (DM) technology, as well as development and characterization of high-resolution adaptive optics systems using liquid crystal (LC) spatial light modulator (SLM) technology. This paper presents an overview of the CfAO advanced adaptive optics technology development activities including current status and future plans.

Energy Storage (II): Developing Advanced Technologies

ERIC Educational Resources Information Center

Robinson, Arthur L

1974-01-01

Energy storage, considered by some scientists to be the best technological and economic advancement after advanced nuclear power, still rates only modest funding for research concerning the development of advanced technologies. (PEB)

World Workshop on Oral Medicine VI: an international validation study of clinical competencies for advanced training in oral medicine.

PubMed

Steele, John C; Clark, Hadleigh J; Hong, Catherine H L; Jurge, Sabine; Muthukrishnan, Arvind; Kerr, A Ross; Wray, David; Prescott-Clements, Linda; Felix, David H; Sollecito, Thomas P

2015-08-01

To explore international consensus for the validation of clinical competencies for advanced training in Oral Medicine. An electronic survey of clinical competencies was designed. The survey was sent to and completed by identified international stakeholders during a 10-week period. To be validated, an individual competency had to achieve 90% or greater consensus to keep it in its current format. Stakeholders from 31 countries responded. High consensus agreement was achieved with 93 of 101 (92%) competencies exceeding the benchmark for agreement. Only 8 warranted further attention and were reviewed by a focus group. No additional competencies were suggested. This is the first international validated study of clinical competencies for advanced training in Oral Medicine. These validated clinical competencies could provide a model for countries developing an advanced training curriculum for Oral Medicine and also inform review of existing curricula. Copyright © 2015 Elsevier Inc. All rights reserved.

Changing the Face of Veterinary Medicine: Research and Clinical Developments at AAVMC Institutions.

PubMed

Smith, Donald F; Hagstrom, Melena R

2015-01-01

This paper provides a 50-year overview of research and clinical advances in AAVMC member colleges in four representative fields of veterinary medicine: oncology, vaccine development, production medicine, and public health. Though emphasis is on the progress since the mid-1960s, the salient background and associated personnel in each field are also identified to the extent that their description informs more recent events. Advances in board certification and post-graduate clinical and research educational opportunities are also described.

Clinically relevant advances in on-chip affinity-based electrophoresis and electrochromatography.

PubMed

Hou, Chenlu; Herr, Amy E

2008-08-01

Clinical and point-of-care disease diagnostics promise to play an important role in personalized medicine, new approaches to global health, and health monitoring. Emerging instrument platforms based on lab-on-a-chip technology can confer performance advantages successfully exploited in electrophoresis and electrochromatography to affinity-based electrokinetic separations. This review surveys lab-on-a-chip diagnostic developments in affinity-based electrokinetic separations for quantitation of proteins, integration of preparatory functions needed for subsequent analysis of diverse biological samples, and initial forays into multiplexed analyses. The technologies detailed here underpin new clinical and point-of-care diagnostic strategies. The techniques and devices promise to advance translation of until now laboratory-based sample preparation and analytical assays to near-patient settings.

The development of advanced nursing practice globally.

PubMed

Sheer, Barbara; Wong, Frances Kam Yuet

2008-01-01

To examine the development of advanced nursing practice globally. Data were collected from documentary resources available in the International Nurse Practitioners/Advanced Practice Nurse Network (INP/APNN) of the International Council of Nurses. The areas examined were guided by the "key informant survey on advanced nursing practice self-administered questionnaire." Two core members of the INP/APNN who have rich experience in global advanced nursing development analyzed the data.A total of 14 countries and three regions from five continents were included in the analyses. The development of advanced nursing practice in these areas is facilitated by a need for better access to care in a cost-containment era and the enhancement of nursing education to postgraduate level. The mechanism for regulation of practice is in place in some countries. Confirms the development of advanced practice in nursing is a global trend. APNs can improve global health with points to enhanced education in nursing and regulation of advanced practice.

Advances in clinical immunology in 2015.

PubMed

Chinen, Javier; Notarangelo, Luigi D; Shearer, William T

2016-12-01

Advances in clinical immunology in the past year included the report of practice parameters for the diagnosis and management of primary immunodeficiencies to guide the clinician in the approach to these relatively uncommon disorders. We have learned of new gene defects causing immunodeficiency and of new phenotypes expanding the spectrum of conditions caused by genetic mutations such as a specific regulator of telomere elongation (RTEL1) mutation causing isolated natural killer cell deficiency and mutations in ras-associated RAB (RAB27) resulting in immunodeficiency without albinism. Advances in diagnosis included the increasing use of whole-exome sequencing to identify gene defects and the measurement of serum free light chains to identify secondary hypogammaglobulinemias. For several primary immunodeficiencies, improved outcomes have been reported after definitive therapy with hematopoietic stem cell transplantation and gene therapy. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Advances in quantitative UV-visible spectroscopy for clinical and pre-clinical application in cancer.

PubMed

Brown, J Quincy; Vishwanath, Karthik; Palmer, Gregory M; Ramanujam, Nirmala

2009-02-01

Methods of optical spectroscopy that provide quantitative, physically or physiologically meaningful measures of tissue properties are an attractive tool for the study, diagnosis, prognosis, and treatment of various cancers. Recent development of methodologies to convert measured reflectance and fluorescence spectra from tissue to cancer-relevant parameters such as vascular volume, oxygenation, extracellular matrix extent, metabolic redox states, and cellular proliferation have significantly advanced the field of tissue optical spectroscopy. The number of publications reporting quantitative tissue spectroscopy results in the UV-visible wavelength range has increased sharply in the past three years, and includes new and emerging studies that correlate optically measured parameters with independent measures such as immunohistochemistry, which should aid in increased clinical acceptance of these technologies.

Development of a video-based education and process change intervention to improve advance cardiopulmonary resuscitation decision-making.

PubMed

Waldron, Nicholas; Johnson, Claire E; Saul, Peter; Waldron, Heidi; Chong, Jeffrey C; Hill, Anne-Marie; Hayes, Barbara

2016-10-06

Advance cardiopulmonary resuscitation (CPR) decision-making and escalation of care discussions are variable in routine clinical practice. We aimed to explore physician barriers to advance CPR decision-making in an inpatient hospital setting and develop a pragmatic intervention to support clinicians to undertake and document routine advance care planning discussions. Two focus groups, which involved eight consultants and ten junior doctors, were conducted following a review of the current literature. A subsequent iterative consensus process developed two intervention elements: (i) an updated 'Goals of Patient Care' (GOPC) form and process; (ii) an education video and resources for teaching advance CPR decision-making and communication. A multidisciplinary group of health professionals and policy-makers with experience in systems development, education and research provided critical feedback. Three key themes emerged from the focus groups and the literature, which identified a structure for the intervention: (i) knowing what to say; (ii) knowing how to say it; (iii) wanting to say it. The themes informed the development of a video to provide education about advance CPR decision-making framework, improving communication and contextualising relevant clinical issues. Critical feedback assisted in refining the video and further guided development and evolution of a medical GOPC approach to discussing and recording medical treatment and advance care plans. Through an iterative process of consultation and review, video-based education and an expanded GOPC form and approach were developed to address physician and systemic barriers to advance CPR decision-making and documentation. Implementation and evaluation across hospital settings is required to examine utility and determine effect on quality of care.

Construction of databases: advances and significance in clinical research.

PubMed

Long, Erping; Huang, Bingjie; Wang, Liming; Lin, Xiaoyu; Lin, Haotian

2015-12-01

Widely used in clinical research, the database is a new type of data management automation technology and the most efficient tool for data management. In this article, we first explain some basic concepts, such as the definition, classification, and establishment of databases. Afterward, the workflow for establishing databases, inputting data, verifying data, and managing databases is presented. Meanwhile, by discussing the application of databases in clinical research, we illuminate the important role of databases in clinical research practice. Lastly, we introduce the reanalysis of randomized controlled trials (RCTs) and cloud computing techniques, showing the most recent advancements of databases in clinical research.

Implications of pharmacogenomics for drug development and clinical practice.

PubMed

Ginsburg, Geoffrey S; Konstance, Richard P; Allsbrook, Jennifer S; Schulman, Kevin A

2005-11-14

Pharmacogenomics is likely to be among the first clinical applications of the Human Genome Project and is certain to have an enormous impact on the clinical practice of medicine. Herein, we discuss the potential implications of pharmacogenomics on the drug development process, including drug safety, productivity, market segmentation, market expansion, differentiation, and personalized health care. We also review 3 challenges facing the translation of pharmacogenomics into clinical practice: dependence on information technology, limited health care financing, and the scientific uncertainty surrounding validation of specific applications of the technology. To our knowledge, there is currently no formal agenda to promote and cultivate innovation, to develop progressive information technology, or to obtain the financing that would be required to advance the use of pharmacogenomic technologies in patient care. Although the potential of these technologies is driving change in the development of clinical sciences, it remains to be seen which health care systems level needs will be addressed.

[Image guided and robotic treatment--the advance of cybernetics in clinical medicine].

PubMed

Fosse, E; Elle, O J; Samset, E; Johansen, M; Røtnes, J S; Tønnessen, T I; Edwin, B

2000-01-10

The introduction of advanced technology in hospitals has changed the treatment practice towards more image guided and minimal invasive procedures. Modern computer and communication technology opens up for robot aided and pre-programmed intervention. Several robotic systems are in clinical use today both in microsurgery and in major cardiac and orthopedic operations. As this trend develops, professions which are new in this context such as physicists, mathematicians and cybernetic engineers will be increasingly important in the treatment of patients.

Clinical software development for the Web: lessons learned from the BOADICEA project.

PubMed

Cunningham, Alex P; Antoniou, Antonis C; Easton, Douglas F

2012-04-10

In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web

Clinical software development for the Web: lessons learned from the BOADICEA project

PubMed Central

2012-01-01

Background In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. Results We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers

Training and career development in clinical and translational science: an opportunity for rehabilitation scientists.

PubMed

Kelly, Thomas H; Mattacola, Carl G

2010-11-01

The National Institutes of Health's Clinical and Translational Science Award initiative is designed to establish and promote academic centers of clinical and translational science (CTS) that are empowered to train and advance multi- and interdisciplinary investigators and research teams to apply new scientific knowledge and techniques to enhance patient care. Among the key components of a full-service center for CTS is an educational platform to support research training in CTS. Educational objectives and resources available to support the career development of the clinical and translational scientists, including clinical research education, mentored research training, and career development support, are described. The purpose of the article is to provide an overview of the CTS educational model so that rehabilitation specialists can become more aware of potential resources that are available and become more involved in the delivery and initiation of the CTS model in their own workplace. Rehabilitation clinicians and scientists are well positioned to play important leadership roles in advancing the academic mission of CTS. Rigorous academic training in rehabilitation science serves as an effective foundation for supporting the translation of basic scientific discovery into improved health care. Rehabilitation professionals are immersed in patient care, familiar with interdisciplinary health care delivery, and skilled at working with multiple health care professionals. The NIH Clinical and Translational Science Award initiative is an excellent opportunity to advance the academic development of rehabilitation scientists.

Advanced Learning Theories Applied to Leadership Development

DTIC Science & Technology

2006-11-01

Theory . We combined the cognitive , experiential and motivational components of advanced learning theories to develop a training application...Center for Army Leadership Technical Report 2006-2 Advanced Learning Theories Applied to Leadership Development Christina Curnow...2006 5a. CONTRACT NUMBER W91QF4-05-F-0026 5b. GRANT NUMBER 4. TITLE AND SUBTITLE Advanced Learning Theories Applied to Leadership Development 5c

Multiscale Modeling in the Clinic: Drug Design and Development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Clancy, Colleen E.; An, Gary; Cannon, William R.

A wide range of length and time scales are relevant to pharmacology, especially in drug development, drug design and drug delivery. Therefore, multi-scale computational modeling and simulation methods and paradigms that advance the linkage of phenomena occurring at these multiple scales have become increasingly important. Multi-scale approaches present in silico opportunities to advance laboratory research to bedside clinical applications in pharmaceuticals research. This is achievable through the capability of modeling to reveal phenomena occurring across multiple spatial and temporal scales, which are not otherwise readily accessible to experimentation. The resultant models, when validated, are capable of making testable predictions tomore » guide drug design and delivery. In this review we describe the goals, methods, and opportunities of multi-scale modeling in drug design and development. We demonstrate the impact of multiple scales of modeling in this field. We indicate the common mathematical techniques employed for multi-scale modeling approaches used in pharmacology and present several examples illustrating the current state-of-the-art regarding drug development for: Excitable Systems (Heart); Cancer (Metastasis and Differentiation); Cancer (Angiogenesis and Drug Targeting); Metabolic Disorders; and Inflammation and Sepsis. We conclude with a focus on barriers to successful clinical translation of drug development, drug design and drug delivery multi-scale models.« less

Ten years of iPSC: clinical potential and advances in vitro hematopoietic differentiation.

PubMed

Paes, Bárbara Cristina Martins Fernandes; Moço, Pablo Diego; Pereira, Cristiano Gonçalves; Porto, Geciane Silveira; de Sousa Russo, Elisa Maria; Reis, Luiza Cunha Junqueira; Covas, Dimas Tadeu; Picanço-Castro, Virginia

2017-06-01

Ten years have passed since the first publication announcing the generation of induced pluripotent stem cells (iPSCs). Issues related to ethics, immune rejection, and cell availability seemed to be solved following this breakthrough. The development of iPSC technology allows advances in in vitro cell differentiation for cell therapy purpose and other clinical applications. This review provides a perspective on the iPSC potential for cell therapies, particularly for hematological applications. We discuss the advances in in vitro hematopoietic differentiation, the possibilities to employ iPSC in hematology studies, and their potential clinical application in hematologic diseases. The generation of red blood cells and functional T cells and the genome editing technology applied to mutation correction are also covered. We highlight some of the requirements and obstacles to be overcome before translating these cells from research to the clinic, for instance, iPSC variability, genotoxicity, the differentiation process, and engraftment. Also, we evaluate the patent landscape and compile the clinical trials in the field of pluripotent stem cells. Currently, we know much more about iPSC than in 2006, but there are still challenges that must be solved. A greater understanding of molecular mechanisms underlying the generation of hematopoietic stem cells is necessary to produce suitable and transplantable hematopoietic stem progenitor cells from iPSC.

Clinical Implementation of Novel Targeted Therapeutics in Advanced Breast Cancer.

PubMed

Chamberlin, Mary D; Bernhardt, Erica B; Miller, Todd W

2016-11-01

The majority of advanced breast cancers have genetic alterations that are potentially targetable with drugs. Through initiatives such as The Cancer Genome Atlas (TCGA) and the International Cancer Genome Consortium (ICGC), data can be mined to provide context for next-generation sequencing (NGS) results in the landscape of advanced breast cancer. Therapies for targets other than estrogen receptor alpha (ER) and HER2, such as cyclin-dependent kinases CDK4 and CDK6, were recently approved based on efficacy in patient subpopulations, but no predictive biomarkers have been found, leaving clinicians to continue a trial-and-error approach with each patient. Next-generation sequencing identifies potentially actionable alterations in genes thought to be drivers in the cancerous process including phosphatidylinositol 3-kinase (PI3K), AKT, fibroblast growth factor receptors (FGFRs), and mutant HER2. Epigenetically directed and immunologic therapies have also shown promise for the treatment of breast cancer via histone deacetylases (HDAC) 1 and 3, programmed T cell death 1 (PD-1), and programmed T cell death ligand 1 (PD-L1). Identifying biomarkers to predict primary resistance in breast cancer will ultimately affect clinical decisions regarding adjuvant therapy in the first-line setting. However, the bulk of medical decision-making is currently made in the secondary resistance setting. Herein, we review the clinical potential of PI3K, AKT, FGFRs, mutant HER2, HDAC1/3, PD-1, and PD-L1 as therapeutic targets in breast cancer, focusing on the rationale for therapeutic development and the status of clinical testing. J. Cell. Biochem. 117: 2454-2463, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Clinical Cancer Advances 2018: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology.

PubMed

Heymach, John; Krilov, Lada; Alberg, Anthony; Baxter, Nancy; Chang, Susan Marina; Corcoran, Ryan; Dale, William; DeMichele, Angela; Magid Diefenbach, Catherine S; Dreicer, Robert; Epstein, Andrew S; Gillison, Maura L; Graham, David L; Jones, Joshua; Ko, Andrew H; Lopez, Ana Maria; Maki, Robert G; Rodriguez-Galindo, Carlos; Schilsky, Richard L; Sznol, Mario; Westin, Shannon Neville; Burstein, Harold

2018-04-01

A MESSAGE FROM ASCO'S PRESIDENT I remember when ASCO first conceived of publishing an annual report on the most transformative research occurring in cancer care. Thirteen reports later, the progress we have chronicled is remarkable, and this year is no different. The research featured in ASCO's Clinical Cancer Advances 2018 report underscores the impressive gains in our understanding of cancer and in our ability to tailor treatments to tumors' genetic makeup. The ASCO 2018 Advance of the Year, adoptive cell immunotherapy, allows clinicians to genetically reprogram patients' own immune cells to find and attack cancer cells throughout the body. Chimeric antigen receptor (CAR) T-cell therapy-a type of adoptive cell immunotherapy-has led to remarkable results in young patients with acute lymphoblastic leukemia (ALL) and in adults with lymphoma and multiple myeloma. Researchers are also exploring this approach in other types of cancer. This advance would not be possible without robust federal investment in cancer research. The first clinical trial of CAR T-cell therapy in children with ALL was funded, in part, by grants from the National Cancer Institute (NCI), and researchers at the NCI Center for Cancer Research were the first to report on possible CAR T-cell therapy for multiple myeloma. These discoveries follow decades of prior research on immunology and cancer biology, much of which was supported by federal dollars. In fact, many advances that are highlighted in the 2018 Clinical Cancer Advances report were made possible thanks to our nation's support for biomedical research. Funding from the US National Institutes of Health and the NCI helps researchers pursue critical patient care questions and addresses vital, unmet needs that private industry has little incentive to take on. Federally supported cancer research generates the biomedical innovations that fuel the development and availability of new and improved treatments for patients. We need sustained federal

Clinical and radiographic evaluation of maxillary central incisors exposure in patients undergoing maxillary advancement

PubMed Central

Trento, Guilherme dos Santos; Bernabé, Felipe Bueno Rosettti; da Costa, Delson João; Rebellato, Nelson Luis Barbosa; Klüppel, Leandro Eduardo; Scariot, Rafaela

2015-01-01

Abstract Introduction: Patients with dentofacial deformities may undergo orthodontic or orthodontic-surgical treatment. Both modalities can affect esthetics. Objective: This study aims to evaluate clinical and radiographic changes in exposure of maxillary central incisors occurring after orthognathic surgery for maxillary advancement. Methods: A total of 17 patients who underwent orthognathic surgery for maxillary advancement between September, 2010 and July, 2011 were selected. Exposure of maxillary central incisors was evaluated clinically and by lateral cephalograms. Measurements were taken one week before and three months after surgery. Data were paired in terms of sex, age, nasolabial angle, height and thickness of the upper lip, the amount of maxillary advancement, clinical exposure and inclination of maxillary central incisor by statistical tests (CI 95%). Results: After maxillary advancement, incisor clinical exposure had increased even with relaxed lips and under forced smile. Moreover, there was a mean increase of 23.33% revealed by lateral cephalograms. There was an inverse correlation between upper lip thickness and incisors postsurgical exposure revealed by radiographic images (p = 0.002). Conclusions: Significant changes in the exposure of maxillary central incisors occur after maxillary advancement, under the influence of some factors, especially lip thickness. PMID:26691970

Advances in mass spectrometry-based cancer research and analysis: from cancer proteomics to clinical diagnostics.

PubMed

Timms, John F; Hale, Oliver J; Cramer, Rainer

2016-06-01

The last 20 years have seen significant improvements in the analytical capabilities of biological mass spectrometry (MS). Studies using advanced MS have resulted in new insights into cell biology and the etiology of diseases as well as its use in clinical applications. This review discusses recent developments in MS-based technologies and their cancer-related applications with a focus on proteomics. It also discusses the issues around translating the research findings to the clinic and provides an outline of where the field is moving. Expert commentary: Proteomics has been problematic to adapt for the clinical setting. However, MS-based techniques continue to demonstrate potential in novel clinical uses beyond classical cancer proteomics.

Data management system advanced development

NASA Technical Reports Server (NTRS)

Douglas, Katherine; Humphries, Terry

1990-01-01

The Data Management System (DMS) Advanced Development task provides for the development of concepts, new tools, DMS services, and for the testing of the Space Station DMS hardware and software. It also provides for the development of techniques capable of determining the effects of system changes/enhancements, additions of new technology, and/or hardware and software growth on system performance. This paper will address the built-in characteristics which will support network monitoring requirements in the design of the evolving DMS network implementation, functional and performance requirements for a real-time, multiprogramming, multiprocessor operating system, and the possible use of advanced development techniques such as expert systems and artificial intelligence tools in the DMS design.

Clinical skills assessment of procedural and advanced communication skills: performance expectations of residency program directors.

PubMed

Langenau, Erik E; Zhang, Xiuyuan; Roberts, William L; DeChamplain, Andre F; Boulet, John R

2012-01-01

High stakes medical licensing programs are planning to augment and adapt current examinations to be relevant for a two-decision point model for licensure: entry into supervised practice and entry into unsupervised practice. Therefore, identifying which skills should be assessed at each decision point is critical for informing examination development, and gathering input from residency program directors is important. Using data from previously developed surveys and expert panels, a web-delivered survey was distributed to 3,443 residency program directors. For each of the 28 procedural and 18 advanced communication skills, program directors were asked which clinical skills should be assessed, by whom, when, and how. Descriptive statistics were collected, and Intraclass Correlations (ICC) were conducted to determine consistency across different specialties. Among 347 respondents, program directors reported that all advanced communication and some procedural tasks are important to assess. The following procedures were considered 'important' or 'extremely important' to assess: sterile technique (93.8%), advanced cardiovascular life support (ACLS) (91.1%), basic life support (BLS) (90.0%), interpretation of electrocardiogram (89.4%) and blood gas (88.7%). Program directors reported that most clinical skills should be assessed at the end of the first year of residency (or later) and not before graduation from medical school. A minority were considered important to assess prior to the start of residency training: demonstration of respectfulness (64%), sterile technique (67.2%), BLS (68.9%), ACLS (65.9%) and phlebotomy (63.5%). Results from this study support that assessing procedural skills such as cardiac resuscitation, sterile technique, and phlebotomy would be amenable to assessment at the end of medical school, but most procedural and advanced communications skills would be amenable to assessment at the end of the first year of residency training or later. Gathering

Building Bridges: Leveraging Interdisciplinary Collaborations in the Development of Biomaterials to Meet Clinical Needs

PubMed Central

Fong, Eliza L.S.; Watson, Brendan M.; Kasper, F. Kurtis

2013-01-01

Our laboratory at Rice University has forged numerous collaborations with clinicians and basic scientists over the years to advance the development of novel biomaterials and modification of existing materials to meet clinical needs. This review highlights collaborative advances in biomaterials research from our laboratory in the areas of scaffold development, drug delivery and gene therapy, especially as related to applications in bone and cartilage tissue engineering. PMID:22821772

Advances in basic and clinical immunology in 2016.

PubMed

Chinen, Javier; Badran, Yousef R; Geha, Raif S; Chou, Janet S; Fried, Ari J

2017-10-01

Advances in basic immunology in 2016 included studies that further characterized the role of different proteins in the differentiation of effector T and B cells, including cytokines and proteins involved in the actin cytoskeleton. Regulation of granule formation and secretion in cytotoxic cells was also further described by examining patients with familial hemophagocytic lymphohistiocytosis. The role of prenylation in patients with mevalonate kinase deficiency leading to inflammation has been established. We reviewed advances in clinical immunology, as well as new approaches of whole-genome sequencing and genes newly reported to be associated with immunodeficiency, such as linker of activation of T cells (LAT); B-cell CLL/lymphoma 11B (BCL11B); RGD, leucine-rich repeat, tropomodulin domain, and proline-rich domain-containing protein (RLTPR); moesin; and Janus kinase 1 (JAK1). Trials of hematopoietic stem cell transplantation and gene therapy for primary immunodeficiency have had relative success; the use of autologous virus-specific cytotoxic T cells has proved effective as well. New medications are being explored, such as pioglitazone, which is under study for its role in enhancing the oxidative burst in patients with chronic granulomatous disease. Development of vaccines for HIV infection continues to provide insight into the immune response against a virus with an extraordinary mutation rate. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

A multidisciplinary prostate cancer clinic for newly diagnosed patients: developing the role of the advanced practice nurse.

PubMed

Madsen, Lydia T; Craig, Catherine; Kuban, Deborah

2009-06-01

Newly diagnosed patients with prostate cancer have various treatment options, and a multidisciplinary prostate cancer clinic (MPCC) can present all options in a single setting. An MPCC was started in 2004 at the University of Texas M.D. Anderson Cancer Center, and 258 patients with prostate cancer were evaluated in its first year. The clinic expanded in 2006 and an oncology advanced practice nurse (APN) was recruited to address specific objectives. The APN role was used to implement a quality-of-life protocol, provide detailed patient education (including a treatment summary and care plan), and serve as a single point of contact as patients move toward a treatment decision. Formal evaluation of the MPCC showed that patients were satisfied with this approach to the complex decision-making process in prostate cancer.

Lost in Translation: The Unintended Consequences of Advance Directive Law on Clinical Care

PubMed Central

Castillo, Lesley S.; Williams, Brie A.; Hooper, Sarah M.; Sabatino, Charles P.; Weithorn, Lois A.; Sudore, Rebecca L.

2011-01-01

Background Advance directive law may compromise the clinical effectiveness of advance directives. Purpose To identify unintended legal consequences of advance directive law that may prevent patients from communicating end-of-life preferences. Data Sources Advance directive legal statutes for all 50 U.S. states and the District of Columbia and English-language searches of LexisNexis, Westlaw, and MEDLINE from 1966 to August 2010. Study Selection Two independent reviewers selected 51 advance directive statutes and 20 articles. Three independent legal reviewers selected 105 legal proceedings. Data Extraction Two reviewers independently assessed data sources and used critical content analysis to determine legal barriers to the clinical effectiveness of advance directives. Disagreements were resolved by consensus. Data Synthesis Legal and content-related barriers included poor readability (that is, laws in all states were written above a 12th-grade reading level), health care agent or surrogate restrictions (for example, 40 states did not include same-sex or domestic partners as default surrogates), and execution requirements needed to make forms legally valid (for example, 35 states did not allow oral advance directives, and 48 states required witness signatures, a notary public, or both). Vulnerable populations most likely to be affected by these barriers included patients with limited literacy, limited English proficiency, or both who cannot read or execute advance directives; same-sex or domestic partners who may be without legally valid and trusted surrogates; and unbefriended, institutionalized, or homeless patients who may be without witnesses and suitable surrogates. Limitation Only appellate-level legal cases were available, which may have excluded relevant cases. Conclusion Unintended negative consequences of advance directive legal restrictions may prevent all patients, and particularly vulnerable patients, from making and communicating their end

Reflective Journaling for Critical Thinking Development in Advanced Practice Registered Nurse Students.

PubMed

Raterink, Ginger

2016-02-01

Critical thinking, clinical decision making, and critical reflection have been identified as skills required of nurses in every clinical situation. The Educating Nurses: A Call for Radical Transformation report suggested that critical reflection is a key to improving the educational process. Reflective journaling is a tool that helps develop such skills. This article presents the tool of reflective journaling and the use of this process by educators working with students. It describes the use of reflective journaling in graduate nursing education, as well as a scoring process to evaluate the reflection and provide feedback. Students and faculty found the journaling to be helpful for reflection of a clinical situation focused on critical thinking skill development. The rubric scoring tool provided faculty with a method for feedback. Reflective journaling is a tool that faculty and students can use to develop critical thinking skills for the role of the advanced practice RN. A rubric scoring system offers a consistent format for feedback. Copyright 2016, SLACK Incorporated.

Advanced clinical insights & practice: ischemic heart disease.

PubMed

Benner, Randall W; Zavarella, Matthew S

2008-03-01

This issue sees the debut of a new series of continuing education articles. The series, Advanced Clinical Insights & Practice, is designed to provide continuing education to an ever-expanding realm of paramedicine that needs more of it: the critical care transport paramedic. Secondly, and equally important, are the benefits that can be reaped by other certification levels reading this feature. For EMT-Basics and Intermediates, it will provide a great enhancement to your core knowledge, although most of the interventions discussed will be beyond your traditional scope. For paramedics, it will augment both your pathophysiological understanding and clinical assessment/management skills of diseases and injuries discussed. Ultimately though, it is hoped that anyone who reads these articles will become a better clinician. The next article will appear in the July issue.

Major clinical research advances in gynecologic cancer in 2013.

PubMed

Suh, Dong Hoon; Kim, Jae-Weon; Kang, Sokbom; Kim, Hak Jae; Lee, Kyung-Hun

2014-07-01

In 2013, 10 topics were selected for major clinical research advances in gynecologic oncology; these included three topics regarding cervical cancer, three regarding ovarian cancer, two regarding endometrial cancer, and one each regarding breast cancer and radiation oncology. For cervical cancer, bevacizumab was first demonstrated to exhibit outstanding clinical efficacy in a recurrent, metastatic setting. Regarding cervical cancer screening, visual inspections with acetic acid in low-resource settings, p16/Ki-67 double staining, and the follow-up results of four randomized controlled trials of human papillomavirus-based screening methods were reviewed. Laparoscopic para-aortic lymphadenectomy before chemoradiation for locally advanced cervical cancer was the final topic for cervical cancer. Regarding front-line ovarian cancer therapies, dose-dense paclitaxel and carboplatin, intraperitoneal chemotherapy, and other targeted agents administered according to combination or maintenance schedules were discussed. Regarding recurrent ovarian cancer treatment, cediranib, olaparib, and farletuzumab were discussed for platinum-sensitive disease. The final overall survival data associated with a combination of bevacizumab and chemotherapy for platinum-resistant disease were briefly summarized. For endometrial cancer, the potential clinical efficacy of metformin, an antidiabetic drug, in obese patients was followed by integrated genomic analyses from the Cancer Genome Atlas Research Network. For breast cancer, three remarkable advances were reviewed: the long-term effects of continued adjuvant tamoxifen for 10 years, the effects of 2-year versus 1-year adjuvant trastuzumab for human epidermal growth factor receptor 2-positive disease, and the approval of pertuzumab in a neoadjuvant setting with a pathologic complete response as the surrogate endpoint. Finally, the recent large studies of intensity-modulated radiotherapy for gynecologic cancer were briefly summarized.

Regulation of immunotherapeutic products for cancer and FDA’s role in product development and clinical evaluation

PubMed Central

2013-01-01

Immunotherapeutics include drugs and biologics that render therapeutic benefit by harnessing the power of the immune system. The promise of immune-mediated therapies is target specificity with a consequent reduction in off-target side effects. Recent scientific advances have led to clinical trials of both active and passive immunotherapeutic products that have the potential to convert life-ending diseases into chronic but manageable conditions. Clinical trials investigating immunotherapeutics are ongoing with some trials at advanced stages of development. However, as with many products involving novel mechanisms of action, major regulatory and scientific issues arising with clinical use of immunotherapeutic products remain to be addressed. In this review, we address issues related to different immunotherapeutics and provide recommendations for the characterization and evaluation of these products during various stages of product and clinical development. PMID:24764535

Clinical Perspectives on Lupus Genetics: Advances and Opportunities

PubMed Central

James, Judith A.

2014-01-01

Synopsis In recent years, genome wide association studies have led to an explosion in the identification of regions containing confirmed genetic risk variants within complex human diseases, for example in systemic lupus erythematosus (SLE). Many of these strongest SLE genetic associations can be divided into groups based upon their potential roles in different processes implicated in lupus pathogenesis, including ubiquitination (a process of marking proteins for degradation), DNA degradation, innate immunity, cellular immunity (B cell, T cell, neutrophil, monocytes), lymphocyte development, and antigen presentation. Recent advances have also demonstrated several genetic associations with SLE subphenotypes and subcriteria, such as autoantibody production, lupus nephritis, serositis, and arthritis. Despite the broad range of lupus genetic studies to date, many areas for further exploration remain to move lupus genetic studies toward clinically informative endpoints, such as identifying individuals at the greatest risk of end-organ damage, early mortality or poor response to a specific therapeutic regimen. PMID:25034154

Advances in the development of new tuberculosis drugs and treatment regimens.

PubMed

Zumla, Alimuddin; Nahid, Payam; Cole, Stewart T

2013-05-01

Despite the introduction 40 years ago of the inexpensive and effective four-drug (isoniazid, rifampicin, pyrazinamide and ethambutol) treatment regimen, tuberculosis (TB) continues to cause considerable morbidity and mortality worldwide. For the first time since the 1960s, new and novel drugs and regimens for all forms of TB are emerging. Such regimens are likely to utilize both repurposed drugs and new chemical entities, and several of these regimens are now progressing through clinical trials. This article covers current concepts and recent advances in TB drug discovery and development, including an update of ongoing TB treatment trials, newer clinical trial designs, TB biomarkers and adjunct host-directed therapies.

Management of advanced pancreatic cancer in daily clinical practice.

PubMed

Giuliani, Jacopo; Piacentini, Paolo; Bonetti, Andrea

2016-01-01

The aim of this outcome study was to evaluate the management of advanced pancreatic cancer in a real-world clinical practice; few such experiences have been reported in the literature. A retrospective analysis was performed of all consecutive patients with advanced pancreatic ductal adenocarcinoma followed at our medical oncology unit between January 2003 and December 2013. We evaluated 78 patients, mostly with metastatic disease (64.1%). Median follow-up was 10.77 months, by which time 74 patients (94.9%) had died. Median overall survival was 8.29 months. Median age was 67 years. In univariate analysis, pain at onset (p = 0.020), ECOG performance status (p<0.001), stage (p = 0.047), first-line chemotherapy (p<0.001), second-line chemotherapy (p<0.001) and weight loss at diagnosis (p = 0.029) were factors that had an impact on overall survival. In multivariate analysis, the presence of pain at onset (p = 0.043), stage (p = 0.003) and second-line chemotherapy (p = 0.004) were confirmed as independent prognostic factors. Our data, derived from daily clinical practice, confirmed advanced pancreatic cancer as an aggressive malignant disease with a very short expected survival. Second-line treatment seems to provide an advantage in terms of overall survival in patients who showed a partial response as their best response to first-line treatment.

Advanced Telemetry System Development.

DTIC Science & Technology

Progress in advanced telemetry system development is described. Discussions are included of studies leading to the specification for design...characteristics of adaptive and analytical telemetry systems in which the information efficiently utilizes the data channel capacity. Also discussed are...Progress indicates that further sophistication of existing designs in telemetry will be less advantageous than the development of new systems of

Evidence-based use of electronic clinical tracking systems in advanced practice registered nurse education: an integrative review.

PubMed

Branstetter, M Laurie; Smith, Lynette S; Brooks, Andrea F

2014-07-01

Over the past decade, the federal government has mandated healthcare providers to incorporate electronic health records into practice by 2015. This technological update in healthcare documentation has generated a need for advanced practice RN programs to incorporate information technology into education. The National Organization of Nurse Practitioner Faculties created core competencies to guide program standards for advanced practice RN education. One core competency is Technology and Information Literacy. Educational programs are moving toward the utilization of electronic clinical tracking systems to capture students' clinical encounter data. The purpose of this integrative review was to evaluate current research on advanced practice RN students' documentation of clinical encounters utilizing electronic clinical tracking systems to meet advanced practice RN curriculum outcome goals in information technology as defined by the National Organization of Nurse Practitioner Faculties. The state of the science depicts student' and faculty attitudes, preferences, opinions, and data collections of students' clinical encounters. Although electronic clinical tracking systems were utilized to track students' clinical encounters, these systems have not been evaluated for meeting information technology core competency standards. Educational programs are utilizing electronic clinical tracking systems with limited evidence-based literature evaluating the ability of these systems to meet the core competencies in advanced practice RN programs.

A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

PubMed Central

Guise, Jeanne‐Marie; Dolor, Rowena J.; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A.; Pace, Wilson D.; Saltz, Joel; Hersh, William R.; Michener, Lloyd; Carey, Timothy S.

2014-01-01

Abstract An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials. PMID:24472114

Advanced Electrical Materials and Component Development

NASA Technical Reports Server (NTRS)

Schwarze, Gene E.

2003-01-01

The primary means to develop advanced electrical components is to develop new and improved materials for magnetic components (transformers, inductors, etc.), capacitors, and semiconductor switches and diodes. This paper will give a description and status of the internal and external research sponsored by NASA Glenn Research Center on soft magnetic materials, dielectric materials and capacitors, and high quality silicon carbide (SiC) atomically smooth substrates. The rationale for and the benefits of developing advanced electrical materials and components for the PMAD subsystem and also for the total power system will be briefly discussed.

Advanced IGCC/Hydrogen Gas Turbine Development

DOE Office of Scientific and Technical Information (OSTI.GOV)

York, William; Hughes, Michael; Berry, Jonathan

2015-07-30

The objective of this program was to develop the technologies required for a fuel flexible (coal derived hydrogen or syngas) gas turbine for IGCC that met DOE turbine performance goals. The overall DOE Advanced Power System goal was to conduct the research and development (R&D) necessary to produce coal-based IGCC power systems with high efficiency, near-zero emissions, and competitive capital cost. To meet this goal, the DOE Fossil Energy Turbine Program had as an interim objective of 2 to 3 percentage points improvement in combined cycle (CC) efficiency. The final goal is 3 to 5 percentage points improvement in CCmore » efficiency above the state of the art for CC turbines in IGCC applications at the time the program started. The efficiency goals were for NOx emissions of less than 2 ppm NOx (@15 % O2). As a result of the technologies developed under this program, the DOE goals were exceeded with a projected 8 point efficiency improvement. In addition, a new combustion technology was conceived of and developed to overcome the challenges of burning hydrogen and achieving the DOE’s NOx goal. This report also covers the developments under the ARRA-funded portion of the program that include gas turbine technology advancements for improvement in the efficiency, emissions, and cost performance of gas turbines for industrial applications with carbon capture and sequestration. Example applications could be cement plants, chemical plants, refineries, steel and aluminum plants, manufacturing facilities, etc. The DOE’s goal for more than 5 percentage point improvement in efficiency was met with cycle analyses performed for representative IGCC Steel Mill and IGCC Refinery applications. Technologies were developed in this program under the following areas: combustion, larger latter stage buckets, CMC and EBC, advanced materials and coatings, advanced configurations to reduce cooling, sealing and rotor purge flows, turbine aerodynamics, advanced sensors, advancements in

Recent theoretical, neural, and clinical advances in sustained attention research.

PubMed

Fortenbaugh, Francesca C; DeGutis, Joseph; Esterman, Michael

2017-05-01

Models of attention often distinguish among attention subtypes, with classic models separating orienting, switching, and sustaining functions. Compared with other forms of attention, the neurophysiological basis of sustaining attention has received far less notice, yet it is known that momentary failures of sustained attention can have far-ranging negative effects in healthy individuals, and lasting sustained attention deficits are pervasive in clinical populations. In recent years, however, there has been increased interest in characterizing moment-to-moment fluctuations in sustained attention, in addition to the overall vigilance decrement, and understanding how these neurocognitive systems change over the life span and across various clinical populations. The use of novel neuroimaging paradigms and statistical approaches has allowed for better characterization of the neural networks supporting sustained attention and has highlighted dynamic interactions within and across multiple distributed networks that predict behavioral performance. These advances have also provided potential biomarkers to identify individuals with sustained attention deficits. These findings have led to new theoretical models explaining why sustaining focused attention is a challenge for individuals and form the basis for the next generation of sustained attention research, which seeks to accurately diagnose and develop theoretically driven treatments for sustained attention deficits that affect a variety of clinical populations. © 2017 New York Academy of Sciences.

Recent theoretical, neural, and clinical advances in sustained attention research

PubMed Central

Fortenbaugh, Francesca C.; DeGutis, Joseph; Esterman, Michael

2017-01-01

Models of attention often distinguish between attention subtypes, with classic models separating orienting, switching, and sustaining functions. Compared to other forms of attention, the neurophysiological basis of sustaining attention has received far less attention yet it is known that momentary failures of sustained attention can have far ranging negative impacts in healthy individuals and lasting sustained attention deficits are pervasive in clinical populations. In recent years, however, there has been increased interest in characterizing moment-to-moment fluctuations in sustained attention in addition to the overall vigilance decrement and understanding how these neurocognitive systems change over the lifespan and across various clinical populations. The use of novel neuroimaging paradigms and statistical approaches has allowed for better characterization of the neural networks supporting sustained attention, and highlighted dynamic interactions within and across multiple distributed networks that predict behavioral performance. These advances have also provided potential biomarkers to identify individuals with sustained attention deficits. These findings have led to new theoretical models of why sustaining focused attention is a challenge for individuals and form the basis for the next generation of sustained attention research, which seeks to accurately diagnose and develop theoretically-driven treatments for sustained attention deficits that affect a variety of clinical populations. PMID:28260249

Clinical cancer advances 2008: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

PubMed

Winer, Eric; Gralow, Julie; Diller, Lisa; Karlan, Beth; Loehrer, Patrick; Pierce, Lori; Demetri, George; Ganz, Patricia; Kramer, Barnett; Kris, Mark; Markman, Maurie; Mayer, Robert; Pfister, David; Raghavan, Derek; Ramsey, Scott; Reaman, Gregory; Sandler, Howard; Sawaya, Raymond; Schuchter, Lynn; Sweetenham, John; Vahdat, Linda; Schilsky, Richard L

2009-02-10

A message from ASCO'S president: Nearly 40 years ago, President Richard Nixon signed the National Cancer Act, mobilizing the country's resources to make the "conquest of cancer a national crusade." That declaration led to a major investment in cancer research that has significantly improved cancer prevention, treatment, and survival. As a result, two thirds of people diagnosed with cancer today will live at least 5 years after diagnosis, compared with just half in the 1970s. In addition, there are now more than 12 million cancer survivors in the United States--up from 3 million in 1971. Scientifically, we have never been in a better position to advance cancer treatment. Basic scientific research, fueled in recent years by the tools of molecular biology, has generated unprecedented knowledge of cancer development. We now understand many of the cellular pathways that can lead to cancer. We have learned how to develop drugs that block those pathways; increasingly, we know how to personalize therapy to the unique genetics of the tumor and the patient. Yet in 2008, 1.4 million people in the United States will still be diagnosed with cancer, and more than half a million will die as a result of the disease. Some cancers remain stubbornly resistant to treatment, whereas others cannot be detected until they are in their advanced, less curable stages. Biologically, the cancer cell is notoriously wily; each time we throw an obstacle in its path, it finds an alternate route that must then be blocked. To translate our growing basic science knowledge into better treatments for patients, a new national commitment to cancer research is urgently needed. However, funding for cancer research has stagnated. The budgets of the National Institutes of Health and the National Cancer Institute have failed to keep pace with inflation, declining up to 13% in real terms since 2004. Tighter budgets reduce incentives to support high-risk research that could have the largest payoffs. The most

Advanced Mirror Technology Development

NASA Technical Reports Server (NTRS)

Stahl, H. Philip

2017-01-01

The Advanced Mirror Technology Development (AMTD) project matures critical technologies required to enable ultra-stable 4-m-or-larger monolithic or segmented ultraviolet, optical, and infrared (UVOIR) space telescope primary-mirror assemblies for general astrophysics and ultra-high-contrast observations of exoplanets.

Impact of advanced monitoring variables on intraoperative clinical decision-making: an international survey.

PubMed

Joosten, Alexandre; Desebbe, Olivier; Suehiro, Koichi; Essiet, Mfonobong; Alexander, Brenton; Ricks, Cameron; Rinehart, Joseph; Faraoni, David; Cecconi, Maurizio; Van der Linden, Philippe; Cannesson, Maxime

2017-02-01

To assess the relationship between the addition of advanced monitoring variables and changes in clinical decision-making. A 15-questions survey was anonymously emailed to international experts and physician members of five anesthesia societies which focused on assessing treatment decisions of clinicians during three realistic clinical scenarios measured at two distinct time points. The first is when typical case information and basic monitoring (T1) were provided, and then once again after the addition of advanced monitoring variables (T2). We hypothesized that the addition of advanced variables would increase the incidence of an optimal therapeutic decision (a priori defined as the answer with the highest percentage of expert agreement) and decrease the variability among the physician's suggested treatments. The survey was completed by 18 experts and 839 physicians. Overall, adding advanced monitoring did not significantly increase physician response accuracy, with the least substantial changes noted on questions related to volume expansion or vasopressor administration. Moreover, advanced monitoring data did not significantly decrease the high level of initial practice variability in physician suggested treatments (P = 0.13), in contrast to the low variability observed within the expert group (P = 0.039). Additionally, 5-10 years of practice (P < 0.0001) and a cardiovascular subspecialty (P = 0.048) were both physician characteristics associated with a higher rate of optimal therapeutic decisions. The addition of advanced variables was of limited benefit for most physicians, further indicating the need for more in depth education on the clinical value and technical understanding of such variables.

Quantitative imaging biomarkers: the application of advanced image processing and analysis to clinical and preclinical decision making.

PubMed

Prescott, Jeffrey William

2013-02-01

The importance of medical imaging for clinical decision making has been steadily increasing over the last four decades. Recently, there has also been an emphasis on medical imaging for preclinical decision making, i.e., for use in pharamaceutical and medical device development. There is also a drive towards quantification of imaging findings by using quantitative imaging biomarkers, which can improve sensitivity, specificity, accuracy and reproducibility of imaged characteristics used for diagnostic and therapeutic decisions. An important component of the discovery, characterization, validation and application of quantitative imaging biomarkers is the extraction of information and meaning from images through image processing and subsequent analysis. However, many advanced image processing and analysis methods are not applied directly to questions of clinical interest, i.e., for diagnostic and therapeutic decision making, which is a consideration that should be closely linked to the development of such algorithms. This article is meant to address these concerns. First, quantitative imaging biomarkers are introduced by providing definitions and concepts. Then, potential applications of advanced image processing and analysis to areas of quantitative imaging biomarker research are described; specifically, research into osteoarthritis (OA), Alzheimer's disease (AD) and cancer is presented. Then, challenges in quantitative imaging biomarker research are discussed. Finally, a conceptual framework for integrating clinical and preclinical considerations into the development of quantitative imaging biomarkers and their computer-assisted methods of extraction is presented.

The development and validation of the advance care planning questionnaire in Malaysia.

