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Sample records for products clinical considerations

  1. Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics.

    Science.gov (United States)

    Li, Zhaoyang; Easton, Rachael

    2018-01-01

    The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field.

  2. Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics

    Science.gov (United States)

    Easton, Rachael

    2018-01-01

    ABSTRACT The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field. PMID:29035675

  3. Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

    Science.gov (United States)

    Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

    2018-01-08

    The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

  4. Local anesthesia in dentistry - Clinical Considerations

    OpenAIRE

    Sharmraaj Subramaniam; Prasanna Neelakantan

    2013-01-01

    Local anaesthesia is commonly employed prior to most dental procedures. It is imperative to understand the mechanisms by which local anaesthetics work, so that their efficacy can be improved for painless dental care. Local anaesthesia also has major clinical implications in that it can precipitate emergencies in patients with an underlying systemic disease. It is imperative that a dentist have a thorough knowledge of the considerations one must take when administering local anaesthesia in pat...

  5. Marfan Syndrome: Clinical, Surgical, and Anesthetic Considerations.

    Science.gov (United States)

    Castellano, José M; Silvay, George; Castillo, Javier G

    2014-09-01

    Marfan syndrome is a multisystem connective tissue disorder, with primary involvement of the cardiovascular, ocular, and skeletal systems. This autosomal heritable disease is mainly attributable to a defect in the FBN1 gene. Clinical diagnosis of Marfan syndrome has been based on the Ghent criteria since 1996. In 2010, these criteria were updated, and the revised guidelines place more emphasis on aortic root dilation, ectopia lentis, and FBN1 mutation testing in the diagnostic assessment of Marfan syndrome. Among its many different clinical manifestations, cardiovascular involvement deserves special consideration, owing to its impact on prognosis. Recent molecular, surgical, and clinical research has yielded profound new insights into the pathological mechanisms that ultimately lead to tissue degradation and weakening of the aortic wall, which has led to exciting new treatment strategies. Furthermore, with the increasing life expectancy of patients with Marfan syndrome, there has been a subtle shift in the spectrum of medical problems. Consequently, this article focuses on recent advances to highlight their potential impact on future concepts of patient care from a clinical, surgical, and anesthetic perspective. © The Author(s) 2013.

  6. Development Considerations for Nanocrystal Drug Products.

    Science.gov (United States)

    Chen, Mei-Ling; John, Mathew; Lee, Sau L; Tyner, Katherine M

    2017-05-01

    Nanocrystal technology has emerged as a valuable tool for facilitating the delivery of poorly water-soluble active pharmaceutical ingredients (APIs) and enhancing API bioavailability. To date, the US Food and Drug Administration (FDA) has received over 80 applications for drug products containing nanocrystals. These products can be delivered by different routes of administration and are used in a variety of therapeutic areas. To aid in identifying key developmental considerations for these products, a retrospective analysis was performed on the submissions received by the FDA to date. Over 60% of the submissions were for the oral route of administration. Based on the Biopharmaceutics Classification System (BCS), most nanocrystal drugs submitted to the FDA are class II compounds that possess low aqueous solubility and high intestinal permeability. Impact of food on drug bioavailability was reduced for most nanocrystal formulations as compared with their micronized counterparts. For all routes of administration, dose proportionality was observed for some, but not all, nanocrystal products. Particular emphasis in the development of nanocrystal products was placed on the in-process tests and controls at critical manufacturing steps (such as milling process), mitigation and control of process-related impurities, and the stability of APIs or polymorphic form (s) during manufacturing and upon storage. This emphasis resulted in identifying challenges to the development of these products including accurate determination of particle size (distribution) of drug substance and/or nanocrystal colloidal dispersion, identification of polymorphic form (s), and establishment of drug substance/product specifications.

  7. Emollient treatment of atopic dermatitis: latest evidence and clinical considerations

    Directory of Open Access Journals (Sweden)

    Kam Lun Hon

    2018-04-01

    Full Text Available Aim: To review current classes of emollients in the market, their clinical efficacy in atopic dermatitis (AD and considerations for choice of an emollient. Methods: PubMed Clinical Queries under Clinical Study Categories (with Category limited to Therapy and Scope limited to Narrow and Systematic Reviews were used as the search engine. Keywords of ‘emollient or moisturizer’ and ‘atopic dermatitis’ were used. Overview of findings: Using the keywords of ‘emollient’ and ‘atopic dermatitis’, there were 105 and 36 hits under Clinical Study Categories (with Category limited to Therapy and Scope limited to Narrow and Systematic Reviews, respectively. Plant-derived products, animal products and special ingredients were discussed. Selected proprietary products were tabulated. Conclusions: A number of proprietary emollients have undergone trials with clinical data available on PubMed-indexed journals. Most moisturizers showed some beneficial effects, but there was generally no evidence that one moisturizer is superior to another. Choosing an appropriate emollient for AD patients would improve acceptability and adherence for emollient treatment. Physician’s recommendation is the primary consideration for patients when selecting a moisturizer/ emollient; therefore, doctors should provide evidence-based information about these emollients.

  8. [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

  9. 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.

  10. Clinical and financial considerations for implementing an ICU telemedicine program.

    Science.gov (United States)

    Kruklitis, Robert J; Tracy, Joseph A; McCambridge, Matthew M

    2014-06-01

    As the population in the United States increases and ages, the need to provide high-quality, safe, and cost-effective care to the most critically ill patients will be of great importance. With the projected shortage of intensivists, innovative changes to improve efficiency and increase productivity will be necessary. Telemedicine programs in the ICUs (tele-ICUs) are a successful strategy to improve intensivist access to critically ill patients. Although significant capital and maintenance costs are associated with tele-ICUs, these costs can be offset by indirect financial benefits, such as decreased length of stay. To achieve the positive clinical outcomes desired, tele-ICUs must be carefully designed and implemented. In this article, we discuss the clinical benefits of tele-ICUs. We review the financial considerations, including direct and indirect reimbursement and development and maintenance costs. Finally, we review design and implementation considerations for tele-ICUs.

  11. 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…

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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

  17. Smallpox: clinical highlights and considerations for vaccination.

    Directory of Open Access Journals (Sweden)

    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.

  18. 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.

  19. 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

  20. 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)

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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.

  7. 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...

  8. Design control considerations for biologic-device combination products.

    Science.gov (United States)

    Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

    2017-03-01

    Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting

  9. 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....

  10. Practical Considerations for Clinical PET/MR Imaging.

    Science.gov (United States)

    Galgano, Samuel; Viets, Zachary; Fowler, Kathryn; Gore, Lael; Thomas, John V; McNamara, Michelle; McConathy, Jonathan

    2018-01-01

    Clinical PET/MR imaging is currently performed at a number of centers around the world as part of routine standard of care. This article focuses on issues and considerations for a clinical PET/MR imaging program, focusing on routine standard-of-care studies. Although local factors influence how clinical PET/MR imaging is implemented, the approaches and considerations described here intend to apply to most clinical programs. PET/MR imaging provides many more options than PET/computed tomography with diagnostic advantages for certain clinical applications but with added complexity. A recurring theme is matching the PET/MR imaging protocol to the clinical application to balance diagnostic accuracy with efficiency. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. 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.

  12. Optimizing clinical drug product performance

    DEFF Research Database (Denmark)

    Dickinson, Paul A.; Kesisoglou, Filippos; Flanagan, Talia

    2016-01-01

    The aim of Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid is to facilitate optimization of clinical performance of drug products. BioRAM strategy relies on therapy-driven drug delivery and follows an integrated systems approach for formulating and addressing critical...... questions and decision-making (J Pharm Sci. 2014,103(11): 3777-97). In BioRAM, risk is defined as not achieving the intended in vivo drug product performance, and success is assessed by time to decision-making and action. Emphasis on time to decision-making and time to action highlights the value of well....... Application of the BioRAM Scoring Grid is illustrated using published literature. Organizational considerations for implementing BioRAM strategy, including the interactions, function, and skillsets of the BioRAM group members, are also reviewed. As a creative and innovative systems approach, we believe...

  13. Considerations for Clinical Neuropsychological Evaluation in Amyotrophic Lateral Sclerosis.

    Science.gov (United States)

    Woolley, Susan C; Rush, Beth K

    2017-11-01

    The clinical neuropsychologist has the opportunity to be uniquely involved in the evaluation and treatment of individuals with amyotrophic lateral sclerosis (ALS). We review the current literature that defines cognitive and behavioral symptoms in ALS, including current knowledge of the neuropathological and genetic underpinning for these symptoms. There are unique considerations for clinical neuropsychological evaluation and clinical research in ALS and we highlight these in this review. Specifically, we shed light on special factors that contribute to our understanding of cognitive and behavioral impairment in ALS, including co-morbid symptoms, differential diagnosis, and considerations for longitudinal tracking of phenotypes. We discuss the rationale for proposing a specific approach to such as cognitive screening, test selection, response modality consideration, and test-retest intervals. With this didactic overview, the clinical neuropsychologist has the potential to learn more about the heterogeneous presentation of motor and neuropsychological symptoms in ALS. Furthermore, the reader has the opportunity to understand what it takes to develop a valid assessment approach particularly when the phenotype of ALS remains undefined in some regards. This clinical practice review sets the stage for the clinical neuropsychologist to further contribute to our clinical and scientific understanding of ALS and cognition. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  14. 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...

  15. Cyanobacteria and Microalgae: Thermoeconomic Considerations in Biofuel Production

    Directory of Open Access Journals (Sweden)

    Umberto Lucia

    2018-01-01

    Full Text Available In thermodynamics, the useful work in any process can be evaluated by using the exergy quantity. The analyses of irreversibility are fundamental in the engineering design and in the productive processes’ development in order to obtain the economic growth. Recently, the use has been improved also in the thermodynamic analysis of the socio-economic context. Consequently, the exergy lost is linked to the energy cost required to maintain the productive processes themselves. The fundamental role of the fluxes and the interaction between systems and their environment is highlighted. The equivalent wasted primary resource value for the work-hour is proposed as an indicator to support the economic considerations on the biofuel production by using biomass and bacteria. The equivalent wasted primary resource value for the work-hour is proposed as an indicator to support the economic considerations of the biofuel production by using biomass and bacteria. Moreover, the technological considerations can be developed by using the exergy inefficiency. Consequently, bacteria use can be compared with other means of biofuel production, taking into account both the technologies and the economic considerations. Cyanobacteria results as the better organism for biofuel production.

  16. Design considerations for the commercial production of wood acrylics

    International Nuclear Information System (INIS)

    Witt, A.E.; Bosco, L.R.

    1978-01-01

    The major application of wood acrylics is for flooring, more specifically in high traffic area. The most important property is its abrasion resistance. As for the decisions in facility design, the following considerations must be made: irradiation or heat-catalyst to polymerize, machine irradiation or isotope irradiation, and wet or dry irradiation. Then, processing considerations are made on wood type, monomer selection, dye selection, fire retardant, dose conditions and crosslinker usage. In ''PermaGrain'' production, for example, the facility has the yearly production capacity of over 4,000,000 kilograms of wood acrylic. The starting wood form is small slats or fingers. After pressure cycle, the impregnant wet wood is lowered into an irradiation pool and the product canister passes around a cobalt 60 source. After irradiation, the product is taken out of the pool and allowed to cool. Then, final sizing and finishing are carried out. (Mori, K.)

  17. 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.

  18. [Innovative Prenatal Testing: Clinical Applications and Ethical Considerations].

    Science.gov (United States)

    Huang, Mei-Chih; Lin, Shio-Jean; Chen, Chih-Ling; Huang, Tzu-Jung

    2017-10-01

    The biomedical technology related to prenatal screen/diagnosis has developed rapidly in recent decades. Many prenatal genetic examinations are now available to assist pregnant women to better understand the status and development of their fetus. Moreover, many commercial advertisements for innovative prenatal examinations are now shown in the media. Cell-free DNA Screening (cfDNA screening), a non-invasive prenatal testing (NIPT) procedure, is a safe and high accuracy test that may be done at an earlier gestational age to screen for fetal aneuploidy. The following questions should be considered when applying cfDNA screening in clinical practice: 1. what is cfDNA screening, 2. who are its potential users, and 3. what ethical and policy considerations are associated with this examination? This article provides relevant information, clinical practice guidelines, and ethical / policy considerations related to cfDNA screening. Discussing cases involving different clinical situations helps promote understanding of cfDNA screening and maternal-care quality.

  19. 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.

  20. Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

    Science.gov (United States)

    Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

    2016-11-01

    This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

  1. 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.

  2. 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.

  3. 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.

  4. 78 FR 15009 - Consideration of Withdrawal From Commercial Production and Distribution of the Radioisotope...

    Science.gov (United States)

    2013-03-08

    ... DEPARTMENT OF ENERGY Consideration of Withdrawal From Commercial Production and Distribution of... its consideration of DOE withdrawal from the commercial production and distribution of germanium-68... Statement of Policy, referenced above. In summary, DOE's evaluation will include consideration of: a...

  5. 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.

  6. Considerations of critical quality attributes in the analytical comparability assessment of biosimilar products.

    Science.gov (United States)

    Kwon, Ohseok; Joung, Jeewon; Park, Younjoo; Kim, Chan Wha; Hong, Seung Hwa

    2017-07-01

    Based on experience in clinical trial approvals and marketing authorizations for biosimilar products in Korea, we suggest principles for the analytical comparability assessment of biosimilar products with respect to regulatory considerations. The composition and manufacturing processes of biosimilar products can differ from those of the reference product depending on the information available for the reference product and the time of product development; however, the analytical characteristics of biosimilar products should be highly similar to those of the reference product. Although manufacturing an identical product in terms of the quality profile is nearly impossible due to the high molecular weight and complex structure of biological products, the developer of the biosimilar product should attempt to establish a quality level as similar to that of the reference product as possible. When comparing the similarity of quality attributes, the criticality of the quality attributes and the characteristics of orthogonal quality attributes need to be considered carefully. Based on the results from the analytical comparability assessment, the comparability results of non-clinical and clinical studies should be evaluated before claiming biosimilarity to the reference product. In this review, we focus on quality attribute evaluation based on our regulatory experience. Copyright © 2017 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  7. 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.

  8. 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.

  9. 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.

  10. [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.

  11. Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

    Science.gov (United States)

    Kudrin, Alex; Knezevic, Ivana; Joung, Jeewon; Kang, Hye-Na

    2015-01-01

    The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia. The following topics were discussed by the working groups: clinical criteria for biosimilarity, extrapolation approach and the overall regulatory decision making process. In order to determine typical pitfalls in the design of a SBP clinical programme and evaluate the gap of knowledge, amongst different industry and regulatory stakeholders on the appraisal of the data arising from SBP clinical studies, we have presented two fictional but realistic clinical case studies. The first case consists of the fictional development programme for an infliximab SBP candidate. The second case describes clinical studies proposed for a fictional rituximab SBP candidate. In the first scenario a highly similar quality profile has been taken forward into clinical studies whereas there was an important residual difference in functional attributes for the rituximab SBP candidate. These case studies were presented at the WHO implementation workshop for the WHO guidelines on evaluation of similar biotherapeutic products held in Seoul, Republic of Korea, in May 2014. The goal was to illustrate the interpretation of the clinical data arising from studies with SBP candidates and elicit knowledge gaps in clinical assessment. This paper reflects the outcome of the exercise and discussions held in Seoul and offers an analysis of the case studies as a learning opportunity on clinical development and evaluation of SBPs. Copyright © 2014 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  12. 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...

  13. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    Science.gov (United States)

    Pierre, Christine

    2008-01-01

    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  14. 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,…

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. Endo-perio lesions: Diagnosis and clinical considerations

    Directory of Open Access Journals (Sweden)

    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.

  20. 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 ...

  1. 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

  2. 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

  3. 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.

  4. 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...

  5. 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.

  6. 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

  7. 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.

  8. Sleep Health Issues for Children with FASD: Clinical Considerations

    Directory of Open Access Journals (Sweden)

    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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. 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

  16. Clinical utility of metabolic syndrome severity scores: considerations for practitioners

    Directory of Open Access Journals (Sweden)

    DeBoer MD

    2017-02-01

    Full Text Available Mark D DeBoer,1,2 Matthew J Gurka2 11Division of Pediatric Endocrinology, Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, 2Department of Health Outcomes and Policy, College of Medicine, University of Florida, Gainesville, FL, USA Abstract: The metabolic syndrome (MetS is marked by abnormalities in central obesity, high blood pressure, high triglycerides, low high-density lipoprotein-cholesterol, and high fasting glucose and appears to be produced by underlying processes of inflammation, oxidative stress, and adipocyte dysfunction. MetS has traditionally been classified based on dichotomous criteria that deny that MetS-related risk likely exists as a spectrum. Continuous MetS scores provide a way to track MetS-related risk over time. We generated MetS severity scores that are sex- and race/ethnicity-specific, acknowledging that the way MetS is manifested may be different by sex and racial/ethnic subgroup. These scores are correlated with long-term risk for type 2 diabetes mellitus and cardiovascular disease. Clinical use of scores like these provide a potential opportunity to identify patients at highest risk, motivate patients toward lifestyle change, and follow treatment progress over time. Keywords: metabolic syndrome, insulin resistance, cardiovascular disease, type 2 diabetes, risk prediction

  17. 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.

  18. Human factors consideration in clinical applications of virtual reality.

    Science.gov (United States)

    Lewis, C H; Griffin, M J

    1997-01-01

    Virtual reality environments have many potential applications in medicine, including surgical training, tele-operated robotic surgery, assessment and rehabilitation of behavioural and neurological disorders and diagnosis, therapy and rehabilitation of physical disabilities. Although there is much potential for the use of immersive virtual reality environments in clinical applications, there are problems which could limit their ultimate usability. Some users have experienced side-effects during and after exposure to virtual reality environments. The symptoms include ocular problems, disorientation and balance disturbances, and nausea. Susceptibility to side-effects can be affected by age, ethnicity, experience, gender and physical fitness, as well as the characteristics of the display, the virtual environment and the tasks. The characteristics of the virtual reality system have also been shown to affect the ability of users to perform tasks in a virtual environment. Many of these effects can be attributed to delays between the sampling of head and limb positions and the presentation of an appropriate image on the display. The introduction of patients to virtual reality environments, for assessment, therapy or rehabilitation, raises particular safety and ethical issues. Patients exposed to virtual reality environments for assessment and rehabilitation may have disabilities which increase their susceptibility to certain side-effects. Special precautions therefore need to be taken to ensure the safety and effectiveness of such virtual reality applications. These precautions include minimisation of possible side-effects at the design stage. Factors are identified which are likely to affect the incidence of side-effects during and after exposures, and which need to be understood in order to minimise undesirable consequences. There is also a need for the establishment of protocols for monitoring and controlling exposures of patients to virtual reality environments. Issues

  19. Clinical Considerations of Preimplantation Genetic Diagnosis for Monogenic Diseases.

    Directory of Open Access Journals (Sweden)

    Xiaokun Hu

    Full Text Available The aim of this study was to explore factors contribute to the success of PGD cycles for monogenic diseases.During a 3-year period (January 2009 to December 2012, 184 consecutive ICSI-PGD cycles for monogenic diseases reaching the ovum pick-up and fresh embryo-transfer stage performed at the Reproductive Medicine Center of The First Affiliated Hospital Of Sun Yat-sen University were evaluated.ICSI was performed on 2206 metaphase II oocytes, and normal fertilization and cleavage rates were 83.4% (1840/2206 and 96.2% (1770/1840, respectively. In the present study, 60.5% (181/299 of day 3 good-quality embryos developed into good-quality embryos on day 4 after biopsy. Collectively, 42.9% clinical pregnancy rate (79/184 and 28.5% implantation rate (111/389 were presented. In the adjusted linear regression model, the only two significant factors affecting the number of genetically unaffected embryos were the number of biopsied embryos (coefficient: 0.390, 95%CI 0.317-0.463, P = 0.000 and basal FSH level (coefficient: 0.198, 95%CI 0.031-0.365, P = 0.021. In the adjusted binary logistic regression model, the only two significant factors affecting pregnancy outcome were the number of genetically available transferable embryos after PGD (adjusted OR 1.345, 95% CI 1.148-1.575, P = 0.000 and number of oocyte retrieved (adjusted OR 0.934, 95% CI 0.877-0.994, P = 0.031.There should be at least four biopsied embryos to obtain at least one unaffected embryos in a PGD system for patients with single gene disorder and under the condition of basal FSH level smaller than 8.0mmol/L. Moreover, if only a low number (< 4 of biopsied embryos are available on day 3, the chance of unaffected embryos for transfer was small, with poor outcome.

  20. The thoracolumbar fascia: anatomy, function and clinical considerations

    Science.gov (United States)

    Willard, F H; Vleeming, A; Schuenke, M D; Danneels, L; Schleip, R

    2012-01-01

    In this overview, new and existent material on the organization and composition of the thoracolumbar fascia (TLF) will be evaluated in respect to its anatomy, innervation biomechanics and clinical relevance. The integration of the passive connective tissues of the TLF and active muscular structures surrounding this structure are discussed, and the relevance of their mutual interactions in relation to low back and pelvic pain reviewed. The TLF is a girdling structure consisting of several aponeurotic and fascial layers that separates the paraspinal muscles from the muscles of the posterior abdominal wall. The superficial lamina of the posterior layer of the TLF (PLF) is dominated by the aponeuroses of the latissimus dorsi and the serratus posterior inferior. The deeper lamina of the PLF forms an encapsulating retinacular sheath around the paraspinal muscles. The middle layer of the TLF (MLF) appears to derive from an intermuscular septum that developmentally separates the epaxial from the hypaxial musculature. This septum forms during the fifth and sixth weeks of gestation. The paraspinal retinacular sheath (PRS) is in a key position to act as a ‘hydraulic amplifier’, assisting the paraspinal muscles in supporting the lumbosacral spine. This sheath forms a lumbar interfascial triangle (LIFT) with the MLF and PLF. Along the lateral border of the PRS, a raphe forms where the sheath meets the aponeurosis of the transversus abdominis. This lateral raphe is a thickened complex of dense connective tissue marked by the presence of the LIFT, and represents the junction of the hypaxial myofascial compartment (the abdominal muscles) with the paraspinal sheath of the epaxial muscles. The lateral raphe is in a position to distribute tension from the surrounding hypaxial and extremity muscles into the layers of the TLF. At the base of the lumbar spine all of the layers of the TLF fuse together into a thick composite that attaches firmly to the posterior superior iliac spine

  1. 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...

  2. 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.

  3. 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...

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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...

  12. 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…

  13. 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...

  14. 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.

  15. 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.

  16. 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.

  17. 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....

  18. 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

  19. 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.

  20. 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.

  1. Clinical outcomes, not clinical utility, should be the major consideration for saxagliptin with or without metformin

    Directory of Open Access Journals (Sweden)

    Doggrell SA

    2014-04-01

    Full Text Available Sheila A DoggrellDepartment of Pharmacology, School of Biomedical Sciences, Faculty of Health, Queensland University of Technology, Brisbane, QLD, AustraliaA recent review by Panagoulias and Doupis, published in Patient Preference and Adherence, concerned the saxagliptin/metformin fixed combination (SAXA/MET FDC, and was titled "Clinical utility in the treatment of type 2 diabetes with the saxagliptin/metformin fixed combination."1 This review concluded that "The SAXA/MET FDC is a patient-friendly, dosage-flexible, and hypoglycemia-safe regimen with very few adverse events and a neutral or even favorable effect on body weight. It achieves significant glycosylated hemoglobin A1c reduction helping the patient to achieve his/her individual glycemic goals."1View original paper by Panagoulias and Doupis.

  2. 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...

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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

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

    Directory of Open Access Journals (Sweden)

    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.

  10. 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.

  11. [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.

  12. 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.

  13. 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.

  14. 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.  ...

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. [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.

  4. 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.

  5. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  7. 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.

  8. 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)

  9. 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.

  10. 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.

  11. 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.)

  12. 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.

  13. 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

  14. 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.

  15. 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)

  16. 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...

  17. 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.

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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...

  3. 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.

  4. 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

  5. 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.

  6. 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)

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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...

  14. 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

  15. 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.

  16. 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...

  17. 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.

  18. 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.

  19. Clinical application of iodine 123 with special consideration of radionuclide purity, measuring accuracy and radiation dose

    International Nuclear Information System (INIS)

    Hermann, H.J.; Ammon, J.; Winkel, K. zum; Haubold, U.

    1975-01-01

    Iodine 123 is a nearly 'ideal' radionuclide for thyroid imaging. The production of Iodine 123 requires cyclotrons or accelerators. The production of multicurie amounts of Iodine 123 has been suggested through the use of high-energy accelerators (> 60 MeV). Most of the methods for the production of Iodine 123 using a compact cyclotron result in contamination with f.e. Iodine 124 which reduces the spatial resolution of imaging procedures and increases the radiation dose to the patient. The radiation dose has been calculated for three methods of production. The various contamination with Iodine 124, Iodine 125 and Iodine 126 result in comparable radiation dose of Iodine 131, provided that the time between production and application is more than four half-live-times of Iodine 123. (orig.) [de

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

    Directory of Open Access Journals (Sweden)

    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.

  1. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Science.gov (United States)

    2013-11-07

    .... 66, rm. 2110, Silver Spring, MD 20993-0002, 301- 796-5750. For devices regulated by CBER: Stephen... the best clinical and statistical practices for investigational medical device studies. A medical...

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

    Directory of Open Access Journals (Sweden)

    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.

  3. 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 ...

  4. 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.

  5. Ethical considerations in the translation of regenerative biofabrication technologies into clinic and society

    NARCIS (Netherlands)

    Otto, I A; Breugem, C C; Malda, J; Bredenoord, A L

    2016-01-01

    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

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. Beyond research: a primer for considerations on using viral metagenomics in the field and clinic

    NARCIS (Netherlands)

    Hall, Richard J; Draper, Jenny L; Nielsen, Fiona G G; Dutilh, Bas E

    2015-01-01

    Powered by recent advances in next-generation sequencing technologies, metagenomics has already unveiled vast microbial biodiversity in a range of environments, and is increasingly being applied in clinics for difficult-to-diagnose cases. It can be tempting to suggest that metagenomics could be used

  15. Pediatric obesity pharmacotherapy: current state of the field, review of the literature and clinical trial considerations.

    Science.gov (United States)

    Kelly, A S; Fox, C K; Rudser, K D; Gross, A C; Ryder, J R

    2016-07-01

    Despite the increasing number of medications recently approved to treat obesity among adults, few agents have been formally evaluated in children or adolescents for this indication. Moreover, there is a paucity of guidance in the literature addressing best practices with regard to pediatric obesity pharmacotherapy clinical trial design, and only general recommendations have been offered by regulatory agencies on this topic. The purposes of this article are to (1) offer a background of the current state of the field of pediatric obesity medicine, (2) provide a brief review of the literature summarizing pediatric obesity pharmacotherapy clinical trials, and (3) highlight and discuss some of the unique aspects that should be considered when designing and conducting high-quality clinical trials evaluating the safety and efficacy of obesity medications in children and adolescents. Suggestions are offered in the areas of target population and eligibility criteria, clinical trial end-point selection, trial duration, implementation of lifestyle modification therapy and recruitment and retention of participants. Efforts should be made to design and conduct trials appropriately to ensure that high-quality evidence is generated on the safety and efficacy of various medications used to treat pediatric obesity.

  16. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  18. 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

  19. 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.

  20. SPECIAL CONSIDERATIONS REGARDING WARFARIN DOSE TITRATION IN PATIENTS WITH ATRIAL FIBRILLATION DEPENDING ON CLINICAL FACTORS

    Directory of Open Access Journals (Sweden)

    E. L. Artanova

    2011-01-01

    Full Text Available Aim. To study the relations of clinical characteristics and individual warfarin dose titration in patients with atrial fibrillation. Material and methods. Period of warfarin dose titration was analyzed in 68 patients with atrial fibrillation due to ischemic heart disease. Adjusted warfarin dose in milligram, duration of dose titration in days and maximal international normalized ratio (INR were taken into account. Sex, age, history of myocardial infarction and stroke, concomitant diseases, amiodarone therapy were considered among clinical characteristics. Results. Adjusted warfarin dose was significantly higher in obesity , and it was lower in case of experienced myocardial infarction. The INR highest levels and maximal amplitudes of its fluctuations were observed in patients with thyroid gland nodes and smokers. Period of warfarin dose titration was longer in patients treated with amiodarone. Conclusion. Warfarin dose titration in patients with atrial fibrillation depends on the presence of myocardial infarction, obesity , thyroid nodular changes, smoking and amiodarone treatment.

  1. Phrenic Nerve Palsy and Regional Anesthesia for Shoulder Surgery: Anatomical, Physiologic, and Clinical Considerations.

    Science.gov (United States)

    El-Boghdadly, Kariem; Chin, Ki Jinn; Chan, Vincent W S

    2017-07-01

    Regional anesthesia has an established role in providing perioperative analgesia for shoulder surgery. However, phrenic nerve palsy is a significant complication that potentially limits the use of regional anesthesia, particularly in high-risk patients. The authors describe the anatomical, physiologic, and clinical principles relevant to phrenic nerve palsy in this context. They also present a comprehensive review of the strategies for reducing phrenic nerve palsy and its clinical impact while ensuring adequate analgesia for shoulder surgery. The most important of these include limiting local anesthetic dose and injection volume and performing the injection further away from the C5-C6 nerve roots. Targeting peripheral nerves supplying the shoulder, such as the suprascapular and axillary nerves, may be an effective alternative to brachial plexus blockade in selected patients. The optimal regional anesthetic approach in shoulder surgery should be tailored to individual patients based on comorbidities, type of surgery, and the principles described in this article.

  2. 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.

  3. 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.

  4. 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.

  5. Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

    Science.gov (United States)

    Scrivani, Peter V; Erb, Hollis N

    2013-01-01

    High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

  6. SPECIAL CONSIDERATIONS REGARDING WARFARIN DOSE TITRATION IN PATIENTS WITH ATRIAL FIBRILLATION DEPENDING ON CLINICAL FACTORS

    OpenAIRE

    E. L. Artanova; E. V. Saleeva; I. M. Sokolov; Y. G. Shvarts

    2011-01-01

    Aim. To study the relations of clinical characteristics and individual warfarin dose titration in patients with atrial fibrillation. Material and methods. Period of warfarin dose titration was analyzed in 68 patients with atrial fibrillation due to ischemic heart disease. Adjusted warfarin dose in milligram, duration of dose titration in days and maximal international normalized ratio (INR) were taken into account. Sex, age, history of myocardial infarction and stroke, concomitant diseases, a...

