Science.gov

Sample records for additional clinical benefit

  1. Clinical effects of sulphite additives.

    PubMed

    Vally, H; Misso, N L A; Madan, V

    2009-11-01

    Sulphites are widely used as preservative and antioxidant additives in the food and pharmaceutical industries. Topical, oral or parenteral exposure to sulphites has been reported to induce a range of adverse clinical effects in sensitive individuals, ranging from dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhoea to life-threatening anaphylactic and asthmatic reactions. Exposure to the sulphites arises mainly from the consumption of foods and drinks that contain these additives; however, exposure may also occur through the use of pharmaceutical products, as well as in occupational settings. While contact sensitivity to sulphite additives in topical medications is increasingly being recognized, skin reactions also occur after ingestion of or parenteral exposure to sulphites. Most studies report a 3-10% prevalence of sulphite sensitivity among asthmatic subjects following ingestion of these additives. However, the severity of these reactions varies, and steroid-dependent asthmatics, those with marked airway hyperresponsiveness, and children with chronic asthma, appear to be at greater risk. In addition to episodic and acute symptoms, sulphites may also contribute to chronic skin and respiratory symptoms. To date, the mechanisms underlying sulphite sensitivity remain unclear, although a number of potential mechanisms have been proposed. Physicians should be aware of the range of clinical manifestations of sulphite sensitivity, as well as the potential sources of exposure. Minor modifications to diet or behaviour lead to excellent clinical outcomes for sulphite-sensitive individuals.

  2. Benefits of dietary fiber in clinical nutrition.

    PubMed

    Klosterbuer, Abby; Roughead, Zamzam Fariba; Slavin, Joanne

    2011-10-01

    Dietary fiber is widely recognized as an important part of a healthy diet and is a common addition to enteral nutrition (EN) formulas. Fiber sources differ in characteristics such as solubility, fermentability, and viscosity, and it is now well known that different types of fiber exert varying physiological effects in the body. Clinical studies suggest fiber can exert a wide range of benefits in areas such as bowel function, gut health, immunity, blood glucose control, and serum lipid levels. Although early clinical nutrition products contained fiber from a single source, it is now thought that blends of fiber from multiple sources more closely resemble a regular diet and may provide a greater range of benefits for the patient. Current recommendations support the use of dietary fiber in clinical nutrition when no contraindications exist, but little information exists about which types and combinations of fibers provide the relevant benefit in certain patient populations. This article summarizes the different types of fiber commonly added to EN products and reviews the current literature on the use of fiber blends in clinical nutrition.

  3. 42 CFR 417.592 - Additional benefits requirement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) General rules. (1) An HMO or CMP that has an APCRP (as determined under § 417.590) greater than its ACR... least equal to the difference between the APCRP and the proposed ACR. (b) Options—(1) Additional... the APCRP and the ACR. (4) Combination of additional benefits and withholding in a stabilization...

  4. 45 CFR 155.170 - Additional required benefits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Additional required benefits. 155.170 Section 155.170 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH CARE ACCESS EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED STANDARDS UNDER THE AFFORDABLE CARE ACT...

  5. Non-valvular atrial fibrillation patients with none or one additional risk factor of the CHA2DS2-VASc score. A comprehensive net clinical benefit analysis for warfarin, aspirin, or no therapy.

    PubMed

    Lip, Gregory Y H; Skjøth, Flemming; Nielsen, Peter B; Larsen, Torben Bjerregaard

    2015-10-01

    Oral anticoagulation (OAC) to prevent stroke has to be balanced against the potential harm of serious bleeding, especially intracranial haemorrhage (ICH). We determined the net clinical benefit (NCB) balancing effectiveness and safety of no antithrombotic therapy, aspirin and warfarin in AF patients with none or one stroke risk factor. Using Danish registries, we determined NCB using various definitions intrinsic to our cohort (Danish weights at 1 and 5 year follow-up), with risk weights which were derived from the hazard ratio (HR) of death following an event, relative to HR of death after ischaemic stroke. When aspirin was compared to no treatment, NCB was neutral or negative for both risk strata. For warfarin vs no treatment, NCB using Danish weights was neutral where no risk factors were present and using five years follow-up. For one stroke risk factor, NCB was positive for warfarin vs no treatment, for one year and five year follow-up. For warfarin vs aspirin use in patients with no risk factors, NCB was positive with one year follow-up, but neutral with five year follow-up. With one risk factor, NCB was generally positive for warfarin vs aspirin. In conclusion, we show a positive overall advantage (i.e. positive NCB) of effective stroke prevention with OAC, compared to no therapy or aspirin with one additional stroke risk factor, using Danish weights. 'Low risk' AF patients with no additional stroke risk factors (i.e.CHA2DS2-VASc 0 in males, 1 in females) do not derive any advantage (neutral or negative NCB) with aspirin, nor with warfarin therapy in the long run.

  6. Benefits of additives application during combustion of phytomass

    NASA Astrophysics Data System (ADS)

    Palacka, Matej; Vician, Peter; Holubčík, Michal; Jandačka, Jozef

    2016-06-01

    Phytomass, particularly wheat straw as a source of energy has countless benefits, but it has many problems in its direct burn too. The worst problem is the ash flow temperature. The aim of study was to analyze and reduce the problems of the wheat straw combustion. The experiment was conducted under realistic conditions. In this paper was implemented analysis of ash features with and without adding additives into the wheat straw. Selected samples were laboratory processed and examined. The result of the work was the impact of additional additives for ash features.

  7. Clinical benefits of metformin in gynecologic oncology

    PubMed Central

    IMAI, ATSUSHI; ICHIGO, SATOSHI; MATSUNAMI, KAZUTOSHI; TAKAGI, HIROSHI; YASUDA, KEIGO

    2015-01-01

    Evidence has suggested that diabetes may contribute to the initiation and progression of specific types of cancer. Metformin, a biguanide, has become the preferred first-line therapy for the treatment of type 2 diabetes. Metformin is inexpensive, has a proven safety profile and is able to be safely combined with additional antidiabetic agents. In addition to the well-established antidiabetic effects of metformin, there has also been notable interest in its antitumor properties. The present review discusses the emerging role of metformin as an example of an existing drug, used worldwide in the treatment of diabetes, which has been demonstrated to exert significant in vitro and in vivo anticancer activities and has thus been investigated in clinical trials. In gynecologic oncology, metformin has been suggested to exhibit significant treatment efficacy against endometrial cancer. Three studies have demonstrated the potential therapeutic effects of metformin on the survival outcome of patients with ovarian cancer and in ovarian cancer prevention. However, this evidence was based on observational studies. Metformin has been shown to exert no statistically significant beneficial effect on cervical cancer incidence or mortality. By cancer site, the current limited insights highlight the need for clinical investigations and better-designed studies, along with evaluation of the effects of metformin on cancer at other sites. PMID:26622536

  8. Additionality of global benefits and financial additionality in the context of the AIJ negotiations

    SciTech Connect

    Puhl, I.

    1996-12-31

    The Conference of the Party at their first meeting (COP1) took a decision regarding criteria for joint implementation as indicated in Art. 4.2 (a) of the FCCC which established a pilot phase for activities implemented jointly (AIJ) under the pilot phase. Besides some more technical issues this decision specified that such measures should bring about real, measurable and long-term environmental benefits related to the mitigation of climate change that would not have occurred in the absence of such activities. It also established that the financing of AIJ shall be additional to the financial obligations of developed country parties. These two requirements are called the additionality criteria for AIJ. The first refers to the realness of GHG emission abatement (which means reduction compared to a baseline) whereas the second describes that funds earmarked for AIJ have no other objective (i.e. profit making, export promotion) but to reduce GHG emissions to avoid the free-riding of investors and subsequently developed country parties. The reporting framework as well as the reporting requirements under national programs do not specify further the two types of additionality and even though research focuses on issues like baseline determination there has been no attempt so far to identify approaches which contribute towards defining strict and practicable methods and guidelines to frame additionality criteria. The first FCCC assessment of pilot project reporting revealed that in the reporting of activities, emissions additionality often remained unclear, especially in cases where AIJ was only a portion of an existing or already planned project, and that there is a point about how to account for financial additionality. It subsequently proposed to develop a uniform approach to baseline determination and the assessment of emission (reduction) additionality and financial additionality.

  9. 20 CFR 410.535 - Reductions; effect of an additional claim for benefits.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Reductions; effect of an additional claim for benefits. 410.535 Section 410.535 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Payment of Benefits §...

  10. 20 CFR 410.535 - Reductions; effect of an additional claim for benefits.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Reductions; effect of an additional claim for benefits. 410.535 Section 410.535 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, TITLE IV-BLACK LUNG BENEFITS (1969- ) Payment of Benefits §...

  11. Intimate Behavior and Assessment of Benefits in Clinical Groups.

    ERIC Educational Resources Information Center

    Shadish, William R., Jr.

    1984-01-01

    Developed three measures of clinical group benefits and presented empirical evidence (N=27) explicating the logic of the Interpersonal Relations Scale as an assessment device. Conceptualized the benefits of clinical groups as the fostering of intimacy skills by which group members learn about themselves, others, and their interpersonal…

  12. Focal masses in a non-cirrhotic liver: The additional benefit of CEUS over baseline imaging.

    PubMed

    Chiorean, L; Cantisani, V; Jenssen, C; Sidhu, P S; Baum, U; Dietrich, C F

    2015-09-01

    Incidentally detected focal liver lesions are commonly encountered in clinical practice presenting a challenge in the daily department work flow. Guidelines for the management of incidental focal liver lesions have been published but comments, illustrations and recommendations regarding practical issues are crucial. The unique features of contrast-enhanced ultrasound in non-invasive assessment of focal liver lesion enhancement throughout the vascular phases in real-time has allowed an impressive improvement in the diagnostic accuracy of ultrasound. We highlight the additional benefit of contrast-enhanced ultrasound over conventional B-mode ultrasound imaging in detection, characterization, differential and final diagnosis of focal liver lesions, as well as for liver metastases screening. The current roles of cross-sectional imaging are explained in detail, with indications and limitations for each procedure. The advantages of CEUS, such as non-ionizing radiation exposure, cost benefits, non-iodinate contrast agents, and repeatability are also described ultimately improving patient management.

  13. The benefit of additional oviposition targets for a polyphagous butterfly.

    PubMed

    Johansson, Josefin; Bergström, Anders; Janz, Niklas

    2007-01-01

    While the reasons for the prevalence of specialists over generalists among herbivorous insects have been at the focus of much interest, less effort has been put into understanding the polyphagous exceptions. Recent studies have suggested that these exceptions may be important for insect diversification, which calls for a better understanding of the potential factors that can lead to an increased host plant repertoire. Females of the Nymphalid butterfly, Polygonia c-album, were used to test if egg output and/or likelihood of finding a host increased with the addition of a secondary host. There was no effect of prior eggs on the host for willingness to oviposit on a plant. The main experiments were conducted both in small laboratory cages and in large outdoor experimental arenas. No positive effect was found when another oviposition target was added in small cages in the laboratory. On the other hand, in the outdoor arenas the females more often found a host to oviposit on and had a higher egg output when they had access to an additional host, even though the second host was lower in their preference hierarchy. The difference between these experiments was attributed to searching for acceptable host plants within a patch, a factor that was included in the large cages but not in the small. When host availability is limited, adding oviposition targets can potentially act to counterbalance specialization and thus favor the evolution of generalization.

  14. Clinical writing: additional ethical and practical issues.

    PubMed

    Woodhouse, Susan S

    2012-03-01

    The recommendations by Sieck (2011, Obtaining clinical writing informed consent versus using client disguise and recommendations for practice, Psychotherapy, 49, pp. 3-11.) are a helpful starting point for considering the ethical issues involved in the decision to seek or not to seek informed consent from clients before writing about them. Sieck makes a compelling case for the idea that there are circumstances in which the most ethical choice would be to engage in clinical writing about a client without seeking informed consent, but instead disguising the client's identity. The present response raises a number of questions not considered in the article by Sieck. First, how should one disguise a case? Moreover, how should one assess whether the disguise is sufficient to preserve confidentiality while not distorting the clinical material to the point that the material is no longer useful to the field? Second, how can we estimate the likelihood of clients reading clinical writing, particularly in the age of the Internet? Given that psychologist-authored blogs that include reference to clinical material are beginning to emerge, it is crucial that we engage in a much deeper dialogue about the ethics of clinical writing. Third, how does the presentation of clinical material influence public perceptions of psychotherapy and confidentiality? If these public perceptions, in turn, could influence the likelihood of seeking psychotherapy, might these attitudes be important to consider in ethical thinking about clinical writing? Finally, where do we draw the line between clinical writing and single case study research (which requires informed consent)?

  15. Clinical writing: additional ethical and practical issues.

    PubMed

    Woodhouse, Susan S

    2012-03-01

    The recommendations by Sieck (2011, Obtaining clinical writing informed consent versus using client disguise and recommendations for practice, Psychotherapy, 49, pp. 3-11.) are a helpful starting point for considering the ethical issues involved in the decision to seek or not to seek informed consent from clients before writing about them. Sieck makes a compelling case for the idea that there are circumstances in which the most ethical choice would be to engage in clinical writing about a client without seeking informed consent, but instead disguising the client's identity. The present response raises a number of questions not considered in the article by Sieck. First, how should one disguise a case? Moreover, how should one assess whether the disguise is sufficient to preserve confidentiality while not distorting the clinical material to the point that the material is no longer useful to the field? Second, how can we estimate the likelihood of clients reading clinical writing, particularly in the age of the Internet? Given that psychologist-authored blogs that include reference to clinical material are beginning to emerge, it is crucial that we engage in a much deeper dialogue about the ethics of clinical writing. Third, how does the presentation of clinical material influence public perceptions of psychotherapy and confidentiality? If these public perceptions, in turn, could influence the likelihood of seeking psychotherapy, might these attitudes be important to consider in ethical thinking about clinical writing? Finally, where do we draw the line between clinical writing and single case study research (which requires informed consent)? PMID:22369079

  16. [Requirements for drug approval and additional benefits assessment: Regulatory aspects and experiences].

    PubMed

    Broich, K; Löbker, W; Schulte, A; Beinlich, P; Müller, T

    2016-04-01

    The early assessment of benefits of newly approved drugs with novel active substances or new applications, which came into force on 1 January 2011 still represents a challenge to all parties involved. This article highlights the definitions, regulatory requirements and interaction between drug marketing approval and early assessment of benefits in Germany. The constellation of an extensively harmonized European and even international drug authorization process with a predominantly national regulation of drug reimbursement situation inevitably causes friction, which could be markedly reduced through early joint advisory discussions during the planning phase for pivotal clinical trials. During the year 2015 the Federal Institute for Drugs and Medical Devices (BfArM) carried out 300 scientific advice procedures of which 34 were concerned with applications in the field of indications for the central nervous system (CNS). In comparison 98 advisory meetings were held by the Federal Joint Committee (G-BA) of which the BfArM provided advice in 12 instances and in 2 cases on CNS indications. Study design, endpoints and appropriate comparative therapies are the key issues in exchanges and discussions between the BfArM, the G‑BA and applicants. Under these aspects the BfArM and G‑BA promote an early and consistent involvement in early advice procedures regarding the prerequisites for drug approval and assessment of additional benefits.

  17. [Requirements for drug approval and additional benefits assessment: Regulatory aspects and experiences].

    PubMed

    Broich, K; Löbker, W; Schulte, A; Beinlich, P; Müller, T

    2016-04-01

    The early assessment of benefits of newly approved drugs with novel active substances or new applications, which came into force on 1 January 2011 still represents a challenge to all parties involved. This article highlights the definitions, regulatory requirements and interaction between drug marketing approval and early assessment of benefits in Germany. The constellation of an extensively harmonized European and even international drug authorization process with a predominantly national regulation of drug reimbursement situation inevitably causes friction, which could be markedly reduced through early joint advisory discussions during the planning phase for pivotal clinical trials. During the year 2015 the Federal Institute for Drugs and Medical Devices (BfArM) carried out 300 scientific advice procedures of which 34 were concerned with applications in the field of indications for the central nervous system (CNS). In comparison 98 advisory meetings were held by the Federal Joint Committee (G-BA) of which the BfArM provided advice in 12 instances and in 2 cases on CNS indications. Study design, endpoints and appropriate comparative therapies are the key issues in exchanges and discussions between the BfArM, the G‑BA and applicants. Under these aspects the BfArM and G‑BA promote an early and consistent involvement in early advice procedures regarding the prerequisites for drug approval and assessment of additional benefits. PMID:27003322

  18. 20 CFR 725.309 - Additional claims; effect of a prior denial of benefits.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Additional claims; effect of a prior denial..., DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED CLAIMS FOR BENEFITS UNDER PART C OF TITLE IV OF THE FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED Filing of Claims §...

  19. How Does the Patient Benefit from Clinical PET?

    PubMed Central

    Sörensen, Jens

    2012-01-01

    Clinical molecular imaging by use of PET and PET/CT is increasingly important in routine oncological practice worldwide. A vast majority of clinical PET investigations are performed with [18F]-fluorodeoxyglucose (FDG), but there is a growing interest in novel molecular probes among scientists and clinicians. Beyond FDG, a small number of different tracers have been shown to be of clinical value. With a growing commercial interest in tracer development, many more are under investigation. This review provides some examples of clinical situations where tracers other than FDG have been found useful and an outlook towards technical and regulatory development needed to allow the full impact of clinical PET to benefit the individual patient. PMID:22768023

  20. Intelligent use and clinical benefits of electronic health records in rheumatoid arthritis.

    PubMed

    Carroll, Robert J; Eyler, Anne E; Denny, Joshua C

    2015-03-01

    In the past 10 years, electronic health records (EHRs) have had growing impact in clinical care. EHRs efficiently capture and reuse clinical information, which can directly benefit patient care by guiding treatments and providing effective reminders for best practices. The increased adoption has also lead to more complex implementations, including robust, disease-specific tools, such as for rheumatoid arthritis (RA). In addition, the data collected through normal clinical care is also used in secondary research, helping to refine patient treatment for the future. Although few studies have directly demonstrated benefits for direct clinical care of RA, the opposite is true for EHR-based research - RA has been a particularly fertile ground for clinical and genomic research that have leveraged typically advanced informatics methods to accurately define RA populations. We discuss the clinical impact of EHRs in RA treatment and their impact on secondary research, and provide recommendations for improved utility in future EHR installations.

  1. Are There Additional Benefits from Being in Small Classes for More than One Year?

    ERIC Educational Resources Information Center

    Konstantopoulos, Spyros; Li, Wei

    2012-01-01

    Evidence from Project STAR has suggested a considerable advantage of being in small classes in early grades. However, the extra benefits of additional years in small classes have not been discussed in detail. The present study examined the additional effects of being in small classes for more than 1 year. We find that once previous grade…

  2. Cochlear Implantation among Deaf Children with Additional Disabilities: Parental Perceptions of Benefits, Challenges, and Service Provision

    ERIC Educational Resources Information Center

    Zaidman-Zait, Anat; Curle, Deirdre; Jamieson, Janet R.; Chia, Ruth; Kozak, Frederick K.

    2015-01-01

    Although increasing numbers of children with additional disabilities are receiving cochlear implants (CIs), little is known about family perspectives of the benefits and the challenges of cochlear implantation in this pediatric population. This study examines perceptions among parents of deaf children with additional disabilities regarding…

  3. An Investigation of the Additive Benefits of Parent Dialogic Reading Techniques in Older Preschool Children

    ERIC Educational Resources Information Center

    Switalski, Sarah O'Neill

    2012-01-01

    This study examined the additive benefit of parent dialogic reading techniques in older, high-risk preschool children using multiple baseline design across participants, a single subject research design, as was as well as pre-test and post-test measures. Five preschoolers age-eligible to begin kindergarten the following school year participated.…

  4. 20 CFR 408.808 - What happens to your SVB payments if you begin receiving additional benefit income?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false What happens to your SVB payments if you begin receiving additional benefit income? 408.808 Section 408.808 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SPECIAL BENEFITS FOR CERTAIN WORLD WAR II VETERANS Suspensions and Terminations Suspension §...

  5. 20 CFR 408.808 - What happens to your SVB payments if you begin receiving additional benefit income?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false What happens to your SVB payments if you begin receiving additional benefit income? 408.808 Section 408.808 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SPECIAL BENEFITS FOR CERTAIN WORLD WAR II VETERANS Suspensions and Terminations Suspension §...

  6. 20 CFR 408.808 - What happens to your SVB payments if you begin receiving additional benefit income?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false What happens to your SVB payments if you begin receiving additional benefit income? 408.808 Section 408.808 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SPECIAL BENEFITS FOR CERTAIN WORLD WAR II VETERANS Suspensions and Terminations Suspension §...

  7. 20 CFR 408.808 - What happens to your SVB payments if you begin receiving additional benefit income?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false What happens to your SVB payments if you begin receiving additional benefit income? 408.808 Section 408.808 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SPECIAL BENEFITS FOR CERTAIN WORLD WAR II VETERANS Suspensions and Terminations Suspension §...

  8. 20 CFR 408.808 - What happens to your SVB payments if you begin receiving additional benefit income?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false What happens to your SVB payments if you begin receiving additional benefit income? 408.808 Section 408.808 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SPECIAL BENEFITS FOR CERTAIN WORLD WAR II VETERANS Suspensions and Terminations Suspension §...

  9. No Detectable Fertility Benefit from a Single Additional Mating in Wild Stalk-Eyed Flies

    PubMed Central

    Harley, Elisabeth; Fowler, Kevin; Cotton, Samuel

    2010-01-01

    Background Multiple mating by female insects is widespread, and the explanation(s) for repeated mating by females has been the subject of much discussion. Females may profit from mating multiply through direct material benefits that increase their own reproductive output, or indirect genetic benefits that increase offspring fitness. One particular direct benefit that has attracted significant attention is that of fertility assurance, as females often need to mate multiply to achieve high fertility. This hypothesis has never been tested in a wild insect population. Methodology/Principal Findings Female Malaysian stalk-eyed flies (Teleopsis dalmanni) mate repeatedly during their lifetime, and have been shown to be sperm limited under both laboratory and field conditions. Here we ask whether receiving an additional mating alleviates sperm limitation in wild females. In our experiment one group of females received a single additional mating, while a control group received an interrupted, and therefore unsuccessful, mating. Females that received an additional mating did not lay more fertilised eggs in total, nor did they lay proportionately more fertilised eggs. Female fertility declined significantly through time, demonstrating that females were sperm limited. However, receipt of an additional mating did not significantly alter the rate of this decline. Conclusions/Significance Our data suggest that the fertility consequences of a single additional mating were small. We discuss this effect (or lack thereof), and suggest that it is likely to be attributed to small ejaculate size, a high proportion of failed copulations, and the presence of X-linked meiotic drive in this species. PMID:21179210

  10. The Benefits of Exercise for the Clinically Depressed

    PubMed Central

    Craft, Lynette L.; Perna, Frank M.

    2004-01-01

    Millions of Americans suffer from clinical depression each year. Most depressed patients first seek treatment from their primary care providers. Generally, depressed patients treated in primary care settings receive pharmacologic therapy alone. There is evidence to suggest that the addition of cognitive-behavioral therapies, specifically exercise, can improve treatment outcomes for many patients. Exercise is a behavioral intervention that has shown great promise in alleviating symptoms of depression. The current review discusses the growing body of research examining the exercise-depression relationship that supports the efficacy of exercise as an adjunct treatment. Databases searched were Medline, PsycLit, PubMed, and SportsDiscus from the years 1996 through 2003. Terms used in the search were clinical depression, depression, exercise, and physical activity. Further, because primary care physicians deliver important mental health services to the majority of depressed patients, several specific recommendations are made regarding counseling these patients on the adoption and maintenance of exercise programs. PMID:15361924

  11. Health benefits of fruit and vegetables are from additive and synergistic combinations of phytochemicals.

    PubMed

    Liu, Rui Hai

    2003-09-01

    Cardiovascular disease and cancer are ranked as the first and second leading causes of death in the United States and in most industrialized countries. Regular consumption of fruit and vegetables is associated with reduced risks of cancer, cardiovascular disease, stroke, Alzheimer disease, cataracts, and some of the functional declines associated with aging. Prevention is a more effective strategy than is treatment of chronic diseases. Functional foods that contain significant amounts of bioactive components may provide desirable health benefits beyond basic nutrition and play important roles in the prevention of chronic diseases. The key question is whether a purified phytochemical has the same health benefit as does the whole food or mixture of foods in which the phytochemical is present. Our group found, for example, that the vitamin C in apples with skin accounts for only 0.4% of the total antioxidant activity, suggesting that most of the antioxidant activity of fruit and vegetables may come from phenolics and flavonoids in apples. We propose that the additive and synergistic effects of phytochemicals in fruit and vegetables are responsible for their potent antioxidant and anticancer activities, and that the benefit of a diet rich in fruit and vegetables is attributed to the complex mixture of phytochemicals present in whole foods.

  12. Clinical imaging guidelines part 2: Risks, benefits, barriers, and solutions.

    PubMed

    Malone, James; del Rosario-Perez, Maria; Van Bladel, Lodewijk; Jung, Seung Eun; Holmberg, Ola; Bettmann, Michael A

    2015-02-01

    A recent international meeting was convened by two United Nations bodies to focus on international collaboration on clinical appropriateness/referral guidelines for use in medical imaging. This paper, the second of 4 from this technical meeting, addresses barriers to the successful development/deployment of clinical imaging guidelines and means of overcoming them. It reflects the discussions of the attendees, and the issues identified are treated under 7 headings: ■ Practical Strategy for Development and Deployment of Guidelines; ■ Governance Arrangements and Concerns with Deployment of Guidelines; ■ Finance, Sustainability, Reimbursement, and Related Issues; ■ Identifying Benefits and Radiation Risks from Radiological Examinations; ■ Information Given to Patients and the Public, and Consent Issues; ■ Special Concerns Related to Pregnancy; and ■ The Research Agenda. Examples of topics identified include the observation that guideline development is a global task and there is no case for continuing it as the project of the few professional organizations that have been brave enough to make the long-term commitment required. Advocacy for guidelines should include the expectations that they will facilitate: (1) better health care delivery; (2) lower cost of that delivery; with (3) reduced radiation dose and associated health risks. Radiation protection issues should not be isolated; rather, they should be integrated with the overall health care picture. The type of dose/radiation risk information to be provided with guidelines should include the uncertainty involved and advice on application of the precautionary principle with patients. This principle may be taken as an extension of the well-established medical principle of "first do no harm." PMID:25652302

  13. A laboratory study of the perceived benefit of additional noise attenuation by houses

    NASA Technical Reports Server (NTRS)

    Flindell, I. H.

    1983-01-01

    Two Experiments were conducted to investigate the perceived benefit of additional house attenuation against aircraft flyover noise. First, subjects made annoyance judgments in a simulated living room while an operative window with real and dummy storm windows was manipulated in full view of those subjects. Second, subjects made annoyance judgments in an anechoic audiometric test chamber of frequency shaped noise signals having spectra closely matched to those of the aircraft flyover noises reproduced in the first experiment. These stimuli represented the aircraft flyover noises in levels and spectra but without the situational and visual cues present in the simulated living room. Perceptual constancy theory implies that annoyance tends to remain constant despite reductions in noise level caused by additional attenuation of which the subjects are fully aware. This theory was supported when account was taken for a reported annoyance overestimation for certain spectra and for a simulated condition cue overreaction.

  14. A laboratory study of the perceived benefit of additional noise attenuation by houses

    NASA Astrophysics Data System (ADS)

    Flindell, I. H.

    1983-06-01

    Two Experiments were conducted to investigate the perceived benefit of additional house attenuation against aircraft flyover noise. First, subjects made annoyance judgments in a simulated living room while an operative window with real and dummy storm windows was manipulated in full view of those subjects. Second, subjects made annoyance judgments in an anechoic audiometric test chamber of frequency shaped noise signals having spectra closely matched to those of the aircraft flyover noises reproduced in the first experiment. These stimuli represented the aircraft flyover noises in levels and spectra but without the situational and visual cues present in the simulated living room. Perceptual constancy theory implies that annoyance tends to remain constant despite reductions in noise level caused by additional attenuation of which the subjects are fully aware. This theory was supported when account was taken for a reported annoyance overestimation for certain spectra and for a simulated condition cue overreaction.

  15. Addition of Rice Bran Arabinoxylan to Curcumin Therapy May Be of Benefit to Patients With Early-Stage B-Cell Lymphoid Malignancies (Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Stage 0/1 Chronic Lymphocytic Leukemia): A Preliminary Clinical Study.

    PubMed

    Golombick, Terry; Diamond, Terrence H; Manoharan, Arumugam; Ramakrishna, Rajeev

    2016-06-01

    Hypothesis Prior studies on patients with early B-cell lymphoid malignancies suggest that early intervention with curcumin may lead to delay in progressive disease and prolonged survival. These patients are characterized by increased susceptibility to infections. Rice bran arabinoxylan (Ribraxx) has been shown to have immunostimulatory, anti-inflammatory, and proapoptotic effects. We postulated that addition of Ribraxx to curcumin therapy may be of benefit. Study design Monoclonal gammopathy of undetermined significance (MGUS)/smoldering multiple myeloma (SMM) or stage 0/1 chronic lymphocytic leukemia (CLL) patients who had been on oral curcumin therapy for a period of 6 months or more were administered both curcumin (as Curcuforte) and Ribraxx. Methods Ten MGUS/SMM patients and 10 patients with stage 0/1 CLL were administered 6 g of curcumin and 2 g Ribraxx daily. Blood samples were collected at baseline and at 2-month intervals for a period of 6 months, and various markers were monitored. MGUS/SMM patients included full blood count (FBC); paraprotein; free light chains/ratio; C-reactive protein (CRP)and erythrocyte sedimentation rate (ESR); B2 microglobulin and immunological markers. Markers monitored for stage 0/1 CLL were FBC, CRP and ESR, and immunological markers. Results Of 10 MGUS/SMM patients,5 (50%) were neutropenic at baseline, and the Curcuforte/Ribraxx combination therapy showed an increased neutrophil count, varying between 10% and 90% among 8 of the 10 (80%) MGUS/SMM patients. An additional benefit of the combination therapy was the potent effect in reducing the raised ESR in 4 (44%) of the MGUS/SMM patients. Conclusion Addition of Ribraxx to curcumin therapy may be of benefit to patients with early-stage B-cell lymphoid malignancies. PMID:27154182

  16. Analysis of the benefits of carbon credits to hydrogen addition to midsize gas turbine feedstocks.

    SciTech Connect

    Miller, J.; Towns, B.; Keller, Jay O.; Schefer, Robert W.; Skolnik, Edward G.

    2006-02-01

    The addition of hydrogen to the natural gas feedstocks of midsize (30-150 MW) gas turbines was analyzed as a method of reducing nitrogen oxides (NO{sub x}) and CO{sub 2} emissions. In particular, the costs of hydrogen addition were evaluated against the combined costs for other current NO{sub x} and CO{sub 2} emissions control technologies for both existing and new systems to determine its benefits and market feasibility. Markets for NO{sub x} emissions credits currently exist in California and the Northeast States and are expected to grow. Although regulations are not currently in place in the United States, several other countries have implemented carbon tax and carbon credit programs. The analysis thus assumes that the United States adopts future legislation similar to these programs. Therefore, potential sale of emissions credits for volunteer retrofits was also included in the study. It was found that hydrogen addition is a competitive alternative to traditional emissions abatement techniques under certain conditions. The existence of carbon credits shifts the system economics in favor of hydrogen addition.

  17. 42 CFR 408.21 - Reduction in Medicare Part B premium as an additional benefit under Medicare+Choice plans.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 2 2011-10-01 2011-10-01 false Reduction in Medicare Part B premium as an additional benefit under Medicare+Choice plans. 408.21 Section 408.21 Public Health CENTERS FOR MEDICARE... additional benefit under Medicare+Choice plans. (a) Basis for reduction in Part B premium. Beginning...

  18. 42 CFR 408.21 - Reduction in Medicare Part B premium as an additional benefit under Medicare+Choice plans.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Reduction in Medicare Part B premium as an additional benefit under Medicare+Choice plans. 408.21 Section 408.21 Public Health CENTERS FOR MEDICARE... additional benefit under Medicare+Choice plans. (a) Basis for reduction in Part B premium. Beginning...

  19. Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

    PubMed

    Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

    2015-12-01

    The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

  20. Application of the CIT concept in the clinical environment: hurdles, practicalities, and clinical benefits.

    PubMed

    Sterr, Annette; Szameitat, Andre; Shen, Shan; Freivogel, Susanna

    2006-03-01

    Basic neuroscience research on brain plasticity, motor learning, and recovery has stimulated new concepts in motor rehabilitation. Combined with the development of methodological goal standards in clinical outcome research, these findings have effectuated the introduction of a double-paradigm shift in physical rehabilitation: (a) the move toward evidence-based procedures and disablement models for the assessment of clinical outcome and (b) the introduction of training-based concepts that are theoretically founded in learning theory. A major drive for new interventions has further come from recent findings on the adaptive capacities of neural networks and their linkage to perception, performance, and long-term recovery. In this context, constraint-induced movement therapy, an intervention initially designed for upper-limb hemiparesis, represents the theoretically and empirically most thoroughly founded training concept. Several clinical trials on constraint-induced therapy (CIT) have shown its efficacy in higher functioning patients; however, the transfer of the treatment into standard health care seems slow. Survey research further suggests a rather poor acceptance of CIT among clinical staff and it seems that the implementation of CIT is hindered by barriers constructed of beliefs and assumptions that demand a critical and evidence-based discussion. Within this context, we have conducted a series of experiments on amended CIT protocols and their application in the clinical environment which addressed the following issues: (1) massed practice: are 6 hours of daily training inevitable to achieve clinical benefits? (2) practicality: what is feasible in the standard care setting and what are the clinical benefits achieved by "feasible compromise CIT protocols?" (3) apprehensions: are concerns on increased muscular tone and pathologic movement patterns justified, and (4) learned nonuse: is the assumption of "hidden" residual abilities valid so that it warrants the

  1. Charcoal addition to soils in NE England: a carbon sink with environmental co-benefits?

    PubMed

    Bell, M J; Worrall, F

    2011-04-01

    Interest in the application of biochar (charcoal produced during the pyrolysis of biomass) to agricultural land is increasing across the world, recognised as a potential way to capture and store atmospheric carbon. Its interest is heightened by its potential co-benefits for soil quality and fertility. The majority of research has however been undertaken in tropical rather than temperate regions. This study assessed the potential for lump-wood charcoal addition (as a substitute for biochar) to soil types which are typically under arable and forest land-use in North East England. The study was undertaken over a 28 week period and found: i) No significant difference in net ecosystem respiration (NER) between soils containing charcoal and those without, other than in week 1 of the trial. ii) A significantly higher dissolved organic carbon (DOC) flux from soils containing large amounts of charcoal than from those untreated, when planted with ryegrass. iii) That when increased respiration or DOC loss did occur, neither was sufficiently large to alter the carbon sink benefits of charcoal application. iv) That charcoal incorporation resulted in a significantly lower nitrate flux in soil leachate from mineral soils. v) That charcoal incorporation caused significant increases in soil pH, from 6.98 to 7.22 on bare arable soils when 87,500 kg charcoal/ha was applied. Consideration of both the carbon sink and environmental benefits observed here suggests that charcoal application to temperate soils typical of North East England should be considered as a method of carbon sequestration. Before large scale land application is encouraged, further large scale trials should be undertaken to confirm the positive results of this research.

  2. A Pilot Test of the Additive Benefits of Physical Exercise to CBT for OCD.

    PubMed

    Rector, Neil A; Richter, Margaret A; Lerman, Bethany; Regev, Rotem

    2015-01-01

    The majority of "responders" to first-line cognitive-behavioural therapy (CBT) and pharmacological treatments for obsessive-compulsive disorder (OCD) are left with residual symptoms that are clinically relevant and disabling. Therefore, there is pressing need for widely accessible efficacious alternative and/or adjunctive treatments for OCD. Accumulating evidence suggests that physical exercise may be one such intervention in the mood and anxiety disorders broadly, although we are aware of only two positive small-scale pilot studies that have tested its clinical benefits in OCD. This pilot study aimed to test the feasibility and preliminary efficacy of adding a structured physical exercise programme to CBT for OCD. A standard CBT group was delivered concurrently with a 12-week customized exercise programme to 11 participants. The exercise regimen was individualized for each participant based on peak heart rate measured using an incremental maximal exercise test. Reports of exercise adherence across the 12-week regimen exceeded 80%. A paired-samples t-test indicated very large treatment effects in Yale-Brown Obsessive-Compulsive Scale scores from pre- to post-treatment in CBT group cohorts led by expert CBT OCD specialists (d = 2.55) and junior CBT clinician non-OCD specialists (d = 2.12). These treatment effects are very large and exceed effects typically observed with individual and group-based CBT for OCD based on leading meta-analytic reviews, as well as previously obtained treatment effects for CBT using the same recruitment protocol without exercise. As such, this pilot work demonstrates the feasibility and significant potential clinical utility of a 12-week aerobic exercise programme delivered in conjunction with CBT for OCD. PMID:25738234

  3. A Pilot Test of the Additive Benefits of Physical Exercise to CBT for OCD.

    PubMed

    Rector, Neil A; Richter, Margaret A; Lerman, Bethany; Regev, Rotem

    2015-01-01

    The majority of "responders" to first-line cognitive-behavioural therapy (CBT) and pharmacological treatments for obsessive-compulsive disorder (OCD) are left with residual symptoms that are clinically relevant and disabling. Therefore, there is pressing need for widely accessible efficacious alternative and/or adjunctive treatments for OCD. Accumulating evidence suggests that physical exercise may be one such intervention in the mood and anxiety disorders broadly, although we are aware of only two positive small-scale pilot studies that have tested its clinical benefits in OCD. This pilot study aimed to test the feasibility and preliminary efficacy of adding a structured physical exercise programme to CBT for OCD. A standard CBT group was delivered concurrently with a 12-week customized exercise programme to 11 participants. The exercise regimen was individualized for each participant based on peak heart rate measured using an incremental maximal exercise test. Reports of exercise adherence across the 12-week regimen exceeded 80%. A paired-samples t-test indicated very large treatment effects in Yale-Brown Obsessive-Compulsive Scale scores from pre- to post-treatment in CBT group cohorts led by expert CBT OCD specialists (d = 2.55) and junior CBT clinician non-OCD specialists (d = 2.12). These treatment effects are very large and exceed effects typically observed with individual and group-based CBT for OCD based on leading meta-analytic reviews, as well as previously obtained treatment effects for CBT using the same recruitment protocol without exercise. As such, this pilot work demonstrates the feasibility and significant potential clinical utility of a 12-week aerobic exercise programme delivered in conjunction with CBT for OCD.

  4. Estimating the clinical benefits of vaccinating boys and girls against HPV-related diseases in Europe

    PubMed Central

    2013-01-01

    Background HPV is related to a number of cancer types, causing a considerable burden in both genders in Europe. Female vaccination programs can substantially reduce the incidence of HPV-related diseases in women and, to some extent, men through herd immunity. The objective was to estimate the incremental benefit of vaccinating boys and girls using the quadrivalent HPV vaccine in Europe versus girls-only vaccination. Incremental benefits in terms of reduction in the incidence of HPV 6, 11, 16 and 18-related diseases (including cervical, vaginal, vulvar, anal, penile, and head and neck carcinomas and genital warts) were assessed. Methods The analysis was performed using a model constructed in Microsoft®Excel, based on a previously-published dynamic transmission model of HPV vaccination and published European epidemiological data on incidence of HPV-related diseases. The incremental benefits of vaccinating 12-year old girls and boys versus girls-only vaccination was assessed (70% vaccine coverage were assumed for both). Sensitivity analyses around vaccine coverage and duration of protection were performed. Results Compared with screening alone, girls-only vaccination led to 84% reduction in HPV 16/18-related carcinomas in females and a 61% reduction in males. Vaccination of girls and boys led to a 90% reduction in HPV 16/18-related carcinomas in females and 86% reduction in males versus screening alone. Relative to a girls-only program, vaccination of girls and boys led to a reduction in female and male HPV-related carcinomas of 40% and 65%, respectively and a reduction in the incidence of HPV 6/11-related genital warts of 58% for females and 71% for males versus girls-only vaccination. Conclusions In Europe, the vaccination of 12-year old boys and girls against HPV 6, 11, 16 and 18 would be associated with substantial additional clinical benefits in terms of reduced incidence of HPV-related genital warts and carcinomas versus girls-only vaccination. The incremental

  5. Analyzing the blood-brain barrier: the benefits of medical imaging in research and clinical practice.

    PubMed

    Chassidim, Yoash; Vazana, Udi; Prager, Ofer; Veksler, Ronel; Bar-Klein, Guy; Schoknecht, Karl; Fassler, Michael; Lublinsky, Svetlana; Shelef, Ilan

    2015-02-01

    A dysfunctional BBB is a common feature in a variety of brain disorders, a fact stressing the need for diagnostic tools designed to assess brain vessels' permeability in space and time. Biological research has benefited over the years various means to analyze BBB integrity. The use of biomarkers for improper BBB functionality is abundant. Systemic administration of BBB impermeable tracers can both visualize brain regions characterized by BBB impairment, as well as lead to its quantification. Additionally, locating molecular, physiological content in regions from which it is restricted under normal BBB functionality undoubtedly indicates brain pathology-related BBB disruption. However, in-depth research into the BBB's phenotype demands higher analytical complexity than functional vs. pathological BBB; criteria which biomarker based BBB permeability analyses do not meet. The involvement of accurate and engineering sciences in recent brain research, has led to improvements in the field, in the form of more accurate, sensitive imaging-based methods. Improvements in the spatiotemporal resolution of many imaging modalities and in image processing techniques, make up for the inadequacies of biomarker based analyses. In pre-clinical research, imaging approaches involving invasive procedures, enable microscopic evaluation of BBB integrity, and benefit high levels of sensitivity and accuracy. However, invasive techniques may alter normal physiological function, thus generating a modality-based impact on vessel's permeability, which needs to be corrected for. Non-invasive approaches do not affect proper functionality of the inspected system, but lack in spatiotemporal resolution. Nevertheless, the benefit of medical imaging, even in pre-clinical phases, outweighs its disadvantages. The innovations in pre-clinical imaging and the development of novel processing techniques, have led to their implementation in clinical use as well. Specialized analyses of vessels' permeability

  6. Apoptosis inhibitors and mini-agrin have additive benefits in congenital muscular dystrophy mice

    PubMed Central

    Meinen, Sarina; Lin, Shuo; Thurnherr, Raphael; Erb, Michael; Meier, Thomas; Rüegg, Markus A

    2011-01-01

    Mutations in LAMA2 cause a severe form of congenital muscular dystrophy, called MDC1A. Studies in mouse models have shown that transgenic expression of a designed, miniaturized form of the extracellular matrix molecule agrin (‘mini-agrin’) or apoptosis inhibition by either overexpression of Bcl2 or application of the pharmacological substance omigapil can ameliorate the disease. Here, we tested whether mini-agrin and anti-apoptotic agents act on different pathways and thus exert additive benefits in MDC1A mouse models. By combining mini-agrin with either transgenic Bcl2 expression or oral omigapil application, we show that the ameliorating effect of mini-agrin, which acts by restoring the mechanical stability of muscle fibres and, thereby, reduces muscle fibre breakdown and concomitant fibrosis, is complemented by apoptosis inhibitors, which prevent the loss of muscle fibres. Treatment of mice with both agents results in improved muscle regeneration and increased force. Our results show that the combination of mini-agrin and anti-apoptosis treatment has beneficial effects that are significantly bigger than the individual treatments and suggest that such a strategy might also be applicable to MDC1A patients. PMID:21674808

  7. Trends in compensation and benefits provided to physical therapy students during clinical education.

    PubMed

    Kondela, P M; Darnell, R E

    1979-10-01

    Many facilities offering physical therapy clinical education for full-time affiliation students also provide some sort of compensation or benefits to students. Fiscal policy trends within health care institutions have influenced the extent to which these benefits are provided. The purpose of this study was to examine trends in providing specific benefits, namely, stipend, housing, meals, and uniform laundry, to students in full-time clinical education at the University of Michigan from 1967 to 1977. Data from annual facility information forms showed that, in general, these benefits have decreased during the years examined. PMID:493344

  8. Couples Counseling in Alzheimer's Disease: Additional Clinical Findings from a Novel Intervention Study.

    PubMed

    Auclair, Ursula; Epstein, Cynthia; Mittelman, Mary

    2009-04-01

    This article describes the clinical findings of a study designed to assess the benefit of counseling for couples, one of whom is in the early stage of Alzheimer's disease (AD). We previously reported our findings based on the first 12 couples that enrolled in the study. Based on the treatment of 30 additional couples, we have refined our treatment strategy to include concepts of Gestalt Therapy and Transactional Analysis and identified prevalent issues of concern to this cohort. The study design has remained as described in the earlier article (Epstein et al., 2006), and has proven to be appropriate to meet the goals of this intervention as indicated by our clinical experience and feedback from the participating couples. Case vignettes demonstrate how to conduct the sessions so that the experience of each member of the dyad is validated, while acknowledging the differential impact of the disease on them. PMID:19865591

  9. Clinical benefits of diffusion tensor imaging in hydrocephalus.

    PubMed

    Ben-Sira, Liat; Goder, Noam; Bassan, Haim; Lifshits, Shlomi; Assaf, Yaniv; Constantini, Shlomi

    2015-08-01

    OBJECT The object of this study was to use diffusion tensor imaging (DTI) to evaluate and characterize white matter changes in hydrocephalus. METHODS The authors performed a retrospective analysis of DTI in a cohort of patients with hydrocephalus (n = 35), 19 of whom had both pre- and postsurgical imaging studies. These patient's DTI values were compared with values extracted from age-dependent trend lines computed from a healthy subject group (n = 70, age span 14 months-14 years). Several DTI parameters in different regions of interest (ROIs) were evaluated to find the most sensitive parameters for clinical decision making in hydrocephalus. RESULTS Compared with healthy controls, patients with active hydrocephalus had a statistically significant change in all DTI parameters. The most sensitive and specific DTI parameter for predicting hydrocephalus was axial diffusivity (λ1) measured at the level of the corona radiata. Diffusion tensor imaging parameters correlated with several conventional radiological parameters in the assessment of hydrocephalus but were not superior to them. There was no convincing correlation between clinical disease severity and DTI parameters. When examining the pre- and postsurgical effect, it was found that DTI may be a sensitive tool for estimating tissue improvement. CONCLUSIONS This large-cohort study with a multidisciplinary approach combining clinical, neurological, radiological, and multiple DTI parameters revealed the most sensitive DTI parameters for identifying hydrocephalus and suggested that they may serve as an important tool for the disorder's quantitative radiological assessment.

  10. 20 CFR 725.309 - Additional claims; effect of a prior denial of benefits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (see § 725.4(d)), a person may exercise the right of review provided in paragraph (c) of § 727.103 at..., DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED CLAIMS FOR BENEFITS UNDER PART C OF TITLE IV OF THE FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED Filing of Claims §...

  11. 20 CFR 725.309 - Additional claims; effect of a prior denial of benefits.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (see § 725.4(d)), a person may exercise the right of review provided in paragraph (c) of § 727.103 at..., DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED CLAIMS FOR BENEFITS UNDER PART C OF TITLE IV OF THE FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED Filing of Claims §...

  12. 42 CFR 417.442 - Risk HMO's and CMP's: Conditions for provision of additional benefits.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ....440(b)(4) if its ACRs (calculated in accordance with § 417.594) are less than the average per capita... benefits and reduced payment is equivalent to the difference between the average of its per capita rates of...— (i) Elects to receive reduced payment so that there is no difference between the average of its...

  13. 42 CFR 417.442 - Risk HMO's and CMP's: Conditions for provision of additional benefits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ....440(b)(4) if its ACRs (calculated in accordance with § 417.594) are less than the average per capita... benefits and reduced payment is equivalent to the difference between the average of its per capita rates of...— (i) Elects to receive reduced payment so that there is no difference between the average of its...

  14. 42 CFR 417.442 - Risk HMO's and CMP's: Conditions for provision of additional benefits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ....440(b)(4) if its ACRs (calculated in accordance with § 417.594) are less than the average per capita... benefits and reduced payment is equivalent to the difference between the average of its per capita rates of...— (i) Elects to receive reduced payment so that there is no difference between the average of its...

  15. No clinical benefit of gender-specific total knee arthroplasty

    PubMed Central

    Zhu, Chen; Wang, Jiaxing; Cheng, Mengqi; Peng, Xiaochun; Wang, Qi; Zhang, Xianlong

    2014-01-01

    Background and purpose There is no consensus regarding the clinical relevance of gender-specific prostheses in total knee arthroplasty (TKA). We summarize the current best evidence in a comparison of clinical and radiographic outcomes between gender-specific prostheses and standard unisex prostheses in female patients. Methods We used the PubMed, Embase, Cochrane, Science Citation Index, and Scopus databases. We included randomized controlled trials published up to January 2013 that compared gender-specific prostheses with standard unisex prostheses in female patients who underwent primary TKAs. Results 6 trials involving 423 patients with 846 knee joints met the inclusion criteria. No statistically significant differences were observed between the 2 designs regarding pain, range of motion (ROM), knee scores, satisfaction, preference, complications, and radiographic results. The gender-specific design (Gender Solutions; Zimmer Inc, Warsaw, Indiana) reduced the prevalence of overhang. However, it had less overall coverage of the femoral condyles compared to the unisex group. In fact, the femoral prosthesis in the standard unisex group matched better than that in the gender-specific group. Interpretation Gender-specific prostheses do not appear to confer any benefit in terms of clinician- and patient-reported outcomes for the female knee. PMID:24954488

  16. Blood culture series benefit may be limited to selected clinical conditions: time to reassess.

    PubMed

    Khatib, R; Simeunovic, G; Sharma, M; Fakih, M G; Johnson, L B; Briski, L; Lebar, W

    2015-04-01

    Blood cultures are often submitted as series (two to three sets per 24 hours) to maximize sample recovery. We assessed the actual benefit of additional sets. Blood cultures submitted from adults (≥ 18 years old) over 1 year (1 February 2012 to 31 January 2013) were examined. The medical records of patients with positive cultures were reviewed. Cultures with commensal organisms were considered contamination in the absence of a source and clinical findings. The impact of additional sets on antibiotic therapy was estimated. We evaluated 15,394 blood cultures. They were submitted as two to five sets per 24 hours in 12,236 (79.5%) instances. Pathogens were detected in 1227 sets, representing 741 bacteremias, of which 618 (83.4%) were detected in the first set and 123 (16.6%) in the additional sets. Pathogens missed in the first set were recovered from patients receiving antibiotics (n = 72; 58.5%) and after undergoing a procedure (n = 54; 43.9%). The additional sets' results could have influenced antibiotic therapy in 76/6235 (1.2%) instances, including 40 (0.6%) antibiotic switches and 36 (0.6%) possible extensions of therapy. The potential impact of the detection of missed pathogens on antibiotic therapy was not apparent in patients who had an endovascular infection (26/27, 96.3%) and those who lacked an obvious source of pathogens (10/10, 100%). These findings suggest that one blood culture is probably adequate in patients with an obvious source of pathogens. Blood culture series are beneficial in patients without an obvious source of pathogens and in those with endovascular infections. It is time to reassess the benefit of blood culture series, perhaps limiting them to selected conditions.

  17. Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors.

    PubMed

    Kirkham, Amy A; Bland, Kelcey A; Sayyari, Sarah; Campbell, Kristin L; Davis, Margot K

    2016-02-01

    Evidence is currently limited for the effect of exercise on breast cancer clinical outcomes. However, several of the reported physical benefits of exercise, including peak oxygen consumption, functional capacity, muscle strength and lean mass, cardiovascular risk factors, and bone health, have established associations with disability, cardiovascular disease risk, morbidity, and mortality. This review will summarize the clinically relevant physical benefits of exercise interventions in breast cancer survivors and discuss recommendations for achieving these benefits. It will also describe potential differences in intervention delivery that may impact outcomes and, lastly, describe current physical activity guidelines for cancer survivors. PMID:26769117

  18. Decision theory and the evaluation of risks and benefits of clinical trials.

    PubMed

    Bernabe, Rosemarie D C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M

    2012-12-01

    Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making. PMID:22819925

  19. Revisiting the Dialogue on the Transition from Coteaching to Inservice Teaching: New Frameworks, Additional Benefits and Emergent Issues

    ERIC Educational Resources Information Center

    Wassell, Beth; LaVan, Sarah Kate

    2009-01-01

    In this rejoinder, we respond to the major points made by Gallo-Fox (this forum), Beers (this forum), Carambo and Stickney (this forum), and Murphy, Carlisle and Beggs (this forum). We focus primarily on the benefits and considerations that stem from employing additional theoretical frameworks for analyzing research in coteaching. We also address…

  20. Additives

    NASA Technical Reports Server (NTRS)

    Smalheer, C. V.

    1973-01-01

    The chemistry of lubricant additives is discussed to show what the additives are chemically and what functions they perform in the lubrication of various kinds of equipment. Current theories regarding the mode of action of lubricant additives are presented. The additive groups discussed include the following: (1) detergents and dispersants, (2) corrosion inhibitors, (3) antioxidants, (4) viscosity index improvers, (5) pour point depressants, and (6) antifouling agents.

  1. Review of the Additional Support for Learning Act: "Adding Benefits for Learners"

    ERIC Educational Resources Information Center

    Her Majesty's Inspectorate of Education, 2010

    2010-01-01

    In May 2009, the Minister for Children and Early Years, gave a commitment to Parliament to establish a working group to report on how the "Education (Additional Support for Learning) (Scotland) Act 2004" (the Act) is affecting children and young people who: (1) are looked after; (2) are young carers; (3) have mental health disorders; and (4) have…

  2. Dipeptidyl peptidase-4 inhibitors and the ischemic heart: Additional benefits beyond glycemic control.

    PubMed

    Chattipakorn, Nipon; Apaijai, Nattayaporn; Chattipakorn, Siriporn C

    2016-01-01

    Obese-insulin resistance and type 2 diabetes mellitus (T2DM) have become global health problems, and they are both associated with a higher risk of ischemic heart disease. Although reperfusion therapy is the treatment to increase blood supply to the ischemic myocardium, this intervention potentially causes cardiac tissue damage and instigates arrhythmias, processes known as reperfusion injury. Dipeptidyl peptidase 4 (DPP-4) inhibitors are glycemic control drugs commonly used in T2DM patients. Growing evidence from basic and clinical studies demonstrates that a DPP-4 inhibitor could exert cardioprotection and improve left ventricular function by reducing oxidative stress, apoptosis, and increasing reperfusion injury salvage kinase (RISK) activity. However, recent reports also showed potentially adverse cardiac events due to the use of a DPP-4 inhibitor. To investigate this disparity, future large clinical trials are essential in verifying whether DPP-4 inhibitors are beneficial beyond their glycemic control particularly for the ischemic heart in obese-insulin resistant subjects and T2DM patients.

  3. News Note: Addition of drug to standard chemo for prostate cancer shows no benefit

    Cancer.gov

    Prostate cancer patients in a phase 3 trial who were non-responsive to hormone therapy and received the investigational agent atrasentan in addition to a standard chemotherapy regimen, did not have longer survival or longer progression-free survival compared to the patients on the same chemotherapy regimen and a placebo. This determination was made by the trial’s Data and Safety Monitoring Committee (DSMC) based on a planned interim analysis of the trial.

  4. Benefits of neutral electrolyzed oxidizing water as a drinking water additive for broiler chickens.

    PubMed

    Bügener, E; Kump, A Wilms-Schulze; Casteel, M; Klein, G

    2014-09-01

    In the wake of discussion about the use of drugs in food-producing farms, it seems to be more and more important to search for alternatives and supportive measures to improve health. In this field trial, the influence of electrolyzed oxidizing (EO) water on water quality, drug consumption, mortality, and performance parameters such as BW and feed conversion rate was investigated on 2 broiler farms. At each farm, 3 rearing periods were included in the study. With EO water as the water additive, the total viable cell count and the number of Escherichia coli in drinking water samples were reduced compared with the respective control group. The frequency of treatment days was represented by the number of used daily doses per population and showed lower values in EO-water-treated groups at both farms. Furthermore, the addition of EO water resulted in a lower mortality rate. In terms of analyzed performance parameters, no significant differences were determined. In this study, the use of EO water improved drinking water quality and seemed to reduce the drug use without showing negative effects on performance parameters and mortality rates. PMID:25037820

  5. Benefits of neutral electrolyzed oxidizing water as a drinking water additive for broiler chickens.

    PubMed

    Bügener, E; Kump, A Wilms-Schulze; Casteel, M; Klein, G

    2014-09-01

    In the wake of discussion about the use of drugs in food-producing farms, it seems to be more and more important to search for alternatives and supportive measures to improve health. In this field trial, the influence of electrolyzed oxidizing (EO) water on water quality, drug consumption, mortality, and performance parameters such as BW and feed conversion rate was investigated on 2 broiler farms. At each farm, 3 rearing periods were included in the study. With EO water as the water additive, the total viable cell count and the number of Escherichia coli in drinking water samples were reduced compared with the respective control group. The frequency of treatment days was represented by the number of used daily doses per population and showed lower values in EO-water-treated groups at both farms. Furthermore, the addition of EO water resulted in a lower mortality rate. In terms of analyzed performance parameters, no significant differences were determined. In this study, the use of EO water improved drinking water quality and seemed to reduce the drug use without showing negative effects on performance parameters and mortality rates.

  6. Clinical Benefits of Memantine Treatment for Alzheimer's Disease in the Okayama Memantine Study II (OMS II).

    PubMed

    Matsuzono, Kosuke; Yamashita, Toru; Ohta, Yasuyuki; Hishikawa, Nozomi; Koike, Makoto; Sato, Kota; Kono, Syoichiro; Deguchi, Kentaro; Nakano, Yumiko; Abe, Koji

    2015-01-01

    The clinical benefits of memantine, depending on the baseline cognitive and affective conditions in real world dementia clinics, have not been completely examined. We performed the "Okayama Memantine Study II (OMS II)" to retrospectively evaluate the clinical effects of memantine monotherapy (n = 38) in Alzheimer's disease (AD) patients using seven batteries to assess dementia at the baseline, at 3, 6, and 12 months. Additionally, we divided 163 AD patients treated with memantine into two subgroups depending on the baseline cognitive score of the Mini-Mental State Examination (MMSE): the MMSE <15 group (n = 36) and the baseline MMSE ≥15 group (n = 127). We also analyzed 71 AD patients based on the baseline behavioral and psychological symptoms of dementia (BPSD) severity using Abe's BPSD score (ABS). Memantine monotherapy maintained cognitive functions until 6 months of treatment, but showed a decrease at 12 months ( *p <  0.05 versus baseline). However, memantine monotherapy greatly improved BPSD symptoms until 12 months ( *p <  0.05,  **p <  0.01) and maintained other affective functions as well as the activity of daily living. Memantine treatment showed similar effects, regardless of the baseline cognitive functions, but showed better effects on ABS for higher baseline cognitive functions. Memantine treatment greatly improved ABS depending on baseline BPSD severity. Our present OMS II showed that memantine monotherapy improved BPSD until 12 months. The higher baseline cognitive subgroup (MMSE ≥15) and the worse baseline BPSD subgroup were expected to show better effects with memantine.

  7. Probiotics as Additives on Therapy in Allergic Airway Diseases: A Systematic Review of Benefits and Risks

    PubMed Central

    Das, Rashmi Ranjan; Naik, Sushree Samiksha; Singh, Meenu

    2013-01-01

    Background. We conducted a systematic review to find out the role of probiotics in treatment of allergic airway diseases.  Methods. A comprehensive search of the major electronic databases was done till March 2013. Trials comparing the effect of probiotics versus placebo were included. A predefined set of outcome measures were assessed. Continuous data were expressed as standardized mean difference with 95% CI. Dichotomous data were expressed as odds ratio with 95% CI. P value < 0.05 was considered as significant. Results. A total of 12 studies were included. Probiotic intake was associated with a significantly improved quality of life score in patients with allergic rhinitis (SMD −1.9 (95% CI −3.62, −0.19); P = 0.03), though there was a high degree of heterogeneity. No improvement in quality of life score was noted in asthmatics. Probiotic intake also improved the following parameters: longer time free from episodes of asthma and rhinitis and decrease in the number of episodes of rhinitis per year. Adverse events were not significant. Conclusion. As the current evidence was generated from few trials with high degree of heterogeneity, routine use of probiotics as an additive on therapy in subjects with allergic airway diseases cannot be recommended. PMID:23956972

  8. Additive benefits of autonomy support and enhanced expectancies for motor learning.

    PubMed

    Wulf, Gabriele; Chiviacowsky, Suzete; Cardozo, Priscila Lopes

    2014-10-01

    Two factors that have been shown to facilitate motor learning are autonomy support (AS) and enhanced expectancies (EE) for performance. We examined the individual and combined influences of these factors. In a 2 × 2 design, participants learning a novel motor skill (throwing with the non-dominant arm) were or were not provided a choice (AS) about the ball color on each of 6 10-trial blocks during practice, and were or were not given bogus positive social-comparative feedback (EE). This resulted in four groups: AS/EE, AS, EE, and C (control). One day after the practice phase, participants completed 10 retention and 10 transfer trials. The distance to the target--a bull's eye with a 1m radius and 10 concentric circles--was 7.5m during practice and retention, and 8.5m during transfer. Autonomy support and enhanced expectancies had additive advantages for learning, with both main effects being significant for retention and transfer. On both tests, the AS/EE group showed the greatest throwing accuracy. Also, the accuracy scores of the AS and EE groups were higher than those of the C group. Furthermore, self-efficacy measured after practice and before retention and transfer was increased by both AS and EE. Thus, supporting learners' need for autonomy by given them a small choice--even though it was not directly related to task performance--and enhancing their performance expectancies appeared to independently influence learning.

  9. The intelligent use and clinical benefits of electronic medical records in multiple sclerosis

    PubMed Central

    Davis, Mary F.

    2015-01-01

    Summary Electronic medical records (EMRs) are being quickly adopted in clinics around the world. This advancement can greatly enhance the clinical care of patients with multiple sclerosis (MS) by providing formats that allow easier review of medical documents and more structured avenues to store relevant information. MS clinicians should be involved with implementing and updating EMRs at their institutions to ensure EMR formats that benefit MS clinics. EMRs also provide opportunities for research studies of MS to access detailed, longitudinal data of MS disease course that would otherwise be difficult to collect. PMID:25495075

  10. The intelligent use and clinical benefits of electronic medical records in multiple sclerosis.

    PubMed

    Davis, Mary F; Haines, Jonathan L

    2015-02-01

    Electronic medical records (EMRs) are being quickly adopted in clinics around the world. This advancement can greatly enhance the clinical care of patients with multiple sclerosis (MS) by providing formats that allow easier review of medical documents and more structured avenues to store relevant information. MS clinicians should be involved with implementing and updating EMRs at their institutions to ensure EMR formats that benefit MS clinics. EMRs also provide opportunities for research studies of MS to access detailed, longitudinal data of MS disease course that would otherwise be difficult to collect. PMID:25495075

  11. Harms, benefits, and the nature of interventions in pragmatic clinical trials.

    PubMed

    Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

    2015-10-01

    To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems.

  12. Nutritional, Health, and Technological Functionality of Lupin Flour Addition to Bread and Other Baked Products: Benefits and Challenges.

    PubMed

    Villarino, C B J; Jayasena, V; Coorey, R; Chakrabarti-Bell, S; Johnson, S K

    2016-01-01

    Lupin is an undervalued legume despite its high protein and dietary fiber content and potential health benefits. This review focuses on the nutritional value, health benefits, and technological effects of incorporating lupin flour into wheat-based bread. Results of clinical studies suggest that consuming lupin compared to wheat bread and other baked products reduce chronic disease risk markers; possibly due to increased protein and dietary fiber and bioactive compounds. However, lupin protein allergy has also been recorded. Bread quality has been improved when 10% lupin flour is substituted for refined wheat flour; possibly due to lupin-wheat protein cross-linking assisting bread volume and the high water-binding capacity (WBC) of lupin fiber delaying staling. Above 10% substitution appears to reduce bread quality due to lupin proteins low elasticity and the high WBC of its dietary fiber interrupting gluten network development. Gaps in understanding of the role of lupin flour in bread quality include the optimal formulation and processing conditions to maximize lupin incorporation, role of protein cross-linking, antistaling functionality, and bioactivity of its γ-conglutin protein. PMID:25675266

  13. A new proposal for benefit-less-risk analysis in clinical trials.

    PubMed

    Chuang-Stein, C

    1994-02-01

    In this paper, we propose a method to discount the observed benefit of a treatment by the observed risk in order to facilitate the benefit-less-risk comparison of treatments in a clinical trial. The discounting, applied to each individual in a trial, utilizes a method proposed by Chuang-Stein and co-authors to consolidate the safety data collected in the trial. The collating of the safety information allows one to estimate quantitatively the risk experienced by each individual, and therefore enables the construction of a risk-adjusted benefit measure for the same individual. We discuss the rationale for the adjusting method and examine its impact on the inference. When the discounting process reflects an individual's choice, the results should be interpreted at the individual level. An example is given to illustrate the approach. PMID:7908619

  14. [The contribution of clinical cancer registries to benefit assessments: Requirements and first results].

    PubMed

    Klinkhammer-Schalke, Monika; Hofstädter, Ferdinand; Gerken, Michael; Benz, Stefan

    2016-01-01

    Following the adoption of the Cancer Screening and Registry Act (KFRG) to advance the development of the early detection of cancer and to promote quality assurance through Clinical Cancer Registries according to Sect. 65c SGB V, the question is raised as to what extent population-based clinical cancer registries may contribute not only to direct patient treatment benefits, but also to the requirements of health research and to other issues such as, for example, the evaluation of the benefit of new pharmaceutical products. Efforts to improve a nationwide quality management for oncology have so far not been successful in the development of comprehensive documentation at all levels of care. New organizational structures such as population-based clinical cancer registries were supposed to solve this problem more sufficiently, but they must be accompanied by valid trans-sectorial documentation and evaluation of clinical data. The need for specific real-life outcomes (effectiveness) of specific therapies has led to calls for data from outside randomised clinical trials (efficacy). First results are demonstrated in the present article. PMID:27320026

  15. Cooperative study of clinical benefits from use of the fully portable blood irradiator

    SciTech Connect

    Hungate, F.P.

    1994-10-01

    This report looks at the clinical benefits from use of a fully portable blood irradiator, techniques developed by Pacific Northwest Laboratory. Significant accomplishments included the following: blood irradiators were successfully fabricated by PNL; irradiators were activated at the University of Missouri and quality tested at PNL; A-V shunts for irradiators were successfully fabricated in the PNL plastics shop; all activities necessary for experimental work on animals using the blood irradiators were completed.

