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Sample records for activity trial registration

  1. Clinical trial registration in oral health journals.

    PubMed

    Smaïl-Faugeron, V; Fron-Chabouis, H; Durieux, P

    2015-03-01

    Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials.

  2. Legislation for trial registration and data transparency.

    PubMed

    Bian, Zhao-Xiang; Wu, Tai-Xiang

    2010-05-26

    Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement.Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.

  3. The Quality of Registration of Clinical Trials

    PubMed Central

    Viergever, Roderik F.; Ghersi, Davina

    2011-01-01

    Background Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials. Methods and Findings A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame. Conclusions Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records. PMID:21383991

  4. Trials registration: a new era in Thailand.

    PubMed

    Kulvichit, Kittisak; Tulvatana, Wasee; Thinkhamrop, Bandit; Tatsanavivat, Pyatat

    2013-10-01

    Registration of clinical trials or research can result in many benefits. Patients have access to pertinent information. We have a better and more indicative picture of research status in areas where registration is mandatory. Researchers can use the information to form a common interest group and collaborate their research as well as to avoid unnecessary duplication. Registered information can also enable detection of defective design and can lead to improvements of trial protocol or its implementation. Most importantly, it can help to reduce problems of publication bias and selective reporting. Journals do not like to publish negative or inconclusive results. Pharmaceutical companies are reluctant to report results that may jeopardize their revenue. We need absolute transparency to utilize evidence with trust.

  5. Comparison of arthroplasty trial publications after registration in ClinicalTrials.gov.

    PubMed

    Smith, Holly N; Bhandari, Mohit; Mahomed, Nizar N; Jan, Meryam; Gandhi, Rajiv

    2012-08-01

    In 2005, the International Committee of Medical Journal Editors established a mandatory trial registration before study enrollment for publication in member journals. Our primary objective was to evaluate the publication rates of arthroplasty trials registered with ClinicalTrials.gov (CTG). We further aimed to examine the consistency of registration summaries with that of final publications. We searched CTG for all trials related to joint arthroplasty and conducted a thorough search for publications resulting from registered closed trials. Of 101 closed and completed trials, we found 23 publications, for an overall publication rate of 22.8%. Registration of arthroplasty trials in CTG does not consistently result in publication or disclosure of results. In addition, changes are frequently made to the final presentation of the data that are not reflected in the trial registry.

  6. Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials

    PubMed Central

    2013-01-01

    Background Established on 1 June 2005, the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is the largest clinical trial registry in Japan, and joined the World Health Organization (WHO) registry network in October 2008. Our aim was to understand the registration trend and overall characteristics of Japan domestic, academic (non-industry-funded) clinical trials, which constitute the main body of registrations in UMIN-CTR. In addition, we aimed to investigate the accessibility of clinical trials in UMIN-CTR to people worldwide, as well as the accessibility of clinical trials conducted in Japan but registered abroad to Japanese people in the Japanese language. Methods We obtained the data for registrations in UMIN-CTR from the UMIN Center, and extracted Japan domestic, academic clinical trials to analyze their registration trend and overall characteristics. We also investigated how many of the trials registered in UMIN-CTR could be accessed from the International Clinical Trials Registry Platform (ICTRP). Finally, we searched ClinicalTrials.gov for all clinical trials conducted in Japan and investigated how many of them were also registered in Japanese registries. All of the above analyses included clinical trials registered from 2 June 2005 to 1 June 2010. Results During the period examined, the registration trend showed an obvious peak around September 2005 and rapid growth from April 2009. Of the registered trials, 46.4% adopted a single-arm design, 34.5% used an active control, only 10.9% were disclosed before trial commencement, and 90.0% did not publish any results. Overall, 3,063 of 3,064 clinical trials registered in UMIN-CTR could be accessed from ICTRP. Only 8.7% of all clinical trials conducted in Japan and registered in ClinicalTrials.gov were also registered in Japanese registries. Conclusions The International Committee of Medical Journal Editors (ICMJE) announcements about clinical trial registration and the Ethical

  7. Clinical Trials Registration and Results Information Submission. Final rule.

    PubMed

    2016-09-21

    This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA.

  8. The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children.

    PubMed

    Dunn, Adam G; Mandl, Kenneth D; Coiera, Enrico; Bourgeois, Florence T

    2013-01-01

    Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

  9. 18 CFR 390.2 - Activities requiring registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... registration. 390.2 Section 390.2 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY PROCEDURAL RULES ELECTRONIC REGISTRATION § 390.2 Activities requiring registration. (a) Electronic registration is a requirement for the following activities: (1) Submission of...

  10. Trial Registration for Public Trust: Making the Case for Medical Devices

    PubMed Central

    2007-01-01

    Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration. PMID:18095047

  11. Trial registration for public trust: making the case for medical devices.

    PubMed

    Sim, Ida

    2008-01-01

    Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration.

  12. Discrepancies between registration and publication of randomised controlled trials: an observational study

    PubMed Central

    Stevenson, Graham; Thornton, James G

    2014-01-01

    Summary Objectives To determine the consistency between information contained in the registration and publication of randomised controlled trials (RCTs). Design An observational study of RCTs published between May 2011 and May 2012 in the British Medical Journal (BMJ) and the Journal of the American Medical Association (JAMA) comparing registry data with publication data. Participants and Settings Data extracted from published RCTs in BMJ and JAMA. Main outcome measures Timing of trial registration in relation to completion of trial data collection and publication. Registered versus published primary and secondary outcomes, sample size. Results We identified 40 RCTs in BMJ and 36 in JAMA. All 36 JAMA trials and 39 (98%) BMJ trials were registered. All registered trials were registered prior to publication. Thirty-two (82%) BMJ trials recorded the date of data completion; of these, in two trials the date of trial registration postdated the registered date of data completion. There were discrepancies between primary outcomes declared in the trial registry information and in the published paper in 18 (47%) BMJ papers and seven (19%) JAMA papers. The original sample size stated in the trial registration was achieved in 24 (60%) BMJ papers and 21 (58%) JAMA papers. Conclusions Compulsory registration of RCTs is meaningless if the content of registry information is not complete or if discrepancies between registration and publication are not reported. This study demonstrates that discrepancies in primary and secondary outcomes and sample size between trial registration and publication remain commonplace, giving further strength to the World Health Organisation’s argument for mandatory completion of a minimum number of compulsory fields. PMID:25057391

  13. Problems with registration-directed clinical trials for lung cancer in Japan.

    PubMed

    Sekine, Ikuo; Nokihara, Hiroshi; Yamamoto, Noboru; Kunitoh, Hideo; Ohe, Yuichiro; Saijo, Nagahiro; Tamura, Tomohide

    2007-09-01

    New anticancer agents against lung cancer are needed because efficacy of chemotherapy is limited. The long time required, low quality, and considerable costs of registration-directed clinical trials in Japan ("Chiken") have been pointed out. The quality of 24 phase I and 41 phase II trials of an anticancer drug for lung cancer were analyzed according to the approval year of the drug. The human resources and infrastructure to support oncology clinical practice and clinical trials were compared between Japan and the USA. A maximum tolerated dose was not defined in any of seven phase I trials before 1989, and was determined in two of six trials between 1989 and 1996 and in seven of 10 trials thereafter. Before 1989, 29 (20%) of 142 patients registered in two trials were ineligible, and the number of ineligible patients was not reported in the five trials. Sample size calculations were not performed in any of seven phase II trials before 1989 and were performed in only four of 10 trials between 1989 and 1996 and in all 23 trials conducted thereafter. The shortage of human resources, including medical oncologists, oncology nurse practitioners and clinical research coordinators, is serious and acute. The infrastructure to support clinical trials also remains insufficient in Japan. In conclusion, registration-directed clinical trials of anticancer agents have advanced significantly during last three decades but remain unsatisfactory. The development of infrastructure and human resources is an urgent task to ensure high-quality clinical trials without unnecessary delays.

  14. Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency.

    PubMed

    Krleža-Jeriç, Karmela; Lemmens, Trudo; Reveiz, Ludovic; Cuervo, Luis Gabriel; Bero, Lisa Anne

    2011-07-01

    The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.

  15. Impact of registration on clinical trials on infection risk in pediatric acute myeloid leukemia.

    PubMed

    Dix, David; Aplenc, Richard; Bowes, Lynette; Cellot, Sonia; Ethier, Marie-Chantal; Feusner, Jim; Gillmeister, Biljana; Johnston, Donna L; Lewis, Victor; Michon, Bruno; Mitchell, David; Portwine, Carol; Price, Victoria; Silva, Mariana; Stobart, Kent; Yanofsky, Rochelle; Zelcer, Shayna; Beyene, Joseph; Sung, Lillian

    2016-04-01

    Little is known about the impact of enrollment on therapeutic clinical trials on adverse event rates. Primary objective was to describe the impact of clinical trial registration on sterile site microbiologically documented infection for children with newly diagnosed acute myeloid leukemia (AML). We conducted a multicenter cohort study that included children aged ≤18 years with de novo AML. Primary outcome was microbiologically documented sterile site infection. Infection rates were compared between those registered and not registered on clinical trials. Five hundred seventy-four children with AML were included of which 198 (34.5%) were registered on a therapeutic clinical trial. Overall, 400 (69.7%) had at least one sterile site microbiologically documented infection. In multiple regression, registration on clinical trials was independently associated with a higher risk of microbiologically documented sterile site infection [adjusted odds ratio (OR) 1.24, 95% confidence interval (CI) 1.01-1.53; p = 0.040] and viridans group streptococcal infection (OR 1.46, 95% CI 1.08-1.98; p = 0.015). Registration on trials was not associated with Gram-negative or invasive fungal infections. Children with newly diagnosed AML enrolled on clinical trials have a higher risk of microbiologically documented sterile site infection. This information may impact on supportive care practices in pediatric AML.

  16. An outline for public registration of clinical trials evaluating medical devices.

    PubMed

    Popp, Richard L; Lorell, Beverly H; Stone, Gregg W; Laskey, Warren; Smith, John J; Kaplan, Aaron V

    2006-04-18

    Public registration of clinical trials is fundamentally important to the integrity of the medical device development process. In addition to fulfilling obligations to those study volunteers, a complete record of trial results provides the general public, clinical community, and medical device manufacturers with a more accurate understanding as to how a specific therapeutic should be used. Although the issues associated with public disclosure of clinical trials are similar to the pharmaceutical industries, the iterative nature of device development introduces differences in what type of information needs to be disclosed during development and commercialization. The Second Dartmouth Device Development Symposium (3D2) held in October 2004 brought together thought leaders representing many of the stakeholders associated with medical device development. This consensus document arising from the proceedings of the 3D2 is offered to provide background to these issues and recommend pathways to implementation of device trial registration.

  17. Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study

    PubMed Central

    de Knegt, Robert J.; Blokzijl, Hans; Kuiken, Sjoerd D.; van Erpecum, Karel J. L.; Willemse, Sophie B.; den Hollander, Jan; van Vonderen, Marit G. A.; Friederich, Pieter; van Hoek, Bart; van Nieuwkerk, Carin M. J.; Drenth, Joost P. H.; Kievit, Wietske

    2016-01-01

    Background Approval of drugs in chronic hepatitis C is supported by registration trials. These trials might have limited generalizability through use of strict eligibility criteria. We compared effectiveness and safety of real world hepatitis C patients eligible and ineligible for registration trials. Methods We performed a nationwide, multicenter, retrospective cohort study of chronic hepatitis C patients treated in the real world. We applied a combined set of inclusion and exclusion criteria of registration trials to our cohort to determine eligibility. We compared effectiveness and safety in eligible vs. ineligible patients, and performed sensitivity analyses with strict criteria. Further, we used log binomial regression to assess relative risks of criteria on outcomes. Results In this cohort (n = 467) 47% of patients would have been ineligible for registration trials. Main exclusion criteria were related to hepatic decompensation and co-morbidity (cardiac disease, anemia, malignancy and neutropenia), and were associated with an increased risk for serious adverse events (RR 1.45–2.31). Ineligible patients developed significantly more serious adverse events than eligible patients (27% vs. 11%, p< 0.001). Effectiveness was decreased if strict criteria were used. Conclusions Nearly half of real world hepatitis C patients would have been excluded from registration trials, and these patients are at increased risk to develop serious adverse events. Hepatic decompensation and co-morbidity were important exclusion criteria, and were related to toxicity. Therefore, new drugs should also be studied in these patients, to genuinely assess benefits and risk of therapy in the real world population. PMID:27598789

  18. Multi-System Verification of Registrations for Image-Guided Radiotherapy in Clinical Trials

    SciTech Connect

    Cui Yunfeng; Galvin, James M.; Straube, William L.; Bosch, Walter R.; Purdy, James A.; Li, X. Allen; Xiao Ying

    2011-09-01

    Purpose: To provide quantitative information on the image registration differences from multiple systems for image-guided radiotherapy (IGRT) credentialing and margin reduction in clinical trials. Methods and Materials: Images and IGRT shift results from three different treatment systems (Tomotherapy Hi-Art, Elekta Synergy, Varian Trilogy) have been sent from various institutions to the Image-Guided Therapy QA Center (ITC) for evaluation for the Radiation Therapy Oncology Group (RTOG) trials. Nine patient datasets (five head-and-neck and four prostate) were included in the comparison, with each patient having 1-4 daily individual IGRT studies. In all cases, daily shifts were re-calculated by re-registration of the planning CT with the daily IGRT data using three independent software systems (MIMvista, FocalSim, VelocityAI). Automatic fusion was used in all calculations. The results were compared with those submitted from institutions. Similar regions of interest (ROIs) and same initial positions were used in registrations for inter-system comparison. Different slice spacings for CBCT sampling and different ROIs for registration were used in some cases to observe the variation of registration due to these factors. Results: For the 54 comparisons with head-and-neck datasets, the absolute values of differences of the registration results between different systems were 2.6 {+-} 2.1 mm (mean {+-} SD; range 0.1-8.6 mm, left-right [LR]), 1.7 {+-} 1.3 mm (0.0-4.9 mm, superior-inferior [SI]), and 1.8 {+-} 1.1 mm (0.1-4.0 mm, anterior-posterior [AP]). For the 66 comparisons in prostate cases, the differences were 1.1 {+-} 1.0 mm (0.0-4.6 mm, LR), 2.1 {+-} 1.7 mm (0.0-6.6 mm, SI), and 2.0 {+-} 1.8 mm (0.1-6.9 mm, AP). The differences caused by the slice spacing variation were relatively small, and the different ROI selections in FocalSim and MIMvista also had limited impact. Conclusion: The extent of differences was reported when different systems were used for image

  19. 77 FR 34055 - Agency Information Collection Activities: Certificate of Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... SECURITY U.S. Customs and Border Protection Agency Information Collection Activities: Certificate of Registration AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: 30-Day notice and request for comments; Extension of an existing information collection. SUMMARY: U.S. Customs...

  20. Complying with the European Clinical Trials directive while surviving the administrative pressure - an alternative approach to toxicity registration in a cancer trial.

    PubMed

    Frandsen, Thomas Leth; Heyman, Mats; Abrahamsson, Jonas; Vettenranta, Kim; Åsberg, Ann; Vaitkeviciene, Goda; Pruunsild, Kaie; Toft, Nina; Birgens, Henrik; Hallböök, Helena; Quist-Paulsen, Petter; Griškevičius, Laimonas; Helt, Louise; Hansen, Birgitte Vilsbøll; Schmiegelow, Kjeld

    2014-01-01

    The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration was excellent with 98.9% of all patients being registered within 5weeks from the requested quarterly registration. Currently, four toxicities (thrombosis, fungal infections, pancreatitis and allergic reactions) have been chosen for further detailed exploration due to the cumulative fraction of patients with positive registrations exceeding 5%. This toxicity registration offers real-time toxicity profiles of the total study cohort and provides early warnings of specific toxicities that require further investigation.

