Research design considerations for single-dose analgesic clinical trials in acute pain

DEFF Research Database (Denmark)

Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C

2016-01-01

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials......, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay...... sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable...

Ethical, Legal, and Clinical Considerations when Disclosing a High-Risk Syndrome for Psychosis.

Science.gov (United States)

Mittal, Vijay A; Dean, Derek J; Mittal, Jyoti; Saks, Elyn R

2015-10-01

There are complex considerations when planning to disclose an attenuated psychosis syndrome (APS) diagnosis. In this review, we evaluate ethical, legal, and clinical perspectives as well as caveats related to full, non- and partial disclosure strategies, discuss societal implications, and provide clinical suggestions. Each of the disclosure strategies is associated with benefits as well as costs/considerations. Full disclosure promotes autonomy, allows for the clearest psychoeducation about additional risk factors, helps to clarify and/or correct previous diagnoses/treatments, facilitates early intervention and bolsters communication between providers but there are important considerations involving heritability, comorbidity, culture, and stigma. Non-disclosure advances nonmaleficence by limiting stigma and stress (which may inadvertently exacerbate the condition), and confusion (related to the rapidly evolving diagnosis) in a sensitive developmental period but is complicated by varying patient preferences and the possibility that, as new treatments without adverse effects become available, the risk with false positives no longer justifies the accompanying loss of autonomy. Partial disclosure balances ethical considerations by focusing on symptoms instead of labels, but evidence that laypersons may interpret this information as a pseudo-diagnosis and that symptoms alone also contribute to stigma limits the efficacy of this approach. In addition, there are notable societal considerations relating to disclosure involving conservatorship, the reach of insurance companies, and discrimination. We advocate a hybrid approach to disclosure and recommend future research aimed at understanding the effects of stigma on clinical course and a renewed focus on those help-seeking cases that do not transition but remain clinically relevant. © 2015 John Wiley & Sons Ltd.

Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines.

Science.gov (United States)

Vannice, Kirsten S; Wilder-Smith, Annelies; Barrett, Alan D T; Carrijo, Kalinka; Cavaleri, Marco; de Silva, Aravinda; Durbin, Anna P; Endy, Tim; Harris, Eva; Innis, Bruce L; Katzelnick, Leah C; Smith, Peter G; Sun, Wellington; Thomas, Stephen J; Hombach, Joachim

2018-03-07

Licensing and decisions on public health use of a vaccine rely on a robust clinical development program that permits a risk-benefit assessment of the product in the target population. Studies undertaken early in clinical development, as well as well-designed pivotal trials, allow for this robust characterization. In 2012, WHO published guidelines on the quality, safety and efficacy of live attenuated dengue tetravalent vaccines. Subsequently, efficacy and longer-term follow-up data have become available from two Phase 3 trials of a dengue vaccine, conducted in parallel, and the vaccine was licensed in December 2015. The findings and interpretation of the results from these trials released both before and after licensure have highlighted key complexities for tetravalent dengue vaccines, including concerns vaccination could increase the incidence of dengue disease in certain subpopulations. This report summarizes clinical and regulatory points for consideration that may guide vaccine developers on some aspects of trial design and facilitate regulatory review to enable broader public health recommendations for second-generation dengue vaccines. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Sustainable Product Strategy in Apparel Industry with Consumer Behavior Consideration

OpenAIRE

Liu Yang; Shaozeng Dong

2017-01-01

The article attempts to analyze sustainable product strategy in apparel industry specifically addressing a firm that is considering launching a sustainable product partly made from recycled materials. There are two types of consumers under consideration, environmentally conscious and regular consumers, as they have different perceived values for the sustainable products. The article provides an analytical model aimed to identify conditions under which a firm could benefit from adopting sustai...

Quality and clinical supply considerations of Paediatric Investigation Plans for IV preparations-A case study with the FP7 CloSed project.

Science.gov (United States)

Hanning, Sara M; Orlu Gul, Mine; Winslade, Jackie; Baarslag, Manuel A; Neubert, Antje; Tuleu, Catherine

2016-09-25

A Paediatric Investigation Plan (PIP) is a development plan that aims to ensure that sufficient data are obtained through studies in paediatrics to support the generation of marketing authorisation of medicines for children. This paper highlights some practical considerations and challenges with respect to PIP submissions and paediatric clinical trials during the pharmaceutical development phase, using the FP7-funded Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit (CloSed) project as a case study. Examples discussed include challenges and considerations regarding formulation development, blinding and randomisation, product labelling and shipment and clinical trial requirements versus requirements for marketing authorisation. A significant quantity of information is required for PIP submissions and it is hoped that future applicants may benefit from an insight into some critical considerations and challenges faced in the CloSed project. Copyright © 2016 Elsevier B.V. All rights reserved.

Considerations for emotion-aware consumer products.

Science.gov (United States)

van den Broek, Egon L; Westerink, Joyce H D M

2009-11-01

Emotion-aware consumer products require reliable, short-term emotion assessment (i.e., unobtrusive, robust, and lacking calibration). To explore the feasibility of this, an experiment was conducted where the galvanic skin response (GSR) and three electromyography (EMG) signals (frontalis, corrugator supercilii, and zygomaticus major) were recorded on 24 participants who watched eight 2-min emotion inducing film fragments. The unfiltered psychophysiological signals were processed and six statistical parameters (i.e., mean, absolute deviation, standard deviation, variance, skewness, and kurtosis) were derived for each 10-s interval of the film fragment. For each physiological signal, skewness and kurtosis discriminated among affective states, accompanied by other parameters, depending on the signal. The skewness parameter also showed to indicate mixed emotions. Moreover, a mapping of events in the fragments on the signals showed the importance of short-term emotion assessment. Hence, this research identified generic features, denoted important considerations, and illustrated the feasibility of emotion-aware consumer products.

Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

Science.gov (United States)

Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A

2015-07-01

Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

DESIGN CONSIDERATIONS UPON PRODUCT END-OF-LIFE OPTIONS

Directory of Open Access Journals (Sweden)

BARSAN Lucian

2016-11-01

Full Text Available The paper presents some considerations about the necessity of evaluating the environmental impact of a product during its entire life. The present situation (economic, social and ecologic imposes solutions to reduce this impact as a result of an analysis performed during all stages of the life cycle. This paper focuses on design solutions with consequences in the last stage, the end-of-life. Reusing products, with, or without remanufacturing and recycling the materials from products that cannot be reused represent some options analysed in this paper. The end-of-life options should be known even from the beginning of the design process and should be included as design objectives or, at least as constrictions. Considering them as human needs would naturally include them in the requirements list.

[Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products].

Science.gov (United States)

Lehmann, Jörg; Schulz, Ronny M; Sanzenbacher, Ralf

2015-11-01

For the development of medicinal products animal models are still indispensable to demonstrate efficacy and safety prior to first use in humans. Advanced therapy medicinal products (ATMP), which include cell-based medicinal products (CBMP), differ in their pharmacology and toxicology compared to conventional pharmaceuticals, and thus, require an adapted regime for non-clinical development. Developers are, therefore, challenged to develop particular individual concepts and to reconcile these with regulatory agencies. Guidelines issued by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other sources can provide direction.The published approaches for non-clinical testing of efficacy document that homologous animal models where the therapeutic effect is investigated in a disease-relevant animal model utilizing cells derived from the same species are commonly used. The challenge is that the selected model should reflect the human disease in all critical features and that the cells should be comparable to the investigated human medicinal product in terms of quality and biological activity. This is not achievable in all cases. In these cases, alternative methods may provide supplemental information. To demonstrate the scientific proof-of-concept (PoC), small animal models such as mice or rats are preferred. During the subsequent product development phase, large animal models (i.e. sheep, minipigs, dogs) must be considered, as they may better reflect the anatomical or physiological situation in humans. In addition to efficacy, those models may also be suitable to prove some safety aspects of ATMP (e.g. regarding dose finding, local tolerance, or undesired interactions and effects of the administered cells in the target tissue). In contrast, for evaluation of the two prominent endpoints for characterizing the safety of ATMP (i.e. biodistribution, tumorigenicity) heterologous small animal models, especially immunodeficient mouse strains

Clinical and practical considerations in the pharmacologic management of narcolepsy.

Science.gov (United States)

Thorpy, Michael J; Dauvilliers, Yves

2015-01-01

Despite published treatment recommendations and the availability of approved and off-label pharmacologic therapies for narcolepsy, the clinical management of this incurable, chronic neurologic disorder remains challenging. While treatment is generally symptomatically driven, decisions regarding which drug(s) to use need to take into account a variety of factors that may affect adherence, efficacy, and tolerability. Type 1 narcolepsy (predominantly excessive daytime sleepiness with cataplexy) or type 2 narcolepsy (excessive daytime sleepiness without cataplexy) may drive treatment decisions, with consideration given either to a single drug that targets multiple symptoms or to multiple drugs that each treat a specific symptom. Other drug-related characteristics that affect drug choice are dosing regimens, tolerability, and potential drug-drug interactions. Additionally, the patient should be an active participant in treatment decisions, and the main symptomatic complaints, treatment goals, psychosocial setting, and use of lifestyle substances (ie, alcohol, nicotine, caffeine, and cannabis) need to be discussed with respect to treatment decisions. Although there is a lack of narcolepsy-specific instruments for monitoring therapeutic effects, clinically relevant subjective and objective measures of daytime sleepiness (eg, Epworth Sleepiness Scale and Maintenance of Wakefulness Test) can be used to provide guidance on whether treatment goals are being met. These considerations are discussed with the objective of providing clinically relevant recommendations for making treatment decisions that can enhance the effective management of patients with narcolepsy. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

Cost consideration in the clinical guidance documents of physician specialty societies in the United States.

Science.gov (United States)

Schwartz, Jennifer A T; Pearson, Steven D

2013-06-24

Despite increasing concerns regarding the cost of health care, the consideration of costs in the development of clinical guidance documents by physician specialty societies has received little analysis. To evaluate the approach to consideration of cost in publicly available clinical guidance documents and methodological statements produced between 2008 and 2012 by the 30 largest US physician specialty societies. Qualitative document review. Whether costs are considered in clinical guidance development, mechanism of cost consideration, and the way that cost issues were used in support of specific clinical practice recommendations. Methodological statements for clinical guidance documents indicated that 17 of 30 physician societies (57%) explicitly integrated costs, 4 (13%) implicitly considered costs, 3 (10%) intentionally excluded costs, and 6 (20%) made no mention. Of the 17 societies that explicitly integrated costs, 9 (53%) consistently used a formal system in which the strength of recommendation was influenced in part by costs, whereas 8 (47%) were inconsistent in their approach or failed to mention the exact mechanism for considering costs. Among the 138 specific recommendations in these guidance documents that included cost as part of the rationale, the most common form of recommendation (50 [36%]) encouraged the use of a specific medical service because of equal effectiveness and lower cost. Slightly more than half of the largest US physician societies explicitly consider costs in developing their clinical guidance documents; among these, approximately half use an explicit mechanism for integrating costs into the strength of recommendations. Many societies remain vague in their approach. Physician specialty societies should demonstrate greater transparency and rigor in their approach to cost consideration in documents meant to influence care decisions.

Considerations for higher efficiency and productivity in research activities.

Science.gov (United States)

Forero, Diego A; Moore, Jason H

2016-01-01

There are several factors that are known to affect research productivity; some of them imply the need for large financial investments and others are related to work styles. There are some articles that provide suggestions for early career scientists (PhD students and postdocs) but few publications are oriented to professors about scientific leadership. As academic mentoring might be useful at all levels of experience, in this note we suggest several key considerations for higher efficiency and productivity in academic and research activities. More research is needed into the main work style features that differentiate highly productive scientists and research groups, as some of them could be innate and others could be transferable. As funding agencies, universities and research centers invest large amounts of money in order to have a better scientific productivity, a deeper understanding of these factors will be of high academic and societal impact.

Intimacy and Sexuality in Institutionalized Dementia Care: Clinical-Ethical Considerations.

Science.gov (United States)

Mahieu, Lieslot; Anckaert, Luc; Gastmans, Chris

2017-03-01

Intimacy and sexuality expressed by nursing home residents with dementia remains an ethically sensitive issue for care facilities, nursing staff and family members. Dealing with residents' sexual longings and behaviour is extremely difficult, putting a burden on the caregivers as well as on the residents themselves and their relatives. The parties in question often do not know how to react when residents express themselves sexually. The overall aim of this article is to provide a number of clinical-ethical considerations addressing the following question: 'How can expressions of intimacy and sexuality by residents with dementia be dealt with in an ethically responsible way?' The considerations formulated are based on two cornerstones: (1) the current literature on older peoples' experiences regarding intimacy and sexuality after the onset of dementia, and (2) an anthropological-ethical framework addressing four fundamental pillars of human existence namely the decentred self, human embodiment, being-in-the-world and being-with-others. The resulting considerations are oriented toward the individual sphere, the partnership sphere, and the institutional sphere. The continuous interaction between these spheres leads to orientations that both empower the residents in question and respect the complex network of relationships that surrounds them.

14 CFR 1263.105 - Considerations in determining whether production or disclosure should be made.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Considerations in determining whether... § 1263.105 Considerations in determining whether production or disclosure should be made. The General...) Whether disclosure might improperly reveal trade secrets, or commercial or financial information that is...

Ethical considerations in export of hazardous products to institutionally vulnerable countries

DEFF Research Database (Denmark)

Jørgensen, Michael Søgaard; Milanez, Bruno

2018-01-01

company in vulnerable countries with a special focus on Brazil. The identified ethical considerations are related to: The transnational company’s interpretation of its regulatory and ethical obligations for development and use of its hazardous products in vulnerable countries, path dependency and path...

Assessment of tobacco heating product THP1.0. Part 9: The placement of a range of next-generation products on an emissions continuum relative to cigarettes via pre-clinical assessment studies.

Science.gov (United States)

Murphy, James; Liu, Chuan; McAdam, Kevin; Gaҫa, Marianna; Prasad, Krishna; Camacho, Oscar; McAughey, John; Proctor, Christopher

2018-03-01

This series of nine papers described the operation and pre-clinical assessment of a tobacco heating product THP1.0. This last paper contextualises the pre-clinical assessment data on THP1.0 with data from other next generation products relative to cigarette smoke. The tobacco and nicotine risk continuum is a concept that ranks products according to their potential harm, with cigarettes at the highest risk extreme and Nicotine Replacement Therapy at the least risky extreme. Data generated in pre-clinical studies on THP1.0 and a range of Next Generation Products (NGPs) may provide some initial indication of potential ranking of these products, although importantly, data from such studies are limited and cannot take into consideration several important aspects for risk such as long term product use patterns. In each of the studies, the responses to the emissions from THP1.0 were substantially reduced relative to cigarette smoke. Additionally, responses from THP1.0 were very similar to those from the other NGP emissions. A comparison of the results clearly showed the emissions from all the NGPs were considerably lower than those from cigarettes and all in around the same emissions level. These results show that THP1.0 could have the potential to be a reduced risk product compared to cigarettes, though further studies assessing the exposure, individual and population risk reduction profile would be required to substantiate this potential. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Counselors' Role in Preventing Abuse of Older Adults: Clinical, Ethical, and Legal Considerations

Science.gov (United States)

Forman, Julia M.; McBride, Rebecca G.

2010-01-01

Mistreatment of older adults is commonplace. These individuals are subjected to abuse, financial exploitation, and neglect. The authors present an overview of the literature concerning mistreatment, with an emphasis on clinical, ethical, and legal considerations. Methods are proposed for prevention, including counselor education, advocacy, and…

Safety considerations for continuous hydrogen production test apparatus with capacity of 50 N-litter hydrogen per hour

International Nuclear Information System (INIS)

Onuki, Kaoru; Akino, Norio; Shimizu, Saburo; Nakajima, Hayato; Higashi, Shunichi; Kubo, Shinji

2001-03-01

Since the thermochemical hydrogen production Iodine-Sulfur process decomposes water into hydrogen and oxygen using toxic chemicals such as sulfuric acid, iodine and hydriodic acid, safety considerations are very important in its research and development. Therefore, before construction of continuous hydrogen production test apparatus with capacity of 50 N-litter hydrogen per hour, comprehensive safety considerations were carried out to examine the design and construction works of the test apparatus, and the experimental plans using the apparatus. Emphasis was given on the safety considerations on prevention of breakage of glasswares and presumable abnormalities, accidents and their countermeasures. This report summarizes the results of the considerations. (author)

Biosimilars 101: considerations for U.S. oncologists in clinical practice

International Nuclear Information System (INIS)

Camacho, Luis H; Frost, Craig P; Abella, Esteban; Morrow, Phuong K; Whittaker, Sadie

2014-01-01

Biosimilars of biologics used for cancer treatment and supportive care are expected to enter the U.S. market soon. Biosimilars will be highly similar to their reference products, but unlike generic drugs, not identical. Differences between a biosimilar and its reference product may arise because of the complexity of biologics, and differences in the cell lines and processes used during manufacturing. Biosimilars will be approved in the United States through a regulatory pathway based on comparative analytical and clinical studies for their characterization and demonstration of no clinically meaningful differences from their reference products. Unlike generics, initial approval may not include interchangeability, as additional evidence may be required before a biosimilar could be approved as interchangeable with its reference product; interchangeable designation could allow pharmacy-level substitution without prescriber intervention. In some cases, the U.S. Food and Drug Administration (FDA) may extrapolate an indication that has not been formally investigated for the biosimilar but that is approved for the reference product. Robust safety monitoring of all biologics is important to track and accurately attribute adverse events, particularly because their inherent complexity and manufacturing differences make them susceptible to structural changes that can affect safety (e.g., immunogenicity). Accuracy of postapproval safety reports will partly depend on the biosimilar naming approach. Potential cost savings should be evaluated in the context of differences in manufacturers' patient-assistance programs, copayments, and institutional costs. A manufacturer's ability to ensure reliable supply of high-quality biosimilars should also be considered. Broad understanding of these issues is critical for oncologists preparing for their use in clinical practice

TU-A-201-02: Treatment Site-Specific Considerations for Clinical IGRT

Energy Technology Data Exchange (ETDEWEB)

Wijesooriya, K. [University of Virginia Health Systems (United States)

2016-06-15

Recent years have seen a widespread proliferation of available in-room image guidance systems for radiation therapy target localization with many centers having multiple in-room options. In this session, available imaging systems for in-room IGRT will be reviewed highlighting the main differences in workflow efficiency, targeting accuracy and image quality as it relates to target visualization. Decision-making strategies for integrating these tools into clinical image guidance protocols that are tailored to specific disease sites like H&N, lung, pelvis, and spine SBRT will be discussed. Learning Objectives: Major system characteristics of a wide range of available in-room imaging systems for IGRT. Advantages / disadvantages of different systems for site-specific IGRT considerations. Concepts of targeting accuracy and time efficiency in designing clinical imaging protocols.

PRODUCTION CONSIDERATIONS FOR THE CLASSICAL PET NUCLIDES.

Energy Technology Data Exchange (ETDEWEB)

FINN,R.; SCHLYER,D.

2001-06-25

Nuclear Medicine is the specialty of medical imaging, which utilizes a variety of radionuclides incorporated into specific compounds for diagnostic imaging and therapeutic applications. During recent years, research efforts associated with this discipline have concentrated on the decay characteristics of particular radionuclides and the design of unique radiolabeled tracers necessary to achieve time-dependent molecular images. The specialty is expanding with specific Positron emission tomography (PET) and SPECT radiopharmaceuticals allowing for an extension from functional process imaging in tissue to pathologic processes and nuclide directed treatments. PET is an example of a technique that has been shown to yield the physiologic information necessary for clinical oncology diagnoses based upon altered tissue metabolism. Most PET drugs are currently produced using a cyclotron at locations that are in close proximity to the hospital or academic center at which the radiopharmaceutical will be administered. In November 1997, a law was enacted called the Food and Drug Administration Modernization Act of 1997 which directed the Food and Drug Administration (FDA) to establish appropriate procedures for the approval of PET drugs in accordance with section 505 of the Federal Food, Drug, and Cosmetic Act and to establish current good manufacturing practice requirements for such drugs. At this time the FDA is considering adopting special approval procedures and cGMP requirements for PET drugs. The evolution of PET radiopharmaceuticals has introduced a new class of ''drugs'' requiring production facilities and product formulations that must be closely aligned with the scheduled clinical utilization. The production of the radionuclide in the appropriate synthetic form is but one critical component in the manufacture of the finished radiopharmaceutical.

PRODUCTION CONSIDERATIONS FOR THE CLASSICAL PET NUCLIDES

International Nuclear Information System (INIS)

FINN, R.; SCHLYER, D.

2001-01-01

Nuclear Medicine is the specialty of medical imaging, which utilizes a variety of radionuclides incorporated into specific compounds for diagnostic imaging and therapeutic applications. During recent years, research efforts associated with this discipline have concentrated on the decay characteristics of particular radionuclides and the design of unique radiolabeled tracers necessary to achieve time-dependent molecular images. The specialty is expanding with specific Positron emission tomography (PET) and SPECT radiopharmaceuticals allowing for an extension from functional process imaging in tissue to pathologic processes and nuclide directed treatments. PET is an example of a technique that has been shown to yield the physiologic information necessary for clinical oncology diagnoses based upon altered tissue metabolism. Most PET drugs are currently produced using a cyclotron at locations that are in close proximity to the hospital or academic center at which the radiopharmaceutical will be administered. In November 1997, a law was enacted called the Food and Drug Administration Modernization Act of 1997 which directed the Food and Drug Administration (FDA) to establish appropriate procedures for the approval of PET drugs in accordance with section 505 of the Federal Food, Drug, and Cosmetic Act and to establish current good manufacturing practice requirements for such drugs. At this time the FDA is considering adopting special approval procedures and cGMP requirements for PET drugs. The evolution of PET radiopharmaceuticals has introduced a new class of ''drugs'' requiring production facilities and product formulations that must be closely aligned with the scheduled clinical utilization. The production of the radionuclide in the appropriate synthetic form is but one critical component in the manufacture of the finished radiopharmaceutical

Clinical implementation of x-ray phase-contrast imaging: Theoretical foundations and design considerations

International Nuclear Information System (INIS)

Wu Xizeng; Liu Hong

2003-01-01

Theoretical foundation and design considerations of a clinical feasible x-ray phase contrast imaging technique were presented in this paper. Different from the analysis of imaging phase object with weak absorption in literature, we proposed a new formalism for in-line phase-contrast imaging to analyze the effects of four clinically important factors on the phase contrast. These are the body parts attenuation, the spatial coherence of spherical waves from a finite-size focal spot, and polychromatic x-ray and radiation doses to patients for clinical applications. The theory presented in this paper can be applied widely in diagnostic x-ray imaging procedures. As an example, computer simulations were conducted and optimal design parameters were derived for clinical mammography. The results of phantom experiments were also presented which validated the theoretical analysis and computer simulations

Clinical considerations in restorative dentistry - A narrative review

Directory of Open Access Journals (Sweden)

Ashwini Tumkur Shivakumar

2015-01-01

Full Text Available The relationship between periodontal health and the restoration of teeth is intimate and inseparable. Human teeth are designed in such a way that the individual tooth contributes significantly to their own support as well as collectively the teeth in the arch. Decay on the proximal surfaces occurs mainly due to the faulty interrelationship between the contact area, marginal ridge, the embrasures and the gingiva. An adequate understanding of the relationship between periodontal tissues and restorative dentistry is paramount to ensure an adequate form, function, aesthetics and comfort of the dentition. For long-term survival of restoration, both functionally and esthetically, certain biological considerations are very critical to preserve the health of the periodontium and thus must be given due importance in clinical practice. While most clinicians are aware of this important relationship, uncertainly remains regarding specific concept such as biologic width and its maintainces.

Scholarly productivity for nursing clinical track faculty.

Science.gov (United States)

Tschannen, Dana; Anderson, Christine; Strobbe, Stephen; Bay, Esther; Bigelow, April; Dahlem, Chin Hwa Gina Y; Gosselin, Ann K; Pollard, Jennifer; Seng, Julia S

2014-01-01

Recent years have yielded substantial advancement by clinical track faculty in cohort expansion and collective contributions to the discipline of nursing. As a result, standards for progression and promotion for clinical faculty need to be more fully developed, articulated, and disseminated. Our school formed a task force to examine benchmarks for the progression and promotion of clinical faculty across schools of nursing, with the goal of guiding faculty, reviewers, and decision makers about what constitutes excellence in scholarly productivity. Results from analyses of curriculum vitae of clinical professors or associate professors at six universities with high research activity revealed a variety of productivity among clinical track members, which included notable diversity in the types of scholarly products. Findings from this project help quantify types of scholarship for clinical faculty at the time of promotion. This work provides a springboard for greater understanding of the contributions of clinical track faculty to nursing practice. Copyright © 2014 Elsevier Inc. All rights reserved.

Considerations for automated machine learning in clinical metabolic profiling: Altered homocysteine plasma concentration associated with metformin exposure.

Science.gov (United States)

Orlenko, Alena; Moore, Jason H; Orzechowski, Patryk; Olson, Randal S; Cairns, Junmei; Caraballo, Pedro J; Weinshilboum, Richard M; Wang, Liewei; Breitenstein, Matthew K

2018-01-01

With the maturation of metabolomics science and proliferation of biobanks, clinical metabolic profiling is an increasingly opportunistic frontier for advancing translational clinical research. Automated Machine Learning (AutoML) approaches provide exciting opportunity to guide feature selection in agnostic metabolic profiling endeavors, where potentially thousands of independent data points must be evaluated. In previous research, AutoML using high-dimensional data of varying types has been demonstrably robust, outperforming traditional approaches. However, considerations for application in clinical metabolic profiling remain to be evaluated. Particularly, regarding the robustness of AutoML to identify and adjust for common clinical confounders. In this study, we present a focused case study regarding AutoML considerations for using the Tree-Based Optimization Tool (TPOT) in metabolic profiling of exposure to metformin in a biobank cohort. First, we propose a tandem rank-accuracy measure to guide agnostic feature selection and corresponding threshold determination in clinical metabolic profiling endeavors. Second, while AutoML, using default parameters, demonstrated potential to lack sensitivity to low-effect confounding clinical covariates, we demonstrated residual training and adjustment of metabolite features as an easily applicable approach to ensure AutoML adjustment for potential confounding characteristics. Finally, we present increased homocysteine with long-term exposure to metformin as a potentially novel, non-replicated metabolite association suggested by TPOT; an association not identified in parallel clinical metabolic profiling endeavors. While warranting independent replication, our tandem rank-accuracy measure suggests homocysteine to be the metabolite feature with largest effect, and corresponding priority for further translational clinical research. Residual training and adjustment for a potential confounding effect by BMI only slightly modified

Ethical considerations in clinical research on herbal medicine for prevention of cardiovascular disease in the ageing.

Science.gov (United States)

Koonrungsesomboon, Nut; Karbwang, Juntra

2016-10-15

Cardiovascular disease (CVD) in the ageing is a major public health problem worldwide. The nature of most CVD is subclinical with pathological processes that can span over years. Use of preventive measures could be an appropriate approach to prevailing over CVD in the ageing, and herbal medicine is one of the promising preventive approaches and is currently of interest among medical societies. In the evidence-based era, herbal medicine is, however, often underestimated and approached with skepticism, mainly due to the paucity of scientific evidence. Properly designed clinical trials on herbal medicine for prevention of CVD in a geriatric population are thus of importance and of clinical value. To review ethical issues and discuss considerations when such research is proposed. Four ethical issues, including the scientific validity of research, risk-benefit assessments, subject selection and vulnerability, and informed consent, are structured and extensively discussed in this article. Ethical core considerations of prevention research of CVD on herbal medicine involve particular attention on the scientific validity of research, risk-benefit assessments, subject selection and vulnerability, and informed consent. These issues and considerations are keys, although they must be adapted to an individual research setting in which a clinical study is proposed. Copyright © 2015 Elsevier GmbH. All rights reserved.

MO-E-BRC-00: Online Adaptive Radiotherapy - Considerations for Practical Clinical Implementation

International Nuclear Information System (INIS)

2016-01-01

Online adaptive radiation therapy has the potential to ensure delivery of optimal treatment to the patient by accounting for anatomical and potentially functional changes that occur from one fraction to the next and over the course of treatment. While on-line adaptive RT (ART) has been a topic of many publications, discussions, and research, it has until very recently remained largely a concept and not a practical implementation. However, recent advances in on-table imaging, use of deformable image registration for contour generation and dose tracking, faster and more efficient plan optimization, as well as fast quality assurance method has enabled the implementation of ART in the clinic in the past couple of years. The introduction of these tools into routine clinical use requires many considerations and progressive knowledge to understand how processes that have historically taken hours/days to complete can now be done in less than 30 minutes. This session will discuss considerations to perform real time contouring, planning and patient specific QA, as well as a practical workflow and the required resources. Learning Objectives: To understand the difficulties, challenges and available technologies for online adaptive RT. To understand how to implement online adaptive therapy in a clinical environment and to understand the workflow and resources required. To understand the limitations and sources of uncertainty in the online adaptive process I have research funding from ViewRay Inc. and Philips Medical Systems.; R. Kashani, I have research funding from ViewRay Inc. and Philips Medical Systems.; X. Li, Research supported by Elekta Inc.

MO-E-BRC-00: Online Adaptive Radiotherapy - Considerations for Practical Clinical Implementation

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

Online adaptive radiation therapy has the potential to ensure delivery of optimal treatment to the patient by accounting for anatomical and potentially functional changes that occur from one fraction to the next and over the course of treatment. While on-line adaptive RT (ART) has been a topic of many publications, discussions, and research, it has until very recently remained largely a concept and not a practical implementation. However, recent advances in on-table imaging, use of deformable image registration for contour generation and dose tracking, faster and more efficient plan optimization, as well as fast quality assurance method has enabled the implementation of ART in the clinic in the past couple of years. The introduction of these tools into routine clinical use requires many considerations and progressive knowledge to understand how processes that have historically taken hours/days to complete can now be done in less than 30 minutes. This session will discuss considerations to perform real time contouring, planning and patient specific QA, as well as a practical workflow and the required resources. Learning Objectives: To understand the difficulties, challenges and available technologies for online adaptive RT. To understand how to implement online adaptive therapy in a clinical environment and to understand the workflow and resources required. To understand the limitations and sources of uncertainty in the online adaptive process I have research funding from ViewRay Inc. and Philips Medical Systems.; R. Kashani, I have research funding from ViewRay Inc. and Philips Medical Systems.; X. Li, Research supported by Elekta Inc.

Ethical considerations in clinical training, care and research in psychopharmacology.

Science.gov (United States)

Strous, Rael D

2011-04-01

Psychopharmacology is a powerful tool in psychiatry; however, it is one that demands responsibility in order to deal with the ethical complexities that accompany advances in the field. It is important that questions are asked and that ethical mindfulness and sensitivity are developed along with clinical skills. In order to cultivate and deepen ethical awareness and subsequently solve issues in optimal fashion, investment should be made in the development of an ethical decision-making process as well as in education in the ethics of psychopharmacology to trainees in the field at all stages of their educational development. A clear approach to identifying ethical problems, engaging various ethical concepts in considering solutions and then applying these principles in problem resolution is demanded. An openness in identifying and exploring issues has become crucial to the future development and maturation of psychopharmacologists, both research and clinical. Consideration must be given to the social implications of psychopharmacological practice, with the best interests of patients always paramount. From both a research and clinical perspective, psychopharmacology has to be practised with fairness, sensitivity and ethical relevance to all. While ethical issues related to psychopharmacological practice are varied and plentiful, this review focuses on advances in technology and biological sciences, personal integrity, special populations, and education and training.

Sustainable Product Strategy in Apparel Industry with Consumer Behavior Consideration

Directory of Open Access Journals (Sweden)

Liu Yang

2017-05-01

Full Text Available The article attempts to analyze sustainable product strategy in apparel industry specifically addressing a firm that is considering launching a sustainable product partly made from recycled materials. There are two types of consumers under consideration, environmentally conscious and regular consumers, as they have different perceived values for the sustainable products. The article provides an analytical model aimed to identify conditions under which a firm could benefit from adopting sustainable product strategy. The level of sustainability is determined by the trade-off between profitability and costs occurred and if more consumers value sustainable products, the firm will increase its sustainable level and get a higher profit. This is because of a combination effect of an increasing marginal profit and demand expansion. Moreover, the model has been further extended to address a situation where the firm could manage consumer segmentation. Depending on parameter settings, the firm may target different consumer segments and there is always a threshold of cost for managing consumer segments. When converting regular consumers to be environmentally conscious is not costly, the firm will convert all consumers to be environmentally conscious with great efforts; otherwise, the firm will convert part of consumers to be environmentally conscious.

Biofluid infrared spectro-diagnostics: pre-analytical considerations for clinical applications.

Science.gov (United States)

Lovergne, L; Bouzy, P; Untereiner, V; Garnotel, R; Baker, M J; Thiéfin, G; Sockalingum, G D

2016-06-23

Several proof-of-concept studies on the vibrational spectroscopy of biofluids have demonstrated that the methodology has promising potential as a clinical diagnostic tool. However, these studies also show that there is a lack of a standardised protocol in sample handling and preparation prior to spectroscopic analysis. One of the most important sources of analytical errors is the pre-analytical phase. For the technique to be translated into clinics, it is clear that a very strict protocol needs to be established for such biological samples. This study focuses on some of the aspects of the pre-analytical phase in the development of the high-throughput Fourier Transform Infrared (FTIR) spectroscopy of some of the most common biofluids such as serum, plasma and bile. Pre-analytical considerations that can impact either the samples (solvents, anti-coagulants, freeze-thaw cycles…) and/or spectroscopic analysis (sample preparation such as drying, deposit methods, volumes, substrates, operators dependence…) and consequently the quality and the reproducibility of spectral data will be discussed in this report.

Design consideration on hydrogen production demonstration plant of thermochemical IS process

International Nuclear Information System (INIS)

Iwatsuki, Jin; Noguchi, Hiroki; Terada, Atsuhiko; Kubo, Shinji; Sakaba, Nariaki; Onuki, Kaoru; Hino, Ryutaro

2009-03-01

Preliminary design study was carried out on the hydrogen production demonstration plant of thermochemical IS process. In the pilot test, hydrogen production will be examined under prototypical condition using an apparatus made of industrial materials, which is driven by the sensible heat of helium gas heated by an electric heater that simulates the High Temperature Engineering Test Reactor (HTTR). Tentative system condition was defined considering the HTTR specification and the experience on the construction and the operation of the mock-up test facility using methane reforming for hydrogen production. The process condition and the system flow diagram were discussed to meet the system condition. Based on the defined process condition, types of the main components were discussed taking the corrosion resistance of the structural materials into consideration. Applicable rules and regulations were also surveyed regarding the plant construction and operation. (author)

Myocardial Contrast Agents – Safety Considerations and Clinical Efficacy in Stress Echocardiography

Directory of Open Access Journals (Sweden)

Maier Anca

2016-11-01

Full Text Available Transthoracic echocardiographic examination is known to be a safe, non-invasive and reproducible method, used in every day clinical practice to obtain important information about cardiac structure and function. Unfortunately, a significant proportion of studies have highlighted the considerable technically difficultly in producing diagnostic images due to a poor acoustic window and more than 33% of patients undergoing stress echocardiography have suboptimal echocardiographic images. All these limitations have led to the use of contrast agents to improve the quality of standard ultrasound examination to provide a better delineation of left ventricle endocardial borders or to obtain information that cannot be achieved by using standard echocardiography, such as assessing myocardial microcirculation and therefore perfusion. This paper sought to review the clinical efficacy and safety of ultrasound contrast agents focusing on stress echocardiography.

Important considerations for designing and reporting epidemiologic and clinical studies in dental traumatology

DEFF Research Database (Denmark)

Andersson, Lars; Andreasen, Jens O

2011-01-01

The purpose of this article is to suggest important considerations for epidemiologic and clinical studies in the field of dental traumatology. The article is based on the authors' experiences from research in this field and editorial board work for the scientific journal Dental Traumatology....... Examples are given of issues where development is important. The importance of planning ahead of the study and consulting with experts in other fields is emphasized....

Surgical Procedures and Clinical Considerations for Impacted Canines: A Literature Review

Directory of Open Access Journals (Sweden)

Parviz Torkzaban

2016-09-01

Full Text Available Impaction of canine teeth is a clinical problem whose treatment usually requires an interdisciplinary approach. After the maxillary third molar, the maxillary canine is the second-most commonly impacted tooth, with an incidence of 1% - 2.5%. Maxillary canines are more common in females than males. This study reviews the surgical treatments and orthodontic considerations for impacted canines exposure reported in previous studies. The clinician should be aware of variations in the surgical management of labially and palatally impacted canines, as well as the most common methods of canine in orthodontic application, and the implications of canine extraction. The different factors that affect these decisions are discussed.

Important considerations for designing and reporting epidemiologic and clinical studies in dental traumatology.

Science.gov (United States)

Andersson, Lars; Andreasen, Jens O

2011-08-01

The purpose of this article is to suggest important considerations for epidemiologic and clinical studies in the field of dental traumatology. The article is based on the authors' experiences from research in this field and editorial board work for the scientific journal Dental Traumatology. Examples are given of issues where development is important. The importance of planning ahead of the study and consulting with experts in other fields is emphasized. © 2011 John Wiley & Sons A/S.

Projecting biodiversity and wood production in future forest landscapes: 15 key modeling considerations.

Science.gov (United States)

Felton, Adam; Ranius, Thomas; Roberge, Jean-Michel; Öhman, Karin; Lämås, Tomas; Hynynen, Jari; Juutinen, Artti; Mönkkönen, Mikko; Nilsson, Urban; Lundmark, Tomas; Nordin, Annika

2017-07-15

A variety of modeling approaches can be used to project the future development of forest systems, and help to assess the implications of different management alternatives for biodiversity and ecosystem services. This diversity of approaches does however present both an opportunity and an obstacle for those trying to decide which modeling technique to apply, and interpreting the management implications of model output. Furthermore, the breadth of issues relevant to addressing key questions related to forest ecology, conservation biology, silviculture, economics, requires insights stemming from a number of distinct scientific disciplines. As forest planners, conservation ecologists, ecological economists and silviculturalists, experienced with modeling trade-offs and synergies between biodiversity and wood biomass production, we identified fifteen key considerations relevant to assessing the pros and cons of alternative modeling approaches. Specifically we identified key considerations linked to study question formulation, modeling forest dynamics, forest processes, study landscapes, spatial and temporal aspects, and the key response metrics - biodiversity and wood biomass production, as well as dealing with trade-offs and uncertainties. We also provide illustrative examples from the modeling literature stemming from the key considerations assessed. We use our findings to reiterate the need for explicitly addressing and conveying the limitations and uncertainties of any modeling approach taken, and the need for interdisciplinary research efforts when addressing the conservation of biodiversity and sustainable use of environmental resources. Copyright © 2017 Elsevier Ltd. All rights reserved.

Circulating Tumor Cell Analysis: Technical and Statistical Considerations for Application to the Clinic

Directory of Open Access Journals (Sweden)

Alison L. Allan

2010-01-01

Full Text Available Solid cancers are a leading cause of death worldwide, primarily due to the failure of effective clinical detection and treatment of metastatic disease in distant sites. There is growing evidence that the presence of circulating tumor cells (CTCs in the blood of cancer patients may be an important indicator of the potential for metastatic disease and poor prognosis. Technological advances have now facilitated the enumeration and characterization of CTCs using methods such as PCR, flow cytometry, image-based immunologic approaches, immunomagnetic techniques, and microchip technology. However, the rare nature of these cells requires that very sensitive and robust detection/enumeration methods be developed and validated in order to implement CTC analysis for widespread use in the clinic. This review will focus on the important technical and statistical considerations that must be taken into account when designing and implementing CTC assays, as well as the subsequent interpretation of these results for the purposes of clinical decision making.

Initial clinical evaluation of PET-based ion beam therapy monitoring under consideration of organ motion.

Science.gov (United States)

Kurz, Christopher; Bauer, Julia; Unholtz, Daniel; Richter, Daniel; Herfarth, Klaus; Debus, Jürgen; Parodi, Katia

2016-02-01

Intrafractional organ motion imposes considerable challenges to scanned ion beam therapy and demands for a thorough verification of the applied treatment. At the Heidelberg Ion-Beam Therapy Center (HIT), the scanned ion beam delivery is verified by means of postirradiation positron-emission-tomography (PET) imaging. This work presents a first clinical evaluation of PET-based treatment monitoring in ion beam therapy under consideration of target motion. Three patients with mobile liver lesions underwent scanned carbon ion irradiation at HIT and postirradiation PET/CT (x-ray-computed-tomography) imaging with a commercial scanner. Respiratory motion was recorded during irradiation and subsequent image acquisition. This enabled a time-resolved (4D) calculation of the expected irradiation-induced activity pattern and, for one patient where an additional 4D CT was acquired at the PET/CT scanner after treatment, a motion-compensated PET image reconstruction. For the other patients, PET data were reconstructed statically. To verify the treatment, calculated prediction and reconstructed measurement were compared with a focus on the ion beam range. Results in the current three patients suggest that for motion amplitudes in the order of 2 mm there is no benefit from incorporating respiratory motion information into PET-based treatment monitoring. For a target motion in the order of 10 mm, motion-related effects become more severe and a time-resolved modeling of the expected activity distribution can lead to an improved data interpretation if a sufficient number of true coincidences is detected. Benefits from motion-compensated PET image reconstruction could not be shown conclusively at the current stage. The feasibility of clinical PET-based treatment verification under consideration of organ motion has been shown for the first time. Improvements in noise-robust 4D PET image reconstruction are deemed necessary to enhance the clinical potential.

Initial clinical evaluation of PET-based ion beam therapy monitoring under consideration of organ motion

International Nuclear Information System (INIS)

Kurz, Christopher; Bauer, Julia; Unholtz, Daniel; Herfarth, Klaus; Debus, Jürgen; Richter, Daniel; Parodi, Katia

2016-01-01

Purpose: Intrafractional organ motion imposes considerable challenges to scanned ion beam therapy and demands for a thorough verification of the applied treatment. At the Heidelberg Ion-Beam Therapy Center (HIT), the scanned ion beam delivery is verified by means of postirradiation positron-emission-tomography (PET) imaging. This work presents a first clinical evaluation of PET-based treatment monitoring in ion beam therapy under consideration of target motion. Methods: Three patients with mobile liver lesions underwent scanned carbon ion irradiation at HIT and postirradiation PET/CT (x-ray-computed-tomography) imaging with a commercial scanner. Respiratory motion was recorded during irradiation and subsequent image acquisition. This enabled a time-resolved (4D) calculation of the expected irradiation-induced activity pattern and, for one patient where an additional 4D CT was acquired at the PET/CT scanner after treatment, a motion-compensated PET image reconstruction. For the other patients, PET data were reconstructed statically. To verify the treatment, calculated prediction and reconstructed measurement were compared with a focus on the ion beam range. Results: Results in the current three patients suggest that for motion amplitudes in the order of 2 mm there is no benefit from incorporating respiratory motion information into PET-based treatment monitoring. For a target motion in the order of 10 mm, motion-related effects become more severe and a time-resolved modeling of the expected activity distribution can lead to an improved data interpretation if a sufficient number of true coincidences is detected. Benefits from motion-compensated PET image reconstruction could not be shown conclusively at the current stage. Conclusions: The feasibility of clinical PET-based treatment verification under consideration of organ motion has been shown for the first time. Improvements in noise-robust 4D PET image reconstruction are deemed necessary to enhance the

28 CFR 16.26 - Considerations in determining whether production or disclosure should be made pursuant to a demand.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Considerations in determining whether production or disclosure should be made pursuant to a demand. 16.26 Section 16.26 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION Production or Disclosure in Federal...

Food Production and Processing Considerations of Allergenic Food Ingredients: A Review

Science.gov (United States)

Alvarez, Pedro A.; Boye, Joyce I.

2012-01-01

Although most consumers show no adverse symptoms to food allergens, health consequences for sensitized individuals can be very serious. As a result, the Codex General Standard for the Labelling of Prepackaged Foods has specified a series of allergenic ingredients/substances requiring mandatory declaration when present in processed prepackaged food products. Countries adhering to international standards are required to observe this minimum of eight substances, but additional priority allergens are included in the list in some countries. Enforcement agencies have traditionally focused their effort on surveillance of prepackaged goods, but there is a growing need to apply a bottom-up approach to allergen risk management in food manufacturing starting from primary food processing operations in order to minimize the possibility of allergen contamination in finished products. The present paper aims to review food production considerations that impact allergen risk management, and it is directed mainly to food manufacturers and policy makers. Furthermore, a series of food ingredients and the allergenic fractions identified from them, as well as the current methodology used for detection of these allergenic foods, is provided. PMID:22187573

Antipsychotic drug treatment for patients with schizophrenia: theoretical background, clinical considerations and patients preferences

DEFF Research Database (Denmark)

Nielsen, René Ernst; Nielsen, Jimmi

2009-01-01

  The cornerstone in treatment of psychosis is antipsychotic drugs. Treatment options have increased over the years; newer antipsychotic drugs with a proposed efficacy regarding negative and cognitive symptoms, but also a shift in side-effects from neurological side-effects to metabolic side......-effects have arisen as the new challenge. The basis of successful pharmacological treatment is a fundamental understanding of the mechanisms of action, the desired effects and side-effects of antipsychotic drugs, a good relationship with the patient and a thorough monitoring of the patient before and during...... treatment. The clinically relevant aspects of antipsychotic drug treatment are reviewed; mechanism of antipsychotic drug action, clinical considerations in treatment, switching antipsychotic drugs, polypharmacy, safety and patient preference.  ...

Semi-spontaneous oral text production: measurements in clinical practice.

Science.gov (United States)

Lind, Marianne; Kristoffersen, Kristian Emil; Moen, Inger; Simonsen, Hanne Gram

2009-12-01

Functionally relevant assessment of the language production of speakers with aphasia should include assessment of connected speech production. Despite the ecological validity of everyday conversations, more controlled and monological types of texts may be easier to obtain and analyse in clinical practice. This article discusses some simple measurements for the analysis of semi-spontaneous oral text production by speakers with aphasia. Specifically, the measurements are related to the production of verbs and nouns, and the realization of different sentence types. The proposed measurements should be clinically relevant, easily applicable, and linguistically meaningful. The measurements have been applied to oral descriptions of the 'Cookie Theft' picture by eight monolingual Norwegian speakers, four with an anomic type of aphasia and four without any type of language impairment. Despite individual differences in both the clinical and the non-clinical group, most of the measurements seem to distinguish between speakers with and without aphasia.

Criteria for the use of monoclonal antibodies, legislation and ethical considerations

International Nuclear Information System (INIS)

Cox, P.H.

1993-01-01

The criteria governing the in vivo use of monoclonal antibodies in humans are based upon a number of legal requirements with respect to radiation hygiene, pharmaceutical legislation, radiopharmaceutical legislation and regulations with respect to products arising from biotechnology. This in itself has led to a complicated situation which has undoubtedly restricted the development of valuable diagnostic and potential therapeutic agents. From the ethical point of view there are also important considerations, firstly with respect to the methods of producing antibodies, which has resulted in the discontinuation of the raising of antibodies in murine ascites, and secondly in consideration of the ethics of administering labelled antibodies to healthy volunteers and to patients who may not necessarily benefit personally from the procedure. These factors must be evaluated in the light of the EEC document 'Good clinical practice for trials in medicinal products in the European Community from the CPMP working party on Efficacy of Medicinal Products'. (author)

Financial remuneration for clinical and behavioral research participation: ethical and practical considerations.

Science.gov (United States)

Permuth-Wey, Jennifer; Borenstein, Amy R

2009-04-01

Although the practice of providing payment to clinical research participants has been ongoing for more than a century, it remains an ethically controversial topic among members of the research community. The aims of this commentary are to summarize ethical and practical considerations regarding financial remuneration of research participants and to make recommendations for researchers contemplating this practice. A PubMed search was conducted to explore the ethical implications surrounding financial remuneration and review the body of empiric data on this topic. Financial remuneration is perceived to be ethically acceptable by many researchers and research participants and can be helpful in the recruitment process. It is recommended that when investigators are contemplating whether to offer payment to research participants, they should consider the nature of the study and the potential benefits and risks to the participants, institutional or organizational guidelines, and cultural and societal norms specific to the population being studied. Financial remuneration has the ability to serve as a sign of appreciation for the contributions of research participants and a way to facilitate clinical and behavioral research.

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

Science.gov (United States)

Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

2015-01-01

In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

Formulary considerations in selection of beta-blockers.

Science.gov (United States)

Yedinak, K C

1993-08-01

Selection of beta-adrenergic blockers for formulary addition can be a difficult task, especially with the increasing availability of new beta-blockers, as well as the numerous differences in pharmacodynamic and pharmacokinetic properties of currently available agents. Nevertheless, appropriate evaluation of the important characteristics of beta-blockers should allow selection of the most cost-effective agents for formulary addition. Most importantly, differences in efficacy, product formulation and cost should be carefully considered when making formulary decisions. Notably, evidence from clinical trials indicates differences in efficacy among beta-blockers for post-myocardial infarction prophylaxis, situational anxiety, essential tremor, thyrotoxicosis, migraine prophylaxis and prevention of bleeding associated with oesophageal varices. For many clinical situations, it is also important to select an effective agent that is available in both an oral and intravenous formulation, especially for cardioprotection after acute myocardial infarction and for use in supraventricular arrhythmias. In addition, availability of sustained release products and generic formulations should be considered for their potential to increase compliance and decrease cost, respectively. Comparative drug costs, as well as costs associated with decreased compliance, should also be carefully evaluated. Differences in beta-receptor selectivity, duration of action and presence of intrinsic sympathomimetic activity (ISA) are also important considerations in the selection of beta-blockers for formulary consideration. Although degree of selectivity is relative, beta 1-selective agents may be less likely to induce bronchospasm in patients with chronic obstructive pulmonary disease (COPD) and may be less likely to affect glucose homeostasis in patients with diabetes mellitus. Duration of action of a beta-blocker is an important consideration for evaluation of efficacy throughout the recommended

Product quality considerations for mammalian cell culture process development and manufacturing.

Science.gov (United States)

Gramer, Michael J

2014-01-01

The manufacturing of a biologic drug from mammalian cells results in not a single substance, but an array of product isoforms, also known as variants. These isoforms arise due to intracellular or extracellular events as a result of biological or chemical modification. The most common examples related to biomanufacturing include amino acid modifications (glycosylation, isomerization, oxidation, adduct formation, pyroglutamate formation, phosphorylation, sulfation, amidation), amino acid sequence variants (genetic mutations, amino acid misincorporation, N- and C-terminal heterogeneity, clipping), and higher-order structure modifications (misfolding, aggregation, disulfide pairing). Process-related impurities (HCP, DNA, media components, viral particles) are also important quality attributes related to product safety. The observed ranges associated with each quality attribute define the product quality profile. A biologic drug must have a correct and consistent quality profile throughout clinical development and scale-up to commercial production to ensure product safety and efficacy. In general, the upstream process (cell culture) defines the quality of product-related substances, whereas the downstream process (purification) defines the residual level of process- and product-related impurities. The purpose of this chapter is to review the impact of the cell culture process on product quality. Emphasis is placed on studies with industrial significance and where the direct mechanism of product quality impact was determined. Where possible, recommendations for maintaining consistent or improved quality are provided.

Legal Considerations in Clinical Decision Making.

Science.gov (United States)

Ursu, Samuel C.

1992-01-01

Discussion of legal issues in dental clinical decision making looks at the nature and elements of applicable law, especially malpractice, locus of responsibility, and standards of care. Greater use of formal decision analysis in clinical dentistry and better research on diagnosis and treatment are recommended, particularly in light of increasing…

Clinical productivity of primary care nurse practitioners in ambulatory settings.