  16. Lack of Benefit for the Addition of Androgen Deprivation Therapy to Dose-Escalated Radiotherapy in the Treatment of Intermediate- and High-Risk Prostate Cancer

    SciTech Connect

    Krauss, Daniel; Kestin, Larry; Ye, Hong; Brabbins, Donald; Ghilezan, Michel; Gustafson, Gary; Vicini, Frank; Martinez, Alvaro

    2011-07-15

    Purpose: Assessment of androgen deprivation therapy (ADT) benefits for prostate cancer treated with dose-escalated radiotherapy (RT). Methods and Materials: From 1991 to 2004, 1,044 patients with intermediate- (n = 782) or high-risk (n = 262) prostate cancer were treated with dose-escalated RT at William Beaumont Hospital. Patients received external-beam RT (EBRT) alone, brachytherapy (high or low dose rate), or high dose rate brachytherapy plus pelvic EBRT. Intermediate-risk patients had Gleason score 7, prostate-specific antigen (PSA) 10.0-19.9 ng/mL, or Stage T2b-T2c. High-risk patients had Gleason score 8-10, PSA {>=}20, or Stage T3. Patients were additionally divided specifically by Gleason score, presence of palpable disease, and PSA level to further define subgroups benefitting from ADT. Results: Median follow-up was 5 years; 420 patients received ADT + dose-escalated RT, and 624 received dose-escalated RT alone. For all patients, no advantages in any clinical endpoints at 8 years were associated with ADT administration. No differences in any endpoints were associated with ADT administration based on intermediate- vs. high-risk group or RT modality when analyzed separately. Patients with palpable disease plus Gleason {>=}8 demonstrated improved clinical failure rates and a trend toward improved survival with ADT. Intermediate-risk patients treated with brachytherapy alone had improved biochemical control when ADT was given. Conclusion: Benefits of ADT in the setting of dose-escalated RT remain poorly defined. This question must continue to be addressed in prospective study.

  17. First results from a hybrid prototype CT scanner for exploring benefits of quantum-counting in clinical CT

    NASA Astrophysics Data System (ADS)

    Kappler, S.; Hannemann, T.; Kraft, E.; Kreisler, B.; Niederloehner, D.; Stierstorfer, K.; Flohr, T.

    2012-03-01

    μWe introduce a novel hybrid prototype scanner built to explore benefits of the quantum-counting technique in the context of clinical CT. The scanner is equipped with two measurement systems. One is a CdTe-based counting detector with 22cm field-of-view. Its revised ASIC architecture allows configuration of the counter thresholds of the 225m small sub-pixels in chess patterns, enabling data acquisition in four energy bins or studying high-flux scenarios with pile-up trigger. The other one is a conventional GOS-based energy-integrating detector from a clinical CT scanner. The integration of both detection technologies in one CT scanner provides two major advantages. It allows direct comparison of image quality and contrast reproduction as well as instantaneous quantification of the relative dose usage and material separation performance achievable with counting techniques. In addition, data from the conventional detector can be used as complementary information during reconstruction of the images from the counting device. In this paper we present CT images acquired with the hybrid prototype scanner, illustrate its underlying conceptual methods, and provide first experimental results quantifying clinical benefits of quantum-counting CT.

  18. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).

    PubMed

    Cherny, N I; Sullivan, R; Dafni, U; Kerst, J M; Sobrero, A; Zielinski, C; de Vries, E G E; Piccart, M J

    2015-08-01

    The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long-term survival). Indeed, in the absence of a standardised approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented, discussed and promoted as major advances or 'breakthroughs'. Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high-quality clinical trials, the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the magnitude of clinical benefit for cancer medicines, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). This tool uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment. The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care, helping to frame the appropriate use of limited public and personal resources to deliver cost-effective and affordable cancer care. The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis. PMID:26026162

  19. Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 2

    PubMed Central

    McRorie, Johnson W.

    2015-01-01

    Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. In this 2-part series, the first part (previous issue) described the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (current issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972619

  20. Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 1

    PubMed Central

    McRorie, Johnson W.

    2015-01-01

    Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. The first part (current issue) of this 2-part series will focus on the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (next issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972618

  1. [Radiotherapy for soft tissue sarcomas: Technical evolution and impact on clinical benefit].

    PubMed

    Llacer-Moscardo, C; Bourgier, C; Morel, A; Fenoglietto, P; Carrère, S; Firmin, N; Azria, D

    2016-10-01

    The standard treatment for extremity soft tissue sarcomas is based on the association of surgery and radiotherapy. This strategy allows local control improvement with the risk of increased toxicity. There is therefore a growing interest to identify those patients who will benefit from radiotherapy and those who will have the same local control with surgery alone. Furthermore, the development of toxicity has been correlated with the extension of the irradiated volume and the volume receiving high doses. Technological development as intensity modulated radiotherapy and image-guided radiotherapy allows limited irradiated volume improving the protection of the organs at risk leading to clinical benefit improvement. Moreover, efforts are being done to improve local control for the patients at high risk of local relapse. In this paper, we discuss all these mentioned aspects.

  2. [Radiotherapy for soft tissue sarcomas: Technical evolution and impact on clinical benefit].

    PubMed

    Llacer-Moscardo, C; Bourgier, C; Morel, A; Fenoglietto, P; Carrère, S; Firmin, N; Azria, D

    2016-10-01

    The standard treatment for extremity soft tissue sarcomas is based on the association of surgery and radiotherapy. This strategy allows local control improvement with the risk of increased toxicity. There is therefore a growing interest to identify those patients who will benefit from radiotherapy and those who will have the same local control with surgery alone. Furthermore, the development of toxicity has been correlated with the extension of the irradiated volume and the volume receiving high doses. Technological development as intensity modulated radiotherapy and image-guided radiotherapy allows limited irradiated volume improving the protection of the organs at risk leading to clinical benefit improvement. Moreover, efforts are being done to improve local control for the patients at high risk of local relapse. In this paper, we discuss all these mentioned aspects. PMID:27614501

  3. Successful implementation of biochar carbon sequestration in European soils requires additional benefits and close collaboration with the bioenergy sector

    NASA Astrophysics Data System (ADS)

    Hauggaard-Nielsen, Henrik; Müller-Stöver, Dorette; Bruun, Esben W.; Petersen, Carsten T.

    2014-05-01

    Biochar soil application has been proposed as a measure to mitigate climate change and on the same time improve soil fertility by increased soil carbon sequestration. However, while on tropical soils the beneficial effects of biochar application on crop growth often become immediately apparent, it has been shown to be more difficult to demonstrate these effects on the more fertile soils in temperate regions. Therefore and because of the lack of carbon credits for farmers, it is necessary to link biochar application to additional benefits, both related to agricultural as well as to bioenergy production. Thermal gasification of biomass is an efficient (95% energy efficiency) and flexible way (able to cope with many different and otherwise difficult-to-handle biomass fuels) to generate bioenergy, while producing a valuable by-product - gasification biochar, containing recalcitrant carbon and essential crop nutrients. The use of the residual char product in agricultural soils will add value to the technology as well as result in additional soil benefits such as providing plant nutrients and improving soil water-holding capacity while reducing leaching risks. From a soil column (30 x 130 cm) experiment with gasification straw biochar amendment to coarse sandy subsoil increased root density of barley at critical depths in the soil profile reducing the mechanical resistance was shown, increasing yields, and the soil's capacity to store plant available water. Incorporation of residuals from a bioenergy technology like gasification show great potentials to reduce subsoil constraints increasing yield potentials on poor soils. Another advantage currently not appropriately utilized is recovery of phosphorus (P). In a recent pot experiments char products originating from low-temperature gasification of various biofuels were evaluated for their suitability as P fertilizers. Wheat straw gasification biochar generally had a low P content but a high P plant availability. To improve

  4. System-Agnostic Clinical Decision Support Services: Benefits and Challenges for Scalable Decision Support

    PubMed Central

    Kawamoto, Kensaku; Del Fiol, Guilherme; Orton, Charles; Lobach, David F

    2010-01-01

    System-agnostic clinical decision support (CDS) services provide patient evaluation capabilities that are independent of specific CDS systems and system implementation contexts. While such system-agnostic CDS services hold great potential for facilitating the widespread implementation of CDS systems, little has been described regarding the benefits and challenges of their use. In this manuscript, the authors address this need by describing potential benefits and challenges of using a system-agnostic CDS service. This analysis is based on the authors’ formal assessments of, and practical experiences with, various approaches to developing, implementing, and maintaining CDS capabilities. In particular, the analysis draws on the authors’ experience developing and leveraging a system-agnostic CDS Web service known as SEBASTIAN. A primary potential benefit of using a system-agnostic CDS service is the relative ease and flexibility with which the service can be leveraged to implement CDS capabilities across applications and care settings. Other important potential benefits include facilitation of centralized knowledge management and knowledge sharing; the potential to support multiple underlying knowledge representations and knowledge resources through a common service interface; improved simplicity and componentization; easier testing and validation; and the enabling of distributed CDS system development. Conversely, important potential challenges include the increased effort required to develop knowledge resources capable of being used in many contexts and the critical need to standardize the service interface. Despite these challenges, our experiences to date indicate that the benefits of using a system-agnostic CDS service generally outweigh the challenges of using this approach to implementing and maintaining CDS systems. PMID:21603281

  5. Experiences of clinical tutors with English as an additional language (EAL) students.

    PubMed

    Lu, Hongyan; Maithus, Caroline

    2012-11-01

    Clinical tutors, referred to in the international literature as clinical supervisors, facilitators, mentors or instructors, are responsible for providing and supervising workplace learning opportunities for groups of Bachelor of Nursing (BN) students. They also play a key role in assessing students. The role modeling and support provided by both clinical tutors and registered nurses (RN) or nurse preceptors helps students become familiar with the language in which nursing work is realised. As BN student cohorts in New Zealand have become more diverse in terms of cultures, ethnicities and language backgrounds, clinical tutors have to directly facilitate the development of context-specific and client-focused communication skills for students who speak English as an additional language. We undertook a study which looked at the perceptions of new nursing graduates with English as an additional language (EAL) on the development of spoken language skills for the clinical workplace. As well as interviewing graduates, we spoke to four clinical tutors in order to elicit their views on the language development of EAL students in previous cohorts. This article reports on the themes which emerged from the interviews with the tutors. These include goal setting for communication, integrating students into nursing work, making assessment less stressful, and endorsing independent learning strategies. Based on their observations and on other published research we make some suggestions about ways both clinical tutors and EAL students within their teaching groups could be supported in the development of communication skills for clinical practice.

  6. Experiences of clinical tutors with English as an additional language (EAL) students.

    PubMed

    Lu, Hongyan; Maithus, Caroline

    2012-11-01

    Clinical tutors, referred to in the international literature as clinical supervisors, facilitators, mentors or instructors, are responsible for providing and supervising workplace learning opportunities for groups of Bachelor of Nursing (BN) students. They also play a key role in assessing students. The role modeling and support provided by both clinical tutors and registered nurses (RN) or nurse preceptors helps students become familiar with the language in which nursing work is realised. As BN student cohorts in New Zealand have become more diverse in terms of cultures, ethnicities and language backgrounds, clinical tutors have to directly facilitate the development of context-specific and client-focused communication skills for students who speak English as an additional language. We undertook a study which looked at the perceptions of new nursing graduates with English as an additional language (EAL) on the development of spoken language skills for the clinical workplace. As well as interviewing graduates, we spoke to four clinical tutors in order to elicit their views on the language development of EAL students in previous cohorts. This article reports on the themes which emerged from the interviews with the tutors. These include goal setting for communication, integrating students into nursing work, making assessment less stressful, and endorsing independent learning strategies. Based on their observations and on other published research we make some suggestions about ways both clinical tutors and EAL students within their teaching groups could be supported in the development of communication skills for clinical practice. PMID:23421011

  7. Net Clinical Benefit of Oral Anticoagulants: A Multiple Criteria Decision Analysis

    PubMed Central

    Yang, Yea-Huei Kao; Lu, Christine Y.

    2015-01-01

    Background This study quantitatively evaluated the comparative efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, and apizaban) and warfarin for treatment of nonvalvular atrial fibrillation. We also compared these agents under different scenarios, including population with high risk of stroke and for primary vs. secondary stroke prevention. Methods We used multiple criteria decision analysis (MCDA) to assess the benefit-risk of these medications. Our MCDA models contained criteria for benefits (prevention of ischemic stroke and systemic embolism) and risks (intracranial and extracranial bleeding). We calculated a performance score for each drug accounting for benefits and risks in comparison to treatment alternatives. Results Overall, new agents had higher performance scores than warfarin; in order of performance scores: dabigatran 150 mg (0.529), rivaroxaban (0.462), apixaban (0.426), and warfarin (0.191). For patients at a higher risk of stroke (CHADS2 score≥3), apixaban had the highest performance score (0.686); performance scores for other drugs were 0.462 for dabigatran 150 mg, 0.392 for dabigatran 110 mg, 0.271 for rivaroxaban, and 0.116 for warfarin. Dabigatran 150 mg had the highest performance score for primary stroke prevention, while dabigatran 110 mg had the highest performance score for secondary prevention. Conclusions Our results suggest that new oral anticoagulants might be preferred over warfarin. Selecting appropriate medicines according to the patient’s condition based on information from an integrated benefit-risk assessment of treatment options is crucial to achieve optimal clinical outcomes. PMID:25897861

  8. Engaging diverse social and cultural worlds: perspectives on benefits in international clinical research from South african communities.

    PubMed

    Zvonareva, Olga; Engel, Nora; Ross, Eleanor; Berghmans, Ron; Dhai, Ames; Krumeich, Anja

    2015-04-01

    The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South African communities on benefits in international clinical research. Twenty-four individuals with and without experience of being involved in clinical research participated in in-depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post-trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations. PMID:23725088

  9. Engaging diverse social and cultural worlds: perspectives on benefits in international clinical research from South african communities.

    PubMed

    Zvonareva, Olga; Engel, Nora; Ross, Eleanor; Berghmans, Ron; Dhai, Ames; Krumeich, Anja

    2015-04-01

    The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South African communities on benefits in international clinical research. Twenty-four individuals with and without experience of being involved in clinical research participated in in-depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post-trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations.

  10. Impact of the quebec school-based hepatitis B immunization program and potential benefit of the addition of an infant immunization program.

    PubMed

    Gîlca, Vladimir; Duval, Bernard; Boulianne, Nicole; Dion, Réjean; De Serres, Gaston

    2006-04-01

    Ten years after a school-based hepatitis B immunization program was implemented, we conducted a study to assess the impact of the program, vaccine failures, risk factors and the number of cases potentially preventable by the addition of an infant vaccination program. The preteen vaccination program is highly effective. An infant immunization program would bring additional benefits. PMID:16567995

  11. Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.

    PubMed

    Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn

    2014-06-01

    This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed. PMID:24682644

  12. Statins as anti-cancer therapy; Can we translate preclinical and epidemiologic data into clinical benefit?

    PubMed

    Chae, Young Kwang; Yousaf, Muhammad; Malecek, Mary-Kate; Carneiro, Benedito; Chandra, Sunandana; Kaplan, Jason; Kalyan, Aparna; Sassano, Antonella; Platanias, Leonidas C; Giles, Francis

    2015-12-01

    Statins, the most commonly prescribed class of drug, have demonstrated effects beyond cholesterol reduction including anti-tumor and immunomodulatory properties. Several epidemiological studies have suggested an anti-neoplastic effect of statins evidenced by reductions in cancer incidence and cancer-related mortality. Clinical trials on statins as part of therapy for cancer have generated interest in the oncology community. Statins have been investigated for a variety of cancers, early and late stage, and in combination with chemotherapy and radiation. So far promising results have been reported with statin use in pediatric brainstem tumors, early stage breast cancer, hepatocellular carcinoma (HCC), colorectal cancer (CRC), refractory or relapsed multiple myeloma (MM), and refractory acute myeloid leukemia (AML). There is still much investigation to be completed to determine which subtypes of patients benefit from statin therapy, how statins may potentiate other anticancer approaches, and the appropriate dosing schedule to use.

  13. Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.

    PubMed

    Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn

    2014-06-01

    This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.

  14. Harms, benefits, and the nature of interventions in pragmatic clinical trials

    PubMed Central

    Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

    2015-01-01

    To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials (PCTs) are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of PCTs. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of PCT interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for PCTs. Specifically, further examination is needed to identify how the types and targets of PCT interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this paper, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of PCT interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of PCT interventions and discuss implications for patients, clinicians, and healthcare systems. PMID:26374680

  15. Pellagra-like condition is xeroderma pigmentosum/Cockayne syndrome complex and niacin confers clinical benefit.

    PubMed

    Hijazi, H; Salih, M A; Hamad, M H A; Hassan, H H; Salih, S B M; Mohamed, K A; Mukhtar, M M; Karrar, Z A; Ansari, S; Ibrahim, N; Alkuraya, F S

    2015-01-01

    An extremely rare pellagra-like condition has been described, which was partially responsive to niacin and associated with a multisystem involvement. The condition was proposed to represent a novel autosomal recessive entity but the underlying mutation remained unknown for almost three decades. The objective of this study was to identify the causal mutation in the pellagra-like condition and investigate the mechanism by which niacin confers clinical benefit. Autozygosity mapping and exome sequencing were used to identify the causal mutation, and comet assay on patient fibroblasts before and after niacin treatment to assess its effect on DNA damage. We identified a single disease locus that harbors a novel mutation in ERCC5, thus confirming that the condition is in fact xeroderma pigmentosum/Cockayne syndrome (XP/CS) complex. Importantly, we also show that the previously described dermatological response to niacin is consistent with a dramatic protective effect against ultraviolet-induced DNA damage in patient fibroblasts conferred by niacin treatment. Our findings show the power of exome sequencing in reassigning previously described novel clinical entities, and suggest a mechanism for the dermatological response to niacin in patients with XP/CS complex. This raises interesting possibilities about the potential therapeutic use of niacin in XP.

  16. Genomic profiling of lung adenocarcinoma patients reveals therapeutic targets and confers clinical benefit when standard molecular testing is negative

    PubMed Central

    Lim, Sun Min; Kim, Eun Young; Kim, Hye Ryun; Ali, Siraj M.; Greenbowe, Joel R.; Shim, Hyo Sup; Chang, Hyun; Lim, Seungtaek; Paik, Soonmyung; Cho, Byoung Chul

    2016-01-01

    Background: Identification of clinically relevant oncogenic drivers in advanced cancer is critical in selecting appropriate targeted therapy. Using next-generation sequencing (NGS)-based clinical cancer gene assay, we performed comprehensive genomic profiling (CGP) of advanced cases of lung adenocarcinoma. Methods: Formalin-fixed paraffin-embedded tumors from 51 lung adenocarcinoma patients whose tumors previously tested negative for EGFR/KRAS/ALK by conventional methods were collected, and CGP was performed via hybridization capture of 4,557 exons from 287 cancer-related genes and 47 introns from 19 genes frequently rearranged in cancer. Results: Genomic profiles of all 51 cases were obtained, with a median coverage of 564x and a total of 190 individual genomic alterations (GAs). GAs per specimen was a mean of 3.7 (range 0-10).Cancer genomes are characterized by 50% (80/190) non-synonymous base substitutions, 15% (29/190) insertions or deletion, and 3% (5/190) splice site mutation. TP53 mutation was the most common GAs (15%, n=29/190), followed by CDKN2A homozygous loss (5%, n=10/190), KRAS mutation (4%, n=8/190), EGFR mutation (4%, n=8/190) and MDM2 amplification (2%, n=5/190). As per NCCN guidelines, targetable GAs were identified in 16 patients (31%) (BRAF mutation [n=1], EGFR mutation [n=8], ERBB2 mutation [n=4], MET amplification [n=1], KIF5B-RET rearrangement [n=2], CCDC6-RET rearrangement [n=1], CD74-ROS1 rearrangement [n=1], EZR-ROS1 rearrangement [n=5], and SLC34A2-ROS1 rearrangement [n=1]). Conclusion: Fifty eight percent of patients wild type by standard testing for EGFR/KRAS/ALK have GAs identifiable by CGP that suggest benefit from target therapy. CGP used when standard molecular testing for NSCLC is negative can reveal additional avenues of benefit from targeted therapy. PMID:26992220

  17. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial.

    PubMed

    Added, Marco Aurélio Nemitalla; Costa, Leonardo Oliveira Pena; de Freitas, Diego Galace; Fukuda, Thiago Yukio; Monteiro, Renan Lima; Salomão, Evelyn Cassia; de Medeiros, Flávia Cordeiro; Costa, Lucíola da Cunha Menezes

    2016-07-01

    Study Design Randomized controlled trial. Background Many clinical practice guidelines endorse both manual therapy and exercise as effective treatment options for patients with low back pain. To optimize the effects of the treatments recommended by the guidelines, a new intervention known as Kinesio Taping is being widely used in these patients. Objectives To determine the effectiveness of Kinesio Taping in patients with chronic nonspecific low back pain when added to a physical therapy program consisting of exercise and manual therapy. Methods One hundred forty-eight patients with chronic nonspecific low back pain were randomly allocated to receive 10 (twice weekly) sessions of physical therapy, consisting of exercise and manual therapy, or the same treatment with the addition of Kinesio Taping applied to the lower back. The primary outcomes were pain intensity and disability (5 weeks after randomization) and the secondary outcomes were pain intensity, disability (3 months and 6 months after randomization), global perceived effect, and satisfaction with care (5 weeks after treatment). Data were collected by a blinded assessor. Results No between-group differences were observed in the primary outcomes of pain intensity (mean difference, -0.01 points; 95% confidence interval [CI]: -0.88, 0.85) or disability (mean difference, 1.14 points; 95% CI: -0.85, 3.13) at 5 weeks' follow-up. In addition, no between-group differences were observed for any of the other outcomes evaluated, except for disability 6 months after randomization (mean difference, 2.01 points; 95% CI: 0.03, 4.00) in favor of the control group. Conclusion Patients who received a physical therapy program consisting of exercise and manual therapy did not get additional benefit from the use of Kinesio Taping. Level of Evidence Therapy, level 1b. Prospectively registered May 28, 2013 at www.ClinicalTrials.gov (NCT01866332). J Orthop Sports Phys Ther 2016;46(7):506-513. Epub 6 Jun 2016. doi:10.2519/jospt.2016.6590.

  18. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial.

    PubMed

    Added, Marco Aurélio Nemitalla; Costa, Leonardo Oliveira Pena; de Freitas, Diego Galace; Fukuda, Thiago Yukio; Monteiro, Renan Lima; Salomão, Evelyn Cassia; de Medeiros, Flávia Cordeiro; Costa, Lucíola da Cunha Menezes

    2016-07-01

    Study Design Randomized controlled trial. Background Many clinical practice guidelines endorse both manual therapy and exercise as effective treatment options for patients with low back pain. To optimize the effects of the treatments recommended by the guidelines, a new intervention known as Kinesio Taping is being widely used in these patients. Objectives To determine the effectiveness of Kinesio Taping in patients with chronic nonspecific low back pain when added to a physical therapy program consisting of exercise and manual therapy. Methods One hundred forty-eight patients with chronic nonspecific low back pain were randomly allocated to receive 10 (twice weekly) sessions of physical therapy, consisting of exercise and manual therapy, or the same treatment with the addition of Kinesio Taping applied to the lower back. The primary outcomes were pain intensity and disability (5 weeks after randomization) and the secondary outcomes were pain intensity, disability (3 months and 6 months after randomization), global perceived effect, and satisfaction with care (5 weeks after treatment). Data were collected by a blinded assessor. Results No between-group differences were observed in the primary outcomes of pain intensity (mean difference, -0.01 points; 95% confidence interval [CI]: -0.88, 0.85) or disability (mean difference, 1.14 points; 95% CI: -0.85, 3.13) at 5 weeks' follow-up. In addition, no between-group differences were observed for any of the other outcomes evaluated, except for disability 6 months after randomization (mean difference, 2.01 points; 95% CI: 0.03, 4.00) in favor of the control group. Conclusion Patients who received a physical therapy program consisting of exercise and manual therapy did not get additional benefit from the use of Kinesio Taping. Level of Evidence Therapy, level 1b. Prospectively registered May 28, 2013 at www.ClinicalTrials.gov (NCT01866332). J Orthop Sports Phys Ther 2016;46(7):506-513. Epub 6 Jun 2016. doi:10.2519/jospt.2016

  19. An academic, clinical and industrial update on electrospun, additive manufactured and imprinted medical devices.

    PubMed

    Ryan, Christina N M; Fuller, Kieran P; Larrañaga, Aitor; Biggs, Manus; Bayon, Yves; Sarasua, Jose R; Pandit, Abhay; Zeugolis, Dimitrios I

    2015-01-01

    Electrospinning, additive manufacturing and imprint lithography scaffold fabrication technologies have attracted great attention in biomedicine, as they allow production of two- and three- dimensional constructs with tuneable topographical and geometrical features. In vitro data demonstrate that electrospun and imprinted substrates offer control over permanently differentiated and stem cell function. Advancements in functionalisation strategies have further enhanced the bioactivity and reparative capacity of electrospun and additive manufactured devices, as has been evidenced in several preclinical models. Despite this overwhelming success in academic setting, only a few technologies have reached the clinic and only a fraction of them have become commercially available products.

  20. Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment.

    PubMed

    Tobin, Thomas J; Tobin, Mary L

    2015-01-01

    Smoking cessation remains a positive therapeutic goal and should be encouraged for the millions of individuals who continue to smoke and struggle to quit. While psychiatric nurses should encourage patients to start or continue smoking cessation therapies, they must be aware of the additional safety concerns relating to the use of varenicline (Chantix). Research published subsequent to the last clinical update in this journal (Tobin, 2007 ) has prompted additional warnings from the Food and Drug Administration concerning varenicline for smoking cessation therapy. In particular, clinicians need to be aware of increased concerns about varenicline's association with neuropsychiatric side effects, seizures, and alcohol interactions. PMID:26514264

  1. Natural antioxidants as food and feed additives to promote health benefits and quality of meat products: A review.

    PubMed

    Jiang, Jiang; Xiong, Youling L

    2016-10-01

    Fresh and processed meats offer numerous nutritional and health benefits and provide unique eating satisfaction in the lifestyle of the modern society. However, consumption of red meat including processed products is subjected to increasing scrutiny due to the health risks associated with cytotoxins that potentially could be generated during meat preparation. Evidence from recent studies suggests free radical pathways as a plausible mechanism for toxin formation, and antioxidants have shown promise to mitigate process-generated chemical hazards. The present review discusses the involvements of lipid and protein oxidation in meat quality, nutrition, safety, and organoleptic properties; animal production and meat processing strategies which incorporate natural antioxidants to enhance the nutritional and health benefits of meat; and the application of mixed or purified natural antioxidants to eliminate or minimize the formation of carcinogens for chemical safety of cooked and processed meats.

  2. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects.

    PubMed

    Nishimura, Masaji

    2016-04-01

    High-flow nasal cannula (HFNC) oxygen therapy is carried out using an air/oxygen blender, active humidifier, single heated tube, and nasal cannula. Able to deliver adequately heated and humidified medical gas at flows up to 60 L/min, it is considered to have a number of physiological advantages compared with other standard oxygen therapies, including reduced anatomical dead space, PEEP, constant F(IO2), and good humidification. Although few large randomized clinical trials have been performed, HFNC has been gaining attention as an alternative respiratory support for critically ill patients. Published data are mostly available for neonates. For critically ill adults, however, evidence is uneven because the reports cover various subjects with diverse underlying conditions, such as hypoxemic respiratory failure, exacerbation of COPD, postextubation, preintubation oxygenation, sleep apnea, acute heart failure, and conditions entailing do-not-intubate orders. Even so, across the diversity, many published reports suggest that HFNC decreases breathing frequency and work of breathing and reduces the need for respiratory support escalation. Some important issues remain to be resolved, such as definitive indications for HFNC and criteria for timing the starting and stopping of HFNC and for escalating treatment. Despite these issues, HFNC has emerged as an innovative and effective modality for early treatment of adults with respiratory failure with diverse underlying diseases. PMID:27016353

  3. Investigation of benefits and costs of an ophthalmic outreach clinic in general practice.

    PubMed Central

    Gillam, S J; Ball, M; Prasad, M; Dunne, H; Cohen, S; Vafidis, G

    1995-01-01

    BACKGROUND: With the advent of general practitioner fundholding, there has been growth in outreach clinics covering many specialties. The benefits and costs of this model of service provision are unclear. AIM: A pilot study aimed to evaluate an outreach model of ophthalmic care in terms of its impact on general practitioners, their use of secondary ophthalmology services, patients' views, and costs. METHOD: A prospective study, from April 1992 to March 1993, of the introduction of an ophthalmic outreach service in 17 general practices in London was undertaken. An ophthalmic outreach team, comprising an ophthalmic medical practitioner and an ophthalmic nurse, held clinics in the practices once a month. Referral rates to Edgware General Hospital ophthalmology outpatient department over one year from the study practices were compared with those from 17 control practices. General practitioners' assessments of the scheme and its impact on their knowledge and practice of ophthalmology were sought through a postal survey of all partners and interviews with one partner in each practice. Patient surveys were conducted using self-administered structured questionnaires. A costings exercise compared the outreach model with the conventional hospital ophthalmology outpatient clinic. RESULTS: Of 1309 patients seen by the outreach team in the study practices, 480 (37%) were referred to the ophthalmology outpatient department. The annual referral rate to this department from control practices was 9.5 per 10,000 registered patients compared with 3.8 per 10,000 registered patients from study practices. A total of 1187 patients were referred to the outpatient department from control practices. An increase in knowledge of ophthalmology was reported by 18 of 47 general practitioners (38%). Nineteen (40%) of 47 general practitioners took advantage of the opportunity for inservice training with the outreach team; they were more likely to change their routine practice for ophthalmic care

  4. Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson's disease.

    PubMed

    Master, Zubin; McLeod, Marcus; Mendez, Ivar

    2007-03-01

    Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson's disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinical research, a favourable benefit to risk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical studies transplanting stem cells in animals and the transplantation of fetal tissue in patients with Parkinson's disease, a current set of potential benefits and risks for neural transplantation of stem cells in clinical research of Parkinson's disease are derived. The potential benefits to research participants undergoing stem cell transplantation are relief of parkinsonian symptoms and decreasing doses of parkinsonian drugs. Transplantation of stem cells as a treatment for Parkinson's disease may benefit society by providing knowledge that can be used to help determine better treatments in the future. The risks to research participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. Although some of these risks are general to neurosurgical transplantation and may not be reduced for participants, the potential risk of tumour formation and inappropriate stem cell migration must be minimised before obtaining a favourable potential benefit to risk calculus and to provide participants with a reasonable choice before they enroll in clinical studies.

  5. Clinical benefits and impact of early use of long‐acting injectable antipsychotics for schizophrenia

    PubMed Central

    Dawson, Gail; Zummo, Jacqueline

    2015-01-01

    Abstract Aim Results from clinical trials support the use of oral antipsychotics for treatment of early or first‐episode psychosis in patients with schizophrenia. This paper will review literature on the advantages of early initiation of treatment for schizophrenia and the clinical benefits of early use of long‐acting injectable antipsychotics (LAIs). Method A comprehensive literature review was conducted to identify published literature on the use of LAIs early in the treatment of schizophrenia. Results Although there is a higher response rate to initial antipsychotic treatment for a first‐episode of schizophrenia than with subsequent antipsychotic treatment, we have not effectively addressed this issue. Poor adherence to treatment is a primary cause of relapse and rehospitalization in subsequent years and was associated with higher relapse rates resulting in devastating effects and substantial economic burden. The costs of nonadherence were estimated to be $1.48 billion. Thus, a major challenge with the treatment of schizophrenia is changing poor adherence to persistence with antipsychotic therapy. LAIs are known to be at least as effective as oral antipsychotics for treating schizophrenia, and yet are underutilized. Further, LAIs address many of the problems associated with adherence to oral therapy. Recent evidence suggests that LAIs are effective for treating first‐episode psychosis and for early initiation of treatment for schizophrenia. Conclusion Although consistent antipsychotic treatment represents a critical part of treatment, a person‐centred approach to treating schizophrenia is essential for all aspects of care, including establishing and maintaining a therapeutic alliance, strengthening shared decision‐making and adherence, and achieving long‐lasting recovery. PMID:26403538

  6. Tandem oleosin genes in a cluster acquired in Brassicaceae created tapetosomes and conferred additive benefit of pollen vigor

    PubMed Central

    Huang, Chien Yu; Chen, Pei-Ying; Huang, Ming-Der; Tsou, Chih-Hua; Jane, Wann-Neng; Huang, Anthony H. C.

    2013-01-01

    During evolution, genomes expanded via whole-genome, segmental, tandem, and individual-gene duplications, and the emerged redundant paralogs would be eliminated or retained owing to selective neutrality or adaptive benefit and further functional divergence. Here we show that tandem paralogs can contribute adaptive quantitative benefit and thus have been retained in a lineage-specific manner. In Brassicaceae, a tandem oleosin gene cluster of five to nine paralogs encodes ample tapetum-specific oleosins located in abundant organelles called tapetosomes in flower anthers. Tapetosomes coordinate the storage of lipids and flavonoids and their transport to the adjacent maturing pollen as the coat to serve various functions. Transfer-DNA and siRNA mutants of Arabidopsis thaliana with knockout and knockdown of different tandem oleosin paralogs had quantitative and correlated loss of organized structures of the tapetosomes, pollen-coat materials, and pollen tolerance to dehydration. Complementation with the knockout paralog restored the losses. Cleomaceae is the family closest to Brassicaceae. Cleome species did not contain the tandem oleosin gene cluster, tapetum oleosin transcripts, tapetosomes, or pollen tolerant to dehydration. Cleome hassleriana transformed with an Arabidopsis oleosin gene for tapetum expression possessed primitive tapetosomes and pollen tolerant to dehydration. We propose that during early evolution of Brassicaceae, a duplicate oleosin gene mutated from expression in seed to the tapetum. The tapetum oleosin generated primitive tapetosomes that organized stored lipids and flavonoids for their effective transfer to the pollen surface for greater pollen vitality. The resulting adaptive benefit led to retention of tandem-duplicated oleosin genes for production of more oleosin and modern tapetosomes. PMID:23940319

  7. Survival benefit and additional value of preoperative chemoradiotherapy in resectable gastric and gastro-oesophageal junction cancer: a direct and adjusted indirect comparison meta-analysis.

    PubMed

    Kumagai, K; Rouvelas, I; Tsai, J A; Mariosa, D; Lind, P A; Lindblad, M; Ye, W; Lundell, L; Schuhmacher, C; Mauer, M; Burmeister, B H; Thomas, J M; Stahl, M; Nilsson, M

    2015-03-01

    Several phase I/II studies of chemoradiotherapy for gastric cancer have reported promising results, but the significance of preoperative radiotherapy in addition to chemotherapy has not been proven. In this study, a systematic literature search was performed to capture survival and postoperative morbidity and mortality data in randomised clinical studies comparing preoperative (chemo)radiotherapy or chemotherapy versus surgery alone, or preoperative chemoradiotherapy versus chemotherapy for gastric and/or gastro-oesophageal junction (GOJ) cancer. Hazard ratios (HRs) for overall mortality were extracted from the original studies, individual patient data provided from the principal investigators of eligible studies or the earlier published meta-analysis. The incidences of postoperative morbidities and mortalities were also analysed. In total 18 studies were eligible and data were available from 14 of these. The meta-analysis on overall survival yielded HRs of 0.75 (95% CI 0.65-0.86, P < 0.001) for preoperative (chemo)radiotherapy and 0.83 (95% CI 0.67-1.01, P = 0.065) for preoperative chemotherapy when compared to surgery alone. Direct comparison between preoperative chemoradiotherapy and chemotherapy resulted in an HR of 0.71 (95% CI 0.45-1.12, P = 0.146). Combination of direct and adjusted indirect comparisons yielded an HR of 0.86 (95% CI 0.69-1.07, P = 0.171). No statistically significant differences were seen in the risk for postoperative morbidity or mortality between preoperative treatments and surgery alone, or preoperative (chemo)radiotherapy and chemotherapy. Preoperative (chemo)radiotherapy for gastric and GOJ cancer showed significant survival benefit over surgery alone. In comparisons between preoperative chemotherapy and (chemo)radiotherapy, there is a trend towards improved survival when adding radiotherapy, without increased postoperative morbidity or mortality.

  8. Prazosin addition to fluvoxamine: A preclinical study and open clinical trial in OCD.

    PubMed

    Feenstra, Matthijs G P; Klompmakers, André; Figee, Martijn; Fluitman, Sjoerd; Vulink, Nienke; Westenberg, Herman G M; Denys, Damiaan

    2016-02-01

    The efficacy of selective serotonin reuptake inhibitors (SRIs) in psychiatric disorders may be "augmented" through the addition of atypical antipsychotic drugs. A synergistic increase in dopamine (DA) release in the prefrontal cortex has been suggested to underlie this augmentation effect, though the mechanism of action is not clear yet. We used in vivo microdialysis in rats to study DA release following the administration of combinations of fluvoxamine (10 mg/kg) and quetiapine (10 mg/kg) with various monoamine-related drugs. The results confirmed that the selective 5-HT1A antagonist WAY-100635 (0.05 mg/kg) partially blocked the fluvoxamine-quetiapine synergistic effect (maximum DA increase dropped from 325% to 214%). A novel finding is that the α1-adrenergic blocker prazosin (1 mg/kg), combined with fluvoxamine, partially mimicked the effect of augmentation (maximum DA increase 205%; area-under-the-curve 163%). As this suggested that prazosin augmentation might be tested in a clinical study, we performed an open clinical trial of prazosin 20 mg addition to SRI in therapy-resistant patients with obsessive-compulsive disorder applying for neurosurgery. A small, non-significant reduction in Yale Brown Obsessive Compulsive Scale (Y-BOCS) scores was observed in 10 patients and one patient was classified as a responder with a reduction in Y-BOCS scores of more than 25%. We suggest that future clinical studies augmenting SRIs with an α1-adrenergic blocker in less treatment resistant cases should be considered. The clinical trial "Prazosin in combination with a serotonin reuptake inhibitor for patients with Obsessive Compulsive disorder: an open label study" was registered at 24/05/2011 under trial number ISRCTN61562706: http://www.controlled-trials.com/ISRCTN61562706. PMID:26712326

  9. Applying the benefits of the AwM study in the clinic.

    PubMed

    Dodick, D W

    2008-09-01

    The Act when Mild (AwM) Study has illustrated the benefits to migraineurs of taking triptan medication when their migraine pain is still mild and within 1 h of the onset of symptoms. Yet many patients wait until the attack has fully developed before taking their medication, with potentially inferior outcomes. In order to reproduce the benefits of early intervention using the AwM paradigm in daily practice, a number of key barriers need to be addressed at both the physician and patient level. Notable physician-related barriers to be overcome, particularly at the primary care level, include accuracy of an early diagnosis of migraine in newly presenting patients, communication skills that generate a therapeutic engagement with migraine patients and enhance patient confidence, the application of knowledge about up-to-date strategies to optimize treatment outcomes, and the setting of achievable goals to avoid unrealistic expectations. Patient-related obstacles that need to be identified and overcome encompass patient attitude, expectations, and behaviour. Migraine patients may be reluctant to consult their physician, and, of those who do, many stop consulting because they perceive that physicians can do little to improve their situation. For this reason, migraine patients need to be counselled about the most appropriate medication for their level of symptoms. Moreover, patients need to be confident before they will adhere routinely to the advice they receive, and high in the priority of advice is the use of medication, particularly triptans, at the first sign of a migraine attack, rather than waiting until their attack has progressed to moderate or severe intensity. Patients who adhere to this advice are likely to experience a notable reduction in the pain, disability and time lost that they would otherwise suffer. The beneficial effects of early triptan intervention illustrated in the AwM Study can therefore be best reproduced in the clinic if the correct advice given

  10. Is there evidence-based hypolipidemic treatment with clinical benefit beyond statins?

    PubMed

    Goumas, Georgios S

    2009-01-01

    Aggressive therapy with statins to lower the low density lipoprotein cholesterol decreases cardiovascular events. Nevertheless, administration of the highest approved statin dose only offers limited additional benefit at the expense of an increased incidence of side effects. Therefore, novel compounds that further reduce the low-density lipoprotein cholesterol and at the same time have beneficial effects on other lipid parameters when added to statin therapy are under investigation. Nicotinic acid lowers the levels of the low-density lipoprotein cholesterol and triglycerides while raising the concentration of the protective high-density lipoprotein cholesterol. A significant inverse association exists between long-term intake of omega-3 fatty acids and cardiovascular mortality; these fish oils lower serum triglycerides levels. Fibrates substantially decrease triglycerides, increase high density lipoprotein cholesterol, and modestly decrease low-density lipoprotein cholesterol levels. Ezetimibe selectively inhibits cholesterol absorption in the gut. Combined therapy with ezetimibe and a statin provides an incremental reduction in the low-density lipoprotein cholesterol levels. PMID:19019838

  11. Use of clinically available PPAR agonists for heart failure; do the risks outweigh the potential benefits?

    PubMed

    Sarma, Satyam

    2012-06-01

    PPAR agonists represent a heterogeneous group of compounds that have been used in the treatment of cardiovascular and metabolic diseases for over thirty years. While the primary indications for PPAR agonist therapy focus on hyperlipidemia and diabetes, there is a growing body of pre-clinical data that suggests they may be beneficial in the treatment of heart failure; a disease marked by abnormal myocardial metabolism, fibrosis and insulin insensitivity. PPAR agonist treatment in numerous animal models of systolic heart failure have demonstrated improvement in cardiac function with decreased fibrosis, improved contractility and endothelial function. However, considerable controversy exists on the cardiac safety profile of PPAR agonists, particularly concern for inducing lipotoxicty and precipitating or worsening heart failure. In addition during pre-clinical testing, many compounds have been associated with increased death and adverse cardiovascular outcomes casting a pall over their future use for treating disorders of myocardial function. This article will review cardiac pathways involved in PPAR activation and their potential regulation of maladaptive pathways involved in heart failure and highlight molecular mechanisms that may contribute to adverse events and raise safety concerns. Specific attention will be focused on PPAR alpha and gamma, subtypes for which commercially available PPAR agonists are currently available.

  12. The Clinical Benefits of Adding a Third Dimension to Assess the Left Ventricle with Echocardiography

    PubMed Central

    Badano, Luigi P.

    2014-01-01

    Three-dimensional echocardiography is a novel imaging technique based on acquisition and display of volumetric data sets in the beating heart. This permits a comprehensive evaluation of left ventricular (LV) anatomy and function from a single acquisition and expands the diagnostic possibilities of noninvasive cardiology. It provides the possibility of quantitating geometry and function of LV without preestablished assumptions regarding cardiac chamber shape and allows an echocardiographic assessment of the LV that is less operator-dependent and therefore more reproducible. Further developments and improvements for widespread routine applications include higher spatial and temporal resolution to improve image quality, faster acquisition, processing and reconstruction, and fully automated quantitative analysis. At present, three-dimensional echocardiography complements routine 2DE in clinical practice, overcoming some of its limitations and offering additional valuable information that has led to recommending its use for routine assessment of the LV of patients in whom information about LV size and function is critical for their clinical management. PMID:24959374

  13. The Quality of Tumor Size Assessment by Contrast-Enhanced Spectral Mammography and the Benefit of Additional Breast MRI

    PubMed Central

    Lobbes, Marc B.I.; Lalji, Ulrich C.; Nelemans, Patty J.; Houben, Ivo; Smidt, Marjolein L.; Heuts, Esther; de Vries, Bart; Wildberger, Joachim E.; Beets-Tan, Regina G.

    2015-01-01

    Background - Contrast-enhanced spectral mammography (CESM) is a promising new breast imaging modality that is superior to conventional mammography for breast cancer detection. We aimed to evaluate correlation and agreement of tumor size measurements using CESM. As additional analysis, we evaluated whether measurements using an additional breast MRI exam would yield more accurate results. Methods - Between January 1st 2013 and April 1st 2014, 87 consecutive breast cancer cases that underwent CESM were collected and data on maximum tumor size measurements were gathered. In 57 cases, tumor size measurements were also available for breast MRI. Histopathological results of the surgical specimen served as gold standard in all cases. Results - The Pearson's correlation coefficients (PCC) of CESM versus histopathology and breast MRI versus histopathology were all >0.9, p<0.0001. For the agreement between measurements, the mean difference between CESM and histopathology was 0.03 mm. The mean difference between breast MRI and histopathology was 2.12 mm. Using a 2x2 contingency table to assess the frequency distribution of a relevant size discrepancy of >1 cm between the two imaging modalities and histopathological results, we did not observe any advantage of performing an additional breast MRI after CESM in any of the cases. Conclusion - Quality of tumor size measurement using CESM is good and matches the quality of these measurement assessed by breast MRI. Additional measurements using breast MRI did not improve the quality of tumor size measurements. PMID:25561979

  14. Use of generalised additive models to categorise continuous variables in clinical prediction

    PubMed Central

    2013-01-01

    Background In medical practice many, essentially continuous, clinical parameters tend to be categorised by physicians for ease of decision-making. Indeed, categorisation is a common practice both in medical research and in the development of clinical prediction rules, particularly where the ensuing models are to be applied in daily clinical practice to support clinicians in the decision-making process. Since the number of categories into which a continuous predictor must be categorised depends partly on the relationship between the predictor and the outcome, the need for more than two categories must be borne in mind. Methods We propose a categorisation methodology for clinical-prediction models, using Generalised Additive Models (GAMs) with P-spline smoothers to determine the relationship between the continuous predictor and the outcome. The proposed method consists of creating at least one average-risk category along with high- and low-risk categories based on the GAM smooth function. We applied this methodology to a prospective cohort of patients with exacerbated chronic obstructive pulmonary disease. The predictors selected were respiratory rate and partial pressure of carbon dioxide in the blood (PCO2), and the response variable was poor evolution. An additive logistic regression model was used to show the relationship between the covariates and the dichotomous response variable. The proposed categorisation was compared to the continuous predictor as the best option, using the AIC and AUC evaluation parameters. The sample was divided into a derivation (60%) and validation (40%) samples. The first was used to obtain the cut points while the second was used to validate the proposed methodology. Results The three-category proposal for the respiratory rate was ≤ 20;(20,24];> 24, for which the following values were obtained: AIC=314.5 and AUC=0.638. The respective values for the continuous predictor were AIC=317.1 and AUC=0.634, with no statistically

  15. Net benefits: assessing the effectiveness of clinical networks in Australia through qualitative methods

    PubMed Central

    2012-01-01

    Background In the 21st century, government and industry are supplementing hierarchical, bureaucratic forms of organization with network forms, compatible with principles of devolved governance and decentralization of services. Clinical networks are employed as a key health policy approach to engage clinicians in improving patient care in Australia. With significant investment in such networks in Australia and internationally, it is important to assess their effectiveness and sustainability as implementation mechanisms. Methods In two purposively selected, musculoskeletal clinical networks, members and stakeholders were interviewed to ascertain their perceptions regarding key factors relating to network effectiveness and sustainability. We adopted a three-level approach to evaluating network effectiveness: at the community, network, and member levels, across the network lifecycle. Results Both networks studied are advisory networks displaying characteristics of the ‘enclave’ type of non-hierarchical network. They are hybrids of the mandated and natural network forms. In the short term, at member level, both networks were striving to create connectivity and collaboration of members. Over the short to medium term, at network level, both networks applied multi-disciplinary engagement in successfully developing models of care as key outputs, and disseminating information to stakeholders. In the long term, at both community and network levels, stakeholders would measure effectiveness by the broader statewide influence of the network in changing and improving practice. At community level, in the long term, stakeholders acknowledged both networks had raised the profile, and provided a ‘voice’ for musculoskeletal conditions, evidencing some progress with implementation of the network mission while pursuing additional implementation strategies. Conclusions This research sheds light on stakeholders’ perceptions of assessing clinical network effectiveness at

  16. A comparison of the additional protocols of the five nuclear weapon states and the ensuing safeguards benefits to international nonproliferation efforts

    SciTech Connect

    Uribe, Eva C; Sandoval, M Analisa; Sandoval, Marisa N; Boyer, Brian D; Leitch, Rosalyn M

    2009-01-01

    With the 6 January 2009 entry into force of the Additional Protocol by the United States of America, all five declared Nuclear Weapon States that are part of the Nonproliferation Treaty have signed, ratified, and put into force the Additional Protocol. This paper makes a comparison of the strengths and weaknesses of the five Additional Protocols in force by the five Nuclear Weapon States with respect to the benefits to international nonproliferation aims. This paper also documents the added safeguards burden to the five declared Nuclear Weapon States that these Additional Protocols put on the states with respect to access to their civilian nuclear programs and the hosting of complementary access activities as part of the Additional Protocol.

  17. Clinical inquiries. What are the risks and benefits of elective induction for uncomplicated term pregnancies?

    PubMed

    Santana, Wendis; Meyer, Albert; Flake, Donna; Neher, Jon O

    2006-11-01

    Elective induction of labor for term, singleton, uncomplicated pregnancies appears safe for both the mother and infant (strength of recommendation [SOR]: B). The benefit of elective induction for nonmedical reasons is unclear (SOR: B).

  18. ADDITIONAL DEMOGRAPHIC AND CLINICAL EVIDENCES ON THE RELEVANCE OF THE SYSTEMIC THERAPY IN ALCOHOL DEPENDENCE.

    PubMed

    Alexinschi, Ovidiu; Chirita, Roxana; Manuela, Padurariu; Ciobica, Alin; Dobrin, Romeo; Petrariu, F D; Timofte, Daniel; Chirita, Vasile

    2015-01-01

    The modern treatment for alcohol dependence is still problematic, in many cases with the costs exceeding benefits. In these conditions a new management approach was developed lately, known as the systemic therapy. In this way, the crystallization and practical transposition of this new treatment approach is represented by the Clubs of Alcoholics in Treatment. These clubs are in fact a form of psycho-social intervention consisting of multi-family communities in order to maintain long-term abstinence from alcohol and to change their lifestyle and behavior. Thus, in the present paper we were interested in understanding the demographics of this systemic theory and how these aspects are influencing the final results of the therapy, as well as studying/confirming how relevant is this systemic approach on the management of alcohol dependence. Our results presented in this report bring additional evidences for the superiority of the systemic, multi-family approach of alcohol-related problems, as complemented to the standard medicinal therapy. Moreover, the data collected from patients in this study might suggest that patients with a higher educational level and therefore better capacity of understanding the information, with family support, and also with a better occupational insertion, have accepted to follow The Clubs of Alcoholics in Treatment program, with a subsequently better evolution. PMID:26793858

  19. Does sow reproduction and piglet performance benefit from the addition of n-3 polyunsaturated fatty acids to the maternal diet?

    PubMed

    Tanghe, Sofie; De Smet, Stefaan

    2013-09-01

    Good sow reproductive performance and piglet survival are essential for the profitability of the pig industry. Based on basic research of fatty acid and endocrine metabolism, it has been suggested that dietary supplementation with n-3 polyunsaturated fatty acids (PUFA) could enhance reproductive outcome. However, proper requirements for these nutrients in sow diets have not been established. This review examines the literature on the effect of n-3 PUFA in the maternal diet on sow reproduction and piglet performance. Few reported studies have included biochemical analyses, e.g. eicosanoid concentrations or gene expression data, which could help elucidate any link between dietary n-3 PUFA supplementation and reproduction. Additionally, most studies used relatively low numbers of pigs, limiting the validity of the conclusions which can be drawn. In pregnant pigs, supplementing with n-3 PUFA has not been shown to increase significantly the number of embryos (in gilts) or (in most studies) the total number of piglets born (live and/or stillborn), but may prolong gestation, although the literature is not consistent. Most studies found no effect of n-3 PUFA on piglet birth weight, although positive effects on piglet vitality and pre- and post-weaning growth have been reported. In contrast to the impact during pregnancy, low amounts of n-3 PUFA in the lactation diet may increase litter size in the subsequent gestation.

  20. 76 FR 1620 - Trials to Verify and Describe Clinical Benefit of Midodrine Hydrochloride; Establishment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-11

    ... to facilitate communication regarding the conduct of clinical trials needed to verify and describe...-threatening illnesses based on adequate and well-controlled clinical trials establishing that the drug has an... sponsored clinical trials and information regarding the drug's efficacy has been published, but...

  1. 'Makes you wanna do treatment': benefits of a hepatitis C specialist clinic to clients in Christchurch, New Zealand.

    PubMed

    Brener, Loren; Gray, Rebecca; Cama, Elena J; Treloar, Carla

    2013-03-01

    People with hepatitis C virus (HCV) are a marginalised population that may experience discrimination in everyday contexts, including health-care, due to the association of HCV with injecting drug use. Stigma and discrimination are known to have a range of negative effects on people with HCV, including diminished quality of life and avoidance of health-care. The Hepatitis C Community Clinic is an integrated care service established in 2008 in Christchurch, New Zealand to provide alternative access to health-care that is non-judgemental and supportive. As an integrated care service, the clinic aims to improve health outcomes and quality of life through a holistic approach to health-care for people with HCV and people who inject drugs. This qualitative study forms part of a broader mixed-methods evaluation of the clinic, and aims to assess the role of the clinic in improving health outcomes, knowledge, lifestyle practices and psychosocial functioning of the target population. Interviews were conducted with 24 health professionals and 24 clients of the clinic between April and November 2010. Findings illustrate that the clinic is a novel model of care that is effective in accessing a hard-to-reach and marginalised population in part due to the non-judgemental, caring and supportive environment that engenders trust with clients. Based on participant reports, the clinic assists clients in managing their HCV and other health concerns and in increasing their readiness for HCV treatment. Given the benefits of this community clinic to clients, it is proposed that future research investigate the feasibility and benefits of administering HCV treatment through community-based integrated care networks.

  2. Non-additive benefit or cost? Disentangling the indirect effects that occur when plants bearing extrafloral nectaries and honeydew-producing insects share exotic ant mutualists

    PubMed Central

    Savage, Amy M.; Rudgers, Jennifer A.

    2013-01-01

    Background and Aims In complex communities, organisms often form mutualisms with multiple different partners simultaneously. Non-additive effects may emerge among species linked by these positive interactions. Ants commonly participate in mutualisms with both honeydew-producing insects (HPI) and their extrafloral nectary (EFN)-bearing host plants. Consequently, HPI and EFN-bearing plants may experience non-additive benefits or costs when these groups co-occur. The outcomes of these interactions are likely to be influenced by variation in preferences among ants for honeydew vs. nectar. In this study, a test was made for non-additive effects on HPI and EFN-bearing plants resulting from sharing exotic ant guards. Preferences of the dominant exotic ant species for nectar vs. honeydew resources were also examined. Methods Ant access, HPI and nectar availability were manipulated on the EFN-bearing shrub, Morinda citrifolia, and ant and HPI abundances, herbivory and plant growth were assessed. Ant-tending behaviours toward HPI across an experimental gradient of nectar availability were also tracked in order to investigate mechanisms underlying ant responses. Key Results The dominant ant species, Anoplolepis gracilipes, differed from less invasive ants in response to multiple mutualists, with reductions in plot-wide abundances when nectar was reduced, but no response to HPI reduction. Conversely, at sites where A. gracilipes was absent or rare, abundances of less invasive ants increased when nectar was reduced, but declined when HPI were reduced. Non-additive benefits were found at sites dominated by A. gracilipes, but only for M. citrifolia plants. Responses of HPI at these sites supported predictions of the non-additive cost model. Interestingly, the opposite non-additive patterns emerged at sites dominated by other ants. Conclusions It was demonstrated that strong non-additive benefits and costs can both occur when a plant and herbivore share mutualist partners. These

  3. Identification, clinical distribution, and susceptibility to methicillin and 18 additional antibiotics of clinical Staphylococcus isolates: nationwide investigation in Italy.

    PubMed

    Varaldo, P E; Cipriani, P; Focá, A; Geraci, C; Giordano, A; Madeddu, M A; Orsi, A; Pompei, R; Prenna, M; Repetto, A

    1984-06-01

    A multicentric study of clinical Staphylococcus isolates was performed by seven operative units working in different areas of Italy. Over a 6-month period, a total of 3,226 staphylococci, isolated from in- and outpatients, were identified and tested for antimicrobial susceptibility by a protocol agreed upon by all units. On the basis of their bacteriolytic-activity patterns and other conventional tests, the isolates were identified by lyogroups , which closely correlate with human Staphylococcus species. Lyogroup I (Staphylococcus aureus) and lyogroup III (Staphylococcus capitis) were the most and the least frequently isolated staphylococci, respectively. Significant differences depending on strain origin from in- or outpatients were only observed with lyogroup IV (i.e., novobiocin- resistant staphylococci), whose isolation from outpatients was three times greater than from inpatients. Lyogroup I was predominant among isolates from most clinical sources. Lyogroup IV predominated in strains isolated from the urinary tract; lyogroup V (Staphylococcus epidermidis) predominated in strains from blood, cerebrospinal fluid, and indwelling artificial devices; and lyogroup VI ( Staphylococcus hominis, Staphylococcus haemolyticus, and Staphylococcus warneri ) predominated in strains from bile and the male genital tract. The incidence of methicillin resistance within the different lyogroups varied from unit to unit, suggesting epidemiological differences among different hospitals and different geographical areas. On the whole, methicillin resistance was more frequent in coagulase-negative staphylococci than in S. aureus and ranged from 19% for lyogroups I and III to 30% for lyogroup II (Staphylococcus simulans). Laboratory testing with 18 additional antibiotics suggested the occurrence of some specific differences in susceptibility among the different lyogroups . The rate of organisms resistant to the various antibiotics was greater among methicillin-resistant than among

  4. Identification, clinical distribution, and susceptibility to methicillin and 18 additional antibiotics of clinical Staphylococcus isolates: nationwide investigation in Italy.

    PubMed

    Varaldo, P E; Cipriani, P; Focá, A; Geraci, C; Giordano, A; Madeddu, M A; Orsi, A; Pompei, R; Prenna, M; Repetto, A

    1984-06-01

    A multicentric study of clinical Staphylococcus isolates was performed by seven operative units working in different areas of Italy. Over a 6-month period, a total of 3,226 staphylococci, isolated from in- and outpatients, were identified and tested for antimicrobial susceptibility by a protocol agreed upon by all units. On the basis of their bacteriolytic-activity patterns and other conventional tests, the isolates were identified by lyogroups , which closely correlate with human Staphylococcus species. Lyogroup I (Staphylococcus aureus) and lyogroup III (Staphylococcus capitis) were the most and the least frequently isolated staphylococci, respectively. Significant differences depending on strain origin from in- or outpatients were only observed with lyogroup IV (i.e., novobiocin- resistant staphylococci), whose isolation from outpatients was three times greater than from inpatients. Lyogroup I was predominant among isolates from most clinical sources. Lyogroup IV predominated in strains isolated from the urinary tract; lyogroup V (Staphylococcus epidermidis) predominated in strains from blood, cerebrospinal fluid, and indwelling artificial devices; and lyogroup VI ( Staphylococcus hominis, Staphylococcus haemolyticus, and Staphylococcus warneri ) predominated in strains from bile and the male genital tract. The incidence of methicillin resistance within the different lyogroups varied from unit to unit, suggesting epidemiological differences among different hospitals and different geographical areas. On the whole, methicillin resistance was more frequent in coagulase-negative staphylococci than in S. aureus and ranged from 19% for lyogroups I and III to 30% for lyogroup II (Staphylococcus simulans). Laboratory testing with 18 additional antibiotics suggested the occurrence of some specific differences in susceptibility among the different lyogroups . The rate of organisms resistant to the various antibiotics was greater among methicillin-resistant than among

  5. Patients With Proneural Glioblastoma May Derive Overall Survival Benefit From the Addition of Bevacizumab to First-Line Radiotherapy and Temozolomide: Retrospective Analysis of the AVAglio Trial

    PubMed Central

    Sandmann, Thomas; Bourgon, Richard; Garcia, Josep; Li, Congfen; Cloughesy, Timothy; Chinot, Olivier L.; Wick, Wolfgang; Nishikawa, Ryo; Mason, Warren; Henriksson, Roger; Saran, Frank; Lai, Albert; Moore, Nicola; Kharbanda, Samir; Peale, Franklin; Hegde, Priti; Abrey, Lauren E.; Phillips, Heidi S.; Bais, Carlos

    2015-01-01

    Purpose The AVAglio (Avastin in Glioblastoma) and RTOG-0825 randomized, placebo-controlled phase III trials in newly diagnosed glioblastoma reported prolonged progression-free survival (PFS), but not overall survival (OS), with the addition of bevacizumab to radiotherapy plus temozolomide. To establish whether certain patient subgroups derived an OS benefit from the addition of bevacizumab to first-line standard-of-care therapy, AVAglio patients were retrospectively evaluated for molecular subtype, and bevacizumab efficacy was assessed for each patient subgroup. Patients and Methods A total of 349 pretreatment specimens (bevacizumab arm, n = 171; placebo arm, n = 178) from AVAglio patients (total, N = 921) were available for biomarker analysis. Samples were profiled for gene expression and isocitrate dehydrogenase 1 (IDH1) mutation status and classified into previously identified molecular subtypes. PFS and OS were assessed within each subtype. Results A multivariable analysis accounting for prognostic covariates revealed that bevacizumab conferred a significant OS advantage versus placebo for patients with proneural IDH1 wild-type tumors (17.1 v 12.8 months, respectively; hazard ratio, 0.43; 95% CI, 0.26 to 0.73; P = .002). This analysis also revealed an interaction between the proneural subtype biomarker and treatment arm (P = .023). The group of patients with mesenchymal and proneural tumors derived a PFS benefit from bevacizumab compared with placebo; however, this translated to an OS benefit in the proneural subset only. Conclusion Retrospective analysis of AVAglio data suggests that patients with IDH1 wild-type proneural glioblastoma may derive an OS benefit from first-line bevacizumab treatment. The predictive value of the proneural subtype observed in AVAglio should be validated in an independent data set. PMID:26124478

  6. Analysis, sample size, and power for estimating incremental net health benefit from clinical trial data.

    PubMed

    Willan, A R

    2001-06-01

    Stinnett and Mullahy recently introduced the concept of net health benefit as an alternative to cost-effectiveness ratios for the statistical analysis of patient-level data on the costs and health effects of competing interventions. Net health benefit addresses a number of problems associated with cost-effectiveness ratios by assuming a value for the willingness-to-pay for a unit of effectiveness. We extend the concept of net health benefit to demonstrate that standard statistical procedures can be used for the analysis, power, and sample size determinations of cost-effectiveness data. We also show that by varying the value of the willingness-to-pay, the point estimate and confidence interval for the incremental cost-effectiveness ratio can be determined. An example is provided.

  7. CTLA-4 blockade enhances polyfunctional NY-ESO-1 specific T cell responses in metastatic melanoma patients with clinical benefit.

    PubMed

    Yuan, Jianda; Gnjatic, Sacha; Li, Hao; Powel, Sarah; Gallardo, Humilidad F; Ritter, Erika; Ku, Geoffrey Y; Jungbluth, Achim A; Segal, Neil H; Rasalan, Teresa S; Manukian, Gregor; Xu, Yinyan; Roman, Ruth-Ann; Terzulli, Stephanie L; Heywood, Melanie; Pogoriler, Evelina; Ritter, Gerd; Old, Lloyd J; Allison, James P; Wolchok, Jedd D

    2008-12-23

    Blockade of inhibitory signals mediated by cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) has been shown to enhance T cell responses and induce durable clinical responses in patients with metastatic melanoma. The functional impact of anti-CTLA-4 therapy on human immune responses is still unclear. To explore this, we analyzed immune-related adverse events and immune responses in metastatic melanoma patients treated with ipilimumab, a fully human anti-CTLA-4 monoclonal antibody. Fifteen patients were selected on the basis of availability of suitable specimens for immunologic monitoring, and eight of these showed evidence of clinical benefit. Five of the eight patients with evidence of clinical benefit had NY-ESO-1 antibody, whereas none of seven clinical non-responders was seropositive for NY-ESO-1. All five NY-ESO-1 seropositive patients had clearly detectable CD4(+) and CD8(+) T cells against NY-ESO-1 following treatment with ipilimumab. One NY-ESO-1 seronegative clinical responder also had a NY-ESO-1 CD4(+) and CD8(+) T cell response, possibly related to prior vaccination with NY-ESO-1. Among five clinical non-responders analyzed, only one had a NY-ESO-1 CD4(+) T cell response and this patient did not have detectable anti-NY-ESO-1 antibody. Overall, NY-ESO-1-specific T cell responses increased in frequency and functionality during anti-CTLA-4 treatment, revealing a polyfunctional response pattern of IFN-gamma, MIP-1beta and TNF-alpha. We therefore suggest that CTLA-4 blockade enhanced NY-ESO-1 antigen-specific B cell and T cell immune responses in patients with durable objective clinical responses and stable disease. These data provide an immunologic rationale for the efficacy of anti-CTLA-4 therapy and call for immunotherapeutic designs that combine NY-ESO-1 vaccination with CTLA-4 blockade.