PubMed

Lai, Pauline Siew Mei; Mohd Mudri, Salinah; Chinna, Karuthan; Othman, Sajaratulnisah

2016-10-18

Advance care planning is a voluntary process whereby individual preferences, values and beliefs are used to aid a person in planning for end-of-life care. Currently, there is no local instrument to assess an individual's awareness and attitude towards advance care planning. This study aimed to develop an Advance Care Planning Questionnaire and to determine its validity and reliability among older people in Malaysia. The Advance Care Planning Questionnaire was developed based on literature review. Face and content validity was verified by an expert panel, and piloted among 15 participants. Our study was conducted from October 2013 to February 2014, at an urban primary care clinic in Malaysia. Included were those aged >50 years, who could understand English. A retest was conducted 2 weeks after the first administration. Participants from the pilot study did not encounter any problems in answering the Advance Care Planning Questionnaire. Hence, no further modifications were made. Flesch reading ease was 71. The final version of the Advance Care Planning Questionnaire consists of 66 items: 30 items were measured on a nominal scale, whilst 36 items were measured on a Likert-like scale; of which we were only able to validate 22 items, as the remaining 14 items were descriptive in nature. A total of 245 eligible participants were approached; of which 230 agreed to participate (response rate = 93.9 %). Factor analysis on the 22 items measured on a Likert-scale revealed four domains: "feelings regarding advance care planning", "justifications for advance care planning", "justifications for not having advance care planning: fate and religion", and "justifications for not having advance care planning: avoid thinking about death". The Cronbach's alpha values for items each domain ranged from 0.637-0.915. In test-retest, kappa values ranged from 0.738-0.947. The final Advance Care Planning Questionnaire consisted of 63 items and 4 domains. It was found to be a valid and

Clinical skills assessment of procedural and advanced communication skills: performance expectations of residency program directors

PubMed Central

Langenau, Erik E.; Zhang, Xiuyuan; Roberts, William L.; DeChamplain, Andre F.; Boulet, John R.

2012-01-01

Background High stakes medical licensing programs are planning to augment and adapt current examinations to be relevant for a two-decision point model for licensure: entry into supervised practice and entry into unsupervised practice. Therefore, identifying which skills should be assessed at each decision point is critical for informing examination development, and gathering input from residency program directors is important. Methods Using data from previously developed surveys and expert panels, a web-delivered survey was distributed to 3,443 residency program directors. For each of the 28 procedural and 18 advanced communication skills, program directors were asked which clinical skills should be assessed, by whom, when, and how. Descriptive statistics were collected, and Intraclass Correlations (ICC) were conducted to determine consistency across different specialties. Results Among 347 respondents, program directors reported that all advanced communication and some procedural tasks are important to assess. The following procedures were considered ‘important’ or ‘extremely important’ to assess: sterile technique (93.8%), advanced cardiovascular life support (ACLS) (91.1%), basic life support (BLS) (90.0%), interpretation of electrocardiogram (89.4%) and blood gas (88.7%). Program directors reported that most clinical skills should be assessed at the end of the first year of residency (or later) and not before graduation from medical school. A minority were considered important to assess prior to the start of residency training: demonstration of respectfulness (64%), sterile technique (67.2%), BLS (68.9%), ACLS (65.9%) and phlebotomy (63.5%). Discussion Results from this study support that assessing procedural skills such as cardiac resuscitation, sterile technique, and phlebotomy would be amenable to assessment at the end of medical school, but most procedural and advanced communications skills would be amenable to assessment at the end of the first

Sarcopenia in Alcoholic Liver Disease: Clinical and Molecular Advances.

PubMed

Dasarathy, Jaividhya; McCullough, Arthur J; Dasarathy, Srinivasan

2017-08-01

Despite advances in treatment of alcohol use disorders that focus on increasing abstinence and reducing recidivism, alcoholic liver disease (ALD) is projected to be the major cause of cirrhosis and its complications. Malnutrition is recognized as the most frequent complication in ALD, and despite the high clinical significance, there are no effective therapies to reverse malnutrition in ALD. Malnutrition is a relatively imprecise term, and sarcopenia or skeletal muscle loss, the major component of malnutrition, is primarily responsible for the adverse clinical consequences in patients with liver disease. It is, therefore, critical to define the specific abnormality (sarcopenia) rather than malnutrition in ALD, so that therapies targeting sarcopenia can be developed. Skeletal muscle mass is maintained by a balance between protein synthesis and proteolysis. Both direct effects of ethanol (EtOH) and its metabolites on the skeletal muscle and the consequences of liver disease result in disturbed proteostasis (protein homeostasis) and consequent sarcopenia. Once cirrhosis develops in patients with ALD, abstinence is unlikely to be effective in completely reversing sarcopenia, as other contributors including hyperammonemia, hormonal, and cytokine abnormalities aggravate sarcopenia and maintain a state of anabolic resistance initiated by EtOH. Cirrhosis is also a state of accelerated starvation, with increased gluconeogenesis that requires amino acid diversion from signaling and substrate functions. Novel therapeutic options are being recognized that are likely to supplant the current "deficiency replacement" approach and instead focus on specific molecular perturbations, given the increasing availability of small molecules that can target specific signaling components. Myostatin antagonists, leucine supplementation, and mitochondrial protective agents are currently in various stages of evaluation in preclinical studies to prevent and reverse sarcopenia, in cirrhosis in

Career advancement and professional development in nursing.

PubMed

Adeniran, Rita K; Smith-Glasgow, Mary Ellen; Bhattacharya, Anand; Xu, Yu

2013-01-01

Excellence underscores the need for nurses to keep their skills and competencies current through participation in professional development and career advancement. Evidence suggests that internationally educated nurses (IENs) progress relatively slowly through the career ladder and participate less in professional development compared with nurses educated in the United States (UENs). Mentorship and self-efficacy are considered major determinants of career advancement. The aim of the study was to understand the differences in levels of mentorship function and self-efficacy as well as the differences in participation in professional development and career advancement between UENs and IENs. A descriptive survey design was implemented using a Web-based survey. Significant disparities were noted in the role model function of mentoring and some professional development and career advancement measures between UENs and IENs. Mentorship is essential for professional growth. Sociodemographic characteristics of mentors are important because mentors are role models. Standardized career advancement structures are needed to promote professional growth. Published by Mosby, Inc.

Clinical cancer advances 2011: Annual Report on Progress Against Cancer from the American Society of Clinical Oncology.

PubMed

Vogelzang, Nicholas J; Benowitz, Steven I; Adams, Sylvia; Aghajanian, Carol; Chang, Susan Marina; Dreyer, Zoann Eckert; Janne, Pasi A; Ko, Andrew H; Masters, Greg A; Odenike, Olatoyosi; Patel, Jyoti D; Roth, Bruce J; Samlowski, Wolfram E; Seidman, Andrew D; Tap, William D; Temel, Jennifer S; Von Roenn, Jamie H; Kris, Mark G

2012-01-01

A message from ASCO'S President. It has been forty years since President Richard Nixon signed the National Cancer Act of 1971, which many view as the nation's declaration of the "War on Cancer." The bill has led to major investments in cancer research and significant increases in cancer survival. Today, two-thirds of patients survive at least five years after being diagnosed with cancer compared with just half of all diagnosed patients surviving five years after diagnosis in 1975. The research advances detailed in this year's Clinical Cancer Advances demonstrate that improvements in cancer screening, treatment, and prevention save and improve lives. But although much progress has been made, cancer remains one of the world's most serious health problems. In the United States, the disease is expected to become the nation's leading cause of death in the years ahead as our population ages. I believe we can accelerate the pace of progress, provided that everyone involved in cancer care works together to achieve this goal. It is this viewpoint that has shaped the theme for my presidential term: Collaborating to Conquer Cancer. In practice, this means that physicians and researchers must learn from every patient's experience, ensure greater collaboration between members of a patient's medical team, and involve more patients in the search for cures through clinical trials. Cancer advocates, insurers, and government agencies also have important roles to play. Today, we have an incredible opportunity to improve the quality of cancer care by drawing lessons from the real-world experiences of patients. The American Society of Clinical Oncology (ASCO) is taking the lead in this area, in part through innovative use of health information technology. In addition to our existing quality initiatives, ASCO is working with partners to develop a comprehensive rapid-learning system for cancer care. When complete, this system will provide physicians with personalized, real

Implementation of a professional portfolio: a tool to demonstrate professional development for advanced practice.

PubMed

Chamblee, Tracy B; Dale, Juanita Conkin; Drews, Barbie; Spahis, Joanna; Hardin, Teri

2015-01-01

The literature has a gap related to professional development for APRNs. In the United States, many health care organizations use clinical advancement programs for registered nurses, but APRNs are not often included in these programs. If APRNs are included, advancement opportunities are very limited. At CMC, implementation of a professional portfolio resulted in increased satisfaction among APPs regarding their ability to showcase professional growth and expertise, as well as the uniqueness of their advanced practice. Use of the professional portfolio led to improved recognition by APS and organizational leaders of APP performance excellence during the annual performance evaluation, as well as improved recognition among APP colleagues in terms of nominations for honors and awards.

New clinical advances in immunotherapy for the treatment of solid tumours

PubMed Central

Zavala, Valentina A; Kalergis, Alexis M

2015-01-01

Advances in understanding the mechanisms of cancer cells for evading the immune system surveillance, including how the immune system modulates the phenotype of tumours, have allowed the development of new therapies that benefit from this complex cellular network to specifically target and destroy cancer cells. Immunotherapy researchers have mainly focused on the discovery of tumour antigens that could confer specificity to immune cells to detect and destroy cancer cells, as well as on the mechanisms leading to an improved activation of effector immune cells. The Food and Drug Administration approval in 2010 of ipilumumab for melanoma treatment and of pembrolizumab in 2014, monoclonal antibodies against T-lymphocyte-associated antigen 4 and programmed cell death 1, respectively, are encouraging examples of how research in this area can successfully translate into clinical use with promising results. Currently, several ongoing clinical trials are in progress testing new anti-cancer therapies based on the enhancement of immune cell activity against tumour antigens. Here we discuss the general concepts related to immunotherapy and the recent application to the treatment of cancer with positive results that support their consideration of clinical application to patients. PMID:25826229

Advances in the Immunobiological Therapies for Advanced Melanoma.

PubMed

Pérez Gago, M C; Saavedra Santa Gadea, O; de la Cruz-Merino, L

2017-10-01

Metastatic or locally advanced unresectable melanoma carries a high morbidity and mortality. However, notable advances have been made in recent years in the systemic treatment of this disease, with the appearance of targeted therapy using tyrosine kinase inhibitors that block the mitogen activated protein kinase pathway, and of modern immunotherapy with immune-modulating monoclonal antibodies. In this paper, we provide an update of available data on new immune therapies and we review the clinical development that led to their approval for use in routine clinical practice. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

Collaborative communication: learning from advanced clinical practice patient consultations.

PubMed

Barratt, Julian

2018-04-28

Advanced nurse practitioners, and nurses aspiring to this role, are required to understand how to communicate effectively and on a collaborative basis with patients and carers during consultations, with the aim of enhancing patient outcomes such as improved patient satisfaction, ability to self-manage healthcare needs and adherence to care plans. This article explores collaborative communication in consultations and how best to achieve this, using the author's doctoral observational research based on the findings of a mixed methods observational study of communication in advanced clinical practice patient consultations. ©2018 RCN Publishing Company Ltd. All rights reserved. Not to be copied, transmitted or recorded in any way, in whole or part, without prior permission of the publishers.

Further development of pharmacy student-facilitated diabetes management clinics.

PubMed

Nuffer, Wesley; McCollum, Marianne; Ellis, Samuel L; Turner, Christopher J

2012-04-10

To further develop and evaluate a diabetes disease state management (DSM) program that provided direct patient care responsibilities to advanced pharmacy practice experience (APPE) students as members of healthcare teams. Nine new clinics and 3 established sites that provide self-care management education to patients with diabetes were established and maintained in rural Colorado pharmacies and supported by students in APPE training for 48 weeks per year. The 12 clinics provided 120 APPE student placements in 2010-2011. Students' perceptions of their experiences were positive. Patients who completed the student-supported diabetes self-management education program had improvements in blood glucose, blood pressure, and lipid values. Twelve diabetes DSM clinics provided direct patient care opportunities to APPE students working as part of healthcare teams while expanding healthcare resources in underserved communities in Colorado.

Advances in asthma, allergy and immunology series 2004: basic and clinical immunology.

PubMed

Chinen, Javier; Shearer, William T

2004-08-01

This review highlights some of the most significant advances in basic and clinical immunology that were published from August 2002 to December 2003, focusing on manuscripts that appeared in the Journal. Articles selected were those considered most relevant to Journal readers. With regard to basic immunology, this report includes articles describing FcepsilonRI expression in mucosal Langerhans cells and type II dendritic cells, mechanisms of TH1 and TH2 regulation, the role of Foxp3 in the development of CD4+CD25+ regulatory T cells, and the increasing importance of Toll receptors in immunity. Articles related to clinical immunology that were selected include the first report of lymphocyte subsets values from a large cohort of normal children; the description of new genetic defects in primary immunodeficiencies; a description of the complications of gene therapy for X-linked severe combined immunodeficiency; a report of 79 patients with hyper-IgM syndrome; a report of the mechanism of action and complications of intravenous immunoglobulin; a report of new approaches for immunotherapy; and an article on advances in HIV infection and management, including a report of defensins, small molecules with anti-HIV properties. Also summarized is an article that studied the immune system during a prolonged stay in the Antarctic, a model for human studies on the effect of environmental conditions similar to space expeditions.

Advanced Technology Development for Stirling Convertors

NASA Technical Reports Server (NTRS)

Thieme, Lanny G.; Schreiber, Jeffrey G.

2004-01-01

A high-efficiency Stirling Radioisotope Generator (SRG) for use on potential NASA Space Science missions is being developed by the Department of Energy, Lockheed Martin, Stirling Technology Company, and NASA Glenn Research Center (GRC). These missions may include providing spacecraft onboard electric power for deep space missions or power for unmanned Mars rovers. GRC is also developing advanced technology for Stirling convertors, aimed at substantially improving the specific power and efficiency of the convertor and the overall power system. Performance and mass improvement goals have been established for second- and thirdgeneration Stirling radioisotope power systems. Multiple efforts are underway to achieve these goals, both in-house at GRC and under various grants and contracts. The status and results to date for these efforts will be discussed in this paper. Cleveland State University (CSU) is developing a multi-dimensional Stirling computational fluid dynamics code, capable of modeling complete convertors. A 2-D version of the code is now operational, and validation efforts at both CSU and the University of Minnesota are complementing the code development. A screening of advanced superalloy, refractory metal alloy, and ceramic materials has been completed, and materials have been selected for creep and joining characterization as part of developing a high-temperature heater head. A breadboard characterization is underway for an advanced controller using power electronics for active power factor control with a goal of eliminating the heavy tuning capacitors that are typically needed to achieve near unity power factors. Key Stirling developments just initiated under recent NRA (NASA Research Announcement) awards will also be discussed. These include a lightweight convertor to be developed by Sunpower Inc. and an advanced microfabricated regenerator to be done by CSU.

Enhancing the supportive care of parents with advanced cancer: development of a self-directed educational manual.

PubMed

Turner, Jane; Clavarino, Alexandra; Yates, Patsy; Hargraves, Maryanne; Connors, Veronica; Hausmann, Sue

2008-08-01

Diagnosing and treating young patients with cancer can be stressful for health professionals; however, when the prognosis is poor and the patient has dependent children, even experienced clinicians can feel distressed and helpless. Parents with advanced cancer commonly express anxiety about the impact of the disease on their children, yet health professionals often feel unable to respond constructively because of lack of training, or concern that discussion about such difficult issues will compound parental distress. In response to this problem, an educational manual has been devised to assist oncology staff to better understand the emotional impact of parental advanced cancer, encompassing information about specific reactions of children, including strategies to help children and families cope. This paper describes the development and content of the resource which provides clinically relevant information and evidence-based recommendations to guide supportive care. The manual differs from the more traditional didactic resources in that it examines the very personal impact for professionals working with parents with advanced disease, encouraging reflection and engages the reader in clinical exercises which encourage active learning and application of knowledge into authentic clinical contexts. Although the manual is designed primarily for nurses, it is clear that much of the information is relevant for all health professionals involved in the care of parents with advanced cancer.

Advancing tuberculosis drug regimen development through innovative quantitative translational pharmacology methods and approaches.

PubMed

Hanna, Debra; Romero, Klaus; Schito, Marco

2017-03-01

The development of novel tuberculosis (TB) multi-drug regimens that are more efficacious and of shorter duration requires a robust drug development pipeline. Advances in quantitative modeling and simulation can be used to maximize the utility of patient-level data from prior and contemporary clinical trials, thus optimizing study design for anti-TB regimens. This perspective article highlights the work of seven project teams developing first-in-class translational and quantitative methodologies that aim to inform drug development decision-making, dose selection, trial design, and safety assessments, in order to achieve shorter and safer therapies for patients in need. These tools offer the opportunity to evaluate multiple hypotheses and provide a means to identify, quantify, and understand relevant sources of variability, to optimize translation and clinical trial design. When incorporated into the broader regulatory sciences framework, these efforts have the potential to transform the development paradigm for TB combination development, as well as other areas of global health. Copyright © 2016. Published by Elsevier Ltd.

Recent Advances in Algal Genetic Tool Development

DOE Office of Scientific and Technical Information (OSTI.GOV)

R. Dahlin, Lukas; T. Guarnieri, Michael

The goal of achieving cost-effective biofuels and bioproducts derived from algal biomass will require improvements along the entire value chain, including identification of robust, high-productivity strains and development of advanced genetic tools. Though there have been modest advances in development of genetic systems for the model alga Chlamydomonas reinhardtii, progress in development of algal genetic tools, especially as applied to non-model algae, has generally lagged behind that of more commonly utilized laboratory and industrial microbes. This is in part due to the complex organellar structure of algae, including robust cell walls and intricate compartmentalization of target loci, as well asmore » prevalent gene silencing mechanisms, which hinder facile utilization of conventional genetic engineering tools and methodologies. However, recent progress in global tool development has opened the door for implementation of strain-engineering strategies in industrially-relevant algal strains. Here, we review recent advances in algal genetic tool development and applications in eukaryotic microalgae.« less

Recent Advances in Algal Genetic Tool Development

DOE PAGES

R. Dahlin, Lukas; T. Guarnieri, Michael

2016-06-24

The goal of achieving cost-effective biofuels and bioproducts derived from algal biomass will require improvements along the entire value chain, including identification of robust, high-productivity strains and development of advanced genetic tools. Though there have been modest advances in development of genetic systems for the model alga Chlamydomonas reinhardtii, progress in development of algal genetic tools, especially as applied to non-model algae, has generally lagged behind that of more commonly utilized laboratory and industrial microbes. This is in part due to the complex organellar structure of algae, including robust cell walls and intricate compartmentalization of target loci, as well asmore » prevalent gene silencing mechanisms, which hinder facile utilization of conventional genetic engineering tools and methodologies. However, recent progress in global tool development has opened the door for implementation of strain-engineering strategies in industrially-relevant algal strains. Here, we review recent advances in algal genetic tool development and applications in eukaryotic microalgae.« less

Advancing molecular-guided surgery through probe development and testing in a moderate cost evaluation pipeline

NASA Astrophysics Data System (ADS)

Pogue, Brian W.; Paulsen, Keith D.; Hull, Sally M.; Samkoe, Kimberley S.; Gunn, Jason; Hoopes, Jack; Roberts, David W.; Strong, Theresa V.; Draney, Daniel; Feldwisch, Joachim

2015-03-01

Molecular guided oncology surgery has the potential to transform the way decisions about resection are done, and can be critically important in areas such as neurosurgery where the margins of tumor relative to critical normal tissues are not readily apparent from visual or palpable guidance. Yet there are major financial barriers to advancing agents into clinical trials with commercial backing. We observe that development of these agents in the standard biological therapeutic paradigm is not viable, due to the high up front financial investment needed and the limitations in the revenue models of contrast agents for imaging. The hypothesized solution to this problem is to develop small molecular biologicals tagged with an established fluorescent reporter, through the chemical agent approval pathway, targeting a phase 0 trials initially, such that the initial startup phase can be completely funded by a single NIH grant. In this way, fast trials can be completed to de-risk the development pipeline, and advance the idea of fluorescence-guided surgery (FGS) reporters into human testing. As with biological therapies the potential successes of each agent are still moderate, but this process will allow the field to advance in a more stable and productive manner, rather than relying upon isolated molecules developed at high cost and risk. The pathway proposed and tested here uses peptide synthesis of an epidermal growth factor receptor (EGFR)-binding Affibody molecules, uniquely conjugated to IRDye 800CW, developed and tested in academic and industrial laboratories with well-established records for GMP production, fill and finish, toxicity testing, and early phase clinical trials with image guidance.

Student and Preceptor Advancement in a Dedicated Education Site: Innovation in Clinical Education for Advanced Practice Nurses.

PubMed

Hall, Katherine C; Diffenderfer, Sandy K; Stidham, April; Mullins, Christine M

2018-04-19

In the 1990s, dedicated education units transformed undergraduate preceptorships, but graduate preceptorships remain static. The dyadic nurse practitioner preceptorship model supports an environment where faculty, students, and preceptors may overlook nuances that affect the teaching-learning process. This article describes an innovative clinical education model, Student and Preceptor Advancement in a Dedicated Education Site, designed to improve preceptorships for advanced practice nurses. The focus is on adaptations made to facilitate use in advanced practice nursing programs.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Infant Development: Recent Advances.

ERIC Educational Resources Information Center

Bremner, Gavin, Ed.; Slater, Alan, Ed.; Butterworth, George, Ed.

Noting that the last 30 years have seen enormous increases in the understanding of infancy, this book examines the current state of knowledge regarding infant development. The book's contents stem from meetings of the British Infancy Research Group. Although the book was intended for advanced undergraduates, it would also be useful for advanced…

[Implementation of bedside training and advanced objective structured clinical examination (OSCE) trial to learn and confirm about pharmacy clinical skills].

PubMed

Tokunaga, Jin; Takamura, Norito; Ogata, Kenji; Setoguchi, Nao; Sato, Keizo

2013-01-01

Bedside training for fourth-year students, as well as seminars in hospital pharmacy (vital sign seminars) for fifth-year students at the Department of Pharmacy of Kyushu University of Health and Welfare have been implemented using patient training models and various patient simulators. The introduction of simulation-based pharmaceutical education, where no patients are present, promotes visually, aurally, and tactilely simulated learning regarding the evaluation of vital signs and implementation of physical assessment when disease symptoms are present or adverse effects occur. A patient simulator also promotes the creation of training programs for emergency and critical care, with which basic as well as advanced life support can be practiced. In addition, an advanced objective structured clinical examination (OSCE) trial has been implemented to evaluate skills regarding vital signs and physical assessments. Pharmacists are required to examine vital signs and conduct physical assessment from a pharmaceutical point of view. The introduction of these pharmacy clinical skills will improve the efficacy of drugs, work for the prevention or early detection of adverse effects, and promote the appropriate use of drugs. It is considered that simulation-based pharmaceutical education is essential to understand physical assessment, and such education will ideally be applied and developed according to on-site practices.

Clinical Trial Results Vary Widely, But Always Advance Research | NIH MedlinePlus the Magazine

MedlinePlus

... turn Javascript on. Feature: Clinical Trials Clinical Trial Results Vary Widely, But Always Advance Research Past Issues / ... members met with his surgeon to learn the results: 'When we first met, I told you it ...

Drug development and nonclinical to clinical translational databases: past and current efforts.

PubMed

Monticello, Thomas M

2015-01-01

The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development is a science-focused organization of pharmaceutical and biotechnology companies. The mission of the Preclinical Safety Leadership Group (DruSafe) of the IQ is to advance science-based standards for nonclinical development of pharmaceutical products and to promote high-quality and effective nonclinical safety testing that can enable human risk assessment. DruSafe is creating an industry-wide database to determine the accuracy with which the interpretation of nonclinical safety assessments in animal models correctly predicts human risk in the early clinical development of biopharmaceuticals. This initiative aligns with the 2011 Food and Drug Administration strategic plan to advance regulatory science and modernize toxicology to enhance product safety. Although similar in concept to the initial industry-wide concordance data set conducted by International Life Sciences Institute's Health and Environmental Sciences Institute (HESI/ILSI), the DruSafe database will proactively track concordance, include exposure data and large and small molecules, and will continue to expand with longer duration nonclinical and clinical study comparisons. The output from this work will help identify actual human and animal adverse event data to define both the reliability and the potential limitations of nonclinical data and testing paradigms in predicting human safety in phase 1 clinical trials. © 2014 by The Author(s).

How institutional change and individual researchers helped advance clinical guidelines in American health care.

PubMed

Nigam, Amit

2013-06-01

Clinical guidelines are important tools for managing health care quality. Research on the origins of guidelines primarily focuses on the institutional causes of their emergence and growth. Individual medical researchers, however, have played important roles. This paper develops knowledge of the role of individual medical researchers in advancing guidelines, and of how researchers' efforts were enabled or constrained by broader institutional changes. Drawing on an analytical case study focused on the role of Kerr White, John Wennberg, and Robert Brook, it shows that guidelines were a product of the interplay between institutional change in the medical field and actions by individual researchers, acting as institutional entrepreneurs. Increased government involvement in the health care field triggered the involvement of a range of new actors in health care. These new organizations created a context that allowed individual researchers to advance guidelines by creating job opportunities, providing research funding, and creating opportunities for researchers to engage with the policy process. Individual researchers availed of this context to both advance their ideas, and to draw new actors into the field. Copyright © 2013. Published by Elsevier Ltd.

Development Of Advanced Welding Control System

NASA Technical Reports Server (NTRS)

1990-01-01

Report describes development of next-generation control system for variable-polarity plasma arc (VPPA) welding. When fully developed, system expected to incorporate advanced sensors and adaptive control of position of and current in welding torch.

Introducing Advanced Clinical Reasoning to an Adult Learning Disability Service

ERIC Educational Resources Information Center

Stansfield, Jois; Matthews, Alison

2014-01-01

The advanced clinical reasoning approach is widely adopted in speech and language therapy practice. This article reports on the introduction of the approach across a multidisciplinary adult learning disability service and staff reports on the impact of this initiative. Staff and team managers reported that the training had a positive impact on…

Current Molecular Targeted Therapy in Advanced Gastric Cancer: A Comprehensive Review of Therapeutic Mechanism, Clinical Trials, and Practical Application

PubMed Central

Li, Kaichun; Li, Jin

2016-01-01

Despite the great progress in the treatment of gastric cancer, it is still the third leading cause of cancer death worldwide. Patients often miss the opportunity for a surgical cure, because the cancer has already developed into advanced cancer when identified. Compared to best supportive care, chemotherapy can improve quality of life and prolong survival time, but the overall survival is often short. Due to the molecular study of gastric cancer, new molecular targeted drugs have entered the clinical use. Trastuzumab, an antibody targeting human epidermal growth factor receptor 2 (HER2), can significantly improve survival in advanced gastric cancer patients with HER2 overexpression. Second-line treatment of advanced gastric cancer with ramucirumab, an antibody targeting VEGFR-2, alone or in combination with paclitaxel, has been proved to provide a beneficial effect. The VEGFR-2 tyrosine kinase inhibitor, apatinib, can improve the survival of advanced gastric cancer patients after second-line chemotherapy failure. Unfortunately, none of the EGFR targeting antibodies (cetuximab or panitumumab), VEGF targeting monoclonal antibodies (bevacizumab), mTOR inhibitor (everolimus), or HGF/MET pathway targeting drugs has a significant survival benefit. Many other clinical trials based on molecular markers are underway. This review will summarize targeted therapies for advanced gastric cancer. PMID:26880889

The current status and trend of clinical pharmacology in developing countries

PubMed Central

2013-01-01

medicines. Conclusion Clinical pharmacology in developing countries is advancing in a different way to that in the developed world and continuing support for these efforts will go a long way in promoting improved health for all. PMID:24074056

Early developments and clinical applications of total parenteral nutrition.

PubMed

Dudrick, Stanley J

2003-01-01

This article recounts the conditions and status of surgical nutrition support in the 1960s and the antecedent basic and clinical investigational work leading to the development of a practical and efficacious method of adequate nourishment entirely by vein in Beagle puppies; describes the subsequent clinical application of the knowledge, techniques, and technology to the first successful long-term total parenteral nutrition (TPN) support of critically ill pediatric and adult patients; and admonishes nutritionists of all backgrounds that some need for parenteral nutrition will likely always exist and that it is incumbent upon everyone to continue endeavors to advance the germinal methodology to perfection. The relevant indications, limitations, hindrances, motivational factors, and studies regarding the development of TPN are reviewed, and the fundamental investigational work culminating in the first successful growth and development of Beagle puppies and a human infant fed entirely by vein are described firsthand. The details of the orderly and logical scientific development of the principles and components of the techniques in animals, infants, and adults are related. Knowledge, techniques, and technologic constituents of the first successful long-term TPN system were developed in the basic biochemical and animal laboratories initially in 6 puppies and subsequently adapted clinically for the efficacious long-term i.v. support of 6 critically ill surgical adult patients and a newborn infant before its widespread clinical application. Long-term TPN was inaugurated successfully as a safe and effective i.v. feeding technique nearly 4 decades ago. However, basic and clinical investigations must continue to be encouraged, supported, and carried out in the quest to perfect the current rudimentary technology, methodology, and outcomes.

Developing education tailored to clinical roles: genetics education for haemophilia nurses.

PubMed

Burke, Sarah; Barker, Colin; Marshall, Dianne

2012-01-01

Genetics is an important component of the clinical work of haemophilia nurses, but little was known about the genetic education needs of haemophilia nurses. To develop, deliver and evaluate genetic education for haemophilia nurses, based on clinical roles. Perceived relevance of genetics to haemophilia nursing practice was explored using electronic voting (response rate 75%, 58/77). A follow-on questionnaire to a volunteer sample of participants explored educational preferences (response rate 41%, 17/41). Results informed development of a two-hour genetics workshop session, evaluated by questionnaire (response rate 67%, 47/70). Genetic competences were considered relevant to the clinical practice of haemophilia nurses, and learning needs were identified. Preference was expressed for education focused on practical skills. During the subsequent workshop, participant confidence ratings significantly increased in the four areas addressed. Planned changes to clinical care and training were reported. Within new areas of advanced nursing practice, learning needs can be addressed by: identifying relevant clinical activities and associated learning needs; creating a strategy and resources using preferred forms of delivery; implementing the strategy; and evaluating its effect. This will enable development of education that addresses the real needs of practising nurses, grounded in their daily clinical practice. Copyright © 2011 Elsevier Ltd. All rights reserved.

Brayton advanced heat receiver development program

NASA Technical Reports Server (NTRS)

Heidenreich, G. R.; Downing, R. S.; Lacey, Dovie E.

1989-01-01

NASA Lewis Research Center is managing an advanced solar dynamic (ASD) space power program. The objective of the ASD program is to develop small and lightweight solar dynamic systems which show significant improvement in efficiency and specific mass over the baseline design derived from the Space Station Freedom technology. The advanced heat receiver development program is a phased program to design, fabricate and test elements of a 7-kWe heat-receiver/thermal-energy-storage subsystem. Receivers for both Brayton and Stirling heat engines are being developed under separate contracts. Phase I, described here, is the current eighteen month effort to design and perform critical technology experiments on innovative concepts designed to reduce mass without compromising thermal efficiency and reliability.

Technological advances in perioperative monitoring: Current concepts and clinical perspectives

PubMed Central

Chilkoti, Geetanjali; Wadhwa, Rachna; Saxena, Ashok Kumar

2015-01-01

Minimal mandatory monitoring in the perioperative period recommended by Association of Anesthetists of Great Britain and Ireland and American Society of Anesthesiologists are universally acknowledged and has become an integral part of the anesthesia practice. The technologies in perioperative monitoring have advanced, and the availability and clinical applications have multiplied exponentially. Newer monitoring techniques include depth of anesthesia monitoring, goal-directed fluid therapy, transesophageal echocardiography, advanced neurological monitoring, improved alarm system and technological advancement in objective pain assessment. Various factors that need to be considered with the use of improved monitoring techniques are their validation data, patient outcome, safety profile, cost-effectiveness, awareness of the possible adverse events, knowledge of technical principle and ability of the convenient routine handling. In this review, we will discuss the new monitoring techniques in anesthesia, their advantages, deficiencies, limitations, their comparison to the conventional methods and their effect on patient outcome, if any. PMID:25788767

Technological advances in perioperative monitoring: Current concepts and clinical perspectives.

PubMed

Chilkoti, Geetanjali; Wadhwa, Rachna; Saxena, Ashok Kumar

2015-01-01

Minimal mandatory monitoring in the perioperative period recommended by Association of Anesthetists of Great Britain and Ireland and American Society of Anesthesiologists are universally acknowledged and has become an integral part of the anesthesia practice. The technologies in perioperative monitoring have advanced, and the availability and clinical applications have multiplied exponentially. Newer monitoring techniques include depth of anesthesia monitoring, goal-directed fluid therapy, transesophageal echocardiography, advanced neurological monitoring, improved alarm system and technological advancement in objective pain assessment. Various factors that need to be considered with the use of improved monitoring techniques are their validation data, patient outcome, safety profile, cost-effectiveness, awareness of the possible adverse events, knowledge of technical principle and ability of the convenient routine handling. In this review, we will discuss the new monitoring techniques in anesthesia, their advantages, deficiencies, limitations, their comparison to the conventional methods and their effect on patient outcome, if any.

Clinical Cancer Advances 2013: Annual Report on Progress Against Cancer from the American Society of Clinical Oncology.

PubMed

Patel, Jyoti D; Krilov, Lada; Adams, Sylvia; Aghajanian, Carol; Basch, Ethan; Brose, Marcia S; Carroll, William L; de Lima, Marcos; Gilbert, Mark R; Kris, Mark G; Marshall, John L; Masters, Gregory A; O'Day, Steven J; Polite, Blasé; Schwartz, Gary K; Sharma, Sunil; Thompson, Ian; Vogelzang, Nicholas J; Roth, Bruce J

2014-01-10

Since its founding in 1964, the American Society of Clinical Oncology (ASCO) has been committed to improving cancer outcomes through research and the delivery of quality care. Research is the bedrock of discovering better treatments--providing hope to the millions of individuals who face a cancer diagnosis each year. The studies featured in "Clinical Cancer Advances 2013: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology" represent the invaluable contributions of thousands of patients who participate in clinical trials and the scientists who conduct basic and clinical research. The insights described in this report, such as how cancers hide from the immune system and why cancers may become resistant to targeted drugs, enable us to envision a future in which cancer will be even more controllable and preventable. The scientific process is thoughtful, deliberate, and sometimes slow, but each advance, while helping patients, now also points toward new research questions and unexplored opportunities. Both dramatic and subtle breakthroughs occur so that progress against cancer typically builds over many years. Success requires vision, persistence, and a long-term commitment to supporting cancer research and training. Our nation's longstanding investment in federally funded cancer research has contributed significantly to a growing array of effective new treatments and a much deeper understanding of the drivers of cancer. But despite this progress, our position as a world leader in advancing medical knowledge and our ability to attract the most promising and talented investigators are now threatened by an acute problem: Federal funding for cancer research has steadily eroded over the past decade, and only 15% of the ever-shrinking budget is actually spent on clinical trials. This dismal reality threatens the pace of progress against cancer and undermines our ability to address the continuing needs of our patients. Despite this

Development of advanced fuel cell system, phase 2

NASA Technical Reports Server (NTRS)

Handley, L. M.; Meyer, A. P.; Bell, W. F.

1973-01-01

A multiple task research and development program was performed to improve the weight, life, and performance characteristics of hydrogen-oxygen alkaline fuel cells for advanced power systems. Development and characterization of a very stable gold alloy catalyst was continued from Phase I of the program. A polymer material for fabrication of cell structural components was identified and its long term compatibility with the fuel cell environment was demonstrated in cell tests. Full scale partial cell stacks, with advanced design closed cycle evaporative coolers, were tested. The characteristics demonstrated in these tests verified the feasibility of developing the engineering model system concept into an advanced lightweight long life powerplant.

Manufacturing development of DC-10 advanced rudder

NASA Technical Reports Server (NTRS)

Cominsky, A.

1979-01-01

The design, manufacture, and ground test activities during development of production methods for an advanced composite rudder for the DC-10 transport aircraft are described. The advanced composite aft rudder is satisfactory for airline service and a cost saving in a full production manufacturing mode is anticipated.

The advanced software development workstation project

NASA Technical Reports Server (NTRS)

Fridge, Ernest M., III; Pitman, Charles L.

1991-01-01

The Advanced Software Development Workstation (ASDW) task is researching and developing the technologies required to support Computer Aided Software Engineering (CASE) with the emphasis on those advanced methods, tools, and processes that will be of benefit to support all NASA programs. Immediate goals are to provide research and prototype tools that will increase productivity, in the near term, in projects such as the Software Support Environment (SSE), the Space Station Control Center (SSCC), and the Flight Analysis and Design System (FADS) which will be used to support the Space Shuttle and Space Station Freedom. Goals also include providing technology for development, evolution, maintenance, and operations. The technologies under research and development in the ASDW project are targeted to provide productivity enhancements during the software life cycle phase of enterprise and information system modeling, requirements generation and analysis, system design and coding, and system use and maintenance. On-line user's guides will assist users in operating the developed information system with knowledge base expert assistance.

Systematic genomic identification of colorectal cancer genes delineating advanced from early clinical stage and metastasis

PubMed Central

2013-01-01

Background Colorectal cancer is the third leading cause of cancer deaths in the United States. The initial assessment of colorectal cancer involves clinical staging that takes into account the extent of primary tumor invasion, determining the number of lymph nodes with metastatic cancer and the identification of metastatic sites in other organs. Advanced clinical stage indicates metastatic cancer, either in regional lymph nodes or in distant organs. While the genomic and genetic basis of colorectal cancer has been elucidated to some degree, less is known about the identity of specific cancer genes that are associated with advanced clinical stage and metastasis. Methods We compiled multiple genomic data types (mutations, copy number alterations, gene expression and methylation status) as well as clinical meta-data from The Cancer Genome Atlas (TCGA). We used an elastic-net regularized regression method on the combined genomic data to identify genetic aberrations and their associated cancer genes that are indicators of clinical stage. We ranked candidate genes by their regression coefficient and level of support from multiple assay modalities. Results A fit of the elastic-net regularized regression to 197 samples and integrated analysis of four genomic platforms identified the set of top gene predictors of advanced clinical stage, including: WRN, SYK, DDX5 and ADRA2C. These genetic features were identified robustly in bootstrap resampling analysis. Conclusions We conducted an analysis integrating multiple genomic features including mutations, copy number alterations, gene expression and methylation. This integrated approach in which one considers all of these genomic features performs better than any individual genomic assay. We identified multiple genes that robustly delineate advanced clinical stage, suggesting their possible role in colorectal cancer metastatic progression. PMID:24308539

Technological advances in precision medicine and drug development.

PubMed

Maggi, Elaine; Patterson, Nicole E; Montagna, Cristina

New technologies are rapidly becoming available to expand the arsenal of tools accessible for precision medicine and to support the development of new therapeutics. Advances in liquid biopsies, which analyze cells, DNA, RNA, proteins, or vesicles isolated from the blood, have gained particular interest for their uses in acquiring information reflecting the biology of tumors and metastatic tissues. Through advancements in DNA sequencing that have merged unprecedented accuracy with affordable cost, personalized treatments based on genetic variations are becoming a real possibility. Extraordinary progress has been achieved in the development of biological therapies aimed to even further advance personalized treatments. We provide a summary of current and future applications of blood based liquid biopsies and how new technologies are utilized for the development of biological therapeutic treatments. We discuss current and future sequencing methods with an emphasis on how technological advances will support the progress in the field of precision medicine.

The Influence of Big (Clinical) Data and Genomics on Precision Medicine and Drug Development.

PubMed

Denny, Joshua C; Van Driest, Sara L; Wei, Wei-Qi; Roden, Dan M

2018-03-01

Drug development continues to be costly and slow, with medications failing due to lack of efficacy or presence of toxicity. The promise of pharmacogenomic discovery includes tailoring therapeutics based on an individual's genetic makeup, rational drug development, and repurposing medications. Rapid growth of large research cohorts, linked to electronic health record (EHR) data, fuels discovery of new genetic variants predicting drug action, supports Mendelian randomization experiments to show drug efficacy, and suggests new indications for existing medications. New biomedical informatics and machine-learning approaches advance the ability to interpret clinical information, enabling identification of complex phenotypes and subpopulations of patients. We review the recent history of use of "big data" from EHR-based cohorts and biobanks supporting these activities. Future studies using EHR data, other information sources, and new methods will promote a foundation for discovery to more rapidly advance precision medicine. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Advance directives: the clinical nurse specialist as a change agent.

PubMed

Meehan, Karen Anne

2009-01-01

The purpose of this article is to describe the impact the clinical nurse specialist (CNS) has on the advance directive process within the cardiac surgery patient population. As a change agent, the CNS needs to be able to increase the number of advance directives obtained and increase the provision of dignified, self-directed, quality patient care. With requirements from The Joint Commission and the Patient Self-determination Act, the change in process must take place to ensure that healthcare professionals are doing all they can do to carry out a patient's wishes. The 6-Source Influencer Model is applied to a case study to illustrate the role of the CNS as a change agent. Following this model, the CNS can facilitate lasting institutional change in the advance directive process. Based on the example, it is possible that a CNS can act as a change agent for other patient populations within the healthcare setting.

A clinical ladder for occupational health nurses.

PubMed

Lang, Yolanda C

2010-06-01

Occupational health nurses must have a growing, expanding knowledge base to remain current in practice. The American Board for Occupational Health Nurses, Inc. encourages advancement with the availability of certification examinations. Health care centers support clinical advancement programs for bedside nurses. Nurses who continue their education either through a degree program or via continuing education or certification advance up the clinical ladder, receiving a higher salary, recognition from their peers, and perhaps even financial assistance to continue climbing, yet occupational health nurses do not have their own clinical advancement ladder. This article examines the steps necessary to develop a clinical ladder and presents a clinical ladder specific to occupational health nursing developed by the author. Copyright 2010, SLACK Incorporated.

FOCIS goes south: advances in translational and clinical immunology.

PubMed

Kalergis, Alexis M; Anegon, Ignacio; González, Pablo A

2017-09-01

FOCIS goes South: Advances in Translational and Clinical Immunology was the first Federation of Clinical Immunology Societies (FOCIS) ( www.focisnet.org ) meeting held in Latin America (May 15-17, 2017, Santiago de Chile, Chile). The meeting was organized as a 3-day workshop and was fostered by the Millennium Institute on Immunology and Immunotherapy, a recently nominated FOCIS Center of Excellence. The workshop brought together FOCIS associates, such as members of the FOCIS Board of Directors, Directors of different Centers of Excellence, regional speakers and 350 attendees. The Meeting covered aspects of immune regulation and modulation, as well as immunotherapy in areas of autoimmunity, transplantation, cancer and infectious diseases, among others. The activity also had a full-day immunology course and a day-long flow cytometry course.

Transmission blocking malaria vaccines: Assays and candidates in clinical development.

PubMed

Sauerwein, R W; Bousema, T

2015-12-22

Stimulated by recent advances in malaria control and increased funding, the elimination of malaria is now considered to be an attainable goal for an increasing number of malaria-endemic regions. This has boosted the interest in transmission-reducing interventions including vaccines that target sexual, sporogenic, and/or mosquito-stage antigens to interrupt malaria transmission (SSM-VIMT). SSM-VIMT aim to prevent human malaria infection in vaccinated communities by inhibiting parasite development within the mosquito after a blood meal taken from a gametocyte carrier. Only a handful of target antigens are in clinical development and progress has been slow over the years. Major stumbling blocks include (i) the expression of appropriately folded target proteins and their downstream purification, (ii) insufficient induction of sustained functional blocking antibody titers by candidate vaccines in humans, and (iii) validation of a number of (bio)-assays as correlate for blocking activity in the field. Here we discuss clinical manufacturing and testing of current SSM-VIMT candidates and the latest bio-assay development for clinical evaluation. New testing strategies are discussed that may accelerate the evaluation and application of SSM-VIMT. Copyright © 2015. Published by Elsevier Ltd.

Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation.

PubMed

de Wilde, Sofieke; Veltrop-Duits, Louise; Hoozemans-Strik, Merel; Ras, Thirza; Blom-Veenman, Janine; Guchelaar, Henk-Jan; Zandvliet, Maarten; Meij, Pauline

2016-06-01

Since the implementation of the European Union (EU) regulation for advanced therapy medicinal products (ATMPs) in 2009, only six ATMPs achieved marketing authorization approval in the EU. Recognizing the major developments in the ATMP field, starting mostly in academic institutions, we investigated which hurdles were experienced in the whole pathway of ATMP development towards clinical care. Quality interviews were executed with different stakeholders in The Netherlands involved in the ATMP development field, e.g. academic research groups, national authorities and patient organizations. Based on the hurdles mentioned in the interviews, questionnaires were subsequently sent to the academic principal investigators (PIs) and ATMP good manufacturing practice (GMP) facility managers to quantify these hurdles. Besides the familiar regulatory routes of marketing authorization (MA) and hospital exemption (HE), a part of the academic PIs perceived that ATMPs should become available by the Tissues and Cells Directive or did not anticipate on the next development steps towards implementation of their ATMP towards regular clinical care. The main hurdles identified were: inadequate financial support, rapidly evolving field, study-related problems, lacking regulatory knowledge, lack of collaborations and responsibility issues. Creating an academic environment stimulating and planning ATMP development and licensing as well as investing in expanding the relevant regulatory knowledge in academic institutions seems a prerequisite to develop ATMPs from bench to patient. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Advances in developing rapid, reliable and portable detection systems for alcohol.

PubMed

Thungon, Phurpa Dema; Kakoti, Ankana; Ngashangva, Lightson; Goswami, Pranab

2017-11-15

Development of portable, reliable, sensitive, simple, and inexpensive detection system for alcohol has been an instinctive demand not only in traditional brewing, pharmaceutical, food and clinical industries but also in rapidly growing alcohol based fuel industries. Highly sensitive, selective, and reliable alcohol detections are currently amenable typically through the sophisticated instrument based analyses confined mostly to the state-of-art analytical laboratory facilities. With the growing demand of rapid and reliable alcohol detection systems, an all-round attempt has been made over the past decade encompassing various disciplines from basic and engineering sciences. Of late, the research for developing small-scale portable alcohol detection system has been accelerated with the advent of emerging miniaturization techniques, advanced materials and sensing platforms such as lab-on-chip, lab-on-CD, lab-on-paper etc. With these new inter-disciplinary approaches along with the support from the parallel knowledge growth on rapid detection systems being pursued for various targets, the progress on translating the proof-of-concepts to commercially viable and environment friendly portable alcohol detection systems is gaining pace. Here, we summarize the progress made over the years on the alcohol detection systems, with a focus on recent advancement towards developing portable, simple and efficient alcohol sensors. Copyright © 2017 Elsevier B.V. All rights reserved.

Emerging Research and Clinical Development Trends of Liposome and Lipid Nanoparticle Drug Delivery Systems

PubMed Central

KRAFT, JOHN C.; FREELING, JENNIFER P.; WANG, ZIYAO; HO, RODNEY J. Y.

