Terrorists on Trial: A Performative Perspective

Directory of Open Access Journals (Sweden)

Beatrice de Graaf

2011-03-01

Full Text Available On 30 March 2011, ICCT organised an Expert Meeting entitled “Terrorism Trials as Theatre: A Performative Perspective”. The Expert Meeting applied a performative perspective to three well known and recent trials in different parts of the world: the trials against the Dutch Hofstad Group, the Mumbai 2008 Terrorist Attack Trial and the Guantanamo Military Tribunals. As such, the Expert Meeting did not concentrate solely on the immediate judicial performance of the magistrates and/or the defence; instead, the trials were put in their wider sociological context, adopting notions of social drama and communication sciences. This Expert Meeting Paper is a further adaptation of the Discussion Paper that was used as basis for debate during the Meeting.

Wellness through a comprehensive Yogic breathing program – A controlled pilot trial

Directory of Open Access Journals (Sweden)

Norlander Torsten

2007-12-01

developed here is safe, compliance level is good, and a full scale trial is feasible. The data obtained suggest that adult participants may improve their wellness by learning and applying a program based on yoga and yogic breathing exercises; this can be conclusively assessed in a large-scale trial. Trial Registration Australian Clinical Trial Registry ACTRN012607000175471.

Radiative transfer in spherical circumstellar dust envelopes. III. Dust envelope models of some well known infrared stars

International Nuclear Information System (INIS)

Apruzese, J.P.

1975-01-01

The radiative transfer techniques described elsewhere by the author have been employed to construct dust envelope models of several well known infrared stars. The resulting calculations indicate that the infrared emissivity of circumstellar grains generally must be higher than that which many calculations of small nonsilicate grains yield. This conclusion is dependent to some degree on the (unknown) size of the stellar envelopes considered, but is quite firm in the case of the spatially resolved envelope of IRC+10216. Further observations of the spatial distribution of the infrared radiation from stellar envelopes will be invaluable in deciphering the properties of the circumstellar grains

Efficacy of the Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: a Randomized Controlled Trial.

Science.gov (United States)

Myers, Nicholas D; Prilleltensky, Isaac; Prilleltensky, Ora; McMahon, Adam; Dietz, Samantha; Rubenstein, Carolyn L

2017-11-01

Subjective well-being refers to people's level of satisfaction with life as a whole and with multiple dimensions within it. Interventions that promote subjective well-being are important because there is evidence that physical health, mental health, substance use, and health care costs may be related to subjective well-being. Fun For Wellness (FFW) is a new online universal intervention designed to promote growth in multiple dimensions of subjective well-being. The purpose of this study was to provide an initial evaluation of the efficacy of FFW to increase subjective well-being in multiple dimensions in a universal sample. The study design was a prospective, double-blind, parallel group randomized controlled trial. Data were collected at baseline and 30 and 60 days-post baseline. A total of 479 adult employees at a major university in the southeast of the USA were enrolled. Recruitment, eligibility verification, and data collection were conducted online. Measures of interpersonal, community, occupational, physical, psychological, economic (i.e., I COPPE), and overall subjective well-being were constructed based on responses to the I COPPE Scale. A two-class linear regression model with complier average causal effect estimation was imposed for each dimension of subjective well-being. Participants who complied with the FFW intervention had significantly higher subjective well-being, as compared to potential compliers in the Usual Care group, in the following dimensions: interpersonal at 60 days, community at 30 and 60 days, psychological at 60 days, and economic at 30 and 60 days. Results from this study provide some initial evidence for both the efficacy of, and possible revisions to, the FFW intervention.

Staying well after depression: trial design and protocol

Directory of Open Access Journals (Sweden)

Duggan Danielle S

2010-03-01

Full Text Available Abstract Background Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group. Methods/Design This trial compares Mindfulness-Based Cognitive Therapy (MBCT, a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE, an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU. It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter. Discussion This will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent

THE FORTIFIED CHURCHES FROM TRANSYLVANIA - HOW WELL ARE THEY KNOWN BY THE ROMANIAN CITIZENS?

Directory of Open Access Journals (Sweden)

Serb Silvana Valentina

2011-12-01

Full Text Available The Fortified Churches from Transylvania represent an important category of historical and religious sights of the anthropic touristic potential - historic cultural potential of this region. However, they are not exploited from a touristic point of view at their fair value, one reason being the weak promoting activity, especially the lack of information among citizens about the existence of these churches. In this paper, I intend to highlight on the information level awareness among the Romanian citizens regarding the existence of these churches, to identify which are the most well known and visited churches and to establish the profile of those who visit the churches. In the end, the results of this research impose a set of measures to improve the level of information among the Romanian citizens concerning the existence of this historic and religious heritage. The paper is relevant for the doctoral research project called Marketing Places - religious and historical sights of touristic interest from Transylvania under the guidance of Professor Doctor Marius Pop, Babes-Bolyai University of Cluj-Napoca, Faculty of Economics and Business Administration, during 1st of October 2009 - 1st of October 2012.

All Known Water Wells in the State of Iowa (Public Version)

Data.gov (United States)

Iowa State University GIS Support and Research Facility — Combined database of all wells with uniform attributes from detailed individual well databases (see General and Entity Attribute sections of metadata for individual...

Financial Development and Economic Growth: Known Knowns, Known Unknowns, and Unknown Unknowns

OpenAIRE

Ugo Panizza

2014-01-01

This paper summarizes the main findings of the literature on the relationship between financial and economic development (the known knowns), points to directions for future research (the known unknowns), and then speculates on the third Rumsfeldian category. The known knowns section organizes the empirical literature on finance and growth into three strands: (i) the traditional literature which established the link between finance and growth; (ii) the new literature which qualified some of th...

Extensive gaps and biases in our knowledge of a well-known fauna: Implications for integrating biological traits into macroecology

KAUST Repository

Tyler, Elizabeth

2011-12-09

Aim Ecologists seeking to describe patterns at ever larger scales require compilations of data on the global abundance and distribution of species. Comparable compilations of biological data are needed to elucidate the mechanisms behind these patterns, but have received far less attention. We assess the availability of biological data across an entire assemblage: the well-documented demersal marine fauna of the United Kingdom. We also test whether data availability for a species depends on its taxonomic group, maximum body size, the number of times it has been recorded in a global biogeographic database, or its commercial and conservation importance. Location Seas of the United Kingdom. Methods We defined a demersal marine fauna of 973 species from 15 phyla and 40 classes using five extensive surveys around the British Isles. We then quantified the availability of data on eight key biological traits (termed biological knowledge) for each species from online databases. Relationships between biological knowledge and our predictors were tested with generalized linear models. Results Full data on eight fundamental biological traits exist for only 9% (n= 88) of the UK demersal marine fauna, and 20% of species completely lack data. Clear trends in our knowledge exist: fish (median biological knowledge score = six traits) are much better known than invertebrates (one trait). Biological knowledge increases with biogeographic knowledge and (to a lesser extent) with body size, and is greater in species that are commercially exploited or of conservation concern. Main conclusions Our analysis reveals deep ignorance of the basic biology of a well-studied fauna, highlighting the need for far greater efforts to compile biological trait data. Clear biases in our knowledge, relating to how well sampled or \\'important\\' species are suggests that caution is required in extrapolating small subsets of biologically well-known species to ecosystem-level studies. © 2011 Blackwell

Known knowns, known unknowns and unknown unknowns in prokaryotic transposition.

Science.gov (United States)

Siguier, Patricia; Gourbeyre, Edith; Chandler, Michael

2017-08-01

Although the phenomenon of transposition has been known for over 60 years, its overarching importance in modifying and streamlining genomes took some time to recognize. In spite of a robust understanding of transposition of some TE, there remain a number of important TE groups with potential high genome impact and unknown transposition mechanisms and yet others, only recently identified by bioinformatics, yet to be formally confirmed as mobile. Here, we point to some areas of limited understanding concerning well established important TE groups with DDE Tpases, to address central gaps in our knowledge of characterised Tn with other types of Tpases and finally, to highlight new potentially mobile DNA species. It is not exhaustive. Examples have been chosen to provide encouragement in the continued exploration of the considerable prokaryotic mobilome especially in light of the current threat to public health posed by the spread of multiple Ab R . Copyright © 2017 Elsevier Ltd. All rights reserved.

Are Well-Informed Potential Trial Participants More Likely to Participate?

Science.gov (United States)

de Oliveira, Lucas Lentini Herling; Vissoci, Joao Ricardo Nickenig; Machado, Wagner de Lara; Rodrigues, Clarissa G; Limkakeng, Alexander T

2017-12-01

Bearing in mind the importance of the informed consent, flaws in this process may be a barrier to participants' recruitment. Our objective was to determine the relationship between the degree of comprehension of the informed consent document plus the importance given to individual elements by potential participants of a hypothetical trial and their willingness to participate in such trials. We performed an Online Survey simulating an emergency department trial recruitment, posteriorly evaluating participants' ratings of importance and self-assessed comprehension of specific topics of the informed consent document. Only 10% of the sample read the entire document. Some specific topics were associated with willingness to participate in the hypothetical trial, but simple composite additive scores of comprehension and importance were not. We concluded that participants in general do not read the entire informed consent document and that importance given to specific topics may influence willingness to participate.

Trials and tribulations of a new regulation: coal bed methane water well testing

Energy Technology Data Exchange (ETDEWEB)

Lintott, D.; Swyngedouw, C.; Schneider, E. [Norwest Labs, Edmonton, AB (Canada); Lintott, D.; Swyngedouw, C.; Schneider, E. [Bodycote Testing Group, Toronto, ON (Canada)

2006-07-01

As of January 2006, coalbed methane (CBM) activity in Alberta was at 3600 producing wells with the potential for 25,000 to 50,000 wells. Coalbed methane risks and regulations were discussed. Regulatory initiatives, politics of coalbed methane, and a regulatory timeline was provided and the trials of a new regulation were presented. Other topics of discussion included: methane sampling and analysis; dissolved methane in water; gas isotopes; routine water potability; microbiology testing; and, sulfate reducing bacteria (SRB)/iron-related bacteria (IRB) method validation. The results of the microbial testing were presented. Although relatively few positive coliforms in wells were analyzed, most wells demonstrated positive presence for iron and sulfate bacteria. It was recommended that further research be conducted to evaluate the water sulfide concentration/turbidity, along with other parameters with presence and concentration of SRB and IRB bacteria as an indication of poor water quality. refs., tabs.

Innovative Therapeutic Potential of Cannabinoid Receptors as Targets in Alzheimer's disease and Less Well-Known Diseases.

Science.gov (United States)

Paez, Juan A; Campillo, Nuria E

2018-02-25

The discovery of cannabinoid receptors at the beginning of the 1990s, CB1 being cloned in 1990 and CB2 cloned in 1993, and the availability of selective and potent cannabimimetics could only be justified by the existence of endogenous ligands that are capable of binding to them. Thus, the characterisation and cloning of the first cannabinoid receptor (CB1) led to the isolation and characterisation of the first endocannabinoid, arachidonoylethanolamide (AEA), two years later and the subsequent identification of a family of lipid transmitters known as the fatty acid ester 2-arachidonoylglycerol (2-AG). The endogenous cannabinoid system is a complex signalling system that comprises transmembrane endocannabinoid receptors, their endogenous ligands (the endocannabinoids), the specific uptake mechanisms and the enzymatic systems related to their biosynthesis and degradation. The endocannabinoid system has been implicated in a wide diversity of biological processes, in both the central and peripheral nervous systems, including memory, learning, neuronal development, stress and emotions, food intake, energy regulation, peripheral metabolism, and the regulation of hormonal balance through the endocrine system. In this context, this article will review the current knowledge of the therapeutic potential of cannabinoid receptor as a target in Alzheimer's disease and other less well-known diseases that include, among others, multiple sclerosis, bone metabolism, and Fragile X syndrome. The therapeutic applications will be addressed through the study of cannabinoid agonists acting as single drugs and multi-target drugs highlighting the CB2 receptor agonist. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Ibuprofen 400 mg is effective in women, and women are well represented in trials

Directory of Open Access Journals (Sweden)

Moore R Andrew

2002-11-01

Full Text Available Abstract Background A recent article in the New Scientist argued that women were under-represented in clinical trials which, until now, had masked the finding that ibuprofen 400 mg was ineffective in women. Methods Meta-analysis of randomised, double-blind placebo-controlled trials of ibuprofen 400 mg in acute pain, and use of individual patient information were planned to test the hypothesis that ibuprofen is ineffective in women. For each trial the proportion of women participating, the number of patients with at least 50% pain relief and the overall event rate for ibuprofen 400 mg and placebo was calculated. For each patient percentage pain relief was calculated, and the numbers of women and men achieving at least 50% pain relief used to calculate number-needed-to-treat (NNT for ibuprofen 400 mg compared to placebo. Results Thirty-seven included trials had 3,577 patients, 67% of whom were women. The proportion with at least 50% pain relief was unaffected by how many women were included. In an analysis of 678 individual patients the proportion of women and men with at least 50% pain relief was the same, NNT 3.4 (2.6 to 4.6 and 2.5 (2.0 to 3.3 respectively. Conclusion There is no clinically meaningful difference in the efficacy of ibuprofen 400 mg between men and women experiencing moderate to severe postoperative pain and women were well represented.

Effects of sacred music on the spiritual well-being of bereaved relatives: a randomized clinical trial

Directory of Open Access Journals (Sweden)

Vladimir Araujo da Silva

2017-12-01

Full Text Available Abstract OBJECTIVE To evaluate the effects of instrumental sacred music and sacred music with vocals on the spiritual well-being of bereaved relatives. METHOD This is a randomized clinical trial carried out with family members bereaving the death of loved ones to cancer. Participants were allocated into three groups: Group 1 (control, Group 2 (experimental using sacred music with vocals or Group 3 (experimental using instrumental sacred music. Spiritual well-being was assessed through the Spiritual Well-Being Scale. RESULTS Sixty-nine (69 family members participated. Mean scores before and after the intervention indicated high levels of spiritual well-being (106.4 and 105.5 in Group 1; 103.2 and 105.2 in Group 2; 107.4 and 108.7 in Group 3 and religious well-being (57.9 and 56.9 in Group 1; 56.3 and 56.4 in Group 2; 57.4 and 58.1 in Group 3, and moderate levels of existential well-being (48.5 and 48.6 in Group 1; 46.9 and 48.9 in Group 2; 49.9 and 50.7 in Group 3, with the exception of Group 3 which presented a high level of existential well-being after the intervention. CONCLUSION The results show that there were no statistically significant differences in the spiritual well-being scores between the experimental groups and the control group. We evidence the need for further studies that use music therapy as a Nursing intervention for bereaved families. Brazilian Registry of Clinical Trials: RBR-2wtwjz.

Effects of sacred music on the spiritual well-being of bereaved relatives: a randomized clinical trial.

Science.gov (United States)

Silva, Vladimir Araujo da; Silva, Rita de Cássia Frederico; Cabau, Nubia Carla Ferreira; Leão, Eliseth Ribeiro; Silva, Maria Júlia Paes da

2017-01-01

OBJECTIVE To evaluate the effects of instrumental sacred music and sacred music with vocals on the spiritual well-being of bereaved relatives. METHOD This is a randomized clinical trial carried out with family members bereaving the death of loved ones to cancer. Participants were allocated into three groups: Group 1 (control), Group 2 (experimental using sacred music with vocals) or Group 3 (experimental using instrumental sacred music). Spiritual well-being was assessed through the Spiritual Well-Being Scale. RESULTS Sixty-nine (69) family members participated. Mean scores before and after the intervention indicated high levels of spiritual well-being (106.4 and 105.5 in Group 1; 103.2 and 105.2 in Group 2; 107.4 and 108.7 in Group 3) and religious well-being (57.9 and 56.9 in Group 1; 56.3 and 56.4 in Group 2; 57.4 and 58.1 in Group 3), and moderate levels of existential well-being (48.5 and 48.6 in Group 1; 46.9 and 48.9 in Group 2; 49.9 and 50.7 in Group 3), with the exception of Group 3 which presented a high level of existential well-being after the intervention. CONCLUSION The results show that there were no statistically significant differences in the spiritual well-being scores between the experimental groups and the control group. We evidence the need for further studies that use music therapy as a Nursing intervention for bereaved families. Brazilian Registry of Clinical Trials: RBR-2wtwjz.

The effects of name and religious priming on ratings of a well-known political figure, President Barack Obama.

Science.gov (United States)

Williams, Gary A; Guichard, AnaMarie C; An, JungHa

2017-01-01

Priming with race-typed names and religious concepts have been shown to activate stereotypes and increase prejudice towards out-groups. We examined the effects of name and religious word priming on views of a specific and well-known person, President Barack Obama. We predicted that politically conservative participants primed with President Obama's middle name (Hussein) would rate him more negatively and be more likely to view him as a Muslim than those not shown his middle name. We also examined whether conservatives primed with concrete religious words would rate President Obama more negatively and be more likely to view him as Muslim than those primed with other word types. Furthermore, we predicted that those who mis-identify President Obama as Muslim would rate him more negatively than would those who view him as Christian. The results provided mixed support for these hypotheses. Conservatives primed with President Obama's middle name rated him significantly more negatively than did those in the control condition. This effect was not found for politically liberal or moderate participants. Name priming did not significantly affect views of President Obama's religious affiliation. Although not statistically significant, conservatives primed with abstract religious words tended to rate President Obama more negatively than did those primed with other word types. Religious word priming significantly influenced views of President Obama's religious affiliation; interestingly, participants primed with abstract religious words were more likely to think President Obama is Muslim than were those primed with religious agent or non-religious words. As predicted, participants who thought president Obama was Muslim rated him significantly more negatively than did those who thought he was Christian. Overall, our results provide some evidence that ethnic name and religious word priming can significantly influence opinions, even with a well-known and specific person.

The Breathe Easier through Weight Loss Lifestyle (BE WELL Intervention: A randomized controlled trial

Directory of Open Access Journals (Sweden)

Buist A

2010-03-01

Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical

PSYCHOLOGICAL CHARACTERISTICS ANALYSIS: TOP PLAYERS MOTIVATION APPLIED BY WELL-KNOWN COACHES

Directory of Open Access Journals (Sweden)

Naid Kadušić

2011-03-01

Full Text Available Sports psychology, motivation and philosophy are integral part of every team. They make progress in training and contest possible. Psychology helps us to control the mind and body of a player in order to give optimum sporting performance. It is crucial to know how to motivate a player, as well as a team, since a team takes all credits for winning. A special care needs to be taken into account when it comes to preferences, ideas, emotions of players, a team and a coach, of course. There is sports philosphy also, which includes goal setting, behavioural characteristics at the moments of failure, as well as taking into account when, where and at what point to use the philosophy for winning.

The Effect of the More Active MuMs in Stirling Trial on Body Composition and Psychological Well-Being among Postnatal Women

Directory of Open Access Journals (Sweden)

Alyssa S. Lee

2016-01-01

Full Text Available Introduction. Physical activity is important for health and well-being; however, rates of postnatal physical activity can be low. This paper reports the secondary outcomes of a trial aimed at increasing physical activity among postnatal women. Methods. More Active MuMs in Stirling (MAMMiS was a randomised controlled trial testing the effect of physical activity consultation and pram walking group intervention among inactive postnatal women. Data were collected on postnatal weight, body composition, general well-being, and fatigue. Participants were also interviewed regarding motivations and perceived benefits of participating in the trial. Results. There was no significant effect of the intervention on any weight/body composition outcome or on general well-being at three or six months of follow-up. There was a significant but inconsistent difference in fatigue between groups. Qualitative data highlighted a number of perceived benefits to weight, body composition, and particularly well-being (including improved fatigue which were not borne out by objective data. Discussion. The MAMMiS study found no impact of the physical activity intervention on body composition and psychological well-being and indicates that further research is required to identify successful approaches to increase physical activity and improve health and well-being among postnatal women.

The Effect of the More Active MuMs in Stirling Trial on Body Composition and Psychological Well-Being among Postnatal Women.

Science.gov (United States)

Lee, Alyssa S; McInnes, Rhona J; Hughes, Adrienne R; Guthrie, Wendy; Jepson, Ruth

2016-01-01

Introduction. Physical activity is important for health and well-being; however, rates of postnatal physical activity can be low. This paper reports the secondary outcomes of a trial aimed at increasing physical activity among postnatal women. Methods. More Active MuMs in Stirling (MAMMiS) was a randomised controlled trial testing the effect of physical activity consultation and pram walking group intervention among inactive postnatal women. Data were collected on postnatal weight, body composition, general well-being, and fatigue. Participants were also interviewed regarding motivations and perceived benefits of participating in the trial. Results. There was no significant effect of the intervention on any weight/body composition outcome or on general well-being at three or six months of follow-up. There was a significant but inconsistent difference in fatigue between groups. Qualitative data highlighted a number of perceived benefits to weight, body composition, and particularly well-being (including improved fatigue) which were not borne out by objective data. Discussion. The MAMMiS study found no impact of the physical activity intervention on body composition and psychological well-being and indicates that further research is required to identify successful approaches to increase physical activity and improve health and well-being among postnatal women.

Well-known surface and extracellular antigens of pathogenic microorganisms among the immunodominant proteins of the infectious microalgae Prototheca zopfii.

Science.gov (United States)

Irrgang, Alexandra; Murugaiyan, Jayaseelan; Weise, Christoph; Azab, Walid; Roesler, Uwe

2015-01-01

Microalgae of the genus Prototheca (P.) are associated with rare but severe infections (protothecosis) and represent a potential zoonotic risk. Genotype (GT) 2 of P. zopfii has been established as pathogenic agent for humans, dogs, and cattle, whereas GT1 is considered to be non-pathogenic. Since pathogenesis is poorly understood, the aim of this study was to determine immunogenic proteins and potential virulence factors of P. zopfii GT2. Therefore, 2D western blot analyses with sera and isolates of two dogs naturally infected with P. zopfii GT2 have been performed. Cross-reactivity was determined by including the type strains of P. zopfii GT2, P. zopfii GT1, and P. blaschkeae, a close relative of P. zopfii, which is known to cause subclinical forms of bovine mastitis. The sera showed a high strain-, genotype-, and species-cross-reactivity. A total of 198 immunogenic proteins have been analyzed via MALDI-TOF MS. The majority of the 86 identified proteins are intracellularly located (e.g., malate dehydrogenase, oxidoreductase, 3-dehydroquinate synthase) but some antigens and potential virulence factors, known from other pathogens, have been found (e.g., phosphomannomutase, triosephosphate isomerase). One genotype-specific antigen could be identified as heat shock protein 70 (Hsp70), a well-known antigen of eukaryotic pathogens with immunological importance when located extracellularly. Both sera were reactive to glyceraldehyde-3-phosphate-dehydrogenase of all investigated strains. This house-keeping enzyme is found to be located on the surface of several pathogens as virulence factor. Flow-cytometric analysis revealed its presence on the surface of P. blaschkeae.

Staying well after depression: trial design and protocol.

Science.gov (United States)

Williams, J Mark G; Russell, Ian T; Crane, Catherine; Russell, Daphne; Whitaker, Chris J; Duggan, Danielle S; Barnhofer, Thorsten; Fennell, Melanie J V; Crane, Rebecca; Silverton, Sarah

2010-03-19

Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group. This trial compares Mindfulness-Based Cognitive Therapy (MBCT), a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE), an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU). It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter. This will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent depression--that in people who become suicidal when depressed.

Confronting challenges in intervention research with ethnically diverse older adults: the USC Well Elderly II Trial.

Science.gov (United States)

Jackson, Jeanne; Mandel, Deborah; Blanchard, Jeanine; Carlson, Mike; Cherry, Barbara; Azen, Stanley; Chou, Chih-Ping; Jordan-Marsh, Maryalice; Forman, Todd; White, Brett; Granger, Douglas; Knight, Bob; Clark, Florence

2009-02-01

Community-dwelling older adults are at risk for declines in physical health, cognition, and psychosocial well-being. However, their enactment of active and health-promoting lifestyles can reduce such declines. The purpose of this article is to describe the USC Well Elderly II study, a randomized clinical trial designed to test the effectiveness of a healthy lifestyle program for elders, and document how various methodological challenges were addressed during the course of the trial. In the study, 460 ethnically diverse elders recruited from a variety of sites in the urban Los Angeles area were enrolled in a randomized experiment involving a crossover design component. Within either the first or second 6-month phase of their study involvement, each elder received a lifestyle intervention designed to improve a variety of aging outcomes. At 4-5 time points over an 18-24 month interval, the research participants were assessed on measures of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the effectiveness of the intervention and document the process mechanisms responsible for its effects. The study protocol was successfully implemented, including the enrollment of study sites, the recruitment of 460 older adults, administration of the intervention, adherence to the plan for assessment, and establishment of a large computerized data base. Methodological challenges were encountered in the areas of site recruitment, participant recruitment, testing, and intervention delivery. The completion of clinical trials involving elders from numerous local sites requires careful oversight and anticipation of threats to the study design that stem from: (a) social situations that are particular to specific study sites; and (b) physical, functional, and social challenges pertaining to the elder population.

WELLFOCUS PPT - modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial.

Science.gov (United States)

Schrank, Beate; Riches, Simon; Coggins, Tony; Rashid, Tayyab; Tylee, Andre; Slade, Mike

2014-06-03

The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18-65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes

Spiritual therapy to improve the spiritual well-being of Iranian women with breast cancer: a randomized controlled trial.

Science.gov (United States)

Jafari, Najmeh; Farajzadegan, Ziba; Zamani, Ahmadreza; Bahrami, Fatemeh; Emami, Hamid; Loghmani, Amir; Jafari, Nooshin

2013-01-01

Purpose. The aim of this study was to investigate the role of spiritual therapy intervention in improving the spiritual well-being and quality of life (QOL) of Iranian women with breast cancer. Methods. This randomized controlled clinical trial (RCT) recruited 65 women with breast cancer, randomly assigned to a 6-week spirituality-based intervention (n = 34) or control group (n = 31). Before and after six-week spiritual therapy intervention, spiritual well-being and quality of life (QOL) were assessed using Functional Assessment of Chronic Illness Therapy Spiritual Well-being scale (FACIT-Sp12) and cancer quality-of-life questionnaire (QLQ-C30), respectively. t-test, Paired t-test, pearson's correlation, and hierarchical regression analyses were used for analysis using Predictive Analytic software (PASW, version 18) for Windows. Results. After six spiritual therapy sessions, the mean spiritual well-being score from 29.76 (SD = 6.63) to 37.24 (SD = 3.52) in the intervention group (P spiritual well-being and overall QOL. Social functioning was another significant predictor of spiritual well-being. Conclusion. The results of this randomized controlled trial study suggest that participation in spiritual therapy program is associated with improvements in spiritual well-being and QOL. Targeted interventions to acknowledge and incorporate spiritual needs into conventional treatment should be considered in caring of Iranian patients with breast cancer.

Distributed acoustic sensing technique and its field trial in SAGD well

Science.gov (United States)

Han, Li; He, Xiangge; Pan, Yong; Liu, Fei; Yi, Duo; Hu, Chengjun; Zhang, Min; Gu, Lijuan

2017-10-01

Steam assisted gravity drainage (SAGD) is a very promising way for the development of heavy oil, extra heavy oil and tight oil reservoirs. Proper monitoring of the SAGD operations is essential to avoid operational issues and improve efficiency. Among all the monitoring techniques, micro-seismic monitoring and related interpretation method can give useful information about the steam chamber development and has been extensively studied. Distributed acoustic sensor (DAS) based on Rayleigh backscattering is a newly developed technique that can measure acoustic signal at all points along the sensing fiber. In this paper, we demonstrate a DAS system based on dual-pulse heterodyne demodulation technique and did field trial in SAGD well located in Xinjiang Oilfield, China. The field trail results validated the performance of the DAS system and indicated its applicability in steam-chamber monitoring and hydraulic monitoring.

The impact of an employee wellness programme in clothing/textile manufacturing companies: a randomised controlled trial

Directory of Open Access Journals (Sweden)

Edries Naila

2013-01-01

Full Text Available Abstract Background The prevalence of health risk behaviours is growing amongst South African employees. Health risk behaviours have been identified as a major contributor to reduced health related quality of life (HRQoL and the increased prevalence of non-communicable diseases. Worksite wellness programmes promise to promote behaviour changes amongst employees and to improve their HRQoL. The aim of this study was to evaluate the short-term effects of an employee wellness programme on HRQoL, health behaviour change, body mass index (BMI and absenteeism amongst clothing and textile manufacturing employees. Methods The study used a randomised control trial design. The sample consisted of 80 subjects from three clothing manufacturing companies in Cape Town, South Africa. The experimental group was subjected to a wellness programme based on the principles of cognitive behaviour therapy (CBT as well as weekly supervised exercise classes over six weeks. The control group received a once-off health promotion talk and various educational pamphlets, with no further intervention. Measurements were recorded at baseline and at six weeks post-intervention. Outcome measures included the EQ-5D, Stanford Exercise Behaviours Scale, body mass index and absenteeism. Data was analysed with the Statistica-8 software program. Non-parametric tests were used to evaluate the differences in the medians between the two groups and to determine the level of significance. The Sign test was used to determine the within group changes. The Mann–Whitney U test was used to determine the difference between the two groups. Results At six weeks post intervention the experimental group (39 subjects demonstrated improvement in almost every parameter. In contrast, apart from an overall decrease in time off work and a reduction in BMI for all study participants, there was no significant change noted in the behaviour of the control group (41 subjects. Seventy percent of the

Well-known surface and extracellular antigens of pathogenic microorganisms among the immunodominant proteins of the infectious microalgae Prototheca zopfii

Directory of Open Access Journals (Sweden)

Alexandra eIrrgang

2015-09-01

Full Text Available Microalgae of the genus Prototheca (P. are associated with rare but severe infections (protothecosis and represent a potential zoonotic risk. Genotype (GT 2 of P. zopfii has been established as pathogenic agent for humans, dogs and cattle, whereas GT1 is considered to be non-pathogenic. Since pathogenesis is poorly understood, the aim of this study was to determine immunogenic proteins and potential virulence factors of P. zopfii GT2. Therefore, 2D western blot analyses with sera and isolates of two dogs naturally infected with P. zopfii GT2 have been performed. Cross-reactivity was determined by including the type strains of P. zopfii GT2, P. zopfii GT1 and P. blaschkeae, a close relative of P. zopfii, which is known to cause subclinical forms of bovine mastitis. The sera showed a high strain-, genotype-, and species-cross-reactivity. A total of 198 immunogenic proteins have been analysed via MALDI- TOF MS. The majority of the 86 identified proteins are intracellularly located (e.g. malate dehydrogenase, oxidoreductase, 3-dehydroquinate synthase but some antigens and potential virulence factors, known from other pathogens, have been found (e.g. phosphomannomutase, triosephosphate isomerase. One genotype-specific antigen could be identified as heat shock protein 70 (Hsp70, a well-known antigen of eukaryotic pathogens with immunological importance when located extracellularly. Both sera were reactive to glyceraldehyde-3-phosphate-dehydrogenase of all investigated strains. This house-keeping enzyme is found to be located on the surface of several pathogens as virulence factor. Flow-cytometric analysis revealed its presence on the surface of P. blaschkeae.

WELLFOCUS PPT – modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial

Science.gov (United States)

2014-01-01

Background The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. Methods/Design This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18–65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. Discussion This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will

Inherent Risk Factors for Nosocomial Infection in the Long Stay Critically Ill Child Without Known Baseline Immunocompromise: A Post Hoc Analysis of the CRISIS Trial.

Science.gov (United States)

Carcillo, Joseph A; Dean, J Michael; Holubkov, Richard; Berger, John; Meert, Kathleen L; Anand, Kanwaljeet J S; Zimmerman, Jerry; Newth, Christopher J; Harrison, Rick; Burr, Jeri; Willson, Douglas F; Nicholson, Carol; Bell, Michael J; Berg, Robert A; Shanley, Thomas P; Heidemann, Sabrina M; Dalton, Heidi; Jenkins, Tammara L; Doctor, Allan; Webster, Angie

2016-11-01

Nosocomial infection remains an important health problem in long stay (>3 days) pediatric intensive care unit (PICU) patients. Admission risk factors related to the development of nosocomial infection in long stay immune competent patients in particular are not known. Post-hoc analysis of the previously published Critical Illness Stress induced Immune Suppression (CRISIS) prevention trial database, to identify baseline risk factors for nosocomial infection. Because there was no difference between treatment arms of that study in nosocomial infection in the population without known baseline immunocompromise, both arms were combined and the cohort that developed nosocomial infection was compared with the cohort that did not. There were 254 long stay PICU patients without known baseline immunocompromise. Ninety (35%) developed nosocomial infection, and 164 (65%) did not. Admission characteristics associated with increased nosocomial infection risk were increased age, higher Pediatric Risk of Mortality version III score, the diagnoses of trauma or cardiac arrest and lymphopenia (P risk of developing nosocomial infection (P risk factors (P < 0.05); whereas trauma tended to be related to nosocomial infection development (P = 0.07). These data suggest that increasing age, cardiac arrest and lymphopenia predispose long stay PICU patients without known baseline immunocompromise to nosocomial infection. These findings may inform pre-hoc stratification randomization strategies for prospective studies designed to prevent nosocomial infection in this population.

DEFENSE ELEMENTS ANALYSIS IN BASKETBALL APPLIED BY WELL-KNOWN COACHES

Directory of Open Access Journals (Sweden)

Naid Kadušić

2010-09-01

Full Text Available This article describes how to create a man to man defense, how to train it and how to perform a man to man defense from a 2-3 zone defense. Creating a man to man defense is commonly mistaken for oponent press tactics. Coaches tend to devote less attention to defense tactics creation, which can be main weakness in a team. It is important for a team that a coach is aware of the training techniques in order to explain them and present in proper manner. Once player comprehends the training techniques, the period of training comes, which includes helping out at every moment, as well as taking the responsibility. Match outcome and play realization provide a great insight into the players’ game understanding.

Can Early Intervention Improve Maternal Well-Being? Evidence from a Randomized Controlled Trial.

Science.gov (United States)

Doyle, Orla; Delaney, Liam; O'Farrelly, Christine; Fitzpatrick, Nick; Daly, Michael

2017-01-01

This study estimates the effect of a targeted early childhood intervention program on global and experienced measures of maternal well-being utilizing a randomized controlled trial design. The primary aim of the intervention is to improve children's school readiness skills by working directly with parents to improve their knowledge of child development and parenting behavior. One potential externality of the program is well-being benefits for parents given its direct focus on improving parental coping, self-efficacy, and problem solving skills, as well as generating an indirect effect on parental well-being by targeting child developmental problems. Participants from a socio-economically disadvantaged community are randomly assigned during pregnancy to an intensive 5-year home visiting parenting program or a control group. We estimate and compare treatment effects on multiple measures of global and experienced well-being using permutation testing to account for small sample size and a stepdown procedure to account for multiple testing. The intervention has no impact on global well-being as measured by life satisfaction and parenting stress or experienced negative affect using episodic reports derived from the Day Reconstruction Method (DRM). Treatment effects are observed on measures of experienced positive affect derived from the DRM and a measure of mood yesterday. The limited treatment effects suggest that early intervention programs may produce some improvements in experienced positive well-being, but no effects on negative aspects of well-being. Different findings across measures may result as experienced measures of well-being avoid the cognitive biases that impinge upon global assessments.

Can Early Intervention Improve Maternal Well-Being? Evidence from a Randomized Controlled Trial.

Directory of Open Access Journals (Sweden)

Orla Doyle

Full Text Available This study estimates the effect of a targeted early childhood intervention program on global and experienced measures of maternal well-being utilizing a randomized controlled trial design. The primary aim of the intervention is to improve children's school readiness skills by working directly with parents to improve their knowledge of child development and parenting behavior. One potential externality of the program is well-being benefits for parents given its direct focus on improving parental coping, self-efficacy, and problem solving skills, as well as generating an indirect effect on parental well-being by targeting child developmental problems.Participants from a socio-economically disadvantaged community are randomly assigned during pregnancy to an intensive 5-year home visiting parenting program or a control group. We estimate and compare treatment effects on multiple measures of global and experienced well-being using permutation testing to account for small sample size and a stepdown procedure to account for multiple testing.The intervention has no impact on global well-being as measured by life satisfaction and parenting stress or experienced negative affect using episodic reports derived from the Day Reconstruction Method (DRM. Treatment effects are observed on measures of experienced positive affect derived from the DRM and a measure of mood yesterday.The limited treatment effects suggest that early intervention programs may produce some improvements in experienced positive well-being, but no effects on negative aspects of well-being. Different findings across measures may result as experienced measures of well-being avoid the cognitive biases that impinge upon global assessments.

Dopaminergic Modulation of Decision Making and Subjective Well-Being.

Science.gov (United States)

Rutledge, Robb B; Skandali, Nikolina; Dayan, Peter; Dolan, Raymond J

2015-07-08

The neuromodulator dopamine has a well established role in reporting appetitive prediction errors that are widely considered in terms of learning. However, across a wide variety of contexts, both phasic and tonic aspects of dopamine are likely to exert more immediate effects that have been less well characterized. Of particular interest is dopamine's influence on economic risk taking and on subjective well-being, a quantity known to be substantially affected by prediction errors resulting from the outcomes of risky choices. By boosting dopamine levels using levodopa (l-DOPA) as human subjects made economic decisions and repeatedly reported their momentary happiness, we show here an effect on both choices and happiness. Boosting dopamine levels increased the number of risky options chosen in trials involving potential gains but not trials involving potential losses. This effect could be better captured as increased Pavlovian approach in an approach-avoidance decision model than as a change in risk preferences within an established prospect theory model. Boosting dopamine also increased happiness resulting from some rewards. Our findings thus identify specific novel influences of dopamine on decision making and emotion that are distinct from its established role in learning. Copyright © 2015 Rutledge et al.

Dopaminergic Modulation of Decision Making and Subjective Well-Being

Science.gov (United States)

Skandali, Nikolina; Dayan, Peter; Dolan, Raymond J.

2015-01-01

The neuromodulator dopamine has a well established role in reporting appetitive prediction errors that are widely considered in terms of learning. However, across a wide variety of contexts, both phasic and tonic aspects of dopamine are likely to exert more immediate effects that have been less well characterized. Of particular interest is dopamine's influence on economic risk taking and on subjective well-being, a quantity known to be substantially affected by prediction errors resulting from the outcomes of risky choices. By boosting dopamine levels using levodopa (l-DOPA) as human subjects made economic decisions and repeatedly reported their momentary happiness, we show here an effect on both choices and happiness. Boosting dopamine levels increased the number of risky options chosen in trials involving potential gains but not trials involving potential losses. This effect could be better captured as increased Pavlovian approach in an approach–avoidance decision model than as a change in risk preferences within an established prospect theory model. Boosting dopamine also increased happiness resulting from some rewards. Our findings thus identify specific novel influences of dopamine on decision making and emotion that are distinct from its established role in learning. PMID:26156984

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

OpenAIRE

REICHMAN, JEROME H.

2009-01-01

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

Evaluation of antioxidant and radioprotective property of the Jivanti plant, a well-known Rasayana in Ayurveda

International Nuclear Information System (INIS)

Pandey, Sugandha; Hanuma Kumar, Ghali E.N.; Maurya, Dharmendra Kumar

2017-01-01

Jivanti is a well-known Rasayana in Ayurveda and is being used as an ingredient in various formulations like Jivantadya Gharita, Jivatayadi rasa, Jivantayaditaila, Ashwagandhadi Gharita, Anuthaila, Chandanadithaila which are used in various diseases. Jivanti has been claimed to be useful as galactagogue, antibacterial, lactogenic, hypotensive, restorative, tonic and hypoglycaemic activity. In this study we have isolated aqueous crude extract of Jivanti powder and was evaluated for the presence of different phytochemicals using various qualitative and quantitative assays. Further its antioxidant capacity and radioprotective property were evaluated using various in vitro assays. The total antioxidant capacity was estimated by the DPPH, ABTS+ and NO radical scavenging assays. Its reducing power was analyzed by ferric reduction and Molybdenum reduction assays. At the end, radioprotective property was evaluated using plasmid relaxation, lipid peroxidation and propidium iodide staining. Our study shows that the yield of crude aqueous extract from the raw powder was 1.6%. It exhibited concentration dependent DPPH, ABTS+ and NO radical scavenging activity indicating its significant antioxidant capacity. This extract significantly inhibited DNA strand breaks in plasmid pBR322 DNA and peroxidation of membrane lipids against ionizing radiation. Jivanti crude extract decreased radiation induced cell death in splenocytesas monitored by propidium iodide staining. (author)

Spiritual Therapy to Improve the Spiritual Well-Being of Iranian Women with Breast Cancer: A Randomized Controlled Trial

OpenAIRE

Jafari, Najmeh; Farajzadegan, Ziba; Zamani, Ahmadreza; Bahrami, Fatemeh; Emami, Hamid; Loghmani, Amir; Jafari, Nooshin

2013-01-01

Purpose. The aim of this study was to investigate the role of spiritual therapy intervention in improving the spiritual well-being and quality of life (QOL) of Iranian women with breast cancer. Methods. This randomized controlled clinical trial (RCT) recruited 65 women with breast cancer, randomly assigned to a 6-week spirituality-based intervention (n = 34) or control group (n = 31). Before and after six-week spiritual therapy intervention, spiritual well-being and quality of life (QOL) were...

Useful variational principle for the scattering length for the target ground-state wave function imprecisely known

International Nuclear Information System (INIS)

Blau, R.; Rosenberg, L.; Spruch, L.

1977-01-01

A minimum principle for the calculation of the scattering length, applicable when the ground-state wave function of the target system is known precisely, has been available for some time. When, as is almost always the case, the target wave function is imprecisely known, a minimum principle is available but the simple minimum principle noted above is not applicable. Further, as recent calculations show, numerical instabilities usually arise which severely limit the utility of even an ordinary variational approach. The difficulty, which can be traced to the appearance of singularities in the variational construction, is here removed through the introduction of a minimum principle, not for the true scattering length, but for one associated with a closely connected problem. This guarantees that no instability difficulties can arise as the trial scattering wave function and the trial target wave function are improved. The calculations are little different from those required when the target ground-state wave function is known, and, in fact, the original version of the minimum principle is recovered as the trial target wave function becomes exact. A careful discussion is given of the types of problems to which the method can be applied. In particular, the effects of the Pauli principle, and the existence of a finite number of composite bound states, can be accounted for

Wellness-Promoting Practices Through Girl Scouts: A Pragmatic Superiority Randomized Controlled Trial With Additional Dissemination.

Science.gov (United States)

Cull, Brooke J; Dzewaltowski, David A; Guagliano, Justin M; Rosenkranz, Sara K; Knutson, Cassandra K; Rosenkranz, Richard R

2018-01-01

To evaluate the effectiveness of in-person versus online Girl Scout leader wellness training for implementation of wellness-promoting practices during troop meetings (phase I) and to assess training adoption and current practices across the council (phase II). Pragmatic superiority trial (phase 1) followed by serial cross-sectional study (phase II). Girl Scout troop meetings in Northeast Kansas. Eighteen troop leaders from 3 counties (phase 1); 113 troop leaders from 7 counties (phase II). Phase I: Troop leaders attended 2 wellness training sessions (first in groups, second individually), wherein leaders set wellness-promoting practice implementation goals, self-monitored progress, and received guidance and resources for implementation. Leaders received the intervention in person or online. Phase I: At baseline and postintervention, leaders completed a wellness-promoting practice implementation questionnaire assessing practices during troop meetings (max score = 11). Phase II: Leaders completed a survey about typical troop practices and interest in further training. Phase I: Generalized linear mixed modeling. Phase I: In-person training increased wellness-promoting practice implementation more than online training (in person = 2.1 ± 1.8; online = 0.2 ± 1.2; P = .022). Phase II: Fifty-six percent of leaders adopted the training. For 8 of 11 wellness categories, greater than 50% of leaders employed wellness-promoting practices. In-person training was superior to online training for improvements in wellness-promoting practices. Wellness training was adopted by the majority of leaders across the council.

Spiritual Therapy to Improve the Spiritual Well-Being of Iranian Women with Breast Cancer: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Najmeh Jafari

2013-01-01

Full Text Available Purpose. The aim of this study was to investigate the role of spiritual therapy intervention in improving the spiritual well-being and quality of life (QOL of Iranian women with breast cancer. Methods. This randomized controlled clinical trial (RCT recruited 65 women with breast cancer, randomly assigned to a 6-week spirituality-based intervention (n=34 or control group (n=31. Before and after six-week spiritual therapy intervention, spiritual well-being and quality of life (QOL were assessed using Functional Assessment of Chronic Illness Therapy Spiritual Well-being scale (FACIT-Sp12 and cancer quality-of-life questionnaire (QLQ-C30, respectively. t-test, Paired t-test, pearson's correlation, and hierarchical regression analyses were used for analysis using Predictive Analytic software (PASW, version 18 for Windows. Results. After six spiritual therapy sessions, the mean spiritual well-being score from 29.76 (SD=6.63 to 37.24 (SD=3.52 in the intervention group (P<0.001. There was a significant difference between arms of study (F=22.91, P<0.001. A significant positive correlation was detected between meaning and peace with all subscales of functional subscales on European Organization for Research and Treatment of Cancer quality of Life (EORTC QLQ-C30 (P<0.05. Hierarchical regression analyses of participants indicated that the study arm, pain, and financial impact were significant predictors of spiritual well-being and overall QOL. Social functioning was another significant predictor of spiritual well-being. Conclusion. The results of this randomized controlled trial study suggest that participation in spiritual therapy program is associated with improvements in spiritual well-being and QOL. Targeted interventions to acknowledge and incorporate spiritual needs into conventional treatment should be considered in caring of Iranian patients with breast cancer.

Towards understanding the known-key security of block ciphers

DEFF Research Database (Denmark)

Andreeva, Elena; Bogdanov, Andrey; Mennink, Bart

2014-01-01

ciphers based on ideal components such as random permutations and random functions as well as propose new generic known-key attacks on generalized Feistel ciphers. We introduce the notion of known-key indifferentiability to capture the security of such block ciphers under a known key. To show its...... meaningfulness, we prove that the known-key attacks on block ciphers with ideal primitives to date violate security under known-key indifferentiability. On the other hand, to demonstrate its constructiveness, we prove the balanced Feistel cipher with random functions and the multiple Even-Mansour cipher...... with random permutations known-key indifferentiable for a sufficient number of rounds. We note that known-key indifferentiability is more quickly and tightly attained by multiple Even-Mansour which puts it forward as a construction provably secure against known-key attacks....

The LOFAR Known Pulsar Data Pipeline

NARCIS (Netherlands)

Alexov, A.; Hessels, J.W.T.; Mol, J.D.; Stappers, B.; van Leeuwen, J.

2010-01-01

Abstract: Transient radio phenomena and pulsars are one of six LOFAR Key Science Projects (KSPs). As part of the Transients KSP, the Pulsar Working Group (PWG) has been developing the LOFAR Pulsar Data Pipelines to both study known pulsars as well as search for new ones. The pipelines are being

An evaluation of the effectiveness of recruitment methods: the staying well after depression randomized controlled trial.

Science.gov (United States)

Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J Mark G

2014-04-01

Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited, and trials often fail to report sufficient details about the recruitment sources and resources utilized. We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. We describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of (1) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial; (2) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants; and (3) comparison of sociodemographic characteristics of individuals recruited from different sources. Poster advertising, web-based advertising, and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters, and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations, such as those currently unwell, or in

A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus

DEFF Research Database (Denmark)

Jemec, G B E; Ullman, S; Goodfield, M

2009-01-01

BACKGROUND: In a recent open pilot trial, R-salbutamol sulphate, a well-known molecule with anti-inflammatory effects, was tested successfully on patients with therapy-resistant discoid lupus erythematosus (DLE). OBJECTIVES: To compare the efficacy and safety of R-salbutamol cream 0.5% vs. placebo...