  7. Beyond research: a primer for considerations on using viral metagenomics in the field and clinic

    OpenAIRE

    Hall, Richard J.; Draper, Jenny L.; Nielsen, Fiona G. G.; Dutilh, Bas E.

    2015-01-01

    Powered by recent advances in next-generation sequencing technologies, metagenomics has already unveiled vast microbial biodiversity in a range of environments, and is increasingly being applied in clinics for difficult-to-diagnose cases. It can be tempting to suggest that metagenomics could be used as a “universal test” for all pathogens without the need to conduct lengthy serial testing using specific assays. While this is an exciting prospect, there are issues that need to be addressed bef...

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

    Directory of Open Access Journals (Sweden)

    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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. [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.

  15. 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.

  16. 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)

  17. Implementing PGD/PGD-A in IVF clinics: considerations for the best laboratory approach and management.

    Science.gov (United States)

    Capalbo, Antonio; Romanelli, Valeria; Cimadomo, Danilo; Girardi, Laura; Stoppa, Marta; Dovere, Lisa; Dell'Edera, Domenico; Ubaldi, Filippo Maria; Rienzi, Laura

    2016-10-01

    For an IVF clinic that wishes to implement preimplantation genetic diagnosis for monogenic diseases (PGD) and for aneuploidy testing (PGD-A), a global improvement is required through all the steps of an IVF treatment and patient care. At present, CCS (Comprehensive Chromosome Screening)-based trophectoderm (TE) biopsy has been demonstrated as a safe, accurate and reproducible approach to conduct PGD-A and possibly also PGD from the same biopsy. Key challenges in PGD/PGD-A implementation cover genetic and reproductive counselling, selection of the most efficient approach for blastocyst biopsy as well as of the best performing molecular technique to conduct CCS and monogenic disease analysis. Three different approaches for TE biopsy can be compared. However, among them, the application of TE biopsy approaches, entailing the zona opening when the expanded blastocyst stage is reached, represent the only biopsy methods suited with a totally undisturbed embryo culture strategy (time lapse-based incubation in a single media). Moreover, contemporary CCS technologies show a different spectrum of capabilities and limits that potentially impact the clinical outcomes, the management and the applicability of the PGD-A itself. In general, CCS approaches that avoid the use of whole genome amplification (WGA) can provide higher reliability of results with lower costs and turnaround time of analysis. The future perspectives are focused on the scrupulous and rigorous clinical validations of novel CCS methods based on targeted approaches that avoid the use of WGA, such as targeted next-generation sequencing technology, to further improve the throughput of analysis and the overall cost-effectiveness of PGD/PGD-A.

  18. 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.

  19. 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.

  20. 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.

  1. Medical specialty considerations by medical students early in their clinical experience

    Directory of Open Access Journals (Sweden)

    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

  2. Clinical considerations in the management of inflammatory periodontal diseases in children and adolescents.

    Science.gov (United States)

    Cabanilla, Leyvee; Molinari, Gail

    2009-01-01

    Periodontal diseases and conditions, as defined by The 1999 International Workshop for Classification of Periodontal Diseases and Conditions presented some significant paradigm shifts based on evidence that the transition from plaque-associated reversible gingival diseases to periodontitis can occur in children and adolescents with characteristics which were previously thought to be typical of adult periodontitis. The purposes of this paper are to present the periodontal diseases and conditions described in the 1999 workshop sponsored by the American Academy of Periodontology, review the risk factors for the development of periodontal diseases in the pediatric and adolescent populations, and present appropriate clinical periodontal assessment and management for these age groups.

  3. 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

  4. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  6. 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.

  7. Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations

    Science.gov (United States)

    Turk, Dennis C.; O’Connor, Alec B.; Dworkin, Robert H.; Chaudhry, Amina; Katz, Nathaniel P.; Adams, Edgar H.; Brownstein, John S.; Comer, Sandra D.; Dart, Richard; Dasgupta, Nabarun; Denisco, Richard A.; Klein, Michael; Leiderman, Deborah B.; Lubran, Robert; Rappaport, Bob A.; Zacny, James P.; Ahdieh, Harry; Burke, Laurie B.; Cowan, Penney; Jacobs, Petra; Malamut, Richard; Markman, John; Michna, Edward; Palmer, Pamela; Peirce-Sandner, Sarah; Potter, Jennifer S.; Raja, Srinivasa N.; Rauschkolb, Christine; Roland, Carl L.; Webster, Lynn R.; Weiss, Roger D.; Wolf, Kerry

    2013-01-01

    Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Due to the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs in order to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies assessing: (1) abuse liability; (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation; (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse; and (4) post-marketing epidemiological studies. PMID:22770841

  8. Endoscopic endonasal anatomy of superior orbital fissure and orbital apex regions: critical considerations for clinical applications.

    Science.gov (United States)

    Dallan, Iacopo; Castelnuovo, Paolo; de Notaris, Matteo; Sellari-Franceschini, Stefano; Lenzi, Riccardo; Turri-Zanoni, Mario; Battaglia, Paolo; Prats-Galino, Alberto

    2013-05-01

    The superior orbital fissure is a critical three-dimensional space connecting the middle cranial fossa and the orbit. From an endoscopic viewpoint, only the medial aspect has a clinical significance. It presents a critical relationship with the lateral sellar compartment, the pterygopalatine fossa and the middle cranial fossa. The connective tissue layers and neural and vascular structures of this region are described. The role of Muller's muscle is confirmed, and the utility of the maxillary and optic strut is outlined. Muller's muscle extends for the whole length of the inferior orbital fissure, passes over the maxillary strut and enters the superior orbital fissure, representing a critical surgical landmark. Dividing the tendon between the medial and inferior rectus muscle allows the identification of the main trunk of the oculomotor nerve, and a little laterally, it is usually possible to visualize the first part of the ophthalmic artery. Based on a better knowledge of anatomy, we trust that this area could be readily addressed in clinical situations requiring an extended approach in proximity of the orbital apex.

  9. The clinical significance of computerized axial tomography (CAT) in consideration of conventional diagnostic methods

    International Nuclear Information System (INIS)

    Huenig, R.

    1976-01-01

    Regarding CAT of the intracranial region, the article informs on a) techniques of examination including the production of normal structures, b) the recognizable pathological changes, c) possibilities of enhancement, d) possibilities of course observation, e) limitations of the methods, as well as on f) risk/benefit aspects g) benefit/cost calculations as compared to conventional methods, and on h) the influence of CAT on the frequency of conventional methods of examination. Regarding CAT of the extracranial region, the information available up to the meeting is reported on. (orig./LH) [de

  10. 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

  11. 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

  12. 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...

  13. 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...

  14. Lifestyle measures in the management of gastro-oesophageal reflux disease: clinical and pathophysiological considerations.

    Science.gov (United States)

    Kang, J H-E; Kang, J Y

    2015-03-01

    Several lifestyle and dietary factors are commonly cited as risk factors for gastro-oesophageal reflux disease (GORD) and modification of these factors has been advocated as first-line measures for the management of GORD. We performed a systematic review of the literature from 2005 to the present relating to the effect of these factors and their modification on GORD symptoms, physiological parameters of reflux as well as endoscopic appearances. Conflicting results existed for the association between smoking, alcohol and various dietary factors in the development of GORD. These equivocal findings are partly due to methodology problems. There is recent good evidence that weight reduction and smoking cessation are beneficial in reducing GORD symptoms. Clinical and physiological studies also suggest that some physical measures as well as modification of meal size and timing can also be beneficial. However, there is limited evidence for the role of avoiding alcohol and certain dietary ingredients including carbonated drinks, caffeine, fat, spicy foods, chocolate and mint.

  15. 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'.

  16. Benign bone-forming lesions: osteoma, osteoid osteoma, and osteoblastoma; Clinical, imaging, pathologic, and differential considerations

    Energy Technology Data Exchange (ETDEWEB)

    Greenspan, A. (Depts. of Radiology and Orthopedic Surgery, California Univ., Davis School of Medicine, Sacramento, CA (United States) Section of Musculoskeletal Radiology, UC Davis Medical Center, Sacramento, CA (United States))

    1993-10-01

    The benign bone lesions - osteoma, osteoid osteoma, and osteoblastoma - are characterized as bone-forming because tumor cells produce osteoid or mature bone. Osteoma is a slow-growing lesion most commonly seen in the paranasal sinuses and in the calvaria. When it occurs in the long bones, it is invariably juxtacortical and may need to be differentiated from, among others, parosteal osteosarcoma, sessile osteochondroma, and a matured juxtacortical focus of myositis ossificans. Osteoid osteoma and osteoblastoma appear histologically very similar. Their clinical presentations and distribution in the skeleton, however, are distinct: osteoid osteoma is usually accompanied by nocturnal pain promptly relieved by salicylates; osteoblastoma arises predominantly in the axial skeleton, spinal lesions constituting one-third of reported cases. This review focuses on the application of the various imaging modalities in the diagnosis, differential diagnosis, and evaluation of these lesions. Their histopathology also is discussed, and their treatment briefly outlined. (orig.)

  17. "HUMAN AURICULAR MYIASIS CAUSED BY LUCILIA SERICATA: CLINICAL AND PARASITOLOGICAL CONSIDERATIONS"

    Directory of Open Access Journals (Sweden)

    R. Yaghoobi

    2005-05-01

    Full Text Available Myiasis is the invasion of body tissues of humans and animals by the larvae of the Diptera or two-winged flies. There are only sporadic reports in the literature concerning human ear myiasis. A 62-year-old bedridden woman in an intensive care unit was examined because of her intense swollen and erythematous right ear. Physical examination revealed 80 live larvae (maggots in the posterior part of right outer ear and external auditory canal. Entomological studies of the third instar larvae revealed it’s identity as Lucilia sericata. The entomological aspects, clinical and epidemiological characteristics are evaluated. In particular, we underline the rarity of myiasis because of both etiological agent and the anatomical site.

  18. Invasive Pleomorphic Lobular Carcinoma of the Breast: Pathologic, Clinical, and Therapeutic Considerations.

    Science.gov (United States)

    Al-Baimani, Khalid; Bazzarelli, Amy; Clemons, Mark; Robertson, Susan J; Addison, Christina; Arnaout, Angel

    2015-12-01

    Pleomorphic lobular carcinoma is an uncommon form of breast cancer and a subtype of invasive lobular carcinoma. It has unique histopathologic features that translate to a more aggressive phenotype with an associated poor prognosis. Unlike classical invasive lobular carcinoma, it can lose estrogen and progesterone receptor expression and demonstrate HER-2/neu amplification. It remains to be determined, however, whether the pleomorphic histology independently predicts a worse outcome or whether other known associated negative prognostic factors such as larger tumor size, increased metastatic disease, and associated worse molecular subtypes commonly present in pleomorphic carcinoma account for the poor prognosis. Here we present an updated review of the unique pathologic and clinical features of pleomorphic lobular carcinoma needed to guide management for women with this subtype of cancer. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Quagmires for clinical psychology and executive coaching? Ethical considerations and practice challenges.

    Science.gov (United States)

    Gebhardt, Judith Ann

    2016-04-01

    As the coaching field burgeons, both the mental health and coaching professionals, and their respective professions, face a myriad of potential quagmires, especially if the unique challenges encountered are ignored. After a short introduction and presentation on ethics and morals related to executive coaching and clinical therapy, a discussion follows on the lengthy and intimate relationship between executive coaching and psychology. Next are definitions and comparisons and 6 areas that are potential quagmires. This includes roles, skill sets/core competencies, education/training, licensing/credentialing-certification, governing bodies and confidentiality, and fees/reimbursement. Each section includes a discussion and several questions to highlight potentially problematic areas, practice challenges, and/or ethical issues, followed with brief responses. This paper concludes with the inquiry, "Where do we go from here?" (c) 2016 APA, all rights reserved).

  20. Adrenal Disorders and the Paediatric Brain: Pathophysiological Considerations and Clinical Implications

    Directory of Open Access Journals (Sweden)

    Vincenzo Salpietro

    2014-01-01

    Full Text Available Various neurological and psychiatric manifestations have been recorded in children with adrenal disorders. Based on literature review and on personal case-studies and case-series we focused on the pathophysiological and clinical implications of glucocorticoid-related, mineralcorticoid-related, and catecholamine-related paediatric nervous system involvement. Childhood Cushing syndrome can be associated with long-lasting cognitive deficits and abnormal behaviour, even after resolution of the hypercortisolism. Exposure to excessive replacement of exogenous glucocorticoids in the paediatric age group (e.g., during treatments for adrenal insufficiency has been reported with neurological and magnetic resonance imaging (MRI abnormalities (e.g., delayed myelination and brain atrophy due to potential corticosteroid-related myelin damage in the developing brain and the possible impairment of limbic system ontogenesis. Idiopathic intracranial hypertension (IIH, a disorder of unclear pathophysiology characterised by increased cerebrospinal fluid (CSF pressure, has been described in children with hypercortisolism, adrenal insufficiency, and hyperaldosteronism, reflecting the potential underlying involvement of the adrenal-brain axis in the regulation of CSF pressure homeostasis. Arterial hypertension caused by paediatric adenomas or tumours of the adrenal cortex or medulla has been associated with various hypertension-related neurological manifestations. The development and maturation of the central nervous system (CNS through childhood is tightly regulated by intrinsic, paracrine, endocrine, and external modulators, and perturbations in any of these factors, including those related to adrenal hormone imbalance, could result in consequences that affect the structure and function of the paediatric brain. Animal experiments and clinical studies demonstrated that the developing (i.e., paediatric CNS seems to be particularly vulnerable to alterations induced by

  1. 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...

  2. 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…

  3. FDA drug safety communications: a narrative review and clinical considerations for older adults.

    Science.gov (United States)

    Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

    2012-08-01

    The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

  4. 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

  5. Non-clinical models: validation, study design and statistical consideration in safety pharmacology.

    Science.gov (United States)

    Pugsley, M K; Towart, R; Authier, S; Gallacher, D J; Curtis, M J

    2010-01-01

    The current issue of the Journal of Pharmacological and Toxicological Methods (JPTM) focuses exclusively on safety pharmacology methods. This is the 7th year the Journal has published on this topic. Methods and models that specifically relate to methods relating to the assessment of the safety profile of a new chemical entity (NCE) prior to first in human (FIH) studies are described. Since the Journal started publishing on this topic there has been a major effort by safety pharmacologists, toxicologists and regulatory scientists within Industry (both large and small Pharma as well as Biotechnology companies) and also from Contract Research Organizations (CRO) to publish the surgical details of the non-clinical methods utilized but also provide important details related to standard and non-standard (or integrated) study models and designs. These details from core battery and secondary (or ancillary) drug safety assessment methods used in drug development programs have been the focus of these special issues and have been an attempt to provide validation of methods. Similarly, the safety pharmacology issues of the Journal provide the most relevant forum for scientists to present novel and modified methods with direct applicability to determination of drug safety-directly to the safety pharmacology scientific community. The content of the manuscripts in this issue includes the introduction of additional important surgical methods, novel data capture and data analysis methods, improved study design and effects of positive control compounds with known activity in the model. Copyright 2010 Elsevier Inc. All rights reserved.

  6. Type III B dens invaginatus: Diagnostic and clinical considerations using 128-slice computed tomography

    Directory of Open Access Journals (Sweden)

    Radhika Muppa

    2014-01-01

    Full Text Available Endodontic therapy is successful only when thorough knowledge of root canal morphology is understood. Dens invaginatus is malformation of teeth resulting from invagination of tooth before biological mineralization occurs. It is clinically significant with an early pulpal involvement and chronic periapical lesion, which are often associated with this anomaly. The present case report describes a 13-year-old female patient who reported to our institution with complaint of pain and swelling in the right maxillary region. Intraoral examination revealed Ellis Type II fracture of right maxillary central incisor and normal appearing right maxillary lateral incisor. On radiographic examination right maxillary, lateral incisor roots are morphologically altered with an immature apex and a large periradicular lesion. Conventional radiographs help in the assessment of complex root morphology, but certain limitations pertaining to detail of complexity needs for the use of more advance imaging modalities. Complex anatomic variations can best be diagnosed with the use of computed tomography (CT. A combined endodontic and surgical treatment was performed followed by postobturation CT images which were reviewed as axial slices and in volume rendering multiplanar reconstruction. The scope of using spiral CT in the endodontic diagnosis and treatments is increasing as it provides better resolution than other methods.

  7. Clinical nutrition counselling service in the veterinary hospital: retrospective analysis of equine patients and nutritional considerations.

    Science.gov (United States)

    Vergnano, D; Bergero, D; Valle, E

    2017-06-01

    Nutrition plays a very important role in the healthy and in the ill horse. Although research in this field clearly shows that incorrect nutritional practices may lead to severe pathologies, inappropriate feeding plans often continue to be used. A clinical nutrition counselling (CNC) service could thus be of great use to both horse owners and veterinarians. The aim of this study was to provide information on equine patients referred to the CNC service of the University of Turin and to provide standard dietary protocols as used in our Veterinary Teaching Hospital for the most common nutrition-related pathologies. The data were obtained by retrospective analysis of the nutritional records of referred equine patients. The data collected included information about anamnesis, nutritional assessment, current diet, referring person and follow-up of each patient. Sixty-one horses were included in the study. The majority were adult males. The most common breeds were the Italian Saddle Horse and the Friesian Horse. Old horses (>19 years) had a statistically lower BCS than brood mares or other adult horses (p equine gastric ulcer syndrome. All horses received first-cut meadow hay; 85% also ate concentrates. Young horses (equine population. Journal of Animal Physiology and Animal Nutrition © 2017 Blackwell Verlag GmbH.

  8. Case report of a pustular dermatitis outbreak in sheep: Clinical and food safety considerations

    Directory of Open Access Journals (Sweden)

    Mariana Roccaro

    2018-04-01

    Full Text Available The objective of this report is to describe an outbreak of pustular dermatitis in a flock of about 200 sheep, its clinical evolution and food safety implications. The onset of the symptoms was sudden and the lesions spread very quickly from ewe to ewe, so that in about 3 days almost all of the lactating sheep were stricken. Pustules from 5 different animals, six milk samples, two cheese samples, teat cup samples from the milking machine and farmer’s hands were analysed. A pure culture of Staphylococcus aureus, producing staphylococcal enterotoxin (SE C, was isolated from pustules. Milk and cheese showed a contamination by coagulase positive staphylococci <15 and 30 colony forming units respectively and the absence of SE. Farmer’s hands and teat cups samples resulted negative for coagulase positive staphylococci. Therapy with daily topical medicaments was prescribed and a prophylactic intervention was suggested by the administration of an autovaccine. The low level of milk and cheese contamination and the absence of SE in cheese supported the decision to not advise the farmer to recall cheese produced with milk from affected animals.

  9. Submitted for your consideration: potential advantages of a novel clinical trial design and initial patient reaction

    Directory of Open Access Journals (Sweden)

    Matthew Shane Loop

    2012-08-01

    Full Text Available In many circumstances, individuals do not respond identically to the same treatment. This phenomenon, which is called treatment response heterogeneity (TRH, appears to be present in treatments for many conditions, including obesity. Estimating the total amount of TRH, predicting an individual’s response, and identifying the mediators of TRH are of interest to biomedical researchers. Clinical investigators and physicians commonly postulate that some of these mediators could be genetic. Current designs can estimate TRH as a function of specific, measurable observed factors; however, they cannot estimate the total amount of TRH, nor provide reliable estimates of individual persons’ responses. We propose a new repeated randomizations design (RRD, which can be conceived as a generalization of the Balaam design, that would allow estimates of that variability and facilitate estimation of the total amount of TRH, prediction of an individual’s response, and identification of the mediators of TRH. In a pilot study, we asked 118 subjects entering a weight loss trial for their opinion of the RRD, and they stated a preference for the RRD over the conventional 2-arm parallel groups design. Research is needed as to how the RRD will work in practice and its relative statistical properties, and we invite dialogue about it.

  10. [Clinical and therapeutical considerations regarding the diagnosis and treatment in meconial disease].

    Science.gov (United States)

    Sabetay, C; Ciobanu, O; Zavate, A; Ciucă, M; Malos, A; Marin-Diu, B

    2010-01-01

    The meconium disease represents a problem of great impact over the vital prognosis of the newborn, the mortality of this disease being rated in various studies between 30 and 50%. The meconial disease that reunites the meconial ileus and the meconial peritonitis is often associated with cystic fibrosis a disease of general impact over the entire organism increasing the gravity and influencing the vital prognosis of these patients. The authors' purpose is to evaluate the results obtained after the treatment of the meconial disease in the Pediatric Surgery Clinic of the Emergency Hospital of Craiova over a period of 10 years. The study has been made on a number of 16 cases of meconial ileus, plug and peritonitis analising the difficulty of the diagnostic process, the preoperative care as well as the possibilities of surgical treatment. The surgical treatment is composed of multiple procedures including simple suture of the bowel defect and segmentary bowel resections with primary anastomosis and/or secondary anastomosis after ileostoma. The mortality on the studied cases was of 37.5% despite recent progresses achieved in postoperative care of these type of patients.

  11. Donor Selection for Allogenic Hemopoietic Stem Cell Transplantation: Clinical and Ethical Considerations

    Directory of Open Access Journals (Sweden)

    Irene Riezzo

    2017-01-01

    Full Text Available Allogenic hematopoietic progenitor cell transplantation (allo-HSCT is an established treatment for many diseases. Stem cells may be obtained from different sources: mobilized peripheral blood stem cells, bone marrow, and umbilical cord blood. The progress in transplantation procedures, the establishment of experienced transplant centres, and the creation of unrelated adult donor registries and cord blood banks gave those without an human leucocyte antigen- (HLA- identical sibling donor the opportunity to find a donor and cord blood units worldwide. HSCT imposes operative cautions so that the entire donation/transplantation procedure is safe for both donors and recipients; it carries with it significant clinical, moral, and ethical concerns, mostly when donors are minors. The following points have been stressed: the donation should be excluded when excessive risks for the donor are reasonable, donors must receive an accurate information regarding eventual adverse events and health burden for the donors themselves, a valid consent is required, and the recipient’s risks must be outweighed by the expected benefits. The issue of conflict of interest, when the same physician has the responsibility for both donor selection and recipient care, is highlighted as well as the need of an adequate insurance protection for all the parties involved.

  12. The clinical and radiological consideration of calcifying odontogenic cyst of the jaw

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Hae Rym; Kim, Kee Deog; Park, Chang Seo [Dept. of Dental radiology, College of Dentistry, Yensei University, (Korea, Republic of)

    1996-08-15

    Nine cases presented with a calcifying odontogenic cyst to the Dental Hospital of the College of Dentistry, Yonsei University, from January 1987 to September June, 1996, Clinical or histopathological findings were observed according to each radiologic criteria. The results obtained are as follows:1. The male to female ratio was 2 : 1 with a mean age of 25 years. 2. The radiographic appearances of nine caes were well-defined radiolucent lesions in which eight cases were shown until ocular lesions and only one lesion was seen multilocular lesion. 3. Radiologically, three of nine cases were pure radiolucent lesion and others, six cases were radiolucent contained a variable amount of radiopaque material. 4. Histologically, two cases were classified simple cyst, five were cyst associated odontoma, two were neoplastic type. 5. Histological findings according to the radiological classification, two of three radiolucent lesions were simple cys ts; another was a cyst associated with odontoma. While, four of six radiologic mixed lesions turned out to be a cyst associated with odontoma, two was the neoplastic type.

  13. [Stalking: clinical and criminological considerations through the results of a research contribution].

    Science.gov (United States)

    Pomilla, Antonella; D'Argenio, Alberto; Mastronardi, Vincenzo

    2012-01-01

    Among the extensive results supplied by the psychiatric literature on the subject of stalking, few studies focus on the analysis of persecutory behaviors carried out against mental health professionals, who also identified as one of the most affected sample of victims. Particularly, for studies conducted in this way, further examination requires differentiation according to gender type into the social and personal characteristics of the authors' behavior patterns displayed towards the victims. Aim. To obtaine results by an epidemiological survey conducted in public and private psychiatric care structures in the city of Rome, to assess the incidence of the phenomenon as well as gender differences in behavior patterns practised out by the author for the two sample considered. Methods. Administration of a questionnaire to a sample make up by psychiatrists working in out-patient services for the Departments of Mental Health (ASL) of Rome and to a sample of psychiatrists who practise their professional activity in the private sector. Results. Regarding the incidence of the phenomenon, an increased presence has been found in private mental health care settings in comparison to the public service; regarding to the distribution of the phenomenon according to the sexual identity of the authors among the two samples analyzed, a statistical prevalence of female authors has been found in the sample of private sector. Discussion. The health's professionals, so much liable of victimization, are poorly formed on the phenomenon. So it's urgent to operate with integrated approaches (informative trainings; strengthening of administrative and clinical policies of the profession; multidimensional assessment).

  14. 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.

  15. 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,

  16. 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...

  17. 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...

  18. 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...

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

    Directory of Open Access Journals (Sweden)

    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.

  20. Ecological and biological considerations for sustainable management of non-timber forest products in northern forests

    Science.gov (United States)

    Luc C. Duchesne; John C. Zasada; Iain. Davidson-Hunt

    2001-01-01

    With a current output of over $241 million per year, non-timber forest products (NTFPs) contribute significantly to the welfare of rural and First Nations communities in Canada. Maple sap products, wild mushrooms, and wild fruits are the most important NTFPs for consumption both in Canada and abroad. However, because of increased access to international markets by...

  1. Risk management in clinical practice. Part 5. Ethical considerations for dental enhancement procedures.

    Science.gov (United States)

    Ahmad, I

    2010-09-11

    After the demise of the Industrial Age, we currently live in an 'Information Age' fuelled mainly by the Internet, with an ever-increasing medically and dentally literate population. The media has played its role by reporting scientific advances, as well as securitising medical and dental practices. Reality television such as 'Extreme makeovers' has also raised public awareness of body enhancements, with a greater number of people seeking such procedures. To satiate this growing demand, the dental industry has flourished by introducing novel cosmetic products such as bleaching kits, tooth coloured filling materials and a variety of dental ceramics. In addition, one only has to browse through a dental journal to notice innumerable courses and lectures on techniques for providing cosmetic dentistry. The incessant public interest, combined with unrelenting marketing by companies is gradually shifting the balance of dental care from a healing to an enhancement profession. The purpose of this article is to endeavour to answer questions such as, What is aesthetic or cosmetic dentistry? Why do patients seek cosmetic dentistry? Are enhancement procedures a part of dental practice? What, if any, ethical guidelines and constraints apply to elective enhancement procedures? What is the role of the dentist in providing or encouraging this type of 'therapy'? What treatment modalities are available for aesthetic dental treatment?

  2. Volatile substance misuse : clinical considerations, neuropsychopharmacology and potential role of pharmacotherapy in management.

    Science.gov (United States)

    Garland, Eric L; Howard, Matthew O

    2012-11-01

    Volatile substance misuse is among the most prevalent and toxic forms of psychoactive drug use, and often results in highly deleterious social, psychological and medical consequences. The prevalence of this pernicious form of substance misuse owes in part to the fact that volatile substances of misuse are ubiquitous in the natural environment. Commonly misused commercial products include glue, shoe polish, nail polish remover, butane lighter fluid, gasoline and computer duster spray. National samples of volatile substance misusers tend to exhibit high rates of psychiatric problems and antisocial behaviour. In addition, cognitive impairments and affective dysregulation are often observed among these individuals. Volatile substances exert their complex neuropharmacological effects on dopaminergic, glutamatergic, GABAergic and serotoninergic receptor systems, as well as on cell membranes and ion channels. Concomitantly, pharmacotherapies for volatile substance abuse might profitably target a number of mechanisms, including reward circuitry in the brain, symptoms of craving and withdrawal, neuropsychiatric and emotional impairments that promote volatile substance abuse, and cognitive enhancement to rectify deficits in executive function. This review details the modes of use, subjective effects, epidemiology, adverse consequences, neuropsychopharmacology and drug treatment of volatile substance misuse, and discusses the potential role of novel forms of pharmacological intervention for this oft-overlooked public health threat of epidemic proportions.

  3. Expression of DNA repair genes in ovarian cancer samples: biological and clinical considerations.

    Science.gov (United States)

    Ganzinelli, M; Mariani, P; Cattaneo, D; Fossati, R; Fruscio, R; Corso, S; Ricci, F; Broggini, M; Damia, G

    2011-05-01

    The purpose of this study was to investigate retrospectively the mRNA expression of genes involved in different DNA repair pathways implicated in processing platinum-induced damage in 171 chemotherapy-naïve ovarian tumours and correlate the expression of the different genes with clinical parameters. The expression of genes involved in DNA repair pathways (PARP1, ERCC1, XPA, XPF, XPG, BRCA1, FANCA, FANCC, FANCD2, FANCF and PolEta), and in DNA damage transduction (Chk1 and Claspin) was measured by RT-PCR in 13 stage I borderline and 77 stage I and 88 III ovarian carcinomas. ERCC1, XPA, XPF and XPG genes were significantly less expressed in stage III than in stage I carcinoma; BRCA1, FANCA, FANCC, FANCD2 gene expressions were low in borderline tumours, higher in stage I carcinomas and lower in stage III samples. High levels of ERCC1, XPA, FANCC, XPG and PolEta correlated with an increase in Overall Survival (OS) and Progression Free Survival (PFS), whilst high BRCA1 levels were associated with PFS on univariate analysis. With multivariate analyses no genes retained an association when adjusted by stage, grade and residual tumour. A tendency towards a better PFS was observed in patients with the highest level of ERCC1 and BRCA1 after platinum-based therapy than those given both platinum and taxol. The expression of DNA repair genes differed in borderline stage I, stage I and stage III ovarian carcinomas. The role of DNA repair genes in predicting the response in ovarian cancer patients seems far from being established. Copyright © 2010 Elsevier Ltd. All rights reserved.