2014-01-01

Liposomes are spherical-enclosed membrane vesicles mainly constructed with lipids. Lipid nanoparticles are loaded with therapeutics and may not contain an enclosed bilayer. The majority of those clinically approved have diameters of 50–300 nm. The growing interest in nanomedicine has fueled lipid–drug and lipid–protein studies, which provide a foundation for developing lipid particles that improve drug potency and reduce off-target effects. Integrating advances in lipid membrane research has enabled therapeutic development. At present, about 600 clinical trials involve lipid particle drug delivery systems. Greater understanding of pharmacokinetics, biodistribution, and disposition of lipid–drug particles facilitated particle surface hydration technology (with polyethylene glycol) to reduce rapid clearance and provide sufficient blood circulation time for drug to reach target tissues and cells. Surface hydration enabled the liposome-encapsulated cancer drug doxorubicin (Doxil) to gain clinical approval in 1995. Fifteen lipidic therapeutics are now clinically approved. Although much research involves attaching lipid particles to ligands selective for occult cells and tissues, preparation procedures are often complex and pose scale-up challenges. With emerging knowledge in drug target and lipid–drug distribution in the body, a systems approach that integrates knowledge to design and scale lipid–drug particles may further advance translation of these systems to improve therapeutic safety and efficacy. PMID:24338748

CCR5 receptor antagonists in preclinical to phase II clinical development for treatment of HIV

PubMed Central

Kim, Michelle B.; Giesler, Kyle E.; Tahirovic, Yesim A.; Truax, Valarie M.; Liotta, Dennis C.; Wilson, Lawrence J.

2018-01-01

Introduction The chemokine receptor CCR5 has garnered significant attention in recent years as a target to treat HIV infection largely due to the approval and success of the drug Maraviroc. The side effects and inefficiencies with other first generation agents led to failed clinical trials, prompting the development of newer CCR5 antagonists. Areas covered This review aims to survey the current status of ‘next generation’ CCR5 antagonists in the preclinical pipeline with an emphasis on emerging agents for the treatment of HIV infection. These efforts have culminated in the identification of advanced second-generation agents to reach the clinic and the dual CCR5/CCR2 antagonist Cenicriviroc as the most advanced currently in phase II clinical studies. Expert opinion The clinical success of CCR5 inhibitors for treatment of HIV infection has rested largely on studies of Maraviroc and a second-generation dual CCR5/CCR2 antagonist Cenicriviroc. Although research efforts identified several promising preclinical candidates, these were dropped during early clinical studies. Despite patient access to Maraviroc, there is insufficient enthusiasm surrounding its use as front-line therapy for treatment of HIV. The non-HIV infection related development activities for Maraviroc and Cenicriviroc may help drive future interests. PMID:27791451

Developing a Peer Mentorship Program to Increase Competence in Clinical Supervision in Clinical Psychology Doctoral Training Programs.

PubMed

Foxwell, Aleksandra A; Kennard, Beth D; Rodgers, Cynthia; Wolfe, Kristin L; Cassedy, Hannah F; Thomas, Anna

2017-12-01

Supervision has recently been recognized as a core competency for clinical psychologists. This recognition of supervision as a distinct competency has evolved in the context of an overall focus on competency-based education and training in health service psychology, and has recently gained momentum. Few clinical psychology doctoral programs offer formal training experiences in providing supervision. A pilot peer mentorship program (PMP) where graduate students were trained in the knowledge and practice of supervision was developed. The focus of the PMP was to develop basic supervision skills in advanced clinical psychology graduate students, as well as to train junior doctoral students in fundamental clinical and practical skills. Advanced doctoral students were matched to junior doctoral students to gain experience in and increase knowledge base in best practices of supervision skills. The 9-month program consisted of monthly mentorship meetings and three training sessions. The results suggested that mentors reported a 30% or more shift from the category of not competent to needs improvement or competent, in the following supervision competencies: theories of supervision, improved skill in supervision modalities, acquired knowledge in supervision, and supervision experience. Furthermore, 50% of the mentors reported that they were not competent in supervision experience at baseline and only 10% reported that they were not competent at the end of the program. Satisfaction data suggested that satisfaction with the program was high, with 75% of participants indicating increased knowledge base in supervision, and 90% indicating that it was a positive addition to their training program. This program was feasible and acceptable and appears to have had a positive impact on the graduate students who participated. Students reported both high satisfaction with the program as well as an increase in knowledge base and experience in supervision skills.

Advanced thermionic converter development

NASA Technical Reports Server (NTRS)

Huffman, F. N.; Lieb, D.; Briere, T. R.; Sommer, A. H.; Rufeh, F.

1976-01-01

Recent progress at Thermo Electron in developing advanced thermionic converters is summarized with particular attention paid to the development of electrodes, diodes, and triodes. It is found that one class of materials (ZnO, BaO and SrO) provides interesting cesiated work functions (1.3-1.4 eV) without additional oxygen. The second class of materials studied (rare earth oxides and hexaborides) gives cesiated/oxygenated work functions of less than 1.2 eV. Five techniques of oxygen addition to thermionic converters are discussed. Vapor deposited tungsten oxide collector diodes and the reflux converter are considered.

Recent advances in proteomic applications for schistosomiasis research: potential clinical impact.

PubMed

Sotillo, Javier; Doolan, Denise; Loukas, Alex

2017-02-01

Schistosomiasis is a neglected tropical disease affecting hundreds of millions of people worldwide. Recent advances in the field of proteomics and the development of new and highly sensitive mass spectrometers and quantitative techniques have provided new tools for advancing the molecular biology, cell biology, diagnosis and vaccine development for public health threats such as schistosomiasis. Areas covered: In this review we describe the latest advances in research that utilizes proteomics-based tools to address some of the key challenges to developing effective interventions against schistosomiasis. We also provide information about the potential of extracellular vesicles to advance the fight against this devastating disease. Expert commentary: Different proteins are already being tested as vaccines against schistosomiasis with promising results. The re-analysis of the Schistosoma spp. proteomes using new and more sensitive mass spectrometers as well as better separation approaches will help identify more vaccine targets in a rational and informed manner. In addition, the recent development of new proteome microarrays will facilitate characterisation of novel markers of infection as well as new vaccine and diagnostic candidate antigens.

How Do Pharmacists Develop into Advanced Level Practitioners? Learning from the Experiences of Critical Care Pharmacists.

PubMed

Seneviratne, Ruth E; Bradbury, Helen; Bourne, Richard S

2017-07-07

The national UK standards for critical care highlight the need for clinical pharmacists to practise at an advanced level (equivalent to Royal Pharmaceutical Society, Great Britain, Faculty Advanced Stage II (MFRPSII)) and above. Currently the UK is unable to meet the workforce capacity requirements set out in the national standards in terms of numbers of pharmacist working at advanced level and above. The aim of this study was to identify the strategies, barriers and challenges to achieving Advanced Level Practice (ALP) by learning from the experiences of advanced level critical care pharmacists within the UK. Eight participants were recruited to complete semi-structured interviews on their views and experiences of ALP. The interviews were analysed thematically and three overarching themes were identified; support, work-based learning and reflective practice. The results of this study highlight that to increase the number of MFRPSII level practitioners within critical care support for their ALP development is required. This support involves developing face-to-face access to expert critical care pharmacists within a national training programme. Additionally, chief pharmacists need to implement drivers including in house mentorship and peer review programmes and the need to align job descriptions and appraisals to the Royal Pharmaceutical Society, Great Britain, Advanced Practice Framework (APF).

How Do Pharmacists Develop into Advanced Level Practitioners? Learning from the Experiences of Critical Care Pharmacists

PubMed Central

Seneviratne, Ruth E.; Bradbury, Helen

2017-01-01

The national UK standards for critical care highlight the need for clinical pharmacists to practise at an advanced level (equivalent to Royal Pharmaceutical Society, Great Britain, Faculty Advanced Stage II (MFRPSII)) and above. Currently the UK is unable to meet the workforce capacity requirements set out in the national standards in terms of numbers of pharmacist working at advanced level and above. The aim of this study was to identify the strategies, barriers and challenges to achieving Advanced Level Practice (ALP) by learning from the experiences of advanced level critical care pharmacists within the UK. Eight participants were recruited to complete semi-structured interviews on their views and experiences of ALP. The interviews were analysed thematically and three overarching themes were identified; support, work-based learning and reflective practice. The results of this study highlight that to increase the number of MFRPSII level practitioners within critical care support for their ALP development is required. This support involves developing face-to-face access to expert critical care pharmacists within a national training programme. Additionally, chief pharmacists need to implement drivers including in house mentorship and peer review programmes and the need to align job descriptions and appraisals to the Royal Pharmaceutical Society, Great Britain, Advanced Practice Framework (APF). PMID:28970450

Leadership capabilities of physiotherapy leaders in Ireland: Part 2. Clinical specialists and advanced physiotherapy practitioners.

PubMed

McGowan, E; Elliott, N; Stokes, E

2018-05-07

Investigation of the leadership capabilities of physiotherapy managers found that they report predominantly demonstrating capabilities associated with the human resource and structural frames. However, little is known about the leadership capabilities of clinical specialists and advanced physiotherapy practitioners (APPs) who also are identified as having responsibility for leadership. To explore clinical specialists´ and APPs' perceptions of their leadership capabilities and compare them with the reported leadership capabilities of physiotherapy managers. Semi-structured interviews were conducted with a purposive sample of 17 physiotherapy clinical specialists and APPs from a range of practice settings across Ireland. The interviews were analyzed using template analysis and the coding template was based on the Bolman and Deal Leadership framework. The participants described demonstrating leadership capabilities associated with each of the four leadership frames. However, the language used by the clinical specialists/APPs suggested that they work predominantly through the human resource frame. Structural frame capabilities were reported by the clinical specialists/APPs and there were some differences to those reported by the managers. In keeping with the reported leadership capabilities of the physiotherapy managers, the employment of capabilities associated with the political frame varied between participants and symbolic frame capabilities were underused. There are many similarities in the self-reported leadership capabilities of managers and clinical specialists/APPs. However, differences were also noted. Both cohorts of physiotherapy leaders may benefit from specific development programs to develop leadership capabilities associated with the political and symbolic frames.

Advanced Seal Development for Large Industrial Gas Turbines

NASA Technical Reports Server (NTRS)

Chupp, Raymond E.

2006-01-01

Efforts are in progress to develop advanced sealing for large utility industrial gas turbine engines (combustion turbines). Such seals have been under developed for some time for aero gas turbines. It is desired to transition this technology to combustion turbines. Brush seals, film riding face and circumferential seals, and other dynamic and static sealing approaches are being incorporated into gas turbines for aero applications by several engine manufacturers. These seals replace labyrinth or other seals with significantly reduced leakage rates. For utility industrial gas turbines, leakage reduction with advanced sealing can be even greater with the enormous size of the components. Challenges to transitioning technology include: extremely long operating times between overhauls; infrequent but large radial and axial excursions; difficulty in coating larger components; and maintenance, installation, and durability requirements. Advanced sealing is part of the Advanced Turbine Systems (ATS) engine development being done under a cooperative agreement between Westinghouse and the US Department of Energy, Office of Fossil Energy. Seal development focuses on various types of seals in the 501ATS engine both at dynamic and static locations. Each development includes rig testing of candidate designs and subsequent engine validation testing of prototype seals. This presentation gives an update of the ongoing ATS sealing efforts with special emphasis on brush seals.

Developing a Model of Advanced Training to Promote Career Advancement for Certified Genetic Counselors: An Investigation of Expanded Skills, Advanced Training Paths, and Professional Opportunities.

PubMed

Baty, Bonnie J; Trepanier, Angela; Bennett, Robin L; Davis, Claire; Erby, Lori; Hippman, Catriona; Lerner, Barbara; Matthews, Anne; Myers, Melanie F; Robbins, Carol B; Singletary, Claire N

2016-08-01

There are currently multiple paths through which genetic counselors can acquire advanced knowledge and skills. However, outside of continuing education opportunities, there are few formal training programs designed specifically for the advanced training of genetic counselors. In the genetic counseling profession, there is currently considerable debate about the paths that should be available to attain advanced skills, as well as the skills that might be needed for practice in the future. The Association of Genetic Counseling Program Directors (AGCPD) convened a national committee, the Committee on Advanced Training for Certified Genetic Counselors (CATCGC), to investigate varied paths to post-master's training and career development. The committee began its work by developing three related grids that view career advancement from the viewpoints of the skills needed to advance (skills), ways to obtain these skills (paths), and existing genetic counselor positions that offer career change or advancement (positions). Here we describe previous work related to genetic counselor career advancement, the charge of the CATCGC, our preliminary work in developing a model through which to view genetic counselor advanced training and career advancement opportunities, and our next steps in further developing and disseminating the model.

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study

PubMed Central

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-01-01

Objectives Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. Setting The setting for this research was a major academic institution in Beijing, China. Participants The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Methods Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Results Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. Conclusion These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate

From orphan drugs to adopted therapies: Advancing C3-targeted intervention to the clinical stage

PubMed Central

Mastellos, Dimitrios C.; Reis, Edimara S.; Yancopoulou, Despina; Hajishengallis, George; Ricklin, Daniel; Lambris, John D.

2016-01-01

Complement dysregulation is increasingly recognized as an important pathogenic driver in a number of clinical disorders. Complement-triggered pathways intertwine with key inflammatory and tissue destructive processes that can either increase the risk of disease or exacerbate pathology in acute or chronic conditions. The launch of the first complement-targeted drugs in the clinic has undeniably stirred the field of complement therapeutic design, providing new insights into complement's contribution to disease pathogenesis and also helping to leverage a more personalized, comprehensive approach to patient management. In this regard, a rapidly expanding toolbox of complement therapeutics is being developed to address unmet clinical needs in several immune-mediated and inflammatory diseases. Elegant approaches employing both surface-directed and fluid-phase inhibitors have exploited diverse components of the complement cascade as putative points of therapeutic intervention. Targeting C3, the central hub of the system, has proven to be a promising strategy for developing biologics as well as small-molecule inhibitors with clinical potential. Complement modulation at the level of C3 has recently shown promise in preclinical primate models, opening up new avenues for therapeutic intervention in both acute and chronic indications fueled by uncontrolled C3 turnover. This review highlights recent developments in the field of complement therapeutics, focusing on C3-directed inhibitors and alternative pathway (AP) regulator-based approaches. Translational perspectives and considerations are discussed, particularly with regard to the structure-guided drug optimization and clinical advancement of a new generation of C3-targeted peptidic inhibitors. PMID:27353192

Advanced Neuroimaging in Traumatic Brain Injury

PubMed Central

Edlow, Brian L.; Wu, Ona

2013-01-01

Advances in structural and functional neuroimaging have occurred at a rapid pace over the past two decades. Novel techniques for measuring cerebral blood flow, metabolism, white matter connectivity, and neural network activation have great potential to improve the accuracy of diagnosis and prognosis for patients with traumatic brain injury (TBI), while also providing biomarkers to guide the development of new therapies. Several of these advanced imaging modalities are currently being implemented into clinical practice, whereas others require further development and validation. Ultimately, for advanced neuroimaging techniques to reach their full potential and improve clinical care for the many civilians and military personnel affected by TBI, it is critical for clinicians to understand the applications and methodological limitations of each technique. In this review, we examine recent advances in structural and functional neuroimaging and the potential applications of these techniques to the clinical care of patients with TBI. We also discuss pitfalls and confounders that should be considered when interpreting data from each technique. Finally, given the vast amounts of advanced imaging data that will soon be available to clinicians, we discuss strategies for optimizing data integration, visualization and interpretation. PMID:23361483

Advances in the clinical development of heat shock protein 90 (Hsp90) inhibitors in cancers

PubMed Central

Jhaveri, Komal; Taldone, Tony; Modi, Shanu; Chiosis, Gabriela

2011-01-01

Hsp90 is an ATP dependent molecular chaperone protein which integrates multiple oncogenic pathways. As such, Hsp90 inhibition is a promising anti-cancer strategy. Several inhibitors that act on Hsp90 by binding to its N-terminal ATP pocket have entered clinical evaluation. Robust pre-clinical data suggested anti-tumor activity in multiple cancer types. Clinically, encouraging results have been demonstrated in melanoma, acute myeloid leukemia, castrate refractory prostate cancer, non-small cell lung carcinoma and multiple myeloma. In breast cancer, proof-of-concept was demonstrated by first generation Hsp90 inhibitors in combination with trastuzumab mainly in human epidermal growth factor receptor 2 (HER2) + metastatic breast cancer. There are a multitude of second generation Hsp90 inhibitors currently under investigation. To date, however, there is no FDA approved Hsp90 inhibitor nor standardized assay to ascertain Hsp90 inhibition. This review summarizes the current status of both first and second generation Hsp90 inhibitors based on their chemical classification and stage of clinical development. It also discusses the pharmacodynamic assays currently implemented in clinic as well as other novel strategies aimed at enhancing the effectiveness of Hsp90 inhibitors. Ultimately, these efforts will aid in maximizing the full potential of this class of agents. PMID:22062686

Urological cancer care pathways: development and use in the context of systematic reviews and clinical practice guidelines.

PubMed

Maclennan, Sara Jane; Maclennan, Steven J; Imamura, Mari; Omar, Muhammad Imran; Vale, Luke; Lam, Thomas; Royle, Pamela; Royle, Justine; Swami, Satchi; Pickard, Rob; McClinton, Sam; Griffiths, T R Leyshon; Dahm, Philipp; N'dow, James

2011-06-01

Making healthcare treatment decisions is a complex process involving a broad stakeholder base including patients, their families, health professionals, clinical practice guideline developers and funders of healthcare. This paper presents a review of a methodology for the development of urological cancer care pathways (UCAN care pathways), which reflects an appreciation of this broad stakeholder base. The methods section includes an overview of the steps in the development of the UCAN care pathways and engagement with clinical content experts and patient groups. The development process is outlined, the uses of the urological cancer care pathways discussed and the implications for clinical practice highlighted. The full set of UCAN care pathways is published in this paper. These include care pathways on localised prostate cancer, locally advanced prostate cancer, metastatic prostate cancer, hormone-resistant prostate cancer, localised renal cell cancer, advanced renal cell cancer, testicular cancer, penile cancer, muscle invasive and metastatic bladder cancer and non-muscle invasive bladder cancer. The process provides a useful framework for improving urological cancer care through evidence synthesis, research prioritisation, stakeholder involvement and international collaboration. Although the focus of this work is urological cancers, the methodology can be applied to all aspects of urology and is transferable to other clinical specialties.

Space Launch System Advanced Development Office, FY 2013 Annual Report

NASA Technical Reports Server (NTRS)

Crumbly, C. M.; Bickley, F. P.; Hueter, U.

2013-01-01

The Advanced Development Office (ADO), part of the Space Launch System (SLS) program, provides SLS with the advanced development needed to evolve the vehicle from an initial Block 1 payload capability of 70 metric tons (t) to an eventual capability Block 2 of 130 t, with intermediary evolution options possible. ADO takes existing technologies and matures them to the point that insertion into the mainline program minimizes risk. The ADO portfolio of tasks covers a broad range of technical developmental activities. The ADO portfolio supports the development of advanced boosters, upper stages, and other advanced development activities benefiting the SLS program. A total of 34 separate tasks were funded by ADO in FY 2013.

NASA's Advanced Radioisotope Power Conversion Technology Development Status

NASA Technical Reports Server (NTRS)

Anderson, David J.; Sankovic, John; Wilt, David; Abelson, Robert D.; Fleurial, Jean-Pierre

2007-01-01

NASA's Advanced Radioisotope Power Systems (ARPS) project is developing the next generation of radioisotope power conversion technologies that will enable future missions that have requirements that cannot be met by either photovoltaic systems or by current radioisotope power systems (RPSs). Requirements of advanced RPSs include high efficiency and high specific power (watts/kilogram) in order to meet future mission requirements with less radioisotope fuel and lower mass so that these systems can meet requirements for a variety of future space applications, including continual operation surface missions, outer-planetary missions, and solar probe. These advances would enable a factor of 2 to 4 decrease in the amount of fuel required to generate electrical power. Advanced RPS development goals also include long-life, reliability, and scalability. This paper provides an update on the contractual efforts under the Radioisotope Power Conversion Technology (RPCT) NASA Research Announcement (NRA) for research and development of Stirling, thermoelectric, and thermophotovoltaic power conversion technologies. The paper summarizes the current RPCT NRA efforts with a brief description of the effort, a status and/or summary of the contractor's key accomplishments, a discussion of upcoming plans, and a discussion of relevant system-level benefits and implications. The paper also provides a general discussion of the benefits from the development of these advanced power conversion technologies and the eventual payoffs to future missions (discussing system benefits due to overall improvements in efficiency, specific power, etc.).

Advances in clinical studies of cardiopulmonary resuscitation

PubMed Central

Chen, Shou-quan

2015-01-01

BACKGROUND: The survival rate of patients after cardiac arrest (CA) remains lower since 2010 International Consensus on Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) was published. In clinical trials, the methods and techniques for CPR have been overly described. This article gives an overview of the progress in methods and techniques for CPR in the past years. DATA SOURCES: Original articles about cardiac arrest and CPR from MEDLINE (PubMed) and relevant journals were searched, and most of them were clinical randomized controlled trials (RCTs). RESULTS: Forty-two articles on methods and techniques of CPR were reviewed, including chest compression and conventional CPR, chest compression depth and speed, defibrillation strategies and priority, mechanical and manual chest compression, advanced airway management, impedance threshold device (ITD) and active compression-decompression (ACD) CPR, epinephrine use, and therapeutic hypothermia. The results of studies and related issues described in the international guidelines had been testified. CONCLUSIONS: Although large multicenter studies on CPR are still difficult to carry out, progress has been made in the past 4 years in the methods and techniques of CPR. The results of this review provide evidences for updating the 2015 international guidelines. PMID:26056537

Policy issues inherent in advanced technology development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Baumann, P.D.

1994-12-31

In the development of advanced technologies, there are several forces which are involved in the success of the development of those technologies. In the overall development of new technologies, a sufficient number of these forces must be present and working in order to have a successful opportunity at developing, introducing and integrating into the marketplace a new technology. This paper discusses some of these forces and how they enter into the equation for success in advanced technology research, development, demonstration, commercialization and deployment. This paper limits itself to programs which are generally governmental funded, which in essence represent most ofmore » the technology development efforts that provide defense, energy and environmental technological products. Along with the identification of these forces are some suggestions as to how changes may be brought about to better ensure success in a long term to attempt to minimize time and financial losses.« less

Self-assessment of clinical nurse mentors as dimensions of professional development and the capability of developing ethical values at nursing students: A correlational research study.

PubMed

Skela-Savič, Brigita; Kiger, Alice

2015-10-01

Providing adequate training for mentors, fostering a positive mentorship culture and establishing the necessary operational procedures for ensuring mentorship quality are the keys to effective clinical mentoring of nursing students. The purpose of the research was to explain different dimensions of clinical mentors' professional development and their capability of developing ethical values in nursing students. A non-experimental quantitative research design was employed. Data were collected by means of a questionnaire administered to the population of clinical mentors (N=143). The total number of questions was 36. Descriptive statistics were used, and bivariate analysis, factor analysis, correlation analysis and linear regression analysis were performed. The professional development of clinical nurse mentors was explained (R(2)=0.256) by career advancement (p=0.000), research and learning (p=0.024) and having a career development plan (p=0.043). Increased professional self-confidence (R(2)=0.188) was explained by career advancement (p=0.000) and the time engaged in record keeping (p=0.028). Responsibility for the development of ethical values in nursing students (R(2)=0.145) was explained by the respondents' level of education (p=0.020) and research and learning (p=0.024). Applying ethical principles and norms into practice (R(2)=0.212) was explained by self-assessed knowledge in ethics (p=0.037) and research and learning (p=0.044). Clinical nurse mentors tended to lack a career development plan, had low work time spent on research and insufficiently participated in education and training activities, which turned out to be significant explanatory factors of their professional development and their capability of developing ethical values in nursing students. The research showed that nursing and higher education managers often failed to assume responsibility for the professional development of clinical nurse mentors. Copyright © 2015 Elsevier Ltd. All rights

Advanced abdominal pregnancy: an increasingly challenging clinical concern for obstetricians

PubMed Central

Huang, Ke; Song, Lei; Wang, Longxia; Gao, Zhiying; Meng, Yuanguang; Lu, Yanping

2014-01-01

Advanced abdominal pregnancy is rare. The low incidence, high misdiagnosis rate, and lack of specific clinical signs and symptoms explain the fact that there are no standard diagnostic and treatment options available for advanced abdominal pregnancy. We managed a case of abdominal pregnancy in a woman who was pregnant for the first time. This case was further complicated by a concurrent singleton intrauterine pregnancy; the twin pregnancy was not detected until 20 weeks of pregnancy. The case was confirmed at 26 weeks gestational age using MRI to be an abdominal combined with intrauterine pregnancy. The pregnancy was terminated by cesarean section at 33 + 5 weeks gestation. We collected the relevant data of the case while reviewing the advanced abdominal pregnancy-related English literature in the Pubmed, Proquest, and OVID databases. We compared and analyzed the pregnancy history, gestational age when the diagnosis was confirmed, the placental colonization position, the course of treatment and surgical processes, related concurrency rate, post-operative drug treatment programs, and follow-up results with the expectation to provide guidance for other physicians who might encounter similar cases. PMID:25337188

Towards knowledge-based systems in clinical practice: development of an integrated clinical information and knowledge management support system.

PubMed

Kalogeropoulos, Dimitris A; Carson, Ewart R; Collinson, Paul O

2003-09-01

Given that clinicians presented with identical clinical information will act in different ways, there is a need to introduce into routine clinical practice methods and tools to support the scientific homogeneity and accountability of healthcare decisions and actions. The benefits expected from such action include an overall reduction in cost, improved quality of care, patient and public opinion satisfaction. Computer-based medical data processing has yielded methods and tools for managing the task away from the hospital management level and closer to the desired disease and patient management level. To this end, advanced applications of information and disease process modelling technologies have already demonstrated an ability to significantly augment clinical decision making as a by-product. The wide-spread acceptance of evidence-based medicine as the basis of cost-conscious and concurrently quality-wise accountable clinical practice suffices as evidence supporting this claim. Electronic libraries are one-step towards an online status of this key health-care delivery quality control environment. Nonetheless, to date, the underlying information and knowledge management technologies have failed to be integrated into any form of pragmatic or marketable online and real-time clinical decision making tool. One of the main obstacles that needs to be overcome is the development of systems that treat both information and knowledge as clinical objects with same modelling requirements. This paper describes the development of such a system in the form of an intelligent clinical information management system: a system which at the most fundamental level of clinical decision support facilitates both the organised acquisition of clinical information and knowledge and provides a test-bed for the development and evaluation of knowledge-based decision support functions.

Advanced Electrical Materials and Components Being Developed

NASA Technical Reports Server (NTRS)

Schwarze, Gene E.

2004-01-01

All aerospace systems require power management and distribution (PMAD) between the energy and power source and the loads. The PMAD subsystem can be broadly described as the conditioning and control of unregulated power from the energy source and its transmission to a power bus for distribution to the intended loads. All power and control circuits for PMAD require electrical components for switching, energy storage, voltage-to-current transformation, filtering, regulation, protection, and isolation. Advanced electrical materials and component development technology is a key technology to increasing the power density, efficiency, reliability, and operating temperature of the PMAD. The primary means to develop advanced electrical components is to develop new and/or significantly improved electronic materials for capacitors, magnetic components, and semiconductor switches and diodes. The next important step is to develop the processing techniques to fabricate electrical and electronic components that exceed the specifications of presently available state-of-the-art components. The NASA Glenn Research Center's advanced electrical materials and component development technology task is focused on the following three areas: 1) New and/or improved dielectric materials for the development of power capacitors with increased capacitance volumetric efficiency, energy density, and operating temperature; 2) New and/or improved high-frequency, high-temperature soft magnetic materials for the development of transformers and inductors with increased power density, energy density, electrical efficiency, and operating temperature; 3) Packaged high-temperature, high-power density, high-voltage, and low-loss SiC diodes and switches.

The role of numerical simulation for the development of an advanced HIFU system

NASA Astrophysics Data System (ADS)

Okita, Kohei; Narumi, Ryuta; Azuma, Takashi; Takagi, Shu; Matumoto, Yoichiro

2014-10-01

High-intensity focused ultrasound (HIFU) has been used clinically and is under clinical trials to treat various diseases. An advanced HIFU system employs ultrasound techniques for guidance during HIFU treatment instead of magnetic resonance imaging in current HIFU systems. A HIFU beam imaging for monitoring the HIFU beam and a localized motion imaging for treatment validation of tissue are introduced briefly as the real-time ultrasound monitoring techniques. Numerical simulations have a great impact on the development of real-time ultrasound monitoring as well as the improvement of the safety and efficacy of treatment in advanced HIFU systems. A HIFU simulator was developed to reproduce ultrasound propagation through the body in consideration of the elasticity of tissue, and was validated by comparison with in vitro experiments in which the ultrasound emitted from the phased-array transducer propagates through the acrylic plate acting as a bone phantom. As the result, the defocus and distortion of the ultrasound propagating through the acrylic plate in the simulation quantitatively agree with that in the experimental results. Therefore, the HIFU simulator accurately reproduces the ultrasound propagation through the medium whose shape and physical properties are well known. In addition, it is experimentally confirmed that simulation-assisted focus control of the phased-array transducer enables efficient assignment of the focus to the target. Simulation-assisted focus control can contribute to design of transducers and treatment planning.

Challenges of advanced hepatocellular carcinoma

PubMed Central

Colagrande, Stefano; Inghilesi, Andrea L; Aburas, Sami; Taliani, Gian G; Nardi, Cosimo; Marra, Fabio

2016-01-01

Hepatocellular carcinoma (HCC) is an aggressive malignancy, resulting as the third cause of death by cancer each year. The management of patients with HCC is complex, as both the tumour stage and any underlying liver disease must be considered conjointly. Although surveillance by imaging, clinical and biochemical parameters is routinely performed, a lot of patients suffering from cirrhosis have an advanced stage HCC at the first diagnosis. Advanced stage HCC includes heterogeneous groups of patients with different clinical condition and radiological features and sorafenib is the only approved treatment according to Barcelona Clinic Liver Cancer. Since the introduction of sorafenib in clinical practice, several phase III clinical trials have failed to demonstrate any superiority over sorafenib in the frontline setting. Loco-regional therapies have also been tested as first line treatment, but their role in advanced HCC is still matter of debate. No single agent or combination therapies have been shown to impact outcomes after sorafenib failure. Therefore this review will focus on the range of experimental therapeutics for patients with advanced HCC and highlights the successes and failures of these treatments as well as areas for future development. Specifics such as dose limiting toxicity and safety profile in patients with liver dysfunction related to the underlying chronic liver disease should be considered when developing therapies in HCC. Finally, robust validated and reproducible surrogate end-points as well as predictive biomarkers should be defined in future randomized trials. PMID:27678348

First Brazilian Consensus of Advanced Prostate Cancer: Recommendations for Clinical Practice.

PubMed

Sasse, Andre Deeke; Wiermann, Evanius Garcia; Herchenhorn, Daniel; Bastos, Diogo Assed; Schutz, Fabio A; Maluf, Fernando Cotait; Coura, George; Morbeck, Igor Alexandre Protzner; Cerci, Juliano J; Smaletz, Oren; Lima, Volney Soares; Adamy, Ari; Campos, Franz Santos de; Carvalhal, Gustavo Franco; Cezar, Leandro Casemiro; Dall'Oglio, Marcos Francisco; Sadi, Marcus Vinicius; Reis, Rodolfo Borges Dos; Nogueira, Lucas

2017-01-01

Prostate cancer still represents a major cause of morbidity, and still about 20% of men with the disease are diagnosed or will progress to the advanced stage without the possibility of curative treatment. Despite the recent advances in scientific and technological knowledge and the availability of new therapies, there is still considerable heterogeneity in the therapeutic approaches for metastatic prostate cancer. This article presents a summary of the I Brazilian Consensus on Advanced Prostate Cancer, conducted by the Brazilian Society of Urology and Brazilian Society of Clinical Oncology. Experts were selected by the medical societies involved. Forty issues regarding controversial issues in advanced disease were previously elaborated. The panel met for consensus, with a threshold established for 2/3 of the participants. The treatment of advanced prostate cancer is complex, due to the existence of a large number of therapies, with different response profiles and toxicities. The panel addressed recommendations on preferred choice of therapies, indicators that would justify their change, and indicated some strategies for better sequencing of treatment in order to maximize the potential for disease control with the available therapeutic arsenal. The lack of consensus on some topics clearly indicates the absence of strong evidence for some decisions. Copyright® by the International Brazilian Journal of Urology.

The clinical impact of recent advances in LC-MS for cancer biomarker discovery and verification

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wang, Hui; Shi, Tujin; Qian, Wei-Jun

2015-12-04

Mass spectrometry-based proteomics has become an indispensable tool in biomedical research with broad applications ranging from fundamental biology, systems biology, and biomarker discovery. Recent advances in LC-MS have made it become a major technology in clinical applications, especially in cancer biomarker discovery and verification. To overcome the challenges associated with the analysis of clinical samples, such as extremely wide dynamic range of protein concentrations in biofluids and the need to perform high throughput and accurate quantification, significant efforts have been devoted to improve the overall performance of LC-MS bases clinical proteomics. In this review, we summarize the recent advances inmore » LC-MS in the aspect of cancer biomarker discovery and quantification, and discuss its potentials, limitations, and future perspectives.« less

The clinical impact of recent advances in LC-MS for cancer biomarker discovery and verification.

PubMed

Wang, Hui; Shi, Tujin; Qian, Wei-Jun; Liu, Tao; Kagan, Jacob; Srivastava, Sudhir; Smith, Richard D; Rodland, Karin D; Camp, David G

2016-01-01

Mass spectrometry (MS) -based proteomics has become an indispensable tool with broad applications in systems biology and biomedical research. With recent advances in liquid chromatography (LC) and MS instrumentation, LC-MS is making increasingly significant contributions to clinical applications, especially in the area of cancer biomarker discovery and verification. To overcome challenges associated with analyses of clinical samples (for example, a wide dynamic range of protein concentrations in bodily fluids and the need to perform high throughput and accurate quantification of candidate biomarker proteins), significant efforts have been devoted to improve the overall performance of LC-MS-based clinical proteomics platforms. Reviewed here are the recent advances in LC-MS and its applications in cancer biomarker discovery and quantification, along with the potentials, limitations and future perspectives.

Improving quality and patient satisfaction in a pediatric resident continuity clinic through advanced access scheduling.

PubMed

Tuli, Sanjeev Y; Thompson, Lindsay A; Ryan, Kathleen A; Srinivas, Ganga L; Fillipps, Donald J; Young, Christopher M; Tuli, Sonal S

2010-06-01

To evaluate the impact of advanced access scheduling in a pediatric residency clinic on resident and patient satisfaction, medical education, practice quality, and efficiency. Residents were assigned to either the advanced access template (10 appointments available to patients and 2 physician overbooks) or the prior template (5 available and 8 overbooks). Outcomes included resident and patient satisfaction, appointment availability, and continuity of care and clinic costs. Patient satisfaction improved in 7 areas (P < .001). Residents in either template did not report an impact on medical education experiences. Significant increases were realized with appointment availability and the number of patients seen. Continuity also increased as the overflow/acute visits decreased (P < .001). Overall costs per visit decreased 22%. Because of the significant improvements in access, continuity, and efficiency, all residents were switched to the advanced access template after completion of the study. Improvement in access to the primary physician has a significant impact on patient satisfaction with health care delivery. This model optimizes the limited time that residents have in continuity clinic, and it has implications for health care delivery quality improvement.

Development and application of neuropsychology in Hong Kong: implications of its value and future advancement.

PubMed

Chan, Agnes S; Sze, Sophia L; Cheung, Mei-Chun; Han, Yvonne M Y

2016-11-01

To review the development, application, and value of neuropsychology, and the standard education and training pathway for neuropsychologists or clinical neuropsychologists in Hong Kong. The information provided here was gathered via a literature review of the status of neuropsychology and the validity of commonly adopted neuropsychological tests in Hong Kong. Additional details were acquired via the internet about local tertiary education curricula and the related requirements, the availability of professional associations for licensure or board certification, and relevant statistics/surveys conducted by the government. Some information about the clinical practice of neuropsychology was collected through personal communication with local clinical psychologists. The development of neuropsychology in Hong Kong over the past 20 years is rapid and productive, given the increasing application of advanced neuroimaging techniques, neuropsychological tests, and opportunities for exchanging up-to-date neuropsychological knowledge and professional training through international conferences, workshops, and seminars. Given that neuropsychology services are often provided by clinical psychologists who are master's degree graduates in clinical psychology, the relatively limited training in neuropsychological knowledge and skills and the lack of division for membership or mandatory registration as a neuropsychologist/clinical neuropsychologist may have an impact on the quality of clinical neuropsychological services and the development of this specialty. These findings signify a need for further improvement or refinement of educational and training pathways for neuropsychologist or clinical neuropsychologist along with the recognition of its value in clinical practice through registration of different disciplines of psychology in Hong Kong.

Advanced Electrical Materials and Components Development: An Update

NASA Technical Reports Server (NTRS)

Schwarze, Gene E.

2005-01-01

The primary means to develop advanced electrical components is to develop new and improved materials for magnetic components (transformers, inductors, etc.), capacitors, and semiconductor switches and diodes. This paper will give an update of the Advanced Power Electronics and Components Technology being developed by the NASA Glenn Research Center for use in future Power Management and Distribution subsystems used in space power systems for spacecraft and lunar and planetary surface power. The initial description and status of this technology program was presented two years ago at the First International Energy Conversion Engineering Conference held at Portsmouth, Virginia, August 2003. The present paper will give a brief background of the previous work reported and a summary of research performed the past several years on soft magnetic materials characterization, dielectric materials and capacitor developments, high quality silicon carbide atomically smooth substrates, and SiC static and dynamic device characterization under elevated temperature conditions. The rationale for and the benefits of developing advanced electrical materials and components for the PMAD subsystem and also for the total power system will also be briefly discussed.

Schedule Risks Due to Delays in Advanced Technology Development

NASA Technical Reports Server (NTRS)

Reeves, John D. Jr.; Kayat, Kamal A.; Lim, Evan

2008-01-01

This paper discusses a methodology and modeling capability that probabilistically evaluates the likelihood and impacts of delays in advanced technology development prior to the start of design, development, test, and evaluation (DDT&E) of complex space systems. The challenges of understanding and modeling advanced technology development considerations are first outlined, followed by a discussion of the problem in the context of lunar surface architecture analysis. The current and planned methodologies to address the problem are then presented along with sample analyses and results. The methodology discussed herein provides decision-makers a thorough understanding of the schedule impacts resulting from the inclusion of various enabling advanced technology assumptions within system design.

Advanced Power Technology Development Activities for Small Satellite Applications

NASA Technical Reports Server (NTRS)

Piszczor, Michael F.; Landis, Geoffrey A.; Miller, Thomas B.; Taylor, Linda M.; Hernandez-Lugo, Dionne; Raffaelle, Ryne; Landi, Brian; Hubbard, Seth; Schauerman, Christopher; Ganter, Mathew;

Advancing description and explanation in clinical linguistics: a legacy of Martin J. Ball.

PubMed

Damico, Jack S; Damico, Holly L; Nelson, Ryan L

2011-11-01

This article asserts the importance of explication of order and disorder in language as a privileged objective of clinical linguistics and service delivery and reviews the contributions of Martin Ball in advancing this agenda.

Development of advanced fuel cell system

NASA Technical Reports Server (NTRS)

Gitlow, B.; Meyer, A. P.; Bell, W. F.; Martin, R. E.

1978-01-01

An experimental program was conducted continuing the development effort to improve the weight, life, and performance characteristics of hydrogen-oxygen alkaline fuel cells for advanced power systems. These advanced technology cells operate with passive water removal which contributes to a lower system weight and extended operating life. Endurance evaluation of two single cells and two, two-cell plaques was continued. Three new test articles were fabricated and tested. A single cell completed 7038 hours of endurance testing. This cell incorporated a Fybex matrix, hybrid-frame, PPF anode, and a 90 Au/10 Pt cathode. This configuration was developed to extend cell life. Two cell plaques with dedicated flow fields and manifolds for all fluids did not exhibit the cell-to-cell electrolyte transfer that limited the operating life of earlier multicell plaques.

Pursuing Improvement in Clinical Reasoning: Development of the Clinical Coaching Interactions Inventory.

PubMed

Jessee, Mary Ann; Tanner, Christine A

2016-09-01

Clinical coaching has been identified as a signature pedagogy in nursing education. Recent findings indicate that clinical coaching interactions in the clinical learning environment fail to engage students in the higher order thinking skills believed to promote clinical reasoning. The Clinical Coaching Interactions Inventory (CCII) was based on evidence of supervisor questioning techniques, the Tanner clinical judgment model, Bloom's Taxonomy, and simulation evaluation tools. Content validity was established with expert assessment, student testing for clarity, and calculation of scale-content validity index/average (S-CVI/Ave). Reliability was established with Kuder-Richardson Formula 20 (KR-20). CVI (S-CVI/Ave) was .91, and KR-20 was .70. The CCII identified differences in clinical coaching behaviors in university faculty supervisors and staff nurse preceptor supervisors. The CCII advances the measurement of clinical coaching interactions from qualitative to quantitative. Ultimately, results from use of this inventory may facilitate the design of prelicensure clinical coaching strategies that promote the improvement of students' clinical reasoning skill. [J Nurs Educ. 2016;55(9):495-504.]. Copyright 2016, SLACK Incorporated.

Clinical Implementation of Integrated Genomic Profiling in Patients with Advanced Cancers.

PubMed

Borad, Mitesh J; Egan, Jan B; Condjella, Rachel M; Liang, Winnie S; Fonseca, Rafael; Ritacca, Nicole R; McCullough, Ann E; Barrett, Michael T; Hunt, Katherine S; Champion, Mia D; Patel, Maitray D; Young, Scott W; Silva, Alvin C; Ho, Thai H; Halfdanarson, Thorvardur R; McWilliams, Robert R; Lazaridis, Konstantinos N; Ramanathan, Ramesh K; Baker, Angela; Aldrich, Jessica; Kurdoglu, Ahmet; Izatt, Tyler; Christoforides, Alexis; Cherni, Irene; Nasser, Sara; Reiman, Rebecca; Cuyugan, Lori; McDonald, Jacquelyn; Adkins, Jonathan; Mastrian, Stephen D; Valdez, Riccardo; Jaroszewski, Dawn E; Von Hoff, Daniel D; Craig, David W; Stewart, A Keith; Carpten, John D; Bryce, Alan H

2016-12-23

DNA focused panel sequencing has been rapidly adopted to assess therapeutic targets in advanced/refractory cancer. Integrated Genomic Profiling (IGP) utilising DNA/RNA with tumour/normal comparisons in a Clinical Laboratory Improvement Amendments (CLIA) compliant setting enables a single assay to provide: therapeutic target prioritisation, novel target discovery/application and comprehensive germline assessment. A prospective study in 35 advanced/refractory cancer patients was conducted using CLIA-compliant IGP. Feasibility was assessed by estimating time to results (TTR), prioritising/assigning putative therapeutic targets, assessing drug access, ascertaining germline alterations, and assessing patient preferences/perspectives on data use/reporting. Therapeutic targets were identified using biointelligence/pathway analyses and interpreted by a Genomic Tumour Board. Seventy-five percent of cases harboured 1-3 therapeutically targetable mutations/case (median 79 mutations of potential functional significance/case). Median time to CLIA-validated results was 116 days with CLIA-validation of targets achieved in 21/22 patients. IGP directed treatment was instituted in 13 patients utilising on/off label FDA approved drugs (n = 9), clinical trials (n = 3) and single patient IND (n = 1). Preliminary clinical efficacy was noted in five patients (two partial response, three stable disease). Although barriers to broader application exist, including the need for wider availability of therapies, IGP in a CLIA-framework is feasible and valuable in selection/prioritisation of anti-cancer therapeutic targets.

Advanced Refrigerator/Freezer Technology Development. Technology Assessment

NASA Technical Reports Server (NTRS)

Gaseor, Thomas; Hunter, Rick; Hamill, Doris

1996-01-01

The NASA Lewis Research Center, through contract with Oceaneering Space Systems, is engaged in a project to develop advanced refrigerator/freezer (R/F) technologies for future Life and Biomedical Sciences space flight missions. The first phase of this project, a technology assessment, has been completed to identify the advanced R/F technologies needed and best suited to meet the requirements for the five R/F classifications specified by Life and Biomedical Science researchers. Additional objectives of the technology assessment were to rank those technologies based on benefit and risk, and to recommend technology development activities that can be accomplished within this project. This report presents the basis, the methodology, and results of the R/F technology assessment, along with technology development recommendations.

Focused development of advanced practice nurse roles for specific patient groups in a Swiss university hospital

PubMed

Spichiger, Elisabeth; Zumstein-Shaha, Maya; Schubert, Maria; Herrmann, Luzia

2018-02-01

Background: To cover future health care needs of the population, new care models are necessary. The development of advanced nursing practice (ANP) offers the opportunity to meet these challenges with novel services. At the Inselspital, Bern University Hospital, ANP services and corresponding advanced practice nurse (APN) roles have been developed since 2011. Purpose: The aim is to develop innovative and evidence based ANP services to supplement health care for specific patient groups and their family members with the goal to improve safety and achieve better outcomes. Methods: Project-based ANP services are developed in close collaboration of clinical departments and the Nursing Development Unit (NDU) of the Directorate of Nursing. Structure, process and outcome data are collected for evaluation. Findings: Currently, five ANP services are established and running, eight more are in the developmental phase. Most services address the long term care of patients with chronic illnesses and their family members. Ten APNs work between 10 % and 80 %, three are leading an ANP-team. APNs work over 50 % in direct clinical practice, primarily in counselling. An ANP network connects APNs and NDU, promoting synergy and exchange. Conclusions: The available resources often constitute a challenge for the development of ANP services. Vital for the long-term success are an adequate extent of the position, the support by department directorate, the conceptual framework that is implemented across the whole hospital, and the development within project structures.

Clinical roundtable monograph: new and emerging treatments for advanced prostate cancer.

PubMed

George, Daniel J; Kantoff, Philip W; Lin, Daniel W

2011-06-01

Historically, the treatment of metastatic castration-resistant prostate cancer (CRPC) has been limited to chemotherapeutic regimens that did not improve patient survival. In 2004, clinical studies began to demonstrate significant improvements in patient outcomes, including overall survival, with docetaxel versus mitoxantrone chemotherapy. Since these pivotal trials, the combination of docetaxel plus prednisone has become a standard of care for patients with metastatic CRPC. However, the limited survival benefit achieved with this regimen prompted several investigations into the development of alternative therapeutic options. Recent advances have now led to an unprecedented number of new drug approvals within the past year, providing many new treatment options for patients with metastatic CRPC. Sipuleucel-T, considered a new paradigm in cancer treatment, is the first such immunotherapeutic agent approved by the US Food and Drug Administration. Other successes include abiraterone acetate, the first androgen biosynthesis inhibitor, and cabazitaxel, a novel microtubule inhibitor, both of which have demonstrated improved survival following docetaxel failure. The bone-targeting agent denosumab, also recently approved in this setting, offers these patients significant improvement in the prevention of skeletal-related events. The data supporting the approval of each of these agents are described in this monograph, as are current approaches in the treatment of metastatic CRPC and ongoing clinical trials of novel treatments and strategies. The experts also discuss several of the issues regarding the introduction of these novel agents into clinical practice for metastatic CRPC patients.

Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

PubMed

Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

2016-02-01

Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

[Advance directives in clinical practice : Living will, healthcare power of attorney and care directive].

PubMed

Hack, J; Buecking, B; Lopez, C L; Ruchholtz, S; Kühne, C A

2017-06-01

In clinical practice, situations continuously occur in which medical professionals and family members are confronted with decisions on whether to extend or limit treatment for severely ill patients in end of life treatment decisions. In these situations, advance directives are helpful tools in decision making according to the wishes of the patient; however, not every patient has made an advance directive and in our experience medical staff as well as patients are often not familiar with these documents. The purpose of this article is therefore to explain the currently available documents (e.g. living will, healthcare power of attorney and care directive) and the possible (legal) applications and limitations in the routine clinical practice.

[Advance directives in clinical practice : Living will, healthcare power of attorney and care directive].

PubMed

Hack, J; Buecking, B; Lopez, C L; Ruchholtz, S; Kühne, C A

2017-02-01

In clinical practice, situations continuously occur in which medical professionals and family members are confronted with decisions on whether to extend or limit treatment for severely ill patients in end of life treatment decisions. In these situations, advance directives are helpful tools in decision making according to the wishes of the patient; however, not every patient has made an advance directive and in our experience medical staff as well as patients are often not familiar with these documents. The purpose of this article is therefore to explain the currently available documents (e.g. living will, healthcare power of attorney and care directive) and the possible (legal) applications and limitations in the routine clinical practice.

[Advance directives in clinical practice : Living will, healthcare power of attorney and care directive].

PubMed

Hack, J; Buecking, B; Lopez, C L; Ruchholtz, S; Kühne, C A

2017-12-01

In clinical practice, situations continuously occur in which medical professionals and family members are confronted with decisions on whether to extend or limit treatment for severely ill patients in end of life treatment decisions. In these situations, advance directives are helpful tools in decision making according to the wishes of the patient; however, not every patient has made an advance directive and in our experience medical staff as well as patients are often not familiar with these documents. The purpose of this article is therefore to explain the currently available documents (e.g. living will, healthcare power of attorney and care directive) and the possible (legal) applications and limitations in the routine clinical practice.

[Advance directives in clinical practice : Living will, healthcare power of attorney and care directive].

PubMed

Hack, J; Buecking, B; Lopez, C L; Ruchholtz, S; Kühne, C A

2017-04-01

In clinical practice, situations continuously occur in which medical professionals and family members are confronted with decisions on whether to extend or limit treatment for severely ill patients in end of life treatment decisions. In these situations, advance directives are helpful tools in decision making according to the wishes of the patient; however, not every patient has made an advance directive and in our experience medical staff as well as patients are often not familiar with these documents. The purpose of this article is therefore to explain the currently available documents (e.g. living will, healthcare power of attorney and care directive) and the possible (legal) applications and limitations in the routine clinical practice.

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research

PubMed Central

Rider, Lisa G.; Dankó, Katalin; Miller, Frederick W.

2016-01-01

Purpose of review Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers’ collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. Recent findings We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Summary Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways. PMID:25225838

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research.

PubMed

Rider, Lisa G; Dankó, Katalin; Miller, Frederick W

2014-11-01

Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers' collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here, we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways.

Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD

PubMed Central

Bazick, Jessica; Donithan, Michele; Neuschwander-Tetri, Brent A.; Kleiner, David; Brunt, Elizabeth M.; Wilson, Laura; Doo, Ed; Lavine, Joel; Tonascia, James

2015-01-01

OBJECTIVE Approximately 18 million people in the U.S. have coexisting type 2 diabetes and nonalcoholic fatty liver disease (NAFLD). It is not known who among these patients has nonalcoholic steatohepatitis (NASH) with advanced fibrosis. Therefore, we aimed to determine factors that are associated with both NASH and advanced fibrosis in patients with diabetes and NAFLD in order to identify who should be prioritized for referral to a hepatologist for further diagnostic evaluation and treatment. RESEARCH DESIGN AND METHODS This study was derived from the NASH Clinical Research Network studies and included 1,249 patients with biopsy-proven NAFLD (including a model development cohort of 346 patients and an independent validation cohort of 100 patients with type 2 diabetes as defined by the American Diabetes Association criteria). Outcome measures were presence of NASH or advanced fibrosis (stage 3 or 4) using cross-validated, by jackknife method, multivariable-adjusted area under the receiver operating characteristic curve (AUROC) and 95% CI. RESULTS The mean ± SD age and BMI of patients with diabetes and NAFLD was 52.5 ± 10.3 years and 35.8 ± 6.8 kg/m2, respectively. The prevalence of NASH and advanced fibrosis was 69.2% and 41.0%, respectively. The model for NASH included white race, BMI, waist, alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, HbA1c, HOMA of insulin resistance, and ferritin with an AUROC of 0.80 (95% CI 0.75–0.84, P = 0.007). The specificity, sensitivity, negative predictive values (NPVs), and positive predictive values (PPVs) were 90.0%, 56.8%, 47.7%, and 93.2%, respectively, and the model correctly classified 67% of patients as having NASH. The model for predicting advanced fibrosis included age, Hispanic ethnicity, BMI, waist-to-hip ratio, hypertension, ALT-to-AST ratio, alkaline phosphatase, isolated abnormal alkaline phosphatase, bilirubin (total and direct), globulin, albumin, serum insulin, hematocrit

Advanced Radioisotope Power Conversion Technology Research and Development

NASA Technical Reports Server (NTRS)

Wong, Wayne A.

2004-01-01

NASA's Radioisotope Power Conversion Technology program is developing next generation power conversion technologies that will enable future missions that have requirements that cannot be met by either the ubiquitous photovoltaic systems or by current Radioisotope Power System (RPS) technology. Performance goals of advanced radioisotope power systems include improvement over the state-of-practice General Purpose Heat Source/Radioisotope Thermoelectric Generator by providing significantly higher efficiency to reduce the number of radioisotope fuel modules, and increase specific power (watts/kilogram). Other Advanced RPS goals include safety, long-life, reliability, scalability, multi-mission capability, resistance to radiation, and minimal interference with the scientific payload. NASA has awarded ten contracts in the technology areas of Brayton, Stirling, Thermoelectric, and Thermophotovoltaic power conversion including five development contracts that deal with more mature technologies and five research contracts. The Advanced RPS Systems Assessment Team includes members from NASA GRC, JPL, DOE and Orbital Sciences whose function is to review the technologies being developed under the ten Radioisotope Power Conversion Technology contracts and assess their relevance to NASA's future missions. Presented is an overview of the ten radioisotope power conversion technology contracts and NASA's Advanced RPS Systems Assessment Team.

Developing a clinical information system: the role of the chief information officer.

PubMed

Glaser, J

1994-11-01

Chief information officers (CIOs) must play a pivotal role in the formation and implementation of a clinical information system, the subset of an organizational information system that deals specifically with support of clinical care activities. Major elements include the applications software, technology and data architecture, databases, and analysis. The organizational structures and processes that manage the development of improvement activities, including the clinical information system itself, are just as vital to the design of an information system as the hardware and software. To develop, sustain, and advance an information infrastructure, the CIO must help establish certain organizational precursors, such as medical staff involvement, experience with quality improvement, and ability to meet data needs. The CIO must then work with the senior administrative and medical leadership in developing a vision for the information system. The CIO must also create new roles and knowledge for information system and medical staff members. Interaction between information services and medical staff is vitally important to the success of a clinical information system. Organizational committees and structures that Brigham and Women's Hospital in Boston put in place to formalize the relationship between information systems and medical staff include the Clinical Initiative Development Program and the Center for Applied Medical Information Systems Research. Improving the clinical management of care and the efficacy of care processes involves complex changes in organizational culture and processes, medical practice and information system applications, technologies, staff, and data.

A Korean perspective on developing a global policy for advance directives.

PubMed

Kim, Soyoon; Hahm, Ki-Hyun; Park, Hyoung Wook; Kang, Hyun Hee; Sohn, Myongsei

2010-03-01

Despite the wide and daunting array of cross-cultural obstacles that the formulation of a global policy on advance directives will clearly pose, the need is equally evident. Specifically, the expansion of medical services driven by medical tourism, just to name one important example, makes this issue urgently relevant. While ensuring consistency across national borders, a global policy will have the additional and perhaps even more important effect of increasing the use of advance directives in clinical settings and enhancing their effectiveness within each country, regardless of where that country's state of the law currently stands. One cross-cultural issue that may represent a major obstacle in formulating, let alone applying, a global policy is whether patient autonomy as the underlying principle for the use of advance directives is a universal norm or a construct of western traditions that must be reconciled with alternative value systems that may place lesser significance on individual choice. A global policy, at a minimum, must emphasize respect for patient autonomy, provision of medical information, limits to the obligations for physicians, and portability. And though the development of a global policy will be no easy task, active engagement in close collaboration with the World Health Organization can make it possible.

NASA Advanced Life Support Technology Testing and Development

NASA Technical Reports Server (NTRS)

Wheeler, Raymond M.

2012-01-01

Prior to 2010, NASA's advanced life support research and development was carried out primarily under the Exploration Life Support Project of NASA's Exploration Systems Mission Directorate. In 2011, the Exploration Life Support Project was merged with other projects covering Fire Prevention/Suppression, Radiation Protection, Advanced Environmental Monitoring and Control, and Thermal Control Systems. This consolidated project was called Life Support and Habitation Systems, which was managed under the Exploration Systems Mission Directorate. In 2012, NASA re-organized major directorates within the agency, which eliminated the Exploration Systems Mission Directorate and created the Office of the Chief Technologist (OCT). Life support research and development is currently conducted within the Office of the Chief Technologist, under the Next Generation Life Support Project, and within the Human Exploration Operation Missions Directorate under several Advanced Exploration System projects. These Advanced Exploration Systems projects include various themes of life support technology testing, including atmospheric management, water management, logistics and waste management, and habitation systems. Food crop testing is currently conducted as part of the Deep Space Habitation (DSH) project within the Advanced Exploration Systems Program. This testing is focused on growing salad crops that could supplement the crew's diet during near term missions.

Advanced Opto-Electronics (LIDAR and Microsensor Development)

NASA Technical Reports Server (NTRS)

Vanderbilt, Vern C. (Technical Monitor); Spangler, Lee H.

2005-01-01

Our overall intent in this aspect of the project were to establish a collaborative effort between several departments at Montana State University for developing advanced optoelectronic technology for advancing the state-of-the-art in optical remote sensing of the environment. Our particular focus was on development of small systems that can eventually be used in a wide variety of applications that might include ground-, air-, and space deployments, possibly in sensor networks. Specific objectives were to: 1) Build a field-deployable direct-detection lidar system for use in measurements of clouds, aerosols, fish, and vegetation; 2) Develop a breadboard prototype water vapor differential absorption lidar (DIAL) system based on highly stable, tunable diode laser technology developed previously at MSU. We accomplished both primary objectives of this project, in developing a field-deployable direct-detection lidar and a breadboard prototype of a water vapor DIAL system. Paper summarizes each of these accomplishments.

Development of Advanced Seals for Industrial Turbine Applications

NASA Astrophysics Data System (ADS)

Chupp, Raymond E.; Aksit, Mahmut F.; Ghasripoor, Farshad; Turnquist, Norman A.; Dinc, Saim; Mortzheim, Jason; Demiroglu, Mehmet

2002-10-01

A critical area being addressed to improve industrial turbine performance is reducing the parasitic leakage flows through the various static and dynamic seals. Implementation of advanced seals into General Electric (GE) industrial turbines has progressed well over the last few years with significant operating performance gains achieved. Advanced static seals have been placed in gas turbine hot gas-path junctions and steam turbine packing ring segment end gaps. Brush seals have significantly decreased labyrinth seal leakages in gas turbine compressors and turbine interstages, steam turbine interstage and end packings, industrial compressor shaft seals, and generator seals. Abradable seals are being developed for blade-tip locations in various turbine locations. This presentation summarizes the status of advanced seal development for industrial turbines at GE.

The Advanced Technology Development Center (ATDC)

NASA Technical Reports Server (NTRS)

Clements, G. R.; Willcoxon, R. (Technical Monitor)

2001-01-01

NASA is building the Advanced Technology Development Center (ATDC) to provide a 'national resource' for the research, development, demonstration, testing, and qualification of Spaceport and Range Technologies. The ATDC will be located at Space Launch Complex 20 (SLC-20) at Cape Canaveral Air Force Station (CCAFS) in Florida. SLC-20 currently provides a processing and launch capability for small-scale rockets; this capability will be augmented with additional ATDC facilities to provide a comprehensive and integrated in situ environment. Examples of Spaceport Technologies that will be supported by ATDC infrastructure include densified cryogenic systems, intelligent automated umbilicals, integrated vehicle health management systems, next-generation safety systems, and advanced range systems. The ATDC can be thought of as a prototype spaceport where industry, government, and academia, in partnership, can work together to improve safety of future space initiatives. The ATDC is being deployed in five separate phases. Major ATDC facilities will include a Liquid Oxygen Area; a Liquid Hydrogen Area, a Liquid Nitrogen Area, and a multipurpose Launch Mount; 'Iron Rocket' Test Demonstrator; a Processing Facility with a Checkout and Control System; and Future Infrastructure Developments. Initial ATDC development will be completed in 2006.

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

PubMed

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-09-18

Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

Advancing the Scientific Foundation for Evidence-Based Practice in Clinical Child and Adolescent Psychology.

PubMed

Roberts, Michael C; Blossom, Jennifer B; Evans, Spencer C; Amaro, Christina M; Kanine, Rebecca M

2017-01-01

Evidence-based practice (EBP) has become a central focus in clinical child and adolescent psychology. As originally defined, EBP in psychology is the integration of the best available research evidence, patient characteristics, and clinical expertise. Although evidence-based perspectives have garnered widespread acceptance in recent years, there has also been some confusion and disagreement about the 3-part definition of EBP, particularly the role of research. In this article, we first provide a brief review of the development of EBP in clinical child and adolescent psychology. Next, we outline the following 4 points to help clarify the understanding of EBP: (a) knowledge should not be confused with epistemic processes, (b) research on clinician and client factors is needed for EBP, (c) research on assessment is needed for EBP, and (d) the 3-part conceptualization of EBP can serve as a useful framework to guide research. Based on these principles, we put forth a slightly revised conceptualization of EBP, in which the role of research is expanded and more clearly operationalized. Finally, based on our review of the literature, we offer illustrative examples of specific directions for future research to advance the evidence base for EBP in clinical child and adolescent psychology.

NASA Advanced Refrigerator/Freezer Technology Development Project Overview

NASA Technical Reports Server (NTRS)

Cairelli, J. E.

1995-01-01

NASA Lewis Research Center (LeRC) has recently initiated a three-year project to develop the advanced refrigerator/freezer (R/F) technologies needed to support future life and biomedical sciences space experiments. Refrigerator/freezer laboratory equipment, most of which needs to be developed, is enabling to about 75 percent of the planned space station life and biomedical science experiments. These experiments will require five different classes of equipment; three storage freezers operating at -20 C, -70 C and less than 183 C, a -70 C freeze-dryer, and a cryogenic (less than 183 C) quick/snap freezer. This project is in response to a survey of cooling system technologies, performed by a team of NASA scientists and engineers. The team found that the technologies, required for future R/F systems to support life and biomedical sciences spaceflight experiments, do not exist at an adequate state of development and concluded that a program to develop the advanced R/F technologies is needed. Limitations on spaceflight system size, mass, and power consumption present a significant challenge in developing these systems. This paper presents some background and a description of the Advanced R/F Technology Development Project, project approach and schedule, general description of the R/F systems, and a review of the major R/F equipment requirements.

Advanced Technology Development for Stirling Convertors

NASA Technical Reports Server (NTRS)

Thieme, Lanny G.; Schreiber, Jeffrey G.

2004-01-01

A high-efficiency Stirling Radioisotope generator (SRG) for use on potential NASA space missions is being developed by the Department of Energy, Lockheed Martin, Stirling Technology Company, and NASA Glenn Research Center. GRC is also developing advanced technology for Stirling converters, aimed at substantially improving the specific power and efficiency of the converter.The status and results to date will be discussed in this paper.

[Application of clinical nursing path in standard management of advanced schistosomiasis patients with splenomegaly].

PubMed

Yang, Liu; Liu, Juan-Juan

2013-04-01

To study the feasibility and effect of clinical nursing path in the standard management of advanced schistosomiasis patients with splenomegaly. A total of 64 advanced schistosomiasis patients with splenomegaly were randomly divided into a routine nursing group (control group) and a clinical nursing pathway group (CNP group), and the postoperative situation, average hospitalization days, cost of hospitalization and the satisfaction of the patients of the 2 groups were compared. The complications, average hospitalization days, costs of hospitalization in the CNP group were significantly decreased compared with those in the control group, and satisfaction rate of the patients in the CNP group increased from 81.25% to 100%. The implementation of CNP effectively reduces the length of hospitalization, costs and complications, and improves the satisfaction of the patients.

A review of Raman spectroscopy advances with an emphasis on clinical translation challenges in oncology

NASA Astrophysics Data System (ADS)

Jermyn, Michael; Desroches, Joannie; Aubertin, Kelly; St-Arnaud, Karl; Madore, Wendy-Julie; De Montigny, Etienne; Guiot, Marie-Christine; Trudel, Dominique; Wilson, Brian C.; Petrecca, Kevin; Leblond, Frederic

2016-12-01

There is an urgent need for improved techniques for disease detection. Optical spectroscopy and imaging technologies have potential for non- or minimally-invasive use in a wide range of clinical applications. The focus here, in vivo Raman spectroscopy (RS), measures inelastic light scattering based on interaction with the vibrational and rotational modes of common molecular bonds in cells and tissue. The Raman ‘signature’ can be used to assess physiological status and can also be altered by disease. This information can supplement existing diagnostic (e.g. radiological imaging) techniques for disease screening and diagnosis, in interventional guidance for identifying disease margins, and in monitoring treatment responses. Using fiberoptic-based light delivery and collection, RS is most easily performed on accessible tissue surfaces, either on the skin, in hollow organs or intra-operatively. The strength of RS lies in the high biochemical information content of the spectra, that characteristically show an array of very narrow peaks associated with specific chemical bonds. This results in high sensitivity and specificity, for example to distinguish malignant or premalignant from normal tissues. A critical issue is that the Raman signal is often very weak, limiting clinical use to point-by-point measurements. However, non-linear techniques using pulsed-laser sources have been developed to enable in vivo Raman imaging. Changes in Raman spectra with disease are often subtle and spectrally distributed, requiring full spectral scanning, together with the use of tissue classification algorithms that must be trained on large numbers of independent measurements. Recent advances in instrumentation and spectral analysis have substantially improved the clinical feasibility of RS, so that it is now being investigated with increased success in a wide range of cancer types and locations, as well as for non-oncological conditions. This review covers recent advances and

Application of next-generation sequencing in clinical oncology to advance personalized treatment of cancer

PubMed Central

Guan, Yan-Fang; Li, Gai-Rui; Wang, Rong-Jiao; Yi, Yu-Ting; Yang, Ling; Jiang, Dan; Zhang, Xiao-Ping; Peng, Yin

2012-01-01

With the development and improvement of new sequencing technology, next-generation sequencing (NGS) has been applied increasingly in cancer genomics research over the past decade. More recently, NGS has been adopted in clinical oncology to advance personalized treatment of cancer. NGS is used to identify novel and rare cancer mutations, detect familial cancer mutation carriers, and provide molecular rationale for appropriate targeted therapy. Compared to traditional sequencing, NGS holds many advantages, such as the ability to fully sequence all types of mutations for a large number of genes (hundreds to thousands) in a single test at a relatively low cost. However, significant challenges, particularly with respect to the requirement for simpler assays, more flexible throughput, shorter turnaround time, and most importantly, easier data analysis and interpretation, will have to be overcome to translate NGS to the bedside of cancer patients. Overall, continuous dedication to apply NGS in clinical oncology practice will enable us to be one step closer to personalized medicine. PMID:22980418

SU-C-BRA-06: Developing Clinical and Quantitative Guidelines for a 4DCT-Ventilation Functional Avoidance Clinical Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vinogradskiy, Y; Waxweiler, T; Diot, Q

have lung function profiles suitable for functional avoidance. Our study used a retrospective evaluation of a large lung cancer patient database to develop the practical aspects of a 4DCT-ventilation functional avoidance clinical trial. (R.C., E.C., T.G.), NIH Research Scientist Development Award K01-CA181292 (R.C.), and State of Colorado Advanced Industries Accelerator Grant (Y.V.)« less

Major clinical research advances in gynecologic cancer in 2014.

PubMed

Suh, Dong Hoon; Lee, Kyung Hun; Kim, Kidong; Kang, Sokbom; Kim, Jae Weon

2015-04-01

In 2014, 9 topics were selected as major advances in clinical research for gynecologic oncology: 2 each in cervical and corpus cancer, 4 in ovarian cancer, and 1 in breast cancer. For cervical cancer, several therapeutic agents showed viable antitumor clinical response in recurrent and metastatic disease: bevacizumab, cediranib, and immunotherapies including human papillomavirus (HPV)-tumor infiltrating lymphocytes and Z-100. The HPV test received FDA approval as the primary screening tool of cervical cancer in women aged 25 and older, based on the results of the ATHENA trial, which suggested that the HPV test was a more sensitive and efficient strategy for cervical cancer screening than methods based solely on cytology. For corpus cancers, results of a phase III Gynecologic Oncology Group (GOG) 249 study of early-stage endometrial cancer with high-intermediate risk factors are followed by the controversial topic of uterine power morcellation in minimally invasive gynecologic surgery. Promising results of phase II studies regarding the effectiveness of olaparib in various ovarian cancer settings are summarized. After a brief review of results from a phase III study on pazopanib maintenance therapy in advanced ovarian cancer, 2 outstanding 2014 ASCO presentations cover the topic of using molecular subtypes in predicting response to bevacizumab. A review of the use of opportunistic bilateral salpingectomy as an ovarian cancer preventive strategy in the general population is presented. Two remarkable studies that discussed the effectiveness of adjuvant ovarian suppression in premenopausal early breast cancer have been selected as the last topics covered in this review.

WE-DE-207A-00: Advances in Image-Guided Neurointerventions-Clinical Pull and Technology Push

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1. Parallels in the evolution of x-ray angiographic systems and devices used for minimally invasive endovascular therapy Charles Strother - DSA, invented by Dr. Charles Mistretta at UW-Madison, was the technology which enabled the development of minimally invasive endovascular procedures. As DSA became widely available and the potential benefits for accessing the cerebral vasculature from an endovascular approach began to be apparent, industry began efforts to develop tools for use in these procedures. Along with development of catheters, embolic materials, pushable coils and the GDC coils there was simultaneous development and improvement of 2D DSA image quality and the introductionmore » of 3D DSA. Together, these advances resulted in an enormous expansion in the scope and numbers of minimally invasive endovascular procedures. The introduction of flat detectors for c-arm angiographic systems in 2002 provided the possibility of the angiographic suite becoming not just a location for vascular imaging where physiological assessments might also be performed. Over the last decade algorithmic and hardware advances have been sufficient to now realize this potential in clinical practice. The selection of patients for endovascular treatments is enhanced by this dual capability. Along with these advances has been a steady reduction in the radiation exposure required so that today, vascular and soft tissue images may be obtained with equal or in many cases less radiation exposure than is the case for comparable images obtained with multi-detector CT. Learning Objectives: To understand the full capabilities of today’s angiographic suite To understand how c-arm cone beam CT soft tissue imaging can be used for assessments of devices, blood flow and perfusion. Advances in real-time x-ray neuro-endovascular image guidance Stephen Rudin - Reacting to the demands on real-time image guidance for ever finer neurovascular interventions, great improvements in imaging chains are

Legal Briefing: Medicare Coverage of Advance Care Planning.

PubMed

Pope, Thaddeus Mason

2015-01-01

This issue's "Legal Briefing" column covers the recent decision by the Centers for Medicare and Medicaid Services (CMS) to expand Medicare coverage of advance care planning, beginning 1 January 2016. Since 2009, most "Legal Briefings" in this journal have covered a wide gamut of judicial, legislative, and regulatory developments concerning a particular topic in clinical ethics. In contrast, this "Legal Briefing" is more narrowly focused on one single legal development. This concentration on Medicare coverage of advance care planning seems warranted. Advance care planning is a frequent subject of articles in JCE. After all, it has long been seen as an important, albeit only partial, solution to a significant range of big problems in clinical ethics. These problems range from medical futility disputes to decision making for incapacitated patients who have no available legally authorized surrogate. Consequently, expanded Medicare coverage of advance care planning is a potentially seismic development. It may materially reduce both the frequency and severity of key problems in clinical ethics. Since the sociological, medical, and ethical literature on advance care planning is voluminous, I will not even summarize it here. Instead, I focus on Medicare coverage. I proceed, chronologically, in six stages: 1. Prior Medicare Coverage of Advance Care Planning 2. Proposed Expanded Medicare Coverage in 2015 3. Proposed Expanded Medicare Coverage in 2016 4. The Final Rule Expanding Medicare Coverage in 2016 5. Remaining Issues for CMS to Address in 2017 6. Pending Federal Legislation. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

Current technological advances in magnetic resonance with critical impact for clinical diagnosis and therapy.

PubMed

Runge, Val M

2013-12-01

The last 5 years of technological advances with major impact on clinical magnetic resonance (MR) are discussed, with greater emphasis on those that are most recent. These developments have already had a critical positive effect on clinical diagnosis and therapy and presage continued rapid improvements for the next 5 years. This review begins with a discussion of 2 topics that encompass the breadth of MR, in terms of anatomic applications, contrast media, and MR angiography. Subsequently, innovations are discussed by anatomic category, picking the areas with the greatest development, starting with the brain, moving forward to the liver and kidney, and concluding with the musculoskeletal system, breast, and prostate. Two final topics are then considered, which will likely, with time, become independent major fields in their own right, interventional MR and MR positron emission tomography (PET).The next decade will bring a new generation of MR contrast media, with research focused on substantial improvements (>100-fold) in relaxivity (contrast effect), thus providing greater efficacy, safety, and tissue targeting. Magnetic resonance angiography will see major advances because of the use of compressed sensing, in terms of spatial and temporal resolution, with movement away from nondynamic imaging. The breadth of available techniques and tissue contrast has greatly expanded in brain imaging, benefiting both from the introduction of new basic categories of imaging techniques, such as readout-segmented echo planar imaging and 3D fast spin echo imaging with variable flip angles, and from new refinements specific to anatomic areas, such as double inversion recovery and MP2RAGE. Liver imaging has benefited from the development of techniques to easily and rapidly assess lipid, and will see, overall, a marked improvement in the next 5 years from new techniques on the verge of clinical introduction, such as controlled aliasing in parallel imaging results in higher acceleration

Technology readiness levels for advanced nuclear fuels and materials development

DOE PAGES

Carmack, W. J.; Braase, L. A.; Wigeland, R. A.; ...

2016-12-23

The Technology Readiness Level (TRL) process is used to quantitatively assess the maturity of a given technology. It was pioneered by the National Aeronautics and Space Administration (NASA) in the 1980s to develop and deploy new systems for space applications. The process was subsequently adopted by the Department of Defense (DoD) to develop and deploy new technology and systems for defense applications as well as the Department of Energy (DOE) to evaluate the maturity of new technologies in major construction projects. Advanced nuclear fuels and materials development is a critical technology needed for improving the performance and safety of currentmore » and advanced reactors, and ultimately closing the nuclear fuel cycle. Because deployment of new nuclear fuel forms requires a lengthy and expensive research, development, and demonstration program, applying the TRL concept to the advanced fuel development program is very useful as a management, communication and tracking tool. Furthermore, this article provides examples regarding the methods by which TRLs are currently used to assess the maturity of nuclear fuels and materials under development in the DOE Fuel Cycle Research and Development (FCRD) Program within the Advanced Fuels Campaign (AFC).« less

Technology readiness levels for advanced nuclear fuels and materials development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Carmack, W. J.; Braase, L. A.; Wigeland, R. A.

The Technology Readiness Level (TRL) process is used to quantitatively assess the maturity of a given technology. It was pioneered by the National Aeronautics and Space Administration (NASA) in the 1980s to develop and deploy new systems for space applications. The process was subsequently adopted by the Department of Defense (DoD) to develop and deploy new technology and systems for defense applications as well as the Department of Energy (DOE) to evaluate the maturity of new technologies in major construction projects. Advanced nuclear fuels and materials development is a critical technology needed for improving the performance and safety of currentmore » and advanced reactors, and ultimately closing the nuclear fuel cycle. Because deployment of new nuclear fuel forms requires a lengthy and expensive research, development, and demonstration program, applying the TRL concept to the advanced fuel development program is very useful as a management, communication and tracking tool. Furthermore, this article provides examples regarding the methods by which TRLs are currently used to assess the maturity of nuclear fuels and materials under development in the DOE Fuel Cycle Research and Development (FCRD) Program within the Advanced Fuels Campaign (AFC).« less

Center to Advance Palliative Care palliative care clinical care and customer satisfaction metrics consensus recommendations.

PubMed

Weissman, David E; Morrison, R Sean; Meier, Diane E

2010-02-01

Data collection and analysis are vital for strategic planning, quality improvement, and demonstration of palliative care program impact to hospital administrators, private funders and policymakers. Since 2000, the Center to Advance Palliative Care (CAPC) has provided technical assistance to hospitals, health systems and hospices working to start, sustain, and grow nonhospice palliative care programs. CAPC convened a consensus panel in 2008 to develop recommendations for specific clinical and customer metrics that programs should track. The panel agreed on four key domains of clinical metrics and two domains of customer metrics. Clinical metrics include: daily assessment of physical/psychological/spiritual symptoms by a symptom assessment tool; establishment of patient-centered goals of care; support to patient/family caregivers; and management of transitions across care sites. For customer metrics, consensus was reached on two domains that should be tracked to assess satisfaction: patient/family satisfaction, and referring clinician satisfaction. In an effort to ensure access to reliably high-quality palliative care data throughout the nation, hospital palliative care programs are encouraged to collect and report outcomes for each of the metric domains described here.

FRAX(®) Clinical Task Force of the 2010 Joint International Society for Clinical Densitometry & International Osteoporosis Foundation Position Development Conference.

PubMed

McCloskey, Eugene V; Binkley, Neil

2011-01-01

The World Health Organization fracture risk assessment tool, FRAX(®), is an advance in clinical care that can assist in clinical decision-making. However, with increasing clinical utilization, numerous questions have arisen regarding how to best estimate fracture risk in an individual patient. Recognizing the need to assist clinicians in optimal use of FRAX(®), the International Osteoporosis Foundation (IOF) in conjunction with the International Society for Clinical Densitometry (ISCD) assembled an international panel of experts that ultimately developed joint Official Positions of the ISCD and IOF advising clinicians regarding FRAX(®) usage. As part of the process, the charge of the FRAX(®) Clinical Task Force was to review and synthesize data surrounding a number of recognized clinical risk factors including rheumatoid arthritis, smoking, alcohol, prior fracture, falls, bone turnover markers and glucocorticoid use. This synthesis was presented to the expert panel and constitutes the data on which the subsequent Official Positions are predicated. A summary of the Clinical Task Force composition and charge is presented here. Copyright © 2011. Published by Elsevier Inc.

BRAF Mutations in Advanced Cancers: Clinical Characteristics and Outcomes

PubMed Central

El-Osta, Hazem; Falchook, Gerald; Tsimberidou, Apostolia; Hong, David; Naing, Aung; Kim, Kevin; Wen, Sijin; Janku, Filip; Kurzrock, Razelle

2011-01-01

Background Oncogenic BRAF mutations have been found in diverse malignancies and activate RAF/MEK/ERK signaling, a critical pathway of tumorigenesis. We examined the clinical characteristics and outcomes of patients with mutant (mut) BRAF advanced cancer referred to phase 1 clinic. Methods We reviewed the records of 80 consecutive patients with mutBRAF advanced malignancies and 149 with wild-type (wt) BRAF (matched by tumor type) referred to the Clinical Center for Targeted Therapy and analyzed their outcome. Results Of 80 patients with mutBRAF advanced cancer, 56 had melanoma, 10 colorectal, 11 papillary thyroid, 2 ovarian and 1 esophageal cancer. Mutations in codon 600 were found in 77 patients (62, V600E; 13, V600K; 1, V600R; 1, unreported). Multivariate analysis showed less soft tissue (Odds ratio (OR) = 0.39, 95%CI: 0.20–0.77, P = 0.007), lung (OR = 0.38, 95%CI: 0.19–0.73, p = 0.004) and retroperitoneal metastases (OR = 0.34, 95%CI: 0.13–0.86, p = 0.024) and more brain metastases (OR = 2.05, 95%CI: 1.02–4.11, P = 0.043) in patients with mutBRAF versus wtBRAF. Comparing to the corresponding wtBRAF, mutBRAF melanoma patients had insignificant trend to longer median survival from diagnosis (131 vs. 78 months, p = 0.14), while mutBRAF colorectal cancer patients had an insignificant trend to shorter median survival from diagnosis (48 vs. 53 months, p = 0.22). In melanoma, V600K mutations in comparison to other BRAF mutations were associated with more frequent brain (75% vs. 36.3%, p = 0.02) and lung metastases (91.6% vs. 47.7%, p = 0.007), and shorter time from diagnosis to metastasis and to death (19 vs. 53 months, p = 0.046 and 78 vs. 322 months, p = 0.024 respectively). Treatment with RAF/MEK targeting agents (Hazard ratio (HR) = 0.16, 95%CI: 0.03–0.89, p = 0.037) and any decrease in tumor size after referral (HR = 0.07, 95%CI: 0.015–0.35, p = 0.001) correlated with longer

NREL and Solectria Developing Advanced Photovoltaic Inverters | Energy

Science.gov Websites

Systems Integration Facility | NREL Solectria NREL and Solectria Developing Advanced inverters offer a lot of potential to help with this, and manufacturers like Solectria are developing

Adenoid cystic carcinoma: A review of recent advances, molecular targets, and clinical trials.

PubMed

Dillon, Patrick M; Chakraborty, Samhita; Moskaluk, Christopher A; Joshi, Prashant J; Thomas, Christopher Y

2016-04-01

Adenoid cystic carcinoma (ACC) is a rare tumor of secretory glands. In this study, recent advances in molecular characterization and in therapeutics are reviewed. A search of articles in PubMed and of abstracts from national meetings was performed regarding ACC. Recent genetic analyses found that recurrent chromosome 6:9 translocations in ACC generate an MYB:NFIB gene fusion resulting in overexpression of the MYB oncoprotein. Several other frequent mutations are recently published that may be relevant for drug development. Several trials of targeted drugs are reviewed. Some agents delay tumor progression, but tumor responses remain rare. ACCs have a characteristic chromosomal translocation, but also frequently pick up additional mutations. Clinical research is limited by the rarity and slow growth of ACC. Several ongoing trials are testing agents that inhibit fibroblast growth factor receptor signaling or other signaling pathways. Novel treatments based on the recently sequenced tumor genome are under development. © 2015 Wiley Periodicals, Inc.

Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD.

PubMed

Bazick, Jessica; Donithan, Michele; Neuschwander-Tetri, Brent A; Kleiner, David; Brunt, Elizabeth M; Wilson, Laura; Doo, Ed; Lavine, Joel; Tonascia, James; Loomba, Rohit

2015-07-01

Approximately 18 million people in the U.S. have coexisting type 2 diabetes and nonalcoholic fatty liver disease (NAFLD). It is not known who among these patients has nonalcoholic steatohepatitis (NASH) with advanced fibrosis. Therefore, we aimed to determine factors that are associated with both NASH and advanced fibrosis in patients with diabetes and NAFLD in order to identify who should be prioritized for referral to a hepatologist for further diagnostic evaluation and treatment. This study was derived from the NASH Clinical Research Network studies and included 1,249 patients with biopsy-proven NAFLD (including a model development cohort of 346 patients and an independent validation cohort of 100 patients with type 2 diabetes as defined by the American Diabetes Association criteria). Outcome measures were presence of NASH or advanced fibrosis (stage 3 or 4) using cross-validated, by jackknife method, multivariable-adjusted area under the receiver operating characteristic curve (AUROC) and 95% CI. The mean ± SD age and BMI of patients with diabetes and NAFLD was 52.5 ± 10.3 years and 35.8 ± 6.8 kg/m(2), respectively. The prevalence of NASH and advanced fibrosis was 69.2% and 41.0%, respectively. The model for NASH included white race, BMI, waist, alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, HbA1c, HOMA of insulin resistance, and ferritin with an AUROC of 0.80 (95% CI 0.75-0.84, P = 0.007). The specificity, sensitivity, negative predictive values (NPVs), and positive predictive values (PPVs) were 90.0%, 56.8%, 47.7%, and 93.2%, respectively, and the model correctly classified 67% of patients as having NASH. The model for predicting advanced fibrosis included age, Hispanic ethnicity, BMI, waist-to-hip ratio, hypertension, ALT-to-AST ratio, alkaline phosphatase, isolated abnormal alkaline phosphatase, bilirubin (total and direct), globulin, albumin, serum insulin, hematocrit, international normalized ratio, and platelet count with

Advancing understanding of executive function impairments and psychopathology: bridging the gap between clinical and cognitive approaches

PubMed Central

Snyder, Hannah R.; Miyake, Akira; Hankin, Benjamin L.

2015-01-01

Executive function (EF) is essential for successfully navigating nearly all of our daily activities. Of critical importance for clinical psychological science, EF impairments are associated with most forms of psychopathology. However, despite the proliferation of research on EF in clinical populations, with notable exceptions clinical and cognitive approaches to EF have remained largely independent, leading to failures to apply theoretical and methodological advances in one field to the other field and hindering progress. First, we review the current state of knowledge of EF impairments associated with psychopathology and limitations to the previous research in light of recent advances in understanding and measuring EF. Next, we offer concrete suggestions for improving EF assessment. Last, we suggest future directions, including integrating modern models of EF with state of the art, hierarchical models of dimensional psychopathology as well as translational implications of EF-informed research on clinical science. PMID:25859234

Development and Validation of a Multidisciplinary Mobile Care System for Patients With Advanced Gastrointestinal Cancer: Interventional Observation Study.

PubMed

Soh, Ji Yeong; Cha, Won Chul; Chang, Dong Kyung; Hwang, Ji Hye; Kim, Kihyung; Rha, Miyong; Kwon, Hee

2018-05-07

Mobile health apps have emerged as supportive tools in the management of advanced cancers. However, only a few apps have self-monitoring features, and they are not standardized and validated. This study aimed to develop and validate a multidisciplinary mobile care system with self-monitoring features that can be useful for patients with advanced gastrointestinal cancer. The development of the multidisciplinary mobile health management system was divided into 3 steps. First, the service scope was set up, and the measurement tools were standardized. Second, the service flow of the mobile care system was organized. Third, the mobile app (Life Manager) was developed. The app was developed to achieve 3 major clinical goals: support for quality of life, nutrition, and rehabilitation. Three main functional themes were developed to achieve clinical goals: a to-do list, health education, and in-app chat. Thirteen clinically oriented measures were included: the modified Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events questionnaire, Scored Patient-Generated Subjective Global Assessment (PG-SGA), distress, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, International Physical Activity Questionnaire-Short Form, Low anterior resection syndrome score, satisfaction rate, etc. To validate the system, a prospective observational study was conducted. Patients with gastric cancer or colon cancer undergoing chemotherapy were recruited. We followed the subjects for 12 weeks, and selected clinical measures were taken online and offline. After the development process, a multidisciplinary app, the Life Manager, was launched. For evaluation, 203 patients were recruited for the study, of whom 101 (49.8%) had gastric cancer, and 102 (50.2%) were receiving palliative care. Most patients were in their fifties (35.5%), and 128 (63.1%) were male. Overall, 176 subjects (86.7%) completed the study. Among subjects who

[Application of clinical nursing path integrated with holistic nursing in advanced schistosomiasis patients with ascites].

PubMed

Mei-Zhi, Yuan; Jing-Ru, Sun; Tao, Chen; Xiao-Yu, Zhang; Liang-Cai, He; Jia-Song, Wang

2016-05-12

To evaluate the effect of the clinical nursing path integrated with the holistic nursing on advanced schistosomiasis patients with ascites. A total of 226 advanced schistosomiasis patients with ascites were randomly divided into a control group and an experimental group (113 cases each group). The subjects in the experimental group were nursed by the clinical nursing path integrated with the holistic nursing, while those in the control group were nursed only by the holistic nursing. Then the clinical relevant indexes of the two groups were observed, and the quality of life of the patients before and after hospital discharge was assessed. The improvement rate, satisfaction degree, and awareness rate of health knowledge of the patients in the experiment group were 93.8%, 100% and 97.4%, respectively, which were significantly higher than those of the control group (all P < 0.05). The mortality rate and the complication rate of the patients in the experimental group were 0 and 2.7%, respectively, which were significantly lower than those of the control group (both P < 0.05). In addition, the average hospitalization days and the hospitalization cost of the experiment group were (12.2 ± 0.7) d and (4 725.0 ± 310.1) Yuan respectively, which were less than those of the control group (both P < 0.01). When 6 months after the discharge from hospital, the quality of life of the patients in the experimental group in various fields was significantly better than that of the control group (all P < 0.05). The clinical nursing pathway integrated with holistic nursing can effectively improve the improvement rate and decrease the mortality of the advanced schistosomiasis patients with ascites; meanwhile, it can shorten the hospitalization time and save the hospitalization cost. Therefore, this nursing model is suitable for popularization and application in the treatment and nursing work of the advanced schistosomiasis assistance.

Advanced imaging research and development at DARPA

NASA Astrophysics Data System (ADS)

Dhar, Nibir K.; Dat, Ravi

2012-06-01

Advances in imaging technology have huge impact on our daily lives. Innovations in optics, focal plane arrays (FPA), microelectronics and computation have revolutionized camera design. As a result, new approaches to camera design and low cost manufacturing is now possible. These advances are clearly evident in visible wavelength band due to pixel scaling, improvements in silicon material and CMOS technology. CMOS cameras are available in cell phones and many other consumer products. Advances in infrared imaging technology have been slow due to market volume and many technological barriers in detector materials, optics and fundamental limits imposed by the scaling laws of optics. There is of course much room for improvements in both, visible and infrared imaging technology. This paper highlights various technology development projects at DARPA to advance the imaging technology for both, visible and infrared. Challenges and potentials solutions are highlighted in areas related to wide field-of-view camera design, small pitch pixel, broadband and multiband detectors and focal plane arrays.

Development of advanced space solar dynamic receiver

NASA Astrophysics Data System (ADS)

Abe, Yoshiyuki; Tanaka, Kotaro; Nomura, Osami; Kanari, Katsuhiko; Takahashi, Yoshio; Kamimoto, Masayuki

Work on an advanced solar dynamic receiver is reviewed. The authors first describe the component test of the receiver tube with LiF in metallic containers, which was performed in a closed high-temperature He-Xe loop. They then give the details of the development of composite phase change materials, such as ceramic/molten salts or carbon/molten salts for advanced receiver concepts. As for SiC/LiF composites, the performance test of the receiver component will soon be ready to begin.

Advanced High-Level Waste Glass Research and Development Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Peeler, David K.; Vienna, John D.; Schweiger, Michael J.

2015-07-01

The U.S. Department of Energy Office of River Protection (ORP) has implemented an integrated program to increase the loading of Hanford tank wastes in glass while meeting melter lifetime expectancies and process, regulatory, and product quality requirements. The integrated ORP program is focused on providing a technical, science-based foundation from which key decisions can be made regarding the successful operation of the Hanford Tank Waste Treatment and Immobilization Plant (WTP) facilities. The fundamental data stemming from this program will support development of advanced glass formulations, key process control models, and tactical processing strategies to ensure safe and successful operations formore » both the low-activity waste (LAW) and high-level waste (HLW) vitrification facilities with an appreciation toward reducing overall mission life. The purpose of this advanced HLW glass research and development plan is to identify the near-, mid-, and longer-term research and development activities required to develop and validate advanced HLW glasses and their associated models to support facility operations at WTP, including both direct feed and full pretreatment flowsheets. This plan also integrates technical support of facility operations and waste qualification activities to show the interdependence of these activities with the advanced waste glass (AWG) program to support the full WTP mission. Figure ES-1 shows these key ORP programmatic activities and their interfaces with both WTP facility operations and qualification needs. The plan is a living document that will be updated to reflect key advancements and mission strategy changes. The research outlined here is motivated by the potential for substantial economic benefits (e.g., significant increases in waste throughput and reductions in glass volumes) that will be realized when advancements in glass formulation continue and models supporting facility operations are implemented. Developing and applying

Cancer Pharmacogenomics: Integrating Discoveries in Basic, Clinical and Population Sciences to Advance Predictive Cancer Care

Cancer.gov

Cancer Pharmacogenomics: Integrating Discoveries in Basic, Clinical and Population Sciences to Advance Predictive Cancer Care, a 2010 workshop sponsored by the Epidemiology and Genomics Research Program.

Advanced launch system. Advanced development oxidizer turbopump program

NASA Technical Reports Server (NTRS)

1993-01-01

On May 19, 1989, Pratt & Whitney was awarded contract NAS8-37595 by the National Aeronautics and Space Administration, Marshall Space Flight Center, Huntsville Alabama for an Advanced Development Program (ADP) to design, develop and demonstrate a highly reliable low cost, liquid oxygen turbopump for the Advanced Launch System (ALS). The ALS had an overall goal of reducing the cost of placing payloads in orbit by an order of magnitude. This goal would require a substantial reduction in life cycle costs, with emphasis on recurring costs, compared to current launch vehicles. Engine studies supporting these efforts were made for the Space Transportation Main Engine (STME). The emphasis on low cost required design simplification of components and subsystems such that the ground maintenance and test operations was minimized. The results of the Oxygen Turbopump ADP technology effort would provide data to be used in the STME. Initially the STME baseline was a gas generator cycle engine with a vacuum thrust level of 580,000 lbf. This was later increased to 650,000 lbf and the oxygen turbopump design approach was changed to reflect the new thrust level. It was intended that this ADP program be conducted in two phases. Phase 1, a basic phase, would encompass the preliminary design effort, and Phase II, an optional contract phase to cover design, fabrication and test evaluation of an oxygen turbopump at a component test facility at the NASA John C. Stennis Space Center in Mississippi. The basic phase included preliminary design and analysis, evaluation of low cost concepts, and evaluation of fabrication techniques. The option phase included design of the pump and support hardware, analysis of the final configuration to ensure design integrity, fabrication of hardware to demonstrate low cost, DVS Testing of hardware to verify the design, assembly of the turbopump and full scale turbopump testing. In December 1990, the intent of this ADP to support the design and development was

Advanced launch system. Advanced development oxidizer turbopump program

NASA Astrophysics Data System (ADS)

1993-10-01

On May 19, 1989, Pratt & Whitney was awarded contract NAS8-37595 by the National Aeronautics and Space Administration, Marshall Space Flight Center, Huntsville Alabama for an Advanced Development Program (ADP) to design, develop and demonstrate a highly reliable low cost, liquid oxygen turbopump for the Advanced Launch System (ALS). The ALS had an overall goal of reducing the cost of placing payloads in orbit by an order of magnitude. This goal would require a substantial reduction in life cycle costs, with emphasis on recurring costs, compared to current launch vehicles. Engine studies supporting these efforts were made for the Space Transportation Main Engine (STME). The emphasis on low cost required design simplification of components and subsystems such that the ground maintenance and test operations was minimized. The results of the Oxygen Turbopump ADP technology effort would provide data to be used in the STME. Initially the STME baseline was a gas generator cycle engine with a vacuum thrust level of 580,000 lbf. This was later increased to 650,000 lbf and the oxygen turbopump design approach was changed to reflect the new thrust level. It was intended that this ADP program be conducted in two phases. Phase 1, a basic phase, would encompass the preliminary design effort, and Phase II, an optional contract phase to cover design, fabrication and test evaluation of an oxygen turbopump at a component test facility at the NASA John C. Stennis Space Center in Mississippi. The basic phase included preliminary design and analysis, evaluation of low cost concepts, and evaluation of fabrication techniques. The option phase included design of the pump and support hardware, analysis of the final configuration to ensure design integrity, fabrication of hardware to demonstrate low cost, DVS Testing of hardware to verify the design, assembly of the turbopump and full scale turbopump testing. In December 1990, the intent of this ADP to support the design and development was

Viewing clinical research career development through the lens of social cognitive career theory.