  8. A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence

    PubMed Central

    Anding, Kirsten; Bär, Thomas; Trojniak-Hennig, Joanna; Kuchinke, Simone; Krause, Rolfdieter; Rost, Jan M; Halle, Martin

    2015-01-01

    Objective Long-term studies regarding the effect of a structured physical exercise programme (SPEP) during haemodialysis (HD) assessing compliance and clinical benefit are scarce. Study design A single-centre clinical trial, non-randomised, investigating 46 patients with HD (63.2±16.3 years, male/female 24/22, dialysis vintage 4.4 years) performing an SPEP over 5 years. The SPEP (twice/week for 60 min during haemodialysis) consisted of a combined resistance (8 muscle groups) and endurance (supine bicycle ergometry) training. Exercise intensity was continuously adjusted to improvements of performance testing. Changes in endurance and resistance capacity, physical functioning and quality of life (QoL) were analysed over 1 year in addition to long-term adherence and economics of the programme over 5 years. Average power per training session, maximal strength tests (maximal exercise repetitions/min), three performance-based tests for physical function, SF36 for QoL were assessed in the beginning and every 6 months thereafter. Results 78% of the patients completed the programme after 1 year and 43% after 5 years. Participants were divided—according to adherence to the programme—into three groups: (1) high adherence group (HA, >80% of 104 training sessions within 12 months), (2) moderate adherence (MA, 60–80%), and 3. Low adherence group (LA, <60%)) with HA and MA evaluated quantitatively. One-year follow-up data revealed significant (p<0.05) improvement for both groups in all measured parameters: exercise capacity (HA: 55%, MA: 45%), strength (HA: >120%, MA: 40–50%), QoL in three scores of SF36 subscales and physical function in the three tests taken between 11% and 31%. Moreover, a quantitative correlation analysis revealed a close association (r=0.8) between large improvement of endurance capacity and weak physical condition (HA). Conclusions The exercise programme described improves physical function significantly and can be integrated

  9. Addition of meloxicam to the treatment of clinical mastitis improves subsequent reproductive performance.

    PubMed

    McDougall, S; Abbeloos, E; Piepers, S; Rao, A S; Astiz, S; van Werven, T; Statham, J; Pérez-Villalobos, N

    2016-03-01

    A blinded, negative controlled, randomized intervention study was undertaken to test the hypothesis that addition of meloxicam, a nonsteroidal anti-inflammatory drug, to antimicrobial treatment of mild to moderate clinical mastitis would improve fertility and reduce the risk of removal from the herd. Cows (n=509) from 61 herds in 8 regions (sites) in 6 European countries were enrolled. Following herd-owner diagnosis of mild to moderate clinical mastitis within the first 120 d of lactation in a single gland, the rectal temperature, milk appearance, and California Mastitis Test score were assessed. Cows were randomly assigned within each site to be treated either with meloxicam or a placebo (control). All cows were additionally treated with 1 to 4 intramammary infusions of cephalexin and kanamycin at 24-h intervals. Prior to treatment and at 14 and 21 d posttreatment, milk samples were collected for bacteriology and somatic cell count. Cows were bred by artificial insemination and pregnancy status was subsequently defined. General estimating equations were used to determine the effect of treatment (meloxicam versus control) on bacteriological cure, somatic cell count, the probability of being inseminated by 21 d after the voluntary waiting period, the probability of conception to first artificial insemination, the number of artificial insemination/conception, the probability of pregnancy by 120 or 200 d postcalving, and the risk of removal by 300 d after treatment. Cox's proportional hazards models were used to test the effect of treatment on the calving to first insemination and calving to conception intervals. Groups did not differ in terms of age, clot score, California Mastitis Test score, rectal temperature, number of antimicrobial treatments given or bacteria present at the time of enrollment, but cows treated with meloxicam had greater days in milk at enrollment. Cows treated with meloxicam had a higher bacteriological cure proportion than those treated with

  10. Addition of meloxicam to the treatment of clinical mastitis improves subsequent reproductive performance.

    PubMed

    McDougall, S; Abbeloos, E; Piepers, S; Rao, A S; Astiz, S; van Werven, T; Statham, J; Pérez-Villalobos, N

    2016-03-01

    A blinded, negative controlled, randomized intervention study was undertaken to test the hypothesis that addition of meloxicam, a nonsteroidal anti-inflammatory drug, to antimicrobial treatment of mild to moderate clinical mastitis would improve fertility and reduce the risk of removal from the herd. Cows (n=509) from 61 herds in 8 regions (sites) in 6 European countries were enrolled. Following herd-owner diagnosis of mild to moderate clinical mastitis within the first 120 d of lactation in a single gland, the rectal temperature, milk appearance, and California Mastitis Test score were assessed. Cows were randomly assigned within each site to be treated either with meloxicam or a placebo (control). All cows were additionally treated with 1 to 4 intramammary infusions of cephalexin and kanamycin at 24-h intervals. Prior to treatment and at 14 and 21 d posttreatment, milk samples were collected for bacteriology and somatic cell count. Cows were bred by artificial insemination and pregnancy status was subsequently defined. General estimating equations were used to determine the effect of treatment (meloxicam versus control) on bacteriological cure, somatic cell count, the probability of being inseminated by 21 d after the voluntary waiting period, the probability of conception to first artificial insemination, the number of artificial insemination/conception, the probability of pregnancy by 120 or 200 d postcalving, and the risk of removal by 300 d after treatment. Cox's proportional hazards models were used to test the effect of treatment on the calving to first insemination and calving to conception intervals. Groups did not differ in terms of age, clot score, California Mastitis Test score, rectal temperature, number of antimicrobial treatments given or bacteria present at the time of enrollment, but cows treated with meloxicam had greater days in milk at enrollment. Cows treated with meloxicam had a higher bacteriological cure proportion than those treated with

  11. Influence of an alloy addition on the physical and clinical behaviour of glass ionomer cement

    NASA Astrophysics Data System (ADS)

    Abour, Mohamed Abour Bashir

    These in vitro studies compared the various properties of an experimental high powder liquid content glass ionomer cement (EXPT) with those of a metal addition GIC (Hi-Dense) and disperse phase amalgam (Dispersalloy). Bi-axial, four point flexural and compressive tests were used to evaluate strength. Six groups of ten specimens were constructed for each test for each material and allowed to set in an oven at 37°C for 60 minutes. Specimens were stored in distilled water at 37°C until testing at one day, one week, one, three, six months and year. It was found that the strength of Hi-Dense increased and then maintained over extended time, whereas the strength of EXPT showed a declined at 3 months. The bond strengths of the materials to both enamel and dentine were also evaluated. Ten groups of ten teeth, five for each surface for each glass ionomer materials, were prepared. Teeth were aligned leaving the enamel and dentine surfaces exposed. The mixed material was condensed into a cylinder placed on the appropriate surface. These specimens were also stored in distilled water at 37°C. It was found that Hi-Dense had a higher bond strength to enamel that increased with time. The bond strength to dentine was maintained over the test period. The erosion rate of the materials was evaluated using the lactic acid erosion test. Three groups of six specimens for each material were constructed and tested after one hour, one day and at six months. Each specimen was subjected to an impinging jet of lactic acid solution. The erosion rate was determined by weight loss and dimensional change. It was found that Hi-Dense had a high erosion resistance which was slightly better than the experimental material. The microleakage, around restorations prepared, using the glass ionomer materials, was evaluated after cyclical loading the restoration-tooth complex. It was found that there was less leakage around Hi-Dense than EXPT at both the cervical and occlusal margins. In a clinical

  12. Worms as therapeutic agents for allergy and asthma: understanding why benefits in animal studies have not translated into clinical success.

    PubMed

    Evans, Holly; Mitre, Edward

    2015-02-01

    Helminth infections are associated with decreased rates of autoimmunity and allergy, and several clinical studies have demonstrated that intentional infection with helminths can reduce symptoms of autoimmune diseases. In contrast, though numerous animal studies have demonstrated that helminth infections ameliorate allergic diseases, clinical trials in humans have not shown benefit. In this article, we review in detail the 2 human studies that have prospectively tested whether helminth infections protect against allergy. We next review the research designs and results obtained from animal studies, and compare these to the human trials. We then postulate possible reasons for the lack of efficacy observed in clinical trials to date and discuss potential future areas of research in this field.

  13. Clinical Observations About the Potential Benefits and Pitfalls of Between-Session Contacts with Borderline Patients.

    PubMed

    Jacob, Karen L

    2016-01-01

    Borderline Personality Disorder (BPD) has a reputation for being a challenging disorder to treat due to the nature of the illness. With the development of evidence-based treatments, therapists are becoming more skilled at successfully helping this cohort of patients. A common factor associated with all validated treatments for BPD is the active involvement of therapists. For example, DBT is one treatment where therapists are expected to be available to patients for coaching outside of sessions. However, understanding the benefits and pitfalls associated with therapists' accessibility in between sessions is relevant to any treatment with intersession contact. In this article, three benefits of intersession contact are described: to generalize the use of skills, to improve understanding of the patient's needs, and to facilitate an alliance. This article also addresses the pitfalls of therapists being so accessible to patients. Both the benefits and pitfalls of intersession contact are illustrated using case vignettes. Assessing the function served by a patient's contact in between sessions is an important way to determine whether such contact is a productive part of treatment. Recommendations are provided to avoid detrimental outcomes for both the therapist (therapist burnout) and the patient. PMID:27603746

  14. Clinical benefits of tight glycaemic control: focus on the perioperative setting.

    PubMed

    Furnary, Anthony P

    2009-12-01

    The benefits of tight glycaemic control (TGC) were first shown in cardiac surgical patients with diabetes. These concepts migrated to other surgical and medical specialties through intensive care units caring for a variety of patients with a variety of disease states Although some disagreement and controversy surrounds the use of TGC in the medical population, the benefits of this therapy ir the diabetes cardiac surgery population is unblemished. Perioperative hyperglycaemia has been shown to be associated with adverse surgical outcomes in several different patient populations TGC for 3 full postoperative days or more mitigates these risks Although this has been definitively proven in the diabetes coronary artery bypass graft (CABG) population, evidence for beneficia effects of TGC in other surgical populations remains elusive at this point in time. In this article, we explore the risks of hyper- and hypoglycaemia in the surgical patient; safety and efficacy of insulin protocols in the surgical population, target range goals and dura tion of therapy; the beneficial effects of TGC on decreasing mortality, reducing infectious complications, length of stay and other complications; define target surgical populations tha benefit from TGC; analyse current controversies as they relate to surgical populations; and describe questions that remain for the future of TGC.

  15. Weighing the evidence: risks and benefits of participatory documentary in corporatized clinics.

    PubMed

    Hansen, Helena

    2013-12-01

    This paper describes the effects of one U.S.-based public psychiatry clinic's shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on "evidence based" treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends. PMID:23932854

  16. Weighing the evidence: risks and benefits of participatory documentary in corporatized clinics.

    PubMed

    Hansen, Helena

    2013-12-01

    This paper describes the effects of one U.S.-based public psychiatry clinic's shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on "evidence based" treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends.

  17. Comprehensive cancer-gene panels can be used to estimate mutational load and predict clinical benefit to PD-1 blockade in clinical practice.

    PubMed

    Campesato, Luís Felipe; Barroso-Sousa, Romualdo; Jimenez, Leandro; Correa, Bruna R; Sabbaga, Jorge; Hoff, Paulo M; Reis, Luiz F L; Galante, Pedro Alexandre F; Camargo, Anamaria A

    2015-10-27

    Cancer gene panels (CGPs) are already used in clinical practice to match tumor's genetic profile with available targeted therapies. We aimed to determine if CGPs could also be applied to estimate tumor mutational load and predict clinical benefit to PD-1 and CTLA-4 checkpoint blockade therapy. Whole-exome sequencing (WES) mutation data obtained from melanoma and non-small cell lung cancer (NSCLC) patients published by Snyder et al. 2014 and Rizvi et al. 2015, respectively, were used to select nonsynonymous somatic mutations occurring in genes included in the Foundation Medicine Panel (FM-CGP) and in our own Institutional Panel (HSL-CGP). CGP-mutational load was calculated for each patient using both panels and was associated with clinical outcomes as defined and reported in the original articles. Higher CGP-mutational load was observed in NSCLC patients presenting durable clinical benefit (DCB) to PD-1 blockade (FM-CGP P=0.03, HSL-CGP P=0.01). We also observed that 69% of patients with high CGP-mutational load experienced DCB to PD-1 blockade, as compared to 20% of patients with low CGP-mutational load (FM-CGP and HSL-CGP P=0.01). Noteworthy, predictive accuracy of CGP-mutational load for DCB was not statistically different from that estimated by WES sequencing (P=0.73). Moreover, a high CGP-mutational load was significantly associated with progression-free survival (PFS) in patients treated with PD-1 blockade (FM-CGP P=0.005, HR 0.27, 95% IC 0.105 to 0.669; HSL-CGP P=0.008, HR 0.29, 95% IC 0.116 to 0.719). Similar associations between CGP-mutational load and clinical benefit to CTLA-4 blockade were not observed. In summary, our data reveals that CGPs can be used to estimate mutational load and to predict clinical benefit to PD-1 blockade, with similar accuracy to that reported using WES. PMID:26439694

  18. Comprehensive cancer-gene panels can be used to estimate mutational load and predict clinical benefit to PD-1 blockade in clinical practice

    PubMed Central

    Campesato, Luís Felipe; Barroso-Sousa, Romualdo; Jimenez, Leandro; Correa, Bruna R.; Sabbaga, Jorge; Hoff, Paulo M.; Reis, Luiz F. L.; Galante, Pedro Alexandre F.; Camargo, Anamaria A.

    2015-01-01

    Cancer gene panels (CGPs) are already used in clinical practice to match tumor's genetic profile with available targeted therapies. We aimed to determine if CGPs could also be applied to estimate tumor mutational load and predict clinical benefit to PD-1 and CTLA-4 checkpoint blockade therapy. Whole-exome sequencing (WES) mutation data obtained from melanoma and non-small cell lung cancer (NSCLC) patients published by Snyder et al. 2014 and Rizvi et al. 2015, respectively, were used to select nonsynonymous somatic mutations occurring in genes included in the Foundation Medicine Panel (FM-CGP) and in our own Institutional Panel (HSL-CGP). CGP-mutational load was calculated for each patient using both panels and was associated with clinical outcomes as defined and reported in the original articles. Higher CGP-mutational load was observed in NSCLC patients presenting durable clinical benefit (DCB) to PD-1 blockade (FM-CGP P=0.03, HSL-CGP P=0.01). We also observed that 69% of patients with high CGP-mutational load experienced DCB to PD-1 blockade, as compared to 20% of patients with low CGP-mutational load (FM-CGP and HSL-CGP P=0.01). Noteworthy, predictive accuracy of CGP-mutational load for DCB was not statistically different from that estimated by WES sequencing (P=0.73). Moreover, a high CGP-mutational load was significantly associated with progression-free survival (PFS) in patients treated with PD-1 blockade (FM-CGP P=0.005, HR 0.27, 95% IC 0.105 to 0.669; HSL-CGP P=0.008, HR 0.29, 95% IC 0.116 to 0.719). Similar associations between CGP-mutational load and clinical benefit to CTLA-4 blockade were not observed. In summary, our data reveals that CGPs can be used to estimate mutational load and to predict clinical benefit to PD-1 blockade, with similar accuracy to that reported using WES. PMID:26439694

  19. Clinical effect of additional electroacupuncture on thoracolumbar intervertebral disc herniation in 80 paraplegic dogs.

    PubMed

    Han, Hyun-Jung; Yoon, Hun-Young; Kim, Joon-Young; Jang, Ha-Young; Lee, Bora; Choi, Seok Hwa; Jeong, Soon-Wuk

    2010-01-01

    The clinical efficacy of electroacupuncture and acupuncture in combination with medication for the treatment of thoracolumbar intervertebral disc herniation was investigated in paraplegic dogs with intact deep pain perception. To evaluate the additional effect of electroacupuncture, dogs treated with conventional medicines alone were compared to dogs treated with electroacupuncture and acupuncture and conventional medicine. Medical records of 80 dogs were reviewed for this investigation and classified into two groups undergoing different treatment methods: (1) treatment with conventional medicine alone (Group C, n = 37) and (2) treatment with conventional medicine combined with electroacupuncture and acupuncture (Group CE, n = 43). Prednisone was the conventional medicine and electroacupuncture was applied at GV07 and GV02-1 at 0.5-2.5 mV, mixed Hz of 2 and 15 Hz for 25-30 min. Acupuncture was performed locally at urinary bladder meridian points near the lesion, and bilaterally distantly at GB30, GB34, and ST36. Treatment efficacy was evaluated by post-operative neurologic function, ambulation, relapse, complication, and urinary function. Ambulation recovery was more prevalent in Group CE than Group C (p = 0.01) and recovery of ambulation and back pain relief time was shorter in Group CE compared to Group C (p = 0.011 and 0.001, respectively). Relapse rate was significantly lower in Group CE (p = 0.031). The results suggest that a combination of electroacupuncture and acupuncture with conventional medicine is more effective than conventional medicine alone in recovering ambulation, relieving back pain, and decreasing relapse. Electroacupuncture and acupuncture is thus a reasonable option for the treatment of intervertebral disc herniation in paraplegic dogs with intact deep pain perception. PMID:21061457

  20. SMARCE1, a rare cause of Coffin-Siris Syndrome: Clinical description of three additional cases.

    PubMed

    Zarate, Yuri A; Bhoj, Elizabeth; Kaylor, Julie; Li, Dong; Tsurusaki, Yoshinori; Miyake, Noriko; Matsumoto, Naomichi; Phadke, Shubha; Escobar, Luis; Irani, Afifa; Hakonarson, Hakon; Schrier Vergano, Samantha A

    2016-08-01

    Coffin-Siris syndrome (CSS, MIM 135900), is a well-described, multiple congenital anomaly syndrome characterized by coarse facial features, hypertrichosis, sparse scalp hair, and hypo/aplastic digital nails and phalanges, typically of the 5th digits. Mutations in the BAF (SWI/SNF)-complex subunits (SMARCA4, SMARCE1, SMARCB1, SMARCA2, ARID1B, and ARID1A) have been shown to cause not only CSS, but also related disorders including Nicolaides-Baraitser (MIM 601358) syndrome and ARID1B-intellectual disability syndrome (MIM 614562). At least 200 individuals with CSS have been found to have a mutation in the BAF pathway. However, to date, only three individuals with CSS have been reported to have pathogenic variants in SMARCE1. We report here three additional individuals with clinical features consistent with CSS and alterations in SMARCE1, one of which is novel. The probands all exhibited dysmorphic facial features, moderate developmental and cognitive delay, poor growth, and hypoplastic digital nails/phalanges, including digits not typically affected in the other genes associated with CSS. Two of the three probands had a variety of different organ system anomalies, including cardiac disease, genitourinary abnormalities, feeding difficulties, and vision abnormalities. The 3rd proband has not had further investigative studies. Although an increasing number of individuals are being diagnosed with disorders in the BAF pathway, SMARCE1 is the least common of these genes. This report doubles the number of probands with these mutations, and allows for better phenotypic information of this rare syndrome. © 2016 Wiley Periodicals, Inc. PMID:27264197

  1. Weighing the evidence: Risks and benefits of participatory documentary in corporatized clinics

    PubMed Central

    Hansen, Helena

    2014-01-01

    This paper describes the effects of one U.S.-based public psychiatry clinic’s shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on “evidence based” treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends. PMID:23932854

  2. No Additional Benefit of Repeat-Sprint Training in Hypoxia than in Normoxia on Sea-Level Repeat-Sprint Ability

    PubMed Central

    Goods, Paul S.R.; Dawson, Brian; Landers, Grant J.; Gore, Christopher J.; Peeling, Peter

    2015-01-01

    To assess the impact of ‘top-up’ normoxic or hypoxic repeat-sprint training on sea-level repeat-sprint ability, thirty team sport athletes were randomly split into three groups, which were matched in running repeat-sprint ability (RSA), cycling RSA and 20 m shuttle run performance. Two groups then performed 15 maximal cycling repeat-sprint training sessions over 5 weeks, in either normoxia (NORM) or hypoxia (HYP), while a third group acted as a control (CON). In the post-training cycling RSA test, both NORM (13.6%; p = 0.0001, and 8.6%; p = 0.001) and HYP (10.3%; p = 0.007, and 4.7%; p = 0.046) significantly improved overall mean and peak power output, respectively, whereas CON did not change (1.4%; p = 0.528, and -1.1%; p = 0.571, respectively); with only NORM demonstrating a moderate effect for improved mean and peak power output compared to CON. Running RSA demonstrated no significant between group differences; however, the mean sprint times improved significantly from pre- to post-training for CON (1.1%), NORM (1.8%), and HYP (2.3%). Finally, there were no group differences in 20 m shuttle run performance. In conclusion, ‘top-up’ training improved performance in a task-specific activity (i.e. cycling); however, there was no additional benefit of conducting this ‘top-up’ training in hypoxia, since cycle RSA improved similarly in both HYP and NORM conditions. Regardless, the ‘top-up’ training had no significant impact on running RSA, therefore the use of cycle repeat-sprint training should be discouraged for team sport athletes due to limitations in specificity. Key points ‘Top-up’ repeat-sprint training performed on a cycle ergometer enhances cycle repeat-sprint ability compared to team sport training only in football players. The addition of moderate hypoxia to repeat-sprint training provides no additional performance benefits to sea-level repeat-sprint ability or endurance performance than normoxic repeat-sprint training.

  3. No Additional Benefit of Repeat-Sprint Training in Hypoxia than in Normoxia on Sea-Level Repeat-Sprint Ability.

    PubMed

    Goods, Paul S R; Dawson, Brian; Landers, Grant J; Gore, Christopher J; Peeling, Peter

    2015-09-01

    To assess the impact of 'top-up' normoxic or hypoxic repeat-sprint training on sea-level repeat-sprint ability, thirty team sport athletes were randomly split into three groups, which were matched in running repeat-sprint ability (RSA), cycling RSA and 20 m shuttle run performance. Two groups then performed 15 maximal cycling repeat-sprint training sessions over 5 weeks, in either normoxia (NORM) or hypoxia (HYP), while a third group acted as a control (CON). In the post-training cycling RSA test, both NORM (13.6%; p = 0.0001, and 8.6%; p = 0.001) and HYP (10.3%; p = 0.007, and 4.7%; p = 0.046) significantly improved overall mean and peak power output, respectively, whereas CON did not change (1.4%; p = 0.528, and -1.1%; p = 0.571, respectively); with only NORM demonstrating a moderate effect for improved mean and peak power output compared to CON. Running RSA demonstrated no significant between group differences; however, the mean sprint times improved significantly from pre- to post-training for CON (1.1%), NORM (1.8%), and HYP (2.3%). Finally, there were no group differences in 20 m shuttle run performance. In conclusion, 'top-up' training improved performance in a task-specific activity (i.e. cycling); however, there was no additional benefit of conducting this 'top-up' training in hypoxia, since cycle RSA improved similarly in both HYP and NORM conditions. Regardless, the 'top-up' training had no significant impact on running RSA, therefore the use of cycle repeat-sprint training should be discouraged for team sport athletes due to limitations in specificity. Key points'Top-up' repeat-sprint training performed on a cycle ergometer enhances cycle repeat-sprint ability compared to team sport training only in football players.The addition of moderate hypoxia to repeat-sprint training provides no additional performance benefits to sea-level repeat-sprint ability or endurance performance than normoxic repeat-sprint training.'Top-up' cycling repeat-sprint training

  4. Innovations in Total Knee Arthroplasty: Improved Technical Precision, But Unclear Clinical Benefits.

    PubMed

    Keeney, James A

    2016-07-01

    Total knee arthroplasty has been an effective treatment for advanced degenerative joint disease. Traditional knee designs and surgical approaches have resulted in consistently high performance, but some patients may remain dissatisfied after their surgery. Several surgical innovations, including accelerometer-based navigation, patient-specific instrumentation, and robotic-assisted total knee arthroplasty, have been developed to improve the accuracy and precision of total knee arthroplasty surgery, with anticipated secondary benefits of improved functional outcomes and implant survivorship. This article reviews the current status of these technologies as reported in contemporary orthopedic literature. [Orthopedics. 2016; 39(4):217-220.]. PMID:27434889

  5. Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal.

    PubMed

    Lerner, Herbert; Whang, Joyce; Nipper, Rebecca

    2013-03-01

    Diet and exercise, except in controlled circumstances, have not been shown to provide effective and prolonged weight loss for the majority of those who are obese. Several older drugs intended to reduce weight have been withdrawn from the market, and the new drugs show only modest weight loss. Surgical intervention, specifically procedures that alter the normal gastrointestinal anatomy, does provide prolonged periods of sustained weight loss, with rebound weight gain over time. A variety of medical devices to assist in weight reduction have been studied, but only two are legally marketed devices for obesity. The authors propose a new paradigm for devices intended to treat obesity, based on a benefit-risk determination, with the hope to provide sponsors an a priori tool for systematic assessment of the risks associated with the devices intended for treatment of obesity and to suggest appropriate levels of benefit for devices with different risk levels. The paradigm is not intended to determine the class of a device from a regulatory perspective. This approach was conceived at a Food and Drug Administration (FDA) co-sponsored workshop in October, 2011 and formally presented to an FDA advisory panel for discussion in May 2012.

  6. Clinical benefits and immunopathological correlates of intravenous immune globulin in the treatment of inflammatory myopathies.

    PubMed

    Dalakas, M C

    1996-05-01

    High-dose intravenous immune globulin (IVIG) is emerging as a promising therapy for patients with inflammatory myopathies who have become unresponsive to, or cannot tolerate, conventional therapies. In a double-blind, placebo-controlled study, using objective criteria for improvement, IVIG demonstrated moderate to dramatic improvement in 75% of the patients with dermatomyositis. Preliminary results from a controlled study in inclusion-body myositis show that IVIG may also exert a mild benefit, but only in a small number of patients and in certain muscle groups. In some patients with polymyositis, IVIG is reported to be of benefit but controlled studies have not yet been completed. Immunocytochemical, immunological and in vitro studies on the patients' repeated muscle biopsies and follow-up sera showed that IVIG exerts its action in inflammatory myopathies by: (i) inhibiting myotoxic cytokines, such as TNF-alpha and IL-1; (ii) blockade of Fc receptors on endomysial macrophages interfering with Fc receptor-mediated phagocytosis; and (iii) inhibiting the uptake of C3 and intercepting the formation and deposition of membranolytic attack complex on the endomysial capillaries.

  7. Cardiovascular benefits of probiotics: a review of experimental and clinical studies.

    PubMed

    Thushara, Ram Mohan; Gangadaran, Surendiran; Solati, Zahra; Moghadasian, Mohammed H

    2016-02-01

    The microbiota inhabiting the human gastro-intestinal tract is reported to have a significant impact on the health of an individual. Recent findings suggest that the microbial imbalance of the gut may play a role in pathogenesis of cardiovascular diseases (CVD). Therefore, several studies have delved into the aspect of altering gut microbiota with probiotics as an approach to prevent and/or treat CVD. The World Health Organization defines probiotics as live microorganisms that, when consumed in adequate amounts, have a positive influence on the individual's health. The present review focuses on strategies of human dietary intervention with probiotic strains and their impact on cardiovascular risk factors like hypercholesterolemia, hypertension, obesity and type-2 diabetes. Accumulating evidence shows probiotics to lower low density lipoproteins (LDL)-cholesterol and improve the LDL/high density lipoproteins (HDL) ratio, as well as lower blood pressure, inflammatory mediators, blood glucose levels and body mass index. Thus, probiotics have the scope to be developed as dietary supplements with potential cardiovascular health benefits. However, there is not only ambiguity regarding the exact strains and dosages of the probiotics that will bring about positive health effects, but also factors like immunity and genetics of the individual that might influence the efficacy of probiotics. Therefore, further studies are required not only to understand the mechanisms by which probiotics may beneficially affect the cardiovascular system, but also to rule out any of their probable negative effects on health. The present review aims to critically appraise the complexity of the available data with regard to the cardiovascular benefits of probiotics. PMID:26786971

  8. Review of endoscopic radiofrequency in biliopancreatic tumours with emphasis on clinical benefits, controversies and safety

    PubMed Central

    Alvarez-Sánchez, María-Victoria; Napoléon, Bertrand

    2016-01-01

    Most pancreatic cancers and extrahepatic cholangiocarcinomas are unresectable at the time of diagnosis, and even in case of a resectable cancer, for elderly or patients with coexistent comorbidities, surgery is not an option. Current treatment alternatives in these scenarios are very limited. Biliary stenting with self-expanding metal stents (SEMS) is the mainstay palliative treatment of biliary obstruction due to unresectable pancreatic cancer or cholangiocarcinoma. Nevertheless, more than 50% of SEMS become occluded after 6 mo due to tumour over- and ingrowth, leading to hospital readmissions and reinterventions that significantly impair quality of life. Regimes of chemotherapy or chemoradiotherapy also provide minimal survival benefits. Therefore, novel therapies are eagerly awaited. Radiofrequency (RF) energy causes coagulative necrosis leading to local destruction of the accessed malignant tissue and has an established role in the treatment of malignancies in several solid organs, especially liver cancers. However, pancreatic and extrahepatic biliary cancers are not easily accessed by a percutaneous route, making the procedure dangerous. Over the past five years, the development of dedicated devices compatible with endoscopic instruments has offered a minimally invasive option for RF energy delivery in biliopancreatic cancers. Emerging experience with endoscopic RF ablation (RFA) in this setting has been reported in the literature, but little is known about its feasibility, efficacy and safety. A literature review makes it clear that RFA in biliopancreatic tumours is feasible with high rates of technical success and acceptable safety profile. Although available data suggest a benefit of survival with RFA, there is not enough evidence to draw a firm conclusion about its efficacy. For this reason, prospective randomized trials comparing RFA with standard palliative treatments with quality-of-life and survival endpoints are required. Anecdotal reports have also

  9. Prolonged clinical benefit of everolimus therapy in the management of high-grade pancreatic neuroendocrine carcinoma.

    PubMed

    Fonseca, Paula J; Uriol, Esther; Galván, José A; Alvarez, Carlos; Pérez, Quionia; Villanueva, Noemi; Berros, José P; Izquierdo, Marta; Viéitez, José M

    2013-01-01

    Treatment options for patients with high-grade pancreatic neuroendocrine tumors (pNET) are limited, especially for those with progressive disease and for those who experience treatment failure. Everolimus, an oral inhibitor of mammalian target of rapamycin (mTOR), has been approved for the treatment of patients with low- or intermediate-grade advanced pNET. In the randomized phase III RADIANT-3 study in patients with low- or intermediate-grade advanced pNET, everolimus significantly increased progression-free survival (PFS) and decreased the relative risk for disease progression by 65% over placebo. This case report describes a heavily pretreated patient with high-grade pNET and liver and peritoneal metastases who achieved prolonged PFS, clinically relevant partial radiologic tumor response, and resolution of constitutional symptoms with improvement in Karnofsky performance status while receiving a combination of everolimus and octreotide long-acting repeatable (LAR). Radiologic and clinical responses were maintained for 19 months, with minimal toxicity over the course of treatment. This case supports the findings that the combination of everolimus plus octreotide LAR may be considered for use in patients with high-grade pNET and progressive disease. Although behavior and aggressiveness are different between low- or intermediate-grade and high-grade pNET, some high-grade pNET may express mTOR; hence, everolimus should be considered in a clinical trial.

  10. Prolonged Clinical Benefit of Everolimus Therapy in the Management of High-Grade Pancreatic Neuroendocrine Carcinoma

    PubMed Central

    Fonseca, Paula J.; Uriol, Esther; Galván, José A.; Álvarez, Carlos; Pérez, Quionia; Villanueva, Noemi; Berros, José P.; Izquierdo, Marta; Viéitez, José M.

    2013-01-01

    Treatment options for patients with high-grade pancreatic neuroendocrine tumors (pNET) are limited, especially for those with progressive disease and for those who experience treatment failure. Everolimus, an oral inhibitor of mammalian target of rapamycin (mTOR), has been approved for the treatment of patients with low- or intermediate-grade advanced pNET. In the randomized phase III RADIANT-3 study in patients with low- or intermediate-grade advanced pNET, everolimus significantly increased progression-free survival (PFS) and decreased the relative risk for disease progression by 65% over placebo. This case report describes a heavily pretreated patient with high-grade pNET and liver and peritoneal metastases who achieved prolonged PFS, clinically relevant partial radiologic tumor response, and resolution of constitutional symptoms with improvement in Karnofsky performance status while receiving a combination of everolimus and octreotide long-acting repeatable (LAR). Radiologic and clinical responses were maintained for 19 months, with minimal toxicity over the course of treatment. This case supports the findings that the combination of everolimus plus octreotide LAR may be considered for use in patients with high-grade pNET and progressive disease. Although behavior and aggressiveness are different between low- or intermediate-grade and high-grade pNET, some high-grade pNET may express mTOR; hence, everolimus should be considered in a clinical trial. PMID:24019785

  11. Who benefits most from THC:CBD spray? Learning from clinical experience.

    PubMed

    Koehler, Jürgen

    2014-01-01

    Patients with multiple sclerosis (MS) represent a diverse and heterogeneous population varying in terms of disease type, its severity and variable progression/time-course, and with regard to the wide range of presenting symptoms. Consequently, detailed experience with individual patients is important to provide examples of therapy to specific patient types. In this article, real-life data from clinical practice showing specific aspects relating to use of 9-delta-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex®) in patients with moderate to severe spasticity resistant to usual therapy will be presented. Three common clinical scenarios will be considered: MS patients with resistance to usual spasticity therapies; patients with impairment in MS spasticity symptoms; MS patients with relevant impairment in quality of life/activities of daily living (QoL/ADL). These case reports highlight the diverse nature of the MS spasticity population and they show the possible usefulness of THC:CBD oromucosal spray in individual patients with moderate to severe spasticity resistant to existing therapies, within the frame of use approved after large clinical trial results. Perhaps the most important finding is the possibility of obtaining relevant improvements in QoL/ADL in some patients with resistant MS spasticity, allowing them to engage back in physical and social activities. PMID:24457847

  12. The benefits of an additional worker are task-dependent: assessing low-back injury risks during prefabricated (panelized) wall construction.

    PubMed

    Kim, Sunwook; Nussbaum, Maury A; Jia, Bochen

    2012-09-01

    Team manual material handling is a common practice in residential construction where prefabricated building components (e.g., wall panels) are increasingly used. As part of a larger effort to enable proactive control of ergonomic exposures among workers handling panels, this study explored the effects of additional workers on injury risks during team-based panel erection tasks, specifically by quantifying how injury risks are affected by increasing the number of workers (by one, above the nominal or most common number). Twenty-four participants completed panel erection tasks with and without an additional worker under different panel mass and size conditions. Four risk assessment methods were employed that emphasized the low back. Though including an additional worker generally reduced injury risk across several panel masses and sizes, the magnitude of these benefits varied depending on the specific task and exhibited somewhat high variability within a given task. These results suggest that a simple, generalizable recommendation regarding team-based panel erection tasks is not warranted. Rather, a more systems-level approach accounting for both injury risk and productivity (a strength of panelized wall systems) should be undertaken.

  13. Early Benefit Assessments in Oncology in Germany: How Can a Clinically Relevant Endpoint Not Be Relevant to Patients?

    PubMed

    Ruof, Jörg; Flückiger, Olivier; Andre, Niko

    2015-09-01

    After 4 years of early benefit assessment (EBA) in Germany, it is becoming evident that the Federal Joint Committee (FJC) frequently considers well-established clinical endpoints as not being relevant to patients. Focusing on assessments of oncology medicines, we analysed the FJC's view on primary endpoints and compared it with the approach used by regulatory authorities. Mortality data were accepted by both stakeholders. Whereas regulatory authorities accepted primary morbidity endpoints such as progression-free survival and response rates, the FJC mostly excluded these from its assessments. Health-related quality of life (HRQoL) data have been poorly reflected in the approval process; for EBAs, those data have rarely impacted on benefit ratings. We argue that agreement between regulatory authorities and the FJC is required regarding primary study endpoints that are relevant to patients, and that clarification of acceptable endpoints by the FJC, especially in the morbidity domain, has to be provided. Moreover, in order to fully acknowledge the benefit of a new medicinal product, mortality, morbidity and HRQoL should be weighted differentially, according to the condition. PMID:26286202

  14. A four gene signature predicts benefit from anthracyclines: evidence from the BR9601 and MA.5 clinical trials.

    PubMed

    Spears, Melanie; Yousif, Fouad; Lyttle, Nicola; Boutros, Paul C; Munro, Alison F; Twelves, Chris; Pritchard, Kathleen I; Levine, Mark N; Shepherd, Lois; Bartlett, John M S

    2015-10-13

    Chromosome instability (CIN) in solid tumours results in multiple numerical and structural chromosomal aberrations and is associated with poor prognosis in multiple tumour types. Recent evidence demonstrated CEP17 duplication, a CIN marker, is a predictive marker of anthracycline benefit. An analysis of the BR9601 and MA.5 clinical trials was performed to test the role of existing CIN gene expression signatures as predictive markers of anthracycline sensitivity in breast cancer. Univariate analysis demonstrated, high CIN25 expression score was associated with improved distant relapse free survival (DRFS) (HR: 0.74, 95% CI 0.54-0.99, p = 0.046). High tumour CIN70 and CIN25 scores were associated with aggressive clinicopathological phenotype and increased sensitivity to anthracycline therapy compared to low CIN scores. However, in a prospectively planned multivariate analysis only pathological grade, nodal status and tumour size were significant predictors of outcome for CIN25/CIN70. A limited gene signature was generated, patients with low tumour CIN4 scores benefited from anthracycline treatment significantly more than those with high CIN4 scores (HR 0.37, 95% CI 0.20-0.56, p = 0.001). In multivariate analyses the treatment by marker interaction for CIN4/anthracyclines demonstrated hazard ratio of 0.35 (95% CI 0.15-0.80, p = 0.012) for DRFS. This data shows CIN4 is independent predictor of anthracycline benefit for DRFS in breast cancer.

  15. Addition of Autologous Mesenchymal Stem Cells to Whole Blood for Bio-Enhanced ACL Repair has No Benefit in the Porcine Model

    PubMed Central

    Proffen, Benedikt L.; Vavken, Patrick; Haslauer, Carla M.; Fleming, Braden C.; Harris, Chad E.; Machan, Jason T.; Murray, Martha M.

    2015-01-01

    an extracellular matrix carrier with the blood did not improve the functional results of bio-enhanced ACL repair after 15 weeks of healing in the pig model. Clinical Relevance Whole blood represents a practical biologic additive to ligament repair, and any other additive (including stem cells) should be demonstrated to be superior to this baseline before clinical use is considered. PMID:25549633

  16. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications

    PubMed Central

    Tendal, Britta; Hróbjartsson, Asbjørn; Jørgensen, Karsten Juhl; Lundh, Andreas; Schroll, Jeppe; Gøtzsche, Peter C

    2014-01-01

    Objective To determine, using research on duloxetine for major depressive disorder as an example, if there are inconsistencies between protocols, clinical study reports, and main publicly available sources (journal articles and trial registries), and within clinical study reports themselves, with respect to benefits and major harms. Design Data on primary efficacy analysis and major harms extracted from each data source and compared. Setting Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval for major depressive disorder. Data sources Clinical study reports, including protocols as appendices (total 13 729 pages), were obtained from the EMA in May 2011. Journal articles were identified through relevant literature databases and contacting the manufacturer, Eli Lilly. Clinicaltrials.gov and the manufacturer’s online clinical trial registry were searched for trial results. Results Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor inconsistencies in the population in the primary efficacy analysis between the protocol and clinical study report and within the clinical study report for one trial. Furthermore, we found contradictory information within the reports for seven serious adverse events and eight adverse events that led to discontinuation but with no apparent bias. In each trial, a median of 406 (range 177-645) and 166 (100-241) treatment emergent adverse events (adverse events that emerged or worsened after study drug was started) in the randomised phase were not reported in journal articles and Lilly trial registry reports, respectively. We also found publication bias in relation to beneficial effects. Conclusion Clinical study reports contained extensive data on major harms that were

  17. Clinical and microbiological benefits of strict supragingival plaque control as part of the active phase of periodontal therapy

    PubMed Central

    FERES, Magda; GURSKY, Lauren Christine; FAVERI, Marcelo; TSUZUKI, Claudia Ota; FIGUEIREDO, Luciene Cristina

    2009-01-01

    Aim To compare the clinical and microbiological effects of scaling and root planing (SRP) alone or combined with mechanical (professional plaque control - PPC) or chemical (chlorhexidine rinsing - CHX) control of supragingival plaque in the treatment of chronic periodontitis. Methods Sixty subjects were randomly assigned to receive SRP alone or combined with PPC (twice a week) or with CHX rinsing (twice a day). The adjunctive treatments began with SRP and continued for 42 days. Clinical and microbiological examinations were performed at baseline, 2 and 6 months post-therapy. Subgingival plaque samples were analyzed for 38 bacterial species by checkerboard DNA-DNA hybridization. Results The two test treatments were more effective in improving probing depth and clinical attachment level (CAL) than SRP alone, even in intermediate and deep sites. CAL gain was better maintained in the CHX group. The most beneficial microbiological changes were observed in CHX-treated subjects, who showed a significant reduction in the proportions of red and orange complexes, as well as an increase in the proportions of the host-compatible bacterial species. Conclusion Strict plaque control performed during and after SRP improves periodontal treatment outcomes. The greatest microbiological and clinical benefits were observed with the use of CHX rinsing. PMID:19703236

  18. Imaging Radiation Doses and Associated Risks and Benefits in Subjects Participating in Breast Cancer Clinical Trials

    PubMed Central

    Spera, Gonzalo; Meyer, Carlos; Cabral, Pablo; Mackey, John R.

    2015-01-01

    Background. Medical imaging is commonly required in breast cancer (BC) clinical trials to assess the efficacy and/or safety of study interventions. Despite the lack of definitive epidemiological data linking imaging radiation with cancer development in adults, concerns exist about the risks of imaging radiation-induced malignancies (IRIMs) in subjects exposed to repetitive imaging. We estimated the imaging radiation dose and IRIM risk in subjects participating in BC trials. Materials and Methods. The imaging protocol requirements in 10 phase III trials in the adjuvant and advanced settings were assessed to estimate the effective radiation dose received by a typical and fully compliant subject in each trial. For each study, the excess lifetime attributable cancer risk (LAR) was calculated using the National Cancer Institute’s Radiation Risk Assessment Tool, version 3.7.1. Dose and risk calculations were performed for both imaging intensive and nonintensive approaches to reflect the variability in imaging performed within the studies. Results. The total effective imaging radiation dose was 0.4–262.2 mSv in adjuvant trials and 26–241.3 mSv in metastatic studies. The dose variability resulted from differing protocol requirements and imaging intensity approaches, with computed tomography, multigated acquisition scans, and bone scans as the major contributors. The mean LAR was 1.87–2,410/100,000 in adjuvant trials (IRIM: 0.0002%–2.41% of randomized subjects) and 6.9–67.3/100,000 in metastatic studies (IRIM: 0.007%–0.067% of subjects). Conclusion. IRIMs are infrequent events. In adjuvant trials, aligning the protocol requirements with the clinical guidelines’ surveillance recommendations and substituting radiating procedures with equivalent nonradiating ones would reduce IRIM risk. No significant risk has been observed in metastatic trials, and potential concerns on IRIMs are not justified. Implications for Practice: Medical imaging is key in breast cancer

  19. Expectations of benefit and tolerance to risk of individuals with spinal cord injury regarding potential participation in clinical trials.

    PubMed

    Kwon, Brian K; Ghag, Arvindera; Dvorak, Marcel F; Tetzlaff, Wolfram; Illes, Judy

    2012-12-10

    We conducted a survey of individuals living with spinal cord injury (SCI) to determine their receptivity to participating in clinical trials of drug therapies or stem cell therapies, their anticipation of therapeutic benefits, and their tolerance to risk. A 46-item questionnaire was administered to individuals with cervical or thoracic SCI identified through a provincial database. The average age was 42 years and the individuals were, on average, 5.5 years post-injury. Receptivity to neuroprotective drug trials in the acute setting was very high, but somewhat less so for stem cell trials in the subacute or chronic (current) setting. With respect to expectation of functional benefit, approximately one third of the respondents indicated that they would want a 5-25% chance of achieving some functional recovery if enrolling in a stem cell therapy clinical trial in the current, chronic injury state. Whereas the majority typically would require the risk of spinal cord damage, cancer, infection, and nerve pain from invasive cell transplantation trials to be ≤1%, 15-30% would participate regardless of the risk of these complications. The factors associated with this high risk tolerance were gender (males>females), age (elderly>young), and self-reported knowledge of SCI research (greater knowledge>less knowledge). Injury severity or chronicity did not have a significant correlation with risk tolerance. Whereas previous studies have shown that the understanding of stem cell science is limited among individuals with SCI, here we show that many still have high hopes for the possibility of neurological benefit, are anxious to participate in invasive stem cell trials, and, in many cases, have high tolerance for risk in such trials. Taken together, the data underscore the need for careful communication with individuals with SCI to avoid unrealistic expectations and therapeutic misconception in experimental trials.

  20. [Clinical benefit of HCV core antigen assay in patients receiving interferon and ribavirin combination therapy].

    PubMed

    Higashimoto, Makiko; Takahashi, Masahiko; Jokyu, Ritsuko; Saito, Hidetsugu

    2006-02-01

    A highly sensitive second generation HCV core antigen assay has recently been developed. We compared viral disappearance and kinetics data between commercially available core antigen assays, Lumipulse Ortho HCV Ag, and a quantitative HCV RNA PCR assay, Cobas Amplicor HCV Monitor Test, Version 2 to estimate the predictive benefit of sustained viral response (SVR) and non-SVR in 59 patients treated with interferon and ribavirin combination therapy. We found a good correlation between HCV core Ag and HCV RNA level regardless of genotype. Although the sensitivity of the core antigen assay was lower than PCR, the dynamic range was broader than that of the PCR assay, so that we did not need to dilute the samples in 59 patients. We detected serial decline of core Ag levels in 24 hrs, 7 days and 14 days after interferon combination therapy. The decline of core antigen levels was significant in SVR patients compared to non-SVR as well as in genotype 2a, 2b patients compared to 1b. Core antigen-negative on day 1 could predict all 10 SVR patients (PPV = 100%), whereas RNA-negative could predict 22 SVR out of 25 on day 14 (PPV = 88.0%). None of the patients who had detectable serum core antigen on day 14 became SVR(NPV = 100%), although NPV was 91.2% on RNA negativity. An easy, simple, low cost new HCV core antigen detecting system seems to be useful for assessing and monitoring IFN treatment for HCV.

  1. Clinically Normal Stereopsis Does Not Ensure a Performance Benefit from Stereoscopic 3D Depth Cues

    NASA Astrophysics Data System (ADS)

    McIntire, John P.; Havig, Paul R.; Harrington, Lawrence K.; Wright, Steve T.; Watamaniuk, Scott N. J.; Heft, Eric L.

    2014-09-01

    To investigate the effect of manipulating disparity on task performance and viewing comfort, twelve participants were tested on a virtual object precision placement task while viewing a stereoscopic 3D (S3D) display. All participants had normal or corrected-to-normal visual acuity, passed the Titmus stereovision clinical test, and demonstrated normal binocular function, including phorias and binocular fusion ranges. Each participant completed six experimental sessions with different maximum binocular disparity limits. The results for ten of the twelve participants were generally as expected, demonstrating a large performance advantage when S3D cues were provided. The sessions with the larger disparity limits typically resulted in the best performance, and the sessions with no S3D cues the poorest performance. However, one participant demonstrated poorer performance in sessions with smaller disparity limits but improved performance in sessions with the larger disparity limits. Another participant's performance declined whenever any S3D cues were provided. Follow-up testing suggested that the phenomenon of pseudo-stereoanomaly may account for one viewer's atypical performance, while the phenomenon of stereoanomaly might account for the other. Overall, the results demonstrate that a subset of viewers with clinically normal binocular and stereoscopic vision may have difficulty performing depth-related tasks on S3D displays. The possibility of the vergence-accommodation conflict contributing to individual performance differences is also discussed.

  2. [Institute for clinical management of nephro-urological diseases: the benefits of a quality care programme].

    PubMed

    Santiñá, M; Arrizabalaga, P; Prat, A; Alcaraz, A; Campistol, J M; Trilla, A

    2009-01-01

    The Clinic Institute of Nefro and Urology (ICNU) was formed in Clinic Hospital of Barcelona in 1999. It grouped together services of Nephrology, Urology and Renal Transplant. At the same time, in order to ensure Quality in this process of change, we designed a specific quality program. In this program, we defined objectives to improve the quality of these services in one year and we defined different quality indicators in order to maintain and monitor health quality. The indicators referred to technical quality and perceived quality and we periodically evaluated their evolution. The results of the last five years indicate that the majority of the indicators have improved, except those concerning infections surgery and the response to complaints. This has helped the consolidation and recognition of the work of this innovatory project in the health management of the nephrologic and urinary systems that locate the patient in the center of the organization and recognize the health professionals as the true managers of this model.

  3. The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics.

    PubMed

    Trusheim, Mark R; Berndt, Ernst R

    2015-12-01

    The stratified medicine companion diagnostic (CDx) cut-off decision integrates scientific, clinical, ethical, and commercial considerations, and determines its value to developers, providers, payers, and patients. Competition already sharpens these issues in oncology, and might soon do the same for emerging stratified medicines in autoimmune, cardiovascular, neurodegenerative, respiratory, and other conditions. Of 53 oncology targets with a launched therapeutic, 44 have competing therapeutics. Only 12 of 141 Phase III candidates addressing new targets face no competition. CDx choices might alter competitive positions and reimbursement. Under current diagnostic incentives, payers see novel stratified medicines that improve public health and increase costs, but do not observe companion diagnostics for legacy treatments that would reduce costs. It would be in the interests of payers to rediscover their heritage of direct investment in diagnostic development. PMID:26542060

  4. Clinical benefits of alpharadin in castrate-chemotherapy-resistant prostate cancer: case report and literature review

    PubMed Central

    Croke, Jennifer; Leung, Eugene; Segal, Roanne; Malone, Shawn

    2012-01-01

    Prostate cancer has the second-highest mortality worldwide in men. The most common site of metastasis is bone. Bone metastases and their resulting complications represent a significant source of morbidity. Radioisotopes have been used for treatment of painful bony metastases. Although shown to decrease pain and analgesia use, this has not improved outcomes. The following case report describes a patient with castrate-resistant prostate cancer who was treated with the radioisotope radium-223 as part of the phase III clinical trial Alpharadin in Patients with Symptomatic Hormone Refractory Prostate Cancer with Skeletal Metastases (ALSYMPCA). He responded to radium-223 with pain relief, bone scan response, stabilisation of prostate specific antigen (PSA) and normalisation of alkaline phosphatase. Interim analysis of this trial has shown that radium-223 significantly prolongs overall survival, time to first skeletal-related event and is well tolerated. Alpharadin is a new treatment option for men with castrate-resistant prostate cancer and symptomatic bone metastases. PMID:23125297

  5. Inspiratory and expiratory respiratory muscle training as an adjunct to concurrent strength and endurance training provides no additional 2000 m performance benefits to rowers.

    PubMed

    Bell, Gordon J; Game, Alex; Jones, Richard; Webster, Travis; Forbes, Scott C; Syrotuik, Dan

    2013-01-01

    The purpose of this study was to examine respiratory muscle training (RMT) combined with 9 weeks of resistance and endurance training on rowing performance and cardiopulmonary responses. Twenty-seven rowers (mean ± SD: age = 27 ± 9 years; height = 176.9 ± 10.8 cm; and body mass = 76.1 ± 12.6 kg) were randomly assigned to an inspiratory only (n = 13) or expiratory only (n = 14) training group. Both RMT programs were 3 sets of 10 reps, 6 d/wk in addition to an identical 3 d/wk resistance and 3 d/wk endurance training program. Both groups showed similar improvements in 2000 m rowing performance, cardiorespiratory fitness, strength, and maximum inspiratory (PImax) and expiratory (PEmax) pressures (p < .05). It was concluded that there were no additional benefits of 9 weeks of inspiratory or expiratory RMT on simulated 2000 m rowing performance or cardiopulmonary responses when combined with resistance and endurance training in rowers.

  6. Necessity and benefits of physician assistants' participation in international clinical experiences.

    PubMed

    Kibe, Lucy Wachera

    2012-01-01

    Several consultation stations have been set up in an unfinished stone building. My team is made up of a Kenyan physician assistant (called clinical officer), a Kenyan medical student, and me, a US physician assistant student. We are huddled around a small worn-out square table. A middle-aged woman and her two children, ages 2 and 6, approach the table. They have traveled 2 miles to the medical camp. The children, covered in dust, are emaciated with protruding abdomens, dry skin, and congested noses. The clinical officer (CO) conducts a brief interview in Swahili, the Kenyan national language. The mother explains that they have been coughing up thick yellow sputum for a week and have no appetite. They've also had diarrhea for a couple of weeks. I examine the children, who are obviously scared. Hot, moist skin. They are both running a fever. I listen to the lungs: reduced lung sounds. The protruding abdomens are rock hard. I report the findings to the team. The CO turns to the Kenyan medical student and me and quizzes us on differential diagnoses with rationale for each. We come up with malaria, pneumonia, TB, and worm infestation. Due to limited resources, medical diagnosis in Kenya relies heavily on history and physical exam. The CO explains that comorbid conditions are probable. Luckily, we have malaria-testing kits at the camp. They test negative for malaria. We decide to treat them for pneumonia. We also offer them a free hot meal, toothbrushes, T-shirts, coloring paper, and crayons. The children manage to smile. The mother is so grateful, she cries. PMID:23437625

  7. Clinical and economic benefits of fidaxomicin compared to vancomycin for Clostridium difficile infection.

    PubMed

    Gallagher, Jason C; Reilly, Joseph P; Navalkele, Bhagyashri; Downham, Gemma; Haynes, Kevin; Trivedi, Manish

    2015-11-01

    We studied the clinical and economic impact of a protocol encouraging the use of fidaxomicin as a first-line drug for treatment of Clostridium difficile infection (CDI) in patients hospitalized during a 2-year period. This study evaluated patients who received oral vancomycin or fidaxomicin for the treatment of CDI during a 2-year period. All included patients were eligible for administration of fidaxomicin via a protocol that encouraged its use for selected patients. The primary clinical endpoint was 90-day readmission with a diagnosis of CDI. Hospital charges and insurance reimbursements for readmissions were calculated along with the cost of CDI therapy to estimate the financial impact of the choice of therapy. Recurrences were seen in 10/49 (20.4%) fidaxomicin patients and 19/46 (41.3%) vancomycin patients (P = 0.027). In a multivariate analysis that included determinations of severity of CDI, serum creatinine increases, and concomitant antibiotic use, only fidaxomicin was significantly associated with decreased recurrence (adjusted odds ratio [aOR], 0.33; 95% confidence interval [CI], 0.12 to 0.93). The total lengths of stay of readmitted patients were 183 days for vancomycin and 87 days for fidaxomicin, with costs of $454,800 and $196,200, respectively. Readmissions for CDI were reimbursed on the basis of the severity of CDI, totaling $151,136 for vancomycin and $107,176 for fidaxomicin. Fidaxomicin drug costs totaled $62,112, and vancomycin drug costs were $6,646. We calculated that the hospital lost an average of $3,286 per fidaxomicin-treated patient and $6,333 per vancomycin-treated patient, thus saving $3,047 per patient with fidaxomicin. Fidaxomicin use for CDI treatment prevented readmission and decreased hospital costs compared to use of oral vancomycin.

  8. HIV-specific humoral responses benefit from stronger prime in phase Ib clinical trial

    PubMed Central

    Bart, Pierre-Alexandre; Huang, Yunda; Karuna, Shelly T.; Chappuis, Samuel; Gaillard, Julien; Kochar, Nidhi; Shen, Xiaoying; Allen, Mary A.; Ding, Song; Hural, John; Liao, Hua-Xin; Haynes, Barton F.; Graham, Barney S.; Gilbert, Peter B.; McElrath, M. Juliana; Montefiori, David C.; Tomaras, Georgia D.; Pantaleo, Giuseppe; Frahm, Nicole

    2014-01-01

    BACKGROUND. Vector prime-boost immunization strategies induce strong cellular and humoral immune responses. We examined the priming dose and administration order of heterologous vectors in HIV Vaccine Trials Network 078 (HVTN 078), a randomized, double-blind phase Ib clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost regimens, with a New York vaccinia HIV clade B (NYVAC-B) vaccine and a recombinant adenovirus 5–vectored (rAd5-vectored) vaccine. METHODS. NYVAC-B included HIV-1 clade B Gag-Pol-Nef and gp120, while rAd5 included HIV-1 clade B Gag-Pol and clades A, B, and C gp140. Eighty Ad5-seronegative subjects were randomized to receive 2 × NYVAC-B followed by 1 × 1010 PFU rAd5 (NYVAC/Ad5hi); 1 × 108 PFU rAd5 followed by 2 × NYVAC-B (Ad5lo/NYVAC); 1 × 109 PFU rAd5 followed by 2 × NYVAC-B (Ad5med/NYVAC); 1 × 1010 PFU rAd5 followed by 2 × NYVAC-B (Ad5hi/NYVAC); or placebo. Immune responses were assessed 2 weeks after the final vaccination. Intracellular cytokine staining measured T cells producing IFN-γ and/or IL-2; cross-clade and epitope-specific binding antibodies were determined; and neutralizing antibodies (nAbs) were assessed with 6 tier 1 viruses. RESULTS. CD4+ T cell response rates ranged from 42.9% to 93.3%. NYVAC/Ad5hi response rates (P ≤ 0.01) and magnitudes (P ≤ 0.03) were significantly lower than those of other groups. CD8+ T cell response rates ranged from 65.5% to 85.7%. NYVAC/Ad5hi magnitudes were significantly lower than those of other groups (P ≤ 0.04). IgG response rates to the group M consensus gp140 were 89.7% for NYVAC/Ad5hi and 21.4%, 84.6%, and 100% for Ad5lo/NYVAC, Ad5med/NYVAC, and Ad5hi/NYVAC, respectively, and were similar for other vaccine proteins. Overall nAb responses were low, but aggregate responses appeared stronger for Ad5med/NYVAC and Ad5hi/NYVAC than for NYVAC/Ad5hi. CONCLUSIONS. rAd5 prime followed by NYVAC boost is superior to the reverse regimen for both vaccine

  9. Additional technician tasks and turnaround time in the clinical Stat laboratory

    PubMed Central

    Salinas, Maria; López-Garrigós, Maite; Flores, Emilio; Leiva-Salinas, Maria; Lillo, Rosa; Leiva-Salinas, Carlos

    2016-01-01

    Introduction Many additional tasks in the Stat laboratory (SL) increase the workload. It is necessary to control them because they can affect the service provided by the laboratory. Our aim is to calculate these tasks, study their evolution over a 10 year period, and compare turnaround times (TAT) in summer period to the rest of the year. Materials and methods Additional tasks were classified as “additional test request” and “additional sample”. We collected those incidences from the laboratory information system (LIS), and calculated their evolution over time. We also calculated the monthly TAT for troponin for Emergency department (ED) patients, as the difference between the verification and LIS registration time. A median time of 30 minutes was our indicator target. TAT results and tests workload in summer were compared to the rest of the year. Results Over a 10-year period, the technologists in the SL performed 51,385 additional tasks, a median of 475 per month. The workload was significantly higher during the summer (45,496 tests) than the rest of the year (44,555 tests) (P = 0.019). The troponin TAT did not show this variation between summer and the rest of the year, complying always with our 30 minutes indicator target. Conclusion The technicians accomplished a significant number of additional tasks, and the workload kept increasing over the period of 10 years. That did not affect the TAT results. PMID:27346970

  10. Benefits attained from space flight in pre-clinical evaluation of candidate drugs

    NASA Astrophysics Data System (ADS)

    Stodieck, Louis S.; Bateman, Ted; Ayers, Reed; Ferguson, Virginia; Simske, Steve

    1998-01-01

    Modern medicine has made great strides in recent decades. The promises of biotechnology and advances in gene identification and manipulation offer tremendous potential for treatment of disease. However, developing new drug therapies by biotechnology and pharmaceutical companies is still a very costly and time consuming process. One of the important milestones in drug development is the successful completion of preclinical evaluation. During this phase, drug candidates must be shown to be safe, yet effective as a treatment of the target disease or disorder. Critical for preclinical testing is the availability of biomedical test models that adequately mimic the target disease. A good model will 1) allow confident prediction of a drug's effects before expensive clinical trials are begun, 2) provide convincing data for use in an FDA new drug application and 3) minimize the time required for testing. Space flight may offer a completely unique and new set of biomedical models for use in pharmaceutical testing. This paper highlights some examples of recent experiments done in space to test new compounds for Chiron, (Emmeryville, CA) and discusses the importance of the International Space Station to greatly expand such commercial opportunities.

  11. Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications

    PubMed Central

    Roelants, Fabienne; Pospiech, Audrey; Momeni, Mona; Watremez, Christine

    2016-01-01

    The aim of this review is to summarize data published on the use of perioperative hypnosis in patients undergoing breast cancer surgery (BCS). Indeed, the majority of BCS patients experience stress, anxiety, nausea, vomiting, and pain. Correct management of the perioperative period and surgical removal of the primary tumor are clearly essential but can affect patients on different levels and hence have a negative impact on oncological outcomes. This review examines the effect of clinical hypnosis performed during the perioperative period. Thanks to its specific properties and techniques allowing it to be used as complementary treatment preoperatively, hypnosis has an impact most notably on distress and postoperative pain. During surgery, hypnosis may be applied to limit immunosuppression, while, in the postoperative period, it can reduce pain, anxiety, and fatigue and improve wound healing. Moreover, hypnosis is inexpensive, an important consideration given current financial concerns in healthcare. Of course, large randomized prospective studies are now needed to confirm the observed advantages of hypnosis in the field of oncology.

  12. Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications

    PubMed Central

    Roelants, Fabienne; Pospiech, Audrey; Momeni, Mona; Watremez, Christine

    2016-01-01

    The aim of this review is to summarize data published on the use of perioperative hypnosis in patients undergoing breast cancer surgery (BCS). Indeed, the majority of BCS patients experience stress, anxiety, nausea, vomiting, and pain. Correct management of the perioperative period and surgical removal of the primary tumor are clearly essential but can affect patients on different levels and hence have a negative impact on oncological outcomes. This review examines the effect of clinical hypnosis performed during the perioperative period. Thanks to its specific properties and techniques allowing it to be used as complementary treatment preoperatively, hypnosis has an impact most notably on distress and postoperative pain. During surgery, hypnosis may be applied to limit immunosuppression, while, in the postoperative period, it can reduce pain, anxiety, and fatigue and improve wound healing. Moreover, hypnosis is inexpensive, an important consideration given current financial concerns in healthcare. Of course, large randomized prospective studies are now needed to confirm the observed advantages of hypnosis in the field of oncology. PMID:27635132

  13. Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications.

    PubMed

    Potié, Arnaud; Roelants, Fabienne; Pospiech, Audrey; Momeni, Mona; Watremez, Christine

    2016-01-01

    The aim of this review is to summarize data published on the use of perioperative hypnosis in patients undergoing breast cancer surgery (BCS). Indeed, the majority of BCS patients experience stress, anxiety, nausea, vomiting, and pain. Correct management of the perioperative period and surgical removal of the primary tumor are clearly essential but can affect patients on different levels and hence have a negative impact on oncological outcomes. This review examines the effect of clinical hypnosis performed during the perioperative period. Thanks to its specific properties and techniques allowing it to be used as complementary treatment preoperatively, hypnosis has an impact most notably on distress and postoperative pain. During surgery, hypnosis may be applied to limit immunosuppression, while, in the postoperative period, it can reduce pain, anxiety, and fatigue and improve wound healing. Moreover, hypnosis is inexpensive, an important consideration given current financial concerns in healthcare. Of course, large randomized prospective studies are now needed to confirm the observed advantages of hypnosis in the field of oncology. PMID:27635132

  14. Clinical image benefits after model-based reconstruction for low dose dedicated breast tomosynthesis

    NASA Astrophysics Data System (ADS)

    Haneda, Eri; Tkaczyk, J. Eric; Palma, Giovanni; Iordache, Rǎzvan; Muller, Serge; De Man, Bruno

    2015-03-01

    Model-based iterative reconstruction (MBIR) is implemented to process full clinical data sets of dedicated breast tomosynthesis (DBT) in a low dose condition and achieves less spreading of anatomical structure between slices. MBIR is a statistical based reconstruction which can control the trade-off between data fitting and image regularization. In this study, regularization is formulated with anisotropic prior weighting that independently controls the image regularization between in-plane and out-of-plane voxel neighbors. Studies at complete and partial convergence show that the appropriate formulation of data-fit and regularization terms along with anisotropic prior weighting leads to a solution with improved localization of objects within a more narrow range of slices. This result is compared with the solutions using simultaneous iterative reconstruction technique (SIRT), which is one of the state of art reconstruction in DBT. MBIR yields higher contrast-to-noise for medium and large size microcalcifications and diagnostic structures in volumetric breast images and supports opportunity for dose reduction for 3D breast imaging.

  15. From cannabis to the endocannabinoid system: refocussing attention on potential clinical benefits.

    PubMed

    Youssef, F F; Irving, A J

    2012-06-01

    Cannabis sativa is one of the oldest herbal remedies known to man. Over the past four thousand years, it has been used for the treatment of numerous diseases but due to its psychoactive properties, its current medicinal usage is highly restricted. In this review, we seek to highlight advances made over the last forty years in the understanding of the mechanisms responsible for the effects of cannabis on the human body and how these can potentially be utilized in clinical practice. During this time, the primary active ingredients in cannabis have been isolated, specific cannabinoid receptors have been discovered and at least five endogenous cannabinoid neurotransmitters (endocannabinoids) have been identified. Together, these form the framework of a complex endocannabinoid signalling system that has widespread distribution in the body and plays a role in regulating numerous physiological processes within the body. Cannabinoid ligands are therefore thought to display considerable therapeutic potential and the drive to develop compounds that can be targeted to specific neuronal systems at low enough doses so as to eliminate cognitive side effects remains the 'holy grail' of endocannabinoid research.

  16. Effectiveness of an on-site health clinic at a self-insured university: a cost-benefit analysis.

    PubMed

    McCaskill, Sherrie P; Schwartz, Lisa A; Derouin, Anne L; Pegram, Angela H

    2014-04-01

    This study assessed the impact and cost-effectiveness of an on-site health clinic at a self-insured university. Health care costs and number of claims filed to primary care providers were trended before and after the clinic was established to determine savings. A retrospective chart review of all full-time, insured employees treated for upper respiratory tract infections (URIs) during a 1-year study period was conducted. On-site clinic costs for the treatment of URIs were compared to costs at outside community providers for similar care. Community cost norms for the treatment of URIs were provided by Primary Physicians Care, the administrator of insurance claims for the University. A cost-benefit analysis compared the cost of services on-site versus similar services at an outside community provider. Based on the results of this study, the University's on-site health care services were determined to be more cost-effective than similar off-site health care services for the treatment of URIs. [Workplace Health Saf 2014;62(4):162-169.].

