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Sample records for good clinical responses

  1. Dangerous goods emergency response

    International Nuclear Information System (INIS)

    Price, K.

    1991-01-01

    This paper reports on a general overview of the State of Western Australia including: the legal framework of the Dangerous Goods and Emergency response management scenarios (which consist mainly of fuel products such as LP gas); particular problems unique to the Western Australian environment; what has been done to overcome those problems. Western Australia has an area of about two and a half million square kilometers. The demography of the State is such that the population is concentrated in the south-west corner of the State with isolated pockets, mainly associated with mineral development but also associated with agriculture, scattered throughout the State

  2. [Good clinical practices in clinical trials: the responsibility of the researcher. A survey of 827 hospital physicians (I). Availability. Monitoring. Safety. Contract].

    Science.gov (United States)

    Dal-Ré, R

    1993-03-06

    The Law of Medicaments establishes that clinical trials (CT) with drugs must be carried out following the of Good Clinical Practice guidelines (GCP). The attitude of hospital physicians to the GCP prior to its implementation as mandatory in accordance with Spanish legislation was considered to be of interest. An anonymous survey was used with closed response questions. Questions referring to the responsibilities of the investigator included in the GCP were included. From December 1988 to February 1990 the survey was distributed among 1,706 hospital medical staff members, of any specialty, who had or had not participated in CT. In this article the results of the questions regarding the availability of the investigative team, CT monitorization, management of adverse reactions, the safety of the participants in the CT and the contract between the sponsor and the researcher are presented. A total of 827 hospital doctors replied to the survey. Fifty-nine percent had intervened in CT with drugs. At least 94% of those surveyed considered that the researcher must have the time and number of eligible patients which the CT requires. There was high acceptance (> or = 78%) of the clinical audits to be performed by the health authorities and the sponsor company of the CT. The need of urgent communication of the severe adverse reactions is admitted by a great majority (> or = 95%) of those surveyed. Eighty-five percent believe that patients should be insured against damage derived from CT with 76% considering that the investigator should sign a contract with the sponsor; 68% and 59% would hand in a copy of the same to the CT committee and the remainder of the research team, respectively. According to the Good Clinical Practice dealt with in this article, the responsibilities of the investigator have been widely accepted by the hospital physicians surveyed, therefore no problems should be expected upon the implementation of the same in this country. However, the economic

  3. The clinic as a good corporate neighbor.

    Science.gov (United States)

    Sass, Hans-Martin

    2013-02-01

    Clinics today specialize in health repair services similar to car repair shops; procedures and prices are standardized, regulated, and inflexibly uniform. Clinics of the future have to become Health Care Centers in order to be more respected and more effective corporate neighbors in offering outreach services in health education and preventive health care. The traditional concept of care for health is much broader than repair management and includes the promotion of lay health competence and responsibility in healthy social and natural environments. The corporate profile and ethics of the clinic as a good and competitive local neighbor will have to focus on [a] better personalized care, [b] education and services in preventive care, [c] direct or web-based information and advice for general, seasonal, or age related health risks, and on developing and improving trustworthy character traits of the clinic as a corporate person and a good neighbor.

  4. Is drug-induced toxicity a good predictor of response to neo-adjuvant chemotherapy in patients with breast cancer? -A prospective clinical study

    International Nuclear Information System (INIS)

    Chintamani; Singhal, Vinay; Singh, JP; Lyall, Ashima; Saxena, Sunita; Bansal, Anju

    2004-01-01

    Neo-adjuvant chemotherapy is an integral part of multi-modality approach in the management of locally advanced breast cancer and it is vital to predict the response in order to tailor the regime for a patient. The common final pathway in the tumor cell death is believed to be apoptosis or programmed cell death and chemotherapeutic drugs like other DNA-damaging agents act on rapidly multiplying cells including both the tumor and the normal cells by following the same common final pathway. This could account for both the toxic effects and the response. Absence or decreased apoptosis has been found to be associated with chemo resistance. The change in expression of apoptotic markers (Bcl-2 and Bax proteins) brought about by various chemotherapeutic regimens is being used to identify drug resistance in the tumor cells. A prospective clinical study was conducted to assess whether chemotherapy induced toxic effects could serve as reliable predictors of apoptosis or response to neo-adjuvant chemotherapy in patients with locally advanced breast cancer. 50 cases of locally advanced breast cancer after complete routine and metastatic work up were subjected to trucut biopsy and the tissue evaluated immunohistochemically for apoptotic markers (bcl-2/bax ratio). Three cycles of Neoadjuvant Chemotherapy using FAC regime (5-fluorouracil, adriamycin, cyclophosphamide) were given at three weekly intervals and patients assessed for clinical response as well as toxicity after each cycle. Modified radical mastectomy was performed in all patients three weeks after the last cycle and the specimen were re-evaluated for any change in the bcl-2/bax ratio. The clinical response, immunohistochemical response and the drug-induced toxicity were correlated and compared. Descriptive studies were performed with SPSS version 10 and the significance of response was assessed using paired t-test. Significance of correlation between various variables was assessed using chi-square test and coefficient

  5. Is drug-induced toxicity a good predictor of response to neo-adjuvant chemotherapy in patients with breast cancer? -A prospective clinical study

    Directory of Open Access Journals (Sweden)

    Singh JP

    2004-08-01

    Full Text Available Abstract Background Neo-adjuvant chemotherapy is an integral part of multi-modality approach in the management of locally advanced breast cancer and it is vital to predict the response in order to tailor the regime for a patient. The common final pathway in the tumor cell death is believed to be apoptosis or programmed cell death and chemotherapeutic drugs like other DNA-damaging agents act on rapidly multiplying cells including both the tumor and the normal cells by following the same common final pathway. This could account for both the toxic effects and the response. Absence or decreased apoptosis has been found to be associated with chemo resistance. The change in expression of apoptotic markers (Bcl-2 and Bax proteins brought about by various chemotherapeutic regimens is being used to identify drug resistance in the tumor cells. A prospective clinical study was conducted to assess whether chemotherapy induced toxic effects could serve as reliable predictors of apoptosis or response to neo-adjuvant chemotherapy in patients with locally advanced breast cancer. Methods 50 cases of locally advanced breast cancer after complete routine and metastatic work up were subjected to trucut biopsy and the tissue evaluated immunohistochemically for apoptotic markers (bcl-2/bax ratio. Three cycles of Neoadjuvant Chemotherapy using FAC regime (5-fluorouracil, adriamycin, cyclophosphamide were given at three weekly intervals and patients assessed for clinical response as well as toxicity after each cycle. Modified radical mastectomy was performed in all patients three weeks after the last cycle and the specimen were re-evaluated for any change in the bcl-2/bax ratio. The clinical response, immunohistochemical response and the drug-induced toxicity were correlated and compared. Descriptive studies were performed with SPSS version 10 and the significance of response was assessed using paired t-test. Significance of correlation between various variables was

  6. Favorable response to doxorubicin combination chemotherapy does not yield good clinical outcome in patients with metastatic breast cancer with triple-negative phenotype

    International Nuclear Information System (INIS)

    Yi, Seong Yoon; Cho, Eun Yoon; La Choi, Yoon; Park, Yeon Hee; Im, Young-Hyuck; Ahn, Jin Seok; Uhm, Ji Eun; Lim, Do Hyoung; Ji, Sang Hoon; Jun, Hyun Jung; Kim, Kyoung Ha; Chang, Myung Hee; Park, Min Jae

    2010-01-01

    We analyzed the responses to first line treatment and clinical outcomes of metastatic breast cancer patients treated with palliative doxorubicin/cyclophosphamide (AC) according to molecular cancer subtype. A retrospective analysis was performed for 110 metastatic breast cancer patients selected on the basis of palliative AC treatment and the availability of immunohistochemical data for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER-2/neu) status. Of the 110 patients analyzed, 71 (64.5%) were hormone receptor positive (HR+), 14 (12.7%) were HER2+, and 25 (22.7%) were triple negative (TN). There were no differences in age, stage at diagnosis, total number of cycles of palliative chemotherapy, incidence of visceral metastasis, and metastatic sites with the exception of liver among breast cancer subtypes. The overall response rates to AC were 55.9% for the HR+ subgroup, 42.9% for the HER2+ subgroup, and 56.5% for the TN subgroup. The progression-free survival (PFS) in patients with HER2+ and TN were significantly shorter than in the HR+ (median PFS, 9.1 vs 8.1 vs 11.5 months, respectively; p = 0.0002). The overall survival (OS) was 25.4 months in the TN subgroup and 27.3 months in HER2+ subgroup. The median OS for these two groups was significantly shorter than for patients in the HR+ subgroup (median, 38.5 months; 95% CI, 30.1-46.9 months; p < 0.0001). The response to palliative AC chemotherapy did not differ among breast cancer subtypes. Despite chemosensitivity for palliative AC, the TN subtype has a shorter overall survival than non-TN subtypes. Innovative treatment strategies should be developed to slow the course of disease

  7. Favorable response to doxorubicin combination chemotherapy does not yield good clinical outcome in patients with metastatic breast cancer with triple-negative phenotype

    Directory of Open Access Journals (Sweden)

    La Choi Yoon

    2010-10-01

    Full Text Available Abstract Background We analyzed the responses to first line treatment and clinical outcomes of metastatic breast cancer patients treated with palliative doxorubicin/cyclophosphamide (AC according to molecular cancer subtype. Methods A retrospective analysis was performed for 110 metastatic breast cancer patients selected on the basis of palliative AC treatment and the availability of immunohistochemical data for estrogen receptor (ER, progesterone receptor (PR, and human epidermal growth factor receptor-2 (HER-2/neu status. Results Of the 110 patients analyzed, 71 (64.5% were hormone receptor positive (HR+, 14 (12.7% were HER2+, and 25 (22.7% were triple negative (TN. There were no differences in age, stage at diagnosis, total number of cycles of palliative chemotherapy, incidence of visceral metastasis, and metastatic sites with the exception of liver among breast cancer subtypes. The overall response rates to AC were 55.9% for the HR+ subgroup, 42.9% for the HER2+ subgroup, and 56.5% for the TN subgroup. The progression-free survival (PFS in patients with HER2+ and TN were significantly shorter than in the HR+ (median PFS, 9.1 vs 8.1 vs 11.5 months, respectively; p = 0.0002. The overall survival (OS was 25.4 months in the TN subgroup and 27.3 months in HER2+ subgroup. The median OS for these two groups was significantly shorter than for patients in the HR+ subgroup (median, 38.5 months; 95% CI, 30.1-46.9 months; p Conclusions The response to palliative AC chemotherapy did not differ among breast cancer subtypes. Despite chemosensitivity for palliative AC, the TN subtype has a shorter overall survival than non-TN subtypes. Innovative treatment strategies should be developed to slow the course of disease.

  8. How do we know if a clinical practice guideline is good? A response to Djulbegovic and colleagues' use of fast-and-frugal decision trees to improve clinical care strategies.

    Science.gov (United States)

    Mercuri, Mathew

    2018-04-17

    Clinical practice guidelines (CPGs) and clinical pathways have become important tools for improving the uptake of evidence-based care. Where CPGs are good, adherence to the recommendations within is thought to result in improved patient outcomes. However, the usefulness of such tools for improving patient important outcomes depends both on adherence to the guideline and whether or not the CPG in question is good. This begs the question of what it is that makes a CPG good? In this issue of the Journal, Djulbegovic and colleagues offer a theory to help guide the development of CPGs. The "fast-and-frugal tree" (FFT) heuristic theory is purported to provide the theoretical structure needed to quantitatively assess clinical guidelines in practice, something that the lack of theory to guide CPG development has precluded. In this paper, I examine the role of FFTs in providing an adequate theoretical framework for developing CPGs. In my view, positioning guideline development within the FFT framework may help with problems related to adherence. However, I believe that FTTs fall short in providing panel members with the theoretical basis needed to justify which factors should be considered when developing a CPG, how information on those factors derived from research studies should be interpreted, and how those factors should be integrated into the recommendation. © 2018 John Wiley & Sons, Ltd.

  9. Responsible Marketing: Doing Well by Doing Good

    Directory of Open Access Journals (Sweden)

    Bhattacharya CB

    2016-05-01

    Full Text Available Business value and social or environmental values can go hand in hand. If companies not only create socio-environmental value by caring for people and our planet, but also drive business value and profit through such initiatives, then CSR or corporate social responsibility can be a source of competitive differentiation and advantage. In such companies, sustainability initiatives are close to the core businesses which leverage the competencies of the company and in line with company values and principles. While some stumbling blacks need to be mastered on the way, many companies have applied this concept successfully. The business value created by CSR initiatives ranges from employee and customer loyalty, positive word of mouth, resilience to negative information about the company and several other coveted business outcomes. To integrate CSR successfully, management should be committed to its causes, integrate all stakeholders in the initiatives and communicate about projects in an open, honest and authentic way. Much like other aspects of marketing strategy, there is a need to monitor and measure sustainability efforts to tune activities and insure overall success.

  10. [What everybody should know about good clinical practices].

    Science.gov (United States)

    Osorio, Lyda

    2015-01-01

    An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.

  11. Clinical audit: Development of the criteria of good practices

    International Nuclear Information System (INIS)

    Soimakallio, S.; Alanen, A.; Jaervinen, H.; Ahonen, A.; Ceder, K.; Lyyra-Laitinen, T.; Paunio, M.; Sinervo, T.; Wigren, T.

    2011-01-01

    Clinical audit is a systematic review of the procedures in order to improve the quality and the outcome of patient care, whereby the procedures are examined against agreed standards for good medical Radiological procedures. The criteria of good procedures (i.e. the good practice) are thus the cornerstones for development of clinical audits: these should be the basis of assessments regardless of the type of the audit-external, internal, comprehensive or partial. A lot of criteria for good practices are available through the recommendations and publications by international and national professional societies and other relevant organisations. For practical use in clinical audits, the criteria need to be compiled, sorted out and agreed on for the particular aims of an audit (comprehensive or partial, external or internal). The national professional and scientific societies can provide valuable contribution to this development. For examination-or treatment-specific criteria- preliminary consensus needs to be obtained with the help of clinical experts, while clinical audits can be useful as a benchmarking tool to improve the criteria. (authors)

  12. Rules for the certification of good practices in clinical laboratories. No regulation. 3-2009. Good Laboratory Practice

    International Nuclear Information System (INIS)

    2015-01-01

    Regulation for Certification of Good Practices in clinical laboratories, hereinafter Regulation establishes the methodology and procedures for clinical laboratories to demonstrate their state of compliance with good practices, according to Regulation 3-2009, and that the CECMED can verify.

  13. 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

  14. What makes a good clinical student and teacher? An exploratory study.

    Science.gov (United States)

    Goldie, John; Dowie, Al; Goldie, Anne; Cotton, Phil; Morrison, Jill

    2015-03-10

    What makes a good clinical student is an area that has received little coverage in the literature and much of the available literature is based on essays and surveys. It is particularly relevant as recent curricular innovations have resulted in greater student autonomy. We also wished to look in depth at what makes a good clinical teacher. A qualitative approach using individual interviews with educational supervisors and focus groups with senior clinical students was used. Data was analysed using a "framework" technique. Good clinical students were viewed as enthusiastic and motivated. They were considered to be proactive and were noted to be visible in the wards. They are confident, knowledgeable, able to prioritise information, flexible and competent in basic clinical skills by the time of graduation. They are fluent in medical terminology while retaining the ability to communicate effectively and are genuine when interacting with patients. They do not let exam pressure interfere with their performance during their attachments. Good clinical teachers are effective role models. The importance of teachers' non-cognitive characteristics such as inter-personal skills and relationship building was particularly emphasised. To be effective, teachers need to take into account individual differences among students, and the communicative nature of the learning process through which students learn and develop. Good teachers were noted to promote student participation in ward communities of practice. Other members of clinical communities of practice can be effective teachers, mentors and role models. Good clinical students are proactive in their learning; an important quality where students are expected to be active in managing their own learning. Good clinical students share similar characteristics with good clinical teachers. A teacher's enthusiasm and non-cognitive abilities are as important as their cognitive abilities. Student learning in clinical settings is a

  15. Good for God? Religious motivation reduces perceived responsibility for and morality of good deeds.

    Science.gov (United States)

    Gervais, Will M

    2014-08-01

    Many people view religion as a crucial source of morality. However, 6 experiments (total N = 1,078) revealed that good deeds are perceived as less moral if they are performed for religious reasons. Religiously motivated acts were seen as less moral than the exact same acts performed for other reasons (Experiments 1-2 and 6). Religious motivations also reduced attributions of intention and responsibility (Experiments 3-6), an effect that fully mediated the effect of religious motivations on perceived morality (Experiment 6). The effects were not explained by different perceptions of motivation orientation (i.e., intrinsic vs. extrinsic) across conditions (Experiment 4) and also were evident when religious upbringing led to an intuitive moral response (Experiment 5). Effects generalized across religious and nonreligious participants. When viewing a religiously motivated good deed, people infer that actually helping others is, in part, a side effect of other motivations rather than an end in itself. Thus, religiously motivated actors are seen as less responsible than secular actors for their good deeds, and their helping behavior is viewed as less moral than identical good deeds performed for either unclear or secular motivations. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  16. 18 CFR 2.20 - Good faith requests for transmission services and good faith responses by transmitting utilities.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Good faith requests for transmission services and good faith responses by transmitting utilities. 2.20 Section 2.20 Conservation of... Power Act § 2.20 Good faith requests for transmission services and good faith responses by transmitting...

  17. Goodness-of-Fit Assessment of Item Response Theory Models

    Science.gov (United States)

    Maydeu-Olivares, Alberto

    2013-01-01

    The article provides an overview of goodness-of-fit assessment methods for item response theory (IRT) models. It is now possible to obtain accurate "p"-values of the overall fit of the model if bivariate information statistics are used. Several alternative approaches are described. As the validity of inferences drawn on the fitted model…

  18. [Identifying indicators of good practice in clinical and healthcare management].

    Science.gov (United States)

    Bermúdez Tamayo, C; Olry de Labry Lima, A; García Mochón, L

    2018-03-06

    To identify good practices in order to develop and implement indicators of health outcomes for clinical and healthcare management, as well as the characteristics for an indicator to be considered adequate. A scoping review was performed, with the following phases: 1) Search and identification of bibliography. 2) Selection of relevant documents. Including those studies that discussed issues related to good practices for the use of health indicators in the management field. Those published in a language other than English or Spanish or before 2006 were excluded. 3) Analysis and extraction of information. 4) Consultation with stakeholders, using a qualitative methodology through Concept Mapping, with the participation of 40 experts (decision-makers, scientific societies, and health professionals). The data collection process included an inductive and structured procedure, with prioritisation of ideas grouped into clusters, according to feasibility and importance criteria (0-10 scale). Good practices identified 2 levels: 1) macro-management: Define a framework for the evaluation of indicators and establish a benchmark of indicators. 2) meso-management: Establish indicators according to evidence and expert consensus, taking into account priority areas and topics, testing before final use, and communicate results adequately. The characteristics of a suitable indicator are: 1) Approach of an important issue, 2) Scientific validity, 3) Possibility of measurement with reliable data, 4) Meaning of useful and applicable measurement, and 5) Wide scope. The best practices for the use of indicators in clinical and healthcare management can make it easier to monitor performance and accountability, as well as to support the decision-making addressed at the development of initiatives for quality improvement. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  19. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Science.gov (United States)

    2012-08-16

    ... investigator initiated research. Topics for discussion include the following: (1) What FDA Expects in a...] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The...

  20. Corporate Social Responsibility Benchmarking in the Sporting Goods Industry

    OpenAIRE

    Åkesson, Taru

    2010-01-01

    The objective of this thesis was to benchmark the current status of Corporate Social Responsibility in the sporting goods industry for Amer Sports. The author was given a variety of questions and themes, which the commissioning company was interested in. The author focused on these questions in order to keep the study beneficial to Amer Sports. The companies chosen for the benchmarking were selected by the company with regard to their previous research. The research is beneficial and impo...

  1. Pharmacokinetic studies of neuromuscular blocking agents: Good Clinical Research Practice (GCRP)

    DEFF Research Database (Denmark)

    Viby-Mogensen, J.; Østergaard, D.; Donati, F.

    2000-01-01

    Good Clinical Research Practice (GCRP), neuromuscular blocking agents, pharmacokinetics, pharmacokinetic/pharmacodynamic modeling, population pharmacokinetics, statistics, study design......Good Clinical Research Practice (GCRP), neuromuscular blocking agents, pharmacokinetics, pharmacokinetic/pharmacodynamic modeling, population pharmacokinetics, statistics, study design...

  2. Intra-articular injection in patients with juvenile idiopathic arthritis: factors associated with a good response

    Directory of Open Access Journals (Sweden)

    Ana Luiza Garcia Cunha

    Full Text Available ABSTRACT Introduction: Intra-articular injection of corticosteroids (IIC for treatment of patients with juvenile idiopathic arthritis (JIA is increasingly used in Pediatric Rheumatology. Objectives: To describe the clinical course of patients undergoing IIC in our Pediatric Rheumatology Unit. Methods: Retrospective study of patients with JIA undergoing IIC from January 2008 to December 2012, with a minimum follow-up of six months after the injection. Good response to IIC was set as the presence of inactivity on the infiltrated joint by at least six months. Results: Eighty-eight patients underwent a total of 165 IICs. Of these, 75% were girls and 35.2% had persistent oligoarticular JIA. The mean age at diagnosis was 6.8 years, and when IIC was carried out, 12.2 years. Regarding patients, younger age at diagnosis (p = 0.037 and the occurrence of uveitis in the course of the disease (p = 0.015 were associated with good response to IIC. From 165 IICs, 63% had a good response and joints remained inactive for a median of 18.1 months. The type of joint injection (p = 0.001, lesser values stated in the overall visual analog scale by the physician (p = 0.015 and by parents/patient (p = 0.01 have been associated with a good response to IIC. Nine adverse events (5.4% were observed. Conclusion: In our study, more than half of the joints showed a good response to IIC. Younger patients at diagnosis and uveitis during the course of the disease had good response to IIC. Knees, wrists and elbows were the joints that best responded to IIC. IIC proved to be a safe procedure.

  3. Good partner, good parent: responsiveness mediates the link between romantic attachment and parenting style.

    Science.gov (United States)

    Millings, Abigail; Walsh, Judi; Hepper, Erica; O'Brien, Margaret

    2013-02-01

    This cross-sectional, dyadic questionnaire study examined the contribution of romantic attachment and responsive caregiving to parenting style, investigating both gender and partner effects. One hundred and twenty-five couples with children aged 7 to 8 years completed measures of attachment styles, responsive caregiving toward partner, and parenting styles. Structural Equation Modeling was used to examine the intra- and interpersonal associations between romantic attachment, caregiving responsiveness, and parenting styles. Attachment avoidance and anxiety were both negatively associated with responsive caregiving to partner, which in turn was positively associated with authoritative (optimal) parenting styles and negatively associated with authoritarian and permissive (nonoptimal) parenting styles. Responsive caregiving mediated all links between attachment and parenting, with an additional direct association between attachment anxiety and nonoptimal parenting styles that was not explained by caregiving responsiveness. Findings are discussed with reference to attachment theory.

  4. Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines.

    Science.gov (United States)

    Ravinetto, Raffaella; De Nys, Katelijne; Boelaert, Marleen; Diro, Ermias; Meintjes, Graeme; Adoke, Yeka; Tagbor, Harry; Casteels, Minne

    2015-12-30

    Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder's policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a "sponsor" of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today's reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other

  5. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2011-12-20

    ..., electronic record requirements, and investigator initiated research. Topics for discussion include the...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Clinical Research Associates (SoCRA), is announcing a public workshop. The public workshop on FDA's...

  6. Good Practice for Introducing Radiopharmaceuticals for Clinical Use

    International Nuclear Information System (INIS)

    2016-02-01

    The use of new radiopharmaceuticals can provide extremely valuable information in the evaluation of cancer, as well as heart and brain diseases. Information that often times cannot be obtained by other means. However, there is a perceived need in many Member States for a useful reference to facilitate and expedite the introduction of radiopharmaceuticals already in clinical use in other countries. This publication intends to provide practical support for the introduction of new radiotracers, including recommendations on the necessary steps needed to facilitate and expedite the introduction of radiopharmaceuticals in clinical use, while ensuring that a safe and high quality product is administered to the patient at all times

  7. Good Tax Governance: A Matter of Moral Responsibility and Transparency

    Directory of Open Access Journals (Sweden)

    Gribnau Hans J.L.M.

    2017-07-01

    Full Text Available Multinational corporations’ tax practices are hotly debated nowadays. Multinationals are accused of not paying their fair share of taxes. Apparently, acting within the limits set by law is not sufficient to qualify as morally responsible behavior anymore.

  8. A Good IDS Response Protocol of MANET Containment Strategies

    Science.gov (United States)

    Cheng, Bo-Chao; Chen, Huan; Tseng, Ryh-Yuh

    Much recent research concentrates on designing an Intrusion Detection System (IDS) to detect the misbehaviors of the malicious node in MANET with ad-hoc and mobility natures. However, without rapid and appropriate IDS response mechanisms performing follow-up management services, even the best IDS cannot achieve the desired primary goal of the incident response. A competent containment strategy is needed to limit the extent of an attack in the Incident Response Life Cycle. Inspired by the T-cell mechanisms in the human immune system, we propose an efficient MANET IDS response protocol (T-SecAODV) that can rapidly and accurately disseminate alerts of the malicious node attacks to other nodes so as to modify their AODV routing tables to isolate the malicious nodes. Simulations are conducted by the network simulator (Qualnet), and the experiment results indicate that T-SecAODV is able to spread alerts steadily while greatly reduce faulty rumors under simultaneous multiple malicious node attacks.

  9. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2011-08-17

    ... requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical...

  10. Alcohol as Good Food: Adolescents' Responses to Liqueur Ads.

    Science.gov (United States)

    Neuendorf, Kimberly A.; Pearlman, Reid A.

    Examining responses to print alcohol advertisements, a study questioned whether alcohol advertisers distinguish between "hard" and "soft" liquors (e.g. wine coolers and liqueurs). Subjects, 102 junior and senior high school students in a major metropolitan area, were asked to examine one set of three ads--either hard liquor ads…

  11. Good tax governance : A matter of moral responsibility and transparency

    NARCIS (Netherlands)

    Gribnau, Hans; Jallai, Ave-Geidi

    2017-01-01

    Multinational corporations’ tax practices are hotly debated nowadays. Multinationals are accused of not paying their fair share of taxes. Apparently, acting within the limits set by law is not sufficient to qualify as morally responsible behavior anymore. This article offers ethical reflection on

  12. Response: Freedom from Pain as a Rawlsian Primary Good.

    Science.gov (United States)

    James Roberts, Adam

    2016-11-01

    In a recent article in this journal, Carl Knight and Andreas Albertsen argue that Rawlsian theories of distributive justice as applied to health and healthcare fail to accommodate both palliative care and the desirability of less painful treatments. The asserted Rawlsian focus on opportunities or capacities, as exemplified in Normal Daniels' developments of John Rawls' theory, results in a normative account of healthcare which is at best only indirectly sensitive to pain and so unable to account for the value of efforts of which the sole purpose is pain reduction. I argue that, far from undermining the Rawlsian project and its application to problems of health, what the authors' argument at most amounts to is a compelling case for the inclusion of freedom from physical pain within its index of primary goods. © 2016 John Wiley & Sons Ltd.

  13. What makes a good clinical student and teacher? An exploratory study

    OpenAIRE

    Goldie, John; Dowie, Al; Goldie, Anne; Cotton, Phil; Morrison, Jill

    2015-01-01

    Background What makes a good clinical student is an area that has received little coverage in the literature and much of the available literature is based on essays and surveys. It is particularly relevant as recent curricular innovations have resulted in greater student autonomy. We also wished to look in depth at what makes a good clinical teacher. \\ud \\ud Methods A qualitative approach using individual interviews with educational supervisors and focus groups with senior clinical students w...

  14. Good tax governance: A matter of moral responsibility and transparency

    OpenAIRE

    Gribnau, Hans; Jallai, Ave-Geidi

    2017-01-01

    Multinational corporations’ tax practices are hotly debated nowadays. Multinationals are accused of not paying their fair share of taxes. Apparently, acting within the limits set by law is not sufficient to qualify as morally responsible behavior anymore. This article offers ethical reflection on the current debate.The general public typically evaluates (aggressive) tax planning in moral terms rather than legal terms. Therefore, multinationals need to reflect on their tax planning strategy ne...

  15. Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care

    Directory of Open Access Journals (Sweden)

    Paola Frati

    2017-01-01

    Full Text Available The latest research achievements in the field of stem cells led in 2016 to the publication of “Guidelines for Stem Cell Research and Clinical Translation” by the International Society for Stem Cell Research (ISSCR. Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient’s welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.

  16. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2010-03-25

    ... requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Society of Clinical Research Associates, Inc. (SoCRA) is announcing a public workshop entitled ``FDA...

  17. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2012-02-15

    ..., electronic record requirements, and investigator initiated research. Topics for discussion include the...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial...

  18. Surviving a Site Audit: Tips for Good Clinical Practice in an Implant Trial

    NARCIS (Netherlands)

    E.M.M. van Lieshout (Esther); S.M. Zielinski (Stephanie)

    2009-01-01

    textabstractAbstract The number of clinical trials involving implants for trauma and orthopedic surgery is increasing. The International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guideline has been developed in order to assure that the rights, safety, and well-being of trial

  19. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Science.gov (United States)

    2012-08-16

    ... include the following: (1) Are We There Yet?; (2) What FDA Expects in a Pharmaceutical Clinical Trial; (3) Medical Device Aspects of Clinical Research; (4) Adverse Event Reporting--Science, Regulation, Error, and...

  20. Doing well by doing good. The 7 benefits of a meaningful corporate social responsibility program.

    Science.gov (United States)

    Macdonald, Deborah

    2008-08-01

    You want your medical group to be a good community player--but you need to attract new patients, retain top staff and manage your bottom line. A corporate social responsibility program may be the shrewd solution.

  1. Dose-response relationship in clinical oncology

    International Nuclear Information System (INIS)

    Gehan, E.A.

    1984-01-01

    The relationship of dose (and dose rate) to response and toxicity in clinical oncology is reviewed. The concepts expressed by some authors in dose-response studies in animal and human systems are reviewed briefly. Dose rate and tactics of conducting clinical studies are reviewed for both radiotherapy and various types of chemotherapeutic treatment. Examples are given from clinical studies in Hodgkin's disease, acute leukemia, and breast cancer that may prove useful in planning future clinical studies

  2. Differences in autonomic physiological responses between good and poor inductive reasoners.

    Science.gov (United States)

    Melis, C; van Boxtel, A

    2001-11-01

    We investigated individual- and task-related differences in autonomic physiological responses induced by time limited figural and verbal inductive reasoning tasks. In a group of 52 participants, the percentage of correctly responded task items was evaluated together with nine different autonomic physiological response measures and respiration rate (RR). Weighted multidimensional scaling analyses of the physiological responses revealed three underlying dimensions, primarily characterized by RR, parasympathetic, and sympathetic activity. RR and sympathetic activity appeared to be relatively more important response dimensions for poor reasoners, whereas parasympathetic responsivity was relatively more important for good reasoners. These results suggest that poor reasoners showed higher levels of cognitive processing intensity than good reasoners. Furthermore, for the good reasoners, the dimension of sympathetic activity was relatively more important during the figural than during the verbal reasoning task, which was explained in terms of hemispheric lateralization in autonomic function.

  3. HSP60 may predict good pathological response to neoadjuvant chemoradiotherapy in bladder cancer

    International Nuclear Information System (INIS)

    Urushibara, Masayasu; Kageyama, Yukio; Akashi, Takumi; Otsuka, Yukihiro; Takizawa, Touichiro; Koike, Morio; Kihara, Kazunori

    2007-01-01

    Heat shock proteins (HSPs) play crucial roles in cellular responses to stressful conditions. Expression of HSPs in invasive or high-risk superficial bladder cancer was investigated to identify whether HSPs predict pathological response to neoadjuvant chemoradiotherapy (CRT). Immunohistochemistry was used to assess expression levels of HSP27, HSP60, HSP70, HSP90 and p53 in 54 patients with invasive or high-risk superficial bladder cancer, prior to low-dose neoadjuvant CRT, followed by radical or partial cystectomy. Patients were classified into two groups (good or poor responders) depending on pathological response to CRT, which was defined as the proportion of morphological therapeutic changes in surgical specimens. Good responders showed morphological therapeutic changes in two-thirds or more of tumor tissues. In contrast, poor responders showed changes in less than two-thirds of tumor tissues. Using a multivariate analysis, positive HSP60 expression prior to CRT was found to be marginally associated with good pathological response to CRT (P=0.0564). None of clinicopathological factors was associated with HSP60 expression level. In the good pathological responders, the 5-year cause-specific survival was 88%, which was significantly better than survival in the poor responders (51%) (P=0.0373). Positive HSP60 expression prior to CRT may predict good pathological response to low-dose neoadjuvant CRT in invasive or high-risk superficial bladder cancer. (author)

  4. The Meaning of Goodness-of-Fit Tests: Commentary on "Goodness-of-Fit Assessment of Item Response Theory Models"

    Science.gov (United States)

    Thissen, David

    2013-01-01

    In this commentary, David Thissen states that "Goodness-of-fit assessment for IRT models is maturing; it has come a long way from zero." Thissen then references prior works on "goodness of fit" in the index of Lord and Novick's (1968) classic text; Yen (1984); Drasgow, Levine, Tsien, Williams, and Mead (1995); Chen and…

  5. Responsiveness of Clinical Outcome Measures

    DEFF Research Database (Denmark)

    Lauridsen, Henrik Hein

    Background The Oswestry Disability Index (ODI) is one of two standardised functional health measurement scales (HMS) recommended. Despite extensive psychometric testing, little is known about HMS behaviour and the minimal clinically important difference (MCID) in subgroups of LBP patients. Moreover...... obtainable by a certain treatment. Chronic LBP patients seem to have a reasonable idea of an acceptable change in pain but overestimate change in functional and psychological /affective domains....

  6. Student teachers can be as good as associate professors in teaching clinical skills

    DEFF Research Database (Denmark)

    Tolsgaard, Martin G; Gustafsson, Amandus; Rasmussen, Maria B

    2007-01-01

    AIM: The aim of this study is to compare student teachers and clinical associate professors regarding the quality of procedural skills teaching in terms of participants' technical skills, knowledge and satisfaction with the teaching. METHODS: This is an experimental, randomized, controlled study....... CONCLUSION: Trained student teachers can be as good as associate professors in teaching clinical skills. Udgivelsesdato: 2007-Sep...... comparing the teaching of student teachers and associate professors regarding participants' learning outcome and satisfaction with the teaching. Two skills are chosen for the experiment, i.v.-access and bladder catheterization. Learning outcome is assessed by a pre- and post testing of the participants...

  7. Tools to share good chairside teaching practice: a clinical scenario and appreciative questionnaire.

    Science.gov (United States)

    Sweet, J; Wilson, J; Pugsley, L; Schofield, M

    2008-12-13

    This article provides a scenario for analysis of good chairside teaching practice to serve as a starting point for continued discussion in this complex field. Documented issues of good chairside teaching practice are cross-referenced to a clinical scenario with explanations in the form of a commentary. This provided the context for generating a set of questions that are provided as tools to support good chairside practice. These tools are designed to be used with 'Appreciative Inquiry', which claims that there is much to be gained by discovering where excellence is possible and elaborating upon this. Although this process can be carried out in single units or departments, it is proposed that collaboration between institutions would allow sharing of valuable innovations and greater understanding of educational training, production of good practice guidance and professional development of staff. This article is the third in a series of three and provides a scaffold for a scenario and questions to encourage collaboration in evolving and sharing good chairside teaching practice. The first article investigated the perceptions of stakeholders in chairside teaching at a single dental school and the second evaluated chairside teaching on a UK wide scale. A further accompanying article reviews some of the educational methodology and innovations in teaching and learning that may be applied to dentistry.

  8. Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

    Science.gov (United States)

    Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

    2012-01-01

    Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

  9. Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.

    Science.gov (United States)

    Micoulaud-Franchi, J-A; McGonigal, A; Lopez, R; Daudet, C; Kotwas, I; Bartolomei, F

    2015-12-01

    The technique of electroencephalographic neurofeedback (EEG NF) emerged in the 1970s and is a technique that measures a subject's EEG signal, processes it in real time, extracts a parameter of interest and presents this information in visual or auditory form. The goal is to effectuate a behavioural modification by modulating brain activity. The EEG NF opens new therapeutic possibilities in the fields of psychiatry and neurology. However, the development of EEG NF in clinical practice requires (i) a good level of evidence of therapeutic efficacy of this technique, (ii) a good practice guide for this technique. Firstly, this article investigates selected trials with the following criteria: study design with controlled, randomized, and open or blind protocol, primary endpoint related to the mental and brain disorders treated and assessed with standardized measurement tools, identifiable EEG neurophysiological targets, underpinned by pathophysiological relevance. Trials were found for: epilepsies, migraine, stroke, chronic insomnia, attentional-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, major depressive disorder, anxiety disorders, addictive disorders, psychotic disorders. Secondly, this article investigates the principles of neurofeedback therapy in line with learning theory. Different underlying therapeutic models are presented didactically between two continua: a continuum between implicit and explicit learning and a continuum between the biomedical model (centred on "the disease") and integrative biopsychosocial model of health (centred on "the illness"). The main relevant learning model is to link neurofeedback therapy with the field of cognitive remediation techniques. The methodological specificity of neurofeedback is to be guided by biologically relevant neurophysiological parameters. Guidelines for good clinical practice of EEG NF concerning technical issues of electrophysiology and of learning are suggested. These require validation by

  10. Moral identity and the experience of moral elevation in response to acts of uncommon goodness.

    Science.gov (United States)

    Aquino, Karl; McFerran, Brent; Laven, Marjorie

    2011-04-01

    Four studies using survey and experimental designs examined whether people whose moral identity is highly self-defining are more susceptible to experiencing a state of moral elevation after being exposed to acts of uncommon moral goodness. Moral elevation consists of a suite of responses that motivate prosocial action tendencies. Study 1 showed that people higher (vs. lower) in moral identity centrality reported experiencing more intense elevating emotions, had more positive views of humanity, and were more desirous of becoming a better person after reading about an act of uncommon goodness than about a merely positive situation or an act of common benevolence. Study 2 showed that those high in moral identity centrality were more likely to recall acts of moral goodness and experience moral elevation in response to such events more strongly. These experiences were positively related to self-reported prosocial behavior. Study 3 showed a direct effect on behavior using manipulated, rather than measured, moral identity centrality. Study 4 replicated the effect of moral identity on the states of elevation as well as on self-reported physical sensations and showed that the elevation mediates the relationship between moral identity, witnessing uncommon goodness, and prosocial behavior.

  11. The responsibility of technology. Weighting goods - risk assessment - codes of conduct

    International Nuclear Information System (INIS)

    Lenk, H.; Maring, M.

    1991-01-01

    Under the heading 'The responsibility of technology' nineteen authors contribute to the following topics: Basic questions of weighting 'goods' relating to resources, the relationship of technical possibilities and (self)restraint of individuals and collectives, striving for knowledge and appropriate limits, possibilities of directing and influencing technology and questions concerning (the limits of) individual and collective responsibility. Dealt with in more detail are: The assessment of technical risks and uncertainties from an ethical and legal point of view, problems in nuclear research and technology illustrated by the example of Chernobyl, information technology, and the influence of the press when presenting technology matters. (orig./HSCH) [de

  12. "It feels good to be measured": clinical role-play, Walker Percy, and the tingles.

    Science.gov (United States)

    Ahuja, Nitin K

    2013-01-01

    A large online community has recently formed around autonomous sensory meridian response (ASMR), a pleasant and poorly understood somatic reaction to specific interpersonal triggers. Its web-based manifestations include a variety of amateur videos designed to elicit the reaction, many of which feature protracted imitations of a clinician's physical exam. This analysis considers through a literary lens the proximity of this phenomenon to clinical diagnostics, focusing in particular on characterizations of spiritual isolation elaborated in Love in the Ruins (1971), the third novel by physician-writer Walker Percy (1916-1990). Within this speculative framework, the tendency to derive pleasure from clinical milieus, real or constructed, may be interpreted as a quality particular to the postmodern psyche. Viewing web-based clinical role-play in light of Percy's writing also underscores the possibility that routine diagnostic assessments may have independent therapeutic implications.

  13. Metastatic cervical lymphadenopathy from uterine leiomyosarcoma with good local response to radiotherapy and chemotherapy

    International Nuclear Information System (INIS)

    Oh, Yoon Kyeong; Park, Hee Chul; Kee, Keun Hong; Jeon, Ho Jong; Park, You Hwan; Chung, Choon Hai

    2000-01-01

    The metastasis of uterine leiomyosarcoma to the neck node has not been reported previously and the radiotherapy has been rarely used for the metastatic lesion of the other sites. We report a case of neck metastasis from a uterine leiomyosarcoma, which developed 10 months after surgery and postoperative pelvic radiotherapy. It also involved the parapharyngeal space, adjacent spine, and spinal canal. The metastatic neck mass was inoperable, and was treated by neck radiotherapy (6,000 cGy) and chemotherapy including taxol and carboplatin. The mass has regressed progressively to a nearly impalpable state. She has never developed spinal cord compression syndrome, and has maintained good swallowing for eight months since the neck radiotherapy and chemotherapy. Since the extensive metastatic neck mass showed good local response to high dose radiotherapy and chemotherapy, both treatments may be considered for an unresectable metastatic leiomyosarcoma

  14. Responsiveness and minimal clinically important change

    DEFF Research Database (Denmark)

    Christiansen, David Høyrup; Frost, Poul; Falla, Deborah

    2015-01-01

    Study Design A prospective cohort study nested in a randomized controlled trial. Objectives To determine and compare responsiveness and minimal clinically important change of the modified Constant score (CS) and the Oxford Shoulder Score (OSS). Background The OSS and the CS are commonly used...... to assess shoulder outcomes. However, few studies have evaluated the measurement properties of the OSS and CS in terms of responsiveness and minimal clinically important change. Methods The study included 126 patients who reported having difficulty returning to usual activities 8 to 12 weeks after...... were observed for the CS and the OSS. Minimal clinically important change ROC values were 6 points for the OSS and 11 points for the CS, with upper 95% cutoff limits of 12 and 22 points, respectively. Conclusion The CS and the OSS were both suitable for assessing improvement after decompression surgery....

  15. HiSCR (Hidradenitis Suppurativa Clinical Response)

    DEFF Research Database (Denmark)

    Kimball, B. A.; Sobell, J. M.; Zouboulis, C C

    2016-01-01

    Background: Determining treatment response for patients with hidradenitis suppurativa (HS) can be challenging due to limitations of current disease activity evaluations. Objective: Evaluate the novel, validated endpoint, Hidradenitis Suppurativa Clinical Response (HiSCR) and its utility as an out......Background: Determining treatment response for patients with hidradenitis suppurativa (HS) can be challenging due to limitations of current disease activity evaluations. Objective: Evaluate the novel, validated endpoint, Hidradenitis Suppurativa Clinical Response (HiSCR) and its utility...... as an outcome measure. Methods: Patients with baseline total abscess and inflammatory nodule count (AN count) of at least three and draining fistula count of 20 or fewer comprised the post hoc subpopulation analysed. HiSCR (at least a 50% reduction in total AN count, with no increase in abscess count...... week, or placebo (1 : 1 : 1). Results: The subpopulation included 132 (85.7%) patients; 70.5% women and 73.5% white. At week 16, HiSCR was achieved by 54.5% receiving weekly adalimumab, 33.3% every other week, and 25.6% placebo and HS-PGA Response was achieved by 20.5% receiving weekly adalimumab, 6...

  16. GOOD CORPORATE GOVERNANCE DAN PENGARUHNYA TERHADAP NILAI PERUSAHAAN MELALUI CORPORATE SOCIAL RESPONSIBILITY DISCLOSURE

    Directory of Open Access Journals (Sweden)

    I Gusti Ayu Purnamawati

    2017-04-01

    Full Text Available This research explained the relationship between Good Corporate Governance mechanism to company’s value, and the extent disclosure of Corporate Social Responsibility as moderation variable. Hierarchical regression analysis was used to examine modernization impact in the relationship between dependent and independent variable. Sample gathering was undertaken from 2012 to 2014. Tobin’s Q was used to assess the company’s value. Whereas Good Corporate Governance mechanism that was proxy by the number of managerial ownership and institutional ownership quantity was taken from ownership scale existed in company financial report. Extent measurement of Corporate Social Responsibility expressing was carried out by calculating each company’s CSR Index. This research used 44 samples of manufacturing companies meeting the criteria of purposive sampling. The testing of moderation effect and the main effect in the research was done using hierarchical regression analysis. The result showed that there were positive and significant relationship between GCG mechanism and company value, whereas between CSR extent disclosure and company value there was insignificant result. For examining the moderation impacts, CSR extent disclosure succeeded to moderate the relationship between managerial ownership and company value, but the extent of CSR expression did not succeed in moderating the relationship between institutional ownership and company value.

  17. 'Screening audit' as a quality assurance tool in good clinical practice compliant research environments.

    Science.gov (United States)

    Park, Sinyoung; Nam, Chung Mo; Park, Sejung; Noh, Yang Hee; Ahn, Cho Rong; Yu, Wan Sun; Kim, Bo Kyung; Kim, Seung Min; Kim, Jin Seok; Rha, Sun Young

    2018-04-25

    With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice (GCP) and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process (a screening audit) and evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital's Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. RESULTS: Investigator reply rates gradually increased, except for the first year (73% → 26% → 53% → 49% → 55%). The studies were graded as "critical," "major," "minor," and "not a finding" (11.9, 39.0, 42.9, and 6.3%, respectively), based on findings and number of deficiencies. The auditors' decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being "major" or "critical" (p = 0.002, audit grade (p audit results of post-screening audit compliance checks in "non-responding" and "critical" studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to

  18. Trochleoplasty as a Solitary Treatment for Recurrent Patellar Dislocation Results in Good Clinical Outcome in Adolescents.

    Science.gov (United States)

    Camathias, Carlo; Studer, Katrin; Kiapour, Ata; Rutz, Erich; Vavken, Patrick

    2016-11-01

    The essential static patellar stabilizer is a normal-shaped trochlear groove. A dysplastic groove destabilizes the patella. Trochleoplasty approaches this underlying condition and reshapes the trochlea. However, studies have reported on trochleoplasty for revision cases or as accompanied by other interventions. The effect of trochleoplasty alone remains unexplained. To introduce trochleoplasty as a stand-alone treatment for recurrent patellar dislocation and to compare its pre- to postoperative functional and clinical variables. Case series; Level of evidence, 4. A trochleoplasty was performed in 50 knees (27 right) in 44 patients (30 females; mean ± SD age, 15.6 ± 2.0 years). The indication for surgery was recurrent patellar dislocation not responding to nonoperative treatment (>6 months), with types B through D dysplasia and closed or closing physes in adolescents aged 10 to 20 years. Assessment included J-sign and apprehension test, Kujala and Lysholm scores, patients' subjective assessment and activity level according to the International Knee Documentation Committee questionnaire, and patients' overall satisfaction. The Caton-Deschamps ratio and the lateral condyle index were measured. Pre- versus postoperative values were compared with a paired Wilcoxon signed-rank test. The minimum follow-up was 24 months (33 ± 10.6 months). The Kujala score improved from 71 preoperatively to 92 postoperatively (P debridement. In this study, trochleoplasty as a solitary treatment for recurrent patellofemoral dislocations in patients with trochlear dysplasia resulted in good clinical outcomes if severe torsional and axial malalignment was excluded. Kujala and Lysholm scores increased postoperatively, as well as subjective International Knee Documentation Committee assessment of outcomes, activity level, and overall satisfaction. © 2016 The Author(s).

  19. Correlation between sonographic diagnosis and histopathological results ofgallbladder poliposis in Good Hope Clinic 2008-2014

    Directory of Open Access Journals (Sweden)

    Emiliano Contreras Castro

    2016-02-01

    Full Text Available Objective: To determine the correlation between sonographic diagnosis and histopathological results of gallbladder polyposis and find the positive predictive value of ultrasound in the diagnosis of this pathology. Material and Methods: It is a non experimental, transversal, descriptive and correlational study with a sample composed of all patients operated with a diagnosis of gallbladder polyps in the Good Hope Clinic between the years 2008 and 2014. A total of 128 patients were observed. Histopathological and sonographic reports of these patients were reviewed and the statistical correlation of both studies was sought by the test of Spearman. Results: Reveals that 67,2% were females and 32,8% were males; the average age was 43,4 years; 74,2% presented polyps by histopathological examination, of which 94,7% were pseudopolyps, with 82 % cases of cholesterolpolyps, only 5,3% were true polyps (adenomas and none of them were malignant. The positive predictive value of ultrasound in the diagnosis of gallbladder polyposis was 74,21%. According to the Spearman coefficient the correlation between the number of polyps by ultrasonography and histopathology was low, direct and significant (Rho = 0,189; p = 0,032. Conclusions: We conclude that there is a correlation between the ultrasound diagnosis and histopathological result of gallbladder polyps and ultrasound can be considered a reliable method for the diagnosis of gallbladder polyps.

  20. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

    Science.gov (United States)

    2008-07-15

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

  1. Report on proton therapy according to good clinical practice at Hyogo Ion Beam Medical Center

    International Nuclear Information System (INIS)

    Murakami, Masao; Kagawa, Kazufumi; Hishikawa, Yoshio; Abe, Mitsuyuki

    2002-01-01

    The Hyogo Ion Beam Medical Center (HIBMC) is a hospital-based charged particle treatment facility. Having two treatment ion beams (proton and carbon) and five treatment rooms, it is a pioneer among particle institutes worldwide. In May 2001, proton therapy was started as a clinical study for patients with localized cancer originating in the head and neck, lung, liver, and prostate. The aim of this study was to investigate the safety, effectiveness, and stability of the treatment units and systems based on the evaluation of acute toxicity, tumor response, and working ratio of the machine, respectively. Six patients, including liver cancer in three, prostate cancer in two, and lung cancer in one, were treated. There was no cessation of therapy owing to machine malfunction. Full courses of proton therapy consisting of 154 portals in all six patients were given exactly as scheduled. None of the patients experienced severe acute reactions of more than grade 3 according to NCI-CTC criteria. Tumor response one month post-treatment was evaluable in five of the six patients, and was CR in 1 (prostate cancer), PR in 2 (lung cancer: 1, liver cancer: 1), and NC in 2 (liver cancer: 2). These results indicate that our treatment units and systems are safe and reliable enough for proton irradiation to be used for several malignant tumors localized in the body. (author)

  2. Steps toward a shared governance response for achieving Good Environmental Status in the Mediterranean Sea

    Directory of Open Access Journals (Sweden)

    Sergio Cinnirella

    2014-12-01

    Full Text Available The Mediterranean region is of fundamental importance to Europe given its strategic position. The responsibility for its overall ecosystem integrity is shared by European Union Member States (EU-MS and other Mediterranean countries. A juxtaposition of overlapping governance instruments occurred recently in the region, with the implementation of both the Marine Strategy Framework Directive (MSFD for EU-MS and the Ecosystem Approach Strategy (ECAP for all Mediterranean countries, including EU-MS. Both MSFD and ECAP are structured around vision-driven processes to achieve Good Environmental Status and a Healthy Environment, respectively. These processes have clear ecosystem-based, integrated policy objectives to guarantee the preservation and integrity of Mediterranean marine ecosystem goods and services. However, adoption of these instruments, especially those related to the new EU-MS directives on marine policy, could result in a governance gap in addition to the well-known economic gap between the EU and the non-EU political blocs. We identify two complementary requirements for effective implementation of both MSFD and ECAP that could work together to reduce this gap, to ensure a better alignment between MSFD and ECAP and better planning for stakeholder engagement. These are key issues for the future success of these instruments in a Mediterranean region where discrepancies between societal and ecological objectives may pose a challenge to these processes.

  3. Unraveling Brazilian Indian population prostate good health: clinical, anthropometric and genetic features

    Directory of Open Access Journals (Sweden)

    Mario M. de Lima Junior

    2015-04-01

    Full Text Available Purpose To compare dietary, lifestyle, clinical, anthropometric, genetic and prostatic features of Brazilian Indians and non-Indians (Amazon. Methods 315 men, 228 Indians and 89 non-Indians, ≥40 years old were submitted to digital rectal examination, serum prostate specific antigen (PSA, testosterone, TP53 and GSTP1 genotyping, anthropometric, lifestyle, dietary, personal and familial medical history. Prostatic symptoms were evaluated with the International Prostate Symptom Score (IPSS. Results Macuxis and Yanomamis represented 43.6% and 14.5% of Indians respectively who spontaneously referred no prostate symptoms. Mean IPSS was 7, range 3-19, with only 15% of moderate symptoms (score 8-19; Mean age was 54.7 years, waist circumference 86.6 cm, BMI 23.9 kg/m2. Yanomamis presented both lower BMI (21.4 versus 24.8 and 23.3, p=0,001 and prostate volume than Macuxis and “other ethnic groups” (15 versus 20, p=0.001. Testosterone (414 versus 502 and 512, p=0.207 and PSA (0.48 versus 0.6 and 0.41, p=0.349 were similar with progressive PSA increase with aging. Val/Val correlated with lower PSA (p=0.0361. Indians compared to control population presented: - TP53 super representation of Arg/Arg haplotype, 74.5% versus 42.5%, p<0.0001. -GSTP1 Ile/Ile 35.3% versus 60.9%; Ile/Val 45.9% versus 28.7%; Val/Val 18.8% versus 10.3%; p=0.0003. Conclusions Observed specific dietary, lifestyle, anthropometric and genetic profile for TP53 and GSTP1 may contribute to Brazilian Indian population prostate good health.

  4. Unraveling Brazilian Indian population prostate good health: clinical, anthropometric and genetic features

    Science.gov (United States)

    de Lima, Mario M.; Reis, Leonardo O.; Ferreira, Ubirajara; Cardoso, Ulieme Oliveira; Barbieri, Raquel Bueno; de Mendonça, Gustavo B.; Ward, Laura S.

    2015-01-01

    Purpose To compare dietary, lifestyle, clinical, anthropometric, genetic and prostatic features of Brazilian Indians and non-Indians (Amazon). Methods 315 men, 228 Indians and 89 non-Indians, ≥40 years old were submitted to digital rectal examination, serum prostate specific antigen (PSA), testosterone, TP53 and GSTP1 genotyping, anthropometric, lifestyle, dietary, personal and familial medical history. Prostatic symptoms were evaluated with the International Prostate Symptom Score (IPSS). Results Macuxis and Yanomamis represented 43.6% and 14.5% of Indians respectively who spontaneously referred no prostate symptoms. Mean IPSS was 7, range 3-19, with only 15% of moderate symptoms (score 8-19); Mean age was 54.7 years, waist circumference 86.6 cm, BMI 23.9 kg/m2. Yanomamis presented both lower BMI (21.4 versus 24.8 and 23.3, p=0,001) and prostate volume than Macuxis and “other ethnic groups” (15 versus 20, p=0.001). Testosterone (414 versus 502 and 512, p=0.207) and PSA (0.48 versus 0.6 and 0.41, p=0.349) were similar with progressive PSA increase with aging. Val/Val correlated with lower PSA (p=0.0361). Indians compared to control population presented: - TP53 super representation of Arg/Arg haplotype, 74.5% versus 42.5%, p<0.0001. -GSTP1 Ile/Ile 35.3% versus 60.9%; Ile/Val 45.9% versus 28.7%; Val/Val 18.8% versus 10.3%; p=0.0003. Conclusions Observed specific dietary, lifestyle, anthropometric and genetic profile for TP53 and GSTP1 may contribute to Brazilian Indian population prostate good health. PMID:26005978

  5. Establishing good collaborative research practices in the responsible conduct of research in nursing science.

    Science.gov (United States)

    Ulrich, Connie M; Wallen, Gwenyth R; Cui, Naixue; Chittams, Jesse; Sweet, Monica; Plemmons, Dena

    2015-01-01

    Team science is advocated to speed the pace of scientific discovery, yet the goals of collaborative practice in nursing science and the responsibilities of nurse stakeholders are sparse and inconclusive. The purpose of this study was to examine nurse scientists' views on collaborative research as part of a larger study on standards of scientific conduct. Web-based descriptive survey of nurse scientists randomly selected from 50 doctoral graduate programs in the United States. Nearly forty percent of nurse respondents were not able to identify good collaborative practices for the discipline; more than three quarters did not know of any published guidelines available to them. Successful research collaborations were challenged by different expectations of authorship and data ownership, lack of timeliness and communication, poorly defined roles and responsibilities, language barriers, and when they involve junior and senior faculty working together on a project. Individual and organizational standards, practices, and policies for collaborative research needs clarification within the discipline. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. The thyroid-related quality of life measure ThyPRO has good responsiveness and ability to detect relevant treatment effects

    DEFF Research Database (Denmark)

    Watt, Torquil; Cramon, Per; Hegedüs, Laszlo

    2014-01-01

    responsiveness of the thyroid-related quality of life (QoL) instrument ThyPRO in patients undergoing relevant clinical treatments for benign thyroid diseases and to compare it with responsiveness of the generic SF-36 Health Survey. METHODS: A sample of 435 patients undergoing treatment completed the ThyPRO...... nontoxic goiter treated with surgery or radioactive iodine and remaining euthyroid (n = 62). Changes in QoL were evaluated in terms of effect size and compared to the changes predicted by clinical experts. The responsiveness of equivalent scales from ThyPRO and SF-36 Health Survey were compared...... with the relative validity index. RESULTS: The ThyPRO demonstrated good responsiveness across the whole range of QoL aspects in patients with hyper- and hypothyroidism. Responsiveness to treatment of nontoxic goiter was also demonstrated for physical and mental symptoms and overall QoL, but not for impact on social...

  7. RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH

    OpenAIRE

    REICHMAN, JEROME H.

    2009-01-01

    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “mark...

  8. Linking Biological Responses of Terrestrial N Eutrophication to the Final Ecosystem Goods and Services Classification System

    Science.gov (United States)

    Bell, M. D.; Clark, C.; Blett, T.

    2015-12-01

    The response of a biological indicator to N deposition can indicate that an ecosystem has surpassed a critical load and is at risk of significant change. The importance of this exceedance is often difficult to digest by policy makers and public audiences if the change is not linked to a familiar ecosystem endpoint. A workshop was held to bring together scientists, resource managers, and policy makers with expertise in ecosystem functioning, critical loads, and economics in an effort to identify the ecosystem services impacted by air pollution. This was completed within the framework of the Final Ecosystem Goods and Services (FEGS) Classification System to produce a product that identified distinct interactions between society and the effects of nitrogen pollution. From each change in a biological indicator, we created multiple ecological production functions to identify the cascading effects of the change to a measureable ecosystem service that a user interacts with either by enjoying, consuming, or appreciating the good or service, or using it as an input in the human economy. This FEGS metric was then linked to a beneficiary group that interacts with the service. Chains detailing the links from the biological indicator to the beneficiary group were created for aquatic and terrestrial acidification and eutrophication at the workshop, and here we present a subset of the workshop results by highlighting for 9 different ecosystems affected by terrestrial eutrophication. A total of 213 chains that linked to 37 unique FEGS metrics and impacted 15 beneficiary groups were identified based on nitrogen deposition mediated changes to biological indicators. The chains within each ecosystem were combined in flow charts to show the complex, overlapping relationships among biological indicators, ecosystem services, and beneficiary groups. Strength of relationship values were calculated for each chain based on support for the link in the scientific literature. We produced the

  9. Variation of topical application to skin under good clinical practice (GCP)

    DEFF Research Database (Denmark)

    Vind-Kezunovic, Dina; Serup, Jørgen Vedelskov

    2016-01-01

    INTRODUCTION: Application of topical products by individuals is inherently variable and accurate dosing can be difficult to control. Variation of the dose used under optimal conditions in drug trials is unknown. METHODS: This trial was part of a double-blind, randomized, placebo-controlled good...

  10. Conducting feasibilities in clinical trials: An investment to ensure a good study

    Directory of Open Access Journals (Sweden)

    Viraj Rajadhyaksha

    2010-01-01

    Full Text Available Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

  11. Conducting feasibilities in clinical trials: an investment to ensure a good study.

    Science.gov (United States)

    Rajadhyaksha, Viraj

    2010-07-01

    Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

  12. 'Good ethics and moral standing': a qualitative study of aesthetic leadership in clinical nursing practice.

    Science.gov (United States)

    Mannix, Judy; Wilkes, Lesley; Daly, John

    2015-06-01

    To explore how aesthetic leadership is embodied by clinical leaders in the nursing workplace. A number of different leadership styles have been developed, theorised and applied to the nursing workforce over the years. Many of these styles lack an explicit moral dimension in their identified leader attributes, due to a shift in theorising of leadership to focus on the impact of leader traits on followers. It is timely to look at aesthetic leadership, with its explicit moral dimension, as a way of improving outcomes for nurses, patients and health care organisations. Qualitative design, using conversation-style interviews with experienced registered nurses in designated clinical leadership roles. Twelve experienced registered nurses who worked in designated clinical leadership roles participated in an individual, digitally recorded, semi-structured conversation-style interview. Narrative data were transcribed and subject to thematic analysis. Three main themes emerged: 'True to their beliefs': embodying principled practice; 'Not all policies fit every patient': ethical leadership in ambiguous situations; and 'Being open to people's concerns': providing fair and just solutions. A strong moral compass shaped and guided participants' day-to-day clinical leadership activities. Participants provided a rich narrative on how aesthetic leadership is embodied in the clinical nursing setting. It was evident that their clinical leadership is shaped and guided by a strong moral compass. By incorporating into their practice an aesthetic world-view with its strong moral purpose, participants in this study have shown how aesthetic leadership can enhance the clinical nursing workplace. Nurses in the clinical setting value clinical leaders who embrace and operate with a strong moral compass. Aesthetic leadership, with its explicit strong moral purpose, offers a way of incorporating morality into clinical leadership in the nursing workplace. © 2015 John Wiley & Sons Ltd.

  13. Good practice in the management of amyotrophic lateral sclerosis: clinical guidelines. An evidence-based review with good practice points. EALSC Working Group.

    Science.gov (United States)

    Andersen, Peter Munch; Borasio, Gian Domenico; Dengler, Reinhard; Hardiman, Orla; Kollewe, Katja; Leigh, Peter Nigel; Pradat, Pierre-Francois; Silani, Vincenzo; Tomik, Barbara

    2007-08-01

    The evidence base for diagnosis and management of ALS is still weak, and curative therapy is lacking. Nonetheless, early diagnosis and symptomatic therapy can profoundly influence care and quality of life of the patient and relatives, and may increase survival time. This review addresses the current optimal clinical approach to ALS. The literature search is complete to December 2006. Where there was lack of evidence but consensus was clear we have stated our opinion as good practice points. We conclude that a diagnosis of ALS can be achieved by early examination by an experienced neurologist. The patient should be informed of the diagnosis by the consultant. Following diagnosis, a multi-diciplinary care team should support the patient and relatives. Medication with riluzole should be initiated as early as possible. PEG is associated with improved nutrition and should be inserted early. The operation is hazardous in patients with VC <50%: RIG may be a better alternative. Non-invasive positive pressure ventilation improves survival and quality of life but is underused in Europe. Maintaining the patient's ability to communicate is essential. During the course of the disease, every effort should be made to maintain patient autonomy. Advance directives for palliative end of life care are important and should be discussed early with the patient and relatives if they so wish.

  14. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2011-03-28

    ... initiated research. Topics for discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--Science, Regulation, Error, and Safety; (3) Part 11 Compliance...

  15. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2010-08-23

    ... discussion include the following: (1) What FDA expects in a pharmaceutical clinical trial; (2) adverse event reporting--science, regulation, error, and safety; (3) Part 11 Compliance--Electronic signatures; (4...

  16. What is good medical ethics? A very personal response to a difficult question.

    Science.gov (United States)

    Farsides, Bobbie

    2015-01-01

    A personal reflection upon a career in medical ethics leads to four conclusions on what makes for 'good medical ethics'. Good medical ethics is practical in approach, philosophically well grounded, cross disciplinary, and while it might not be a necessary feature, the experience of the author suggests that it is the work of 'good people'. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. Coffee consumption, metabolic syndrome and clinical severity of psoriasis: good or bad stuff?

    Science.gov (United States)

    Barrea, Luigi; Muscogiuri, Giovanna; Di Somma, Carolina; Annunziata, Giuseppe; Megna, Matteo; Falco, Andrea; Balato, Anna; Colao, Annamaria; Savastano, Silvia

    2018-05-01

    Despite the wide consumption of coffee, its anti-inflammatory effect on clinical severity of psoriasis is still debatable. The aim of this study was to evaluate the association between the coffee consumption and clinical severity of psoriasis in a sample of patients stratified according to the presence of the metabolic syndrome (MetS) and smoking. This cross-sectional case-control observational study was conducted on 221 treatment-naïve psoriatic patients. Lifestyle habits, anthropometric measures, clinical and biochemical evaluations were obtained. Clinical severity of psoriasis was assessed by Psoriasis Area and Severity Index (PASI) score. Data on energy caloric intake and coffee consumption were collected using a 7-day food diary record. The coffee consumption was analyzed as coffee intake (consumers and non-consumers) and daily servings (range 0-4 servings/day). Coffee consumers have a lower PASI score vs non-consumers (p < 0.001). The lowest PASI score and MetS prevalence were found in patients consuming 3 cups of coffee/day (p < 0.001), which was also the most common daily serving (34.8%), whereas the highest PASI score was found among those drinking ≥ 4 cups/day. Grouping the case patients according to smoking and MetS, the best odds of PASI score was observed in those drinking 3 cups of coffee per day and no smokers, after adjusting for total energy intake (OR 74.8; p < 0.001). As a novel finding, we reported a negative association between coffee intake, MetS prevalence and clinical severity of psoriasis. The evaluation of the anti-inflammatory effect of coffee on clinical severity of psoriasis, whose metabolic risk increases along with its clinical severity, could be of great importance from a public health perspective.

  18. Chromosome 17 alterations identify good-risk and poor-risk tumors independently of clinical factors in medulloblastoma

    Science.gov (United States)

    McCabe, Martin G.; Bäcklund, L. Magnus; Leong, Hui Sun; Ichimura, Koichi; Collins, V. Peter

    2011-01-01

    Current risk stratification schemas for medulloblastoma, based on combinations of clinical variables and histotype, fail to accurately identify particularly good- and poor-risk tumors. Attempts have been made to improve discriminatory power by combining clinical variables with cytogenetic data. We report here a pooled analysis of all previous reports of chromosomal copy number related to survival data in medulloblastoma. We collated data from previous reports that explicitly quoted survival data and chromosomal copy number in medulloblastoma. We analyzed the relative prognostic significance of currently used clinical risk stratifiers and the chromosomal aberrations previously reported to correlate with survival. In the pooled dataset metastatic disease, incomplete tumor resection and severe anaplasia were associated with poor outcome, while young age at presentation was not prognostically significant. Of the chromosomal variables studied, isolated 17p loss and gain of 1q correlated with poor survival. Gain of 17q without associated loss of 17p showed a trend to improved outcome. The most commonly reported alteration, isodicentric chromosome 17, was not prognostically significant. Sequential multivariate models identified isolated 17p loss, isolated 17q gain, and 1q gain as independent prognostic factors. In a historical dataset, we have identified isolated 17p loss as a marker of poor outcome and 17q gain as a novel putative marker of good prognosis. Biological markers of poor-risk and good-risk tumors will be critical in stratifying treatment in future trials. Our findings should be prospectively validated independently in future clinical studies. PMID:21292688

  19. RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH

    Science.gov (United States)

    REICHMAN, JEROME H.