  4. A Study on clinical Considerations caused by inevitably Extended SSD for Electron beam therapy

    International Nuclear Information System (INIS)

    Lee, Jung Woo; Kim, Jeong Man

    1996-01-01

    We are often faced with the clinical situations that is inevitably extended SSD for electron beam therapy due to anatomical restriction or applicator structure. But there are some difficulties in accurately predicting output and properties. In electron beam treatment , unlike photon beam the decrease in output for extended SSD does not follow inverse-square law accurately because of a loss of side scatter equilibrium, which is particularly significant for small cone size and low energies. The purpose of our study is to analyze the output in changing with the energy, cone size, air gap beyond the standard SSD and to compare inverse-square law factor derived from calculated effective SSD, mominal SSD with measured output factor. In addition, we have analyzed the change of PDD for several cones with different SSDs which range from 100 cm to 120 cm with 5 cm step and with different energies(6 MeV, 9 MeV, 12 MeV, 16 MeV, 20 MeV). In accordance with our study, an extended SSD produces a significant change in beam output, negligible change in depth dose which range from 100 cm to 120 cm SSDs. In order to deliver the more accurate dose to the neoplastic tissue, first of all we recommend inverse-square law using the table of effective SSDs with cone sizes and energies respectively or simply to create a table of extended SSD air gap correction factor. The second we need to have an insight into some change of dose distribution including PPD, penumbra caused by extended SSD for electron beam therapy.

  5. Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?

    Science.gov (United States)

    Gilligan, Peter H; Miller, Melissa B

    2016-02-02

    Over a million prosthetic joints are placed in patients in the United States annually. Of those that fail, 25% will be due to infection, with an estimated cost approaching 1 billion dollars. Despite the clinical and economic importance of these infections, the techniques for their detection are relatively insensitive. An innovative method for detecting these infections by using blood culture bottles (BCB) to culture specimens of periprosthetic tissue (PPT) was described in a recent article [T. N. Peel, et al., mBio 7(1):e01776-15, 2016, doi:10.1128/mBio.01776-15]. There are two potential stumbling blocks to the widespread implementation of this innovation. First, the FDA judges such an application of BCB as an "off-label use" and as such, a laboratory-developed test (LDT). LDTs are coming under greater scrutiny by the FDA and may require extensive, costly validation studies in laboratories that adopt this methodology. Second, the Center for Medicare and Medicaid Services has established a Hospital Acquired Condition Reduction Act under which institutions performing in the lowest quartile forfeit 1% of their Medicare reimbursement. Hospital-acquired infections are an important component of this quality metric. Although prosthetic joint infection (PJI) rates are not currently a hospital quality metric, given their cost and increasing frequency, it is reasonable to expect that they may become one. Will those with financial oversight allow an innovative technique that will require an expensive validation and may put the institution at risk for loss of CMS reimbursement? Copyright © 2016 Gilligan and Miller.

  6. Bringing stability to the COPD patient: clinical and pharmacological considerations for frequent exacerbators

    Science.gov (United States)

    Gulati, Swati

    2017-01-01

    Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are critical events associated with accelerated loss of lung function, increased morbidity, and excess mortality. AECOPD are heterogeneous in nature and this may directly impact clinical decision making, specifically in patients with frequent exacerbations. A “frequent exacerbator” is a sub-phenotype of COPD that is defined as an individual who experiences ≥2 moderate to severe exacerbations per year. This distinct subgroup has higher mortality and account for more than half of COPD-related hospitalizations annually. Thus, it is imperative to identify individuals at risk for frequent exacerbations and choose optimal strategies to minimize risk for these events. New paradigms for utilizing combination inhalers and the introduction of novel oral compounds provide expanded treatment options to reduce the risk and frequency of exacerbations. The goals of managing frequent exacerbators or patients at risk for AECOPD are: 1) maximizing bronchodilation, 2) reducing inflammation, and 3) targeting specific molecular pathways implicated in COPD and AECOPD pathogenesis. Novel inhaler therapies include combination long acting muscarinic agents (LAMA) plus long acting beta agonists (LABA) show promising results compared to monotherapy or LABA inhaled corticosteroid (ICS) combination in reducing exacerbation risk among individuals at risk for exacerbations and among frequent exacerbators. Likewise, oral medications including macrolides and phosphodiesterase (PDE4) inhibitors reduce the risk for AECOPD in select groups of individuals at high risk for exacerbation. Future direction in COPD management is based on identification of various subtypes or “endotypes” and targeting therapies based on their pathophysiology. This review aims to describe the impact of AECOPD, challenges posed by frequent exacerbators, and explores the rationale for different pharmacologic approaches to preventing AECOPD in these

  7. 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.

  8. 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 %.

  9. Stereotactic Ablative Radiation Therapy for Subcentimeter Lung Tumors: Clinical, Dosimetric, and Image Guidance Considerations

    International Nuclear Information System (INIS)

    Louie, Alexander V.; Senan, Suresh; Dahele, Max; Slotman, Ben J.; Verbakel, Wilko F.A.R.

    2014-01-01

    Purpose: Use of stereotactic ablative radiation therapy (SABR) for subcentimeter lung tumors is controversial. We report our outcomes for tumors with diameter ≤1 cm and their visibility on cone beam computed tomography (CBCT) scans and retrospectively evaluate the planned dose using a deterministic dose calculation algorithm (Acuros XB [AXB]). Methods and Materials: We identified subcentimeter tumors from our institutional SABR database. Tumor size was remeasured on an artifact-free phase of the planning 4-dimensional (4D)-CT. Clinical plan doses were generated using either a pencil beam convolution or an anisotropic analytic algorithm (AAA). All AAA plans were recalculated using AXB, and differences among D95 and mean dose for internal target volume (ITV) and planning target volume (PTV) on the average intensity CT dataset, as well as for gross tumor volume (GTV) on the end respiratory phases were reported. For all AAA patients, CBCT scans acquired during each treatment fraction were evaluated for target visibility. Progression-free and overall survival rates were calculated using the Kaplan-Meier method. Results: Thirty-five patients with 37 subcentimeter tumors were eligible for analysis. For the 22 AAA plans recalculated using AXB, Mean D95 ± SD values were 2.2 ± 4.4% (ITV) and 2.5 ± 4.8% (PTV) lower using AXB; whereas mean doses were 2.9 ± 4.9% (ITV) and 3.7 ± 5.1% (PTV) lower. Calculated AXB doses were significantly lower in one patient (difference in mean ITV and PTV doses, as well as in mean ITV and PTV D95 ranged from 22%-24%). However, the end respiratory phase GTV received at least 95% of the prescription dose. Review of 92 CBCT scans from all AAA patients revealed that the tumor was visualized in 82 images, and its position could be inferred in other images. The 2-year local progression-free survival was 100%. Conclusions: Patients with subcentimeter lung tumors are good candidates for SABR, given the dosimetry, ability to localize

  10. 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.

  11. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  13. 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?

  14. 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.

  15. Observability considerations for multi-sensor and product fusion: Bias, information content, and validation (Invited)

    Science.gov (United States)

    Reid, J. S.; Zhang, J.; Hyer, E. J.; Campbell, J. R.; Christopher, S. A.; Ferrare, R. A.; Leptoukh, G. G.; Stackhouse, P. W.

    2009-12-01

    With the successful development of many aerosol products from the NASA A-train as well as new operational geostationary and polar orbiting sensors, the scientific community now has a host of new parameters to use in their analyses. The variety and quality of products has reached a point where the community has moved from basic observation-based science to sophisticated multi-component research that addresses the complex atmospheric environment. In order for these satellite data contribute to the science their uncertainty levels must move from semi-quantitative to quantitative. Initial attempts to quantify uncertainties have led to some recent debate in the community as to the efficacy of aerosol products from current and future NASA satellite sensors. In an effort to understand the state of satellite product fidelity, the Naval Research Laboratory and a newly reformed Global Energy and Water Cycle Experiment (GEWEX) aerosol panel have both initiated assessments of the nature of aerosol remote sensing uncertainty and bias. In this talk we go over areas of specific concern based on the authors’ experiences with the data, emphasizing the multi-sensor problem. We first enumerate potential biases, including retrieval, sampling/contextual, and cognitive bias. We show examples of how these biases can subsequently lead to the pitfalls of correlated/compensating errors, tautology, and confounding. The nature of bias is closely related to the information content of the sensor signal and its subsequent application to the derived aerosol quantity of interest (e.g., optical depth, flux, index of refraction, etc.). Consequently, purpose-specific validation methods must be employed, especially when generating multi-sensor products. Indeed, cloud and lower boundary condition biases in particular complicate the more typical methods of regressional bias elimination and histogram matching. We close with a discussion of sequestration of uncertainty in multi-sensor applications of

  16. Special forest products: integrating social, economic, and biological considerations into ecosystem management.

    Science.gov (United States)

    R. Molina; N. Vance; J.F. Weigand; D. Pilz; M.P. Amaranthus

    1997-01-01

    Throughout history, forests have provided a wealth of beneficial and essential products ranging from foods and medicines to building materials. Ancient pharmacopoeias list myriad forest plants and fungi for treating various ailments. Many of these ancient remedies have evolved and continue to evolve into the important drugs of modern medicine. Use of diverse forest...

  17. 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.

  18. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Science.gov (United States)

    2012-12-13

    ... error-prone label and packaging designs. Among these measures, FDA agreed that by the end of FY 2010... minimizing risks with the design of drug product container labels, carton labeling, and packaging... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1005...

  19. 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.

  20. 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.

  1. 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

  2. Barriers to knowledge production, knowledge translation, and urban health policy change: ideological, economic, and political considerations.

    Science.gov (United States)

    Muntaner, Carles; Chung, Haejoo; Murphy, Kelly; Ng, Edwin

    2012-12-01

    In this paper, we consider social forces that affect the processes of both knowledge production and knowledge translation in relation to urban health research. First, we briefly review our conceptual model, derived from a social-conflict framework, to outline how unequal power relations and health inequalities are causally linked. Second, we critically discuss ideological, political, and economic barriers that exist within academia that affect knowledge production related to urban health and health inequalities. Third, we broaden the scope of our analysis to examine how the ideological, political, and economic environment beyond the academy creates barriers to health equity policy making. We conclude with some key questions about the role that knowledge translation can possibly play in light of these constraints on research and policy for urban health.

  3. CONSIDERATIONS UPON DESIGNING MODULAR CONSTRUCTIONS FOR IMPROVING THE PRODUCTS ASSEMBLING, MAINTENANCE AND RECYCLING PROCESSES

    Directory of Open Access Journals (Sweden)

    BÂRSAN Lucian

    2015-11-01

    Full Text Available Modular constructions are frequently used in industry because of their multiple advantages. Used from the antiquity as a measuring system that ensured good proportions for the objects or buildings, the module is used in present industry as a tool for improving the product maintenance, repair, upgrading, and/or recycling. Modular constructions can be assembled and disassembled easily, facilitating the postuse actions like subassemblies reuse, or materials recovering for the recycling process. An important aspect of this paper is that designers should create the modular solution even from the conceptual design stage and build a structure of functions based on well motivated arguments and which can easily be brake out according to technological possibilities, product functioning and assembly solutions.

  4. CONSIDERATIONS REGARDING THE DESIGN OF SPECIFIC TOURISM PRODUCTS FOR THE TOURISM DESTINATION ROMANIA

    Directory of Open Access Journals (Sweden)

    MONICA PAULA RAŢIU

    2011-01-01

    Full Text Available Romania, as tourism destination with its component micro-destinations (Muntenia, Oltenia, Banat - Crişana, Transylvania, Bucovina, Maramureş, Moldavia and Dobrogea, possesses many tourism attractions and at the same time has a real tourism potential. The fact that it is not included among the Europe’s „valuable” destinations represents a loss both for its inhabitants and for Europeans in general, too. One of the reasons is the lack of an image consolidated by identity elements or / and simply the lack of image that would represent the starting point for development of appropriate tourism products (developing a strategy. This paper proposes, starting from the image perceived by the inhabitants about their own destination – based on the example of Transylvania – to emphasize the importance and also the role of the destination image in developing the main directions of actions and, especially, in developing the strategy for the specific tourism products.

  5. Solvent-free production of 1,3-diglyceride of CLA: Strategy consideration and protocol design

    DEFF Research Database (Denmark)

    Guo, Zheng; Sun, Yan

    2007-01-01

    of eliminating mass transfer resistance, creating effective interaction for a multiple-phase reaction system and yielding an efficient water removal and a faster reaction rate. Hence, vacuum-driven N2 stirring was considered as the best choice among the tested strategies for the production of pure 1......Enzymatic production of a homogeneous 1,3-diglyceride of polyunsaturated fatty acids (PUFAs) was carried out using Novozym 435 as biocatalyst and conjugated linoleic acid (CLA) as a model fatty acid. Three different operation modes, namely, magnetic stirring under vacuum, vacuum-driven N2 bubbling...... incubated with 10–12 mmol CLA for about 3 h at 45–55 °C and a pressure less than 10 mbar, with enzyme loading of 40–70 g l−1. Among the operational parameters, temperature and reaction time were found to have profound effects on the acylmigration and yield of 1,3-diglyceride. Moreover, the enzyme showed...

  6. 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...

  7. Collisional pumping for the production of intense spin-polarized neutral beams: target considerations. Revision

    International Nuclear Information System (INIS)

    Stearns, J.W.; Burrell, C.F.; Kaplan, S.N.; Pyle, R.V.; Ruby, L.; Schlachter, A.S.

    1985-04-01

    Polarized beams at intensity levels heretofore not considered feasible have recently been proposed for heating and fueling fusion plasmas. Polarized-beam fueling could increase fusion rates by 50% as well as allow control of the directionality of the fusion products. A process which we have recently described, and called collisional pumping, promises to produce beams of polarized ions vastly more intense than producible by current methods

  8. Considerations related to the deuterium-depleted water isotopic analysis for an industrial production pilot plant

    International Nuclear Information System (INIS)

    Varlam, Mihai; Steflea, Dumitru; Irimescu, Rodica

    2000-01-01

    In the last few years, there is a major interest related to the use of Deuterium Depleted Water (DDW) for biological and medical purposes. Therefore, a production installation for DDW was developed and now, it is working in our Institute. The deuterium isotopic concentration for the final product is in the 10 - 40 ppm D / (D + H) range depending on customers' requirements. In order to control and manage the production process and also to validate the final product, a special procedure for deuterium content measurement for DDW by Isotopic Ratio Mass Spectrometry was developed. The main instrumentation is a MAT 250 IRMS with a hydrogen preparation line based on the zinc reduction process. The first concern regarding the analysis procedure for these water samples with very low deuterium concentration has been related to the preparation of an internal standard with a D / (D + H) isotopic value in the measurement range. For this raison, a distinct procedure was developed and applied, so that starting to the well-known VSMOW standard and so, a sequence of 12 samples with decreasing deuterium content was obtained. These samples were measured and 3 / 2 ratio mass signals versus 2 mass signal were plotted and statistically analyzed. Obviously, for each measurement, a H 3+ correction factor was calculated and applied, as a results of an entire statistically elimination procedure and by extrapolation of the linear curve plotted, a value for the primary DDW was determined. Other important problem related to deuterium content determination was to minimize the H 3+ factor correction. As the deuterium content is very low the contribution of this factor to the 3 mass signal becomes very important. Therefore, special operations were developed, considering the behaviour of linear dependence between 3 / 2 mass signal versus 2 mass signal in the lower part. Finally, special attention was given to estimate the lower isotopic concentration analysis limit. (authors)

  9. A Solution-Based Approach for Mo-99 Production: Considerations for Nitrate versus Sulfate Media

    Directory of Open Access Journals (Sweden)

    Amanda J. Youker

    2013-01-01

    Full Text Available Molybdenum-99 is the parent of Technetium-99m, which is used in nearly 80% of all nuclear medicine procedures. The medical community has been plagued by Mo-99 shortages due to aging reactors, such as the NRU (National Research Universal reactor in Canada. There are currently no US producers of Mo-99, and NRU is scheduled for shutdown in 2016, which means that another Mo-99 shortage is imminent unless a potential domestic Mo-99 producer fills the void. Argonne National Laboratory is assisting two potential domestic suppliers of Mo-99 by examining the effects of a uranyl nitrate versus a uranyl sulfate target solution configuration on Mo-99 production. Uranyl nitrate solutions are easier to prepare and do not generate detectable amounts of peroxide upon irradiation, but a high radiation field can lead to a large increase in pH, which can lead to the precipitation of fission products and uranyl hydroxides. Uranyl sulfate solutions are more difficult to prepare, and enough peroxide is generated during irradiation to cause precipitation of uranyl peroxide, but this can be prevented by adding a catalyst to the solution. A titania sorbent can be used to recover Mo-99 from a highly concentrated uranyl nitrate or uranyl sulfate solution; however, different approaches must be taken to prevent precipitation during Mo-99 production.

  10. A compositional multiphase model for groundwater contamination by petroleum products: 1. Theoretical considerations

    Science.gov (United States)

    Corapcioglu, M. Yavuz; Baehr, Arthur L.

    1987-01-01

    A mathematical model is developed to describe the fate of hydrocarbon constituents of petroleum products introduced to soils as an immiscible liquid from sources such as leaking underground storage tanks and ruptured pipelines. The problem is one of multiphase transport (oil (immiscible), air, and water phases) of a reactive contaminant with constituents such as benzene, toluene, and xylene found in refined petroleum products like gasoline. In the unsaturated zone, transport of each constituent can occur as a solute in the water phase, vapor in the air phase, and as an unaltered constituent in the oil phase. Additionally, the model allows for adsorption. Molecular transformations, microbially mediated or abiotic, are incorporated as sink terms in the conservation of mass equations. An equilibrium approximation, applicable to any immiscible organic contaminant is applied to partition constituent mass between the air, oil, water, and adsorbed phases for points in the region where the oil phase exists. Outside the oil plume the equilibrium approximation takes on a simpler form to partition constituent mass between the air, water, and adsorbed phases only. Microbial degradation of petroleum products is first discussed in a general model, then the conservation of mass equation for oxygen is incorporated into the analysis which takes advantage of the key role played by oxygen in the metabolism of hydrocarbon utilizing microbes in soil environments. Approximations to two subproblems, oil plume establishment in the unsaturated zone, and solute and vapor transport subsequent to immiscible plume establishment are then developed from the general model.

  11. RF system considerations for accelerator production of tritium and the transmutation of nuclear waste

    International Nuclear Information System (INIS)

    Tallerico, P.J.; Lynch, M.T.

    1993-01-01

    RF driven proton accelerators for the transmutation of nuclear waste (ATW) or for the production of tritium (APT) require unprecedented amounts of CW RF power at UHF frequencies. For both systems, the baseline design is for 246 MW at 700 MHz and 8,5 MW at 350 MHz. The main technical challenges are how to design and build such a large system so that it has excellent reliability, high efficiency, and reasonable capital cost. The issues associated with the selection of the RF amplifier and the sizes of the power supplies are emphasized in this paper

  12. Product platform considerations on a project that develops sustainable low-cost housing for townships

    DEFF Research Database (Denmark)

    Wörösch, Michael; Bonev, Martin; Mortensen, Niels Henrik

    Construction companies in Denmark are often working with profit margins as little as 1-3% in situations where they deliver high-end buildings to the local market. Even though customers are willing to pay a premium price for high quality, construction companies earn very little on their products...... their new owners the possibility to take a loan in their building which is expected to contribute to more businesses being started up and thereby strengthening the domestic economy. As a consequence of this, additional research is needed in how to further optimize the economy of sustainable low-cost housing...

  13. Considerations in the design of a high power medical isotope production reactor

    International Nuclear Information System (INIS)

    Ball, Russell M.; Nordyke, William H.; Brown, Roy

    2002-01-01

    For the low enriched aqueous homogeneous reactor to be economic in the production of medical isotopes, such as Mo-99 and Sr-89, the power level should be of the order of 100 kWth. This is double the earlier designs and this paper discusses the design changes which must be considered to meet this goal. The topics considered are: 1. Heat removal from the reactor solution; 2. Recombination of radiolytic gases; 3. Adequate radiation shielding; 4. Stability of reactor power with fluctuating reactivity; 5. Adequate cooling of the reflector; 6. Independent shutdown mechanisms; 7. Required volume of the reactor; 8. Economic implementation. (author)

  14. Considerations on post-production obligations in terms of Atomic Energy Law

    International Nuclear Information System (INIS)

    Rebentisch, M.

    1992-01-01

    The article describes and evaluates the laws concerning the decommissioning and dismantling of nuclear power plants and offers suggestions for possible new regulations. The contribution examines fundamental legal aspects, the instrumentalization of post-production obligations in terms of atomic energy laws, especially the question as to how to bring the Atomic Energy Law into accord with the Federal Emission Control Law within the realm of decommissioning laws, licences for safe confinement and dismantling of a plant, and in addition questions on making financial provisions for decommissioning. (orig./HSCH) [de

  15. Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.

    Science.gov (United States)

    Halioua-Haubold, Celine-Lea; Peyer, James G; Smith, James A; Arshad, Zeeshaan; Scholz, Matthew; Brindley, David A; MacLaren, Robert E

    2017-12-01

    Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs fall in the United States, the European Union, and Japan, and a comprehensive overview of the regulatory guidance applicable to the developer of GTP. Understanding the regulatory requirements for seeking GTP market approval in these major jurisdictions is crucial for an effective and expedient path to market. The novel challenges facing GTP developers is highlighted by a case study of alipogene tiparvovec (Glybera).

  16. Voluntary Certification of Agricultural Products in Competitive Markets: The Consideration of Boundedly Rational Consumers

    Directory of Open Access Journals (Sweden)

    Xujin Pu

    2016-09-01

    Full Text Available Market competition creates strategic incentives for firms to communicate private information about their own product quality through certification. Although voluntary certification has recently gained importance in the agricultural industry, information asymmetry is not always completely addressed. This study analyzes how the relative proportion of boundedly rational consumers in the market influences the effectiveness of voluntary certification mechanisms by using a duopoly game model of high- and low-quality firms. The presented results show that a change in the proportion of boundedly rational consumers leads to different certification behaviors and a different market equilibrium. We also find that the existence of boundedly rational consumers is an important factor in the failure of voluntary certification. Indeed, when the relative proportion of such consumers is very high, voluntary certification is ineffective at improving market efficiency.

  17. FMEA and consideration of real work situations for safer design of production systems.

    Science.gov (United States)

    Lux, Aurélien; Mawo De Bikond, Johann; Etienne, Alain; Quillerou-Grivot, Edwige

    2016-12-01

    Production equipment designers must ensure the health and safety of future users; in this regard, they augment requirements for standardizing and controlling operator work. This contrasts with the ergonomic view of the activity, which recommends leaving operators leeway (margins for manoeuvre) in performing their task, while safeguarding their health. Following a brief analysis of design practices in the car industry, we detail how the Failure Modes and Effects Analysis (FMEA) approach is implemented in this sector. We then suggest an adaptation that enables designers to consider real work situations. This new protocol, namely, work situation FMEA, allows experience feedback to be used to defend the health standpoint during designer project reviews, which usually only address quality and performance issues. We subsequently illustrate the advantage of this approach using two examples of work situations at car parts manufacturers: the first from the literature and the second from an in-company industrial project.

  18. Some ecological and socio-economic considerations for biomass energy crop production

    International Nuclear Information System (INIS)

    Paine, L.K.; Undersander, D.J.; Temple, S.A.; Klemme, R.M.; Peterson, T.L.; Bartelt, G.A.; Sample, D.W.; Rineer, K.C.

    1996-01-01

    The purpose of this paper is to suggest a regional approach to ensure that energy crop production will proceed in an ecologically and economically sustainable way. At this juncture, we have the opportunity to build into the system some ecological and socio-economic values which have not traditionally been considered. If crop species are chosen and sited properly, incorporation of energy crops into our agricultural system could provide extensive wildlife habitat and address soil and water quality concerns, in addition to generating renewable power. We recommend that three types of agricultural land be targeted for perennial biomass energy crops: (1) highly erodible land; (2) wetlands presently converted to agricultural uses; and (3) marginal agricultural land in selected regions. Fitting appropriate species to these lands, biomass crops can be successfully grown on lands not ecologically suited for conventional farming practices, thus providing an environmental benefit in addition to producing an economic return to the land owner. (author)

  19. Facility design consideration for continuous mix production of class 1.3 propellant

    Science.gov (United States)

    Williamson, K. L.; Schirk, P. G.

    1994-01-01

    In November of 1989, NASA awarded the Advanced Solid Rocket Motor (ASRM) contract to Lockheed Missiles and Space Company (LMSC) for production of advanced solid rocket motors using the continuous mix process. Aerojet ASRM division (AAD) was selected as the facility operator and RUST International Corporation provided the engineering, procurement, and construction management services. The continuous mix process mandates that the mix and cast facilities be 'close-coupled' along with the premix facilities, creating unique and challenging requirements for the facility designer. The classical approach to handling energetic materials-division into manageable quantities, segregation, and isolation-was not available due to these process requirements and quantities involved. This paper provides a description of the physical facilities, the continuous mix process, and discusses the monitoring and detection techniques used to mitigate hazards and prevent an incident.

  20. Consideration on developing of leaked inflammable gas detection system for HTGR hydrogen production system

    International Nuclear Information System (INIS)

    Nishihara, Tetsuo; Nakamura, Masashi

    1999-09-01

    One of most important safety design issues for High Temperature Gas-cooled Reactor (HTGR) - Hydrogen Production System (HTGR-HPS) is to ensure reactor safety against fire and explosion at the hydrogen production plant. The inflammable gas mixture in the HTGR-HPS does not use oxygen in any condition and are kept in high pressure in the normal operation. The piping system and/or heat transfer tubes which have the potential possibility of combustible materials ingress into the Reactor Building (R/B) due to the failure are designed to prevent the failure against any events. Then, it is not necessary to consider their self-combustion in vessels nor leakage in the R/B. The only one case which we must consider is the ex-building fire or explosion caused by their leakage from piping or vessel. And it is important to mitigate their effects by means of early detection of gas leakage. We investigated our domestic standards on gas detection, applications of gas detectors, their detection principles, performance, sensitivity, reliability, their technical trends, and so on. We proposed three gas detection systems which may be applied in HTGR-HPS. The first one is the universal solid sensor system; it may be applied when there is no necessity to request their safety credits. The second is the combination of the improved solid sensor system and enhanced beam detector system; it may be applied when it is necessary to request their safety credit. And the third is the combination of the universal solid sensor system and the existing beam detector system; it may be applied when the plant owner request higher detector sensitivity than usual, from the view point of public acceptance, though there is not necessity to request their safety credits. To reduce the plant cost by refusing of safety credits to the gas leakage detection system, we proposed that the equipment required to isolate from others should be installed in the inertrized compartments. (author)

  1. Considerations in modelling the melting of fuel containing fission products and solute oxides

    International Nuclear Information System (INIS)

    Akbari, F.; Welland, M.J.; Lewis, B.J.; Thompson, W.T.

    2005-01-01

    It is well known that the oxidation of a defected fuel element by steam gives rise to an increase in O/U ratio with a consequent lowering of the incipient melting temperature. Concurrently, the hyperstoichiometry reduces the thermal conductivity thereby raising the centerline fuel pellet temperature for a fixed linear power. The development of fission products soluble in the UO 2 phase or, more important, the deliberate introduction of additive oxides in advanced CANDU fuel bundle designs further affects and generally lowers the incipient melting temperature. For these reasons, the modeling of the molten (hyperstoichiometric) UO 2 phase containing several solute oxides (ZrO 2 , Ln 2 O 3 and AnO 2 ) is advancing in the expectation of developing a moving boundary heat and mass transfer model aimed at better defining the limits of safe operating practice as burnup advances. The paper describes how the molten phase stability model is constructed. The redistribution of components across the solid-liquid interface that attends the onset of melting of a non-stoichiometric UO 2 containing several solutes will be discussed. The issues of how to introduce boundary conditions into heat transfer calculations consistent with the requirements of the Phase Rule will be addressed. The Stefan problem of a moving boundary associated with the solid/liquid interface sets this treatment apart from conventional heat and mass transfer problems. (author)

  2. 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.

  3. 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

  4. 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...

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. "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.

  10. 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...

  11. Translational Radiomics: Defining the Strategy Pipeline and Considerations for Application-Part 2: From Clinical Implementation to Enterprise.

    Science.gov (United States)

    Shaikh, Faiq; Franc, Benjamin; Allen, Erastus; Sala, Evis; Awan, Omer; Hendrata, Kenneth; Halabi, Safwan; Mohiuddin, Sohaib; Malik, Sana; Hadley, Dexter; Shrestha, Rasu

    2018-03-01

    Enterprise imaging has channeled various technological innovations to the field of clinical radiology, ranging from advanced imaging equipment and postacquisition iterative reconstruction tools to image analysis and computer-aided detection tools. More recently, the advancement in the field of quantitative image analysis coupled with machine learning-based data analytics, classification, and integration has ushered in the era of radiomics, a paradigm shift that holds tremendous potential in clinical decision support as well as drug discovery. However, there are important issues to consider to incorporate radiomics into a clinically applicable system and a commercially viable solution. In this two-part series, we offer insights into the development of the translational pipeline for radiomics from methodology to clinical implementation (Part 1) and from that point to enterprise development (Part 2). In Part 2 of this two-part series, we study the components of the strategy pipeline, from clinical implementation to building enterprise solutions. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  12. [Quantifying the additional clinical benefit of new medicines: little - considerable - significant - 6 remarks from a biometrician's point of view].

    Science.gov (United States)

    Vach, Werner

    2014-11-01

    According to the German Pharmaceutical Market Reorganisation Act [Arzneimittelmarktneuordnungsgesetz (AMNOG)] of 22.12.2010, the benefit assessment of a new drug should include an evaluation of the "degree of additional benefit". A corresponding regulation of the German Ministry of Health states that the quantification of the degree of additional benefit should be made in the terms "major additional benefit", "considerable additional benefit" and "little additional benefit". In September 2011 the IQWiG undertook and explained in appendix A of the dossier evaluation of Ticagrelor an "operationalisation of the extent of additional benefit according to AM-NutzenV". Therein a distinction was made between the target categories "survival time (mortality)", "serious (or, respectively, severe) symptoms", "quality of life", and "not serious (or, respectively, not severe) symptoms". In the operationalisation of the IQWiG, the categorisation of the additional benefit with regard to mortality was addressed by definition of threshold values for the upper limit of the 95% confidence interval for the relative risk (RR). The statutory regulations and the operationalisation of the IQWiG will have direct long-term effects on the provision of medical care since they have a say as to which drugs are to be available at which prices. By introduction of terms such as "major additional benefit", "considerable additional benefit" or "desired effects" and linking them to statistical parameters and algorithms, they also open a series of further fundamental questions as to if and how we should handle these terms in the future and what consequences are inherent to the use of statistical criteria in their "definition". In the present article 6 of the questions that arise in this context are discussed: Can a "considerable additional benefit" be defined with statistical methods? Can a classification of the additional benefit on the basis of an estimated RR be reliable? What are the fundamental

  13. Duplication of complete dentures using general-purpose handheld optical scanner and 3-dimensional printer: Introduction and clinical considerations.