PubMed

Bakken, Lori L; Byars-Winston, Angela; Wang, Min-Fen

2006-02-01

Issues such as, over commitment, insufficient time, and lack of funding, threaten physicians' entry and sustainability in a research career pathway. Social cognitive career theory is presented as a conceptual framework to critically examine the limitations of the National Institutes of Health's (NIH) efforts to promote the career development of physician-scientists. Special attention is given to the unique challenges of promoting this career pathway for women and underrepresented minorities. The authors propose enhanced recommendations for the career development of physician-scientists and research questions for future studies and program development aimed at advancing the nation's efforts to promote clinical research.

Developing a professional poster: four "ps" for advanced practice nurses to consider.

PubMed

Bindon, Susan L; Davenport, Joan M

2013-01-01

Professional posters play an important role in the dissemination of knowledge and the professional development of advanced practice nurses, graduate students, and clinical faculty. Posters should be considered an integral component in communication of professional work in practice, research, and education. The invitation to submit a poster abstract is an important opportunity for clinicians and faculty alike to consider. Though sometimes misperceived as less prestigious than a podium presentation, posters add a unique element to professional and academic events. The argument is made for posters as an equal among scholarly presentation formats. The poster serves as a tremendous opportunity for collaboration between partners and a way to communicate important findings and advertise the presenters' work. For the advanced practice nurse who is a novice in presenting best practice or evidence from research trials, the poster format may be less intimidating while allowing the invaluable sharing of results. Four critical elements of professional poster development are deciding on a clear Purpose, targeting the right People, outlining key steps in the Process, and delivering a memorable Presentation. Using the "4 Ps" as cornerstones for the work of developing, preparing, and delivering the poster to an audience, the authors aim to help organize the entire process into these essential considerations. The poster, as a means of scholarly work, is a viable and essential activity, as interdisciplinary collaboration and sharing of best practice becomes the expectation for all professional development.

Clinical practice: new challenges for the advanced practice nurse.

PubMed

Bartel, J C; Buturusis, B

2000-12-01

This report describes the challenges for advanced practice nurses (APNs) relative to supply and demand issues. The article also includes opportunities with the Balanced Budget Act, physician acceptance of Advanced Practice Nurses, and expanding practice opportunities. The challenges include the nursing shortage (both in nursing students and faculty), the aging of the nursing workforce, and a lag in nursing salaries; increased demand for nursing based on aging baby boomers, increasing patient acuity and technology, and new arenas for practice. The Balanced Budget Act of 1997 provided new opportunities for advanced practice nurses, including enhanced autonomy to provide services and bill independently of physicians. With these changes come new opportunities for advanced practice nurse entrepreneurs in the areas of independent practice, including opportunities to positively impact the health of families and communities in alignment with the Federal government's vision for "Healthy People 2010." As physician acceptance of advanced practice nurses continues to grow and in light of the changes in medical practice and education (residency reduction), opportunities to expand collaborative practice arrangements also exist. APNs are best suited to make the most of these changes. One example of an opportunity for independent practice, a Community Wellness Center, is developed as an entrepreneurial venture benefiting both the APN and the health of a community. Who better than registered nurses (RNs), especially those practicing at the advanced level, can ensure that these opportunities and challenges are addressed in an ethical manner and focused on the needs and health of the community?

Beyond competencies: using a capability framework in developing practice standards for advanced practice nursing.

PubMed

O'Connell, Jane; Gardner, Glenn; Coyer, Fiona

2014-12-01

This paper presents a discussion on the application of a capability framework for advanced practice nursing standards/competencies. There is acceptance that competencies are useful and necessary for definition and education of practice-based professions. Competencies have been described as appropriate for practice in stable environments with familiar problems. Increasingly competencies are being designed for use in the health sector for advanced practice such as the nurse practitioner role. Nurse practitioners work in environments and roles that are dynamic and unpredictable necessitating attributes and skills to practice at advanced and extended levels in both familiar and unfamiliar clinical situations. Capability has been described as the combination of skills, knowledge, values and self-esteem which enables individuals to manage change, be flexible and move beyond competency. A discussion paper exploring 'capability' as a framework for advanced nursing practice standards. Data were sourced from electronic databases as described in the background section. As advanced practice nursing becomes more established and formalized, novel ways of teaching and assessing the practice of experienced clinicians beyond competency are imperative for the changing context of health services. Leading researchers into capability in health care state that traditional education and training in health disciplines concentrates mainly on developing competence. To ensure that healthcare delivery keeps pace with increasing demand and a continuously changing context there is a need to embrace capability as a framework for advanced practice and education. © 2014 John Wiley & Sons Ltd.

Development of a Post-Graduate Year 2 Pharmacy Residency in Clinical Pharmacogenetics

PubMed Central

Hoffman, James M.; Gammal, Roseann S.; Relling, Mary V.; Crews, Kristine R.

2017-01-01

Purpose The structure and development of an innovative clinical pharmacogenetics post-graduate year 2 (PGY2) ASHP-accredited residency program is described. Summary The advent of the era of genomics has left practitioners wondering how to interpret the data obtained from sequencing and genotyping patients. In order to train the next leaders in the area of implementing pharmacogenetics, St. Jude Children’s Research Hospital established the first accredited residency program in clinical pharmacogenetics. The 12-month long PGY2 residency was created in accordance with the ASHP standards for advanced practice residencies. The resident learns to optimize patient outcomes through the expert provision of evidence-based, patient-centered precision medicine as an integral part of an interdisciplinary team. The resident gains hands-on experience in a dynamic environment regarding all aspects of running a clinical pharmacogenetics service. Since the first resident graduated in 2012, the program has graduated one resident each year. Conclusion To fill a need for pharmacists trained in pharmacogenetics, an innovative PGY2 residency in clinical pharmacogenetics was successfully developed. Upon completion of the program, residents are equipped with the clinical skills and necessary experience to drive precision medicine forward and lead the implementation of pharmacogenetics in various healthcare settings. PMID:28274984

Circulating tumor cells: advances in isolation and analysis, and challenges for clinical applications

PubMed Central

Harouaka, Ramdane; Kang, Zhigang; Zheng, Siyang; Cao, Liang

2013-01-01

Circulating tumor cells (CTCs) are rare cancer cells released from tumors into the bloodstream that are thought to have a key role in cancer metastasis. The presence of CTCs has been associated with worse prognosis in several major cancer types, including breast, prostate and colorectal cancer. There is considerable interest in CTC research and technologies for their potential use as cancer biomarkers that may enhance cancer diagnosis and prognosis, facilitate drug development, and improve the treatment of cancer patients. This review provides an update on recent progress in CTC isolation and molecular characterization technologies. Furthermore, the review covers significant advances and limitations in the clinical applications of CTC-based assays for cancer prognosis, response to anti-cancer therapies, and exploratory studies in biomarkers predictive of sensitivity and resistance to cancer therapies. PMID:24134902

Circulating tumor cells: advances in isolation and analysis, and challenges for clinical applications.

PubMed

Harouaka, Ramdane; Kang, Zhigang; Zheng, Si-Yang; Cao, Liang

2014-02-01

Circulating tumor cells (CTCs) are rare cancer cells released from tumors into the bloodstream that are thought to have a key role in cancer metastasis. The presence of CTCs has been associated with worse prognosis in several major cancer types, including breast, prostate and colorectal cancer. There is considerable interest in CTC research and technologies for their potential use as cancer biomarkers that may enhance cancer diagnosis and prognosis, facilitate drug development, and improve the treatment of cancer patients. This review provides an update on recent progress in CTC isolation and molecular characterization technologies. Furthermore, the review covers significant advances and limitations in the clinical applications of CTC-based assays for cancer prognosis, response to anti-cancer therapies, and exploratory studies in biomarkers predictive of sensitivity and resistance to cancer therapies. Published by Elsevier Inc.

Clinical predictors of advanced sellar masses.

PubMed

Rambaldini, Gloria M; Butalia, Sonia; Ezzat, Shereen; Kucharczyk, Walter; Sawka, Anna M

2007-10-01

To identify clinical variables associated with the presence of a structurally advanced sellar mass (ASM). We performed a retrospective study of patients referred for evaluation of suspected new pituitary disease or sellar mass to the Endocrine Oncology Unit of Mount Sinai Hospital in Toronto, Ontario, Canada. By multivariate analysis, we examined predictors of a structurally ASM (a sellar lesion with any of the following characteristics: diameter of >or=1 cm on magnetic resonance imaging [MRI], optic chiasmal compression on MRI, or clinical or biochemical evidence of hypopituitarism). Data from 152 patients were analyzed. Of the 152 sellar masses, 142 (93%) were pituitary adenomas. An ASM was noted in 85 of the 152 patients (56%). In the final multivariate model, male sex (odds ratio [OR], 6.23; 95% confidence interval [CI], 2.84 to 13.56; P<0.001) and self-reported visual field defect (OR, 3.62; 95% CI, 1.07 to 12.25; P = 0.039) were significantly independently associated with the presence of an ASM. The presence of new or changed headaches also tended to be associated with an ASM (OR, 2.11; 95% CI, 0.96 to 4.64; P = 0.063). Age and self-reported galactorrhea were not independently associated with the presence of an ASM and were conditionally removed from the final model. In patients with suspected sellar or pituitary disease, male sex and self-reported visual field defects independently predict the presence of an ASM. New or changed headaches also tend to be related to the presence of an ASM. The presence of predictors of an ASM should prompt expedited sellar MRI and biochemical evaluation.

The opportunities and obstacles in developing a vascular birthmark database for clinical and research use.

PubMed

Sharma, Vishal K; Fraulin, Frankie Og; Harrop, A Robertson; McPhalen, Donald F

2011-01-01

Databases are useful tools in clinical settings. The authors review the benefits and challenges associated with the development and implementation of an efficient electronic database for the multidisciplinary Vascular Birthmark Clinic at the Alberta Children's Hospital, Calgary, Alberta. The content and structure of the database were designed using the technical expertise of a data analyst from the Calgary Health Region. Relevant clinical and demographic data fields were included with the goal of documenting ongoing care of individual patients, and facilitating future epidemiological studies of this patient population. After completion of this database, 10 challenges encountered during development were retrospectively identified. Practical solutions for these challenges are presented. THE CHALLENGES IDENTIFIED DURING THE DATABASE DEVELOPMENT PROCESS INCLUDED: identification of relevant data fields; balancing simplicity and user-friendliness with complexity and comprehensive data storage; database expertise versus clinical expertise; software platform selection; linkage of data from the previous spreadsheet to a new data management system; ethics approval for the development of the database and its utilization for research studies; ensuring privacy and limited access to the database; integration of digital photographs into the database; adoption of the database by support staff in the clinic; and maintaining up-to-date entries in the database. There are several challenges involved in the development of a useful and efficient clinical database. Awareness of these potential obstacles, in advance, may simplify the development of clinical databases by others in various surgical settings.

The efficacy of self-directed modules for clinical learning: advanced competencies in entry-level physical therapy education.

PubMed

Peck, Kirk; Paschal, Karen; Black, Lisa; Nelson, Kelly

2014-01-01

Prior to graduation, students often express an interest to advance clinical and professional skills in teaching, research, administration, and various niche practice areas. The acquisition of advanced education in selected areas of practice is believed to improve employment opportunities, accelerate career advancement including eligibility for professional certifications, and contribute to personal satisfaction in the profession. The purpose of this paper is to (1) describe an innovative model of education, the Directed Practice Experience (DPE) elective, that incorporates a student-initiated learning process designed to achieve student-identified professional goals, and (2) report the outcomes for graduates who have completed the DPE in an entry-level program in physical therapy education. Students who met select criteria were eligible to complete a DPE. Applicants designed a 4- to 6-week clinical education experience consisting of stated rationale for personal and professional growth, examples of leadership and service, and self-directed objectives that are beyond entry-level expectations as measured by the revised Physical Therapist Clinical Performance Instrument, version 2006. Twenty-six students have completed DPEs since 2005. Fifty percent resulted in new academic partnerships. At least 25% of graduates now serve as clinical instructors for the entry-level program. Those who participated in DPEs have also completed post-graduate residencies, attained ABPTS Board certifications, authored peer-reviewed publications, and taught in both PT and residency programs. The DPE model allows qualified students to acquire advanced personal skills and knowledge prior to graduation in areas of professional practice that exceed entry-level expectations. The model is applicable to all CAPTE accredited physical therapy education programs and is especially beneficial for academic programs desiring to form new community partnerships for student clinical education.

Clinical Application Of Advanced Infrared Thermography (IRT) In Locomotor Diseases

NASA Astrophysics Data System (ADS)

Engel, Joachim-Michael

1983-11-01

Locomotor diseases is a wide range of about 450 different illnesses with all different pathologies, clinical and prognostic features and response to treatment. No single method will be able to cover the whole spectrum of local and systemic signs and symptoms. Nevertheless there is a need for objective measurements at the site of disease: clinical examination is often enough depending from subjective estimations and personal experiance of the clinician. Laboratory tests only show the systemic effect of the disease, like inflammation. X-rays are restricted to the detection of structural changes appearing late during the pathological process, even when using different techniques. Here IRT offers several advantages to the clinician as well as to the patient. As a non invasive method it monitors the course of disease at the anatomic site of pathology. Quantitative figures calculated from the thermogram,either taken at steady-state or during dynamic tests, are essential for differential diagnosis and follow-up. Advanced IRT camera systems fulfill all requirements set up for medical thermography recently by the National Bureau of Standards. Although, the user should check his system daily with regard to precision of absolute temperature measurements. Standardisation of recording technique is essential as well,to get reliable results. Ambient conditions must be adapted to the locomotor disease pathology under study. Advanced IRT systems , e.g. ZEISS-IKOTHERM, together with image processing capability and special software, e.g. THERMOTOM package, are valuable tools to the rheumatologist for diagnosing and monitoring locomotor diseases.

Development of advanced thermoelectric materials

NASA Technical Reports Server (NTRS)

1984-01-01

The development of an advanced thermoelectric material for radioisotope thermoelectric generator (RTG) applications is reported. A number of materials were explored. The bulk of the effort, however, was devoted to improving silicon germanium alloys by the addition of gallium phosphide, the synthesis and evaluation of lanthanum chrome sulfide and the formulation of various mixtures of lanthanum sulfide and chrome sulfide. It is found that each of these materials exhibits promise as a thermoelectric material.

Advanced Launch System advanced development oxidizer turbopump program: Technical implementation plan

NASA Technical Reports Server (NTRS)

Ferlita, F.

1989-01-01

The Advanced Launch Systems (ALS) Advanced Development Oxidizer Turbopump Program has designed, fabricated and demonstrated a low cost, highly reliable oxidizer turbopump for the Space Transportation Engine that minimizes the recurring cost for the ALS engines. Pratt and Whitney's (P and W's) plan for integrating the analyses, testing, fabrication, and other program efforts is addressed. This plan offers a comprehensive description of the total effort required to design, fabricate, and test the ALS oxidizer turbopump. The proposed ALS oxidizer turbopump reduces turbopump costs over current designs by taking advantage of design simplicity and state-of-the-art materials and producibility features without compromising system reliability. This is accomplished by selecting turbopump operating conditions that are within known successful operating regions and by using proven manufacturing techniques.

Faculty Development for Institutional Change: Lessons from an Advance Project

ERIC Educational Resources Information Center

Laursen, Sandra; Rocque, Bill

2009-01-01

The ADVANCE Institutional Transformation projects are remarkably diverse in their theories of action and choice of strategies. However, faculty development plays a role in many, and it was the central change strategy chosen by Leadership Education for Advancement and Promotion (LEAP), the 2002-2008 ADVANCE project at the University of Colorado at…

Transcriptomics in cancer diagnostics: developments in technology, clinical research and commercialization.

PubMed

Sager, Monica; Yeat, Nai Chien; Pajaro-Van der Stadt, Stefan; Lin, Charlotte; Ren, Qiuyin; Lin, Jimmy

2015-01-01

Transcriptomic technologies are evolving to diagnose cancer earlier and more accurately to provide greater predictive and prognostic utility to oncologists and patients. Digital techniques such as RNA sequencing are replacing still-imaging techniques to provide more detailed analysis of the transcriptome and aberrant expression that causes oncogenesis, while companion diagnostics are developing to determine the likely effectiveness of targeted treatments. This article examines recent advancements in molecular profiling research and technology as applied to cancer diagnosis, clinical applications and predictions for the future of personalized medicine in oncology.

NASA's Space Launch System Advanced Booster Development

NASA Technical Reports Server (NTRS)

Robinson, Kimberly F.; Crumbly, Christopher M.; May, Todd A.

2014-01-01

The National Aeronautics and Space Administration's (NASA's) Space Launch System (SLS) Program, managed at the Marshall Space Flight Center, is making progress toward delivering a new capability for human space flight and scientific missions beyond Earth orbit. NASA is executing this development within flat budgetary guidelines by using existing engines assets and heritage technology to ready an initial 70 metric ton (t) lift capability for launch in 2017, and then employing a block upgrade approach to evolve a 130-t capability after 2021. A key component of the SLS acquisition plan is a three-phased approach for the first-stage boosters. The first phase is to expedite the 70-t configuration by completing development of the Space Shuttle heritage 5-segment solid rocket boosters (SRBs) for the initial flights of SLS. Since no existing boosters can meet the performance requirements for the 130-t class SLS, the next phases of the strategy focus on the eventual development of advanced boosters with an expected thrust class potentially double the current 5-segment solid rocket booster capability of 3.88 million pounds of thrust each. The second phase in the booster acquisition plan is the Advanced Booster Engineering Demonstration and/or Risk Reduction (ABEDRR) effort, for which contracts were awarded beginning in 2012 after a full and open competition, with a stated intent to reduce risks leading to an affordable advanced booster. NASA has awarded ABEDRR contracts to four industry teams, which are looking into new options for liquid-fuel booster engines, solid-fuel-motor propellants, and composite booster structures. Demonstrations and/or risk reduction efforts were required to be related to a proposed booster concept directly applicable to fielding an advanced booster. This paper will discuss the status of this acquisition strategy and its results toward readying both the 70 t and 130 t configurations of SLS. The third and final phase will be a full and open

Advancements in drug development for diarrhea-predominant irritable bowel syndrome.

PubMed

Dothel, Giovanni; Barbaro, Maria Raffaella; Raschi, Emanuel; Barbara, Giovanni; De Ponti, Fabrizio

2018-03-01

Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common disorder characterized by a complex pathophysiology hampering optimal targeted drug development. Recent advances in our understanding of key underlying mechanisms prompted novel therapeutics including novel pharmacological approaches. Areas covered: This review summarizes the latest advancements in the pipeline of IBS-D drugs focusing on new pharmacological targets, efficacy and safety of medicinal products considering the recent harmonization of regulatory requirements by the FDA and the EMA. Expert opinion: The new 5-HT 3 receptor antagonist ramosetron appears a promising therapeutic approach devoid of significant adverse events, although it is presently unavailable in Western countries, most likely because of the precautionary approach taken by regulatory agencies with this drug class. New pharmacological concepts on full agonists/antagonists, mixed-receptor activity and novel drug targets may streamline the present drug pipeline along with the adherence on new regulatory guidelines on outcome measures. Eluxadoline can be taken as an example of this paradigm shift. It has now been granted marketing authorization for IBS-D on both sides of the Atlantic, but it is still considered as a second-line agent by the NICE. There is still much work to be done to fully cover clinical needs of patients with IBS-D.

Description and evaluation of an initiative to develop advanced practice nurses in mainland China.

PubMed

Wong, Frances Kam Yuet; Peng, Gangyi; Kan, Eva C; Li, Yajie; Lau, Ada T; Zhang, Liying; Leung, Annie F; Liu, Xueqin; Leung, Vilna O; Chen, Weiju; Li, Ming

2010-05-01

This paper describes an initiative to develop Advanced Practice Nurses (APNs) in mainland China and evaluation of the outcomes of the described programme. The pioneer project was an APN postgraduate programme involving 38 students conducted in Guangzhou, China during 2004-2005. Data related to curriculum content and process, student performance, self-reported competence and programme effects were collected. Quantitative data such as demographic data, student performance were analysed using descriptive statistics and the pre and post self-reported practice of competence was compared using chi-square test. Qualitative data such as case reports and interviews were examined using thematic analyses. Reflective journals and case studies revealed the attributes of APNs in managing clinical cases at advanced level, applying theory into practice and exercising evidence-based practice. The relatively modest self-reported practice of competence suggested that the graduates were novice APNs and needed continued development after the completion of the programme. This study reports the experience of an initiative in China and suggests a useful curriculum framework for educating APNs. Copyright 2009 Elsevier Ltd. All rights reserved.

Recent Advances in Biosensor Development for Foodborne Virus Detection

PubMed Central

Neethirajan, Suresh; Ahmed, Syed Rahin; Chand, Rohit; Buozis, John; Nagy, Éva

2017-01-01

Outbreaks of foodborne diseases related to fresh produce have been increasing in North America and Europe. Viral foodborne pathogens are poorly understood, suffering from insufficient awareness and surveillance due to the limits on knowledge, availability, and costs of related technologies and devices. Current foodborne viruses are emphasized and newly emerging foodborne viruses are beginning to attract interest. To face current challenges regarding foodborne pathogens, a point-of-care (POC) concept has been introduced to food testing technology and device. POC device development involves technologies such as microfluidics, nanomaterials, biosensors and other advanced techniques. These advanced technologies, together with the challenges in developing foodborne virus detection assays and devices, are described and analysed in this critical review. Advanced technologies provide a path forward for foodborne virus detection, but more research and development will be needed to provide the level of manufacturing capacity required. PMID:29071193

JEDI for Advanced Users | Jobs and Economic Development Impact Models |

Science.gov Websites

NREL for Advanced Users JEDI for Advanced Users The Jobs and Economic Development Impact (JEDI discussion. Users with more experience with power generation projects and/or economic impact analysis can Economic Analysis provides data for more than 400 economic sectors. Advanced users can refer to these

Clinical development of gene therapy: results and lessons from recent successes

PubMed Central

Kumar, Sandeep RP; Markusic, David M; Biswas, Moanaro; High, Katherine A; Herzog, Roland W

2016-01-01

Therapeutic gene transfer holds the promise of providing lasting therapies and even cures for diseases that were previously untreatable or for which only temporary or suboptimal treatments were available. For some time, clinical gene therapy was characterized by some impressive but rare examples of successes and also several setbacks. However, effective and long-lasting treatments are now being reported from gene therapy trials at an increasing pace. Positive outcomes have been documented for a wide range of genetic diseases (including hematological, immunological, ocular, and neurodegenerative and metabolic disorders) and several types of cancer. Examples include restoration of vision in blind patients, eradication of blood cancers for which all other treatments had failed, correction of hemoglobinopathies and coagulation factor deficiencies, and restoration of the immune system in children born with primary immune deficiency. To date, about 2,000 clinical trials for various diseases have occurred or are in progress, and many more are in the pipeline. Multiple clinical studies reported successful treatments of pediatric patients. Design of gene therapy vectors and their clinical development are advancing rapidly. This article reviews some of the major successes in clinical gene therapy of recent years. PMID:27257611

GSK's antigen-specific cancer immunotherapy programme: pilot results leading to Phase III clinical development.

PubMed

Brichard, Vincent G; Lejeune, Diane

2007-09-27

From the first evidence that the immune system could recognize tumors, different types of tumor antigens have been identified and deeply characterized. Several different approaches aimed at targeting these antigens have already been the subject of clinical studies. In this field, the GSK Biologicals' approach relying on recombinant proteins combined with an immunological Adjuvant System in a specific clinical setting, has entertained hopes of developing a new class of well tolerated anti-cancer therapy. This methodology led to promising advances with MAGE-A3 immunotherapy in NSCLC and has the potential to be applied to all tumor types.

Advances in Retinal Prosthetic Research: A Systematic Review of Engineering and Clinical Characteristics of Current Prosthetic Initiatives.

PubMed

Cheng, Derrick L; Greenberg, Paul B; Borton, David A

2017-03-01

To date, reviews of retinal prostheses have focused primarily on devices undergoing human trials in the Western Hemisphere and fail to capture significant advances in materials and engineering research in countries such as Japan and Korea, as well as projects in early stages of development. To address these gaps, this systematic review examines worldwide advances in retinal prosthetic research, evaluates engineering characteristics and clinical progress of contemporary device initiatives, and identifies potential directions for future research in the field of retinal prosthetics. A literature search using PubMed, Google Scholar, and IEEExplore was conducted following the PRISMA Guidelines for Systematic Review. Inclusion criteria were peer-reviewed papers demonstrating progress in human or animal trials and papers discussing the prosthetic engineering design. For each initiative, a description of the device, its engineering considerations, and recent clinical results were provided. Ten prosthetic initiatives met our inclusion criteria and were organized by stimulation location. Of these initiatives, four have recently completed human trials, three are undergoing multi- or single-center human trials, and three are undergoing preclinical animal testing. Only the Argus II (FDA 2013, CE 2011) has obtained FDA approval for use in the United States; the Alpha-IMS (CE 2013) has achieved the highest visual acuity using a Landolt-C test to date and is the only device presently undergoing a multicenter clinical trial. Several distinct approaches to retinal stimulation have been successful in eliciting visual precepts in animals and/or humans. However, many clinical needs are still not met and engineering challenges must be addressed before a retinal prosthesis with the capability to fully and safely restore functional vision can be realized.

Echocardiography and risk prediction in advanced heart failure: incremental value over clinical markers.

PubMed

Agha, Syed A; Kalogeropoulos, Andreas P; Shih, Jeffrey; Georgiopoulou, Vasiliki V; Giamouzis, Grigorios; Anarado, Perry; Mangalat, Deepa; Hussain, Imad; Book, Wendy; Laskar, Sonjoy; Smith, Andrew L; Martin, Randolph; Butler, Javed

2009-09-01

Incremental value of echocardiography over clinical parameters for outcome prediction in advanced heart failure (HF) is not well established. We evaluated 223 patients with advanced HF receiving optimal therapy (91.9% angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, 92.8% beta-blockers, 71.8% biventricular pacemaker, and/or defibrillator use). The Seattle Heart Failure Model (SHFM) was used as the reference clinical risk prediction scheme. The incremental value of echocardiographic parameters for event prediction (death or urgent heart transplantation) was measured by the improvement in fit and discrimination achieved by addition of standard echocardiographic parameters to the SHFM. After a median follow-up of 2.4 years, there were 38 (17.0%) events (35 deaths; 3 urgent transplants). The SHFM had likelihood ratio (LR) chi(2) 32.0 and C statistic 0.756 for event prediction. Left ventricular end-systolic volume, stroke volume, and severe tricuspid regurgitation were independent echocardiographic predictors of events. The addition of these parameters to SHFM improved LR chi(2) to 72.0 and C statistic to 0.866 (P < .001 and P=.019, respectively). Reclassifying the SHFM-predicted risk with use of the echocardiography-added model resulted in improved prognostic separation. Addition of standard echocardiographic variables to the SHFM results in significant improvement in risk prediction for patients with advanced HF.

Phage display-derived human antibodies in clinical development and therapy.

PubMed

Frenzel, André; Schirrmann, Thomas; Hust, Michael

2016-10-01

Over the last 3 decades, monoclonal antibodies have become the most important class of therapeutic biologicals on the market. Development of therapeutic antibodies was accelerated by recombinant DNA technologies, which allowed the humanization of murine monoclonal antibodies to make them more similar to those of the human body and suitable for a broad range of chronic diseases like cancer and autoimmune diseases. In the early 1990s in vitro antibody selection technologies were developed that enabled the discovery of "fully" human antibodies with potentially superior clinical efficacy and lowest immunogenicity. Antibody phage display is the first and most widely used of the in vitro selection technologies. It has proven to be a robust, versatile platform technology for the discovery of human antibodies and a powerful engineering tool to improve antibody properties. As of the beginning of 2016, 6 human antibodies discovered or further developed by phage display were approved for therapy. In 2002, adalimumab (Humira®) became the first phage display-derived antibody granted a marketing approval. Humira® was also the first approved human antibody, and it is currently the best-selling antibody drug on the market. Numerous phage display-derived antibodies are currently under advanced clinical investigation, and, despite the availability of other technologies such as human antibody-producing transgenic mice, phage display has not lost its importance for the discovery and engineering of therapeutic antibodies. Here, we provide a comprehensive overview about phage display-derived antibodies that are approved for therapy or in clinical development. A selection of these antibodies is described in more detail to demonstrate different aspects of the phage display technology and its development over the last 25 years.

Advanced diesel engine component development program, tasks 4-14

NASA Astrophysics Data System (ADS)

Kaushal, Tony S.; Weber, Karen E.

1994-11-01

This report summarizes the Advanced Diesel Engine Component Development (ADECD) Program to develop and demonstrate critical technology needed to advance the heavy-duty low heat rejection engine concept. Major development activities reported are the design, analysis, and fabrication of monolithic ceramic components; vapor phase and solid film lubrication; electrohydraulic valve actuation; and high pressure common rail injection. An advanced single cylinder test bed was fabricated as a laboratory tool in studying these advanced technologies. This test bed simulates the reciprocator for a system having no cooling system, turbo compounding, Rankine bottoming cycle, common rail injection, and variable valve actuation to achieve fuel consumption of 160 g/kW-hr (.26 lb/hp-hr). The advanced concepts were successfully integrated into the test engine. All ceramic components met their functional and reliability requirements. The firedeck, cast-in-place ports, valves, valve guides, piston cap, and piston ring were made from silicon nitride. Breakthroughs required to implement a 'ceramic' engine included the fabrication of air-gap cylinder heads, elimination of compression gaskets, machining of ceramic valve seats within the ceramic firedeck, fabrication of cast-in-place ceramic port liners, implementation of vapor phase lubrication, and elimination of the engine coolant system. Silicon nitride valves were successfully developed to meet several production abuse test requirements and incorporated into the test bed with a ceramic valve guide and solid film lubrication. The ADECD cylinder head features ceramic port shields to increase insulation and exhaust energy recovery. The combustion chamber includes a ceramic firedeck and piston cap. The tribological challenge posed by top ring reversal temperatures of 550 C was met through the development of vapor phase lubrication using tricresyl phosphate at the ring-liner interface. A solenoid-controlled, variable valve actuation system

Advanced diesel engine component development program, tasks 4-14

NASA Technical Reports Server (NTRS)

Kaushal, Tony S.; Weber, Karen E.

1994-01-01

This report summarizes the Advanced Diesel Engine Component Development (ADECD) Program to develop and demonstrate critical technology needed to advance the heavy-duty low heat rejection engine concept. Major development activities reported are the design, analysis, and fabrication of monolithic ceramic components; vapor phase and solid film lubrication; electrohydraulic valve actuation; and high pressure common rail injection. An advanced single cylinder test bed was fabricated as a laboratory tool in studying these advanced technologies. This test bed simulates the reciprocator for a system having no cooling system, turbo compounding, Rankine bottoming cycle, common rail injection, and variable valve actuation to achieve fuel consumption of 160 g/kW-hr (.26 lb/hp-hr). The advanced concepts were successfully integrated into the test engine. All ceramic components met their functional and reliability requirements. The firedeck, cast-in-place ports, valves, valve guides, piston cap, and piston ring were made from silicon nitride. Breakthroughs required to implement a 'ceramic' engine included the fabrication of air-gap cylinder heads, elimination of compression gaskets, machining of ceramic valve seats within the ceramic firedeck, fabrication of cast-in-place ceramic port liners, implementation of vapor phase lubrication, and elimination of the engine coolant system. Silicon nitride valves were successfully developed to meet several production abuse test requirements and incorporated into the test bed with a ceramic valve guide and solid film lubrication. The ADECD cylinder head features ceramic port shields to increase insulation and exhaust energy recovery. The combustion chamber includes a ceramic firedeck and piston cap. The tribological challenge posed by top ring reversal temperatures of 550 C was met through the development of vapor phase lubrication using tricresyl phosphate at the ring-liner interface. A solenoid-controlled, variable valve actuation system

Research for Foreign Advanced Ports for Protection and Development Experience

NASA Astrophysics Data System (ADS)

Zhang, Lu; Tian, Mingjing; Zhao, Junjie; Shou, Youping; Wang, Ning; Qiao, Jianzhe; Li, Guanglou

2018-04-01

Into the twenty-first century, the process globalization of economic and trade is getting faster and faster, As of 2014, China's annual port trading amount topped the world, But in the port of environmental protection sustainable development approach with foreign advanced port environmental management concept has a big gap. Combined with the present situation of modern ports in China. Drawing lessons from foreign advanced environmental protection idea of port, in order to promote the protection of port environment in our country. The experience of protection and development of foreign advanced port environment will be discussed and discussed.

Gaucher disease: clinical profile and therapeutic developments.

PubMed

Cox, Timothy M

2010-12-06

before enzyme therapy, bone marrow transplantation was shown to correct systemic disease in Gaucher patients by supplying a source of competent donor macrophages. As a radical advance on cell- or protein-replacement techniques, contemporary methods for transferring genes to autologous hematopoietic stem cells, and to the brain, merit further exploration. At present, the inflated pharmaceutical niche of Gaucher disease appears to be resilient, but if the remaining unmet needs of patients are to be convincingly addressed and commercial development sustained, courageous scientific investment and clinical experimentation will be needed.

Gaucher disease: clinical profile and therapeutic developments

PubMed Central

Cox, Timothy M

2010-01-01

era before enzyme therapy, bone marrow transplantation was shown to correct systemic disease in Gaucher patients by supplying a source of competent donor macrophages. As a radical advance on cell- or protein-replacement techniques, contemporary methods for transferring genes to autologous hematopoietic stem cells, and to the brain, merit further exploration. At present, the inflated pharmaceutical niche of Gaucher disease appears to be resilient, but if the remaining unmet needs of patients are to be convincingly addressed and commercial development sustained, courageous scientific investment and clinical experimentation will be needed. PMID:21209725

Advanced Stirling Technology Development at NASA Glenn Research Center

NASA Technical Reports Server (NTRS)

Shaltens, Richard K.; Wong, Wayne A.

2007-01-01

The NASA Glenn Research Center has been developing advanced energy-conversion technologies for use with both radioisotope power systems and fission surface power systems for many decades. Under NASA's Science Mission Directorate, Planetary Science Theme, Technology Program, Glenn is developing the next generation of advanced Stirling convertors (ASCs) for use in the Department of Energy/Lockheed Martin Advanced Stirling Radioisotope Generator (ASRG). The next-generation power-conversion technologies require high efficiency and high specific power (watts electric per kilogram) to meet future mission requirements to use less of the Department of Energy's plutonium-fueled general-purpose heat source modules and reduce system mass. Important goals include long-life (greater than 14-yr) reliability and scalability so that these systems can be considered for a variety of future applications and missions including outer-planet missions and continual operation on the surface of Mars. This paper provides an update of the history and status of the ASC being developed for Glenn by Sunpower Inc. of Athens, Ohio.

Advancing beyond the system: telemedicine nurses' clinical reasoning using a computerised decision support system for patients with COPD - an ethnographic study.

PubMed

Barken, Tina Lien; Thygesen, Elin; Söderhamn, Ulrika

2017-12-28

-making with the patient. These factors fostered an in-depth knowledge of the patients and acted as a foundation for the nurses' reasoning process. Nurses' reasoning frequently advanced beyond the computerised decision support system recommendations. Future studies are warranted to develop more accurate algorithms, increase system maturity, and improve the integration of the digital clinical information with clinical experiences, to support telemedicine nurses' reasoning process.

Geometric analysis of the V-Y advancement flap and its clinical applications.

PubMed

Andrades, Patricio R; Calderon, Wilfredo; Leniz, Patricio; Bartel, German; Danilla, Stefan; Benitez, Susana

2005-05-01

Geometry is fundamental in the comprehension of local flap design. The purpose of this study was to discuss the differences between the V-Y advancement flap and other local flaps, understand its geometry, and analyze its clinical applications. The analysis was based on qualitative measurements of an injury, taking into consideration the following dimensions: largest diameter, shortest diameter, and depth. Standardization of the flap design consisted of directing its advancement over the shortest diameter and making the V base match the size of the largest diameter. The flap was analyzed in two planes: the horizontal plane includes the V-Y design and the vertical plane includes the flap pedicle. The height of the flap can be obtained by simple trigonometry, taking into consideration the largest diameter and alpha angle in the horizontal plane. In the vertical plane, where the pedicle and pivot plane are positioned, for known shortest diameter and depth, the final depth of the pivot plane can be calculated using Pythagoras' principles. This analysis was applied to 25 patients with adequate skin coverage at follow-up. A correction factor was added to reduce the overdeepening of the vertical plane calculations. The final concepts for clinical application in the classic deep pedicle V-Y flap design are to calculate the length of the V by modifying the alpha angle and to move the pivot plane deeper to accomplish optimal flap movement. Using these principles, tension-free closure of the Y and appropriate advancement of the flap are obtained.

Developing Clinically Practicable Biomarkers for Autism Spectrum Disorder

ERIC Educational Resources Information Center

McPartland, James C.

2017-01-01

Despite significant advances in understanding the biological bases of autism spectrum disorder (ASD), the field remains primarily reliant on observational and parent report measures of behavior to guide clinical practice, conduct research, and evaluate intervention outcomes. There is a critical need for objective measures to more sensitively and…

Advanced Hydrogen Turbine Development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Joesph Fadok

2008-01-01

the advanced hydrogen turbine that meets the aggressive targets set forth for the advanced hydrogen turbine, including increased rotor inlet temperature (RIT), lower total cooling and leakage air (TCLA) flow, higher pressure ratio, and higher mass flow through the turbine compared to the baseline. Maintaining efficiency with high mass flow Syngas combustion is achieved using a large high AN2 blade 4, which has been identified as a significant advancement beyond the current state-of-the-art. Preliminary results showed feasibility of a rotor system capable of increased power output and operating conditions above the baseline. In addition, several concepts were developed for casing components to address higher operating conditions. Rare earth modified bond coat for the purpose of reducing oxidation and TBC spallation demonstrated an increase in TBC spallation life of almost 40%. The results from Phase 1 identified two TBC compositions which satisfy the thermal conductivity requirements and have demonstrated phase stability up to temperatures of 1850 C. The potential to join alloys using a bonding process has been demonstrated and initial HVOF spray deposition trials were promising. The qualitative ranking of alloys and coatings in environmental conditions was also performed using isothermal tests where significant variations in alloy degradation were observed as a function of gas composition. Initial basic system configuration schematics and working system descriptions have been produced to define key boundary data and support estimation of costs. Review of existing materials in use for hydrogen transportation show benefits or tradeoffs for materials that could be used in this type of applications. Hydrogen safety will become a larger risk than when using natural gas fuel as the work done to date in other areas has shown direct implications for this type of use. Studies were conducted which showed reduced CO{sub 2} and NOx emissions with increased plant efficiency. An

Advanced Small Modular Reactor Economics Model Development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harrison, Thomas J.

2014-10-01

The US Department of Energy Office of Nuclear Energy’s Advanced Small Modular Reactor (SMR) research and development activities focus on four key areas: Developing assessment methods for evaluating advanced SMR technologies and characteristics; and Developing and testing of materials, fuels and fabrication techniques; and Resolving key regulatory issues identified by US Nuclear Regulatory Commission and industry; and Developing advanced instrumentation and controls and human-machine interfaces. This report focuses on development of assessment methods to evaluate advanced SMR technologies and characteristics. Specifically, this report describes the expansion and application of the economic modeling effort at Oak Ridge National Laboratory. Analysis ofmore » the current modeling methods shows that one of the primary concerns for the modeling effort is the handling of uncertainty in cost estimates. Monte Carlo–based methods are commonly used to handle uncertainty, especially when implemented by a stand-alone script within a program such as Python or MATLAB. However, a script-based model requires each potential user to have access to a compiler and an executable capable of handling the script. Making the model accessible to multiple independent analysts is best accomplished by implementing the model in a common computing tool such as Microsoft Excel. Excel is readily available and accessible to most system analysts, but it is not designed for straightforward implementation of a Monte Carlo–based method. Using a Monte Carlo algorithm requires in-spreadsheet scripting and statistical analyses or the use of add-ons such as Crystal Ball. An alternative method uses propagation of error calculations in the existing Excel-based system to estimate system cost uncertainty. This method has the advantage of using Microsoft Excel as is, but it requires the use of simplifying assumptions. These assumptions do not necessarily bring into question the analytical results. In

[Clinical effects for patients with recurrent advanced non-small cell lung cancer treated with icotinib hydrochloride].

PubMed

Nong, Jingying; Qin, Na; Wang, Jinghui; Yang, Xinjie; Zhang, Hui; Wu, Yuhua; Lv, Jialin; Zhang, Quan; Zhang, Shucai

2013-05-01

Icotinib hydrochloride is the third single target EGFR-TKI used in clinical treatment of advanced non-small cell lung cancer (NSCLC). Clinical research reports on its efficacy and survival in patients with Recurrent Advanced NSCLC are still little.The aim of this study is to evaluate the efficacy and survival of Icotinib hydrochloride for patients with advanced non-small cell lung cancer who failed to previous chemotherapy and explore the association of clinical features with the efficacy and survival. The clinical data of 60 NSCLC patients referred to the Beijing Chest Hospital, Capital Medical University from March 2009 to July 2012 were retrospectively analyzed. The overall response rate (ORR) was 45.0% and the disease control rate (DCR) was 80.0%. The median progression-free survival (PFS) time was 6.7 months. RR and PFS in female were superior to male (P=0.014, 0.013, respectively). RR, DCR in 2nd-line subgroup were superior to ≥3rd-line subgroup (P=0.020, 0.024, respectively). RR, DCR and PFS in EGFR mutation carriers were significantly superior to wild-type patients (P=0.006, <0.001, 0.002, respectively). There was no statistical difference in RR and PFS between those age<65 and ≥65 or PS<2 and PS≥2. There was no statistical difference in RR and DCR between exon 19 deletion and exon 21 mutations, while the former had much longer PFS (P=0.020). EGFR mutation and exon 19 deletion are the independent prognostic factors to significantly improve the PFS (P=0.009, 0.012, respectively). The side effects were generally mild and consisted of rash and diarrhea. Icotinib hydrochloride is effective especially in EGFR mutation carriers and well tolerated in patients with recurrent advanced non-small-cell lung cancer.

X-ray phase-contrast imaging of the breast—advances towards clinical implementation

PubMed Central

Herzen, J; Willner, M; Grandl, S; Scherer, K; Bamberg, F; Reiser, M F; Pfeiffer, F; Hellerhoff, K

2014-01-01

Breast cancer constitutes about one-quarter of all cancers and is the leading cause of cancer death in women. To reduce breast cancer mortality, mammographic screening programmes have been implemented in many Western countries. However, these programmes remain controversial because of the associated radiation exposure and the need for improvement in terms of diagnostic accuracy. Phase-contrast imaging is a new X-ray-based technology that has been shown to provide enhanced soft-tissue contrast and improved visualization of cancerous structures. Furthermore, there is some indication that these improvements of image quality can be maintained at reduced radiation doses. Thus, X-ray phase-contrast mammography may significantly contribute to advancements in early breast cancer diagnosis. Feasibility studies of X-ray phase-contrast breast CT have provided images that allow resolution of the fine structure of tissue that can otherwise only be obtained by histology. This implies that X-ray phase-contrast imaging may also lead to the development of entirely new (micro-) radiological applications. This review provides a brief overview of the physical characteristics of this new technology and describes recent developments towards clinical implementation of X-ray phase-contrast imaging of the breast. PMID:24452106

Advances in Basic and Clinical Immunology 2009

PubMed Central

Chinen, Javier; Shearer, William T.

2010-01-01

In 2009, reports on basic and clinical immunology had an increased focus on human disease mechanisms and management. The molecular pathogenesis of familial angioedema associated with estrogen was further explored to find possible factors affecting severity, including polymorphisms in enzymes and receptors related to bradykinin pathways. A placebo-controlled clinical trial of C1INH concentrate in hereditary angioedema patients demonstrated the safety of its use and the efficacy to reduce duration of angioedema attacks. The interaction of innate immunity and adaptive responses was further examined in several reports establishing the significant role of toll-like receptor stimulation for the development of optimal specific antibody responses. The 2009 update of the classification of primary immunodeficiencies introduced over 15 new genetic defects related to the immune response, including DOCK8 mutations responsible for the autosomal recessive form of the hyper IgE syndrome. Other reports expanded the clinical spectrum of disease and improved the characterization of conditions such as warts, hypogammaglobulinemia and myelokathexis (WHIM) syndrome, or the occurrence of mucormycosis and Serratia infections in chronic granulomatous disease. The frequent presentation of gastrointestinal disorders in humoral immunodeficiencies was recognized and recommendations for management were reviewed. Clinical research focused in severe combined immunodeficiency included the development and implementation of a state-wide newborn screening program for this condition, a desired goal considering the significant reduction of mortality rate when diagnosis is made early before opportunistic infections occur. PMID:20226292

Advance provision of emergency contraception to young men: An exploratory study in a clinic setting.

PubMed

Garbers, Samantha; Bell, D L; Ogaye, K; Marcell, A V; Westhoff, C L; Rosenthal, S L

2018-04-17

To explore the acceptability of advance provision of emergency contraceptive pills (ECPs) to young men seeking health care. For this exploratory study in a clinic setting, we approached young men aged 16-35 to participate in a survey eliciting socio-demographics, sexual and contraceptive history, and knowledge about ECPs. We offered young men advance provision of ECPs and compared characteristics of 126 young men who did and did not accept the ECPs. Most (76%) of the participants accepted advance provision and left with an ECP pack, with even higher proportions among males whose sexual histories were suggestive of increased risk of involvement in an unintended pregnancy. This study holds promise to inform scale up of advance provision of ECPs among young men. Copyright © 2018 Elsevier Inc. All rights reserved.