  17. Baseline risk as predictor of treatment benefit: three clinical meta-re-analyses.

    PubMed

    Arends, L R; Hoes, A W; Lubsen, J; Grobbee, D E; Stijnen, T

    2000-12-30

    A relationship between baseline risk and treatment effect is increasingly investigated as a possible explanation of between-study heterogeneity in clinical trial meta-analysis. An approach that is still often applied in the medical literature is to plot the estimated treatment effects against the estimated measures of risk in the control groups (as a measure of baseline risk), and to compute the ordinary weighted least squares regression line. However, it has been pointed out by several authors that this approach can be seriously flawed. The main problem is that the observed treatment effect and baseline risk measures should be viewed as estimates rather than the true values. In recent years several methods have been proposed in the statistical literature to potentially deal with the measurement errors in the estimates. In this article we propose a vague priors Bayesian solution to the problem which can be carried out using the 'Bayesian inference using Gibbs sampling' (BUGS) implementation of Markov chain Monte Carlo numerical integration techniques. Different from other proposed methods, it uses the exact rather than an approximate likelihood, while it can handle many different treatment effect measures and baseline risk measures. The method differs from a recently proposed Bayesian method in that it explicitly models the distribution of the underlying baseline risks. We apply the method to three meta-analyses published in the medical literature and compare the results with the outcomes of the other recently proposed methods. In particular we compare our approach to McIntosh's method, for which we show how it can be carried out using standard statistical software. We conclude that our proposed method offers a very general and flexible solution to the problem, which can be carried out relatively easily with existing Bayesian analysis software. A confidence band for the underlying relationship between true effect measure and baseline risk and a confidence interval

  18. Peritoneal dialysis solutions low in glucose degradation products--evidence for clinical benefits.

    PubMed

    Tomo, Tadashi

    2008-06-01

    In Japan, two types of new peritoneal dialysis fluid (PDF) are ordinarily used: two-chambered PDF, and icodextrin PDF. Two-chambered PDF has several biocompatible characteristics, one being low glucose degradation products (GDPs). Of the several GDPs in PDF, 3,4-dideoxyglucosone-3-ene (3,4-DGE) is thought to be strongly associated with the cytotoxicity of standard PDF. Using a PDF low in GDPs may reduce exposure of the peritoneum to 3,4-DGE, helping to preserve peritoneal function in PD patients. Additionally, use of a PDF low in GDPs may reduce plasma levels of advanced glycosylation end-products in PD patients, a change that may help to preserve vascular function in PD patients. Peritoneal rest for 24 hours after exposure to a PDF with low GDPs improves the activity of human peritoneal mesothelial cells. As compared with the use of standard PDF, the use of low-GDP PDF in combination therapy (peritoneal dialysis plus hemodialysis) may more effectively preserve peritoneal function. The new PDF low in GDPs has biocompatible characteristics relative to peritoneum and system that may help to preserve peritoneal function or reduce complications such as atherosclerosis or dialysis-related amyloidosis in dialysis patients.

  19. Clinical and benefit--cost outcomes of teaching a mindfulness-based procedure to adult offenders with intellectual disabilities.

    PubMed

    Singh, Nirbhay N; Lancioni, Giulio E; Winton, Alan S W; Singh, Ashvind N; Adkins, Angela D; Singh, Judy

    2008-09-01

    The effects of a mindfulness-based procedure, called Meditation on the Soles of the Feet, were evaluated as a cognitive-behavioral intervention for physical aggression in 6 offenders with mild intellectual disabilities. They were taught a simple meditation technique that required them to shift their attention and awareness from the precursors of aggression to the soles of their feet, a neutral point on their body. Results showed that physical and verbal aggression decreased substantially, no Stat medication or physical restraint was required, and there were no staff or peer injuries. Benefit-cost analysis of lost days of work and cost of medical and rehabilitation because of injury caused by these individuals in both the 12 months prior to and following mindfulness-based training showed a 95.7% reduction in costs. This study suggests that this procedure may be a clinically effective and cost-effective method of enabling adult offenders with intellectual disabilities to control their aggression.

  20. Use of Anthropometry for the Prediction of Regional Body Tissue Distribution in Adults: Benefits and Limitations in Clinical Practice

    PubMed Central

    Scafoglieri, Aldo; Clarys, Jan Pieter; Cattrysse, Erik; Bautmans, Ivan

    2014-01-01

    Regional body composition changes with aging. Some of the changes in composition are considered major risk factors for developing obesity related chronic diseases which in turn may lead to increased mortality in adults. The role of anthropometry is well recognized in the screening, diagnosis and follow-up of adults for risk classification, regardless of age. Regional body composition is influenced by a number of intrinsic and extrinsic factors. Therapeutic measures recommended to lower cardiovascular disease risk include lifestyle changes. The aim of this review is to systematically summarize studies that assessed the relationships between anthropometry and regional body composition. The potential benefits and limitations of anthropometry for use in clinical practice are presented and suggestions for future research given. PMID:25489489

  1. The aspartame story: a model for the clinical testing of a food additive.

    PubMed

    Stegink, L D

    1987-07-01

    Toxicology is based on the premise that all compounds are toxic at some dose. Thus, it is not surprising that very large doses of aspartame (or its components--aspartate, phenylalanine, and methanol) produce deleterious effects in sensitive animal species. The critical question is whether aspartame ingestion is potentially harmful to humans at normal use and potential abuse levels. This paper reviews clinical studies testing the effects of various doses of aspartame upon blood levels of aspartate, phenylalanine, and methanol. These studies demonstrate that blood levels of these compounds are well below levels associated with adverse effects in sensitive animal species.

  2. Experience With Afatinib in Patients With Non-Small Cell Lung Cancer Progressing After Clinical Benefit From Gefitinib and Erlotinib

    PubMed Central

    Fischer, Jürgen R.; Grohé, Christian; Gütz, Sylvia; Thomas, Michael; Kimmich, Martin; Schneider, Claus-Peter; Laack, Eckart; Märten, Angela

    2014-01-01

    Background. Afatinib, an irreversible ErbB family blocker, demonstrated superiority to chemotherapy as first-line treatment in patients with EGFR-mutated non-small cell lung cancer (NSCLC). Afatinib is also active in patients progressing on EGFR tyrosine kinase inhibitors (EGFR-TKIs). We report the results of a large cohort of NSCLC patients receiving afatinib within a compassionate-use program (CUP). Patients and Methods. Patients with advanced NSCLC progressing after one line or more of chemotherapy and one line or more of EGFR-TKI treatment with either an EGFR mutation or documented clinical benefit were enrolled. Data collection was not monitored or verified by central review. The intention of this CUP was to provide controlled preregistration access to afatinib for patients with life-threatening diseases and no other treatment option. Results. From May 2010 to October 2013, 573 patients (65% female; median age: 64 years [range: 28–89 years]) were enrolled, with strong participation of community oncologists. Comorbidities were allowed, including second malignancies in 11% of patients. EGFR mutation status was available in 391 patients (72%), and 83% tested mutation positive. Median time to treatment failure (TTF) of 541 patients treated with afatinib was 3.7 months (range: 0.0 to >29.0 months). Median TTF was 4.0 and 2.7 months in patients with adenocarcinomas and squamous cell carcinomas, respectively, and 4.6 months in patients with EGFR-mutated NSCLC. Adverse events were generally manageable. Conclusion. Afatinib was able to be given in a real-world setting to heavily pretreated patients with EGFR-mutated or EGFR-TKI-sensitive NSCLC. Acknowledging the constraints of data collection in a CUP, afatinib appears to be safe and to confer some clinical benefit in this population. PMID:25232040

  3. β-Lactam antibiotics and vancomycin inhibit the growth of planktonic and biofilm Candida spp.: an additional benefit of antibiotic-lock therapy?

    PubMed

    Sidrim, José J C; Teixeira, Carlos E C; Cordeiro, Rossana A; Brilhante, Raimunda S N; Castelo-Branco, Débora S C M; Bandeira, Silviane P; Alencar, Lucas P; Oliveira, Jonathas S; Monteiro, André J; Moreira, José L B; Bandeira, Tereza J P G; Rocha, Marcos F G

    2015-04-01

    The aim of this study was to evaluate the effects of cefepime, meropenem, piperacillin/tazobactam (TZP) and vancomycin on strains of Candida albicans and Candida tropicalis in planktonic and biofilm forms. Twenty azole-derivative-resistant strains of C. albicans (n=10) and C. tropicalis (n=10) were tested. The susceptibility of planktonic Candida spp. to the antibacterial agents was investigated by broth microdilution. The XTT reduction assay was performed to evaluate the viability of growing and mature biofilms following exposure to these drugs. Minimum inhibitory concentrations (MICs) ranged from 0.5 mg/mL to 2 mg/mL for cefepime, TZP and vancomycin and from 0.5 mg/mL to 1 mg/mL for meropenem and the drugs also caused statistically significant reductions in biofilm cellular activity both in growing and mature biofilm. Since all of the tested drugs are commonly used in patients with hospital-acquired infections and in those with catheter-related infections under antibiotic-lock therapy, it may be possible to obtain an additional benefit from antibiotic-lock therapy with these drugs, namely the control of Candida biofilm formation.

  4. Assessing clinical outcomes of patients with acute calculous cholecystitis in addition to the Tokyo grading: a retrospective study.

    PubMed

    Cheng, Wei-Chun; Chiu, Yen-Cheng; Chuang, Chiao-Hsiung; Chen, Chiung-Yu

    2014-09-01

    The management of acute cholecystitis is still based on clinical expertise. This study aims to investigate whether the outcome of acute cholecystitis can be related to the severity criteria of the Tokyo guidelines and additional clinical comorbidities. A total of 103 patients with acute cholecystitis were retrospectively enrolled and their medical records were reviewed. They were all classified according to therapeutic modality, including early cholecystectomy and antibiotic treatment with or without percutaneous cholecystostomy. The impact of the Tokyo guidelines and the presence of comorbidities on clinical outcome were assessed by univariate and multivariate regression analyses. According to Tokyo severity grading, 48 patients were Grade I, 31 patients were Grade II, and 24 patients were Grade III. The Grade III patients had a longer hospital stay than Grade II and Grade I patients (15.2 days, 9.2 days, and 7.3 days, respectively, p < 0.05). According to multivariate analysis, patients with Grade III Tokyo severity, higher Charlson's Comorbidity Score, and encountering complications had a longer hospital stay. Based on treatment modality, surgeons selected the patients with less severity and fewer comorbidities for cholecystectomy, and these patients had a shorter hospital stay. In addition to the grading of the Tokyo guidelines, comorbidities had an additional impact on clinical outcomes and should be an important consideration when making therapeutic decisions.

  5. The clinical benefits of long-term supplementation with omega-3 fatty acids in cystic fibrosis patients - A pilot study.

    PubMed

    Hanssens, L; Thiébaut, I; Lefèvre, N; Malfroot, A; Knoop, C; Duchateau, J; Casimir, G

    2016-05-01

    Effectiveness of omega-3 supplementation in cystic fibrosis (CF) remains controversial. This study sought to evaluate clinical status, exercise tolerance, inflammatory parameters, and erythrocyte fatty acid profile after 1 year of oral omega-3 supplementation in CF patients. Fifteen ΔF508-homozygous patients undergoing chronic azithromycin were randomized to receive omega-3 fish oil supplementation at a dose of 60mg/Kg/day or placebo. In comparison with the previous year, in the supplemented group, the number of pulmonary exacerbations decreased at 12 months (1.7 vs. 3.0, p<0.01), as did the duration of antibiotic therapy (26.5 days vs. 60.0 days, p<0.025). Supplementation significantly increased the levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as early as <3 months of administration, with concomitant decreases in arachidonic acid (AA) levels. This pilot study suggests that long-term omega-3 supplementation offers several clinical benefits as to the number of exacerbations and duration of antibiotic therapy in CF patients.

  6. Clinical and histopathological evaluation of the effect of addition of immunotherapy with Mw vaccine to standard chemotherapy in borderline leprosy.

    PubMed

    Kamal, R; Natrajan, M; Katoch, K; Arora, M

    2012-01-01

    This study reports detailed analysis of clinical parameters and clearance of granuloma in borderline leprosy patients treated with immunotherapy and chemotherapy. It aims to assess the additive effect of immunotherapy (Mwvaccine) with standard MDT on clinical status of untreated borderline leprosy cases and on granuloma fraction of untreated borderline leprosy cases. Patients attending the OPD were serially recruited in two groups. A total of 150 cases in one treatment (trial) group (Mw vaccine plus MDT) and 120 cases in another treatment (control) group (MDT only) of border line leprosy have been included. After the formal written consent, detailed clinical examination, charting, smear examination of all untreated borderline patients of both groups was done, biopsies were taken from the active lesions of all patients of both groups at start of therapy and every six month thereafter till the completion of therapy. The same procedure was repeated every six months during the follow-up period. Standard MDT was given to all the patients of both groups according to type of disease. Mw vaccine 0.1 ml (0.5 x 10(9) bacilli) was injected intra-dermally at the start of therapy and every six months in addition to chemotherapy to the treatment group. The BT cases were followed up after 6 doses of MDT and 2 doses of Mw vaccine, and, the BB, BL cases were followed up after 24 doses of MDT plus 5 doses of Mw vaccine. Clinically, greater and faster improvement was observed in all the clinical parameters, faster attainment of smear negativity and two episodes of lepra reaction occurred in cases treated with combined chemotherapy and immunotherapy, as compared to controls (chemotherapy alone) wherein clinical improvement was slower in all parameters, slower attainment of smear negativity in bacillary index and seven showed the occurrence of reactions, histipathologically in addition to more rapid clearance of granuloma in immunotherapy treated group, a significant finding was an

  7. A digital process for additive manufacturing of occlusal splints: a clinical pilot study

    PubMed Central

    Salmi, Mika; Paloheimo, Kaija-Stiina; Tuomi, Jukka; Ingman, Tuula; Mäkitie, Antti

    2013-01-01

    The aim of this study was to develop and evaluate a digital process for manufacturing of occlusal splints. An alginate impression was taken from the upper and lower jaws of a patient with temporomandibular disorder owing to cross bite and wear of the teeth, and then digitized using a table laser scanner. The scanned model was repaired using the 3Data Expert software, and a splint was designed with the Viscam RP software. A splint was manufactured from a biocompatible liquid photopolymer by stereolithography. The system employed in the process was SLA 350. The splint was worn nightly for six months. The patient adapted to the splint well and found it comfortable to use. The splint relieved tension in the patient's bite muscles. No sign of tooth wear or significant splint wear was detected after six months of testing. Modern digital technology enables us to manufacture clinically functional occlusal splints, which might reduce costs, dental technician working time and chair-side time. Maximum-dimensional errors of approximately 1 mm were found at thin walls and sharp corners of the splint when compared with the digital model. PMID:23614943

  8. The Benefits of Including Clinical Factors in Rectal Normal Tissue Complication Probability Modeling After Radiotherapy for Prostate Cancer

    SciTech Connect

    Defraene, Gilles; Van den Bergh, Laura; Al-Mamgani, Abrahim; Haustermans, Karin; Heemsbergen, Wilma; Van den Heuvel, Frank; Lebesque, Joos V.

    2012-03-01

    Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including the most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011-0.013) clinical factor was 'previous abdominal surgery.' As second significant (p = 0.012-0.016) factor, 'cardiac history' was included in all three rectal bleeding fits, whereas including 'diabetes' was significant (p = 0.039-0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003-0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D{sub 50}. Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints. Conclusions: Comparable

  9. Can Vitamin D Supplementation in Addition to Asthma Controllers Improve Clinical Outcomes in Patients With Asthma?

    PubMed Central

    Luo, Jian; Liu, Dan; Liu, Chun-Tao

    2015-01-01

    Abstract Effects of vitamin D on acute exacerbation, lung function, and fraction of exhaled nitric oxide (FeNO) in patients with asthma are controversial. We aim to further evaluate the roles of vitamin D supplementation in addition to asthma controllers in asthmatics. From 1946 to July 2015, we searched the PubMed, Embase, Medline, Cochrane Central Register of Controlled Trials, and ISI Web of Science using “Vitamin D,” “Vit D,” or “VitD” and “asthma,” and manually reviewed the references listed in the identified articles. Randomized controlled trials which reported rate of asthma exacerbations and adverse events, forced expiratory volume in 1 s (FEV1, % of predicted value), FeNO, asthma control test (ACT), and serum 25-hydroxyvitamin D levels were eligible. We conducted the heterogeneities test and sensitivity analysis of the enrolled studies, and random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference for dichotomous and continuous data, respectively. Cochrane systematic review software Review Manager (RevMan) was used to test the hypothesis by Mann–Whitney U test, which were displayed in Forest plots. Seven trials with a total of 903 patients with asthma were pooled in our final studies. Except for asthma exacerbations (I2 = 81%, χ2 = 10.28, P = 0.006), we did not find statistical heterogeneity in outcome measures. The pooled RR of asthma exacerbation was 0.66 (95% confidence interval: 0.32–1.37), but without significant difference (z = 1.12, P = 0.26), neither was in FEV1 (z = 0.30, P = 0.77), FeNO (z = 0.28, P = 0.78), or ACT (z = 0.92, P = 0.36), although serum 25-hydroxyvitamin D was significantly increased (z = 6.16, P < 0.001). Vitamin D supplementation in addition to asthma controllers cannot decrease asthma exacerbation and FeNO, nor improve lung function and asthma symptoms, although it can be safely applied to increase serum 25

  10. Clinical benefits of combined chemotherapy with S-1, oxaliplatin, and docetaxel in advanced gastric cancer patients with palliative surgery

    PubMed Central

    Liu, Yan; Feng, Ye; Gao, Yongjian; Hou, Ruizhi

    2016-01-01

    Background and aim Advanced gastric cancer accounts for a substantial portion of cancer-related mortality worldwide. Surgical intervention is the curative therapeutic approach, but patients with advanced gastric cancer are not eligible for the radical resection. The present work aimed to investigate the efficacy and safety of palliative surgery combined with S-1, oxaliplatin, and docetaxel chemotherapy in the treatment of patients with advanced gastric cancer. Method A total of 20 patients who underwent palliative resection of gastric cancer in China–Japan Union Hospital of Jilin University from 2010 to 2011 were evaluated. Days 20–30 postoperative, these patients started to receive chemotherapy of S-1 (40 mg/m2, oral intake twice a day) and intravenous infusion of oxaliplatin (135 mg/m2) and docetaxel (75 mg/m2). After three cycles of chemotherapy (21 days/cycle), patients were evaluated, and only those who responded toward the treatment continued to receive six to eight cycles of the treatment and were included in end point evaluation. Patients’ survival time and adverse reactions observed along the treatment were compared with those treated with FOLFOX. Results Out of 20 patients evaluated, there was one case of complete response, nine cases of partial response, six cases of stable disease, and four cases of progressive disease. The total efficacy (complete response + partial response) and clinical benefit rates were 50% and 80%, respectively. Of importance, the treatment achieved a significantly longer survival time compared to FOLFOX, despite the fact that both regimens shared common adverse reactions. The adverse reactions were gastrointestinal reaction, reduction in white blood cells, and peripheral neurotoxicity. All of them were mild, having no impact on the treatment. Conclusion Combination therapy of S-1, oxaliplatin, and docetaxel improves the survival of gastric cancer patients treated with palliative resection, with adverse reactions being

  11. Experience of an incontinence clinic for older women: no apparent age limit for potential physical and psychological benefits.

    PubMed

    Tannenbaum, C; Bachand, G; Dubeau, C E; Kuchel, G A

    2001-10-01

    Urinary incontinence (UI) is a common but undertreated condition in older women. Although a variety of noninvasive interventions is available, older women may be hesitant to seek care for UI because of misconceptions about normal aging and treatment futility. We sought to evaluate the effectiveness of a UI clinic specifically tailored to the needs of older women to promote a sense of empowerment and to enhance satisfaction with treatment and outcome. We describe a case series of 52 women between the ages of 65 and 98 who were evaluated at the Geriatric Incontinence Clinic at the McGill University Health Centre over a 1-year period. A standardized telephone questionnaire was administered by a nurse consultant 6 months after each subject's final visit to assess patient satisfaction and current incontinence status. Forty-five women (86%) were available for telephone follow-up and completed the questionnaire. Mean age was 80 years, with urge incontinence in 45%, mixed incontinence (stress and urge) in 33%, impaired bladder emptying with urge symptoms in 10%, and other diagnoses in 12%. Overall, a mean reduction of 1.4 incontinent episodes per day was reported. At follow-up, 30% of the subjects reported being cured of their incontinence, 30% had improved, 20% were the same, and 20% were worse. Over 85% of all women reported satisfaction with their new incontinence status. Women of all ages, independent of the type of UI, type of treatment, and cognitive status, were able to achieve reductions in incontinence symptoms. All patients who had worsened were noncompliant with treatment recommendations at follow-up. Older women can derive significant benefit from a UI assessment. Neither advanced age nor category of incontinence precludes improvements or enhanced satisfaction with treatment. Efforts to improve targeting and compliance may improve outcomes. PMID:11703887

  12. Economic and clinical benefits of endometrial radiofrequency ablation compared with other ablation techniques in women with menorrhagia: a retrospective analysis with German health claims data

    PubMed Central

    Bischoff-Everding, Christoph; Soeder, Ruediger; Neukirch, Benno

    2016-01-01

    Objective To evaluate the economic and clinical benefits of endometrial radiofrequency ablation (RFA) compared with other ablation techniques for the treatment of menorrhagia. Methods Using German health claims data, women meeting defined inclusion criteria for the intervention group (RFA) were selected. A comparable control group (other endometrial ablations) was established using propensity score matching. These two groups were compared during the quarter of treatment (QoT) and a follow-up of 2 years for the following outcomes: costs during QoT and during follow-up, repeated menorrhagia diagnoses during follow-up and necessary retreatments during follow-up. Results After performing propensity score matching, 50 cases could be allocated to the intervention group, while 38 were identified as control cases. Patients in the RFA group had 5% fewer repeat menorrhagia diagnoses (40% vs 45%; not significant) and 5% fewer treatments associated with recurrent menorrhagia (6% vs 11%; not significant) than cases in the control group. During the QoT, the RFA group incurred €578 additional costs (€2,068 vs €1,490; ns). However, during follow-up, the control group incurred €1,254 additional costs (€4,561 vs €5,815; ns), with medication, outpatient physician consultations, and hospitals costs being the main cost drivers. However, none of the results were statistically significant. Conclusion Although RFA was more cost-intensive in the QoT compared with other endometrial ablation techniques, an average total savings of €676 was generated during the follow-up period. While having evidence that RFA is clinically equivalent to other endometrial ablation procedures, we generated indications that RFA is non-inferior and favorable with regard to economic outcomes. PMID:26848277

  13. Can repeat injection provide clinical benefit in patients with cervical disc herniation and stenosis when the first epidural injection results only in partial response?

    PubMed

    Lee, Jung Hwan; Lee, Sang-Ho

    2016-07-01

    Epidural steroid injection (ESI) is known to be an effective treatment for neck or radicular pain due to herniated intervertebral disc (HIVD) and spinal stenosis (SS). Although repeat ESI has generally been indicated to provide more pain relief in partial responders after single ESI, there has been little evidence supporting the usefulness of this procedure. The purpose of this study, therefore, was to determine whether repeat ESI at a prescribed interval of 2 to 3 weeks after the first injection would provide greater clinical benefit in patients with partial pain reduction than intermittent ESI performed only when pain was aggravated. One hundred eighty-four patients who underwent transforaminal ESI (TFESI) for treatment of axial neck and radicular arm pain due to HIVD or SS and could be followed up for 1 year were enrolled. We divided the patients into 2 groups. Group A (N = 108) comprised partial responders (numeric rating scale (NRS) ≥ 3 after the first injection) who underwent repeat injection at a prescribed interval of 2 to 3 weeks after the first injection. Group B (N = 76) comprised partial responders who did not receive repeat injection at the prescribed interval, but received intermittent injections only for aggravation of pain. Various clinical data were assessed, including total number of injections during 1 year, NRS duration of <3 during 1 year (NRS < 3 duration), and time interval until pain was increased to require additional injections after repeat injection in Group A, or after first injection in Group B (time to reinjection). Groups A and B were compared in terms of total population, HIVD, and SS. In the whole population, HIVD subgroup, and SS subgroup, patients in Group A required significantly fewer injections to obtain satisfactory pain relief during the 1-year follow-up period. Group A showed a significantly longer time to reinjection and longer NRS < 3 than Group B did. Repeat TFESI conducted at 2- to 3-week intervals

  14. 38 CFR 3.361 - Benefits under 38 U.S.C. 1151(a) for additional disability or death due to hospital care, medical...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS ADJUDICATION Pension, Compensation, and Dependency and Indemnity Compensation Ratings for Special Purposes § 3.361 Benefits under 38 U.S.C..., error in judgment, or similar instance of fault on VA's part in furnishing hospital care, medical...

  15. Is there a clinical benefit with a smooth compensator design compared with a plunged compensator design for passive scattered protons?

    PubMed

    Tabibian, Art A; Powers, Adam; Dolormente, Keith; Oommen, Sneha; Tiwari, Akhil; Palmer, Matt; Zhu, Xiaorong R; Li, Heng; Sahoo, Narayan; Wisdom, Paul; Velasco, Kyle; Erhart, Kevin; Stanley, Henry; Nguyen, Bao-Ngoc T

    2015-01-01

    In proton therapy, passive scattered proton plans use compensators to conform the dose to the distal surface of the planning volume. These devices are custom made from acrylic or wax for each treatment field using either a plunge-drilled or smooth-milled compensator design. The purpose of this study was to investigate if there is a clinical benefit of generating passive scattered proton radiation treatment plans with the smooth compensator design. We generated 4 plans with different techniques using the smooth compensators. We chose 5 sites and 5 patients for each site for the range of dosimetric effects to show adequate sample. The plans were compared and evaluated using multicriteria (MCA) plan quality metrics for plan assessment and comparison using the Quality Reports [EMR] technology by Canis Lupus LLC. The average absolute difference for dosimetric metrics from the plunged-depth plan ranged from -4.7 to +3.0 and the average absolute performance results ranged from -6.6% to +3%. The manually edited smooth compensator plan yielded the best dosimetric metric, +3.0, and performance, + 3.0% compared to the plunged-depth plan. It was also superior to the other smooth compensator plans. Our results indicate that there are multiple approaches to achieve plans with smooth compensators similar to the plunged-depth plans. The smooth compensators with manual compensator edits yielded equal or better target coverage and normal tissue (NT) doses compared with the other smooth compensator techniques. Further studies are under investigation to evaluate the robustness of the smooth compensator design.

  16. Is there a clinical benefit with a smooth compensator design compared with a plunged compensator design for passive scattered protons?

    SciTech Connect

    Tabibian, Art A.; Powers, Adam; Dolormente, Keith; Oommen, Sneha; Tiwari, Akhil; Palmer, Matt; Zhu, Xiaorong R.; Li, Heng; Sahoo, Narayan; Wisdom, Paul; Velasco, Kyle; Erhart, Kevin; Stanley, Henry; Nguyen, Bao-Ngoc T.

    2015-04-01

    In proton therapy, passive scattered proton plans use compensators to conform the dose to the distal surface of the planning volume. These devices are custom made from acrylic or wax for each treatment field using either a plunge-drilled or smooth-milled compensator design. The purpose of this study was to investigate if there is a clinical benefit of generating passive scattered proton radiation treatment plans with the smooth compensator design. We generated 4 plans with different techniques using the smooth compensators. We chose 5 sites and 5 patients for each site for the range of dosimetric effects to show adequate sample. The plans were compared and evaluated using multicriteria (MCA) plan quality metrics for plan assessment and comparison using the Quality Reports [EMR] technology by Canis Lupus LLC. The average absolute difference for dosimetric metrics from the plunged-depth plan ranged from −4.7 to +3.0 and the average absolute performance results ranged from −6.6% to +3%. The manually edited smooth compensator plan yielded the best dosimetric metric, +3.0, and performance, + 3.0% compared to the plunged-depth plan. It was also superior to the other smooth compensator plans. Our results indicate that there are multiple approaches to achieve plans with smooth compensators similar to the plunged-depth plans. The smooth compensators with manual compensator edits yielded equal or better target coverage and normal tissue (NT) doses compared with the other smooth compensator techniques. Further studies are under investigation to evaluate the robustness of the smooth compensator design.

  17. The effect of format on parents' understanding of the risks and benefits of clinical research: a comparison between text, tables, and graphics.

    PubMed

    Tait, Alan R; Voepel-Lewis, Terri; Zikmund-Fisher, Brian J; Fagerlin, Angela

    2010-07-01

    There is a paucity of information regarding the optimal method of presenting risk/benefit information to parents of pediatric research subjects. This study, therefore, was designed to examine the effect of different message formats on parents' understanding of research risks and benefits. An Internet-administered survey was completed by 4,685 parents who were randomized to receive risk/benefit information about a study of pediatric postoperative pain control presented in different message formats (text, tables, and pictographs). Survey questions assessed participants' gist and verbatim understanding of the information and their perceptions of the risks and benefits. Pictographs were associated with significantly (p < .05) greater likelihood of adequate gist and verbatim understanding compared with text and tables regardless of the participants' numeracy. Parents who received the information in pictograph format perceived the risks to be lower and the benefits to be higher compared with the other formats (p < .001). Furthermore, compared with text and tables, pictographs were perceived as more "effective," "helpful," and "trustworthy" in presenting risk/benefit information. These results underscore the difficulties associated with presenting risk/benefit information for clinical research but suggest a simple method for enhancing parents' informed understanding of the relevant statistics.

  18. 38 CFR 3.361 - Benefits under 38 U.S.C. 1151(a) for additional disability or death due to hospital care, medical...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., error in judgment, or similar instance of fault on VA's part in furnishing hospital care, medical or.... 1151(a) for additional disability or death due to hospital care, medical or surgical treatment.... 1151(a) for additional disability or death due to hospital care, medical or surgical...

  19. 38 CFR 3.361 - Benefits under 38 U.S.C. 1151(a) for additional disability or death due to hospital care, medical...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., error in judgment, or similar instance of fault on VA's part in furnishing hospital care, medical or.... 1151(a) for additional disability or death due to hospital care, medical or surgical treatment.... 1151(a) for additional disability or death due to hospital care, medical or surgical...

  20. 38 CFR 3.361 - Benefits under 38 U.S.C. 1151(a) for additional disability or death due to hospital care, medical...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... 1151(a) for additional disability or death due to hospital care, medical or surgical treatment.... 1151(a) for additional disability or death due to hospital care, medical or surgical treatment..., VA compares the veteran's condition immediately before the beginning of the hospital care, medical...

  1. 38 CFR 3.361 - Benefits under 38 U.S.C. 1151(a) for additional disability or death due to hospital care, medical...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    .... 1151(a) for additional disability or death due to hospital care, medical or surgical treatment.... 1151(a) for additional disability or death due to hospital care, medical or surgical treatment..., VA compares the veteran's condition immediately before the beginning of the hospital care, medical...

  2. Drug Signature-based Finding of Additional Clinical Use of LC28-0126 for Neutrophilic Bronchial Asthma

    PubMed Central

    Shin, Eunji; Lee, Yong Chul; Kim, So Ri; Kim, Soon Ha; Park, Joonghoon

    2015-01-01

    In recent decades, global pharmaceutical companies have suffered from an R&D innovation gap between the increased cost of a new drug’s development and the decreased number of approvals. Drug repositioning offers another opportunity to fill the gap because the approved drugs have a known safety profile for human use, allowing for a reduction of the overall cost of drug development by eliminating rigorous safety assessment. In this study, we compared the transcriptional profile of LC28-0126, an investigational drug for acute myocardial infarction (MI) at clinical trial, obtained from healthy male subjects with molecular activity profiles in the Connectivity Map. We identified dyphilline, an FDA-approved drug for bronchial asthma, as a top ranked connection with LC28-0126. Subsequently, we demonstrated that LC28-0126 effectively ameliorates the pathophysiology of neutrophilic bronchial asthma in OVALPS-OVA mice accompanied with a reduction of inflammatory cell counts in the bronchoalveolar lavage fluid (BALF), inhibition of the release of proinflammatory cytokines, relief of airway hyperactivity, and improvement of histopathological changes in the lung. Taken together, we suggest that LC28-0126 could be a potential therapeutic for bronchial asthma. In addition, this study demonstrated the potential general utility of computational drug repositioning using clinical profiles of the investigational drug. PMID:26626943

  3. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes

    PubMed Central

    Cook, Andrea J.; Wellman, Robert D.; Cherkin, Daniel C.; Kahn, Janet R.; Sherman, Karen J.

    2015-01-01

    Background Context This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of non-pharmacological treatments. Purpose To determine the optimal dose of massage for neck pain. Study Design/Setting Two-phase randomized trial for persons with chronic non-specific neck pain. Primary randomization to one of 5 groups receiving 4 weeks of massage (30 minutes 2×/ or 3×/week or 60 minutes 1×, 2×, or 3×/week). Booster randomization of participants to receive an additional 6 massages, 60 minute 1×/week, or no additional massage. Patient Sample 179 participants from Group Health and the general population of Seattle, WA USA recruited between June 2010 and August 2011. Outcome Measures Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0–10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as >5 point decrease in dysfunction and > 30% decrease in pain from baseline. Methods Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations. Secondary analyses for the continuous outcomes used linear generalized estimating equations. This study was funded the National Center for Complementary and Alternative Medicine, NIH, USA (R01 AT004411). The funders had no role in the interpretation or reporting of results. Results There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: RR=1.56(1.08–2.25), P=0.018; pain: RR=1.25(0.98–1.61); P=0.077), but those were non-significant at 26 weeks (dysfunction: RR=1.22(0.85–1.74); pain: RR=1.09(0.82–1.43)). Subgroup analysis by primary and booster treatments found the booster dose only

  4. Integrated NY-ESO-1 antibody and CD8+ T-cell responses correlate with clinical benefit in advanced melanoma patients treated with ipilimumab.

    PubMed

    Yuan, Jianda; Adamow, Matthew; Ginsberg, Brian A; Rasalan, Teresa S; Ritter, Erika; Gallardo, Humilidad F; Xu, Yinyan; Pogoriler, Evelina; Terzulli, Stephanie L; Kuk, Deborah; Panageas, Katherine S; Ritter, Gerd; Sznol, Mario; Halaban, Ruth; Jungbluth, Achim A; Allison, James P; Old, Lloyd J; Wolchok, Jedd D; Gnjatic, Sacha

    2011-10-01

    Ipilimumab, a monoclonal antibody against cytotoxic T lymphocyte antigen 4 (CTLA-4), has been shown to improve survival in patients with advanced metastatic melanoma. It also enhances immunity to NY-ESO-1, a cancer/testis antigen expressed in a subset of patients with melanoma. To characterize the association between immune response and clinical outcome, we first analyzed NY-ESO-1 serum antibody by ELISA in 144 ipilimumab-treated patients with melanoma and found 22 of 140 (16%) seropositive at baseline and 31 of 144 (22%) seropositive following treatment. These NY-ESO-1-seropositive patients had a greater likelihood of experiencing clinical benefit 24 wk after ipilimumab treatment than NY-ESO-1-seronegative patients (P = 0.02, relative risk = 1.8, two-tailed Fisher test). To understand why some patients with NY-ESO-1 antibody failed to experience clinical benefit, we analyzed NY-ESO-1-specific CD4(+) and CD8(+) T-cell responses by intracellular multicytokine staining in 20 NY-ESO-1-seropositive patients and found a surprising dissociation between NY-ESO-1 antibody and CD8 responses in some patients. NY-ESO-1-seropositive patients with associated CD8(+) T cells experienced more frequent clinical benefit (10 of 13; 77%) than those with undetectable CD8(+) T-cell response (one of seven; 14%; P = 0.02; relative risk = 5.4, two-tailed Fisher test), as well as a significant survival advantage (P = 0.01; hazard ratio = 0.2, time-dependent Cox model). Together, our data suggest that integrated NY-ESO-1 immune responses may have predictive value for ipilimumab treatment and argue for prospective studies in patients with established NY-ESO-1 immunity. The current findings provide a strong rationale for the clinical use of modulators of immunosuppression with concurrent approaches to favor tumor antigen-specific immune responses, such as vaccines or adoptive transfer, in patients with cancer.

  5. Exendin-4 therapy still offered an additional benefit on reducing transverse aortic constriction-induced cardiac hypertrophy-caused myocardial damage in DPP-4 deficient rats.

    PubMed

    Lu, Hung-I; Chung, Sheng-Ying; Chen, Yi-Ling; Huang, Tein-Hung; Zhen, Yen-Yi; Liu, Chu-Feng; Chang, Meng-Wei; Chen, Yung-Lung; Sheu, Jiunn-Jye; Chua, Sarah; Yip, Hon-Kan; Lee, Fan-Yen

    2016-01-01

    Inhibition of dipeptidyl peptidase-IV (DPP-4) enzyme activity has been revealed to protect myocardium from ischemia-reperfusion through enhancing the endogenous glucagon-like peptide-1 (GLP-1) level. However, whether exogenous supply of exendin-4, an analogue of GLP-1, would still offer benefit for protecting myocardial damage from trans-aortic constriction (TAC)-induced hypertrophic cardiomyopathy in preexistence of DPP-4 deficiency (DPP-4(D)) remained unclear. Male-adult (DPP-4(D)) rats (n = 32) were randomized into group 1 [sham control (SC)], group 2 (DPP-4(D) + TAC), group 3 [DPP-4(D) + TAC + exendin-4 10 µg/day], and group 4 [DPP-4(D) + TAC + exendin-4 10 µg + exendin-9-39 10 µg/day]. The rats were sacrificed by day 60 after last echocardiographic examination. By day 60 after TAC, left ventricular ejection fraction (LVEF) (%) was highest in group 1 and lowest in group 2, and significantly lower in group 4 than that in group 3 (all p < 0.001). The protein expressions of oxidative stress (oxidized protein, NOX-1, NOX-2), inflammatory (MMP-9, TNF-α, NF-κB), apoptotic (Bax, cleaved caspase 3 and PARP), fibrotic (TGF-β, Smad3), heart failure (BNP, β-MHC), DNA damaged (γ-H2AX) and ischemic stress (p-P38, p-Akt, p53, ATM) biomarkers showed an opposite pattern of LVEF among the four groups (all p < 0.03). Fibrotic area (by Masson's trichrome, Sirius red), and cellular expressions of DNA-damaged markers (Ki-67+, γ-H2AX+, CD90+/53BP1+) displayed an identical pattern, whereas cellular expressions of angiogenesis (CD31+, α-SMA+) and sarcomere length exhibited an opposite pattern compared to that of oxidative stress among the four groups (all p < 0.001). Take altogether, Exendin-4 effectively suppressed TAC-induced pathological cardiac hypertrophy in DPP-4(D) rat.

  6. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Safeguards for Children in Clinical Investigations § 50.53 Clinical investigations involving greater than... in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an... involve children as subjects only if the IRB finds and documents that: (a) The risk represents a...

  7. The Royal College of Physicians Simms Lecture, 6 December 2011: clinical research networks and the benefits of intensive healthcare systems.

    PubMed

    Selby, Peter; Kaplan, Richard; Cameron, David; Cooper, Matthew; Seymour, Matthew

    2012-10-01

    Clinical research contributes to the evidence base for the planning of improved healthcare services and creates an excellent environment for the delivery of healthcare and the recruitment and retention of excellent and well-motivated staff. In this paper, we consider the evidence that a research-intensive healthcare system might yield improved outcomes as a result of the impact of the process of research on the provision of care. We review progress in establishing clinical research networks for cancer and the evidence of the impact of the conduct of clinical cancer research in the National Health Service.

  8. Additional Survival Benefit of Involved-Lesion Radiation Therapy After R-CHOP Chemotherapy in Limited Stage Diffuse Large B-Cell Lymphoma

    SciTech Connect

    Kwon, Jeanny; Kim, Il Han; Kim, Byoung Hyuck; Kim, Tae Min; Heo, Dae Seog

    2015-05-01

    Purpose: The purpose of this study was to evaluate the role of involved-lesion radiation therapy (ILRT) after rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy in limited stage diffuse large B-cell lymphoma (DLBCL) by comparing outcomes of R-CHOP therapy alone with R-CHOP followed by ILRT. Methods and Materials: We identified 198 patients treated with R-CHOP (median, 6 cycles) for pathologically confirmed DLBCL of limited stage from July 2004 to December 2012. Clinical characteristics of these patients were 33% with stage I and 66.7% with stage II; 79.8% were in the low or low-intermediate risk group; 13.6% had B symptoms; 29.8% had bulky tumors (≥7 cm); and 75.3% underwent ≥6 cycles of R-CHOP therapy. RT was given to 43 patients (21.7%) using ILRT technique, which included the prechemotherapy tumor volume with a median margin of 2 cm (median RT dose: 36 Gy). Results: After a median follow-up of 40 months, 3-year progression-free survival (PFS) and overall survival (OS) were 85.8% and 88.9%, respectively. Multivariate analysis showed ≥6 cycles of R-CHOP (PFS, P=.004; OS, P=.004) and ILRT (PFS, P=.021; OS, P=.014) were favorable prognosticators of PFS and OS. A bulky tumor (P=.027) and response to R-CHOP (P=.012) were also found to be independent factors of OS. In subgroup analysis, the effect of ILRT was prominent in patients with a bulky tumor (PFS, P=.014; OS, P=.030) or an elevated level of serum lactate dehydrogenase (LDH; PFS, P=.004; OS, P=.012). Conclusions: Our results suggest that ILRT after R-CHOP therapy improves PFS and OS in patients with limited stage DLBCL, especially in those with bulky disease or an elevated serum LDH level.

  9. Using perceptual mapping methods to understand gender differences in perceived barriers and benefits of clinical research participation in urban minority HIV+ patients.

    PubMed

    Bass, Sarah Bauerle; Wolak, Caitlin; Greener, Judith; Tedaldi, Ellen; Nanavati, Aasit; Ruppert, Katey; Gordon, Thomas F

    2016-01-01

    Minority participation in HIV clinical trials research is critical to understanding the impact of medications or behavioral interventions, but little is known about gender differences in perceptions of participation. We surveyed 50 minority HIV+ patients from an urban clinic to assess perceived risks/benefits of clinical trial research participation and used innovative marketing methods to analyze results. Perceptual mapping and vector message-modeling, a method that creates 3-D models representing how groups conceptualize elements, were used to assess how male and female participants could be motivated to participate. Results showed men farther away from participation and more concerned with HIV disclosure and experimentation than women. Men expressed distrust of the medical system, doubted HIV's origin, and knew less about research implementation. Women were closer to participation in both behavior and medical trials and perceived medication issues as more significant, including fear of losing medication stability, medications not working, being in the placebo group, and experiencing side effects. Vector modeling shows that messages would need to focus on different aspects of clinical research for men and women and that interventions aimed at minority HIV+ patients to encourage clinical trial participation would need to be targeted to their unique perceptions. Understanding gender perceptions of HIV clinical research has significant implications for targeting messages to increase minority participation. PMID:26572215

  10. Using perceptual mapping methods to understand gender differences in perceived barriers and benefits of clinical research participation in urban minority HIV+ patients.

    PubMed

    Bass, Sarah Bauerle; Wolak, Caitlin; Greener, Judith; Tedaldi, Ellen; Nanavati, Aasit; Ruppert, Katey; Gordon, Thomas F

    2016-01-01

    Minority participation in HIV clinical trials research is critical to understanding the impact of medications or behavioral interventions, but little is known about gender differences in perceptions of participation. We surveyed 50 minority HIV+ patients from an urban clinic to assess perceived risks/benefits of clinical trial research participation and used innovative marketing methods to analyze results. Perceptual mapping and vector message-modeling, a method that creates 3-D models representing how groups conceptualize elements, were used to assess how male and female participants could be motivated to participate. Results showed men farther away from participation and more concerned with HIV disclosure and experimentation than women. Men expressed distrust of the medical system, doubted HIV's origin, and knew less about research implementation. Women were closer to participation in both behavior and medical trials and perceived medication issues as more significant, including fear of losing medication stability, medications not working, being in the placebo group, and experiencing side effects. Vector modeling shows that messages would need to focus on different aspects of clinical research for men and women and that interventions aimed at minority HIV+ patients to encourage clinical trial participation would need to be targeted to their unique perceptions. Understanding gender perceptions of HIV clinical research has significant implications for targeting messages to increase minority participation.

  11. Tantalum trabecular metal - addition of human skeletal cells to enhance bone implant interface strength and clinical application.

    PubMed

    Smith, J O; Sengers, B G; Aarvold, A; Tayton, E R; Dunlop, D G; Oreffo, R O C

    2014-04-01

    The osteo-regenerative properties of allograft have recently been enhanced by addition of autogenous human bone marrow stromal cells (HBMSCs). Limitations in the use of allograft have prompted the investigation of tantalum trabecular metal (TTM) as a potential alternative. TTM is already in widespread orthopaedic use, although in applications where there is poor initial stability, or when TTM is used in conjunction with bone grafting, initial implant loading may need to be limited. The aim of this study was to evaluate the osteo-regenerative potential of TTM with HBMSCs, in direct comparison to human allograft and autograft. HBMSCs were cultured on blocks of TTM, allograft or autograft in basal and osteogenic media. Molecular profiling, confocal and scanning electron microscopy (SEM) and biochemical assays were used to characterize cell adherence, proliferation and phenotype. Mechanical testing was used to define the tensile characteristics of the constructs. HBMSCs displayed adherence and proliferation throughout TTM, evidenced by immunocytochemistry and SEM, with significant cellular ingrowth and matrix production through TTM. In contrast to cells cultured with allograft, cell proliferation assays showed significantly higher activity with TTM (p < 0.001), although molecular profiling confirmed no significant difference in expression of osteogenic genes. In contrast to acellular constructs, mechanical testing of cell-TTM constructs showed enhanced tensile characteristics, which compared favourably to cell-allograft constructs. These studies demonstrated the ability of TTM to support HBMSC growth and osteogenic differentiation comparable to allograft. Thus, TTM represents an alternative to allograft for osteo-regenerative strategies, extending its clinical applications as a substitute for allograft.

  12. Aortic arch calcification on chest X-ray combined with coronary calcium score show additional benefit for diagnosis and outcome in patients with angina

    PubMed Central

    Woo, Jong Shin; Kim, Weon; Kwon, Se Hwan; Youn, Hyo Chul; Kim, Hyun Soo; Kim, Jin Bae; Kim, Soo Joong; Kim, Woo-Shik; Kim, Kwon Sam

    2016-01-01

    Background The coronary artery calcium (CAC) and aortic arch calcification (AoAC) are individually associated with cardiovascular disease and outcome. This study investigated the predictive value of AoAC combined with CAC for cardiovascular diagnosis and outcome in patients with angina. Methods A total of 2018 stable angina patients who underwent chest X-ray and cardiac multi-detector computed tomography were followed up for four years to assess adverse events, which were categorized as cardiac death, stroke, myocardial infarction, or repeated revascularization. The extent of AoAC on chest X-ray was graded on a scale from 0 to 3. Results During the four years of follow-up, 620 patients were treated by coronary stenting and 153 (7%) adverse events occurred. A higher grade of AoAC was associated with a higher CAC score. Cox regression showed that the CAC score, but not AoAC, were associated with adverse events. In patients with CAC score < 400, AoAC showed an additive predictive value in detecting significant coronary artery disease (CAD). A gradual increases in the risk of adverse events were noted if AoAC was present in patients with similar CAC score. Conclusions As AoAC is strongly correlated with the CAC score regardless of age or gender, careful evaluation of CAD would be required in patients with AoAC on conventional chest X-rays. PMID:27103916

  13. The electrochemical reactions of pure In with Li and Na: anomalous electrolyte decomposition, benefits of FEC additive, phase transitions and electrode performance

    SciTech Connect

    Hawks, Samantha A; Baggetto, Loic; Bridges, Craig A; Veith, Gabriel M

    2014-01-01

    Indium thin films are evaluated as an anode material for Li-ion and Na-ion batteries (theoretical capacities of 1012 mAh g-1 for Li and 467 mAh g-1 for Na). The native surface oxides are responsible for the anomalous electrolyte decomposition during the first cycle while oxidized In species are found to be responsible for the electrolyte decomposition during the subsequent cycles. The presence of 5wt% FEC electrolyte additive suppresses the occurrence of the anomalous electrolyte decomposition during the first cycle but is not sufficient to prevent the decomposition upon further cycling from 0 to 2 V. Prevention of the anomalous decomposition can be achieved by restricting the charge cut-off, for instance at 1.1 V, or by using larger amounts of FEC. The In films show moderately good capacity retention with storage capacities when cycled with Li (950 mAh g-1) but significantly less when cycled with Na (125 mAh g-1). XRD data reveal that several known Li-In phases (i.e LiIn, Li3In2, LiIn2 and Li13In3) form during the electrochemical reaction. In contrast, the reaction with Na is severely limited. The largest amount of inserted Na is evidenced for cells short-circuited 40 hrs at 65C, for which the XRD data show the coexistence of NaIn, In, and an unknown phase. During cycling, mechanical degradation due to repeated expansion/shrinkage, evidenced by SEM, coupled with SEI formation is the primary source of the capacity fade. Finally, we show that the In thin films exhibit very high rate capability for both Li (100 C) and Na (30 C).

  14. Routine chest radiographs in the surgical intensive care unit: can we change clinical habits with no proven benefit?

    PubMed

    Velicković, Jelena V; Hajdarević, Sanela A; Palibrk, Ivan G; Janić, Natasa R; Djukanović, Marija; Miljković, Bojana; Velicković, Dejan M; Bumbasirević, Vesna

    2013-01-01

    Daily routine chest radiographs (CR) are commonly performed in surgical ICU. Unnecessary CR increase costs and expose the staff and the patients to radiation risk. The goal of our study was to estimate the value of daily routine CR in the ICU and to determine the correlation between CR and physical findings in surgical ICU patients. Prospective observational study was conducted during period of two months at the ICU department at the Clinic for Digestive Surgery, Clinical Center of Serbia, Belgrade. It included 97 consecutive patients who underwent digestive surgery and stayed at the ICU for at least two days. During their ICU stay, CRs were obtained as a clinical routine or to monitor lung pathology. Patients were followed daily, and CRs (as the proportion of positive findings) were compared with physical examination and clinical presentation. A total of 717 CRs were obtained, median number per patient was 4.0 (2.0-7.0). Proportion of positive findings was significantly higher comparing to auscultation until the sixth day of ICU stay. There was no difference in CR findings from day to day after the sixth day. Therapeutic efficacy of CRs was low as only 56 (7.8%) resulted in a change of patient management. We conclude that daily routine CRs are justified in the first six days of ICU stay, and after that time they show no advantages over clinical examination. PMID:24669579

  15. Lack of radiological and clinical benefit over two years of low dose prednisolone for rheumatoid arthritis: results of a randomised controlled trial

    PubMed Central

    Capell, H; Madhok, R; Hunter, J; Porter, D; Morrison, E; Larkin, J; Thomson, E; Hampson, R; Poon, F

    2004-01-01

    Background: Evidence for disease modifying activity of low dose corticosteroid treatment in rheumatoid arthritis is contradictory. Studies showing radiological benefit suggest that continued treatment is required to sustain the effect. Objective: To evaluate the effect of low dose oral prednisolone in early rheumatoid arthritis on disease activity over two years. Design: Double blind placebo controlled trial. Methods: Patients with rheumatoid arthritis, duration <3 years (n = 167), were started on a disease modifying antirheumatic drug (DMARD; sulphasalazine) and allocated by stratified randomisation to prednisolone 7 mg/day or placebo. Primary outcome measure was radiological damage, assessed by the modified Sharp method. Clinical benefit was a secondary outcome. A proactive approach to identifying and treating corticosteroid adverse events was adopted. Patients who discontinued sulphasalazine were offered an alternative DMARD. Results: 90 of 257 patients eligible for the study refused to participate (more women than men). Of those enrolled, 84% were seropositive for rheumatoid factor, median age 56 years, median disease duration 12 months, female to male ratio 1.8:1. Prednisolone was given to 84 patients; of these 73% continued prednisolone and 70% sulphasalazine at 2 years. Of the 83 patients on placebo, 80% continued placebo and 64% sulphasalazine at 2 years. There were no significant differences in radiological score or clinical and laboratory measures at 0 and 2 years. Conclusions: Low dose prednisolone conferred no radiological or clinical benefit on patients maintained on a DMARD over two years. Low dose corticosteroids have no role in the routine management of rheumatoid arthritis treated with conventional disease modifying drugs. PMID:15194574

  16. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... knowledge about the subjects' disorder or condition. 50.53 Section 50.53 Food and Drugs FOOD AND DRUG... knowledge about the subjects' disorder or condition. Any clinical investigation within the scope described... knowledge about the subjects' disorder or condition that is of vital importance for the understanding...

  17. The Benefits of Multidisciplinary Learning in Clinical Practice for Law, Finance, and Social Work Students: An Australian Experience

    ERIC Educational Resources Information Center

    Hyams, Ross; Brown, Grace; Foster, Richard

    2013-01-01

    In July 2010, the faculties of Law, Business and Economics, and Medicine at Monash University, Australia commenced placing law, finance, and social work students in a multidisciplinary clinic at a community legal service operated by the University. Students from the three disciplines began seeing legal service clients at the same time as a team.…

  18. Addressing the expected survival benefit for clinical trial design in metastatic castration-resistant prostate cancer: Sensitivity analysis of randomized trials.

    PubMed

    Massari, Francesco; Modena, Alessandra; Ciccarese, Chiara; Pilotto, Sara; Maines, Francesca; Bracarda, Sergio; Sperduti, Isabella; Giannarelli, Diana; Carlini, Paolo; Santini, Daniele; Tortora, Giampaolo; Porta, Camillo; Bria, Emilio

    2016-02-01

    We performed a sensitivity analysis, cumulating all randomized clinical trials (RCTs) in which patients with metastatic castration-resistant prostate cancer (mCRPC) received systemic therapy, to evaluate if the comparison of RCTs may drive to biased survival estimations. An overall survival (OS) significant difference according to therapeutic strategy was more likely be determined in RCTs evaluating hormonal drugs versus those studies testing immunotherapy, chemotherapy or other strategies. With regard to control arm, an OS significant effect was found for placebo-controlled trials versus studies comparing experimental treatment with active therapies. Finally, regarding to docetaxel (DOC) timing, the OS benefit was more likely to be proved in Post-DOC setting in comparison with DOC and Pre-DOC. These data suggest that clinical trial design should take into account new benchmarks such as the type of treatment strategy, the choice of the comparator and the phase of the disease in relation to the administration of standard chemotherapy.

  19. Rapid diagnostics of tuberculosis and drug resistance in the industrialized world: clinical and public health benefits and barriers to implementation

    PubMed Central

    2013-01-01

    In this article, we give an overview of new technologies for the diagnosis of tuberculosis (TB) and drug resistance, consider their advantages over existing methodologies, broad issues of cost, cost-effectiveness and programmatic implementation, and their clinical as well as public health impact, focusing on the industrialized world. Molecular nucleic-acid amplification diagnostic systems have high specificity for TB diagnosis (and rifampicin resistance) but sensitivity for TB detection is more variable. Nevertheless, it is possible to diagnose TB and rifampicin resistance within a day and commercial automated systems make this possible with minimal training. Although studies are limited, these systems appear to be cost-effective. Most of these tools are of value clinically and for public health use. For example, whole genome sequencing of Mycobacterium tuberculosis offers a powerful new approach to the identification of drug resistance and to map transmission at a community and population level. PMID:23987891

  20. Digital management and regulatory submission of medical images from clinical trials: role and benefits of the core laboratory

    NASA Astrophysics Data System (ADS)

    Robbins, William L.; Conklin, James J.

    1995-10-01

    Medical images (angiography, CT, MRI, nuclear medicine, ultrasound, x ray) play an increasingly important role in the clinical development and regulatory review process for pharmaceuticals and medical devices. Since medical images are increasingly acquired and archived digitally, or are readily digitized from film, they can be visualized, processed and analyzed in a variety of ways using digital image processing and display technology. Moreover, with image-based data management and data visualization tools, medical images can be electronically organized and submitted to the U.S. Food and Drug Administration (FDA) for review. The collection, processing, analysis, archival, and submission of medical images in a digital format versus an analog (film-based) format presents both challenges and opportunities for the clinical and regulatory information management specialist. The medical imaging 'core laboratory' is an important resource for clinical trials and regulatory submissions involving medical imaging data. Use of digital imaging technology within a core laboratory can increase efficiency and decrease overall costs in the image data management and regulatory review process.

  1. The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator.

    PubMed

    Quesada, Aurelio; Almendral, Jesús; Arribas, Fernando; Ricci, Renato; Wolpert, Christian; Adragao, Pedro; Cobo, Eric; Navarro, Xavier

    2004-03-01

    Single chamber (SC) implantable cardioverter defibrillators (ICDs) have several limitations that might be relevant during follow-up, like atrial pacing requirements, inadequate therapies, sustained atrial tachyarrhythmias and difficulties to achieve an accurate diagnosis of the arrhythmia. Dual chamber (DC) ICDs offer an attractive and rational solution, although controversy remains if the costs and complexity of these devices offer a real clinical advantage. The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of DC ICD, DDED, to reduce clinically significant adverse events compared with SC ICD in a non-selected population with conventional indications for ICD implantation. This is a prospective, multicentre, randomized, open labelled study, with three arms: two of them (simulated SC ICD and true DC ICD) cross-over, and the third (true SC ICD) parallels the other two. The composite primary end point comprises four Clinically Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention, hospitalization or prolongation of hospitalization due to cardiovascular cause, (3) inappropriate shocks, and (4) sustained symptomatic atrial tachyarrhythmias that (a) require urgent termination or (b) last more than 48h leading to therapeutic intervention. Secondary end points constitute each of the individual components of CSAE, cardiovascular status, quality of life and a detailed analysis of atrial and ventricular arrhythmias. To date (June 2003) there have been 343 patients enroled from 947 screened patients. The projected enrollment includes 360 patients and the conclusion of the study is expected at the beginning of 2005.

  2. EDTA chelation reappraisal following new clinical trials and regular use in millions of patients: review of preliminary findings and risk/benefit assessment.

    PubMed

    Born, Tammy; Kontoghiorghe, Christina N; Spyrou, Aspasia; Kolnagou, Annita; Kontoghiorghes, George J

    2013-01-01

    EDTA chelation therapy is regularly used in thousands of patients worldwide. An FDA approval of more than 50 years ago for heavy metal detoxification prompted many physicians to use EDTA as an alternative medicine for many categories of patients. Recently, NIH initiated the so-called Trial to Assess Chelation Therapy (TACT), which has been designed to evaluate whether EDTA and high dose oral vitamins and mineral therapy could offer clinical, quality of life, and economic benefits for patients with a previous myocardial infraction. A 50% reduction of urinary Pb and improvement of systolic blood pressure was observed in 33 cardiovascular patients following 20 iv administrations. In another study involving 15 patients of different categories, EDTA also has been shown to be an effective and nontoxic chelator for the removal of xenobiotic metals such as Pb, Cd, Ni and Al. Administration of iv EDTA on weekly basis appears to be a sufficient and nontoxic protocol for treating patients with suspected overload and toxicity of xenobiotic metals especially Pb and Cd. The causative effect of xenobiotic metals in cancer, cardiovascular, neurodegenerative, renal and other diseases needs further investigation. Similarly, the use of EDTA chelation therapy in other conditions, which are not related to xenobiotic metal toxicity needs further investigation and confirmation of therapeutic use from controlled randomized clinical trials. Metal balance and drug interaction studies are required to clarify the risk/benefit assessment for the long term use of EDTA in patients with excess xenobiotic metal toxicity and in other conditions.

  3. EDTA chelation reappraisal following new clinical trials and regular use in millions of patients: review of preliminary findings and risk/benefit assessment.

    PubMed

    Born, Tammy; Kontoghiorghe, Christina N; Spyrou, Aspasia; Kolnagou, Annita; Kontoghiorghes, George J

    2013-01-01

    EDTA chelation therapy is regularly used in thousands of patients worldwide. An FDA approval of more than 50 years ago for heavy metal detoxification prompted many physicians to use EDTA as an alternative medicine for many categories of patients. Recently, NIH initiated the so-called Trial to Assess Chelation Therapy (TACT), which has been designed to evaluate whether EDTA and high dose oral vitamins and mineral therapy could offer clinical, quality of life, and economic benefits for patients with a previous myocardial infraction. A 50% reduction of urinary Pb and improvement of systolic blood pressure was observed in 33 cardiovascular patients following 20 iv administrations. In another study involving 15 patients of different categories, EDTA also has been shown to be an effective and nontoxic chelator for the removal of xenobiotic metals such as Pb, Cd, Ni and Al. Administration of iv EDTA on weekly basis appears to be a sufficient and nontoxic protocol for treating patients with suspected overload and toxicity of xenobiotic metals especially Pb and Cd. The causative effect of xenobiotic metals in cancer, cardiovascular, neurodegenerative, renal and other diseases needs further investigation. Similarly, the use of EDTA chelation therapy in other conditions, which are not related to xenobiotic metal toxicity needs further investigation and confirmation of therapeutic use from controlled randomized clinical trials. Metal balance and drug interaction studies are required to clarify the risk/benefit assessment for the long term use of EDTA in patients with excess xenobiotic metal toxicity and in other conditions. PMID:22991933

  4. Benefits of post-operative oral protein supplementation in gastrointestinal surgery patients: A systematic review of clinical trials

    PubMed Central

    Crickmer, Mike; Dunne, Colum P; O’Regan, Andrew; Coffey, J Calvin; Dunne, Suzanne S

    2016-01-01

    AIM: To evaluate published trials examining oral post-operative protein supplementation in patients having undergone gastrointestinal surgery and assessment of reported results. METHODS: Database searches (MEDLINE, BIOSIS, EMBASE, Cochrane Trials, Cinahl, and CAB), searches of reference lists of relevant papers, and expert referral were used to identify prospective randomized controlled clinical trials. The following terms were used to locate articles: “oral’’ or “enteral’’ and “postoperative care’’ or “post-surgical’’ and “proteins’’ or “milk proteins’’ or “dietary proteins’’ or “dietary supplements’’ or “nutritional supplements’’. In databases that allowed added limitations, results were limited to clinical trials that studied humans, and publications between 1990 and 2014. Quality of collated studies was evaluated using a qualitative assessment tool and the collective results interpreted. RESULTS: Searches identified 629 papers of which, following review, 7 were deemed eligible for qualitative evaluation. Protein supplementation does not appear to affect mortality but does reduce weight loss, and improve nutritional status. Reduction in grip strength deterioration was observed in a majority of studies, and approximately half of the studies described reduced complication rates. No changes in duration of hospital stay or plasma protein levels were reported. There is evidence to suggest that protein supplementation should be routinely provided post-operatively to this population. However, despite comprehensive searches, clinical trials that varied only the amount of protein provided via oral nutritional supplements (discrete from other nutritional components) were not found. At present, there is some evidence to support routinely prescribed oral nutritional supplements that contain protein for gastrointestinal surgery patients in the immediate post-operative stage. CONCLUSION: The optimal level of protein

  5. The Clinical and Economic Benefits of Co-Testing Versus Primary HPV Testing for Cervical Cancer Screening: A Modeling Analysis

    PubMed Central

    Felix, Juan C.; Lacey, Michael J.; Lenhart, Gregory M.; Spitzer, Mark; Kulkarni, Rucha

    2016-01-01

    Abstract Background: Consensus United States cervical cancer screening guidelines recommend use of combination Pap plus human papillomavirus (HPV) testing for women aged 30 to 65 years. An HPV test was approved by the Food and Drug Administration in 2014 for primary cervical cancer screening in women age 25 years and older. Here, we present the results of clinical-economic comparisons of Pap plus HPV mRNA testing including genotyping for HPV 16/18 (co-testing) versus DNA-based primary HPV testing with HPV 16/18 genotyping and reflex cytology (HPV primary) for cervical cancer screening. Methods: A health state transition (Markov) model with 1-year cycling was developed using epidemiologic, clinical, and economic data from healthcare databases and published literature. A hypothetical cohort of one million women receiving triennial cervical cancer screening was simulated from ages 30 to 70 years. Screening strategies compared HPV primary to co-testing. Outcomes included total and incremental differences in costs, invasive cervical cancer (ICC) cases, ICC deaths, number of colposcopies, and quality-adjusted life years for cost-effectiveness calculations. Comprehensive sensitivity analyses were performed. Results: In a simulation cohort of one million 30-year-old women modeled up to age 70 years, the model predicted that screening with HPV primary testing instead of co-testing could lead to as many as 2,141 more ICC cases and 2,041 more ICC deaths. In the simulation, co-testing demonstrated a greater number of lifetime quality-adjusted life years (22,334) and yielded $39.0 million in savings compared with HPV primary, thereby conferring greater effectiveness at lower cost. Conclusions: Model results demonstrate that co-testing has the potential to provide improved clinical and economic outcomes when compared with HPV primary. While actual cost and outcome data are evaluated, these findings are relevant to U.S. healthcare payers and women's health policy advocates

  6. Prospective assessment of a gene signature potentially predictive of clinical benefit in metastatic melanoma patients following MAGE-A3 immunotherapeutic (PREDICT)

    PubMed Central

    Saiag, P.; Gutzmer, R.; Ascierto, P. A.; Maio, M.; Grob, J.-J.; Murawa, P.; Dreno, B.; Ross, M.; Weber, J.; Hauschild, A.; Rutkowski, P.; Testori, A.; Levchenko, E.; Enk, A.; Misery, L.; Vanden Abeele, C.; Vojtek, I.; Peeters, O.; Brichard, V. G.; Therasse, P.

    2016-01-01

    Background Genomic profiling of tumor tissue may aid in identifying predictive or prognostic gene signatures (GS) in some cancers. Retrospective gene expression profiling of melanoma and non-small-cell lung cancer led to the characterization of a GS associated with clinical benefit, including improved overall survival (OS), following immunization with the MAGE-A3 immunotherapeutic. The goal of the present study was to prospectively evaluate the predictive value of the previously characterized GS. Patients and methods An open-label prospective phase II trial (‘PREDICT’) in patients with MAGE-A3-positive unresectable stage IIIB-C/IV-M1a melanoma. Results Of 123 subjects who received the MAGE-A3 immunotherapeutic, 71 (58.7%) displayed the predictive GS (GS+). The 1-year OS rate was 83.1%/83.3% in the GS+/GS− populations. The rate of progression-free survival at 12 months was 5.8%/4.1% in GS+/GS− patients. The median time-to-treatment failure was 2.7/2.4 months (GS+/GS−). There was one complete response (GS−) and two partial responses (GS+). The MAGE-A3 immunotherapeutic was similarly immunogenic in both populations and had a clinically acceptable safety profile. Conclusion Treatment of patients with MAGE-A3-positive unresectable stage IIIB-C/IV-M1a melanoma with the MAGE-A3 immunotherapeutic demonstrated an overall 1-year OS rate of 83.5%. GS− and GS+ patients had similar 1-year OS rates, indicating that in this study, GS was not predictive of outcome. Unexpectedly, the objective response rate was lower in this study than in other studies carried out in the same setting with the MAGE-A3 immunotherapeutic. Investigation of a GS to predict clinical benefit to adjuvant MAGE-A3 immunotherapeutic treatment is ongoing in another melanoma study. This study is registered at www.clinicatrials.gov NCT00942162. PMID:27502712

  7. Clinical Benefits of Systemic Chemotherapy for Patients with Metastatic Pheochromocytomas or Sympathetic Extra-Adrenal Paragangliomas: Insights from the Largest Single Institutional Experience

    PubMed Central

    Ayala-Ramirez, Montserrat; Feng, Lei; Habra, Mouhammed A.; Rich, Thereasa; Dickson, Paxton V.; Perrier, Nancy; Phan, Alexandria; Waguespack, Steven; Patel, Shreyaskumar; Jimenez, Camilo

    2013-01-01

    Background The purpose of this study was to evaluate the clinical benefits of systemic chemotherapy for patients with metastatic pheochromocytomas or sympathetic paragangliomas by assessing reduction in tumor size, blood pressure, and improvement in overall survival. Methods We retrospectively reviewed the medical records of patients with metastatic pheochromocytomas-sympathetic paragangliomas who had received chemotherapy at The University of Texas MD Anderson Cancer Center Results Clinical benefit and overall survival (OS) were assessed. Of fifty-four patients treated with chemotherapy, fifty-two were evaluable for response. Seventeen (33%) experienced a response, defined as decreased or normalized blood pressure/decreased number and dosage of antihypertensive medications and/or reduced tumor size after the first chemotherapy regimen. The median OS time was 6.4 years (95 confidence interval (CI): 5.2–16.4) for responders and 3.7 (95% CI: 3.0–7.5) years for non-responders. Of patients who had synchronous metastatic disease, a positive response at 1 year after the start of chemotherapy was associated with a trend toward a longer overall survival (log-rank test, P-value =0.095). In a multivariate Cox proportional hazards model, the effect of response to chemotherapy on overall survival was significant (hazard ratio=0.22, 95% confidence interval: 0.05–1.0; P-value = 0.05). All responders had been treated with dacarbazine and cyclophosphamide. Vincristine was included for 14 responders and doxorubicin was included for 12 responders. We could not identify clinical factors that predicted response to chemotherapy. Conclusion Chemotherapy may decrease tumor size and facilitate blood pressure control in about 33% of patients with metastatic pheochromocytoma-sympathetic paraganglioma. These patients exhibit a longer survival. PMID:22006217

  8. Short‐Term Efficacy Reliably Predicts Long‐Term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model‐Based Meta‐Analysis

    PubMed Central

    Zhu, Rui; Xiao, Jim; Davis, John C.; Mandema, Jaap W.; Jin, Jin Y.; Tang, Meina T.

