Full Text Available Abstract Background The purpose of this study was to demonstrate how formative program process evaluation was used to improve dose and fidelity of implementation, as well as reach of the intervention into the target population, in the "Active by Choice Today" (ACT randomized school-based trial from years 1 to 3 of implementation. Methods The intervention integrated constructs from Self-Determination Theory and Social Cognitive Theory to enhance intrinsic motivation and behavioral skills for increasing long-term physical activity (PA behavior in underserved adolescents (low income, minorities. ACT formative process data were examined at the end of each year to provide timely, corrective feedback to keep the intervention "on track". Results Between years 1 and 2 and years 2 and 3, three significant changes were made to attempt to increase dose and fidelity rates in the program delivery and participant attendance (reach. These changes included expanding the staff training, reformatting the intervention manual, and developing a tracking system for contacting parents of students who were not attending the after-school programs regularly. Process outcomes suggest that these efforts resulted in notable improvements in attendance, dose, and fidelity of intervention implementation from years 1 to 2 and 2 to 3 of the ACT trial. Conclusion Process evaluation methods, particularly implementation monitoring, are useful tools to ensure fidelity in intervention trials and for identifying key best practices for intervention delivery.
identify and locate the experiments of POEX65 as acts; and to ask the questions: what constitutes those acts as experiments? and how do we possibly archive them? My purpose, then, is to define the methodologies to obtain the contours of a post-phenomenology of experimental artistic production in order to...... be able to analyse the phenomena found at POEX65. Here I will use the notion of the ‘ontological theatre’ (Pickering), which, according to Pickering, is acted out in experimental art productions. The experiment could thus be seen as an ‘agency-realism’ – as an ‘act’ of relations across the aesthetics...
Full Text Available Abstract Background As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Discussion Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Summary Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future
Kraus, M. [Price Waterhouse Coopers, Berlin (Germany)
The new German Energy Act has been in force since April this year, but competition has been slow to develop so far. New alliances and joint ventures are being formed to exploit the new freedoms that the Law brings, but the structures needed to operate competition are still being built. The question many are asking is whether an electricity exchange can bring the breakthrough? (Author)
Bader, James D.; Vollmer, William M.; Shugars, Daniel A.; Gilbert, Gregg H.; Amaechi, Bennett T.; Brown, John P.; Laws, Reesa L.; Funkhouser, Kimberly A.; Makhija, Sonia K.; Ritter, André V.; Leo, Michael C.
Background Although caries is prevalent in adults, few preventive therapies have been tested in adult populations. This randomized clinical trial evaluated the effectiveness of xylitol lozenges in preventing caries in elevated caries-risk adults. Methods X-ACT was a three-site placebo-controlled randomized trial. Participants (n=691) ages 21–80 consumed five 1.0 g xylitol or placebo lozenges daily for 33 months. Clinical examinations occurred at baseline, 12, 24 and 33 months. Results Xylitol lozenges reduced the caries increment 11%. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. Conclusions Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among elevated caries-risk adults. Clinical Implications These results suggest that xylitol used as a supplement in adults does not significantly reduce their caries experience. PMID:23283923
Signal detection theory has been well accepted in vision science to measure human sensitivity to stimuli in a Psychophysical experiment. The theory is formulated so that the measured sensitivity is independent from a response bias (criterion). The formulation is based on an assumption that number of trials in the experiment is infinite but this assumption cannot be satisfied in practice. The assumption came from two normal distributions used in the formulation. The distributions respectively ...
Background Dental caries incidence in adults is similar to that in children and adolescents, but few caries preventive agents have been evaluated for effectiveness in adults populations. In addition, dentists direct fewer preventive services to their adult patients. Xylitol, an over-the-counter sweetener, has shown some potential as a caries preventive agent, but the evidence for its effectiveness is not yet conclusive and is based largely on studies in child populations. Methods/Design X-ACT is a three-year, multi-center, placebo controlled, double-blind, randomized clinical trial that tests the effects of daily use of xylitol lozenges versus placebo lozenges on the prevention of adult caries. The trial has randomized 691 participants (ages 21-80) to the two arms. The primary outcome is the increment of cavitated lesions. Discussion This trial should help resolve the overall issue of the effectiveness of xylitol in preventing caries by contributing evidence with a low risk of bias. Just as importantly, the trial will provide much-needed information about the effectiveness of a promising caries prevention agent in adults. An effective xylitol-based caries prevention intervention would represent an easily disseminated method to extend caries prevention to individuals not receiving caries preventive treatment in the dental office. Trial Registration ClinicalTrials.Gov NCT00393055 PMID:20920261
Amaechi Bennett T
Full Text Available Abstract Background Dental caries incidence in adults is similar to that in children and adolescents, but few caries preventive agents have been evaluated for effectiveness in adults populations. In addition, dentists direct fewer preventive services to their adult patients. Xylitol, an over-the-counter sweetener, has shown some potential as a caries preventive agent, but the evidence for its effectiveness is not yet conclusive and is based largely on studies in child populations. Methods/Design X-ACT is a three-year, multi-center, placebo controlled, double-blind, randomized clinical trial that tests the effects of daily use of xylitol lozenges versus placebo lozenges on the prevention of adult caries. The trial has randomized 691 participants (ages 21-80 to the two arms. The primary outcome is the increment of cavitated lesions. Discussion This trial should help resolve the overall issue of the effectiveness of xylitol in preventing caries by contributing evidence with a low risk of bias. Just as importantly, the trial will provide much-needed information about the effectiveness of a promising caries prevention agent in adults. An effective xylitol-based caries prevention intervention would represent an easily disseminated method to extend caries prevention to individuals not receiving caries preventive treatment in the dental office. Trial Registration ClinicalTrials.Gov NCT00393055
Breccia, Massimo; Stagno, Fabio; Luciano, Luigiana; Abruzzese, Elisabetta; Annunziata, Mario; D'Adda, Mariella; Maggi, Alessandro; Sgherza, Nicola; Russo-Rossi, Antonella; Pregno, Patrizia; Castagnetti, Fausto; Iurlo, Alessandra; Latagliata, Roberto; Cedrone, Michele; Di Renzo, Nicola; Sorà, Federica; Rege-Cambrin, Giovanna; La Nasa, Giorgio; Scortechini, Anna Rita; Greco, Giovanna; Franceschini, Luca; Sica, Simona; Bocchia, Monica; Crugnola, Monica; Orlandi, Esther; Guarini, Attilio; Specchia, Giorgina; Rosti, Gianantonio; Saglio, Giuseppe; Alimena, Giuliana
Dasatinib was approved for the treatment of chronic phase (CP) chronic myeloid leukemia (CML) patients in first line therapy based on the demonstration of efficacy and safety reported in patients enrolled in clinical trials. We describe a multicentric Italian "real-life" experience of dasatinib used as frontline treatment outside clinical trials. One hundred and nine patients (median age 54 years) were treated from January 2012 to December 2013. Increased incidence of high risk patients were detected according to stratification (26% according to Sokal score, 19% according to Euro score and 16% according to EUTOS) when compared to company sponsored studies. Median time from diagnosis to start of dasatinib was 18 days. Ten patients received unscheduled starting dose (6 patients 50mg and 4 patients 80 mg QD), whereas 99 patients started with 100mg QD. At 3 months, 92% of patients achieved a BCR-ABL ratio less than 10%. At 6 months, the rate of CCyR was 91% and the rate of MR3 was 40%, with 8% of the patients reaching MR4.5. Ninety-three patients were evaluable at 12 months: the rate of MR3 was 62%, with MR4.5 being achieved by 19% of the patients. At a median follow-up of 12 months, 27 patients (24.7%) were receiving the drug at reduced dose. Two patients (1.8%) experienced a lymphoid blast crisis and the overall incidence of resistance was 8%. As regards safety, the major side effects recorded were thrombocytopenia, neutropenia and pleural effusions, which occurred in 22%, 10% and 8% of patients, respectively. Present results, achieved in a large cohort of patients treated outside clinical trials, further confirm the efficacy and safety of dasatinib as firstline treatment in CML. PMID:26643920
Cano Stefan J
Full Text Available Abstract Background The Anti-Clot Treatment Scale (ACTS is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Its role in clinical trials and other settings should be supported by evidence that it is both clinically meaningful and scientifically sound. The aim of the study was to evaluate the measurement performance of the ACTS (Dutch, Italian, French, German and English language versions in patients with venous thromboembolism based on traditional psychometric methods. Methods ACTS Burdens and Benefits scale data from a large clinical trial (EINSTEIN DVT involving 1336 people with venous thromboembolism were analysed at both the scale and item level. Five key psychometric properties were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (including internal consistency reliability, test-retest reproducibility; validity (including known groups and discriminant validity; and responsiveness. These methods of examination underpin the US Food and Drug Administration recommendations for patient-reported outcome instrument evaluation. Results Overall, the 12-item ACTS Burdens scale and 3-item ACTS Benefits scale met the psychometric criteria evaluated at both item and scale levels, with the exception of some relatively minor issues in the Dutch language version, which were just below reliability criteria (i.e. alpha = 0.72, test-retest intraclass correlation = 0.79. A consistent finding from item-level evaluations of aggregate endorsement frequencies and skewness suggested that response scales may be improved by reducing the number of response options from five to four. Conclusions Both the ACTS Burdens and ACTS Benefits scales consistently satisfied traditional reliability and validity criteria across multiple language datasets, supporting it as a clinically useful patient
Charles, Nathan; Bowman, Howard; Thompson, Simon
It is now almost universally acknowledged that the data language ACT-ONE associated with the formal description technique LOTOS is inappropriate for the purpose of OSI formal description. In response to this the LOTOS restandardisation activity plans to replace ACT-ONE with a functional language. Thus, compatibility between ACT-ONE and the replacement data language becomes an issue. In response to this, we present an experimental investigation of backward compatibility between ACT-ONE and the...
StevenRobertLivingstone; DeannaChoi; FrankARusso
Vocal training through singing and acting lessons is known to modify acoustic parameters of the voice. While the effects of singing training have been well documented, the role of acting experience on the singing voice remains unclear. In two experiments, we used linear mixed models to examine the relationships between the relative amounts of acting and singing experience on the acoustics and perception of the male singing voice. In Experiment 1, twelve male vocalists were recorded while sing...
Hancox Robert J
Full Text Available Abstract Background Regular use of beta-agonists leads to tolerance to their bronchodilator effects. This can be demonstrated by measuring the response to beta-agonist following bronchoconstriction using methacholine. However most studies have demonstrated tolerance after a period of beta-agonist withdrawal, which is not typical of their use in clinical practice. This study assessed tolerance to the bronchodilator action of salbutamol during ongoing treatment with long-acting beta-agonist. Methods Random-order, double-blind, placebo-controlled, crossover trial. After 1 week without beta-agonists, 13 asthmatic subjects inhaled formoterol 12 μg twice daily or matching placebo for 1 week. Eight hours after the first and last doses subjects inhaled methacholine to produce a 20% fall in FEV1. Salbutamol 100, 200 and 400 μg (cumulative dose was then given at 5-minute intervals and FEV1 was measured 5 minutes after each dose. After a 1 week washout subjects crossed over to the other treatment. Unscheduled use of beta-agonists was not allowed during the study. The main outcome variable was the area under the salbutamol response curve. Results The analysis showed a significant time by treatment interaction indicating that the response to salbutamol fell during formoterol therapy compared to placebo. After 1 week of formoterol the area under the salbutamol response curve was 48% (95% confidence interval 28 to 68% lower than placebo. This reduction in response remained significant when the analyses were adjusted for changes in the pre-challenge FEV1 and dose of methacholine given (p = 0.001. Conclusion The bronchodilator response to salbutamol is significantly reduced in patients taking formoterol. Clinically relevant tolerance to rescue beta-agonist treatment is likely to occur in patients treated with long-acting beta-agonists.
Livingstone, Steven R; Choi, Deanna H; Russo, Frank A
Vocal training through singing and acting lessons is known to modify acoustic parameters of the voice. While the effects of singing training have been well documented, the role of acting experience on the singing voice remains unclear. In two experiments, we used linear mixed models to examine the relationships between the relative amounts of acting and singing experience on the acoustics and perception of the male singing voice. In Experiment 1, 12 male vocalists were recorded while singing with five different emotions, each with two intensities. Acoustic measures of pitch accuracy, jitter, and harmonics-to-noise ratio (HNR) were examined. Decreased pitch accuracy and increased jitter, indicative of a lower "voice quality," were associated with more years of acting experience, while increased pitch accuracy was associated with more years of singing lessons. We hypothesized that the acoustic deviations exhibited by more experienced actors was an intentional technique to increase the genuineness or truthfulness of their emotional expressions. In Experiment 2, listeners rated vocalists' emotional genuineness. Vocalists with more years of acting experience were rated as more genuine than vocalists with less acting experience. No relationship was reported for singing training. Increased genuineness was associated with decreased pitch accuracy, increased jitter, and a higher HNR. These effects may represent a shifting of priorities by male vocalists with acting experience to emphasize emotional genuineness over pitch accuracy or voice quality in their singing performances. PMID:24639659
Full Text Available Vocal training through singing and acting lessons is known to modify acoustic parameters of the voice. While the effects of singing training have been well documented, the role of acting experience on the singing voice remains unclear. In two experiments, we used linear mixed models to examine the relationships between the relative amounts of acting and singing experience on the acoustics and perception of the male singing voice. In Experiment 1, twelve male vocalists were recorded while singing with five different emotions, each with two intensities. Acoustic measures of pitch accuracy, jitter, and harmonics-to-noise (HNR ratio were examined. Decreased pitch accuracy and increased jitter, indicative of a lower ‘voice quality’, were associated with more years of acting experience, while increased pitch accuracy was associated with more years of singing lessons. We hypothesized that the acoustic deviations exhibited by more experienced actors was an intentional technique to increase the genuineness or truthfulness of their emotional expressions. In Experiment 2, listeners rated vocalists’ emotional genuineness. Vocalists with more years of acting experience were rated as more genuine than vocalists with less acting experience. No relationship was reported for singing training. Increased genuineness was associated with decreased pitch accuracy, increased jitter, and a higher harmonics-to-noise ratio. These effects may represent a shifting of priorities by male vocalists with acting experience to emphasize emotional genuineness over pitch accuracy or voice quality in their singing performances.
Oncologists have several reasons for trying to maintain or increase hemoglobin levels in their patients during therapy. Relief of the symptoms of anemia, including fatigue and dyspnea, are traditional, well-accepted indications. A newer rationale is to enhance the efficacy of radiation therapy and/or chemotherapy in controlling tumors. A laboratory animal study found that administration of recombinant human erythropoietin (rHuEPO) increased intratumoral median oxygen levels and diminished the proportion of measurements in the very low (<3 mm Hg) range. Hemoglobin level is a strong independent prognostic factor for tumor control by radiation therapy. The hemoglobin level at the end of radiation therapy is a stronger prognostic factor than is the hemoglobin level at the start of therapy. Numerous clinical trials have utilized rHuEPO during radiation with or without concurrent chemotherapy. All 4 trials which enrolled patients with low hemoglobin levels (<12 to 13.5 g/dl) found that rHuEPO significantly increased hemoglobin within 2 weeks and that hemoglobin levels continued to rise until the end of rHuEPO treatment. rHuEPO was efficacious in limiting the decrease in hemoglobin and use of packed red blood cell transfusion in the one reported trial in which it was used in patients with initially normal hemoglobin levels during intensive concurrent radiation and chemotherapy. One trial found a statistically significant improvement in complete pathologic response rate after neoadjuvant chemoradiotherapy with the use of rHuEPO. rHuEPO has a potentially large role to play in the care of the cancer patient. (orig.)
Full Text Available Abstract Background Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services. Methods The example intervention was education to public health nurses (PHN (childbirth classes to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers. The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR. Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence. Results It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial. Conclusion Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health
This paper discusses the use of participant-generated drawings and drama workshops as user experience research methods. In spite of the lack of background literature on how drawings can generate useful insights on HCI issues, drawings have been successfully used in other research fields. On the...... contrary, drama workshops seem to be increasingly popular in recent participatory design research. After briefly introducing such previous work, three case studies are presented, illustrating the use of drawing and drama workshops when investigating the relationship between media technology users and two...... specific devices, namely televisions and mobile phones. The paper focuses on the methods and discusses their benefits and the challenges associated with their application. In particular, the findings are compared to those collected through a quantitative cross-cultural survey. The experience gathered...
Räsänen, Panajiota; Lappalainen, Päivi; Muotka, Joona; Tolvanen, Asko; Lappalainen, Raimo
Stress, anxiety and depression are relatively common problems among university students. This study examined whether an online psychological intervention aiming at enhancing the wellbeing of university students could be an effective and practical alternative for meeting the needs of a university population. University students (N = 68; 85% female; 19-32 years old) were randomly assigned to either a guided seven-week online Acceptance and Commitment Therapy (iACT) intervention or a waiting list control condition (WLC). A between-groups pre-post (iACT vs WLC) design with 12-month follow-up for the iACT participants was conducted. The intervention participants were offered two face-to-face meetings, completed online exercises during a five-week period, and received personal weekly written feedback via the website from their randomly assigned, trained student coaches. Waitlist participants were offered the intervention program soon after the post measurements. Results in this small efficacy trial showed that the iACT participants had significantly higher gains in wellbeing (between group, d = 0.46), life satisfaction (d = 0.65), and mindfulness skills (d = 0.49). In addition, iACT participants' self-reported stress (d = 0.54) and symptoms of depression (d = 0.69) were significantly reduced compared to the participants in the control group. These benefits were maintained over a 12-month follow-up period (within iACT group, d = 0.65-0.69, for primary measures). The results suggest that an online-based, coach-guided ACT program with blended face-to-face and online sessions could be an effective and well-accepted alternative for enhancing the wellbeing of university students. PMID:26848517
A Memorandum of Agreement has been signed by the federal government and the Government of New Brunswick concerning a trial opening of the Petitcodiac River Causeway gates at Riverview, New Brunswick. The structure has significantly impeded upstream and downstream diadromous fish migration. Several renovations have been undertaken to solve the problem. Environment Canada and the Department of Fisheries and Oceans have conducted an environmental assessment to address relevant environmental issues concerning the trial gate opening. This report is the draft of the environmental assessment, providing a description of the scope, time table and methodology of the assessment and a list of the various consultations undertaken during the assessment. The project is expected to begin as early as April 1, 1999, with a pre-trial flushing and the drawdown of the head pond. Once the river flow is low enough to allow the management of the gates, the trial gate will be opened. The project will end with the refilling of the head pond, possibly as late as November 1999. 30 refs., 5 tabs., 1 append
Lavey, R.S. [Radiation Oncology Program, Childrens Hospital Los Angeles, Univ. of Southern California, CA, Los Angeles (United States)
Oncologists have several reasons for trying to maintain or increase hemoglobin levels in their patients during therapy. Relief of the symptoms of anemia, including fatigue and dyspnea, are traditional, well-accepted indications. A newer rationale is to enhance the efficacy of radiation therapy and/or chemotherapy in controlling tumors. A laboratory animal study found that administration of recombinant human erythropoietin (rHuEPO) increased intratumoral median oxygen levels and diminished the proportion of measurements in the very low (<3 mm Hg) range. Hemoglobin level is a strong independent prognostic factor for tumor control by radiation therapy. The hemoglobin level at the end of radiation therapy is a stronger prognostic factor than is the hemoglobin level at the start of therapy. Numerous clinical trials have utilized rHuEPO during radiation with or without concurrent chemotherapy. All 4 trials which enrolled patients with low hemoglobin levels (<12 to 13.5 g/dl) found that rHuEPO significantly increased hemoglobin within 2 weeks and that hemoglobin levels continued to rise until the end of rHuEPO treatment. rHuEPO was efficacious in limiting the decrease in hemoglobin and use of packed red blood cell transfusion in the one reported trial in which it was used in patients with initially normal hemoglobin levels during intensive concurrent radiation and chemotherapy. One trial found a statistically significant improvement in complete pathologic response rate after neoadjuvant chemoradiotherapy with the use of rHuEPO. rHuEPO has a potentially large role to play in the care of the cancer patient. (orig.) [Deutsch] In der Onkologie bestehen zahlreiche Gruende, die Haemoglobinkonzentration der Patienten waehrend der Therapie zu halten oder sogar anzuheben. Als anerkannte Indikation gilt hierbei die Besserung anaemiebedingter Symptome wie Muedigkeit und Dyspnoe, wobei jedoch neuere Ergebnisse darauf hinweisen, dass auch die Effizienz der Strahlen- und
John J. Pilch
Full Text Available Luke reports more than twenty altered states of consciousness experiences in Acts of the Apostles. These are common and normal human experiences in approximately ninety percent of contemporary cultures. In the ancient Circum-Mediterranean world, it seems to have been common and normal in about eighty percent of those cultures. Insights from psychological anthropology, cultural anthropology and cognitive neuroscience contribute to an improved understanding and interpretation of these experiences in the Bible, particularly the call of Paul as reported in Acts 9; 22; 26.
The Danish Act on Processing of Personal Data applies to all processing of data for the purpose of carrying out medical trials and other scientific or statistical studies. Prior to the commencement of the processing of data, a private controller, i.e. a pharmaceutical company, shall notify the Danish Data Protection Agency and obtain the authorisation of the Agency. The article presents the various conditions laid down by the Agency for the carrying out of the processing operations. Furthermore, special attention is drawn to the data subject's various rights. In order to ensure the privacy of the data subject and to protect data against accidental or unlawful destruction, loss or alteration and against unauthorized disclosure, the controller shall implement certain technical and organisational security measures laid down by the Agency. When a controller leaves the processing of data to a processor, the processor is obliged to ensure compliance with the given measures. The Data Protection Agency supervises that the processing is carried out in compliance with the provisions of the Act and the conditions laid down by the Agency. PMID:12756831
Estabrook, Polly; Dessouky, Khaled; Jedrey, Thomas
To explore the potential of Ka-band to support mobile satellite services, the Jet Propulsion Laboratory (JPL) has initiated the design and development of a Ka-band land-mobile terminal to be used with the Advanced Communications Technology Satellite (ACTS). The planned experimental setup with ACTS is described. Brief functional descriptions of the mobile and fixed terminals are provided. The inputs required from the propagation community to support the design activities and the planned experiments are also discussed.
McBain, Bonnie; Drew, Antony; James, Carole; Phelan, Liam; Harris, Keith M; Archer, Jennifer
Purpose: The purpose of this paper is to evaluate the experiences of tertiary students learning oral presentation skills in a range of online and blended learning contexts across diverse disciplines. Design/methodology/approach: The research was designed as a "federation" of trials of diverse online oral communications assessment tasks…
Meltzer, H Y; Lindenmayer, J-P; Kwentus, J; Share, D B; Johnson, R; Jayathilake, K
It has been suggested that atypical antipsychotic drugs (A-APDs) other than clozapine may be effective to improve positive symptoms in some patients with treatment resistant schizophrenia (TRS), if both the dose is higher, and the duration of the trial longer, than those which have been ineffective in non-TRS (NTRS) patients. This hypothesis was tested with long acting injectable risperidone (Risperdal Consta®, RLAI). One hundred sixty TRS patients selected for persistent moderate-severe delusions or hallucinations, or both, were randomized to RLAI, 50 or 100mg biweekly, in a six month, outpatient, double-blind, multicenter trial. We hypothesized that RLAI, 100mg, would be more effective than RLAI, 50mg. However, both doses produced clinically significant and equivalent improvement in PANSS Total, Positive, and Negative subscale scores, as well as key cognitive, global and functional measures, with increasing response during the course of the study, confirming the value of longer clinical trial duration for patients with TRS, but not superiority of the higher dose. The overall response rate was comparable to that previously reported for clozapine and high dose olanzapine, another A-APD, in TRS. Both doses of RLAI were equally well tolerated, producing minimal extrapyramidal side effects and few drop outs. Plasma levels of the active moiety, risperidone+9-hydroxyrisperidone, during treatment with RLAI 100mg, were comparable to those for 6-8 mg/day oral risperidone, which have not been effective in TRS. Further study of RLAI, ≥ 50-100mg biweekly, should compare it with clozapine and oral risperidone in TRS, with duration of treatment ≥ six months. PMID:24630262
The Monju trial means the judgment Nagoya High Court Kanazawa branch office made on January 27, 2003 to invalidate the Monju construction permission because there are 'a blunder, the omission that are hard to overlook' for safety examination, and also wrong serious enough to invalidate the permission. Forty-three opinions of people of learning and experience were presented on this special number. Most of them expressed the judgment was technically irrational. Technical points regarding the trial decision were disputed. Some appreciated the judgment based on precautionary principle. (T. Tanaka)
An experiment was carried out in which a field treatment of a small bulk of grain with chlorpyrifos-methyl was compared with a laboratory treatment of 1 kg of grain with 14C radiolabelled chlorpyrifos-methyl. The conditions under which the grain was maintained in the laboratory mimicked those of the field trial as closely as possible, with sampling and analysis being carried out at the same time and in a similar manner in both. The results from the two experiments were in general agreement with approx. 60% of the chlorpyrifos-methyl remaining intact at the end. A satisfactory level of biological control was achieved in the field trial. The use of the radio-label enabled more information about the fate of the degraded insecticide to be obtained from the laboratory experiment. The majority of this radioactivity comprised a fraction which remained within the grain tissue after solvent extraction. The level of activity in the grain tissues gradually increased with time but its nature is as yet unknown. The good agreement obtained between the residue profile and the breakdown patterns in both experiments would suggest that a laboratory scale experiment is a satisfactory model for the situation pertaining in a large scale field trial. (author)
Thornquist, Mark D; Edelstein, Cim; Goodman, Gary E; Omenn, Gilbert S
With their extensive data and specimen repositories, clinical trials are a long-term, valuable resource to health researchers. However, assuring protection of participants' rights can be challenging, particularly when such trials are conducted at multiple sites with multiple Institutional Review Boards (IRBs). One little-used mechanism that can streamline IRB review in multisite trials while maintaining participants' protections is the single-study IRB Cooperative Agreement. This agreement is entirely different from reciprocity agreements between institutions. Beginning in 1996, the Beta-Carotene and Retinol Efficacy Trial established single-study IRB Cooperative Agreements among its performance sites, which reduced the average time to complete IRB approval from over 6 months to 1 month for each of many substudies. We describe our experience and make recommendations for other multisite clinical trials. PMID:11852169
Full Text Available Randomised controlled clinical trials are fundamental in medicine to develop new effective drugs and new therapeutic regimens and are the strength of evidence-based medicine. These studies allow us to avoid the repetition of misleading experiences that have been reported in the past, where drugs or associations were utilised without compelling evidence and ultimately proven to be ineffective. In recent years, randomised clinical trials have been conducted and concluded for many rare diseases, including idiopathic pulmonary fibrosis. However, clinical trials do not always reflect the real-life scenario. Patients selected for clinical trials present fewer comorbidities, they fall between certain age limits, and the severity of their disease is defined; therefore, they do not always reflect the whole of the population affected by a specific disease. These are the reasons why we also need data that mirror real-life experience. The limitations that these kind of studies present are always several and the studies should be interpreted with caution, although they can fill the important gap between efficacy and effectiveness. In this article, we will review the existing clinical data on real-life treatment of idiopathic pulmonary fibrosis.
Cathleen S. Graham
Full Text Available The Adoption and Safe Families Act of 1997 (ASFA is expected to have a profound impact on children and families the child welfare system serves. This article provides information about Indiana’s experience in implementing ASFA, including policy decisions made by the legislative and executive branches of government and the involvement of the judiciary. A multidisciplinary task force addressed training and program needs for positive implementation. Initial outcomes for Indiana children and remaining challenges are discussed.
Chaoying Tang; Craig R. Seal; Stefanie E. Naumann; Krystal Miguel
Prior research has demonstrated the impact of employee emotional labor strategies (deep and surface acting) on customer behavioral intentions. However, there is limited data on the impact of emotional labor strategy on potential intervening variables and on actual buying decisions. This study extends the prior research by examining the effect of employee emotional labor strategies on customers’ emotional experiences and actual customer purchasing decisions. Data were collected from 294 employ...
Full Text Available Prior research has demonstrated the impact of employee emotional labor strategies (deep and surface acting on customer behavioral intentions. However, there is limited data on the impact of emotional labor strategy on potential intervening variables and on actual buying decisions. This study extends the prior research by examining the effect of employee emotional labor strategies on customers’ emotional experiences and actual customer purchasing decisions. Data were collected from 294 employee-customer pairs from retail cell phone stores in China. Results indicated that choice of strategy (deep or surface does significantly impact purchase decisions. In addition, the relationship between strategy and purchase is mediated by the customer's emotional experience.
Duhamet, Jean; Lanoe, Jean-Yves; Rivalier, Patrick; Borda, Gilles [Commissariat a l' Energie Atomique (CEA), CEA/DEN/VRH/DTEC/SGCS, Centre de Marcoule - BP 17171, 302007 Bagnols-sur-Ceze cedex (France)
Many trials have been performed in ATALANTE's shielded cells to demonstrate the technical feasibility of processes involving minor actinide separation. They required developments of new extractors as well as a step by step procedure have been used to lower the risks of malfunction during high active operation. The design of the extractors developed by Cea has included shielded cells restrictions, miniaturization to lower the quantity of high active material and wastes and the care for being representative of industrial equipment. After individual shake down inactive tests, with actual phases, each process experiment scheduled in ATALANTE has been tested at G1 Facility in Marcoule. The objective was to reproduce as much as possible all the equipment chosen for active tests. This procedure has demonstrated its efficiency to detect many problems that would have heavy impact if they have been discovered during active trials. It was also used for operators'training. (authors)
Di Valentino, Eleonora; Lattanzi, Massimiliano; Melchiorri, Alessandro; Natoli, Paolo; Pagano, Luca; Said, Najla
The Atacama Cosmology Telescope (ACT) and the South Pole Telescope (SPT) have recently provided new, very precise measurements of the cosmic microwave background (CMB) anisotropy damping tail. The values of the cosmological parameters inferred from these measurements, while broadly consistent with the expectations of the standard cosmological model, are providing interesting possible indications for new physics that are definitely worth of investigation. The ACT results, while compatible with the standard expectation of three neutrino families, indicate a level of CMB lensing, parametrized by the lensing amplitude parameter A_L, that is about 70% higher than expected. If not a systematic, this anomalous lensing amplitude could be produced by modifications of general relativity or coupled dark energy. Vice-versa, the SPT experiment, while compatible with a standard level of CMB lensing, prefers an excess of dark radiation, parametrized by the effective number of relativistic degrees of freedom N_eff. Here we p...
Shoushtari, Alexander N; Ong, Leonard T; Schoder, Heiko; Singh-Kandah, Shahnaz; Abbate, Kelly T; Postow, Michael A; Callahan, Margaret K; Wolchok, Jedd; Chapman, Paul B; Panageas, Katherine S; Schwartz, Gary K; Carvajal, Richard D
The aim of this study was to test the hypothesis that inhibiting mammalian target of rapamycin and insulin-like growth factor-1 receptor would be efficacious in metastatic uveal melanoma. This was a phase 2 trial of everolimus 10 mg daily plus pasireotide long-acting release 60 mg every 28 days enrolling patients with progressive, metastatic uveal melanoma to treatment until progression by Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) or unacceptable toxicity. The primary endpoint was clinical benefit rate, defined as any objective response or RECIST 1.1 stable disease at 16 weeks. A subset of patients underwent baseline indium-111-octreotide scans. A total of 14 patients were enrolled, of which 13 were evaluable for the primary endpoint, before the study was terminated due to poor accrual. Three of 13 (26%) patients obtained clinical benefit. Seven of 13 (54%) had stable disease lasting for a median of 8 weeks (range: 8-16 weeks). Grade 3 adverse events deemed at least possibly related to study drugs were hyperglycemia (n=7), oral mucositis (n=2), diarrhea (n=1), hypophosphatemia (n=1), and anemia (n=1). Seven of 14 (50%) patients required at least one dose reduction due to toxicity. Seven of eight (88%) patients with baseline indium-111-octreotide scans had at least one avid lesion, with significant intrapatient heterogeneity. There was a trend toward an association between octreotide avidity and cytostatic response to therapy (P=0.078). The combination of everolimus and pasireotide has limited clinical benefit in this small metastatic uveal melanoma cohort. Dose reductions for side effects were common. Further investigation into the relationship between somatostatin receptor expression and cytostatic activity of somatostatin analogues is warranted. PMID:26795274
Ren, Zhaoxia; Zajicek, Anne
Children have been called therapeutic orphans as they have been excluded from drug research and new drug development resulting in the lack of proper labels for majority of the drugs for pediatric use. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are two legislative mandates to improve pediatric drug labeling. The BPCA legislation authorizes the National Institutes of Health (NIH) to implement research programs through funding clinical trials to study off-patent drugs in pediatric population. Obstetric pharmacology research gaps are in many ways similar to those in pediatrics, including off-label use of common medications, and lack of knowledge of appropriate dosing, safety, and efficacy of drugs. Much research is needed to define mechanisms of disease and drug actions in pregnant women to fill the knowledge gaps. PMID:26455383
Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may
The Japan Nuclear Cycle Development Institute (JNC) and Los Alamos National Laboratory (LANL) have developed a Remote Monitoring System (RMS) for unattended mode Nondestructive Assay (NDA) at the Plutonium Fuel Production Facility (PFPF). The principal objective of this development is to improve the efficiency of safeguards activities for both the operator and the inspectorates, and to improve transparency of nuclear material management. In June 1999, with the cooperation of the IAEA and JSGO, the RMS was installed for field trial at the plutonium storage area in PFPF. At the beginning of the field trial, the RMS encountered reliability problems in both hardware and software. At this point, these difficulties have been mostly overcome by steady, progressive improvements in hardware and by upgrading of software and troubleshooting procedures. The RMS has successfully taken data for more than 13 consecutive months from the May 2001. Reliable remote transmission of NDA data has been demonstrated under realistic operational conditions. This paper describes the outline and status of the PFPF RMS based on the experience gained in the field trial. Future plans for implementing remote monitoring under the international safeguards regime are also discussed. (author)
Sodium used as a coolant in the SFR is utilized in various fields and yet there has been no record of handling and storing sodium exceeding designated quantity, which is a quantity that serves as the lowest level permitted for construction. The difficulty in achieving the license for sodium experiment facilities and equipment has been the main issue since the first time of sodium-related plan. Sodium is under regulation of four kinds of laws including the Safety Control of Dangerous Substances Act and it is under categorized as Class 3(pyrophoric material and water-prohibiting substance). The objective of this study is to investigate the procedure of installing a sodium-related facility and achieving the license from the fire agency of government. In this work, the licensing procedure for a sodium experiment facility was investigated under the Safety Control of Dangerous Substances Act. For the construction of the PGSFR (Prototype Gen-IV Sodium cooled Fast Reactor), the described procedure should be reviewed and prepared carefully in accordance with the fire safety regulatory body
Described are the details of trial in-pile sodium loop for the NSRR experiment and its performance test results. The loop can be inserted inside the experimental tube of the NSRR reactor, and consists of main four systems of sodium circulation, cover gas, evacuation and air cooling. Seven fuel pins in maximum can be accommodated in the test section, and the test section is surrounded by neutron modetator made of zirconium hydride to get higher thermal neutron flux, thereby higher energy deposition in a test fuel pin. The loop is a doubly contained loop to avoid sodium leakage to the experimental tube in case of the failure of the sodium circulation systems, and thermal insulation is made by evacuating the gas inside the secondary containment. The performance test was made successfully, and the design target values of sodium temperature of 5000C and sodium velocity of 8 m/sec were attained well stably and safely through the test, although the operation with high sodium velocity at low sodium temperature was rather difficult due to large heat generation by the operation of the electromagnetic pump. Furthermore, before filling the loop with sodium, trial cutting and welding at the test section were performed for exchange it after the in-pile experiment and the difficulties and problems of the work were understood. (author)
Full Text Available Abstract Background The long acting β2-agonists, salmeterol and formoterol, have been recommended, by some, as first line treatment of stable chronic obstructive pulmonary disease (COPD. We reviewed evidence of efficacy and safety when compared with placebo or anticholinergic agents in patients with poorly reversible COPD. Methods After searching MEDLINE, EMBASE, HealthSTAR, BIOSIS Previews, PASCAL, ToxFile, SciSearch, the Cochrane Library, and PubMed, as well as Web sites, selected journals, reference lists, and contacting drug manufacturers, two reviewers independently screened reports of randomised controlled trials of parallel or crossover design lasting four weeks or longer and including patients with a forced expiratory volume in one second (FEV1 ≤ 75% of predicted, a ratio of FEV1 to forced vital capacity (FVC ≤ 88% of predicted, and Results Twelve trials satisfied our inclusion criteria; eight were high quality (Jadad score >2 and four were low quality (≤ 2. The adequacy of allocation concealment was unclear in all of them. We did not perform a meta-analysis due to differences in trial design and how outcomes were reported. Two trials comparing salmeterol with ipratropium did not detect differences; one trial comparing formoterol and ipratropium described greater improvement with formoterol in morning PEFR (15.3 versus 7.1 l/min, p = 0.040. Of twelve trials comparing long acting β2 agonists with placebo, six reported no improvement in exercise capacity, eleven reported improvements in FEV1 lung function (one reported no improvement, six reported less rescue inhaler usage (one reported no difference and five reported improved dyspnea scores (two reported no improvement. Differences in quality of life were detected in one salmeterol trial ; however, two salmeterol, and one formoterol trial reported no differences. Adverse effects of interest were not reported. Conclusion In terms of clinical outcomes and safety, we could not find
Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy
Full Text Available Abstract Background Aceltylcysteine has been evaluated in several small trials as a means of reducing the risk of contrast-induced nephropathy (CIN, however systematic reviews of these studies do not provide conclusive answers. Therefore, a large randomized controlled trial (RCT is needed to provide a reliable answer as to whether acetylcysteine is effective in decreasing the risk of CIN in high-risk patients undergoing angiographic procedures. Methods ACT is a RCT of acetylcysteine versus placebo in 2,300 patients at-risk for CIN undergoing an intravascular angiographic procedure. The randomization list will be concealed. Participants, health care staff, investigators and outcome assessors will be blinded to whether patients receive acetylcysteine or placebo. All analysis will follow the intention-to-treat principle. The study drugs (acetylcysteine 1200 mg or placebo will be administered orally twice daily for two doses before and two doses after the procedure. The primary outcome is the occurrence of CIN, defined as a 25% elevation of serum creatinine above baseline between 48 and 96 hours after angiography. Discussion The first patient entered the trial on September, 2008. Up to April 7, 2009, 810 patients had been included in 35 centers. The mean age was 69 (Standard deviation: 10, 18% had a baseline serum creatinine >1.5 mg/dL, 57% were diabetics and 13% had a history of heart failure. The ongoing ACT Trial is the largest multicentre RCT that will determine whether acetylcysteine is effective in decreasing the risk of CIN in patients at risk undergoing angiography. Trial registration Clinicaltrials.gov NCT00736866
Kwakye, Isaac N.; Garner, Matthew; Baldwin, David S.; Bamford, Susan; Pinkney, Verity
Objective The objective of this study was to develop an in‐depth understanding of healthy volunteers' experiences of mental health trials. Methods A qualitative study was nested within a healthy volunteer placebo‐controlled trial of duloxetine, a psychotropic drug used for treating patients with major depression and generalized anxiety disorder. Eight participants were interviewed, and data were analyzed using interpretative phenomenological analysis. Results Interviewees described volunteering for the trial because they were interested in research, wanted the monetary incentive, wanted to help researchers, and wanted to be part of something. On entering the trial, participants considered the possible risks and described feeling anxious, excited, and determined; they had some clear expectations and some loosely held hopes about what would happen. During the trial, participants were curious about whether they were taking duloxetine or placebo, self‐monitored their bodies' reactions, and guessed which treatment they received. On being un‐blinded to treatment allocation after completing the trial, some participants' guesses were confirmed, but others were surprised, and a few were disappointed. Conclusions Small changes to advertising/consent materials to reflect volunteers' motivations could improve recruitment rates to similar trials; “active” placebos might be particularly useful for maintaining blinding in healthy volunteer trials; and sensitive procedures are needed for un‐blinding participants to treatment allocation. © 2016 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons, Ltd. PMID:27378326
Lage-Castellanos, Agustin; Nieto, Juan I; Quiñones, Ileana; Martinez-Montes, Eduardo
This paper proposes a machine learning based approach to discriminate between EEG single trials of two experimental conditions in a face recognition experiment. The algorithm works using a single-trial EEG database of multiple subjects and thus does not require subject-specific training data. This approach supports the idea that zero-training classification and on-line detection Brain Computer Interface (BCI) systems are areas with a significant amount of potential. PMID:21096895
Bruce H. K. Dobkin, MD
Full Text Available The Locomotor Experience Applied Post Stroke rehabilitation trial found equivalent walking outcomes for body weight-supported treadmill plus overground walking practice versus home-based exercise that did not emphasize walking. From this large database, we examined several clinically important questions that provide insights into recovery of walking that may affect future trial designs. Using logistic regression analyses, we examined predictors of response based on a variety of walking speed-related outcomes and measures that captured disability, physical impairment, and quality of life. The most robust predictor was being closer at baseline to the primary outcome measure, which was the functional walking speed thresholds of 0.4 m/s (household walking and 0.8 m/s (community walking. Regardless of baseline walking speed, a younger age and higher Berg Balance Scale score were relative predictors of responding, whether operationally defined by transitioning beyond each speed boundary or by a continuous change or a greater than median increase in walking speed. Of note, the cutoff values of 0.4 and 0.8 m/s had no particular significance compared with other walking speed changes despite their general use as descriptors of functional levels of walking. No evidence was found for any difference in predictors based on treatment group.