Science.gov (United States)

Xue, Ying; Tuttle, Jane

Nurse practitioners are increasingly being integrated into primary care delivery to help meet the growing demand for primary care. It is therefore important to understand nurse practitioners' productivity in primary care practice. We examined nurse practitioners' clinical productivity in regard to number of patients seen per week, whether they had a patient panel, and patient panel size. We further investigated practice characteristics associated with their clinical productivity. We conducted cross-sectional analysis of the 2012 National Sample Survey of Nurse Practitioners. The sample included full-time primary care nurse practitioners in ambulatory settings. Multivariable survey regression analyses were performed to examine the relationship between practice characteristics and nurse practitioners' clinical productivity. Primary care nurse practitioners in ambulatory settings saw an average of 80 patients per week (95% confidence interval [CI]: 79-82), and 64% of them had their own patient panel. The average patient panel size was 567 (95% CI: 522-612). Nurse practitioners who had their own patient panel spent a similar percent of time on patient care and documentation as those who did not. However, those with a patient panel were more likely to provide a range of clinical services to most patients. Nurse practitioners' clinical productivity was associated with several modifiable practice characteristics such as practice autonomy and billing and payment policies. The estimated number of patients seen in a typical week by nurse practitioners is comparable to that by primary care physicians reported in the literature. However, they had a significantly smaller patient panel. Nurse practitioners' clinical productivity can be further improved. Copyright © 2016 Elsevier Inc. All rights reserved.

First branchial cleft anomaly: clinical insight into its relevance in otolaryngology with pediatric considerations.

Science.gov (United States)

Maithani, Tripti; Pandey, Apporva; Dey, Debraj; Bhardwaj, Aparna; Singh, V P

2014-01-01

First branchial cleft anomalies (FBCA) represent a small subset of congenital malformations in neck. Prime objective of this study is to share our experience with FBCA, emphasize its relevance in otolaryngology and deal with its pediatric perspective. Embryology, pathologic anatomy and varied spectra of clinical presentations of FBCA are discussed. Along with this we have illustrated three different cases; all of them were of pediatric age group and were misdiagnosed by their treating specialists elsewhere. In this article we have also laid special emphasis on its pediatric considerations. FBCA are mostly misdiagnosed due to their unfamiliar clinical signs and symptoms. Swellings may masquerade as other neck masses. Majority of patients give a history of previous incision and drainage. While dealing with pediatric patients the important factors to be kept in mind are the age of child, superficial course of facial nerve, any associated agenesis of parotid gland. Alteration in surgical technique may be required in children. A thorough medical examination with high index of clinical suspicion should be kept in mind while dealing with such anomalies. Owing to their complex presentation and close relation with facial nerve they are challenging lesions for surgeons.

Environmental considerations in energy crop production

International Nuclear Information System (INIS)

Ranney, J.W.; Mann, L.K.

1994-01-01

This paper is a preliminary attempt to provide information on the probable environmental effects of energy crop production relative to other potential uses of the land. While dedicated energy crop production is anticipated to occur primarily on land currently in agricultural production, some pastureland and forestland with a high potential for conversion to agricultural production may be utilized. Experimental results suggest that chemical use on energy crops will be lower than on most row crops and that land producing energy crops should experience less erosion than land producing row crops. Long-term site productivity should not be a major issue if macro-and micro-fertilizers are added as needed and nutrient-conserving production techniques are used. (Author)

Practical and clinical considerations in Cobalt-60 tomotherapy

Directory of Open Access Journals (Sweden)

Joshi Chandra

2009-01-01

Full Text Available Cobalt-60 (Co-60 based radiation therapy continues to play a significant role in not only developing countries, where access to radiation therapy is extremely limited, but also in industrialized countries. Howver, technology has to be developed to accommodate modern techniques, in-clud-ing image guided and adaptive radiation therapy (IGART. In this paper we describe some of the practical and clinical considerations for Co-60 based tomotherapy by comparing Co-60 and 6 MV linac-based tomotherapy plans for a head and neck (HandN cancer and a prostate cancer case. The tomotherapy IMRT plans were obtained by modeling a MIMiC binary multi-leaf collimator attached to a Theratron-780c Co-60 unit and a 6 MV linear accelerator (CL2100EX. The EGSnrc/BEAMnrc Monte Carlo (MC code was used for the modeling of the treatment units with the MIMiC collimator and EGSnrc/DOSXYZnrc code was used for beamlet dose data. An in-house inverse treatment planning program was then used to generate optimized tomotherapy dose distributions for the H and N and prostate cases. The dose distributions, cumulative dose area histograms (DAHs and dose difference maps were used to evaluate and compare Co-60 and 6 MV based tomotherapy plans. A quantitative analysis of the dose distributions and dose-volume histograms shows that both Co-60 and 6 MV plans achieve the plan objectives for the targets (CTV and nodes and OARs (spinal cord in HandN case, and rectum in prostate case.

Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

International Nuclear Information System (INIS)

Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng

2011-01-01

There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

Energy Technology Data Exchange (ETDEWEB)

Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng (Univ. of Florida Proton Therapy Inst., Jacksonville, Florida (United States)), e-mail: menden@shands.ufl.edu

2011-08-15

There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

[What are Considerations for Clinical Investigation of New Drugs and Treatment Techniques for Major Depressive Disorders?].

Science.gov (United States)

Nakabayashi, Tetsuo

2015-01-01

Major depressive disorder treatments remain unsatisfactory, and the development of novel antidepressants is continuing. Therefore, not only the establishment of therapeutic strategies to accumulate evidence on existing therapies, but also the development of novel therapies is required in order to improve the medical standards. In principle, parallel, double-blind, randomized, placebo-controlled trials are necessary to assess new compounds for the treatment of major depressive disorders from a scientific perspective. To provide unambiguous evidence of antidepressant activity, well-controlled studies with adequate designs must show efficacy with a statistically significant effect on a clinically meaningful endpoint. For this purpose, it is important to examine all aspects of factors that adversely affect the efficacy and safety assessment in the planning stage of clinical trials and reduce these factors. There are several specific characteristics of clinical trials for neuropsychiatric disorders. Some typical features are as follows: 1) a high and variable response, 2) impact on the effect of the baseline severity of disorders, 3) high dropout rates, 4) biases related to subjective measures of clinical symptoms. In this paper, considerations for the planning and performing of clinical trials for major depressive disorders will be discussed based on these features.

Ethical and clinical practice considerations for genetic counselors related to direct-to-consumer marketing of genetic tests.

Science.gov (United States)

Wade, Christopher H; Wilfond, Benjamin S

2006-11-15

Several companies utilize direct-to-consumer (DTC) advertising for genetic tests and some, but not all, bypass clinician involvement by offering DTC purchase of the tests. This article examines how DTC marketing strategies may affect genetic counselors, using available cardiovascular disease susceptibility tests as an illustration. The interpretation of these tests is complex and includes consideration of clinical validity and utility, and the further complications of gene-environment interactions and pleiotropy. Although it is unclear to what extent genetic counselors will encounter clients who have been exposed to DTC marketing strategies, these strategies may influence genetic counseling interactions if they produce directed interest in specific tests and unrealistic expectations for the tests' capacity to predict disease. Often, a client's concern about risk for cardiovascular diseases is best addressed by established clinical tests and a family history assessment. Ethical dilemmas may arise for genetic counselors who consider whether to accept clients who request test interpretation or to order DTC-advertised tests that require a clinician's authorization. Genetic counselors' obligations to care for clients extend to interpreting DTC tests, although this obligation may be fulfilled by referral or consultation with specialists. Genetic counselors do not have an obligation to order DTC-advertised tests that have minimal clinical validity and utility at a client's request. This can be a justified restriction on autonomy based on consideration of risks to the client, the costs, and the implications for society. Published 2006 Wiley-Liss, Inc.

The clinical and radiologic consideration of osteosarcoma of the jaws

International Nuclear Information System (INIS)

Ko, Gi Young; Kim, Ki Duck; Park, Chang Seo

1996-01-01

The purpose of this study was to know the proper diagnosis and to establish the treatment plan of the osteosarcoma in the jaws through the clinical, radiological, and histopathologic considerations. The authors compared and analyzed t he clinicoradiologic features of the six cases of osteosarcoma, diagnosed at the dental college hospital in Yonsei University, Seoul, Korea, during the period from 1975 to 1995. The obtained results were as follows; 1. Osteosarcoma occurred in the mean age, 26.2 years, ranged from 14 to 35 years, and equally in men and women. 2. The swelling was the most common frequent presenting complaints. Other reported symptoms included pain, parasthesia of the lower lip or the lesion. 3. The average interval was seen 3.5 months before the patient had been seen by a doctor. 4. The frequency of the lesions was equally in the maxilla, 3 cases and mandible, 3 cases. 5. Radiologically, osteoblastic osteosarcoma which is seen in the 3 cases was the most frequent histologic type. Chondroblastic osteosarcoma were seen in the 2 cases. there was no correlation between the radiologic appearance and histopathologic type.

Considerations for use of dental photography and electronic media in dental education and clinical practice.

Science.gov (United States)

Stieber, Jane C; Nelson, Travis; Huebner, Colleen E

2015-04-01

Photography and electronic media are indispensable tools for dental education and clinical practice. Although previous research has focused on privacy issues and general strategies to protect patient privacy when sharing clinical photographs for educational purposes, there are no published recommendations for developing a functional, privacy-compliant institutional framework for the capture, storage, transfer, and use of clinical photographs and other electronic media. The aims of this study were to research patient rights relating to electronic media and propose a framework for the use of patient media in education and clinical care. After a review of the relevant literature and consultation with the University of Washington's director of privacy and compliance and assistant attorney general, the researchers developed a privacy-compliant framework to ensure appropriate capture, storage, transfer, and use of clinical photography and electronic media. A four-part framework was created to guide the use of patient media that reflects considerations of patient autonomy and privacy, informed consent, capture and storage of media, and its transfer, use, and display. The best practices proposed for capture, storage, transfer, and use of clinical photographs and electronic media adhere to the health care code of ethics (based on patient autonomy, nonmaleficence, beneficence, justice, and veracity), which is most effectively upheld by a practical framework designed to protect patients and limit institutional liability. Educators have the opportunity and duty to convey these principles to students who will become the next generation of dentists, researchers, and educators.

Ownership options, financing structures, and regulatory considerations affecting independent power production projects

International Nuclear Information System (INIS)

Knapp, G.M.

1990-01-01

In this paper is a framework for analysis of the legal, financing, and policy differences between independent power production projects (IPPs) and projects with qualifying facility status (QFs) under the Public Utility Regulatory Policies Act (PURPA). At a basic level, there is no fundamental difference in types of ownership and financing structures available to IPPs and QFS. The key consideration, though, is the regulatory and legal implications to project participants. Significant issues arise for equity participants, lenders, developers, and project operators that are considering IPP projects. Of course, many of these same issues apply to certain types of QF projects that are not fully exempt from the Public Utility Holding Company Act (PUHCA) and the Federal Power Act (FPA)

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

Science.gov (United States)

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.

Connecting Gaucher and Parkinson Disease: Considerations for Clinical and Research Genetic Counseling Settings.

Science.gov (United States)

Cook, Lola; Schulze, Jeanine

2017-12-01

There are multiple autosomal recessive disorders in which carriers may be at risk for other diseases. This observation calls into question the previous understanding that carriers of autosomal recessive disorders escape clinical consequences. We also know that childhood genetic conditions may have adult disease counterparts (Zimran et al., The Israel Medical Association Journal: IMAJ, 16(11), 723-724, 2014). Individuals who have Gaucher disease and carriers of the disorder are at increased risk for a seemingly unrelated and complex neurological condition, Parkinson disease. Parkinson disease is, in part, caused by the same mutations in the GBA gene that lead to Gaucher disease, and the two conditions are thought to have shared pathophysiology. Briefly reviewed are how these two diseases historically became linked, where their paths cross, potential problems and considerations in disclosure of the link, and current guidelines and research in this area. Genetic counseling experience with a large Parkinson disease cohort is used as a starting point to question the state of clinical and nonclinical practice in disclosing this unusual connection We conclude that more research and discussion are needed to inform practice regarding the crossroads of Gaucher and Parkinson disease.

77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

Science.gov (United States)

2012-02-21

...] Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing... ``Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing... for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and...

Acetabular fractures: anatomic and clinical considerations.

Science.gov (United States)

Lawrence, David A; Menn, Kirsten; Baumgaertner, Michael; Haims, Andrew H

2013-09-01

Classifying acetabular fractures can be an intimidating topic. However, it is helpful to remember that there are only three basic types of acetabular fractures: column fractures, transverse fractures, and wall fractures. Within this framework, acetabular fractures are classified into two broad categories: elementary or associated fractures. We will review the osseous anatomy of the pelvis and provide systematic approaches for reviewing both radiographs and CT scans to effectively evaluate the acetabulum. Although acetabular fracture classification may seem intimidating, the descriptions and distinctions discussed and shown in this article hopefully make the topic simpler to understand. Approach the task by recalling that there are only three basic types of acetabular fractures: column fractures (coronally oriented on CT images), transverse fractures (sagittally oriented on CT images), and wall fractures (obliquely oriented on CT images). We have provided systematic approaches for reviewing both conventional radiographs and CT scans to effectively assess the acetabulum. The clinical implications of the different fracture patterns have also been reviewed because it is critically important to include pertinent information for our clinical colleagues to provide the most efficient and timely clinical care.

Contribution of clinical trials to gross domestic product in Hungary.

Science.gov (United States)

Kaló, Zoltán; Antal, János; Pénzes, Miklós; Pozsgay, Csilla; Szepezdi, Zsuzsanna; Nagyjánosi, László

2014-10-01

To determine the contribution of clinical trials to the gross domestic product (GDP) in Hungary. An anonymous survey of pharmaceutical companies and clinical research organizations (CROs) was conducted to estimate their clinical trial-related employment and revenues. Clinical trial documents at the National Institute of Pharmacy (NIP) were analyzed to estimate trial-related revenues at health care institutions and the value of investigational medical products (IMPs) based on avoided drug costs. Financial benefits were calculated as 2010 US $ purchasing power parity (PPP) values. Clinical trials increased the revenue of Hungarian health care providers by 1 US $65.6 million. The value of IMPs was US $67.0 million. Clinical trial operation and management activities generated 900 jobs and US $166.9 million in revenue among CROs and pharmaceutical companies. The contribution of clinical trials to the Hungarian GDP in 2010 amounted to 0.2%. Participation in international clinical trials may result in health, financial, and intangible benefits that contribute to the sustainability of health care systems, especially in countries with severe resource constraints. Although a conservative approach was employed to estimate the economic benefits of clinical trials, further research is necessary to improve the generalizability of our findings.

Cultural Differences in Opportunity Cost Consideration.

Science.gov (United States)

Zhang, Ning; Ji, Li-Jun; Li, Ye

2017-01-01

Two studies were conducted to investigate cultural differences in opportunity cost consideration between Chinese and Euro-Canadians. Opportunity cost is defined as the cost of a benefit that must be forgone in order to pursue a better alternative (Becker et al., 1974). In both studies, participants read about hypothetical purchase scenarios, and then decided whether they would buy a certain product. Opportunity cost consideration was measured in two ways: (1) participants' thoughts pertaining to other (nonfocal) products while making decisions; (2) participants' decisions not to buy a focal product (Study 1) or a more expensive product (Study 2). Across both indexes, we found that after controlling for individual difference variables and amount of pocket money, Chinese participants in China considered financial opportunity cost more than Euro-Canadians in Study 1. Similar results were observed in Study 2 when comparing Chinese in Canada with Euro-Canadians However, the cultural effect on opportunity cost consideration was confounded by family income in Study 2. Implications for resource management, limitations of the current research and directions for future research are discussed.

Semi-Spontaneous Oral Text Production: Measurements in Clinical Practice

Science.gov (United States)

Lind, Marianne; Kristoffersen, Kristian Emil; Moen, Inger; Simonsen, Hanne Gram

2009-01-01

Functionally relevant assessment of the language production of speakers with aphasia should include assessment of connected speech production. Despite the ecological validity of everyday conversations, more controlled and monological types of texts may be easier to obtain and analyse in clinical practice. This article discusses some simple…

Clinical photography in dermatology: ethical and medico-legal considerations in the age of digital and smartphone technology.

Science.gov (United States)

Kunde, Lauren; McMeniman, Erin; Parker, Malcolm

2013-08-01

Clinical photography has long been an important aspect in the management of dermatological pathology and has many applications in contemporary dermatology practice. With the continuous evolution of digital and smartphone technology, clinicians must maintain ethical and medico-legal standards. This article reviews how dermatology trainees are utilising this technology in their clinical practice and what procedures they follow when taking photos of patients. We review the ethical and legal considerations of clinical photography in dermatology and present a hypothetical medico-legal scenario. Dermatology registrars were surveyed on their use of personal smartphones and digital equipment for photographing patients in their clinical practice. Numerous medico-legal providers were approached to provide medico-legal advice about a hypothetical scenario. We found that the use of these technologies is prevalent among dermatology registrars and all respondents reported regular use. Clinicians should routinely obtain and document adequate patient consent in relation to clinical photography, utilise strict privacy settings on smartphones and other digital devices and ensure that the images are stored on these devices for minimal periods. Express consent documentation in the clinical file puts the clinician in a more defensible position if a complaint is made to the medical board or privacy commissioner. © 2013 The Authors. Australasian Journal of Dermatology © 2013 The Australasian College of Dermatologists.

Regulatory considerations concerning IND radiopharmaceutical drug products

International Nuclear Information System (INIS)

Nissel, M.

1985-01-01

The Food and Drug Administration is charged by the Food, Drug, and Cosmetic Act, as presently amended, to assure that any drug introduced into interstate commerce is safe and effective for the purposes for which it is labeled. A radiopharmaceutical is, by definition, a new drug unless there is in effect an approved New Drug Application (NDA) for it. Before the data for the NDA are compiled, investigative studies have to be done. Before such studies can be performed in humans, an exemption from the Act is necessary. This exemption, technically the Claimed Exemption for an Investigational New Drug, is termed the IND. Both the scientific and the administrative requirements for an IND are discussed. For radiopharmaceutical drug products (RDP's), the radiation hazards, as well as the pharmacological ones, must be documented. Should the early studies demonstrate a potential for efficacy in a certain condition or disease state, an investigative protocol for an extended clinical trial is presented. The necessary requirements for Institutional Review Board (IRB) approval and consent forms are discussed. For certain research purposes, uniquely for radioactive drugs, an IND is not required for certain specific studies; the requirements for such a research study, conducted under the auspices of an approved radioactive drug research committee, are outlined

Insurance considerations associated with radiation processing

International Nuclear Information System (INIS)

Boylan, F.X.

1979-01-01

Comments are made on nuclear insurance experience in the United States. The subject is discussed in more detail under the headings: direct physical damage insurance; workers' compensation insurance; third party liability (premises and operations considerations; products considerations); possible alternatives to the existing arrangement. (U.K.)

Bipolar disorder and complementary medicine: current evidence, safety issues, and clinical considerations.

Science.gov (United States)

Sarris, Jerome; Lake, James; Hoenders, Rogier

2011-10-01

Bipolar disorder (BD) is a debilitating syndrome that is often undiagnosed and undertreated. Population surveys show that persons with BD often self-medicate with complementary and alternative medicine (CAM) or integrative therapies in spite of limited research evidence supporting their use. To date, no review has focused specifically on nonconventional treatments of BD. The study objectives were to present a review of nonconventional (complementary and integrative) interventions examined in clinical trials on BD, and to offer provisional guidelines for the judicious integrative use of CAM in the management of BD. PubMed, CINAHL,(®) Web of Science, and Cochrane Library databases were searched for human clinical trials in English during mid-2010 using Bipolar Disorder and CAM therapy and CAM medicine search terms. Effect sizes (Cohen's d) were also calculated where data were available. Several positive high-quality studies on nutrients in combination with conventional mood stabilizers and antipsychotic medications in BD depression were identified, while branched-chain amino acids and magnesium were effective (small studies) in attenuating mania in BD. In the treatment of bipolar depression, evidence was mixed regarding omega-3, while isolated studies provide provisional support for a multinutrient formula, n-acetylcysteine, and l-tryptophan. In one study, acupuncture was found to have favorable but nonsignificant effects on mania and depression outcomes. Current evidence supports the integrative treatment of BD using combinations of mood stabilizers and select nutrients. Other CAM or integrative modalities used to treat BD have not been adequately explored to date; however, some early findings are promising. Select CAM and integrative interventions add to established conventional treatment of BD and may be considered when formulating a treatment plan. It is hoped that the safety issues and clinical considerations addressed in this article may encourage the practice

Laboratory research at the clinical trials of Veterinary medicinal Products

OpenAIRE

ZHYLA M.I.

2011-01-01

The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.

[Atosiban treatment for preterm labor--financial considerations and savings by implementing clinical guidelines].

Science.gov (United States)

Hadar, Eran; Mansur, Nariman; Ambar, Irit; Hod, Moshe

2011-06-01

Preterm delivery is a significant cause of neonatal morbidity and mortality. Pregnant women, with symptoms and signs consistent with preterm labor, can be treated with various tocolytic drugs. Atosiban is one of many drugs indicated to arrest imminent preterm labor. Various studies show that the efficacy of atosiban is similar to other tocolytic drugs. The main advantage of atosiban is a relativeLy low incidence of adverse maternal reactions. Its considerable shortcoming is the financial cost, compared to other available drugs. In view of its cost, we have decided to implement a strict protocol to direct the use of atosiban, with the intent to reduce costs, without hampering quality of care. The protocol was implemented from July 2009, and it outlines the medical and procedural terms to use atosiban. We compared similar time periods before and after implementation of the protocol. The outcomes compared included: treatment success, rates of preterm deliveries and financial costs. Within the timeframe that the protocol was implemented, we have been able to demonstrate a 40% reduction in atosiban related costs, compared to a parallel period, when the clinical guidelines were not implemented. This translates into savings of about NIS 40,000 (New Israeli Shekel) (approximately $10,000). This was achieved without an increase in the rate of preterm deliveries. Implementing and enforcing a simple protocol of supervision on the use of atosiban enables a considerable reduction of financial costs related to atosiban, without hampering medical care.

Evaluation of the physicians‘ of n hospital opinion on clinical trials of medicinal products

OpenAIRE

Videikaitė, Lina

2014-01-01

Aim of the research. To evaluate the physicians‘ of N Hospital opinion on clinical trials of medicinal products. Objectives. To evaluate the factors affecting physicians' motivation to perform clinical trials of medicinal products as well as those that prevent the physicians getting involved in the trials. To assess physicians' attitude towards clinical trials of medicinal products. To compare the opinions of physicians who have and have’nt participated in clinical trials. Methods of...

Clinical efficiency, image quality and dosimetric considerations

Energy Technology Data Exchange (ETDEWEB)

Arreola, M. [Director of Clinical Radiological Physics, Shands Hospital at the University of Florida College of Medicine, Gainesville, FL (United States)

2000-07-01

Three decades have passed since the first clinical use of the famous EMI Computed Axial Tomography (Cat) scanner. At the time, the prospects for clinical success of this innovative idea were not very good. Time, however, has proven otherwise as what is now simply known as Computed tomography (CT) has been boosted in each one of these decades for different reasons. In the 1970s, technological progress augmented by the realization of the importance of tomographic imaging got everything started; in the 1980s, the boom in health care demand in the US solidified its position and in the 1990s the technological explosion in computers and the imperative need to lower costs in the health care industry have prompted the most dramatic changes in the wy CT is utilized in the year 2000. Thus, different motivations have led the way of progress in CT at various times, and in spite of amazing developments in other crucial imaging modalities, such as ultrasound, Doppler ultrasound, digital subtraction angiography and magnetic resonance imaging, CT maintains its rightful place as the premiere imaging modality in the modern radiology department. This work covers the basic principles of tomographic image reconstruction, and how axial CT scanners progressed historically in the first two decades. Developments in X-ray tubes, and detection systems are highlighted, as well as the impact of clinical efficiency, image quality and patient doses. The basic construction of translate-rotate (1st and 2nd generation), rotate-rotate (3rd generation) and detector ring (4th generation) scanners are described. The so-called 5th generation scanner, the electron beam scanner, is also described, with its clinical and technical advantages and its inherent financial and maintenance disadvantages, which brought the advent of spiral and multi-slice scanners. These most recent developments in CT technology have opened a new era in the clinical use of CT; and although image quality has reached an expected

Clinical efficiency, image quality and dosimetric considerations

International Nuclear Information System (INIS)

Arreola, M.

2000-01-01

Three decades have passed since the first clinical use of the famous EMI Computed Axial Tomography (Cat) scanner. At the time, the prospects for clinical success of this innovative idea were not very good. Time, however, has proven otherwise as what is now simply known as Computed tomography (CT) has been boosted in each one of these decades for different reasons. In the 1970s, technological progress augmented by the realization of the importance of tomographic imaging got everything started; in the 1980s, the boom in health care demand in the US solidified its position and in the 1990s the technological explosion in computers and the imperative need to lower costs in the health care industry have prompted the most dramatic changes in the wy CT is utilized in the year 2000. Thus, different motivations have led the way of progress in CT at various times, and in spite of amazing developments in other crucial imaging modalities, such as ultrasound, Doppler ultrasound, digital subtraction angiography and magnetic resonance imaging, CT maintains its rightful place as the premiere imaging modality in the modern radiology department. This work covers the basic principles of tomographic image reconstruction, and how axial CT scanners progressed historically in the first two decades. Developments in X-ray tubes, and detection systems are highlighted, as well as the impact of clinical efficiency, image quality and patient doses. The basic construction of translate-rotate (1st and 2nd generation, rotate-rotate (3rd generation) and detector ring (4th generation) scanners are described. The so-called 5th generation scanner, the electron beam scanner, is also described, with its clinical and technical advantages and its inherent financial and maintenance disadvantages, which brought the advent of spiral and multi-slice scanners. These most recent developments in CT technology have opened a new era in the clinical use of CT; and although image quality has reached an expected

Aligning clinical compensation with clinical productivity: design and implementation of the financial value unit (FVU) system in an academic department of internal medicine.

Science.gov (United States)

Stites, Steven; Steffen, Patrick; Turner, Scott; Pingleton, Susan

2013-07-01

A new metric was developed and implemented at the University of Kansas School of Medicine Department of Internal Medicine, the financial value unit (FVU). This metric analyzes faculty clinical compensation compared with clinical work productivity as a transparent means to decrease the physician compensation variability and compensate faculty equitably for clinical work.The FVU is the ratio of individual faculty clinical compensation compared with their total work relative value units (wRVUs) generated divided by Medical Group Management Association (MGMA) salary to wRVUs of a similar MGMA physician.The closer the FVU ratio is to 1.0, the closer clinical compensation is to that of an MGMA physician with similar clinical productivity. Using FVU metrics to calculate a faculty salary gap compared with MGMA median salary and wRVU productivity, a divisional production payment was established annually.From FY 2006 to FY 2011, both total faculty numbers and overall clinical activity increased. With the implementation of the FVU, both clinical productivity and compensation increased while, at the same time, physician retention rates remained high. Variability in physician compensation decreased. Dramatic clinical growth was associated with the alignment of clinical work and clinical compensation in a transparent and equable process.

Production of lentiviral vectors

Directory of Open Access Journals (Sweden)

Otto-Wilhelm Merten

2016-01-01

Full Text Available Lentiviral vectors (LV have seen considerably increase in use as gene therapy vectors for the treatment of acquired and inherited diseases. This review presents the state of the art of the production of these vectors with particular emphasis on their large-scale production for clinical purposes. In contrast to oncoretroviral vectors, which are produced using stable producer cell lines, clinical-grade LV are in most of the cases produced by transient transfection of 293 or 293T cells grown in cell factories. However, more recent developments, also, tend to use hollow fiber reactor, suspension culture processes, and the implementation of stable producer cell lines. As is customary for the biotech industry, rather sophisticated downstream processing protocols have been established to remove any undesirable process-derived contaminant, such as plasmid or host cell DNA or host cell proteins. This review compares published large-scale production and purification processes of LV and presents their process performances. Furthermore, developments in the domain of stable cell lines and their way to the use of production vehicles of clinical material will be presented.

Research design considerations for chronic pain prevention clinical trials

DEFF Research Database (Denmark)

Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C

2015-01-01

Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations...

Clinical evidence for orphan medicinal products-a cause for concern?

NARCIS (Netherlands)

Picavet, Eline; Cassiman, David; Hollak, Carla E.; Maertens, Johan A.; Simoens, Steven

2013-01-01

The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at

Ethical considerations in industry-sponsored multiregional clinical trials.

Science.gov (United States)

Ibia, Ekopimo; Binkowitz, Bruce; Saillot, Jean-Louis; Talerico, Steven; Koerner, Chin; Ferreira, Irene; Agarwal, Anupam; Metz, Craig; Maman, Marianne

2010-01-01

During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider. Copyright © 2010 John Wiley & Sons, Ltd.

Electrochemical sensors for identifying pyocyanin production in clinical Pseudomonas aeruginosa isolates.

Science.gov (United States)

Sismaet, Hunter J; Pinto, Ameet J; Goluch, Edgar D

2017-11-15

In clinical practice, delays in obtaining culture results impact patient care and the ability to tailor antibiotic therapy. Despite the advancement of rapid molecular diagnostics, the use of plate cultures inoculated from swab samples continues to be the standard practice in clinical care. Because the inoculation culture process can take between 24 and 48h before a positive identification test can be run, there is an unmet need to develop rapid throughput methods for bacterial identification. Previous work has shown that pyocyanin can be used as a rapid, redox-active biomarker for identifying Pseudomonas aeruginosa in clinical infections. However, further validation is needed to confirm pyocyanin production occurs in all clinical strains of P. aeruginosa. Here, we validate this electrochemical detection strategy using clinical isolates obtained from patients with hospital-acquired infections or with cystic fibrosis. Square-wave voltammetric scans of 94 different clinical P. aeruginosa isolates were taken to measure the concentration of pyocyanin. The results showed that all isolates produced measureable concentrations of pyocyanin with production rates correlated with patient symptoms and comorbidity. Further bioinformatics analysis confirmed that 1649 genetically sequenced strains (99.9%) of P. aeruginosa possess the two genes (PhzM and PhzS) necessary to produce pyocyanin, supporting the specificity of this biomarker. Confirming the production of pyocyanin by all clinically-relevant strains of P. aeruginosa is a significant step towards validating this strategy for rapid, point-of-care diagnostics. Copyright © 2017 Elsevier B.V. All rights reserved.

Electronic cigarettes: product characterisation and design considerations.

Science.gov (United States)

Brown, Christopher J; Cheng, James M

2014-05-01

To review the available evidence regarding electronic cigarette (e-cigarette) product characterisation and design features in order to understand their potential impact on individual users and on public health. Systematic literature searches in 10 reference databases were conducted through October 2013. A total of 14 articles and documents and 16 patents were included in this analysis. Numerous disposable and reusable e-cigarette product options exist, representing wide variation in product configuration and component functionality. Common e-cigarette components include an aerosol generator, a flow sensor, a battery and a nicotine-containing solution storage area. e-cigarettes currently include many interchangeable parts, enabling users to modify the character of the delivered aerosol and, therefore, the product's 'effectiveness' as a nicotine delivery product. Materials in e-cigarettes may include metals, rubber and ceramics. Some materials may be aerosolised and have adverse health effects. Several studies have described significant performance variability across and within e-cigarette brands. Patent applications include novel product features designed to influence aerosol properties and e-cigarette efficiency at delivering nicotine. Although e-cigarettes share a basic design, engineering variations and user modifications result in differences in nicotine delivery and potential product risks. e-cigarette aerosols may include harmful and potentially harmful constituents. Battery explosions and the risks of exposure to the e-liquid (especially for children) are also concerns. Additional research will enhance the current understanding of basic e-cigarette design and operation, aerosol production and processing, and functionality. A standardised e-cigarette testing regime should be developed to allow product comparisons.

[Basic considerations during outsourcing of clinical data management services].

Science.gov (United States)

Shen, Tong; Liu, Yan

2015-11-01

With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

Developing maximal neuromuscular power: part 2 - training considerations for improving maximal power production.

Science.gov (United States)

Cormie, Prue; McGuigan, Michael R; Newton, Robert U

2011-02-01

This series of reviews focuses on the most important neuromuscular function in many sport performances: the ability to generate maximal muscular power. Part 1, published in an earlier issue of Sports Medicine, focused on the factors that affect maximal power production while part 2 explores the practical application of these findings by reviewing the scientific literature relevant to the development of training programmes that most effectively enhance maximal power production. The ability to generate maximal power during complex motor skills is of paramount importance to successful athletic performance across many sports. A crucial issue faced by scientists and coaches is the development of effective and efficient training programmes that improve maximal power production in dynamic, multi-joint movements. Such training is referred to as 'power training' for the purposes of this review. Although further research is required in order to gain a deeper understanding of the optimal training techniques for maximizing power in complex, sports-specific movements and the precise mechanisms underlying adaptation, several key conclusions can be drawn from this review. First, a fundamental relationship exists between strength and power, which dictates that an individual cannot possess a high level of power without first being relatively strong. Thus, enhancing and maintaining maximal strength is essential when considering the long-term development of power. Second, consideration of movement pattern, load and velocity specificity is essential when designing power training programmes. Ballistic, plyometric and weightlifting exercises can be used effectively as primary exercises within a power training programme that enhances maximal power. The loads applied to these exercises will depend on the specific requirements of each particular sport and the type of movement being trained. The use of ballistic exercises with loads ranging from 0% to 50% of one-repetition maximum (1RM) and

Clinical utility of marketing terms used for over-the-counter dermatologic products.

Science.gov (United States)

Boozalis, Emily; Patel, Shivani

2018-05-08

Cosmetic products are commonly marketed using dermatologic terms such as 'hypoallergenic', 'non-comedogenic', 'fragrance-free', etc. The clinical relevance of these claims can be confusing to both patients and clinicians. A systematic review was performed via a PubMed search of published articles from January 1985 to October 2017 to further describe and elucidate the clinical utility of a predefined list of common dermatologic terms used by pharmaceutical companies to market over-the-counter products. The terms 'fragrance-free', 'hypoallergenic', 'non-comedogenic', and 'oil-free' on cosmetic product labels are not regulated by any governing body and provide varied clinical utility. Products labeled as having 'natural ingredients' are not necessarily safer or less irritating to patients with atopy or a history of allergic contact dermatitis. Despite the increasing popularity of 'paraben-free' cosmetics, parabens are safe for patients in the quantities used in cosmetic products and can be safely used in patients who do not exhibit contact dermatitis to this preservative. A working knowledge of common cosmetic ingredients may help dermatologists to counsel patients on which products to avoid for their specific dermatologic conditions.

Measuring and managing radiologist productivity, part 1: clinical metrics and benchmarks.

Science.gov (United States)

Duszak, Richard; Muroff, Lawrence R

2010-06-01

Physician productivity disparities are not uncommonly debated within radiology groups, sometimes in a contentious manner. Attempts to measure productivity, identify and motivate outliers, and develop equitable management policies can present challenges to private and academic practices alike but are often necessary for a variety of professional, financial, and personnel reasons. This is the first of a two-part series that will detail metrics for evaluating radiologist productivity and review published benchmarks, focusing primarily on clinical work. Issues and limitations that may prevent successful implementation of measurement systems are explored. Part 2 will expand that discussion to evaluating nonclinical administrative and academic activities, outlining advantages and disadvantages of addressing differential productivity, and introducing potential models for practices seeking to motivate physicians on the basis of both clinical and nonclinical work.

Clinical research in dermatology: resources and activities associated with a higher scientific productivity.

Science.gov (United States)

Molina-Leyva, Alejandro; Descalzo, Miguel A; García-Doval, Ignacio

2018-03-06

Clinical research papers and their derived metrics can be useful to assess the scientific production of medical and research centers. Diverse factors are probably associated to differences in scientific production. But there are scarce studies analyzing them. Resources are limited and have to be distributed efficiently. The objective of this study is to explore what resources and activities are potentially associated with a higher scientific productivity. A bibliometric study was performed to obtain information about scientific productivity. Papers included had to meet criteria to be considered clinical research in dermatology, additionally had to be published between the years 2005-2014, had to be included in Pubmed or Embase and had to include a Spanish center of dermatology as the correspondence address. Information about research resources and activities of the year 2015 was gathered by means of an online survey sent to the authors identified in the bibliometric study. The search strategy returned 8617 papers and only 1104 of them (12.81%) met the inclusion criteria. 63 out of 113 centers responded to the survey (55.75%). Factors associated with a higher scientific productivity were: the size of the resident program, the amount of time specifically dedicated to research, a lower clinical workload, and the number of clinical trials performed in the last year. We have demonstrated that some factors are associated with a higher scientific productivity. Residency program, more research staff, clinical workload redistribution and research motivation/initiatives are key strategies that could improve scientific productivity of a center.

Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

Science.gov (United States)

Takahashi, K; Sengoku, S; Kimura, H

2011-02-01

A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.

Endo-perio lesions: Diagnosis and clinical considerations

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Shenoy Nina

2010-01-01

Full Text Available The interrelationship between periodontal and endodontic disease has aroused confusion, queries and controversy. Differentiating between periodontal and endodontic problems can be difficult. A symptomatic tooth may have pain of periodontal and/or pulpal origin. The nature of that pain is often the first clue in determining the etiology of such a problem. Radiographic and clinical evaluation can help clarify the nature of the problem. In some cases, the influence of pulpal pathology may create periodontal involvement. In others, periodontal pathology may create pulpal pathology. This review article discusses the various clinical aspects to be considered for accurately diagnosing and treating endo-perio lesions.

Ozone exposure and pulmonary effects in panel and human clinical studies: Considerations for design and interpretation.

Science.gov (United States)

Rohr, Annette C

2018-04-01

A wealth of literature exists regarding the pulmonary effects of ozone, a photochemical pollutant produced by the reaction of nitrogen oxide and volatile organic precursors in the presence of sunlight. This paper focuses on epidemiological panel studies and human clinical studies of ozone exposure, and discusses issues specific to this pollutant that may influence study design and interpretation as well as other, broader considerations relevant to ozone-health research. The issues are discussed using examples drawn from the wider literature. The recent panel and clinical literature is also reviewed. Health outcomes considered include lung function, symptoms, and pulmonary inflammation. Issues discussed include adversity, reversibility, adaptation, variability in ozone exposure metric used and health outcomes evaluated, co-pollutants in panel studies, influence of temperature in panel studies, and multiple comparisons. Improvements in and standardization of panel study approaches are recommended to facilitate comparisons between studies as well as meta-analyses. Additional clinical studies at or near the current National Ambient Air Quality Standard (NAAQS) of 70 ppb are recommended, as are clinical studies in sensitive subpopulations such as asthmatics. The pulmonary health impacts of ozone exposure have been well documented using both epidemiological and chamber study designs. However, there are a number of specific methodological and related issues that should be considered when interpreting the results of these studies and planning additional research, including the standardization of exposure and health metrics to facilitate comparisons among studies.

Metastatic Breast Cancer With ESR1 Mutation: Clinical Management Considerations From the Molecular and Precision Medicine (MAP) Tumor Board at Massachusetts General Hospital.

Science.gov (United States)

Bardia, Aditya; Iafrate, John A; Sundaresan, Tilak; Younger, Jerry; Nardi, Valentina

2016-09-01

: The last decade in oncology has witnessed impressive response rates with targeted therapies, largely because of collaborative efforts at understanding tumor biology and careful patient selection based on molecular fingerprinting of the tumor. Consequently, there has been a push toward routine molecular genotyping of tumors, and large precision medicine-based clinical trials have been launched to match therapy to the molecular alteration seen in a tumor. However, selecting the "right drug" for an individual patient in clinic is a complex decision-making process, including analytical interpretation of the report, consideration of the importance of the molecular alteration in driving growth of the tumor, tumor heterogeneity, the availability of a matched targeted therapy, efficacy and toxicity considerations of the targeted therapy (compared with standard therapy), and reimbursement issues. In this article, we review the key considerations involved in clinical decision making while reviewing a molecular genotyping report. We present the case of a 67-year-old postmenopausal female with metastatic estrogen receptor-positive (ER+) breast cancer, whose tumor progressed on multiple endocrine therapies. Molecular genotyping of the metastatic lesion revealed the presence of an ESR1 mutation (encoding p.Tyr537Asn), which was absent in the primary tumor. The same ESR1 mutation was also detected in circulating tumor DNA (ctDNA) extracted from her blood. The general approach for interpretation of genotyping results, the clinical significance of the specific mutation in the particular cancer, potential strategies to target the pathway, and implications for clinical practice are reviewed in this article. ER+ breast tumors are known to undergo genomic evolution during treatment with the acquisition of new mutations that confer resistance to treatment.ESR1 mutations in the ligand-binding domain of ER can lead to a ligand-independent, constitutively active form of ER and mediate

Risk assessment considerations for plant protection products and terrestrial life-stages of amphibians.

Science.gov (United States)

Weltje, Lennart; Ufer, Andreas; Hamer, Mick; Sowig, Peter; Demmig, Sandra; Dechet, Friedrich

2018-04-28

Some amphibians occur in agricultural landscapes during certain periods of their life cycle and consequently might be exposed to plant protection products (PPPs). While the sensitivity of aquatic life-stages is considered to be covered by the standard assessment for aquatic organisms (especially fish), the situation is less clear for terrestrial amphibian life-stages. In this paper, considerations are presented on how a risk assessment for PPPs and terrestrial life-stages of amphibians could be conducted. It discusses available information concerning the toxicity of PPPs to terrestrial amphibians, and their potential exposure to PPPs in consideration of aspects of amphibian biology. The emphasis is on avoiding additional vertebrate testing as much as possible by using exposure-driven approaches and by making use of existing vertebrate toxicity data, where appropriate. Options for toxicity testing and risk assessment are presented in a flowchart as a tiered approach, progressing from a non-testing approach, to simple worst-case laboratory testing, to extended laboratory testing, to semi-field enclosure tests and ultimately to full-scale field testing and monitoring. Suggestions are made for triggers to progress to higher tiers. Also, mitigation options to reduce the potential for exposure of terrestrial life-stages of amphibians to PPPs, if a risk were identified, are discussed. Finally, remaining uncertainties and research needs are considered by proposing a way forward (road map) for generating additional information to inform terrestrial amphibian risk assessment. Copyright © 2018 Elsevier B.V. All rights reserved.

Measuring and managing radiologist productivity, part 2: beyond the clinical numbers.

Science.gov (United States)

Duszak, Richard; Muroff, Lawrence R

2010-07-01

Radiology practices endeavoring to measure physician productivity, identify and motivate performance outliers, and develop equitable management strategies and policies often encounter numerous challenges. Nonetheless, such efforts are often necessary, in both private and academic settings, for a variety of professional, financial, and personnel reasons. Part 1 of this series detailed metrics for evaluating radiologist productivity and reviewed published benchmarks, focusing on clinical work. This segment expands that discussion to evaluating nonclinical administrative and academic efforts, along with professionalism and quality, outlining advantages and disadvantages of addressing differential productivity, and introducing potential models for practices seeking to motivate physicians on the basis of both their clinical and nonclinical endeavors. Copyright 2010 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Some products from CLRI under clinical use and evaluation

Indian Academy of Sciences (India)

First page Back Continue Last page Overview Graphics. Some products from CLRI under clinical use and evaluation. As burn dressing materials. As wound healing support system. In dentistry: in treatment of gingivial recession. In ophthalmology: as lens support system.

Annual impact of scribes on physician productivity and revenue in a cardiology clinic.

Science.gov (United States)

Bank, Alan J; Gage, Ryan M

2015-01-01

Scribes are increasingly being used in clinics to assist physicians with documentation during patient care. The annual effect of scribes in a real-world clinic on physician productivity and revenue has not been evaluated. We performed a retrospective study comparing the productivity during routine clinic visits of ten cardiologists using scribes vs 15 cardiologists without scribes. We tracked patients per hour and patients per year seen per physician. Average direct revenue (clinic visit) and downstream revenue (cardiovascular revenue in the 2 months following a clinic visit) were measured in 486 patients and used to calculate annual revenue generated as a result of increased productivity. Physicians with scribes saw 955 new and 4,830 follow-up patients vs 1,318 new and 7,150 follow-up patients seen by physicians without scribes. Physicians with scribes saw 9.6% more patients per hour (2.50±0.27 vs 2.28±0.15, Pproductivity resulted in 84 additional new and 423 additional follow-up patients seen, 3,029 additional work relative value units (wRVUs) generated, and an increased cardiovascular revenue of $1,348,437. Physicians with scribes also generated an additional revenue of $24,257 by producing clinic notes that were coded at a higher level. Total additional revenue generated was $1,372,694 at a cost of $98,588 for the scribes. Physician productivity in a cardiology clinic was ∼10% higher for physicians using scribes. This improved productivity resulted in 84 additional new and 423 additional follow-up patients seen in 1 year. The use of scribes resulted in the generation of 3,029 additional wRVUs and an additional annual revenue of $1,372,694 at a cost of $98,588.

Smallpox: clinical highlights and considerations for vaccination.

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Mahoney M

2003-01-01

Full Text Available Smallpox virus has gained considerable attention as a potential bioterrorism agent. Recommendations for smallpox (vaccinia vaccination presume a low risk for use of smallpox as a terrorist biological agent and vaccination is currently recommended for selected groups of individuals such as health care workers, public health authorities, and emergency/rescue workers, among others. Information about adverse reactions to the smallpox vaccine is based upon studies completed during the 1950s and 1960s. The prevalence of various diseases has changed over the last four decades and new disease entities have been described during this period. The smallpox vaccination may be contra-indicated in many of these conditions. This has made pre-screening of potential vaccines necessary. It is believed that at present, the risks of vaccine-associated complications far outweigh the potential benefits of vaccination in the general population.

68Ga-Based Radiopharmaceuticals: Production and Application Relationship

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Irina Velikyan

2015-07-01

Full Text Available The contribution of 68Ga to the promotion and expansion of clinical research and routine positron emission tomography (PET for earlier better diagnostics and individualized medicine is considerable. The potential applications of 68Ga-comprising imaging agents include targeted, pre-targeted and non-targeted imaging. This review discusses the key aspects of the production of 68Ga and 68Ga-based radiopharmaceuticals in the light of the impact of regulatory requirements and endpoint pre-clinical and clinical applications.

Ethical considerations in stem cell research on neurologic and orthopedic conditions.

Science.gov (United States)

Banja, John Dennis

2015-04-01

The range and gravity of ethical considerations in stem cell research are remarkable and, quite possibly, unprecedented. From the point of securing stem cells for implantation, through the translational and first-in-humans process, and then proceeding through clinical trials culminating in product or service line launch, the entire research trajectory is replete with risk, uncertainty, and problems overweighing foreseeable harms against hoped-for benefits. This article offers an overview of some of the most salient ethical challenges of stem cell research, including ones involving moral status, the intersection of research risks and informed consent processes, methodologic considerations in early phase 1 trials, the temptation to exaggerate the benefits of research discoveries, managing conflicts of interest, and the ethical obligation to conduct various monitoring practices throughout a trial, which could last years. The article will conclude with a glimpse into the future of these technologies wherein the need for ethical scrutiny will likely not diminish. Copyright © 2015. Published by Elsevier Inc.

CONSIDERATIONS UPON MILK AND DAIRY PRODUCT PRODUCTION IN THE U.S.A.

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AGATHA POPESCU

2008-05-01

Full Text Available The paper aimed to present the evolution of milk production and dairy products in the USA during the period 2004-2006, based on USDA Statistics. The USA is a top produce of milk and dairy products in the world. Milk production accounted for 181,798 Millions Pounds in the year 2006. Its continuously increase during the last years has been positively influenced by the increasing number of dairy cows and average milk yield . The top states are California, Wisconsin, New York, Idaho and Pennsylvania, which all together achieve about 54 % of the country milk production. Over 99.37 % of Milk Production is marketed. Considering all milk marketings, Million USD 23,422 cash receiptscould be obtained from a dairy farm in the year 2006. The average return per Cwt was about USD 13 in 2006 . Milk is processed by about 1,000 manufacturing plants in a large variety of dairy products. Cheese production was about 9.5 Billion Pounds in the last analyzed years. The US also produces important amounts of butter , yogurt, ice cream etc. About 8.3 % of the US dairy products are exported, the most markets being Japan, Mexico and Canada.

Clinical utility and patient consideration in the use of lenalidomide for multiple myeloma in Chinese patients

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Wang J

2015-06-01

Full Text Available Jing Wang, Hongfeng Guo, Xin Zhou Department of Hematology, Wuxi People’s Hospital, Nanjing Medical University, Wuxi, People’s Republic of China Abstract: Multiple myeloma (MM is an incurable hematologic malignancy caused by the autonomous growth of malignant plasma cells. In the last decade, the introduction of novel targeted agents such as thalidomide, bortezomib, and lenalidomide has dramatically improved the clinical outcome of MM patients in both the frontline and recurrent settings. Lenalidomide is a synthetic derivative of thalidomide, which has been shown to significantly improve overall survival, time to progression, and overall response rates in patients with MM. The China Food and Drug Administration approved the use of lenalidomide in patients with MM in 2013. In a Phase II trial, lenalidomide plus low-dose dexamethasone was associated with a high response rate and acceptable safety profile in heavily pretreated Chinese patients with relapsed/refractory MM, including those with renal impairment and IgD subtype. However, lenalidomide will remain as a second-line antimyeloma drug in the near future because of its high price and the policy of health insurance reimbursement in People’s Republic of China. In this review, we summarize the clinical utility and patient considerations in the use of lenalidomide for MM in Chinese patients. Further studies with larger sample sizes are required to investigate the better quality, longer duration, and more clinically meaningful outcomes of lenalidomide in the treatment of MM in Chinese patients. Keywords: lenalidomide, multiple myeloma, clinical efficacy, Chinese patients

Safety and clinical efficacy of some radiation-sterilized medical products and pharmaceuticals

International Nuclear Information System (INIS)

Kulkarni, R.D.; Gopal, N.G.S.

1975-01-01

Medical products and pharmaceuticals must conform to certain minimum physico-chemical microbiological and biological requirements. The biological requirements comprise principally testing for toxicity, safety, and pyrogens. Besides the above-mentioned criteria, there are two other important characteristics, viz. clinical efficacy and tolerance in animal and/or human beings. These latter requirements, expected from the final product released for general human use, are not carried out routinely. In the present-day pharmaceutical and medical technology, numerous mew products are appearing, many of them requiring radiation sterilization as they are not stable towards the other conventional methods of sterilization. While the post-irradiation physicochemical changes in a product may not be significant, the bio-availability or biological activity of the product may be affected to a more significant extent. Some evidence of this has recently been reported. Hence, it is desirable to carry out studies on safety as well as clinical efficacy on irradiated products. This paper describes some studies on plastic-based medical products, a pharmaceutical raw material, a typical infusion fluid such as normal saline, antibiotics and their ointments. (author)

The development of a gender identity psychosocial clinic: treatment issues, logistical considerations, interdisciplinary cooperation, and future initiatives.

Science.gov (United States)

Leibowitz, Scott F; Spack, Norman P

2011-10-01

Few interdisciplinary treatment programs that tend to the needs of youth with gender nonconforming behaviors, expressions, and identities exist in academic medical centers with formal residency training programs. Despite this, the literature provides evidence that these youth have higher rates of poor psychosocial adjustment and suicide attempts. This article explores the logistical considerations involved in developing a specialized interdisciplinary service to these gender minority youth in accordance with the existing treatment guidelines.Demographic data will be presented and treatment issues will be explored. The impact that a specialized interdisciplinary treatment program has on clinical expansion, research development, education and training, and community outreach initiatives is discussed.

Practical considerations in the development of hemoglobin-based oxygen therapeutics.