    2009-01-01

    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “market exclusivity” and in Europe as “data exclusivity,” these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers’ undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers’ clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers’ consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the

  20. RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH.

    Science.gov (United States)

    Reichman, Jerome H

    2009-01-01

    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as "market exclusivity" and in Europe as "data exclusivity," these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers' undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers' clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers' consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the expense of public

  1. Good clinical outcomes from a 7-year holistic programme of fistula repair in Guinea

    Science.gov (United States)

    Delamou, Alexandre; Diallo, Moustapha; Beavogui, Abdoul Habib; Delvaux, Thérèse; Millimono, Sita; Kourouma, Mamady; Beattie, Karen; Barone, Mark; Barry, Thierno Hamidou; Khogali, Mohamed; Edginton, Mary; Hinderaker, Sven Gudmund; Ruminjo, Joseph; Zhang, Wei-Hong; De Brouwere, Vincent

    2015-01-01

    Objectives Female genital fistula remains a public health concern in developing countries. From January 2007 to September 2013, the Fistula Care project, managed by EngenderHealth in partnership with the Ministry of Health and supported by USAID, integrated fistula repair services in the maternity wards of general hospitals in Guinea. The objective of this article was to present and discuss the clinical outcomes of 7 years of work involving 2116 women repaired in three hospitals across the country. Methods This was a retrospective cohort study using data abstracted from medical records for fistula repairs conducted from 2007 to 2013. The study data were reviewed during the period April to August 2014. Results The majority of the 2116 women who underwent surgical repair had vesicovaginal fistula (n = 2045, 97%) and 3% had rectovaginal fistula or a combination of both. Overall 1748 (83%) had a closed fistula and were continent of urine immediately after surgery. At discharge, 1795 women (85%) had a closed fistula and 1680 (79%) were dry, meaning they no longer leaked urine and/or faeces. One hundred and fifteen (5%) remained with residual incontinence despite fistula closure. Follow-up at 3 months was completed by 1663 (79%) women of whom 1405 (84.5%) had their fistula closed and 80% were continent. Twenty-one per cent were lost to follow-up. Conclusion Routine programmatic repair for obstetric fistula in low resources settings can yield good outcomes. However, more efforts are needed to address loss to follow-up, sustain the results and prevent the occurrence and/or recurrence of fistula. Objectifs La fistule génitale féminine reste un problème de santé publique dans les pays en développement. De janvier 2007 à septembre 2013, le projet Fistula Care, géré par Engender Health en partenariat avec le Ministère de la Santé et soutenu par l’USAID, a intégré les services de réparation de fistules dans les maternités des hôpitaux généraux en Guin

  2. Clinical audit of leg ulceration prevalence in a community area: a case study of good practice.

    Science.gov (United States)

    Hindley, Jenny

    2014-09-01

    This article presents the findings of an audit on venous leg ulceration prevalence in a community area as a framework for discussing the concept and importance of audit as a tool to inform practice and as a means to benchmark care against national or international standards. It is hoped that the discussed audit will practically demonstrate how such procedures can be implemented in practice for those who have not yet undertaken it, as well as highlighting the unexpected extra benefits of this type of qualitative data collection that can often unexpectedly inform practice and influence change. Audit can be used to measure, monitor and disseminate evidence-based practice across community localities, facilitating the identification of learning needs and the instigation of clinical change, thereby prioritising patient needs by ensuring safety through the benchmarking of clinical practice.

  3. Looking good or doing better? Patterns of decoupling in the implementation of clinical directorates.

    Science.gov (United States)

    Mascia, Daniele; Morandi, Federica; Cicchetti, Americo

    2014-01-01

    The interest toward hospital restructuring has risen significantly in recent years. In spite of its potential benefits, often organizational restructuring in health care produces unexpected consequences. Extant research suggests that institutional theory provides a powerful theoretical lens through which hospital restructuring can be described and explained. According to this perspective, the effectiveness of change is strongly related to the extent to which innovative arrangements, tools, or practices are adopted and implemented within hospitals. Whenever these new arrangements require a substantial modification of internal processes and practices, resistance to implementation emerges and organizational change is likely to become neutralized. This study analyzes how hospital organizations engage in decoupling by adopting but not implementing a new organizational model named clinical directorate. We collected primary data on the diffusion of the clinical directorate model, which was mandated by law in the Italian National Health Service to improve hospital services. We surveyed the adoption and implementation of the clinical directorate model by monitoring the presence of clinical governance tools (measures for the quality improvement of hospital services) within single directorates. In particular, we compared hospitals that adopted the model before (early adopters) or after (later adopters) the mandate was introduced. Hospitals were engaged in decoupling by adopting the new arrangement but not implementing internal practices and tools for quality improvement. The introduction of the law significantly affected the decoupling, with late-adopter hospitals being less likely to implement the adopted model. The present research shows that changes in quality improvement processes may vary in relation to policy makers' interventions aimed at boosting the adoption of new hospital arrangements. Hospital administrators need to be aware and identify the institutional changes

  4. The characteristics of a good clinical teacher as perceived by resident physicians in Japan: a qualitative study.

    Science.gov (United States)

    Kikukawa, Makoto; Nabeta, Hiromi; Ono, Maiko; Emura, Sei; Oda, Yasutomo; Koizumi, Shunzo; Sakemi, Takanobu

    2013-07-25

    It is not known whether the characteristics of a good clinical teacher as perceived by resident physicians are the same in Western countries as in non-Western countries including Japan. The objective of this study was to identify the characteristics of a good clinical teacher as perceived by resident physicians in Japan, a non-Western country, and to compare the results with those obtained in Western countries. Data for this qualitative research were collected using semi-structured focus group interviews. Focus group transcripts were independently analyzed and coded by three authors. Residents were recruited by maximum variation sampling until thematic saturation was achieved. Twenty-three residents participated in five focus group interviews regarding the perceived characteristics of a good clinical teacher in Japan. The 197 descriptions of characteristics that were identified were grouped into 30 themes. The most commonly identified theme was "provided sufficient support", followed by "presented residents with chances to think", "provided feedback", and "provided specific indications of areas needing improvement". Using Sutkin's main categories (teacher, physician, and human characteristics), 24 of the 30 themes were categorized as teacher characteristics, 6 as physician characteristics, and none as human characteristics. "Medical knowledge" of teachers was not identified as a concern of residents, and "clinical competence of teachers" was not emphasized, whereas these were the two most commonly recorded themes in Sutkin's study. Our results suggest that Japanese and Western resident physicians place emphasis on different characteristics of their teachers. We speculate that such perceptions are influenced by educational systems, educational settings, and culture. Globalization of medical education is important, but it is also important to consider differences in educational systems, local settings, and culture when evaluating clinical teachers.

  5. Information Technology for Good (IT4G): Merging Information Technology with Social Responsibility

    Science.gov (United States)

    Saulnier, Bruce

    2013-01-01

    A case is made for a new approach to higher education in the 21st century, an approach in which the traditional majors are extended beyond their usual boundaries by applying one's education to address the public good. The LEAP initiative and the Learning Paradigm College are advanced as exemplars of effective 21st century educational practices,…

  6. Feedback is good or bad? Medical residents’ points of view on feedback in clinical education

    Directory of Open Access Journals (Sweden)

    LEILA BAZRAFKAN

    2013-04-01

    Full Text Available Introduction: Feedback is very important in education and can help quality in the training process and orient the trainees in clinical contexts. This study aimed to assess the residents’ points of view about feedback in clinical education at Shiraz University of Medical Sciences. Methods: The sample of this study included 170 medical residents attending medical workshops in Shiraz University of Medical Sciences. The residents filled a valid and reliable questionnaire containing 21 items on their perceptions of the feedback they got throughout the workshops. The data were analyzed using SPSS version 14. Results: The study revealed that residents, generally, have a positive perception of feedback in their training. The highest score belonged to the items such as “feedback was applicable to future work”, “feedback corrected my behavior”, “feedback worked as a motivation for education” and “feedback was specific in one subject”. Residents who had a negative feedback experience also increased their efforts to learn. The Surgery residents acquired the highest scores while radiology residents got the lowest. The difference between these groups was statistically significant (P = 0.000. Conclusion: The highest mean score belonged to internal medicine residents. This shows that residents believe that obstetrics & gynecology ward is a ward in which the formative assessment is much more powerful in comparison to the other three major wards. The surgery ward received the lowest score for formative assessment and this shows that the feedback in surgery ward is very low.

  7. Guidelines and good clinical practice recommendations for Contrast Enhanced Ultrasound (CEUS) in the liver - update 2012

    DEFF Research Database (Denmark)

    Claudon, Michel; Dietrich, Christoph F; Choi, Byung Ihn

    2013-01-01

    Initially, a set of guidelines for the use of ultrasound contrast agents was published in 2004 dealing only with liver applications. A second edition of the guidelines in 2008 reflected changes in the available contrast agents and updated the guidelines for the liver, as well as implementing some...... Medizin/European Journal of Ultrasound for EFSUMB). These guidelines and recommendations provide general advice on the use of all currently clinically available ultrasound contrast agents (UCA). They are intended to create standard protocols for the use and administration of UCA in liver applications...... non-liver applications. Time has moved on, and the need for international guidelines on the use of CEUS in the liver has become apparent. The present document describes the third iteration of recommendations for the hepatic use of contrast enhanced ultrasound (CEUS) using contrast specific imaging...

  8. [Population Council responsible for RU486 clinical trials in USA].

    Science.gov (United States)

    Aguillaume, C J

    1993-04-01

    As a result of the sudden political change that came with the Clinton Administration, RU-486's manufacturer, Roussel-Uclaf, and the Population Council agreed on April 20, 1992, on the manufacture and distribution of RU-486 in the US. In the US, there are less than 1.6 million induced abortions annually. From now on, US women will be able to have a choice between medical and surgical abortion. The Population Council and Roussel-Uclaf have had a contract since 1982. The Council is solely responsible for the phase 2 clinical trial of RU-486 in the US and other countries. It must present to the US Food and Drug Administration (FDA) an amendment allowing it to begin phase 3 clinical trials. The Council will also lead the US medical facilities in this study. It will identify partners for future production of RU-486 and its distribution in the US. It will also submit to FDA a New Drug Application (NDA). FDA will review the scientific literature on RU-486 and evaluate all data submitted by the Population Council. There are still obstacles to be surmounted. The Population Council must demonstrate good judgment when selecting the criteria for choosing a pharmaceutical firm before a Technical Committee which will be part of a group of players promoting women's health, scientific experts, and other interested parties. It must find the necessary funds to conduct the clinical trials and prepare the NDA. Phase 3 clinical trials in the US must have at least 2000 women. They will test RU-486's efficacy, safety, and acceptability among women choosing medical abortion over surgical abortion. Since the Council operates in almost all countries in the world, has innovated contraceptive research and development activities, and has been endorsed by the UN, product approval of RU-486 in the US will affect policy in all countries concerned about abortion.

  9. Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

    Science.gov (United States)

    Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

    2017-01-01

    A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of

  10. When not every response to climate change is a good one: identifying principles for sustainable adaptation

    CSIR Research Space (South Africa)

    Eriksen, S

    2011-01-01

    Full Text Available to the need for sustainable adaptation strategies and measures that contribute to social justice and environmental integrity. This paper presents four normative principles to guide responses to climate change and illustrates the significance...

  11. Doing Good Again? A Multilevel Institutional Perspective on Corporate Environmental Responsibility and Philanthropic Strategy

    OpenAIRE

    Liu, Wei; Wei, Qiao; Huang, Song-Qin; Tsai, Sang-Bing

    2017-01-01

    This study investigates the relationship between corporate environmental responsibility and corporate philanthropy. Using a sample of Chinese listed firms from 2008 to 2013, this paper examines the role of corporate environmental responsibility in corporate philanthropy and the moderating influence of the institutional environment using multilevel analysis. The results show that corporate eco-friendly events are positively associated with corporate philanthropic strategy to a significant degr...

  12. Educational climate seems unrelated to leadership skills of clinical consultants responsible of postgraduate medical education in clinical departments.

    Science.gov (United States)

    Malling, Bente; Mortensen, Lene S; Scherpbier, Albert J J; Ringsted, Charlotte

    2010-09-21

    The educational climate is crucial in postgraduate medical education. Although leaders are in the position to influence the educational climate, the relationship between leadership skills and educational climate is unknown. This study investigates the relationship between the educational climate in clinical departments and the leadership skills of clinical consultants responsible for education. The study was a trans-sectional correlation study. The educational climate was investigated by a survey among all doctors (specialists and trainees) in the departments. Leadership skills of the consultants responsible for education were measured by multi-source feedback scores from heads of departments, peer consultants, and trainees. Doctors from 42 clinical departments representing 21 specialties participated. The response rate of the educational climate investigation was moderate 52% (420/811), Response rate was high in the multisource-feedback process 84.3% (420/498). The educational climate was scored quite high mean 3.9 (SD 0.3) on a five-point Likert scale. Likewise the leadership skills of the clinical consultants responsible for education were considered good, mean 5.4 (SD 0.6) on a seven-point Likert scale. There was no significant correlation between the scores concerning the educational climate and the scores on leadership skills, r = 0.17 (p = 0.29). This study found no relation between the educational climate and the leadership skills of the clinical consultants responsible for postgraduate medical education in clinical departments with the instruments used. Our results indicate that consultants responsible for education are in a weak position to influence the educational climate in the clinical department. Further studies are needed to explore, how heads of departments and other factors related to the clinical organisation could influence the educational climate.

  13. PENGARUH GOOD CORPORATE GOVERNANCE, KARAKTERISTIK PERUSAHAAN TERHADAP LUAS PENGUNGKAPAN CORPORATE SOCIAL RESPONSIBILITY PADA PERUSAHAAN TERDAFTAR DI BEI

    Directory of Open Access Journals (Sweden)

    Alang Wiyuda

    2017-03-01

    Full Text Available Penelitian ini bertujuan untuk menguji pengaruh kepemilikan institusional, dewan komisaris, komite audit yang diprosikan kedalam good corporate governance dan profitabilitas, ukuran perusahaan, tipe industri (profile, leverage diprosikan kedalam karakteristik perusahaan terhadap luas pengungkapan corporate social responsibility. Variabel dependen yang digunakan dalam penelitian ini adalah luas pengungkapan corporate social responsibility, sedangkan variabel independenya adalah kepemilikan institusional, dewan komisaris, komite audit, profitabilitas, ukuran perusahaan, tipe industri (profile, leverage. Populasi dalam penelitian ini adalah perusahaan manufaktur yang terdaftar di Bursa Efek Indonesia tahun 2015. Sampel dalam penelitian ini dipilih menggunakan metode purposive sampling, dan diperoleh sebanyak 106 sampel amatan. Teknik analisis yang digunakan dalam penelitian ini adalah analisis linier berganda. Hasil analisis menunjukan bahwa variabel kepemilikan institusional, dewan komisaris, dan profitabilitas berpengaruh positif terhadap luas pengungkapan corporate social responsibility. Variabel komite audit berpengaruh negatif terhadap luas pengungkapan corporate social responsibility. Variabel ukuran perusahaan, tipe industri (profile, dan leverage tidak berpengaruh terhadap luas pengungkapan corporate social responsibility.

  14. 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.

  15. Doing Good Again? A Multilevel Institutional Perspective on Corporate Environmental Responsibility and Philanthropic Strategy

    Science.gov (United States)

    Liu, Wei; Wei, Qiao; Huang, Song-Qin

    2017-01-01

    This study investigates the relationship between corporate environmental responsibility and corporate philanthropy. Using a sample of Chinese listed firms from 2008 to 2013, this paper examines the role of corporate environmental responsibility in corporate philanthropy and the moderating influence of the institutional environment using multilevel analysis. The results show that corporate eco-friendly events are positively associated with corporate philanthropic strategy to a significant degree. Provincial-level government intervention positively moderate the positive relationship between eco-friendly events and corporate philanthropy and government corruption is negatively moderate the relationship. All these results are robust according to robustness checks. These findings provide a new perspective on corporate philanthropic strategy as a means to obtain critical resources from the government in order to compensate for the loss made on environmental responsibility. Moreover, the institutional environment is proved here to play an important role in corporate philanthropic strategy. PMID:29064451

  16. Doing Good Again? A Multilevel Institutional Perspective on Corporate Environmental Responsibility and Philanthropic Strategy.

    Science.gov (United States)

    Liu, Wei; Wei, Qiao; Huang, Song-Qin; Tsai, Sang-Bing

    2017-10-24

    This study investigates the relationship between corporate environmental responsibility and corporate philanthropy. Using a sample of Chinese listed firms from 2008 to 2013, this paper examines the role of corporate environmental responsibility in corporate philanthropy and the moderating influence of the institutional environment using multilevel analysis. The results show that corporate eco-friendly events are positively associated with corporate philanthropic strategy to a significant degree. Provincial-level government intervention positively moderate the positive relationship between eco-friendly events and corporate philanthropy and government corruption is negatively moderate the relationship. All these results are robust according to robustness checks. These findings provide a new perspective on corporate philanthropic strategy as a means to obtain critical resources from the government in order to compensate for the loss made on environmental responsibility. Moreover, the institutional environment is proved here to play an important role in corporate philanthropic strategy.

  17. Doing Good Again? A Multilevel Institutional Perspective on Corporate Environmental Responsibility and Philanthropic Strategy

    Directory of Open Access Journals (Sweden)

    Wei Liu

    2017-10-01

    Full Text Available This study investigates the relationship between corporate environmental responsibility and corporate philanthropy. Using a sample of Chinese listed firms from 2008 to 2013, this paper examines the role of corporate environmental responsibility in corporate philanthropy and the moderating influence of the institutional environment using multilevel analysis. The results show that corporate eco-friendly events are positively associated with corporate philanthropic strategy to a significant degree. Provincial-level government intervention positively moderate the positive relationship between eco-friendly events and corporate philanthropy and government corruption is negatively moderate the relationship. All these results are robust according to robustness checks. These findings provide a new perspective on corporate philanthropic strategy as a means to obtain critical resources from the government in order to compensate for the loss made on environmental responsibility. Moreover, the institutional environment is proved here to play an important role in corporate philanthropic strategy.

  18. Evaluation of Clinical and Pathological Response after Two Cycles ...

    African Journals Online (AJOL)

    Results: The clinical response rate was 83%; 11 patients (11.2%) had a complete clinical remission (cCR); 71 had a partial remission (72.4%); 13 had stable disease (13.3%), and 3 had progressive disease (3.1%). Seven patients had complete pathological response. Conclusion: Neoadjuvant chemotherapy can achieve a ...

  19. Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report.

    Science.gov (United States)

    Ramsey, Scott D; Willke, Richard J; Glick, Henry; Reed, Shelby D; Augustovski, Federico; Jonsson, Bengt; Briggs, Andrew; Sullivan, Sean D

    2015-03-01

    Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision

  20. [Learning during the early clinical years takes more than good study habits: Perceptions of students and teachers].

    Science.gov (United States)

    Zúñiga, Denisse; Leiva, Isabel; Calderón, Maribel; Tomicic, Alemka; Padilla, Oslando; Riquelme, Arnoldo; Bitran, Marcela

    2015-11-01

    Teaching methods of the undergraduate medical curriculum change considerably from the first years to clinical training. Clinical learning occurs in complex and varied scenarios while caring for patients. Students have to adapt their learning approaches and strategies to be able to integrate theory and clinical practice and become experiential learners. To identify the strategies used by medical students to learn during the initial clinical years, as reported by students themselves and by their clinical tutors. We performed eight focus group discussions with 54 students enrolled in years three to six and we interviewed eight clinical tutors. Both focus group discussions and interviews were audio recorded, transcribed and analyzed according to Grounded Theory. Four main themes were identified in the discourse of both students and tutors: Strategies oriented to theoretical learning, strategies oriented to experiential learning, strategies for integrating theory and practice and strategies oriented to evaluation. The mentioning of individual differences was present across the reports of both students and tutors. Students use a rich variety of strategies to face the challenges of clinical learning. Both students and tutors recognize that the learning approaches and strategies vary according the nature of the task and individual differences. The responses of students bring particular knowledge of the approaches used for the theoretical and practical integration and delve into the social dimension of learning.

  1. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

    Science.gov (United States)

    Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

    2016-12-12

    The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

  2. Differences in autonomic physiological responses between good and poor inductive reasoners

    NARCIS (Netherlands)

    Melis, C.J.; van Boxtel, A.

    2001-01-01

    We investigated individual- and task-related differences in autonomic physiological responses induced by time limited figural and verbal inductive reasoning tasks. In a group of 52 participants, the percentage of correctly responded task items was evaluated together with nine different autonomic

  3. "Good" Students and "Involved" Mothers: Latin@ Responses to Normalization Pressures in Schools

    Science.gov (United States)

    Cuero, Kimberley Kennedy; Valdez, Veronica E.

    2012-01-01

    Drawing from two in-depth qualitative studies, we used a sociocultural lens for a cross-case analysis examining how Latin@s' participation in schools is affected by ideological messages that subordinately position them in terms of their ethnicity, class, and immigrant status. We identified a range of dynamic responses to the school's normalization…

  4. Good and bad protons: genetic aspects of acidity stress responses in plants.

    Science.gov (United States)

    Shavrukov, Yuri; Hirai, Yoshihiko

    2016-01-01

    Physiological aspects of acidity stress in plants (synonymous with H(+) rhizotoxicity or low-pH stress) have long been a focus of research, in particular with respect to acidic soils where aluminium and H(+) rhizotoxicities often co-occur. However, toxic H(+) and Al(3+) elicit different response mechanisms in plants, and it is important to consider their effects separately. The primary aim of this review was to provide the current state of knowledge regarding the genetics of the specific reactions to low-pH stress in growing plants. A comparison of the results gleaned from quantitative trait loci analysis and global transcriptome profiling of plants in response to high proton concentrations revealed a two-stage genetic response: (i) in the short-term, proton pump H(+)-ATPases present the first barrier in root cells, allocating an excess of H(+) into either the apoplast or vacuole; the ensuing defence signaling system involves auxin, salicylic acid, and methyl jasmonate, which subsequently initiate expression of STOP and DREB transcription factors as well as chaperone ROF; (2) the long-term response includes other genes, such as alternative oxidase and type II NAD(P)H dehydrogenase, which act to detoxify dangerous reactive oxygen species in mitochondria, and help plants better manage the stress. A range of transporter genes including those for nitrate (NTR1), malate (ALMT1), and heavy metals are often up-regulated by H(+) rhizotoxicity. Expansins, cell-wall-related genes, the γ-aminobutyric acid shunt and biochemical pH-stat genes also reflect changes in cell metabolism and biochemistry in acidic conditions. However, the genetics underlying the acidity stress response of plants is complicated and only fragmentally understood. © The Author 2015. Published by Oxford University Press on behalf of the Society for Experimental Biology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  5. 42 CFR 493.1419 - Standard; Clinical consultant responsibilities.

    Science.gov (United States)

    2010-10-01

    ... Testing Laboratories Performing Moderate Complexity Testing § 493.1419 Standard; Clinical consultant... clinical consultation to the laboratory's clients; (b) Be available to assist the laboratory's clients in... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

  6. Dynamics of Corporates and Stakeholders Perspective of Corporate Social Responsibility: A Case of Sports Goods Industry Meerut

    OpenAIRE

    R. K. Tyagi

    2010-01-01

    Problem statement: The Corporate Social Responsibility concerns got global attention in large scale industries but the SMEs which are no less prone to create critical problems for the human, social and natural environments inimical to the society as a whole and survival at large, have not attracted the required attention. The case focuses on the dynamics of the corporate and stakeholder perspective on CSR in Sports Goods Industry Meerut. Approach: This study examined the corporate and stakeho...

  7. Applying Sustainability and Responsible Investment on Islamic Equity Investment: An Analysis of FTSE Shariah and FTSE4GOOD Indices

    OpenAIRE

    Rizki, Reza

    2015-01-01

    2015 dissertation for MSc Islamic Banking and Finance. Selected by academic staff as a good example of a masters level dissertation. \\ud \\ud Shariah-compliant Investment and Sustainability Responsible Investment (SRI) are the slternative asset classes and they are growing rapidly leaving their counterparts behind. Nonetheless, there are some criticisms against the screening criteria which are applied by Islamic equity investment because they exclude the environment, social and human rights is...

  8. Key drivers of 'good' corporate governance and the appropriateness of UK policy responses : final report

    OpenAIRE

    Filatotchev, Igor; Jackson, Gregory; Gospel, Howard; Allcock, Deborah

    2007-01-01

    The DTI’s Corporate Law and Governance strategy aims to promote and deliver an effective\\ud framework for corporate governance in the UK, giving confidence to investors, business, and\\ud other stakeholders to underpin the relationship between an organisation and those who hold\\ud future financial claims against that organisation. However, corporate governance involves\\ud various problems of asymmetric information and incomplete contracts that generate a need for\\ud public policy responses to ...

  9. The ventilatory response to hypoxia: how much is good for a mountaineer?

    OpenAIRE

    Milledge, J. S.

    1987-01-01

    Methods for measuring the ventilatory response to hypoxia (HVR) are reviewed. The criteria for success as a high altitude mountaineer are defined as freedom from acute mountain sickness (AMS) and ability to perform well at extreme altitude. The evidence for a brisk HVR being protective against AMS and associated with successful high altitude performance is reviewed. The contrary evidence of blunted HVR in high altitude residence and some elite climbers is discussed. The effect of a brisk HVR ...

  10. Doing good and doing well: corporate social responsibility in post Obamacare America.

    Science.gov (United States)

    Corbett, James; Kappagoda, Manel

    2013-03-01

    This paper looks how health systems can go beyond clinical care to address the social determinants of health and considers why this approach might be particularly relevant for Accountable Care Organizations (ACOs) touted by the Affordable Care Act. ACOs make profits by reducing the medical expenses of patient populations. The leading causes of death in the United States are tobacco use, insufficient physical activity, and an unhealthy diet. These risk factors are linked to increased incidence of a wide range of chronic diseases, the treatment of which places a tremendous financial burden on our health care system. Health care delivery and access are just a small part of the solution to our chronic disease crisis. Increasingly, strategies that address the social determinants of health--"the conditions into which people are born, grow, live, work, and age"-- are the ones that hold the most promise. In Massachusetts, Steward Health Care System supports a number of initiatives to address the social determinants of health in its patient population. Steward provides an example of how a hospital system can address the health of its patient population by moving beyond clinical care. The varied initiatives have also resulted in cost savings for the system. © 2013 American Society of Law, Medicine & Ethics, Inc.

  11. Blocking Avoidance and Escape Responses: Relations With Clinically Relevant Behaviors

    Directory of Open Access Journals (Sweden)

    Juliana Maria Bubna Popovitz

    Full Text Available Abstract: The current study aims to evaluate the possible effects of interrupting problematic clinically relevant behaviors on the percentage of these responses and of clinical improvement-related responses. Two clients were treated with Functional Analytic Psychotherapy (FAP, alternating two conditions (ABAB. On condition A, procedures to the therapist consisted of responding to the clinical improvement responses, and to description of outside of therapeutic setting behaviors, but therapists were advised to ignore problem behaviors emitted in session. During condition B, therapists followed the same procedures, but they were oriented to block (interrupt problematic responses emitted in session. Results suggest increase in the percentage of problem behaviors during condition B. Results are discussed, highlighting the viability of planning the contingent response the therapist emits to clinically relevant behaviors.

  12. Safety Profile of Good Manufacturing Practice Manufactured Interferon γ-Primed Mesenchymal Stem/Stromal Cells for Clinical Trials.

    Science.gov (United States)

    Guess, Adam J; Daneault, Beth; Wang, Rongzhang; Bradbury, Hillary; La Perle, Krista M D; Fitch, James; Hedrick, Sheri L; Hamelberg, Elizabeth; Astbury, Caroline; White, Peter; Overolt, Kathleen; Rangarajan, Hemalatha; Abu-Arja, Rolla; Devine, Steven M; Otsuru, Satoru; Dominici, Massimo; O'Donnell, Lynn; Horwitz, Edwin M

    2017-10-01

    Mesenchymal stem/stromal cells (MSCs) are widely studied by both academia and industry for a broad array of clinical indications. The collective body of data provides compelling evidence of the clinical safety of MSC therapy. However, generally accepted proof of therapeutic efficacy has not yet been reported. In an effort to generate a more effective therapeutic cell product, investigators are focused on modifying MSC processing protocols to enhance the intrinsic biologic activity. Here, we report a Good Manufacturing Practice-compliant two-step MSC manufacturing protocol to generate MSCs or interferon γ (IFNγ) primed MSCs which allows freshly expanded cells to be infused in patients on a predetermined schedule. This protocol eliminates the need to infuse cryopreserved, just thawed cells which may reduce the immune modulatory activity. Moreover, using (IFNγ) as a prototypic cytokine, we demonstrate the feasibility of priming the cells with any biologic agent. We then characterized MSCs and IFNγ primed MSCs prepared with our protocol, by karyotype, in vitro potential for malignant transformation, biodistribution, effect on engraftment of transplanted hematopoietic cells, and in vivo toxicity in immune deficient mice including a complete post-mortem examination. We found no evidence of toxicity attributable to the MSC or IFNγ primed MSCs. Our data suggest that the clinical risk of infusing MSCs or IFNγ primed MSCs produced by our two-step protocol is not greater than MSCs currently in practice. While actual proof of safety requires phase I clinical trials, our data support the use of either cell product in new clinical studies. Stem Cells Translational Medicine 2017;6:1868-1879. © 2017 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

  13. Experiments in interdisciplinarity: Responsible research and innovation and the public good

    Science.gov (United States)

    Åm, Heidrun

    2018-01-01

    In Europe, responsible research and innovation (RRI) has emerged as a science policy measure that demands the early integration of a broad range of social actors and perspectives into research and development (R&D). More collaboration of the social sciences and humanities (SSH) with science and engineering appears within this policy framework as a crucial element that will enable better technological development. However, RRI is new to both natural scientists and SSH scholars, and interdisciplinary collaborations are challenging for many reasons. In this paper, we discuss these challenges while suggesting that what RRI can be in a particular project is not a given but remains an empirical question. Natural scientists and SSH scholars need to coresearch RRI in an experimental mode. PMID:29579043

  14. Experiments in interdisciplinarity: Responsible research and innovation and the public good.

    Science.gov (United States)

    Delgado, Ana; Åm, Heidrun

    2018-03-01

    In Europe, responsible research and innovation (RRI) has emerged as a science policy measure that demands the early integration of a broad range of social actors and perspectives into research and development (R&D). More collaboration of the social sciences and humanities (SSH) with science and engineering appears within this policy framework as a crucial element that will enable better technological development. However, RRI is new to both natural scientists and SSH scholars, and interdisciplinary collaborations are challenging for many reasons. In this paper, we discuss these challenges while suggesting that what RRI can be in a particular project is not a given but remains an empirical question. Natural scientists and SSH scholars need to coresearch RRI in an experimental mode.

  15. [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

    Science.gov (United States)

    Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

    2015-06-01

    Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p research coordination and management" (p clinical practice.

  16. Doing Well or Doing Good: The Relationship between Corporate Social Responsibility and Profit in Romanian Companies

    Directory of Open Access Journals (Sweden)

    Camelia-Daniela Hategan

    2018-04-01

    Full Text Available The traditional goal of a company is to earn profit to pay its shareholders, but, nowadays, for the business to be sustainable in the long term, a strategy of Corporate Social Responsibility (CSR activities is needed to meet stakeholder demands, respect ethical principles and give an appropriate answer to organizational stakeholders. The objective of the paper is to identify how strong the correlation between CSR and profit is, and how companies behave in the periods they have losses, whether they continue to do CSR activities, they reduce the activities, or they give them up. Thus, CSR is attributed to the concept of “doing good” and profit to the expression of “doing well”, from which a “positive business” can be built. Our empirical research consists of a panel data econometric model using logistics regressions to highlight the correlation between profit and the decision to do CSR activities and feasible generalized least squares (FGLS regressions to identify the correlations between the level of CSR activities and the dimension of profit, an expression of financial performance. The main results emphasize that the companies which implement CSR activities in a greater extent are more profitable in economic terms.

  17. [Analysis of good practices for inhabitant participation in the clinical management units of the Andalusian Health Service (Spain)].

    Science.gov (United States)

    Gómez Martínez, M Eugenia; Pastor Moreno, Guadalupe; Pérez Corral, Olivia; Iriarte de Los Santos, M Teresa; Mena Jiménez, Ángel Luis; Escudero Espinosa, M Cecilia; García Romera, Inmaculada; Blanco García, Martín Germán; Martín Barato, Amelia

    To discover good practices for inhabitant participation in the clinical management units (CMUs) of the Andalusian Health Service (AHS) (Spain) and to explore the reasons perceived by CMU and AHS professionals that may influence the presence and distribution of those good practices among the CMU. Study with mixed methodology carried out in Andalusia (Spain) in two phases (2013-2015). Firstly, an online survey was delivered to the Directors of the CMUs which had set up an inhabitant participation commission. In a second phase, a qualitative study was carried out through semi-structured interviews with professionals from the Andalusian Health Service with previous experience in inhabitant participation. A descriptive analysis of the quantitative information and a semantic content analysis of the qualitative information were carried out. 530 CMUs took part in the survey. The inhabitant participation practices more often implemented in the CMUs are those related to the informing and consultation levels. Twelve professionals were interviewed in the second phase. Other practices with higher inhabitant involvement and delegation are secondary. The barriers which were identified by professionals are related to the beliefs and attitudes of the inhabitants, the professionals, the health system and the environment. The main practices for inhabitant participation in the CMUs are related to the most basic levels of participation. The method and dynamics which facilitate inhabitant empowerment within the health system are not clearly recognised. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. Good clinical practice guide for opioids in pain management: the three Ts - titration (trial, tweaking (tailoring, transition (tapering

    Directory of Open Access Journals (Sweden)

    Flaminia Coluzzi

    2016-06-01

    Full Text Available ABSTRACT BACKGROUND AND OBJECTIVES: Achieving good clinical practice in the use of opioids as part of a comprehensive pain management regimen can face significant challenges. Despite guidelines from governmental and pain society/organization sources, there are still significant hurdles. A review of some basic tenets of opioid analgesia based on current published knowledge and experiences about this important healthcare imperative is warranted. CONTENT: Consistent with guidelines, the literature supports using the lowest total opioid dose that provides adequate pain control with the fewest adverse effects. Titration (or trial during opioid initiation is a way of starting low and going slow (and assessing the appropriateness of a specific opioid and formulation. Recognizing that multiple factors contribute to an individual's personal experience of pain, the physical, psychological, social, cultural, spiritual, pharmacogenomic, and behavioral factors of the individual patient should be taken into account (tweaking, or tailoring. Finally, for those patients for whom transition (tapering from opioid is desired, doing so too rapidly can have negative consequences and minimization of problems during this step can be achieved by proper tapering. CONCLUSION: We conclude that a simultaneously aggressive, yet conservative, approach is advocated in the literature in which opioid therapy is divided into three key steps (the 3 T's: titration (or trial, tweaking (or tailoring, and transition (or tapering. Establishment of the 3 T's along with the application of other appropriate good medical practice and clinical experience/judgment, including non-pharmacologic approaches, can assist healthcare providers in the effort to achieve optimal management of pain.

  19. Responsiveness of clinical tests for people with neck pain

    DEFF Research Database (Denmark)

    Jørgensen, René; Ris, Inge; Juhl, Carsten

    2017-01-01

    of four clinical tests which are low cost and easy to perform in a clinical setting, including the craniocervical flexion test, cervical active range of movement, test for the cervical extensors and pressure pain threshold testing. METHODS: This study is a secondary analysis of data collected......BACKGROUND: Responsiveness of a clinical test is highly relevant in order to evaluate the effect of a given intervention. However, the responsiveness of clinical tests for people with neck pain has not been adequately evaluated. The objective of the present study was to examine the responsiveness...... in a previously published randomised controlled trial. Participants were randomized to either physical training, exercises and pain education combined or pain education only. Participants were tested on the clinical tests at baseline and at 4-month follow-up. An anchor-based approach using Receiver Operator...

  20. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

    Science.gov (United States)

    Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

    2014-07-01

    The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

  1. 42 CFR 493.1457 - Standard; Clinical consultant responsibilities.

    Science.gov (United States)

    2010-10-01

    ... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing High Complexity Testing § 493.1457 Standard; Clinical consultant... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

  2. Bad-good constraints on a polarity correspondence account for the spatial-numerical association of response codes (SNARC) and markedness association of response codes (MARC) effects.

    Science.gov (United States)

    Leth-Steensen, Craig; Citta, Richie

    2016-01-01

    Performance in numerical classification tasks involving either parity or magnitude judgements is quicker when small numbers are mapped onto a left-sided response and large numbers onto a right-sided response than for the opposite mapping (i.e., the spatial-numerical association of response codes or SNARC effect). Recent research by Gevers et al. [Gevers, W., Santens, S., Dhooge, E., Chen, Q., Van den Bossche, L., Fias, W., & Verguts, T. (2010). Verbal-spatial and visuospatial coding of number-space interactions. Journal of Experimental Psychology: General, 139, 180-190] suggests that this effect also arises for vocal "left" and "right" responding, indicating that verbal-spatial coding has a role to play in determining it. Another presumably verbal-based, spatial-numerical mapping phenomenon is the linguistic markedness association of response codes (MARC) effect whereby responding in parity tasks is quicker when odd numbers are mapped onto left-sided responses and even numbers onto right-sided responses. A recent account of both the SNARC and MARC effects is based on the polarity correspondence principle [Proctor, R. W., & Cho, Y. S. (2006). Polarity correspondence: A general principle for performance of speeded binary classification tasks. Psychological Bulletin, 132, 416-442]. This account assumes that stimulus and response alternatives are coded along any number of dimensions in terms of - and + polarities with quicker responding when the polarity codes for the stimulus and the response correspond. In the present study, even-odd parity judgements were made using either "left" and "right" or "bad" and "good" vocal responses. Results indicated that a SNARC effect was indeed present for the former type of vocal responding, providing further evidence for the sufficiency of the verbal-spatial coding account for this effect. However, the decided lack of an analogous SNARC-like effect in the results for the latter type of vocal responding provides an important

  3. Relevance of Financial Performance and Good Corporate Governance Determinant of Sustainaibility Corporate Social Responsibility Disclousure in Islamic Bank in Indonesia

    Directory of Open Access Journals (Sweden)

    Fitriyah Fitriyah

    2014-06-01

    Full Text Available The purpose of the paper is to investigate role of the financial performance, ownership structure and number of syari'a supervisory board of Islamic banks in Indonesia on the sustainability of corporate social responsibilities (CSR disclosure. Ownership structure and number of syari'a supervisory board of Islamic banks as proxy of implementation good corporate governance (GCG. There are seven (7 fully fledge Islamic banks in Indonesia. This study uses logic regression to test empirically whether the CSR is highly influenced by the factors identified earlier. Evidence was found that size, ROA and leverage do not have significant role in corporate social responsibilities (CSR disclosure. Specifically, the results infer the fact that the CSR disclosures are significant and positively associated to bank size and ownership structure only. The result of the study has confirms the hypothesis that bank size and ROA has positive associated with CSR disclosure. This suggested that large and profitable banks have more resources to devote to social activities. Leverage negatively influences the disclosure of CSR. Thus, lowly leveraged banks will tend to make larger donations than highly leveraged banks. Ownership structure and number of syari'a supervisory board of Islamic banks have positive associated to CSR disclosure. These results also confirm the predictions that good corporate governance mechanism lead to the greater monitoring and thereby greater CSR disclosure.

  4. Hepatitis B surface antigen titer is a good indicator of durable viral response after entecavir off-treatment for chronic hepatitis B

    Directory of Open Access Journals (Sweden)

    Han Ah Lee

    2016-09-01

    Full Text Available Background/Aims Clear indicators for stopping antiviral therapy in chronic hepatitis B (CHB patients are not yet available. Since the level of hepatitis B surface antigen (HBsAg is correlated with covalently closed circular DNA, the HBsAg titer might be a good indicator of the off-treatment response. This study aimed to determine the relationship between the HBsAg titer and the entecavir (ETV off-treatment response. Methods This study analyzed 44 consecutive CHB patients (age, 44.6±11.4 years, mean±SD; men, 63.6%; positive hepatitis B envelope antigen (HBeAg at baseline, 56.8%; HBV DNA level, 6.8±1.3 log10 IU/mL treated with ETV for a sufficient duration and in whom treatment was discontinued after HBsAg levels were measured. A virological relapse was defined as an increase in serum HBV DNA level of >2000 IU/mL, and a clinical relapse was defined as a virological relapse with a biochemical flare, defined as an increase in the serum alanine aminotransferase level of >2 × upper limit of normal. Results After stopping ETV, virological relapse and clinical relapse were observed in 32 and 24 patients, respectively, during 20.8±19.9 months of follow-up. The cumulative incidence rates of virological relapse were 36.2% and 66.2%, respectively, at 6 and 12 months, and those of clinical relapse were 14.3% and 42.3%. The off-treatment HBsAg level was an independent factor associated with clinical relapse (hazard ratio, 2.251; 95% confidence interval, 1.076–4.706; P=0.031. When patients were grouped according to off-treatment HBsAg levels, clinical relapse did not occur in patients with an off-treatment HBsAg level of ≤2 log10 IU/mL (n=5, while the incidence rates of clinical relapse at 12 months after off-treatment were 28.4% and 55.7% in patients with off-treatment HBsAg levels of >2 and ≤3 log10 IU/mL (n=11 and >3 log10 IU/mL (n=28, respectively. Conclusion The off-treatment HBsAg level is closely related to clinical relapse after treatment

  5. Clinical implications of heterogeneity of tumor response to radiation therapy

    International Nuclear Information System (INIS)

    Suit, H.; Skates, S.; Taghian, A.; Okunieff, P.; Efird, J.T.

    1992-01-01

    Heterogeneity of response of tumor tissue to radiation clearly exists. Major parameters include histopathologic type, size (number of tumor rescue units (TRUs)), hemoglobin concentration, cell proliferation kinetics and immune rejection reaction by host. Further, normal and presumably tumor tissue response is altered in certain genetic diseases, e.g. ataxia telangiectasia. Any assessment of response of tumor tissue to a new treatment method or the testing of a new clinical response predictor is optimally based upon a narrow strata, viz., uniform with respect to known parameters of response, e.g. size, histological type. Even among tumors of such a clinical defined narrow strata, there will be residual heterogeneity with respect to inherent cellular radiation sensitivity, distributions of pO 2 , (SH), cell proliferation, etc. (author). 39 refs., 7 figs., 3 tabs

  6. Perspectives on providing good access to dental services for elderly people: patient selection, dentists' responsibility and budget management.

    Science.gov (United States)

    Grytten, Jostein; Holst, Dorthe

    2013-06-01

    To suggest a model for organizing and financing dental services for elderly people so that they have good access to services. There are few studies on how dental services for elderly people should be organized and financed. This is surprising if we take into consideration the fact that the proportion of elderly people is growing faster than any other group in the population, and that elderly people have more dental diseases and poorer access to dental services than the rest of the adult population. In several countries, dental services are characterized by private providers who often operate in a market with competition and free price-setting. Private dentists have no community responsibility, and they are free to choose which patients they treat. Literature review and critical reasoning. In order to avoid patient selection, a patient list system for elderly people is recommended, with per capita remuneration for the patients that the dentist is given responsibility for. The patient list system means that the dentist assumes responsibility for a well-defined list of elderly people. Our model will lead to greater security in the dentist/patient relationship, and patients with great treatment needs will be ensured access to dental services. © 2012 John Wiley & Sons A/S and The Gerodontology Society. Published by John Wiley & Sons Ltd.

  7. Partial clinical response to anakinra in severe palmoplantar pustular psoriasis.

    Science.gov (United States)

    Tauber, M; Viguier, M; Alimova, E; Petit, A; Lioté, F; Smahi, A; Bachelez, H

    2014-09-01

    Palmoplantar pustular psoriasis is a clinical psoriasis variant characterised by a high impact on quality of life and poor response to biologics approved for plaque type psoriasis.The recombinant interleukin-1 (IL-1) receptor antagonist anakinra has been recently used for the treatment of isolated refractory cases of generalised pustular psoriasis with contrasted results. To report the clinical response in two patients treated with anakinra as salvage therapy in two patients with severe palmoplantar pustular psoriasis refractory to currently available antipsoriatic systemic therapies. Anakinra was given subcutaneously at the daily dose of 100 mg, and clinical response was evaluated using the palmoplantar psoriasis area and severity index (PPPASI). Only partial and transient responses were observed in both patients, who had to stop anakinra due to lack of efficacy and to side effects. Anakinra appears to provide only partial clinical improvement in refractory palmoplantar pustular psoriasis. Prospective clinical studies on larger populations are warranted to investigate more accurately both efficacy and safety of IL-1-inhibiting strategies in pustular psoriasis. © 2014 British Association of Dermatologists.

  8. "Good mothering" or "good citizenship"?

    Science.gov (United States)

    Porter, Maree; Kerridge, Ian H; Jordens, Christopher F C

    2012-03-01

    Umbilical cord blood banking is one of many biomedical innovations that confront pregnant women with new choices about what they should do to secure their own and their child's best interests. Many mothers can now choose to donate their baby's umbilical cord blood (UCB) to a public cord blood bank or pay to store it in a private cord blood bank. Donation to a public bank is widely regarded as an altruistic act of civic responsibility. Paying to store UCB may be regarded as a "unique opportunity" to provide "insurance" for the child's future. This paper reports findings from a survey of Australian women that investigated the decision to either donate or store UCB. We conclude that mothers are faced with competing discourses that force them to choose between being a "good mother" and fulfilling their role as a "good citizen." We discuss this finding with reference to the concept of value pluralism.

  9. Prognostic factors of a good response to initial therapy in children and adolescents with differentiated thyroid cancer

    Directory of Open Access Journals (Sweden)

    Fernanda Vaisman

    2011-01-01

    Full Text Available BACKGROUND: Therapeutic approaches in pediatric populations are based on adult data because there is a lack of appropriate data for children. Consequently, there are many controversies regarding the proper treatment of pediatric patients. OBJECTIVE: The present study was designed to evaluate patients with differentiated thyroid carcinoma diagnosed before 20 years of age and to determine the factors associated with the response to the initial therapy. METHODS: Sixty-five patients, treated in two tertiary-care referral centers in Rio de Janeiro between 1980 and 2005 were evaluated. Information about clinical presentation and the response to initial treatment was analyzed and patients had their risk stratified in Tumor-Node- Metastasis; Age-Metastasis-Extracapsular-Size; distant Metastasis-Age-Completeness of primary tumor resection-local Invasion-Size and American-Thyroid-Association classification RESULTS: Patients ages ranged from 4 to 20 years (median 14. The mean follow-up was 12,6 years. Lymph node metastasis was found in 61.5% and indicated a poor response to initial therapy, with a significant impact on time for achieving disease free status (p = 0.014 for response to initial therapy and p<0,0001 for disease-free status in follow-up. Distant metastasis was a predictor of a poor response to initial therapy in these patients (p = 0.014. The risk stratification systems we analyzed were useful for high-risk patients because they had a high sensitivity and negative predictive value in determining the response to initial therapy. CONCLUSIONS: Metastases, both lymph nodal and distant, are important predictors of the persistence of disease after initial therapy in children and adolescents with differentiated thyroid cancer.

  10. Physicians’ Professionally Responsible Power: A Core Concept of Clinical Ethics

    Science.gov (United States)

    McCullough, Laurence B.

    2016-01-01

    The gathering of power unto themselves by physicians, a process supported by evidence-based practice, clinical guidelines, licensure, organizational culture, and other social factors, makes the ethics of power—the legitimation of physicians’ power—a core concept of clinical ethics. In the absence of legitimation, the physician’s power over patients becomes problematic, even predatory. As has occurred in previous issues of the Journal, the papers in the 2016 clinical ethics issue bear on the professionally responsible deployment of power by physicians. This introduction explores themes of physicians’ power in papers from an international group of authors who address autonomy and trust, the virtues of perinatal hospice, conjoined twins in ethics and law, addiction and autonomy in clinical research on addicting substances, euthanasia of patients with dementia in Belgium, and a pragmatic approach to clinical futility. PMID:26671961

  11. Does a family history of RA influence the clinical presentation and treatment response in RA?

    Science.gov (United States)

    Frisell, Thomas; Saevarsdottir, Saedis; Askling, Johan

    2016-06-01

    To assess whether family history of rheumatoid arthritis (RA), among the strongest risk factors for developing RA, also carries information on the clinical presentation and treatment response. The prospective Swedish Rheumatology register was linked to family history of RA, defined as diagnosed RA in any first-degree relative, ascertained through the Swedish Multi-Generation and Patient registers. Clinical presentation was examined among patients with early RA 2000-2011 (symptom onset clinical characteristics, drug survival, European League Against Rheumatism (EULAR) response and change in disease activity at 3 and 6 months was estimated using linear and generalised logistic regression models. Correlation in relatives' response measures was also assessed. Patients with early RA with family history of RA were more often rheumatoid factor positive, but with no other clinically meaningful differences in their clinical presentation. Family history of RA did not predict response to MTX or TNFi, with the possible exception of no versus good EULAR response to TNFi at 6 months (OR=1.4, 95% CI 1.1 to 1.7). Having a relative who discontinued TNFi within a year increased the odds of doing the same (OR=3.7, 95% CI 1.8 to 7.5), although we found no significant familial correlations in change in disease activity measures. Family history of RA did not modify the clinical presentation of RA or predict response to standard treatment with MTX or TNFi. Treatment response, particularly drug survival, may itself be familial. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  12. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    Science.gov (United States)

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  13. Childhood asthma clusters and response to therapy in clinical trials.

    Science.gov (United States)

    Chang, Timothy S; Lemanske, Robert F; Mauger, David T; Fitzpatrick, Anne M; Sorkness, Christine A; Szefler, Stanley J; Gangnon, Ronald E; Page, C David; Jackson, Daniel J

    2014-02-01

    Childhood asthma clusters, or subclasses, have been developed by computational methods without evaluation of clinical utility. To replicate and determine whether childhood asthma clusters previously identified computationally in the Severe Asthma Research Program (SARP) are associated with treatment responses in Childhood Asthma Research and Education (CARE) Network clinical trials. A cluster assignment model was determined by using SARP participant data. A total of 611 participants 6 to 18 years old from 3 CARE trials were assigned to SARP pediatric clusters. Primary and secondary outcomes were analyzed by cluster in each trial. CARE participants were assigned to SARP clusters with high accuracy. Baseline characteristics were similar between SARP and CARE children of the same cluster. Treatment response in CARE trials was generally similar across clusters. However, with the caveat of a smaller sample size, children in the early-onset/severe-lung function cluster had best response with fluticasone/salmeterol (64% vs 23% 2.5× fluticasone and 13% fluticasone/montelukast in the Best ADd-on Therapy Giving Effective Responses trial; P = .011) and children in the early-onset/comorbidity cluster had the least clinical efficacy to treatments (eg, -0.076% change in FEV1 in the Characterizing Response to Leukotriene Receptor Antagonist and Inhaled Corticosteroid trial). In this study, we replicated SARP pediatric asthma clusters by using a separate, large clinical trials network. Early-onset/severe-lung function and early-onset/comorbidity clusters were associated with differential and limited response to therapy, respectively. Further prospective study of therapeutic response by cluster could provide new insights into childhood asthma treatment. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  14. Selection of response criteria for clinical trials of sarcoma treatment.

    Science.gov (United States)

    Schuetze, Scott M; Baker, Laurence H; Benjamin, Robert S; Canetta, Renzo

    2008-01-01

    Soft tissue sarcomas are a heterogeneous group of malignancies arising from mesenchymal tissues. A large number of new therapies are being evaluated in patients with sarcomas, and consensus criteria defining treatment responses are essential for comparison of results from studies completed by different research groups. The 1979 World Health Organization (WHO) handbook set forth operationally defined criteria for response evaluation in solid tumors that were updated in 2000 with the publication of the Response Evaluation Criteria in Solid Tumors (RECIST). There have been significant advances in tumor imaging, however, that are not reflected in the RECIST. For example, computed tomography (CT) slice thickness has been reduced from 10 mm to < or =2.5 mm, allowing for more reproducible and accurate measurement of smaller lesions. Combination of imaging techniques, such as positron emission tomography with fluorine-18-fluorodeoxyglucose (18FDG-PET) and CT can provide investigators and clinicians with both anatomical and functional information regarding tumors, and there is now a large body of evidence demonstrating the effectiveness of PET/CT and other newer imaging methods for the detection and staging of tumors as well as early determination of responses to therapy. The application of newer imaging methods has the potential to decrease both the sample sizes required for, and duration of, clinical trials by providing an early indication of therapeutic response that is well correlated with clinical outcomes, such as time to tumor progression or overall survival. The results summarized in this review support the conclusion that the RECIST and the WHO criteria for evaluation of response in solid tumors need to be modernized. In addition, there is a current need for prospective trials to compare new response criteria with established endpoints and to validate imaging-based response rates as surrogate endpoints for clinical trials of new agents for sarcoma and other solid

  15. Admission Privileges and Clinical Responsibilities for Interventional Radiologists

    Energy Technology Data Exchange (ETDEWEB)

    Al-Kutoubi, Aghiad, E-mail: mk00@aub.edu.lb [The American University of Beirut Medical Center, IR Division, The Department of Diagnostic Radiology (Lebanon)

    2015-04-15

    Although clinical involvement by interventional radiologists in the care of their patients was advocated at the inception of the specialty, the change into the clinical paradigm has been slow and patchy for reasons related to pattern of practice, financial remuneration or absence of training. The case for the value of clinical responsibilities has been made in a number of publications and the consequences of not doing so have been manifest in the erosion of the role of the interventional radiologists particularly in the fields of peripheral vascular and neuro intervention. With the recent recognition of interventional radiology (IR) as a primary specialty in the USA and the formation of IR division in the Union of European Medical Specialists and subsequent recognition of the subspecialty in many European countries, it is appropriate to relook at the issue and emphasize the need for measures to promote the clinical role of the interventional radiologist.

  16. Admission Privileges and Clinical Responsibilities for Interventional Radiologists

    International Nuclear Information System (INIS)

    Al-Kutoubi, Aghiad

    2015-01-01

    Although clinical involvement by interventional radiologists in the care of their patients was advocated at the inception of the specialty, the change into the clinical paradigm has been slow and patchy for reasons related to pattern of practice, financial remuneration or absence of training. The case for the value of clinical responsibilities has been made in a number of publications and the consequences of not doing so have been manifest in the erosion of the role of the interventional radiologists particularly in the fields of peripheral vascular and neuro intervention. With the recent recognition of interventional radiology (IR) as a primary specialty in the USA and the formation of IR division in the Union of European Medical Specialists and subsequent recognition of the subspecialty in many European countries, it is appropriate to relook at the issue and emphasize the need for measures to promote the clinical role of the interventional radiologist

  17. Information needs for the rapid response team electronic clinical tool.

    Science.gov (United States)

    Barwise, Amelia; Caples, Sean; Jensen, Jeffrey; Pickering, Brian; Herasevich, Vitaly

    2017-10-02

    Information overload in healthcare is dangerous. It can lead to critical errors and delays. During Rapid Response Team (RRT) activations providers must make decisions quickly to rescue patients from physiological deterioration. In order to understand the clinical data required and how best to present that information in electronic systems we aimed to better assess the data needs of providers on the RRT when they respond to an event. A web based survey to evaluate clinical data requirements was created and distributed to all RRT providers at our institution. Participants were asked to rate the importance of each data item in guiding clinical decisions during a RRT event response. There were 96 surveys completed (24.5% response rate) with fairly even distribution throughout all clinical roles on the RRT. Physiological data including heart rate, respiratory rate, and blood pressure were ranked by more than 80% of responders as being critical information. Resuscitation status was also considered critically useful by more than 85% of providers. There is a limited dataset that is considered important during an RRT. The data is widely available in EMR. The findings from this study could be used to improve user-centered EMR interfaces.

  18. Ewing's sarcoma: only patients with 100% of necrosis after chemotherapy should be classified as having a good response.

    Science.gov (United States)

    Albergo, J I; Gaston, C L; Laitinen, M; Darbyshire, A; Jeys, L M; Sumathi, V; Parry, M; Peake, D; Carter, S R; Tillman, R; Abudu, A T; Grimer, R J

    2016-08-01

    The purpose of this study was to review a large cohort of patients and further assess the correlation between the histological response to chemotherapy in patients with Ewing's sarcoma with the overall (OS) and event-free survival (EFS). All patients treated for Ewing's sarcoma between 1980 and 2012 were reviewed. Of these, 293 patients without metastases at the time of diagnosis and treated with chemotherapy and surgery were included. Patients were grouped according to the percentage of necrosis after chemotherapy: Group I: 0% to 50%, Group II: 51% to 99% and Group III: 100%. The mean age at diagnosis was 16 years (1 to 62) and the mean follow-up was 9.1 years (six months to 32.6 years). The OS and EFS for the series were 75% and 65% at five years. There were significant differences in survival between the groups of necrosis: 0% to 50% (OS: 49% and EFS: 45% at five years, respectively) compared with 51% to 99% (OS: 72% and EFS: 59% at five years, respectively) and 100% (OS: 94% and EFS: 81% at five years, respectively) (p < 0.001). There were no significant differences in survival between patients treated between 1980 and 1989 compared with those treated between 1990 and 1999, and those treated between 2000 and 2012 (p = 0.55). Only patients with 100% necrosis after chemotherapy should be classified as having a good response to chemotherapy because they have significantly better rates of survival compared with those with any viable tumour in the surgical specimen. Cite this article: Bone Joint J 2016;98-B:1138-44. ©2016 The British Editorial Society of Bone & Joint Surgery.

  19. [Clinical features and therapeutic response of our anti-SRP positive patients with myositis].

    Science.gov (United States)

    Botos, Balázs; Nagy-Vincze, Melinda; Dankó, Katalin

    2017-09-01

    Idiopathic inflammatory myopathies are a group of clinically heterogeneous diseases, which have been classified by myositis specific antibodies recently. The anti-SRP positive subset of this group is characterized by more severe clinical prognosis than other myositis specific antibody positive types. Our goal was to compare 16 anti-SRP positive patients in the Division of Clinical Immunology, Department of Internal Medicine, University of Debrecen with 16 antibody negative ones. Muscle strength validated in both groups by the manual muscle test proved to be significantly decreased both before and after therapy (χ 2 = 0.006 and 0.019) in the anti-SRP positive group. Muscle-specific inflammatory laboratory parameters showed significant difference only in case of LDH-levels after therapy. Both groups showed good clinical response to first line steroid treatment, yet the significantly higher rate of second line administration suggests worse therapeutic response of the antibody positive group. Based on these facts we determined poor clinical prognosis and therapeutic response of the anti-SRP positive group. Orv Hetil. 2017; 158(35): 1382-1389.

  20. Clinical correlates of sustained response to individual drugs used in naturalistic treatment of patients with bipolar disorder

    NARCIS (Netherlands)

    Post, Robert M.; Leverich, Gabriele S.; Kupka, Ralph; Keck, Paul E.; McElroy, Susan L.; Altshuler, Lori L.; Frye, Mark A.; Rowe, Michael; Grunze, Heinz; Suppes, Trisha; Nolen, Willem A.

    Objective: To report use and treatment success rates of medications for bipolar disorder as a function of patients' clinical characteristics. Method: Outpatients with bipolar illness diagnosed by SCID were rated by research assistants on the NIMH-LCM and those who had an good response for at least 6

  1. Clinical utility of pretreatment prediction of chemoradiotherapy response in rectal cancer: a review.

    Science.gov (United States)

    Yoo, Byong Chul; Yeo, Seung-Gu

    2017-03-01

    Approximately 20% of all patients with locally advanced rectal cancer experience pathologically complete responses following neoadjuvant chemoradiotherapy (CRT) and standard surgery. The utility of radical surgery for patients exhibiting good CRT responses has been challenged. Organ-sparing strategies for selected patients exhibiting complete clinical responses include local excision or no immediate surgery. The subjects of this tailored management are patients whose presenting disease corresponds to current indications of neoadjuvant CRT, and their post-CRT tumor response is assessed by clinical and radiological examinations. However, a model predictive of the CRT response, applied before any treatment commenced, would be valuable to facilitate such a personalized approach. This would increase organ preservation, particularly in patients for whom upfront CRT is not generally prescribed. Molecular biomarkers hold the greatest promise for development of a pretreatment predictive model of CRT response. A combination of clinicopathological, radiological, and molecular markers will be necessary to render the model robust. Molecular research will also contribute to the development of drugs that can overcome the radioresistance of rectal tumors. Current treatments for rectal cancer are based on the expected prognosis given the presenting disease extent. In the future, treatment schemes may be modified by including the predicted CRT response evaluated at presentation.

  2. Immunologic and clinical responses to "Monday morning miseries" antigens.

    Science.gov (United States)

    Cernelc, S; Stropnik, Z

    1987-01-01

    Authors analysed 96 workers exposed to air conditioning system (Group A), and 71 workers (Group B) breathing normal ambient air. 38 workers in group A had a positive clinical history of "Monday morning miseries". Eight cases with the diagnosis hypersensitivity pneumonitis, acute and chronic form was based on environmental history, clinical investigations, physical examination, Chest-X-ray examination, immunological test "in vivo" and "in vitro" with common allergens and antigen "Monday morning miseries", ELISA, spirometry and PEFR (Peak Expiratory Flow-Rate) measurements. Exposure to contaminated air may be responsible for morbidity and reduced performance of workers.

  3. What good are positive emotions for treatment? Trait positive emotionality predicts response to Cognitive Behavioral Therapy for anxiety.

    Science.gov (United States)

    Taylor, Charles T; Knapp, Sarah E; Bomyea, Jessica A; Ramsawh, Holly J; Paulus, Martin P; Stein, Murray B

    2017-06-01

    Cognitive behavioral therapy (CBT) is empirically supported for the treatment of anxiety disorders; however, not all individuals achieve recovery following CBT. Positive emotions serve a number of functions that theoretically should facilitate response to CBT - they promote flexible patterns of information processing and assimilation of new information, encourage approach-oriented behavior, and speed physiological recovery from negative emotions. We conducted a secondary analysis of an existing clinical trial dataset to test the a priori hypothesis that individual differences in trait positive emotions would predict CBT response for anxiety. Participants meeting diagnostic criteria for panic disorder (n = 28) or generalized anxiety disorder (n = 31) completed 10 weekly individual CBT sessions. Trait positive emotionality was assessed at pre-treatment, and severity of anxiety symptoms and associated impairment was assessed throughout treatment. Participants who reported a greater propensity to experience positive emotions at pre-treatment displayed the largest reduction in anxiety symptoms as well as fewer symptoms following treatment. Positive emotions remained a robust predictor of change in symptoms when controlling for baseline depression severity. Initial evidence supports the predictive value of trait positive emotions as a prognostic indicator for CBT outcome in a GAD and PD sample. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Hypertensive response to exercise: mechanisms and clinical implication

    OpenAIRE

    Kim, Darae; Ha, Jong-Won

    2016-01-01

    A hypertensive response to exercise (HRE) is frequently observed in individuals without hypertension or other cardiovascular disease. However, mechanisms and clinical implication of HRE is not fully elucidated. Endothelial dysfunction and increased stiffness of large artery contribute to development of HRE. From neurohormonal aspects, excess stimulation of sympathetic nervous system and augmented rise of angiotensin II seems to be important mechanism in HRE. Increasing evidences indicates tha...

  5. CT in normal pressure hydrocephalus. Correlation between CT and clinical response to shunting

    Energy Technology Data Exchange (ETDEWEB)

    Fujita, K.; Nogaki, H.; Noda, M.; Kusunoki, T.; Tamaki, N. (Kobe Univ. (Japan). School of Medicine)

    1981-02-01

    CT scans were obtained on 33 patients (age 73y. to 31y.) with the diagnosis of normal pressure hydrocephalus. In each case, the diagnosis was made on the basis of the symptoms, CT and cisternographic findings. Underlying diseases of normal pressure hydrocephalus are ruptured aneurysms (21 cases), arteriovenous malformations (2 cases), head trauma (1 case), cerebrovascular accidents (1 case) and idiopathie (8 cases). Sixteen of 33 patients showed marked improvement, five, moderate or minimal improvement, and twelve, no change. The results were compared with CT findings and clinical response to shunting. CT findings were classified into five types, bases on the degree of periventricular hypodensity (P.V.H.), the extent of brain damage by underlying diseases, and the degree of cortical atrophy. In 17 cases of type (I), CT shows the presence of P.V.H. with or without minimal frontal lobe damage and no cortical atrophy. The good surgical improvements were achieved in all cases of type (I) by shunting. In 4 cases of type (II), CT shows the presence of P.V.H. and severe brain damage without cortical atrophy. The fair clinical improvements were achieved in 2 cases (50%) by shunting. In one case of type (III), CT shows the absence of P.V.H. without brain damage nor cortical atrophy. No clinical improvement was obtained by shunting in this type. In 9 cases of type (IV) with mild cortical atrophy, the fair clinical improvement was achieved in two cases (22%) and no improvement in 7 cases. In 2 cases of type (V) with moderate or marked cortical atrophy, no clinical improvement was obtained by shunting. In conclusion, it appeared from the present study that there was a good correlation between the result of shunting and the type of CT, and clinical response to shunting operation might be predicted by classification of CT findings.

  6. Knowledge, compliance with good clinical practices and barriers to effective control of postoperative pain among nurses from hospitals with and without a "Hospital without Pain" certificate.

    Science.gov (United States)

    Tomaszek, Lucyna; Dębska, Grażyna

    2018-04-01

    (i) To compare knowledge and compliance with good clinical practices regarding control of postoperative pain among nurses employed at hospitals with and without a "Hospital without Pain" certificate, (ii) to identify the determinants of nurses' knowledge and (iii) to define barriers to effective control of postoperative pain. Only a slight improvement in postoperative pain control has been observed recently, if any. Implementation of good clinical practices in the control of postoperative pain requires involvement of nurses. A cross-sectional study. The study included 257 nurses from hospitals with a "Hospital without Pain" certificate and 243 nurses from noncertified hospitals, with mean job seniority of 17.6 ± 9.6 years. All respondents answered 26 questions regarding postoperative pain control-related issues. Based on the answers, overall scores were calculated for (i) nurses' knowledge, (ii) compliance with good clinical practices and (iii) barriers to effective control of postoperative pain. Nurses from the certified hospitals presented with significantly higher levels of knowledge and compliance with good clinical practices and identified significantly more barriers to effective control of postoperative pain. Apart from certification of a hospital, better knowledge of postoperative pain control was determined by higher education, participation in postgraduate training programmes and other relevant courses, self-education from medical journals, employment at paediatric ward or intensive care unit. The most commonly reported barriers to effective control of pain included too low doses of painkillers prescribed by physicians and inability to modify the protocol of pain treatment by the nurse. Control of postoperative pain can be improved by enrolling nurses in various forms of continuous training and by providing them with greater autonomy in administering painkillers to surgical patients. Better quality of care offered to patients with postoperative pain

  7. The inverse relation between psychopathy and faking good: Not response bias but true variance in psychopathic personality

    NARCIS (Netherlands)

    Verschuere, B.; Uzieblo, K.; De Schryver, M.; Douma, H.; Onraedt, T.; Crombez, G.

    2014-01-01

    The possibility to assess psychopathy through self-report is debated, amongst others, because psychopathic individuals may deliberately underreport psychopathic features (fake good). Meta-analytic research has shown an inverse relation between faking good and self-reported psychopathy, possibly

  8. Nuclear Safety: Our Overriding Priority. EDF Group Report 2015 in response to FTSE4Good Nuclear Criteria

    International Nuclear Information System (INIS)

    Maillart, H.

    2015-01-01

    EDF is the world's leading nuclear operator with 74.8 GW of installed capacity in France, the United Kingdom and the United States, an EPR under construction in France, and 2 EPRs under construction in China through TNPJVC (EDF 30%), a joint venture with CGNPC. As such, EDF acts at all stages in the life of its power plants (design, construction, operation, decommissioning) to: - ensure rigorous operation of facilities; - prevent all incidents and accidents; - reduce the impact of any incidents or accidents that might nevertheless occur. The main safety measures were published in a single document in 2015 setting out the Group's nuclear safety policy. Each nuclear operating company inside the Group acts in compliance with the legal obligations and regulations specific to its host country. Each company works to ensure and continuously improve its safety performance with its own methods, skills and values. The EDF Group respects national differences. At the same time it frames common principles to deliver the highest level of incident prevention and protection of the public, workers and the environment. This policy applies to new projects (overall architecture, design and construction) and all existing plants (operation, maintenance, waste management, decommissioning and engineering). The Group works closely with its industrial partners to deliver these objectives. Each company is responsible for the proper operation of its nuclear activities, and delegates responsibilities appropriately to each level of management or operation. The Group guarantees the allocation of resources needed to ensure nuclear safety. An in-house independent nuclear safety function is in place at power plant level, company level and Group level. Each has a duty to alert senior management of inappropriate or inadequate line management response. Nuclear safety is the absolute priority for the EDF Group at every stage of the plant life-cycle. Each company is responsible for ensuring that its

  9. Physicians' Professionally Responsible Power: A Core Concept of Clinical Ethics.

    Science.gov (United States)

    McCullough, Laurence B

    2016-02-01

    The gathering of power unto themselves by physicians, a process supported by evidence-based practice, clinical guidelines, licensure, organizational culture, and other social factors, makes the ethics of power--the legitimation of physicians' power--a core concept of clinical ethics. In the absence of legitimation, the physician's power over patients becomes problematic, even predatory. As has occurred in previous issues of the Journal, the papers in the 2016 clinical ethics issue bear on the professionally responsible deployment of power by physicians. This introduction explores themes of physicians' power in papers from an international group of authors who address autonomy and trust, the virtues of perinatal hospice, conjoined twins in ethics and law, addiction and autonomy in clinical research on addicting substances, euthanasia of patients with dementia in Belgium, and a pragmatic approach to clinical futility. © The Author 2015. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  10. Genetic and clinical predictors of ovarian response in assisted reproductive technology

    Science.gov (United States)

    Wiweko, B.; Damayanti, I.; Suryandari, D.; Natadisastra, M.; Pratama, G.; Sumapraja, K.; Meutia, K.; Iffanolia, P.; Harzief, A. K.; Hestiantoro, A.