Chen, Wen-Yin; Lin, Shih-Ku
We conducted a cross-sectional study to compare the subjective experiences and clinical effects of first-generation long-acting injectable (FGA-LAI) antipsychotics with those of risperidone long-acting injectables (RIS-LAIs) in 434 schizophrenia patients. Compared with the RIS-LAI group, the patients treated with FGA-LAIs had a significantly longer duration of illness and LAI treatment and were older. Our results suggest that patients treated with FGA-LAI have more satisfactory subjective experiences compared with patients treated with RIS-LAI and that both FGA-LAI and RIS-LAI treatments can prevent relapses and hospitalization. Additional longitudinal studies determining the long-term benefits of RIS-LAI are warranted. PMID:27580495
Mette Lundgaard; Louise Raboel; Elisabeth Broegger Jensen; Jacob Anhoej; Beth Lilja Pedersen; Danish Society for Patient Safety
This paper describes the process that lead to the passing of the Act for Patient Safety in the Danish health care system, the contents of the act and how the act is used in the Danish health care system.
The act obligates frontline health care personnel to report adverse events, hospital owners to act on the reports and the National Board of Health to communicate the learning nationally.
The act protects health care providers from sanctions as a re...
Lundgaard, Mette; Rabøl, Louise; Jensen, Elisabeth Agnete Brøgger;
This paper describes the process that lead to the passing of the Act for Patient Safety in the Danisk health care sytem, the contents of the act and how the act is used in the Danish health care system. The act obligates frontline health care personnel to report adverse events, hospital owners to...... act on the reports and the National Board of Health to commuicate the learning nationally. The act protects health care providers from sanctions as a result of reporting. In January 2004, the Act on Patient Safety in the Danish health care system was put into force. In the first twelve months 5740...... adverse events were reported. the reports were analyzed locally (hospital and region), anonymized ad then sent to the National Board af Health. The Act on Patient Safety has driven the work with patient safety forward but there is room for improvement. Continuous and improved feedback from all parts of...
Aim: Contemporary radiotherapy clinical trials typically require complex three-dimensional (3D) treatment planning. This produces large amounts of data relating technique and dose delivery for correlation with patient outcomes. Assessment of the quality of this information is required to ensure protocol compliance, to quantify the variation in treatments given to patients and to enhance the power of studies to determine correlates of patient outcomes. Materials and methods: A software system ('SWAN') was developed to facilitate the objective analysis, quality-assurance and review of digital treatment planning data from multi-centre radiotherapy trials. The utility of this system was assessed on the basis of its functionality and our experience of its use in the context of multi-centre clinical trials and trials-support activities. Results: The SWAN system has been shown to have the functionality required for use in several multi-centre trials, including automated review and archive processes. Approximately 800 treatment plans from over 30 participating institutions have so far been assessed with the system for several treatment planning scenarios. To illustrate this we include a description of the use of the system for a large-recruitment prostate radiotherapy trial being undertaken in Australasia, including examples of how the review process has changed clinical practice. Conclusion: The successful implementation of SWAN has been demonstrated in a number of clinical trials. The software provides an opportunity for comprehensive review of treatment parameters that could impact on clinical outcomes and trial results. Such quality-assurance (QA) has previously been difficult or impossible to achieve, particularly for a clinical trial involving large numbers of patients. Such reviews have highlighted inconsistencies in clinical practice that have since been addressed through feedback from the review process. The process of data collection and review should be
This short historical review attempts to shed light on the tortuous road on which society moved toward the general acceptance of the idea of experimenting on human beings. Unfortunately people had to realize that under antihuman or lenient political leadership, some physicians might apply their knowledge against their fellow beings, or might endanger them while pursuing their scientific goals. For this reason, it became necessary to codify the ethical requirements of medical experiments. This was done first by the Prussian government in 1900. The historical significance of the Nuremberg physicians' trials is that, by recognizing the enormous scientific importance of human experiments, they led to the formulation of general ethical principles governing human studies, which became known as the Nuremberg Code. Broad, international regulations were developed as the consequence of the trial. Unfortunately human experiments performed on prison inmates were judged at the trial as ethically acceptable, provided an informed consent was signed. Misusing this possibility many unethical experiments were done primarily in the US after the war. The great indignation due to ethical misconduct in prison trials and the highly unethical Tuskegee experiments performed on black Americans' suffering from syphilis, led much later to the organization of independent ethics committees. Through these committees, society exercises supervision of human trials. However, in case of severely ill patients the physician might be left alone to make a quick, and ethically correct, decision corresponding to the situation. In the final analysis the safety and ethical protection of research subjects remain the joint responsibility of society and of the experimenting physicians. PMID:18218586
As part of the Norwegian Clean Seas Association For Operating Companies' (NOFO) ''oil on water''-exercise early June 1994, a dispersant field trial was carried out. During the experiment period, an extensive monitoring programme was carried out. both on surface oil/emulsion, dispersed oil (subsurface monitoring) as well as monitoring by aerial remote sensing. The aerial remote sensing included SLAR (Side-Looking Airborne Radar) and IR/UV from the surveillance aircrafts from the Norwegian State Pollution Control Authority (SPCA) and the Swedish Coast Guard. In addition to the planned monitoring programme, the spill was detected in an ERS-1 SAR scene by the Operational oil spill detection service run by Tromsoe Satellite Station (TSS) and the Norwegian Defence Research Establishment (NDRE). The remotely sensed data from the Swedish Coast Guard are stored digitally on computer tape, and after the experiment, selected IR/UV data have been processed and analyzed to estimate the areal distribution of thick oil (emulsion) and thinner oil (''rainbow'', ''blueshine'') and how this distribution changed with time. This paper presents how the data was processed, associated problems, and the results of the analysis. The paper also includes information about the oil spill and surrounding wave conditions as derived from the ERS-1 SAR scene. 3 refs., 7 figs., 4 tabs
Tinelli Michela; Ozolins Mara; Bath-Hextall Fiona; Williams Hywel C
Abstract Background The SINS trial (Controlled Clinical Trials ISRCTN48755084; Eudract No. 2004-004506-24) is a randomised controlled trial evaluating long term success of excisional surgery vs. imiquimod 5% cream for low risk nodular and superficial basal cell carcinoma (BCC). The trial included a discrete choice experiment questionnaire to explore patient preferences of a cream versus surgery for the treatment of their skin cancer. Methods The self-completed questionnaire was administered a...
Reddy, Venkat; Jayne, David; Close, David; Isenberg, David
B cells are believed to be central to the disease process in systemic lupus erythematosus (SLE), making them a target for new therapeutic intervention. In recent years there have been many publications regarding the experience in SLE of B-cell depletion utilising rituximab, an anti-CD20 mAb that temporarily depletes B cells,reporting promising results in uncontrolled open studies and in routine clinical use. However, the two large randomised controlled trials in extra-renal lupus (EXPLORER study) and lupus nephritis (LUNAR study) failed to achieve their primary endpoints. Based on the clinical experience with rituximab this failure was somewhat unexpected and raised a number of questions and concerns, not only into the true level of benefit of B-cell depletion in a broad population but also how to test the true level of effectiveness of an investigational agent as we seek to improve the design of therapeutic trials in SLE. A better understanding of what went wrong in these trials is essential to elucidate the underlying reasons for the disparate observations noted in open studies and controlled trials. In this review, we focus on various factors that may affect the ability to accurately and confidently establish the level of treatment effect of the investigational agent, in this case rituximab, in the tw studies and explore hurdles faced in the randomised controlled trials investigating the efficacy of ocrelizumab, the humanised anti-CD20 mAb, in SLE. Further, based on the lessons learned from the clinical trials, we make suggestions that could be implemented in future clinical trial design to overcome the hurdles faced. PMID:23566295
Amass, Leslie; Ling, Walter; Freese, Thomas E.; Reiber, Chris; Annon, Jeffrey J.; Cohen, Allan J.; M.F.T.; McCarty, Dennis; Reid, Malcolm S.; Brown, Lawrence S.; Clark, Cynthia; Ziedonis, Douglas M.; Krejci, Jonathan; Stine, Susan; Winhusen, Theresa
In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone®) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opi...
Smed, Marie; Schultz, Carsten; Getz, Kenneth A.;
The collaboration with medical professionals in pharmaceutical clinical trials facilitates opportunities to gain valuable market information concerning product functionality issues, as well as issues related to market implementation and adoption. However, previous research on trial management lacks...... a differentiated perspective on the potential for information transfer from site to producer. An exploration of the variation in stickiness of information, and therefore the complexity of information transfer in clinical trials, is the main aim of this study. To further enrich the model of the dispersed sites......, complementary service issues and usability patterns are all significantly more difficult to transfer in clinical trials than issues related to product functionality....
Arch, Joanna J.; Eifert, Georg H.; Davies, Carolyn; Vilardaga, Jennifer C. Plumb; Rose, Raphael D.; Craske, Michelle G.
Objective: Randomized comparisons of acceptance-based treatments with traditional cognitive behavioral therapy (CBT) for anxiety disorders are lacking. To address this gap, we compared acceptance and commitment therapy (ACT) to CBT for heterogeneous anxiety disorders. Method: One hundred twenty-eight individuals (52% female, mean age = 38, 33%…
Hall, Barry; Breslin, Niall; McNamara, Deirdre
Introduction Small bowel angiodysplasias account for over 50% of causes of small bowel bleeding and carry a worse prognosis than lesions located elsewhere in the gastrointestinal tract. Re-bleeding rates are high even after first-line endoscopic therapy and are associated with high levels of morbidity for affected patients. Small trials of long-acting somatostatin analogues have shown promising results but have not yet been assessed in patients with refractory small bowel disease. Aim The purpose of this study was to assess the effect of long-acting somatostatin analogues in reducing re-bleeding rates and transfusion requirements, and improving haemoglobin levels in patients with refractory small bowel angiodysplasia. Methods Patients with refractory small bowel angiodysplasia were treated with 20 mg of long-acting octreotide for a minimum of three months. Response was assessed according to: rates of re-bleeding, haemoglobin levels, transfusion requirements, and side effects. Results A total of 24 patients were initially treated and 20 received at least three doses. Rates of complete, partial and non-response were 70%, 20% and 10% respectively. Average haemoglobin rates increased from 9.19 g/dl to 11.35 g/dl (p = 0.0027, 95% confidence interval (CI) −3.5 to −1.1) in the group overall and 70% remained transfusion-free after a mean treatment duration of 8.8 months. The rate of adverse events was higher than previously reported at 30%. Conclusion Long-acting somatostatin analogues offer a therapeutic advantage in a significant proportion of patients with small bowel angiodysplasia. With careful patient selection and close observation, a long-acting somatostatin analogue should be considered in all patients with persistent anaemia attributable to refractory disease in conjunction with other standard treatments. PMID:26966525
Kirwan, Bridget-Anne; Lubsen, Jacobus; de Brouwer, Sophie; Danchin, Nicolas; Battler, Alexander; de Luna, Antonio Bayes; Dunselman, Peter H. J. M.; Glasser, Stephen; Koudstaal, Peter J.; Sutton, George; van Dalen, Frederik J.; Poole-Wilson, Philip A.
Objective: Few trials report event-adjudication procedures in detail. Using data from the ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) study, we compared the impact on event-rates of an adjudication strategy based on systematic screening of all reported serious advers
Haverkamp, Beth; Schamel, Wynell
Describes the historical background to the Nuremberg War Trials. Asserts that there is a wealth of evidence in the National Archives documenting atrocities committed by the Nazis. Presents primary source documents used in the Trials and provides seven suggested teaching strategies. (CFR)
Mngadi, Kathryn Therese; Frohlich, Janet; Montague, Carl; Singh, Jerome; Nkomonde, Nelisiwe; Mvandaba, Nomzamo; Ntombeka, Fanelesibonge; Luthuli, Londiwe; Abdool Karim, Quarraisha; Mansoor, Leila
Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention intervention, tried to balance the real-life scenario of no reimbursement for attendance at public sector clinics with that of a trial including some visits that focused on research procedures and others that focused on standard of care procedures. A reduced reimbursement was offered for 'standard of care' visits, meant primarily to cover transport costs to and from the clinic only. This impacted negatively on accrual, retention and participant morale, primarily due to the protracted delay in regulatory approval, during which time, the costs of living, including travel costs had increased. Relevant guidelines were reviewed and institutional policy was updated to incorporate the South African National Health Research Ethics Committee guidelines on reimbursement (taking into account participant time, travel and inconvenience). The reimbursement amount for 'standard of care' visits was increased accordingly. The question remains whether a trial that combines post-trial access with implementation science, with clear benefits for the participants and the provision of above standard medical care, should have reimbursement rates that approach those of a proof-of-concept trial, for 'standard of care' visits. PMID:26392172
Shepelak, Norma J.
Recounts a criminology class exercise that consisted of staging a mock trial using the murders from Truman Capote's "In Cold Blood" as source material. Students research the case and role play various lawyers, jury members, and witnesses. Identifies and discusses four educational objectives attainable through the staging of mock trials. (MJP)
In this paper authors describe the experience gained during commissioning and trial operation of Mochovce NPP (EMO). The first year of EMO operation from the point of view of safety and reliability was successful. Evidently we were challenged with certain problems characteristic to this stage of operation which resulted in automatic reactor shutdown. There were 11 automatic shutdowns in 1998 by action of the quick emergency protection AO-1 and two manual shutdowns by the AO-1 key. In 1999, there were 6 automatic shutdowns by action of the quick emergency protection AO-1. Three of them was connected to the falsely activated binary signal of MCP switch of, in two cases the reason came out from the turbo-generator (TG) cooling water system. Very positive trend in the operation of both units shows the fact that during all commissioning period of the second unit there were only three automatic reactor shutdowns by the signal AO-1. All these actions were done in frame of commissioning tests. All causes which activated the automatic unit shutdowns were found out and rectified, the overall tuning of the cooling water system is on the process now. The solution of this problem is possible only power commissioning, and in the stage of the trial operation had no direct impacts on the nuclear, radiation, or technical safety respectively. In 1998 two events according to the INES scale after second unit commissioning because of two unit links of the cooling water system. The operational events during the commissioning tests, start-up tests, physical commissioning, were ranked the category 1 ('Action of SIS U040 ppo <8,34 MPa at the system 2 and 3' and 'Breaching the L and C'). In 1999 only events occurred that were ranked in the category safety insignificant events and lower (category 0, or off the scale respectively). In the frame of the safety culture principles adopted, such as critical attitude, exact and careful approach, and communication, these problems were given the
Kongsted, Alice; Montvilas, Erisela Qerama; Kasch, Helge;
listed at 1 year follow-up. No significant differences were observed between the 3 interventions group. Conclusion. Immobilization, "act-as-usual," and mobilization had similar effects regarding prevention of pain, disability, and work capability 1 year after a whiplash injury....... practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12...... months postinjury. Treatment effect was measured in terms of headache and neck pain intensity (0-10), disability, and work capability. Results. A total of 458 participants were included. At the 1-year follow-up, 48% of participants reported considerable neck pain, 53% disability, and 14% were still sick...
Gopal, S; Xu, H.(Institute of Modern Physics, Lanzhou, 730000, China); Bossie, C; Burón, J A; Fu, D J; Savitz, A; Nuamah, I.; Hough, D
Background To assess the tardive dyskinesia (TD) rate in studies of once-monthly long-acting injectable (LAI) paliperidone palmitate (PP) and once-daily oral paliperidone extended release (Pali ER). Methods Completed schizophrenia and bipolar studies for PP and Pali ER (≥ 6 month duration with retrievable patient-level data) were included in this post hoc analysis. Schooler–Kane research criteria were applied using Abnormal Involuntary Movement Scale (AIMS) scores to categorise probable (qual...
Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.
Full Text Available Abstract Background South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council conducted four phase III and one phase IIb trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated, with HIV prevalence between 25% and 45% and HIV incidence ranging from 4.5-9.1% per year. Unfortunately none of the interventions tested had any impact on reducing the risk of HIV acquisition; however, extremely valuable experience was gained, lessons learned and capacity built, while the communities gained associated benefits. Experience Our experience in conducting these trials ranged from setting up community partnerships to developing clinical research sites and dissemination of trial results. Community engagement included setting up community-based research sites with approval from both political and traditional leaders, and developing community advisory groups to assist with the research process. Community-wide education on HIV/sexually transmitted infection prevention, treatment and care was provided to over 90 000 individuals. Myths and misconceptions were addressed through methods such as anonymous suggestion boxes in clinic waiting areas and intensive education and counselling. Attempts were made to involve male partners to foster support and facilitate recruitment of women. Peer educator programmes were initiated to provide ongoing education and also to facilitate recruitment of women to the trials. Recruitment strategies such as door-to-door recruitment and community group meetings were initiated. Over 90% of women enrolled were retained. Community benefits from the trial included education on HIV prevention, treatment and care and provision of ancillary care (such as Pap smears, reproductive health care and
Nasrallah, Henry A.; Gopal, Srihari; Gassmann-Mayer, Cristiana; Quiroz, Jorge A.; Lim, Pilar; Eerdekens, Mariëlle; Yuen, Eric; Hough, David
Paliperidone palmitate is a long-acting injectable antipsychotic agent. This 13-week, multicenter, randomized (1 : 1 : 1 : 1), double-blind, parallel-group study evaluated the efficacy, safety, and tolerability of fixed 25, 50, and 100 milligram equivalent (mg equiv.) doses of paliperidone palmitate vs placebo administered as gluteal injections on days 1 and 8, then every 4 weeks (days 36 and 64) in 518 adult patients with schizophrenia. The intent-to-treat analysis set (N=514) was 67% men an...
Dooms, M; Chango, A; Barbour, E; Pouillart, P; Abdel Nour, A M
The "Minimum Information for the Publication of qPCR Experiments" (MIQE ) guidelines are very much targeted at basic research experiments and have to our knowledge not been applied to qPCR assays carried out in the context of clinical trials. This report details the use of the MIQE qPCR app for iPhone (App Store, Apple) to assess the MIQE compliance of one clinical and five pre-clinical trials. This resulted in the need to include 14 modifications that make the guidelines more relevant for the assessment of this special type of application. We also discuss the need for flexibility, since while some parameters increase experimental quality, they also require more reagents and more time, which is not always feasible in a clinical setting. PMID:22910527
Reddy, V; Jayne, D; Close, D.; Isenberg, D
B cells are believed to be central to the disease process in systemic lupus erythematosus (SLE), making them a target for new therapeutic intervention. In recent years there have been many publications regarding the experience in SLE of B-cell depletion utilising rituximab, an anti-CD20 mAb that temporarily depletes B cells, reporting promising results in uncontrolled open studies and in routine clinical use. However, the two large randomised controlled trials in extra-renal lupus (EXPLORER s...
Brienza, Rebecca S.; Whitman, Laura; Ladouceur, Lynnea; Green, Michael L.
Although intimate partner violence (IPV) remains a major public health problem, physicians often fail to screen female patients. Reported IPV training approaches suffer from weak study designs and limited outcome assessments. We hypothesized that an educational experience for residents at a women's safe shelter would have significantly greater impact on IPV competencies, screening, and care for victims than a workshop seminar alone. In a pre-post randomized controlled trial, we compared resid...
Kelly, Thomas M.; Daley, Dennis C; Byrne, Mimmie; DeMarzo, Larry; Smith, Doris; Madl, Stephanie
The National Institute on Drug Abuse (NIDA)-sponsored Clinical Trial Network (CTN) recently celebrated 10 years of conducting “real world” research into the treatment of addiction. This article reviews the history and results of the most recent CTN studies and describes the experiences of one of the 13 participating research affiliates, the Appalachian Tri-State (ATS) Node. We discuss our “bidirectional” collaboration with multiple community treatment programs (CTPs) on research and dissemina...
Full Text Available Abstract Whilst some populations have recently experienced dramatic declines in malaria, the majority of those most at risk of Plasmodium falciparum malaria still lack access to effective treatment with artemisinin combination therapy (ACT and others are already facing parasites resistant to artemisinins. In this context, there is a crucial need to improve both access to and targeting of ACT through greater availability of good quality ACT and parasitological diagnosis. This is an issue of increasing urgency notably in the private commercial sector, which, in many countries, plays an important role in the provision of malaria treatment. The Affordable Medicines Facility for malaria (AMFm is a recent initiative that aims to increase the provision of affordable ACT in public, private and NGO sectors through a manufacturer-level subsidy. However, to date, there is little documented experience in the programmatic implementation of subsidized ACT in the private sector. Cambodia is in the unique position of having more than 10 years of experience not only in implementing subsidized ACT, but also rapid diagnostic tests (RDT as part of a nationwide social marketing programme. The programme includes behaviour change communication and the training of private providers as well as the sale and distribution of Malarine, the recommended ACT, and Malacheck, the RDT. This paper describes and evaluates this experience by drawing on the results of household and provider surveys conducted since the start of the programme. The available evidence suggests that providers' and consumers' awareness of Malarine increased rapidly, but that of Malacheck much less so. In addition, improvements in ACT and RDT availability and uptake were relatively slow, particularly in more remote areas. The lack of standardization in the survey methods and the gaps in the data highlight the importance of establishing a clear system for monitoring and evaluation for similar initiatives
Full Text Available Abstract Background A new intervention aimed at managing patients with medically unexplained symptoms (MUS based on a specific set of communication techniques was developed, and tested in a cluster randomised clinical trial. Due to the modest results obtained and in order to improve our intervention we need to know the GPs' attitudes towards patients with MUS, their experience, expectations and the utility of the communication techniques we proposed and the feasibility of implementing them. Physicians who took part in 2 different training programs and in a randomised controlled trial (RCT for patients with MUS were questioned to ascertain the reasons for the doctors' participation in the trial and the attitudes, experiences and expectations of GPs about the intervention. Methods A qualitative study based on four focus groups with GPs who took part in a RCT. A content analysis was carried out. Results Following the RCT patients are perceived as true suffering persons, and the relationship with them has improved in GPs of both groups. GPs mostly valued the fact that it is highly structured, that it made possible a more comfortable relationship and that it could be applied to a broad spectrum of patients with psychosocial problems. Nevertheless, all participants consider that change in patients is necessary; GPs in the intervention group remarked that that is extremely difficult to achieve. Conclusion GPs positively evaluate the communication techniques and the interventions that help in understanding patient suffering, and express the enormous difficulties in handling change in patients. These findings provide information on the direction in which efforts for improving intervention should be directed. Trial registration US ClinicalTrials.gov NCT00130988
Diehl, William; Alex, Hoffinger; Weisstein, Ephraim
Describes background for school-to-work effort in Massachusetts, the state's design and implementation of the School-to-Work Opportunities Act (STWOA) of 1994, the local impact of the state's STWOA grant, challenges to making school-to-work a top priority of state education reform strategies to improve student achievement, and state and local…
Ebb, Nancy; And Others
This guide is designed to provide information about transitional child care (TCC) program policies and operations and to offer recommendations to policymakers and advocates. Transitional child care is a new federal child care program that every state must implement by April 1, 1990. Established by the Family Support Act (FSA) of 1988, TCC is…
George J. Benston; George G. Kaufman
In 1991, the U.S. adopted fundamental deposit insurance reform in the FDIC Improvement Act. This article reveals why such reform was necessary in light of the severe banking crisis of the 1980s and analyzes its success to date.
Bodenhoefer, K.; Schneider, A. [Sony International (Europe) GmbH (SIE), Stuttgart (Germany); Cock, T.; Brooks, A.; Sands, G. [Merloni Elletrodomestici, Stoke-on-Trent (United Kingdom); Allman, L.; Simon, M. [Sheffield Hallam Univ., Sheffield (United Kingdom); Chong, S.K.; Yang, K. [De Montfort Univ., Leicester (United Kingdom); Delannoy, O.; Catanese, B. [Cybernetix, Rousset (France); Mueller, K. [Motorola GmbH, Taunusstein (Germany)
An improved control of product life cycles enables a more sustainable use of resources. In the EU co-funded project ELIMA (Environmental Life Cycle Information Management and Acquisition for Consumer Products) both hard- and software tools are developed to record and manage reliable product life cycle data to improve service/repair and recycling/reuse as well as product design. Field trials with demonstrator products from two categories - consumer electronics and large household appliances - are running until August 2004. Data collection and general analysis is performed with the help of the internet-based ELIMA information management system. This paper describes the applied data acquisition and data management technologies and the field trials in which they are tested. First field trial results are presented both as a general data interpretation and as subsequent customer oriented analysis. Linked to this, user acceptance survey results from UK and Germany and the conclusions drawn are discussed. (orig.)
Arnold, Lesley M.; Bateman, Lucinda; Palmer, Robert H.; Lin, Yuhua
Background There are no approved medications for juvenile fibromyalgia (JFM), a disorder that is often under-diagnosed. The effects of milnacipran, a drug approved for the management of fibromyalgia (FM) in adults, was assessed in a clinical trial program for JFM. Methods Patients, ages 13–17 years who met the Yunus and Masi criteria for JFM and/or 1990 American College of Rheumatology criteria for FM, were enrolled in a responder-enriched, randomized withdrawal trial. After receiving open-la...
Full Text Available Abstract Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.
Giguere, Rebecca; Zimet, Gregory D; Kahn, Jessica A; Dolezal, Curtis; Leu, Cheng-Shiun; Mabragaña, Marina; McGowan, Ian; Carballo-Diéguez, Alex
Young women are an important target group in microbicide research, yet little is known about why they participate and stay in microbicide trials. Our study examined motivations for participating in a Phase I microbicide trial among 61 women ages 18 - 24 years in the continental USA and Puerto Rico. We also examined their perspectives on study participation. Participants underwent a semi-structured in-depth interview in which they were asked about factors that motivated enrollment and their experiences while participating. They also completed a Web-based Computer Assisted Self Interview in which they were asked to rate study burden (1 = low to 4 = high). Factors that motivated enrollment were altruism (29%), compensation (17%), a combination of altruism and compensation (37%) and free medical exams (17%). Factors that encouraged participants to stay in the study were study staff (95%), confirmation of good health (41%), and the opportunity to learn about their bodies (17%). Mean ratings of study burden ranged from 1.83 (having to travel to site) to 2.41 (colposcopy), indicating that participants were not highly bothered by visits or procedures. Although Phase I trials require invasive procedures, participants were not highly bothered by them and recognized them as necessary. Good relationships with staff and clear information about how procedures contribute to study goals may encourage participants to remain in trials. Young women may be motivated to enter microbicide trials by stressing the role they will play in discovering better HIV-prevention methods and highlighting the comprehensive preventive exams they will receive. PMID:24324918
Lashner, B A; Hanauer, S B; Silverstein, M D
Epidemiologic studies have documented an association between nonsmoking and ulcerative colitis and case reports have demonstrated that symptoms improve with smoking and worsen with removal of a nicotine source. A double-blind randomized crossover trial for individual ulcerative colitis patients (single-patient trial, or N of 1 clinical trial) was designed to study the safety, patient acceptance, and the effectiveness of nicotine gum in improving patient symptoms and proctoscopic appearance of involved colon. Seven nonsmoking patients chewed up to 10 squares/day (20 mg) of nicotine gum or placebo gum for two weeks. Therapy was crossed-over every two weeks over the eight-week trial. Effectiveness was judged from comparisons between nicotine-gum and placebo-gum periods of patient self-reported symptoms at the conclusion of each two-week period using visual analog scales and proctoscopic appearance using ordered categorical scales. Three of seven patients, all three of whom were former smokers, demonstrated sufficient improvement without adverse effects to warrant institution of nicotine gum into their drug treatment regimens. Three patients demonstrated an uncertain response, despite tolerating the drug, and have not had nicotine gum added to their regimens. One patient could not tolerate the medication and was withdrawn from the study. No serious side effects were noted. We conclude that a randomized trial for an individual patient is a useful method for evaluating treatment regimens for ulcerative colitis and that nicotine gum may be effective therapy for individual patients with ulcerative colitis who demonstrate an objective response with few adverse effects. PMID:2194767
Matthew D Campbell
Full Text Available To examine the metabolic, gluco-regulatory-hormonal and inflammatory cytokine responses to large reductions in rapid-acting insulin dose administered prandially before and after intensive running exercise in male type 1 diabetes patients.This was a single centre, randomised, controlled open label study. Following preliminary testing, 8 male patients (24±2 years, HbA1c 7.7±0.4%/61±4 mmol.l-1 treated with insulin's glargine and aspart, or lispro attended the laboratory on two mornings at ∼08:00 h and consumed a standardised breakfast carbohydrate bolus (1 g carbohydrate.kg-1BM; 380±10 kcal and self-administered a 75% reduced rapid-acting insulin dose 60 minutes before 45 minutes of intensive treadmill running at 73.1±0.9% VO2peak. At 60 minutes post-exercise, patients ingested a meal (1 g carbohydrate.kg-1BM; 660±21 kcal and administered either a Full or 50% reduced rapid-acting insulin dose. Blood glucose and lactate, serum insulin, cortisol, non-esterified-fatty-acids, β-Hydroxybutyrate, and plasma glucagon, adrenaline, noradrenaline, IL-6, and TNF-α concentrations were measured for 180 minutes post-meal.All participants were analysed. All glycaemic, metabolic, hormonal, and cytokine responses were similar between conditions up to 60 minutes following exercise. Following the post-exercise meal, serum insulin concentrations were lower under 50% (p<0.05 resulting in 75% of patients experiencing hyperglycaemia (blood glucose ≥8.0 mmol.l-1; 50% n = 6, Full n = 3. β-Hydroxybutyrate concentrations decreased similarly, such that at 180 minutes post-meal concentrations were lower than rest under Full and 50%. IL-6 and TNF-α concentrations remained similar to fasting levels under 50% but declined under Full. Under 50% IL-6 concentrations were inversely related with serum insulin concentrations (r = -0.484, p = 0.017.Heavily reducing rapid-acting insulin dose with a carbohydrate bolus before, and a meal after intensive
Full Text Available Abstract Background Paliperidone palmitate is a long-acting injectable atypical antipsychotic for the acute and maintenance treatment of adults with schizophrenia. The recommended initiation dosing regimen is 234 mg on Day 1 and 156 mg on Day 8 via intramuscular (deltoid injection; followed by 39 to 234 mg once-monthly thereafter (deltoid or gluteal. These post-hoc analyses addressed two commonly encountered clinical issues regarding the initiation dosing: the time to onset of efficacy and the associated tolerability. Methods In a 13-week double-blind trial, 652 subjects with schizophrenia were randomized to paliperidone palmitate 39, 156, or 234 mg (corresponding to 25, 100, or 150 mg equivalents of paliperidone, respectively or placebo (NCT#00590577. Subjects randomized to paliperidone palmitate received 234 mg on Day 1, followed by their randomized fixed dose on Day 8, and monthly thereafter, with no oral antipsychotic supplementation. The onset of efficacy was defined as the first timepoint where the paliperidone palmitate group showed significant improvement in the Positive and Negative Syndrome Scale (PANSS score compared to placebo (Analysis of Covariance [ANCOVA] models and Last Observation Carried Forward [LOCF] methodology without adjusting for multiplicity using data from the Days 4, 8, 22, and 36 assessments. Adverse event (AE rates and relative risks (RR with 95% confidence intervals (CI versus placebo were determined. Results Paliperidone palmitate 234 mg on Day 1 was associated with greater improvement than placebo on Least Squares (LS mean PANSS total score at Day 8 (p = 0.037. After the Day 8 injection of 156 mg, there was continued PANSS improvement at Day 22 (p ≤ 0.007 vs. placebo and Day 36 (p Conclusions Significantly greater symptom improvement was observed by Day 8 with paliperidone palmitate (234 mg on Day 1 compared to placebo; this effect was maintained after the 156 mg Day 8 injection, with a trend towards a dose
Rancaño, V.J.F.; Parmigiani, F.; Petropoulos, P.; Richardson, D. J.
A flexible modulation-, bit rate- independent and polarization insensitive wavelength converter based on a highly nonlinear fiber is demonstrated in the middle-point of a field trial transmission experiment.
This document describes the closure of the HTRE-3 Container Storage Unit under the requirements of the Resource Conservation and Recovery Act. The unit's location, size, history, and current status are described. The document also summarizes the decontamination and decommissioning efforts performed in 1983 and provides an estimate of,waste residues remaining in the HTRE-3 assembly. A risk evaluation was performed that demonstrates that the residue does not pose a hazard to public health or the environment. Based on the risk evaluation, it is proposed that the HTRE-3 Container Storage Unit be closed in its present condition, without further decontamination or removal activities
Thome, J; Doppler, E
The safety of Cerebrolysin has been shown through many years of clinical use, observations from postmarketing surveillance studies, and safety data from randomized, controlled clinical trials. The reported events showed that adverse reactions to Cerebrolysin were generally mild and transient. Most common adverse events included vertigo, agitation and feeling hot. In the controlled clinical trials analyzed for this report, the incidence of adverse events was similar in Cerebrolysin- and placebo-treated groups. Cerebrolysin seems to be safe when used in combination with recombinant tissue-type plasminogen activator or cholinesterase inhibitors such as donepezil or rivastigmine. To our knowledge, Cerebrolysin was not associated with major changes in vital signs or laboratory parameters. PMID:22514795
Mwangoka, Grace; Ogutu, Bernhards; Msambichaka, Beverly; Mzee, Tutu; Salim, Nahya; Kafuruki, Shubis; Mpina, Maxmillian; Shekalaghe, Seif; Tanner, Marcel; Abdulla, Salim
Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine. Researchers, clinical trialists and vaccine developers have been working on many approached to make malaria vaccine available.African research institutions have developed and demonstrated a great capacity to undertake clinical trials in accordance to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards in the last decade; particularly in the field of malaria vaccines and anti-malarial drugs. This capacity is a result of networking among African scientists in collaboration with other partners; this has traversed both clinical trials and malaria control programmes as part of the Global Malaria Action Plan (GMAP). GMAP outlined and support global strategies toward the elimination and eradication of malaria in many areas, translating in reduction in public health burden, especially for African children. In the sub-Saharan region the capacity to undertake more clinical trials remains small in comparison to the actual need.However, sustainability of the already developed capacity is essential and crucial for the evaluation of different interventions and diagnostic tools/strategies for other diseases like TB, HIV, neglected tropical diseases and non-communicable diseases. There is urgent need for innovative mechanisms for the sustainability and expansion of the capacity in clinical trials in sub-Saharan Africa as the catalyst for health improvement and maintained. PMID:23496910
Bull, S S; Vallejos, D; Levine, D; Ortiz, C
The objective of the study was to present recruitment and retention findings for an Internet based HIV prevention trial evaluated using a randomized controlled design among 15-25-year-olds accessing a website on the Internet. We used a combination of automated electronic and personalized approaches to increase and diversify recruitment, verify participant eligibility and increase retention. We posted 3.5 million banner advertisements, 9354 individuals clicked on the advertisement, 8950 completed an eligibility screener and 3298 a baseline survey; we flagged 675 of these as suspicious and enrolled 2623 individuals. Of these, 2082 (79%) completed a follow-up at one-month and 1398 (53%) completed a two-month follow-up. This retention rate is the highest we have seen for an Internet-based HIV-prevention trial. Our procedures can be replicated in other trials. We stress the importance of using a combination of automated and personalized techniques to increase enrollment, verify eligibility and promote retention. PMID:18777217
Subpoenas received for criminal trials related to homicides in Fulton County (Atlanta) Georgia were tracked in a computer database for an 18 month period in order to determine the proportion of forensic pathologist worktime required for testimony in homicide cases. The number of subpoenas received annually amounted to 64% of the average number of homicides occurring annually. Testimony was required in about 33% of cases in which a subpoena was received, and, therefore, the number of testimony appearances per year was about 21% of the average annual number of homicides. Assuming a 40 hour work week for 52 weeks per year and an average of 3 hours of time preparing for, traveling to, and testifying in court, the time required of the forensic pathologist to testify in homicide trials amounted to about 2% of a full-time-equivalent. Although the time required for testimony in homicide cases may vary among jurisdictions because of the nature of its homicides, distance and travel time to court, and other factors, the data presented here may be used to estimate the impact of homicide trial court time on forensic pathology practice. PMID:9144948
Supplementing earlier reports on ways to provide financial protection against the potential hazards involved in the production of nuclear energy by analyzing the issues raised in the Silkwood v. Kerr-McGee Corporation decision, the author explores the impact of the case on the availability of funds to compensate the public and any increased exposure of the nuclear industry or the federal government to public liability. She concludes that the decision will have a significant impact on the day-to-day administration of claims, and could lead to higher premiums. The court would have to determine the priority given to claims in the event of a catastrophic accident, in which case the only significant impact would be under amendments to the Price-Anderson Act which resulted in elimination of its coverage or a substantial increase in or elimination of the limitation on liability
Gray, K. L.
The purpose of this article is to illustrate how minority gamers, particularly African-American males, are subject to the label of deviant within the virtual gaming community of Xbox Live. They are labeled deviant based on the stigma of their physical identity - blackness, through a process of linguistic profiling. By employing virtual ethnography, the author identifies a process that leads to racism based on how the black gamer sounds within the space. The act of racism emerges through a process involving questioning, provoking, instigating, and ultimately racism. Many black gamers have normalized these racist experiences and have accepted the label of deviant placed upon their bodies.
Price, Eunice; Wardman, Janna; Bruce, Toni; Millward, Pam
Facebook is a frequently accessed social networking site with more than one billion active users worldwide. Although there are numerous studies on its impact on teenagers, none have investigated its impact on gifted and talented girls. This study's aim was to understand the social media experiences of talented female student leaders. A qualitative…
Nørskov, Anders Kehlet
, using state of the art methodology, in order to test the clinical impact of using the SARI for preoperative airway assessment compared with a clinical judgement based on usual practice for airway assessment. Finally, to test if implementation of the SARI would reduce the proportion of unanticipated...... techniques in SARI departments reached statistical significance, p = 0.29 and p = 0.06 respectively. The papers constituting this thesis demonstrate that at high proportion of airway management difficulties are unanticipated. In a cluster randomised trial it was not possible to reduce the proportion of...
Børrestad, Line Anita Bjørkelund; Østergaard, Lars; Andersen, Lars Bo; Bere, Elling
Aims: The objective of the present study was to investigate the effect of a 12-week randomised controlled cycling-to-school trial on cardiorespiratory fitness. Methods: A total of 53 10- to 13-year-old children from one public school were included. The children were randomised into either a cycling group or a control group. The cycling group was encouraged to cycle to and from school each day during a period of 12 weeks. Peak oxygen consumption (VO2peak) and anthropometrical data (weight and ...
Full Text Available Abstract Background The Estonian Postmenopausal Hormone Therapy (EPHT Trial assigned 4170 potential participants prior to recruitment to blind or non-blind hormone therapy (HT, with placebo or non-treatment the respective alternatives. Before having to decide on participation, women were told whether they had been randomised to the blind or non-blind trial. Eligible women who were still willing to join the trial were recruited. After recruitment participants in the non-blind trial (N = 1001 received open-label HT or no treatment, participants in the blind trial (N = 777 remained blinded until the end of the trial. The aim of this paper is to analyse the effect of blinding on internal and external validity of trial outcomes. Methods Effect of blinding was calculated as the hazard ratio of selected chronic diseases, total mortality and all outcomes. For analysing the effect of blinding on external validity, the hazard ratios from women recruited to the placebo arm and to the non-treatment arm were compared with those not recruited; for analysing the effect of blinding on internal validity, the hazard ratios from the blind trial were compared with those from the non-blind trial. Results The women recruited to the placebo arm had less cerebrovascular disease events (HR 0.43; 95% CI: 0.26-0.71 and all outcomes combined (HR 0.76; 95% CI: 0.63-0.91 than those who were not recruited. Among women recruited or not recruited to the non-treatment arm, no differences were observed for any of the outcomes studied. Among women recruited to the trial, the risk for coronary heart disease events (HR 0.77; 95% CI: 0.64-0.93, cerebrovascular disease events (HR 0.66; 95%CI: 0.47-0.92, and all outcomes combined (HR 0.82; 95% CI: 0.72-0.94 was smaller among participants in the blind trial than in the non-blind trial. There was no difference between the blind and the non-blind trial for total cancer (HR 0.95; 95% CI: 0.64-1.42, bone fractures (0.93; 95% CI: 0
R V Rozhivanov
The paper outlines the author's experience on the efficacy and safety of androgen therapy of metabolic syndrome and obesity in men with hypogonadism. The study used testosterone undecanoate therapy that reduced body fat and the severity of the other components of the metabolic syndrome, improved sexual function without causing severe side effects. A number of patients on therapy observed suppression of spermatogenesis, which prevents the use of the drug in the reproductive rehabilitation.