  1. 75 FR 12547 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and... of information technology. Registration of Food Facilities Under the Public Health Security...

  2. Equivalence and noninferiority trials – are they viable alternatives for registration of new drugs? (III)

    PubMed Central

    Pater, Cornel

    2004-01-01

    The scientific community's reliance on active-controlled trials is steadily increasing, as widespread agreement emerges concerning the role of these trials as viable alternatives to placebo trials. These trials present substantial challenges with regard to design and interpretation as their complexity increases, and the potential need for larger sample sizes impacts the cost and time variables of the drug development process. The potential efficacy and safety benefits derived from these trials may never be demonstrated by other methods. Active-controlled trials can develop valuable data to inform both prescribers and patients about the dose- and time-dependent actions of any new drug and can contribute to the management and communication of risks associated with the relevant therapeutic products. PMID:15312236

  3. 45 CFR 1226.5 - Electoral, voter registration, and other activities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    .... Any activity designed to influence the outcome of elections to any public office, such as: (1... campaign literature for candidates, including leaflets pamphlets, and material designed for the print or electronic media; (b) Voter Registration Activities. Any voter registration activity, such as (1)...

  4. 45 CFR 1226.5 - Electoral, voter registration, and other activities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    .... Any activity designed to influence the outcome of elections to any public office, such as: (1... campaign literature for candidates, including leaflets pamphlets, and material designed for the print or electronic media; (b) Voter Registration Activities. Any voter registration activity, such as (1)...

  5. 45 CFR 1226.5 - Electoral, voter registration, and other activities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    .... Any activity designed to influence the outcome of elections to any public office, such as: (1... campaign literature for candidates, including leaflets pamphlets, and material designed for the print or electronic media; (b) Voter Registration Activities. Any voter registration activity, such as (1)...

  6. 45 CFR 1226.5 - Electoral, voter registration, and other activities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    .... Any activity designed to influence the outcome of elections to any public office, such as: (1... campaign literature for candidates, including leaflets pamphlets, and material designed for the print or electronic media; (b) Voter Registration Activities. Any voter registration activity, such as (1)...

  7. How Commonly Used Inclusion and Exclusion Criteria in Antidepressant Registration Trials Affect Study Enrollment.

    PubMed

    Preskorn, Sheldon H; Macaluso, Matthew; Trivedi, Madhukar

    2015-07-01

    In clinical trials, each specific inclusion and exclusion criterion eliminates a percentage of the potentially eligible population from trial participation and thus increases the time and effort needed for enrollment in a study. Drug developers often do not have data on how these criteria affect the pool of potentially eligible subjects for their trials and, hence, they cannot factor in the impact of these criteria when designing a study and planning the time needed to complete it. Consequently, drug developers often have ambitious timelines that are unrealistic and can lead to actions that may interfere with the ability to separate the efficacy of drug versus placebo. To investigate the effects of inclusion and exclusion criteria on study enrollment, the authors quantified the effects of the inclusion and exclusion criteria commonly used in antidepressant registration trials (ARTs) by applying these criteria to the population treated in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. In essence, the STAR*D study population was used as a surrogate for the general population of individuals with major depressive disorder. The effect of each criterion commonly used in ARTs was assessed in terms of the percentage of the STAR*D population that would have been excluded individually and collectively (i.e., when all criteria were applied at once). For continuous criteria such as age and severity of depression, the resulting effects have been presented graphically. Collectively, the typical inclusion and exclusion criteria used in ARTs would have eliminated at least 82% of the STAR*D population. This result means that more than 5 times the number of subjects would have to be screened to find a population that would meet the typical inclusion and exclusion criteria for an ART, directly determining the screening effort required in terms of both resources and time. Thus, developers of antidepressant drugs can use the data from this study to plan the

  8. 45 CFR 1226.5 - Electoral, voter registration, and other activities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Electoral, voter registration, and other...) CORPORATION FOR NATIONAL AND COMMUNITY SERVICE PROHIBITIONS ON ELECTORAL AND LOBBYING ACTIVITIES Sponsoring Organization § 1226.5 Electoral, voter registration, and other activities. Volunteers or other assistance,...

  9. Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence

    PubMed Central

    McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

    2016-01-01

    Background Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people’s early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. Objective The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. Methods In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. Results The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated

  10. 78 FR 75343 - Pesticide Products; Registration Applications for New Active Ingredients

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-11

    ... AGENCY Pesticide Products; Registration Applications for New Active Ingredients AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has received several applications to register pesticide products containing active ingredients not included in any currently registered pesticide...

  11. 76 FR 39900 - Agency Information Collection Activities: Application for Registration of Firearms Acquired by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... of Alcohol, Tobacco, Firearms and Explosives Agency Information Collection Activities: Application for Registration of Firearms Acquired by Certain Governmental Entities ACTION: 60-Day Notice. The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be...

  12. 76 FR 56223 - Agency Information Collection Activities: Application for Registration of Firearms Acquired by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ... of Alcohol, Tobacco, Firearms and Explosives Agency Information Collection Activities: Application for Registration of Firearms Acquired by Certain Governmental Entities ACTION: 60-Day Notice. The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be...

  13. 78 FR 76613 - Registration Applications for Pesticide Products Containing New Active Ingredients; Corrections

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-18

    ... in the Federal Register of August 14, 2012, concerning a new active ingredient (AI). The name of an AI was changed during the registration assessment process. This document corrects the name of the...

  14. Active Clinical Trials for Personalized Medicine

    PubMed Central

    Minsker, Stanislav; Zhao, Ying-Qi; Cheng, Guang

    2016-01-01

    Individualized treatment rules (ITRs) tailor treatments according to individual patient characteristics. They can significantly improve patient care and are thus becoming increasingly popular. The data collected during randomized clinical trials are often used to estimate the optimal ITRs. However, these trials are generally expensive to run, and, moreover, they are not designed to efficiently estimate ITRs. In this article, we propose a cost-effective estimation method from an active learning perspective. In particular, our method recruits only the “most informative” patients (in terms of learning the optimal ITRs) from an ongoing clinical trial. Simulation studies and real-data examples show that our active clinical trial method significantly improves on competing methods. We derive risk bounds and show that they support these observed empirical advantages. Supplementary materials for this article are available online. PMID:28018014

  15. Health Activities Project (HAP), Trial Edition II.

    ERIC Educational Resources Information Center

    Buller, Dave; And Others

    Contained within this Health Activities Project (HAP) trial edition (set II) are a teacher information folio and numerous student activity folios which center around the idea that students in grades 5-8 can control their own health and safety. Each student folio is organized into a Synopsis, Health Background, Materials, Setting Up, and Activities…

  16. [Progress and challenges of clinical trials registration in Latin America and the Caribbean's].

    PubMed

    Reveiz, Ludovic; Saenz, Carla; Murasaki, Renato T; Cuervo, Luis G; Ramalho, Luciano

    2011-12-01

    Clinical trial registries are one of the main sources of information concerning health research interventions that have been or are being carried out throughout the world. The World Health Organization (WHO) established a minimum data set to be recorded (20 items), which was agreed upon internationally with the stakeholders, and established a network of primary and associated records. In addition to the register ClinicalTrial.Gov (of the United States of America), there are currently two primary registries in the Americas (from Brazil and Cuba) that meet WHO requirements and provide data to WHO's International Clinical Trials Registry Platform (ICTRP). Furthermore, there are important advances in the region related to the regulations, development and implementation of national registries and to the support of the ethics committees and editors to this initiative.

  17. Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details

    PubMed Central

    Buffel du Vaure, Céline; Dechartres, Agnès; Battin, Constance; Ravaud, Philippe; Boutron, Isabelle

    2016-01-01

    Objectives To systematically assess registration details of ongoing randomised controlled trials (RCTs) targeting 10 common chronic conditions and registered at ClinicalTrials.gov and to determine the prevalence of (1) trial records excluding patients with concomitant chronic condition(s) and (2) those specifically targeting patients with concomitant chronic conditions. Design Systematic review of trial registration records. Data sources ClinicalTrials.gov register. Study selection All ongoing RCTs registered from 1 January 2014 to 31 January 2015 that assessed an intervention targeting adults with coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease, painful condition, depression and dementia with a target sample size ≥100. Data extraction From the trial registration records, 2 researchers independently recorded the trial characteristics and the number of exclusion criteria and determined whether patients with concomitant chronic conditions were excluded or specifically targeted. Results Among 319 ongoing RCTs, despite the high prevalence of the concomitant chronic conditions, patients with these conditions were excluded in 251 trials (79%). For example, although 91% of patients with CHD had a concomitant chronic condition, 69% of trials targeting such patients excluded patients with concomitant chronic condition(s). When considering the co-occurrence of 2 chronic conditions, 31% of patients with chronic pain also had depression, but 58% of the trials targeting patients with chronic pain excluded patients with depression. Only 37 trials (12%) assessed interventions specifically targeting patients with concomitant chronic conditions; 31 (84%) excluded patients with concomitant chronic condition(s). Conclusions Despite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions

  18. Trial Registration: Understanding and Preventing Reporting Bias in Social Work Research

    ERIC Educational Resources Information Center

    Harrison, Bronwyn A.; Mayo-Wilson, Evan

    2014-01-01

    Randomized controlled trials are considered the gold standard for evaluating social work interventions. However, published reports can systematically overestimate intervention effects when researchers selectively report large and significant findings. Publication bias and other types of reporting biases can be minimized through prospective trial…

  19. 21 CFR 1301.11 - Persons required to register; requirement of modification of registration authorizing activity as...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... modification of registration authorizing activity as an online pharmacy. 1301.11 Section 1301.11 Food and Drugs... modification of registration authorizing activity as an online pharmacy. (a) Every person who manufactures... “online pharmacy” (as set forth in section 102(52) of the Act (21 U.S.C. 802(52)) and § 1300.04(h) of...

  20. 21 CFR 1301.11 - Persons required to register; requirement of modification of registration authorizing activity as...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... modification of registration authorizing activity as an online pharmacy. 1301.11 Section 1301.11 Food and Drugs... modification of registration authorizing activity as an online pharmacy. (a) Every person who manufactures... “online pharmacy” (as set forth in section 102(52) of the Act (21 U.S.C. 802(52)) and § 1300.04(h) of...

  1. 21 CFR 1301.11 - Persons required to register; requirement of modification of registration authorizing activity as...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... modification of registration authorizing activity as an online pharmacy. 1301.11 Section 1301.11 Food and Drugs... modification of registration authorizing activity as an online pharmacy. (a) Every person who manufactures... “online pharmacy” (as set forth in section 102(52) of the Act (21 U.S.C. 802(52)) and § 1300.04(h) of...

  2. 21 CFR 1309.24 - Waiver of registration requirement for certain activities.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... activities with respect to List I chemicals are limited to the distribution of red phosphorus, white phosphorus, or hypophosphorous acid (and its salts) to another location operated by the same firm solely for... disposal. (f) The requirement of registration is waived for any person whose distribution of red...

  3. 21 CFR 1309.24 - Waiver of registration requirement for certain activities.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... activities with respect to List I chemicals are limited to the distribution of red phosphorus, white phosphorus, or hypophosphorous acid (and its salts) to another location operated by the same firm solely for... disposal. (f) The requirement of registration is waived for any person whose distribution of red...

  4. Comparison of global versus Asian clinical trial strategies supportive of registration of drugs in Japan.

    PubMed

    Shirotani, Mari; Kurokawa, Tatsuo; Chiba, Koji

    2014-07-01

    The number of worldwide and Asian multiregional clinical trials (MRCTs) submitted for Japanese New Drug Applications increased markedly between 2009 and 2013, with an increasing number performed for simultaneously submission in the USA, EU, and Japan. Asian studies accounted for 32% of MRCTs (14/44 studies) and had comparatively small sample sizes (<500 subjects). Moreover, the number of Japanese subjects in Asian studies was 2.1- to 13.4-fold larger than the sample size estimated using the method described in Japanese MRCT guidelines, whereas the ratio for worldwide studies was 0.05- to 4.9-fold. Before the introduction of this guidelines, bridging or domestic clinical development strategies were used as the regional development strategy in accordance with ICH E5 guidelines. The results presented herein suggest that Asian studies were conducted when the drug had already been approved in the US/EU, when phase 3 clinical trials were not be planned in the USA/EU, when there was insufficient knowledge of ethnic differences in drug efficacy and safety, or when Caucasian data could not be extrapolated to the Japanese population. New strategies with Asian studies including the Japanese population could be conducted instead of Japanese domestic development strategy.

  5. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

    PubMed Central

    Miller, Jennifer E; Korn, David; Ross, Joseph S

    2015-01-01

    Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve

  6. 40 CFR 152.113 - Approval of registration under FIFRA sec. 3(c)(7)-Products that do not contain a new active...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... available an effective alternative registered pesticide which does not meet the risk criteria associated... of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION... registration of a pesticide product, each of whose active ingredients is contained in one or more...

  7. Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs: 2015 Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health

    PubMed Central

    Talbot, George H.; Powers, John H.; Hoffmann, Steven C.

    2016-01-01

    One important component in determining the benefits and harms of medical interventions is the use of well-defined and reliable outcome assessments as endpoints in clinical trials. Improving endpoints can better define patient benefits, allowing more accurate assessment of drug efficacy and more informed benefit-vs-risk decisions; another potential plus is facilitating efficient trial design. Since our first report in 2012, 2 Foundation for the National Institutes of Health Biomarkers Consortium Project Teams have continued to develop outcome assessments for potential uses as endpoints in registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. In addition, the teams have initiated similar work in the indications of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. This report provides an update on progress to date in these 4 diseases. PMID:26668337

  8. Contamination by an Active Control Condition in a Randomized Exercise Trial

    PubMed Central

    Kramer, Arthur F.; McAuley, Edward

    2016-01-01

    Contamination is commonly overlooked in randomized trials. The present study examined contamination (minutes of aerobic activity outside of exercise sessions) within an active control condition in a 6-month randomized exercise trial for older adults. We hypothesized that outside aerobic activity would be greater in the control condition compared to the intervention conditions. Participants (mean age = 65.06 years, 66.2% female) were randomly assigned to: Dance (n = 50), Walking, (n = 108), or Strength/Stretching/Stability (SSS; n = 48). Dance and Walking represented the experimental conditions and SSS the control condition. Participants attended exercise sessions three times weekly for 24 weeks. Participants recorded their physical activity outside of class on a weekly home log. Group assignment and covariates (age, gender, body mass index, exercise session intensity and enjoyment, and program adherence) were examined as predictors of weekly aerobic activity outside of exercise sessions. Participants who returned zero home logs were removed from the dataset (final N = 195). Out-of-class aerobic activity was lowest in the Walking group. Significant effects of gender, group, enjoyment, and intensity on out-of-class weekly aerobic activity were observed, all p<0.003. Higher perceived enjoyment of exercise sessions was associated with more out-of-class aerobic activity, while higher perceived intensity was associated with less out-of-class aerobic activity. A group x intensity interaction, p = 0.002, indicated that group differences in out-of-class aerobic activity were evident only among those with lower intensity perceptions. Walkers may have perceived exercise sessions as sufficient weekly exercise, while the Dance and SSS groups may have perceived the sessions as necessary, but insufficient. The lower aerobic intensity Dancers attributed to exercise sessions and non-aerobic nature of SSS may partially explain contamination observed in this study. Further

  9. An active contour-based atlas registration model applied to automatic subthalamic nucleus targeting on MRI: method and validation.