Science.gov (United States)

Kim, Hae Won; Estep, Timothy N

2012-09-01

The development of hemoglobin based oxygen therapeutics (HBOCs) requires consideration of a number of factors. While the enabling technology derives from fundamental research on protein biochemistry and biological interactions, translation of these research insights into usable medical therapeutics demands the application of considerable technical expertise and consideration and reconciliation of a myriad of manufacturing, medical, and regulatory requirements. The HBOC development challenge is further exacerbated by the extremely high intravenous doses required for many of the indications contemplated for these products, which in turn implies an extremely high level of purity is required. This communication discusses several of the important product configuration and developmental considerations that impact the translation of fundamental research discoveries on HBOCs into usable medical therapeutics.

Practical considerations for effective microendoscopy

Science.gov (United States)

Papaioannou, Thanassis; Papazoglou, Theodore G.; Daykhovsky, Leon; Gershman, Alex; Segalowitz, Jacob; Reznik, G.; Beeder, Clain; Chandra, Mudjianto; Grundfest, Warren S.

1991-07-01

This paper reports on the application of angioscopic technology to the endoscopy of previously inaccessible body cavities. Necessary instruments including endoscopes, light sources, cameras, video recorders, monitors, and other accessories are described. Practical considerations for effective instrumentation are discussed. An overview of our clinical microendoscopic applications in more than 630 patients is presented.

Biosimilars for the management of inflammatory bowel diseases: economic considerations.

Science.gov (United States)

Gulacsi, Laszlo; Pentek, Marta; Rencz, Fanni; Brodszky, Valentin; Baji, Petra; Vegh, Zsuzsanna; Gecse, Krisztina B; Danese, Silvio; Peyrin-Biroulet, Laurent; Lakatos, Peter L

2017-04-06

Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals, due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals. The total projected cost savings are significant. If the achieved budget savings were used to cover more biological therapy, several additional IBD patients could be treated. Currently, the main barriers to the increasing uptake of biosimilars are the few incentives of the key stakeholders, while physicians' and patients' skepticism towards biosimilars seems to be changing. Over the coming years, biosimilars are expected to gain a growing importance in the treatment of IBD, contributing to a better access to treatment, improving population-level health gain and sustainability of health systems. This review summarizes the results of the literature on the economic considerations of biosimilars in IBD and the role of biosimilar infliximab in the treatment of IBD. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Electronic cigarettes: product characterisation and design considerations

OpenAIRE

Brown, Christopher J; Cheng, James M

2014-01-01

Objective To review the available evidence regarding electronic cigarette (e-cigarette) product characterisation and design features in order to understand their potential impact on individual users and on public health. Methods Systematic literature searches in 10 reference databases were conducted through October 2013. A total of 14 articles and documents and 16 patents were included in this analysis. Results Numerous disposable and reusable e-cigarette product options exist, representing w...

Considerations Regarding the Expert Systems in the Economy and the Use Method of the Production Systems Based on Rules

Directory of Open Access Journals (Sweden)

Eugenia IANCU

2010-01-01

Full Text Available As it is known, the expert systems- particularlyreferring to the ones in the economical area, represent a currentissue of our days, them being approached by all the economicalbranches. Starting from these aspects, we wish to present somenecessary principles and considerations regarding the expertsystems, representation of the facts, systems based onproduction rules. The objective of this paper is aimed toidentifying the exigencies of the production system based onrules.

Clinical Considerations in the Assessment of Adolescent Chemical Dependency.

Science.gov (United States)

Winters, Ken

1990-01-01

Discusses relevant research findings of clinical assessment of adolescent chemical dependency so that service providers can better address these concerns. Three major issues are discussed: the definition of adolescent chemical dependency, clinical domains of assessment (chemical use problem severity, precipitating and perpetuating risk factors,…

Selecting automation for the clinical chemistry laboratory.

Science.gov (United States)

Melanson, Stacy E F; Lindeman, Neal I; Jarolim, Petr

2007-07-01

Laboratory automation proposes to improve the quality and efficiency of laboratory operations, and may provide a solution to the quality demands and staff shortages faced by today's clinical laboratories. Several vendors offer automation systems in the United States, with both subtle and obvious differences. Arriving at a decision to automate, and the ensuing evaluation of available products, can be time-consuming and challenging. Although considerable discussion concerning the decision to automate has been published, relatively little attention has been paid to the process of evaluating and selecting automation systems. To outline a process for evaluating and selecting automation systems as a reference for laboratories contemplating laboratory automation. Our Clinical Chemistry Laboratory staff recently evaluated all major laboratory automation systems in the United States, with their respective chemistry and immunochemistry analyzers. Our experience is described and organized according to the selection process, the important considerations in clinical chemistry automation, decisions and implementation, and we give conclusions pertaining to this experience. Including the formation of a committee, workflow analysis, submitting a request for proposal, site visits, and making a final decision, the process of selecting chemistry automation took approximately 14 months. We outline important considerations in automation design, preanalytical processing, analyzer selection, postanalytical storage, and data management. Selecting clinical chemistry laboratory automation is a complex, time-consuming process. Laboratories considering laboratory automation may benefit from the concise overview and narrative and tabular suggestions provided.

Identifying design considerations for a shared decision aid for use at the point of outpatient clinical care: An ethnographic study at an inner city clinic.

Science.gov (United States)

Hajizadeh, Negin; Perez Figueroa, Rafael E; Uhler, Lauren M; Chiou, Erin; Perchonok, Jennifer E; Montague, Enid

2013-03-06

Computerized decision aids could facilitate shared decision-making at the point of outpatient clinical care. The objective of this study was to investigate whether a computerized shared decision aid would be feasible to implement in an inner-city clinic by evaluating the current practices in shared decision-making, clinicians' use of computers, patient and clinicians' attitudes and beliefs toward computerized decision aids, and the influence of time on shared decision-making. Qualitative data analysis of observations and semi-structured interviews with patients and clinicians at an inner-city outpatient clinic. The findings provided an exploratory look at the prevalence of shared decision-making and attitudes about health information technology and decision aids. A prominent barrier to clinicians engaging in shared decision-making was a lack of perceived patient understanding of medical information. Some patients preferred their clinicians make recommendations for them rather than engage in formal shared decision-making. Health information technology was an integral part of the clinic visit and welcomed by most clinicians and patients. Some patients expressed the desire to engage with health information technology such as viewing their medical information on the computer screen with their clinicians. All participants were receptive to the idea of a decision aid integrated within the clinic visit although some clinicians were concerned about the accuracy of prognostic estimates for complex medical problems. We identified several important considerations for the design and implementation of a computerized decision aid including opportunities to: bridge clinician-patient communication about medical information while taking into account individual patients' decision-making preferences, complement expert clinician judgment with prognostic estimates, take advantage of patient waiting times, and make tasks involved during the clinic visit more efficient. These findings

78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

Science.gov (United States)

2013-11-20

... (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical... Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft... 20852-1448. Send one self-addressed adhesive label to assist the office in processing your request. The...

78 FR 39736 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

Science.gov (United States)

2013-07-02

... collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT...-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be...-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER...

Peripheral Neuropathy – Clinical and Electrophysiological Considerations

Science.gov (United States)

Chung, Tae; Prasad, Kalpana; Lloyd, Thomas E.

2013-01-01

This article is a primer on the pathophysiology and clinical evaluation of peripheral neuropathy for the radiologist. Magnetic resonance neurography (MRN) has utility in the diagnosis of many focal peripheral nerve lesions. When combined with history, examination, electrophysiology, and laboratory data, future advancements in high-field MRN may play an increasingly important role in the evaluation of patients with peripheral neuropathy. PMID:24210312

Regulation (EC No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations

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Lehmann Birka

2008-12-01

Full Text Available Abstract Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective. The same approach may not always be applied to medicinal products used to treat children. Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions. The Regulation (EC No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children. The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD, for the European Union (EU. The CTD establishes specific provisions regarding conduct of

Measuring Clinical Productivity.

Science.gov (United States)

Hudson, Mark E; Lebovitz, Evan E

2018-06-01

Productivity measurements have been used to evaluate and compare physicians and physician practices. Anesthesiology is unique in that factors outside anesthesiologist control impact opportunity for revenue generation and make comparisons between providers and facilities challenging. This article uses data from the multicenter University of Pittsburgh Physicians Department of Anesthesiology to demonstrate factors influencing productivity opportunity by surgical facility, between department divisions and subspecialties within multispecialty divisions, and by individuals within divisions. The complexities of benchmarking anesthesiology productivity are demonstrated, and the potential value of creating a productivity profile for facilities and groups is illustrated. Copyright © 2018 Elsevier Inc. All rights reserved.

Using Digital Technologies in Clinical HIV Research: Real-World Applications and Considerations for Future Work.

Science.gov (United States)

Andriesen, Jessica; Bull, Sheana; Dietrich, Janan; Haberer, Jessica E; Van Der Pol, Barbara; Voronin, Yegor; Wall, Kristin M; Whalen, Christopher; Priddy, Frances

2017-07-31

Digital technologies, especially if used in novel ways, provide a number of potential advantages to clinical research in trials related to human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and may greatly facilitate operations as well as data collection and analysis. These technologies may even allow answering questions that are not answerable with older technologies. However, they come with a variety of potential concerns for both the participants and the trial sponsors. The exact challenges and means for alleviation depend on the technology and on the population in which it is deployed, and the rapidly changing landscape of digital technologies presents a challenge for creating future-proof guidelines for technology application. The aim of this study was to identify and summarize some common themes that are frequently encountered by researchers in this context and highlight those that should be carefully considered before making a decision to include these technologies in their research. In April 2016, the Global HIV Vaccine Enterprise surveyed the field for research groups with recent experience in novel applications of digital technologies in HIV clinical research and convened these groups for a 1-day meeting. Real-world uses of various technologies were presented and discussed by 46 attendees, most of whom were researchers involved in the design and conduct of clinical trials of biomedical HIV prevention and treatment approaches. After the meeting, a small group of organizers reviewed the presentations and feedback obtained during the meeting and categorized various lessons-learned to identify common themes. A group of 9 experts developed a draft summary of the findings that was circulated via email to all 46 attendees for review. Taking into account the feedback received, the group finalized the considerations that are presented here. Meeting presenters and attendees discussed the many successful applications of digital

Acceleration of cardiovascular MRI using parallel imaging: basic principles, practical considerations, clinical applications and future directions

International Nuclear Information System (INIS)

Niendorf, T.; Sodickson, D.

2006-01-01

Cardiovascular Magnetic Resonance (CVMR) imaging has proven to be of clinical value for non-invasive diagnostic imaging of cardiovascular diseases. CVMR requires rapid imaging; however, the speed of conventional MRI is fundamentally limited due to its sequential approach to image acquisition, in which data points are collected one after the other in the presence of sequentially-applied magnetic field gradients and radiofrequency coils to acquire multiple data points simultaneously, and thereby to increase imaging speed and efficiency beyond the limits of purely gradient-based approaches. The resulting improvements in imaging speed can be used in various ways, including shortening long examinations, improving spatial resolution and anatomic coverage, improving temporal resolution, enhancing image quality, overcoming physiological constraints, detecting and correcting for physiologic motion, and streamlining work flow. Examples of these strategies will be provided in this review, after some of the fundamentals of parallel imaging methods now in use for cardiovascular MRI are outlined. The emphasis will rest upon basic principles and clinical state-of-the art cardiovascular MRI applications. In addition, practical aspects such as signal-to-noise ratio considerations, tailored parallel imaging protocols and potential artifacts will be discussed, and current trends and future directions will be explored. (orig.)

CONSIDERATIONS FOR THE MASS AND ENERGY INTEGRATION IN THE SUGAR PROCESS PRODUCTION AND DERIVATIVE PROCESS

Directory of Open Access Journals (Sweden)

Dennis Abel Clavelo Sierra

2015-04-01

Full Text Available The current society needs now more than ever of industries that create new forms and methods where the saving of energy and materials is a fundamental aspect. For this reason, in the present investigation we present an outline with the considerations for the integration of the processes of sugar and other derived products, in an outline of bio refinery with the objective of achieving efficient processes with an appropriate use of the material resources and an efficient use of the energy, with minimum operation costs and investment. In the outline we take as base for the study, it is considered that the integrated complex has as basic input the sugarcane; it is also considered the variation of the prices of the products in the market. In the article we make an outline with the precise steps for the development of a methodology that allows analyzing the processes involved in the biorefinery outline and in this way to identify the common material and energy resources that the processes exchange. A heuristic diagram is presented that guides the strategy to continue for it.

APPLICATION OF PROBIOTIC PRODUCT CONTAINING LACTOBACILLUS CASEI IMUNITASS IN CLINICAL PRACTICE

Directory of Open Access Journals (Sweden)

D.V. Usenko

2007-01-01

Full Text Available This article includes an overview of clinical research that study the efficiency of including into children's ration sour milk proc biotic product actimel (Danone, France, created on the basis of milk fermented with Lactobacillus bulgaricus and Streptococcus thermophilus, and enriched with culture of Lactobacillus casei DNC 114001 (commercial name L. casei imunitass.Key words: probiotic product, children, Lactobacillus casei DN 114001.

Clinical trials in "emerging markets": regulatory considerations and other factors.

Science.gov (United States)

Singh, Romi; Wang, Ouhong

2013-11-01

Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity.

Science.gov (United States)

Degrazio, Fran L

2018-01-01

A new major chapter dealing with container closure integrity was released by the United States Pharmacopeial Convention. Chapter provides a significant amount of education and guidance concerning test methodologies to prove that a system is integral and safe for use. The test method used is only one of the major considerations in approaching the challenge of proving an integral system. This paper takes a holistic review of all the major considerations needed in qualifying a new vial system for container closure integrity. There is substantial interplay among many aspects in the process of sealing a vial. This review helps to define major risks that need to be considered and mitigated and reinforces the need to understand the maximum allowable leakage limit that is acceptable for a specific drug application. A typical risk-based approach considers materials, test methods, process, people, environment, and equipment. Each of these aspects is considered in some detail along with a recommended process flow for building a best practice, science-based approach. This approach will inform decision making for evaluating the correct combination of components and assuring they are assembled and tested in an appropriate manner. This work, once completed, can be the basis for a vial system platform or specific drug application qualification. LAY ABSTRACT: Container closure integrity is a fundamental requirement of every sterile drug package. With recent upgrading of compendia standards and guidance around this issue, there is an opportunity to better define a best practice approach to a complicated subject. It is important to recognize that there is substantial interplay among the components of the system, the process of assembly, and the test methods that are used. This paper takes a holistic approach to discussing these issues and identifying the risks that must be considered in assuring an integral container over the shelf life of a drug product. © PDA, Inc. 2018.

Clinical application of removable partial dentures using thermoplastic resin. Part II: Material properties and clinical features of non-metal clasp dentures.

Science.gov (United States)

Fueki, Kenji; Ohkubo, Chikahiro; Yatabe, Masaru; Arakawa, Ichiro; Arita, Masahiro; Ino, Satoshi; Kanamori, Toshikazu; Kawai, Yasuhiko; Kawara, Misao; Komiyama, Osamu; Suzuki, Tetsuya; Nagata, Kazuhiro; Hosoki, Maki; Masumi, Shin-ichi; Yamauchi, Mutsuo; Aita, Hideki; Ono, Takahiro; Kondo, Hisatomo; Tamaki, Katsushi; Matsuka, Yoshizo; Tsukasaki, Hiroaki; Fujisawa, Masanori; Baba, Kazuyoshi; Koyano, Kiyoshi; Yatani, Hirofumi

2014-04-01

This position paper reviews physical and mechanical properties of thermoplastic resin used for non-metal clasp dentures, and describes feature of each thermoplastic resin in clinical application of non-metal clasp dentures and complications based on clinical experience of expert panels. Since products of thermoplastic resin have great variability in physical and mechanical properties, clinicians should utilize them with careful consideration of the specific properties of each product. In general, thermoplastic resin has lower color-stability and higher risk for fracture than polymethyl methacrylate. Additionally, the surface of thermoplastic resin becomes roughened more easily than polymethyl methacrylate. Studies related to material properties of thermoplastic resin, treatment efficacy and follow-up are insufficient to provide definitive conclusions at this time. Therefore, this position paper should be revised based on future studies and a clinical guideline should be provided. Copyright © 2014 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

Ethical considerations of therapeutic hypnosis and children.

Science.gov (United States)

Etzrodt, Christine M

2013-04-01

Historically, therapeutic hypnosis has been met with skepticism within some fields, although acceptance has expanded in recent decades. Development and application of ethical standards and principles has contributed to increased acceptance of hypnosis with children. The Ethics Code of the American Psychological Association (APA, 2002) and the Code of Conduct of the American Society of Clinical Hypnosis (ASCH, 2000) serve as guides to ethical considerations when treating children. From a developmental and practical perspective, children have limited decision-making capacities, therefore special attention should be paid to their rights and welfare. Important ethical considerations relevant to children and hypnosis have emerged, including competence, supervision, informed consent, confidentiality, and boundaries. Considerations are reviewed from a normal and abnormal child development perspective.

Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials.

Science.gov (United States)

Hanna, Eve; Rémuzat, Cecile; Auquier, Pascal; Toumi, Mondher

2016-01-01

Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources. Our objective is to identify the number and characteristics of discontinued ATMPs trials in order to evaluate the rate of discontinuation. We searched for ATMPs trials conducted between 1999 to June 2015 using three databases, which are Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the EU Drug Regulating Authorities Clinical Trials (EudraCT). We selected the ATMPs trials after elimination of the duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organizations. We classified ATMPs by type and trial status, that is, ongoing, completed, terminated, discontinued, and prematurely ended. Then, we calculated the rate of discontinuation. Between 1999 and June 2015, 143 withdrawn, terminated, or prematurely ended ATMPs clinical trials were identified. Between 1999 and June 2013, 474 ongoing and completed clinical trials were identified. Therefore, the rate of discontinuation of ATMPs trials is 23.18%, similar to that for non-ATMPs drugs in development. The probability of discontinuation is, respectively, 27.35, 16.28, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (43%), followed by cardiology (19.2%). It is almost the same for commercial and non-commercial sponsors; therefore, the discontinuation reason may not be financially driven. No failure risk rate per development phase is available for ATMPs. The discontinuation rate may prove helpful when assessing the

44 CFR 331.4 - Special consideration.

Science.gov (United States)

2010-10-01

... HOMELAND SECURITY PREPAREDNESS PRESERVATION OF THE MOBILIZATION BASE THROUGH THE PLACEMENT OF PROCUREMENT... sells a significant proportion of its production to the Government is generally depressed or has a... hearing of interested parties, will give consideration to appropriate measures applicable to the entire...

15 CFR 1160.4 - Antitrust considerations.

Science.gov (United States)

2010-01-01

... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Antitrust considerations. 1160.4 Section 1160.4 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) TECHNOLOGY ADMINISTRATION, DEPARTMENT OF COMMERCE PRODUCTIVITY, TECHNOLOGY AND INNOVATION Promotion of...

The clinical and radiologic consideration of cementifying and ossifying fibroma of the jaws

International Nuclear Information System (INIS)

Jo, Eun Young; Kim, Kee Deog; Park, Chang Seo

1997-01-01

The purpose of this study was to know the proper diagnosis and to establish the treatment plan of cementifying and ossifying fibroma in the jaws through the clinical, radiological, and histopathologic considerations. The authors compared and analyzed the clinicoradiologic features of the thirteen cases of cementifying and ossifying fibroma, diagnosed at the Dental college hospital in Yonsei university, Seoul, Korea, during the period from 1980 to 1995. The obtained results were as follows : 1. Cementifying and ossifying fibroma occurred in the mean age, 44 years, ranged from 29 to 65 years and the male to female ratio was approximately 1:5. 2. Swelling was the most common frequent presenting complaints. Other reported symptoms included pain, tooth mobility and symptom. 3. The frequency of the lesions was twelve cases in the mandible and one case in the maxilla. And eleven of thirteen cases were distributed on the premolar and molar region. 4. Radiologically, eight of thirteen cases were well defined lesions, five cases were relatively well defined lesions. And nine of thirteen cases were mixed lesions, three cases were radiopaque lesions, and only one case was purely radiolucent lesion. 5. Histologically, seven of thirteen cases were classified ossifying fibroma, four cases were cemento-ossifying fibroma, and two cases were cementifying fibroma.

Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

Science.gov (United States)

Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

2010-01-01

The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

Science.gov (United States)

2010-08-06

...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of... product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and...

Establishing guidelines for CAR-T cells: challenges and considerations.

Science.gov (United States)

Wang, Wei; Qin, Di-Yuan; Zhang, Bing-Lan; Wei, Wei; Wang, Yong-Sheng; Wei, Yu-Quan

2016-04-01

T cells, genetically modified by chimeric antigen receptors (CAR-T), are endowed with specificity to a desired antigen and are cytotoxic to cells expressing the targeted antigen. CAR-T-based cancer immunotherapy is a promising therapy for curing hematological malignancy, such as acute lymphoid leukemia, and is promising for extending their efficacy to defeat solid tumors. To date, dozens of different CAR-T cells have been evaluated in clinical trials to treat tumors; this necessitates the establishment of guidelines for the production and application of CAR-T cells. However, it is challenging to standardize CAR-T cancer therapy because it involves a combination of gene therapy and cell therapy. In this review, we compare the existing guidelines for CAR-T cells and discuss the challenges and considerations for establishing guidance for CAR-T-based cancer immunotherapy.

Adoptable Interventions, Human Health, and Food Safety Considerations for Reducing Sodium Content of Processed Food Products

Science.gov (United States)

Allison, Abimbola; Fouladkhah, Aliyar

2018-01-01

Although vital for maintaining health when consumed in moderation, various epidemiological studies in recent years have shown a strong association between excess dietary sodium with an array of health complications. These associations are robust and clinically significant for development of hypertension and prehypertension, two of the leading causes of preventable mortality worldwide, in adults with a high-sodium diet. Data from developed nations and transition economies show worldwide sodium intake of higher than recommended amounts in various nations. While natural foods typically contain a moderate amount of sodium, manufactured food products are the main contributor to dietary sodium intake, up to 75% of sodium in diet of American adults, as an example. Lower cost in formulation, positive effects on organoleptic properties of food products, effects on food quality during shelf-life, and microbiological food safety, make sodium chloride a notable candidate and an indispensable part of formulation of various products. Although low-sodium formulation of each product possesses a unique set of challenges, review of literature shows an abundance of successful experiences for products of many categories. The current study discusses adoptable interventions for product development and reformulation of products to achieve a modest amount of final sodium content while maintaining taste, quality, shelf-stability, and microbiological food safety. PMID:29389843

Adoptable Interventions, Human Health, and Food Safety Considerations for Reducing Sodium Content of Processed Food Products.

Science.gov (United States)

Allison, Abimbola; Fouladkhah, Aliyar

2018-02-01

Although vital for maintaining health when consumed in moderation, various epidemiological studies in recent years have shown a strong association between excess dietary sodium with an array of health complications. These associations are robust and clinically significant for development of hypertension and prehypertension, two of the leading causes of preventable mortality worldwide, in adults with a high-sodium diet. Data from developed nations and transition economies show worldwide sodium intake of higher than recommended amounts in various nations. While natural foods typically contain a moderate amount of sodium, manufactured food products are the main contributor to dietary sodium intake, up to 75% of sodium in diet of American adults, as an example. Lower cost in formulation, positive effects on organoleptic properties of food products, effects on food quality during shelf-life, and microbiological food safety, make sodium chloride a notable candidate and an indispensable part of formulation of various products. Although low-sodium formulation of each product possesses a unique set of challenges, review of literature shows an abundance of successful experiences for products of many categories. The current study discusses adoptable interventions for product development and reformulation of products to achieve a modest amount of final sodium content while maintaining taste, quality, shelf-stability, and microbiological food safety.

METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS

Directory of Open Access Journals (Sweden)

V. B. Ivanov

2017-01-01

Full Text Available The article considers the experience of Russian and leading foreign regulatory agencies in organisation and conduction of preclinical and clinical trials of human immunoglobulin products. The authors suggest a classification of human immunoglobulins and provide updated information on authorization of these products in Russia. The article summarizes methodological approaches, basic scientific principles and criteria relating to expert evaluation of preclinical and clinical trials of blood products. The authors further define the expert body’s requirements for data on preclinical and clinical trials of human normal immuniglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases which are submitted as part of applications for marketing authorization or marketing authorization variation. The article suggests programs of preclinical and clinical trials for human normal immunoglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases that are aligned with the Russian legislation and Eurasian Economic Union’s regulations on medicines circulation, and have been elaborated with respect to the guidelines of the European Medicines Agency.

Enzymatic biodiesel production: Technical and economical considerations

DEFF Research Database (Denmark)

Munk Nielsen, Per; Brask, Jesper; Fjerbæk, Lene

2008-01-01

It is well documented in the literature that enzymatic processing of oils and fats for biodiesel is technically feasible. However, with very few exceptions, enzyme technology is not currently used in commercial-scale biodiesel production. This is mainly due to non-optimized process design...... and a lack of available costeffective enzymes. The technology to re-use enzymes has typically proven insufficient for the processes to be competitive. However, literature data documenting the productivity of enzymatic biodiesel together with the development of new immobilization technology indicates...... that enzyme catalysts can become cost effective compared to chemical processing. This work reviews the enzymatic processing of oils and fats into biodiesel with focus on process design and economy....

Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing.

Science.gov (United States)

Lester, Sally; Harr, K E; Rishniw, Mark; Pion, Paul

2013-01-15

Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research

NARCIS (Netherlands)

De Vos, FJ; De Decker, M; Dierckx, RA

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice

Clinical neuropsychiatric considerations regarding nonsubstance or behavioral addictions

Science.gov (United States)

Potenza, Marc N.

2017-01-01

Over the past several decades, non-substance-use behaviors like gambling, gaming, and sex have received greater consideration as possible foci of addictions. In this article, I will review the recent history and current status of non-substance or behavioral addictions. A main focus will involve gambling and gambling disorder, given that the latter is currently the sole non-substance addictive disorder described in the main text of the current (fifth) edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Internet gaming disorder, currently in the DSM-5 section addressing conditions that may need additional research, will also be considered, as will the concept of Internet addiction. Compulsive sexual behaviors (including problematic pornography use) will be considered, particularly with respect to how behavioral addictions may be considered in the forthcoming 11th edition of the International Classification of Diseases (ICD-11). PMID:29302225

The forearm complex: anatomy, biomechanics and clinical considerations.

Science.gov (United States)

LaStayo, Paul C; Lee, Michael J

2006-01-01

The forearm complex is comprised of the proximal radioulnar joint, middle radioulnar joint/interosseous membrane, and the distal radioulnar joint. These three areas function in a coordinated manner to rotate the hand in space and allow performance of functional tasks. If a structure or structures in one of these three areas is disrupted, this can adversely affect the function at any of the other two remaining areas. Surgical intervention focuses on restoring anatomical alignment to preserve the function of the forearm complex. Rehabilitation is guided by the relationships between the three areas of the forearm complex and the awareness of clinical signs, symptoms, and complications. The purposes of this paper are to 1) describe the anatomy and biomechanical function of the forearm complex and 2) discuss clinical correlates pertaining to select forearm injuries (excluding peripheral nerve injuries) that may affect forearm function.

Tissue engineered constructs: perspectives on clinical translation.

Science.gov (United States)

Lu, Lichun; Arbit, Harvey M; Herrick, James L; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J

2015-03-01

In this article, a "bedside to bench and back" approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the U.S. Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or new drug application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented.

Clinical consideration of thrombocytopenia in children

Directory of Open Access Journals (Sweden)

S. Ratna Laksmiastuti

2010-12-01

Full Text Available Background: Pediatric patient with the history of bleeding disorder as thrombocytopenia is considered as a clinical case in dentistry. The patient with platelet count below normal has potential risk of bleeding disorders. The situation would be more dangerous if the dentist could not identify the problem. Purpose: The aim of this review is to describe how a dentist must understand the step and management that should be performed in pediatric patient with history of bleeding disorder due to thrombocytopenia. Reviews: Bleeding disorders might be the result of thrombocytopenia, a condition that alter the ability of blood vessels, platelet and coagulation factors in normal hemostatic system. Thrombocytopenia is defined as a platelet count of less than normal (150.000/mm3–400.000/mm3. Etiology, risk factor and preventive method of thrombocytophenia are still unknown. Conclusion: It is concluded that special attention is needed for pediatric patient with thrombocytopenia. A dentist should understand well about this disorder on how to take the history, to do clinical examination, to establish the diagnosis and to decide treatment plan as well as to consult to related collongues.Latar belakang: Penderita anak-anak dengan riwayat gangguan perdarahan yang ditandai dengan adanya trombositopenia merupakan masalah klinis yang ditemukan dalam bidang kedokteran gigi. Beberapa perawatan di bidang kedokteran gigi beresiko menimbulkan terjadinya perdarahan. Keadaan akan berbahaya bila dokter gigi tidak dapat mengidentifikasi masalah. Tujuan: Artikel ini menunjukkan pentingnya seorang dokter gigi memahami dan mengetahui langkah dan tindakan apa yang harus dilakukan, bila suatu saat menghadapi penderita anak-anak dengan riwayat gangguan perdarahan akibat trombositopenia. Review: Gangguan perdarahan adalah suatu kondisi terjadinya penurunan kemampuan dari pembuluh darah, platelet, dan faktor pembekuan pada fungsi normal hemostasis. Trombositopenia adalah jumlah

Enamel microabrasion: An overview of clinical and scientific considerations

Science.gov (United States)

Pini, Núbia Inocencya Pavesi; Sundfeld-Neto, Daniel; Aguiar, Flavio Henrique Baggio; Sundfeld, Renato Herman; Martins, Luis Roberto Marcondes; Lovadino, José Roberto; Lima, Débora Alves Nunes Leite

2015-01-01

Superficial stains and irregularities of the enamel are generally what prompt patients to seek dental intervention to improve their smile. These stains or defects may be due to hypoplasia, amelogenesis imperfecta, mineralized white spots, or fluorosis, for which enamel microabrasion is primarily indicated. Enamel microabrasion involves the use of acidic and abrasive agents, such as with 37% phosphoric acid and pumice or 6% hydrochloric acid and silica, applied to the altered enamel surface with mechanical pressure from a rubber cup coupled to a rotatory mandrel of a low-rotation micromotor. If necessary, this treatment can be safely combined with bleaching for better esthetic results. Recent studies show that microabrasion is a conservative treatment when the enamel wear is minimal and clinically imperceptible. The most important factor contributing to the success of enamel microabrasion is the depth of the defect, as deeper, opaque stains, such as those resulting from hypoplasia, cannot be resolved with microabrasion, and require a restorative approach. Surface enamel alterations that result from microabrasion, such as roughness and microhardness, are easily restored by saliva. Clinical studies support the efficacy and longevity of this safe and minimally invasive treatment. The present article presents the clinical and scientific aspects concerning the microabrasion technique, and discusses the indications for and effects of the treatment, including recent works describing microscopic and clinical evaluations. PMID:25610848

Expanding Clinical Laboratory Tobacco Product Evaluation Methods to Loose-leaf Tobacco Vaporizers

Science.gov (United States)

Lopez, Alexa A.; Hiler, Marzena; Maloney, Sarah; Eissenberg, Thomas; Breland, Alison

2016-01-01

Background Novel tobacco products entering the US market include electronic cigarettes (ECIGs) and products advertised to “heat, not burn” tobacco. There is a growing literature regarding the acute effects of ECIGs. Less is known about “heat, not burn” products. This study’s purpose was to expand existing clinical laboratory methods to examine, in cigarette smokers, the acute effects of a “heat, not burn” “loose-leaf tobacco vaporizer” (LLTV). Methods Plasma nicotine and breath carbon monoxide (CO) concentration and tobacco abstinence symptom severity were measured before and after two 10-puff (30-sec interpuff interval) product use bouts separated by 60 minutes. LLTV effects were compared to participants’ own brand (OB) cigarettes and an ECIG (3.3 V; 1.5 Ohm; 18 mg/ml nicotine). Results Relative to OB, LLTV increased plasma nicotine concentration to a lesser degree, did not increase CO, and appeared to not reduce abstinence symptoms as effectively. Relative to ECIG, LLTV nicotine and CO delivery and abstinence symptom suppression did not differ. Participants reported that both the LLTV and ECIG were significantly less satisfying than OB. Conclusions Results demonstrate that LLTVs are capable of delivering nicotine and suppressing tobacco abstinence symptoms partially; acute effects of these products can be evaluated using existing clinical laboratory methods. Results can inform tobacco product regulation and may be predictive of the extent that these products have the potential to benefit or harm overall public health. PMID:27768968

Chemical considerations in severe accident analysis

International Nuclear Information System (INIS)

Malinauskas, A.P.; Kress, T.S.

1988-01-01

The Reactor Safety Study presented the first systematic attempt to include fission product physicochemical effects in the determination of expected consequences of hypothetical nuclear reactor power plant accidents. At the time, however, the data base was sparse, and the treatment of fission product behavior was not entirely consistent or accurate. Considerable research has since been performed to identify and understand chemical phenomena that can occur in the course of a nuclear reactor accident, and how these phenomena affect fission product behavior. In this report, the current status of our understanding of the chemistry of fission products in severe core damage accidents is summarized and contrasted with that of the Reactor Safety Study

Impact of risk considerations on dosimetry of radiopharmaceuticals

International Nuclear Information System (INIS)

Eckerman, K.F.

1981-01-01

Estimates of the absorbed dose from clinical procedures involving the administration of radiopharmaceuticals are used primarily to determine the presumed risk of various procedures so that, in-so-far as possible, the selection of a given procedure can be based on a comparison of risk. Although this has been the basic objective, risk evaluation has generally been separated from the dosimetry considerations. In the recent revision of its radiation protection guidance, the International Commission on Radiological Protection (ICRP) has embodied risk considerations in its recommendations and risk concepts have become an integral part of the dosimetric framework. The impact of these considerations on the dosimetric assessments of radiopharmaceuticals and the resulting need for additional information is discussed

Writing about Clients: Ethical Considerations and Options

Science.gov (United States)

Sperry, Len; Pies, Ronald

2010-01-01

Today, the decision to prepare clinical case material for publication is a decision that cannot be taken lightly. The decision involves reviewing ethical considerations and choosing among various options to safeguard client privacy. Such options include seeking the client's permission, disguising case material, and developing composite case…

Diagnostic Consideration for Sinonasal Wegener's Granulomatosis Clinically Mistaken for Carcinoma

Science.gov (United States)

La Rosa, Cristina; Emmanuele, Carmela; Tranchina, Maria Grazia; Ippolito, Massimo; Cosentino, Sebastiano; Saita, Vincenzo; Fraggetta, Filippo

2013-01-01

We report a case of Wegener's granulomatosis clinically mistaken for carcinoma in a 21-year-old girl presenting with an ulcerated mass of the nasopharynx associated with enlarged laterocervical nodes. The lesion was clinically suspected as malignant on the basis of clinical and radiological findings (namely, computed tomography scan and positron emission tomography). However, multiple biopsies were not conclusive for malignancy showing histological change suggestive of Wegener's granulomatosis. A serum determination of cANCA supported the diagnosis of Wegener's granulomatosis. Clinical findings and image studies suggested an erroneous diagnosis of malignancy whereas a definitive diagnosis of Wegener's granulomatosis was achieved only after repeated biopsies thus leading to a correct therapeutic approach. The Wegener granulomatosis must be added to the list of the differential diagnoses of the masses of the nasopharynx associated with or without enlarged laterocervical nodes. PMID:24106630

Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

Science.gov (United States)

Boráň, Tomáš; Menezes-Ferreira, Margarida; Reischl, Ilona; Celis, Patrick; Ferry, Nicolas; Gänsbacher, Bernd; Krafft, Hartmut; Lipucci di Paola, Michele; Sladowski, Dariusz; Salmikangas, Paula

2017-09-01

The research and development of advanced therapy medicinal products (ATMPs) has been active in Europe and worldwide during recent years. Yet, the number of licensed products remains low. The main expected legal change in the near future in the European Union (EU) concerns the regulation on clinical trials (536/2014), which will come into force in 2018. With this new framework, a more harmonized and swift process for approval of clinical trials is anticipated, which is expected to support the entry of new innovations into the EU market. A survey on ATMPs in clinical trials during 2010-2015 in the EU was conducted in order to study the trends of ATMP development since the earlier survey published in 2012. According to the results, the number of clinical trials using ATMPs is slowly increasing in the EU. Yet, the focus is still in early development, and the projects are mainly carried out by small and medium-sized enterprises, academia, and hospitals. Oncology is the main area of clinical development. Yet, the balance between cell-based products and gene therapy medicinal products in this area may be changing in the future due to the new T-cell technologies. Many limitations and challenges are identified for ATMP development, requiring proportionate regulatory requirements. On the other hand, for such a novel field, the developers should be active in considering possible constraints and actively engage with authorities to look for solutions. This article provides up to-date information on forthcoming regulatory improvements and discusses the main challenges hampering the commercialization of ATMPs in the EU.

Kinetic and economic considerations of biogas production systems

Energy Technology Data Exchange (ETDEWEB)

Bala, B K; Satter, M A [Bangladesh Agricultural Univ., Mymensingh (BD). Dept. of Farm Power and Machinery

1990-01-01

In this paper, the kinetics and economics of substrate degradation and biogas production are discussed. Mass balance on substrate, with either the Contois or Adams-Eckenfelder models, is used to design the mathematical models of volatile solids reduction and biogas fermentation. The predictions of both the models are found to be in close agreement with the observed values reported. A computer model based on a system dynamics approach is used to model the economics of biogas production by anaerobic digestion from cattle slurry available from typical rural families in Bangladesh. This model incorporates the Adams-Eckenfelder model to determine the amount of gas production and the technique described by Audsley and Wheeler to take into account the effects of price, interest, and inflation. The effects of changes of these parameters on the net profit or loss from the process are also considered. (author).

Safety and effectiveness considerations for clinical studies of visual prosthetic devices

Science.gov (United States)

Cohen, Ethan D.

2007-03-01

With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.

Alternative Blood Products and Clinical Needs in Transfusion Medicine

OpenAIRE

Whitsett, Carolyn; Vaglio, Stefania; Grazzini, Giuliano

2012-01-01

The primary focus of national blood programs is the provision of a safe and adequate blood supply. This goal is dependent on regular voluntary donations and a regulatory infrastructure that establishes and enforces standards for blood safety. Progress in ex vivo expansion of blood cells from cell sources including peripheral blood, cord blood, induced pluripotent stem cells, and human embryonic stem cell lines will likely make alternative transfusion products available for clinical use in the...

Technical note - Considerations for MR imaging of small animals

International Nuclear Information System (INIS)

Baker, Martin A.

2011-01-01

Routine clinical veterinary use of MR scanning is becoming more common. This article addresses the major technical considerations for radiographers performing MR examinations on small animals and provides practical advice for scanning techniques.

Productivity considerations for shovels and excavators

Energy Technology Data Exchange (ETDEWEB)

Fiscor, S.

2007-09-15

During Haulage and Loading 2007, the Engineering and Mining Journal organized an OEM round table discussion with the theme 'Reducing cycle times'. Seven panelists identified areas where they could improve cycle times for open-pit mining. Although the discussions focused mainly on haud trucks, two panelists discussed shovel productivity as it relates to cycle times. Topics ranged from truck-shovel pass matching to payload management. A clear message came through that all the minutes saved per cycle meant nothing if the mine did not have a properly trained operator. The article reports on the discussions. 4 figs.

A marketing clinical doctorate programs.

Science.gov (United States)

Montoya, Isaac D; Kimball, Olive M

2007-01-01

Over the past decade, clinical doctorate programs in health disciplines have proliferated amid both support and controversy among educators, professional organizations, practitioners, administrators, and third-party payers. Supporters argue that the explosion of new knowledge and increasing sophistication of technology have created a need for advanced practice models to enhance patient care and safety and to reduce costs. Critics argue that necessary technological advances can be incorporated into existing programs and believe that clinical doctorates will increase health care costs, not reduce them. Despite the controversy, many health disciplines have advanced the clinical doctorate (the most recent is the doctor of nursing practice in 2004), with some professions mandating the doctorate as the entry-level degree (i.e., psychology, pharmacy, audiology, and so on). One aspect of the introduction of clinical doctoral degrees has been largely overlooked, and that is the marketing aspect. Because of marketing considerations, some clinical doctorates have been more successfully implemented and accepted than others. Marketing is composed of variables commonly known as "the four P's of marketing": product, price, promotion, and place. This report explores these four P's within the context of clinical doctorates in the health disciplines.

Clinical evidence for orphan medicinal products-a cause for concern?

Science.gov (United States)

Picavet, Eline; Cassiman, David; Hollak, Carla E; Maertens, Johan A; Simoens, Steven

2013-10-16

The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at the time of marketing authorization, are too low. Therefore, the aim of this study was to quantitatively evaluate the characteristics and quality of clinical evidence that is presented for OMPs to obtain marketing authorization in Europe, using the new and validated COMPASS tool. We quantitatively assessed the characteristics and quality of clinical evidence of the pivotal studies of 64 OMPs as described in the European Public Assessment Report and/or the Scientific Discussion document prepared by the Committee for Human Medicinal Products of the EMA. The 64 OMPs were altogether authorized for 78 orphan indications, for which 117 studies were identified as 'pivotal' or 'main' studies. In approximately two thirds of the studies, the allocation was randomized (64.8%) and a control arm was used (68.5%). Half of the studies applied some type of blinding. Only a minority (26.9%) of the studies included a Quality-of-Life (QoL) related endpoint, of which a third claim an improvement in QoL. Upon analyzing the quality of reporting, we found that some aspects (i.e. the endpoints, the sampling criteria, and the interventions) are well described, whereas other items (i.e. a description of the patients and of potential biases) are not reported for all studies. In conclusion, the pivotal studies that are the basis for marketing authorization of OMPs are a cause for concern, as they exhibit methodological flaws i.e. the lack of QoL-related endpoints as outcome, lack of blinding in the study design and the use of surrogate endpoints. Additionally, there are shortcomings in the reporting of those studies that complicate the interpretation. A more demanding regulatory process for OMPs is

Engaged or exhausted—How does it affect dentists’ clinical productivity?

Directory of Open Access Journals (Sweden)

Jari J. Hakanen

2014-06-01

Full Text Available This cross-sectional study examines whether job burnout (exhaustion and work engagement are associated with the clinical productivity of dentists measured by the amount of paid procedure fees in a single month. We conducted an OLS regression analyses of data on dentists working at municipal health centers in Finland (N = 269; response rate 37%. The results indicated that work engagement was positively associated with the amount of procedure fees and consequently with dentists’ pay level after several work-related and demographic background variables were controlled for. However, exhaustion was not related to productivity after controlling for the impact of other factors.

A consideration of the operation of automatic production machines.

Science.gov (United States)

Hoshi, Toshiro; Sugimoto, Noboru

2015-01-01

At worksites, various automatic production machines are in use to release workers from muscular labor or labor in the detrimental environment. On the other hand, a large number of industrial accidents have been caused by automatic production machines. In view of this, this paper considers the operation of automatic production machines from the viewpoint of accident prevention, and points out two types of machine operation - operation for which quick performance is required (operation that is not permitted to be delayed) - and operation for which composed performance is required (operation that is not permitted to be performed in haste). These operations are distinguished by operation buttons of suitable colors and shapes. This paper shows that these characteristics are evaluated as "asymmetric on the time-axis". Here, in order for workers to accept the risk of automatic production machines, it is preconditioned in general that harm should be sufficiently small or avoidance of harm is easy. In this connection, this paper shows the possibility of facilitating the acceptance of the risk of automatic production machines by enhancing the asymmetric on the time-axis.

Rectal drug administration: clinical pharmacokinetic considerations.

Science.gov (United States)

de Boer, A G; Moolenaar, F; de Leede, L G; Breimer, D D

1982-01-01

The human rectum represents a body cavity in which drugs can be easily introduced and retained and from which absorption is well possible. There are important therapeutic reasons why it is sometimes preferable to give a drug rectally rather than orally, e.g. in cases of nausea and vomiting. Drawbacks of rectal drug administration include the interruption of absorption by defaecation and lack of patient acceptability. The mechanism of drug absorption from the rectum is probably no different to that in the upper part of the gastrointestinal tract, despite the fact that the physiological circumstances (e.g. pH, fluid content) differ substantially, Absorption from aqueous and alcoholic solutions may occur very rapidly, which has proved to be of considerable therapeutic value in the rapid suppression of acute convulsive attacks by diazepam (e.g. in children), but absorption from suppositories is generally slower and very much dependent on the nature of the suppository base, the use of surfactants or other additives, particle size of the active ingredient, etc. There is some evidence that hepatic first-pass elimination of high clearance drugs is partially avoided after rectal administration, e.g. lignocaine. This can be explained by the rectal venous blood supply: the upper part is connected with the portal system, whereas the lower part is directly connected with the systemic circulation. Plasma concentration data following rectal administration of representatives of several classes of drugs are reviewed: anticonvulsants, non-narcotic analgesics and non-steroidal anti-inflammatory agents, hypnosedatives and anaesthetics, strong analgesics, theophylline and derivatives, corticosteroids, antibacterial agents, thiazinamium, promethazine, hyoscine-N-butyl-bromide, streptokinase, progesterone, ergotamine tartrate and levodopa. Only limited number of cases has it been adequately shown that the rectal route of administration gives plasma concentrations which are comparable to

Effect of Physical Therapy Students' Clinical Experiences on Clinician Productivity.

Science.gov (United States)

Pivko, Susan E; Abbruzzese, Laurel D; Duttaroy, Pragati; Hansen, Ruth L; Ryans, Kathryn

2016-01-01

Physical therapy clinical education experiences (CEEs) are difficult to secure, particularly first-level CEEs. Our purpose was to determine 1) what impact student full-time CEEs have on PT clinician productivity and 2) whether there is a productivity difference between first vs final CEEs. Productivity logs, including possible factors impacting productivity, were distributed to clinician-student pairings on first and final CEEs. Two-week baseline data (without a student) were compared to weeks 1 and 6 (with a student) for 31 logs using a 2x4 repeated-measures ANOVA. In a subset of 17 logs for CEEs 8 weeks or longer, a 2x5 repeated-measures ANOVA was performed. There was a significant increase in the number of patients seen and CPT units billed by both levels of CEEs comparing weeks 1 and 6. In the subset of CEEs, 8 weeks or longer, there was a significant increase in the number of patients treated per hour at week 6 and a trend toward a change at week 8 when compared to baseline week A. The factors selected as impacting productivity were census (59%) and staffing (32%). Physical therapy clinician-student pairings showed an overall increase in productivity during both full-time first and final level CEEs.

CLINICAL AND PHYSIOLOGICAL EVALUATION OF SPECIALIZED FOOD PRODUCT FOR PREGNANT WOMEN

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I. V. Salimova

2012-01-01

Full Text Available We have evaluated specialized product «Celia Mama» for pregnant women nutrition. 15 women on 31–32 week of pregnancy took part in the study. The duration of the product intake was 6,5 ± 1,5 wk. Tolerability was evaluated according to a personal attitude towards it and impartial clinical parameters such as — skin and mucosa condition, presence of allergy, presence or worsening of gastrointestinal dysfunction (heartburn, flatulence, stomach ache, stools (amount, consistency, digestibility, pathological inclusions, colour, smell. It has been shown that this product possesses adequate organoleptic qualities and is well tolerated by pregnant women. This product has passed hygienic expertise in our Scientific Research Centre and judging upon results of our study we can conclude that it can be used as a food supplement for pregnant women..

On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices (GCPs).

Science.gov (United States)

Méthot, Julie; Brisson, Diane; Gaudet, Daniel

2012-04-01

Investigators and research teams participating in clinical trials have to deal with complex investigational products, study designs, and research environments. The emergence of new drug delivery systems and investigational products combining more than one drug and the development of biodrugs such as monoclonal antibodies, peptides, siRNA, and gene therapy to treat orphan or common diseases constitute a new challenge for investigators and clinical sites. We describe the requirements and challenges of drug management in conformity with Good Clinical Practices (GCPs) for investigators and sites participating in clinical trials. Review At all sites participating in clinical trials, standard operating procedures (SOPs) covering the critical path of drug and drug delivery systems management are required. All steps should be auditable, including reception, validation, storage, access, preparation, distribution, techniques of administration, use, return, and destruction of research products. Biodrugs require traceability and specific SOPs on the management of potential immune reactions. Investigational products must be stored under standard auditable conditions. The traceability of storage conditions (including temperature) requires these conditions to be monitored on a continuous basis. A dedicated space with restricted access limited to authorized qualified personnel facilitates the monitoring. The development of standardized, auditable settings and the application of dedicated, site-specific SOPs for the management of investigational products and drug delivery systems contribute to guarantee the compliance to GCP requirements.

Combining the role of convenience and consideration set size in explaining fish consumption in Norway.

Science.gov (United States)

Rortveit, Asbjorn Warvik; Olsen, Svein Ottar

2009-04-01

The purpose of this study is to explore how convenience orientation, perceived product inconvenience and consideration set size are related to attitudes towards fish and fish consumption. The authors present a structural equation model (SEM) based on the integration of two previous studies. The results of a SEM analysis using Lisrel 8.72 on data from a Norwegian consumer survey (n=1630) suggest that convenience orientation and perceived product inconvenience have a negative effect on both consideration set size and consumption frequency. Attitude towards fish has the greatest impact on consumption frequency. The results also indicate that perceived product inconvenience is a key variable since it has a significant impact on attitude, and on consideration set size and consumption frequency. Further, the analyses confirm earlier findings suggesting that the effect of convenience orientation on consumption is partially mediated through perceived product inconvenience. The study also confirms earlier findings suggesting that the consideration set size affects consumption frequency. Practical implications drawn from this research are that the seafood industry would benefit from developing and positioning products that change beliefs about fish as an inconvenient product. Future research for other food categories should be done to enhance the external validity.

Bioethical Considerations of Advancing the Application of Marine Biotechnology and Aquaculture.

Science.gov (United States)

Harrell, Reginal M

2017-06-24

Normative ethical considerations of growth of the marine biotechnology and aquaculture disciplines in biopharming, food production, and marine products commercialization from a bioethical perspective have been limited. This paucity of information begs the question of what constitutes a bioethical approach (i.e., respect for individuals or autonomy; beneficence, nonmaleficence, and justice) to marine biotechnology and aquaculture, and whether it is one that is appropriate for consideration. Currently, thoughtful discussion on the bioethical implications of use, development, and commercialization of marine organisms or their products, as well as potential environmental effects, defaults to human biomedicine as a model. One must question the validity of using human bioethical principlism moral norms for appropriating a responsible marine biotechnology and aquaculture ethic. When considering potential impacts within these disciplines, deference must be given to differing value systems in order to find common ground to advance knowledge and avoid emotive impasses that can hinder the science and its application. The import of bioethical considerations when conducting research and/or production is discussed. This discussion is directed toward applying bioethical principles toward technology used for food, biomedical development (e.g., biopharming), or as model species for advancement of knowledge for human diseases.

Bioethical Considerations of Advancing the Application of Marine Biotechnology and Aquaculture

Directory of Open Access Journals (Sweden)

Reginal M. Harrell

2017-06-01

Full Text Available Normative ethical considerations of growth of the marine biotechnology and aquaculture disciplines in biopharming, food production, and marine products commercialization from a bioethical perspective have been limited. This paucity of information begs the question of what constitutes a bioethical approach (i.e., respect for individuals or autonomy; beneficence, nonmaleficence, and justice to marine biotechnology and aquaculture, and whether it is one that is appropriate for consideration. Currently, thoughtful discussion on the bioethical implications of use, development, and commercialization of marine organisms or their products, as well as potential environmental effects, defaults to human biomedicine as a model. One must question the validity of using human bioethical principlism moral norms for appropriating a responsible marine biotechnology and aquaculture ethic. When considering potential impacts within these disciplines, deference must be given to differing value systems in order to find common ground to advance knowledge and avoid emotive impasses that can hinder the science and its application. The import of bioethical considerations when conducting research and/or production is discussed. This discussion is directed toward applying bioethical principles toward technology used for food, biomedical development (e.g., biopharming, or as model species for advancement of knowledge for human diseases.