R V Rozhivanov
Full Text Available The paper outlines the author's experience on the efficacy and safety of androgen therapy of metabolic syndrome and obesity in men with hypogonadism. The study used testosterone undecanoate therapy that reduced body fat and the severity of the other components of the metabolic syndrome, improved sexual function without causing severe side effects. A number of patients on therapy observed suppression of spermatogenesis, which prevents the use of the drug in the reproductive rehabilitation.
Schulze, R.H. [Trinity Consultants Incorporated, Dallas, TX (United States)
Twenty-five years ago, the United States embarked on a quest to attain clean air. President Nixon, in signing the Clean Air Act of 1970, defined clean air as the objective for the `70s. Although enormous progress has been made, much remains to be done. Newly constructed industry is quite clean, but many older facilities continue to operate with antiquated controls. Significant advances have been made in cleaning up the emissions from new automobiles, but two factors have impaired progress. First, cars last longer than they did in 1970, so the average age of the fleet has increased. Second, travel has increased as people have moved to the suburbs. Thus, the emission decreases from clean cars have not been as great as expected. This presentation will address some of the lessons learned from the efforts in the United States to implement clean air programs. In a large number of countries, excessively elaborate studies have been substituted for action programs. Since much is now known about air quality, fairly brief studies can define programs that should be undertaken. What may take longer is developing public support and enthusiasm for improved air quality. In most cases, it is desirable to reduce spending on studies and increase spending on devising and implementing plans, as well as effectively communicating the necessary changes to the public. Balanced spending on studies- and action programs is essential to a sound air quality control program. (author)
Formal waste management services are not accessible for the majority of primary healthcare clinics on the African continent, and affordable and practicable technology solutions are required in the developing country context. In response, a protocol was established for the first quantitative and qualitative evaluation of relatively low cost small-scale incinerators for use at rural primary healthcare clinics. The protocol comprised the first phase of four, which defined the comprehensive trials of three incineration units. The trials showed that all of the units could be used to render medical waste non-infectious, and to destroy syringes or render needles unsuitable for reuse. Emission loads from the incinerators are higher than large-scale commercial incinerators, but a panel of experts considered the incinerators to be more acceptable compared to the other waste treatment and disposal options available in under-serviced rural areas. However, the incinerators must be used within a safe waste management programme that provides the necessary resources in the form of collection containers, maintenance support, acceptable energy sources, and understandable operational instructions for the incinerators, whilst minimising the exposure risks to emissions through the correct placement of the units in relation to the clinic and the surrounding communities. On-going training and awareness building are essential in order to ensure that the incinerators are correctly used as a sustainable waste treatment option
Meeinkuirt, Weeradej; Pokethitiyook, Prayad; Kruatrachue, Maleeya; Tanhan, Phanwimol; Chaiyarat, Rattanawat
The potential of 6 tree species (Leucaena leucocephala, Acacia mangium, Peltophorum pterocarpum, Pterocarpus macrocarpus, Lagerstroemia floribunda, Eucalyptus camaldulensis) for phytoremediation of Pb in sand tailings (total Pb >9850 mg kg(-1)) from KEMCO Pb mine in Kanchanaburi province, Thailand, were investigated employing a pot experiment (3 months) and field trial experiment (12 months). In pot study E. camaldulensis treated with Osmocote fertilizer attained the highest total biomass (15.3 g plant(-1)) followed by P. pterocarpum (12.6 g plant(-1)) and A. mangium (10.8 g plant(-1)) both treated with cow manure. Cow manure application resulted in the highest root Pb accumulation (>10000 mg kg(-1)) in L. floribunda and P. macrocarpus. These two species also exhibited the highest Pb uptake (85-88 mg plant(-1)). Results from field trial also showed that Osmocote promoted the best growth performance in E. camaldulensis (biomass 385.7 g plant(-1), height 141.7 cm) followed by A. mangium (biomass 215.9 g plant(-1), height 102.7 cm), and they also exhibited the highest Pb uptake (600-800 microg plant(-1)). A. mangium with the addition of organic fertilizer was the best option for phytostabilization of Pb-contaminated mine tailing because it retained higher Pb concentration in the roots. PMID:22908655
Watson Susan B
Full Text Available Abstract Background In a recently published 24-week maintenance study of olanzapine long-acting injection (LAI in schizophrenia (Kane et al., 2010, apparent dose-associated changes were noted in both efficacy and safety parameters. To help clinicians balance safety and efficacy when choosing a dose of olanzapine LAI, we further studied these changes. Methods Outpatients with schizophrenia who had maintained stability on open-label oral olanzapine for 4 to 8 weeks were randomly assigned to "low" (150 mg/2 weeks; N = 140, "medium" (405 mg/4 weeks; N = 318, or "high" (300 mg/2 weeks; N = 141 dosages of olanzapine LAI for 24 weeks. Potential relationships between dose and several safety or efficacy measures were examined via regression analysis, the Jonckheere-Terpstra test (continuous data, or the Cochran-Armitage test (categorical data. Results Safety parameters statistically significantly related to dose were mean weight change (low: +0.67 [SD = 4.38], medium: +0.89 [SD = 3.87], high: +1.70 [SD = 4.14] kg, p = .024; effect size [ES] = 0.264 high vs. low dose, mean change in prolactin (low: -5.61 [SD = 12.49], medium: -2.76 [SD = 19.02], high: +3.58 [SD = 33.78] μg/L, p = .001; ES = 0.410 high vs. low dose, fasting triglycerides change from normal at baseline to high (low: 3.2%, medium: 6.0%, high: 18.9%, p = .001; NNT = 7 high vs. low dose and fasting high-density lipoprotein cholesterol change from normal at baseline to low (low: 13.8%, medium: 19.6%, high: 30.7%, p = .019; NNT = 6 high vs. low dose. Efficacy measures significantly related to dose included Positive and Negative Syndrome Scale total score mean change (low: +2.66 [SD = 14.95], medium: -0.09 [SD = 13.47], high: -2.19 [SD = 13.11], p Conclusions Analyses of several safety and efficacy parameters revealed significant associations with dose of olanzapine LAI, with the highest dose generally showing greater efficacy as well as greater adverse changes in metabolic safety measures. When
Nørskov, Anders Kehlet
Difficulties with airway management in relation to general anaesthesia have been a challenge for the anaesthesiologist since the birth of anaesthesia. Massive landmark improvements have been made and general anaesthesia is now regarded as a safe procedure. However, rare, difficult airway management still occurs and it prompts increased risk of morbidity and mortality - especially when not anticipated. Several preoperative risk factors for airway difficulties have been identified, yet none have convincing diagnostic accuracy as stand alone tests. Combining several risk factors increase the predictive value of the test and multivariable risk models have been developed. The Simplified Airway Risk Index (SARI) is a predictive model developed for anticipation of a difficult direct laryngoscopy. However, neither the diagnostic accuracy of the SARI nor of any other model has been tested prospectively and compared with existing practice for airway assessment in a randomised trial setting. The first objective of this thesis was to quantify the proportion of unanticipated difficult intubation and difficult mask ventilation in Denmark. The second objective was to design a cluster randomised trial, using state of the art methodology, in order to test the clinical impact of using the SARI for preoperative airway assessment compared with a clinical judgement based on usual practice for airway assessment. Finally, to test if implementation of the SARI would reduce the proportion of unanticipated difficult intubation compared with usual care for airway assessment. This thesis is based on data from the Danish Anaesthesia Database (DAD). Paper 1 presents an observational cohort study on 188,064 patients who underwent tracheal intubation from 2008 to 2011. Data on the anaesthesiologists' preoperative anticipations of airway difficulties was compared with actual airway management conditions, thus enabling an estimation of the proportion of unanticipated difficulties with intubation
Mallmann, Marly Terezinha; Daudt, Sônia Isabel Dondonis
In this article we present the process of creation of an innovative proposal for undergraduate teaching, developed by an interdisciplinary group at "Universidade do Vale do Rio dos Sinos--UNISINOS". Besides pointing out the theoretical-epistemological referential supporting this proposal, we will also be discussing the implications some paradigm ruptures have brought to the educational process presently being used at this University. We would like to introduce the reader to the process behind this way of understanding and living the educational practice, as well as to follow the account of an experience a group of teachers has had, when confronted with the task of pondering a new undergraduate program. PMID:14699751
de Groot, Mattijs; Field, Robert W; Buma, Wybren J
We report on an experimental approach that reveals crucial details of the composition of singlet-triplet mixed eigenstates in acetylene. Intersystem crossing in this prototypical polyatomic molecule embodies the mixing of the lowest excited singlet state (S(1)) with 3 triplet states (T(1), T(2), and T(3)). Using high-energy (157-nm) photons from an F(2) laser to record excited-state photoelectron spectra, we have decomposed the mixed eigenstates into their S(1), T(3), T(2), and T(1) constituent parts. One example of the interpretive power that ensues from the selective sensitivity of the experiment to the individual electronic state characters is the discovery and examination of destructive interference between two doorway-mediated intersystem crossing pathways. This observation of an interference effect in nonradiative decay opens up possibilities for rational coherent control over molecular excited state dynamics. PMID:19179288
Full Text Available BACKGROUND: HIV vaccine trials generally require that pregnant women are excluded from participation, and contraceptive methods must be used to prevent pregnancy during the trial. However, access to quality services and misconceptions associated with contraceptive methods may impact on their effective use in developing countries. We describe the pattern of contraceptive use in a multi-site phase I/IIa HIV Vaccine trial in East Africa (Uganda, Kenya and Tanzania and factors that may have influenced their use during the trial. METHODS: Pregnancy prevention counseling was provided to female participants during informed consent process and at each study visit. Participants' methods of contraception used were documented. Methods of contraceptives were provided on site. Pregnancy testing was done at designated visits during the trial. Obstacles to contraceptive use were identified and addressed at each visit. RESULTS: Overall, 103 (31.8% of a total of 324 enrolled volunteers were females. Female participants were generally young with a mean age of 29(+/-7.2, married (49.5% and had less than high school education (62.1%. Hormonal contraceptives were the most common method of contraception (58.3% followed by condom use (22.3%. The distribution of methods of contraception among the three sites was similar except for more condom use and less abstinence in Uganda. The majority of women (85.4% reported to contraceptive use prior to screening. The reasons for not using contraception included access to quality services, insufficient knowledge of certain methods, and misconceptions. CONCLUSION: Although hormonal contraceptives were frequently used by females participating in the vaccine trial, misconceptions and their incorrect use might have led to inconsistent use resulting in undesired pregnancies. The study underscores the need for an integrated approach to pregnancy prevention counseling during HIV vaccine trials. TRIAL REGISTRATION: ClinicalTrials
Full Text Available BACKGROUND: Guided internet-delivered cognitive behavior therapy (ICBT has been tested in several trials on social anxiety disorder (SAD with moderate to large effects. The aims of this study were threefold. First, to compare the effects of ICBT including online discussion forum with a moderated online discussion forum only. Second, to investigate if knowledge about SAD increased following treatment and third to compare the effects of inexperienced versus experienced therapists on patient outcomes. METHODS: A total of 204 participants with a primary diagnosis of SAD were included and randomized to either guided ICBT or the control condition. ICBT consisted of a 9-week treatment program which was guided by either psychology students at MSc level (n = 6 or by licensed psychologists with previous experience of ICBT (n = 7. A knowledge test dealing with social anxiety was administered before and after treatment. Measures of social anxiety and secondary outcomes dealing with general anxiety, depression, and quality of life were administered before and after treatment. In addition, a 1-year follow-up was conducted on the treated individuals. RESULTS: Immediately following treatment, the ICBT group showed superior outcome on the Liebowitz Social Anxiety Scale self-report version with a between group posttreatment Hedges g effect size of g = 0.75. In addition, significant differences on all the secondary outcomes were observed. Gains were well maintained one year later. Knowledge, as assessed by the knowledge test, increased following treatment with little gain in the control group. Therapist experience did not result in different outcomes, but experienced therapists logged in less frequently compared to the inexperienced therapists, suggesting that they needed less time to support patients. DISCUSSION: We conclude that guided ICBT reduce symptoms of SAD, increase knowledge about SAD and that therapist experience does not make a difference
Zhao, Wenle; Waldman, Bonnie D; Dillon, Catherine; Pauls, Keith; Kim, Jaemyung; Patterson, Lynn; Ginsberg, Myron D; Hill, Michael D; Palesch, Yuko
An electronic safety reporting (ESR) module was developed and integrated into a home-grown web-based clinical trial management system (CTMS) to enhance the efficiency, completeness and consistency of reporting and reviewing serious adverse events, monitoring safety, and submitting safety reports to regulatory authorities for a large multicenter clinical trial. The architecture of this integrated module provided many advantages. First, the ESR module was developed based on a comprehensive procedure which incorporated both computer logic processing steps and human intervention steps in order to deal with the complex and unexpected situations where pre-programmed computer logic may fail. Second, safety and efficacy data were managed within the same relational database. Relevant data captured on efficacy case report forms, such as demographics, medical history, lab data and concomitant medications, were directly retrievable for MedWatch report composition without requiring redundant data entry. Finally, the ESR module shared the same generic user interfaces and data processing functions with other modules in the CTMS. These generic components include data editing, data retrieving, data reporting, dictionary-based automatic and interactive coding, event-driven and calendar-driven automatic email notifications, and user privilege management. This integrated ESR module was implemented in the Albumin in Acute Stroke (ALIAS) Trial-Part 1. A total of 397 serious adverse event reports were processed and 33 FDA MedWatch reports, 28 initial reports, and 5 follow-up reports were submitted to FDA and Health Canada using this system. Experiences and lessons learned from the development and implementation of this system are presented in this paper. PMID:20828636
Full Text Available Abstract Data quality assurance and quality control are critical to the effective conduct of a clinical trial. In the present commentary, we discuss our experience in a large, multicenter stroke trial. In addition to standard data quality control techniques, we have developed novel methods to enhance the entire process. Central to our methods is the use of clinical monitors who are trained in the techniques of data monitoring.
Felton, Annika M; Felton, Adam; Raubenheimer, David; Simpson, Stephen J; Krizsan, Sophie J; Hedwall, Per-Ola; Stolter, Caroline
The nutrient balancing hypothesis proposes that, when sufficient food is available, the primary goal of animal diet selection is to obtain a nutritionally balanced diet. This hypothesis can be tested using the Geometric Framework for nutrition (GF). The GF enables researchers to study patterns of nutrient intake (e.g. macronutrients; protein, carbohydrates, fat), interactions between the different nutrients, and how an animal resolves the potential conflict between over-eating one or more nutrients and under-eating others during periods of dietary imbalance. Using the moose (Alces alces L.), a model species in the development of herbivore foraging theory, we conducted a feeding experiment guided by the GF, combining continuous observations of six captive moose with analysis of the macronutritional composition of foods. We identified the moose's self-selected macronutrient target by allowing them to compose a diet by mixing two nutritionally complementary pellet types plus limited access to Salix browse. Such periods of free choice were intermixed with periods when they were restricted to one of the two pellet types plus Salix browse. Our observations of food intake by moose given free choice lend support to the nutrient balancing hypothesis, as the moose combined the foods in specific proportions that provided a particular ratio and amount of macronutrients. When restricted to either of two diets comprising a single pellet type, the moose i) maintained a relatively stable intake of non-protein energy while allowing protein intakes to vary with food composition, and ii) increased their intake of the food item that most closely resembled the self-selected macronutrient intake from the free choice periods, namely Salix browse. We place our results in the context of the nutritional strategy of the moose, ruminant physiology and the categorization of food quality. PMID:26986618
Annika M Felton
Full Text Available The nutrient balancing hypothesis proposes that, when sufficient food is available, the primary goal of animal diet selection is to obtain a nutritionally balanced diet. This hypothesis can be tested using the Geometric Framework for nutrition (GF. The GF enables researchers to study patterns of nutrient intake (e.g. macronutrients; protein, carbohydrates, fat, interactions between the different nutrients, and how an animal resolves the potential conflict between over-eating one or more nutrients and under-eating others during periods of dietary imbalance. Using the moose (Alces alces L., a model species in the development of herbivore foraging theory, we conducted a feeding experiment guided by the GF, combining continuous observations of six captive moose with analysis of the macronutritional composition of foods. We identified the moose's self-selected macronutrient target by allowing them to compose a diet by mixing two nutritionally complementary pellet types plus limited access to Salix browse. Such periods of free choice were intermixed with periods when they were restricted to one of the two pellet types plus Salix browse. Our observations of food intake by moose given free choice lend support to the nutrient balancing hypothesis, as the moose combined the foods in specific proportions that provided a particular ratio and amount of macronutrients. When restricted to either of two diets comprising a single pellet type, the moose i maintained a relatively stable intake of non-protein energy while allowing protein intakes to vary with food composition, and ii increased their intake of the food item that most closely resembled the self-selected macronutrient intake from the free choice periods, namely Salix browse. We place our results in the context of the nutritional strategy of the moose, ruminant physiology and the categorization of food quality.
Tanhan, Phanwimol; Pokethitiyook, Prayad; Kruatrachue, Maleeya; Chaiyarat, Rattanawat; Upatham, Suchart
Greenhouse and field trial experiments were performed to evaluate the use of Chromolaena odorata with various soil amendments for phytoextraction of Pb contaminated soil Pb mine soils contain low amount of nutrients, so the additions of organic (cow manure) and inorganic (Osmocote and NH4NO3 and KCl) fertilizers with EDTA were used to enhance plant growth and Pb accumulation. Greenhouse study showed that cow manure decreased available Pb concentrations and resulted in the highest Pb concentration in roots (4660 mg kg(-1)) and shoots (389.2 mg kg(-1)). EDTA increased Pb accumulation in shoots (17-fold) and roots (11-fold) in plants grown in soil with Osmocote with Pb uptake up to 203.5 mg plant(-1). Application of all fertilizers had no significant effects on relative growth rates of C. odorata. Field trial study showed that C. odorata grown in soil with 99545 mg kg(-1) total Pb accumulated up to 3730.2 and 6698.2 mg kg(-1) in shoots and roots, respectively, with the highest phytoextraction coefficient (1.25) and translocation factor (1.18). These results indicated that C. odorata could be used for phytoextraction of Pb contaminated soil. In addition, more effective Pb accumulation could be enhanced by Osmocote fertilizer. However, the use of EDTA in the field should be concerned with their leaching problems. PMID:21972512
Eisenkopf, Gerald; Sulser, Pascal A.
The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…
Recent advances in pharmacological and mechanical approaches to acute coronary syndromes have led to rapid changes in the management of patients admitted with acute coronary syndromes. These changes have been mirrored by the appearance of newer highly specific biochemical markers of myocardial damage particularly the cardiac troponins. When new biochemical markers become available it is the responsibility of the clinical chemist to evaluate them critically in terms of sensitivity, specificity, efficiency and analyzer precision, in the rigid setting of quality control that laboratories practise, and to compare them with other markers. When the data are shown to Clinical Cardiologists with supporting statements such as 'useful management tool' and 'can be used for early diagnosis of Myocardial Infarction', a different set of questions may need to be answered. The 'So what?' response is most frequent and is the most important hurdle that these newer biochemical markers have to overcome to convince physicians to change their current practice. This presentation will review the results of studies that have examined the potential clinical usefulness of the cardiac troponins with respect to diagnosis and risk stratification of patients admitted with suspected acute coronary syndromes. Any troponin variable that survives the 'so what' question has one further major hurdle to overcome. This is the requirement to inform physicians what different therapeutic strategies they should follow if the variable is present. Available clinical trial evidence about differing management options for patients according to their troponin status will be reviewed and outline management algorithms will be presented. Many questions remain unanswered and these will be included at the time points where they may be relevant. PMID:9857942
Full Text Available Abstract Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions
Austad, Åshild; Forså, Marianne Inngjerdingen
Objective: To assess whether following a standardized exercise program during pregnancy affects women’s experience of labor.Methods: 855 healthy pregnant women were randomized to an intervention or a control group. The intervention group followed a 12 weeks standardized exercise program between gestational weeks 20 and 36. The program included aerobic and strengthening exercises of moderate to high-intensity. The control group followed standard antenatal care. At inclusion and three months po...
Clare Louise Rhoden; Julia West; Andrew Renfree; Mark Corbett; Alan St Clair Gibson
Self-regulation research analyses behaviour and emotion through goal progress (Carver and Scheier 2013). Goal disengagement is advocated as an adaptive self-regulatory strategy for unattainable goals to reduce distress (Wrosch et al. 2003a; 2003b). In an attempt to further understand ongoing goal pursuit and emotions on endurance athletes, this paper applies adaptive self-regulation theory to interpret and explain the experiences of three cyclists in case studies which display variations in s...
Seng-Fah Tong; Chirk-Jenn Ng; Boon-Cheok Lee; Verna-KM Lee; Ee-Ming Khoo; Eng-Giap Lee; Hui-Meng Tan
This study aimed to investigate the effect of intramuscular injection of testosterone undecanoate on overall quality of life (QoL) in men with testosterone deficiency syndrome (TDS).A randomized controlled trial over a 12-month period was carried out in 2009.One hundred and twenty men aged 40 years and above with a diagnosis of TDS (serum total testosterone ＜ 12 nmol l-1 and total Aging Male Symptom (AMS) scores ≥ 27) were invited to participate.Interventions comprised intramuscular injection of either placebo or 1000 mg testosterone undecanoate,given at weeks 0,6,18,30 and 42.This paper presents the secondary analysis of QoL changes measured in the scores of Short-Form-12 (SF-12) scale at baseline,weeks 30 and 48 after the first injection.A total of 56/60 and 58/60 men from the active treatment and placebo group,respectively,completed the study.At week 48,before adjusting for baseline differences,the QoL of men in the treatment group improved significantly in five out of the eight domains on SF-12.The physical health composite scores improved 4.0 points from a baseline of 41.9±7.0 in the treatment group compared to 0.8 point from a baseline of 43.7±7.1 in the placebo group (F=3.652,P=0.027).The mental health composite scores improved 4.4 points from a baseline of 37.1±9.0 in the treatment group compared to 1.0 points from a baseline of 37.6±7.9 in the placebo group (F=4.514,P=0.018).After adjusting for baseline differences,significant improvement was observed in mental health composite scores,but not in physical health composite scores.Long-acting testosterone undecanoate significantly improved the mental health component of QoL in men with TDS.
Full Text Available This paper explores the role that societal culture may play in terms of acting as an inhibitor or enabler when creating conditions conducive to innovative enterprise. To further understanding of this concept, the paper's authors explore different cultural influences and traditions of the country of Germany and the Canadian province of Ontario against the backdrop of the introduction of a government green energy policy and how local business reacts to new opportunities forthcoming from this shift in policy direction. The authors contend that the current Ontario psyche has contributed to an overall cultural drag on innovative activities. They demonstrate that in no place is this cultural impact more evident than the apparent lack of home-grown innovative activity surrounding green energy entrepreneurship; where, in spite of progressive and favourable provincial government policy, continued manufacturing growth is led by offshore companies The Ontario experience is in sharp contrast to current and historical German activity, when it comes to local innovation and advances in green energy. While Germany officially enacted their green energy act at the turn of the last century, experts agree that the German tenure with going green is in fact 35 to 40 years in the making. Although it has been contended that unique historical conditions such as postwar reconstruction and the reunification of the former East and West Germany have been significant contributing factors to Germany's embracing of sustainable energy, the authors of this paper contend that cultural factors such as the German sense of naturfreund; an overwhelming sense of being a nature-lover, may also play a significant role. In their exploration the authors build upon Hofstede's cultural dimension theory unpacking specific cultural components, as they compare actions and responses made by German and Ontarian policy-makers and business decision-makers.
Background and purpose: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). Materials and methods: Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. Results: Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than ±10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P=0.44). Conclusions: QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation
Full Text Available Abstract Background Polycystic liver disease (PLD is defined as having more than 20 liver cysts and can present as a severe and disabling condition. Most symptoms are caused by the mass effect of the liver size and include abdominal pain and distension. The somatostatin analogues octreotide and lanreotide have proven to reduce polycystic liver volume. mTOR inhibitors such as everolimus inhibit cell proliferation and might thereby reduce growth of liver cysts. This trial aims to assess the benefit of combination therapy of everolimus and octreotide compared to octreotide monotherapy. In this study we present the structure of the trial and the characteristics of the included patients. Methods/design This is a randomized open-label clinical trial comparing the effect of 12 months of everolimus and octreotide to octreotide monotherapy in PLD patients. Primary outcome is change in liver volume determined by CT-volumetry. Secondary outcomes are changes in abdominal symptoms and quality of life. Moreover, safety and tolerability of the drugs will be assessed. Discussion This trial will compare the relative efficacy of combination therapy with octreotide and everolimus to octreotide monotherapy. Since they apply to different pathways of cystogenesis we expect that combining octreotide and everolimus will result in a cumulative reduction of polycystic liver volume. Trial registration number ClinicalTrials.gov: NCT01157858
From about 1880 to 1920, a culture of medical experimentation promoted blood transfusion as a therapy for severe anemia in Europe, which was applied in German East Africa in 1892 for a case of blackwater fever, a complication of malaria afflicting mainly Europeans. This first case of blood transfusion in Africa, in which an African's blood was transfused into a German official, complicates the dominant narrative that blood transfusions in Africa came only after World War I. Medical researchers moreover experimented with blood serum therapies on human and animal subjects in Europe and Africa, injecting blood of different species, "races" and ethnicities into others to demonstrate parasite transmissibility and to discover vaccines for diseases such as malaria, sleeping sickness, and yellow fever. While research in German colonies is highlighted here, this was a transnational medical culture that crossed borders and oceans. This research is of interest as a possible early pathway for the epidemic spread of HIV and other zoonoses in Africa and the world, which biomedical researchers have identified as emerging in West-Central Africa sometime around the turn of the twentieth century. PMID:26514397
Sevigny, Jeff; Suhy, Joyce; Chiao, Ping; Chen, Tianle; Klein, Gregory; Purcell, Derk; Oh, Joonmi; Verma, Ajay; Sampat, Mehul; Barakos, Jerome
Amyloid positron emission tomography (PET) imaging is being investigated as a screening tool to identify amyloid-positive patients as an enrichment strategy for Alzheimer disease (AD) clinical trial enrollment. In a multicenter, phase 1b trial, patients meeting clinical criteria for prodromal or mild AD underwent florbetapir PET scanning at screening. PET, magnetic resonance imaging, and coregistered PET/magnetic resonance imaging scans were reviewed by 2 independent readers and binary visual readings tabulated. Semiquantitative values of cortical to whole cerebellar standard uptake value ratios were computed (threshold 1.10). Of 278 patients with an evaluable PET scan, 170 (61%) and 185 (67%) were amyloid-positive by visual reading and quantitative analysis, respectively; 39% were excluded from the study due to an amyloid-negative scan based on visual readings. More ApoE ε4 carriers than noncarriers were amyloid-positive (80% vs. 43%). Comparison of visual readings with quantitative results identified 21 discordant cases (92% agreement). Interreader and intrareader agreements from visual readings were 98% and 100%, respectively. Amyloid PET imaging is an effective and feasible screening tool for enrollment of amyloid-positive patients with early stages of AD into clinical trials. PMID:26885819
Full Text Available Abstract Background While many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported. Methods Semi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16, three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent analysis from three researchers was employed to ensure methodological rigour. Participant’s experiences were categorised as “positive” or “negative” and a Chi Square analysis was then applied to each of the experiential themes, to compare experiences between the multivitamin and placebo groups, (subdividing the groups by gender. Usual experiences were categorised and discussed separately. Results Of the 182 participants enrolled, 116 completed the study and qualitative data were available from 114 participants. Thematic analysis revealed significant effects in favour of the multivitamin over placebo for participants experiencing increased energy levels (p=.022 and enhanced mood (p=.027. The beneficial effect on energy levels was particularly evident among female participants. A trend was found for participants reporting better sleep in the multivitamin over placebo. The multivitamin and placebo groups did not significantly differ in perceived positive or negative effects in areas relating to other aspects of mental function or physical health. No significant negative effects were revealed, although there was a non-significant trend for more people in the multivitamin
DeWard, Stephanie J; Wilson, Ashley; Bausell, Heather; Volz, Ashley S; Mooney, Kimberly
Bringing treatments for rare genetic diseases to patients requires clinical research. Despite increasing activism from patient support and advocacy groups to increase access to clinical research studies, connecting rare disease patients with the clinical research opportunities that may help them has proven challenging. Chief among these challenges are the low incidence of these diseases resulting in a very small pool of known patients with a particular disease, difficulty of diagnosing rare genetic diseases, logistical issues such as long distances to the nearest treatment center, and substantial disease burden leading to loss of independence. Using clinical studies of phenylketonuria as an example, this paper discusses how, based on the authors' collective experience, partnership among clinicians, patients, study coordinators, genetic counselors, dietitians, industry, patient support groups, and families can help overcome the challenges of recruiting and retaining patients in rare disease clinical trials. We discuss specific methods of collaboration, communication, and education as part of a long-term effort to build a community committed to advancing the medical care of patients with rare genetic diseases. By talking to patients and families regularly about research initiatives and taking steps to make study participation as easy as possible, rare disease clinic staff can help ensure adequate study enrollment and successful study completion. PMID:24014152
Cordeira, L Shulman; Pednekar, M S; Nagler, E M; Gautam, J; Wallace, L; Stoddard, A M; Gupta, P C; Sorensen, G C
This article provides an overview of the recruitment strategies utilized in the Mumbai Worksites Tobacco Control Study, a cluster randomized trial testing the effectiveness of an integrated tobacco control and occupational safety and health program in Indian manufacturing worksites. From June 2012 to June 2013, 20 companies were recruited. Companies were identified using association lists, referrals, internet searches and visits to industrial areas. Four hundred eighty companies were contacted to validate information, introduce the study and seek an in-person meeting with a company representative. Eighty-three company representatives agreed to meet. Of those 83 companies, 55 agreed to a formal 'pitch meeting' with key decision makers at the company. Seventy-seven recruitment 'pitches' were given, including multiple meetings in the same companies. If the company was interested, we obtained a letter of participation and employee roster. Based on this experience, recommendations are made that can help inform future researchers and practitioners wishing to recruit Indian worksites. When compared with recruitment of US manufacturing worksites, recruitment of Indian worksites lacked current industrial lists of companies to serve as a sampling frame, and required more in-person visits, incentives for control companies and more assurances around confidentiality to allow occupational safety and health experts into their worksite. PMID:25796269
New strategies to facilitate the improvement of physical and integrated biological optimization of high-precision treatment protocols are an important priority for modern radiation oncology. From a clinical perspective, as knowledge accumulates from molecular radiobiology, there is a complex and exciting opportunity to investigate novel approaches to rational patient treatment stratification based on actionable tumor targets, together with the appropriate design of next-generation early-phase radiotherapy trials utilizing targeted therapeutics, to formally evaluate relevant clinical and biomarker endpoints. A unique aspect in the development pathway of systemic agents with presumed radiosensitizing activity will also be the need for special attention on patient eligibility and the rigorous definition of radiation dose–volume relationships and potential dose-limiting toxicities. Based on recent experience from systematically investigating histone deacetylase inhibitors as radiosensitizing agents, from initial studies in preclinical tumor models through the conduct of a phase I clinical study to evaluate tumor activity of the targeted agent as well as patient safety and tumor response to the combined treatment modality, this communication will summarize principles relating to early clinical evaluation of combining radiotherapy and targeted therapeutics
Liu, Yen-Wan Hsueh; Chang, Chih-Ting; Yeh, Lan-Yun; Wang, Ling-Wei; Lin, Tzung-Yi
Under the collaboration between National Tsing Hua University and Taipei Veterans General Hospital, clinical trial of recurrent head-and-neck cancer by Boron neutron capture therapy at Tsing Hua open-pool reactor started on August 11, 2010. Up to January 2014, 17 patients were treated. Based on the treatment planning experiences of clinical trials using in-house designed THORplan, different setups should be used for superficial and deep-seated tumors. Superficial tumor treatment gains benefits from the use of patient collimator, while direct irradiation is a better choice for deep-seated tumor. PMID:26278349
Tong, Seng-Fah; Ng, Chirk-Jenn; Lee, Boon-Cheok; Lee, Verna-KM; Khoo, Ee-Ming; Lee, Eng-Giap; Tan, Hui-Meng
This study aimed to investigate the effect of intramuscular injection of testosterone undecanoate on overall quality of life (QoL) in men with testosterone deficiency syndrome (TDS). A randomized controlled trial over a 12-month period was carried out in 2009. One hundred and twenty men aged 40 years and above with a diagnosis of TDS (serum total testosterone
's correction and resubmission in 7 of 67 (10.4%) reviewed cases. Normal tissues required correction in 6 of 67 (8.9%) of cases. Initial field shaping differed from the submitted treatment plan by more than 5 mm in significant regions of the field in only 2% of the cases. Isocenter shifts of more than 5 mm on at least one of the treated fields was identified in 7% of initial port films examined. Dosimetry review has demonstrated that 14 of 86 cases (16.3%) had minor variations in target volume coverage (<100% of the target volume coverage by the prescription isodose) and 3.4% had major variation in dose coverage (<95% coverage of target volume by prescription isodose). Nineteen of 93 cases (20%) had more than 7% heterogeneity of dose within the planning target volume. CONCLUSION: 3DCRT can be studied and implemented in a cooperative group setting. Although data exchange problems in this study have been frequent, most of these problems occurred early in the trial and have been resolved in most circumstances. A significant amount of variation has been identified in the definition of target volumes and organs at risk. Similarly, field shaping and port film evaluation showed occasional errors. It is our impression that quality assurance is a critical component of 3DCRT in the cooperative group setting. As experience in the planning of patients with 3DCRT increases, it is expected that the frequency of planning variations will diminish
Full Text Available An extensive number of pathologies are associated with mitochondrial dysfunction (MDF and oxidative stress (OS. Thus, mitochondrial cofactors termed “mitochondrial nutrients” (MN, such as α-lipoic acid (ALA, Coenzyme Q10 (CoQ10, and l-carnitine (CARN (or its derivatives have been tested in a number of clinical trials, and this review is focused on the use of MN-based clinical trials. The papers reporting on MN-based clinical trials were retrieved in MedLine up to July 2014, and evaluated for the following endpoints: (a treated diseases; (b dosages, number of enrolled patients and duration of treatment; (c trial success for each MN or MN combinations as reported by authors. The reports satisfying the above endpoints included total numbers of trials and frequencies of randomized, controlled studies, i.e., 81 trials testing ALA, 107 reports testing CoQ10, and 74 reports testing CARN, while only 7 reports were retrieved testing double MN associations, while no report was found testing a triple MN combination. A total of 28 reports tested MN associations with “classical” antioxidants, such as antioxidant nutrients or drugs. Combinations of MN showed better outcomes than individual MN, suggesting forthcoming clinical studies. The criteria in study design and monitoring MN-based clinical trials are discussed.
Full Text Available Abstract Background The SINS trial (Controlled Clinical Trials ISRCTN48755084; Eudract No. 2004-004506-24 is a randomised controlled trial evaluating long term success of excisional surgery vs. imiquimod 5% cream for low risk nodular and superficial basal cell carcinoma (BCC. The trial included a discrete choice experiment questionnaire to explore patient preferences of a cream versus surgery for the treatment of their skin cancer. Methods The self-completed questionnaire was administered at baseline to 183 participants, measuring patients’ strength of preferences when choosing either alternative ‘surgery’ or ‘imiquimod cream’ instead of a fixed ‘current situation’ option (of surgical excision as standard practice in UK. The treatments were described according to: cost, chance of complete clearance, side effects and appearance. Participants had to choose between various scenarios. Analysis was performed using a mixed logit model, which took into account the impact of previous BCC treatment and sample preference variability. Results The analysis showed that respondents preferred ‘imiquimod cream’ to their ‘current situation’ or ‘surgery’, regardless of previous experience of BCC symptoms and treatment. Respondents were more likely to be worried about their cosmetic outcomes and side effects they might experience over and above their chance of clearance and cost. Those with no experience of surgery (compared with experience valued more the choice of ‘imiquimod cream’ (£1013 vs £781. All treatment characteristics were significant determinants of treatment choice, and there was significant variability in the population preferences for all of them. Conclusions Patients with BCC valued more ‘imiquimod cream’ than alternative ‘surgery’ options, and all treatment characteristics were important for their choice of care. Understanding how people with a BCC value alternative interventions may better inform the
Elliehausen, Gregory E.; Barbara R. Lowrey
The Truth in Savings Act mandates that financial institutions disclose certain information about the terms of consumer deposit accounts in specific forms and at specific times. Although many depository institutions provided disclosures of account terms before the act was passed in 1991, most did not satisfy completely all the requirements of the regulation (Regulation DD) adopted by the Federal Reserve Board to implement the law. Thus, the Truth in Savings law likely caused every depository i...
Jürgens, Rebecca; Grass, Annika; Drolet, Matthis; Fischer, Julia
Both in the performative arts and in emotion research, professional actors are assumed to be capable of delivering emotions comparable to spontaneous emotional expressions. This study examines the effects of acting training on vocal emotion depiction and recognition. We predicted that professional actors express emotions in a more realistic fashion than non-professional actors. However, professional acting training may lead to a particular speech pattern; this might account for vocal expressi...
Zainal, K. A.; Renwick, B.; Keyes, A.; Lose, A.; Kenyon, M.; DeJong, H; Broadbent, H.; Serpell, L; Richards, L.; Johnson-Sabine, E.; Boughton, N.; Whitehead, L.; Treasure, J; Schmidt, U.; MOSAIC trial group
BACKGROUND: This study is part of a series of process evaluations within the MOSAIC Trial (Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions). This randomised controlled trial (RCT) compared two psychological treatments, the Maudsley Model for Treatment of Adults with Anorexia Nervosa (MANTRA) and Specialist Supportive Clinical Management (SSCM) for adult outpatients with Anorexia Nervosa. The present process study integrates quantitative (treatment acceptabi...
Moodley Jothi; Maharaj Rashika; Guddera Vijayanand; Govinden Roshini; Gappoo Sharika; Ganesh Shay; Dladla-Qwabe Nozizwe; Coumi Nicola; Ramjee Gita; Morar Neetha; Naidoo Sarita; Palanee Thesla
Abstract Background South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council conducted four phase III and one phase IIb trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated, with HIV prevalence between 25% and 45% and HIV incidence ranging fr...
Kirkwood Betty R.; Pednekar Sulochana; Andrew Gracy; Pereira Bernadette; Patel Vikram
Abstract Background The MANAS trial reported that a Lay Health Counsellor (LHC) led collaborative stepped care intervention (the "MANAS intervention") for Common Mental Disorders (CMD) was effective in public sector primary care clinics but private sector General Practitioners (GPs) did as well with or without the additional counsellor. This paper aims to describe the experiences of integrating the MANAS intervention in primary care. Methods Qualitative semi-structured interviews with key mem...
Effects of natural childbirth preparation versus standard antenatal education on epidural rates, experience of childbirth and parental stress in mothers and fathers: a randomised controlled multicentre trial
Bergström, M; Kieler, H; Waldenström, U
Objective To examine the effects of antenatal education focussing on natural childbirth preparation with psychoprophylactic training versus standard antenatal education on the use of epidural analgesia, experience of childbirth and parental stress in first-time mothers and fathers. Design Randomised controlled multicentre trial. Setting Fifteen antenatal clinics in Sweden between January 2006 and May 2007. Sample A total of 1087 nulliparous women and 1064 of their partners. Methods Natural gr...
Nziguheba, G.; Tossah, B.K.; Diels, J.; Franke, A.C.; Aihou, K.; Iwuafor, E.N.O.; Nwoke, C.; Merckx, R.
Low soil fertility is one of the main constraints to crop production in the West African savanna. However, the response of major cereals to fertilizer applications is often far below the potential yields. Low fertilizer efficiency, inadequacy of current fertilizer recommendations, and the ignorance of nutrients other than N, P, and K may limit crop production. Nutrient limitations to maize production were identified in on-farm trials in Togo and in several long-term experiments in Nigeria and...
Developing and evaluating interventions to reduce inappropriate prescribing by general practitioners of antibiotics for upper respiratory tract infections: A randomised controlled trial to compare paper-based and web-based modelling experiments
Sullivan Frank; MacLennan Graeme; Pitts Nigel B; Bonetti Debbie; Eccles Martin; Francis Jillian; Ricketts Ian W; Treweek Shaun; Jones Claire; Weal Mark; Barnett Karen
Abstract Background Much implementation research is focused on full-scale trials with little evidence of preceding modelling work. The Medical Research Council Framework for developing and evaluating complex interventions has argued for more and better theoretical and exploratory work prior to a trial as a means of improving intervention development. Intervention modelling experiments (IMEs) are a way of exploring and refining an intervention before moving to a full-scale trial. They do this ...