    2017-08-01

    Several factors are known to influence ovarian response to rFSH stimulation such as age, antral follicle count (AFC), and basal FSH level, Mutation of allele Ser680Asn in FSHR gene was responsible to ovarian resistance toward exogenous FSH. The aim of this study is to develop a prediction model of ovarian response to COS in IVF. This study was a prospective cohort study. One hundred and thirteen women undergoing their first cycle of IVF in Yasmin IVF Clinic Jakarta were recruited to this study. Clinical datas included were age, BMI, and AFC. Basal FSH and E2 as well as serum AMH was measured from peripheral blood taken at second day of cycle. Bsr-1 enzyme is used to identify the polymorphism in exon 10 position 680 with RFLP technique. Three genotype polymorphism, Asn/Asn (255 bp ribbon), Asn/Ser (97 bp and 158 bp), and Ser/Ser (97 bp, 158 bp, and 255 bp). AFC has the highest predictor for ovarian response with AUC 0.922 (CI 95% 0.833-1.000). AMH also showed high predicting value (AUC 0.843 CI 95% 0.663-1.000). The multivariate analysis revealed combination of AFC, AMH, age, and basal FSH is a good model for ovarian response prediction (AUC=0.97). No significant relation between Asn/Asn, Asn/Ser, or Ser/Ser genotype FSHR polymorphism with ovarian response (p = 0.866) and total dose of rRSH (p = 0.08). This study showed that model combination of AFC, AMH, patient’s age and basal FSH are very good to predict number of mature oocytes.

  11. Basophil responsiveness and clinical picture of acetylsalicylic acid intolerance.

    Science.gov (United States)

    Korosec, Peter; Mavsar, Nusa; Bajrovic, Nissera; Silar, Mira; Mrhar, Ales; Kosnik, Mitja

    2011-01-01

    Exposure to acetylsalicylic acid (ASA) may exacerbate respiratory or skin diseases or induce anaphylactoid reactions in apparently healthy individuals. We wanted to evaluate specific responsiveness of basophils to ASA in correlation with the clinical picture. We performed a prospective single-blind study of 59 subjects involved in clinical evaluation and/or ASA provocation testing. Whole blood basophils were stained with anti-CD63/CD123/HLA-DR mAbs after stimulation with 0.25 or 1 mg/ml ASA. We found that 40 subjects were ASA tolerant and 19 were ASA intolerant. Both groups had comparable manifestations of asthma and/or rhinitis (13 in the tolerant and 9 in the intolerant group). Intolerant subjects showed significantly higher basophil responsiveness to ASA in comparison to tolerant subjects, which was concentration-dependent in both groups. The ratio between responses at 1 mg/ml of ASA and at baseline (activation index) was analyzed according to the clinical picture. We demonstrate that the activation index was higher only in the intolerant subjects with anaphylactoid reactions, but not in a subgroup of subjects with asthma/rhinitis. The ROC calculations show that the optimal threshold activation index was more than 2.18. The sensitivity was 80% and the specificity was 83% in the subgroup with anaphylactoid reactions. In the asthma/rhinitis subgroup, the sensitivity was 78% and the specificity was 50%. Our study demonstrates that there is a significantly higher in vitro basophil response to ASA in intolerant as compared to tolerant subjects. ROC analyses suggest that this measurement might only have a diagnostic value in subjects without asthma and/or rhinitis. Copyright © 2011 S. Karger AG, Basel.

  12. Prevalence and likelihood ratio of symptoms in patients with good therapeutic response to Lycopodium clavatum. A retrospective study.

    Science.gov (United States)

    Eizayaga, José Enrique; Pozzi, María Isabel; Canan, María Clara; Saravia, Laura

    2016-02-01

    Assessment of the likelihood ratio (LR) of symptoms has been proposed as a rational means for detecting indicators to homeopathic medicines. To investigate the prevalence and LR of symptoms commonly attributed to the homeopathic medicine Lycopodium clavatum (Lyc). Secondarily, to answer the question if experienced homeopaths could intuitively infer which the main symptoms of this medicine are. The presence of 35 selected symptoms, prescribed medicines and therapeutic response were assessed retrospectively. The symptoms' prevalence in the Lyc responding population and the LR of the symptoms compared to their prevalence in the remainder of the population were calculated. Two hundred and two Lyc and 550 non Lyc cases (total 752) were included for analysis. Twenty-two symptoms were confirmed as pertaining to Lyc's semiology (prevalence %; LR): contemptuous (3.3; 6.7), urinary stones history (2.7; 5.4), egotism (5.6; 3.6), dictatorial (33.3; 3.4), haughty (8.7; 3.3), sleeps on abdomen (3.3; 3.3), intolerance to clothing in abdomen (12.0; 3.1), reproaches (4.0; 3.0), helplessness (24.0; 2.7), fear of failure (10.7; 2.6), irritability on waking in the morning (16.7; 2.5), constipation alternating with diarrhea (8.7; 2.5), intolerant to contradiction (59.3; 2.3), want of self confidence (30.0; 2.4), abdominal distension after eating (23.3; 2.1); ailments from anticipation (32.0; 1.9), irritability before menses (23.3; 1.8), conscientious (26.0; 1.6), desire of sweets (52.0; 1.6), desire of chocolate (16.7; 1.6), lack of vital heat (41.3; 1.3), and flatterer (1.3; ∞). Surveyed homeopaths' intuitive inferences correlated well with symptoms' prevalence but not with their LR. Lycopodium's main symptoms are well known by homeopaths, but their knowledge correlates well with the symptoms' prevalence and not with their LR. Retrospective assessment of prevalence and LR of symptoms in good responders might be a means for better selection of symptoms for prospective studies

  13. Good leadership for good quality

    OpenAIRE

    Franzon, Vilma Maria

    2016-01-01

    Good leadership is important if you like to have high quality in the results. My experience in the production of the television industry is that conditions for good leadership is insufficient. Therefore, I have tried to get answers for those two questions in my exam report: What are the characteristics of good leadership? What are the prerequisites for good leadership out of production? The method I used is a literature study and observation. I have read a number of books and research studies...

  14. Interactive Voice/Web Response System in clinical research.

    Science.gov (United States)

    Ruikar, Vrishabhsagar

    2016-01-01

    Emerging technologies in computer and telecommunication industry has eased the access to computer through telephone. An Interactive Voice/Web Response System (IxRS) is one of the user friendly systems for end users, with complex and tailored programs at its backend. The backend programs are specially tailored for easy understanding of users. Clinical research industry has experienced revolution in methodologies of data capture with time. Different systems have evolved toward emerging modern technologies and tools in couple of decades from past, for example, Electronic Data Capture, IxRS, electronic patient reported outcomes, etc.

  15. Clinical Trial Data as Public Goods: Fair Trade and the Virtual Knowledge Bank as a Solution to the Free Rider Problem - A Framework for the Promotion of Innovation by Facilitation of Clinical Trial Data Sharing among Biopharmaceutical Companies in the Era of Omics and Big Data.

    Science.gov (United States)

    Evangelatos, Nikolaos; Reumann, Matthias; Lehrach, Hans; Brand, Angela

    2016-01-01

    Knowledge in the era of Omics and Big Data has been increasingly conceptualized as a public good. Sharing of de-identified patient data has been advocated as a means to increase confidence and public trust in the results of clinical trials. On the other hand, research has shown that the current research and development model of the biopharmaceutical industry has reached its innovation capacity. In response to that, the biopharmaceutical industry has adopted open innovation practices, with sharing of clinical trial data being among the most interesting ones. However, due to the free rider problem, clinical trial data sharing among biopharmaceutical companies could undermine their innovativeness. Based on the theory of public goods, we have developed a commons arrangement and devised a model, which enables secure and fair clinical trial data sharing over a Virtual Knowledge Bank based on a web platform. Our model uses data as a virtual currency and treats knowledge as a club good. Fair sharing of clinical trial data over the Virtual Knowledge Bank has positive effects on the innovation capacity of the biopharmaceutical industry without compromising the intellectual rights, proprietary interests and competitiveness of the latter. The Virtual Knowledge Bank is a sustainable and self-expanding model for secure and fair clinical trial data sharing that allows for sharing of clinical trial data, while at the same time it increases the innovation capacity of the biopharmaceutical industry. © 2016 S. Karger AG, Basel.

  16. Impact of genetic polymorphisms on clinical response to antithrombotics

    Directory of Open Access Journals (Sweden)

    Kena J Lanham

    2010-06-01

    Full Text Available Kena J Lanham1,2, Julie H Oestreich3, Steven P Dunn1,2, Steven R Steinhubl41Pharmacy Services, UK HealthCare, University of Kentucky, Lexington, Kentucky, USA; 2Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA; 3Department of Pharmacy Practice, College of Pharmacy, University of Nebraska, Omaha, Nebraska, USA; 4The Medicines Company, Zurich, Switzerland and The Geisinger Clinic, Danville, Pennsylvania, USAAbstract: Antithrombotic therapy, including anticoagulants as well as antiplatelet drugs, is an important component in the treatment of cardiovascular disease. Variability in response to such medications, of which pharmacogenetic response is a major source, can decrease or enhance the benefits expected. This review is a comprehensive assessment of the literature published to date on the effects of genetic polymorphisms on the actions of a variety of antithrombotic medications, including warfarin, clopidogrel, prasugrel, and aspirin. Literature evaluating surrogate markers in addition to the impact of pharmacogenetics on clinical outcomes has been reviewed. The results of the studies are conflicting as to what degree pharmacogenetics will affect medication management in cardiovascular disease. Additional research is necessary to discover, characterize, and prospectively evaluate genetic and non-genetic factors that impact antithrombotic treatment in order to maximize the effectiveness and limit the harmful effects of these valuable agents.Keywords: aspirin, warfarin, clopidogrel, prasugrel, pharmacogenetic, antithrombotic, antiplatelet

  17. Eosinophilic Esophagitis: Clinical Features, Endoscopic Findings and Response to Treatment

    Directory of Open Access Journals (Sweden)

    Robert Enns

    2010-01-01

    Full Text Available Eosinophilic esophagitis (EE is a motility disorder of the esophagus that typically presents with dysphagia. The objective of the present study was to explore patient characteristics, clinical and endoscopic features, and response to treatment of patients with EE. Patients were selected retrospectively based on a review of biopsy results from previous endoscopies performed between 2004 and 2008. A total of 54 patients (41 men and 13 women with biopsy-proven EE were included in the study. Further information regarding the patients’ clinical and endoscopic features, and response to treatment were obtained through chart reviews and patient telephone interviews. The mean age of the patients at symptom onset was 30 years. All patients complained of dysphagia, 81% had a history of bolus obstruction, 43% had a history of asthma and 70% had a history of environmental allergies. Thirty-three per cent had a family history of asthma, while 52% had a family history of food or seasonal allergies. The most common endoscopic findings were rings and/or corrugations, which were found in 63% of patients. Swallowed fluticasone therapy resulted in symptom resolution in 74% of patients; however, 79% of these patients relapsed after discontinuing fluticasone therapy and required repeat treatments. Esophageal dilation was complication free and resulted in improvement in 80% of patients. However, 83% of those reporting improvement relapsed within one year. The clinical and endoscopic findings were similar to those found in the literature, with most patients requiring ongoing, repeated therapies. Further studies are needed to assess the safety and efficacy of treatment modalities ideally suited to patients with EE.

  18. Gut hormones, early dumping and resting energy expenditure in patients with good and poor weight loss response after Roux-en-Y gastric bypass

    DEFF Research Database (Denmark)

    Dirksen, C; Jørgensen, N B; Bojsen-Møller, K N

    2013-01-01

    Objective:To identify factors contributing to the variation in weight loss after Roux-en-Y gastric bypass (RYGB).Design:Cross-sectional study of patients with good (excess body mass index lost (EBL) >60%) and poor weight loss response (EBL 12 months after RYGB and a lean control group matched for...

  19. Assessing Goodness of Fit in Item Response Theory with Nonparametric Models: A Comparison of Posterior Probabilities and Kernel-Smoothing Approaches

    Science.gov (United States)

    Sueiro, Manuel J.; Abad, Francisco J.

    2011-01-01

    The distance between nonparametric and parametric item characteristic curves has been proposed as an index of goodness of fit in item response theory in the form of a root integrated squared error index. This article proposes to use the posterior distribution of the latent trait as the nonparametric model and compares the performance of an index…

  20. Platelet aggregation responses in clinically healthy adult llamas.

    Science.gov (United States)

    Gilbert, Rosanne M; Bird, Karyn E; Kutzler, Michelle A

    2009-03-01

    Limited information exists regarding hemostasis in camelids despite the importance of platelet function testing in the accurate identification of platelet disorders. As further importation of llamas to North America is restricted, variability in breeding stock will continue to decrease, potentially leading to an increase in heritable bleeding disorders. The objective of this study was to measure platelet aggregation responses in clinically healthy llamas and provide baseline data to which abnormal platelet function may be compared in the future. Blood samples were collected from 39 healthy adult llamas, citrated, and centrifuged to produce platelet-rich plasma (PRP). Within 4 hours of the blood draw, 20 microL of each agonist reagent were added to 180 microL of PRP. Final concentrations of agonists were 2 x 10(-5) M ADP, 0.19 mg collagen/mL PRP, 1 x 10(-4) M epinephrine, and 500 microg arachidonic acid/mL PRP. Llama platelets were most responsive to ADP and collagen, with a maximum percent aggregation (mean+/-SD) of 71.3+/-18.6% and 55.8+/-19% and aggregation rates of 9.5+/-3.9 and 6.7+/-3.7 cm/min, respectively. Llama platelet aggregation in response to epinephrine and arachidonic acid was minimal to absent. This study is the first of its kind to establish baseline values for platelet aggregation in healthy adult llamas.

  1. Gender differences in binaural speech-evoked auditory brainstem response: are they clinically significant?

    Science.gov (United States)

    Jalaei, Bahram; Azmi, Mohd Hafiz Afifi Mohd; Zakaria, Mohd Normani

    2018-05-17

    Binaurally evoked auditory evoked potentials have good diagnostic values when testing subjects with central auditory deficits. The literature on speech-evoked auditory brainstem response evoked by binaural stimulation is in fact limited. Gender disparities in speech-evoked auditory brainstem response results have been consistently noted but the magnitude of gender difference has not been reported. The present study aimed to compare the magnitude of gender difference in speech-evoked auditory brainstem response results between monaural and binaural stimulations. A total of 34 healthy Asian adults aged 19-30 years participated in this comparative study. Eighteen of them were females (mean age=23.6±2.3 years) and the remaining sixteen were males (mean age=22.0±2.3 years). For each subject, speech-evoked auditory brainstem response was recorded with the synthesized syllable /da/ presented monaurally and binaurally. While latencies were not affected (p>0.05), the binaural stimulation produced statistically higher speech-evoked auditory brainstem response amplitudes than the monaural stimulation (p0.80), substantive gender differences were noted in most of speech-evoked auditory brainstem response peaks for both stimulation modes. The magnitude of gender difference between the two stimulation modes revealed some distinct patterns. Based on these clinically significant results, gender-specific normative data are highly recommended when using speech-evoked auditory brainstem response for clinical and future applications. The preliminary normative data provided in the present study can serve as the reference for future studies on this test among Asian adults. Copyright © 2018 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  2. Is performance in pre-clinical assessment a good predictor of the final Doctor of Medicine grade?

    Science.gov (United States)

    Al-Wardy, Nadia M; Rizvi, Syed G; Bayoumi, Riad A

    2009-12-01

    To investigate if any correlation exists between students' grades on their final doctor of Medicine (MD) assessment and their overall preclinical grade point average (GPA) and its component parts. Student data available from the Deanship of Admissions and Registration were analyzed. Pearson correlation coefficient was obtained to assess the degree of linear relationship between performance in the preclinical and the MD assessment of 529 students who graduated from the College of Medicine and Health Sciences, Sultan Qaboos University, Al-Khoud, Oman from June 1998 to June 2005. Simple and multiple regression analyses were performed to evaluate individual and combined impact of the preclinical courses' grades on MD grades. Preclinical GPA correlated highly with MD GPA (r=0.641). The science component taught early in the preclinical phase correlated more strongly (r=0.457) than student electives (r=0.246). This correlation was better in the good English group. Students' performance, however, was best in electives, but worst in English. Most students who had low MD GPA (2.5, and limiting the credit hour requirement of electives by the College seems to be justified.

  3. 'A good fit?' Bringing the sociology of footwear to the clinical encounter in podiatry services: a narrative review.

    Science.gov (United States)

    Nicholls, Emily; Robinson, Victoria; Farndon, Lisa; Vernon, Wesley

    2018-01-01

    This narrative review explores the ways in which drawing on theories and methods used in sociological work on footwear and identity can contribute to healthcare research with podiatrists and their patients, highlighting recent research in this field, implications for practice and potential areas for future development.Traditionally, research within Podiatry Services has tended to adopt a quantitative, positivist focus, developing separately from a growing body of sociological work exploring the importance of shoes in constructing identity and self-image. Bringing qualitative research drawing on sociological theory and methods to the clinical encounter has real potential to increase our understanding of patient values, motivations and - crucially - any barriers to adopting 'healthier' footwear that they may encounter. Such work can help practitioners to understand why patients may resist making changes to their footwear practices, and help us to devise new ways for practitioners to explore and ultimately break down individual barriers to change (including their own preconceptions as practitioners). This, in turn, may lead to long-term, sustainable changes to footwear practices and improvements in foot health for those with complex health conditions and the wider population. A recognition of the complex links between shoes and identity is opening up space for discussion of patient resistance to footwear changes, and paving the way for future research in this field beyond the temporary 'moment' of the clinical encounter.

  4. 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...

  5. Pharmaceutical advertisements in medical journals received in a medical clinic: are we having "too much of a good thing"?

    Science.gov (United States)

    Lohiya, Sapna

    2005-05-01

    A convenience sample of all medical journals found in a medical clinic was reviewed for pharmaceutical advertisements. Ads were present in 25 (96%) of the 26 journals. Ad space varied from 0-34% (mean 12) in research, and 9-48% (mean: 36) in nonresearch journals. In 23 (88%) journals, individual ads consisted of more than one page. Colorful glossy insert-ads, of up to nine pages, were seen in 18 (69%) journals. Six (23%) journals contained more advertising than editorial pages. Many ads were longer than the longest article in that journal. Medical journals devote considerable space to pharmaceutical ads. Excessive pharmaceutical advertising may bias the journals' owners and readers and may be distracting and annoying.

  6. Good prognosis of postpartum lower limb sensorimotor deficit: a combined clinical, electrophysiological, and radiological follow-up.

    Science.gov (United States)

    Richard, A; Vellieux, G; Abbou, S; Benifla, J L; Lozeron, P; Kubis, N

    2017-03-01

    Postpartum lower limb motor and/or sensory deficit is an uncommon obstetrical complication. We aimed to identify its incidence, etiology, and precipitating factors, as well as the neurological prognosis by retrospectively analyzing the successive neurological evaluations, electrophysiological, and MRI data from all the consecutive patients with postpartum motor and/or sensory deficits of the lower limbs referred from the Lariboisière Obstetrical Department to the Lariboisière Neurophysiology Department, from January 2012 to June 2016, as well as data concerning labor and morphological characteristics of mother and baby. Thirteen patients (0.11% of the parturient women in the Lariboisière hospital) were included. Eight (62%) had lumbosacral plexopathy. Symptoms followed a first vaginal delivery in 10/13 patients (77%), in patients who were mostly overweight (mean patient BMI before pregnancy 25.6 ± 3.2 kg/m 2 ). Labor duration was slightly longer than average (mean labor duration 8.9 ± 2.9 h). No other potentially precipitating factor was identified. Recovery was good in all patients, 7/11 (64%) made a rapid full recovery (mean recovery time 5 ± 2.5 weeks excluding one patient who had a normal neurological examination at 2 weeks but still complained of foot weakness that fully recovered in 1 year), and a minority (4/11, 36%) still complained of minor symptoms at time of follow-up, but showed marked improvement. New mothers presenting postpartum lower limb nerve injury should, therefore, be reassured.

  7. Estándares de calidad en los ensayos clínicos: ISO 9001-Buena Práctica Clínica Quality standards in clinical tests. ISO 9001: Good Clinical Practice

    Directory of Open Access Journals (Sweden)

    Sandra Álvarez Guerra

    2005-12-01

    Full Text Available La calidad en los ensayos clínicos conducidos por los centros de investigación por contrato , constituye un factor de suma importancia. En la actualidad estas instituciones usan como estándar de calidad la Buena Práctica Clínica. Sin embargo, su combinación con la Norma ISO 9001:2000, estándar de calidad, internacionalmente utilizado, no se ha generalizado. Para demostrar la factibilidad que el uso conjunto de estas normas brindan a las organizaciones se decidió establecer reflexiones para demostrar cómo se complementan ambos estándares de calidad en la realización de ensayos clínicos. Para esto se revisó bibliografía actualizada en dichos temas. Se valoraron aspectos en común como: clientes, responsabilidad, tratamiento de datos generados, estadística, control de la calidad y documentos esenciales. Por medio de estos aspectos ambas normas tributan a la calidad del ensayo clínico, para una mejor protección al paciente, resultados confiables, satisfacción de los clientes, internos y externos, que garanticen la mejora continua, y establecer planes de contingencia y medidas preventivas. Se concluye que ambas normativas no están en contraposición y pueden ser utilizadas como vía capaz de garantizar excelencia en el servicio brindado.The quality of clinical tests conducted by the research centers on contract is a very important factor. Nowadays, these institutions use Good Clinical Practice as the quality standard. However, the combination of the latter with internationally used ISO 9001:2000 quality standard has not yet been generalized. In order to prove the feasibility that the joint use of these standards offers to organizations, it was decided to reflect on the way both quality standards complement each other in the performance of clinical tests. To this end, updated literature review was made. Common aspects such as clients, responsibility, treatment of data, statistics, quality control and essential documents were

  8. Making good theory practical: five lessons for an Applied Social Identity Approach to challenges of organizational, health, and clinical psychology.

    Science.gov (United States)

    Haslam, S Alexander

    2014-03-01

    Social identity research was pioneered as a distinctive theoretical approach to the analysis of intergroup relations but over the last two decades it has increasingly been used to shed light on applied issues. One early application of insights from social identity and self-categorization theories was to the organizational domain (with a particular focus on leadership), but more recently there has been a surge of interest in applications to the realm of health and clinical topics. This article charts the development of this Applied Social Identity Approach, and abstracts five core lessons from the research that has taken this forward. (1) Groups and social identities matter because they have a critical role to play in organizational and health outcomes. (2) Self-categorizations matter because it is people's self-understandings in a given context that shape their psychology and behaviour. (3) The power of groups is unlocked by working with social identities not across or against them. (4) Social identities need to be made to matter in deed not just in word. (5) Psychological intervention is always political because it always involves some form of social identity management. Programmes that seek to incorporate these principles are reviewed and important challenges and opportunities for the future are identified. © 2014 The British Psychological Society.

  9. Students' approaches to learning in a clinical practicum: A psychometric evaluation based on item response theory.

    Science.gov (United States)

    Zhao, Yue; Kuan, Hoi Kei; Chung, Joyce O K; Chan, Cecilia K Y; Li, William H C

    2018-07-01

    The investigation of learning approaches in the clinical workplace context has remained an under-researched area. Despite the validation of learning approach instruments and their applications in various clinical contexts, little is known about the extent to which an individual item, that reflects a specific learning strategy and motive, effectively contributes to characterizing students' learning approaches. This study aimed to measure nursing students' approaches to learning in a clinical practicum using the Approaches to Learning at Work Questionnaire (ALWQ). Survey research design was used in the study. A sample of year 3 nursing students (n = 208) who undertook a 6-week clinical practicum course participated in the study. Factor analyses were conducted, followed by an item response theory analysis, including model assumption evaluation (unidimensionality and local independence), item calibration and goodness-of-fit assessment. Two subscales, deep and surface, were derived. Findings suggested that: (a) items measuring the deep motive from intrinsic interest and deep strategies of relating new ideas to similar situations, and that of concept mapping served as the strongest discriminating indicators; (b) the surface strategy of memorizing facts and details without an overall picture exhibited the highest discriminating power among all surface items; and, (c) both subscales appeared to be informative in assessing a broad range of the corresponding latent trait. The 21-item ALWQ derived from this study presented an efficient, internally consistent and precise measure. Findings provided a useful psychometric evaluation of the ALWQ in the clinical practicum context, added evidence to the utility of the ALWQ for nursing education practice and research, and echoed the discussions from previous studies on the role of the contextual factors in influencing student choices of different learning strategies. They provided insights for clinical educators to measure

  10. Clinical update on benefit versus risks of oral paracetamol alone or with codeine: still a good option?

    Science.gov (United States)

    Kress, Hans Georg; Untersteiner, Gerald

    2017-02-01

    After decades of worldwide use of paracetamol/acetaminophen as a popular and apparently safe prescription and over-the-counter medicine, the future role of this poorly understood analgesic has been seriously questioned by recent concerns about prenatal, cardiovascular (CV) and hepatic safety, and also about its analgesic efficacy. At the same time the usefulness of codeine in combination products has come under debate. Based on a PubMed database literature search on the terms efficacy, safety, paracetamol, acetaminophen, codeine and their combinations up to and including June 2016, this clinical update reviews the current evidence of the benefit and risks of oral paracetamol alone and with codeine for mild-to-moderate pain in adults, and compares the respective efficacy and safety profiles with those of nonsteroidal anti-inflammatory drugs (NSAIDs). Whereas there is a clear strong association of NSAID use and gastrointestinal (GI) and CV morbidity and mortality, evidence for paracetamol with and without codeine supports the recommended use even in most vulnerable individuals, such as the elderly, pregnant women, alcoholics, and compromised GI and CV patients. The controversies and widespread misconceptions about the complex hepatic metabolism and potential hepatotoxicity have been corrected by recent reviews, and paracetamol remains the first-line nonopioid analgesic in patients with liver diseases if notes of caution are applied. Due to its safety and tolerability profile paracetamol remained a first-line treatment in many international guidelines. Alone and with codeine it is a safe and effective option in adults, whilst NSAIDs are obviously less safe as alternatives, given the risk of potentially fatal GI and CV adverse effects.

  11. A good patient?

    DEFF Research Database (Denmark)

    Campbell, Catherine; Scott, Kerry; Skovdal, Morten

    2015-01-01

    , physical cleanliness, honesty, gratitude and lifestyle adaptations (taking pills correctly andcoming to the clinic when told). As healthcare workers may decide to punish patients who do not live up the‘good patient persona’, many patients seek to perform within the confines of the ‘good patient persona...

  12. [Is "mental health" part of the common good? The sociopolitical framework of psychiatric ethics and the responsibility of health-care elites].

    Science.gov (United States)

    Bohlken, Eike

    2014-07-01

    Psychiatric work can only be that ethical as the framework of a health-care system allows. Thus, the responsibility of the health-care elites to establish a sociopolitical framework that suits psychiatric ethics is discussed on the basis of a theory of the common good and of a philosophical and normative elite theory. "Mental health" is demonstrated to be part of a basic sphere of the common good which cannot be denied to any member of a society. The final section discusses which specific duties can be derived for health-care elites on the ground of the aforementioned conception of "mental health" as a part of the common good. © Georg Thieme Verlag KG Stuttgart · New York.

  13. GOODS-Herschel: identification of the individual galaxies responsible for the 80-290 μm cosmic infrared background

    Science.gov (United States)

    Leiton, R.; Elbaz, D.; Okumura, K.; Hwang, H. S.; Magdis, G.; Magnelli, B.; Valtchanov, I.; Dickinson, M.; Béthermin, M.; Schreiber, C.; Charmandaris, V.; Dole, H.; Juneau, S.; Le Borgne, D.; Pannella, M.; Pope, A.; Popesso, P.

    2015-07-01

    Aims: We propose a new method of pushing Herschel to its faintest detection limits using universal trends in the redshift evolution of the far infrared over 24 μm colours in the well-sampled GOODS-North field. An extension to other fields with less multi-wavelength information is presented. This method is applied here to raise the contribution of individually detected Herschel sources to the cosmic infrared background (CIRB) by a factor 5 close to its peak at 250 μm and more than 3 in the 350 and 500 μm bands. Methods: We produce realistic mock Herschel images of the deep PACS and SPIRE images of the GOODS-North field from the GOODS-Herschel key program and use them to quantify the confusion noise at the position of individual sources, i.e., estimate a "local confusion noise". Two methods are used to identify sources with reliable photometric accuracy extracted using 24 μm prior positions. The clean index (CI), previously defined but validated here with simulations, which measures the presence of bright 24 μm neighbours and the photometric accuracy index (PAI) directly extracted from the mock Herschel images. Results: Both methods converge to comparable depths and fractions of the CIRB resolved into sources individually detected with Herschel. After correction for completeness, thanks to our mock Herschel images, individually detected sources make up as much as 54% and 60% of the CIRB in the PACS bands down to 1.1 mJy at 100 μm and 2.2 mJy at 160 μm and 55, 33, and 13% of the CIRB in the SPIRE bands down to 2.5, 5, and 9 mJy at 250 μm, 350 μm, and 500 μm, respectively. The latter depths improve the detection limits of Herschel by factors of 5 at 250 μm, and 3 at 350 μm and 500 μm as compared to the standard confusion limit. Interestingly, the dominant contributors to the CIRB in all Herschel bands appear to be distant siblings of the Milky Way (z ~ 0.96 for λ< 300 μm) with a stellar mass of M⋆ ~ 9 × 1010M⊙.

  14. Accidental goodness?

    DEFF Research Database (Denmark)

    Richter, Anne

    In postmodern capitalist market economies, management of the single organisation is bound to be guided by several rationales, which are in conflict with each other. For some writers this perception leads to the argument, that conceptions of management should strive towards goals beyond the present...... society. For others, the handling of plural perspectives is just a management discipline. However these positions seem to share a focus on organization as a the arena for the organization of the good. The contribution looks at the management of occupational accidents as an example of striving for good...

  15. Finally Making Good on the Promise of Qualitative Research in Special Education? A Response to the Special Issue

    Science.gov (United States)

    Pugach, Marleen C.; Mukhopadhyay, Ananya; Gomez-Najarro, Joyce

    2014-01-01

    In this response to the special issue, we would like to offer two additional considerations to the discourse on qualitative research and special education this issue is meant to catalyze. First, we would like to further problematize the question of why qualitative research continues to be so sparsely represented in most prominent publications of…

  16. Refractory myasthenia gravis - clinical profile, comorbidities and response to rituximab.

    Science.gov (United States)

    Sudulagunta, Sreenivasa Rao; Sepehrar, Mona; Sodalagunta, Mahesh Babu; Settikere Nataraju, Aravinda; Bangalore Raja, Shiva Kumar; Sathyanarayana, Deepak; Gummadi, Siddharth; Burra, Hemanth Kumar

    2016-01-01

    Introduction: Myasthenia gravis (MG) is an antibody mediated autoimmune neuromuscular disorder characterized by fatigable muscle weakness. A proportion of myasthenia gravis patients are classified as refractory due to non responsiveness to conventional treatment. This retrospective study was done to evaluate clinical profile, epidemiological, laboratory, and features of patients with MG and mode of management using rituximab and complications. Methods: Data of myasthenia gravis patients admitted or presented to outpatient department (previous medical records) with MG between January 2008 and January 2016 were included. A total of 512 patients fulfilled the clinical and diagnostic criteria of myasthenia gravis of which 76 patients met the diagnostic certainty for refractory myasthenia gravis and were evaluated. Results: Out of 76 refractory MG patients, 53 (69.73%) patients fulfilled all the three defined criteria. The median age of onset of the refractory MG group was 36 years with a range of 27-53 years. In our study 25 patients (32.89%) belonged to the age group of 21-30 years. Anti-MuSK antibodies were positive in 8 non-refractory MG patients (2.06%) and 36 refractory MG patients (47.36%). Mean HbA 1C was found to be 8.6±2.33. The dose of administered prednisone decreased by a mean of 59.7% ( p =3.3x10 -8 ) to 94.6% ( p =2.2x10 -14 ) after the third cycle of rituximab treatment. Conclusion: The refractory MG patients are most commonly female with an early age of onset, anti-MuSK antibodies, and thymomas. Refractory MG patients have higher prevalence and poor control (HbA 1C >8%) of diabetes mellitus and dyslipidemia probably due to increased steroid usage. Rituximab is very efficient in treatment of refractory MG with adverse effects being low.

  17. X-linked acrogigantism syndrome: clinical profile and therapeutic responses.

    Science.gov (United States)

    Beckers, Albert; Lodish, Maya Beth; Trivellin, Giampaolo; Rostomyan, Liliya; Lee, Misu; Faucz, Fabio R; Yuan, Bo; Choong, Catherine S; Caberg, Jean-Hubert; Verrua, Elisa; Naves, Luciana Ansaneli; Cheetham, Tim D; Young, Jacques; Lysy, Philippe A; Petrossians, Patrick; Cotterill, Andrew; Shah, Nalini Samir; Metzger, Daniel; Castermans, Emilie; Ambrosio, Maria Rosaria; Villa, Chiara; Strebkova, Natalia; Mazerkina, Nadia; Gaillard, Stéphan; Barra, Gustavo Barcelos; Casulari, Luis Augusto; Neggers, Sebastian J; Salvatori, Roberto; Jaffrain-Rea, Marie-Lise; Zacharin, Margaret; Santamaria, Beatriz Lecumberri; Zacharieva, Sabina; Lim, Ee Mun; Mantovani, Giovanna; Zatelli, Maria Chaira; Collins, Michael T; Bonneville, Jean-François; Quezado, Martha; Chittiboina, Prashant; Oldfield, Edward H; Bours, Vincent; Liu, Pengfei; W de Herder, Wouter; Pellegata, Natalia; Lupski, James R; Daly, Adrian F; Stratakis, Constantine A

    2015-06-01

    X-linked acrogigantism (X-LAG) is a new syndrome of pituitary gigantism, caused by microduplications on chromosome Xq26.3, encompassing the gene GPR101, which is highly upregulated in pituitary tumors. We conducted this study to explore the clinical, radiological, and hormonal phenotype and responses to therapy in patients with X-LAG syndrome. The study included 18 patients (13 sporadic) with X-LAG and microduplication of chromosome Xq26.3. All sporadic cases had unique duplications and the inheritance pattern in two families was dominant, with all Xq26.3 duplication carriers being affected. Patients began to grow rapidly as early as 2-3 months of age (median 12 months). At diagnosis (median delay 27 months), patients had a median height and weight standard deviation scores (SDS) of >+3.9 SDS. Apart from the increased overall body size, the children had acromegalic symptoms including acral enlargement and facial coarsening. More than a third of cases had increased appetite. Patients had marked hypersecretion of GH/IGF1 and usually prolactin, due to a pituitary macroadenoma or hyperplasia. Primary neurosurgical control was achieved with extensive anterior pituitary resection, but postoperative hypopituitarism was frequent. Control with somatostatin analogs was not readily achieved despite moderate to high levels of expression of somatostatin receptor subtype-2 in tumor tissue. Postoperative use of adjuvant pegvisomant resulted in control of IGF1 in all five cases where it was employed. X-LAG is a new infant-onset gigantism syndrome that has a severe clinical phenotype leading to challenging disease management. © 2015 Society for Endocrinology.

  18. Good Faith

    DEFF Research Database (Denmark)

    Fomcenco, Alex

    2017-01-01

    This article outlines the current state of law in Canada in respect to good faith in contratial relations. The topic is highly relevant due to expected growth in the numbers of contracts concluded between European and Canadian enterprises in the wake of adoption of the Comprehensive Economic...

  19. Clinical study of the histologic host response of the patients with lung cancer during radiotherapy

    International Nuclear Information System (INIS)

    Gose, Kyuhei

    1984-01-01

    Serial bronchofiberscopic biopsies were performed during radiotherapy in 28 patients with squamous cell carcinoma of the lung. The effect of radiotherapy on tumor tissue was examined histologically as to the responsiveness of the host against tumor cells. The mononuclear cell infiltration induced in the tumor by irradiation correlated well with its direct effect on the tumor cells. The most remarkable infiltration was observed at the dose of 2000 rad and in the polypoid type. Indirect immunofluonescent technique with monoclonal anti OKT 3 and OKIa revealed that most of the infiltrated cells were T-lymphocytes. There was a good relationship between the grade of mononuclear cell infiltration and the survival period. These facts suggest that the mononuclear cells in the irradiated tumor tissues represent host resistance against cancer and the intensity of the infiltration correlates with the clinical course and prognosis of the lung cancer patients. (author)

  20. Hypertensive response to exercise: mechanisms and clinical implication.

    Science.gov (United States)

    Kim, Darae; Ha, Jong-Won

    2016-01-01

    A hypertensive response to exercise (HRE) is frequently observed in individuals without hypertension or other cardiovascular disease. However, mechanisms and clinical implication of HRE is not fully elucidated. Endothelial dysfunction and increased stiffness of large artery contribute to development of HRE. From neurohormonal aspects, excess stimulation of sympathetic nervous system and augmented rise of angiotensin II seems to be important mechanism in HRE. Increasing evidences indicates that a HRE is associated with functional and structural abnormalities of left ventricle, especially when accompanied by increased central blood pressure. A HRE harbors prognostic significance in future development of hypertension and increased cardiovascular events, particularly if a HRE is documented in moderate intensity of exercise. As supported by previous studies, a HRE is not a benign phenomenon, however, currently, whether to treat a HRE is controversial with uncertain treatment strategy. Considering underlying mechanisms, angiotensin receptor blockers and beta blockers can be suggested in individuals with HRE, however, evidences for efficacy and outcomes of treatment of HRE in individuals without hypertension is scarce and therefore warrants further studies.

  1. Autophagy in the immune response to tuberculosis: clinical perspectives.

    LENUS (Irish Health Repository)

    Ní Cheallaigh, C

    2011-06-01

    A growing body of evidence points to autophagy as an essential component in the immune response to tuberculosis. Autophagy is a direct mechanism of killing intracellular Mycobacterium tuberculosis and also acts as a modulator of proinflammatory cytokine secretion. In addition, autophagy plays a key role in antigen processing and presentation. Autophagy is modulated by cytokines; it is stimulated by T helper type 1 (Th1) cytokines such as tumour necrosis factor (TNF)-α and interferon (IFN)-γ, and is inhibited by the Th2 cytokines interleukin (IL)-4 and IL-13 and the anti-inflammatory cytokine IL-10. Vitamin D, via cathelicidin, can also induce autophagy, as can Toll-like receptor (TLR)-mediated signals. Autophagy-promoting agents, administered either locally to the lungs or systemically, could have a clinical application as adjunctive treatment of drug-resistant and drug-sensitive tuberculosis. Moreover, vaccines which effectively induce autophagy could be more successful in preventing acquisition or reactivation of latent tuberculosis.

  2. TS gene polymorphisms are not good markers of response to 5-FU therapy in stage III colon cancer patients.

    Science.gov (United States)

    Fariña-Sarasqueta, A; Gosens, M J E M; Moerland, E; van Lijnschoten, I; Lemmens, V E P P; Slooter, G D; Rutten, H J T; van den Brule, Adriaan J C

    2011-08-01

    Although the predictive and prognostic value of thymidylate synthase (TS) expression and gene polymorphism in colon cancer has been widely studied, the results are inconclusive probably because of methodological differences. With this study, we aimed to elucidate the role of TS gene polymorphisms genotyping in therapy response in stage III colon carcinoma patients treated with 5-FU adjuvant chemotherapy. 251 patients diagnosed with stage III colon carcinoma treated with surgery followed by 5-FU based adjuvant therapy were selected. The variable number of tandem repeats (VNTR) and the single nucleotide polymorphism (SNP) in the 5'untranslated region of the TS gene were genotyped. There was a positive association between tumor T stage and the VNTR genotypes (p = 0.05). In both univariate and multivariate survival analysis no effects of the studied polymorphisms on survival were found. However, there was an association between both polymorphisms and age. Among patients younger than 60 years, the patients homozygous for 2R seemed to have a better overall survival, whereas among the patients older than 67 this longer survival was seen by the carriers of other genotypes. We conclude that the TS VNTR and SNP do not predict response to 5-FU therapy in patients with stage III colon carcinoma. However, age appears to modify the effects of TS polymorphisms on survival.

  3. Systemic Epstein-Barr Virus-positive T-Cell Lymphoproliferative Disease of Childhood With Good Response to Steroid Therapy.

    Science.gov (United States)

    Kim, Do-Hoon; Kim, Myungshin; Kim, Yonggoo; Han, Kyungja; Han, Eunhee; Lee, Jae Wook; Chung, Nack-Gyun; Cho, Bin

    2017-11-01

    Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoproliferative disease of childhood is a rare disease and has a very fulminant clinical course with high mortality. A 21-month-old female patient was referred to our hospital with a 1 week history of fever and was subsequently diagnosed with systemic Epstein-Barr virus-positive T-cell lymphoproliferative disease of childhood. After starting treatment with dexamethasone, she showed early defervescence and improvement of laboratory parameters, and has remained disease-free after stopping steroid treatment, although longer follow-up is necessary. Our report underscores the possibility that this disease entity may be heterogenous in terms of prognosis.

  4. Clinical profile and response to treatment of patients with pituitary adenomas submitted to radiotherapy

    International Nuclear Information System (INIS)

    Moraes, Paulo Lazaro de; Freire, Geison Moreira; Dias, Rodrigo Souza; Segreto, Roberto Araujo; Segreto, Helena Regina Comodo; Abucham Filho, Julio Zaki

    2008-01-01

    Objective: to evaluate the clinical profile of patients with pituitary adenoma and their response to radiotherapy. Material and method: retrospective study with 22 patients with diagnosis of pituitary adenoma which were submitted to radiotherapy between March 2004 and December 2008. Patients' characteristics such as gender, age, clinical presentation, surgical approach, immunohistochemistry profile, dose of radiation and the response to therapy were analyzed using hormonal dosages and imaging exams. Results: the median age was 51 years and equally distributed in both genders. The tumors were divided according to the Hardy's classification: 27.5% had grade II, 27.5% had grade III and 45% had grade IV. The main symptoms presented by patients at diagnosis were visual impairment in 77% of cases, headache in 68%, amenorrhea and acromegaly in 27% and galactorrhoea in 4.5%. Transphenoidal surgery was performed in 21 patients and only 1 patient was submitted to transcranial approach; 91% of cases had partial resection. Concerning to immunohistochemistry, the expression of ACTH was the most frequent, being present in 41% of cases. The patients were treated in megavoltage equipment mostly with 6 MV linear accelerator. The total radiation dose was 45 Gy in 68% of patients and a dose of 50.4 Gy in 13% of cases. Three-dimensional planning was used in 20 patients. The median follow-up was 41 months. Laboratory and imaging improvement were observed in 73% of patients, stability in 22.5%, and worsening in 4.5%. Conclusion: the results show good rates of response and control of pituitary adenomas by radiation in the first four years after treatment. Considering it has a slow response to treatment, there is a high chance of improvement in results later during the follow-up. (author)

  5. [Clinical and biological predictors of ketamine response in treatment-resistant major depression: Review].

    Science.gov (United States)

    Romeo, B; Choucha, W; Fossati, P; Rotge, J-Y

    2017-08-01

    attention tests were also predictive to a good response. These predictive factors could be more specific to ketamine. With these different predictor factors (clinical and biological), it could be interesting to develop clinical strategies to personalize ketamine's administration. Copyright © 2016 L'Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  6. How good is this food? A study on dogs' emotional responses to a potentially pleasant event using infrared thermography.

    Science.gov (United States)

    Travain, Tiziano; Colombo, Elisa Silvia; Grandi, Laura Clara; Heinzl, Eugenio; Pelosi, Annalisa; Prato Previde, Emanuela; Valsecchi, Paola

    2016-05-15

    Understanding how animals express positive emotions is becoming an interesting and promising area of research in the study of animal emotions and affective experiences. In the present study, we used infrared thermography in combination with behavioral measures, heart rate (HR) and heart rate variability (HRV), to investigate dogs' emotional responses to a potentially pleasant event: receiving palatable food from the owner. Nineteen adult pet dogs, 8 females and 11 males, were tested and their eye temperature, HR, HRV and behavior were recorded during a 30-minutestestconsisting of three 10-minute consecutive phases: Baseline (Phase 1), positive stimulation through the administration of palatable treats (Feeding, Phase 2) and Post-feeding condition following the positive stimulation (Phase 3). Dogs' eye temperature and mean HR significantly increased during the positive stimulation phase compared with both Baseline and Post-feeding phases. During the positive stimulation with food (Phase 2), dogs engaged in behaviors indicating a positive emotional state and a high arousal, being focused on food treats and increasing tail wagging. However, there was no evidence of an increase in HRV during Phase 2 compared to the Phase 1, with SDNN significantly increasing only in Phase 3, after the positive stimulation occurred. Overall results point out that IRT may be a useful tool in assessing emotional states in dogs in terms of arousal but fails to discriminate emotional valence, whose interpretation cannot disregard behavioral indexes. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2011-03-28

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

  8. Clinical profile of congenital adrenal hyperplasia and short-term response to treatment

    International Nuclear Information System (INIS)

    Lal, S.; Lal, S.; Jamro, B.U.; Jamro, S.

    2015-01-01

    To determine the clinical presentation of congenital adrenal hyperplasia and short- term response to treatment. Background: Congenital adrenal hyperplasia (CAH) is a genetic disorder which usually presents with life threatening emergencies. Awareness of physicians regarding these presentations is an essential for early diagnosis and lifesaving treatment. In view of the prevalence of the condition as reported from tertiary care centers within the country and other parts of the globe, we had carried out a study in the paediatric department of Shaheed Mohtrama Benazir Bhutto Medical University Larkana. Material and Methods: The study was conducted over a period of one year from July 2012 to June 2013. All infants presenting with vomiting, dehydration, shock, failure to thrive and ambiguous genitalia were examined and investigated thoroughly. The diagnosis was based upon a raised level of serum 17 OHP in a child with suggestive clinical features. Results: A total of 40 children were diagnosed to have CAH during the study period. The major presenting features were vomiting in 13 (32.5%), ambiguous genitalia 17 (42.5%), vomiting and ambiguous genitalia 10 (25%), shock 5(12.5%) and failure to thrive in 13 (32.5%) of cases. All the patients were followed up after initiation of treatment and good response was observed to short-term treatment. Conclusion: This study highlights the importance of common clinical features like vomiting, unreasonable dehydration, shock and ambiguous genitalia being the presenting features of CAH and the effectiveness of replacement therapy in amending life threatening emergencies due to this condition. (author)

  9. 'It's a matter of patient safety': understanding challenges in everyday clinical practice for achieving good care on the surgical ward - a qualitative study.

    Science.gov (United States)

    Jangland, Eva; Nyberg, Berit; Yngman-Uhlin, Pia

    2017-06-01

    Surgical care plays an important role in the acute hospital's delivery of safe, high-quality patient care. Although demands for effectiveness are high in surgical wards quality of care and patient safety must also be secured. It is therefore necessary to identify the challenges and barriers linked to quality of care and patient safety with a focus on this specific setting. To explore situations and processes that support or hinder good safe patient care on the surgical ward. This qualitative study was based on a strategic sample of 10 department and ward leaders in three hospitals and six surgical wards in Sweden. Repeated reflective interviews were analysed using systematic text condensation. Four themes described the leaders' view of a complex healthcare setting that demands effectiveness and efficiency in moving patients quickly through the healthcare system. Quality of care and patient safety were often hampered factors such as a shift of care level, with critically ill patients cared for without reorganisation of nurses' competencies on the surgical ward. There is a gap between what is described in written documents and what is or can be performed in clinical practice to achieve good care and safe care on the surgical ward. A shift in levels of care on the surgical ward without reallocation of the necessary competencies at the patient's bedside show consequences for quality of care and patient safety. This means that surgical wards should consider reviewing their organisation and implementing more advanced nursing roles in direct patient care on all shifts. The ethical issues and the moral stress on nurses who lack the resources and competence to deliver good care according to professional values need to be made more explicit as a part of the patient safety agenda in the surgical ward. © 2016 Nordic College of Caring Science.

  10. Manipulation of the metabolic response in clinical practice

    DEFF Research Database (Denmark)

    Kehlet, H

    2000-01-01

    morbidity. Effective afferent neural blockade with continuous epidural local anesthetic techniques inhibits a major part of the endocrine metabolic response, leading to improved protein economy but without important effects on inflammatory or immunologic responses. In contrast, pain treatment with other...... modalities such as nonsteroidal antiinflammatory drugs (NSAIDs) and opioids has only a small inhibitory effect on endocrine metabolic responses. Preoperative high-dose glucocorticoid therapy provides additional pain relief and improves pulmonary function, but it reduces the inflammatory response (acute......-phase proteins, cytokines, hyperthermia) and immune function. Minimally invasive surgery leaves the endocrine metabolic responses largely unaltered but reduces the inflammatory response and immune suppression. Thus several techniques are available to modify the stress responses in elective surgery patients...

  11. Equally good fixation of cemented and uncemented cups in total trapeziometacarpal joint prostheses. A randomized clinical RSA study with 2-year follow-up.

    Science.gov (United States)

    Hansen, Torben Baek; Stilling, Maiken

    2013-02-01

    Cup failure is a recognized problem in total trapeziometacarpal (TM) joint prostheses; it may be related to poor fixation, which can be revealed by radiostereometric analysis (RSA). We compared the early implant migration of cemented trapezium cups to that of uncemented screw cups. In a prospective, parallel-group, randomized patient-blinded clinical trial, we included 32 hands in 28 patients (5 males) with a mean age of 58 (40-77) years and with Eaton stage-2 or -3 osteoarthritis of the trapeziometacarpal joint. Patients were randomized to surgery with a cemented DLC all-polyethylene cup (C) (n = 16) or an uncemented hydroxyapatite-coated chrome-cobalt Elektra screw cup (UC) (n = 16). Uncemented cups were inserted without threading of the bone. Stereoradiographs for evaluation of cup migration (primary effect size) and DASH and pain scores were obtained during 2 years of follow-up. The 2-year total translation (TT) was similar (p = 0.2): 0.24 mm (SD 0.10) for the C (n = 11) and 0.19 mm (SD 0.16) for the UC (n = 11). Variances were similar (p = 0.4). Judged by RSA, 2 UC cups and 1 C cup became loose (TT > 1 mm). Both UC cups were found to be loose at revision. Grip strength, pain, and DASH scores were similar between groups at all measurement points. Early implant fixation and clinical outcome were equally good with both cup designs. This is the first clinical RSA study on trapezium cups, and the method appears to be clinically useful for detection of loose implants.

  12. Software licenses: Good fences make good neighbors

    International Nuclear Information System (INIS)

    McCreary, J.G.; Woodyard, A.

    1995-01-01

    The basis for a good contract is that it is beneficial to both parties. A good foundation will cement the responsibilities and obligations of the parties after areas of agreement have been negotiated. Unfortunately, software licenses do not always reflect what is best for all. Some clauses are definitely for the benefit of the vendor, while others are required by a prudent client. The resulting contract is then a matter of reasonable compromise to achieve a good business relationship. Major issues of warranty, liability, training, support, and payment may be in conflict. Such topics as maintenance, testing, patents, extent of use, and return of software are often overlooked or addressed unevenly. This paper addresses these subjects and provides guidelines for software licenses. An understanding of legal phrases is of value. A better understanding of the viewpoints of both the vendor and the client results in a better working relationship

  13. Educational climate seems unrelated to leadership skills of clinical consultants responsible of postgraduate medical education in clinical departments

    DEFF Research Database (Denmark)

    Malling, Bente Vigh; Mortensen, Lene S.; Scherpbier, Albert J J

    2010-01-01

    The educational climate is crucial in postgraduate medical education. Although leaders are in the position to influence the educational climate, the relationship between leadership skills and educational climate is unknown. This study investigates the relationship between the educational climate...... in clinical departments and the leadership skills of clinical consultants responsible for education....

  14. A clinical clerkship collaborative program in Taiwan: Acquiring core clinical competencies through patient care responsibility

    Directory of Open Access Journals (Sweden)

    Yong A. Wang

    2016-06-01

    Conclusion: This pilot collaborative program presented a successful model for clinical education in the teaching of core clinical competencies through direct patient care responsibilities at the clerkship stage. It is hoped that the project will become a catalyst for medical education reform in Taiwan and regions with similar traditions.

  15. Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

    Science.gov (United States)

    Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

    Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing

  16. Optical signal response pf the alanine gel solution for photons and electrons clinical beams

    International Nuclear Information System (INIS)

    Silva, Cleber Feijo; Campos, Leticia Lucente

    2009-01-01

    Alanine gel dosimeter is a new gel material developed at IPEN that presents significant improvement on previous alanine systems developed by Costa (1994). The measure technique is based on the transformation of ferrous ions (Fe 2+ ) in ferric ions (Fe 3+ ) after irradiation. The DL-Alanine (C 3 H 7 NO 2 ) is an aminoacid tissue equivalent that improves the production of ferric ions in the solution. This work aims to study the comparison of optical signal response of the alanine gel solution for photons and electrons clinical beams. It was observed that the calibration factor can be considered independent of quality of the radiation for photons and electrons clinical beams. Therefore, it can be used the same calibration factor for evaluating the absorbed dose in photons and electrons fields in the energy of 6 MeV. Alanine Gel Dosimeter presents good performance and can be useful as alternative dosimeter in the radiotherapy area using MRI technique for 3D dose distribution evaluation. (author)

  17. Done good.

    Science.gov (United States)

    Caplan, A L

    2015-01-01

    How did bioethics manage to grow, flourish and ultimately do so well from a very unpromising birth in the 1970s? Many explanations have been advanced. Some ascribe the field's growth to a puzzling, voluntary abnegation of moral authority by medicine to non-physicians. Some think bioethics survived by selling out to the biomedical establishment-public and private. This transaction involved bestowing moral approbation on all manner of biomedicine's doings for a seat at a well-stocked funding table. Some see a sort of clever intellectual bamboozlement at work wherein bioethicists pitched a moral elixir of objective expertise that the morally needy but unsophisticated in medicine and the biological sciences were eager to swallow. While each of these reasons has its defenders, I think the main reason that bioethics did well was that it did good. By using the media to move into the public arena, the field engaged the public imagination, provoked dialogue and debate, and contributed to policy changes that benefitted patients and healthcare providers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  18. Gender differences in the neural response to acupuncture: Clinical implications

    NARCIS (Netherlands)

    Yeo, S.; Rosen, B.; Bosch, M.P.C.; Noort, M.W.M.L. van den; Lim, S.

    2016-01-01

    Objective: To examine gender differences and similarities in the psychophysical and brain responses to acupuncture at GB34, a point that is frequently used to treat motor function issues in Traditional Chinese Medicine. Methods: Functional MRI (fMRI) was used to measure brain activation in response

  19. Haloperidol plasmatic levels and their clinical response to the treatment

    International Nuclear Information System (INIS)

    Cabranes, J.A.; Almoguera, I.; Santos, J.L.; Prieto, P.; Ramos, J.A.

    1988-01-01

    Schizophrenic patients were treated with haloperidol. Their haloperidol levels in plasma were determined with radioimmunoassay (RIA) and radioreceptor assay (RRA). The results obtained are compared with the clinical improvement. (M.C.B.)

  20. RBE and clinical response in radiotherapy with neutron beams

    International Nuclear Information System (INIS)

    Ellis, F.

    1984-01-01

    Consideration of the clinical results reported, when a cyclotron produced neutron beam was used for treatments in the pelvis region, suggested that a constant RBE of 3 should not have been used for all neutron doses. Instead a variable RBE, which increased from approximately 3 to 8 (with decreasing dose), should have been used. Although some of these RBE values are much higher than 3, they have been observed in clinical practice. An ''equivalent photon'' isodose plan was produced by employing a variable RBE and, by taking a TDF limit of 86 for bowel, an isoeffect plan was produced. This shows that in the clinical situation under consideration much of the pelvis was overdosed. Doses to tumour cells and late effects are also briefly considered. It is suggested that, in neutron therapy, both an ''equivalent photon'' isodose plan and an isoeffect plan should be produced prior to treatment. (author)

  1. A method to adjust radiation dose-response relationships for clinical risk factors

    DEFF Research Database (Denmark)

    Appelt, Ane Lindegaard; Vogelius, Ivan R

    2012-01-01

    Several clinical risk factors for radiation induced toxicity have been identified in the literature. Here, we present a method to quantify the effect of clinical risk factors on radiation dose-response curves and apply the method to adjust the dose-response for radiation pneumonitis for patients...

  2. Definition of treatment response in rheumatoid arthritis based on the simplified and the clinical disease activity index.

    Science.gov (United States)

    Aletaha, Daniel; Martinez-Avila, Jose; Kvien, Tore K; Smolen, Josef S

    2012-07-01

    The simplified disease activity index (SDAI) and the clinical disease activity index (CDAI) are established instruments to measure disease activity in rheumatoid arthritis (RA). To date, no validated response definitions for the SDAI and CDAI are available. The authors aimed to define minor, moderate and major response criteria for the SDAI. The authors used data from two clinical trials on infliximab versus methotrexate in early (ASPIRE) or established (ATTRACT) RA, and identified the three SDAI cutpoints based on the best agreement (by κ statistics) with the American College of Rheumatology (ACR)20/50/70 responses. Cutpoints were then tested for different aspects of validity in the trial datasets and in a Norwegian disease modifying antirheumatic drug prescription dataset (NOR-DMARD). Based on agreement with the ACR response, the minor, moderate and major responses were identified as SDAI 50%, 70% and 85% improvement. These cutpoints had good face validity concerning the disease activity states achieved by the different response definitions. Construct validity was shown by a clear association of increasing SDAI response categories with increasing levels of functional improvement, achievement of better functional states and lower annual radiographic progression. Across SDAI 50/70/85, the sensitivities regarding a patient-perceived improvement decreased (73%/39%/22%) and the specificities increased (61%/89%/96%) in a meaningful way. Further, the cutpoints discriminated the different treatment arms in ASPIRE and ATTRACT. The same cutpoints were used for the CDAI, with similar results in the validation analyses. These new response criteria expand the usefulness of the SDAI and CDAI for their use as endpoints in clinical trials beyond the definition of disease activity categories.

  3. Breakthrough cancer pain (BTcP): a synthesis of taxonomy, pathogenesis, therapy, and good clinical practice in adult patients in Italy.

    Science.gov (United States)

    Zucco, Furio; Bonezzi, Cesare; Fornasari, Diego

    2014-07-01

    Pain presents in 80% of patients with advanced cancer, and 30% have periods of increased pain due to fluctuating intensity, known as breakthrough cancer pain (BTcP). BTcP is high-intensity, short-duration pain occurring in several episodes per day and is non-responsive to treatment. The clinical approach to BTcP is variable. A review of the literature was performed to provide clinicians and practitioners with a rational synthesis of the ongoing scientific debate on BTcP and to provide a basis for optimal clinical approach to BTcP in adult Italian patients. Data show that circadian exacerbations of pain should be carefully monitored, differentiating, if possible, between fluctuations of background pain (BP), end-of-dose effect, and BTcP. BTcP should be monitored in all care contexts in clinical practice and each care facility must have all the medications and products approved for use in BTcP at their disposal. Data show that knowledge about medications for BTcP is lacking: medications for BTcP treatment are not interchangeable, although containing the same active substance; each physician must know the specific characteristics of each medication, its pharmacological properties, limitations in clinical practice, specifics relating to titration and repeatability of administration, and technical specifics relating to the accessibility and delivery. Importantly, before choosing a rapid-onset opioid (ROO), it is essential to deeply understand the status of patient and the characteristics of their family unit/caregivers, taking into account the patient's progressive loss of autonomy and/or cognitive-relational functionality. When BTcP therapy is initiated or changed, special attention must be paid to training the patient and family members/caregivers, providing clear instructions regarding the timing of drug administration. The patient must already be treated effectively with opioids before introducing ROOs for control of BTcP.

  4. The putative catalytic role of higher serotonin bioavailability in the clinical response to exposure and response prevention in obsessive-compulsive disorder

    Directory of Open Access Journals (Sweden)

    Thiago Sampaio

    Full Text Available Objective: Exposure and response prevention (ERP is effective to treat obsessive-compulsive disorder (OCD, but the lack of tolerance to the aversion nature of exposure techniques results in a high drop-out rate. There have been reports of a generic stress endurance effect of serotonin (5-HT in the central nervous system (CNS which might be explained by suppression of defensive fixed action patterns. Previous studies have proposed that higher baseline 5-HT concentration and slow decrease in concentration during drug treatment of OCD were predictors of good clinical response to 5-HT reuptake inhibitors. The objective of this study was to investigate whether pre-treatment platelet rich plasma (PRP 5-HT concentration is associated with latency of treatment response and final response to an ERP protocol for obsessive-compulsive disorder (OCD. Methods: Thirty adult and treatment-free OCD patients were included in an 8-week, 16-session ERP protocol. 5-HT concentration was determined at baseline and after treatment. Patients with a reduction ≥30% on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS at the end of ERP were defined as responders. Results: A positive correlation between baseline 5-HT concentration and reduction of symptoms on the Y-BOCS was observed after 4 weeks. Baseline 5-HT concentration was not correlated with clinical response after 8 weeks of ERP, possibly due to the similar though delayed clinical response of patients with lower (compared to those with higher baseline 5-HT concentration. Patients with higher 5-HT baseline concentration also showed more improvement in depressive symptoms with treatment. Conclusion: The present results partially support the hypothesis of a stress endurance effect of 5-HT in OCD patients. According to the literature, fast onset responders possibly have more or larger 5-HT containing neurons, higher endogenous 5-HT synthesis or lower monoamine oxidase activity; all these hypotheses remain to be

  5. It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.

    Science.gov (United States)

    Ravinetto, Raffaella; Tinto, Halidou; Diro, Ermias; Okebe, Joseph; Mahendradhata, Yodi; Rijal, Suman; Gotuzzo, Eduardo; Lutumba, Pascal; Nahum, Alain; De Nys, Katelijne; Casteels, Minne; Boelaert, Marleen

    2016-01-01

    The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of 'externally sponsored' trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes de facto guide national legislators and funding agencies, so the current shortcomings may weaken the regulatory oversight of international research. In addition, activities neglected by GCP are less likely to be implemented or funded. If GCP are meant to serve the interests of global society, a comprehensive revision is needed. The revised guidelines should be strongly rooted in ethics, sensitive to different sociocultural perspectives, and allow consideration for trial-specific and context-specific challenges. This can be only achieved if all stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients' representatives from LMICs, as well as non-commercial researchers and sponsors from affluent countries, are transparently involved in the revision process. We hope that our limited analysis would foster advocacy for a broad and inclusive revision of the international GCP codes, to make them at the same time 'global

  6. [Cryptogenic West syndrome: Clinical profile, response to treatment and prognostic factors].

    Science.gov (United States)

    Calderón Romero, María; Arce Portillo, Elena; López Lobato, Mercedes; Muñoz Cabello, Beatriz; Blanco Martínez, Bárbara; Madruga Garrido, Marcos; Alonso Luego, Olga

    2017-12-06

    West syndrome (WS) is an age-dependent epileptic encephalopathy in which the prognosis varies according to the, not always identified, underlying origin. To define the profile of cryptogenic (a least studied isolated sub-group) WS, in Spain. To study its outcome, response to different treatments, and to establish prognostic factors. The study included a review of the medical records of 16 patients diagnosed with cryptogenic WS during the period, 2000-2015. The mean follow-up time was 6.6 years, with a minimum of 2 years. The large majority (11/16) were male. The mean age at onset was 6 months, and 6/16 had a family history of idiopathic epilepsy. The first line treatment with vigabatrin had an electrical-clinical response in 5/16 patients, with the remaining cases responding to adrenocorticotropic hormone (ACTH). Almost half (44%) of the patients progressed to other types of epilepsy, with no difference between those treated with vigabatrin or ACTH. A greater number of adverse effects were obtained with ACTH, with no retinal involvement being observed with vigabatrin. The aetiological cause was found in 2/16. Being female, late onset, and early control of the hypsarrhythmia, were factors of a good prognosis. The overall prognosis of cryptogenic WS was more serious than expected. Although the incidence of Lennox-Gastaut syndrome was low, the progression to focal epilepsy was the most common, with it appearing within the first 2 years of the diagnosis. The initial response to vigabatrin was lower than expected, but the long-term result was comparable to ACTH. Copyright © 2017. Publicado por Elsevier España, S.L.U.

  7. The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials – A secondary analysis

    Directory of Open Access Journals (Sweden)

    Walach Harald

    2005-08-01

    Full Text Available Abstract Background and purpose Placebo response rates in clinical trials vary considerably and are observed frequently. For new drugs it can be difficult to prove effectiveness superior to placebo. It is unclear what contributes to improvement in the placebo groups. We wanted to clarify, what elements of clinical trials determine placebo variability. Methods We analysed a representative sample of 141 published long-term trials (randomized, double-blind, placebo-controlled; duration > 12 weeks to find out what study characteristics predict placebo response rates in various diseases. Correlational and regression analyses with study characteristics and placebo response rates were carried out. Results We found a high and significant correlation between placebo and treatment response rate across diseases (r = .78; p Conclusion Medication response rates and placebo response rates in clinical trials are highly correlated. Trial characteristics can explain some portion of the variance in placebo healing rates in RCTs. Placebo response in trials is only partially due to methodological artefacts and only partially dependent on the diagnoses treated.

  8. Immune and clinical response to honeybee venom in beekeepers

    Directory of Open Access Journals (Sweden)

    Jan Matysiak

    2016-03-01

    The differences in the immune response to a bee sting between the beekeepers and individuals not exposed to bees were probably due to the high exposure of the beekeepers to honeybee venom allergens. This may suggest a different approach to the bee venom allergy diagnostic tests in this occupational group.

  9. 'The Good Citizen’

    DEFF Research Database (Denmark)

    Offersen, Sara Marie Hebsgaard; Vedsted, Peter; Andersen, Rikke Sand

    2017-01-01

    the Danish welfare state and the middle-class popula- tion is embodied in a responsibility for individual health. Overall, we identify a striving to be a ‘good citizen’; this entails confl icting moral possibilities in relation to experiencing, interpreting and acting on bodily sensations. We examine how...

  10. Radiation-Induced Bystander Response: Mechanism and Clinical Implications

    Science.gov (United States)

    Suzuki, Keiji; Yamashita, Shunichi

    2014-01-01

    Significance: Absorption of energy from ionizing radiation (IR) to the genetic material in the cell gives rise to damage to DNA in a dose-dependent manner. There are two types of DNA damage; by a high dose (causing acute or deterministic effects) and by a low dose (related to chronic or stochastic effects), both of which induce different health effects. Among radiation effects, acute cutaneous radiation syndrome results from cell killing as a consequence of high-dose exposure. Recent advances: Recent advances in radiation biology and oncology have demonstrated that bystander effects, which are emerged in cells that have never been exposed, but neighboring irradiated cells, are also involved in radiation effects. Bystander effects are now recognized as an indispensable component of tissue response related to deleterious effects of IR. Critical issues: Evidence has indicated that nonapoptotic premature senescence is commonly observed in various tissues and organs. Senesced cells were found to secrete various proteins, including cytokines, chemokines, and growth factors, most of which are equivalent to those identified as bystander factors. Secreted factors could trigger cell proliferation, angiogenesis, cell migration, inflammatory response, etc., which provide a tissue microenvironment assisting tissue repair and remodeling. Future directions: Understandings of the mechanisms and physiological relevance of radiation-induced bystander effects are quite essential for the beneficial control of wound healing and care. Further studies should extend our knowledge of the mechanisms of bystander effects and mode of cell death in response to IR. PMID:24761341

  11. Using clinical supervision to improve the quality and safety of patient care: a response to Berwick and Francis.

    Science.gov (United States)

    Tomlinson, Jonathon

    2015-06-11

    After widely publicised investigations into excess patient deaths at Mid Staffordshire hospital the UK government commissioned reports from Robert Francis QC and Professor Don Berwick. Among their recommendations to improve the quality and safety of patient care were lifelong learning, professional support and 'just culture'. Clinical supervision is in an excellent position to support these activities but opportunities are in danger of being squeezed out by regulatory and managerial demands. Doctors who have completed their training are responsible for complex professional judgements for which narrative supervision is particularly helpful. With reference to the literature and my own practice I propose that all practicing clinicians should have regular clinical supervision. Clinical supervision has patient-safety and the quality of patient care as its primary purposes. After training is completed, doctors may practice for the rest of their career without any clinical supervision, the implication being that the difficulties dealt with in clinical supervision are no longer difficulties, or are better dealt with some other way. Clinical supervision is sufficiently flexible to be adapted to the needs of experienced clinicians as its forms can be varied, though its functions remain focused on patient safety, good quality clinical care and professional wellbeing. The evidence linking clinical supervision to the quality and safety of patient care reveals that supervision is most effective when its educational and supportive functions are separated from its managerial and evaluative functions. Among supervision's different forms, narrative-based-supervision is particularly useful as it has been developed for clinicians who have completed their training. It provides ways to explore the complexity of clinical judgements and encourages doctors to question one another's authority in a supportive culture. To be successful, supervision should also be professionally led and

  12. Clinical utility and validity of minoxidil response testing in androgenetic alopecia.

    Science.gov (United States)

    Goren, Andy; Shapiro, Jerry; Roberts, Janet; McCoy, John; Desai, Nisha; Zarrab, Zoulikha; Pietrzak, Aldona; Lotti, Torello

    2015-01-01

    Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3-6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA. © 2014 Wiley Periodicals, Inc.