    2015-01-01

    Abstract The objective of this study was to assess the relationship between short‐term and long‐term treatment effects measured by the American College of Rheumatology (ACR) 50 responses and to assess the feasibility of predicting 6‐month efficacy from short‐term data. A rheumatoid arthritis (RA) database was constructed from 68 reported trials. We focused on the relationship between 3‐ and 6‐month ACR50 treatment effects and developed a generalized nonlinear model to quantify the relationship and test the impact of covariates. The ΔACR50 at 6 months strongly correlated with that at 3 months, moderately correlated with that at 2 months, and only weakly correlated with results obtained at <2 months. A scaling factor that reflected the ratio of 6‐ to 3‐month treatment effects was estimated to be 0.997, suggesting that the treatment effects at 3 months are approaching a “plateau.” Drug classes, baseline Disease Activity Score in 28 Joints, and the magnitude of control arm response did not show significant impacts on the scaling factor. This work quantitatively supports the empirical clinical development paradigm of using 3‐month efficacy data to predict long‐term efficacy and to inform the probability of clinical success based on early efficacy readout. PMID:26517752

  9. [Benefit assessment of drugs].

    PubMed

    Kaiser, Thomas; Vervölgyi, V; Wieseler, B

    2015-03-01

    In Germany, new drugs are subject to a benefit assessment at the time of their market access. This "early benefit assessment" is the method primarily used for the benefit assessment of pharmaceuticals in Germany. While for the authorization of a drug a positive risk-benefit ratio is sufficient, early benefit assessment examines whether the new drug has an added benefit compared with other therapies, and thus differs significantly from authorization. For the evaluation, the manufacturer is required to submit a dossier, which must contain all the relevant studies. Early benefit assessment is very transparent in international comparisons, because all the relevant data and the evaluation report will be published. The assessment is carried out with regard to the evidence-based standard of care (the "appropriate comparator"). If the new drug is found to have an additional benefit, the extent of this added benefit is assessed. In addition, groups of patients should be identified with the particular extent of the added benefit. Therefore, subgroup analyses have to be carried out frequently. Often, for new drugs, only registration studies are available. General requirements for such studies (e.g., placebo comparison, endpoints) and decisions regarding the approval process (e.g., dosage regimens) can affect the level of confidence of these studies in the benefit assessment. Joint scientific advice by regulatory authorities and HTA (health technology assessment) agencies are provided to solve this problem. However, this is not possible without additional expense for the pharmaceutical companies. PMID:25566842

  10. Feasibility of resistance training in adult McArdle patients: clinical outcomes and muscle strength and mass benefits

    PubMed Central

    Santalla, Alfredo; Munguía-Izquierdo, Diego; Brea-Alejo, Lidia; Pagola-Aldazábal, Itziar; Díez-Bermejo, Jorge; Fleck, Steven J.; Ara, Ignacio; Lucia, Alejandro

    2014-01-01

    We analyzed the effects of a 4-month resistance (weight lifting) training program followed by a 2-month detraining period in 7 adult McArdle patients (5 female) on: muscle mass (assessed by DXA), strength, serum creatine kinase (CK) activity and clinical severity. Adherence to training was ≥84% in all patients and no major contraindication or side effect was noted during the training or strength assessment sessions. The training program had a significant impact on total and lower extremities’ lean mass (P < 0.05 for the time effect), with mean values increasing with training by +855 g (95% confidence interval (CI): 30, 1679) and +547 g (95%CI: 116, 978), respectively, and significantly decreasing with detraining. Body fat showed no significant changes over the study period. Bench press and half-squat performance, expressed as the highest value of average muscle power (W) or force (N) in the concentric-repetition phase of both tests showed a consistent increase over the 4-month training period, and decreased with detraining. Yet muscle strength and power detraining values were significantly higher than pre-training values, indicating that a training effect was still present after detraining. Importantly, all the participants, with no exception, showed a clear gain in muscle strength after the 4-month training period, e.g., bench press: +52 W (95% CI: 13, 91); half-squat: +173 W (95% CI: 96, 251). No significant time effect (P > 0.05) was noted for baseline or post strength assessment values of serum CK activity, which remained essentially within the range reported in our laboratory for McArdle patients. All the patients changed to a lower severity class with training, such that none of them were in the highest disease severity class (3) after the intervention and, as such, they did not have fixed muscle weakness after training. Clinical improvements were retained, in all but one patient, after detraining, such that after detraining all patients were classed as

  11. Feasibility of resistance training in adult McArdle patients: clinical outcomes and muscle strength and mass benefits.

    PubMed

    Santalla, Alfredo; Munguía-Izquierdo, Diego; Brea-Alejo, Lidia; Pagola-Aldazábal, Itziar; Díez-Bermejo, Jorge; Fleck, Steven J; Ara, Ignacio; Lucia, Alejandro

    2014-01-01

    We analyzed the effects of a 4-month resistance (weight lifting) training program followed by a 2-month detraining period in 7 adult McArdle patients (5 female) on: muscle mass (assessed by DXA), strength, serum creatine kinase (CK) activity and clinical severity. Adherence to training was ≥84% in all patients and no major contraindication or side effect was noted during the training or strength assessment sessions. The training program had a significant impact on total and lower extremities' lean mass (P < 0.05 for the time effect), with mean values increasing with training by +855 g (95% confidence interval (CI): 30, 1679) and +547 g (95%CI: 116, 978), respectively, and significantly decreasing with detraining. Body fat showed no significant changes over the study period. Bench press and half-squat performance, expressed as the highest value of average muscle power (W) or force (N) in the concentric-repetition phase of both tests showed a consistent increase over the 4-month training period, and decreased with detraining. Yet muscle strength and power detraining values were significantly higher than pre-training values, indicating that a training effect was still present after detraining. Importantly, all the participants, with no exception, showed a clear gain in muscle strength after the 4-month training period, e.g., bench press: +52 W (95% CI: 13, 91); half-squat: +173 W (95% CI: 96, 251). No significant time effect (P > 0.05) was noted for baseline or post strength assessment values of serum CK activity, which remained essentially within the range reported in our laboratory for McArdle patients. All the patients changed to a lower severity class with training, such that none of them were in the highest disease severity class (3) after the intervention and, as such, they did not have fixed muscle weakness after training. Clinical improvements were retained, in all but one patient, after detraining, such that after detraining all patients were classed as

  12. Personalized Kampo Medicine Facilitated Both Cytotoxic T Lymphocyte Response and Clinical Benefits Induced by Personalized Peptide Vaccination for Advanced Esophageal Cancer

    PubMed Central

    Yutani, Shigeru; Shichijo, Shigeki; Sakamoto, Shinjiro; Naito, Masayasu; Okuda, Koji; Morita, Michi; Yamaguchi, Rin; Itoh, Kyogo

    2016-01-01

    We retrospectively evaluated if personalized Kampo medicine (PKM) could facilitate CTL responses and clinical benefits induced by personalized peptide vaccination (PPV), in which HLA-matched vaccines were selected and administered based on the preexisting host immunity, for advanced esophageal cancer (aEC) patients. Among 34 aEC patients entered in the clinical study, 23 patients received PKM and PPV without (n = 12) or with chemotherapy (n = 11), while the remaining 11 patients did not receive PKM but received PPV without (n = 6) or with chemotherapy (n = 5), respectively. Incidence of adverse events was significantly lower or higher in PKM and PPV arm (n = 23) or PPV and chemotherapy arm (n = 16) as compared to that of the counter arm (n = 11 or 18), respectively. Postvaccination PBMCs from the patients undergoing PKM and PPV showed significantly higher CTL responses as compared to the counter arm. The median progression-free survival (PFS) or median survival time (MST) of 34 patients was 2.9 or 7.6 months, respectively. The combination therapy in PPV and PKM arm, but not that in PPV and chemotherapy arm, significantly (P = 0.02) prolonged MST. These results could warrant a next step of prospective clinical study of PKM and PPV for aEC patients. PMID:27703488

  13. Additional value of F-18 FDG PET/CT for initial staging in breast cancer with clinically negative axillary nodes.

    PubMed

    Jeong, Young Jin; Kang, Do-Young; Yoon, Hyun Jin; Son, Hye Joo

    2014-05-01

    The aim of this study was to evaluate the clinical impact of the preoperative ¹⁸F-FDG PET/CT in the initial workup of breast cancer with clinically negative axillary nodes. Whether the status of the clinical axillary nodal involvement can be considered a parameter for making a decision to omit the preoperative ¹⁸F-FDG PET/CT in the situation reported herein was also determined. A total of 178 patients who had newly diagnosed breast cancer and for whom the conventional diagnostic modalities showed no sign of axillary node metastasis were retrospectively enrolled in this study. All the patients underwent preoperative ¹⁸F-FDG PET/CT. The images and histologic results that were obtained were analyzed. ¹⁸F-FDG PET/CT detected primary lesions in 156 of the 178 patients, with an overall sensitivity of 87.6 %, and false negative results were obtained for 22 patients (12.4 %). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ¹⁸F-FDG PET/CT in the detection of axillary nodes were 20.8, 86.9, 37.0, 74.8, and 69.1 %, respectively. Extra-axillary node metastasis was identified in two patients (1.1 %) who had internal mammary nodes. There was no distant metastasis, but coexisting primary tumor was detected in five patients (2.8 %). In total, the therapeutic plan was changed based on ¹⁸F-FDG PET/CT in seven (3.9 %) of the 178 patients, but considering only the cases confined to breast cancer, the change occurred in only two patients (1.1 %). ¹⁸F-FDG PET/CT almost did not affect the initial staging and treatment plan in breast cancer with clinically negative axillary node. If the axillary node is clinically negative in the preoperative workup of breast cancer, then ¹⁸F-FDG PET/CT can be omitted.

  14. A randomised clinical study to measure the anti-erosion benefits of a stannous-containing sodium fluoride dentifrice

    PubMed Central

    West, Nicola; Seong, Joon; Macdonald, Emma; He, Tao; Barker, Matthew; Hooper, Susan

    2015-01-01

    Background: To compare the enamel protection efficacy of stannous-containing sodium fluoride and sodium monofluorophosphate (MFP)/triclosan dentifrices marketed in India in an in situ erosion model with acidic challenge. Materials and Methods: This randomised and controlled, in situ, supervised, double-blind clinical trial employed a two-treatment, four-period crossover design, wherein subjects wore an appliance fitted with human enamel samples 6 h/day during each 10 day treatment period and swished twice daily with their assigned dentifrice slurry: Oral-B® Pro-Health (maximum 1,000 ppm F as sodium fluoride with stannous chloride) or Colgate® Strong Teeth with Cavity Protection (maximum 1,000 F as sodium MFP and triclosan). Subjects swished with 250 ml of orange juice over a 10 min period after each treatment and twice daily for the acidic erosive challenge. Enamel samples were measured for tooth surface loss using contact profilometry at baseline and day 10. Results: A total of 34 subjects were randomised to treatment; 32 subjects completed the final visit. Baseline profilometry measurements of the specimen surfaces were near zero within ± 0.3 μm, and no statistically significant difference (P > 0.48) on average was observed between the two test dentifrices. At day 10, the stannous-containing dentifrice demonstrated 88% less erosion (P < 0.0001) relative to the MFP/triclosan dentifrice. Estimated medians (95% confidence intervals) were 0.21 μm (0.17, 0.25) for the stannous-containing dentifrice versus 1.66 μm (1.39, 1.99) for the MFP/triclosan dentifrice. Both dentifrices were well-tolerated. Conclusions: Compared with MFP/triclosan toothpaste, a stabilised stannous-containing sodium fluoride dentifrice gave statistically significantly greater protection against tooth enamel surface loss in situ following repeated acid erosive challenge. PMID:26015669

  15. Potlining Additives

    SciTech Connect

    Rudolf Keller

    2004-08-10

    In this project, a concept to improve the performance of aluminum production cells by introducing potlining additives was examined and tested. Boron oxide was added to cathode blocks, and titanium was dissolved in the metal pool; this resulted in the formation of titanium diboride and caused the molten aluminum to wet the carbonaceous cathode surface. Such wetting reportedly leads to operational improvements and extended cell life. In addition, boron oxide suppresses cyanide formation. This final report presents and discusses the results of this project. Substantial economic benefits for the practical implementation of the technology are projected, especially for modern cells with graphitized blocks. For example, with an energy savings of about 5% and an increase in pot life from 1500 to 2500 days, a cost savings of $ 0.023 per pound of aluminum produced is projected for a 200 kA pot.

  16. Combining moderators to identify clinical profiles of patients who will, and will not, benefit from aripiprazole augmentation for treatment resistant late-life major depressive disorder.

    PubMed

    Smagula, Stephen F; Wallace, Meredith L; Anderson, Stewart J; Karp, Jordan F; Lenze, Eric J; Mulsant, Benoit H; Butters, Meryl A; Blumberger, Daniel M; Diniz, Breno S; Lotrich, Francis E; Dew, Mary Amanda; Reynolds, Charles F

    2016-10-01

    Personalizing treatment for late-life depression requires identifying and integrating information from multiple factors that influence treatment efficacy (moderators). We performed exploratory moderator analyses using data from a multi-site, randomized, placebo-controlled, double-blind trial of aripiprazole augmentation. Patients (n = 159) aged ≥60 years had major depressive disorder that failed to remit with venlafaxine monotherapy. We examined effect sizes of 39 potential moderators of aripiprazole (vs. placebo) augmentation efficacy using the outcome of percentage reduction in depressive symptom after 12 weeks. We then incorporated information from the individually relevant variables in combined moderators. A larger aripiprazole treatment effect was related to: white race, better physical function, better performance on Trail-Making, attention, immediate, and delayed memory tests, greater psychomotor agitation and suicidality symptoms, and a history of adequate antidepressant pharmacotherapy. A smaller aripiprazole treatment effect was observed in patients with: more pain and more work/activity impairment and libido symptoms. Combining information from race and Trail-Making test performance (base combined moderator (Mb*)) produced a larger effect size (Spearman effect size = 0.29 (95% confidence interval (CI): 0.15, 0.42)) than any individual moderator. Adding other individually relevant moderators in the full combined moderator (Mf*) further improved effect size (Spearman effect size = 0.39 (95% CI: 0.25, 0.52)) and identified a sub-group benefiting more from placebo plus continuation venlafaxine monotherapy than adjunctive aripiprazole. Combining moderators can help clinicians personalize depression treatment. We found the majority of our patients benefited from adjunctive aripiprazole, but a smaller subgroup that is identifiable using clinical measures appeared to benefit more from continuation venlafaxine plus placebo. PMID:27438687

  17. Impact on Life Expectancy of Withdrawing Thiopurines in Patients with Crohn’s Disease in Sustained Clinical Remission: A Lifetime Risk-Benefit Analysis

    PubMed Central

    Kirchgesner, Julien; Beaugerie, Laurent; Carrat, Fabrice; Sokol, Harry; Cosnes, Jacques; Schwarzinger, Michaël

    2016-01-01

    Objective Long-term treatment with thiopurines is associated with a decreased risk of Crohn’s disease (CD) flare but an increased risk of various cancers depending on gender, age, and presence of extensive colitis. We evaluated risks and benefits of withdrawing thiopurines in patients with CD in prolonged remission. Methods We developed a Markov model assessing risks and benefits of withdrawing thiopurines compared to continuing thiopurines in a lifetime horizon. The model was stratified by age (35 and 65 years old at thiopurine withdrawal), gender and presence of extensive colitis. Parameter estimates were taken from French cohorts and hospital databases, cancer and death national registries and published literature. Life expectancy, rates of relapse, serious adverse events, and causes-of-death were evaluated. Results In patients without extensive colitis, continuing thiopurines increased life expectancy up to 0.03 years for 35 year-old men and women but decreased life expectancy down to 0.07 years for 65 year-old men and women. Withdrawal strategy became the preferred strategy at 40.6 years for men, and 45.7 years for women without extensive colitis. In patients with extensive colitis, continuation strategy was the preferred strategy regardless of age. Risk-benefit analysis was not modified by duration of CD activity. Conclusions Factors determining life expectancy associated with withdrawal or continuation of thiopurines in patients with CD and in sustained clinical remission vary substantially according to gender, age and presence of extensive colitis. Individual decisions to continue or withdraw thiopurines in patients with CD in sustained remission should take into account these parameters. PMID:27271176

  18. Clinical Evaluation of Functional Vision of +1.5 Diopters near Addition, Aspheric, Rotational Asymmetric Multifocal Intraocular Lens

    PubMed Central

    Khoramnia, Rahmin; Attia, Mary Safwat; Koss, Michael Janusz; Linz, Katharina; Auffarth, Gerd Uwe

    2016-01-01

    Purpose To evaluate postoperative outcomes and visual performance in intermediate distance after implantation of a +1.5 diopters (D) addition, aspheric, rotational asymmetric multifocal intraocular lens (MIOL). Methods Patients underwent bilateral cataract surgery with implantation of an aspheric, asymmetric MIOL with +1.5 D near addition. A complete ophthalmological examination was performed preoperatively and 3 months postoperatively. The main outcome measures were monocular and binocular uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UNVA) and distance corrected keratometry, and manifest refraction. The Salzburg Reading Desk was used to analyze unilateral and bilateral functional vision with uncorrected and corrected reading acuity, reading distance, reading speed, and the smallest log-scaled print size that could be read effectively at near and intermediate distances. Results The study comprised 60 eyes of 30 patients (mean age, 68.30 ± 9.26 years; range, 34 to 80 years). There was significant improvement in UDVA and CDVA. Mean UIVA was 0.01 ± 0.09 logarithm of the minimum angle of resolution (logMAR) and mean DCIVA was -0.02 ± 0.11 logMAR. In Salzburg Reading Desk analysis for UIVA, the mean subjective intermediate distance was 67.58 ± 8.59 cm with mean UIVA of -0.02 ± 0.09 logMAR and mean word count of 96.38 ± 28.32 words/min. Conclusions The new aspheric, asymmetric, +1.5 D near addition MIOL offers good results for distance visual function in combination with good performance for intermediate distances and functional results for near distance. PMID:27729759

  19. Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal

    PubMed Central

    Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M. Juliana; Hural, John

    2014-01-01

    assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%–130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. PMID:24709391

  20. KDR Amplification Is Associated with VEGF-Induced Activation of the mTOR and Invasion Pathways but does not Predict Clinical Benefit to the VEGFR TKI Vandetanib

    PubMed Central

    Nilsson, Monique B.; Giri, Uma; Gudikote, Jayanthi; Tang, Ximing; Lu, Wei; Tran, Hai; Fan, Youhong; Koo, Andrew; Diao, Lixia; Tong, Pan; Wang, Jing; Herbst, Roy; Johnson, Bruce E.; Ryan, Andy; Webster, Alan; Rowe, Philip; Wistuba, Ignacio I.; Heymach, John V.

    2016-01-01

    Purpose VEGF pathway inhibitors have been investigated as therapeutic agents in the treatment of non–small cell lung cancer (NSCLC) because of its central role in angiogenesis. These agents have improved survival in patients with advanced NSCLC, but the effects have been modest. Although VEGFR2/KDR is typically localized to the vasculature, amplification of KDR has reported to occur in 9% to 30% of the DNA from different lung cancers. We investigated the signaling pathways activated downstream of KDR and whether KDR amplification is associated with benefit in patients with NSCLC treated with the VEGFR inhibitor vandetanib. Methods NSCLC cell lines with or without KDR amplification were studied for the effects of VEGFR tyrosine kinase inhibitors (TKI) on cell viability and migration. Archival tumor samples collected from patients with platinum-refractory NSCLC in the phase III ZODIAC study of vandetanib plus docetaxel or placebo plus docetaxel (N = 294) were screened for KDR amplification by FISH. Results KDR amplification was associated with VEGF-induced activation of mTOR, p38, and invasiveness in NSCLC cell lines. However, VEGFR TKIs did not inhibit proliferation of NSCLC cell lines with KDR amplification. VEGFR inhibition decreased cell motility as well as expression of HIF1α in KDR-amplified NSCLC cells. In the ZODIAC study, KDR amplification was observed in 15% of patients and was not associated with improved progression-free survival, overall survival, or objective response rate for the vandetanib arm. Conclusions Preclinical studies suggest KDR activates invasion but not survival pathways in KDR-amplified NSCLC models. Patients with NSCLC whose tumor had KDR amplification were not associated with clinical benefit for vandetanib in combination with docetaxel. PMID:26578684

  1. No effect of additional screw fixation of a cementless, all-polyethylene press-fit socket on migration, wear, and clinical outcome.

    PubMed

    Minten, Michiel J M; Heesterbeek, Petra J C; Spruit, Maarten

    2016-08-01

    Background and purpose - Additional screw fixation of the all-polyethylene press-fit RM cup (Mathys) has no additional value for migration, in the first 2 years after surgery. However, the medium-term and long-term effects of screw fixation remain unclear. We therefore evaluated the influence of screw fixation on migration, wear, and clinical outcome at 6.5 years using radiostereometric analysis (RSA). Patients and methods - This study involved prolonged follow-up from a previous randomized controlled trial (RCT). We analyzed RSA radiographs taken at baseline and at 1-, 2-, and 6.5-year follow-up. Cup migration and wear were assessed using model-based RSA software. Wear was calculated as translation of the femoral head model in relation to the cup model. Total translation, rotation, and wear were calculated mathematically from results of the orthogonal components. Results - 27 patients (15 with screw fixation and 12 without) were available for follow-up at 6.5 (5.6-7.2) years. Total translation (0.50 mm vs. 0.56 mm) and rotation (1.01 degrees vs. 1.33 degrees) of the cup was low, and was not significantly different between the 2 groups. Wear increased over time, and was similar between the 2 groups (0.58 mm vs. 0.53 mm). Wear rate (0.08 mm/year vs. 0.09 mm/year) and clinical outcomes were also similar. Interpretation - Our results indicate that additional screw fixation of all-polyethylene press-fit RM cups has no additional value regarding medium-term migration and clinical outcome. The wear rate was low in both groups. PMID:27299418

  2. To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial

    PubMed Central

    2011-01-01

    Background Recently, there has been mounting interest in scaling-up vector control against malaria in Africa. It needs to be determined if indoor residual spraying (IRS with DDT) will provide significant marginal protection against malaria over current best practice of long-lasting insecticidal nets (LLINs) and prompt treatment in a controlled trial, given that DDT is currently the most persistent insecticide for IRS. Methods A 2 armed cluster-randomised controlled trial will be conducted to assess whether DDT IRS and LLINs combined provide better protection against clinical malaria in children than LLINs alone in rural Gambia. Each cluster will be a village, or a group of small adjacent villages; all clusters will receive LLINs and half will receive IRS in addition. Study children, aged 6 months to 13 years, will be enrolled from all clusters and followed for clinical malaria using passive case detection to estimate malaria incidence for 2 malaria transmission seasons in 2010 and 2011. This will be the primary endpoint. Exposure to malaria parasites will be assessed using light and exit traps followed by detection of Anopheles gambiae species and sporozoite infection. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection and the prevalence of anaemia. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN01738840 - Spraying And Nets Towards malaria Elimination (SANTE) PMID:21663656

  3. A clinical prognostic scoring system for resectable gastric cancer to predict survival and benefit from paclitaxel- or oxaliplatin-based adjuvant chemotherapy

    PubMed Central

    Qian, Jing; Qian, Yingying; Wang, Jian; Gu, Bing; Pei, Dong; He, Shaohua; Zhu, Fang; Røe, Oluf Dimitri; Xu, Jin; Liu, Lianke; Gu, Yanhong; Guo, Renhua; Yin, Yongmei; Shu, Yongqian; Chen, Xiaofeng

    2016-01-01

    Background Gastrectomy with D2 lymphadenectomy is a standard procedure of curative resection for gastric cancer (GC). The aim of this study was to develop a simple and reliable prognostic scoring system for GC treated with D2 gastrectomy combined with adjuvant chemotherapy. Methods A prognostic scoring system was established based on clinical and laboratory data from 579 patients with localized GC without distant metastasis treated with D2 gastrectomy and adjuvant chemotherapy. Results From the multivariate model for overall survival (OS), five factors were selected for the scoring system: ≥50% metastatic lymph node rate, positive lymphovascular invasion, pathologic TNM Stage II or III, ≥5 ng/mL preoperative carcinoembryonic antigen level, and <110 g/L preoperative hemoglobin. Two models were derived using different methods. Model A identified low- and high-risk patients for OS (P<0.001), while Model B differentiated low-, intermediate-, and high-risk patients for OS (P<0.001). Stage III patients in the low-risk group had higher survival probabilities than Stage II patients. Both Model A (area under the curve [AUC]: 0.74, 95% confidence interval [CI]: 0.69–0.78) and Model B (AUC: 0.79, 95% CI: 0.72–0.83) were better predictors compared with the pathologic TNM classification (AUC: 0.62, 95% CI: 0.59–0.71, P<0.001). Adjuvant paclitaxel- or oxaliplatin-based or triple chemotherapy showed significantly better outcomes in patients classified as high risk, but not in those with low and intermediate risk. Conclusion A clinical three-tier prognostic risk scoring system was established to predict OS of GC treated with D2 gastrectomy and adjuvant chemotherapy. The potential advantage of this scoring system is that it can identify high-risk patients in Stage II or III who may benefit from paclitaxel- or oxaliplatin-based regimens. Prospective studies are needed to confirm these results before they are applied clinically. PMID:26966350

  4. A Study to Determine if Addition of Palatal Petechiae to Centor Criteria Adds More Significance to Clinical Diagnosis of Acute Strep Pharyngitis in Children.

    PubMed

    Nibhanipudi, Kumara V

    2016-01-01

    Objective. A study to determine if addition of palatal petechiae to Centor criteria adds more value for clinical diagnosis of acute strep pharyngitis in children. Hypothesis. In children, Centor Criteria does not cover all the symptoms and signs of acute strep pharyngitis. We hypothesize that addition of palatal petechiae to Centor Criteria will increase the possibility of clinical diagnosis of group A streptococcal pharyngitis in children. Methods. One hundred patients with a complaint of sore throat were enrolled in the study. All the patients were examined clinically using the Centor Criteria. They were also examined for other signs and symptoms like petechial lesions over the palate, abdominal pain, and skin rash. All the patients were given rapid strep tests, and throat cultures were sent. No antibiotics were given until culture results were obtained. Results. The sample size was 100 patients. All 100 had fever, sore throat, and erythema of tonsils. Twenty of the 100 patients had tonsillar exudates, 85/100 had tender anterior cervical lymph nodes, and 86/100 had no cough. In total, 9 out of the 100 patients had positive throat cultures. We observed that petechiae over the palate, a very significant sign, is not included in the Centor Criteria. Palatal petechiae were present in 8 out of the 100 patients. Six out of these 8 with palatal petechiae had positive throat culture for strep (75%). Only 7 out of 20 with exudates had positive strep culture. Sixteen out of the 100 patients had rapid strep test positive. Those 84/100 who had negative rapid strep also had negative throat culture. Statistics. We used Fisher's exact test, comparing throat culture positive and negative versus presence of exudates and palatal hemorrhages with positive and negative throat cultures and the resultant P value <.0001. Conclusion. Our study concludes that addition of petechiae over the palate to Centor Criteria will increase the possibility of diagnosing acute group A streptococcal

  5. A Study to Determine if Addition of Palatal Petechiae to Centor Criteria Adds More Significance to Clinical Diagnosis of Acute Strep Pharyngitis in Children

    PubMed Central

    Nibhanipudi, Kumara V.

    2016-01-01

    Objective. A study to determine if addition of palatal petechiae to Centor criteria adds more value for clinical diagnosis of acute strep pharyngitis in children. Hypothesis. In children, Centor Criteria does not cover all the symptoms and signs of acute strep pharyngitis. We hypothesize that addition of palatal petechiae to Centor Criteria will increase the possibility of clinical diagnosis of group A streptococcal pharyngitis in children. Methods. One hundred patients with a complaint of sore throat were enrolled in the study. All the patients were examined clinically using the Centor Criteria. They were also examined for other signs and symptoms like petechial lesions over the palate, abdominal pain, and skin rash. All the patients were given rapid strep tests, and throat cultures were sent. No antibiotics were given until culture results were obtained. Results. The sample size was 100 patients. All 100 had fever, sore throat, and erythema of tonsils. Twenty of the 100 patients had tonsillar exudates, 85/100 had tender anterior cervical lymph nodes, and 86/100 had no cough. In total, 9 out of the 100 patients had positive throat cultures. We observed that petechiae over the palate, a very significant sign, is not included in the Centor Criteria. Palatal petechiae were present in 8 out of the 100 patients. Six out of these 8 with palatal petechiae had positive throat culture for strep (75%). Only 7 out of 20 with exudates had positive strep culture. Sixteen out of the 100 patients had rapid strep test positive. Those 84/100 who had negative rapid strep also had negative throat culture. Statistics. We used Fisher’s exact test, comparing throat culture positive and negative versus presence of exudates and palatal hemorrhages with positive and negative throat cultures and the resultant P value <.0001. Conclusion. Our study concludes that addition of petechiae over the palate to Centor Criteria will increase the possibility of diagnosing acute group A streptococcal

  6. The addition of cervical unilateral posterior-anterior mobilisation in the treatment of patients with shoulder impingement syndrome: a randomised clinical trial.

    PubMed

    Cook, Chad; Learman, Ken; Houghton, Steve; Showalter, Christopher; O'Halloran, Bryan

    2014-02-01

    Shoulder impingement syndrome (SIS) is a complex, multi-factorial problem that is treated with a variety of different conservative options. One conservative option that has shown effectiveness is manual therapy to the thoracic spine. Another option, manual therapy to the cervical spine, has been studied only once with good results, evaluating short-term outcomes, in a small sample size. The purpose of this study was to investigate the benefit of neck manual therapy for patients with SIS. The study was a randomised, single blinded, clinical trial where both groups received pragmatic, evidence-based treatment to the shoulder and one group received neck manual therapy. Subjects with neck pain were excluded from the study. Comparative pain, disability, rate of recovery and patient acceptable symptom state (PASS) measures were analyzed on the 68 subjects seen over an average of 56.1 days (standard deviation (SD)=55.4). Eighty-six percent of the sample reported an acceptable change on the PASS at discharge. There were no between-groups differences in those who did or did not receive neck manual therapy; however, both groups demonstrated significant within-groups improvements. On average both groups improved 59.7% (SD=25.1) for pain and 53.5% (SD=40.2) for the Quick Disabilities of the Shoulder and Hand Questionnaire (QuickDASH) from baseline. This study found no value when neck manual therapy was added to the treatment of SIS. Reasons may include the lack of therapeutic dosage provided for the manual therapy approach or the lack of benefit to treating the neck in subjects with SIS who do not have concomitant neck problems.

  7. Multiple Benefits.

    ERIC Educational Resources Information Center

    Kreider, Beth

    1997-01-01

    Discusses the benefits of dome architecture for a community's middle- and high-school multi-purpose facility. The dome construction is revealed as being cost effective in construction and in maintenance and energy costs. (GR)

  8. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds.

    PubMed

    Jørgensen, Bo; Karlsmark, Tonny; Vogensen, Hanne; Haase, Lone; Lundquist, Rasmus

    2011-12-01

    This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated weekly with Leucopatch, prepared at the point of care from a donation of the patients' blood, for 6 weeks, or until healing was complete. The wounds had been present for 2 to 108 months (median 24 months) and ranged in size from 0.4 to 15.7 cm(2) (median 2.3 cm(2)) and had not responded to previous treatments. Of the 13 wounds (12 patients) included in the per-protocol efficacy analysis, 4 healed completely (31%). Mean wound area decreased significantly by 65% (95% confidence interval = 45.6% to 83.8%) resulting in a median wound size of 0.9 cm(2) (range = 0-9.6cm(2)). There were no serious adverse events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds.

  9. Additional hemodynamic measurements with an esophageal Doppler monitor: a preliminary report of compliance, force, kinetic energy, and afterload in the clinical setting.

    PubMed

    Atlas, Glen; Brealey, David; Dhar, Sunil; Dikta, Gerhard; Singer, Meryvn

    2012-12-01

    The esophageal Doppler monitor (EDM) is a minimally-invasive hemodynamic device which evaluates both cardiac output (CO), and fluid status, by estimating stroke volume (SV) and calculating heart rate (HR). The measurement of these parameters is based upon a continuous and accurate approximation of distal thoracic aortic blood flow. Furthermore, the peak velocity (PV) and mean acceleration (MA), of aortic blood flow at this anatomic location, are also determined by the EDM. The purpose of this preliminary report is to examine additional clinical hemodynamic calculations of: compliance (C), kinetic energy (KE), force (F), and afterload (TSVR(i)). These data were derived using both velocity-based measurements, provided by the EDM, as well as other contemporaneous physiologic parameters. Data were obtained from anesthetized patients undergoing surgery or who were in a critical care unit. A graphical inspection of these measurements is presented and discussed with respect to each patient's clinical situation. When normalized to each of their initial values, F and KE both consistently demonstrated more discriminative power than either PV or MA. The EDM offers additional applications for hemodynamic monitoring. Further research regarding the accuracy, utility, and limitations of these parameters is therefore indicated.

  10. A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers.

    PubMed

    Buzzi, Marcelo; de Freitas, Franciele; Winter, Marcos

    2016-03-01

    Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs. Patients diagnosed with a stable neuropathic ulcer of >3 months' duration; ranging in size from 0.5-40 cm(2); without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18-90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients' blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients' ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) - 17 women, average age 62 years (range 44-82 years), average glycemic level 153 mg

  11. A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers.

    PubMed

    Buzzi, Marcelo; de Freitas, Franciele; Winter, Marcos

    2016-03-01

    Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs. Patients diagnosed with a stable neuropathic ulcer of >3 months' duration; ranging in size from 0.5-40 cm(2); without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18-90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients' blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients' ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) - 17 women, average age 62 years (range 44-82 years), average glycemic level 153 mg

  12. The Clinical Impact of Continuing to Prescribe Antiretroviral Therapy in Patients with Advanced AIDS Who Manifest No Virologic or Immunologic Benefit

    PubMed Central

    Wohl, David A.; Kendall, Michelle A.; Feinberg, Judith; Alston-Smith, Beverly; Owens, Susan; Chafey, Suzette; Marco, Michael; Maxwell, Sharon; Benson, Constance; Keiser, Philip; van der Horst, Charles; Jacobson, Mark A.

    2013-01-01

    Introduction Despite the efficacy and tolerability of modern antiretroviral therapy (ART), many patients with advanced AIDS prescribed these regimens do not achieve viral suppression or immune reconstitution as a result of poor adherence, drug resistance, or both. The clinical outcomes of continued ART prescription for such patients have not been well characterized. Methods We examined the causes and predictors of all-cause mortality, AIDS-defining conditions, and serious non-AIDS-defining events among a cohort of participants in a clinical trial of pre-emptive therapy for CMV disease. We focused on participants who, despite ART had failed to achieve virologic suppression and substantive immune reconstitution. Results 233 ART-receiving participants entered with a median baseline CD4+ T cell count of 30/mm3 and plasma HIV RNA of 5 log10 copies/mL. During a median 96 weeks of follow-up, 24.0% died (a mortality rate of 10.7/100 patient-years); 27.5% reported a new AIDS-defining condition, and 22.3% a new serious non-AIDS event. Of the deaths, 42.8% were due to an AIDS-defining condition, 44.6% were due to a non-AIDS-defining condition, and 12.5% were of unknown etiology. Decreased risk of mortality was associated with baseline CD4+ T cell count ≥25/mm3 and lower baseline HIV RNA. Conclusions Among patients with advanced AIDS prescribed modern ART who achieve neither virologic suppression nor immune reconstitution, crude mortality percentages appear to be lower than reported in cohorts of patients studied a decade earlier. Also, in contrast to the era before modern ART became available, nearly half of the deaths in our modern-era study were caused by serious non-AIDS-defining events. Even among the most advanced AIDS patients who were not obtaining apparent immunologic and virologic benefit from ART, continued prescription of these medications appears to alter the natural history of AIDS—improving survival and shifting the causes of death from AIDS- to non

  13. Clinical significance of the administration of cytarabine or thiotepa in addition to total body irradiation and cyclophosphamide for allogeneic hematopoietic cell transplantation in patients with acute leukemia.

    PubMed

    Tachibana, Takayoshi; Tanaka, Masatsugu; Hagihara, Maki; Kawasaki, Rika; Yamazaki, Etsuko; Koharazawa, Hideyuki; Taguchi, Jun; Tomita, Naoto; Fujimaki, Katsumichi; Sakai, Rika; Fujita, Hiroyuki; Fujisawa, Shin; Maruta, Atsuo; Ishigatsubo, Yoshiaki; Kanamori, Heiwa

    2015-10-01

    A multicenter retrospective study was performed to determine the significance of adding cytarabine (CA) or thiotepa (TT) in the context of total body irradiation (TBI) and cyclophosphamide (CY). A total of 322 patients who underwent allogeneic hematopoietic cell transplantation (HCT) were distributed to the following three groups: TBI/CY (n = 75), TBI/CY/CA (n = 77), and TBI/CY/TT (n = 170). In the TBI/CY/TT group, 164 of patients (96 %) received HCT during the previous year (2000-2005). Multivariate analysis revealed that the TBI/CY/TT group demonstrated a trend of poorer survival rate than the TBI/CY group, [hazard ratio (HR) = 1.49, 95 % confidence interval (CI) 0.99-2.24, P = 0.055] with a higher non-relapse mortality (NRM) (HR = 2.34, 95 % CI 1.35-4.06, P = 0.002) rates, while TBI/CY/CA group demonstrated similar outcomes. Even in the subgroup analyses of disease type or disease risk, the outcomes with intensified conditioning regimens were not superior to those with TBI/CY. In conclusion, although the significant bias has to be carefully considered, the clinical benefit of adding CA or TT to the TBI/CY regimen was not demonstrated.

  14. Benefits of antihypertensive medications for anthracycline- and trastuzumab-induced cardiotoxicity in patients with breast cancer: Insights from recent clinical trials

    PubMed Central

    Rygiel, Katarzyna

    2016-01-01

    Advances in oncologic therapies have allowed many patients with breast cancer to achieve better outcomes and longer survival. However, this progress has been tempered by cardiotoxicity, associated with anticancer therapies, ranging from subclinical abnormalities to irreversible life-threatening complications, such as congestive heart failure or cardiomyopathy. In particular, exposure to chemotherapy (CHT), including anthracyclines and trastuzumab, can lead to cardiac dysfunction with short- or long-term consequences, among patients with breast cancer. The aim of this study is to highlight the potential role of commonly used cardiac medications in the prevention of anthracycline- and trastuzumab-mediated cardiotoxicity, in women with breast cancer, based on evidence from recent clinical trials. This overview is focused on the use of antihypertensive medications, such as angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, outlining their cardioprotective effects in this patient population. In addition, the importance of biomarkers and modern imaging tests, as potential tools for detection and monitoring of cardiac dysfunction, induced by CHT, as well as some practical preventive and therapeutic strategies for cardio-oncology treatment teams, involved in the management of a growing number of women with breast cancer have been outlined. The content of this overview is based on a literature search of PubMed, within the last 5 years, mostly in relevance to the human epidermal growth factor receptor 2-positive patients with breast cancer, treated with anthracycline or trastuzumab therapy (in addition to surgery and/or radiation therapy [RT] regimen). PMID:27721532

  15. Medicaid Benefits

    MedlinePlus

    ... Topic Eligibility Benefits Cost Sharing Waivers Long Term Services and Supports Delivery Systems Quality of Care Data and Systems Enrollment Strategies Access to Care Program Integrity Financing and ... type, amount, duration, and scope of services within broad federal guidelines. States are required to ...

  16. Benefits of switching from latanoprost to preservative-free tafluprost eye drops: a meta-analysis of two Phase IIIb clinical trials

    PubMed Central

    Uusitalo, Hannu; Egorov, Evgeniy; Kaarniranta, Kai; Astakhov, Yuri; Ropo, Auli

    2016-01-01

    Introduction Glaucoma patients frequently exhibit ocular surface side effects during treatment with prostaglandin eye drops. The present work investigated whether glaucoma patients suffering from signs and symptoms of ocular surface disease while using preserved latanoprost eye drops benefited from switching to preservative-free tafluprost eye drops. Patients and methods The analysis was based on 339 glaucoma patients enrolled in two Phase IIIb trials. The patients were required to have two symptoms, or one sign and one symptom of ocular surface disease at baseline, and at least 6 months preceding treatment with latanoprost eye drops preserved with benzalkonium chloride. All eligible patients were switched from latanoprost to preservative-free tafluprost for a total of 12 weeks. Ocular symptoms and ocular signs were evaluated at baseline and at 2 weeks, 6 weeks, and 12 weeks after commencing treatment with tafluprost. Intraocular pressure (IOP), drop discomfort, and treatment preference were evaluated to investigate the clinical efficacy and patient-related outcomes. Results After 12 weeks of treatment with preservative-free tafluprost, the incidences of irritation/burning/stinging, foreign body sensation, tearing, itching, and dry eye sensation had diminished to one-third of those reported for preserved latanoprost at baseline. The incidences of blepharitis and corneal/conjunctival fluorescein staining had in turn decreased to one-half of those reported for preserved latanoprost. Severity of conjunctival hyperemia was halved during treatment with preservative-free tafluprost, and there was significant improvement in tear break-up time and tear production. A further reduction in IOP (~1 mmHg) was seen with preservative-free tafluprost compared with preserved latanoprost. Drop discomfort was alleviated during preservative-free tafluprost treatment, and an outstanding majority of patients (72%) preferred preservative-free tafluprost over preserved latanoprost

  17. SU-E-T-361: Clinical Benefit of Automatic Beam Gating Mixed with Breath Hold in Radiation Therapy of Left Breast

    SciTech Connect

    Wu, J; Hill, G; Spiegel, J; Ye, J; Mehta, V

    2014-06-01

    Purpose: To investigate the clinical and dosimetric benefits of automatic gating of left breast mixed with breath-hold technique. Methods: Two Active Breathing Control systems, ABC2.0 and ABC3.0, were used during simulation and treatment delivery. The two systems are different such that ABC2.0 is a breath-hold system without beam control capability, while ABC3.0 has capability in both breath-hold and beam gating. At simulation, each patient was scanned twice: one with free breathing (FB) and one with breath hold through ABC. Treatment plan was generated on the CT with ABC. The same plan was also recalculated on the CT with FB. These two plans were compared to assess plan quality. For treatments with ABC2.0, beams with MU > 55 were manually split into multiple subfields. All subfields were identical and shared the total MU. For treatment with ABC3.0, beam splitting was unnecessary. Instead, treatment was delivered in gating mode mixed with breath-hold technique. Treatment delivery efficiency using the two systems was compared. Results: The prescribed dose was 50.4Gy at 1.8Gy/fraction. The maximum heart dose averaged over 10 patients was 46.0±2.5Gy and 24.5±12.2Gy for treatments with FB and with ABC respectively. The corresponding heart V10 was 13.2±3.6% and 1.0±1.6% respectively. The averaged MUs were 99.8±7.5 for LMT, 99.2±9.4 for LLT. For treatment with ABC2.0, normally the original beam was split into 2 subfields. The averaged total time to delivery all beams was 4.3±0.4min for treatments with ABC2.0 and 3.3±0.6min for treatments with ABC3.0 in gating mode. Conclusion: Treatment with ABC tremendously reduced heart dose. Compared to treatments with ABC2.0, gating with ABC3.0 reduced the total treatment time by 23%. Use of ABC3.0 improved the delivery efficiency, and eliminated the possibility of mistreatments. The latter may happen with ABC2.0 where beam is not terminated when breath signal falls outside of the treatment window.

  18. The impact of extracellular matrix on the chemoresistance of solid tumors--experimental and clinical results of hyaluronidase as additive to cytostatic chemotherapy.

    PubMed

    Baumgartner, G; Gomar-Höss, C; Sakr, L; Ulsperger, E; Wogritsch, C

    1998-09-11

    Chemoresistance is of outstanding importance for the limited results of chemotherapy in solid tumors. Chemoresistance of multicellular tumor tissues is more pronounced than that of single cells in vivo and in vitro. The enzyme hyaluronidase is able to loosen the cell-cell contact and the interstitial connective tissue and as such, in a number of preclinical and clinical trials, was shown to enhance the efficacy of cytostatic agents. Although proven to be very effective as additive to local chemotherapy, the systemic efficacy is not documented as well. We present a randomized trial done in high-grade astrocytomas with combined chemotherapy and radiation therapy with and without hyaluronidase. After very promising pilot results with systemic hyaluronidase in various tumor entities and also astrocytomas, this randomized study failed to show synergy to chemotherapy and radiation therapy in high-grade astrocytomas concerning survival. The promising preclinical data and the rather well documented activity in therapeutic use as additive to local chemotherapy seem to be an adequate motive to further elucidate the complex manner in which hyaluronidase is active in the interstitial tumor matrix and to obtain more information concerning the optimal route of application, the optimal dosage and the spectrum of tumor entities where it is synergistic with cytostatic chemotherapy and perhaps even radiation therapy.

  19. Capturing patient benefits of treatment.

    PubMed

    Carr, Alan; Wolfaardt, John; Garrett, Neal

    2011-01-01

    Findings from the Academy of Osseointegration State of the Science on Implant Dentistry Conference clearly demonstrate that data are lacking regarding both quality of design and adequate outcome measures (standardization, validity, and relevance to patient) to support an evidence-based systematic evaluation of implant efficacy. Despite the dearth of controlled trials and the variability in defining implant survival/success, the preponderance of evidence is viewed as lending support for consideration of dental implant therapy as a safe and predictable alternative to conventional restorations for many applications. However, this minimal conclusion undermines the best intentions of the dental profession, which is striving to substantiate to the patient, third-party providers, and the government the relative benefits and risks of various prosthetic treatment alternatives. The conclusions of multiple consensus conferences have repeatedly stressed that additional research with good strength of evidence following a broad spectrum of outcomes is vital to extend the breadth of conclusions regarding dental implant treatment efficacy. However, without a set of consensus-based core outcome measures addressing pertinent clinical and patient-centered factors, future expensive, time-consuming, and technically complex clinical studies may suffer the same critical flaws seen in the current body of research. It may be possible and useful to establish a core set of well-defined, discriminatory, and feasible outcome measures for common utilization and a hierarchy of additional recommended outcome measures for specific benefit categories. Such a standardized group of outcome measures would be likely to significantly enhance the potential for future research. In addition, with the formation of consensus guidelines, there would be an opportunity for scientific journals to promote the quality of implant dentistry research by suggesting the inclusion of these core outcome measures in

  20. Benefits of infant massage.

    PubMed

    Day, Jane

    2014-05-01

    After spending three months as a clinical midwifery tutor at a remote hospital in Zambia, where I helped to train student midwives and other students, my interest in infant massage was ignited, having witnessed the benefits of massage to both mother and baby. Once back in the UK, I trained and qualified as a massage instructor with an international infant massage training organisation, which has led me to work extensively with parents and babies, offering one-to-one and group courses. It has been a privilege to be able to teach parents the valuable skill of infant massage, and consequently pass on the benefits both physiological and psychosocial. PMID:24873112

  1. Topics in Microeconometrics: Estimation of a Dynamic Model of Occupational Transitions, Wage and Non-Wage Benefits Cross Validation Bandwidth Selection for Derivatives of Various Dimensional Densities Testing the Additive Separability of the Teacher Value Added Effect Semiparametrically

    ERIC Educational Resources Information Center

    Baird, Matthew David

    2012-01-01

    I study three separate questions in this dissertation. In Chapter 1, I develop and estimate a structural dynamic model of occupation and job choice to test hypotheses of the importance of wages and non-wages and learning in occupational transitions, and find that wages are approximately 3 times as important as non-wage benefits in decisions and…

  2. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial

    PubMed Central

    Cella, D.; Ivanescu, C.; Holmstrom, S.; Bui, C. N.; Spalding, J.; Fizazi, K.

    2015-01-01

    Background To present longitudinal changes in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores during 25-week treatment with enzalutamide or placebo in men with progressive metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial. Patients and methods Patients were randomly assigned to enzalutamide 160 mg/day or placebo. FACT-P was completed before randomization, at weeks 13, 17, 21, and 25, and every 12 weeks thereafter while on study treatment. Longitudinal changes in FACT-P scores from baseline to 25 weeks were analyzed using a mixed effects model for repeated measures (MMRM), with a pattern mixture model (PMM) applied as secondary analysis to address non-ignorable missing data. Cumulative distribution function (CDF) plots were generated and different methodological approaches and models for handling missing data were applied. Due to the exploratory nature of the analyses, adjustments for multiple comparisons were not made. AFFIRM is registered with ClinicalTrials.gov, number NCT00974311. Results The intention-to-treat FACT-P population included 938 patients (enzalutamide, n = 674; placebo n = 264) with evaluable FACT-P assessments at baseline and ≥1 post-baseline assessment. After 25 weeks, the mean FACT-P total score decreased by 1.52 points with enzalutamide compared with 13.73 points with placebo (P < 0.001). In addition, significant treatment differences at week 25 favoring enzalutamide were evident for all FACT-P subscales and indices, whether analyzed by MMRM or PMM. CDF plots revealed differences favoring enzalutamide compared with placebo across the full range of possible response levels for FACT-P total and all disease- and symptom-specific subscales/indices. Conclusion In men with progressive mCRPC after docetaxel-based chemotherapy, enzalutamide is superior to placebo in health-related quality-of-life outcomes, regardless of analysis model or threshold selected for meaningful response. Clinical

  3. Technology Benefits

    NASA Technical Reports Server (NTRS)

    Haller, William

    2001-01-01

    An assessment was recently performed by NASA s Inter-Center Systems Analysis Team to quantify the potential emission reduction benefits from technologies being developed under UEET. The CO2 and LTO NO, reductions were estimated for 4 vehicles: a 50-passenger regional jet, a twin-engine, long-range subsonic transport, a high-speed (Mach 2.4) civil transport and a supersonic (Mach 2) business jet. The results of the assessment confirm that the current portfolio of technologies within the UEET program provides an opportunity for substantial reductions in CO2 and NO, emissions.

  4. Meal replacements and fibre supplement as a strategy for weight loss. Proprietary PGX® meal replacement and PGX® fibre supplement in addition to a calorie-restricted diet to achieve weight loss in a clinical setting.

    PubMed

    Reichert, Ronald G; Reimer, Raylene A; Kacinik, Veronica; Pal, Sebely; Gahler, Roland J; Wood, Simon

    2013-01-01

    Meal replacements and viscous soluble fibre represent safe and sustainable aids for weight loss. Our purpose was to determine if PGX® meal replacements and PGX(®) fibre complex in combination with a calorie-restricted diet would aid in weight loss in a clinical setting. Fifty-two overweight and obese participants (49 women, 3 men; average age 47.1 years) with a mean body mass index (BMI) of 33.8 ± 6.4 kg/m(2) consumed 57 g of proprietary PGX® meal replacement product at breakfast and another 57 g at lunch for 12 weeks. In addition to the meal replacements, they were also asked to consume 5 g/day of PGX® fibre in the form of granules, powder or capsules together with 250 mlwater. A registered dietician recommended low-fat, low-glycaemic-index foods for snacks and the dinner menus such that each volunteer was consuming a total of 1200 kcal/day. All participants (n = 52) lost a significant amount of weight from baseline (-4.69 ± 3.73 kg), which was further reflected in the reductions in their waist (-7.11 ± 6.35 cm) and hip circumference (-5.59 ± 3.58 cm) over the 12-week study (p < 0.0001). BMI scores (n = 51) were reduced by 1.6 ± 1.4 kg/m(2). The use of PGX® meal replacements and PGX(®) fibre along with a controlled dietary caloric intake is of benefit for short-term weight loss.

  5. Meal replacements and fibre supplement as a strategy for weight loss. Proprietary PGX® meal replacement and PGX® fibre supplement in addition to a calorie-restricted diet to achieve weight loss in a clinical setting.

    PubMed

    Reichert, Ronald G; Reimer, Raylene A; Kacinik, Veronica; Pal, Sebely; Gahler, Roland J; Wood, Simon

    2013-01-01

    Meal replacements and viscous soluble fibre represent safe and sustainable aids for weight loss. Our purpose was to determine if PGX® meal replacements and PGX(®) fibre complex in combination with a calorie-restricted diet would aid in weight loss in a clinical setting. Fifty-two overweight and obese participants (49 women, 3 men; average age 47.1 years) with a mean body mass index (BMI) of 33.8 ± 6.4 kg/m(2) consumed 57 g of proprietary PGX® meal replacement product at breakfast and another 57 g at lunch for 12 weeks. In addition to the meal replacements, they were also asked to consume 5 g/day of PGX® fibre in the form of granules, powder or capsules together with 250 mlwater. A registered dietician recommended low-fat, low-glycaemic-index foods for snacks and the dinner menus such that each volunteer was consuming a total of 1200 kcal/day. All participants (n = 52) lost a significant amount of weight from baseline (-4.69 ± 3.73 kg), which was further reflected in the reductions in their waist (-7.11 ± 6.35 cm) and hip circumference (-5.59 ± 3.58 cm) over the 12-week study (p < 0.0001). BMI scores (n = 51) were reduced by 1.6 ± 1.4 kg/m(2). The use of PGX® meal replacements and PGX(®) fibre along with a controlled dietary caloric intake is of benefit for short-term weight loss. PMID:24568282

  6. The added value of using mutational profiling in addition to cytology in diagnosing aggressive pancreaticobiliary disease: review of clinical cases at a single center

    PubMed Central

    2014-01-01

    Background This study aimed to better understand the supporting role that mutational profiling (MP) of DNA from microdissected cytology slides and supernatant specimens may play in the diagnosis of malignancy in fine-needle aspirates (FNA) and biliary brushing specimens from patients with pancreaticobiliary masses. Methods Cytology results were examined in a total of 30 patients with associated surgical (10) or clinical (20) outcomes. MP of DNA from microdissected cytology slides and from discarded supernatant fluid was analyzed in 26 patients with atypical, negative or indeterminate cytology. Results Cytology correctly diagnosed aggressive disease in 4 patients. Cytological diagnoses for the remaining 26 were as follows: 16 negative (9 false negative), 9 atypical, 1 indeterminate. MP correctly determined aggressive disease in 1 false negative cytology case and confirmed a negative cytology diagnosis in 7 of 7 cases of non-aggressive disease. Of the 9 atypical cytology cases, MP correctly diagnosed 7 as positive and 1 as negative for aggressive disease. One specimen that was indeterminate by cytology was correctly diagnosed as non-aggressive by MP. When first line malignant (positive) cytology results were combined with positive second line MP results, 12/21 cases of aggressive disease were identified, compared to 4/21 cases identified by positive cytology alone. Conclusions When first line cytology results were uncertain (atypical), questionable (negative), or not possible (non-diagnostic/indeterminate), MP provided additional information regarding the presence of aggressive disease. When used in conjunction with first line cytology, MP increased detection of aggressive disease without compromising specificity in patients that were difficult to diagnose by cytology alone. PMID:25084836

  7. Food additives

    PubMed Central

    Spencer, Michael

    1974-01-01

    Food additives are discussed from the food technology point of view. The reasons for their use are summarized: (1) to protect food from chemical and microbiological attack; (2) to even out seasonal supplies; (3) to improve their eating quality; (4) to improve their nutritional value. The various types of food additives are considered, e.g. colours, flavours, emulsifiers, bread and flour additives, preservatives, and nutritional additives. The paper concludes with consideration of those circumstances in which the use of additives is (a) justified and (b) unjustified. PMID:4467857

  8. Biobased lubricant additives

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fully biobased lubricants are those formulated using all biobased ingredients, i.e. biobased base oils and biobased additives. Such formulations provide the maximum environmental, safety, and economic benefits expected from a biobased product. Currently, there are a number of biobased base oils that...

  9. 20 CFR 802.215 - Additional briefs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Additional briefs. 802.215 Section 802.215 Employees' Benefits BENEFITS REVIEW BOARD, DEPARTMENT OF LABOR RULES OF PRACTICE AND PROCEDURE Prereview Procedures Initial Processing § 802.215 Additional briefs. Additional briefs may be filed or ordered in...

  10. Benefits and Risks in Secondary Use of Digitized Clinical Data: Views of Community Members Living in a Predominantly Ethnic Minority Urban Neighborhood

    PubMed Central

    Lucero, Robert J.; Kearney, Joan; Cortes, Yamnia; Arcia, Adriana; Appelbaum, Paul; Fernández, Roberto Lewis; Luchsinger, Jose

    2015-01-01

    Background There is potential to increase the speed of scientific discovery and implement personalized health care by using digitized clinical data collected on the patient care experience. The use of these data in research raises concerns about the privacy and confidentiality of personal health information. This study explored community members’ views on the secondary use of digitized clinical data to (1) recruit participants for clinical studies; (2) recruit family members of persons with an index condition for primary studies; and (3) conduct studies of information related to stored biospecimens. Methods A qualitative descriptive design was used to examine the bioethical issues outlined from the perspective of urban-dwelling community members. Focus groups were used for data collection, and emergent content analysis was employed to organize and interpret the data. Results Thirty community members attended one of four focus groups ranging in size from 4 to 11 participants. Five critical themes emerged from the focus-group material: (1) perceived motivators for research participation; (2) objective or “real-life” barriers to research participation; (3) a psychological component of uncertainty and mistrust; (4) preferred mechanisms for recruitment and participation; and (5) cultural characteristics that can impact understanding and willingness to engage in research. Conclusions The overriding concern of community members regarding research participation and/or secondary clinical and nonclinical use of digitized information was that their involvement would be safe and the outcome would be meaningful to them and to others. According to participants, biospecimens acquired during routine clinical visits or for research are no longer possessions of the participant. Although the loss of privacy was a concern for participants, they preferred that researchers access their personal health information using a digitized clinical file rather than through a paper

  11. Maximizing Effectiveness Trials in PTSD and SUD Through Secondary Analysis: Benefits and Limitations Using the National Institute on Drug Abuse Clinical Trials Network “Women and Trauma” Study as a Case Example

    PubMed Central

    Hien, Denise A.; Campbell, Aimee N.C.; Ruglass, Lesia M.; Saavedra, Lissette; Mathews, Abigail G.; Kiriakos, Grace; Morgan-Lopez, Antonio

    2015-01-01

    Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and posttraumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on “superiority” designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment. This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses a case example of one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) and producing 19 publications. The paper concludes with implications of this secondary analytic approach to improve addiction researchers’ ability to identify best practices for community-based treatment of these disorders. Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal

  12. Maximizing Effectiveness Trials in PTSD and SUD Through Secondary Analysis: Benefits and Limitations Using the National Institute on Drug Abuse Clinical Trials Network "Women and Trauma" Study as a Case Example.

    PubMed

    Hien, Denise A; Campbell, Aimee N C; Ruglass, Lesia M; Saavedra, Lissette; Mathews, Abigail G; Kiriakos, Grace; Morgan-Lopez, Antonio

    2015-09-01

    Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and posttraumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on "superiority" designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment. This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses a case example of one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) and producing 19 publications. The paper concludes with implications of this secondary analytic approach to improve addiction researchers' ability to identify best practices for community-based treatment of these disorders. Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal

  13. Who benefits from child benefit?

    PubMed

    Blow, Laura; Walker, Ian; Zhu, Yu

    2012-01-01

    Governments, over much of the developed world, make significant financial transfers to parents with dependent children. For example, in the United States the recently introduced Child Tax Credit (CTC), which goes to almost all children, costs almost $1 billion each week, or about 0.4% of GNP. The United Kingdom has even more generous transfers and spends an average of about $30 a week on each of about 8 million children—about 1% of GNP. The typical rationale given for these transfers is that they are good for our children and here we investigate the effect of such transfers on household spending patterns. In the United Kingdom such transfers, known as Child Benefit (CB), have been simple lump sum universal payments for a continuous period of more than 20 years. We do indeed find that CB is spent differently from other income—paradoxically, it appears to be spent disproportionately on adult-assignable goods. In fact, we estimate that as much as half of a marginal dollar of CB is spent on alcohol. We resolve this puzzle by showing that the effect is confined to unanticipated variation in CB so we infer that parents are sufficiently altruistic toward their children that they completely insure them against shocks. PMID:22329051

  14. Who benefits from child benefit?

    PubMed

    Blow, Laura; Walker, Ian; Zhu, Yu

    2012-01-01

    Governments, over much of the developed world, make significant financial transfers to parents with dependent children. For example, in the United States the recently introduced Child Tax Credit (CTC), which goes to almost all children, costs almost $1 billion each week, or about 0.4% of GNP. The United Kingdom has even more generous transfers and spends an average of about $30 a week on each of about 8 million children—about 1% of GNP. The typical rationale given for these transfers is that they are good for our children and here we investigate the effect of such transfers on household spending patterns. In the United Kingdom such transfers, known as Child Benefit (CB), have been simple lump sum universal payments for a continuous period of more than 20 years. We do indeed find that CB is spent differently from other income—paradoxically, it appears to be spent disproportionately on adult-assignable goods. In fact, we estimate that as much as half of a marginal dollar of CB is spent on alcohol. We resolve this puzzle by showing that the effect is confined to unanticipated variation in CB so we infer that parents are sufficiently altruistic toward their children that they completely insure them against shocks.

  15. Commentary: Is There Clinical Benefit From Using a Diode or Neodymium:Yttrium-Aluminum-Garnet Laser in the Treatment of Periodontitis?

    PubMed

    Cobb, Charles M

    2016-10-01

    Despite a quarter of a century of laser research, there is a persistent debate regarding the efficacy of dental lasers in the treatment of periodontitis or periodontal maintenance therapy. There are many claims and much hyperbole surrounding the use of lasers, either as a monotherapy or adjunctive to scaling and root planing, to treat periodontitis. There is little evidence that using a diode or neodymium:yttrium-aluminum-garnet laser adds clinical value over and above conventional non-surgical or surgical periodontal treatment. There is a significant need for better designed human clinical trials. Data from such trials should be analyzed according to initial probing depth and characteristics of the treated sites, such as non-molar, molar flat surfaces, and molar furcations, and evaluated for long-term post-treatment results. PMID:27181116

  16. Durable Clinical Benefit of Pertuzumab in a Young Patient with BRCA2 Mutation and HER2-Overexpressing Breast Cancer Involving the Brain

    PubMed Central

    Koumarianou, Anna; Kontopoulou, Christina; Kouloulias, Vassilis; Tsionou, Christina

    2016-01-01

    Patients with HER2-positive breast cancer and brain metastases have limited treatment options, and, as a result of their poor performance status and worse prognosis, they are underrepresented in clinical trials. Not surprisingly, these patients may not be fit enough to receive any active treatment and are offered supportive therapy. BRCA2 mutations are reported to be rarely associated with HER2-overexpressing advanced breast cancer and even more rarely with brain metastases at diagnosis. We report on a BRCA2-positive breast cancer patient with metastatic disease in multiple sites, including the brain, and poor performance status who exhibited an extraordinary clinical and imaging response to the novel anti-HER2 therapy pertuzumab after multiple lines of therapy including anti-HER2 targeting. To our knowledge, the clinicopathologic and therapeutic characteristics of this patient point to a unique case and an urgent need for further investigation of pertuzumab in patients with brain metastases. PMID:27195161

  17. Commentary: Is There Clinical Benefit From Using a Diode or Neodymium:Yttrium-Aluminum-Garnet Laser in the Treatment of Periodontitis?

    PubMed

    Cobb, Charles M

    2016-10-01

    Despite a quarter of a century of laser research, there is a persistent debate regarding the efficacy of dental lasers in the treatment of periodontitis or periodontal maintenance therapy. There are many claims and much hyperbole surrounding the use of lasers, either as a monotherapy or adjunctive to scaling and root planing, to treat periodontitis. There is little evidence that using a diode or neodymium:yttrium-aluminum-garnet laser adds clinical value over and above conventional non-surgical or surgical periodontal treatment. There is a significant need for better designed human clinical trials. Data from such trials should be analyzed according to initial probing depth and characteristics of the treated sites, such as non-molar, molar flat surfaces, and molar furcations, and evaluated for long-term post-treatment results.

  18. Comparative clinical and psychosocial benefits of tooth bleaching: different light activation of a 38% peroxide gel in a preliminary case-control study.

    PubMed

    Calderini, Angelo; Sciara, Simona; Semeria, Chiara; Pantaleo, Giuseppe; Polizzi, Elisabetta

    2016-08-01

    Tooth bleaching is a widespread dental treatment with important psychosocial antecedents and outcomes involved. In the activation of in-office bleaching agents, a selective light radiation, that is, a diode laser seems to be a positive choice to decrease the time of bleaching without surface modification and with no residual tooth sensitivity for maximum effect and minimal clinical and psychological side effects. PMID:27525071

  19. Assessment of clinical benefit and quality of life in patients undergoing cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for management of peritoneal metastases

    PubMed Central

    Hanna, Nader; Boutros, Cherif; Alexander, H. Richard

    2013-01-01

    Peritoneal metastasis is a significant clinical challenge; life expectancy following diagnosis is usually very short. Surgical cytoreduction with HIPEC is being used with increasing frequency in selected patients; most outcome data have shown that prolonged median survivals can be observed in selected patients. This review summarizes the published data related to outcome and quality of life after cytoreduction and HIPEC to provide insights into its use in patients with peritoneal carcinomatosis. PMID:23450068

  20. The need for annual echocardiography to detect cabergoline-associated valvulopathy in patients with prolactinoma: a systematic review and additional clinical data.