    PubMed

    Duay, Valérie; Bresson, Xavier; Castro, Javier Sanchez; Pollo, Claudio; Cuadra, Meritxell Bach; Thiran, Jean-Philippe

    2008-01-01

    This paper presents a new non parametric atlas registration framework, derived from the optical flow model and the active contour theory, applied to automatic subthalamic nucleus (STN) targeting in deep brain stimulation (DBS) surgery. In a previous work, we demonstrated that the STN position can be predicted based on the position of surrounding visible structures, namely the lateral and third ventricles. A STN targeting process can thus be obtained by registering these structures of interest between a brain atlas and the patient image. Here we aim to improve the results of the state of the art targeting methods and at the same time to reduce the computational time. Our simultaneous segmentation and registration model shows mean STN localization errors statistically similar to the most performing registration algorithms tested so far and to the targeting expert's variability. Moreover, the computational time of our registration method is much lower, which is a worthwhile improvement from a clinical point of view.

  10. Reasons for non-participation in a primary care-based physical activity trial: a qualitative study

    PubMed Central

    Attwood, S; Morton, K L; Mitchell, J; Van Emmenis, M; Sutton, S

    2016-01-01

    Objectives To explore reasons for non-participation in a primary care-based physical activity trial and understand how these may contribute to recruitment of non-representative research samples. We also aimed to elicit non-participants’ own recommendations for enhancing trial uptake in primary care. Design Semistructured telephone interviews with non-participants to a randomised controlled trial of a very brief intervention for promoting physical activity conducted in primary care (the Very Brief Interventions trial), with thematic analysis of interview transcripts. Setting 5 general practice (GP) surgeries in the East of England, UK. Participants Interviews were completed with 10 female and 6 male non-participants of white ethnicity and aged between 40 and 71 years. 13 of the 16 interviewees were either active or moderately active according to the GP Physical Activity Questionnaire (GPPAQ). Results Interviewees discussed a range of reasons for non-participation. These included beliefs surrounding the personal relevance of the trial based on preconceptions of intervention content. Many interviewees considered themselves either sufficiently active or too functionally limited to increase activity levels further, so rendering participation pointless in their view. Other identified barriers included a lack of free time, for trial participation and for increasing physical activity, and dissatisfaction with appointment scheduling systems in place at GP surgeries. Interviewees questioned the appropriateness of primary care as a context for delivering interventions to promote physical activity. In general, interviewees were positively disposed towards the idea of trial participation, especially if personal benefits are made salient, but suggested that interventions could be delivered in a different setting such as the internet. Conclusions To increase participation in physical activity promotion trials conducted in primary care, the content of invitation materials and

  11. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up

    PubMed Central

    2014-01-01

    Background Low levels of physical activity, musculoskeletal morbidity and weight gain are commonly reported problems in children with cancer. Intensive medical treatment and a decline in physical activity may also result in reduced motor performance. Therefore, simple and inexpensive ways to promote physical activity and exercise are becoming an increasingly important part of children’s cancer treatment. Methods The aim of this study is to evaluate the effect of active video games in promotion of physical activity in children with cancer. The research is conducted as a parallel randomized clinical trial with follow-up. Patients between 3 and 16 years old, diagnosed with cancer and treated with vincristine in two specialized medical centers are asked to participate. Based on statistical estimates, the target enrollment is 40 patients. The intervention includes playing elective active video games and, in addition, education and consultations for the family. The control group will receive a general recommendation for physical activity for 30 minutes per day. The main outcomes are the amount of physical activity and sedentary behavior. Other outcomes include motor performance, fatigue and metabolic risk factors. The outcomes are examined with questionnaires, diaries, physical examinations and blood tests at baseline and at 2, 6, 12 and 30 months after the baseline. Additionally, the children’s perceptions of the most enjoyable activation methods are explored through an interview at 2 months. Discussion This trial will help to answer the question of whether playing active video games is beneficial for children with cancer. It will also provide further reasoning for physical activity promotion and training of motor skills during treatment. Trial registration ClinicalTrials.gov identifier: NCT01748058 (October 15, 2012). PMID:24708773

  12. 11 CFR 100.149 - Voter registration and get-out-the-vote activities for Presidential candidates.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... overall activity. (e) Phone banks. For purposes of this section, payment of the costs incurred in the use of phone banks in connection with voter registration and get-out-the-vote activities is not an expenditure when such phone banks are operated by volunteer workers. The use of paid professionals to...

  13. 11 CFR 100.89 - Voter registration and get-out-the-vote activities for Presidential candidates.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... candidate(s) is merely incidental to the overall activity. (e) Phone banks. For purposes of this section, payment of the costs incurred in the use of phone banks in connection with voter registration and get-out-the-vote activities is not a contribution when such phone banks are operated by volunteer workers....

  14. Population activity changes during a trial-to-trial adaptation of bullfrog retinal ganglion cells.

    PubMed

    Ding, Wei; Xiao, Lei; Jing, Wei; Zhang, Pu-Ming; Liang, Pei-Ji

    2014-07-09

    A 'trial-to-trial adaptation' of bullfrog retinal ganglion cells in response to a repetitive light stimulus was investigated in the present study. Using the multielectrode recording technique, we studied the trial-to-trial adaptive properties of ganglion cells and explored the activity of population neurons during this adaptation process. It was found that the ganglion cells adapted with different degrees: their firing rates were decreased in different extents from early-adaptation to late-adaptation stage, and this was accompanied by a decrease in cross-correlation strength. In addition, adaptation behavior was different for ON-response and OFF-response, which implied that the mechanism of the trial-to-trial adaptation might involve bipolar cells and/or their synapses with other neurons and the stronger adaptation in the ganglion cells' OFF-responses might reflect the requirement to avoid possible saturation in the OFF circuit.

  15. A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial

    PubMed Central

    Ferguson, Monika; Vandelanotte, Corneel; Plotnikoff, Ron; De Bourdeaudhuij, Ilse; Thomas, Samantha; Nelson-Field, Karen; Olds, Tim

    2015-01-01

    pedometers can produce sizable short-term physical activity changes. Future work is needed to determine how to maintain behavior change in the longer term, how to reach at-need populations, and how to disseminate such interventions on a mass scale. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000488606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366239 (Archived by WebCite at http://www.webcitation.org/6ZVtu6TMz). PMID:26169067

  16. 40 CFR 152.114 - Approval of registration under FIFRA sec. 3(c)(7)-Products that contain a new active ingredient.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of... CLASSIFICATION PROCEDURES Agency Review of Applications § 152.114 Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a new active ingredient. An application for registration of a...

  17. 40 CFR 152.114 - Approval of registration under FIFRA sec. 3(c)(7)-Products that contain a new active ingredient.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of... CLASSIFICATION PROCEDURES Agency Review of Applications § 152.114 Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a new active ingredient. An application for registration of a...

  18. 40 CFR 152.114 - Approval of registration under FIFRA sec. 3(c)(7)-Products that contain a new active ingredient.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of... CLASSIFICATION PROCEDURES Agency Review of Applications § 152.114 Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a new active ingredient. An application for registration of a...

  19. 40 CFR 152.114 - Approval of registration under FIFRA sec. 3(c)(7)-Products that contain a new active ingredient.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of... CLASSIFICATION PROCEDURES Agency Review of Applications § 152.114 Approval of registration under FIFRA sec. 3(c)(7)—Products that contain a new active ingredient. An application for registration of a...

  20. Invasion of the Zebra Mussels: A Mock Trial Activity

    ERIC Educational Resources Information Center

    Beck, Judy A.; Czerniak, Charlene M.

    2005-01-01

    In this activity, students learn about the important topic of invasive species, specifically Zebra Mussels. Students role-play different characters in a real-life situation: the trial of the Zebra Mussel for unlawful disruption of the Great Lakes ecosystem. Students will also learn about jurisprudential inquiry by examining the trial process. This…

  1. 77 FR 57568 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-18

    ... Collection; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products; Correction AGENCY: Food and Drug... Agency pertaining to registration and product listing for owners and operators of domestic...

  2. The Devon Active Villages Evaluation (DAVE) trial of a community-level physical activity intervention in rural south-west England: a stepped wedge cluster randomised controlled trial

    PubMed Central

    2014-01-01

    ineffectiveness of the intervention may have been due to its low penetration—only 16% of intervention mode participants reported awareness of the intervention and just 4% reported participating in intervention events. Conclusions A community-level physical activity intervention providing tailored physical activity opportunities to rural villages did not improve physical activity levels in adults. Greater penetration of such interventions must be achieved if they are to increase physical activity prevalence at the community level. Trial Registration Current Controlled Trials ISRCTN37321160. PMID:25198068

  3. Clinical trials: active control vs placebo--what is ethical?

    PubMed

    Spławiński, Jacek; Kuźniar, Jerzy

    2004-01-01

    The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs, superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of micro (the difference between a tested drug and comparator) < or = 0 against micro > 0; the latter tests the null hypothesis of micro < or = - delta against, micro > - delta, where delta is the clinical difference from the comparator. In a superiority trial, a new drug is tested against a placebo; in a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with placebo to a non-inferiority trial with an active-control--following the latest revision of Declaration of Helsinki--is in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical: to violate patients' rights or to produce results without scientific value. All presented considerations lead to the conclusion that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation of patients, and the ancient quest for effective medicines. In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is fruitless.

  4. Suspension of Registrations under FIFRA

    EPA Pesticide Factsheets

    Under FIFRA Section 3(c)(2)(B), this generally halts further distribution and sale of the suspended pesticide product by the registrant. Find suspension listings by product name, active ingredient, registrant name, date, and contact information.

  5. Tighter process control of poly- and active-to-contact overlay registration via multilayer analysis

    NASA Astrophysics Data System (ADS)

    Lee, Peter M. C.; Knutrud, Paul C.

    2000-06-01

    As process technology in high volume production fabs hits the 180 nm window, overlay metrology of the most critical layers needs to be managed very carefully. As feature sizes and other device characteristics shrink, the overlay requirement becomes a larger component of the overall process specification. It is no longer sufficient to measure overlay for only two layers at a time. In no other part of the process is this more critical than the poly and active layer to first contact. The contact layer needs to be aligned to both active and poly within tight tolerances. Since adjustments to overlay for these levels are not independent, it is essential to understand the relationship between all three layers. TSMC in particular, because it is a foundry, is not able to optimize customer circuit design that would allow two-layer registration to be sufficient. Previously, the only method to accomplish this has been to make two sets of overlay measurements and having an engineer analyze the relative overlay between the three layers. The proposed solution to solve this problem is a multi-layer overlay measurement algorithm and measurement target. This paper will report on the analysis of the process improvements that have and can be achieved using this unique measurement capability.

  6. EEG activity represents the correctness of perceptual decisions trial-by-trial

    PubMed Central

    Pardo-Vazquez, Jose L.; Padrón, Isabel; Fernández-Rey, José; Acuña, Carlos

    2014-01-01

    Performance monitoring is an executive function, which we depend on for detecting and evaluating the consequences of our behavior. Although event related potentials (ERPs) have revealed the existence of differences after correct and incorrect decisions, it is not known whether there is a trial-by-trial representation of the accuracy of the decision. We recorded the electroencephalographic activity (EEG) while participants performed a perceptual discrimination task, with two levels of difficulty, in which they received immediate feedback. Receiver Operating Characteristic (ROC) analyses were used to reveal two components that convey trial-by-trial representations of the correctness of the decisions. Firstly, the performance monitoring-related negativity (PM-N), a negative deflection whose amplitude is higher (more negative) after incorrect trials. Secondly, the performance monitoring-related positivity (PM-P), a positive deflection whose amplitude is higher after incorrect trials. During the time periods corresponding to these components, trials can be accurately categorized as correct or incorrect by looking at the EEG activity; this categorization is more accurate when based on the PM-P. We further show that the difficulty of the discrimination task has a different effect on each component: after easy trials the latency of the PM-N is shorter and the amplitude of the PM-P is higher than after difficult trials. Consistent with previous interpretations of performance-related ERPs, these results suggest a functional differentiation between these components. The PM-N could be related to an automatic error detection system, responsible for fast behavioral corrections of ongoing actions, while the PM-P could reflect the difference between expected and actual outcomes and be related to long-term changes in the decision process. PMID:24734012

  7. 40 CFR 152.114 - Approval of registration under FIFRA sec. 3(c)(7)-Products that contain a new active ingredient.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND...)(7)—Products that contain a new active ingredient. An application for registration of a pesticide... § 152.112(a), (b), (d), and (f) through (h) have been satisfied; (d) The use of the pesticide...

  8. Reductions in disease activity in the AMPLE trial: clinical response by baseline disease duration

    PubMed Central

    Schiff, Michael; Weinblatt, Michael E; Valente, Robert; Citera, Gustavo; Maldonado, Michael; Massarotti, Elena; Yazici, Yusuf; Fleischmann, Roy

    2016-01-01

    Objectives To evaluate clinical response by baseline disease duration using 2-year data from the AMPLE trial. Methods Patients were randomised to subcutaneous abatacept 125 mg weekly or adalimumab 40 mg bi-weekly, with background methotrexate. As part of a post hoc analysis, the achievement of validated definitions of remission (Clinical Disease Activity Index (CDAI) ≤2.8, Simplified Disease Activity Index (SDAI) ≤3.3, Routine Assessment of Patient Index Data 3 (RAPID3) ≤3.0, Boolean score ≤1), low disease activity (CDAI <10, SDAI <11, RAPID3 ≤6.0), Health Assessment Questionnaire-Disability Index response and American College of Rheumatology responses were evaluated by baseline disease duration (≤6 vs >6 months). Disease Activity Score 28 (C-reactive protein) <2.6 or ≤3.2 and radiographic non-progression in patients achieving remission were also evaluated. Results A total of 646 patients were randomised and treated (abatacept, n=318; adalimumab, n=328). In both treatment groups, comparable responses were achieved in patients with early rheumatoid arthritis (≤6 months) and in those with later disease (>6 months) across multiple clinical measures. Conclusions Abatacept or adalimumab with background methotrexate were associated with similar onset and sustainability of response over 2 years. Patients treated early or later in the disease course achieved comparable clinical responses. Trial registration number NCT00929864, Post-results. PMID:27110385

  9. BCG vaccination induces HIV target cell activation in HIV-exposed infants in a randomized trial

    PubMed Central

    Gasper, Melanie A.; Hesseling, Anneke C.; Mohar, Isaac; Myer, Landon; Azenkot, Tali; Passmore, Jo-Ann S.; Hanekom, Willem; Cotton, Mark F.; Crispe, I. Nicholas; Sodora, Donald L.; Jaspan, Heather B.

    2017-01-01

    BACKGROUND. Bacillus Calmette-Guérin (BCG) vaccine is administered at birth to protect infants against tuberculosis throughout Africa, where most perinatal HIV-1 transmission occurs. We examined whether BCG vaccination alters the levels of activated HIV target T cells in HIV-exposed South African infants. METHODS. HIV-exposed infants were randomized to receive routine (at birth) or delayed (at 8 weeks) BCG vaccination. Activated and CCR5-expressing peripheral blood CD4+ T cell, monocyte, and NK cell frequencies were evaluated by flow cytometry and immune gene expression via PCR using Biomark (Fluidigm). RESULTS. Of 149 infants randomized, 92% (n = 137) were retained at 6 weeks: 71 in the routine BCG arm and 66 in the delayed arm. Routine BCG vaccination led to a 3-fold increase in systemic activation of HIV target CD4+CCR5+ T cells (HLA-DR+CD38+) at 6 weeks (0.25% at birth versus 0.08% in delayed vaccination groups; P = 0.029), which persisted until 8 weeks of age when the delayed arm was vaccinated. Vaccination of the infants in the delayed arm at 8 weeks resulted in a similar increase in activated CD4+CCR5+ T cells. The increase in activated T cells was associated with increased levels of MHC class II transactivator (CIITA), IL12RB1, and IFN-α1 transcripts within peripheral blood mononuclear cells but minimal changes in innate cells. CONCLUSION. BCG vaccination induces immune changes in HIV-exposed infants, including an increase in the proportion of activated CCR5+CD4+ HIV target cells. These findings provide insight into optimal BCG vaccine timing to minimize the risks of HIV transmissions to exposed infants while preserving potential benefits conferred by BCG vaccination. TRIAL REGISTRATION. ClinicalTrials.gov NCT02062580. FUNDING. This trial was sponsored by the Elizabeth Glaser Pediatric AIDS Foundation (MV-00-9-900-01871-0-00) and the Thrasher Foundation (NR-0095); for details, see Acknowledgments.