The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD.

Science.gov (United States)

Hall, Katherine S; Morey, Miriam C; Beckham, Jean C; Bosworth, Hayden B; Pebole, Michelle M; Pieper, Carl F; Sloane, Richard

2018-03-15

Posttraumatic stress disorder (PTSD) affects up to 30% of military veterans. Older veterans, many of whom have lived with PTSD symptoms for several decades, report a number of negative health outcomes. Despite the demonstrated benefits of regular exercise on physical and psychological health, no studies have explored the impact of exercise in older veterans with PTSD. This paper describes the development, design, and implementation of the Warrior Wellness exercise pilot study for older veterans with PTSD. Veterans aged ≥60 with a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of PTSD will be recruited and randomized to (a) Warrior Wellness, a 12-week supervised, facility-based exercise intervention, or (b) usual care for 12 weeks. Warrior Wellness is a theory- and evidence-based behavioral intervention that involves 3 sessions per week of multi-component exercise training that targets strength, endurance, balance, and flexibility. Warrior Wellness focuses on satisfaction with outcomes, self-efficacy, self-monitoring, and autonomy. Factors associated with program adherence, defined as the number of sessions attended during the 12 weeks, will be explored. Primary outcomes include PTSD symptoms and cardiovascular endurance, assessed at baseline and 12 weeks. Compared to those in usual care, it is hypothesized that those in the Warrior Wellness condition will improve on these efficacy outcomes. The Warrior Wellness study will provide evidence on whether a short-term exercise intervention is feasible, acceptable, and effective among older veterans with PTSD, and explore factors associated with program adherence. ClinicalTrials.gov Identifier : NCT02295995.

A Well-Known but Still Surprising Generator

Science.gov (United States)

Haugland, Ole Anton

2014-01-01

The bicycle generator is often mentioned as an example of a method to produce electric energy. It is cheap and easily accessible, so it is a natural example to use in teaching. There are different types, but I prefer the old side-wall dynamo. The most common explanation of its working principle seems to be something like the illustration in Fig.…

Changes in well-being and quality of life in a randomized trial comparing dynamic psychotherapy and pharmacotherapy for major depressive disorder.

Science.gov (United States)

Zilcha-Mano, Sigal; Dinger, Ulrike; McCarthy, Kevin S; Barrett, Marna S; Barber, Jacques P

2014-01-01

Major depressive disorder (MDD) is associated with a decrease in quality of life (QOL) and well-being. Therefore, researchers are increasingly complementing traditional symptom measurements with QOL and well-being assessments in order to broaden the evaluation of treatment outcomes. The current prospective study investigated the effectiveness of supportive-expressive therapy (SET), antidepressant medication (MED) and placebo (PBO) in improving QOL and well-being in patients with MDD. Data from a randomized controlled trial (trial registration: NCT00043550) comparing SET, MED and PBO for the treatment of depression (N=156) were analyzed. Outcome measures addressed patients' QOL and physical and mental well-being. Changes in outcomes were assessed across and between treatments using linear mixed models. Across treatments, patients showed significant improvement in QOL and mental and physical health measures, as well as a reduction in interpersonal distress and depressive and anxiety symptoms (p≤.002 for all measures). Those changes were not only the products of a decrease in depressive symptoms, but also predicted subsequent reduction in symptoms. No significant differences were found between the three treatment conditions. The limitation is the study's moderate sample size. Current treatments for depression significantly improve patients' QOL and well-being. No significant differences were found between the three conditions examined in this study. The current study highlights the role of well-being in predicting subsequent symptomatic change. © 2013 Published by Elsevier B.V.

Well known and new neutron filters and employment of them for fundamental and applied investigations

International Nuclear Information System (INIS)

Gritzay, O.; Koloty, V.; Libman, V.; Kalchenko, O.; Klimova, N.

2006-01-01

This is a short review of the neutron filtered beam technique developed in Neutron Physics Department (NPD) at Kyiv Research Reactor (KRR) by now. The ways for search of new neutron filters and improving of known ones are described. A short information about characteristics of the existing filters is presented. This review may be useful for users who wish to use the existing filtered beams at KRR or to develop neutron filtered beam technique at their installations

Clinical Trials

Medline Plus

Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

Clinical Trials

Medline Plus

Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... a safety measure. They ensure a trial excludes any people for whom the protocol has known risks ...

Internet trials: participant experiences and perspectives.

Science.gov (United States)

Mathieu, Erin; Barratt, Alexandra; Carter, Stacy M; Jamtvedt, Gro

2012-10-23

Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants' attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants' comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience - a perceived benefit - and a lack connectedness and understanding - a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and confidentiality issues; perceived benefits and

Inference in randomized trials with death and missingness.

Science.gov (United States)

Wang, Chenguang; Scharfstein, Daniel O; Colantuoni, Elizabeth; Girard, Timothy D; Yan, Ying

2017-06-01

In randomized studies involving severely ill patients, functional outcomes are often unobserved due to missed clinic visits, premature withdrawal, or death. It is well known that if these unobserved functional outcomes are not handled properly, biased treatment comparisons can be produced. In this article, we propose a procedure for comparing treatments that is based on a composite endpoint that combines information on both the functional outcome and survival. We further propose a missing data imputation scheme and sensitivity analysis strategy to handle the unobserved functional outcomes not due to death. Illustrations of the proposed method are given by analyzing data from a recent non-small cell lung cancer clinical trial and a recent trial of sedation interruption among mechanically ventilated patients. © 2016, The International Biometric Society.

Frozen desserts and glycemic response in well-controlled NIDDM patients.

Science.gov (United States)

Bukar, J; Mezitis, N H; Saitas, V; Pi-Sunyer, F X

1990-04-01

Fructose is known to elicit a lower glycemic response than sucrose, and high-fructose desserts have been recommended for a diabetic diet. We compared a cholesterol-free tofu-based frozen dessert (TFD) containing high-fructose corn syrups with a dairy-based sucrose-sweetened ice cream (IC). Six male and six female non-insulin-dependent diabetic patients (mean age 51 yr, mean ideal body weight 143%, fasting blood glucose less than 160 mg/dl) with well-controlled diabetes and managed on oral hypoglycemic agents were studied. Subjects underwent three trials. In the first trial they ingested 50 g glucose, and in the next two trials they ingested 50-g carbohydrate equivalents of either TFD or IC in random sequence. Venous blood was drawn at intervals during the 3-h trials for glucose and insulin determinations. Fasting plasma glucose was not statistically different between IC and TFD trials (130 vs. 121 mg/dl). Peak glucose responses were at 120 min in both trials (190 mg/dl for IC and 222 mg/dl for TFD), with those for TFD being significantly higher (P less than 0.01). Mean glucose area and glycemic index for TFD were significantly greater than for IC (P less than 0.01 and P less than 0.03, respectively). There was no significant difference between mean insulin areas. In summary, the TFD, which contains soybean curd and high-fructose corn syrup, might have been expected to produce more satisfactory postprandial blood glucose levels than IC, which contains sucrose, yet a higher glycemic response was elicited. This is related to the substantial amount of total glucose in this "fructose" dessert.(ABSTRACT TRUNCATED AT 250 WORDS)

Low-cost glass ionomer cement as ART sealant in permanent molars: a randomized clinical trial

NARCIS (Netherlands)

Hesse, D.; Bonifácio, C.C.; Guglielmi, C. de Almeida Brandao; da Franca, C.; Mendes, F.M.; Raggio, D.P.

2015-01-01

Clinical trials are normally performed with well-known brands of glass ionomer cement (GIC), but the cost of these materials is high for public healthcare in less-affluent communities. Given the need to research cheaper materials, it seems pertinent to investigate the retention rate of a low-cost

Happy@Work: protocol for a web-based randomized controlled trial to improve mental well-being among an Asian working population.

Science.gov (United States)

Yuan, Qi; Liu, Su; Tang, Szehang; Zhang, Dexing

2014-07-04

Mental health issues pose a serious concern in the workplace for the huge productivity loss and financial burden associated with it. Unlike the traditional 'fixing-what-is-wrong' approach, positive psychology offers a less-stigmatized way to promote mental health. Psychological capital, a concept originated from positive psychology, has been proven effective in improving mental well-being and work performance. However, little evidence exists for its implementation among Asian working population or its cost-benefit for organizations adopting such promotion strategy. The current study is designed to assess the protective effects of a web-based psychology capital intervention among Hong Kong working population on individuals' mental health and work performance, as well as organizations' return-on-investment. A two-arm randomized controlled trial design will be adopted. Eligible working adults will be randomly allocated to either the intervention group or the waiting-list control group, with 177 participants in each arm. The intervention, which consists of four web-based training sessions, each targeting one of the psychological capital components (hope, efficacy, optimism and resilience), will be implemented over a 4-week period. On-line surveys will assess the participants in each group at baseline, intervention completion, 1 and 3 months after the completion. The primary outcome is individuals' psychological capital level; secondary outcomes include individuals' well-being, depressive symptoms, work engagement and productivity. Return-on-investment will be calculated from the employers' perspective based on productivity gain, savings in medical expenditure, as well as operation and time costs. Analysis will follow the intention-to-treat principle. This is the first experimental study that explores the applicability of psychological capital development among Asian population. Through investigating changes in individuals' work productivity from absenteeism and

Clinical Trials

Medline Plus

Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

Effect of spiritual counseling on spiritual well-being in Iranian women with cancer: A randomized clinical trial.

Science.gov (United States)

Sajadi, Mahbobeh; Niazi, Naimeh; Khosravi, Sharareh; Yaghobi, Abolghasem; Rezaei, Mahboubeh; Koenig, Harold G

2018-02-01

This study examined the effect of spiritual counseling on the spiritual well-being of Iranian women with cancer. a randomized clinical trial was conducted on 42 female cancer patients who were randomized to either an 8-week spiritual counseling intervention (n = 21) or a control group that received routine education/care (n = 21). Spiritual well-being (SWB) was assessed before and after the 8-week spiritual counseling program using Paloutzian and Ellison's (1983) Spiritual Well-Being Scale (SWBS). There were no significant differences on SWBS and its two subscales scores (RWB and EWB) between intervention and control groups at baseline (p > .05). After intervention, there was a significant mean difference in SWB (p = .001), RWB (p = .013) and EWB (p = .001) in two groups. Spiritual counseling is associated with significant improvements in SWB in Iranian women with cancer. Interventions that acknowledge the spiritual needs of these patients should be incorporated into conventional treatments. Copyright © 2017. Published by Elsevier Ltd.

Coronary heart disease risk in patients with stroke or transient ischemic attack and no known coronary heart disease: findings from the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

DEFF Research Database (Denmark)

Amarenco, Pierre; Goldstein, Larry B; Sillesen, Henrik

2010-01-01

Noncoronary forms of atherosclerosis (including transient ischemic attacks or stroke of carotid origin or >50% stenosis of the carotid artery) are associated with a 10-year vascular risk of >20% and are considered as a coronary heart disease (CHD) -risk equivalent from the standpoint of lipid...... management. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial included patients with stroke or transient ischemic attack and no known CHD regardless of the presence of carotid atherosclerosis. We evaluated the risk of developing clinically recognized CHD in SPARCL patients....

Plasma Outflows: Known Knowns, Known Unknowns, and The Unknown

Science.gov (United States)

Moore, T. E.

2012-01-01

A brief summary is given of i) what we know from observing ionospheric outflows and ii) how outflow parameterizations are being used in global simulations to evaluate their effects on magnetospheric dynamics. Then, a list of unanswered questions and issues to be resolved is given, followed by a description of the known future mission plans expressed in the Heliophysics Roadmap, such as Origin of Near-Earth Plasmas (ONEP), and Ion-Neutral Coupling in the Atmosphere (INCA). Finally, a set of requirements for definitive plasma outflow observations are identified, along with possible methods for fulfilling them in future missions. Since results of the current Heliophysics Decadal Survey are expected soon, it is hoped that future plans can be summarized and discussed without speculation at the GEM 2012 meeting.

Internet trials: participant experiences and perspectives

Science.gov (United States)

2012-01-01

Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and

Internet trials: participant experiences and perspectives

Directory of Open Access Journals (Sweden)

Mathieu Erin

2012-10-01

Full Text Available Abstract Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate. Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet

From lesser-known to super vegetables: the growing profile of African traditional leafy vegetables in promoting food security and wellness.

Science.gov (United States)

Aworh, Ogugua C

2018-08-01

There are hundreds of traditional leafy vegetables and wild food plants of horticultural and nutritional significance in Africa. These lesser-known crops and wild food plants that are highly adapted to harsh growing conditions thrive with little care and are available when other sources of food fail or are out of season. They are rich in micronutrients and are often the cheapest sources of many essential vitamins and minerals in many localities. Many of them are very important functional foods in African traditional diets and are rich in nutraceuticals, including polyphenols, tannins, flavonoids and flavonols, that exert demonstrable antioxidant, free radical scavenging and enzyme inhibition activities and have antimicrobial properties that provide scientific justification and possible mechanisms for their use in the management of a wide range of ailments, including diet-related, non-communicable diseases such as diabetes, hypertension and cardiovascular diseases. African traditional leafy vegetables are invaluable in promoting food security and wellness in Africa on account of their availability and affordability, their great nutritional value, chemotherapeutic and health-promoting properties and other unique qualities. Long recognised by the rural populace as quality food items, they are becoming more popular even with the more affluent urban elites. There is the need to develop improved management practices for these super vegetables to promote their cultivation and boost their exploitation for food security and wellness in Africa. © 2018 Society of Chemical Industry. © 2018 Society of Chemical Industry.

Clinical Trials

Medline Plus

Full Text Available ... Some companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients. Protocol Version 9, 19 February 2007 known as SIGNET (Scottish Intensive care Glutamine or seleNium Evaluative Trial

Directory of Open Access Journals (Sweden)

Vale Luke D

2007-09-01

Full Text Available Abstract Background Mortality rates in the Intensive Care Unit and subsequent hospital mortality rates in the UK remain high. Infections in Intensive Care are associated with a 2–3 times increased risk of death. It is thought that under conditions of severe metabolic stress glutamine becomes "conditionally essential". Selenium is an essential trace element that has antioxidant and anti-inflammatory properties. Approximately 23% of patients in Intensive Care require parenteral nutrition and glutamine and selenium are either absent or present in low amounts. Both glutamine and selenium have the potential to influence the immune system through independent biochemical pathways. Systematic reviews suggest that supplementing parenteral nutrition in critical illness with glutamine or selenium may reduce infections and mortality. Pilot data has shown that more than 50% of participants developed infections, typically resistant organisms. We are powered to show definitively whether supplementation of PN with either glutamine or selenium is effective at reducing new infections in critically ill patients. Methods/design 2 × 2 factorial, pragmatic, multicentre, double-blind, randomised controlled trial. The trial has an enrolment target of 500 patients. Inclusion criteria include: expected to be in critical care for at least 48 hours, aged 16 years or over, patients who require parenteral nutrition and are expected to have at least half their daily nutritional requirements given by that route. Allocation is to one of four iso-caloric, iso-nitrogenous groups: glutamine, selenium, both glutamine & selenium or no additional glutamine or selenium. Trial supplementation is given for up to seven days on the Intensive Care Unit and subsequent wards if practicable. The primary outcomes are episodes of infection in the 14 days after starting trial nutrition and mortality. Secondary outcomes include antibiotic usage, length of hospital stay, quality of life and

Efficacy versus effectiveness trials : informing guidelines for asthma management

NARCIS (Netherlands)

Price, David; Hillyer, Elizabeth V.; van der Molen, Thys

Purpose of review Randomized controlled trials, known as efficacy trials and long considered the gold standard for evidence-based asthma guidelines, are designed to test whether interventions have a benefit for selective patient populations under ideal conditions. The goal of pragmatic trials and

Do textbooks address known learning challenges in area measurement? A comparative analysis

Science.gov (United States)

Hong, Dae S.; Choi, Kyong Mi; Runnalls, Cristina; Hwang, Jihyun

2018-02-01

This study compared area lessons from Korean textbooks and US standard-based textbooks to understand differences and similarities among these textbooks, as well as how these textbooks address known learning challenges in area measurement. Several well-known challenges have been identified in previous studies, such as covering, array structure, and linking array structure to area formula. We were interested in knowing if textbooks addressed these issues in their treatments of area measurement and, in doing so, provided students with opportunities to overcome or become familiar with known challenges. The results show that both countries' textbooks demonstrated similar limitations; only few area and area-related lessons are covered and three important learning challenges in area measurement are not covered well, which need to be informed to practicing teachers.

Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients. Protocol Version 9, 19 February 2007 known as SIGNET (Scottish Intensive care Glutamine or seleNium Evaluative Trial).

Science.gov (United States)

Andrews, Peter J D; Avenell, Alison; Noble, David W; Campbell, Marion K; Battison, Claire G; Croal, Bernard L; Simpson, William G; Norrie, John; Vale, Luke D; Cook, Jonathon; de Verteuil, Robyn; Milne, Anne C

2007-09-20

Mortality rates in the Intensive Care Unit and subsequent hospital mortality rates in the UK remain high. Infections in Intensive Care are associated with a 2-3 times increased risk of death. It is thought that under conditions of severe metabolic stress glutamine becomes "conditionally essential". Selenium is an essential trace element that has antioxidant and anti-inflammatory properties. Approximately 23% of patients in Intensive Care require parenteral nutrition and glutamine and selenium are either absent or present in low amounts. Both glutamine and selenium have the potential to influence the immune system through independent biochemical pathways. Systematic reviews suggest that supplementing parenteral nutrition in critical illness with glutamine or selenium may reduce infections and mortality. Pilot data has shown that more than 50% of participants developed infections, typically resistant organisms. We are powered to show definitively whether supplementation of PN with either glutamine or selenium is effective at reducing new infections in critically ill patients. 2 x 2 factorial, pragmatic, multicentre, double-blind, randomised controlled trial. The trial has an enrollment target of 500 patients. Inclusion criteria include: expected to be in critical care for at least 48 hours, aged 16 years or over, patients who require parenteral nutrition and are expected to have at least half their daily nutritional requirements given by that route. Allocation is to one of four iso-caloric, iso-nitrogenous groups: glutamine, selenium, both glutamine & selenium or no additional glutamine or selenium. Trial supplementation is given for up to seven days on the Intensive Care Unit and subsequent wards if practicable. The primary outcomes are episodes of infection in the 14 days after starting trial nutrition and mortality. Secondary outcomes include antibiotic usage, length of hospital stay, quality of life and cost-effectiveness. To date more than 285 patients have been

Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

DEFF Research Database (Denmark)

Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

2016-01-01

BACKGROUND: Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe......Med and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about...

Nearby, Well Known. The Parochial Realm of Neighborhoods

Directory of Open Access Journals (Sweden)

Margarethe Kusenbach

2011-03-01

urba neighborhoods often fail to notice that their research areas are typically slices of the parochial realm, meaning a social territory that is not unique to cities but also common in suburbs and even small towns. Of course, there can be huge differences between an urban hood and a small town quarter yet both share important characteristics which some urban scholars overlook in their belief that city boundaries, density and diversity, or a certain look and feel guarantee the urban-ness of their research areas.

Accretion onto some well-known regular black holes

International Nuclear Information System (INIS)

Jawad, Abdul; Shahzad, M.U.

2016-01-01

In this work, we discuss the accretion onto static spherically symmetric regular black holes for specific choices of the equation of state parameter. The underlying regular black holes are charged regular black holes using the Fermi-Dirac distribution, logistic distribution, nonlinear electrodynamics, respectively, and Kehagias-Sftesos asymptotically flat regular black holes. We obtain the critical radius, critical speed, and squared sound speed during the accretion process near the regular black holes. We also study the behavior of radial velocity, energy density, and the rate of change of the mass for each of the regular black holes. (orig.)

Accretion onto some well-known regular black holes

Energy Technology Data Exchange (ETDEWEB)

Jawad, Abdul; Shahzad, M.U. [COMSATS Institute of Information Technology, Department of Mathematics, Lahore (Pakistan)

2016-03-15

In this work, we discuss the accretion onto static spherically symmetric regular black holes for specific choices of the equation of state parameter. The underlying regular black holes are charged regular black holes using the Fermi-Dirac distribution, logistic distribution, nonlinear electrodynamics, respectively, and Kehagias-Sftesos asymptotically flat regular black holes. We obtain the critical radius, critical speed, and squared sound speed during the accretion process near the regular black holes. We also study the behavior of radial velocity, energy density, and the rate of change of the mass for each of the regular black holes. (orig.)

Accretion onto some well-known regular black holes

Science.gov (United States)

Jawad, Abdul; Shahzad, M. Umair

2016-03-01

In this work, we discuss the accretion onto static spherically symmetric regular black holes for specific choices of the equation of state parameter. The underlying regular black holes are charged regular black holes using the Fermi-Dirac distribution, logistic distribution, nonlinear electrodynamics, respectively, and Kehagias-Sftesos asymptotically flat regular black holes. We obtain the critical radius, critical speed, and squared sound speed during the accretion process near the regular black holes. We also study the behavior of radial velocity, energy density, and the rate of change of the mass for each of the regular black holes.

The psychological aspects of a well-known issue

Science.gov (United States)

Arka, Ioanna

2018-01-01

From the PhD through several post-doctoral positions, to the few permanent academic posts, the selection processes determining who will populate the upper echelons of academic astronomy might not involve just merit, hard work or dedication.

Log-concavity property for some well-known distributions

Directory of Open Access Journals (Sweden)

G. R. Mohtashami Borzadaran

2011-12-01

Full Text Available Interesting properties and propositions, in many branches of science such as economics have been obtained according to the property of cumulative distribution function of a random variable as a concave function. Caplin and Nalebuff (1988,1989, Bagnoli and Khanna (1989 and Bagnoli and Bergstrom (1989 , 1989, 2005 have discussed the log-concavity property of probability distributions and their applications, especially in economics. Log-concavity concerns twice differentiable real-valued function g whose domain is an interval on extended real line. g as a function is said to be log-concave on the interval (a,b if the function ln(g is a concave function on (a,b. Log-concavity of g on (a,b is equivalent to g'/g being monotone decreasing on (a,b or (ln(g" 6] have obtained log-concavity for distributions such as normal, logistic, extreme-value, exponential, Laplace, Weibull, power function, uniform, gamma, beta, Pareto, log-normal, Student's t, Cauchy and F distributions. We have discussed and introduced the continuous versions of the Pearson family, also found the log-concavity for this family in general cases, and then obtained the log-concavity property for each distribution that is a member of Pearson family. For the Burr family these cases have been calculated, even for each distribution that belongs to Burr family. Also, log-concavity results for distributions such as generalized gamma distributions, Feller-Pareto distributions, generalized Inverse Gaussian distributions and generalized Log-normal distributions have been obtained.

Optimization and limitations of known DEMO divertor concepts

Energy Technology Data Exchange (ETDEWEB)

Reiser, Jens, E-mail: Jens.Reiser@kit.edu [Karlsruhe Institute of Technology, Institute for Applied Materials, P.O. Box 3640, 76021 Karlsruhe (Germany); Rieth, Michael [Karlsruhe Institute of Technology, Institute for Applied Materials, P.O. Box 3640, 76021 Karlsruhe (Germany)

2012-08-15

Highlights: Black-Right-Pointing-Pointer Limitations of the materials. Black-Right-Pointing-Pointer Improved H{sub 2}O cooled divertor. Black-Right-Pointing-Pointer Improved He cooled divertor. - Abstract: In this work we will introduce and discuss improvements for two types of DEMO divertors based on known designs: (i) gas cooled designs and (ii) liquid coolant concepts. In a first step, the advantages and disadvantages of gas cooling as well as the necessity of a jet impingement to increase the heat transfer coefficients will be discussed. Further discussion deals with the pros and cons of liquid coolant concepts, like for example, liquid metal or water cooling. Thereafter, we will present two rather contrary DEMO divertor concepts which are based on today's knowledge on refractory materials science, fabrication and joining technology. The first improved concept uses water flowing through steel pipes, typically made of Eurofer steel. It is well known that using Eurofer at low temperatures is critical due to its severe embrittlement under neutron irradiation. Here we make a proposal how it could be possible to use the Eurofer steel anyway: the solution could consist in a limited operation period followed by an annealing cycle at 550 Degree-Sign C for a few hours during any maintenance shut down phases. The second design is based on the known helium cooling concept using jet impingement. Drawbacks of the actual He-cooled divertor design are small scale parts as well as the necessary high helium inlet temperature of about 600-800 Degree-Sign C which leads to the question: How can we deal with such high helium temperatures? This paper shows a solution for large scale components as well as a new thermal management for the helium outlet gas that we call 'cooling of the coolant'. Both concepts are discussed in terms of materials selection due to material limits and joining technology with a special focus on the material issue using already existing and

Optimization and limitations of known DEMO divertor concepts

International Nuclear Information System (INIS)

Reiser, Jens; Rieth, Michael

2012-01-01

Highlights: ► Limitations of the materials. ► Improved H 2 O cooled divertor. ► Improved He cooled divertor. - Abstract: In this work we will introduce and discuss improvements for two types of DEMO divertors based on known designs: (i) gas cooled designs and (ii) liquid coolant concepts. In a first step, the advantages and disadvantages of gas cooling as well as the necessity of a jet impingement to increase the heat transfer coefficients will be discussed. Further discussion deals with the pros and cons of liquid coolant concepts, like for example, liquid metal or water cooling. Thereafter, we will present two rather contrary DEMO divertor concepts which are based on today's knowledge on refractory materials science, fabrication and joining technology. The first improved concept uses water flowing through steel pipes, typically made of Eurofer steel. It is well known that using Eurofer at low temperatures is critical due to its severe embrittlement under neutron irradiation. Here we make a proposal how it could be possible to use the Eurofer steel anyway: the solution could consist in a limited operation period followed by an annealing cycle at 550 °C for a few hours during any maintenance shut down phases. The second design is based on the known helium cooling concept using jet impingement. Drawbacks of the actual He-cooled divertor design are small scale parts as well as the necessary high helium inlet temperature of about 600–800 °C which leads to the question: How can we deal with such high helium temperatures? This paper shows a solution for large scale components as well as a new thermal management for the helium outlet gas that we call ‘cooling of the coolant’. Both concepts are discussed in terms of materials selection due to material limits and joining technology with a special focus on the material issue using already existing and available materials.

Clinical Trials

Medline Plus

Full Text Available ... products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ... cancer also increased. As a result, the U.S. Food and Drug Administration now recommends never using HT ... Clinical Trials Work If you take ...

Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial.

Science.gov (United States)

Mimila, Naomi A; Chung, Paul J; Elliott, Marc N; Bethell, Christina D; Chacon, Sandra; Biely, Christopher; Contreras, Sandra; Chavis, Toni; Bruno, Yovana; Moss, Tanesha; Coker, Tumaini R

Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT), is a well-child care (WCC) model that has demonstrated effectiveness in improving the receipt of comprehensive WCC services and reducing emergency department utilization for children aged 0 to 3 in low-income communities. PARENT relies on a health educator ("parent coach") to provide WCC services; it utilizes a Web-based previsit prioritization/screening tool (Well-Visit Planner) and an automated text message reminder/education service. We sought to assess intervention feasibility and acceptability among PARENT trial intervention participants. Intervention parents completed a survey after a 12-month study period; a 26% random sample of them were invited to participate in a qualitative interview. Interviews were recorded, transcribed, and analyzed using the constant comparative method of qualitative analysis; survey responses were analyzed using bivariate methods. A total of 115 intervention participants completed the 12-month survey; 30 completed a qualitative interview. Nearly all intervention participants reported meeting with the coach, found her helpful, and would recommend continuing coach-led well visits (97-99%). Parents built trusting relationships with the coach and viewed her as a distinct and important part of their WCC team. They reported that PARENT well visits more efficiently used in-clinic time and were comprehensive and family centered. Most used the Well-Visit Planner (87%), and found it easy to use (94%); a minority completed it at home before the visit (18%). Sixty-two percent reported using the text message service; most reported it as a helpful source of new information and a reinforcement of information discussed during visits. A parent coach-led intervention for WCC for young children is a model of WCC delivery that is both acceptable and feasible to parents in a low-income urban population. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All

Clinical Trials

Medline Plus

Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...

Analysis gives alterations stable chromosomic induced by the radiation in vitro the sanguine samples to well-known dose. Preliminary results obtained by means of chromosomic painting

International Nuclear Information System (INIS)

Prieto, M.J.; Moreno, M.; Gomez-Espi, M.; Olivares, P.; Herranz, R.

1998-01-01

In the University General Hospital Gregorio Marannon, once standardized the technique in situ hybridization with fluorescence by means of painting chromosomic the couples 1 and 2 you this carrying out the irradiation gives sanguine samples to well-known dose The objective these irradiations it is the elaboration in vitro a calibration chart dose effect for gamma ray. This new curve will allow to estimate dose in individuals with suspicion overexposure to ionizing radiations, solving some gives the limitations that it presents the technique classic cytogenetics

Phase I trial of neoadjuvant concurrent chemoradiotherapy with S-1 and weekly irinotecan in locally advanced rectal cancer

International Nuclear Information System (INIS)

Choi, Hye Jin; Kim, Nam-Kyu; Keum, Ki Chang; Cheon, Seong Ha; Shin, Sang Jun; Baik, Seung Hyuk; Choen, Jae Hee; Rha, Sun Young; Roh, Jae Kyung; Jeung, Hei-Cheul; Chung, Hyun Cheol; Ahn, Joong Bae

2008-01-01

S-1 is a novel, oral fluoropyrimidine and a known radiosensitizer. We conducted a phase I trial to establish a schedule of S-1/irinotecan with standard pelvic radiotherapy as a preoperative treatment of locally advanced rectal cancer. Our findings suggest that this new combination is feasible and well tolerable

Probing the Gaps: A Synthesis of Well-known and Lesser-known Hydrological Feedbacks Influencing Vegetation Patterning and Long-term Geomorphic Change in Low-gradient Fluvial Landscapes

Science.gov (United States)

Larsen, L.; Christensen, A.; Harvey, J. W.; Ma, H.; Newman, S.; Saunders, C.; Twilley, R.

2017-12-01

Emergence of vegetation patterning in fluvial landscapes is a classic example of how autogenic processes can drive long term fluvial and geomorphic adjustments in aquatic ecosystems. Studies elucidating the physics of flow through vegetation patches have produced understanding of how patterning in topography and vegetation commonly emerges and what effect it has on long term geomorphic change. However, with regard to mechanisms underlying pattern existence and resilience, several knowledge gaps remain, including the role of landscape-scale flow-vegetation feedbacks, feedbacks that invoke additional biogeochemical or biological agents, and determination of the relative importance of autogenic processes relative to external drivers. Here we provide a synthesis of the processes over a range of scales known to drive vegetation patterning and sedimentation in low gradient fluvial landscapes, emphasizing recent field and modeling studies in the Everglades, FL and Wax Lake Delta, LA that address these gaps. In the Everglades, while flow routing and sediment redistribution at the patch scale is known to be a primary driver of vegetation pattern emergence, landscape-scale routing of flow, as driven by the landscape's connectivity, can set up positive feedbacks that influence the rate of pattern degradation. Recent flow release experiments reveal that an additional feedback, involving phosphorus concentrations, flow, and floating vegetation communities that are abundant under low phosphorus, low flow conditions further stabilizes the alternative landscape states established through local scale sediment redistribution. Biogeochemistry-vegetation-sediment feedbacks may also be important for geomorphic development of newly emerging landscapes such as the Wax Lake Delta. There, fine sediment deposition shapes hydrogeomorphic zones with vegetation patterns that stimulate the growth of biofilm, while biofilm characteristics override the physical characteristics of vegetation

Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

DEFF Research Database (Denmark)

Gluud, Christian; Nikolova, Dimitrinka

2007-01-01

The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....

Jerome Lewis Duggan: A Nuclear Physicist and a Well-Known, Six-Decade Accelerator Application Conference (CAARI) Organizer

Science.gov (United States)

Del McDaniel, Floyd; Doyle, Barney L.

Jerry Duggan was an experimental MeV-accelerator-based nuclear and atomic physicist who, over the past few decades, played a key role in the important transition of this field from basic to applied physics. His fascination for and application of particle accelerators spanned almost 60 years, and led to important discoveries in the following fields: accelerator-based analysis (accelerator mass spectrometry, ion beam techniques, nuclear-based analysis, nuclear microprobes, neutron techniques); accelerator facilities, stewardship, and technology development; accelerator applications (industrial, medical, security and defense, and teaching with accelerators); applied research with accelerators (advanced synthesis and modification, radiation effects, nanosciences and technology); physics research (atomic and molecular physics, and nuclear physics); and many other areas and applications. Here we describe Jerry’s physics education at the University of North Texas (B. S. and M. S.) and Louisiana State University (Ph.D.). We also discuss his research at UNT, LSU, and Oak Ridge National Laboratory, his involvement with the industrial aspects of accelerators, and his impact on many graduate students, colleagues at UNT and other universities, national laboratories, and industry and acquaintances around the world. Along the way, we found it hard not to also talk about his love of family, sports, fishing, and other recreational activities. While these were significant accomplishments in his life, Jerry will be most remembered for his insight in starting and his industry in maintaining and growing what became one of the most diverse accelerator conferences in the world — the International Conference on the Application of Accelerators in Research and Industry, or what we all know as CAARI. Through this conference, which he ran almost single-handed for decades, Jerry came to know, and became well known by, literally thousands of atomic and nuclear physicists, accelerator

The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Inoue, Takuya; Takagi, Hironori; Owada, Yuki; Watanabe, Yuzuru; Yamaura, Takumi; Fukuhara, Mitsuro; Muto, Satoshi; Okabe, Naoyuki; Matsumura, Yuki; Hasegawa, Takeo; Osugi, Jun; Hoshino, Mika; Higuchi, Mitsunori; Shio, Yutaka; Yokouchi, Hiroshi; Kanazawa, Kenya; Ohbuchi, Katsuya; Fukushima, Takahisa; Munakata, Mitsuru; Suzuki, Hiroyuki

2017-10-18

Cisplatin is a key drug in lung cancer therapy. However, cisplatin is also well known to induce gastrointestinal disorders, such as chemotherapy-induced nausea and vomiting, anorexia, and weight loss. These symptoms sometimes affect patients' quality of life and make continuation of chemotherapy difficult. Anorexia is a cause of concern for patients with cancer because a persistent loss of appetite progresses to cancer cachexia. Although evidence-based management for chemotherapy has recently been established, there is room for improvement. This placebo-controlled, double-blind, randomized trial will aim to determine the efficacy of the traditional Japanese Kampo medicine rikkunshito (TJ-43) for preventing anorexia caused by cisplatin-including chemotherapy in patients with lung cancer. Patients with lung cancer who plan to receive cisplatin-including chemotherapy will be recruited. Patients who provide written consent will be randomly allocated to receive either TJ-43 (arm A) or placebo (arm B) for one course of chemotherapy (21 or 28 consecutive days). Investigators and patients will be masked to the treatment assignment throughout the trial. The primary endpoint will be evaluated as the change in dietary intake from day 0 (the day before the start of chemotherapy) to day 7 of cisplatin-including chemotherapy. The two arms of the trial will comprise 30 patients each. From November 2014, a total of 60 patients will be recruited, and recruitment for the study is planned to be complete by October 2017. This trial is designed to examine the efficacy of rikkunshito (TJ-43) for reducing anorexia and maintaining food intake caused by cisplatin-including chemotherapy in patients with lung cancer. Japan Pharmaceutical Information Center Clinical Trials Information (JAPIC CTI), trial registration: JAPIC CTI-142747 . Registered on 15 December 2014; the RICH trial.

Using a business model approach and marketing techniques for recruitment to clinical trials

Directory of Open Access Journals (Sweden)

Knight Rosemary

2011-03-01

Full Text Available Abstract Randomised controlled trials (RCTs are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies. Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques. We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies.

Using a business model approach and marketing techniques for recruitment to clinical trials

Science.gov (United States)

2011-01-01

Randomised controlled trials (RCTs) are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies. Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques. We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies. PMID:21396088

Using a business model approach and marketing techniques for recruitment to clinical trials.

Science.gov (United States)

McDonald, Alison M; Treweek, Shaun; Shakur, Haleema; Free, Caroline; Knight, Rosemary; Speed, Chris; Campbell, Marion K

2011-03-11

Randomised controlled trials (RCTs) are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies.Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques.We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies.

Clinical Trials

Medline Plus

Full Text Available ... small groups of people for safety and side effects. Phase II clinical trials look at how well ... confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ...

Gender-Based Differences in Surgical Residents' Perceptions of Patient Safety, Continuity of Care, and Well-Being: An Analysis from the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial.

Science.gov (United States)

Ban, Kristen A; Chung, Jeanette W; Matulewicz, Richard S; Kelz, Rachel R; Shea, Judy A; Dahlke, Allison R; Quinn, Christopher M; Yang, Anthony D; Bilimoria, Karl Y

2017-02-01

Little is known about gender differences in residency training experiences and whether duty hour policies affect these differences. Using data from the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial, we examined gender differences in surgical resident perceptions of patient safety, education, health and well-being, and job satisfaction, and assessed whether duty hour policies affected gender differences. We compared proportions of male and female residents expressing dissatisfaction or perceiving a negative effect of duty hours on aspects of residency training (ie patient safety, resident education, well-being, job satisfaction) overall and by PGY. Logistic regression models with robust clustered SEs were used to test for significant gender differences and interaction effects of duty hour policies on gender differences. Female PGY2 to 3 residents were more likely than males to be dissatisfied with patient safety (odds ratio [OR] = 2.50; 95% CI, 1.29-4.84) and to perceive a negative effect of duty hours on most health and well-being outcomes (OR = 1.51-2.10; all p duty hours reduced gender differences in career dissatisfaction among interns (p = 0.028), but widened gender differences in negative perceptions of duty hours on patient safety (p duty hour policies. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Effects of a standard provision versus an autonomy supportive exercise referral programme on physical activity, quality of life and well-being indicators: a cluster randomised controlled trial

Science.gov (United States)

2014-01-01

Background The National Institute for Health and Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the feasibility and impact of a Self Determination Theory-based (SDT) exercise referral consultation. Methods An exploratory cluster randomised controlled trial comparing standard provision exercise referral with an exercise referral intervention grounded in Self Determination Theory. Individuals (N = 347) referred to an exercise referral scheme were recruited into the trial from 13 centres. Outcomes and processes of change measured at baseline, 3 and 6-months: Minutes of self-reported moderate or vigorous physical activity (PA) per week (primary outcome), health status, positive and negative indicators of emotional well-being, anxiety, depression, quality of life (QOL), vitality, and perceptions of autonomy support from the advisor, need satisfaction (3 and 6 months only), intentions to be active, and motivational regulations for exercise. Blood pressure and weight were assessed at baseline and 6 months. Results Perceptions of the autonomy support provided by the health and fitness advisor (HFA) did not differ by arm. Between group changes over the 6-months revealed significant differences for reported anxiety only. Within arm contrasts revealed significant improvements in anxiety and most of the Dartmouth CO-OP domains in the SDT arm at 6 months, which were not seen in the standard exercise referral group. A process model depicting hypothesized relationships between advisor autonomy support, need satisfaction and more autonomous motivation, enhanced well being and PA engagement at follow up was supported. Conclusions Significant gains in physical activity and improvements in quality of life and well-being outcomes emerged

Recruiting Unmotivated Smokers into a Smoking Induction Trial

Science.gov (United States)

Harris, Kari Jo; Bradley-Ewing, Andrea; Goggin, Kathy; Richter, Kimber P.; Patten, Christi; Williams, Karen; Lee, Hyoung S.; Staggs, Vincent S.; Catley, Delwyn

2016-01-01

Little is known about effective methods to recruit unmotivated smokers into cessation induction trials, the reasons unmotivated smokers agree to participate, and the impact of those reasons on study outcomes. A mixed-method approach was used to examine recruitment data from a randomized controlled cessation induction trial that enrolled 255 adult…

Reward-prospect interacts with trial-by-trial preparation for potential distraction.

Science.gov (United States)

Marini, Francesco; van den Berg, Berry; Woldorff, Marty G

2015-02-01

When attending for impending visual stimuli, cognitive systems prepare to identify relevant information while ignoring irrelevant, potentially distracting input. Recent work (Marini et al., 2013) showed that a supramodal distracter-filtering mechanism is invoked in blocked designs involving expectation of possible distracter stimuli, although this entails a cost ( distraction-filtering cost ) on speeded performance when distracters are expected but not presented. Here we used an arrow-flanker task to study whether an analogous cost, potentially reflecting the recruitment of a specific distraction-filtering mechanism, occurs dynamically when potential distraction is cued trial-to-trial ( cued distracter-expectation cost ). In order to promote the maximal utilization of cue information by participants, in some experimental conditions the cue also signaled the possibility of earning a monetary reward for fast and accurate performance. This design also allowed us to investigate the interplay between anticipation for distracters and anticipation of reward, which is known to engender attentional preparation. Only in reward contexts did participants show a cued distracter-expectation cost, which was larger with higher reward prospect and when anticipation for both distracters and reward were manipulated trial-to-trial. Thus, these results indicate that reward prospect interacts with the distracter expectation during trial-by-trial preparatory processes for potential distraction. These findings highlight how reward guides cue-driven attentional preparation.

The research and application of new screw-type well cover for injection well

International Nuclear Information System (INIS)

Yuan Yuan; Wang Haifeng; Gan Nan; Xu Ying

2014-01-01

Basing on the hydrogeological conditions and the working environment, a new screw-type of well cover for injection well had been designed which is suitable for high injection pressure. The well cover adopted stainless steel pipe and PVC pipe which can prevent the leakage of solution for long time because of sulfuric corrosion. The well cover was operated stably under l.5 MPa injection pressure during two-years trial. It was in low cost and had the advantages of good sealing and high reliability. The problem of lixiviant injection under high artesian water pressure was solved successfully. (authors)

Clinical Trials

Medline Plus

Full Text Available ... approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ...

Unifying distribution functions: some lesser known distributions.

Science.gov (United States)

Moya-Cessa, J R; Moya-Cessa, H; Berriel-Valdos, L R; Aguilar-Loreto, O; Barberis-Blostein, P

2008-08-01

We show that there is a way to unify distribution functions that describe simultaneously a classical signal in space and (spatial) frequency and position and momentum for a quantum system. Probably the most well known of them is the Wigner distribution function. We show how to unify functions of the Cohen class, Rihaczek's complex energy function, and Husimi and Glauber-Sudarshan distribution functions. We do this by showing how they may be obtained from ordered forms of creation and annihilation operators and by obtaining them in terms of expectation values in different eigenbases.

Yoga, breast cancer-related lymphoedema and well-being: A descriptive report of women's participation in a clinical trial.

Science.gov (United States)

Loudon, Annette; Barnett, Tony; Williams, Andrew

2017-12-01

To describe the experiences of women taking part in a yoga intervention trial for breast cancer-related lymphoedema. Around 20% of women will experience lymphoedema as a consequence of treatment for breast cancer. Specialist lymphoedema clearing, along with self-management, remains the mainstay of therapy. Yoga, an increasingly popular complementary therapeutic practice, may provide another tool to augment self-management. A qualitative, descriptive design. Interviews were conducted with 15 women with stage one breast cancer-related lymphoedema who had completed an 8-week yoga intervention trial. The intervention consisted of a weekly teacher-led 1.5-hr yoga class and a daily home practice using a 45-min DVD. Interviews were audio-taped and transcribed. These data were then analysed using an iterative-thematic approach. Participants reported improved well-being, increased awareness of their physical body as well as improved physical, mental and social functioning. They gained from being part of the yoga group that also provided a forum for them to share their experiences. Nine women felt empowered to describe their yoga participation as a transformative journey through illness. When safe to do so, the holistic practice of yoga may augment and provide additional benefit to current self-management and treatment practices for women with breast cancer-related lymphoedema. Patients with breast cancer-related lymphoedema may seek advice and guidance from nurses and other healthcare professionals on a range of complementary therapies to help relieve symptoms and promote recovery. Patients who choose to augment their treatment of breast cancer-related lymphoedema by practicing yoga should be carefully assessed, be taught an appropriate technique by a qualified yoga teacher/therapist and its impact monitored by their yoga teacher/therapist, breast care nurse, lymphoedema therapist or treating clinician. © 2017 John Wiley & Sons Ltd.

Bevacizumab plus capecitabine in patients with progressive advanced well-differentiated neuroendocrine tumors of the gastro-intestinal (GI-NETs) tract (BETTER trial)--a phase II non-randomised trial.

Science.gov (United States)

Mitry, Emmanuel; Walter, Thomas; Baudin, Eric; Kurtz, Jean-Emmanuel; Ruszniewski, Philippe; Dominguez-Tinajero, Sophie; Bengrine-Lefevre, Leïla; Cadiot, Guillaume; Dromain, Clarisse; Farace, Françoise; Rougier, Philippe; Ducreux, Michel

2014-12-01

Gastro-intestinal neuroendocrine tumours (GI-NETs) are chemotherapy-resistant tumours. Bevacizumab, an inhibitor of vascular endothelial growth factor (VEGF), has shown promising results in several phase II trials of gastro-entero-pancreatic-NETs. We assessed bevacizumab combined with capecitabine, specifically in GI-NET patients. BEvacizumab in The Treament of neuroEndocrine tumoRs (BETTER) was a multicentre, open-label, non-randomised, two-group phase II trial. Here we present the group of patients with progressive, metastatic, well-differentiated GI-NETs. Patients Eastern Cooperative Oncology Group-performance status (ECOG-PS)⩽2, Ki-67 proliferation rate <15% and no prior systemic chemotherapy were treated with bevacizumab (7.5 mg/kg/q3w) and capecitabine (1000 mg/m2 twice daily, orally d1-14, resumed on d22) for 6-24 months. The primary end-point was progression-free survival (PFS); secondary end-points included overall survival (OS), response rate, safety and quality of life. Of the 49 patients included, 53% were men, median age was 60 years (41-82), primary tumour site was ileal in 82% patients and Ki-67 was <15% in 48 patients and not available for one patient. After a maximum of 24 month follow-up per patient, the median PFS by investigator assessment was 23.4 months [95% confidence interval (CI): 13.2; not reached] and the overall disease control rate was 88% (18% partial response, 70% stable disease). The 2-year survival rate was 85%. Median OS was not reached. The most frequent grade 3-4 adverse events were hypertension (31%), diarrhoea (14%) and hand-foot syndrome (10%). The combination of bevacizumab and capecitabine showed clinical activity and a manageable safety profile in the treatment of GI-NETs that warrant confirmation in a randomised phase III trial. Copyright © 2014 Elsevier Ltd. All rights reserved.

A novel dynamic exercise initiative for older people to improve health and well-being: study protocol for a randomised controlled trial.

Science.gov (United States)

Sales, Myrla Patricia Reis; Polman, Remco; Hill, Keith D; Karaharju-Huisman, Tuire; Levinger, Pazit

2015-06-24

Exercise is an important and effective approach to preventing falls in older people, but adherence to exercise participation remains a persistent problem. A unique purpose-built exercise park was designed to provide a fun but physically challenging environment to support exercise in a community setting. This project is a randomised controlled trial designed to evaluate the effectiveness of an exercise intervention using an exercise park specifically designed for older people in reducing the risk of falls. This study will be a parallel randomised control trial with pre and post intervention design. One hundred and twenty people aged between 60 and 90 years old will be recruited from Melbourne suburbs and will be randomly allocated to either an exercise park intervention group (EPIG) or a control group (CG). The CG will receive social activities and an educational booklet on falls prevention. The BOOMER balance test will be used as the primary outcome measure. Secondary outcome measures will include hand grip strength, two minute walk test, lower limb strength test, spatio-temporal walking parameters, health related quality of life, feasibility, adherence, safety, and a number of other psychosocial measures. Outcome assessment will be conducted at baseline and at 18 and 26 weeks after intervention commencement. Participants will inform their falls and physical activity history for a 12-month period via monthly calendars. Mixed linear modelling incorporating intervention and control groups at the baseline and two follow up time points (18 weeks and 26 weeks after intervention commencement) will be used to assess outcomes. This planned trial will be the first to provide evidence if the exercise park can improve functional and physiological health, psychological and well-being. In addition, this study will provide empirical evidence for effectiveness and explore the barriers to participation and the acceptability of the senior exercise park in the Australian older

77 FR 31642 - Hawker Beech Craft Defense Company, LLC, Also Known As Hawker Beechcraft Corporation, Also Known...

Science.gov (United States)

2012-05-29

... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,901] Hawker Beech Craft Defense Company, LLC, Also Known As Hawker Beechcraft Corporation, Also Known As Hawker Beechcraft International SVC, Also Known As Rapid Surplus Parts, Also Known As Hawker Beechcraft Svcs, Also Known As Travel...