    Science.gov (United States)

    Kurahashi, Kosuke; Matsuda, Takashi; Goto, Takaharu; Ishida, Yuichi; Ito, Teruaki; Ichikawa, Tetsuo

    2017-01-01

    To introduce a new clinical procedure for fabricating duplicates of complete dentures by bite pressure impression using digital technology, and to discuss its clinical significance. The denture is placed on a rotary table and the 3-dimensional form of the denture is digitized using a general-purpose handheld optical scanner. The duplicate denture is made of polylactic acid by a 3-dimensional printer using the 3-dimensional data. This procedure has the advantages of wasting less material, employing less human power, decreasing treatment time at the chair side, lowering the rates of contamination, and being readily fabricated at the time of the treatment visit. Copyright © 2016 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

  14. Clinical Aspects, Imaging Features, and Considerations on Bisphosphonate-Related Osteonecrosis Risk in a Pediatric Patient with Osteogenesis Imperfecta

    Directory of Open Access Journals (Sweden)

    Fábio Wildson Gurgel Costa

    2014-01-01

    Full Text Available Osteogenesis imperfecta (OI is a rare hereditary condition caused by changes in collagen metabolism. It is classified into four types according to clinical, genetic, and radiological criteria. Clinically, bone fragility, short stature, blue sclerae, and locomotion difficulties may be observed in this disease. OI is often associated to severe dental problems, such as dentinogenesis imperfecta (DI and malocclusions. Radiographically, affected teeth may have crowns with bulbous appearance, accentuated constriction in the cementoenamel junction, narrowed roots, large root canals due to defective dentin formation, and taurodontism (enlarged pulp chambers. There is no definitive cure, but bisphosphonate therapy is reported to improve bone quality; however, there is a potential risk of bisphosphonate-related osteonecrosis of the jaw. In this study we report a case of OI in a male pediatric patient with no family history of OI who was receiving ongoing treatment with intravenous perfusion of bisphosphonate and who required dental surgery. In addition, we discussed the clinical and imaging findings and briefly reviewed the literature.

  15. Practical considerations on the introduction of sacubitril/valsartan in clinical practice: Current evidence and early experience.

    Science.gov (United States)

    Farmakis, Dimitrios; Bistola, Vassiliki; Karavidas, Apostolos; Parissis, John

    2016-11-15

    The combination of neprilysin inhibitor sacubitril with the angiotensin II receptor 1 blocker valsartan is the first agent from the angiotensin receptor neprilysin inhibitors (ARNI) class authorized for clinical use in heart failure (HF) patients with reduced ejection fraction (HFrEF). Sacubitril/valsartan resulted in 20% reduction in the incidence rate of death or HF hospitalization compared to enalapril in symptomatic HFrEF patients in the seminal PARADIGM-HF trial. As a result, the recently updated European and American HF guidelines granted this agent a class IB indication for the treatment of ambulatory/chronic symptomatic HFrEF patients. However, translating the positive results of trials into true clinical benefit is often challenging. This is particularly true in the case of sacubitril/valsartan, as HF is a heterogeneous syndrome including many severely ill patients who are prone to decompensation, while this new agent comes to replace a cornerstone of current evidence-based HF therapy. In the present paper, we address a number of practical issues regarding the introduction of sacubitril/valsartan and propose an algorithm based on available evidence and early clinical experience. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. Stem cell-based treatments against stroke: observations from human proof-of-concept studies and considerations regarding clinical applicability

    Directory of Open Access Journals (Sweden)

    Thorsten Roland Doeppner

    2014-10-01

    Full Text Available Ischemic stroke remains a heavy burden for industrialized countries. The only causal therapy is the recanalization of occluded vessels via thrombolysis, which due to a narrow time window still can be offered only to a minority of patients. Since the majority of patients continues to exhibit neurological deficits even following successful thrombolysis, restorative therapies are urgently needed that promote brain remodeling and repair once stroke injury has occurred. Due to their unique properties of action, stem cell-based strategies gained increasing interest during recent years. Using various stroke models in both rodents and primates, the transplantation of stem cells, namely of bone marrow derived mesenchymal stem cells (MSCs or neural progenitor cells (NPCs, has been shown to promote neurological recovery most likely via indirect bystander actions. In view of promising observations, clinical proof-of-concept studies are currently under way, in which effects of stem and precursor cells are evaluated in human stroke patients. In this review we summarize already published studies, which due to the broad experience in other medical contexts mostly employed bone marrow-derived MSCs by means of intravenous transplantation. With the overall number of clinical trials limited in number, only a fraction of these studies used non-treated control groups, and only single studies were adequately blinded. Despite these limitations, first promising results justify the need for more elaborate clinical trials in order to make stem cell transplantation a success for stroke treatment in the future.

  17. ECAT ART - a continuously rotating PET camera: performance characteristics, initial clinical studies, and installation considerations in a nuclear medicine department

    International Nuclear Information System (INIS)

    Bailey, D.L.; Young, H.; Bloomfield, P.M.; Meikle, S.R.; Glass, D.; Myers, M.J.; Spinks, T.J.; Watson, C.C.; Luk, P.; Peters, A.M.; Jones, T.

    1997-01-01

    Advances in image reconstruction techniques have permitted the development of a commercial, rotating, partial ring, fully 3D scanner, the ECAT ART. The system has less than one-half the number of bismuth germanate detectors compared with a full ring scanner with the equivalent field of view, resulting in reduced capital cost. The performance characteristics, implications for installation in a nuclear medicine department, and clinical utility of the scanner are presented in this report. The sensitivity (20 cm diameter x 20 cm long cylindrical phantom, no scatter correction) is 11400 cps.kBq -1 .ml -1 . This compares with 5800 and 40500 cps.kBq -1 .ml -1 in 2D and 3D respectively for the equivalent full ring scanner (ECAT EXACT). With an energy window of 350-650 keV the maximum noise equivalent count (NEC) rate was 27 kcps at a radioactivity concentration of ∝15 kBq .ml -1 in the cylinder. Spatial resolution is ∝6 mm full width at half maximum on axis degrading to just under 8 mm at a distance of 20 cm off axis. Installation and use within the nuclear medicine department does not appreciably increase background levels of radiation on gamma cameras in adjacent rooms and the dose rate to an operator in the same room is 2 μSv .h -1 for a typical fluorine-18 fluorodeoxyglucose ( 18 F-FDG) study with an initial injected activity of 370 MBq. The scanner has been used for clinical imaging with 18 F-FDG for neurological and oncological applications. Its novel use for imaging iron-52 transferrin for localising erythropoietic activity demonstrates its sensitivity and resolution advantages over a conventional dual-headed gamma camera. The ECAT ART provides a viable alternative to conventional full ring PET scanners without compromising the performance required for clinical PET imaging. (orig.). With 9 figs., 3 tabs

  18. What, why, and when we image: considerations for diagnostic imaging and clinical research in the Children's Oncology Group

    International Nuclear Information System (INIS)

    Reaman, Gregory H.

    2009-01-01

    Success in improving treatment outcomes in childhood cancer has been achieved almost exclusively through multicenter and multidisciplinary clinical and applied research over several decades. While biologically rational as well as empirical approaches have led to combination chemotherapy and multimodality approaches to therapy, which have given rise to evidence-based practice standards, similar scientific rigor has not always been as evidently applied to modalities utilized to assess initial disease burden and, more important, response to investigational approaches to therapy. As the empirical approach to therapeutic advances has likely maximized its benefit, future progress will require translation of biologic discovery most notably from the areas of genomics and proteomics. Hence, attempts to improve efficacy of therapy will require a parallel effort to minimize collateral damage of future therapeutic approaches, and such a parallel approach will mandate the continued dependence on advances in diagnostic imaging for improvements in staging methodologies to best define risk groups for risk-adjusted therapy. In addition, anatomic and functional assessment of response and surveillance for disease recurrence will require improved understanding of the biology as well as natural history of individual diseases, which one hopes will better inform investigators in designing trials. Clinical and research expertise is urgently needed in the selection of specific imaging studies and frequencies that best assess a response as well as to define disease-free intervals. Despite limited resources to develop sufficient infrastructure, emphasis on enabling early assessment of new technology to minimize risks associated with treatment advances and with those critical diagnostic and staging procedures must continue to be a focus of pediatric cancer clinical research. (orig.)

  19. Clinical social work practice and technology: personal, practical, regulatory, and ethical considerations for the twenty-first century.

    Science.gov (United States)

    Dombo, Eileen A; Kays, Lisa; Weller, Katelyn

    2014-10-01

    The world that social work exists in is no longer defined by traditional physical settings and boundaries, such as schools, agencies, or even offices. With the advent of the Internet and digital communications, social work now exists in a far more complex reality, with clients and social workers engaging across multiple platforms, and sometimes even unintentionally and without one another's awareness. The implications of this can be ethical, practical, regulatory, and personal. This article explores these areas of concern and suggests strategies professionals can use to navigate these complex issues related to technology and clinical practice.

  20. 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

  1. A review of clinical and technical considerations for fixed and removable implant prostheses in the edentulous mandible.

    Science.gov (United States)

    Zitzmann, Nicola Ursula; Marinello, Carlo Paolo

    2002-01-01

    The aim of the present article is to review some of the technical treatment options for implant prostheses restoring the edentulous mandible, mainly based on the Brånemark system. Clinical and technical aspects are discussed for the three established concepts: (1) implant-supported fixed prosthesis, (2) removable implant-supported overdenture, and (3) combined implant-retained and soft tissue-supported overdenture prosthesis. The framework of an implant-supported fixed screw-retained prosthesis can be processed in gold, Co-Cr alloy, or titanium with casting, laser-welding, or milling techniques. To improve the stability and retention of a conventional complete denture, one to four implants are indicated, and unsplinted (single attachments) or splinted designs (bar systems) can be applied. The design of the overdenture prosthesis must be carefully planned according to the requirements to ensure adequate stability and optimal form, contour, and esthetics, and the patient's best comfort. A large variety of different treatment modalities exist for both the fixed and removable mandibular implant prosthesis. Clinical and technical aspects should be considered at the beginning of the treatment to: (1) select the optimal implant position, (2) establish an adequate number of functional units, (3) select the appropriate retainers, and (4) apply the best technique for framework processing and veneering.

  2. Clinical utility and patient considerations in the use of the sitagliptin-metformin combination in Chinese patients

    Directory of Open Access Journals (Sweden)

    Du Q

    2015-02-01

    Full Text Available Qiang Du, Yan-Jun Wang, Sheng Yang, Ping HanDepartment of Endocrinology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People’s Republic of ChinaAbstract: The prevalence of diabetes mellitus (DM continues to increase each year. However, the efficacy of glucose-lowering therapies remains unsatisfactory. Moreover, the clinical characteristics and manifestations of DM in Chinese patients are different from those in Western patients. Thus, it is imperative to develop an optimal treatment protocol for lowering blood glucose levels in Chinese patients with DM. Sitagliptin has been used in People’s Republic of China, and sitagliptin and metformin combination therapy may not alter their individual pharmacokinetics. To date, several clinical trials undertaken to investigate the efficacy of sitagliptin and metformin combination therapy have revealed that it effectively controlled glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose levels to a greater extent than sitagliptin or metformin alone. In addition, the combined therapy was well tolerated and induced few side effects, which were largely mild. Furthermore, the combined therapy was easy to administer, and the patients receiving this therapy showed good compliance. Therefore, for Chinese patients with type 2 DM, sitagliptin and metformin combination therapy is preferred.Keywords: type 2 diabetes mellitus, sitagliptin, metformin

  3. Bone scintigraphy in bone stress. A technical consideration and correlation of the findings to clinical symptoms especially to the pain

    International Nuclear Information System (INIS)

    Kuusela, T.; Vorne, M.; Vahatalo, S.

    1983-01-01

    The purpose of this investigation was to find out a reliable scintigraphic method to investigate different fatigue phenomena in bone and to correlate the scintigraphic findings to the development of clinical symptoms. The gamma-imaging after the injection of bone seeking tracers is recommended to be performed after a period of 1-3 hours. The experiments indicate that in active bone tissue, might it be a healing fracture or a remodeling bone, the tracer uptake still increases after 1-3 hours. The delayed gamma-imaging can therefore be useful, especially if it is important to investigate faint physiological changes in bone tissue. It seems, that the capacity of emission energy in the diagnosis of bone affections is superior to the radiology because of its excellent histo-functional resolution especially in detecting and localizing bone affections

  4. Rapid detection of methicillin-resistant Staphylococcus aureus directly from clinical samples: methods, effectiveness and cost considerations

    Directory of Open Access Journals (Sweden)

    Stürenburg, Enno

    2009-07-01

    Full Text Available Methicillin-resistant Staphylococcus aureus (MRSA isolates is a serious public health problem whose ever-increasing rate is commensurate with the pressure it is exerting on the healthcare system. At present, more than 20% of clinical S. aureus isolates in German hospitals are methicillin resistant. Strategies from low-prevalence countries show that this development is not necessarily inevitable. In the Scandinavian countries and the Netherlands, thanks to a rigorous prevention programme, MRSA prevalence has been kept at an acceptably low level (<1–3%. Central to these ‘search and destroy’ control strategies is an admission screening using several MRSA swabs taken from mucocutaneous colonisation sites of high-risk patients (‘MRSA surveillance’. It has also been reported that the speed with which MRSA carriage is detected has an important role to play, as it is a key component of any effective strategy to prevent the pathogen from spreading. Since MRSA culturing involves a 2–3 day delay before the final results are available, rapid detection techniques (commonly referred to as ‘MRSA rapid tests’ using PCR methods and, most recently, rapid culturing methods have been developed. The implementation of rapid tests reduces the time of detection of MRSA carriers from 48–72 to 2–5 h. Clinical evaluation data have shown that MRSA can thus be detected with very high sensitivity. Specificity however is sometimes impaired due to false-positive PCR signals occurring in mixed flora specimens. In order to rule out any false-positive PCR results, a culture screen must always be carried out simultaneously.The data provide preliminary evidence that a PCR assay can reduce nosocomial MRSA transmission in high-risk patients or high-risk areas, whereas an approach that screens all patients admitted to the hospital is probably not effective. Information concerning the cost-effectiveness of rapid MRSA tests is still sparse and thus the issue remains

  5. 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.

  6. 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.

  7. 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.

  8. 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...

  9. 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

  10. Scatter radiation intensities around a clinical digital breast tomosynthesis unit and the impact on radiation shielding considerations

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Kai, E-mail: kyang11@mgh.harvard.edu; Li, Xinhua; Liu, Bob [Division of Diagnostic Imaging Physics, Department of Radiology, Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts 02114 (United States)

    2016-03-15

    Purpose: To measure the scattered radiation intensity around a clinical digital breast tomosynthesis (DBT) unit and to provide updated data for radiation shielding design for DBT systems with tungsten-anode x-ray tubes. Methods: The continuous distribution of scattered x-rays from a clinical DBT system (Hologic Selenia Dimensions) was measured within an angular range of 0°–180° using a linear-array x-ray detector (X-Scan 0.8f3-512, Detection Technology, Inc., Finland), which was calibrated for the x-ray spectrum range of the DBT unit. The effects of x-ray field size, phantom size, and x-ray kVp/filter combination were investigated. Following a previously developed methodology by Simpkin, scatter fraction was determined for the DBT system as a function of angle around the phantom center. Detailed calculations of the scatter intensity from a DBT system were demonstrated using the measured scatter fraction data. Results: For the 30 and 35 kVp acquisition, the scatter-to-primary-ratio and scatter fraction data closely matched with data previously measured by Simpkin. However, the measured data from this study demonstrated the nonisotropic distribution of the scattered radiation around a DBT system, with two strong peaks around 25° and 160°. The majority scatter radiation (>70%) originated from the imaging detector assembly, instead of the phantom. With a workload from a previous survey performed at MGH, the scatter air kerma at 1 m from the phantom center for wall/door is 1.76 × 10{sup −2} mGy patient{sup −1}, for floor is 1.64 × 10{sup −1} mGy patient{sup −1}, and for ceiling is 3.66 × 10{sup −2} mGy patient{sup −1}. Conclusions: Comparing to previously measured data for mammographic systems, the scatter air kerma from Holgoic DBT is at least two times higher. The main reasons include the harder primary beam with higher workload (measured with total mAs/week), added tomosynthesis acquisition, and strong small angle forward scattering. Due to the

  11. Immunization in pregnancy clinical research in low- and middle-income countries - Study design, regulatory and safety considerations.

    Science.gov (United States)

    Kochhar, Sonali; Bonhoeffer, Jan; Jones, Christine E; Muñoz, Flor M; Honrado, Angel; Bauwens, Jorgen; Sobanjo-Ter Meulen, Ajoke; Hirschfeld, Steven

    2017-12-04

    Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers and their infants. Establishing safety and efficacy of vaccines generally uses a hybrid design between a conventional interventional study and an observational study that requires enrolling thousands of study participants to detect an unknown number of uncommon events. Historically, enrollment of pregnant women in clinical research studies encountered many barriers based on risk aversion, lack of knowledge, and regulatory ambiguity. Conducting research enrolling pregnant women in low- and middle-income countries can have additional factors to address such as limited availability of baseline epidemiologic data on disease burden and maternal and neonatal outcomes during and after pregnancy; challenges in recruiting and retaining pregnant women in research studies, variability in applying and interpreting assessment methods, and variability in locally acceptable and available infrastructure. Some measures to address these challenges include adjustment of study design, tailoring recruitment, consent process, retention strategies, operational and logistical processes, and the use of definitions and data collection methods that will align with efforts globally. Copyright © 2017. Published by Elsevier Ltd.

  12. Measurement error, time lag, unmeasured confounding: Considerations for longitudinal estimation of the effect of a mediator in randomised clinical trials.

    Science.gov (United States)

    Goldsmith, K A; Chalder, T; White, P D; Sharpe, M; Pickles, A

    2018-06-01

    Clinical trials are expensive and time-consuming and so should also be used to study how treatments work, allowing for the evaluation of theoretical treatment models and refinement and improvement of treatments. These treatment processes can be studied using mediation analysis. Randomised treatment makes some of the assumptions of mediation models plausible, but the mediator-outcome relationship could remain subject to bias. In addition, mediation is assumed to be a temporally ordered longitudinal process, but estimation in most mediation studies to date has been cross-sectional and unable to explore this assumption. This study used longitudinal structural equation modelling of mediator and outcome measurements from the PACE trial of rehabilitative treatments for chronic fatigue syndrome (ISRCTN 54285094) to address these issues. In particular, autoregressive and simplex models were used to study measurement error in the mediator, different time lags in the mediator-outcome relationship, unmeasured confounding of the mediator and outcome, and the assumption of a constant mediator-outcome relationship over time. Results showed that allowing for measurement error and unmeasured confounding were important. Contemporaneous rather than lagged mediator-outcome effects were more consistent with the data, possibly due to the wide spacing of measurements. Assuming a constant mediator-outcome relationship over time increased precision.

  13. Launching a new food product or dietary supplement in the United States: industrial, regulatory, and nutritional considerations.

    Science.gov (United States)

    Finley, John Weldon; Finley, John Wescott; Ellwood, Kathleen; Hoadley, James

    2014-01-01

    Launching a new food/dietary supplement into the US market can be a confusing process to those unfamiliar with the food industry. Industry capability and product specifications are initial determinants of whether a candidate product can be manufactured in a reproducible manner and whether pilot production can be brought up to the market scale. Regulatory issues determine how a product can be produced and marketed; the primary federal institutions involved in regulations are the US Department of Agriculture, the Food and Drug Administration, and the Federal Trade Commission. A primary distinction is made between food and drugs, and no product may enter the food market if it is in part or whole a drug. Product safety is a major concern, and myriad regulations govern the determination of safety. New foods/dietary supplements are often marketed by health claims or structure/function claims, and there are specific regulations pertaining to claims. Not understanding the regulatory issues involved in developing a new product or failing to comply with associated regulations can have legal and financial repercussions.

  14. Ready-to-use foods for management of moderate acute malnutrition: considerations for scaling up production and use in programs.

    Science.gov (United States)

    Osendarp, Saskia; Rogers, Beatrice; Ryan, Kelsey; Manary, Mark; Akomo, Peter; Bahwere, Paluku; Belete, Hilina; Zeilani, Mamane; Islam, Munirul; Dibari, Filippo; De Pee, Saskia

    2015-03-01

    Ready-to-use foods are one of the available strategies for the treatment of moderate acute malnutrition (MAM), but challenges remain in the use of these products in programs at scale. This paper focuses on two challenges: the need for cheaper formulations using locally available ingredients that are processed in a safe, reliable, and financially sustainable local production facility; and the effective use of these products in large-scale community-based programs. Linear programming tools can be used successfully to design local compositions that are in line with international guidelines, low in cost, and acceptable, and the efficacy of these local formulations in the treatment of MAM was recently demonstrated in Malawi. The production of local formulations for programs at scale relies on the existence of a reliable and efficient local production facility. Technical assistance may be required in the development of sustainable business models at an early stage in the process, taking into account the stringent product quality and safety criteria and the required investments. The use of ready-to-use products, as of any food supplement, in programs at scale will be affected by the practice of household sharing and diversion of these products for other uses. Additional measures can be considered to account for sharing. These products designed for the treatment and prevention of MAM are to be used in community-based programs and should therefore be used in conjunction with other interventions and designed so that they do not replace the intake of other foods and breastmilk. Remaining challenges and implications for the (operations) research agenda are discussed.

  15. Evaluation of the influence of dominance rules for the assembly line design problem under consideration of product design alternatives

    Science.gov (United States)

    Oesterle, Jonathan; Lionel, Amodeo

    2018-06-01

    The current competitive situation increases the importance of realistically estimating product costs during the early phases of product and assembly line planning projects. In this article, several multi-objective algorithms using difference dominance rules are proposed to solve the problem associated with the selection of the most effective combination of product and assembly lines. The list of developed algorithms includes variants of ant colony algorithms, evolutionary algorithms and imperialist competitive algorithms. The performance of each algorithm and dominance rule is analysed by five multi-objective quality indicators and fifty problem instances. The algorithms and dominance rules are ranked using a non-parametric statistical test.

  16. CLINICAL AND EPIDEMIOLOGIC CONSIDERATIONS OF CLOSTRIDIUM DIFFICILE IN HARBOR SEALS (PHOCA VITULINA) AT A MARINE MAMMAL REHABILITATION CENTER.

    Science.gov (United States)

    Anderson, Chelsea E; Haulena, Martin; Zabek, Erin; Habing, Gregory; Raverty, Stephen

    2015-06-01

    Between 1998 and 2008, 15 cases of segmental to diffuse hemorrhagic to necrohemorrhagic enterocolitis were diagnosed in neonatal and weaned juvenile harbor seals (Phoca vitulina) presented from the Vancouver Aquarium Marine Mammal Rescue Centre for rehabilitation. Based on a combination of gross pathology, histopathology, bacterial isolation, and toxin testing, Clostridium difficile enterocolitis was diagnosed. Most pups were anorexic or inappetant and died acutely with few other premonitory signs. Due to ongoing clinical concerns and possible emergence of this pathogen at the facility, efforts to better characterize the disease and understand the epidemiology of C. difficile was initiated in 95 harbor seal pups presented for rehabilitation in a single stranding season. Fecal samples were collected on admission, following completion of antibiotic treatment, and also prerelease or postmortem. All samples were collected fresh and submitted either directly or stored frozen. Fecal samples were inoculated into selective media for culture and screened by enzyme-linked immunosorbant assay (ELISA) for C. difficile toxins A, B, or both. Results of the 95 seals in the study were as follows: on hospital admit 72 seals were sampled, 10 were culture positive, 12 were ELISA positive; following antibiotic therapy 46 seals were sampled noting three culture positive and nine ELISA positive; prior to release 58 seals were sampled noting zero culture positive and one ELISA positive; and on postmortem exam seven seals were sampled noting zero culture positive and two ELISA positive. Clostridium difficile was not deemed to be the cause of death in any of the animals. Although the exact mechanism of disease is unknown, this study suggests that C. difficile infection is not a significant cause of mortality and may be part of the normal flora in harbor seals undergoing rehabilitation. Morbidity and mortality from this bacterium can likely be minimized by judicious use of antibiotics

  17. 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.

  18. A STUDY ON EFFECTIVENESS OF MULTIPLE AND SINGLE CELEBRITY ENDORSEMENT ON CONSIDERABLE PRODUCT ADVERTISEMENTS IN CHENNAI PERCEPTIVE, INDIA

    OpenAIRE

    A. Pughazhendi; Dr. K. Antony Baskaran; M. R. Prakash; R. N. Balamurugan

    2012-01-01

    The instrument of celebrity endorsement has nowadays become a pervasive element in advertising and communication management. The advertisers see this as an opportunity to grab and work on so as to expand their operations and promote their product. The purpose of this study is to explore the perceptual difference of consumer towards single celebrity endorsement and multiple celebrity endorsement more than one celebrity in a single advertisement for high and low involvement products and service...

  19. Metabolic Design of Corynebacterium glutamicum for Production of l-Cysteine with Consideration of Sulfur-Supplemented Animal Feed.

    Science.gov (United States)

    Joo, Young-Chul; Hyeon, Jeong Eun; Han, Sung Ok

    2017-06-14

    l-Cysteine is a valuable sulfur-containing amino acid widely used as a nutrition supplement in industrial food production, agriculture, and animal feed. However, this amino acid is mostly produced by acid hydrolysis and extraction from human or animal hairs. In this study, we constructed recombinant Corynebacterium glutamicum strains that overexpress combinatorial genes for l-cysteine production. The aims of this work were to investigate the effect of the combined overexpression of serine acetyltransferase (CysE), O-acetylserine sulfhydrylase (CysK), and the transcriptional regulator CysR on l-cysteine production. The CysR-overexpressing strain accumulated approximately 2.7-fold more intracellular sulfide than the control strain (empty pMT-tac vector). Moreover, in the resulting CysEKR recombinant strain, combinatorial overexpression of genes involved in l-cysteine production successfully enhanced its production by approximately 3.0-fold relative to that in the control strain. This study demonstrates a biotechnological model for the production of animal feed supplements such as l-cysteine using metabolically engineered C. glutamicum.

  20. Joint optimization of preventive maintenance and spare parts inventory for an optimal production plan with consideration of CO_2 emission

    International Nuclear Information System (INIS)

    Ba, Kader; Dellagi, Sofiene; Rezg, Nidhal; Erray, Walid

    2016-01-01

    This article presents a joint optimization of spare parts inventory and preventive maintenance. While minimizing CO_2 emissions, this approach is based on an optimal production plan achieved thanks to the HMMS model. The process which is studied in this paper only manufactures one type of product. The purpose of the paper is to determine for a random demand over a given period, a cost-effective production plan and a maintenance policy which integrates a spare parts strategy in accordance with environmental requirements and regulations. Our green spare parts management can be defined as a set of actions that are applied in order to decrease the spare parts footprint in its lifetime (Ba et al., 2015) [1]. Indeed, we take into account the spare parts characteristics (new or used) which will be used during maintenance actions (preventive or corrective) to preserve the environment. Consequently, we set up analytical models based on the effect of the production rate on the system deterioration so as to substantially cut the maintenance costs, production costs and CO_2 emissions. To evaluate the performance of our models, we give some illustrative examples. - Highlights: • Establishment of an optimal production plan for a manufacturing process. • Cost-effective maintenance strategy with a green spare parts strategy. • Possibility to choose between used and new spare parts to execute maintenance action.

  1. Regulatory and clinical aspects of psychotropic medicinal products bioequivalence.

    Science.gov (United States)

    Bałkowiec-Iskra, Ewa; Cessak, Grzegorz; Kuzawińska, Olga; Sejbuk-Rozbicka, Katarzyna; Rokita, Konrad; Mirowska-Guzel, Dagmara

    2015-07-01

    Introduction of generic medicinal products to the market has increased access to modern therapies but also enabled significant reduction in their cost, leading to containment of public expenditures on medicinal products reimbursement. The critical assessment of bioequivalence of any reference medicinal product and its counterpart is based on comparison of their rate and extent of absorption. It is assumed that two medicinal products are bioequivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. Bioequivalent medicinal products are declared to be also therapeutically equivalent and can be used interchangeably. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of this article is to provide a description of rules that guide registration of generic medicinal products in the European Union and to analyze specific examples from the scientific literature concerning therapeutic equivalence of reference and generic antidepressant and antipsychotic medicinal products. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

  2. Production and clinical evaluation of 99mTc-octreotide

    International Nuclear Information System (INIS)

    Fettich, J.; Kolenc-Peitl, P.

    2004-01-01

    Full text: Due to advantages of 99m-Tc labelled radiopharmaceuticals we examined the feasibility of producing 99m-Tcoctreotide in our laboratory and compare the results with 111-In-octreotide in the same patients. Keeping constant amount of components without exceeding amount of the peptide used, preparation of 99m-Tc-ethylendiaminediacetic- acidhydrazinonicotinamide-D-Phe1,Tyr3-octreotide (99m-Tc EDDA/HYNIC-TOC) was achieved. Radiochemical purity was tested using high-pressure liquid chromatography for 24 hours. In vitro stability testing of the product showed that radiochemical purity remained above 95% for 24 hours and the radiopharmaceutical was found suitable for human use. 5 - 10 μg of the peptide labelled with 550-650 MBq of 99m-Tc was prepared for each patient. 32 patients with clinically suspicious or confirmed carcinoid were investigated with 550 - 650 MBq 99m-Tcoctreotide prepared in our laboratory followed by 110 MBq 111-In-octreotide (Octreoscan, Mallinkrodt). Whole body scintigraphy and abdominal SPECT were performed 4 and 20 hrs after injection of respective radiopharmaceutical. In all patients both studies were acquired within 5 days. All patients gave informed consent for the study as required by Ethics committee. No abnormal tracer uptake was seen anywhere in the body in 12 patient with either of the radiopharmaceuticals. These were used to assess normal distribution of both radiopharmaceuticals. Normal accumulation was seen in case of both radiopharmaceuticals in the spleen, kidneys, liver and gallbladder. Biliary activity was seen in the gut in patients that were not well prepared for the study. There was significantly less activity seen in the kidneys in case of 99m-Tc-octreotide. This could be explained by higher hydrophilicity of the 99m-Tc-EDDA/HYNEC-TOC molecules as compared with 111-In-DTPA-octreotide. 20 patients with confirmed carcinoids showed abnormal uptake but without any difference in distribution of the two radiopharmaceuticals

  3. Pharmaceutical product cross-contamination: industrial and clinical ...

    African Journals Online (AJOL)

    problems. Pharmaceutical product cross-contamination is a serious problem which has been detected as an obstacle ... In the pharmaceutical care of patients in developed countries, cross-contamination ..... neonatal intensive care units.