Developing and evaluating interventions to reduce inappropriate prescribing by general practitioners of antibiotics for upper respiratory tract infections: a randomised controlled trial to compare paper-based and web-based modelling experiments
Treweek, S.; Ricketts, I. W.; Francis, J.; Eccles, M. P.; Bonetti, D.
Background: Much implementation research is focused on full-scale trials with little evidence of preceding modelling work. The Medical Research Council Framework for developing and evaluating complex interventions has argued for more and better theoretical and exploratory work prior to a trial as a means of improving intervention development. Intervention modelling experiments (IMEs) are a way of exploring and refining an intervention before moving to a full-scale trial. They do this by deliv...
Robinson, Mark; Geue, Claudia; Lewsey, James; MacKay, Daniel; McCartney, Gerry; Curnock, Esther; Beeston, Clare
Background and aims A ban on multi-buy discounts of off-trade alcohol was introduced as part of the Alcohol Act in Scotland in October 2011. The aim of this study was to assess the impact of this legislation on alcohol sales, which provide the best indicator of population consumption. Design Setting and Participants Interrupted time-series regression was used to assess the impact of the Alcohol Act on alcohol sales among off-trade retailers in Scotland. Models accounted for underlyi...
Sissons, Heather T.; Miller, Ralph R.
Three experiments were conducted to examine the interaction of overexpectation treatment and trial massing using a Pavlovian fear conditioning procedure with rats. In first-order conditioning, Experiment 1 found the overexpectation effect (i.e., decreased conditioned responding to a cue after compound training when the elements were previously reinforced), the trial spacing effect (i.e., decreased responding to a cue when reinforced trials are massed), and a counteraction between overexpectat...
Fu Dong-Jing; Ma Yi-Wen; Sliwa Jennifer K; Bossie Cynthia A; Alphs Larry
Abstract Background Paliperidone palmitate is a long-acting injectable atypical antipsychotic for the acute and maintenance treatment of adults with schizophrenia. The recommended initiation dosing regimen is 234 mg on Day 1 and 156 mg on Day 8 via intramuscular (deltoid) injection; followed by 39 to 234 mg once-monthly thereafter (deltoid or gluteal). These post-hoc analyses addressed two commonly encountered clinical issues regarding the initiation dosing: the time to onset of efficacy and ...
Full Text Available Hassan Adalatkhah,1 Homayoun Sadeghi-Bazargani2,3 1Department of Dermatology, Ardabil University of Medical Sciences, Ardabil, Iran; 2Road Traffic Injury Research Center, Department of Statistics and Epidemiology, Tabriz University of Medical Sciences, Tabriz, Iran; 3Department of Public Health Sciences, Karolinska Institute, Stockholm, Sweden Background: Treatment of melasma is unsatisfactory most of the times. Hormonal role is shown to exist in pathogenesis of the melasma, and sex-hormone related drugs may have an effect on melasma.Aim: To investigate efficacy of 1% flutamide cream versus 4% hydroquinone cream on melasma.Methods: In a parallel randomized clinical trial, 74 women with melasma were allocated to receive a sunscreen along with 4% hydroquinone cream or 1% flutamide cream. Melasma Area and Severity Index (MASI, mexameter melanin assay, and patient satisfaction were investigated.Results: Mean age of the participants was 33.8 years. Mean length of time suffering from Melasma was 96.3 months. The subjects reported in average 1.1 hours per day of exposure to sunlight. Mean standardized total patient satisfaction score was 28.8 (standard deviation [SD] 17.2 in flutamide group patients versus 18 (SD 15.5 in control group (P<0.01. Regardless of treatment group, the skin darkness assessed upon MASI scales was reduced over the treatment course (P<0.001. Using mixed effects, longitudinal modeling showed better treatment efficacy based on MASI scale for flutamide group compared to the hydroquinone group (P<0.05. However, longitudinal analysis of mexameter scores did not reveal any significant difference in melanin measurements between flutamide and hydroquinone.Conclusion: Topical flutamide appeared as effective as topical hydroquinone in treating melasma using mexameter assessment but with a better MASI improvement trend and higher patient satisfaction in flutamide treatment versus topical hydroquinone. As the present study is possibly the
Full Text Available Abstract Background Lack of physical activity (PA is a known risk factor for many health conditions. The workplace is a setting often used to promote activity and health. We investigated the effectiveness of an intervention on PA and productivity-related outcomes in an occupational setting. Methods We conducted a randomized controlled trial of 12 months duration with two 1:1 allocated parallel groups of insurance company employees. Eligibility criteria included permanent employment and absence of any condition that risked the participant’s health during PA. Subjects in the intervention group monitored their daily PA with an accelerometer, set goals, had access to an online service to help them track their activity levels, and received counseling via telephone or web messages for 12 months. The control group received the results of a fitness test and an information leaflet on PA at the beginning of the study. The intervention’s aim was to increase PA, improve work productivity, and decrease sickness absence. Primary outcomes were PA (measured as MET minutes per week, work productivity (quantity and quality of work; QQ index, and sickness absence (SA days at 12 months. Participants were assigned to groups using block randomization with a computer-generated scheme. The study was not blinded. Results There were 544 randomized participants, of which 521 were included in the analysis (64% female, mean age 43 years. At 12 months, there was no significant difference in physical activity levels between the intervention group (n = 264 and the control group (n = 257. The adjusted mean difference was −206 MET min/week [95% Bayesian credible interval −540 to 128; negative values favor control group]. There was also no significant difference in the QQ index (−0.5 [−4.4 to 3.3] or SA days (0.0 [−1.2 to 0.9]. Of secondary outcomes, body weight (0.5 kg [0.0 to 1.0] and percentage of body fat (0.6% [0.2% to 1.1%] were slightly
Nair, Manisha; Ariana, Proochista; Webster, Premila
Objective To explore the experiences of mothers employed through the Mahatma Gandhi National Rural Employment Guarantee Act (MGNREGA) using focus group discussions (FGDs) to understand the impact of mothers’ employment on infant feeding and care. The effects of mothers’ employment on nutritional status of children could be variable. It could lead to increased household income, but could also compromise child care and feeding. Setting The study was undertaken in the Dungarpur district of Rajas...
Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial
Full Text Available Abstract Background This post hoc analysis (trial registration: ClinicalTrials.gov NCT00590577 assessed onset of efficacy and tolerability of acute treatment with once-monthly paliperidone palmitate (PP, a long-acting atypical antipsychotic initiated by day 1 and day 8 injections, in a markedly to severely ill schizophrenia population. Methods Subjects entering the 13-week, double-blind trial were randomized to PP (39, 156, or 234 mg [25, 100, and 150 mg eq of paliperidone, respectively] or placebo. This subgroup analysis included those with a baseline Clinical Global Impressions-Severity (CGI-S score indicating marked to severe illness. PP subjects received a 234-mg day 1 injection (deltoid, followed by their assigned dose on day 8 and monthly thereafter (deltoid or gluteal. Thus, data for PP groups were pooled for days 4 and 8. Measures included Positive and Negative Syndrome Scale (PANSS, CGI-S, Personal and Social Performance (PSP, and adverse events (AEs. Analysis of covariance (ANCOVA and last-observation-carried-forward (LOCF methodologies, without multiplicity adjustments, were used to assess changes in continuous measures. Onset of efficacy was defined as the first time point a treatment group showed significant PANSS improvement (assessed days 4, 8, 22, 36, 64, and 92 versus placebo, which was maintained through end point. Results A total of 312 subjects met inclusion criterion for this subgroup analysis. After the day 1 injection, mean PANSS total scores improved significantly with PP (all received 234 mg versus placebo at day 4 (P = 0.012 and day 8 (P = 0.007. After the day 8 injection, a significant PANSS improvement persisted at all subsequent time points in the 234-mg group versus placebo (P P P P Conclusions In this markedly to severely ill population, acute treatment with 234 mg PP improved psychotic symptoms compared with placebo by day 4. After subsequent injections, observed improvements are suggestive of a dose
Full Text Available Abstract Background Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. Methods/Design A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age. Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. Discussion The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences
Phil Schumm; Theodore Karrison
In response to the 1997 Food and Drug Administration Modernization Act (FDAMA), the National Institutes of Health (NIH) established ClinicalTrials.gov, an online, publicly-accessible registry for clinical trials. The 2007 Food and Drug Administration Amendments Act (FDAAA) broadened the scope of eligible trials, added outcomes reporting as a requirement, and established penalties for non-compliance. Although ClinicalTrials.gov increased the transparency with which clinical trials are conducte...
Pinato, D J; Stavraka, C.; Tanner, M.; Esson, A.; Jacobson, E. W.; Wilkins, M. R.; Libri, V.
Background The detection of incidental findings (IF) in magnetic resonance imaging (MRI) studies is common and increases as a function of age. Responsible handling of IF is required, with implications for the conduct of research and the provision of good clinical care. Aim To investigate the prevalence and clinical significance of IF in a prospective cohort of healthy elderly volunteers who underwent MRI of the torso as a baseline investigation for a phase I trial. We assessed the ...
Santagostino, Elena; Martinowitz, Uri; Lissitchkov, Toshko; Pan-Petesch, Brigitte; Hanabusa, Hideji; Oldenburg, Johannes; Boggio, Lisa; Negrier, Claude; Pabinger, Ingrid; von Depka Prondzinski, Mario; Altisent, Carmen; Castaman, Giancarlo; Yamamoto, Koji; Álvarez-Roman, Maria-Teresa; Voigt, Christine; Blackman, Nicole; Jacobs, Iris
A global phase 3 study evaluated the pharmacokinetics, efficacy, and safety of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 63 previously treated male patients (12-61 years) with severe hemophilia B (factor IX [FIX] activity ≤2%). The study included 2 groups: group 1 patients received routine prophylaxis once every 7 days for 26 weeks, followed by either 7-, 10-, or 14-day prophylaxis regimen for a mean of 50, 38, or 51 weeks, respectively; group 2 patients received on-demand treatment of bleeding episodes for 26 weeks and then switched to a 7-day prophylaxis regimen for a mean of 45 weeks. The mean terminal half-life of rIX-FP was 102 hours, 4.3-fold longer than previous FIX treatment. Patients maintained a mean trough of 20 and 12 IU/dL FIX activity on prophylaxis with rIX-FP 40 IU/kg weekly and 75 IU/kg every 2 weeks, respectively. There was 100% reduction in median annualized spontaneous bleeding rate (AsBR) and 100% resolution of target joints when subjects switched from on-demand to prophylaxis treatment with rIX-FP (P< .0001). The median AsBR was 0.00 for all prophylaxis regimens. Overall, 98.6% of bleeding episodes were treated successfully, including 93.6% that were treated with a single injection. No patient developed an inhibitor, and no safety concerns were identified. These results indicate rIX-FP is safe and effective for preventing and treating bleeding episodes in patients with hemophilia B at dosing regimens of 40 IU/kg weekly and 75 IU/kg every 2 weeks. This trial was registered atwww.clinicaltrials.govas #NCT0101496274. PMID:26755710
Martinowitz, Uri; Lissitchkov, Toshko; Pan-Petesch, Brigitte; Hanabusa, Hideji; Oldenburg, Johannes; Boggio, Lisa; Negrier, Claude; Pabinger, Ingrid; von Depka Prondzinski, Mario; Altisent, Carmen; Castaman, Giancarlo; Yamamoto, Koji; Álvarez-Roman, Maria-Teresa; Voigt, Christine; Blackman, Nicole; Jacobs, Iris
A global phase 3 study evaluated the pharmacokinetics, efficacy, and safety of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 63 previously treated male patients (12-61 years) with severe hemophilia B (factor IX [FIX] activity ≤2%). The study included 2 groups: group 1 patients received routine prophylaxis once every 7 days for 26 weeks, followed by either 7-, 10-, or 14-day prophylaxis regimen for a mean of 50, 38, or 51 weeks, respectively; group 2 patients received on-demand treatment of bleeding episodes for 26 weeks and then switched to a 7-day prophylaxis regimen for a mean of 45 weeks. The mean terminal half-life of rIX-FP was 102 hours, 4.3-fold longer than previous FIX treatment. Patients maintained a mean trough of 20 and 12 IU/dL FIX activity on prophylaxis with rIX-FP 40 IU/kg weekly and 75 IU/kg every 2 weeks, respectively. There was 100% reduction in median annualized spontaneous bleeding rate (AsBR) and 100% resolution of target joints when subjects switched from on-demand to prophylaxis treatment with rIX-FP (P < .0001). The median AsBR was 0.00 for all prophylaxis regimens. Overall, 98.6% of bleeding episodes were treated successfully, including 93.6% that were treated with a single injection. No patient developed an inhibitor, and no safety concerns were identified. These results indicate rIX-FP is safe and effective for preventing and treating bleeding episodes in patients with hemophilia B at dosing regimens of 40 IU/kg weekly and 75 IU/kg every 2 weeks. This trial was registered at www.clinicaltrials.gov as #NCT0101496274. PMID:26755710
Field trials of pesticides are different from the general demonstration and simple effect observation They are the important workthat the country in order to ensure pesticide can control biological effect and be safe to crops and environment before pesticide entering the market. Field trials of pesticides need to evaluate their control effects, negative effects and environmental effects, and to provide data of registrations for pesticide enterprises and pesticide extension. As a result of efficacy trials of pesticide by natural conditions, the agricultural conditions, test the improper operation and other factorsled to the inaccuracy of the test data and the incomparability of prone. In order to ensure the accuracy and efficacy of pesticide trials, the experience and measures of field trials for pesticide were summed up based on many years of practicing experience.%农药田间药效试验有别于一般防治示范或简单的效果观察。它是农药在进入市场之前,国家为保证农药对有害生物的防治效果和对作物及环境的安全性而开展的一项重要工作。农药田间药效试验需要对农药产品防治效果、负面效应以及环境影响作出客观、公正的综合评价,为农药生产企业办理农药登记提供资料,为农药推广应用提供科学依据。为保证农药田间药效试验的准确性和对试验药剂进行客观合理的分析、评价,笔者通过多年的实践经历,总结了做好农药田间药效试验经验以及具体做法。
Hollman Frisman, Gunilla; Eriksson, Carrie; Pernehed, Sara; Mörelius, Evalotte
Aims and objectives. To explore and describe the experience of becoming a grandmother to a premature infant. Background. Becoming a grandmother involves a new perspective of life. Grandmothers of sick infants find themselves in a new situation with an adult child undergoing serious stress. Few studies have approached the grandmothers’ own experience of becoming a grandmother to a premature infant. Design. A qualitative content analysis was used. Methods. Eleven women, 52–66 years of age, ...
Delamou, Alexandre; Haba, Nyankoye Yves; Mari-Saez, Almudena; Gallian, Pierre; Ronse, Maya; Jacobs, Jan; Camara, Bienvenu Salim; Kadio, Kadio Jean-Jacques Olivier; Guemou, Achille; Kolie, Jean Pe; De Crop, Maaike; Chavarin, Patricia; Jacquot, Chantal; Lazaygues, Catherine; De Weggheleire, Anja; Lynen, Lutgarde; van Griensven, Johan
Although convalescent plasma (CP) transfusion was prioritized among potential Ebola treatments by the World Health Organization, there were concerns on the feasibility of its implementation. We report on the successful organization of donor mobilization and plasma collection as part of the Ebola-Tx clinical trial from November 2014 to July 2015 in Conakry, Guinea. Project implementation registers, tools and reports, mission reports, and minutes of research team meetings were used to reconstruct the sequence of events on how donor mobilization was organized, plasmapheresis was set up, and how effective this approach was in collecting CP. An initial needs assessment of the Guinean National Blood Transfusion Center resulted in targeted training of staff on site, resulting in autonomy and independent production of CP within 3 months. The Conakry Ebola Survivors Association played a direct role in donor mobilization and organization of CP donations. A total of 98 Ebola survivors were screened for plasma donation, of which 84 were found eligible for plasmapheresis. Of these, 26 (30.9%) were excluded. The remaining 58 donors made a total of 90 donations, corresponding to 50.9 L of CP. This sufficed to treat the 99 eligible patients enrolled in the trial. Within a poor resource emergency context, transfusion capacity could be rapidly improved through the strengthening of local capacities and gradual transfer of skills coupled with active involvement of Ebola survivors. However, large-scale plasma collection or multisite studies may require further adaptations of both strategy and logistics. The Ebola-Tx trial was funded by the European Union and others. PMID:27430546
Delamou, Alexandre; Haba, Nyankoye Yves; Mari-Saez, Almudena; Gallian, Pierre; Ronse, Maya; Jacobs, Jan; Camara, Bienvenu Salim; Kadio, Kadio Jean-Jacques Olivier; Guemou, Achille; Kolie, Jean Pe; Crop, Maaike De; Chavarin, Patricia; Jacquot, Chantal; Lazaygues, Catherine; Weggheleire, Anja De; Lynen, Lutgarde; van Griensven, Johan
Although convalescent plasma (CP) transfusion was prioritized among potential Ebola treatments by the World Health Organization, there were concerns on the feasibility of its implementation. We report on the successful organization of donor mobilization and plasma collection as part of the Ebola-Tx clinical trial from November 2014 to July 2015 in Conakry, Guinea. Project implementation registers, tools and reports, mission reports, and minutes of research team meetings were used to reconstruct the sequence of events on how donor mobilization was organized, plasmapheresis was set up, and how effective this approach was in collecting CP. An initial needs assessment of the Guinean National Blood Transfusion Center resulted in targeted training of staff on site, resulting in autonomy and independent production of CP within 3 months. The Conakry Ebola Survivors Association played a direct role in donor mobilization and organization of CP donations. A total of 98 Ebola survivors were screened for plasma donation, of which 84 were found eligible for plasmapheresis. Of these, 26 (30.9%) were excluded. The remaining 58 donors made a total of 90 donations, corresponding to 50.9 L of CP. This sufficed to treat the 99 eligible patients enrolled in the trial. Within a poor resource emergency context, transfusion capacity could be rapidly improved through the strengthening of local capacities and gradual transfer of skills coupled with active involvement of Ebola survivors. However, large-scale plasma collection or multisite studies may require further adaptations of both strategy and logistics. The Ebola-Tx trial was funded by the European Union and others. PMID:27430546
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. 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. 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. 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. NCT00953394
Mahapatra, Tanmay; Mahapatra, Sanchita; Pal, Debottam; Saha, Jayanta; Lopez, AnnaLena; Ali, Mohammad; Bannerjee, Barnali; Manna, Byomkesh; Sur, Dipika; Bhattacharya, Sujit; Kanungo, Suman
Experimental studies involving human subjects provide most internally valid evidences in epidemiological research due to their robust methodology. While conducting population-based interventional studies, to achieve external validity, inclusion of information from vulnerable groups like urban slum-dwellers of the developing world, in the epidemiological estimates is of paramount importance. The challenges faced while conducting 2 consecutive large-scale, community-based vaccine trials in urban slums of Kolkata, India are presented in this article. Interventions in these communities often get constrained by issues pertaining to human rights and benefits, socio-cultural factors, political environment, methodological shortcomings in addition to the challenges in ensuring community participation. While conducting these trials although we intermittently faced obstacles, by virtue of having a long term and robust surveillance system and developing a trusted relationship between the researchers, community leaders and residents we were able to come up with a commendable community participation which culminated into the success of the interventions. Bridging the gap between research and field operations by incorporating knowledge gathered from interventional studies and making strategies to improve health conditions of these informal settlers is a major unfulfilled agenda. We believe the lessons learnt during our research will help researchers while developing efficient interventions in similar setting. PMID:26224251
Prayle, A.P.; Hurley, M.N.; Smyth, Alan R
Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Design Registry based study of clinical trial summaries. Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one...
Snowdon Claire; Featherstone Katie; Ziebland Sue; Barker Karen; Frost Helen; Fairbank Jeremy
Abstract Background Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet relatively little qualitative work has explored clinicians' perceptions and understandings of trials. This study interviewed surgeons shortly after the multi-centre, pragm...
Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ...
Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... years of experiments in the laboratory and in animals before they even ... this early research occurs at universities and medical centers across the ...
Which treatment for low back pain? A factorial randomised controlled trial comparing intravenous analgesics with oral analgesics in the emergency department and a centrally acting muscle relaxant with placebo over three days [ISRCTN09719705
Full Text Available Abstract Background About two thirds of adults suffer from backpain at some time during their life. In the emergency room many patients with acute back pain are treated with intravenous non-steroidal analgesics. Whether this treatment is superior to oral administration of non-steroidal analgesics is unknown. Intravenous administration, however, requires considerable amounts of resources and accounts for high workload in busy clinics. In the further course centrally acting muscle relaxants are prescribed but the effectiveness remains unclear. The objective of this study is on the one hand to compare the effectiveness of intravenous with oral non-steroidal analgesics for acute treatment and on the other hand to compare the effectiveness of a centrally active muscle relaxant with placebo given for three days after presentation to the ED (emergency department. Methods/Design This study is intended as a randomised controlled factorial trial mainly for two reasons: (1 the sequence of treatments resembles the actual proceedings in every-day clinical practice, which is important for the generalisability of the results and (2 this design allows to take interactions between the two sequential treatment strategies into account. There is a patient preference arm included because patients preference is an important issue providing valuable information: (1 it allows to assess the interaction between desired treatment and outcome, (2 results can be extrapolated to a wider group while (3 conserving the advantages of a fully randomised controlled trial. Conclusion We hope to shed more light on the effectiveness of treatment modalities available for acute low back pain.
Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial
Background This post hoc analysis (trial registration: ClinicalTrials.gov NCT00590577) assessed onset of efficacy and tolerability of acute treatment with once-monthly paliperidone palmitate (PP), a long-acting atypical antipsychotic initiated by day 1 and day 8 injections, in a markedly to severely ill schizophrenia population. Methods Subjects entering the 13-week, double-blind trial were randomized to PP (39, 156, or 234 mg [25, 100, and 150 mg eq of paliperidone, respectively]) or placebo. This subgroup analysis included those with a baseline Clinical Global Impressions-Severity (CGI-S) score indicating marked to severe illness. PP subjects received a 234-mg day 1 injection (deltoid), followed by their assigned dose on day 8 and monthly thereafter (deltoid or gluteal). Thus, data for PP groups were pooled for days 4 and 8. Measures included Positive and Negative Syndrome Scale (PANSS), CGI-S, Personal and Social Performance (PSP), and adverse events (AEs). Analysis of covariance (ANCOVA) and last-observation-carried-forward (LOCF) methodologies, without multiplicity adjustments, were used to assess changes in continuous measures. Onset of efficacy was defined as the first time point a treatment group showed significant PANSS improvement (assessed days 4, 8, 22, 36, 64, and 92) versus placebo, which was maintained through end point. Results A total of 312 subjects met inclusion criterion for this subgroup analysis. After the day 1 injection, mean PANSS total scores improved significantly with PP (all received 234 mg) versus placebo at day 4 (P = 0.012) and day 8 (P = 0.007). After the day 8 injection, a significant PANSS improvement persisted at all subsequent time points in the 234-mg group versus placebo (P < 0.05). PANSS improvements were greater from day 36 through end point in the 156-mg group (P < 0.05) and only at end point in the 39-mg group (P < 0.05). CGI-S and PSP scores improved significantly in the 234-mg and 156-mg PP groups versus placebo at end
Rashid-Doubell, F; Mohamed, S; Elmusharaf, K; O'Neill, C S
Objective The aims of this study were to describe the experiences of senior students using mobile devices in a clinical setting while learning and interacting with clinical teachers, patients and each other, and to identify challenges that facilitated or impeded the use of such devices in the hospital. Design Interpretative phenomenology was chosen to guide our enquiry. Semi-structured interviews were conducted to examine the experiences of five senior medical students using mobile devices in the clinical setting. Setting and participants Senior medical students at an international medical school in the Middle East. Results Three main themes emerged from the data analysis: learning; professional identity and transitioning from student to doctor. The findings showed that using mobile devices in the clinical area as a learning tool was not a formalised process. Rather, it was opportunistic learning at the bedside and on occasion a source of distraction from clinical teaching. Students needed to negotiate relationships between themselves, the clinical teacher and patients in order to ensure that they maintained an acceptable professional image. Participants experienced and negotiated the change from student to doctor making them mindful of using their devices at the bedside. Conclusions Mobile devices are part of daily life for a medical student and there is a need to adapt medical education in the clinical setting, to allow the students to use their devices in a sensitive manner. PMID:27142860
Full Text Available ... radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory and in animals ... term side effects. This phase can last several years. A Phase III trial gathers more information about ...
Farmer Andrew J
align it with their clinical practices and experiences. Conclusions To understand trial findings, foster attainment of endpoints, and promote protocol fidelity, it may be necessary to look beyond individual patient characteristics and experiences. Specifically, the context of trial delivery, the impact of staff involvement, and the difficulties staff may encounter in balancing competing 'clinical' and 'research' roles and responsibilities may need to be considered and addressed.
Harries, Anthony D; Ford, Nathan; Jahn, Andreas; Schouten, Erik J; Libamba, Edwin; Chimbwandira, Frank; Maher, Dermot
The scale-up of antiretroviral therapy (ART) in Malawi was based on a public health approach adapted to its resource-poor setting, with principles and practices borrowed from the successful tuberculosis control framework. From 2004 to 2015, the number of new patients started on ART increased from about 3000 to over 820,000. Despite being a small country, Malawi has made a significant contribution to the 15 million people globally on ART and has also contributed policy and service delivery innovations that have supported international guidelines and scale up in other countries. The first set of global guidelines for scaling up ART released by the World Health Organization (WHO) in 2002 focused on providing clinical guidance. In Malawi, the ART guidelines adopted from the outset a more operational and programmatic approach with recommendations on health systems and services that were needed to deliver HIV treatment to affected populations. Seven years after the start of national scale-up, Malawi launched a new strategy offering all HIV-infected pregnant women lifelong ART regardless of the CD4-cell count, named Option B+. This strategy was subsequently incorporated into a WHO programmatic guide in 2012 and WHO ART guidelines in 2013, and has since then been adopted by the majority of countries worldwide. In conclusion, the Malawi experience of ART scale-up has become a blueprint for a public health response to HIV and has informed international efforts to end the AIDS epidemic by 2030. PMID:27600800
To introduce our experience of treating locally and regionally recurrent head and neck cancer patients with BNCT at Tsing Hua Open-Pool Reactor in Taiwan, 12 patients (M/F=10/2, median age 55.5 Y/O) were enrolled and 11 received two fractions of treatment. Fractionated BNCT at 30-day interval with adaptive planning according to changed T/N ratios was feasible, effective and safe for selected recurrent head and neck cancer in this trial. - Highlights: • We treated 12 patients with recurrent Head and Neck (H and N) cancer after radical surgery and radiotherapy since 2010. • Four complete response (CR) and 3 partial response (PR) were found. Total response rate was 58%. • Two patients had local control longer than one year. • No grade 4 or higher toxicity was noted for both acute and chronic effects
At the Rossendorf location persons from external companies and institutions are acting in the scope of the decommissioning of the nuclear facilities. In addition to an individual monitoring in radiation protection an instruction is required for those persons before starting the work. The aim of this instruction is to give among important directives the actual facts about the location an their facilities. A system with particular selecting components seems to be the best solution with regard to effectiveness and available knowledge. The instruction takes place with a computer-added multimedia presentation. In the present paper should be presented in a short view the contents of the components and first experiences in handling this instruction. (orig.)
Full Text Available Abstract Background Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet relatively little qualitative work has explored clinicians' perceptions and understandings of trials. This study interviewed surgeons shortly after the multi-centre, pragmatic RCT in which they had participated had been completed. Methods We used in-depth interviews with surgeons who participated in the Spine Stabilisation Trial (a pragmatic RCT to explore their understanding of the trial purpose and how this understanding had influenced their recruitment procedures and interpretation of the results. A purposive sample of eleven participating surgeons was chosen from 8 of the 15 UK trial centres. Results Although the surgeons thought that the trial was addressing an important question there was little agreement about what this question was: although it was a trial of 'equivalent' treatments, some thought that it was a trial of surgery, others a trial of rehabilitation and others that it was exploring what to do with patients in whom all other treatment options had been unsuccessful. The surgeons we interviewed were not aware of the rationale for the pragmatic inclusion criteria and nearly all were completely baffled about the meaning of 'equipoise'. Misunderstandings about the entry criteria were an important source of confusion about the results and led to reluctance to apply the results to their own practice. Conclusion The study suggests several lessons for the conduct of future multi-centre trials. Recruiting surgeons (and other clinicians may not be familiar with the rationale for pragmatic designs and may need to be regularly reminded about the purpose during the study. Reassurance may be necessary that a pragmatic
Dufka, Faustine L.; Munch, Troels; Dworkin, Robert H.; Rowbotham, Michael C.
Abstract Evidence-based medicine rests on the assumption that treatment recommendations are robust, free from bias, and include results of all randomized clinical trials. The Repository of Registered Analgesic Clinical Trials search and analysis methodology was applied to create databases of complex regional pain syndrome (CRPS) and central post-stroke pain (CPSP) trials and adapted to create the Repository of Registered Analgesic Device Studies databases for trials of spinal cord stimulation (SCS), repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (tDCS). We identified 34 CRPS trials, 18 CPSP trials, 72 trials of SCS, and 92 trials of rTMS/tDCS. Irrespective of time since study completion, 45% of eligible CRPS and CPSP trials and 46% of eligible SCS and rTMS/tDCS trials had available results (peer-reviewed literature, results entered on registry, or gray literature); peer-reviewed publications could be found for 38% and 39%, respectively. Examining almost 1000 trials across a spectrum of painful disorders (fibromyalgia, diabetic painful neuropathy, post-herpetic neuralgia, migraine, CRPS, CPSP) and types of treatment, no single study characteristic consistently predicts unavailability of results. Results availability is higher 12 months after study completion but remains below 60% for peer-reviewed publications. Recommendations to increase results availability include supporting organizations advocating for transparency, enforcing existing results reporting regulations, enabling all primary registries to post results, stating trial registration numbers in all publication abstracts, and reducing barriers to publishing “negative” trials. For all diseases and treatment modalities, evidence-based medicine must rigorously adjust for the sheer magnitude of missing results in formulating treatment recommendations. PMID:25599303
Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...
... ACT. It is important to evaluate how the person is responding to this ACT lower limit and to the amount of heparin ... to determine someone's heparin anticoagulant requirements, stabilize the person, and then change the monitoring tool. The ACT may be influenced by a person's platelet count ...
PURPOSE: To gain experience in measuring quality of life (QOL) using the FACT-L in patients (pt) with non small cell lung cancer (NSCLC) treated with an altered fractionation regimen, HART, in a Phase II, multiinstitutional ECOG trial. MATERIALS AND METHODS: Version 2 of FACT-L, with 43 questions in 6 subscale categories (8 physical well-being, 8 social/family well-being, 3 relationship with doctor, 6 emotional well-being, 8 functional well-being, 10 lung cancer symptoms), available in English, Spanish and French, was administered by data managers and filled out by pts, independent of physician presence or input. The HART trial enrolled 30 pts, and FACT-L was administered at baseline (tp 1), treatment completion (tp 2) and 4 weeks following therapy (tp 3). (35(43)) FACT-L items were designed to yield a total QOL score with higher values reflective of better QOL; in addition, a FACT-L trial outcome index (TOI) was computed (TOI = physical score + functional score + lung cancer related score), and is considered the most relevant clinical QOL measure. RESULTS: The FACT-L completion rates were: tp 1 - (30(30)) (100%), tp 2 - (29(30)) (97%) and tp 3 - (24(30)) (80%); the mean scores at various time points are summarized in the table below and indicate that FACT-L is responsive to changes over time. The differences in subscales and total scores can be used as a measure of change in QOL resulting from treatment; statistically significant change was noted from baseline to tp 2 for physical, emotional and functional well-being; and from baseline to tp 3 for emotional well-being. The change in TOI score was also evaluated as a function of response and toxicity grade, and no clear association emerged. When assessed as a function of survival (at the time of this analysis, (5(30)) pt were alive, with median survival of 56 weeks), the degradation in QOL was most severe for pt who died early; the mean change in TOI from baseline to tp 3 for pt dying in the first 25 weeks, 25
Lukach, Alexis J; Jedrziewski, M Kathryn; Grove, George A; Mechanic-Hamilton, Dawn J; Williams, Shardae S; Wollam, Mariegold E; Erickson, Kirk I
The Rhythm Experience and Africana Culture Trial (REACT!) is a multi-site randomized controlled intervention study designed to examine the efficacy of using African Dance as a form of moderate-intensity physical activity to improve cognitive function in older African Americans. African Americans are almost two times more likely than Caucasians to experience cognitive impairment in late adulthood. This increased risk may be attributed to lower level and quality of education, lower socioeconomic status, and higher prevalence of vascular diseases, type 2 diabetes, hypertension, and obesity, all of which are recognized as risk factors for dementia. Fortunately, interventions targeting cardiovascular health (i.e., physical activity) are associated with improved neurocognitive function and a reduced risk for dementia, so African Americans may be particularly suited for interventions targeting cardiovascular health and cognitive function. Here, we describe a randomized intervention protocol for increasing physical activity in older (65-75years) African Americans. Participants (n=80) at two study locations will be randomized into one of two groups. The treatment group will participate in African Dance three times per week for six months and the control group will receive educational training on Africana history and culture, as well as information about health behaviors, three times per week for six months. If successful, the REACT! study may transform community interventions and serve as a platform and model for testing other populations, age groups, and health outcomes, potentially identifying novel and creative methods for reducing or eliminating health disparities. PMID:27033674
Brewington, John J; McPhail, Gary L; Clancy, John P
Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator protein (CFTR), leading to significant morbidity and mortality. CFTR is a chloride and bicarbonate channel at the epithelial cell membrane. The most common CFTR mutation is F508del, resulting in minimal CFTR at the plasma membrane. Current disease management is supportive, whereas an ultimate goal is to develop therapies to restore CFTR activity. We summarize experience with lumacaftor, a small molecule that increases F508del-CFTR levels at the plasma membrane. Lumacaftor in combination with ivacaftor, a modulator of CFTR gating defects, improves clinical outcome measures in patients homozygous for the F508del mutation. Lumacaftor represents a significant advancement in the treatment of biochemical abnormalities in CF. Further development of CFTR modulators will improve upon current therapies, although it remains unclear whether this approach will provide therapies for all CFTR mutations. PMID:26581802
Full Text Available A scheme for monitoring icing on overhead transmission lines with fiber Bragg grating (FBG strain sensors is designed and evaluated both theoretically and experimentally. The influences of temperature and wind are considered. The results of field experiments using simulated ice loading on windless days indicate that the scheme is capable of monitoring the icing thickness within 0–30 mm with an accuracy of ±1 mm, a load cell error of 0.0308v, a repeatability error of 0.3328v and a hysteresis error is 0.026%. To improve the measurement during windy weather, a correction factor is added to the effective gravity acceleration, and the absolute FBG strain is replaced by its statistical average.
Co-curator of ACTS 2014 together with Rasmus Holmboe, Judith Schwarzbart and Sanne Kofoed. ACTS is the Museum of Contemporary Art’s international bi-annual festival. ACTS was established in 2011 and, while the primary focus is on sound and performance art, it also looks toward socially oriented art....... For the 2014 festival, the museum has entered into a collaboration with the Department for Performance Design at Roskilde University – with continued focus on sound and performance art, and social art in public spaces. With ACTS, art moves out of its usual exhibition space and instead utilizes the...... city, its various possibilities and public spaces as a stage. ACTS takes place in and around the museum and diverse locations in Roskilde city. ACTS is partly curated by the museum staff and partly by guest curators. ACTS 2014 is supported by Nordea-fonden and is a part of the project The Museum goes...
Resende, Nathália Maria; de Magalhães Neto, Anibal Monteiro; Bachini, Flávio; de Castro, Luis Eduardo Viveiros; Bassini, Adriana; Cameron, L C
Physical exercise affects hematological equilibrium and metabolism. This study evaluated the biochemical and hematological responses of a male world-class athlete in sailing who is ranked among the top athletes on the official ISAF ranking list of windsurfing, class RS:X. The results describe the metabolic adaptations of this athlete in response to exercise in two training situations: the first when the athlete was using the usual training and dietary protocol, and the second following training and nutritional interventions based on a careful analysis of his diet and metabolic changes measured in a simulated competition. The intervention protocol for this study consisted of a 3-month facility-based program using neuromuscular training (NT), aerobic training (AT), and nutritional changes to promote anabolism and correct micronutrient malnutrition. Nutritional and training intervention produced an increase in the plasma availability of branched-chain amino acids (BCAAs), aromatic amino acids (AAAs), alanine, glutamate, and glutamine during exercise. Both training and nutritional interventions reduced ammonemia, uricemia, and uremia. In addition, we are able to correct a significant drop in potassium levels during races by correct supplementation. Due to the uniqueness of this experiment, these results may not apply to other windsurfers, but we nonetheless had the opportunity to characterize the metabolic adaptations of this athlete. We also proposed the importance of in-field metabolic analyses to the understanding, support, and training of world-class elite athletes. PMID:21978397
Bellavista, Paolo; Corradi, Antonio; Foschini, Luca; Ianniello, Raffaele
Nowadays, sensor-rich smartphones potentially enable the harvesting of huge amounts of valuable sensing data in urban environments, by opportunistically involving citizens to play the role of mobile virtual sensors to cover Smart City areas of interest. This paper proposes an in-depth study of the challenging technical issues related to the efficient assignment of Mobile Crowd Sensing (MCS) data collection tasks to volunteers in a crowdsensing campaign. In particular, the paper originally describes how to increase the effectiveness of the proposed sensing campaigns through the inclusion of several new facilities, including accurate participant selection algorithms able to profile and predict user mobility patterns, gaming techniques, and timely geo-notification. The reported results show the feasibility of exploiting profiling trends/prediction techniques from volunteers' behavior; moreover, they quantitatively compare different MCS task assignment strategies based on large-scale and real MCS data campaigns run in the ParticipAct living lab, an ongoing MCS real-world experiment that involved more than 170 students of the University of Bologna for more than one year. PMID:26263985
Desmond, Brian S; Laux, Molly A; Levin, Carolyn C; Huang, Jiaxin; Williams, Brent C
Since the enactment of the Affordable Care Act (ACA), many people remain uninsured. While studies have examined this population, few have explored patients' experiences seeking insurance. To elucidate these individuals' perspectives, we surveyed patients (n = 80) at the University of Michigan Student-Run Free Clinic concerning their activity accessing insurance. Over half of respondents had sought insurance in the past 6 months; 57 % of respondents qualified for Medicaid by self-reported income (≤138 % FPL) and all but one were eligible for tax credits on the Health Insurance Marketplace. However, only 35 % of apparently Medicaid-eligible respondents had recently applied. There was no significant difference in the rate of applying for those above the income cutoff (p = 0.901). Perceived expense of plans and belief of ineligibility for Medicaid discouraged respondents from actively seeking insurance. Personalized outreach emphasizing new Medicaid eligibility requirements and tax credits may be needed to facilitate Medicaid enrollment for some uninsured persons under the ACA. PMID:26512012
Full Text Available Nowadays, sensor-rich smartphones potentially enable the harvesting of huge amounts of valuable sensing data in urban environments, by opportunistically involving citizens to play the role of mobile virtual sensors to cover Smart City areas of interest. This paper proposes an in-depth study of the challenging technical issues related to the efficient assignment of Mobile Crowd Sensing (MCS data collection tasks to volunteers in a crowdsensing campaign. In particular, the paper originally describes how to increase the effectiveness of the proposed sensing campaigns through the inclusion of several new facilities, including accurate participant selection algorithms able to profile and predict user mobility patterns, gaming techniques, and timely geo-notification. The reported results show the feasibility of exploiting profiling trends/prediction techniques from volunteers’ behavior; moreover, they quantitatively compare different MCS task assignment strategies based on large-scale and real MCS data campaigns run in the ParticipAct living lab, an ongoing MCS real-world experiment that involved more than 170 students of the University of Bologna for more than one year.
Masiello, C. A.; Gao, X.; Dugan, B.; Silberg, J. J.; Zygourakis, K.; Alvarez, P. J. J.