  13. [Application of three compartment model and response surface model to clinical anesthesia using Microsoft Excel].

    Science.gov (United States)

    Abe, Eiji; Abe, Mari

    2011-08-01

    With the spread of total intravenous anesthesia, clinical pharmacology has become more important. We report Microsoft Excel file applying three compartment model and response surface model to clinical anesthesia. On the Microsoft Excel sheet, propofol, remifentanil and fentanyl effect-site concentrations are predicted (three compartment model), and probabilities of no response to prodding, shaking, surrogates of painful stimuli and laryngoscopy are calculated using predicted effect-site drug concentration. Time-dependent changes in these calculated values are shown graphically. Recent development in anesthetic drug interaction studies are remarkable, and its application to clinical anesthesia with this Excel file is simple and helpful for clinical anesthesia.

  14. Effect of an educational intervention in primary care physicians on the compliance of indicators of good clinical practice in the treatment of type 2 diabetes mellitus [OBTEDIGA project].

    Science.gov (United States)

    Vidal-Pardo, J I; Pérez-Castro, T R; López-Álvarez, X L; Santiago-Pérez, M I; García-Soidán, F J; Muñiz, J

    2013-08-01

    To evaluate the effect of an educational intervention among primary care physicians on several indicators of good clinical practice in diabetes care. Two groups of physicians were randomly assigned to the intervention or control group (IG and CG). Every physician randomly selected two samples of patients from all type 2 diabetic patients aged 40 years and above and diagnosed more than a year ago. Baseline and final information were collected cross-sectionally 12 months apart, in two independent samples of 30 patients per physician. The educational intervention comprised: distribution of educational materials and physicians' specific bench-marking information, an on-line course and three on-site educational workshops on diabetes. External observers collected information directly from the physicians and from the medical records of the patients on personal and family history of disease and on the evolution and treatment of their disease. Baseline information was collected retrospectively in the control group. Intervention group comprised 53 physicians who included a total of 3018 patients in the baseline and final evaluations. CG comprised 50 physicians who included 2868 patients in the same evaluations. Measurement of micro-albuminuria in the last 12 months (OR = 1.6, 95% CI: 1.1-2.4) and foot examination in the last year (OR = 2.0, 95% CI: 1.1-3.6) were the indicators for which greater improvement was found in the IG. No other indicator considered showed statistically significant improvement between groups. The identification of indicators with very low level of compliance and the implementation of a simple intervention in physicians to correct them is effective in improving the quality of care of diabetic patients. © 2013 John Wiley & Sons Ltd.

  15. Clinical Response to Ingenol Mebutate in Patients With Actinic Keratoses.

    Science.gov (United States)

    Batalla, A; Flórez, Á; Feal, C; Peón, G; Abalde, M T; Salgado-Boquete, L; de la Torre, C

    2015-12-01

    Cryotherapy is the most common treatment for actinic keratosis, but its effect is limited to individual lesions. Several topical drugs, however, are available that, in addition to treating individual actinic keratoses, target field cancerization and thereby act on subclinical lesions. Examples are 5-fluorouracil, imiquimod, diclofenac, and ingenol mebutate. We report on 17 patients with actinic keratoses treated with ingenol mebutate and describe our findings on treatment effectiveness, adherence, and tolerance. Complete and partial response rates were 35% and 53%, respectively. Ninety-four percent of patients fully adhered to treatment and 18% developed severe local reactions. Ingenol mebutate is an effective treatment for actinic keratosis. Although it has a similar rate of local reactions to other treatments available for actinic keratosis, its short treatment regimen favors better adherence. Copyright © 2014 Elsevier España, S.L.U. y AEDV. All rights reserved.

  16. Shame, honor and responsibility in clinical dialog about lifestyle issues

    DEFF Research Database (Denmark)

    Guassora, A.D.; Reventlow, S.; Malterud, K.

    2014-01-01

    OBJECTIVE: To explore how patients enact presentations of self in consultations dealing with lifestyle in general practice. METHODS: We conducted a qualitative observational study with thematic, cross-case analysis of video-recorded consultations inspired by discourse analysis. RESULTS: Patients ....... Failure to do so could lead to distance and hostility while a strategy to acknowledge the impact of shame could help develop and strengthen the doctor-patient relationship.......OBJECTIVE: To explore how patients enact presentations of self in consultations dealing with lifestyle in general practice. METHODS: We conducted a qualitative observational study with thematic, cross-case analysis of video-recorded consultations inspired by discourse analysis. RESULTS: Patients...... patients shifted attention to another, of which they were more proud. In areas where they were not doing well, some patients revealed shame for not acting responsibly. In such cases, patients spoke of themselves in terms of self-deprecation or admitted not living up to expected standards. CONCLUSION...

  17. Roles and Responsibilities, and Education and Training Requirements for Clinically Qualified Medical Physicists (Russian Edition)

    International Nuclear Information System (INIS)

    2014-01-01

    This publication addresses the shortfall of well trained and clinically qualified medical physicists working in radiation medicine. The roles, responsibilities and clinical training requirements of medical physicists have not always been well defined or well understood by health care professionals, health authorities and regulatory agencies. To fill this gap, this publication provides recommendations for the academic education and clinical training of clinically qualified medical physicists, including recommendations for their accreditation certification and registration, along with continuous professional development. The goal is to establish criteria that support the harmonization of education and clinical training worldwide

  18. The OnyCOE-t™ questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis

    Directory of Open Access Journals (Sweden)

    Kianifard Farid

    2006-08-01

    Full Text Available Abstract Background This research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t™, a questionnaire specifically designed to measure patient-reported outcomes (PRO associated with toenail onychomycosis. Methods 504 patients with toenail onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or without target toenail debridement in the IRON-CLAD® trial completed the OnyCOE-t™ at baseline, weeks 6, 12, 24, and 48. The OnyCOE-t™ is composed of 6 multi-item scales and 1 single-item scale. These include a 7-item Toenail Symptom assessment, which comprises both Symptom Frequency and Symptom Bothersomeness scales; an 8-item Appearance Problems scale; a 7-item Physical Activities Problems scale; a 1-item Overall Problem scale; a 7-item Stigma scale; and a 3-item Treatment Satisfaction scale. In total, 33 toenail onychomycosis-specific items are included in the OnyCOE-t™. Clinical data, in particular the percent clearing of mycotic involvement in the target toenail, and OnyCOE-t™ responses were used to evaluate the questionnaire's reliability, validity, responsiveness, and the minimally clinical important difference (MCID. Results The OnyCOE-t™ was shown to be reliable and valid. Construct validity and known groups validity were acceptable. Internal consistency reliability of multi-item scales was demonstrated by Cronbach's alpha > .84. Responsiveness was good, with the Treatment Satisfaction, Symptom Frequency, Overall Problem, and Appearance Problem scales demonstrating the most responsiveness (Guyatt's statistic of 1.72, 1.31, 1.13, and 1.11, respectively. MCID was evaluated for three different clinical measures, and indicated that approximately an 8.5-point change (on a 0 to 100 scale was clinically meaningful based on a 25% improvement in target nail clearing. Conclusion The OnyCOE-t™ questionnaire is a unique, toenail-specific PRO

  19. Response

    Science.gov (United States)

    Higgins, Chris

    2012-01-01

    This article presents the author's response to the reviews of his book, "The Good Life of Teaching: An Ethics of Professional Practice." He begins by highlighting some of the main concerns of his book. He then offers a brief response, doing his best to address the main criticisms of his argument and noting where the four reviewers (Charlene…

  20. Abusing Good Intentions

    Directory of Open Access Journals (Sweden)

    Tamas Bereczkei

    2015-06-01

    Full Text Available The present study aims to understand how Machiavellians switch from one kind of response to another in different circumstances to maximize their profit. We set up a specific experimental paradigm that involved both a cooperative and competitive version of a public goods game. We found that Machiavellianism accounts for the total amount of money paid by the players (N = 144 across five rounds in the cooperative but not in the competitive game. Compared with the others, individuals with higher scores on Mach scale contributed less to the public goods in the cooperative condition, but no difference was found in the competitive condition. Finally, this relationship was influenced by the sequence of the games. These results indicate that Machiavellians skillfully evaluate social environments and strive to exploit those with abundant contributions to public goods.

  1. Clinical, pathological and functional characterization of riboflavin-responsive neuropathy.

    Science.gov (United States)

    Manole, Andreea; Jaunmuktane, Zane; Hargreaves, Iain; Ludtmann, Marthe H R; Salpietro, Vincenzo; Bello, Oscar D; Pope, Simon; Pandraud, Amelie; Horga, Alejandro; Scalco, Renata S; Li, Abi; Ashokkumar, Balasubramaniem; Lourenço, Charles M; Heales, Simon; Horvath, Rita; Chinnery, Patrick F; Toro, Camilo; Singleton, Andrew B; Jacques, Thomas S; Abramov, Andrey Y; Muntoni, Francesco; Hanna, Michael G; Reilly, Mary M; Revesz, Tamas; Kullmann, Dimitri M; Jepson, James E C; Houlden, Henry

    2017-11-01

    Drosophila also resulted in severely impaired locomotor activity and reduced lifespan, mirroring patient pathology, and these phenotypes could be partially rescued using a novel esterified derivative of riboflavin. Our findings expand the genetic, clinical and neuropathological features of Brown-Vialetto-Van Laere syndrome, implicate mitochondrial dysfunction as a downstream consequence of riboflavin transporter gene defects, and validate riboflavin esters as a potential therapeutic strategy. © The Author (2017). Published by Oxford University Press on behalf of the Guarantors of Brain.

  2. SUCCESSFUL USE OF ETANERCEPT IN A PATIENT WITH POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS WITH AN OVERVIEW OF THE PREDICTORS OF A GOOD RESPONSE TO ONGOING THERAPY

    Directory of Open Access Journals (Sweden)

    Anna V. Karaseva

    2017-01-01

    Full Text Available The  article  presents  a case  of  polyarticular  juvenile  idiopathic  arthritis  resistant  to  methotrexate  therapy  and  nonsteroidal  antiinflammatory drugs.  The child was prescribed  a tumor necrosis  factor   inhibitor etanercept  at a dose  of 0.4 mg/kg body weight2 times/week. The treatment  with etanercept  induced remission of the disease, ensured the function restoration  in the joints. The predictors  of a good response  to etanercept  were the younger  age, the short  course  of the disease,  the use of a small number of immunosuppressants  before prescription of etanercept, the absence of concomitant use of glucocorticosteroids,  and the absence of uveitis.

  3. Rebuttal to Nelson et al. 'Response to Bodin and Grote regarding postdoctoral recruitment in clinical neuropsychology'.

    Science.gov (United States)

    Bodin, Doug; Grote, Christopher L

    2016-07-01

    Nelson et al. provided a response to our commentary on the postdoctoral match in clinical neuropsychology. In this brief rebuttal, we will focus on statements from Nelson et al. that we believe are factual inaccuracies or misunderstandings of some of the points we made in our commentary. In addition, we will comment briefly on the proposed guidelines offered in their response.

  4. Seronegative and seropositive autoimmune autonomic ganglionopathy (AAG): Same clinical picture, same response to immunotherapy.

    Science.gov (United States)

    Tijero, Beatriz; Del Pino, Rocio; Pérez-Concha, Tomás; Acera, Maria Angeles; Gabilondo, Iñigo; Berganzo, Koldo; Graus, Frances; Martinez-Alday, Jesus Daniel; Barcena, Joseba; Gómez-Esteban, Juan Carlos

    2018-06-15

    Two patients with a syndrome of pandisautonomia with clinical criteria of AAG are provided. Both patients present a similar clinical picture and response to immunosuppressive treatment. One of them has positive antibodies against the ganglionic nicotinic acetylcholine (gAChr) and the other does not. This brief article serves to reflect the spectrum of AAG, at a clinical level, in laboratory tests and in the response to immunotherapy, independently of the presence of positive gAChr antibodies. Copyright © 2018 Elsevier B.V. All rights reserved.

  5. Hospital in the Home nurses' recognition and response to clinical deterioration.

    Science.gov (United States)

    Gray, Erika; Currey, Judy; Considine, Julie

    2018-05-01

    To obtain an understanding of how Hospital in the Home (HITH) nurses recognise and respond to clinical deterioration in patients receiving care at home or in their usual place of residence. Recognising and responding to clinical deterioration is an international safety priority and a key nursing responsibility. Despite an increase in care delivery in home environments, how HITH nurses recognise and respond to clinical deterioration is not yet fully understood. A prospective, descriptive exploratory design was used. A survey containing questions related to participant characteristics and 10 patient scenarios was used to collect data from 47 nurses employed in the HITH units of three major health services in Melbourne, Australia. The 10 scenarios reflected typical HITH patients and included medical history and clinical assessment findings (respiratory rate, oxygen saturation, heart rate, blood pressure, temperature, conscious state and pain score). The three major findings from this study were that: (i) nurse and patient characteristics influenced HITH nurses' assessment decisions; (ii) the cues used by HITH nurses to recognise clinical deterioration varied according to the clinical context; and (iii) although HITH nurses work in an autonomous role, they engage in collaborative practice when responding to clinical deterioration. Hospital in the Home nurses play a fundamental role in patient assessment, and the context in which they recognise and respond to deterioration is markedly different to that of hospital nurses. The assessment, measurement and interpretation of clinical data are a nursing responsibility that is crucial to early recognition and response to clinical deterioration. The capacity of HITH services to care for increasing numbers of patients in their home environment, and to promptly recognise and respond to clinical deterioration should it occur, is fundamental to safety within the healthcare system. Hospital in the Home nurses are integral to a

  6. Clinical predictors of acute response to transcranial direct current stimulation (tDCS) in major depression.

    Science.gov (United States)

    D'Urso, Giordano; Dell'Osso, Bernardo; Rossi, Rodolfo; Brunoni, Andre Russowsky; Bortolomasi, Marco; Ferrucci, Roberta; Priori, Alberto; de Bartolomeis, Andrea; Altamura, Alfredo Carlo

    2017-09-01

    Transcranial direct current stimulation (tDCS) is a promising neuromodulation intervention for poor-responding or refractory depressed patients. However, little is known about predictors of response to this therapy. The present study aimed to analyze clinical predictors of response to tDCS in depressed patients. Clinical data from 3 independent tDCS trials on 171 depressed patients (including unipolar and bipolar depression), were pooled and analyzed to assess predictors of response. Depression severity and the underlying clinical dimensions were measured using the Hamilton Depression Rating Scale (HDRS) at baseline and after the tDCS treatment. Age, gender and diagnosis (bipolar/unipolar depression) were also investigated as predictors of response. Linear mixed models were fitted in order to ascertain which HDRS factors were associated with response to tDCS. Age, gender and diagnosis did not show any association with response to treatment. The reduction in HDRS scores after tDCS was strongly associated with the baseline values of "Cognitive Disturbances" and "Retardation" factors, whilst the "Anxiety/Somatization" factor showed a mild association with the response. Open-label design, the lack of control group, and minor differences in stimulation protocols. No differences in response to tDCS were found between unipolar and bipolar patients, suggesting that tDCS is effective for both conditions. "Cognitive disturbance", "Retardation", and "Anxiety/Somatization", were identified as potential clinical predictors of response to tDCS. These findings point to the pre-selection of the potential responders to tDCS, therefore optimizing the clinical use of this technique and the overall cost-effectiveness of the psychiatric intervention for depressed patients. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Patients' Positive and Negative Responses to Reading Mental Health Clinical Notes Online.

    Science.gov (United States)

    Denneson, Lauren M; Chen, Jason I; Pisciotta, Maura; Tuepker, Anais; Dobscha, Steven K

    2018-05-01

    This study describes responses to OpenNotes, clinical notes available online, among patients receiving mental health care and explores whether responses vary by patient demographic or clinical characteristics. Survey data from 178 veterans receiving mental health treatment at a large Veterans Affairs medical center included patient-reported health self-efficacy, health knowledge, alliance with clinicians, and negative emotional responses after reading OpenNotes. Health care data were extracted from the patient care database. Reading OpenNotes helped many participants feel in control of their health care (49%) and have more trust in clinicians (45%), although a few (8%) frequently felt upset after reading their notes. In multivariate models, posttraumatic stress disorder was associated with increased patient-clinician alliance (p=.046) but also with negative emotional responses (p<.01). Patients receiving mental health care frequently reported benefits from reading OpenNotes, yet some experienced negative responses.

  8. GOOD GOVERNANCE AND TRANSFORMATION

    Directory of Open Access Journals (Sweden)

    Hans-Jürgen WAGENER

    2005-12-01

    Full Text Available Transformation of a totalitarian, basically administratively coordinated system into a democratic one that is coordinated predominantly by markets and competition has been triggered by, among others, the perception of a serious deficit in welfare and happiness. Public policy has a special task transforming the economic order by liberalisation, privatisation, stabilisation and the installation of institutions that are supportive for competition. After 15 years since transformation began, there are sufficiently differentiated success stories to test the hypothesis: it was good governance that is responsible for success and bad governance for failure. The empirical results support the “Lorenzetti hypothesis”: where freedom, security and trust prevail, the economy flourishes, where they are lacking, the costs of long-term investment are too high. The initial conditions of transition countries seem to be quite similar, nevertheless, even there one can discern good and bad governance. The extent of socialist lawfulness, planning security, cronyism and corruption differed widely between East Berlin and Tashkent. And a good deal of such variations can be found in the pre-socialist history of these countries. However, the main conclusion is that the co-evolution hypothesis states that both, welfare and good governance, go together.

  9. Regenerative medicine and responsible research and innovation: proposals for a responsible acceleration to the clinic.

    Science.gov (United States)

    Webster, Andrew

    2017-10-01

    This paper asks how regenerative medicine can be examined through the 'responsible research and innovation' (RRI) approach which has been developed over the past decade. It describes the drivers to the development of RRI, and then argues for the need to understand innovation itself through drawing on social science analysis rooted in science and technology studies. The paper then identifies a number of highly specific challenges faced by the regenerative medicine field and the implications these have for value creation. It offers a number of examples of how a combined RRI/science and technology studies perspective can identify priority areas for policy and concludes by arguing for a 'responsible acceleration', more likely to foster readiness at a time when much of the policy domain is pushing for ever-rapid access to cell therapies.

  10. Clinical factors of response in patients with advanced ovarian cancer participating in early phase clinical trials.

    Science.gov (United States)

    George, Angela; Kristeleit, Rebecca; Rafii, Saeed; Michie, Caroline O; Bowen, Rebecca; Michalarea, Vasiliki; van Hagen, Tom; Wong, Mabel; Rallis, Grigorios; Molife, L Rhoda; Lopez, Juanita; Banerji, Udai; Banerjee, Susana N; Gore, Martin E; de Bono, Johann S; Kaye, Stan B; Yap, Timothy A

    2017-05-01

    Drug resistance to conventional anticancer therapies is almost inevitable in patients with advanced ovarian cancer (AOC), limiting their available treatment options. Novel phase I trial therapies within a dedicated drug development unit may represent a viable alternative; however, there is currently little evidence for patient outcomes in such patients. To address this, we undertook a retrospective review of patients with AOC allocated to phase I trials in the Drug Development Unit at Royal Marsden Hospital (RMH) between June 1998 and October 2010. A total of 200 AOC patients with progressive disease were allocated to ≥1 trial each, with a total of 281 allocations. Of these, 135 (68%) patients commenced ≥1 trial (mean 1.4 [1-8]), totaling 216 allocated trials; 65 (32%) patients did not start due to deterioration resulting from rapidly progressive disease (63 patients) or patient choice (2 patients). Response Evaluation Criteria in Solid Tumours (RECIST) complete/partial responses (CR/PR) were observed in 43 (20%) of those starting trials, including those on poly(ADP-ribose) polymerase (PARP) inhibitors (18/79 [23%]), antiangiogenics (9/65 [14%]) and chemotherapy combinations (14/43 [33%]). Factors associated with CR/PR included: fewer prior treatments, platinum-sensitive disease, CR/PR with prior therapy, (the United States-based) Eastern Cooperative Oncology Group (ECOG) performance status score, fewer metastatic sites, higher albumin and haemoglobin levels, lower white cell counts and baseline CA125 levels, germline BRCA1/2 mutations and better RMH Prognostic Score. Mean survival was 32° months for patients who achieved CR/PR. Treatments were generally well tolerated. Most patients with AOC (134/200 [67%]) received ≥1 subsequent line of therapy after phase I trials. Our data suggest that phase I trial referrals should be considered earlier in the AOC treatment pathway and before the onset of rapid disease progression particularly with the emergence of

  11. A good day's work.

    Science.gov (United States)

    Bruck, F A

    2001-10-01

    Lowell's poorly executed supervisor/employee interaction was a lose-lose proposition. If other employees feel that Sue is being treated unfairly, there will be negative repercussions throughout the system. Employees must have confidence that they will be treated in a fair and equal manner when they have problems on the job. If management is not consistent in handling these problems, employees will spend time second-guessing critical decisions, and patient care will suffer. Sue and Dunk did a good job with their clinical care of Maudie. With improved patient communication, Maudie might have understood the reasons for her treatment, and this complaint might never have been made.

  12. Clinicians' emotional responses and Psychodynamic Diagnostic Manual adult personality disorders: A clinically relevant empirical investigation.

    Science.gov (United States)

    Gazzillo, Francesco; Lingiardi, Vittorio; Del Corno, Franco; Genova, Federica; Bornstein, Robert F; Gordon, Robert M; McWilliams, Nancy

    2015-06-01

    The aim of this study is to explore the relationship between level of personality organization and type of personality disorder as assessed with the categories in the Psychodynamic Diagnostic Manual (PDM; PDM Task Force, 2006) and the emotional responses of treating clinicians. We asked 148 Italian clinicians to assess 1 of their adult patients in treatment for personality disorders with the Psychodiagnostic Chart (PDC; Gordon & Bornstein, 2012) and the Personality Diagnostic Prototype (PDP; Gazzillo, Lingiardi, & Del Corno, 2012) and to complete the Therapist Response Questionnaire (TRQ; Betan, Heim, Zittel-Conklin, & Westen, 2005). The patients' level of overall personality pathology was positively associated with helpless and overwhelmed responses in clinicians and negatively associated with positive emotional responses. A parental and disengaged response was associated with the depressive, anxious, and dependent personality disorders; an exclusively parental response with the phobic personality disorder; and a parental and criticized response with narcissistic disorder. Dissociative disorder evoked a helpless and parental response in the treating clinicians whereas somatizing disorder elicited a disengaged reaction. An overwhelmed and disengaged response was associated with sadistic and masochistic personality disorders, with the latter also associated with a parental and hostile/criticized reaction; an exclusively overwhelmed response with psychopathic patients; and a helpless response with paranoid patients. Finally, patients with histrionic personality disorder evoked an overwhelmed and sexualized response in their clinicians whereas there was no specific emotional reaction associated with the schizoid and the obsessive-compulsive disorders. Clinical implications of these findings were discussed. (c) 2015 APA, all rights reserved).

  13. Protracted Hypofractionated Radiotherapy for Graves' Ophthalmopathy: A Pilot Study of Clinical and Radiologic Response

    Energy Technology Data Exchange (ETDEWEB)

    Casimiro de Deus Cardoso, Cejana; Giordani, Adelmo Jose [Department of Clinical and Experimental Oncology, Division of Radiotherapy, Federal University of Sao Paulo, Sao Paulo, SP (Brazil); Borri Wolosker, Angela Maria [Department of Radiology, Federal University of Sao Paulo, Sao Paulo, SP (Brazil); Souhami, Luis [Department of Radiotherapy, McGill University Heath Centre, Montreal, Quebec (Canada); Gois Manso, Paulo [Department of Ophthalmology, Federal University of Sao Paulo, Sao Paulo, SP (Brazil); Souza Dias, Rodrigo; Comodo Segreto, Helena Regina [Department of Clinical and Experimental Oncology, Division of Radiotherapy, Federal University of Sao Paulo, Sao Paulo, SP (Brazil); Araujo Segreto, Roberto, E-mail: segreto.dmed@epm.br [Department of Clinical and Experimental Oncology, Division of Radiotherapy, Federal University of Sao Paulo, Sao Paulo, SP (Brazil)

    2012-03-01

    Purpose: To evaluate the clinical and radiologic response of patients with Graves' ophthalmopathy given low-dose orbital radiotherapy (RT) with a protracted fractionation. Methods and Materials: Eighteen patients (36 orbits) received orbital RT with a total dose of 10 Gy, fractionated in 1 Gy once a week over 10 weeks. Of these, 9 patients received steroid therapy as well. Patients were evaluated clinically and radiologically at 6 months after treatment. Clinical response assessment was carried out using three criteria: by physical examination, by a modified clinical activity score, and by a verbal questionnaire considering the 10 most common signs and symptoms of the disease. Radiologic response was assessed by magnetic resonance imaging. Results: Improvement in ocular pain, palpebral edema, visual acuity, and ocular motility was observed in all patients. Significant decrease in symptoms such as tearing (p < 0.001) diplopia (p = 0.008), conjunctival hyperemia (p = 0.002), and ocular grittiness (p = 0.031) also occurred. Magnetic resonance imaging showed decrease in ocular muscle thickness and in the intensity of the T2 sequence signal in the majority of patients. Treatments were well tolerated, and to date no complications from treatment have been observed. There was no statistical difference in clinical and radiologic response between patients receiving RT alone and those receiving RT plus steroid therapy. Conclusion: RT delivered in at a low dose and in a protracted scheme should be considered as a useful therapeutic option for patients with Graves' ophthalmopathy.

  14. A novel approach to measuring response and remission in schizophrenia in clinical trials.

    Science.gov (United States)

    Aboraya, Ahmed; Leucht, Stefan; Nasrallah, Henry A; Samara, Myrto; Haro, Josep Maria; Elshazly, Ahmed; Zangeneh, Masood

    2017-12-01

    Pharmaceutical companies conduct clinical trials to show the efficacy and safety of new medications for the treatment of schizophrenia. After the new medications are marketed, clinicians treating patients with schizophrenia discover that a considerable number of patients do not respond to these new medications. The goals of the review are to examine the methodology and design of recent antipsychotic clinical trials, identify common flaws, and propose guidelines to fix the flaws and improve the quality of future clinical trials of antipsychotic medications. A review of recent antipsychotic clinical trials was conducted using a PubMed search. Ten recent trials published in the past four years were reviewed and their methods analyzed and critiqued. The authors identified six major methodological flaws that may explain the suboptimal response in many patients after a drug is approved. Most of the flaws are related to eligibility criteria, the misuse of the Positive and Negative Syndromes Scale (PANSS) and the lack of consensus on how to define remission, response and exacerbation in schizophrenia. Proposed guidelines for a more rigorous use of the PANSS are presented and recommendations are proposed for using uniform criteria for remission, response and exacerbation in schizophrenia. The authors recommend using standardized diagnostic interviews to screen patients for eligibility criteria and using the PANSS according to the author's recommendations and the proposed guidelines. Uniform criteria to define remission, response and exacerbation are recommended for clinical trials examining the efficacy and safety of antipsychotic drugs in schizophrenia. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Use of Portable Digital Devices to Analyze Autonomic Stress Response in Psychology Objective Structured Clinical Examination.

    Science.gov (United States)

    Beltrán-Velasco, Ana Isabel; Bellido-Esteban, Alberto; Ruisoto-Palomera, Pablo; Clemente-Suárez, Vicente Javier

    2018-01-12

    The aim of the present study was to explore changes in the autonomic stress response of Psychology students in a Psychology Objective Structured Clinical Examination (OSCE) and their relationship with OSCE performance. Variables of autonomic modulation by the analysis of heart rate variability in temporal, frequency and non-linear domains, subjective perception of distress strait and academic performance were measured before and after the two different evaluations that composed the OSCE. A psychology objective structured clinical examination composed by two different evaluation scenarios produced a large anxiety anticipatory response, a habituation response in the first of the evaluation scenarios and a in the entire evaluation, and a no habituation response in the second evaluation scenario. Autonomic modulation parameters do not correlate with academic performance of students.

  16. Pharmacogenomics of Methotrexate Membrane Transport Pathway: Can Clinical Response to Methotrexate in Rheumatoid Arthritis Be Predicted?

    Directory of Open Access Journals (Sweden)

    Aurea Lima

    2015-06-01

    Full Text Available Background: Methotrexate (MTX is widely used for rheumatoid arthritis (RA treatment. Single nucleotide polymorphisms (SNPs could be used as predictors of patients’ therapeutic outcome variability. Therefore, this study aims to evaluate the influence of SNPs in genes encoding for MTX membrane transport proteins in order to predict clinical response to MTX. Methods: Clinicopathological data from 233 RA patients treated with MTX were collected, clinical response defined, and patients genotyped for 23 SNPs. Genotype and haplotype analyses were performed using multivariate methods and a genetic risk index (GRI for non-response was created. Results: Increased risk for non-response was associated to SLC22A11 rs11231809 T carriers; ABCC1 rs246240 G carriers; ABCC1 rs3784864 G carriers; CGG haplotype for ABCC1 rs35592, rs2074087 and rs3784864; and CGG haplotype for ABCC1 rs35592, rs246240 and rs3784864. GRI demonstrated that patients with Index 3 were 16-fold more likely to be non-responders than those with Index 1. Conclusions: This study revealed that SLC22A11 and ABCC1 may be important to identify those patients who will not benefit from MTX treatment, highlighting the relevance in translating these results to clinical practice. However, further validation by independent studies is needed to develop the field of personalized medicine to predict clinical response to MTX treatment.

  17. Typhoid fever in young children in Bangladesh: clinical findings, antibiotic susceptibility pattern and immune responses.

    Directory of Open Access Journals (Sweden)

    Farhana Khanam

    2015-04-01

    Full Text Available Children bear a large burden of typhoid fever caused by Salmonella enterica serotype Typhi (S. Typhi in endemic areas. However, immune responses and clinical findings in children are not well defined. Here, we describe clinical and immunological characteristics of young children with S. Typhi bacteremia, and antimicrobial susceptibility patterns of isolated strains.As a marker of recent infection, we have previously characterized antibody-in-lymphocyte secretion (TPTest during acute typhoid fever in adults. We similarly assessed membrane preparation (MP IgA responses in young children at clinical presentation, and then 7-10 days and 21-28 days later. We also assessed plasma IgA, IgG and IgM responses and T cell proliferation responses to MP at these time points. We compared responses in young children (1-5 years with those seen in older children (6-17 years, adults (18-59 years, and age-matched healthy controls.We found that, compared to age-matched controls patients in all age cohorts had significantly more MP-IgA responses in lymphocyte secretion at clinical presentation, and the values fell in all groups by late convalescence. Similarly, plasma IgA responses in patients were elevated at presentation compared to controls, with acute and convalescent IgA and IgG responses being highest in adults. T cell proliferative responses increased in all age cohorts by late convalescence. Clinical characteristics were similar in all age cohorts, although younger children were more likely to present with loss of appetite, less likely to complain of headache compared to older cohorts, and adults were more likely to have ingested antibiotics. Multi-drug resistant strains were present in approximately 15% of each age cohort, and 97% strains had resistance to nalidixic acid.This study demonstrates that S. Typhi bacteremia is associated with comparable clinical courses, immunologic responses in various age cohorts, including in young children, and that TPTest

  18. Quantification of clinical scores through physiological recordings in low-responsive patients: a feasibility study

    Directory of Open Access Journals (Sweden)

    Wieser Martin

    2012-05-01

    Full Text Available Abstract Clinical scores represent the gold standard in characterizing the clinical condition of patients in vegetative or minimally conscious state. However, they suffer from problems of sensitivity, specificity, subjectivity and inter-rater reliability. In this feasibility study, objective measures including physiological and neurophysiological signals are used to quantify the clinical state of 13 low-responsive patients. A linear regression method was applied in nine patients to obtain fixed regression coefficients for the description of the clinical state. The statistical model was extended and evaluated with four patients of another hospital. A linear mixed models approach was introduced to handle the challenges of data sets obtained from different locations. Using linear backward regression 12 variables were sufficient to explain 74.4% of the variability in the change of the clinical scores. Variables based on event-related potentials and electrocardiogram account for most of the variability. These preliminary results are promising considering that this is the first attempt to describe the clinical state of low-responsive patients in such a global and quantitative way. This new model could complement the clinical scores based on objective measurements in order to increase diagnostic reliability. Nevertheless, more patients are necessary to prove the conclusions of a statistical model with 12 variables.

  19. Bladder cancer treatment response assessment with radiomic, clinical, and radiologist semantic features

    Science.gov (United States)

    Gordon, Marshall N.; Cha, Kenny H.; Hadjiiski, Lubomir M.; Chan, Heang-Ping; Cohan, Richard H.; Caoili, Elaine M.; Paramagul, Chintana; Alva, Ajjai; Weizer, Alon Z.

    2018-02-01

    We are developing a decision support system for assisting clinicians in assessment of response to neoadjuvant chemotherapy for bladder cancer. Accurate treatment response assessment is crucial for identifying responders and improving quality of life for non-responders. An objective machine learning decision support system may help reduce variability and inaccuracy in treatment response assessment. We developed a predictive model to assess the likelihood that a patient will respond based on image and clinical features. With IRB approval, we retrospectively collected a data set of pre- and post- treatment CT scans along with clinical information from surgical pathology from 98 patients. A linear discriminant analysis (LDA) classifier was used to predict the likelihood that a patient would respond to treatment based on radiomic features extracted from CT urography (CTU), a radiologist's semantic feature, and a clinical feature extracted from surgical and pathology reports. The classification accuracy was evaluated using the area under the ROC curve (AUC) with a leave-one-case-out cross validation. The classification accuracy was compared for the systems based on radiomic features, clinical feature, and radiologist's semantic feature. For the system based on only radiomic features the AUC was 0.75. With the addition of clinical information from examination under anesthesia (EUA) the AUC was improved to 0.78. Our study demonstrated the potential of designing a decision support system to assist in treatment response assessment. The combination of clinical features, radiologist semantic features and CTU radiomic features improved the performance of the classifier and the accuracy of treatment response assessment.

  20. The role of clinical variables, neuropsychological performance and SLC6A4 and COMT gene polymorphisms on the prediction of early response to fluoxetine in major depressive disorder.

    Science.gov (United States)

    Gudayol-Ferré, Esteve; Herrera-Guzmán, Ixchel; Camarena, Beatriz; Cortés-Penagos, Carlos; Herrera-Abarca, Jorge E; Martínez-Medina, Patricia; Cruz, David; Hernández, Sandra; Genis, Alma; Carrillo-Guerrero, Mariana Y; Avilés Reyes, Rubén; Guàrdia-Olmos, Joan

    2010-12-01

    Major depressive disorder (MDD) is treated with antidepressants, but only between 50% and 70% of the patients respond to the initial treatment. Several authors suggested different factors that could predict antidepressant response, including clinical, psychophysiological, neuropsychological, neuroimaging, and genetic variables. However, these different predictors present poor prognostic sensitivity and specificity by themselves. The aim of our work is to study the possible role of clinical variables, neuropsychological performance, and the 5HTTLPR, rs25531, and val108/58Met COMT polymorphisms in the prediction of the response to fluoxetine after 4weeks of treatment in a sample of patient with MDD. 64 patients with MDD were genotyped according to the above-mentioned polymorphisms, and were clinically and neuropsychologically assessed before a 4-week fluoxetine treatment. Fluoxetine response was assessed by using the Hamilton Depression Rating Scale. We carried out a binary logistic regression model for the potential predictive variables. Out of the clinical variables studied, only the number of anxiety disorders comorbid with MDD have predicted a poor response to the treatment. A combination of a good performance in variables of attention and low performance in planning could predict a good response to fluoxetine in patients with MDD. None of the genetic variables studied had predictive value in our model. The possible placebo effect has not been controlled. Our study is focused on response prediction but not in remission prediction. Our work suggests that the combination of the number of comorbid anxiety disorders, an attentional variable, and two planning variables makes it possible to correctly classify 82% of the depressed patients who responded to the treatment with fluoxetine, and 74% of the patients who did not respond to that treatment. Copyright © 2010 Elsevier B.V. All rights reserved.

  1. Developmental trajectories of infants and toddlers with good initial presentation following moderate or severe traumatic brain injury: a pilot clinical assessment project.

    Science.gov (United States)

    Pomerleau, Geneviève; Hurteau, Anne-Marie; Parent, Line; Doucet, Katrine; Corbin-Berrigan, Laurie-Ann; Gagnon, Isabelle

    2012-01-01

    The purpose of this study was to review the feasibility and usefulness of instituting a clinical protocol of scheduled assessments for children after a moderate or severe traumatic brain injury (TBI) sustained before the age of 2 years and showing no immediate deficits at hospital discharge, as well as to explore the early developmental trajectories of these children. Exploratory analytical cohort study. Pediatric Trauma Center Out-patient services. 31 children were followed within the clinical protocol of scheduled assessments. The protocol included an immediate post-injury clinical assessment of infants who sustained a TBI and follow-up assessments at the ages of 9 months, 18 months (if injured prior to that age), 30 months, and 42 months. Domains assessed at each scheduled visit included hearing, speech and language, motor performance, personal social abilities, and adaptive behaviors. Clinicians reported few difficulties with scheduling or administering the assessments, maintaining a 67% participation rate at the end of the follow-up period, thus demonstrating the feasibility of the protocol in this population. Scores on the majority of formal tests showed high variability and 15-20% of children presented with clinically significant motor and/or language delays. By 42 months of age, difficulties with adaptive behavior and personal social abilities were identified in our sample of children when compared to published norms. Qualitative clinical findings from professionals identified between 25-50% of children with potential attentional difficulties throughout the follow-up period. Findings from this study demonstrate the feasibility of implementing a clinical protocol of assessment for infants and toddlers who sustain a TBI before the age of 2 years and present with no impairments at the time of discharge from hospital. Developmental problems in this population appear to be easier to identify later in the toddler years as opposed to immediately following the TBI

  2. Clinical Outcome of Patients with Complete Pathological Response to Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancers: The Indian Scenario

    Directory of Open Access Journals (Sweden)

    Snita Sinukumar

    2014-01-01

    Full Text Available Introduction. Neoadjuvant chemoradiotherapy and total mesorectal excision are considered the standard treatment for locally advanced rectal cancer. Various studies have reported pathological downstaging and a complete pathological response rate of 15%–27% following neoadjuvant chemoradiotherapy which has translated into improved survival. We endeavour to determine the clinical outcome of patients attaining a complete pathological tumor response following neoadjuvant chemoradiotherapy in the Indian setting where most of our patient population is younger and presents with aggressive tumor biology. Materials and Methods. Clinicopathological and treatment details were recorded for 64 patients achieving pathological complete response from 2010 to 2013. Disease-free survival (DFS, overall survival (OS, and locoregional and systemic recurrence rates were evaluated for these patients. Results. After a median follow-up of 30.5 months (range 11–59 months, the 3-year overall survival (OS was 94.6% and the 3-year disease-free survival (DFS was 88.5%. The locoregional and systemic recurrence rates were 4.7% and 3.1%, respectively. Conclusion. In the Indian subcontinent, despite younger patients with aggressive tumor biology, outcome in complete responders is good.

  3. ANALYSIS OF CORPORATE SOCIAL RESPONSIBILITY, DEFAULT RISK AND CONSERVATISM EFFECT TO EARNING MANAGEMENT WITH GOOD CORPORATE GOVERNANCE AS MODERATING VARIABLE IN MANUFACTURING COMPANY WHOSE SHARES INCORPORATED IN INDONESIA SHARIA STOCK INDEX

    Directory of Open Access Journals (Sweden)

    Budi Gautama Siregar

    2018-05-01

    Full Text Available The purpose of this research is to examine and analyze Good Corporate Governance in moderating the relationship between Corporate Social Responsibility (as measured by economic, environmental and social, Default Risk (as measured by debt to equity ratio and debt to assets ratio and Conservatism (as measured by earning / stock return relation, accruals and net assets Earnings Management. The sample used is a manufacturing company during the period 2011- 2015. The total sample used is 170 samples. Sampling technique used is saturated sample method. The analytical model used in this research with Structural Equation Modeling. The results showed that Corporate Social Responsibility, as measured by the economy and environment, has a positive and significant effect on earning management, while Corporate Social Responsibility measured by social have negative and significant effect to earning management. Default risk, as measured by debt to equity ratio and debt to asset ratio, has positive and significant effect on Earnings Management. Also, conservatism measured by earning / stock return relation and accrual has adverse and insignificant effect on earning management. Good Corporate Governance moderates weakening the effect of Corporate Social Responsibility as measured by economic, environmental to Earnings Management. Meanwhile, the interaction of Corporate Social Responsibility proxy by social with good corporate governance has a positive and significant effect. Good Corporate Governance moderates weakening the effect of default risk measured by debt to equity ratio on Earnings Management, while the interaction between default risk measured by debt to asset ratio with good corporate governance has positive and insignificant effect, so GCG does not moderate the effect of default risk as measured by debt to asset ratio to Earnings Management. Another result was that good Corporate governance does not moderate Conservatism effect measured by Earning

  4. T cell responsiveness correlates differentially with antibody isotype levels in clinical and asymptomatic filariasis

    NARCIS (Netherlands)

    Yazdanbakhsh, M.; Paxton, W. A.; Kruize, Y. C.; Sartono, E.; Kurniawan, A.; van het Wout, A.; Selkirk, M. E.; Partono, F.; Maizels, R. M.

    1993-01-01

    To establish the relationships among T and B cell responses, active infection, and clinical manifestations in lymphatic filariasis, filarial-specific lymphocyte proliferation, IgG antibody isotypes, and IgE levels were determined in an exposed population: 31 asymptomatic amicrofilaremics, 43

  5. Refining Video Game Use Questionnaires for Research and Clinical Application: Detection of Problematic Response Sets

    Science.gov (United States)

    Faust, Kyle A.; Faust, David; Baker, Aaron M.; Meyer, Joseph F.

    2012-01-01

    Even when relatively infrequent, deviant response sets, such as defensive and careless responding, can have remarkably robust effects on individual and group data and thereby distort clinical evaluations and research outcomes. Given such potential adverse impacts and the widespread use of self-report measures when appraising addictions and…

  6. 77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

    Science.gov (United States)

    2012-11-20

    ...) is needed in order to assure the protection of the rights and welfare of human subjects in clinical... responsibilities. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and FDA have been actively working to...

  7. Clinical responsibility, accountability, and risk aversion in mental health nursing: a descriptive, qualitative study.

    Science.gov (United States)

    Manuel, Jenni; Crowe, Marie

    2014-08-01

    A number of recent, highly-publicized, perceived health-care service failures have raised concerns about health professionals' accountabilities. Relevant to these concerns, the present study sought to examine how mental health nurses understood clinical responsibility and its impact on their practice. A descriptive, qualitative design was used, and a convenience sample of 10 mental health nurses was recruited from specialist inpatient and outpatient mental health settings in Canterbury, New Zealand. Data were collected using semistructured interviews, and the transcriptions were analysed using an inductive, descriptive approach. Three major themes were identified: being accountable, fostering patient responsibility, and shifting responsibility. Being accountable involved weighing up patients' therapeutic needs against the potential for blame in an organizational culture of risk management. Fostering patient responsibility described the process of deciding in what situations patients could take responsibility for their behaviour. Shifting responsibility described the culture of defensive practice fostered by the organizational culture of risk aversion. The present study highlighted the challenges mental health nurses experience in relation to clinical responsibility in practice, including the balancing required between the needs of patients, the needs of the organization, and the perceived need for self-protection. © 2014 Australian College of Mental Health Nurses Inc.

  8. Learning in clinical practice: Stimulating and discouraging response to social comparison.

    Science.gov (United States)

    Raat, Janet; Kuks, Jan; Cohen-Schotanus, Janke

    2010-01-01

    Social comparison theory is relevant for learning in general. In a clinical context, we examined four hypotheses concerning: preferred other to compare with, preferred direction of comparison, response to social comparison and influence of personal social comparison orientation (SCO). To investigate the relevance of social comparison for clinical workplace learning. Students (n = 437) from nine different hospitals completed two questionnaires measuring their SCO and the direction of and response to their comparisons. t-tests were used to analyse the data. Students substantially did compare. They preferred to compare with peer students more than with residents or staff, and with peers doing better more than with peers doing worse. Their response to social comparison was more often stimulating for learning than discouraging. Students high in SCO reported a stronger stimulating and discouraging response to their comparisons than students low in SCO. Social comparison does play a role in clinical workplace learning. The mainly stimulating response to social comparison indicates a positive learning influence. The preferred comparison with peers emphasizes the role of peers in the learning process. Further research should focus on student comparison behaviour and on situations that strengthen the positive effects of social comparison and reduce the negative or obstructing ones.

  9. Predictive Factors of Clinical Response of Infliximab Therapy in Active Nonradiographic Axial Spondyloarthritis Patients

    Directory of Open Access Journals (Sweden)

    Zhiming Lin

    2015-01-01

    Full Text Available Objectives. To evaluate the efficiency and the predictive factors of clinical response of infliximab in active nonradiographic axial spondyloarthritis patients. Methods. Active nonradiographic patients fulfilling ESSG criteria for SpA but not fulfilling modified New York criteria were included. All patients received infliximab treatment for 24 weeks. The primary endpoint was ASAS20 response at weeks 12 and 24. The abilities of baseline parameters and response at week 2 to predict ASAS20 response at weeks 12 and 24 were assessed using ROC curve and logistic regression analysis, respectively. Results. Of 70 axial SpA patients included, the proportions of patients achieving an ASAS20 response at weeks 2, 6, 12, and 24 were 85.7%, 88.6%, 87.1%, and 84.3%, respectively. Baseline MRI sacroiliitis score (AUC = 0.791; P=0.005, CRP (AUC = 0.75; P=0.017, and ASDAS (AUC = 0.778, P=0.007 significantly predicted ASAS20 response at week 12. However, only ASDAS (AUC = 0.696, P=0.040 significantly predicted ASAS20 response at week 24. Achievement of ASAS20 response after the first infliximab infusion was a significant predictor of subsequent ASAS20 response at weeks 12 and 24 (wald χ2=6.87, P=0.009, and wald χ2=5.171, P=0.023. Conclusions. Infliximab shows efficiency in active nonradiographic axial spondyloarthritis patients. ASDAS score and first-dose response could help predicting clinical efficacy of infliximab therapy in these patients.

  10. Responses to clinical uncertainty in Australian general practice trainees: a cross-sectional analysis.

    Science.gov (United States)

    Cooke, Georga; Tapley, Amanda; Holliday, Elizabeth; Morgan, Simon; Henderson, Kim; Ball, Jean; van Driel, Mieke; Spike, Neil; Kerr, Rohan; Magin, Parker

    2017-12-01

    Tolerance for ambiguity is essential for optimal learning and professional competence. General practice trainees must be, or must learn to be, adept at managing clinical uncertainty. However, few studies have examined associations of intolerance of uncertainty in this group. The aim of this study was to establish levels of tolerance of uncertainty in Australian general practice trainees and associations of uncertainty with demographic, educational and training practice factors. A cross-sectional analysis was performed on the Registrar Clinical Encounters in Training (ReCEnT) project, an ongoing multi-site cohort study. Scores on three of the four independent subscales of the Physicians' Reaction to Uncertainty (PRU) instrument were analysed as outcome variables in linear regression models with trainee and practice factors as independent variables. A total of 594 trainees contributed data on a total of 1209 occasions. Trainees in earlier training terms had higher scores for 'Anxiety due to uncertainty', 'Concern about bad outcomes' and 'Reluctance to disclose diagnosis/treatment uncertainty to patients'. Beyond this, findings suggest two distinct sets of associations regarding reaction to uncertainty. Firstly, affective aspects of uncertainty (the 'Anxiety' and 'Concern' subscales) were associated with female gender, less experience in hospital prior to commencing general practice training, and graduation overseas. Secondly, a maladaptive response to uncertainty (the 'Reluctance to disclose' subscale) was associated with urban practice, health qualifications prior to studying medicine, practice in an area of higher socio-economic status, and being Australian-trained. This study has established levels of three measures of trainees' responses to uncertainty and associations with these responses. The current findings suggest differing 'phenotypes' of trainees with high 'affective' responses to uncertainty and those reluctant to disclose uncertainty to patients. More

  11. The effectiveness of nurse education and training for clinical alarm response and management: a systematic review.

    Science.gov (United States)

    Yue, Liqing; Plummer, Virginia; Cross, Wendy

    2017-09-01

    To identify the effectiveness of education interventions provided for nurses for clinical alarm response and management. Some education has been undertaken to improve clinical alarm response, but the evidence for evaluating effectiveness for nurse education interventions is limited. Systematic review. A systematic review of experimental studies published in English from 2005-2015 was conducted in four computerised databases (MEDLINE, EMBASE, CINAHL and Scopus). After identification, screening and appraisal using Joanna Briggs Institute instruments, quality research papers were selected, data extraction and analysis followed. Five studies met the inclusion criteria for alarm response and no articles were concerned with clinical alarm education for management. All had different types and methods of interventions and statistical pooling was not possible. Response accuracy, response time and perceptions were consistent when different interventions were adopted. A positive effect was identified when learning about general alarms, single alarms, sequential alarms and medium-level alarms for learning as the primary task. Nurses who were musically trained had a faster and more accurate alarm response. Simulation interventions had a positive effect, but the effect of education provided in the care unit was greater. Overall, clinical alarm awareness was improved through education activities. Nurses are the main users of healthcare alarms and work in complex environments with high numbers of alarms, including nuisance alarms and other factors. Alarm-related adverse events are common. The findings of a small number of experimental studies with diverse evidence included consideration of various factors when formulating education strategies. The factors which influence effectiveness of nurse education are nurse demographics, nurse participants with musical training, workload and characteristics of alarms. Education interventions based in clinical practice settings increase

  12. Sunitinib in urothelial cancer: clinical, pharmacokinetic, and immunohistochemical study of predictors of response.

    LENUS (Irish Health Repository)

    Gallagher, David J

    2012-02-01

    BACKGROUND: Sunitinib has activity in patients with metastatic urothelial cancer (UC), but most patients do not respond. OBJECTIVE: To identify predictors of response to sunitinib. DESIGN, SETTING, AND PARTICIPANTS: Seventy-seven patients with advanced UC received sunitinib on one of two schedules at a single institution. Blood pressure (BP), immunohistochemistry (IHC), and pharmacokinetic (PK) results were correlated with response to sunitinib. MEASUREMENTS: BP was assessed on day 1 and 28 of each cycle and on day 14 of cycle 1. IHC was performed on 55 samples from 38 cases using mammalian target of rapamycin and hypoxia-inducible factor (HIF) pathway marker antibodies. Blood samples for PK analysis were collected from 15 patients at three time points. Response was assessed using Response Evaluation Criteria in Solid Tumors criteria. RESULTS AND LIMITATIONS: Sunitinib-induced hypertension predicted improved response when hypertension was categorized as a discrete (p = 0.02) or continuous variable (p = 0.005 [systolic BP] and p = 0.007 [diastolic BP]). The odds ratio of response was 12.5 (95% confidence interval, 1.95-246.8) for grade 3\\/4 hypertension compared with grade 0. Response was associated with low HIF-1alpha expression in primary (p = 0.07) tissue. A nonstatistically significant trend was seen for an association between greater drug concentration and best response. A correlation between expression markers within the same pathways was identified, phosphorylated-4EBP1 and phosphorylated-S6 (p = 6.5 x 10(-9)), and vascular endothelial growth factor receptor 2 and HIF-1alpha (p = 0.008). Results are limited by small numbers. CONCLUSIONS: Clinical and molecular biomarkers of response to sunitinib may have clinical relevance and require prospective validation. There is an urgent need for predictive biomarkers to guide the management of UC.

  13. Comparison of breast-conserving surgery with mastectomy in locally advanced breast cancer after good response to neoadjuvant chemotherapy: A PRISMA-compliant systematic review and meta-analysis.

    Science.gov (United States)

    Sun, Yixuan; Liao, Mingjuan; He, Liu; Zhu, Chenfang

    2017-10-01

    The application of breast-conserving surgery (BCS) on patients with locally advanced breast cancer (LABC) with good response to neoadjuvant chemotherapy (NACT) still remains controversial. The objective in this study is to analyze the safety of BCS in the management of LABC in patients with good response to NACT. We searched the electronic databases of Medline (Pubmed) and Cochrane Library for reports on local recurrence (LR), regional recurrence (RR), distant recurrence (DR), 5-year disease-free survival (DFS) or 5-year overall survival (OS) in patients with LABC receiving BCS or mastectomy (MT) and with good response to NACT. Based on the research results, we conducted a meta-analysis using Review Manager 5.3. Our study showed that 16 studies with a combined total of 3531 patients, of whom 1465 patients underwent BCS, whereas 2066 patients underwent MT. There was no significant heterogeneity among these studies (Q statistic: P = .88; I = 0%). Patients with good response to NACT showed no significant difference in LR and RR [odd ratio (OR) = 0.83; 95% confidence interval (CI): 0.60-1.15; P = .26; OR = 0.56; 95% CI: 0.33-0.93; P = .03], while we figured out a lower DR (OR = 0.51; 95% CI: 0.42-0.63; P < .01), a higher DFS (OR = 2.35; 95% CI: 1.84 to 3.01, P < .01) and a higher OS (OR = 2.12; 95% CI: 1.51 to 2.98, P < .01) in BCS compared with MT. This meta-analysis concluded that BCS was a safe surgery for patients with LABC and had good response to NACT.

  14. Cell-mediated immune response: a clinical review of the therapeutic potential of human papillomavirus vaccination.

    Science.gov (United States)

    Meyer, Sonja Izquierdo; Fuglsang, Katrine; Blaakaer, Jan

    2014-12-01

    This clinical review aims to assess the efficacy of human papillomavirus 16/18 (HPV16/18) vaccination on the cell-mediated immune response in women with existing cervical intraepithelial neoplasia or cervical cancer induced by HPV16 or HPV18. A focused and thorough literature search conducted in five different databases found 996 publications. Six relevant articles were chosen for further review. In total, 154 patients (>18 years of age) were enrolled in prospective study trials with 3-15 months of follow up. The vaccine applications were administered two to four times. The vaccines contained different combinations of HPV16 and HPV18 and early proteins, E6 and E7. The primary outcome was the cell-mediated immune response. Correlation to clinical outcome (histopathology) and human leukocyte antigen genes were secondary endpoints. All vaccines triggered a detectable cell-mediated immune response, some of which were statistically significant. Correlations between immunological response and clinical outcome (histopathology) were not significant, so neoplasms may not be susceptible to vaccine-generated cytotoxic T cells (CD8(+)). Prophylactic HPV vaccines have been introduced to reduce the incidence of cervical cancer in young women. Women already infected with HPV could benefit from a therapeutic HPV vaccination. Hence, it is important to continue the development of therapeutic HPV vaccines to lower the rate of HPV-associated malignancies and crucial to evaluate vaccine efficacy clinically. This clinical review represents an attempt to elucidate the theories supporting the development of an HPV vaccine with a therapeutic effect on human papillomavirus-induced malignancies of the cervix. © 2014 Nordic Federation of Societies of Obstetrics and Gynecology.

  15. A comparative study of therapeutic response of patients with clinical chancroid to ciprofloxacin, erythromycin, and cotrimoxazole.

    Science.gov (United States)

    D'Souza, P; Pandhi, R K; Khanna, N; Rattan, A; Misra, R S

    1998-07-01

    Cotrimoxazole has traditionally been used as first drug for treatment of chancroid in India. With reports of increasing resistance to the drug, this study was conducted to compare treatment response of clinical chancroid between ciprofloxacin, 500 mg twice daily for 3 days, erythromycin, 500 mg four times daily for 7 days, and double-strength cotrimoxazole (trimethoprim 160 mg + sulfamethoxazole 800 mg), twice daily for 7 days. Forty-six patients with a clinical diagnosis of chancroid were randomly divided into 3 groups. Sixteen patients received ciprofloxacin, whereas 15 each received erythromycin and cotrimoxazole. Patients were seen on day 7, 14, and if needed day 21. Clinical response was noted in terms of cure, improvement, or failure. Excellent response was observed to both ciprofloxacin and erythromycin therapy with cure rates of 93.7% and 93.3%, respectively. Improvement was observed in 6.7% cases in both groups. There were no failures with either ciprofloxacin or erythromycin. Poor response to cotrimoxazole therapy was observed with 53.3% cure rates and a high failure rate of 46.7%. Ciprofloxacin and erythromycin are equally effective in chancroid. Ciprofloxacin is better in terms of dosage schedule, duration of treatment, and low cost. Cotrimoxazole should be discontinued as drug of choice because of high failure rates.

  16. Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia.

    LENUS (Irish Health Repository)

    Niemeyer, Charlotte M

    2015-01-01

    Juvenile myelomonocytic leukemia is a rare myeloproliferative disease in young children. While hematopoietic stem cell transplantation remains the only curative therapeutic option for most patients, children with juvenile myelomonocytic leukemia increasingly receive novel agents in phase I-II clinical trials as pre-transplant therapy or therapy for relapse after transplantation. However, response criteria or definitions of outcome for standardized evaluation of treatment effect in patients with juvenile myelomonocytic leukemia are currently lacking. Here we propose criteria to evaluate the response to the non-transplant therapy and definitions of remission status after hematopoietic stem cell transplantation. For the evaluation of non-transplant therapy, we defined 6 clinical variables (white blood cell count, platelet count, hematopoietic precursors and blasts in peripheral blood, bone marrow blast percentage, spleen size and extramedullary disease) and 3 genetic variables (cytogenetic, molecular and chimerism response) which serve to describe the heterogeneous picture of response to therapy in each individual case. It is hoped that these criteria will facilitate the comparison of results between clinical trials in juvenile myelomonocytic leukemia.

  17. The influence of innate and adaptative immune responses on the differential clinical outcomes of leprosy.

    Science.gov (United States)

    Fonseca, Adriana Barbosa de Lima; Simon, Marise do Vale; Cazzaniga, Rodrigo Anselmo; de Moura, Tatiana Rodrigues; de Almeida, Roque Pacheco; Duthie, Malcolm S; Reed, Steven G; de Jesus, Amelia Ribeiro

    2017-02-06

    Leprosy is a chronic infectious disease caused by Mycobacterium leprae. According to official reports from 121 countries across five WHO regions, there were 213 899 newly diagnosed cases in 2014. Although leprosy affects the skin and peripheral nerves, it can present across a spectrum of clinical and histopathological forms that are strongly influenced by the immune response of the infected individuals. These forms comprise the extremes of tuberculoid leprosy (TT), with a M. leprae-specific Th1, but also a Th17, response that limits M. leprae multiplication, through to lepromatous leprosy (LL), with M. leprae-specific Th2 and T regulatory responses that do not control M. leprae replication but rather allow bacterial dissemination. The interpolar borderline clinical forms present with similar, but less extreme, immune biases. Acute inflammatory episodes, known as leprosy reactions, are complications that may occur before, during or after treatment, and cause further neurological damages that can cause irreversible chronic disabilities. This review discusses the innate and adaptive immune responses, and their interactions, that are known to affect pathogenesis and influence the clinical outcome of leprosy.

  18. Traumatic Reticuloperitonitis in Water Buffalo (Bubalus bubalis: Clinical Findings and the Associated Inflammatory Response

    Directory of Open Access Journals (Sweden)

    Maged El-Ashker

    2013-01-01

    Full Text Available The present study was carried out to describe the clinical picture of traumatic reticuloperitonitis (TRP in water buffalo (Bubalus bubalis and to evaluate the inflammatory and immunologic responses for this clinical condition. Twenty-two buffalo with acute local TRP were monitored in our study. Additionally, 10 clinically healthy buffalo were randomly selected and served as controls. Acute local TRP was initially diagnosed by clinical examination and confirmed by ultrasonographic (USG examination and/or necropsy findings. Blood samples were collected from all examined buffalo to measure the respective levels of tumor necrosis factor alpha (TNF-α, interleukin (IL-1β, IL-6, IL-10 and interferon gamma (INF-γ, serum amyloid A (SAA, C-reactive protein (CRP, haptoglobin (Hp, fibrinogen (Fb, and serum sialic acid (SSA. It was found that TNF-α, IL-1β, IL-6, IL-10, SAA, CRP, Hp, Fb, and SSA were significantly higher in buffalo with TRP than the controls. Our findings suggest that the examined immunologic variables were helpful in documenting the inflammatory response in buffalo with TRP. However, their diagnostic usefulness only becomes apparent when considered in tandem with the clinical findings for any given animal, its anamnesis, and a subsequent USG assessment. Due to the frequent complications of TRP, more accurate indicators of its occurrence and severity would be useful.

  19. Safety, Clinical Response, and Microbiome Findings Following Fecal Microbiota Transplant in Children With Inflammatory Bowel Disease.

    Science.gov (United States)

    Goyal, Alka; Yeh, Andrew; Bush, Brian R; Firek, Brian A; Siebold, Leah M; Rogers, Matthew Brian; Kufen, Adam D; Morowitz, Michael J

    2018-01-18

    The role of fecal microbiota transplant (FMT) in the treatment of pediatric inflammatory bowel disease (IBD) is unknown. The aims of this study were to assess safety, clinical response, and gut microbiome alterations in children with Crohn's disease (CD), ulcerative colitis (UC), or indeterminate colitis (IC). In this open-label, single-center prospective trial, patients with IBD refractory to medical therapy underwent a single FMT by upper and lower endoscopy. Adverse events, clinical response, gut microbiome, and biomarkers were assessed at baseline, 1 week, 1 month, and 6 months following FMT. Twenty-one subjects were analyzed, with a median age of 12 years, of whom 57% and 28% demonstrated clinical response at 1 and 6 months post-FMT, respectively. Two CD patients were in remission at 6 months. Adverse events attributable to FMT were mild to moderate and self-limited. Patients prior to FMT showed decreased species diversity and significant microbiome compositional differences characterized by increased Enterobacteriaceae, Enterococcus, Haemophilus, and Fusobacterium compared with donors and demonstrated increased species diversity at 30 days post-FMT. At 6 months, these changes shifted toward baseline. Clinical responders had a higher relative abundance of Fusobacterium and a lower diversity at baseline, as well as a greater shift toward donor-like microbiome after FMT compared with nonresponders. A single FMT is relatively safe and can result in a short-term response in young patients with active IBD. Responders possessed increased Fusobacterium prior to FMT and demonstrated more significant microbiome changes compared with nonresponders after FMT. Microbiome characteristics may help in predicting response. © 2018 Crohn’s & Colitis Foundation of America. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  20. The procedure of new drug application and the philosophy of critical rationalism or the limits of quality assurance with good clinical practice.

    Science.gov (United States)

    Högel, J; Gaus, W

    1999-12-01

    K.R. Popper's philosophy of critical rationalism is concerned with the detection and removal of error. Fundamental contradictions exist between Popper's theory of knowledge and the present-day practice of the clinical investigation of new drugs. Currently, the public authorities concerned with the licensing of drugs pass judgment on trials, which are closely linked by the one-sponsor problem: the assertions made by the sponsor are not independently confirmed. This lack leads to excessive documentation and to costly monitoring and auditing, which are intended to ensure the credibility of results. In Popper's view, confirmatory trials, independent of the sponsor and supervised by the regulatory bodies, would be a better way to achieve reliable knowledge. The consequence would, among other things, be a reorganization of phase III of the clinical investigation of new drugs by dividing it into independent parts, one under the control of the sponsor and one under the control of the public authority. The implementation of this suggestion would lead to a more scientific manner of dealing with new drugs and to savings in terms of unproductive measures during the application process.

  1. Natural history and clinical response: "it's the virus, stupid, or is it the host?".

    Science.gov (United States)

    Nucara, Stefania; Caroleo, Benedetto; Guadagnino, Vincenzo; Perrotti, Nicola; Trapasso, Francesco

    2012-01-01

    A major goal of modern medicine is the application of personalized therapies, consisting of decisions and practices tailored to the individual patient. Information about genetic variants, either mutant or polymorphic, represents the basis for the development of this clinical approach. Recently, several independent genome-wide association studies (GWAS) have identified two single nucleotide polymorphisms (SNPs) on the IL28B locus associated with HCV containment, spontaneous clearance, treatment response, and disease progression. In this minireview we will concisely discuss some critical genetic concepts that may have possible implications for clinical decisions in the treatment of HCV infection.

  2. Preoperative neutrophil response as a predictive marker of clinical outcome following open heart surgery and the impact of leukocyte filtration.

    LENUS (Irish Health Repository)

    Soo, Alan W

    2010-11-01

    Open heart surgery is associated with a massive systemic inflammatory response. Neutrophils, are the main mediator of this response. We hypothesised that the degree of neutrophil activation and inflammatory response to open heart surgery varies individually and correlates with clinical outcome. The aim of this study was to determine if individual clinical outcome can be predicted preoperatively through assessment of in-vitro stimulated neutrophil responses. Following that, the effects of neutrophil depletion through leukocyte filters are examined.

  3. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: Results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry

    DEFF Research Database (Denmark)

    Hetland, Merete Lund; Christensen, Ib Jarle; Tarp, Ulrik

    2010-01-01

    response were identified. The odds ratios (ORs) for clinical responses and remission and hazard ratios (HRs) for drug withdrawal were calculated, corrected for age, disease duration, the Disease Activity Score in 28 joints (DAS28), seropositivity, concomitant methotrexate and prednisolone, number...... versus etanercept. Similar predictors and ORs were observed for a good response according to the European League Against Rheumatism criteria, DAS28 remission, and Clinical Disease Activity Index remission. At 48 months, the HRs for drug withdrawal were 1.98 for infliximab versus etanercept (95% 1...

  4. How Do Psychiatrists Apply the Minimum Clinically Important Difference to Assess Patient Responses to Treatment?

    Directory of Open Access Journals (Sweden)

    Alan J. McMichael BSc

    2016-11-01

    Full Text Available Symptom report scales are used in clinical practice to monitor patient outcomes. Using them permits the definition of a minimum clinically important difference (MCID beyond which a patient may be judged as having responded to treatment. Despite recommendations that clinicians routinely use MCIDs in clinical practice, statisticians disagree about how MCIDs should be used to evaluate individual patient outcomes and responses to treatment. To address this issue, we asked how clinicians actually use MCIDs to evaluate patient outcomes in response to treatment. Sixty-eight psychiatrists made judgments about whether hypothetical patients had responded to treatment based on their pre- and posttreatment change scores on the widely used Positive and Negative Syndrome Scale. Psychiatrists were provided with the scale’s MCID on which to base their judgments. Our secondary objective was to assess whether knowledge of the patient’s genotype influenced psychiatrists’ responder judgments. Thus, psychiatrists were also informed of whether patients possessed a genotype indicating hyperresponsiveness to treatment. While many psychiatrists appropriately used the MCID, others accepted a far lower posttreatment change as indicative of a response to treatment. When psychiatrists accepted a lower posttreatment change than the MCID, they were less confident in such judgments compared to when a patient’s posttreatment change exceeded the scale’s MCID. Psychiatrists were also less likely to identify patients as responders to treatment if they possessed a hyperresponsiveness genotype. Clinicians should recognize that when judging patient responses to treatment, they often tolerate lower response thresholds than warranted. At least some conflate their judgments with information, such as the patient’s genotype, that is irrelevant to a post hoc response-to-treatment assessment. Consequently, clinicians may be at risk of persisting with treatments that have failed

  5. HOW GOOD IS GOODS AND SERVICES TAX

    OpenAIRE

    Dr. Sreemoyee Guha Roy

    2016-01-01

    Goods and Services Tax is a broad based and a single comprehensive tax levied on goods and services consumed in an economy. GST is levied at every stage of the production-distribution chain with applicable set offs in respect of the tax remitted at previous stages. It is basically a tax on final consumption. The Goods and Services Tax (GST) is a value added tax to be implemented in India, the decision on which is pending. GST is the only indirect tax that directly affects all sectors and sect...