  10. Promoting Activity in Geriatric Rehabilitation: A Randomized Controlled Trial of Accelerometry

    PubMed Central

    Paul, Sanjoy K.

    2016-01-01

    Background Low activity levels in inpatient rehabilitation are associated with adverse outcomes. The study aimed to test whether activity levels can be increased by the provision of monitored activity data to patients and clinicians in the context of explicit goal setting. Methods A randomized controlled trial in three sites in Australia included 255 inpatients aged 60 and older who had a rehabilitation goal to become ambulant. The primary outcome was patients’ walking time measured by accelerometers during the rehabilitation admission. Walking times from accelerometry were made available daily to treating therapists and intervention participants to motivate patients to improve incidental activity levels and reach set goals. For the control group, ‘usual care’ was followed, including the setting of mobility goals; however, for this group, neither staff nor patients received data on walking times to aid the setting of daily walking time targets. Results The median daily walking time in the intervention group increased from 10.3 minutes at baseline to 32.1 minutes at day 28, compared with an increase from 9.5 to 26.5 minutes per day in the control group. Subjects in the intervention group had significantly higher non-therapy walking time by about 7 minutes [mean (95% CI): 24.6 (21.7, 27.4)] compared to those in the control group [mean(95% CI): 17.3 (14.4, 20.3)] (p = 0.001). Conclusions Daily feedback to patients and therapists using an accelerometer increased walking times during rehabilitation admissions. The results of this study suggest objective monitoring of activity levels could provide clinicians with information on clinically important, mobility-related activities to assist goal setting. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12611000034932 http://www.ANZCTR.org.au/ PMID:27564857

  11. Simultaneous reconstruction of the activity image and registration of the CT image in TOF-PET

    NASA Astrophysics Data System (ADS)

    Rezaei, Ahmadreza; Michel, Christian; Casey, Michael E.; Nuyts, Johan

    2016-02-01

    Previously, maximum-likelihood methods have been proposed to jointly estimate the activity image and the attenuation image or the attenuation sinogram from time-of-flight (TOF) positron emission tomography (PET) data. In this contribution, we propose a method that addresses the possible alignment problem of the TOF-PET emission data and the computed tomography (CT) attenuation data, by combining reconstruction and registration. The method, called MLRR, iteratively reconstructs the activity image while registering the available CT-based attenuation image, so that the pair of activity and attenuation images maximise the likelihood of the TOF emission sinogram. The algorithm is slow to converge, but some acceleration could be achieved by using Nesterov’s momentum method and by applying a multi-resolution scheme for the non-rigid displacement estimation. The latter also helps to avoid local optima, although convergence to the global optimum cannot be guaranteed. The results are evaluated on 2D and 3D simulations as well as a respiratory gated clinical scan. Our experiments indicate that the proposed method is able to correct for possible misalignment of the CT-based attenuation image, and is therefore a very promising approach to suppressing attenuation artefacts in clinical PET/CT. When applied to respiratory gated data of a patient scan, it produced deformations that are compatible with breathing motion and which reduced the well known attenuation artefact near the dome of the liver. Since the method makes use of the energy-converted CT attenuation image, the scale problem of joint reconstruction is automatically solved.

  12. Study Protocol: A randomized controlled trial of patient navigation-activation to reduce cancer health disparities

    PubMed Central

    2010-01-01

    Background Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation) are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. Methods/Design The Rochester Patient Navigation Research Program (PNRP) is a National Cancer Institute-sponsored, patient-level randomized trial (RCT) of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews) or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. Discussion This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. Trials Registration clinicaltrials.gov identifier NCT00496678 PMID:20939928

  13. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  14. Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol

    PubMed Central

    Brigden, Amberly; Beasant, Lucy; Hollingworth, William; Metcalfe, Chris; Gaunt, Daisy; Mills, Nicola; Jago, Russell; Crawley, Esther

    2016-01-01

    Introduction Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition, yet there is a limited evidence base for treatment. There is good evidence that graded exercise therapy is moderately effective in adults with CFS/ME, but there is little evidence for the effectiveness, cost-effectiveness, acceptability or best method of delivery for paediatric CFS/ME. This study aims to investigate the acceptability and feasibility of carrying out a multicentre randomised controlled trial investigating the effectiveness of graded exercise therapy compared with activity management for children/teenagers who are mildly or moderately affected with CFS/ME. Methods and analysis 100 paediatric patients (8–17 years) with CFS/ME will be recruited from 3 specialist UK National Health Service (NHS) CFS/ME services (Bath, Cambridge and Newcastle). Patients will be randomised (1:1) to receive either graded exercise therapy or activity management. Feasibility analysis will include the number of young people eligible, approached and consented to the trial; attrition rate and treatment adherence; questionnaire and accelerometer completion rates. Integrated qualitative methods will ascertain perceptions of feasibility and acceptability of recruitment, randomisation and the interventions. All adverse events will be monitored to assess the safety of the trial. Ethics and dissemination The trial has received ethical approval from the National Research Ethics Service (South West—Frenchay 15/SW/0124). Trial registration number ISRCTN23962803; Pre-results. PMID:27377634

  15. Assessment of neonatal rat's activity by the automated registration of the animal entries in the squares of a testing arena.

    PubMed

    Menshanov, Petr N; Dygalo, Nikolay N

    2007-08-30

    Automated registration of neonatal rat entries in the squares of a testing chamber is suggested for the animal locomotion assessment. This method allows detection of paddling and pivoting activities that are not accompanied by forward movement of the animal. The proposed technique is also relatively insensitive to nonlocomotor changes in a pup's body position, such as breathing and shaking, and thus offers a selective detection of locomotor-related activity. The application of the method permits the evaluation of spontaneous and stimulated motor activity of neonatal rats using relatively short test duration and a minimal number of animals.

  16. Sample registration software for process automation in the Neutron Activation Analysis (NAA) Facility in Malaysia nuclear agency

    SciTech Connect

    Rahman, Nur Aira Abd Yussup, Nolida; Ibrahim, Maslina Bt. Mohd; Mokhtar, Mukhlis B.; Soh Shaari, Syirrazie Bin Che; Azman, Azraf B.; Salim, Nazaratul Ashifa Bt. Abdullah; Ismail, Nadiah Binti

    2015-04-29

    Neutron Activation Analysis (NAA) had been established in Nuclear Malaysia since 1980s. Most of the procedures established were done manually including sample registration. The samples were recorded manually in a logbook and given ID number. Then all samples, standards, SRM and blank were recorded on the irradiation vial and several forms prior to irradiation. These manual procedures carried out by the NAA laboratory personnel were time consuming and not efficient. Sample registration software is developed as part of IAEA/CRP project on ‘Development of Process Automation in the Neutron Activation Analysis (NAA) Facility in Malaysia Nuclear Agency (RC17399)’. The objective of the project is to create a pc-based data entry software during sample preparation stage. This is an effective method to replace redundant manual data entries that needs to be completed by laboratory personnel. The software developed will automatically generate sample code for each sample in one batch, create printable registration forms for administration purpose, and store selected parameters that will be passed to sample analysis program. The software is developed by using National Instruments Labview 8.6.

  17. 77 FR 26281 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... from 125 tobacco product establishments annually, for a total 750 hour burden (125 respondents x 1.6 responses per respondent x 3.75 hours per response). FDA estimates that the submission of ingredient listing... hours respondents respondent responses response Form FDA 3742 Registration and 125 1.6 200 3.75...

  18. Registering to Vote Is Easy, Right? Active Learning and Attitudes about Voter Registration

    ERIC Educational Resources Information Center

    Gershtenson, Joseph; Plane, Dennis L.; Scacco, Joshua M.; Thomas, Jerry

    2013-01-01

    In a democracy, agents of political socialization, such as schools and parents, generally emphasize the importance of voting. While college students may be exposed briefly to voter registration as a barrier to participation, there is little evidence that the topic is given serious attention in the classroom. This research addresses how classroom…

  19. 21 CFR 1309.24 - Waiver of registration requirement for certain activities.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS Requirements for... scheduled listed chemical product or other product containing a List I chemical that is described and... listed chemical product or other product containing a List I chemical that is described and included...

  20. Getting our house in order: an audit of the registration and publication of clinical trials supported by the National Institute for Health Research Oxford Biomedical Research Centre and the Musculoskeletal Biomedical Research Unit

    PubMed Central

    Tompson, A C; Petit-Zeman, S; Goldacre, B; Heneghan, C J

    2016-01-01

    Objectives To audit the proportion of clinical trials that had been publically registered and, of the completed trials, the proportion published. Setting 2 major research institutions supported by the National Institute of Health Research (NIHR). Primary and secondary outcome measures The proportion of trials reporting results within 12 months, 24 months and ‘ever’. Factors associated with non-publication were analysed using logistic regression. Inclusion criteria Phases 2–4 clinical trials identified from internal documents and publication lists. Results In total, 286 trials were identified. We could not find registration for 4 (1.4%) of these, all of which were completed and published. Of the trials with a registered completion date pre-January 2015, just over half (56%) were published, and half of these were published within 12 months (36/147, 25%). For some trials, information on the public registers was found to be out-of-date and/or inaccurate. No clinical trial characteristics were found to be significantly associated with non-publication. We have produced resources to facilitate similar audits elsewhere. Conclusions It was feasible to conduct an internal audit of registration and publication in 2 major research institutions. Performance was similar to, or better than, comparable cohorts of trials sampled from registries. The major resource input required was manually seeking information: if all registry entries were maintained, then almost the entire process of audit could be automated—and routinely updated—for all research centres and funders. PMID:26936902

  1. Effect of wrist-worn activity monitor feedback on physical activity behavior: A randomized controlled trial in Finnish young men

    PubMed Central

    Jauho, Anna-Maiju; Pyky, Riitta; Ahola, Riikka; Kangas, Maarit; Virtanen, Paula; Korpelainen, Raija; Jämsä, Timo

    2015-01-01

    The purpose of this study is to evaluate whether the use of an activity monitor providing feedback has an effect on physical activity (PA) in young men. A population-based sample of 276 conscription-aged (mean = 17.9, SD = 0.7 years) men participated in a 3-month randomized controlled trial in Oulu in 2012. Participants were randomized to an intervention group (INT, N = 137) and a control group (CON, N = 139). INT received a wrist-worn monitor (Polar Active) showing daily activity, and CON received identical monitors without feedback. Main outcome was the change from baseline in objectively measured weekly time spent in moderate-to-vigorous PA (MVPA) and sedentary activity (SED), as assessed by generalized estimation equations (GEE). Other lifestyle factors were assessed by a questionnaire at baseline and at 3 months. Weekly physical activity data (≥ 4 days with ≥ 8 h each) were obtained from 72 (53%) and 90 (65%) men in the INT and CON, respectively. Based on GEE, time spent in MVPA increased (p = 0.012) and SED decreased (p = 0.032) in the INT compared with the CON. During the first 7 weeks, the INT spent on average 1 h less sedentary than the CON (t-test, p < 0.05). During the first week, the INT showed 12 minutes more MVPA compared to the CON (t-test, p = 0.034). Based on questionnaire data, the proportion of the most sedentary men decreased in the INT (Wilcoxon test, 28% vs. 10%, p = 0.029), with no change in the CON (20% vs. 19%, p = 0.546). To conclude, a wrist-worn activity monitor providing feedback had a short-term positive effect on PA and SED in young men. Trial registration This is a pilot study for a larger randomized controlled trial registered to the clinical trials register NCT01376986. PMID:26844128

  2. A Short-Term Physical Activity Randomized Trial in the Lower Mississippi Delta

    PubMed Central

    Katzmarzyk, Peter T.; Champagne, Catherine M.; Tudor-Locke, Catrine; Broyles, Stephanie T.; Harsha, David; Kennedy, Betty M.; Johnson, William D.

    2011-01-01

    Background The purpose of this study was to determine if a short-term pedometer-based intervention results in immediate increases in time spent in moderate-to-vigorous physical activity (MVPA) compared to a minimal educational intervention. Methods A sample of 43 overweight adults 35 to 64 years of age participated in a one week pedometer-based feasibility trial monitored by accelerometry. Participants were randomized into a one-week education-only group or a group that also wore a pedometer. Accelerometer-measured MVPA was measured over 7 days at baseline and again for 7 days immediately post-intervention. Results Minutes of MVPA increased significantly in the overall sample (p = 0.02); however, the effect of adding the pedometer to the education program was not significant (p = 0.89). Mean (±SE) MVPA increased from 12.7±2.4 min/day to 16.2±3.6 min/day in the education-only group and from 13.2±3.3 min/day to 16.3±3.9 min/day in the education+pedometer group. The correlation between change in steps/day and change in MVPA was 0.69 (p<0.0001). Conclusions The results of this study suggest that the addition of a pedometer to a short-term education program does not produce added benefits with respect to increasing physical activity in the Lower Mississippi Delta. Trial Registration ClinicalTrials.gov NCT01264757 PMID:22046325

  3. Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility

    PubMed Central

    2014-01-01

    Background The World Wide Web is an effective method for delivering health behavior programs, yet major limitations remain (eg, cost of development, time and resource requirements, limited interactivity). Social media, however, has the potential to deliver highly customizable and socially interactive behavioral interventions with fewer constraints. Thus, the evaluation of social media as a means to influence health behaviors is warranted. Objective The objective of this trial was to examine and demonstrate the feasibility of using an established social networking platform (ie, Facebook) to deliver an 8 week physical activity intervention to a sample of low-active adolescents (N=21; estimated marginal mean age 13.48 years). Methods Participants were randomized to either an experimental (ie, Behavioral) or attentional control (ie, Informational) condition. Both conditions received access to a restricted-access, study-specific Facebook group where the group’s administrator made two daily wall posts containing youth-based physical activity information and resources. Primary outcomes included physical activity as assessed by accelerometry and self-report. Interactions and main effects were examined, as well as mean differences in effect sizes. Results Analyses revealed significant improvements over time on subjectively reported weekly leisure-time physical activity (F 1,18=8.426, P=.009, η2 = .319). However, there was no interaction between time and condition (F 1,18=0.002, P=.968, η2 = .000). There were no significant time or interaction effects among the objectively measured physical activity variables. Examination of effect sizes revealed moderate-to-large changes in physical activity outcomes. Conclusions Results provide initial support for the feasibility of delivery of a physical activity intervention to low-active adolescents via social media. Whether by employing behavioral interventions via social media can result in statistically meaningful changes in

  4. Cross-sectional and longitudinal analysis of cancer vaccination trials registered on the US Clinical Trials Database demonstrates paucity of immunological trial endpoints and decline in registration since 2008

    PubMed Central

    Lu, Liangjian; Yan, Haixi; Shyam-Sundar, Vijay; Janowitz, Tobias

    2014-01-01

    Introduction Cancer vaccination has been researched as a means of treating and preventing cancer, but successful translational efforts yielding clinical therapeutics have been limited. Numerous reasons have been offered in explanation, pertaining both to the vaccine formulation, and the clinical trial methodology used. This study aims to characterize the tumor vaccine clinical trial landscape quantitatively, and explore the possible validity of the offered explanations including the translational obstacles posed by the current common endpoints. Methods We performed a detailed cross-sectional and longitudinal analysis of tumor vaccine trials (n=955) registered in the US Clinical Trials database. Results The number of tumor vaccine trials initiated per annum has declined 30% since a peak in 2008. In terms of vaccine formulation, 25% of trials use tumor cell/lysate preparations; whereas, 73% of trials vaccinate subjects against defined protein/peptide antigens. Also, 68% of trials do not use vectors for antigen delivery. Both these characteristics of tumor vaccines have remained unchanged since 1996. The top five types of cancer studied are: melanoma (22.6%); cervical cancer (13.0%); breast cancer (11.3%); lung cancer (9.5%); and prostate cancer (9.4%). In addition, 86% of the trials are performed where there is established disease rather than prophylactically, of which 67% are performed exclusively in the adjuvant setting. Also, 42% of Phase II trials do not measure any survival-related endpoint, and only 23% of Phase III trials assess the immune response to vaccination. Conclusion The clinical trial effort in tumor vaccination is declining, necessitating a greater urgency in identifying and removing the obstacles to clinical translation. These obstacles may include: 1) vaccination against a small range of antigens; 2) naked delivery of antigen; 3) investigation of less immunogenic cancer types; and 4) investigation in the setting of established disease. In addition

  5. 40 CFR 152.113 - Approval of registration under FIFRA sec. 3(c)(7)-Products that do not contain a new active...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... sec. 3(c)(7)-Products that do not contain a new active ingredient. 152.113 Section 152.113 Protection... FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient. (a) Except as provided in... registration of a pesticide product, each of whose active ingredients is contained in one or more...