  4. Evaluation of a marketing program designed to increase consumer consideration of energy-efficient products in Denver, Colorado

    Energy Technology Data Exchange (ETDEWEB)

    1978-08-01

    A demonstration marketing program to sensitize Denver homeowners to incorporate the energy cost of ownership orientation in their decision process regarding purchase of energy-efficient products is described. Personal interviews with Denver homeowners were conducted. A first survey established a baseline for consumer awareness and acceptance of energy conservation and conservation-related products and provided information which could be utilized in developing marketing strategies related to energy conservation and the concept of energy cost of ownership. A second survey measured shifts in awareness and attitudes which might have occurred as a result of the marketing demonstration program. The methodology and results of the evaluation are discussed in detail. The Denver Test Market Media Campaign conducted through multi-media advertising and public relations campaigns to sensitize the residents to the positive consideraton of energy-efficient products is described. (MCW)

  5. Subvisible (2-100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy.

    Science.gov (United States)

    Narhi, Linda O; Corvari, Vincent; Ripple, Dean C; Afonina, Nataliya; Cecchini, Irene; Defelippis, Michael R; Garidel, Patrick; Herre, Andrea; Koulov, Atanas V; Lubiniecki, Tony; Mahler, Hanns-Christian; Mangiagalli, Paolo; Nesta, Douglas; Perez-Ramirez, Bernardo; Polozova, Alla; Rossi, Mara; Schmidt, Roland; Simler, Robert; Singh, Satish; Spitznagel, Thomas M; Weiskopf, Andrew; Wuchner, Klaus

    2015-06-01

    Measurement and characterization of subvisible particles (defined here as those ranging in size from 2 to 100 μm), including proteinaceous and nonproteinaceous particles, is an important part of every stage of protein therapeutic development. The tools used and the ways in which the information generated is applied depends on the particular product development stage, the amount of material, and the time available for the analysis. In order to compare results across laboratories and products, it is important to harmonize nomenclature, experimental protocols, data analysis, and interpretation. In this manuscript on perspectives on subvisible particles in protein therapeutic drug products, we focus on the tools available for detection, characterization, and quantification of these species and the strategy around their application. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  6. Knowledge Creation in Clinical Product Development Management Research

    DEFF Research Database (Denmark)

    Karlsson, Christer; Sköld, Martin

    2012-01-01

    This paper explores the clinical approach to management research and positions it in relation to other similar approaches. It achieves this by pointing out the most important historical milestones in the development of such approaches. The literature on the approach is mapped, including that on t......This paper explores the clinical approach to management research and positions it in relation to other similar approaches. It achieves this by pointing out the most important historical milestones in the development of such approaches. The literature on the approach is mapped, including...... of the approaches, the paper discusses the research issues to which clinical research is relevant and how the research framework should be designed, then practical issues relating to how to approach the study objects, the design of the research instruments, and the conducting of the field research. Finally...

  7. 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).

  8. Ready-to-use foods for management of moderate acute malnutrition: Considerations for scaling up production and use in programs

    Science.gov (United States)

    Ready-to-use foods are one of the available strategies for the treatment of moderate acute malnutrition (MAM), but challenges remain in the use of these products in programs at scale. This paper focuses on two challenges: the need for cheaper formulations using locally available ingredients that are...

  9. ENERGY STAR® Retail Products Platform (RPP): Conditions and Considerations in Evaluating Market Transformation Programs and Evaluation Guidance for RPP

    Energy Technology Data Exchange (ETDEWEB)

    Li, Michael [U.S. Department of Energy; Banwell, Peter [U.S. Environmental Protection Agency

    2018-01-09

    The purpose of this guide is to provide a resource for state utility regulators, utilities, the evaluation community and regulatory stakeholders on methods to measure energy savings from the ENERGY STAR Retail Products Platform (link is external). The guidelines outlined in this document were developed by evaluation experts.

  10. Methanol production from Eucalyptus wood chips. Working document I. The Florida Eucalyptus energy farm: silvicultural methods and considerations

    Energy Technology Data Exchange (ETDEWEB)

    Fishkind, H.H.

    1982-04-01

    The silvicultural matrix within which the nation's first large scale wood energy plantation will develop is described in detail. The relevant literature reviewed is identified and distilled. The plantation history, site preparation, planting, species selection, maintenance and management, harvesting, and the Eucalyptus biomass production estimates are presented.

  11. 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

    2015-01-01

    Purpose: 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…

  12. 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.

  13. [A survey carried out among Italian physicians regarding non-required clinical examinations, treatments and procedures in the current clinical practice: results and considerations.

    Science.gov (United States)

    Vernero, Sandra; Giustetto, Guido

    2017-01-01

    A survey addressed to all Italian physicians regarding how they behave when a patient asks them to prescribe non-required clinical examinations, treatments and procedures has been carried out for the first time. The survey - realized during the last months of the year 2015 thanks to the collaboration between Slow Medicine and the National Federation of Associations of Doctors, Surgeons and Dentists - is based on a questionnaire given to the America physicians by the ABIM Foundation in 2014. The Italian survey results cannot be compared with the American ones because different approaches were used. 4,263 physicians started to fill in the questionnaire and 3,688 completed it. The results suggest that the physicians that answered the questions are highly aware of the over-usage of diagnostic tests and treatments, and among the main reasons they cite the need of safety and then the fear of legal consequences. Most of the physicians who answered the questions believe to be responsible for giving patients accurate information in order to avoid non-required practices, and that the physician is the right person with the most suitable role to face the problem. Among the most important and useful tools to reduce the prescription of non-required examinations and treatments, physicians indicate the possibility to have much more time available to discuss the different options with their patients, to arrange the evidence-based information material for the patients, and to explain the reform on the physician's responsibility (recently approved as law). Therefore, it stands out the opportunity to apply provisions aimed at providing the patients with more accurate information and at improving the relationship between the physician and the patient by ensuring on the one hand more availability of dedicated time and on the other hand the training of the physicians on scientific topics as well as on topics concerning communication and shared decisions. The communication can be

  14. Simultaneous consideration of TQM and TPM influence on production performance: A case study on multicolor offset machine using SD Model

    Directory of Open Access Journals (Sweden)

    Nagaraj H. Kamath

    2016-09-01

    Full Text Available An attempt is made in this research to show the relevance of System Dynamics (SD as a tool for simultaneously considering TQM and TPM environment in a offset machine of a commercial printing press. By controlling the TQM and TPM variables, this model will attempt to simulate or predict the behavior of an efficient printing operation. Identifying other scenarios pertaining to Human factors, affecting the socio-technical variables is the future research work of this paper. The practical implication concerns the efficient decision making system in multi-colour sheet feed offset printing, by controlling the socio-technical variables. This is a novel approach of combining different socio-technical variables SD and Cased based approach for obtaining a productive environment in print operation called “Total Production Management”.

  15. Safety considerations and countermeasures against fire and explosion at an HTGR-hydrogen production system. Proposal of safety design concept

    International Nuclear Information System (INIS)

    Nishihara, T.; Hada, K.; Shibata, T.; Shiozawa, S.

    1996-01-01

    Establishment of safety design concept and countermeasures against fire and explosion accidents is among key safety-related issues in an HTGR-hydrogen production system. We propose the different safety design concepts depending upon the origin of fire and explosion which may happen in the HTGR-hydrogen production plant. Against fire and explosion originated outside the reactor building (R/B), namely in the area of hydrogen production plant, the safety design concept is primarily to take a safe distance for preventing the damage on safety-related items or a proof wall if necessary. Because the hydrogen production plant is designed in the same safety level as a conventional chemical plant. The safe distance is proposed to limit an incident overpressure to 10 kPa so as not to suffer any damage on the items and to limit a wall-averaged temperature of concrete structures of the R/B to 175degC according to the current regulation. On the other hand, against a potential possibility of explosion originated inside the R/B, the safety design concept is to minimize the possibility of explosion low enough to assume no occurrence inside the R/B. That is, the measure is to exclude a simultaneous failure of a secondary helium piping and an endothermic chemical reactor. Furthermore, in severe accident condition in which the explosion may be postulated a priori, an incidental overpressure of explosion inside the reactor containment vessel (C/V) should be limited so as not to fail the C/V through restricting the amount of combustible gas ingress into the C/V by means of a combination of C/V isolation valve installed in the helium piping and emergency shut off valve in the process feed gas line. (author)

  16. Production and availability of 99mTc generators and of 99Mo: technology considerations and the IAEA's contributions

    International Nuclear Information System (INIS)

    Ramamoorthy, N.; )

    2007-01-01

    The serendipitous discovery of 99m T c generator at the BNL, USA in 1957 laid the foundation for the subsequent revolution of in vivo imaging of physiological functions in humans to aid diagnostic decisions and patient management. The widespread use of diagnostic imaging in nuclear medicine would not have attained a pre-eminent status world over but for the 99m T c generator and 99m T c labelled products. In order to sustain the nearly 20 million studies annually performed using 99m T c , it is of utmost importance to assure access to appropriate technologies for continued, reliable availability of 99m T c generators and in turn, that of the raw material radionuclide 99 Mo required in extremely large quantities. A walk down the path of their production technologies to trace the trends and issues reveals several major milestones. The IAEA has been involved for well over three decades in fostering developments in 99m T c generator systems through (i) implementation of a number of CRPs including an on-going one related to the production of 99 Mo using LEU targets, (ii) arranging expert reviews through Technical/Consultancy Meetings and (iii) publication of various technical documents, e.g. IAEA-TECDOC: 515 (1989), 852, (1995), 1051 (1998) and 1065 (1999). The IAEA has also supported a number of interested Member States in establishing and/or operating 99m T c generator production facilities, as for example in Bangladesh, China, Indonesia, Iran, Pakistan and Syria. The author has been involved in several of the above initiatives of the IAEA and was also an active participant in the Indian programmes on 99m T c generators during 1972 to 2003. The present review is accordingly tailored as a narration, interspersed with the IAEA's important contributions and glimpses of the Indian scenario. (author)

  17. Atmospheric Inversion of the Global Surface Carbon Flux with Consideration of the Spatial Distributions of US Crop Production and Consumption

    Science.gov (United States)

    Fung, Jonathan Winston

    Carbon dioxide is taken up by crops during production and released back to the atmosphere at different geographical locations through respiration of consumed crop commodities. In this study, spatially distributed county-level US cropland net primary productivity, harvested biomass, changes in soil carbon, and human and livestock consumption data were integrated into the prior terrestrial biosphere flux generated by the Boreal Ecosystem Productivity Simulator (BEPS). A global time-dependent Bayesian synthesis inversion with a nested focus on North America was carried out based on CO2 observations at 210 stations. Overall, the inverted annual North American CO2 sink weakened by 6.5% over the period from 2002 to 2007 compared to simulations disregarding US crop statistical data. The US Midwest is found to be the major sink of 0.36±0.13 PgC yr-1 whereas the large sink in the US Southeast forests weakened to 0.16±0.12 PgC yr-1 partly due to local CO2 sources from crop consumption.

  18. Fertilizer nitrogen recovery efficiencies in crop production systems of China with and without consideration of the residual effect of nitrogen

    International Nuclear Information System (INIS)

    Yan, Xiaoyuan; Ti, Chaopu; Zhu, Zhaoliang; Vitousek, Peter; Chen, Deli; Leip, Adrian; Cai, Zucong

    2014-01-01

    China is the world’s largest consumer of synthetic nitrogen (N), where very low rates of fertilizer N recovery in crops have been reported, raising discussion around whether fertilizer N use can be significantly reduced without yield penalties. However, using recovery rates as indicator ignores a possible residual effect of fertilizer N—a factor often unknown at large scales. Such residual effect might store N in the soil increasing N availability for subsequent crops. The objectives of the present study were therefore to quantify the residual effect of fertilizer N in China and to obtain more realistic rates of the accumulative fertilizer N recovery efficiency (RE) in crop production systems of China. Long-term spatially-extensive data on crop production, fertilizer N and other N inputs to croplands in China were used to analyze the relationship between crop N uptake and fertilizer N input (or total N input), and to estimate the amount of residual fertilizer N. Measurement results of cropland soil N content in two time periods were obtained to compare the change in the soil N pool. At the provincial scale, it was found that there is a linear relationship between crop N uptake and fertilizer N input or total N input. With the increase in fertilizer N input, annual direct fertilizer N RE decreased and was indeed low (below 30% in recent years), while its residual effect increased continuously, to the point that 40–68% of applied fertilizer was used for crop production sooner or later. The residual effect was evidenced by a buildup of soil N and a large difference between nitrogen use efficiencies of long-term and short-term experiments. (paper)

  19. Considerations on patient-related outcomes with the use of botulinum toxins: is switching products safe?

    Directory of Open Access Journals (Sweden)

    Fraint A

    2016-02-01

    Full Text Available Avram Fraint,1 Padmaja Vittal,2 Cynthia Comella2 1Department of Neurological Sciences, 2Section of Movement Disorders, Rush University Medical Center, Chicago, IL, USA Introduction: Botulinum toxin (BoNT is the treatment of choice for many neurologic movement disorders, including blepharospasm, hemifacial spasm, and cervical dystonia. There are two serotypes approved for use by the US Food and Drug Administration: three brands of serotype A and one of serotype B. Many attempts have been made at establishing dose conversion ratios between brands and serotypes. This review focuses on the existing data comparing different formulations of the same BoNT serotypes as well as that comparing different serotypes with one another. We focus on existing data regarding switching from one formulation or serotype to another and will also discuss the issue of immunogenicity of BoNT. With this information as a foundation, recommendations on safety of switching agents are addressed. Method: Literature review searching PubMed and Google Scholar using the search terms “switching botox”, “dosing equivalency in botox”, and “comparing botox”. Results/conclusion: Overall, there are many studies that demonstrate the efficacy and safety of each of the brands of BoNTs used in clinical practice. However, determination of dosing equivalencies among these brands and serotypes is complex with inconsistencies among the studies. When switching from one brand to another, the clinician should be aware of these issues, and not make the assumption that such ratios exist. Tailoring the dosage of each brand of BoNT to the clinical situation is the most prudent treatment strategy rather than focusing closely on conversion factors and concerns for immunogenicity. Keywords: botulinum toxin, BoNT, abobotulinumtoxin A, onabotulinumtoxin A, incobotulinumtoxin A, rimabotulinumtoxin B

  20. Production of large-area polymer solar cells by industrial silk screen printing, lifetime considerations and lamination with polyethyleneterephthalate

    DEFF Research Database (Denmark)

    Krebs, Frederik C; Alstrup, J.; Spanggaard, H.

    2004-01-01

    The possibility of making large area (100 cm(2)) polymer solar cells based on the conjugated polymer poly 1,4-(2-methoxy-5-ethylhexyloxy)phenylenevinylene (MEH-PPV) was demonstrated. Devices were prepared by etching an electrode pattern on ITO covered polyethyleneterephthalate (PET) substrates....... A pattern of conducting silver epoxy allowing for electrical contacts to the device was silk screen printed and hardened. Subsequently a pattern of MEH-PPV was silk screen printed in registry with the ITO electrode pattern on top of the substrate. Final evaporation of an aluminum electrode or sublimation......). The half-life based on I-sc in air for the devices were 63 h. The cells were laminated in a 125 mum PET encasement. Lamination had a negative effect on the lifetime. We demonstrate the feasibility of industrial production of large area solar cells (1 m(2)) by silk screen printing and envisage...

  1. Memory of antiquity and new compatible museum functions Some considerations on the industrial heritage related to electricity production

    Directory of Open Access Journals (Sweden)

    Emanuele Romeo

    2017-12-01

    Full Text Available The industrial heritage is represented by a set of strongly stratified architectural complexes characterized by different technical, formal, and distributive solutions that were gradually added and superimposed to one another, when required by the evolution of technology and by the changes in production processes. Actually, it is this stratification (additions, changes of use, momentary abandonment and subsequent reuse, accompanied by architectural and technological adjustments that gives an industrial complex a particular value.Indeed, the continuous evolution is the essence of this particular architectural form. From the birth of the first factories to present day, the industrial buildings have been able to quickly change their architectural form and their material and formal consistency according for the work and production needs. For this reason, we have now the opportunity to read a "history of architecture" consisting of a sequence of materials and technologies that have been subsequently replaced or superimposed to one another, in a list of examples related to the testing of reinforced concrete, of iron, cast iron, steel; or to the use of large glass surfaces or shed roofs; or to the use of natural and artificial energy sources. Many European experiences of conservation and reuse of industrial buildings have already considered this approach: the choice of the new functions is dictated by the flexibility of the building towards the necessary technical and energy adjustments. This is to achieve a proper balance between respect for the historical memory of the building and the need to adapt to the standards of energy, social and cultural sustainability.

  2. Preliminary consideration of a double, 480 GeV, fast cycling proton accelerator for production of neutrino beams at Fermilab

    Energy Technology Data Exchange (ETDEWEB)

    Piekarz, Henryk; Hays, Steven; /Fermilab

    2007-03-01

    We propose to build the DSF-MR (Double Super-Ferric Main Ring), 480 GeV, fast-cycling (2 second repetition rate) two-beam proton accelerator in the Main Ring tunnel of Fermilab. This accelerator design is based on the super-ferric magnet technology developed for the VLHC, and extended recently to the proposed LER injector for the LHC and fast cycling SF-SPS at CERN. The DSF-MR accelerator system will constitute the final stage of the proton source enabling production of two neutrino beams separated by 2 second time period. These beams will be sent alternately to two detectors located at {approx} 3000 km and {approx} 7500 km away from Fermilab. It is expected that combination of the results from these experiments will offer more than 3 order of magnitudes increased sensitivity for detection and measurement of neutrino oscillations with respect to expectations in any current experiment, and thus may truly enable opening the window into the physics beyond the Standard Model. We examine potential sites for the long baseline neutrino detectors accepting beams from Fermilab. The current injection system consisting of 400 MeV Linac, 8 GeV Booster and the Main Injector can be used to accelerate protons to 45 GeV before transferring them to the DSF-MR. The implementation of the DSF-MR will allow for an 8-fold increase in beam power on the neutrino production target. In this note we outline the proposed new arrangement of the Fermilab accelerator complex. We also briefly describe the DSF-MR magnet design and its power supply, and discuss necessary upgrade of the Tevatron RF system for the use with the DSF-MR accelerator. Finally, we outline the required R&D, cost estimate and possible timeline for the implementation of the DSF-MR accelerator.

  3. Production of a Novel OX40 Ligand for Clinical Use

    Science.gov (United States)

    2012-10-01

    that mutating the OX40L:Ig sequence would lead to a “safer” profile for FDA screening purposes, it was not clear whether mutating this sequence... green monkey kidney cell line, Vero, fits this description and was used. The indicator cells are maintained by WuXi AppTec’s Cell Production Laboratory...extra-nuclear and typically appears as small round bodies approximately 0.3 fim in diameter. 10.2 Direct Assay Change in color or turbidity of broth

  4. 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

  5. A trust-wide review of clinical nurse specialists' productivity.

    Science.gov (United States)

    Balsdon, Helen; Wilkinson, Susan

    2014-04-01

    The contribution made by clinical nurse specialists (CNSs) to patient care needs to be understood fully to provide assurance of effective use of resources. However, CNS roles are often poorly understood and not easily articulated. Due to the diversity of these roles, robust reviews of performance and economic benefits can be regarded as time consuming and resource intense, and many organisations enlist external agencies to clarify the contribution to care made by their CNSs. This article gives an overview of a Cambridge University Hospitals NHS Foundation Trust internal review of CNS roles without the support of an external agency. The review provided assurance that this group of nurses is being used effectively and identified opportunities to use the role in different ways to increase effectiveness.

  6. MODE OF PRODUCTION AND EDUCATION: CONSIDERATIONS ABOUT EDUCATION IN THE CAPITALIST REPRODUCTION AND IN THE TRANSITION TO THE SOCIALISM

    Directory of Open Access Journals (Sweden)

    Patrícia Vieira Trópia

    2009-06-01

    Full Text Available This text works about the relation between mode of production and education, from the contributions of the althusseriana view. The contributions of this approach allow the overcoming review to the economicist and reductionist view about the kind of articulation between the base/economic structure and the political and ideological superstructure and its implications for education. From this point of view, the school, the school education, is really a place of contradiction. However, any internal transformation to the school to make it, in fact, a school to serve the working classes would demand a breakup with the organic commitment of the educational unit. But from different approaches, economism and structuralism, come the question: “although some criticisms to the traps of the non-economist reviews are pertinent, cannot the rejection of the tests developed by the ‘sociological criticism of the education’ in the educational field put us in so many others and more devilish traps, such as those from idealism and reformism?”.

  7. Herbal products in pregnancy: experimental studies and clinical reports.

    Science.gov (United States)

    Smeriglio, Antonella; Tomaino, Antonio; Trombetta, Domenico

    2014-08-01

    The aim of this work is to provide an update from an overview of the literature of the most frequently consumed herbal remedies during pregnancy, both alone and concomitantly with prescribed medications and particularly on their side effects to the mother and fetus. We have also analyzed some of the adverse interactions that may occur due to concomitant use of herbal and pharmaceutical products during pregnancy. Herbal remedies are not evaluated according to the same standards as pharmaceuticals, and in the USA some of it are not licensed but sold as food supplements. There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines used in pregnancy and lactation. If 'traditional use' is the only available information, the pregnant woman should be made aware of this to enable her to make an informed decision concerning potential use. Copyright © 2014 John Wiley & Sons, Ltd.

  8. Cyclotron production of {sup 44}Sc for clinical application

    Energy Technology Data Exchange (ETDEWEB)

    Krajewski, S.; Bilewicz, A. [Institute of Nuclear Chemistry and Technology, Warsaw (Poland); Cydzik, I. [Institute of Nuclear Chemistry and Technology, Warsaw (Poland); European Commission Joint Research Center, Ispra (Italy). Inst. for Health and Consumer Protection; Warsaw Univ. (Poland). Heavy Ion Lab.; Abbas, K. [European Commission Joint Research Center, Ispra (Italy). Institute for Transuranium Elements; Bulgheroni, A.; Simonelli, F.; Holzwarth, U. [European Commission Joint Research Center, Ispra (Italy). Inst. for Health and Consumer Protection

    2013-08-01

    {sup 44} is a promising {beta}{sup +}-emitter for molecular imaging with intermediate half-life of 4 h. Due to the chemical similarity of Sc{sup 3+} to the Lu{sup 3+} and Y{sup 3+} cations, {sup 44}Sc-DOTA bioconjugates are expected to demonstrate similar properties in vivo as the {sup 177}Lu- and {sup 90}Y-bioconjugates, what is important in planning the radionuclide therapy. {sup 44}Sc can be obtained from the {sup 44}Ti/{sup 44}Sc generator. An alternative method for {sup 44}Sc production can be the irradiation of {sup 44}Ca target at small cyclotrons. The aim of our work was to optimize the parameters of {sup 44}CaCO{sub 3} irradiation and to develop a simple procedure for {sup 44}Sc separation from the calcium target. For optimization study, {sup 44}CaCO{sub 3} targets were irradiated by protons in the energy range of 5.6-17.5 MeV with 9 MeV being found to be the best energy for {sup 44}Ca irradiations. A simple and fast separation procedure of {sup 44}Sc from calcium target was developed using chelating resin Chelex 100. DOTATATE conjugate was successfully radiolabelled with high yield at elevated temperature using the produced {sup 44}Sc. While {sup 44}CaCO{sub 3} is relatively expensive, the cost of {sup 44}Sc-DOTATATE production can be reduced by target recovery. Due to low proton energy required to produce GBq activity level of {sup 44}Sc, the availability of {sup 44}Sc radioisotope could be enhanced to open new opportunities for applications in medical imaging. (orig.)

  9. Thoracic lateral extracavitary corpectomy for anterior column reconstruction with expandable and static titanium cages: clinical outcomes and surgical considerations in a consecutive case series.

    Science.gov (United States)

    Holland, Christopher M; Bass, David I; Gary, Matthew F; Howard, Brian M; Refai, Daniel

    2015-02-01

    Many surgical interventions have emerged as effective means of restoring mechanical stability of the anterior column of the spine. The lateral extracavitary approach (LECA) allows for broad visualization and circumferential reconstruction of the spinal column. However, early reports demonstrated significant complication rates, protracted operative times, and prolonged hospitalizations. More recent reports have highlighted concerns for subsidence, particularly with expandable cages. Our work seeks to describe a single-surgeon consecutive series of patients undergoing LECA for thoracic corpectomy. Specifically, the objective was to explore the surgical considerations, clinical and radiographic outcomes, and complication profile of this approach. A retrospective study examined data from 17 consecutive patients in whom single or multi-level corpectomy was performed via a LECA by a single surgeon. Vertebral body replacement was achieved with either a static or expandable titanium cage. The Karnofsky Performance Scale (KPS) was utilized to assess patient functional status before and after surgery. Radiographic outcomes, particularly footplate-to-body ratio and subsidence, were assessed on CT imaging at 6 weeks after surgery and at follow-up of at least 6 months. The majority of patients had post-operative KPS scores consistent with functional independence (≥70, 12/17 patients, 71%). Fourteen patients had improved or maintained function by last follow-up. In both groups, all patients had a favorable footplate-to-body ratio, and rates of subsidence were similar at both time points. Notably, the overall complication rate (24%) was significantly lower than that published in the literature, and no patient suffered a pneumothorax that required placement of a thoracostomy tube. The LECA approach for anterior column reconstruction with static or expandable cages is an important surgical consideration with favorable surgical parameters and complication rates. Further, use of

  10. 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.

  11. An audit of health products and services marketed on chiropractic websites in Alberta and consideration of these practices in the context of chiropractic codes of conduct and ethics.

    Science.gov (United States)

    Page, Stacey A

    2007-06-01

    Chiropractic's success as a health care profession is evidenced in part by the rising number of practitioners. Paradoxically, this success may start to cost the profession, as the number of consumers may not be increasing proportionally. Fewer patients mean less income for practitioners. Some chiropractors are responding to these pressures by marketing health products, and services. To describe the extent to which Alberta chiropractors with websites sold health products and the extent to which fee discounts/service inducements were advertised. To consider these practices in the context of chiropractic codes of conduct and ethics. Chiropractic websites in the province of Alberta were identified using the online Telus Business Finder and cross-referenced with the Yellow Pages print directories. The websites were searched and an inventory of the health products for sale was recorded. Fee discounts and service inducements were also recorded. 56 websites were identified and reviewed. Just under two-thirds of the chiropractic websites surveyed contained information on health products for sale. Orthotics were sold most often (N = 29 practices; 51.8%), followed by pillows and supports (N = 15: 26.8%), vitamins/nutritional supplements (N = 15; 26.8%) and exercise/rehabilitation products (N = 10; 17.9%). Nine practices (16.1%) offered some type of inducement to potential customers. These included discounts on treatment packages (N = 2; 3.6%), free gait/ posture analyses (N = 2; 3.6%) and free general consultations with the chiropractors (N = 3; 5.4%) The marketing of health care products and services by chiropractors in Alberta is common. Such practices raise ethical considerations for the profession. Professional guidelines vary on the acceptability of these practices. Consumer and practitioner perspectives and practices regarding retailing need to be further examined.

  12. 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

  13. 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.

  14. On transcending the impasse of respiratory motion correction applications in routine clinical imaging - a consideration of a fully automated data driven motion control framework

    International Nuclear Information System (INIS)

    Kesner, Adam L; Schleyer, Paul J; Büther, Florian; Walter, Martin A; Schäfers, Klaus P; Koo, Phillip J

    2014-01-01

    Positron emission tomography (PET) is increasingly used for the detection, characterization, and follow-up of tumors located in the thorax. However, patient respiratory motion presents a unique limitation that hinders the application of high-resolution PET technology for this type of imaging. Efforts to transcend this limitation have been underway for more than a decade, yet PET remains for practical considerations a modality vulnerable to motion-induced image degradation. Respiratory motion control is not employed in routine clinical operations. In this article, we take an opportunity to highlight some of the recent advancements in data-driven motion control strategies and how they may form an underpinning for what we are presenting as a fully automated data-driven motion control framework. This framework represents an alternative direction for future endeavors in motion control and can conceptually connect individual focused studies with a strategy for addressing big picture challenges and goals. The online version of this article (doi:10.1186/2197-7364-1-8) contains supplementary material, which is available to authorized users.

  15. New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia® for contraception and for treatment of heavy menstrual bleeding: patient considerations

    Directory of Open Access Journals (Sweden)

    Nelson AL

    2012-12-01

    Full Text Available Anita L NelsonObstetrics and Gynecology, David Geffen School of Medicine at UCLA, Harbor UCLA Medical Center, Torrance, California, USAAbstract: Natazia® is a new oral contraceptive with estradiol valerate and dienogest in a unique multiphasic formulation that includes a shortened hormone-free interval. This new formulation has been approved for both contraception and also as a treatment for heavy menstrual bleeding in women who desire to use oral contraceptives as their method of birth control. It is marketed in the US as Natazia® and elsewhere as Qlaira®. This article will review the properties of each of the major new features of this pill: estradiol used in place of ethinyl estradiol, dienogest as the progestin, and the unique dosing pattern of this product. It will also summarize the results of the pivotal clinical trials of contraceptive effectiveness, bleeding patterns, safety and tolerability. The lessons learned from the clinical trials about the effectiveness of this formulation in the treatment of excessive menstrual bleeding will be summarized. Also, results of trials comparing this new pill to other popular formulations for "menstrually-related" symptoms and for potential female sexual dysfunction related to use of oral contraceptives will be presented. This review will suggest how all this information might be used to counsel women about how to use this pill most successfully.Keywords: oral contraceptives, estradiol valerate, dienogest, heavy menstrual bleeding, menorrhagia, dynamic dosing

  16. Fiscal considerations

    International Nuclear Information System (INIS)

    Wheeler, C.