Clinical Activity of Alectinib in Advanced RET-Rearranged Non-Small Cell Lung Cancer.

PubMed

Lin, Jessica J; Kennedy, Elizabeth; Sequist, Lecia V; Brastianos, Priscilla K; Goodwin, Kelly E; Stevens, Sara; Wanat, Alexandra C; Stober, Lisa L; Digumarthy, Subba R; Engelman, Jeffrey A; Shaw, Alice T; Gainor, Justin F

2016-11-01

Chromosomal rearrangements involving rearranged during transfection gene (RET) occur in 1% to 2% of NSCLCs and may confer sensitivity to rearranged during transfection (RET) inhibitors. Alectinib is an anaplastic lymphoma kinase tyrosine kinase inhibitor (TKI) that also has anti-RET activity in vitro. The clinical activity of alectinib in patients with RET-rearranged NSCLC has not yet been reported. We have described four patients with advanced RET-rearranged NSCLC who were treated with alectinib (600 mg twice daily [n = 3] or 900 mg twice daily [n = 1]) as part of single-patient compassionate use protocols or off-label use of the commercially available drug. Four patients with metastatic RET-rearranged NSCLC were identified. Three of the four had received prior RET TKIs, including cabozantinib and experimental RET inhibitors. In total, we observed two (50%) objective radiographic responses after treatment with alectinib (one confirmed and one unconfirmed), with durations of therapy of 6 months and more than 5 months (treatment ongoing), respectively. Notably, one of these two patients had his dose of alectinib escalated to 900 mg twice daily and had clinical improvement in central nervous system metastases. In addition, one patient (25%) experienced a best response of stable disease lasting approximately 6 weeks (the drug discontinued for toxicity). A fourth patient who was RET TKI-naive had primary progression while receiving alectinib. Alectinib demonstrated preliminary antitumor activity in patients with advanced RET-rearranged NSCLC, most of whom had received prior RET inhibitors. Larger prospective studies with longer follow-up are needed to assess the efficacy of alectinib in RET-rearranged NSCLC and other RET-driven malignancies. In parallel, development of more selective, potent RET TKIs is warranted. Copyright © 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

Meckel-Gruber Syndrome: An Update on Diagnosis, Clinical Management, and Research Advances.

PubMed

Hartill, Verity; Szymanska, Katarzyna; Sharif, Saghira Malik; Wheway, Gabrielle; Johnson, Colin A

2017-01-01

Meckel-Gruber syndrome (MKS) is a lethal autosomal recessive congenital anomaly syndrome caused by mutations in genes encoding proteins that are structural or functional components of the primary cilium. Conditions that are caused by mutations in ciliary genes are collectively termed the ciliopathies, and MKS represents the most severe condition in this group of disorders. The primary cilium is a microtubule-based organelle, projecting from the apical surface of vertebrate cells. It acts as an "antenna" that receives and transduces chemosensory and mechanosensory signals, but also regulates diverse signaling pathways, such as Wnt and Shh, that have important roles during embryonic development. Most MKS proteins localize to a distinct ciliary compartment called the transition zone (TZ) that regulates the trafficking of cargo proteins or lipids. In this review, we provide an up-to-date summary of MKS clinical features, molecular genetics, and clinical diagnosis. MKS has a highly variable phenotype, extreme genetic heterogeneity, and displays allelism with other related ciliopathies such as Joubert syndrome, presenting significant challenges to diagnosis. Recent advances in genetic technology, with the widespread use of multi-gene panels for molecular testing, have significantly improved diagnosis, genetic counseling, and the clinical management of MKS families. These include the description of some limited genotype-phenotype correlations. We discuss recent insights into the molecular basis of disease in MKS, since the functions of some of the relevant ciliary proteins have now been determined. A common molecular etiology appears to be disruption of ciliary TZ structure and function, affecting essential developmental signaling and the regulation of secondary messengers.

Clinical neuropsychology in South Korea.

PubMed

Kim, Myung-Sun; Chey, Jeanyung

2016-11-01

Clinical neuropsychology in South Korea, albeit its relatively short history, has advanced dramatically. We review a brief history and current status of clinical neuropsychology in South Korea. The history, the educational pathway, the training pathway, the certification process, and careers in clinical neuropsychology in South Korea are reviewed. We have reviewed the neuropsychological services, including assessment and treatment, research on neurological and psychiatric populations, and neuropsychology education and the requirements related to education, training, and board examinations of those providing neuropsychological services in South Korea. We also describe how the Korean Society for Neuropsychology Research, the first and only meeting for neuropsychologists in the country established in 1999, has played a major role in how clinical neuropsychology is practiced and developed as a professional field in South Korea. Clinical neuropsychology in South Korea has achieved major progress over just a quarter of a century, and its future is promising in light of the increasing demand for neuropsychological services and advances in neuroscience in the country. Challenges that the community of clinical neuropsychologists are currently facing in South Korea, including formalizing neuropsychological curriculum and training programs and developing advanced credentialing procedures, are discussed.

Advanced Critical Care Practitioners - Practical experience of implementing the Advanced Critical Care Practitioner Faculty of Intensive Care Medicine Curriculum in a London Critical Care Unit.

PubMed

Lee, Geraldine; Gilroy, Jo-Anne; Ritchie, Alistair; Grover, Vimal; Gull, Keetje; Gruber, Pascale

2018-05-01

With a chronic shortage of doctors in intensive care, alternative roles are being explored. One of these is the role of the Advanced Critical Care Practitioner. The Advanced Critical Care Practitioner Curriculum was developed by the Faculty of Intensive Care Medicine and is used to provide a structured programme of training. The Advanced Critical Care Practitioner programme consists of an academic and clinical component. This article outlines a practical approach of how the programme was developed and is currently being delivered at a single institution. This new advanced practice role offers opportunities to fill gaps in the medical workforce, improve continuity of patient care, provide mentoring and training for less experienced staff as well as offering a rewarding clinical role.

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium: Reaching in Partnership for Optimal Orthopaedic Rehabilitation Outcomes

PubMed Central

Stanhope, Steven J.; Wilken, Jason M.; Pruziner, Alison L.; Dearth, Christopher L.; Wyatt, Marilynn; Ziemke, CAPT Gregg W.; Strickland, Rachel; Milbourne, Suzanne A.; Kaufman, Kenton R.

2017-01-01

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium began in September 2011 as a cooperative agreement with the Department of Defense (DoD) Congressionally Directed Medical Research Programs Peer Reviewed Orthopaedic Research Program. A partnership was formed with DoD Military Treatment Facilities (MTFs), U.S. Department of Veterans Affairs (VA) Centers, the National Institutes of Health (NIH), academia, and industry to rapidly conduct innovative, high-impact, and sustainable clinically relevant research. The BADER Consortium has a unique research capacity-building focus that creates infrastructures and strategically connects and supports research teams to conduct multiteam research initiatives primarily led by MTF and VA investigators. BADER relies on strong partnerships with these agencies to strengthen and support orthopaedic rehabilitation research. Its focus is on the rapid forming and execution of projects focused on obtaining optimal functional outcomes for patients with limb loss and limb injuries. The Consortium is based on an NIH research capacity-building model that comprises essential research support components that are anchored by a set of BADER-funded and initiative-launching studies. Through a partnership with the DoD/VA Extremity Trauma and Amputation Center of Excellence, the BADER Consortium’s research initiative-launching program has directly supported the identification and establishment of eight BADER-funded clinical studies. BADER’s Clinical Research Core (CRC) staff, who are embedded within each of the MTFs, have supported an additional 37 non-BADER Consortium-funded projects. Additional key research support infrastructures that expedite the process for conducting multisite clinical trials include an omnibus Cooperative Research and Development Agreement and the NIH Clinical Trials Database. A 2015 Defense Health Board report highlighted the Consortium’s vital role, stating the research capabilities of

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium: Reaching in Partnership for Optimal Orthopaedic Rehabilitation Outcomes.

PubMed

Stanhope, Steven J; Wilken, Jason M; Pruziner, Alison L; Dearth, Christopher L; Wyatt, Marilynn; Ziemke, Gregg W; Strickland, Rachel; Milbourne, Suzanne A; Kaufman, Kenton R

2016-11-01

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium began in September 2011 as a cooperative agreement with the Department of Defense (DoD) Congressionally Directed Medical Research Programs Peer Reviewed Orthopaedic Research Program. A partnership was formed with DoD Military Treatment Facilities (MTFs), U.S. Department of Veterans Affairs (VA) Centers, the National Institutes of Health (NIH), academia, and industry to rapidly conduct innovative, high-impact, and sustainable clinically relevant research. The BADER Consortium has a unique research capacity-building focus that creates infrastructures and strategically connects and supports research teams to conduct multiteam research initiatives primarily led by MTF and VA investigators.BADER relies on strong partnerships with these agencies to strengthen and support orthopaedic rehabilitation research. Its focus is on the rapid forming and execution of projects focused on obtaining optimal functional outcomes for patients with limb loss and limb injuries. The Consortium is based on an NIH research capacity-building model that comprises essential research support components that are anchored by a set of BADER-funded and initiative-launching studies. Through a partnership with the DoD/VA Extremity Trauma and Amputation Center of Excellence, the BADER Consortium's research initiative-launching program has directly supported the identification and establishment of eight BADER-funded clinical studies. BADER's Clinical Research Core (CRC) staff, who are embedded within each of the MTFs, have supported an additional 37 non-BADER Consortium-funded projects. Additional key research support infrastructures that expedite the process for conducting multisite clinical trials include an omnibus Cooperative Research and Development Agreement and the NIH Clinical Trials Database. A 2015 Defense Health Board report highlighted the Consortium's vital role, stating the research capabilities of the Do

Development and Implementation of a Pharmacist-Managed Clinical Pharmacogenetics Service

PubMed Central

Crews, Kristine R.; Cross, Shane J.; McCormick, John N.; Baker, Donald K.; Molinelli, Alejandro R.; Mullins, Richard; Relling, Mary V.; Hoffman, James M.

2011-01-01

Purpose The development and implementation of a pharmacist-managed Clinical Pharmacogenetics service is described. Summary Therapeutic drug monitoring (TDM) is a well-accepted role of the pharmacist. Pharmacogenetics, the study of genetic factors that influence the variability in drug response among patients, is a rapidly evolving discipline that integrates knowledge of pharmacokinetics and pharmacodynamics with modern advances in genetic testing. There is growing evidence for the clinical utility of pharmacogenetics, and pharmacists can play an essential role in the thoughtful application of pharmacogenetics to patient care. A pharmacist-managed Clinical Pharmacogenetics service was designed and implemented. The goal of the service is to provide clinical pharmacogenetic testing for gene products important to the pharmacodynamics of medications used in our patients. The service is modeled after and integrated with an already established Clinical Pharmacokinetics service. All clinical pharmacogenetic test results are first reported to one of the pharmacists, who reviews the result and provides a written consult. The consult includes an interpretation of the result and recommendations for any indicated changes to therapy. In 2009, 136 clinical pharmacogenetic tests were performed, consisting of 66 TPMT tests, 65 CYP2D6 tests, and 5 UGT1A1 tests. Our service has been met with positive clinician feedback. Conclusion Our experience demonstrates the feasibility of the design and function of a pharmacist-managed Clinical Pharmacogenetics service at an academic specialty hospital. The successful implementation of this service highlights the leadership role that pharmacists can take in moving pharmacogenetics from research to patient care, thereby potentially improving patient outcomes. PMID:21200062

Strengthening the Career Development of Clinical Translational Scientist Trainees: A Consensus Statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees

PubMed Central

Meyers, Frederick J.; Begg, Melissa D.; Fleming, Michael; Merchant, Carol

2012-01-01

Abstract  The challenges for scholars committed to successful careers in clinical and translational science are increasingly well recognized. The Education and Career Development (EdCD) of the national Clinical and Translational Science Award consortium gathered thought leaders to propose sustainable solutions and an agenda for future studies that would strengthen the infrastructure across the spectrum of pre‐ and postdoctoral, MD and PhD, scholars. Six consensus statements were prepared that include: (1) the requirement for career development of a qualitatively different investigator; (2) the implications of interdisciplinary science for career advancement including institutional promotion and tenure actions that were developed for discipline‐specific accomplishments; (3) the need for long‐term commitment of institutions to scholars; (4) discipline‐specific curricula are still required but curricula designed to promote team work and interdisciplinary training will promote innovation; (5) PhD trainees have many pathways to career satisfaction and success; and (6) a centralized infrastructure to enhance and reward mentoring is required. Several themes cut across all of the recommendations including team science, innovation, and sustained institutional commitment. Implied themes include an effective and diverse job force and the requirement for a well‐crafted public policy that supports continued investments in science education. Clin Trans Sci 2012; Volume #: 1–6 PMID:22507118

Strengthening the career development of clinical translational scientist trainees: a consensus statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees.

PubMed

Meyers, Frederick J; Begg, Melissa D; Fleming, Michael; Merchant, Carol

2012-04-01

The challenges for scholars committed to successful careers in clinical and translational science are increasingly well recognized. The Education and Career Development (EdCD) of the national Clinical and Translational Science Award consortium gathered thought leaders to propose sustainable solutions and an agenda for future studies that would strengthen the infrastructure across the spectrum of pre- and postdoctoral, MD and PhD, scholars. Six consensus statements were prepared that include: (1) the requirement for career development of a qualitatively different investigator; (2) the implications of interdisciplinary science for career advancement including institutional promotion and tenure actions that were developed for discipline-specific accomplishments; (3) the need for long-term commitment of institutions to scholars; (4) discipline-specific curricula are still required but curricula designed to promote team work and interdisciplinary training will promote innovation; (5) PhD trainees have many pathways to career satisfaction and success; and (6) a centralized infrastructure to enhance and reward mentoring is required. Several themes cut across all of the recommendations including team science, innovation, and sustained institutional commitment. Implied themes include an effective and diverse job force and the requirement for a well-crafted public policy that supports continued investments in science education. © 2012 Wiley Periodicals, Inc.

Recent advances in basic and clinical nanomedicine.

PubMed

Morrow, K John; Bawa, Raj; Wei, Chiming

2007-09-01

Nanomedicine is a global business enterprise. Industry and governments clearly are beginning to envision nanomedicine's enormous potential. A clear definition of nanotechnology is an issue that requires urgent attention. This problem exists because nanotechnology represents a cluster of technologies, each of which may have different characteristics and applications. Although numerous novel nanomedicine-related applications are under development or nearing commercialization, the process of converting basic research in nanomedicine into commercially viable products will be long and difficult. Although realization of the full potential of nanomedicine may be years or decades away, recent advances in nanotechnology-related drug delivery, diagnosis, and drug development are beginning to change the landscape of medicine. Site-specific targeted drug delivery and personalized medicine are just a few concepts that are on the horizon.

The development of advanced manufacturing systems

NASA Astrophysics Data System (ADS)

Doumeingts, Guy; Vallespir, Bruno; Darricau, Didier; Roboam, Michel

Various methods for the design of advanced manufacturing systems (AMSs) are reviewed. The specifications for AMSs and problems inherent in their development are first discussed. Three models, the Computer Aided Manufacturing-International model, the National Bureau of Standards model, and the GRAI model, are considered in detail. Hierarchical modeling tools such as structured analysis and design techniques, Petri nets, and the Icam definition method are used in the development of integrated manufacturing models. Finally, the GRAI method is demonstrated in the design of specifications for the production management system of the Snecma AMS.

Advances in HIV-1 Vaccine Development

PubMed Central

Gao, Yong

2018-01-01

An efficacious HIV-1 vaccine is regarded as the best way to halt the ongoing HIV-1 epidemic. However, despite significant efforts to develop a safe and effective vaccine, the modestly protective RV144 trial remains the only efficacy trial to provide some level of protection against HIV-1 acquisition. This review will outline the history of HIV vaccine development, novel technologies being applied to HIV vaccinology and immunogen design, as well as the studies that are ongoing to advance our understanding of vaccine-induced immune correlates of protection. PMID:29614779

[Clinical Observation of Icotinib Hydrochloride for Advanced Non-small Cell Lung Cancer Patients with EGFR Status Identified].

PubMed

Li, Xi; Qin, Na; Wang, Jinghui; Yang, Xinjie; Zhang, Xinyong; Lv, Jialin; Wu, Yuhua; Zhang, Hui; Nong, Jingying; Zhang, Quan; Zhang, Shucai

2015-12-01

Icotinib is the first self-developed small molecular drug in China for targeted therapy of lung cancer. Compared to the other two commercially available epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, gefitinib and erlotinib, icotinib is similar to them in chemical structure, mechanism of activity and therapeutic effects. To explore the efficacy and side effects of icotinib hydrochloride in the treatment of the advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation and wild-type. Patients with advanced NSCLC who were treated with icotinib hydrochloride in Beijing Chest Hospital were retrospective analyzed from March 2009 to December 2014. The clinical data of 124 patients (99 with EGFR mutation and 25 with wild type) with advanced NSCLC were enrolled in this study. The patients' overall objective response rate (ORR) was 51.6 % and the disease control rate (DCR) was 79.8%; The patients with EGFR mutation, ORR was 63.6%, DCR was 93.9%. The ORR was 4.0% and the DCR was 24.0% in the wild-type patients. Median progression-free survival (PFS) with icotinib treatment in EGFR mutation patients was 10.5 months and 1.0 month in wild-type patients. The major adverse events were mild skin rash (30.6%) and diarrhea (16.1%). Monotherapy with icotinib hydrochloride is effective and tolerable for the advanced NSCLC EGFR mutation patients.


Advanced technologies impact on compressor design and development: A perspective

NASA Technical Reports Server (NTRS)

Ball, Calvin L.

1989-01-01

A historical perspective of the impact of advanced technologies on compression system design and development for aircraft gas turbine applications is presented. A bright view of the future is projected in which further advancements in compression system technologies will be made. These advancements will have a significant impact on the ability to meet the ever-more-demanding requirements being imposed on the propulsion system for advanced aircraft. Examples are presented of advanced compression system concepts now being studied. The status and potential impact of transitioning from an empirically derived design system to a computationally oriented system are highlighted. A current NASA Lewis Research Center program to enhance this transitioning is described.

New clinical trial explores precision treatment for advanced pancreatic cancer | Center for Cancer Research

Cancer.gov

A new phase II clinical trial to assess the safety and efficacy of a drug called selumetinib for treating patients with advanced pancreatic cancer whose tumors harbor a specific genetic marker has opened at the Center for Cancer Research and is currently recruiting participants. Read more...

Advanced nickel-hydrogen spacecraft battery development

NASA Technical Reports Server (NTRS)

Coates, Dwaine K.; Fox, Chris L.; Standlee, D. J.; Grindstaff, B. K.

1994-01-01

Eagle-Picher currently has several advanced nickel-hydrogen (NiH2) cell component and battery designs under development including common pressure vessel (CPV), single pressure vessel (SPV), and dependent pressure vessel (DPV) designs. A CPV NiH2 battery, utilizing low-cost 64 mm (2.5 in.) cell diameter technology, has been designed and built for multiple smallsat programs, including the TUBSAT B spacecraft which is currently scheduled (24 Nov. 93) for launch aboard a Russian Proton rocket. An advanced 90 mm (3.5 in.) NiH2 cell design is currently being manufactured for the Space Station Freedom program. Prototype 254 mm (10 in.) diameter SPV batteries are currently under construction and initial boilerplate testing has shown excellent results. NiH2 cycle life testing is being continued at Eagle-Picher and IPV cells have currently completed more than 89,000 accelerated LEO cycles at 15% DOD, 49,000 real-time LEO cycles at 30 percent DOD, 37,800 cycles under a real-time LEO profile, 30 eclipse seasons in accelerated GEO, and 6 eclipse seasons in real-time GEO testing at 75 percent DOD maximum. Nickel-metal hydride battery development is continuing for both aerospace and electric vehicle applications. Eagle-Picher has also developed an extensive range of battery evaluation, test, and analysis (BETA) measurement and control equipment and software, based on Hewlett-Packard computerized data acquisition/control hardware.

Interprofessional development and implementation of a pharmacist professional advancement and recognition program.

PubMed

Hager, David; Chmielewski, Eric; Porter, Andrea L; Brzozowski, Sarah; Rough, Steve S; Trapskin, Philip J

2017-11-15

The interprofessional development, implementation, and outcomes of a pharmacist professional advancement and recognition program (PARP) at an academic medical center are described. Limitations of the legacy advancement program, in combination with low rates of employee engagement in peer recognition and professional development, at the UW Health department of pharmacy led to the creation of a task force comprising pharmacists from all practice areas to develop a new pharmacist PARP. Senior leadership within the organization expanded the scope of the project to include an interprofessional work group tasked to develop guidelines and core principles that other professional staff could use to reduce variation across advancement and recognition programs. Key program design elements included a triennial review of performance against advancement standards and the use of peer review to supplement advancement decisions. The primary objective was to meaningfully improve pharmacists' engagement as measured through employee engagement surveys. Secondary outcomes of interest included the results of pharmacist and management satisfaction surveys and the program's impact on the volume and mix of pharmacist professional development activities. Of the 126 eligible pharmacists, 93 participated in the new program. The majority of pharmacists was satisfied with the program. For pharmacists who were advanced as part of the program, meaningful increases in employee engagement scores were observed, and a mean of 95 hours of professional development and quality-improvement activities was documented. Implementation of a PARP helped increase pharmacist engagement through participation in quality-improvement and professional development activities. The program also led to the creation of organizationwide interprofessional guidelines for advancement programs within various healthcare disciplines. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Develop Advanced Nonlinear Signal Analysis Topographical Mapping System

NASA Technical Reports Server (NTRS)

Jong, Jen-Yi

1997-01-01

During the development of the SSME, a hierarchy of advanced signal analysis techniques for mechanical signature analysis has been developed by NASA and AI Signal Research Inc. (ASRI) to improve the safety and reliability for Space Shuttle operations. These techniques can process and identify intelligent information hidden in a measured signal which is often unidentifiable using conventional signal analysis methods. Currently, due to the highly interactive processing requirements and the volume of dynamic data involved, detailed diagnostic analysis is being performed manually which requires immense man-hours with extensive human interface. To overcome this manual process, NASA implemented this program to develop an Advanced nonlinear signal Analysis Topographical Mapping System (ATMS) to provide automatic/unsupervised engine diagnostic capabilities. The ATMS will utilize a rule-based Clips expert system to supervise a hierarchy of diagnostic signature analysis techniques in the Advanced Signal Analysis Library (ASAL). ASAL will perform automatic signal processing, archiving, and anomaly detection/identification tasks in order to provide an intelligent and fully automated engine diagnostic capability. The ATMS has been successfully developed under this contract. In summary, the program objectives to design, develop, test and conduct performance evaluation for an automated engine diagnostic system have been successfully achieved. Software implementation of the entire ATMS system on MSFC's OISPS computer has been completed. The significance of the ATMS developed under this program is attributed to the fully automated coherence analysis capability for anomaly detection and identification which can greatly enhance the power and reliability of engine diagnostic evaluation. The results have demonstrated that ATMS can significantly save time and man-hours in performing engine test/flight data analysis and performance evaluation of large volumes of dynamic test data.

Advanced Monobore Concept, Development of CFEX Self-Expanding Tubular Technology

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jeff Spray

2007-09-30

The Advanced Monobore Concept--CFEX{copyright} Self-Expanding Tubular Technology Development was a successfully executed fundamental research through field demonstration project. This final report is presented as a progression, according to basic technology development steps. For this project, the research and development steps used were: concept development, engineering analysis, manufacturing, testing, demonstration, and technology transfer. The CFEX{copyright} Technology Development--Advanced Monobore Concept Project successfully completed all of the steps for technology development, covering fundamental research, conceptual development, engineering design, advanced-level prototype construction, mechanical testing, and downhole demonstration. Within an approximately two year period, a partially defined, broad concept was evolved into a substantial newmore » technological area for drilling and production engineering applicable a variety of extractive industries--which was also successfully demonstrated in a test well. The demonstration achievement included an actual mono-diameter placement of two self-expanding tubulars. The fundamental result is that an economical and technically proficient means of casing any size of drilling or production well or borehole is indicated as feasible based on the results of the project. Highlighted major accomplishments during the project's Concept, Engineering, Manufacturing, Demonstration, and Technology Transfer phases, are given.« less

Heuristics Applied in the Development of Advanced Space Mission Concepts

NASA Technical Reports Server (NTRS)

Nilsen, Erik N.

1998-01-01

Advanced mission studies are the first step in determining the feasibility of a given space exploration concept. A space scientist develops a science goal in the exploration of space. This may be a new observation method, a new instrument or a mission concept to explore a solar system body. In order to determine the feasibility of a deep space mission, a concept study is convened to determine the technology needs and estimated cost of performing that mission. Heuristics are one method of defining viable mission and systems architectures that can be assessed for technology readiness and cost. Developing a viable architecture depends to a large extent upon extending the existing body of knowledge, and applying it in new and novel ways. These heuristics have evolved over time to include methods for estimating technical complexity, technology development, cost modeling and mission risk in the unique context of deep space missions. This paper examines the processes involved in performing these advanced concepts studies, and analyzes the application of heuristics in the development of an advanced in-situ planetary mission. The Venus Surface Sample Return mission study provides a context for the examination of the heuristics applied in the development of the mission and systems architecture. This study is illustrative of the effort involved in the initial assessment of an advance mission concept, and the knowledge and tools that are applied.

Advanced Software Development Workstation Project

NASA Technical Reports Server (NTRS)

Lee, Daniel

1989-01-01

The Advanced Software Development Workstation Project, funded by Johnson Space Center, is investigating knowledge-based techniques for software reuse in NASA software development projects. Two prototypes have been demonstrated and a third is now in development. The approach is to build a foundation that provides passive reuse support, add a layer that uses domain-independent programming knowledge, add a layer that supports the acquisition of domain-specific programming knowledge to provide active support, and enhance maintainability and modifiability through an object-oriented approach. The development of new application software would use specification-by-reformulation, based on a cognitive theory of retrieval from very long-term memory in humans, and using an Ada code library and an object base. Current tasks include enhancements to the knowledge representation of Ada packages and abstract data types, extensions to support Ada package instantiation knowledge acquisition, integration with Ada compilers and relational databases, enhancements to the graphical user interface, and demonstration of the system with a NASA contractor-developed trajectory simulation package. Future work will focus on investigating issues involving scale-up and integration.

Phage display-derived human antibodies in clinical development and therapy

PubMed Central

Frenzel, André; Schirrmann, Thomas; Hust, Michael

2016-01-01

ABSTRACT Over the last 3 decades, monoclonal antibodies have become the most important class of therapeutic biologicals on the market. Development of therapeutic antibodies was accelerated by recombinant DNA technologies, which allowed the humanization of murine monoclonal antibodies to make them more similar to those of the human body and suitable for a broad range of chronic diseases like cancer and autoimmune diseases. In the early 1990s in vitro antibody selection technologies were developed that enabled the discovery of “fully” human antibodies with potentially superior clinical efficacy and lowest immunogenicity. Antibody phage display is the first and most widely used of the in vitro selection technologies. It has proven to be a robust, versatile platform technology for the discovery of human antibodies and a powerful engineering tool to improve antibody properties. As of the beginning of 2016, 6 human antibodies discovered or further developed by phage display were approved for therapy. In 2002, adalimumab (Humira®) became the first phage display-derived antibody granted a marketing approval. Humira® was also the first approved human antibody, and it is currently the best-selling antibody drug on the market. Numerous phage display-derived antibodies are currently under advanced clinical investigation, and, despite the availability of other technologies such as human antibody-producing transgenic mice, phage display has not lost its importance for the discovery and engineering of therapeutic antibodies. Here, we provide a comprehensive overview about phage display-derived antibodies that are approved for therapy or in clinical development. A selection of these antibodies is described in more detail to demonstrate different aspects of the phage display technology and its development over the last 25 years. PMID:27416017

The role and functions of Clinical Nurse Consultants, an Australian advanced practice role: a descriptive exploratory cohort study.

PubMed

Baldwin, Richard; Duffield, Christine Margaret; Fry, Margaret; Roche, Michael; Stasa, Helen; Solman, Annette

2013-03-01

The NSW Health Policy Directive (NSW Department of Health, 2000) lists clinical service and consultancy; clinical leadership; research; education; clinical services planning and management as the five domains of practice for nurses appointed as Clinical Nurse Consultants (CNCs), an Australian advanced practice nurse (APN) role. However, there is no clear definition of what is meant by advanced practice in the Australian nursing context. Nowhere is this more evident than in differentiating between the roles of Clinical Nurse Consultants (CNCs) and Nurse Practitioners (NP) in NSW. To date, limited empirical research has been done to characterise or delineate CNC role activity and responsibility. To investigate (i) the nature of CNC roles, activities and responsibilities, (ii) differentiate between CNCs by their work patterns and activities, and (iii) empirically conceptualize and differentiate ways CNCs practice in terms of an APN typology. The study sample was 56 CNCs at one tertiary level public hospital in Australia. A descriptive exploratory cohort study was conducted to explore CNC role characteristics and patterns of activity. Data were triangulated using an online survey, a follow-up survey, and semi-structured interviews. The data were analysed using descriptive statistics to examine differences between CNC work patterns and role activities. The survey data and the individual reports were thematically analysed to investigate for difference across the population of CNCs. Interpretation of survey and interview data led to an analyst-developed CNC typology of four CNC categories based on the work patterns and activities of Sole Practitioner, Clinic Coordinator, Clinical Team Coordinator and Clinical Leader. The typology was based on the themes interprofessional, role focus, clinical focus and setting as these themes distinguished and differentiated CNC roles. The study provides evidence of great diversity and prioritization within CNC roles. The CNC typology

Architectural development of an advanced EVA Electronic System

NASA Technical Reports Server (NTRS)

Lavelle, Joseph

1992-01-01

An advanced electronic system for future EVA missions (including zero gravity, the lunar surface, and the surface of Mars) is under research and development within the Advanced Life Support Division at NASA Ames Research Center. As a first step in the development, an optimum system architecture has been derived from an analysis of the projected requirements for these missions. The open, modular architecture centers around a distributed multiprocessing concept where the major subsystems independently process their own I/O functions and communicate over a common bus. Supervision and coordination of the subsystems is handled by an embedded real-time operating system kernel employing multitasking software techniques. A discussion of how the architecture most efficiently meets the electronic system functional requirements, maximizes flexibility for future development and mission applications, and enhances the reliability and serviceability of the system in these remote, hostile environments is included.

Advanced telepresence surgery system development.

PubMed

Jensen, J F; Hill, J W

1996-01-01

SRI International is currently developing a prototype remote telepresence surgery system, for the Advanced Research Projects Agency (ARPA), that will bring life-saving surgical care to wounded soldiers in the zone of combat. Remote surgery also has potentially important applications in civilian medicine. In addition, telepresence will find wide medical use in local surgery, in endoscopic, laparoscopic, and microsurgery applications. Key elements of the telepresence technology now being developed for ARPA, including the telepresence surgeon's workstation (TSW) and associated servo control systems, will have direct application to these areas of minimally invasive surgery. The TSW technology will also find use in surgical training, where it will provide an immersive visual and haptic interface for interaction with computer-based anatomical models. In this paper, we discuss our ongoing development of the MEDFAST telesurgery system, focusing on the TSW man-machine interface and its associated servo control electronics.

Characterization and development of materials for advanced textile composites

NASA Technical Reports Server (NTRS)

Hartness, J. Timothy; Greene, Timothy L.; Taske, Leo E.

1993-01-01

Work ongoing under the NASA Langley - Advanced Composite Technology (ACT) program is discussed. The primary emphasis of the work centers around the development and characterization of graphite fiber that has been impregnated with an epoxy powder. Four epoxies have been characterized in towpreg form as to their weaveability and braidability. Initial mechanical properties have been generated on each resin system. These include unidirectional as well as 8-harness satin cloth. Initial 2D and 3D weaving and braiding trials will be reported on as well as initial efforts to develop towpreg suitable for advanced tow placement.

In utero stem cell transplantation and gene therapy: rationale, history, and recent advances toward clinical application

PubMed Central

Almeida-Porada, Graça; Atala, Anthony; Porada, Christopher D

2016-01-01

Recent advances in high-throughput molecular testing have made it possible to diagnose most genetic disorders relatively early in gestation with minimal risk to the fetus. These advances should soon allow widespread prenatal screening for the majority of human genetic diseases, opening the door to the possibility of treatment/correction prior to birth. In addition to the obvious psychological and financial benefits of curing a disease in utero, and thereby enabling the birth of a healthy infant, there are multiple biological advantages unique to fetal development, which provide compelling rationale for performing potentially curative treatments, such as stem cell transplantation or gene therapy, prior to birth. Herein, we briefly review the fields of in utero transplantation (IUTx) and in utero gene therapy and discuss the biological hurdles that have thus far restricted success of IUTx to patients with immunodeficiencies. We then highlight several recent experimental breakthroughs in immunology, hematopoietic/marrow ontogeny, and in utero cell delivery, which have collectively provided means of overcoming these barriers, thus setting the stage for clinical application of these highly promising therapies in the near future. PMID:27069953

Development of clinical sites.

PubMed

O'Brien, Mary

2015-02-01

Clinical experiences are vital to all types of healthcare educational programs. Supervised clinical experiences provide the opportunity for the learner to apply didactic knowledge and theory to real world situations and hone skills necessary for entry into practice. Nurse anesthesia programs utilize a wide variety of clinical sites to expose student registered nurse anesthetists to experiences that will prepare them clinically, academically and professionally to enter practice as a Certified Registered Nurse Anesthetist. This article describes the process of developing a clinical site. A thorough evaluation will determine the types of experiences meant to be offered at the site, the resources available to house and educate the students, and how to evaluate the effectiveness of the clinical site. Open communication between the clinical coordinator and the program director or designee is essential to ensure success of the clinical site. The Council on Accreditation of Nurse Anesthesia Educational Programs has resources available to guide those interested in becoming a clinical site, as well as for program administrators who seek to add new experiences to their programs.

Advance Care Planning: Understanding Clinical Routines and Experiences of Interprofessional Team Members in Diverse Health Care Settings.

PubMed

Arnett, Kelly; Sudore, Rebecca L; Nowels, David; Feng, Cindy X; Levy, Cari R; Lum, Hillary D

2017-12-01

Interprofessional health care team members consider advance care planning (ACP) to be important, yet gaps remain in systematic clinical routines to support ACP. A clearer understanding of the interprofessional team members' perspectives on ACP clinical routines in diverse settings is needed. One hundred eighteen health care team members from community-based clinics, long-term care facilities, academic clinics, federally qualified health centers, and hospitals participated in a 35-question, cross-sectional online survey to assess clinical routines, workflow processes, and policies relating to ACP. Respondents were 53% physicians, 18% advanced practice nurses, 11% nurses, and 18% other interprofessional team members including administrators, chaplains, social workers, and others. Regarding clinical routines, respondents reported that several interprofessional team members play a role in facilitating ACP (ie, physician, social worker, nurse, others). Most (62%) settings did not have, or did not know of, policies related to ACP documentation. Only 14% of settings had a patient education program. Two-thirds of the respondents said that addressing ACP is a high priority and 85% felt that nonphysicians could have ACP conversations with appropriate training. The clinical resources needed to improve clinical routines included training for providers and staff, dedicated staff to facilitate ACP, and availability of patient/family educational materials. Although interprofessional health care team members consider ACP a priority and several team members may be involved, clinical settings lack systematic clinical routines to support ACP. Patient educational materials, interprofessional team training, and policies to support ACP clinical workflows that do not rely solely on physicians could improve ACP across diverse clinical settings.

Developments at the Advanced Design Technologies Testbed

NASA Technical Reports Server (NTRS)

VanDalsem, William R.; Livingston, Mary E.; Melton, John E.; Torres, Francisco J.; Stremel, Paul M.

2003-01-01

A report presents background and historical information, as of August 1998, on the Advanced Design Technologies Testbed (ADTT) at Ames Research Center. The ADTT is characterized as an activity initiated to facilitate improvements in aerospace design processes; provide a proving ground for product-development methods and computational software and hardware; develop bridging methods, software, and hardware that can facilitate integrated solutions to design problems; and disseminate lessons learned to the aerospace and information technology communities.

Combination therapy for advanced or metastatic non-small cell lung cancer will be tested in new clinical trial | Center for Cancer Research

Cancer.gov

Non-small cell lung cancer (NSCLC) develops when abnormal lung cells begin to grow out of control. These cells can form into a tumor and spread to other areas of the body. David Schrump, M.D., of the Thoracic and Gastrointestinal Oncology Branch is leading a clinical trial of a new combination treatment for patients with advanced or metastatic NSCLC that cannot be treated

Technological advances in radiotherapy for cervical cancer.

PubMed

Walsh, Lorraine; Morgia, Marita; Fyles, Anthony; Milosevic, Michael

2011-09-01

To discuss the important technological advances that have taken place in the planning and delivery of both external beam radiotherapy and brachytherapy for patients with locally advanced cervical cancer, and the implications for improved clinical outcomes. Technological advances in external beam radiation treatment and brachytherapy for patients with cervical cancer allow more precise targeting of tumour and relative sparing of surrounding normal organs and tissues. Early evidence is emerging to indicate that these advances will translate into improvements in tumour control and reduced side effects. However, there are patient, tumour and treatment-related factors that can detract from these benefits. Foremost among these is complex, unpredictable and sometimes dramatic internal tumour and normal organ motion during treatment. The focus of current research and clinical development is on tracking internal anatomic change in individual patients and adapting treatment plans as required to assure that optimal tumour coverage and normal tissue sparing is maintained at all times. The success of this approach will depend on clear definitions of target volumes, high resolution daily soft tissue imaging, and new software tools for rapid contouring, treatment planning and quality assurance. Radiation treatment of locally advanced cervical cancer is evolving rapidly, driven by advances in technology, towards more individualized patient care that has the potential to substantially improve clinical outcomes.

[The historical background and present development of evidence-based healthcare and clinical nursing].

PubMed

Tsai, Jung-Mei

2014-12-01

Evidence-based healthcare (EBHC) emphasizes the integration of the best research evidence with patient values, specialist suggestions, and clinical circumstances during the process of clinical decision-making. EBHC is a recognized core competency in modern healthcare. Nursing is a professional discipline of empirical science that thrives in an environment marked by advances in knowledge and technology in medicine as well as in nursing. Clinical nurses must elevate their skills and professional qualifications, provide efficient and quality health services, and promote their proficiency in EBHC. The Institute of Medicine in the United States indicates that evidence-based research results often fail to disseminate efficiently to clinical decision makers. This problem highlights the importance of better promoting the evidence-based healthcare fundamentals and competencies to frontline clinical nurses. This article describes the historical background and present development of evidence-based healthcare from the perspective of modern clinical nursing in light of the importance of evidence-based healthcare in clinical nursing; describes the factors associated with evidence-based healthcare promotion; and suggests strategies and policies that may improve the promotion and application of EBHC in clinical settings. The authors hope that this paper provides a reference for efforts to improve clinical nursing in the realms of EBHC training, promotion, and application.

Development and promotion in translational medicine: perspectives from 2012 sino-american symposium on clinical and translational medicine

PubMed Central

2012-01-01

Background Clinical translational medicine (CTM) is an emerging area comprising multidisciplinary research from basic science to medical applications and entails a close collaboration among hospital, academia and industry. Findings This Session focused discussing on new models for project development and promotion in translational medicine. The conference stimulated the scientific and commercial communication of project development between academies and companies, shared the advanced knowledge and expertise of clinical applications, and created the environment for collaborations. Conclusions Although strategic collaborations between corporate and academic institutions have resulted in a state of resurgence in the market, new cooperation models still need time to tell whether they will improve the translational medicine process. PMID:23369198

Drugs in development for toxoplasmosis: advances, challenges, and current status.

PubMed

Alday, P Holland; Doggett, Joseph Stone

2017-01-01

Toxoplasma gondii causes fatal and debilitating brain and eye diseases. Medicines that are currently used to treat toxoplasmosis commonly have toxic side effects and require prolonged courses that range from weeks to more than a year. The need for long treatment durations and the risk of relapsing disease are in part due to the lack of efficacy against T. gondii tissue cysts. The challenges for developing a more effective treatment for toxoplasmosis include decreasing toxicity, achieving therapeutic concentrations in the brain and eye, shortening duration, eliminating tissue cysts from the host, safety in pregnancy, and creating a formulation that is inexpensive and practical for use in resource-poor areas of the world. Over the last decade, significant progress has been made in identifying and developing new compounds for the treatment of toxoplasmosis. Unlike clinically used medicines that were repurposed for toxoplasmosis, these compounds have been optimized for efficacy against toxoplasmosis during preclinical development. Medicines with enhanced efficacy as well as features that address the unique aspects of toxoplasmosis have the potential to greatly improve toxoplasmosis therapy. This review discusses the facets of toxoplasmosis that are pertinent to drug design and the advances, challenges, and current status of preclinical drug research for toxoplasmosis.

Drugs in development for toxoplasmosis: advances, challenges, and current status

PubMed Central

Alday, P Holland; Doggett, Joseph Stone

2017-01-01

Toxoplasma gondii causes fatal and debilitating brain and eye diseases. Medicines that are currently used to treat toxoplasmosis commonly have toxic side effects and require prolonged courses that range from weeks to more than a year. The need for long treatment durations and the risk of relapsing disease are in part due to the lack of efficacy against T. gondii tissue cysts. The challenges for developing a more effective treatment for toxoplasmosis include decreasing toxicity, achieving therapeutic concentrations in the brain and eye, shortening duration, eliminating tissue cysts from the host, safety in pregnancy, and creating a formulation that is inexpensive and practical for use in resource-poor areas of the world. Over the last decade, significant progress has been made in identifying and developing new compounds for the treatment of toxoplasmosis. Unlike clinically used medicines that were repurposed for toxoplasmosis, these compounds have been optimized for efficacy against toxoplasmosis during preclinical development. Medicines with enhanced efficacy as well as features that address the unique aspects of toxoplasmosis have the potential to greatly improve toxoplasmosis therapy. This review discusses the facets of toxoplasmosis that are pertinent to drug design and the advances, challenges, and current status of preclinical drug research for toxoplasmosis. PMID:28182168

Advanced life support technology development for the Space Exploration Initiative

NASA Technical Reports Server (NTRS)

Evanich, Peggy L.; Voecks, Gerald E.; Seshan, P. K.

1990-01-01

An overview is presented of NASA's advanced life support technology development strategy for the Space Exploration Initiative. Three basic life support technology areas are discussed in detail: air revitalization, water reclamation, and solid waste management. It is projected that regenerative life support systems will become increasingly more complex as system closure is maximized. Advanced life support technology development will utilize three complementary elements, including the Research and Technology Program, the Regenerative Life Support Program, and the Technology Testbed Validations.

Development of a pharmacy resident rotation to expand decentralized clinical pharmacy services.

PubMed

Hill, John D; Williams, Jonathan P; Barnes, Julie F; Greenlee, Katie M; Cardiology, Bcps-Aq; Leonard, Mandy C

2017-07-15

The development of a pharmacy resident rotation to expand decentralized clinical pharmacy services is described. In an effort to align with the initiatives proposed within the ASHP Practice Advancement Initiative, the department of pharmacy at Cleveland Clinic, a 1,400-bed academic, tertiary acute care medical center in Cleveland, Ohio, established a goal to provide decentralized clinical pharmacy services for 100% of patient care units within the hospital. Patient care units that previously had no decentralized pharmacy services were evaluated to identify opportunities for expansion. Metrics analyzed included number of medication orders verified per hour, number of pharmacy dosing consultations, and number of patient discharge counseling sessions. A pilot study was conducted to assess the feasibility of this service and potential resident learning opportunities. A learning experience description was drafted, and feedback was solicited regarding the development of educational components utilized throughout the rotation. Pharmacists who were providing services to similar patient populations were identified to serve as preceptors. Staff pharmacists were deployed to previously uncovered patient care units, with pharmacy residents providing decentralized services on previously covered areas. A rotating preceptor schedule was developed based on geographic proximity and clinical expertise. An initial postimplementation assessment of this resident-driven service revealed that pharmacy residents provided a comparable level of pharmacy services to that of staff pharmacists. Feedback collected from nurses, physicians, and pharmacy staff also supported residents' ability to operate sufficiently in this role to optimize patient care. A learning experience developed for pharmacy residents in a large medical center enabled the expansion of decentralized clinical services without requiring additional pharmacist full-time equivalents. Copyright © 2017 by the American Society of

Renewable Energy Laboratory Development for Biofuels Advanced Combustion Studies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Soloiu, Valentin A.

2012-03-31

The research advanced fundamental science and applied engineering for increasing the efficiency of internal combustion engines and meeting emissions regulations with biofuels. The project developed a laboratory with new experiments and allowed investigation of new fuels and their combustion and emissions. This project supports a sustainable domestic biofuels and automotive industry creating economic opportunities across the nation, reducing the dependence on foreign oil, and enhancing U.S. energy security. The one year period of research developed fundamental knowledge and applied technology in advanced combustion, emissions and biofuels formulation to increase vehicle's efficiency. Biofuels combustion was investigated in a Compression Ignition Directmore » Injection (DI) to develop idling strategies with biofuels and an Indirect Diesel Injection (IDI) intended for auxiliary power unit.« less

Optimising translational oncology in clinical practice: strategies to accelerate progress in drug development.

PubMed

Stahel, R; Bogaerts, J; Ciardiello, F; de Ruysscher, D; Dubsky, P; Ducreux, M; Finn, S; Laurent-Puig, P; Peters, S; Piccart, M; Smit, E; Sotiriou, C; Tejpar, S; Van Cutsem, E; Tabernero, J

2015-02-01

Despite intense efforts, the socioeconomic burden of cancer remains unacceptably high and treatment advances for many common cancers have been limited, suggesting a need for a new approach to drug development. One issue central to this lack of progress is the heterogeneity and genetic complexity of many tumours. This results in considerable variability in therapeutic response and requires knowledge of the molecular profile of the tumour to guide appropriate treatment selection for individual patients. While recent advances in the molecular characterisation of different cancer types have the potential to transform cancer treatment through precision medicine, such an approach presents a major economic challenge for drug development, since novel targeted agents may only be suitable for a small cohort of patients. Identifying the patients who would benefit from individual therapies and recruiting sufficient numbers of patients with particular cancer subtypes into clinical trials is challenging, and will require collaborative efforts from research groups and industry in order to accelerate progress. A number of molecular screening platforms have already been initiated across Europe, and it is hoped that these networks, along with future collaborations, will benefit not only patients but also society through cost reductions as a result of more efficient use of resources. This review discusses how current developments in translational oncology may be applied in clinical practice in the future, assesses current programmes for the molecular characterisation of cancer and describes possible collaborative approaches designed to maximise the benefits of translational science for patients with cancer. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Advances in the understanding of the clinically relevant genetic pathways and molecular aspects of canine mammary tumours. Part 2: invasion, angiogenesis, metastasis and therapy.