Prevention of Contrast-Induced AKI: A Review of Published Trials and the Design of the Prevention of Serious Adverse Events following Angiography (PRESERVE) Trial

Science.gov (United States)

Gallagher, Martin; Kaufman, James; Cass, Alan; Parikh, Chirag R.; Chertow, Glenn M.; Shunk, Kendrick A.; McCullough, Peter A.; Fine, Michael J.; Mor, Maria K.; Lew, Robert A.; Huang, Grant D.; Conner, Todd A.; Brophy, Mary T.; Lee, Joanne; Soliva, Susan; Palevsky, Paul M.

2013-01-01

Summary Contrast-induced AKI (CI-AKI) is a common condition associated with serious, adverse outcomes. CI-AKI may be preventable because its risk factors are well characterized and the timing of renal insult is commonly known in advance. Intravenous (IV) fluids and N-acetylcysteine (NAC) are two of the most widely studied preventive measures for CI-AKI. Despite a multitude of clinical trials and meta-analyses, the most effective type of IV fluid (sodium bicarbonate versus sodium chloride) and the benefit of NAC remain unclear. Careful review of published trials of these interventions reveals design limitations that contributed to their inconclusive findings. Such design limitations include the enrollment of small numbers of patients, increasing the risk for type I and type II statistical errors; the use of surrogate primary endpoints defined by small increments in serum creatinine, which are associated with, but not necessarily causally related to serious, adverse, patient-centered outcomes; and the inclusion of low-risk patients with intact baseline kidney function, yielding low event rates and reduced generalizability to a higher-risk population. The Prevention of Serious Adverse Events following Angiography (PRESERVE) trial is a randomized, double-blind, multicenter trial that will enroll 8680 high-risk patients undergoing coronary or noncoronary angiography to compare the effectiveness of IV isotonic sodium bicarbonate versus IV isotonic sodium chloride and oral NAC versus oral placebo for the prevention of serious, adverse outcomes associated with CI-AKI. This article discusses key methodological issues of past trials investigating IV fluids and NAC and how they informed the design of the PRESERVE trial. PMID:23660180

Public titles of clinical trials should have ethics review.

Science.gov (United States)

Saenz, Carla; Reveiz, Ludovic; Tisdale, John F

2015-09-01

A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects. Copyright © 2015 Pan American Health Organization. Published by Elsevier Inc. All rights reserved.

Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

Science.gov (United States)

Dawson, Liza; Zwerski, Sheryl

2015-06-01

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Process evaluation of the Walk Well study: a cluster-randomised controlled trial of a community based walking programme for adults with intellectual disabilities

Directory of Open Access Journals (Sweden)

Lynsay Matthews

2016-07-01

Full Text Available Abstract Background Walking interventions can be effective in encouraging sedentary populations to become more active; however, limited research has explored the effectiveness of walking interventions for adults with intellectual disabilities. This process evaluation explored the delivery of a community based walking intervention for adults with intellectual disabilities. Methods Walk Well was a single-blind cluster randomised controlled trial of a 12-week physical activity consultation-led walking intervention. 102 participants were randomised to the Walk Well intervention or a waiting list control group. Participants in the intervention group received three physical activity consultations with a walking advisor at baseline, 6 & 12-weeks. They were encouraged to use a pedometer to set goals and monitor their daily step count. Primary outcome was change in daily step count at 12-weeks. Process evaluation measures included qualitative interviews with key stakeholders (n = 6 and quantifiable data collected as part of the intervention. Additional process data were extracted from a sub-set of qualitative interviews with participants and carers (n = 20. Data were analysed for process information related to context, recruitment and retention, reach, implementation, and fidelity. Results Walk Well was not effective in significantly increasing levels of physical activity. The process evaluation did, however, highlight several important areas for consideration in future studies, including: a successful recruitment and retention strategy reaching a representative sample of adults with intellectual disabilities in the community; feasible and (for most enjoyable methods of engaging adults with intellectual disabilities in activities to support behaviour change; potential need for greater intervention duration and frequency of contact; advantages and disadvantages of using pedometers as a behaviour change tool; the need for strategies which engage

Clinical Trials

Medline Plus

Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

Effectiveness of an Energy Management Training Course on Employee Well-Being: A Randomized Controlled Trial.

Science.gov (United States)

Das, Sai Krupa; Mason, Shawn T; Vail, Taylor A; Rogers, Gail V; Livingston, Kara A; Whelan, Jillian G; Chin, Meghan K; Blanchard, Caroline M; Turgiss, Jennifer L; Roberts, Susan B

2018-01-01

Programs focused on employee well-being have gained momentum in recent years, but few have been rigorously evaluated. This study evaluates the effectiveness of an intervention designed to enhance vitality and purpose in life by assessing changes in employee quality of life (QoL) and health-related behaviors. A worksite-based randomized controlled trial. Twelve eligible worksites (8 randomized to the intervention group [IG] and 4 to the wait-listed control group [CG]). Employees (n = 240) at the randomized worksites. A 2.5-day group-based behavioral intervention. Rand Medical Outcomes Survey (MOS) 36-item Short-Form (SF-36) vitality and QoL measures, Ryff Purpose in Life Scale, Center for Epidemiologic Studies questionnaire for depression, MOS sleep, body weight, physical activity, diet quality, and blood measures for glucose and lipids (which were used to calculate a cardiometabolic risk score) obtained at baseline and 6 months. General linear mixed models were used to compare least squares means or prevalence differences in outcomes between IG and CG participants. As compared to CG, IG had a significantly higher mean 6-month change on the SF-36 vitality scale ( P = .003) and scored in the highest categories for 5 of the remaining 7 SF-36 domains: general health ( P = .014), mental health ( P = .027), absence of role limitations due to physical problems ( P = .026), and social functioning ( P = .007). The IG also had greater improvements in purpose in life ( P employee QoL and well-being over 6 months.

Insomnia and Well-Being

Science.gov (United States)

Hamilton, Nancy A.; Gallagher, Matthew W.; Preacher, Kristopher J.; Stevens, Natalie; Nelson, Christy A.; Karlson, Cynthia; McCurdy, Danyale

2007-01-01

Most Americans have occasional problems with insomnia. The relationship of insomnia to illness is well known. However, insomnia may also relate to lower levels of well-being. Although there are various definitions of well-being, one of the most clearly articulated and comprehensive models identifies 2 overarching constructs, psychological…

Decomposition of Some Well-Known Variance Reduction Techniques. Revision.

Science.gov (United States)

1985-05-01

34use a family of transformatlom to convert given samples into samples conditioned on a given characteristic (p. 04)." Dub and Horowitz (1979), Granovsky ...34Antithetic Varlates Revisited," Commun. ACM 26, 11, 064-971. Granovsky , B.L. (1981), "Optimal Formulae of the Conditional Monte Carlo," SIAM J. Alg

Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED trial: A multi-centre, double-masked, factorial randomised controlled trial

Directory of Open Access Journals (Sweden)

Kingston Laura

2008-01-01

Full Text Available Abstract Background Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed. The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease. Methods/design Patients with active thyroid eye disease will be randomised to receive (i azathioprine or oral placebo and (ii radiotherapy or sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure at 12 months and secondary end-points include quality of life scores and health economic measures. Discussion The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b constructing effective inclusion and exclusion criteria to select for active disease; and (c selecting pragmatic outcome measures. Trial registration Current controlled trials

Novel Method for Recruiting Representative At-Risk Individuals into Cancer Prevention Trials: Online Health Risk Assessment in Employee Wellness Programs.

Science.gov (United States)

Hui, Siu-Kuen Azor; Miller, Suzanne M; Hazuda, Leah; Engelman, Kimberly; Ellerbeck, Edward F

2016-09-01

Participation in cancer prevention trials (CPT) is lower than 3 % among high-risk healthy individuals, and racial/ethnic minorities are the most under-represented. Novel recruitment strategies are therefore needed. Online health risk assessment (HRA) serves as a gateway component of nearly all employee wellness programs (EWPs) and may be a missed opportunity. This study aimed to explore employees' interest, willingness, motivators, and barriers of releasing their HRA responses to an external secure research database for recruitment purpose. We used qualitative research methods (focus group and individual interviews) to examine employees' interest and willingness in releasing their online HRA responses to an external, secure database to register as potential CPT participants. Fifteen structured interviews (40 % of study participants were of racial/ethnic minority) were conducted, and responses reached saturation after four interviews. All employees showed interest and willingness to release their online HRA responses to register as a potential CPT participant. Content analyses revealed that 91 % of participants were motivated to do so, and the major motivators were to (1) obtain help in finding personally relevant prevention trials, (2) help people they know who are affected by cancer, and/or (3) increase knowledge about CPT. A subset of participants (45 %) expressed barriers of releasing their HRA responses due to concerns about credibility and security of the external database. Online HRA may be a feasible but underutilized recruitment method for cancer prevention trials. EWP-sponsored HRA shows promise for the development of a large, centralized registry of racially/ethnically representative CPT potential participants.

Effects of a standard provision versus an autonomy supportive exercise referral programme on physical activity, quality of life and well-being indicators: a cluster randomised controlled trial.

Science.gov (United States)

Duda, Joan L; Williams, Geoffrey C; Ntoumanis, Nikos; Daley, Amanda; Eves, Frank F; Mutrie, Nanette; Rouse, Peter C; Lodhia, Rekha; Blamey, Ruth V; Jolly, Kate

2014-01-29

The National Institute for Health and Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the feasibility and impact of a Self Determination Theory-based (SDT) exercise referral consultation. An exploratory cluster randomised controlled trial comparing standard provision exercise referral with an exercise referral intervention grounded in Self Determination Theory. Individuals (N = 347) referred to an exercise referral scheme were recruited into the trial from 13 centres.Outcomes and processes of change measured at baseline, 3 and 6-months: Minutes of self-reported moderate or vigorous physical activity (PA) per week (primary outcome), health status, positive and negative indicators of emotional well-being, anxiety, depression, quality of life (QOL), vitality, and perceptions of autonomy support from the advisor, need satisfaction (3 and 6 months only), intentions to be active, and motivational regulations for exercise.Blood pressure and weight were assessed at baseline and 6 months. Perceptions of the autonomy support provided by the health and fitness advisor (HFA) did not differ by arm. Between group changes over the 6-months revealed significant differences for reported anxiety only. Within arm contrasts revealed significant improvements in anxiety and most of the Dartmouth CO-OP domains in the SDT arm at 6 months, which were not seen in the standard exercise referral group. A process model depicting hypothesized relationships between advisor autonomy support, need satisfaction and more autonomous motivation, enhanced well being and PA engagement at follow up was supported. Significant gains in physical activity and improvements in quality of life and well-being outcomes emerged in both the standard provision exercise

Wellness program for anesthesiology residents: a randomized, controlled trial.

Science.gov (United States)

Saadat, H; Snow, D L; Ottenheimer, S; Dai, F; Kain, Z N

2012-10-01

Multiple reports illustrate the deleterious effects of stress on physicians' mental and physical health, as well as on patient care. This study evaluates the effects of a wellness program on anesthesiology residents' well-being. Sixty residents were randomly assigned to one of three groups: (1) wellness intervention group, (2) no-treatment control with release time, and (3) no-treatment control with routine duties. Coping, stressors, social support, psychological symptoms, and alcohol and tobacco use were measured using a pre-test-post-test design. Residents in the wellness program reported significantly fewer stressors in their role as parent, increased social support at work, greater problem-solving coping, and less anxiety as compared with one or both of the control groups. Findings related to reducing avoidance coping and alcohol consumption also were suggestive of positive intervention effects. An intervention to increase the use of active coping and social support, to reduce reliance on avoidance coping, and to decrease work and family stressors had an overall pattern of beneficial effects on residents' well-being. The importance of offering such programs during residency training, ways to strengthen intervention effectiveness, and areas for future research are discussed. © 2012 The Authors. Acta Anaesthesiologica Scandinavica © 2012 The Acta Anaesthesiologica Scandinavica Foundation.

Walk well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol

Science.gov (United States)

2013-01-01

Background Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. Methods/design This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme. A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Discussion Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities. Trial registration ISRCTN: ISRCTN50494254 PMID:23816316

Whose data set is it anyway? Sharing raw data from randomized trials

Directory of Open Access Journals (Sweden)

Vickers Andrew J

2006-05-01

Full Text Available Abstract Background Sharing of raw research data is common in many areas of medical research, genomics being perhaps the most well-known example. In the clinical trial community investigators routinely refuse to share raw data from a randomized trial without giving a reason. Discussion Data sharing benefits numerous research-related activities: reproducing analyses; testing secondary hypotheses; developing and evaluating novel statistical methods; teaching; aiding design of future trials; meta-analysis; and, possibly, preventing error, fraud and selective reporting. Clinical trialists, however, sometimes appear overly concerned with being scooped and with misrepresentation of their work. Both possibilities can be avoided with simple measures such as inclusion of the original trialists as co-authors on any publication resulting from data sharing. Moreover, if we treat any data set as belonging to the patients who comprise it, rather than the investigators, such concerns fall away. Conclusion Technological developments, particularly the Internet, have made data sharing generally a trivial logistical problem. Data sharing should come to be seen as an inherent part of conducting a randomized trial, similar to the way in which we consider ethical review and publication of study results. Journals and funding bodies should insist that trialists make raw data available, for example, by publishing data on the Web. If the clinical trial community continues to fail with respect to data sharing, we will only strengthen the public perception that we do clinical trials to benefit ourselves, not our patients.

Whose data set is it anyway? Sharing raw data from randomized trials.

Science.gov (United States)

Vickers, Andrew J

2006-05-16

Sharing of raw research data is common in many areas of medical research, genomics being perhaps the most well-known example. In the clinical trial community investigators routinely refuse to share raw data from a randomized trial without giving a reason. Data sharing benefits numerous research-related activities: reproducing analyses; testing secondary hypotheses; developing and evaluating novel statistical methods; teaching; aiding design of future trials; meta-analysis; and, possibly, preventing error, fraud and selective reporting. Clinical trialists, however, sometimes appear overly concerned with being scooped and with misrepresentation of their work. Both possibilities can be avoided with simple measures such as inclusion of the original trialists as co-authors on any publication resulting from data sharing. Moreover, if we treat any data set as belonging to the patients who comprise it, rather than the investigators, such concerns fall away. Technological developments, particularly the Internet, have made data sharing generally a trivial logistical problem. Data sharing should come to be seen as an inherent part of conducting a randomized trial, similar to the way in which we consider ethical review and publication of study results. Journals and funding bodies should insist that trialists make raw data available, for example, by publishing data on the Web. If the clinical trial community continues to fail with respect to data sharing, we will only strengthen the public perception that we do clinical trials to benefit ourselves, not our patients.

Practical trials in medical education

DEFF Research Database (Denmark)

Tolsgaard, Martin G; Kulasegaram, Kulamakan M; Ringsted, Charlotte

2017-01-01

participants across several settings and (iii) multiple outcome measures with long-term follow-up to evaluate both benefits and risks. Questions posed by practical trials may be proactive in applying theory in the development of educational innovations or reactive to educational reforms and innovations. Non......CONTEXT: Concerns have been raised over the gap between education theory and practice and how research can contribute to inform decision makers on their choices and priorities. Little is known about how educational theories and research outcomes produced under optimal conditions in highly...... controlled settings generalise to the real-life education context. One way of bridging this gap is applying the concept of practical trials in medical education. In this paper we elaborate on characteristics of practical trials and based on examples from medical education we discuss the challenges...

Health disparities and clinical trial recruitment: Is there a duty to tweet?

Science.gov (United States)

Friesen, Phoebe

2017-01-01

While it is well known that the homogeneity of clinical trial participants often threatens the goal of attaining generalizable knowledge, researchers often cite issues with recruitment, including a lack of interest from participants, shortages of resources, or difficulty accessing particular populations, to explain the lack of diversity within sampling. It is proposed that social media might provide an opportunity to overcome these obstacles through affordable, targeted recruitment advertisements or messages. Recruiters are warned, however, to be cautious using these means, since risks related to privacy and transparency can take on a new hue. PMID:28249024

Randomized controlled trial of an online mother-daughter body image and well-being intervention.

Science.gov (United States)

Diedrichs, Phillippa C; Atkinson, Melissa J; Garbett, Kirsty M; Williamson, Heidi; Halliwell, Emma; Rumsey, Nichola; Leckie, George; Sibley, Chris G; Barlow, Fiona Kate

2016-09-01

Poor body image is a public health issue. Mothers are a key influence on adolescent girls' body image. This study evaluated an accessible, scalable, low-intensity internet-based intervention delivered to mothers (Dove Self Esteem Project Website for Parents) on mothers' and their adolescent daughters' body image and psychosocial well-being. British mother-daughter dyads (N = 235) participated in a cluster randomized controlled trial (assessment-only control; mothers viewed the website without structured guidance [website-unstructured]; mothers viewed the website via a tailored pathway [website-tailored]). Dyads completed standardized self-report measures of body image, related risk factors, and psychosocial outcomes at baseline, 2 weeks post-exposure, 6-week, and 12-month follow-up. Dyadic models showed that relative to the control, mothers who viewed the website reported significantly higher self-esteem at post-exposure (website-tailored), higher weight esteem at 6-week follow-up (website-tailored), lower negative affect at 12-month follow-up (website-tailored), engaged in more self-reported conversations with their daughters about body image at post-exposure and 6-week follow-up, and were 3-4.66 times more likely to report seeking additional support for body image issues at post-exposure (website-tailored), 6-week, and 12-month (website-tailored) follow-up. Daughters whose mothers viewed the website had higher self-esteem and reduced negative affect at 6-week follow-up. There were no differences on daughters' body image, and risk factors among mothers or daughters, at post-exposure or follow-up. Tailoring website content appeared beneficial. This intervention offers a promising 'first-step' toward improving psychosocial well-being among mothers and daughters. In order to further optimize the intervention, future research to improve body image-related outcomes and to understand mechanisms for change would be beneficial. (PsycINFO Database Record (c) 2016 APA, all

The effects of an oral multivatimin combination with calcium, magnesium, and zinc on psychological well-being in healthy young male volunteers: A double-blind placebo-controlled trial.

NARCIS (Netherlands)

Carroll, D.; Ring, C.; Suter, M.; Willemsen, A.H.M.

2000-01-01

Rationale: Vitamin and mineral supplements may be associated with improved psychological status. Objective: The present study tested the effects of a multivitamin and mineral supplement (Berocca®) on psychological well-being. Methods: In a double-blind randomised-control trial, 80 healthy male

Reasons for participating in a randomised clinical trial: The volunteers' voices in the COSTOP trial in Uganda

Directory of Open Access Journals (Sweden)

Agnes Ssali

2017-09-01

Full Text Available Introduction: The reasons why research participants join clinical trials remains an area of inquiry especially in low and middle income countries. Methods: We conducted exit interviews with participants who took part in a trial which aimed to evaluate whether long term prophylaxis with cotrimoxazole can be safely discontinued among adults who have been stabilised on antiretroviral therapy (ART. Participants were all reported to be stable on ART and had been participating in the trial for between 12 and 36 months; at the end of the trial participants were interviewed using a semi-structured questionnaire. One of the objectives of the exit interview was to find out what motivated the participants to join the research. Results: Participants gave personal reasons for joining the trial, frequently linked to their health and well-being as well as reduction of pill burden. Conclusion: We conclude that underlying reasons for joining clinical trials may extend beyond or can be different from the rationale given to the participants before enrolment by the research team. The reasons that motivate enrolment to clinical trials and research in general require further investigation in different settings. Trial registration number: ISRCTN44723643. Keywords: Randomised clinical trials, Volunteers, Participants

Clinical Trials

Medline Plus

Full Text Available ... medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these ... trials are a key research tool for advancing medical knowledge and patient care. ...

Six-year positive effects of a mindfulness-based intervention on mindfulness, coping and well-being in medical and psychology students; Results from a randomized controlled trial

Science.gov (United States)

Rosenvinge, Jan H.; Tyssen, Reidar; Hanley, Adam; Garland, Eric

2018-01-01

Longitudinal research investigating the enduring impact of mindfulness training is scarce. This study investigates the six-year effects of a seven-week mindfulness-based course, by studying intervention effects in the trajectory of dispositional mindfulness and coping skills, and the association between those change trajectories and subjective well-being at six-year follow-up. 288 Norwegian medical and psychology students participated in a randomized controlled trial. 144 received a 15-hour mindfulness course over seven weeks in the second or third semester with booster sessions twice yearly, while the rest continued their normal study curricula. Outcomes were subjective well-being, and dispositional mindfulness and coping assessed using the Five Facet Mindfulness Questionnaire and the Ways of Coping Checklist. Analyses were performed for the intention-to-treat sample, using latent growth curve models. At six-year follow-up, students receiving mindfulness training reported increased well-being. Furthermore, they reported greater increases in the trajectory of dispositional mindfulness and problem-focused coping along with greater decreases in the trajectory of avoidance-focused coping. Increases in problem-focused coping predicted increases in well-being. These effects were found despite relatively low levels of adherence to formal mindfulness practice. The findings demonstrate the viability of mindfulness training in the promotion of well-being and adaptive coping, which could contribute to the quality of care given, and to the resilience and persistence of health care professionals. Trial registration: Clinicaltrials.gov NCT00892138 PMID:29689081

Clinical Trials

Medline Plus

Full Text Available ... new treatments in small groups of people for safety and side effects. Phase II clinical trials look at how well treatments work and further review these treatments for safety. Phase ...

Clinical trials of homoeopathy.

Science.gov (United States)

Kleijnen, J; Knipschild, P; ter Riet, G

1991-01-01

OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

Sleeping Well Trial: Increasing the effectiveness of treatment with continuous positive airway pressure using a weight management program in overweight adults with obstructive sleep apnoea-A stepped wedge randomised trial protocol.

Science.gov (United States)

Truby, Helen; Edwards, Bradley A; O'Driscoll, Denise M; Young, Alan; Ghazi, Ladan; Bristow, Claire; Roem, Kerryn; Bonham, Maxine P; Murgia, Chiara; Day, Kaitlin; Haines, Terry P; Hamilton, Garun S

2018-05-24

The majority of adults diagnosed with obstructive sleep apnoea (OSA) are overweight or obese. Continuous positive airway pressure (CPAP) is the most common effective therapy for OSA. However, adherence declines over time with only 50% of patients prescribed CPAP continuing to use it long term. Furthermore, a recent prospective analysis indicated that those more adherent with CPAP therapy have enhanced weight gain trajectories which in turn may negatively impact their OSA. The Sleeping Well Trial aims to establish whether the timing of starting a lifestyle weight loss intervention impacts on weight trajectory in those with moderate-severe OSA treated at home with CPAP, while testing the potential for smart phone technology to improve adherence with lifestyle interventions. A stepped wedge design with randomisation of individuals from 1 to 6 months post-enrolment, with 5 months of additional prospective follow up after completion of the stepped wedge. This design will investigate the effect of the 6-month lifestyle intervention on people undergoing CPAP on body weight, body composition and health-related quality of life. This trial tests whether the timing of supporting the patient through a weight loss intervention is important in obtaining the maximum benefit of a lifestyle change and CPAP usage, and identify how best to support patients through this critical period. The protocol (v1) is registered prospectively with the International Clinical Trials Registry (CTR) ACTRN12616000203459 (public access). Any amendments to protocol will be documented via the CTR. Recruitment commenced in March 2016 with data collection scheduled to finish by May 2018. © 2018 Dietitians Association of Australia.

Well-plate freeze-drying

DEFF Research Database (Denmark)

Trnka, Hjalte; Rantanen, Jukka; Grohganz, Holger

2015-01-01

Abstract Context: Freeze-drying in presence of excipients is a common practice to stabilize biomacromolecular formulations. The composition of this formulation is known to affect the quality of the final product. Objective: The aim of this study was to evaluate freeze-drying in well-plates as a h......Abstract Context: Freeze-drying in presence of excipients is a common practice to stabilize biomacromolecular formulations. The composition of this formulation is known to affect the quality of the final product. Objective: The aim of this study was to evaluate freeze-drying in well......-plates as a high throughput platform for formulation screening of freeze-dried products. Methods: Model formulations consisting of mannitol, sucrose and bovine serum albumin were freeze-dried in brass well plates, plastic well plates and vials. Physical properties investigated were solid form, residual moisture......, cake collapse and reconstitution time. Results: Samples freeze-dried in well-plates had an acceptable visual cake appearance. Solid form analysis by high throughput X-ray powder diffraction indicated comparable polymorphic outcome independent of the container. The expected increase in moisture level...

The Bipolar Interactive Psychoeducation (BIPED study: trial design and protocol

Directory of Open Access Journals (Sweden)

Jones Ian

2009-08-01

Full Text Available Abstract Background Bipolar disorders affect between 3–5% of the population and are associated with considerable lifelong impairment. Since much of the morbidity associated with bipolar disorder is caused by recurrent depressive symptoms, which are often only poorly responsive to antidepressants, there is a need to develop alternative, non-pharmacological interventions. Psychoeducational interventions have emerged as promising long-term therapeutic options for bipolar disorder. Methods/design The study is an exploratory, individually randomised controlled trial. The intervention known as 'Beating Bipolar' is a psychoeducational programme which is delivered via a novel web-based system. We will recruit 100 patients with a diagnosis of DSM-IV bipolar disorder (including type I and type II currently in clinical remission. The primary outcome is quality of life. This will be compared for those patients who have participated in the psychoeducational programme with those who received treatment as usual. Quality of life will be assessed immediately following the intervention as well as 10 months after randomisation. Secondary outcomes include current depressive and manic symptoms, number of episodes of depression and mania/hypomania experienced during the follow-up period, global functioning, functional impairment and insight. An assessment of costs and a process evaluation will also be conducted which will explore the feasibility and acceptability of the intervention as well as potential barriers to effectiveness. Discussion Bipolar disorder is common, under-recognised and often poorly managed. It is a chronic, life-long, relapsing condition which has an enormous impact on the individual and the economy. This trial will be the first to explore the effectiveness of a novel web-based psychoeducational intervention for patients with bipolar disorder which has potential to be easily rolled out to patients. Trial registration Current Controlled Trials

Solution-Focused Wellness: A Randomized Controlled Trial of College Students.

Science.gov (United States)

Beauchemin, James D

2018-05-01

Heightened stress levels and compromised well-being are common among college students. Current trends on college campuses include an increase in the number of students experiencing mental health issues and an increase in students seeking help, illustrating a need for evidence-based brief interventions that improve student wellness. This research study used a randomized controlled study design to examine the effects of a short-term (seven-week), solution-focused wellness intervention on perceived stress and wellness of college students. Repeated measures analysis of variance results demonstrated that the effect of group membership across time was significant for both perceived wellness and stress (p < .01). Effect sizes using partial eta2 statistics were large for both outcome variables. Findings indicate that a brief solution-focused wellness intervention can significantly improve perceptions of wellness and reduce stress among college students and is more effective than treatment as usual. Intervention replicability allows for dissemination across varied academic groups and locations, and potential generalization across populations.

Efficacy of a Web-Based Guided Recommendation Service for a Curated List of Readily Available Mental Health and Well-Being Mobile Apps for Young People: Randomized Controlled Trial.

Science.gov (United States)

Bidargaddi, Niranjan; Musiat, Peter; Winsall, Megan; Vogl, Gillian; Blake, Victoria; Quinn, Stephen; Orlowski, Simone; Antezana, Gaston; Schrader, Geoffrey

2017-05-12

Mental disorders are highly prevalent for the people who are aged between 16 and 25 years and can permanently disrupt the development of these individuals. Easily available mobile health (mHealth) apps for mobile phones have great potential for the prevention and early intervention of mental disorders in young adults, but interventions are required that can help individuals to both identify high-quality mobile apps and use them to change health and lifestyle behavior. The study aimed to assess the efficacy of a Web-based self-guided app recommendation service ("The Toolbox") in improving the well-being of young Australians aged between 16 and 25 years. The intervention was developed in collaboration with young adults and consists of a curated list of 46 readily available health and well-being apps, assessed and rated by professionals and young people. Participants are guided by an interactive quiz and subsequently receive recommendations for particular apps to download and use based on their personal goals. The study was a waitlist, parallel-arm, randomized controlled trial. Our primary outcome measure was change in well-being as measured by the Mental Health Continuum-Short Form (MHC-SF). We also employed ecological momentary assessments (EMAs) to track mood, energy, rest, and sleep. Participants were recruited from the general Australian population, via several Web-based and community strategies. The study was conducted through a Web-based platform consisting of a landing Web page and capabilities to administer study measures at different time points. Web-based measurements were self-assessed at baseline and 4 weeks, and EMAs were collected repeatedly at regular weekly intervals or ad hoc when participants interacted with the study platform. Primary outcomes were analyzed using linear mixed-models and intention-to-treat (ITT) analysis. A total of 387 participants completed baseline scores and were randomized into the trial. Results demonstrated no significant

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

Directory of Open Access Journals (Sweden)

Paul P Christopher

Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative.

Science.gov (United States)

Greenberg, Rachel G; Corneli, Amy; Bradley, John; Farley, John; Jafri, Hasan S; Lin, Li; Nambiar, Sumathi; Noel, Gary J; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials. Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.

Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

Science.gov (United States)

Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

2012-10-01

Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

Conducting clinical trials in Singapore.

Science.gov (United States)

Woo, K T

1999-04-01

All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

Young People's Experiences of Participation in Clinical Trials : Reasons for Taking Part

NARCIS (Netherlands)

Luchtenberg, Malou; Maeckelberghe, Els; Locock, Louise; Powell, Lesley; Verhagen, A. A. Eduard

2015-01-01

Given the lack of knowledge about safety and efficacy of many treatments for children, pediatric clinical trials are important, but recruitment for pediatric research is difficult. Little is known about children's perspective on participating in trials. The purpose of this study was to understand

Trial-to-trial reoptimization of motor behavior due to changes in task demands is limited.

Directory of Open Access Journals (Sweden)

Orban de Xivry J-J

Full Text Available Each task requires a specific motor behavior that is tuned to task demands. For instance, writing requires a lot of accuracy while clapping does not. It is known that the brain adjusts the motor behavior to different task demands as predicted by optimal control theory. In this study, the mechanism of this reoptimization process is investigated by varying the accuracy demands of a reaching task. In this task, the width of the reaching target (0.5 or 8 cm was varied either on a trial-to-trial basis (random schedule or in blocks (blocked schedule. On some trials, the hand of the subjects was clamped to a rectilinear trajectory that ended 2 cm on the left or right of the target center. The rejection of this perturbation largely varied with target width in the blocked schedule but not in the random schedule. That is, subjects exhibited different motor behavior in the different schedules despite identical accuracy demands. Therefore, while reoptimization has been considered immediate and automatic, the differences in motor behavior observed across schedules suggest that the reoptimization of the motor behavior is neither happening on a trial-by-trial basis nor obligatory. The absence of trial-to-trial mechanisms, the inability of the brain to adapt to two conflicting task demands and the existence of a switching cost are discussed as possible sources of the non-optimality of motor behavior during the random schedule.

Clinical Trials

Medline Plus

Full Text Available ... work best for certain illnesses or groups of people. Clinical trials produce the best data available for ... or animals doesn't always work well in people. Thus, research in humans is needed. For safety ...

Clinical Trials

Medline Plus

Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...

Using simulation to aid trial design: Ring-vaccination trials.

Directory of Open Access Journals (Sweden)

Matt David Thomas Hitchings

2017-03-01

Full Text Available The 2014-6 West African Ebola epidemic highlights the need for rigorous, rapid clinical trial methods for vaccines. A challenge for trial design is making sample size calculations based on incidence within the trial, total vaccine effect, and intracluster correlation, when these parameters are uncertain in the presence of indirect effects of vaccination.We present a stochastic, compartmental model for a ring vaccination trial. After identification of an index case, a ring of contacts is recruited and either vaccinated immediately or after 21 days. The primary outcome of the trial is total vaccine effect, counting cases only from a pre-specified window in which the immediate arm is assumed to be fully protected and the delayed arm is not protected. Simulation results are used to calculate necessary sample size and estimated vaccine effect. Under baseline assumptions about vaccine properties, monthly incidence in unvaccinated rings and trial design, a standard sample-size calculation neglecting dynamic effects estimated that 7,100 participants would be needed to achieve 80% power to detect a difference in attack rate between arms, while incorporating dynamic considerations in the model increased the estimate to 8,900. This approach replaces assumptions about parameters at the ring level with assumptions about disease dynamics and vaccine characteristics at the individual level, so within this framework we were able to describe the sensitivity of the trial power and estimated effect to various parameters. We found that both of these quantities are sensitive to properties of the vaccine, to setting-specific parameters over which investigators have little control, and to parameters that are determined by the study design.Incorporating simulation into the trial design process can improve robustness of sample size calculations. For this specific trial design, vaccine effectiveness depends on properties of the ring vaccination design and on the

Intravenous Vitamin C administration reduces fatigue in office workers: a double-blind randomized controlled trial

Directory of Open Access Journals (Sweden)

Suh Sang-Yeon

2012-01-01

Full Text Available Abstract Background Studies of the efficacy of vitamin C treatment for fatigue have yielded inconsistent results. One of the reasons for this inconsistency could be the difference in delivery routes. Therefore, we planned a clinical trial with intravenous vitamin C administration. Methods We evaluated the effect of intravenous vitamin C on fatigue in office workers. A group of 141 healthy volunteers, aged 20 to 49 years participated in this randomized, double-blind, controlled clinical trial. The trial group received 10 grams of vitamin C with normal saline intravenously, while the placebo group received normal saline only. Since vitamin C is a well-known antioxidant, oxidative stress was measured. Fatigue score, oxidative stress, and plasma vitamin C levels were measured before intervention, and again two hours and one day after intervention. Adverse events were monitored. Results The fatigue scores measured at two hours after intervention and one day after intervention were significantly different between the two groups (p = 0.004; fatigue scores decreased in the vitamin C group after two hours and remained lower for one day. Trial also led to higher plasma vitamin C levels and lower oxidative stress compared to the placebo group (p Conclusion Thus, intravenous vitamin C reduced fatigue at two hours, and the effect persisted for one day. There were no significant differences in adverse events between two groups. High dose intravenous vitamin C proved to be safe and effective against fatigue in this study. Trial Registration The clinical trial registration of this trial is http://ClinicalTrials.govNCT00633581.

Clinical Trials

Medline Plus

Full Text Available ... safe a treatment is or how well it works. Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial. When ...

Militantly Well

DEFF Research Database (Denmark)

Vigh, Henrik Erdman

2015-01-01

futures that transcend conflict engagement and wartime suffering for young militiamen. It clarifies the positive prospects that are expected to lie beyond the known horrors of war. Though conflict and warfare may provide strange points of departure for talking about well-being, imaginaries of happiness...... stand out from a background of hardship and are talked about in both a quite concrete way, as a lack of insecurity, as well as in an abstract way, as realization of social being. However, for most of the people I talk to, happiness remains elusive and evades their desperate attempts to grasp it...

Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

Directory of Open Access Journals (Sweden)

K. O. Zupanets

2016-03-01

Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

Directory of Open Access Journals (Sweden)

Diana de la Iglesia

Full Text Available Clinical Trials (CTs are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano, and CTs that do not involve nanotechnology (non-nano. Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results.We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i extraction and manual annotation of CTs as nano vs. non-nano, ii pre-processing and automatic classification, and iii performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset.The performance of the best automated classifier closely matches that of experts (AUC over 0.95, suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice

A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

Science.gov (United States)

de la Iglesia, Diana; García-Remesal, Miguel; Anguita, Alberto; Muñoz-Mármol, Miguel; Kulikowski, Casimir; Maojo, Víctor

2014-01-01

Clinical Trials (CTs) are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano), and CTs that do not involve nanotechnology (non-nano). Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results. We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i) extraction and manual annotation of CTs as nano vs. non-nano, ii) pre-processing and automatic classification, and iii) performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset. The performance of the best automated classifier closely matches that of experts (AUC over 0.95), suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice, which is

The 10 most important things known about addiction.

Science.gov (United States)

Sellman, Doug

2010-01-01

If you were asked: 'What are the most important things we know about addiction?' what would you say? This paper brings together a body of knowledge across multiple domains and arranged as a list of 10 things known about addiction, as a response to such a question. The 10 things are: (1) addiction is fundamentally about compulsive behaviour; (2) compulsive drug seeking is initiated outside of consciousness; (3) addiction is about 50% heritable and complexity abounds; (4) most people with addictions who present for help have other psychiatric problems as well; (5) addiction is a chronic relapsing disorder in the majority of people who present for help; (6) different psychotherapies appear to produce similar treatment outcomes; (7) 'come back when you're motivated' is no longer an acceptable therapeutic response; (8) the more individualized and broad-based the treatment a person with addiction receives, the better the outcome; (9) epiphanies are hard to manufacture; and (10) change takes time. The paper concludes with a call for unity between warring factions in the field to use the knowledge already known more effectively for the betterment of tangata whaiora (patients) suffering from addictive disorders.

Associations between positive emotional well-being and stress-induced myocardial ischemia: Well-being scores predict exercise-induced ischemia.

Science.gov (United States)

Feigal, Jacob P; Boyle, Stephen H; Samad, Zainab; Velazquez, Eric J; Wilson, Jennifer L; Becker, Richard C; Williams, Redford B; Kuhn, Cynthia M; Ortel, Thomas L; Rogers, Joseph G; O'Connor, Christopher M; Jiang, Wei

2017-02-01

Depressive symptoms have been associated with myocardial ischemia induced by mental (MSIMI) and exercise (ESIMI) stress in clinically stable ischemic heart disease (IHD) patients, but the association between positive emotions and inducible ischemia is less well characterized. The objective of this study was to examine the associations between ratings of well-being and stress-induced ischemia. Subjects were adult patients with documented IHD underwent mental and exercise stress testing for the Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT) trial. The General Well-Being Schedule (GWBS), with higher scores reflecting greater subjective well-being, and the Center for Epidemiologic Studies Depression Scale (CES-D) were obtained from the REMIT participants. Echocardiography was used to measure ischemic responses to mental stress and Bruce protocol treadmill exercise testing. Data were analyzed using logistic regression adjusting for age, sex, resting left-ventricular ejection fraction (LVEF), and resting wall motion score index, as well as health-related behaviors. GWBS scores were obtained for 210 individuals, with MSIMI present in 92 (43.8%) and ESIMI present in 64 (30.5%). There was a significant inverse correlation between GWBS-PE (Positive Emotion subscale) scores and probability of ESIMI (OR=0.55 (95%CI 0.36-0.83), p=0.005). This association persisted after additional control for CESD subscales measuring negative and positive emotions and for variables reflecting health-related behaviors. A similar inverse correlation between GWBS-PE and MSIMI was observed, but did not reach statistical significance (OR=0.81 (95%CI 0.54-1.20), p=0.28). This is, to our knowledge, the first study demonstrating that greater levels of self-reported positive emotions are associated with a lower likelihood of ESIMI among patients with known IHD. Our results highlight the important interface functions of the central nervous and cardiovascular systems and underscore

Nudging socially isolated people towards well-being with the ‘Happiness Route’: design of a randomized controlled trial for the evaluation of a happiness-based intervention

Science.gov (United States)

2013-01-01

Shortcomings of earlier intervention studies in positive psychology will be tackled with this study, such as having a target group who is especially vulnerable for low well-being. The practice-based setting is especially interesting, as it can give valuable insights in how positive psychology interventions work in practice, but can also give rise to several challenges. Trial registration Dutch Trial Register, trial registration number TC=3377NTR. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3377. PMID:24053566

Discovery of Organophosphate Resistance-Related Genes Associated With Well-known Resistance Mechanisms of Plutella xylostella (L.) (Lepidoptera: Plutellidae) by RNA-Seq.

Science.gov (United States)

Hsu, Ju-Chun; Lin, Yu-Yu; Chang, Chia-Che; Hua, Kuo-Hsun; Chen, Mei-Ju May; Huang, Li-Hsin; Chen, Chien-Yu

2016-04-22

Pesticide resistance poses many challenges for pest control, particularly for destructive pests such as diamondback moths (Plutella xylostella). Organophosphates have been used in the field since the 1950s, leading to selection for resistance-related gene variants and the development of resistance to new insecticides in the diamondback moth. Identifying actual and potential genes involved in resistance could offer solutions for control. This study established resistant diamondback moth strains from two different collections using mevinphos. Two sets of transcriptome sequencing (RNA-Seq) data were generated for pairs of mevinphos-resistant versus susceptible (wild-type) strains. One susceptible strain containing 14 giga base pairs was assembled into a reference-based assembly using published scaffold sequences as reference. Differential expression data between resistant and susceptible strains revealed 944 transcripts (803 with annotations) showing upregulation and 427 transcripts (150 with annotations) showing downregulation. Around 6.8% of the differential expression transcripts (65) could be categorized as associated with well-known resistance mechanisms such as penetration, detoxification, and behavior response; of these 65 transcripts, 38 showed upregulation, and 12 relating to penetration were upregulated when the transcripts of 19 cytochrome P450s, 2 zeta-class glutathione S-transferases, and 4 ATP-binding cassette transporters showed upregulation. In addition, 11 groups of transcripts related to olfactory perception appeared to be downregulated in trade-off situations. Quantitative polymerase chain reaction expression results were consistent with RNA-Seq data. Possible roles of these differentially expressed genes in resistance mechanisms are discussed in this study. © The Authors 2016. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

IgG4-related Hashimoto’s thyroiditis – A new variant of a well known disease

OpenAIRE

Luiz, Henrique Vara; Gonçalves, Diogo; Silva, Tiago Nunes da; Nascimento, Isabel; Ribeiro, Ana; Mafra, Manuela; Manita, Isabel; Portugal, Jorge

2014-01-01

Hashimoto’s thyroiditis (HT) has been characterized for many years as a well-defined clinicopathologic entity, but is now considered a heterogeneous disease. IgG4-related HT is a new subtype characterized by thyroid inflammation rich in IgG4-positive plasma cells and marked fibrosis. It may be part of the systemic IgG4-related disease. We report a case of a 56-year-old Portuguese man who presented with a one-month history of progressive neck swelling and dysphagia. Laboratory testing revealed...

Principles of exploratory data analysis in problem solving: what can we learn from a well-known case?

NARCIS (Netherlands)

de Mast, J.; Kemper, B.P.H.

2009-01-01

Exploratory data analysis (EDA) is sometimes suggested as a hypothesis identification approach. It is often used as such in problem solving and consists of the analysis of observational data, often collected without well-defined hypotheses, with the purpose of finding clues that could inspire ideas

Linked Clinical Trials – The Development of New Clinical Learning Studies in Parkinson’s Disease Using Screening of Multiple Prospective New Treatments

Science.gov (United States)

Brundin, Patrik; Barker, Roger A.; Conn, P. Jeffrey; Dawson, Ted M.; Kieburtz, Karl; Lees, Andrew J.; Schwarzschild, Michael A.; Tanner, Caroline M.; Isaacs, Tom; Duffen, Joy; Matthews, Helen; Wyse, Richard K.H.

2015-01-01

Finding new therapies for Parkinson’s disease (PD) is a slow process. We assembled an international committee of experts to examine drugs potentially suitable for repurposing to modify PD progression. This committee evaluated multiple drugs currently used, or being developed, in other therapeutic areas, as well as considering several natural, non-pharmaceutical compounds. The committee prioritized which of these putative treatments were most suited to move immediately into pilot clinical trials. Aspects considered included known modes of action, safety, blood-brain-barrier penetration, preclinical data in animal models of PD and the possibility to monitor target engagement in the brain. Of the 26 potential interventions, 10 were considered worth moving forward into small, parallel ‘learning’ clinical trials in PD patients. These trials could be funded in a multitude of ways through support from industry, research grants and directed philanthropic donations. The committee-based approach to select the candidate compounds might help rapidly identify new potential PD treatment strategies for use in clinical trials. PMID:24018336

The WHO-5 Well-Being Index

DEFF Research Database (Denmark)

Topp, C W; Østergaard, S D; Soendergaard, S

2015-01-01

BACKGROUND: The 5-item World Health Organization Well-Being Index (WHO-5) is among the most widely used questionnaires assessing subjective psychological well-being. Since its first publication in 1998, the WHO-5 has been translated into more than 30 languages and has been used in research studies...... is very high. CONCLUSIONS: The WHO-5 is a short questionnaire consisting of 5 simple and non-invasive questions, which tap into the subjective well-being of the respondents. The scale has adequate validity both as a screening tool for depression and as an outcome measure in clinical trials and has been...

Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.

Science.gov (United States)

McCowan, Colin; Thomson, Elizabeth; Szmigielski, Cezary A; Kalra, Dipak; Sullivan, Frank M; Prokosch, Hans-Ulrich; Dugas, Martin; Ford, Ian

2015-01-01

The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.

Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR

Directory of Open Access Journals (Sweden)

Colin McCowan

2015-01-01

Full Text Available Background. The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Methods. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. Results. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. Conclusions. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.

Automatic generation of randomized trial sequences for priming experiments.

Science.gov (United States)

Ihrke, Matthias; Behrendt, Jörg

2011-01-01

In most psychological experiments, a randomized presentation of successive displays is crucial for the validity of the results. For some paradigms, this is not a trivial issue because trials are interdependent, e.g., priming paradigms. We present a software that automatically generates optimized trial sequences for (negative-) priming experiments. Our implementation is based on an optimization heuristic known as genetic algorithms that allows for an intuitive interpretation due to its similarity to natural evolution. The program features a graphical user interface that allows the user to generate trial sequences and to interactively improve them. The software is based on freely available software and is released under the GNU General Public License.

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

Science.gov (United States)

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

2015-05-01

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

Peculiar symmetry structure of some known discrete nonautonomous equations

International Nuclear Information System (INIS)

Garifullin, R N; Habibullin, I T; Yamilov, R I

2015-01-01

We study the generalized symmetry structure of three known discrete nonautonomous equations. One of them is the semidiscrete dressing chain of Shabat. Two others are completely discrete equations defined on the square lattice. The first one is a discrete analogue of the dressing chain introduced by Levi and Yamilov. The second one is a nonautonomous generalization of the potential discrete KdV equation or, in other words, the H1 equation of the well-known Adler−Bobenko−Suris list. We demonstrate that these equations have generalized symmetries in both directions if and only if their coefficients, depending on the discrete variables, are periodic. The order of the simplest generalized symmetry in at least one direction depends on the period and may be arbitrarily high. We substantiate this picture by some theorems in the case of small periods. In case of an arbitrarily large period, we show that it is possible to construct two hierarchies of generalized symmetries and conservation laws. The same picture should take place in case of any nonautonomous equation of the Adler−Bobenko−Suris list. (paper)

Altruistic reasoning in adolescent-parent dyads considering participation in a hypothetical sexual health clinical trial for adolescents.