The biochar community is excellent at pointing to individual cases where biochar amendment has changed soil properties, with some studies showing significant improvements in crop yields, reduction in nutrient export, and remediation of pollutants. However, many studies exist which do not show improvements, and in some cases, studies clearly show detrimental outcomes. The next, crucial step in biochar science and engineering research will be to develop a process-based understanding of how biochar acts to improve soil properties. In particular, we need a better mechanistic understanding of how biochar sorbs and desorbs contaminants, how it interacts with soil water, and how it interacts with the soil microbial community. These mechanistic studies need to encompass processes that range from the nanometer to the kilometer scale. At the nanometer scale, we need a predictive model of how biochar will sorb and desorb hydrocarbons, nutrients, and toxic metals. At the micrometer scale we need models that explain biochar's effects on soil water, especially the plant-available fraction of soil water. The micrometer scale is also where mechanistic information is neeed about microbial processes. At the macroscale we need physical models to describe the landscape mobility of biochar, because biochar that washes away from fields can no longer provide crop benefits. To be most informative, biochar research should occur along a lab-greenhouse-field trial trajectory. Laboratory experiments should aim determine what mechanisms may act to control biochar-soil processes, and then greenhouse experiments can be used to test the significance of lab-derived mechanisms in short, highly replicated, controlled experiments. Once evidence of effect is determined from greenhouse experiments, field trials are merited. Field trials are the gold standard needed prior to full deployment, but results from field trials cannot be extrapolated to other field sites without the mechanistic backup provided
Milton G. Fuzatto
Full Text Available Neste artigo são relatados os resultados de 12 ensaios, instalados em vários tipos de solo do Estado de São Paulo, para comparar o efeito de diferentes adubos azotados na cultura algodoeira. Salitre do Chile, nitrato de cal IG e Calnitro IG, aplicados no sulco de plantio juntamente com fósforo e potássio, não diferiram substancialmente. Apenas Urecal IG se mostrou menos eficiente. Aplicados em cobertura aos 30 dias após a germinação, o salitre do Chile, sulfato dc amônio e Nitrocálcio tiveram comportamento semelhante, mas a uréia se mostrou levemente inferior.In this paper are reported the results obtained in twelve experiments comparing various nitrogen sources as mineral fertilizers for cotton. Experiments were conducted for some years, located at different soil types used for cotton in the State of São Paulo. When applying Chilean nitrate, Calnitro IG. nitrato de cal IG and Urecal IG in the furrows together with phosphorus and potassium, the effects obtained were practically the same, except for Urecal IG which showed minor response. With exception of Chilean nitrate, these fertilisers are no more used by farmers presently. In another series of trials Chilean nitrate, ammonium sulphate, Nitrocalcio (ammonium nitrate + calcium carbonate and urea were applied as dressing after 30 days of planting time. These treatments had about the same results; however treatment with urea had a lower effect.
Kirkwood Betty R
Full Text Available Abstract Background The MANAS trial reported that a Lay Health Counsellor (LHC led collaborative stepped care intervention (the "MANAS intervention" for Common Mental Disorders (CMD was effective in public sector primary care clinics but private sector General Practitioners (GPs did as well with or without the additional counsellor. This paper aims to describe the experiences of integrating the MANAS intervention in primary care. Methods Qualitative semi-structured interviews with key members (n = 119 of the primary health care teams upon completion of the trial and additional interviews with control arm GPs upon completion of the outcome analyses which revealed non-inferiority of this arm. Results Several components of the MANAS intervention were reported to have been critically important for facilitating integration, notably: screening and the categorization of the severity of CMD; provision of psychosocial treatments and adherence management; and the support of the visiting psychiatrist. Non-adherence was common, often because symptoms had been controlled or because of doubt that health care interventions could address one's 'life difficulties'. Interpersonal therapy was intended to be provided face to face by the LHC; however it could not be delivered for most eligible patients due to the cost implications related to travel to the clinic and the time lost from work. The LHCs had particular difficulty in working with patients with extreme social difficulties or alcohol related problems, and elderly patients, as the intervention seemed unable to address their specific needs. The control arm GPs adopted practices similar to the principles of the MANAS intervention; GPs routinely diagnosed CMD and provided psychoeducation, advice on life style changes and problem solving, prescribed antidepressants, and referred to specialists as appropriate. Conclusion The key factors which enhance the acceptability and integration of a LHC in primary care are
Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B
This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...
Hermano Vaz de Arruda
Full Text Available No presente trabalho é apresentado um método de pesquisar a necessidade de fileiras de bordaduras, num ensaio de variedades de feijão. O método baseou-se na concordância das análises parciais (fileiras úteis e fileiras de bordaduras com a análise do total (úteis mais bordaduras, verificada através dos valores de F e dos coeficientes de variação. A concordância das três análises, para os citados valores, indica uma correlação entre as produções das fileiras centrais e de bordaduras e, portanto, a dispensa destas últimas. Como complemento da análise anterior aplicou-se a análise da covariância, considerando x a produção das fileiras de bordadura e y a das fileiras centrais. Com base nesta análise calcularam-se os coeficientes de correlação entre as médias das variedades e dentro das variedades. Ambos foram altamente significativos, indicando alta correlação entre as produções parciais (fileiras úteis e de bordaduras, já deduzidas pela primeira análise. Conclui-se que o uso das fileiras de bordaduras em experiências de campo, principalmente nas de competição de variedades, só deve ser feito quando houver qualquer razão para se suspeitar da concorrência entre as linhas adjacentes dos diversos canteiros. Quando forem incluídas as fileiras de bordaduras, estas devem ser também colhidas para r em confronto com as fileiras internas ou úteis, decidir-se pela continuação de tal técnica experimental.A been variety trial was used by the author to investigate the problem as to whether or not it is necessary to use guard rows for this type of experiments. The inner rows and the guard rows of each plot of the experiment, were harvested separately and statistical analysis was carried out on their separate yields and also on that of the plot as a whole. A satisfactory agreement was found between the F values and the coefficients of variation for the inner rows, for the guard rows, and for the whole plot. An F
Lappalainen, Päivi; Granlund, Anna; Siltanen, Sari; Ahonen, Suvi; Vitikainen, Minna; Tolvanen, Asko; Lappalainen, Raimo
The aim of the present study was to investigate two interventions based on Acceptance and Commitment Therapy (ACT) for depressive symptoms: A face-to-face treatment (ACT group) was compared to a guided self-help treatment delivered via the Internet consisting of two assessment sessions (pre and post) and an ACT-based Internet program (iACT). Outpatients experiencing at least mild depressive symptoms were randomized to either approach. The iACT treatment group received access to an ACT-based Internet program and supportive web-based contact over a period of 6 weeks. The face-to-face group received ACT-based treatment once a week over the same period of time. In both groups, the results showed a significant effect on depression symptomatology, and general wellbeing after treatment and at the 18-month follow-up. However, the data indicated that the iACT group changed differently regarding depressive symptoms and wellbeing as compared to the face-to face ACT group. Results showed large pre-treatment to 18-month follow-up within-group effect sizes for all symptom measures in the iACT treatment group (1.59-2.08), and for most outcome measures in the face-to-face ACT group (1.12-1.37). This non-inferiority study provides evidence that guided Internet-delivered ACT intervention can be as effective as ACT-based face-to-face treatment for outpatients reporting depressive symptoms, and it may offer some advantages over a face-to-face intervention. PMID:25127179
The potential market for irradiated chicken breasts was investigated using a mail survey and a retail trial. Results from the mail survey suggested a significantly higher level of acceptability of irradiated chicken than did the retail trial. A subsequent market experiment involving actual purchases showed levels of acceptability similar to that of the mail survey when similar information about food irradiation was provided
Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Rinke de Wit, Tobias F.
Background Health worker density per 1000 population in Ghana is one of the lowest in the world estimated to be 2.3, below the global average of 9.3. Low health worker motivation induced by poor working conditions partly explain this challenge. Albeit the wage bill for public sector health workers is about 90% of domestic government expenditure on health in countries such as Ghana, staff motivation and performance output remain a challenge, suggesting the need to complement financial incentives with non-financial incentives through a community-based approach. In this study, a systematic community engagement (SCE) intervention was implemented to engage community groups in healthcare quality assessment to promote mutual collaboration between clients and healthcare providers, and enhance health worker motivation levels. SCE involves structured use of existing community groups and associations to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements made and rewards given to best performing facilities for closing quality care gaps. Purpose To evaluate the effect of SCE interventions on health worker motivation and experiences with clients. Methods The study is a cluster randomized trial involving health workers in private (n = 38) and public (n = 26) primary healthcare facilities in two administrative regions in Ghana. Out of 324 clinical and non-clinical staff randomly interviewed at baseline, 234 (72%) were successfully followed at end-line and interviewed on workplace motivation factors and personal experiences with clients. Propensity score matching and difference-in-difference estimations were used to estimate treatment effect of the interventions on staff motivation. Results Intrinsic (non-financial) work incentives including cordiality with clients and perceived career prospects appeared to be prime sources of motivation for health staff interviewed in intervention health facilities while
G. P. Viégas
Full Text Available No presente estudo são apresentados os resultados obtidos em dez ensaios - três dos quais repetidos, nos mesmos canteiros, por cinco, sete ou oito anos - visando investigar o efeito da torta de algodão empregada isoladamente ou em combinação com cinzas de café e farinha de ossos. Êsses ensaios foram realizados entre 1943-44 e 1951-52 e localizados em sete diferentes estações experimentais do Estado de São Paulo : Campinas, Capão Bonito, Jaú, Pindamonhangaba, Ribeirão Prêto, Santa Rita do Passa-Quatro e Sorocaba. Enquanto a farinha de ossos só aumentou significativamente a produção em Santa Rita, e as cinzas de café, em Santa Rita e Ribeirão Prêto, a torta de algodão provocou aumentos significativos em Santa Rita (dois ensaios, Ribeirão Prêto, Jaú e Campinas Nem sempre a torta deu os resultados esperados, para isso concorrendo, conforme o caso, a elevada fertilidade de algumas terras, o tempo e outros fatores desfavoráveis. Umfator, que em muitos casos contribuiu para diminuir o efeito da torta, foi a redução por ela causada no "stand". Na dose de 500 kg/ha, e completada com outros adubos, onde necessário, a torta de algodão mostrou ser ótima fonte de nutrientes para o milho, mas seu efeito é muito variável quando a aplicação é feita nos sulcos de plantio e no momento em que este é efetuado.In this paper are reported the results obtained in ten fertilizer experiments three of which repeated in the same plots during five, seven or eight seasons - to study the effect, on the corn crop, of cottonseed meal used alone or combined with bone meal or coffee bean ash. These trials were conducted between 1943-44 and 1951-52 and located at seven different agricultural experiment stations of the State of São Paulo. As a whole, the study indicates that, at the rate of about 500 kilograms to the hectare and supplemented where needed with other fertilizers, cottonseed meal is a good source of nutrients for corn, but results
Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko [Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment] [and others
The sea trial of the first Japan nuclear Ship `MUTSU` was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).
Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko (Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment) (and others)
The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).
The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author)
Full Text Available Neste trabalho são relatados os resultados de quatro experiências de adubação do algodoeiro em terra-roxa, realizadas nos municípios de Araras, Avaré, Limeira e São Carlos. Tôdas foram instaladas em 1942-43. sendo que a de Araras foi conduzida por quatro anos nos mesmos canteiros. Em esquema fatorial 2x4x3, com seis repetições, foram comparados os níveis 0 e 15 kg/ha de N (salitre do Chile; 0, 30, 60 e 90 kg/ha de P2O5 (superfosfato simples; 0, 25 e 50 kg. ha de K2O (cloreto de potássio. Somente na experiência de Limeira, em solo repetidamente adubado com fósforo nas culturas anteriores, é que as respostas ao nitrogênio e ao potássio foram satisfatórias. Para a pequena reação a êsses elementos nas outras localidades parece terem concorrido a pobreza dos solos em fósforo e o método de aplicação dos adubos: nos sulcos de plantio, ao ser êste efetuado. Em contraste, o efeito principal do fósforo, que foi de apenas + 13% em Limeira, ultrapassou +30% nas demais experiências. As respostas às doses de 30, 60 e 90 kg/ha de P2O5, corresponderam, respectivamente, a +62, +85 e +96% em Araras (médias dos quatro anos, +36, +39 e +48% em São Carlos. +36, +34 e +42% em Avaré e tão somente a +11, +16 e +12% em Limeira. Nesta localidade, o efeito do fósforo foi nulo, quando aplicado sòzinho, mas, em média das três doses, atingiu +18% na presença de nitrogênio + potássio. Nas outras experiências também se notou maior efeito do fósforo na presença dos outros nutrientes. Terminando, os autores sugerem uma revisão nas fórmulas de adubação destinadas às áreas repetidamente adubadas com fósforo.This paper reports the results of four trials located at Araras, Avaré, Limeira, and São Carlos, in the State of São Paulo, to study the effects of N, P and K on "terra-roxa" soils. The responses to N and K were satisfactory only in the Limeira experiment, located on an area repeatedly fertilized with phosphorus in the
Book Act was a new project by AMBruno, initiated by Sophie Loss, in which artist book-makers performed and embodied the concept or essence of their books through the medium of film or performance. The exhibition at The Tetley, Leeds, comprised the originating books and corresponding video work, with live performances on Sunday 9 March 2014. Book Act took place during the 17th International Contemporary Artists' Book Fair (7th to 9th March) and the exhibition continued until 26th March 2014.
A. Paes de Camargo
Full Text Available De 1943-44 a 1945-46 realizaram-se seis experiências (três anuais, uma conduzida por dois e duas por três anos, em três localidades do Estado de São Paulo, para estudar o efeito, sôbre a batata-doce, de diversas formulas contendo sempre 60-100-40 kg/ha de N-P2O5-K2O, mas preparadas com diferentes adubos nitrogenados, fosfatados e potássicos. Em relação ao tratamento sem adubo, foram poucos os casos em que as adubações com NPK aumentaram substancialmente a produção. Nessas condições, superfosfato se mostrou ligeiramente superior à farinha de ossos e não se notou diferença entre cloreto de potássio e cinzas de café. Sulfato de amônio, que figurou na experiênca conduzida por dois anos, e torta de algodão, nas demais, em regra com portaram-se melhor do que salitre do Chile. Individualmente, as fórmulas mais eficientes foram as preparadas com superfosfato, cloreto de potássio e sulfato de amônio ou torta de algodão. Contudo, mesmo com estas, foi muito baixa a freqüência de resultados compensadores.Six experiments with sweet potatoes were located on two soil types of the State of São Paulo to study the effects of fertilizer mixtures prepared with different, N. P, and K sources, but containing always 60-100-40 kilograms of N-P(20(5-K(20 per hectare. The yield increases of fertilized over the unfertilized plots were satisfactory only in a few of the 11 annual results obtained. Under such poor conditions, superphosphate was slightly superior to bone meal and no difference was observed between coffee ashes and potassium chloride. Ammonium sulphate, in one, and cottonseed meal, in the other five trials, as a rule, were more efficient than Chilean nitrate. Individually, the mixtures prepared with superphosphate, potassium chloride, and ammonium sulphate or cottonseed meal gave the best results but even with them the frequency of satisfactory yield increases was very low.
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Brown, JP; Amaechi, BT; Bader, JD; Gilbert, GH; Makhija, SK; Lozano-Pineda, J; Leo, MC; Chuhe, C; Vollmer, WM
Objectives To better understand the effectiveness of xylitol in caries prevention in adults, and to attempt improved clinical trial efficiency. Methods As part of the Xylitol for Adult Caries Trial (X-ACT), non-cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 grams/day of xylitol, consumed by dissolving in the mouth five 1 gram lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21–80, with complete data for four dental examinations were selected from the 691 randomized into the three year trial, conducted at three sites. Acceptable inter and intra examiner reliability before and during the trial was quantified using the kappa statistic. Results The mean annualized non-cavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically non-significant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. Conclusions There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non-cavitated plus cavitated lesions were assessed. This conformed to the X-ACT trial result assessing cavitated lesions. Including non-cavitated lesion assessment in this full scale, placebo controlled, multi site, randomized, double blinded clinical trial in adults experiencing dental caries, did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration ClinicalTrials.Gov NCT00393055 PMID:24205951
Gandhi Rajiv; Jan Meryam; Smith Holly N; Mahomed Nizar N; Bhandari Mohit
Abstract Background After the Food and Drug Administration Modernization Act of 1997, the registration of all clinical trials became mandatory prior to publication. Our primary objective was to determine publication rates for orthopaedic trauma trials registered with ClinicalTrials.gov. We further evaluated methodological consistency between registration and publication. Methods We searched Clinical Trials.gov for all trials related to orthopaedic trauma. We excluded active trials and trials ...
G. P. Viégas
the results of experiments conducted during several years at three different sites of the State of São Paulo: Campinas, on terra roxa misturada soil; Ribeirão Prêto, on terra roxa legítima soil, and Engenheiro Hermilo, on glacial soil. In the Campinas experiment, beside other treatments, manure at the rate of 12.8 metric tons per hectare was compared with a mixture containing 30-90-70 kilograms per hectare of N, P2O5 and K2O respectively as sulfate of ammonia, bone meal (occasionally, superphosphate, and potash chloride, (and also with plots which received half the doses of minerals in addition to half the quantity of manure. The materials used and the rates of application per hectare in Ribeirão Prêto and Engenheiro Hermilo were: 10 metric tons of manure; 80 kilograms of P2O5 in the form of bone meal, and 50 kilograms of K2O as coffee bean ash. The asli supplied also 20 kilograms of P2O5. Each of these materials was used alone or in the possible combinations. At the three locations the manure and minerals were applied annually, before every corn crop. The results obtained in the Campinas experiment with each of the fertilizer treatments were excellent. With small differences, their effect increased in the order: minerals alone, manure alone, 1/2 manure + 1/2 minerals. At Ribeirão Prêto corn gave no response to phosphorus, whereas either manure or coffee bean ash increased considerably the yield. The combination manure-ash was not better than manure alone, showing that the potash content of the later was sufficient for the maximum yield under the conditions of the experiment. Here, manure acted principally as a potash fertilizer. At Engenheiro Hermilo potash did not affect the yield, but bone meal, as well as manure, brought out substantial increases. T increase due to the combination manure-bone meal corresponded to the addition of the increases caused by each material. Under the conditions of this experiment, on soil fairly supplied with organic matter and
Manpower Administration (DOL), Washington, DC. Bureau of Work-Training Programs.
The standards and procedures presented establish the basic rules governing the development and operation of various programs administered by the U.S. Department of Labor, Bureau of Work Programs under the Economic Opportunity Act of 1964, as amended. Basic standards relate to qualification of sponsors, eligibility of enrollees, hours of work,…
Trêves, R; Maheu, E; Dreiser, R L
Although common, hand osteoarthritis is controversial and rarely used as a model for clinical trials in osteoarthritis. We found only 13 therapeutic trials conducted in digital or trapeziometacarpal osteoarthritis between 1983 and 1994. Eleven of these trials were published. Seven were on nonsteroidal antiinflammatory drugs given either per os (two trials, meclofenamate and ibuprofen) or percutaneously (one trial each on etofenamate, ibuprofen, and ketoprofen gel, and two trials on niflumic acid gel), three were on symptomatic slow-acting drugs (glycosaminoglycanes in two trials and chondroitin sulfate in one), and three were on miscellaneous agents (the muscle relaxant idrocilamide, as a gel; the antisubstance P agent capsaicin, also as a gel; and a spa treatment). We have reviewed the methodology and findings of these trials with the goal of determining the optimal approach to realize better standardized trials in the next future for identifying symptomatic slow-acting drugs and/or "chondroprotective" agents with beneficial effects in digital osteoarthritis. PMID:7583181
Miyashita, T.; Kubík, Štěpán; Haghighi, N.; Steward, O.; Guzowski, J. F.
Roč. 29, č. 4 (2009), s. 898-906. ISSN 0270-6474 Institutional research plan: CEZ:AV0Z50110509 Keywords : hippocampus * one-trial learning * Arc Subject RIV: FH - Neurology Impact factor: 7.178, year: 2009
Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...
Conclusions: Study shows that tiotropium alone once a day is the evidence based and rationale pharmacotherapy in moderate COPD. There is no advantage or statistical significance of adding long acting β2 agonists (LABA such as formoterol to tiotropium either for 12 h (once daily or 24 h (twice daily.
Montelukast as Add-On Therapy with Inhaled Corticosteroids or Inhaled Corticosteroids and Long-Acting Beta-2-Agonists in the Management of Patients Diagnosed with Asthma and Concurrent Allergic Rhinitis (The RADAR Trial
Paul K Keith
Full Text Available OBJECTIVE: To evaluate the effectiveness of montelukast as add-on therapy for patients diagnosed with asthma and concurrent allergic rhinitis who remain uncontrolled while receiving inhaled corticosteroid (ICS monotherapy or ICS/long-acting beta-2-agonist (LABA therapy in a community practice setting.
Gazzard, G; Zhu, H; Lewis, A.; Nathwani, N.
ragmatic trials of treatment pathways can require patient awareness of treatment allocation in order to better represent clinical reality, for example when concordance with a treatment has an important effect on outcome. Conversely, masking of treating clinicians to allocation group can be impossible when full clinical assessment requires knowledge of the current treatments, resources do not permit separate teams for treatment and assessment or when such duplication of clinician contact might...
Developing systems and services for the effective and efficient management of research data as well as addressing issues around their long term curation is an area of increasing activity in UK Higher Education. This paper discusses some preliminary results from a questionnaire survey, conducted as part of the trial implementation of the Data Audit Framework Methodology at University College London (UCL). Fifty seven (57) academic and research staff from 5 designated departments and an interdi...
Nadler, David A
When a CEO leaves because of performance problems, the company typically recruits someone thought to be better equipped to fix what the departing executive couldn't--or wouldn't. The board places its confidence in the new person because of the present dilemma's similarity to some previous challenge that he or she dealt with successfully. But familiar problems are inevitably succeeded by less familiar ones, for which the specially selected CEO is not quite so qualified. More often than not, the experiences, skills, and temperament that yielded triumph in Act I turn out to be unequal to Act II's difficulties. In fact, the approaches that worked so brilliantly in Act I may be the very opposite of what is needed in Act II. The CEO has four choices: refuse to change, in which case he or she will be replaced; realize that the next act requires new skills and learn them; downsize or circumscribe his or her role to compensate for deficiencies; or line up a successor who is qualified to fill a role to which the incumbent's skills and interests are no longer suited. Hewlett-Packard's Carly Fiorina exemplifies the first alternative; Merrill Lynch's Stanley O'Neal the second; Google's Sergey Brin and Larry Page the third; and Quest Diagnostics' Ken Freeman the fourth. All but the first option are reasonable responses to the challenges presented in the second acts of most CEOs' tenures. And all but the first require a power of observation, a propensity for introspection, and a strain of humility that are rare in the ranks of the very people who need those qualities most. There are four essential steps executives can take to discern that they have entered new territory and to respond accordingly: recognition that their leadership style and approach are no longer working; acceptance of others' advice on why performance is faltering; analysis and understanding of the nature of the Act II shift; and, finally, decision and action. PMID:17286076
Full Text Available Home > Health topics A-Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks ... centers across the country. The National Institutes of Health funds much of this basic research. Screening Trials ...
Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...
Huss, Michael; Ginsberg, Ylva; Arngrim, Torben; Philipsen, Alexandra; Carter, Katherine; Chen, Chien-Wei; Gandhi, Preetam; Kumar, Vinod
Background and Objectives In the management of attention-deficit hyperactivity disorder (ADHD) in adults it is important to recognize that individual patients respond to a wide range of methylphenidate doses. Studies with methylphenidate modified release long acting (MPH-LA) in children have reported the need for treatment optimization for improved outcomes. We report the results from a post hoc analysis of a 5-week dose optimization phase from a large randomized, placebo-controlled, multicen...
An on-farm in Kenya to evaluate the merits of a strategic drenching regime against the existing control measures showed that it was difficult to get statistically significant sample sizes within individual farms and that differences in farm management existed especially where animals are communally grazed. Consequently, production data were rendered difficult to analyse and interpret. Unlike in on-station trials, it was evident that the large number of smallholder farms (up to 80) that was required for realistic statistical comparisons conflicted with the limits of logistics and funding. The strategic treatment for gastrointestinal nematodes in sheep resulted in lower mean faecal egg counts in treated animals for most of the study period but overall, there was no significant effect of strategic treatment over the existing treatments on FEC, birth weight and growth rates in lambs. Possible approaches in future studies, could include use of clusters of smallholder farms that are far apart in different treatment groups. Commonly grazed flocks can either be excluded completely in such trials or if that method of grazing is predominant, entire village or cleary designated locations could be used in different treatment groups. Even with above, the use of production data (growth rate, off-take, mortality etc) need to be handled with great caution
Pedersen, Sune; Galatius, Soren; Mogelvang, Rasmus; Davidsen, Ulla; Galloe, Anders; Abildstrom, Steen Z; Abildgaard, Ulrik; Hansen, Peter Riis; Bech, Jan; Iversen, Allan; Jorgensen, Erik; Kelbaek, Henning; Saunamaki, Kari; Madsen, Jan Kyst; Jensen, Jan Skov
patients admitted during office hours (hazards ratio, 1.04; 95% CI, 0.8 to 1.5; P=0.81). Door-to-balloon times of less than 90 minutes were achieved in 60% among patients admitted directly to an invasive center but only in 40% among transferred patients (P<0.001). Despite this difference, no difference in...... the DANAMI-2 trial. Furthermore, we analyzed the impact of patient presentation to the angioplasty center during "off hours" (4 pm to 8 am plus weekends and holidays) and the impact of being referred from noninvasive hospitals. At 3 years, 20.4% in the routinely treated population versus 19.6% in the...... DANAMI-2 trial reached the combined end point of death, reinfarction, or stroke (P=0.68), whereas the all-cause mortality was 13.0% and 13.7%, respectively (P=0.65). Patients admitted during off hours had the same risk of reaching the combined end point of death, reinfarction, or stroke compared with...
Thomas J Palmeri
Full Text Available To understand object categorization, participants are tested in experiments often quite different from how people experience object categories in the real world. Learning and knowledge of categories is measured in discrete experimental trials, those trials may or may not provide feedback, trials appear one after another, after some fixed inter-trial interval, with hundreds of trials in a row, within experimental blocks with some structure dictated by the experimental design. In the real world, outside of certain educational and vocational contexts, opportunities to learn and use categories are intermixed over time with a whole multitude of intervening experiences. It is clear from any elementary understanding of human cognition that sequential effects matter, yet this understanding is often ignored, and categorization trials are often instead treated as independent events, immune to local trial context. In this perspective, we use some of our work to illustrate some of the consequences of the fact that categorization experiments have a particular trial structure. Experimental trial context can affect performance in category learning and categorization experiments in ways that can profoundly affect theoretical conclusions.
Full Text Available The subject of this paper is to analyze the provisions of the Criminal Procedure Act relating to the general rights of victims and the rights of victims of criminal offenses against sexual freedom and human trafficking. The goal was to determine the relationship between the statutory rights of the victims and their needs, as well as to analyze how the application of these rights affects the victim’s status, a sense of security and protection. Intention was to analyze whether the Act contributes to the prevention of retraumatization and revictimization of victims and if it increases confidence in the judicial system. These effects can be achieved primarily by timely informing victims about their rights, and then by providing those rights in the practice. The analysis made is based on the experience of officials from Victims and Witnesses Support Offices. The purpose of this paper is to promote the implementation of the rights that victims have according the Criminal Procedure Act in order to enable their wellbeing.
Full Text Available Abstract Objective To determine the safety and logistic feasibility of a mass immunization strategy outside the local immunization program in the pediatric population of urban squatter settlements in Karachi, Pakistan. Methods A cluster-randomized double blind preventive trial was launched in August 2003 in 60 geographic clusters covering 21,059 children ages 2 to 16 years. After consent was obtained from parents or guardians, eligible children were immunized parenterally at vaccination posts in each cluster with Vi polysaccharide or hepatitis A vaccine. Safety, logistics, and standards were monitored and documented. Results The vaccine coverage of the population was 74% and was higher in those under age 10 years. No life-threatening serious adverse events were reported. Adverse events occurred in less than 1% of all vaccine recipients and the main reactions reported were fever and local pain. The proportion of adverse events in Vi polysaccharide and hepatitis A recipients will not be known until the end of the trial when the code is broken. Throughout the vaccination campaign safe injection practices were maintained and the cold chain was not interrupted. Mass vaccination in slums had good acceptance. Because populations in such areas are highly mobile, settlement conditions could affect coverage. Systemic reactions were uncommon and local reactions were mild and transient. Close community involvement was pivotal for information dissemination and immunization coverage. Conclusion This vaccine strategy described together with other information that will soon be available in the area (cost/effectiveness, vaccine delivery costs, etc will make typhoid fever control become a reality in the near future.
Ottesen, LH; Aagaard, N K; Kiszka-Kanowitz, M;
Octreotide seems to have a beneficial effect on variceal bleeding, and long-term administration for the prevention of rebleeding is currently being evaluated. Experimental studies have suggested a beneficial effect of chronic octreotide treatment on renal function, while clinical studies have shown...... variable effects. Twenty-five cirrhotic patients with portal hypertension were randomized in a double-blind design to placebo or a single subcutaneous dose of a long-acting formulation of octreotide (octreotide-LAR) (20 mg). Renal function tests were performed before dosing and repeated after 30 days. The...... octreotide along with a reduction of insulin-like growth factor I (IGF-I) (P <.01) and an increase of IGF binding protein 1 (P <.05) were demonstrated. No effect of octreotide was observed on GFR, ERPF, or filtration fraction (GFR/ERPF). Changes in clearance and extraction fraction of sodium and lithium...
... Trials Clinical Trial Websites How Do 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 ( ...
Purpose: The United Kingdom Coordinating Committee on Cancer Research anal cancer trial demonstrated the benefit of combined modality treatment (CMT) using radiotherapy (RT), infusional 5-fluorouracil, and mitomycin C over RT alone. The present study retrospectively examines the impact of the recommended 6-week treatment gap and local RT boost on long-term outcome. Methods and Materials: A total of 577 patients were randomly assigned RT alone or CMT. After a 6-week gap responders received a boost using either additional external beam radiotherapy (EBRT) (15 Gy) or iridium-192 implant (25 Gy). The effect of boost, the gap between initial treatment (RT alone or CMT) and boost (Tgap), and overall treatment time (OTT) were examined for their impact on outcome. Results: Among the 490 good responders, 436 (89%) patients received a boost after initial treatment. For boosted patients, the risk of anal cancer death decreased by 38% (hazard ratio [HR]: 0.62, 99% CI 0.35–1.12; p = 0.04), but there was no evidence this was mediated via a reduction in locoregional failure (LRF) (HR: 0.90, 99% CI 0.48–1.68; p = 0.66). The difference in Tgap was only 1.4 days longer for EBRT boost, compared with implant (p = 0.51). OTT was longer by 6.1 days for EBRT (p = 0.006). Tgap and OTT were not associated with LRF. Radionecrosis was reported in 8% of boosted, compared with 0% in unboosted patients (p = 0.03). Conclusions: These results question the benefit of a radiotherapy boost after a 6-week gap. The higher doses of a boost may contribute more to an increased risk of late morbidity, rather than local control.
Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe
Objective To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Design Cohort embedded pragmatic randomized controlled trial. Setting Trials registered on ClinicalTrials.gov. Participants 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails s...
The Hazardous Waste Remedial Actions Program (HAZWRAP) Support Contractor Office plays a major role in the Department of Defense (DOD) Installation Restoration Program (IRP). The IRP is DOD's program for identifying past disposal sites and for eliminating hazards to public health and the environment. Since 1986, HAZWRAP has conducted a variety of projects for the US Air Force and Navy at the request of the Department of Energy (DOE). This paper discusses HAZWRAP's involvement in the IRP, some of the lessons learned during the course of this relationship, and initiatives that are being taken to remove sites from the IRP. The DOE may have an interest in HAZWRAP's experiences with the IRP in planning for its equivalent program
Battistutto, R. [Instruments and Special Devices Dept. (UTP), Carlo Toso, Danieli Automation, Buttrio, Udine (Italy)
Production flexibility and product quality are key subjects that can significantly influence the competitiveness of a steel-making company; recently, they can even affect its profitable permanence on the market. Danieli Automation, thanks to 25-year experience in automation systems for the rolling mill, can offer their customers effective products and solutions specifically designed and developed for total control on the finished product quality. This target is achieved by optimization of yield, availability of the installations and use of the human resources. Results of the above experience and development is the IIITEST instrumentation product family for in-line surface inspection quality control. (author)
Production flexibility and product quality are key subjects that can significantly influence the competitiveness of a steel-making company; recently, they can even affect its profitable permanence on the market. Danieli Automation, thanks to 25-year experience in automation systems for the rolling mill, can offer their customers effective products and solutions specifically designed and developed for total control on the finished product quality. This target is achieved by optimization of yield, availability of the installations and use of the human resources. Results of the above experience and development is the IIITEST instrumentation product family for in-line surface inspection quality control. (author)
Essack, Zaynab; Koen, Jennifer; Slack, Catherine; Lindegger, Graham; Newman, Peter A
Community engagement is crucial to ongoing development and testing of sorely needed new biomedical HIV prevention technologies. Yet, negative trial results raise significant challenges for community engagement in HIV prevention trials, including the early termination of the Cellulose Sulfate microbicide trial and two Phase IIb HIV vaccine trials (STEP and Phambili). The present study aimed to explore the perspectives and experiences of civil society organization (CSO) representatives regarding negative HIV prevention trial results and perceived implications for future trials. We conducted in-depth interviews with 14 respondents from a broad range of South African and international CSOs, and analyzed data using thematic analysis. CSO representatives reported disappointment in response to negative trial results, but acknowledged such outcomes as inherent to clinical research. Respondents indicated that in theory negative trial results seem likely to impact on willingness to participate in future trials, but that in practice people in South Africa have continued to volunteer. Negative trial results were described as having contributed to improving ethical standards, and to a re-evaluation of the scientific agenda. Such negative results were identified as potentially impacting on funding for trials and engagement activities. Our findings indicate that trial closures may be used constructively to support opportunities for reflection and renewed vigilance in strategies for stakeholder engagement, communicating trial outcomes, and building research literacy among communities; however, these strategies require sustained resources for community engagement and capacity-building. PMID:22360605
Full Text Available Sybille Steinbacher hat in ihrem Band Volksgenossinnen Aufsätzen versammelt, in denen die Rolle von Frauen bei der Durchsetzung des Ordnungsmodells „Volksgemeinschaft“ untersucht wird. Gegenstand der analytischen Beschreibungen sind das Selbstverständnis und die Erfahrungsgeschichten von Frauen, die als anerkannte Mitglieder der nationalsozialistischen Gesellschaft Handlungsräume in Anspruch nahmen. Insbesondere in den Kriegsjahren vergrößerten sich Tätigkeitsfelder und Aufstiegschancen für „Volksgenossinnen”. Die Beiträge des Bandes erweitern die bisher noch geringen Kenntnisse über Deutungsmuster und Handlungsweisen einer großen Zahl von so genannten arischen, nicht verfolgten Frauen im Nationalsozialismus.Sybille Steinbacher’s volume Female Comrades (Volksgenossinnen contains essays that examine the role of women during the propagation of the nationalistic structural model of Germany as an “ethnic community.” The subject of the analytical descriptions is the self-conception and historical experience of women, who as recognized members of the national socialist community laid claim to specific spheres of action. The war years, in particular, offered these “female comrades” chances for promotion and to expand their fields of activity. The contributions in this volume build on the rather minimal existing knowledge about the interpretive patterns and manners of conduct of a large number of non-persecuted so-called Aryan women during National Socialism.
The paper presents examples of difficulties experienced by the German authorities during the 210Po incident in Hamburg in December 2006, which can be blamed, to varying degrees, on poor internal or external communication. The cases presented draw on the large amount of newspaper coverage of the event, controversial images, actions undertaken by inexperienced emergency responders and, to a lesser extent, anecdotal evidence from the 'worried well' among the emergency responders. The experience obtained has been examined and evaluated, and it is apparent that the inclusion of a communication strategy as part of the response to an intentional attack using radioactive materials, including the threat thereof, could dramatically improve the effectiveness of the emergency services. As a result, a new communication strategy has been developed and is beginning to be adopted by the German national authorities involved in the defence against nuclear hazards. The essential elements of the new communication strategy are described here, with the aim of producing a customized, homogeneous and appropriate response to future incidents involving radioactive materials. (author)
Full Text Available ... Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ... lifestyle changes, such as exercising more, getting more sleep, keeping mentally active, or eating nutritious foods, can ...
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Group, Sustainable Trials Study
Currently, few researchers think about the carbon footprint of their trial. The Sustainable Trials Study Group reports that clinical trials are carbon intensive and suggests ways to make them more efficient
Full Text Available ... on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose ...
Klingelhoefer, F.; Berthet, T.; Lallemand, S.; Schnurle, P.; Lee, C.-S.; Liu, C.-S.; McIntosh, K.; Theunissen, T.
An active seismic experiment has been conducted across the southern Ryukyu margin east of Taiwan over the whole trench-arc-backarc system in May 2009. Twenty-four ocean bottom seismometers (OBS) were deployed from the Ryukyu trench to the southern Okinawa trough over the Ryukyu arc and forearc. Wide angle seismic data were recorded by the OBS array while coincident reflection seismic data were acquired using a 6 km long streamer and a 6600 cubic inch seismic airgun array. Results from tomographic inversion of 21091 travel time picks along this line allowed us to image crustal structures of the Ryukyu margin down to a depth of 25 km. The transect has been designed to provide a better seismic velocity structure of the subduction zone in a highly deformed area that has produced an M8 earthquake in 1920. The line crosses a seismic cluster of earthquakes which source mechanisms are still poorly understood. The subducting oceanic crust of the Huatung Basin is about 5-6 km thick. The underlying mantle exhibits low seismic velocities around 7.8 km/s suggesting some hydrothermal alterations or alteration of the upper mantle through faults generated by the flexure of the subducting plate as it enters the subduction. Low velocities, up to 4.5 km/s, associated with the accretionary wedge are well imaged from the trench back to the Nanao forearc. A major result concerns the abrupt termination of the buttress at the rear of the accretionary wedge. Despite the low resolution of the tomographic inversion near the subduction interface, several lines of evidence supporting the presence of a low velocity zone beneath the toe of the forearc buttress could be established. The Moho beneath the Ryukyu non-volcanic arc is located at a depth around 25 km depth.
Meyer, W P; Habib, A G; Onayade, A A; Yakubu, A; Smith, D C; Nasidi, A; Daudu, I J; Warrell, D A; Theakston, R D
During the past decade, effective snake antivenoms have become scarce in northern Nigeria. As a result, many patients severely envenomed by the saw-scaled or carpet viper (Echis ocellatus), which is responsible for more than 95% of the snake bites in the region, did not receive effective treatment and mortality and morbidity increased. To combat this crisis, a new monospecific ovine Fab antivenom (EchiTab) is being developed. Its theoretical advantages over conventional equine F(ab')2 antivenom are a more rapid tissue penetration and larger apparent volume of distribution (the volume of [tissue] fluid in which the the antivenom would be uniformly distributed to achieve the observed plasma concentration). In a preliminary study, two vials (20 ml; 1.0 g of protein) of EchiTab rapidly and permanently restored blood coagulability and cleared venom antigenemia in seven envenomed patients. Four experienced early reactions that responded to epinephrine. In a randomized comparative trial of one vial (10 ml; 0.5 g protein) of EchiTab or four ampules (40 ml; 2.12 g of protein) of Institute Pasteur Serum (Ipser) Africa polyspecific F(ab')2 antivenom, there were fewer reactions, but only 36% and 35% of patients, respectively, showed permanent restoration of coagulability, with the remainder requiring further doses. This suggests that 0.5 g (one vial) of EchiTab is approximately equivalent to 2.12 g (four ampules) of Ipser Africa antivenom, and that a higher initial dose will be required for most patients. Measurements of circulating venom and antivenom levels reflected the clinical events. PMID:9129531
Act 588 of the Republic of Ghana entitled, Atomic Energy Commission Act, 2000, amends and consolidates the Atomic Energy Commission Act, 204 of 1963 relating to the establishment of the Atomic Energy Commission. Act 588 makes provision for the Ghana Atomic Energy Commission to establish more institutes for the purpose of research in furtherance of its functions and also promote the commercialization of its research and development results. (E.A.A.)