PubMed

Santos, A A; Matos, A J F

2015-08-01

Significant advances have been made recently in the understanding of the molecular events and critical pathways associated with and driving cancer of the mammary gland in humans and dogs. The study of canine mammary tumour biology, particularly the interactions of neoplastic cells with stromal and immune cells, is crucial for the development of novel effective therapeutic agents and strategies. This second part of a two-part review discusses some of the latest advances in the understanding of the clinically relevant genetic and molecular pathways involved in metastasis and in the interactions between tumour and stromal cells, including inflammatory and immune cells, cancer-associated fibroblasts, and endothelial cells. Recent experimental data on the role of matrix-degrading proteases and angiogenic factors are also discussed. Finally, the clinical utility of different non-surgical therapeutic modalities is reviewed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Major clinical research advances in gynecologic cancer in 2017.

PubMed

Suh, Dong Hoon; Kim, Miseon; Lee, Kyung Hun; Eom, Keun Yong; Kjeldsen, Maj Kamille; Mirza, Mansoor Raza; Kim, Jae Weon

2018-03-01

In 2017, 10 topics were selected as major clinical research advances in gynecologic oncology. For cervical cancer, efficacy and safety analysis results of a 9-valent human papillomavirus (HPV) vaccine and long-term impact of reduced dose of quadrivalent vaccine were updated. Brief introduction of KEYNOTE trials of pembrolizumab, a monoclonal antibody that blocks the interaction between programmed death (PD)-1 and its ligands, PD-L1 and PD-L2, followed. Tailored surveillance programs for gynecologic cancer related with Lynch syndrome and update on sentinel lymph node mapping were reviewed for uterine corpus cancer. For ovarian cancer, 5 topics were selected including poly(ADP-ribose) polymerases inhibitors and immunotherapy. The other potential practice changers covered in this review were lymphadenectomy in advanced disease, secondary cytoreductive surgery in recurrent disease, weekly dose-dense regimen for first-line chemotherapy, incorporation of bevacizumab maintenance in platinum-sensitive recurrent disease, and effect of platinum-free interval prolongation. Conflicting opinions of academic societies on periodic pelvic examination were introduced in conjunction with relevant literature review. For the field of radiation oncology, results of 2 big trials, The Postoperative Radiation Therapy in Endometrial Carcinoma-3 and Gynecologic Oncology Group-258, for endometrial cancer and recent advance in high-dose-rate brachytherapy for cervical cancer were reported. Topics for breast cancer covered adjuvant capecitabine after preoperative chemotherapy, adjuvant pertuzumab and trastuzumab in early human epidermal growth factor receptor 2-positive disease, olaparib for metastatic cancer in patients with a germline BRCA mutation, 20-year risks of recurrence after stopping endocrine therapy at 5 years, and contemporary hormonal contraception and the risk of breast cancer. Copyright © 2018. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.

[Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases].

PubMed

Uchida, Eriko; Igarashi, Yuka; Sato, Yoji

2014-01-01

Gene therapy products are expected as innovative medicinal products for intractable diseases such as life-threatening genetic diseases and cancer. Recently, clinical developments by pharmaceutical companies are accelerated in Europe and the United States, and the first gene therapy product in advanced countries was approved for marketing authorization by the European Commission in 2012. On the other hand, more than 40 clinical studies for gene therapy have been completed or ongoing in Japan, most of them are conducted as clinical researches by academic institutes, and few clinical trials have been conducted for approval of gene therapy products. In order to promote the development of gene therapy products, revision of the current guideline and/or preparation of concept paper to address the evaluation of the quality and safety of gene therapy products are necessary and desired to clearly show what data should be submitted before First-in-Human clinical trials of novel gene therapy products. We started collaborative study with academia and regulatory agency to promote regulatory science toward clinical development of gene therapy products for genetic diseases based on lentivirus and adeno-associated virus vectors; National Center for Child Health and Development (NCCHD), Nippon Medical School and PMDA have been joined in the task force. At first, we are preparing pre-draft of the revision of the current gene therapy guidelines in this project.

How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials.

PubMed

Bonnetain, F; Borg, C; Adams, R R; Ajani, J A; Benson, A; Bleiberg, H; Chibaudel, B; Diaz-Rubio, E; Douillard, J Y; Fuchs, C S; Giantonio, B J; Goldberg, R; Heinemann, V; Koopman, M; Labianca, R; Larsen, A K; Maughan, T; Mitchell, E; Peeters, M; Punt, C J A; Schmoll, H J; Tournigand, C; de Gramont, A

2017-09-01

Traditionally, the efficacy of cancer treatment in patients with advance or metastatic disease in clinical studies has been studied using overall survival and more recently tumor-based end points such as progression-free survival, measurements of response to treatment. However, these seem not to be the relevant clinical end points in current situation if such end points were no validated as surrogate of overall survival to demonstrate the clinical efficacy. Appropriate, meaningful, primary patient-oriented and patient-reported end points that adequately measure the effects of new therapeutic interventions are then crucial for the advancement of clinical research in metastatic colorectal cancer to complement the results of tumor-based end points. Health-related quality of life (HRQoL) is effectively an evaluation of quality of life and its relationship with health over time. HRQoL includes the patient report at least of the way a disease or its treatment affects its physical, emotional and social well-being. Over the past few years, several phase III trials in a variety of solid cancers have assessed the incremental value of HRQoL in addition to the traditional end points of tumor response and survival results. HRQoL could provide not only complementary clinical data to the primary outcomes, but also more precise predictive and prognostic value. This end point is useful for both clinicians and patients in order to achieve the dogma of precision medicine. The present article examines the use of HRQoL in phase III metastatic colorectal cancer clinical trials, outlines the importance of HRQoL assessment methods, analysis, and results presentation. Moreover, it discusses the relevance of including HRQoL as a primary/co-primary end point to support the progression-free survival results and to assess efficacy of treatment in the advanced disease setting. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All

Primary ciliary dyskinesia. Recent advances in diagnostics, genetics, and characterization of clinical disease.

PubMed

Knowles, Michael R; Daniels, Leigh Anne; Davis, Stephanie D; Zariwala, Maimoona A; Leigh, Margaret W

2013-10-15

Primary ciliary dyskinesia (PCD) is a genetically heterogeneous recessive disorder of motile cilia that leads to oto-sino-pulmonary diseases and organ laterality defects in approximately 50% of cases. The estimated incidence of PCD is approximately 1 per 15,000 births, but the prevalence of PCD is difficult to determine, primarily because of limitations in diagnostic methods that focus on testing ciliary ultrastructure and function. Diagnostic capabilities have recently benefitted from (1) documentation of low nasal nitric oxide production in PCD and (2) discovery of biallelic mutations in multiple PCD-causing genes. The use of these complementary diagnostic approaches shows that at least 30% of patients with PCD have normal ciliary ultrastructure. More accurate identification of patients with PCD has also allowed definition of a strong clinical phenotype, which includes neonatal respiratory distress in >80% of cases, daily nasal congestion and wet cough starting soon after birth, and early development of recurrent/chronic middle-ear and sinus disease. Recent studies, using advanced imaging and pulmonary physiologic assessments, clearly demonstrate early onset of lung disease in PCD, with abnormal air flow mechanics by age 6-8 years that is similar to cystic fibrosis, and age-dependent onset of bronchiectasis. The treatment of PCD is not standardized, and there are no validated PCD-specific therapies. Most patients with PCD receive suboptimal management, which should include airway clearance, regular surveillance of pulmonary function and respiratory microbiology, and use of antibiotics targeted to pathogens. The PCD Foundation is developing a network of clinical centers, which should improve diagnosis and management of PCD.

Primary Ciliary Dyskinesia. Recent Advances in Diagnostics, Genetics, and Characterization of Clinical Disease

PubMed Central

Daniels, Leigh Anne; Davis, Stephanie D.; Zariwala, Maimoona A.; Leigh, Margaret W.

2013-01-01

Primary ciliary dyskinesia (PCD) is a genetically heterogeneous recessive disorder of motile cilia that leads to oto-sino-pulmonary diseases and organ laterality defects in approximately 50% of cases. The estimated incidence of PCD is approximately 1 per 15,000 births, but the prevalence of PCD is difficult to determine, primarily because of limitations in diagnostic methods that focus on testing ciliary ultrastructure and function. Diagnostic capabilities have recently benefitted from (1) documentation of low nasal nitric oxide production in PCD and (2) discovery of biallelic mutations in multiple PCD-causing genes. The use of these complementary diagnostic approaches shows that at least 30% of patients with PCD have normal ciliary ultrastructure. More accurate identification of patients with PCD has also allowed definition of a strong clinical phenotype, which includes neonatal respiratory distress in >80% of cases, daily nasal congestion and wet cough starting soon after birth, and early development of recurrent/chronic middle-ear and sinus disease. Recent studies, using advanced imaging and pulmonary physiologic assessments, clearly demonstrate early onset of lung disease in PCD, with abnormal air flow mechanics by age 6–8 years that is similar to cystic fibrosis, and age-dependent onset of bronchiectasis. The treatment of PCD is not standardized, and there are no validated PCD-specific therapies. Most patients with PCD receive suboptimal management, which should include airway clearance, regular surveillance of pulmonary function and respiratory microbiology, and use of antibiotics targeted to pathogens. The PCD Foundation is developing a network of clinical centers, which should improve diagnosis and management of PCD. PMID:23796196

Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.

PubMed

Vivot, A; Jacot, J; Zeitoun, J-D; Ravaud, P; Crequit, P; Porcher, R

2017-05-01

Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical benefit of new drugs for treating advanced solid tumors at the time of their approval by the US Food and Drug Administration (FDA) and to search for a relation between price and clinical benefit of drugs. We included all new molecular entities and new biologics for treating advanced solid cancer that were approved by the FDA between 2000 and 2015. The clinical benefit of drugs was graded based on FDA medical review of pivotal clinical trials using the 2016-updated of the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Characteristics of drugs and approvals were obtained from publicly available FDA documents and price was evaluated according to US Medicare, US Veterans Health Administration and United Kingdom market systems. The FDA approved 51 new drugs for advanced solid cancer from 2000 to 2015; we could evaluate the value of 37 drugs (73%). By the ESMO-MCBS, five drugs (14%) were grade one (the lowest), nine (24%) grade two, 10 (27%) grade three, 11 (30%) grade four and two (5%) grade five (the highest). Thus, 13 drugs (35%) showed a meaningful clinical benefit (scale levels 4 and 5). By the ASCO-VF which had a range of 3.4-67, the median drug value was 37 (interquartile range 20-52). We found no relationship between clinical benefit and drug price (P = 0.9). No characteristic of drugs and of approval was significantly associated with clinical benefit. Many recently FDA-approved new cancer drugs did not have high clinical benefit as measured by current scales. We found no relation between the price of drugs and benefit to society and patients. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

The Role of Research in Advanced Dental Education.

ERIC Educational Resources Information Center

Profitt, William R.; Vig, Peter S.

1980-01-01

Even though research is an integral part of quality advanced dental programs, many dental departments with postdoctoral programs lack faculty and other resources for research productivity. Programs to produce clinical faculty with research training are called for through the development of clinical research centers. (JSR)

Evaluating the impact of a pre-rotation workshop on student preparation for clinical advanced pharmacy practice experiences.

PubMed

Medina, Melissa S; Stark, Jennifer E; Vesta, Kimi S; Lockhart, Staci M

2008-10-01

This pilot study was designed to evaluate the impact of a pre-rotation workshop (PRW) on pharmacy students' clinical skills and preparation for clinical Advanced Pharmacy Practice Experiences (APPE) involving direct patient care. Randomized controlled trial of an educational intervention with Institutional Review Board approval. PRW activities designed to simulate rotation activities around five competencies, patient charts, medication histories, SOAP notes, patient presentations, and professionalism. Endpoints were evaluated using clinical rotation preceptors' evaluation of performance and students' performance on objective structured clinical exams (OSCE). Eight fourth-year students and eight GPA matched controls (20% of the total class) were selected to voluntarily participate. The PRW demonstrated a positive impact on students' clinical skills and preparation for rotations by improving OSCE performance. However, no significant differences were found between groups when comparing preceptor evaluations of skills on rotations. These results are limited by the small sample size, potential OSCE "test-wiseness" effects, lack of OSCE evaluator blinding to study groups, potential case specificity effects due to the limited number of cases used on the OSCE and possible lack of sensitivity of the rotation evaluation tool to capture true differences among the experimental and control group participants. The PRW was successful at advancing students' clinical skills and preparation for rotations and may be considered as a tool to help bridge didactic to clinical experiences in the Pharm.D. curriculum.

[Development of an ophthalmological clinical information system for inpatient eye clinics].

PubMed

Kortüm, K U; Müller, M; Babenko, A; Kampik, A; Kreutzer, T C

2015-12-01

In times of increased digitalization in healthcare, departments of ophthalmology are faced with the challenge of introducing electronic clinical health records (EHR); however, specialized software for ophthalmology is not available with most major EHR sytems. The aim of this project was to create specific ophthalmological user interfaces for large inpatient eye care providers within a hospitalwide EHR. Additionally the integration of ophthalmic imaging systems, scheduling and surgical documentation should be achieved. The existing EHR i.s.h.med (Siemens, Germany) was modified using advanced business application programming (ABAP) language to create specific ophthalmological user interfaces for reproduction and moreover optimization of the clinical workflow. A user interface for documentation of ambulatory patients with eight tabs was designed. From June 2013 to October 2014 a total of 61,551 patient contact details were documented. For surgical documentation a separate user interface was set up. Digital clinical orders for documentation of registration and scheduling of operations user interfaces were also set up. A direct integration of ophthalmic imaging modalities could be established. An ophthalmologist-orientated EHR for outpatient and surgical documentation for inpatient clinics was created and successfully implemented. By incorporation of imaging procedures the foundation of future smart/big data analyses was created.

Clinical response to apatinib monotherapy in advanced non-small cell lung cancer.

PubMed

Xu, Jianping; Liu, Xiaoyan; Yang, Sheng; Zhang, Xiangru; Shi, Yuankai

2018-06-01

Apatinib, an oral tyrosine kinase inhibitor mainly targeting VEGFR-2, exerts both antiangiogenesis and antiproliferation effects. Apatinib shows clinical benefit in advanced non-small cell lung cancer (NSCLC) at an initial dose of 750 mg qd. We further assessed the efficacy and safety of apatinib at a more frequently used dose of 500 mg qd. The preliminary clinical outcome of apatinib in patients with brain metastases was also reported. We retrospectively reviewed the clinical data of 25 patients who received apatinib between August 2015 and May 2016. Progression-free survival (PFS) was calculated by using the Kaplan-Meier method. The objective response rate and disease control rate were 8.0% and 68.0%, respectively. The median PFS was 5.17 (95% confidence interval [CI]: 0.76-9.57) months. In the second-line setting (n = 13), the median PFS was 7.37 (95% CI: 0.01-14.72) months, whereas the median PFS for the 12 patients treated with apatinib as third line or beyond therapy was 5.17 (95% CI: 1.78-8.55) months. Of the seven patients with brain metastases, four patients had stable disease. All patients were well tolerant to apatinib without any grade 3 or 4 adverse events. The most common grade 1 or 2 adverse events included hypertension (72.0%), hand-foot-skin reaction (24.0%), fatigue (24.0%) and abnormal liver function (20.0%). Apatinib is effective and well tolerated in patients with advanced NSCLC, even at a dosage of 500 mg qd, and might offer a new option for the treatment of such patients with brain metastases. © 2017 John Wiley & Sons Australia, Ltd.

Building foundations for the future: the NHS Scotland advanced practice succession planning development pathway.

PubMed

Currie, Kay; Grundy, Maggie

2011-10-01

To highlight implications for managers from the implementation of a national advanced practice succession planning development pathway within Scotland. Internationally, advanced practice posts have often developed in an ad-hoc manner, with little organizational attention to succession planning. Evaluation of a pilot national succession planning development pathway identified mechanisms which facilitate or hamper effective planning for advanced practice roles. A responsive evaluation design incorporating semi-structured questionnaires to pathway participants (n = 15) and semi-structured telephone interviews with case-site pathway participants (n = 7) and their line managers. Managers believed the development pathway was worthwhile; however, there was limited strategic planning to match individuals' development to service need. Practitioners generally perceived managers as interested in their development, although levels of practical support varied. There is concern from both managers and practitioners regarding ongoing funding for advanced practice development. The present evaluation study reiterates the need for organizational commitment to succession planning including robust service needs analysis mechanisms and adequate funding for development processes. Nurse managers are viewed as the 'gatekeepers' to opportunities for developing advanced nurse practitioners; scare resources must be targeted effectively to support succession planning through the development of selected individuals for future advanced practice posts, justified by service need. © 2011 Blackwell Publishing Ltd.

Advanced practice nurses core competencies: a framework for developing and testing an advanced practice nurse discharge intervention.

PubMed

Cooke, Liz; Gemmill, Robin; Grant, Marcia

2008-01-01

The purpose of this paper was to describe evidenced-based interventions as implemented by advanced practice nurses (APNs) conducting intervention research with a vulnerable population of blood and marrow transplant patients. In addition, each of the 6 core competencies of the APN role identified by Hamric are outlined and applied using a patient case study. These competencies are the following: direct clinical practice, expert coaching and advice, consultation, research skills, clinical and professional leadership, collaboration, and ethical decision making. This article chronicles a typical patient's journey through a post-hospital discharge nursing research study involving APNs as "intervention nurses" and discusses the various aspects of the APN core competencies throughout the process.

Advances in TlBr detector development

NASA Astrophysics Data System (ADS)

Hitomi, Keitaro; Shoji, Tadayoshi; Ishii, Keizo

2013-09-01

Thallium bromide (TlBr) is a promising compound semiconductor for fabrication of gamma-ray detectors. The attractive physical properties of TlBr lie in its high photon stopping power, high resistivity and good charge transport properties. Gamma-ray detectors fabricated from TlBr crystals have exhibited excellent spectroscopic performance. In this paper, advances in TlBr radiation detector development are reviewed with emphasis on crystal growth, detector fabrication, physical properties and detector performance.

The CARE guidelines: consensus-based clinical case report guideline development.

PubMed

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2014-01-01

A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.

Combination therapy for advanced or metastatic non-small cell lung cancer will be tested in new clinical trial | Center for Cancer Research

Cancer.gov

Non-small cell lung cancer (NSCLC) develops when abnormal lung cells begin to grow out of control. These cells can form into a tumor and spread to other areas of the body. David Schrump, M.D., of the Thoracic and Gastrointestinal Oncology Branch is leading a clinical trial of a new combination treatment for patients with advanced or metastatic NSCLC that cannot be treated surgically. Read more... 

Technology development program for an advanced microsheet glass concentrator

NASA Technical Reports Server (NTRS)

Richter, Scott W.; Lacy, Dovie E.

1990-01-01

Solar Dynamic Space Power Systems are candidate electrical power generating systems for future NASA missions. One of the key components in a solar dynamic power system is the concentrator which collects the sun's energy and focuses it into a receiver. In 1985, the NASA Lewis Research Center initiated the Advanced Solar Dynamic Concentrator Program with funding from NASA's Office of Aeronautics and Space Technology (OAST). The objectives of the Advanced Concentrator Program is to develop the technology that will lead to lightweight, highly reflective, accurate, scaleable, and long lived (7 to 10 years) space solar dynamic concentrators. The Advanced Concentrator Program encompasses new and innovative concepts, fabrication techniques, materials selection, and simulated space environmental testing. The Advanced Microsheet Glass Concentrator Program, a reflector concept, that is currently being investigated both in-house and under contract is discussed.

Advanced Space Radiation Detector Technology Development

NASA Technical Reports Server (NTRS)

Wrbanek, John D.; Wrbanek, Susan Y.; Fralick, Gustave C.

2013-01-01

The advanced space radiation detector development team at the NASA Glenn Research Center (GRC) has the goal of developing unique, more compact radiation detectors that provide improved real-time data on space radiation. The team has performed studies of different detector designs using a variety of combinations of solid-state detectors, which allow higher sensitivity to radiation in a smaller package and operate at lower voltage than traditional detectors. Integration of multiple solid-state detectors will result in an improved detector system in comparison to existing state-of-the-art instruments for the detection and monitoring of the space radiation field for deep space and aerospace applications.

Advanced Space Radiation Detector Technology Development

NASA Technical Reports Server (NTRS)

Wrbanek, John D.; Wrbanek, Susan Y.; Fralick, Gustave C.

2013-01-01

The advanced space radiation detector development team at NASA Glenn Research Center (GRC) has the goal of developing unique, more compact radiation detectors that provide improved real-time data on space radiation. The team has performed studies of different detector designs using a variety of combinations of solid-state detectors, which allow higher sensitivity to radiation in a smaller package and operate at lower voltage than traditional detectors. Integration of multiple solid-state detectors will result in an improved detector system in comparison to existing state-of-the-art instruments for the detection and monitoring of the space radiation field for deep space and aerospace applications.

Advanced Space Radiation Detector Technology Development

NASA Technical Reports Server (NTRS)

Wrbanek, John D.; Wrbanek, Susan Y.; Fralick, Gustave C.

2013-01-01

The advanced space radiation detector development team at NASA Glenn Research Center (GRC) has the goal of developing unique, more compact radiation detectors that provide improved real-time data on space radiation. The team has performed studies of different detector designs using a variety of combinations of solid-state detectors, which allow higher sensitivity to radiation in a smaller package and operate at lower voltage than traditional detectors. Integration of multiple solid-state detectors will result in an improved detector system in comparison to existing state-of-the-art (SOA) instruments for the detection and monitoring of the space radiation field for deep space and aerospace applications.

Advanced Plasma Pyrolysis Assembly (PPA) Reactor and Process Development

NASA Technical Reports Server (NTRS)

Wheeler, Richard R., Jr.; Hadley, Neal M.; Dahl, Roger W.; Abney, Morgan B.; Greenwood, Zachary; Miller, Lee; Medlen, Amber

2012-01-01

Design and development of a second generation Plasma Pyrolysis Assembly (PPA) reactor is currently underway as part of NASA's Atmosphere Revitalization Resource Recovery effort. By recovering up to 75% of the hydrogen currently lost as methane in the Sabatier reactor effluent, the PPA helps to minimize life support resupply costs for extended duration missions. To date, second generation PPA development has demonstrated significant technology advancements over the first generation device by doubling the methane processing rate while, at the same time, more than halving the required power. One development area of particular interest to NASA system engineers is fouling of the PPA reactor with carbonaceous products. As a mitigation plan, NASA MSFC has explored the feasibility of using an oxidative plasma based upon metabolic CO2 to regenerate the reactor window and gas inlet ports. The results and implications of this testing are addressed along with the advanced PPA reactor development.

Advanced Mirror & Modelling Technology Development

NASA Technical Reports Server (NTRS)

Effinger, Michael; Stahl, H. Philip; Abplanalp, Laura; Maffett, Steven; Egerman, Robert; Eng, Ron; Arnold, William; Mosier, Gary; Blaurock, Carl

2014-01-01

The 2020 Decadal technology survey is starting in 2018. Technology on the shelf at that time will help guide selection to future low risk and low cost missions. The Advanced Mirror Technology Development (AMTD) team has identified development priorities based on science goals and engineering requirements for Ultraviolet Optical near-Infrared (UVOIR) missions in order to contribute to the selection process. One key development identified was lightweight mirror fabrication and testing. A monolithic, stacked, deep core mirror was fused and replicated twice to achieve the desired radius of curvature. It was subsequently successfully polished and tested. A recently awarded second phase to the AMTD project will develop larger mirrors to demonstrate the lateral scaling of the deep core mirror technology. Another key development was rapid modeling for the mirror. One model focused on generating optical and structural model results in minutes instead of months. Many variables could be accounted for regarding the core, face plate and back structure details. A portion of a spacecraft model was also developed. The spacecraft model incorporated direct integration to transform optical path difference to Point Spread Function (PSF) and between PSF to modulation transfer function. The second phase to the project will take the results of the rapid mirror modeler and integrate them into the rapid spacecraft modeler.

Describing the implementation of an innovative intervention and evaluating its effectiveness in increasing research capacity of advanced clinical nurses: using the consolidated framework for implementation research.

PubMed

McKee, Gabrielle; Codd, Margaret; Dempsey, Orla; Gallagher, Paul; Comiskey, Catherine

2017-01-01

Despite advanced nursing roles having a research competency, participation in research is low. There are many barriers to participation in research and few interventions have been developed to address these. This paper aims to describe the implementation of an intervention to increase research participation in advanced clinical nursing roles and evaluate its effectiveness. The implementation of the intervention was carried out within one hospital site. The evaluation utilised a mixed methods design and a implementation science framework. All staff in advanced nursing roles were invited to take part, all those who were interested and had a project in mind could volunteer to participate in the intervention. The intervention consisted of the development of small research groups working on projects developed by the nurse participant/s and supported by an academic and a research fellow. The main evaluation was through focus groups. Output was analysed using thematic analysis. In addition, a survey questionnaire was circulated to all participants to ascertain their self-reported research skills before and after the intervention. The results of the survey were analysed using descriptive statistics. Finally an inventory of research outputs was collated. In the first year, twelve new clinical nurse-led research projects were conducted and reported in six peer reviewed papers, two non-peer reviewed papers and 20 conference presentations. The main strengths of the intervention were its promptness to complete research, to publish and to showcase clinical innovations. Main barriers identified were time, appropriate support from academics and from peers. The majority of participants had increased experience at scientific writing and data analysis. This study shows that an intervention, with minor financial resources; a top down approach; support of a hands on research fellow; peer collaboration with academics; strong clinical ownership by the clinical nurse researcher

Regional characteristics relevant to advanced technology cogeneration development. [industrial energy

NASA Technical Reports Server (NTRS)

Manvi, R.

1981-01-01

To assist DOE in establishing research and development funding priorities in the area of advanced energy conversion technoloy, researchers at the Jet Propulsion Laboratory studied those specific factors within various regions of the country that may influence cogeneration with advanced energy conversion systems. Regional characteristics of advanced technology cogeneration possibilities are discussed, with primary emphasis given to coal derived fuels. Factors considered for the study were regional industry concentration, purchased fuel and electricity prices, environmental constraints, and other data of interest to industrial cogeneration.

Engaging Clinical Nurses in Quality Improvement Projects.

PubMed

Moore, Susan; Stichler, Jaynelle F

2015-10-01

Clinical nurses have the knowledge and expertise required to provide efficient and proficient patient care. Time and knowledge deficits can prevent nurses from developing and implementing quality improvement or evidence-based practice projects. This article reviews a process for professional development of clinical nurses that helped them to define, implement, and analyze quality improvement or evidence-based practice projects. The purpose of this project was to educate advanced clinical nurses to manage a change project from inception to completion, using the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) Change Acceleration Process as a framework. One-to-one mentoring and didactic in-services advanced the knowledge, appreciation, and practice of advanced practice clinicians who completed multiple change projects. The projects facilitated clinical practice changes, with improved patient outcomes; a unit cultural shift, with appreciation of quality improvement and evidence-based projects; and engagement with colleagues. Project outcomes were displayed in poster presentations at a hospital exposition for knowledge dissemination. Copyright 2015, SLACK Incorporated.

Development of tailorable advanced blanket insulation for advanced space transportation systems

NASA Technical Reports Server (NTRS)

Calamito, Dominic P.

1987-01-01

Two items of Tailorable Advanced Blanket Insulation (TABI) for Advanced Space Transportation Systems were produced. The first consisted of flat panels made from integrally woven, 3-D fluted core having parallel fabric faces and connecting ribs of Nicalon silicon carbide yarns. The triangular cross section of the flutes were filled with mandrels of processed Q-Fiber Felt. Forty panels were prepared with only minimal problems, mostly resulting from the unavailability of insulation with the proper density. Rigidizing the fluted fabric prior to inserting the insulation reduced the production time. The procedures for producing the fabric, insulation mandrels, and TABI panels are described. The second item was an effort to determine the feasibility of producing contoured TABI shapes from gores cut from flat, insulated fluted core panels. Two gores of integrally woven fluted core and single ply fabric (ICAS) were insulated and joined into a large spherical shape employing a tadpole insulator at the mating edges. The fluted core segment of each ICAS consisted of an Astroquartz face fabric and Nicalon face and rib fabrics, while the single ply fabric segment was Nicalon. Further development will be required. The success of fabricating this assembly indicates that this concept may be feasible for certain types of space insulation requirements. The procedures developed for weaving the ICAS, joining the gores, and coating certain areas of the fabrics are presented.

Status of NASA's Advanced Radioisotope Power Conversion Technology Research and Development

NASA Technical Reports Server (NTRS)

Wong, Wayne A.; Anderson, David J.; Tuttle, Karen L.; Tew, Roy C.

2006-01-01

NASA s Advanced Radioisotope Power Systems (RPS) development program is funding the advancement of next generation power conversion technologies that will enable future missions that have requirements that can not be met by either the ubiquitous photovoltaic systems or by current Radioisotope Power Systems (RPS). Requirements of advanced radioisotope power systems include high efficiency and high specific power (watts/kilogram) in order to meet mission requirements with less radioisotope fuel and lower mass. Other Advanced RPS development goals include long-life, reliability, and scalability so that these systems can meet requirements for a variety of future space applications including continual operation surface missions, outer-planetary missions, and solar probe. This paper provides an update on the Radioisotope Power Conversion Technology Project which awarded ten Phase I contracts for research and development of a variety of power conversion technologies consisting of Brayton, Stirling, thermoelectrics, and thermophotovoltaics. Three of the contracts continue during the current Phase II in the areas of thermoelectric and Stirling power conversion. The accomplishments to date of the contractors, project plans, and status will be summarized.

Intestinal microbiota, probiotics and mental health: from Metchnikoff to modern advances: part III - convergence toward clinical trials.

PubMed

Bested, Alison C; Logan, Alan C; Selhub, Eva M

2013-03-16

Rapid scientific and technological advances have allowed for a more detailed understanding of the relevance of intestinal microbiota, and the entire body-wide microbiome, to human health and well-being. Rodent studies have provided suggestive evidence that probiotics (e.g. lactobacillus and bifidobacteria) can influence behavior. More importantly, emerging clinical studies indicate that the administration of beneficial microbes, via supplementation and/or fecal microbial transplant (FMT), can influence end-points related to mood state (glycemic control, oxidative status, uremic toxins), brain function (functional magnetic resonance imaging fMRI), and mental outlook (depression, anxiety). However, despite the advances in the area of gastro-biological psychiatry, it becomes clear that there remains an urgent need to explore the value of beneficial microbes in controlled clinical investigations. With the history explored in this series, it is fair to ask if we are now on the cusp of major clinical breakthroughs, or are we merely in the quicksand of Autointoxication II?

Development of a conceptual policy framework for advanced practice nursing: an ethnographic study.

PubMed

Schober, Madrean M; Gerrish, Kate; McDonnell, Ann

2016-06-01

To report on a study examining policy development for advanced practice nursing from intent of policy to realization in practice. Inclusion of advanced practice nursing roles in the healthcare workforce is a worldwide trend. Optimal advanced nursing practice requires supportive policies. Little is known about how policy is developed and implemented. Ethnography using an instrumental case study approach was selected to give an in-depth understanding of the experiences of one country (Singapore) to contribute to insight into development elsewhere. The four-phase study was conducted from 2008-2012 and included document analysis (n = 47), interviews with key policy decision makers (n = 12), interviews with nursing managers and medical directors (n = 11), interviews and participant observation with advanced practice nurses (n = 15). Key policymakers in positions of authority were able to promote policy development. However, this was characterized by lack of strategic planning for implementation. A vague understanding by nursing managers and medical directors of policies, the role and its position in the healthcare workforce led to indecision and uncertainty in execution. Advanced practice nurses developed their role based on theory acquired in their academic programme but were unsure what role to assume in practice. Lack of clear guidelines led to unanticipated difficulties for institutions and healthcare systems. Strategic planning could facilitate integration of advanced practice nurses into the healthcare workforce. A Conceptual Policy Framework is proposed as a guide for a coordinated approach to policy development and implementation for advanced practice nursing. © 2016 John Wiley & Sons Ltd.

Advanced helmet tracking technology developments for naval aviation

NASA Astrophysics Data System (ADS)

Brindle, James H.

1996-06-01

There is a critical need across the Services to improve the effectiveness of aircrew within the crewstation by capitalizing on the natural psycho-motor skills of the pilot through the use of a variety of helmet-mounted visual display and control techniques. This has resulted in considerable interest and significant ongoing research and development efforts on the part of the Navy, as well as the Army and the Air Force, in the technology building blocks associated with this area, such as advanced head position sensing or head tracking technologies, helmet- mounted display optics and electronics, and advanced night vision or image intensification technologies.

RAPADAPTE for rapid guideline development: high-quality clinical guidelines can be rapidly developed with limited resources.

PubMed

Alper, Brian S; Tristan, Mario; Ramirez-Morera, Anggie; Vreugdenhil, Maria M T; Van Zuuren, Esther J; Fedorowicz, Zbys

2016-06-01

Guideline development is challenging, expensive and labor-intensive. A high-quality guideline with 90 recommendations for breast cancer treatment was developed within 6 months with limited resources in Costa Rica. We describe the experience and propose a process others can use and adapt.The ADAPTE method (using existing guidelines to minimize repeating work that has been done) was used but existing guidelines were not current. The method was extended to use databases that systematically identify, appraise and synthesize evidence for clinical application (DynaMed, EBM Guidelines) to provide current evidence searches and critical appraisal of evidence. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the quality of evidence and the strength of recommendations. Draft recommendations with supporting evidence were provided to panel members for facilitated voting to target panel discussion to areas necessary for reaching consensus.Training panelists in guideline development methodology facilitated rapid consensus development. Extending 'guideline adaptation' to 'evidence database adaptation' was highly effective and efficient. Methods were created to simplify mapping DynaMed evidence ratings to GRADE ratings. Twelve steps are presented to facilitate rapid guideline development and enable further adaptation by others.This is a case report and the RAPADAPTE method was retrospectively derived. Prospective replication and validation will support advances for the guideline development community. If guideline development can be accelerated without compromising validity and relevance of the resulting recommendations this would greatly improve our ability to impact clinical care. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Developing a neonatal workforce: role evolution and retention of advanced neonatal nurse practitioners

PubMed Central

Smith, S; Hall, M

2003-01-01

Background: Over the past decade more than 120 advanced neonatal nurse practitioners (ANNPs) have graduated from the Southampton based ANNP programme. Objectives: To determine the scope of practice and evolving role of ANNPs and to identify factors that may affect future recruitment and retention. Method: An open ended structured questionnaire on clinical role, working arrangements, retention and attrition, continuing education, and professional development was sent to 95 ANNPs. Results: A response rate of 83% was achieved. There was an attrition rate of 14%, with most ANNPs remaining in their original seconding unit. Factors considered to be important for role satisfaction included a well defined role, working within a team of ANNPs, appropriate remuneration, and evidence of unit support for both role definition and continuing professional development. Conclusions: Although ANNPs are expensive to both train and employ, this evidence suggests that there is a good return on the investment in terms of retention to the unit and the specialty. Their role incorporates many features of advanced nursing practice as well as providing "value added" neonatal care by merging traditional medical and nursing roles and crossing professional boundaries. In 2004 the manpower challenges for neonatal units will be even more acute; these data confirm that there are effective options available but they require long term strategic planning and investment. PMID:12937050

Improved resident physician confidence with advance care planning after an ambulatory clinic intervention.

PubMed

Tung, Ericka E; Wieland, Mark L; Verdoorn, Brandon P; Mauck, Karen F; Post, Jason A; Thomas, Matthew R; Bundrick, John B; Jaeger, Thomas M; Cha, Stephen S; Thomas, Kris G

2014-05-01

Many primary care providers feel uncomfortable discussing end-of-life care. The aim of this intervention was to assess internal medicine residents' advance care planning (ACP) practices and improve residents' ACP confidence. Residents participated in a facilitated ACP quality improvement workshop, which included an interactive presentation and chart audit of their own patients. Pre- and postintervention surveys assessed resident ACP-related confidence. Only 24% of the audited patients had an advance directive (AD), and 28% of the ACP-documentation was of no clinical utility. Terminally ill patients (odds ratio 2.8, P < .001) were more likely to have an AD. Patients requiring an interpreter were less likely to have participated in ACP. Residents reported significantly improved confidence with ACP and identified important training gaps. Future studies examining the impact on ACP quality are needed.

Liquid Oxygen/Liquid Methane Propulsion and Cryogenic Advanced Development

NASA Technical Reports Server (NTRS)

Klem, Mark D.; Smith, Timothy D.; Wadel, Mary F.; Meyer, Michael L.; Free, James M.; Cikanek, Harry A., III

2011-01-01

Exploration Systems Architecture Study conducted by NASA in 2005 identified the liquid oxygen (LOx)/liquid methane (LCH4) propellant combination as a prime candidate for the Crew Exploration Vehicle Service Module propulsion and for later use for ascent stage propulsion of the lunar lander. Both the Crew Exploration Vehicle and Lunar Lander were part the Constellation architecture, which had the objective to provide global sustained lunar human exploration capability. From late 2005 through the end of 2010, NASA and industry matured advanced development designs for many components that could be employed in relatively high thrust, high delta velocity, pressure fed propulsion systems for these two applications. The major investments were in main engines, reaction control engines, and the devices needed for cryogenic fluid management such as screens, propellant management devices, thermodynamic vents, and mass gauges. Engine and thruster developments also included advanced high reliability low mass igniters. Extensive tests were successfully conducted for all of these elements. For the thrusters and engines, testing included sea level and altitude conditions. This advanced development provides a mature technology base for future liquid oxygen/liquid methane pressure fed space propulsion systems. This paper documents the design and test efforts along with resulting hardware and test results.

Advanced systemic mastocytosis: from molecular and genetic progress to clinical practice.

PubMed

Ustun, Celalettin; Arock, Michel; Kluin-Nelemans, Hanneke C; Reiter, Andreas; Sperr, Wolfgang R; George, Tracy; Horny, Hans-Peter; Hartmann, Karin; Sotlar, Karl; Damaj, Gandhi; Hermine, Olivier; Verstovsek, Srdan; Metcalfe, Dean D; Gotlib, Jason; Akin, Cem; Valent, Peter

2016-10-01

Systemic mastocytosis is a heterogeneous disease characterized by the accumulation of neoplastic mast cells in the bone marrow and other organ organs/tissues. Mutations in KIT, most frequently KIT D816V, are detected in over 80% of all systemic mastocytosis patients. While most systemic mastocytosis patients suffer from an indolent disease variant, some present with more aggressive variants, collectively called "advanced systemic mastocytosis", which include aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic, clonal non mast cell-lineage disease, and mast cell leukemia. Whereas patients with indolent systemic mastocytosis have a near normal life expectancy, patients with advanced systemic mastocytosis have a reduced life expectancy. Although cladribine and interferon-alpha are of benefit in a group of patients with advanced systemic mastocytosis, no curative therapy is available for these patients except possible allogeneic hematopoietic stem cell transplantation. Recent studies have also revealed additional somatic defects (apart from mutations in KIT) in a majority of patients with advanced systemic mastocytosis. These include TET2, SRSF2, ASXL1, RUNX1, JAK2, and/or RAS mutations, which may adversely impact prognosis and survival in particular systemic mastocytosis with an associated hematological neoplasm. In addition, several additional signaling molecules involved in the abnormal proliferation of mast cells in systemic mastocytosis have been identified. These advances have led to a better understanding of the biology of advanced systemic mastocytosis and to the development of new targeted treatment concepts. Herein, we review the biology and pathogenesis of advanced systemic mastocytosis, with a special focus on novel molecular findings as well as current and evolving therapeutic options. Copyright© Ferrata Storti Foundation.

Developing clinical leadership capability.

PubMed

Pintar, Kristi A; Capuano, Terry A; Rosser, Gwendolyn D

2007-01-01

Nursing facilities must be committed to ongoing leadership development and to developing and retaining their staff in the increasingly competitive healthcare market. In this article, the authors share the processes involved in creating a focused small group approach to developing clinical leaders. Programmatic approaches to development, clarity of needs of those targeted for development, individual development plans, external expertise partnerships, and small group session dynamics are discussed. Applications of the process and lessons learned from the program will benefit others in their efforts to enhance organization succession planning, leadership development, group learning, and program administration.

Clinical proteomic biomarkers: relevant issues on study design & technical considerations in biomarker development

PubMed Central

2014-01-01

Biomarker research is continuously expanding in the field of clinical proteomics. A combination of different proteomic–based methodologies can be applied depending on the specific clinical context of use. Moreover, current advancements in proteomic analytical platforms are leading to an expansion of biomarker candidates that can be identified. Specifically, mass spectrometric techniques could provide highly valuable tools for biomarker research. Ideally, these advances could provide with biomarkers that are clinically applicable for disease diagnosis and/ or prognosis. Unfortunately, in general the biomarker candidates fail to be implemented in clinical decision making. To improve on this current situation, a well-defined study design has to be established driven by a clear clinical need, while several checkpoints between the different phases of discovery, verification and validation have to be passed in order to increase the probability of establishing valid biomarkers. In this review, we summarize the technical proteomic platforms that are available along the different stages in the biomarker discovery pipeline, exemplified by clinical applications in the field of bladder cancer biomarker research. PMID:24679154

Towards advanced OCT clinical applications

NASA Astrophysics Data System (ADS)

Kirillin, Mikhail; Panteleeva, Olga; Agrba, Pavel; Pasukhin, Mikhail; Sergeeva, Ekaterina; Plankina, Elena; Dudenkova, Varvara; Gubarkova, Ekaterina; Kiseleva, Elena; Gladkova, Natalia; Shakhova, Natalia; Vitkin, Alex

2015-07-01

In this paper we report on our recent achievement in application of conventional and cross-polarization OCT (CP OCT) modalities for in vivo clinical diagnostics in different medical areas including gynecology, dermatology, and stomatology. In gynecology, CP OCT was employed for diagnosing fallopian tubes and cervix; in dermatology OCT for monitoring of treatment of psoriasis, scleroderma and atopic dermatitis; and in stomatology for diagnosis of oral diseases. For all considered application, we propose and develop different image processing methods which enhance the diagnostic value of the technique. In particular, we use histogram analysis, Fourier analysis and neural networks, thus calculating different tissue characteristics as revealed by OCT's polarization evolution. These approaches enable improved OCT image quantification and increase its resultant diagnostic accuracy.

Integrative clinical genomics of advanced prostate cancer.

PubMed

Robinson, Dan; Van Allen, Eliezer M; Wu, Yi-Mi; Schultz, Nikolaus; Lonigro, Robert J; Mosquera, Juan-Miguel; Montgomery, Bruce; Taplin, Mary-Ellen; Pritchard, Colin C; Attard, Gerhardt; Beltran, Himisha; Abida, Wassim; Bradley, Robert K; Vinson, Jake; Cao, Xuhong; Vats, Pankaj; Kunju, Lakshmi P; Hussain, Maha; Feng, Felix Y; Tomlins, Scott A; Cooney, Kathleen A; Smith, David C; Brennan, Christine; Siddiqui, Javed; Mehra, Rohit; Chen, Yu; Rathkopf, Dana E; Morris, Michael J; Solomon, Stephen B; Durack, Jeremy C; Reuter, Victor E; Gopalan, Anuradha; Gao, Jianjiong; Loda, Massimo; Lis, Rosina T; Bowden, Michaela; Balk, Stephen P; Gaviola, Glenn; Sougnez, Carrie; Gupta, Manaswi; Yu, Evan Y; Mostaghel, Elahe A; Cheng, Heather H; Mulcahy, Hyojeong; True, Lawrence D; Plymate, Stephen R; Dvinge, Heidi; Ferraldeschi, Roberta; Flohr, Penny; Miranda, Susana; Zafeiriou, Zafeiris; Tunariu, Nina; Mateo, Joaquin; Perez-Lopez, Raquel; Demichelis, Francesca; Robinson, Brian D; Schiffman, Marc; Nanus, David M; Tagawa, Scott T; Sigaras, Alexandros; Eng, Kenneth W; Elemento, Olivier; Sboner, Andrea; Heath, Elisabeth I; Scher, Howard I; Pienta, Kenneth J; Kantoff, Philip; de Bono, Johann S; Rubin, Mark A; Nelson, Peter S; Garraway, Levi A; Sawyers, Charles L; Chinnaiyan, Arul M

2015-05-21

Toward development of a precision medicine framework for metastatic, castration-resistant prostate cancer (mCRPC), we established a multi-institutional clinical sequencing infrastructure to conduct prospective whole-exome and transcriptome sequencing of bone or soft tissue tumor biopsies from a cohort of 150 mCRPC affected individuals. Aberrations of AR, ETS genes, TP53, and PTEN were frequent (40%-60% of cases), with TP53 and AR alterations enriched in mCRPC compared to primary prostate cancer. We identified new genomic alterations in PIK3CA/B, R-spondin, BRAF/RAF1, APC, β-catenin, and ZBTB16/PLZF. Moreover, aberrations of BRCA2, BRCA1, and ATM were observed at substantially higher frequencies (19.3% overall) compared to those in primary prostate cancers. 89% of affected individuals harbored a clinically actionable aberration, including 62.7% with aberrations in AR, 65% in other cancer-related genes, and 8% with actionable pathogenic germline alterations. This cohort study provides clinically actionable information that could impact treatment decisions for these affected individuals. Copyright © 2015 Elsevier Inc. All rights reserved.

Integrative clinical genomics of advanced prostate cancer

PubMed Central

Dan, Robinson; Van Allen, Eliezer M.; Wu, Yi-Mi; Schultz, Nikolaus; Lonigro, Robert J.; Mosquera, Juan-Miguel; Montgomery, Bruce; Taplin, Mary-Ellen; Pritchard, Colin C; Attard, Gerhardt; Beltran, Himisha; Abida, Wassim M.; Bradley, Robert K.; Vinson, Jake; Cao, Xuhong; Vats, Pankaj; Kunju, Lakshmi P.; Hussain, Maha; Feng, Felix Y.; Tomlins, Scott A.; Cooney, Kathleen A.; Smith, David C.; Brennan, Christine; Siddiqui, Javed; Mehra, Rohit; Chen, Yu; Rathkopf, Dana E.; Morris, Michael J.; Solomon, Stephen B.; Durack, Jeremy C.; Reuter, Victor E.; Gopalan, Anuradha; Gao, Jianjiong; Loda, Massimo; Lis, Rosina T.; Bowden, Michaela; Balk, Stephen P.; Gaviola, Glenn; Sougnez, Carrie; Gupta, Manaswi; Yu, Evan Y.; Mostaghel, Elahe A.; Cheng, Heather H.; Mulcahy, Hyojeong; True, Lawrence D.; Plymate, Stephen R.; Dvinge, Heidi; Ferraldeschi, Roberta; Flohr, Penny; Miranda, Susana; Zafeiriou, Zafeiris; Tunariu, Nina; Mateo, Joaquin; Lopez, Raquel Perez; Demichelis, Francesca; Robinson, Brian D.; Schiffman, Marc A.; Nanus, David M.; Tagawa, Scott T.; Sigaras, Alexandros; Eng, Kenneth W.; Elemento, Olivier; Sboner, Andrea; Heath, Elisabeth I.; Scher, Howard I.; Pienta, Kenneth J.; Kantoff, Philip; de Bono, Johann S.; Rubin, Mark A.; Nelson, Peter S.; Garraway, Levi A.; Sawyers, Charles L.; Chinnaiyan, Arul M.