  6. Immunohistochemical Expression of CD-10, BCL-6 and MUM-1 Antibodies and Immediate Clinical Response in Patients of Diffuse Large B-Cell Lymphomas after Six Cycles of Chemotherapy

    International Nuclear Information System (INIS)

    Hassan, U.; Ishtiaq, S.; Hussain, M.

    2014-01-01

    Objective: To determine the expression of CD-10, BCL-6 and MUM-1 in patients with diffuse large B-cell lymphoma (DLBCL) and its association with immediate clinical response after six cycles of CHOP chemotherapy. Study Design: Analytical study. Place and Duration of Study: Armed Forces Institute of Pathology (AFIP), Rawalpindi in collaboration with Nuclear medicine, Oncology and Radiotherapy Institute (NORI), Islamabad from September 2010 to September 2011. Methodology: CD-10, BCL-6 and MUM-1 antibodies were applied on cases diagnosed as DLBCL. Immediate clinical response was noted after 6 cycles of chemotherapy with the help of oncologist and divided into complete response, partial response, stable disease and relapse/ progression. Patient's age, results of expression of CD-10, BCL-6 and MUM-1 and results of immediate clinical response to chemotherapy were noted. Regarding analysis of prognostic markers (CD-10, BCL-6 and MUM-1), chi-square test was used for immediate clinical response to chemotherapy in DLBCL. Results: CD-10 was positive in 40% cases, BCL-6 in 58.7% cases and MUM-1 was positive in 46.7% cases. About 41.3% of patients showed complete response, 10.6% partial response, 17.3% stable disease and 30.8% showed relapse/progression. CD-10 expression in DLBCL was associated with better immediate clinical response (p = 0.011) whereas MUM-1 expression in DLBCL was associated with poor immediate clinical response (p < 0.0001). However, there was no statistically significant association of BCL-6 with immediate clinical response (p = 0.22). Conclusion: DLBCL shows expression of CD-10, BCL-6 and MUM-1 in nearly fifty percent of the cases. CD-10 is associated with good whereas MUM is associated with poor response. However, there was no association of BCL-6 with immediate clinical response. (author)

  7. Treatment of Spontaneous Subarachnoid Hemorrhage and Self-Reported Neuropsychological Performance at 6 Months - Results of a Prospective Clinical Pilot Study on Good-Grade Patients.

    Science.gov (United States)

    Bründl, Elisabeth; Schödel, Petra; Bele, Sylvia; Proescholdt, Martin; Scheitzach, Judith; Zeman, Florian; Brawanski, Alexander; Schebesch, Karl-Michael

    2018-01-01

    Limited focus has been placed on neuropsychological patient profiles after spontaneous subarachnoid hemorrhage (sSAH). We conducted a prospective controlled study in good-grade sSAH patients to evaluate the time course of treatment-specific differences in cognitive processing after sSAH. Twenty-six consecutive sSAH patients were enrolled (drop out n=5). Nine patients received endovascular aneurysm occlusion (EV), 6 patients were treated microsurgically (MS), and 6 patients with perimesencephalic SAH (pSAH) underwent standardized intensive medical care. No patient experienced serious vasospasm-related ischemic or hemorrhagic complications. All patients were subjected to neuropsychological self-report assessment (36-Item Short Form Health Survey and ICD-10-Symptom-Rating questionnaire) subacutely (day 11 - 35) after the onset of bleeding (t1) and at the 6-month follow-up (FU; t 2 ). From t1 to t 2 , MS and EV patients significantly improved in physical functioning (Pfi; p=.001 each) and the physical component summary (p=.010 vs. p=.015). Bodily pain (Pain; MS p=.034) and general health perceptions (EV p=.014) significantly improved, and nutrition disorder (EV p=.008) worsened. At FU, MS patients reported significantly better Pfi (vs. EV p=.046), less Pain (vs. EV p=.040), and more depression (vs. pSAH p=.035). Group-rate analyses of test differences showed a significant alleviation in nutrition disorder in MS (vs. EV p=.009). All sSAH groups reported a significant deterioration in health. Though both MS and EV patients, improved in several physical items over time, our data suggest a better short-term Pfi, less Pain and improved nutrition disorder in surgically treated patients. pSAH patients performed significantly better in various aspects of physical and psychological functioning than patients with aneurysmal SAH.

  8. High RAB25 expression is associated with good clinical outcome in patients with locally advanced head and neck squamous cell carcinoma

    International Nuclear Information System (INIS)

    Téllez-Gabriel, Marta; Arroyo-Solera, Irene; León, Xavier; Gallardo, Alberto; López, Montserrat; Céspedes, Maria V; Casanova, Isolda; López-Pousa, Antonio; Quer, Miquel; Mangues, Maria A; Barnadas, Agustí; Mangues, Ramón; Pavón, Miguel A

    2013-01-01

    Currently there are no molecular markers able to predict clinical outcome in locally advanced head and neck squamous cell carcinoma (HNSCC). In a previous microarray study, RAB25 was identified as a potential prognostic marker. The aim of this study was to analyze the association between RAB25 expression and clinical outcome in patients with locally advanced HNSCC treated with standard therapy. In a retrospective immunohistochemical study (n = 97), we observed that RAB25-negative tumors had lower survival (log-rank, P = 0.01) than patients bearing positive tumors. In an independent prospective mRNA study (n = 117), low RAB25 mRNA expression was associated with poor prognosis. Using classification and regression tree analysis (CART) we established two groups of patients according to their RAB25 mRNA level and their risk of death. Low mRNA level was associated with poor local recurrence-free (log-rank, P = 0.005), progression-free (log-rank, P = 0.002) and cancer-specific (log-rank, P < 0.001) survival. Multivariate Cox model analysis showed that low expression of RAB25 was an independent poor prognostic factor for survival (hazard ratio: 3.84, 95% confidence interval: 1.93–7.62, P < 0.001). Patients whose tumors showed high RAB25 expression had a low probability of death after treatment. We also found lower RAB25 expression in tumors than in normal tissue (Mann–Whitney U, P < 0.001). Moreover, overexpression of RAB25 in the UM-SCC-74B HNSCC cell line increased cisplatin sensitivity, and reduced cell migration and invasion. Our findings support a tumor suppressor role for RAB25 in HNSCC and its potential use to identify locally advanced patients with a high probability of survival after genotoxic treatment

  9. For the Good of All : Integrating corporate social responsibility into the business strategy of small and medium sized enterprises in Finland: CASE: Oy Vallila Interior Ab

    OpenAIRE

    Anttila, Hannele

    2010-01-01

    Corporate social responsibility (CSR) can be defined as a concept that includes simultaneous fulfilment of a company’s economic, legal, ethical and philanthropic responsibilities, as well as companies integrating social and environmental concerns in their business operations and in their interaction with their stakeholders on a voluntary basis. The purpose of this dissertation is to investigate CSR from the perspective of small and medium sized enterprises (SMEs), more specifically from t...

  10. Effect of response format for clinical vignettes on reporting quality of physician practice

    Directory of Open Access Journals (Sweden)

    Durieux Pierre

    2009-07-01

    Full Text Available Abstract Background Clinical vignettes have been used widely to compare quality of clinical care and to assess variation in practice, but the effect of different response formats has not been extensively evaluated. Our objective was to compare three clinical vignette-based survey response formats – open-ended questionnaire (A, closed-ended (multiple-choice questionnaire with deceptive response items mixed with correct items (B, and closed-ended questionnaire with only correct items (C – in rheumatologists' pre-treatment assessment for tumor-necrosis-factor (TNF blocker therapy. Methods Study design: Prospective randomized study. Setting: Rheumatologists attending the 2004 French Society of Rheumatology meeting. Physicians were given a vignette describing the history of a fictitious woman with active rheumatoid arthritis, who was a candidate for therapy with TNF blocking agents, and then were randomized to receive questionnaire A, B, or C, each containing the same four questions but with different response formats, that asked about their pretreatment assessment. Measurements: Long (recommended items and short (mandatory items checklists were developed for pretreatment assessment for TNF-blocker therapy, and scores were expressed on the basis of responses to questionnaires A, B, and C as the percentage of respondents correctly choosing explicit items on these checklists. Statistical analysis: Comparison of the selected items using pairwise Chi-square tests with Bonferonni correction for variables with statistically significant differences. Results Data for all surveys distributed (114 As, 118 Bs, and 118 Cs were complete and available for analysis. The percentage of questionnaire A, B, and C respondents for whom data was correctly complete for the short checklist was 50.4%, 84.0% and 95.0%, respectively, and was 0%, 5.0% and 5.9%, respectively, for the long version. As an example, 65.8%, 85.7% and 95.8% of the respondents of A, B, and C

  11. Clinical features and early treatment response of central nervous system involvement in childhood acute lymphoblastic leukemia

    DEFF Research Database (Denmark)

    Levinsen, Mette; Taskinen, Mervi; Abrahamsson, Jonas

    2014-01-01

    BACKGROUND: Central nervous system (CNS) involvement in childhood acute lymphoblastic leukemia (ALL) remains a therapeutic challenge. PROCEDURE: To explore leukemia characteristics of patients with CNS involvement at ALL diagnosis, we analyzed clinical features and early treatment response of 744...... leukemia and patients without such characteristics (0.50 vs. 0.61; P = 0.2). CONCLUSION: CNS involvement at diagnosis is associated with adverse prognostic features but does not indicate a less chemosensitive leukemia....

  12. Inspiring hope-A physician's responsibility, translating the science into clinical practice.

    Science.gov (United States)

    Temple, Walley J

    2018-03-01

    Giving hope to patients is our responsibility. It is the essence of a meaningful practice in medicine. Science now allows us to understand this complex and multidimensional human dynamic, and translate it into clinical practice. Quantitative research has shown hope is strong even in terminal illness. Through qualitative methodology hope fostering strategies and hope hindering behaviors have been identified. This exciting new knowledge facilitates the challenging task of disclosure of bad news while enabling hope. © 2017 Wiley Periodicals, Inc.

  13. The expanding spectrum of clinically-distinctive, immunotherapy-responsive autoimmune encephalopathies

    Directory of Open Access Journals (Sweden)

    Sarosh R Irani

    2012-04-01

    Full Text Available The autoimmune encephalopathies are a group of conditions that are associated with autoantibodies against surface neuronal proteins, which are likely to mediate the disease. They are established as a frequent cause of encephalitis. Characteristic clinical features in individual patients often allow the specificity of the underlying antibody to be confidently predicted. Antibodies against the VGKC-complex, mainly LGI1(leucine-rich glioma-inactivated 1, CASPR2 (contactin-associated protein 2, and contactin-2, and NMDA (N-methyl, D-aspartate -receptor are the most frequently established serological associations. In the minority of cases, an underlying tumour can be responsible. Early administration of immunotherapies, and tumour removal, where it is relevant, offer the greatest chance of improvement. Prolonged courses of immunotherapies may be required, and clinical improvements often correlate well with the antibody levels. In the present article, we have summarised recent developments in the clinical and laboratory findings within this rapidly expanding field.

  14. Catatonia: Etiopathological diagnoses and treatment response in a tertiary care setting: A clinical study

    Directory of Open Access Journals (Sweden)

    Santosh Ramdurg

    2013-01-01

    Full Text Available Aim: Catatonia is caused by a variety of psychiatric and organic conditions. The onset, clinical profile, and response to treatment may vary depending on the underlying cause. The study is an attempt to explore clinical profile, possible etiological correlates with neurotic/psychotic spectrum illnesses, and response to treatment and outcome in patients of catatonia. Materials and Methods: Retrospective chart analysis by using semistructured data sheet for the analysis of sociodemographic data, clinical profile, precipitating event, and response to treatment in patients with catatonic symptoms admitted to IHBAS (Institute of Human Behaviour and Allied Sciences, New Delhi, India from January 2009 to December 2010 was undertaken. Results: Catatonia was commonly observed in patients with the following profile - late twenties, female, Hindu religion, urban background, and housewives. Psychotic spectrum disorder (57%, N=35 was the most commonly entertained diagnosis and affective disorder (18%, N=11 being the second common. Thirty four percent of the subjects responded to lorazepam treatment and rest required modified electroconvulsive therapy (MECT. Conclusion: Catatonia is more likely to be associated with Schizophrenia and Other Psychotic Disorders in Indian settings. Majority of patients responded to therapy either by lorazepam alone or to its augmentation with modified ECT. The study being a retrospective one, the sample being representative of the treatment seeking group only, and unavailability of the follow up data were the limitations of the study

  15. Immunological, clinical, haematological and oxidative responses to long distance transportation in horses.

    Science.gov (United States)

    Padalino, Barbara; Raidal, Sharanne Lee; Carter, Nicole; Celi, Pietro; Muscatello, Gary; Jeffcott, Leo; de Silva, Kumudika

    2017-12-01

    Horses are transported frequently and often over long distances. Transportation may represent a physiological stressor with consequential health and welfare implications. This study reports the effects of a long distance journey on immunological, clinical, haematological, inflammatory and oxidative parameters in an Experimental Group (EG) of ten horses, comparing them with six horses of similar age and breed used as a non-transported Control Group (CG). Clinical examination and blood sampling were performed twice on all horses: immediately after unloading for the EG, and at rest on the same day for the CG (day 1); at rest on the same day one week later for both groups (day 7). On day 1 EG horses showed increased heart and respiratory rates (Ptransportation induced an acute phase response impairing the cell-mediated immune response. Clinical examinations, including assessing CRT and body weight loss, and the monitoring of redox balance may be useful in evaluating the impact of extensive transport events on horses. A better understanding of the link between transportation stress, the immune system and the acute phase response is likely to inform strategies for enhancing the welfare of transported horses. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Alexithymia is associated with attenuated automatic brain response to facial emotion in clinical depression.

    Science.gov (United States)

    Suslow, Thomas; Kugel, Harald; Rufer, Michael; Redlich, Ronny; Dohm, Katharina; Grotegerd, Dominik; Zaremba, Dario; Dannlowski, Udo

    2016-02-04

    Alexithymia is a clinically relevant personality trait related to difficulties in recognizing and describing emotions. Previous studies examining the neural correlates of alexithymia have shown mainly decreased response of several brain areas during emotion processing in healthy samples and patients suffering from autism or post-traumatic stress disorder. In the present study, we examined the effect of alexithymia on automatic brain reactivity to negative and positive facial expressions in clinical depression. Brain activation in response to sad, happy, neutral, and no facial expression (presented for 33 ms and masked by neutral faces) was measured by functional magnetic resonance imaging at 3 T in 26 alexithymic and 26 non-alexithymic patients with major depression. Alexithymic patients manifested less activation in response to masked sad and happy (compared to neutral) faces in right frontal regions and right caudate nuclei than non-alexithymic patients. Our neuroimaging study provides evidence that the personality trait alexithymia has a modulating effect on automatic emotion processing in clinical depression. Our findings support the idea that alexithymia could be associated with functional deficits of the right hemisphere. Future research on the neural substrates of emotion processing in depression should assess and control alexithymia in their analyses.

  17. Clinical, haematological and biochemical responses of sheep undergoing autologous blood transfusion

    Directory of Open Access Journals (Sweden)

    Sousa Rejane

    2012-05-01

    Full Text Available Abstract Background This study aimed to evaluate the clinical, haematological and biochemical responses to autologous blood transfusion and the feasibility of this practice in sheep. Thus, we used eight male, 8 months old sheep, weighing on average 30 kg, from which 15 mL/kg of whole blood was collected and stored in CPDA-1 bags. Blood samples were refrigerated for 8 days and subsequently re-infused. The clinical, haematological and biochemical parameters were evaluated before blood collection and reinfusion, after 10 minutes of collection and reinfusion, after 3, 6, 12, 24, 48, 96 and 192 hours after collection and reinfusion. Results With respect to clinical parameters, we observed a decrease in heart rate after 24, 48 and 196 hours from reinfusion compared to basal values (p p p p  Conclusion Autologous transfusion in sheep slightly altered the physiological, biochemical and haematological responses of sheep, indicating that the technique proposed is safe and can be applied in the clinical practice of this species. The 8 d period was not sufficient for complete recovery of the haematological parameters after blood collection.

  18. Bioenergy good practice

    Energy Technology Data Exchange (ETDEWEB)

    Birse, J.; Chambers, K.

    2000-07-01

    This report gives details of a project to make the Good Practice Guidelines, which were developed to help the UK Bioenergy industry, the national and local governments, and the public, more widely available. Details concerning the designing of a Good Practice Programme, and the proposed codes of Good Practice programme are given, and general relevant good practice guidance documents are discussed. The stakeholder survey and workshop, and the proposed codes of a Good Practice Programme are presented in Annexes. (UK)

  19. Analysis of immunological profile, clinical features and response to treatment in pemphigus.

    Science.gov (United States)

    Bardazzi, Federico; Balestri, Riccardo; Ismaili, Alma; LA Placa, Michelangelo; Barisani, Alessia; Patrizi, Annalisa

    2017-12-01

    Pemphigus is an autoimmune disease, characterized by the presence of serum autoantibodies against Desmoglein (Dsg) 1 and 3. It can affect the skin and/or the mucous membranes. Some authors found a correlation between the serum levels of autoantibodies, disease activity and clinical phenotype of pemphigus. Anti Dsg1 autoantibodies appear related to cutaneous phenotype, anti Dsg3 autoantibodies to mucosal involvement. From 2011 to 2014, in patients with pemphigus, the serum levels of anti-Dsg1 and 3 antibodies were determined with enzyme-linked immuno-sorbent assay at diagnosis and after 6 months of different therapies. The correlations between levels of autoantibodies, clinical phenotype, clinical activity and response to therapy, were investigated. Thirty-five patients were included. Clinical phenotypes were: mucosal in 17 patients; mucous-cutaneous in 11; and cutaneous in 7. The status of anti-Dsg1 autoantibodies was significantly related to the cutaneous and mucous-cutaneous phenotypes both at diagnosis and after 6 months. The status of anti-Dsg3 autoantibodies was significantly related to the mucosal and mucous-cutaneous phenotypes only at first evaluation. No significant correlations were found between disease activity and the status of autoantibodies. No significant variations of autoantibody levels (between first and second sample) were found with regard to different therapies, except for the variation of anti-Dsg1 autoantibodies in one patient treated with systemic steroids and methotrexate. A correlation between serum levels of autoantibodies and clinical phenotype was found. Further studies over a longer follow-up period may better characterize the correlation between autoantibody levels, clinical activity and response to different therapies of pemphigus.

  20. Thalidomide in induction treatment increases the very good partial response rate before and after high-dose therapy in previously untreated multiple myeloma.

    NARCIS (Netherlands)

    Lokhorst, H.M.; Schmidt-Wolf, I.; Sonneveld, P.; Holt, B. van der; Martin, H.; Barge, R.; Bertsch, U.; Schlenzka, J.; Bos, G.M.; Croockewit, S.; Zweegman, S.; Breitkreutz, I.; Joosten, P.; Scheid, C.; Marwijk-Kooy, M. van; Salwender, H.J.; Oers, M.H. van; Schaafsma, R.; Naumann, R.; Sinnige, H.A.M.; Blau, I.; Delforge, M.; Weerdt, O. de; Wijermans, P.W.; Wittebol, S.; Duersen, U.; Vellenga, E.; Goldschmidt, H.

    2008-01-01

    In the prospective phase 3 HOVON-50/GMMG-HD3 trial, patients randomized to TAD (thalidomide, doxorubicin, dexamethasone) had a significantly higher response rate (at least PR) after induction compared with patients randomized to VAD (vincristine, adriamycin, dexamethasone, 72% vs. 54%, p<0.001).

  1. Proteomics of inflammatory and oxidative stress response in cows with subclinical and clinical mastitis.

    Science.gov (United States)

    Turk, Romana; Piras, Cristian; Kovačić, Mislav; Samardžija, Marko; Ahmed, Hany; De Canio, Michele; Urbani, Andrea; Meštrić, Zlata Flegar; Soggiu, Alessio; Bonizzi, Luigi; Roncada, Paola

    2012-07-19

    Cow serum proteome was evaluated by three different complementary approaches in the control group, subclinical and clinical mastitis in order to possibly find differential protein expression useful for a better understanding of the pathophysiology of mastitis as well as for an early diagnosis of the disease. The systemic inflammatory and oxidative stress response in cows with subclinical and clinical mastitis were observed. The collected evidence shows a differential protein expression of serpin A3-1, vitronectin-like protein and complement factor H in subclinical mastitis in comparison with the control. It was also found a differential protein expression of inter-alpha-trypsin inhibitor heavy chain H4, serpin A3-1, C4b-binding protein alpha chain, haptoglobin and apolipoprotein A-I in clinical mastitis compared to the control. Among the inflammatory proteins up-regulated in clinical mastitis, vitronectin is over-expressed in both subclinical and clinical mastitis indicating a strong bacterial infection. This suggests vitronectin as an important mediator in the pathogenesis of the onset of mastitis as well as a valuable marker for diagnosis of the subclinical form of the disease. Obtained data could be useful for the detection of mastitis during the subclinical phase and for a better comprehension of the pathophysiological mechanisms involved in the onset of the disease. Copyright © 2012 Elsevier B.V. All rights reserved.

  2. The Localized Scleroderma Cutaneous Assessment Tool: responsiveness to change in a pediatric clinical population.

    Science.gov (United States)

    Kelsey, Christina E; Torok, Kathryn S

    2013-08-01

    Lack of agreement on how to accurately capture disease outcomes in localized scleroderma (LS) has hindered the development of efficacious treatment protocols. The LS Cutaneous Assessment Tool (LoSCAT), consisting of the modified LS Skin Severity Index (mLoSSI) and the LS Damage Index, has potential for use in clinical trials. The goal of this article is to further evaluate the clinical responsiveness of the LoSCAT. Based on the modifiable nature of disease activity versus damage, we expected the mLoSSI to be responsive to change. At 2 study visits, a physician completed the LoSCAT and Physician Global Assessment (PGA) of Disease Activity and of Disease Damage for 29 patients with LS. Spearman correlations were used to examine the relationships between the change in the LoSCAT and the PGA scores. To evaluate contrasted group validity, patients were grouped according to disease activity classification and change scores of groups were compared. Minimal clinically important differences were calculated and compared with the standard error of measurement. Change in the mLoSSI score correlated strongly with change in the PGA of Disease Activity score, whereas change in the LS Damage Index score correlated weakly with change in the PGA of Disease Damage score. The mLoSSI and PGA of Disease Activity exhibited contrasted group validity. Minimal clinically important differences for the activity measures were greater than the respective standard errors of measurement. Only 2 study visits were included in analysis. This study gives further evidence that the LoSCAT, specifically the mLoSSI, is a responsive, valid measure of activity in LS and should be used in future treatment studies. Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  3. Clinical, Radiologic, and Legal Significance of "Extensor Response" in Posttraumatic Coma.

    Science.gov (United States)

    Firsching, Raimund; Woischneck, Dieter; Langejürgen, Alexander; Parreidt, Andreas; Bondar, Imre; Skalej, Martin; Röhl, Friedrich; Voellger, Benjamin

    2015-11-01

    The timely detection of neurologic deterioration can be critical for the survival of a neurosurgical patient following head injury. Because little reliable evidence is available on the prognostic value of the clinical sign "extensor response" in comatose posttraumatic patients, we investigated the correlation of this clinical sign with outcome and with early radiologic findings from magnetic resonance imaging (MRI). This retrospective analysis of prospectively obtained data included 157 patients who had remained in a coma for a minimum of 24 hours after traumatic brain injury. All patients received a 1.5-T MRI within 10 days (median: 2 days) of the injury. The correlations between clinical findings 12 and 24 hours after the injury-in particular, extensor response and pupillary function, MRI findings, and outcome after 1 year-were investigated. Statistical analysis included contingency tables, Fisher exact test, odds ratios (ORs) with confidence intervals (CIs), and weighted κ values. There were 48 patients with extensor response within the first 24 hours after the injury. Patients with extensor response (World Federation of Neurosurgical Societies coma grade III) statistically were significantly more likely to harbor MRI lesions in the brainstem when compared with patients in a coma who had no further deficiencies (coma grade I; p = 0.0004 by Fisher exact test, OR 10.8 with 95% CI, 2.7-42.5) and patients with unilateral loss of pupil function (coma grade II; p = 0.0187, OR 2.8 with 95% CI, 1.2-6.5). The correlation of brainstem lesions as found by MRI and outcome according to the Glasgow Outcome Scale after 1 year was also highly significant (p ≤ 0.016). The correlation of extensor response and loss of pupil function with an unfavorable outcome and with brainstem lesions revealed by MRI is highly significant. Their sudden onset may be associated with the sudden onset of brainstem dysfunction and should therefore be regarded as one of the most

  4. Childhood optic chiasm gliomas: radiographic response following radiotherapy and long-term clinical outcome

    International Nuclear Information System (INIS)

    Tao, May L.; Barnes, Patrick D.; Billett, Amy L.; Leong, Traci; Shrieve, Dennis C.; Scott, R. Michael; Tarbell, Nancy J.

    1997-01-01

    Purpose: In children with chiasmal gliomas, radiation therapy can arrest progressive visual and neurologic impairment. We examined the radiographic response and clinical outcomes after irradiation. Methods and Materials: Forty-two children (median age at diagnosis, 6.6 years) with chiasmal gliomas were managed as follows: 11 asymptomatic patients with neurofibromatosis-1 (NF-1) were observed only; 2 patients, less than 3 years old, underwent surgery and chemotherapy to delay irradiation; and 29 patients with progressive disease received radiation with or without prior surgery or chemotherapy. Time to radiographic response, long-term tumor control and late sequelae were reviewed for the 29 irradiated patients. Results: The probability of at least 50% radiographic response at 24 months after irradiation was 18.1% and increased to 38.2% by 48 months and 45.9% by 60 months. By actuarial analysis, the median time for such radiographic response was 62 months. For the 29 irradiated patients, the 10-year freedom from progression and overall survival rates were 100% and 89%, respectively (median follow-up for surviving patients, 108 months). Stabilization or improvement in vision occurred in 81% of 26 evaluable irradiated patients. Conclusions: Notable radiographic response may be observed years after irradiation. Radiation therapy provides excellent long-term tumor control and vision preservation or improvement in the majority of patients with progressive chiasmal gliomas

  5. Evaluation of the response to treatment and clinical evolution in patients with burning mouth syndrome

    Science.gov (United States)

    Rodríguez-de Rivera-Campillo, Eugenia

    2013-01-01

    Objective: the aim of this study is to investigate the clinical evolution, the spontaneous remission of the symptomatology and the response to different treatments in a group of burning mouth syndrome patients. Study Design: the sample was formed by a group of patients that were visited in the Unit of Oral Medicine of the Dentistry Clinic of the University of Barcelona, from the year 2000 to 2011. After revising the clinical records of all the patients that had been under control for a period of time of 18 months or longer, they were contacted by telephone. In the telephone interview, they were questioned about the symptomatology evolution and the response to the treatments received, noting down the data in a questionnaire previously performed. Results: the average duration of the symptoms was 6.5 years (+/-2.5 years). The most frequent treatments were: chlorhexidine mouthrinses, oral benzodiazepines, topical clonazepam, antiinflamatory drugs, antidepressants, antifungicals, vitamins, psycotherapy, salivary substitutes and topical corticoids. The specialists that were consulted with a higher frequency were: dermatologists (30%), othorrynolaringologists (10%) and psychiatrists (3%). In 41 patients the oral symptoms did not improve, 35 reported partial improvements, 12 patients worsened, and only in 3 patients the symptoms remitted. Conclusions: In three of the 91 patients studied the symptoms remitted spontaneously within the five years of treatment. Only 42% of the study population had improved the symptomatology significantly, and this improvement would reach 60% if clonazepam were associated to psychotherapy. Key words:Burning mouth syndrome, stomatodynia, oral pain, clonazepam. PMID:23229252

  6. Study on the Mg-Li-Zn ternary alloy system with improved mechanical properties, good degradation performance and different responses to cells.

    Science.gov (United States)

    Liu, Yang; Wu, Yuanhao; Bian, Dong; Gao, Shuang; Leeflang, Sander; Guo, Hui; Zheng, Yufeng; Zhou, Jie

    2017-10-15

    Novel Mg-(3.5, 6.5wt%)Li-(0.5, 2, 4wt%)Zn ternary alloys were developed as new kinds of biodegradable metallic materials with potential for stent application. Their mechanical properties, degradation behavior, cytocompatibility and hemocompatibility were studied. These potential biomaterials showed higher ultimate tensile strength than previously reported binary Mg-Li alloys and ternary Mg-Li-X (X=Al, Y, Ce, Sc, Mn and Ag) alloys. Among the alloys studied, the Mg-3.5Li-2Zn and Mg-6.5Li-2Zn alloys exhibited comparable corrosion resistance in Hank's solution to pure magnesium and better corrosion resistance in a cell culture medium than pure magnesium. Corrosion products observed on the corroded surface were composed of Mg(OH) 2 , MgCO 3 and Ca-free Mg/P inorganics and Ca/P inorganics. In vitro cytotoxicity assay revealed different behaviors of Human Umbilical Vein Endothelial Cells (HUVECs) and Human Aorta Vascular Smooth Muscle Cells (VSMCs) to material extracts. HUVECs showed increasing nitric oxide (NO) release and tolerable toxicity, whereas VSMCs exhibited limited decreasing viability with time. Platelet adhesion, hemolysis and coagulation tests of these Mg-Li-Zn alloys showed different degrees of activation behavior, in which the hemolysis of the Mg-3.5Li-2Zn alloy was lower than 5%. These results indicated the potential of the Mg-Li-Zn alloys as good candidate materials for cardiovascular stent applications. Mg-Li alloys are promising as absorbable metallic biomaterials, which however have not received significant attention since the low strength, controversial corrosion performance and the doubts in Li toxicity. The Mg-Li-Zn alloy in the present study revealed much improved mechanical properties higher than most reported binary Mg-Li and ternary Mg-Li-X alloys, with superior corrosion resistance in cell culture media. Surprisingly, the addition of Li and Zn showed increased nitric oxide release. The present study indicates good potential of Mg-Li-Zn alloy as

  7. Trade in goods

    DEFF Research Database (Denmark)

    Sørensen, Karsten Engsig

    2006-01-01

    An analysis of the rules governing trade in goods under the GATT agreement and the Agreement on Safeguards......An analysis of the rules governing trade in goods under the GATT agreement and the Agreement on Safeguards...

  8. The human immune response to streptococcal extracellular antigens: clinical, diagnostic, and potential pathogenetic implications.

    Science.gov (United States)

    Johnson, Dwight R; Kurlan, Roger; Leckman, James; Kaplan, Edward L

    2010-02-15

    Determination of an immune response to group A Streptococcus (GAS) antigens, frequently anti-streptolysin O and anti-DNase B, is crucial for documentation of bona fide GAS infection. Although the importance of immunologic confirmation of infection is widely accepted, the immediate and long-term immunokinetics of the human antibody response are incompletely documented and poorly understood. Pediatric study participants (n = 160) were followed during a 2-year study with monthly throat cultures (n = 3491) and blood samples (n = 1679) obtained every 13 weeks. Recovered GAS were characterized; serum anti-streptolysin O and anti-DNase B antibody titers were determined. Antibody titers and GAS culture results were temporally correlated and analyzed. The analyses clearly document, in some instances for the first time, that an increase in antibody titer more accurately defines infection than does an absolute titer (eg, "upper limit of normal"), that antibody titers can remain elevated for many months even without GAS, and that some individuals may harbor GAS continuously for months or years without symptoms of infection and without an associated immune response. Measuring 2 different antibodies is more accurate in defining infection. Single time-point cultures and single antibody titers are often misleading. Sequential samples more accurately define infection, allowing correlation of titer increases with temporal confirmation of GAS acquisition. Understanding kinetics of the immune response(s) to GAS infection is necessary in formulating accurate clinical diagnostic conclusions, to appropriate design of clinical and epidemiological studies examining the association of GAS with subsequent sequelae, and to providing insight into pathogenetic mechanisms associated with this important human pathogen.

  9. Long lasting clinical response to chemotherapy for advanced uterine leiomyosarcoma: a case report.

    Science.gov (United States)

    Ridolfi, Claudio; Pasini, Giuseppe; Drudi, Fabrizio; Barzotti, Eleonora; Santelmo, Carlotta; Polselli, Antonio; Ravaioli, Alberto

    2013-01-24

    Uterine leiomyosarcoma is one of the most frequent uterine sarcomas. In the metastatic setting it is sensitive to doxorubicin, ifosfamide, gemcitabine, docetaxel and a few other drugs, but time to progression is generally short. For this reason prognosis is often poor and there are few reports in the literature of long responders. We report a case of a 40-year-old Caucasian woman with metastatic uterine leiomyosarcoma who began treatment six years before the presentation of this case report and for the following six years underwent ten lines of chemotherapy, achieving excellent results and a good quality of life. Among the treatments administered we observed a long response to temolozomide, an unconventional drug for this kind of disease. Although there are few chemotherapeutic options for the management of metastatic uterine leiomyosarcoma, a small number of patients have an unexpected long lasting response to treatment. For this reason further research is needed to identify new therapeutic agents and the predictive factors for the achievement of response.

  10. Long lasting clinical response to chemotherapy for advanced uterine leiomyosarcoma: a case report

    Directory of Open Access Journals (Sweden)

    Ridolfi Claudio

    2013-01-01

    Full Text Available Abstract Introduction Uterine leiomyosarcoma is one of the most frequent uterine sarcomas. In the metastatic setting it is sensitive to doxorubicin, ifosfamide, gemcitabine, docetaxel and a few other drugs, but time to progression is generally short. For this reason prognosis is often poor and there are few reports in the literature of long responders. Case presentation We report a case of a 40-year-old Caucasian woman with metastatic uterine leiomyosarcoma who began treatment six years before the presentation of this case report and for the following six years underwent ten lines of chemotherapy, achieving excellent results and a good quality of life. Among the treatments administered we observed a long response to temolozomide, an unconventional drug for this kind of disease. Conclusion Although there are few chemotherapeutic options for the management of metastatic uterine leiomyosarcoma, a small number of patients have an unexpected long lasting response to treatment. For this reason further research is needed to identify new therapeutic agents and the predictive factors for the achievement of response.

  11. Good Concrete Activity Is Good Mental Activity

    Science.gov (United States)

    McDonough, Andrea

    2016-01-01

    Early years mathematics classrooms can be colourful, exciting, and challenging places of learning. Andrea McDonough and fellow teachers have noticed that some students make good decisions about using materials to assist their problem solving, but this is not always the case. These experiences lead her to ask the following questions: (1) Are…

  12. A Good Suit Beats a Good Idea.

    Science.gov (United States)

    Machiavelli, Nick

    1992-01-01

    Inspired by Niccolo Machiavelli, this column offers beleaguered school executives advice on looking good, dressing well, losing weight, beating the proper enemy, and saying nothing. Administrators who follow these simple rules should have an easier life, jealous colleagues, well-tended gardens, and respectful board members. (MLH)

  13. Veracity in big data: How good is good enough.

    Science.gov (United States)

    Reimer, Andrew P; Madigan, Elizabeth A

    2018-01-01

    Veracity, one of the five V's used to describe big data, has received attention when it comes to using electronic medical record data for research purposes. In this perspective article, we discuss the idea of data veracity and associated concepts as it relates to the use of electronic medical record data and administrative data in research. We discuss the idea that electronic medical record data are "good enough" for clinical practice and, as such, are "good enough" for certain applications. We then propose three primary issues to attend to when establishing data veracity: data provenance, cross validation, and context.

  14. Indication of attenuated DHEA-s response during acute psychosocial stress in patients with clinical burnout.

    Science.gov (United States)

    Lennartsson, Anna-Karin; Sjörs, Anna; Jonsdottir, Ingibjörg H

    2015-08-01

    Dehydroepiandrosterone sulphate (DHEA-s) is an anabolic protective hormone. We have previously reported that DHEA-s production capacity is attenuated in stressed individuals. The aim of the present study was to investigate the DHEA-s response during acute psychosocial stress in patients with clinical burnout. Seventeen patients with clinical burnout were compared to 13 non-chronically stressed healthy controls, aged 31-50 years (mean age 41 years, SD 6 years), as they underwent the Trier Social Stress Test (TSST). All patients fulfilled diagnostic criteria for stress-related exhaustion disorder, which is a criteria-based diagnosis that has been used in Sweden since 2005 to define patients seeking health-care for clinical burnout. Blood samples were collected before, directly after the stress test, and after 30 min of recovery. DHEA-s levels were measured and delta values (peak levels minus baseline levels) plus area under the curve with respect to increase (AUCI) were calculated. The patients had 43% smaller AUCI DHEA-s (p=0.041) during the stress test. The delta DHEA-s was 34% lower in the patients, however, this difference was not statistically significant (p=0.054). The study indicates that DHEA-s production capacity during acute stress may be attenuated in patients with clinical burnout. Reduced DHEA-s production may constitute one of the links between stress, burnout and the associated adverse health. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Clinical application of Chamomilla recutita in phlebitis: dose response curve study.

    Science.gov (United States)

    Reis, Paula Elaine Diniz Dos; Carvalho, Emilia Campos de; Bueno, Paula Carolina Pires; Bastos, Jairo Kenupp

    2011-01-01

    This experimental and dose-response curve study aimed to carry out the quality control of the Chamomilla recutita sample, as well as to estimate the ideal dose, for anti-inflammatory effect, of the extract of its capitula, in patients with phlebitis due to peripheral intravenous infusion of antineoplastic chemotherapy and to evaluate the toxicity of this extract in human beings. The therapeutic efficacy, concerning the anti-inflammatory potential, of different doses of Chamomilla recutita extract were analyzed and compared in 25 patients. The time of regression of phlebitis was shorter for groups with 2.5% concentration (mean=29.2h, standard deviation = 8.98) and 5% concentration (mean = 38.8h, standard deviation = 17.47). Local toxicity was almost not observed. This research contributes to the innovation of the nursing clinical practice, since it suggests an alternative for the treatment of phlebitis through the clinical use of phytotherapeutic drugs.

  16. Inflammatory mammary carcinoma in 12 dogs: Clinical features, cyclooxygenase-2 expression, and response to piroxicam treatment

    Science.gov (United States)

    de M. Souza, Carlos H.; Toledo-Piza, Evandro; Amorin, Renee; Barboza, Andrigo; Tobias, Karen M.

    2009-01-01

    Canine inflammatory mammary carcinoma (IMC) is a rare, locally aggressive, highly metastatic tumor that is poorly responsive to treatment. The purposes of this study were to retrospectively evaluate the history, signalment, and clinical signs of dogs with IMC; compare the outcome of affected dogs treated with traditional chemotherapy with those treated with piroxicam; evaluate Cox-2 expression of IMC cells; and correlate Cox-2 expression with outcome based on treatment. Strong cyclooxygenase-2 expression was present in all tumors. Improvement in clinical condition and disease stability was achieved in all dogs treated with piroxicam, with mean and median progression-free survival of 171 and 183 days, respectively. Median survival time of 3 dogs treated with doxorubicin-based protocols was 7 days, which was significantly less than that of dogs treated with piroxicam (median, 185 days). In conclusion, piroxicam should be considered as a single agent for the treatment of dogs with inflammatory mammary carcinoma. PMID:19436636

  17. Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria

    DEFF Research Database (Denmark)

    Abdulla, S.; Adam, I.; Adjei, G. O.

    2015-01-01

    values for clearance in patients from Sub-Saharan African countries with uncomplicated malaria treated with artemisinin-based combination therapies (ACTs). Methods: A literature review in PubMed was conducted in March 2013 to identify all prospective clinical trials (uncontrolled trials, controlled...... trials and randomized controlled trials), including ACTs conducted in Sub-Saharan Africa, between 1960 and 2012. Individual patient data from these studies were shared with the WorldWide Antimalarial Resistance Network (WWARN) and pooled using an a priori statistical analytical plan. Factors affecting...... early parasitological response were investigated using logistic regression with study sites fitted as a random effect. The risk of bias in included studies was evaluated based on study design, methodology and missing data. Results: In total, 29,493 patients from 84 clinical trials were included...

  18. Development of criteria for evaluating clinical response in thyroid eye disease using a modified Delphi technique

    DEFF Research Database (Denmark)

    Douglas, Raymond S; Tsirbas, Angelo; Gordon, Mark

    2009-01-01

    OBJECTIVE: To identify components of a provisional clinical response index for thyroid eye disease using a modified Delphi technique. METHODS: The International Thyroid Eye Disease Society conducted a structured, 3-round Delphi exercise establishing consensus for a core set of measures for clinical...... parsed into 11 domains for the Delphi surveys. Eighty-four respondents participated in the Delphi 1 survey, providing 220 unique items. Ninety-two members (100% of the respondents from Delphi 1 plus 8 new participants) responded in Delphi 2 and rated the same 220 items. Sixty-four members (76......% of participants) rated 153 criteria in Delphi 3 (67 criteria were excluded because of redundancy). Criteria with a mean greater than 6 (1 = least appropriate to 9 = most appropriate) were further evaluated by the nominal group technique and provisional core measures were chosen. CONCLUSIONS: Using a Delphi...

  19. Roles and Responsibilities, and Education and Training Requirements for Clinically Qualified Medical Physicists (Spanish Edition)

    International Nuclear Information System (INIS)

    2014-01-01

    The IAEA technical cooperation project Strengthening Medical Physics in Radiation Medicine was approved by the IAEA Board of Governors for the period 2009-2013 with the aim of ensuring the safe and effective diagnosis and treatment of patients. The IAEA, together with the World Health Organization and stakeholders from numerous medical physics professional societies worldwide, including the International Organization for Medical Physics (IOMP), the European Federation of Organisations for Medical Physics, the American Association of Physicists in Medicine (AAPM), the Latin American Medical Physics Association, the Asia-Oceania Federation of Organizations for Medical Physics, the European Society for Radiotherapy and Oncology, the European Commission and the International Radiation Protection Association, as well as regional counterparts from Africa, Asia, Europe and Latin America, met in Vienna in May 2009 to plan and coordinate the new project. A shortage of clinically qualified medical physicists (CQMPs), insufficient education and training (especially properly organized and coordinated clinical training), and lack of professional recognition were identified as the main problems to be addressed under this project. This publication was developed under the project framework in response to these findings. It aims, first, at defining appropriately and unequivocally the roles and responsibilities of a CQMP in specialties of medical physics related to the use of ionizing radiation, such as radiation therapy, nuclear medicine, and diagnostic and interventional radiology. Important, non-ionizing radiation imaging specialties, such as magnetic resonance and ultrasound, are also considered for completeness. On the basis of these tasks, this book provides recommended minimum requirements for the academic education and clinical training of CQMPs, including recommendations for their accreditation, certification and registration, along with continuing professional development

  20. Roles and Responsibilities, and Education and Training Requirements for Clinically Qualified Medical Physicists

    International Nuclear Information System (INIS)

    2013-01-01

    The IAEA technical cooperation project Strengthening Medical Physics in Radiation Medicine was approved by the IAEA Board of Governors for the period 2009-2013 with the aim of ensuring the safe and effective diagnosis and treatment of patients. The IAEA, together with the World Health Organization and stakeholders from numerous medical physics professional societies worldwide, including the International Organization for Medical Physics (IOMP), the European Federation of Organisations for Medical Physics, the American Association of Physicists in Medicine (AAPM), the Latin American Medical Physics Association, the Asia-Oceania Federation of Organizations for Medical Physics, the European Society for Radiotherapy and Oncology, the European Commission and the International Radiation Protection Association, as well as regional counterparts from Africa, Asia, Europe and Latin America, met in Vienna in May 2009 to plan and coordinate the new project. A shortage of clinically qualified medical physicists (CQMPs), insufficient education and training (especially properly organized and coordinated clinical training), and lack of professional recognition were identified as the main problems to be addressed under this project. This publication was developed under the project framework in response to these findings. It aims, first, at defining appropriately and unequivocally the roles and responsibilities of a CQMP in specialties of medical physics related to the use of ionizing radiation, such as radiation therapy, nuclear medicine, and diagnostic and interventional radiology. Important, non-ionizing radiation imaging specialties, such as magnetic resonance and ultrasound, are also considered for completeness. On the basis of these tasks, this book provides recommended minimum requirements for the academic education and clinical training of CQMPs, including recommendations for their accreditation, certification and registration, along with continuing professional development

  1. Role of opsonins in clinical response to granulocyte transfusion in granulocytopenic patients

    International Nuclear Information System (INIS)

    Keusch, G.T.; Ambinder, E.P.; Kovacs, I.; Goldberg, J.D.; Phillips, D.M.; Holland, J.F.

    1982-01-01

    Fifty febrile severely granulocytopenic patients were given four daily transfusions of 2.2 X 10(10) normal donor granulocytes. Twenty-three responded clinically, although both responders and nonresponders were similar in clinical characteristics at the outset. This study examines the relation between serum opsonic activity before initiation of granulocyte administration and clinical response. Opsonic activity to three test organisms (Escherichia coli 286 and ON 2, and Staphylococcus aureus) and to 15 blood stream isolates from 14 patients was measured as serum-dependent uptake of heat-killed 14 C-labeled bacteria by normal donor leukopheresis granulocytes in an in vitro assay and compared with results obtained with a standard normal serum in each assay. At a concentration of 8 percent serum, all patient groups were equivalent to standard for the three test organisms. When rate-limiting concentrations of serum were employed, opsonic activity remained similar to standard for S. aureus in all patient groups and for the two E. coli strains in responders. In contrast, opsonins for E. coli decreased to 41 to 50 percent of standard in nonresponders. When patients with proved infection were separately analyzed, opsonin activity for E. coli was significantly greater in responders than nonresponders. Eight of 10 patients with 75 percent or greater of standard for opsonic activity against their own blood stream isolates also responded, whereas zero of four with less than 75 percent of standard had a favorable outcome. These results indicate that serum opsonic activity may be a determinant of clinical response to granulocyte transfusion in infected granulocytopenic patients. We conclude that opsonic activity should be assessed in such patients before granulocyte administration and suggest a trial of plasma infusion in opsonin-deficient patients

  2. Roles and Responsibilities, and Education and Training Requirements for Clinically Qualified Medical Physicists

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    The IAEA technical cooperation project Strengthening Medical Physics in Radiation Medicine was approved by the IAEA Board of Governors for the period 2009-2013 with the aim of ensuring the safe and effective diagnosis and treatment of patients. The IAEA, together with the World Health Organization and stakeholders from numerous medical physics professional societies worldwide, including the International Organization for Medical Physics (IOMP), the European Federation of Organisations for Medical Physics, the American Association of Physicists in Medicine (AAPM), the Latin American Medical Physics Association, the Asia-Oceania Federation of Organizations for Medical Physics, the European Society for Radiotherapy and Oncology, the European Commission and the International Radiation Protection Association, as well as regional counterparts from Africa, Asia, Europe and Latin America, met in Vienna in May 2009 to plan and coordinate the new project. A shortage of clinically qualified medical physicists (CQMPs), insufficient education and training (especially properly organized and coordinated clinical training), and lack of professional recognition were identified as the main problems to be addressed under this project. This publication was developed under the project framework in response to these findings. It aims, first, at defining appropriately and unequivocally the roles and responsibilities of a CQMP in specialties of medical physics related to the use of ionizing radiation, such as radiation therapy, nuclear medicine, and diagnostic and interventional radiology. Important, non-ionizing radiation imaging specialties, such as magnetic resonance and ultrasound, are also considered for completeness. On the basis of these tasks, this book provides recommended minimum requirements for the academic education and clinical training of CQMPs, including recommendations for their accreditation, certification and registration, along with continuing professional development

  3. Characterizing the inflammatory tissue response to acute myocardial infarction by clinical multimodality noninvasive imaging.

    Science.gov (United States)

    Wollenweber, Tim; Roentgen, Philipp; Schäfer, Andreas; Schatka, Imke; Zwadlo, Caroline; Brunkhorst, Thomas; Berding, Georg; Bauersachs, Johann; Bengel, Frank M

    2014-09-01

    Myocardial infarction (MI) triggers a systemic inflammatory response which determines subsequent healing. Experimentally, cardiac positron emission tomography and magnetic resonance imaging have been used successfully to obtain mechanistic insights. We explored the translational potential in patients early after MI. Positron emission tomography/computed tomography and cardiac magnetic resonance were performed in 15 patients sources of inflammatory cells. Positron emission tomography and cardiac magnetic resonance multimodality characterization of the acutely infarcted, inflamed myocardium may provide multiparametric end points for clinical studies aiming at support of infarct healing. © 2014 American Heart Association, Inc.

  4. X-linked Acrogigantism (X-LAG) Syndrome: Clinical Profile and Therapeutic Responses

    OpenAIRE

    Beckers, Albert; Lodish, Maya Beth; Trivellin, Giampaolo; Rostomyan, Liliya; Lee, Misu; Faucz, Fabio R; Yuan, Bo; Choong, Catherine S; Caberg, Jean-Hubert; Verrua, Elisa; Naves, Luciana Ansaneli; Cheetham, Tim D; Young, Jacques; Lysy, Philippe A; Petrossians, Patrick

    2015-01-01

    X-linked acro-gigantism (X-LAG) is a new syndrome of pituitary gigantism, caused by microduplications on chromosome Xq26.3, encompassing the gene GPR101, which is highly upregulated in pituitary tumors. We conducted this study to explore the clinical, radiological and hormonal phenotype and responses to therapy in patients with X-LAG syndrome. The study included 18 patients (13 sporadic) with X-LAG and a microduplication in chromosome Xq26.3. All sporadic cases had unique duplications and the...

  5. Dependence of alanine gel dosimeter response as a function of photon clinical beams dose rate

    International Nuclear Information System (INIS)

    Silva, Cleber Feijo; Campos, Leticia Lucente

    2013-01-01

    Gel dosimetry is a new area developed by Gore, it is ery useful for application in radiotherapy because using NMR imaging as evaluation technique is possible to evaluate three dimensional absorbed dose distribution. The measure technique is based on difference of ferrous (Fe 2+ ) and ferric (Fe 3+ ) ) ions concentration that can be measured also by spectrophotometry technique. The Alanine gel dosimeter was developed at IPEN. The alanine is an amino acid and tissue equivalent material that presents significant improvement on previous alanine dosimetry systems. The addition of Alanine increases the production of ferric ions in the solution. This work aims to study the dose rate dependence of photon clinical beams radiation on the alanine gel dosimeter optical response, as well as the response repeatability and gel production reproducibility, since this property is very important for characterization and standardization of any dosimeter. (author)

  6. What is the role of the consultant responsible for postgraduate education in the clinical department?

    DEFF Research Database (Denmark)

    Malling, B; Scherpbier, A J J A; Ringsted, C

    2007-01-01

    interviewees expressed a wish for a strong leader at the same time they did not consider the position of the CRE influential. CONCLUSION: Along with improved information about the role of the CRE, formal education, proper job-descriptions and clear leadership in the organisation concerning specialist training......BACKGROUND: The organisation of specialist training is complex and involves many clinical departments. The position of consultants responsible for education (CRE) in specialist training at department level is poorly defined in the literature. AIMS: The aim of the study was to explore expectations...... of stakeholders concerning the role and position of a CRE in specialist training. METHOD: The role and position of the CRE was explored using focus group and semi-structured individual interviews. RESULTS: Knowledge of tasks and responsibilities was limited in all stakeholders except among CREs. The expectations...

  7. Clinical manifestations and treatment response of steroid in pediatric Hashimoto encephalopathy.

    Science.gov (United States)

    Yu, Hee Joon; Lee, Jeehun; Seo, Dae Won; Lee, Munhyang

    2014-07-01

    Hashimoto encephalopathy is a steroid-responsive encephalopathy associated with elevated titers of antithyroid antibodies. Clinical symptoms are characterized by behavioral and cognitive changes, speech disturbance, seizures, myoclonus, psychosis, hallucination, involuntary movements, cerebellar signs, and coma. The standard treatment is the use of corticosteroids along with the treatment of any concurrent dysthyroidism. Other options are immunoglobulins and plasmapheresis. We described symptoms and outcomes on 3 teenage girls with Hashimoto encephalopathy. Presenting symptoms were seizure or altered mental status. One patient took levothyroxine due to hypothyroidism before presentation of Hashimoto encephalopathy. After confirmation of elevated antithyroid antibodies, all patients were treated with steroids. One patient needed plasmapheresis because of the lack of response to steroids and immunoglobulins. Hashimoto encephalopathy should be considered in any patient presenting with acute or subacute unexplained encephalopathy and seizures. Even though the use of steroids is the first line of treatment, plasmapheresis can rescue steroid-resistant patients. © The Author(s) 2013.

  8. When bad guys become good ones: the key role of reactive oxygen species and nitric oxide in the plant responses to abiotic stress

    Directory of Open Access Journals (Sweden)

    Fernanda Dos Santos Farnese

    2016-04-01

    Full Text Available The natural environment of plants is composed of a complex set of abiotic stresses and their ability to respond to these stresses is highly flexible and finely balanced through the interaction between signaling molecules. In this review, we highlight the integrated action between reactive oxygen species (ROS and reactive nitrogen species (RNS, particularly nitric oxide (NO, involved in the acclimation to different abiotic stresses. Under stressful conditions, the biosynthesis transport and the metabolism of ROS and NO influence plant response mechanisms. The enzymes involved in ROS and NO synthesis and scavenging can be found in different cells compartments and their temporal and spatial locations are determinant for signaling mechanisms. Both ROS and NO are involved in long distances signaling (ROS wave and GSNO transport, promoting an acquired systemic acclimation to abiotic stresses. The mechanisms of abiotic stresses response triggered by ROS and NO involve some general steps, as the enhancement of antioxidant systems, but also stress-specific mechanisms, according to the stress type (drought, hypoxia, heavy metals, etc, and demand the interaction with other signaling molecules, such as MAPK, plant hormones and calcium. The transduction of ROS and NO bioactivity involves post-translational modifications of proteins, particularly S-glutathionylation for ROS, and S-nitrosylation for NO. These changes may alter the activity, stability, and interaction with other molecules or subcellular location of proteins, changing the entire cell dynamics and contributing to the maintenance of homeostasis. However, despite the recent advances about the roles of ROS and NO in signaling cascades, many challenges remain, and future studies focusing on the signaling of these molecules in planta are still necessary.

  9. When Bad Guys Become Good Ones: The Key Role of Reactive Oxygen Species and Nitric Oxide in the Plant Responses to Abiotic Stress.

    Science.gov (United States)

    Farnese, Fernanda S; Menezes-Silva, Paulo E; Gusman, Grasielle S; Oliveira, Juraci A

    2016-01-01

    The natural environment of plants is composed of a complex set of abiotic stresses and their ability to respond to these stresses is highly flexible and finely balanced through the interaction between signaling molecules. In this review, we highlight the integrated action between reactive oxygen species (ROS) and reactive nitrogen species (RNS), particularly nitric oxide (NO), involved in the acclimation to different abiotic stresses. Under stressful conditions, the biosynthesis transport and the metabolism of ROS and NO influence plant response mechanisms. The enzymes involved in ROS and NO synthesis and scavenging can be found in different cells compartments and their temporal and spatial locations are determinant for signaling mechanisms. Both ROS and NO are involved in long distances signaling (ROS wave and GSNO transport), promoting an acquired systemic acclimation to abiotic stresses. The mechanisms of abiotic stresses response triggered by ROS and NO involve some general steps, as the enhancement of antioxidant systems, but also stress-specific mechanisms, according to the stress type (drought, hypoxia, heavy metals, etc.), and demand the interaction with other signaling molecules, such as MAPK, plant hormones, and calcium. The transduction of ROS and NO bioactivity involves post-translational modifications of proteins, particularly S-glutathionylation for ROS, and S-nitrosylation for NO. These changes may alter the activity, stability, and interaction with other molecules or subcellular location of proteins, changing the entire cell dynamics and contributing to the maintenance of homeostasis. However, despite the recent advances about the roles of ROS and NO in signaling cascades, many challenges remain, and future studies focusing on the signaling of these molecules in planta are still necessary.

  10. Eggs: good or bad?

    Science.gov (United States)

    Griffin, Bruce A

    2016-08-01

    Eggs have one of the lowest energy to nutrient density ratios of any food, and contain a quality of protein that is superior to beef steak and similar to dairy. From a nutritional perspective, this must qualify eggs as 'good'. The greater burden of proof has been to establish that eggs are not 'bad', by increasing awareness of the difference between dietary and blood cholesterol, and accumulating sufficient evidence to exonerate eggs from their associations with CVD and diabetes. After 60 years of research, a general consensus has now been reached that dietary cholesterol, chiefly from eggs, exerts a relatively small effect on serum LDL-cholesterol and CVD risk, in comparison with other diet and lifestyle factors. While dietary guidelines have been revised worldwide to reflect this view, associations between egg intake and the incidence of diabetes, and increased CVD risk in diabetes, prevail. These associations may be explained, in part, by residual confounding produced by other dietary components. The strength of evidence that links egg intake to increased CVD risk in diabetes is also complicated by variation in the response of serum LDL-cholesterol to eggs and dietary cholesterol in types 1 and 2 diabetes. On balance, the answer to the question as to whether eggs are 'bad', is probably 'no', but we do need to gain a better understanding of the effects of dietary cholesterol and its association with CVD risk in diabetes.

  11. Radiological response and clinical outcome in patients with femoral bone metastases after radiotherapy

    International Nuclear Information System (INIS)

    Harada, Hideyuki; Katagiri, Hirohisa; Kamata, Minoru

    2010-01-01

    We evaluated the radiological response and clinical outcome in patients with femoral bone metastases after radiotherapy. 102 consecutive patients with femoral metastases without pathological fracture were treated by surgery or radiotherapy between 2002 and 2005. Twelve of them initially treated with surgery were excluded from this study. The remaining 90 patients with 102 lesions underwent radiation therapy as the initial treatment. Twelve patients who died within 30 days by disease progression and 6 who were lost to follow-up were excluded. The remaining 72 patients with 84 lesions including 43 impending fractures were enrolled in this analysis. Radiological changes were categorized into complete response, partial response, no change, and progressive disease based on plain radiograph findings. Pain relief was reviewed for 77 painful lesions. The median radiation dose was 30 Gy. No re-irradiation was performed. 35 lesions (42%) achieved radiological responses median 3 months after radiotherapy. Pain relief was obtained in 36 of 77 lesions (47%). There was no significant correlation between radiological response and pain relief (P=0.166). Eleven lesions eventually required surgery and considered as treatment failure. The treatment failure rate in the radiological progressive disease (PD) group (8/19, 42%) was significantly higher than that in the non-PD group (3/65, 5%) (P<0.001). Among 43 impending fracture lesions, 15 lesions (36%) experienced radiological response and 35 lesions (81%) required no surgical interventions. Our data suggest that radiotherapy can enable metastatic bone healing and avoid surgery in many lesions. However, radiological PD lesions often require surgery after radiotherapy. (author)

  12. Clinical Manifestations of an Anti-Drug Antibody Response: Autoimmune Reactions.

    Science.gov (United States)

    Swanson, Steven J

    2014-12-01

    Antibodies can be generated against a therapeutic protein upon administration to human subjects. When the therapeutic protein closely mimics one of the subject's endogenous proteins, those antibodies might bind to the endogenous protein in addition to the therapeutic protein. This scenario results when tolerance to the endogenous protein is broken. The consequences of breaking tolerance include an autoimmune response where antibodies are generated against the endogenous protein. These autoantibodies could have significant clinical relevance depending on several factors, including the redundancy of action of the endogenous protein as well as the concentration, binding affinity, and neutralizing potential of the antibodies. The consequences of a therapeutic-protein-induced autoimmune reaction can be challenging to manage as the stimulus for further perpetuation of the immune response can shift from the therapeutic protein to the endogenous protein. The potential for inducing an autoimmune response is one of the reasons that the immune response to a therapeutic protein should be monitored if it persists through the end of the study.

  13. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation.

    Science.gov (United States)

    Williams, Valerie J; Piva, Sara R; Irrgang, James J; Crossley, Chad; Fitzgerald, G Kelley

    2012-08-01

    Secondary analysis, pretreatment-posttreatment observational study. To compare the reliability and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Outcome Survey activities of daily living subscale (KOS-ADL), and the Lower Extremity Functional Scale (LEFS) in individuals with knee osteoarthritis (OA). The WOMAC is the current standard in patient-reported measures of function in patients with knee OA. The KOS-ADL and LEFS were designed for potential use in patients with knee OA. If the KOS-ADL and LEFS are to be considered viable alternatives to the WOMAC for measuring patient-reported function in individuals with knee OA, they should have measurement properties comparable to the WOMAC. It would also be important to determine whether either of these instruments may be superior to the WOMAC in terms of reliability or responsiveness in this population. Data from 168 subjects with knee OA, who participated in a rehabilitation program, were used in the analyses. Reliability and responsiveness of each outcome measure were estimated at follow-ups of 2, 6, and 12 months. Reliability was estimated by calculating the intraclass correlation coefficient (ICC2,1) for subjects who were unchanged in status from baseline at each follow-up time, based on a global rating of change score. To examine responsiveness, the standard error of the measurement, minimal detectable change, minimal clinically important difference, and the Guyatt responsiveness index were calculated for each outcome measure at each follow-up time. All 3 outcome measures demonstrated reasonable reliability and responsiveness to change. Reliability and responsiveness tended to decrease somewhat with increasing follow-up time. There were no substantial differences between outcome measures for reliability or any of the 3 measures of responsiveness at any follow-up time. The results do not indicate that one outcome measure is more reliable or responsive than

  14. Identifying clinically meaningful symptom response cut-off values on the SANS in predominant negative symptoms.

    Science.gov (United States)

    Levine, Stephen Z; Leucht, Stefan

    2013-04-01

    The treatment and measurement of negative symptoms are currently at issue in schizophrenia, but the clinical meaning of symptom severity and change is unclear. To offer a clinically meaningful interpretation of severity and change scores on the Scale for the Assessment of Negative Symptoms (SANS). Patients were intention-to-treat participants (n=383) in two double-blind randomized placebo-controlled clinical trials that compared amisulpride with placebo for the treatment of predominant negative symptoms. Equipercentile linking was used to examine extrapolation from (a) CGI-S to SANS severity ratings, and (b) CGI-I to SANS percentage change (n=383). Linking was conducted at baseline, 8-14 days, 28-30 days, and 56-60 days of the trials. Across visits, CGI-S ratings of 'not ill' linked to SANS scores of 0-13, and ranged to 'extreme' ratings that linked to SANS scores of 102-105. The relationship between the CGI-S and the SANS severity scores assumed a linear trend (1=0-13, 2=15-56, 3=37-61, 4=49-66, 5=63-75, 6=79-89, 7=102-105). Similarly the relationship between CGI-I ratings and SANS percentage change followed a linear trend. For instance, CGI-I ratings of 'very much improved' were linked to SANS percent changes of -90 to -67, 'much improved' to -50 to -42, and 'minimally improved' to -21 to -13. The current results uniquely contribute to the debate surrounding negative symptoms by providing clinical meaning to SANS severity and change scores and so offer direction regarding clinically meaningful response cut-off scores to guide treatment targets of predominant negative symptoms. Copyright © 2013 Elsevier B.V. All rights reserved.

  15. Response surface methodology approach for the optimisation of adsorption of hydrolysed polyacrylamide from polymer-flooding wastewater onto steel slag: a good option of waste mitigation.

    Science.gov (United States)

    Zhu, Mijia; Yao, Jun; Qin, Zhonghai; Lian, Luning; Zhang, Chi

    2017-08-01

    Wastewater produced from polymer flooding in oil production features high viscosity and chemical oxygen demand because of the residue of high-concentration polymer hydrolysed polyacrylamide (HPAM). In this study, steel slag, a waste from steel manufacturing, was studied as a low-cost adsorbent for HPAM in wastewater. Optimisation of HPAM adsorption by steel slag was performed with a central composite design under response surface methodology (RSM). Results showed that the maximum removal efficiency of 89.31% was obtained at an adsorbent dosage of 105.2 g/L, contact time of 95.4 min and pH of 5.6. These data were strongly correlated with the experimental values of the RSM model. Single and interactive effect analysis showed that HPAM removal efficiency increased with increasing adsorbent dosage and contact time. Efficiency increased when pH was increased from 2.6 to 5.6 and subsequently decreased from 5.6 to 9.3. It was observed that removal efficiency significantly increased (from 0% to 86.1%) at the initial stage (from 0 min to 60 min) and increased gradually after 60 min with an adsorbent dosage of 105.2 g/L, pH of 5.6. The adsorption kinetics was well correlated with the pseudo-second-order equation. Removal of HPAM from the studied water samples indicated that steel slag can be utilised for the pre-treatment of polymer-flooding wastewater.

  16. Cross-talk between Clinical and Host Response Parameters of Periodontitis in Smokers

    Science.gov (United States)

    Nagarajan, R.; Miller, C.S.; Dawson, D.; Al-Sabbagh, M.; Ebersole, J.L.

    2016-01-01

    Periodontal diseases are a major public health concern leading to tooth loss and also shown to be associated with several chronic systemic diseases. Smoking is a major risk factor for developing numerous systemic diseases, as well as periodontitis. While it is clear that smokers have a significantly enhanced risk for developing periodontitis leading to tooth loss, the population varies with regards to susceptibility to disease associated with smoking. This investigation focuses on identifying differences in four broad sets of variables consisting of: (a) host response molecules, (b) periodontal clinical parameters, (c) antibody measures for periodontal pathogens and oral commensal bacteria challenge, and (d) other variables of interest in a smoking population with (n = 171) and without periodontitis (n = 117). Subsequently, Bayesian network structured learning techniques (BNSL) techniques were used to investigate potential associations and cross-talk between the four broad sets of variables. BNSL revealed two broad communities with markedly different topology between the non-periodontitis and periodontitis smoking population. Confidence of the edges in the resulting network also showed marked variations within and between the periodontitis and non-periodontitis groups. The results presented validated known associations, as well as discovered new ones with minimal precedence that may warrant further investigation and novel hypothesis generation. Cross-talk between the clinical variables and antibody profiles of bacteria were especially pronounced in the case of periodontitis and mediated by the antibody response profile to P. gingivalis. PMID:27431617

  17. Immunological monitoring for prediction of clinical response to antitumor vaccine therapy.

    Science.gov (United States)

    Mikhaylova, Irina N; Shubina, Irina Zh; Chkadua, George Z; Petenko, Natalia N; Morozova, Lidia F; Burova, Olga S; Beabelashvili, Robert Sh; Parsunkova, Kermen A; Balatskaya, Natalia V; Chebanov, Dmitrii K; Pospelov, Vadim I; Nazarova, Valeria V; Vihrova, Anastasia S; Cheremushkin, Evgeny A; Molodyk, Alvina A; Kiselevsky, Mikhail V; Demidov, Lev V

    2018-05-11

    Immunotherapy has shown promising results in a variety of cancers, including melanoma. However, the responses to therapy are usually heterogeneous, and understanding the factors affecting clinical outcome is still not achieved. Here, we show that immunological monitoring of the vaccine therapy for melanoma patients may help to predict the clinical course of the disease. We studied cytokine profile of cellular Th1 (IL-2, IL-12, IFN-γ) and humoral Th2 (IL-4, IL-10) immune response, vascular endothelial growth factor (VEGFA), transforming growth factor-β 2 (TGF-β 2), S100 protein (S100A1B and S100BB), adhesion molecule CD44 and serum cytokines β2-microglobulin to analyze different peripheral blood mononuclear cell subpopuations of patients treated with dendritic vaccines and/or cyclophosphamide in melanoma patients in the course of adjuvant treatment. The obtained data indicate predominance of cellular immunity in the first adjuvant group of patients with durable time to progression and shift to humoral with low cellular immunity in patients with short-term period to progression (increased levels of IL-4 and IL- 10). Beta-2 microglobulin was differentially expressed in adjuvant subgroups: its higher levels correlated with shorter progression-free survival and the total follow-up time. Immunoregulatory index was overall higher in patients with disease progression compared to the group of patients with no signs of disease progression.

  18. Bread Affects Clinical Parameters and Induces Gut Microbiome-Associated Personal Glycemic Responses.

    Science.gov (United States)

    Korem, Tal; Zeevi, David; Zmora, Niv; Weissbrod, Omer; Bar, Noam; Lotan-Pompan, Maya; Avnit-Sagi, Tali; Kosower, Noa; Malka, Gal; Rein, Michal; Suez, Jotham; Goldberg, Ben Z; Weinberger, Adina; Levy, Avraham A; Elinav, Eran; Segal, Eran

    2017-06-06

    Bread is consumed daily by billions of people, yet evidence regarding its clinical effects is contradicting. Here, we performed a randomized crossover trial of two 1-week-long dietary interventions comprising consumption of either traditionally made sourdough-leavened whole-grain bread or industrially made white bread. We found no significant differential effects of bread type on multiple clinical parameters. The gut microbiota composition remained person specific throughout this trial and was generally resilient to the intervention. We demonstrate statistically significant interpersonal variability in the glycemic response to different bread types, suggesting that the lack of phenotypic difference between the bread types stems from a person-specific effect. We further show that the type of bread that induces the lower glycemic response in each person can be predicted based solely on microbiome data prior to the intervention. Together, we present marked personalization in both bread metabolism and the gut microbiome, suggesting that understanding dietary effects requires integration of person-specific factors. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Susceptibility of functional impairment scales to noncredible responses in the clinical evaluation of adult ADHD.