Association of clinical signs after acute Schmallenberg virus infection with milk production and fertility in Swiss dairy cows.

Science.gov (United States)

Lechner, Isabel; Wüthrich, Marianne; Meylan, Mireille; van den Borne, Bart H P; Schüpbach-Regula, Gertraud

2017-10-01

Since its first occurrence in August 2011 in Germany and the Netherlands, the Schmallenberg virus (SBV) spread rapidly across Europe, where it caused production losses and abortions in ruminants as well as congenital malformations in the offspring of affected animals. Several studies have investigated the impact of SBV on fertility and production parameters in dairy cows at herd level. However, the impact of clinical disease at the animal level remained undetermined. This study aimed at estimating the impact of clinical disease during and after an infection with SBV on production and fertility parameters in individual Swiss dairy cows. Sixty-seven case and twenty-four control herds were selected according to whether cows had been showing clinical signs indicative of SBV during the epidemic from July to December 2012 in Switzerland. Of these 91 farms, production and fertility data from 388 cows with clinical signs from case herds were collected over a time period of four years, and compared to data from 932 cows without clinical signs originating from case or control herds. Milk yield, somatic cell count, number of inseminations and non-return at day 56 were analysed by means of hierarchical multivariable regression analysis. A significant drop in milk yield was observed in all groups during the SBV epidemic compared to the time before the infection, which amounted to 1.9kg per test day for clinical animals, 1.1kg for non-clinical animals from case herds and 0.6kg for non-clinical animals from control herds. A prolonged effect on milk yield was observed in clinical cows for about one year, suggesting that animals with clinical disease might not return to their previous milk production level in the current lactation after an acute infection with SBV. Clinical animals showed a significantly higher somatic cell count during the epidemic compared to the time before the infection. The number of inseminations per cow and production cycle was higher for clinical animals

Solid waste production and its management in dental clinics in Gorgan, northern Iran.

Science.gov (United States)

Nabizadeh, R; Faraji, H; Mohammadi, A A

2014-10-01

Waste produced in dental clinics has been the topic of investigations for many years. These waste materials have important health impacts and are hazardous to humans and the environment. To investigating solid waste production and its management in dental clinics in Gorgan, northern Iran. In this cross-sectional study, 45 of 143 public dental practices and 5 of 25 private dental practices were selected and studied. From each clinic, 3 samples were taken and analyzed at the end of successive working days (Tuesday and Wednesday). Samples were manually sorted into 50 components. The measured components were then classified on the basis of their characteristics, hazard potentials, and WHO classification. The total annual amount of dental waste produced in public and private dental practices in Gorgan was 12 015.1 and 3135.0 kg, respectively. Production percentages of infectious, domestic, chemical and pharmaceutical, and toxic waste in public dental practices were 38.4%, 33.7%, 6.6%, and 0.6%, respectively. The percentages for private practices were 8.7%, 10.6%, 1.1%, and 0.1%, respectively. Dental waste management in Gorgan is inadequate; dental waste is not properly segregated, collected, and disposed, as demanded by the WHO. Employees in dentist offices must be trained in correct handling of waste products and the associated risks.

Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications.

Science.gov (United States)

Riboh, Jonathan C; Saltzman, Bryan M; Yanke, Adam B; Cole, Brian J

2016-09-01

Amniotic membrane (AM)-derived products have been successfully used in ophthalmology, plastic surgery, and wound care, but little is known about their potential applications in orthopaedic sports medicine. To provide an updated review of the basic science and preclinical and clinical data supporting the use of AM-derived products and to review their current applications in sports medicine. Systematic review. A systematic search of the literature was conducted using the Medline, EMBASE, and Cochrane databases. The search term amniotic membrane was used alone and in conjunction with stem cell, orthopaedic, tissue engineering, scaffold, and sports medicine. The search identified 6870 articles, 80 of which, after screening of the titles and abstracts, were considered relevant to this study. Fifty-five articles described the anatomy, basic science, and nonorthopaedic applications of AM-derived products. Twenty-five articles described preclinical and clinical trials of AM-derived products for orthopaedic sports medicine. Because the level of evidence obtained from this search was not adequate for systematic review or meta-analysis, a current concepts review on the anatomy, physiology, and clinical uses of AM-derived products is presented. Amniotic membranes have many promising applications in sports medicine. They are a source of pluripotent cells, highly organized collagen, antifibrotic and anti-inflammatory cytokines, immunomodulators, and matrix proteins. These properties may make it beneficial when applied as tissue engineering scaffolds, improving tissue organization in healing, and treatment of the arthritic joint. The current body of evidence in sports medicine is heavily biased toward in vitro and animal studies, with little to no human clinical data. Nonetheless, 14 companies or distributors offer commercial AM products. The preparation and formulation of these products alter their biological and mechanical properties, and a thorough understanding of these

75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

Science.gov (United States)

2010-10-14

...] Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance provides... Products: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance...

Production of radioisotopes for medical use

International Nuclear Information System (INIS)

Ido, Tatsuo

1977-01-01

As problems in the process of production of short-lived radioisotopes for medical use and in clinical application of them, the following three items were mentioned: 1. separation and purification in a short time, 2. devices to decrease exposure dose in workers, and 3. preservation of radiochemical purity and chemical purity, and avoidance of mixture of impurities. In consideration of these problems, an outline of on-line production system of radioactive gases (from irradiation by accelerated particles to separation, purification, and administration of them), which was exploited in National Institute of Radiological Sciences, was described. Production of 13 NH 3 , the aqueous solution of 18 F, and 123 I was also given an outline. Simultaneous production method of many nuclides by means of laminated target and compounds labelled with positron emitter were also described. (Tsunoda, M.)

Management of infections in critically ill returning travellers in the intensive care unit—II: clinical syndromes and special considerations in immunocompromised patients

Directory of Open Access Journals (Sweden)

Jordi Rello

2016-07-01

Full Text Available This position paper is the second ESCMID Consensus Document on this subject and aims to provide intensivists, infectious disease specialists, and emergency physicians with a standardized approach to the management of serious travel-related infections in the intensive care unit (ICU or the emergency department. This document is a cooperative effort between members of two European Society of Clinical Microbiology and Infectious Diseases (ESCMID study groups and was coordinated by Hakan Leblebicioglu and Jordi Rello for ESGITM (ESCMID Study Group for Infections in Travellers and Migrants and ESGCIP (ESCMID Study Group for Infections in Critically Ill Patients, respectively. A relevant expert on the subject of each section prepared the first draft which was then edited and approved by additional members from both ESCMID study groups. This article summarizes considerations regarding clinical syndromes requiring ICU admission in travellers, covering immunocompromised patients.

Dendritic cells for active immunotherapy: optimizing design and manufacture in order to develop commercially and clinically viable products.

Science.gov (United States)

Nicolette, C A; Healey, D; Tcherepanova, I; Whelton, P; Monesmith, T; Coombs, L; Finke, L H; Whiteside, T; Miesowicz, F

2007-09-27

Dendritic cell (DC) active immunotherapy is potentially efficacious in a broad array of malignant disease settings. However, challenges remain in optimizing DC-based therapy for maximum clinical efficacy within manufacturing processes that permit quality control and scale-up of consistent products. In this review we discuss the critical issues that must be addressed in order to optimize DC-based product design and manufacture, and highlight the DC based platforms currently addressing these issues. Variables in DC-based product design include the type of antigenic payload used, DC maturation steps and activation processes, and functional assays. Issues to consider in development include: (a) minimizing the invasiveness of patient biological material collection; (b) minimizing handling and manipulations of tissue at the clinical site; (c) centralized product manufacturing and standardized processing and capacity for commercial-scale production; (d) rapid product release turnaround time; (e) the ability to manufacture sufficient product from limited starting material; and (f) standardized release criteria for DC phenotype and function. Improvements in the design and manufacture of DC products have resulted in a handful of promising leads currently in clinical development.

Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review

Directory of Open Access Journals (Sweden)

Stephanie Armstrong

2017-09-01

Full Text Available Abstract Background We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. Methods A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. Results In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Conclusions Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent. Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

Science.gov (United States)

Armstrong, Stephanie; Langlois, Adele; Laparidou, Despina; Dixon, Mark; Appleton, Jason P; Bath, Philip M; Snooks, Helen; Siriwardena, A Niroshan

2017-09-16

We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

Personalizing medicine with clinical pharmacogenetics

Science.gov (United States)

Scott, Stuart A.

2012-01-01

Clinical genetic testing has grown substantially over the past 30 years as the causative mutations for Mendelian diseases have been identified, particularly aided in part by the recent advances in molecular-based technologies. Importantly, the adoption of new tests and testing strategies (e.g., diagnostic confirmation, prenatal testing, and population-based carrier screening) has often been met with caution and careful consideration before clinical implementation, which facilitates the appropriate use of new genetic tests. Although the field of pharmacogenetics was established in the 1950s, clinical testing for constitutional pharmacogenetic variants implicated in interindividual drug response variability has only recently become available to help clinicians guide pharmacotherapy, in part due to US Food and Drug Administration-mediated product insert revisions that include pharmacogenetic information for selected drugs. However, despite pharmacogenetic associations with adverse outcomes, physician uptake of clinical pharmacogenetic testing has been slow. Compared with testing for Mendelian diseases, pharmacogenetic testing for certain indications can have a lower positive predictive value, which is one reason for underutilization. A number of other barriers remain with implementing clinical pharmacogenetics, including clinical utility, professional education, and regulatory and reimbursement issues, among others. This review presents some of the current opportunities and challenges with implementing clinical pharmacogenetic testing. PMID:22095251

Considerations for sustainable influenza vaccine production in developing countries.

Science.gov (United States)

Nannei, Claudia; Chadwick, Christopher; Fatima, Hiba; Goldin, Shoshanna; Grubo, Myriam; Ganim, Alexandra

2016-10-26

Through its Global Action Plan for Influenza Vaccines (GAP), the World Health Organization (WHO) in collaboration with the United States Department of Health and Human Services has produced a checklist to support policy-makers and influenza vaccine manufacturers in identifying key technological, political, financial, and logistical issues affecting the sustainability of influenza vaccine production. This checklist highlights actions in five key areas that are beneficial for establishing successful local vaccine manufacturing. These five areas comprise: (1) the policy environment and health-care systems; (2) surveillance systems and influenza evidence; (3) product development and manufacturing; (4) product approval and regulation; and (5) communication to support influenza vaccination. Incorporating the checklist into national vaccine production programmes has identified the policy gaps and next steps for countries involved in GAP's Technology Transfer Initiative. Lessons learnt from country experiences provide context and insight that complement the checklist's goal of simplifying the complexities of influenza prevention, preparedness, and vaccine manufacturing. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

CONSIDERATIONS IN UTILIZING BY-PRODUCT CARBOHYDRATES IN RUMINANT NUTRITION

Science.gov (United States)

By-product feeds provide a variety of carbohydrates that can vary greatly in their content, digestibility, and physical effects. Variation in the composition and quality of by-product feeds needs to be evaluated to assess whether the variation poses an acceptable risk for inclusion of small or larg...

Evaluation Considerations for Secondary Uses of Clinical Data: Principles for an Evidence-based Approach to Policy and Implementation of Secondary Analysis.

Science.gov (United States)

Scott, P J; Rigby, M; Ammenwerth, E; McNair, J Brender; Georgiou, A; Hyppönen, H; de Keizer, N; Magrabi, F; Nykänen, P; Gude, W T; Hackl, W

2017-08-01

Objectives: To set the scientific context and then suggest principles for an evidence-based approach to secondary uses of clinical data, covering both evaluation of the secondary uses of data and evaluation of health systems and services based upon secondary uses of data. Method: Working Group review of selected literature and policy approaches. Results: We present important considerations in the evaluation of secondary uses of clinical data from the angles of governance and trust, theory, semantics, and policy. We make the case for a multi-level and multi-factorial approach to the evaluation of secondary uses of clinical data and describe a methodological framework for best practice. We emphasise the importance of evaluating the governance of secondary uses of health data in maintaining trust, which is essential for such uses. We also offer examples of the re-use of routine health data to demonstrate how it can support evaluation of clinical performance and optimize health IT system design. Conclusions: Great expectations are resting upon "Big Data" and innovative analytics. However, to build and maintain public trust, improve data reliability, and assure the validity of analytic inferences, there must be independent and transparent evaluation. A mature and evidence-based approach needs not merely data science, but must be guided by the broader concerns of applied health informatics. Georg Thieme Verlag KG Stuttgart.

Accelerated oral nanomedicine discovery from miniaturized screening to clinical production exemplified by paediatric HIV nanotherapies

Science.gov (United States)

Giardiello, Marco; Liptrott, Neill J.; McDonald, Tom O.; Moss, Darren; Siccardi, Marco; Martin, Phil; Smith, Darren; Gurjar, Rohan; Rannard, Steve P.; Owen, Andrew

2016-10-01

Considerable scope exists to vary the physical and chemical properties of nanoparticles, with subsequent impact on biological interactions; however, no accelerated process to access large nanoparticle material space is currently available, hampering the development of new nanomedicines. In particular, no clinically available nanotherapies exist for HIV populations and conventional paediatric HIV medicines are poorly available; one current paediatric formulation utilizes high ethanol concentrations to solubilize lopinavir, a poorly soluble antiretroviral. Here we apply accelerated nanomedicine discovery to generate a potential aqueous paediatric HIV nanotherapy, with clinical translation and regulatory approval for human evaluation. Our rapid small-scale screening approach yields large libraries of solid drug nanoparticles (160 individual components) targeting oral dose. Screening uses 1 mg of drug compound per library member and iterative pharmacological and chemical evaluation establishes potential candidates for progression through to clinical manufacture. The wide applicability of our strategy has implications for multiple therapy development programmes.

Relationship Between Work Productivity and Clinical Characteristics in Rheumatoid Arthritis.

Science.gov (United States)

Salazar-Mejía, Carlos Eduardo; Galarza-Delgado, Dionicio Ángel; Colunga-Pedraza, Iris Jazmín; Azpiri-López, José Ramón; Wah-Suárez, Martín; Wimer-Castillo, Blanca Otilia; Salazar-Sepúlveda, Laura Leticia

2018-03-01

This study assesses the relationship between the ability to perform productive activities and the clinical characteristics of RA, such as disease activity, quality of life, functional capacity, workload, pharmacotherapy, and comorbidities. A cross-sectional, observational and descriptive study was conducted. Patients aged 18-75years with a diagnosis of RA according to ACR/EULAR 2010 criteria who attended regularly to the Rheumatology service in the period between January and March 2017 were included. The questionnaires, WPAI-AR, HAQ-DI and RAQoL, were applied. RA disease activity was measured by DAS28-PCR. Correlations were made between the clinical data obtained and work productivity and activity impairment measured by WPAI-AR. Two hundred four patients with a diagnosis of RA were included, of whom 92.6% were women. Mean age was 54.46±9.3years. Regarding the percentage of impairment of daily life activities, we found a significant difference between employed and unemployed patients (P≤.002). A positive correlation was found between RA activity measured by DAS28-PCR, quality of life, and functional ability with the percentages of absenteeism, presenteeism, overall productivity loss, and impairment of daily life activities. A correlation between RA disease activity, functional capacity, quality of life, and working impairment was found. The strongest association was established with the degree of functional capacity. Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

Clinical considerations of Monte Carlo for electron radiotherapy treatment planning

International Nuclear Information System (INIS)

Faddegon, Bruce; Balogh, Judith; Mackenzie, Robert; Scora, Daryl

1998-01-01

Technical requirements for Monte Carlo based electron radiotherapy treatment planning are outlined. The targeted overall accuracy for estimate of the delivered dose is the least restrictive of 5% in dose, 5 mm in isodose position. A system based on EGS4 and capable of achieving this accuracy is described. Experience gained in system design and commissioning is summarized. The key obstacle to widespread clinical use of Monte Carlo is lack of clinically acceptable measurement based methodology for accurate commissioning

Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice.

Science.gov (United States)

Gándara, Carolina; Affleck, Valerie; Stoll, Elizabeth Ann

2018-02-01

Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet, the manufacture of these vectors is challenging, especially at high titers required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation. The goals of this paper are to report the protocol for manufacturing high-titer third-generation lentivirus for preclinical testing and to provide detailed information on considerations for translating preclinical viral vector manufacture toward scaled-up platforms and processes in order to make gene therapies under Good Manufacturing Practice that are suitable for clinical trials.

Lyme Disease: Emergency Department Considerations.

Science.gov (United States)

Applegren, Nathan D; Kraus, Chadd K

2017-06-01

Lyme disease (LD) is the most common vector-borne illness in North America. Reported cases of LD have increased from approximately 10,000 cases annually in 1991 to >25,000 cases in 2014. Greater recognition, enhanced surveillance, and public education have contributed to the increased prevalence, as have geographic expansion and the number of infected ticks. Cases are reported primarily in the Northeastern United States, Wisconsin, and Minnesota, with children having the highest incidence of LD among all age groups. The increased incidence and prevalence of LD in the United States makes it increasingly more common for patients to present to the emergency department (ED) for tick bites and LD-related chief complaints, such as the characteristic erythema migrans skin manifestation. We sought to review the etiology of LD, describe its clinical presentations and sequela, and provide a practical classification and approach to ED management of patients with LD-related presentations. In this review, ED considerations for LD are presented and clinical presentations and management of the disease at different stages is discussed. Delayed sequelae that have significant morbidity, including Lyme carditis and Lyme neuroborreliosis, are discussed. Diagnostic tests and management are described in detail. The increasing prevalence and growing geographic reach of Lyme disease makes it critically important for emergency physicians to consider the diagnosis in patients presenting with symptoms suggestive of LD and to initiate appropriate treatment to minimize the potential of delayed sequelae. Special consideration should be made for the epidemiology of LD and a high clinical suspicion should be present for patients in endemic areas or with known exposures to ticks. Emergency physicians can play a critical role in the recognition, diagnosis, and treatment of LD. Copyright © 2017 Elsevier Inc. All rights reserved.

REQUIREMENTS ON CLINICAL TRIALS FOR VETERINARY PHARMACEUTICAL PRODUCTS FOR FISH

Directory of Open Access Journals (Sweden)

Simona Sturzu

2016-12-01

Full Text Available Veterinary pharmaceutical products intended for use in fish should comply with all usual requirements regarding approval for marketing, according to the Order of the President of the National Sanitary Veterinary Agency and for Food Safety No.187/2007, with subsequent amendments and additions. According to the legislation the technical file should containe documentation of quality, safety of animals, consumer, user and environment and demonstration of efficacy and tolerance in the target species. This paper provides the important information on requirements for demonstration on efficacy of pharmaceutical products indended for use in fish. The principal aim of the efficacy data is to prove the therapeutic value of pharmaceutical products and to establish an optimal dose and period of dose administration. In efficacity clinical trial is needed, also, to take into account, the various conditions such as climatic aspects, disease situation, water temperature and salinity, because these may influence the outcome and veracity of the studies.

Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

DEFF Research Database (Denmark)

Gluud, Christian; Kubiak, Christine; Whitfield, Kate

2012-01-01

In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.......In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe....

Solid Waste Production and Its Management in Dental Clinics in Gorgan, Northern Iran

Directory of Open Access Journals (Sweden)

R Nabizadeh

2014-09-01

Full Text Available Background: Waste produced in dental clinics has been the topic of investigations for many years. These waste materials have important health impacts and are hazardous to humans and the environment. Objective: To investigating solid waste production and its management in dental clinics in Gorgan, northern Iran. Methods: In this cross-sectional study, 45 of 143 public dental practices and 5 of 25 private dental practices were selected and studied. From each clinic, 3 samples were taken and analyzed at the end of successive working days (Tuesday and Wednesday. Samples were manually sorted into 50 components. The measured components were then classified on the basis of their characteristics, hazard potentials, and WHO classification. Results: The total annual amount of dental waste produced in public and private dental practices in Gorgan was 12 015.1 and 3135.0 kg, respectively. Production percentages of infectious, domestic, chemical and pharmaceutical, and toxic waste in public dental practices were 38.4%, 33.7%, 6.6%, and 0.6%, respectively. The percentages for private practices were 8.7%, 10.6%, 1.1%, and 0.1%, respectively. Conclusion: Dental waste management in Gorgan is inadequate; dental waste is not properly segregated, collected, and disposed, as demanded by the WHO. Employees in dentist offices must be trained in correct handling of waste products and the associated risks.

Clinical consideration of fungal paranasal sinusitis

International Nuclear Information System (INIS)

Okuni, Tsuyoshi; Asakura, Koji; Homma, Tomo; Kawaguchi, Ryuichi; Ishikawa, Tadataka; Yamazaki, Norikazu; Himi, Tetsuo

2008-01-01

Fungal paranasal sinusitis is included in the differential diagnosis of unilateral paranasal lesion. Recently the incidence of fungal paranasal sinusitis has been increasing. We reviewed 24 patients (9 males and 15 females) with fungal paranasal sinusitis treated at Muroran City Hospital between January 2001 and May 2006, and clinical presentation and CT findings with those of 56 patients (36 males and 20 females) with chronic unilateral sinusitis. Fungal sinusitis patients ranged in age from 45 to 87, and the average age was 65.9 years old. In contrast, the age of chronic sinusitis patients ranged from 24 to 83, and the average age was 54.4 years old. The chief complaint of both fungal sinusitis and chronic sinusitis included rhinorrhea, nasal obstruction and post nasal discharge. CT exam was performed in all patients. In 23 cases of paranasal fungal sinusitis and 54 cases of chronic sinusitis the findings involved the maxillary sinus. The most common observation (69.6%) was bone density within the affected sinus in fungal sinusitis. However, only 2 cases of chronic sinusitis (3.9%) showed calcification. All cases of fungal sinusitis were diagnosed by pathological examinations. Most cases were proved to be aspergillus, while only one case was mucor. We treated all cases surgically, 18 cases underwent Caldwell-Luc's procedure and 5 cases underwent endoscopic sinus surgery under local anesthesia. (author)

9 CFR 202.115 - Rule 15: Submission for final consideration.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Rule 15: Submission for final consideration. 202.115 Section 202.115 Animals and Animal Products GRAIN INSPECTION, PACKERS AND STOCKYARDS... the judicial officer for decision. (d) Oral argument. There shall be no right to oral argument other...

16 CFR 1012.1 - General policy considerations; scope.

Science.gov (United States)

2010-01-01

... Policy, sets forth requirements for advance public notice, public attendance, and recordkeeping for... 16 Commercial Practices 2 2010-01-01 2010-01-01 false General policy considerations; scope. 1012.1 Section 1012.1 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL MEETINGS POLICY-MEETINGS...

Diagnostic Consideration for Sinonasal Wegener’s Granulomatosis Clinically Mistaken for Carcinoma

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Cristina La Rosa

2013-01-01

Full Text Available We report a case of Wegener’s granulomatosis clinically mistaken for carcinoma in a 21-year-old girl presenting with an ulcerated mass of the nasopharynx associated with enlarged laterocervical nodes. The lesion was clinically suspected as malignant on the basis of clinical and radiological findings (namely, computed tomography scan and positron emission tomography. However, multiple biopsies were not conclusive for malignancy showing histological change suggestive of Wegener’s granulomatosis. A serum determination of cANCA supported the diagnosis of Wegener’s granulomatosis. Clinical findings and image studies suggested an erroneous diagnosis of malignancy whereas a definitive diagnosis of Wegener’s granulomatosis was achieved only after repeated biopsies thus leading to a correct therapeutic approach. The Wegener granulomatosis must be added to the list of the differential diagnoses of the masses of the nasopharynx associated with or without enlarged laterocervical nodes.

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

Science.gov (United States)

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project

Examination of the Locus of Positional Effects on Children's Production of Plural -s: Considerations From Local and Global Speech Planning.

Science.gov (United States)

Theodore, Rachel M; Demuth, Katherine; Shattuck-Hufnagel, Stefanie

2015-06-01

Prosodic and articulatory factors influence children's production of inflectional morphemes. For example, plural -s is produced more reliably in utterance-final compared to utterance-medial position (i.e., the positional effect), which has been attributed to the increased planning time in utterance-final position. In previous investigations of plural -s, utterance-medial plurals were followed by a stop consonant (e.g., dogsbark), inducing high articulatory complexity. We examined whether the positional effect would be observed if the utterance-medial context were simplified to a following vowel. An elicited imitation task was used to collect productions of plural nouns from 2-year-old children. Nouns were elicited utterance-medially and utterance-finally, with the medial plural followed by either a stressed or an unstressed vowel. Acoustic analysis was used to identify evidence of morpheme production. The positional effect was absent when the morpheme was followed by a vowel (e.g., dogseat). However, it returned when the vowel-initial word contained 2 syllables (e.g., dogsarrive), suggesting that the increased processing load in the latter condition negated the facilitative effect of the easy articulatory context. Children's productions of grammatical morphemes reflect a rich interaction between emerging levels of linguistic competence, raising considerations for diagnosis and rehabilitation of language disorders.

484 Allergen Standardisation in Allergens and Allergoids—Challenges and Considerations

Science.gov (United States)

Skinner, Murray; Bullimore, Alan; Hewings, Simon; Swan, Nicola

2012-01-01

Background The range of therapeutics and dosing schedules for allergen preparations and allergoids produced and used clinically are considerable. Standardisation of allergy immunotherapies is considered a positive step; however there are difficulties in identifying universal metrics for standardisation. Many advocate the use of major allergen content whilst others advocate total allergenicity. Additionally as a compounding argument, where major allergen is used, many disagree on what the major allergen is for certain species. Methods Major allergen content measurement allows a consistent recognised measure, and IgE responses of a serum pool are often dominated by IgE against major allergens. However issues such as specificity of different assays toward isoforms and other variants of single allergens often results in diverging allergen contents that can cause unexpected and misleading disparity. Other aspects that increase complication are the relevance to modified allergens, use of adjuvants and differing dosing regimes. Results The major allergen content of key products in different therapeutic formats has been measured. Conclusions This has been performed in conjunction with techniques such as total allergenicity, as allergy treatments and therapeutics require careful characterisation to allow supply of consistent, safe and efficacious products.

Considerations in the development of circulating tumor cell technology for clinical use

Directory of Open Access Journals (Sweden)

Parkinson David R

2012-07-01

Full Text Available Abstract This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker development–analytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA and the US National Cancer Institute (NCI.

Essays on Product Strategies through Consideration of Individual Distributions

OpenAIRE

Perry, Hagit

2016-01-01

Marketing literature and practitioners are in agreement that it is essential for brands in competitive markets to identify segments that should be targeted and to build rational product strategies that target these segments. It is essential because most markets include consumers with heterogeneous preferences and precise segmentation and targeting creates product differentiation, which prevents direct competition and allow the market to reach an optimal profit optimization equilibrium. In thi...

Clinical proton dosimetry. Part 1: Beam production, beam delivery and measurement of absorbed dose

International Nuclear Information System (INIS)

1998-01-01

The development of accurate and uniform standards for radiation treatment dosimetry has been a continuing effort since the earliest days of radiotherapy. This ICRU Report is intended to promote uniformity of standards that will provide a basis for world-wide comparison of clinical results and allow the development of meaningful clinical trials. This Report describes current practice in proton therapy and recommends standards for the dosimetry of proton treatments. Established proton treatment facilities might use this Report as a source of information for the maintenance of accurate standards. New facilities may build their procedures from recommendations found in this Report and planners of new facilities may examine alternatives within current practice for the production and monitoring of treatment beams. This Report includes a description of the interaction of protons with matter, various methods of beam production, the characteristics of proton beams in clinical use, current methods for beam monitoring and specific recommendations for dose calibration

Principle considerations for the risk assessment of sprayed consumer products.

Science.gov (United States)

Steiling, W; Bascompta, M; Carthew, P; Catalano, G; Corea, N; D'Haese, A; Jackson, P; Kromidas, L; Meurice, P; Rothe, H; Singal, M

2014-05-16

In recent years, the official regulation of chemicals and chemical products has been intensified. Explicitly for spray products enhanced requirements to assess the consumers'/professionals' exposure to such product type have been introduced. In this regard the Aerosol-Dispensers-Directive (75/324/EEC) with obligation for marketing aerosol dispensers, and the Cosmetic-Products-Regulation (1223/2009/EC) which obliges the insurance of a safety assessment, have to be mentioned. Both enactments, similar to the REACH regulation (1907/2006/EC), require a robust chemical safety assessment. From such assessment, appropriate risk management measures may be identified to adequately control the risk of these chemicals/products to human health and the environment when used. Currently, the above-mentioned regulations lack the guidance on which data are needed for preparing a proper hazard analysis and safety assessment of spray products. Mandatory in the process of inhalation risk and safety assessment is the determination and quantification of the actual exposure to the spray product and more specifically, its ingredients. In this respect the current article, prepared by the European Aerosol Federation (FEA, Brussels) task force "Inhalation Toxicology", intends to introduce toxicological principles and the state of the art in currently available exposure models adapted for typical application scenarios. This review on current methodologies is intended to guide safety assessors to better estimate inhalation exposure by using the most relevant data. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

The myeloproliferative neoplasms, unclassifiable: clinical and pathological considerations.

Science.gov (United States)

Gianelli, Umberto; Cattaneo, Daniele; Bossi, Anna; Cortinovis, Ivan; Boiocchi, Leonardo; Liu, Yen-Chun; Augello, Claudia; Bonometti, Arturo; Fiori, Stefano; Orofino, Nicola; Guidotti, Francesca; Orazi, Attilio; Iurlo, Alessandra

2017-02-01

In this study, we investigate in detail the morphological, clinical and molecular features of 71 consecutive patients with a diagnosis of myeloproliferative neoplasms, unclassifiable. We performed a meticulous morphological analysis and found that most of the cases displayed a hypercellular bone marrow (70%) with normal erythropoiesis without left-shifting (59%), increased granulopoiesis with left-shifting (73%) and increased megakaryocytes with loose clustering (96%). Megakaryocytes displayed frequent giant forms with hyperlobulated or bulbous nuclei and/or other maturation defects. Interestingly, more than half of the cases displayed severe bone marrow fibrosis (59%). Median values of hemoglobin level and white blood cells count were all within the normal range; in contrast, median platelets count and lactate dehydrogenase were increased. Little less than half of the patients (44%) showed splenomegaly. JAK2V617F mutation was detected in 72% of all patients. Among the JAK2-negative cases, MPLW515L mutation was found in 17% and CALR mutations in 67% of the investigated cases, respectively. Finally, by multiple correspondence analysis of the morphological profiles, we found that all but four of the cases could be grouped in three morphological clusters with some features similar to those of the classic BCR-ABL1-negative myeloproliferative neoplasms. Analysis of the clinical parameters in these three clusters revealed discrepancies with the morphological profile in about 55% of the patients. In conclusion, we found that the category of myeloproliferative neoplasm, unclassifiable is heterogeneous but identification of different subgroups is possible and should be recommended for a better management of these patients.

Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials

DEFF Research Database (Denmark)

Petkovic, Jennifer; Barton, Jennifer L; Flurey, Caroline

2017-01-01

, and (6) consideration of statistical power of subgroup analyses for outcome reporting. CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking...

Clinical status, quality of life, and work productivity in Crohn's disease patients after one year of treatment with adalimumab.

Science.gov (United States)

Saro, Cristina; Ceballos, Daniel; Muñoz, Fernando; de la Coba, Cristóbal; Aguilar, María Dolores; Lázaro, Pablo; García-Sánchez, Valle; Hernández, Mariola; Barrio, Jesús; de Francisco, Ruth; Fernández, Luis I; Barreiro-de Acosta, Manuel

2017-02-01

Clinical trials have shown the efficacy of adalimumab in Crohn's disease, but the outcome in regular practice remains unknown. The aim of the study was to examine clinical status, quality of life, and work productivity of Crohn's disease patients receiving adalimumab for one year in the context of usual clinical practice. This was a prospective, observational study with a one-year follow-up. After baseline, Crohn's disease patients were evaluated at 1, 3, 6, 9, and 12 months after starting treatment with adalimumab. Outcome variables included: clinical status (measured with CDAI), quality of life (measured with EuroQoL-5D and IBDQ), and work productivity (measured with WPAI questionnaire). These outcome variables were compared using the Student's t test or Wilcoxon test for paired comparison data according to the data distribution. Statistical significance was set at two-sided p work productivity impact decreased from 53% to 24% (p quality of life and work productivity.

IT and security considerations for online clinical records.

Science.gov (United States)

Williams, Patricia A H

2010-03-01

E-health and the national electronic medical record are on our doorstep. As an integral part of the healthcare system, dentistry needs to get on board with this national initiative. How prepared is the dental profession for this? How can a culture of online clinical records be promoted and what protocols and infrastructure exist for this to occur? The lack of government restriction means that dentistry should be taking full advantage of what is possible. The benefits and barriers to adoption of online records will be presented to provide a frame of reference for the next major shift in electronic communication.

Hyperthermia: Clinical promise and current challenges

International Nuclear Information System (INIS)

Kapp, D.S.

1987-01-01

Local-regional hyperthermia (HT) when used in conjunction with radiation therapy (XRT), has been shown in numerous clinical trials to result in considerable improvement in response rates and local tumor control rates when compared with treatment by XRT alone. Although considerable progress has been made in understanding the biological basis for hyperthermia induced cytotoxicity and radiosensitization, additional research remains in establishing the optimal treatment schedules for the clinical utilization of HT-XRT. The number of HT treatments; the sequencing of HT and XRT; the frequency of administration of HT; and the ideal temperature-time parameters all remain to be better defined for the clinical setting. The role of tumor blood flow on the thermal distributions also warrants further investigation. In addition, considerable effort is needed to improve hyperthermia equipment in order to provide more uniform therapeutic temperature distributions (temperatures ≥42.5%C). Better heating equipment is particularly needed for the treatment of deep seeted tumors. Pertinent clinical literature will be presented summarizing the clinical promise of hyperthermia and the above mentioned clinical challenges

Manufacturing human mesenchymal stem cells at clinical scale: process and regulatory challenges.

Science.gov (United States)

Jossen, Valentin; van den Bos, Christian; Eibl, Regine; Eibl, Dieter

2018-05-01

Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. As economic considerations have shown, allogeneic therapy seems to be the most cost-effective method. Standardized procedures based on instrumented single-use bioreactors have been shown to provide billion of cells with consistent product quality and to be superior to traditional expansions in planar cultivation systems. Furthermore, under consideration of the complex nature and requirements of allogeneic hMSC-therapeutics, a new equipment for downstream processing (DSP) was successfully evaluated. This mini-review summarizes both the current state of the hMSC production process and the challenges which have to be taken into account when efficiently producing hMSCs for the clinical scale. Special emphasis is placed on the upstream processing (USP) and DSP operations which cover expansion, harvesting, detachment, separation, washing and concentration steps, and the regulatory demands.

Ideological Considerations in Official Dubbing in Iran

Directory of Open Access Journals (Sweden)

Masood Khoshsaligheh

2016-02-01

Full Text Available In our globalizing world, audiovisual products are understandably considered tools that advertise their original language and culture. Most societies do not stand any interference from the outside, especially if it considerably opposes the socio-cultural norms. Translation is a practice of cross-cultural communication which most often complies with the socio-cultural guidelines and norms of the recipient society. However, translated products might face resistance as they can be regarded threatening and hostile by the ruling gatekeepers. Given the dramatic disparities between most languages and cultures, translators are not the only decision-makers and other agents have pivotal roles in the process of adapting the translated product to the dominant conventions and socio-cultural norms. This paper aims at shedding some light on the role which agents play in the process of dubbing, both for public access national television and for private home distribution. The study explores the effects of preliminary and operational norms, and cultural appropriation conducted at both textual and visual levels through a method including interview data and textual analysis. The results show that foreign movies dubbed into Persian in the religious context of the contemporary Iran are strictly controlled both before the process of dubbing and during and after the process of dubbing due to a number of socio-cultural, political, and ideological considerations.

Organic quinoa (Chenopodium quinoa L.) production in Peru: Environmental hotspots and food security considerations using Life Cycle Assessment.

Science.gov (United States)

Cancino-Espinoza, Eduardo; Vázquez-Rowe, Ian; Quispe, Isabel

2018-05-08

Quinoa is a plant that is cultivated in the Andean highlands across Peru and Bolivia. It is increasingly popular due to its high nutritive value and protein content. In particular, the cultivation of organic quinoa has grown substantially in recent years since it is the most demanded type of quinoa in the foreign market. Nevertheless, despite the interest that quinoa has generated in terms of its nutritional properties, little is known regarding the environmental profile of its production and processing. Therefore, the main objective of this study was to analyze the environmental impacts that are linked to the production and distribution of organic quinoa to the main export destinations through the application of the Life Cycle Assessment (LCA) methodology. An attributional LCA perspective was conducted including data from approximately 55 ha of land used for quinoa production in the regions of Huancavelica and Ayacucho, in southern-central Peru. IPCC, 2013 and ReCiPe 2008 were the two assessment methods selected to estimate the environmental impact results using the SimaPro 8.3 software. Results, which were calculated for one 500 g package of organic quinoa, showed that GHG emissions are in the upper range of other organic agricultural products. However, when compared to other high protein content food products, especially those from animal origin, considerably low environmental impacts are obtained. For instance, if 20% of the average annual beef consumption in Peru is substituted by organic quinoa, each Peruvian would mitigate 31 kg CO 2 eq/year in their diet. Moreover, when the edible protein energy return on investment (i.e., ep-EROI) is computed, a ratio of 0.38 is obtained, in the higher range of protein rich food products. However, future research should delve into the environmental and food policy implications of agricultural land expansion to produce an increasing amount of quinoa for a growing global demand. Copyright © 2018 Elsevier B.V. All

77 FR 46764 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

Science.gov (United States)

2012-08-06

...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... per year. B. Research Objectives The goal of FDA's OPD grant program is to support the clinical... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of...

Mitochondrial Replacement Therapy: Halachic Considerations for Enrolling in an Experimental Clinical Trial

Science.gov (United States)

Tendler, Rabbi Moshe D.; Loike, John D.

2015-01-01

The transition of new biotechnologies into clinical trials is a critical step in approving a new drug or therapy in health care. Ethically recruiting appropriate volunteers for these clinical trials can be a challenging task for both the pharmaceutical companies and the US Food and Drug Administration. In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy. The halachic perspective encourages individuals to volunteer for such clinical trials under the ethical principles of beneficence and social responsibility, when animal studies have shown that health risks are minimal. PMID:26241230

Mitochondrial Replacement Therapy: Halachic Considerations for Enrolling in an Experimental Clinical Trial

Directory of Open Access Journals (Sweden)

Rabbi Moshe D. Tendler

2015-07-01

Full Text Available The transition of new biotechnologies into clinical trials is a critical step in approving a new drug or therapy in health care. Ethically recruiting appropriate volunteers for these clinical trials can be a challenging task for both the pharmaceutical companies and the US Food and Drug Administration. In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy. The halachic perspective encourages individuals to volunteer for such clinical trials under the ethical principles of beneficence and social responsibility, when animal studies have shown that health risks are minimal.

Clinical trial considerations on male contraception and collection of pregnancy information from female partners

Directory of Open Access Journals (Sweden)

Banholzer Maria

2012-06-01

Full Text Available Abstract Background There is little guidance regarding the risk of exposure of pregnant women/ women of childbearing potential to genotoxic or teratogenic compounds via vaginal dose delivered through seminal fluid during sexual intercourse. Method We summarize current thinking and provide clinical trial considerations for a consistent approach to contraception for males exposed to genotoxic and/or teratogenic compounds or to compounds of unknown teratogenicity, and for collection of pregnancy data from their female partners. Results Where toxicity testing demonstrates genotoxic potential, condom use is required during exposure and for 5 terminal plasma half-lives plus 74 days (one human spermatogenesis cycle to avoid conception. For non-genotoxic small molecules and immunoglobulins with unknown teratogenic potential or without a no observed adverse effect level (NOAEL from embryo-fetal development (EFD studies and no minimal anticipated biological effect level (MABEL, condom use is recommended for males with pregnant partner/female partner of childbearing potential. For teratogenic small molecules with estimated seminal fluid concentration and a margin between projected maternal area under the curve (AUC and NOAEL AUC from EFD studies of ≥300 (≥100 for immunoglobulins or in the absence of a NOAEL with a margin between MABEL plasma concentration and maternal Cmax of ≥300 (≥10 for immunoglobulins, condom use is not required. However, condom use is required for margins below the thresholds previously indicated. For small molecules with available seminal fluid concentrations, condom use is required if margins are Pregnancy data should be proactively collected if pregnancy occurs during the condom use period required for males exposed to first-in-class molecules or to molecules with a target/class shown to be teratogenic, embryotoxic or fetotoxic in human or preclinical experiments. Conclusion These recommendations, based on a precaution

THEORETICAL AND PRACTICAL CONSIDERATIONS REGARDING THE COST CALCULATION USING DIRECT COSTING

Directory of Open Access Journals (Sweden)

Cristina Aurora, Bunea-Bontaş

2012-01-01

Full Text Available The definition of the cost of production as applied to inventories refers to the acquisition and production cost, and its determination involves many considerations. This article emphasizes a comparative approach of the calculation of production cost under direct costing and absorption costing, and examines the impact of using these calculation systems on the financial performance of the companies presented in the income statement.

Disordered gambling: etiology, trajectory, and clinical considerations.

Science.gov (United States)

Shaffer, Howard J; Martin, Ryan

2011-01-01

Gambling-related research has advanced rapidly during the past 20 years. As a result of expanding interest in pathological gambling (PG), stakeholders (e.g., clinicians, regulators, and policy makers) have a better understanding of excessive gambling, including its etiology (e.g., neurobiological/neurogenetic, psychological, and sociological factors) and trajectory (e.g., initiation, course, and adaptation to gambling exposure). In this article, we examine these advances in PG-related research and then consider some of the clinical implications of these advances. We consider criteria changes for PG recently proposed by the DSM-V Impulse Control Work Group for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). We also review how clinicians can more accurately and efficiently diagnose clients seeking help for gambling-related problems by utilizing brief screens. Finally, we consider the importance of future research that can identify behavioral markers for PG. We suggest that identifying these markers will allow clinicians to make earlier diagnoses, recommend targeted treatments, and advance secondary prevention efforts. © 2011 by Annual Reviews. All rights reserved

Materials compatibility considerations for a fusion-fission hybrid reactor design

International Nuclear Information System (INIS)

DeVan, J.H.; Tortorelli, P.F.

1983-01-01

The Tandem Mirror Hybrid Reactor is a fusion reactor concept that incorporates a fission-suppressed breeding blanket for the production of 233 U to be used in conventional fission power reactors. The present paper reports on compatibility considerations related to the blanket design. These considerations include solid-solid interactions and liquid metal corrosion. Potential problems are discussed relative to the reference blanket operating temperature (490 0 C) and the recycling time of breeding materials (<1 year)

Advanced glycation end products in clinical nephrology.

Science.gov (United States)

Kalousová, M; Zima, T; Tesar, V; Stípek, S; Sulková, S

2004-01-01

As a result of oxidative and carbonyl stress, advanced glycation end products (AGEs) are involved in the pathogenesis of severe and frequent diseases and their fatal vascular/cardiovascular complications, i.e. diabetes mellitus and its complications (nephropathy, angiopathy, neuropathy and retinopathy, renal failure and uremic and dialysis-associated complications), atherosclerosis and dialysis-related amyloidosis, neurodegenerative diseases, and rheumatoid arthritis. They are formed via non-enzymatic glycation which is specifically enhanced through the presence of oxidative and carbonyl stress, and their ability to form glycoxidation products in peptide and protein structures finally modulating or inducing biological reactivity. Food can be another source of AGEs; however, high serum AGEs in hemodialysis patients might reflect nutritional status better. Several methods of renal replacement therapy have been studied in connection with the AGE removal, but unfortunately the possibilities are still unsatisfactory even if high flux dialysis, hemofiltration, or hemodiafiltration give better results than conventional low flux dialysis. AGEs are currently being studied in the patients on peritoneal dialysis as their precursors can be formed in the dialysis fluid. AGEs can cause damage to the peritoneum and so a loss of ultrafiltration capacity. Many compounds give promising results in AGE inhibition (inhibition of formation of AGEs, inhibition of their action or degradation of AGEs), are tested for these properties, and eventually undergo clinical studies (e.g. aminoguanidine, OPB-9195, pyridoxamine, antioxidants, N-phenacylthiazolium bromide, antihypertensive drugs, angiotensin-converting enzyme inhibitors and angiotensin II receptor-1 antagonists). Copyright 2004 S. Karger AG, Basel

Oligometastatic prostate cancer: definitions, clinical outcomes, and treatment considerations

Science.gov (United States)

Tosoian, Jeffrey J.; Gorin, Michael A.; Ross, Ashley E.; Pienta, Kenneth J.; Tran, Phuoc T.; Schaeffer, Edward M.

2018-01-01

The oligometastatic state has been proposed as an intermediate stage of cancer spread between localized disease and widespread metastases. With improvements in diagnostic modalities such as functional imaging, oligometastatic prostate cancer is being diagnosed with greater frequency than ever before. Furthermore, the paradigm for treatment of advanced prostate cancers is shifting toward a more aggressive approach. Many questions surround the understanding of the process and consequences of oligometastasis, meaning that the contemporary literature offers a wide variety of definitions of oligometastatic prostate cancer. Until genomic data exist to provide a biological component to the definition of oligometastatic disease, a clinical diagnosis made on the basis of up to five extrapelvic lesions is reasonable for use. Retrospective studies suggest that interventions such as radical prostatectomy and local or metastasis-directed radiotherapy can be performed in the metastatic setting with minimal risk of toxic effects. These therapies seem to decrease the need for subsequent palliative interventions, but insufficient data are available to draw reliable conclusions regarding their effect on survival. Thus, a protocol for clinicians to manage the patient presenting with oligometastatic prostate cancer would be a useful clinical tool. PMID:27725639

The changing face of Usher syndrome: clinical implications.

Science.gov (United States)

Cohen, Mazal; Bitner-Glindzicz, Maria; Luxon, Linda

2007-02-01

Usher syndrome is both genetically and phenotypically heterogeneous. Traditionally, the condition has been classified into three clinical types, differentiated by the severity and progression of the hearing impairment and by the presence or absence of vestibular symptoms. Recent advances in molecular genetics have enabled researchers to study the phenotypic expression in confirmed molecular groups of Usher. In response to the expansion of clinical and genetic information on Usher, we report an up to date review of the different clinical forms of Usher in known molecular groups and use the emerging evidence to appraise the diagnostic utility of the traditional classification of Usher. Our findings undermine the traditional view that the clinical types of Usher have distinct genetic causes. The pleiotropic effects of some of the major causes of Usher lead to considerable overlap between the different clinical types, with very little evidence for phenotypic-genotypic correlations. The novel synthesis emerging from this review suggests more productive approaches to the diagnosis of Usher in hearing-impaired children which would provide more accurate prognostic information to families.

Sleep Health Issues for Children with FASD: Clinical Considerations

OpenAIRE

Jan, James E.; Asante, Kwadwo O.; Conry, Julianne L.; Fast, Diane K.; Bax, Martin C. O.; Ipsiroglu, Osman S.; Bredberg, Elizabeth; Loock, Christine A.; Wasdell, Michael B.

2010-01-01

This article describes the combined clinical experience of a multidisciplinary group of professionals on the sleep disturbances of children with fetal alcohol spectrum disorders (FASD) focusing on sleep hygiene interventions. Such practical and comprehensive information is not available in the literature. Severe, persistent sleep difficulties are frequently associated with this condition but few health professionals are familiar with both FASD and sleep disorders. The sleep promotion techniqu...

Evaluating the utility of subjective effects measures for predicting product sampling, enrollment, and retention in a clinical trial of a smokeless tobacco product.

Science.gov (United States)

O'Connor, Richard J; Lindgren, Bruce R; Schneller, Liane M; Shields, Peter G; Hatsukami, Dorothy K

2018-01-01

Subjective effects of drugs, representing pharmacological and non-pharmacological effects, have been shown to be associated with future use and abuse. This also is the case for tobacco products and so measuring subjective effects, such as liking, satisfaction, and aversion, is crucial to gaining an understanding of consumer perception leading to increased use. This study examined the predictive validity of subjective drug and product effects with respect to product adoption. Smokers (N=151) were enrolled in Minneapolis, Columbus, and Buffalo. Participants were shown two snus products (Camel Snus Winterchill and Robust), asked to try each of the products for 5min and to rate them using the Product Evaluation Scale (PES) and Drug Effects Questionnaire (DEQ). This was followed by a one-week use period of their preferred product and those who used at least 1 unit of Camel Snus per day (or at least 7 pouches total) were eligible to enroll in the Clinical Trial Phase assessing the impact of complete switching or dual use with smoking. Key outcomes for this study were product evaluation, extent of product use, and Clinical Trial enrollment. We noted no relationships between participant characteristics such as gender, age, prior smokeless use, baseline cigarettes per day (CPD), or PES and DEQ scores with any of these outcome variables. Subjective effects were weak predictors of product use, which totaled approximately 3units of snus per day. Regardless of product, it appears that PES and DEQ ratings were uniformly poor predictors of trial enrollment and retention, though they do predict the amount of snus used during the sampling phase. Findings indicate that while subjective effects predict product preference in the short-term, they did not consistently predict extent of use or enrollment in the trial, suggesting that these initial measures have limited implications for long-term behavior. Copyright © 2017. Published by Elsevier Ltd.

Performance specifications and six sigma theory: Clinical chemistry and industry compared.

Science.gov (United States)

Oosterhuis, W P; Severens, M J M J

2018-04-11

Analytical performance specifications are crucial in test development and quality control. Although consensus has been reached on the use of biological variation to derive these specifications, no consensus has been reached which model should be preferred. The Six Sigma concept is widely applied in industry for quality specifications of products and can well be compared with Six Sigma models in clinical chemistry. However, the models for measurement specifications differ considerably between both fields: where the sigma metric is used in clinical chemistry, in industry the Number of Distinct Categories is used instead. In this study the models in both fields are compared and discussed. Copyright © 2018. Published by Elsevier Inc.

Social media for physiotherapy clinics: considerations in creating a Facebook page

OpenAIRE

Ahmed, Osman; Claydon, L.S.; Ribeiro, D.C.; Arumugam, A.; Higgs, C.; Baxter, G.D.

2013-01-01

Social media websites play a prominent role in modern society, and the most popular of these websites is Facebook. Increasingly, physiotherapy clinics have begun to utilize Facebook in order to create pages to publicize their services. There are many factors to consider in the planning, implementing, and maintenance of Facebook pages for physiotherapy clinics, including ethical and privacy issues. The primary purpose of creating a page must be clearly defined, with dedicated clinicians given ...

Knowledge, attitudes and clinical practice of blood products prescribers in Niamey.