  6. 40 CFR 152.113 - Approval of registration under FIFRA sec. 3(c)(7)-Products that do not contain a new active...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... sec. 3(c)(7)-Products that do not contain a new active ingredient. 152.113 Section 152.113 Protection... FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient. (a) Except as provided in... registration of a pesticide product, each of whose active ingredients is contained in one or more...

  7. 40 CFR 152.113 - Approval of registration under FIFRA sec. 3(c)(7)-Products that do not contain a new active...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... sec. 3(c)(7)-Products that do not contain a new active ingredient. 152.113 Section 152.113 Protection... FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient. (a) Except as provided in... registration of a pesticide product, each of whose active ingredients is contained in one or more...

  8. 40 CFR 152.113 - Approval of registration under FIFRA sec. 3(c)(7)-Products that do not contain a new active...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... sec. 3(c)(7)-Products that do not contain a new active ingredient. 152.113 Section 152.113 Protection... FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient. (a) Except as provided in... registration of a pesticide product, each of whose active ingredients is contained in one or more...

  9. Large-scale field trials of active immunizing agents

    PubMed Central

    Cockburn, W. Charles

    1955-01-01

    In this discussion of the methods to be used in large-scale field trials of active immunizing agents and of the results to be expected from such trials, special emphasis is laid on pertussis vaccine trials in Great Britain. After a review of the criteria for strictly controlled field studies and of the investigation of typhoid vaccines conducted in 1904-08 by the Antityphoid Committee of the British Army, the author describes the pertussis vaccine studies which have been and are now being carried by the Whooping-Cough Immunization Committee of the Medical Research Council of Great Britain. The original strictly controlled trials have been completed and the results published. Studies are now being made of vaccines prepared by different methods and evaluated both in the field and in the laboratory. Each vaccine is given to some 2000-3000 children of 4-6 months to 4 years of age. By the end of the studies 30 000-40 000 children will have been followed up for a period of two years. Since in the current studies all the children are vaccinated and none are left as unvaccinated controls, the relative and not the absolute protective value of the vaccines will be measured. PMID:13270079

  10. Active illumination based 3D surface reconstruction and registration for image guided medialization laryngoplasty

    NASA Astrophysics Data System (ADS)

    Jin, Ge; Lee, Sang-Joon; Hahn, James K.; Bielamowicz, Steven; Mittal, Rajat; Walsh, Raymond

    2007-03-01

    The medialization laryngoplasty is a surgical procedure to improve the voice function of the patient with vocal fold paresis and paralysis. An image guided system for the medialization laryngoplasty will help the surgeons to accurately place the implant and thus reduce the failure rates of the surgery. One of the fundamental challenges in image guided system is to accurately register the preoperative radiological data to the intraoperative anatomical structure of the patient. In this paper, we present a combined surface and fiducial based registration method to register the preoperative 3D CT data to the intraoperative surface of larynx. To accurately model the exposed surface area, a structured light based stereo vision technique is used for the surface reconstruction. We combined the gray code pattern and multi-line shifting to generate the intraoperative surface of the larynx. To register the point clouds from the intraoperative stage to the preoperative 3D CT data, a shape priori based ICP method is proposed to quickly register the two surfaces. The proposed approach is capable of tracking the fiducial markers and reconstructing the surface of larynx with no damage to the anatomical structure. We used off-the-shelf digital cameras, LCD projector and rapid 3D prototyper to develop our experimental system. The final RMS error in the registration is less than 1mm.

  11. Accelerometer Use in a Physical Activity Intervention Trial

    PubMed Central

    Borradaile, Kelley E.; Lewis, Beth A.; Whiteley, Jessica A.; Longval, Jaime L.; Parisi, Alfred F.; Albrecht, Anna E.; Sciamanna, Christopher N.; Jakicic, John M.; Papandonatos, George D.; Marcus, Bess H.

    2010-01-01

    This paper describes the application of best practice recommendations for using accelerometers in a physical activity (PA) intervention trial, and the concordance of different methods for measuring PA. A subsample (n=63; 26%) of the 239 healthy, sedentary adults participating in a PA trial (mean age=47.5; 82% women) wore the ActiGraph monitor at all 3 assessment time points. ActiGraph data were compared with self-report (i.e., PA weekly recall and monthly log) and fitness variables. Correlations between the PA recall and ActiGraph for moderate intensity activity ranged from 0.16–0.48 and from 0.28–0.42 for vigorous intensity activity. ActiGraph and fitness [estimated VO2(ml/kg/min)] had correlations of 0.15–0.45. The ActiGraph and weekly self-report were significantly correlated at all time points (correlations ranged from 0.23–0.44). In terms of detecting intervention effects, intervention groups recorded more minutes of at least moderate-intensity PA on the ActiGraph than the control group at 6 months (min=46.47, 95% CI=14.36–78.58), but not at 12 months. Limitations of the study include a small sample size and only 3 days of ActiGraph monitoring. To obtain optimal results with accelerometers in clinical trials, the authors recommend following best practice recommendations: detailed protocols for monitor use, calibration of monitors and validation of data quality, and use of validated equations for analysis. The ActiGraph has modest concordance with other assessment tools and is sensitive to change over time. However, until more information validating the use of accelerometry in clinical trials becomes available, properly administered self-report measures of PA should remain part of the assessment battery. PMID:20723619

  12. Accelerometer use in a physical activity intervention trial.

    PubMed

    Napolitano, Melissa A; Borradaile, Kelley E; Lewis, Beth A; Whiteley, Jessica A; Longval, Jaime L; Parisi, Alfred F; Albrecht, Anna E; Sciamanna, Christopher N; Jakicic, John M; Papandonatos, George D; Marcus, Bess H

    2010-11-01

    This paper describes the application of best practice recommendations for using accelerometers in a physical activity (PA) intervention trial, and the concordance of different methods for measuring PA. A subsample (n = 63; 26%) of the 239 healthy, sedentary adults participating in a PA trial (mean age = 47.5; 82% women) wore the ActiGraph monitor at all 3 assessment time points. ActiGraph data were compared with self-report (i.e., PA weekly recall and monthly log) and fitness variables. Correlations between the PA recall and ActiGraph for moderate intensity activity ranged from 0.16-0.48 and from 0.28-0.42 for vigorous intensity activity. ActiGraph and fitness [estimated VO(2)(ml/kg/min)] had correlations of 0.15-0.45. The ActiGraph and weekly self-report were significantly correlated at all time points (correlations ranged from 0.23 to 0.44). In terms of detecting intervention effects, intervention groups recorded more minutes of at least moderate-intensity PA on the ActiGraph than the control group at 6 months (min = 46.47, 95% CI = 14.36-78.58), but not at 12 months. Limitations of the study include a small sample size and only 3 days of ActiGraph monitoring. To obtain optimal results with accelerometers in clinical trials, the authors recommend following best practice recommendations: detailed protocols for monitor use, calibration of monitors and validation of data quality, and use of validated equations for analysis. The ActiGraph has modest concordance with other assessment tools and is sensitive to change over time. However, until more information validating the use of accelerometry in clinical trials becomes available, properly administered self-report measures of PA should remain part of the assessment battery.

  13. Enhancing Cognitive Abilities with Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial

    PubMed Central

    Hardy, Joseph L.; Nelson, Rolf A.; Thomason, Moriah E.; Sternberg, Daniel A.; Katovich, Kiefer; Farzin, Faraz; Scanlon, Michael

    2015-01-01

    tasks targeted to different cognitive functions can show transfer to a wide range of untrained measures of cognitive performance. Trial Registration ClinicalTrials.gov NCT-02367898 PMID:26333022

  14. Time Regained: When People Stop a Physical Activity Program, How Does Their Time Use Change? A Randomised Controlled Trial

    PubMed Central

    Gomersall, Sjaan; Maher, Carol; English, Coralie; Rowlands, Alex; Olds, Tim

    2015-01-01

    The aim of this study was to investigate how previously inactive adults who had participated in a structured, partly supervised 6-week exercise program restructured their time budgets when the program ended. Using a randomised controlled trial design, 129 previously inactive adults were recruited and randomly allocated to one of three groups: a Moderate or Extensive six-week physical activity intervention (150 and 300 additional minutes of exercise per week, respectively) or a Control group. Additional physical activity was accumulated through both group and individual exercise sessions with a wide range of activities. Use of time and time spent in energy expenditure zones was measured using a computerised 24-h self-report recall instrument, the Multimedia Activity Recall for Children and Adults, and accelerometry at baseline, mid- and end-program and at 3- and 6-months follow up. At final follow up, all significant changes in time use domains had returned to within 20 minutes of baseline levels (Physical Activity 1-2 min/d, Active Transport 3-9 min/d, Self-Care 0-2 min/d, Television/Videogames 13-18 min/d in the Moderate and Extensive group, relative to Controls, respectively, p>0.05). Similarly, all significant changes in time spent in the moderate energy expenditure zone had returned to within 1-3 min/d baseline levels (p>0.05), however time spent in vigorous physical activity according to accelerometry estimates remained elevated, although the changes were small in magnitude (1 min/d in the Moderate and Extensive groups, relative to Controls, p=0.01). The results of this study demonstrate strong recidivist patterns in physical activity, but also in other aspects of time use. In designing and determining the effectiveness of exercise interventions, future studies would benefit from considering the whole profile of time use, rather than focusing on individual activities. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12610000248066 PMID

  15. Impact of Personalised Feedback about Physical Activity on Change in Objectively Measured Physical Activity (the FAB Study): A Randomised Controlled Trial

    PubMed Central

    Godino, Job G.; Watkinson, Clare; Corder, Kirsten; Marteau, Theresa M.; Sutton, Stephen; Sharp, Stephen J.; Griffin, Simon J.; van Sluijs, Esther M. F.

    2013-01-01

    Background Low levels of physical activity are a major public health concern, and interventions to promote physical activity have had limited success. Whether or not personalised feedback about physical activity following objective measurement motivates behaviour change has yet to be rigorously examined. Methods And Findings: In a parallel group, open randomised controlled trial, 466 healthy adults aged 32 to 54 years were recruited from the ongoing population-based Fenland Study (Cambridgeshire, UK). Participants were randomised to receive either no feedback until the end of the trial (control group, n=120) or one of three different types of feedback: simple, visual, or contextualised (intervention groups, n=346). The primary outcome was physical activity (physical activity energy expenditure (PAEE) in kJ/kg/day and average body acceleration (ACC) in m/s2) measured objectively using a combined heart rate monitor and accelerometer (Actiheart®). The main secondary outcomes included self-reported physical activity, intention to increase physical activity, and awareness of physical activity (the agreement between self-rated and objectively measured physical activity). At 8 weeks, 391 (83.9%) participants had complete physical activity data. The intervention had no effect on objectively measured physical activity (PAEE: β=-0.92, 95% CI=-3.50 to 1.66, p=0.48 and ACC: β=0.01, 95% CI=-0.00 to 0.02, p=0.21), self-reported physical activity (β=-0.39, 95% CI=-1.59 to 0.81), or intention to increase physical activity (β=-0.05, 95% CI=-0.22 to 0.11). However, it was associated with an increase in awareness of physical activity (OR=1.74, 95% CI=1.05 to 2.89). Results did not differ according to the type of feedback. Conclusions Personalised feedback about physical activity following objective measurement increased awareness but did not result in changes in physical activity in the short term. Measurement and feedback may have a role in promoting behaviour change but are

  16. Goal-setting intervention in patients with active asthma: protocol for a pilot cluster-randomised controlled trial

    PubMed Central

    2013-01-01

    Background Supporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation. Methods/design A two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff. Trial

  17. Putting Brain Training to the Test in the Workplace: A Randomized, Blinded, Multisite, Active-Controlled Trial

    PubMed Central

    Borness, Catherine; Proudfoot, Judith; Crawford, John; Valenzuela, Michael

    2013-01-01

    Background Cognitive training (CT) is effective at improving cognitive outcomes in children with and without clinical impairment as well as older individuals. Yet whether CT is of any preventative health benefit to working age adults is controversial. Our objective was therefore to investigate the real-world efficacy of CT in the workplace, involving employees from across the working-age spectrum and addressing many of the design issues that have limited trials to date. Methods and Findings 135 white collar employees of a large Australian public sector organization were randomised to either 16 weeks (20 minutes three times per week) of online CT or an active control (AC) program of equal length and structure. Cognitive, wellbeing and productivity outcome measures were analysed across three timepoints: baseline, immediately after training and 6 months post-training. CT effects on cognitive outcomes were limited, even after planned subgroup analyses of cognitive capacity and age. Unexpectedly, we found that our AC condition, which comprised viewing short documentaries about the natural world, had more impact. Compared to the CT group, 6 months after the end of training, those in the AC group experienced a significant increase in their self-reported Quality of Life (Effect Size g = .34 vs −.15; TIME×GROUP p = .003), decrease in stress levels (g = .22 vs −.19; TIME x GROUP p = .03), and overall improvement in Psychological Wellbeing (g = .32 vs −.06; TIME×GROUP p = .02). Conclusions CT does not appear to positively impact cognition or wellbeing amongst white collar office workers; however, short time-out respite activities may have value in the promotion of psychological wellbeing. Given looming challenges to workplace productivity, further work-based interventional research targeting employee mental health is recommended. Trial Registration This trial was registered with the Australian New Zealand Clinical Trials Registry: ACTRN

  18. A smartphone "app"-delivered randomized factorial trial targeting physical activity in adults.

    PubMed

    Fanning, Jason; Roberts, Sarah; Hillman, Charles H; Mullen, Sean P; Ritterband, Lee; McAuley, Edward

    2017-03-02

    Rapid technological development has challenged researchers developing mobile moderate-to-vigorous physical activity (MVPA) interventions. This 12-week randomized factorial intervention aimed to determine the individual and combined impact of a self-monitoring smartphone-app (tracking, feedback, education) and two theory-based modules (goal-setting, points-based feedback) on MVPA, key psychosocial outcomes, and application usage. Adults (N = 116; M age  = 41.38 ± 7.57) received (1) a basic self-monitoring app, (2) the basic app plus goal setting, (3) the basic app plus points-based feedback, or (4) the basic app plus both modules. All individuals increased MVPA by more than 11 daily minutes. Those with points-based feedback demonstrated still higher levels of MVPA and more favorable psychosocial and app usage outcomes across the intervention. Those with access to in-app goal setting had higher levels of app usage relative to those without the component. It is imperative that effective digital intervention "ingredients" are identified, and these findings provide early evidence to this effect. Trial Registration clinicaltrials.gov identifier NCT02592590.