    1992-01-01

    Most fiscal systems do not have provisions which adequately address the problems arising from the global nature of international oil and product trading. It is also difficult for the various tax authorities to keep abreast of the ever evolving hedging instruments. It is quite possible for an international trader or integrated oil company to find itself with losses which cannot match against profits either because of local tax rules or because the loss arises in one jurisdiction and profits in another. The corporate structuring and legal relationships of parties both within an organisation and outside can be key to mitigating effective double taxation and in assisting the production of reports to shareholders which show a fair picture of the group's activities. (author)

  17. 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.

  18. Study of activity based costing implementation for palm oil production using value-added and non-value-added activity consideration in PT XYZ palm oil mill

    Science.gov (United States)

    Sembiring, M. T.; Wahyuni, D.; Sinaga, T. S.; Silaban, A.

    2018-02-01

    Cost allocation at manufacturing industry particularly in Palm Oil Mill still widely practiced based on estimation. It leads to cost distortion. Besides, processing time determined by company is not in accordance with actual processing time in work station. Hence, the purpose of this study is to eliminates non-value-added activities therefore processing time could be shortened and production cost could be reduced. Activity Based Costing Method is used in this research to calculate production cost with Value Added and Non-Value-Added Activities consideration. The result of this study is processing time decreasing for 35.75% at Weighting Bridge Station, 29.77% at Sorting Station, 5.05% at Loading Ramp Station, and 0.79% at Sterilizer Station. Cost of Manufactured for Crude Palm Oil are IDR 5.236,81/kg calculated by Traditional Method, IDR 4.583,37/kg calculated by Activity Based Costing Method before implementation of Activity Improvement and IDR 4.581,71/kg after implementation of Activity Improvement Meanwhile Cost of Manufactured for Palm Kernel are IDR 2.159,50/kg calculated by Traditional Method, IDR 4.584,63/kg calculated by Activity Based Costing Method before implementation of Activity Improvement and IDR 4.582,97/kg after implementation of Activity Improvement.

  19. 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.

  20. A global survey of clinicians' awareness, accessibility, utilization of e-continuous education, and quality of clinical blood use: policy considerations

    Directory of Open Access Journals (Sweden)

    Smit Sibinga CT

    2017-07-01

    . Three research questions were answered, while seven null hypotheses were tested at 0.05 level of significance. Descriptive statistical tools (frequency counts and percentage were used to analyze demographic backgrounds; inferential statistics – Pearson product-moment correlation coefficient (PPMCC and analysis of variance (ANOVA were used to analyze hypotheses.Results: Quality of clinical blood use was positively and significantly correlated with the level of awareness (r=0.137; p=0.03; df=262 and accessibility (r=0.184; p=0.01; df=262 to e-continuous learning among clinicians/nurses. There was a significant difference in the levels of awareness (F[3,260]=53.942, p=0.01, accessibility (F[3,260]=38.582, p=0.01, and utilization (F[3,260]=24.858, p=0.01 of continuous e-learning and education among clinicians/nurses based on HDI grouping, particularly between very high and low HDI. Furthermore, there was a significant difference in the levels of accessibility (F[6,257]=6.444, p=0.01 and utilization (F[6,257]=13.704, p=0.01 of continuous e-learning and education among clinicians based on clinical specialty/department and a significant difference in the quality of clinical blood use based on clinical specialty/department (F[6,257]=9.677, p=0.01.Conclusion and recommendations: The higher the HDI level the better is the awareness, accessibility, and utilization of continuous education, both through e-learning and conventional in teaching curricula. This has an immediate impact on the quality of clinical care and in particular on supportive hemotherapy and the development of patient blood management systems. Keywords: continuous E-learning and education programs, awareness, accessibility, utilization, blood prescribing clinicians/nurses, Human Development Index, quality management, clinical blood use, patient blood management

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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...

  6. 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.

  7. 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)

  8. 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

  9. 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

  10. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  12. 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.

  13. 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.

  14. 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.

  15. CLINICAL AND PHYSIOLOGICAL EVALUATION OF SPECIALIZED FOOD PRODUCT FOR PREGNANT WOMEN

    Directory of Open Access Journals (Sweden)

    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..

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. Functional and clinical evaluation of renal injury in patients treated with adjuvant chemoradiotherapy for gastric cancer: Low dose and comorbidity considerations

    Directory of Open Access Journals (Sweden)

    Roman Ibrahimov

    2016-01-01

    Conclusion: Functional renal impairment without any clinical signs or symptoms can be observed in low doses after radiotherapy. Careful treatment planning and a detailed evaluation of the functional renal capacity before treatment may help to reduce late renal toxicity.

  4. 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.

  5. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI).

    Science.gov (United States)

    Moussa, Issam D; Klein, Lloyd W; Shah, Binita; Mehran, Roxana; Mack, Michael J; Brilakis, Emmanouil S; Reilly, John P; Zoghbi, Gilbert; Holper, Elizabeth; Stone, Gregg W

    2014-01-01

    Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker thresholds for defining percutaneous coronary intervention (PCI)-related MI (type 4a) and coronary artery bypass grafting (CABG)-related MI (type 5) which are of uncertain prognostic importance. In addition, for both MI types cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK-MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than employing an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large-scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a "clinically relevant MI." The present document introduces a new definition for "clinically relevant MI" after coronary revascularization (PCI or CABG) which is applicable for use in clinical trials, patient care, and quality outcomes assessment. Copyright © 2013 Wiley Periodicals, Inc.

  6. 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...

  7. 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

  8. 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

  9. The impact of physician burnout on clinical and academic productivity of gynecologic oncologists: A decision analysis.

    Science.gov (United States)

    Turner, Taylor B; Dilley, Sarah E; Smith, Haller J; Huh, Warner K; Modesitt, Susan C; Rose, Stephen L; Rice, Laurel W; Fowler, Jeffrey M; Straughn, J Michael

    2017-09-01

    Physician burnout is associated with mental illness, alcohol abuse, and job dissatisfaction. Our objective was to estimate the impact of burnout on productivity of gynecologic oncologists during the first half of their career. A decision model evaluated the impact of burnout on total relative value (RVU) production during the first 15years of practice for gynecologic oncologists entering the workforce from 2011 to 2015. The SGO practice survey provided physician demographics and mean annual RVUs. Published data were used to estimate probability of burnout for male and female gynecologic oncologists, and the impact of depression, alcohol abuse, and early retirement. Academic productivity was defined as annual PubMed publications since finishing fellowship. Without burnout, RVU production for the cohort of 250 gynecologic oncologists was 26.2 million (M) RVUs over 15years. With burnout, RVU production decreased by 1.6 M (5.9% decrease). Disproportionate rates of burnout among females resulted in 1.1 M lost RVUs for females vs. 488 K for males. Academic production without burnout was estimated at 9277 publications for the cohort. Burnout resulted in 1383 estimated fewer publications over 15years (14.9%). The impact of burnout on clinical and academic productivity is substantial across all specialties. As health care systems struggle with human resource shortages, this study highlights the need for effective burnout prevention and wellness programs for gynecologic oncologists. Unless significant resources are designated to wellness programs, burnout will increasingly affect the care of our patients and the advancement of our field. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

    Science.gov (United States)

    Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

    2014-01-01

    The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

  11. Medical Care in a Free Clinic: A Comprehensive Evaluation of Patient Experience, Incentives, and Barriers to Optimal Medical Care with Consideration of a Facility Fee.

    Science.gov (United States)

    Birs, Antoinette; Liu, Xinwei; Nash, Bee; Sullivan, Sara; Garris, Stephanie; Hardy, Marvin; Lee, Michael; Simms-Cendan, Judith; Pasarica, Magdalena

    2016-02-19

    Free and charitable clinics are important contributors to the health of the United States population. Recently, funding for these clinics has been declining, and it is, therefore, useful to identify what qualities patients value the most in clinics in an effort to allocate funding wisely. In order to identify targets and incentives for improvement of patients' health, we performed a comprehensive analysis of patients' experience at a free clinic by analyzing a patient survey (N=94). The survey also assessed patient opinions of a small facility fee, which could be used to offset the decrease in funds. Interestingly, our patients believed it is appropriate to be charged a facility fee (78%) because it increases involvement in their care (r = 0.69, p fee. Barriers include affordable housing, transportation, medication, and accessible information. In order to improve medical care in the uninsured population, our study suggested that we need to: 1) offer continuity of medical care; 2) offer affordable preventive health screenings; 3) support affordable transportation, housing, and medications; and 4) consider including a facility fee.

  12. Determination of Eligibility in Related Pediatric Hematopoietic Cell Donors: Ethical and Clinical Considerations. Recommendations from a Working Group of the Worldwide Network for Blood and Marrow Transplantation Association.

    Science.gov (United States)

    Bitan, Menachem; van Walraven, Suzanna M; Worel, Nina; Ball, Lynne M; Styczynski, Jan; Torrabadella, Marta; Witt, Volker; Shaw, Bronwen E; Seber, Adriana; Yabe, Hiromasa; Greinix, Hildegard T; Peters, Christina; Gluckman, Eliane; Rocha, Vanderson; Halter, Joerg; Pulsipher, Michael A

    2016-01-01

    Related donors for hematopoietic cell (HC) transplantation are a growing population in recent years because of expanding indications for allogeneic transplantation. The safety and welfare of the donor are major concerns for the transplantation community, especially for related sibling donors of young recipients who are children and, thus, not able to fully consent. Because donation of HC does not improve the donor's own physical health and carries a risk of side effects, careful assessment of medical risks specific to the individual donor, as well as consideration of ethical and legal aspects associated with donation from a child, must be considered. In addition, donor centers must balance the needs of both the donor and the recipient, understanding the inherent conflict parents may have as they can be overly focused on the very sick child receiving a transplant, rather than on the relatively less significant health or emotional problems that a sibling donor may have, which could impact risk with donation. Likewise, consideration must be made regarding the nature of the relationship of the sibling donor to the recipient and also aspects of performing research on pediatric HC donors. In this article, as members of the Donor Issues Committee of the Worldwide Network for Blood and Marrow Transplantation, we review key ethical concerns associated with pediatric donation and then give recommendations for screening potential child donors with underlying health conditions. These recommendations are aimed at protecting the physical and emotional well-being of childhood donors and arise out of the Third International Conference on Health and Safety of Donors sponsored by the Worldwide Network for Blood and Marrow Transplantation. Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  13. Molecular allergy diagnostics using IgE singleplex determinations: methodological and practical considerations for use in clinical routine: Part 18 of the Series Molecular Allergology.

    Science.gov (United States)

    Kleine-Tebbe, Jörg; Jakob, Thilo

    Allergen molecules (synonyms: single allergens, allergen components) open up new horizons for the targeted allergen-specific diagnostics of immunoglobulin E (IgE) in singleplex determination. The following rationales support the targeted use of allergen molecules and, more importantly, improve test properties: (1) increased test sensitivity ("analytical sensitivity"), particularly when important allergens are under-represented or lacking in the extract; (2) improved test selectivity (analytical specificity), particularly when the selected IgE repertoire against an allergen yields additional information on: (a) potential risk, (b) possible cross-reactivity, or (c) primary (species-specific) sensitization. However, the appropriate indication for the use of single allergens can only be established on a case-by-case basis (depending on the clinical context and previous history) and in an allergen-specific manner (depending on the allergen source and the single allergens available), rather than in a standardized way. Numerous investigations on suspected food allergy, insect venom allergy, or sensitization to respiratory allergens have meanwhile demonstrated the successful use of defined molecules for allergen-specific singleplex IgE diagnosis. Specific IgE to single allergens is limited in its suitability to predict the clinical relevance of sensitivity on an individual basis. In food allergies, one can at best identify the relative risk of a clinical reaction on the basis of an IgE profile, but no absolutely reliable prediction on (future) tolerance can be made. Ultimately, the clinical relevance of all IgE findings depends on the presence of corresponding symptoms and can only be assessed on an individual basis (previous history, symptom log, and provocation testing with the relevant allergen source where appropriate). Thus, also in molecular allergology, the treating physician and not the test result should determine the clinical relevance of diagnostic findings

  14. Use of the i2b2 research query tool to conduct a matched case-control clinical research study: advantages, disadvantages and methodological considerations.

    Science.gov (United States)

    Johnson, Emilie K; Broder-Fingert, Sarabeth; Tanpowpong, Pornthep; Bickel, Jonathan; Lightdale, Jenifer R; Nelson, Caleb P

    2014-01-30

    A major aim of the i2b2 (informatics for integrating biology and the bedside) clinical data informatics framework aims to create an efficient structure within which patients can be identified for clinical and translational research projects.Our objective was to describe the respective roles of the i2b2 research query tool and the electronic medical record (EMR) in conducting a case-controlled clinical study at our institution. We analyzed the process of using i2b2 and the EMR together to generate a complete research database for a case-control study that sought to examine risk factors for kidney stones among gastrostomy tube (G-tube) fed children. Our final case cohort consisted of 41/177 (23%) of potential cases initially identified by i2b2, who were matched with 80/486 (17%) of potential controls. Cases were 10 times more likely to be excluded for inaccurate coding regarding stones vs. inaccurate coding regarding G-tubes. A majority (67%) of cases were excluded due to not meeting clinical inclusion criteria, whereas a majority of control exclusions (72%) occurred due to inadequate clinical data necessary for study completion. Full dataset assembly required complementary information from i2b2 and the EMR. i2b2 was critical as a query analysis tool for patient identification in our case-control study. Patient identification via procedural coding appeared more accurate compared with diagnosis coding. Completion of our investigation required iterative interplay of i2b2 and the EMR to assemble the study cohort.

  15. 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.

  16. 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.

  17. 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.

  18. Examinations with computerized cranial axial tomography carried out on patients with epileptic seizures, taking into consideration the EEG and the clinical picture

    International Nuclear Information System (INIS)

    Geiser, R.

    1982-01-01

    204 patients suffering from epileptic seizures were examined with the help of computerized cranial X-ray tomography; the results were compared with anamnestic, clinical, and EEC-findings. In good agreement with results published in literature, in 54% of the patients pathologic CT's such as tumours, attack scars, changes in ventricles and arachnoid spaces etc. were found. A pathological CT is very likely to appear in male patients who are 30 or even 50 years of age, having partial attacks with elementary symptoms, focal diagnosis in the EEG and a neurological unilateral finding. Especially noteworthy is the tumour detecting rate achieved by CT and the fact that in nearly 5% of the cases CT detected a cerebral lesion which has not been suspected, neither clinically nor in the EEG (4 tumours). This shows clearly that CT represents a heighly valuable diagnostic help, especially for patients with epileptic seizures. (orig./MG) [de

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

    Directory of Open Access Journals (Sweden)

    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.

  20. 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.

  1. Clinical and programmatic considerations in the treatment of MDR-TB in children: a series of 16 patients from Lima, Peru.

    Science.gov (United States)

    Mukherjee, J S; Joseph, J K; Rich, M L; Shin, S S; Furin, J J; Seung, K J; Sloutsky, A; Socci, A R; Vanderwarker, C; Vasquez, L; Palacios, E; Guerra, D; Viru, F A; Farmer, P; Del Castillo, H E

    2003-07-01

    Since 2000, the directly observed treatment, short-course (DOTS) strategy has been expanded in several countries to include treatment of multidrug-resistant tuberculosis (MDR-TB). This strategy is known as DOTS-Plus. Tuberculosis is a common cause of morbidity and mortality for children throughout the developing world. Children may also be infected with MDR-TB, yet most developing countries do not specifically address pediatric MDR-TB. To present the intermediate outcomes of the first 16 children enrolled in the Peruvian DOTS-Plus program and to demonstrate the tolerability of second-line anti-tuberculosis drugs. Three children completed therapy and are cured, one child had bacteriologic and clinical failure after 12 months of therapy and died of respiratory insufficiency, and 12 have intermediate outcomes demonstrating favorable clinical, bacteriologic, and radiographic evidence of improvement after 9-19 months of therapy. Of the 16 pediatric DOTS-Plus patients, 15 have tolerated therapy well and have had favorable clinical evolution. However, the diagnosis of pediatric MDR-TB is often extremely delayed due to reliance on the adult case definition and should be changed to prevent progressive, chronic illness in such children. Programmatic changes could facilitate earlier diagnosis and treatment of pediatric MDR-TB in Peru and in other DOTS-Plus programs.

  2. Extraskeletal myxoid chondrosarcoma presenting as an intradural spinal mass: report of a rare clinical presentation with an emphasis on differential diagnostic considerations

    Directory of Open Access Journals (Sweden)

    Priya Rao

    2014-12-01

    Full Text Available Extraskeletal myxoid chondrosarcoma is a rare soft tissue neoplasm that occurs predominantly in the soft tissues of the lower extremities. Herein we present a case of a 29 year old male who presented with bilateral femoral numbness believed to be the result of prior injury to his back. A magnetic resonance imaging revealed a mass in the T4-T5 epidural space compressing the spinal cord. Laminectomy was performed and the lesion removed piecemeal. The pathology specimen consisted of multiple fragments of dura involved by a myxoid neoplasm with a nodular growth pattern. The tumor cells were arranged in anastomosing cords and strands. Individual tumor cells were small, of uniform size and shape, with small hyperchromatic nuclei and scant eosinophilic cytoplasm. Immunohistochemical stains were performed which showed the tumor cells were diffusely positive for vimentin and focally positive for EMA, S-100 protein and cytokeratin, whereas they were negative for CD34 and CD99. Fluorescence in situ hybridization (FISH studies showed a clonal population of cells with re-arrangement of the EWSR1 locus, confirming the histologic impression of extraskeletal myxoid chondrosarcoma. This is the first report of a case of an extraskeletal myxoid chondrosarcoma arising from the dura, confirmed to have rearrangement of the EWSR1 gene by FISH. There have only been two other cases of dural based extraskeletal myxoid chondrosarcoma reported prior to our case. We also briefly review the published literature and discuss differential diagnostic considerations for this rare tumor.

  3. Treatment Considerations for the Cardiometabolic Signs of Polycystic Ovary Syndrome: A Review of the Literature Since the 2013 Endocrine Society Clinical Practice Guidelines.

    Science.gov (United States)

    Fields, Errol L; Trent, Maria E

    2016-05-01

    Polycystic ovary syndrome is characterized by an excess in androgen levels, ovarian dysfunction, and polycystic ovarian morphology but is also associated with metabolic dysfunction and risk factors for cardiovascular disease. To our knowledge, there are few therapeutic recommendations for these cardiometabolic risk factors and little evidence of their long-term clinical relevance to cardiovascular health. To determine metabolic and/or cardiovascular outcomes in polycystic ovary syndrome treatment literature since the publication of the most recent Endocrine Society clinical practice guidelines in 2013. We searched PubMed using a string of variations of polycystic ovary syndrome, therapy/treatment, and adolescence, and we included English-language original research articles published while the 2013 clinical practice guidelines were disseminated (ie, articles published from January 1, 2011, to June 1, 2015). Articles that appeared relevant based on a review of titles and abstracts were read in full to determine relevancy. References from relevant articles were reviewed for additional studies. Four topic areas emerged: (1) lifestyle modification, (2) metformin vs placebo or estrogen-progestin oral contraceptives, (3) insulin-sensitizing agents, and (4) estrogen-progestin formulations. Most studies assessed the role of metformin as a monotherapy or dual therapy supplement and found significant benefit when including metformin in polycystic ovary syndrome treatment regimens. Studies showed improvements in cardiometabolic risk factors and, in several, androgen excess and cutaneous and menstrual symptoms. Studies were limited by sample size (range, 22-171), few adolescent participants, and short-term outcomes. Findings show potential for metformin and estrogen-progestin dual therapy but warrant longitudinal studies examining outcomes from adolescence through middle age to determine the effect on long-term cardiovascular health.

  4. What, why, and when we image: considerations for diagnostic imaging and clinical research in the Children's Oncology Group

    Energy Technology Data Exchange (ETDEWEB)

    Reaman, Gregory H. [The George Washington University, School of Medicine and Health Sciences, Division of Hematology Oncology, Children' s National Medical Center, Washington, DC (United States)

    2009-02-15

    Success in improving treatment outcomes in childhood cancer has been achieved almost exclusively through multicenter and multidisciplinary clinical and applied research over several decades. While biologically rational as well as empirical approaches have led to combination chemotherapy and multimodality approaches to therapy, which have given rise to evidence-based practice standards, similar scientific rigor has not always been as evidently applied to modalities utilized to assess initial disease burden and, more important, response to investigational approaches to therapy. As the empirical approach to therapeutic advances has likely maximized its benefit, future progress will require translation of biologic discovery most notably from the areas of genomics and proteomics. Hence, attempts to improve efficacy of therapy will require a parallel effort to minimize collateral damage of future therapeutic approaches, and such a parallel approach will mandate the continued dependence on advances in diagnostic imaging for improvements in staging methodologies to best define risk groups for risk-adjusted therapy. In addition, anatomic and functional assessment of response and surveillance for disease recurrence will require improved understanding of the biology as well as natural history of individual diseases, which one hopes will better inform investigators in designing trials. Clinical and research expertise is urgently needed in the selection of specific imaging studies and frequencies that best assess a response as well as to define disease-free intervals. Despite limited resources to develop sufficient infrastructure, emphasis on enabling early assessment of new technology to minimize risks associated with treatment advances and with those critical diagnostic and staging procedures must continue to be a focus of pediatric cancer clinical research. (orig.)

  5. Experimental poisoning of goats by Ipomoea carnea subsp. fistulosa in Argentina: a clinic and pathological correlation with special consideration on the central nervous system

    Directory of Open Access Journals (Sweden)

    Elvio E. Ríos

    2012-01-01

    Full Text Available Ipomoea carnea subsp. fistulosa, aguapei or mandiyura, is responsible for lysosomal storage in goats. The shrub contains several alkaloids, mainly swansonine which inhibits lysosomal α-mannosidase and Golgi mannosidase II. Poisoning occurs by inhibition of these hydrolases. There is neuronal vacuolation, endocrine dysfunction, cardiovascular and gastrointestinal injury, and immune disorders. Clinical signs and pathology of the experimental poisoning of goats by Ipomoea carnea in Argentina are here described. Five goats received fresh leaves and stems of Ipomoea. At the beginning, the goats did not consume the plant, but later, it was preferred over any other forage. High dose induced rapid intoxication, whereas with low doses, the course of the toxicosis was more protracted. The goats were euthanized when they were recumbent. Cerebrum, cerebellum, medulla oblongata, pons and colliculi, were routinely processed for histology. In nine days, the following clinical signs developed: abnormal fascies, dilated nostrils and abnormal postures of the head, cephalic tremors and nystagmus, difficulty in standing. Subsequently, the goats had a tendency to fall, always to the left, with spastic convulsions. There was lack in coordination of voluntary movements due to Purkinje and deep nuclei neurons damage. The cochlear reflex originated hyperreflexia, abnormal posture, head movements and tremors. The withdrawal reflex produced flexor muscles hypersensitivity at the four legs, later depression and stupor. Abnormal responses to sounds were related to collicular lesions. Thalamic damage altered the withdrawal reflex, showing incomplete reaction. The observed cervical hair bristling was attributed to a thalamic regulated nociceptive response. Depression may be associated with agonists of lysergic acid contained in Ipomoea. These clinical signs were correlated with lesions in different parts of the CNS.

  6. Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations

    Science.gov (United States)

    Yiadom, Maame Yaa A B; Domenico, Henry; Byrne, Daniel; Hasselblad, Michele Marie; Gatto, Cheryl L; Kripalani, Sunil; Choma, Neesha; Tucker, Sarah; Wang, Li; Bhatia, Monisha C; Morrison, Johnston; Harrell, Frank E; Hartert, Tina; Bernard, Gordon

    2018-01-01

    Introduction Hospital readmissions within 30 days are a healthcare quality problem associated with increased costs and poor health outcomes. Identifying interventions to improve patients’ successful transition from inpatient to outpatient care is a continued challenge. Methods and analysis This is a single-centre pragmatic randomised and controlled clinical trial examining the effectiveness of a discharge follow-up phone call to reduce 30-day inpatient readmissions. Our primary endpoint is inpatient readmission within 30 days of hospital discharge censored for death analysed with an intention-to-treat approach. Secondary endpoints included observation status readmission within 30 days, time to readmission, all-cause emergency department revisits within 30 days, patient satisfaction (measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems scores) and 30-day mortality. Exploratory endpoints include the need for assistance with discharge plan implementation among those randomised to the intervention arm and reached by the study nurse, and the number of call attempts to achieve successful intervention delivery. Consistent with the Learning Healthcare System model for clinical research, timeliness is a critical quality for studies to most effectively inform hospital clinical practice. We are challenged to apply pragmatic design elements in order to maintain a high-quality practicable study providing timely results. This type of prospective pragmatic trial empowers the advancement of hospital-wide evidence-based practice directly affecting patients. Ethics and dissemination Study results will inform the structure, objective and function of future iterations of the hospital’s discharge follow-up phone call programme and be submitted for publication in the literature. Trial registration number NCT03050918; Pre-results. PMID:29444787

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

    Directory of Open Access Journals (Sweden)

    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.

  8. Clinical evaluation of developed product for recovery of immune system in the treatment of cancer patients

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Chul-Ku; Choi, Soo Yong; Rhyu, Sung Ryeol; Kim, Ki Wha; Kim, Ji Yun; Yun, Na Ra [Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of)

    2006-01-15

    We evaluate the clinical efficacy of pilot product (HemoHIM) on recovery from hematopoiesis damage in cancer patients who received radiotherapy and chemotherapy. The cancer patients studied were as follows : cancer of the breast(47 intakers and 136 non-intakers), uterine cervix(38 intakers and 73 non-intakers), and head and neck(7 intakers and 15 non-intakers). The clinical efficacy of pilot product(HemoHIM) in cancer patients who received radiotherapy and chemotherapy was analyzed. In breast cancer patients, the number of leukocytes decreased according to duration of treatment in both groups. However, intakers showed a less decreasing trend compared with non-intakers. Especially, under limiting value in range of leukocyte number of intakers was significantly higher than that of non-intakers. This result incicates that HemoHIM reduce the severe leukopenia. Values of lymphocyte in both groups decreased similarly after treatment, and it was similar to that of leukocyte. Values of erythrocyte in both groups decreased similarly after treatment, but the values were within normal range. In cervix cancer patients, the results were similar to that of breast cancer patients. In cancer of head and neck, values of leukocyte slightly decreased according to duration of treatment in both group. However, it needs to collect more subjects continuously because of small number of cancer patients. No toxicological side effects of HemoHIM were observed in serological analysis, and possibility to alleviate fatigue and inflammation was investigated in some cases.

  9. 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.

  10. 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.

  11. Clinical evaluation of developed product for recovery of immune system in the treatment of cancer patients

    International Nuclear Information System (INIS)

    Cho, Chul-Ku; Choi, Soo Yong; Rhyu, Sung Ryeol; Kim, Ki Wha; Kim, Ji Yun; Yun, Na Ra

    2006-01-01

    We evaluate the clinical efficacy of pilot product (HemoHIM) on recovery from hematopoiesis damage in cancer patients who received radiotherapy and chemotherapy. The cancer patients studied were as follows : cancer of the breast(47 intakers and 136 non-intakers), uterine cervix(38 intakers and 73 non-intakers), and head and neck(7 intakers and 15 non-intakers). The clinical efficacy of pilot product(HemoHIM) in cancer patients who received radiotherapy and chemotherapy was analyzed. In breast cancer patients, the number of leukocytes decreased according to duration of treatment in both groups. However, intakers showed a less decreasing trend compared with non-intakers. Especially, under limiting value in range of leukocyte number of intakers was significantly higher than that of non-intakers. This result incicates that HemoHIM reduce the severe leukopenia. Values of lymphocyte in both groups decreased similarly after treatment, and it was similar to that of leukocyte. Values of erythrocyte in both groups decreased similarly after treatment, but the values were within normal range. In cervix cancer patients, the results were similar to that of breast cancer patients. In cancer of head and neck, values of leukocyte slightly decreased according to duration of treatment in both group. However, it needs to collect more subjects continuously because of small number of cancer patients. No toxicological side effects of HemoHIM were observed in serological analysis, and possibility to alleviate fatigue and inflammation was investigated in some cases

  12. 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.

  13. The clinical trajectory of emerging bipolar disorder among the high-risk offspring of bipolar parents: current understanding and future considerations.

    Science.gov (United States)

    Duffy, A; Vandeleur, C; Heffer, N; Preisig, M

    2017-11-22

    Relatively little is known about the onset of bipolar disorder, yet the early illness course is already associated with significant morbidity and mortality. Therefore, characterizing the bipolar illness trajectory is key to risk prediction and early intervention advancement. In this narrative review, we discuss key findings from prospective longitudinal studies of the high-risk offspring of bipolar parents and related meta-analyses that inform us about the clinical trajectory of emerging bipolar disorder. Challenges such as phenotypic and etiologic heterogeneity and the non-specificity of early symptoms and syndromes are highlighted. Implications of the findings for both research and clinical practice are discussed. Bipolar disorder in young people at familial risk does not typically onset with a hypomanic or manic episode. Rather the first activated episode is often preceded by years of impairing psychopathological states that vary over development and across emerging bipolar subtype. Taking heterogeneity into account and adopting a more comprehensive approach to diagnosis seems necessary to advance earlier identification and our understanding of the onset of bipolar disorder.

  14. Two dimensional echocardiography in mitral, aortic and tricuspid valve prolapse - The clinical problem, cardiac nuclear imaging considerations and a proposed standard for diagnosis

    International Nuclear Information System (INIS)

    Morganroth, J.; Jones, R.H.; Chen, C.C.; Naito, M.; Thomas Jefferson University, Philadelphia, Pa.; Duke University, Medical Center, Durham, N.C.)