Science.gov (United States)

Mayaki, Z; Kabo, R; Moutschen, M; Albert, A; Dardenne, N; Sondag, D; Gérard, C

2016-05-01

The lack of traceability and monitoring of blood donors and transfused patients constitute a barrier to the most basic rules of haemovigilance and overall good transfusion practices. This study draws up an inventory of knowledge, attitudes and clinical practice of blood prescribers in Niamey. A questionnaire was administered to 180 prescribers of blood products in Niamey in 2011. Questions were related to basic informations on blood transfusion and clinical use of blood. Analyses were performed using SAS 9.3 version. The sample consisted of 180 respondents from several professional categories: 51 physicians (28.33%), 10 medical students (5.56%), 84 nurses (46.67%), 15 anaesthesiologist assistant (8.33%) and 20 midwives (11.11%). Among these, 22.2% received training in blood transfusion safety. Half of the respondents (50.8%) got between 50 and 75% of correct answers, 45.8% got less than 50% correct while 3.35% scored more than 75% correct answers. The overall quality of responses was higher among physicians compared to other prescribers (Ptransfusion safety (Ptransfusion practices is necessary for prescribers of blood products. Accompanying measures to improve transfusion practice must be considered or strengthened through assessments, knowledge update/upgrade (regular, ongoing training) and establishment of active and motivated hospital transfusion committees. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Moving oncolytic viruses into the clinic: clinical-grade production, purification, and characterization of diverse oncolytic viruses

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Guy Ungerechts

2016-01-01

Full Text Available Oncolytic viruses (OVs are unique anticancer agents based on their pleotropic modes of action, which include, besides viral tumor cell lysis, activation of antitumor immunity. A panel of diverse viruses, often genetically engineered, has advanced to clinical investigation, including phase 3 studies. This diversity of virotherapeutics not only offers interesting opportunities for the implementation of different therapeutic regimens but also poses challenges for clinical translation. Thus, manufacturing processes and regulatory approval paths need to be established for each OV individually. This review provides an overview of clinical-grade manufacturing procedures for OVs using six virus families as examples, and key challenges are discussed individually. For example, different virus features with respect to particle size, presence/absence of an envelope, and host species imply specific requirements for measures to ensure sterility, for handling, and for determination of appropriate animal models for toxicity testing, respectively. On the other hand, optimization of serum-free culture conditions, increasing virus yields, development of scalable purification strategies, and formulations guaranteeing long-term stability are challenges common to several if not all OVs. In light of the recent marketing approval of the first OV in the Western world, strategies for further upscaling OV manufacturing and optimizing product characterization will receive increasing attention.

Moving oncolytic viruses into the clinic: clinical-grade production, purification, and characterization of diverse oncolytic viruses.

Science.gov (United States)

Ungerechts, Guy; Bossow, Sascha; Leuchs, Barbara; Holm, Per S; Rommelaere, Jean; Coffey, Matt; Coffin, Rob; Bell, John; Nettelbeck, Dirk M

2016-01-01

Oncolytic viruses (OVs) are unique anticancer agents based on their pleotropic modes of action, which include, besides viral tumor cell lysis, activation of antitumor immunity. A panel of diverse viruses, often genetically engineered, has advanced to clinical investigation, including phase 3 studies. This diversity of virotherapeutics not only offers interesting opportunities for the implementation of different therapeutic regimens but also poses challenges for clinical translation. Thus, manufacturing processes and regulatory approval paths need to be established for each OV individually. This review provides an overview of clinical-grade manufacturing procedures for OVs using six virus families as examples, and key challenges are discussed individually. For example, different virus features with respect to particle size, presence/absence of an envelope, and host species imply specific requirements for measures to ensure sterility, for handling, and for determination of appropriate animal models for toxicity testing, respectively. On the other hand, optimization of serum-free culture conditions, increasing virus yields, development of scalable purification strategies, and formulations guaranteeing long-term stability are challenges common to several if not all OVs. In light of the recent marketing approval of the first OV in the Western world, strategies for further upscaling OV manufacturing and optimizing product characterization will receive increasing attention.

Eating dysfunction associated with oromandibular dystonia: clinical characteristics and treatment considerations

Directory of Open Access Journals (Sweden)

Singer Carlos

2006-12-01

Full Text Available Abstract Background In oromandibular dystonia (OMD abnormal repetitive contractions of masticatory, facial, and lingual muscles as well as the presence of orobuccolingual (OBL dyskinesias may interfere with the appropriate performance of tasks such as chewing and swallowing leading to significant dysphagia and weight loss. We present here the clinical characteristics and treatment variables of a series of patients that developed an OMD-associated eating dysfunction. Methods We present a series of patients diagnosed and followed-up at the Movement Disorders Clinic of the Department of Neurology of University of Miami, Miller School of Medicine over a 10-year period. Patients were treated with botulinum toxin injections according to standard methods. Results Five out of 32 (15.6% OMD patients experienced symptoms of eating dysfunction associated with OMD. Significant weight loss was reported in 3/5 patients (ranged for 13–15 lbs. Two patients regained the lost weight after treatment and one was lost to follow-up. Tetrabenazine in combination with other antidystonic medication and/or botulinum toxin injections provided substantial benefit to the patients with dysphagia caused by OMD. Conclusion Dystonic eating dysfunction may occasionally complicate OMD leading to weight loss. Its adequate characterization at the time of history taking and clinical examination should be part of outcome measurements of the anti-dystonic treatment in clinical practice.

In vitro cumulative gas production techniques: history, methodological considerations and challenges

NARCIS (Netherlands)

Rymer, C.; Huntington, J.A.; Williams, B.A.; Givens, D.I.

2005-01-01

Methodology used to measure in vitro gas production is reviewed to determine impacts of sources of variation on resultant gas production profiles (GPP). Current methods include measurement of gas production at constant pressure (e.g., use of gas tight syringes), a system that is inexpensive, but may

Real-Time PCR in Clinical Microbiology: Applications for Routine Laboratory Testing

Science.gov (United States)

Espy, M. J.; Uhl, J. R.; Sloan, L. M.; Buckwalter, S. P.; Jones, M. F.; Vetter, E. A.; Yao, J. D. C.; Wengenack, N. L.; Rosenblatt, J. E.; Cockerill, F. R.; Smith, T. F.

2006-01-01

Real-time PCR has revolutionized the way clinical microbiology laboratories diagnose many human microbial infections. This testing method combines PCR chemistry with fluorescent probe detection of amplified product in the same reaction vessel. In general, both PCR and amplified product detection are completed in an hour or less, which is considerably faster than conventional PCR detection methods. Real-time PCR assays provide sensitivity and specificity equivalent to that of conventional PCR combined with Southern blot analysis, and since amplification and detection steps are performed in the same closed vessel, the risk of releasing amplified nucleic acids into the environment is negligible. The combination of excellent sensitivity and specificity, low contamination risk, and speed has made real-time PCR technology an appealing alternative to culture- or immunoassay-based testing methods for diagnosing many infectious diseases. This review focuses on the application of real-time PCR in the clinical microbiology laboratory. PMID:16418529

Clinical and para-clinical tests in the routine examination of headache patients

DEFF Research Database (Denmark)

Friberg, L; Sandrini, G; Jänig, W

2000-01-01

Para-clinical examinations in the diagnosis and treatment control of headache patients vary considerably between clinics and headache centers. Among the neurological societies in Europe there has been a consensus that some common procedures and recommendations should be created. In the Fall of 19...

Improving lactate metabolism in an intensified CHO culture process: productivity and product quality considerations.

Science.gov (United States)

Xu, Sen; Hoshan, Linda; Chen, Hao

2016-11-01

In this study, we discussed the development and optimization of an intensified CHO culture process, highlighting medium and control strategies to improve lactate metabolism. A few strategies, including supplementing glucose with other sugars (fructose, maltose, and galactose), controlling glucose level at Productivity and product quality attributes differences between batch, fed-batch, and concentrated fed-batch cultures were discussed. The importance of process and cell metabolism understanding when adapting the existing process to a new operational mode was demonstrated in the study.

Simple and multiple linear regression: sample size considerations.

Science.gov (United States)

Hanley, James A

2016-11-01

The suggested "two subjects per variable" (2SPV) rule of thumb in the Austin and Steyerberg article is a chance to bring out some long-established and quite intuitive sample size considerations for both simple and multiple linear regression. This article distinguishes two of the major uses of regression models that imply very different sample size considerations, neither served well by the 2SPV rule. The first is etiological research, which contrasts mean Y levels at differing "exposure" (X) values and thus tends to focus on a single regression coefficient, possibly adjusted for confounders. The second research genre guides clinical practice. It addresses Y levels for individuals with different covariate patterns or "profiles." It focuses on the profile-specific (mean) Y levels themselves, estimating them via linear compounds of regression coefficients and covariates. By drawing on long-established closed-form variance formulae that lie beneath the standard errors in multiple regression, and by rearranging them for heuristic purposes, one arrives at quite intuitive sample size considerations for both research genres. Copyright © 2016 Elsevier Inc. All rights reserved.

A systematic review assessing non-pharmacological conservative treatment studies for people with non-inflammatory multi-joint pain: clinical outcomes and research design considerations.

Science.gov (United States)

Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G

2018-03-01

To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).

The intelligent clinical laboratory as a tool to increase cancer care management productivity.

Science.gov (United States)

Mohammadzadeh, Niloofar; Safdari, Reza

2014-01-01

Studies of the causes of cancer, early detection, prevention or treatment need accurate, comprehensive, and timely cancer data. The clinical laboratory provides important cancer information needed for physicians which influence clinical decisions regarding treatment, diagnosis and patient monitoring. Poor communication between health care providers and clinical laboratory personnel can lead to medical errors and wrong decisions in providing cancer care. Because of the key impact of laboratory information on cancer diagnosis and treatment the quality of the tests, lab reports, and appropriate lab management are very important. A laboratory information management system (LIMS) can have an important role in diagnosis, fast and effective access to cancer data, decrease redundancy and costs, and facilitate the integration and collection of data from different types of instruments and systems. In spite of significant advantages LIMS is limited by factors such as problems in adaption to new instruments that may change existing work processes. Applications of intelligent software simultaneously with existing information systems, in addition to remove these restrictions, have important benefits including adding additional non-laboratory-generated information to the reports, facilitating decision making, and improving quality and productivity of cancer care services. Laboratory systems must have flexibility to change and have the capability to develop and benefit from intelligent devices. Intelligent laboratory information management systems need to benefit from informatics tools and latest technologies like open sources. The aim of this commentary is to survey application, opportunities and necessity of intelligent clinical laboratory as a tool to increase cancer care management productivity.

Sustainability, natural and organic cosmetics: consumer, products, efficacy, toxicological and regulatory considerations

Directory of Open Access Journals (Sweden)

Bruno Fonseca-Santos

2015-03-01

Full Text Available The interest in sustainable products has increased along the years, since the choice of products, packaging and production processes have a great impact on the environment. These products are classified by regulatory agencies in different categories, aggregating advantages to the product and increasing the demand by consumers. However, there is no harmonization in guidelines of these certifying agencies and each cosmetic industry formulates their product and packaging in a more rational way, which causes less damage to the environment. Many cosmetic products have in their formulation natural products that perform a specific biological function, but these products should be evaluated on efficacy and toxicological aspects. The aim of this article is to approach sustainability, natural and organic cosmetics, considering the consumer and the efficacy, toxicological and regulatory aspects.

Some considerations on robotics for environmental friendliness

International Nuclear Information System (INIS)

Pin, F.G.

1993-01-01

This paper presents a series of considerations regarding the use and potential of robotic devices for supporting humans in a variety of tasks, while maintaining, if not improving, environmental friendliness. One of the main considerations brought forward here relates to the type of human-support functions which the robots are, or will be, expected to perform, and from this, a clear differentiation appears between robots designed to replace humans in environments that were engineered in the past for best human functionality, and robots designed to take functions in the future, in environments which could be better engineered for large-scale human-robot synergy. Other considerations discussed involve the ''life-cycle'' cleanliness of robotic systems, including the materials needs for their construction, their operation, their disposal and, more importantly, their energy consumption which will impact the cycle of natural resources utilization. These considerations are discussed using a variety of possible robotic systems applications in contexts varied as manufacturing, energy recovery and production, emergency situations handling, traffic improvement, waste management, agriculture, and space exploration. In all these applications, the operation costs and complexity of the robots seem to vary in inverse proportion to the amount of engineering that is feasible to make the task environment more robot-friendly, but with no seemingly direct impact on the potential for environmental friendliness of the robots

Some considerations on robotics for environmental friendliness

Energy Technology Data Exchange (ETDEWEB)

Pin, F.G.

1993-12-01

This paper presents a series of considerations regarding the use and potential of robotic devices for supporting humans in a variety of tasks, while maintaining, if not improving, environmental friendliness. One of the main considerations brought forward here relates to the type of human-support functions which the robots are, or will be, expected to perform, and from this, a clear differentiation appears between robots designed to replace humans in environments that were engineered in the past for best human functionality, and robots designed to take functions in the future, in environments which could be better engineered for large-scale human-robot synergy. Other considerations discussed involve the ``life-cycle`` cleanliness of robotic systems, including the materials needs for their construction, their operation, their disposal and, more importantly, their energy consumption which will impact the cycle of natural resources utilization. These considerations are discussed using a variety of possible robotic systems applications in contexts varied as manufacturing, energy recovery and production, emergency situations handling, traffic improvement, waste management, agriculture, and space exploration. In all these applications, the operation costs and complexity of the robots seem to vary in inverse proportion to the amount of engineering that is feasible to make the task environment more robot-friendly, but with no seemingly direct impact on the potential for environmental friendliness of the robots.

Clinical evaluation of marketed orthodontic products: are researchers behind the times? A meta-epidemiological study

Directory of Open Access Journals (Sweden)

Jadbinder Seehra

2017-05-01

Full Text Available Abstract Background The role of marketing and industry in the treatment decisions of orthodontists has received increasing attention in recent years with clinical research typically undertaken subsequent to established use of these devices and often failing to confirm the promise of manufacturers’ claims. This meta-epidemiological study was undertaken to assess the proportion of clinical trials in orthodontics evaluating commercially marketed products and to evaluate the direction of the results of these studies. Methods Electronic searching was undertaken to identify randomized controlled trials (RCTs published over a 5-year period (1 January 2012 to 31 December 2016. Data obtained included the type of marketed intervention, direction of effect and declaration of both industry sponsorship and conflict of interest. Results Eighty-four RCTs published in 23 scientific journals were included with the highest percentage in the American Journal of Dentofacial Orthopedics (AJO-DO (23.8%, followed by the European Journal of Orthodontics (EJO (14.3%, Journal of Orthodontics (JO (10.7% and Angle Orthodontist (AO (10.7%. Overall, 45% (38/84 of clinical trials assessed involved analysis of marketed products after their introduction. Interventions to improve oral health or circumvent the risk of iatrogenic damage, such as white spot lesions, were most commonly assessed (15.8%, with the relative merits of non-surgical adjuncts (14.1% and other orthodontic auxiliaries (13.1% also frequently evaluated. In 44% of RCTs, a positive effect of the marketed intervention was not reported. Industry sponsorship of the research was declared in 9.5% RCTs. No significant associations between the direction of the effect and both declaration of industry sponsorship (p = 0.56 and conflict of interest (p = 0.96 were detected. Moreover, for marketed and non-marketed products, no significant associations for both declaration of industry sponsorship (p = 0.44 and

Slime production and antibiotic susceptibility in staphylococci isolated from clinical samples

Directory of Open Access Journals (Sweden)

Seza Arslan

2007-02-01

Full Text Available A total of 187 isolates from several clinical specimens were identified to species level as 129 Staphylococcus aureus strains and 58 coagulase-negative staphylococci (CNS strains by the API Staph System (Biomerieux. Slime production was detected both by the conventional Christensen's method as well as by the Congo red agar method. Seventy-two strains of staphylococci isolates (38.5% were found to be slime producers by Christensen's test tube method whereas 58 strains (31% were slime positive with Congo red agar method. There was no statistically significant difference between the two methods for the detection of slime production (P > 0.05. Susceptibility of isolates against antimicrobial agents was tested by the disk diffusion method. Staphylococcal species had resistance to one or more antibiotics. Among the various antimicrobial agents, oxacillin (71.1% and erythromycin (47.1% showed higher resistance than most of the agents used against all isolates. Oxacillin resistant S. aureus (ORSA and oxacillin resistant coagulase-negative staphylococci (ORCNS, 97 (75.2% and 36 (62.1% respectively were frequently observed in strains isolated from clinical materials. Among the ORSA strains, two strains were resistant to vancomycin. Moreover, 96 (74.4% of 129 S. aureus strains were positive for blactamase enzyme. However, 78 (81.25% of 96 b-lactamase positive S. aureus strains were b-lactamase positive ORSA isolates, but none of them had vancomycin resistance.

Evolution of design considerations in complex craniofacial reconstruction using patient-specific implants.

Science.gov (United States)

Peel, Sean; Bhatia, Satyajeet; Eggbeer, Dominic; Morris, Daniel S; Hayhurst, Caroline

2017-06-01

Previously published evidence has established major clinical benefits from using computer-aided design, computer-aided manufacturing, and additive manufacturing to produce patient-specific devices. These include cutting guides, drilling guides, positioning guides, and implants. However, custom devices produced using these methods are still not in routine use, particularly by the UK National Health Service. Oft-cited reasons for this slow uptake include the following: a higher up-front cost than conventionally fabricated devices, material-choice uncertainty, and a lack of long-term follow-up due to their relatively recent introduction. This article identifies a further gap in current knowledge - that of design rules, or key specification considerations for complex computer-aided design/computer-aided manufacturing/additive manufacturing devices. This research begins to address the gap by combining a detailed review of the literature with first-hand experience of interdisciplinary collaboration on five craniofacial patient case studies. In each patient case, bony lesions in the orbito-temporal region were segmented, excised, and reconstructed in the virtual environment. Three cases translated these digital plans into theatre via polymer surgical guides. Four cases utilised additive manufacturing to fabricate titanium implants. One implant was machined from polyether ether ketone. From the literature, articles with relevant abstracts were analysed to extract design considerations. In all, 19 frequently recurring design considerations were extracted from previous publications. Nine new design considerations were extracted from the case studies - on the basis of subjective clinical evaluation. These were synthesised to produce a design considerations framework to assist clinicians with prescribing and design engineers with modelling. Promising avenues for further research are proposed.

Sensibility of Teeth Having Based versus Non-Based Amalgam Restorations: A Clinical Study.

Science.gov (United States)

1983-04-01

50:129-34, Apr. 1980. 102. Morrant, G. Dental instrumentation and pulpal injury: clinical considerations. Brit. Endodont . Soc. J., 10:3-8, 55-63...on the teeth are suspected mechanisms. In general, the effects of rotary cavity preparations--cutting of dentinal tubules and odontoblastic processes...aspiration of odontoblasts is of no consequence to the pulp providing the cells in the cell rich zone are intact. The idea that heat production from rotary

Erythroid cells in vitro: from developmental biology to blood transfusion products.

Science.gov (United States)

Migliaccio, Anna Rita; Whitsett, Carolyn; Migliaccio, Giovanni

2009-07-01

Red blood cells (RBCs) transfusion plays a critical role in numerous therapies. Disruption of blood collection by political unrest, natural disasters and emerging infections and implementation of restrictions on the use of erythropoiesis-stimulating agents in cancer may impact blood availability in the near future. These considerations highlight the importance of developing alternative blood products. Knowledge about the processes that control RBC production has been applied to the establishment of culture conditions allowing ex-vivo generation of RBCs in numbers close to those (2.5 x 10 cells/ml) present in a transfusion, from cord blood, donated blood units or embryonic stem cells. In addition, experimental studies demonstrate that such cells protect mice from lethal bleeding. Therefore, erythroid cells generated ex vivo may be suitable for transfusion provided they can be produced safely in adequate numbers. However, much remains to be done to translate a theoretical production of approximately 2.5 x 10 RBCs in the laboratory into a 'clinical grade production process'. This review summarizes the state-of-the-art in establishing ex-vivo culture conditions for erythroid cells and discusses the most compelling issues to be addressed to translate this progress into a clinical grade transfusion product.

Heterogeneous production of proteases from Brazilian clinical isolates of Pseudomonas aeruginosa.

Science.gov (United States)

Galdino, Anna Clara M; Viganor, Lívia; Ziccardi, Mariangela; Nunes, Ana Paula F; Dos Santos, Kátia R N; Branquinha, Marta H; Santos, André L S

2017-12-01

Pseudomonas aeruginosa is an important human pathogen that causes severe infections in a wide range of immunosuppressed patients. Herein, we evaluated the proteolytic profiles of 96 Brazilian clinical isolates of P. aeruginosa recovered from diverse anatomical sites. Cell-associated and extracellular proteases were evidenced by gelatin-SDS-PAGE and by the cleavage of soluble gelatin. Elastase was measured by using the peptide substrate N-succinyl-Ala-Ala-Ala-p-nitroanilide. The prevalence of elastase genes (lasA and lasB) was evaluated by PCR. Bacterial extracts were initially applied on gelatin-SDS-PAGE and the results revealed four distinct zymographic profiles as follows: profile I (composed by bands of 145, 118 and 50kDa), profile II (118 and 50kDa), profile III (145kDa) and profile IV (118kDa). All the proteolytic enzymes were inhibited by EDTA, identifying them as metalloproteases. The profile I was the most detected in both cellular (79.2%) and extracellular (84.4%) extracts. Overall, gelatinase and elastase activities measured in the spent culture media were significantly higher (around 2-fold) compared to the cellular extracts and the production level varied according to the site of bacterial isolation. For instance, tracheal secretion isolates produced elevated amount of gelatinase and elastase measured in both cellular and extracellular extracts. The prevalence of elastase genes revealed that 100% isolates were lasB-positive and 85.42% lasA-positive. Some positive/negative correlations were showed concerning the production of gelatinase, elastase, isolation site and antimicrobial susceptibility. The protease production was highly heterogeneous in Brazilian clinical isolates of P. aeruginosa, which corroborates the genomic/metabolic versatility of this pathogen. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Prescription and Cost Consideration at a Diabetic Clinic in Ibadan ...

African Journals Online (AJOL)

opsig

SUMMARY. Diabetes mellitus is associated with high morbidity and mortality. The high cost of treatment is a major concern to both physicians and patients. This study assessed pattern and cost of drugs prescribed at a diabetic clinic, and identified the commonest reasons militating against adherence to therapy.The study ...

Training-Based Interventions in Motor Rehabilitation after Stroke: Theoretical and Clinical Considerations

Directory of Open Access Journals (Sweden)

Annette Sterr

2004-01-01

Full Text Available Basic neuroscience research on brain plasticity, motor learning and recovery has stimulated new concepts in neurological rehabilitation. Combined with the development of set methodological standards in clinical outcome research, these findings have led to a double-paradigm shift in motor rehabilitation: (a the move towards evidence-based procedures for the assessment of clinical outcome & the employment of disablement models to anchor outcome parameters, and (b the introduction of practice-based concepts that are derived from testable models that specify treatment mechanisms. In this context, constraint-induced movement therapy (CIT has played a catalytic role in taking motor rehabilitation forward into the scientific arena. As a theoretically founded and hypothesis-driven intervention, CIT research focuses on two main issues. The first issue is the assessment of long-term clinical benefits in an increasing range of patient groups, and the second issue is the investigation of neuronal and behavioural treatment mechanisms and their interactive contribution to treatment success. These studies are mainly conducted in the research environment and will eventually lead to increased treatment benefits for patients in standard health care. However, gradual but presumably more immediate benefits for patients may be achieved by introducing and testing derivates of the CIT concept that are more compatible with current clinical practice. Here, we summarize the theoretical and empirical issues related to the translation of research-based CIT work into the clinical context of standard health care.

Health and safety in clinical laboratories in developing countries: safety considerations.

Science.gov (United States)

Ejilemele, A A; Ojule, A C

2004-01-01

Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.

Choosing preclinical study models of diabetic retinopathy: key problems for consideration

Science.gov (United States)

Mi, Xue-Song; Yuan, Ti-Fei; Ding, Yong; Zhong, Jing-Xiang; So, Kwok-Fai

2014-01-01

Diabetic retinopathy (DR) is the most common complication of diabetes mellitus in the eye. Although the clinical treatment for DR has already developed to a relative high level, there are still many urgent problems that need to be investigated in clinical and basic science. Currently, many in vivo animal models and in vitro culture systems have been applied to solve these problems. Many approaches have also been used to establish different DR models. However, till now, there has not been a single study model that can clearly and exactly mimic the developmental process of the human DR. Choosing the suitable model is important, not only for achieving our research goals smoothly, but also, to better match with different experimental proposals in the study. In this review, key problems for consideration in choosing study models of DR are discussed. These problems relate to clinical relevance, different approaches for establishing models, and choice of different species of animals as well as of the specific in vitro culture systems. Attending to these considerations will deepen the understanding on current study models and optimize the experimental design for the final goal of preventing DR. PMID:25429204

Design considerations and operational performance of Anaerobic Digester: A Review

Directory of Open Access Journals (Sweden)

Muzaffar Ahmad Mir

2016-04-01

Full Text Available Due to the decline in fossil fuel reservoirs, the researchers emphasized more on the production of biogas from organic waste. Producing the renewable energy from biodegradable waste helps to overcome the energy crisis and solid waste management, done by anaerobic digestion. Anaerobic digestion is controlled breakdown of organic matter into methane gas (60%, carbon dioxide (40%, trace components along with digested used as soil conditioner. However there is vast dearth of literature regarding the design considerations. The batch digestion system yields a cost-effective and economically viable means for conversion of the food waste to useful energy. It is therefore recommended that such process can be increasingly employed in order to get and simultaneously protect the environment .This paper aims to draw key analysis and concern about the design considerations, analysis of gas production, substrates and inoculums utilization, uses and impacts of biogas.

Biosimilars: from technical to pharmacoeconomic considerations. 30th Rencontres Nationales de Pharmacologie et Recherche clinique pour l'Innovation et l'Evaluation des Technologies de Santé. Tables rondes.

Science.gov (United States)

Girault, Danièle; Trouvin, Jean-Hugues; Blachier-Poisson, Corinne; Gary, François; Laloye, Didier; Bergmann, Jean-François; Casadevall, Nicole; Delval, Cécile; De Sahb Berkovitch, Rima; Fagon, Jean-Yves; Gersberg, Marta; Lassale, Catherine; Lechat, Philippe; Le Jeunne, Claire; Montastruc, Jean-Louis; Prugnaud, Jean-Louis; Ratignier-Carbonneil, Christelle; Rey-Coquais, Cécile

2015-01-01

A biosimilar is a biological medicinal product claimed to be similar to a reference biological medicinal product. Its development plan includes studies comparing it with the reference product in order to confirm its similarity in terms of quality, preclinical safety, clinical efficacy, and clinical safety, including immunogenicity. Biosimilars differ from generics both in their molecular complexity and in the specific requirements that apply to them. Since patents on many biological medicinal products will expire within the next 5 years in major therapeutic areas such as oncology, rheumatology and gastroenterology and as those products are so costly to the French national health insurance system, the availability of biosimilars would have a considerable economic impact. The round table has issued a number of recommendations intended to ensure that the upcoming arrival of biosimilars on the market is a success, in which prescribing physicians would have a central role in informing and reassuring patients, an efficient monitoring of the patients treated with biologicals would be set up and time to market for biosimilars would be speeded up. © 2015 Société Française de Pharmacologie et de Thérapeutique.

Considerations in setting up and planning a graft processing facility.

Science.gov (United States)

Koh, Mickey B C

2017-12-01

The graft processing facility forms one of the core components of a clinical haematopoietic stem cell transplant program. The quality of a graft is instrumental in leading to consistent and reproducible outcomes of engraftment and other parameters. As such, meticulous planning and consideration is required and will include core elements including physical design and clinical correlates. The successful running of such a facility depends on an overarching quality program and adherence to local and international regulatory guidelines. Copyright © 2017 King Faisal Specialist Hospital & Research Centre. Published by Elsevier B.V. All rights reserved.

Incorporation of Scribes Into the Inflammatory Bowel Disease Clinic Improves Quality of Care and Physician Productivity.

Science.gov (United States)

Ewelukwa, Ofor; Perez, Roque; Carter, Lee Ellen; Fernandez, Alyka; Glover, Sarah

2018-02-15

Electronic health records (EHRs), despite their positive attributes, increase physician workload and decrease efficiency. The aim of this study was to evaluate the impact of scribes in the Inflammatory Bowel Disease Clinic on improvement of the physician-patient relationship, physician productivity, clinical efficiency, and achievement of some Physician Quality Reporting System (PQRS) metrics. We analyzed of pre- and postscribe data between fiscal years 2015 (FY15) and 2016 (FY16) using data from patients at the Inflammatory Bowel Clinic at the University of Florida. The main outcomes were patient satisfaction scores (PSS), qualitative physician interview, clinic appointment lengths, work relative value units (wRVUs), level of coding, revenue, and PQRS data on bone density screening and vaccination. PSS increased from 6.8/10 to 9.2/10 (P stress decreased. Clinic visits increased by 76, leading to an increase in work RVUs by 332.55, total charges billed by $71,439, and total charges collected by $27,387 between the first quarters of FY15 and FY16. The extra revenue for the first quarter was 536% higher than the salary of the scribe for the same period ($4302.84). There was a 1.8-fold increase in referrals for bone density scans and 2.9-fold and 4.8-fold increases in vaccination rates for influenza and pneumonia, respectively. The use of scribes improved the physician-patient relationship, clinical efficiency, physician productivity, bone density screening, and vaccinations for flu and pneumonia. If adopted by health systems, it may lead to significant cost savings and improved clinical outcomes.

A new paradigm for HIV care: ethical and clinical considerations.

Science.gov (United States)

Noring, S; Dubler, N N; Birkhead, G; Agins, B

2001-05-01

Although dramatic advances in clinical treatment have greatly improved the lives of many people with HIV/AIDS, many other patients do not have information about or access to these treatments because of health care providers' presumptive judgments about patients' ability to adhere to medical regimens. The authors contend that with sufficient support and education most patients, even those with difficult social and medical problems, can be helped to initiate and maintain HIV treatment in accordance with current clinical standards. This commentary delineates a new paradigm for HIV care in which patients and providers collaborate on individualized plans to establish patients' readiness for treatment, ensure maintenance of treatment, and make use of the social services necessary to accomplish these goals. Providers have an ethical responsibility to do everything possible to see that patients who might benefit from new HIV treatments have a fair opportunity to do so, and health systems have a responsibility to facilitate this process. Substantial progress toward meeting these responsibilities can be made within the current health care environment.

Clinical and laboratory evaluation of adrenal dysfunction

International Nuclear Information System (INIS)

Ashkar, F.S.; Fishman, L.M.

1983-01-01

Because of their special physical and chemical properties, the adrenal secretory products were among the first hormonal substances to be measured by methods other than bioassay. Over the past several years, the development of sensitive and specific methods of hormone assay dependent on the use of radionuclides has revolutionized investigative and clinical endocrinology. While the capacity of defining most abnormalities of adrenal function antedates hormone measurement and adrenal imaging utilizing radioisotopes, the availability of such methods has greatly facilitated and made more precise the diagnostic approach to patients with suspected adrenal dysfunction. As an example of how clinical and laboratory considerations can be integrated into a rational approach to the diagnosis of adrenal disease, the problem of suspected adrenal hyperfunction is analyzed in light of current understanding of its pathophysiology. Reflection demonstrates that suspected primary aldosteronism and adrenal insufficiency are equally amenable to such an approach

Clinical considerations for neutron capture therapy of brain tumors

International Nuclear Information System (INIS)

Madoc-Jones, H.; Wazer, D.E.; Zamenhof, R.G.; Harling, O.K.; Bernard, J.A. Jr.

1990-01-01

The radiotherapeutic management of primary brain tumors and metastatic melanoma in brain has had disappointing clinical results for many years. Although neutron capture therapy was tried in the US in the 1950s and 1960s, the results were not as hoped. However, with the newly developed capability to measure boron concentrations in blood and tissue both quickly and accurately, and with the advent of epithermal neutron beams obviating the need for scalp and skull reflection, it should not be possible to mount such a clinical trial of NCT again and avoid serious complications. As a prerequisite, it will be important to demonstrate the differential uptake of boron compound in brain tumor as compared with normal brain and its blood supply. If this can be done, then a trial of boron neutron capture therapy for brain tumors should be feasible. Because boronated phenylalanine has been demonstrated to be preferentially taken up by melanoma cells through the biosynthetic pathway for melanin, there is special interest in a trial of boron neutron capture therapy for metastatic melanoma in brain. Again, the use of an epithermal beam would make this a practical possibility. However, because any epithermal (or thermal) beam must contain a certain contaminating level of gamma rays, and because even a pure neutron beam cases gamma rays to be generated when it interacts with tissue, they think that it is essential to deliver treatments with an epithermal beam for boron neutron capture therapy in fractions in order to minimize the late-effects of low-LET gamma rays in the normal tissue

Commercial considerations in tissue engineering.

Science.gov (United States)

Mansbridge, Jonathan

2006-10-01

Tissue engineering is a field with immense promise. Using the example of an early tissue-engineered skin implant, Dermagraft, factors involved in the successful commercial development of devices of this type are explored. Tissue engineering has to strike a balance between tissue culture, which is a resource-intensive activity, and business considerations that are concerned with minimizing cost and maximizing customer convenience. Bioreactor design takes place in a highly regulated environment, so factors to be incorporated into the concept include not only tissue culture considerations but also matters related to asepsis, scaleup, automation and ease of use by the final customer. Dermagraft is an allogeneic tissue. Stasis preservation, in this case cryopreservation, is essential in allogeneic tissue engineering, allowing sterility testing, inventory control and, in the case of Dermagraft, a cellular stress that may be important for hormesis following implantation. Although the use of allogeneic cells provides advantages in manufacturing under suitable conditions, it raises the spectre of immunological rejection. Such rejection has not been experienced with Dermagraft. Possible reasons for this and the vision of further application of allogeneic tissues are important considerations in future tissue-engineered cellular devices. This review illustrates approaches that indicate some of the criteria that may provide a basis for further developments. Marketing is a further requirement for success, which entails understanding of the mechanism of action of the procedure, and is illustrated for Dermagraft. The success of a tissue-engineered product is dependent on many interacting operations, some discussed here, each of which must be performed simultaneously and well.

Development of a surrogate angiogenic potency assay for clinical-grade stem cell production.

Science.gov (United States)

Lehman, Nicholas; Cutrone, Rochelle; Raber, Amy; Perry, Robert; Van't Hof, Wouter; Deans, Robert; Ting, Anthony E; Woda, Juliana

2012-09-01

Clinical results from acute myocardial infarction (AMI) patients treated with MultiStem®, a large-scale expanded adherent multipotent progenitor cell population (MAPC), have demonstrated a strong safety and benefit profile for these cells. The mechanism of benefit with MAPC treatment is a result, in part, of its ability to induce neovascularization through trophic support. Production of clinical-grade stem cell products requires the development of lot-release criteria based on potency assays that directly reflect the fundamental mechanistic pathway underlying the therapeutic response to verify manufacturing process consistency and product potency. Using an in vitro endothelial tube formation assay, a potency assay has been developed that reflects MAPC pro-angiogenic activity. Serum-free conditioned media collected from MAPC culture induced endothelial tube formation. A proteomic survey of angiogenic factors produced by the cells in vitro revealed candidate factors linked to angiogenic potency. Three cytokines, chemokine (C-X-C motif) ligand 5 (CXCL5), interleukin 8 (IL-8) and vascular endothelial growth factor (VEGF), were required for this angiogenic activity. Depletion of any of these factors from the media prevented tube formation, while adding back increasing amounts of these cytokines into the depleted serum-free conditioned media established the lower limits of each of the cytokines required to induce angiogenesis. A necessary threshold of angiogenic factor expression was established using an in vitro angiogenesis assay. By correlating the levels of the cytokines required to induce tube formation in vitro with levels of the factors found in the spent media from manufacturing production runs, detection of these factors was identified as a surrogate potency assay with defined pass/fail criteria.

Academic versus Clinical Productivity of Cardiac Surgeons in the State of New York: Who Publishes More and Who Operates More.

Science.gov (United States)

Rosati, Carlo Maria; Gaudino, Mario; Vardas, Panos N; Weber, Daniel J; Blitzer, David; Hameedi, Fawad; Koniaris, Leonidas G; Girardi, Leonard N

2018-01-01

We investigated whether/how cardiac surgeons can be productive both academically and clinically. Using online resources (New York State Adult Cardiac Surgery database, SCOPUS), we collected individual clinical volumes (operations performed/year), academic metrics (ongoing publications, role as author), practice setting, and seniority for all cardiac surgeons in the State of New York from 1994 to 2011. Over time, individual clinical volumes decreased (median operations/year: 193 in 1995 vs 126 in 2010; P published more worked at hospitals with higher clinical volumes (Spearman's correlation coefficient: 0.16; P publishing at all; ∼45 per cent operating less, but publishing a little; ∼15 per cent clinically very productive (operating as much as the nonpublishers) and publishing a lot; and ∼1 per cent operating the least, but publishing the most.

Feasibility studies of radiation sterilization of some pharmaceutical products

International Nuclear Information System (INIS)

Gopal, N.G.S.; Rajagopalan, S.; Sharma, G.

1975-01-01

The paper deals with some studies carried out to evaluate the feasibility of radiation sterilization or treatment of some medical products and pharmaceuticals of immediate importance to their respective industries. The products include penicillin G sodium, ampicillin sodium, tetracyclin hydrochloride ointment,hydrocortisone acetate and its ointment, aqueous sodium chloride solutions (0.9 and 20%), fluorescein sodium strips, urea, ethylmorphine hydrochloride, aqueous solution of chlorobutanol and one of its commercial preparations, phenylmercuric nitrate and its aqueous solutions, aqueous solutions of methyl and propyl paraben, lactose, gum karaya, absorbent cotton and poly-(vinyl chloride) based medical products. The irradiated products have been examined for pharmacopoeial specifications wherever available. In general the products have been examined for changes in colour, pH, ultra-violet and infra-red absorption spectra. Thin-layer chromatographic analyses have been carried out to establish the purity of some of the irradiated products. The feasibility or otherwise of radiation sterilization or treatment of the various products from the physicochemical and microbiological (pharmacological) clinical considerations is also described. (author)

Probiotic Products in Canada with Clinical Evidence: What Can Gastroenterologists Recommend?

Directory of Open Access Journals (Sweden)

Gregor Reid

2008-01-01

Full Text Available Probiotics, defined as ‘live microorganisms, which when administered in adequate amounts, confer a health benefit on the host’, are finally becoming an option for gastroenterologists in Canada, after being available for many years in Japan, Europe and the United States of America. Unfortunately, Health Canada and the US Food and Drug Administration have not controlled the use of the term ‘probiotic’ or put into place United Nations and World Health Organization guidelines. The net result is that a host of products called ‘probiotics’ are available but are not truly probiotic. The aim of the present review was to discuss the rationale for probiotics in gastroenterology, and specifically examine which products are options for physicians in Canada, and which ones patients might be using. It is hoped that by clarifying what probiotics are, and the strengths and limitations of their use, specialists will be better placed to make recommendations on the role of these products in patient care. In due course, more clinically documented probiotics will emerge, some with therapeutic effects based on a better understanding of disease processes.

Pharmaceutical, biological, and clinical properties of botulinum neurotoxin type A products.

Science.gov (United States)

Frevert, Jürgen

2015-03-01

Botulinum neurotoxin injections are a valuable treatment modality for many therapeutic indications and have revolutionized the field of aesthetic medicine so that they are the leading cosmetic procedure performed worldwide. Studies show that onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA are comparable in terms of clinical efficacy. Differences between the products relate to the botulinum neurotoxin complexes, specific biological potency, and their immunogenicity. Protein complex size and molecular weight have no effect on biological activity, stability, distribution, or side effect profile. Complexing proteins and inactive toxin (toxoid) content increase the risk of neutralizing antibody formation, which can cause secondary treatment failure, particularly in chronic disorders that require frequent injections and long-term treatment. These attributes could lead to differences in therapeutic outcomes, and, given the widespread aesthetic use of these three neurotoxin products, physicians should be aware of how they differ to ensure their safe and effective use.

CONSIDERATION OF "VISUAL PRODUCT" AS A NEW PRODUCT EXCEPT FROM ECONOMIC AND GOOD QUALITY IN THE RESPONSIBILITY OF SPORTING PRODUCTS

OpenAIRE

Abdurrahman Kepoğlu

2017-01-01

As it is known, economical products are divided into two main components (goods/services). The developing technology has restructured its geographical position. The storage capability of sporting products makes it necessary to define the concept of "visual product". In our study, the general scanning model, which is one of the descriptive research methods, is used (Karasar 2009). In the frame of this descriptive scanning method, a theoretical-analytical method has been used focusing on writin...

Extracellular membrane vesicles in blood products-biology and clinical relevance

Directory of Open Access Journals (Sweden)

Emilija Krstova Krajnc

2016-01-01

Full Text Available Extracellular membrane vesicles are fragments shed from plasma membranes off all cell types that are undergoing apoptosis or are being subjected to various types of stimulation or stress.  Even in the process of programmed cell death (apoptosis, cell fall apart of varying size vesicles. They expose phosphatidylserine (PS on the outer leaflet of their membrane, and bear surface membrane antigens reflecting their cellular origin. Extracellular membrane vesicles have been isolated from many types of biological fluids, including serum, cerebrospinal fluid, urine, saliva, tears and conditioned culture medium. Flow cytometry is one of the many different methodological approaches that have been used to analyze EMVs. The method attempts to characterize the EMVs cellular origin, size, population, number, and structure. EMVs are present and accumulate in blood products (erythrocytes, platelets as well as in fresh frozen plasma during storage. The aim of this review is to highlight the importance of extracellular vesicles as a cell-to-cell communication system and the role in the pathogenesis of different diseases. Special emphasis will be given to the implication of extracellular membrane vesicles in blood products and their clinical relevance. Although our understanding of the role of  EMVs in disease is far from comprehensive, they display promise as biomarkers for different diseases in the future and also as a marker of quality and safety in the quality control of blood products.

Productivity and time use during occupational therapy and nutrition/dietetics clinical education: a cohort study.

Directory of Open Access Journals (Sweden)

Sylvia Rodger

Full Text Available BACKGROUND: Currently in the Australian higher education sector higher productivity from allied health clinical education placements is a contested issue. This paper will report results of a study that investigated output changes associated with occupational therapy and nutrition/dietetics clinical education placements in Queensland, Australia. Supervisors' and students' time use during placements and how this changes for supervisors compared to when students are not present in the workplace is also presented. METHODOLOGY/PRINCIPAL FINDINGS: A cohort design was used with students from four Queensland universities, and their supervisors employed by Queensland Health. There was an increasing trend in the number of occasions of service delivered when the students were present, and a statistically significant increase in the daily mean length of occasions of service delivered during the placement compared to pre-placement levels. CONCLUSIONS/SIGNIFICANCE: A novel method for estimating productivity and time use changes during clinical education programs for allied health disciplines has been applied. During clinical education placements there was a net increase in outputs, suggesting supervisors engage in longer consultations with patients for the purpose of training students, while maintaining patient numbers. Other activities were reduced. This paper is the first time these data have been shown in Australia and form a sound basis for future assessments of the economic impact of student placements for allied health disciplines.

Raw materials in the manufacture of biotechnology products: regulatory considerations.

Science.gov (United States)

Cordoba-Rodriguez, Ruth

2010-01-01

The Food and Drug Administration's Pharmaceutical cGMPs for the 21st Century initiative emphasizes science and risk-based approaches in the manufacture of drugs. These approaches are reflected in the International Conference on Harmonization (ICH) guidances ICH Q8, Q9, and Q10 and encourage a comprehensive assessment of the manufacture of a biologic, including all aspects of manufacture that have the potential to affect the finished drug product. Appropriate assessment and management of raw materials are an important part of this initiative. Ideally, a raw materials program should strive to assess and minimize the risk to product quality. With this in mind, risk-assessment concepts and control strategies will be discussed and illustrated by examples, with an emphasis on the impact of raw materials on cell substrates. Finally, the life cycle of the raw material will be considered, including its potential to affect the drug product life cycle. In this framework, the supply chain and the vendor-manufacturer relationship will be explored as important parts of an adequate raw materials control strategy.

Production and Resource Scheduling in Mass Customization with Dependent Setup Consideration

DEFF Research Database (Denmark)

Nielsen, Izabela Ewa; Bocewicz, G.; Do, Ngoc Anh Dung

2014-01-01

will contribute to the success of mass customization. This paper addresses the problem of production and resource scheduling for a production system with dependent setup and internal transportation such as AGVs in a mass customization environment. A constraint-programming-based methodology is developed to satisfy...

Impact of scribes on patient interaction, productivity, and revenue in a cardiology clinic: a prospective study

Directory of Open Access Journals (Sweden)

Kenney WO

2013-08-01

Full Text Available Alan J Bank,1 Christopher Obetz,2 Ann Konrardy,2 Akbar Khan,1 Kamalesh M Pillai,1 Benjamin J McKinley,1 Ryan M Gage,1 Mark A Turnbull,1 William O Kenney1 1United Heart and Vascular Clinic, St Paul, MN, USA; 2Abbott Northwestern Hospital, Minneapolis, MN, USA Objective: Scribes have been used in the emergency department to improve physician productivity and patient interaction. There are no controlled, prospective studies of scribe use in the clinic setting. Methods: A prospective controlled study compared standard visits (20 minute follow-up and 40 minute new patient to a scribe system (15 minute follow-up and 30 minute new patient in a cardiology clinic. Physician productivity, patient satisfaction, physician–patient interaction, and revenue were measured. Results: Four physicians saw 129 patients using standard care and 210 patients with scribes during 65 clinic hours each. Patients seen per hour increased (P < 0.001 from 2.2 ± 0.3 to 3.5 ± 0.4 (59% increase and work relative value units (wRVU per hour increased (P < 0.001 from 3.5 ± 1.3 to 5.5 ± 1.3 (57% increase. Patient satisfaction was high at baseline and unchanged with scribes. In a substudy, direct patient contact time was lower (9.1 ± 2.0 versus 12.9 ± 3.4 minutes; P < 0.01 for scribe visits, but time of patient interaction (without computer was greater (6.7 ± 2.1 versus 1.5 ± 1.9 minutes; P < 0.01. Subjective assessment of physician–patient interaction (1–10 was higher (P < 0.01 on scribe visits (9.1 ± 0.9 versus 7.9 ± 1.1. Direct and indirect (downstream revenue per patient seen was $142 and $2,398, with $205,740 additional revenue generated from the 81 additional patients seen with scribes. Conclusion: Using scribes in a cardiology clinic is feasible, produces improvements in physician–patient interaction, and results in large increases in physician productivity and system cardiovascular revenue. Keywords: physician productivity, medical economics, patient

Epigenetic considerations in aquaculture

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Mackenzie R. Gavery

2017-12-01

Full Text Available Epigenetics has attracted considerable attention with respect to its potential value in many areas of agricultural production, particularly under conditions where the environment can be manipulated or natural variation exists. Here we introduce key concepts and definitions of epigenetic mechanisms, including DNA methylation, histone modifications and non-coding RNA, review the current understanding of epigenetics in both fish and shellfish, and propose key areas of aquaculture where epigenetics could be applied. The first key area is environmental manipulation, where the intention is to induce an ‘epigenetic memory’ either within or between generations to produce a desired phenotype. The second key area is epigenetic selection, which, alone or combined with genetic selection, may increase the reliability of producing animals with desired phenotypes. Based on aspects of life history and husbandry practices in aquaculture species, the application of epigenetic knowledge could significantly affect the productivity and sustainability of aquaculture practices. Conversely, clarifying the role of epigenetic mechanisms in aquaculture species may upend traditional assumptions about selection practices. Ultimately, there are still many unanswered questions regarding how epigenetic mechanisms might be leveraged in aquaculture.

Materials Lifecycle and Environmental Consideration at NASA

Science.gov (United States)

Clark-Ingram, Marceia

2010-01-01

The aerospace community faces tremendous challenges with continued availability of existing material supply chains during the lifecycle of a program. Many obsolescence drivers affect the availability of materials: environmental safety ahd health regulations, vendor and supply economics, market sector demands,and natural disasters. Materials selection has become increasingly more critical when designing aerospace hardware. NASA and DoD conducted a workshop with subject matter experts to discuss issues and define solutions for materials selections during the lifecycle phases of a product/system/component. The three primary lifecycle phases were: Conceptualization/Design, Production & Sustainment, and End of life / Reclamation. Materials obsolescence and pollution prevention considerations were explored for the aforementioned lifecycle phases. The recommended solutions from the workshop are being presented.

Joint pricing and production management: a geometric programming approach with consideration of cubic production cost function

Science.gov (United States)

Sadjadi, Seyed Jafar; Hamidi Hesarsorkh, Aghil; Mohammadi, Mehdi; Bonyadi Naeini, Ali

2015-06-01

Coordination and harmony between different departments of a company can be an important factor in achieving competitive advantage if the company corrects alignment between strategies of different departments. This paper presents an integrated decision model based on recent advances of geometric programming technique. The demand of a product considers as a power function of factors such as product's price, marketing expenditures, and consumer service expenditures. Furthermore, production cost considers as a cubic power function of outputs. The model will be solved by recent advances in convex optimization tools. Finally, the solution procedure is illustrated by numerical example.

Considerations on the influence of fission products in whole core accidents

International Nuclear Information System (INIS)

Meyer Heine, A.; Pattoret, A.; Schmitz, F.

1977-01-01

If the hypothetical Whole Core Accidents which are taken into account in reactor safety analysis can change from one country to another, there is nevertheless a general agreement over their description and main phases. Furthermore the important parameters have also been identified by every laboratory. During the development of such core accidents the role of the fission products in essential. It is not the purpose of this paper to give an exhaustive description of the phases which can be influenced by the fission products, we will try however to focus this study on the most important ones. In a second step we will discuss the equation of state of irradiated fuels; here again one principal preoccupation being to quantify the influence of fission products on reactor accidents. It is not our purpose to enter on the fundamental aspects of the equation of state. The studies and the experimental program launched at the CEA will then be described. Special attention will be directed towards the eventual role of fission products in molten fuel-coolant interactions (MFCls) or the events leading to the initiation of whole core accidents. This paper will be limited to oxide fuels. Whether the whole core accident is initiated by a reactivity defect or a coolant coast-down, one has to deal with four great categories of phenomena. Loss of flow: the power is around the nominal value, while the coolant flow has been reduced by a factor of 5 to 10. This induces boiling and clad weakening. Will the plenum pressure lead to a clad rupture? In case of a rupture, what will be the effect on the voiding of the channel? Transient over power: influence of gases from gaseous and volatile fission products on the fuel movements? MFCIs: Influence of the fission products in the mode of contact between fuel and coolant? Influence on the fuel characteristics. Sodium vapour bubble expansion: influence of the fission products on the heat transfer and eventual condensation of the bubble?

Review of Clinical Pharmacology of Aloe vera L. in the Treatment of Psoriasis.

Science.gov (United States)

Miroddi, Marco; Navarra, Michele; Calapai, Fabrizio; Mancari, Ferdinando; Giofrè, Salvatore Vincenzo; Gangemi, Sebastiano; Calapai, Gioacchino

2015-05-01

Aloe vera L., is a plant used worldwide as folk remedy for the treatment of various ailments, including skin disorders. Its gel is present in cosmetics, medicinal products and food supplements. Psoriasis, an immune-mediated chronic inflammatory disease, involving mainly the skin, affects about the 2-3% of general population. Conventional pharmacological treatments for psoriasis can have limited effectiveness and can cause adverse reactions. For this reason often psoriatic patients look for alternative treatments based on natural products containing Aloe vera. We conducted a systematic review of clinical trials assessing effectiveness and safety of aloe for the treatment of psoriasis. Clinical studies published in English were considered; a total of four clinical trials met inclusion criteria. Studies were also evaluated by using the Jadad scale and Consort Statement in Reporting Clinical trials of Herbal Medicine Intervention. Quality and methodological accuracy of considered studies varied considerably, and some crucial information to reproduce clinical results was missing. We conclude that administration of aloe as cutaneous treatment is generally well tolerated, as no serious side effects were reported. Results on the effectiveness of Aloe vera are contradictory; our analysis reveals the presence of methodological gaps preventing to reach final conclusions. Copyright © 2015 John Wiley & Sons, Ltd.

Neck Rhabdoid Tumors: Clinical Features and Consideration of Autologous Stem Cell Transplant.