    PubMed

    Caputo, Carmela; Prior, David; Inder, Warrick J

    2015-11-01

    Present recommendations by the US Food and Drug Administration advise that patients with prolactinoma treated with cabergoline should have an annual echocardiogram to screen for valvular heart disease. Here, we present new clinical data and a systematic review of the scientific literature showing that the prevalence of cabergoline-associated valvulopathy is very low. We prospectively assessed 40 patients with prolactinoma taking cabergoline. Cardiovascular examination before echocardiography detected an audible systolic murmur in 10% of cases (all were functional murmurs), and no clinically significant valvular lesion was shown on echocardiogram in the 90% of patients without a murmur. Our systematic review identified 21 studies that assessed the presence of valvular abnormalities in patients with prolactinoma treated with cabergoline. Including our new clinical data, only two (0·11%) of 1811 patients were confirmed to have cabergoline-associated valvulopathy (three [0·17%] if possible cases were included). The probability of clinically significant valvular heart disease is low in the absence of a murmur. On the basis of these findings, we challenge the present recommendations to do routine echocardiography in all patients taking cabergoline for prolactinoma every 12 months. We propose that such patients should be screened by a clinical cardiovascular examination and that echocardiogram should be reserved for those patients with an audible murmur, those treated for more than 5 years at a dose of more than 3 mg per week, or those who maintain cabergoline treatment after the age of 50 years.

  1. The Effect of Emphasizing Mathematical Structure in the Acquisition of Whole Number Computation Skills (Addition and Subtraction) By Seven- and Eight-Year Olds: A Clinical Investigation.

    ERIC Educational Resources Information Center

    Uprichard, A. Edward; Collura, Carolyn

    This investigation sought to determine the effect of emphasizing mathematical structure in the acquisition of computational skills by seven- and eight-year-olds. The meaningful development-of-structure approach emphasized closure, commutativity, associativity, and the identity element of addition; the inverse relationship between addition and…

  2. Clinical benefit of adenosine as an adjunct to reperfusion in ST-elevation myocardial infarction patients: An updated meta-analysis of randomized controlled trials

    PubMed Central

    Bulluck, Heerajnarain; Sirker, Alex; Loke, Yoon K.; Garcia-Dorado, David; Hausenloy, Derek J.

    2016-01-01

    Background Adenosine administered as an adjunct to reperfusion can reduce coronary no-reflow and limit myocardial infarct (MI) size in ST-segment elevation myocardial infarction (STEMI) patients. Whether adjunctive adenosine therapy can improve clinical outcomes in reperfused STEMI patients is not clear and is investigated in this meta-analysis of 13 randomized controlled trials (RCTs). Methods We performed an up-to-date search for all RCTs investigating adenosine as an adjunct to reperfusion in STEMI patients. We calculated pooled relative risks using a fixed-effect meta-analysis assessing the impact of adjunctive adenosine therapy on major clinical endpoint including all-cause mortality, non-fatal myocardial infarction, and heart failure. Surrogate markers of reperfusion were also analyzed. Results 13 RCTs (4273 STEMI patients) were identified and divided into 2 subgroups: intracoronary adenosine versus control (8 RCTs) and intravenous adenosine versus control (5 RCTs). In patients administered intracoronary adenosine, the incidence of heart failure was significantly lower (risk ratio [RR] 0.44 [95% CI 0.25–0.78], P = 0.005) and the incidence of coronary no-reflow was reduced (RR for TIMI flow<3 postreperfusion 0.68 [95% CI 0.47–0.99], P = 0.04). There was no difference in heart failure incidence in the intravenous adenosine group but most RCTs in this subgroup were from the thrombolysis era. There was no difference in non-fatal MI or all-cause mortality in both subgroups. Conclusion We find evidence of improved clinical outcome in terms of less heart failure in STEMI patients administered intracoronary adenosine as an adjunct to reperfusion. This finding will need to be confirmed in a large adequately powered prospective RCT. PMID:26402450

  3. Long-range safety and protective benefits of angiotensin-converting enzyme inhibitors for hypertension. Do we need more clinical trials?

    PubMed Central

    Sambhi, M P; Gavras, H; Robertson, J I; Smith, W M

    1993-01-01

    Inhibition of the renin-angiotensin system is being applied with considerable success to the treatment of hypertension and heart failure. Angiotensin-converting enzyme (ACE) inhibitors are the only currently available agents that can achieve this objective. In general, the major therapeutic effects of these agents in the treatment of mild to moderate hypertension or of heart failure are exerted on the vascular tissue through inhibition of the renin-angiotensin system and, secondarily, of the sympathetic nervous system. When cardiovascular functional reserve is diminished and autoregulation of regional and systemic blood flow is strained, however, ACE inhibitors may affect other organ functions (heart, kidneys, and possibly brain), hormones other than the renin system, and local tissue humoral systems. The interrelations between the renin-angiotensin system and several other vasoactive systems--including circulating and locally generated tissue hormones and centrally acting neurohormonal factors--are complex and unclear. A better understanding of these mechanisms and interrelations would allow for a more rational therapeutic use of these agents. Unknown also are the clinical effects of prolonged ACE inhibition. Whether the use of ACE inhibitors can provide primary cardiorenal protection requires proof through definitive clinical trials. Images PMID:8460511

  4. One-year clinical results of Er,Cr:YSGG laser application in addition to scaling and root planing in patients with early to moderate periodontitis.

    PubMed

    Kelbauskiene, Solveiga; Baseviciene, Nomeda; Goharkhay, Kawe; Moritz, Andreas; Machiulskiene, Vita

    2011-07-01

    In 30 patients with periodontitis, a total of 278 teeth exhibiting bleeding on probing, subgingival calculus, and a probing depth between 3-6 mm were examined. For each participant, two treatment types were alternatively applied on the contralateral quadrants: scaling and root planing (SRP) as control, and SRP followed by Er,Cr:YSGG laser application (SRP+laser), as a test method. Five clinical parameters: plaque level, bleeding on probing, probing depth, gingival recession and clinical attachment level were examined at baseline and at 2, 3, 6, 12 months after treatment. Of the total of 1,668 sites examined in all patients, 1,088 sites were found with a probing depth of 3-6 mm. In these sites, differences in clinical parameters between SRP and SRP+laser-treated quadrants were analyzed, assuming the level of p < 0.05 as significant. After 2 months from baseline, the mean probing depth reduction and the clinical attachment level gain were significantly greater in SRP+laser than in SRP quadrants, and remained so throughout the study (p < 0.001). A marked reduction of the bleeding scores occurred in all examined sites, irrespective of the treatment method. However, after 12 months, significantly less teeth exhibited bleeding on probing in SRP+laser quadrants than in SRP quadrants (p < 0.001). The mean plaque and gingival recession levels did not differ between the SRP and SRP+laser quadrants neither before nor after the treatment. The periodontal procedures either using Er,Cr:YSGG laser after SRP or SRP alone, lead to significant improvements in all clinical parameters investigated. However, laser application, as an adjunct to SRP, appeared to be more advantageous.

  5. Phosphazene additives

    DOEpatents

    Harrup, Mason K; Rollins, Harry W

    2013-11-26

    An additive comprising a phosphazene compound that has at least two reactive functional groups and at least one capping functional group bonded to phosphorus atoms of the phosphazene compound. One of the at least two reactive functional groups is configured to react with cellulose and the other of the at least two reactive functional groups is configured to react with a resin, such as an amine resin of a polycarboxylic acid resin. The at least one capping functional group is selected from the group consisting of a short chain ether group, an alkoxy group, or an aryloxy group. Also disclosed are an additive-resin admixture, a method of treating a wood product, and a wood product.

  6. Benefits of maltodextrin intake 2 hours before cholecystectomy by laparotomy in respiratory function and functional capacity: a prospective randomized clinical trial

    PubMed Central

    Zani, Fabiana Vieira Breijão; Aguilar-Nascimento, José Eduardo; Nascimento, Diana Borges Dock; da Silva, Ageo Mário Cândido; Caporossi, Fernanda Stephan; Caporossi, Cervantes

    2015-01-01

    ABSTRACT Objective: To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting. Methods: Randomized prospective clinical trial, with 92 female patients undergoing cholecystectomy by laparotomy with conventional or 2 hours shortened fasting. The variables measured were the peak expiratory flow, forced expiratory volume in the first second, forced vital capacity, dominant handgrip strength, and non-dominant handgrip strength. Evaluations were performed 2 hours before induction of anesthesia and 24 hours after the operation. Results: The two groups were similar in preoperative evaluations regarding demographic and clinical characteristics, as well as for all variables. However, postoperatively the group with shortened fasting had higher values than the group with conventional fasting for lung function tests peak expiratory flow (128.7±62.5 versus 115.7±59.9; p=0.040), forced expiratory volume in the first second (1.5±0.6 versus 1.2±0.5; p=0.040), forced vital capacity (2.3±1.1 versus 1.8±0.9; p=0.021), and for muscle function tests dominant handgrip strength (24.9±6.8 versus 18.4±7.7; p=0.001) and non-dominant handgrip strength (22.9±6.3 versus 17.0±7.8; p=0.0002). In the intragroup evaluation, there was a decrease in preoperative compared with postoperative values, except for dominant handgrip strength (25.2±6.7 versus 24.9±6.8; p=0.692), in the shortened fasting group. Conclusion: Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant handgrip strength. PMID:26154547

  7. Projecting the clinical benefits and risks of using efavirenz-containing ART regimens in women of childbearing age in Sub-Saharan Africa

    PubMed Central

    Ouattara, Eric N.; Anglaret, Xavier; Wong, Angela Y.; Chu, Jennifer; Hsu, Heather E.; Danel, Christine; Eholié, Serge; Moh, Raoul; Gabillard, Delphine; Walensky, Rochelle; Freedberg, Kenneth A.

    2013-01-01

    Objectives Our aim was to project the outcomes of using either efavirenz or nevirapine as part of initial antiretroviral therapy (ART) in women of childbearing age in Côte d’Ivoire. Methods We used an HIV computer simulation model to project both the mother’s survival and the birth defects at 10 years for a cohort of women who started ART with either efavirenz or nevirapine. The primary outcome was the ratio at 10 years of the difference in the number of women alive to the difference in the cumulative number of birth defects in women who started ART with efavirenz compared to nevirapine. In the base case analysis, the birth defect rate was 2.9% on efavirenz and 2.7% on nevirapine. In sensitivity analyses we varied all inputs across confidence intervals reported in the literature. Results In the base case analysis, for a cohort of 100,000 women, the additional number of women alive initiating ART with efavirenz at 10 years was 15 times the additional number of birth defects (women alive: nevirapine 67,969, efavirenz 68,880, difference = 911; birth defects: nevirapine 1,128, efavirenz 1,187, difference = 59). In sensitivity analysis, the teratogenicity rate with efavirenz had to be 6.3%, or 2.3 times higher than the rate with nevirapine, for the excess number of birth defects to outweigh the additional number of women alive at 10 years. Conclusions In Côte d’Ivoire, initiating ART with efavirenz instead of nevirapine is likely to substantially increase the number of women alive at 10 years with a smaller potential number of birth defects. PMID:22398569

  8. Are there long-term benefits of experiential, interprofessional education for non-specialists on clinical behaviours and outcomes in diabetes care? A cohort study

    PubMed Central

    Ching, Daniel; Forte, Denise; Aitchison, Elizabeth; Earle, Kenneth

    2016-01-01

    Objectives Our aim was to assess the impact of an educational initiative for non-specialist, healthcare professionals in the community on the process and quality measures of diabetes care delivered, and changes in their learning experiences and clinical management behaviour in the short and long term. Setting Single locality of 26 primary care practices associated with one secondary centre. Participants General practitioners and practice nurses managing 4167 patients with diabetes. Intervention A rolling 10-week, experiential, interprofessional education programme delivered to 57 practitioners and observations in practice. Primary and secondary outcome measures Primary outcomes were changes in the proportion of patients receiving foot care, urine albumin:creatinine ratio assessments and achieving National Quality Outcome Framework targets for blood pressure (<145/80 mm Hg), glycated haemoglobin (HbA1c; >86 mmol/mol (10%) and <57.4 mmol/mol (7.4%)) and total cholesterol (<5 mmol/L) thresholds. Secondary outcomes were evidence of sustained learning and changes in the number of patients referred to secondary care. Results Evaluation of care processes and quality outcomes took place 15 months after the programme was initiated. The proportion of patients with a HbA1c of <57.4 mmol/mol (7.4%) and >85 mmol/mol (10%) was significantly higher (44% vs 53% p=0.0001) and lower (12.5% vs 10%; p=0.002) respectively. There was an increase in the proportion (95% CI) of patients receiving foot care reviews (+26.0% (24.0% to 28.1%)), microalbuminuria screening (+29.8% (27.7% to 31.9%)) and who achieved targets for blood pressure (+9.6% (7.5% to 11.6%)) and total cholesterol (+14.4% (12.3% to 16.5%); p<0.001). 241 fewer patients were referred to secondary care. Increases in the healthcare professional's confidence and collaborative clinical behaviour were evident 3 years after completing the programme. Conclusions An experiential, interprofessional intervention can

  9. Allergen-specific immunotherapy provides immediate, long-term and preventive clinical effects in children and adults: the effects of immunotherapy can be categorised by level of benefit -the centenary of allergen specific subcutaneous immunotherapy

    PubMed Central

    2012-01-01

    Allergen Specific Immunotherapy (SIT) for respiratory allergic diseases is able to significantly improve symptoms as well as reduce the need for symptomatic medication, but SIT also has the capacity for long-term clinical effects and plays a protective role against the development of further allergies and symptoms. The treatment acts on basic immunological mechanisms, and has the potential to change the pathological allergic immune response. In this paper we discuss some of the most important achievements in the documentation of the benefits of immunotherapy, over the last 2 decades, which have marked a period of extensive research on the clinical effects and immunological background of the mechanisms involved. The outcome of immunotherapy is described as different levels of benefit from early reduction in symptoms over progressive clinical effects during treatment to long-term effects after discontinuation of the treatment and prevention of asthma. The efficacy of SIT increases the longer it is continued and immunological changes lead to potential long-term benefits. SIT alone and not the symptomatic treatment nor other avoidance measures has so far been documented as the therapy with long-term or preventive potential. The allergic condition is driven by a subset of T-helper lymphocytes (Th2), which are characterised by the production of cytokines like IL-4, and IL-5. Immunological changes following SIT lead to potential curative effects. One mechanism whereby immunotherapy suppresses the allergic response is through increased production of IgG4 antibodies. Induction of specific IgG4 is able to influence the allergic response in different ways and is related to immunological effector mechanisms, also responsible for the reduced late phase hyperreactivity and ongoing allergic inflammation. SIT is the only treatment which interferes with the basic pathophysiological mechanisms of the allergic disease, thereby creating the potential for changes in the long

  10. An exploratory intervention study suggests clinical benefits of training in chronic stroke to be paralleled by changes in brain activity using repeated fMRI

    PubMed Central

    Landsmann, Barbara; Pinter, Daniela; Pirker, Eva; Pichler, Gerald; Schippinger, Walter; Weiss, Elisabeth M; Mathie, Gabriel; Gattringer, Thomas; Fazekas, Franz; Enzinger, Christian

    2016-01-01

    Purpose Previous studies demonstrated changes in sensorimotor network activation over time after stroke that have been interpreted as partly compensatory. Locomotor and balance trainings may improve both mobility and cognition even in chronic stroke and thereby impact on cerebral activation patterns. We here aimed at testing these assumptions in an exploratory study to inform subsequent larger intervention studies. Patients and methods Eight patients (73.3±4.4 years) with a chronic lacunar stroke (mean interval 3.7 years after the acute event with a range from 2 to 4 years) and residual leg paresis leading to gait disturbance received a guided 5-week training focusing on mobility, endurance, and coordination. Before and afterward, they underwent clinical, neuropsychological, and gait assessments and brain MRI at 3 T including a functional ankle movement paradigm. Sixteen healthy controls (HCs; 68.8±5.4 years) followed the same protocol without intervention. Results After training, patients had improved in mobility, memory, and delayed recall of memory. While cerebral activations in HC remained completely unaltered, patients showed increased activations in the right precentral gyrus, the right and left superior frontal gyri, and the right frontal lobe, with bipedal ankle movements after training. Conclusion In this exploratory study of chronic stroke, we found not only significant effects of physical training on mobility but also distinct aspects of cognition already with a small number of highly selected patients. These improvements were paralleled by alterations in cerebral activity possibly reflecting neuronal plasticity. Larger studies including randomization are needed. PMID:26869779

  11. Single Nucleotide Polymorphisms in Regulator-Encoding Genes Have an Additive Effect on Virulence Gene Expression in a Vibrio cholerae Clinical Isolate.

    PubMed

    Carignan, Bailey M; Brumfield, Kyle D; Son, Mike S

    2016-01-01

    Vibrio cholerae is the etiological agent of the infectious disease cholera, which is characterized by vomiting and severe watery diarrhea. Recently, V. cholerae clinical isolates have demonstrated increased virulence capabilities, causing more severe symptoms with a much higher rate of disease progression than previously observed. We have identified single nucleotide polymorphisms (SNPs) in four virulence-regulatory genes (hapR, hns, luxO, and vieA) of a hypervirulent V. cholerae clinical isolate, MQ1795. Herein, all SNPs and SNP combinations of interest were introduced into the prototypical El Tor reference strain N16961, and the effects on the production of numerous virulence-related factors, including cholera toxin (CT), the toxin-coregulated pilus (TCP), and ToxT, were analyzed. Our data show that triple-SNP (hapR hns luxO and hns luxO vieA) and quadruple-SNP combinations produced the greatest increases in CT, TCP, and ToxT production. The hns and hns luxO SNP combinations were sufficient for increased TCP and ToxT production. Notably, the hns luxO vieA triple-SNP combination strain produced TCP and ToxT levels similar to those of MQ1795. Certain SNP combinations (hapR and hapR vieA) had the opposite effect on CT, TCP, and ToxT expression. Interestingly, the hns vieA double-SNP combination strain increased TCP production while decreasing CT production. Our findings suggest that SNPs identified in the four regulatory genes, in various combinations, are associated with increased virulence capabilities observed in V. cholerae clinical isolates. These studies provide insight into the evolution of highly virulent strains. IMPORTANCE Cholera, an infectious disease of the small intestine caused by the aquatic bacterium Vibrio cholerae, often results in vomiting and acute watery diarrhea. If left untreated or if the response is too slow, the symptoms can quickly lead to extreme dehydration and ultimately death of the patient. Recent anecdotal evidence of cholera

  12. Single Nucleotide Polymorphisms in Regulator-Encoding Genes Have an Additive Effect on Virulence Gene Expression in a Vibrio cholerae Clinical Isolate

    PubMed Central

    Carignan, Bailey M.; Brumfield, Kyle D.

    2016-01-01

    ABSTRACT Vibrio cholerae is the etiological agent of the infectious disease cholera, which is characterized by vomiting and severe watery diarrhea. Recently, V. cholerae clinical isolates have demonstrated increased virulence capabilities, causing more severe symptoms with a much higher rate of disease progression than previously observed. We have identified single nucleotide polymorphisms (SNPs) in four virulence-regulatory genes (hapR, hns, luxO, and vieA) of a hypervirulent V. cholerae clinical isolate, MQ1795. Herein, all SNPs and SNP combinations of interest were introduced into the prototypical El Tor reference strain N16961, and the effects on the production of numerous virulence-related factors, including cholera toxin (CT), the toxin-coregulated pilus (TCP), and ToxT, were analyzed. Our data show that triple-SNP (hapR hns luxO and hns luxO vieA) and quadruple-SNP combinations produced the greatest increases in CT, TCP, and ToxT production. The hns and hns luxO SNP combinations were sufficient for increased TCP and ToxT production. Notably, the hns luxO vieA triple-SNP combination strain produced TCP and ToxT levels similar to those of MQ1795. Certain SNP combinations (hapR and hapR vieA) had the opposite effect on CT, TCP, and ToxT expression. Interestingly, the hns vieA double-SNP combination strain increased TCP production while decreasing CT production. Our findings suggest that SNPs identified in the four regulatory genes, in various combinations, are associated with increased virulence capabilities observed in V. cholerae clinical isolates. These studies provide insight into the evolution of highly virulent strains. IMPORTANCE Cholera, an infectious disease of the small intestine caused by the aquatic bacterium Vibrio cholerae, often results in vomiting and acute watery diarrhea. If left untreated or if the response is too slow, the symptoms can quickly lead to extreme dehydration and ultimately death of the patient. Recent anecdotal evidence of

  13. Single Nucleotide Polymorphisms in Regulator-Encoding Genes Have an Additive Effect on Virulence Gene Expression in a Vibrio cholerae Clinical Isolate

    PubMed Central

    Carignan, Bailey M.; Brumfield, Kyle D.

    2016-01-01

    ABSTRACT Vibrio cholerae is the etiological agent of the infectious disease cholera, which is characterized by vomiting and severe watery diarrhea. Recently, V. cholerae clinical isolates have demonstrated increased virulence capabilities, causing more severe symptoms with a much higher rate of disease progression than previously observed. We have identified single nucleotide polymorphisms (SNPs) in four virulence-regulatory genes (hapR, hns, luxO, and vieA) of a hypervirulent V. cholerae clinical isolate, MQ1795. Herein, all SNPs and SNP combinations of interest were introduced into the prototypical El Tor reference strain N16961, and the effects on the production of numerous virulence-related factors, including cholera toxin (CT), the toxin-coregulated pilus (TCP), and ToxT, were analyzed. Our data show that triple-SNP (hapR hns luxO and hns luxO vieA) and quadruple-SNP combinations produced the greatest increases in CT, TCP, and ToxT production. The hns and hns luxO SNP combinations were sufficient for increased TCP and ToxT production. Notably, the hns luxO vieA triple-SNP combination strain produced TCP and ToxT levels similar to those of MQ1795. Certain SNP combinations (hapR and hapR vieA) had the opposite effect on CT, TCP, and ToxT expression. Interestingly, the hns vieA double-SNP combination strain increased TCP production while decreasing CT production. Our findings suggest that SNPs identified in the four regulatory genes, in various combinations, are associated with increased virulence capabilities observed in V. cholerae clinical isolates. These studies provide insight into the evolution of highly virulent strains. IMPORTANCE Cholera, an infectious disease of the small intestine caused by the aquatic bacterium Vibrio cholerae, often results in vomiting and acute watery diarrhea. If left untreated or if the response is too slow, the symptoms can quickly lead to extreme dehydration and ultimately death of the patient. Recent anecdotal evidence of

  14. Donor-derived West Nile virus infection in solid organ transplant recipients: report of four additional cases and review of clinical, diagnostic, and therapeutic features.

    PubMed

    Winston, Drew J; Vikram, Holenarasipur R; Rabe, Ingrid B; Dhillon, Gundeep; Mulligan, David; Hong, Johnny C; Busuttil, Ronald W; Nowicki, Marek J; Mone, Thomas; Civen, Rachel; Tecle, Selam A; Trivedi, Kavita K; Hocevar, Susan N

    2014-05-15

    We describe four solid-organ transplant recipients with donor-derived West Nile virus (WNV) infection (encephalitis 3, asymptomatic 1) from a common donor residing in a region of increased WNV activity. All four transplant recipients had molecular evidence of WNV infection in their serum and/or cerebrospinal fluid (CSF) by reverse transcription polymerase chain reaction (RT-PCR) testing. Serum from the organ donor was positive for WNV IgM but negative for WNV RNA, whereas his lymph node and spleen tissues tested positive for WNV by RT-PCR. Combination therapy included intravenous immunoglobulin (4 cases), interferon (3 cases), fresh frozen plasma with WNV IgG (2 cases), and ribavirin (1 case). Two of the four transplant recipients survived.Review of the 20 published cases of organ-derived WNV infection found that this infection is associated with a high incidence of neuroinvasive disease (70%) and severe morbidity and mortality (30%). Median time to onset of symptomatic WNV infection was 13 days after transplantation (range 5-37 days). Initial unexplained fever unresponsive to antibiotic therapy followed by rapid onset of neurologic deficits was the most common clinical presentation. Confirmation of infection was made by testing serum and CSF for both WNV RNA by RT-PCR and WNV IgM by serological assays. Treatment usually included supportive care, reduction of immunosuppression, and frequent intravenous immunoglobulin. The often negative results for WNV by current RT-PCR and serological assays and the absence of clinical signs of acute infection in donors contribute to the sporadic occurrence of donor-derived WNV infection. Potential organ donors should be assessed for unexplained fever and neurological symptoms, particularly if they reside in areas of increased WNV activity.

  15. Pharmacy benefit management companies.

    PubMed

    Taniguchi, R

    1995-09-01

    The principal services offered by pharmacy benefit management companies (PBMs) are described. A PBM contracts with employers, insurers, and others to provide accessible and cost-effective benefits to those groups' members. PBMs vary in their organization and services because they originate from different types of businesses. Many PBMs have been formed by publicly traded companies that have combined traditional ways of controlling cost and use, such as formularies, with new elements to form organizations whose primary function is managing the pharmacy benefit. Often, the PBM is paid a fixed amount for which it must provide all contracted services. PBMs may provide pharmacy services themselves (e.g., mail order prescription service is offered by Medco, one of the largest PBMs); more often, they subcontract with others to provide certain services. Full-service PBMs have the following functions: establishing networks of pharmacies for use by plan members; processing claims electronically at the time a prescription is filled and thus maintaining a database on drug use and cost; using these data to generate various reports; encouraging the use of generic products; managing existing formularies, helping to establish customized formularies, or providing a national formulary; providing information to support formulary guidelines (counter-detailing); offering programs in which prescriptions for maintenance medications are filled less frequently with larger amounts, often by mail order; negotiating volume-based rebates from manufacturers; performing drug-use review; developing disease management programs based on clinical practice guidelines and measurements of patient outcome; and evaluating outcomes by combining data on drug therapy with information about other parts of the patient's care.(ABSTRACT TRUNCATED AT 250 WORDS)

  16. Clinical and biochemical outcomes for additive mesenteric and lower body perfusion during hypothermic circulatory arrest for complex total aortic arch replacement surgery.

    PubMed

    Fernandes, P; Cleland, A; Adams, C; Chu, M W A

    2012-11-01

    Surgical repair of transverse aortic arch aneurysms frequently employ hypothermia and antegrade cerebral perfusion as protective strategies during circulatory arrest. However, prolonged mesenteric and lower limb ischemia can lead to significant lactic acidosis and end organ dysfunction, which remains a significant cause of post-operative morbidity and mortality. We report our experience with additive warm mesenteric and lower body perfusion (1-3 L/min, 30°C) in addition to continuous cerebral and myocardial perfusion in 5 patients who underwent total aortic arch replacement with trifurcated head vessel re-implantation and distal elephant trunk reconstruction. Concomitant surgical procedures included re-operations (2), aortic root operations (2), coronary artery bypass (2) and descending thoracic aortic replacement (1). Serum lactate levels demonstrated a rapid decline from a peak 9.9 ± 2.6 post circulatory arrest to 3.4 ± 2.0 in the intensive care unit (ICU). The lowest serum bicarbonate levels were 19.3 ± 3.5 mmol/L, intra-operatively, which normalized to 28.4 ± 2.4 mmol/L on return to the ICU. The lowest pH levels were 7.25 ± 0.10, corrected to 7.43 ± 0.04 on return to the ICU. Mean cardiopulmonary bypass and aortic cross-clamp times were 361 ± 104 and 253 ± 85 minutes, respectively. Mean cerebral and lower body circulatory arrest times were 0 (0) and 50 ± 35 minutes, respectively. The mean time required for systemic rewarming was 95 ± 66 minutes. There were no in-hospital mortalities and no patient experienced any neurological, mesenteric, renal or lower limb ischemic complications. Two patients required mechanical ventilation >24 hours, and one patient returned for reoperation for bleeding. Median intensive care unit and total hospital lengths of stay were 5 and 16 days, respectively. Our results suggest early serum lactate clearance, normalization of acidosis, and metabolic recovery when utilizing a simultaneous cerebral perfusion and warm body

  17. [Additional administration of dutasteride in patients with benign prostatic hyperplasia who did not respond sufficiently to α1-adrenoceptor antagonist : investigation of clinical factors affecting the therapeutic effect of dutasteride].

    PubMed

    Masuda, Mitsunobu; Murai, Tetsuo; Osada, Yutaka; Kawai, Masaki; Kasuga, Jun; Yokomizo, Yumiko; Kuroda, Shinnosuke; Nakamura, Mami; Noguchi, Go

    2014-02-01

    We performed additional administration of dutasteride in patients who did not respond sufficiently to α1-adrenoceptor antagonist treatment for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) (LUTS/BPH). Among 76 registered patients, efficacy was analyzed in 58 patients. International Prostate Symptom Score (IPSS), subscores for voiding and storage symptoms and quality of life (QOL) on the IPSS, and Overactive Bladder Symptom Score (OABSS) were all significantly improved from the third month of administration compared to the time of initiating additional administration of dutasteride. Additional administration of dutasteride also significantly reduced prostate volume, and residual urine with the exception of the sixth month after administration. Age at initiation of administration and voiding symptom subscore on the IPSS were clinical factors affecting the therapeutic effects of dutasteride. The rate of improvement with treatment decreased with increasing age at initiation of dutasteride administration, and increased as voiding symptom subscore on the IPSS increased. Therefore, additional administration of dutasteride appears useful for cases of LUTS/BPH in which a sufficient response is not achieved with α1-adrenoceptor antagonist treatment. Because patients who have severe voiding symptoms or begin dutasteride at an early age may be expected to respond particularly well to dutasteride in terms of clinical efficacy, they were considered to be suitable targets for additional administration. PMID:24755815

  18. Great social benefits.

    PubMed

    Huang, B

    1991-06-01

    The Integrated Project (IP), originated by the Japanese Organization for International Cooperation in Family Planning (JOICFP) was started in China in 1984. The 2nd phase covered 210,000 people in 8 townships in Inner Mongolia Autonomous Region, and others in Liaoning, Jiangsu and Shandong Provinces, in 1987-1989. 2 pilot areas, monitored by representatives from IPPF's East and Southeast Asia and Oceania Region in September 1990, showed significant gains in contraceptive prevalence as well as health benefits and community acceptance. The IP consists of integrated family planning, maternal and child health and parasite control for rural areas. In Tumotezuo County, Inner Mongolia, the village of Bashi with 2526 people was mobilized to construct its own health clinic with a delivery room and a maternal and child health unit, where night classes were held for women. Because of antihelminthic treatment, installation of water pipes and toilets, parasites were controlled. Neighboring towns benefited by treatment of common disorders such as anemia and rickets. In the pilot areas there have been no maternal deaths in 3 years, and declines in perinatal mortality from 33.3 to 17.9/1000, and in infant mortality from 35.1 to 21.5/1000. Incidence of roundworm infection fell from 27.8 to 7.6%, Contraceptive prevalence, already high at 91.8%, rose to 93.7% among the Han majority, and from 65.9 to 77.2% in minorities. Family planning was spread by using the "core household" approach. The large household of the village leader, with 13 women of childbearing age, subscribed to several periodicals on family planning and farm and home economics, so people learned how to become well off by raising vegetables and pigs, and how to limit family size with the correct concept of a happy healthy family.

  19. Interprofessional student clinics: an economic evaluation of collaborative clinical placement education.

    PubMed

    Haines, Terry P; Kent, Fiona; Keating, Jennifer L

    2014-07-01

    Interprofessional student clinics can be used to create clinical education placements for health professional students in addition to traditional hospital-based placements and present an opportunity to provide interprofessional learning experiences in a clinical context. To date, little consideration has been given in research literature as to whether such clinics are economically viable for a university to run. We conducted an economic evaluation based upon data generated during a pilot of an interprofessional student clinic based in Australia. Cost-minimization analyses of the student clinic as opposed to traditional profession-specific clinical education in hospitals were conducted from university, Commonwealth Government, state government and societal perspectives. Cost data gathered during the pilot study and market prices were used where available, while $AUD currency at 2011 values were used. Per student day of clinical education, the student clinic cost an additional $289, whereas the state government saved $49 and the Commonwealth Government saved $66. Overall, society paid an additional $175 per student day of clinical education using the student clinic as opposed to conventional hospital-based placements, indicating that traditional hospital-based placements are a cost-minimizing approach overall for providing clinical education. Although interprofessional student clinics have reported positive patient and student learning outcomes, further research is required to determine if these benefits can justify the additional cost of this model of education. Considerations for clinic sustainability are proposed.

  20. Interprofessional student clinics: an economic evaluation of collaborative clinical placement education.

    PubMed

    Haines, Terry P; Kent, Fiona; Keating, Jennifer L

    2014-07-01

    Interprofessional student clinics can be used to create clinical education placements for health professional students in addition to traditional hospital-based placements and present an opportunity to provide interprofessional learning experiences in a clinical context. To date, little consideration has been given in research literature as to whether such clinics are economically viable for a university to run. We conducted an economic evaluation based upon data generated during a pilot of an interprofessional student clinic based in Australia. Cost-minimization analyses of the student clinic as opposed to traditional profession-specific clinical education in hospitals were conducted from university, Commonwealth Government, state government and societal perspectives. Cost data gathered during the pilot study and market prices were used where available, while $AUD currency at 2011 values were used. Per student day of clinical education, the student clinic cost an additional $289, whereas the state government saved $49 and the Commonwealth Government saved $66. Overall, society paid an additional $175 per student day of clinical education using the student clinic as opposed to conventional hospital-based placements, indicating that traditional hospital-based placements are a cost-minimizing approach overall for providing clinical education. Although interprofessional student clinics have reported positive patient and student learning outcomes, further research is required to determine if these benefits can justify the additional cost of this model of education. Considerations for clinic sustainability are proposed. PMID:24417539

  1. Randomized pilot study and qualitative evaluation of a clinical decision support system for brain tumour diagnosis based on SV ¹H MRS: evaluation as an additional information procedure for novice radiologists.

    PubMed

    Sáez, Carlos; Martí-Bonmatí, Luis; Alberich-Bayarri, Angel; Robles, Montserrat; García-Gómez, Juan M

    2014-02-01

    The results of a randomized pilot study and qualitative evaluation of the clinical decision support system Curiam BT are reported. We evaluated the system's feasibility and potential value as a radiological information procedure complementary to magnetic resonance (MR) imaging to assist novice radiologists in diagnosing brain tumours using MR spectroscopy (1.5 and 3.0T). Fifty-five cases were analysed at three hospitals according to four non-exclusive diagnostic questions. Our results show that Curiam BT improved the diagnostic accuracy in all the four questions. Additionally, we discuss the findings of the users' feedback about the system, and the further work to optimize it for real environments and to conduct a large clinical trial. PMID:24480160

  2. Exercise: Benefits of Exercise

    MedlinePlus

    ... version of this page please turn Javascript on. Exercise: Benefits of Exercise Health Benefits One of the Healthiest Things You ... activity campaign from the National Institute on Aging. Exercise or Physical Activity? Some people may wonder what ...

  3. Benefits Outgrow Salaries

    ERIC Educational Resources Information Center

    Chemical and Engineering News, 1973

    1973-01-01

    Discusses employee benefits offered to various manufacturing industry workers, especially for chemical professionals. Indicates that in the chemicals and allied products industry, such benefits averaged more than 30 percent of payroll in 1971. (CC)

  4. DEVELOPMENT OF A PRELIMINARY CLINICAL PREDICTION RULE TO IDENTIFY PATIENTS WITH NECK PAIN THAT MAY BENEFIT FROM A STANDARDIZED PROGRAM OF STRETCHING AND MUSCLE PERFORMANCE EXERCISE: A PROSPECTIVE COHORT STUDY

    PubMed Central

    Kolber, Morey J.; George, Steven Z.; Young, Ian; Patel, Chetan K.; Cleland, Joshua A.

    2013-01-01

    Background and Purpose: Neck pain is a significant problem and many treatment options exist. While some studies suggest exercise is beneficial for individuals with non‐specific neck pain clinicians have few tools to assist in the decision making process. Therefore, the purpose of this study was to derive a preliminary clinical prediction rule (CPR) for identifying patients with neck pain (NP) who may respond to an exercise‐based treatment program. Exercise‐based interventions have demonstrated positive outcomes in patients with NP, however it is unclear which patients are more likely to respond to this treatment approach. Methods: Consecutive patients with a primary report of nonspecific NP with or without arm pain were recruited. All patients participated in a standardized exercise program and then were classified as having a successful or non‐successful outcome at 6 weeks. Potential predictor variables were entered into a stepwise regression analysis. Variables retained in the regression model were used to develop a multivariate CPR that can be used to classify patients with NP that may benefit from exercise‐based treatment. A 6‐month follow up of the patients was used to evaluate the long‐term effects. Results: Ninety‐one patients were enrolled in the study of which 50 had a successful outcome. A CPR with 5 variables was identified (Neck Disability Index score < 18/50, presence of shoulder protraction during static postural assessment, patient does not bicycle for exercise, cervical side bending < 32°, and Fear Avoidance Belief Questionnaire–Physical Activity Score < 15). If 4 of the 5 variables were present, the probability of a successful outcome shifted from 56% to 78% (+LR 2.97). At 6 months no significant difference existed in self‐reported outcomes between those considered positive on the rule for a successful outcome and those negative on the rule for a successful outcome. Conclusions: The proposed CPR may identify patients with NP

  5. Refactoring and Its Benefits

    NASA Astrophysics Data System (ADS)

    Veerraju, R. P. S. P.; Rao, A. Srinivasa; Murali, G.

    2010-10-01

    Refactoring is a disciplined technique for restructuring an existing body of code, altering its internal structure without changing its external behavior. It improves internal code structure without altering its external functionality by transforming functions and rethinking algorithms. It is an iterative process. Refactoring include reducing scope, replacing complex instructions with simpler or built-in instructions, and combining multiple statements into one statement. By transforming the code with refactoring techniques it will be faster to change, execute, and download. It is an excellent best practice to adopt for programmers wanting to improve their productivity. Refactoring is similar to things like performance optimizations, which are also behavior- preserving transformations. It also helps us find bugs when we are trying to fix a bug in difficult-to-understand code. By cleaning things up, we make it easier to expose the bug. Refactoring improves the quality of application design and implementation. In general, three cases concerning refactoring. Iterative refactoring, Refactoring when is necessary, Not refactor. Mr. Martin Fowler identifies four key reasons to refractor. Refactoring improves the design of software, makes software easier to understand, helps us find bugs and also helps in executing the program faster. There is an additional benefit of refactoring. It changes the way a developer thinks about the implementation when not refactoring. There are the three types of refactorings. 1) Code refactoring: It often referred to simply as refactoring. This is the refactoring of programming source code. 2) Database refactoring: It is a simple change to a database schema that improves its design while retaining both its behavioral and informational semantics. 3) User interface (UI) refactoring: It is a simple change to the UI which retains its semantics. Finally, we conclude the benefits of Refactoring are: Improves the design of software, Makes software

  6. Population genetics and benefit sharing.

    PubMed

    Knoppers, B M

    2000-01-01

    The majority of international or national guidelines, specific to human genetics concentrate on actual or potential clinical applications. In contrast, the Ethics Committee of the Human Genome Organisation (HUGO) attempts to provide guidance to the bench scientists engaged in fundamental research in genomics prior to any clinical applications. Often confused as constituting the Human Genome Project (HGP) itself, HUGO's (Human Genome Organization) ultimate goal is to assist in the worldwide collaboration underpinning the HGP. It is an international organisation with 1,229 members in approximately 60 countries. The Ethics Committee is one of HUGO's six international advisory committees. Composed of experts from a number of countries and disciplines, the HUGO Ethics Committee promotes discussion and understanding of social, legal, and ethical issues as they relate to the conduct of, and knowledge derived from, the Genome Initiative. Currently, it has 13 members from 11 difference countries. It has produced statements on the conduct of genetic research, on cloning, and, has most recently presented a 'Statement on Benefit-Sharing', April 11, 2000. The Intellectual Property Committee of HUGO has been active in the controversial area of patenting. The issue of benefit-sharing is one that has its source in the mandate of both committees. How to avoid both commodification of the person through payment for access to DNA and biopiracy with no return to benefits to the families or community? While patents are a legitimate form of recognition for innovation, there seems to be no therapeutic exception to some of its stringent rules and the 'morality' exclusion has lain dormant. The HUGO 'Statement on Benefit-Sharing' examines the issues of defining community, common heritage, distributive justice and solidarity before arriving at its conclusions in benefit-sharing. This communication reviews some of these issues. PMID:11878345

  7. [Costs and benefits of quality management].

    PubMed

    Schroeder-Printzen, I

    2014-01-01

    The establishment of quality management (QM) has been mandatory for health care providers of the national health insurance since 2004; however, certification is so far only compulsory for rehabilitation clinics. The costs have so far only been quantified in a few medical studies, while they are widely known in business administration with a basic distinction made between planning, steering, auditing, and declaration costs. Another business economics approach differentiates between prevention, appraisal, and non-conformance costs. The benefits of QM relates to customers, employees, external service providers, and health insurance providers. Also important in our consideration of the patient as a customer is that they should not be considered a customer in the usual business sense because the patient is in an emergency situation and can not freely decide. Improvements in treatment quality and in reducing the rate of adverse events make up the largest portion of the benefits of QM. Furthermore, QM can have a positive influence on motivation and employee recruitment. In addition, the cost savings that result despite costs for QM must not be forgotten.

  8. [Costs and benefits of quality management].

    PubMed

    Schroeder-Printzen, I

    2014-01-01

    The establishment of quality management (QM) has been mandatory for health care providers of the national health insurance since 2004; however, certification is so far only compulsory for rehabilitation clinics. The costs have so far only been quantified in a few medical studies, while they are widely known in business administration with a basic distinction made between planning, steering, auditing, and declaration costs. Another business economics approach differentiates between prevention, appraisal, and non-conformance costs. The benefits of QM relates to customers, employees, external service providers, and health insurance providers. Also important in our consideration of the patient as a customer is that they should not be considered a customer in the usual business sense because the patient is in an emergency situation and can not freely decide. Improvements in treatment quality and in reducing the rate of adverse events make up the largest portion of the benefits of QM. Furthermore, QM can have a positive influence on motivation and employee recruitment. In addition, the cost savings that result despite costs for QM must not be forgotten. PMID:24452399

  9. Performance Boosting Additive

    NASA Technical Reports Server (NTRS)

    1999-01-01

    Mainstream Engineering Corporation was awarded Phase I and Phase II contracts from Goddard Space Flight Center's Small Business Innovation Research (SBIR) program in early 1990. With support from the SBIR program, Mainstream Engineering Corporation has developed a unique low cost additive, QwikBoost (TM), that increases the performance of air conditioners, heat pumps, refrigerators, and freezers. Because of the energy and environmental benefits of QwikBoost, Mainstream received the Tibbetts Award at a White House Ceremony on October 16, 1997. QwikBoost was introduced at the 1998 International Air Conditioning, Heating, and Refrigeration Exposition. QwikBoost is packaged in a handy 3-ounce can (pressurized with R-134a) and will be available for automotive air conditioning systems in summer 1998.

  10. Maintenance of Clinical Efficacy and Radiographic Benefit Through Two Years of Ustekinumab Therapy in Patients With Active Psoriatic Arthritis: Results From a Randomized, Placebo‐Controlled Phase III Trial

    PubMed Central

    Puig, Lluís; Gottlieb, Alice B.; Ritchlin, Christopher; Li, Shu; Wang, Yuhua; Mendelsohn, Alan M.; Song, Michael; Zhu, Yaowei; Rahman, Proton; McInnes, Iain B.

    2015-01-01

    Objective To evaluate the efficacy and safety of ustekinumab through 2 years in adult patients with active psoriatic arthritis (PsA). Methods A total of 615 adult patients with active PsA were randomized to placebo, ustekinumab 45 mg, or ustekinumab 90 mg, at weeks 0, 4, and every 12 weeks through week 88 (last dose). At week 16, patients with <5% improvement in both tender and swollen joint counts entered blinded early escape (placebo to 45 mg, 45 mg to 90 mg, and 90 mg to 90 mg). All remaining placebo patients crossed over to ustekinumab 45 mg at week 24. Clinical efficacy measures included American College of Rheumatology criteria for 20% improvement (ACR20), Disease Activity Score in 28 joints using the C‐reactive protein level (DAS28‐CRP), and ≥75% improvement in the Psoriasis Area and Severity Index (PASI75). Radiographic progression was evaluated using the modified Sharp/van der Heijde score (SHS). Results At week 100, ACR20, DAS28‐CRP moderate/good response, and PASI75 rates ranged from 56.7–63.6%, 71.9–76.7%, and 63.9–72.5%, respectively, across the 3 treatment groups. In both ustekinumab groups, the median percent improvement in dactylitis and enthesitis was 100% at week 100. The mean changes in SHS score from week 52 to week 100 were similar to those observed from week 0 to week 52 in the ustekinumab groups. Through week 108, 70.7% and 9.7% of patients had an adverse event (AE) or serious AE, respectively. The rates and type of AEs were similar between the dose groups. Conclusion Clinical and radiographic benefits from ustekinumab treatment were maintained through week 100 in the PSUMMIT 1 study. No unexpected safety events were observed; the safety profile of ustekinumab in this population was similar to that previously observed in psoriasis patients treated with ustekinumab. PMID:26097039

  11. Emerging technologies in arthroplasty: additive manufacturing.

    PubMed

    Banerjee, Samik; Kulesha, Gene; Kester, Mark; Mont, Michael A

    2014-06-01

    Additive manufacturing is an industrial technology whereby three-dimensional visual computer models are fabricated into physical components by selectively curing, depositing, or consolidating various materials in consecutive layers. Although initially developed for production of simulated models, the technology has undergone vast improvements and is currently increasingly being used for the production of end-use components in various aerospace, automotive, and biomedical specialties. The ability of this technology to be used for the manufacture of solid-mesh-foam monolithic and coated components of complex geometries previously considered unmanufacturable has attracted the attention of implant manufacturers, bioengineers, and orthopedic surgeons. Currently, there is a paucity of reports describing this fabrication method in the orthopedic literature. Therefore, we aimed to briefly describe this technology, some of the applications in other orthopedic subspecialties, its present use in hip and knee arthroplasty, and concerns with the present form of the technology. As there are few reports of clinical trials presently available, the true benefits of this technology can only be realized when studies evaluating the clinical and radiographic outcomes of cementless implants manufactured with additive manufacturing report durable fixation, less stress shielding, and better implant survivorship. Nevertheless, the authors believe that this technology holds great promise and may potentially change the conventional methods of casting, machining, and tooling for implant manufacturing in the future. PMID:24764230

  12. Emerging technologies in arthroplasty: additive manufacturing.

    PubMed

    Banerjee, Samik; Kulesha, Gene; Kester, Mark; Mont, Michael A

    2014-06-01

    Additive manufacturing is an industrial technology whereby three-dimensional visual computer models are fabricated into physical components by selectively curing, depositing, or consolidating various materials in consecutive layers. Although initially developed for production of simulated models, the technology has undergone vast improvements and is currently increasingly being used for the production of end-use components in various aerospace, automotive, and biomedical specialties. The ability of this technology to be used for the manufacture of solid-mesh-foam monolithic and coated components of complex geometries previously considered unmanufacturable has attracted the attention of implant manufacturers, bioengineers, and orthopedic surgeons. Currently, there is a paucity of reports describing this fabrication method in the orthopedic literature. Therefore, we aimed to briefly describe this technology, some of the applications in other orthopedic subspecialties, its present use in hip and knee arthroplasty, and concerns with the present form of the technology. As there are few reports of clinical trials presently available, the true benefits of this technology can only be realized when studies evaluating the clinical and radiographic outcomes of cementless implants manufactured with additive manufacturing report durable fixation, less stress shielding, and better implant survivorship. Nevertheless, the authors believe that this technology holds great promise and may potentially change the conventional methods of casting, machining, and tooling for implant manufacturing in the future.

  13. The Benefits of Meditation for Outdoor Education.

    ERIC Educational Resources Information Center

    Ettenger, Jim

    Outdoor education is not merely about learning outdoor skills; it should also involve self-reflective activities. Meditation is a technique used for self-reflection, has many proven psychological and physiological benefits, and would be a good addition to any wilderness program. Research has shown that the psychological benefits of meditation…

  14. 42 CFR 422.102 - Supplemental benefits.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Supplemental benefits. (a) Mandatory supplemental benefits. (1) Subject to CMS approval, an MA organization may require Medicare enrollees of an MA plan (other than an MSA plan) to accept or pay for services in addition to Medicare-covered services described in § 422.101. (2) If the MA organization imposes...

  15. [Benefit assessment of medical devices].

    PubMed

    Zens, Yvonne; Fujita-Rohwerder, N; Windeler, J

    2015-03-01

    Medical devices play an important role in both the diagnostic and therapeutic care of patients. The hope is that particularly innovative medical devices can contribute to the improvement of patient care. However, there is no mandatory need to conduct clinical studies with medical devices that allow an assessment of their benefit within the framework of EU market access or on the way to reimbursement by the statutory health insurance (SHI) in Germany. Numerous examples show that the existing legal framework for market access and for reimbursement in the SHI system is insufficient for providing patients with only those examination and treatment methods, i. e., medical devices, that comply with the benefit requirement and the imperative for quality stipulated in the Social Code Book V. However, it is possible to conduct meaningful clinical trials, i. e., randomized controlled trials, with medical devices as well. Hence, regular, indication-related benefit assessment of medical devices with a higher risk class as a prerequisite for reimbursement for a specific medical device is not only necessary, but also feasible. The 2014 report of the Advisory Council on the Assessment of Developments in the Healthcare System contains a promising recommendation for implementing this. A regulatory framework as described in the report would allow patients the fastest possible access to safe and effective medical device innovations, while increasing planning reliability for the development and marketing of new products, which has often been criticized as insufficient by manufacturers. PMID:25566843

  16. Benefits of Java

    MedlinePlus

    ... and Facts Fitness Fitness Find out more Categories Sports and Performance Training and Recovery Exercise Topics Fueling Your Workout Benefits of Physical Activity Exercise Nutrition Top Articles Man ...

  17. Vitamin D and health issues--questioned benefits.

    PubMed

    Pines, A

    2014-12-01

    The easy access to measurement of serum 25-hydroxyvitamin D (vitD) levels created a surge in interest to learn more of its potential health benefits and its association with prevention of chronic diseases. VitD effects on bone and fracture risk were studied extensively, resulting in clinical guides that stress the need for adequate vitD supplementation. In addition, data are accumulating on its relevance to cardiovascular disease, cancer, cognition and other health domains. Recent studies and meta-analyses seem to lower this enthusiasm concerning the expected good outcomes of higher vitD levels in regard to reduction of risk for major chronic diseases in the general population. However, data are more supportive on various benefits in the case of vitamin D deficiency states, especially in older people. The following article is a short review of the latest developments in this regard. PMID:25203615

  18. Clinical Prediction Rule for Patient Outcome after In-Hospital CPR: A New Model, Using Characteristics Present at Hospital Admission, to Identify Patients Unlikely to Benefit from CPR after In-Hospital Cardiac Arrest

    PubMed Central

    Merja, Satyam; Lilien, Ryan H; Ryder, Hilary F

    2015-01-01

    BACKGROUND Physicians and patients frequently overestimate likelihood of survival after in-hospital cardiopulmonary resuscitation. Discussions and decisions around resuscitation after in-hospital cardiopulmonary arrest often take place without adequate or accurate information. METHODS We conducted a retrospective chart review of 470 instances of resuscitation after in-hospital cardiopulmonary arrest. Individuals were randomly assigned to a derivation cohort and a validation cohort. Logistic Regression and Linear Discriminant Analysis were used to perform multivariate analysis of the data. The resultant best performing rule was converted to a weighted integer tool, and thresholds of survival and nonsurvival were determined with an attempt to optimize sensitivity and specificity for survival. RESULTS A 10-feature rule, using thresholds for survival and nonsurvival, was created; the sensitivity of the rule on the validation cohort was 42.7% and specificity was 82.4%. In the Dartmouth Score (DS), the features of age (greater than 70 years of age), history of cancer, previous cardiovascular accident, and presence of coma, hypotension, abnormal PaO2, and abnormal bicarbonate were identified as the best predictors of nonsurvival. Angina, dementia, and chronic respiratory insufficiency were selected as protective features. CONCLUSIONS Utilizing information easily obtainable on admission, our clinical prediction tool, the DS, provides physicians individualized information about their patients’ probability of survival after in-hospital cardiopulmonary arrest. The DS may become a useful addition to medical expertise and clinical judgment in evaluating and communicating an individual’s probability of survival after in-hospital cardiopulmonary arrest after it is validated by other cohorts. PMID:26448686

  19. Hospital benefit segmentation.

    PubMed

    Finn, D W; Lamb, C W

    1986-12-01

    Market segmentation is an important topic to both health care practitioners and researchers. The authors explore the relative importance that health care consumers attach to various benefits available in a major metropolitan area hospital. The purposes of the study are to test, and provide data to illustrate, the efficacy of one approach to hospital benefit segmentation analysis.

  20. [What is cost benefit analysis?].

    PubMed

    Pedersen, K M; Alban, A; Danneskiold-Samsøe, B

    1990-01-01

    The practical and theoretical bases of cost-benefit analysis are reviewed systematically with particular emphasis on how an analysis can be carried out in practice. A Danish analysis about introduction of vaccination for mumps, measles and German measles is included as a common example. The great significance of elucidating the socio-economical questions to be answered before commencing an analysis is emphasized. It is therefore recommended that, among other things, as a side-effect of the actual cost-benefit analysis, a cash-analysis and a budget analysis should be carried out to identify the parties involved in the immediate expenses and incomes. This is particularly important in the cases where the same parties have a central position in the decision-making processes concerned in the project. In addition, costs and benefits are frequently distributed differently in time in different ways: Short-term expenses and long-term benefits. In connection with decision-making, this may also involve problems and should, therefore, be elucidated in detail. Similarly, the importance of including many alternatives in the analysis is emphasized and illustrated. In conclusion, it is demonstrated how well the theoretical principles have been followed, the employment and the process which led to the concrete analysis.

  1. Benefits of Breastfeeding

    MedlinePlus

    ... size | Print | Skip left navigation It's Only Natural Planning ahead Breastfeeding and baby basics Making breastfeeding work for you Making the decision to breastfeed Secrets to breastfeeding success The benefits ...

  2. Benefits and costs of integrating technology into undergraduate nursing programs.

    PubMed

    Glasgow, Mary Ellen Smith; Cornelius, Frances H

    2005-01-01

    Advances in technology over the last decade have resulted in increased opportunities for educators to become more innovative in classroom and clinical teaching. These innovations have allowed students and faculty to access essential clinical information at the point of care/need. By capitalizing on technologies such as personal digital assistants and course delivery shells, faculty and students have both portable and remote access to information that can guide practice and learning activities in clinical, classroom, and distance settings. For instance, a student can use a personal digital assistant to research a patient's new medication at the bedside, study course information, access references during class in response to a question, or download clinical materials from home. Although the benefits of having ready access to information seem obvious, there are costs and strategic planning activities associated with implementing these projects. Clearly, the objective of any academic nursing program is to develop skills among students so they can efficiently access information and use that information to guide their nursing practice. To do so, academic nursing administrators must have the forethought to envision how new technologies can support achieving this goal as well as the ability to put in place the infrastructure supports needed for success. This article presents a case study of how one institution developed the necessary infrastructure and garnished the appropriate resources to implement an ambitious technology initiative integrated throughout a large undergraduate nursing program. In addition, how the integration of technology, online and mobile, can enhance clinical learning will be discussed.

  3. [Administrative deconcentration and social benefits].

    PubMed

    Palma, E; Rufián, D

    1990-01-01

    This paper defines the concepts of deconcentration and decentralization in terms of the different approaches and doctrines that relate to the two processes. In addition, it describes the two types of deconcentration, functional and territorial, stressing the importance of implementing both types and placing special emphasis on the role of space both in the structure of health service administration and in the distribution of authority between the State and the decentralized agencies. Finally, the relationship between deconcentration, democracy, community participation, and social benefits is analyzed, and possible ways to shift responsibility to decentralized agencies are suggested.

  4. Benefits of Required Counseling for Counseling Students

    ERIC Educational Resources Information Center

    Prosek, Elizabeth A.; Holm, Jessica M.; Daly, Cynthia M.

    2013-01-01

    Graduate students experience mental health distress. The authors investigated the benefits of required counseling services at a training clinic for students enrolled in counseling courses. Results indicated that after receiving services, students ("N" = 55) reported decreases in overall problems, depressive symptoms, and anxiety…

  5. Remote Ischemic Conditioning: Its Benefits and Limitations.

    PubMed

    Kloner, Robert A

    2016-03-01

    This editorial describes benefits and limitations of remote ischemic conditioning. Remote ischemic conditioning was shown to reduce myocardial intact size in at least 4 sizeable clinical trials of acute myocardial infarction. It was not effective in recent studies of cardiac surgery. Reasons for these differences are discussed.

  6. MAO inhibitors: risks, benefits, and lore.

    PubMed

    Wimbiscus, Molly; Kostenko, Olga; Malone, Donald

    2010-12-01

    Monoamine oxidase (MAO) inhibitors were the first antidepressants introduced, but their use has dwindled because of their reported side effects, their food and drug interactions, and the introduction of other classes of agents. However, interest in MAO inhibitors is reviving. Here, we discuss their use, risks, and benefits in clinical medicine.

  7. 38 CFR 71.40 - Caregiver benefits.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... provided through: (i) Online and in-person educational sessions. (ii) Use of telehealth and other available... monitoring will occur no less often than every 90 days, unless otherwise clinically indicated, and will... beneficiary travel under 38 CFR part 70. (c) Primary Family Caregiver benefits. VA will provide to...

  8. 20 CFR 404.1919 - How benefits are recomputed.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false How benefits are recomputed. 404.1919 Section 404.1919 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY... will recompute the pro rata PIA only if the inclusion of the additional earnings results in an...

  9. Health Benefits of Fruits and Vegetables1

    PubMed Central

    Slavin, Joanne L.; Lloyd, Beate

    2012-01-01

    Fruits and vegetables are universally promoted as healthy. The Dietary Guidelines for Americans 2010 recommend you make one-half of your plate fruits and vegetables. Myplate.gov also supports that one-half the plate should be fruits and vegetables. Fruits and vegetables include a diverse group of plant foods that vary greatly in content of energy and nutrients. Additionally, fruits and vegetables supply dietary fiber, and fiber intake is linked to lower incidence of cardiovascular disease and obesity. Fruits and vegetables also supply vitamins and minerals to the diet and are sources of phytochemicals that function as antioxidants, phytoestrogens, and antiinflammatory agents and through other protective mechanisms. In this review, we describe the existing dietary guidance on intake of fruits and vegetables. We also review attempts to characterize fruits and vegetables into groups based on similar chemical structures and functions. Differences among fruits and vegetables in nutrient composition are detailed. We summarize the epidemiological and clinical studies on the health benefits of fruits and vegetables. Finally, we discuss the role of fiber in fruits and vegetables in disease prevention. PMID:22797986

  10. Manifestations and clinical impact of pediatric inherited thrombophilia.

    PubMed

    Klaassen, Irene L M; van Ommen, C Heleen; Middeldorp, Saskia

    2015-02-12

    The etiology of pediatric venous thromboembolic disease (VTE) is multifactorial, and in most children, 1 or more clinical risk factors are present. In addition, inherited thrombophilic disorders contribute to the development of pediatric VTE. In this review, the role of inherited thrombophilic disorders in the development of pediatric VTE, as well as the benefits and limitations of thrombophilia testing, will be discussed.

  11. Clinical Usefulness of the Oppositional Defiant Disorder Rating Scale (ODDRS)

    ERIC Educational Resources Information Center

    O'Laughlin, Elizabeth M.; Hackenberg, Jessica L.; Riccardi, Maria M.

    2010-01-01

    The present study examined the reliability, validity, and clinical utility of the "Oppositional Defiant Disorder Rating Scale" (ODDRS) in a population of children referred for ADHD evaluation. The diagnostic benefit of using a rating scale specific to Oppositional Defiant Disorder (ODD), in addition to a broad range behavior scale, was also…

  12. Teacher Retirement Benefits

    ERIC Educational Resources Information Center

    Costrell, Robert; Podgursky, Michael

    2009-01-01

    The ongoing global financial crisis is forcing many employers, from General Motors to local general stores, to take a hard look at the costs of the compensation packages they offer employees. For public school systems, this will entail a consideration of fringe benefit costs, which in recent years have become an increasingly important component of…

  13. The Benefits of Latin?

    ERIC Educational Resources Information Center

    Holliday, Lisa R.

    2012-01-01

    Classicists have long claimed that the study of Latin has benefits that exceed knowledge of the language itself, and in the current economic times, these claims are made with urgency. Indeed, many contend that Latin improves English grammar and writing skills, cognitive abilities, and develops transferable skills necessary for success in the…

  14. Benefits of Conducting Research.

    ERIC Educational Resources Information Center

    Anderson, Frances E.

    2001-01-01

    Metaphors for researchers, such as a crusader; a traveler; an explorer; a miner; an astronaut; a biblical Daniel; a Samurai; and an archaeologist are discussed. Benefits of conducting research are enumerated, including building the knowledge base for art therapy; increasing professional opportunities; improving client care; and advancing the…

  15. More Benefits of Automation.

    ERIC Educational Resources Information Center

    Getz, Malcolm

    1988-01-01

    Describes a study that measured the benefits of an automated catalog and automated circulation system from the library user's point of view in terms of the value of time saved. Topics discussed include patterns of use, access time, availability of information, search behaviors, and the effectiveness of the measures used. (seven references)…

  16. Space for Mankind's Benefit.

    ERIC Educational Resources Information Center

    von Puttkamer, Jesco, Ed.; McCullough, Thomas J., Ed.

    Presented are the proceedings of the first international Congress on "Space for Mankind's Benefit" organized by the Huntsville Association of Technical Societies and held November 15-19, 1971, at Huntsville, Alabama. Following introductory statements, a total of 45 articles read in 10 sessions are incorporated. The session headings are: Man in…

  17. Costs and benefits

    NASA Technical Reports Server (NTRS)

    1975-01-01

    Two models of cost benefit analysis are illustrated and the application of these models to assessing the economic scope of space applications programs was discussed. Four major areas cited as improvable through space derived information - food supply and distribution, energy sources, mineral reserves, and communication and navigation were - discussed. Specific illustrations are given for agriculture and maritime traffic.

  18. Inclusion: Who Really Benefits?

    ERIC Educational Resources Information Center

    Wilson-Younger, Dylinda

    2009-01-01

    Since the reauthorization of 2003, schools across the nation are mandated to educate students within the regular educational environment. What impact does this merger have on students and teachers? Who really benefits from this merger of regular education and special education? This article discusses the attitudes of general education teachers…

  19. Clinical simulation: A method for development and evaluation of clinical information systems.

    PubMed

    Jensen, Sanne; Kushniruk, Andre W; Nøhr, Christian

    2015-04-01

    Use of clinical simulation in the design and evaluation of eHealth systems and applications has increased during the last decade. This paper describes a methodological approach for using clinical simulations in the design and evaluation of clinical information systems. The method is based on experiences from more than 20 clinical simulation studies conducted at the ITX-lab in the Capital Region of Denmark during the last 5 years. A ten-step approach to conducting simulations is presented in this paper. To illustrate the approach, a clinical simulation study concerning implementation of Digital Clinical Practice Guidelines in a prototype planning and coordination module is presented. In the case study potential benefits were assessed in a full-scale simulation test including 18 health care professionals. The results showed that health care professionals can benefit from such a module. Unintended consequences concerning terminology and changes in the division of responsibility amongst healthcare professionals were also identified, and questions were raised concerning future workflow across sector borders. Furthermore unexpected new possible benefits concerning improved communication, content of information in discharge letters and quality management emerged during the testing. In addition new potential groups of users were identified. The case study is used to demonstrate the potential of using the clinical simulation approach described in the paper.

  20. Nutritional constituents and health benefits of wild rice (Zizania spp.).

    PubMed

    Surendiran, Gangadaran; Alsaif, Maha; Kapourchali, Fatemeh Ramezani; Moghadasian, Mohammed H

    2014-04-01

    Wild rice (Zizania spp.) seems to have originated in North America and then dispersed into Eastern Asia and other parts of the world. Nutritional analysis shows that wild rice is rich in minerals, vitamins, protein, starch, dietary fiber, and various antioxidant phytochemicals, while it is low in fat. Wild rice has been recognized as a whole grain by the US Food and Drug Administration; in the North American marketplace it is currently sold as and considered to be a health-promoting food. Recent scientific studies have revealed antioxidant and lipid-lowering properties of wild rice, while others have documented cardiovascular benefits associated with the long-term consumption of wild rice in experimental settings. The present review article summarizes various features of wild rice and its cultivation, including its plantation, harvest, nutritional composition, and biological properties. While evidence for the cardiovascular benefits of wild rice consumption is accumulating, additional studies are warranted to determine the clinical benefits of regular consumption of wild rice.

  1. Effects of Dairy Products Consumption on Health: Benefits and Beliefs--A Commentary from the Belgian Bone Club and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.

    PubMed

    Rozenberg, Serge; Body, Jean-Jacques; Bruyère, Olivier; Bergmann, Pierre; Brandi, Maria Luisa; Cooper, Cyrus; Devogelaer, Jean-Pierre; Gielen, Evelien; Goemaere, Stefan; Kaufman, Jean-Marc; Rizzoli, René; Reginster, Jean-Yves

    2016-01-01

    Dairy products provide a package of essential nutrients that is difficult to obtain in low-dairy or dairy-free diets, and for many people it is not possible to achieve recommended daily calcium intakes with a dairy-free diet. Despite the established benefits for bone health, some people avoid dairy in their diet due to beliefs that dairy may be detrimental to health, especially in those with weight management issues, lactose intolerance, osteoarthritis, rheumatoid arthritis, or trying to avoid cardiovascular disease. This review provides information for health professionals to enable them to help their patients make informed decisions about consuming dairy products as part of a balanced diet. There may be a weak association between dairy consumption and a possible small weight reduction, with decreases in fat mass and waist circumference and increases in lean body mass. Lactose intolerant individuals may not need to completely eliminate dairy products from their diet, as both yogurt and hard cheese are well tolerated. Among people with arthritis, there is no evidence for a benefit to avoid dairy consumption. Dairy products do not increase the risk of cardiovascular disease, particularly if low fat. Intake of up to three servings of dairy products per day appears to be safe and may confer a favourable benefit with regard to bone health.