Background and purpose: In a prospective multi-center phase II trial, we investigated the MammoSite[reg] Radiation Therapy System, a new device for delivering intracavitary brachytherapy following breast conserving surgery. The MammoSite[reg] is a dual lumen, closed ended catheter with a small, spherical inflatable balloon and a port for connecting a remote afterloader to the central lumen. We analyzed the surgical procedure and placement of the MammoSite[reg], treatment planning and radiation delivery complications and cosmesis, as well the comfort for the patients. Patients and methods: Between 2002 and 2004 a total of 32 patients (pts) were implanted using the MammoSite[reg]. The reference isodose was defined 1 cm from the balloon surface. We analyzed the post-implant anatomic position of the applicator and the geometric form of the balloon via ultrasound, CT and X-ray, related side effects, cosmetic outcome and patient quality of life. Results: Twenty-three out of 32 patients (72%) were eligible for MammoSite[reg] intracavitary brachytherapy. Twenty-eight percentage had to be excluded because of different reasons. Eleven patients were treated with primary brachytherapy with a total dose of 34 Gy (2x3.4 Gy) and 12 had a boost with a mean dose of 13.3 Gy (range: 7.5-15 Gy; 2x2.5 Gy) combined with EBRT and doses ranged between 46 and 50 Gy. In three cases a balloon rupture occurred. We observed two abscesses within 3 months of implantation and serious seroma development in 10 patients (39%). Skin related side effects were erythema in 21 patients (91%), hyperpigmentation in 13 patients (56%) and teleangiectasia in six patients (26%) after mean follow-up 20 months. Conclusions: The MammoSite[reg] Radiation Therapy System is a feasible treatment modality for intracavitary brachytherapy of breast cancer after breast conserving surgery. The advantage of the system is only one applicator is necessary for the delivery of a fractionated radiotherapy. In addition, patient
Pavlovsky, Santiago; Lastiri, Francisco
The purpose of this study was to evaluate the trends in complete remission (CR) rate, disease-free survival (DFS), and overall survival (OS) through 35 years of Grupo Argentino de Tratamiento de la Leucemia Aguda (GATLA) clinical trials. A total of 1,254 adult patients with Hodgkin's Lymphoma were evaluated according to seven consecutive protocols. This 35-year study was divided into three phases. The patients in the first phase (1968-1985) were treated with CVPP (cyclophosphamide/vinblastine/procarbazine/prednisone) plus involved-field radiotherapy (IFRT). In the CVPP regimen, cyclophosphamide and vinblastine were administered intravenously on day 1 and prednisone and procarbazine were administered orally on days 1-14 every 28 days. The second phase (1986-1996) used mainly reinforced CVPP with cyclophosphamide and vinblastine on days 1-8 plus IFRT. The third phase (1997-2003) used ABVD(doxorubicin/bleomycin/vinblastine/dacarbazine) plus IFRT. In clinical stage I/II, the CR rate was 86% in 252 patients treated in the first phase and DFS and OS were 57% and 78% at 5 years and 50% and 71% at 10 years. The second phase had 148 patients with clinical stage I/II disease, and the CR rate was 91%, 5-year DFS and OS were 78% and 90%, and 10-year DFS and OS were 70% and 83%. The third phase had 182 patients with clinical stage I/II disease, and the CR rate was 95%, 5-year DFS and OS were 87% and 96%, and 10-year DFS and OS were not reached. The statistical difference was P = 0.016 in terms of CR and P < 0.001 in terms of DFS and OS. In the first phase of 394 patients with clinical stage III/IV disease, the CR rate was 71%, DFS and OS at 5 years were 37% and 62%, and DFS and OS at 10 years were 32% and 53%. In the second phase of 164 patients with clinical stage III/IV disease, the CR rate was 84%, DFS and OS at 5 years were 66% and 80%, and DFS and OS at 10 years were 60% and 75%. In the third phase of 114 patients with clinical stage III/IV disease, the CR rate was 88% and
Farmer Andrew J; Holman Rury R; Darbyshire Julie L; Jenkins Nicholas; Lawton Julia; Hallowell Nina
Abstract Background Trial research has predominantly focused on patient and staff understandings of trial concepts and/or motivations for taking part, rather than why treatment recommendations may or may not be followed during trial delivery. This study sought to understand why there was limited attainment of the glycaemic target (HbA1c ≤6.5%) among patients who participated in the Treating to Target in Type 2 Diabetes Trial (4-T). The objective was to inform interpretation of trial outcomes ...
Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena
After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs. PMID:23561044
Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.
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The first nuclear application of PAA dispersant to improve corrosion product removal during LPR (Long-path recirculation) cleanup occurred at Byron Unit 1 in spring 2011. The main conclusions and lessons learned are as follows: -) there were no significant problems with application of PAA during LPR with an initial PAA concentration of about 650 ppb; -) a reasonable estimate of the additional iron mass removed due to the presence of PAA is 5-9 kg. The qualification work, application details and an assessment of the results are the first focus of this paper. The second part of this paper summarizes the online experience to date at the Exelon and STP (South Texas Project) plants on the effects of dispersant on -) blowdown iron removal efficiency, -) steam generator heat transfer efficiency and -) ion exchange resin performance
... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false The trial work period. 220.170 Section 220.170 Employees' Benefits RAILROAD RETIREMENT BOARD REGULATIONS UNDER THE RAILROAD RETIREMENT ACT DETERMINING DISABILITY Trial Work Period and Reentitlement Period for Annuitants Disabled for Any...
....1592 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY... of disability benefit under title II of the Social Security Act (i.e., child's benefits based on... the trial work period in determining whether your disability ended at any time after the trial...
Kleijnen, J.; Knipschild, P; ter Riet, G
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 MEASURE...
The use of dispersants in pressurized water reactors (PWRs) has been extensively qualified by EPRI over the past 14 years. Building on the demonstrated success for reducing the rate of corrosion product accumulation within recirculating steam generators (SGs), dispersant injection has more recently been qualified for application during the post-outage startup long-path recirculation cleanup period and for application during SG wet lay-up. These latter two applications are also of value for plants with once through SGs. Dispersant application during the long-path recirculation (LPR) cleanup process can reduce the amount of corrosion products available for transport to the SGs by more effectively flushing the condensate and feedwater systems prior to initiating flow to the SGs. The first application occurred at Byron 1 in Spring 2011 under EPRI sponsorship. Extensive qualification and preparation led to a successful outcome. Dispersant was added in two batches while the unit was transitioning from short-path to full LPR cleanup. The target maximum concentration was 800 ppb, while the largest measured dispersant concentration during the application was approximately 650 ppb. There were no difficulties in decreasing the dispersant concentration below the target threshold value prior to reaching Mode 1 entry at the conclusion of the cleaning application. The application was very successful, resulting in the following conclusions: - Approximately 10-20 lb (5-9 kg) of additional iron mass was removed during the LPR cleanup as a result of dispersant addition. - It appears that the added cleanup resulting from dispersant addition during the outage caused a significant decrease in the amount of iron transported to the SGs during the early part of the subsequent cycle. Specifically, on the order of 10-15 lb (5-7 kg) less iron was transported than would otherwise have been expected based on prior plant experience. The qualification work, application details, and an assessment
first year. In three of the four trials superphosphate was much superior to hyperphosphate and mainly to Serrote-phosphate (from the Serrote hill, near Juquiá. State of São Paulo; in the other trial the last two types of phosphates gave similar results and were only a little inferior to superphosphate. Florida-phosphate, included in two experiments, was practically equal to byperphosphate. The superiority of superphosphate came chiefly from its greater efficiency in the first year; star-ling from the second year the tendency was for equivalence of the phosphates studied. In the experiment conducted for five years the lime application was ineffective in the first two years, but il increased appreciably the yields in the following years. In another experiment, couduceted for two years in a move acid soil, lime was fairly effective even in the first and very effective in the second year. The addition of lime enhanced the effect of superphosphate, but affected contradictorily those of the natural phosphates.
Scardino Peter T
Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.
An Act to establish a Nuclear Regulatory Authority in Ghana. This Act provides for the regulation and management of activities and practices for the peaceful use of nuclear material or energy, and to provide for the protection of persons and the environment against the harmful effects of radiation; and to ensure the effective implementation of the country’s international obligations and for related matters. This Act replaced the Radiation Protection Instrument, of 1993 (LI 1559).
O. J. Boock
Full Text Available No período de 1946 a 1950 foram conduzidas duas experiências era Tupi Paulista e três em Mococa, para estudar o efeito, sôbre a produção da batatinha (Solarium tuberosum L., da adição de farelo de cacau a adubações minerais contendo 40-120-60 e 80-120-60 kg/ha de N-P(20(5-K(20. O farelo em apreço, que é um dos subprodutos da indústria do chocolate e consta principalmente de películas das amêndoas (sementes de cacau, foi adicionado em doses que variaram entre 255 e 1100 kg/ha. A adição de farelo deprimiu um pouco a produção em Tupi, sendo que a depressão foi maior no tratamento que recebeu a menor dose de nitrogênio; em Mococa seu efeito foi positivo e apreciável na presença de 80-120-60, mas praticamente nulo quando adicionado a 40-120-60. Isso parece indicar que, na sua decomposição, o farelo deprimiu as disponibilidades do solo em nitrogênio assimilável. Assim, para estudar a conveniência de sua adição, dever-se-ía empregá-lo com bastante antecedência ao plantio; para aplicá-lo ao ser este efetuado, como nas experiências relatadas, o farelo deveria ser previamente curtido.This paper reports the results obtained in five experiments conducted from 1946 to 1950 and designed to study the effect of the addition of cocoa-shell meal to mineral fertilizers supplying 40-120-60 and 80-120-60 kilograms of N-P(20(5-K2O per hectare. The mentioned meal, which is a by-product of the cocoa industry and consists essentially of the shells of the cocoa beans, was applied at rates varying from 255 to 1,100 kilograms per hectare. Two of the experiments were located at Tupi Paulista and the other three at Mococa, State of São Paulo. On the average, in the Tupj experiments the addition of cocoa-shell meal reduced slightly the potato yields, the reduction being greater in the presence of the fertilizer containing the smaller quantity of nitrogen; at Mococa it increased appreciably the yield in the presence of 80-120-60, but was
The case described in this paper involves the interpretation of language contained in the Texas Clean Air Act Texas Health and Safety Code Ann. Sections 382.001-382.141. The State of Texas, on behalf of the Texas Air Control Board, brought suit in the District Court of Erath County, Texas against the F/R Cattle Company, Inc., alleging that, because of odors emanating from the company's cattle feeding facility, the company was violating the Clean Air Act. The Board is granted the power and duty to administer the Clean Air Act and is directed to accomplish the purposes of the Act through the control of air contaminants by all practical and economically feasible methods. Described here is the evidence presented at and proceedings of the trial
Fojo, Antonio Tito; Bates, Susan E.
The Oncologist’s Clinical Trial Results section welcomes both positive and negative results in an effort to share information, speed discovery, and inform the field. Clinical Trial Results submissions have shown how succinctly the salient features of a submission can be presented, with more in-depth information to be found online.
Full Text Available ... determine if the drug can be approved for use. A Phase I trial tests an experimental treatment ... the correct drug dosage. A Phase II trial uses more people (100 to 300). While the emphasis ...
Full Text Available ... the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...
Full Text Available ... Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical ... researchers may gather information about experimental treatments, their risks, and how well they work compare existing therapies ...
Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.
Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.
Full Text Available Abstract Background New antimalarial regimens, including artemisinin-based combination therapies (ACTs, have been adopted widely as first-line treatment for uncomplicated malaria. Although these drugs appear to be safe and well-tolerated, experience with their use in Africa is limited and continued assessment of safety is a priority. However, no standardized guidelines for evaluating drug safety and tolerability in malaria studies exist. A system for monitoring adverse events in antimalarial trials conducted in Uganda was developed. Here the reporting system is described, and difficulties faced in analysing and interpreting the safety results are illustrated, using data from the trials. Case description Between 2002 and 2007, eleven randomized, controlled clinical trials were conducted to compare the efficacy, safety, and tolerability of different antimalarial regimens for treatment of uncomplicated malaria in Uganda. The approach to adverse event monitoring was similar in all studies. A total of 5,614 treatments were evaluated in 4,876 patients. Differences in baseline characteristics and patterns of adverse event reporting were noted between the sites, which limited the ability to pool and analyse data. Clinical failure following antimalarial treatment confounded associations between treatment and adverse events that were also common symptoms of malaria, particularly in areas of lower transmission intensity. Discussion and evaluation Despite prospectively evaluating for adverse events, limitations in the monitoring system were identified. New standardized guidelines for monitoring safety and tolerability in antimalarial trials are needed, which should address how to detect events of greatest importance, including serious events, those with a causal relationship to the treatment, those which impact on adherence, and events not previously reported. Conclusion Although the World Health Organization has supported the development of
Patrick I Okonta
Full Text Available The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.
José Luiz V. Rocha
Full Text Available Numa experiência de adubação da mamoneira (Ricinus communis L,, conduzida por dois anos em solo derivado do arenito Botucatu, com vegetação de cerrado, superfosfato simples foi comparado, na presença de NK, com fosforita de Olinda, fosfato de Araxá e misturas que continham 1/3, 1/2 ou 2/3 da dose total de P2O5 (65 kg/ha como superfosfato, sendo o resto fornecido por um dos fosfatos naturais. Em média dos dois anos, a produção do tratamento sem adubo foi de 196 kg/ha, ao passo que as dos melhores tratamentos oscilaram em tôrno de 650 kg/ha. Embora muito superiores à do tratamento sem adubo, as últimas produções foram apenas sofríveis, aparentemente devido à insuficiência das adubações usadas e a fatores adversos no segundo ano. Empregados sòzinhos, os fosfatos naturais mostraram-se muito inferiores ao superfosfato; nas misturas, porém, não diferiram um do outro nem do adubo padrão. O efeito das misturas diminuiu quando se reduziu a contribuição de superfosfato, mas as diferenças foram pequenas. O efeito residual de PK, verificado no segundo ano, em parte da experiência, correspondeu a cêrca de 1/3 da resposta a NPK, obtida nos canteiros que receberam essa adubação nos dois anos.In the experiment reported, conducted for two years on poor soil derived from the Botucatu sandstone, superphosphate was compared, in the presence of NK with Olinda and Araxa phosphates (ground natural phosphates, and mixtures containing 1/3, 1/2 and 2/3 of the total dosis of P2O5 (65 kilograms per hectare as superphosphate, the remaining being supplied by one of the natural phosphates. The average yield of the two years was only 196 kg/ha (kilograms per hectare in the unfertilized plots and varied around 650 kg/ha in the better treatments. Although much higher than that of the unfertilized treatment, the latter yields were unsatisfactory, apparently due to the use of inadequate rates of application, deficiency of elements other than those
Haire, Bridget; Jordens, Christopher
The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. PMID:26193849
... services—including both ER visits and inpatient hospitalizations—ACT team members are also well-connected with local hospitals and have the ability to work with hospital and emergency room staff. ACT teams ...
National Oceanic and Atmospheric Administration, Department of Commerce — The Marine Mammal Protection Act (MMPA or Act) prohibits, with certain exceptions, the "take" of marine mammals in U.S. waters and by U.S. citizens on the high...
Syed, Ali; Vogel, Wolfhard J.
Viewgraphs on ACTS Data Center status report are included. Topics covered include: ACTS Data Center Functions; data flow overview; PPD flow; RAW data flow; data compression; PPD distribution; RAW Data Archival; PPD Audit; and data analysis.
... Center Statistical and Data Management Center Glossaries Sites Clinical Trials About the Trial Process Trials Open to Enrollment Recent Study Results Access to Published Data Clinical Trials Resources Committees Executive Scientific Resource Community General Information ...
This Act governs all activities related to nuclear installations in the United Kingdom. It provides for the licensing procedure for nuclear installations, the duties of licensees, the competent authorities and carriers of nuclear material in respect of nuclear occurrences, as well as for the system of third party liability and compensation for nuclear damage. The Act repeals the Nuclear Installations (Licensing and Insurance) Act 1959 and the Nuclear Installations (Amendment Act) 1965 except for its Section 17(2). (NEA)
Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.
A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design
Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996. PMID:22727048
A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial: study rationale and design
Full Text Available Abstract Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE, multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996.
When ACT UP is remembered as the pinnacle of postmodern activism, other forms and forums of activism that were taking place during that time--practices that were linked, related, just modern, in dialogue or even opposition to ACT UP's "confrontational activism"--are forgotten. In its time, ACT UP was embedded in New York City, and a larger world,…
The aim of this thesis was to investigate and give a deeper understanding of consumers’ trial buying process of a service innovation in an online environment. More specifically, this thesis tries to clarify the connection between consumers’ adoption decisions, external influences and the service experience of an innovation in an online environment. A trial buying process was studied in order to increase the case company HOK-Elanto’s knowledge of how their customers make adoption decisions whe...
Indirect speech acts are frequently used in verbal communication, the interpretation of them is of great importance in order to meet the demands of the development of students' communicative competence. This paper, therefore, intends to present Searle' s indirect speech acts and explore the way how indirect speech acts are interpreted in accordance with two influential theories. It consists of four parts. Part one gives a general introduction to the notion of speech acts theory. Part two makes an elaboration upon the conception of indirect speech act theory proposed by Searle and his supplement and development of illocutionary acts. Part three deals with the interpretation of indirect speech acts. Part four draws implication from the previous study and also serves as the conclusion of the dissertation.
Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first
Full text: The objectives of the experiment were to disseminate irradiated retail foods to the domestic publics and to test consumer acceptance on irradiated ground chilli and ground pepper. Market trials of irradiated ground chilli and ground pepper were carried out at 2 local markets and 4 in Bangkok and Nontaburi in 2005-2007. Before the start of the experiment, processing room, gamma irradiation room and labels of the products were approved by Food and Drug Administration, Thailand. 50 grams of irradiated products were packaged in plastic bags for the market trials. 688 and 738 bags of ground chilli and ground pepper were sold, respectively. Questionnaires distributed with the products were commented by 59 consumers and statistically analyzed by experimental data pass program. 88.1 and 91.4 percents of the consumers were satisfied with the quality and the price, respectively. 79.7% of the consumers chose to buy irradiated ground chilli and ground pepper because they believed that the quality of irradiated products were better than that of non-irradiated ones. 91.5% of the consumers would certainly buy irradiated chilli and pepper again. Through these market trials, it was found that all of the products were sold out and the majority of the consumers who returned the questionnaires was satisfied with the irradiated ground chilli and ground pepper and also had good attitude toward irradiated foods
Godskesen, T M; Kihlbom, U; Nordin, K; Silén, M; Nygren, P
While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels and former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann-Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of close ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups. PMID:25904313
As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)
Pullar, T; Kumar, S; Feely, M
Compliance with treatment can be an important determinant of the outcome of clinical trials. To date there is no completely satisfactory method of measuring compliance and some of the most widely used methods are inadequate. The various methods of measuring compliance and how they have been applied to clinical trials are described, and improvements in the standard of the measurement and reporting of compliance in clinical trials are suggested.
I show that the quantum measurement problem can be understood if the measurement is seen as a ``speech act'' in the sense of modern language theory. The reduction of the state vector is in this perspective an intersubjectice -- or better a-subjective -- symbolic process. I then give some perspectives on applications to the ``Mind-Body problem''.
Lynch, Kevin G.; Cary, Mark; Gallop, Robert; Ten Have, Thomas R.
In the context of randomized intervention trials, we describe causal methods for analyzing how post-randomization factors constitute the process through which randomized baseline interventions act on outcomes. Traditionally, such mediation analyses have been undertaken with great caution, because they assume that the mediating factor is also randomly assigned to individuals in addition to the randomized baseline intervention (i.e., sequential ignorability). Because the mediating factors are t...
This Act provides for the establishment of a Radiological Protection Board to undertake research and advise on protection from radiation hazards. Its functions include provision of advice to Government departments with responsibilities in relation to protection of sectors of the community or the community as a whole against the hazards of ionizing radiation. The Act, which lays down that the Board shall replace certain departments concerned with radiation protection, repeals several Sections of the Radioactive Substances Act 1948 and the Science and Technology Act 1965. (NEA)
Comprehensive Prep for ACT Verbal. Every year, students pay 1,000 and more to test prep companies to prepare for the verbal sections of the ACT. Now you can get the same preparation in a book. The verbal sections are not easy. There is no quick fix that will allow you to "beat" the ACT, but it is very learnable. If you study hard and master the techniques in this book, your score will improve-significantly. The ACT cannot be "beaten." But it can be mastered-through hard work, analytical thought, and by training yourself to think like a test writer. Many of the exercises in this book are design
Prasad, Neeli R.; Cetin, Bilge Kartal; Moran, Humberto;
This deliverable contains all the details on the planning, description of business cases, business goals stakeholders, IT infrastructure, evaluation guidelines and other aspects of the pilot trials, that are envisioned for demonstrating the benefits of the ASPIRE middleware platform. These pilot...... trials mainly consist of controlled and carefully designed experiments that will be organized either by those partners of the consortium who have previous experience on demos or similar events for small and medium enterprises (SMEs), or by other institutions that have accepted to test the ASPIRE...
Hughes, John Gareth; Russell, Wanda; Breckons, Matthew; Richardson, Janet; Lloyd-Williams, Mari; Molassiotis, Alex
Background Nested qualitative studies within clinical trials provide data on patients’ experiences of receiving trial interventions and can inform and improve trial designs. The present study explored patients’ experiences of participating in a randomised controlled trial of acupressure wristbands for chemotherapy related nausea. Methods A randomised three-group sham-controlled trial was carried out to evaluate the effectiveness of acupressure wristbands in the management of chemotherapy-rela...
This Act, entitled the Radiation Emitting Devices Act, is concerned with the sale and importation of radiation emitting devices. Laws relating to the sale, lease or import, labelling, advertising, packaging, safety standards and inspection of these devices are listed as well as penalties for any person who is convicted of breaking these laws
Crittenden, M.; Kohrt, H.; Levy, R.; Jones, J.; Camphausen, K.; Dicker, A.; Demaria, S.; Formenti, S.
Preclinical evidence of successful combinations of ionizing radiation with immunotherapy has inspired testing the translation of these results to the clinic. Interestingly, the preclinical work has consistently predicted the responses encountered in clinical trials. The first example came from a proof-of-principle trial started in 2001 that tested the concept that growth factors acting on antigen-presenting cells improve presentation of tumor antigens released by radiation and induce an absco...
The New Criminal Procedure Act that will soon become effective will also determine a transformation of the position and of the rights of the people involved in legal relations that are specific to the criminal trial. This study is meant to identify the main characteristics of the current criminal trials, as seen in the Romanian legal system. The lengthy process through which Romania became a full-rights member of the European Union caused a radical transformation of the existing criminal tria...
Full Text Available ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ... 000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, they ...
Suciu, S; Sylvester, R; Iversen, P;
The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...
Full Text Available ... can include imaging tests that produce pictures of what is inside the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...
Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet;
trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient...
Jones, B. [University Coll., Dublin (Ireland)
Under the E.C. Joule program in 1989, a European network started on 18 sites a replicated production trial of an asian plant to produce biomass. The trials show that it is possible to successfully establish a Miscanthus crop under a wide range of climatic and edaphic conditions in Europe. Tests and results are presented. (TEC).
Full Text Available ... disease or prevent a disease from returning. Supportive Care Trials In supportive care trials, researchers look for ways to make life ... groups, and various types of social interventions. Supportive care interventions are not intended to treat or cure ...
Suciu, S; Sylvester, R; Iversen, P; Christensen, I; Denis, L
The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...
Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... IV trial for drugs or devices takes place after the U.S. Food and Drug Administration approves their ...
ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medi...
Hernán, Miguel A; Robins, James M
Ideally, questions about comparative effectiveness or safety would be answered using an appropriately designed and conducted randomized experiment. When we cannot conduct a randomized experiment, we analyze observational data. Causal inference from large observational databases (big data) can be viewed as an attempt to emulate a randomized experiment-the target experiment or target trial-that would answer the question of interest. When the goal is to guide decisions among several strategies, causal analyses of observational data need to be evaluated with respect to how well they emulate a particular target trial. We outline a framework for comparative effectiveness research using big data that makes the target trial explicit. This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls. PMID:26994063
Frewer, L. J.; Coles, D.; van der Lans, I A; Schroeder, D.; Champion, K.; Apperley, J. F.
The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. F...
Rapport, F; Storey, M; Porter, A; Snooks, H.; Jones, K; Peconi, J.; Sanchez, A.; Siebert, S.; Thorn, K.; Clement, C.; Russell, I T
BACKGROUND: Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influen...
The review of the Act has progressed in stages. The first stage was conducted by the staff of the Atomic Energy Control Board (AECB) and catalogued previously identified difficulties with the Act. The second stage was a preliminary examination of the Act by an Interdepartmental Working Group (IWG). The IWG was formed in 1982 at the direction of the President of the AECB. It was instructed to review all matters relating to the administration of, and experience with, the Act and to examine these matters in as much detail as was required to resolve each point raised during the review. The IWG was composed of representatives of the AECB (which administers the Act), the Department of Energy, Mines and Resources, the Department of Finance, the Department of Insurance, the Department of Justice, and the Treasury Board Secretariat
Stepanyan, Sofia T; Sidhu, Shawn S; Bath, Eraka
Competency to stand trial is interpreted as a protected due process right for all defendants and is defined as a defendant's fundamental knowledge and understanding of the criminal charges being filed, roles and procedures within the courtroom, and a general ability to work with the defense counsel. Questions of competency are most often raised by the judge, defense, or the prosecution, and competency evaluations are most often completed by psychiatrists or psychologists with forensic training or work experience. Mental illness, intellectual disability, developmental disorders, and developmental immaturity are the 4 main factors considered in most juvenile competency evaluations. PMID:26593118
This paper provided an outline of Canada's Clean Air Act and examined some of the regulatory changes that will occur as a result of its implementation. The Act is being introduced to strengthen the legislative basis for taking action on reducing air pollution and GHGs, and will allow the government to regulate both indoor and outdoor air pollutants and GHGs. The Act will require the Ministers of the Environment and Health to establish national air quality objectives, as well as to monitor and report on their attainment. The Canadian Environmental Protection Act will be amended to enable the government to regulate the blending of fuels and their components. The Motor Vehicle Fuel Consumption Standards Act will also be amended to enhance the government's authority to regulate vehicle fuel efficiency. The Energy Efficiency Act will also be expanded to allow the government to set energy efficiency standards and labelling requirements for a wider range of consumer and commercial products. The Act will commit to short, medium and long-term industrial air pollution targets. Regulations will be proposed for emissions from industry; on-road and off-road vehicles and engines; and consumer and commercial products. It was concluded that the Government of Canada will continue to consult with provinces, territories, industries and Canadians to set and reach targets for the reduction of both indoor and outdoor air pollutants and GHG emissions. 6 figs
The new Radiation Protection Act (1988:220) entered into force in Sweden on July 1st, 1988. This book presents the Act as well as certain regulations connected to it. As previously, the main responsibility for public radiation protection will rest with one central radiation protection authority. According to the 1988 Act, the general obligations with regard to radiation protection will place a greater responsibility than in the past on persons carrying out activities involving radiation. Under the act, it is possible to adjust the licensing and supervisory procedures to the level of danger of the radiation source and the need for adequate competence, etc. The Act recognises standardised approval procedures combined with technical regulations for areas where the risks are well known. The Act contains several rules providing for more effective supervision. The supervising authority may in particular decide on the necessary regulations and prohibitions for each individual case. The possibilities of using penal provisions have been extended and a rule on the mandatory execution of orders has been introduced. The Ordinance on Radiation Protection (1988:293) designates the National Institute of Radiation Protection (SSI) as the central authority referred to in the Radiation Protection Act. The book also gives a historic review of radiation protection laws in Sweden, lists regulations issued by SSI and presents explanations of radiation effects and international norms in the area. (author)
Part II of This Act came into force on 1 September 1983 and is concerned with nuclear installations. Its main purpose is to amend the Nuclear Installations Act 1965 to give effect to the provisions of two Protocols amending the Paris Convention on nuclear third party liability and the Brussels Convention Supplementary to the Paris Convention respectively. The principal effect of these modifications is to increase the sums available to meet claims for nuclear damage. The United Kingdom is a Party to both Conventions and the provisions of the 1983 Act will enable it to ratify the Protocols. (NEA)
Jo, Booil; Asparouhov, Tihomir; Muthen, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks
Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be…
Australian Science Education Project, Toorak, Victoria.
This is a National Trial Print of a unit on petroleum developed for the Australian Science Education Project. The package contains the teacher's edition of the written material and a script for a film entitled "The Extraordinary Experience of Nicholas Nodwell" emphasizing the uses of petroleum and petroleum products in daily life and designed to…
National Oceanic and Atmospheric Administration, Department of Commerce — The Marine Pollution Prevention Act of 2008 implements the International Convention for the Prevention of Pollution from Ships, including related Protocols (MARPOL)...
described as knowledge producers and exhibitions and art works as instances of knowledge production. Acts of Research: Knowledge Production in Contemporary Arts between Knowledge Economy and Critical Practices analyses this development. The academic discussion of knowledge production in the arts has taken...... with an awareness of larger political, economic, geographical and art-related aspects. The concept of ‘acts of research’ is suggested as a way to understand knowledge production as a creative act in which research carried out in relation to a specific material challenges and resists the protocols of conventional...... knowledge production and norms. It is argued that knowledge production is not a stable concept, but may indicate a series of acts of research that allow each art practice to participate in a collective constitution of both the term and its practice....
National Oceanic and Atmospheric Administration, Department of Commerce — The Clean Water Act (CWA) establishes the basic structure for regulating discharges of pollutants into U.S. waters and regulating quality standards for surface...
National Oceanic and Atmospheric Administration, Department of Commerce — The National Environmental Policy Act (NEPA) was the first major environmental law in the United States and established national environmental policies for the...
National Oceanic and Atmospheric Administration, Department of Commerce — The Abandoned Shipwreck Act of 1987 (ASA) affirms the authority of state governments to claim ownership to, protect, and manage abandoned shipwrecks on state...
Social Security Administration — The Affordable Care Act (ACA) is a federal statute enacted with a goal of increasing the quality and affordability of health insurance. Through a web service, CMS...
National Oceanic and Atmospheric Administration, Department of Commerce — The purpose of the Endangered Species Act (ESA) is to protect and recover imperiled species and the ecosystems upon which they depend. The U.S. Fish and Wildlife...
National Oceanic and Atmospheric Administration, Department of Commerce — The Energy Policy Act (EPA) addresses energy production in the United States, including: (1) energy efficiency; (2) renewable energy; (3) oil and gas; (4) coal; (5)...
G. P. Viégas
was used at the dosages of 2.5, 5 and 10 metric tons to the hectare, either alone or supplementd with phosphorus (bone meal, potassium (coffee beans ash, or both. All the fertilizers were applied only in the first year, 1943-44, but corn was planted in the same plots for three consecutive yars. The yield increase due to phosphorus was small, apparently because the area used for the experiment had been fertilized with phosphates in the previous crops. Potassium increased considerably the yield in the first year and showed excellent residual effect in the two succeeding years. In the absence of potash the sludge product acted poorly, but in the presence of that nutrient its effect increased appreciably. The 5 and 10 tons rates gave satisfactory results; however, they increased comparatively more the production of stover than the grain yield. The nitrogen of the sludge product acts fairly quickly, but apparently little of it remains in the soil for the succeeding crops. For better utilization of its nitrogen, the sludge product should be applied frequently (perhaps annually and at moderate rates, supplemented with potash and phosphate, according to the soil.
Full Text Available ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...
Full Text Available ... out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or ... specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...
Full Text Available ... Drug Administration typically requires Phase 1, 2 and 3 trials to be conducted to determine if the ... subjects usually ranges from several hundred to about 3,000 people. If the U.S. Food and Drug ...
Katz, J N; Losina, E; Lohmander, L S
To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...
... Human Services Search the NIH Website NIH Employee Intranet Staff Directory En Español Site Menu Home Health ... am thinking about participating? Xsandra/iStock Risks and benefits Clinical trials involve risks, just as routine medical ...
Full Text Available ... ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging ... getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as ...
Full Text Available ... Researchers may study the role of caregivers, support groups, and various types of social interventions. Supportive care ... trial tests an experimental treatment on a small group of often healthy people (20 to 80), to ...
U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...
Full Text Available ... Learn More Participating in Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in ...
Full Text Available ... in this topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ...
The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.
Full Text Available ... Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in this topic was provided by the National ...
Baruah, Abhinav Ray; Deva, Anish; Sarma, Arun
It has been shown that a non-contact force acts between two macroscopic physical objects held close together, which is not associated with the gravitational and electrostatic force. An experiment was conducted with objects of different mass, material and geometry to find the magnitude and properties of this apparent or pseudo force. The order of magnitude was found to be 10-5 and it remained constant for all types of objects while only the coefficient increased as the distance between the objects reduced. It only started acting at small distances and failed to make a body move if it experienced static friction from any contact surface. The nature of the force was found to be attractive as well as repulsive. Due to gravitation being a solely attractive force, it was eliminated as a possible reason for the pseudo force. The experiment was performed twice, once by grounding the apparatus and then again without grounding. The order of the force remained the same for both cases. As the test objects were held by hand, they were grounded through the human body. Also, none of the objects used were in contact with each other for the duration of this work, preventing any contact electrification. Due to these factors, the force was not considered electrostatic in nature.
LeBlanc, Thomas W.; Lodato, Jordan E.; Currow, David C; Abernethy, Amy P.
Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. Through their experience with designing and deploying a social-marketing based protocol, the authors show that a carefully crafted recruitment and retention protocol can be effective.
Sellers, Christopher J; Lee, Hana; Chasela, Charles; Kayira, Dumbani; Soko, Alice; Mofolo, Innocent; Ellington, Sascha; Hudgens, Michael G; Kourtis, Athena P; King, Caroline C; Jamieson, Denise J; van der Horst, Charles
Background/Aims Retaining patients in prevention of mother-to-child transmission of HIV studies can be challenging in resource limited settings, where high lost to follow-up (LTFU) rates have been reported. In this paper, we describe the effectiveness of methods used to encourage retention in the Breastfeeding, Antiretrovirals, and Nutrition (BAN) study and analyze factors associated with LTFU in the study. Methods The BAN clinical trial was designed to evaluate the efficacy of 3 different mother-to-child HIV transmission prevention strategies. Lower than expected participant retention prompted enhanced efforts to reduce LTFU during the conduct of the trial. Following study completion, we employed regression modeling to determine predictors of perfect attendance and variables associated with being LTFU. Results During the study, intensive tracing efforts were initiated after the first 1686 mother-infant pairs had been enrolled, and 327 pairs were missing. Sixty of these pairs were located and had complete data obtained. Among the 683 participants enrolling after initiation of intensive tracing efforts, the LTFU rate was 3.4%. At study's end, 290 (12.2%) of the 2369 mother-infant pairs were LTFU. Among successfully traced missing pairs, relocation was common and three were deceased. Log-binomial regression modeling revealed higher maternal hemoglobin and older maternal age to be significant predictors of perfect attendance. These factors and the presence of food insecurity were also significantly associated with lower rates of LTFU. Conclusions In this large HIV prevention trial, intensive tracing efforts centered on reaching study participants at their homes succeeded in finding a substantial proportion of LTFU participants, and were very effective in preventing further LTFU during the remainder of the trial. The association between food insecurity and lower rates of LTFU is likely related to the study's provision of nutritional support, including a family maize
Schünemann, Holger J; Ventresca, Matthew; Crowther, Mark; Briel, Matthias; Zhou, Qi; Garcia, David; Lyman, Gary; Noble, Simon; Macbeth, Fergus; Griffiths, Gareth; DiNisio, Marcello; Beyene, Joseph; Mbuagbaw, Lawrance; Neumann, Ignacio; Van Es, Nick; Brouwers, Melissa; Brozek, Jan; Guyatt, Gordon; Levine, Mark; Moll, Stephan; Santesso, Nancy; Streiff, Michael; Baldeh, Tejan; Florez, Ivan; Gurunlu Alma, Ozlem; Solh, Ziad; Ageno, Walter; Marcucci, Maura; Bozas, George; Zulian, Gilbert; Maraveyas, Anthony; Lebeau, Bernard; Buller, Harry; Evans, Jessica; McBane, Robert; Bleker, Suzanne; Pelzer, Uwe; Akl, Elie A
Introduction Parenteral anticoagulants may improve outcomes in patients with cancer by reducing risk of venous thromboembolic disease and through a direct antitumour effect. Study-level systematic reviews indicate a reduction in venous thromboembolism and provide moderate confidence that a small survival benefit exists. It remains unclear if any patient subgroups experience potential benefits. Methods and analysis First, we will perform a comprehensive systematic search of MEDLINE, EMBASE and The Cochrane Library, hand search scientific conference abstracts and check clinical trials registries for randomised control trials of participants with solid cancers who are administered parenteral anticoagulants. We anticipate identifying at least 15 trials, exceeding 9000 participants. Second, we will perform an individual participant data meta-analysis to explore the magnitude of survival benefit and address whether subgroups of patients are more likely to benefit from parenteral anticoagulants. All analyses will follow the intention-to-treat principle. For our primary outcome, mortality, we will use multivariable hierarchical models with patient-level variables as fixed effects and a categorical trial variable as a random effect. We will adjust analysis for important prognostic characteristics. To investigate whether intervention effects vary by predefined subgroups of patients, we will test interaction terms in the statistical model. Furthermore, we will develop a risk-prediction model for venous thromboembolism, with a focus on control patients of randomised trials. Ethics and dissemination Aside from maintaining participant anonymity, there are no major ethical concerns. This will be the first individual participant data meta-analysis addressing heparin use among patients with cancer and will directly influence recommendations in clinical practice guidelines. Major cancer guideline development organisations will use eventual results to inform their guideline
This Act will enter into force on 1 January 1992. The scope of the Act is extensive as, in addition to ionizing radiation, it will also apply to activities involving exposure to natural radiation and non-ionizing radiation. Its purpose is to prevent and restrict harmful effects to health resulting from radiation. The basic principles of the Act are that the practice involving radiation should be justified; radiation protection should be optimized; and radiation doses should be as low as reasonably achievable. Licensed organisations using radiation will be responsible for the safety of the activity involving exposure to radiation and for having available the appropriate expertise to this effect. The required so-called safety licence provides the regulatory control to ensure that radiation is used sensibly, that the equipment and shields are technically acceptable and the operating personnel is competent, and that the radioactive waste is dealt with appropriately. The Radiation Act will also apply to nuclear activities within the scope of the 1987 Nuclear Energy Act
Woody, William Douglas; Viney, Wayne
An experiment was designed to explore effects of general pretrial publicity in sexual assault trials. Four pretrial publicity conditions (no publicity, neutral news media, prodefendant, and antidefendant) in the form of simulated newspaper articles were presented to 356 participants. Participants subsequently read a mock rape trial summary and reported verdicts. In the absence of pretrial publicity related to sexual assault, women were more likely than men to convict the defendant, but the presence of sexual assault pretrial publicity in any form eliminated sex differences in conviction rates. PMID:18175495
... Introduction Cancer CAM Clinical Trials Introduction What are clinical trials? A clinical trial is one of the final ... and effective. What are the different types of clinical trials? Treatment trials test new treatments (like a new ...
The Clean Air Act amendments alter the complex laws affecting atmospheric pollution and at the same time have broad implications for energy. Specifically, the Clean Air Act amendments for the first time deal with the environmental problem of acid deposition in a way that minimizes energy and economic impacts. By relying upon a market-based system of emission trading, a least cost solution will be used to reduce sulfur dioxide (SO2) emissions by almost 40 percent. The emission trading system is the centerpiece of the Clean Air Act (CAA) amendments effort to resolve energy and environmental interactions in a manner that will maximize environmental solutions while minimizing energy impacts. This paper will explore how the present CAA amendments deal with the emission trading system and the likely impact of the emission trading system and the CAA amendments upon the electric power industry
I have come to the conclusion that for high school physics classroom and laboratory experiences, simpler is better! In this paper I describe a very simple and effective lab experience that my AP students have thoroughly enjoyed year after year. I call this lab exercise "Time Trials." The experiment is simple in design and it is a lot of fun for…
Gidofalvi, Gyozo; Pedersen, Torben Bach
hot issue in the area of spatio–temporal databases . While existing Moving Object Simulators (MOSs) address different physical aspects of mobility, they neglect the important social and geo–demographical aspects of it. This paper presents ST–ACTS, a Spatio–Temporal ACTivity Simulator that, using...... various geo–statistical data sources and intuitive principles, models the so far neglected aspects. ST–ACTS considers that (1) objects (representing mobile users) move from one spatio–temporal location to another with the objective of performing a certain activity at the latter location; (2) not all users...
This Act, which entered into force on 1 september 1989, contains a series of provisions dealing with different subjects: increase of public financing for British Nuclear Fuels plc, amendment of the Nuclear Installations Act 1965 regarding the powers of the Health and Safety Executive to recover expenses directly from nuclear operators and obligation of the UKAEA to take out insurance or other financial security to cover its liability and finally, measures to enable the UK to ratify the IAEA Convention on Assistance in Case of a Nuclear Accident or Radiological Emergency
Rosas, Juan M.; Garcia-Gutierrez, Ana; Callejas-Aguilera, Jose E.
Three experiments explored renewal in conditioned taste aversion after different amounts of extinction. In Experiment 1, three groups of rats received a single conditioning trial where a saccharin solution was paired with LiCl, followed by 3 extinction trials, and a two-trial test. Groups differed in the context where they received each of the…
Through an examination of The Trial by Kafka I attempt to show that the depiction of the Court apparatus is dynamically related to the commission of unconscious crimes of the type we encounter in our patients. To provide a context for the novel, I discuss Kafka's biography and some possible unconscious motivations. My goal is to show how the concept of a particular type of superego pressure can be used to understand the subtle irony in The Trial. Although Joseph K.'s behavior frequently involves oedipal crimes, there are many preoedipal themes that help account for his experience of the Court. I contrast this psychoanalytic understanding of K.'s guilt with that of literary critics who interpret The Trial as an allegory of guilt but who minimize the psychological dimensions. PMID:8856824
Ding, Mingzhou; Chen, Youghong; Knuth, Kevin H.; Bressler, Steven L.; Schroeder, Charles E.