  19. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in

  20. Land- and water-based exercise intervention in women with fibromyalgia: the al-andalus physical activity randomised controlled trial

    PubMed Central

    2012-01-01

    Background The al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes) in women with fibromyalgia. Methods/Design One hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will be randomly assigned to a usual care (control) group (n = 60), a water-based exercise intervention group (n = 60) or a land-based exercise intervention group (n = 60). Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 min each) per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises. We will also study the effect of a detraining period (i.e., 12 weeks with no exercise intervention) on the studied variables. Discussion Our study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia. Trial registration ClinicalTrials.gov ID: NCT

  1. The impact of physical activity on fatigue and quality of life in lung cancer patients: a randomised controlled trial protocol

    PubMed Central

    2012-01-01

    Background People with lung cancer have substantial symptom burden and more unmet needs than the general cancer population. Physical activity (PA) has been shown to positively influence quality of life (QOL), fatigue and daily functioning in the curative treatment of people with breast and colorectal cancers and lung diseases, as well as in palliative settings. A randomised controlled trial (RCT) is needed to determine if lung cancer patients benefit from structured PA intervention. The Physical Activity in Lung Cancer (PAL) trial is designed to evaluate the impact of a 2-month PA intervention on fatigue and QOL in patients with non-resectable lung cancer. Biological mechanisms will also be studied. Methods/design A multi-centre RCT with patients randomised to usual care or a 2-month PA programme, involving supervised PA sessions including a behavioural change component and home-based PA. QOL questionnaires, disease and functional status and body composition will be assessed at baseline, 2, 4 and 6 months follow-up. The primary endpoint is comparative levels of fatigue between the 2 arms. Secondary endpoints include: QOL, functional abilities and physical function. Exploratory endpoints include: anxiety, depression, distress, dyspnoea, PA behaviour, fitness, hospitalisations, survival, cytokines and insulin-like growth factor levels. Discussion This study will provide high-level evidence of the effect of PA programmes on cancer-related fatigue and QOL in patients with advanced lung cancer. If positive, the study has the potential to change care for people with cancer using a simple, inexpensive intervention to improve their QOL and help them maintain independent function for as long as possible. Trial registration Australian New Zealand Clinical Trials Registry No. ACTRN12609000971235 PMID:23216897

  2. 78 FR 64937 - Pesticide Products; Registration Applications for New Active Ingredients

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ....), Avda, Paret del Patriarca 11-B, Ap. 30, 46113 Moncada (Valencia) Spain. Active ingredient: Bacillus.... 30, 46113 Moncada (Valencia) Spain. Active ingredient: Bacillus subtilis strain IAB/BS03....

  3. Effects of Direct Renin Blockade on Renal & Systemic Hemodynamics and on RAAS Activity, in Weight Excess and Hypertension: A Randomized Clinical Trial

    PubMed Central

    Kwakernaak, A. J.; Roksnoer, L. C.; Lambers Heerspink, H. J.; van den Berg-Garrelds, I.; Lochorn, G. A.; van Embden Andres, J. H.; Klijn, M. A.; Kobori, H.; Danser, A. H. J.; Laverman, G. D.; Navis, G. J.

    2017-01-01

    Aim The combination of weight excess and hypertension significantly contributes to cardiovascular risk and progressive kidney damage. An unfavorable renal hemodynamic profile is thought to contribute to this increased risk and may be ameliorated by direct renin inhibition (DRI). The aim of this trial was to assess the effect of DRI on renal and systemic hemodynamics and on RAAS activity, in men with weight excess and hypertension. Methods A randomized, double-blind, cross-over clinical trial to determine the effect of DRI (aliskiren 300 mg/day), with angiotensin converting enzyme inhibition (ACEi; ramipril 10 mg/day) as a positive control, on renal and systemic hemodynamics, and on RAAS activity (n = 15). Results Mean (SEM) Glomerular filtration rate (101 (5) mL/min/1.73m2) remained unaffected by DRI or ACEi. Effective renal plasma flow (ERPF; 301 (14) mL/min/1.73m2) was increased in response to DRI (320 (14) mL/min/1.73m2, P = 0.012) and ACEi (317 (15) mL/min/1.73m2, P = 0.045). Filtration fraction (FF; 34 (0.8)%) was reduced by DRI only (32 (0.7)%, P = 0.044). Mean arterial pressure (109 (2) mmHg) was reduced by DRI (101 (2) mmHg, P = 0.008) and ACEi (103 (3) mmHg, P = 0.037). RAAS activity was reduced by DRI and ACEi. Albuminuria (20 [9–42] mg/d) was reduced by DRI only (12 [5–28] mg/d, P = 0.030). Conclusions In men with weight excess and hypertension, DRI and ACEi improved renal and systemic hemodynamics. Both DRI and ACEi reduced RAAS activity. Thus, DRI provides effective treatment in weight excess and hypertension. Trial Registration Dutch trial register, registration number: 2532 www.trialregister.nl PMID:28118402

  4. Efficacy and causal mechanism of an online social media intervention to increase physical activity: Results of a randomized controlled trial

    PubMed Central

    Zhang, Jingwen; Brackbill, Devon; Yang, Sijia; Centola, Damon

    2015-01-01

    Objective: To identify what features of social media – promotional messaging or peer networks – can increase physical activity. Method: A 13-week social media-based exercise program was conducted at a large Northeastern university in Philadelphia, PA. In a randomized controlled trial, 217 graduate students from the University were randomized to three conditions: a control condition with a basic online program for enrolling in weekly exercise classes led by instructors of the University for 13 weeks, a media condition that supplemented the basic program with weekly online promotional media messages that encourage physical activity, and a social condition that replaced the media content with an online network of four to six anonymous peers composed of other participants of the program, in which each participant was able to see their peers' progress in enrolling in classes. The primary outcome was the number of enrollments in exercise classes, and the secondary outcomes were self-reported physical activities. Data were collected in 2014. Results: Participants enrolled in 5.5 classes on average. Compared with enrollment in the control condition (mean = 4.5), promotional messages moderately increased enrollment (mean = 5.7, p = 0.08), while anonymous social networks significantly increased enrollment (mean = 6.3, p = 0.02). By the end of the program, participants in the social condition reported exercising moderately for an additional 1.6 days each week compared with the baseline, which was significantly more than an additional 0.8 days in the control condition. Conclusion: Social influence from anonymous online peers was more successful than promotional messages for improving physical activity. Clinical Trial Registration: ClinicalTrials.gov: NCT02267369. PMID:26844132

  5. Physical activity counseling in overweight and obese primary care patients: Outcomes of the VA-STRIDE randomized controlled trial

    PubMed Central

    Gao, Shasha; Stone, Roslyn A.; Hough, Linda J.; Haibach, Jeffrey P.; Marcus, Bess H.; Ciccolo, Joseph T.; Kriska, Andrea M.; Burkitt, Kelly H.; Steenkiste, Ann R.; Berger, Marie A.; Sevick, Mary A.

    2015-01-01

    The purpose of this 2-arm randomized clinical trial was to evaluate the effectiveness of a 12-month, expert system-based, print-delivered physical activity intervention in a primary care Veteran population in Pittsburgh, Pennsylvania. Participants were not excluded for many health conditions that typically are exclusionary criteria in physical activity trials. The primary outcome measures were physical activity reported using the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire and an accelerometer-based activity assessment at baseline, 6, and 12 months. Of the 232 Veterans enrolled in the study, 208 (89.7%) were retained at the 6-month follow-up and 203 (87.5%) were retained at 12 months. Compared to the attention control, intervention participants had significantly increased odds of meeting the U.S. recommended guideline of ≥ 150 min/week of at least moderate-intensity physical activity at 12 months for the modified CHAMPS (odds ratio [OR] = 2.86; 95% CI: 1.03–7.96; p = 0.04) but not at 6 months (OR = 1.54; 95% CI: 0.56–4.23; p = 0.40). Based on accelerometer data, intervention participants had significantly increased odds of meeting ≥ 150 min/week of moderate-equivalent physical activity at 6 months (OR = 6.26; 95% CI: 1.26–31.22; p = 0.03) and borderline significantly increased odds at 12 months (OR = 4.73; 95% CI: 0.98–22.76; p = 0.053). An expert system physical activity counseling intervention can increase or sustain the proportion of Veterans in primary care meeting current recommendations for moderate-intensity physical activity. Trial Registration Clinical trials.gov identifier: NCT00731094 URL: http://www.clinicaltrials.gov/ct2/show/NCT00731094. PMID:26844197

  6. Feasibility study and pilot cluster-randomised controlled trial of the GoActive intervention aiming to promote physical activity among adolescents: outcomes and lessons learnt

    PubMed Central

    Corder, Kirsten; Brown, Helen E; Schiff, Annie; van Sluijs, Esther M F

    2016-01-01

    .8 (0.1 to 3.4) p=0.04 but no difference in shyness/sociability. Participation in activity types approached significance (intervention group 2.3 (−0.2 to 4.7) p=0.07 more activity types). Conclusions Results suggest feasibility and indicate potential effectiveness of GoActive to increase MVPA and support a fully powered evaluation of effectiveness and cost-effectiveness. Process evaluation data were used to refine GoActive prior to a full trial. Trial registration number ISRCTN31583496; pre-results. PMID:27836873

  7. Activation of axonal Kv7 channels in human peripheral nerve by flupirtine but not placebo - therapeutic potential for peripheral neuropathies: results of a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Flupirtine is an analgesic with muscle-relaxing properties that activates Kv7 potassium channels. Kv7 channels are expressed along myelinated and unmyelinated peripheral axons where their activation is expected to reduce axonal excitability and potentially contribute to flupirtine’s clinical profile. Trial design To investigate the electrical excitability of peripheral myelinated axons following orally administered flupirtine, in-vitro experiments on isolated peripheral nerve segments were combined with a randomised, double-blind, placebo-controlled, phase I clinical trial (RCT). Methods Threshold tracking was used to assess the electrical excitability of myelinated axons in isolated segments of human sural nerve in vitro and motoneurones to abductor pollicis brevis (APB) in situ in healthy subjects. In addition, the effect of flupirtine on ectopic action potential generation in myelinated axons was examined using ischemia of the lower arm. Results Flupirtine (3-30 μM) shortened the relative refractory period and increased post-conditioned superexcitability in human myelinated axons in vitro. Similarly, in healthy subjects the relative refractory period of motoneurones to APB was reduced 2 hours after oral flupirtine but not following placebo. Whether this effect was due to a direct action of flupirtine on peripheral axons or temperature could not be resolved. Flupirtine (200 mg p.o.) also reduced ectopic axonal activity induced by 10 minutes of lower arm ischemia. In particular, high frequency (ca. 200 Hz) components of EMG were reduced in the post-ischemic period. Finally, visual analogue scale ratings of sensations perceived during the post-ischemic period were reduced following flupirtine (200 mg p.o.). Conclusions Clinical doses of flupirtine reduce the excitability of peripheral myelinated axons. Trial registration ClinicalTrials registration is NCT01450865. PMID:23394517

  8. Improving transparency of clinical trials.

    PubMed

    Dal-Ré, Rafael

    2015-06-01

    Recent data reveal that subtle selective publication affects critical aspects of trial reporting, in some cases altering the interpretation of results. Timely prospective registration could help deter selective reporting and clinical trial stakeholders from government authorities to journal editors should work together to foster prospective registration of trials.

  9. 31 CFR 538.521 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... organizations involved in humanitarian or religious activities in Sudan, authorizing transactions by such... technology to Sudan and the transfer of funds to and from Sudan for the purpose of relieving human...

  10. 31 CFR 538.521 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... organizations involved in humanitarian or religious activities in Sudan, authorizing transactions by such... technology to Sudan and the transfer of funds to and from Sudan for the purpose of relieving human...

  11. 31 CFR 538.521 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... organizations involved in humanitarian or religious activities in Sudan, authorizing transactions by such... technology to Sudan and the transfer of funds to and from Sudan for the purpose of relieving human...

  12. 31 CFR 538.521 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... organizations involved in humanitarian or religious activities in Sudan, authorizing transactions by such... technology to Sudan and the transfer of funds to and from Sudan for the purpose of relieving human...

  13. 31 CFR 538.521 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... organizations involved in humanitarian or religious activities in Sudan, authorizing transactions by such... technology to Sudan and the transfer of funds to and from Sudan for the purpose of relieving human...

  14. 78 FR 70043 - Pesticide Product Registration; Receipt of an Application for a New Active Ingredient

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... name: DAS-81419-2 Soybean. Active ingredients: Bacillus thuringiensis Cry1Ac protein expressed in soybean and Bacillus thuringiensis Cry1F protein expressed in soybean. Proposed classification/Use:...

  15. 76 FR 65730 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... of current labeling and a sampling of advertisements, a quantitative listing of the active ingredient... also require, under Sec. 207.31, a copy of all advertisements and a quantitative listing of...

  16. 31 CFR 545.511 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... TREASURY TALIBAN (AFGHANISTAN) SANCTIONS REGULATIONS Licenses, Authorizations and Statements of Licensing... nongovernmental organizations involved in humanitarian or religious activities in the territory of Afghanistan..., including the exportation of goods, software, technology or services to the territory of...

  17. Exercise improves quality of life in bariatric surgery candidates: Results from the Bari-Active trial

    PubMed Central

    Bond, Dale S.; Thomas, J. Graham; King, Wendy C.; Vithiananthan, Sivamainthan; Trautvetter, Jennifer; Unick, Jessica L.; Ryder, Beth A.; Pohl, Dieter; Roye, G. Dean; Sax, Harry C.; Wing, Rena R.

    2014-01-01

    OBJECTIVE To examine the impact of a pre-bariatric surgery physical activity intervention (PAI), designed to increase bout-related (≥10-minute) moderate-to-vigorous PA (MVPA), on health-related quality of life (HRQoL). METHODS Analyses included 75 adult participants (86.7% female; BMI=45.0±6.5 kg/m2) who were randomly assigned to 6 weeks of PAI (n=40) or standard pre-surgical care (SC; n=35). PAI received six individual weekly counseling sessions to increase walking exercise. Participants wore an objective PA monitor for 7 days and completed the SF-36 Health Survey at baseline and post-intervention to evaluate bout-related MVPA and HRQoL changes, respectively. RESULTS PAI increased bout-related MVPA from baseline to post-intervention (4.4±5.5 to 21.0±21.4 minutes/day) versus no change (7.9±16.6 to 7.6±11.5 minutes/day) for SC (p=0.001). PAI reported greater improvements than SC on all SF-36 physical and mental scales (p<0.05), except role-emotional. In PAI, better baseline scores on the physical function and general health scales predicted greater bout-related MVPA increases (p<0.05), and greater bout-related MVPA increases were associated with greater post-intervention improvements on the physical function, bodily pain, and general health scales (p<0.05). CONCLUSIONS Increasing PA preoperatively improves physical and mental HRQoL in bariatric surgery candidates. Future studies should examine whether this effect improves surgical safety, weight loss outcomes, and postoperative HRQoL. Trial Registration clinicaltrials.gov Identifier: NCT00962325 PMID:25611582

  18. 75 FR 5581 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-03

    ... you provide. 5. Offer alternative ways to improve the collection activity. 6. Make sure to submit your comments by the deadline identified under DATES. ] 7. To ensure proper receipt by EPA, be sure to identify... collection of information; search data sources; complete and review the collection of information;...