    Science.gov (United States)

    Fuermaier, Anselm B M; Tucha, Oliver; Koerts, Janneke; Butzbach, Marah; Weisbrod, Matthias; Aschenbrenner, Steffen; Tucha, Lara

    2018-05-01

    A growing body of research questions the reliance of symptom self-reports in the clinical evaluation of attention-deficit/hyperactivity disorder (ADHD) in adulthood. A recent study suggested that also impairment reports are vulnerable to noncredible responses, as derived from a simulation design using a global functional impairment scale. The present study aims to add evidence to this issue, by using an ADHD specific impairment scale in a simulation design on large samples. Impairment ratings on the Weiss Functional Impairment Rating Scale (WFIRS) of 62 patients with ADHD were compared to 142 healthy individuals who were instructed to show normal behavior. Furthermore, impairment ratings of patients with ADHD were compared to ratings of 330 healthy individuals who were randomly assigned to one of four simulation conditions that were instructed to complete the scale as if they had ADHD. Patients with ADHD reported higher levels of impairment than the healthy control group in all domains of life. Furthermore, individuals instructed to feign ADHD indicated higher levels of impairments in most domains of life compared to control participants and genuine patients with ADHD. The group differences between individuals feigning ADHD and individuals with genuine ADHD, however, were only small to moderate. Further analyses revealed that the WFRIS was not useful to successfully differentiate genuine from feigned ADHD. The present study confirms the conclusion that self-reported impairments are susceptible to noncredible responses and should be used with caution in the clinical evaluation of adult ADHD.

  20. Psychometric properties of the Ruminative Response Scale-short form in a clinical sample of patients with major depressive disorder

    Directory of Open Access Journals (Sweden)

    Parola N

    2017-05-01

    Full Text Available Nathalie Parola,1,2,* Xavier Yves Zendjidjian,1,3,* Marine Alessandrini,1 Karine Baumstarck,1 Anderson Loundou,1 Guillaume Fond,4,5 Fabrice Berna,4,6 Christophe Lançon,1–3 Pascal Auquier,1 Laurent Boyer1 1Public Health, Chronic Diseases and Quality of Life – Research Unit EA 3279, Aix-Marseille University, Marseille, 2Department of Psychiatry, Sainte-Marguerite University Hospital, Marseille, 3Department of Psychiatry, La Conception University Hospital, Marseille, 4Fondation FondaMental, Créteil, 5Department of Psychiatry and Addictology, Henri Mondor University Hospital, INSERM U955, Eq 15 Genetic Psychiatry and Psychopathology, Paris Est-Créteil University, Créteil, 6Department of Psychiatry, INSERM U1114, Fédération de Médecine Translationnelle de Strasbourg, Strasbourg University Hospital, Strasbourg, France *These authors contributed equally to this work Background: The Ruminative Response Scale (RRS-short form is one of the most widely used measures of rumination, comprising ten items and two components: reflection and brooding. The aim of this study was to investigate RRS validity and reliability in a clinical sample of French patients with major depressive disorder (MDD.Subjects and methods: Outpatients with a DSM-IV-TR diagnosis of MDD were recruited from a public academic hospital in France. Depressive symptoms were evaluated by the Beck Depression Inventory, anxiety by the State-Trait Anxiety Inventory – state scale, and quality of life by the 36-Item Short Form Health Survey (SF-36 questionnaire. Confirmatory factor analyses, item-dimension correlations, Cronbach’s α-coefficients, Rasch statistics, and external validity were tested. Differential item functioning analyses were performed for sex.Results: A total of 109 patients participated. The final reflection–brooding two-factor model of the RRS showed a good fit (root-mean-square error of approximation 0.041, comparative fit index 0.987, standardized root

  1. The common good

    OpenAIRE

    Argandoña, Antonio

    2011-01-01

    The concept of the common good occupied a relevant place in classical social, political and economic philosophy. After losing ground in the Modern age, it has recently reappeared, although with different and sometimes confusing meanings. This paper is the draft of a chapter of a Handbook; it explains the meaning of common good in the Aristotelian-Thomistic philosophy and in the Social Doctrine of the Catholic Church; why the common good is relevant; and how it is different from the other uses...

  2. Analysis of clinical factors for pathological complete response after preoperative neoadjuvant chemoradiotherapy for rectal cancer

    International Nuclear Information System (INIS)

    Ayiguli Hare; Palida Apizi; Iskandar Abulimiti; Zhang Jinrong; Tian Hanhan

    2014-01-01

    Objective: To evaluate the clinical factors associated with pathological complete response (pCR) after preoperative neoadjuvant chemoradiotherapy for rectal cancer. Methods: A retrospective analysis was performed on the clinical data of 116 patients with rectal cancer, who underwent neoadjuvant chemoradiotherapy followed by radical surgery from January 2009 to December 2012. All patients received pelvic intensity-modulated radiotherapy (50 Gy/25 fractions) with concurrent fluorouracil based chemotherapy and then underwent radical surgery 4-8 weeks later. The clinical factors associated with pCR or non-pCR were analyzed by Logistic regression. Results: Of the 116 patients, 20 (17.2%) achieved a pCR after neoadjuvant chemoradiotherapy. The univariate analysis showed that percentage of circumference of the rectal tube invaded by the tumor, preoperative serum carcinoembryonic antigen (CEA) level, T stage, N stage, distance from the anal verge, degree of tumor differentiation, and maximum tumor diameter were associated with pCR or non-pCR after neoadjuvant chemoradiotherapy for rectal cancer. The multivariate analysis revealed that percentage of circumference of the rectal tube invaded by the tumor, preoperative serum CEA level,and T stage were predictive factors for pCR or non-pCR after neoadjuvant chemoradiotherapy for rectal cancer. Conclusions: Non-circumferential tumor (percentage of circumference of the rectal tube invaded by the tumor <75 %), low CEA level, and early T stage before treatment may be associated with pCR after neoadjuvant chemoradiotherapy for rectal cancer. (authors)

  3. Assessment of the response of tumours to radiation: clinical and experimental studies

    International Nuclear Information System (INIS)

    Suit, H.D.; Walker, A.M.

    1980-01-01

    There is an important and active research programme at the laboratory and clinical level to develop indicators of the ultimate local response of tumours to radiation. In order to be of great value clinically indicators should yield a high true positivity and a low false positivity so that revisions of therapeutic strategy will be made only when there is a real need for such a change. The available data in the literature from the clinical studies, when analysed in terms of the true and false positive rates, indicate that the extent of regression at the completion of external beam therapy is not a useful prognostic indicator. This pertains to populations of tumour of a specific histopathological type, tumour size and anatomic site. Studies of laboratory animal tumour models have shown that regression patterns may be useful prognostic indicators for a tumour which is characterized by moderate immunogenicity and where there is close correlation between complete regression and permanent control. In contrast for tumours which are weakly or nonimmunogenic and which regress completely even at low tumour control probabilities, the pattern of regression has not been demonstrated to be of prognostic value. (author)

  4. Lens Dk/t influences the clinical response in overnight orthokeratology.

    Science.gov (United States)

    Lum, Edward; Swarbrick, Helen A

    2011-04-01

    To investigate the influence of lens oxygen transmissibility (Dk/t) on the clinical response to overnight (ON) orthokeratology (OK) lens wear over 2 weeks. Eleven subjects (age, 20 to 39 years) were fitted with OK lenses (BE; Capricornia Contact Lens) in both eyes. Lenses in matched design/fitting but different materials (Boston EO and XO; nominal Dk/t: 26 and 46 ISO Fatt, respectively) were worn ON only in the two eyes over a 2-week period. Changes in logarithm of the minimum angle of resolution visual acuity, subjective refraction (spherical equivalent), corneal apical radius ro and asphericity Q (Medmont E300), and central stromal thickness (Holden-Payor optical pachometer) were measured. There were statistically significant differences in outcomes between the two lens materials (analysis of variance, p 0.05). An increase in lens Dk/t appears to increase the clinical effects of ON reverse-geometry lens wear over the medium term. This adds further support to the recommendation that high Dk materials should be used for ON OK not only to provide physiological advantages but also to optimize clinical outcomes.

  5. How Iranian Medical Trainees Approach their Responsibilities in Clinical Settings; A Grounded Theory Research

    Directory of Open Access Journals (Sweden)

    Omid Asemani

    2015-09-01

    Full Text Available Background: It seems we are now experiencing “responsibility problems” among medical trainees (MTs and some of those recently graduated from medical schools in Iran. Training responsible professionals have always been one of the main concerns of medical educators. Nevertheless, there is a dearth of research in the literature on “responsibility” especially from the medical education point of view. Therefore, the present study was carried out with the aim of presenting a theoretical based framework for understanding how MTs approach their responsibilities in educational settings. Method: This qualitative study was conducted at Shiraz University of Medical Sciences (SUMS using the grounded theory methodology. 15 MTs and 10 clinical experts and professional nurses were purposefully chosen as participants. Data was analyzed using the methodology suggested by Corbin and Strauss, 1998. Results: “Try to find acceptance toward expectations”, “try to be committed to meet the expectations” and “try to cope with unacceptable expectations” were three main categories extracted based on the research data. Abstractly, the main objective for using these processes was “to preserve the integrity of student identity” which was the core category of this research too. Moreover, it was also found that practically, “responsibility” is considerably influenced by lots of positive and negative contextual and intervening conditions. Conclusion: “Acceptance” was the most decisive variable highly effective in MTs’ responsibility. Therefore, investigating the “process of acceptance” regarding the involved contextual and intervening conditions might help medical educators correctly identify and effectively control negative factors and reinforce the constructive ones that affect the concept of responsibility in MTs.

  6. Pharmacogenetic markers to predict the clinical response to methotrexate in south Indian Tamil patients with psoriasis.

    Science.gov (United States)

    Indhumathi, S; Rajappa, Medha; Chandrashekar, Laxmisha; Ananthanarayanan, P H; Thappa, D M; Negi, V S

    2017-08-01

    Despite the advent of several new systemic therapies, methotrexate remains the gold standard for the treatment of moderate to severe psoriasis. However, there exists a significant heterogeneity in individual response to methotrexate. There are no consistently reliable markers to predict methotrexate treatment response till date. We aimed to demonstrate the association of certain genetic variants in the HLA (HLA-A2, HLA-B17, and HLA-Cw6) and the non-HLA genes including T-helper (Th)-1, Th-2, Th-17 cytokine genes (IFN-γ, IL-2, IL-4, IL-10, IL-12B, and IL-23R), and T-regulatory gene (FOXP3) with the methotrexate treatment response in South Indian Tamil patients with psoriasis. Of the 360 patients recruited, 189 patients with moderate to severe psoriasis were treated with methotrexate. Of the 189 patients, 132 patients responded to methotrexate and the remaining 57 patients were non-responders. We analyzed the association of aforesaid polymorphisms with the methotrexate treatment outcome using binary logistic regression. We observed that there were significant differences between genotype frequencies of HLA-Cw6 and FOXP3 (rs3761548) among the responders compared to non-responders, with conservative estimation. We observed that pro-inflammatory cytokines such as IFN-γ, IL-2, IL-12, and IL-23 were markedly reduced with the use of methotrexate, in comparison to the baseline levels, while the plasma IL-4 levels were increased posttreatment. Our results serve as preliminary evidence for the clinical use of genetic markers as predictors of response to methotrexate in psoriasis. This might aid in the future in the development of a point-of-care testing (POCT) gene chip, to predict optimal treatment response in patients with psoriasis, based on their individual genotypic profile.

  7. Clinical factors associated with the humoral immune response to influenza vaccination in chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Nath KD

    2013-12-01

    Full Text Available Karthik D Nath,1,2 Julie G Burel,1 Viswanathan Shankar,3 Antonia L Pritchard,1 Michelle Towers,2 David Looke,1,2 Janet M Davies,1 John W Upham1,2 1The University of Queensland (School of Medicine, Brisbane, QLD, Australia; 2Princess Alexandra Hospital, Brisbane, QLD, Australia; 3Department of Epidemiology and Population Health, Albert Einstein College of Medicine, New York, NY, USA Background and objective: Individuals with chronic obstructive pulmonary disease (COPD are at a high risk of developing significant complications from infection with the influenza virus. It is therefore vital to ensure that prophylaxis with the influenza vaccine is effective in COPD. The aim of this study was to assess the immunogenicity of the 2010 trivalent influenza vaccine in persons with COPD compared to healthy subjects without lung disease, and to examine clinical factors associated with the serological response to the vaccine. Methods: In this observational study, 34 subjects (20 COPD, 14 healthy received the 2010 influenza vaccine. Antibody titers at baseline and 28 days post-vaccination were measured using the hemagglutination inhibition assay (HAI assay. Primary endpoints included seroconversion (≥4-fold increase in antibody titers from baseline and the fold increase in antibody titer after vaccination. Results: Persons with COPD mounted a significantly lower humoral immune response to the influenza vaccine compared to healthy participants. Seroconversion occurred in 90% of healthy participants, but only in 43% of COPD patients (P=0.036. Increasing age and previous influenza vaccination were associated with lower antibody responses. Antibody titers did not vary significantly with cigarette smoking, presence of other comorbid diseases, or COPD severity. Conclusion: The humoral immune response to the 2010 influenza vaccine was lower in persons with COPD compared to non-COPD controls. The antibody response also declined with increasing age and in those with

  8. Maternal-fetal acute responses to two moderate-intensity exercise types: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Jousilene de Sales Tavares

    2018-03-01

    Full Text Available Objective:  This study aims to compare maternal and fetal responses during two physical exercise types. Design:  A randomized clinical trial compared 120 pregnant women, gestational age of 35-37 weeks, 56 exercising on a stationary bicycle (Group A and 64 on a treadmill (Group B. Methods: Participants were monitored for three 20-minute phases: resting, exercise and recovery.  Fetal heart rate (FHR and maternal heart rate (MHR were monitored.  Glucose and lactate levels were evaluated at rest and during exercise. Results:  After the beginning of exercise, maximum lactate (L levels were reached at 20 minutes and never exceeded 4 mmol/l.  FHR decreased by 22 bpm during exercise in relation to resting values, irrespective of the exercise type (p0.05, increasing at 20’ to 32% and 40.6%, respectively, (p>0.05.  The FHR decrease during exercise was accompanied by a simultaneous increase in its variability (p<0.001, nevertheless a rapid return to resting values was observed shortly after exercise end.  Glucose decreased in both groups irrespective of the exercise type (85 mg/dl at rest; 79 mg/dl during exercise and 81 mg/dl during recovery; p<0.001. There were no hypoglycemia cases. Conclusions: FHR variability increase and the rapid return to resting values after exercise suggests that the FHR fall and the presence of bradycardia during exercise is the fetal physiologic response to blood flow redistribution, with maintenance of fetal well-being. Key-words: Exercise; fetal heart rate; glucose; maternal heart rate; pregnancy Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01383889.

  9. Transport of hazardous goods

    International Nuclear Information System (INIS)

    1989-01-01

    The course 'Transport of hazardous goods' was held in Berlin in November 1988 in cooperation with the Bundesanstalt fuer Materialforschung und -pruefung. From all lecturs, two are recorded separately: 'Safety of tank trucks - requirements on the tank, development possibiities of active and passive safety' and 'Requirements on the transport of radioactive materials - possible derivations for other hazardous goods'. The other lectures deal with hazardous goods law, requirements on packinging, risk assessment, railroad transport, hazardous goods road network, insurance matters, EC regulations, and waste tourism. (HSCH) [de

  10. On good ETOL forms

    DEFF Research Database (Denmark)

    Skyum, Sven

    1978-01-01

    This paper continues the study of ETOL forms and good EOL forms done by Maurer, Salomaa and Wood. It is proven that binary very complete ETOL forms exist, good synchronized ETOL forms exist and that no propagating or synchronized ETOL form can be very complete.......This paper continues the study of ETOL forms and good EOL forms done by Maurer, Salomaa and Wood. It is proven that binary very complete ETOL forms exist, good synchronized ETOL forms exist and that no propagating or synchronized ETOL form can be very complete....

  11. On Having a Good

    OpenAIRE

    Korsgaard, Christine M.

    2014-01-01

    In some recent papers I have been arguing that the concept ‘good-for’ is prior to the concept of ‘good’ (in the sense in which final ends are good), and exploring the implications of that claim. One of those implications is that everything that is good is good for someone. That implication seems to fall afoul of our intuitions about certain cases, such as the intuition that a world full of happy people and animals is better than a world full of miserable ones, even if the people and animals a...

  12. Good Mental Health

    Science.gov (United States)

    ... the Eating Disorders Clinical and Research Program, Massachusetts General Hospital Kendra Becker, M.S., Clinical Fellow in Psychology, Department of Psychiatry, Massachusetts General Hospital Michael Kozak, ...

  13. A multicentre, clinical evaluation of a hydro-responsive wound dressing: the Glasgow experience.

    Science.gov (United States)

    Hodgson, H; Davidson, D; Duncan, A; Guthrie, J; Henderson, E; MacDiarmid, M; McGown, K; Pollard, V; Potter, R; Rodgers, A; Wilson, A; Horner, J; Doran, M; Simm, S; Taylor, R; Rogers, A; Rippon, M G; Colgrave, M

    2017-11-02

    Our aim was to assess the effectiveness of hydro-responsive wound dressing (HRWD) in debridement and wound bed preparation of a variety of acute and chronic wounds that presented with devitalised tissue needing removal so that healing may proceed. This was a non-comparative evaluation of acute and chronic wounds that required debridement as part of their normal treatment regimen. Clinicians recorded wound changes including a subjective assessment level of devitalised tissue and wound bed preparation, presence of pain, wound status (e.g., wound size) and periwound skin condition. Data was also collected from clinicians and patients to provide information on clinical performance of the dressing. We recruited 100 patients with a variety of wound types into the study. Over 90% of the clinicians reported removal of devitalised tissue to enable a healing response in both chronic and acute wounds. Specifically, over the course of the evaluation period, levels of devitalised tissue (necrosis and slough) reduced from 85.5% to 26.3%, and this was accompanied by an increase in wound bed granulation from 12.0% to 33.7%. Correspondingly, there was a 40% reduction in wound area, hence a clinically relevant healing response was seen upon treatment with HRWD. It is also noteworthy that this patient population included a significant proportion of chronic wounds (51.4%) that showed no signs of wound progression within debridement process (£8.05), larval therapy (£306.39) and mechanical pad debridement (£11.46). HRWD was well tolerated and was demonstrated to be an efficient debridement tool providing rapid, effective and pain free debridement in a variety of wound types.

  14. A 'joint venture' model of recontacting in clinical genomics: challenges for responsible implementation.

    Science.gov (United States)

    Dheensa, Sandi; Carrieri, Daniele; Kelly, Susan; Clarke, Angus; Doheny, Shane; Turnpenny, Peter; Lucassen, Anneke

    2017-07-01

    Advances in genomics often lead healthcare professionals (HCPs) to learn new information, e.g., about reinterpreted variants that could have clinical significance for patients seen previously. A question arises of whether HCPs should recontact these former patients. We present some findings interrogating the views of patients (or parents of patients) with a rare or undiagnosed condition about how such recontacting might be organised ethically and practically. Forty-one interviews were analysed thematically. Participants suggested a 'joint venture' model in which efforts to recontact are shared with HCPs. Some proposed an ICT-approach involving an electronic health record that automatically alerts them to potentially relevant updates. The need for rigorous privacy controls and transparency about who could access their data was emphasised. Importantly, these findings highlight that the lack of clarity about recontacting is a symptom of a wider problem: the lack of necessary infrastructure to pool genomic data responsibly, to aggregate it with other health data, and to enable patients/parents to receive updates. We hope that our findings will instigate a debate about the way responsibilities for recontacting under any joint venture model could be allocated, as well as the limitations and normative implications of using ICT as a solution to this intractable problem. As a first step to delineating responsibilities in the clinical setting, we suggest HCPs should routinely discuss recontacting with patients/parents, including the new information that should trigger a HCP to initiate recontact, as part of the consent process for genetic testing. Copyright © 2017 The Authors. Published by Elsevier Masson SAS.. All rights reserved.

  15. TNFRSF14 aberrations in follicular lymphoma increase clinically significant allogeneic T-cell responses.

    Science.gov (United States)

    Kotsiou, Eleni; Okosun, Jessica; Besley, Caroline; Iqbal, Sameena; Matthews, Janet; Fitzgibbon, Jude; Gribben, John G; Davies, Jeffrey K

    2016-07-07

    Donor T-cell immune responses can eradicate lymphomas after allogeneic hematopoietic stem cell transplantation (AHSCT), but can also damage healthy tissues resulting in harmful graft-versus-host disease (GVHD). Next-generation sequencing has recently identified many new genetic lesions in follicular lymphoma (FL). One such gene, tumor necrosis factor receptor superfamily 14 (TNFRSF14), abnormal in 40% of FL patients, encodes the herpes virus entry mediator (HVEM) which limits T-cell activation via ligation of the B- and T-lymphocyte attenuator. As lymphoma B cells can act as antigen-presenting cells, we hypothesized that TNFRSF14 aberrations that reduce HVEM expression could alter the capacity of FL B cells to stimulate allogeneic T-cell responses and impact the outcome of AHSCT. In an in vitro model of alloreactivity, human lymphoma B cells with TNFRSF14 aberrations had reduced HVEM expression and greater alloantigen-presenting capacity than wild-type lymphoma B cells. The increased immune-stimulatory capacity of lymphoma B cells with TNFRSF14 aberrations had clinical relevance, associating with higher incidence of acute GVHD in patients undergoing AHSCT. FL patients with TNFRSF14 aberrations may benefit from more aggressive immunosuppression to reduce harmful GVHD after transplantation. Importantly, this study is the first to demonstrate the impact of an acquired genetic lesion on the capacity of tumor cells to stimulate allogeneic T-cell immune responses which may have wider consequences for adoptive immunotherapy strategies. © 2016 by The American Society of Hematology.

  16. Development and implementation of intranasal naloxone opioid overdose response protocol at a homeless health clinic.

    Science.gov (United States)

    Dahlem, Chin Hwa Y; Horstman, Molly J; Williams, Brent C

    2016-01-01

    To describe the development, implementation, and preliminary evaluation of Opioid Overdose Response Protocol using intranasal (IN) naloxone in a homeless shelter. Opioid Overdose Response Protocol and training curriculum were developed using the Massachusetts Department of Public Health Opioid Overdose Education and Naloxone Distribution (OEND) flow chart, the American Heart Association (AHA) simplified adult basic life support algorithm, and resources through Harms Reduction Coalition. Intranasal naloxone offers a safe and effective method for opioid reversal. To combat the rising incidence of opioid overdose, IN naloxone should be made available at homeless shelters and other facilities with high frequency of opioid overdose, including the training of appropriate staff. This project has demonstrated the effective training and implementation of an Opioid Overdose Response Protocol, based on feedback received from cardiopulmonary resuscitation (CPR) trained nonhealthcare staff. Nurse practitioners (NPs), with our focus on patient care, prevention, and education, are well suited to the deployment of this life-saving protocol. NPs are in critical positions to integrate opioid overdose prevention education and provide naloxone rescue kits in clinical practices. ©2015 American Association of Nurse Practitioners.

  17. Orienting-defense responses and psychophysiological reactivity in isolated clinic versus sustained hypertension.

    Science.gov (United States)

    García-Vera, María Paz; Sanz, Jesús; Labrador, Francisco J

    2007-04-01

    This study sought to determine whether patients with white-coat or isolated clinic hypertension (ICH) show, in comparison to patients with sustained hypertension (SH), a defense response pattern to novel stimuli and an enhanced psychophysiological reactivity to stress. Forty-three patients with essential hypertension were divided into two groups after 16 days of self-monitoring blood pressure (BP): ICH (24 men; self-measured BP men; self-measured BP >or= 135/85 mmHg). Defense responses were measured as the cardiac changes to phasic non-aversive auditory stimuli. Psychophysiological reactivity (heart and breath rate, blood volume pulse, electromyography, and skin conductance) was measured during mental arithmetic and video game tasks. The standard deviation of self-measured BPs and the difference between mean BPs at work and at home were used as indicators of cardiovascular reactivity to daily stress. No significant differences were seen in defense responses or psychophysiological reactivity to laboratory or naturally occurring stressors. These results do not support the hypothesis that ICH can be explained in terms of a generalized hyperreactivity to novel or stressful stimuli.

  18. Clinical course and treatment response in patients with thyroid hot nodule

    International Nuclear Information System (INIS)

    Fard Esfahani, A; Aghayousefi, H.R.; Eftekhari, M.; Fallahi, B.; Saghari, M.

    2002-01-01

    This is a retrospective study on clinical course and treatment response of patients with thyroid hot nodule, referred to nuclear medicine department of shariaty hospital from 1360 to 1377. From the total 58 patients with average age of 43 year and incidence peak of 40 year, 81 % were female and 19 % were male. 64 % of the patients were thyrotoxic and 36 % were euthyroid at presentation. Thyrotoxic symptoms and signs increased with age (p= 0.04). 57% of patients received I-131 therapy without premedication. 7% received antithyroid drugs first and then underwent iodine therapy. From 36% of the patients who were euthyroid at presentation, 15.5 % became thyrotoxic on follow up studies and received I-131 therapy, but 20.7 % remained euthyroid without receiving andy therapy. The average of first and cumulative radioiodine doses were 16.9 mci and 21.8 mci, respectively. Treatment response during 6 and 12 month follow up were 80 % and 86.7 %, respectively. The more administered the first dose, the better was the response (p= 0.03). Men appeared to need more I-131 dosage and times of therapy as compared to women. Post radioiodine hypothyroidism incidence was 7.5 % during one year follow up. No meaningful relation was found between times of radioiodine therapy and thyroid or nodule size

  19. Clinical and molecular response to interferon-α therapy in essential thrombocythemia patients with CALR mutations.

    Science.gov (United States)

    Verger, Emmanuelle; Cassinat, Bruno; Chauveau, Aurélie; Dosquet, Christine; Giraudier, Stephane; Schlageter, Marie-Hélène; Ianotto, Jean-Christophe; Yassin, Mohammed A; Al-Dewik, Nader; Carillo, Serge; Legouffe, Eric; Ugo, Valerie; Chomienne, Christine; Kiladjian, Jean-Jacques

    2015-12-10

    Myeloproliferative neoplasms are clonal disorders characterized by the presence of several gene mutations associated with particular hematologic parameters, clinical evolution, and prognosis. Few therapeutic options are available, among which interferon α (IFNα) presents interesting properties like the ability to induce hematologic responses (HRs) and molecular responses (MRs) in patients with JAK2 mutation. We report on the response to IFNα therapy in a cohort of 31 essential thrombocythemia (ET) patients with CALR mutations (mean follow-up of 11.8 years). HR was achieved in all patients. Median CALR mutant allelic burden (%CALR) significantly decreased from 41% at baseline to 26% after treatment, and 2 patients even achieved complete MR. In contrast, %CALR was not significantly modified in ET patients treated with hydroxyurea or aspirin only. Next-generation sequencing identified additional mutations in 6 patients (affecting TET2, ASXL1, IDH2, and TP53 genes). The presence of additional mutations was associated with poorer MR on CALR mutant clones, with only minor or no MRs in this subset of patients. Analysis of the evolution of the different variant allele frequencies showed that the mutated clones had a differential sensitivity to IFNα in a given patient, but no new mutation emerged during treatment. In all, this study shows that IFNα induces high rates of HRs and MRs in CALR-mutated ET, and that the presence of additional nondriver mutations may influence the MR to therapy. © 2015 by The American Society of Hematology.

  20. Comparative transcriptional analysis of clinically relevant heat stress response in Clostridium difficile strain 630.

    Directory of Open Access Journals (Sweden)

    Nigel G Ternan

    Full Text Available Clostridium difficile is considered to be one of the most important causes of health care-associated infections worldwide. In order to understand more fully the adaptive response of the organism to stressful conditions, we examined transcriptional changes resulting from a clinically relevant heat stress (41 °C versus 37 °C in C. difficile strain 630 and identified 341 differentially expressed genes encompassing multiple cellular functional categories. While the transcriptome was relatively resilient to the applied heat stress, we noted upregulation of classical heat shock genes including the groEL and dnaK operons in addition to other stress-responsive genes. Interestingly, the flagellin gene (fliC was downregulated, yet genes encoding the cell-wall associated flagellar components were upregulated suggesting that while motility may be reduced, adherence--to mucus or epithelial cells--could be enhanced during infection. We also observed that a number of phage associated genes were downregulated, as were genes associated with the conjugative transposon Tn5397 including a group II intron, thus highlighting a potential decrease in retromobility during heat stress. These data suggest that maintenance of lysogeny and genome wide stabilisation of mobile elements could be a global response to heat stress in this pathogen.

  1. Clinical characteristics and therapeutic response in patients with Burning Mouth Syndrome: accompanying 2 years

    Directory of Open Access Journals (Sweden)

    Vanessa Juliana Gomes CARVALHO

    Full Text Available Abstract Introduction Burning Mouth Syndrome (BMS is a condition characterized by burning symptom of the oral mucosa in the absence of clinical signs. Its etiology is still unknown and, and to date there is no effective treatment. Purpose The aim of this study was to evaluate patients with BMS profile and the therapies results in a retrospective study. Material and method Clinical and therapeutic data were collected from records of patients with BMS diagnosed between January 2013 to April 2015 at the Clinic of Stomatology Clinic, Faculdade de Odontologia of Universidade de São Paulo, according to the criteria established by the International Headache Society in 2013. The therapies used for BMS control were also evaluated. Result Twelve patients were diagnosed with BMS at this period. All of them were women with a mean age of 61.18 years and the apex of the tongue was the most common affected site and the duration of the burning sensation ranged from 6 months to 25 years. Many therapies were prescribed for BMS control, such as topical capsaicin, topical clonazepan, low level laser therapy and homeopathy. Among the established therapies, capsaicin has immediate effect in reducing symptoms. Conclusion The present study showed that the challenges towards an effective treatment for BMS are varied and are mainly related to the lack knowing of the pathogenesis of this disease. The demographic profile of patients studied here was similar to that described in the available literature, however, the variables represented by secondary symptoms (medical history, anxiety and depression levels may be modifying factors of therapeutic response and the pathogenesis of the disease itself.

  2. CCR 20th Anniversary Commentary: Immune-Related Response Criteria--Capturing Clinical Activity in Immuno-Oncology.

    Science.gov (United States)

    Hoos, Axel; Wolchok, Jedd D; Humphrey, Rachel W; Hodi, F Stephen

    2015-11-15

    To evaluate antitumor responses to chemotherapeutic agents, investigators would typically rely upon Response Evaluation Criteria in Solid Tumors (RECIST) or modified WHO criteria, which do not comprehensively capture responses with immunotherapeutic agents. In the December 1, 2009, issue of Clinical Cancer Research, Wolchok and colleagues reported their development of novel criteria, designated "Immune-related Response Criteria" (irRC), designed to better capture the response patterns observed with immunotherapies. Broad use of the irRC since then has allowed for a more comprehensive evaluation of immunotherapies in clinical trials, indicating that their concepts can be used in conjunction with either RECIST or WHO, and has shown irRC to be a powerful tool for improved clinical investigation. See related article by Wolchok et al., Clin Cancer Res 2009;15(23) December 1, 2009;7412-20. ©2015 American Association for Cancer Research.

  3. "Everyone just ate good food": 'Good food' in Islamabad, Pakistan.

    Science.gov (United States)

    Hasnain, Saher

    2018-08-01

    In recent years, consumption of alternatively produced foods has increased in popularity in response to the deleterious effects of rapidly globalising and industrialised food systems. Concerns over food safety in relation to these changes may result from elevated levels of risk and changing perceptions associated with food production practices. This paper explores how the middle class residents of Islamabad, Pakistan, use the concept of 'good food' to reconnect themselves with nature, changing food systems, and traditional values. The paper also demonstrates how these ideas relate to those of organic, local, and traditional food consumption as currently used in more economically developed states in the Global North. Through research based on participant observation and semi-structured interviews, this paper illustrates that besides price and convenience, purity, freshness, association with specific places, and 'Pakistani-ness' were considered as the basis for making decisions about 'good food'. The results show that while individuals are aware of and have some access to imported organic and local food, they prefer using holistic and culturally informed concepts of 'good food' instead that reconnect them with food systems. I argue that through conceptualisations of 'good food', the urban middle class in Islamabad is reducing their disconnection and dis-embeddedness from nature, the food systems, and their social identities. The paper contributes to literature on food anxieties, reconnections in food geography, and 'good food' perceptions, with a focus on Pakistan. Copyright © 2018. Published by Elsevier Ltd.

  4. Paradoxes around good governance

    NARCIS (Netherlands)

    A.G. Dijkstra (Geske)

    2013-01-01

    textabstract Good governance is not a new concept Ambrogio Lorenzetti made his frescoes on good and bad governance already in the years 1338-1340 They can be viewed in the Palazzo Publicco on one of the most beautiful squares of the world, the Piazza del Campo in Siena, Italy I assume many of you

  5. "Act in Good Faith."

    Science.gov (United States)

    McKay, Robert B.

    1979-01-01

    It is argued that the Supreme Court's Bakke decision overturning the University of California's minority admissions program is good for those who favor affirmative action programs in higher education. The Supreme Court gives wide latitude for devising programs that take race and ethnic background into account if colleges are acting in good faith.…

  6. Nurturing Good Ideas

    NARCIS (Netherlands)

    J.C.M. van den Ende (Jan); R.C. Kijkuit (Bob)

    2009-01-01

    textabstractManagers know that simply generating lots of ideas doesn’t necessarily produce good ones. What companies need are systems that nurture good ideas and cull bad ones—before they ever reach the decision maker’s desk. Our research shows that tapping the input of many people early in the

  7. An overview of GOOD

    NARCIS (Netherlands)

    Paredaens, J.; Van den Bussche, J.; Andries, M.; Gemis, M.; Gyssens, M.; Thyssens, I.; Van Gucht, D.; Sarathy, V.; Saxton, L.V.

    1992-01-01

    GOOD is an acronym, standing for Graph-Oriented Object Database. GOOD is being developed as a joint research effort of Indiana University and the University of Antwerp. The main thrust behind the project is to indicate general concepts that are fundamental to any graph-oriented database

  8. The Good Work.

    Science.gov (United States)

    Csikszentmihalyi, Mihaly

    2003-01-01

    Examines the working lives of geneticists and journalists to place into perspective what lies behind personal ethics and success. Defines "good work" as productive activity that is valued socially and loved by people engaged in it. Asserts that certain cultural values, social controls, and personal standards are necessary to maintain good work and…

  9. Advice on Good Grooming.

    Science.gov (United States)

    Tingey, Carol

    1987-01-01

    Suggestions are presented from parents on how to help children with disabilities (with particular focus on Downs Syndrome) learn good grooming habits in such areas as good health, exercise, cleanliness, teeth and hair care, skin care, glasses and other devices, and social behavior. (CB)

  10. Trust, moral responsibility, the self, and well-ordered societies: the importance of basic philosophical concepts for clinical ethics.

    Science.gov (United States)

    Mccullough, Laurence B

    2002-02-01

    Although the work of clinical ethics is intensely practical, it employs and presumes philosophical concepts from the central branches of philosophy, including metaphysics, epistemology, ethics, and political philosophy. This essay introduces this issue in the Journal on clinical ethics by considering how the papers and book reviews included in it illuminate four such concepts: trust, moral responsibility, the self and well-ordered societies.

  11. Irradiation of goods

    International Nuclear Information System (INIS)

    Lunt, R.E.

    1987-01-01

    Mechanical handling apparatus is adapted to handle goods, such as boxed fruit, during a process of irradiation, in palletized form. Palletized goods are loaded onto wheeled vehicles in a loading zone. Four vehicles are wheeled on a track into an irradiation zone via a door in a concrete shield. The vehicles are arranged in orthogonal relationship around a source of square section. Turntables are positioned at corners of the square shaped rail truck around the source selectively to turn the vehicles to align then with track sections. Mechanical manipulating devices are positioned in the track sections opposed to sides of the source. During irradiation, the vehicles and their palletized goods are cylically moved toward the source to offer first sides of the goods for irradiation and are retraced from the source and are pivoted through 90 0 to persent succeeding sides of the goods for irradiation

  12. Long-term follow up of patients with good outcome after intra-arterial thrombolysis for major arterial occlusion in the carotid territory. Clinical and magnetic resonance imaging evaluation

    International Nuclear Information System (INIS)

    Sorimachi, Takatoshi; Morita, Kenichi; Ito, Yasushi; Fujii, Yukihiko

    2010-01-01

    Long-term clinical symptoms, including extrapyramidal signs, and magnetic resonance (MR) imaging studies were retrospectively analyzed in 21 patients with good outcome (modified Rankin scale scores 0-2) after successful recanalization of occluded major arteries by intra-arterial thrombolysis with mechanical disruption. Changes in high intensity areas (HIAs) and cerebral atrophy in the ischemic hemisphere were evaluated on follow-up fluid-attenuated inversion recovery MR images. Extrapyramidal signs, short-stepped gait and/or masked face, were observed in 12 of 21 patients during the follow-up period (11 to 68 months, mean 42 months). Enlargement of HIA was demonstrated in 10 of 18 patients undergoing follow-up MR imaging. Cerebral atrophy in the ischemic hemisphere was revealed on the follow-up MR images in all 18 patients. In nine patients with small infarctions, 20 ml or less on computed tomography scans, cerebral atrophy progressed more rapidly in four patients with extrapyramidal signs compared to the other five patients without extrapyramidal signs (p<0.05). More than half of the patients with good outcome showed extrapyramidal signs. Extrapyramidal signs in patients with small infarction may indicate rapid progression of cerebral atrophy. The occurrence of extrapyramidal signs might be related to delayed neuronal death in atrophic areas. (author)

  13. Clinical test responses to different orthoptic exercise regimes in typical young adults.

    Science.gov (United States)

    Horwood, Anna; Toor, Sonia

    2014-03-01

    The relative efficiency of different eye exercise regimes is unclear, and in particular the influences of practice, placebo and the amount of effort required are rarely considered. This study measured conventional clinical measures following different regimes in typical young adults. A total of 156 asymptomatic young adults were directed to carry out eye exercises three times daily for 2 weeks. Exercises were directed at improving blur responses (accommodation), disparity responses (convergence), both in a naturalistic relationship, convergence in excess of accommodation, accommodation in excess of convergence, and a placebo regime. They were compared to two control groups, neither of which were given exercises, but the second of which were asked to make maximum effort during the second testing. Instruction set and participant effort were more effective than many exercises. Convergence exercises independent of accommodation were the most effective treatment, followed by accommodation exercises, and both regimes resulted in changes in both vergence and accommodation test responses. Exercises targeting convergence and accommodation working together were less effective than those where they were separated. Accommodation measures were prone to large instruction/effort effects and monocular accommodation facility was subject to large practice effects. Separating convergence and accommodation exercises seemed more effective than exercising both systems concurrently and suggests that stimulation of accommodation and convergence may act in an additive fashion to aid responses. Instruction/effort effects are large and should be carefully controlled if claims for the efficacy of any exercise regime are to be made. © 2014 The Authors Ophthalmic & Physiological Optics published by John Wiley & Sons Ltd on behalf of The College of Optometrists.

  14. Achieving simplified disease activity index remission in patients with active rheumatoid arthritis is associated with subsequent good functional and structural outcomes in a real-world clinical setting under a treat-to-target strategy.

    Science.gov (United States)

    Hirano, Fumio; Yokoyama, Waka; Yamazaki, Hayato; Amano, Koichi; Kawakami, Atsushi; Hayashi, Taichi; Tamura, Naoto; Yasuda, Shinsuke; Dobashi, Hiroaki; Fujii, Takao; Ito, Satoshi; Kaneko, Yuko; Matsui, Toshihiro; Okuda, Yasuaki; Saito, Kazuyoshi; Suzuki, Fumihito; Yoshimi, Ryusuke; Sakai, Ryoko; Koike, Ryuji; Kohsaka, Hitoshi; Miyasaka, Nobuyuki; Harigai, Masayoshi

    2017-09-01

    To verify predictive validity of simplified disease activity index (SDAI) remission for subsequent functional and structural outcomes in real-world clinical settings under a treat-to-target strategy (T2T). In this multicenter, prospective cohort study, T2T was implemented in rheumatoid arthritis (RA) patients with moderate-to-high disease activity. SDAI or clinical disease activity index (CDAI) was assessed every 12 weeks, and treatment was adjusted to achieve clinical remission or low disease activity (LDA). Multivariate logistic regression models were used to examine the associations of SDAI remission (≤3.3) at week 24 with the health assessment questionnaire-disability index (HAQ-DI) ≤ 0.5 or with the delta van der Heijde-modified total Sharp score (ΔvdH-mTSS) good outcomes was verified in a T2T-implementing cohort in the current clinical settings.

  15. Good breastfeeding policies -- good breastfeeding rates.

    Science.gov (United States)

    1998-01-01

    In Norway, where breast-feeding policies protecting breast-feeding women's needs have been in place since the 1970s, approximately 97% of women breast feed when leaving the hospital, 80% are breast feeding at 3 months, and 20% beyond 12 months. Government family policies play an important role in enabling women to achieve good breast-feeding rates. In Norway: maternity leave is 42 weeks with full pay or 52 weeks with 80% of salary; flexible part-time is available for women from 2 months after giving birth with income supplemented from maternity benefits; after returning to work, women are entitled to 1- to 1.5-hour breaks to return home to breast feed, or to have the child brought to work. "Breast feeding is so normal," writes Hege Jacobson Lepri, "it's more embarrassing to bring out the feeding bottle in public." full text

  16. 'She sort of shines': midwives' accounts of 'good' midwifery and 'good' leadership.

    Science.gov (United States)

    Byrom, Sheena; Downe, Soo

    2010-02-01

    to explore midwives' accounts of the characteristics of 'good' leadership and 'good' midwifery. a phenomenological interview survey. Participants were asked about what made both good and poor midwives and leaders. two maternity departments within National Health Service trusts in the North West of England. qualified midwives, selected by random sampling stratified to encompass senior and junior grades. thematic analysis, carried out manually. ten midwives were interviewed. Sixteen codes and six sub-themes were generated. Across the responses, two clear dimensions (themes) were identified, relating on the one hand to aspects of knowledge, skill and competence (termed 'skilled competence'), and on the other hand to specific personality characteristics (termed 'emotional intelligence'). This study suggests that the ability to act knowledgeably, safely and competently was seen as a basic requirement for both clinical midwives and midwife leaders. The added element which made both the midwife and the leader 'good' was the extent of their emotional capability. this small-scale in-depth study could form the basis for hypothesis generation for larger scale work in this area in future. The findings offer some reinforcement for the potential applicability of theories of transformational leadership to midwifery management and practice. Copyright 2008 Elsevier Ltd. All rights reserved.

  17. Autoantibody levels in myositis patients correlate with clinical response during B cell depletion with rituximab.

    Science.gov (United States)

    Aggarwal, Rohit; Oddis, Chester V; Goudeau, Danielle; Koontz, Diane; Qi, Zengbiao; Reed, Ann M; Ascherman, Dana P; Levesque, Marc C

    2016-06-01

    To determine the longitudinal trends in serum levels of four myositis-associated autoantibodies: anti-Jo-1, -transcription intermediary factor 1 γ (TIF1-γ), -signal recognition particle (SRP) and -Mi-2, after B cell depletion with rituximab, and to determine the longitudinal association of these autoantibody levels with disease activity as measured by myositis core-set measures (CSMs). Treatment-resistant adult and pediatric myositis subjects (n = 200) received rituximab in the 44-week Rituximab in Myositis Trial. CSMs [muscle enzymes, manual muscle testing (MMT), physician and patient global disease activity, HAQ, and extramuscular disease activity] were evaluated monthly and anti-Jo-1 (n = 28), -TIF1-γ (n = 23), -SRP (n = 25) and -Mi-2 (n = 26) serum levels were measured using validated quantitative ELISAs. Temporal trends and the longitudinal relationship between myositis-associated autoantibodies levels and CSM were estimated using linear mixed models. Following rituximab, anti-Jo-1 levels decreased over time (P myositis subjects decreased after B cell depletion and were correlated with changes in disease activity, whereas anti-SRP levels were only associated with longitudinal muscle enzyme levels. The strong association of anti-Jo-1 levels with clinical outcomes suggests that anti-Jo-1 autoantibodies may be a good biomarker for disease activity. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  18. Clinical Responses to Atomoxetine in Attention-Deficit/Hyperactivity Disorder: The Integrated Data Exploratory Analysis (IDEA) Study

    Science.gov (United States)

    Newcorn, Jeffrey H.; Sutton, Virginia K.; Weiss, Margaret D.; Sumner, Calvin R.

    2009-01-01

    Data from six randomized controlled trials in the U.S. reveal that 47 percent of patients aged six to 18 years showed a much improved clinical response to atomoxetine as a treatment for attention deficit hyperactivity disorder while 40 percent did not have a response. Augmenting or switching treatment in non-responders by week 4 is suggested.

  19. Clinical characteristics and treatment response to SSRI in a female pedophile.

    Science.gov (United States)

    Chow, Eva W C; Choy, Alberto L

    2002-04-01

    Although much investigation has been done with male sex offenders, there have been few studies on female sex offenders. Female sex offenders have been reported as having a high incidence of psychiatric disorders, but female paraphilics were rarely described. The literature on the treatment of female sex offenders is also limited and treatment with a selective serotonin reuptake inhibitor (SSRI) has not been reported. This paper presents the case of a woman with DSM-IV pedophilia. Her clinical characteristics, her offense history, and her positive response to treatment with sertraline (a SSRI) are described. This case adds to the limited literature on female pedophiles and suggests that SSRIs may be an effective treatment for paraphilic disorders in female sex offenders.

  20. Prevention of infectious diseases in patients with Good syndrome.

    Science.gov (United States)

    Multani, Ashrit; Gomez, Carlos A; Montoya, José G

    2018-08-01

    Good syndrome is a profoundly immunocompromising condition with heterogeneous immune deficits characterized by the presence of thymoma, low-to-absent B-lymphocyte counts, hypogammaglobulinemia, and impaired cell-mediated immunity. Opportunistic infectious diseases associated with Good syndrome represent a diagnostic and therapeutic challenge, given their protean clinical manifestations. Although these infectious complications have been reviewed in prior publications, recommendations regarding their prevention have been lacking. Good syndrome usually occurs in adult patients between the ages of 40 and 70 years. Immunologically, it is characterized by low or absent peripheral blood B lymphocytes, hypogammaglobulinemia, and variable defects in cell-mediated immunity including low CD4 T counts, inverted CD4:CD8 T-lymphocyte ratio, and reduced T-lymphocyte mitogen proliferative responses. Patients with Good syndrome are susceptible to a variety of infectious diseases, of which the most common are recurrent bacterial sinopulmonary infections, mucocutaneous candidiasis, and CMV tissue-invasive disease. Preventive guidelines including targeted antimicrobial prophylaxis and vaccination strategies can mitigate infectious complications in patients with Good syndrome. Immunological deficits and infectious complications in Good syndrome have been described for over 60 years. Further research is needed to elucidate its exact pathogenesis and define the mechanistic relationship between thymoma and hypogammaglobulinemia. However, tailored prophylactic strategies can be recommended for patients with Good syndrome.

  1. Peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic heller myotomy.

    Science.gov (United States)

    Khashab, Mouen A; Kumbhari, Vivek; Tieu, Alan H; El Zein, Mohamad H; Ismail, Amr; Ngamruengphong, Saowanee; Singh, Vikesh K; Kalloo, Anthony N; Clarke, John O; Stein, Ellen M

    2017-01-01

    Several uncontrolled studies comparing peroral endoscopic myotomy (POEM) and Heller myotomy have demonstrated equivalent short-term efficacy and safety. However, no data exists rergarding the cost of POEM and how it compares to that of robotic Heller myotomy (RHM). The primary aim of this study was to compare the inpatient charges incurred in patients who underwent POEM or RHM for the treatment of achalasia. A retrospective single center review was conducted among 52 consecutive POEM patients (2012-2014) and 52 consecutive RHM patients (2009-2014). All RHM procedures included a Toupet fundoplication and were performed via a transabdominal approach. All POEM procedures were performed by a gastroenterologist in the endoscopy unit. Clinical response was defined by improvement of symptoms and decrease in Eckardt stage to ≤I. All procedural and facility charges were obtained from review of the hospital finance records. There was no difference between POEM and RHM with regards to age, gender, symptom duration, achalasia subtype, manometry findings, or Eckardt symptom stage. There was no significant difference in the rate of adverse events (19.2% vs 9.6%, P = 0.26) or the length of stay (1.9 vs. 2.3, P = 0.18) between both groups. Clinical response rate of patients in the POEM groups was similar to that in the RHM group (94.3% vs. 88.5%, P = 0.48). POEM incurred significantly less total charges compared to LHM ($14481 vs. $17782, P = 0.02). POEM when performed in an endoscopy unit was similar in efficacy and safety to RHM. However, POEM was associated with significant cost savings ($3301/procedure).

  2. Empirically derived personality subtyping for predicting clinical symptoms and treatment response in bulimia nervosa.

    Science.gov (United States)

    Haynos, Ann F; Pearson, Carolyn M; Utzinger, Linsey M; Wonderlich, Stephen A; Crosby, Ross D; Mitchell, James E; Crow, Scott J; Peterson, Carol B

    2017-05-01

    Evidence suggests that eating disorder subtypes reflecting under-controlled, over-controlled, and low psychopathology personality traits constitute reliable phenotypes that differentiate treatment response. This study is the first to use statistical analyses to identify these subtypes within treatment-seeking individuals with bulimia nervosa (BN) and to use these statistically derived clusters to predict clinical outcomes. Using variables from the Dimensional Assessment of Personality Pathology-Basic Questionnaire, K-means cluster analyses identified under-controlled, over-controlled, and low psychopathology subtypes within BN patients (n = 80) enrolled in a treatment trial. Generalized linear models examined the impact of personality subtypes on Eating Disorder Examination global score, binge eating frequency, and purging frequency cross-sectionally at baseline and longitudinally at end of treatment (EOT) and follow-up. In the longitudinal models, secondary analyses were conducted to examine personality subtype as a potential moderator of response to Cognitive Behavioral Therapy-Enhanced (CBT-E) or Integrative Cognitive-Affective Therapy for BN (ICAT-BN). There were no baseline clinical differences between groups. In the longitudinal models, personality subtype predicted binge eating (p = 0.03) and purging (p = 0.01) frequency at EOT and binge eating frequency at follow-up (p = 0.045). The over-controlled group demonstrated the best outcomes on these variables. In secondary analyses, there was a treatment by subtype interaction for purging at follow-up (p = 0.04), which indicated a superiority of CBT-E over ICAT-BN for reducing purging among the over-controlled group. Empirically derived personality subtyping appears to be a valid classification system with potential to guide eating disorder treatment decisions. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2017; 50:506-514). © 2016 Wiley Periodicals, Inc.

  3. Clinical diagnosis of polycystic ovarian syndrome and response to metformin therapy

    International Nuclear Information System (INIS)

    Tariq, N.; Ayub, R.; Alam, A.Y.; Raees, S.R.

    2007-01-01

    To determine the accuracy of diagnosing polycystic ovarian syndrome (PCOS) predominantly on clinical features and the response to metformin therapy. Women fulfilling the inclusion criteria (oligo/hypomenorrhea, infertility, weight gain, hyperandrogenism) were enrolled. Ultrasound pelvis was obtained in all women. Presence of eight or more multiple follicles in both or one ovary without presence of mature follicle was the cutoff number for positive ultrasound. Thyroid stimulating hormone levels were performed in all patients, and patients with abnormal levels were excluded from the study. Metformin was adjusted to 500 mg thrice daily. Six months later patients were again evaluated for response to metformin therapy and those who failed to conceive were given clomiphene citrate along with metformin. Fertility was re-evaluated at the end of one year. At the start of the study, 81% women had menstrual irregularity and 84% had infertility. Hirsutism was seen in 72% while history of weight gain was present in 62% of patients. Ultrasound evidence of polycystic ovaries was seen in 93% of women. After 6 months of metformin therapy, 80% patients had achieved correction in their menstrual irregularity. After 6 months on metformin alone, 51% patients conceived while an additional 20% conceived on both metformin and clomiphene citrate during next 6 months. Overall fertility rate was 71% at the end of one year. There was statistically significant change in pre-treatment and post-treatment BMI. Combination of three or more of the clinical features (irregular cycles, history of weight gain, infertility and hirsutism) provide an appropriate basis for the diagnosis of PCOS. Metformin alone was an effective treatment for PCOS in this series. (author)

  4. Clinical relevance of the ROC and free-response paradigms for comparing imaging system efficacies

    International Nuclear Information System (INIS)

    Chakraborty, D. P.

    2010-01-01

    Observer performance studies are widely used to assess medical imaging systems. Unlike technical/engineering measurements observer performance include the entire imaging chain and the radiologist. However, the widely used receiver operating characteristic (ROC) method ignores lesion localisation information. The free-response ROC (FROC) method uses the location information to appropriately reward or penalise correct or incorrect localizations, respectively. This paper describes a method for improving the clinical relevance of FROC studies. The method consists of assigning appropriate risk values to the different lesions that may be present on a single image. A high-risk lesion is one that is critical to detect and act upon, and is assigned a higher risk value than a low-risk lesion, one that is relatively innocuous. Instead of simply counting the number of lesions that are detected, as is done in conventional FROC analysis, a risk-weighted count is used. This has the advantage of rewarding detections of high-risk lesions commensurately more than detections of lower risk lesions. Simulations were used to demonstrate that the new method, termed case-based analysis, results in a higher figure of merit for an expert who detects more high-risk lesions than a naive observer who detects more low-risk lesions, even though both detect the same total number of lesions. Conventional free-response analysis is unable to distinguish between the two types of observers. This paper also comments on the issue of clinical relevance of ROC analysis vs. FROC for tasks that involve lesion localisation. (authors)

  5. Customs control of goods

    Directory of Open Access Journals (Sweden)

    Mentor Gashi

    2015-11-01

    Full Text Available Customs control, is regulated by law in different countries. Different countries define through the law, the control of goods.. Main purpose of this paper is to analyze two types of customs controls, and their effect in reducing avoidance of duty or tax evasion which may be caused by the import of goods of certain companies. For this reason we researched which model is implemented in developing countries and what results were reached through questionnaires. In this sense the next research question, consists in defining the moment of customs control pre or post-clearance control of goods.

  6. Transportation of hazardous goods

    CERN Multimedia

    TS Department

    2008-01-01

    A general reminder: any transportation of hazardous goods by road is subject to the European ADR rules. The goods concerned are essentially the following: Explosive substances and objects; Gases (including aerosols and non-flammable gases such as helium and nitrogen); Flammable substances and liquids (inks, paints, resins, petroleum products, alcohols, acetone, thinners); Toxic substances (acids, thinners); Radioactive substances; Corrosive substances (paints, acids, caustic products, disinfectants, electrical batteries). Any requests for the transport of hazardous goods must be executed in compliance with the instructions given at this URL: http://ts-dep.web.cern.ch/ts-dep/groups/he/HH/adr.pdf Heavy Handling Section TS-HE-HH 73793 - 160364

  7. TRANSPORT OF COUNTERFEIT GOODS

    Directory of Open Access Journals (Sweden)

    Dagmar Babčanová

    2014-09-01

    Full Text Available The paper is focused on a current problem of transport of counterfeit goods in the European Union. Counterfeiting has a strong influence on the distribution organizations worldwide because most of counterfeit goods threaten the health and safety of consumers. Counterfeiting is a serious problem in the world economy today. The purpose of this paper is to point out the danger of counterfeiting in connection with the transport of Intellectual Property (IP rights - infringing goods. Background of the paper’s content is based on secondary data research of publicly available sources - international statistics and world reports.

  8. Doing Good, Feeling Bad

    DEFF Research Database (Denmark)

    Sharma, Devika

    2017-01-01

    For decades humanitarianism has captured and shaped the dreams of the populations of the global North, dreams of a better world, of a common humanity, of goodness, of solidarity, and of global healing. In this article I argue that when taking art and cultural objects into account humanitarian......, Danmarks Indsamling [Denmark Collects], and the second is from Norwegian playwright Arne Lygre’s 2011 play, I Disappear. What is at stake in both of these scenes is the status of humanitarianism as a good-enough fantasy and promise of doing good....

  9. Clinical determinants of clopidogrel responsiveness in a heterogeneous cohort of Puerto Rican Hispanics.

    Science.gov (United States)

    Hernandez-Suarez, Dagmar F; Scott, Stuart A; Tomey, Matthew I; Melin, Kyle; Lopez-Candales, Angel; Buckley, Charlotte E; Duconge, Jorge

    2017-09-01

    Clopidogrel is by far the most prescribed platelet adenosine diphosphate (ADP) antagonist in Puerto Rico despite the advent of newer agents (prasugrel and ticagrelor). Given the paucity of data on clopidogrel responsiveness in Hispanics, we sought to determine the association between clinical characteristics and platelet reactivity in Puerto Rican patients on clopidogrel therapy. A total of 100 Puerto Rican patients on clopidogrel therapy were enrolled and allocated into two groups: Group I, without high on-treatment platelet reactivity (HTPR); and Group II, with HTPR. Platelet function was measured ex vivo using the VerifyNow® P2Y12 assay. The cohort was comprised of Hispanic patients with coronary artery disease (57%), peripheral artery disease (32%), carotid artery stenosis (7%), cerebral artery aneurysm (2%), and stroke (2%). Mean platelet reactivity was 200 ± 61 P2Y12 reaction units (PRUs) (range: 8-324), and 35% of patients had HTPR (PRUs ⩾ 230). Multivariable logistic regression analysis determined that diabetes mellitus (DM) [odds ratio (OR) = 3.27; 95% confidence interval (CI): 1.20-8.96], use of proton-pump inhibitors (PPIs) (OR = 3.60; 95% CI: 1.09-11.82), and calcium channel blockers (CCBs) (OR = 3.10; 95% CI: 1.09-8.83) were independent predictors of HTPR ( p Puerto Rican Hispanic patients on clopidogrel, 35% had HTPR. Furthermore, DM, PPIs and CCBs predicted HTPR. Clinical outcome data are needed to identify appropriate PRU thresholds for risk prediction in the Puerto Rican population.

  10. The Physiological Basis and Clinical Use of the Binaural Interaction Component of the Auditory Brainstem Response

    Science.gov (United States)

    Klump, Georg M.; Tollin, Daniel J.

    2016-01-01

    The auditory brainstem response (ABR) is a sound-evoked non-invasively measured electrical potential representing the sum of neuronal activity in the auditory brainstem and midbrain. ABR peak amplitudes and latencies are widely used in human and animal auditory research and for clinical screening. The binaural interaction component (BIC) of the ABR stands for the difference between the sum of the monaural ABRs and the ABR obtained with binaural stimulation. The BIC comprises a series of distinct waves, the largest of which (DN1) has been used for evaluating binaural hearing in both normal hearing and hearing-impaired listeners. Based on data from animal and human studies, we discuss the possible anatomical and physiological bases of the BIC (DN1 in particular). The effects of electrode placement and stimulus characteristics on the binaurally evoked ABR are evaluated. We review how inter-aural time and intensity differences affect the BIC and, analyzing these dependencies, draw conclusion about the mechanism underlying the generation of the BIC. Finally, the utility of the BIC for clinical diagnoses are summarized. PMID:27232077

  11. Veteran satisfaction and treatment preferences in response to a posttraumatic stress disorder specialty clinic orientation group.

    Science.gov (United States)

    Schumm, Jeremiah A; Walter, Kristen H; Bartone, Anne S; Chard, Kathleen M

    2015-06-01

    To maximize accessibility to evidence-based treatments for posttraumatic stress disorder (PTSD), the United States Department of Veterans Affairs (VA) has widely disseminated cognitive processing therapy (CPT) and prolonged exposure (PE) therapy to VA clinicians. However, there is a lack of research on veteran preferences when presented with a range of psychotherapy and medication options. This study uses a mixed-method approach to explore veteran satisfaction with a VA PTSD specialty clinic pre-treatment orientation group, which provides education about available PTSD treatment options. This study also tested differences in treatment preference in response to the group. Participants were 183 US veterans. Most were White, male, and referred to the clinic by a VA provider. Results indicated high satisfaction with the group in providing an overview of services and helping to inform treatment choice. Most preferred psychotherapy plus medications (63.4%) or psychotherapy only (30.1%). Participants endorsed a significantly stronger preference for CPT versus other psychotherapies. PE was significantly preferred over nightmare resolution therapy and present-centered therapy, and both PE and cognitive-behavioral conjoint therapy were preferred over virtual reality exposure therapy. Results suggest that by informing consumers about evidence-based treatments for PTSD, pre-treatment educational approaches may increase consumer demand for these treatment options. Published by Elsevier Ltd.

  12. RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

    Science.gov (United States)

    Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

    2015-08-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

  13. Mechanistic correlates of clinical responses to omalizumab in the setting of oral immunotherapy for milk allergy.

    Science.gov (United States)

    Frischmeyer-Guerrerio, Pamela A; Masilamani, Madhan; Gu, Wenjuan; Brittain, Erica; Wood, Robert; Kim, Jennifer; Nadeau, Kari; Jarvinen, Kirsi M; Grishin, Alexander; Lindblad, Robert; Sampson, Hugh A

    2017-10-01

    In our recent clinical trial, the addition of omalizumab to oral immunotherapy (OIT) for milk allergy improved safety, but no significant clinical benefit was detected. We sought to investigate mechanisms by which omalizumab modulates immunity in the context of OIT and to identify baseline biomarkers that predict subgroups of patients most likely to benefit from omalizumab. Blood was obtained at baseline and multiple time points during a placebo-controlled trial of OIT for milk allergy in which subjects were randomized to receive omalizumab or placebo. Immunologic outcomes included measurement of basophil CD63 expression and histamine release and casein-specific CD4 + regulatory T-cell proliferation. Biomarkers were analyzed in relationship to measurements of safety and efficacy. Milk-induced basophil CD63 expression was transiently reduced in whole blood samples from both omalizumab- and placebo-treated subjects. However, IgE-dependent histamine release increased in washed cell preparations from omalizumab- but not placebo-treated subjects. No increase in regulatory T-cell frequency was evident in either group. Subjects with lower rates of adverse reactions, regardless of arm, experienced better clinical outcomes. Pre-OIT basophil reactivity positively associated with occurrence of symptoms during OIT, whereas the baseline milk IgE/total IgE ratio correlated with the likelihood of achieving sustained unresponsiveness. A combination of baseline basophil and serologic biomarkers defined a subset of patients in which adjunctive therapy with omalizumab was associated with attainment of sustained unresponsiveness and a reduction in adverse reactions. Combining omalizumab therapy with milk OIT led to distinct alterations in basophil reactivity but not T-cell responses. Baseline biomarkers can identify subjects most likely to benefit from adjunctive therapy with omalizumab. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. All rights reserved.

  14. Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a.

    Science.gov (United States)

    Rudick, R A; Pace, A; Rani, M R S; Hyde, R; Panzara, M; Appachi, S; Shrock, J; Maurer, S L; Calabresi, P A; Confavreux, C; Galetta, S L; Lublin, F D; Radue, E-W; Ransohoff, R M

    2009-06-09

    Findings from a small clinical study suggested that statins may counteract the therapeutic effects of interferon beta (IFNbeta) in patients with relapsing-remitting multiple sclerosis (RRMS). We conducted a post hoc analysis of data from the Safety and Efficacy of Natalizumab in Combination With IFNbeta-1a in Patients With Relapsing-Remitting Multiple Sclerosis (SENTINEL) study to determine the effects of statins on efficacy of IFNbeta. SENTINEL was a prospective trial of patients with RRMS treated with natalizumab (Tysabri, Biogen Idec, Inc., Cambridge, MA) plus IM IFNbeta-1a (Avonex, Biogen Idec, Inc.) 30 microg compared with placebo plus IM IFNbeta-1a 30 microg. Clinical and MRI outcomes in patients treated with IM IFNbeta-1a only (no-statins group, n = 542) were compared with those of patients taking IM IFNbeta-1a and statins at doses used to treat hyperlipidemia (statins group, n = 40). No significant differences were observed between treatment groups in adjusted annualized relapse rate (p = 0.937), disability progression (p = 0.438), number of gadolinium-enhancing lesions (p = 0.604), or number of new or enlarging T2-hyperintense lesions (p = 0.802) at 2 years. More patients in the statins group reported fatigue, extremity pain, muscle aches, and increases in hepatic transaminases compared with patients in the no-statins group. Statin treatment had no ex vivo or in vitro effect on induction of IFN-stimulated genes. Statin therapy does not appear to affect clinical effects of IM interferon beta-1a in patients with relapsing-remitting multiple sclerosis or the primary molecular response to interferon beta treatment.

  15. [Autoimmune hepatitis in children and adolescents: clinical study, diagnosis and therapeutic response].

    Science.gov (United States)

    Ferreira, Alexandre R; Roquete, Mariza L V; Penna, Francisco J; Toppa, Nivaldo H

    2002-01-01

    The aim of this study was to evaluate the clinical, laboratory and histopathological characteristics and the response to immunosuppression in children and adolescents with autoimmune hepatitis (AIH). The present research is a descriptive study consisting of 39 children and adolescents with AIH who receive care at the Department of Pediatric Gastroenterology of Hospital das Clínicas (UFMG) from 1986 to 1998. Children's age ranged from 1.6 to 17 years (mean 8.7 +/- 3.49), most of them were females (87.2%). There were three types of clinical presentations: chronic (53.9%), acute (41%), and serious hepatic failure (5.1%). The most relevant laboratory parameters were the aminotransferases and gamma-globulin increase. Antinuclear antibodies were positive in 66.7% of the patients, while smooth muscle antibodies were positive in 52.8% and anti-LKM1 in 3% of the patients. In the histopathology the most important findings were the piecemeal necrosis (93.7%), moderate to severe portal inflammation (78.1%), definitive or incomplete cirrhosis (76.9%), absence of lesion of biliary ducts (93.7%) and presence of rosettes (90.6%). During the treatment, 77.8% obtained complete resolution, associated to side effects in 27.8% of them. Seven patients died (17.9%). During the treatment there was significant z score reduction (p<0.05) for height/age. After carrying out this study, we observed that the typical characteristics of AIH were: female sex, several clinical presentations, increased aminotransferase, and hypergammaglobulinemia. Histopathology showed a predominance of incipient and/or definitive cirrhosis associated with moderate to severe portal inflammation and piecemeal necrosis. Treatment using corticosteroids and azathioprine, turned out to be effective. However, the reduction in the height/age z score probably represents an adverse effect of corticoid treatment.

  16. Randomized clinical trial of Appendicitis Inflammatory Response score-based management of patients with suspected appendicitis.

    Science.gov (United States)

    Andersson, M; Kolodziej, B; Andersson, R E

    2017-10-01

    The role of imaging in the diagnosis of appendicitis is controversial. This prospective interventional study and nested randomized trial analysed the impact of implementing a risk stratification algorithm based on the Appendicitis Inflammatory Response (AIR) score, and compared routine imaging with selective imaging after clinical reassessment. Patients presenting with suspicion of appendicitis between September 2009 and January 2012 from age 10 years were included at 21 emergency surgical centres and from age 5 years at three university paediatric centres. Registration of clinical characteristics, treatments and outcomes started during the baseline period. The AIR score-based algorithm was implemented during the intervention period. Intermediate-risk patients were randomized to routine imaging or selective imaging after clinical reassessment. The baseline period included 1152 patients, and the intervention period 2639, of whom 1068 intermediate-risk patients were randomized. In low-risk patients, use of the AIR score-based algorithm resulted in less imaging (19·2 versus 34·5 per cent; P appendicitis (6·8 versus 9·7 per cent; P = 0·034). Intermediate-risk patients randomized to the imaging and observation groups had the same proportion of negative appendicectomies (6·4 versus 6·7 per cent respectively; P = 0·884), number of admissions, number of perforations and length of hospital stay, but routine imaging was associated with an increased proportion of patients treated for appendicitis (53·4 versus 46·3 per cent; P = 0·020). AIR score-based risk classification can safely reduce the use of diagnostic imaging and hospital admissions in patients with suspicion of appendicitis. Registration number: NCT00971438 ( http://www.clinicaltrials.gov). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  17. Acute herpes zoster neuralgia: retrospective analysis of clinical aspects and therapeutic responsiveness.