  2. Effects of Dairy Products Consumption on Health: Benefits and Beliefs--A Commentary from the Belgian Bone Club and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.

    PubMed

    Rozenberg, Serge; Body, Jean-Jacques; Bruyère, Olivier; Bergmann, Pierre; Brandi, Maria Luisa; Cooper, Cyrus; Devogelaer, Jean-Pierre; Gielen, Evelien; Goemaere, Stefan; Kaufman, Jean-Marc; Rizzoli, René; Reginster, Jean-Yves

    2016-01-01

    Dairy products provide a package of essential nutrients that is difficult to obtain in low-dairy or dairy-free diets, and for many people it is not possible to achieve recommended daily calcium intakes with a dairy-free diet. Despite the established benefits for bone health, some people avoid dairy in their diet due to beliefs that dairy may be detrimental to health, especially in those with weight management issues, lactose intolerance, osteoarthritis, rheumatoid arthritis, or trying to avoid cardiovascular disease. This review provides information for health professionals to enable them to help their patients make informed decisions about consuming dairy products as part of a balanced diet. There may be a weak association between dairy consumption and a possible small weight reduction, with decreases in fat mass and waist circumference and increases in lean body mass. Lactose intolerant individuals may not need to completely eliminate dairy products from their diet, as both yogurt and hard cheese are well tolerated. Among people with arthritis, there is no evidence for a benefit to avoid dairy consumption. Dairy products do not increase the risk of cardiovascular disease, particularly if low fat. Intake of up to three servings of dairy products per day appears to be safe and may confer a favourable benefit with regard to bone health. PMID:26445771

  3. 7 CFR 958.90 - Additional parties.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Additional parties. 958.90 Section 958.90 Agriculture... Additional parties. After the effective date hereof, any handler may become a party to this agreement if a... contracting party at the time such counterpart is delivered to the Secretary, and the benefits,...

  4. 7 CFR 958.90 - Additional parties.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Additional parties. 958.90 Section 958.90 Agriculture... Additional parties. After the effective date hereof, any handler may become a party to this agreement if a... contracting party at the time such counterpart is delivered to the Secretary, and the benefits,...

  5. University Benefits Survey. Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Results of a 1984 survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: questions on general benefits, such as insurance plans, communication of benefits, proposed changes in benefits, provision of life and dismemberment insurance, and maternity leave policy;…

  6. University Benefits Survey: Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Information on all benefits, excluding pensions, provided by 16 Ontario universities is presented. The following general questions concerning benefits are covered: administration and insurance plans, communication of benefit programs to employees, proposed changes in benefits, provision of life and dismemberment insurance, and maternity leave…

  7. Closing the Gap between Knowledge and Clinical Application: Challenges for Genomic Translation

    PubMed Central

    Burke, Wylie; Korngiebel, Diane M.

    2015-01-01

    Despite early predictions and rapid progress in research, the introduction of personal genomics into clinical practice has been slow. Several factors contribute to this translational gap between knowledge and clinical application. The evidence available to support genetic test use is often limited, and implementation of new testing programs can be challenging. In addition, the heterogeneity of genomic risk information points to the need for strategies to select and deliver the information most appropriate for particular clinical needs. Accomplishing these tasks also requires recognition that some expectations for personal genomics are unrealistic, notably expectations concerning the clinical utility of genomic risk assessment for common complex diseases. Efforts are needed to improve the body of evidence addressing clinical outcomes for genomics, apply implementation science to personal genomics, and develop realistic goals for genomic risk assessment. In addition, translational research should emphasize the broader benefits of genomic knowledge, including applications of genomic research that provide clinical benefit outside the context of personal genomic risk. PMID:25719903

  8. Closing the gap between knowledge and clinical application: challenges for genomic translation.

    PubMed

    Burke, Wylie; Korngiebel, Diane M

    2015-01-01

    Despite early predictions and rapid progress in research, the introduction of personal genomics into clinical practice has been slow. Several factors contribute to this translational gap between knowledge and clinical application. The evidence available to support genetic test use is often limited, and implementation of new testing programs can be challenging. In addition, the heterogeneity of genomic risk information points to the need for strategies to select and deliver the information most appropriate for particular clinical needs. Accomplishing these tasks also requires recognition that some expectations for personal genomics are unrealistic, notably expectations concerning the clinical utility of genomic risk assessment for common complex diseases. Efforts are needed to improve the body of evidence addressing clinical outcomes for genomics, apply implementation science to personal genomics, and develop realistic goals for genomic risk assessment. In addition, translational research should emphasize the broader benefits of genomic knowledge, including applications of genomic research that provide clinical benefit outside the context of personal genomic risk.

  9. A national evaluation of specialists' clinics in primary care settings.

    PubMed Central

    Bowling, A; Bond, M

    2001-01-01

    clinics, NHS costs were more expensive per patient in outreach. The benefits of outreach clinics on patients' health status at six months' follow-up were relatively small. CONCLUSIONS: Outreach clinics are a means of improving access to specialist services for patients, in addition to improving the efficiency and quality of health care. Most results were similar across specialties and areas. The benefits of the outreach service need to be weighed against their substantially higher NHS costs, in comparison with outpatients clinics. Outreach clinics are unlikely to be financially justifiable for NHS funding given that the impact on patients' health status was small. PMID:11458477

  10. Pharmacogenetics in clinical pediatrics: challenges and strategies

    PubMed Central

    Van Driest, Sara L; McGregor, Tracy L

    2013-01-01

    The use of genetic information to guide medication decisions holds great promise to improve therapeutic outcomes through increased efficacy and reduced adverse events. As in many areas of medicine, pediatric research and clinical implementation in pharmacogenetics lag behind corresponding adult discovery and clinical applications. In adults, genotype-guided clinical decision support for medications such as clopidogrel, warfarin and simvastatin are in use in some medical centers. However, research conducted in pediatric populations demonstrates that the models and practices developed in adults may be inaccurate in children, and some applications lack any pediatric research to guide clinical decisions. To account for additional factors introduced by developmental considerations in pediatric populations and provide pediatric patients with maximal benefit from genotype-guided therapy, the field will need to develop and employ creative solutions. In this article, we detail some concerns about research and clinical implementation of pharmacogenetics in pediatrics, and present potential mechanisms for addressing them. PMID:24363766

  11. Integration of risk and benefit analysis-the window of benefit as a new tool?

    PubMed

    Palou, Andreu; Pico, Catalina; Keijer, Jaap

    2009-08-01

    Foods and food components can have positive and/or negative effects on our health, resulting in benefits and risks. At present these are evaluated in largely separated trajectories. In view of assessment, management, and communication, we here propose and argue for an integrated evaluation of risk and benefit of food components and foods. The window of benefit assessment concept is described as a framework to combine thresholds and scores. The recommended dietary allowance (RDA) and the tolerable upper intake level (UL) delimit the range of intakes that should be considered sufficient to prevent deficiency, while avoiding toxicity. Within these thresholds, two additional thresholds, the lower and upper level of additional benefit (LLAB and ULAB), define the range of intakes that constitute an additional benefit. Intake within these limits should thus be protective against a specified health or nutritional risk of public health relevance. To faithfully predict outcomes and to obtain the tools that are necessary to support scientific valid evaluations, a mechanism based systems biology understanding of the effects of foods and nutrients is seen as the way forward. Ultimately this should lead to an integrated risk-benefit assessment, which will allow better management and, especially, communication, to the benefit of the consumer.

  12. Cost benefit analysis of bovine mastitis in the UK.

    PubMed

    Beck, H S; Wise, W S; Dodd, F H

    1992-11-01

    Bovine mastitis reduces the yield and quality of milk and increases the rate of culling and veterinary costs. This reduces the profitability of farm milk production but the calculation of the extent of this economic loss is complex because of the many factors involved and deficiencies in the evidence on the relationship between the disease and various production factors. This paper examines the available evidence for the UK and provides a consistent analytical framework within which the benefits arising from reduced mastitis in dairy herds constrained by quota can be considered. It is estimated that since 1970 the farms that have followed the recommended control procedures have reduced the average annual number of cases of clinical mastitis from 135 to 40 cases/100 cows each year, while the quarters remaining uninfected for a whole year has increased from 65 to 80% of the total quarters. The costs of the main control procedures (e.g. 8.60 pounds/cow for dry-cow therapy and teat dipping or spraying) are broadly covered by the reduction in clinical mastitis, leaving the benefits of reduced subclinical infection (e.g. 3810 pounds for a 100 cow herd unconstrained by quota and achieving the average reduction in infection) as a substantial bonus. The imposition of quotas reduces the financial benefit of mastitis control but it still remains a worthwhile investment. The results of this analysis can be used to suggest maximum costs of additional new control measures produced by research. It also indicates that there is considerable value in production research which gives more precise knowledge of production systems, thus allowing producers to respond optimally to quota cuts.

  13. Spotlight on lasers. A look at potential benefits

    SciTech Connect

    Zakariasen, K.L.; MacDonald, R.; Boran, T. )

    1991-07-01

    Before lasers can be highly integrated into clinical practice, further research must prove the efficacy, efficiency, consistency and safety of this new technology. Currently, increased caries prevention and rapid laser etching are two potential benefits of laser technology.

  14. Amendments to excepted benefits. Final rules.

    PubMed

    2014-10-01

    This document contains final regulations that amend the regulations regarding excepted benefits under the Employee Retirement Income Security Act of 1974, the Internal Revenue Code (the Code), and the Public Health Service Act. Excepted benefits are generally exempt from the health reform requirements that were added to those laws by the Health Insurance Portability and Accountability Act and the Patient Protection and Affordable Care Act. In addition, eligibility for excepted benefits does not preclude an individual from eligibility for a premium tax credit under section 36B of the Code if an individual chooses to enroll in coverage under a Qualified Health Plan through an Affordable Insurance Exchange. These regulations finalize some but not all of the proposed rules with minor modifications; additional guidance on limited wraparound coverage is forthcoming.

  15. Amendments to excepted benefits. Final rules.

    PubMed

    2014-10-01

    This document contains final regulations that amend the regulations regarding excepted benefits under the Employee Retirement Income Security Act of 1974, the Internal Revenue Code (the Code), and the Public Health Service Act. Excepted benefits are generally exempt from the health reform requirements that were added to those laws by the Health Insurance Portability and Accountability Act and the Patient Protection and Affordable Care Act. In addition, eligibility for excepted benefits does not preclude an individual from eligibility for a premium tax credit under section 36B of the Code if an individual chooses to enroll in coverage under a Qualified Health Plan through an Affordable Insurance Exchange. These regulations finalize some but not all of the proposed rules with minor modifications; additional guidance on limited wraparound coverage is forthcoming. PMID:25341261

  16. Would banning atrazine benefit farmers?

    PubMed Central

    Ackerman, Frank; Whited, Melissa; Knight, Patrick

    2014-01-01

    Atrazine, an herbicide used on most of the US corn (maize) crop, is the subject of ongoing controversy, with increasing documentation of its potentially harmful health and environmental impacts. Supporters of atrazine often claim that it is of great value to farmers; most recently, Syngenta, the producer of atrazine, sponsored an “Atrazine Benefits Team” (ABT) of researchers who released a set of five papers in 2011, reporting huge economic benefits from atrazine use in US agriculture. A critical review of the ABT papers shows that they have underestimated the growing problem of atrazine-resistant weeds, offered only a partial review of the effectiveness of alternative herbicides, and ignored the promising option of non-chemical weed management techniques. In addition, the most complete economic analysis in the ABT papers implies that withdrawal of atrazine would lead to a decrease in corn yields of 4.4% and an increase in corn prices of 8.0%. The result would be an increase in corn growers’ revenues, equal to US$1.7 billion annually under ABT assumptions. Price impacts on consumers would be minimal: at current levels of ethanol production and use, gasoline prices would rise by no more than US$0.03 per gallon; beef prices would rise by an estimated US$0.01 for a 4-ounce hamburger and US$0.05 for an 8-ounce steak. Thus withdrawal of atrazine would boost farm revenues, while only changing consumer prices by pennies. PMID:24804340

  17. Space exercise and Earth benefits.

    PubMed

    Macias, Brandon R; Groppo, Eli R; Eastlack, Robert K; Watenpaugh, Donald E; Lee, Stuart M C; Schneider, Suzanne M; Boda, Wanda L; Smith, Scott M; Cutuk, Adnan; Pedowitz, Robert A; Meyer, R Scott; Hargens, Alan R

    2005-08-01

    The detrimental impact of long duration space flight on physiological systems necessitates the development of exercise countermeasures to protect work capabilities in gravity fields of Earth, Moon and Mars. The respective rates of physiological deconditioning for different organ systems during space flight has been described as a result of data collected during and after missions on the Space Shuttle, International Space Station, Mir, and bed rest studies on Earth. An integrated countermeasure that simulates the body's hydrostatic pressure gradient, provides mechanical stress to the bones and muscles, and stimulates the neurovestibular system may be critical for maintaining health and well being of crew during long-duration space travel, such as a mission to Mars. Here we review the results of our studies to date of an integrated exercise countermeasure for space flight, lower body negative pressure (LBNP) treadmill exercise, and potential benefits of its application to athletic training on Earth. Additionally, we review the benefits of Lower Body Positive Pressure (LBPP) exercise for rehabilitation of postoperative patients. Presented first are preliminary data from a 30-day bed rest study evaluating the efficacy of LBNP exercise as an integrated exercise countermeasure for the deconditioning effects of microgravity. Next, we review upright LBNP exercise as a training modality for athletes by evaluating effects on the cardiovascular system and gait mechanics. Finally, LBPP exercise as a rehabilitation device is examined with reference to gait mechanics and safety in two groups of postoperative patients.

  18. Would banning atrazine benefit farmers?

    PubMed

    Ackerman, Frank; Whited, Melissa; Knight, Patrick

    2014-01-01

    Atrazine, an herbicide used on most of the US corn (maize) crop, is the subject of ongoing controversy, with increasing documentation of its potentially harmful health and environmental impacts. Supporters of atrazine often claim that it is of great value to farmers; most recently, Syngenta, the producer of atrazine, sponsored an "Atrazine Benefits Team" (ABT) of researchers who released a set of five papers in 2011, reporting huge economic benefits from atrazine use in US agriculture. A critical review of the ABT papers shows that they have underestimated the growing problem of atrazine-resistant weeds, offered only a partial review of the effectiveness of alternative herbicides, and ignored the promising option of nonchemical weed management techniques. In addition, the most complete economic analysis in the ABT papers implies that withdrawal of atrazine would lead to a decrease in corn yields of 4.4% and an increase in corn prices of 8.0%. The result would be an increase in corn growers' revenues, equal to US$1.7 billion annually under ABT assumptions. Price impacts on consumers would be minimal: at current levels of ethanol production and use, gasoline prices would rise by no more than US$0.03 per gallon; beef prices would rise by an estimated US$0.01 for a 4-ounce hamburger and US$0.05 for an 8-ounce steak. Thus withdrawal of atrazine would boost farm revenues, while only changing consumer prices by pennies.

  19. [INVITED] Lasers in additive manufacturing

    NASA Astrophysics Data System (ADS)

    Pinkerton, Andrew J.

    2016-04-01

    Additive manufacturing is a topic of considerable ongoing interest, with forecasts predicting it to have major impact on industry in the future. This paper focusses on the current status and potential future development of the technology, with particular reference to the role of lasers within it. It begins by making clear the types and roles of lasers in the different categories of additive manufacturing. This is followed by concise reviews of the economic benefits and disadvantages of the technology, current state of the market and use of additive manufacturing in different industries. Details of these fields are referenced rather than expanded in detail. The paper continues, focusing on current indicators to the future of additive manufacturing. Barriers to its development, trends and opportunities in major industrial sectors, and wider opportunities for its development are covered. Evidence indicates that additive manufacturing may not become the dominant manufacturing technology in all industries, but represents an excellent opportunity for lasers to increase their influence in manufacturing as a whole.

  20. Sustainable Facility Development: Perceived Benefits and Challenges

    ERIC Educational Resources Information Center

    Stinnett, Brad; Gibson, Fred

    2016-01-01

    Purpose: The purpose of this paper is to assess the perceived benefits and challenges of implementing sustainable initiatives in collegiate recreational sports facilities. Additionally, this paper intends to contribute to the evolving field of facility sustainability in higher education. Design/methodology/approach The design included qualitative…

  1. 7 CFR 783.8 - Multiple benefits.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... loans or payments resulting from purchase of the additional coverage insurance, as defined in 7 CFR 400... SPECIAL PROGRAMS TREE ASSISTANCE PROGRAM § 783.8 Multiple benefits. Persons may not receive or retain payments for production losses from trees, vines and bushes under this part if they have been...

  2. Learn about Clinical Studies

    MedlinePlus

    ... in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions. Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. ...

  3. Green tea and theanine: health benefits.

    PubMed

    Cooper, Raymond

    2012-03-01

    Historically, the medicinal use of green tea dates back to China 4700 years ago and drinking tea continues to be regarded traditionally in Asia as a general healthful practice. Numerous scientific publications now attest to the health benefits of both black and green teas, including clinical and epidemiological studies. Although all tea contains beneficial antioxidants, high-quality green and white teas have them in greater concentrations than black tea. Today, scientists believe that the main active ingredients of green tea include the polyphenols, in particular the catechins and the amino acid, theanine. Studies on the health benefits of drinking tea, particularly green tea, are finding exciting results, particularly in cancer research. Modern studies in both Asia and the West have provided encouraging results indicating that drinking green tea contributes to fighting many different kinds of cancers including stomach, oesophageal, ovarian and colon. Recent studies describing the health benefits of these compounds will be reviewed.

  4. The benefit of forgetting.

    PubMed

    Williams, Melonie; Hong, Sang W; Kang, Min-Suk; Carlisle, Nancy B; Woodman, Geoffrey F

    2013-04-01

    Recent research using change-detection tasks has shown that a directed-forgetting cue, indicating that a subset of the information stored in memory can be forgotten, significantly benefits the other information stored in visual working memory. How do these directed-forgetting cues aid the memory representations that are retained? We addressed this question in the present study by using a recall paradigm to measure the nature of the retained memory representations. Our results demonstrated that a directed-forgetting cue leads to higher-fidelity representations of the remaining items and a lower probability of dropping these representations from memory. Next, we showed that this is made possible by the to-be-forgotten item being expelled from visual working memory following the cue, allowing maintenance mechanisms to be focused on only the items that remain in visual working memory. Thus, the present findings show that cues to forget benefit the remaining information in visual working memory by fundamentally improving their quality relative to conditions in which just as many items are encoded but no cue is provided. PMID:23208769

  5. Variation of employee benefit costs by age.

    PubMed

    Rappaport, A

    2000-01-01

    Health care, pension, and disability plans account for the bulk of employers' benefit costs, as defined in this article. Because those costs tend to rise as employees get older, the age structure of the workforce affects not only employers' costs but ultimately their competitiveness in global markets. How much costs vary depends in large part on the structure of the benefits package provided. The method a company chooses to finance benefits generally varies with its size. This article focuses primarily on the benefit practices of large, private employers. In the long run, such employers pay the costs associated with the demographics of their workers, whereas small employers can often pool costs with other companies in the community. In addition, small employers often offer fewer benefits, and the costs and financing of those benefits are subject to the insurance markets and state regulations. The discussion of benefit packages is illustrated by case studies based on benefits that are typical for three types of organizations--a large traditional company such as steel, automobile, and manufacturing; a large financial services company such as a bank or health care organization; and a medium-sized retail organization. The case studies demonstrate the extent to which the costs of typical packages vary and reveal that employers differ radically in the incentives they offer employees to retire at a specific time. An employer can shift the variation in cost by age by changing the structure of the benefit program. The major forces that drive age differences in benefit costs are the time value of money (the period of time available to earn investment income and the operation of compound interest) and rates of health care use, disability, and death. Those forces apply universally, in the United States and elsewhere, and they have not changed in recent years. However, the marketplace and the prevalence of various types of benefit programs have changed, and those changes have

  6. 20 CFR 410.633 - Additional parties to the hearing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Additional parties to the hearing. 410.633 Section 410.633 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT..., Administrative Review, Finality of Decisions, and Representation of Parties § 410.633 Additional parties to...

  7. 20 CFR 410.633 - Additional parties to the hearing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Additional parties to the hearing. 410.633 Section 410.633 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT..., Administrative Review, Finality of Decisions, and Representation of Parties § 410.633 Additional parties to...

  8. Defective mismatch repair and benefit from bevacizumab for colon cancer: findings from NSABP C-08.

    PubMed

    Pogue-Geile, Kay; Yothers, Greg; Taniyama, Yusuke; Tanaka, Noriko; Gavin, Patrick; Colangelo, Linda; Blackmon, Nicole; Lipchik, Corey; Kim, Seong Rim; Sharif, Saima; Allegra, Carmen; Petrelli, Nicholas; O'Connell, Michael J; Wolmark, Norman; Paik, Soonmyung

    2013-07-01

    National Surgical Adjuvant Breast and Bowel Project protocol C-08 tested the worth of adding 1 year of bevacizumab to oxaliplatin-based standard adjuvant chemotherapy regimen in the treatment of stage II/III colon cancer. Although the overall result was negative, the possibility that a molecularly defined subset could benefit from bevacizumab cannot be ruled out. We performed post hoc Cox regression analyses to test for marker-by-treatment interactions for standard pathological features and survival analyses using the Kaplan-Meier method. All statistical tests were two-sided and considered statistically significant at the .05 level. Patients diagnosed with mismatch repair defective (dMMR) tumors derived statistically significant survival benefit from the addition of bevacizumab (hazard ratio [HR] = 0.52; 95% confidence interval [CI] = 0.29 to 0.94; P = .02) in contrast with no benefit in patients diagnosed with mismatch repair proficient tumors (HR = 1.03; 95% CI = 0.84 to 1.27; p = .78; P(interaction)= .04). Although a post hoc finding, this data suggests that a molecularly defined subset of colon cancer patients may derive clinical benefit from antiangiogenesis agents and underscores the need for independent validation in other clinical trials.

  9. Defective Mismatch Repair and Benefit from Bevacizumab for Colon Cancer: Findings from NSABP C-08

    PubMed Central

    2013-01-01

    National Surgical Adjuvant Breast and Bowel Project protocol C-08 tested the worth of adding 1 year of bevacizumab to oxaliplatin-based standard adjuvant chemotherapy regimen in the treatment of stage II/III colon cancer. Although the overall result was negative, the possibility that a molecularly defined subset could benefit from bevacizumab cannot be ruled out. We performed post hoc Cox regression analyses to test for marker-by-treatment interactions for standard pathological features and survival analyses using the Kaplan–Meier method. All statistical tests were two-sided and considered statistically significant at the .05 level. Patients diagnosed with mismatch repair defective (dMMR) tumors derived statistically significant survival benefit from the addition of bevacizumab (hazard ratio [HR] = 0.52; 95% confidence interval [CI] = 0.29 to 0.94; P = .02) in contrast with no benefit in patients diagnosed with mismatch repair proficient tumors (HR = 1.03; 95% CI = 0.84 to 1.27; p = .78; P interaction = .04). Although a post hoc finding, this data suggests that a molecularly defined subset of colon cancer patients may derive clinical benefit from antiangiogenesis agents and underscores the need for independent validation in other clinical trials. PMID:23821759

  10. Clinical management of neurocysticercosis.

    PubMed

    Del Brutto, Oscar H

    2014-04-01

    Neurocysticercosis is the most common helminthic disease of the nervous system and a leading cause of acquired epilepsy worldwide. Differences in the number and location of lesions as well as in the severity of the immune response against the parasites, makes neurocysticercosis a complex disease. Therefore, a single therapeutic approach is not expected to be useful in every patient. Introduction of cysticidal drugs - praziquantel and albendazole - have changed the prognosis of thousands of patients with neurocysticercosis. While pioneer trials of therapy were flawed by a poor design, recent studies have shown that cysticidal drugs results in disappearance of lesions and clinical improvement in most cases. Nevertheless, some patients with parenchymal neurocysticercosis may be left with remaining cysts and may develop recurrent seizures after therapy, and many patients with subarachnoid cysts may need repeated courses of therapy. In addition, not all forms of the disease benefit from cysticidal drugs.

  11. University Benefits Survey. Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Results of a 1985 survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: whether the university self-administers insurance plans, communication of information on benefits, proposed changes in benefits, provision of accidental death and dismemberment insurance,…

  12. University Benefits Survey. Part 1 (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Results of a 1983 survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: whether the university self-administers insurance plans, communication of benefits, proposed changes in benefits, provision of life and dismemberment insurance, maternity leave policy,…

  13. University Benefits Survey, Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    The results of a survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: whether the university self-administers insurance plans, communication of benefits, proposed changes in benefits, provision of life and dismemberment insurance, maternity leave policy, Ontario…

  14. University Benefits Survey. Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Results of a 1986 survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: whether the university self- administers insurance plans, communication of benefits, proposed changes in benefits, provision of accidental death and dismemberment insurance, maternity leave…

  15. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-05-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  16. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-04-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error, or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilized due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices [EUDAMED]) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to "predicate" products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  17. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-04-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error, or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilized due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices [EUDAMED]) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to "predicate" products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  18. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-05-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  19. Hurricanes benefit bleached corals

    PubMed Central

    Manzello, Derek P.; Brandt, Marilyn; Smith, Tyler B.; Lirman, Diego; Hendee, James C.; Nemeth, Richard S.

    2007-01-01

    Recent, global mass-mortalities of reef corals due to record warm sea temperatures have led researchers to consider global warming as one of the most significant threats to the persistence of coral reef ecosystems. The passage of a hurricane can alleviate thermal stress on coral reefs, highlighting the potential for hurricane-associated cooling to mitigate climate change impacts. We provide evidence that hurricane-induced cooling was responsible for the documented differences in the extent and recovery time of coral bleaching between the Florida Reef Tract and the U.S. Virgin Islands during the Caribbean-wide 2005 bleaching event. These results are the only known scenario where the effects of a hurricane can benefit a stressed marine community. PMID:17606914

  20. Hurricanes benefit bleached corals.

    PubMed

    Manzello, Derek P; Brandt, Marilyn; Smith, Tyler B; Lirman, Diego; Hendee, James C; Nemeth, Richard S

    2007-07-17

    Recent, global mass-mortalities of reef corals due to record warm sea temperatures have led researchers to consider global warming as one of the most significant threats to the persistence of coral reef ecosystems. The passage of a hurricane can alleviate thermal stress on coral reefs, highlighting the potential for hurricane-associated cooling to mitigate climate change impacts. We provide evidence that hurricane-induced cooling was responsible for the documented differences in the extent and recovery time of coral bleaching between the Florida Reef Tract and the U.S. Virgin Islands during the Caribbean-wide 2005 bleaching event. These results are the only known scenario where the effects of a hurricane can benefit a stressed marine community.

  1. Atomic bomb health benefits.

    PubMed

    Luckey, T D

    2008-01-01

    Media reports of deaths and devastation produced by atomic bombs convinced people around the world that all ionizing radiation is harmful. This concentrated attention on fear of miniscule doses of radiation. Soon the linear no threshold (LNT) paradigm was converted into laws. Scientifically valid information about the health benefits from low dose irradiation was ignored. Here are studies which show increased health in Japanese survivors of atomic bombs. Parameters include decreased mutation, leukemia and solid tissue cancer mortality rates, and increased average lifespan. Each study exhibits a threshold that repudiates the LNT dogma. The average threshold for acute exposures to atomic bombs is about 100 cSv. Conclusions from these studies of atomic bomb survivors are: One burst of low dose irradiation elicits a lifetime of improved health.Improved health from low dose irradiation negates the LNT paradigm.Effective triage should include radiation hormesis for survivor treatment.

  2. NASA Technology Benefits Orthotics

    NASA Technical Reports Server (NTRS)

    Myers, Neill; Shadoan, Michael

    1998-01-01

    Engineers at NASA's Marshall Space Flight Center (MSFC) in Huntsville, Alabama have designed a knee brace to aid in the rehabilitation of medical patients. The device, called the Selectively Lockable Knee Brace, was designed for knee injury and stroke patients but may potentially serve in many more patient applications. Individuals with sports related injuries, spinal cord injuries and birth defects, such as spina bifida, may also benefit from the device. The Selectively Lockable Knee Brace is designed to provide secure support to the patient when weight is applied to the leg; however; when the leg is not supporting weight, the device allows free motion of the knee joint. Braces currently on the market lock the knee in a rigid, straight or bent position, or by manually pulling a pin, allow continuous free joint motion.

  3. NASA Benefits Earth

    NASA Technical Reports Server (NTRS)

    Robinson, Julie A.

    2009-01-01

    This slide presentation reviews several ways in which NASA research has benefited Earth and made life on Earth better. These innovations include: solar panels, recycled pavement, thermometer pill, invisible braces for straightening teeth, LASIK, aerodynamic helmets and tires for bicycles, cataract detection, technology that was used to remove Anthrax spores from mail handling facilities, study of atomic oxygen erosion of materials has informed the restoration of artwork, macroencapsulation (a potential mechanism to deliver anti cancer drugs to specific sites), and research on a salmonella vaccine. With research on the International Space Station just beginning, there will be opportunities for entrepreneurs and other government agencies to access space for their research and development. As well as NASA continuing its own research on human health and technology development.

  4. [Food additives and healthiness].

    PubMed

    Heinonen, Marina

    2014-01-01

    Additives are used for improving food structure or preventing its spoilage, for example. Many substances used as additives are also naturally present in food. The safety of additives is evaluated according to commonly agreed principles. If high concentrations of an additive cause adverse health effects for humans, a limit of acceptable daily intake (ADI) is set for it. An additive is a risk only when ADI is exceeded. The healthiness of food is measured on the basis of nutrient density and scientifically proven effects.

  5. Rationalizing Prescribing for Older Patients with Multimorbidity: Considering Time to Benefit

    PubMed Central

    Holmes, Holly M.; Min, Lillian C.; Yee, Michael; Varadhan, Ravi; Basran, Jenny; Dale, William; Boyd, Cynthia M.

    2013-01-01

    Given the growing number of older adults with multimorbidity who are prescribed multiple medications, clinicians need to prioritize which medications are most likely to benefit and least likely to harm an individual patient. The concept of time to benefit (TTB) is increasingly discussed in addition to other measures of drug effectiveness in order to understand and contextualize the benefits and harms of a therapy to an individual patient. However, how to glean this information from available evidence is not well established. The lack of such information for clinicians highlights a critical need in the design and reporting of clinical trials to provide information most relevant to decision making for older adults with multimorbidity. We define TTB as the time until a statistically significant benefit is observed in trials of people taking a therapy compared to a control group not taking the therapy. Similarly, time to harm (TTH) is the time until a significantly significant adverse effect is seen in a trial for the treatment group compared to the control group. To determine both TTB and TTH, it is critical that we also clearly define the benefit or harm under consideration. Well-defined benefits or harms are clinically meaningful, measurable outcomes that are desired (or shunned) by patients. In this conceptual review, we illustrate concepts of TTB in randomized controlled trials (RCTs) of statins for the primary prevention of cardiovascular disease. Using published results, we estimate probable TTB for statins with the future goal of using such information to improve prescribing decisions for individual patients. Knowing the relative TTBs and TTHs associated with a patient’s medications could be immensely useful to a clinician in decision-making for their older patients with multimorbidity. We describe the challenges in defining and determining TTB and TTH, and discuss possible ways for analyzing and reporting trial results which would add more information about

  6. Benefit Plans in Higher Education.

    ERIC Educational Resources Information Center

    King, Francis P.; Cook, Thomas J.

    Fifth in a series and the latest of several studies on employee benefits in higher education, this book constitutes a full-scale revision of the earlier "Benefit Plans in American Colleges" (1969). The principal benefit plans provided by U.S. colleges and universities are described, analyzed, and evaluated. Included are retirement (including…

  7. Benefit Plans in Junior Colleges.

    ERIC Educational Resources Information Center

    King, Francis P.

    This study describes the present status of benefit planning in the junior colleges, discusses the principles governing benefit plans, and raises questions regarding the development of sound benefit plans in light of the needs of individual faculty and staff as well as of the goals of the institution. The base of the study was a questionnaire…

  8. Analysis of the Community Benefit Standard in Texas Hospitals.

    PubMed

    Worthy, James Corbett; Anderson, Cheryl L

    2016-01-01

    The federal government provides special tax-exemption status, known as the community benefit standard, to some nonprofit hospitals. It is not known if hospitals that claim the community benefit standard provide more or different services from those provided by hospitals that do not claim the community benefit status. Guided by the socioecological model, this quantitative study investigated 95 hospitals serving 52 counties in South Texas--43 that claimed a community benefit and 52 that did not. The independent variables were hospitals that claimed the community benefit standard versus hospitals that did not. The dependent variables were the three essential criteria and the 13 reported services used to meet the community benefit standard. The study results show that all hospitals that claimed the community benefit standard met two of the three required criteria. However, only 22 of 43 hospitals had a full-time emergency department (ED), the third criterion. Χ² analysis showed statistically significant differences for only two of the five common services: having an ED and community education for community benefit hospitals versus noncommunity benefit hospitals. On average, hospitals that claimed the community benefit spent 100 times more money on community services than hospitals that did not claim the community benefit. Further investigation is needed to determine the reasons for the gap in services pertaining to EDs, trauma care, neonatal intensive care, free-standing clinics, collaborative efforts, other medical services, education of patients, community health education, and other education services. PMID:27111928

  9. Analysis of the Community Benefit Standard in Texas Hospitals.

    PubMed

    Worthy, James Corbett; Anderson, Cheryl L

    2016-01-01

    The federal government provides special tax-exemption status, known as the community benefit standard, to some nonprofit hospitals. It is not known if hospitals that claim the community benefit standard provide more or different services from those provided by hospitals that do not claim the community benefit status. Guided by the socioecological model, this quantitative study investigated 95 hospitals serving 52 counties in South Texas--43 that claimed a community benefit and 52 that did not. The independent variables were hospitals that claimed the community benefit standard versus hospitals that did not. The dependent variables were the three essential criteria and the 13 reported services used to meet the community benefit standard. The study results show that all hospitals that claimed the community benefit standard met two of the three required criteria. However, only 22 of 43 hospitals had a full-time emergency department (ED), the third criterion. Χ² analysis showed statistically significant differences for only two of the five common services: having an ED and community education for community benefit hospitals versus noncommunity benefit hospitals. On average, hospitals that claimed the community benefit spent 100 times more money on community services than hospitals that did not claim the community benefit. Further investigation is needed to determine the reasons for the gap in services pertaining to EDs, trauma care, neonatal intensive care, free-standing clinics, collaborative efforts, other medical services, education of patients, community health education, and other education services.

  10. Clinical research: what do patients understand?

    PubMed

    Erlen, J A

    2000-01-01

    An increasing amount of clinical research is being conducted to test the efficacy and effectiveness of new medications, therapies, and medical procedures. These studies often require that patients be invited to be subjects. However, what do patients really understand whenever they are asked to participate in clinical research? Are patients aware that research is clearly different from treatment? Are they aware that their participation in research is to benefit future patients? Despite the desire of clinical agencies to support research, there is the concern about how they can best protect the rights of patients who are subjects in this research. The author briefly discusses clinical research, patients as vulnerable subjects, the therapeutic misconception, and informed consent. In addition, recommendations are provided to help assure that the rights of patients who are research subjects are protected.

  11. Esophageal Impedance Monitoring: Clinical Pearls and Pitfalls.

    PubMed

    Ravi, Karthik; Katzka, David A

    2016-09-01

    The development of intraluminal esophageal impedance monitoring has improved our ability to detect and measure gastroesophageal reflux without dependence on acid content. This ability to detect previously unrecognized weak or nonacid reflux episodes has had important clinical implications in the diagnosis and management of gastroesophageal reflux disease (GERD). In addition, with the ability to assess bolus transit within the esophageal lumen, impedance monitoring has enhanced the recognition and characterization of esophageal motility disorders in patients with nonobstructive dysphagia. The assessment of the intraluminal movement of gas and liquid has also been proven to be of diagnostic value in conditions such as rumination syndrome and excessive belching. Further, alternative applications of impedance monitoring, such as the measurement of mucosal impedance, have provided novel insights into assessing esophageal mucosal integrity changes as a consequence of inflammatory change. Future applications for esophageal impedance monitoring also hold promise in esophageal conditions other than GERD. However, despite all of the clinical benefits afforded by esophageal impedance monitoring, important clinical and technical shortcomings limit its diagnostic value and must be considered when interpreting study results. Overinterpretation of studies or application of impedance monitoring in patients can have deleterious clinical implications. This review will highlight the clinical benefits and limitations of esophageal impedance monitoring and provide clinical pearls and pitfalls associated with this technology.

  12. Esophageal Impedance Monitoring: Clinical Pearls and Pitfalls.

    PubMed

    Ravi, Karthik; Katzka, David A

    2016-09-01

    The development of intraluminal esophageal impedance monitoring has improved our ability to detect and measure gastroesophageal reflux without dependence on acid content. This ability to detect previously unrecognized weak or nonacid reflux episodes has had important clinical implications in the diagnosis and management of gastroesophageal reflux disease (GERD). In addition, with the ability to assess bolus transit within the esophageal lumen, impedance monitoring has enhanced the recognition and characterization of esophageal motility disorders in patients with nonobstructive dysphagia. The assessment of the intraluminal movement of gas and liquid has also been proven to be of diagnostic value in conditions such as rumination syndrome and excessive belching. Further, alternative applications of impedance monitoring, such as the measurement of mucosal impedance, have provided novel insights into assessing esophageal mucosal integrity changes as a consequence of inflammatory change. Future applications for esophageal impedance monitoring also hold promise in esophageal conditions other than GERD. However, despite all of the clinical benefits afforded by esophageal impedance monitoring, important clinical and technical shortcomings limit its diagnostic value and must be considered when interpreting study results. Overinterpretation of studies or application of impedance monitoring in patients can have deleterious clinical implications. This review will highlight the clinical benefits and limitations of esophageal impedance monitoring and provide clinical pearls and pitfalls associated with this technology. PMID:27325223

  13. Health Benefits of Nut Consumption

    PubMed Central

    Ros, Emilio

    2010-01-01

    Nuts (tree nuts and peanuts) are nutrient dense foods with complex matrices rich in unsaturated fatty and other bioactive compounds: high-quality vegetable protein, fiber, minerals, tocopherols, phytosterols, and phenolic compounds. By virtue of their unique composition, nuts are likely to beneficially impact health outcomes. Epidemiologic studies have associated nut consumption with a reduced incidence of coronary heart disease and gallstones in both genders and diabetes in women. Limited evidence also suggests beneficial effects on hypertension, cancer, and inflammation. Interventional studies consistently show that nut intake has a cholesterol-lowering effect, even in the context of healthy diets, and there is emerging evidence of beneficial effects on oxidative stress, inflammation, and vascular reactivity. Blood pressure, visceral adiposity and the metabolic syndrome also appear to be positively influenced by nut consumption. Thus it is clear that nuts have a beneficial impact on many cardiovascular risk factors. Contrary to expectations, epidemiologic studies and clinical trials suggest that regular nut consumption is unlikely to contribute to obesity and may even help in weight loss. Safety concerns are limited to the infrequent occurrence of nut allergy in children. In conclusion, nuts are nutrient rich foods with wide-ranging cardiovascular and metabolic benefits, which can be readily incorporated into healthy diets. PMID:22254047

  14. Telehealth brings benefits.

    PubMed

    2016-08-01

    A telehealth clinical lead writing in Primary Health Care says that for the NHS to thrive, front line staff and patients must be empowered. New ways of working are needed and the use of technology should be maximised. Telehealth allows nurses to work more efficiently, communicate better with patients and families, and improve health outcomes cost-effectively. The author encourages frontline nurses to implement changes in the work place and suggests NHS Change Day in October as a starting point. The article also notes the importance of social media in opening up opportunities to connect with other nurses. PMID:27484572

  15. Workers compensation: coverage, benefits, and costs, 1982

    SciTech Connect

    Price, D.N.

    1984-12-01

    Workers compensation provides medical care and income maintenance protection to workers disabled from work-related injury or illness. This program is of considerable interest to the Social Security Administration (SSA) from several perspectives. For example, since 1965 Social Security Disability Insurance (DI) benefits and workers compensation payments have been integrated. Information on the experience under workers compensation provides a framework for examining questions concerning gaps and overlaps in the Nation's social insurance system. In addition, since December 1969 SSA has administered claims filed through 1973 under part B of the Black Lung program--the program providing income maintenance protection to coal miners disabled by pneumoconiosis. The workers compensation experience reported here consists of information on benefits for work-related injury and disease, including data on the combined benefits paid under the entire Federal Black Lung program administered by the Labor Department and SSA.

  16. Number Needed to Benefit From Information (NNBI): Proposal From a Mixed Methods Research Study With Practicing Family Physicians

    PubMed Central

    Pluye, Pierre; Grad, Roland M.; Johnson-Lafleur, Janique; Granikov, Vera; Shulha, Michael; Marlow, Bernard; Ricarte, Ivan Luiz Marques

    2013-01-01

    PURPOSE We wanted to describe family physicians’ use of information from an electronic knowledge resource for answering clinical questions, and their perception of subsequent patient health outcomes; and to estimate the number needed to benefit from information (NNBI), defined as the number of patients for whom clinical information was retrieved for 1 to benefit. METHODS We undertook a mixed methods research study, combining quantitative longitudinal and qualitative research studies. Participants were 41 family physicians from primary care clinics across Canada. Physicians were given access to 1 electronic knowledge resource on handheld computer in 2008–2009. For the outcome assessment, participants rated their searches using a validated method. Rated searches were examined during interviews guided by log reports that included ratings. Cases were defined as clearly described searches where clinical information was used for a specific patient. For each case, interviewees described information-related patient health outcomes. For the mixed methods data analysis, quantitative and qualitative data were merged into clinical vignettes (each vignette describing a case). We then estimated the NNBI. RESULTS In 715 of 1,193 searches for information conducted during an average of 86 days, the search objective was directly linked to a patient. Of those searches, 188 were considered to be cases. In 53 cases, participants associated the use of information with at least 1 patient health benefit. This finding suggested an NNBI of 14 (715/53). CONCLUSION The NNBI may be used in further experimental research to compare electronic knowledge resources. A low NNBI can encourage clinicians to search for information more frequently. If all searches had benefits, the NNBI would be 1. In addition to patient benefits, learning and knowledge reinforcement outcomes are frequently reported. PMID:24218380

  17. Health benefits of tennis

    PubMed Central

    Pluim, Babette M; Staal, J Bart; Marks, Bonita L; Miller, Stuart; Miley, Dave

    2007-01-01

    The aim of the study was to explore the role of tennis in the promotion of health and prevention of disease. The focus was on risk factors and diseases related to a sedentary lifestyle, including low fitness levels, obesity, hyperlipidaemia, hypertension, diabetes mellitus, cardiovascular disease, and osteoporosis. A literature search was undertaken to retrieve relevant articles. Structured computer searches of PubMed, Embase, and CINAHL were undertaken, along with hand searching of key journals and reference lists to locate relevant studies published up to March 2007. These had to be cohort studies (of either cross sectional or longitudinal design), case–control studies, or experimental studies. Twenty four studies were identified that dealt with physical fitness of tennis players, including 17 on intensity of play and 16 on maximum oxygen uptake; 17 investigated the relation between tennis and (risk factors for) cardiovascular disease; and 22 examined the effect of tennis on bone health. People who choose to play tennis appear to have significant health benefits, including improved aerobic fitness, a lower body fat percentage, a more favourable lipid profile, reduced risk for developing cardiovascular disease, and improved bone health. PMID:17504788

  18. 45 CFR 148.220 - Excepted benefits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... insurance. These benefits include the following: (1) Limited scope dental or vision benefits. These benefits are dental or vision benefits that are limited in scope to a narrow range or type of benefits that...

  19. 45 CFR 148.220 - Excepted benefits.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... insurance. These benefits include the following: (1) Limited scope dental or vision benefits. These benefits are dental or vision benefits that are limited in scope to a narrow range or type of benefits that...

  20. Separate spheres and indirect benefits

    PubMed Central

    Brock, Dan W

    2003-01-01

    On any plausible account of the basis for health care resource prioritization, the benefits and costs of different alternative resource uses are relevant considerations in the prioritization process. Consequentialists hold that the maximization of benefits with available resources is the only relevant consideration. Non-consequentialists do not reject the relevance of consequences of benefits and costs, but insist that other considerations, and in particular the distribution of benefits and costs, are morally important as well. Whatever one's particular account of morally justified standards for the prioritization of different health interventions, we must be able to measure those interventions' benefits and costs. There are many theoretical and practical difficulties in that measurement, such as how to weigh extending life against improving health and quality of life as well as how different quality of life improvements should be valued, but they are not my concern here. This paper addresses two related issues in assessing benefits and costs for health resource prioritization. First, should benefits be restricted only to health benefits, or include as well other non health benefits such as economic benefits to employers from reducing the lost work time due to illness of their employees? I shall call this the Separate Spheres problem. Second, should only the direct benefits, such as extending life or reducing disability, and direct costs, such as costs of medical personnel and supplies, of health interventions be counted, or should other indirect benefits and costs be counted as well? I shall call this the Indirect Benefits problem. These two issues can have great importance for a ranking of different health interventions by either a cost/benefit or cost effectiveness analysis (CEA) standard. PMID:12773217

  1. Imaging requirements for medical applications of additive manufacturing.

    PubMed

    Huotilainen, Eero; Paloheimo, Markku; Salmi, Mika; Paloheimo, Kaija-Stiina; Björkstrand, Roy; Tuomi, Jukka; Markkola, Antti; Mäkitie, Antti

    2014-02-01

    Additive manufacturing (AM), formerly known as rapid prototyping, is steadily shifting its focus from industrial prototyping to medical applications as AM processes, bioadaptive materials, and medical imaging technologies develop, and the benefits of the techniques gain wider knowledge among clinicians. This article gives an overview of the main requirements for medical imaging affected by needs of AM, as well as provides a brief literature review from existing clinical cases concentrating especially on the kind of radiology they required. As an example application, a pair of CT images of the facial skull base was turned into 3D models in order to illustrate the significance of suitable imaging parameters. Additionally, the model was printed into a preoperative medical model with a popular AM device. Successful clinical cases of AM are recognized to rely heavily on efficient collaboration between various disciplines - notably operating surgeons, radiologists, and engineers. The single main requirement separating tangible model creation from traditional imaging objectives such as diagnostics and preoperative planning is the increased need for anatomical accuracy in all three spatial dimensions, but depending on the application, other specific requirements may be present as well. This article essentially intends to narrow the potential communication gap between radiologists and engineers who work with projects involving AM by showcasing the overlap between the two disciplines.

  2. Social Security's special minimum benefit.

    PubMed

    Olsen, K A; Hoffmeyer, D

    Social Security's special minimum primary insurance amount (PIA) provision was enacted in 1972 to increase the adequacy of benefits for regular long-term, low-earning covered workers and their dependents or survivors. At the time, Social Security also had a regular minimum benefit provision for persons with low lifetime average earnings and their families. Concerns were rising that the low lifetime average earnings of many regular minimum beneficiaries resulted from sporadic attachment to the covered workforce rather than from low wages. The special minimum benefit was seen as a way to reward regular, low-earning workers without providing the windfalls that would have resulted from raising the regular minimum benefit to a much higher level. The regular minimum benefit was subsequently eliminated for workers reaching age 62, becoming disabled, or dying after 1981. Under current law, the special minimum benefit will phase out over time, although it is not clear from the legislative history that this was Congress's explicit intent. The phaseout results from two factors: (1) special minimum benefits are paid only if they are higher than benefits payable under the regular PIA formula, and (2) the value of the regular PIA formula, which is indexed to wages before benefit eligibility, has increased faster than that of the special minimum PIA, which is indexed to inflation. Under the Social Security Trustees' 2000 intermediate assumptions, the special minimum benefit will cease to be payable to retired workers attaining eligibility in 2013 and later. Their benefits will always be larger under the regular benefit formula. As policymakers consider Social Security solvency initiatives--particularly proposals that would reduce benefits or introduce investment risk--interest may increase in restoring some type of special minimum benefit as a targeted protection for long-term low earners. Two of the three reform proposals offered by the President's Commission to Strengthen

  3. Clinically insignificant improvement of prostate cancer prediction by addition of sex steroid hormones and SHBG serum levels to serum PSA, fPSA%, and age in a screening setting.

    PubMed

    Heidegger, Isabel; Popovscaia, Marina; Ramoner, Reinhold; Schäfer, Georg; Stenzel, Birgit; Bektic, Jasmin; Horninger, Wolfgang; Klocker, Helmut

    2012-10-01

    Abstract Various findings implicate sex hormones in prostate growth and development and also in prostate carcinogenesis. We investigated if addition of sex steroid hormone and sex hormone binding globulin (SHBG) serum levels to standard risk assessment parameters [prostate-specific antigen (PSA), free PSA percentage (fPSA%), and age] improves prostate cancer prediction in a PSA screening setting. Steroid hormones testosterone (T), free testosterone (fT), and estradiol (E2), and binding protein SHBG levels were measured in 762 men undergoing prostate biopsy due to suspect PSA serum levels. Prostate cancer was diagnosed in 286 (37.5%) of these men. Our data confirmed that PSA (mean BE=5.09; mean CA=6.05; p=1.24×10-5), fPSA% (mean BE=22.08; mean CA=18.67; p=1.97×10-7), and age (mean BE=60.64; mean CA=64.5; p=7.05×10-10) differentiate men with cancer (CA) and men with benign disease (BE), such as benign prostate hyperplasia. In addition, SHBG (mean BE=50.3; mean CA=54.9; p=0.008) also differed statistically significantly between these two groups. All hormones except E2 and tumor markers correlated significantly with age (T: ρ=-0.09; fT: ρ=-0.27; SHBG: ρ=0.21; PSA: ρ=0.32; and fPSA%: ρ=0.22). Furthermore, we found that PSA correlates with E2 (ρ=0.08), and fPSA% with SHBG (ρ=0.1) and fT (ρ=-0.09). Addition of hormones and SHBG to a baseline marker model including PSA, fPSA%, and age improved cancer prediction in three multivariate classification methods; however, the improvement was minimal. The best improvement by 0.8% was obtained in the logistic regression model with the addition of T and SHBG or of E2 and SHBG, or in the support vector machine model with the addition of SHBG and all steroid hormones to the combination of standard markers PSA, fPSA%, and age; however, this additional gain of accuracy is too small to justify the additional efforts and costs.

  4. Assessing the carbon benefit of saltmarsh restoration

    NASA Astrophysics Data System (ADS)

    Taylor, Benjamin; Paterson, David; Hanley, Nicholas

    2016-04-01

    The quantification of carbon sequestration rates in coastal ecosystems is required to better realise their potential role in climate change mitigation. Through accurate valuation this service can be fully appreciated and perhaps help facilitate efforts to restore vulnerable ecosystems such as saltmarshes. Vegetated coastal ecosystems are suggested to account for approximately 50% of oceanic sedimentary carbon despite their 2% areal extent. Saltmarshes, conservatively estimated to store 430 ± 30 Tg C in surface sediment deposits, have experienced extensive decline in the recent past; through processes such as land use change and coastal squeeze. Saltmarsh habitats offer a range of services that benefit society and the natural world, making their conservation meaningful and beneficial. The associated costs of restoration projects could, in part, be subsidised through payment for ecosystem services, specifically Blue carbon. Additional storage is generated through the (re)vegetation of mudflat areas leading to an altered ecosystem state and function; providing similar benefits to natural saltmarsh areas. The Eden Estuary, Fife, Scotland has been a site of saltmarsh restoration since 2000; providing a temporal and spatial scale to evaluate these additional benefits. The study is being conducted to quantify the carbon benefit of restoration efforts and provide an insight into the evolution of this benefit through sites of different ages. Seasonal sediment deposition and settlement rates are measured across the estuary in: mudflat, young planted saltmarsh, old planted saltmarsh and extant high marsh areas. Carbon values being derived from loss on ignition organic content values. Samples are taken across a tidal cycle on a seasonal basis; providing data on tidal influence, vegetation condition effects and climatic factors on sedimentation and carbon sequestration rates. These data will inform on the annual characteristics of sedimentary processes in the estuary and be

  5. Treatment of local–regional prostate cancer detected by PSA screening: benefits and harms according to prognostic factors

    PubMed Central

    Wever, E M; Heijnsdijk, E A M; Draisma, G; Bangma, C H; Roobol, M J; Schröder, F H; de Koning, H J

    2013-01-01

    Background: Men with screen-detected prostate cancer can choose to undergo immediate curative treatment or enter into an expectant management programme. We quantified how the benefits and harms of immediate treatment vary according to the prognostic factors of clinical T-stage, Gleason score, and patient age. Methods: A microsimulation model based on European Randomized Study of Screening for Prostate Cancer data was used to predict the benefits and harms of immediate treatment versus delayed treatment of local–regional prostate cancer in men aged 55–74 years. Benefits included life-years gained and reduced probability of death from prostate cancer. Harms included lead time and probability of overdiagnosis. Results: The ratio of mean lead time to mean life-years gained ranged from 1.8 to 31.2, and the additional number of treatments required per prostate cancer death prevented ranged from 0.3 to 11.6 across the different prognostic groups. Both harm–benefit ratios were lowest, most favourable, for men aged 55–59 years and diagnosed with moderate-risk prostate cancer. Ratios were high for men aged 70–74 years regardless of clinical T-stage and Gleason score. Conclusion: Men aged 55–59 years with moderate-risk prostate cancer are predicted to derive greatest benefit from immediate curative treatment. Immediate treatment is least favourable for men aged 70–74 years with either low-risk or high-risk prostate cancer. PMID:23674085

  6. Feedback: an essential element of student learning in clinical practice.

    PubMed

    Clynes, Mary P; Raftery, Sara E C

    2008-11-01

    Clinical practice is an essential component of the nursing curriculum. In order for the student to benefit fully from the experience regular performance feedback is required. Feedback should provide the student with information on current practice and offer practical advice for improved performance. The importance of feedback is widely acknowledged however it appears that there is inconsistency in its provision to students. The benefits of feedback include increased student confidence, motivation and self-esteem as well as improved clinical practice. Benefits such as enhanced interpersonal skills and a sense of personal satisfaction also accrue to the supervisor. Barriers to the feedback process are identified as inadequate supervisor training and education, unfavourable ward learning environment and insufficient time spent with students. In addition to the appropriate preparation of the supervisor effective feedback includes an appreciation of the steps of the feedback process, an understanding of the student response to feedback and effective communication skills.

  7. 20 CFR 341.8 - Termination of sickness benefits due to a settlement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... UNEMPLOYMENT INSURANCE ACT STATUTORY LIEN WHERE SICKNESS BENEFITS PAID § 341.8 Termination of sickness benefits... settlement shall be made to the Sickness and Unemployment Benefits Section and shall include the information... Unemployment Benefits Section shall take steps within five additional working days to verify whether there...

  8. Beyond Salaries: Employee Benefits for Teachers in the SREB States.

    ERIC Educational Resources Information Center

    Gaines, Gale F.

    This report summarizes teachers' and employers' contribution rates to retirement, Social Security and Medicare, and major medical plans. Several Southern Regional Education Board (SREB) states have adopted multi-year goals to raise teacher pay, which involves additional costs for benefits tied to those salary increases. These benefits can add…

  9. Bayesian Clinical Trials in Action

    PubMed Central

    Lee, J. Jack; Chu, Caleb T.

    2012-01-01

    Although the frequentist paradigm has been the predominant approach to clinical trial design since the 1940s, it has several notable limitations. The alternative Bayesian paradigm has been greatly enhanced by advancements in computational algorithms and computer hardware. Compared to its frequentist counterpart, the Bayesian framework has several unique advantages, and its incorporation into clinical trial design is occurring more frequently. Using an extensive literature review to assess how Bayesian methods are used in clinical trials, we find them most commonly used for dose finding, efficacy monitoring, toxicity monitoring, diagnosis/decision making, and for studying pharmacokinetics/pharmacodynamics. The additional infrastructure required for implementing Bayesian methods in clinical trials may include specialized software programs to run the study design, simulation, and analysis, and Web-based applications, which are particularly useful for timely data entry and analysis. Trial success requires not only the development of proper tools but also timely and accurate execution of data entry, quality control, adaptive randomization, and Bayesian computation. The relative merit of the Bayesian and frequentist approaches continues to be the subject of debate in statistics. However, more evidence can be found showing the convergence of the two camps, at least at the practical level. Ultimately, better clinical trial methods lead to more efficient designs, lower sample sizes, more accurate conclusions, and better outcomes for patients enrolled in the trials. Bayesian methods offer attractive alternatives for better trials. More such trials should be designed and conducted to refine the approach and demonstrate its real benefit in action. PMID:22711340

  10. Polyimide processing additives

    NASA Technical Reports Server (NTRS)

    Fletcher, James C. (Inventor); Pratt, J. Richard (Inventor); St.clair, Terry L. (Inventor); Stoakley, Diane M. (Inventor); Burks, Harold D. (Inventor)

    1992-01-01

    A process for preparing polyimides having enhanced melt flow properties is described. The process consists of heating a mixture of a high molecular weight poly-(amic acid) or polyimide with a low molecular weight amic acid or imide additive in the range of 0.05 to 15 percent by weight of additive. The polyimide powders so obtained show improved processability, as evidenced by lower melt viscosity by capillary rheometry. Likewise, films prepared from mixtures of polymers with additives show improved processability with earlier onset of stretching by TMA.

  11. Polyimide processing additives

    NASA Technical Reports Server (NTRS)

    Pratt, J. Richard (Inventor); St.clair, Terry L. (Inventor); Stoakley, Diane M. (Inventor); Burks, Harold D. (Inventor)

    1993-01-01

    A process for preparing polyimides having enhanced melt flow properties is described. The process consists of heating a mixture of a high molecular weight poly-(amic acid) or polyimide with a low molecular weight amic acid or imide additive in the range of 0.05 to 15 percent by weight of the additive. The polyimide powders so obtained show improved processability, as evidenced by lower melt viscosity by capillary rheometry. Likewise, films prepared from mixtures of polymers with additives show improved processability with earlier onset of stretching by TMA.

  12. Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed Glioblastoma Patients? A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial

    PubMed Central

    Mao, Ying; Yao, Yu; Zhang, Li-Wei; Lu, Yi-Cheng; Chen, Zhong-Ping; Zhang, Jian-Min; Qi, Song-Tao; You, Chao; Wang, Ren-Zhi; Yang, Shu-Yuan; Zhang, Xiang; Wang, Ji-Sheng; Chen, Ju-Xiang; Yang, Qun-Ying; Shen, Hong; Li, Zhi-Yong; Wang, Xiang; Ma, Wen-Bin; Yang, Xue-Jun; Zhen, Hai-Ning; Zhou, Liang-Fu

    2015-01-01

    Background: The radiochemotherapy regimen concomitantly employing temozolomide (TMZ) chemotherapy and radiotherapy (RT) 4 weeks after surgery, followed by 6 cycles of TMZ is a common treatment for glioblastoma (GBM). However, its median overall survival (OS) is only 14.6 months. This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Methods: A randomized, parallel group, open-label study of 99 newly diagnosed GBM patients was conducted at 10 independent Chinese neurosurgical departments from June 2008 to June 2012. Patients were treated with concomitant radiochemotherapy regimen plus early postsurgical temozolomide (early TMZ group) or standard concomitant radiochemotherapy regimen (control group). Overall response was assessed based on objective tumor assessments, administration of corticosteroid and neurological status test. Hematological, biochemical, laboratory, adverse event (AE), and neurological condition were measured for 24 months of follow-up. The primary efficacy endpoint of this study was overall survival (OS). The secondary endpoint was progression free survival (PFS). Results: The median OS time in the early TMZ group was 17.6 months, compared with 13.2 months in the control group (log-rank test P = 0.021). In addition, the OS rate in the early TMZ group was higher at 6, 12, and 18 months than in the control group, respectively (P < 0.05). The median PFS time was 8.7 months in the early TMZ group and 10.4 months in the control group (log-rank test P = 0.695). AEs occurred in 29 (55.8%) and 31(73.8%) patients respectively in early and control groups, including nausea (15.4% vs. 33.3%), vomiting (7.7% vs. 28.6%), fever (7.7% vs. 11.9%), and headache (3.8% vs. 23.8%). Only 30.8% and 33.3% were drug-related, respectively. Conclusions: Addition of TMZ chemotherapy in the early break of the standard concomitant radiochemotherapy regimen

  13. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to...

  14. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to...

  15. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to...

  16. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to...

  17. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to...

  18. Asthma and anaphylactoid reactions to food additives.

    PubMed Central

    Tarlo, S. M.; Sussman, G. L.

    1993-01-01

    Presumed allergic reactions to hidden food additives are both controversial and important. Clinical manifestations include asthma, urticaria, angioedema, and anaphylactic-anaphylactoid events. Most adverse reactions are caused by just a few additives, such as sulfites and monosodium glutamate. Diagnosis is suspected from the history and confirmed by specific challenge. The treatment is specific avoidance. PMID:8499792

  19. Additional Types of Neuropathy

    MedlinePlus

    ... A A Listen En Español Additional Types of Neuropathy Charcot's Joint Charcot's Joint, also called neuropathic arthropathy, ... can stop bone destruction and aid healing. Cranial Neuropathy Cranial neuropathy affects the 12 pairs of nerves ...

  20. Food Additives and Hyperkinesis

    ERIC Educational Resources Information Center

    Wender, Ester H.

    1977-01-01

    The hypothesis that food additives are causally associated with hyperkinesis and learning disabilities in children is reviewed, and available data are summarized. Available from: American Medical Association 535 North Dearborn Street Chicago, Illinois 60610. (JG)

  1. Smog control fuel additives

    SciTech Connect

    Lundby, W.

    1993-06-29

    A method is described of controlling, reducing or eliminating, ozone and related smog resulting from photochemical reactions between ozone and automotive or industrial gases comprising the addition of iodine or compounds of iodine to hydrocarbon-base fuels prior to or during combustion in an amount of about 1 part iodine per 240 to 10,000,000 parts fuel, by weight, to be accomplished by: (a) the addition of these inhibitors during or after the refining or manufacturing process of liquid fuels; (b) the production of these inhibitors for addition into fuel tanks, such as automotive or industrial tanks; or (c) the addition of these inhibitors into combustion chambers of equipment utilizing solid fuels for the purpose of reducing ozone.

  2. What Else Should I Know about Clinical Research?

    MedlinePlus

    ... to have the potential risks, benefits, alternatives, and responsibilities of the clinical research explained to them before ... informed about the potential risks, benefits, alternatives, and responsibilities of the clinical trial before they agree to ...

  3. Akt Phosphorylation at Ser473 Predicts Benefit of Paclitaxel Chemotherapy in Node-Positive Breast Cancer

    PubMed Central

    Yang, Sherry X.; Costantino, Joseph P.; Kim, Chungyeul; Mamounas, Eleftherios P.; Nguyen, Dat; Jeong, Jong-Hyeon; Wolmark, Norman; Kidwell, Kelley; Paik, Soonmyung; Swain, Sandra M.

    2010-01-01

    Purpose We tested the hypothesis that Akt-Ser473 phosphorylation (pAkt) predicts benefit from the sequential addition of paclitaxel to adjuvant doxorubicin plus cyclophosphamide (AC) chemotherapy in patients with node-positive breast cancer participating in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-28 trial. Patients and Methods Primary tumors from the NSABP B-28 trial tissue microarray were available from 1,581 of 3,060 patients who were randomly assigned to receive either four cycles of AC alone or followed by four cycles of paclitaxel. Immunohistochemistry and quantitative analysis of pAkt were performed at the National Cancer Institute blinded to clinical outcome. Association between pAkt and clinical outcome was assessed using multivariate Cox modeling adjusting for age, tumor size, number of positive nodes, tumor grade, estrogen receptor status, and human epidermal growth factor receptor 2 status. Results With a median follow-up of 9.1 years, there were no differences in disease-free survival (adjusted hazard ratio [HR], 1.02; P = .81) or overall survival (HR, 0.97; P = .80) with and without receiving paclitaxel among 975 patients with pAkt-negative tumors. In 606 patients with pAkt-positive tumors, the sequential addition of paclitaxel resulted in a 26% improvement in disease-free survival (HR, 0.74; P = .02) or a 20% improvement in overall survival (HR, 0.80; P = .17). Conclusion pAkt significantly predicts disease-free benefit from the sequential addition of paclitaxel to AC chemotherapy in patients with node-positive breast cancer. Patients with pAkt-negative breast tumors do not appear to benefit from the addition of paclitaxel. PMID:20479407

  4. Early access programs: Benefits, challenges, and key considerations for successful implementation

    PubMed Central

    Patil, Sanjaykumar

    2016-01-01

    Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant, and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global commercialization strategies. This white paper outlines various circumstances to be considered for the implementation of EAPs named patient programs, the regulatory landscape, the benefits and challenges associated with implementing these programs and the key considerations for their successful implementation. PMID:26955570

  5. Early access programs: Benefits, challenges, and key considerations for successful implementation.

    PubMed

    Patil, Sanjaykumar

    2016-01-01

    Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant, and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global commercialization strategies. This white paper outlines various circumstances to be considered for the implementation of EAPs named patient programs, the regulatory landscape, the benefits and challenges associated with implementing these programs and the key considerations for their successful implementation. PMID:26955570

  6. Who Benefits from Volunteering? Variations in Perceived Benefits

    ERIC Educational Resources Information Center

    Morrow-Howell, Nancy; Hong, Song-Iee; Tang, Fengyan

    2009-01-01

    Purpose: The purpose of this study was to document the benefits of volunteering perceived by older adults and to explain variation in these self-perceived benefits. Design and Methods: This is a quantitative study of 13 volunteer programs and 401 older adults serving in those programs. Program directors completed telephone interviews, and older…

  7. Update on tanning: More risks, fewer benefits.

    PubMed

    O'Leary, Ryan E; Diehl, Joseph; Levins, Paul C

    2014-03-01

    The tanning response, classically defined as increased cutaneous pigmentation after solar ultraviolet light exposure, encompasses a variety of protective, reparative, and cosmetic issues. The tanning story is continuously evolving as basic science, clinical research, and public health studies shed light on topics involving: the physiologic mechanisms of tanning, the medical benefits of tanning, the role of sunscreens, the development of "sunless" self-tanners, the use of photocarcinogenic indoor tanning services, and the relatively recent development and promulgation of α-melanocyte-stimulating hormone analogues. High-risk tanning behaviors have become increasingly popular and the incidence of melanoma has risen more rapidly than any other cancer. This review will focus on the risks and benefits of each type of tanning, with an emphasis on issues pertinent to dermatologists who care for adolescents and young adults.