  19. The cameroon mobile phone sms (CAMPS) trial: a protocol for a randomized controlled trial of mobile phone text messaging versus usual care for improving adherence to highly active anti-retroviral therapy

    PubMed Central

    2011-01-01

    Background This trial aims at testing the efficacy of weekly reminder and motivational text messages, compared to usual care in improving adherence to Highly Active Antiretroviral Treatment in patients attending a clinic in Yaoundé, Cameroon. Methods and Design This is a single-centered randomized controlled single-blinded trial. A central computer generated randomization list will be generated using random block sizes. Allocation will be determined by sequentially numbered sealed opaque envelopes. 198 participants will either receive the mobile phone text message or usual care. Our hypothesis is that weekly motivational text messages can improve adherence to Highly Active Antiretroviral Treatment and other clinical outcomes in the control group by acting as a reminder, a cue to action and opening communication channels. Data will be collected at baseline, three months and six months. A blinded program secretary will send out text messages and record delivery. Our primary outcomes are adherence measured by the visual analogue scale, self report, and pharmacy refill data. Our secondary outcomes are clinical: weight, body mass index, opportunistic infections, all cause mortality and retention; biological: Cluster Designation 4 count and viral load; and quality of life. Analysis will be by intention-to-treat. Covariates and subgroups will be taken into account. Discussion This trial investigates the potential of SMS motivational reminders to improve adherence to Highly Active Antiretroviral Treatment in Cameroon. The intervention targets non-adherence due to forgetfulness and other forms of non-adherence. Trial Registration Pan-African Clinical Trials Registry PACTR201011000261458 http://clinicaltrials.gov/ NCT01247181 PMID:21211064

  20. 28 CFR 10.2 - Language of registration statement.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Language of registration statement. 10.2... ON ACTIVITIES WITHIN THE UNITED STATES Registration Statement § 10.2 Language of registration statement. Registration statements must be in English if possible. If in a foreign language they must...

  1. 28 CFR 10.2 - Language of registration statement.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Language of registration statement. 10.2... ON ACTIVITIES WITHIN THE UNITED STATES Registration Statement § 10.2 Language of registration statement. Registration statements must be in English if possible. If in a foreign language they must...

  2. 28 CFR 10.2 - Language of registration statement.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Language of registration statement. 10.2... ON ACTIVITIES WITHIN THE UNITED STATES Registration Statement § 10.2 Language of registration statement. Registration statements must be in English if possible. If in a foreign language they must...

  3. 40 CFR 167.20 - Establishments requiring registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Establishments requiring registration... PROGRAMS REGISTRATION OF PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS Registration Requirements § 167.20 Establishments requiring registration. (a) Who must...

  4. 40 CFR 167.20 - Establishments requiring registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Establishments requiring registration... PROGRAMS REGISTRATION OF PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS Registration Requirements § 167.20 Establishments requiring registration. (a) Who must...

  5. 28 CFR 10.1 - Form of registration statement.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Form of registration statement. 10.1 Section 10.1 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN ORGANIZATIONS CARRYING ON ACTIVITIES WITHIN THE UNITED STATES Registration Statement § 10.1 Form of registration...

  6. An Adaptive Physical Activity Intervention for Overweight Adults: A Randomized Controlled Trial

    PubMed Central

    Adams, Marc A.; Sallis, James F.; Norman, Gregory J.; Hovell, Melbourne F.; Hekler, Eric B.; Perata, Elyse

    2013-01-01

    intervention outperformed the static intervention for increasing PA. The adaptive goal and feedback algorithm is a “behavior change technology” that could be incorporated into mHealth technologies and scaled to reach large populations. Trial Registration ClinicalTrials.gov NCT01793064 PMID:24349392

  7. Effect of Darapladib Treatment on Endarterectomy Carotid Plaque Lipoprotein-Associated Phospholipase A2 Activity: A Randomized, Controlled Trial

    PubMed Central

    Johnson, Joel L.; Shi, Yi; Snipes, Rose; Janmohamed, Salim; Rolfe, Timothy E.; Davis, Bill; Postle, Anthony; Macphee, Colin H.

    2014-01-01

    Background The aim of this study was to assess the effects of darapladib, a selective oral investigational lipoprotein-associated phospholipase A2 inhibitor, on both plasma and plaque lipoprotein-associated phospholipase A2 activity. Methods Patients undergoing elective carotid endarterectomy were randomized to darapladib 40 mg (n = 34), 80 mg (n = 34), or placebo (n = 34) for 14 days, followed by carotid endarterectomy 24 hours after the last dose of study medication. Results Darapladib 40 mg and 80 mg reduced plasma lipoprotein-associated phospholipase A2 activity by 52% and 81%, respectively, versus placebo (both P<0.001). Significant reductions in plaque lipoprotein-associated phospholipase A2 activity were also observed compared with placebo (P<0.0001), which equated to a 52% and 80% decrease compared with placebo. No significant differences were observed between groups in plaque lysophosphatidylcholine content or other biomarkers, although a dose-dependent decrease in plaque matrix metalloproteinase-9 mRNA expression was observed with darapladib 80 mg (P = 0.053 vs placebo). In a post-hoc analysis, plaque caspase-3 (P<0.001) and caspase-8 (P<0.05) activity were found to be significantly lower in the darapladib 80-mg group versus placebo. No major safety concerns were identified in the study. Conclusions Short-term treatment (14±4 days) with darapladib produced a robust, dose-dependent reduction in plasma lipoprotein-associated phospholipase A2 activity. More importantly, darapladib demonstrated placebo-corrected reductions in carotid plaque lipoprotein-associated phospholipase A2 activity of similar magnitude. Darapladib was generally well tolerated and no safety concerns were identified. Additional studies of longer duration are needed to explore whether these pharmacodynamic effects are associated with improved clinical outcomes, as might be hypothesized. Trial Registration Information Name of Registry 1: ClinicalTrials.gov Registry Number

  8. An Internet-Based Physical Activity Intervention to Improve Quality of Life of Inactive Older Adults: A Randomized Controlled Trial

    PubMed Central

    Broekhuizen, Karen; de Gelder, Jelle; Wijsman, Carolien A; Wijsman, Liselotte W; Westendorp, Rudi GJ; Verhagen, Evert; Slagboom, Pieternella E; van Mechelen, Willem; van Heemst, Diana; van der Ouderaa, Frans

    2016-01-01

    -to-vigorous physical activity (MVPA) and increase in quality of life. Conclusions Our study shows that an Internet-based physical activity program was effective in improving quality of life in 60-70-year-olds after 3 months, particularly in participants that reached their individually targeted increase in daily physical activity. Trial Registration Nederlands Trial Register: NTR 3045; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 (Archived by WebCite at http://www.webcitation.org/6fobg2sjJ) PMID:27122359

  9. Active Inference, epistemic value, and vicarious trial and error

    PubMed Central

    Cartoni, Emilio; Rigoli, Francesco; Pio-Lopez, Léo; Friston, Karl

    2016-01-01

    Balancing habitual and deliberate forms of choice entails a comparison of their respective merits—the former being faster but inflexible, and the latter slower but more versatile. Here, we show that arbitration between these two forms of control can be derived from first principles within an Active Inference scheme. We illustrate our arguments with simulations that reproduce rodent spatial decisions in T-mazes. In this context, deliberation has been associated with vicarious trial and error (VTE) behavior (i.e., the fact that rodents sometimes stop at decision points as if deliberating between choice alternatives), whose neurophysiological correlates are “forward sweeps” of hippocampal place cells in the arms of the maze under consideration. Crucially, forward sweeps arise early in learning and disappear shortly after, marking a transition from deliberative to habitual choice. Our simulations show that this transition emerges as the optimal solution to the trade-off between policies that maximize reward or extrinsic value (habitual policies) and those that also consider the epistemic value of exploratory behavior (deliberative or epistemic policies)—the latter requiring VTE and the retrieval of episodic information via forward sweeps. We thus offer a novel perspective on the optimality principles that engender forward sweeps and VTE, and on their role on deliberate choice. PMID:27317193

  10. Analysis of registered cancer clinical trials in Latin America and the Caribbean, 2007-2013.

    PubMed

    Lee, Bridget; Cuervo, Luis G; Rodríguez-Feria, Pablo; Luciani, Silvana

    2016-02-01

    Objective To characterize cancer clinical trials in Latin America and the Caribbean (LAC), with a focus on registration and enrollment trends. Methods Data were collected from 1 285 active cancer clinical trials registered up until 31 May 2014 in the World Health Organization's International Clinical Trial Registry Platform (ICTRP). The trials were categorized by six characteristics of the continuum of cancer control and care: 1) control and planning, 2) prevention, 3) detection and screening, 4) diagnosis, 5) treatment, and 6) survivorship and palliative care. The search strategy protocol included the use of optimized keywords combined with the names of the 43 countries selected for a descriptive analysis. Results A total of 973 registered and 972 enrolled cancer clinical trials between January 2007 and December 2013 were identified. Trends of growth were observed for both registration and enrollment of cancer treatment clinical trials; for other types of cancer clinical trials, trends for registration and enrollment varied in direction. Conclusions Growth trends in the registration of cancer treatment clinical trials indicate incremental adherence to cancer research reporting and improvements in cancer research transparency. The higher proportion of cancer treatment trials versus other types of cancer clinical trials indicates an imbalance in cancer research in the LAC region and suggests the need for more funding and incentives for other areas of research in order to achieve a more comprehensive approach to gaining knowledge on cancer issues.

  11. Apps for IMproving FITness and Increasing Physical Activity Among Young People: The AIMFIT Pragmatic Randomized Controlled Trial

    PubMed Central

    Jiang, Yannan; Whittaker, Robyn; Maddison, Ralph

    2015-01-01

    app intervention (n=16), or the control group (n=18). The mean age of participants was 15.7 (SD 1.2) years; participants were mostly NZ Europeans (61%, 31/51) and 57% (29/51) were female. Overall retention rate was 96% (49/51). There was no significant intervention effect on the primary outcome using either of the apps. Compared to the control, time to complete the fitness test was –28.4 seconds shorter (95% CI –66.5 to 9.82, P=.20) for the immersive app group and –24.7 seconds (95% CI –63.5 to 14.2, P=.32) for the nonimmersive app group. No significant intervention effects were found for secondary outcomes. Conclusions Although apps have the ability to increase reach at a low cost, our pragmatic approach using readily available commercial apps as a stand-alone instrument did not have a significant effect on fitness. However, interest in future use of PA apps is promising and highlights a potentially important role of these tools in a multifaceted approach to increase fitness, promote PA, and consequently reduce the adverse health outcomes associated with insufficient activity. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12613001030763; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12613001030763 (Archived by WebCite at http://www.webcitation.org/6aasfJVTJ). PMID:26316499

  12. Testing Activity Monitors’ Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients

    PubMed Central

    Ottenbacher, Kenneth J; Fisher, Steve R; Jennings, Kristofer; Brown, Arleen F; Swartz, Maria C; Lyons, Elizabeth J

    2016-01-01

    Background Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users. Objective The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Methods Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders. Results The study started recruitment in October 2015 and is scheduled to be completed by October 2016. Conclusions This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level. Trial Registration ClinicalTrails.gov NCT02554435; https://clinicaltrials.gov/ct2/show/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT) PMID:27129602

  13. Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial

    PubMed Central

    Wade, Julia; Holding, Peter N; Bonnington, Susan; Rooshenas, Leila; Lane, J Athene; Salter, C Elizabeth; Tilling, Kate; Speakman, Mark J; Brewster, Simon F; Evans, Simon; Neal, David E; Hamdy, Freddie C; Donovan, Jenny L

    2015-01-01

    Objectives To develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial. Design Interviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability. Setting Nurse-led clinics were established in 9 centres in the ProtecT trial and compared with 3 non-ProtecT urology centres elsewhere in UK. Participants Within ProtecT, 22 men receiving AM nurse-led care were interviewed about experiences of care; 11 urologists and 23 research nurses delivering ProtecT trial care completed a questionnaire about its acceptability; 20 men managed in urology clinics elsewhere in the UK were interviewed about models of AS/AM care; 12 urologists and three specialist nurses working in these clinics were also interviewed about management of AS/AM. Results Nurse-led care was commended by ProtecT trial participants, who valued the flexibility, accessibility and continuity of the service and felt confident about the quality of care. ProtecT consultant urologists and nurses also rated it highly, identifying continuity of care and resource savings as key attributes. Clinicians and patients outside the ProtecT trial believed that nurse-led care could relieve pressure on urology clinics without compromising patient care. Conclusions The ProtecT AM nurse-led model of care was acceptable to men with localised prostate cancer and clinical specialists in urology. The protocol is available for implementation; we aim to evaluate its impact on routine clinical practice. Trial registration numbers NCT02044172; ISRCTN20141297. PMID:26384727

  14. Study of Mental Activity and Regular Training (SMART) in at risk individuals: A randomised double blind, sham controlled, longitudinal trial

    PubMed Central

    2011-01-01

    Background The extent to which mental and physical exercise may slow cognitive decline in adults with early signs of cognitive impairment is unknown. This article provides the rationale and methodology of the first trial to investigate the isolated and combined effects of cognitive training (CT) and progressive resistance training (PRT) on general cognitive function and functional independence in older adults with early cognitive impairment: Study of Mental and Regular Training (SMART). Our secondary aim is to quantify the differential adaptations to these interventions in terms of brain morphology and function, cardiovascular and metabolic function, exercise capacity, psychological state and body composition, to identify the potential mechanisms of benefit and broader health status effects. Methods SMART is a double-blind randomized, double sham-controlled trial. One hundred and thirty-two community-dwelling volunteers will be recruited. Primary inclusion criteria are: at risk for cognitive decline as defined by neuropsychology assessment, low physical activity levels, stable disease, and age over 55 years. The two active interventions are computerized CT and whole body, high intensity PRT. The two sham interventions are educational videos and seated calisthenics. Participants are randomized into 1 of 4 supervised training groups (2 d/wk × 6 mo) in a fully factorial design. Primary outcomes measured at baseline, 6, and 18 months are the Alzheimer's Disease Assessment Scale (ADAS-Cog), neuropsychological test scores, and Bayer Informant Instrumental Activities of Daily Living (B-IADLs). Secondary outcomes are psychological well-being, quality of life, cardiovascular and musculoskeletal function, body composition, insulin resistance, systemic inflammation and anabolic/neurotrophic hormones, and brain morphology and function via Magnetic Resonance Imaging (MRI) and Spectroscopy (fMRS). Discussion SMART will provide a novel evaluation of the immediate and long term

  15. The effectiveness of physical activity monitoring and distance counselling in an occupational health setting - a research protocol for a randomised controlled trial (CoAct)

    PubMed Central

    2009-01-01

    Background The CoAct (Cocreating Activity) study is investigating a novel lifestyle intervention, aimed at the working population, with daily activity monitoring and distance counselling via telephone and secure web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle counselling on the level of physical activity in an occupational health setting. The purposes include also analysing the potential effects of changes in physical activity on productivity at work and sickness absence, and healthcare costs. This article describes the design of the study and the participant flow until and including randomization. Methods/Design CoAct is a randomised controlled trial with two arms: a control group and intervention group with daily activity monitoring and distance counselling. The intervention focuses on lifestyle modification and takes 12 months. The study population consists of volunteers from 1100 eligible employees of a Finnish insurance company. The primary outcomes of this study are change in physical activity measured in MET minutes per week, work productivity and sickness absence, and healthcare utilisation. Secondary outcomes include various physiological measures. Cost-effectiveness analysis will also be performed. The outcomes will be measured by questionnaires at baseline, after 6, 12, and 24 months, and sickness absence will be obtained from the employer's registers. Discussion No trials are yet available that have evaluated the effectiveness of daily physical activity monitoring and distance counselling in an occupational health setting over a 12 month period and no data on cost-effectiveness of such intervention are available. Trial Registration ClinicalTrials.gov identifier: NCT00994565 PMID:20043831

  16. Use of pedometer-driven walking to promote physical activity and improve health-related quality of life among meat processing workers: a feasibility trial

    PubMed Central

    2013-01-01

    Background Current evidence supports the use of pedometers as effective motivational tools to promote physical activity and improve health-related quality of life in the general population. The aims of this study are to examine whether a pedometer-driven walking programme can improve health-related quality of life, and increase ambulatory activity in a population of meat processing workers when compared to a control group receiving educational material alone. Methods/design A feasibility study employing a randomized controlled trial (RCT) design will collect data at three time points. A sample of up to 60 meat workers will be recruited and randomly assigned to either an intervention group N = 30 (12-week pedometer-driven walking program, brief intervention, and educational material), or control group N = 30 (educational material only). The primary outcomes of ambulatory activity, health-related quality of life, and functional capacity, will be evaluated at baseline, immediately following the 12-week intervention and then at three month post-intervention. Discussion This paper describes the design of a feasibility randomized controlled trial, which aims to assess the effectiveness of the introduction of a workplace pedometer-driven walking program compared to normal lifestyle advice in meat processing workers. Trial Registration Number (ANZCTR): 12613000087752. PMID:24175980

  17. Trial Burn Activities for a Mixed Waste Incinerator

    SciTech Connect

    Birk, M.B.