Science.gov (United States)

Chávez, Noé Rubén; Williams, Camille Y; Ipp, Lisa S; Catallozzi, Marina; Rosenthal, Susan L; Breitkopf, Carmen Radecki

2016-04-01

Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent (dyadic) discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other's altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14-17 years of age and 91% of their parents were mothers, a majority (61%) of dyadic discussions included a statement reflecting altruism. Parents responded to adolescents' statements of altruism more frequently than adolescents responded to parents' statements. Responses included: expresses concern, reiterates altruistic reasoning, agrees with altruistic reasoning, and adds to/expands altruistic reasoning. Since an altruistic perspective was often balanced with concerns about risk or study procedures, researchers cannot assume that altruism will directly lead to study participation. Optimizing the informed consent process for early phase clinical trials involving healthy adolescents may include supporting parents to have conversations with their adolescents which will enhance their capacity to consider all aspects of trial participation.

Ongoing EEG phase as a trial-by-trial predictor of perceptual and attentional variability

Directory of Open Access Journals (Sweden)

Rufin eVanRullen

2011-04-01

Full Text Available Even in well-controlled laboratory environments, apparently identical repetitions of an experimental trial can give rise to highly variable perceptual outcomes and behavioral responses. This variability is generally discarded as a reflection of intrinsic noise in neuronal systems. However, part of this variability may be accounted for by trial-by-trial fluctuations of the phase of ongoing oscillations at the moment of stimulus presentation. For example, the phase of an EEG oscillation reflecting the rapid waxing and waning of sustained attention can predict the perception of a subsequent visual stimulus at threshold. Similar ongoing periodicities account for a portion of the trial-by-trial variability of visual reaction times. We review the available experimental evidence linking ongoing EEG phase to perceptual and attentional variability, and the corresponding methodology. We propose future tests of this relation, and discuss the theoretical implications for understanding the neuronal dynamics of sensory perception.

Organisation and management of the first clinical trial of BNCT in Europe (EORTC Protocol 11961)

International Nuclear Information System (INIS)

Sauerwein, W.; Rassow, J.; Hideghety, K.; Sack, H.; Moss, R.; Stecher-Rasmussen, F.; Wolbers, J.G.

1999-01-01

Boron Neutron Capture Therapy is based on the ability of the isotope 10 B to capture thermal neutrons and to disintegrate instantaneously producing high LET particles. The only neutron beam available in Europe for such a treatment is based at the European High Flux Reactor HFR at Petten (The Netherlands). The European Commission, owners of the reactor, decided that the potential benefit of the facility should be opened to all European citizens and therefore insisted on a multinational approach to perform the first clinical trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities actions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, which apart from being conducted in a non-hospital environment, is per se known to be dangerous. It was therefore of the utmost importance that special attention is given to safety, beyond normal rules, and to the training of staff. In itself, the trial is an unusual Phase I study, introducing a new drug with a new irradiation modality, with really an unknown dose-effect relationship. This trial must follow optimal procedures, which underscore the quality and qualified manner of performance. (orig.)

Health status of adults with Short Stature: A comparison with the normal population and one well-known chronic disease (Rheumatoid Arthritis

Directory of Open Access Journals (Sweden)

Naess Eva E

2007-02-01

Full Text Available Abstract Background To examine the subjective health status of adults with short stature (ShSt and compare with the general population (GP and one well-known chronic disease, rheumatoid artritis (RA. In addition, to explore the association between age, gender, height, educational level and different aspects of health status of adults with short stature. Methods A questionnaire was mailed to 72 subjects with short stature registered in the database of a Norwegian resource centre for rare disorders, response rate 61% (n = 44, age 16–61. Health status was assessed with SF-36 version 2. Comparison was done with age and gender matched samples from the general population in Norway (n = 264 and from subjects with RA (n = 88. Results The ShSt sample reported statistically significant impaired health status in all SF-36 subscales compared with the GP sample, most in the physical functioning, Mean Difference (MD 34 (95% Confidence Interval (CI 25–44. The ShSt reported poorer health status in mental health, MD 11 (95% CI 4–18 and social functioning, MD 11 (95% CI 2–20 but better in role physical MD 13 (95% CI 1–25 than the RA sample. On the other subscales there were minor difference between the ShSt and the RA sample. Within the short stature group there was a significant association between age and all SF-36 physical subcales, height was significantly associated with physical functioning while level of education was significantly associated with mental health. Conclusion People with short stature reported impaired health status in all SF-36 subscales indicating that they have health problems that influence their daily living. Health status seems to decline with increasing age, and earlier than in the general population.

The use of ginger (Zingiber officinale) for the treatment of pain: a systematic review of clinical trials.

Science.gov (United States)

Terry, Rohini; Posadzki, Paul; Watson, Leala K; Ernst, Edzard

2011-12-01

  Zingiber officinale (Z. officinale), commonly known as ginger, has been widely used traditionally for a variety of medicinal purposes, one of which is for the treatment of pain. The aim of this systematic review was to evaluate the evidence from all human participant clinical trials that have assessed the efficacy of ginger for the treatment of any type of pain.   Following a protocol, multiple databases were sought using comprehensive search strategies for Z. officinale and pain together with a trial filter for randomized or controlled clinical trials. Trials testing the efficacy of Z. officinale, used as a sole oral treatment against a comparison condition in human adults suffering from any pain condition, were included.   Seven published articles, reporting a total of eight trials (481 participants), were included in the review. Six trials (two for osteoarthritis, one for dysmenorrhea, and three for experimentally induced acute muscle pain) found that the use of Z. officinale reduced subjective pain reports. The methodological quality of the included articles was variable. When assessed using the Jadad scale, which allows a score of between 0 and 5 to be given, included articles obtained Jadad ratings ranging from 2 to 5.   Due to a paucity of well-conducted trials, evidence of the efficacy of Z. officinale to treat pain remains insufficient. However, the available data provide tentative support for the anti-inflammatory role of Z. officinale constituents, which may reduce the subjective experience of pain in some conditions such as osteoarthritis. Further rigorous trials therefore seem to be warranted. Wiley Periodicals, Inc.

The effect of ultrapro or prolene mesh on postoperative pain and well-being following endoscopic Totally Extraperitoneal (TEP hernia repair (TULP: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Schouten Nelleke

2012-06-01

Full Text Available Abstract Background The purpose of this study was to describe the rationale and design of a randomized controlled trial analyzing the effects of mesh type (Ultrapro versus Prolene mesh on postoperative pain and well-being following an endoscopic Totally Extraperitoneal (TEP repair for inguinal hernias (short: TULP trial. Methods and design The TULP trial is a prospective, two arm, double blind, randomized controlled trial to assess chronic postoperative pain and quality of life following implantation of a lightweight (Ultrapro and heavyweight (Prolene mesh in endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specializing in TEP hernia repair. All patients are operated on by one of four surgeons. Adult male patients (≥18 years of age with primary, reducible, unilateral inguinal hernias and no contraindications for TEP repair are eligible for inclusion in the study. The primary outcome is substantial chronic postoperative pain, defined as moderate to severe pain persisting ≥ 3 months postoperatively (Numerical Rating Scale, NRS 4–10. Secondary endpoints are the individual development of pain until three years after the TEP procedure, the quality of life (QoL, recurrence rate, patient satisfaction and complications. Discussion Large prospective randomized controlled studies with a long follow-up evaluating the incidence of chronic postoperative pain following implantation of lightweight and heavyweight mesh in endoscopic (TEP hernia repair are limited. By studying the presence of pain and quality of life, but also complications and recurrences in a large patient population, a complete efficiency and feasibility assessment of both mesh types in TEP hernia repair will be performed. Trial registration The TULP study is registered in the Dutch Trial Register (NTR2131

Digital Cognitive Behavioural Therapy for Insomnia versus sleep hygiene education: the impact of improved sleep on functional health, quality of life and psychological well-being. Study protocol for a randomised controlled trial.

Science.gov (United States)

Espie, Colin A; Luik, Annemarie I; Cape, John; Drake, Christopher L; Siriwardena, A Niroshan; Ong, Jason C; Gordon, Christopher; Bostock, Sophie; Hames, Peter; Nisbet, Mhairi; Sheaves, Bryony; G Foster, Russell; Freeman, Daniel; Costa-Font, Joan; Emsley, Richard; Kyle, Simon D

2016-05-23

Previous research has demonstrated that digital CBT (dCBT), delivered via the Internet, is a scalable and effective intervention for treating insomnia in otherwise healthy adults and leads to significant improvements in primary outcomes relating to sleep. The majority of people with insomnia, however, seek help because of the functional impact and daytime consequences of poor sleep, not because of sleep discontinuity per se. Although some secondary analyses suggest that dCBT may have wider health benefits, no adequately powered study has investigated these as a primary endpoint. This study specifically aims to investigate the impact of dCBT for insomnia upon health and well-being, and will investigate sleep-related changes as mediating factors. We propose a pragmatic, parallel-group, randomised controlled trial of 1000 community participants meeting criteria for insomnia disorder. In the DIALS trial (Digital Insomnia therapy to Assist your Life as well as your Sleep), participants will be randomised to dCBT delivered using web and/or mobile channels (in addition to treatment as usual (TAU)) or to sleep hygiene education (SHE), comprising a website plus a downloadable booklet (in addition to TAU). Online assessments will take place at 0 (baseline), 4 (mid-treatment), 8 (post-treatment), and 24 (follow-up) weeks. At week 25 all participants allocated to SHE will be offered dCBT, at which point the controlled element of the trial will be complete. Naturalistic follow-up will be invited at weeks 36 and 48. Primary outcomes are functional health and well-being at 8 weeks. Secondary outcomes are mood, fatigue, sleepiness, cognitive function, productivity and social functioning. All main analyses will be carried out at the end of the final controlled follow-up assessments and will be based on the intention-to-treat principle. Further analyses will determine whether observed changes in functional health and well-being are mediated by changes in sleep. The trial is funded

Preventing knee injuries in adolescent female football players – design of a cluster randomized controlled trial [NCT00894595

Directory of Open Access Journals (Sweden)

Waldén Markus

2009-06-01

Full Text Available Abstract Background Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. Methods In this cluster randomized trial 516 teams (309 clusters in eight regional football districts in Sweden with female players aged 13–17 years were randomized into an intervention group (260 teams or a control group (256 teams. The teams in the intervention group were instructed to do a structured warm-up program at two training sessions per week throughout the 2009 competitive season (April to October and those in the control group were informed to train and play as usual. Sixty-eight sports physical therapists are assigned to the clubs to assist both groups in data collection and to examine the players' acute knee injuries during the study period. Three different forms are used in the trial: (1 baseline player data form collected at the start of the trial, (2 computer-based registration form collected every month, on which one of the coaches/team leaders documents individual player exposure, and (3 injury report form on which the study therapists report acute knee injuries resulting in time loss from training or match play. The primary outcome is the incidence of ACL injury and the secondary outcomes are the incidence of any acute knee injury (except contusion and incidence of severe knee injury (defined as injury resulting in absence of more than 4 weeks. Outcome measures are assessed after the end of the 2009 season. Discussion Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to

Blockade of muscarinic receptors impairs the retrieval of well-trained memory

Directory of Open Access Journals (Sweden)

Shogo eSoma

2014-04-01

Full Text Available Acetylcholine (ACh is known to play an important role in memory functions, and its deficit has been proposed to cause the cognitive decline associated with advanced age and Alzheimer’s disease (the cholinergic hypothesis. Although many studies have tested the cholinergic hypothesis for recently acquired memory, only a few have investigated the role of ACh in the retrieval process of well-trained cognitive memory, which describes the memory established from repetition and daily routine. To examine this point, we trained rats to perform a two-alternative forced-choice visual detection task. Each trial was started by having the rats pull upward a central-lever, which triggered the presentation of a visual stimulus to the right or left side of the display monitor, and then pulling upward a stimulus-relevant choice-lever located on both sides. Rats learned the task within 10 days, and the task training was continued for a month. Task performance was measured with or without systemic administration of a muscarinic ACh receptor (mAChR antagonist, scopolamine (SCOP, prior to the test. After 30 min of SCOP administration, rats stopped manipulating any lever even though they explored the lever and surrounding environment, suggesting a loss of the task-related associative memory. Three hours later, rats were recovered to complete the trial, but the rats selected the levers irrespective of the visual stimulus, suggesting they remembered a series of lever-manipulations in association with a reward, but not association between the reward and visual stimulation. Furthermore, an m1-AChR, but not nicotinic AChR antagonist caused a similar deficit in the task execution. SCOP neither interfered with locomotor activity nor drinking behavior, while it influenced anxiety. These results suggest that the activation of mAChRs at basal ACh levels is essential for the recall of well-trained cognitive memory.

An interim analysis of recruitment to the COLOFOL trial

DEFF Research Database (Denmark)

Wille-Jørgensen, Peer; Laurberg, S.; Pahlman, L.

2009-01-01

Objective To analyse the ongoing process of recruiting patients into a multicenter randomized trial on follow-up after curative surgery for colorectal cancer. The trial is registered in Clinical Trials Registration. Method Prospective registration of all operated patients as well as inclusions...

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

Science.gov (United States)

REICHMAN, JEROME H.

2009-01-01

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

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

Science.gov (United States)

Reichman, Jerome H

2009-01-01

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

Cryo-thawed embryo transfer: natural versus artificial cycle. A non-inferiority trial.(ANTARCTICA trial

Directory of Open Access Journals (Sweden)

Groenewoud Eva R

2012-09-01

Full Text Available Abstract Background Frozen thawed embryo transfer (FET is a cost- effective adjunct to IVF or IVF-ICSI treatment. In order to optimize treatment outcome, FET should be carried out during a period of optimal endometrial receptivity. To optimize implantation several methods for endometrium preparation have been proposed. In natural cycle FET (NC-FET, the endometrium develops under endogenous hormonal stimulation. The development of the dominant follicle and endometrium is monitored by ultrasound and FET is timed after triggering ovulation induction or determination of the spontaneous LH surge. In an artificial cycle FET (AC-FET estrogens and progesterone are administered to prepare the endometrium for implantation. While the currently available data show no significant difference in pregnancy rates between these methods, well designed randomized controlled trials are lacking. Moreover there is little literature on difference in cancellation rates, cost-efficiency and adverse events. Methods and design In this randomized, multi-centre, non-inferiority trial we aim to test the hypothesis that there is no significant difference in live birth rates between patients undergoing NC-FET versus AC-FET. The primary outcome will be live birth rate per embryo transfer procedure. Secondary outcomes will be ongoing and clinical pregnancy rate, cancellation rate, (serious adverse events and cost-efficiency. Based on a live birth rate of 20% and a minimal clinical important difference of 7,5% (one-sided alpha 2,5%, beta 20% a total of 1150 patients will be needed. Analyzes will be performed using both per protocol as well as intention to treat analyses. Discussion This prospective, randomized, non –inferiority trial aims to address the hypothesis that there is no significant difference in live birth rates between patients undergoing NC-FET versus patients undergoing AC-FET. Moreover it addresses cost-efficiency as well as the perceived burden of both treatments

Primary prevention of stroke and cardiovascular disease in the community (PREVENTS): Methodology of a health wellness coaching intervention to reduce stroke and cardiovascular disease risk, a randomized clinical trial.

Science.gov (United States)

Mahon, Susan; Krishnamurthi, Rita; Vandal, Alain; Witt, Emma; Barker-Collo, Suzanne; Parmar, Priya; Theadom, Alice; Barber, Alan; Arroll, Bruce; Rush, Elaine; Elder, Hinemoa; Dyer, Jesse; Feigin, Valery

2018-02-01

Rationale Stroke is a major cause of death and disability worldwide, yet 80% of strokes can be prevented through modifications of risk factors and lifestyle and by medication. While management strategies for primary stroke prevention in high cardiovascular disease risk individuals are well established, they are underutilized and existing practice of primary stroke prevention are inadequate. Behavioral interventions are emerging as highly promising strategies to improve cardiovascular disease risk factor management. Health Wellness Coaching is an innovative, patient-focused and cost-effective, multidimensional psychological intervention designed to motivate participants to adhere to recommended medication and lifestyle changes and has been shown to improve health and enhance well-being. Aims and/or hypothesis To determine the effectiveness of Health Wellness Coaching for primary stroke prevention in an ethnically diverse sample including Māori, Pacific Island, New Zealand European and Asian participants. Design A parallel, prospective, randomized, open-treatment, single-blinded end-point trial. Participants include 320 adults with absolute five-year cardiovascular disease risk ≥ 10%, calculated using the PREDICT web-based clinical tool. Randomization will be to Health Wellness Coaching or usual care groups. Participants randomized to Health Wellness Coaching will receive 15 coaching sessions over nine months. Study outcomes A substantial relative risk reduction of five-year cardiovascular disease risk at nine months post-randomization, which is defined as 10% relative risk reduction among those at moderate five-year cardiovascular disease risk (10-15%) and 25% among those at high risk (>15%). Discussion This clinical trial will determine whether Health Wellness Coaching is an effective intervention for reducing modifiable risk factors, and hence decrease the risk of stroke and cardiovascular disease.

Participants? perspectives on mindfulness-based cognitive therapy for inflammatory bowel disease: a qualitative study nested within a pilot randomised controlled trial

OpenAIRE

Schoultz, Mariyana; Macaden, Leah; Hubbard, Gill

2016-01-01

Background Mindfulness-based interventions have shown to improve depression and anxiety symptoms as well as quality of life in patients with inflammatory bowel disease (IBD). However, little is known about the experiences of this group of patients participating in mindfulness interventions. This paper sets out to explore the perspectives of patients with IBD recruited to a pilot randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) about the intervention. Methods In ...

Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer.

Science.gov (United States)

Reeves, Marina M; Terranova, Caroline O; Erickson, Jane M; Job, Jennifer R; Brookes, Denise S K; McCarthy, Nicole; Hickman, Ingrid J; Lawler, Sheleigh P; Fjeldsoe, Brianna S; Healy, Genevieve N; Winkler, Elisabeth A H; Janda, Monika; Veerman, J Lennert; Ware, Robert S; Prins, Johannes B; Vos, Theo; Demark-Wahnefried, Wendy; Eakin, Elizabeth G

2016-10-28

Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness. Women (18-75 years; body mass index 25-45 kg/m 2 ) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of

Efficacy of S-flurbiprofen plaster in knee osteoarthritis treatment: Results from a phase III, randomized, active-controlled, adequate, and well-controlled trial.

Science.gov (United States)

Yataba, Ikuko; Otsuka, Noboru; Matsushita, Isao; Matsumoto, Hideo; Hoshino, Yuichi

2017-01-01

S-flurbiprofen plaster (SFPP) is a novel non-steroidal anti-inflammatory drug (NSAID) patch, intended for topical treatment for musculoskeletal diseases. This trial was conducted to examine the effectiveness of SFPP using active comparator, flurbiprofen (FP) patch, on knee osteoarthritis (OA) symptoms. This was a phase III, multi-center, randomized, adequate, and well-controlled trial, both investigators and patients were blinded to the assigned treatment. Enrolled 633 knee OA patients were treated with either SFPP or FP patch for two weeks. The primary endpoint was improvement in knee pain on rising from the chair as assessed by visual analogue scale (rVAS). Safety was evaluated through adverse events (AEs). The change in rVAS was 40.9 mm in SFPP group and 30.6 mm in FP patch group (p < 0.001). The incidence of drug-related AEs at the application site was 9.5% (32 AEs, 29 mild and 3 moderate) in SFPP and 1.6% in FP patch (p < 0.001). Withdrawals due to AE were five in SFPP and one in FP patch. The superiority of SFPP in efficacy was demonstrated. Most of AEs were mild and few AEs led to treatment discontinuation. Therefore, SFPP provides an additional option for knee OA therapy.

Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial.

Science.gov (United States)

Schnelle, Christoph; Messerschmidt, Steffen; Minford, Eunice J; Greenaway-Twist, Kate; Szramka, Maxine; Masiorski, Marianna; Sheldrake, Michelle; Jones, Mark

2017-07-17

Low back pain causes more global disability than any other condition. Once the acute pain becomes chronic, about two-thirds of sufferers will not fully recover after 1-2 years. There is a paucity of effective treatments for non-specific, chronic low back pain. It has been noted that low back pain is associated with changes in the connective tissue in the affected area, and a very low-impact treatment, Esoteric Connective Tissue Therapy (ECTT), has been developed to restore flexibility in connective tissue. ECTT uses patterns of very small, circular movements, to the legs, arms, spine, sacrum and head, which anecdotally are effective in pain relief. In an unpublished single-arm phase I/II trial with chronic pain patients, ECTT showed a 56% reduction in pain after five treatments and 45% and 54% improvements at 6 months and 7-9 years of follow-up respectively. The aim of this randomised controlled trial is to compare ECTT with physiotherapy for reducing pain and improving physical function and physical and mental well-being in patients with chronic low back pain. The trial will be held at two hospitals in Vietnam. One hundred participants with chronic low back pain greater than or equal to 40/100 on the visual analogue scale will be recruited and randomised to either ECTT or physiotherapy. Four weekly treatments will be provided by two experienced ECTT practitioners (Treatment Group, 40 minutes each) and hospital-employed physiotherapy nurses (Control Group, 50 minutes). The primary outcomes will be changes in pain, physical function per the Quebec Pain Functionality Questionnaire and physical and mental well-being recorded by the Short Form Health Survey (SF-36), with mixed modelling used as the primary statistical tool because the data are longitudinal. Initial follow-up will be at either 4 or 8 months, with a second follow-up after 12 months. The trial design has important strengths, because it is to be conducted in hospitals under medical supervision

Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India

Directory of Open Access Journals (Sweden)

Mansi Chaturvedi

2017-01-01

Full Text Available Background: India continues to contribute disproportionately to the global burden of disease and public health research output from India is also known to be not commensurate with her healthcare needs. We carried out the present study to assess if clinical trials were in line with the health care needs of the country by auditing the clinical trials registry of India. Materials and Methods: All the clinical studies registered in CTRI between July 20, 2007 and December 31, 2015 were searched in the “Trial Search” section. The total number of studies, their phases of development, and therapeutic areas were assessed. Trials in each therapeutic area was compared with the disease burden (DALYs in that area taken from Global Health Estimates [2014] Summary Tables of the WHO. The number of trials conducted per state in India was also compared with the population of that state [Census 2011]. Results: A total of 6474 studies were registered of which 3325 (51.4% were clinical trials. The state of Maharashtra had the highest number trials [16.4%] followed by Karnataka ( 11.6% and Tamil Nadu (10%. Populous states like Uttar Pradesh (5.3% and Bihar (1.4% had far fewer trials. The largest number of trials was in the area of cancer (16.4%, followed by diabetes (12.1% and cardiovascular diseases (10.1%. Infectious and parasitic diseases had the highest DALYs (82,681 and ranked first in disease burden but accounted for only 5% of the total trials and ranked 7th according to number of trials. Cancer ranked first in the number of trials (16.4%, but ranked 6th based on DALYs. Conclusion: Clinical trials conducted in India are not in consonance with her health care needs. Strengthening the capacity for conducting trials in the populous states and the north-eastern part of the country is necessary to allow a more equitable selection of participants. The government should introduce policies to encourage new drug development in areas where needed the most.

Publication status of contemporary oncology randomised controlled trials worldwide.

Science.gov (United States)

Chen, Yu-Pei; Liu, Xu; Lv, Jia-Wei; Li, Wen-Fei; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

2016-10-01

Little is known about the extent of selective publication in contemporary oncology randomised controlled trials (RCTs) worldwide. This study aimed to evaluate the rates of publication and timely publication (within 24 months) for contemporary oncology RCTs from all over the world. We also investigated the trial characteristics associated with publication and timely publication. We identified all phase III oncology RCTs registered on ClinicalTrials.gov with a primary completion date between January 2008 and December 2012. We searched PubMed and EMBASE to identify publications. The final search date was 31 December 2015. Our primary outcome measure was the time to publication from the primary completion date to the date of primary publication in a peer-reviewed journal. We identified 598 completed oncology RCTs; overall, 398 (66.6%) had been published. For published trials, the median time to publication was 25 months (interquartile range, 16-37 months). Only 192 trials (32.1%) were published within 24 months. Timely publication was independently associated with trials completed late in 2012. Trials conducted in Asia and other regions were less likely to have timely publication, but trials conducted in different locations were all equally likely to be published. Industry- and NIH-funded trials were equally likely to be published timely or at any time after trial completion. Among 391 published trials with clear primary outcomes, there was a trend for timely publication of positive trials compared with negative trials. Despite the ethical obligations and societal expectations of disclosing findings promptly, oncology RCTs performed poorly. Copyright © 2016 Elsevier Ltd. All rights reserved.

Forecasting method for global radiation time series without training phase: Comparison with other well-known prediction methodologies

International Nuclear Information System (INIS)

Voyant, Cyril; Motte, Fabrice; Fouilloy, Alexis; Notton, Gilles; Paoli, Christophe; Nivet, Marie-Laure

2017-01-01

Integration of unpredictable renewable energy sources into electrical networks intensifies the complexity of the grid management due to their intermittent and unforeseeable nature. Because of the strong increase of solar power generation the prediction of solar yields becomes more and more important. Electrical operators need an estimation of the future production. For nowcasting and short term forecasting, the usual technics based on machine learning need large historical data sets of good quality during the training phase of predictors. However data are not always available and induce an advanced maintenance of meteorological stations, making the method inapplicable for poor instrumented or isolated sites. In this work, we propose intuitive methodologies based on the Kalman filter use (also known as linear quadratic estimation), able to predict a global radiation time series without the need of historical data. The accuracy of these methods is compared to other classical data driven methods, for different horizons of prediction and time steps. The proposed approach shows interesting capabilities allowing to improve quasi-systematically the prediction. For one to 10 h horizons Kalman model performances are competitive in comparison to more sophisticated models such as ANN which require both consistent historical data sets and computational resources. - Highlights: • Solar radiation forecasting with time series formalism. • Trainless approach compared to machine learning methods. • Very simple method dedicated to solar irradiation forecasting with high accuracy.

Update on clinical trials in Dysphagia.

Science.gov (United States)

Logemann, Jeri A

2006-04-01

Randomized clinical trials (RCTs) are often known as the gold standard in treatment efficacy studies. This article defines the characteristics of RCTs and the factors that investigators must consider in designing clinical trials in dysphagia. Design issues unique to behavioral treatments often used in dysphagia are discussed. Ongoing RCTs in dysphagia are described including studies of (1) the effectiveness of the Shaker exercise versus standardized treatment in patients with severe dysphagia resulting from stroke or treatment for head and neck cancer who have been nonoral for at least three months; (2) the comparative effects of nectar- and honey-thickened liquids versus chin tuck posture and in patients with dementia or Parkinson's disease with or without dementia who aspirate on thin liquids; and (3) the comparative effects of muscle exercise versus sensory postural therapy for dysphagia resulting from treatment for head and neck cancer. Issues in generalizing from the results of clinical trials are also described.

Neuronal Substrates Underlying Performance Variability in Well-Trained Skillful Motor Task in Humans.

Science.gov (United States)

Mizuguchi, Nobuaki; Uehara, Shintaro; Hirose, Satoshi; Yamamoto, Shinji; Naito, Eiichi

2016-01-01

Motor performance fluctuates trial by trial even in a well-trained motor skill. Here we show neural substrates underlying such behavioral fluctuation in humans. We first scanned brain activity with functional magnetic resonance imaging while healthy participants repeatedly performed a 10 s skillful sequential finger-tapping task. Before starting the experiment, the participants had completed intensive training. We evaluated task performance per trial (number of correct sequences in 10 s) and depicted brain regions where the activity changes in association with the fluctuation of the task performance across trials. We found that the activity in a broader range of frontoparietocerebellar network, including the bilateral dorsolateral prefrontal cortex (DLPFC), anterior cingulate and anterior insular cortices, and left cerebellar hemisphere, was negatively correlated with the task performance. We further showed in another transcranial direct current stimulation (tDCS) experiment that task performance deteriorated, when we applied anodal tDCS to the right DLPFC. These results indicate that fluctuation of brain activity in the nonmotor frontoparietocerebellar network may underlie trial-by-trial performance variability even in a well-trained motor skill, and its neuromodulation with tDCS may affect the task performance.

Goal-setting to Promote a Healthier Lifestyle in Later Life: Qualitative Evaluation of the AgeWell Trial.

Science.gov (United States)

Nelis, Sharon M; Thom, Jeanette M; Jones, Ian Rees; Hindle, John V; Clare, Linda

2017-12-15

We report a mixed method evaluation of the feasibility and implementation of the AgeWell goal-setting intervention to promote healthy ageing later life. Researcher field notes, goal-setting interview content, and semi-structured interviews with participants were content analysed to review trial implementation and participants' perspective on the goal-setting and mentoring intervention. 75 people were recruited: 21 in the goal-setting and 22 in the goal-setting with mentoring arms of the intervention. Goal-setting was feasible in the main domains of interest. Adherence to the protocol was good and the mentoring schedule was adhered to. Participants reported satisfaction with their goal attainment, but barriers for non-achievement were also identified. Recommendations for small changes to the intervention included reducing the number of goals. Participants understood the goal-setting process, and were able to set realistic and achievable lifestyle goals. The intervention and the procedures were acceptable but changes in how goal-setting is both introduced and monitored are needed for wider implementation. Goal-setting can be a useful process to help people alter their lifestyle to allow them to age more successfully and reduce risk factors associated with dementia.

Bruneau Known Geothermal Resource Area: an environmental analysis

Energy Technology Data Exchange (ETDEWEB)

Spencer, S.G.; Russell, B.F. (eds.)

1979-09-01

The Bruneau Known Geothermal Resource Area (KGRA) is part of the Bruneau-Grandview thermal anomaly, the largest geothermal area in the western US. This part of Owyhee County is the driest part of Idaho. The KGRA is associated with the southern boundary fault zone of the Snake River Plain. Thermal water, produced from numerous artesian wells in the region, is supplied from two major aquifers. Ecological concerns include the threatened Astragalus mulfordiae and the numerous birds of prey nesting in the Snake River canyon northwest of the KGRA. Extensive geothermal development may strain the limited health care facilities in the county. Ethnographic information suggests that there is a high probability of prehistoric cultural materials being remnant in the Hot Spring locality.

Clinical trial quality: From supervision to collaboration and beyond.

Science.gov (United States)

Meeker-O'Connell, Ann; Glessner, Coleen

2018-02-01

Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

Clustered randomised controlled trial of two education interventions designed to increase physical activity and well-being of secondary school students: the MOVE Project.

Science.gov (United States)

Tymms, Peter B; Curtis, Sarah E; Routen, Ash C; Thomson, Katie H; Bolden, David S; Bock, Susan; Dunn, Christine E; Cooper, Ashley R; Elliott, Julian G; Moore, Helen J; Summerbell, Carolyn D; Tiffin, Paul A; Kasim, Adetayo S

2016-01-06

To assess the effectiveness of 2 interventions in improving the physical activity and well-being of secondary school children. A clustered randomised controlled trial; classes, 1 per school, were assigned to 1 of 3 intervention arms or a control group based on a 2×2 factorial design. The interventions were peer-mentoring and participative learning. Year 7 children (aged 11-12) in the peer-mentoring intervention were paired with year 9 children for 6 weekly mentoring meetings. Year 7 children in the participative learning arm took part in 6 weekly geography lessons using personalised physical activity and Global Positioning System (GPS) data. Year 7 children in the combined intervention received both interventions, with the year 9 children only participating in the mentoring sessions. 1494 year 7 students from 60 schools in the North of England took part in the trial. Of these, 43 students opted out of taking part in the evaluation measurements, 2 moved teaching group and 58 changed school. Valid accelerometry outcome data were collected for 892 students from 53 schools; and well-being outcome data were available for 927 students from 52 schools. The primary outcomes were mean minutes of accelerometer-measured moderate-to-vigorous intensity physical activity per day, and well-being as evaluated by the KIDSCREEN-27 questionnaire. These data were collected 6 weeks after the intervention; a 12-month follow-up is planned. No significant effects (main or interaction) were observed for the outcomes. However, small positive differences were found for both outcomes for the participative learning intervention. These findings suggest that the 2 school-based interventions did not modify levels of physical activity or well-being within the period monitored. Change in physical activity may require more comprehensive individual behavioural intervention, and/or more system-based efforts to address wider environmental influences such as family, peers, physical environment

The synthesis, regulation, and functions of sterols in Candida albicans: Well-known but still lots to learn.

Science.gov (United States)

Lv, Quan-Zhen; Yan, Lan; Jiang, Yuan-Ying

2016-08-17

Sterols are the basal components of the membranes of the fungal pathogen Candida albicans, and these membranes determine the susceptibility of C. albicans cells to a variety of stresses, such as ionic, osmotic and oxidative pressures, and treatment with antifungal drugs. The common antifungal azoles in clinical use are targeted to the biosynthesis of ergosterol. In the past years, the synthesis, storage and metabolism of ergosterol in Saccharomyces cerevisiae has been characterized in some detail; however, these processes has not been as well investigated in the human opportunistic pathogen C. albicans. In this review, we summarize the genes involved in ergosterol synthesis and regulation in C. albicans. As well, genes in S. cerevisiae implicated in ergosterol storage and conversions with other lipids are noted, as these provide us clues and directions for the study of the homologous genes in C. albicans. In this report we have particularly focused on the essential roles of ergosterol in the dynamic process of cell biology and its fundamental status in the biological membrane system that includes lipid rafts, lipid droplets, vacuoles and mitochondria. We believe that a thorough understanding of this classic and essential pathway will give us new ideas about drug resistance and morphological switching in C. albicans.

Does participating in a clinical trial affect subsequent nursing management? Post-trial care for participants recruited to the INTACT pressure ulcer prevention trial: A follow-up study.

Science.gov (United States)

Webster, Joan; Bucknall, Tracey; Wallis, Marianne; McInnes, Elizabeth; Roberts, Shelley; Chaboyer, Wendy

2017-06-01

Participation in a clinical trial is believed to benefit patients but little is known about the post-trial effects on routine hospital-based care. To describe (1) hospital-based, pressure ulcer care-processes after patients were discharged from a pressure ulcer prevention, cluster randomised controlled trial; and (2) to investigate if the trial intervention had any impact on subsequent hospital-based care. We conducted a retrospective analysis of 133 trial participants who developed a pressure ulcer during the clinical trial. We compared outcomes and care processes between participants who received the pressure ulcer prevention intervention and those in the usual care, control group. We also compared care processes according to the pressure ulcer stage. A repositioning schedule was reported for 19 (14.3%) patients; 33 (24.8%) had a dressing applied to the pressure ulcer; 17 (12.8) patients were assessed by a wound care team; and 20 (15.0%) were seen by an occupational therapist. Patients in the trial's intervention group were more likely to have the presence of a pressure ulcer documented in their chart (odds ratio (OR) 8.18, 95% confidence intervals (CI) 3.64-18.36); to be referred to an occupational therapist OR 0.92 (95% CI 0.07; 0.54); to receive a pressure relieving device OR 0.31 (95% CI 0.14; 0.69); or a pressure relieving mattress OR 0.44 (95% CI 0.20; 0.96). Participants with Stage 2 or unstageable ulcers were more likely than others to have dressings applied to their wounds (p=pressure ulcer status and care is poor. Copyright © 2017 Elsevier Ltd. All rights reserved.

The effects of office ergonomic training on musculoskeletal complaints, sickness absence, and psychological well-being: a cluster randomized control trial.

Science.gov (United States)

Mahmud, Norashikin; Kenny, Dianna T; Md Zein, Raemy; Hassan, Siti Nurani

2015-03-01

This study explored whether musculoskeletal complaints can be reduced by the provision of ergonomics education. A cluster randomized controlled trial study was conducted in which 3 units were randomized to intervention and received training and 3 units were given a leaflet. The effect of intervention on knowledge, workstation practices, musculoskeletal complaints, sickness absence, and psychological well-being were assessed at 6 and 12 months. Although there was no increment of knowledge among workers, significant improvements in workstation practices in the use of monitor, keyboard, and chair were observed. There were significant reductions in neck and upper and lower back complaints among workers but these did not translate into fewer days lost from work. Workers' stress was found to be significantly reduced across the studies. In conclusion, office ergonomics training can be beneficial in reducing musculoskeletal risks and stress among workers. © 2011 APJPH.

Optimal use of MRI in clinical trials, clinical care and clinical registries of patients with rheumatoid arthritis

DEFF Research Database (Denmark)

Østergaard, Mikkel; Møller-Bisgaard, Signe

2014-01-01

the benefits of including MRI in treat-to-target strategies. The benefits of incorporating MRI into clinical registries are not yet known, but may include improved knowledge about the real-life advantages of MRI, as well as opportunities to develop better clinical and laboratory composite measures to monitor......Magnetic resonance imaging (MRI) clearly is more sensitive than clinical examination and conventional radiography (x-ray) for detection of inflammation (synovitis, bone marrow oedema (osteitis) and tenosynovitis) and damage (bone erosion and cartilage loss/joint space narrowing) in patients...... with rheumatoid arthritis (RA). The question is when and how MRI should be used. The present article reviews our knowledge about, and provides suggestions for, the use of MRI in clinical trials, clinical care and clinical registries. In clinical trials, the OMERACT RA MRI scoring system (RAMRIS) is a thoroughly...

Complying with the European Clinical Trials directive while surviving the administrative pressure

DEFF Research Database (Denmark)

Frandsen, Thomas Leth; Heyman, Mats; Abrahamsson, Jonas

2014-01-01

The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity......-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration...

Current knowledge on alleviating Helicobacter pylori infections through the use of some commonly known natural products: bench to bedside

Directory of Open Access Journals (Sweden)

Malliga Raman Murali

2014-09-01

Full Text Available Helicobacter pylori, a spiral-shaped Gram-negative bacterium, has been classified as a class I carcinogen by the World Health Organization and recognized as the causative agent for peptic ulcers, duodenal ulcer, gastritis, mucosa-associated lymphoid tissue lymphomas, and gastric cancer. Owing to their alarming rate of drug resistance, eradication of H. pylori remains a global challenge. Triple therapy consisting of a proton pump inhibitor, clarithromycin, and either amoxicillin or metronidazole, is generally the recommended standard for the treatment of H. pylori infection. Complementary and alternative medicines have a long history in the treatment of gastrointestinal ailments and various compounds has been tested for anti-H. pylori activity both in vitro and in vivo; however, their successful use in human clinical trials is sporadic. Hence, the aim of this review is to analyze the role of some well-known natural products that have been tested in clinical trials in preventing, altering, or treating H. pylori infections. Whereas some in vitro and in vivo studies in the literature have demonstrated the successful use of a few potential natural products for the treatment of H. pylori-related infections, others indicate a need to consider natural products, with or without triple therapy, as a useful alternative in treating H. pylori-related infections. Thus, the reported mechanisms include killing of H. pylori urease inhibition, induction of bacterial cell damage, and immunomodulatory effect on the host immune system. Furthermore, both in vitro and in vivo studies have demonstrated the successful use of some potential natural products for the treatment of H. pylori-related infections. Nevertheless, the routine prescription of potential complementary and alternative medicines continues to be restrained, and evidence on the safety and efficacy of the active compounds remains a subject of ongoing debate.

Clinical trials. A pending subject.

Science.gov (United States)

Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

2018-04-01

Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Impact of the Alexander technique on well-being: a randomised controlled trial involving older adults with visual impairment.

Science.gov (United States)

Gleeson, Michael; Sherrington, Catherine; Lo, Serigne; Auld, Robin; Keay, Lisa

2017-11-01

Older adults with visual loss have high rates of depression, restricted participation and reduced quality of life. We sought to measure the impact of lessons in the Alexander technique on vision-related emotional and social well-being, as secondary outcomes to a study on improving physical functioning in this population. This is a single-blind randomised controlled trial. One hundred and twenty community-dwelling adults aged 50 to 90 years with visual impairments were randomised to either 12 Alexander lessons over 12 weeks and usual care or usual care. The Perceived Visual Ability Scale, the Keele Assessment of Participation, the emotional subscale of the Impact of Vision Impairment Profile, the Positive and Negative Affect Scale and the five-item Geriatric Depression Scale were administered at baseline and three and 12 months. Participants were receiving services from Guide Dogs NSW/ACT. None of the validated questionnaires found statistically significant improvements after adjustment for baseline at three or 12 months, although the emotional subscale of the Impact of Vision Impairment approached significance in favour of the intervention group (4.54 points, 95 per cent CI: -0.14 to 9.21, p = 0.06). Depressive symptoms were prevalent and associated with greater impact of visual impairment on emotional well-being (odds ratio: 1.12, 95 per cent CI: 1.07 to 1.17, p visual impairment showed a trend toward less distress in the intervention group. Our data found that emotional distress associated with visual impairment influences depressive symptoms but contrary to expectations, the level of social support received was not significant. Additionally, gait speed is a significant predictor of depressive symptoms, suggesting that general mobility is of importance to the well-being of older adults with visual impairments. © 2017 Optometry Australia.

Known Unknowns in Judgment and Choice

OpenAIRE

Walters, Daniel

2017-01-01

This dissertation investigates how people make inferences about missing information. Whereas most prior literature focuses on how people process known information, I show that the extent to which people make inferences about missing information impacts judgments and choices. Specifically, I investigate how (1) awareness of known unknowns affects overconfidence in judgment in Chapter 1, (2) beliefs about the knowability of unknowns impacts investment strategies in Chapter 2, and (3) inferences...

Influence of trial design, heterogeneity and regulatory environment on the results of clinical trials: An appraisal in the context of recent trials on acute stroke intervention

Directory of Open Access Journals (Sweden)

P R Srijithesh

2014-01-01

Full Text Available The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.

75 FR 2921 - In the Matter of the Designation of Said Ali al-Shihri, Also Known as Abu-Sayyaf, Also Known as...

Science.gov (United States)

2010-01-19

... DEPARTMENT OF STATE [Public Notice 6872] In the Matter of the Designation of Said Ali al-Shihri... Known as Abu Sufian Kadhdhaab Matrook, Also Known as Sa'id Ali Jabir al-Khathim al-Shihri, Also Known as... January 23, 2003, I hereby determine that the individual known as Said Ali al- Shihri, and also known as...

Lead editorial: Trials – using the opportunities of electronic publishing to improve the reporting of randomised trials

Directory of Open Access Journals (Sweden)

Grimshaw Jeremy M

2006-03-01

Full Text Available Abstract This editorial introduces the new online, open access, peer-reviewed journal Trials. The journal considers manuscripts on any aspect of the design, performance, and findings of randomised controlled trials in any discipline related to health care, and also encourages the publication of protocols. Trialists will be able to provide the necessary detail for a true and complete scientific record. They will be able to communicate not only all outcome measures, as well as varying analyses and interpretations, but also in-depth descriptions of what they did and honest reflections about what they learnt. Trials also encourages articles covering generic issues related to trials, for example focussing on the design, conduct, analysis, interpretation, or reporting.

Randomized controlled trial of caregiver training for HIV-infected child neurodevelopment and caregiver well being.

Science.gov (United States)

Bass, Judith K; Opoka, Robert; Familiar, Itziar; Nakasujja, Noeline; Sikorskii, Alla; Awadu, Jorem; Givon, Deborah; Shohet, Cilly; Murray, Sarah M; Augustinavicius, Jura; Mendelson, Tamar; Boivin, Michael

2017-08-24

HIV infection places children at neurodevelopmental risk; for young children in poverty, risk is compounded by compromised caregiving quality. The mediational intervention for sensitizing caregivers (MISC) program trained caregivers on fostering daily interactions with young children. We hypothesized that MISC could enhance neurodevelopment of rural Ugandan HIV-infected children and improve mental health outcomes of their caregivers, which might mediate improved caregiving quality. A randomized trial of HIV-infected young children (ages 2-5 years) and their female caregivers; cluster randomization was to MISC or a nutrition curriculum. A total of 18 geographic clusters in rural Uganda. Children and caregivers were evaluated at baseline, 6 months, 1 year, and 1-year post-training. Mullen Scales of Early Learning, the Color-Object Association Test for memory, the Early Childhood Vigilance Test of attention, and the Behavior Rating Inventory of Executive Function for the children. Caregivers completed measures of depression and anxiety symptoms and daily functioning. MISC had a significant impact on postintervention receptive language (adjusted mean difference = 3.13, 95% confidence interval 0.08, 6.18) that persisted at 1-year follow-up. MISC caregivers reported significantly less functional impairment postprogram (adjusted mean difference = -0.15, 95% confidence interval -0.28, -0.01). Other outcomes were NS. Both intervention conditions resulted in improvements in the study children over time. MISC showed additional impacts on child language and caregiver well-being. Future directions that include assessing the extent enhanced language development resulting from improved caregiving may better prepare impoverished children for school.

Cancer clinical trials in persons with HIV infection.

Science.gov (United States)

Little, Richard F

2017-01-01

The era of modern HIV therapeutics is well underway. The cancer and infectious disease epidemiology of HIV disease has markedly altered as populations are availed to the benefits of antiretroviral therapy (ARV). The types of cancers occurring among those with HIV infection has broadened but the case burden in absolute numbers is very low relative to the background population. There are fewer incident cases of the AIDS-defining cancers (aggressive B-cell lymphomas, Kaposi's sarcoma, and cervical cancer). There is an increased risk for certain non-AIDS-defining cancers, but these occur somewhat sporadically relative to clinical trial enrollment. The changing epidemiology of cancer in HIV poses challenges as well as opportunities for participation of persons with HIV in cancer therapy clinical trials. There are excellent examples of cancer trials that inform cancer therapy for patients with HIV infection. Examples include those from HIV-specific trials and from trials mainly focused on the background population that included patients with HIV infection. Interpretation of clinical trials to guide therapy for those with HIV infection and cancer largely depends on data that does not include HIV-infected patients. The ability to extend clinical trial findings to populations not included in clinical trials remains problematic for a variety of populations, including those with HIV or AIDS. Careful prioritization of studies designed to bridge this gap is needed. However, there are published studies that serve as excellent examples bridging these gaps and the portfolio of cancer therapy trials underway will inform HIV and cancer better than at any time in the past.

The effect of antenatal dietary and lifestyle advice for women who are overweight or obese on emotional well-being: the LIMIT randomized trial.

Science.gov (United States)

Dodd, Jodie M; Newman, Angela; Moran, Lisa J; Deussen, Andrea R; Grivell, Rosalie M; Yelland, Lisa N; Crowther, Caroline A; McPhee, Andrew J; Wittert, Gary; Owens, Julie A; Turnbull, Deborah; Robinson, Jeffrey S

2016-03-01

Our aim was to evaluate the effect of dietary and lifestyle advice given to women who were overweight or obese during pregnancy on maternal quality of life, anxiety and risk of depression, and satisfaction with care. We conducted a randomized trial, involving pregnant women with body mass index ≥25 kg/m(2) , recruited from maternity units in South Australia. Women were randomized to Lifestyle Advice or Standard Care, and completed questionnaires assessing risk of depression (Edinburgh Postnatal Depression Scale), anxiety (Spielberger State-Trait Anxiety Inventory), and quality of life (SF-36) at trial entry, 28 and 36 weeks' gestation, and 4 months postpartum. Secondary trial outcomes assessed for this analysis were risk of depression, anxiety, maternal quality of life, and satisfaction with care. One or more questionnaires were completed by 976 of 1108 (90.8%) women receiving Lifestyle Advice and 957 of 1104 (89.7%) women receiving Standard Care. The risk of depression [adjusted risk ratio 1.01; 95% confidence interval (CI) 0.82-1.24; p = 0.95], anxiety (adjusted risk ratio 1.09; 95% CI 0.93-1.27; p = 0.31), and health-related quality of life were similar between the two groups. Women receiving Lifestyle Advice reported improved healthy food choice [Lifestyle Advice 404 (68.9%) vs. Standard Care 323 (51.8%); p Lifestyle Advice 444 (75.8%) vs. Standard Care 367 (58.8%); p Lifestyle Advice 499 (85.3%) vs. Standard Care 485 (77.9%); p = 0.0112], and health of their baby [Lifestyle Advice 527 (90.2%) vs. Standard Care 545 (87.6%); p = 0.0143]. Lifestyle advice in pregnancy improved knowledge and provided reassurance without negatively impacting well-being. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

Nudging socially isolated people towards well-being with the 'Happiness Route': design of a randomized controlled trial for the evaluation of a happiness-based intervention.