In electro-neurophysiology, single-trial brain responses to a sensory stimulus or a motor act are commonly assumed to result from the linear superposition of a stereotypic event-related signal (e.g. the event-related potential or ERP) that is invariant across trials and some ongoing brain activity often referred to as noise. To extract the signal, one performs an ensemble average of the brain responses over many identical trials to attenuate the noise. To date, h s simple signal-plus-noise (SPN) model has been the dominant approach in cognitive neuroscience. Mounting empirical evidence has shown that the assumptions underlying this model may be overly simplistic. More realistic models have been proposed that account for the trial-to-trial variability of the event-related signal as well as the possibility of multiple differentially varying components within a given ERP waveform. The variable-signal-plus-noise (VSPN) model, which has been demonstrated to provide the foundation for separation and characterization of multiple differentially varying components, has the potential to provide a rich source of information for questions related to neural functions that complement the SPN model. Thus, being able to estimate the amplitude and latency of each ERP component on a trial-by-trial basis provides a critical link between the perceived benefits of the VSPN model and its many concrete applications. In this paper we describe a Bayesian approach to deal with this issue and the resulting strategy is referred to as the differentially Variable Component Analysis (dVCA). We compare the performance of dVCA on simulated data with Independent Component Analysis (ICA) and analyze neurobiological recordings from monkeys performing cognitive tasks.
Minow, Mary; Coyle, Karen; Kaufman, Paula
Explains the USA PATRIOT (Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism) Act, passed after the September 11 terrorist attacks, and its implications for libraries and patron records. Considers past dealings with the FBI; court orders; search warrants; wiretaps; and subpoenas. Includes:…
Rasmussen, Anders Bo
, Denmark and the United States signed an act on July 19, 1862, wherein the U.S. Navy agreed to unload “all negroes, mulattoes, or persons of color, delivered from on board vessels seized in the prosecution of the slave trade.” Yet, despite the two countries’ mutual interests in employing “laborers of...
This Act provides for the control of dumping of wastes and other substances in the ocean in accordance with the London Convention of 1972 on Prevention of Marine Pollution by the Dumping of Wastes and other Matter to which Canada is a Party. Radioactive wastes are included in the prohibited and restricted substances. (NEA)
This act provides for the establishment of the Atomic Energy Control Board. The board is responsible for the control and supervision of the development, application and use of atomic energy. The board is also considered necessary to enable Canada to participate effectively in measures of international control of atomic energy
... qualifications; credentials and suitability for employment, including prior employers, academic organizations... students who are working at VA to receive academic credit for the experience. ] POLICIES AND PRACTICES FOR...) (Privacy Act) and guidelines issued by OMB (65 FR 77677), December 12, 2000. Approved: October 21,...
Gaal, Mate; Baer, Sylke; Bloodworth, Thomas J.; Guelle, Dieter; Lewis, Adam M.; Mueller, Christina; Scharmach, Martina
The performance of mine detecting instruments is embedded in the behavior of a complex system. The total reliability is always composed of the intrinsic physical detection capability of the sensor, application/environmental influences and human factors. The intrinsic capability and some application factors can be investigated in laboratory measurements. Human factors, other application factors and the overall reliability, can only be evaluated in blind field trials in which the probability of detection (PoD) and false alarm rate (FAR) are measured statistically. Both of these approaches are included in CEN Workshop Agreement CWA 14747:2003, which standardizes detector testing in Humanitarian Demining. We report here the results of a study to investigate how to optimize such testing. For efficient and statistically valid field trials, the number, types and burial depths of targets, and the number of test lanes, soil types, repetitions and operators need to be carefully chosen. Laboratory results should be used to help construct field trial protocols and also to help distinguish the different contributions to the PoD and FAR, to determine where to improve insufficient performance. In this study, four models of metal detector were tested in three field trials and in the laboratory. The repeatability of the field trials is assessed, taking into account operator training and experience. Results of the laboratory tests are compared with results of the field trials and used to construct a "modular model" of the system, as used in nondestructive testing. The conclusions are, in principle, applicable to trials of other types of sensor.
Lai, Tze Leung; Lavori, Philip William; Shih, Mei-Chiung
We review adaptive designs for clinical trials, giving special attention to the control of the Type I error in late-phase confirmatory trials, when the trial planner wishes to adjust the final sample size of the study in response to an unblinded analysis of interim estimates of treatment effects. We point out that there is considerable inefficiency in using the adaptive designs that employ conditional power calculations to reestimate the sample size and that maintain the Type I error by using certain weighted test statistics. Although these adaptive designs have little advantage over familiar group-sequential designs, our review also describes recent developments in adaptive designs that are both flexible and efficient. We also discuss the use of Bayesian designs, when the context of use demands control over operating characteristics (Type I and II errors) and correction of the bias of estimated treatment effects. PMID:21838549
In this paper we introduce a class of right S-acts called retractable S-acts which are right S-acts with homomorphisms into their all subacts.We also give some classifications of monoids by comparing such acts with flatness properties.
Vestergaard, Maria Quvang Harck; Olesen, Mette; Helmer, Pernille Falborg
’ of mobility (Jensen 2013:111) such as the urban environment, and the infrastructures. Walking has indeed also a ‘software dimension’ as an embodied performance that trigger the human senses (Jensen 2013) and which is closely related to the habitus and identity of the individual (Halprin 1963). The...... individual perception of ‘walkability’ is based upon a subjective judgement of different physical factors, such as sidewalk width, traffic volumes and building height (Ewing and Handy 2009:67). And iIn order to understand the act of walking it is therefore necessary to create a vocabulary to understand how...... and why the individuals evaluate, interpret and act (Bourdieu 1984), and how this affects their choice to walk. Therefore it could be questioned if whether an assessment of the physical environment is sufficient to identify all the factors that influence the individual perception of ‘walkability’, or...
This Act provides for the development of atomic energy in the United Kingdom and for its control. It details the duties and powers of the competent Minister, in particular his powers to obtain information on and to inspect materials, plant and processes, to control production and use of atomic energy and publication of information thereon. Also specified is the power to search for and work minerals and to acquire property. (NEA)
This Reference Book contains a current copy of the Toxic Substances Control Act and those regulations that implement the statute and appear to be most relevant to DOE activities. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (202/586-2609).
Speech act has developed from the work of linguistic philosophers and originates in Austin's observation and study. It was the particular search for the eonstative, utterances which describe something outside the text and can therefore be judged true or false that prompted John L. Austin to direct his attention to the distinction with so -called performa-tires. The two representative linguists are Aus-tin and Searle.
As the majority of professional classical singers earn a significant part of their living in opera, it is vital that conservatoires and studios are able to provide fit-for-purpose education for these trainee artists. As opera productions today are increasingly influenced by the trends in cinema and live-streamed media, this study sought to identify and clarify the range and detail of acting and performance skills required of opera singers in this evolving professional environment. A significa...
This Act provides for the establishment of the Radiological Protection Institute of Ireland and dissolves An Bord Fuinnimh Nuicleigh (the Board), transferring its assets and liabilities to the Institute. It sets out a range of radiation protection measures to be taken by various Ministers in the event of a radiological emergency and gives effect at national level to the Assistance Convention, the Early Notification Convention and the Physical Protection Convention. The Institute is the competent Irish authority for the three Conventions. (NEA)
Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... experimental treatment on a small group of often healthy people (20 to 80), to judge its safety ...
Full Text Available ... to find out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or ... universities and medical centers across the country. The National Institutes of ...
Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... to obtain preliminary data on whether the drug works in people who have a certain disease or ...
Reimer, C; Lødrup, A B; Smith, G;
of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...
Olesen, Anne Estrup; Nielsen, Lecia Møller; Larsen, Isabelle Myriam;
: The study was a randomized, double-blinded, placebo-controlled, crossover trial in healthy males. Esophageal electrical, thermal, mechanical, and chemical stimulations were performed, pain perception was rated, and referred pain areas were drawn. Sensitization was induced by intraluminal esophageal acid...
Full Text Available ... are usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, ... hundred to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial ...
... Reports Clinician Tools Clinician Tools Home Guidelines and Best Practices Topic Reviews Algorithms, Screens, Toolkits Provider Education Provider ... about federally and privately supported clinical research in human volunteers. Site gives information about a trial's purpose, who may participate, locations, and phone ... Forms State and Local Resources Strat Plan FY 2014-2020 VA Plans, Budget, & ...
Full Text Available ... usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 ... to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, ...
Kraus, V B; Blanco, F J; Englund, M;
The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from b...
... Home Apps APIs Widgets Order Publications Skip Nav HIV/AIDS Clinical Trials Home > Clinical Trials Español small ... Renal (Kidney) Complications/Damage Skin Diseases FDA-Approved HIV Drugs Abacavir Atazanavir Atripla Cobicistat Combivir Complera Darunavir ...
Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials.
Gentile, Massimo; Zirlik, Katja; Ciolli, Stefania; Mauro, Francesca R; Di Renzo, Nicola; Mastrullo, Lucia; Angrilli, Francesco; Molica, Stefano; Tripepi, Giovanni; Giordano, Annamaria; Di Raimondo, Francesco; Selleri, Carmine; Coscia, Marta; Musso, Maurizio; Orsucci, Lorella; Mannina, Donato; Rago, Angela; Giannotta, Angela; Ferrara, Felicetto; Herishanu, Yair; Shvidel, Lev; Tadmor, Tamar; Scortechini, Ilaria; Ilariucci, Fiorella; Murru, Roberta; Guarini, Attilio; Musuraca, Gerardo; Mineo, Giuseppe; Vincelli, Iolanda; Arcari, Annalisa; Tarantini, Giuseppe; Caparrotti, Giuseppe; Chiarenza, Annalisa; Levato, Luciano; Villa, Maria Rosaria; De Paolis, Maria Rosaria; Zinzani, Pier Luigi; Polliack, Aaron; Morabito, Fortunato
Recently, encouraging results in terms of safety and efficacy have been obtained using bendamustine-rituximab (BR) in untreated chronic lymphocytic leukaemia (CLL) patients enrolled in a phase II study. Here, we report a retrospective international multicenter study of CLL patients treated with BR as front-line therapy. The cohort included 279 patients with progressive CLL from 33 centers (29 Italian, 3 Israeli and 1 German) who received at least 1 cycle of BR as first-line treatment during the 2008-2014 period. The primary objective of this study was to evaluate the efficacy and safety of BR administered as front-line therapy, outside of controlled clinical trials. Median age was 70 years (range, 43-86 years); 62.4% were males and 35.8% had Binet stage C. Forty-two patients (15.2%) were unfit (cumulative illness rating scale [CIRS] score ≥7), and 140 (50.2%) had creatinine clearance ≤70 ml/min. Fluorescent in situ hybridisation analysis, available for 192 cases, showed that 21 (10.9%) had del11q and 18 (9.4%) del17p. The overall response rate (ORR) was 86.4%, with a complete remission rate of 28%. Patients with del17p had an ORR of 66.7%. After median follow-up of 24 months, the 2-year progression-free survival (PFS) was 69.9%; CIRS ≥7, immunoglobulin heavy-chain variable-region (IGHV) unmutated status, del17p and BR dose intensity <80% were independently associated with shorter PFS. Grade III or IV neutropenia, thrombocytopenia, and anaemia were observed in 25.9%, 15.4%, and 15.1% of patients, respectively. Twenty-four patients (8.6%) had severe infections. BR is also an effective and safe regimen for untreated CLL patients, outside of controlled clinical trials. PMID:27127905
Kemal Sinan Özmen
This study follows three pre-service teachers during three academic semesters in which they took an acting course for teachers and participated in practicum with a special focus on rehearsing and developing their teacher identities. In order to create the necessary context for them, an acting course for pre-service teacher education was designed in parallel with a model which is based on an influential acting theory. This model, namely the BEING (Believe, Experiment, Invent, Navigate, Generat...
Østervig, R M; Sonne, A; Rasmussen, L S
the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... starting enrolment before 2010 to 63.2% after 2010 (24/38, P randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...
O Cathain, A.; Goode, J.; Drabble, S J; Thomas, K.J.; Rudolph, A; Hewison, J.
Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the...
Mazur, James E
Two experiments on discrete-trial choice examined the conditions under which pigeons would exhibit exclusive preference for the better of two alternatives as opposed to distributed preference (making some choices for each alternative). In Experiment 1, pigeons chose between red and green response keys that delivered food after delays of different durations, and in Experiment 2 they chose between red and green keys that delivered food with different probabilities. Some conditions of Experiment...
California Department of Resources — The California Land Conservation Act of 1965 - commonly referred to as the Williamson Act - is the State's primary program for the conservation of private land in...
Mazur, James E.
Parallel experiments with rats and pigeons examined whether the size of a pre-trial ratio requirement would affect choices in a self-control situation. In different conditions, either 1 response or 40 responses were required before each trial. In the first half of each experiment, an adjusting-ratio schedule was used, in which subjects could…
Unger, Thomas; Kintscher, Ulrich; Kappert, Kai;
The ONTARGET trial programme tested the effects of the angiotensin AT1 receptor blocker (ARB), telmisartan, alone or in combination with the angiotensin converting enzyme (ACE) inhibitor, ramipril, in more than 25.000 patients at high cardiovascular risk including diabetes on a combined endpoint....... Telmisartan thus proved to be the first and so far the only representative of the ARB class that can be used as an alternative to the "gold standard" ACE-inhibitor, ramipril, in patients at high cardiovascular risk with or without hypertension. © 2009 Bentham Science Publishers Ltd....... consisting of cardiovascular death, non-fatal stroke or myocardial infarction and hospitalisation for congestive heart failure. Patient selection and study procedures followed the previous HOPE trial. In the parallel TRANSCEND study, nearly 6.000 patients, all intolerant to ACE inhibition, were subjected...
McAlindon, T. E.; Driban, J. B.; Henrotin, Y.;
members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and......The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct, and...... reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the...
The polycystic ovarian syndrome (PCOS) is characterized by hyperandrogenism and associated with obesity and impaired glucose metabolism. Despite the high prevalence of PCOS and the considerable clinical impact, the precise interplay between metabolism and hyperandrogenemia is not entirely clear. To analyse the effects of intravenous lipid and heparin infusion on circulating androgen levels in healthy women, we performed a randomized controlled cross-over trial. 12 healthy young women durin...
Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.
Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....
Impact of efalizumab on patient-reported outcomes in high-need psoriasis patients: results of the international, randomized, placebo-controlled Phase III Clinical Experience Acquired with Raptiva (CLEAR trial [NCT00256139
Full Text Available Abstract Background Chronic psoriasis can negatively affect patients' lives. Assessing the impact of treatment on different aspects of a patient's health-related quality of life (HRQOL is therefore important and relevant in trials of anti-psoriasis agents. The recombinant humanized IgG1 monoclonal antibody efalizumab targets multiple T-cell-dependent steps in the immunopathogenesis of psoriasis. Efalizumab has demonstrated safety and efficacy in several clinical trials, and improves patients' quality of life. Objective: To evaluate the impact of efalizumab on HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis, including a large cohort of High-Need patients for whom at least 2 other systemic therapies were unsuitable because of lack of efficacy, intolerance, or contraindication. Methods A total of 793 patients were randomized in a 2:1 ratio to receive efalizumab 1 mg/kg/wk (n = 529 or placebo (n = 264 for 12 weeks. The study population included 526 High-Need patients (342 efalizumab, 184 placebo. The treatment was evaluated by patients using the HRQOL assessment tools Short Form-36 (SF-36 and Dermatology Life Quality Index (DLQI. Other patient-reported assessments included the Psoriasis Symptom Assessment (PSA, a visual analog scale (VAS for itching, and the Patient's Global Psoriasis Assessment (PGPA. Results Efalizumab was associated with improvements at Week 12 from baseline in patient-reported outcomes, both in the total study population and in the High-Need cohort. Among all efalizumab-treated patients, the DLQI improved by 5.7 points from baseline to Week 12, relative to an improvement of 2.3 points for placebo patients (P P Conclusion A 12-week course of efalizumab improved HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis. The benefits of efalizumab therapy in High-Need patients were similar to those observed in the total study population, indicating
Jenden, C. M.
During 1993, Canada, France, Germany and the United Kingdom will be participating in the Smoke and Obscurants Countermeasures Materials Evaluation Tests (SOCMET). The tests will be carried out under the auspices of the NATO Army Armaments Group, AC/225, Panel VI, Sub-Panel 7 whose interests include multispectral smoke screening systems. The tests will comprise two sets of trials; one under cold climate conditions in Quebec, Canada, during February/March 1993 and the other in temperate conditions in Bourges, France during September 1993. This paper provides an insight into the management and aims of SOCMET. The evaluations will be seeking to identify candidate materials which create effective obscurant screens in the visible, infrared and millimetric bands of the electromagnetic spectrum. These materials will be disseminated through a range area dispersal. A key element of the trials will be the evaluation of field test instrumentation which may eventually lead to the development of standardized evaluation techniques. Following the trials, a scientific workshop will be held to review the results. A final report will be presented to NATO which will form the basis of future collaborative developments on multispectral screening systems leading towards standard NATO documentation on smoke and obscurant systems.
Fürdös, Irene; Fazekas, Judit; Singer, Josef; Jensen-Jarolim, Erika
In human medicine clinical trials are legally required for drug development and approval. In contrast, clinical trials in small animal cancer patients are less common and legally perceived as animal experiments. Comparative oncology has been recognized as a method to speed up the development of medications by introducing animal patients with naturally developing tumours. In such cases, using animal patients would generate more robust data, as their spontaneous disease resembles the “real life...
Full Text Available BACKGROUND: Preparatory activity based on a priori probabilities generated in previous trials and subjective expectancies would produce an attentional bias. However, preparation can be correct (valid or incorrect (invalid depending on the actual target stimulus. The alternation effect refers to the subjective expectancy that a target will not be repeated in the same position, causing RTs to increase if the target location is repeated. The present experiment, using the Posner's central cue paradigm, tries to demonstrate that not only the credibility of the cue, but also the expectancy about the next position of the target are changed in a trial by trial basis. Sequences of trials were analyzed. RESULTS: The results indicated an increase in RT benefits when sequences of two and three valid trials occurred. The analysis of errors indicated an increase in anticipatory behavior which grows as the number of valid trials is increased. On the other hand, there was also an RT benefit when a trial was preceded by trials in which the position of the target changed with respect to the current trial (alternation effect. Sequences of two alternations or two repetitions were faster than sequences of trials in which a pattern of repetition or alternation is broken. CONCLUSIONS: Taken together, these results suggest that in Posner's central cue paradigm, and with regard to the anticipatory activity, the credibility of the external cue and of the endogenously anticipated patterns of target location are constantly updated. The results suggest that Bayesian rules are operating in the generation of anticipatory activity as a function of the previous trial's outcome, but also on biases or prior beliefs like the "gambler fallacy".
Ciceri, Piera; Tizzoni, Paola; Pierro, Luigia
Key-words: Polar science, Earth science, Theatre, Hands on activities The legendary Antarctic Expedition of sir E. Shackleton and his crew of 27 aboard the Endurance (1914/16) trapped in the Antarctic ice has become the starting point to learn about Polar Science and Climate Change. While the students were involved into this incredible adventure by the astonishing images of the Australian photographer Frank Hurley (who joined the crew), they discovered the world in which this story happened. Students were then involved in hands-on activities and role plays and have become the writers of the play "Uomini a scienza ai confini del mondo". They act the story of Shackelton's expedition and they tell at the same time to the audience about ice pack, ice cores and their role in understanding the past of the climate, physical and geographical characteristic of polar regions, thermal phenomena related to adaptations of polar animals, solar radiation at different latitude, day/night duration. The theater was the place to "stage" some scientific experiments and to explain the current research carried out in polar regions and their importance in climate change studies and to stress some similarities between Antarctica and space. The project was carried out from teachers of science, letters and geography and was born in collaboration with the "Piccolo Teatro di Milano" and the association "Science Under 18" with the support of a professional actor and director and was played for other schools at "EXPO 2015" in Milano (Italy). In our opinion drama activities improve reading comprehension, and both verbal and non-verbal communication skills. To be able to write and to act, students need a deep understanding of contents. Arts, including theatre, are a good key to involve emotionally students. To have an audience different from their own teachers and classmates offers a real task and the opportunity to play and let grow real skills.
Einstein's general theory of relativity assumes that photons don't change frequency as they move from Sun to Earth. This assumption is correct in classical physics. All experiments proving the general relativity are in the domain of classical physics. This include the tests by Pound et al. of the gravitational redshift of 14.4 keV photons; the rocket experiments by Vessot et al.; the Galileo solar redshift experiments by Krisher et al.; the gravitational deflection of light experiments by Riveros and Vucetich; and delay of echoes of radar signals passing close to Sun as observed by Shapiro et al. Bohr's correspondence principle assures that quantum mechanical theory of general relativity agrees with Einstein's classical theory when frequency and gravitational field gradient approach zero, or when photons cannot interact with the gravitational field. When we treat photons as quantum mechanical particles; we find that gravitational force on photons is reversed (antigravity). This modified theory contradicts the equivalence principle, but is consistent with all experiments. Solar lines and distant stars are redshifted in accordance with author's plasma redshift theory. These changes result in a beautiful consistent cosmology.
Stafford, John E.
Reports on findings of a survey designed to discover whether higher education institutions' admission standards accept SAT I or ACT and if there is preference for either, and whether ACT could be submitted in lieu of SAT II subject tests. Eighty-six percent of the reporting schools indicated no preference; 28 schools indicated that the ACT was an…
This Act provides for the setting up of an Atomic Energy Authority for the United Kingdom. It also makes provision for the Authority's composition, powers, duties, rights and liabilities, and may amend, as a consequence of the establishment of the Authority and in connection therewith, the Atomic Energy Act, 1946, the Radioactive Substances Act 1948 and other relevant enactments. (NEA)
Morthorst, Britt; Krogh, Jesper; Erlangsen, Annette;
OBJECTIVE: To assess whether an assertive outreach intervention after suicide attempt could reduce the frequency of subsequent suicidal acts, compared with standard treatment. DESIGN: Randomised, parallel group, superiority trial with blinded outcome assessment. SETTING: Outpatient intervention a...
This colloquium is essentially devoted to the nuclear crisis and its management. As regards the nuclear crisis, it is especially about the behavior of the C.L.I. (local commissions of information) of the communication, the errors to be avoided and possible surprises. Several experiences are reported: the crisis exercise at the nuclear center of electric production (C.N.P.E.) of Saint-Laurent-des-Eaux, the experience of Cogema La hague in communication, transparency and communication for secret installations, the experience of an independent expert from the group of scientists for the information on nuclear (G.S.I.E.N.) and the local commission of information of Fessenheim. (N.C.)
The present clinical trial update consists of a review of two of eight current studies (the 10981-22023 AMAROS trial and the 10994 p53 trial) of the European Organization for Research and Treatment of Cancer Breast Cancer Group, as well as a preview of the MIND-ACT trial. The AMAROS trial is designed to prove equivalent local/regional control for patients with proven axillary lymph node metastasis by sentinel node biopsy if treated with axillary radiotherapy instead of axillary lymph node dissection, with reduced morbidity. The p53 trial started to assess the potential predictive value of p53 using a functional assay in yeast in patients with locally advanced/inflammatory or large operable breast cancer prospectively randomised to a taxane regimen versus a nontaxane regimen
Gerstlberger, Wolfgang; Knudsen, Mette Præst; Stampe, Ian
efficiency moderates the effect of market attention on new product development. The paper therefore concludes that product innovation and energy efficiency is a balancing act, focusing on one will have detrimental effects on the other! These findings point to the conclusion that researchers and practitioners......With an undifferentiated catchword ‘eco-innovation’ is a largely understudied area, but of high relevance to the society and companies given the strong focus especially by governments on grand challenges like climate change, green technologies and environmental challenges. The paper utilizes the...... 2009 European Manufacturing Survey for the Danish sub-sample including 335 manufacturing firms. Through factor analysis, the paper confirms three main focus areas of new product development in relation to production facilities: efficiency considerations, market attention and greening of innovation...
Ebert, Todd A; Carella, John A
A triple acting radial seal used as an interstage seal assembly in a gas turbine engine, where the seal assembly includes an interstage seal support extending from a stationary inner shroud of a vane ring, the interstage seal support includes a larger annular radial inward facing groove in which an outer annular floating seal assembly is secured for radial displacement, and the outer annular floating seal assembly includes a smaller annular radial inward facing groove in which an inner annular floating seal assembly is secured also for radial displacement. A compliant seal is secured to the inner annular floating seal assembly. The outer annular floating seal assembly encapsulates the inner annular floating seal assembly which is made from a very low alpha material in order to reduce thermal stress.
Gerstlberger, Wolfgang; Stampe, Ian; Knudsen, Mette Præst
efficiency moderates the effect of market attention on new product development. The paper therefore concludes that product innovation and energy efficiency is a balancing act, focusing on one will have detrimental effects on the other! These findings point to the conclusion that researchers and practitioners....... Logistic regression analysis demonstrates that while market attention is important for new product development, green aspects of innovation and efficiency considerations for innovation are important for the energy efficiency of the production companies. Combining these models highlights that energy...... in innovation management have to take the specificities and interactions of different types of eco-innovation more carefully in consideration than so far and to formulate new managerial practices combining energy efficiency and product innovation....
Budden, Philip Marcus.
This thesis is a contemporary history of one episode in the United Kingdom's experience of the European Community (EC). It charts the making of the Single European Act (SEA) from its early 1980s' origins, through the bargaining process of the Dooge Committee and 1985 intergovernmental conference (IGC), to the SEA itself. By studying the origins of a specific treaty, the thesis analyses the impact of EC membership on one west European nation state and places the histor...
Gottlieb, Daniel A; Prince, Emily B
Four conditioned approach experiments with rats assessed for effects of number of acquisition trials on extinction of conditioned responding, when number of acquisition sessions and total acquisition time were held constant. In Experiment 1, 32 trials per acquisition session led to more extinction responding than did 1 or 2 trials per session but less than did 4 trials per session. In Experiment 2, 2 trials per acquisition session led to more spontaneous recovery than did 32 trials per session. These latter findings are reminiscent of the overtraining extinction effect (OEE). Experiment 3 attempted to reduce the OEE with a preconditioning phase of partial reinforcement. Experiment 4 attempted to reduce the beneficial within-subject effects of increasing the number of acquisition trials on extinction observed by Gottlieb and Rescorla (2010) by extinguishing stimuli in different sessions. Overall, results suggest a procedural asymmetry: between-subject, increasing the number of trials between any pair of trials does not lead to greater persistence of responding during extinction; within-subject, it does. Results are discussed from an associative perspective, with a focus on explanations involving either frustration or comparator mechanisms, and from an information processing perspective, with a focus on Rate Estimation Theory. PMID:22475497
noteworthy. Most African trials are externally funded, and it is possible that stricter agency requirements when leading trials in other countries and greater experience and training of principal investigators of an international stature, may account for this difference.
O percurso do "doente oncológico": a (reconceptualização do acto informativo El recorrido del "enfermo oncologico": el (reconceptualismo del acto informativo The experience of the "oncologic patient": (reconceptualizing the informative act
Carlos António Laranjeira
study was to investigate the scientific work published in periodicals indexed by the Medline and Lilacs databases between 1990 and 2006 as to the informative act and the different forms in which information is provided to oncology patients. This analysis of the literature led to the conclusion that there has been an increase in the volume of publications, underlining the role of the oncology patient as a catalyst for new strategies for psychosocial adjustment and revealing her key role through her status as a 'professional patient'.
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Marin dos Santos, Douglas H.; Atallah, Álvaro N.
The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the ...
Tomillero, A; Moral, M A
Gateways to clinical trials is a guide to the most recent trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort
Tomillero, A; Moral, M A
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil
Emery, C. A.; Roos, Ewa M.; Verhagen, E.; Finch, C. F.; Bennell, K. L.; Story, B.; Spindler, K.; Kemp, J.; Lohmander, L. S.
The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for...... will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact....
Schumacher, Michael; Denier, Christian; Oudinet, Jean-Paul; Adams, David; Guennoun, Rachida
Since the first pioneering studies in the 1990s, a large number of experimental animal studies have demonstrated the neuroprotective efficacy of progesterone for brain disorders, including traumatic brain injury (TBI). In addition, this steroid has major assets: it easily crosses the blood-brain-barrier, rapidly diffuses throughout the brain and exerts multiple beneficial effects by acting on many molecular and cellular targets. Moreover, progesterone therapies are well tolerated. Notably, increased brain levels of progesterone are part of endogenous neuroprotective responses to injury. The hormone thus emerged as a particularly promising protective candidate for TBI and stroke patients. The positive outcomes of small Phase 2 trials aimed at testing the safety and potential protective efficacy of progesterone in TBI patients then provided support and guidance for two large, multicenter, randomized and placebo-controlled Phase 3 trials, with more than 2000 TBI patients enrolled. The negative outcomes of both trials, named ProTECT III and SyNAPSE, came as a big disappointment. If these trials were successful, progesterone would have become the first efficient neuroprotective drug for brain-injured patients. Thus, progesterone has joined the numerous neuroprotective candidates that have failed in clinical trials. The aim of this review is a reappraisal of the preclinical animal studies, which provided the proof of concept for the clinical trials, and we critically examine the design of the clinical studies. We made efforts to present a balanced view of the strengths and limitations of the translational studies and of some serious issues with the clinical trials. We place particular emphasis on the translational value of animal studies and the relevance of TBI biomarkers. The probability of failure of ProTECT III and SyNAPSE was very high, and we present them within the broader context of other unsuccessful trials. PMID:26598278
A protocol for a pragmatic randomized controlled trial using the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) platform approach to promote person-focused primary healthcare for older adults
Dolovich, Lisa; Oliver, Doug; Lamarche, Larkin; Agarwal, Gina; Carr, Tracey; Chan, David; Cleghorn, Laura; Griffith, Lauren; Javadi, Dena; Kastner, Monika; Longaphy, Jennifer; Mangin, Dee; Papaioannou, Alexandra; Ploeg, Jenny; Raina, Parminder
Background Healthcare systems are not well designed to help people maintain or improve their health. They are generally not person-focused or well-coordinated. The objective of this study is to evaluate the effectiveness of the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) approach in older adults. The overarching hypothesis is that using the Health TAPESTRY approach to achieve better integration of the health and social care systems into a person’s life t...
Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.
Godyń, Justyna; Jończyk, Jakub; Panek, Dawid; Malawska, Barbara
Alzheimer's disease (AD) is considered to be the most common cause of dementia and is an incurable, progressive neurodegenerative disorder. Current treatment of the disease, essentially symptomatic, is based on three cholinesterase inhibitors and memantine, affecting the glutamatergic system. Since 2003, no new drugs have been approved for treatment of AD. This article presents current directions in the search for novel, potentially effective agents for the treatment of AD, as well as selected promising treatment strategies. These include agents acting upon the beta-amyloid, such as vaccines, antibodies and inhibitors or modulators of γ- and β-secretase; agents directed against the tau protein as well as compounds acting as antagonists of neurotransmitter systems (serotoninergic 5-HT6 and histaminergic H3). Ongoing clinical trials with Aβ antibodies (solanezumab, gantenerumab, crenezumab) seem to be promising, while vaccines against the tau protein (AADvac1 and ACI-35) are now in early-stage trials. Interesting results have also been achieved in trials involving small molecules such as inhibitors of β-secretase (MK-8931, E2609), a combination of 5-HT6 antagonist (idalopirdine) with donepezil, inhibition of advanced glycation end product receptors by azeliragon or modulation of the acetylcholine response of α-7 nicotinic acetylcholine receptors by encenicline. Development of new effective drugs acting upon the central nervous system is usually a difficult and time-consuming process, and in the case of AD to-date clinical trials have had a very high failure rate. Most phase II clinical trials ending with a positive outcome do not succeed in phase III, often due to serious adverse effects or lack of therapeutic efficacy. PMID:26721364
Галина Викторовна Томсон
Full Text Available Teaching language for specific purposes is the basis of the MGIMO Bachelors’ and Masters’ language education. However, it is experts on language and teaching rather than specialists in the sphere of law that are engaged in this work. The author of this article shares her experience of mastering a new specialization and applying her linguistic knowledge to it.It is creating educational resources that requires not only careful selection of authentic texts, defining specialized lexical base, but also viewing these texts as a complex syntactic whole, possessing its own structure and constituting a language unit that can be modeled. Linguistic perception of specialized texts facilitates the creation of practice-oriented educational resources, the application of which results in university graduates’ ability to use the language of their profession properly.The main conclusion from the results presented in this research shows that the dependent clauses act as the limiting ones. This allows you to add unambiguity and clarity to professional language. Simultaneous accesses to the world of reality and the world of language explains its primary role in verbal and cogitative human activity and puts the sentence as the basic unit of speech in the center of the "language - thinking" system, relating thought and language structures in the overall implementation of the communicative function of language.DOI: http://dx.doi.org/10.12731/2218-7405-2013-6-6
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses, which has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the world's first drug discovery and development portal, providing information on study design, treatments, conclusions and references. This issue focuses on the following selection of drugs: Abacavir sulfate; abciximab; abetimus sodium; adalimumab; aldesleukin; almotriptan; alteplase; amisulpride; amitriptyline hydrochloride; amoxicillin trihydrate; atenolol; atorvastatin calcium; atrasentan; Beclometasone dipropionate; bosentan; Captopril; ceftriaxone sodium; cerivastatin sodium; cetirizine hydrochloride; cisplatin; citalopram hydrobromide; Dalteparin sodium; darusentan; desirudin; digoxin; Efalizumab; enoxaparin sodium; ertapenem sodium; esomeprazole magnesium; estradiol; ezetimibe; Famotidine; farglitazar; fluorouracil; fluticasone propionate; fosamprenavir sodium; Glibenclamide; glucosamine sulfate; Heparin sodium; HSPPC-96; hydrochlorothiazide; Imatinib mesilate; implitapide; Lamivudine; lansoprazole; lisinopril; losartan potassium; l-Propionylcarnitine; Melagatran; metformin hydrochloride; methotrexate; methylsulfinylwarfarin; Nateglinide; norethisterone; Olmesartan medoxomil; omalizumab; omapatrilat; omeprazole; oseltamivir phosphate; oxatomide; Pantoprazole; piperacillin sodium; pravastatin sodium; Quetiapine hydrochloride; Rabeprazole sodium; raloxifene hydrochloride; ramosetron hydrochloride; ranolazine; rasburicase; reboxetine mesilate; recombinant somatropin; repaglinide; reteplase; rosiglitazone; rosiglitazone maleate; rosuvastatin calcium; Sertraline; simvastatin; sumatriptan succinate; Tazobactam sodium; tenecteplase; tibolone; tinidazole; tolterodine tartrate; troglitazone; Uniprost; Warfarin sodium; Ximelagatran. PMID:11980386
Heitor de C. Aguiar
efeito residual do fósforo foi enorme, sendo que superfosfato, Serranafosfato e farinha de ossos se mostraram equivalentes e superiores a Cibrafosfato. Estudando conjuntamente os ensaios que entraram neste e no artigo anterior, os autores concluíram que superfosfato se comportou melhor que os outros fosfatos menos solúveis, no que toca ao efeito imediato, e não foi inferior o êles no que toca ao efeito residual.Proceeding with the publication begun in a previous paper, the authors report the results of further experiments designed to test the efficiency of various phosphates for cotton. This second series was conducted between 1941-42 and 1944-45. While one of the six experiments utilized to determine the effects on the yields was annual, the others were conducted in the same plots for two to four seasons. The yearly application of P2O3, 80 kilograms per hectare, was always used in the presence of nitrogen and potash. Except in one of the experiments, where no effect was observed, the responses to phosphorus varied from fair to very high. In the average of the latter five experiments, bone meal and Serranaphosphate gave similar results and were superior to Cibraphosphate, while superphosphate was superior to all of them. As a rule these differences tended to decrease as the number of years of the experiments was increased. In four of the five experiments phosphorus hastened the fruiting march of the cotton plant. In this regard the influence of the various phosphates was similar in two experiments, while in the others, located on soils highly deficient in this nutrient, superphosphate was superior. Generally phosphorus increased the weight of the bolls and seeds, but did not influence the lint percentage and length, even where the effects an the yields were very high. The residual effect of phosphorus, which was studied in two of the experiments, was very high, and even on the "terra-roxa-misturada" soil (one experiment superphosphate, bone meal and Serranaphosphate
Cockayne, Sarah; Hewitt, Catherine; Hashmi, Farina; Hicks, Kate; Concannon, Michael; McIntosh, Caroline; Thomas, Kim; Hall, Jill; Watson, Judith; Torgerson, David; Watt, Ian
Background Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. Meth...
For the first time, a paper delivered at the Annual Nuclear Conference was presented by two authors, the CEO of Bayernwerk AG, Dr. Otto Majewski, and the CEO of the Power Generation Division (KWU) of Siemens AG, Adolf Huettl, reflecting the operators' and the vendors' points of view about the present situation of nuclear power use in Germany and the need to maintain its share in the energy mix. The events associated with shipments of casks for radioactive waste have rekindled the debate about the responsibility of the peaceful use of nuclear power in the nuclear opposition camp. That debate needs to be put back on a factual basis. If no consensus could be achieved now about the use of nuclear power as a whole, at least consensus had to be reached about the future approach to spent fuel and waste management. From the outset, the nuclear industry has shown a high degree of responsibility, developing concepts of using uranium as an energy source in an economically viable and responsible way. It is showing responsibility also in making provision for the future. The safe and economically successful operation of today's nuclear power plants is an important reason for developing new reactor concepts. That development of new rector lines depends critically on the preservation and advancement of specialized knowledge. Know-how needs to be preserved and developed further not only for future nuclear power plants but also for the plants existing now, which still have service lives of several decades. Sustainable energy supply requires all sources of energy to be exploited, especially those which do not generate carbon dioxide. All the options currently known must be kept open and preserved, respectively, for coming generations. Acting responsibly means adding to the choices available. (orig.)
Right to life -as the prohibition of intentionally and arbitrarily taking life, even with authorization of the concerned one- is an internationally recognized right. In many countries, debate regarding euthanasia is more centered in its convenience, social acceptability and how it is regulated, than in its substantial legitimacy. Some argue that euthanasia should be included as part of clinical practice of health professionals, grounded on individual's autonomy claims-everyone having the liberty to choose how to live and how to die. Against this, others sustain that life has a higher value than autonomy, exercising autonomy without respecting the right to life would become a serious moral and social problem. Likewise, euthanasia supporters some-times claim a 'right to live with dignity', which must be understood as a personal obligation, referred more to the ethical than to the strictly legal sphere. In countries where it is already legalized, euthanasia practice has extended to cases where it is not the patient who requests this but the family or some healthcare professional, or even the legal system-when they think that the patient is living in a condition which is not worthy to live. Generalization of euthanasia possibly will end in affecting those who need more care, such as elder, chronically ill or dying people, damaging severely personal basic rights. Nature, purpose and tradition of medicine rule out the practice of euthanasia, which ought not be considered a medical act or legitimately compulsory for physicians. Today's medicine counts with effective treatments for pain and suffering, such as palliative care, including sedative therapy, which best preserves persons dignity and keeps safe the ethos of the medical profession. PMID:22051717
The Price-Anderson Act establishes nuclear liability law in the United States. First passed in 1957, it has influenced other nuclear liability legislation around the world. The insurer response the nuclear accident at Three Mile Island in 1979 demonstrates the application of the Act in a real life situation. The Price-Anderson Act is scheduled to be renewed in 2002, and the future use of commercial nuclear power in tge United States will be influenced by this renewal. (author)
Ross, Joseph S.; Mulvey, Gregory K.; Hines, Elizabeth M.; Nissen, Steven E.; Krumholz, Harlan M.
Editors' Summary Background People assume that whenever they are ill, health care professionals will make sure they get the best available treatment. But how do clinicians know which treatment is most appropriate? In the past, clinicians used their own experience to make treatment decisions. Nowadays, they rely on evidence-based medicine—the systematic review and appraisal of the results of clinical trials, studies that investigate the efficacy and safety of medical interventions in people. H...
Ross, Joseph S.; Mulvey, Gregory K.; Hines, Elizabeth M.; Steven E. Nissen; Krumholz, Harlan M.
Editors' Summary Background People assume that whenever they are ill, health care professionals will make sure they get the best available treatment. But how do clinicians know which treatment is most appropriate? In the past, clinicians used their own experience to make treatment decisions. Nowadays, they rely on evidence-based medicine—the systematic review and appraisal of the results of clinical trials, studies that investigate the efficacy and safety of medical interventions in people. H...
Gluud, C; Sørensen, T I
The urgent need for the performance of more, better designed, and better conducted randomised clinical trials is increasingly recognised. Based on structured interviews with leading persons of 43 outstanding organisations and units involved in clinical trials in Europe and North America during 1993......, ways of organising and staffing clinical trial units were investigated. The present proposal is based on this experience from which an attempt to extract a composite set of minimal requirements has been made regarding pertinent objectives and aims, organisational aspects, staffing, and estimated costs...... of establishing a clinical trial unit. The core staff is suggested to consist of two chief physicians, one statistician, one data manager, one project coordinator, and two secretaries. In order to fulfil the minimal requirements for running such a unit, it is calculated that about GBP 450,000 per year is needed...