Science.gov (United States)

Wolfe, Adam D; Capitini, Christian M; Salamat, Shahriar M; DeSantes, Kenneth; Bradley, Kristin A; Kennedy, Tabassum; Dehner, Louis P; Patel, Neha J

2018-01-01

Extrarenal malignant rhabdoid tumors (MRT) have a poor prognosis despite aggressive therapy. Adding high-dose chemotherapy with autologous stem cell rescue (HDC-ASCR) as consolidative therapy for MRT is controversial. We describe 2 patients, age 13 years and 19 months, with unresectable neck MRT. After chemotherapy and radiotherapy, both underwent HDC-ASCR and remain in remission over 4 years later. We reviewed all published cases of neck MRT, and found poorer outcomes and more variable age of presentation and time to progression than MRT at other sites. Neck MRT may represent a higher-risk subset of MRT, and addition of HDC-ASCR merits consideration.

Prescription Omega-3 Fatty Acid Products and Dietary Supplements Are Not Interchangeable.

Science.gov (United States)

Hilleman, Daniel; Smer, Aiman

2016-01-01

To provide an overview of prescription and dietary supplement omega-3 fatty acid (OM3-FA) products and considerations for clinical use. Narrative review. The PubMed database was searched for cardiovascular-related investigations focused on eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA) (limit: English-only articles). Additional regulatory information on prescription and dietary supplements was obtained from United States Food and Drug Administration online sources. Prescription QM3-FA products are supported by robust clinical development and safety monitoring programs, whereas dietary supplements are not required to demonstrate safety or efficacy prior to marketing. There are no over-the-counter OM3-FA products available in the United States. Investigations of OM3-FA dietary supplements show that quantities of EPA and DHA are highly variable within and between brands. Dietary supplements also may contain potentially harmful components, including oxidized OM3-FA, other lipids, cholesterol, and toxins. Prescription OM3-FA products may contain DHA and EPA or EPA alone. All prescription OM3-FA products have demonstrated statistically significant triglyceride reduction as monotherapy or in combination with statins in patients with hypertriglyceridemia. Differential effects between products containing EPA and DHA compared with a high-purity EPA product (icosapent ethyl) have clinical implications: Increases in low-density lipoprotein cholesterol associated with DHA have the potential to confound strategies for managing patients with dyslipidemia. Cardiovascular outcomes studies of prescription CM3-FA products are ongoing. OM3-FA dietary supplements should not be substituted for prescription products, and prescription OM3-FA products that contain DHA are not equivalent to or interchangeable with high-purity EPA (icosapent ethyl) and should not be substituted for it.

Design considerations of fission and corrosion product in primary system of MONJU

International Nuclear Information System (INIS)

Yanagisawa, T.; Akagane, K.; Yamamoto, K.; Kawashima, K.

1976-01-01

General influence of fission and corrosion products in primary system on MONJU plant design is reviewed. Various research and development works are now in progress to decrease the generation rate, to remove the products more effectively and to develop the methods of evaluation the behaviour of radioactive products. The inventory and distribution of fission and corrosion products in the primary circuit of MONJU are given. The radiation levels on the primary components are estimated to be several roentgens per hour. (author)

Telemetric intra-cranial pressure monitoring: clinical and financial considerations.

Science.gov (United States)

Barber, James M; Pringle, Catherine J; Raffalli-Ebezant, Helen; Pathmanaban, Omar; Ramirez, Roberto; Kamaly-Asl, Ian D

2017-06-01

Intracranial pressure (ICP) measurement is an important diagnostic tool in Neurosurgery. Until relatively recently, conventional monitoring has required that subjects be admitted to a hospital bed and the device is only able to be left in-situ for limited periods of time. We have evaluated a Telemetric ICP monitoring system that has been proven, by several other groups worldwide, to permit rapid, repeated and prolonged ICP measurement, in multiple environments. In our unit, 4 patients have been implanted to-date, between the ages of 4 and 16, manifesting a wide range of complex neurosurgical conditions. The sensors have been left in-situ for between 460 and 632 days. There have been no clinical complications and the system has been universally well tolerated. Clinical events, costs and patient experience were all assessed prior to and following implantation. Overall, there was a significant reduction in associated admissions (44.3%), imaging requirements (72.5%) and costs (50.0%). Subjective feedback from both the patients (where possible) and their families was overwhelmingly positive, partly due to (a) the system's ease of use, (b) its ability to reduce the number of admissions/tests required and (c) the facility for rapid measurement of ICP that permitted on-the-spot reassurance of concerns. Additionally, the ability to monitor ICP at home and/or whilst ambulant, has provided measurements that were hitherto inaccessible to our team, facilitating all the potential benefits that analysis of such information would provide. Indeed, we have seen the resultant management in each case has been completely altered by the availability of this data, reaffirming that the importance of being able to obtain it should not be underestimated. The combination of both this and the ability to markedly improve patient experience, along with generating significant cost-savings, lead the authors to suggest that the implantation of this system should be strongly considered in selected

From pathogenic considerations to a simplified decision-making schema in dry eye disease.

Science.gov (United States)

Labetoulle, M; Baudouin, C

2013-06-01

The modern definition of Dry Eye Disease (DED) combines objective findings, subjective symptoms and mechanistic considerations, among which hyperosmolarity and inflammation play a key role. Historically, DED were classified as due to either insufficient production or impaired stability of tears. There is now evidence that such a dichotomous classification does not fit with the reality of clinical practice, since any abnormality of the ocular surface can trigger disequilibrium in all the other components of tear dynamics. This results in a vicious circle with as many ways to enter as there are causes of destabilization of the ocular surface. Eventually, the patient develops a self-sustaining, and finally severe, DED. Based on these data, we propose a simplified decision-making schema with the goal of assisting ophthalmologists in daily practice in choosing the first line treatment for dry eye disease, and then, if necessary, adapting treatment for the long-term. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

GMP production and characterization of leucine zipper-tagged tumor necrosis factor-related apoptosis-inducing ligand (LZ-TRAIL) for phase I clinical trial.

Science.gov (United States)

Jiang, Jing; Liu, Xiaobin; Deng, Leixiu; Zhang, Peipei; Wang, Guangjun; Wang, Shifu; Liu, Honghao; Su, Yunpeng

2014-10-05

Tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) exhibits potent antitumor activity in a wide range of cancers without deleterious side effects on normal tissues. Several TRAIL derivatives have been developed to improve its pharmacokinetics and therapeutic effects through strategies such as adding a leucine zipper to increase the circulation half-life. To obtain clinical grade LZ-TRAIL for phase I clinical trial, a single batch of 30 L bioreactor culture was performed using the Escherichia coli BL21 (DE3) strain expressing the recombinant LZ-TRAIL. A robust LZ-TRAIL production fermentation process was developed, which could be scaled up from 5L to 50 L, and had a titer of approximately 1.4 g/l. A four-step purification strategy was carried out to obtain a final product with over 95% purity and 45% yield. The final material was filter sterilized, aseptically vialed, and stored at 4°C, and comprehensively characterized using multiple assays (vialed product was sterile, purity was 95%, aggregates were production of phase I clinical trial material. These preclinical investigations warrant further clinical development of this product for cancer therapy. Copyright © 2014. Published by Elsevier B.V.

Implementing the clinical nurse leader role using the Virginia Mason Production System.

Science.gov (United States)

Tachibana, Charleen; Nelson-Peterson, Dana L

2007-11-01

More than 90 members of the American Association of Colleges of Nursing and 190 practice sites have partnered to develop the clinical nurse leader (CNL) role. The partnership has created synergy between education and practice and nurtured innovation and diffusion of learning on a national basis. In this ongoing department, the editor, Jolene Tornabeni, MA, RN, FAAN, FACHE, showcases a variety of nurse leaders who discuss their new patient care delivery models in preparation for the CNL role and CNLs who highlight partnerships with their clinical colleagues to improve patient care. In this article, the authors discuss the needs for changes in the nursing care delivery model, the implementation of the role of the CNL using the tools of the Virginia Mason Production System, as well as early outcomes and future opportunities for the expansion of the CNL role.

Clinical and economic considerations of antiobesity treatment: a review of orlistat

Directory of Open Access Journals (Sweden)

Armineh Zohrabian

2010-07-01

Full Text Available Armineh ZohrabianDivision of Adult and Community Health, Centers for Disease Control and Prevention, Atlanta, GA, USAAbstract: The objective of this study was to review the current knowledge about the use of orlistat from clinical and economic perspectives, and to assess this drug’s public health impact. Weight reduction by current antiobesity drugs, compared to placebo, is at most around 5 kg. Orlistat, the most studied antiobesity drug, is associated with the least-severe adverse effects, but compared with other drugs in its class it also delivers the most modest weight loss versus placebo (less than 3 kg. Orlistat appears to have a favorable risk/benefit profile, and cost-effectiveness ratios seem to be within a range that is generally considered acceptable. In the short-term, orlistat is related to reduced diabetes incidence and to slightly improved blood pressure and lipid profiles. Long-term clinical effects have been largely unstudied, however, and this study did not find reports that considered mortality as an endpoint. Given a very low continuation with orlistat treatment in the population and very modest and, apparently, only short-term clinical effects, orlistat is not likely to have a significant impact on the population health. Public health approaches of improving environmental and social factors to foster healthier food choices and increase physical activity remain essential for addressing the obesity epidemic.Keywords: obesity, orlistat, weight loss, cost-effectiveness

Clinical information in drug package inserts in India

Directory of Open Access Journals (Sweden)

Shivkar Y

2009-01-01

Full Text Available Background: It is widely recognized that accurate and reliable product information is essential for the safe and effective use of medications. Pharmaceutical companies are the primary source of most drug information, including package inserts. Package inserts are printed leaflets accompanying marketed drug products and contain information approved by the regulatory agencies. Studies on package inserts in India, in 1996, had shown that crucial information was often missing and they lacked uniformity. Aim: To assess the presentation and completeness of clinically important information provided in the currently available package inserts in India. Materials and Methods: Package inserts accompanying allopathic drug products marketed by pharmaceutical companies in India were collected. These package inserts were analyzed for the content of clinically important information in various sections. Statistical Analysis: The results were expressed as absolute numbers and percentages. Results: Preliminary analyses revealed that most package inserts did contain information under headings, such as, therapeutic indications, contraindications, undesirable effects, etc., listed in the Drugs and Cosmetics Rules 1945. The findings indicated considerable improvement in package inserts since 1996. However, on critical evaluation it was revealed that clinically important information was not well presented and was often incomplete. Information with regard to pediatric and geriatric use was present in only 44% and 13% of the package inserts, respectively. Only five of the inserts had information on the most frequent adverse drug reactions associated with the drug. Also, information on interactions and overdosage was often missing. Conclusion: Although the package inserts appear to have improved over the past decade there is still a definite need to further refine the clinical information contained, to minimize the risks to patients. This could be brought about by self

Defining the breeding goal for a sheep breed including production and functional traits using market data.

Science.gov (United States)

Theodoridis, A; Ragkos, A; Rose, G; Roustemis, D; Arsenos, G

2017-11-16

In this study, the economic values for production and functional traits of dairy sheep are estimated through the application of a profit function model using farm-level technical and economic data. The traits incorporated in the model were milk production, prolificacy, fertility, milking speed, longevity and mastitis occurrence. The economic values for these traits were derived as the approximate partial derivative of the specified profit function. A sensitivity analysis was also conducted in order to examine how potential changes in input and output prices would affect the breeding goal. The estimated economic values of the traits revealed their economic impact on the definition of the breeding goal for the specified production system. Milk production and fertility had the highest economic values (€40.30 and €20.28 per standard genetic deviation (SDa)), while, mastitis only had a low negative value of -0.57 €/SDa. Therefore, breeding for clinical mastitis will have a minor impact on farm profitability because it affects a small proportion of the flock and has low additive variance. The production traits, which include milk production, prolificacy and milking speed, contributed most to the breeding goal (70.0%), but functional traits still had a considerable share (30.0%). The results of this study highlight the importance of the knowledge of economic values of traits in the design of a breeding program. It is also suggested that the production and functional traits under consideration can be categorized as those which can be efficiently treated through genetic improvement (e.g. milk production and fertility) while others would be better dealt with through managerial interventions (e.g. mastitis occurrence). Also, sub-clinical mastitis that affects a higher proportion of flocks could have a higher contribution to breeding goals.

Establishing Quantitative Within-Subject Confidence Limits For Clinical Stereoroentgenographs

Science.gov (United States)

Korn, Edward L.; Baumrind, Sheldon; Chafetz, Neil; Curry, Sean; Moffitt, Francis

1983-07-01

It is now quite clear that under ideal conditions, discrete points can be located on x-ray films with standard deviations of less than 50 i. However, under routine clinical conditions, such considerations as individual variation in anatomy, movement of the subject between exposures, and variations in image quality combine to produce considerable reductions in the confidence which can be placed in quantitative assessments made from stereoroentgenographic films. This paper discusses some considerations involved in designing mathematical models in such a way as to optimize the use of imperfect data in answering specific clinical questions.

Riding the Plane Wave: Considerations for In Vivo Study Designs Employing High Frame Rate Ultrasound

Directory of Open Access Journals (Sweden)

Jason S. Au

2018-02-01

Full Text Available Advancements in diagnostic ultrasound have allowed for a rapid expansion of the quantity and quality of non-invasive information that clinical researchers can acquire from cardiovascular physiology. The recent emergence of high frame rate ultrasound (HiFRUS is the next step in the quantification of complex blood flow behavior, offering angle-independent, high temporal resolution data in normal physiology and clinical cases. While there are various HiFRUS methods that have been tested and validated in simulations and in complex flow phantoms, there is a need to expand the field into more rigorous in vivo testing for clinical relevance. In this tutorial, we briefly outline the major advances in HiFRUS, and discuss practical considerations of participant preparation, experimental design, and human measurement, while also providing an example of how these frameworks can be immediately applied to in vivo research questions. The considerations put forward in this paper aim to set a realistic framework for research labs which use HiFRUS to commence the collection of human data for basic science, as well as for preliminary clinical research questions.

Medical specialty considerations by medical students early in their clinical experience

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Weissman Charles

2012-03-01

Full Text Available Abstract Background Specialty selection by medical students determines the future composition of the physician workforce. Selection of career specialties begins in earnest during the clinical rotations with exposure to the clinical and intellectual environments of various specialties. Career specialty selection is followed by choosing a residency program. This is the period where insight into the decision process might help healthcare leaders ascertain whether, when, and how to intervene and attempt to influence students' decisions. The criteria students consider important in selecting a specialty and a residency program during the early phases of their clinical rotations were examined. Methods Questionnaires distributed to fifth-year medical students at two Israeli medical schools. Results 229 of 275 (83% questionnaires were returned. 80% of the students had considered specialties; 62% considered one specialty, 25% two, the remainder 3-5 specialties. Students took a long-range view; 55% considered working conditions after residency more important than those during residency, another 42% considered both equally important. More than two-thirds wanted an interesting and challenging bedside specialty affording control over lifestyle and providing a reasonable relationship between salary and lifestyle. Men were more interested in well-remunerated procedure-oriented specialties that allowed for private practice. Most students rated as important selecting a challenging and interesting residency program characterized by good relationships between staff members, with positive treatment by the institution, and that provided much teaching. More women wanted short residencies with few on-calls and limited hours. More men rated as important residencies affording much responsibility for making clinical decisions and providing research opportunities. More than 50% of the students considered it important that their residency be in a leading department, and in

CONSIDERATIONS REGARDING THE E.U. ROLE IN THE WORLD GRAPE PRODUCTION

Directory of Open Access Journals (Sweden)

Agatha POPESCU

2013-01-01

Full Text Available The paper aimed to analyze the EU-27 position in the world grape production based on the data collected from FAO Stat data base for the period 2000-2008, using the index and share methods. The EU-27 is the most important vine cultivator and grape producer in the world. With its 3.5 million ha planted with vine, it accounts for 90.21 % of Europe’s area of vineyards and 48.14 % of the world vine area. In 2008, the EU-27 produced 25.1 million tones grapes placing it on the top position and contributing by 41.56 % to the world production. The top European countries: Italy, Spain, France, Germany and Romania achieved 21.8 million tones grapes, representing 86.98 % of the EU-27 and 32.96 % of the world grape production. Italy, Spain and France are among the top 10 grape producers in the world. As a conclusion, even thou the EU-27 planted area decreased by 8.24 % and its grape production declined by 16.16 %, the EU-27 continues to remain the main grape producer in the world.

Magnet-Retained Two-Mini-Implant Overdenture: Clinical and Mechanical Consideration

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Yuichi Ishida

2016-10-01

Full Text Available Two-implant overdentures have become the accepted treatment for restoring mandibular edentulism. The dimensions of regular implants sometimes limit their use, such as in the case of narrow ridges. Mini-implants with reduced diameters (less than 3.0 mm enable insertion into narrow ridges. A magnet-retained two-mini-implant overdenture system was developed and is described in this paper. Additionally, we describe a clinical mandibular procedure using the system and evaluate its biomechanical performance.

Connecting Classroom, Clinic, and Context: Clinical Reasoning Strategies for Clinical Instructors and Academic Faculty.

Science.gov (United States)

Furze, Jennifer; Kenyon, Lisa K; Jensen, Gail M

2015-01-01

Clinical reasoning is an essential skill in pediatric physical therapist (PT) practice. As such, explicit instruction in clinical reasoning should be emphasized in PT education. This article provides academic faculty and clinical instructors with an overview of strategies to develop and expand the clinical reasoning capacity of PT students within the scope of pediatric PT practice. Achieving a balance between deductive reasoning strategies that provide a framework for thinking and inductive reasoning strategies that emphasize patient factors and the context of the clinical situation is an important variable in educational pedagogy. Consideration should be given to implementing various teaching and learning approaches across the curriculum that reflect the developmental level of the student(s). Deductive strategies may be helpful early in the curriculum, whereas inductive strategies are often advantageous after patient interactions; however, exposure to both is necessary to fully develop the learner's clinical reasoning abilities. For more insights from the authors, see Supplemental Digital Content 1, available at http://links.lww.com/PPT/A87.

Biofuel Production: Considerations for USACE Civil Works Business Lines

Science.gov (United States)

2014-12-01

feedstock for biofuel production has led to research whereby several genera of duckweed ( Lemna , Landoltia, Spirodela, Wolffia, Wolfiella) have been...as well as the general public when rendering its final permit decisions. Regulatory responsibilities include evaluating minor activities such as...reservoirs scattered along minor river systems in other parts of the United States (Kasul et al. 1998) Through a series of legislative acts in the

Legal aspects of the production and application of radiopharmaceuticals in Germany

International Nuclear Information System (INIS)

Kuwert, T.; Prante, O.; Meyer, G.

2009-01-01

This article deals with the regulation of the production and use of radiopharmaceuticals in Germany. As in other countries, radiopharmaceuticals may be used when licensed by the German equivalent of the Federal Drug Agency or in clinical trials. Furthermore, non-licensed radiopharmaceuticals can be administered to patients for diagnosis when they are produced in the same institution and not more than 20 doses per week and radiopharmaceutical are given. A prerequisite for these three ways of use is the production of the radiopharmaceutical in question according to the guidelines of the good manufacturing practice (GMP) which creates considerable problems for the usually small PET centers installed in the German university hospitals. German law offers a further possibility to apply non-licensed radiopharmaceuticals for clinical purposes: their administration to patients is not forbidden when performed by a physician who produces the substance himself or is at least responsible for its synthesis. This regulation has, however, been met with criticism by government agencies. (orig.)

Catching moving targets: cancer stem cell hierarchies, therapy-resistance & considerations for clinical intervention.

LENUS (Irish Health Repository)

Gasch, Claudia

2017-01-01

It is widely believed that targeting the tumour-initiating cancer stem cell (CSC) component of malignancy has great therapeutic potential, particularly in therapy-resistant disease. However, despite concerted efforts, CSC-targeting strategies have not been efficiently translated to the clinic. This is partly due to our incomplete understanding of the mechanisms underlying CSC therapy-resistance. In particular, the relationship between therapy-resistance and the organisation of CSCs as Stem-Progenitor-Differentiated cell hierarchies has not been widely studied. In this review we argue that modern clinical strategies should appreciate that the CSC hierarchy is a dynamic target that contains sensitive and resistant components and expresses a collection of therapy-resisting mechanisms. We propose that the CSC hierarchy at primary presentation changes in response to clinical intervention, resulting in a recurrent malignancy that should be targeted differently. As such, addressing the hierarchical organisation of CSCs into our bench-side theory should expedite translation of CSC-targeting to bed-side practice. In conclusion, we discuss strategies through which we can catch these moving clinical targets to specifically compromise therapy-resistant disease.

Problems in clinical practice of domestic supply of 99Mo/99mTc. Considerations on the domestic production of 99Mo/99mTc

International Nuclear Information System (INIS)

Yamabayashi, Hisamichi

2012-01-01

At present, a bulky import product, 99 Mo supplied in Japan is produced by a nuclear fission method which enables to produce a generator system with no need of commercially preparing 99m Tc-labeled radiopharmaceuticals due to its high specific activity. However its usage of enriched uranium target leads to avoiding the fission method from the option of domestic production. In order to secure the domestic supply of 99 Mo/ 99m Tc, the neutron activation method, aiming to meet about 20% of domestic demand, is under development along with the re-start program of JMTR. Development of various production methods using accelerators are also in progress. In those non-fission methods with reactors or accelerators, rapid and effective procedures for concentration and refinement of 99m Tc solution eluted from 99 Mo of low specific activity are the subjects to be considered for attaining the stable labeling performances. (author)

Designing Epigenome Editors: Considerations of Biochemical and Locus Specificities.

Science.gov (United States)

Sen, Dilara; Keung, Albert J

2018-01-01

The advent of locus-specific protein recruitment technologies has enabled a new class of studies in chromatin biology. Epigenome editors enable biochemical modifications of chromatin at almost any specific endogenous locus. Their locus specificity unlocks unique information including the functional roles of distinct modifications at specific genomic loci. Given the growing interest in using these tools for biological and translational studies, there are many specific design considerations depending on the scientific question or clinical need. Here we present and discuss important design considerations and challenges regarding the biochemical and locus specificities of epigenome editors. These include how to account for the complex biochemical diversity of chromatin; control for potential interdependency of epigenome editors and their resultant modifications; avoid sequestration effects; quantify the locus specificity of epigenome editors; and improve locus specificity by considering concentration, affinity, avidity, and sequestration effects.

Glucose & sodium chloride induced biofilm production & ica operon in clinical isolates of staphylococci

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Astha Agarwal

2013-01-01

Full Text Available Background & objectives: All colonizing and invasive staphylococcal isolates may not produce biofilm but may turn biofilm producers in certain situations due to change in environmental factors. This study was done to test the hypothesis that non biofilm producing clinical staphylococci isolates turn biofilm producers in presence of sodium chloride (isotonic and high concentration of glucose, irrespective of presence or absence of ica operon. Methods: Clinical isolates of 100 invasive, 50 colonizing and 50 commensal staphylococci were tested for biofilm production by microtiter plate method in different culture media (trypticase soy broth alone or supplemented with 0.9% NaCl/ 5 or 10% glucose. All isolates were tested for the presence of ica ADBC genes by PCR. Results: Biofilm production significantly increased in the presence of glucose and saline, most, when both glucose and saline were used together. All the ica positive staphylococcal isolates and some ica negative isolates turned biofilm producer in at least one of the tested culture conditions. Those remained biofilm negative in different culture conditions were all ica negative. Interpretation & conclusions: The present results showed that the use of glucose or NaCl or combination of both enhanced biofilm producing capacity of staphylococcal isolates irrespective of presence or absence of ica operon.

Development of Production Systems

DEFF Research Database (Denmark)

Christiansen, Thomas Bøhm

1997-01-01

This paper presents the initial considerations related to a Ph.D. study initiated at IPV, DTU in February 1997, concerning the research subject "Development of Production Systems". The content and aim of this paper is to 1) to introduce the study by......This paper presents the initial considerations related to a Ph.D. study initiated at IPV, DTU in February 1997, concerning the research subject "Development of Production Systems". The content and aim of this paper is to 1) to introduce the study by...

Design considerations for incineration of transuranic-contaminated solid wastes

International Nuclear Information System (INIS)

Koenig, R.A.

1977-01-01

The Los Alamos Scientific Laboratory has established a development program to evaluate alternate production-level (100-200 lb/hr throughput) volume reduction processes for transuranic-contaminated solid waste. The first process selected for installation and study is based on controlled-air incineration. Design considerations leading to selection of feed preparation, incineration, residue removal, and off-gas cleanup components and their respective radioactive containment provisions will be presented

Trichomonas vaginalis origins, molecular pathobiology and clinical considerations.

Science.gov (United States)

Hirt, Robert P; Sherrard, Jackie

2015-02-01

To integrate a selection of the most recent data on Trichomonas vaginalis origins, molecular cell biology and T. vaginalis interactions with the urogenital tract microbiota with trichomoniasis symptoms and clinical management. Transcriptomics and proteomics datasets are accumulating, facilitating the identification and prioritization of key target genes to study T. vaginalis pathobiology. Proteins involved in host sensing and cytoskeletal plasticity during T. vaginalis amoeboid transformation were identified. T. vaginalis was shown to secrete exosomes and a macrophage migration inhibitory factor-like protein that both influence host-parasite interactions. T. vaginalis co-infections with Mycoplasma species and viruses were shown to modulate the inflammatory responses, whereas T. vaginalis interactions with various Lactobacillus species inhibit parasite interactions with human cells. T. vaginalis infections were also shown to be associated with bacterial vaginosis. A broader range of health sequelae is also becoming apparent. Diagnostics for both women and men based on the molecular approaches are being refined, in particular for men. New developments in the molecular and cellular basis of T. vaginalis pathobiology combined with data on the urogenital tract microbiota and immunology have enriched our knowledge on human-microbe interactions that will contribute to increasing our capacity to prevent and treat T. vaginalis and other sexually transmitted infections.

A study of biceps brachii muscle: Anatomical considerations and clinical implications

Directory of Open Access Journals (Sweden)

Vaishaly Kishore Bharambe

2015-01-01

Full Text Available Context: Biceps brachii muscle (BBm is a very variable muscle, the variations being associated with a variety of clinical conditions. This study delves on anatomical variations in this muscle, possible phylogenic causes for their frequency and their clinical importance. Aims: The aim was to study anatomy of bicep brachii muscle, its variations and their clinical importance. Subjects and Methods: A total of 60 upper limbs preserved in 10% formalin were dissected meticulously to study anatomical details of the BBm. Results: The incidence of variation in anatomy of BBm was 15%, with incidence being 11.6% and 3.3% among male and female cadavers studied, respectively. Variation was unilateral in 10% and bilateral in 3.3%. The incidence of third head was 13.3% out of which 3.3% took origin from the capsule of the shoulder joint, 8.3% from humerus, and 1.6% from brachialis muscle. Incidence of extra bellies of insertion was found to be 1.6%. A 3.3% incidence was observed in the nerve supply. Conclusions: Variations in BBm are a reflection of its late development in human phylum. The extra bellies can cause neurovascular compression, change the kinematics at the elbow joint and be misinterpreted as tears of muscle on magnetic resonance imaging. They should be watched for in the shoulder as well as elbow joint surgeries. The authors suggest that the extra bellies of BBm instead of being labeled as third, fourth or fifth heads, can be classified as those of origin and insertion and bellies of origin be referred to clearly as capsular, humeral or brachial heads.

Production of 177Lu for targeted radionuclide therapy: Available options

International Nuclear Information System (INIS)

Dah, Ashutosh; Pillai, Maroor Raghavan Ambikalmajan; Knapp, Furn F. Jr.

2015-01-01

This review provides a comprehensive summary of the production of 177 Lu to meet expected future research and clinical demands. Availability of options represents the cornerstone for sustainable growth for the routine production of adequate activity levels of 177 Lu having the required quality for preparation of a variety of 177 Lu-labeled radiopharmaceuticals. The tremendous prospects associated with production of 177 Lu for use in targeted radionuclide therapy (TRT) dictate that a holistic consideration should evaluate all governing factors that determine its success. While both “direct” and “indirect” reactor production routes offer the possibility for sustainable 177 Lu availability, there are several issues and challenges that must be considered to realize the full potential of these production strategies. This article presents a mini review on the latest developments, current status, key challenges and possibilities for the near future. A broad understanding and discussion of the issues associated with 177 Lu production and processing approaches would not only ensure sustained growth and future expansion for the availability and use of 177 Lu-labeled radiopharmaceuticals, but also help future developments

Medical radioisotopes production at the isochronous cyclotron in Alma-Ata

International Nuclear Information System (INIS)

Arzumanov, A.A.; Batischev, V.N.; Gladun, V.K.; Kochetkov, V.L.

1988-01-01

High efficiency cyclotron operations (up to 5200 hours of beam time a year) considerably increased the possibility to perform both fundamental and applied scientific work. There appeared possibility to accelerate protons in a wide energy range from 6 to 30 MeV and realize correspondingly the nuclear reactions up to (A, 3n). This paper reports that among different applied tasks performed at the cyclotron the special program of cyclotron production of short-lived medical radioisotopes iodine-123, thallium-201, cadmium-109 in the first place and some others to satisfy clinic needs of Alma-Ata and its region has special importance. In accordance with this program the preparation to produce iodine-123 is being held and regular production of Thallium chloride, thallium-201 pharmaceptical is started

Nerve growth factor, clinical applications and production of the recombinant protei

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M. Zangi

2017-01-01

Full Text Available The mammalian neurotrophin family proteins, nerve growth factor (NGF, brain-derived neurotrophic factor (BDNF, neurotrophin-3 (NT-3 and neurotrophin-4/5 (NT-4/5 are known as neuronal survival factors. NGF, one of the most important cytokines, is composed of 118 amino acids. NGF is involved in the growth and differentiation of neural cells of the vertebrate peripheral sympathetic nerve as well as basal forebrain cholinergic neurons which degenerate in Alzheimer’s disease. In addition, it is implicated in the regulation of synaptic transmission and synaptogenesis in the central nervous system. NGF is produced by a variety of immune cells, including B cells, T cells, monocytes and mast cells as well as nervous system and binds through two distinct receptors, TrkA and p75NTR which signaling through them leads to the neuronal differentiation and cell death respectively. Considering the importance of this protein as a drug, NGF has been proposed for the treatment of neuron degenerative diseases such as Alzheimer's, Parkinson's and multiple sclerosis. To produce enough protein for research and clinical applications, genetic engineering techniques are used to produce recombinant forms. To date, there are no reports about the systems for production of the recombinant human NGF in an effective, low cost, with industrial production. Plants as a safe host generally offer major advantages such as free of animal pathogens, low costs, the ability to produce a protein similar to natural protein, and industrial production in large scale. Then they are suitable for the production of recombinant human NGF.

Supplier/customer considerations in corporate financial decisions

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Jayant R. Kale

2014-09-01

Full Text Available Earlier research focussed on firm characteristics and the interests of financial stakeholders (shareholders and bondholders as determinants of corporate policies. Subsequent research recognized that corporate policies are determined in a broader environment that includes nonfinancial stakeholders such as suppliers, customers, labour etc. In this paper, we summarize the theoretical and empirical research that includes supplier/customer considerations in the determination of corporate policies such as capital structure, dividends, takeovers, earnings management, and product quality. We highlight the significant effect that the inclusion of supplier/customer interests has on these corporate policies.

Environmental considerations for alternative fusion reactor blankets

International Nuclear Information System (INIS)

Johnson, A.B. Jr.; Young, J.R.

1975-01-01

Comparisons of alternative fusion reactor blanket/coolant systems suggest that environmental considerations will enter strongly into selection of design and materials. Liquid blankets and coolants tend to maximize transport of radioactive corrosion products. Liquid lithium interacts strongly with tritium, minimizing permeation and escape of gaseous tritium in accidents. However, liquid lithium coolants tend to create large tritium inventories and have a large fire potential compared to flibe and solid blankets. Helium coolants minimize radiation transport, but do not have ability to bind the tritium in case of accidental releases. (auth)

Considerations on pressure build-up in deep geological repositories for radioactive waste

International Nuclear Information System (INIS)

Beer, Hans-Frieder

2015-01-01

Gas formation caused by corrosion of metals is a pivotal point with respect to the safety analysis of deep geological repositories. Solid corrosion products are formed unavoidably during the gas formation. The volumes of these solid corrosion products are multiples of the original waste volume. These solid corrosion products are chemically extremely stable and result in a pressure increase inside the repository. This pressure is considerably higher than that of the overlaying rock. The question that arises is, why this aspect is not considered in the consulted documents.

Patient attributes warranting consideration in clinical practice guidelines, health workforce planning and policy

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Segal Leonie

2011-09-01

Full Text Available Abstract Background In order for clinical practice guidelines (CPGs to meet their broad objective of enhancing the quality of care and supporting improved patient outcomes, they must address the needs of diverse patient populations. We set out to explore the patient attributes that are likely to demand a unique approach to the management of chronic disease, and which are crucial if evidence or services planning is to reflect clinic populations. These were incorporated into a new conceptual framework; using diabetes mellitus as an exemplar. Methods The patient attributes that informed the framework were identified from CPGs, the diabetes literature, an expert academic panel, and two cross-disciplinary panels; and agreed upon using a modified nominal group technique. Results Full consensus was reached on twenty-four attributes. These factors fell into one of three themes: (1 type/stage of disease, (2 morbid events, and (3 factors impacting on capacity to self-care. These three themes were incorporated in a convenient way in the workforce evidence-based (WEB model. Conclusions While biomedical factors are frequently recognised in published clinical practice guidelines, little attention is given to attributes influencing a person's capacity to self-care. Paying explicit attention to predictable threats to effective self-care in clinical practice guidelines, by drawing on the WEB model, may assist in refinements that would address observed disparities in health outcomes across socio-economic groups. The WEB model also provides a framework to inform clinical training, and health services and workforce planning and research; including the assessment of healthcare needs, and the allocation of healthcare resources.

Ruby laser for treatment of tattoos: technical considerations affecting clinical use

Science.gov (United States)

Grove, Robert E.

1990-06-01

Recent clinical research on the use of ruby lasers for the treatment of tattoos and FIlk approval of a commercial system have renewed interest in this device. In this paper the principles of Q-switched ruby laser operation are reviewed, and potential sources of error in the estimation of delivered fluence are discussed.

Sustainability Concept in Decision-Making: Carbon Tax Consideration for Joint Product Mix Decision

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Wen-Hsien Tsai

2016-11-01

Full Text Available Carbon emissions are receiving greater scrutiny in many countries due to international forces to reduce anthropogenic global climate change. Carbon taxation is one of the most common carbon emission regulation policies, and companies must incorporate it into their production and pricing decisions. Activity-based costing (ABC and the theory of constraints (TOC have been applied to solve product mix problems; however, a challenging aspect of the product mix problem involves evaluating joint manufactured products, while reducing carbon emissions and environmental pollution to fulfill social responsibility. The aim of this paper is to apply ABC and TOC to analyze green product mix decision-making for joint products using a mathematical programming model and the joint production data of pharmaceutical industry companies for the processing of active pharmaceutical ingredients (APIs in drugs for medical use. This paper illustrates that the time-driven ABC model leads to optimal joint product mix decisions and performs sensitivity analysis to study how the optimal solution will change with the carbon tax. Our findings provide insight into ‘sustainability decisions’ and are beneficial in terms of environmental management in a competitive pharmaceutical industry.

Optimal Consumer Electronics Product Take-Back Time with Consideration of Consumer Value

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Yi-Tse Fang

2017-03-01

Full Text Available Rapid economic growth in recent years has transformed our lifestyle to massively produce, consume, and dispose of products, especially for consumer electronics. This change has put great threat to our environment and caused natural resource depletion. Moreover, short product life cycles and quick replacements of consumer electronics create enormous electronic wastes (e-wastes. Without proper waste management, immense environmental damage is expected. In this empirical study, we notice that lots of valuable materials that can still be recycled from these used consumer electronics are left unused at home instead of being recycled at the appropriate time, which causes a low collection rate and a decrease in residual value for the used products. Therefore, it is important for the government and the recyclers to handle them efficiently by increasing the used product take-back rate. Our study develops an assessment model for customer value based on the idea of value engineering and the perspective of product life cycle. We also explore the relationship between product value and the total cost of ownership with an evaluation of their time variation, considering different usage modes for various consumer groups and different recycling award schemes (fixed and variable recycling awards. Proper take-back management is likely to create a win-win situation both for consumers and environmental protection. This study regards the notebook computer as an example to determine the optimal time for recycling laptops based on usage patterns and provides consumers a reference for when to replace their used product. The results from our modeling firstly clearly indicate that consumers with higher frequency of usage have shorter take back times and higher maximum consumer value. Secondly, a variable recycling award scheme with higher maximum consumer value is more practical than a fixed recycling award scheme.

The Odontogenic Keratocysts: A Consideration of the Clinical and Radiologic Features

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Lee, Ji Youn; Lee, Jang Yeol; Kim, Kee Deog; Park, Chang Seo [Dept. of Oral and Maxillofacial Radiology, College of Dentistry, Yensei University, Yensei (Korea, Republic of)

2000-09-15

To determine whether the significant relationship exists between radiographic appearance, whether it is unilocular or multilocular, and its corresponding clinical and histologic features by examining the odontogenic keratocyst clinically, radiologically and histologically. This study was conducted on 48 cases of odontogenic keratocyst from the files of Dental Hospital, Yonsei University for the years 1982 through 1995. The mean age of patients was 30.5 years in the unilocular group and 35.5 years in the multilocular group. The male to female ratio was 1:1.06 in the unilocular group and 1:1.75 in the multilocular group. The chief complaint was swelling in both groups (unilocular 35.1%, multilocular 54.5%). In the occurrence site, the border of the lesion, the displacement and external root resorption of the adjacent teeth, there were no statistically significant difference between the unilocular group and multilocular group, but in the border type, there was statistically significant difference (x{sup 2}-test, p<0.05). Two recurred cases were observed among 11 cases of odontogenic keratocyst. One was unilocular case and the other was multilocular case.

The Odontogenic Keratocysts: A Consideration of the Clinical and Radiologic Features

International Nuclear Information System (INIS)

Lee, Ji Youn; Lee, Jang Yeol; Kim, Kee Deog; Park, Chang Seo

2000-01-01

To determine whether the significant relationship exists between radiographic appearance, whether it is unilocular or multilocular, and its corresponding clinical and histologic features by examining the odontogenic keratocyst clinically, radiologically and histologically. This study was conducted on 48 cases of odontogenic keratocyst from the files of Dental Hospital, Yonsei University for the years 1982 through 1995. The mean age of patients was 30.5 years in the unilocular group and 35.5 years in the multilocular group. The male to female ratio was 1:1.06 in the unilocular group and 1:1.75 in the multilocular group. The chief complaint was swelling in both groups (unilocular 35.1%, multilocular 54.5%). In the occurrence site, the border of the lesion, the displacement and external root resorption of the adjacent teeth, there were no statistically significant difference between the unilocular group and multilocular group, but in the border type, there was statistically significant difference (x 2 -test, p<0.05). Two recurred cases were observed among 11 cases of odontogenic keratocyst. One was unilocular case and the other was multilocular case.

How to achieve synergy between volume replacement and filling products for global facial rejuvenation.

Science.gov (United States)

Raspaldo, Hervé; Aziza, Richard; Belhaouari, Lakhdar; Berros, Philippe; Body, Sylvie; Galatoire, Olivier; Le Louarn, Claude; Michaud, Thierry; Niforos, François; Rousseaux, Isabelle; Runge, Marc; Taieb, Maryna

2011-04-01

The objective of this paper is to provide an expert consensus regarding facial rejuvenation using a combination of volume replacement (Juvéderm(®) VOLUMA(®)), filling products (Juvéderm(®) Ultra product line) and botulinum toxin. The Juvéderm product line exploits innovative 3-D technology, producing a range of cohesive, homogenous gels that produce predictable, long-lasting and natural results. The products are easy to use by practitioners and are well-tolerated by patients, and used in combination can provide additional benefits not achieved with one product alone. An assessment of facial anatomy and consideration of the aging process, as well as available treatment options, are also addressed in determining the best combination of products to use. Outcomes from a questionnaire and workshop sessions focusing on specific aspects of use of the Juvéderm product line and botulinum toxin in daily clinical practice are discussed, and recommendations for product use following debate amongst the experts are provided.

Robust Reliability or reliable robustness? - Integrated consideration of robustness and reliability aspects

DEFF Research Database (Denmark)

Kemmler, S.; Eifler, Tobias; Bertsche, B.

2015-01-01

products are and vice versa. For a comprehensive understanding and to use existing synergies between both domains, this paper discusses the basic principles of Reliability- and Robust Design theory. The development of a comprehensive model will enable an integrated consideration of both domains...

Mindfulness Meditation for Fibromyalgia: Mechanistic and Clinical Considerations.

Science.gov (United States)

Adler-Neal, Adrienne L; Zeidan, Fadel

2017-09-01

Fibromyalgia is a disorder characterized by widespread pain and a spectrum of psychological comorbidities, rendering treatment difficult and often a financial burden. Fibromyalgia is a complicated chronic pain condition that requires a multimodal therapeutic approach to optimize treatment efficacy. Thus, it has been postulated that mind-body techniques may prove fruitful in treating fibromyalgia. Mindfulness meditation, a behavioral technique premised on non-reactive sensory awareness, attenuates pain and improves mental health outcomes. However, the impact of mindfulness meditation on fibromyalgia-related outcomes has not been comprehensively characterized. The present review delineates the existing evidence supporting the effectiveness and hypothesized mechanisms of mindfulness meditation in treating fibromyalgia-related outcomes. Mindfulness-based interventions premised on cultivating acceptance, non-attachment, and social engagement may be most effective in decreasing fibromyalgia-related pain and psychological symptoms. Mindfulness-based therapies may alleviate fibromyalgia-related outcomes through multiple neural, psychological, and physiological processes. Mindfulness meditation may provide an effective complementary treatment approach for fibromyalgia patients, especially when combined with other reliable techniques (exercise; cognitive behavioral therapy). However, characterizing the specific analgesic mechanisms supporting mindfulness meditation is a critical step to fostering the clinical validity of this technique. Identification of the specific analgesic mechanisms supporting mindfulness-based pain relief could be utilized to better design behavioral interventions to specifically target fibromyalgia-related outcomes.

Clinical profile, outcomes and improvement in symptoms and productivity in rhinitic patients in Karachi, Pakistan

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Sherwani Ubaid

2009-12-01

Full Text Available Abstract Background Rhinitis can cause a heavy toll on patients because of its bothersome effects on productivity. This retrospective study was conducted to explore the clinical profile, outcomes and improvement in the symptoms and productivity resulting from treatment of allergic rhinitis in Pakistan. Methods We carried out a retrospective file review of all allergic rhinitis patients who presented to the Ear, Nose, Throat Consulting Clinic from January, 2006 to June, 2008 using a structured proforma especially designed for this purpose. Data was entered and analyzed using SPSS v. 16.0. Results The charts of 169 patients were reviewed. The mean age of the patients was 35.2 ± 9.1 years. Sixty percent patients were male. Ninety eight patients (58% reported allergy symptoms to be present at both home and work. One hundred and two patients (60.4% had symptoms severe enough to cause absence from work or academic activities. Up to seventy one percent patients were spending between 1000 - 3000 Pakistani Rupees (1 US$= 83.3 Pakistani rupees on the treatment of allergic rhinitis per year. One hundred and fifty one patients (89.3% reported an improvement in rhinitic symptoms and productivity while 18 patients (10.7% didn't. This improvement was significantly associated with satisfaction with treatment (p Conclusion Allergic rhinitis, a ubiquitous disease, was seen to cause a strain on patients in the form of recurrent treatment-related expenses as well as absenteeism from work or other daily activities. Symptoms and productivity improved significantly after treatment.

Gatekeepers for pragmatic clinical trials.

Science.gov (United States)

Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

2015-10-01

To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

Sleep Health Issues for Children with FASD: Clinical Considerations.

Science.gov (United States)

Jan, James E; Asante, Kwadwo O; Conry, Julianne L; Fast, Diane K; Bax, Martin C O; Ipsiroglu, Osman S; Bredberg, Elizabeth; Loock, Christine A; Wasdell, Michael B

2010-01-01

This article describes the combined clinical experience of a multidisciplinary group of professionals on the sleep disturbances of children with fetal alcohol spectrum disorders (FASD) focusing on sleep hygiene interventions. Such practical and comprehensive information is not available in the literature. Severe, persistent sleep difficulties are frequently associated with this condition but few health professionals are familiar with both FASD and sleep disorders. The sleep promotion techniques used for typical children are less suitable for children with FASD who need individually designed interventions. The types, causes, and adverse effects of sleep disorders, the modification of environment, scheduling and preparation for sleep, and sleep health for their caregivers are discussed. It is our hope that parents and also researchers, who are interested in the sleep disorders of children with FASD, will benefit from this presentation and that this discussion will stimulate much needed evidence-based research.

Sleep Health Issues for Children with FASD: Clinical Considerations

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James E. Jan

2010-01-01

Full Text Available This article describes the combined clinical experience of a multidisciplinary group of professionals on the sleep disturbances of children with fetal alcohol spectrum disorders (FASD focusing on sleep hygiene interventions. Such practical and comprehensive information is not available in the literature. Severe, persistent sleep difficulties are frequently associated with this condition but few health professionals are familiar with both FASD and sleep disorders. The sleep promotion techniques used for typical children are less suitable for children with FASD who need individually designed interventions. The types, causes, and adverse effects of sleep disorders, the modification of environment, scheduling and preparation for sleep, and sleep health for their caregivers are discussed. It is our hope that parents and also researchers, who are interested in the sleep disorders of children with FASD, will benefit from this presentation and that this discussion will stimulate much needed evidence-based research.

Biotechnological production and applications of Cordyceps militaris, a valued traditional Chinese medicine.

Science.gov (United States)

Cui, Jian Dong

2015-01-01

Cordyceps militaris is a potential harborer of biometabolites for herbal drugs. For a long time, C. militaris has gained considerable significance in several clinical and biotechnological applications. Much knowledge has been gathered with regard to the C. militaris's importance in the genetic resources, nutritional and environmental requirements, mating behavior and biochemical pharmacological properties. The complete genome of C. militaris has recently been sequenced. This fungus has been the subject of many reviews, but few have focused on its biotechnological production of bioactive constituents. This mini-review focuses on the recent advances in the biotechnological production of bioactive compositions of C. militaris and the latest advances on novel applications from this laboratory and many others.

One dozen considerations when working with women in substance abuse groups.

Science.gov (United States)

Bright, Charlotte Lyn; Osborne, Victoria A; Greif, Geoffrey L

2011-01-01

Women and men have different histories, presentations, and behaviors in substance abuse groups. Twelve considerations are offered for the beginning group leader when encountering women with substance abuse issues. These include understanding sexism, what brings women to treatment, and how women behave in group treatment. Implications for clinical practice with women in single-gender and mixed-gender groups are included.

Conditions and strategies for integrating ergonomics into product development

DEFF Research Database (Denmark)

Broberg, Ole

1996-01-01

Ergonomics considerations at the stage of product development in industry is a major strategy for prevention of work-related injuries and illnesses among employees at the time of manufacture of new products. This study elucidates some important conditions and possibilities for integrating...... such considerations during the product development process. Special attention is paid to the role of design and production engineers. Based on different understandings of the product development process four approaches to integration of ergonomics are outlined....

Caesarean section in a patient with varicella: Anaesthesia considerations and clinical relevance

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Nandini M Dave

2007-01-01

Full Text Available A primigravida with chicken pox was posted for an emergency caesarean section. General anaesthesia was administered. Key issues in anaesthesia management and the clinical implications are discussed.

Extractables and leachables considerations for prefilled syringes.

Science.gov (United States)

Jenke, Dennis R

2014-10-01

Use of pre-filled syringes as both a packaging and delivery system for pharmaceutical drug products is accelerating. Pre-filled syringes must meet the quality and suitability for use requirements for both systems, including compatibility with the drug product. Relevant incompatibilities between pre-filled syringes and drug products include the safety of syringe-based leachables that accumulate in drug products and the ability of leachables to interact with the drug product's ingredients as such interactions can affect safety, efficacy, stability and physical viability. Relevant suitability considerations for pre-filled syringes are discussed herein and specific examples of suitability for use issues for pre-filled syringes are cited, focusing on extractables associated with pre-filled syringes and leachables derived from such syringes. Aspects considered include the toxicological impact of leachables, their ability to alter the efficacy of drug products and to produce other undesirable outcomes such as aggregation and immunogenic responses. Materials used in pre-filled syringes and the conditions of use minimize the traditional safety risk associated with leachables. However, drug products that use pre-filled syringes are prone to non-traditional interactions such as disruption of protein conformation, leading to potential efficacy, safety and quality issues. In order to qualify pre-filled syringes for use, the traditional approach of measuring extractables and leachables and inferring their effect must be augmented by rigorous compatibility testing. Research into the fundamental relationship between leachables and drug substances will be necessary so the more time- and cost-efficient 'measure and infer' approach can be widely implemented.

THE BIG PICTURE ON SMALL MEDICINE: THE STATE OF NANOMEDICINE PRODUCTS APPROVED FOR USE OR IN CLINICAL TRIALS

Science.gov (United States)

Etheridge, Michael L.; Campbell, Stephen A.; Erdman, Arthur G.; Haynes, Christy L.; Wolf, Susan M.; McCullough, Jeffrey

2015-01-01

Developments in nanomedicine are expected to provide solutions to many of modern medicine’s unsolved problems, so it is no surprise that literature is flush with articles discussing the subject. However, existing reviews tend to focus on specific sectors of nanomedicine or take a very forward looking stance and fail to provide a complete perspective on the current landscape. This article provides a more comprehensive and contemporary inventory of nanomedicine products. A keyword search of literature, clinical trial registries, and the Web, yielded 247 nanomedicine products that are approved or in various stages of clinical study. Specific information on each was gathered, so the overall field could be described based on various dimensions, including: FDA classification, approval status, nanoscale size, treated condition, nanostructure, and others. In addition to documenting the large number of nanomedicine products already in human use, this study indentifies some interesting trends forecasting the future of nanomedicine. PMID:22684017

Influence of Amino Acids in Dairy Products on Glucose Homeostasis: The Clinical Evidence.

Science.gov (United States)

Chartrand, Dominic; Da Silva, Marine S; Julien, Pierre; Rudkowska, Iwona

2017-06-01

Dairy products have been hypothesized to protect against type 2 diabetes because of their high content of whey proteins, rich in branched-chain amino acids (BCAAs) - leucine, isoleucine and valine - and lysine, which may decrease postprandial glucose responses and stimulate insulin secretion. Paradoxically, epidemiologic studies also show that higher levels of plasma BCAAs have been linked to insulin resistance and type 2 diabetes. Therefore, the objective was to review the recent clinical evidence concerning the intake of amino acids found in dairy proteins so as to determine their impact on glucose homeostasis in healthy persons and in those with prediabetes and type 2 diabetes. Clinical studies have reported that the major dairy amino acids, namely, leucine, isoleucine, glutamine, phenylalanine, proline and lysine, have beneficial effects on glucose homeostasis. Yet the reported doses of amino acids investigated are too elevated to be reached through adequate dairy product intake. The minor dairy amino acids, arginine and glycine, may improve glucose homeostasis by improving other risk factors for type 2 diabetes. Further, the combination of amino acids may also improve glucose-related outcomes, suggesting additive or synergistic effects. Nevertheless, additional long-term studies in individuals with prediabetes and type 2 diabetes are needed to ascertain the benefits for glucose homeostasis of amino acids found in dairy foods. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

Design considerations of a real-time clinical confocal microscope

Science.gov (United States)

Masters, Barry R.