Science.gov (United States)

Weiss, Laura A; Westerhof, Gerben J; Bohlmeijer, Ernst T

2013-09-20

psychology will be tackled with this study, such as having a target group who is especially vulnerable for low well-being. The practice-based setting is especially interesting, as it can give valuable insights in how positive psychology interventions work in practice, but can also give rise to several challenges. Dutch Trial Register, trial registration number TC=3377NTR.http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3377.

Preventing knee injuries in adolescent female football players - design of a cluster randomized controlled trial [NCT00894595].

Science.gov (United States)

Hägglund, Martin; Waldén, Markus; Atroshi, Isam

2009-06-23

Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL) injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT) to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. In this cluster randomized trial 516 teams (309 clusters) in eight regional football districts in Sweden with female players aged 13-17 years were randomized into an intervention group (260 teams) or a control group (256 teams). The teams in the intervention group were instructed to do a structured warm-up program at two training sessions per week throughout the 2009 competitive season (April to October) and those in the control group were informed to train and play as usual. Sixty-eight sports physical therapists are assigned to the clubs to assist both groups in data collection and to examine the players' acute knee injuries during the study period. Three different forms are used in the trial: (1) baseline player data form collected at the start of the trial, (2) computer-based registration form collected every month, on which one of the coaches/team leaders documents individual player exposure, and (3) injury report form on which the study therapists report acute knee injuries resulting in time loss from training or match play. The primary outcome is the incidence of ACL injury and the secondary outcomes are the incidence of any acute knee injury (except contusion) and incidence of severe knee injury (defined as injury resulting in absence of more than 4 weeks). Outcome measures are assessed after the end of the 2009 season. Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to be effective in reducing the incidence of knee

Growing Right Onto Wellness (GROW): a family-centered, community-based obesity prevention randomized controlled trial for preschool child-parent pairs.

Science.gov (United States)

Po'e, Eli K; Heerman, William J; Mistry, Rishi S; Barkin, Shari L

2013-11-01

Growing Right Onto Wellness (GROW) is a randomized controlled trial that tests the efficacy of a family-centered, community-based, behavioral intervention to prevent childhood obesity among preschool-aged children. Focusing on parent-child pairs, GROW utilizes a multi-level framework, which accounts for macro (i.e., built-environment) and micro (i.e., genetics) level systems that contribute to the childhood obesity epidemic. Six hundred parent-child pairs will be randomized to a 3-year healthy lifestyle intervention or a 3-year school readiness program. Eligible children are enrolled between ages 3 and 5, are from minority communities, and are not obese. The principal site for the GROW intervention is local community recreation centers and libraries. The primary outcome is childhood body mass index (BMI) trajectory at the end of the three-year study period. In addition to other anthropometric measurements, mediators and moderators of growth are considered, including genetics, accelerometry, and diet recall. GROW is a staged intensity intervention, consisting of intensive, maintenance, and sustainability phases. Throughout the study, parents build skills in nutrition, physical activity, and parenting, concurrently forming new social networks. Participants are taught goal-setting, self-monitoring, and problem solving techniques to facilitate sustainable behavior change. The GROW curriculum uses low health literacy communication and social media to communicate key health messages. The control arm is administered to both control and intervention participants. By conducting this trial in public community centers, and by implementing a family-centered approach to sustainable healthy childhood growth, we aim to develop an exportable community-based intervention to address the expanding public health crisis of pediatric obesity. © 2013.

One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial.

Science.gov (United States)

Strange, Simon; Whitehouse, Michael R; Beswick, Andrew D; Board, Tim; Burston, Amanda; Burston, Ben; Carroll, Fran E; Dieppe, Paul; Garfield, Kirsty; Gooberman-Hill, Rachael; Jones, Stephen; Kunutsor, Setor; Lane, Athene; Lenguerrand, Erik; MacGowan, Alasdair; Moore, Andrew; Noble, Sian; Simon, Joanne; Stockley, Ian; Taylor, Adrian H; Toms, Andrew; Webb, Jason; Whittaker, John-Paul; Wilson, Matthew; Wylde, Vikki; Blom, Ashley W

2016-02-17

Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months. The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients' and surgeons' experiences, including their views about trial participation and randomisation. INFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function

Systematic Review and Meta-Analysis of Randomized Controlled Trials of Xingnaojing Treatment for Stroke

Directory of Open Access Journals (Sweden)

Weijun Peng

2014-01-01

Full Text Available Objective. Xingnaojing injection (XNJ is a well-known traditional Chinese patent medicine (TCPM for stroke. The aim of this study is to assess the efficacy of XNJ for stroke including ischemic stroke, intracerebral hemorrhage (ICH, and subarachnoid hemorrhage (SAH. Methods. An extensive search was performed within using eight databases up to November 2013. Randomized controlled trials (RCTs on XNJ for treatment of stroke were collected. Study selection, data extraction, quality assessment, and meta-analysis were conducted according to the Cochrane standards, and RevMan5.0 was used for meta-analysis. Results. This review included 13 RCTs and a total of 1,514 subjects. The overall methodological quality was poor. The meta-analysis showed that XNJ combined with conventional treatment was more effective for total efficacy, neurological deficit improvement, and reduction of TNF-α levels compared with those of conventional treatment alone. Three trials reported adverse events, of these one trial reported mild impairment of kidney and liver function, whereas the other two studies failed to report specific adverse events. Conclusion. Despite the limitations of this review, we suggest that XNJ in combination with conventional medicines might be beneficial for the treatment of stroke. Currently there are various methodological problems in the studies. Therefore, high-quality, large-scale RCTs are urgently needed.

[Placebo-controlled trials in schizophrenia].

Science.gov (United States)

Melamed, Yuval; Davidson, Michael; Bleich, Avi

2004-03-01

Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow

The "Not Knowns": Memory, Narrative and Applied Theatre

Science.gov (United States)

Conroy, Colette; Dickenson, Sarah Jane; Mazzoni, Giuliana

2018-01-01

This is an attempt to articulate and explore the relationship between the science of memory and the applied theatre project, "The Not Knowns." The project was a collaboration between theatre practitioners and a psychologist who worked together with a group of young people known, problematically, as the "not knowns" throughout…

The landscape of precision cancer medicine clinical trials in the United States.

Science.gov (United States)

Roper, Nitin; Stensland, Kristian D; Hendricks, Ryan; Galsky, Matthew D

2015-05-01

Advances in tumor biology and multiplex genomic analysis have ushered in the era of precision cancer medicine. Little is currently known, however, about the landscape of prospective "precision cancer medicine" clinical trials in the U.S. We identified all adult interventional cancer trials registered on ClinicalTrials.gov between September 2005 and May 2013. Trials were classified as "precision cancer medicine" if a genomic alteration in a predefined set of 88 genes was required for enrollment. Baseline characteristics were ascertained for each trial. Of the initial 18,797 trials identified, 9094 (48%) were eligible for inclusion: 684 (8%) were classified as precision cancer medicine trials and 8410 (92%) were non-precision cancer medicine trials. Compared with non-precision cancer medicine trials, precision cancer medicine trials were significantly more likely to be phase II [RR 1.19 (1.10-1.29), pPrecision medicine trials required 38 unique genomic alterations for enrollment. The proportion of precision cancer medicine trials compared to the total number of trials increased from 3% in 2006 to 16% in 2013. The proportion of adult cancer clinical trials in the U.S. requiring a genomic alteration for enrollment has increased substantially over the past several years. However, such trials still represent a small minority of studies performed within the cancer clinical trials enterprise and include a small subset of putatively "actionable" alterations. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation of systematic assessment of asthma-like symptoms and tobacco smoke exposure in early childhood by well-child professionals: a randomised trial.

Directory of Open Access Journals (Sweden)

Esther Hafkamp-de Groen

Full Text Available This study aimed to evaluate the effectiveness of systematic assessment of asthma-like symptoms and environmental tobacco smoke (ETS exposure during regular preventive well-child visits between age 1 and 4 years by well-child professionals.Sixteen well-child centres in Rotterdam, the Netherlands, were randomised into 8 centres where the brief assessment form regarding asthma-like symptoms and ETS exposure was used and 8 centres that applied usual care. 3596 and 4179 children (born between April 2002 and January 2006 and their parents visited the intervention and control centres, respectively. At child's age 6 years, physician-diagnosed asthma ever, wheezing, fractional exhaled nitric oxide (FeNO, airway resistance (Rint, health-related quality of life (HRQOL and ETS exposure at home ever were measured. Linear mixed models were applied.No differences in asthma, wheezing, FeNO, Rint or HRQOL measurements between intervention and control group were found using multilevel regression in an intention-to-treat analysis (p>0.05. Children of whom the parents were interviewed by using the brief assessment form at the intervention well-child centres had a decreased risk on ETS exposure at home ever, compared to children who visited the control well-child centres, in an explorative per-protocol analysis (aOR = 0.71, 95% CI:0.59-0.87.Systematic assessment and counselling of asthma-like symptoms and ETS exposure in early childhood by well-child care professionals using a brief assessment form was not effective in reducing the prevalence of physician-diagnosed asthma ever and wheezing, and did not improve FeNO, Rint or HRQOL at age 6 years. Our results hold some promise for interviewing parents and using information leaflets at well-child centres to reduce ETS exposure at home in preschool children.Controlled-Trials.com ISRCTN15790308.

Evaluation of systematic assessment of asthma-like symptoms and tobacco smoke exposure in early childhood by well-child professionals: a randomised trial.

Science.gov (United States)

Hafkamp-de Groen, Esther; van der Valk, Ralf J P; Mohangoo, Ashna D; van der Wouden, Johannes C; Duijts, Liesbeth; Jaddoe, Vincent W; Hofman, Albert; de Koning, Harry J; de Jongste, Johan C; Raat, Hein

2014-01-01

This study aimed to evaluate the effectiveness of systematic assessment of asthma-like symptoms and environmental tobacco smoke (ETS) exposure during regular preventive well-child visits between age 1 and 4 years by well-child professionals. Sixteen well-child centres in Rotterdam, the Netherlands, were randomised into 8 centres where the brief assessment form regarding asthma-like symptoms and ETS exposure was used and 8 centres that applied usual care. 3596 and 4179 children (born between April 2002 and January 2006) and their parents visited the intervention and control centres, respectively. At child's age 6 years, physician-diagnosed asthma ever, wheezing, fractional exhaled nitric oxide (FeNO), airway resistance (Rint), health-related quality of life (HRQOL) and ETS exposure at home ever were measured. Linear mixed models were applied. No differences in asthma, wheezing, FeNO, Rint or HRQOL measurements between intervention and control group were found using multilevel regression in an intention-to-treat analysis (p>0.05). Children of whom the parents were interviewed by using the brief assessment form at the intervention well-child centres had a decreased risk on ETS exposure at home ever, compared to children who visited the control well-child centres, in an explorative per-protocol analysis (aOR = 0.71, 95% CI:0.59-0.87). Systematic assessment and counselling of asthma-like symptoms and ETS exposure in early childhood by well-child care professionals using a brief assessment form was not effective in reducing the prevalence of physician-diagnosed asthma ever and wheezing, and did not improve FeNO, Rint or HRQOL at age 6 years. Our results hold some promise for interviewing parents and using information leaflets at well-child centres to reduce ETS exposure at home in preschool children. Controlled-Trials.com ISRCTN15790308.

Free choice access to multipoint wellness education and related services positively impacts employee wellness: a randomized and controlled trial.

Science.gov (United States)

Sforzo, Gary A; Kaye, Miranda P; Calleri, David; Ngai, Nancy

2012-04-01

Examine effects of voluntary participation in employer-sponsored, multipoint wellness education programming on employee wellness. A randomized and controlled design was used to organize 96 participants into an education + access group; an access-only group, and control group. Outcome measures were made at start and end of a 12-week intervention period. Education + access improved wellness knowledge, which, in turn, enhanced life satisfaction, employee morale, and energy, and nearly improved stress level. Those who received facility access without educational programming did not reap health benefits. Employees voluntarily used the fitness facility and healthy meal cards only 1.3 and 1.5 times per week, respectively. Participants made limited and likely inadequate use of wellness opportunities. As a result, physical health benefits (eg, blood pressure, fitness parameters) were not seen in the present study. However, multipoint wellness education resulted in psychosocial health benefits in 12 weeks.

Exponentially-convergent Monte Carlo via finite-element trial spaces

International Nuclear Information System (INIS)

Morel, Jim E.; Tooley, Jared P.; Blamer, Brandon J.

2011-01-01

Exponentially-Convergent Monte Carlo (ECMC) methods, also known as adaptive Monte Carlo and residual Monte Carlo methods, were the subject of intense research over a decade ago, but they never became practical for solving the realistic problems. We believe that the failure of previous efforts may be related to the choice of trial spaces that were global and thus highly oscillatory. As an alternative, we consider finite-element trial spaces, which have the ability to treat fully realistic problems. As a first step towards more general methods, we apply piecewise-linear trial spaces to the spatially-continuous two-stream transport equation. Using this approach, we achieve exponential convergence and computationally demonstrate several fundamental properties of finite-element based ECMC methods. Finally, our results indicate that the finite-element approach clearly deserves further investigation. (author)

The pursuit of balance in sequential randomized trials

Directory of Open Access Journals (Sweden)

Raymond P. Guiteras

2016-06-01

Full Text Available In many randomized trials, subjects enter the sample sequentially. Because the covariates for all units are not known in advance, standard methods of stratification do not apply. We describe and assess the method of DA-optimal sequential allocation (Atkinson, 1982 for balancing stratification covariates across treatment arms. We provide simulation evidence that the method can provide substantial improvements in precision over commonly employed alternatives. We also describe our experience implementing the method in a field trial of a clean water and handwashing intervention in Dhaka, Bangladesh, the first time the method has been used. We provide advice and software for future researchers.

Blind trials of computer-assisted structure elucidation software

Directory of Open Access Journals (Sweden)

Moser Arvin

2012-02-01

Full Text Available Abstract Background One of the largest challenges in chemistry today remains that of efficiently mining through vast amounts of data in order to elucidate the chemical structure for an unknown compound. The elucidated candidate compound must be fully consistent with the data and any other competing candidates efficiently eliminated without doubt by using additional data if necessary. It has become increasingly necessary to incorporate an in silico structure generation and verification tool to facilitate this elucidation process. An effective structure elucidation software technology aims to mimic the skills of a human in interpreting the complex nature of spectral data while producing a solution within a reasonable amount of time. This type of software is known as computer-assisted structure elucidation or CASE software. A systematic trial of the ACD/Structure Elucidator CASE software was conducted over an extended period of time by analysing a set of single and double-blind trials submitted by a global audience of scientists. The purpose of the blind trials was to reduce subjective bias. Double-blind trials comprised of data where the candidate compound was unknown to both the submitting scientist and the analyst. The level of expertise of the submitting scientist ranged from novice to expert structure elucidation specialists with experience in pharmaceutical, industrial, government and academic environments. Results Beginning in 2003, and for the following nine years, the algorithms and software technology contained within ACD/Structure Elucidator have been tested against 112 data sets; many of these were unique challenges. Of these challenges 9% were double-blind trials. The results of eighteen of the single-blind trials were investigated in detail and included problems of a diverse nature with many of the specific challenges associated with algorithmic structure elucidation such as deficiency in protons, structure symmetry, a large number of

Qualitative "trial-sibling" studies and "unrelated" qualitative studies contributed to complex intervention reviews.

Science.gov (United States)

Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash

2016-06-01

To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

Sequential Multiple Assignment Randomized Trials: An Opportunity for Improved Design of Stroke Reperfusion Trials.

Science.gov (United States)

Meurer, William J; Seewald, Nicholas J; Kidwell, Kelley

2017-04-01

Modern clinical trials in stroke reperfusion fall into 2 categories: alternative systemic pharmacological regimens to alteplase and "rescue" endovascular approaches using targeted thrombectomy devices and/or medications delivered directly for persistently occluded vessels. Clinical trials in stroke have not evaluated how initial pharmacological thrombolytic management might influence subsequent rescue strategy. A sequential multiple assignment randomized trial (SMART) is a novel trial design that can test these dynamic treatment regimens and lead to treatment guidelines that more closely mimic practice. To characterize a SMART design in comparison to traditional approaches for stroke reperfusion trials. We conducted a numerical simulation study that evaluated the performance of contrasting acute stroke clinical trial designs of both initial reperfusion and rescue therapy. We compare a SMART design where the same patients are followed through initial reperfusion and rescue therapy within 1 trial to a standard phase III design comparing 2 reperfusion treatments and a separate phase II futility design of rescue therapy in terms of sample size, power, and ability to address particular research questions. Traditional trial designs can be well powered and have optimal design characteristics for independent treatment effects. When treatments, such as the reperfusion and rescue therapies, may interact, commonly used designs fail to detect this. A SMART design, with similar sample size to standard designs, can detect treatment interactions. The use of SMART designs to investigate effective and realistic dynamic treatment regimens is a promising way to accelerate the discovery of new, effective treatments for stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Despite being known as the Wild Coast, owing to its rough seas and ...

African Journals Online (AJOL)

spamer

Despite being known as the Wild Coast, owing to its rough seas and ...... prognosis for the skiboat fishery is not good. Com- ... from the Margate/Port Edward area, as well as Messrs. G. Meyers from ... FIELDING, P. J., ROBERTSON, W. D., DYE, A. H., TOMALIN, ... HARRISON, T. D., COOPER, J. A. G. and A. E. L. RAMM 2000.

Marketing and clinical trials: a case study.

Science.gov (United States)

Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

2007-11-20

Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

New expectations from the well-known medicinal properties of Arctium lappa.

Science.gov (United States)

Miele, C; Beguinot, F

2012-05-01

AMP-activated protein kinase (AMPK) serves as a major regulator of energy homeostasis and is activated by different glucose-lowering agents. Indeed, AMPK has been identified as an attractive target for the development of innovative molecules to treat type 2 diabetes. In this issue of Diabetologia (doi: 10.1007/s00125-011-2366-3 ), Huang and co-workers report that arctigenin activates muscle uptake of glucose and inhibits hepatocyte gluconeogenesis and lipogenesis by reducing mitochondrial respiration and inducing AMPK activity. Importantly, it is reported that arctigenin improves glucose and lipid metabolism in ob/ob mice. Based on this evidence, Huang and co-workers suggest that arctigenin may represent a valuable lead compound for developing innovative glucose-lowering molecules. While these findings are not entirely novel and mechanistic investigations are needed, the results strongly support the concept that arctigenin deserves to be further considered because of its several potentially beneficial in vivo effects. In particular, the authors conclude that further mechanistic studies on arctigenin might provide novel insight and opportunities for selective modulation of subcutaneous and visceral fat mass.

Comparing the personality of three well-known sporting brands in Iran

OpenAIRE

Mohmood Mohammadian; Hamidreza Asgari Dehabadi

2012-01-01

A significant amount of literature specifies that there are benefits for having a favorable brand personality, such as purchase intentions and enhanced brand attitudes and higher degrees of consumer trust and loyalty. Brand differentiation is one of most important issues to handle competition in the hostile marketplace. A reliable solution for establishing the distinctiveness of a brand is through brand personality. This study analyzes the personality of Adidas, Nike and Puma brands in Iran u...

View points on a not well known law, the nuclear law

International Nuclear Information System (INIS)

Arbousset, Herve; Lahorgue, Marie-Beatrice; Rambour, Muriel; Schellenberger, Thomas

2018-01-01

While indicating the relevant French decrees and laws which have been building up what can be called the nuclear law, this article first proposes a discussed overview of the evolution of this law between a decree published in 1963 and the law on energy transition, while noticing what went in the USA in this respect. Based on the example of the project of geological storage of nuclear wastes, the authors outline that this nuclear law is evolving out of standards as it is evolves in order to fit with the project, and not the other way. Therefore democratic anchoring is rather fragile. The author outlines the influence of new threats related to terrorism and their influence on the nuclear law. They also comment the issue of compensation for victims of French nuclear tests in Algeria and in French Polynesia, and notice that hope has been followed by disillusion and questions

Zika virus disease: a new look at a well-known disease

Directory of Open Access Journals (Sweden)

I. V. Shestakova

2016-01-01

Full Text Available For the first time in the domestic medical literature presents a deep review about epidemiological, clinical, and laboratory knowledge of Zika virus disease, based mainly on the publications of foreign authors and leading international organizations from 1947 to March 2016. Analyzed the essence of the problem, treatment of patients with Zika virus disease and infected pregnant women, indicated the unresolved question. For the first time were systematic sources of contemporary information about Zika virus disease for professionals and patients.

Although the effects of climate change on crops are well known ...

African Journals Online (AJOL)

tina

Climate change and livestock production: A review with emphasis on Africa. J.M. Rust. # .... which African farmers adapted livestock management to the range of climates across the continent. A ..... In: Handbook of methods for climate change ...

Comparing the personality of three well-known sporting brands in Iran

Directory of Open Access Journals (Sweden)

Mohmood Mohammadian

2012-08-01

Full Text Available A significant amount of literature specifies that there are benefits for having a favorable brand personality, such as purchase intentions and enhanced brand attitudes and higher degrees of consumer trust and loyalty. Brand differentiation is one of most important issues to handle competition in the hostile marketplace. A reliable solution for establishing the distinctiveness of a brand is through brand personality. This study analyzes the personality of Adidas, Nike and Puma brands in Iran using Aaker,s brand personality dimensions [Aakar (1997. Dimensions of brand personality. Journal of Marketing Resources, 24, 347–356]. First, data are collected using a questionnaire designed based on Aaker,s model. Second, the K-S and Friedman tests are done to analyze the collected data. Results indicate that in terms of sincerity and competence, Adidas scores are higher than two other brands. Nike in point of view of excitement, and Puma in terms of sophisticated and ruggedness dimensions have higher position in comparison to other brands.

The well-being and personal wellness promotion strategies of medical oncologists in the North Central Cancer Treatment Group.

Science.gov (United States)

Shanafelt, Tait D; Novotny, Paul; Johnson, Mary E; Zhao, Xinghua; Steensma, David P; Lacy, Martha Q; Rubin, Joseph; Sloan, Jeff

2005-01-01

The well-being of oncologists is important to the well-being of their patients. While much is known about oncologist distress, little is known about oncologist well-being. We set out to evaluate oncologist well-being and the personal wellness promotion strategies used by oncologists. We performed a cross-sectional survey of medical oncologists in the North Central Cancer Treatment Group using a validated instrument to measure quality of life. Study-specific questions explored stressors, wellness promotion strategies and career satisfaction. Of 241 responding oncologists (response rate 61%), 121 (50%) reported high overall well-being. Being age 50 or younger (57 vs. 41%; p = 0.01), male (53 vs. 31%; p = 0.01) and working 60 h or less per week (50 vs. 33%; p = 0.005) were associated with increased overall well-being on bivariate analysis. Ratings of the importance of a number of personal wellness promotion strategies differed for oncologists with high well-being compared with those without high well-being. Developing an approach/philosophy to dealing with death and end-of-life care, using recreation/hobbies/exercise, taking a positive outlook and incorporating a philosophy of balance between personal and professional life were all rated as substantially more important wellness strategies by oncologists with high well-being (p values career satisfaction. Half of medical oncologists experience high overall well-being. Use of specific personal wellness promotion strategies appears to be associated with oncologist well-being. Further investigations of the prevalence, promotion, causes, inequities and clinical impact of physician well-being are needed. .

Data from the German Chest Pain Unit Registry: The well known gap between knowledge and practice.

Science.gov (United States)

Fernández-Bergés, Daniel

2017-11-01

In-hospital mortality of acute myocardial infarction with ST segment elevation remains high and is influenced by many factors, some of which are modifiable such as time to treatment initiation and modality of treatment. It is well established that reperfusion therapy is the gold-standard in the management of ST-elevation acute myocardial infarction. Despite recent developments and clear, comprehensible guidelines recommendations, it remains difficult to disseminate this knowledge to medical practitioners. The German Chest Pain Unit shows that the best door-to-balloon time is reached when patients contact the Emergency Medical Systems (EMS) directly, rather than when referred by the general practitioner (GP), or are transferred from another hospital, or present as a self-referral. In order to improve mortality in ST-elevation acute myocardial infarction, patients must be able to recognize symptoms and call the EMS as soon as possible, in addition to having an ECG within ten minutes and direct access to reperfusion therapy (PPCI preferred). The German Registry has highlighted the importance of training both patients and doctors. Copyright © 2017 Elsevier B.V. All rights reserved.

Tai Chi on psychological well-being: systematic review and meta-analysis

Directory of Open Access Journals (Sweden)

Scott Tammy

2010-05-01

Full Text Available Abstract Background Physical activity and exercise appear to improve psychological health. However, the quantitative effects of Tai Chi on psychological well-being have rarely been examined. We systematically reviewed the effects of Tai Chi on stress, anxiety, depression and mood disturbance in eastern and western populations. Methods Eight English and 3 Chinese databases were searched through March 2009. Randomized controlled trials, non-randomized controlled studies and observational studies reporting at least 1 psychological health outcome were examined. Data were extracted and verified by 2 reviewers. The randomized trials in each subcategory of health outcomes were meta-analyzed using a random-effects model. The quality of each study was assessed. Results Forty studies totaling 3817 subjects were identified. Approximately 29 psychological measurements were assessed. Twenty-one of 33 randomized and nonrandomized trials reported that 1 hour to 1 year of regular Tai Chi significantly increased psychological well-being including reduction of stress (effect size [ES], 0.66; 95% confidence interval [CI], 0.23 to 1.09, anxiety (ES, 0.66; 95% CI, 0.29 to 1.03, and depression (ES, 0.56; 95% CI, 0.31 to 0.80, and enhanced mood (ES, 0.45; 95% CI, 0.20 to 0.69 in community-dwelling healthy participants and in patients with chronic conditions. Seven observational studies with relatively large sample sizes reinforced the beneficial association between Tai Chi practice and psychological health. Conclusions Tai Chi appears to be associated with improvements in psychological well-being including reduced stress, anxiety, depression and mood disturbance, and increased self-esteem. Definitive conclusions were limited due to variation in designs, comparisons, heterogeneous outcomes and inadequate controls. High-quality, well-controlled, longer randomized trials are needed to better inform clinical decisions.

Quantum signature scheme for known quantum messages

International Nuclear Information System (INIS)

Kim, Taewan; Lee, Hyang-Sook

2015-01-01

When we want to sign a quantum message that we create, we can use arbitrated quantum signature schemes which are possible to sign for not only known quantum messages but also unknown quantum messages. However, since the arbitrated quantum signature schemes need the help of a trusted arbitrator in each verification of the signature, it is known that the schemes are not convenient in practical use. If we consider only known quantum messages such as the above situation, there can exist a quantum signature scheme with more efficient structure. In this paper, we present a new quantum signature scheme for known quantum messages without the help of an arbitrator. Differing from arbitrated quantum signature schemes based on the quantum one-time pad with the symmetric key, since our scheme is based on quantum public-key cryptosystems, the validity of the signature can be verified by a receiver without the help of an arbitrator. Moreover, we show that our scheme provides the functions of quantum message integrity, user authentication and non-repudiation of the origin as in digital signature schemes. (paper)

Randomized controlled trial of a six-week spiritual reminiscence intervention on hope, life satisfaction, and spiritual well-being in elderly with mild and moderate dementia.

Science.gov (United States)

Wu, Li-Fen; Koo, Malcolm

2016-02-01

Reminiscence therapy has been reported to improve the well-being in patients with dementia. However, few studies have examined the effects of spiritual reminiscence, which emphasizes on reconnecting and enhancing the meaning of one's own experience, on patients with dementia. Therefore, this study aimed to investigate the effects of spiritual reminiscence on hope, life satisfaction, and spiritual well-being in elderly Taiwanese with mild or moderate dementia. A randomized controlled trial was conducted on 103 patients with mild or moderate dementia recruited from a medical center in central Taiwan. The patients were randomly assigned to either a 6-week spiritual reminiscence group (n = 53) or control group (n = 50). The Herth Hope Index, the Life Satisfaction Scale, the Spirituality Index of Well-Being were administered before and after the 6-week period. The interaction terms between group and time for the three outcome measures were found to be significant (P hope, life satisfaction, and spiritual well-being of elderly patients with mild or moderate dementia could significantly be improved with a 6-week spiritual reminiscence intervention. Copyright © 2015 John Wiley & Sons, Ltd.

A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music.

Science.gov (United States)

Rennick, Janet E; Stremler, Robyn; Horwood, Linda; Aita, Marilyn; Lavoie, Tanya; Majnemer, Annette; Antonacci, Marie; Knox, Alyssa; Constantin, Evelyn

2018-04-13

To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Nonblinded, pilot randomized controlled trial. The PICU and medical-surgical wards of one Canadian pediatric hospital. Twenty PICU patients age 2-14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness.

Molecular medicine of fragile X syndrome: based on known molecular mechanisms.

Science.gov (United States)

Luo, Shi-Yu; Wu, Ling-Qian; Duan, Ran-Hui

2016-02-01

Extensive research on fragile X mental retardation gene knockout mice and mutant Drosophila models has largely expanded our knowledge on mechanism-based treatment of fragile X syndrome (FXS). In light of these findings, several clinical trials are now underway for therapeutic translation to humans. Electronic literature searches were conducted using the PubMed database and ClinicalTrials.gov. The search terms included "fragile X syndrome", "FXS and medication", "FXS and therapeutics" and "FXS and treatment". Based on the publications identified in this search, we reviewed the neuroanatomical abnormalities in FXS patients and the potential pathogenic mechanisms to monitor the progress of FXS research, from basic studies to clinical trials. The pathological mechanisms of FXS were categorized on the basis of neuroanatomy, synaptic structure, synaptic transmission and fragile X mental retardation protein (FMRP) loss of function. The neuroanatomical abnormalities in FXS were described to motivate extensive research into the region-specific pathologies in the brain responsible for FXS behavioural manifestations. Mechanism-directed molecular medicines were classified according to their target pathological mechanisms, and the most recent progress in clinical trials was discussed. Current mechanism-based studies and clinical trials have greatly contributed to the development of FXS pharmacological therapeutics. Research examining the extent to which these treatments provided a rescue effect or FMRP compensation for the developmental impairments in FXS patients may help to improve the efficacy of treatments.

Can emergency medicine research benefit from adaptive design clinical trials?

Science.gov (United States)

Flight, Laura; Julious, Steven A; Goodacre, Steve

2017-04-01

Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Marketing and clinical trials: a case study

Directory of Open Access Journals (Sweden)

Entwistle Vikki A

2007-11-01

Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

The ADAS-Cog revisited: novel composite scales based on ADAS-Cog to improve efficiency in MCI and early AD trials.

Science.gov (United States)

Raghavan, Nandini; Samtani, Mahesh N; Farnum, Michael; Yang, Eric; Novak, Gerald; Grundman, Michael; Narayan, Vaibhav; DiBernardo, Allitia

2013-02-01

The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) has been used widely as a cognitive end point in Alzheimer's Disease (AD) clinical trials. Efforts to treat AD pathology at earlier stages have also used ADAS-Cog, but failure in these trials can be difficult to interpret because the scale has well-known ceiling effects that limit its use in mild cognitive impairment (MCI) and early AD. A wealth of data exists in ADAS-Cog from both historical trials and contemporary longitudinal natural history studies that can provide insights about parts of the scale that may be better suited for MCI and early AD trials. Using Alzheimer's Disease Neuroimaging Initiative study data, we identified the most informative cognitive measures from the ADAS-Cog and other available scales. We used cross-sectional analyses to characterize trajectories of ADAS-Cog and its individual subscales, as well as other cognitive, functional, or global measures across disease stages. Informative measures were identified based on standardized mean of 2-year change from baseline and were combined into novel composite endpoints. We assessed performance of the novel endpoints based on sample size requirements for a 2-year clinical trial. A bootstrap validation procedure was also undertaken to assess the reproducibility of the standardized mean changes of the selected measures and the corresponding composites. All proposed novel endpoints have improved standardized mean changes and thus improved statistical power compared with the ADAS-Cog 11. Further improvements were achieved by using cognitive-functional composites. Combining the novel composites with an enrichment strategy based on cerebral spinal fluid beta-amyloid (Aβ(1-42)) in a 2-year trial yielded gains in power of 20% to 40% over ADAS-Cog 11, regardless of the novel measure considered. An empirical, data-driven approach with existing instruments was used to derive novel composite scales based on ADAS-Cog 11 with improved performance

Brain Tumor Trials Collaborative | Center for Cancer Research

Science.gov (United States)

Brain Tumor Trials Collaborative In Pursuit of a Cure The mission of the BTTC is to develop and perform state-of-the-art clinical trials in a collaborative and collegial environment, advancing treatments for patients with brain tumors, merging good scientific method with concern for patient well-being and outcome.

Síndrome de Rett: 50 años de historia de un trastorno aun no bien conocido Rett syndrome: 50 years' history of a still not well known condition

Directory of Open Access Journals (Sweden)

Jaime Campos-Castello

2007-01-01

Full Text Available Desde que fue descrito por primera vez por Andreas Rett hace 50 años, el síndrome de Rett (SR ha sido objeto de muchas investigaciones, sin embargo continúa siendo un trastorno aún no bien conocido. Presentamos nuestra propia experiencia y una revisión de la literatura sobre el SR. Se trata de un trastorno del neurodesarrollo, dominante ligado a X, que afecta casi siempre a mujeres, la mayoría de los casos de forma esporádica. El diagnóstico de SR debe hacerse en base a la observación clínica. Las principales características son la aparición de un retraso mental, cambios conductuales, estereotipias, pérdida del lenguaje y, sobre todo, del uso propositivo de las manos, aparición de una apraxia de la marcha, presencia de alteraciones de la respiración y, frecuentemente, crisis epilépticas. Los criterios diagnósticos consensuados internacionalmente son aquí revisados. El SR se debe en la mayoría de casos a mutaciones del gen MECP2, si bien una proporción de casos atípicos puede estar causada por mutaciones de CDKL5, particularmente la variante con epilepsia precoz. Sin embargo, los mecanismos patogénicos moleculares no son bien conocidos, así como la relación entre las mutaciones de MECP2 y otros trastornos del desarrollo. Revisamos también los hallazgos de neuroimagen, neuropatológicos y neurobioquímicos descritos en el SR. Respecto al tratamiento, aparte del sintomático, no hay ninguno que se haya mostrado eficaz. Un trabajo reciente abre perspectivas terapéuticas futuras al haber demostrado mediante un modelo animal de ratón la reversión de los síntomas neurológicos mediante la activación de la expresión de MeCP2.Since it was first described by Andrea Rett 50 years ago, Rett syndrome (RS has been the subject of further investigations, nonetheless it continues to be a not well known condition. Our own experience and an updated literature review on RS is presented. RS is a severe dominant X chromosome

Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis.

OpenAIRE

Thomas, Sarah; Fazakarley, Louise; Thomas, Peter; Collyer, S.; Brenton, S.; Perring, S.; Scott, R.; Thomas, F.; Thomas, C.; Jones, K.; Hickson, J.; Hillier, C.

2017-01-01

OBJECTIVES: While the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention. DESIGN: A single-centre wait-l...

Developments in clinical trials: a Pharma Matters report.

Science.gov (United States)

Arjona, A; Nuskey, B; Rabasseda, X; Arias, E

2014-08-01

As the pharmaceutical industry strives to meet the ever-increasing complexity of drug development, new technology in clinical trials has become a beacon of hope. With big data comes the promise of accelerated patient recruitment, real-time monitoring of clinical trials, bioinformatics empowerment of quicker phase progression, and the overwhelming benefits of precision medicine for select trials. Risk-based monitoring stands to benefit as well. With a strengthening focus on centralized data by the FDA and industry's transformative initiative, TransCelerate, a new era in trial risk mitigation has begun. The traditional method of intensive on-site monitoring is becoming a thing of the past as statistical, real-time analysis of site and trial-wide data provides the means to monitor with greater efficiency and effectiveness from afar. However, when it comes to big data, there are challenges that lie ahead. Patient privacy, commercial investment protection, technology woes and data variability are all limitations to be met with considerable thought. At the Annual Meeting of the American Academy of Dermatology this year, clinical trials on psoriasis, atopic dermatitis and other skin diseases were discussed in detail. This review of clinical research reports on novel therapies for psoriasis and atopic dermatitis reveals the impact of these diseases and the drug candidates that have been successful in phase II and III studies. Data-focused highlights of novel dermatological trials, as well as real-life big data approaches and an insight on the new methodology of risk-based monitoring, are all discussed in this edition of Developments in Clinical Trials. Copyright 2014 Prous Science, S.A.U. or its licensors. All rights reserved.

Personalized Web-Based Advice in Combination With Well-Child Visits to Prevent Overweight in Young Children: Cluster Randomized Controlled Trial.

Science.gov (United States)

van Grieken, Amy; Vlasblom, Eline; Wang, Lu; Beltman, Maaike; Boere-Boonekamp, Magda M; L'Hoir, Monique P; Raat, Hein

2017-07-27

Overweight is a major health issue, and parent-targeted interventions to promote healthy development in children are needed. The study aimed to evaluate E-health4Uth Healthy Toddler, an intervention that educates parents of children aged 18 to 24 months regarding health-related behaviors, as compared with usual care. The effect of this intervention on the following primary outcomes was evaluated when the children were 36 months of age: health-related behaviors (breakfast daily, activity and outside play, sweetened beverage consumption, television (TV) viewing and computer time), body mass index (BMI), and the prevalence of overweight and obesity. The BeeBOFT (acronym for breastfeeding, breakfast daily, outside playing, few sweet drinks, less TV viewing) study is a cluster randomized controlled trial involving 51 Youth Health Care (YHC) teams. In total, 1094 parents participated in the control group, and 1008 parents participated in the E-health4Uth Healthy Toddler intervention group. The intervention consisted of Web-based personalized advice given to parents who completed an eHealth module and discussion of the advice during a regular well-child visit. In this study the eHealth module was offered to parents before two regular well-child visits at 18 and 24 months of age. During the well-child visits, the parents' personalized advice was combined with face-to-face counseling provided by the YHC professional. Parents in the control group received usual care, consisting of the regular well-child visits during which general information on child health-related behavior was provided to parents. Parents completed questionnaires regarding family characteristics and health-related behaviors when the child was 1 month (inclusion), 6 months, 14 months, and 36 months (follow-up) of age. The child's height and weight were measured by trained health care professionals from birth through 36 months of age at fixed time points. Multilevel linear and logistic regression models were

Using e-technologies in clinical trials.

Science.gov (United States)

Rosa, Carmen; Campbell, Aimee N C; Miele, Gloria M; Brunner, Meg; Winstanley, Erin L

2015-11-01

Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored. Published by Elsevier Inc.

Amazing wells

Energy Technology Data Exchange (ETDEWEB)

Ross, E.; Leschart, M.; Mahoney, J.; Smith, M.

2002-02-01

Six wells and a drilling rig, setting company, national and world records such as deepest well, longest horizontal well, and record setting completion technology are described. Steam assisted gravity drainage (SAGD) is mainly responsible for these outstanding successes. Discovered more than 20 years ago by a then Imperial oil scientist (Dr. Roger Butler) SAGD promises recovery rates of about 70 per cent for the right reservoir; more than twice the 25 to 30 per cent recovery rate with cyclic stimulation at Cold Lake and an average recovery rate of about 28 per cent for all Alberta light, medium and heavy oil wells. The seven facilities discussed in this article are : (1) Alberta Energy Company's Forest Hill oil sands project near Cold Lake, the first commercial SAGD operation where well pairs are producing 1,200-1,500 bbls per day; (2) Talisman Energy's Lovett River wells, which hold the company's depth record for a horizontal well in the Alberta Foothills; (3) Also owned by Talisman Energy in the Buchan Field in the North Sea, this well is famous for the fact that it was drilled with coiled tubing from a floating production vessel; : (4) in the Peco Field, south of Edson Alberta and owned by EOG Resources Canada, this well holds the Canadian offshore record for a single run using rotary steerable technology; (5) Burlington Resources Canada 's Burlington HZ Hinton 2-34-52-26 W5M well is best known for its record setting extended reach open hole coiled tubing job; (6) another Burlington Resources well holds the record for the deepest one-trip whipstock system ever run in Canada and milled successfully in one trip; and (7) a drilling rig in the Wabasca-Brintnell area of northern Alberta, owned by Canadian Natural Resources Limited, holds the record for drilling the largest number of horizontal holes in one year with the same rig.

Treatment of anemia in chronic kidney disease: known, unknown, and both

Directory of Open Access Journals (Sweden)

Foley RN

2011-08-01

Full Text Available Robert N FoleyChronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, MN, USAAbstract: Erythropoiesis is a rapidly evolving research arena and several mechanistic insights show therapeutic promise. In contrast with the rapid advance of mechanistic science, optimal management of anemia in patients with chronic kidney disease remains a difficult and polarizing issue. Although several large hemoglobin target trials have been performed, optimal treatment targets remain elusive, because none of the large trials to date have unequivocally identified differences in primary outcome rates or death rates, and because other reported outcomes indicate the potential for harm (rates of stroke, early requirement for dialysis, and vascular access thrombosis and benefit (reductions in transfusion requirements and fatigue.Keywords: hemoglobin, erythropoietin, oxygen-sensing, target trial, methodology

Bound states for square well potentials extending to infinity in D ≥ 2

International Nuclear Information System (INIS)

Rupertsberger, H.

1992-01-01

It is well known that quantum mechanics allows the penetration into classically forbidden regions (tunneling). Less well known seems to be the fact that in some sense the converse is true also. Potentials with classically allowed regions where a particle can move freely to infinity can nevertheless lead to bound states in quantum mechanics due to the stringent requirements of the boundary conditions, thus forbidding an escape to infinity. This effect is demonstrated by using an obvious generalization of the well known one-dimensional (D = 1) square well potential to arbitray space dimensions. (author)

Unilateral or bilateral laparoscopic ovarian drilling in polycystic ovary syndrome: a meta-analysis of randomized trials.

Science.gov (United States)

Abu Hashim, Hatem; Foda, Osama; El Rakhawy, Mohamed

2018-04-01

This systematic review and meta-analysis aimed to compare the effectiveness of unilateral vs. bilateral laparoscopic ovarian drilling (ULOD vs. BLOD) for improving fertility outcomes in infertile women with clomiphene-resistant polycystic ovary syndrome (PCOS) as well as its effect on ovarian reserve. Searches were conducted on PubMed, ScienceDirect, ClinicalTrials.gov, and CENTRAL databases from January 1984 to January 2017. Only randomized trials comparing ULOD with BLOD were included. The PRISMA Statement was followed. Main outcomes were ovulation and clinical pregnancy rates per woman randomized. Secondary outcomes were; live birth and miscarriage rates as well as postoperative serum anti-mullerian hormone (AMH) concentration and antral follicle count (AFC). Quality assessment was performed by the Cochrane Collaboration risk of bias tool. Eight eligible trials (484 women) were analyzed. No significant difference was found in rates of ovulation (OR 0.73; 95% CI 0.47-1.11), clinical pregnancy (OR 0.56; 95% CI 0.22-1.41), live birth (OR 0.77; 95% CI 0.28-2.10), or miscarriage (OR 0.90; 95% CI 0.33-2.84) when ULOD was compared with BLOD. The reduction in AMH was comparable between the two procedures (MD 0.64 ng/ml; 95% CI - 0.08 to 1.36). A significantly higher AFC at 6-month follow-up was found with dose-adjusted ULOD (MD 2.20; 95% CI 1.01-3.39). After carefully weighing up the well-known benefits of BLOD against a potential risk to ovarian reserve, clinicians could be advised to offer the fixed-dose ULOD to their infertile patients with clomiphene-resistant PCOS. This is concordant with the "primum non nocere" principal if LOD will be envisaged.

Clinical trial participation. Viewpoints from racial/ethnic groups.

Science.gov (United States)

Roberson, N L

1994-11-01

Racial/ethnic groups' participation in clinical trials is a relatively new area of research that warrants attention. Although racial/ethnic groups have been included in experimental studies since the 1940s, they were not included in significant numbers in clinical trials for cancer. Clinical trials play a dominant role in clinical oncology. Despite this state-of-the-art cancer treatment, however, there is mounting concern that this scientific progress is not being shared equitably by all segments of the U.S. population. There is underrepresentation of members of racial/ethnic groups in cancer clinical trials, which suggests that participation may be a critical issue. Unfortunately, little is known or documented about these groups' participation in clinical trials. This paper discusses racial/ethnic groups' views and opinions about clinical trial participation. Diagnostic research was conducted as a beginning phase to investigate this new area of research. African Americans, Hispanics, and Native Americans in three Buffalo, New York, communities were selected as study subjects. Data were collected via telephone surveys. Qualitative methods were employed for data analysis and reporting. Findings showed that study subjects knew little about cancer clinical trials and basically had no opportunity to participate. They believed that participation in clinical trials could be beneficial. In each of the three groups, however, there were cultural factors believed to influence participation. A primary concern was "mistrust of white people" and the feeling of being treated like "guinea pigs." Based on study findings, it was evident that recruitment for improving participation requires strategic planning that involves participants representative of the study population. To yield results, the plan should be tailored to the target group, presented as a credible study, designed to reflect trust in the medical care team, and implemented through a continuous educational process.

A data grid for imaging-based clinical trials

Science.gov (United States)

Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

2007-03-01

Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

Judicial Functions in the Criminal Trial

Directory of Open Access Journals (Sweden)

Constantin Tănase

2014-05-01

Full Text Available The separation of judicial functions falls, indisputably, in the news gallery of the Romanian criminal trial current rules. The previous Criminal Procedure Code, namely that of 1968, as well as the older ones, hadn‟t enrolled in their content such a principle. However, the doctrine identified, under mentioned legal regulations, the existence of distinct procedural functions and their need to separate, in the idea of genuine criminal justice accomplishment. These procedural functions were: the indictment function (or charges, the defense function the trial function. In the new code, this principle proclaims the existence of four judicial functions that aim the efficiency and speed of the criminal trial, but also guarantee the presumption of innocence, equal opportunity of parties, protection of rights and fundamental freedoms. This research try to explain this principle and its connections with other institutions of the criminal trial.

Protocol for: Sheffield Obesity Trial (SHOT: A randomised controlled trial of exercise therapy and mental health outcomes in obese adolescents [ISRCNT83888112

Directory of Open Access Journals (Sweden)

Wright Neil P

2005-10-01

Full Text Available Abstract Background While obesity is known to have many physiological consequences, the psychopathology of this condition has not featured prominently in the literature. Cross-sectional studies have indicated that obese children have increased odds of experiencing poor quality of life and mental health. However, very limited trial evidence has examined the efficacy of exercise therapy for enhancing mental health outcomes in obese children, and the Sheffield Obesity Trial (SHOT will provide evidence of the efficacy of supervised exercise therapy in obese young people aged 11–16 years versus usual care and an attention-control intervention. Method/design SHOT is a randomised controlled trial where obese young people are randomised to receive; (1 exercise therapy, (2 attention-control intervention (involving body-conditioning exercises and games that do not involve aerobic activity, or (3 usual care. The exercise therapy and attention-control sessions will take place three times per week for eight weeks and a six-week home programme will follow this. Ninety adolescents aged between 11–16 years referred from a children's hospital for evaluation of obesity or via community advertisements will need to complete the study. Participants will be recruited according to the following criteria: (1 clinically obese and aged 11–16 years (Body Mass Index Centile > 98th UK standard (2 no medical condition that would restrict ability to be active three times per week for eight weeks and (3 not diagnosed with insulin dependent diabetes or receiving oral steroids. Assessments of outcomes will take place at baseline, as well as four (intervention midpoint and eight weeks (end of intervention from baseline. Participants will be reassessed on outcome measures five and seven months from baseline. The primary endpoint is physical self-perceptions. Secondary outcomes include physical activity, self-perceptions, depression, affect, aerobic fitness and BMI.