Last year's report summarized the status of both the long on-going soil and plant sampling programs (initiated by LLNL in 1978) and the field experiments aimed at reducing radionuclide levels in food plants to acceptable levels. In the current report the two are combined into a single summary table, indicating for each field trial or survey the results to date, information expected by the spring of 1988, and projection, if any, for continuation beyond FY1988. This table is therefore a comprehensive survey of the program and accordingly the individual items in it have been coded to facilitate reference to them. Analytical results from field studies installed in 1985 and 1986 are now providing much new information, briefly described below. In part, these results bear out or enlarge the hypotheses that prompted the studies. They also suggest how some treatments may be modified or combined for greater effectiveness. We shall discuss here certain groups of studies of immediate interest that deal with the blocking effects of potassium and other ions on cesium-137 uptake by plants, the effect of removing topsoil (excavation), cultural studies which involve the manipulation of the subsoil, plus some others
This Act provides for the transfer of property, rights, liabilities and obligations of parts of the undertaking of the United Kingdom Atomic Energy Autority, to two new Compagnies set up for this purpose: the Bristish Nuclear Fuels Limited, and the Radiochemical Centre Limited. Patents licences and registered designs owned by the Autority at the time of the transfer are not included therein. The Act also includes amendments to the Nuclear Installations Act 1965, notably as regards permits to operate granted to a body corporate. Finally, the Schedule to this Act lays down a certain number of provisions relating to security and the preservation of secrets. (NEA)
Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse;
BACKGROUND: Cognitive deficits are a distinct feature among people at ultra-high risk (UHR) for psychosis and pose a barrier to functional recovery. Insufficient evidence exists on how to ameliorate these cognitive deficits in patients at UHR for psychosis and hence improve daily living and quality...... the cognitive training to their everyday lives. Follow-up assessments will be conducted at 6 and 12 months after randomisation. The primary outcome is the composite score on the Brief Assessment of Cognition in Schizophrenia at cessation of treatment after 6 months. Secondary outcomes are social and......-blinded clinical trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard...
Scheinberg, Morton; de Melo, Flavio Fernando Nogueira; Bueno, Adrian Nogueira; Costa, Carolyne Mendes; de Azevedo Bahr, Maria Lucia Alvares; Reis, Enio Ribeiro
The objective of the study was to evaluate prospectively real-life experience on the effect of belimumab on patients with active systemic lupus erythematosus (SLE). Forty-eight patients with active SLE were evaluated after 1 year of continuous treatment. Thirty-eight patients were still on treatment at the end of 1 year, and it was possible to observe significant clinical improvement in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score with a decrease from 12 ± 3.0 to 2.5 ± 2.5, also a decrease on the daily steroid dose from 30 ± 12.5 to 7.5 ± 5.0 mg and partial improvement on serology. Belimumab treatment is associated with real benefit in the majority of patients that maintain active disease in spite of continuing on standard of care. PMID:27106543
Lee Su Jin
Full Text Available Abstract Background In the past few years, the number of clinical trials has increased rapidly in East Asia, especially for gastric and hepatobiliary cancer that are prevalent in Asian populations. However, the actual degree of understanding or perceptions of clinical trials by cancer patients in East Asian countries have seldom been studied. Methods Between July 1st and November 30th of 2011, we conducted a prospective study to survey cancer patients regarding their awareness of, and willingness to participate in, a clinical trial. Patients with gastrointestinal/hepatobiliary cancer who visited the Hematology-Oncology outpatient clinic at Samsung Medical Center (SMC were enrolled. A total of 21 questions were asked including four questions which used the Visual analogue scale (VAS score. Results In this survey study, 1,000 patients were asked to participate and 675 patients consented to participate (67.5%. The awareness of clinical trials was substantially higher in patients who had a higher level of education (pp=0.004, and had a higher economic status (p=0.001. However, the willingness to participate in a clinical trial was not affected by the level of education or economic status of patients. The most influential factors for patient willingness to participate were a physician recommendation (n=181, 26.8%, limited treatment options (n=178, 26.4%, and expectations of effectiveness of new anti-cancer drugs (n=142, 21.0%. Patients with previous experience in clinical trials had a greater willingness to participate in clinical trials compared to patients without previous experience (p Conclusions This large patient cohort survey study showed that Korean cancer patients are more aware of clinical trials, but awareness did not translate into willingness to participate.
Feathers, Alexandra; Aycinena, Ana C.; Lovasi, Gina S.; Rundle, Andrew; Gaffney, Ann Ogden; Richardson, John; Hershman, Dawn; Koch, Pam; Contento, Isobel; Greenlee, Heather
Few studies have examined the built environment's role in recruitment to and adherence in dietary intervention trials. Using data from a randomized dietary modification trial of urban Latina breast cancer survivors, we tested the hypotheses that neighborhood produce access could act as a potential barrier and/or facilitator to recruitment, and that a participant's produce availability would be associated with increased fruit/vegetable intake, one of the intervention's targets. Eligible women ...
Lynch, Kevin G; Cary, Mark; Gallop, Robert; Ten Have, Thomas R
In the context of randomized intervention trials, we describe causal methods for analyzing how post-randomization factors constitute the process through which randomized baseline interventions act on outcomes. Traditionally, such mediation analyses have been undertaken with great caution, because they assume that the mediating factor is also randomly assigned to individuals in addition to the randomized baseline intervention (i.e., sequential ignorability). Because the mediating factors are typically not randomized, such analyses are unprotected from unmeasured confounders that may lead to biased inference. We review several causal approaches that attempt to reduce such bias without assuming that the mediating factor is randomized. However, these causal approaches require certain interaction assumptions that may be assessed if there is enough treatment heterogeneity with respect to the mediator. We describe available estimation procedures in the context of several examples from the literature and provide resources for software code. PMID:19484136
Martin, Ralph C., II; Keeley, Elizabeth
Reviews the protections afforded by the Constitution for defendants in criminal trials. These include the right to a jury trial (in cases of possible incarceration), an impartial jury, and the requirement of a unanimous verdict. Defends the use of plea bargaining as essential to an efficient criminal justice system. (MJP)
Kjaergard, L L; Nikolova, D; Gluud, C
Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...
B.A. Kirwan (Bridget Anne)
textabstractThe aim of this thesis is to show how clinical trial conduct can be managed while respecting the underlying scientific principles. Chapter 2 describes the main results of PICO (PImobendan in COngestive heart failure), a trial which investigated a positive inotropic agent in patients with
Full Text Available The term "prehypertension" defined as systolic blood pressure between 120 and 139 mmHg and/or diastolic pressures between 80 and 89 mmHg has now gained general acceptance. Prehypertension is associated with ~3-fold greater likelihood of developing hypertension, and roughly twice the number of cardiovascular events, than BP < 120/80 mmHg. When compared with normotensive individuals, prehypertensive individuals are more likely to be overweight and obese, to have other cardiovascular risk factors, to progress to established hypertension, and to experience premature clinical cardiovascular disease. The major unresolved issue is the appropriate manage-ment of such patients. Lifestyle modification is recommended for all patients with prehypertension as it effectively reduces rate of cardiovascular events. Presently pharmacological therapy is indicated for some patients with prehypertension who have specific comorbidities, including diabetes mellitus, chronic kidney disease, and coronary artery disease.
Though the Nuremberg medical trial was a United States military tribunal, British forensic pathologists supplied extensive evidence for the trial. The BMJ had a correspondent at the trial, and he endorsed a utilitarian legitimation of clinical experiments, justifying the medical research carried out under Nazism as of long term scientific benefit despite the human costs. The British supported an international medical commission to evaluate the ethics and scientific quality of German research....
Fransen, G.A.J.; Marrewijk, C.J. van; Mujakovic, S.; Muris, J.W.M.; Laheij, R.J.F.; Numans, M.E.; de Wit, N J; Samsom, M; Jansen, J. B. M. J.; Knottnerus, J A
BACKGROUND: Pragmatic randomised controlled trials are often used in primary care to evaluate the effect of a treatment strategy. In these trials it is difficult to achieve both high internal validity and high generalisability. This article will discuss several methodological challenges in designing and conducting a pragmatic primary care based randomised controlled trial, based on our experiences in the DIAMOND-study and will discuss the rationale behind the choices we made. From the success...
Innovative anti-HIV drugs developed by local sponsors in China have come into the stage of early-phase clinical trials.How to systemically design the clinical trials of innovative anti-HIV drugs still remains a challenge for them.This article references the literature and the experience of reviewers,to introduce general considerations concerning early-phase clinical trials of innovative anti-HIV drugs.
LI YaJie; ZHAO Ming; ZHAO DeHeng
Innovative anti-HIV drugs developed by local sponsors in China have come into the stage of early-phase clinical trials. How to systemically design the clinical trials of innovative anti-HIV drugs still remains a challenge for them. This article references the literature and the experience of reviewers, to introduce general considerations concerning early-phase clinical trials of innovative anti-HIV drugs.
Marta Teixeira; Gabriel Pires; Miguel Raimundo; Sérgio Nascimento; Vasco Almeida; Miguel Castelo-Branco
The neural correlates of visual awareness are elusive because of its fleeting nature. Here we have addressed this issue by using single trial statistical ‘‘brain reading’’ of neurophysiological event related (ERP) signatures of conscious perception of visual attributes with different levels of saliency. Behavioral reports were taken at every trial in 4 experiments addressing conscious access to color, luminance, and local phase offset cues. We found that single trial neurophysiologic...
O. S. Neves
ensaios em que os dois últimos métodos foram estudados não permitiram tirar conclusões definitivas sôbre o mais eficiente para a produção. Entretanto, tendo-se em vista inconvenientes que se opõem à aplicação antecipada, e, por outro lado, fatôres que militam a favor da aplicação lateral, parece que esta é a mais apropriada para se conseguir das tortas - e de vários outros adubos - muito melhores resultados que os obtidos pelo método usual. Sugere-se, por isso, que se continui a experimentá-la com as modificações apresentadas.In this paper are reported the results of 37 experiments - six repeated in the same plots for two or three consecutive years - designed to study the effect of castor pomace and cottonseed meal as fertilizers for the cotton crop. In these experiments, conducted between 1937 and 1945 and located at eleven different sites comprising the main soil types of the Planalto Paulista, were compared sources of nitrogen (castor pomace, Chilean nitrate, ammonium sulphate etc., increasing rates of application of cottonseed meal, and methods of application of cottonseed meal. Applied by the usual method, consisting in the addition of the fertilizer to the seed furrow and mixing it with the soil just before planting, castor pomace and cottonseed meal generally gave poor results; in a few cases only were obtained satisfactory responses, but in several others they did not increase or even depressed the yield. This was observed in the absence as well as in the presence of phosphorus and potassium fertilizers. Rates of 600 and 800 kilograms of cottonseed meal per hectare generally gave no better results than 400 kilograms. Castor pomace was inferior to the soluble nitrogenous fertilizers used. The poor performance of the organic fertilizers is attributed principally to the serious injury they caused to the germinating seed and the little efficiency of the subsequent replanting of the missing hills. The method of application used in the experiments
... of Information Act of 1966, as amended, 5 U.S.C. 552, and the Federal Election Campaign Act (``FECA... the Sunshine Act, Freedom of Information Act (``FOIA''), and Federal Election Campaign Act (``FECA... word ``meeting.'' Corrections to Freedom of Information Act Rules in Part 4 of Title 11 of the Code...
The main purpose of this Act is to enable the United Kingdom to ratify the Convention on the Physical Protection of Nuclear Material which opened for signature at Vienne and New York on 3 March 1980. The Act extends throughout the United Kingdom. (NEA)
This article compares essays written in response to the ACT Essay prompt and a locally developed prompt used for placement. The two writing situations differ by time and genre: the ACT Essay is timed and argumentative; the locally developed is untimed and explanatory. The article analyzes the differences in student performance and predictive…
The Freedom of Information Act amendments, which became effective in February 1975, have so far yielded mixed results. This report provides an account of how different federal agencies are implementing this amended statute. Among the topics discussed are modifications of the original 1966 Freedom of Information Act, which were made in the attempt…
... From the Federal Register Online via the Government Publishing Office CENTRAL INTELLIGENCE AGENCY 32 CFR Part 1901 Privacy Act AGENCY: Central Intelligence Agency. ACTION: Proposed rule. SUMMARY: Consistent with the Privacy Act (PA), the Central Intelligence Agency (CIA) has undertaken and completed...
Promulgated in 1963, the Atomic Energy Commission Act (204) established and vested in the Ghana Atomic Energy Commission the sole responsibility for all matters relating to the peaceful uses of atomic energy in the country. Embodied in the Act are provisions relating to the powers, duties, rights and liabilities of the Commission. (EAA)
Full Text Available ... years of experiments in the laboratory and in animals before they even consider testing an experimental treatment in people. Most of this early research occurs at universities and medical centers across the country. The National Institutes of ...
... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment in people. Most of this early research occurs at universities and medical centers across the ...
Full Text Available ... the best treatment for a disease evaluate treatment methods such as surgical techniques, psychiatric therapy, or radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory ...
Full Text Available ... for more information Scientists usually do years of experiments in the laboratory and in animals before they ... of caregivers, support groups, and various types of social interventions. Supportive care interventions are not intended to ...
Full Text Available ... years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ... gathers more information about safety and effectiveness, studying different populations and different dosages and using the drug ...
Full Text Available ... evaluate treatment methods such as surgical techniques, psychiatric therapy, or radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ...
Full Text Available ... years of experiments in the laboratory and in animals before they even consider testing an experimental treatment in people. Most of this early research occurs at universities and medical centers across the ...
Full Text Available ... a disease evaluate treatment methods such as surgical techniques, psychiatric therapy, or radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory ...
results obtained in eight experiments carried out from 1949-50 to 1954-55, in which superphosphate was compared with Hyperphosphate and Serrote-phosphate (ground rock phosphates on the basis of 0, 40 and 80 kilograms of P2O5 to the hectare in the presence of nitrogen and potash. The experiments were conducted for 2-5 yeors in the same plots and located on different soil types of the Planalto Paulista. In the overage of the six experiments located on soil which responded to phosphorus, with the 40-kilogram rate of application the yield increases due to Hyperphosphate and Serrote-phosphote were respectively half and one fourth of that caused by superphosphate; with the 80-kilogram rate, however, the response to Hyperphosphate was a little superior and that of Serrote-phosphate about equal to half the effect of superphosphate. The relative responses to the three phosphates were practically equal in the various soil types, but they changed appreciably in the course of the experiments. In the first year, while superphosphate increased considerably the yields, the responses to the other phosphates were very poor, even when they were applied at the 80-kilogram rate. However, starting from the second or third year the effects of the two rates of Hyperphosphate were a little superior to half the effects of the corresponding doses of superphosphate. Regarding Serrote-phosphate, at the 40-kilogram rate its effect was always very poor, but with the double rate it proved about half as efficient as superphosphate with the same amount of phosphorus.
The present study investigated the co-ordination between architecture configuration and the physiological systems of rats. The architectural design of a room may create a new media that affect the physical and psychological structure of the bodies through specific fractional and frequency specific effects. In order to test this hypothesis we designed a pilot experiment to explore the energy radiation of the biological systems due to variation of room shape. We examined 6 differently shaped room model designs on 6 sets of rats (as an animal model) that where housed in different rooms (8 rats per cage) for a period of 12 weeks. Plus maze test for measuring some behavior changes was used and showed that the hexagonal shape causes balance in central nervous system. Biochemical analysis showed that liver enzyme GOT was decreased in hexagonal and circle shapes, while increased in square shape. On the other hand, GPT was decreased in triangle shape while there no change in other shapes. Thyroid hormones T3 and T4 were decreased in hexagonal shape while T3, increased in circle shape. RBCs and WBCs were decreased in hexagonal shape, while the pentagonal shape caused decrease in WBCs. The cholesterol content was decreased in hexagonal shape. It could be concluded that the living in hexagonal shape making balance between different organs of the body. Explanation of results are given with reference to biological resonance and Human 'Energy centers' (Charkas)
Tip O'Neill, one of the grand old men of modem US politics, once famously remarked that all politics is local. Like most politicians who succeed on the national stage - and not just in the US - it was a truth he never lost sight of. What is true for politicians is equally true in the communications business. We may increasingly live in a global village, but successful companies - even multi-nationals - forget the importance of local and regional public relations at their peril. Think of Douglas Ivester, the CEO of Coca-Cola at the time of the 1999 Belgian contamination scandal, who allegedly reacted to first reports of the crisis by asking: 'Where the hell is Belgium?' A more appropriate question today - several years after Coke's share price toppled and the CEO was unceremoniously sacked - might be: 'Who the hell is Douglas Nester?' But - to adapt another famous phrase - the fact that communications (and marketing) professionals still need to 'act local' as much as ever before should not blind us to the growing need to 'think global'. In the nuclear industry, as in the world economy generally, increasing global integration is a reality, as are the international nature of the news media and the increasingly global nature of the anti-nuclear pressure groups. Indeed, it was the growing need for a truly global information network to counter these trends, by increasing the overall speed and accuracy of the worldwide nuclear information flow, that led the nuclear community to establish NucNet in 1991. So where exactly is the line between local and regional nuclear communications on the one hand, and global communications on the other? Is there one spin for a regional audience, and another for a global audience? This presentation proposes some guiding principles, by examining the response of nuclear communicators world-wide to the new communications agenda imposed in the wake of the September 11th suicide attacks in the US. NucNet President Doug McRoberts and Executive
Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |
Boutrup, Torsten Snogdal; Fry, Christian
getting experiences in this context, but also to use the fish for performing diagnostic procedures from clinical cases, and to collect positive tissue material from infected fish. We performed a pre-trial with three different species of gourami’s: three spot gourami, pearl gourami and dwarf gourami. Each...... choice, to include as positive control of the pathogenicity of injected spores. Secondly we set up a confirmatory trial in three spotted gouramis, here it was also seen that around a third of the fish got clinically diseased. From these and later trials it is our experience that using A. invadans grown...... website. The pictures will show different types of lesions using standard H&E stain and special stains, explanatory text will follow each picture. First we will upload tissue from infected Gouramis, following this; pictures of lesions in rainbow trout....
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abiraterone acetate, acyline, adalimumab, adenosine triphosphate, AEE-788, AIDSVAX gp120 B/B, AK-602, alefacept, alemtuzumab, alendronic acid sodium salt, alicaforsen sodium, alprazolam, amdoxovir, AMG-162, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, aminophylline hydrate, anakinra, anecortave acetate, anti-CTLA-4 MAb, APC-8015, aripiprazole, aspirin, atazanavir sulfate, atomoxetine hydrochloride, atorvastatin calcium, atrasentan, AVE-5883, AZD-2171; Betamethasone dipropionate, bevacizumab, bimatoprost, biphasic human insulin (prb), bortezomib, BR-A-657, BRL-55730, budesonide, busulfan; Calcipotriol, calcipotriol/betamethasone dipropionate, calcium folinate, capecitabine, capravirine, carmustine, caspofungin acetate, cefdinir, certolizumab pegol, CG-53135, chlorambucil, ciclesonide, ciclosporin, cisplatin, clofarabine, clopidogrel hydrogensulfate, clozapine, co-trimoxazole, CP-122721, creatine, CY-2301, cyclophosphamide, cypher, cytarabine, cytolin; D0401, darbepoetin alfa, darifenacin hydrobromide, DASB, desipramine hydrochloride, desloratadine, desvenlafaxine succinate, dexamethasone, didanosine, diquafosol tetrasodium, docetaxel, doxorubicin hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecallantide, efalizumab, efavirenz, eletriptan, emtricitabine, enfuvirtide, enoxaparin sodium, estramustine phosphate sodium, etanercept, ethinylestradiol, etonogestrel, etonogestrel/ethinylestradiol, etoposide, exenatide; Famciclovir, fampridine, febuxostat, filgrastim, fludarabine phosphate, fluocinolone acetonide, fluorouracil, fluticasone propionate
Harrison, D.A. [British Steel plc, Scunthorpe (United Kingdom)
The six coke oven authorizations now in force in British Steel were issued during the summer of 1993. The paper outlines the four major duties of the operator set out in the authorization document which refer to good maintenance of equipment and management of personnel, sampling and monitoring procedures, maintaining records and notification of any contravention of the authorised conditions. Part 5 of the authorization concerns the improvement programme. Several improvements common at British Steel sites concerning pollution monitoring and control are listed. 5 figs.
Innovation and knowledge management are central questions of the modern world economy where the incorporation of new knowledge is determining for competition. In this context, there is a movement of pression under public research institutions for a more dynamic participation on the local innovation system. The institutions of C and T should prepare to help the companies to insert in the context of open economies and also to compete in the global market. The modernity requires flexibility and organizational changes in the research institutions. Redefinitions of their practices in relation to other aspects such as: financing sources; partnership with other organizations; definition and planning of the objectives; evaluation, diffusion and valorization of the results and the establishing of a measuring system and performance indicators. Aiming at having an effective institutional insertion on the national and regional systems of innovation, the Nuclear Technology Development Center - CDTN reformulated its strategical planning, incorporating the view of the researchers of the Center and external experts. As part of the evaluation process, CDTN organizes an annual seminar for evaluating its projects, focused on presenting the results and also on the analysis of the performance indicators. The result of this pairs review are widely informed to the Institution and is an important tool for the critical analysis of the institutional performance and for corrections to be made by the high direction. This paper presents the methodology for evaluating the results, as well as the difficulties and improvements incorporated to the process, which has been applied for three years. (author)
Lindquist, Kristen A; Barrett, Lisa Feldman
This study examined the hypothesis that emotion is a psychological event constructed from the more basic elements of core affect and conceptual knowledge. Participants were primed with conceptual knowledge of fear, conceptual knowledge of anger, or a neutral prime and then proceeded through an affect-induction procedure designed to induce unpleasant, high-arousal affect or a neutral affective state. As predicted, only those individuals for whom conceptual knowledge of fear had been primed exp...
Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a
Thompson, Michael A
Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape. PMID:24857086
Farmer, Kevin; Meisel, Steven I.; Seltzer, Joe; Kane, Kathleen
The Mock Trial is an experiential exercise adapted from a law school process that encourages students to think critically about theories, topics, and the practice of management in an innovative classroom experience. Playing the role of attorneys and witnesses, learners ask questions and challenge assumptions by playing roles in a trial with…
Lim, Yun Ping; Hoog, Jan-Olov; Gardner, Phyllis; Ranganathan, Shoba; Andersson, Siv; Subbiah, Subramanian; Tan, Tin Wee; Hide, Winston; Weiss, Anthony S.
The S-Star Trial Bioinformatics on-line course (www.s-star.org) is a global experiment in bioinformatics distance education. Six universities from five continents have participated in this project. One hundred and fifty students participated in the first trial course of which 96 followed through the entire course and 70 fulfilled the overall…
The problem of evil has vexed philosophers and theologians for centuries and anthropologists, sociologists, psychoanalysts and analytical psychologists in more recent times. Numerous theories have been proposed but there is still little agreement on such basic questions as the nature of evil, what constitutes and motivates an evil act, and how we resolve conflicts between individuals and groups in which evil acts are being committed. I am proposing that evil should be used as an adjective, and not as a noun. As such it should be employed to qualify acts of persons rather than their character. This change would enable us to eschew foundational explanations of evil and, therefore, to examine evil acts in their contexts and so better discern their nature and motivation. I will contend that evil acts begin when an individual makes, or members of a group make, assertions about the 'naturalness' of their own acts and, correspondingly, the 'unnaturalness' of the acts of others. I will suggest that this results from the anxiety that ensues when they cannot adequately signify their experience of these acts. When this occurs, those so treated are dispossessed of their 'personhood', allowing members of the 'natural' group to violate their 'boundaries' with impunity. These violations can range from the relatively innocuous such as being ignored to the extreme such as genocide. I am asserting that all these acts should be termed evil as they derive from the same semiotic process of 'naturalizaton'. I will discuss ways of preventing individuals or groups from embarking on the process of 'naturalization' and describe the types of contexts that might reduce or eliminate the commission of evil acts by those already engaged in their perpetration. To demonstrate these ideas I will use examples from my personal experience, from analytic theory and from the 'troubles' in Northern Ireland. PMID:19012585
Ayres, Thomas R.
The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)
Hounsgaard, Lise; Hansen, J. P.; Østergaard, B.;
BACKGROUND: Cognitive adaptation training (CAT) targets the adaptive behaviour of patients with schizophrenia and has shown promising results regarding the social aspects of psychosocial treatment. As yet, no reports have appeared on the use of CAT in combination with assertive community treatment...... (ACT). Our purpose was to evaluate the effect of CAT in comparison with ACT, focusing on social functions (primary outcome), symptoms, relapse, re-hospitalisation, and quality of life of outpatients with schizophrenia. METHODS: The trial was a parallel, randomised, multicentre trial conducted in three...... centres treating patients with a first episode of schizophrenia disorder. A total of 62 outpatients diagnosed as having schizophrenia were randomly assigned to CAT+ACT or ACT alone. The CAT was conducted in the patient's home and included instruction in prompting for specific actions. The treatment lasted...
Herr, Harry W
In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial. PMID:16144669
Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten;
with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...
Schroll, Jeppe Bennekou; Maund, Emma; Gøtzsche, Peter C
Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation...
Thomson, NC; Rubin, AS; Niven, RM; Corris, PA; Siersted, HC; Olivenstein, R.; Pavord, ID; McCormack, D.; Laviolette, M.; Shargill, NS; Cox, G.
BACKGROUND: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. METHODS: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial...
Thomson, N C; Rubin, A.S.; Niven, R. M.; Corris, P A; Siersted, H. C.; Olivenstein, R.; Pavord, I.D.; McCormick, D.; Laviolette, M.; Shargill, N.S.; Cox, G.
Background: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. Methods: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. ...
Hallnäs, Lars; Redström, Johan
Interaction Design: Foundations, Experiments is the result of a series of projects, experiments and curricula aimed at investigating the foundations of interaction design in particular and design research in general. The first part of the book - Foundations - deals with foundational theoretical issues in interaction design. An analysis of two categorical mistakes -the empirical and interactive fallacies- forms a background to a discussion of interaction design as act design and of computa...
Cherry, Todd L.; Kallbekken, Steffen; Kroll, Stephen
This paper examines the political difficulty of enacting welfare-enhancing Pigouvian taxes. Using referenda in a market experiment with externalities, we investigate the effect of trial periods on the acceptability of two theoretically equivalent variants of Pigouvian taxes. While implementing either tax is in subjects material self-interest, we find significant levels of opposition to both tax schemes, though the level differs considerably. Results show that trial runs can overcome initial tax aversion, significantly increasing acceptability. The effect is robust across tax schemes, but a trial with one scheme does not affect the acceptability of the other. Trial periods also mitigate initial biases in preferences of alternative tax schemes. (auth)
Full Text Available ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment in people. Most of this early research occurs at universities and medical centers across the ...
Smed, Marie; Getz, Kenneth A
Knowledge generated by site representatives through their participation in clinical trials is valuable for testing new products in use and obtaining final market approval. The leverage of this important knowledge is however challenged as the former direct relationships between in-house staff in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract Research Organization) and thereby adding another link in the relationships between site and sponsor. These changes are intended to optimize the time-consuming and costly trial phases; however, there is a need to study whether valuable knowledge and experience is compromised in the process. Limited research exists on the full range of clinical practice insights obtained by investigators during and after clinical trials and how well these insights are transferred to study sponsors. This study explores the important knowledge-transfer processes between sites and sponsors and to what extent sites' knowledge gained in clinical trials is utilized by the industry. Responses from 451 global investigative site representatives are included in the study. The analysis of the extensive dataset reveals that the current processes of collaboration between sites and the industry restrict the leverage of valuable knowledge gained by physicians in the process of clinical trials. These restrictions to knowledge-transfer between site and sponsor are further challenged if CRO partners are integrated in the trial process. PMID:23454567
... From the Federal Register Online via the Government Publishing Office OVERSEAS PRIVATE INVESTMENT CORPORATION 22 CFR Part 707 Privacy Act AGENCY: Overseas Private Investment Corporation. ACTION: Notice of proposed rulemaking. SUMMARY: This rule proposes revisions to the Overseas Private Investment...
National Oceanic and Atmospheric Administration, Department of Commerce — Critical habitat (CH) is designated for the survival and recovery of species listed as threatened or endangered under the Endangered Species Act (ESA). Critical...
Stephan S Terblanche
Full Text Available In this contribution a number of procedural issues related to the sentencing of child offenders and emanating from the Child Justice Act 75 of 2008 are considered in some detail. As a general rule, the Act requires pre-sentence reports to be obtained from probation officers before sentencing any child offender, with only a limited number of exceptions. The article argues that the peremptory nature of the Act means that a probation report is always required, even if reports by other experts are also available. The exceptions are limited to instances other than those where the child offender is sentenced to any form of imprisonment or to residence in a care centre. The article addresses the question of whether or not the reference to imprisonment includes alternative imprisonment which is imposed only as an alternative to a fine. It suggests that alternative imprisonment should, generally, not be imposed on child offenders. When an exception is not prevented because of the sentence, a pre-sentence report may be dispensed with only when the offence is a schedule-1 offence (the least serious class of offences or when obtaining a report would prejudice the child. It is argued that these exceptions are likely to occur rather rarely. A final aspect of the Act’s provisions on pre-sentence reports is the requirement that reasons be given for a departure from the recommendations in a pre-sentence report. This requirement merely confirms the status quo.The Act permits the prosecutor to provide the court with a victim impact statement. Such a statement is defined in the Act. It is a sworn statement by a victim or someone authorised by the victim explaining the consequences to the victim of the commission of the crime. The article also addresses the issue of whether or not the child justice court might mero motu obtain a victim impact statement when the prosecution does not do so.Finally, the article addresses appeals against and reviews of the trial
Full Text Available In the Netherlands, criteria have been set for field trials with genetically modified (GM plants. These criteria are based on the step-by-step principle as described in European Directive 2001/18/EC. Three categories of field trials are defined. The first category concerns small-scale field trials with GM plants that are not well characterised on the molecular and phenotypic level. Confinement measures are applied in order to limit potential adverse effects to the field location. The second category consists of small-scale field experiments with GM plants that are better characterized. Confinement measures are no longer necessary since sufficient information is available to assess potential adverse effects on human health and the environment for these trials. The third category consists of large-scale field trials with fully characterised GM plants and without the need of confinement measures. For each category, a new permit is required. This system has been used for several crops, including apple and poplar trees and may also be applicable for trials with GM forest trees.
The National Lung Screening Trial (NLST), a research study sponsored by the National Cancer Institute that used low-dose helical CT scans or chest X-ray to screen men and women at risk for lung cancer.
A collection of material about the ALCHEMIST lung cancer trial that will examine tumor tissue from patients with early-stage, completely resected lung cancer for gene mutations in the EGFR and ALK genes, and a
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The Healing Arts Radiation Protection Act is concerned with regulating the registration, installation, operation, inspection and safety of X-ray machines. The Act provides for the establishment of the Healing Arts Radiation Protection Commission which is responsible for reporting on all the above matters to the Ontario Minister of Health. In addition the board is responsible for the continuing development of an X-ray safety code and for the submission of an annual report of their activities to the minister
Jim Hansen, a climatologist at NASA's Goddard Space Institute, is convinced that the earth's temperature is rising and places the blame on the buildup of greenhouse gases in the atmosphere. Unconvinced, John Sununu, former White House chief of staff, doubts that the warming will be great enough to produce serious threat and fears that measures to reduce the emissions would throw a wrench into the gears that drive the Unites States' troubled economy. During his three years at the White House, Sununu's view prevailed, and although his role in the debate has diminished, others continue to cast doubt on the reality of global warming. A new lobbying group called the Climate Council has been created to do just this. Burning fossil fuels is not the only problem; a fifth of emissions of carbon dioxide now come from clearing and burning forests. Scientists are also tracking a host of other greenhouse gases that emanate from a variety of human activities; the warming effect of methane, chlorofluorocarbons and nitrous oxide combined equals that of carbon dioxide. Although the current warming from these gases may be difficult to detect against the background noise of natural climate variation, most climatologists are certain that as the gases continue to accumulate, increases in the earth's temperature will become evident even to skeptics. If the reality of global warming were put on trial, each side would have trouble making its case. Jim Hansen's side could not prove beyond a reasonable doubt that carbon dioxide and other greenhouse gases have warmed the planet. But neither could John Sununu's side prove beyond a reasonable doubt that the warming expected from greenhouse gases has not occurred. To see why each side would have difficulty proving its case, this article reviews the arguments that might be presented in such a hearing
A. Paes de Camargo
Full Text Available Neste artigo são relatadas nove experiências sôbre a localização de adubos na cultura de batata-doce, realizadas entre 1943-44 e 1946-47, sendo quatro com NPK (60-100-40 kg/ha de N-P2O5-K2O e cinco com estêrco. Em dois dos ensaios com NPK, conduzidos em Tupi Paulista (um dêles repetido por três anos no mesmo local, a adubação foi mais eficiente quando misturada com a terra dos camalhões do que aplicada sob eles ou em sulcos feitos em seus cumes. Nos outros dois, realizados em Campinas, a aplicação sob os camalhões se mostrou melhor, em média, mas os resultados variaram muito. Tratando-se de assunto que depende de muitos fatôres, inclusive das condições meteorológicas, os autores encarecem a necessidade de se continuarem as experiências, e, tendo discutido as vantagens e desvantagens dos métodos estudados, sugerem a inclusão, em futuros planos, do aplicação de P e K em sulcos laterais às mudas e de N em cobertura. Nas cinco experiências com estêrco, tôdas anuais e executadas em três localidades, seu espalhamento entre os camalhões se mostrou, em regra, inferior à aplicação sob os camalhões ou de mistura com o solo dêstes. Dos dois últimos métodos, o primeiro foi superior em três ensaios, igual em um e inferior no outro. As observações feitas indicam que, em geral, o estêrco deve ser colocado sob os camalhões.This paper reports the results of nine experiments conducted in the State of Sao Paulo on methods of application of NPK and manure for sweet potatoes (Ipomoea batatas Lam.. In two of the four trails with NPK, better results were obtained where it was broadcast before ridging than where it was placed in o furrow either under or on the top of the ridges. In the other two, the placement under the ridges showed better in the average, but the yearly results varied considerably. As the suitability of different methods of application depends on many factors, especially on the weather, the authors point to
Ghestem, Jean Philippe; Fisicaro, Paula; Champion, Rachel
The trial presented here was conducted by BRGM in collaboration with LNE under the work program AQUAREF 2009 with the support of ONEMA. This is a collaborative trial on groundwater sampling and on field physico chemical measurement. It is not a proficiency test. He had three goals: * Observe and evaluate the practices of groundwater sampling to improve future guides, standards and specifications. * Assess the impact of sampling on variability of results. * Study the accuracy of field measurem...
Lindley, Dennis V.
It is argued that the determination of bioequivalence involves a decision, and is not purely a problem of inference. A coherent method of decision-making is examined in detail for a simple trial of bioequivalence. The result is shown to differ seriously from the inferential method, using significance tests, ordinarily used. The reason for the difference is explored. It is shown how the decision-analytic method can be used in more complicated and realistic trials and the case...
Murphy, Sean C.; Shott, Joseph P.; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V. Ann
Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wi...
Miller, F. G.; Kaptchuk, T J
Participants are often not informed by investigators who conduct randomised, placebo‐controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo‐controlled acupuncture trials should be provided an accurate disc...
Tupasi, Thelma; Danilovits, Manfred; Cirule, Andra; Sanchez-Garavito, Epifanio; Xiao, Heping; Cabrera-Rivero, Jose L; Vargas-Vasquez, Dante E; Gao, Mengqiu; Awad, Mohamed; Gentry, Leesa M; Geiter, Lawrence J; Wells, Charles D
Abstract Problem New drugs for infectious diseases often need to be evaluated in low-resource settings. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities. Approach We carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization – Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues. Local setting Trials were conducted at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America). Eight of the 10 sites in low-resource settings had no experience in conducting the requisite clinical trials. Relevant changes Extensive capacity-building was done in all 10 sites. The programme resulted in improved local capacity in key areas such as trial design, data safety and monitoring, trial conduct and laboratory services. Lessons learnt Clinical trials designed to generate data for regulatory approval require additional efforts beyond traditional research-capacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial. PMID:26908964
Full Text Available World Health Organization (WHO has defined herbal medicines as finished labeled medicinal product that contain an active ingredient, aerial, or underground parts of the plant or other plant material or combinations. According to a report of WHO, about 80% of the world population is reported to rely on traditional medicine for their primary health care needs. Even in the developed countries, complementary or alternative medicine is gaining popularity. A report of a global survey on national policy on traditional medicine and regulation of herbal medicines indicated that about 50 countries including China, Japan, and Germany already have their national policy and laws on regulations of traditional medicines. Herbal drugs possess a long history of its use and better patient tolerance. These are cheaper and easily available in countries like India due to rich agro culture conditions. However, reckless utilization of resources threatens the sustainability of several plant species. Traditional medicines are governed by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. In 1959, the Government of India amended the Drugs and Cosmetics Act to include drugs that are derived from traditional Indian medicine. In 1993, the guidelines for the safety and efficacy of herbal medicines developed by an expert committee directed that the procedures laid down by the office of the Drug Controller General of India for allopathic drugs should be followed for all traditional and herbal products to enter into clinical trials for any therapeutic condition. However, there are certain loop holes in the clinical trials of herbal drugs as the lack of stringent bylaws and regulations. Hence, a deep insight of important challenges and major regulatory guidelines for clinical trial of herbal drugs and botanicals is discussed in the present communication. There is lack of scientific evidence to evaluate safety and efficacy of herbal drugs. The quality
Parveen, Abida; Parveen, Bushra; Parveen, Rabea; Ahmad, Sayeed
World Health Organization (WHO) has defined herbal medicines as finished labeled medicinal product that contain an active ingredient, aerial, or underground parts of the plant or other plant material or combinations. According to a report of WHO, about 80% of the world population is reported to rely on traditional medicine for their primary health care needs. Even in the developed countries, complementary or alternative medicine is gaining popularity. A report of a global survey on national policy on traditional medicine and regulation of herbal medicines indicated that about 50 countries including China, Japan, and Germany already have their national policy and laws on regulations of traditional medicines. Herbal drugs possess a long history of its use and better patient tolerance. These are cheaper and easily available in countries like India due to rich agro culture conditions. However, reckless utilization of resources threatens the sustainability of several plant species. Traditional medicines are governed by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. In 1959, the Government of India amended the Drugs and Cosmetics Act to include drugs that are derived from traditional Indian medicine. In 1993, the guidelines for the safety and efficacy of herbal medicines developed by an expert committee directed that the procedures laid down by the office of the Drug Controller General of India for allopathic drugs should be followed for all traditional and herbal products to enter into clinical trials for any therapeutic condition. However, there are certain loop holes in the clinical trials of herbal drugs as the lack of stringent bylaws and regulations. Hence, a deep insight of important challenges and major regulatory guidelines for clinical trial of herbal drugs and botanicals is discussed in the present communication. There is lack of scientific evidence to evaluate safety and efficacy of herbal drugs. The quality of the trial drug
Evans, Scott R.
Statistics are an integral part of clinical trials. Elements of statistics span clinical trial design, data monitoring, analyses, and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of clinical trials. This manuscript outlines common statistical concerns in clinical trials that are important for clinicians to understand.
... 7 Agriculture 2 2010-01-01 2010-01-01 false Act. 35.1 Section 35.1 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices... Definitions § 35.1 Act. Act or Export Grape and Plum Act means “An Act to promote the foreign trade of...
On January 14, 2009, the German federal government introduced into parliament the 10th Act Amending the Atomic Energy Act. In the first reading in the federal parliament, Federal Minister for the Environment Gabriel emphasized 2 main points: Intensified protection of nuclear facilities and of transports of radioactive substances against unauthorized interventions; transfer by law to the Federal Office for Radiological Protection (BfS) of decommissioning of the Asse mine. Reliability review: The amendment to Sec.12 b of the Atomic Energy Act is to meet the different safety and security conditions after the terrorist attacks on September 11, 2001 in the United States and other terrorist activities afterwards (London, Madrid) also with respect to hazards arising to nuclear facilities and nuclear transports. The bill must be seen in conjunction with the Ordinance on Reliability Reviews under the Atomic Energy Act dated July 1, 1999 which covers reviews of reliability of persons holding special responsibilities. Asse II mine: The competence of the Federal Office for Radiological Protection is achieved by an amendment to Sec.23, Para.1, Number 2, Atomic Energy Act, in which the words ''and for the Asse II mine'' are added after the word ''waste.'' Further proceedings depend on the additional provision in a new Sec.57 b, Atomic Energy Act. Accordingly, the operation and decommissioning of the Asse II mine are subject to the regulations applicable to facilities of the federation pursuant to Sec.9a, Para.3. In this way, Asse II is given the same legal status as the federal waste management facilities. Moreover, it is stipulated that the mine is to be shut down immediately. (orig.)
Gustafsson, Finn; Atar, Dan; Pitt, Bertram;
Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...