    Science.gov (United States)

    Haas, N; Holle, E; Hermes, B; Henz, B M

    2001-01-01

    Although the efficacy of modern antiviral agents for the treatment of herpes zoster is unquestioned, their ability to affect the associated pain remains controversial. We have therefore evaluated the inpatient hospital records of 550 patients with herpes zoster with regard to pain-related clinical aspects and therapeutic responsiveness. Intensity of pain was quantified by calculating a daily pain equivalence index (PEI) on the basis of different classes of pain medication and the number of tablets used in each category. The mean age of patients was 66.7 years, cranial segments were predominantly involved (55%), 64% of patients suffered from associated diseases and 77% experienced herpes-related pain. The PEI was 0.90 in the entire patient population, with significantly higher values in women and in patients with 3 or more associated diseases. It was lower in sacral and cranial nerve involvement, and it decreased rapidly in patients prior to discharge from hospital. Although there were significant differences in hospital stay between patients who received aciclovir and those who did not (mean 20.3 vs. 23.8 days), and for high- versus low-dose oral or intravenous administration, no significant differences were noted between the two groups for initial PEI values and during the course of observation, irrespective of the route of administration or the dose of aciclovir and the individual patient's PEI value. The groups were otherwise closely similar with regard to basic demographic and clinical data. 23.3% predominantly aged female patients with more associated diseases than the total patient population had a persistently elevated PEI and stayed in hospital beyond 21 days (mean 35.1 days), representing patients who went on to postherpetic neuralgia. These data further delineate clinical aspects of acute herpes zoster neuralgia, underline the unsolved therapeutic problems associated with this condition despite otherwise effective antiviral treatment, and characterise a

  18. Hoarding in Youth with Autism Spectrum Disorders and Anxiety: Incidence, Clinical Correlates, and Behavioral Treatment Response.

    Science.gov (United States)

    Storch, Eric A; Nadeau, Joshua M; Johnco, Carly; Timpano, Kiara; McBride, Nicole; Jane Mutch, P; Lewin, Adam B; Murphy, Tanya K

    2016-05-01

    This study examined the nature and correlates of hoarding among youth with autism spectrum disorders (ASD). Forty children with ASD and a comorbid anxiety disorder were administered a battery of clinician-administered measures assessing presence of psychiatric disorders and anxiety severity. Parents completed questionnaires related to child hoarding behaviors, social responsiveness, internalizing and externalizing behaviors, and functional impairment. We examined the impact of hoarding behaviors on treatment response in a subsample of twenty-six youth who completed a course of personalized cognitive-behavioral therapy targeting anxiety symptoms. Hoarding symptoms were common and occurred in a clinically significant manner in approximately 25 % of cases. Overall hoarding severity was associated with increased internalizing and anxiety/depressive symptoms, externalizing behavior, and attention problems. Discarding items was associated with internalizing and anxious/depressive symptoms, but acquisition was not. Hoarding decreased following cognitive-behavioral therapy but did not differ between treatment responders and non-responders. These data are among the first to examine hoarding among youth with ASD; implications of study findings and future directions are highlighted.

  19. Molecular genetics of Turner syndrome: correlation with clinical phenotype and response to growth hormone therapy.

    Science.gov (United States)

    Tsezou, A; Hadjiathanasiou, C; Gourgiotis, D; Galla, A; Kavazarakis, E; Pasparaki, A; Kapsetaki, M; Sismani, C; Theodoridis, C; Patsalis, P C; Moschonas, N; Kitsiou, S

    1999-12-01

    To correlate the origin of the retained X in Turner syndrome with phenotype, pre-treatment height and response to recombinant human growth hormone (rhGH) therapy, systematic clinical assessment and molecular studies were carried out in 33 Greek children with Turner syndrome and their parents including 18 children with 45,X and 15 with X-mosaicism. Microsatellite markers on X chromosomes (DXS101 and DXS337) revealed that the intact X was paternal (Xp) in 15/30 and maternal (Xm) in 15/30 children, while 3/33 families were non-informative. No significant relationship was found between parental origin of the retained X and birth weight/length/gestational age, blepharoptosis, pterygium colli, webbed neck, low hairline, abnormal ears, lymphoedema, short 4th metacarpal, shield chest, widely spaced nipples, cubitus valgus, pigmented naevi, streak gonads, and cardiovascular/renal anomalies. With regard to the children's pre-treatment height, there was a significant correlation with maternal height and target height in both Xm and Xp groups. No differences were found between Xm and Xp groups and the improvement of growth velocity (GV) during the first and second year of rhGH administration, while for both groups GV significantly improved with rhGH by the end of the first and the second year. To our knowledge, this is the first attempt to correlate the parental origin of Turner syndrome with the response to rhGH therapy.

  20. Goods and Persons, Reasons and Responsibilities

    NARCIS (Netherlands)

    D.R. Gasper (Des)

    2007-01-01

    markdownabstractAbstract Purpose: An exploration of themes that interconnect six studies in environmentally and socially sustainable human development. Findings: As humanity threatens to undermine its habitat, a social economics returns to core concepts and themes that became expunged

  1. Effects of diabetes mellitus on the clinical presentation and treatment response in tuberculosis.

    Science.gov (United States)

    Leung, Chi C; Yew, Wing W; Mok, Thomas Y W; Lau, Kam S; Wong, Chi F; Chau, Chi H; Chan, Chi K; Chang, Kwok C; Tam, Greta; Tam, Cheuk M

    2017-08-01

    With the colliding global epidemics of diabetes mellitus (DM) and tuberculosis (TB), we studied the effects of DM on the presentation of TB and its response to treatment. Consecutive TB patients from 2006 to 2010 in a territory-wide treatment programme offering 9-month extended treatment for TB patients with DM were examined and followed up prospectively to assess their treatment response. Successful treatment completers were tracked through the TB registry and death registry for relapse, death or till 31 December 2014, whichever was the earliest. DM was independently associated with more chest symptoms (adjusted OR (AOR): 1.13) and systemic symptoms (AOR: 1.30) but less with other site-specific symptoms (AOR: 0.58) at TB presentation. There was more frequent pulmonary involvement (AOR: 1.69), with more extensive lung lesion (AOR: 1.25), lung cavity (AOR: 2.00) and positive sputum smear (AOR: 1.83) and culture (AOR: 1.38), but no difference in the proportion of retreatment cases or isoniazid and/or rifampicin resistance. After treatment initiation, there was higher overall incidence (AOR: 1.38) of adverse effects (mainly gastrointestinal symptoms, renal impairment and peripheral neuropathy but less fever and skin hypersensitivity reactions), more smear non-conversion (AOR: 1.59) and culture non-conversion (AOR: 1.40) at 2 months, and lower combined cure/treatment completion rate at 12 months (AOR: 0.79), but no difference in the relapse rate after having successfully completed treatment. DM adversely affected the clinical presentation and treatment response of TB, but there was no difference in the drug resistance and relapse rates. © 2017 Asian Pacific Society of Respirology.

  2. Depth of Response in Multiple Myeloma: A Pooled Analysis of Three PETHEMA/GEM Clinical Trials.

    Science.gov (United States)

    Lahuerta, Juan-Jose; Paiva, Bruno; Vidriales, Maria-Belen; Cordón, Lourdes; Cedena, Maria-Teresa; Puig, Noemi; Martinez-Lopez, Joaquin; Rosiñol, Laura; Gutierrez, Norma C; Martín-Ramos, María-Luisa; Oriol, Albert; Teruel, Ana-Isabel; Echeveste, María-Asunción; de Paz, Raquel; de Arriba, Felipe; Hernandez, Miguel T; Palomera, Luis; Martinez, Rafael; Martin, Alejandro; Alegre, Adrian; De la Rubia, Javier; Orfao, Alberto; Mateos, María-Victoria; Blade, Joan; San-Miguel, Jesus F

    2017-09-01

    Purpose To perform a critical analysis on the impact of depth of response in newly diagnosed multiple myeloma (MM). Patients and Methods Data were analyzed from 609 patients who were enrolled in the GEM (Grupo Español de Mieloma) 2000 and GEM2005MENOS65 studies for transplant-eligible MM and the GEM2010MAS65 clinical trial for elderly patients with MM who had minimal residual disease (MRD) assessments 9 months after study enrollment. Median follow-up of the series was 71 months. Results Achievement of complete remission (CR) in the absence of MRD negativity was not associated with prolonged progression-free survival (PFS) and overall survival (OS) compared with near-CR or partial response (median PFS, 27, 27, and 29 months, respectively; median OS, 59, 64, and 65 months, respectively). MRD-negative status was strongly associated with prolonged PFS (median, 63 months; P < .001) and OS (median not reached; P < .001) overall and in subgroups defined by prior transplantation, disease stage, and cytogenetics, with prognostic superiority of MRD negativity versus CR particularly evident in patients with high-risk cytogenetics. Accordingly, Harrell C statistics showed higher discrimination for both PFS and OS in Cox models that included MRD (as opposed to CR) for response assessment. Superior MRD-negative rates after different induction regimens anticipated prolonged PFS. Among 34 MRD-negative patients with MM and a phenotypic pattern of bone marrow involvement similar to monoclonal gammopathy of undetermined significance at diagnosis, the probability of "operational cure" was high; median PFS was 12 years, and the 10-year OS rate was 94%. Conclusion Our results demonstrate that MRD-negative status surpasses the prognostic value of CR achievement for PFS and OS across the disease spectrum, regardless of the type of treatment or patient risk group. MRD negativity should be considered as one of the most relevant end points for transplant-eligible and elderly fit patients

  3. GENetic and clinical Predictors Of treatment response in Depression: the GenPod randomised trial protocol

    Directory of Open Access Journals (Sweden)

    O'Donovan Michael

    2008-05-01

    Full Text Available Abstract Background The most effective pharmacological treatments for depression inhibit the transporters that reuptake serotonin (Selective Serotonin Reuptake Inhibitors – SSRIs and noradrenaline (Noradrenaline Reuptake Inhibitors – NaRIs into the presynaptic terminal. There is evidence to suggest that noradrenaline and serotonin enhancing drugs work through separate mechanisms to produce their clinical antidepressant action. Although most of the current evidence suggests there is little difference in overall efficacy between SSRIs and NaRIs, there are patients who respond to one class of compounds and not another. This suggests that treatment response could be predicted by genetic and/or clinical characteristics. Firstly, this study aims to investigate the influence of a polymorphism (SLC6A4 in the 5HT transporter in altering response to SSRI medication. Secondly, the study will investigate whether those with more severe depression have a better response to NaRIs than SSRIs. Methods/design The GenPod trial is a multi-centre randomised controlled trial. GPs referred patients aged between 18–74 years presenting with a new episode of depression, who did not have any medical contraindications to antidepressant medication and who had no history of psychosis or alcohol/substance abuse. Patients were interviewed to ascertain their suitability for the study. Eligible participants (with a primary diagnosis of depression according to ICD10 criteria and a Beck Depression Inventory (BDI score > 14 were randomised to receive one of two antidepressant treatments, either the SSRI Citalopram or the NaRI Reboxetine, stratified according to severity. The final number randomised to the trial was 601. Follow-up assessments took place at 2, 6 and 12 weeks following randomisation. Primary outcome was measured at 6 weeks by the BDI. Outcomes will be analysed on an intention-to-treat basis and will use multiple regression models to compare treatments

  4. Analysis of the response of PVA-GTA Fricke-gel dosimeters with clinical magnetic resonance imaging

    Science.gov (United States)

    Collura, Giorgio; Gallo, Salvatore; Tranchina, Luigi; Abbate, Boris Federico; Bartolotta, Antonio; d'Errico, Francesco; Marrale, Maurizio

    2018-01-01

    Fricke gel dosimeters produced with a matrix of Poly-vinyl alcohol (PVA) cross-linked with glutaraldehyde (GTA) were analyzed with magnetic resonance imaging (MRI). Previous studies based on spectrophotometry showed valuable dosimetric features of these gels in terms of X-ray sensitivity and diffusion of the ferric ions produced after irradiation. In this study, MRI was performed on the gels at 1.5 T with a clinical scanner in order to optimize the acquisition parameters and obtain high contrast between irradiated and non-irradiated samples. The PVA gels were found to offer good linearity in the range of 0-10 Gy and a stable signal for several hours after irradiation. The sensitivity was about 40% higher compared to gels produced with agarose as gelling agent. The effect of xylenol orange (XO) on the MRI signal was also investigated: gel dosimeters made without XO show higher sensitivity to x-rays than those made with XO. The dosimetric accuracy of the 3D gels was investigated by comparing their MRI response to percentage depth dose and transversal dose profile measurements made with an ionization chamber in a water phantom. The comparison of PVA-GTA gels with and without XO showed that the chelating agent reduces the MRI sensitivity of the gels. Depth-dose and transversal dose profiles acquired by PVA-GTA gels without XO are more accurate and consistent with the ionization chamber data. However, diffusion effects hinder accurate measurements in the steep dose gradient regions and they should be further reduced by modifying the gel matrix and/or by minimizing the delay between irradiation and imaging.

  5. Adalimumab (Humira) restores clinical response in patients with secondary loss of efficacy from infliximab (Remicade) or etanercept (Enbrel): results from the STURE registry at Karolinska University Hospital.

    Science.gov (United States)

    Wick, M C; Ernestam, S; Lindblad, S; Bratt, J; Klareskog, L; van Vollenhoven, R F

    2005-01-01

    To determine whether the tumour necrosis factor-alpha (TNF-alpha) antagonist adalimumab (Humira) can be efficacious after secondary loss of efficacy (i.e. loss of clinical response in patients who had initially demonstrated clinical response) to infliximab (Remicade) or etanercept (Enbrel). We studied 36 patients from the Stockholm TNF-alpha follow-up registry (STURE) who received adalimumab after secondary loss of efficacy to infliximab (group A, n = 27) or etanercept (group B, n = 9), and 26 patients who were started on adalimumab as the first TNF-alpha antagonist (group C). In group A, the baseline disease activity score 28 (DAS28) at infliximab institution was 5.5+/-0.2. During infliximab treatment, the mean best DAS28 was 3.7+/-0.2 (p<0.001), but increased to 5.2+/-0.3 when infliximab was stopped. After 3 months on adalimumab, the mean DAS28 decreased to 4.5+/-0.3 (p<0.003), and then to 4.2+/-0.2 at 6 months (p<0.001). In group B, the baseline DAS28 at etanercept institution was 6.6+/-0.5. During etanercept treatment, the mean best DAS28 was 4.6+/-0.5 (p<0.01), but increased to 5.7+/-0.4 by the time etanercept was stopped. After 3 months on adalimumab, the mean DAS28 decreased to 4.8+/-0.3 (p<0.005), and to 4.1+/-0.2 at 6 months (p<0.001). In group C, the mean baseline DAS28 was 5.6+/-0.3. After 6 months of adalimumab therapy, the DAS28 decreased to 3.5+/-0.4 (p<0.001). ACR20 responses with adalimumab in groups A, B, and C were similar (70-78%). For patients with secondary loss of efficacy from infliximab or etanercept, switching to adalimumab can restore a good clinical response.

  6. The new criteria of clinical response for the primary tumor based on the findings of histological response after chemoradiation therapy in esophageal cancer

    International Nuclear Information System (INIS)

    Okumura, Hiroshi; Natsugoe, Shoji; Yokomakura, Naoya; Matsumoto, Masataka; Aikou, Takashi

    2005-01-01

    The incidence of chemoradiation therapy (CRT) increased in order to improve the surgical resectabilty and clinical outcome. It is important to accurately assess the effect of CRT for selecting further treatment and predicting prognosis. We tried to make the new criteria for imaging diagnosis after we reevaluated the discrepancy between clinical and histological effect of CRT. Subjects were 36 patients with advanced esophageal cancer who underwent esophagectomy with lymphadenectomy after CRT that consisted of 5-fluorouracil plus cisplatin and 40 Gy of radiation. The clinical and histological response was firstly evaluated based on esophageal disease guidelines for clinical and pathologic studies on carcinoma of the esophagus by the Japanese Society of Clinical response in imaging was reassessed based on the histological response. The number of tumors judged as clinical complete response/partial response/no change (CR/PR/NC) was 0/26/10, and the histological grading 1/2/3 was 17/11/8, respectively. Imaging for Grade 1 tumors showed the existence of viable cancer cells in biopsy specimen. Of 16 patients with such finding, 14 (88%) were histologically judged as Grade 1. Imaging characteristics for grade 3 tumors was more than a 75% reduction in esophagography, and the existence of scar formation by esophagoscopy. All five (100%) patients with these findings were histologically judged as Grade 3. The findings of grade 1 and 3 based on new criteria were independent predictive factors for CRT effect. According to new criteria, it was possible to predict the histological effect by the combination of esophagography and endoscopy in more than 80% of patients after CRT. Our new criteria may offer important information on the selection of further treatment or the prediction of prognosis after CRT in patients with esophageal cancer. (author)

  7. Transferring responsibility and accountability in maternity care: clinicians defining their boundaries of practice in relation to clinical handover

    Science.gov (United States)

    Chin, Georgiana S M; Warren, Narelle; Kornman, Louise; Cameron, Peter

    2012-01-01

    Objective This exploratory study reports on maternity clinicians’ perceptions of transfer of their responsibility and accountability for patients in relation to clinical handover with particular focus transfers of care in birth suite. Design A qualitative study of semistructured interviews and focus groups of maternity clinicians was undertaken in 2007. De-indentified data were transcribed and coded using the constant comparative method. Multiple themes emerged but only those related to responsibility and accountability are reported in this paper. Setting One tertiary Australian maternity hospital. Participants Maternity care midwives, nurses (neonatal, mental health, bed managers) and doctors (obstetric, neontatology, anaesthetics, internal medicine, psychiatry). Primary outcome measures Primary outcome measures were the perceptions of clinicians of maternity clinical handover. Results The majority of participants did not automatically connect maternity handover with the transfer of responsibility and accountability. Once introduced to this concept, they agreed that it was one of the roles of clinical handover. They spoke of complete transfer, shared and ongoing responsibility and accountability. When clinicians had direct involvement or extensive clinical knowledge of the patient, blurring of transition of responsibility and accountability sometimes occurred. A lack of ‘ownership’ of a patient and their problems were seen to result in confusion about who was to address the clinical issues of the patient. Personal choice of ongoing responsibility and accountability past the handover communication were described. This enabled the off-going person to rectify an inadequate handover or assist in an emergency when duty clinicians were unavailable. Conclusions There is a clear lack of consensus about the transition of responsibility and accountability—this should be explicit at the handover. It is important that on each shift and new workplace environment

  8. A quick behavioral dichotic word test is prognostic for clinical response to cognitive therapy for depression: A replication study.

    Science.gov (United States)

    Bruder, Gerard E; Haggerty, Agnes; Siegle, Greg J

    2017-02-01

    There are no commonly used clinical indicators of whether an individual will benefit from cognitive therapy (CT) for depression. A prior study found right ear (left hemisphere) advantage for perceiving dichotic words predicted CT response. This study replicates this finding at a different research center in clinical trials that included clinically representative samples and community therapists. Right-handed individuals with unipolar major depressive disorder who subsequently received 12-14 weeks of CT at the University of Pittsburgh were tested on dichotic fused words and complex tones tests. Responders to CT showed twice the mean right ear advantage in dichotic fused words performance than non-responders. Patients with a right ear advantage greater than the mean for healthy controls had an 81% response rate to CT, whereas those with performance lower than the mean for controls had a 46% response rate. Individuals with a right ear advantage, indicative of strong left hemisphere language dominance, may be better at utilizing cognitive processes and left frontotemporal cortical regions critical for success of CT for depression. Findings at two clinical research centers suggest that verbal dichotic listening may be a clinically disseminative brief, inexpensive and easily automated test prognostic for response to CT across diverse clinical settings. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. The 20th anniversary of interleukin-2 therapy: bimodal role explaining longstanding random induction of complete clinical responses

    International Nuclear Information System (INIS)

    Coventry, Brendon J; Ashdown, Martin L

    2012-01-01

    This year marks the twentieth anniversary of the approval by the US Food and Drug Administration of interleukin-2 (IL2) for use in cancer therapy, initially for renal cell carcinoma and later for melanoma. IL2 therapy for cancer has stood the test of time, with continued widespread use in Europe, parts of Asia, and the US. Clinical complete responses are variably reported at 5%–20% for advanced malignant melanoma and renal cell carcinoma, with strong durable responses and sustained long-term 5–10-year survival being typical if complete responses are generated. The literature was reviewed for the actions and clinical effects of IL2 on subsets of T cells. The influence of IL2 on clinical efficacy was also sought. The review revealed that IL2 is capable of stimulating different populations of T cells in humans to induce either T effector or T regulatory responses. This apparent “functional paradox” has confounded a clear understanding of the mechanisms behind the clinical effects that are observed during and following administration of IL2 therapy. An average complete response rate of around 7% in small and large clinical trials using IL2 for advanced renal cell carcinoma and malignant melanoma has been shown from a recent review of the literature. This review considers the published literature concerning the actions and emerging clinical effects of IL2 therapy, spanning its 20-year period in clinical use. It further details some of the recently described “bimodal” effects of IL2 to explain the apparent functional paradox, and how IL2 might be harnessed to emerge rapidly as a much more effective and predictable clinical agent in the near future

  10. Estimating the clinical and economic benefit associated with incremental improvements in sustained virologic response in chronic hepatitis C.

    Science.gov (United States)

    McEwan, Phil; Ward, Thomas; Bennett, Hayley; Kalsekar, Anupama; Webster, Samantha; Brenner, Michael; Yuan, Yong

    2015-01-01

    Hepatitis C virus (HCV) infection is one of the principle causes of chronic liver disease. Successful treatment significantly decreases the risk of hepatic morbidity and mortality. Current standard of care achieves sustained virologic response (SVR) rates of 40-80%; however, the HCV therapy landscape is rapidly evolving. The objective of this study was to quantify the clinical and economic benefit associated with increasing levels of SVR. A published Markov model (MONARCH) that simulates the natural history of hepatitis C over a lifetime horizon was used. Discounted and non-discounted life-years (LYs), quality-adjusted life-years (QALYs) and cost of complication management were estimated for various plausible SVR rates. To demonstrate the robustness of projections obtained, the model was validated to ten UK-specific HCV studies. QALY estimates ranged from 18.0 years for those treated successfully in fibrosis stage F0 to 7.5 years (discounted) for patients in fibrosis stage F4 who remain untreated. Predicted QALY gains per 10% improvement in SVR ranged from 0.23 (F0) to 0.64 (F4) and 0.58 (F0) to 1.35 (F4) in 40 year old patients (discounted and non-discounted results respectively). In those aged 40, projected discounted HCV-related costs are minimised with successful treatment in F0/F1 (at approximately £ 300), increasing to £ 49,300 in F4 patients who remain untreated. Validation of the model to published UK cost-effectiveness studies produce R2 goodness of fit statistics of 0.988, 0.978 and of 0.973 for total costs, QALYs and incremental cost effectiveness ratios, respectively. Projecting the long-term clinical and economic consequences associated with chronic hepatitis C is a necessary requirement for the evaluation of new treatments. The principle analysis demonstrates the significant impact on expected costs, LYs and QALYs associated with increasing SVR. A validation analysis demonstrated the robustness of the results reported.

  11. Clinical response and safety of malathion shampoo for treatment of head lice in a primary school.

    Science.gov (United States)

    Wananukul, Siriwan; Chatproedprai, Susheera; Tempark, Therdpong; Wananukul, Winai

    2011-04-01

    Help eradicate or at least alleviating head lice in a primary school with malathion shampoo and to study clinical response and safety of malathion shampoo. All students were examined by using a fine-toothed lice comb to help detect live lice. Direct visual examination and the collection of nits for microscopic examination were performed to differentiate viable nits from empty nits. Diagnosis of head lice was made by the presence of lice. All students that had lice and/or nits were treated with malathion shampoo. Malathion shampoo was also provided for all family members. Pediculocidal efficacy was by the presence or absence of live lice. Blood for red blood cell cholinesterase activity was drawn in 32 volunteers before treatment and after the second treatment. At the first visit, 629 students were examined and 48 students had live head lice. The infestation rate was 13% in girls and 1.3% in boys. The cure rate was 93% after the first treatment. The reported side effects were nausea, a burning sensation, and irritation that was found in five (4%), 10 (7%) and three (2%) students respectively. The mean of RBC cholinesterase activity before and after two applications showed significant changes (p = 0.03). It was -7.5 +/- 4.1% reduction from the initial, but all were in the normal range. There was no report of clinical manifestation of malathion toxicity. Malathion shampoo is safe and effective in the treatment of head lice. There is significant skin absorption so a scalp examination for head lice should be done before subsequent application to avoid unnecessary exposure.

  12. Assessment of and Response to Data Needs of Clinical and Translational Science Researchers and Beyond

    Directory of Open Access Journals (Sweden)

    Hannah F. Norton

    2016-04-01

    Full Text Available Objective and Setting: As universities and libraries grapple with data management and “big data,” the need for data management solutions across disciplines is particularly relevant in clinical and translational science (CTS research, which is designed to traverse disciplinary and institutional boundaries. At the University of Florida Health Science Center Library, a team of librarians undertook an assessment of the research data management needs of CTS researchers, including an online assessment and follow-up one-on-one interviews. Design and Methods: The 20-question online assessment was distributed to all investigators affiliated with UF’s Clinical and Translational Science Institute (CTSI and 59 investigators responded. Follow-up in-depth interviews were conducted with nine faculty and staff members. Results: Results indicate that UF’s CTS researchers have diverse data management needs that are often specific to their discipline or current research project and span the data lifecycle. A common theme in responses was the need for consistent data management training, particularly for graduate students; this led to localized training within the Health Science Center and CTSI, as well as campus-wide training. Another campus-wide outcome was the creation of an action-oriented Data Management/Curation Task Force, led by the libraries and with participation from Research Computing and the Office of Research. Conclusions: Initiating conversations with affected stakeholders and campus leadership about best practices in data management and implications for institutional policy shows the library’s proactive leadership and furthers our goal to provide concrete guidance to our users in this area.

  13. X-linked Acrogigantism (X-LAG) Syndrome: Clinical Profile and Therapeutic Responses

    Science.gov (United States)

    Beckers, Albert; Lodish, Maya Beth; Trivellin, Giampaolo; Rostomyan, Liliya; Lee, Misu; Faucz, Fabio R; Yuan, Bo; Choong, Catherine S; Caberg, Jean-Hubert; Verrua, Elisa; Naves, Luciana Ansaneli; Cheetham, Tim D; Young, Jacques; Lysy, Philippe A; Petrossians, Patrick; Cotterill, Andrew; Shah, Nalini Samir; Metzger, Daniel; Castermans, Emilie; Ambrosio, Maria Rosaria; Villa, Chiara; Strebkova, Natalia; Mazerkina, Nadia; Gaillard, Stéphan; Barra, Gustavo Barcelos; Casulari, Luis Augusto; Neggers, Sebastian J.; Salvatori, Roberto; Jaffrain-Rea, Marie-Lise; Zacharin, Margaret; Santamaria, Beatriz Lecumberri; Zacharieva, Sabina; Lim, Ee Mun; Mantovani, Giovanna; Zatelli, Maria Chaira; Collins, Michael T; Bonneville, Jean-François; Quezado, Martha; Chittiboina, Prashant; Oldfield, Edward H.; Bours, Vincent; Liu, Pengfei; De Herder, Wouter; Pellegata, Natalia; Lupski, James R.; Daly, Adrian F.; Stratakis, Constantine A.

    2015-01-01

    X-linked acro-gigantism (X-LAG) is a new syndrome of pituitary gigantism, caused by microduplications on chromosome Xq26.3, encompassing the gene GPR101, which is highly upregulated in pituitary tumors. We conducted this study to explore the clinical, radiological and hormonal phenotype and responses to therapy in patients with X-LAG syndrome. The study included 18 patients (13 sporadic) with X-LAG and a microduplication in chromosome Xq26.3. All sporadic cases had unique duplications and the inheritance pattern in 2 families was dominant with all Xq26.3 duplication carriers being affected. Patients began to grow rapidly as early as 2–3 months of age (median 12 months). At diagnosis (median delay 27 months), patients had a median height and weight SDS score of >+3.9 SDS. Apart from the increased overall body size, the children had acromegalic symptoms including acral enlargement and facial coarsening. More than a third of cases had increased appetite. Patients had marked hypersecretion of GH/IGF-1 and prolactin, usually due to a pituitary macroadenoma or hyperplasia. Primary neurosurgical control was achieved with extensive anterior pituitary resection but postoperative hypopituitarism was frequent. Control with somatostatin analogs was not readily achieved despite moderate to high somatostatin receptor subtype-2 expression in tumor tissue. Postoperative adjuvant pegvisomant achieved control of IGF-1 all 5 cases in which it was employed. X-LAG is a new infant-onset gigantism syndrome that has a severe clinical phenotype leading to challenging disease management. PMID:25712922

  14. Refractory myasthenia gravis – clinical profile, comorbidities and response to rituximab

    Science.gov (United States)

    Sudulagunta, Sreenivasa Rao; Sepehrar, Mona; Sodalagunta, Mahesh Babu; Settikere Nataraju, Aravinda; Bangalore Raja, Shiva Kumar; Sathyanarayana, Deepak; Gummadi, Siddharth; Burra, Hemanth Kumar

    2016-01-01

    Introduction: Myasthenia gravis (MG) is an antibody mediated autoimmune neuromuscular disorder characterized by fatigable muscle weakness. A proportion of myasthenia gravis patients are classified as refractory due to non responsiveness to conventional treatment. This retrospective study was done to evaluate clinical profile, epidemiological, laboratory, and features of patients with MG and mode of management using rituximab and complications. Methods: Data of myasthenia gravis patients admitted or presented to outpatient department (previous medical records) with MG between January 2008 and January 2016 were included. A total of 512 patients fulfilled the clinical and diagnostic criteria of myasthenia gravis of which 76 patients met the diagnostic certainty for refractory myasthenia gravis and were evaluated. Results: Out of 76 refractory MG patients, 53 (69.73%) patients fulfilled all the three defined criteria. The median age of onset of the refractory MG group was 36 years with a range of 27–53 years. In our study 25 patients (32.89%) belonged to the age group of 21–30 years. Anti-MuSK antibodies were positive in 8 non-refractory MG patients (2.06%) and 36 refractory MG patients (47.36%). Mean HbA1C was found to be 8.6±2.33. The dose of administered prednisone decreased by a mean of 59.7% (p=3.3x10–8) to 94.6% (p=2.2x10–14) after the third cycle of rituximab treatment. Conclusion: The refractory MG patients are most commonly female with an early age of onset, anti-MuSK antibodies, and thymomas. Refractory MG patients have higher prevalence and poor control (HbA1C >8%) of diabetes mellitus and dyslipidemia probably due to increased steroid usage. Rituximab is very efficient in treatment of refractory MG with adverse effects being low. PMID:27790079

  15. Discordant Immune Response with Antiretroviral Therapy in HIV-1: A Systematic Review of Clinical Outcomes

    Science.gov (United States)

    Kelly, Christine; Gaskell, Katherine M.; Richardson, Marty; Klein, Nigel; Garner, Paul; MacPherson, Peter

    2016-01-01

    Background A discordant immune response (DIR) is a failure to satisfactorily increase CD4 counts on ART despite successful virological control. Literature on the clinical effects of DIR has not been systematically evaluated. We aimed to summarise the risk of mortality, AIDS and serious non-AIDS events associated with DIR with a systematic review. Methods The protocol is registered with the Centre for Review Dissemination, University of York (registration number CRD42014010821). Included studies investigated the effect of DIR on mortality, AIDS, or serious non-AIDS events in cohort studies or cohorts contained in arms of randomised controlled trials for adults aged 16 years or older. DIR was classified as a suboptimal CD4 count (as defined by the study) despite virological suppression following at least 6 months of ART. We systematically searched PubMed, Embase, and the Cochrane Library to December 2015. Risk of bias was assessed using the Cochrane tool for assessing risk of bias in cohort studies. Two authors applied inclusion criteria and one author extracted data. Risk ratios were calculated for each clinical outcome reported. Results Of 20 studies that met the inclusion criteria, 14 different definitions of DIR were used. Risk ratios for mortality in patients with and without DIR ranged between 1.00 (95% CI 0.26 to 3.92) and 4.29 (95% CI 1.96 to 9.38) with the majority of studies reporting a 2 to 3 fold increase in risk. Conclusions DIR is associated with a marked increase in mortality in most studies but definitions vary widely. We propose a standardised definition to aid the development of management options for DIR. PMID:27284683

  16. Discordant Immune Response with Antiretroviral Therapy in HIV-1: A Systematic Review of Clinical Outcomes.

    Directory of Open Access Journals (Sweden)

    Christine Kelly

    Full Text Available A discordant immune response (DIR is a failure to satisfactorily increase CD4 counts on ART despite successful virological control. Literature on the clinical effects of DIR has not been systematically evaluated. We aimed to summarise the risk of mortality, AIDS and serious non-AIDS events associated with DIR with a systematic review.The protocol is registered with the Centre for Review Dissemination, University of York (registration number CRD42014010821. Included studies investigated the effect of DIR on mortality, AIDS, or serious non-AIDS events in cohort studies or cohorts contained in arms of randomised controlled trials for adults aged 16 years or older. DIR was classified as a suboptimal CD4 count (as defined by the study despite virological suppression following at least 6 months of ART. We systematically searched PubMed, Embase, and the Cochrane Library to December 2015. Risk of bias was assessed using the Cochrane tool for assessing risk of bias in cohort studies. Two authors applied inclusion criteria and one author extracted data. Risk ratios were calculated for each clinical outcome reported.Of 20 studies that met the inclusion criteria, 14 different definitions of DIR were used. Risk ratios for mortality in patients with and without DIR ranged between 1.00 (95% CI 0.26 to 3.92 and 4.29 (95% CI 1.96 to 9.38 with the majority of studies reporting a 2 to 3 fold increase in risk.DIR is associated with a marked increase in mortality in most studies but definitions vary widely. We propose a standardised definition to aid the development of management options for DIR.

  17. Cerebral venous thrombosis in Saudi Arabia. Clinical variables, response to treatment, and outcome

    International Nuclear Information System (INIS)

    Kajtazi, Naim I; Arulneyam, Jayanthi C; AlSenani, Fahmi M; Zimmerman, Valerie A; AlShami, Sadiq Y

    2009-01-01

    To investigate cerebral venous thrombosis (CVTR) clinical presentations, risk factors, and response to treatment in Saudi Arabia. Retrospective analysis of the King Farad Medical City, Riyadh, acute stroke database from April 2005 through February 2008 revealed 22 patients with CVTR. Hyper coagulable work-up and neuroimaging were performed. Sixteen patients were female (72.7%), and the median age was 35 years. Clinical presentations included: headache (77.3%), seizures (54.5%), focal neurological signs (54.5%), and decreased level of consciousness (50%). Over two-thirds (n=11; 69%) of female patients had a history of oral contraceptive use, which was the most common risk factor. Protein S deficiency (n=3), anti phospholipid antibody syndrome secondary to systemic lupus erythematosus (SLE) (n=1), rhinocerebral mucormycosis (n=1), leukemia (n=1), non-Hodgkin's lymphoma (n=1), sepsis (n=1), and unknown (n=6) were causes. Affected areas included superior sagittal (n=13), transverse (n=16), sigmoid (n=14), straight (n=6), and cavernous sinus (n=1); internal cerebral vein (n=2); vein of Galen (n=3); cortical veins (n=10); and internal jugular vein (n=12). Two patients had quadriparesis, and 2 patients died. The remainder (n=18, 81.8%) improved. Bilateral hemorrhagic presentation or venous infarction, deep venous system thrombosis, and underlying malignancy had less favorable results. Presentations in our series were similar to those in other reports, although altered consciousness and seizures were more common. Cortical vein involvement was also higher than commonly reported. Oral contraceptive use was a primary risk factor in female patients. Outcomes were favorable in 81.8% of patients. (author)

  18. Radiation response in vitro of fibroblasts from a Fanconi anemia patient with marked clinical radiosensitivity

    Energy Technology Data Exchange (ETDEWEB)

    Djuzenova, C.; Flentje, M. [Dept. of Radiotherapy, Univ. of Wuerzburg, Wuerzburg (Germany); Plowman, P.N. [Radiotherapy/Clinical Oncology, St. Bartholomew' s Hospital, London (United Kingdom)

    2004-12-01

    Background: fanconi anemia (FA) is an autosomal recessive chromosome instability disorder characterized by progressive pancytopenia and cancer susceptibility. The risks of radiation therapy in FA patients who have cancer remain to be investigated. Recently, Marcou et al. (2001) reported a case of severe clinical radiosensitivity in a female FA patient with a tonsillar squamous cell carcinoma treated by radiotherapy. By contrast, her in vitro irradiated skin fibroblasts revealed nearly normal radiosensitivity as determined by the colony survival assay. Material and methods: in view of this discrepancy, the radiation response of this particular FA fibroblast strain (designated 425BR) was further analyzed in the present study by means of the alkaline single-cell gel electrophoresis (Comet) assay, and also by the cytochalasin-blocked micronuclei (MN) test. In addition, the expression levels of DNA repair proteins, hMre11, Rad50, and Rad51, were investigated using Western blot and foci immunofluorescence staining. Results: the Comet assay revealed that the initial DNA fragmentation in irradiated FA cells was two times higher and the DNA rejoining process was three times slower than that in control (1BR3) fibroblasts. Moreover, although the baseline level of MNs was lower in FA cells than in controls, the FA fibroblasts were more prone (about two times) to MN production than control cells when irradiated with 2-4 Gy. Western blot analysis of the DNA repair proteins (hMre11, Rad50, and Rad51) did not reveal any abnormalities in protein expression levels or their migration patterns in the fibroblasts derived from an FA patient either before or after irradiation. At the same time, in vitro irradiated cells from the FA patient exhibited a significantly reduced number of nuclei with focally concentrated DNA repair Rad51 protein than in control cells. Conclusion: the increased DNA damage and MN induction in irradiated FA fibroblasts, and the reduction of the formation of DNA

  19. Radiation response in vitro of fibroblasts from a Fanconi anemia patient with marked clinical radiosensitivity

    International Nuclear Information System (INIS)

    Djuzenova, C.; Flentje, M.; Plowman, P.N.

    2004-01-01

    Background: fanconi anemia (FA) is an autosomal recessive chromosome instability disorder characterized by progressive pancytopenia and cancer susceptibility. The risks of radiation therapy in FA patients who have cancer remain to be investigated. Recently, Marcou et al. (2001) reported a case of severe clinical radiosensitivity in a female FA patient with a tonsillar squamous cell carcinoma treated by radiotherapy. By contrast, her in vitro irradiated skin fibroblasts revealed nearly normal radiosensitivity as determined by the colony survival assay. Material and methods: in view of this discrepancy, the radiation response of this particular FA fibroblast strain (designated 425BR) was further analyzed in the present study by means of the alkaline single-cell gel electrophoresis (Comet) assay, and also by the cytochalasin-blocked micronuclei (MN) test. In addition, the expression levels of DNA repair proteins, hMre11, Rad50, and Rad51, were investigated using Western blot and foci immunofluorescence staining. Results: the Comet assay revealed that the initial DNA fragmentation in irradiated FA cells was two times higher and the DNA rejoining process was three times slower than that in control (1BR3) fibroblasts. Moreover, although the baseline level of MNs was lower in FA cells than in controls, the FA fibroblasts were more prone (about two times) to MN production than control cells when irradiated with 2-4 Gy. Western blot analysis of the DNA repair proteins (hMre11, Rad50, and Rad51) did not reveal any abnormalities in protein expression levels or their migration patterns in the fibroblasts derived from an FA patient either before or after irradiation. At the same time, in vitro irradiated cells from the FA patient exhibited a significantly reduced number of nuclei with focally concentrated DNA repair Rad51 protein than in control cells. Conclusion: the increased DNA damage and MN induction in irradiated FA fibroblasts, and the reduction of the formation of DNA

  20. Doing Good Parenthood

    DEFF Research Database (Denmark)

    This edited collection shows that good parenthood is neither fixed nor stable. The contributors show how parenthood is equally done by men, women and children, in and through practices involving different normative guidelines. The book explores how normative layers of parenthood are constituted...... by notions such as good childhood, family ideals, national public health and educational strategies. The authors illustrate how different versions of parenthood coexist and how complex sets of actions are demanded to fulfil today’s expectations of parenthood in Western societies. This interdisciplinary book...

  1. From Goods to Solutions

    DEFF Research Database (Denmark)

    Chakkol, Mehmet; Johnson, Mark; Raja, Jawwad

    2014-01-01

    Purpose – This paper aims to adopt service-dominant logic (SDL) to empirically explore network configurations resulting from the provision of goods, goods and services, and solutions. Design/methodology/approach – This paper uses a single, in-depth, exploratory case study in a truck manufacturer......: dyadic, triadic and tetradic. The extent to which different network actors contribute to value co-creation varies across the offerings. Research limitations/implications – This paper is based on a single, in-depth case study developed in one industrial context. Whilst this represents an appropriate...

  2. Sequential Objective Structured Clinical Examination based on item response theory in Iran

    Directory of Open Access Journals (Sweden)

    Sara Mortaz Hejri

    2017-09-01

    Full Text Available Purpose In a sequential objective structured clinical examination (OSCE, all students initially take a short screening OSCE. Examinees who pass are excused from further testing, but an additional OSCE is administered to the remaining examinees. Previous investigations of sequential OSCE were based on classical test theory. We aimed to design and evaluate screening OSCEs based on item response theory (IRT. Methods We carried out a retrospective observational study. At each station of a 10-station OSCE, the students’ performance was graded on a Likert-type scale. Since the data were polytomous, the difficulty parameters, discrimination parameters, and students’ ability were calculated using a graded response model. To design several screening OSCEs, we identified the 5 most difficult stations and the 5 most discriminative ones. For each test, 5, 4, or 3 stations were selected. Normal and stringent cut-scores were defined for each test. We compared the results of each of the 12 screening OSCEs to the main OSCE and calculated the positive and negative predictive values (PPV and NPV, as well as the exam cost. Results A total of 253 students (95.1% passed the main OSCE, while 72.6% to 94.4% of examinees passed the screening tests. The PPV values ranged from 0.98 to 1.00, and the NPV values ranged from 0.18 to 0.59. Two tests effectively predicted the results of the main exam, resulting in financial savings of 34% to 40%. Conclusion If stations with the highest IRT-based discrimination values and stringent cut-scores are utilized in the screening test, sequential OSCE can be an efficient and convenient way to conduct an OSCE.

  3. Group differences in physician responses to handheld presentation of clinical evidence: a verbal protocol analysis

    Directory of Open Access Journals (Sweden)

    Pavlovic Nada J

    2007-07-01

    Full Text Available Abstract Background To identify individual differences in physicians' needs for the presentation of evidence resources and preferences for mobile devices. Methods Within-groups analysis of responses to semi-structured interviews. Interviews consisted of using prototypes in response to task-based scenarios. The prototypes were implemented on two different form factors: a tablet style PC and a pocketPC. Participants were from three user groups: general internists, family physicians and medicine residents, and from two different settings: urban and semi-urban. Verbal protocol analysis, which consists of coding utterances, was conducted on the transcripts of the testing sessions. Statistical relationships were investigated between staff physicians' and residents' background variables, self-reported experiences with the interfaces, and verbal code frequencies. Results 47 physicians were recruited from general internal medicine, family practice clinics and a residency training program. The mean age of participants was 42.6 years. Physician specialty had a greater effect on device and information-presentation preferences than gender, age, setting or previous technical experience. Family physicians preferred the screen size of the tablet computer and were less concerned about its portability. Residents liked the screen size of the tablet, but preferred the portability of the pocketPC. Internists liked the portability of the pocketPC, but saw less advantage to the large screen of the tablet computer (F[2,44] = 4.94, p = .012. Conclusion Different types of physicians have different needs and preferences for evidence-based resources and handheld devices. This study shows how user testing can be incorporated into the process of design to inform group-based customization.

  4. Sequential Objective Structured Clinical Examination based on item response theory in Iran.

    Science.gov (United States)

    Hejri, Sara Mortaz; Jalili, Mohammad

    2017-01-01

    In a sequential objective structured clinical examination (OSCE), all students initially take a short screening OSCE. Examinees who pass are excused from further testing, but an additional OSCE is administered to the remaining examinees. Previous investigations of sequential OSCE were based on classical test theory. We aimed to design and evaluate screening OSCEs based on item response theory (IRT). We carried out a retrospective observational study. At each station of a 10-station OSCE, the students' performance was graded on a Likert-type scale. Since the data were polytomous, the difficulty parameters, discrimination parameters, and students' ability were calculated using a graded response model. To design several screening OSCEs, we identified the 5 most difficult stations and the 5 most discriminative ones. For each test, 5, 4, or 3 stations were selected. Normal and stringent cut-scores were defined for each test. We compared the results of each of the 12 screening OSCEs to the main OSCE and calculated the positive and negative predictive values (PPV and NPV), as well as the exam cost. A total of 253 students (95.1%) passed the main OSCE, while 72.6% to 94.4% of examinees passed the screening tests. The PPV values ranged from 0.98 to 1.00, and the NPV values ranged from 0.18 to 0.59. Two tests effectively predicted the results of the main exam, resulting in financial savings of 34% to 40%. If stations with the highest IRT-based discrimination values and stringent cut-scores are utilized in the screening test, sequential OSCE can be an efficient and convenient way to conduct an OSCE.

  5. Paying for International Environmental Public Goods

    OpenAIRE

    Arriagada, Rodrigo; Perrings, Charles

    2011-01-01

    Supply of international environmental public goods must meet certain conditions to be socially efficient, and several reasons explain why they are currently undersupplied. Diagnosis of the public goods failure associated with particular ecosystem services is critical to the development of the appropriate international response. There are two categories of international environmental public goods that are most likely to be undersupplied. One has an additive supply technology and the other has ...

  6. Good Governance in the EU

    Directory of Open Access Journals (Sweden)

    Gina Livioara GOGA

    2009-10-01

    Full Text Available Considering the EU adhesion, good governance has been analyzed from different perspectives, in the judicial literature being an analytic model or a normative concept. Some authors have wondered if this concept is a fashion, comprising some older ideas and principles, while other authors have asserted that the reasons why different methods of governance appear in the EU are based on “the complexity and the uncertainty of the problems on the agenda, an irreducible, the new approaches on public administration and law, hidden competencies, legitimacy and subsidiarity”. At a normative level, the White Paper of European Governance consecrated five principles on which good governance is based upon: openness, participation, responsibility, efficiency and coherence.

  7. Knowledge asymmetries about product "goodness"

    DEFF Research Database (Denmark)

    Kampf, Constance

    and actions towards workers, and findings of independent researchers.  Currently, differing perspectives on product "goodness" are being addressed and mediated by NGOs and B-corporations, as they work with private companies and corporations to communicate product information to consumers.  One organization...... focused on scenarios where shoppers were asked about CSR in their product decisions found that: "...when consumers are given information that they trust about a company's level of social responsibility, it affects how they evaluate the company and their purchase intentions. Furthermore, a low price did.......  Asymmetries in knowledge about product "goodness" make it difficult for ethically inspired consumers to make informed decisions about the products they purchase.  These knowledge asymmetries emerge from differing perspectives on guidelines for consumer safety set by government bodies, CSR initiatives...

  8. Transplantation as an abstract good

    DEFF Research Database (Denmark)

    Hoeyer, Klaus; Jensen, Anja Marie Bornø; Olejaz, Maria

    2015-01-01

    This article investigates valuations of organ transfers that are currently seen as legitimising increasingly aggressive procurement methods in Denmark. Based on interviews with registered donors and the intensive care unit staff responsible for managing organ donor patients we identify three types...... a more general salience in the organ transplant field by way of facilitating a perception of organ transplantation as an abstract moral good rather than a specific good for specific people. Furthermore, we suggest that multiple forms of ignorance sustain each other: a desire for ignorance with respect...... to the prioritisation of recipients sustains pressure for more organs; this pressure necessitates more aggressive measures in organ procurement and these measures increase the need for ignorance in relation to the actual procedures as well as the actual recipients. These attempts to avoid knowledge are in remarkable...

  9. Reconsidering the "Good Divorce"

    Science.gov (United States)

    Amato, Paul R.; Kane, Jennifer B.; James, Spencer

    2011-01-01

    This study attempted to assess the notion that a "good divorce" protects children from the potential negative consequences of marital dissolution. A cluster analysis of data on postdivorce parenting from 944 families resulted in three groups: cooperative coparenting, parallel parenting, and single parenting. Children in the cooperative coparenting…

  10. Financial Giffen Goods

    DEFF Research Database (Denmark)

    Poulsen, Rolf; Rasmussen, Kourosh Marjani

    2008-01-01

    In the basic Markowitz and Merton models, a stock’s weight in efficient portfolios goes up if its expected rate of return goes up. Put differently, there are no financial Giffen goods. By an example from mortgage choice we illustrate that for more complicated portfolio problems Giffen effects do...

  11. Good Apple Homework Helper.

    Science.gov (United States)

    Cipriano, Jeri S.

    This book, designed for students in grades 4 to 6, provides advice to help them do homework independently and successfully. Part 1, "Developing Good Habits," presents exercises and tips on organization and time management, including a self-inventory of homework habits, assistance in goal setting, and designing a personal schedule. Part 2, "Getting…

  12. Ecology and the Good

    Science.gov (United States)

    Gustafson, James W.

    1971-01-01

    Our value system relating to the natural sciences is examined for its acceptability and worthiness. Scrutinized are the cognitive meanings about values, validity of values, subjective and cultural relativism, the good of objective realities, and cooperation with natural forces and God. (BL)

  13. Clinical Effects of a Dietary Antioxidant Silicate Supplement, Microhydrin((R)), on Cardiovascular Responses to Exercise.

    Science.gov (United States)

    Purdy Lloyd, Kimberly L.; Wasmund, Wendy; Smith, Leonard; Raven, Peter B.

    2001-01-01

    Amorphous silicate minerals, often described as rock flour, were once common in natural water sources and abundant in glacial stream waters. Not only do the silica mineral particles bond water and other elements for transport; they also can be adsorbed with reduced hydrogen, which releases electrons, providing antioxidant or reducing potential to surrounding fluids. The purpose of this investigation was to examine the cardiovascular responses during exercise after consumption of a dietary silicate mineral antioxidant supplement, Microhydrin((R)) (Royal BodyCare, Inc., Irving, TX). A clinical trial incorporating a double-blind, placebo-controlled, crossover experimental design was employed. Subjects received either active agent or placebo, four capsules per day, for 7 days before the trial. The trial evaluated six exercise bicycle-trained subjects performing a 40-km bicycling time trial. Ratings of perceived exertion and measurements of oxygen uptake, heart rate, performance workload, and preexercise and postexercise blood lactate concentrations were obtained. Although there were no differences (P >/=.05) in work performed, heart rate, oxygen uptake, and ratings of perceived exertion during the time trial, the postexercise blood lactate concentrations were significantly lower (P

  14. Strategic response by providers to specialty hospitals, ambulatory surgery centers, and retail clinics.

    Science.gov (United States)

    Burns, Lawton R; David, Guy; Helmchen, Lorens A

    2011-04-01

    Radical innovation and disruptive technologies are frequently heralded as a solution to delivering higher quality, lower cost health care. According to the literature on disruption, local hospitals and physicians (incumbent providers) may be unable to competitively respond to such "creative destruction" and alter their business models for a host of reasons, thus threatening their future survival. However, strategic management theory and research suggest that, under certain conditions, incumbent providers may be able to weather the discontinuities posed by the disrupters. This article analyzes 3 disruptive innovations in service delivery: single-specialty hospitals, ambulatory surgical centers, and retail clinics. We first discuss the features of these innovations to assess how disruptive they are. We then draw on the literature on strategic adaptation to suggest how incumbents develop competitive responses to these disruptive innovations that assure their continued survival. These arguments are then evaluated in a field study of several urban markets based on interviews with both incumbents and entrants. The interviews indicate that entrants have failed to disrupt incumbent providers primarily as a result of strategies pursued by the incumbents. The findings cast doubt on the prospects for these disruptive innovations to transform health care.

  15. Inhaled corticosteroids do not influence the early inflammatory response and clinical presentation of hospitalized subjects with COPD exacerbation.

    Science.gov (United States)

    Crisafulli, Ernesto; Guerrero, Mónica; Menéndez, Rosario; Huerta, Arturo; Martinez, Raquel; Gimeno, Alexandra; Soler, Néstor; Torres, Antoni

    2014-10-01

    Inhaled corticosteroids are anti-inflammatory medications that can down-regulate the immunologic response in patients with COPD; however, their role at onset of COPD exacerbation is still not understood. The aim of this study was to assess the early inflammatory response and clinical presentation of patients with COPD exacerbation mediated by inhaled corticosteroids. Prospective data were collected on 123 hospitalized subjects with COPD exacerbation over a 30-month period at 2 Spanish university hospitals. Based on domiciliary use, comparative analyses were performed between subjects who did not use inhaled corticosteroids (n = 58) and subjects who did (n = 65). Measurements of serum biomarkers were recorded on admission to the hospital (day 1) and on day 3; clinical, physiological, microbiological, and severity data and mortality/readmission rates were also recorded. At days 1 and 3, both groups showed a similar inflammatory response; fluticasone produced lower levels of interleukin-8 compared with budesonide (P clinical features considered were similar in the 2 groups; multivariate analysis predicting clinical complications on hospitalization showed air-flow obstruction severity as the only predictive factor (odds ratio 3.13, 95% CI 1.13-8.63, P = .02). Our study demonstrates a lack of inhaled corticosteroid influence in the early systemic inflammatory response to and clinical presentation of COPD exacerbation. Copyright © 2014 by Daedalus Enterprises.

  16. Radiation dose responses for chemoradiation therapy of pancreatic cancer: an analysis of compiled clinical data using biophysical models.

    Science.gov (United States)

    Moraru, Ion C; Tai, An; Erickson, Beth; Li, X Allen

    2014-01-01

    We analyzed recent clinical data obtained from chemoradiation of unresectable, locally advanced pancreatic cancer (LAPC) in order to examine possible benefits from radiation therapy dose escalation. A modified linear quadratic model was used to fit clinical tumor response and survival data of chemoradiation treatments for LAPC reported from 20 institutions. Biophysical radiosensitivity parameters were extracted from the fits. Examination of the clinical data demonstrated an enhancement in tumor response with higher irradiation dose, an important clinical result for palliation and quality of life. Little indication of improvement in 1-year survival with increased radiation dose was observed. Possible dose escalation schemes are proposed based on calculations of the biologically effective dose required for a 50% tumor response rate. Based on the evaluation of tumor response data, the escalation of radiation dose presents potential clinical benefits which when combined with normal tissue complication analyses may result in improved treatment outcome for locally advanced pancreatic cancer patients. Copyright © 2014 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

  17. Integrating Education: Parekhian Multiculturalism and Good Practice

    Science.gov (United States)

    McGlynn, Claire

    2009-01-01

    This paper explores the concept of good practice in integrating education in divided societies. Using Northern Ireland as a case study, the paper draws on data from eight schools (both integrated Catholic and Protestant, and separate) that are identified as exemplifying good practice in response to cultural diversity. Analysis is provided through…

  18. Serial diffusion-weighted MRI correlates with clinical course and treatment response in children with intracranial pus collections

    International Nuclear Information System (INIS)

    Fanning, Noel F.; Laffan, Eoghan E.; Shroff, Manohar M.

    2006-01-01

    Accurate assessment of treatment response in children with intracranial pus collections is vital to guide appropriate therapy and reduce morbidity and mortality. To correlate serial MR-measurable changes in diffusion-weighted imaging (DWI) with clinical response to treatment. We retrospectively reviewed clinical notes, conventional MR sequences and DWI in eight children with intracranial pus collections. Trace DWI signal intensity and apparent diffusion coefficient (ADC) values were compared at three time points: at initial diagnosis (eight children, 13 collections), at follow-up during continued clinical infection (three children, sp collections), and at follow-up when clinical infection had resolved (seven children, 12 collections). At initial diagnosis all patients were septic and collections showed restricted diffusion (mean ADC 0.61±0.15 x 10 -3 mm 2 /s). Patients with persistent clinical sepsis at follow-up DWI had collections with persistent low ADC values (0.66±0.21 x 10 -3 mm 2 /s), significantly (P -3 mm 2 /s, P<0.01) compared both to patients with signs of continued sepsis and to normal gray matter values. Persistent restricted diffusion in pus collections correlates with continued sepsis. Treatment response is associated with clinical resolution of sepsis and ADC value elevation significantly above normal gray matter values. (orig.)

  19. Clinical trials using IFN-α as a vaccine adjuvant: new strategies for the molecular monitoring of the immune response

    International Nuclear Information System (INIS)

    Belardelli, F.; Arico, E.; Marincola, F.; Wang, E.

    2009-01-01

    The main general objective of this project was to define immunotherapy protocols based on the new concept of using IFN-a as and immune adjuvant, developing innovative methodologies suitable for predicting and monitoring the immunological and clinical responses. Specific aim of developing new micro arrays technologies particularly suitable for a molecular tracking and prediction of the response to IFN of cytokine-treated patients

  20. Luggage and shipped goods

    International Nuclear Information System (INIS)

    Vogel, H.; Haller, D.

    2007-01-01

    Summary: Purpose: Control of luggage and shipped goods are frequently carried out. The possibilities of X-ray technology shall be demonstrated. Materials and methods: There are different imaging techniques. The main concepts are transmission imaging, backscatter imaging, computed tomography, and dual energy imaging and the combination of different methods The images come from manufacturers and personal collections. Results: The search concerns mainly, weapons, explosives, and drugs; furthermore animals, and stolen goods, Special problems offer the control of letters and the detection of Improvised Explosive Devices (IED). Conclusion: One has to expect that controls will increase and that imaging with X-rays will have their part. Pattern recognition software will be used for analysis enforced by economy and by demand for higher efficiency - man and computer will produce more security than man alone

  1. Meet the good child

    DEFF Research Database (Denmark)

    Gram, Malene; Grønhøj, Alice

    2016-01-01

    This article explores ‘childing’ pratices in relation to family supermarket shopping in Denmark. ‘Parenting’ practices have been explored for long but little attention has been given to how children strive to be ‘good’ children, who live up to certain standards and recognize what they perceive...... to be appropriate child and parental behavior. The study takes a practice theoretical perspective, building on previous research on family consumption, and draws empirically on 35 interviews with 5–6 year-olds and 13 family interviews. Findings show that the children recognize the position of ‘the good child......’ and most often prefer to take on this position, which is confirmed by their parents. The children can describe how ‘the good child’—in their eyes—should behave. They prefer consensus and not being embarrassing or embarrassed. The study concludes that the children are strongly immersed in social norms...

  2. Neuroinflammatory responses to traumatic brain injury: etiology, clinical consequences, and therapeutic opportunities

    Directory of Open Access Journals (Sweden)

    Lozano D

    2015-01-01

    Full Text Available Diego Lozano,* Gabriel S Gonzales-Portillo,* Sandra Acosta, Ike de la Pena, Naoki Tajiri, Yuji Kaneko, Cesar V Borlongan Department of Neurosurgery and Brain Repair, University of South Florida Morsani College of Medicine, Tampa, FL, USA *These authors contributed equally to this work Abstract: Traumatic brain injury (TBI is a serious public health problem accounting for 1.4 million emergency room visits by US citizens each year. Although TBI has been traditionally considered an acute injury, chronic symptoms reminiscent of neurodegenerative disorders have now been recognized. These progressive neurodegenerative-like symptoms manifest as impaired motor and cognitive skills, as well as stress, anxiety, and mood affective behavioral alterations. TBI, characterized by external bumps or blows to the head exceeding the brain’s protective capacity, causes physical damage to the central nervous system with accompanying neurological dysfunctions. The primary impact results in direct neural cell loss predominantly exhibiting necrotic death, which is then followed by a wave of secondary injury cascades including excitotoxicity, oxidative stress, mitochondrial dysfunction, blood–brain barrier disruption, and inflammation. All these processes exacerbate the damage, worsen the clinical outcomes, and persist as an evolving pathological hallmark of what we now describe as chronic TBI. Neuroinflammation in the acute stage of TBI mobilizes immune cells, astrocytes, cytokines, and chemokines toward the site of injury to mount an antiinflammatory response against brain damage; however, in the chronic stage, excess activation of these inflammatory elements contributes to an “inflamed” brain microenvironment that principally contributes to secondary cell death in TBI. Modulating these inflammatory cells by changing their phenotype from proinflammatory to antiinflammatory would likely promote therapeutic effects on TBI. Because neuroinflammation occurs at

  3. Trees are good, but…

    Science.gov (United States)

    E.G. McPherson; F. Ferrini

    2010-01-01

    We know that “trees are good,” and most people believe this to be true. But if this is so, why are so many trees neglected, and so many tree wells empty? An individual’s attitude toward trees may result from their firsthand encounters with specific trees. Understanding how attitudes about trees are shaped, particularly aversion to trees, is critical to the business of...

  4. Codes of Good Governance

    DEFF Research Database (Denmark)

    Beck Jørgensen, Torben; Sørensen, Ditte-Lene

    2013-01-01

    Good governance is a broad concept used by many international organizations to spell out how states or countries should be governed. Definitions vary, but there is a clear core of common public values, such as transparency, accountability, effectiveness, and the rule of law. It is quite likely......, transparency, neutrality, impartiality, effectiveness, accountability, and legality. The normative context of public administration, as expressed in codes, seems to ignore the New Public Management and Reinventing Government reform movements....

  5. Everybody needs good neighbours

    Energy Technology Data Exchange (ETDEWEB)

    Hoffman, G. [Peabody Energy (United States)

    2006-05-15

    The paper outlines the possibilities for mines to work with surrounding communities to bring about effective land reclamation. Last year Peabody Energy teams reclaimed more than 5000 acres of land and planted nearly 750,000 trees, demonstrating that sustainable development is possible in a way that is compatible with environmental improvement in coal mining. The company has won over 20 awards over the last two years. The North Antelope Rochelle Mine in Wyoming earned a Gold Good Neighbour Award for promoting best practices in environmental conservation and mining education. The Black Mesa and Kayenta mines, which operate on Navajo and Hopi lands in Arizona, were honoured with a Silver Good Neighbour Award and a National Excellence in Mining and Reclamation Award. These mines partnered with the tribes, the Bureau of Indian Affairs and local residents to give residents access to grazing land still under Peabody's control. The Farmersburg Mine in Indiana received the Bronze Good Neighbour Award for commitment to industry education and outreach activities. 5 photos.

  6. Evaluation of prescriber responses to pharmacogenomics clinical decision support for thiopurine S-methyltransferase testing.

    Science.gov (United States)

    Ubanyionwu, Samuel; Formea, Christine M; Anderson, Benjamin; Wix, Kelly; Dierkhising, Ross; Caraballo, Pedro J

    2018-02-15

    Results of a study of prescribers' responses to a pharmacogenomics-based clinical decision support (CDS) alert designed to prompt thiopurine S -methyltransferase (TPMT) status testing are reported. A single-center, retrospective, chart review-based study was conducted to evaluate prescriber compliance with a pretest CDS alert that warned of potential thiopurine drug toxicity resulting from deficient TPMT activity due to TPMT gene polymorphism. The CDS alert was triggered when prescribers ordered thiopurine drugs for patients whose records did not indicate TPMT status or when historical thiopurine use was documented in the electronic health record. The alert pop-up also provided a link to online educational resources to guide thiopurine dosing calculations. During the 9-month study period, 500 CDS alerts were generated: in 101 cases (20%), TPMT phenotyping or TPMT genotyping was ordered; in 399 cases (80%), testing was not ordered. Multivariable regression analysis indicated that documentation of historical thiopurine use was the only independent predictor of test ordering. Among the 99 patients tested subsequent to CDS alerts, 70 (71%) had normal TPMT activity, 29 (29%) had intermediate activity, and none had deficient activity. The online resources provided thiopurine dosing recommendations applicable to 24 patients, but only 3 were prescribed guideline-supported doses after CDS alerts. The pretest CDS rule resulted in a large proportion of neglected alerts due to poor alerting accuracy and consequent alert fatigue. Prescriber usage of online thiopurine dosing resources was low. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  7. The Clinical Response to Gluten Challenge: A Review of the Literature

    Science.gov (United States)

    Bruins, Maaike J.

    2013-01-01

    The aim of this review was to identify, evaluate and summarize all relevant studies reporting on the clinical response to gluten challenge by adult or pediatric patients with suspected or diagnosed coeliac disease (CD) on a gluten-free diet. We evaluated the effect of gluten challenge on changes in symptoms, intestinal mucosa histology, and serum antibodies. A systematic electronic search was performed for studies published as of 1966 using PubMed and Scopus databases. In the reviewed studies, doses ranged from 0.2 to 30 g/day of wheat gluten or comprised a gluten-containing diet. The onset of symptoms upon gluten intake varied largely from days to months and did not parallel serum antibody or histological changes. Within 3 months of gluten challenge, 70%–100% of pediatric CD patients became positive for AGA-IgA and EMA-IgA antibodies and 50%–70% for AGA-IgG. A limited number of trials suggest that no more than half of adult patients developed positive AGA-IgA, EMA-IgA, tTG-IgA or DGP-IgA/IgG titers. Approximately 50%–100% of pediatric and adult patients experienced mucosal relapse of gluten provocation within 3 months, which was preceded by increased mucosal intra-epithelial lymphocytes within several days of challenge. A 3-month high-dose gluten challenge should be suitable to diagnose the majority of CD patients. In some cases prolonged challenge may be needed to verify diagnosis. Combination testing for antibodies and mucosal histology may fasten the diagnosis. PMID:24284613

  8. Predictive event modelling in multicenter clinical trials with waiting time to response.

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

    A new analytic statistical technique for predictive event modeling in ongoing multicenter clinical trials with waiting time to response is developed. It allows for the predictive mean and predictive bounds for the number of events to be constructed over time, accounting for the newly recruited patients and patients already at risk in the trial, and for different recruitment scenarios. For modeling patient recruitment, an advanced Poisson-gamma model is used, which accounts for the variation in recruitment over time, the variation in recruitment rates between different centers and the opening or closing of some centers in the future. A few models for event appearance allowing for 'recurrence', 'death' and 'lost-to-follow-up' events and using finite Markov chains in continuous time are considered. To predict the number of future events over time for an ongoing trial at some interim time, the parameters of the recruitment and event models are estimated using current data and then the predictive recruitment rates in each center are adjusted using individual data and Bayesian re-estimation. For a typical scenario (continue to recruit during some time interval, then stop recruitment and wait until a particular number of events happens), the closed-form expressions for the predictive mean and predictive bounds of the number of events at any future time point are derived under the assumptions of Markovian behavior of the event progression. The technique is efficiently applied to modeling different scenarios for some ongoing oncology trials. Case studies are considered. Copyright © 2011 John Wiley & Sons, Ltd.

  9. The Clinical Response to Gluten Challenge: A Review of the Literature

    Directory of Open Access Journals (Sweden)

    Maaike J. Bruins

    2013-11-01

    Full Text Available The aim of this review was to identify, evaluate and summarize all relevant studies reporting on the clinical response to gluten challenge by adult or pediatric patients with suspected or diagnosed coeliac disease (CD on a gluten-free diet. We evaluated the effect of gluten challenge on changes in symptoms, intestinal mucosa histology, and serum antibodies. A systematic electronic search was performed for studies published as of 1966 using PubMed and Scopus databases. In the reviewed studies, doses ranged from 0.2 to 30 g/day of wheat gluten or comprised a gluten-containing diet. The onset of symptoms upon gluten intake varied largely from days to months and did not parallel serum antibody or histological changes. Within 3 months of gluten challenge, 70%–100% of pediatric CD patients became positive for AGA-IgA and EMA-IgA antibodies and 50%–70% for AGA-IgG. A limited number of trials suggest that no more than half of adult patients developed positive AGA-IgA, EMA-IgA, tTG-IgA or DGP-IgA/IgG titers. Approximately 50%–100% of pediatric and adult patients experienced mucosal relapse of gluten provocation within 3 months, which was preceded by increased mucosal intra-epithelial lymphocytes within several days of challenge. A 3-month high-dose gluten challenge should be suitable to diagnose the majority of CD patients. In some cases prolonged challenge may be needed to verify diagnosis. Combination testing for antibodies and mucosal histology may fasten the diagnosis.