  8. Clinical cytomics

    NASA Astrophysics Data System (ADS)

    Tárnok, Attila; Mittag, Anja; Lenz, Dominik

    2006-02-01

    The goal of predictive medicine is the detection of changes in patient's state prior to the clinical manifestation of the deterioration of the patients current status. Therefore, both the diagnostic of diseases like cancer, coronary atherosclerosis or congenital heart failure and the prognosis of the effect specific therapeutics on patients outcome are the main fields of predictive medicine. Clinical Cytomcs is based on the analysis of specimens from the patient by Cytomic technologies that are mainly imaging based techniques and their combinations with other assays. Predictive medicine aims at the recognition of the "fate" of each individual patients in order to yield unequivocal indications for decision making (i.e. how does the patient respond to therapy, react to medication etc.). This individualized prediction is based on the Predictive Medicine by Clinical Cytomics concept. These considerations have recently stimulated the idea of the Human Cytome Project. A major focus of the Human Cytome Project is multiplexed cy-tomic analysis of individual cells of the patient, extraction of predictive information and individual prediction that merges into individualized therapy. Although still at the beginning, Clinical Cytomics is a promising new field that may change therapy in the near future for the benefit of the patients.

  9. Health Promotion and Aging: Educational and Clinical Initiatives by the Federal Government.

    ERIC Educational Resources Information Center

    Haber, David

    2002-01-01

    Discusses positive and negative effects of five federal health promotion initiatives: Medicare Prevention Benefits, Surgeon General's Reports, Healthy People 2000 and 2001, Guide to Clinical Preventive Services, and Put Prevention into Practice Campaign. Recommends additional research and coordination with state and private sector agencies.…

  10. Applying developmental programming to clinical obstetrics: my ward round.

    PubMed

    Painter, R C

    2015-10-01

    The theory of developmental programming is supported by accumulating evidence, both observational and experimental. The direct application of the principles of developmental programming by clinicians to benefit pregnant women remains an area of limited attention. Examining a selection of inpatients at an obstetric referral center, I searched for situations in which clinical decision making could be driven by the principles of developmental programming. I also looked for situations in which the clinical research agenda could be dictated by these concepts. In the decision to undertake preventive measures to avoid preeclampsia, the offspring's perspective may support more liberal application of calcium and aspirin. Consideration of the long-term health perspective of the offspring could drive choices in the management of obesity and diabetes in pregnancy. The administration of corticosteroids in women delivering by elective cesarean at term may have modest short-term benefits, but additional trials are necessary to investigate long-term offspring health. The offspring of women suffering hyperemesis gravidarum may benefit from nutritional therapy. The long-term health of the offspring could affect couples' choice for IVF or expectant management. Applying the principles of developmental programming to the management of pregnant women could drive clinical decision making and is driving the clinical research agenda. Increasingly, developmental programming concepts are becoming an integral part of clinical practice, as well as determining the choice of outcomes in trials in obstetrics and fertility medicine. The presented cases underscore the need for more research to guide clinical practice.

  11. Additive Manufacturing Infrared Inspection

    NASA Technical Reports Server (NTRS)

    Gaddy, Darrell

    2014-01-01

    Additive manufacturing is a rapid prototyping technology that allows parts to be built in a series of thin layers from plastic, ceramics, and metallics. Metallic additive manufacturing is an emerging form of rapid prototyping that allows complex structures to be built using various metallic powders. Significant time and cost savings have also been observed using the metallic additive manufacturing compared with traditional techniques. Development of the metallic additive manufacturing technology has advanced significantly over the last decade, although many of the techniques to inspect parts made from these processes have not advanced significantly or have limitations. Several external geometry inspection techniques exist such as Coordinate Measurement Machines (CMM), Laser Scanners, Structured Light Scanning Systems, or even traditional calipers and gages. All of the aforementioned techniques are limited to external geometry and contours or must use a contact probe to inspect limited internal dimensions. This presentation will document the development of a process for real-time dimensional inspection technique and digital quality record of the additive manufacturing process using Infrared camera imaging and processing techniques.

  12. Phenylethynyl Containing Reactive Additives

    NASA Technical Reports Server (NTRS)

    Connell, John W. (Inventor); Smith, Joseph G., Jr. (Inventor); Hergenrother, Paul M. (Inventor)

    2002-01-01

    Phenylethynyl containing reactive additives were prepared from aromatic diamine, containing phenylethvnvl groups and various ratios of phthalic anhydride and 4-phenylethynviphthalic anhydride in glacial acetic acid to form the imide in one step or in N-methyl-2-pvrrolidinone to form the amide acid intermediate. The reactive additives were mixed in various amounts (10% to 90%) with oligomers containing either terminal or pendent phenylethynyl groups (or both) to reduce the melt viscosity and thereby enhance processability. Upon thermal cure, the additives react and become chemically incorporated into the matrix and effect an increase in crosslink density relative to that of the host resin. This resultant increase in crosslink density has advantageous consequences on the cured resin properties such as higher glass transition temperature and higher modulus as compared to that of the host resin.

  13. Quantifying benefit-risk preferences for medical interventions: an overview of a growing empirical literature.

    PubMed

    Brett Hauber, A; Fairchild, Angelyn O; Reed Johnson, F

    2013-08-01

    here demonstrates that this body of research already is substantial, and it appears that the number of benefit-risk preference studies in the literature will continue to increase. In addition, benefit-risk preference-elicitation methods have been applied to a variety of healthcare decisions and medical interventions, including pharmaceuticals, medical devices, surgical and medical procedures, and diagnostics, as well as resource-allocation decisions such as facility placement. While preference-elicitation approaches may differ across studies, all of the studies described in this review can be used to provide quantitative measures of the tradeoffs patients and other decision makers are willing to make between benefits and risks of medical interventions. Eliciting and quantifying the preferences of decision makers allows for a formal, evidence-based consideration of decision-makers' values that currently is lacking in regulatory decision making. Future research in this area should focus on two primary issues-developing best-practice standards for preference-elicitation studies and developing methods for combining stated preferences and clinical data in a manner that is both understandable and useful to regulatory agencies.

  14. Immuno-modulation and anti-inflammatory benefits of antibiotics: the example of tilmicosin.

    PubMed

    Buret, André G

    2010-01-01

    Exaggerated immune responses, such as those implicated in severe inflammatory reactions, are costly to the metabolism. Inflammation and pro-inflammatory mediators negatively affect production in the food animal industry by reducing growth, feed intake, reproduction, milk production, and metabolic health. An ever-increasing number of findings have established that antibiotics, macrolides in particular, may generate anti-inflammatory effects, including the modulation of pro-inflammatory cytokines and the alteration of neutrophil function. The effects are time- and dose-dependent, and the mechanisms responsible for these phenomena remain incompletely understood. Recent studies, mostly using the veterinary macrolide tilmicosin, may have shed new light on the mode of action of some macrolides and their anti-inflammatory properties. Indeed, research findings demonstrate that this compound, amongst others, induces neutrophil apoptosis, which in turn provides anti-inflammatory benefits. Studies using tilmicosin model systems in vitro and in vivo demonstrate that this antibiotic has potent immunomodulatory effects that may explain why at least parts of its clinical benefits are independent of anti-microbial effects. More research is needed, using this antibiotic and others that may have similar properties, to clarify the biological mechanisms responsible for antibiotic-induced neutrophil apoptosis, and how this, in turn, may provide enhanced clinical benefits. Such studies may help establish a rational basis for the development of novel, efficacious, anti-microbial compounds that generate anti-inflammatory properties in addition to their antibacterial effects.

  15. Taxability of Educational Benefits Trusts

    ERIC Educational Resources Information Center

    Temple Law Quarterly, 1976

    1976-01-01

    Corporations have found the promise of providing a college education to the children of employees--without the recognition of income to the parent-employee--to be a popular fringe benefit. The Internal Revenue Service has attacked educational benefit trusts in Revenue Ruling 75-448. Implications are discussed. (LBH)

  16. Who Benefits from Pension Enhancements?

    ERIC Educational Resources Information Center

    Koedel, Cory; Ni, Shawn; Podgursky, Michael

    2014-01-01

    During the late 1990s public pension funds across the United States accrued large actuarial surpluses. The seemingly flush conditions of the pension funds led legislators in most states to substantially improve retirement benefits for public workers, including teachers. In this study we examine the benefit enhancements to the teacher pension…

  17. Gauging Technology Costs and Benefits

    ERIC Educational Resources Information Center

    Kaestner, Rich

    2007-01-01

    Regardless of the role technology plays in a school district, district personnel should know the costs associated with technology, understand the consequences of technology purchases, and be able to measure the benefits of technology, so they can make more informed decisions. However, determining costs and benefits of current technology or…

  18. Multifunctional fuel additives

    SciTech Connect

    Baillargeon, D.J.; Cardis, A.B.; Heck, D.B.

    1991-03-26

    This paper discusses a composition comprising a major amount of a liquid hydrocarbyl fuel and a minor low-temperature flow properties improving amount of an additive product of the reaction of a suitable diol and product of a benzophenone tetracarboxylic dianhydride and a long-chain hydrocarbyl aminoalcohol.

  19. 20 CFR 416.263 - No additional application needed.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false No additional application needed. 416.263 Section 416.263 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Eligibility Special Provisions for People Who Work Despite A...

  20. 20 CFR 416.263 - No additional application needed.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false No additional application needed. 416.263 Section 416.263 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Eligibility Special Provisions for People Who Work Despite A...

  1. [Sauna: cardiac and vascular benefits and risks].

    PubMed

    Kluger, Nicolas

    2011-10-01

    Sauna bathing is a traditional activity in Finland that has become popular for the past decades in Europe and in the United States. However, it is still considered that patients with cardiovascular pathologies should avoid sauna bathing. Clinical studies have nevertheless showed that sauna was safe for patients with a stable heart condition (hypertension, coronary disease, stable controlled chronic heart failure). Besides, results from recent Japanese studies seem to point out potential benefits for patients with chronic congestive heart failure, but the results need confirmation.

  2. Highway noise barrier perceived benefit

    NASA Astrophysics Data System (ADS)

    May, D. N.; Osman, M. M.

    1980-05-01

    A laboratory experiment was performed in which 82 subjects judged the benefit of a noise barrier by listening to tape recordings of before-barrier and after-barrier traffic noise. These perceived benefit judgments were related by regression analysis to the barrier attenuation, the before-barrier traffic sound level, and a music background level, all of which were varied over the course of the experiment. Prediction equations were developed for barrier benefit in terms of these sound levels, their purpose being to provide a model for barrier benefit that can be used in barrier site selection and design. An unexpected finding was that barrier benefit was highest when before-barrier sound levels were lowest: i.e., subjects preferred a noise barrier that solved a moderate noise problem over an equally-attenuating barrier that only partially solved a more severe noise problem.

  3. The principles of quality-associated costing: derivation from clinical transfusion practice.

    PubMed

    Trenchard, P M; Dixon, R

    1997-01-01

    As clinical transfusion practice works towards achieving cost-effectiveness, prescribers of blood and its derivatives must be certain that the prices of such products are based on real manufacturing costs and not market forces. Using clinical cost-benefit analysis as the context for the costing and pricing of blood products, this article identifies the following two principles: (1) the product price must equal the product cost (the "price = cost" rule) and (2) the product cost must equal the real cost of product manufacture. In addition, the article describes a new method of blood product costing, quality-associated costing (QAC), that will enable valid cost-benefit analysis of blood products.

  4. American Society of Clinical Oncology guidelines for the use of hematopoietic colony-stimulating factors.

    PubMed

    Ozer, H

    1996-01-01

    The hematopoietic colony-stimulating factors have been introduced into clinical practice as additional supportive measures that can reduce the likelihood of neutropenic complications due to chemotherapy. Clinical benefit has been shown, but the high cost of colony-stimulating factors has led to concern about their appropriate use. The American Society of Clinical Oncology has established evidence-based, clinical practice guidelines for the use of colony-stimulating factors in patients who are not enrolled in clinical trials. An expert multidisciplinary panel reviewed the clinical data documenting the activity of colony-stimulating factors. For each common clinical situation, the panel formulated a guideline to encourage reasonable use of colony-stimulating factors to preserve effectiveness but discourage excess use when little marginal benefit is anticipated. Outcomes considered in evaluating colony stimulating factor benefit included duration of neutropenia, incidence of febrile neutropenia, incidence and duration of antibiotic use, frequency and duration of hospitalization, infectious mortality, chemotherapy dose intensity, chemotherapy efficacy, quality of life, colony-stimulating factor toxicity, and economic impact. To the extent that these data were available, the panel placed greatest value on survival benefit, reduction in rates of febrile neutropenia, decreased hospitalization, and reduced costs. Lesser value was placed on alterations in absolute neutrophil counts.

  5. Clinical excellence in cardiology.

    PubMed

    Ziegelstein, Roy C

    2011-08-15

    A recent study identified 7 domains of clinical excellence on the basis of interviews with "clinically excellent" physicians at academic institutions in the United States: (1) communication and interpersonal skills, (2) professionalism and humanism, (3) diagnostic acumen, (4) skillful negotiation of the health care system, (5) knowledge, (6) taking a scholarly approach to clinical practice, and (7) having passion for clinical medicine. What constitutes clinical excellence in cardiology has not previously been defined. The author discusses clinical excellence in cardiology using the framework of these 7 domains and also considers the additional domain of clinical experience. Specific aspects of the domains of clinical excellence that are of greatest relevance to cardiology are highlighted. In conclusion, this discussion characterizes what constitutes clinical excellence in cardiology and should stimulate additional discussion of the topic and an examination of how the domains of clinical excellence in cardiology are related to specific patient outcomes.

  6. Thrombectomy assisted by carotid stenting in acute ischemic stroke management: benefits and harms.

    PubMed

    Steglich-Arnholm, Henrik; Holtmannspötter, Markus; Kondziella, Daniel; Wagner, Aase; Stavngaard, Trine; Cronqvist, Mats E; Hansen, Klaus; Højgaard, Joan; Taudorf, Sarah; Krieger, Derk Wolfgang

    2015-12-01

    Extracranial carotid artery occlusion or high-grade stenosis with concomitant intracranial embolism causes severe ischemic stroke and shows poor response rates to intravenous thrombolysis (IVT). Endovascular therapy (EVT) utilizing thrombectomy assisted by carotid stenting was long considered risky because of procedural complexities and necessity of potent platelet inhibition-in particular following IVT. This study assesses the benefits and harms of thrombectomy assisted by carotid stenting and identifies factors associated with clinical outcome and procedural complications. Retrospective single-center analysis of 47 consecutive stroke patients with carotid occlusion or high-grade stenosis and concomitant intracranial embolus treated between September 2011 and December 2014. Benefits included early improvement of stroke severity (NIHSS ≥ 10) or complete remission within 72 h and favorable long-term outcome (mRS ≤ 2). Harms included complications during and following EVT. Mean age was 64.3 years (standard deviation ±12.5), 40 (85%) patients received IVT initially. Median NIHSS was 16 (inter-quartile range 14-19). Mean time from stroke onset to recanalization was 311 min (standard deviation ±78.0). Early clinical improvement was detected in 22 (46%) patients. Favorable outcome at 3 months occurred in 32 (68%) patients. Expedited patient management was associated with favorable clinical outcome. Two (4%) patients experienced symptomatic hemorrhage. Eight (17%) patients experienced stent thrombosis. Four (9%) patients died. Thrombectomy assisted by carotid stenting seems beneficial and reasonably safe with a promising rate of favorable outcome. Nevertheless, adverse events and complications call for additional clinical investigations prior to recommendation as clinical standard. Expeditious patient management is central to achieve good clinical outcome. PMID:26345413

  7. 34 CFR 106.56 - Fringe benefits.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... benefits. (a) Fringe benefits defined. For purposes of this part, fringe benefits means: Any medical, hospital, accident, life insurance or retirement benefit, service, policy or plan, any profit-sharing...

  8. 20 CFR 655.154 - Additional positive recruitment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 3 2014-04-01 2014-04-01 false Additional positive recruitment. 655.154... Employment in the United States (H-2A Workers) Post-Acceptance Requirements § 655.154 Additional positive recruitment. (a) Where to conduct additional positive recruitment. The employer must conduct...

  9. 20 CFR 655.154 - Additional positive recruitment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Additional positive recruitment. 655.154... Employment in the United States (H-2A Workers) Post-Acceptance Requirements § 655.154 Additional positive recruitment. (a) Where to conduct additional positive recruitment. The employer must conduct...

  10. 20 CFR 655.154 - Additional positive recruitment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Additional positive recruitment. 655.154... Employment in the United States (H-2A Workers) Post-Acceptance Requirements § 655.154 Additional positive recruitment. (a) Where to conduct additional positive recruitment. The employer must conduct...

  11. 20 CFR 655.154 - Additional positive recruitment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Additional positive recruitment. 655.154... Employment in the United States (H-2A Workers) Post-Acceptance Requirements § 655.154 Additional positive recruitment. (a) Where to conduct additional positive recruitment. The employer must conduct...

  12. Vinyl capped addition polyimides

    NASA Technical Reports Server (NTRS)

    Vannucci, Raymond D. (Inventor); Malarik, Diane C. (Inventor); Delvigs, Peter (Inventor)

    1991-01-01

    Polyimide resins (PMR) are generally useful where high strength and temperature capabilities are required (at temperatures up to about 700 F). Polyimide resins are particularly useful in applications such as jet engine compressor components, for example, blades, vanes, air seals, air splitters, and engine casing parts. Aromatic vinyl capped addition polyimides are obtained by reacting a diamine, an ester of tetracarboxylic acid, and an aromatic vinyl compound. Low void materials with improved oxidative stability when exposed to 700 F air may be fabricated as fiber reinforced high molecular weight capped polyimide composites. The aromatic vinyl capped polyimides are provided with a more aromatic nature and are more thermally stable than highly aliphatic, norbornenyl-type end-capped polyimides employed in PMR resins. The substitution of aromatic vinyl end-caps for norbornenyl end-caps in addition polyimides results in polymers with improved oxidative stability.

  13. Tackifier for addition polyimides

    NASA Technical Reports Server (NTRS)

    Butler, J. M.; St.clair, T. L.

    1980-01-01

    A modification to the addition polyimide, LaRC-160, was prepared to improve tack and drape and increase prepeg out-time. The essentially solventless, high viscosity laminating resin is synthesized from low cost liquid monomers. The modified version takes advantage of a reactive, liquid plasticizer which is used in place of solvent and helps solve a major problem of maintaining good prepeg tack and drape, or the ability of the prepeg to adhere to adjacent plies and conform to a desired shape during the lay up process. This alternate solventless approach allows both longer life of the polymer prepeg and the processing of low void laminates. This approach appears to be applicable to all addition polyimide systems.

  14. Electrophilic addition of astatine

    SciTech Connect

    Norseev, Yu.V.; Vasaros, L.; Nhan, D.D.; Huan, N.K.

    1988-03-01

    It has been shown for the first time that astatine is capable of undergoing addition reactions to unsaturated hydrocarbons. A new compound of astatine, viz., ethylene astatohydrin, has been obtained, and its retention numbers of squalane, Apiezon, and tricresyl phosphate have been found. The influence of various factors on the formation of ethylene astatohydrin has been studied. It has been concluded on the basis of the results obtained that the univalent cations of astatine in an acidic medium is protonated hypoastatous acid.

  15. Functional Generalized Additive Models.

    PubMed

    McLean, Mathew W; Hooker, Giles; Staicu, Ana-Maria; Scheipl, Fabian; Ruppert, David

    2014-01-01

    We introduce the functional generalized additive model (FGAM), a novel regression model for association studies between a scalar response and a functional predictor. We model the link-transformed mean response as the integral with respect to t of F{X(t), t} where F(·,·) is an unknown regression function and X(t) is a functional covariate. Rather than having an additive model in a finite number of principal components as in Müller and Yao (2008), our model incorporates the functional predictor directly and thus our model can be viewed as the natural functional extension of generalized additive models. We estimate F(·,·) using tensor-product B-splines with roughness penalties. A pointwise quantile transformation of the functional predictor is also considered to ensure each tensor-product B-spline has observed data on its support. The methods are evaluated using simulated data and their predictive performance is compared with other competing scalar-on-function regression alternatives. We illustrate the usefulness of our approach through an application to brain tractography, where X(t) is a signal from diffusion tensor imaging at position, t, along a tract in the brain. In one example, the response is disease-status (case or control) and in a second example, it is the score on a cognitive test. R code for performing the simulations and fitting the FGAM can be found in supplemental materials available online.

  16. Maximizing the benefits of antiretroviral therapy for key affected populations

    PubMed Central

    Grubb, Ian R; Beckham, Sarah W; Kazatchkine, Michel; Thomas, Ruth M; Albers, Eliot R; Cabral, Mauro; Lange, Joep; Vella, Stefano; Kurian, Manoj; Beyrer, Chris

    2014-01-01

    Introduction Scientific research has demonstrated the clinical benefits of earlier initiation of antiretroviral treatment (ART), and that ART can markedly reduce HIV transmission to sexual partners. Ensuring universal access to ART for those who need it has long been a core principle of the HIV response, and extending the benefits of ART to key populations is critical to increasing the impact of ART and the overall effectiveness of the HIV response. However, this can only be achieved through coordinated efforts to address political, social, legal and economic barriers that key populations face in accessing HIV services. Discussion Recent analyses show that HIV prevalence levels among key populations are far higher than among the general population, and they experience a range of biological and behavioural factors, and social, legal and economic barriers that increase their vulnerability to HIV and have resulted in alarmingly low ART coverage. World Health Organization 2014 consolidated guidance on HIV among key populations offers the potential for increased access to ART by key populations, following the same principles as for the general adult population. However, it should not be assumed that key populations will achieve greater access to ART unless stigma, discrimination and punitive laws, policies and practices that limit access to ART and other HIV interventions in many countries are addressed. Conclusions Rights-based approaches and investments in critical enablers, such as supportive legal and policy environments, are essential to enable wider access to ART and other HIV interventions for key populations. The primary objective of ART should always be to treat the person living with HIV; prevention is an important, additional benefit. ART should be provided only with informed consent. The preventive benefits of treatment must not be used as a pretext for failure to provide other necessary HIV programming for key populations, including comprehensive harm

  17. Potential Benefits of Commissioning California Homes

    SciTech Connect

    Matson, Nance; Wray, Craig; Walker, Iain; Sherman, Max

    2002-01-01

    Commissioning California's houses can result in better performing systems and houses. In turn, this will result in more efficient use of energy, carbon emission reductions, and improved occupant comfort. In particular, commissioning houses can save a significant amount of HVAC-related energy (15 to 30% in existing houses, 10 to 20% in new conventional houses, and up to 8% in advanced energy efficiency houses). The process that we considered includes corrective measures that could be implemented together during construction or during a single site visit (e.g., air tightening, duct sealing, and refrigerant and air handler airflow corrections in a new or existing house). Taking advantage of additional, more complex opportunities (e.g., installing new windows in an existing house, replacing the heating and air conditioning system in a new or existing house) can result in additional HVAC-related energy savings (60 to 75% in existing houses, and 50 to 60% in new conventional houses). The commissioning-related system and house performance improvements and energy savings translate to additional benefits throughout California and beyond. By applying commissioning principles to their work, the building community (builders and contractors) benefit from reduced callbacks and lower warranty costs. HERS raters and inspectors will have access to an expanded market sector. As the commissioning process rectifies construction defects and code problems, building code officials benefit from better compliance with codes. The utilities benefit from reduced peak demand, which can translate into lower energy acquisition costs. As houses perform closer to expectations, governmental bodies (e.g., the California Energy Commission and the Air Resources Board) benefit from greater assurance that actual energy consumption and carbon emissions are closer to the levels mandated in codes and standards, resulting in better achievement of state energy conservation and environmental goals. California

  18. Benefit adequacy among elderly Social Security retired-worker beneficiaries and the SSI federal benefit rate.

    PubMed

    Rupp, Kalman; Strand, Alexander; Davies, Paul; Sears, Jim

    2007-01-01

    administrative simplicity behind these screening errors also results in additional program cost that may be perceived as substantial. We estimate that an FBR-level minimum benefit would increase aggregate program cost for retired workers aged 65 or older by roughly 2 percent. There are two fundamental reasons for these findings. First, the concept of an FBR-level minimum benefit looks at the individual or married couple in artificial isolation; however, the family is the main consumption unit in our society. The income of an unmarried partner or family members other than a married spouse is ignored. Second, individuals and couples may also have income from sources other than Social Security or SSI, which is also ignored by a simple FBR-based minimum benefit concept. The substantial empirical magnitude of measurement error arising from these conceptual simplifications naturally leads to the assessment of the tradeoff between target effectiveness and administrative simplicity. To facilitate this analysis, we simulate the potential effect of alternative screening methods designed to increase target effectiveness; while reducing program cost, such alternatives also may increase administrative complexity. For example, considering the combined Social Security benefit of a married couple (rather than looking at the husband and wife in isolation) might substantially increase target effectiveness with a relatively small increase in administrative complexity. Adding a family income screen might increase administrative complexity to a greater degree, but also would increase target effectiveness dramatically. The results also suggest that at some point adding new screens-such as a comprehensive asset test-may drastically increase administrative complexity with diminishing returns in terms of increased target effectiveness and reduced program cost. Whether a broad-based minimum benefit concept that is not tied to previous work experience is perceived by policymakers as desirable or not may

  19. [How relevant are the benefits for participation at working life for psychosomatic inpatient rehabilitation].

    PubMed

    Kobelt, Axel; Grosch, Eberhard Virtus; Gutenbrunner, Christoph

    2006-01-01

    Beside the stabilization of the health status the reintegration into employment are the main ambitions of the medical rehabilitation. Thereby occupational rehabilitation plays an important role in the rehabilitation system. To recommend occupational rehabilitation physicians have to know the requirements patients have to comply with. In addition formal conditions of the medical report upon discharge have to be accomplish that benefits for participation at working life will be provided by the pension insurance. In our study the differences of the amount of recommendation for occupational rehabilitation and the appraisal of the ability to work in the medical reports upon discharge of psychosomatic and orthopaedic patients are examined. The results show that psychosomatic patients achieved significantly less recommendations for occupational rehabilitation than orthopaedic patients. At the same time more psychosomatic patients who achieved the recommendation didn't claim benefits for participation at working life. In addition orthopaedic patients get a rehabilitation approval certification more often than psychosomatic patients. At the same time it appears that maybe the recommending clinics were insecure about the connection between the occupational capacity assessment and the recommendations for benefits for participation at work life. The outcomes presume that work place problems in medical rehabilitation are not taken into consideration adequately.

  20. Benefits of acid rain controls

    SciTech Connect

    Hawkins, D.G.

    1984-04-01

    The acid rain debate has been distorted by a mistaken political paradigm. This paradigm holds that acid rain controls will benefit only a few lakes and streams, mostly in the Adirondack Mountains in northeastern New York State. It holds that the costs of a control program will fall on the Midwest but that none of the benefits will occur there since no sensitive lakes and streams are found in that area. The author discussed this problem and pointed out that sulfur dioxide was responsible for several types of pollution damage and that all the states would benefit from the reduction of sulfur dioxide emissions.

  1. Pharmacy benefits: new concepts in plan design.

    PubMed

    Goff, Veronica V

    2002-03-01

    This issue brief examines changes to prescription drug benefit coverage in large employer plans and implications for a Medicare prescription drug benefit. The brief discusses reasons behind employer benefit plan redesign and recent coverage trends, as well as potential paths to modernize benefits. Information is based on a literature review and conversations and interviews with employers, benefit consultants, and pharmacy benefit management executives.

  2. Clinical Application of Bioartificial Liver Support Systems

    PubMed Central

    van de Kerkhove, Maarten Paul; Hoekstra, Ruurdtje; Chamuleau, Robert A. F. M.; van Gulik, Thomas M.

    2004-01-01

    Objective: To review the present status of bioartificial liver (BAL) devices and their obtained clinical results. Background: Acute liver failure (ALF) is a disease with a high mortality. Standard therapy at present is liver transplantation. Liver transplantation is hampered by the increasing shortage of organ donors, resulting in high incidence of patients with ALF dying on the transplantation waiting list. Among a variety of liver assist therapies, BAL therapy is marked as the most promising solution to bridge ALF patients to liver transplantation or to liver regeneration, because several BAL systems showed significant survival improvement in animal ALF studies. Until today, clinical application of 11 different BAL systems has been reported. Methods: A literature review was performed using MEDLINE and additional library searches. Only BAL systems that have been used in a clinical trial were included in this review. Results: Eleven BAL systems found clinical application. Three systems were studied in a controlled trial, showing no significant survival benefits, in part due to the insufficient number of patients included. The other systems were studied in a phase I trial or during treatment of a single patient and all showed to be safe. Most BAL therapies resulted in improvement of clinical and biochemical parameters. Conclusions: Bioartificial liver therapy for bridging patients with ALF to liver transplantation or liver regeneration is promising. Its clinical value awaits further improvement of BAL devices, replacement of hepatocytes of animal origin by human hepatocytes, and assessment in controlled clinical trials. PMID:15273544

  3. Benefits of Metformin Use for Cholangiocarcinoma.

    PubMed

    Kaewpitoon, Soraya J; Loyd, Ryan A; Rujirakul, Ratana; Panpimanmas, Sukij; Matrakool, Likit; Tongtawee, Taweesak; Kootanavanichpong, Nusorn; Kompor, Ponthip; Chavengkun, Wasugree; Kujapun, Jirawoot; Norkaew, Jun; Ponphimai, Sukanya; Padchasuwan, Natnapa; Pholsripradit, Poowadol; Eksanti, Thawatchai; Phatisena, Tanida; Kaewpitoon, Natthawut

    2015-01-01

    Metformin is an oral anti-hyperglycemic agent, which is the most commonly prescribed medication in the treatment of type-2 diabetes mellitus. It is purportedly associated with a reduced risk for various cancers, mainly exerting anti-proliferation effects on various human cancer cell types, such as pancreas, prostate, breast, stomach and liver. This mini-review highlights the risk and benefit of metformin used for cholangiocarcinoma (CCA) prevention and therapy. The results indicated metformin might be a quite promising strategy CCA prevention and treatment, one mechanism being inhibition of CCA tumor growth by cell cycle arrest in both in vitro and in vivo. The AMPK/mTORC1 pathway in intrahepatic CCA cells is targeted by metformin. Furthermore, metformin inhibited CCA tumor growth via the regulation of Drosha-mediated expression of multiple carcinogenic miRNAs. The use of metformin seems to be safe in patients with cirrhosis, and provides a survival benefit. Once hepatic malignancies are already established, metformin does not offer any therapeutic potential. Clinical trials and epidemiological studies of the benefit of metformin use for CCA should be conducted. To date, whether metformin as a prospective chemotherapeutic for CCA is still questionable and waits further atttention. PMID:26745042

  4. Benefits of Metformin Use for Cholangiocarcinoma.

    PubMed

    Kaewpitoon, Soraya J; Loyd, Ryan A; Rujirakul, Ratana; Panpimanmas, Sukij; Matrakool, Likit; Tongtawee, Taweesak; Kootanavanichpong, Nusorn; Kompor, Ponthip; Chavengkun, Wasugree; Kujapun, Jirawoot; Norkaew, Jun; Ponphimai, Sukanya; Padchasuwan, Natnapa; Pholsripradit, Poowadol; Eksanti, Thawatchai; Phatisena, Tanida; Kaewpitoon, Natthawut

    2015-01-01

    Metformin is an oral anti-hyperglycemic agent, which is the most commonly prescribed medication in the treatment of type-2 diabetes mellitus. It is purportedly associated with a reduced risk for various cancers, mainly exerting anti-proliferation effects on various human cancer cell types, such as pancreas, prostate, breast, stomach and liver. This mini-review highlights the risk and benefit of metformin used for cholangiocarcinoma (CCA) prevention and therapy. The results indicated metformin might be a quite promising strategy CCA prevention and treatment, one mechanism being inhibition of CCA tumor growth by cell cycle arrest in both in vitro and in vivo. The AMPK/mTORC1 pathway in intrahepatic CCA cells is targeted by metformin. Furthermore, metformin inhibited CCA tumor growth via the regulation of Drosha-mediated expression of multiple carcinogenic miRNAs. The use of metformin seems to be safe in patients with cirrhosis, and provides a survival benefit. Once hepatic malignancies are already established, metformin does not offer any therapeutic potential. Clinical trials and epidemiological studies of the benefit of metformin use for CCA should be conducted. To date, whether metformin as a prospective chemotherapeutic for CCA is still questionable and waits further atttention.

  5. Benefits and Effectiveness of Administering Pneumococcal Polysaccharide Vaccine With Seasonal Influenza Vaccine: An Approach for Policymakers

    PubMed Central

    Nanni, Angeline; Levine, Orin

    2012-01-01

    For the influenza pandemic of 2009–2010, countries responded to the direct threat of influenza but may have missed opportunities and strategies to limit secondary pneumococcal infections. Delivering both vaccines together can potentially increase pneumococcal polysaccharide vaccine (PPV23) immunization rates and prevent additional hospitalizations and mortality in the elderly and other high-risk groups. We used PubMed to review the literature on the concomitant use of PPV23 with seasonal influenza vaccines. Eight of 9 clinical studies found that a concomitant program conferred clinical benefits. The 2 studies that compared the cost-effectiveness of different strategies found concomitant immunization to be more cost-effective than either vaccine given alone. Policymakers should consider a stepwise strategy to reduce the burden of secondary pneumococcal infections during seasonal and pandemic influenza outbreaks. PMID:22397339

  6. Genetic Tests:Clinical Validity and Clinical Utility

    PubMed Central

    Burke, Wylie

    2014-01-01

    When evaluating the appropriate use of new genetic tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient’s clinical status (clinical validity) and the risks and benefits resulting from test use (clinical utility). Genetic tests in current use vary in accuracy and potential to improve health outcomes, and these test properties may be influenced by testing technology and the clinical setting in which the test is used. This unit defines clinical validity and clinical utility, provides examples, and considers the implications of these test properties for clinical practice. PMID:24763995

  7. Adaptive radiotherapy in lung cancer: dosimetric benefits and clinical outcome

    PubMed Central

    Kataria, T; Bisht, S S; Goyal, S; Pushpan, L; Abhishek, A; Govardhan, HB; Kumar, V; Sharma, K; Jain, S; Basu, T; Srivastava, A

    2014-01-01

    Objective: Anatomical changes during radiotherapy (RT) might introduce discrepancies between planned and delivered doses. This study evaluates the need for adaptive treatment in lung cancer RT. Methods: 15 patients with non-small-cell lung cancer, undergoing radical RT with or without concurrent chemotherapy, consecutively underwent planning CT scans at baseline and after 44–46 Gy. Target volumes were delineated on both scans. Phase I delivered 44–46 Gy to the initial planning target volume (PTV). Two Phase II plans for 16–20 Gy were developed on initial and mid-treatment scans, the treatment being delivered with the mid-treatment plan. The second CT structure set was fused with the initial scan data set using dose wash. Volumetric and dosimetric changes in target volumes and critical structures were assessed. Results: There was significant reduction in primary gross tumour volume (34.00%; p = 0.02) and PTV (34.70%; p < 0.01) in the second scan. In Plan 2, delivering the same dose to the initial PTV would have resulted in a significantly higher dose to the lung PTV (V20, 52.18%; V5, 21.76%; mean, 23.93%), contralateral lung (mean, 29.43%), heart (V10, 81.47%; V5, 56.62%; mean, 35.21%) and spinal cord (maximum dose, 37.53%). Conclusion: Treatment replanning can account for anatomical changes during RT and thereby enable better normal tissue sparing, while allowing radical target doses with the possibility of maximizing local control. Advances in knowledge: This study supports the sparse dosimetric data regarding the quantitative tumour volume reduction, re-emphasizing the need for adaptive replanning for minimizing normal tissue toxicity without compromising local control, and adds to the existing body of literature. PMID:24628269

  8. Clinical benefits of routine varicella vaccination for adults.

    PubMed

    Germinario, Cinzia; Gallone, Maria Serena; Cappelli, Maria Giovanna; Tafuri, Silvio

    2015-01-01

    Varicella is a highly contagious disease caused by varicella zoster virus. In children, it is generally a mild to moderate illness while it is often more severe in adults, with serious complications as dehydration, pneumonia, bleeding problems, infection or inflammation of the brain, secondary bacterial infections, sepsis, toxic shock syndrome, bone infections, joint infections and deaths. Some groups of adults are at major risk of complications, in particular immunocompromised persons as subjects with impaired humoral immunity and who is receiving systemic steroids, persons who live or work in environments in which transmission of varicella is likely, health-care personnel and pregnant women. After the introduction of Universal Mass Vaccination (UMV), the first mathematical models suggested that vaccination will lead to a shift in the average age at infection from children to adults with an increasing numbers of complicated forms, nevertheless new models predicted that, although an upward shift in the age at infection may occur, the overall morbidity due to varicella is likely to decrease. Current literature seems to suggest that for public health authorities the key action to prevent an increase of varicella incidence among adults is to achieve high vaccination coverage among babies and adolescents in countries who adopted UMV.

  9. Live surgery at conferences - Clinical benefits and ethical dilemmas.

    PubMed

    Philip-Watson, Joanna; Khan, Shahid A A; Hadjipavlou, Marios; Rane, Abhay; Knoll, Thomas

    2014-09-01

    Live surgical broadcasts (LSBs) are becoming increasingly popular in urological conferences. These activities can provide excellent training opportunities, as they allow the audience to view an operation conducted by world-renowned surgeons, and have the ability to interact with them in real time. However, several ethical considerations have been raised with this practice, which the participating surgeons and conference organisers must appreciate and address carefully. In this article we highlight the ethical considerations related to LSBs and advise on how these should be addressed. We also present the latest recommendations made by the European Association of Urology Live Surgery Committee and discuss alternatives to LSB.

  10. [Theoretical basis and clinical benefits of dry salt inhalation therapy].

    PubMed

    Endre, László

    2015-10-11

    Dry salt inhalation (halotherapy) reproduces the microclimate of salt caves, with beneficial effect on health. Sodium chloride crystals are disrupted into very small particles (with a diameter less than 3 µm), and this powder is artificially exhaled into the air of a comfortable room (its temperature is between 20-22 °C, and the relative humidity is low). The end-concentration of the salt in the air of the room will be between 10-30 mg/m(3). The sick (or healthy) persons spend 30-60 minutes in this room, usually 10-20 times. Due to the greater osmotic pressure the inhaled salt diminishes the oedema of the bronchial mucosa, decreases its inflammation, dissolves the mucus, and makes expectoration easier and faster (expectoration of air pollution and allergens will be faster, too). It inhibits the growth of bacteria and, in some case, kills them. Phagocyte activity is also increased. It has beneficial effect on the well being of the patients, and a relaxation effect on the central nervous system. It can prevent, or at least decrease the frequency of the respiratory tract inflammations. It produces better lung function parameters, diminishes bronchial hyperreactivity, which is the sign of decreasing inflammation. Its beneficial effect is true not only in inflammation of the lower respiratory tract, but also in acute or chronic upper airways inflammations. According to the international literature it has beneficial effect for some chronic dermatological disease, too, such as psoriasis, pyoderma and atopic dermatitis. This treatment (called as Indisó) is available under medical control in Hungary, too.

  11. [Theoretical basis and clinical benefits of dry salt inhalation therapy].

    PubMed

    Endre, László

    2015-10-11

    Dry salt inhalation (halotherapy) reproduces the microclimate of salt caves, with beneficial effect on health. Sodium chloride crystals are disrupted into very small particles (with a diameter less than 3 µm), and this powder is artificially exhaled into the air of a comfortable room (its temperature is between 20-22 °C, and the relative humidity is low). The end-concentration of the salt in the air of the room will be between 10-30 mg/m(3). The sick (or healthy) persons spend 30-60 minutes in this room, usually 10-20 times. Due to the greater osmotic pressure the inhaled salt diminishes the oedema of the bronchial mucosa, decreases its inflammation, dissolves the mucus, and makes expectoration easier and faster (expectoration of air pollution and allergens will be faster, too). It inhibits the growth of bacteria and, in some case, kills them. Phagocyte activity is also increased. It has beneficial effect on the well being of the patients, and a relaxation effect on the central nervous system. It can prevent, or at least decrease the frequency of the respiratory tract inflammations. It produces better lung function parameters, diminishes bronchial hyperreactivity, which is the sign of decreasing inflammation. Its beneficial effect is true not only in inflammation of the lower respiratory tract, but also in acute or chronic upper airways inflammations. According to the international literature it has beneficial effect for some chronic dermatological disease, too, such as psoriasis, pyoderma and atopic dermatitis. This treatment (called as Indisó) is available under medical control in Hungary, too. PMID:26551167

  12. Live surgery at conferences - Clinical benefits and ethical dilemmas.

    PubMed

    Philip-Watson, Joanna; Khan, Shahid A A; Hadjipavlou, Marios; Rane, Abhay; Knoll, Thomas

    2014-09-01

    Live surgical broadcasts (LSBs) are becoming increasingly popular in urological conferences. These activities can provide excellent training opportunities, as they allow the audience to view an operation conducted by world-renowned surgeons, and have the ability to interact with them in real time. However, several ethical considerations have been raised with this practice, which the participating surgeons and conference organisers must appreciate and address carefully. In this article we highlight the ethical considerations related to LSBs and advise on how these should be addressed. We also present the latest recommendations made by the European Association of Urology Live Surgery Committee and discuss alternatives to LSB. PMID:26019946

  13. Risk-benefit assessment of tocolytic drugs.

    PubMed

    Wischnik, A

    1991-01-01

    beta 2-Mimetics are the principal agents used for myometrial relaxation. As all the available drugs also have beta 1-stimulant effects, the various side effects (cardiovascular, pulmonary and metabolic) require a critical consideration of the clinical indications, thorough supervision and combined therapeutic concepts. With regard to clinical indications, 'prophylactic tocolysis' frequently turns out to be unnecessary, as does the treatment of physiological uterine contractions during pregnacy which have no effect on the cervix. The benefit of tocolysis must be seen not so much in a reduction of preterm labour but in enabling the obstetrician and neonatologist to optimise the handling of the premature baby, e.g. by allowing lung maturation or by enabling the patient to reach a centre for perinatal medicine before the birth. Labour-dependent fetal distress situations during birth at term can also be managed successfully. Supervision involves thorough control of both mother (especially of cardiovascular and metabolic parameters, electrolyte and water balance) and fetus (cardiotocography, fetometry) in order to decide individually when possible benefits are outweighed by maternal or fetal risks. Combination of beta 2-mimetic treatment with magnesium therapy reduces the beta-mimetic dosage required, has a cardioprotective action, and reduces the development of drug tolerance and the risk of lung oedema. This combination, therefore, should become routine in tocolytic therapy. If further protection against cardiovascular and risk of lung oedema is required, administration of beta 1-blockers is advisable.

  14. Sildenafil: two decades of benefits or risks?

    PubMed

    Leoni, Luís Antônio B; Leite, Gerson S; Wichi, Rogério B; Rodrigues, Bruno

    2013-09-01

    Sildenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). A patent was registered for this drug in 1990, which expired in 2010. Since expiration, the drug has been marketed under various trade names or as generic drugs. Numerous clinical trials have been conducted addressing the effectiveness of the drug for erectile dysfunction (ED) and its safety regarding the presence or absence of specific comorbidities. After over 20 years in the market, we need to ask: has the scientific community reached a general consensus as to the overall efficacy and safety of the drug? Can we firmly state that the benefits of the drug outweigh its risks? This review suggests that sildenafil is an effective and easily manageable treatment for erectile dysfunction, both in the absence and in the presence of comorbidities. After two decades of the emergence of sildenafil as a drug of choice for the treatment of ED (and the numerous studies and clinical trials undertaken during this time span), it is now possible to state that the benefits of the drug do outweigh the risks, and represent an significant improvement in the quality of life in men with ED. PMID:23758451

  15. Benefits for Children with Disabilities

    MedlinePlus

    ... Social Security . . . 3 Introduction. . . . . . . . . . . . . . . 4 Supplemental Security Income ( SSI) payments for children with disabilities. . . . . 4 Social Security ... for adults disabled since childhood. . . . . 10 Applying for SSI payments or SSDI benefits and how you can ...

  16. Employee Benefit Reporting After ERISA

    ERIC Educational Resources Information Center

    Steen, Wesley W.

    1976-01-01

    The statutory reporting requirements of ERISA and some of the regulations recently promulgated are discussed. All type of employee benefit plans are covered. For journal availability see HE 508 741. (LBH)

  17. 76 FR 21252 - Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-15

    ... From the Federal Register Online via the Government Publishing Office PENSION BENEFIT GUARANTY... Paying Benefits AGENCY: Pension Benefit Guaranty Corporation. ACTION: Final rule. SUMMARY: This final rule amends Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated...

  18. Food biotechnology: benefits and concerns.

    PubMed

    Falk, Michael C; Chassy, Bruce M; Harlander, Susan K; Hoban, Thomas J; McGloughlin, Martina N; Akhlaghi, Amin R

    2002-06-01

    Recent advances in agricultural biotechnology have highlighted the need for experimental evidence and sound scientific judgment to assess the benefits and risks to society. Nutrition scientists and other animal biologists need a balanced understanding of the issues to participate in this assessment. To date most modifications to crop plants have benefited producers. Crops have been engineered to decrease pesticide and herbicide usage, protect against stressors, enhance yields and extend shelf life. Beyond the environmental benefits of decreased pesticide and herbicide application, consumers stand to benefit by development of food crops with increased nutritional value, medicinal properties, enhanced taste and esthetic appeal. There remains concern that these benefits come with a cost to the environment or increased risk to the consumer. Most U.S. consumers are not aware of the extent that genetically modified foods have entered the marketplace. Consumer awareness of biotechnology seems to have increased over the last decade, yet most consumers remain confused over the science. Concern over the impact on the safety of the food supply remains low in the United States, but is substantially elevated in Europe. Before a genetically engineered crop is introduced into commerce it must pass regulatory scrutiny by as many as four different federal regulatory bodies to ensure a safe food supply and minimize the risk to the environment. Key areas for more research are evaluation of the nutritional benefits of new crops, further investigation of the environmental impact, and development of better techniques to identify and track genetically engineered products.

  19. The good-genes and compatible-genes benefits of mate choice.

    PubMed

    Puurtinen, Mikael; Ketola, Tarmo; Kotiaho, J S

    2009-11-01

    Genetic benefits from mate choice could be attained by choosing mates with high heritable quality ("good genes") and that are genetically compatible ("compatible genes"). We clarify the conceptual and empirical framework for estimating genetic benefits of mate choice, stressing that benefits must be measured from offspring fitness because there are no unequivocal surrogates for genetic quality of individuals or for compatibility of parents. We detail the relationship between genetic benefits and additive and nonadditive genetic variance in fitness, showing that the benefits have been overestimated in previous verbal treatments. We point out that additive benefits readily arise from nonadditive gene action and that the idea of "heritable nonadditive benefits" is a misconception. We review the empirical evidence of the magnitude of benefits of good genes and compatible genes in animal populations, and we outline the most promising future directions for empirical research on the genetic benefits of mate choice. PMID:19772439

  20. Benefit versus risk in statin treatment.

    PubMed

    Guyton, John R

    2006-04-17

    The Statin Safety Assessment Conference of the National Lipid Association (NLA), reported in this supplement to The American Journal of Cardiology, provides a comprehensive evaluation of old and new experience on adverse events associated with the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins. To place these in context, one can express both the risk of side effects and the benefits for cardiovascular disease in terms of events per person-year of statin treatment. The mortality risk from fatal rhabdomyolysis is approximately 0.3 per 100,000 person-years, and the risks of nonfatal rhabdomyolysis and of putative statin-attributable peripheral neuropathy are approximately 3 and 12 events, respectively, per 100,000 person-years. Reports of acute liver failure and acute or chronic kidney disease give lower rate estimates that, even when corrected for underreporting, are approximately equal to the background rates of these conditions in the general population, lending scant support for statin-attributable etiology. In contrast, the benefit of statin use is to avert several hundred deaths and several hundred cases each of heart and brain infarction per 100,000 person-years in appropriately treated high-risk patients. Although population estimates such as these are useful, they must be translated repeatedly to individual patient-provider encounters, where clinical skill and art must combine with scientific evidence. The continued publication of individual case reports and small randomized trials among groups of patients with potential side effects should be encouraged. Statins should not be used in situations where minimal benefit is expected, as safety data and risk-benefit analysis must be meshed with guidelines that help the clinician decide whom to treat and how aggressively to treat.

  1. Benefit versus risk in statin treatment.

    PubMed

    Guyton, John R

    2006-04-17

    The Statin Safety Assessment Conference of the National Lipid Association (NLA), reported in this supplement to The American Journal of Cardiology, provides a comprehensive evaluation of old and new experience on adverse events associated with the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins. To place these in context, one can express both the risk of side effects and the benefits for cardiovascular disease in terms of events per person-year of statin treatment. The mortality risk from fatal rhabdomyolysis is approximately 0.3 per 100,000 person-years, and the risks of nonfatal rhabdomyolysis and of putative statin-attributable peripheral neuropathy are approximately 3 and 12 events, respectively, per 100,000 person-years. Reports of acute liver failure and acute or chronic kidney disease give lower rate estimates that, even when corrected for underreporting, are approximately equal to the background rates of these conditions in the general population, lending scant support for statin-attributable etiology. In contrast, the benefit of statin use is to avert several hundred deaths and several hundred cases each of heart and brain infarction per 100,000 person-years in appropriately treated high-risk patients. Although population estimates such as these are useful, they must be translated repeatedly to individual patient-provider encounters, where clinical skill and art must combine with scientific evidence. The continued publication of individual case reports and small randomized trials among groups of patients with potential side effects should be encouraged. Statins should not be used in situations where minimal benefit is expected, as safety data and risk-benefit analysis must be meshed with guidelines that help the clinician decide whom to treat and how aggressively to treat. PMID:16581337

  2. Sewage sludge additive

    NASA Technical Reports Server (NTRS)

    Kalvinskas, J. J.; Mueller, W. A.; Ingham, J. D. (Inventor)

    1980-01-01

    The additive is for a raw sewage treatment process of the type where settling tanks are used for the purpose of permitting the suspended matter in the raw sewage to be settled as well as to permit adsorption of the dissolved contaminants in the water of the sewage. The sludge, which settles down to the bottom of the settling tank is extracted, pyrolyzed and activated to form activated carbon and ash which is mixed with the sewage prior to its introduction into the settling tank. The sludge does not provide all of the activated carbon and ash required for adequate treatment of the raw sewage. It is necessary to add carbon to the process and instead of expensive commercial carbon, coal is used to provide the carbon supplement.

  3. Perspectives on Additive Manufacturing

    NASA Astrophysics Data System (ADS)

    Bourell, David L.

    2016-07-01

    Additive manufacturing (AM) has skyrocketed in visibility commercially and in the public sector. This article describes the development of this field from early layered manufacturing approaches of photosculpture, topography, and material deposition. Certain precursors to modern AM processes are also briefly described. The growth of the field over the last 30 years is presented. Included is the standard delineation of AM technologies into seven broad categories. The economics of AM part generation is considered, and the impacts of the economics on application sectors are described. On the basis of current trends, the future outlook will include a convergence of AM fabricators, mass-produced AM fabricators, enabling of topology optimization designs, and specialization in the AM legal arena. Long-term developments with huge impact are organ printing and volume-based printing.

  4. Sarks as additional fermions

    NASA Astrophysics Data System (ADS)

    Agrawal, Jyoti; Frampton, Paul H.; Jack Ng, Y.; Nishino, Hitoshi; Yasuda, Osamu

    1991-03-01

    An extension of the standard model is proposed. The gauge group is SU(2) X ⊗ SU(3) C ⊗ SU(2) S ⊗ U(1) Q, where all gauge symmetries are unbroken. The colour and electric charge are combined with SU(2) S which becomes strongly coupled at approximately 500 GeV and binds preons to form fermionic and vector bound states. The usual quarks and leptons are singlets under SU(2) X but additional fermions, called sarks. transform under it and the electroweak group. The present model explains why no more than three light quark-lepton families can exist. Neutral sark baryons, called narks, are candidates for the cosmological dark matter having the characteristics designed for WIMPS. Further phenomenological implications of sarks are analyzed i including electron-positron annihilation. Z 0 decay, flavor-changing neutral currents. baryon-number non-conservation, sarkonium and the neutron electric dipole moment.

  5. Improving stroke outcome: the benefits of increasing availability of technology.

    PubMed Central

    Heller, R. F.; Langhorne, P.; James, E.

    2000-01-01

    INTRODUCTION: A decision analysis was performed to explore the potential benefits of interventions to improve the outcome of patients admitted to hospital with a stroke, in the context of the technology available in different parts of the world. METHODS: The outcome of death or dependency was used with a six-month end-point. RESULTS: Four settings were identified that would depend on the resources available. The proportion of stroke patients who were dead or dependent at six months was 61.5% with no intervention at all. Setting 4, with the only intervention being the delayed introduction of aspirin, produced a 0.5% absolute improvement in outcome (death or dependency), and the addition of an organized stroke unit (Setting 3) produced the largest incremental improvement, of 2.7%. Extra interventions associated with non-urgent computed tomography and thus the ability to avoid anticoagulation or aspirin for those with a haemorrhagic stroke (Setting 2), and immediate computed tomography scanning to allow the use of thrombolytics in non-haemorrhagic stroke (Setting 1), produced only small incremental benefits of 0.4% in each case. DISCUSSION: To reduce the burden of illness due to stroke, efforts at primary prevention are essential and likely to have a greater impact than even the best interventions after the event. In the absence of good primary prevention, whatever is possible must be done to reduce the sequelae of stroke. This analysis provides a rational basis for beginning the development of clinical guidelines applicable to the economic setting of the patient. PMID:11143194

  6. Benefits and drawbacks of electronic health record systems

    PubMed Central

    Menachemi, Nir; Collum, Taleah H

    2011-01-01

    The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 that was signed into law as part of the “stimulus package” represents the largest US initiative to date that is designed to encourage widespread use of electronic health records (EHRs). In light of the changes anticipated from this policy initiative, the purpose of this paper is to review and summarize the literature on the benefits and drawbacks of EHR systems. Much of the literature has focused on key EHR functionalities, including clinical decision support systems, computerized order entry systems, and health information exchange. Our paper describes the potential benefits of EHRs that include clinical outcomes (eg, improved quality, reduced medical errors), organizational outcomes (eg, financial and operational benefits), and societal outcomes (eg, improved ability to conduct research, improved population health, reduced costs). Despite these benefits, studies in the literature highlight drawbacks associated with EHRs, which include the high upfront acquisition costs, ongoing maintenance costs, and disruptions to workflows that contribute to temporary losses in productivity that are the result of learning a new system. Moreover, EHRs are associated with potential perceived privacy concerns among patients, which are further addressed legislatively in the HITECH Act. Overall, experts and policymakers believe that significant benefits to patients and society can be realized when EHRs are widely adopted and used in a “meaningful” way. PMID:22312227

  7. Additive lattice kirigami

    PubMed Central

    Castle, Toen; Sussman, Daniel M.; Tanis, Michael; Kamien, Randall D.

    2016-01-01

    Kirigami uses bending, folding, cutting, and pasting to create complex three-dimensional (3D) structures from a flat sheet. In the case of lattice kirigami, this cutting and rejoining introduces defects into an underlying 2D lattice in the form of points of nonzero Gaussian curvature. A set of simple rules was previously used to generate a wide variety of stepped structures; we now pare back these rules to their minimum. This allows us to describe a set of techniques that unify a wide variety of cut-and-paste actions under the rubric of lattice kirigami, including adding new material and rejoining material across arbitrary cuts in the sheet. We also explore the use of more complex lattices and the different structures that consequently arise. Regardless of the choice of lattice, creating complex structures may require multiple overlapping kirigami cuts, where subsequent cuts are not performed on a locally flat lattice. Our additive kirigami method describes such cuts, providing a simple methodology and a set of techniques to build a huge variety of complex 3D shapes. PMID:27679822

  8. Additive lattice kirigami

    PubMed Central

    Castle, Toen; Sussman, Daniel M.; Tanis, Michael; Kamien, Randall D.

    2016-01-01

    Kirigami uses bending, folding, cutting, and pasting to create complex three-dimensional (3D) structures from a flat sheet. In the case of lattice kirigami, this cutting and rejoining introduces defects into an underlying 2D lattice in the form of points of nonzero Gaussian curvature. A set of simple rules was previously used to generate a wide variety of stepped structures; we now pare back these rules to their minimum. This allows us to describe a set of techniques that unify a wide variety of cut-and-paste actions under the rubric of lattice kirigami, including adding new material and rejoining material across arbitrary cuts in the sheet. We also explore the use of more complex lattices and the different structures that consequently arise. Regardless of the choice of lattice, creating complex structures may require multiple overlapping kirigami cuts, where subsequent cuts are not performed on a locally flat lattice. Our additive kirigami method describes such cuts, providing a simple methodology and a set of techniques to build a huge variety of complex 3D shapes.

  9. A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

    ERIC Educational Resources Information Center

    Kerson, Cynthia

    2013-01-01

    Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large…

  10. Removable partial denture design using milled abutment surfaces and minimal soft tissue coverage for periodontally compromised teeth: a clinical report.

    PubMed

    Chaiyabutr, Yada; Brudvik, James S

    2008-04-01

    This clinical report describes the treatment of a partially edentulous patient with periodontally compromised teeth using a combination of single crowns and a removable partial denture (RPD). The RPD was designed to combine the benefits of milled surfaces and hygienic principles while allowing modification and addition of artificial teeth, should natural teeth be lost.

  11. Incidental Findings in Imaging Research: Evaluating Incidence, Benefit and Burden

    PubMed Central

    Orme, Nicholas M.; Fletcher, Joel G.; Siddiki, Hassan A.; Harmsen, W. Scott; O’Byrne, Megan M.; Port, John D.; Tremaine, William J.; Pitot, Henry C.; McFarland, Beth; Robinson, Marguerite E.; Koenig, Barabara A.; King, Bernard F.; Wolf, Susan M.

    2013-01-01

    Context Little information exists concerning the frequency of clinically significant incidental findings (IFs) identified in the course of imaging research across a broad spectrum of imaging modalities and body regions. Objective To estimate the frequency with which research imaging IFs generate further clinical action, and the medical benefit/burden of identifying these IFs. Design, Setting, and Participants Retrospective review of subjects undergoing a research imaging exam that was interpreted by a radiologist for IFs in the first quarter of 2004, with 3-year clinical follow-up. An expert panel reviewed IFs generating clinical action to determine medical benefit/burden based on predefined criteria. Main Outcome Measures Frequency of (1) IFs that generated further clinical action by modality, body part, age, gender, and (2) IFs resulting in clear medical benefit or burden. Results 1376 patients underwent 1426 research imaging studies. 40% (567/1426) of exams had at least one IF (1055 total). Risk of an IF increased significantly by age (OR=1.5; [1.4–1.7=95% C.I.] per decade increase). Abdominopelvic CT generated more IFs than other exams (OR=18.9 compared with ultrasound; 9.2% with subsequent clinical action), with CT Thorax and MR brain next (OR=11.9 and 5.9; 2.8% and 2.2% with action, respectively). Overall 6.2% of exams (35/567) with an IF generated clinical action, resulting in clear medical benefit in 1.1% (6/567) and clear medical burden in 0.5% (3/567). In most instances, medical benefit/burden was unclear (4.6%; 26/567). Conclusions The frequency of IFs in imaging research exams varies significantly by imaging modality, body region and age. Research imaging studies at high risk for generating IFs can be identified. Routine evaluation of research images by radiologists may result in identification of IFs in a substantial number of cases and subsequent clinical action to address them in much smaller number. Such clinical action can result in medical

  12. PAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer.

    PubMed

    Martín, Miguel; Prat, Aleix; Rodríguez-Lescure, Alvaro; Caballero, Rosalía; Ebbert, Mark T W; Munárriz, Blanca; Ruiz-Borrego, Manuel; Bastien, Roy R L; Crespo, Carmen; Davis, Carole; Rodríguez, César A; López-Vega, José M; Furió, Vicente; García, Ana M; Casas, Maribel; Ellis, Matthew J; Berry, Donald A; Pitcher, Brandelyn N; Harris, Lyndsay; Ruiz, Amparo; Winer, Eric; Hudis, Clifford; Stijleman, Inge J; Tuck, David P; Carrasco, Eva; Perou, Charles M; Bernard, Philip S

    2013-04-01

    To identify a group of patients who might benefit from the addition of weekly paclitaxel to conventional anthracycline-containing chemotherapy as adjuvant therapy of node-positive operable breast cancer. The predictive value of PAM50 subtypes and the 11-gene proliferation score contained within the PAM50 assay were evaluated in 820 patients from the GEICAM/9906 randomized phase III trial comparing adjuvant FEC to FEC followed by weekly paclitaxel (FEC-P). Multivariable Cox regression analyses of the secondary endpoint of overall survival (OS) were performed to determine the significance of the interaction between treatment and the (1) PAM50 subtypes, (2) PAM50 proliferation score, and (3) clinical and pathological variables. Similar OS analyses were performed in 222 patients treated with weekly paclitaxel versus paclitaxel every 3 weeks in the CALGB/9342 and 9840 metastatic clinical trials. In GEICAM/9906, with a median follow up of 8.7 years, OS of the FEC-P arm was significantly superior compared to the FEC arm (unadjusted HR = 0.693, p = 0.013). A benefit from paclitaxel was only observed in the group of patients with a low PAM50 proliferation score (unadjusted HR = 0.23, p < 0.001; and interaction test, p = 0.006). No significant interactions between treatment and the PAM50 subtypes or the various clinical-pathological variables, including Ki-67 and histologic grade, were identified. Finally, similar OS results were obtained in the CALGB data set, although the interaction test did not reach statistical significance (p = 0.109). The PAM50 proliferation score identifies a subset of patients with a low proliferation status that may derive a larger benefit from weekly paclitaxel.

  13. 42 CFR 410.3 - Scope of benefits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... physical therapy and speech pathology services, rural health clinic services, Federally qualified health... community mental health centers (CMHCs). (3) Other medicial services, equipment, and supplies that are not... 42 Public Health 2 2012-10-01 2012-10-01 false Scope of benefits. 410.3 Section 410.3...

  14. 42 CFR 410.3 - Scope of benefits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... physical therapy and speech pathology services, rural health clinic services, Federally qualified health... community mental health centers (CMHCs). (3) Other medicial services, equipment, and supplies that are not... 42 Public Health 2 2013-10-01 2013-10-01 false Scope of benefits. 410.3 Section 410.3...

  15. 42 CFR 68a.15 - Additional conditions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Additional conditions. 68a.15 Section 68a.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES FELLOWSHIPS, INTERNSHIPS, TRAINING NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS...

  16. 42 CFR 68a.15 - Additional conditions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Additional conditions. 68a.15 Section 68a.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES FELLOWSHIPS, INTERNSHIPS, TRAINING NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS...

  17. First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 4: pre-clinical efficacy and complication data required to justify a clinical trial.

    PubMed

    Cooper, David K C; Bottino, Rita; Gianello, Pierre; Graham, Melanie; Hawthorne, Wayne J; Kirk, Allan D; Korsgren, Olle; Park, Chung-Gyu; Weber, Collin

    2016-01-01

    In 2009, the International Xenotransplantation Association (IXA) published a consensus document that provided guidelines and "recommendations" (not regulations) for those contemplating clinical trials of porcine islet transplantation. These guidelines included the IXA's opinion on what constituted "rigorous pre-clinical studies using the most relevant animal models" and were based on "non-human primate testing." We now report our discussion following a careful review of the 2009 guidelines as they relate to pre-clinical testing. In summary, we do not believe there is a need to greatly modify the conclusions and recommendations of the original consensus document. Pre-clinical studies should be sufficiently rigorous to provide optimism that a clinical trial is likely to be safe and has a realistic chance of success, but need not be so demanding that success might only be achieved by very prolonged experimentation, as this would not be in the interests of patients whose quality of life might benefit immensely from a successful islet xenotransplant. We believe these guidelines will be of benefit to both investigators planning a clinical trial and to institutions and regulatory authorities considering a proposal for a clinical trial. In addition, we suggest consideration should be given to establishing an IXA Clinical Trial Advisory Committee that would be available to advise (but not regulate) researchers considering initiating a clinical trial of xenotransplantation. PMID:26916706

  18. Incremental Benefits and Cost of Coordinated Anxiety Learning and Management for Anxiety Treatment in Primary Care

    PubMed Central

    Joesch, Jutta M.; Sherbourne, Cathy D.; Sullivan, Greer; Stein, Murray B.; Craske, Michelle G.; Roy-Byrne, Peter

    2012-01-01

    Background Improving the quality of mental health care requires integrating successful research interventions into “real-world” practice settings. Coordinated Anxiety Learning and Management (CALM) is a treatment-delivery model for anxiety disorders encountered in primary care. CALM offers cognitive behavioral therapy (CBT), medication, or both; non-expert care managers assisting primary care clinicians with adherence promotion and medication optimization; computer-assisted CBT delivery; and outcome monitoring. This study describes incremental benefits, costs, and net benefits of CALM versus usual care. Methods The CALM randomized, controlled effectiveness trial was conducted in 17 primary care clinics in 4 US cities from 2006 to 2009. Of 1,062 eligible patients, 1,004 English- or Spanish-speaking patients age 18–75 years with panic, generalized anxiety, social anxiety, and/or posttraumatic stress disorder with or without major depression were randomized. Anxiety-free days, quality-adjusted life years (QALYs), and expenditures for outpatient visits, emergency room visits, inpatient stays, and psychiatric medications were estimated based on blinded telephone assessments at baseline, 6, 12, and 18 months. Results Over 18 months, CALM participants, on average, experienced 57.1 more anxiety-free days [95% confidence interval (CI) 31–83] and $245 additional medical expenses (95% CI $ −733 to $1,223). The mean incremental net benefit of CALM versus usual care was positive when an anxiety-free day was valued ≥ $4. For QALYs based on the Short-Form Health Survey-12 and the EQ-5D the mean incremental net benefit was positive at ≥ $5,000. Conclusions Compared with usual care, CALM provides significant benefits with modest increases in health care expenditures. PMID:22152230

  19. 31 CFR 29.343 - Disability benefits.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Disability benefits. 29.343 Section... Federal Benefit Payments § 29.343 Disability benefits. (a) The general rule that Federal Benefit Payments... retirement and separated on June 30, 1997, does not apply to disability benefits prior to optional...

  20. 31 CFR 29.343 - Disability benefits.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance: Treasury 1 2012-07-01 2012-07-01 false Disability benefits. 29.343 Section... Federal Benefit Payments § 29.343 Disability benefits. (a) The general rule that Federal Benefit Payments... retirement and separated on June 30, 1997, does not apply to disability benefits prior to optional...