    1980-01-01

    The mitral valve prolapse syndrome may present with a variety of clinical manifestations and has proved to be a common cause of nonspecific cardiac symptoms in clinical practice. Primary and secondary forms must be distinguished. Myxomatous degeneration appears to be the common denominator of the primary form. The diagnostic standard of this form has not previously been defined because the detection of mitral leaflet tissue in the left atrium (prolapse) on physical examination or angiography is nonspecific. M mode echocardiography has greatly enhanced the recognition of this syndrome but has not proved to be the best diagnostic standard because of its limited view of mitral valve motion. The advent of two-dimensional echocardiography has provided the potential means for specific identification of the mitral leaflet motion in systole and can be considered the diagnostic standard for this syndrome. Primary myxomatous degeneration with leaflet prolapse is not localized to the mitral valve. Two-dimensional echocardiography has detected in preliminary studies tricuspid valve prolapse in up to 50% and aortic valve prolapse in about 20% of patients with idiopathic mitral valve prolapse

  15. 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

  16. Improving the Adherence to Antiretroviral Therapy, a Difficult but Essential Task for a Successful HIV Treatment—Clinical Points of View and Practical Considerations

    Directory of Open Access Journals (Sweden)

    Simona A. Iacob

    2017-11-01

    Full Text Available HIV infection is responsible for one the most devastating human pandemics. The advent of antiretroviral therapy has changed the course of the pandemic and saved millions of lives. Complex therapeutic regimens have been introduced since 1996 and have contributed to the transformation of HIV infection into a treatable chronic diseases. New types of potent antiretrovirals and their combinations, including “once daily” treatment, have simplified the regimens and diminished side effects. Nevertheless the adherence to antiretroviral therapy remains unsatisfactory and varies between 27 and 80% across different population in various studies, compared with the required level of 95%. The lack of adherence to antiretroviral therapy is a multi-factorial and dynamic process which raises considerable difficulties for long-term follow-up. Current solutions to this problem are complex. These should be applied by a multidisciplinary team and should take into account key features related to both the individual and social factors as well as to the population to whom it belongs (children, teenagers, elderly, marginalized population like drug users, incarcerated patients, sex workers, etc.. Importantly, adherence should continue to be monitored even in patients known to be compliant. In case of subsequent failure the team should identify the reasons for non-adherence and apply the appropriate methods. Where usual methods have no chance of success, a coordinated package of services also known as “harm reduction” can be offered in order to reduce the risks of transmission. The current article analyses the concept of adherence to antiretroviral therapy, the shortcomings of this medication and the methods that can be applied in practice to increase adherence. Emphasis is placed on the analysis of groups at high risk for HIV infection that currently represent the spearhead with which the HIV pandemic is spreading.

  17. 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.

  18. 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.

  19. Contribution of a winter wheat cover crop to the maintenance of Pratylenchus penetrans populations in the raspberry production system with management considerations

    Science.gov (United States)

    One of the primary production challenges red raspberry growers in the Pacific Northwest confront is root lesion nematode (RLN; Pratylenchus penetrans). In this perennial production system, raspberry serves as a sustained host for RLN. When a raspberry planting is slated for removal in the fall, a ne...

  20. 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....

  1. 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.

  2. 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.

  3. Quantitative Analysis of Motor Status in Parkinson’s Disease Using Wearable Devices: From Methodological Considerations to Problems in Clinical Applications

    Directory of Open Access Journals (Sweden)

    Masahiko Suzuki

    2017-01-01

    Full Text Available Long-term and objective monitoring is necessary for full assessment of the condition of patients with Parkinson’s disease (PD. Recent advances in biotechnology have seen the development of various types of wearable (body-worn sensor systems. By using accelerometers and gyroscopes, these devices can quantify motor abnormalities, including decreased activity and gait disturbances, as well as nonmotor signs, such as sleep disturbances and autonomic dysfunctions in PD. This review discusses methodological problems inherent in wearable devices. Until now, analysis of the mean values of motion-induced signals on a particular day has been widely applied in the clinical management of PD patients. On the other hand, the reliability of these devices to detect various events, such as freezing of gait and dyskinesia, has been less than satisfactory. Quantification of disease-specific changes rather than nonspecific changes is necessary.

  4. Cortical thickness in de novo patients with Parkinson disease and mild cognitive impairment with consideration of clinical phenotype and motor laterality.

    Science.gov (United States)

    Danti, S; Toschi, N; Diciotti, S; Tessa, C; Poletti, M; Del Dotto, P; Lucetti, C

    2015-12-01

    Parkinson's disease (PD) is a progressive neurodegenerative disorder with motor and non-motor symptoms, including cognitive deficits. Several magnetic resonance imaging approaches have been applied to investigate brain atrophy in PD. The aim of this study was to detect early structural cortical and subcortical changes in de novo PD whilst distinguishing cognitive status, clinical phenotype and motor laterality. Eighteen de novo PD with mild cognitive impairment (PD-MCI), 18 de novo PD without MCI (PD-NC) and 18 healthy control subjects were evaluated. In the PD-MCI group, nine were tremor dominant and nine were postural instability gait disorder (PIGD) phenotype; 11 had right-sided symptom dominance and seven had left-sided symptom dominance. FreeSurfer was used to measure cortical thickness/folding, subcortical structures and to study group differences as well as the association with clinical and neuropsychological data. Parkinson's disease with MCI showed regional thinning in the right frontal, right middle temporal areas and left insula compared to PD-NC. A reduction of the volume of the left and right thalamus and left hippocampus was found in PD-MCI compared to PD-NC. PD-MCI PIGD showed regional thinning in the right inferior parietal area compared to healthy controls. A decreased volume of the left thalamus was reported in PD-MCI with right-sided symptom dominance compared to PD-NC and PD-MCI with left-sided symptom dominance. When MCI was present, PD patients showed a fronto-temporo-parietal pattern of cortical thinning. This cortical pattern does not appear to be influenced by motor laterality, although one-sided symptom dominance may contribute to volumetric reduction of specific subcortical structures. © 2015 EAN.

  5. Considerações sobre as significações da psicologia clínica na contemporaneidade Considerations on the meanings of clinical psychology in our times

    Directory of Open Access Journals (Sweden)

    Elza Dutra

    2004-08-01

    Full Text Available Este artigo considera a evolução de significados e conceitos da Psicologia Clínica e suas implicações para as ações do psicólogo dessa área. Para isso baseia-se no pensamento fenomenológico e nas idéias de alguns estudiosos da psicologia, na tentativa de melhor compreender as mudanças ocorridas nos saberes e fazeres do psicólogo clínico. A análise empreendida confirma a importância do compromisso social do psicólogo na sua prática e sugere que a postura clínica repousa não só na formação teórico-técnica, mas, sobretudo, na ética da escuta do não-dito e do interditado.The aim of this article is to discuss the evolution of the meanings and concepts of Clinical Psychology and its implication for the psychologists in this area. The discussion is based on the concepts of the phenomenological approach and the ideas of authors in Psychology and leads to a better understanding of the changes that have taken place on psychological knowledge and practices. Such analysis points to the relevance of social commitment from the clinical psychologist and suggests that the accomplishment of his work lies not only on a proper theoretical and technical knowledge, but above all on an ethical attitude regarding the listening of what is unsaid and censored.

  6. Clinical course of brain stroke in the persons exposed to ionizing radiation under the production conditions

    International Nuclear Information System (INIS)

    Bouchmanov, A.

    2000-01-01

    The purpose was to study the risk factors and clinical course of brain strokes in professionally exposed workers being employed in plutonium production in comparison with a control group. The method and materials of study -clinical supervision and clinical database creation on 162 cases of brain stroke (128 males and 34 females) developed among professionally exposed workers. Age of patient varied from 21 to 68 years (in average -51.6 y.). The control group consisted of patients with the same diagnosis, worked on the same enterprise, but non-exposed to radiation. Data on the totally accumulated dose of external gamma radiation were received on the base of the individual dosimeters (from 0.1 cSv to 52 cSv, in average about 13 cSv); the plutonium-239 body content was estimated accordingly to the level of urine radionuclide excretion (from 0.4 kBq to 1.6 kBq, in average about 0.33 kBq). Muscle's hypertinsion and pathological great-toe reflexes in paretic legs and hands, hemianopsia, impressive and ataxic aphasia prevailed in the patients with ischemic brain strokes in system of internal carotid artery, exposed to radiation. The changes of muscle's tension, ataxia and nystagmus were marked more often in the professionals with ischemic brain strokes in system of vertebrobasilar artery. The illness proceeded more easy and with smaller frequency of frustration of consciousness and algesthesia, irrespective of a type ischemic brain strokes in the people exposed to ionizing radiation, than in patients of non-irradiated group. It was found that the arterial hypertension appeared to be the main risk factor for the brain stroke in both groups of patients (in 81.48% and 91.15% of cases). There was no marked differences in significance of risk factors and in main clinical parameters of various types of ischemic brain strokes among the patients professionally exposed to radiation in comparison with a control group. (author)

  7. Clinical trial registries: a practical guide for sponsors and researchers of medicinal products

    National Research Council Canada - National Science Library

    Foote, MaryAnn

    2006-01-01

    ... Industry perspective on public clinical trial registries and results databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...

  8. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  10. Case Report: Diagnosis of hypogeusia after oral exposure to commercial cleaning agent and considerations for clinical taste testing [version 2; referees: 2 approved, 1 not approved

    Directory of Open Access Journals (Sweden)

    Marie Jetté

    2017-06-01

    Full Text Available Few reports in the literature document acute taste disturbance following exposure to toxic chemicals. We describe the case of a 54-year-old man who presented with primary complaint of tongue numbness and persistent problems with taste 1.5 years following oral exposure to a commercial cleaning agent. A test of olfaction revealed normosmia for age and gender. Lingual tactile two-point discrimination testing showed reduced somatosensation. Taste threshold testing using a 3-drop method demonstrated severe hypogeusia, though the patient was able to discriminate tastants at lower concentrations with a whole mouth swish and spit test. We conclude that clinical evaluation of dysgeusia can be performed using a number of previously published testing methods, however, determining causative factors may be confounded by duration since exposure, lack of knowledge of baseline taste function, and medications. Although many testing options exist, basic taste testing can be performed with minimal expertise or specialized equipment, depending on the patient history and goals of evaluation.

  11. The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients.

    Science.gov (United States)

    Mauri Llerda, J A; Suller Marti, A; de la Peña Mayor, P; Martínez Ferri, M; Poza Aldea, J J; Gomez Alonso, J; Mercadé Cerdá, J M

    2015-10-01

    The characteristics of some population groups (patients with comorbidities, women of childbearing age, the elderly) may limit epilepsy management. Antiepileptic treatment in these patients may require adjustments. We searched articles in Pubmed, clinical practice guidelines for epilepsy, and recommendations by the most relevant medical societies regarding epilepsy in special situations (patients with comorbidities, women of childbearing age, the elderly). Evidence and recommendations are classified according to the prognostic criteria of Oxford Centre of Evidence-Based Medicine (2001) and the European Federation of Neurological Societies (2004) for therapeutic interventions. Epilepsy treatment in special cases of comorbidities must be selected properly to improve efficacy with the fewest side effects. Adjusting antiepileptic medication and/or hormone therapy is necessary for proper seizure management in catamenial epilepsy. Exposure to antiepileptic drugs (AED) during pregnancy increases the risk of birth defects and may affect fetal growth and/or cognitive development. Postpartum breastfeeding is recommended, with monitoring for adverse effects if sedative AEDs are used. Finally, the elderly are prone to epilepsy, and diagnostic and treatment characteristics in this group differ from those of other age groups. Although therapeutic limitations may be more frequent in older patients due to comorbidities, they usually respond better to lower doses of AEDs than do other age groups. Copyright © 2014 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

  12. Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial

    Directory of Open Access Journals (Sweden)

    Griffiths Frances E

    2007-02-01

    Full Text Available Abstract Background Low back pain (LBP is a major public health problem. Risk factors for the development and persistence of LBP include physical and psychological factors. However, most research activity has focused on physical solutions including manipulation, exercise training and activity promotion. Methods/Design This randomised controlled trial will establish the clinical and cost-effectiveness of a group programme, based on cognitive behavioural principles, for the management of sub-acute and chronic LBP in primary care. Our primary outcomes are disease specific measures of pain and function. Secondary outcomes include back beliefs, generic health related quality of life and resource use. All outcomes are measured over 12 months. Participants randomised to the intervention arm are invited to attend up to six weekly sessions each of 90 minutes; each group has 6–8 participants. A parallel qualitative study will aid the evaluation of the intervention. Discussion In this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain.

  13. Improving email strategies to target stress and productivity in clinical practice.

    Science.gov (United States)

    Armstrong, Melissa J

    2017-12-01

    Physician burnout is gaining increased attention in medicine and neurology and often relates to hours worked and insufficient time. One component of this is administrative burden, which relates to regulatory requirements and electronic health record tasks but may also involve increased time spent processing emails. Research in academic medical centers demonstrates that physicians face increasing inbox sizes related to mass distribution emails from various sources on top of emails required for patient care, research, and teaching. This commentary highlights the contribution of administrative tasks to physician burnout, research to date on email in medical contexts, and corporate strategies for reducing email burden that are applicable to neurology clinical practice. Increased productivity and decreased stress can be achieved by limiting the amount one accesses email, managing inbox size, and utilizing good email etiquette. Department and practice physician leaders have roles in decreasing email volume and modeling good practice.

  14. Two to five repeated measurements per patient reduced the required sample size considerably in a randomized clinical trial for patients with inflammatory rheumatic diseases

    Directory of Open Access Journals (Sweden)

    Smedslund Geir

    2013-02-01

    Full Text Available Abstract Background Patient reported outcomes are accepted as important outcome measures in rheumatology. The fluctuating symptoms in patients with rheumatic diseases have serious implications for sample size in clinical trials. We estimated the effects of measuring the outcome 1-5 times on the sample size required in a two-armed trial. Findings In a randomized controlled trial that evaluated the effects of a mindfulness-based group intervention for patients with inflammatory arthritis (n=71, the outcome variables Numerical Rating Scales (NRS (pain, fatigue, disease activity, self-care ability, and emotional wellbeing and General Health Questionnaire (GHQ-20 were measured five times before and after the intervention. For each variable we calculated the necessary sample sizes for obtaining 80% power (α=.05 for one up to five measurements. Two, three, and four measures reduced the required sample sizes by 15%, 21%, and 24%, respectively. With three (and five measures, the required sample size per group was reduced from 56 to 39 (32 for the GHQ-20, from 71 to 60 (55 for pain, 96 to 71 (73 for fatigue, 57 to 51 (48 for disease activity, 59 to 44 (45 for self-care, and 47 to 37 (33 for emotional wellbeing. Conclusions Measuring the outcomes five times rather than once reduced the necessary sample size by an average of 27%. When planning a study, researchers should carefully compare the advantages and disadvantages of increasing sample size versus employing three to five repeated measurements in order to obtain the required statistical power.

  15. Dosimetric considerations and early clinical experience of accelerated partial breast irradiation using multi-lumen applicators in the setting of breast augmentation

    Science.gov (United States)

    Akhtari, Mani; Pino, Ramiro; Scarboro, Sarah B.; Bass, Barbara L.; Miltenburg, Darlene M.; Butler, E. Brian

    2015-01-01

    Purpose Accelerated partial breast irradiation (APBI) is an accepted treatment option in breast-conserving therapy for early stage breast cancer. However, data regarding outcomes of patients treated with multi-lumen catheter systems who have existing breast implants is limited. The purpose of this study was to report treatment parameters, outcomes, and possible dosimetric correlation with cosmetic outcome for this population of patients at our institution. Material and methods We report the treatment and outcome of seven consecutive patients with existing breast implants and early stage breast cancer who were treated between 2009 and 2013 using APBI following lumpectomy. All patients were treated twice per day for five days to a total dose of 34 Gy using a high-dose-rate 192Ir source. Cosmetic outcomes were evaluated using the Harvard breast cosmesis scale, and late toxicities were reported using the Radiation Therapy Oncology Group (RTOG) late radiation morbidity schema. Results After a mean follow-up of 32 months, all patients have remained cancer free. Six out of seven patients had an excellent or good cosmetic outcome. There were no grade 3 or 4 late toxicities. The average total breast implant volume was 279.3 cc, received an average mean dose of 12.1 Gy, and a maximum dose of 234.1 Gy. The average percentage of breast implant volume receiving 50%, 75%, 100%, 150%, and 200% of the prescribed dose was 15.6%, 7.03%, 4.6%, 1.58%, and 0.46%, respectively. Absolute volume of breast implants receiving more than 50% of prescribed dose correlated with worse cosmetic outcomes. Conclusions Accelerated partial breast irradiation using a multi-lumen applicator in patients with existing breast implants can safely be performed with promising early clinical results. The presence of the implant did not compromise the ability to achieve dosimetric criteria; however, dose to the implant and the irradiated implant volume may be related with worse cosmetic outcomes. PMID:26816499

  16. Diagnosis of osteoporosis in rural Arctic Greenland: a clinical case using plain chest radiography for secondary prevention and consideration of tools for primary prevention in remote areas.

    Science.gov (United States)

    Fleischer, Inuuteq; Schæbel, Louise K; Albertsen, Nadja; Sørensen, Vibeke N; Andersen, Stig

    2017-01-01

    Osteoporosis is a frequent disease in many populations. The hallmark is fragility fractures, which are harbingers of future fractures, disability, mortality and cost on society. The occurrence increases with age, low vitamin D level and smoking. Smoking rates are high, vitamin D is low and life expectancy is rising steeply in Greenland, as is the need for focus on osteoporosis. We report a case that uses a simple and readily available tool to diagnose osteoporosis at the hospital in Sisimiut, a town of 5000 inhabitants on the west coast of Greenland. A 51-year-old Inuit woman was seen due to lower back pain. No trauma could be recalled. Laboratory results showed a low vitamin D level and normal S-calcium, S-phosphate, S-parathyroid hormone, S-thyrotropin, erythrocyte sedimentation rate, S-creatinine and hemoglobin. The lateral chest radiograph demonstrated a reduction of anterior height of the seventh and ninth thoracic vertebral bodies of 50% and 40% respectively. Chest radiographs are frequently done in the towns along the vast coastline of Greenland, the world's largest island. They are transferred to the hospital in the capital city Nuuk using existing tele-technology, and specialist evaluations are given in electronic records available at the coastal hospitals. Effective therapies for osteoporosis are available and the identification of vertebral fractures that merit treatment may prevent future fractures, morbidity and mortality. Fragility fractures are frequent in old age and the steep rise in life expectancy and in the number of old people in Greenland emphasize the need for a focus on management of osteoporosis. Geography provides a diagnostic challenge to rural and remote areas that can be overcome by the use of lateral chest radiographs as it relies on facilities readily available. Clinical risk assessment tools with high specificity may support further osteoporosis risk prediction in remote Arctic societies.

  17. Speciation and Biofilm Production of Coagulase Negative Staphylococcal Isolates from Clinically Significant Specimens and their Antibiogram

    Directory of Open Access Journals (Sweden)

    S. S. Vijayasri Badampudi

    2016-04-01

    Full Text Available Background: Coagulase Negative Staphylococci (CONS are increasingly recognized as significant nosocomial pathogens. Their ability of biofilm formation and multiple drug resistance are causing serious human infections. Aim and Objectives: To isolate, identify, speciate clinically significant CONS from various specimens, to study antibiotic resistance pattern and biofilm production. Material and Methods: Specimens were collected aseptically, processed and identified upto the species level by a simple scheme of tests urease, novobiocin resistance, mannose and mannitol fermentation, ornithine decarboxylase. Antibiotic sensitivity was done with special reference to methicillin resistance. Biofilm formation was detected by Congo Red Agar (CRA method and Tube Method (TM. Results: Study groupOf 100 isolates majority were pus (40, followed by urine (28, blood (16, CSF (5, body fluids (4 and catheter tips and implants (7. The most common species isolated was S. epidermidis (40% followed by S. haemolyticus (26%, S. saprophyticus (15%, S. schleiferi (13%, S. simulans (2%, S. cohnii (2% and S. warneri and S. capitis each 1%. Resistance to penicillin was 91% followed by ampicillin (79%, cotrimoxazole (67%. Methicillin resistance was 72%. Biofilm producers were 69% by CRAmethod and 33% by TM with majority species S. epidermidis (82.5%- CRA and 55%-TM. Biofilm production was significantly associated with MRCONS (p value 0.0036. Control group-Of 30 isolates were S. epidermidis 66.6% followed by S. haemolyticus (16.66%. Biofilm producers were 53.33% by CRA method and 26.65% by TM with majority species S. epidermidis (65%-CRA and 30%-TM.Methicillin resistance was 26.6%. Conclusion: Clinical significance of CONS is increasing day by day, so there is a need for accurate identification to species level and their antibiogram to avoid multidrug resistance. Biofilm producing CONS species pose a risk and CRA method for screening biofilm can be used in all conventional

  18. Lutetium-177 - Broad Production Capabilities are Expected to Stimulate Clinical Applications of this Important Therapeutic Radioisotope

    International Nuclear Information System (INIS)

    Knapp, F.F. Jr.

    2009-01-01

    though the effort and expense increase exponentially as higher levels of nca Lu-177 are required, with more experience, these methods would be expected to be optimized and automated. Effective clinical results of targeted therapy exemplified with Lu-177-DOTAT-TOC and other peptides have been widely reported for neuroendocrine tumors. For this application, SA of probably > 10 Ci/mg is required. For arthritis therapy with Lu-177-EDTMP, much lower SA is sufficient (∼ 0.5 Ci Lu-177/mg). Although not yet realized, the unique opportunity to produce high activity levels/high SA Lu-177 essentially anywhere in the world would be expected to catalyze broader clinical use of Lu-177. In fact, this is a unique situation where production capabilities for both HSA and LSA Lu-177 far exceed current demand. The goals of this presentation are to discuss the issues associated with the routine production and processing of high activity levels of lutetium-177 and current and expected clinical applications. Research at the Oak Ridge National Laboratory (ORNL) is supported by the U.S. Department of Energy (DOE) under contract DE-AC05-00OR22725 with UT-Battelle, LLC. 'The submitted manuscript has been authored by a contractor of the U.S. Government under contract DE-AC05-00OR22725. Accordingly, the U.S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or allow others to do so, for U.S. Government purposes.' (author)

  19. 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

  20. Cost-benefit considerations in the development of policies and procedures for controlling indoor exposure to radon and its decay products

    International Nuclear Information System (INIS)

    Puskin, J.S.; Guimond, R.J.; Napolitano, S.; Nelson, C.B.

    1989-01-01

    The applicability of ALARA to the problem of controlling residential radon levels is limited. Cost-benefit considerations can nevertheless be useful in guiding policy in this area. From a societal perspective, the cost-benefit balance for mitigating radon in homes to the EPA action level of 4 pCi/L, or lower, is generally better than for most programs aimed at reducing environmental risks. Reduction of radon levels in new homes tends to be less costly; moreover, reduced radon levels in new construction may be achievable with a net cost savings to the homeowner due to concomitant decreases in energy expenses. Since programs to reduced radon exposure rely on voluntary actions by homeowners, the societal cost-benefit balance cannot dictate the extent of radon mitigation efforts. However, both economic incentives and governmental guidance can influence these efforts. Cost-benefit analysis can be an important tool in formulating such guidance

  1. Some practical and theoretical considerations of personal alpha-particle dosimetry. Joint panel on occupational and environmental research for uranium production in Canada (JP-2)

    International Nuclear Information System (INIS)

    Bigu, J.

    1989-01-01

    The status of personal α-particle dosimetry in the uranium industry is presented. A brief description of personal dosimeters and prototypes is followed by some theoretical considerations regarding their practical use under steady-state and time-dependent field conditions. It is suggested that, at present, more effort should be placed on the evaluation of dosimeters than in the development of new ones. Also, more information should be gathered from countries which use personal α-particle dosimeters routinely. Furthermore, emphasis is recommended on comparison of personal dosimetry data with experimental data by area monitoring, using continuous monitoring systems, as well as with data by grab-sampling techniques. (author). 44 refs., 1 tab

  2. Some practical and theoretical considerations of personal alpha-particle dosimetry. Joint panel on occupational and environmental research for uranium production in Canada (JP-2)

    Energy Technology Data Exchange (ETDEWEB)

    Bigu, J [Department of Energy, Mines and Resources, Elliot Lake, ON (Canada). Elliot Lake Lab.; Duport, P [Atomic Energy Control Board, Ottawa, ON (Canada)

    1990-12-31

    The status of personal {alpha}-particle dosimetry in the uranium industry is presented. A brief description of personal dosimeters and prototypes is followed by some theoretical considerations regarding their practical use under steady-state and time-dependent field conditions. It is suggested that, at present, more effort should be placed on the evaluation of dosimeters than in the development of new ones. Also, more information should be gathered from countries which use personal {alpha}-particle dosimeters routinely. Furthermore, emphasis is recommended on comparison of personal dosimetry data with experimental data by area monitoring, using continuous monitoring systems, as well as with data by grab-sampling techniques. (author). 44 refs., 1 tab.

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

    Science.gov (United States)

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

    2016-06-01

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

  4. 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.

  5. [Analysis of scientific production and bibliometric impact of a group of Spanish clinical researchers].

    Science.gov (United States)

    Miró, O; Burbano Santos, P; Trilla, A; Casademont, J; Fernandez Pérez, C; Martín-Sánchez, Fj

    2016-01-01

    To study the behaviour of several indicators of scientific production and repercussion in a group of Spanish clinical researchers and to evaluate their possible utility for interpreting individual or collective scientific pathways. We performed a unicentric, ecological pilot study involving a group of physicians with consolidated research experience. From the Science Citation Index Expanded (SCI-Expanded) database, we obtained the number of publications of each author (indicator of production) and the number of citations, impact factor and h index (indicators of repercussion). These indicators were calculated individually for each of the years of research experience and we assessed the relationship between the experience of the researcher and the value of the indicator achieved, the relationship between these indicators themselves, and their temporal evolution, both individually and for the entire group. We analysed 35 researchers with a research experience of 28.4 (9.6) years. The h index showed the lowest coefficient of variance. The relationship between the indicators and research experience was significant, albeit modest (R2 between 0.15-0.22). The 4 indicators showed good correlations. The temporal evolution of the indicators, both individual and collective, adjusted better to a second grade polynomial than a linear function: individually, all the authors obtained R2>0.90 in all the indicators; together the best adjustment was produced with the h index (R2=0.61). Based on the indicator used, substantial variations may be produced in the researchers' ranking. A model of the temporal evolution of the indicators of production and repercussion can be described in a relatively homogeneous sample of researchers and the h index seems to demonstrate certain advantages compared to the remaining indicators. This type of analysis could become a predictive tool of performance to be achieved not only for a particular researcher, but also for a homogeneous group of resear

  6. [Salary and clinical productivity among physicians in Norwegian somatic hospitals 2001-2008].

    Science.gov (United States)

    Johannessen, Karl-Arne

    2010-09-23

    Analysis of the future need for medical doctors necessitates an assessment of their productivity. The goals of this study were to analyze the relation between doctors' work force and the increased activity in hospitals, and to describe the development of working hours and salary for hospital doctors in a gender perspective. Information about man-labour years, working time and salary for doctors in Norwegian somatic hospitals was retrieved for the period 2001-2008. Number of hospital stays, DRG points and outpatient consultations per man-labour year are used as measures of doctors' clinical productivity. The percentage of female doctors increased from 34.7 % to 42.2 %. The mean annual salary increased more for men (14.4 % higher in 2001 and 16.6 % higher in 2008) than women. Total salary costs for doctors increased by 69.9 % (from 3.66 bill to 6.22 bill. NOK); 42.6 % of this increase was generated by new positions (1 306 man-labour years, + 21.2 %). Labour years from extended working hours increased by 6.8 % (constituting 1043 labour years in 2008; 12.2 % of the total), but the average extended labour time per doctor decreased (-16.7 % for women and -9.6 % for men). The number of hospital stays increased by 13.2 %, DRG points increased by 12.4 % and outpatient consultations increased by 9.3 % per doctor's work year in the period 2001-2008. Higher salaries for men may be explained by age, more men in senior positions and longer working hours than for women. The productivity of Norwegian doctors still increased from 2001 to 2008 (taking into account the increase in salary).

  7. 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.

  8. Epigenetic considerations in aquaculture

    Directory of Open Access Journals (Sweden)

    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.

  9. Clinical course of brain stroke in the persons exposed to ionizing radiation under the production conditions

    Energy Technology Data Exchange (ETDEWEB)

    Bouchmanov, A. [State Research Center of Russia, Moscow (Russian Federation). Inst. of Biophysics

    2000-05-01

    The purpose was to study the risk factors and clinical course of brain strokes in professionally exposed workers being employed in plutonium production in comparison with a control group. The method and materials of study -clinical supervision and clinical database creation on 162 cases of brain stroke (128 males and 34 females) developed among professionally exposed workers. Age of patient varied from 21 to 68 years (in average -51.6 y.). The control group consisted of patients with the same diagnosis, worked on the same enterprise, but non-exposed to radiation. Data on the totally accumulated dose of external gamma radiation were received on the base of the individual dosimeters (from 0.1 cSv to 52 cSv, in average about 13 cSv); the plutonium-239 body content was estimated accordingly to the level of urine radionuclide excretion (from 0.4 kBq to 1.6 kBq, in average about 0.33 kBq). Muscle's hypertinsion and pathological great-toe reflexes in paretic legs and hands, hemianopsia, impressive and ataxic aphasia prevailed in the patients with ischemic brain strokes in system of internal carotid artery, exposed to radiation. The changes of muscle's tension, ataxia and nystagmus were marked more often in the professionals with ischemic brain strokes in system of vertebrobasilar artery. The illness proceeded more easy and with smaller frequency of frustration of consciousness and algesthesia, irrespective of a type ischemic brain strokes in the people exposed to ionizing radiation, than in patients of non-irradiated group. It was found that the arterial hypertension appeared to be the main risk factor for the brain stroke in both groups of patients (in 81.48% and 91.15% of cases). There was no marked differences in significance of risk factors and in main clinical parameters of various types of ischemic brain strokes among the patients professionally exposed to radiation in comparison with a control group. (author)

  10. 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.

  11. 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.