  10. Kinetics of circulating antibody response to Trichomonas vaginalis: clinical and diagnostic implications.

    Science.gov (United States)

    Ton Nu, Phuong Anh; Rappelli, Paola; Dessì, Daniele; Nguyen, Vu Quoc Huy; Fiori, Pier Luigi

    2015-12-01

    Persistence of antibodies against pathogens after antimicrobial treatment is a marker of therapy failure or evolution to a chronic infection. The kinetics of antibody production decrease following antigen elimination is highly variable, and predicting the duration of soluble immunity in infectious diseases is often impossible. This hampers the development and use of immunoassays for diagnostic and seroepidemiological purposes. In the case of Trichomonas vaginalis infection, the kinetics of antibody levels decrease following therapy has never been studied. We thus investigated the clearance of circulating anti-T. vaginalis IgGs after pharmacological treatment in patients affected by trichomoniasis. 18 female patients affected by acute trichomoniasis were enrolled in this study. After metronidazole therapy administration, subjects were followed up monthly up to 5 months, and serum levels of anti-T. vaginalis IgGs were measured by ELISA. We showed that a successful therapy is characterised by a relatively fast decline of specific antibodies, until turning into negative by ELISA in 1-3 months. In a few patients we observed that the persistence of anti-T. vaginalis antibodies was associated with an evolution to chronic infection, which may be due to treatment failure or to reinfection by untreated sexual partners. Our results describe the direct correlation between the decline of a specific humoral anti-T. vaginalis response and an effective antimicrobial therapy. These findings may facilitate the follow-up approach to circumvent limitations in developing new diagnostic tools and techniques routinely used in microbiology laboratories to assess the presence of T. vaginalis in clinical samples. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  11. Clinical responses to ERK inhibition in BRAFV600E-mutant colorectal cancer predicted using a computational model.

    Science.gov (United States)

    Kirouac, Daniel C; Schaefer, Gabriele; Chan, Jocelyn; Merchant, Mark; Orr, Christine; Huang, Shih-Min A; Moffat, John; Liu, Lichuan; Gadkar, Kapil; Ramanujan, Saroja

    2017-01-01

    Approximately 10% of colorectal cancers harbor BRAF V600E mutations, which constitutively activate the MAPK signaling pathway. We sought to determine whether ERK inhibitor (GDC-0994)-containing regimens may be of clinical benefit to these patients based on data from in vitro (cell line) and in vivo (cell- and patient-derived xenograft) studies of cetuximab (EGFR), vemurafenib (BRAF), cobimetinib (MEK), and GDC-0994 (ERK) combinations. Preclinical data was used to develop a mechanism-based computational model linking cell surface receptor (EGFR) activation, the MAPK signaling pathway, and tumor growth. Clinical predictions of anti-tumor activity were enabled by the use of tumor response data from three Phase 1 clinical trials testing combinations of EGFR, BRAF, and MEK inhibitors. Simulated responses to GDC-0994 monotherapy (overall response rate = 17%) accurately predicted results from a Phase 1 clinical trial regarding the number of responding patients (2/18) and the distribution of tumor size changes ("waterfall plot"). Prospective simulations were then used to evaluate potential drug combinations and predictive biomarkers for increasing responsiveness to MEK/ERK inhibitors in these patients.

  12. Clinical, immunological and virological response to different antiretroviral regimens in a cohort of HIV-2-infected patients

    NARCIS (Netherlands)

    van der Ende, Marchina E.; Prins, Jan M.; Brinkman, Kees; Keuter, Monique; Veenstra, Jan; Danner, Sven A.; Niesters, Hubert G. M.; Osterhaus, Albert D. M. E.; Schutten, Martin

    2003-01-01

    Objective: To assess the clinical, immunological and virological response and the emergence of resistance towards antiretroviral therapy (ART) in a cohort of HIV-2-infected patients. Design: Observational study. Patients: HIV-2-infected patients residing in the Netherlands. Results: From 1995 to

  13. Partial response to biotin therapy in a patient with holocarboxylase synthetase deficiency: clinical, biochemical, and molecular genetic aspects

    NARCIS (Netherlands)

    Santer, R.; Muhle, H.; Suormala, T.; Baumgartner, E. R.; Duran, M.; Yang, X.; Aoki, Y.; Suzuki, Y.; Stephani, U.

    2003-01-01

    We report the clinical course and biochemical findings of a 10-year-old, mentally retarded girl with late-onset holocarboxylase synthetase (HCS, gene symbol HLCS) deficiency and only partial response to biotin. On treatment, even with an unusually high dose of 200mg/day, activities of the

  14. From the Consulting Room to the Court Room? Taking the Clinical Model of Responsibility Without Blame into the Legal Realm.

    Science.gov (United States)

    Lacey, Nicola; Pickard, Hanna

    2013-03-01

    Within contemporary penal philosophy, the view that punishment can only be justified if the offender is a moral agent who is responsible and hence blameworthy for their offence is one of the few areas on which a consensus prevails. In recent literature, this precept is associated with the retributive tradition, in the modern form of 'just deserts'. Turning its back on the rehabilitative ideal, this tradition forges a strong association between the justification of punishment, the attribution of responsible agency in relation to the offence, and the appropriateness of blame. By contrast, effective clinical treatment of disorders of agency employs a conceptual framework in which ideas of responsibility and blameworthiness are clearly separated from what we call 'affective blame': the range of hostile, negative attitudes and emotions that are typical human responses to criminal or immoral conduct. We argue that taking this clinical model of 'responsibility without blame' into the legal realm offers new possibilities. Theoretically, it allows for the reconciliation of the idea of 'just deserts' with a rehabilitative ideal in penal philosophy. Punishment can be reconceived as consequences-typically negative but occasionally not, so long as they are serious and appropriate to the crime and the context-imposed in response to, by reason of, and in proportion to responsibility and blameworthiness, but without the hard treatment and stigma typical of affective blame. Practically, it suggests how sentencing and punishment can better avoid affective blame and instead further rehabilitative and related ends, while yet serving the demands of justice.

  15. Treatment failure in patients with HPV 16-induced vulvar intraepithelial neoplasia: understanding different clinical responses to immunotherapy.

    Science.gov (United States)

    van Esch, Edith M G; Welters, Marij J P; Jordanova, Ekaterina S; Trimbos, J Baptist M Z; van der Burg, Sjoerd H; van Poelgeest, Mariëtte I E

    2012-07-01

    Failure of the immune system to launch a strong and effective immune response to high-risk HPV is related to viral persistence and the development of anogenital (pre)malignant lesions such as vulvar intraepithelial neoplasia (VIN). Different forms of immunotherapy, aimed at overcoming the inertia of the immune system, have been developed and met with clinical success. Unfortunately these, in principal successful, therapeutic approaches also fail to induce clinical responses in a substantial number of cases. In this review, the authors summarize the traits of the immune response to HPV in healthy individuals and in patients with HPV-induced neoplasia. The potential mechanisms involved in the escape of HPV-induced lesions from the immune system indicate gaps in our knowledge. Finally, the interaction between the immune system and VIN is discussed with a special focus on the different forms of immunotherapy applied to treat VIN and the potential causes of therapy failure. The authors conclude that there are a number of pre-existing conditions that determine the patients' responsiveness to immunotherapy. An immunotherapeutic strategy in which different aspects of immune failure are attacked by complementary approaches, will improve the clinical response rate.

  16. Nuclear waste: good news

    International Nuclear Information System (INIS)

    Gay, Michel

    2014-01-01

    The author states that the problem of nuclear wastes is solved. He states that 90 per cent of radioactive wastes are now permanently managed and that technical solutions for deep geological storage and for transmutation will soon solve the problem for the remaining 10 pc. He states that geological storage will be funded (it is included in electricity price). He denounces why these facts which he consider as good news, do not prevail. He proposes several documents in appendix: a text explaining the nuclear fuel cycle in France, and an extract of a report made by the national inventory of radioactive materials and wastes

  17. Good manufacturing practice

    International Nuclear Information System (INIS)

    Schlyer, D.J.

    2001-01-01

    In this presentation author deals with the Implementation of good manufacturing practice for radiopharmaceuticals. The presentation is divided into next parts: Batch size; Expiration date; QC Testing; Environmental concerns; Personnel aspects; Radiation concerns; Theoretical yields; Sterilizing filters; Control and reconciliation of materials and components; Product strength; In process sampling and testing; Holding and distribution; Drug product inspection; Buildings and facilities; Renovations at BNL for GMP; Aseptic processing and sterility assurance; Process validation and control; Quality control and drug product stability; Documentation and other GMP topics; Building design considerations; Equipment; and Summary

  18. PHP The Good Parts

    CERN Document Server

    MacIntyre, Peter

    2010-01-01

    Get past all the hype about PHP and dig into the real power of this language. This book explores the most useful features of PHP and how they can speed up the web development process, and explains why the most commonly used PHP elements are often misused or misapplied. You'll learn which parts add strength to object-oriented programming, and how to use certain features to integrate your application with databases. Written by a longtime member of the PHP community, PHP: The Good Parts is ideal for new PHP programmers, as well as web developers switching from other languages. Become familiar w

  19. Good supervision and PBL

    DEFF Research Database (Denmark)

    Otrel-Cass, Kathrin

    This field study was conducted at the Faculty of Social Sciences at Aalborg University with the intention to investigate how students reflect on their experiences with supervision in a PBL environment. The overall aim of this study was to inform about the continued work in strengthening supervision...... at this faculty. This particular study invited Master level students to discuss: • How a typical supervision process proceeds • How they experienced and what they expected of PBL in the supervision process • What makes a good supervision process...

  20. The Good Investment.

    Science.gov (United States)

    Prescott, John E; Fresne, Julie A; Youngclaus, James A

    2017-07-01

    The authors reflect on the article in this issue entitled "Borrow or Serve? An Economic Analysis of Options for Financing a Medical School Education" by Marcu and colleagues, which makes a compelling case that a medical school education is a good investment, no matter what financing option students use, from federal service programs to federal loans. The lead author of this Commentary shares lessons learned from his own medical school education, which was funded by an Armed Forces Health Professions Scholarship, and from his current position interacting with medical students across the United States.Regardless of the financing path they choose, all students should understand basic financial concepts and the details of the various pathways that are available to pay for their medical school education, as well as how each could potentially impact their own future and that of their families. One underappreciated aspect of financing a medical school education is that federal repayment scenarios can link loan payments to income, rather than debt levels, which means that all physicians are able to afford their loan payments no matter what specialty they practice, what they are paid, or where they live.Medical education, while expensive, remains the good investment. An MD degree can lead to a lifetime of personal fulfillment and societal contributions. Everyone, with rare exceptions, accepted to a U.S. medical school will be able to finance their medical education via a path that aligns with their personal values and priorities.

  1. 'Good Governance' dan 'Governability'

    Directory of Open Access Journals (Sweden)

    - Pratikno

    2005-03-01

    Full Text Available The article endeavors to trace the outset of governance concept, its dominant meanings and discourse, and its implication towards governability. The central role of government in the governing processes has predominantly been adopted. The concept of governance was emerged precisely in the context of the failure of government as key player in regulation, economic redistribution and political participation. Governance is therefore aimed to emphasize pattern of governing which are based both on democratic mechanism and sound development management. However, practices of such good governance concept –which are mainly adopted and promoted by donor states and agencies– tend to degrade state and/or government authority and legitimacy. Traditional function of the state as sole facilitator of equal societal, political and legal membership among citizens has been diminished. The logic of fair competition has been substituted almost completely by the logic of free competition in nearly all sectors of public life. The concept and practices of good governance have resulted in decayed state authority and failed state which in turn created a condition for "ungovernability". By promoting democratic and humane governance, the article accordingly encourages discourse to reinstall and bring the idea of accountable state back in.

  2. [Radiation-induced bystander effect: the important part of ionizing radiation response. Potential clinical implications].

    Science.gov (United States)

    Wideł, Maria; Przybyszewski, Waldemar; Rzeszowska-Wolny, Joanna

    2009-08-18

    It has long been a central radiobiological dogma that the damaging effects of ionizing radiation, such as cell death, cytogenetic changes, apoptosis, mutagenesis, and carcinogenesis, are the results of the direct ionization of cell structures, particularly DNA, or indirect damage via water radiolysis products. However, several years ago attention turned to a third mechanism of radiation, termed the "bystander effect" or "radiation-induced bystander effect" (RIBE). This is induced by agents and signals emitted by directly irradiated cells and manifests as a lowering of survival, cytogenetic damage, apoptosis enhancement, and biochemical changes in neighboring non-irradiated cells. The bystander effect is mainly observed in in vitro experiments using very low doses of alpha particles (range; mGy, cGy), but also after conventional irradiation (X-rays, gamma rays) at low as well as conventional doses. The mechanisms responsible for the bystander effect are complex and still poorly understood. It is believed that molecular signals released from irradiated cells induce different signaling ways in non-irradiated neighboring cells, leading to the observed events. The molecular signals may be transmitted through gap junction intercellular communication and through a medium transfer mechanism. The nature of these transmitted factors are diverse, and still not definitely established. It seems that RIBE may have important clinical implications for health risk associated with radiation exposure. Potentially, this effect may have important implications in the creation of whole-body or localized side effects in tissues beyond the irradiation field and also in low-dose radiological and radioisotope diagnostics. Factors emitted by irradiated cells may result in the risk of genetic instability, mutations, and second primary cancer induction. They might also have their own part in inducing and extending post-radiation side effects in normal tissue. The bystander effect may be a

  3. Radiation-induced bystander effect: The important part of ionizing radiation response. Potential clinical implications

    Directory of Open Access Journals (Sweden)

    Maria Wideł

    2009-08-01

    Full Text Available It has long been a central radiobiological dogma that the damaging effects of ionizing radiation, such as cell death, cytogenetic changes, apoptosis, mutagenesis, and carcinogenesis, are the results of the direct ionization of cell structures, particularly DNA, or indirect damage via water radiolysis products. However, several years ago attention turned to a third mechanism of radiation, termed the “bystander effect” or “radiation-induced bystander effect” (RIBE. This is induced by agents and signals emitted by directly irradiated cells and manifests as a lowering of survival, cytogenetic damage, apoptosis enhancement, and biochemical changes in neighboring non-irradiated cells. The bystander effect is mainly observed in in vitro experiments using very low doses of alpha particles (range; mGy, cGy, but also after conventional irradiation (X-rays, gamma rays at low as well as conventional doses. The mechanisms responsible for the bystander effect are complex and still poorly understood. It is believed that molecular signals released from irradiated cells induce different signaling ways in non-irradiated neighboring cells, leading to the observed events. The molecular signals may be transmitted through gap junction intercellular communication and through a medium transfer mechanism. The nature of these transmitted factors are diverse, and still not defi nitely established. It seems that RIBE may have important clinical implications for health risk associated with radiation exposure. Potentially, this effectmay have important implications in the creation of whole-body or localized side effects in tissues beyond the irradiation fi eld and also in low-dose radiological and radioisotope diagnostics. Factors emitted by irradiated cells may result in the risk of genetic instability, mutations, and second primary cancer induction. They might also have their own part in inducing and extending post-radiation side effects in normal tissue. The

  4. Cranial nerve involvement in nasopharyngeal carcinoma: response to radiotherapy and its clinical impact.

    Science.gov (United States)

    Li, Jian-Cheng; Mayr, Nina A; Yuh, William T C; Wang, Jian Z; Jiang, Guo-Liang

    2006-05-01

    To evaluate the cranial nerve (CN) palsy associated with nasopharyngeal carcinoma (NPC), we studied factors that influenced the neurologic outcome of radiotherapy (RT), and the patterns and time course of neurologic recovery of CN palsy. Between July 1987 and July 1989, 93 patients who presented with CN palsy at the time of diagnosis of NPC were studied. All patients underwent external-beam RT with either cobalt-60 or 6-MV photon beams to a dose of 69 to 84 Gy at 2 Gy per fraction. The time course and pattern of neurologic recovery (complete, partial, or none) from CN palsy were evaluated. Age, sex, stage, histology, incidence and distribution of types of CNs involved, duration of CN palsy, and time course of tumor response during RT were correlated with the patterns and the time course of neurologic CN recovery by univariate and multivariate analyses. The cases of CN palsy most commonly involved CN V (38%), CN VI (26%), and CN XII (11%), which accounted for the majority of the cases (75%). The time course of CN recovery was variable and protracted. Most patients showed significant improvement upon completion of RT (51%, 19%, and 30% complete, partial, and no recovery, respectively) and further improvement 6 months after RT (58%, 17%, and 25%, respectively). Cranial nerves V, VI, and XII accounted for 75% of cases with no recovery. Recovery was best for CNs II, IX, and XI and the sympathetic nerve (100%, 87%, 100%, and 100%, respectively) and worst for CNs IV, VII, and XII (67%, 60%, and 40%, respectively, with no recovery). Neurologic CN recovery correlated significantly with the pretherapy duration ( or =3 months) of CN palsy (88% versus 62%; p = .002, multivariate analysis), the time course of clinical tumor regression, and neurologic symptom improvement during RT. Age, sex, T stage, N stage, histology, anterior versus posterior CN palsies, and base of skull involvement were not significant. According to our limited data, most patients with CN palsy respond well

  5. A systematic review on the effect of sweeteners on glycemic response and clinically relevant outcomes

    Directory of Open Access Journals (Sweden)

    Wiebe Natasha

    2011-11-01

    Full Text Available Abstract Background The major metabolic complications of obesity and type 2 diabetes may be prevented and managed with dietary modification. The use of sweeteners that provide little or no calories may help to achieve this objective. Methods We did a systematic review and network meta-analysis of the comparative effectiveness of sweetener additives using Bayesian techniques. MEDLINE, EMBASE, CENTRAL and CAB Global were searched to January 2011. Randomized trials comparing sweeteners in obese, diabetic, and healthy populations were selected. Outcomes of interest included weight change, energy intake, lipids, glycated hemoglobin, markers of insulin resistance and glycemic response. Evidence-based items potentially indicating risk of bias were assessed. Results Of 3,666 citations, we identified 53 eligible randomized controlled trials with 1,126 participants. In diabetic participants, fructose reduced 2-hour blood glucose concentrations by 4.81 mmol/L (95% CI 3.29, 6.34 compared to glucose. Two-hour blood glucose concentration data comparing hypocaloric sweeteners to sucrose or high fructose corn syrup were inconclusive. Based on two ≤10-week trials, we found that non-caloric sweeteners reduced energy intake compared to the sucrose groups by approximately 250-500 kcal/day (95% CI 153, 806. One trial found that participants in the non-caloric sweetener group had a decrease in body mass index compared to an increase in body mass index in the sucrose group (-0.40 vs 0.50 kg/m2, and -1.00 vs 1.60 kg/m2, respectively. No randomized controlled trials showed that high fructose corn syrup or fructose increased levels of cholesterol relative to other sweeteners. Conclusions Considering the public health importance of obesity and its consequences; the clearly relevant role of diet in the pathogenesis and maintenance of obesity; and the billions of dollars spent on non-caloric sweeteners, little high-quality clinical research has been done. Studies are

  6. Is response-guided therapy being applied in the clinical setting? The hepatitis C example.

    Science.gov (United States)

    Harris, Jennifer B; Ward, Melea A; Schwab, Phil

    2015-02-01

    Response-guided therapy (RGT) is a treatment model that bases adjustments to therapeutic regimens on individualized patient physiologic response. This approach is applied to patients with chronic hepatitis C virus (HCV) infection who are treated with a triple therapy regimen of boceprevir or telaprevir in combination with pegylated interferon and ribavirin. As RGT expands in other pharmacologic regimens, including the treatment of breast cancer and acute myeloid leukemia, a measurement of how this approach is applied in clinical practice is important to determine whether the benefits of RGT are being optimized. To measure adherence to the RGT guidelines and to the treatment futility rules based on the drug labeling information for boceprevir and for telaprevir in the treatment of patients with chronic HCV infection. A retrospective observational cohort study was conducted using the large Humana research database, which includes pharmacy, medical, and laboratory claims, as well as enrollment data for more than 1.5 million fully insured commercial members, 1.9 million Medicare Advantage members, and 2.4 million Medicare Part D members from all 50 states. The study population included patients aged ≥18 years to <90 years who were fully insured with commercial or Medicare Advantage coverage. A pharmacy claim for boceprevir or telaprevir was used to identify patients receiving triple therapy for HCV infection. Medical, pharmacy, and laboratory claims were reviewed from the date of the first boceprevir or telaprevir pharmacy claim between May 2011 and February 2012 through a 32-week follow-up period, during which patients were required to have continuous health plan enrollment eligibility. This time period allowed for the occurrences of required HCV RNA laboratory monitoring and the assessment of treatment patterns. The use of RGT for boceprevir and telaprevir includes the monitoring of HCV RNA levels at routine intervals to determine how to proceed with therapy

  7. Effect of nonsurgical periodontal treatment on clinical response and glycemic control in type 2 diabetic patients with periodontitis: Controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ajitha Kanduluru

    2014-01-01

    Full Text Available Background: Type 2 diabetes mellitus (type 2 DM and chronic periodontitis are common chronic diseases in adults in the world population. Once periodontal disease is established, the chronic nature of this infection may contribute to worsening of diabetic status leading to more severe diabetes-related complications. It has been proposed that the relation of periodontitis and diabetes is bidirectional. Objectives: The objective was to compare the clinical response and glycemic control in type 2 DM patients with periodontitis, before and after the nonsurgical periodontal treatment with controls. Materials and Methods: A total 70 type 2 DM patients with chronic generalized moderate periodontitis was divided into 2 groups. Treatment group (35 received one stage full mouth scaling and root planning plus oral hygiene instructions; the control group (35 received only oral hygiene instructions. At baseline, 1 st month and 3 rd month, the clinical periodontal parameters (plaque index [PI], gingival index [GI], pocket depth [PD], clinical attachment loss [CAL], gingival recession [GR], and bleeding on probing [BOP] and glycemic parameters (fasting blood sugar [FBS], and postprandial blood sugar [PPBS] were recorded, whereas the glycated hemoglobin (HbA1c was recorded only at baseline and 3rd month. The collected data were subjected to statistical analysis. Results: When comparing the mean scores of clinical parameters for both the groups, there was a significant difference in all clinical parameters, that is, mean PI, GI, BOP, PD, CAL scores except mean GR, whereas for the glycemic parameters, there was a significant difference in mean FBS; PPBS values and no significant difference in mean percentage of HbA1c for treatment group at 3 rd month follow-up. Conclusion: Findings of the present study showed that nonsurgical periodontal treatment resulted in lower glycemic levels and the reduction of clinical parameters of periodontal infection, confirming the

  8. [Taking personal responsibility in practice: what does it mean?--Insights into daily clinical routines].

    Science.gov (United States)

    Hansen, Leonhard

    2012-01-01

    In our society, taking personal responsibility is basically regarded as a key step to adopting a more active lifestyle. In health care, however, personal responsibility is primarily equated with higher levels of financial contribution from patients. Obviously, the individual's responsibility for his or her health and towards the mutually supportive community is a highly emotional and ideological issue, so the debate is usually rather heated. This is, however, at odds with the "empowered patient" concept. In the present paper "personal responsibility in practice" will be understood to include both physician and patient responsibility. Examples will be employed to demonstrate that, on an individual level, physicians are responsible for diagnosing and treating their patients as indicated and that, on a collective level, they are expected to make responsible use of the resources allocated. Here, patient responsibility will be defined as both taking care for one's own health and the individual's obligation to contribute to the maintenance of our solidarity-based health care system. The tensions between solidarity and subsidiarity and personal responsibility, respectively, will be outlined, and a readjustment of the relation between external support and individual strengths, between solidarity and personal responsibility in terms of Sect. 1 of the Social Book Code V will be advocated. Copyright © 2012. Published by Elsevier GmbH.

  9. [Can tobacco companies be good corporate citizens?].

    Science.gov (United States)

    Palazzo, G; Mena, S

    2009-07-01

    Tobacco companies have jumped on the Corporate social responsibility (CSR) bandwagon as a tentative to be societally accepted as responsible actors and good corporate citizens. This is however not possible for two reasons. First, the product they sell is lethal and thus not compatible with the precondition of doing no harm to be a good corporate citizen. Second, the behavior of tobacco firms is not responsible, being illustrated by four examples: junk science versus sound science strategy, seducing young smokers, political lobbying and getting customers on new markets. To conclude, three implications for regulating the activities of the tobacco industry are given.

  10. Cytokine responses to Staphylococcus aureus bloodstream infection differ between patient cohorts that have different clinical courses of infection.

    Science.gov (United States)

    McNicholas, Sinead; Talento, Alida Fe; O'Gorman, Joanne; Hannan, Margaret M; Lynch, Maureen; Greene, Catherine M; Humphreys, Hilary; Fitzgerald-Hughes, Deirdre

    2014-11-15

    The clinical course of Staphylococcus aureus bloodstream infection is unpredictable and bacterial virulence, host immune response and patient characteristics are among the factors that contribute to the clinical course of infection. To investigate the relationship between cytokine response and clinical outcome, circulating cytokine levels were investigated in response to S. aureus bloodstream infection in patients with different clinical courses of infection. A prospective study was carried out in 61 patients with S. aureus bloodstream infection and circulating levels of IL-6, GRO-γ, RANTES and leptin were assessed over the course of the infection. Levels were compared in patients with complicated courses of infection (e.g. infective endocarditis) versus uncomplicated courses of S. aureus bloodstream infection and methicillin-resistant S. aureus Vs methicillin-susceptible S. aureus infection. Significantly lower leptin levels (p < 0.05) and significantly higher IL-6 levels (p < 0.05) were detected at laboratory diagnosis in patients with complicated compared to uncomplicated S. aureus bloodstream infection. Significantly higher levels of GRO-γ were associated with MRSA infection compared to MSSA infection. IL-6 may be an early inflammatory marker of complicated S. aureus bloodstream infection. Leptin may be protective against the development of a complicated S. aureus bloodstream infection.

  11. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study

    Science.gov (United States)

    Delnoy, Peter Paul; Ritter, Philippe; Naegele, Herbert; Orazi, Serafino; Szwed, Hanna; Zupan, Igor; Goscinska-Bis, Kinga; Anselme, Frederic; Martino, Maria; Padeletti, Luigi

    2013-01-01

    Aims The long-term clinical value of the optimization of atrioventricular (AVD) and interventricular (VVD) delays in cardiac resynchronization therapy (CRT) remains controversial. We studied retrospectively the association between the frequency of AVD and VVD optimization and 1-year clinical outcomes in the 199 CRT patients who completed the Clinical Evaluation on Advanced Resynchronization study. Methods and results From the 199 patients assigned to CRT-pacemaker (CRT-P) (New York Heart Association, NYHA, class III/IV, left ventricular ejection fraction failure-related hospitalization, NYHA functional class, and Quality of Life score, at 1 year. Systematic CRT optimization was associated with a higher percentage of improved patients based on the composite endpoint (85% in Group 1 vs. 61% in Group 2, P < 0.001), with fewer deaths (3% in Group 1 vs. 14% in Group 2, P = 0.014) and fewer hospitalizations (8% in Group 1 vs. 23% in Group 2, P = 0.007), at 1 year. Conclusion These results further suggest that AVD and VVD frequent optimization (at implant, at 3 and 6 months) is associated with improved long-term clinical response in CRT-P patients. PMID:23493410

  12. Good Enough to Teach?

    DEFF Research Database (Denmark)

    Denver, Louise; Jensen, Christian; Mees, Inger

    2016-01-01

    to improve their communicative effectiveness. The feedback was given by experienced tutors of English who had extensive experience of teaching and assessing English in an everyday ELF context. This paper sets out to investigate what sort of recommendations were provided, concentrating on the 24 lecturers...... whose L1 was Danish. An examination of the tutors’ comments showed that they could be divided into two main categories: formal language skills and pragmatic or metadiscursive features. The observations on language features are presented using a slightly adapted version of Lavelle’s (2008) “good......; Jenkins et al. 2011: 301), the analyses of the tutors’ comments to the 24 lecturers in the present study show that both aspects should be attributed importance....

  13. Family Farming Goods Distribution

    Directory of Open Access Journals (Sweden)

    Guilherme Soares Loiola

    2015-11-01

    Full Text Available Farmers need interaction mechanisms closer to customers interested in purchasing their products. The lack of communication between producer and potential buyers impacts on producers financial performance (that could have losses in sales volume, and buyers, which ultimately acquire lower-quality products. Thus, this paper aims to provide a technological solution proposal, the Buscagro: a software application that can be used on mobile devices and towards to enable a better interaction between family farmers and buyers, allowing a greater display of products from the farmer and disclosure of interests of potential buyers. The features of this technology are based on farmers goods data and information products demanded by potential buyers. In this way, the software application performs combinations based on supply and demand data, generating results for producers to have access in how to find buyers and for consumers to find products a greater agility.

  14. Exposure-response relationships in patients with metastatic renal cell carcinoma receiving sunitinib: maintaining optimum efficacy in clinical practice.

    Science.gov (United States)

    Ravaud, Alain; Bello, Carlo L

    2011-06-01

    Targeted agents such as sunitinib, an oral, multitargeted receptor tyrosine kinase inhibitor, have greatly improved the prognosis for patients with metastatic renal cell carcinoma (mRCC). In this review we analyse data from sunitinib preclinical and clinical studies in detail and consider the key implications for the effective use of sunitinib in clinical practice. Sunitinib has shown efficacy and acceptable tolerability in patients with mRCC in phase II and III clinical studies. In a pivotal phase III study in treatment-naïve patients with mRCC, median progression-free survival for sunitinib-treated patients was double of that with interferon-α (P relationship between clinical end points and sunitinib exposure showed that increased sunitinib exposure was associated with a greater probability of objective response, longer time to tumour progression and overall survival, as well as some increased risk of specific adverse events. It is important to consider the relationship between exposure and response to maximize clinical benefit from sunitinib treatment.

  15. Clinical characteristics and long-term response to mood stabilizers in patients with bipolar disorder and different age at onset

    Science.gov (United States)

    Dell’Osso, Bernardo; Buoli, Massimiliano; Riundi, Riccardo; D’Urso, Nazario; Pozzoli, Sara; Bassetti, Roberta; Mundo, Emanuela; Altamura, A Carlo

    2009-01-01

    Introduction Bipolar disorder (BD) is a prevalent, comorbid, and impairing condition. Potential predictors of response to pharmacological treatment are object of continuous investigation in patients with BD. The present naturalistic study was aimed to assess clinical features and long-term response to mood stabilizers in a sample of bipolar subjects with different ages at onset. Methods The study sample included 108 euthymic patients, diagnosed as affected by BD, either type I or II, according to the DSM-IV-TR, who were started on mood stabilizer treatment. Patients were followed-up for 24 months and the occurrence of any mood episode collected. At the end of the follow-up, patients were divided in 3 subgroups according to the age at onset (early-onset ≤30 years, middle-onset >30–≤45 years, and late-onset >45 years, respectively) and the long-term response to mood stabilizers was compared between them along with other clinical features. Results The three subgroups showed significant differences in terms of clinical and demographic features and, with respect to long-term response to mood stabilizers, the early-onset subgroup showed a better outcome in terms of reduction of major depressive episodes during the 24-month follow-up compared to the other subgroups (one way ANOVA, F = 3.57, p = 0.032). Conclusions Even though further controlled studies are needed to clarify the relationship between age at onset and outcome in BD, the present follow-up study suggests clinical peculiarities and different patterns of response to mood stabilizers across distinct subgroups of patients with BD and different ages at onset. PMID:19649214

  16. Acknowledging and allocating responsibility for clinical inertia in the management of Type 2 diabetes in primary care: a qualitative study.

    Science.gov (United States)

    Zafar, A; Stone, M A; Davies, M J; Khunti, K

    2015-03-01

    Failure to intensify treatment in patients with Type 2 diabetes with suboptimal blood glucose control has been termed clinical inertia and has been shown to contribute to poorer patient outcomes. We aimed to identify and explore perceptions about clinical inertia from the perspective of primary healthcare providers. A qualitative study was conducted in Leicestershire and Northamptonshire, UK. Purposive sampling was based on healthcare providers working in primary care settings with 'higher' and 'lower' target achievement based on routine data. Twenty semi-structured interviews were conducted, face-to-face or by telephone. Thematic analysis was informed by the constant comparative approach. An important broad theme that emerged during the analysis was related to attribution and explanation of responsibility for clinical inertia. This included general willingness to accept a degree of responsibility for clinical inertia. In some cases, however, participants had inaccurate perceptions about levels of target achievement in their primary care centres, as indicated by routine data. Participants sought to lessen their own sense of accountability by highlighting patient-level barriers such as comorbidities and human fallibility, and also system-level barriers, particularly time constraints. Perceptions about ways of addressing the problem of clinical inertia were not seen as straightforward, further emphasizing a complex and cumulative pattern of barriers. In order to understand and address the problem of clinical inertia, provider, patient- and system-level barriers should be considered together rather than as separate issues. Acknowledgement of responsibility should be regarded positively as a motivator for change. © 2014 The Authors. Diabetic Medicine © 2014 Diabetes UK.

  17. Cross-sectional survey of Good Samaritan behaviour by physicians in North Carolina

    OpenAIRE

    Garneau, William M; Harris, Dean M; Viera, Anthony J

    2016-01-01

    Objective To assess the responses of physicians to providing emergency medical assistance outside of routine clinical care. We assessed the percentage who reported previous Good Samaritan behaviour, their responses to hypothetical situations, their comfort providing specific interventions and the most likely reason they would not intervene. Setting Physicians residing in North Carolina. Participants Convenience sample of 1000 licensed physicians. Intervention Mailed survey. Design Cross-secti...

  18. Natural history and clinical response: “It’s the virus, stupid, or is it the host?”

    Science.gov (United States)

    2012-01-01

    Summary A major goal of modern medicine is the application of personalized therapies, consisting of decisions and practices tailored to the individual patient. Information about genetic variants, either mutant or polymorphic, represents the basis for the development of this clinical approach. Recently, several independent genome-wide association studies (GWAS) have identified two single nucleotide polymorphisms (SNPs) on the IL28B locus associated with HCV containment, spontaneous clearance, treatment response, and disease progression. In this minireview we will concisely discuss some critical genetic concepts that may have possible implications for clinical decisions in the treatment of HCV infection. PMID:23173731

  19. Clinical responses after total body irradiation by over permissible dose of γ-rays in one time

    International Nuclear Information System (INIS)

    Jiang Benrong; Wang Guilin; Liu Huilan; Tang Xingsheng; Ai Huisheng

    1990-01-01

    The clinical responses of patients after total body over permissilbe dose γ-ray irradiation were observed and analysed. The results showed: when the dose was above 5 cGy, there was some immunological depression, but no significant change in hematopoietic functions. 5 cases showed some transient changes of ECG, perhaps due to vagotonia caused by psychological imbalance, One case vomitted 3-4 times after 28 cGy irradiation, this suggested that a few times of vomitting had no significance in the estimation of the irradiated dose and the whole clinical manifestations must be concretely analysed

  20. Family accommodation of anxiety symptoms in youth undergoing intensive multimodal treatment for anxiety disorders and obsessive-compulsive disorder: Nature, clinical correlates, and treatment response.

    Science.gov (United States)

    La Buissonnière-Ariza, Valérie; Schneider, Sophie C; Højgaard, Davíð; Kay, Brian C; Riemann, Bradley C; Eken, Stephanie C; Lake, Peter; Nadeau, Joshua M; Storch, Eric A

    2018-01-01

    Family accommodation is associated with a range of clinical features including symptom severity, functional impairment, and treatment response. However, most previous studies in children and adolescents investigated family accommodation in samples of youth with obsessive-compulsive disorder (OCD) or anxiety disorders receiving non-intensive outpatient services. In this study, we aimed to investigate family accommodation of anxiety symptoms in a sample of youth with clinical anxiety levels undergoing an intensive multimodal intervention for anxiety disorders or OCD. We first assessed the internal consistency of the Family Accommodation Scale - Anxiety (FASA). We next examined family accommodation presentation and correlates. The FASA showed high internal consistency for all subscales and total score, and good item and subscale correlations with the total score. All parents reported at least mild accommodation, and the mean levels of family accommodation were particularly high. Child age, anxiety severity, and comorbid depressive symptoms predicted baseline accommodation. However, the association between anxiety severity and family accommodation no longer remained significant after adding the other factors to the model. In addition, family accommodation partially mediated the relationship between anxiety severity and functional impairment. Finally, post-treatment changes in family accommodation predicted changes in symptom severity and functional impairment. These findings suggest the FASA is an appropriate tool to assess family accommodation in intensive treatment samples. Further, they underline the importance of addressing family accommodation in this population given the particularly high levels of accommodating behaviors and the evidence for adverse outcomes associated with this feature. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Rapid response predicts 12-month post-treatment outcomes in binge-eating disorder: theoretical and clinical implications

    Science.gov (United States)

    Grilo, C. M.; White, M. A.; Wilson, G. T.; Gueorguieva, R.; Masheb, R. M.

    2011-01-01

    Background We examined rapid response in obese patients with binge-eating disorder (BED) in a clinical trial testing cognitive behavioral therapy (CBT) and behavioral weight loss (BWL). Method Altogether, 90 participants were randomly assigned to CBT or BWL. Assessments were performed at baseline, throughout and post-treatment and at 6- and 12-month follow-ups. Rapid response, defined as ≥70% reduction in binge eating by week four, was determined by receiver operating characteristic curves and used to predict outcomes. Results Rapid response characterized 57% of participants (67% of CBT, 47% of BWL) and was unrelated to most baseline variables. Rapid response predicted greater improvements across outcomes but had different prognostic significance and distinct time courses for CBT versus BWL. Patients receiving CBT did comparably well regardless of rapid response in terms of reduced binge eating and eating disorder psychopathology but did not achieve weight loss. Among patients receiving BWL, those without rapid response failed to improve further. However, those with rapid response were significantly more likely to achieve binge-eating remission (62% v. 13%) and greater reductions in binge-eating frequency, eating disorder psychopathology and weight loss. Conclusions Rapid response to treatment in BED has prognostic significance through 12-month follow-up, provides evidence for treatment specificity and has clinical implications for stepped-care treatment models for BED. Rapid responders who receive BWL benefit in terms of both binge eating and short-term weight loss. Collectively, these findings suggest that BWL might be a candidate for initial intervention in stepped-care models with an evaluation of progress after 1 month to identify non-rapid responders who could be advised to consider a switch to a specialized treatment. PMID:21923964

  2. European Academy of Allergy and Clinical Immunology task force report on 'dose-response relationship in allergen-specific immunotherapy'.

    Science.gov (United States)

    Calderón, M A; Larenas, D; Kleine-Tebbe, J; Jacobsen, L; Passalacqua, G; Eng, P A; Varga, E M; Valovirta, E; Moreno, C; Malling, H J; Alvarez-Cuesta, E; Durham, S; Demoly, P

    2011-10-01

    For a century, allergen-specific immunotherapy (SIT) has proven to be an effective treatment for allergic rhinitis, asthma, and insect sting allergy. However, as allergen doses are frequently adapted to the individual patient, there are few data on dose-response relationship in SIT. Allergen products for SIT are being increasingly required to conform to regulatory requirements for human medicines, which include the need to demonstrate dose-dependent effects. This report, produced by a Task Force of the EAACI Immunotherapy Interest Group, evaluates the currently available data on dose-response relationships in SIT and aims to provide recommendations for the design of future studies. Fifteen dose-ranging studies fulfilled the inclusion criteria and twelve reported a dose-response relationship for clinical efficacy. Several studies also reported a dose-response relationship for immunological and safety endpoints. Due to the use of different reference materials and methodologies for the determination of allergen content, variations in study design, and choice of endpoints, no comparisons could be made between studies and, as a consequence, no general dosing recommendations can be made. Despite recently introduced guidelines on the standardization of allergen preparations and study design, the Task Force identified a need for universally accepted standards for the measurement of allergen content in SIT preparations, dosing protocols, and selection of clinical endpoints to enable dose-response effects to be compared across studies. © 2011 John Wiley & Sons A/S.

  3. Evaluation of the tip-bending response in clinically used endoscopes

    NARCIS (Netherlands)

    Rozeboom, Esther; Reilink, Rob; Schwartz, Matthijs P.; Fockens, Paul; Broeders, Ivo Adriaan Maria Johannes

    Background and study aims: Endoscopic interventions require accurate and precise control of the endoscope tip. The endoscope tip response depends on a cable pulling system, which is known to deliver a significantly nonlinear response that eventually reduces control. It is unknown whether the current

  4. Evaluation of the tip-bending response in clinically used endoscopes

    NARCIS (Netherlands)

    Rozeboom, Esther D.; Reilink, Rob; Schwartz, Matthijs P.; Fockens, Paul; Broeders, Ivo A. M. J.

    2016-01-01

    Background and study aims: Endoscopic interventions require accurate and precise control of the endoscope tip. The endoscope tip response depends on a cable pulling system, which is known to deliver a significantly nonlinear response that eventually reduces control. It is unknown whether the current

  5. Predicting response to epigenetic therapy

    DEFF Research Database (Denmark)

    Treppendahl, Marianne B; Sommer Kristensen, Lasse; Grønbæk, Kirsten

    2014-01-01

    of good pretreatment predictors of response is of great value. Many clinical parameters and molecular targets have been tested in preclinical and clinical studies with varying results, leaving room for optimization. Here we provide an overview of markers that may predict the efficacy of FDA- and EMA...

  6. Volume of the human hippocampus and clinical response following electroconvulsive therapy

    DEFF Research Database (Denmark)

    Oltedal, Leif; Narr, Katherine L.; Abbott, Christopher

    2018-01-01

    Background: Hippocampal enlargements are commonly reported following electroconvulsive therapy (ECT). To clarify mechanisms, we examined if ECT induced hippocampal volume change relates to dose (number of ECT sessions and electrode placement) and acts as a biomarker of clinical outcome. Methods...

  7. Pathologic Response, When Increased by Longer Interval, Is a Marker but Not the Cause of Good Prognosis in Rectal Cancer: 17-year Follow-up of the Lyon R90-01 Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Cotte, Eddy, E-mail: eddy.cotte@chu-lyon.fr [Department of Digestive Surgery, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite (France); Lyon 1 University, EMR 3738, Lyon-Sud/Charles Mérieux Medical University, Oullins (France); Passot, Guillaume [Department of Digestive Surgery, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite (France); Lyon 1 University, EMR 3738, Lyon-Sud/Charles Mérieux Medical University, Oullins (France); Decullier, Evelyne; Maurice, Christelle [Hospices Civils de Lyon, Pôle IMER, Lyon (France); Glehen, Olivier; François, Yves [Department of Digestive Surgery, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite (France); Lyon 1 University, EMR 3738, Lyon-Sud/Charles Mérieux Medical University, Oullins (France); Lorchel, Fabrice; Chapet, Olivier [Department of Radiotherapy, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite (France); Gerard, Jean-Pierre [Department of Radiotherapy, Centre Antoine-Lacassagne, University Nice-Sophia, Nice (France)

    2016-03-01

    Purpose: The Lyon R90-01 randomized trial investigated whether the interval between preoperative radiation therapy and surgery influenced rectal cancer outcome. Long-term results are reported here after a median follow-up of 17 years. Methods and Materials: Between February 1991 and December 1995, 210 patients from 29 French centers were randomly assigned (ratio of 1:1) to groups that waited either 2 weeks (short interval [SI]) or 6 to 8 weeks (long interval [LI]) between neoadjuvant radiation therapy and surgery. The primary endpoint was sphincter-preserving surgery. Results: LI group showed a better pathologic response (complete response or few residual cells) after radiation therapy than the SI group (26% vs 10.3%, P=.015). A better pathologic response was associated in multivariate analysis with significant improvement of overall survival (pT: P=.0293 and pN: P=.0048) but it was irrespective of the interval duration. The median follow-up was 17.2 years. The 5-, 10-, 15-, and 17-year overall survival rates were, respectively, 66.8%, 48.7%, 40.0%, and 34.0% for the SI group and, respectively, 67.1%, 53.5%, 41.9%, and 34.0% for the LI group. There were no significant differences between groups in terms of survival (P=.7656) or local recurrence rates (SI: 14.4% vs LI: 12.1%, respectively; P=.6202). Of 24 local disease recurrences, 20 (83%) occurred during the first 2 postoperative years, and all but one (96%) occurred during the first 5 postoperative years. The rate of second new malignancies was 9.4% (19 patients). Conclusions: The radiation-induced sterilization rate of the preoperative cancer specimen was a marker of good prognosis. The interval duration (the treatment being the same) although it is modifying the sterilization rate has no impact on survival. Radiation therapy did not postpone local recurrence, because the rate of local relapse after 5 years was low. Radiation-induced cancers after radiation therapy were unusual and should not influence

  8. Bread making technology influences postprandial glucose response: a review of the clinical evidence.

    Science.gov (United States)

    Stamataki, Nikoleta S; Yanni, Amalia E; Karathanos, Vaios T

    2017-04-01

    Lowering postprandial glucose and insulin responses may have significant beneficial implications for prevention and treatment of metabolic disorders. Bread is a staple food consumed worldwide in a daily basis, and the use of different baking technologies may modify the glucose and insulin response. The aim of this review was to critically record the human studies examining the application of different bread making processes on postprandial glucose and insulin response to bread. Literature is rich of results which show that the use of sourdough fermentation instead of leavening with Saccharomyces cerevisiae is able to modulate glucose response to bread, whereas evidence regarding its efficacy on lowering postprandial insulin response is less clear. The presence of organic acids is possibly involved, but the exact mechanism of action is still to be confirmed. The reviewed data also revealed that the alteration of other processing conditions (method of cooking, proofing period, partial baking freezing technology) can effectively decrease postprandial glucose response to bread, by influencing physical structure and retrogradation of starch. The development of healthier bread products that benefit postprandial metabolic responses is crucial and suggested baking conditions can be used by the bread industry for the promotion of public health.

  9. ISSLS PRIZE IN CLINICAL SCIENCE 2018: longitudinal analysis of inflammatory, psychological, and sleep-related factors following an acute low back pain episode-the good, the bad, and the ugly.

    Science.gov (United States)

    Klyne, David M; Barbe, Mary F; van den Hoorn, Wolbert; Hodges, Paul W

    2018-04-01

    Prospective longitudinal study. To determine whether systemic cytokines and C-reactive protein (CRP) during an acute episode of low back pain (LBP) differ between individuals who did and did not recover by 6 months and to identify sub-groups based on patterns of inflammatory, psychological, and sleep features associated with recovery/non-recovery. Systemic inflammation is observed in chronic LBP and may contribute to the transition from acute to persistent LBP. Longitudinal studies are required to determine whether changes present early or develop over time. Psychological and/or sleep-related factors may be related. Individuals within 2 weeks of onset of acute LBP (N = 109) and pain-free controls (N = 55) provided blood for assessment of CRP, tumor necrosis factor (TNF), interleukin-6 (IL-6) and interleukin-1β, and completed questionnaires related to pain, disability, sleep, and psychological status. LBP participants repeated measurements at 6 months. Biomarkers were compared between LBP and control participants at baseline, and in longitudinal (baseline/6 months) analysis, between unrecovered (≥pain and disability), partially recovered (reduced pain and/or disability) and recovered (no pain and disability) participants at 6 months. We assessed baseline patterns of inflammatory, psychological, sleep, and pain data using hierarchical clustering and related the clusters to recovery (% change in pain) at 6 months. CRP was higher in acute LBP than controls at baseline. In LBP, baseline CRP was higher in the recovered than non-recovered groups. Conversely, TNF was higher at both time-points in the non-recovered than recovered groups. Two sub-groups were identified that associated with more ("inflammatory/poor sleep") or less ("high TNF/depression") recovery. This is the first evidence of a relationship between an "acute-phase" systemic inflammatory response and recovery at 6 months. High inflammation (CRP/IL-6) was associated with good recovery, but specific

  10. A Virtual Clinical Trial of FDG-PET Imaging of Breast Cancer: Effect of Variability on Response Assessment1

    OpenAIRE

    Harrison, Robert L; Elston, Brian F; Doot, Robert K; Lewellen, Thomas K; Mankoff, David A; Kinahan, Paul E

    2014-01-01

    INTRODUCTION: There is growing interest in using positron emission tomography (PET) standardized uptake values (SUVs) to assess tumor response to therapy. However, many error sources compromise the ability to detect SUV changes. We explore relationships between these errors and overall SUV variability. METHODS: We used simulations in a virtual clinical trial framework to study impacts of error sources from scanning and analysis effects on assessment of SUV changes. We varied tumor diameter, s...

  11. Optical and energy dependent response of the alanine gel solution produced at IPEN to clinical photons and electrons beams

    International Nuclear Information System (INIS)

    Silva, Cleber F.

    2011-01-01

    The DL-Alanine (C 3 H 7 NO 2 ) is an amino acid tissue equivalent traditionally used as standard dosimetric material in EPR dosimetry. Recently, it has been studied to be applied in gel dosimetry, considering that the addition of Alanine in the Fricke gel solution improves the production of ferric ions radiation induced. The spectrophotometric evaluation technique can be used comparing the two spectrum wavelengths bands: 457 nm band that corresponds to ferrous ions and 588 nm band that corresponds to ferric ions concentration to evaluate the dosimetric properties of this material. The performance of the Alanine gel solution developed at IPEN has been firstly studied using the spectrophotometric technique aiming to apply this material to 3D clinical doses evaluations using MRI technique. In this work, the optical and the energy dependent response of this solution submitted to clinical photons and electrons beams were studied. Different batches of gel solutions were prepared and maintained at low temperature during 12 h to solidification. Before irradiation, the samples were maintained during 1 h at room temperature. The photons and electrons irradiations were carried out using a Varian 2100C Medical Linear Accelerator of the Radiotherapy Department of the Hospital das Clinicas of the University of Sao Paulo with absorbed doses between 1 and 40 Gy; radiation field of 10 x 10 cm 2 ; photon energies of 6 MeV and 15 MeV; and electron with energies between 6 and 15 MeV. The obtained results indicate that signal response dependence for clinical photons and electrons beams, to the same doses, for Alanine gel dosimeter is better than 3.6 % (1σ), and the energy dependence response, to the same doses, is better 3% (1σ) for both beams. These results indicate that the same calibration factor can be used and the optical response is energy independent in the studied dose range and clinical photons and electrons beams energies. (author)

  12. Difference in clinical presentation, immunology profile and treatment response of type 1 autoimmune hepatitis between United Kingdom and Singapore patients

    OpenAIRE

    Than, Nwe Ni; Ching, Doreen Koay Siew; Hodson, James; McDowell, Patrick; Mann, Jake; Gupta, Ravi; Salazar, Ennaliza; Ngu, Jing Hieng; Oo, Ye Htun

    2016-01-01

    Background Autoimmune hepatitis (AIH) is an immune-mediated liver disease of unknown etiology. Increasing incidence of AIH in Asian patients has been reported. However, the phenotypic difference of Asian patients in Europe and Asia has still not been explored. Aim To evaluate the clinical presentation, biochemical and immunological profiles, treatment response and survival outcome of type 1 AIH from two tertiary liver transplant centres (United Kingdom and Singapore). Method Patients who fulf...

  13. Good governance for pension schemes

    CERN Document Server

    Thornton, Paul

    2011-01-01

    Regulatory and market developments have transformed the way in which UK private sector pension schemes operate. This has increased demands on trustees and advisors and the trusteeship governance model must evolve in order to remain fit for purpose. This volume brings together leading practitioners to provide an overview of what today constitutes good governance for pension schemes, from both a legal and a practical perspective. It provides the reader with an appreciation of the distinctive characteristics of UK occupational pension schemes, how they sit within the capital markets and their social and fiduciary responsibilities. Providing a holistic analysis of pension risk, both from the trustee and the corporate perspective, the essays cover the crucial role of the employer covenant, financing and investment risk, developments in longevity risk hedging and insurance de-risking, and best practice scheme administration.

  14. Armonización de estándares de calidad para ensayos clínicos. Norma ISO 9001-Guía de Buena Práctica Clínica Harmonization of quality standards for clinical trials. ISO-9001 standard and Guide of Good Clinical Practice

    Directory of Open Access Journals (Sweden)

    Sandra Álvarez Guerra

    2011-09-01

    Full Text Available El proceso de ensayo clínico necesario para autorizar el uso de nuevos medicamentos en humanos es extenso y complejo. Para garantizar la calidad y estandarizar este proceso, la Conferencia Internacional de Armonización ha establecido la Guía E6 para la Buena Práctica Clínica, la cual ha sido asumida y adaptada por las agencias reguladoras nacionales para estandarizar este proceso en sus países. Otra norma que permite garantizar calidad es la ISO 9001:2008, que establece requisitos para implementar Sistema de Gestión de Calidad. El objetivo de este trabajo consistió en establecer elementos comunes que demuestren la armonización entre la Buena Práctica Clínica de la Conferencia Internacional de Armonización, la Buena Práctica Clínica cubana y la ISO 9001:2008 para su implementación en sistemas de calidad para los ensayos clínicos. Para ello se realizó el estudio de estos estándares analizando qué tienen en común en su aplicación para el proceso de ensayo clínico. Se determinó que el cliente, los proveedores, el enfoque de proceso, la documentación, la dirección, las revisiones, la forma de realización de la investigación y la mejora de la calidad son puntos comunes para los cuales se establecen requisitos a cumplir. Esto permitió afirmar que los estándares estudiados al ser usados de conjunto en el proceso de ensayo clínico, contribuyen a elevar la calidad, pues no existe ningún aspecto contemplado en ellos que refleje contradicción sino aspectos comunes que permiten su armonización y uso.A clinical trial is an extensive, complex and necessary process to authorize the use of new medications in humans. For the purpose of assuring the quality and the standardization of this process, the International Conference of Harmonization (ICH set the Guideline E6 for Good Clinical Practice, which has been adopted and adapted by the national regulatory agencies. There also exists another standard to guarantee quality in the

  15. Predicting beneficial effects of atomoxetine and citalopram on response inhibition in Parkinson's disease with clinical and neuroimaging measures

    Science.gov (United States)

    Ye, Zheng; Rae, Charlotte L.; Nombela, Cristina; Ham, Timothy; Rittman, Timothy; Jones, Peter Simon; Rodríguez, Patricia Vázquez; Coyle‐Gilchrist, Ian; Regenthal, Ralf; Altena, Ellemarije; Housden, Charlotte R.; Maxwell, Helen; Sahakian, Barbara J.; Barker, Roger A.; Robbins, Trevor W.

    2016-01-01

    Abstract Recent studies indicate that selective noradrenergic (atomoxetine) and serotonergic (citalopram) reuptake inhibitors may improve response inhibition in selected patients with Parkinson's disease, restoring behavioral performance and brain activity. We reassessed the behavioral efficacy of these drugs in a larger cohort and developed predictive models to identify patient responders. We used a double‐blind randomized three‐way crossover design to investigate stopping efficiency in 34 patients with idiopathic Parkinson's disease after 40 mg atomoxetine, 30 mg citalopram, or placebo. Diffusion‐weighted and functional imaging measured microstructural properties and regional brain activations, respectively. We confirmed that Parkinson's disease impairs response inhibition. Overall, drug effects on response inhibition varied substantially across patients at both behavioral and brain activity levels. We therefore built binary classifiers with leave‐one‐out cross‐validation (LOOCV) to predict patients’ responses in terms of improved stopping efficiency. We identified two optimal models: (1) a “clinical” model that predicted the response of an individual patient with 77–79% accuracy for atomoxetine and citalopram, using clinically available information including age, cognitive status, and levodopa equivalent dose, and a simple diffusion‐weighted imaging scan; and (2) a “mechanistic” model that explained the behavioral response with 85% accuracy for each drug, using drug‐induced changes of brain activations in the striatum and presupplementary motor area from functional imaging. These data support growing evidence for the role of noradrenaline and serotonin in inhibitory control. Although noradrenergic and serotonergic drugs have highly variable effects in patients with Parkinson's disease, the individual patient's response to each drug can be predicted using a pattern of clinical and neuroimaging features. Hum Brain Mapp 37:1026–1037

  16. From the Consulting Room to the Court Room? Taking the Clinical Model of Responsibility Without Blame into the Legal Realm

    Science.gov (United States)

    Lacey, Nicola; Pickard, Hanna

    2013-01-01

    Within contemporary penal philosophy, the view that punishment can only be justified if the offender is a moral agent who is responsible and hence blameworthy for their offence is one of the few areas on which a consensus prevails. In recent literature, this precept is associated with the retributive tradition, in the modern form of ‘just deserts’. Turning its back on the rehabilitative ideal, this tradition forges a strong association between the justification of punishment, the attribution of responsible agency in relation to the offence, and the appropriateness of blame. By contrast, effective clinical treatment of disorders of agency employs a conceptual framework in which ideas of responsibility and blameworthiness are clearly separated from what we call ‘affective blame’: the range of hostile, negative attitudes and emotions that are typical human responses to criminal or immoral conduct. We argue that taking this clinical model of ‘responsibility without blame’ into the legal realm offers new possibilities. Theoretically, it allows for the reconciliation of the idea of ‘just deserts’ with a rehabilitative ideal in penal philosophy. Punishment can be reconceived as consequences—typically negative but occasionally not, so long as they are serious and appropriate to the crime and the context—imposed in response to, by reason of, and in proportion to responsibility and blameworthiness, but without the hard treatment and stigma typical of affective blame. Practically, it suggests how sentencing and punishment can better avoid affective blame and instead further rehabilitative and related ends, while yet serving the demands of justice. PMID:24771953

  17. Who Gets the Goods?

    DEFF Research Database (Denmark)

    Arndt, Thomas Channing; Tarp, Finn

    2001-01-01

    We employ a computable general equilibrium approach to examine the effects of alternative food aid distribution schemes for drought-response food aid to Mozambique. Alternative schemes have very distinct impacts on household welfare and prices. Compared with monetization of food aid by government......, direct distribution to households (by population shares) strongly benefits rural households. Even assuming that government cannot target food aid strictly at drought-stricken rural people, our results indicate that, when improving household welfare is the primary goal of the food aid, direct distribution...

  18. Neurophysiological and clinical responses to rituximab in patients with anti-MAG polyneuropathy.

    Science.gov (United States)

    Zara, Gabriella; Zambello, Renato; Ermani, M

    2011-12-01

    Rituximab treatment has shown clinical improvement in anti-myelin associated glycoprotein (MAG) polyneuropathy. We analyzed scores of clinical scales and the most sensitive electrophysiological parameters before and after immunomodulating treatment with rituximab in a group of patients affected by anti-MAG demyelinating polyneuropathy. Clinical scores, the percentage of CD20 B-lymphocytes, anti-MAG antibody titers and electrophysiological data in 7 patients with anti-MAG polyneuropathy were analyzed. The patients were examined before a cycle with rituximab, 6, 12 and 24 months after the end of the treatment. Two patients were treated with rituximab additional cycles and re-evaluated 48 months after the first treatment. There were no evident correlation between anti-MAG serum antibody titers or clinical scales and electrodiagnostic data. Significant decrease in the proportion of CD20 B-lymphocytes was observed. Significant anti-MAG antibodies titers reduction was detected after re-treatment. At follow-up, pinprik sensation and two point discrimination presented a significant improvement compared with the score before treatment. In our patients, rituximab did not improve any electrophysiological data. No correlation with anti-MAG serum antibodies course was found. With rituximab only pin sensibility improved. Rituximab re-treatment significantly reduces anti-MAG serum antibodies titers but improves only small fibers sensibility. Copyright © 2011 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

  19. Commentary: Compliance education and training: a need for new responses in clinical research.

    Science.gov (United States)

    Steinberg, Mindy J; Rubin, Elaine R

    2010-03-01

    Increasing regulatory mandates, heightened concerns about compliance, accountability, and liability, as well as a movement toward organizational integration are prompting assessment and transformation in education and training programs at academic health centers, particularly with regard to clinical research compliance. Whereas education and training have become a major link between all research and compliance functions, the infrastructure to support and sustain these activities has not been examined in any systematic, comprehensive fashion, leaving many critical interrelated issues unaddressed. Through a series of informal interviews in late 2008 with chief compliance officers and other senior leadership at 10 academic health centers, the authors studied the organization, management, and administration of clinical research compliance education and training programs. The interviews revealed that while clinical research compliance education and training are undergoing growth and expansion to accommodate a rapidly changing regulatory environment and research paradigm, there are no strategies or models for development. The decentralization of education and training is having serious consequences for leadership, resources, and effectiveness. The authors recommend that leaders of academic health centers conduct a comprehensive analysis of clinical research compliance education and training as clinical trials administration undergoes change, focusing on strategic planning, communication, collaboration across the institution, and program evaluation.

  20. A sheeppox outbreak in Morocco: isolation and identification of virus responsible for the new clinical form of disease.

    Science.gov (United States)

    Zro, Khalil; Zakham, Fathiah; Melloul, Marouane; El Fahime, Elmostafa; Ennaji, Moulay Mustapha

    2014-01-27

    Sheeppoxvirus (SPPV) is a member of the Capripoxvirus genus of the Poxviridae family, which causes significant economic losses in Morocco. The resurgence of the sheeppox disease during 2010 was characterized by an emergence of a classical nodular form for the first time in Morocco. However, little is known about the virus strain responsible for nodular form. In this study, thirty three sheep, from the eastern region of Morocco, clinically infected were examined and dead animals were autopsied.A rapid diagnostic assay for SPPV using different type of clinical samples would be useful for outbreak management. The aim of this work was to isolate the virus strain responsible for nodular form and we identified and compared by phylogenetic analysis the field strain with Moroccan vaccine strain targeting the thymidine kinase (TK) gene and the chemokine analogue receptor of interleukin (IL8) gene. Further, it was important to investigate and validate a real-time PCR using different clinical and post-mortem samples to manage epidemic sheeppox disease. The nodular form of sheeppox disease observed in Morocco was clinically characterized by fever, depression, lacrimation, diarrhea in lambs and nodule. At necropsy, the most affected organ was the lung. The etiological strain was successfully isolated from lung nodule in a dead lamb and was identified by using real-time PCR that has been tested and validated on different types of clinical and post mortem samples from naturally infected animals. Sequence and phylogenetic analysis of TK and IL8 gene showed that there was a very close relationship between field and vaccine strain. They were clustered within other SPPV strains. In the current study, we show for the first time the nodular form of sheeppox in Morocco. We demonstrate a robust real-time PCR-based diagnostic assay to detect the sheeppox virus in multiple sample that can be implemented to efficiently manage the disease outbreak. Our study also offers the prospect for

  1. Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact.

    Science.gov (United States)

    Tatarewicz, Suzanna M; Mytych, Daniel T; Manning, Marta Starcevic; Swanson, Steven J; Moxness, Michael S; Chirmule, Narendra

    2014-06-01

    All therapeutic proteins have the potential to induce anti-drug antibodies (ADA). Clinically relevant ADA can impact efficacy and/or safety of a biological therapeutic. Immunogenicity assessment strategy evaluates binding and neutralizing ADA, and the need for additional characterization (e.g., epitope, titer and so on) is determined using a risk-based approach. The choice of characterization assays depends on the type, application and immunogenicity of the therapeutic. ADA characterization can impact the interpretation of the risk profile of a given therapeutic, and offers insight into opportunities for risk mitigation and management. This article describes common ADA characterization methods. Strategic assessment and characterization of clinically relevant ADA are discussed, in order to support clinical options for safe and effective patient care and disease management.

  2. Value of the free light chain analysis in the clinical evaluation of response in multiple myeloma patients receiving anti-myeloma therapy

    DEFF Research Database (Denmark)

    Toftmann Hansen, Charlotte; Pedersen, Per T.; Jensen, Bo Amdi

    Value of the free light chain analysis in the clinical evaluation of response in multiple myeloma patients receiving anti-myeloma therapy.......Value of the free light chain analysis in the clinical evaluation of response in multiple myeloma patients receiving anti-myeloma therapy....

  3. Response to Bodin and Grote regarding postdoctoral recruitment in clinical neuropsychology.

    Science.gov (United States)

    Nelson, Aaron; Bilder, Robert M; O'Connor, Margaret; Brandt, Jason; Weintraub, Sandra; Bauer, Russell M

    2016-07-01

    Bodin and Grote convey their opinion that the field of clinical neuropsychology would be best served by a match system for recruitment into postdoctoral training. We critically review their arguments and offer an alternative point of view. Our view considers the current state of the match system in neuropsychology, incorporates comparisons with other disciplines that rely on a match system, and addresses the role of postdoctoral training and the specialization that takes shape at this level. We make recommendations aimed at promoting greater unity among postdoctoral training programs with the goal of focusing leadership efforts on advancing our shared mission of providing the highest quality training in clinical neuropsychology.

  4. Hydroxyurea responses in clinically varied beta, HbE-beta thalassaemia and sickle cell anaemia patients of Eastern India.

    Science.gov (United States)

    Chatterjee, Tridip; Chakravarty, Amit; Chakravarty, Sudipa

    2018-05-01

    The haematological and clinical response to hydroxyurea was estimated in HbE-beta, beta thalassaemia and sickle cell anaemia patients of Eastern India, with variable clinical severity and transfusion requirement to determine whether hydroxyurea can help these patients to maintain their steady haemoglobin level without blood transfusions. Three hundred patients (189 HbE-beta thalassaemia, 95 beta thalassaemia and 16 other haemoglobinopathies including sickle cell anaemia) were selected for hydroxyurea therapy and were followed up for 48-60 months. Results suggest significant response to hydroxyurea therapy in 19 beta and 99 HbE-beta patients in the transfusion-dependent group (GR-I). All of them became transfusion-independent while on hydroxyurea therapy. The majority of responding patients were IVS1-5(G-C) in one of their alleles in HbE-beta cases (83 out of 119). Though IVS1-5(G-C) was found to be the commonest mutation in our selected patients, the mutational background of the patients does not found to have any significant correlation with the response category towards hydroxyurea as per the results observed in our study. But, the drug works pretty well in most of the transfusion-dependent patients, as these patients were withdrawn from regular blood transfusion. At the same time, partial or no response to the drug hydroxyurea was also recorded in our study.

  5. Clinical responsiveness of self-report functional assessment measures for children with juvenile idiopathic arthritis undergoing intraarticular corticosteroid injections.

    Science.gov (United States)

    Brown, G Ted; Wright, F Virginia; Lang, Bianca A; Birdi, Nina; Oen, Kim; Stephens, Derek; McComas, Joan; Feldman, Brian M

    2005-12-15

    The Childhood Health Assessment Questionnaire (CHAQ), Juvenile Arthritis Functional Assessment Report (JAFAR), and Juvenile Arthritis Functional Status Index (JASI) are widely used functional measures for juvenile idiopathic arthritis (JIA) that differ in content, format, and completion time. We compared the responsiveness and child-parent agreement of the JAFAR, CHAQ, and JASI in a prospective, multicenter study. Children and adolescents from 5 rheumatology centers were enrolled. Subjects were about to undergo therapy (intraarticular corticosteroid injections [IAS] and methotrexate or hip surgery (MTX/hip]) expected to produce a functional improvement. All subjects were studied before the intervention and at 6 weeks and 6 months posttreatment. At each study visit, the 3 measures were administered in randomized, balanced order to both parents and children. A total of 92 subjects (mean age 12.8 years) were enrolled in the study, 74 of which were in the IAS group. The responsiveness of all 3 measures was moderate to strong. The standardized response mean at 6 weeks for the IAS group on the JAFAR, CHAQ, and JASI was 0.41 (95% confidence interval [95% CI] 0.18, 0.64), 0.70 (95% CI 0.47, 0.93), and 0.36 (95% CI 0.13, 0.59), respectively. The CHAQ was somewhat more responsive to change at 6 weeks (IAS group: relative efficiency 0.34 [JAFAR], 0.27 [JASI]), but less responsive at 6 months (MTX/hip group: relative efficiency 5.1 [JAFAR], 3.9 [JASI]). All 3 questionnaires showed acceptable parent-child agreement, and overall, there were few differences between the 3 questionnaires. The functional outcome measures currently used for JIA are all adequately responsive for use in trials or in the clinic setting. The choice of which measure to use should therefore be based on the time available for completion, the intended clinical/research use, and the depth of content required.

  6. Ethics and evidence-based medicine: fallibility and responsibility in clinical science

    National Research Council Canada - National Science Library

    Goodman, Kenneth W

    2003-01-01

    ... to their "clinical judgment." This tension- between efforts to make medical practice more scientific and the suspicions of many clinicians- has caused one of the greatest practical and ethical challenges in the history of the health professions. This incisive book reviews the history and conceptual origins of evidence-based practice and discusses ...

  7. A 'joint venture' model of recontacting in clinical genomics : Challenges for responsible implementation

    NARCIS (Netherlands)

    Dheensa, Sandi; Carrieri, Daniele; Kelly, Susan; Clarke, Angus; Doheny, Shane; Turnpenny, Peter; Lucassen, Anneke

    Advances in genomics often lead healthcare professionals (HCPs) to learn new information, e.g., about reinterpreted variants that could have clinical significance for patients seen previously. A question arises of whether HCPs should recontact these former patients. We present some findings

  8. Pain response of healthy workers following a functional capacity evaluation and implications for clinical interpretation

    NARCIS (Netherlands)

    Soer, Remko; Groothoff, Johan W; Geertzen, Jan H B; van der Schans, Cees; Reesink, David D; Reneman, Michiel F

    BACKGROUND AND AIM: Functional Capacity Evaluations (FCEs) are used to quantify physical aspects of work capacity. Safety is a critical issue for clinical use of an FCE. Patients with Chronic Low Back Pain (CLBP) are known to report a temporary increase in pain following an FCE, but it is not known