From randomised trials to rational practice.

Science.gov (United States)

van Gijn, J

2005-01-01

From the age of Enlightenment onwards, philosophical thinking has become increasingly influenced by empiricism: observations lead to theories, but experiments are needed to put the reasoning to the test. However, it was not until the middle of the 20th century that well-designed experiments were at last introduced in medical treatment, in the form of randomised controlled clinical trials. This design is now standard in medicine, but in everyday practice a multitude of management decisions must still be taken without good evidence. There are several reasons for this: there may not be a trial at all or only a single trial; trial results may be equivocal; patients may be different from those enrolled in trials; new procedures require practice, or a trial may not be feasible. 'Logical reasoning', with all its fallacies, is still required - not only to fill the gaps in empirical knowledge but also to interpret existing evidence and to plan new trials. In fact, the generation of new knowledge is a continuous, cyclical process in which newly gained insights in pathophysiology give rise to new therapeutic experiments, the results of which generate fresh hypotheses, and so on. Compassion, curiosity and doubt are the essential forces that keep the cycle moving. Conversely, the progress is slowed down by present-day legalism, which distorts investigator accountability and patient autonomy. Copyright (c) 2005 S. Karger AG, Basel.

Balneotherapy in rheumatic diseases--an overview of novel and known aspects.

Science.gov (United States)

Lange, U; Müller-Ladner, U; Schmidt, K L

2006-04-01

Balneotherapeutic applications to treat rheumatic diseases have a long-term tradition and are based on established scientific principles, and the majority of rheumatic diseases most frequently include balneotherapy. However, as other therapeutic strategies, balneological interventions require scientific proof of their effect and efficacy. Notably, recent studies providing evidence of the thermic and chemical effects on the immune system and cytokine milieu have enforced the revival of the traditional balneological interventions. This review provides an overview of the known as well as the novel aspects of balneotherapy and their clinical relevance in the treatment of rheumatic diseases.

Novel roles for well-known players: from tobacco mosaic virus pests to enzymatically active assemblies.

Science.gov (United States)

Koch, Claudia; Eber, Fabian J; Azucena, Carlos; Förste, Alexander; Walheim, Stefan; Schimmel, Thomas; Bittner, Alexander M; Jeske, Holger; Gliemann, Hartmut; Eiben, Sabine; Geiger, Fania C; Wege, Christina

2016-01-01

The rod-shaped nanoparticles of the widespread plant pathogen tobacco mosaic virus (TMV) have been a matter of intense debates and cutting-edge research for more than a hundred years. During the late 19th century, their behavior in filtration tests applied to the agent causing the 'plant mosaic disease' eventually led to the discrimination of viruses from bacteria. Thereafter, they promoted the development of biophysical cornerstone techniques such as electron microscopy and ultracentrifugation. Since the 1950s, the robust, helically arranged nucleoprotein complexes consisting of a single RNA and more than 2100 identical coat protein subunits have enabled molecular studies which have pioneered the understanding of viral replication and self-assembly, and elucidated major aspects of virus-host interplay, which can lead to agronomically relevant diseases. However, during the last decades, TMV has acquired a new reputation as a well-defined high-yield nanotemplate with multivalent protein surfaces, allowing for an ordered high-density presentation of multiple active molecules or synthetic compounds. Amino acid side chains exposed on the viral coat may be tailored genetically or biochemically to meet the demands for selective conjugation reactions, or to directly engineer novel functionality on TMV-derived nanosticks. The natural TMV size (length: 300 nm) in combination with functional ligands such as peptides, enzymes, dyes, drugs or inorganic materials is advantageous for applications ranging from biomedical imaging and therapy approaches over surface enlargement of battery electrodes to the immobilization of enzymes. TMV building blocks are also amenable to external control of in vitro assembly and re-organization into technically expedient new shapes or arrays, which bears a unique potential for the development of 'smart' functional 3D structures. Among those, materials designed for enzyme-based biodetection layouts, which are routinely applied, e.g., for

Novel roles for well-known players: from tobacco mosaic virus pests to enzymatically active assemblies

Directory of Open Access Journals (Sweden)

Claudia Koch

2016-04-01

Full Text Available The rod-shaped nanoparticles of the widespread plant pathogen tobacco mosaic virus (TMV have been a matter of intense debates and cutting-edge research for more than a hundred years. During the late 19th century, their behavior in filtration tests applied to the agent causing the 'plant mosaic disease' eventually led to the discrimination of viruses from bacteria. Thereafter, they promoted the development of biophysical cornerstone techniques such as electron microscopy and ultracentrifugation. Since the 1950s, the robust, helically arranged nucleoprotein complexes consisting of a single RNA and more than 2100 identical coat protein subunits have enabled molecular studies which have pioneered the understanding of viral replication and self-assembly, and elucidated major aspects of virus–host interplay, which can lead to agronomically relevant diseases. However, during the last decades, TMV has acquired a new reputation as a well-defined high-yield nanotemplate with multivalent protein surfaces, allowing for an ordered high-density presentation of multiple active molecules or synthetic compounds. Amino acid side chains exposed on the viral coat may be tailored genetically or biochemically to meet the demands for selective conjugation reactions, or to directly engineer novel functionality on TMV-derived nanosticks. The natural TMV size (length: 300 nm in combination with functional ligands such as peptides, enzymes, dyes, drugs or inorganic materials is advantageous for applications ranging from biomedical imaging and therapy approaches over surface enlargement of battery electrodes to the immobilization of enzymes. TMV building blocks are also amenable to external control of in vitro assembly and re-organization into technically expedient new shapes or arrays, which bears a unique potential for the development of 'smart' functional 3D structures. Among those, materials designed for enzyme-based biodetection layouts, which are routinely applied

Does physical activity impact on presenteeism and other indicators of workplace well-being?

Science.gov (United States)

Brown, Helen E; Gilson, Nicholas D; Burton, Nicola W; Brown, Wendy J

2011-03-01

The term 'presenteeism' is a relatively new concept in workplace health, and has come to signify being at work despite poor health and performing below par. Presenteeism, which is potentially critical to employers, has been associated with a range of psychosocial outcome measures, such as poor mental health and employee well-being. Physical activity is a potential strategy for reducing presenteeism, and for improving the mental health of employees. This article reviews evidence on the relationships between physical activity and employee well-being and presenteeism in the workplace, and identifies directions for research in an emerging field. Electronic and manual literature searches were used to identify 20 articles that met the inclusion criteria. These included 13 intervention trials (8 randomized controlled trials, 5 comparison trials) and 7 observational studies (3 cohort, 4 cross-sectional). Outcome measures were grouped into 'workplace well-being', 'psychosocial well-being' and 'physical well-being'. Studies measured a wide variety of outcomes, with absenteeism being the most commonly assessed. Evidence indicated a positive association between physical activity and psychosocial health in employees, particularly for quality of life and emotional well-being. However, findings were inconclusive as to the role of physical activity in promoting workplace well-being. Only one study reported on presenteeism, with mixed evidence for outcomes. This article indicates that physical activity and employee psychosocial health are positively related, but there is limited evidence of a relationship between physical activity and presenteeism. A standardized definition of presenteeism and an appropriate evaluation tool are key research priorities if the complex relationships between physical activity and workplace well-being are to be better understood. © 2011 Adis Data Information BV. All rights reserved.

Recent clinical trials in valvular heart disease.

Science.gov (United States)

Kiss, Daniel; Anwaruddin, Saif

2017-07-01

With widespread adoption of transcatheter aortic valve replacement, there has been a change in the approach to management of valvular heart disease. New interest has taken hold in transcatheter therapies for valvular heart disease, as well as research into pathophysiology and progression of disease. Additionally, several key trials have further refined our understanding of surgical management of valvular heart disease. This review will elucidate recent clinical trial data leading to changes in practice. There have been several landmark trials expanding the indications for transcatheter aortic valve replacement. Additionally, although still early, trials are beginning to demonstrate the feasibility and safety of transcatheter mitral valves. Options for transcatheter management of right-sided valvular disease continue to evolve, and these are areas of active investigation. The emergence of novel therapies for valvular heart disease has expanded the management options available, allowing physicians to better individualize treatment of patients with valvular heart disease. This review will focus on the recent (within 2 years) trials in this field of interest.

Gaussian cloning of coherent states with known phases

International Nuclear Information System (INIS)

Alexanian, Moorad

2006-01-01

The fidelity for cloning coherent states is improved over that provided by optimal Gaussian and non-Gaussian cloners for the subset of coherent states that are prepared with known phases. Gaussian quantum cloning duplicates all coherent states with an optimal fidelity of 2/3. Non-Gaussian cloners give optimal single-clone fidelity for a symmetric 1-to-2 cloner of 0.6826. Coherent states that have known phases can be cloned with a fidelity of 4/5. The latter is realized by a combination of two beam splitters and a four-wave mixer operated in the nonlinear regime, all of which are realized by interaction Hamiltonians that are quadratic in the photon operators. Therefore, the known Gaussian devices for cloning coherent states are extended when cloning coherent states with known phases by considering a nonbalanced beam splitter at the input side of the amplifier

Clinical Trials

Medline Plus

Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

Improving outcomes of preschool language delay in the community: protocol for the Language for Learning randomised controlled trial

Directory of Open Access Journals (Sweden)

Wake Melissa

2012-07-01

yet tailored approach for each child, with a focus on specific language domains known to be associated with later language and literacy. The trial responds to identified evidence gaps, has outcomes of direct relevance to families and the community, includes a well-developed economic analysis, and has the potential to improve long-term consequences of early language delay within a public health framework. Trial registration Current Controlled Trials ISRCTN03981121.

Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial.

Science.gov (United States)

Nascimento, L S; Santos, A C; Lucena, Jms; Silva, Lgo; Almeida, Aem; Brasileiro-Santos, M S

2017-06-02

Resistant hypertension is a specific condition that affects approximately 10% of subjects with hypertension, and is characterized by persistently high blood pressure levels even using therapy of three or more antihypertensive agents or with blood pressure control using therapy with four or more antihypertensive agents. Changes in lifestyle, such as physical exercise, are indicated for controlling blood pressure. However, investigating studies about this therapy in individuals with resistant hypertension are few. This is a randomized controlled clinical trial. Forty-eight patients with resistant hypertension will be submitted to perform four short-term interventions: aerobic exercise sessions (mild-, moderate- and high-intensity) and control session, in random order and on separate days. After the short-term sessions, the patients will be randomly allocated into four groups for 8 weeks of follow-up: mild-, moderate- and high-intensity aerobic exercise, and a control group. The primary outcome is the occurrence of blood pressure reduction (office and ambulatory analysis, and acute and chronic effects). Secondary outcomes are autonomic and hemodynamic mechanisms: cardiac and vasomotor autonomic modulation, spontaneous baroreflex sensitivity, forearm blood flow and vascular resistance. The importance of exercise for hypertension has been known for decades, but little is known about the effects on patients with resistant hypertension. This study will help to understand whether different aerobic exercise intensities can induce different responses, as well as by what mechanisms adjustments in blood pressure levels may occur. ClinicalTrials.gov, ID: NCT02670681 . Registered on 28 January 2016 (first version); Brazilian Registry Platform Clinical Trials: protocol RBR-5q24zh . Registered on 24 June 2015.

Psychosocial effects of workplace physical exercise among workers with chronic pain:Randomized controlled trial

OpenAIRE

Andersen, Lars L.; Persson, Roger; Jakobsen, Markus D.; Sundstrup, Emil

2017-01-01

Abstract While workplace physical exercise can help manage musculoskeletal disorders, less is known about psychosocial effects of such interventions. This aim of this study was to investigate the effect of workplace physical exercise on psychosocial factors among workers with chronic musculoskeletal pain. The trial design was a 2-armed parallel-group randomized controlled trial with allocation concealment. A total of 66 slaughterhouse workers (51 men and 15 women, mean age 45 years [standard ...

Searching for cures: Inner-city and rural patients' awareness and perceptions of cancer clinical trials

Directory of Open Access Journals (Sweden)

Mugur Geana

2017-03-01

Full Text Available Fewer than 5% of cancer patients participate in clinical trials, making it challenging to test new therapies or interventions for cancer. Even within that small number, patients living in inner-city and rural areas are underrepresented in clinical trials. This study explores cancer patients' awareness and perceptions of cancer clinical trials, as well as their perceptions of patient-provider interactions related to discussing cancer clinical trials in order to improve accrual in cancer clinical trials. Interviews with 66 former and current in inner-city and rural cancer patients revealed a lack of awareness and understanding about clinical trials, as well as misconceptions about what clinical trials entail. Findings also revealed that commercials and television shows play a prominent role in forming inner-city and rural patients' attitudes and/or misconceptions about clinical trials. However, rural patients were more likely to hold unfavorable views about clinical trials than inner-city patients. Patient-provider discussions emerged as being crucial for increasing awareness of clinical trials among patients and recruiting them to trials. Findings from this study will inform communication strategies to enhance recruitment to cancer clinical trials by increasing awareness and countering misconceptions about clinical trials.

Trial-by-trial variations in subjective attentional state are reflected in ongoing prestimulus EEG alpha oscillations

Directory of Open Access Journals (Sweden)

James Stuart Peter Macdonald

2011-05-01

Full Text Available Parieto-occipital EEG alpha power and subjective reports of attentional state are both associated with visual attention and awareness, but little is currently known about the relationship between these two measures. Here, we bring together these two literatures to explore the relationship between alpha activity and participants’ introspective judgements of attentional state as each varied from trial to trial during performance of a visual detection task. We collected participants’ subjective ratings of perceptual decision confidence and attentional state on continuous scales on each trial of a rapid serial visual presentation (RSVP detection task while recording EEG. We found that confidence and attentional state ratings were largely uncorrelated with each other, but both were strongly associated with task performance and post-stimulus decision-related EEG activity. Crucially, attentional state ratings were also negatively associated with prestimulus EEG alpha power. Attesting to the robustness of this association, we were able to classify attentional state ratings via prestimulus alpha power on a single-trial basis. Moreover, when we repeated these analyses after smoothing the time series of attentional state ratings and alpha power with increasingly large sliding windows, both the correlations and classification performance improved considerably, with the peaks occurring at a sliding window size of approximately seven minutes worth of trials. Our results therefore suggest that slow fluctuations in attentional state in the order of minutes are reflected in spontaneous alpha power. Since these subjective attentional state ratings were associated with objective measures of both behaviour and neural activity, we suggest that they provide a simple and effective estimate of task engagement that could prove useful in operational settings that require human operators to maintain a sustained focus of visual attention.

Community based physiotherapeutic exercise in COPD self-management: a randomised controlled trial.

NARCIS (Netherlands)

Effing, T.; Zielhuis, G.A.; Kerstjens, H.; Valk, P. van der; Palen, J.A.M. van der

2011-01-01

Little is known about effects of community-based physiotherapeutic exercise programmes incorporated in COPD self-management programmes. In a randomised trial, the effect of such a programme (COPE-active) on exercise capacity and various secondary outcomes including daily activity as a marker of

Community based psysiotherapeutic exercise in COPD self-management: A randomised controlled trial

NARCIS (Netherlands)

Effing, T.W.; Zielhuis, Gerhard; Kerstjens, Huib; van der Valk, Paul; van der Palen, Jacobus Adrianus Maria

2011-01-01

Little is known about effects of community-based physiotherapeutic exercise programmes incorporated in COPD self-management programmes. In a randomised trial, the effect of such a programme (COPE-active) on exercise capacity and various secondary outcomes including daily activity as a marker of

Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte Oncology Network

Directory of Open Access Journals (Sweden)

Ciuffreda Libero

2009-11-01

Full Text Available Abstract Background Well-differentiated neuroendocrine carcinomas are highly vascularized and may be sensitive to drugs administered on a metronomic schedule that has shown antiangiogenic properties. A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU infusion plus long-acting release (LAR octreotide in patients with neuroendocrine carcinoma. Methods Twenty-nine patients with metastatic or locally advanced well-differentiated neuroendocrine carcinoma were treated with protracted 5FU intravenous infusion (200 mg/m2 daily plus LAR octreotide (20 mg monthly. Patients were followed for toxicity, objective response, symptomatic and biochemical response, time to progression and survival. Results Assessment by Response Evaluation Criteria in Solid Tumors (RECIST criteria showed partial response in 7 (24.1%, stable disease in 20 (69.0%, and disease progression in 2 patients. Response did not significantly differ when patients were stratified by primary tumor site and proliferative activity. A biochemical (chromogranin A response was observed in 12/25 assessable patients (48.0%; symptom relief was obtained in 9/15 symptomatic patients (60.0%. There was non significant decrease in circulating vascular epithelial growth factor (VEGF over time. Median time to progression was 22.6 months (range, 2.7-68.5; median overall survival was not reached yet. Toxicity was mild and manageable. Conclusion Continuous/metronomic 5FU infusion plus LAR octreotide is well tolerated and shows activity in patients with well-differentiated neuroendocrine carcinoma. The potential synergism between metronomic chemotherapy and antiangiogenic drugs provides a rationale for exploring this association in the future. Trial registration NCT00953394

Automated classification of eligibility criteria in clinical trials to facilitate patient-trial matching for specific patient populations.

Science.gov (United States)

Zhang, Kevin; Demner-Fushman, Dina

2017-07-01

To develop automated classification methods for eligibility criteria in ClinicalTrials.gov to facilitate patient-trial matching for specific populations such as persons living with HIV or pregnant women. We annotated 891 interventional cancer trials from ClinicalTrials.gov based on their eligibility for human immunodeficiency virus (HIV)-positive patients using their eligibility criteria. These annotations were used to develop classifiers based on regular expressions and machine learning (ML). After evaluating classification of cancer trials for eligibility of HIV-positive patients, we sought to evaluate the generalizability of our approach to more general diseases and conditions. We annotated the eligibility criteria for 1570 of the most recent interventional trials from ClinicalTrials.gov for HIV-positive and pregnancy eligibility, and the classifiers were retrained and reevaluated using these data. On the cancer-HIV dataset, the baseline regex model, the bag-of-words ML classifier, and the ML classifier with named entity recognition (NER) achieved macro-averaged F2 scores of 0.77, 0.87, and 0.87, respectively; the addition of NER did not result in a significant performance improvement. On the general dataset, ML + NER achieved macro-averaged F2 scores of 0.91 and 0.85 for HIV and pregnancy, respectively. The eligibility status of specific patient populations, such as persons living with HIV and pregnant women, for clinical trials is of interest to both patients and clinicians. We show that it is feasible to develop a high-performing, automated trial classification system for eligibility status that can be integrated into consumer-facing search engines as well as patient-trial matching systems. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the US.

Marketing and clinical trials: a case study

OpenAIRE

Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

2007-01-01

Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

School Staff Perceptions of Well-Being and Experience of an Intervention to Promote Well-Being

Science.gov (United States)

Sharrocks, Louise

2014-01-01

An intervention was carried out with primary school staff to promote well-being with weekly sessions of a project which became known as Chill and Chat. Data were gathered via questionnaires completed before and after the project and from three focus groups (before, during and after the intervention), and were analysed using thematic analysis.…

Clinical Trials

Medline Plus

Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

The intriguing enhancement of chloroperoxidase mediated one-electron oxidations by azide, a known active-site ligand

International Nuclear Information System (INIS)

Andrew, Daniel; Hager, Lowell; Manoj, Kelath Murali

2011-01-01

Highlights: ► Azide is a well known heme–enzyme active site ligand and inhibitor. ► Herein, azide is reported to enhance a set of heme–enzyme mediated reactions. ► This effect is disconnected from native enzyme–azide binding. ► Azide could enhance heme–enzyme reactions via a newly proposed mechanism. ► Azide contained in reagents could impact reaction outcomes in redox biochemistry. -- Abstract: Azide is a well-known inhibitor of heme–enzymes. Herein, we report the counter-intuitive observation that at some concentration regimes, incorporation of azide in the reaction medium enhances chloroperoxidase (CPO, a heme–enzyme) mediated one-electron abstractions from several substrates. A diffusible azidyl radical based mechanism is proposed for explaining the phenomenon. Further, it is projected that the finding could have significant impact on routine in situ or in vitro biochemistry studies involving heme–enzyme systems and azide.

Study of neurontin: titrate to effect, profile of safety (STEPS) trial: a narrative account of a gabapentin seeding trial.

Science.gov (United States)

Krumholz, Samuel D; Egilman, David S; Ross, Joseph S

2011-06-27

Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail. We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) produced during the Neurontin marketing, sales practices, and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert, most which were created between 1990 and 2009. Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial in order to identify key themes related to the trial's conduct and determine the extent of marketing involvement in its planning and implementation. Documents demonstrated that STEPS was a seeding trial posing as a legitimate scientific study. Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company's marketing plans. Documents demonstrated that at least 2 external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association. None of these findings were reported in 2 published articles. The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.

Adaptive Clinical Trials: Advantages and Disadvantages of Various Adaptive Design Elements.

Science.gov (United States)

Korn, Edward L; Freidlin, Boris

2017-06-01

There is a wide range of adaptive elements of clinical trial design (some old and some new), with differing advantages and disadvantages. Classical interim monitoring, which adapts the design based on early evidence of superiority or futility of a treatment arm, has long been known to be extremely useful. A more recent application of interim monitoring is in the use of phase II/III designs, which can be very effective (especially in the setting of multiple experimental treatments and a reliable intermediate end point) but do have the cost of having to commit earlier to the phase III question than if separate phase II and phase III trials were performed. Outcome-adaptive randomization is an older technique that has recently regained attention; it increases trial complexity and duration without offering substantial benefits to the patients in the trial. The use of adaptive trials with biomarkers is new and has great potential for efficiently identifying patients who will be helped most by specific treatments. Master protocols in which trial arms and treatment questions are added to an ongoing trial can be especially efficient in the biomarker setting, where patients are screened for entry into different subtrials based on evolving knowledge about targeted therapies. A discussion of three recent adaptive clinical trials (BATTLE-2, I-SPY 2, and FOCUS4) highlights the issues. Published by Oxford University Press 2017. This work is written by US Government employees and is in the public domain in the US.

Gender differences in clinical registration trials: is there a real problem?

Science.gov (United States)

Labots, Geert; Jones, Aubrey; de Visser, Saco J.; Burggraaf, Jacobus

2018-01-01

Aims Several studies have reported the under‐representation of women in clinical trials, thereby challenging the external validity of the benefit/risk assessments of launched drugs. Our aim was to determine the extent to which women have been included in clinical trials used for drug registration and to analyse the fraction of women participating in phases I, II and III. Methods We conducted cross‐sectional, structured research into publicly available registration dossiers of Food and Drug Administration (FDA)‐approved drugs that are prescribed frequently. Furthermore, we analysed compounds with high hepatic clearance and a known gender‐related difference in drug response. In a sensitivity analysis, we compared figures with US disease prevalence data. Results For 38 of the initial 137 drugs (28%), sufficient data were reported and publicly available. For these drugs, 185 479 trial participants were included, of whom 47% were female and 44% were male; gender was not reported for 9% of participants. However, the number of female participants varied with the phase of the trial, with 22% females in phase I trials vs. 48% and 49%, respectively, in phase II and III trials. When compared with US disease prevalence data, 10 drugs (26%) had a greater than 20% difference between the proportion of females affected with the disease compared with representation in clinical trials. Conclusions From these publicly available data, there was no evidence of any systematic under‐representation of women in clinical trials. PMID:29293280

One-stage individual participant data meta-analysis models: estimation of treatment-covariate interactions must avoid ecological bias by separating out within-trial and across-trial information.

Science.gov (United States)

Hua, Hairui; Burke, Danielle L; Crowther, Michael J; Ensor, Joie; Tudur Smith, Catrin; Riley, Richard D

2017-02-28

Stratified medicine utilizes individual-level covariates that are associated with a differential treatment effect, also known as treatment-covariate interactions. When multiple trials are available, meta-analysis is used to help detect true treatment-covariate interactions by combining their data. Meta-regression of trial-level information is prone to low power and ecological bias, and therefore, individual participant data (IPD) meta-analyses are preferable to examine interactions utilizing individual-level information. However, one-stage IPD models are often wrongly specified, such that interactions are based on amalgamating within- and across-trial information. We compare, through simulations and an applied example, fixed-effect and random-effects models for a one-stage IPD meta-analysis of time-to-event data where the goal is to estimate a treatment-covariate interaction. We show that it is crucial to centre patient-level covariates by their mean value in each trial, in order to separate out within-trial and across-trial information. Otherwise, bias and coverage of interaction estimates may be adversely affected, leading to potentially erroneous conclusions driven by ecological bias. We revisit an IPD meta-analysis of five epilepsy trials and examine age as a treatment effect modifier. The interaction is -0.011 (95% CI: -0.019 to -0.003; p = 0.004), and thus highly significant, when amalgamating within-trial and across-trial information. However, when separating within-trial from across-trial information, the interaction is -0.007 (95% CI: -0.019 to 0.005; p = 0.22), and thus its magnitude and statistical significance are greatly reduced. We recommend that meta-analysts should only use within-trial information to examine individual predictors of treatment effect and that one-stage IPD models should separate within-trial from across-trial information to avoid ecological bias. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd

A Mismatch EndoNuclease Array-Based Methodology (MENA) for Identifying Known SNPs or Novel Point Mutations.

Science.gov (United States)

Comeron, Josep M; Reed, Jordan; Christie, Matthew; Jacobs, Julia S; Dierdorff, Jason; Eberl, Daniel F; Manak, J Robert

2016-04-05

Accurate and rapid identification or confirmation of single nucleotide polymorphisms (SNPs), point mutations and other human genomic variation facilitates understanding the genetic basis of disease. We have developed a new methodology (called MENA (Mismatch EndoNuclease Array)) pairing DNA mismatch endonuclease enzymology with tiling microarray hybridization in order to genotype both known point mutations (such as SNPs) as well as identify previously undiscovered point mutations and small indels. We show that our assay can rapidly genotype known SNPs in a human genomic DNA sample with 99% accuracy, in addition to identifying novel point mutations and small indels with a false discovery rate as low as 10%. Our technology provides a platform for a variety of applications, including: (1) genotyping known SNPs as well as confirming newly discovered SNPs from whole genome sequencing analyses; (2) identifying novel point mutations and indels in any genomic region from any organism for which genome sequence information is available; and (3) screening panels of genes associated with particular diseases and disorders in patient samples to identify causative mutations. As a proof of principle for using MENA to discover novel mutations, we report identification of a novel allele of the beethoven (btv) gene in Drosophila, which encodes a ciliary cytoplasmic dynein motor protein important for auditory mechanosensation.

Discovery of Nearest Known Brown Dwarf

Science.gov (United States)

2003-01-01

Bright Southern Star Epsilon Indi Has Cool, Substellar Companion [1] Summary A team of European astronomers [2] has discovered a Brown Dwarf object (a 'failed' star) less than 12 light-years from the Sun. It is the nearest yet known. Now designated Epsilon Indi B, it is a companion to a well-known bright star in the southern sky, Epsilon Indi (now "Epsilon Indi A"), previously thought to be single. The binary system is one of the twenty nearest stellar systems to the Sun. The brown dwarf was discovered from the comparatively rapid motion across the sky which it shares with its brighter companion : the pair move a full lunar diameter in less than 400 years. It was first identified using digitised archival photographic plates from the SuperCOSMOS Sky Surveys (SSS) and confirmed using data from the Two Micron All Sky Survey (2MASS). Follow-up observations with the near-infrared sensitive SOFI instrument on the ESO 3.5-m New Technology Telescope (NTT) at the La Silla Observatory confirmed its nature and has allowed measurements of its physical properties. Epsilon Indi B has a mass just 45 times that of Jupiter, the largest planet in the Solar System, and a surface temperature of only 1000 °C. It belongs to the so-called 'T dwarf' category of objects which straddle the domain between stars and giant planets. Epsilon Indi B is the nearest and brightest T dwarf known. Future studies of the new object promise to provide astronomers with important new clues as to the formation and evolution of these exotic celestial bodies, at the same time yielding interesting insights into the border zone between planets and stars. TINY MOVING NEEDLES IN GIANT HAYSTACKS ESO PR Photo 03a/03 ESO PR Photo 03a/03 [Preview - JPEG: 400 x 605 pix - 92k [Normal - JPEG: 1200 x 1815 pix - 1.0M] Caption: PR Photo 03a/03 shows Epsilon Indi A (the bright star at far right) and its newly discovered brown dwarf companion Epsilon Indi B (circled). The upper image comes from one of the SuperCOSMOS Sky

New Mexico Known Mineral Deposit Areas

Data.gov (United States)

Earth Data Analysis Center, University of New Mexico — This dataset contains all Known Mineral Deposit Areas in the state of New Mexico. It is in a vector digital structure digitized from a 1:500,000 scale map of the...

Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Heger Ulrike

2011-11-01

Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

Differences in Investigator-Initiated Trials between Japan and Other Countries: Analyses of Clinical Trials Sponsored by Academia and Government in the ClinicalTrials.gov Registry and in the Three Japanese Registries.

Directory of Open Access Journals (Sweden)

Tatsuya Ito

Full Text Available Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs. In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs.The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries.Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data.New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants.There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan.

A commentary on transdermal drug delivery systems in clinical trials.

Science.gov (United States)

Watkinson, Adam C

2013-09-01

The number of drugs available as marketed transdermal products is limited to those that exhibit the correct physicochemical and pharmacokinetic properties that enable their effective delivery across the skin. In this respect, there are less than 20 drugs that are currently marketed in the US and EU as products that deliver systemic levels of their active ingredients. An analysis of clinical trials conducted in the transdermal sector shows a similar picture with only nine drugs accounting for approximately 80% of all transdermal clinical trials listed on ClinicalTrials.gov. Those drugs for which there are very few transdermal trials listed consist mostly of molecules that are inherently unsuitable for transdermal delivery and serve as a clear warning to drug developers that the science that governs transdermal drug delivery is well reflected by the successes and failures of drugs in development as well as those that make it to the market. Copyright © 2013 Wiley Periodicals, Inc.

Proactive palliative care for patients with COPD (PROLONG): a pragmatic cluster controlled trial

NARCIS (Netherlands)

Duenk, R.G.; Verhagen, C.A.; Bronkhorst, E.M.; Mierlo, P. van; Broeders, M.E.A.C.; Collard, S.M.; Dekhuijzen, P.N.R.; Vissers, K.C.P.; Heijdra, Y.F.; Engels, Y.

2017-01-01

BACKGROUND AND AIM: Patients with advanced chronic obstructive pulmonary disease (COPD) have poor quality of life. The aim of this study was to assess the effects of proactive palliative care on the well-being of these patients. TRIAL REGISTRATION: This trial is registered with the Netherlands Trial

Promoting social inclusion in schools: a group-randomized trial of effects on student health risk behavior and well-being.

Science.gov (United States)

Patton, George C; Bond, Lyndal; Carlin, John B; Thomas, Lyndal; Butler, Helen; Glover, Sara; Catalano, Richard; Bowes, Glenn

2006-09-01

We sought to test the efficacy of an intervention that was designed to promote social inclusion and commitment to education, in reducing among students health risk behaviors and improving emotional well-being. The design was a cluster-randomized trial in 25 secondary schools in Victoria, Australia. The subjects were 8th-grade students (aged 13 to 14 y) in 1997 (n=2545) and subsequent 8th-grade students in 1999 (n=2586) and 2001 (n=2463). The main outcomes were recent substance use, antisocial behavior, initiation of sexual intercourse, and depressive symptoms. At 4-year follow-up, the prevalence of marked health risk behaviors was approximately 20% in schools in the comparison group and 15% in schools in the intervention group, an overall reduction of 25%. In ordinal logistic regression models a protective effect of intervention was found for a composite measure of health risk behaviors in unadjusted models (odds ratio [OR]= 0.69; 95% confidence interval [CI]= 0.50, 0.95) and adjusted models (OR= 0.71; CI =0.52, 0.97) for potential confounders. There was no evidence of a reduction in depressive symptoms. The study provides support for prevention strategies in schools that move beyond health education to promoting positive social environments.

Knowns and unknowns on burden of disease due to chemicals: a systematic review

Directory of Open Access Journals (Sweden)

Bertollini Roberto

2011-01-01

Full Text Available Abstract Background Continuous exposure to many chemicals, including through air, water, food, or other media and products results in health impacts which have been well assessed, however little is known about the total disease burden related to chemicals. This is important to know for overall policy actions and priorities. In this article the known burden related to selected chemicals or their mixtures, main data gaps, and the link to public health policy are reviewed. Methods A systematic review of the literature for global burden of disease estimates from chemicals was conducted. Global disease due to chemicals was estimated using standard methodology of the Global Burden of Disease. Results In total, 4.9 million deaths (8.3% of total and 86 million Disability-Adjusted Life Years (DALYs (5.7% of total were attributable to environmental exposure and management of selected chemicals in 2004. The largest contributors include indoor smoke from solid fuel use, outdoor air pollution and second-hand smoke, with 2.0, 1.2 and 0.6 million deaths annually. These are followed by occupational particulates, chemicals involved in acute poisonings, and pesticides involved in self-poisonings, with 375,000, 240,000 and 186,000 annual deaths, respectively. Conclusions The known burden due to chemicals is considerable. This information supports decision-making in programmes having a role to play in reducing human exposure to toxic chemicals. These figures present only a number of chemicals for which data are available, therefore, they are more likely an underestimate of the actual burden. Chemicals with known health effects, such as dioxins, cadmium, mercury or chronic exposure to pesticides could not be included in this article due to incomplete data and information. Effective public health interventions are known to manage chemicals and limit their public health impacts and should be implemented at national and international levels.

Knowns and unknowns on burden of disease due to chemicals: a systematic review

Science.gov (United States)

2011-01-01

Background Continuous exposure to many chemicals, including through air, water, food, or other media and products results in health impacts which have been well assessed, however little is known about the total disease burden related to chemicals. This is important to know for overall policy actions and priorities. In this article the known burden related to selected chemicals or their mixtures, main data gaps, and the link to public health policy are reviewed. Methods A systematic review of the literature for global burden of disease estimates from chemicals was conducted. Global disease due to chemicals was estimated using standard methodology of the Global Burden of Disease. Results In total, 4.9 million deaths (8.3% of total) and 86 million Disability-Adjusted Life Years (DALYs) (5.7% of total) were attributable to environmental exposure and management of selected chemicals in 2004. The largest contributors include indoor smoke from solid fuel use, outdoor air pollution and second-hand smoke, with 2.0, 1.2 and 0.6 million deaths annually. These are followed by occupational particulates, chemicals involved in acute poisonings, and pesticides involved in self-poisonings, with 375,000, 240,000 and 186,000 annual deaths, respectively. Conclusions The known burden due to chemicals is considerable. This information supports decision-making in programmes having a role to play in reducing human exposure to toxic chemicals. These figures present only a number of chemicals for which data are available, therefore, they are more likely an underestimate of the actual burden. Chemicals with known health effects, such as dioxins, cadmium, mercury or chronic exposure to pesticides could not be included in this article due to incomplete data and information. Effective public health interventions are known to manage chemicals and limit their public health impacts and should be implemented at national and international levels. PMID:21255392

Evaluation Using Sequential Trials Methods.

Science.gov (United States)

Cohen, Mark E.; Ralls, Stephen A.

1986-01-01

Although dental school faculty as well as practitioners are interested in evaluating products and procedures used in clinical practice, research design and statistical analysis can sometimes pose problems. Sequential trials methods provide an analytical structure that is both easy to use and statistically valid. (Author/MLW)

Recruitment barriers for prophylactic vaccine trials: A study in Belgium.

Science.gov (United States)

Harrington, Lauriane; Van Damme, Pierre; Vandermeulen, Corinne; Mali, Stéphanie

2017-12-04

Recruitment of volunteers is one of the main challenges in clinical trial management, and there is little information about recruitment barriers for preventative vaccine trials. We investigated both the recruitment barriers and recruitment strategies for preventive vaccine trials in Belgium. A 10 min survey was used as well as interviews of staff at all clinical trial sites in Belgium that regularly perform vaccine trials. We observed that there are successful recruitment strategies and few recruitment issues for trials involving healthy adults and those over 65 years old. However, challenges face the recruitment of paediatric populations, pregnant women, patients and the very elderly (over 85 years old). From these results, we identified three priority areas to increase recruitment for prophylactic vaccine trials in Belgium. These are: the lack of public knowledge about infectious diseases; the lack of resources of healthcare professionals to take part in clinical trials; and the burden to potential volunteers to take part in a trial. These were discussed with stakeholders and solutions were proposed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints

Science.gov (United States)

Renfro, Lindsay A.; Shi, Qian; Xue, Yuan; Li, Junlong; Shang, Hongwei; Sargent, Daniel J.

2014-01-01

Evaluation of candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogacy analyses on trial sub-units (e.g., centers within trials), thereby artificially increasing the trial-level sample size for feasibility of the multi-trial analysis. To date, the practical impact of treating trial sub-units (centers) identically to trials in multi-trial surrogacy analyses remains unexplored, and conditions under which this ad hoc solution may in fact be reasonable have not been identified. We perform a simulation study to identify such conditions, and demonstrate practical implications using a multi-trial dataset of patients with early stage colon cancer. PMID:25061255

Inferior parietal and right frontal contributions to trial-by-trial adaptations of attention to memory.

Science.gov (United States)

Kizilirmak, Jasmin M; Rösler, Frank; Bien, Siegfried; Khader, Patrick H

2015-07-21

The attention to memory theory (AtoM) proposes that the same brain regions might be involved in selective processing of perceived stimuli (selective attention) and memory representations (selective retrieval). Although this idea is compelling, given consistently found neural overlap between perceiving and remembering stimuli, recent comparisons brought evidence for overlap as well as considerable differences. Here, we present a paradigm that enables the investigation of the AtoM hypothesis from a novel perspective to gain further insight into the neural resources involved in AtoM. Selective attention in perception is often investigated as a control process that shows lingering effects on immediately following trials. Here, we employed a paradigm capable of modulating selective retrieval in a similarly dynamic manner as in such selective-attention paradigms by inducing trial-to-trial shifts between relevant and irrelevant memory representations as well as changes of the width of the internal focus on memory. We found evidence for an involvement of bilateral inferior parietal lobe and right inferior frontal gyrus in reorienting the attentional focus on previously accessed memory representations. Moreover, we could dissociate the right inferior from the parietal activation in separate contrasts, suggesting that the right inferior frontal gyrus plays a role in facilitating attentional reorienting to memory representations when competing representations have been activated in the preceding trial, potentially by resolving this competition. Our results support the AtoM theory, i.e. that ventral frontal and parietal regions are involved in automatic attentional reorienting in memory, and highlight the importance of further investigations of the overlap and differences between regions involved in internal (memory) and external (perceptual) attentional selection. Copyright © 2015 Elsevier B.V. All rights reserved.

Exploring Wellness Interventions in Progressive Multiple Sclerosis: an Evidence-Based Review.

Science.gov (United States)

Venasse, Myriam; Edwards, Thomas; Pilutti, Lara A

2018-04-10

There has been recent interest in the role of lifestyle and wellness-based approaches in the treatment and management of multiple sclerosis (MS). These approaches may be particularly relevant for patients with progressive MS, considering limited therapeutic options currently available. The purpose of this review is to examine the role of wellness-based interventions including exercise training, emotional well-being therapies, and dietary modification in patients with progressive MS. We conducted a literature search on the efficacy of wellness-based interventions in patients with progressive MS published between 1985 and July 2017. The level of evidence for each trial was evaluated using the American Academy of Neurology criteria. Overall, 21 articles reporting on 16 wellness-based interventions were identified: ten trials involved exercise training, three involved emotional wellness therapies, two involved dietary modification, and one was a combined wellness intervention. There is level C evidence (possibly effective; one class II study) for the efficacy of aerobic exercise training on cardiorespiratory fitness in patients with progressive MS. There is level B evidence (probably effective; one class I study) for the efficacy of mindfulness training on psychological distress, depression, anxiety, pain, and quality of life in patients with progressive MS. There is inadequate evidence (level U) for efficacy of dietary modification (one class III study and one class IV study) and combined wellness interventions involving exercise training, meditation, and dietary modification (one class IV study). High-quality research is needed to provide evidence-based recommendations for wellness behaviors and lifestyle change in patients with progressive MS.

The well-known unknown photographer Jaan Klõšeiko / Ellu Maar

Index Scriptorium Estoniae

Maar, Ellu, 1982-

2010-01-01

Graafik ja fotograaf Jaan Klõšeikost, kes on 45 aastat jäädvustanud kunsti- ja kultuurisündmusi. Galerii Vaal kodulehel ilmunud J. Klõšeiko fotoseeriatest (12), fotod valis ja saatesõnad kirjutas J. Klõšeiko

A 5-trial adjusting delay discounting task: Accurate discount rates in less than 60 seconds

Science.gov (United States)

Koffarnus, Mikhail N.; Bickel, Warren K.

2014-01-01

Individuals who discount delayed rewards at a high rate are more likely to engage in substance abuse, overeating, or problem gambling. Findings such as these suggest the value of methods to obtain an accurate and fast measurement of discount rate that can be easily deployed in variety of settings. In the present study, we developed and evaluated the 5-trial adjusting delay task, a novel method of obtaining discount rate in less than one minute. We hypothesized that discount rates from the 5-trial adjusting delay task would be similar and correlated with discount rates from a lengthier task we have used previously, and that four known effects relating to delay discounting would be replicable with this novel task. To test these hypotheses, the 5-trial adjusting delay task was administered to 111 college students six times to obtain discount rates for six different commodities, along with a lengthier adjusting amount discounting task. We found that discount rates were similar and correlated between the 5-trial adjusting delay task and the adjusting amount task. Each of the four known effects relating to delay discounting was replicated with the 5-trial adjusting delay task to varying degrees. First, discount rates were inversely correlated with amount. Second, discount rates between past and future outcomes were correlated. Third, discount rates were greater for consumable rewards than with money, although we did not control for amount in this comparison. Fourth, discount rates were lower when zero amounts opposing the chosen time point were explicitly described. Results indicate that the 5-trial adjusting delay task is a viable, rapid method to assess discount rate. PMID:24708144

A 5-trial adjusting delay discounting task: accurate discount rates in less than one minute.

Science.gov (United States)

Koffarnus, Mikhail N; Bickel, Warren K

2014-06-01

Individuals who discount delayed rewards at a high rate are more likely to engage in substance abuse, overeating, or problem gambling. Such findings suggest the value of methods to obtain an accurate and fast measurement of discount rate that can be easily deployed in variety of settings. In the present study, we developed and evaluated the 5-trial adjusting delay task, a novel method of obtaining a discount rate in less than 1 min. We hypothesized that discount rates from the 5-trial adjusting delay task would be similar and would correlate with discount rates from a lengthier task we have used previously, and that 4 known effects relating to delay discounting would be replicable with this novel task. To test these hypotheses, the 5-trial adjusting delay task was administered to 111 college students 6 times to obtain discount rates for 6 different commodities, along with a lengthier adjusting amount discounting task. We found that discount rates were similar and correlated between the 5-trial adjusting delay task and the adjusting amount task. Each of the 4 known effects relating to delay discounting was replicated with the 5-trial adjusting delay task to varying degrees. First, discount rates were inversely correlated with amount. Second, discount rates between past and future outcomes were correlated. Third, discount rates were greater for consumable rewards than with money, although we did not control for amount in this comparison. Fourth, discount rates were lower when $0 amounts opposing the chosen time point were explicitly described. Results indicate that the 5-trial adjusting delay task is a viable, rapid method to assess discount rate. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Feasibility of a randomised trial of a continuing medical education program in shared decision-making on the use of antibiotics for acute respiratory infections in primary care: the DECISION+ pilot trial

Directory of Open Access Journals (Sweden)

Laurier Claudine

2011-01-01

Full Text Available Abstract Background The misuse and limited effectiveness of antibiotics for acute respiratory infections (ARIs are well documented, and current approaches targeting physicians or patients to improve appropriate use have had limited effect. Shared decision-making could be a promising strategy to improve appropriate antibiotic use for ARIs, but very little is known about its implementation processes and outcomes in clinical settings. In this matter, pilot studies have played a key role in health science research over the past years in providing information for the planning, justification, and/or refinement of larger studies. The objective of our study was to assess the feasibility and acceptability of the study design, procedures, and intervention of the DECISION+ program, a continuing medical education program in shared decision-making among family physicians and their patients on the optimal use of antibiotics for treating ARIs in primary care. Methods A pilot clustered randomised trial was conducted. Family medicine groups (FMGs were randomly assigned, to either the DECISION+ program, which included three 3-hour workshops over a four- to six-month period, or a control group that had a delayed exposure to the program. Results Among 21 FMGs contacted, 5 (24% agreed to participate in the pilot study. A total of 39 family physicians (18 in the two experimental and 21 in the three control FMGs and their 544 patients consulting for an ARI were recruited. The proportion of recruited family physicians who participated in all three workshops was 46% (50% for the experimental group and 43% for the control group, and the overall mean level of satisfaction regarding the workshops was 94%. Conclusions This trial, while aiming to demonstrate the feasibility and acceptability of conducting a larger study, has identified important opportunities for improving the design of a definitive trial. This pilot trial is informative for researchers and clinicians

The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database

Science.gov (United States)

Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

2017-01-01

In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials. PMID:28042342

An electronic regulatory document management system for a clinical trial network.

Science.gov (United States)

Zhao, Wenle; Durkalski, Valerie; Pauls, Keith; Dillon, Catherine; Kim, Jaemyung; Kolk, Deneil; Silbergleit, Robert; Stevenson, Valerie; Palesch, Yuko

2010-01-01

A computerized regulatory document management system has been developed as a module in a comprehensive Clinical Trial Management System (CTMS) designed for an NIH-funded clinical trial network in order to more efficiently manage and track regulatory compliance. Within the network, several institutions and investigators are involved in multiple trials, and each trial has regulatory document requirements. Some of these documents are trial specific while others apply across multiple trials. The latter causes a possible redundancy in document collection and management. To address these and other related challenges, a central regulatory document management system was designed. This manuscript shares the design of the system as well as examples of it use in current studies. Copyright (c) 2009 Elsevier Inc. All rights reserved.

Clinical Trials

Medline Plus

Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

Clinical Trials

Medline Plus

Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

Clinical Trials

Medline Plus

Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

Clinical Trials

Medline Plus

Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

Clinical Trials

Medline Plus

Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

Clinical Trials

Medline Plus

Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

Clinical Trials

Medline Plus

Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

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

OpenAIRE

Videikaitė, Lina

2014-01-01

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

Forty-five years of schizophrenia trials in Italy: a survey

Directory of Open Access Journals (Sweden)

Purgato Marianna

2012-04-01

Full Text Available Abstract Background Well-designed and properly executed randomized controlled trials (RCTs provide the best evidence on the efficacy of healthcare interventions. Mental health has a strong tradition of using trial to evaluate treatments, but the translation of research to clinical practice is not always easy. Even well-conducted trials do not necessarily address the needs of every day care and trials can reflect local needs and the specific culture in which they are undertaken. Generalizing results to other contexts can become problematic but these trials may, nevertheless, be very helpful within their own context. Moreover, pathways for drug approval can be different depending on local regulatory agencies. Local trials are helpful for decision-making in the region from which they come, but should not be viewed in isolation. National quantity and quality of trials may vary across nations. The aim of this study is to quantify trialing activity in Italy from 1948 until 2009 and to describe characteristics of these trials. In addition, we evaluated change over time in three keys aspects: sample size, follow-up duration, and number of outcomes. Methods We used the Cochrane Schizophrenia Group's register that contains 16,000 citations to 13,000 studies relating only to people with schizophrenia or schizophrenia-like illness. Randomized controlled trials and controlled clinical trials undertaken in Italy and involving pharmacological interventions were included. Results The original search identified 155 records of potentially eligible studies, 74 of which were excluded because do not meet inclusion criteria. A total of 81 studies were included in the analysis. The majority of trials were conducted in north Italy, and published in international journals between 1981 and 1995. The majority of studies (52 out of 81 used standardized diagnostic criteria for schizophrenia disorder. They were defined as randomized and used blind methods to administer

Family planning to promote physical activity: a randomized controlled trial protocol.