1991-06-01

A real-time clinical confocal light microscope provides the ophthalmologist with a new tool for the observation of the cornea and the ocular lens. In addition, the ciliary body, the iris, and the sclera can be observed. The real-time light microscopic images have high contrast and resolution. The transverse resolution is about one half micron and the range resolution is one micron. The following observations were made with visible light: corneal epithelial cells, wing cells, basal cells, Bowman's membrane, nerve fibers, basal lamina, fibroblast nuclei, Descemet's membrane, endothelial cells. Observation of the in situ ocular lens showed lens capsule, lens epithelium, lens fibrils, the interior of lens fibrils. The applications of the confocal microscope include: eye banking, laser refractive surgery, observation of wound healing, observation of the iris, the sciera, the ciliary body, the ocular lens, and the intraocular lens. Digital image processing can produce three-dimensional reconstructions of the cornea and the ocular lens.

Considerations on Cattle Stock and Cow Fresh Milk Production in the EU Countries

Directory of Open Access Journals (Sweden)

Agatha Popescu

2011-10-01

Full Text Available The paper aimed to analyze the evolution of cattle stock and cow milk production in order to point out the main trends and differences between the EU-27 member states in the period 2004-2008. The data collected from FAO Stat, 2010 have been processed calculating the fixed basis index, average annual rhythm index and also the share of each EU state in cow milk production at the EU and world level.The main trends in the EU concerning cow milk sector are the continuous decrease in cattle stock, the increase of cow milk yield under the conditions of keeping a constant milk production and also milk production per capita. In 2008, the EU-27 was raising 90,478 thou cattle, and produced 149,388 thou tons cow fresh milk. The EU -27 is placed on the 5th position for number of cattle and on the 1st position for cow milk production, producing 25.8 % of world production. The largest milk producers in the EU-27 are Germany, France, United Kingdom, Poland, Netherlands, Italy, Spain, Ireland, Romania and Denmark, whose contribution to the EU productions is 82.82 %.

Working in London hospitals: perceptions of place in nursing students' employment considerations.

Science.gov (United States)

Brodie, David A; Andrews, Gavin J; Andrews, Justin P; Thomas, B Gail; Wong, Josephine; Rixon, Lorna

2005-11-01

During the past decade, a distinct body of research has started to investigate the dynamics between nursing and place. However, despite attention being paid to a wide-range of nursing subjects, few studies have engaged with the important topic of labour force recruitment. In this context, this study uses a combined questionnaire (n=650), interview (n=30) and focus group (n=7) survey of London-based students, and investigates the complex mix of experiences and perceptions that result in hospitals having varying degrees of popularity as potential workplaces. The findings suggest experiences and perceptions of institutions-often gained on clinical placements-to be important, particularly relating to feeling valued, the quality of patient care, clinical and educational opportunities and team cohesion. These are often combined with experiences and perceptions of locality, relating to factors such as cost of living, travel considerations and sense of personnel safety. The study demonstrates that place is relevant to employment decision-making on multiple scales from wards to regions. Furthermore, that perceptions of potential workplaces result from engagements with complex mixes of cultural, economic and physical features, many of which are the consequences of management. It is argued that in order to effectively unpack workplaces, geographical research of nursing labour may benefit from researching simultaneously both 'inside' institutions, focusing on their dominant cultures of production and sub-cultures, and 'outside', focusing on their local urban or rural contexts.

IMPACT OF NEW PRODUCTS WITH A FLOUR DIETARY SUPPLEMENTS "RAPAMID" ON CLINICAL STATE OF THE HUMAN

Directory of Open Access Journals (Sweden)

E. I. Kireevа

2015-01-01

Full Text Available Summary. Тhe principal problems, which the food industry of Ukraine is confronted with, is to provide the population with foodstuffs of high biological value. At the moment the technology of producing traditional foodstuffs is being improved and new generation of foodstuffs, which meet today’s requirements, is being made. These are foodstuffs with balanced composition, low calorie, sugar and fat content, high content of healthy ingredients for functional and therapeutic purposes. Taking into account that bread is one of the principal foodstuffs, the task of reducing caloric content of baked goods and enriching them with dietary fibers, vitamins and mineral substances is important and urgent. One of the main tasks of the food industry in Ukraine today is the search for new types of additives that contain a complex of functional ingredients and can give therapeutic and prophylactic properties for food products. The article presents the results of a clinical study of dietary additive "Rapamid" and flour products using this additive for the human body. The authors studied radioprotective properties of dietary additive "Rapamid" and flour products with it. Also it was investigated the influence of these additives and products with it on the general clinical condition of the children who receive high doses of radiation. The obtained results show that additional appointment to the normal diet and the basic treatment of dietary аdditive "Rapamid" and flour products with the use of this additive promotes children's immunity, disease prevention with stress and physical stress. Dietary additive "Rapamid" and flour products using this have antioxidant, anti-allergic and radioprotective properties, have positively influences on the cardio - vascular and hematopoietic systems, displays the body of toxic elements and radionuclides.

The early career researcher's toolkit: translating tissue engineering, regenerative medicine and cell therapy products.

Science.gov (United States)

Rafiq, Qasim A; Ortega, Ilida; Jenkins, Stuart I; Wilson, Samantha L; Patel, Asha K; Barnes, Amanda L; Adams, Christopher F; Delcassian, Derfogail; Smith, David

2015-11-01

Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in tissue engineering and regenerative medicine translation, we discuss common pitfalls associated with translational research, providing practical solutions and important considerations which will aid process and product development. Suggestions range from effective project management, consideration of key manufacturing, clinical and regulatory matters and means of exploiting research for successful commercialization.

75 FR 57472 - Clinical Investigator Training Course

Science.gov (United States)

2010-09-21

... days in advance. SUPPLEMENTARY INFORMATION: Clinical trial investigators play a critical role in the... toxicological, pharmacological, and manufacturing data to support investigational use in humans; Fundamental issues in the design and conduct of clinical trials; Statistical and analytic considerations in the...

DOE handbook: Design considerations

International Nuclear Information System (INIS)

1999-04-01

The Design Considerations Handbook includes information and suggestions for the design of systems typical to nuclear facilities, information specific to various types of special facilities, and information useful to various design disciplines. The handbook is presented in two parts. Part 1, which addresses design considerations, includes two sections. The first addresses the design of systems typically used in nuclear facilities to control radiation or radioactive materials. Specifically, this part addresses the design of confinement systems and radiation protection and effluent monitoring systems. The second section of Part 1 addresses the design of special facilities (i.e., specific types of nonreactor nuclear facilities). The specific design considerations provided in this section were developed from review of DOE 6430.1A and are supplemented with specific suggestions and considerations from designers with experience designing and operating such facilities. Part 2 of the Design Considerations Handbook describes good practices and design principles that should be considered in specific design disciplines, such as mechanical systems and electrical systems. These good practices are based on specific experiences in the design of nuclear facilities by design engineers with related experience. This part of the Design Considerations Handbook contains five sections, each of which applies to a particular engineering discipline

DOE handbook: Design considerations

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-04-01

The Design Considerations Handbook includes information and suggestions for the design of systems typical to nuclear facilities, information specific to various types of special facilities, and information useful to various design disciplines. The handbook is presented in two parts. Part 1, which addresses design considerations, includes two sections. The first addresses the design of systems typically used in nuclear facilities to control radiation or radioactive materials. Specifically, this part addresses the design of confinement systems and radiation protection and effluent monitoring systems. The second section of Part 1 addresses the design of special facilities (i.e., specific types of nonreactor nuclear facilities). The specific design considerations provided in this section were developed from review of DOE 6430.1A and are supplemented with specific suggestions and considerations from designers with experience designing and operating such facilities. Part 2 of the Design Considerations Handbook describes good practices and design principles that should be considered in specific design disciplines, such as mechanical systems and electrical systems. These good practices are based on specific experiences in the design of nuclear facilities by design engineers with related experience. This part of the Design Considerations Handbook contains five sections, each of which applies to a particular engineering discipline.

A multidisciplinary audit of clinical coding accuracy in otolaryngology: financial, managerial and clinical governance considerations under payment-by-results.

Science.gov (United States)

Nouraei, S A R; O'Hanlon, S; Butler, C R; Hadovsky, A; Donald, E; Benjamin, E; Sandhu, G S

2009-02-01

To audit the accuracy of otolaryngology clinical coding and identify ways of improving it. Prospective multidisciplinary audit, using the 'national standard clinical coding audit' methodology supplemented by 'double-reading and arbitration'. Teaching-hospital otolaryngology and clinical coding departments. Otolaryngology inpatient and day-surgery cases. Concordance between initial coding performed by a coder (first cycle) and final coding by a clinician-coder multidisciplinary team (MDT; second cycle) for primary and secondary diagnoses and procedures, and Health Resource Groupings (HRG) assignment. 1250 randomly-selected cases were studied. Coding errors occurred in 24.1% of cases (301/1250). The clinician-coder MDT reassigned 48 primary diagnoses and 186 primary procedures and identified a further 209 initially-missed secondary diagnoses and procedures. In 203 cases, patient's initial HRG changed. Incorrect coding caused an average revenue loss of 174.90 pounds per patient (14.7%) of which 60% of the total income variance was due to miscoding of a eight highly-complex head and neck cancer cases. The 'HRG drift' created the appearance of disproportionate resource utilisation when treating 'simple' cases. At our institution the total cost of maintaining a clinician-coder MDT was 4.8 times lower than the income regained through the double-reading process. This large audit of otolaryngology practice identifies a large degree of error in coding on discharge. This leads to significant loss of departmental revenue, and given that the same data is used for benchmarking and for making decisions about resource allocation, it distorts the picture of clinical practice. These can be rectified through implementing a cost-effective clinician-coder double-reading multidisciplinary team as part of a data-assurance clinical governance framework which we recommend should be established in hospitals.

How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study

NARCIS (Netherlands)

Berger, M; Kooyman, P.J.; Makkee, M.; van der Zee, J.S.; Sterk, P. J.; van Dijk, J.; Kemper, E. M.

2016-01-01

Background: Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper

Formulation and quality control of a topical gel product for treatment of melasmaFormulation and quality control of a topical gel product for treatment of melasma

Directory of Open Access Journals (Sweden)

A. Ketabi

2017-11-01

Full Text Available Background and objectives: Melasma is one of the most common pigmentary disorders. It has a considerable impact on quality of life. The treatment of melasma has still remained a challenge because the efficient treatment has not been proven until now and there is still a need to find new depigmenting products.Allium cepa L. and Cucumis melo L. seeds as well as tragacanth have been introduced in Iranian traditional medicine (ITM as depigmenting agents. Moreover, modern studies have shown their antioxidant and inhibitory mushroom tyrosinase effect.In this study, a topical gel containing Allium cepa L. and Cucumis melo L. seeds extract was prepared with tragacanth and quality control evaluations have been accomplished. Method: After performing quality control of plants seeds and tragacanth according to pharmacopoeia, the ethanol extract of A. cepa and hydroalcoholic extract of C. melo seeds were prepared. An appropriate gel formulation was selected on the base of suitable viscosity. The gel product was formulated using 5% of each plant extracts in tragacanth gel base. In addition, the herbal gel was evaluated using pharmaceutical behavior such as physical appearance, pH, viscosity, spreadability as well as phenolics content. Results: The herbal gel product showed acceptable pharmaceutical behavior as well as considerable phenolic content (1.43±0.01 mg/g. Conclusion: The prepared topical gel product could be a good natural formulation candidate for clinical studies in the field of hyperpigmentation. Moreover, phenolic content of the product could be considered as an indicator for its quality control.

Will dapivirine redeem the promises of anti-HIV microbicides? Overview of product design and clinical testing.

Science.gov (United States)

das Neves, José; Martins, João Pedro; Sarmento, Bruno

2016-08-01

Microbicides are being developed in order to prevent sexual transmission of HIV. Dapivirine, a non-nucleoside reverse transcriptase inhibitor, is one of the leading drug candidates in the field, currently being tested in various dosage forms, namely vaginal rings, gels, and films. In particular, a ring allowing sustained drug release for 1month is in an advanced stage of clinical testing. Two parallel phase III clinical trials are underway in sub-Saharan Africa and results are expected to be released in early 2016. This article overviews the development of dapivirine and its multiple products as potential microbicides, with particular emphasis being placed on clinical evaluation. Also, critical aspects regarding regulatory approval, manufacturing, distribution, and access are discussed. Copyright © 2015 Elsevier B.V. All rights reserved.

Materials considerations in accelerator targets

International Nuclear Information System (INIS)

Peacock, H.B. Jr.; Iyer, N.C.; Louthan, M.R. Jr.

1994-01-01

Future nuclear materials production and/or the burn-up of long lived radioisotopes may be accomplished through the capture of spallation produced neutrons in accelerators. Aluminum clad-lead and/or lead alloys has been proposed as a spallation target. Aluminum was the cladding choice because of the low neutron absorption cross section, fast radioactivity decay, high thermal conductivity, and excellent fabricability. Metallic lead and lead oxide powders were considered for the target core with the fabrication options being casting or powder metallurgy (PM). Scoping tests to evaluate gravity casting, squeeze casting, and casting and swaging processes showed that, based on fabricability and heat transfer considerations, squeeze casting was the preferred option for manufacture of targets with initial core cladding contact. Thousands of aluminum clad aluminum-lithium alloy core targets and control rods for tritium production have been fabricated by coextrusion processes and successfully irradiated in the SRS reactors. Tritium retention in, and release from the coextruded product was modeled from experimental and operational data. Newly produced tritium atoms were trapped by lithium atoms to form a lithium tritide. The effective tritium pressure required for trap or tritide stability was the equilibrium decomposition pressure of tritium over a lithium tritide-aluminum mixture. The temperature dependence of tritium release was determined by the permeability of the cladding to tritium and the local equilibrium at the trap sites. The model can be used to calculate tritium release from aluminum clad, aluminum-lithium alloy targets during postulated accelerator operational and accident conditions. This paper describes the manufacturing technologies evaluated and presents the model for tritium retention in aluminum clad, aluminum-lithium alloy tritium production targets

A roadmap for cost-of-goods planning to guide economic production of cell therapy products.

Science.gov (United States)

Lipsitz, Yonatan Y; Milligan, William D; Fitzpatrick, Ian; Stalmeijer, Evelien; Farid, Suzanne S; Tan, Kah Yong; Smith, David; Perry, Robert; Carmen, Jessica; Chen, Allen; Mooney, Charles; Fink, John

2017-12-01

Cell therapy products are frequently developed and produced without incorporating cost considerations into process development, contributing to prohibitively costly products. Herein we contextualize individual process development decisions within a broad framework for cost-efficient therapeutic manufacturing. This roadmap guides the analysis of cost of goods (COG) arising from tissue procurement, material acquisition, facility operation, production, and storage. We present the specific COG considerations related to each of these elements as identified through a 2013 International Society for Cellular Therapy COG survey, highlighting the differences between autologous and allogeneic products. Planning and accounting for COG at each step in the production process could reduce costs, allowing for more affordable market pricing to improve the long-term viability of the cell therapy product and facilitate broader patient access to novel and transformative cell therapies. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Clinical Research

DEFF Research Database (Denmark)

Christensen, Irene

2016-01-01

This paper is about the logic of problem solving and the production of scientific knowledge through the utilisation of clinical research perspective. Ramp-up effectiveness, productivity, efficiency and organizational excellence are topics that continue to engage research and will continue doing so...... for years to come. This paper seeks to provide insights into ramp-up management studies through providing an agenda for conducting collaborative clinical research and extend this area by proposing how clinical research could be designed and executed in the Ramp- up management setting....

Alaska birch for edge-glued panel production—considerations for wood products manufacturers

Science.gov (United States)

David. Nicholls

2010-01-01

Edge-glued panels could become a natural extension for the birch (Betula papyrifera Marsh.) lumber industry in Alaska, resulting in greater utilization of the birch resource while allowing producers to explore a wider variety of products and markets. Key advantages of edge-glued panel production include the relatively low cost of equipment, the...

Design considerations for high-current superconducting ion linacs

International Nuclear Information System (INIS)

Delayen, J.R.; Bohn, C.L.; Micklich, B.J.; Roche, C.T.; Sagalovsky, L.

1993-01-01

Superconducting linacs may be a viable option for high-current applications such as fusion materials irradiation testing, spallation neutron source, transmutation of radioactive waste, tritium production, and energy production. These linacs must run reliably for many years and allow easy routine maintenance. Superconducting cavities operate efficiently with high cw gradients, properties which help to reduce operating and capital costs, respectively. However, cost-effectiveness is not the sole consideration in these applications. For example, beam impingement must be essentially eliminated to prevent unsafe radioactivation of the accelerating structures, and thus large apertures are needed through which to pass the beam. Because of their high efficiency, superconducting cavities can be designed with very large bore apertures, thereby reducing the effect of beam impingement. Key aspects of high-current cw superconducting linac designs are explored in this context

Value stream mapping as a tool for lean production waste-free production; Wertstromanalyse als Werkzeug fuer Lean Production. Die verschwendungsfreiere Produktion

Energy Technology Data Exchange (ETDEWEB)

Boerkircher, Mikko [Rheinkalk GmbH, Flandersbach (Germany). Bereich Brennen und Veredeln

2010-01-15

In the value stream mapping method the product flow is the focal point of all considerations. The method can be used easily and quickly and produces concrete results. A company soon learns to view its own production in a different light. In the following contribution it is shown how companies can identify potential for improvement in their production. (orig.)

Designer-made meat and dairy products: Consumer-led product development

DEFF Research Database (Denmark)

Grunert, Klaus G.; Valli, Carlotta

2001-01-01

targeting these segments were derived and tested with consumers from these segments. Results show considerable potential for the development of food products which are differentiated in a consumer-based way. The paper closes with a step-model for consumer-led product development adapted to the current state...... of branding and differentiation in the product category.......Consumers differ in the kind of qualities they expect from food products, and they also differ in the way they infer quality from the product information available. Nevertheless, much product innovation in the food sector is still not geared towards specific consumer segments. This is especially...

Designer made meat and dairy products: Consumer-led product development

DEFF Research Database (Denmark)

Grunert, Klaus G.; Valli, Carlotta

targeting these segments were derived and tested with consumers from these segments. Results show considerable potential for the development of food products which are differentiated in a consumer-based way. The paper closes with a step-model for consumer-led product development adapted to the current state...... of branding and differentiation in the product category.......Consumers differ in the kind of qualities they expect from food products, and they also differ in the way they infer quality from the product information available. Nevertheless, much product innovation in the food sector is still not geared towards specific consumer segments. This is especially...

How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study

NARCIS (Netherlands)

Berger, M.; Kooyman, P. J.; Makkee, M.; van der Zee, J. S.; Sterk, P. J.; van Dijk, J.; Kemper, E. M.

2016-01-01

Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the

Considerations for acceptability in Bible translation

Directory of Open Access Journals (Sweden)

Diphus C. Chemorion

2009-09-01

Full Text Available The ministry of Bible translation is an important component of the Great Commission (Matthew 28:18�20 and its mandate is to reach everyone with the word of God. One of the main goals of a Bible translation project is to produce a translation that will be used by the church in a given language group. Bible translation teams believe that the lives of the intended recipients will be changed positively when they gain access to Scripture in their own language. However, recent developments regarding Scripture use have shown that the success of any Bible translation project depends on whether or not its products are acceptable. If a translation is not acceptable to the intended audience, it may not be used, and as a result, it may fail to bring about the desired impact. This article explores the concept of �acceptability� as used in Bible translation and highlights important considerations that translators need to keep in mind in order to enhance the acceptability of their translation products.

Risk mitigation strategies for viral contamination of biotechnology products: consideration of best practices.

Science.gov (United States)

Rosenberg, Amy S; Cherney, Barry; Brorson, Kurt; Clouse, Kathleen; Kozlowski, Steven; Hughes, Patricia; Friedman, Rick

2011-01-01

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) Viral contamination of biotech product facilities is a potentially devastating manufacturing risk and, unfortunately, is more common than is generally reported or previously appreciated. Although viral contaminants of biotech products are thought to originate principally from biological raw materials, all potential process risks merit evaluation. Limitations to existing methods for virus detection are becoming evident as emerging viruses have contaminated facilities and disrupted supplies of critical products. New technologies, such as broad-based polymerase chain reaction screens for multiple virus types, are increasingly becoming available to detect adventitious viral contamination and thus, mitigate risks to biotech products and processes. Further, the industry embrace of quality risk management that promotes improvements in testing stratagems, enhanced viral inactivation methods for raw materials, implementation and standardization of robust viral clearance procedures, and efforts to learn from both epidemiologic screening of raw material sources and from the experience of other manufacturers with regard to this problem will serve to enhance the safety of biotech products available to patients. Based on this evolving landscape, we propose a set of principles for manufacturers of biotech products: Pillars of Risk Mitigation for Viral Contamination of Biotech Products.

Self-regulation method: psychological, physiological and clinical considerations. An overview.

Science.gov (United States)

Ikemi, A; Tomita, S; Kuroda, M; Hayashida, Y; Ikemi, Y

1986-01-01

Body-oriented therapies as relaxation training and certain forms of meditation are gaining popularity in the treatment and prevention of psychosomatic disorders. In this paper, a new method of self-control called self-regulation method (SRM), derived from autogenic training and Zen meditation, is presented. The technique of SRM is introduced. Secondly, physiological studies on SRM using skin temperature, galvanic skin response, and cortical evoked potentials are presented. Thirdly, the results of psychological tests conducted on SRM are presented. These psycho-physiological studies suggest that SRM may elicit a state of 'relaxed alertness'. Fourthly, clinical applications of SRM are discussed, and 3 cases are presented. Finally, SRM is discussed in relation to the psychology and physiology of 'relaxed alertness'.

Theoretical and practical considerations for teaching diagnostic electronic-nose technologies to clinical laboratory technicians

Science.gov (United States)

Alphus D. Wilson

2012-01-01

The rapid development of new electronic technologies and instruments, utilized to perform many current clinical operations in the biomedical field, is changing the way medical health care is delivered to patients. The majority of test results from laboratory analyses, performed with these analytical instruments often prior to clinical examinations, are frequently used...

Effects of copper on CHO cells: cellular requirements and product quality considerations.

Science.gov (United States)

Yuk, Inn H; Russell, Stephen; Tang, Yun; Hsu, Wei-Ting; Mauger, Jacob B; Aulakh, Rigzen P S; Luo, Jun; Gawlitzek, Martin; Joly, John C

2015-01-01

Recent reports highlight the impact of copper on lactate metabolism: CHO cell cultures with higher initial copper levels shift to net lactate consumption and yield lower final lactate and higher titers. These studies investigated the effects of copper on metabolite and transcript profiles, but did not measure in detail the dependences of cell culture performance and product quality on copper concentrations. To more thoroughly map these dependences, we explored the effects of various copper treatments on four recombinant CHO cell lines. In the first cell line, when extracellular copper remained above the limit of detection (LOD), cultures shifted to net lactate consumption and yielded comparable performances irrespective of the differences in copper levels; when extracellular copper dropped below LOD (∼13 nM), cultures failed to shift to net lactate consumption, and yielded significantly lower product titers. Across the four cell lines, the ability to grow and consume lactate seemed to depend on the presence of a minimum level of copper, beyond which there were no further gains in culture performance. Although this minimum cellular copper requirement could not be directly quantified, we estimated its probable range for the first cell line by applying several assumptions. Even when different copper concentrations did not affect cell culture performance, they affected product quality profiles: higher initial copper concentrations increased the basic variants in the recombinant IgG1 products. Therefore, in optimizing chemically defined media, it is important to select a copper concentration that is adequate and achieves desired product quality attributes. © 2014 American Institute of Chemical Engineers.

Clinical Value of High Mobility Group Box 1 and the Receptor for Advanced Glycation End-products in Head and Neck Cancer: A Systematic Review

Directory of Open Access Journals (Sweden)

Nguyen, Austin

2016-04-01

Full Text Available Introduction High mobility group box 1 is a versatile protein involved in gene transcription, extracellular signaling, and response to inflammation. Extracellularly, high mobility group box 1 binds to several receptors, notably the receptor for advanced glycation end-products. Expression of high mobility group box 1 and the receptor for advanced glycation end-products has been described in many cancers. Objectives To systematically review the available literature using PubMed and Web of Science to evaluate the clinical value of high mobility group box 1 and the receptor for advanced glycation end-products in head and neck squamous cell carcinomas. Data synthesis A total of eleven studies were included in this review. High mobility group box 1 overexpression is associated with poor prognosis and many clinical and pathological characteristics of head and neck squamous cell carcinomas patients. Additionally, the receptor for advanced glycation end-products demonstrates potential value as a clinical indicator of tumor angiogenesis and advanced staging. In diagnosis, high mobility group box 1 demonstrates low sensitivity. Conclusion High mobility group box 1 and the receptor for advanced glycation end-products are associated with clinical and pathological characteristics of head and neck squamous cell carcinomas. Further investigation of the prognostic and diagnostic value of these molecules is warranted.

Points for Consideration for dengue vaccine introduction - recommendations by the Dengue Vaccine Initiative.

Science.gov (United States)

Lim, Jacqueline Kyungah; Lee, Yong-Seok; Wilder-Smith, Annelies; Thiry, Georges; Mahoney, Richard; Yoon, In-Kyu

2016-01-01

Dengue is a public health problem in the tropics and subtropics. There are several vaccine candidates in clinical development. However, there may be gaps in the new vaccine introduction after vaccine licensure before it becomes available in developing countries. In anticipation of the first dengue vaccine candidate to be licensed, Dengue Vaccine Initiative (DVI) and, its predecessor, Pediatric Dengue Vaccine Initiative (PDVI) have been working on points for consideration to accelerate evidence-based dengue vaccine introduction, once a vaccine becomes available. In this paper, we review the history of PDVI and its successor, the DVI, and elaborate on the points of consideration for dengue vaccine introduction.

Proliferation resistance considerations for remote small modular reactors

Energy Technology Data Exchange (ETDEWEB)

Whitlock, J., E-mail: whitlockj@aecl.ca [Atomic Energy of Canada Limited, Chalk River, Ontario (Canada); Sprinkle, J., E-mail: j.sprinkle@iaea.org [International Atomic Energy Agency, Vienna (Austria)

2013-07-01

Remotely located Small Modular Reactors at the low end of energy production (on the order of 10 MWe, referenced here as Very Small Modular Reactors or VSMRs) present unique proliferation resistance advantages and challenges. Addressing these challenges in the most efficient manner may not only be desirable, but necessary, for development of this technology. Incorporation of safeguards considerations early in the design process (Safeguards by Design) along with safety, security, economics and other key drivers, is of importance. Operational Transparency may become an essential aspect of the safeguards approach for such systems. (author)

"In the same boat": considerations on the partnership between healthcare providers and manufacturers of health IT products and medical devices.

Science.gov (United States)

Bergh, B

2009-01-01

To assess the current culture of cooperation between healthcare providers (HCPs) and the healthcare industry (HCI) in the domain of Health-IT and Engineering (HITE) and identify possible strategies for improvement. Based on reports in the literature and personal experience, major challenges were identified, the current ways of cooperation defined and their relation to each other analyzed. Four main challenges were identified for both sides involving: products and functionality, integration of IT-Systems with each other and with medical devices, usability, visions and strategic management. None of the four defined cooperation categories cover all aspects of the challenges, but cooperation in small, dedicated groups appeared to provide the most advantages. An increased participation of HCPs in standardization activities is crucial either directly or indirectly via professional or scientific organizations. Cooperation between provider management (hospitals, clinics or systems) and manufacturers of health IT products will be the key factor for success of the HCI while providing substantial benefits for providers. Both sides should invest heavily in such efforts.

Implementing electronic health care predictive analytics: considerations and challenges.

Science.gov (United States)

Amarasingham, Ruben; Patzer, Rachel E; Huesch, Marco; Nguyen, Nam Q; Xie, Bin

2014-07-01

The use of predictive modeling for real-time clinical decision making is increasingly recognized as a way to achieve the Triple Aim of improving outcomes, enhancing patients' experiences, and reducing health care costs. The development and validation of predictive models for clinical practice is only the initial step in the journey toward mainstream implementation of real-time point-of-care predictions. Integrating electronic health care predictive analytics (e-HPA) into the clinical work flow, testing e-HPA in a patient population, and subsequently disseminating e-HPA across US health care systems on a broad scale require thoughtful planning. Input is needed from policy makers, health care executives, researchers, and practitioners as the field evolves. This article describes some of the considerations and challenges of implementing e-HPA, including the need to ensure patients' privacy, establish a health system monitoring team to oversee implementation, incorporate predictive analytics into medical education, and make sure that electronic systems do not replace or crowd out decision making by physicians and patients. Project HOPE—The People-to-People Health Foundation, Inc.

Alcohol in Moderation, Cardioprotection and Neuroprotection: Epidemiological Considerations and Mechanistic Studies

OpenAIRE

Collins, Michael A.; Neafsey, Edward J.; Mukamal, Kenneth J.; Gray, Mary O.; Parks, Dale A.; Das, Dipak K.; Korthuis, Ronald J.

2008-01-01

In contrast to many years of important research and clinical attention to the pathological effects of alcohol (ethanol) abuse, the past several decades have seen the publication of a number of peer-reviewed studies indicating beneficial effects of light-moderate, non-binge consumption of varied alcoholic beverages, as well as experimental demonstrations that moderate alcohol exposure can initiate typically cytoprotective mechanisms. A considerable body of epidemiology associates moderate alco...

IDENTIFYING PRODUCT AND PRICE STRATEGIES FOR DESIGNING TRANSACTIONAL BANKING PACKAGES ADDRESSED TO SMES (CONSIDERATIONS

Directory of Open Access Journals (Sweden)

Giuca Simona-Mihaela

2014-07-01

Full Text Available The current paper has the aim to provide guidelines for designing efficient product and price strategies, through proposed business cases which could be used especially for banking products addressed to SMEs. While identifying the optimal product and price strategy and designing the product catalogue structure, the marketing specialist should definitely consider existing portfolio behaviour and estimate the growing potential (if possible, overall portfolio, with focus on accurately defining the additional impact of the newly proposed product/ products. A business case contains estimations for results to be generated by products to be launched or optimized. This paper presents complex schemes for business case scenarios for migration of existing portfolio to the new products, but also considers new clients acquisition based on important features of the products. The pricing strategy is not a simple task to manage. Especially when speaking about transactional packages (for which the price is lower than separate services included, some segments or clusters may generate loss to the bank if they already used the services at a higher price than the one of the package. Therefore, the decision of setting up specific prices needs to be based on an accurate and complex analysis, as presented in current paper. The assumptions used in a business case need to be relevant for the entire process of designing and launching a product, therefore they can always be adjusted for better calculation of the impact. No matter if the assumptions and prices remain as in the initial proposal or not, the steps to be followed are the same. Segmentation also plays an important role in designing the product strategy, since the target for a product or product catalogue can be represented by a segment, a sub segment or a cluster of many segments. Not always the initial segmentation represents the clustering for the product strategy. Sometimes, behaviour of existing clients

phMRI: methodological considerations for mitigating potential confounding factors

Directory of Open Access Journals (Sweden)

Julius H Bourke

2015-05-01

Full Text Available Pharmacological Magnetic Resonance Imaging (phMRI is a variant of conventional MRI that adds pharmacological manipulations in order to study the effects of drugs, or uses pharmacological probes to investigate basic or applied (e.g. clinical neuroscience questions. Issues that may confound the interpretation of results from various types of phMRI studies are briefly discussed, and a set of methodological strategies that can mitigate these problems are described. These include strategies that can be employed at every stage of investigation, from study design to interpretation of resulting data, and additional techniques suited for use with clinical populations are also featured. Pharmacological MRI is a challenging area of research that has both significant advantages and formidable difficulties, however with due consideration and use of these strategies many of the key obstacles can be overcome.

Sustainability Concept in Decision-Making: Carbon Tax Consideration for Joint Product Mix Decision

OpenAIRE

Wen-Hsien Tsai; Jui-Chu Chang; Chu-Lun Hsieh; Tsen-Shu Tsaur; Chung-Wei Wang

2016-01-01

Carbon emissions are receiving greater scrutiny in many countries due to international forces to reduce anthropogenic global climate change. Carbon taxation is one of the most common carbon emission regulation policies, and companies must incorporate it into their production and pricing decisions. Activity-based costing (ABC) and the theory of constraints (TOC) have been applied to solve product mix problems; however, a challenging aspect of the product mix problem involves evaluating joint m...

Retirement-from-sport considerations following pediatric sports-related concussion: case illustrations and institutional approach.

Science.gov (United States)

Ellis, Michael J; McDonald, Patrick J; Cordingley, Dean; Mansouri, Behzad; Essig, Marco; Ritchie, Lesley

2016-04-01

The decision to advise an athlete to retire from sports following sports-related concussion (SRC) remains a persistent challenge for physicians. In the absence of strong empirical evidence to support recommendations, clinical decision making must be individualized and should involve a multidisciplinary team of experts in concussion and traumatic brain injury. Although previous authors have advocated for a more conservative approach to these issues in child and adolescent athletes, there are few reports outlining considerations for this process among this unique population. Here, the authors use multiple case illustrations to discuss 3 subgroups of clinical considerations for sports retirement among pediatric SRC patients including the following: those with structural brain abnormalities identified on neuroimaging, those presenting with focal neurological deficits and abnormalities on physical examination, and those in whom the cumulative or prolonged effects of concussion are suspected or demonstrated. The authors' evolving multidisciplinary institutional approach to return-to-play and retirement decision making in pediatric SRC is also presented.

Analysis of the production of scientific literature in clinical research areas in Physiotherapy between 2005 and 2009

Directory of Open Access Journals (Sweden)

Torres-Narváez Martha

2012-04-01

Full Text Available Objective: characterize the behavior of clinical research in Physiotherapy, through the analysis of theproduction of scientific literature in a period of five years in order to identify areas of concentrationand dispersion, collaborative research and types of clinical studies have conducted. Methods andmaterials: descriptive study on the papers in Medline/PubMed from 2005-2009. Were considereda total 404 publications, clinical trials and epidemiological studies side, analyzed according to thepercentage distribution of articles by clinical area, year of publication, and institutional affiliation ofresearchers. Results: It found a greater number of trials (93% systematic reviews represented thegreatest number of epidemiological studies side. The clinical areas pulmonary and cardiovascularaccount for 65% of scientific publications in the studies analyzed. The year with highest numberof publications was 2008. Half of the clinical research produced in this five-year have affiliationwith academic institutions, and secondly, studies conducted in hospitals. Conclusions: the clinicalresearch publications in Physiotherapy in Medline/PubMed registered show sustained activity ofscientific production in the pulmonary and cardiovascular areas, consistent with the major healthconcerns in the world. The findings suggest that the ability of physiotherapists to develop qualityresearch, use and transfer of results into clinical practice should achieve greater development.

75 FR 53701 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01...

Science.gov (United States)

2010-09-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0394] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01); Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug...

Prevalence and impact of extended-spectrum β-lactamase production on clinical outcomes in cancer patients with Enterobacter species bacteremia.

Science.gov (United States)

Kim, Sun Jong; Park, Ki-Ho; Chung, Jin-Won; Sung, Heungsup; Choi, Seong-Ho; Choi, Sang-Ho

2014-09-01

We examined the prevalence of extended-spectrum β-lactamase (ESBL) production and the impact of ESBL on clinical outcomes in cancer patients with Enterobacter spp. bacteremia. Using prospective cohort data on Enterobacter bacteremia obtained between January 2005 and November 2008 from a tertiary care center, the prevalence and clinical impact of ESBL production were evaluated. Two-hundred and three episodes of Enterobacter spp. bacteremia were identified. Thirty-one blood isolates (15.3%, 31/203) scored positive by the double-disk synergy test. Among 17 isolates in which ESBL genes were detected by polymerase chain reaction and sequencing, CTX-M (n = 12), SHV-12 (n = 11), and TEM (n = 4) were the most prevalent ESBL types. Prior usage of antimicrobial agents (77.4% vs. 54.0%, p = 0.02) and inappropriate empirical antimicrobial therapy (22.6% vs. 3.0%, p Enterobacter bacteremia. Although inappropriate empirical therapy was more common in the ESBL-positive group, ESBL production was not associated with poorer outcomes.

Endocrine therapy for breast cancer prevention in high-risk women: clinical and economic considerations.

Science.gov (United States)

Groom, Amy G; Younis, Tallal

2016-01-01

The global burden of breast cancer highlights the need for primary prevention strategies that demonstrate both favorable clinical benefit/risk profile and good value for money. Endocrine therapy with selective estrogen-receptor modulators (SERMs) or aromatase inhibitors (AIs) has been associated with a favorable clinical benefit/risk profile in the prevention of breast cancer in women at high risk of developing the disease. The available endocrine therapy strategies differ in terms of their relative reductions of breast cancer risk, potential side effects, and upfront drug acquisition costs, among others. This review highlights the clinical trials of SERMs and AIs for the primary prevention of breast cancer, and the cost-effectiveness /cost-utility studies that have examined their "value for money" in various health care jurisdictions.

Grace under fire: aesthetic leadership in clinical nursing.

Science.gov (United States)

Mannix, Judy; Wilkes, Lesley; Daly, John

2015-09-01

This paper reports the results of an online descriptive survey that sought to determine nurses' perceptions of aesthetic leadership among clinical leaders in nursing. Clinical leadership has been identified as an essential component to ensuring the delivery of safe, high-quality health care. Leadership has been increasingly linked in the literature to aesthetics. However, little consideration has been given to aesthetics in relation to clinical leadership in nursing. A mixed-method, online descriptive survey. Participants were recruited via e-learning platforms and social media. A total of 66 surveys were completed, including 31 written accounts of aesthetic leadership in practice. Aesthetic leadership characteristics in clinical leaders most valued are support, communication and the approach taken to colleagues. Taking risks and challenging processes were least likely to be evident among effective clinical leaders. Aesthetic leadership is multi-dimensional and a style of leadership to positively influence the clinical workplace. Support, effective communication and taking into consideration the feelings of colleagues are important dimensions of aesthetic leadership. Aesthetic leadership represents a way for clinical leaders to create and sustain a calm and positive clinical workplace. © 2015 John Wiley & Sons Ltd.

Medical cannabis: considerations for the anesthesiologist and pain physician.

Science.gov (United States)

Beaulieu, Pierre; Boulanger, Aline; Desroches, Julie; Clark, Alexander J

2016-05-01

New regulations are in place at the federal and provincial levels in Canada regarding the way medical cannabis is to be controlled. We present them together with guidance for the safe use of medical cannabis and recent clinical trials on cannabis and pain. The new Canadian regulations on the use of medical cannabis, the provincial regulations, and the various cannabis products available from the Canadian Licensed Producers were reviewed from Health Canada, provincial licensing authorities, and the licensed producers website, respectively. Recent clinical trials on cannabis and pain were reviewed from the existing literature. Health Canada has approved a new regulation on medical marijuana/cannabis, the Marihuana for Medical Purposes Regulations: The production of medical cannabis by individuals is illegal. Health Canada, however, has licensed authorized producers across the country, limiting the production to specific licenses of certain cannabis products. There are currently 26 authorized licensed producers from seven Canadian provinces offering more than 200 strains of marijuana. We provide guidance for the safe use of medical cannabis. The recent literature indicates that currently available cannabinoids are modestly effective analgesics that provide a safe, reasonable therapeutic option for managing chronic non-cancer-related pain. The science of medical cannabis and the need for education of healthcare professionals and patients require continued effort. Although cannabinoids work to decrease pain, there is still a need to confirm these beneficial effects clinically and to exploit them with acceptable benefit-to-risk ratios.

46 CFR 114.550 - Special consideration.

Science.gov (United States)

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Special consideration. 114.550 Section 114.550 Shipping... consideration. In applying the provisions of this subchapter, the OCMI may give special consideration to... vessel operates must approve any special consideration granted to the vessel. ...

Target validation: linking target and chemical properties to desired product profile.

Science.gov (United States)

Wyatt, Paul G; Gilbert, Ian H; Read, Kevin D; Fairlamb, Alan H

2011-01-01

The discovery of drugs is a lengthy, high-risk and expensive business taking at least 12 years and is estimated to cost upwards of US$800 million for each drug to be successfully approved for clinical use. Much of this cost is driven by the late phase clinical trials and therefore the ability to terminate early those projects destined to fail is paramount to prevent unwanted costs and wasted effort. Although neglected diseases drug discovery is driven more by unmet medical need rather than financial considerations, the need to minimise wasted money and resources is even more vital in this under-funded area. To ensure any drug discovery project is addressing the requirements of the patients and health care providers and delivering a benefit over existing therapies, the ideal attributes of a novel drug needs to be pre-defined by a set of criteria called a target product profile. Using a target product profile the drug discovery process, clinical study design, and compound characteristics can be defined all the way back through to the suitability or druggability of the intended biochemical target. Assessment and prioritisation of the most promising targets for entry into screening programmes is crucial for maximising chances of success.

32 CFR 643.53 - Consideration.

Science.gov (United States)

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Consideration. 643.53 Section 643.53 National... Leases § 643.53 Consideration. (a) Unless otherwise authorized by this regulation or directed by the SA, the consideration for a lease of real estate will be the appraised fair market rental value. However...

28 CFR 51.34 - Expedited consideration.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Expedited consideration. 51.34 Section 51... consideration. (a) When a submitting authority is required under State law or local ordinance or otherwise finds... the submission be given expedited consideration. The submission should explain why such consideration...

Radiobiological considerations in the treatment of neuroblastoma by total body irradiation

International Nuclear Information System (INIS)

Wheldon, T.E.; O'Donoghue, J.; Gregor, A.; Livingstone, A.; Wilson, L.; West of Scotland Health Boards, Glasgow

1986-01-01

Neuroblastoma is a radiosensitive neoplasm for which total body irradiation (TBI) is presently under clinical consideration. Collated data on the radiobiology of human neuroblastoma cells in vitro indicates moderate cellular radiosensitivity and low capacity for accumulation of sublethal damage. Mathematical studies incorporating these parameters suggest that low dose fractionated TBI is unlikely to achieve significant levels of tumour cell kill. When high dose TBI is used in conjuction with bone marrow rescue a tumour 'log cell kill' of 4-5 should be achievable. This effect would be additional to that acheived by chemotherapy. Fractionated TBI with bone marrow rescue may be curative for some patients in clinical remission who are presently destined to relapse. (Auth.)

32 CFR 643.74 - Consideration.

Science.gov (United States)

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Consideration. 643.74 Section 643.74 National... Licenses § 643.74 Consideration. When a license is granted under the authority of an easement or leasing statute, the same rules will apply in regard to consideration as is applicable to the granting of an...

The consideration of health in land use planning: Barriers and opportunities

International Nuclear Information System (INIS)

Burns, Jennifer; Bond, Alan

2008-01-01

This research investigates the consideration of human health effects within the plan-making process in the East of England. It is based primarily upon questionnaires and interviews with those involved in plan-making. The results indicate that, prior to the implementation of the Strategic Environmental Assessment (SEA) Directive, which established a statutory requirement for the consideration of significant effects on human health in European Union member states, very limited consideration has been given to human health in land use plans. The capacity of the planning system to affect human health is clearly understood by those responsible for their production, but they lack the expertise to consider the health implications of their plans. The SEA Directive, along with reforms to the planning system, does provide a framework for improving the consideration of health, but the capacity of the planning system to consider health must be improved as should dialogue with health practitioners, and the evidence base for health outcomes. Also, analytical and methodological complexity may hinder the ability of planners to consider health, indicating that greater application of the precautionary principle is required to deal with the present uncertainty over human health impacts resulting from the implementation of land use plans

Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

Science.gov (United States)

Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

2016-12-01

This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical

Family Caregivers: Psychosocial Impacts and Clinical Needs

Science.gov (United States)

Daire, Andrew P.; Torres, Jennifer; Edwards, Nivischi N.

2009-01-01

The authors describe how 3 groups of family caregivers (spouses, daughters, and sons) are affected by the caregiving role. In addition, clinical considerations and interventions for mental health professionals working with these different groups of family caregivers are discussed. A clinical case example is also presented. (Contains 2 tables.)

Issues and concerns in nanotech product development and its commercialization.

Science.gov (United States)

Kaur, Indu Pal; Kakkar, Vandita; Deol, Parneet Kaur; Yadav, Monika; Singh, Mandeep; Sharma, Ikksheta

2014-11-10

The revolutionary and ubiquitous nature of nanotechnology has fetched it a considerable attention in the past few decades. Even though its enablement and application to various sectors including pharmaceutical drug development is increasing with the enormous government aided funding for nanotechnology-based products, however the parallel commercialization of these systems has not picked up a similar impetus. The technology however does address the unmet needs of pharmaceutical industry, including the reformulation of drugs to improve their solubility, bioavailability or toxicity profiles as observed from the wide array of high-quality research publications appearing in various scientific journals and magazines. Based on our decade-long experience in the field of nanotech-based drug delivery systems and extensive literature survey, we perceive that the major hiccups to the marketing of these nanotechnology products can be categorized as 1) inadequate regulatory framework; 2) lack of support and acceptance by the public, practicing physician, and industry; 3) developmental considerations like scalability, reproducibility, characterization, quality control, and suitable translation; 4) toxicological issues and safety profiles; 5) lack of available multidisciplinary platforms; and, 6) poor intellectual property protection. The present review dwells on these issues elaborating the trends followed by the industry, regulatory role of the USFDA and their implication, and the challenges set forth for a successful translation of these products from the lab and different clinical phases to the market. Copyright © 2014 Elsevier B.V. All rights reserved.

Primary melanoma lung purposely clinico pathologic considerations of a clinical case

International Nuclear Information System (INIS)

Rodríguez, R.; Roldán, G.; Sosa, A.; Mañana, G.; Rodríguez, A.; Panuncio, A.

2004-01-01

Introduction: There are few reports of primary malignant melanomas (M M) of visceral organs, general case of metastatic cutaneous and ocular M M regression suffering go unnoticed or diagnosis. Cases of lung primary melanomas (MPP) that meet the clinico pathologic to be considered as such criteria constitute about 0.01% lung tumors and are published as individual case analysis is impossible series of patients. These criteria are under constant review, constituting a field permanent controversial.Materials and method: A case review of the clinical literature on the most relevant of MPP clinico pathological aspects is performed. Case: This is a patient (Pt), 58 years old, smoker, who consults for elements progressive intracranial hypertension installation without other symptoms to note. the Computed tomography (CT) of the skull shows an expansive process only right temporal. Radiography and CT of the chest then show a right parahiliar single nodule without liver involvement without mediastinal symphadenopathy. Flexible bronchoscopy and bronchial brushing are negative. With the proposition that it is a bearer of a lung carcinoma with second only symptomatic brain macroscopically complete resection is performed head injury. The pathology reports that metastasis is a M M. Is discarded the presence of other injuries, especially to skin and eye. Receive brain radiotherapy and a right lower lobectomy whose analysis confirms that this is a M M is performed and that no there are other lesions in the resected lobe. Analyzed the cost / benefit profile indication treatment (t to) with systemic disease in the absence of other obvious injuries continues regular clinical exams. Remained asymptomatic for 5 months relapsing to brain level no new lesions in the lungs. The p te refuses to receive palliative systemic t to reaching, to the presentation of this work, a survival of 11 months. Discussion: Within the clinical criteria that state that is an MPP, the absence of a history of

Radiation safety considerations and compliance within equine veterinary clinics: Results of an Australian survey

International Nuclear Information System (INIS)

Surjan, Y.; Ostwald, P.; Milross, C.; Warren-Forward, H.

2015-01-01

Objective: To examine current knowledge and the level of compliance of radiation safety principles in equine veterinary clinics within Australia. Method: Surveys were sent to equine veterinary surgeons working in Australia. The survey was delivered both online and in hardcopy format; it comprised 49 questions, 15 of these directly related to radiation safety. The participants were asked about their current and previous use of radiation-producing equipment. Information regarding their level of knowledge and application of radiation safety principles and practice standards was collected and analysed. Results: The use of radiation-producing equipment was evident in 94% of responding clinics (a combination of X-ray, CT and/or Nuclear Medicine Cameras). Of those with radiation-producing equipment, 94% indicated that they hold a radiation licence, 78% had never completed a certified radiation safety course and 19% of participants did not use a personal radiation monitor. In 14% of cases, radiation safety manuals or protocols were not available within clinics. Conclusions: The study has shown that knowledge and application of guidelines as provided by the Code of Practice for Radiation Protection in Veterinary Medicine (2009) is poorly adhered to. The importance of compliance with regulatory requirements is pivotal in minimising occupational exposure to ionising radiation in veterinary medicine, thus there is a need for increased education and training in the area. - Highlights: • Application of the Code of Practice for Veterinary Medicine is poorly adhered to. • Majority of veterinary clinics had not completed certified radiation safety course. • One-fifth of participants did not use personal radiation monitoring. • Increased education and training in area of radiation safety and protection required to generate compliance in clinics

Consideration on the history and the stylistic use of prefixes

Directory of Open Access Journals (Sweden)

Antonio Carlos Silva de Carvalho

2016-07-01

Full Text Available This paper aims to discuss prefixes from a historical perspective, as well as to observe nuances of stylistic value in them. The choice of subject was basically due to two reasons: (i the considerations set out by Martins (2003 on the low stylistic productivity caused by prefixal derivation – especially if compared to suffixal derivation; and (ii the considerations set out by Silva (2009 on the so-called de-language, of negativity, in Manoel de Barros. At first we worked on a brief historically and etymologically-oriented incursion on prefixes; and then, subjecting the reflections we gathered to a punctual corpus by the author, we highlighted examples in which features of the morpho-stylistic nature that contribute to the singularity of his work, also linked to the aesthetics of the fragmentary and to the smallest beings, can be explored.

Considerations in implementing integrated biomass energy systems in developing countries

International Nuclear Information System (INIS)

Perlack, R.D.; Ranney, J.W.

1993-01-01

Biomass energy is emerging as a real option for satisfying power needs in developing countries. Experience has shown improvements in GDP are directly linked to increased consumption of energy. Biomass energy can also be environmentally and developmentally beneficial where it will be both grown and used. Biomass production can offset deforestation, reduce soil erosion, increase rural employment, and stimulate development. Moreover, when biomass is grown renewably there is no net buildup of atmospheric carbon. Issues and barriers associated with implementing integrated biomass energy systems in developing countries are discussed. An integrated biomass energy system is dependent on sustainably grown and managed energy crops, supportive of rural development, and environmentally beneficial, adapted to local conditions; takes advantage of by- and co-products and uses conversion technologies that have been optimized for biomass. A preliminary evaluation of a biomass to electricity project relying on plantation grown feedstocks in Southwest China indicates that biomass could be grown and converted to electricity at costs lower than alternatives and yield an internal rate of return of about 15%. The IRR based on a social and environmental benefits are substantial and investment in the facility is well-justified. However, assessing biomass energy systems is exceedingly complex. Considerations are grouped into biomass production, biomass logistics and transport, and biomass conversion. Implementation requires considerations of energy and economics, institutional and social issues, and environmental issues. The conclusion that such a project would be viable in rural China is shadowed by many site-specific circumstances and highlights the need for systematic and integrated appraisal

Ethical considerations of neuro-oncology trial design in the era of precision medicine.

Science.gov (United States)

Gupta, Saksham; Smith, Timothy R; Broekman, Marike L

2017-08-01

The field of oncology is currently undergoing a paradigm shift. Advances in the understanding of tumor biology and in tumor sequencing technology have contributed to the shift towards precision medicine, the therapeutic framework of targeting the individual oncogenic changes each tumor harbors. The success of precision medicine therapies, such as targeted kinase inhibitors and immunotherapies, in other cancers have motivated studies in brain cancers. The high specificity and cost of these therapies also encourage a shift in clinical trial design away from randomized control trials towards smaller, more exclusive early phase clinical trials. While these new trials advance the clinical application of increasingly precise and individualized therapies, their design brings ethical challenges . We review the pertinent ethical considerations for clinical trials of precision medicine in neuro-oncology and discuss methods to protect patients in this new era of trial design.