  12. The interaction between milk and beef production and emissions from land use change – critical considerations in life cycle assessment and carbon footprint studies of milk

    DEFF Research Database (Denmark)

    Flysjö, Anna Maria; Cederberg, Christel; Henriksson, Maria

    2012-01-01

    Two most critical factors to address in environmental system analysis of future milk production are 1) the link between milk and beef production, and 2) the competition for land, possibly leading to land use change (LUC) with greenhouse gas (GHG) emissions and loss of biodiversity as important...... is investigated for 23 dairy farms (both organic and conventional) in Sweden. Use of a fixed allocation factor of 90% (based on economic value) indicates a reduction in CF with increased milk yield, while no correlation can be noted when system expansion is applied. The average CF for two groups of farms, organic...... and high yielding conventional, is also calculated. When conducting system expansion the CF is somewhat lower for the organic farms (which have a lower milk yield per cow, but more meat per kg milk), but when a 90% allocation factor is used, the CF is somewhat higher for the organic farms compared...

  13. Material recycling of post-consumer polyolefin bulk plastics: Influences on waste sorting and treatment processes in consideration of product qualities achievable.

    Science.gov (United States)

    Pfeisinger, Christian

    2017-02-01

    Material recycling of post-consumer bulk plastics made up of polyolefins is well developed. In this article, it is examined which effects on waste sorting and treatment processes influence the qualities of polyolefin-recyclats. It is shown that the properties and their changes during the product life-cycle of a polyolefin are defined by its way of polymerisation, its nature as a thermoplast, additives, other compound and composite materials, but also by the mechanical treatments during the production, its use where contact to foreign materials is possible and the waste sorting and treatment processes. Because of the sum of the effects influencing the quality of polyolefin-recyclats, conclusions are drawn for the material recycling of polyolefins to reach high qualities of their recyclats. Also, legal requirements like the EU regulation 1907/2006 concerning the registration, evaluation, authorisation and restrictions on chemicals are considered.

  14. CONSIDERATIONS ON ROMANIA’S AGRO-FOOD EXPORT AND IMPORT BY EUROPEAN UNION COUNTRY GROUP AND AGRO-FOOD PRODUCT GROUP

    Directory of Open Access Journals (Sweden)

    Agatha POPESCU

    2013-10-01

    Full Text Available The goal of the paper was the analysis of Romania’s the agro-food export, import and trade balance by the EU country group and agro-food product group based on the statistical data in the year 2010 in order to identify the commercial relationships with a positive and respectively a negative impact of the trade balance. The EU trade partners were divided into 4 groups: Central Eastern (CE, Western (W, Northern (N and Southern (S EU countries and the agro-food product groups were: Live animals and preparations of animal origin, Vegetal products, Fats and oils of vegetal and animal origin, Food, beverages and tobacco. The data were processed using the share and comparison methods. In 2010, Romania registered a negative agro-food trade balance with a deficit of Euro thousand 903,148.This was due to the unefficient commerce with the CE and W EU countries, which together recorded Euro Thousand 1,400,298 deficit. The balance was positively influenced by the Southern EU trade partners whose contribution accounted for Euro thousand 513,953. Therefore, the agro-food trade has to be intensified with the Southern EU countries and to become more relaxed with the CE and W EU countries, especially regarding imports. Live animals are mainly required in the CE and W EU countries, vegetal products in the W and S EU countries, fats and oils in the CE and S EU countries, and finally, food, beverages and tobacco in the S and the CE EU countries. Agro-food imports have to be substantially diminished as long as Romania’ s agriculture is able to produce for the internal market and export has to be intensified especially with the countries with a positive impact on the trade balance.

  15. PCR screening reveals considerable unexploited biosynthetic potential of ansamycins and a mysterious family of AHBA-containing natural products in actinomycetes.

    Science.gov (United States)

    Wang, H-X; Chen, Y-Y; Ge, L; Fang, T-T; Meng, J; Liu, Z; Fang, X-Y; Ni, S; Lin, C; Wu, Y-Y; Wang, M-L; Shi, N-N; He, H-G; Hong, K; Shen, Y-M

    2013-07-01

    Ansamycins are a family of macrolactams that are synthesized by type I polyketide synthase (PKS) using 3-amino-5-hydroxybenzoic acid (AHBA) as the starter unit. Most members of the family have strong antimicrobial, antifungal, anticancer and/or antiviral activities. We aimed to discover new ansamycins and/or other AHBA-containing natural products from actinobacteria. Through PCR screening of AHBA synthase gene, we identified 26 AHBA synthase gene-positive strains from 206 plant-associated actinomycetes (five positives) and 688 marine-derived actinomycetes (21 positives), representing a positive ratio of 2·4-3·1%. Twenty-five ansamycins, including eight new compounds, were isolated from six AHBA synthase gene-positive strains through TLC-guided fractionations followed by repeated column chromatography. To gain information about those potential ansamycin gene clusters whose products were unknown, seven strains with phylogenetically divergent AHBA synthase genes were subjected to fosmid library construction. Of the seven gene clusters we obtained, three show characteristics for typical ansamycin gene clusters, and other four, from Micromonospora spp., appear to lack the amide synthase gene, which is unusual for ansamycin biosynthesis. The gene composition of these four gene clusters suggests that they are involved in the biosynthesis of a new family of hybrid PK-NRP compounds containing AHBA substructure. PCR screening of AHBA synthase is an efficient approach to discover novel ansamycins and other AHBA-containing natural products. This work demonstrates that the AHBA-based screening method is a useful approach for discovering novel ansamycins and other AHBA-containing natural products from new microbial resources. Journal of Applied Microbiology © 2013 The Society for Applied Microbiology.

  16. The new production theory for health care through clinical reengineering: a study of clinical guidelines--Part I.

    Science.gov (United States)

    Sharp, J R

    1994-12-01

    Drucker writes that the emerging theory of manufacturing includes four principles and practices: statistical quality control, manufacturing accounting, modular organization, and systems approach. SQC is a rigorous, scientific method of identifying variation in the quality and productivity of a given production process, with an emphasis on improvement. The new manufacturing economics intends to integrate the production strategy with the business strategy in order to account for the biggest portions of costs that the old methods did not assess: time and automation. Production operations that are both standardized and flexible will allow the organization to keep up with changes in design, technology, and the market. The return on innovation in this environment is predicated on a modular arrangement of flexible steps in the process. Finally, the systems approach sees the entire process as being integrated in converting goods or services into economic satisfaction. There is now a major restructuring of the U.S. health care industry, and the incorporation of these four theories into health care reform would appear to be essential. This two-part article will address two problems: Will Drucker's theories relate to health care (Part I)? Will the "new manufacturing" in health care (practice guidelines) demonstrate cost, quality, and access changes that reform demands (Part II)?

  17. Considerations on the production and the Principles of the State Considerações entre a produção e os fundamentos do Estado

    Directory of Open Access Journals (Sweden)

    Adreana Dulcina Platt

    2009-12-01

    Full Text Available The aim of this article is the presentation of the partial results of an academic research developed in the State University of Londrina, whose objective was the retrieval of the formation of the State, mainly concerning the guarantee of private property and the taxation of social citizens. Based on the severe westernization of the theory of the State, guided by historical descriptions of production, interchange and technology, this paper will present a descriptive picture of the formation of the State in different historical times, always focusing on the realignment of the production model. The picture will be descriptive and constituted by the focus on the central nations (from pre-capitalist to neoliberal State and on the peripheral nations (metropolitan to neoliberal State. With the explanation of these categories, the study will indicate the determinant policies present in current times in face of the adequacies that need to be made in the relation between the production mode (with emphasis on the hegemony of the capitalist production mode and the State.A finalidade deste artigo se volta a socialização dos resultados parciais da pesquisa acadêmica desenvolvida na Universidade Estadual de Londrina, que objetiva ao resgate da formação do Estado, precipuamente à garantia da propriedade privada e na tributação dos sujeitos sociais. Com a aguda ocidentalização da teoria de Estado orientado pelos determinantes históricos da produção, intercâmbio e tecnologia, partiremos junto a organização de um quadro descritivo da formação do Estado, em diferentes tempos históricos sempre em atenção ao realinhamento do modelo de produção. O quadro será descritivo e composto a partir do enfoque das nações centrais (do Estado pré-capitalista ao Estado neoliberal e das nações periféricas (Estado metropolitano ao Estado neoliberal. Com o esclarecimento destas categorias, apontaremos os determinantes políticos que se fazem presentes na

  18. Nitrogen-rich higher-molecular soil organic compounds patterned by lignin degradation products: Considerations on the nature of soil organic nitrogen

    Science.gov (United States)

    Liebner, Falk; Bertoli, Luca; Pour, Georg; Klinger, Karl; Ragab, Tamer; Rosenau, Thomas

    2016-04-01

    The pathways leading to accumulation of covalently bonded nitrogen in higher-molecular soil organic matter (SOM) are still a controversial issue in soil science and geochemistry. Similarly, structural elucidation of the variety of the types of nitrogenous moieties present in SOM is still in its infancy even though recent NMR studies suggest amide-type nitrogen to form the majority of organically bonded nitrogen which is, however, frequently not in accordance with the results of wet-chemical analyses. Following the modified polyphenol theory of Flaig and Kononova but fully aware of the imperfection of a semi-abiotic simulation approach, this work communicates the results of a study that investigated some potential nitrogen accumulation pathways occurring in the re-condensation branch of the theory following the reactions between well-known low-molecular lignin and carbohydrate degradation products with nitrogenous nucleophiles occurring in soils under aerobic conditions. Different low-molecular degradation products of lignin, cellulose, and hemicellulose, such as hydroquinone, methoxyhydroquinone, p-benzoquinone, 2,5-dihydroxy-[1,4]benzoquinone, glucose, xylose, and the respective polysaccharides, i.e. cellulose, xylan as well as various types of lignin were subjected to a joint treatment with oxygen and low-molecular N-nucleophiles, such as ammonia, amines, and amino acids in aqueous conditions, partly using respective 15N labeled compounds for further 15N CPMAS NMR studies. Product mixtures derived from mono- and polysaccharides have been comprehensively fractionated and analyzed by GC/MS after derivatization. Some of ammoxidized polyphenols and quinones have been analyzed by X-ray photoelectron spectroscopy. Some products, such as those obtained from ammoxidation of methoxy hydroquinone using 15N labeled ammonia were fractionated following the IHSS protocol. Individual humin (H), humic acid (HA), and fulvic acid (FA) fractions were subjected to elemental analyses

  19. Clinical considerations for regenerative endodontic procedures.

    Science.gov (United States)

    Geisler, Todd M

    2012-07-01

    The management of a tooth with incomplete root maturation and a necrotic pulp is an endodontic and a restorative challenge. Apexification procedures alone leave the tooth in a weakened state and at risk for reinfection. Regenerative endodontic procedures potentially offer advantages, including the possibility of hard tissue deposition and continued root development. Case studies have reported regeneration of human pulplike tissues in vivo, but there is no protocol that reliably regenerates pulplike tissue. This article summarizes historical, current, and future regenerative treatment approaches. Copyright © 2012 Elsevier Inc. All rights reserved.

  20. [Vitreoretinal outpatient surgery: clinical and financial considerations].

    Science.gov (United States)

    Creuzot-Garcher, C; Aubé, H; Candé, F; Dupont, G; Guillaubey, A; Malvitte, L; Arnavielle, S; Bron, A

    2008-11-01

    Vitreoretinal surgery has benefited from great advances opening the opportunity for outpatient management. We report on the 6-month experience of outpatient surgery for vitreoretinal diseases. From November 2007 to April 2008, 270 patients benefited from a vitreoretinal surgery, with 173 retinal detachments, 63 epiretinal membranes, and 34 other procedures. Only 8.5% (n=23) of the patients had to stay at the hospital one or two nights. The main reasons were the distance from the hospital and surgery on a single-eye patient. The questionnaire given after the surgery showed that almost all the patients were satisfied with the outpatient setting. In contrast, the financial results showed a loss of income of around 400,000 euros due to the low level of payment of outpatient surgery in France by the national health insurance system. Vitreoretinal surgery can be achieved in outpatient surgery with an improvement in the information given to the patients and the overall organization of the hospitalization. However, the current income provided with vitreoretinal outpatient surgery is highly disadvantageous in France, preventing this method from being generalized.

  1. Safety considerations in the clinical setting

    International Nuclear Information System (INIS)

    de Jong, R.

    1985-01-01

    Safe, everyday use of /sup 195m/Hg→/sup 195m/Au generators requires strict adherence to a handling protocol to ensure a minimal radiation risk to the patient. This protocol involves preparatory washings of the generator, as well as frequent washings between patient administrations. The design of the generator makes massive breakthrough of parent isotope extremely improbable. Because the possibility of quality control on individual administered doses is not feasible, a check on parent-isotope leakage must be performed very regularly

  2. Oil and gas exploration and production activities in Brazil: The consideration of environmental issues in the bidding rounds promoted by the National Petroleum Agency

    International Nuclear Information System (INIS)

    Mariano, Jacqueline; La Rovere, Emilio

    2007-01-01

    This paper aims to address and analyze the environmental issues related to the Brazilian bidding rounds for exploration and production of oil and natural gas held by the National Petroleum Agency (ANP) from 1999 to 2005. To do so, after a brief retrospective of the seven rounds, the four main points of the bidding process are analyzed from an environmental perspective: the selection criteria for choosing the areas to be offered, the Minimum Exploration Program required by ANP, the eligibility criteria for the oil companies to take part of the bids and the concession agreements. Thus, it is possible to present the evolution of the environmental component insertion from the first to the seventh bidding round, and then to assess its efficiency in each round, apart from offering suggestions for its improvement. The suggestions presented are based on the related international experience and on the lessons learned during the last seven years

  3. 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

  4. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  6. Sustainable clinical research, health economic aspects and medical marketing: drivers of product innovation.

    Science.gov (United States)

    Haschke, Ferdinand; Klassen-Wigger, Petra

    2010-01-01

    Marketing-driven innovation in the field of pediatric nutrition, in particular in the infant formula segment is not sustainable. New benefits of products must be scientifically proven and safety and efficacy of new formulae established in clinical trials. The scientific innovation process of three infant formulae is described. Improvement in protein quality allowed to reduce the protein concentration in whey-based infant formula. Weight gain and BMI of infants fed those formulae corresponds to breastfed infants and is lower than in infants fed traditional formulae with higher protein concentration. A meta-analysis indicates associations between rapid weight gain in infancy and obesity later in life. If infants cannot be exclusively breastfed until 4-6 months of age, feeding low-protein formulae may contribute to positive long-term health outcome with potentially important health economic effects. A partially hydrolyzed whey based formula for prevention of allergic symptoms in children with hereditary risk for allergic diseases was developed more than 25 years ago. The most recent meta-analysis which included 15 randomized clinical trials indicates that the risk of all allergic diseases and atopic dermatitis/eczema is significantly reduced in infants at risk when the partially hydrolyzed formula is fed. The partially hydrolyzed formula had the same protective effect as casein-based high-degree extensively hydrolyzed formula. Because of substantial price differences between the two formulae, feeding the partially hydrolyzed whey formula is cost saving. Hypoallergenic claims can be made in many countries, and international nutrition committees have positively commented the preventive effect of those formulae. Acidified formulae have been widely used during the last decade in replacement feeding programs for infants whose mothers are HIV positive. The formula was innovated by improving whey protein quality and lowering protein concentration. The bacteriostatic

  7. Optimization and scale up of microfluidic nanolipomer production method for preclinical and potential clinical trials.

    Science.gov (United States)

    Gdowski, Andrew; Johnson, Kaitlyn; Shah, Sunil; Gryczynski, Ignacy; Vishwanatha, Jamboor; Ranjan, Amalendu

    2018-02-12

    The process of optimization and fabrication of nanoparticle synthesis for preclinical studies can be challenging and time consuming. Traditional small scale laboratory synthesis techniques suffer from batch to batch variability. Additionally, the parameters used in the original formulation must be re-optimized due to differences in fabrication techniques for clinical production. Several low flow microfluidic synthesis processes have been reported in recent years for developing nanoparticles that are a hybrid between polymeric nanoparticles and liposomes. However, use of high flow microfluidic synthetic techniques has not been described for this type of nanoparticle system, which we will term as nanolipomer. In this manuscript, we describe the successful optimization and functional assessment of nanolipomers fabricated using a microfluidic synthesis method under high flow parameters. The optimal total flow rate for synthesis of these nanolipomers was found to be 12 ml/min and flow rate ratio 1:1 (organic phase: aqueous phase). The PLGA polymer concentration of 10 mg/ml and a DSPE-PEG lipid concentration of 10% w/v provided optimal size, PDI and stability. Drug loading and encapsulation of a representative hydrophobic small molecule drug, curcumin, was optimized and found that high encapsulation efficiency of 58.8% and drug loading of 4.4% was achieved at 7.5% w/w initial concentration of curcumin/PLGA polymer. The final size and polydispersity index of the optimized nanolipomer was 102.11 nm and 0.126, respectively. Functional assessment of uptake of the nanolipomers in C4-2B prostate cancer cells showed uptake at 1 h and increased uptake at 24 h. The nanolipomer was more effective in the cell viability assay compared to free drug. Finally, assessment of in vivo retention in mice of these nanolipomers revealed retention for up to 2 h and were completely cleared at 24 h. In this study, we have demonstrated that a nanolipomer formulation can be successfully

  8. A quasi-Delphi study on technological barriers to the uptake of hydrogen as a fuel for transport applications-Production, storage and fuel cell drivetrain considerations

    Science.gov (United States)

    Hart, David; Anghel, Alexandra T.; Huijsmans, Joep; Vuille, François

    The introduction of hydrogen in transport, particularly using fuel cell vehicles, faces a number of technical and non-technical hurdles. However, their relative importance is unclear, as are the levels of concern accorded them within the expert community conducting research and development within this area. To understand what issues are considered by experts working in the field to have significant potential to slow down or prevent the introduction of hydrogen technology in transport, a study was undertaken, primarily during 2007. Three key technology areas within hydrogen transport were selected - hydrogen storage, fuel cell drivetrains, and small-scale hydrogen production - and interviews with selected experts conducted. Forty-nine experts from 34 organisations within the fuel cell, automotive, industrial gas and other related industries participated, in addition to some key academic and government figures. The survey was conducted in China, Japan, North America and Europe, and analysed using conventional mathematical techniques to provide weighted and averaged rankings of issues viewed as important by the experts. It became clear both from the interviews and the subsequent analysis that while a primary concern in China was fundamental technical performance, in the other regions cost and policy were rated more highly. Although a few individual experts identified possible technical showstoppers, the overall message was that pre-commercial hydrogen fuel cell vehicles could realistically be on the road in tens of thousands within 5 years, and that full commercialisation could take place within 10-15 years, without the need for radical technical breakthroughs. Perhaps surprisingly, the performance of hydrogen storage technologies was not viewed as a showstopper, though cost was seen as a significant challenge. Overall, however, coherent policy development was more frequently identified as a major issue to address.

  9. 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...

  10. 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…

  11. Association of biofilm production with colonization among clinical isolates of Acinetobacter baumannii.

    Science.gov (United States)

    Ryu, Seong Yeol; Baek, Won-Ki; Kim, Hyun Ah

    2017-03-01

    The pathogen Acinetobacter baumannii is increasingly causing healthcare-associated infections worldwide, particularly in intensive care units. Biofilm formation, a factor contributing to the virulence of A. baumannii , is associated with long-term persistence in hospital environments. The present study investigates the clinical impact of biofilm production on colonization and acquisition after patient admission. Forty-nine A. baumannii isolates were obtained between August and November 2013 from Keimyung University Dongsan Medical Center, Daegu, Korea. All isolates were obtained from sputum samples of new patients infected or colonized by A. baumannii . The microtiter plate assay was used to determine biofilm formation. Twenty-four A. baumannii isolates (48%) demonstrated enhanced biofilm formation capacity than that of the standard A. baumannii strain (ATCC 19606). All isolates were resistant to carbapenem, 38 isolates (77%) were collected from patients in an intensive care unit, and 47 isolates (95%) were from patients who had been exposed to antibiotics in the previous month. The median duration of colonization was longer for biofilm-producing isolates than that of the biofilm non-biofilm producing isolates (18 days vs. 12 days, p < 0.05). Simultaneous colonization with other bacteria was more common for biofilm-producing isolates than that for the non-biofilm producing isolates. The most prevalent co-colonizing bacteria was Staphylococcus aureus . Biofilm-producing isolates seem to colonize the respiratory tract for longer durations than the non-biofilm producing isolates. During colonization, biofilm producers promote co-colonization by other bacteria, particularly S. aureus . Additional research is required to determine possible links between biofilm formation and nosocomial infection.

  12. Clinical evaluation of immune-promoting functions of the developed product (HemoHIM)

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Kyoung Soo; Lee, Ill Kyoo; Kwon, Soon Gil [The Catholic University of Korea, Seoul (Korea, Republic of)

    2007-07-15

    We performed a clinical study to evaluate the immune promotion and antioxidant effects of the developed product (HemoHIM) in healthy or subhealthy people. Volunteers with white blood cell numbers between 5000 and 10000/ul were recruited and the subjects were selected by appropriate inclusion and exclusion rules. The subjects were randomly assigned to 3 groups (HemoHIM 6g/day, HemoHIM 12g/day, Placebo). HemoHIM or placebo were adminstered for 2 months and the blood were collected and analyzed at 1 month and 2 month after the intake. The collected blood was analyzed for blood cell number, serum biochemical values (liver and kidney function), immunological activity of blood cells, antioxidant activity of blood plasma, and stress hormone level in the saliva. Finally the data of 88 subjects were analyzed for the immune promoting and antioxidant effects of HemoHIM. In results, no significant changes in blood cell numbers (white blood cell, lymphocyte, red blood cell) were observed in HemoHIM intake groups. However, NK cell activity were increased in HemoHIM intake groups and also IFN-gamma and IL-12, the biomarkers of immune cell functions, were increased in proportion to the dose and intake periode of HemoHIM. The antioxidant biomarker (TAS) was not significantly changed by HemoHIM intake. Besides, the serum biochemical analysis for liver and kidney functions, and the general medical examination showed the HemoHIM showed no side-effects, thus reconfirming its safety in humans. In conclusion, this study showed HemoHIM has a significant effects on the promotion of immune functions, while it has neither side-effects nor toxicity in humans. The results of this study may be utilized for the scientific data to acquire the Health Functional Food Certification of HemoHIM from Korea FDA

  13. The Clinical and Occupational Correlates of Work Productivity Loss Among Employed Patients With Depression

    Science.gov (United States)

    Lerner, Debra; Adler, David A.; Chang, Hong; Berndt, Ernst R.; Irish, Julie T.; Lapitsky, Leueen; Hood, Maggie Y.; Reed, John; Rogers, William H.

    2014-01-01

    Employers who are developing strategies to reduce health-related productivity loss may benefit from aiming their interventions at the employees who need them most. We determined whether depression’s negative productivity impact varied with the type of work employees performed. Subjects (246 with depression and 143 controls) answered the Work Limitations Questionnaire and additional work questions. Occupational requirements were measured objectively. In multiple regression analyses, productivity was most influenced by depression severity (P increased employee vulnerability to productivity loss. Losses increased when employees had occupations requiring proficiency in decision-making and communication and/or frequent customer contact (P productivity loss by identifying health and productivity improvement priorities. PMID:15194895

  14. 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

  15. Market trends in baby skin care products and implications for clinical practice.

    Science.gov (United States)

    Gao, Xiang; Simpson, Eric L

    2014-01-01

    Although the U.S. pediatric skin care market is a $1.7 billion industry, little is known regarding the usage pattern of skin care products in very young children. We have begun to recognize that common over-the-counter skin care products may have positive or negative effects on skin barrier function. Thus, knowing what and how skin care products are used early in life is important. The goal of the current study was to better understand skin care product use in the United States using market research data. We found that the prevalence of use was greater than 50% for all skin care product categories and age groups. Premoistened cleansing wipes and cloths were the most frequently used product, followed by baby oil and lotion and body and baby powder. Baby bath and shampoo products were used at least five times per week per household, and caregivers generally preferred products that were fragrance-free and made for sensitive skin. Lower-income households reported a higher frequency of product use and were less likely to purchase fragrance-free products or ones that were made for sensitive skin. Our findings suggest that the prevalence of pediatric skin care product use is high and conflicts with current recommended skin care guidelines. Product use and preferences may also vary according to race and ethnicity and household income level. © 2014 Wiley Periodicals, Inc.

  16. 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.)

  17. Clinical trial registries: a practical guide for sponsors and researchers of medicinal products

    National Research Council Canada - National Science Library

    Foote, MaryAnn

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix MaryAnn Foote Clinical trial registries and publication of results - a primer . . . . . . . . . . . . . . . . . . 1 Ana Marušić and Charlotte Haug The journal...

  18. 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.

  19. From Idea to Product--Translating Knowledge between the Lab and the Clinic

    Science.gov (United States)

    Ali, Ayfer Habib

    2012-01-01

    This dissertation is composed of three essays looking at innovation at Academic Medical Centers. It tries to empirically explore the problem of translating knowledge from the laboratory bench to the clinic and from the clinic to the bench. Chapter 1, co-authored with Iain Cockburn, establishes the importance of in-house complementary knowledge in…

  20. Biological Variance in Agricultural Products. Theoretical Considerations

    NARCIS (Netherlands)

    Tijskens, L.M.M.; Konopacki, P.

    2003-01-01

    The food that we eat is uniform neither in shape or appearance nor in internal composition or content. Since technology became increasingly important, the presence of biological variance in our food became more and more of a nuisance. Techniques and procedures (statistical, technical) were

  1. 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

  2. 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.

  3. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

    DEFF Research Database (Denmark)

    Schulman, S; Angerås, U; Bergqvist, D

    2010-01-01

    in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials...... of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols....

  4. Early Improvement in Work Productivity Predicts Future Clinical Course in Depressed Outpatients: Findings from the CO-MED Trial

    Science.gov (United States)

    Jha, Manish K.; Minhajuddin, Abu; Greer, Tracy L.; Carmody, Thomas; Rush, A. John; Trivedi, Madhukar H.

    2018-01-01

    Objective Depression symptom severity, the most commonly studied outcome in antidepressant treatment trials, accounts for only a small portion of burden related to major depression. While lost work productivity is the biggest contributor to depression’s economic burden, few studies have systematically evaluated the independent effect of treatment on work productivity and the relationship between changes in work productivity and longer-term clinical course. Method Work productivity was measured repeatedly by the Work Productivity and Activity Impairment (WPAI) self-report in 331 employed participants with major depression enrolled in the Combining Medications to Enhance Depression Outcomes (CO-MED) trial. Trajectories of change in work productivity during the first 6 weeks of treatment were identified and used to predict remission at 3 and 7 months. Results Participants reported reduced absence from work and increased work productivity with antidepressant treatment even after controlling for changes in depression severity. Three distinct trajectories of changes in work productivity were identified: 1) robust early improvement (24%), 2) minimal change (49%), and 3) high-impairment slight reduction (27%). As compared to other participants, those with robust improvement had 3–5 times higher remission rates at 3 months and 2–5 times higher remission rates at 7 months, even after controlling for select baseline variables and remission status at week 6. Conclusions In this secondary analysis, self-reported work productivity improved in depressed patients with antidepressant treatment even after accounting for depressive symptom reduction. Early improvement in work productivity is associated with much higher remission rates after 3 and 7 months of treatment. PMID:27523501

  5. Work productivity in rheumatoid arthritis: relationship with clinical and radiological features.

    Science.gov (United States)

    Chaparro Del Moral, Rafael; Rillo, Oscar Luis; Casalla, Luciana; Morón, Carolina Bru; Citera, Gustavo; Cocco, José A Maldonado; Correa, María de Los Ángeles; Buschiazzo, Emilio; Tamborenea, Natalia; Mysler, Eduardo; Tate, Guillermo; Baños, Andrea; Herscovich, Natalia

    2012-01-01

    Objective. To assess the relationship between work productivity with disease activity, functional capacity, life quality and radiological damage in patients with rheumatoid arthritis (RA). Methods. The study included consecutive employed patients with RA (ACR'87), aged over 18. Demographic, disease-related, and work-related variables were determined. The reduction of work productivity was assessed by WPAI-RA. Results. 90 patients were evaluated, 71% women. Age average is 50 years old, DAS28 4, and RAQoL 12. Median SENS is 18 and HAQ-A 0.87. Mean absenteeism was of 14%, presenting an average of 6.30 work hours wasted weekly. The reduction in performance at work or assistance was of 38.4% and the waste of productivity was of 45%. Assistance correlated with DAS28 (r = 0.446; P productivity was noticed in higher levels of activity and functional disability. Patients with SENS > 18 showed lower work productivity than those with SENS work productivity were HAQ-A and RAQoL. Conclusion. RA patients with higher disease severity showed higher work productivity compromise.

  6. The establishment of a bank of stored clinical bone marrow stromal cell products

    Directory of Open Access Journals (Sweden)

    Sabatino Marianna

    2012-02-01

    Full Text Available Abstract Background Bone marrow stromal cells (BMSCs are being used to treat a variety of conditions. For many applications a supply of cryopreserved products that can be used for acute therapy is needed. The establishment of a bank of BMSC products from healthy third party donors is described. Methods The recruitment of healthy subjects willing to donate marrow for BMSC production and the Good Manufacturing Practices (GMP used for assessing potential donors, collecting marrow, culturing BMSCs and BMSC cryopreservation are described. Results Seventeen subjects were enrolled in our marrow collection protocol for BMSC production. Six of the 17 subjects were found to be ineligible during the donor screening process and one became ill and their donation was cancelled. Approximately 12 ml of marrow was aspirated from one posterior iliac crest of 10 donors; one donor donated twice. The BMSCs were initially cultured in T-75 flasks and then expanded for three passages in multilayer cell factories. The final BMSC product was packaged into units of 100 × 106 viable cells, cryopreserved and stored in a vapor phase liquid nitrogen tank under continuous monitoring. BMSC products meeting all lot release criteria were obtained from 8 of the 11 marrow collections. The rate of growth of the primary cultures was similar for all products except those generated from the two oldest donors. One lot did not meet the criteria for final release; its CD34 antigen expression was greater than the cut off set at 5%. The mean number of BMSC units obtained from each donor was 17 and ranged from 3 to 40. Conclusions The production of large numbers of BMSCs from bone marrow aspirates of healthy donors is feasible, but is limited by the high number of donors that did not meet eligibility criteria and products that did not meet lot release criteria.

  7. 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 an