Science.gov (United States)

Quinlan, Alison; Rhodes, Ryan E; Blanchard, Chris M; Naylor, Patti-Jean; Warburton, Darren E R

2015-10-05

Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines. A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families. This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families. This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the

Why Current Statistics of Complementary Alternative Medicine Clinical Trials is Invalid.

Science.gov (United States)

Pandolfi, Maurizio; Carreras, Giulia

2018-06-07

It is not sufficiently known that frequentist statistics cannot provide direct information on the probability that the research hypothesis tested is correct. The error resulting from this misunderstanding is compounded when the hypotheses under scrutiny have precarious scientific bases, which, generally, those of complementary alternative medicine (CAM) are. In such cases, it is mandatory to use inferential statistics, considering the prior probability that the hypothesis tested is true, such as the Bayesian statistics. The authors show that, under such circumstances, no real statistical significance can be achieved in CAM clinical trials. In this respect, CAM trials involving human material are also hardly defensible from an ethical viewpoint.

Smart Technology in Lung Disease Clinical Trials.

Science.gov (United States)

Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

2016-01-01

This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research. Published by Elsevier Inc.

Have Recent Vertebroplasty Trials Changed the Indications for Vertebroplasty?

International Nuclear Information System (INIS)

Gangi, Afshin; Clark, William A.

2010-01-01

Two different investigators in the New England Journal of Medicine recently published two randomized controlled trials (RCTs) regarding the efficacy of vertebroplasty for painful osteoporotic vertebral compression fractures. In their results, both investigators concluded that there was no significant difference in pain relief between the vertebroplasty group and control group 1 month after treatment. The trials described a different patient cohort from the one we treat with vertebroplasty. Both enrolled patients had back pain for ≤12 months. This duration of pain was far too long for a vertebroplasty trial, resulting in parallel trials of vertebroplasty on healed fractures. Where a study is needed, it should be comprised of patients with acute osteoporotic compression fractures, particularly those who are hospitalized or bedridden because of the pain of such fractures. Magnetic resonance imaging was not systematically performed before vertebroplasty, and inpatients were excluded. Inpatients with acute fracture pain are the group most likely to respond well to vertebroplasty. Enrolment was a problem in both trials. Randomization in both RCTs took >4 years for completion. We advise that vertebroplasty be offered to patients with recent fractures <8 weeks old who have uncontrolled pain as well as patients progressing to osteonecrosis and the intravertebral vacuum phenomenon (Kummels disease). The availability of recent MRI scanning is also critical to proper patient selection.

Remune trial will stop; new trials planned.

Science.gov (United States)

James, J S

1999-05-21

A clinical trial using remune, the anti-HIV vaccine developed by the late Dr. Jonas Salk, has been ended. The study is a clinical-endpoint trial which looks for statistically significant differences in AIDS sickness or death between patients who add remune to their treatment regimens versus those who use a placebo. Agouron Pharmaceuticals and the Immune Response Corporation who were conducting the trial announced their decision to stop it after an analysis by the Data Safety Monitoring Board. No differences in clinical endpoints were found and it was projected that continuing the trial would likely not find any. The companies are now planning two new Phase III trials using viral load testing rather than clinical endpoints as study criteria.

Correction of technical bias in clinical microarray data improves concordance with known biological information

DEFF Research Database (Denmark)

Eklund, Aron Charles; Szallasi, Zoltan Imre

2008-01-01

The performance of gene expression microarrays has been well characterized using controlled reference samples, but the performance on clinical samples remains less clear. We identified sources of technical bias affecting many genes in concert, thus causing spurious correlations in clinical data...... sets and false associations between genes and clinical variables. We developed a method to correct for technical bias in clinical microarray data, which increased concordance with known biological relationships in multiple data sets....

Glycosylated haemoglobin is markedly elevated in new and known ...

African Journals Online (AJOL)

Mean HbA1c in known Type 1, known Type 2 and newly diagnosed diabetes patients were similarly ... of diabetes such as retinopathy, nephropathy and neuropathy [3]. ..... dilemma of HbA1c detection in presence of a haemoglobinopathy: A ...

Clinical Trials

Medline Plus

Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

A Big Five facet analysis of sub-clinical narcissism: understanding boldness in terms of well-known personality traits.

Science.gov (United States)

Furnham, Adrian; Crump, John

2014-08-01

This study aimed to examine a Big Five 'bright-side' analysis of a sub-clinical personality disorder, i.e. narcissism. A total of 6957 British adults completed the NEO-PI-R, which measures the Big Five Personality factors at the domain and the facet level, as well as the Hogan Development Survey (HDS), which has a measure of Narcissism called Bold as one of its dysfunctional interpersonal tendencies. Correlation and regression results confirmed many of the associations between the Big Five domains and facets (NEO-PI-R) and sub-clinical narcissism. The Bold (Narcissism) scale from the HDS was the criterion variable in all analyses. Bold individuals are disagreeable extraverts with very low scores on facet Modesty but moderately high scores on Assertiveness, Competence and Achievement Striving. The study confirmed work using different population groups and different measures. Copyright © 2014 John Wiley & Sons, Ltd.

Reference Sources: Little Known to Basic

Science.gov (United States)

RQ, 1970

1970-01-01

This article lists seventy-eight reference sources, and is divided into the following four sections: (1) Useful But Little-Known Reference Tools by John Fetros, (2) The Statesman's Year-Book by James Becker, (3) Single Volume Scientific Encyclopedias by Jack Clarke and (4) Ten Basic Sources of Business and Economic Statistics by James Woy. (MF)

The efficacy of antidepressants on overall well-being and self-reported depression symptom severity in youth: a meta-analysis.

Science.gov (United States)

Spielmans, Glen I; Gerwig, Katherine

2014-01-01

Recent meta-analyses of the efficacy of second-generation antidepressants for youth have concluded that such drugs possess a statistically significant advantage over placebo in terms of clinician-rated depressive symptoms. However, no meta-analysis has included measures of quality of life, global mental health, self-esteem, or autonomy. Further, prior meta-analyses have not included self-reports of depressive symptoms. Studies were selected through searching Medline, PsycINFO, and the Cochrane Central Register for Controlled Trials databases as well as GlaxoSmithKline's online trial registry. We included self-reports of depressive symptoms and pooled measures of quality of life, global mental health, self-esteem, and autonomous functioning as a proxy for overall well-being. We found a nonsignificant difference between second-generation antidepressants and placebo in terms of self-reported depressive symptoms (k = 6 trials, g = 0.06, p = 0.36). Further, pooled across measures of quality of life, global mental health, self-esteem, and autonomy, antidepressants yielded no significant advantage over placebo (k = 3 trials, g = 0.11, p = 0.13). Though limited by a small number of trials, our analyses suggest that antidepressants offer little to no benefit in improving overall well-being among depressed children and adolescents. © 2014 S. Karger AG, Basel.

Controlled clinical trial of how mobile health applications affect blue-collar men’s physical health as well as thoughts and actions in relation to their own physical health

DEFF Research Database (Denmark)

Levisen, Vinie Diana Hvidbak; Castaño, Francisco Mansilla; Jensen, Camilla Skovbjerg

2017-01-01

applications affect the level of physical activity amongst blue collar men as well as the frequency of how often they think and do something for their own physical health. Methods: Controlled clinical trial, men, aged 19–62 years, working in industrial companies, who are assigned to an intervention group (n=35.......9 to 68.8 kg (P=0.02); oxygen absorption in the fitness test, from 3.09 to 3.22 L/min (P=0.03); VAS, how often the men do something to improve their own physical health, from 6.00 to 7.00 (P=0.0051). There are improved parameters in the intervention group for resting heart rate (RHR), fitness test, fat......-by-step control increases the physical activity level of blue-collar men as well as how often they think and do something to improve their physical health. Significant improvement is seen in their muscle mass and oxygen uptake as well as in relation to how often they do something to improve their own health....

Low-cost glass ionomer cement as ART sealant in permanent molars: a randomized clinical trial

Directory of Open Access Journals (Sweden)

Daniela HESSE

2015-01-01

Full Text Available Clinical trials are normally performed with well-known brands of glass ionomer cement (GIC, but the cost of these materials is high for public healthcare in less-affluent communities. Given the need to research cheaper materials, it seems pertinent to investigate the retention rate of a low-cost GIC applied as atraumatic restorative treatment (ART sealants in two centers in Brazil. Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil. The children were randomly divided into two groups, according to the tested GIC applied in the first permanent molars. The retention rate was evaluated after 3, 6 and 12 months. Kaplan-Meier survival analysis and the log-rank test were performed. The variables were tested for association with sealant longevity, using logistic regression analyses (α = 5%. The retention rate of sealants after 12 months was 19.1%. The high-cost GIC brand presented a 2-fold-more-likely-to-survive rate than the low-cost brand (p < 0.001. Significant difference was also found between the cities where the treatments were performed, in that Barueri presented a higher sealant survival rate than Recife (p < 0.001. The retention rate of a low-cost GIC sealant brand was markedly lower than that of a well-known GIC sealant brand.

A qualitative analysis of trainer/coach experiences of changing care home practice in the Well-being and Health in Dementia randomised control trial.

Science.gov (United States)

Fossey, Jane; Garrod, Lucy; Guzman, Azucena; Testad, Ingelin

2018-01-01

Objectives This study explored the experiences of a range of health and social care professionals employed in the role of trainer/coaches to support care home staff to implement a psychosocial intervention for residents living with dementia. It aimed to identify the factors which are pertinent to these roles, in the context of a cascade model of training. Method A focus group was convened involving dementia trainer/coaches and supervisors who had worked on Well-being and Health for people with Dementia randomised control trial. Twelve participants explored their preparedness for and experiences of their role as 'Well-being and Health for people with Dementia therapists'. They reflected on their perceptions of the resources and support required. The data were transcribed verbatim and subjected to inductive thematic analysis. Results Three main themes emerged from the data. Within the theme of 'skills in relationship building' were two subthemes of developing trust and getting to know individual staff and each care home. In the second main theme of 'making use of tangible resources' two subthemes relating to using the Well-being and Health for people with Dementia manuals and the supervision of the therapists arose. The third theme, 'being an agent for change' contained three subthemes: effective training methods, creating opportunities for Dementia Champions to reflect and therapists' perceived rewards of their role. Conclusion The findings provide new insights into the trainer/coach role applicable to the practices of services recruiting, training and providing ongoing professional support to practitioners in-reaching into care homes.

Clinical Trials

Medline Plus

Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

PDVSA INTEVEP Technologies in oil well drilling

International Nuclear Information System (INIS)

Bolivar, C.; Rafael, A.; Davila, Manuel A.

1998-01-01

The orimulsion, the generation of catalytic technologies and the development of HDH (process which transform heavy crudes in light crudes), are examples of some of the well known technologies developed by PDVSA INTEVEP. But the drilling oil wells technologies developed by the same entreprise, even though are very important, are less known all around the world. This document describes some products developed through those technologies: THIXOGAS T M which is an antimigratory aditive; INTEFLOW T M which is a fluid for drilling, complementation and rehabilitation of oil drills; INTERCAB T M which is an aditive for fluids in drilling; orimatita which is a denser for drilling fluids; CARBOLIG T M which is an aditive for drilling fluids; and many other products and technologies in development, impacted considerably the venezuelan economy by preserving the environment and saving quite an important amount of money in 1997 (Bs. 3.000 M M)

Semiconductors and semimetals intersubband transitions in quantum wells physics and device applications

CERN Document Server

Weber, Eicke R; Liu, H C

1999-01-01

Since its inception in 1966, the series of numbered volumes known as Semiconductors and Semimetals has distinguished itself through the careful selection of well-known authors, editors, and contributors. The Willardson and Beer series, as it is widely known, has succeeded in producing numerous landmark volumes and chapters. Not only did many of these volumes make an impact at the time of their publication, but they continue to be well-cited years after their original release. Recently, Professor Eicke R. Weber of the University of California at Berkeley joined as a co-editor of the series. Pro

Modern turtle origins: the oldest known cryptodire.

Science.gov (United States)

Gaffney, E S; Hutchison, J H; Jenkins, F A; Meeker, L J

1987-07-17

The discovery of a turtle in the Early Jurassic(185 million years before present) Kayenta Formation of northeastern Arizona provides significant evidence about the origin of modern turtles. This new taxon possesses many of the primitive features expected in the hypothetical common ancestor of pleurodires and cryptodires, the two groups of modern turtles. It is identified as the oldest known cryptodire because of the presence of a distinctive cryptodiran jaw mechanism consisting of a trochlea over the otic chamber that redirects the line of action of the adductor muscle. Aquatic habits appear to have developed very early in turtle evolution. Kayentachelys extends the known record of cryptodires back at least 45 million years and documents a very early stage in the evolution of modern turtles.

Systematic Convergence in Applying Variational Method to Double-Well Potential

Science.gov (United States)

Mei, Wai-Ning

2016-01-01

In this work, we demonstrate the application of the variational method by computing the ground- and first-excited state energies of a double-well potential. We start with the proper choice of the trial wave functions using optimized parameters, and notice that accurate expectation values in excellent agreement with the numerical results can be…

Recent clinical trials in idiopathic pulmonary fibrosis and the BUILD-1 study

Directory of Open Access Journals (Sweden)

K. K. Brown

2008-12-01

Full Text Available Idiopathic pulmonary fibrosis (IPF, the most common of the interstitial pneumonias, is a progressive, life-limiting disease for which there are no truly effective therapies. In patients with biopsy-confirmed IPF, median survival is still <3 yrs. Although potent immunosuppressive therapy has underpinned the treatment of IPF in recent years and remains the standard of care, there is little quality evidence to support the efficacy and safety of traditional therapeutic strategies. This has spurred the search for new treatments for IPF and has led to a series of clinical trials of new therapies, seven of which are reviewed herein. They include the Bosentan Use in Interstitial Lung Disease (BUILD-1 trial, the results of which are discussed in detail, the European Idiopathic Pulmonary Fibrosis International Group Exploring N-acetylcysteine 1 Annual (IFIGENIA trial, the interferon gamma (GIPF-001 trial and the INSPIRE trial, as well as trials of anticoagulant therapy, pirfenidone and etanercept. Treatment trials in IPF are hindered by difficulties in achieving a secure diagnosis of IPF and the lack of validated outcome measures that represent either improvement or progression of disease. These and other limitations are discussed in the present article, as well as how some of these problems might be addressed in future trials. Although few of the seven studies met their primary end-points, marginal trends either on primary end-points or statistically significant trends on exploratory end-points were a recurrent theme in most trials. In the BUILD-1 trial, for example, a trend in favour of bosentan was observed on time-to-disease progression or death.

Monitoring of psychological well-being in outpatients with diabetes

DEFF Research Database (Denmark)

Pouwer, F; Snoek, Frank J; Van Der Ploeg, Henk M

2001-01-01

OBJECTIVE: To investigate whether monitoring and discussing psychological well-being in outpatients with diabetes improves mood, glycemic control, and the patient's evaluation of the quality of diabetes care. RESEARCH DESIGN AND METHODS: This study was a randomized controlled trial of 461...... outpatients with diabetes who were randomly assigned to standard care or to the monitoring condition. In the latter group, the diabetes nurse specialist assessed and discussed psychological well-being with the patient (with an interval of 6 months) in addition to standard care. The computerized Well...... nurse. The two groups did not differ for HbA(1c) or in their overall evaluation of the quality of diabetes care. In the monitoring condition, significantly more subjects were referred to the psychologist. CONCLUSIONS: Monitoring and discussing psychological well-being as part of routine diabetes...

Clinical Trials

Medline Plus

Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

GUARANTEES OF THE RIGHT TO A FAIR CIVIL TRIAL

Directory of Open Access Journals (Sweden)

Diana-Loredana Jalbă

2015-11-01

Full Text Available In order to ensure the effective protection of human rights and provide for more than theoretical and illusory substantive rights, the need to define the right to a fair trial is emerging, along with the necessity that litigants become aware of the guarantees established by article 6 of the European Convention on Human Rights. Thus, the article aims to approach the ample issue regarding the litigants’ right to a fair civil trial in light of current legal regulations, and in particular, in light of the jurisprudence of the European Court of Human Rights. Given the fact that the right to a fair civil trial involves establishing, throughout the trial, a set of rules of procedure aimed at creating a balance between the parties in the process - the so-called guarantees of a fair trial - in her scientific pursuits, the author analyzes both explicit and implicit guarantees of fair trial, highlighting relevant European standards as well as their degree of implementation in the national (procedural law.

Physical activity and trial-by-trial adjustments of response conflict.

Science.gov (United States)

Kamijo, Keita; Takeda, Yuji

2013-08-01

The relationship of physical activity to trial-by-trial adjustments of response conflict was assessed using behavioral task performance, the N2 event-related brain potential component, and phase-locking values (PLVs) in a lower gamma band during a perceptual conflict task. Nineteen physically active and 19 inactive young adults (mean age = 21.3 years) performed a Navon task, using a global letter made up of local letters of either the same kind (congruent trials) or a different kind (incongruent trials). Findings revealed that active individuals exhibited smaller N2 amplitudes and greater PLVs on incongruent trials that were preceded by incongruent trials compared with those preceded by congruent trials. Such phenomena were not observed for inactive individuals. These results suggest that greater physical activity is associated with larger trial-by-trial adjustments of response conflict, which we attribute to upregulation of top-down cognitive control and reductions in response conflict.

The IGNITE (investigation to guide new insight into translational effectiveness trial: Protocol for a translational study of an evidenced-based wellness program in fire departments

Directory of Open Access Journals (Sweden)

MacKinnon David P

2010-10-01

Full Text Available Abstract Background Worksites are important locations for interventions to promote health. However, occupational programs with documented efficacy often are not used, and those being implemented have not been studied. The research in this report was funded through the American Reinvestment and Recovery Act Challenge Topic 'Pathways for Translational Research,' to define and prioritize determinants that enable and hinder translation of evidenced-based health interventions in well-defined settings. Methods The IGNITE (investigation to guide new insights for translational effectiveness trial is a prospective cohort study of a worksite wellness and injury reduction program from adoption to final outcomes among 12 fire departments. It will employ a mixed methods strategy to define a translational model. We will assess decision to adopt, installation, use, and outcomes (reach, individual outcomes, and economic effects using onsite measurements, surveys, focus groups, and key informant interviews. Quantitative data will be used to define the model and conduct mediation analysis of each translational phase. Qualitative data will expand on, challenge, and confirm survey findings and allow a more thorough understanding and convergent validity by overcoming biases in qualitative and quantitative methods used alone. Discussion Findings will inform worksite wellness in fire departments. The resultant prioritized influences and model of effective translation can be validated and manipulated in these and other settings to more efficiently move science to service.

Clinical trials in dentistry in India: Analysis from trial registry.

Science.gov (United States)

Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

Imaging and Data Acquisition in Clinical Trials for Radiation Therapy

Energy Technology Data Exchange (ETDEWEB)

FitzGerald, Thomas J., E-mail: Thomas.Fitzgerald@umassmed.edu [Imaging and Radiation Oncology Core Rhode Island, University of Massachusetts Memorial Medical Center, University of Massachusetts Medical School, Worcester, Massachusetts (United States); Bishop-Jodoin, Maryann [Imaging and Radiation Oncology Core Rhode Island, University of Massachusetts Medical School, Worcester, Massachusetts (United States); Followill, David S. [Imaging and Radiation Oncology Core Houston, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Galvin, James [Imaging and Radiation Oncology Core Philadelphia, Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Knopp, Michael V. [Imaging and Radiation Oncology Core Ohio, Wexner Medical Center, Ohio State University, Columbus, Ohio (United States); Michalski, Jeff M. [Imaging and Radiation Oncology Core St. Louis, Washington University School of Medicine, St. Louis, Missouri (United States); Rosen, Mark A. [Imaging and Radiation Oncology Core Philadelphia, University of Pennsylvania Health System, Philadelphia, Pennsylvania (United States); Bradley, Jeffrey D. [Washington University School of Medicine–Radiation Oncology, St. Louis, Missouri (United States); Shankar, Lalitha K. [National Cancer Institute, Clinical Radiation Oncology Branch, Rockville, Maryland (United States); Laurie, Fran [Imaging and Radiation Oncology Core Rhode Island, University of Massachusetts Medical School, Worcester, Massachusetts (United States); Cicchetti, M. Giulia; Moni, Janaki [Imaging and Radiation Oncology Core Rhode Island, University of Massachusetts Memorial Medical Center, University of Massachusetts Medical School, Worcester, Massachusetts (United States); Coleman, C. Norman; Deye, James A.; Capala, Jacek; Vikram, Bhadrasain [National Cancer Institute, Clinical Radiation Oncology Branch, Rockville, Maryland (United States)

2016-02-01

Cancer treatment evolves through oncology clinical trials. Cancer trials are multimodal and complex. Assuring high-quality data are available to answer not only study objectives but also questions not anticipated at study initiation is the role of quality assurance. The National Cancer Institute reorganized its cancer clinical trials program in 2014. The National Clinical Trials Network (NCTN) was formed and within it was established a Diagnostic Imaging and Radiation Therapy Quality Assurance Organization. This organization is Imaging and Radiation Oncology Core, the Imaging and Radiation Oncology Core Group, consisting of 6 quality assurance centers that provide imaging and radiation therapy quality assurance for the NCTN. Sophisticated imaging is used for cancer diagnosis, treatment, and management as well as for image-driven technologies to plan and execute radiation treatment. Integration of imaging and radiation oncology data acquisition, review, management, and archive strategies are essential for trial compliance and future research. Lessons learned from previous trials are and provide evidence to support diagnostic imaging and radiation therapy data acquisition in NCTN trials.

Imaging and Data Acquisition in Clinical Trials for Radiation Therapy

International Nuclear Information System (INIS)

FitzGerald, Thomas J.; Bishop-Jodoin, Maryann; Followill, David S.; Galvin, James; Knopp, Michael V.; Michalski, Jeff M.; Rosen, Mark A.; Bradley, Jeffrey D.; Shankar, Lalitha K.; Laurie, Fran; Cicchetti, M. Giulia; Moni, Janaki; Coleman, C. Norman; Deye, James A.; Capala, Jacek; Vikram, Bhadrasain

2016-01-01

Cancer treatment evolves through oncology clinical trials. Cancer trials are multimodal and complex. Assuring high-quality data are available to answer not only study objectives but also questions not anticipated at study initiation is the role of quality assurance. The National Cancer Institute reorganized its cancer clinical trials program in 2014. The National Clinical Trials Network (NCTN) was formed and within it was established a Diagnostic Imaging and Radiation Therapy Quality Assurance Organization. This organization is Imaging and Radiation Oncology Core, the Imaging and Radiation Oncology Core Group, consisting of 6 quality assurance centers that provide imaging and radiation therapy quality assurance for the NCTN. Sophisticated imaging is used for cancer diagnosis, treatment, and management as well as for image-driven technologies to plan and execute radiation treatment. Integration of imaging and radiation oncology data acquisition, review, management, and archive strategies are essential for trial compliance and future research. Lessons learned from previous trials are and provide evidence to support diagnostic imaging and radiation therapy data acquisition in NCTN trials.

A systematic review of the usage of flow diagram in cluster randomized trials

Directory of Open Access Journals (Sweden)

Kostić M.

2014-01-01

Full Text Available Flow diagram represent an integral part of consolidated standards of reporting trials (CONSORT. Its use in reporting cluster randomization trials is highly recommended. The aim of this article is to present frequency of the use of flow diagram in cluster randomized trials in accordance with standards of reporting. The team has researched Medline database and singled-out 474 studies with cluster randomization for analysis. The studies were reviewed to identify the use of graphic representation, compliance with standards of reporting and the date when study was published. Depending from its duration, studies were divided on completed, and those still ongoing. Usage of CONSORT is recorded in 145 (31% literature units. Frequency of flow diagram was statistically much higher in studies which were in compliance with standards (86,2%, in comparison to those which did not use CONSORT guidelines (71,4%, as well as in completed studies (81,2% in comparison to pilot project studies (54,3%. Number of cluster randomized trials gathered through MEDLINE's search of key words 'cluster randomized trial [ti]' and 'cluster randomised trial [ti]', as well as the use of CONSORT in the reports of cluster randomized trials, are showing linear growth over time (p<0,001. Frequency of flow diagram is higher in the reports of cluster randomized trials that were done in accordance with the standards of reporting.

Conductance in double quantum well systems

International Nuclear Information System (INIS)

Hasbun, J E

2003-01-01

The object of this paper is to review the electronic conductance in double quantum well systems. These are quantum well structures in which electrons are confined in the z direction by large band gap material barrier layers, yet form a free two-dimensional Fermi gas within the sandwiched low band gap material layers in the x-y plane. Aspects related to the conductance in addition to the research progress made since the inception of such systems are included. While the review focuses on the tunnelling conductance properties of double quantum well devices, the longitudinal conductance is also discussed. Double quantum well systems are a more recent generation of structures whose precursors are the well known double-barrier resonant tunnelling systems. Thus, they have electronic signatures such as negative differential resistance, in addition to resonant tunnelling, whose behaviours depend on the wavefunction coupling between the quantum wells. As such, the barrier which separates the quantum wells can be tailored in order to provide better control of the device's electronic properties over their single well ancestors. (topical review)

Statins in heart failure: do we need another trial?

OpenAIRE

Bonsu, Kwadwo Osei; Kadirvelu, Amudha; Reidpath, Daniel Diamond

2013-01-01

Kwadwo Osei Bonsu, Amudha Kadirvelu, Daniel Diamond ReidpathSchool of Medicine and Health Sciences, Monash University Sunway Campus, Bandar Sunway, MalaysiaAbstract: Statins lower serum cholesterol and are employed for primary and secondary prevention of cardiovascular events. Clinical evidence from observational studies, retrospective data, and post hoc analyses of data from large statin trials in various cardiovascular conditions, as well as small scale randomized trials, suggest survival a...

Trial endpoints for drug approval in oncology: Chemoprevention.

Science.gov (United States)

Beitz, J

2001-04-01

As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.

The Development of an Internet-Based Treatment for Problem Gamblers and Concerned Significant Others: A Pilot Randomized Controlled Trial.

Science.gov (United States)

Nilsson, Anders; Magnusson, Kristoffer; Carlbring, Per; Andersson, Gerhard; Gumpert, Clara Hellner

2018-06-01

Problem gambling creates significant harm for the gambler and for concerned significant others (CSOs). While several studies have investigated the effects of individual cognitive behavioral therapy (CBT) for problem gambling, less is known about the effects of involving CSOs in treatment. Behavioral couples therapy (BCT) has shown promising results when working with substance use disorders by involving both the user and a CSO. This pilot study investigated BCT for problem gambling, as well as the feasibility of performing a larger scale randomized controlled trial. 36 participants, 18 gamblers and 18 CSOs, were randomized to either BCT or individual CBT for the gambler. Both interventions were Internet-delivered self-help interventions with therapist support. Both groups of gamblers improved on all outcome measures, but there were no differences between the groups. The CSOs in the BCT group lowered their scores on anxiety and depression more than the CSOs of those randomized to the individual CBT group did. The implications of the results and the feasibility of the trial are discussed.

Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trial.

Science.gov (United States)

Zenico, T; Cicero, A F G; Valmorri, L; Mercuriali, M; Bercovich, E

2009-04-01

Lepidium meyenii (Maca) is a cultivated root belonging to the brassica family used in the Andean region for its supposed aphrodisiac properties. We carried out a double-blind clinical trial on 50 Caucasian men affected by mild erectile dysfunction (ED), randomised to treatment with Maca dry extract, 2400 mg, or placebo. The treatment effect on ED and subjective well-being was tested administrating before and after 12 weeks the International Index of Erectile Function (IIEF-5) and the Satisfaction Profile (SAT-P). After 12 weeks of treatment, both Maca- and placebo-treated patients experienced a significant increase in IIEF-5 score (P Maca experienced a more significant increase than those taking placebo (1.6 +/- 1.1 versus 0.5 +/- 0.6, P Maca- and placebo-treated subjects experienced a significant improvement in psychological performance-related SAT-P score, but the Maca group higher than that of placebo group (+9 +/- 6 versus +6 +/- 5, P Maca-treated patients experienced a significant improvement in physical and social performance-related SAT-P score compared with the baseline (+7 +/- 6 and +7 +/- 6, both P Maca supplementation on subjective perception of general and sexual well-being in adult patients with mild ED.

Effects of music on work-rate distribution during a cycling time trial.

Science.gov (United States)

Atkinson, G; Wilson, D; Eubank, M

2004-11-01

Previous research work on the ergogenic effects of music has mainly involved constant power tests to exhaustion as dependent variables. Time trials are more externally valid than constant power tests, may be more reliable and allow the distribution of self-selected work-rate to be explored. We examined whether music improved starting, finishing and/or overall power during a 10-km cycling time trial, and whether heart rate and subjective responses to this time trial were altered by music. Sixteen participants performed two 10-km time trials on a Cybex cycle ergometer with, and without, the presence of a form of dance music known as "trance" (tempo = 142 beats x min (-1), volume at ear = 87 dB). Participants also completed the Brunel music rating inventory (BMRI) after each time trial in the music condition. The mean +/- SD time to complete the time trial was 1030 +/- 79 s in the music condition compared to 1052 +/- 77 s without music (95 % CI of difference = 10 to 34 s, p = 0.001). Nevertheless, ratings of perceived exertion were consistently (0.8 units) higher throughout the time trial with music (p music-induced increases in cycling speed and heart rate were observed in the first 3 km of the time trial. After completion of the BMRI, participants rated the "tempo" and "rhythm" of the music as more motivating than the "harmony" and "melody" aspects. These results suggest that music improves cycling speed mostly in the first few minutes of a 10-km time trial. In contrast to the findings of previous research, which suggested that music lowers perceived exertion at a constant work-rate, the participants in our time trials selected higher work-rates with music, whilst at the same time perceived these work-rates as being harder than without music.

Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).

Science.gov (United States)

Durant, Raegan W; Wenzel, Jennifer A; Scarinci, Isabel C; Paterniti, Debora A; Fouad, Mona N; Hurd, Thelma C; Martin, Michelle Y

2014-04-01

The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority populations. Yet very little is known about the perceptions of individuals actively involved in minority recruitment to clinical trials within cancer centers. Therefore, the authors assessed the perspectives of cancer center clinical and research personnel on barriers and facilitators to minority recruitment. In total, 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, research staff, and referring clinicians. All interviews were recorded and transcribed. Qualitative analyses of response data was focused on identifying prominent themes related to barriers and facilitators to minority recruitment. The perspectives of the 4 stakeholder groups were largely overlapping with some variations based on their unique roles in minority recruitment. Four prominent themes were identified: 1) racial and ethnic minorities are influenced by varying degrees of skepticism related to trial participation, 2) potential minority participants often face multilevel barriers that preclude them from being offered an opportunity to participate in a clinical trial, 3) facilitators at both the institutional and participant level potentially encourage minority recruitment, and 4) variation between internal and external trial referral procedures may limit clinical trial opportunities for racial and ethnic minorities. Multilevel approaches are needed to address barriers and optimize facilitators within cancer centers to enhance minority recruitment for cancer clinical trials. © 2014 American Cancer Society.

Facilitation: A Novel Way to Improve Students' Well-being

DEFF Research Database (Denmark)

Adriansen, Hanne Kirstine Olesen; Madsen, Lene Møller

2013-01-01

In this article we analyze a project that used facilitation techniques, which are known from training in industry, to improve the study environment at a public research university in Denmark. In 2009, the project was initiated in one graduate program; and it has subsequently been modified...... and institutionalized. The project did not change the teaching format, but introduced facilitated study-groups using peer learning. Itwas successful in increasing students’ well-being. While peer learning and study groups are well-known in higher education, facilitation is a different and novel tool. We argue...... that facilitation makes study groups more inclusive, and they provide the potential for deep learning by structuring the learning situation...

Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

Directory of Open Access Journals (Sweden)

Rahu Mati

2008-08-01

donate drugs but they take a financial risk, especially with licensed drugs. Public funding is crucial to avoid commercial biases. Legislation to share the costs of large post-marketing trials as well as regulation of manufacturer's participation is needed. [ISRCTN35338757

Recruitment to publicly funded trials--are surgical trials really different?

Science.gov (United States)

Cook, Jonathan A; Ramsay, Craig R; Norrie, John

2008-09-01

Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.

77 FR 31909 - The Designation of Abdallah Azzam Brigades, Also Known as Abdullah Azzam Brigades, Also Known as...

Science.gov (United States)

2012-05-30

... DEPARTMENT OF STATE [Public Notice 7899] The Designation of Abdallah Azzam Brigades, Also Known as... Abdullah Azzam Brigades, committed, or poses a significant risk of committing, acts of terrorism that... States. Consistent with the determination in section 10 of Executive Order 13224 that ``prior notice to...

Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

Science.gov (United States)

Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

2012-07-01

Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

Motivators of enrolment in HIV vaccine trials: a review of HIV vaccine preparedness studies.

Science.gov (United States)

Dhalla, Shayesta; Poole, Gary

2011-11-01

HIV vaccine preparedness studies (VPS) are important precursors to HIV vaccine trials. As well, they contribute to an understanding of motivators and barriers for participation in hypothetical HIV vaccine trials. Motivators can take the form of altruism and a desire for social benefits. Perceived personal benefits, including psychological, personal, and financial well-being, may also motivate participation. The authors performed a systematic review of HIV VPS using the Cochrane Database for Systematic Reviews, Medline, PubMed, Embase, and Google Scholar. The authors independently searched the literature for individual HIV VPS that examined motivators of participation in a hypothetical HIV vaccine trial, using the same search strategy. As the denominators employed in the literature varied across studies, the denominators were standardized to the number of respondents per survey item, regardless of their willingness to participate (WTP) in an HIV vaccine trial. The authors retrieved eight studies on social benefits (i.e., altruism) and 11 studies on personal benefits conducted in the Organization for Economic Co-operation and Development (OECD) countries, as well as 19 studies on social benefits and 20 studies on personal benefits in the non-OECD countries. Various different forms of altruism were found to be the major motivators for participation in an HIV vaccine trial in both the OECD and the non-OECD countries. In a large number of studies, protection from HIV was cited as a personal motivator for participation in a hypothetical HIV vaccine trial in the OECD and the non-OECD countries. Knowledge of motivators can inform and target recruitment for HIV vaccine trials, although it must be remembered that hypothetical motivators may not always translate into motivators in an actual vaccine trial.

Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial.

Science.gov (United States)

Tanaka, Atsushi; Shimabukuro, Michio; Okada, Yosuke; Taguchi, Isao; Yamaoka-Tojo, Minako; Tomiyama, Hirofumi; Teragawa, Hiroki; Sugiyama, Seigo; Yoshida, Hisako; Sato, Yasunori; Kawaguchi, Atsushi; Ikehara, Yumi; Machii, Noritaka; Maruhashi, Tatsuya; Shima, Kosuke R; Takamura, Toshinari; Matsuzawa, Yasushi; Kimura, Kazuo; Sakuma, Masashi; Oyama, Jun-Ichi; Inoue, Teruo; Higashi, Yukihito; Ueda, Shinichiro; Node, Koichi

2017-04-12

Type 2 diabetes mellitus (T2DM) is characterized by systemic metabolic abnormalities and the development of micro- and macrovascular complications, resulting in a shortened life expectancy. A recent cardiovascular (CV) safety trial, the EMPA-REG OUTCOME trial, showed that empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, markedly reduced CV death and all-cause mortality and hospitalization for heart failure in patients with T2DM and established CV disease (CVD). SGLT2 inhibitors are known to not only decrease plasma glucose levels, but also favorably modulate a wide range of metabolic and hemodynamic disorders related to CV pathways. Although some experimental studies revealed a beneficial effect of SGLT2 inhibitors on atherosclerosis, there is a paucity of clinical data showing that they can slow the progression of atherosclerosis in patients with T2DM. Therefore, the EMBLEM trial was designed to investigate whether empagliflozin treatment can improve endothelial function, which plays a pivotal role in the pathogenesis of atherosclerosis, in patients with T2DM and established CVD. The EMBLEM trial is an ongoing, prospective, multicenter, placebo-controlled double-blind randomized, investigator-initiated clinical trial in Japan. A total of 110 participants with T2DM (HbA1c range 6.0-10.0%) and with established CVD will be randomized (1:1) to receive either empagliflozin 10 mg once daily or a placebo. The primary endpoint of the trial is change in the reactive hyperemia (RH)-peripheral arterial tonometry-derived RH index at 24 weeks from baseline. For comparison of treatment effects between the treatment groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for the following allocation factors: HbA1c (EMBLEM is the first trial to assess the effect of empagliflozin on endothelial function in patients with T2DM and established CVD. Additionally, mechanisms associating

Extremity dosimetry trial: Devonport royal dockyard

International Nuclear Information System (INIS)

Kenyon, R.; Collison, R.

2008-01-01

This trial was undertaken to assess extremity dosemeters, which were made available to Devonport Royal Dockyard and determine the most suitable to the site. The trial included operational and laboratory-based exposures. Operational exposures were within a submarine reactor compartment and a waste storage area. Laboratory exposures were undertaken using 241 Am, 137 Cs and 60 Co sources to compare and contrast the dosemeters energy response. In addition, the low dose response and the response if placed in the incorrect orientation were also assessed. Ten passive and two active dosemeters were tested, with three highlighted as the most technically suitable, DSTL Harshaw DXT-RAD, HPA Harshaw EXT-RAD and the AMEC Panasonic UD-807A. The most technically suitable dosemeter was the DSTL Harshaw DXT-RAD, due to good responses within all aspects of the trial and the user's preference for the ring type design. The John Caunt ED2 electronic dosemeter 2 (ED2) also performed well, but suffered radio frequency interference. (authors)

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Overgaard Hans J

2012-10-01

Full Text Available Abstract Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA; dengue interventions (DEN; combined diarrhea and dengue interventions (DIADEN; and control (C. Schools were allocated publicly in each municipality (strata at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de

The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Clare Linda

2012-07-01

Full Text Available Abstract Background Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. Methods/design This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75 will be randomized to one of three conditions: control (an interview involving a general discussion about the center; goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement; or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring. All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life, cognitive (memory and executive function, and physical fitness (functional and metabolic domains. Cost-effectiveness will also be examined. Discussion This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. Trial Registration Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com

Cell agglomeration in the wells of a 24-well plate using acoustic streaming.

Science.gov (United States)

Kurashina, Yuta; Takemura, Kenjiro; Friend, James

2017-02-28

Cell agglomeration is essential both to the success of drug testing and to the development of tissue engineering. Here, a MHz-order acoustic wave is used to generate acoustic streaming in the wells of a 24-well plate to drive particle and cell agglomeration. Acoustic streaming is known to manipulate particles in microfluidic devices, and even provide concentration in sessile droplets, but concentration of particles or cells in individual wells has never been shown, principally due to the drag present along the periphery of the fluid in such a well. The agglomeration time for a range of particle sizes suggests that shear-induced migration plays an important role in the agglomeration process. Particles with a diameter of 45 μm agglomerated into a suspended pellet under exposure to 2.134 MHz acoustic waves at 1.5 W in 30 s. Additionally, BT-474 cells also agglomerated as adherent masses at the center bottom of the wells of tissue-culture treated 24-well plates. By switching to low cell binding 24-well plates, the BT-474 cells formed suspended agglomerations that appeared to be spheroids, fully fifteen times larger than any cell agglomerates without the acoustic streaming. In either case, the viability and proliferation of the cells were maintained despite acoustic irradiation and streaming. Intermittent excitation was effective in avoiding temperature excursions, consuming only 75 mW per well on average, presenting a convenient means to form fully three-dimensional cellular masses potentially useful for tissue, cancer, and drug research.

The majority of patients with metastatic melanoma are not represented in pivotal phase III immunotherapy trials

DEFF Research Database (Denmark)

Donia, Marco; Kimper-Karl, Marie Louise; Høyer, Katrine Lundby

2017-01-01

BACKGROUND: Recent randomised phase III trials have led to the approval of several immune checkpoint inhibitors for unresectable or metastatic melanoma (MM). These trials all employed strict patient selection criteria, and it is currently unknown how large proportion of 'real-world' patients diag...... a huge knowledge gap regarding the usefulness of new immunotherapies in the 'real-world' patient population, and urge additional testing of known regimens in selected poor prognosis cohorts.......BACKGROUND: Recent randomised phase III trials have led to the approval of several immune checkpoint inhibitors for unresectable or metastatic melanoma (MM). These trials all employed strict patient selection criteria, and it is currently unknown how large proportion of 'real-world' patients...... in 2014, were included in the analysis. Seven pre-defined eligibility criteria, all used to select patients for enrolment in five recent randomised phase III immunotherapy trials, were analysed. RESULTS: Fifty-five percent of the total population with MM did not meet one or more eligibility criteria ('not...

PACES: A Model of Student Well-Being

Science.gov (United States)

Nelson, Mark D.; Tarabochia, Dawn W.; Koltz, Rebecca L.

2015-01-01

School counselors design, deliver, and evaluate comprehensive, developmental school counseling programs that are focused on enhancing student development and success. A model of student well-being, known as PACES, is defined and described that consists of five distinct and interactive domains: physical, affective, cognitive, economic, and social.…

Clinical Trials

Medline Plus

Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

Clinical Trials

Medline Plus

Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

Clinical Trials

Medline Plus

Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

Clinical Trials

Medline Plus

Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

Clinical Trials

Medline Plus

Full Text Available ... clinical trials are vital to the process of improving medical care. Many people volunteer because they want ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

Clinical Trials

Medline Plus

Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

Clinical Trials

Medline Plus

Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

Clinical Trials

Medline Plus

Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

Clinical Trials

Medline Plus

Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

Clinical Trials

Medline Plus

Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

Clinical Trials

Medline Plus

Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

Clinical Trials

Medline Plus

Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

Chromosomal radiosensitivity in breast cancer patients with a known or putative genetic predisposition.

LENUS (Irish Health Repository)

Baeyens, A

2002-12-02

The chromosomal radiosensitivity of breast cancer patients with a known or putative genetic predisposition was investigated and compared to a group of healthy women. The chromosomal radiosensitivity was assessed with the G2 and the G0-micronucleus assay. For the G2 assay lymphocytes were irradiated in vitro with a dose of 0.4 Gy (60)Co gamma-rays after 71 h incubation, and chromatid breaks were scored in 50 metaphases. For the micronucleus assay lymphocytes were exposed in vitro to 3.5 Gy (60)Co gamma-rays at a high dose rate or low dose rate. 70 h post-irradiation cultures were arrested and micronuclei were scored in 1000 binucleate cells. The results demonstrated that the group of breast cancer patients with a known or putative genetic predisposition was on the average more radiosensitive than a population of healthy women, and this with the G2 as well as with the high dose rate and low dose rate micronucleus assay. With the G2 assay 43% of the patients were found to be radiosensitive. A higher proportion of the patients were radiosensitive with the micronucleus assay (45% with high dose rate and 61% with low dose rate). No correlation was found between the G2 and the G0-micronucleus chromosomal radiosensitivity. Out of the different subgroups considered, the group of the young breast cancer patients without family history showed the highest percentage of radiosensitive cases in the G2 (50%) as well as in the micronucleus assay (75-78%).

A critical review of clinical trials in systemic lupus erythematosus

Science.gov (United States)

Mahieu, Mary A.; Strand, Vibeke; Simon, Lee S.; Lipsky, Peter E.; Ramsey-Goldman, Rosalind

2016-01-01

One challenge in caring for patients with systemic lupus erythematosus (SLE) is a paucity of approved therapeutics for treatment of the diverse disease manifestations. In the last 60 years, only one drug, belimumab, has been approved for SLE treatment. Critical evaluation of investigator initiated and pharma-sponsored randomized controlled trials (RCTs) highlights barriers to successful drug development in SLE, including disease heterogeneity, inadequate trial size or duration, insufficient dose finding before initiation of large trials, handling of background medications, and choice of primary endpoint. Herein we examine lessons learned from landmark SLE RCTs and subsequent advances in trial design, as well as discuss efforts to address limitations in current SLE outcome measures that will improve detection of true therapeutic responses in future RCTs. PMID:27497257

Construction of ethics in clinical research: clinical trials registration

Directory of Open Access Journals (Sweden)

C. A. Caramori

2007-01-01

Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

Development and evaluation of "Aging Well and Healthily": A health-education and exercise program for community-living older adults

NARCIS (Netherlands)

Hopman-Rock, M.; Westhoff, M.H.

2002-01-01

The Aging Well and Healthily (AWH) program consists of health education by peers and low-intensity exercise. It was evaluated via a small randomized controlled trial and a community intervention trial involving older adults in the Netherlands. Reasons stated for participation were to exercise (35%),

Ethical considerations in industry-sponsored multiregional clinical trials.

Science.gov (United States)

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

2010-01-01

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

Impact of coaching on university student’s well-being, stress and anxiety

DEFF Research Database (Denmark)

Spaten, Ole Michael

level and increase his or her well-being? An APA database search (Psych Net) has found no experimental study with a similar researchquestion. However, Green et al., (2006) did the first randomized controlled trial examining the effectiveness of a cognitive-behavioural, solution-focused, life coaching...

Clinical Trials

Medline Plus

Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

The effects of extrinsic motivation on signature authorship opinions in forensic signature blind trials.

Science.gov (United States)

Dewhurst, Tahnee N; Found, Bryan; Ballantyne, Kaye N; Rogers, Doug

2014-03-01

Expertise studies in forensic handwriting examination involve comparisons of Forensic Handwriting Examiners' (FHEs) opinions with lay-persons on blind tests. All published studies of this type have reported real and demonstrable skill differences between the specialist and lay groups. However, critics have proposed that any difference shown may be indicative of a lack of motivation on the part of lay participants, rather than a real difference in skill. It has been suggested that qualified FHEs would be inherently more motivated to succeed in blinded validation trials, as their professional reputations could be at risk, should they perform poorly on the task provided. Furthermore, critics suggest that lay-persons would be unlikely to be highly motivated to succeed, as they would have no fear of negative consequences should they perform badly. In an effort to investigate this concern, a blind signature trial was designed and administered to forty lay-persons. Participants were required to compare known (exemplar) signatures of an individual to questioned signatures and asked to express an opinion regarding whether the writer of the known signatures wrote each of the questioned signatures. The questioned signatures comprised a mixture of genuine, disguised and simulated signatures. The forty participants were divided into two separate groupings. Group 'A' were requested to complete the trial as directed and were advised that for each correct answer they would be financially rewarded, for each incorrect answer they would be financially penalized, and for each inconclusive opinion they would receive neither penalty nor reward. Group 'B' was requested to complete the trial as directed, with no mention of financial recompense or penalty. The results of this study do not support the proposition that motivation rather than skill difference is the source of the statistical difference in opinions between individuals' results in blinded signature proficiency trials. Crown

Engineering Online and In-Person Social Networks for Physical Activity: A Randomized Trial.

Science.gov (United States)

Rovniak, Liza S; Kong, Lan; Hovell, Melbourne F; Ding, Ding; Sallis, James F; Ray, Chester A; Kraschnewski, Jennifer L; Matthews, Stephen A; Kiser, Elizabeth; Chinchilli, Vernon M; George, Daniel R; Sciamanna, Christopher N

2016-12-01

Social networks can influence physical activity, but little is known about how best to engineer online and in-person social networks to increase activity. The purpose of this study was to conduct a randomized trial based on the Social Networks for Activity Promotion model to assess the incremental contributions of different procedures for building social networks on objectively measured outcomes. Physically inactive adults (n = 308, age, 50.3 (SD = 8.3) years, 38.3 % male, 83.4 % overweight/obese) were randomized to one of three groups. The Promotion group evaluated the effects of weekly emailed tips emphasizing social network interactions for walking (e.g., encouragement, informational support); the Activity group evaluated the incremental effect of adding an evidence-based online fitness walking intervention to the weekly tips; and the Social Networks group evaluated the additional incremental effect of providing access to an online networking site for walking as well as prompting walking/activity across diverse settings. The primary outcome was mean change in accelerometer-measured moderate-to-vigorous physical activity (MVPA), assessed at 3 and 9 months from baseline. Participants increased their MVPA by 21.0 min/week, 95 % CI [5.9, 36.1], p = .005, at 3 months, and this change was sustained at 9 months, with no between-group differences. Although the structure of procedures for targeting social networks varied across intervention groups, the functional effect of these procedures on physical activity was similar. Future research should evaluate if more powerful reinforcers improve the effects of social network interventions. The trial was registered with the ClinicalTrials.gov (NCT01142804).

Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian-frequentist approach.

Science.gov (United States)

Mielke, Johanna; Schmidli, Heinz; Jones, Byron

2018-05-01

For the approval of biosimilars, it is, in most cases, necessary to conduct large Phase III clinical trials in patients to convince the regulatory authorities that the product is comparable in terms of efficacy and safety to the originator product. As the originator product has already been studied in several trials beforehand, it seems natural to include this historical information into the showing of equivalent efficacy. Since all studies for the regulatory approval of biosimilars are confirmatory studies, it is required that the statistical approach has reasonable frequentist properties, most importantly, that the Type I error rate is controlled-at least in all scenarios that are realistic in practice. However, it is well known that the incorporation of historical information can lead to an inflation of the Type I error rate in the case of a conflict between the distribution of the historical data and the distribution of the trial data. We illustrate this issue and confirm, using the Bayesian robustified meta-analytic-predictive (MAP) approach as an example, that simultaneously controlling the Type I error rate over the complete parameter space and gaining power in comparison to a standard frequentist approach that only considers the data in the new study, is not possible. We propose a hybrid Bayesian-frequentist approach for binary endpoints that controls the Type I error rate in the neighborhood of the center of the prior distribution, while improving the power. We study the properties of this approach in an extensive simulation study and provide a real-world example. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Chelation therapy after the Trial to Assess Chelation Therapy: results of a unique trial

Science.gov (United States)

Avila, Maria D.; Escolar, Esteban; Lamas, Gervasio A.

2014-01-01

Purpose of review EDTA chelation therapy has been in off-label use for the treatment of atherosclerosis. We review the results of the first large-scale randomized trial of this treatment. Recent findings The trial to assess chelation therapy was a $30 million National Institutes of Health-funded study of the safety and efficacy of EDTA-based chelation infusions in 1708 post-myocardial infarction (MI) patients. The trial to assess chelation therapy demonstrated a significant (P = 0.035) 18% reduction in a combined primary endpoint of death, MI, stroke, coronary revascularization, or hospitalization for angina. In diabetic patients the benefit was more extreme, with a 41% relative reduction in risk (P = 0.0002) and a 43% reduction in total mortality (P = 0.011). Safety data were favorable. A reduction of oxidative stress by chelation of toxic metals has been proposed as a possible mechanism of action. Summary Recent research suggests that EDTA chelation may be a well-tolerated and effective treatment for post-MI patients. Future replication and mechanistic studies are important prior to implementation in all post-MI patients. PMID:25023079

Clinical Trials

Medline Plus

Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

Directory of Open Access Journals (Sweden)

Joseph S Ross

2009-09-01

Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

Dose escalation methods in phase I cancer clinical trials.

Science.gov (United States)

Le Tourneau, Christophe; Lee, J Jack; Siu, Lillian L

2009-05-20

Phase I clinical trials are an essential step in the development of anticancer drugs. The main goal of these studies is to establish the recommended dose and/or schedule of new drugs or drug combinations for phase II trials. The guiding principle for dose escalation in phase I trials is to avoid exposing too many patients to subtherapeutic doses while preserving safety and maintaining rapid accrual. Here we review dose escalation methods for phase I trials, including the rule-based and model-based dose escalation methods that have been developed to evaluate new anticancer agents. Toxicity has traditionally been the primary endpoint for phase I trials involving cytotoxic agents. However, with the emergence of molecularly targeted anticancer agents, potential alternative endpoints to delineate optimal biological activity, such as plasma drug concentration and target inhibition in tumor or surrogate tissues, have been proposed along with new trial designs. We also describe specific methods for drug combinations as well as methods that use a time-to-event endpoint or both toxicity and efficacy as endpoints. Finally, we present the advantages and drawbacks of the various dose escalation methods and discuss specific applications of the methods in developmental oncotherapeutics.

Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial.

Science.gov (United States)

Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Andersen, Lars L

2017-10-10

While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1) from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 10 min 5 days per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0-100), psychosocial work environment (COPSOQ, scale 0-100), work- and leisure disability (DASH, 0-100), control- (Bournemouth, scale 0-10) and concern about pain (Pain Catastrophizing Scale, scale 0-10) were assessed at baseline and at 10-week follow-up. Vitality as well as control and concern about pain improved more following WORK than HOME (all p health remained unchanged. Between-group differences at follow-up (WORK vs. HOME) were 7 [95% confidence interval (95% CI) 3 to 10] for vitality, -0.8 [95% CI -1.3 to -0.3] for control of pain and -0.9 [95% CI -1.4 to -0.5] for concern about pain, respectively. Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.

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

NARCIS (Netherlands)

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

2009-01-01

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

Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

Directory of Open Access Journals (Sweden)

Daly Fergus

2007-03-01

Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully

Commentary (Pre-Trial Detention in the Extraordinary Chambers in the Courts of Cambodia )

DEFF Research Database (Denmark)

Marchuk, Iryna

2015-01-01

Most international criminal courts and tribunals find provisional detention absolutely necessary to ensure the swift delivery of justice. A decision on pre-trial detention must be in conformity with well-recognized human rights standards, thus respecting the person’s right to a fair trial...... and upholding the presumption of evidence. Although the general assumption in criminal law is that pre-trial detention is the exception and not the rule, a number of factors, such as the gravity of the crimes, as well as heightened flight risk of the accused, appear to have reversed the test employed...... in international criminal courts and tribunals. To date, all provisional detention orders against former members of the inner circle of Pol Pot, except for one, have been re-affirmed on appeal in the ECCC. This commentary appraises the ECCC case law on pre-trial detention from the standpoint of its conformity...

Trial type probability modulates the cost of antisaccades

Science.gov (United States)

Chiau, Hui-Yan; Tseng, Philip; Su, Jia-Han; Tzeng, Ovid J. L.; Hung, Daisy L.; Muggleton, Neil G.

2011-01-01

The antisaccade task, where eye movements are made away from a target, has been used to investigate the flexibility of cognitive control of behavior. Antisaccades usually have longer saccade latencies than prosaccades, the so-called antisaccade cost. Recent studies have shown that this antisaccade cost can be modulated by event probability. This may mean that the antisaccade cost can be reduced, or even reversed, if the probability of surrounding events favors the execution of antisaccades. The probabilities of prosaccades and antisaccades were systematically manipulated by changing the proportion of a certain type of trial in an interleaved pro/antisaccades task. We aimed to disentangle the intertwined relationship between trial type probabilities and the antisaccade cost with the ultimate goal of elucidating how probabilities of trial types modulate human flexible behaviors, as well as the characteristics of such modulation effects. To this end, we examined whether implicit trial type probability can influence saccade latencies and also manipulated the difficulty of cue discriminability to see how effects of trial type probability would change when the demand on visual perceptual analysis was high or low. A mixed-effects model was applied to the analysis to dissect the factors contributing to the modulation effects of trial type probabilities. Our results suggest that the trial type probability is one robust determinant of antisaccade cost. These findings highlight the importance of implicit probability in the flexibility of cognitive control of behavior. PMID:21543748

Body Weight Management in Adults Under Chronic Stress Through Treatment With Ashwagandha Root Extract: A Double-Blind, Randomized, Placebo-Controlled Trial.

Science.gov (United States)

Choudhary, Dnyanraj; Bhattacharyya, Sauvik; Joshi, Kedar

2017-01-01

Chronic stress has been associated with a number of illnesses, including obesity. Ashwagandha is a well-known adaptogen and known for reducing stress and anxiety in humans. The objective of this study was to evaluate the safety and efficacy of a standardized root extract of Ashwagandha through a double-blind, randomized, placebo-controlled trial. A total of 52 subjects under chronic stress received either Ashwagandha (300 mg) or placebo twice daily. Primary efficacy measures were Perceived Stress Scale and Food Cravings Questionnaire. Secondary efficacy measures were Oxford Happiness Questionnaire, Three-Factor Eating Questionnaire, serum cortisol, body weight, and body mass index. Each subject was assessed at the start and at 4 and 8 weeks. The treatment with Ashwagandha resulted in significant improvements in primary and secondary measures. Also, the extract was found to be safe and tolerable. The outcome of this study suggests that Ashwagandha root extract can be used for body weight management in adults under chronic stress. © The Author(s) 2016.

Clinical Trials

Medline Plus

Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

Clinical Trials

Medline Plus

Full Text Available ... give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Find a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

Science.gov (United States)

Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

2014-05-24

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

A Comparative Randomised Controlled Trial of the Effects of Brain Wave Vibration Training, Iyengar Yoga, and Mindfulness on Mood, Well-Being, and Salivary Cortisol

Directory of Open Access Journals (Sweden)

Deborah Bowden

2012-01-01

Full Text Available This randomised trial compared the effects of Brain Wave Vibration (BWV training, which involves rhythmic yoga-like meditative exercises, with Iyengar yoga and Mindfulness. Iyengar provided a contrast for the physical components and mindfulness for the “mental” components of BWV. 35 healthy adults completed 10 75-minute classes of BWV, Iyengar, or Mindfulness over five weeks. Participants were assessed at pre- and postintervention for mood, sleep, mindfulness, absorption, health, memory, and salivary cortisol. Better overall mood and vitality followed both BWV and Iyengar training, while the BWV group alone had improved depression and sleep latency. Mindfulness produced a comparatively greater increase in absorption. All interventions improved stress and mindfulness, while no changes occurred in health, memory, or salivary cortisol. In conclusion, increased well-being followed training in all three practices, increased absorption was specific to Mindfulness, while BWV was unique in its benefits to depression and sleep latency, warranting further research.

Description of hypo eutectic Al-Si-Cu alloys based on their known chemical compositions

International Nuclear Information System (INIS)

Djurdjevic, M. B.; Vicario, I.

2013-01-01

The modeling of casting processes has remained a topic of active interest for several decades, and the availability of numerous software packages on the market is a good indication of the interest that the casting industry has in this field. Most of the data used in these software packages are directly read or estimated from the binary or multi-component phase diagrams. Unfortunately, except for binary diagrams, many of ternary or higher order phase diagrams are still not accurate enough. Having in mind that most of the aluminum binary systems are very well established, it has been tried to transfer multi-component system into one well known Al-Xi pseudo binary system (in this case the Al-Si phase diagram was chosen as a reference system). The new Silicon Equivalency (SiEQ) algorithm expresses the amounts of major and minor alloying elements in the aluminum melts through an equivalent amount of silicon. Such a system could be used to calculate several thermo-physical and solidification characteristics of multi component as cast aluminum alloys. This provides to the model the capacity to predict the solidification characteristics of cast parts, where cooling rates are slow and the solidification process has to be known in great detail in order to avoid quality problems in the casting. This work demonstrates how the SiEQ algorithm can be used to calculate the characteristic solidification temperatures of the multicomponent Al-Si alloys as well as their latent heats and growth restriction factor. Statistical analysis of the results obtained for a wide range of alloy chemical compositions shows a very good correlation with the experimental data and the SiEQ calculations. The same mathematical approach might be applied for other metallic systems such as iron and magnesium, using carbon equivalency for ferrous systems and aluminum equivalency for magnesium multi-component alloys. (Author)

Sequential boundaries approach in clinical trials with unequal allocation ratios

Directory of Open Access Journals (Sweden)

Ayatollahi Seyyed

2006-01-01

Full Text Available Abstract Background In clinical trials, both unequal randomization design and sequential analyses have ethical and economic advantages. In the single-stage-design (SSD, however, if the sample size is not adjusted based on unequal randomization, the power of the trial will decrease, whereas with sequential analysis the power will always remain constant. Our aim was to compare sequential boundaries approach with the SSD when the allocation ratio (R was not equal. Methods We evaluated the influence of R, the ratio of the patients in experimental group to the standard group, on the statistical properties of two-sided tests, including the two-sided single triangular test (TT, double triangular test (DTT and SSD by multiple simulations. The average sample size numbers (ASNs and power (1-β were evaluated for all tests. Results Our simulation study showed that choosing R = 2 instead of R = 1 increases the sample size of SSD by 12% and the ASN of the TT and DTT by the same proportion. Moreover, when R = 2, compared to the adjusted SSD, using the TT or DTT allows to retrieve the well known reductions of ASN observed when R = 1, compared to SSD. In addition, when R = 2, compared to SSD, using the TT and DTT allows to obtain smaller reductions of ASN than when R = 1, but maintains the power of the test to its planned value. Conclusion This study indicates that when the allocation ratio is not equal among the treatment groups, sequential analysis could indeed serve as a compromise between ethicists, economists and statisticians.

Investigators' viewpoint of clinical trials in India: Past, present and future

Directory of Open Access Journals (Sweden)

Mohandas K Mallath

2017-01-01

Full Text Available India's success in producing food and milk for its population (Green Revolution and White Revolution happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials.

Analysis of PWR auxiliary coolant: determination of chloride in borax/nitrite solution by known addition - known dilution potentiometry

International Nuclear Information System (INIS)

Midgley, D.; Gatford, C.

1989-11-01

Chloride concentrations of 75-250 μg 1 -1 have been determined in simulated PWR auxiliary coolant containing 1000 mg l -1 each of sodium tetraborate and sodium nitrite. The effects of the two main components of the coolant solution on a variety of chloride-selective electrodes have been studied. Sodium tetraborate posed no problem except through its effect on the pH, which is easily adjusted. Such high concentrations of nitrite, however, caused significant deviations in e.m.f. for all the electrodes and marked tarnishing of the electroactive membrane after only one or two measurements. Sulphamic acid was selected as the best means of removing nitrite and silver chloride electrodes were preferred over mercury(I) chloride electrodes because of their greater robustness in the conditions. At these chloride concentrations, the electrodes are operating in their non-Nernstian response regions and direct potentiometry has poor precision, even if standards could be successfully matched to samples containing such high concentrations of background material. Known addition - known dilution potentiometry was adopted, with internal calibration for both slope factor and standard potential. (author)

The gait and balance of patients with diabetes can be improved: a randomised controlled trial.

NARCIS (Netherlands)

Allet, L.; Armand, S.; Bie, R.A. de; Golay, A.; Monnin, D.; Aminian, K.; Staal, J.B.; Bruin, E.D. de

2010-01-01

AIMS/HYPOTHESIS: Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. METHODS: This was a randomised controlled trial (n=71)

Efficacy of the Fun For Wellness Online Intervention to Promote Well-Being Actions: A Secondary Data Analysis.

Science.gov (United States)

Myers, Nicholas D; Dietz, Samantha; Prilleltensky, Isaac; Prilleltensky, Ora; McMahon, Adam; Rubenstein, Carolyn L; Lee, Seungmin

2018-04-30

Fun For Wellness (FFW) is a new online intervention designed to promote growth in well-being by providing capability-enhancing learning opportunities (e.g., play an interactive game) to participants. The purpose of this study was to provide an initial evaluation of the efficacy of the FFW intervention to increase well-being actions. The study design was a secondary data analysis of a large-scale prospective, double-blind, parallel-group randomized controlled trial. Data were collected at baseline and 30 and 60 days postbaseline. A total of 479 adult employees at a major university in the southeast of the United States of America were enrolled. Participants who were randomly assigned to the FFW group were provided with 30 days of 24-hour access to the intervention. A two-class linear regression model with complier average causal effect estimation was fitted to well-being actions scores at 30 and 60 days. Intent-to-treat analysis provided evidence that the effect of being assigned to the FFW intervention, without considering actual participation in the FFW intervention, had a null effect on each dimension of well-being actions at 30 and 60 days. Participants who complied with the FFW intervention, however, had significantly higher well-being actions scores, compared to potential compliers in the Usual Care group, in the interpersonal dimension at 60 days, and the physical dimension at 30 days. Results from this secondary data analysis provide some supportive evidence for both the efficacy of and possible revisions to the FFW intervention in regard to promoting well-being actions.

Managing clinical trials

Directory of Open Access Journals (Sweden)

Kenyon Sara

2010-07-01

Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

Cell therapy in dilated cardiomyopathy: from animal models to clinical trials

Directory of Open Access Journals (Sweden)

C. del Corsso

2011-05-01

Full Text Available Dilated cardiomyopathy can be the end-stage form and common denominator of several cardiac disorders of known cause, such as hypertensive, ischemic, diabetic and Chagasic diseases. However, some individuals have clinical findings, such as an increase in ventricular chamber size and impaired contractility (classical manifestations of dilated cardiomyopathy even in the absence of a diagnosed primary disease. In these patients, dilated cardiomyopathy is classified as idiopathic since its etiology is obscure. Nevertheless, regardless of all of the advances in medical, pharmacological and surgical procedures, the fate of patients with dilated cardiomyopathy (of idiopathic or of any other known cause is linked to arrhythmic episodes, severe congestive heart failure and an increased risk of sudden cardiac death. In this review, we will summarize present data on the use of cell therapies in animal models of dilated cardiomyopathies and will discuss the few clinical trials that have been published so far involving patients affected by this disease. The animal models discussed here include those in which the cardiomyopathy is produced by genetic manipulation and those in which disease is induced by chemical or infectious agents. The specific model used clearly creates restrictions to translation of the proposed cell therapy to clinical practice, insofar as most of the clinical trials performed to date with cell therapy have used autologous cells. Thus, translation of genetic models of dilated cardiomyopathy may have to wait until the use of allogeneic cells becomes more widespread in clinical trials of cell therapies for cardiac diseases.

Clinical Trials

Medline Plus

Full Text Available ... more screening tests to see which test produces the best results. Some companies and groups sponsor clinical trials that test the ... and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

Detailed statistical analysis plan for the target temperature management after out-of-hospital cardiac arrest trial

DEFF Research Database (Denmark)

Nielsen, Niklas; Winkel, Per; Cronberg, Tobias

2013-01-01

Animal experimental studies and previous randomized trials suggest an improvement in mortality and neurological function with temperature regulation to hypothermia after cardiac arrest. According to a systematic review, previous trials were small, had a risk of bias, evaluated select populations......, and did not treat hyperthermia in the control groups. The optimal target temperature management (TTM) strategy is not known. To prevent outcome reporting bias, selective reporting and data-driven results, we present the a priori defined detailed statistical analysis plan as an update to the previously...

Capturing effort and recovery: reactive and recuperative cortisol responses to competition in well-trained rowers

NARCIS (Netherlands)

Kallen, V.L.; Stubbe, J.H.; Zwolle, H.J.; Valk, P.

2017-01-01

Background/aim It is well known that physical strain is associated with increased cortisol production. And although mental stress elevates cortisol concentrations as well, little is known of the independent and/or combined effects of both on the secretion of cortisol. Aim of the study was to

Heretic or rebel? The heresy trial of Albert Geyser

Directory of Open Access Journals (Sweden)

Wim Dreyer

2016-11-01

Full Text Available During September 1961, a charge of heresy was laid against New Testament scholar and antiapartheid activist Prof. A.S. (Albert Geyser. The charge was brought by three senior theological students of the University of Pretoria. They accused Geyser of interpreting Philippians 2 in such a way that it undermined the church’s doctrine of Christ’s pre-existence. The heresy trial started on 24 October 1961 under massive public interest. The trial lasted 6 months and the proceedings covered 2672 typed pages. Reporters of 25 national and international newspapers attended the trial. The heresy trial caused widespread international condemnation of what was regarded as an orchestrated attempt to get rid of Geyser, because of his public and radical opposition to apartheid. In this contribution, Geyser’s theological critique of apartheid as well as his conviction of heresy is discussed. The proceedings of the trial, minutes of the moderature, media coverage and Geyser’s publications serve as primary sources. It concludes with a critical evaluation of Geyser’s theology and his role as a public theologian.

Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation.

Science.gov (United States)

Merali, Zamir; Wilson, Jefferson R

2017-11-01

Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factors determined at the design phase of the trial including eligibility criteria, study setting, and outcomes of interest. In general, explanatory trials are optimized to demonstrate the efficacy of an intervention in a highly selected patient group; however, findings from these studies may not be generalizable to the larger clinical problem. In contrast, pragmatic trials attempt to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. In this article we describe the explanatory-pragmatic continuum for clinical trials in greater detail. Further, a well-accepted tool for grading trials on this continuum is described, and applied, to 2 recently published trials pertaining to the surgical management of lumbar degenerative spondylolisthesis.

Clinical Trials

Medline Plus

Full Text Available ... resources to the strategies and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking part in a clinical trial is different ...

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial.

Science.gov (United States)

Overgaard, Hans J; Alexander, Neal; Mátiz, Maria Ines; Jaramillo, Juan Felipe; Olano, Victor Alberto; Vargas, Sandra; Sarmiento, Diana; Lenhart, Audrey; Seidu, Razak; Stenström, Thor Axel

2012-10-03

Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation. This is the first trial

Nonconsensual clinical trials: a foreseeable risk of offshoring under global corporatism.

Science.gov (United States)

Spielman, Bethany

2015-03-01

This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.

A.D.XENOPOL, A LESS KNOWN ECONOMIST

Directory of Open Access Journals (Sweden)

STEFANESCU FLORICA

2009-05-01

Full Text Available Outstanding Romanian man of culture in the second half of the XIXa€™th century, known as remarkable historian, A.D.Xenopol was also a genuine economist, preoccupied not only by the theory but also by the practice of economics. I have achieved an investig

Clinical Trials

Medline Plus

Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

Clinical Trials

Medline Plus

Full Text Available ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the ... more about, or taking part in, clinical trials, talk with your doctor. He or she may know about ... clinical trials. NIH Clinical Research Studies ...

Selective serotonin reuptake inhibitors (SSRIs) for post-partum depression (PPD): a systematic review of randomized clinical trials.

Science.gov (United States)

De Crescenzo, Franco; Perelli, Federica; Armando, Marco; Vicari, Stefano

2014-01-01

The treatment of postpartum depression with selective serotonin reuptake inhibitors (SSRIs) has been claimed to be both efficacious and well tolerated, but no recent systematic reviews have been conducted. A qualitative systematic review of randomized clinical trials on women with postpartum depression comparing SSRIs to placebo and/or other treatments was performed. A comprehensive literature search of online databases, the bibliographies of published articles and grey literature were conducted. Data on efficacy, acceptability and tolerability were extracted and the quality of the trials was assessed. Six randomised clinical trials, comprising 595 patients, met quality criteria for inclusion in the analysis. Cognitive-behavioural intervention, psychosocial community-based intervention, psychodynamic therapy, cognitive behavioural therapy, a second-generation tricyclic antidepressant and placebo were used as comparisons. All studies demonstrated higher response and remission rates among those treated with SSRIs and greater mean changes on depression scales, although findings were not always statistically significant. Dropout rates were high in three of the trials but similar among treatment and comparison groups. In general, SSRIs were well tolerated and trial quality was good. There are few trials, patients included in the trials were not representative of all patients with postpartum depression, dropout rates in three trials were high, and long-term efficacy and tolerability were assessed in only two trials. SSRIs appear to be efficacious and well tolerated in the treatment of postpartum depression, but the available evidence fails to demonstrate a clear superiority over other treatments. © 2013 Elsevier B.V. All rights reserved.

The Hi Five study: design of a school-based randomized trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark.

Science.gov (United States)

Johansen, Anette; Denbæk, Anne Maj; Bonnesen, Camilla Thørring; Due, Pernille

2015-03-01

Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children. Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses. However, most of these studies include small populations and almost none of them are conducted as randomized controlled trials. The overall aim of the Hi Five study was to develop, implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20% compared to control schools. This paper describes the development and the evaluation design of Hi Five. The Hi Five study was designed as a tree-armed cluster-randomized controlled trial. A national random sample of schools (n = 44) was randomized to one of two intervention groups (n = 29) or to a control group with no intervention (n = 15). A total of 8,438 six to fifteen-year-old school children were enrolled in the study. The Hi Five intervention consisted of three components: 1) a curriculum component 2) mandatory daily hand washing before lunch 3) extra cleaning of school toilets during the school day. Baseline data was collected from December 2011 to April 2012. The intervention period was August 2012 to June 2013. The follow-up data was collected from December 2012 to April 2013. The Hi Five study fills a gap in international research. This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum. No previous studies have involved supplementary cleaning at the school toilets as an intervention component. The study will have the added value of providing new knowledge about usability of short message service (SMS, text message) for collecting data on infectious illness and absenteeism in large study populations. Current Controlled

Developing a survey of barriers and facilitators to recruitment in randomized controlled trials

Directory of Open Access Journals (Sweden)

Kaur Geetinder

2012-11-01

Full Text Available Abstract Background Recruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire. Methods A literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i trial, (ii site, (iii patient, (iv clinical team, (v information and consent and (vi study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment. Results A web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes. Conclusions We have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using

Brominated Dioxins: Little-Known New Health Hazards - A Review

Directory of Open Access Journals (Sweden)

Piskorska-Pliszczyńska Jadwiga

2014-10-01

Full Text Available This article reviews the present state of the science concerning the polybrominated dibenzo-p-dioxins (PBDDs and dibenzofurans (PBDFs. Everywhere in the world people are exposed to anthropogenic origin chemicals. Some of them are long-lived organic compounds, which persist over the years in the environment. Persistent organic pollutants, such as organohalogen compounds, accumulate in environmental and biological compartments and have adverse effects on the health of humans and animals. Little is known about the brominated and mixed chloro/bromo dioxin and furans. Existing literature suggests that brominated dioxins and furans have similar toxicity profiles to their chlorinated analogues. The exposure data are extremely limited, showing a major data gap in estimating the potential environmental and health risk of these chemicals. The rapid increase in the use of brominated flame retardants (the main source of these pollutants has raised the level of concern over environmental and health damage from brominated dioxins and furans. It is likely that human as well as wildlife exposure to these contaminants will increase with their greater use. The findings reported here present strong evidence of the PBDDs and PBDFs as an emerging new class of contaminants.

Poloidal field coil design for known plasma equilibrium states

International Nuclear Information System (INIS)

Paulson, C.C.; Todd, A.M.M.; Reusch, M.F.

1986-01-01

The technique for obtaining plasma equilibria with given boundary conditions has long been known and understood. The inverse problem of obtaining a poloidal field (PF) coil system from a given plasma equilibrium has been widely studied, however its solution has remained largely an art form. An investigation, by the writers, of this fundamentally ill-posed inverse problem has resulted in a new understanding of the requirements that solutions must satisfy. A set of interacting computer codes has been written which may be used to successfully design PF coil systems capable of supporting given plasma equilibria. It is shown that for discrete coil systems with a reasonable number of elements the standard minimization of the R M S flux error can lead to undesirable results. Examples are given to show that an additional stability requirement must be imposed on the regularization parameter to obtain correct solutions. For some equilibria, the authors find that the inverse problem admits dual solutions corresponding to two possible magnetic field configurations that fit the constraining relations on the plasma surface equally well. An additional minimization of the absolute value of the limiter flux is required to discriminate between these solutions

SARCOPENIA: DESIGNING PHASE IIB TRIALS

Science.gov (United States)

CHUMLEA, WM.C.; CESARI, M.; EVANS, W.J.; FERRUCCI, L.; FIELDING, R.A.; PAHOR, M.; STUDENSKI, S.; VELLAS, B.

2012-01-01

Sarcopenia is the age-related involuntary loss of skeletal muscle mass and functionality that can lead to the development of disability, frailty and increased health care costs. The development of interventions aimed at preventing and/or treating sarcopenia is complex, requiring the adoption of assumptions and standards that are not well established scientifically or clinically. A number of investigators and clinicians (both from academia and industry) met in Rome (Italy) in 2009 to develop a consensus definition of sarcopenia. Subsequently, in Albuquerque (New Mexico, USA) in 2010, the same group met again to consider the complex issues necessary for designing Phase II clinical trials for sarcopenia. Current clinical trial data indicate that fat-free mass (FFM) parameters are responsive to physical activity/nutritional treatment modalities over short time periods, but pharmacological trials of sarcopenia have yet to show significant efficacy. In order to conduct a clinical trial within a reasonable time frame, groups that model or display accelerated aging and loss of FFM are necessary. Few studies have used acceptable designs for testing treatment effects, sample sizes or primary outcomes that could provide interpretable findings or effects across studies. Dual energy x ray absorptiometry (DXA) is the measure of choice for assessing FFM, but sufficient time is needed for changes to be detected accurately and reliably. A tool set that would allow clinical, basic and epidemiological research on sarcopenia to advance rapidly toward diagnosis and treatment phases should be those reflecting function and strength. PMID:21623466

Prospective registration of clinical trials in India: strategies, achievements & challenges.

Science.gov (United States)

Tharyan, Prathap

2009-02-01

This paper traces the development of the Clinical Trial Registry-India (CTRI) against the backdrop of the inequities in healthcare and the limitations in the design, conduct, regulation, oversight and reporting of clinical trials in India. It describes the scope and goals of the CTRI, the data elements it seeks and the process of registering clinical trials. It reports progress in trial registration in India and discusses the challenges in ensuring that healthcare decisions are informed by all the evidence. A descriptive survey of developments in clinical trial registration in India from publications in the Indian medical literature supplemented by first hand knowledge of these developments and an evaluation of how well clinical trials registered in the CTRI up to 10 January, 2009 comply with the requirements of the CTRI and the World Health Organization's International Clinical Trial Registry (WHO ICTRP). Considerable inequities exist within the Indian health system. Deficiencies in healthcare provision and uneven regulation of, and access to, affordable healthcare co-exists with a large private health system of uneven quality. India is now a preferred destination for outsourced clinical trials but is plagued by poor ethical oversight of the many trial sites and scant information of their existence. The CTRI's vision of conforming to international requirements for transparency and accountability but also using trial registration as a means of improving trial design, conduct and reporting led to the selection of registry-specific dataset items in addition to those endorsed by the WHO ICTRP. Compliance with these requirements is good for the trials currently registered but these trials represent only a fraction of the trials in progress in India. Prospective trial registration is a reality in India. The challenges facing the CTRI include better engagement with key stakeholders to ensure increased prospective registration of clinical trials and utilization of

78 FR 48539 - Designation of Bahawal Khan, Also Known as Salahuddin Ayubi, Also Known as Bahwal Khan, as a...

Science.gov (United States)

2013-08-08

... DEPARTMENT OF STATE [Public Notice 8415] Designation of Bahawal Khan, Also Known as Salahuddin... committing, acts of terrorism that threaten the security of U.S. nationals or the national security, foreign policy, or economy of the United States. Consistent with the determination in section 10 of Executive...

Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial

Directory of Open Access Journals (Sweden)

Capozzi Lauren C

2012-10-01

Full Text Available Abstract Background Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck (HN cancer populations. This translates into a lack of clinical programming available for these patient populations. HN cancer patients deal with severe weight loss, with more than 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL, and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Our pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Methods/Design Therefore, the purpose of the present study is to examine the impact and timing of a 12-week PA and nutrition intervention (either during or following treatment for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, we will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects, as well as return to work. Discussion This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical-activity and wellness-education model that can be implemented in other cancer centers. Trial registration Current Controlled Trials NCT01681654

On Unrooted and Root-Uncertain Variants of Several Well-Known Phylogenetic Network Problems

NARCIS (Netherlands)

van Iersel, L.J.J.; Kelk, Steven; Stougie, Leen; Boes, Olivier

2017-01-01

The hybridization number problem requires us to embed a set of binary rooted phylogenetic trees into a binary rooted phylogenetic network such that the number of nodes with indegree two is minimized. However, from a biological point of view accurately inferring the root location in a phylogenetic

A Journey Along some Well-Known Curves -R-ES-ONANCEI--Ma-rc-h

Indian Academy of Sciences (India)

Figure 1. Cycloid. GENERAL I ARTICLE world Acta eruditorum started .... Pietro encouraged his daughter in learning science and for that purpose regularly ... mastered the technique of solving difficult problems of analytical geometry and ...

Synopsis of the plants known as medicinal and poisonous in Northeast of Brazil

Directory of Open Access Journals (Sweden)

Maria de Fátima Agra

Full Text Available The objective of this work is a survey of the species of plants and their alleged therapeutic uses which are utilized in Northeast region of Brazil. The area of this study is well known for its rich diversity of species of plants and habitats, which range from rainforest, atlantic forest, coastal dunes systems and mangroves, to dry forests and savannas. A total of 483 species belonging to 79 families along with their ethnomedicinal information have been recorded. This study aims at emphasizing the greatest importance of investigating those species of plants which have not been the subject of any pharmacological study, although their popular uses have been reported.

78 FR 13931 - Designation of Malang Wazir, Also Known as Wali Mohammed, Also Known as Malang Jan, as a...

Science.gov (United States)

2013-03-01

... DEPARTMENT OF STATE [Public Notice 8210] Designation of Malang Wazir, Also Known as Wali Mohammed..., acts of terrorism that threaten the security of U.S. nationals or the national security, foreign policy, or economy of the United States. Consistent with the determination in section 10 of Executive Order...

Racial and ethnic minority enrollment in randomized clinical trials of behavioural weight loss utilizing technology: a systematic review.

Science.gov (United States)

Rosenbaum, D L; Piers, A D; Schumacher, L M; Kase, C A; Butryn, M L

2017-07-01

Many racial and ethnic minority groups (minorities) are disproportionately affected by overweight and obesity; however, minorities are often under-represented in clinical trials of behavioural weight loss (BWL) treatment, potentially limiting the generalizability of these trials' conclusions. Interventions involving technology may be particularly well suited to overcoming the barriers to minority enrollment in BWL trials, such as demanding or unpredictable work schedules, caregiving responsibilities and travel burdens. Thus, this systematic review aimed to describe minority enrollment in trials utilizing technology in interventions, as well as to identify which form(s) of technology yield the highest minority enrollment. Results indicated relatively low enrollment of minorities. Trials integrating smartphone use exhibited significantly greater racial minority enrollment than trials that did not; trials with both smartphone and in-person components exhibited the highest racial minority enrollment. This review is the first to explore how the inclusion of technology in BWL trials relates to minority enrollment and can help address the need to improve minority enrollment in weight loss research. © 2017 World Obesity Federation.

Improving Clinical Trial Efficiency: Thinking outside the Box.

Science.gov (United States)

Mandrekar, Sumithra J; Dahlberg, Suzanne E; Simon, Richard

2015-01-01

Clinical trial design strategies have evolved over the past few years as a means to accelerate the drug development process so that the right therapies can be delivered to the right patients. Basket, umbrella, and adaptive enrichment strategies represent a class of novel designs for testing targeted therapeutics in oncology. Umbrella trials include a central infrastructure for screening and identification of patients, and focus on a single tumor type or histology with multiple subtrials, each testing a targeted therapy within a molecularly defined subset. Basket trial designs offer the possibility to include multiple molecularly defined subpopulations, often across histology or tumor types, but included in one cohesive design to evaluate the targeted therapy in question. Adaptive enrichment designs offer the potential to enrich for patients with a particular molecular feature that is predictive of benefit for the test treatment based on accumulating evidence from the trial. This review will aim to discuss the fundamentals of these design strategies, the underlying statistical framework, the logistical barriers of implementation, and, ultimately, the interpretation of the trial results. New statistical approaches, extensive multidisciplinary collaboration, and state of the art data capture technologies are needed to implement these strategies in practice. Logistical challenges to implementation arising from centralized assay testing, requirement of multiple specimens, multidisciplinary collaboration, and infrastructure requirements will also be discussed. This review will present these concepts in the context of the National Cancer Institute's precision medicine initiative trials: MATCH, ALCHEMIST, Lung MAP, as well as other trials such as FOCUS4.

Impact of the ALMS and MAINTAIN trials on the management of lupus nephritis.

Science.gov (United States)

Morris, Heather K; Canetta, Pietro A; Appel, Gerald B

2013-06-01

Current treatment of lupus nephritis consists of both induction and maintenance therapy, with the latter being designed to consolidate remissions and prevent relapses. Long-term maintenance treatment with intravenous cyclophosphamide was effective but associated with considerable toxicity. A small but well-designed controlled trial found that for post-induction maintenance therapy, both oral mycophenolate mofetil (MMF) and oral azathioprine were superior in efficacy and had reduced toxicity than a regimen of continued every third month intravenous cyclophosphamide. Although these oral agents were rapidly accepted and utilized as maintenance medications, their usage was based on scant evidence and there were no comparisons between the two. Recently, two relatively large, randomized, well-controlled, multicenter trials dealing with maintenance therapy for severe lupus nephritis have been completed. The Aspreva Lupus Management Study (ALMS) maintenance and MAINTAIN nephritis trials provide important information regarding the comparative efficacy and safety of MMF and azathioprine as maintenance therapies, as well as information on the effect of dosage and duration of treatment with these agents.

Well-being therapy in depression: New insights into the role of psychological well-being in the clinical process.

Science.gov (United States)

Fava, Giovanni A; Cosci, Fiammetta; Guidi, Jenny; Tomba, Elena

2017-09-01

A specific psychotherapeutic strategy for increasing psychological well-being and resilience, well-being therapy (WBT), has been developed and validated in a number of randomized controlled trials. The findings indicate that flourishing and resilience can be promoted by specific interventions leading to a positive evaluation of one's self, a sense of continued growth and development, the belief that life is purposeful and meaningful, the possession of quality relations with others, the capacity to manage effectively one's life, and a sense of self-determination. The evidence supporting the use of WBT and its specific contribution when it is combined with other psychotherapeutic techniques is still limited. However, the insights gained by the use of WBT may unravel innovative approaches to assessment and treatment of mood and anxiety disorders, to be confirmed by controlled studies, with particular reference to decreasing vulnerability to relapse and modulating psychological well-being and mood. An important characteristic of WBT is self-observation of psychological well-being associated with specific homework. Such perspective is different from interventions that are labeled as positive but are actually distress oriented. Another important feature of WBT is the assumption that imbalances in well-being and distress may vary from one illness to another and from patient to patient. Customary clinical taxonomy and evaluation do not include psychological well-being, which may demarcate major prognostic and therapeutic differences among patients who otherwise seem to be deceptively similar since they share the same diagnosis. © 2017 Wiley Periodicals, Inc.

Study of condensate removal from wells

Energy Technology Data Exchange (ETDEWEB)

Gusein-Zade, Z I

1967-01-01

A pressure profile of well No. 218 in the Karadag condensate field showed that pressure did not vary linearly with depth. Calculations indicated that at depths of 3,000-3,640 m, produced fluid had a density of 0.29g/ cmU3D, whereas pure condensate gas should have a density of 0.11g/cmU3D. Apparently liquid was accumulating in the well. Other data showed that gas velocity in the well at various depths varied from 6 to 11 m/sec. It was also found that this same range of gas velocities was sufficient to prevent liquid accumulation in other wells. In an effort to solve this problem, the upward flow of gas-water and of gas-condensate mixtures in tubes was studied. Each had a different flow regime. Gas-condsensate formed foam, whereas the gas-water mixture did not. This resolved the problem, since foam is known to aid the removal of liquid by gas. Additional research showed that water was present in, and promoted accumulation of, liquid in well No. 218.

"I will miss the study, God bless you all": participation in a nutritional chemoprevention trial.

Science.gov (United States)

Moreno-Black, Geraldine; Shor-Posner, Gail; Miguez, Maria-Jose; Burbano, Ximena; O'Mellan, Sandra; Yovanoff, P

2004-01-01

Randomized controlled clinical trials are often considered to be the "gold standard" for health research. Consequently, understanding the reasons people participate in these trials, especially minority groups who are often under-represented in clinical trials, or populations who have chronic illnesses or abuse drugs, is salient for successful recruitment, retention, and project design. This paper describes the results of a study that was designed to examine some of the ways in which participants in a randomized double blind clinical trial perceived their participation in the clinical trial, and the reasons they gave for continuing in the study. All of the participants were individuals who were using drugs and were infected with the HIV-1 virus, and had participated in a chemoprevention trial. The data from an exit interview were analyzed thematically in order to reveal units of meaning concerning participation and continuation in the clinical trial. The analysis revealed 3 higher-level concepts, or themes, that guided participation: increased health awareness, personal enhancement, and sociability. The data clearly indicated that involvement and retention in the trial were directly related to the ways in which the participants interpreted the study, perceived the benefits they derived from participating, and imbued their participation with value so that it was important and relevant to their own perceptions of health, as well as personal and social well being.

On calculation of a steam-water flow in a geothermal well

Science.gov (United States)

Shulyupin, A. N.; Chermoshentseva, A. A.

2013-08-01

Approaches to calculation of a steam-water flow in a geothermal well are considered. For hydraulic applications, a WELL-4 model of a steam-water well is developed. Data obtained using this model are compared with experimental data and also with calculations by similar models including the well-known HOLA model. The capacity of the A-2 well in the Mutnovskoe flash-steam field (Kamchatka half-island, Russia) after planned reconstruction is predicted.

Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials

Science.gov (United States)

da Silva, Ricardo E.; Amato, Angélica A.; Guilhem, Dirce B.; de Carvalho, Marta R.; Lima, Elisangela da C.; Novaes, Maria Rita C. G.

2018-01-01

Background: Although policies and guidelines make use of the concept of vulnerability, few define it. The European Union's directive for clinical trials does not include explanations for or the reasoning behind the designation of certain groups as vulnerable. Emerging economies from lower middle-income countries have, in recent years, had the largest average annual growth rate, as well as increase, in number of clinical trials registered in the US government's database. Nevertheless, careful supervision of research activities has to be ensured. Objective: To describe and analyze the features of the clinical trials involving vulnerable populations in various countries classified by development status and geographic region. Methods: Retrospective study that involved analysis of data obtained from the International Clinical Trials Registry Platform (ICTRP) database between 01/2014 and 12/2014 from countries with (i) highest trial densities during 2005 to 2012, (ii) highest average growth rate in clinical trials, and (iii) greatest trial capabilities. Results: Statistical analysis of this study showed that patients incapable of giving consent personally are 11.4 times more likely to be vulnerable patients than patients who are capable, and that patients in upper-middle-income countries are 1.7 times more likely to be vulnerable patients than patients from high-income countries when participating in global clinical trials. Malaysia (21%), Egypt (20%), Turkey (19%), Israel (18%), and Brazil (17%) had the highest percentages of vulnerable populations involving children. Conclusions: Although the inability to provide consent personally was a factor associated with vulnerability, arbitrary criteria may have been considered when classifying the populations of clinical trials as vulnerable. The EU Clinical Trials Register should provide guidance regarding exactly what aspects or factors should be taken into account to frame given populations as vulnerable, because

Microbial removal of weathered hydrocarbons by well adapted ...

African Journals Online (AJOL)

ELSA

2013-02-27

Feb 27, 2013 ... It is well known that light oil fractions are the first to evaporate so .... flame ionization detector (GC-FID), where 1 µl was injected into an. Agilent 6850 ... in the signal. ..... 1), weak symmetric stretch C=C-C=C (1640 cm-1), C=C.

Timely and complete publication of economic evaluations alongside randomized controlled trials.

Science.gov (United States)

Thorn, Joanna C; Noble, Sian M; Hollingworth, William

2013-01-01

Little is known about the extent and nature of publication bias in economic evaluations. Our objective was to determine whether economic evaluations are subject to publication bias by considering whether economic data are as likely to be reported, and reported as promptly, as effectiveness data. Trials that intended to conduct an economic analysis and ended before 2008 were identified in the International Standard Randomised Controlled Trial Number (ISRCTN) register; a random sample of 100 trials was retrieved. Fifty comparator trials were randomly drawn from those not identified as intending to conduct an economic study. The trial start and end dates, estimated sample size and funder type were extracted. For trials planning economic evaluations, effectiveness and economic publications were sought; publication dates and journal impact factors were extracted. Effectiveness abstracts were assessed for whether they reached a firm conclusion that one intervention was most effective. Primary investigators were contacted about reasons for non-publication of results, or reasons for differential publication strategies for effectiveness and economic results. Trials planning an economic study were more likely to be funded by government (p = 0.01) and larger (p = 0.003) than other trials. The trials planning an economic evaluation had a mean of 6.5 (range 2.7-13.2) years since the trial end in which to publish their results. Effectiveness results were reported by 70 %, while only 43 % published economic evaluations (p economic results included the intervention being ineffective, and staffing issues. Funding source, time since trial end and length of study were not associated with a higher probability of publishing the economic evaluation. However, studies that were small or of unknown size were significantly less likely to publish economic evaluations than large studies (p journal impact factor was 1.6 points higher for effectiveness publications than for the

The New Legal Framework for Acquiring ‘Well-Known’ Status in China

DEFF Research Database (Denmark)

Xiao, Kaiyu; Barrett Christiansen, Claus; Elsmore, Matthew James

2017-01-01

In China there is a new legal framework governing the determination of ‘well-known’ trade mark status. In this article, we identify several substantive and procedural innovations as regards the new rules, as well as drawing attention to attendant Chinese peculiarities that are also worthy...... of attention. Our legal analysis comprises a mix of positive and constructive critique of current Chinese trade mark law and practice, and reveals that to understand the rules regarding well-known status demands close examination of the institutional set-up in China. The article’s aim is to detail the new...... provisions and to address whether the new legal framework signals, overall, a more coherent phase of Chinese trade mark law ahead for determining and concluding well-known trade mark status in China....

The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

Science.gov (United States)

Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

2016-01-28

Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

STEPS: A NARRATIVE ACCOUNT OF A GABAPENTIN SEEDING TRIAL

Science.gov (United States)

Krumholz, Samuel D.; Egilman, David S.; Ross, Joseph S.

2012-01-01

Background Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail. Methods We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) produced during the Neurontin marketing, sales practices and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing v. Pfizer and Franklin v. Warner-Lambert, the majority of which were created between 1990 and 2009. Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial, in order to identify key themes related to the trial’s conduct and determine the extent of marketing involvement in its planning and implementation. Results Documents demonstrated that STEPS was a seeding trial posing as a legitimate scientific study. Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company’s marketing plans. Documents demonstrated that several external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association. None of these findings were reported in two published papers. Conclusions The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation. PMID:21709111

[How to prevent hazards and to reduce risk in clinical trials?].

Science.gov (United States)

Czarkowski, Marek

2008-12-01

Different stakeholders involved in clinical trials are exposed to hazards related with this biomedical research. Beside clinical trials participants other important stakeholders are: investigators, sponsors, centers and clinical research organizations. Hazard prevention needs effective methods of hazard disclosure and analysis. A reduction of risks related with clinical trials is possible due to education, training, inspections, research discipline and penalties. Effective ways of hazard elimination or hazard reduction should be developed as well. Education and training should be offered to all stakeholders but their forms and contents should be adapted to different types of stakeholders. Direct control of the clinical trials should be held by stakeholders conducting clinical trials and outside inspections should be done by other institutions like clinical research organizations, research ethics committees and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Serious oversight is an absence of any independent inspection during a phase of publication of clinical trial results. We should not accept any exception from the golden rule that results of all clinical trials must be published. Indemnity for damages is a popular way of compensation for clinical trials participants. Investigators, sponsors and centers should have valid liability insurance. Drastic measures for reduction of risks in clinical trials are different kinds of penalties. They should prevent participation of unreliable stakeholders and promote those who respect regulations and high ethical standards.

Constructing new APN functions from known ones

DEFF Research Database (Denmark)

Budaghyan, L.; Carlet, C.; Leander, Gregor

2009-01-01

We present a method for constructing new quadratic APN functions from known ones. Applying this method to the Gold power functions we construct an APN function x(3) + tr(x(9)) over F2(n). It is proven that for n >= 7 this function is CCZ-inequivalent to the Gold functions, and in the case n = 7...