2015-01-01

SUMMARY Toward development of a precision medicine framework for metastatic, castration resistant prostate cancer (mCRPC), we established a multi-institutional clinical sequencing infrastructure to conduct prospective whole exome and transcriptome sequencing of bone or soft tissue tumor biopsies from a cohort of 150 mCRPC affected individuals. Aberrations of AR, ETS genes, TP53 and PTEN were frequent (40–60% of cases), with TP53 and AR alterations enriched in mCRPC compared to primary prostate cancer. We identified novel genomic alterations in PIK3CA/B, R-spondin, BRAF/RAF1, APC, β-catenin and ZBTB16/PLZF. Aberrations of BRCA2, BRCA1 and ATM were observed at substantially higher frequencies (19.3% overall) than seen in primary prostate cancers. 89% of affected individuals harbored a clinically actionable aberration including 62.7% with aberrations in AR, 65% in other cancer-related genes, and 8% with actionable pathogenic germline alterations. This cohort study provides evidence that clinical sequencing in mCRPC is feasible and could impact treatment decisions in significant numbers of affected individuals. PMID:26000489

Development of Nanosized/Nanostructured Silicon as Advanced Anodes for Lithium-Ion Cells

NASA Technical Reports Server (NTRS)

Wu, James J.

2015-01-01

NASA is developing high energy and high capacity Li-ion cell and battery designs for future exploration missions under the NASA Advanced Space Power System (ASPS) Program. The specific energy goal is 265 Wh/kg at 10 C. center dot Part of effort for NASA advanced Li-ion cells ? Anode: Silicon (Si) as an advanced anode. ? Electrolyte: advanced electrolyte with flame-retardant additives for enhanced performance and safety (NASA JPL).

Advances in Robotic Servicing Technology Development

NASA Technical Reports Server (NTRS)

Gefke, Gardell G.; Janas, Alex; Pellegrino, Joseph; Sammons, Matthew; Reed, Benjamin

2015-01-01

NASA's Satellite Servicing Capabilities Office (SSCO) has matured robotic and automation technologies applicable to in-space robotic servicing and robotic exploration over the last six years. This paper presents the progress of technology development activities at the Goddard Space Flight Center Servicing Technology Center and on the ISS, with an emphasis on those occurring in the past year. Highlighted advancements are design reference mission analysis for servicing in low Earth orbit (LEO) and near Earth asteroid boulder retrieval; delivery of the engineering development unit of the NASA Servicing Arm; an update on International Space Station Robotic Refueling Mission; and status of a comprehensive ground-based space robot technology demonstration expanding in-space robotic servicing capabilities beginning fall 2015.

Advances in Robotic Servicing Technology Development

NASA Technical Reports Server (NTRS)

Gefke, Gardell G.; Janas, Alex; Pellegrino, Joseph; Sammons, Matthew; Reed, Benjamin

2015-01-01

NASA's Satellite Servicing Capabilities Office (SSCO) has matured robotic and automation technologies applicable to in-space robotic servicing and robotic exploration over the last six years. This paper presents the progress of technology development activities at the Goddard Space Flight Center Servicing Technology Center and on the ISS, with an emphasis on those occurring in the past year. Highlighted advancements are design reference mission analysis for servicing in low Earth orbit (LEO) and asteroid redirection; delivery of the engineering development unit of the NASA Servicing Arm; an update on International Space Station Robotic Refueling Mission; and status of a comprehensive ground-based space robot technology demonstration expanding in-space robotic servicing capabilities beginning fall 2015.

From challenges to advanced practice registered nursing role development: Qualitative interview study.

PubMed

Jokiniemi, Krista; Haatainen, Kaisa; Pietilä, Anna-Maija

2015-12-01

The aim of this study is to describe the factors hindering and facilitating the implementation of the advanced practice registered nurses role at Finnish university hospitals, and to examine the implications for its future development. A descriptive qualitative approach, using thematic individual interviews, was conducted in 2011 with a sample of 11 advanced practice registered nurses. The data were analysed using qualitative content analysis. The advanced practice registered nurses role barriers had an impact on the role development needs. In turn, the facilitating factors helped encounter the challenges of the role, therefore having an impact on both the current role achievement, as well as contributing to the future role development. The factors hindering and facilitating the advanced practice registered nurses role need to be acknowledged to support the role implementation and planning of the future of the role. © 2014 Wiley Publishing Asia Pty Ltd.

Parental consanguineous marriages and clinical response to chemotherapy in locally advanced breast cancer patients.

PubMed

Saadat, Mostafa; Khalili, Maryam; Omidvari, Shahpour; Ansari-Lari, Maryam

2011-03-28

The main aim of the present study was investigating the association between parental consanguinity and clinical response to chemotherapy in females affected with locally advanced breast cancer. A consecutive series of 92 patients were prospectively included in this study. Clinical assessment of treatment was accomplished by comparing initial tumor size with preoperative tumor size using revised RECIST guideline (version 1.1). Clinical response defined as complete response, partial response and no response. The Kaplan-Meier survival analysis were used to evaluate the association of parental marriages (first cousin vs unrelated marriages) and clinical response to chemotherapy (complete and partial response vs no response). Number of courses of chemotherapy was considered as time, in the analysis. Kaplan-Meier analysis revealed that offspring of unrelated marriages had poorer response to chemotherapy (log rank statistic=5.10, df=1, P=0.023). Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Plasma genetic and genomic abnormalities predict treatment response and clinical outcome in advanced prostate cancer.

PubMed

Xia, Shu; Kohli, Manish; Du, Meijun; Dittmar, Rachel L; Lee, Adam; Nandy, Debashis; Yuan, Tiezheng; Guo, Yongchen; Wang, Yuan; Tschannen, Michael R; Worthey, Elizabeth; Jacob, Howard; See, William; Kilari, Deepak; Wang, Xuexia; Hovey, Raymond L; Huang, Chiang-Ching; Wang, Liang

2015-06-30

Liquid biopsies, examinations of tumor components in body fluids, have shown promise for predicting clinical outcomes. To evaluate tumor-associated genomic and genetic variations in plasma cell-free DNA (cfDNA) and their associations with treatment response and overall survival, we applied whole genome and targeted sequencing to examine the plasma cfDNAs derived from 20 patients with advanced prostate cancer. Sequencing-based genomic abnormality analysis revealed locus-specific gains or losses that were common in prostate cancer, such as 8q gains, AR amplifications, PTEN losses and TMPRSS2-ERG fusions. To estimate tumor burden in cfDNA, we developed a Plasma Genomic Abnormality (PGA) score by summing the most significant copy number variations. Cox regression analysis showed that PGA scores were significantly associated with overall survival (p < 0.04). After androgen deprivation therapy or chemotherapy, targeted sequencing showed significant mutational profile changes in genes involved in androgen biosynthesis, AR activation, DNA repair, and chemotherapy resistance. These changes may reflect the dynamic evolution of heterozygous tumor populations in response to these treatments. These results strongly support the feasibility of using non-invasive liquid biopsies as potential tools to study biological mechanisms underlying therapy-specific resistance and to predict disease progression in advanced prostate cancer.

Improving the clinical assessment of consciousness with advances in electrophysiological and neuroimaging techniques

PubMed Central

2010-01-01

In clinical neurology, a comprehensive understanding of consciousness has been regarded as an abstract concept - best left to philosophers. However, times are changing and the need to clinically assess consciousness is increasingly becoming a real-world, practical challenge. Current methods for evaluating altered levels of consciousness are highly reliant on either behavioural measures or anatomical imaging. While these methods have some utility, estimates of misdiagnosis are worrisome (as high as 43%) - clearly this is a major clinical problem. The solution must involve objective, physiologically based measures that do not rely on behaviour. This paper reviews recent advances in physiologically based measures that enable better evaluation of consciousness states (coma, vegetative state, minimally conscious state, and locked in syndrome). Based on the evidence to-date, electroencephalographic and neuroimaging based assessments of consciousness provide valuable information for evaluation of residual function, formation of differential diagnoses, and estimation of prognosis. PMID:20113490

A Strategic Approach for Developing an Advanced Practice Workforce: From Postgraduate Transition-to-Practice Fellowship Programs and Beyond.

PubMed

Taylor, Dennis A; Broyhill, Britney S; Burris, Allison M; Wilcox, Mary Ann

The healthcare provider landscape is rapidly changing. Given the imminent retirement of baby boomer physicians, implementation of the Affordable Care Act, and the increased utilization of health care services by an ever-aging population, the supply of providers cannot keep pace with the demand for services. This has led to an increased utilization of advanced clinical practitioners (ACPs). This article shows how one large highly-matrixed health care system approached identifying this workforce, and how thought leaders worked collaboratively with physicians, administrators, and ACPs to meet a growing demand for providers. Carolinas HealthCare System developed a 3-pronged approach to this opportunity. The development of a Center for Advanced Practice was explored and implemented. This Center serves as a 2-way conduit of information and ideas between system administrators and providers. It also serves as a central source of regulatory and practice information for administrators and providers. The growing number of open ACP positions, along with the reluctance to employ novice and new graduate ACPs, led to the development of a postgraduate transition to practice fellowship program. This program's clinical tracks and curriculum are described. Finally, a collaborative effort between the health care system and a local university resulted in the local offering of an acute care nurse practitioner program, which allowed system nurses to continue their education without the need for relocation. Higher satisfaction and engagement, lower turnover, better career opportunities, more satisfied administrators, and physicians all contributed to the overwhelming success of this initiative.

Recent Advances in Gastrointestinal Stent Development

PubMed Central

Park, Jin-Seok; Jeong, Seok

2015-01-01

Endoscopic stenting is increasingly being used in the management of gastrointestinal luminal obstruction, and has become the current treatment of choice for the palliation of blockage caused by malignant or benign growths. A variety of stents have been developed to enhance the efficacy of the procedure, and improvements are ongoing. In this article, we review the history of, and recent advances in, gastrointestinal stenting. We describe the rationale behind the design as well as the resulting outcome for each stent type. PMID:26064820

Hydrogen-bromine fuel cell advance component development

NASA Technical Reports Server (NTRS)

Charleston, Joann; Reed, James

1988-01-01

Advanced cell component development is performed by NASA Lewis to achieve improved performance and longer life for the hydrogen-bromine fuel cells system. The state-of-the-art hydrogen-bromine system utilizes the solid polymer electrolyte (SPE) technology, similar to the SPE technology developed for the hydrogen-oxygen fuel cell system. These studies are directed at exploring the potential for this system by assessing and evaluating various types of materials for cell parts and electrode materials for Bromine-hydrogen bromine environment and fabricating experimental membrane/electrode-catalysts by chemical deposition.

Clinical Pharmacy Consultations Provided by American and Kenyan Pharmacy Students During an Acute Care Advanced Pharmacy Practice Experience

PubMed Central

Pastakia, Sonak D.; Manji, Imran; Kamau, Evelyn; Schellhase, Ellen M.

2011-01-01

Objective To compare the clinical consultations provided by American and Kenyan pharmacy students in an acute care setting in a developing country. Methods The documented pharmacy consultation recommendations made by American and Kenyan pharmacy students during patient care rounds on an advanced pharmacy practice experience at a referral hospital in Kenya were reviewed and classified according to type of intervention and therapeutic area. Results The Kenyan students documented more interventions than American students (16.7 vs. 12.0 interventions/day) and provided significantly more consultations regarding human immunodeficiency virus (HIV) and antibiotics. The top area of consultations provided by American students was cardiovascular diseases. Conclusions American and Kenyan pharmacy students successfully providing clinical pharmacy consultations in a resource-constrained, acute-care practice setting suggests an important role for pharmacy students in the reconciliation of prescriber orders with medication administration records and in providing drug information. PMID:21655396

Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials

PubMed Central

Bekelman, Justin E.; Deye, James A.; Vikram, Bhadrasain; Bentzen, Soren M.; Bruner, Deborah; Curran, Walter J.; Dignam, James; Efstathiou, Jason A.; FitzGerald, T. J.; Hurkmans, Coen; Ibbott, Geoffrey S.; Lee, J. Jack; Merchant, Timothy E.; Michalski, Jeff; Palta, Jatinder R.; Simon, Richard; Ten Haken, Randal K.; Timmerman, Robert; Tunis, Sean; Coleman, C. Norman; Purdy, James

2012-01-01

Background In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute (NCI) sponsored a two day workshop to examine the challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. Lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities like proton beam therapy, and the international harmonization of clinical trial QA. Results Four recommendations were made: 1) Develop a tiered (and more efficient) system for radiotherapy QA and tailor intensity of QA to clinical trial objectives. Tiers include (i) general credentialing, (ii) trial specific credentialing, and (iii) individual case review; 2) Establish a case QA repository; 3) Develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and 4) Explore the feasibility of consolidating clinical trial QA in the United States. Conclusion Radiotherapy QA may impact clinical trial accrual, cost, outcomes and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. PMID:22425219

Developing a clinically viable angle-resolved low coherence interferometry optical biopsy system

NASA Astrophysics Data System (ADS)

Pyhtila, John W.

2007-12-01

Non-invasive optical biopsy techniques, which interrogate tissue in situ, offer a potential method to improve the detection of dysplasia, a pre-cancerous tissue state. Specifically, monitoring of Barrett's esophagus (BE) patients for dysplasia, currently done through systematic biopsy, can be improved by increasing the proportion of at-risk tissue examined. Angle-resolved low coherence interferometry (a/LCI) is an optical spectroscopic technique which measures the depth resolved nuclear morphology of tissue, a key biomarker for identifying dysplasia. Using an animal carcinogenesis model, it was shown that a/LCI can detect dysplasia with great sensitivity and specificity. However, for the clinical application of a/LCI, numerous hurdles must be overcome. This dissertation presents the development of three new a/LCI systems which incrementally address the three main obstacles preventing the clinical application of a/LCI. First, data acquisition time is reduced by implementing a frequency-domain detection scheme using an imaging spectrograph that collects the complete depth resolved angular scattering distribution in parallel. This advance reduces data collection time to a clinically acceptable 40 ms. Second, a fiber probe is developed to enable the endoscopic application of a/LCI. The probe incorporates a single fiber for delivering light and a coherent fiber bundle for collecting the angular distribution of scattered light. Third, a portable device is created through miniaturization of the optical design, and a flexible fiber probe is created using polarization maintaining fiber to deliver the light. These advances allow for the clinical application of the system to ex vivo human tissue samples. The performance of each described system is evaluated through a number of validation studies, including the sizing of polystyrene microspheres, a typical model used in light scattering studies, and the measurement of in vitro cell nuclear diameters, accomplished with sub

Development of regional chemotherapies: feasibility, safety and efficacy in clinical use and preclinical studies

PubMed Central

Cai, Shuang; Bagby, Taryn R; Forrest, M Laird

2011-01-01

Conventional oral and intravenous chemotherapies permeate throughout the body, exposing healthy tissues to similar cytotoxic drug levels as tumors. This leads to significant dose-limiting toxicities that may prevent patients from receiving sufficient treatment to overcome cancers. Therefore, a number of locoregional drug-delivery strategies have been evaluated and implemented in preclinical studies, clinical trials and in practice, in the past decades to minimize systemic toxicities from chemotherapeutic agents and to improve treatment outcomes. Localized treatment is beneficial because many cancers, such as melanoma, peritoneal cancer and breast cancer, advance locally adjacent to the site of the primary tumors prior to their circulatory invasion. In this article, we will review the feasibility, safety and efficacy of multiple localized chemotherapies in clinical use and preclinical development. PMID:22229080

Development of Advanced Low Conductivity Thermal Barrier Coatings

NASA Technical Reports Server (NTRS)

Zhu, Dong-Ming; Miller, Robert A.

2004-01-01

Advanced multi-component, low conductivity oxide thermal barrier coatings have been developed using an approach that emphasizes real-time monitoring of thermal conductivity under conditions that are engine-like in terms of temperatures and heat fluxes. This is in contrast to the traditional approach where coatings are initially optimized in terms of furnace and burner rig durability with subsequent measurement in the as-processed or furnace-sintered condition. The present work establishes a laser high-heat-flux test as the basis for evaluating advanced plasma-sprayed and electron beam-physical vapor deposited (EB-PVD) thermal barrier coatings under the NASA Ultra-Efficient Engine Technology (UEET) Program. The candidate coating materials for this program are novel thermal barrier coatings that are found to have significantly reduced thermal conductivities and improved thermal stability due to an oxide-defect-cluster design. Critical issues for designing advanced low conductivity coatings with improved coating durability are also discussed.

Development of Metal Matrix Composites for NASA'S Advanced Propulsion Systems

NASA Technical Reports Server (NTRS)

Lee, Jonathan A.

2000-01-01

The state-of-the-art development of several aluminum and copper based Metal Matrix Composites (MMC) for NASA's advanced propulsion systems will be presented. The presentation's goal is to provide an overview of NASA-Marshall Space Flight Center's planned and on-going activities in MMC for advanced liquid rocket engines such as the X-33 vehicle's Aerospike and X-34 Fastrac engine. The focus will be on lightweight and environmental compatibility with oxygen and hydrogen of key MMC materials, within each NASA's new propulsion application, that will provide a high payoff for NASA's reusable launch vehicle systems and space access vehicles. Advanced MMC processing techniques such as plasma spray, centrifugal casting, pressure infiltration casting will be discussed. Development of a novel 3D printing method for low cost production of composite preform, and functional gradient MMC to enhanced rocket engine's dimensional stability will be presented.

A randomized, controlled trial of in situ pediatric advanced life support recertification ("pediatric advanced life support reconstructed") compared with standard pediatric advanced life support recertification for ICU frontline providers*.

PubMed

Kurosawa, Hiroshi; Ikeyama, Takanari; Achuff, Patricia; Perkel, Madeline; Watson, Christine; Monachino, Annemarie; Remy, Daphne; Deutsch, Ellen; Buchanan, Newton; Anderson, Jodee; Berg, Robert A; Nadkarni, Vinay M; Nishisaki, Akira

2014-03-01

Recent evidence shows poor retention of Pediatric Advanced Life Support provider skills. Frequent refresher training and in situ simulation are promising interventions. We developed a "Pediatric Advanced Life Support-reconstructed" recertification course by deconstructing the training into six 30-minute in situ simulation scenario sessions delivered over 6 months. We hypothesized that in situ Pediatric Advanced Life Support-reconstructed implementation is feasible and as effective as standard Pediatric Advanced Life Support recertification. A prospective randomized, single-blinded trial. Single-center, large, tertiary PICU in a university-affiliated children's hospital. Nurses and respiratory therapists in PICU. Simulation-based modular Pediatric Advanced Life Support recertification training. Simulation-based pre- and postassessment sessions were conducted to evaluate participants' performance. Video-recorded sessions were rated by trained raters blinded to allocation. The primary outcome was skill performance measured by a validated Clinical Performance Tool, and secondary outcome was behavioral performance measured by a Behavioral Assessment Tool. A mixed-effect model was used to account for baseline differences. Forty participants were prospectively randomized to Pediatric Advanced Life Support reconstructed versus standard Pediatric Advanced Life Support with no significant difference in demographics. Clinical Performance Tool score was similar at baseline in both groups and improved after Pediatric Advanced Life Support reconstructed (pre, 16.3 ± 4.1 vs post, 22.4 ± 3.9; p < 0.001), but not after standard Pediatric Advanced Life Support (pre, 14.3 ± 4.7 vs post, 14.9 ± 4.4; p =0.59). Improvement of Clinical Performance Tool was significantly higher in Pediatric Advanced Life Support reconstructed compared with standard Pediatric Advanced Life Support (p = 0.006). Behavioral Assessment Tool improved in both groups: Pediatric Advanced Life Support

Harsh environment sensor development for advanced energy systems

NASA Astrophysics Data System (ADS)

Romanosky, Robert R.; Maley, Susan M.

2013-05-01

Highly efficient, low emission power systems have extreme conditions of high temperature, high pressure, and corrosivity that require monitoring. Sensing in these harsh environments can provide key information that directly impacts process control and system reliability. To achieve the goals and demands of clean energy, the conditions under which fossil fuels are converted into heat and power are harsh compared to traditional combustion/steam cycles. Temperatures can extend as high as 1600 Celsius (°C) in certain systems and pressures can reach as high as 5000 pounds per square inch (psi)/340 atmospheres (atm). The lack of suitable measurement technology serves as a driver for the innovations in harsh environment sensor development. Two major considerations in the development of harsh environments sensors are the materials used for sensing and the design of the sensing device. This paper will highlight the U.S. Department of Energy's, Office of Fossil Energy and National Energy Technology Laboratory's Program in advanced sensing concepts that are aimed at addressing the technology needs and drivers through the development of new sensor materials and designs capable of withstanding harsh environment conditions. Recent developments with harsh environment sensors will be highlighted and future directions towards in advanced sensing will be introduced.

Advanced Life Support Research and Technology Development Metric

NASA Technical Reports Server (NTRS)

Hanford, A. J.

2004-01-01

The Metric is one of several measures employed by the NASA to assess the Agency s progress as mandated by the United States Congress and the Office of Management and Budget. Because any measure must have a reference point, whether explicitly defined or implied, the Metric is a comparison between a selected ALS Project life support system and an equivalently detailed life support system using technology from the Environmental Control and Life Support System (ECLSS) for the International Space Station (ISS). This document provides the official calculation of the Advanced Life Support (ALS) Research and Technology Development Metric (the Metric) for Fiscal Year 2004. The values are primarily based on Systems Integration, Modeling, and Analysis (SIMA) Element approved software tools or reviewed and approved reference documents. For Fiscal Year 2004, the Advanced Life Support Research and Technology Development Metric value is 2.03 for an Orbiting Research Facility and 1.62 for an Independent Exploration Mission.

Advances in endodontics: Potential applications in clinical practice

PubMed Central

Kishen, Anil; Peters, Ove A.; Zehnder, Matthias; Diogenes, Anibal R.; Nair, Madhu K.

2016-01-01

Contemporary endodontics has seen an unprecedented advance in technology and materials. This article aimed to review some of the challenges and advances in the following sections: (1) endodontic imaging, (2) root canal preparation, (3) root canal disinfection, (4) root canal filling, and (4) regenerative endodontic procedures (REPs). Jointly, these advances are aimed at improving the state of the art and science of root canal treatment. PMID:27217630

Advanced image fusion algorithms for Gamma Knife treatment planning. Evaluation and proposal for clinical use.

PubMed

Apostolou, N; Papazoglou, Th; Koutsouris, D

2006-01-01

Image fusion is a process of combining information from multiple sensors. It is a useful tool implemented in the treatment planning programme of Gamma Knife Radiosurgery. In this paper we evaluate advanced image fusion algorithms for Matlab platform and head images. We develop nine level grayscale image fusion methods: average, principal component analysis (PCA), discrete wavelet transform (DWT) and Laplacian, filter - subtract - decimate (FSD), contrast, gradient, morphological pyramid and a shift invariant discrete wavelet transform (SIDWT) method in Matlab platform. We test these methods qualitatively and quantitatively. The quantitative criteria we use are the Root Mean Square Error (RMSE), the Mutual Information (MI), the Standard Deviation (STD), the Entropy (H), the Difference Entropy (DH) and the Cross Entropy (CEN). The qualitative are: natural appearance, brilliance contrast, presence of complementary features and enhancement of common features. Finally we make clinically useful suggestions.

Repurposing of Clinically Developed Drugs for Treatment of Middle East Respiratory Syndrome Coronavirus Infection

PubMed Central

Dyall, Julie; Coleman, Christopher M.; Hart, Brit J.; Venkataraman, Thiagarajan; Holbrook, Michael R.; Kindrachuk, Jason; Johnson, Reed F.; Olinger, Gene G.; Jahrling, Peter B.; Laidlaw, Monique; Johansen, Lisa M.; Lear-Rooney, Calli M.; Glass, Pamela J.; Hensley, Lisa E.

2014-01-01

Outbreaks of emerging infections present health professionals with the unique challenge of trying to select appropriate pharmacologic treatments in the clinic with little time available for drug testing and development. Typically, clinicians are left with general supportive care and often untested convalescent-phase plasma as available treatment options. Repurposing of approved pharmaceutical drugs for new indications presents an attractive alternative to clinicians, researchers, public health agencies, drug developers, and funding agencies. Given the development times and manufacturing requirements for new products, repurposing of existing drugs is likely the only solution for outbreaks due to emerging viruses. In the studies described here, a library of 290 compounds was screened for antiviral activity against Middle East respiratory syndrome coronavirus (MERS-CoV) and severe acute respiratory syndrome coronavirus (SARS-CoV). Selection of compounds for inclusion in the library was dependent on current or previous FDA approval or advanced clinical development. Some drugs that had a well-defined cellular pathway as target were included. In total, 27 compounds with activity against both MERS-CoV and SARS-CoV were identified. The compounds belong to 13 different classes of pharmaceuticals, including inhibitors of estrogen receptors used for cancer treatment and inhibitors of dopamine receptor used as antipsychotics. The drugs identified in these screens provide new targets for in vivo studies as well as incorporation into ongoing clinical studies. PMID:24841273

Solar Concentrator Advanced Development Program, Task 1

NASA Technical Reports Server (NTRS)

1986-01-01

Solar dynamic power generation has been selected by NASA to provide power for the space station. Solar dynamic concentrator technology has been demonstrated for terrestrial applications but has not been developed for space applications. The object of the Solar Concentrator Advanced Development program is to develop the technology of solar concentrators which would be used on the space station. The first task of this program was to develop conceptual concentrator designs and perform trade-off studies and to develop a materials data base and perform material selection. Three unique concentrator concepts; Truss Hex, Spline Radial Panel and Domed Fresnel, were developed and evaluated against weighted trade criteria. The Truss Hex concept was recommended for the space station. Materials data base development demonstrated that several material systems are capable of withstanding extended periods of atomic oxygen exposure without undesirable performance degradation. Descriptions of the conceptual designs and materials test data are included.

Laser light scattering instrument advanced technology development

NASA Technical Reports Server (NTRS)

Wallace, J. F.

1993-01-01

The objective of this advanced technology development (ATD) project has been to provide sturdy, miniaturized laser light scattering (LLS) instrumentation for use in microgravity experiments. To do this, we assessed user requirements, explored the capabilities of existing and prospective laser light scattering hardware, and both coordinated and participated in the hardware and software advances needed for a flight hardware instrument. We have successfully breadboarded and evaluated an engineering version of a single-angle glove-box instrument which uses solid state detectors and lasers, along with fiber optics, for beam delivery and detection. Additionally, we have provided the specifications and written verification procedures necessary for procuring a miniature multi-angle LLS instrument which will be used by the flight hardware project which resulted from this work and from this project's interaction with the laser light scattering community.

Clinical and histological determinants of nonalcoholic steatohepatitis and advanced fibrosis in elderly patients.

PubMed

Noureddin, Mazen; Yates, Katherine P; Vaughn, Ivana A; Neuschwander-Tetri, Brent A; Sanyal, Arun J; McCullough, Arthur; Merriman, Raphael; Hameed, Bilal; Doo, Edward; Kleiner, David E; Behling, Cynthia; Loomba, Rohit

2013-11-01

The characteristics of nonalcoholic fatty liver disease (NAFLD) in elderly patients are unknown. Therefore, we aimed to examine the differences between elderly and nonelderly patients with NAFLD and to identify determinants of nonalcoholic steatohepatitis (NASH) and advanced fibrosis (bridging fibrosis or cirrhosis) in elderly patients. This is a cross-sectional analysis of adult participants who were prospectively enrolled in the NASH Clinical Research Network studies. Participants were included based on availability of the centrally reviewed liver histology data within 1 year of enrollment, resulting in 61 elderly (age ≥65 years) and 735 nonelderly (18-64 years) participants. The main outcomes were the presence of NASH and advanced fibrosis. Compared to nonelderly patients with NAFLD, elderly patients had a higher prevalence of NASH (56% versus 72%, P = 0.02), and advanced fibrosis (25% versus 44%, P = 0.002). Compared to nonelderly patients with NASH, elderly patients with NASH had higher rates of advanced fibrosis (35% versus 52%, P = 0.03), as well as other features of severe liver disease including the presence of ballooning degeneration, acidophil bodies, megamitochondria, and Mallory-Denk bodies (P ≤ 0.05 for each). In multiple logistic regression analyses, independent determinants of NASH in elderly patients included higher aspartate aminotransferase (AST) (odds ratio [OR] = 1.12, P = 0.007) and lower platelets (OR = 0.98, P = 0.02); and independent determinants of advanced fibrosis included higher AST (OR = 1.08, P = 0.007), lower alanine aminotransferase value (OR = 0.91, P = 0.002), and an increased odds of having low high-density lipoprotein (OR = 8.35, P = 0.02). Elderly patients are more likely to have NASH and advanced fibrosis than nonelderly patients with NAFLD. Liver biopsy may be considered in elderly patients and treatment should be initiated in those with NASH and advanced fibrosis. �

Development of advanced lightweight containment systems

NASA Technical Reports Server (NTRS)

Stotler, C.

1981-01-01

Parametric type data were obtained on advanced lightweight containment systems. These data were used to generate design methods and procedures necessary for the successful development of such systems. The methods were then demonstrated through the design of a lightweight containment system for a CF6 size engine. The containment concept evaluated consisted basically of a lightweight structural sandwich shell wrapped with dry Kevlar cloth. The initial testing was directed towards the determination of the amount of Kevlar required to result in threshold containment for a specific set of test conditions. A relationship was then developed between the thickness required and the energy of the released blade so that the data could be used to design for conditions other than those tested.

Development of advanced therapies in Italy: Management models and sustainability in six Italian cell factories.

PubMed

Gaipa, Giuseppe; Introna, Martino; Golay, Josee; Nolli, Maria Luisa; Vallanti, Giuliana; Parati, Eugenio; Giordano, Rosaria; Romagnoli, Luca; Melazzini, Mario; Biondi, Andrea; Biagi, Ettore

2016-04-01

On November 10, 2014, the representatives of all six certified Good Manufacturing Practices (GMP) cell factories operating in the Lombardy Region of Italy convened a 1-day workshop in Milan titled "Management Models for the Development And Sustainability of Cell Factories: Public-Private Partnership?" The speakers and panelists addressed not only the many scientific, technological and cultural challenges faced by Lombardy Cell Factories, but also the potential impact of advanced therapy medicinal products (ATMPs) on public health and the role played by translational research in this process. Future perspectives for research and development (R&D) and manufacturing processes in the field of regenerative medicine were discussed as well. This report summarizes the most important issues raised by the workshop participants with particular emphasis on strengths and limitations of the R&D and manufacturing processes for innovative therapeutics in Lombardy and what can be improved in this context while maintaining GMP standards. The participants highlighted several strategies to translate patient-specific advanced therapeutics into scaled manufacturing products for clinical application. These included (i) the development of a synergistic interaction between public and private institutions, (ii) better integration with Italian regulatory agencies and (iii) the creation of a network among Lombardy cell factories and other Italian and European institutions. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Driving CT developments the last mile: case examples of successful and somewhat less successful translations into clinical practice

NASA Astrophysics Data System (ADS)

Sodickson, Aaron D.

2017-03-01

CT technology has advanced rapidly in recent years, yet not all innovations translate readily into clinical practice. Technology advances must meet certain key requirements to make it into routine use: They must provide a well-defined clinical benefit. They must be easy to use and integrate readily into existing workflows, or better still, further streamline these workflows. These requirements heavily favor fully integrated or automated solutions that remove the human factor and provide a reproducible output independent of operator skill level. Further, to achieve these aims, collaboration with the ultimate end users is needed as early as possible in the development cycle, not just at the point of product testing. Technology innovators are encouraged to engage such collaborators even at early stages of feature or product definition. This manuscript highlights these concepts through exploration of challenging areas in CT imaging in an Emergency Department setting. Technique optimization for pulmonary embolus CT is described as an example of successful integration of multiple advances in radiation dose reduction and imaging speed. The typical workflow of a trauma "pan-scan" (incorporating scans from head through pelvis) is described to highlight workflow challenges and opportunities for improvement. Finally, Dual Energy CT is discussed to highlight the undeniable clinical value of the material characterization it provides, yet also its surprisingly slow integration into routine use beyond early adopters.

Conceptual definition of a technology development mission for advanced solar dynamic power systems

NASA Technical Reports Server (NTRS)

Migra, R. P.

1986-01-01

An initial conceptual definition of a technology development mission for advanced solar dynamic power systems is provided, utilizing a space station to provide a dedicated test facility. The advanced power systems considered included Brayton, Stirling, and liquid metal Rankine systems operating in the temperature range of 1040 to 1400 K. The critical technologies for advanced systems were identified by reviewing the current state of the art of solar dynamic power systems. The experimental requirements were determined by planning a system test of a 20 kWe solar dynamic power system on the space station test facility. These requirements were documented via the Mission Requirements Working Group (MRWG) and Technology Development Advocacy Group (TDAG) forms. Various concepts or considerations of advanced concepts are discussed. A preliminary evolutionary plan for this technology development mission was prepared.

Advanced Gas Turbine (AGT) Technology Development Project, ceramic component developments

NASA Technical Reports Server (NTRS)

Teneyck, M. O.; Macbeth, J. W.; Sweeting, T. B.

1987-01-01

The ceramic component technology development activity conducted by Standard Oil Engineered Materials Company while performing as a principal subcontractor to the Garrett Auxiliary Power Division for the Advanced Gas Turbine (AGT) Technology Development Project (NASA Contract DEN3-167) is summarized. The report covers the period October 1979 through July 1987, and includes information concerning ceramic technology work categorized as common and unique. The former pertains to ceramic development applicable to two parallel AGT projects established by NASA contracts DEN3-168 (AGT100) and DEN3-167 (AGT101), whereas the unique work solely pertains to Garrett directed activity under the latter contract. The AGT101 Technology Development Project is sponsored by DOE and administered by NASA-Lewis. Standard Oil directed its efforts toward the development of ceramic materials in the silicon-carbide family. Various shape forming and fabrication methods, and nondestructive evaluation techniques were explored to produce the static structural components for the ceramic engine. This permitted engine testing to proceed without program slippage.

Recent advances in bioelectric prostheses

PubMed Central

Pasquina, Paul F.; Perry, Briana N.; Miller, Matthew E.; Ling, Geoffrey S.F.; Tsao, Jack W.

2015-01-01

Summary Worldwide prevalence of amputation has created an increasing demand for improved upper and lower extremity prostheses. Current prosthetics are often uncomfortable and difficult to control and provide limited functional restoration. Moreover, the inability to normalize anthropomorphic biomechanics with a prosthesis increases one's risk of developing long-term health risks such as arthritis, skin breakdown, and pain. Recent advances in bionic prosthetic development hold great promise for rehabilitation and improving quality of life with limb loss. This brief review discusses the current state of advanced prostheses, the integration of robotics in the care of individuals with major limb amputation, and some innovative surgical techniques that are being explored for clinical feasibility. PMID:29443190

Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial.

PubMed

Margulies, Kenneth B; Hernandez, Adrian F; Redfield, Margaret M; Givertz, Michael M; Oliveira, Guilherme H; Cole, Robert; Mann, Douglas L; Whellan, David J; Kiernan, Michael S; Felker, G Michael; McNulty, Steven E; Anstrom, Kevin J; Shah, Monica R; Braunwald, Eugene; Cappola, Thomas P

2016-08-02

Abnormal cardiac metabolism contributes to the pathophysiology of advanced heart failure with reduced left ventricular ejection fraction (LVEF). Glucagon-like peptide 1 (GLP-1) agonists have shown cardioprotective effects in early clinical studies of patients with advanced heart failure, irrespective of type 2 diabetes status. To test whether therapy with a GLP-1 agonist improves clinical stability following hospitalization for acute heart failure. Phase 2, double-blind, placebo-controlled randomized clinical trial of patients with established heart failure and reduced LVEF who were recently hospitalized. Patients were enrolled between August 2013 and March 2015 at 24 US sites. The GLP-1 agonist liraglutide (n = 154) or placebo (n = 146) via a daily subcutaneous injection; study drug was advanced to a dosage of 1.8 mg/d during the first 30 days as tolerated and continued for 180 days. The primary end point was a global rank score in which all patients, regardless of treatment assignment, were ranked across 3 hierarchical tiers: time to death, time to rehospitalization for heart failure, and time-averaged proportional change in N-terminal pro-B-type natriuretic peptide level from baseline to 180 days. Higher values indicate better health (stability). Exploratory secondary outcomes included primary end point components, cardiac structure and function, 6-minute walk distance, quality of life, and combined events. Among the 300 patients who were randomized (median age, 61 years [interquartile range {IQR}, 52-68 years]; 64 [21%] women; 178 [59%] with type 2 diabetes; median LVEF of 25% [IQR, 19%-33%]; median N-terminal pro-B-type natriuretic peptide level of 2049 pg/mL [IQR, 1054-4235 pg/mL]), 271 completed the study. Compared with placebo, liraglutide had no significant effect on the primary end point (mean rank of 146 for the liraglutide group vs 156 for the placebo group, P = .31). There were no significant between-group differences in the number of

Clinical leadership in contemporary clinical practice: implications for nursing in Australia.

PubMed

Davidson, P M; Elliott, D; Daly, J

2006-04-01

Leadership in the clinical practice environment is important to ensure both optimal patient outcomes and successive generations of motivated and enthusiastic clinicians. The present paper seeks to define and describe clinical leadership and identify the facilitators and barriers to clinical leadership. We also describe strategies to develop clinical leaders in Australia. Key drivers to the development of nursing leaders are strategies that recognize and value clinical expertise. These include models of care that highlight the importance of the nursing role; evidence-based practice and measurement of clinical outcomes; strategies to empower clinicians and mechanisms to ensure participation in clinical decision-making. Significant barriers to clinical leadership are organizational structures that preclude nurses from clinical decision making; the national shortage of nurses; fiscal constraints; absence of well evaluated models of care and trends towards less skilled clinicians. Systematic, strategic initiatives are required to nurture and develop clinical leaders. These strategies need to be collegial collaborations between the academic and health care sectors in order to provide a united voice for advancing the nursing profession.

Recent Advances in Cigarette Ignition Propensity Research and Development

PubMed Central

O’Connor, Richard J.; Spalletta, Ron; Connolly, Gregory N.

2009-01-01

Major U.S. cigarette companies for decades conducted research and development regarding cigarette ignition propensity which has continued beyond fire safety standards for cigarettes that have recently been legislated. This paper describes recent scientific advances and technological development based on a comprehensive review of the physical, chemical, and engineering sciences, public health, and trade literature, U.S. and international patents, and research in the tobacco industry document libraries. Advancements since the first implementation of standards have made been in: a) understanding the key parameters involved in cigarette smoldering combustion and ignition of substrates; b) developing new cigarette and paper wrapper designs to reduce ignition propensity, including banded and non-banded cigarette paper approaches, c) assessing toxicology, and d) measuring performance. While the implications of manufacturers’ non-safety related aims are of concern, this research indicates possible alternative designs should experience with fire loss and existing technologies on the market suggest need for improvement. PMID:20495669

Conceptualisation of the characteristics of advanced practitioners in the medical radiation professions

PubMed Central

Smith, Tony; Harris, Jillian; Woznitza, Nick; Maresse, Sharon; Sale, Charlotte

2015-01-01

Professions grapple with defining advanced practice and the characteristics of advanced practitioners. In nursing and allied health, advanced practice has been defined as ‘a state of professional maturity in which the individual demonstrates a level of integrated knowledge, skill and competence that challenges the accepted boundaries of practice and pioneers new developments in health care’. Evolution of advanced practice in Australia has been slower than in the United Kingdom, mainly due to differences in demography, the health system and industrial relations. This article describes a conceptual model of advanced practitioner characteristics in the medical radiation professions, taking into account experiences in other countries and professions. Using the CanMEDS framework, the model includes foundation characteristics of communication, collaboration and professionalism, which are fundamental to advanced clinical practice. Gateway characteristics are: clinical expertise, with high level competency in a particular area of clinical practice; scholarship and teaching, including a masters qualification and knowledge dissemination through educating others; and evidence-based practice, with judgements made on the basis of research findings, including research by the advanced practitioner. The pinnacle of advanced practice is clinical leadership, where the practitioner has a central role in the health care team, with the capacity to influence decision making and advocate for others, including patients. The proposed conceptual model is robust yet adaptable in defining generic characteristics of advanced practitioners, no matter their clinical specialty. The advanced practice roles that evolve to meet future health service demand must focus on the needs of patients, local populations and communities. PMID:26451243

Conceptualisation of the characteristics of advanced practitioners in the medical radiation professions.

PubMed

Smith, Tony; Harris, Jillian; Woznitza, Nick; Maresse, Sharon; Sale, Charlotte

2015-09-01

Professions grapple with defining advanced practice and the characteristics of advanced practitioners. In nursing and allied health, advanced practice has been defined as 'a state of professional maturity in which the individual demonstrates a level of integrated knowledge, skill and competence that challenges the accepted boundaries of practice and pioneers new developments in health care'. Evolution of advanced practice in Australia has been slower than in the United Kingdom, mainly due to differences in demography, the health system and industrial relations. This article describes a conceptual model of advanced practitioner characteristics in the medical radiation professions, taking into account experiences in other countries and professions. Using the CanMEDS framework, the model includes foundation characteristics of communication, collaboration and professionalism, which are fundamental to advanced clinical practice. Gateway characteristics are: clinical expertise, with high level competency in a particular area of clinical practice; scholarship and teaching, including a masters qualification and knowledge dissemination through educating others; and evidence-based practice, with judgements made on the basis of research findings, including research by the advanced practitioner. The pinnacle of advanced practice is clinical leadership, where the practitioner has a central role in the health care team, with the capacity to influence decision making and advocate for others, including patients. The proposed conceptual model is robust yet adaptable in defining generic characteristics of advanced practitioners, no matter their clinical specialty. The advanced practice roles that evolve to meet future health service demand must focus on the needs of patients, local populations and communities.

Conceptualisation of the characteristics of advanced practitioners in the medical radiation professions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Tony; Harris, Jillian; Woznitza, Nick

Professions grapple with defining advanced practice and the characteristics of advanced practitioners. In nursing and allied health, advanced practice has been defined as ‘a state of professional maturity in which the individual demonstrates a level of integrated knowledge, skill and competence that challenges the accepted boundaries of practice and pioneers new developments in health care’. Evolution of advanced practice in Australia has been slower than in the United Kingdom, mainly due to differences in demography, the health system and industrial relations. This article describes a conceptual model of advanced practitioner characteristics in the medical radiation professions, taking into account experiencesmore » in other countries and professions. Using the CanMEDS framework, the model includes foundation characteristics of communication, collaboration and professionalism, which are fundamental to advanced clinical practice. Gateway characteristics are: clinical expertise, with high level competency in a particular area of clinical practice; scholarship and teaching, including a masters qualification and knowledge dissemination through educating others; and evidence-based practice, with judgements made on the basis of research findings, including research by the advanced practitioner. The pinnacle of advanced practice is clinical leadership, where the practitioner has a central role in the health care team, with the capacity to influence decision making and advocate for others, including patients. The proposed conceptual model is robust yet adaptable in defining generic characteristics of advanced practitioners, no matter their clinical specialty. The advanced practice roles that evolve to meet future health service demand must focus on the needs of patients, local populations and communities.« less

Advancing adolescent maternal development: a grounded theory.

PubMed

Atkinson, Leah D; Peden-McAlpine, Cynthia J

2014-01-01

This paper reports a substantive grounded theory called the theory of Advancing Adolescent Maternal Development. A grounded theory approach was used. Thirty public health nurses working with adolescent clients in a state public health nurse home visiting program volunteered to participate in this study. The basic social psychological problem that emerged from the data was incomplete and at risk adolescent maternal development. Social support and public health nursing interventions are central in the problem resolution process which occurs in stages. Study results can be used to inform the nursing care of pregnant and parenting adolescents. © 2014.

Advanced Environmental Barrier Coatings Development for Si-Based Ceramics

NASA Technical Reports Server (NTRS)

Zhu, Dong-Ming; Choi, R. Sung; Robinson, Raymond C.; Lee, Kang N.; Bhatt, Ramakrishna T.; Miller, Robert A.

2005-01-01

Advanced environmental barrier coating concepts based on multi-component HfO2 (ZrO2) and modified mullite systems are developed for monolithic Si3N4 and SiC/SiC ceramic matrix composite (CMC) applications. Comprehensive testing approaches were established using the water vapor cyclic furnace, high pressure burner rig and laser heat flux steam rig to evaluate the coating water vapor stability, cyclic durability, radiation and erosion resistance under simulated engine environments. Test results demonstrated the feasibility and durability of the environmental barrier coating systems for 2700 to 3000 F monolithic Si3N4 and SiC/SiC CMC component applications. The high-temperature-capable environmental barrier coating systems are being further developed and optimized in collaboration with engine companies for advanced turbine engine applications.

The TPS Advanced Development Project for CEV

NASA Technical Reports Server (NTRS)

Reuther, James; Wercinski, Paul; Venkatapathy, Ethiraj; Ellerby, Don; Raiche, George; Bowman, Lynn; Jones, Craig; Kowal, John

2006-01-01

The CEV TPS Advanced Development Project (ADP) is a NASA in-house activity for providing two heatshield preliminary designs (a Lunar direct return as well as a LEO only return) for the CEV, including the TPS, the carrier structure, the interfaces and the attachments. The project s primary objective is the development of a single heatshield preliminary design that meets both Lunar direct return and LEO return requirements. The effort to develop the Lunar direct return capable heatshield is considered a high risk item for the NASA CEV development effort due to the low TRL (approx. 4) of the candidate TPS materials. By initiating the TPS ADP early in the development cycle, the intent is to use materials analysis and testing in combination with manufacturing demonstrations to reduce the programmatic risk of using advanced TPS technologies in the critical path for CEV. Due to the technical and schedule risks associated a Lunar return heatshield, the ADP will pursue a parallel path design approach, whereby a back-up TPS/heatshield design that only meets LEO return requirements is also developed. The TPS materials and carrier structure design concept selections will be based on testing, analysis, design and evaluation of scalability and manufacturing performed under the ADP. At the TPS PDR, the preferred programmatic strategy is to transfer the continued (detailed) design, development, testing and evaluation (DDT&E) of both the Lunar direct and LEO return designs to a government/prime contractor coordinated sub-system design team. The CEV prime contractor would have responsibility for the continued heatshield sub-system development. Continued government participation would include analysis, testing and evaluation as well as decision authority at TPS Final System Decision (FSD) (choosing between the primary and back-up heatshields) occurring between TPS PDR and TPS Critical Design Review (CDR). After TPS FSD the prime CEV contractor will complete the detailed design

Mobility disorders and pain, interrelations that need new research concepts and advanced clinical commitments