Production of {sup 177}Lu for targeted radionuclide therapy: Available options

Energy Technology Data Exchange (ETDEWEB)

Dah, Ashutosh [Isotope Production and Applications Division, Bhabha Atomic Research Centre (BARC), Mumbai (India); Pillai, Maroor Raghavan Ambikalmajan [Molecular Group of Companies. Kerala (India); Knapp, Furn F. Jr. [Medical Isotopes Program, Isotope Dept. Group, Oak Ridge National Laboratory (ORNL), Oak Ridge (United States)

2015-06-15

This review provides a comprehensive summary of the production of {sup 177}Lu to meet expected future research and clinical demands. Availability of options represents the cornerstone for sustainable growth for the routine production of adequate activity levels of {sup 177}Lu having the required quality for preparation of a variety of {sup 177}Lu-labeled radiopharmaceuticals. The tremendous prospects associated with production of {sup 177}Lu for use in targeted radionuclide therapy (TRT) dictate that a holistic consideration should evaluate all governing factors that determine its success. While both “direct” and “indirect” reactor production routes offer the possibility for sustainable {sup 177}Lu availability, there are several issues and challenges that must be considered to realize the full potential of these production strategies. This article presents a mini review on the latest developments, current status, key challenges and possibilities for the near future. A broad understanding and discussion of the issues associated with {sup 177}Lu production and processing approaches would not only ensure sustained growth and future expansion for the availability and use of {sup 177}Lu-labeled radiopharmaceuticals, but also help future developments.

Towards Sustainability-driven Innovation through Product Service Systems

OpenAIRE

Thompson, Anthony

2010-01-01

Increasing awareness of anthropogenic impacts on the planet has lead to efforts to reduce negative environmental impacts in product development for several decades. Benefits to companies who focus on sustainability initiatives have been put forth more recently, leading to many efforts to incorporate sustainability considerations in their product innovation processes. The majority of current sustainability considerations in industry constrain design space by emphasizing reduced material and en...

The cost of clinical mastitis in the first 30 days of lactation: An economic modeling tool.

Science.gov (United States)

Rollin, E; Dhuyvetter, K C; Overton, M W

2015-12-01

Clinical mastitis results in considerable economic losses for dairy producers and is most commonly diagnosed in early lactation. The objective of this research was to estimate the economic impact of clinical mastitis occurring during the first 30 days of lactation for a representative US dairy. A deterministic partial budget model was created to estimate direct and indirect costs per case of clinical mastitis occurring during the first 30 days of lactation. Model inputs were selected from the available literature, or when none were available, from herd data. The average case of clinical mastitis resulted in a total economic cost of $444, including $128 in direct costs and $316 in indirect costs. Direct costs included diagnostics ($10), therapeutics ($36), non-saleable milk ($25), veterinary service ($4), labor ($21), and death loss ($32). Indirect costs included future milk production loss ($125), premature culling and replacement loss ($182), and future reproductive loss ($9). Accurate decision making regarding mastitis control relies on understanding the economic impacts of clinical mastitis, especially the longer term indirect costs that represent 71% of the total cost per case of mastitis. Future milk production loss represents 28% of total cost, and future culling and replacement loss represents 41% of the total cost of a case of clinical mastitis. In contrast to older estimates, these values represent the current dairy economic climate, including milk price ($0.461/kg), feed price ($0.279/kg DM (dry matter)), and replacement costs ($2,094/head), along with the latest published estimates on the production and culling effects of clinical mastitis. This economic model is designed to be customized for specific dairy producers and their herd characteristics to better aid them in developing mastitis control strategies. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

Science.gov (United States)

Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

2015-05-01

A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Practical considerations for maximizing heat production in a novel thermobrachytherapy seed prototype

Energy Technology Data Exchange (ETDEWEB)

Gautam, Bhoj; Warrell, Gregory; Shvydka, Diana; Ishmael Parsai, E., E-mail: e.parsai@utoledo.edu [University of Toledo Medical Center, 3000 Arlington Avenue, MS1151, Toledo, Ohio 43614 (United States); Subramanian, Manny [BEST Medical International, Inc., 7643 Fullerton Road, Springfield, Virginia 22153 (United States)

2014-02-15

Purpose: A combination of hyperthermia and radiation in the treatment of cancer has been proven to provide better tumor control than radiation administered as a monomodality, without an increase in complications or serious toxicities. Moreover, concurrent administration of hyperthermia and radiation displays synergistic enhancement, resulting in greater tumor cell killing than hyperthermia and radiation delivered separately. The authors have designed a new thermobrachytherapy (TB) seed, which serves as a source of both radiation and heat for concurrent brachytherapy and hyperthermia treatments when implanted in solid tumors. This innovative seed, similar in size and geometry to conventional seeds, will have self-regulating thermal properties. Methods: The new seed's geometry is based on the standard BEST Model 2301{sup 125}I seed, resulting in very similar dosimetric properties. The TB seed generates heat when placed in an oscillating magnetic field via induction heating of a ferromagnetic Ni–Cu alloy core that replaces the tungsten radiographic marker of the standard Model 2301. The alloy composition is selected to undergo a Curie transition near 50 °C, drastically decreasing power production at higher temperatures and providing for temperature self-regulation. Here, the authors present experimental studies of the magnetic properties of Ni–Cu alloy material, the visibility of TB seeds in radiographic imaging, and the ability of seed prototypes to uniformly heat tissue to a desirable temperature. Moreover, analyses are presented of magnetic shielding and thermal expansion of the TB seed, as well as matching of radiation dose to temperature distributions for a short interseed distance in a given treatment volume. Results: Annealing the Ni–Cu alloy has a significant effect on its magnetization properties, increasing the sharpness of the Curie transition. The TB seed preserves the radiographic properties of the BEST 2301 seed in both plain x rays and CT

Practical considerations for maximizing heat production in a novel thermobrachytherapy seed prototype

International Nuclear Information System (INIS)

Gautam, Bhoj; Warrell, Gregory; Shvydka, Diana; Ishmael Parsai, E.; Subramanian, Manny

2014-01-01

Purpose: A combination of hyperthermia and radiation in the treatment of cancer has been proven to provide better tumor control than radiation administered as a monomodality, without an increase in complications or serious toxicities. Moreover, concurrent administration of hyperthermia and radiation displays synergistic enhancement, resulting in greater tumor cell killing than hyperthermia and radiation delivered separately. The authors have designed a new thermobrachytherapy (TB) seed, which serves as a source of both radiation and heat for concurrent brachytherapy and hyperthermia treatments when implanted in solid tumors. This innovative seed, similar in size and geometry to conventional seeds, will have self-regulating thermal properties. Methods: The new seed's geometry is based on the standard BEST Model 2301 125 I seed, resulting in very similar dosimetric properties. The TB seed generates heat when placed in an oscillating magnetic field via induction heating of a ferromagnetic Ni–Cu alloy core that replaces the tungsten radiographic marker of the standard Model 2301. The alloy composition is selected to undergo a Curie transition near 50 °C, drastically decreasing power production at higher temperatures and providing for temperature self-regulation. Here, the authors present experimental studies of the magnetic properties of Ni–Cu alloy material, the visibility of TB seeds in radiographic imaging, and the ability of seed prototypes to uniformly heat tissue to a desirable temperature. Moreover, analyses are presented of magnetic shielding and thermal expansion of the TB seed, as well as matching of radiation dose to temperature distributions for a short interseed distance in a given treatment volume. Results: Annealing the Ni–Cu alloy has a significant effect on its magnetization properties, increasing the sharpness of the Curie transition. The TB seed preserves the radiographic properties of the BEST 2301 seed in both plain x rays and CT images

Report of an exploratory study: Safety and liability considerations for photovoltaic modules/panels

Science.gov (United States)

Weinstein, A. S.; Meeker, D. G.

1981-01-01

An overview of legal issues as they apply to design, manufacture and use of photovoltaic module/array devices is provided and a methodology is suggested for use of the design stage of these products to minimize or eliminate perceived hazards. Questions are posed to stimulate consideration of this area.

Clinical and histopathologic features of dorsally located furunculosis in dogs following water immersion or exposure to grooming products: 22 cases (2005-2013).

Science.gov (United States)

Cain, Christine L; Mauldin, Elizabeth A

2015-03-01

To describe clinical and histopathologic features of furunculosis in dogs following water immersion or exposure to grooming products. Retrospective case series. 22 dogs with skin lesions consistent with furunculosis and a history of water immersion or grooming prior to onset. Procedures-Information collected from the medical records of affected dogs included signalment, clinical signs, bathing or grooming procedure, diagnostic tests, treatment, and outcome. German Shepherd Dogs (4/22 [18%]) and Labrador Retrievers (4/22 [18%]) were most commonly affected. Skin lesions, particularly hemorrhagic pustules and crusts, were dorsally located in all dogs and occurred a median of 2 days (range, 1 to 7 days) following water immersion or exposure to grooming products. Twenty (91%) dogs were bathed at home or at a commercial grooming facility prior to lesion onset; 1 dog developed skin lesions following hydrotherapy on an underwater treadmill, and 1 dog developed peri-incisional skin lesions after surgery. Lethargy, signs of neck or back pain, and fever were common clinical signs. Pseudomonas aeruginosa was the most common bacterial isolate from dogs with bacteriologic culture performed on skin samples (10/14). The main histologic feature was acute follicular rupture in the superficial dermis with suppurative inflammation and dermal hemorrhage. Systemic antimicrobial treatment, particularly oral administration of fluoroquinolones, resulted in excellent clinical response in 16 of 22 (73%) dogs. Acute-onset furunculosis with characteristic clinical and histopathologic features in dogs following water immersion or exposure to grooming products was described. Knowledge of the historical and clinical features of this syndrome is essential for accurate diagnosis and appropriate treatment of affected dogs.

An audit of health products advertised for sale on chiropractic Web sites in Canada and consideration of these practices in the context of Canadian chiropractic codes of ethics and conduct.

Science.gov (United States)

Page, Stacey A; Grod, Jaroslaw P

2009-01-01

This study describes the extent to which chiropractors with Web sites practicing in Canada advertise health products for sale and considers this practice in the context of chiropractic codes of ethics and conduct. Chiropractic Web sites in Canada were identified using a public online business directory (Canada 411). The Web sites were searched, and an inventory of the health products for sale was taken. The influences of type of practice and province of practice on the sale of health product were assessed. Textual comments about health product marketing were summarized. National and provincial codes of ethics were reviewed, and the content on health product advertising was summarized. Two hundred eighty-seven Web sites were reviewed. Just more than half of the Web sites contained information on health products for sale (n = 158, 54%). Orthotics were advertised most often (n = 136 practices, 47%), followed by vitamins/nutritional supplements (n = 53, 18%), pillows and supports (n = 40, 14%), and exercise/rehabilitation products (n = 20, 7%). Chiropractors in solo or group chiropractic practices were less likely to advertise health products than those in multidisciplinary practice (P advertise nutritional supplements (P ethics and conduct varied in their guidelines regarding health product sales. Variations in codes of ethics and in the proportions of practitioners advertising health products for sales across the country suggest that opinions may be divided on the acceptability of health product sales. Such practices raise questions and considerations for the chiropractic profession.

Design for Additive Manufacturing: Trends, opportunities, considerations, and constraints

DEFF Research Database (Denmark)

Thompson, Mary Kathryn; Moroni, Giovanni; Vaneker, Tom

2016-01-01

The past few decades have seen substantial growth in Additive Manufacturing (AM) technologies. However, this growth has mainly been process-driven. The evolution of engineering design to take advantage of the possibilities afforded by AM and to manage the constraints associated with the technology...... has lagged behind. This paper presents the major opportunities, constraints, and economic considerations for Design for Additive Manufacturing. It explores issues related to design and redesign for direct and indirect AM production. It also highlights key industrial applications, outlines future...

Design for Additive Manufacturing: Trends, opportunities, considerations, and constraints

DEFF Research Database (Denmark)

Thompson, Mary Kathryn; Moroni, Giovanni; Vaneker, Tom

2016-01-01

has lagged behind. This paper presents the major opportunities, constraints, and economic considerations for Design for Additive Manufacturing. It explores issues related to design and redesign for direct and indirect AM production. It also highlights key industrial applications, outlines future......The past few decades have seen substantial growth in Additive Manufacturing (AM) technologies. However, this growth has mainly been process-driven. The evolution of engineering design to take advantage of the possibilities afforded by AM and to manage the constraints associated with the technology...

Dissecting aneurysms of posterior communicating artery itself: anatomical, diagnostic, clinical, and therapeutical considerations.

Science.gov (United States)

Kocak, Burak; Tureci, Ercan; Kizilkilic, Osman; Islak, Civan; Kocer, Naci

2013-09-01

Posterior communicating artery (PCoA) itself is an unusual location for intracranial aneurysms in that isolated dissections or dissecting aneurysms are extremely rare. In the way of correct diagnosis of dissecting aneurysms of PCoA itself, a proper understanding of (1) the anatomy of the PCoA and its perforator branches, (2) some particular diagnostic features, and (3) related clinical aspects is of significant importance. Although there are no established treatment strategies for this particular type of aneurysms, the endovascular approach might be considered as a plausible one. In this paper, our scope was to report five cases with dissecting aneurysm of the PCoA itself and to discuss this rare vascular pathology from anatomical, diagnostic, clinical, and therapeutical perspectives.

Integrating Environmental Sustainability Considerations into Food and Nutrition Policies: Insights from Australia's National Food Plan.

Science.gov (United States)

Ridgway, Ella Megan; Lawrence, Mark Andrew; Woods, Julie

2015-01-01

The environmental sustainability (ES) of food systems is a critical challenge for policy makers. This is a highly contested policy area with differing views among stakeholders. The aim of the study was to develop a better understanding of how ES considerations are addressed in Australian food and nutrition policies and the way that consultation processes affect final policy outcomes. A mixed-methods study design combined a detailed chronology of key policy developments (2009-2015), a content analysis of written submissions obtained during the NFP's consultation period (2011-2013) and a frame analysis of the sustainability perspectives - efficiency, demand restraint, and system transformation - in the NFP's Issues, Green, and White Papers. There were 555 written submissions responding to two consultation papers. Stakeholders represented all sectors of Australia's food system including government, non-government organizations, the food supply chain, research and academic institutions, and members of the general public. Around 74% of submissions referred to ES considerations and ~65% supported their inclusion into the final policy. Efficiency frames were most dominant; emphasizing a production-oriented approach that regards the environment as a natural resource base for food production but overlooks consumption and equity concerns. Despite strong support for the inclusion of ES considerations in the NFP, the influence of Australia's socio-political context, powerful, industry-dominated stakeholders, and a reliance on traditional production-oriented perspectives delivered a business-as-usual approach to food policy making. It has since been replaced by an agricultural strategy that provides only cursory attention to ES. Our findings indicate that Australia's political environment is not sufficiently mature for ES considerations to be integrated into food and nutrition policies. We propose reforms to the current consultation process in Australia to better support this

Maintaining human productivity during Mars transit

Science.gov (United States)

Statler, Irving C.; Billings, Charles E.

1989-01-01

This paper addresses the special nature of the human-machine relationship during a trip to Mars. In particular, the potential for monotony and boredom during a long-duration space voyage and the effect on motivation and productivity can be important considerations to the health and welfare of the crew. For the voyage to Mars, a design may be considered that will purposefully maintain some level of workload for the crew as a preventive measure for the deterioration of productivity that comes with boredom. This paper speculates on these considerations, on the appropriate level of workload for maximum productivity, and on what might be done during the mission to alleviate the problems caused by monotony and boredom.

The Sino-American belt study: nickel and cobalt exposure, epidemiology, and clinical considerations.

Science.gov (United States)

Hamann, Dathan; Hamann, Carsten; Li, Lin-Feng; Xiang, Hailian; Hamann, Kylin; Maibach, Howard; Taylor, James S; Thyssen, Jacob P

2012-01-01

Nickel and cobalt are common causes of metal allergy. The objective of this study was to investigate nickel and cobalt exposure in belt buckles by testing 701 belts purchased in China and the United States and to consider the prevalence of nickel allergy and its relevance among Chinese patients. Seven hundred one belt buckles purchased in China and the United States were tested for nickel and cobalt release. Six hundred thirty-one Chinese patients with suspected allergic contact dermatitis were patch tested and interviewed to determine clinical relevance of results. The Chinese and American literature was reviewed to investigate trends in nickel prevalence over the past decades. Sixty percent (n = 219) of belts purchased in China (n = 365) released nickel, and 0.5% (n = 2) released cobalt; 55.7% (n = 187) in the United States (n = 336) released nickel, and 0.9% (n = 3) released cobalt. Belt dermatitis was a significant clinical finding in 34.8% of Chinese nickel-allergic patients. Literature review suggests increasing nickel allergy prevalence in the United States and China. Metallic belt buckles are an important source of nickel exposure to consumers. Belts from lowest socioeconomic vendors were more likely to release nickel. Belts with silver color and dark metallic color were more likely to release nickel and cobalt, respectively. Clinical findings show belt dermatitis in China to be a problem.

Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials.

Science.gov (United States)

Ott, Mary A; Crawley, Francis P; Sáez-Llorens, Xavier; Owusu-Agyei, Seth; Neubauer, David; Dubin, Gary; Poplazarova, Tatjana; Begg, Norman; Rosenthal, Susan L

2018-06-01

Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12-14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.

Clinical Trials

Medline Plus

Full Text Available ... Some companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

Considerations for high-brightness electron sources

International Nuclear Information System (INIS)

Jameson, R.A.

1990-01-01

Particle accelerators are now used in many areas of physics research and in industrial and medical applications. New uses are being studied to address major societal needs in energy production, materials research, generation of intense beams of radiation at optical and suboptical wavelengths, treatment of various kinds of waste, and so on. Many of these modern applications require a high intensity beam at the desired energy, along with a very good beam quality in terms of the beam confinement, aiming, or focusing. Considerations for ion and electron accelerators are often different, but there are also many commonalties, and in fact, techniques derived for one should perhaps more often be considered for the other as well. We discuss some aspects of high-brightness electron sources here from that point of view. 6 refs

The green and blue water footprint of paper products: methodological considerations and quantification

NARCIS (Netherlands)

van Oel, P.R.; Hoekstra, Arjen Ysbert

2010-01-01

For a hardcopy of this report, printed in the Netherlands, an estimated 200 litres of water have been used. Water is required during different stages in the production process, from growing wood to processing pulp into the final consumer product. Most of the water is consumed in the forestry stage,

The integrated control of production-inventory systems

NARCIS (Netherlands)

Nyen, van P.L.M.

2005-01-01

In this thesis, we investigate a multi-product, multi-machine production-inventory (PI) system that is characterized by: ?? relatively high and stable demand; ?? uncertainty in the precise timing of demand; ?? variability in the production process; ?? job shop routings; ?? considerable setup times

Evaluation of oral hygiene products: science is true; don't be misled by the facts.

Science.gov (United States)

Addy, M; Moran, J M

1997-10-01

Most people in industrialized countries use oral hygiene products. When an oral health benefit is expected, it is important that sufficient scientific evidence exist to support such claims. Ideally, data should be cumulative derived from studies in vitro and in vivo. The data should be available to the profession for evaluation by publication in refereed scientific journals. Terms and phrases require clarification, and claims made by implication or derived by inference must be avoided. Similarity in products is not necessarily proof per se of efficacy. Studies in vitro and in vivo should follow the basic principles of scientific research. Studies must be ethical, avoid bias and be suitably controlled. A choice of controls will vary depending on whether an agent or a whole product is evaluated and the development stage of a formulation. Where appropriate, new products should be compared with products already available and used by the general public. Conformity with the guidelines for good clinical practice appears to be a useful way of validating studies and a valuable guide to the profession. Studies should be designed with sufficient power to detect statistically significant differences if these exist. However, consideration must be given to the clinical significance of statistically significant differences between formulations since these are not necessarily the same. Studies in vitro provide supportive data but extrapolation to clinical effect is difficult and even misleading, and such data should not stand alone as proof of efficacy of a product. Short-term studies in vivo provide useful information, particularly at the development stage. Ideally, however, products should be proved effective when used in the circumstances for which they are developed. Nevertheless, a variety of variable influence the outcome of home-use studies, and the influence of the variable cannot usually be calculated. Although rarely considered, the cost-benefit ratio of some oral

Considerations and controversies in the selection of radiopharmaceuticals

International Nuclear Information System (INIS)

Chilton, H.M.; Cowan, R.J.

1987-01-01

When a radiopharmaceutical is selected for a specific study, multiple factors must be considered to ensure that optimum clinical information will be provided with minimum radiation exposure to the patient and laboratory personnel. In this endeavor, certain questions must be considered. What are the nuclear properties of the available radiopharmaceuticals? For the organ to be studied, are there multiple radiopharmaceutical localization pathways? If so, which is best suited to provide the desired diagnostic information? Does the presence of certain clinical factors preclude the use of some radiopharmaceuticals and require the use of others? Do certain radiopharmaceuticals have overriding radiopharmacologic properties which limit their usefulness for the evaluation of certain clinical situations? Finally, how significant are non-clinical properties such as cost, availability, and product formulation? In this chapter, some of these areas and several situations which illustrate the radiopharmaceutical selection process are discussed

Key feasibility considerations when conducting vaccine clinical trials in Asia–Pacific countries

Directory of Open Access Journals (Sweden)

Lansang EZ

2013-03-01

Full Text Available Elvira Zenaida Lansang,1 Kenneth Tan,2 Saumya Nayak,1 Ken J Lee,1 Karen Wai1 1Feasibility and Site Identification – Asia, Quintiles East Asia Pte Ltd, Singapore; 2National University of Singapore, Singapore Introduction: Conducting clinical trial feasibility is an important first step in initiating a clinical trial. A robust feasibility process ensures that a realistic capability assessment is made before conducting a trial. A retrospective analysis of vaccine clinical trials was performed to understand changes which could affect feasibility recommendations. Methods: Feasibilities conducted by Quintiles between January 2011 and August 2012 were reviewed. Vaccine studies only involving Asia–Pacific countries were selected, and common study parameters were identified. Information from Quintiles’ database was retrieved to examine changes in parameters over time. Results: A total of six vaccine studies were identified within the 1.7-year period. Two studies were excluded because they did not contain feasibility information or had involved sites that were sponsor selected. Four studies were analyzed. Three cases required healthy volunteers, while one case involved a specific patient population. Age requirement and seasonality of disease mainly influenced recommendations for Study 1. Sponsor’s marketing strategy influenced the recommendations for Study 2. Study 3 showed the effect of a country’s immunization program and reimbursement of vaccines on a study’s success. In contrast to the other studies, Study 4 demonstrated the impact of eligibility criteria in recruitment recommendations for a vaccine trial requiring specific patient pools. Conclusion: Feasibility recommendations for vaccine trials are largely based on (1 eligibility criteria; (2 cultural beliefs; (3 country’s past recruitment performance; (4 use of advertising; (5 site’s access to subject populations; (6 cooperation with local health professionals and government; (7

National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

Science.gov (United States)

Balamurugan, A.N.; Szot, Gregory L.; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W.; Barbaro, Barbara; Bridges, Nancy D.; Cano, Jose; Clarke, William R.; Eggerman, Thomas L.; Hunsicker, Lawrence G.; Kaufman, Dixon B.; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F.; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A.; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S.; Lei, Ji; Wang, Ling-jia; Wilhelm, Joshua J.; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J.; Posselt, Andrew M.; Stock, Peter G.; Shapiro, A.M. James

2016-01-01

Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. PMID:27465220

Interactions of woody biofuel feedstock production systems with water resources: considerations for sustainability

Science.gov (United States)

Carl C. Trettin; Devendra Amatya; Mark Coleman

2008-01-01

Water resources are important for the production of woody biofuel feedstocks. It is necessary to ensure that production systems do not adversely affect the quantity or quality of surface and ground water. The effects of woody biomass plantations on water resources are largely dependent on the prior land use and the management regime. Experience from both irrigated and...

Developing students' time management skills in clinical settings: practical considerations for busy nursing staff.

Science.gov (United States)

Cleary, Michelle; Horsfall, Jan

2011-06-01

In clinical settings, nursing staff often find themselves responsible for students who have varying time management skills. Nurses need to respond sensitively and appropriately, and to teach nursing students how to prioritize and better allocate time. This is important not only for developing students' clinical skills but also for shaping their perceptions about the quality of the placement and their willingness to consider it as a potential work specialty. In this column, some simple, practical strategies that nurses can use to assist students with improving their time management skills are identified. Copyright 2011, SLACK Incorporated.

Production of BMP4 by endothelial cells is crucial for endogenous thymic regeneration

Science.gov (United States)

Wertheimer, Tobias; Velardi, Enrico; Tsai, Jennifer; Cooper, Kirsten; Xiao, Shiyun; Kloss, Christopher C.; Ottmüller, Katja J.; Mokhtari, Zeinab; Brede, Christian; deRoos, Paul; Kinsella, Sinéad; Palikuqi, Brisa; Ginsberg, Michael; Young, Lauren F.; Kreines, Fabiana; Lieberman, Sophia R.; Lazrak, Amina; Guo, Peipei; Malard, Florent; Smith, Odette M.; Shono, Yusuke; Jenq, Robert R.; Hanash, Alan M.; Nolan, Daniel J.; Butler, Jason M.; Beilhack, Andreas; Manley, Nancy R.; Rafii, Shahin; Dudakov, Jarrod A; van den Brink, Marcel RM

2018-01-01

The thymus is extremely sensitive to damage but also has a remarkable ability to repair itself. However, the mechanisms underlying this endogenous regeneration remain poorly understood and this capacity diminishes considerably with age. Here we show that thymic endothelial cells (ECs) comprise a critical pathway of regeneration, via their production of BMP4. ECs increased their production of BMP4 after thymic damage, and abrogating BMP4 signalling or production by either pharmacologic or genetic inhibition impaired thymic repair. EC-derived BMP4 acted on thymic epithelial cells (TECs) to increase their expression of Foxn1, a key transcription factor involved in TEC development, maintenance and regeneration; and its downstream targets such as Dll4, itself a key mediator of thymocyte development and regeneration. These studies demonstrate the importance of the BMP4 pathway in endogenous tissue regeneration and offer a potential clinical approach to enhance T cell immunity. PMID:29330161

Test Operations Procedure (TOP) 01-1-020 Tropical Regions Environmental Considerations

Science.gov (United States)

2013-02-08

to exude tannins , sugars, and other natural plant products, which may support microbial growth and corrosion processes. 2.2 Test Site Severity...Containers in Humid Environments, US Army Tropic Test Center, TECOM Project No. 7-C0-PB5-TT1-004, 1978. 16. A Technical Analysis to Identify Ideal...1973. 37. MIL-STD-810G, Test Method Standard, Environmental Engineering Considerations and Laboratory Tests, 2008. 38. A Technical Analysis

POST-LAUNCHING MONITORING ACTIVITIES FOR NEW TRANSACTIONAL BANKING PRODUCTS ADDRESSED TO SMES (CONSIDERATIONS

Directory of Open Access Journals (Sweden)

Giuca Simona-Mihaela

2014-07-01

Full Text Available The current paper has the aim to provide guidelines for post-launching monitoring activities and steps related to new transactional banking products addressed to SMEs. While the pre-launching activities have the purpose of accurately defining the objectives, assumptions and estimations, the purpose of the post-launching plan is to identify: if the final objectives of a product launching have been met, on one hand, to analyze results in the sense of identifying an efficient action plan in order to overcome the lack of results (if case, but most important, to identify opportunities for optimizing the products and for communicating properly the value proposition. This paper also presents schemes for monitoring the results from a business case and for motivating the sales force, as an essential step in increasing the sales. Therefore, alternatives of incentive campaigns are presented, as sustainable campaigns with to purpose to achieve an expected success rate. As an additional support guideline for the sales force, some scenarios and post-sales actions are presented, together with an example of portfolio analysis considering potential per client. Considering the methods and details presented in the current paper, one can identify the importance and find out how to monitor the results after launching a new transactional product addressed to SMEs, can understand and design an incentive scheme and also define actions to be taken in order to increase revenues from a newly launched transactional product.

Considerations for the transition from fuel cell R ampersand D to manufacturing

International Nuclear Information System (INIS)

Cobb, M.A.

1992-01-01

There are a growing number of contractors within the present fuel cell community who have the potential of becoming high volume manufacturers of fuel cell power plants or components. Many are transitioning from basic research operations to manufacturing for the first time. Moving a product from the R ampersand D stage to a viable commercial product depends upon many factors. Some companies are more successful at it than others. We believe there is an underlying transition process from invention to market that is much the same for large, well established firms, as it is for start-ups. How well the process is understood and executed often determines the winners and losers in product commercialization. This paper presents a viewpoint on considerations for transitioning a new technology into commercial production and discusses some affects on organizational development

Ethical considerations in the translation of regenerative biofabrication technologies into clinic and society.

Science.gov (United States)

Otto, I A; Breugem, C C; Malda, J; Bredenoord, A L

2016-10-07

Biofabrication technologies have the potential to improve healthcare by providing highly advanced and personalized biomedical products for research, treatment and prevention. As the combining of emerging techniques and integrating various biological and synthetic components becomes increasingly complex, it is important that relevant stakeholders anticipate the translation of biofabricated 3D tissue products into patients and society. Ethics is sometimes regarded as a brake on scientific progress, yet from our perspective, ethics in parallel with research anticipates societal impacts of emerging technologies and stimulates responsible innovation. For the ethical assessment, the biofabrication field benefits from similarities to regenerative medicine and an increasing ethical awareness in the development of tissue-engineered products. However, the novelty of the technology itself, the increase in attainable structural complexity, and the potential for automation and personalization are distinguishing facets of biofabrication that call for a specific exploration of the ethics of biofabrication. This review aims to highlight important points of existing ethical discussions, as well as to call attention to emerging issues specific to 3D biofabrication in bench and bedside research and the translation to society.

Monitoring additive manufacturing based products in clinical trials

NARCIS (Netherlands)

Marinakis, Yorgos; Harms, Rainer; Walsh, Steven Thomas

2017-01-01

Under U.S. federal regulation 31 CFR §312, medical interventions must report on a series of clinical trials phases before being submitted for approval for release to the U.S. market. Clinical trials are now being performed on medical interventions that were constructed through additive

TRIGA reactor health physics considerations

International Nuclear Information System (INIS)

Johnson, A.G.

1970-01-01

The factors influencing the complexity of a TRIGA health physics program are discussed in details in order to serve as a basis for later consideration of various specific aspects of a typical TRIGA health physics program. The health physics program must be able to provide adequate assistance, control, and safety for individuals ranging from the inexperienced student to the experienced postgraduate researcher. Some of the major aspects discussed are: effluent release and control; reactor area air monitoring; area monitoring; adjacent facilities monitoring; portable instrumentation, personnel monitoring. TRIGA reactors have not been associated with many significant occurrences in the area of health physics, although some operational occurrences have had health physics implications. One specific occurrence at OSU is described involving the detection of non-fission-product radioactive particulates by the continuous air monitor on the reactor top. The studies of this particular situation indicate that most of the particulate activity is coming from the rotating rack and exhausting to the reactor top through the rotating rack loading tube

Biosimilars: Considerations for Oncology Nurses
.

Science.gov (United States)

Vizgirda, Vida; Jacobs, Ira

2017-04-01

Biosimilars are developed to be highly similar to and treat the same conditions as licensed biologics. As they are approved and their use becomes more widespread, oncology nurses should be aware of their development and unique considerations. This article reviews properties of biosimilars; their regulation and approval process; the ways in which their quality, safety, and efficacy are evaluated; their postmarketing safety monitoring; and their significance to oncology nurses and oncology nursing.
. A search of PubMed and regulatory agency websites was conducted for references related to the development and use of biosimilars in oncology. 
. Because biologics are large, structurally complex molecules, biosimilars cannot be considered generic equivalents to licensed biologic products. Consequently, regulatory approval for biosimilars is different from approval for small-molecule generics. Oncology nurses are in a unique position to educate themselves, other clinicians, and patients and their families about biosimilars to ensure accurate understanding, as well as optimal and safe use, of biosimilars.

Primary Healthcare Provider Knowledge, Beliefs and Clinic-Based Practices Regarding Alternative Tobacco Products and Marijuana: A Qualitative Study

Science.gov (United States)

Bascombe, Ta Misha S.; Scott, Kimberly N.; Ballard, Denise; Smith, Samantha A.; Thompson, Winifred; Berg, Carla J.

2016-01-01

Use prevalence of alternative tobacco products and marijuana has increased dramatically. Unfortunately, clinical guidelines have focused on traditional cigarettes with limited attention regarding these emerging public health issues. Thus, it is critical to understand how healthcare professionals view this issue and are responding to it. This…

[Design considerations for clinical data management in an integrated remote medical system].

Science.gov (United States)

Bautu, E; Bautu, A; Ciorap, R; Pomazan, V M; Petcu, L C

2009-01-01

In this paper, we present a proposal for the design of a telemedicine system. The system (called SIMPA) will be used for noninvasive monitoring of some vital parameters of patients with chronic diseases. The telemedicine system contains a fixed unit and some mobile units. The mobile unit contains various sensors used to gather data about vital biosignals, a transceiver and a medical processor. On the fixed unit side, the host transceiver must be compatible with the mobile transceiver. On the server side, an application analyzes and processes the data and further stores it in dedicated databases. The database support for the telemedicine application is ensured by open source technologies and already available communication infrastructures (GSM networks). The requirements for the application were thoroughly analyzed and the Entity-Relationship diagram of the system was designed and translated into relational model. SIMPA will be implemented using only free and open source technologies, which will ensure a low cost and improved extensibility and portability. We presented some design considerations for a low-cost telemedicine system. The system will help optimize medical decisions and will increase the quality of the medical act and lower the cost, to the ultimate benefit of the patient.

First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 5: recipient monitoring and response plan for preventing disease transmission.

Science.gov (United States)

Denner, Joachim; Tönjes, Ralf R; Takeuchi, Yasu; Fishman, Jay; Scobie, Linda

2016-01-01

Xenotransplantation of porcine cells, tissues, and organs may be associated with the transmission of porcine microorganisms to the human recipient. A previous, 2009, version of this consensus statement focused on strategies to prevent transmission of porcine endogenous retroviruses (PERVs). This version addresses potential transmission of all porcine microorganisms including monitoring of the recipient and provides suggested approaches to the monitoring and prevention of disease transmission. Prior analyses assumed that most microorganisms other than the endogenous retroviruses could be eliminated from donor animals under appropriate conditions which have been called "designated pathogen-free" (DPF) source animal production. PERVs integrated as proviruses in the genome of all pigs cannot be eliminated in that manner and represent a unique risk. Certain microorganisms are by nature difficult to eliminate even under DPF conditions; any such clinically relevant microorganisms should be included in pig screening programs. With the use of porcine islets in clinical trials, special consideration has to be given to the presence of microorganisms in the isolated islet tissue to be used and also to the potential use of encapsulation. It is proposed that microorganisms absent in the donor animals by sensitive microbiological examination do not need to be monitored in the transplant recipient; this will reduce costs and screening requirements. Valid detection assays for donor and manufacturing-derived microorganisms must be established. Special consideration is needed to preempt potential unknown pathogens which may pose a risk to the recipient. This statement summarizes the main achievements in the field since 2009 and focus on issues and solutions with microorganisms other than PERV. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Consideration about chemistry, manufacture and control (CMC) key problems in simplified registration of classical traditional Chinese medicine excellent prescriptions].

Science.gov (United States)

Wang, Zhi-Min; Liu, Ju-Yan; Liu, Xiao-Qian; Wang, De-Qin; Yan, Li-Hua; Zhu, Jin-Jin; Gao, Hui-Min; Li, Chun; Wang, Jin-Yu; Li, Chu-Yuan; Ni, Qing-Chun; Huang, Ji-Sheng; Lin, Juan

2017-05-01

As an outstanding representative of traditional Chinese medicine(TCM) prescriptions accumulated from famous TCM doctors' clinical experiences in past dynasties, classical TCM excellent prescriptions (cTCMeP) are the most valuable part of TCM system. To support the research and development of cTCMeP, a series of regulations and measures were issued to encourage its simplified registration. There is still a long-way to go because many key problems and puzzles about technology, registration and administration in cTCMeP R&D process are not resolved. Based on the analysis of registration and management regulations of botanical drug products in FDA of USA and Japan, and EMA of Europe, the possible key problems and countermeasures in chemistry, manufacture and control (CMC) of simplified registration of cTCMeP were analyzed on the consideration of its actual situation. The method of "reference decoction extract by traditional prescription" (RDETP) was firstly proposed as standard to evaluate the quality and preparation uniformity between the new developing product under simplified registration and traditional original usages of cTCMeP, instead of Standard Decoction method in Japan. "Totality of the evidence" approach, mass balance and bioassay/biological assay of cTCMeP were emphatically suggested to introduce to the quality uniformity evaluation system in the raw drug material, drug substance and final product between the modern product and traditional decoction. Copyright© by the Chinese Pharmaceutical Association.

Materials considerations in accelerator targets

International Nuclear Information System (INIS)

Peacock, H. B. Jr.; Iyer, N. C.; Louthan, M. R. Jr.

1995-01-01

Future nuclear materials production and/or the burn-up of long lived radioisotopes may be accomplished through the capture of spallation produced neutrons in accelerators. Aluminum clad-lead and/or lead alloys has been proposed as a spallation target. Aluminum was the cladding choice because of the low neutron absorption cross section, fast radioactivity decay, high thermal conductivity, and excellent fabricability. Metallic lead and lead oxide powders were considered for the target core with the fabrication options being casting or powder metallurgy (PM). Scoping tests to evaluate gravity casting, squeeze casting, and casting and swaging processes showed that, based on fabricability and heat transfer considerations, squeeze casting was the preferred option for manufacture of targets with initial core cladding contact. Thousands of aluminum clad aluminum-lithium alloy core targets and control rods for tritium production have been fabricated by coextrusion processes and successfully irradiated in the SRS reactors. Tritium retention in, and release from, the coextruded product was modeled from experimental and operational data. The model assumed that tritium atoms, formed by the 6Li(n,a)3He reaction, were produced in solid solution in the Al-Li alloy. Because of the low solubility of hydrogen isotopes in aluminum alloys, the irradiated Al-Li rapidly became supersaturated in tritium. Newly produced tritium atoms were trapped by lithium atoms to form a lithium tritide. The effective tritium pressure required for trap or tritide stability was the equilibrium decomposition pressure of tritium over a lithium tritide-aluminum mixture. The temperature dependence of tritium release was determined by the permeability of the cladding to tritium and the local equilibrium at the trap sites. The model can be used to calculate tritium release from aluminum clad, aluminum-lithium alloy targets during postulated accelerator operational and accident conditions. This paper describes

Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers.

Science.gov (United States)

Yoshita, Tomohiro; Uchida, Shinya; Namiki, Noriyuki

2013-01-01

Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=9-10; age range, 21-28 years). A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. The clinical disintegration time of the 17 ODT products was between 17.6 s and 33.8 s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40 s and 30.4 s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; pdisintegration and that the disintegration time varied according to the product. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity.

Modeling food logistics networks with emission considerations: the case of an international beef supply chain

NARCIS (Netherlands)

Soysal, M.; Bloemhof, J.M.; Vorst, van der J.G.A.J.

2014-01-01

Intrinsic characteristics of food products and processes along with growing sustainability concerns lead to the need for decision support tools that can integrate economic considerations with quality preservation and environmental protection in food supply chains. In this study, we develop a

49 CFR 260.7 - Priority consideration.

Science.gov (United States)

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Priority consideration. 260.7 Section 260.7... REHABILITATION AND IMPROVEMENT FINANCING PROGRAM Overview § 260.7 Priority consideration. When evaluating applications, the Administrator will give priority consideration (but not necessarily in the following order...

Flowable Resin Composites: A Systematic Review and Clinical Considerations

Science.gov (United States)

Rodrigues, Jean C.

2015-01-01

Background Little is known about flowable composite materials. Most literature mentions conventional composite materials at large, giving minimal emphasis to flowables in particular. This paper briefly gives an in depth insight to the multiple facets of this versatile material. Aim To exclusively review the most salient features of flowable composite materials in comparison to conventional composites and to give clinicians a detailed understanding of the advantages, drawbacks, indications and contraindications based on composition and physical/mechanical properties. Methodology Data Sources: A thorough literature search from the year 1996 up to January 2015 was done on PubMed Central, The Cochrane Library, Science Direct, Wiley Online Library, and Google Scholar. Grey literature (pending patents, technical reports etc.) was also screened. The search terms used were “dental flowable resin composites”. Search Strategy After omitting the duplicates/repetitions, a total of 491 full text articles were assessed. As including all articles were out of the scope of this paper. Only relevant articles that fulfilled the reviewer’s objectives {mentioning indications, contraindications, applications, assessment of physical/mechanical/biological properties (in vitro/ in vivo /ex vivo)} were considered. A total of 92 full text articles were selected. Conclusion Flowable composites exhibit a variable composition and consequently variable mechanical/ physical properties. Clinicians must be aware of this aspect to make a proper material selection based on specific properties and indications of each material relevant to a particular clinical situation. PMID:26266238

Environmental policy considerations and renewable energy in Bangladesh

International Nuclear Information System (INIS)

Sarkar, M.A.R.; Obaidullah, M.

2000-01-01

Energy is a critical commodity. It functions as a factor of production, as a process feedstock and as a consumer goods. It determines the shape of the life of individuals and that of the total economy. The evidence all over the world has shown a positive association between per capita income and per capita consumption. In fact over the world has consumption is now regarded as one of the important indices of economic development. Economic development is seen to have been accompanied by substitution of one form of energy by another As an economy develops, its demand for energy tends to increase and its consumption pattern in terms of energy forms and energy sources tends changes. But the stock of known viable sources of energy particularly commercial fuels are exploitation of energy sources involves a large investment and long gestation period. These and other related considerations emphases the need for taking a long-run view on demand and supply aspects of energy with particular focus on renewable energy. This further requires necessary policy considerations, which should be favorable for long term and sustained development of renewable energy. (Author)

Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

Science.gov (United States)

Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

2011-06-01

To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

Considerations Concerning the Application of Target Costing Method in the Industry of Dairy Products

Directory of Open Access Journals (Sweden)

Mortură Laura Alexandra

2017-01-01

Full Text Available In the present conditions of the market economy, which is in full process of globalization, theadaptation of the more complex and diverse needs of the final consumers, leads to a permanentcreation and development of new products and services by the entities in order to satisfy theseneeds. Thus, the entities must apply efficient and tested methods for determining and provisioningthe costs which will result from launching new products on the market, methods which wouldsupport and ensure the best quality – price report, and which are to reduce the production costs upto a level of not affecting the quality of the final product. Such a method, according to specialtyliterature is the modern method of Target Costing.

46 CFR 175.550 - Special consideration.

Science.gov (United States)

2010-10-01

... 46 Shipping 7 2010-10-01 2010-10-01 false Special consideration. 175.550 Section 175.550 Shipping...) GENERAL PROVISIONS § 175.550 Special consideration. In applying the provisions of this subchapter, the OCMI may give special consideration to authorizing departures from the specific requirements when...

Hypochondriasis: considerations for ICD-11

Directory of Open Access Journals (Sweden)

Odile A. van den Heuvel

2014-01-01

Full Text Available The World Health Organization (WHO is currently revisiting the ICD. In the 10th version of the ICD, approved in 1990, hypochondriacal symptoms are described in the context of both the primary condition hypochondriacal disorder and as secondary symptoms within a range of other mental disorders. Expansion of the research base since 1990 makes a critical evaluation and revision of both the definition and classification of hypochondriacal disorder timely. This article addresses the considerations reviewed by members of the WHO ICD-11 Working Group on the Classification of Obsessive-Compulsive and Related Disorders in their proposal for the description and classification of hypochondriasis. The proposed revision emphasizes the phenomenological overlap with both anxiety disorders (e.g., fear, hypervigilance to bodily symptoms, and avoidance and obsessive-compulsive and related disorders (e.g., preoccupation and repetitive behaviors and the distinction from the somatoform disorders (presence of somatic symptom is not a critical characteristic. This revision aims to improve clinical utility by enabling better recognition and treatment of patients with hypochondriasis within the broad range of global health care settings.

Consideration Sets and Their Role in Modelling Doctor Recommendations About Contraceptives.

Science.gov (United States)

Fiebig, Denzil G; Viney, Rosalie; Knox, Stephanie; Haas, Marion; Street, Deborah J; Hole, Arne R; Weisberg, Edith; Bateson, Deborah

2017-01-01

Decisions about prescribed contraception are typically the result of a consultation between a woman and her doctor. In order to better understand contraceptive choice within this environment, stated preference methods are utilized to ask doctors about what contraceptive options they would discuss with different types of women. The role of doctors is to confine their discussion to a subset of products that best match their patient. This subset of options forms the consideration set from which the ultimate recommendation is made. Given the existence of consideration sets we address the issue of how to model appropriately the ultimate recommendations. The estimated models enable us to characterize doctor recommendations and how they vary with patient attributes and to highlight where recommendations are clear and when they are uncertain. The results also indicate systematic variation in recommendations across different types of doctors, and in particular we observe that some doctors are reluctant to embrace new products and instead recommend those that are more familiar. Such effects are one possible explanation for the relatively low uptake of more cost effective longer acting reversible contraceptives and indicate that further education and training of doctors may be warranted. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Axis I diagnoses and transition to psychosis in clinical high-risk patients EPOS project: Prospective follow-up of 245 clinical high-risk outpatients in four countries

NARCIS (Netherlands)

Salokangas, Raimo K. R.; Ruhrmann, Stephan; von Reventlow, Heinrich Graf; Heinimaa, Markus; Svirskis, Tanja; From, Tiina; Luutonen, Sinikka; Juckel, Georg; Linszen, Don; Dingemans, Peter; Birchwood, Max; Patterson, Paul; Schultze-Lutter, Frauke; Klosterkötter, Joachim; Picke, Heinz; Neumann, Meike; Brockhaus-Dumke, Anke; Pukrop, Ralf; Huttunen, Jukka; Laine, Tiina; Ilonen, Tuula; Ristkari, Terja; Hietala, Jarmo; Becker, Hiske; Nieman, Dorien; Skeate, Amanda; Gudlowski, Yehonala; Ozgürdal, Seza; Witthaus, Henning; French, Paul; Stevens, Helen

2012-01-01

Background: In selected samples, a considerable number of patients at clinical high risk of psychosis (CHR) are found to meet criteria for co-morbid clinical psychiatric disorders. It is not known how clinical diagnoses correspond to or even predict transitions to psychosis (TTP). Our aim was to

Aligning Animal Models of Clinical Germinal Matrix Hemorrhage, From Basic Correlation to Therapeutic Approach.

Science.gov (United States)

Lekic, Tim; Klebe, Damon; Pichon, Pilar; Brankov, Katarina; Sultan, Sally; McBride, Devin; Casel, Darlene; Al-Bayati, Alhamza; Ding, Yan; Tang, Jiping; Zhang, John H

2017-01-01

Germinal matrix hemorrhage is a leading cause of mortality and morbidity from prematurity. This brain region is vulnerable to bleeding and re-bleeding within the first 72 hours of preterm life. Cerebroventricular expansion of blood products contributes to the mechanisms of brain injury. Consequences include lifelong hydrocephalus, cerebral palsy, and intellectual disability. Unfortunately little is known about the therapeutic needs of this patient population. This review discusses the mechanisms of germinal matrix hemorrhage, the animal models utilized, and the potential therapeutic targets. Potential therapeutic approaches identified in pre-clinical investigations include corticosteroid therapy, iron chelator administration, and transforming growth factor-β pathway modulation, which all warrant further investigation. Thus, effective preclinical modeling is essential for elucidating and evaluating novel therapeutic approaches, ahead of clinical consideration. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Clinical and morphological considerations in one case with cervical cancer and right ureterohydronephrosis.

Science.gov (United States)

Ghib Para, Cristina Georgiana; Sferdian, Mircea Florin; Daşcău, Voicu; Păiuşan, Lucian; Ioiart, Ioan

2016-01-01

We present the case of a 34-year-old female with cervical cancer and right ureterohydronephrosis. She was admitted to the Urology Clinic of the Emergency County Hospital of Arad, Romania, on November 11, 2015, after previously being diagnosed with stage IIIA cervical cancer in December 2014 and undergoing radio and chemotherapy and laparotomy for staging. At the moment of hospital admission, the patient suffered from fever and right lumbar pain, she was also diagnosed with grade IV right ureterohydronephrosis. The patient was operated at the Urology Clinic of Arad; the intervention involved a total hysterectomy with bilateral adnexectomy and a right obturatory necrectomy of the necrotic lymph nodes. However, the evolution was favorable. The purpose was to increase the patient's survival rate and increase the quality of her life by also applying one palliative method including a urethral stent. As a result, the patient's life was extended.

Fundamentals of clinical trials

CERN Document Server

Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

2015-01-01

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

15 CFR 2301.5 - Special consideration.

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2010-01-01

... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Special consideration. 2301.5 Section... PROGRAM Application Requirements § 2301.5 Special consideration. In accordance with section 392(f) of the Act, the Agency will give special consideration to applications that foster ownership of, operation of...

46 CFR 169.112 - Special consideration.

Science.gov (United States)

2010-10-01

... 46 Shipping 7 2010-10-01 2010-10-01 false Special consideration. 169.112 Section 169.112 Shipping... Provisions § 169.112 Special consideration. In applying the provisions of this part, the Officer in Charge, Marine Inspection, may give special consideration to departures from the specific requirements when...

How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study.

Science.gov (United States)

Berger, M; Kooyman, P J; Makkee, M; van der Zee, J S; Sterk, P J; van Dijk, J; Kemper, E M

2016-08-19

Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the study. However, there are no specific regulations or guidelines for non-Medicinal Investigational Products (non-MIPs) such as allergens, enriched food supplements, and air pollution components. As a consequence, investigators will avoid clinical research and prefer preclinical models or in vitro testing for e.g. toxicology studies. 1) briefly review the current guidelines and regulations for Investigational Medicinal Products; 2) present a standardised approach to ensure the quality and safety of non-MIPs in human in vivo research; and 3) discuss some lessons we have learned. We propose a practical line of approach to compose a clarifying product dossier (PD), comprising the description of the production process, the analysis of the raw and final product, toxicological studies, and a thorough risk-benefit-analysis. This is illustrated by an example from a human in vivo research model to study exposure to air pollutants, by challenging volunteers with a suspension of carbon nanoparticles (the component of ink cartridges for laser printers). With this novel risk-based approach, the members of competent authorities are provided with standardised information on the quality of the product in relation to the safety of the participants, and the scientific goal of the study.

Biosimilars in the United States: Considerations for Oncology Advanced Practitioners.

Science.gov (United States)

Mayden, Kelley D; Larson, Paul; Geiger, Danielle; Watson, Holly

2015-01-01

Biosimilars will enter the US market soon, potentially lowering costs and increasing patient access to important oncology biologics. Biosimilars are highly similar, but not identical, to their reference product. Subtle variations arise due to their inherent complexity and differences in manufacturing. Biosimilars are not generic drugs. They will be approved through a separate US regulatory pathway-distinct from conventional biologics license applications-based on analytic and clinical studies demonstrating no clinically meaningful differences from the reference product. As policies on US biosimilars evolve, it is important that advanced practitioners receive comprehensive, ongoing education on them, particularly regarding differences from small-molecule drugs; their approval pathways vs. conventional regulatory pathways; evaluation of quality, safety, and efficacy; safety monitoring; and product identification to facilitate accurate safety reporting. Advanced practitioners will play a key role in educating nurses and patients on biosimilars. Nurse education should highlight any differences from the reference product (e.g., approved indications and delivery devices) and should emphasize assessment of substitutions, monitoring for adverse events (e.g., immune reactions), and the need for precise documentation for safety reports. Patient education should address differences between the biosimilar and reference product in administration, handling and storage, and self-monitoring for adverse events.