    1998-05-01

    The Consolidated Incineration Facility (CIF) is located on the Savannah River Site (SRS), owned by the U. S. Department of Energy and managed by BNFL, Inc. for the Westinghouse Savannah River Company. SRS received permits from the South Carolina Department of Health and Environmental Control (SCDHEC) and the U. S. Environmental Protection Agency (EPA), Region IV to construct and operate the CIF, a hazardous, radioactive mixed waste incinerator. This paper presents the results of the trial burn conducted on the CIF in April 1997 which is the initial demonstration of compliance with the permits. The incinerator is currently operating under approved post-trial burn conditions while the trial burn results are being evaluated. A final operating permit is expected the fall of 1998.

  18. Parent-Targeted Mobile Phone Intervention to Increase Physical Activity in Sedentary Children: Randomized Pilot Trial

    PubMed Central

    Marker, Arwen M; Allen, H Raymond; Machtmes, Ryan; Han, Hongmei; Johnson, William D; Schuna Jr, John M; Broyles, Stephanie T; Tudor-Locke, Catrine; Church, Timothy S

    2014-01-01

    2 months of the study (P=.002). Children in both the MIG and IIG significantly increased their physical activity, averaged over 12 weeks, by 1427.6 (SD 583.0; P=.02) and 2832.8 (SD 604.9; P<.001) steps/day above baseline, respectively. The between group difference was not statistically significant (P=.10; effect size=.40), nor was the group by time interaction (P=.57). Regardless of group assignment, children who significantly increased their physical activity reported greater increases in physical activity enjoyment (P=.003). The number of behavioral articles accessed by IIG parents was significantly correlated with change in children’s steps/day (r=.575, P=.04). Changes in children’s steps/day were unrelated to changes in their body composition, mood, and food intake. Conclusions Parent-targeted mobile phone interventions are feasible, yet more intense interventions may be needed to support parents’ efforts to increase their children’s physical activity to levels that approximate national recommendations. Trial Registration Clinicaltrials.gov NCT01551108; http://clinicaltrials.gov/show/NCT01551108 (Archived by WebCite at http://www.webcitation.org/6TNEOzXNX). PMID:25386899

  19. ACTIVE: A Cognitive Intervention Trial to Promote Independence in Older Adults

    PubMed Central

    Jobe, Jared B.; Smith, David M.; Ball, Karlene; Tennstedt, Sharon L.; Marsiske, Michael; Willis, Sherry L.; Rebok, George W.; Morris, John N.; Helmers, Karin F.; Leveck, Mary D.; Kleinman, Ken

    2010-01-01

    The Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) trial is a randomized, controlled, single-masked trial designed to determine whether cognitive training interventions (memory, reasoning, and speed of information processing), which have previously been found to be successful at improving mental abilities under laboratory or small-scale field conditions, can affect cognitively based measures of daily functioning. Enrollment began during 1998; 2-year follow-up will be completed by January 2002. Primary outcomes focus on measures of cognitively demanding everyday functioning, including financial management, food preparation, medication use, and driving. Secondary outcomes include health-related quality of life, mobility, and health-service utilization. Trial participants (n = 2832) are aged 65 and over, and at entry into the trial, did not have significant cognitive, physical, or functional decline. Because of its size and the carefully developed rigor, ACTIVE may serve as a guide for future behavioral medicine trials of this nature. PMID:11514044

  20. Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: a protocol for the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial

    PubMed Central

    Hassett, Leanne; van den Berg, Maayken; Lindley, Richard I; Crotty, Maria; McCluskey, Annie; van der Ploeg, Hidde P; Smith, Stuart T; Schurr, Karl; Killington, Maggie; Bongers, Bert; Howard, Kirsten; Heritier, Stephane; Togher, Leanne; Hackett, Maree; Treacy, Daniel; Dorsch, Simone; Wong, Siobhan; Scrivener, Katharine; Chagpar, Sakina; Weber, Heather; Pearson, Ross; Sherrington, Catherine

    2016-01-01

    Introduction People with mobility limitations can benefit from rehabilitation programmes that provide a high dose of exercise. However, since providing a high dose of exercise is logistically challenging and resource-intensive, people in rehabilitation spend most of the day inactive. This trial aims to evaluate the effect of the addition of affordable technology to usual care on physical activity and mobility in people with mobility limitations admitted to inpatient aged and neurological rehabilitation units compared to usual care alone. Methods and analysis A pragmatic, assessor blinded, parallel-group randomised trial recruiting 300 consenting rehabilitation patients with reduced mobility will be conducted. Participants will be individually randomised to intervention or control groups. The intervention group will receive technology-based exercise to target mobility and physical activity problems for 6 months. The technology will include the use of video and computer games/exercises and tablet applications as well as activity monitors. The control group will not receive any additional intervention and both groups will receive usual inpatient and outpatient rehabilitation care over the 6-month study period. The coprimary outcomes will be objectively assessed physical activity (proportion of the day spent upright) and mobility (Short Physical Performance Battery) at 6 months after randomisation. Secondary outcomes will include: self-reported and objectively assessed physical activity, mobility, cognition, activity performance and participation, utility-based quality of life, balance confidence, technology self-efficacy, falls and service utilisation. Linear models will assess the effect of group allocation for each continuously scored outcome measure with baseline scores entered as a covariate. Fall rates between groups will be compared using negative binomial regression. Primary analyses will be preplanned, conducted while masked to group allocation and use an

  1. 75 FR 34115 - Pesticides; Availability of Updated Schedule for Registration Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-16

    ... to reregistration is the registration date of the first product containing the active ingredient... AGENCY Pesticides; Availability of Updated Schedule for Registration Review AGENCY: Environmental... for the pesticide registration review program, the periodic review of all registered...

  2. An Interactive Computer Session to Initiate Physical Activity in Sedentary Cardiac Patients: Randomized Controlled Trial

    PubMed Central

    Smith-Ray, Renae L; Dzewaltowski, David A; Glasgow, Russell E; Lee, Rebecca E; Thomas, Deborah SK; Xu, Stanley; Estabrooks, Paul A

    2015-01-01

    Background Physical activity (PA) improves many facets of health. Despite this, the majority of American adults are insufficiently active. Adults who visit a physician complaining of chest pain and related cardiovascular symptoms are often referred for further testing. However, when this testing does not reveal an underlying disease or pathology, patients typically receive no additional standard care services. A PA intervention delivered within the clinic setting may be an effective strategy for improving the health of this population at a time when they may be motivated to take preventive action. Objective Our aim was to determine the effectiveness of a tailored, computer-based, interactive personal action planning session to initiate PA among a group of sedentary cardiac patients following exercise treadmill testing (ETT). Methods This study was part of a larger 2x2 randomized controlled trial to determine the impact of environmental and social-cognitive intervention approaches on the initiation and maintenance of weekly PA for patients post ETT. Participants who were referred to an ETT center but had a negative-test (ie, stress tests results indicated no apparent cardiac issues) were randomized to one of four treatment arms: (1) increased environmental accessibility to PA resources via the provision of a free voucher to a fitness facility in close proximity to their home or workplace (ENV), (2) a tailored social cognitive intervention (SC) using a “5 As”-based (ask, advise, assess, assist, and arrange) personal action planning tool, (3) combined intervention of both ENV and SC approaches (COMBO), or (4) a matched contact nutrition control (CON). Each intervention was delivered using a computer-based interactive session. A general linear model for repeated measures was conducted with change in PA behavior from baseline to 1-month post interactive computer session as the primary outcome. Results Sedentary participants (n=452; 34.7% participation rate) without

  3. The efficacy of a behavioral activation intervention among depressed US Latinos with limited English language proficiency: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    . The study is also among the first to examine the effect of the proposed mechanisms of change of behavioral activation treatment for depression (that is, activity level and environmental reward) on depression over time. To our knowledge, this is the first randomized controlled trial to compare an empirical-supported treatment to a control supportive counseling condition in a sample of depressed, Spanish-speaking Latinos in the United States. Trial registration Clinical Trials Register: NCT01958840; registered 8 October 2013. PMID:24938081

  4. Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

    PubMed Central

    Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

    2016-01-01

    Introduction Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Methods and analysis Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3–4 physiotherapists) and a focus group (n=6–8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). Ethics and dissemination This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). Trial

  5. Two-Year Longitudinal Analysis of a Cluster Randomized Trial of Physical Activity Promotion by General Practitioners

    PubMed Central

    Grandes, Gonzalo; Sanchez, Alvaro; Montoya, Imanol; Ortega Sanchez-Pinilla, Ricardo; Torcal, Jesús

    2011-01-01

    patients during the initial six-months of an intervention but this effect wears off at 12 and 24 months. Only in the subgroup of patients receiving repeat prescriptions of physical activity is the effect maintained in long-term. Trial Registration clinicaltrials.gov NCT00131079 PMID:21479243

  6. Pesticide Registration Information System

    EPA Pesticide Factsheets

    PRISM provides an integrated, web portal for all pesticide related data, communications, registrations and transactions for OPP and its stakeholders, partners and customers. PRISM supports Strategic Goal 4 by automating pesticide registration processes.

  7. HIV Vaccine Trials Network: activities and achievements of the first decade and beyond

    PubMed Central

    Kublin, James G; Morgan, Cecilia A; Day, Tracey A; Gilbert, Peter B; Self, Steve G; McElrath, M Juliana; Corey, Lawrence

    2012-01-01

    The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators facilitating the development of HIV/AIDS preventive vaccines. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity, to testing vaccine efficacy. Over the past decade, the HVTN has aimed to improve the process of designing, implementing and analyzing vaccine trials. Several major achievements include streamlining protocol development while maintaining input from diverse stakeholders, establishing a laboratory program with standardized assays and systems allowing for reliable immunogenicity assessments across trials, setting statistical standards for the field and actively engaging with site communities. These achievements have allowed the HVTN to conduct over 50 clinical trials and make numerous scientific contributions to the field. PMID:23243491

  8. Pesticide Registration

    EPA Pesticide Factsheets

    This site provides resources for an individual or company wanting to register a pesticide active ingredient or pesticide product in the United States. Features: a manual (blue book), other guidance, and coordinated lists of requirements by pesticide type.

  9. 76 FR 12888 - Registration of Intermediaries

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... options and retail foreign exchange intermediaries, their associated persons (APs), and floor traders and... decided to issue regulations that impose a registration requirement on floor brokers and floor traders... traders. SDs and MSPs were not added if the provision was only addressing registration activities of...

  10. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial

    PubMed Central

    2010-01-01

    individual levels. Teacher qualitative interviews monitor the intervention implementation process. Discussion Participatory approaches that actively involve parents have the potential to promote PA in ways that might be better tailored to local needs and more sustainable. Our mixed methods approach to assess the intervention efficacy and implementation employing both quantitative and qualitative measures within a cluster-randomized controlled trial may serve as a framework for evaluating public health interventions in preschool settings. Trial Registration clinicaltrials.gov No: NCT00987532 PMID:20113522

  11. The Effect of a Physical Activity Program on the Total Number of Primary Care Visits in Inactive Patients: A 15-Month Randomized Controlled Trial

    PubMed Central

    Giné-Garriga, Maria; Martin-Borràs, Carme; Puig-Ribera, Anna; Martín-Cantera, Carlos; Solà, Mercè; Cuesta-Vargas, Antonio

    2013-01-01

    Background Effective promotion of exercise could result in substantial savings in healthcare cost expenses in terms of direct medical costs, such as the number of medical appointments. However, this is hampered by our limited knowledge of how to achieve sustained increases in physical activity. Objectives To assess the effectiveness of a Primary Health Care (PHC) based physical activity program in reducing the total number of visits to the healthcare center among inactive patients, over a 15-month period. Research Design Randomized controlled trial. Subjects Three hundred and sixty-two (n = 362) inactive patients suffering from at least one chronic condition were included. One hundred and eighty-three patients (n = 183; mean (SD); 68.3 (8.8) years; 118 women) were randomly allocated to the physical activity program (IG). One hundred and seventy-nine patients (n = 179; 67.2 (9.1) years; 106 women) were allocated to the control group (CG). The IG went through a three-month standardized physical activity program led by physical activity specialists and linked to community resources. Measures The total number of medical appointments to the PHC, during twelve months before and after the program, was registered. Self-reported health status (SF-12 version 2) was assessed at baseline (month 0), at the end of the intervention (month 3), and at 12 months follow-up after the end of the intervention (month 15). Results The IG had a significantly reduced number of visits during the 12 months after the intervention: 14.8 (8.5). The CG remained about the same: 18.2 (11.1) (P = .002). Conclusions Our findings indicate that a 3-month physical activity program linked to community resources is a short-duration, effective and sustainable intervention in inactive patients to decrease rates of PHC visits. Trial Registration ClinicalTrials.gov NCT00714831 PMID:23805219

  12. Promoting Physical Activity in Middle School Girls: Trial of Activity for Adolescent Girls

    PubMed Central

    Webber, Larry S.; Catellier, Diane J.; Lytle, Leslie A.; Murray, David M.; Pratt, Charlotte A.; Young, Deborah R.; Elder, John P.; Lohman, Timothy G.; Stevens, June; Jobe, Jared B.; Pate, Russell R.

    2008-01-01

    Background Physical activity is important for weight control and good health; however, activity levels decline in the adolescent years, particularly in girls. Design Group randomized controlled trial Setting/participants Middle school girls with English-speaking skills and no conditions to prevent participation in physical activity in 36 schools in six geographically diverse areas of the United States. Random, cross-sectional samples were drawn within schools: 6th graders in 2003 (n=1721) and 8th graders in 2005 (n=3504) and 2006 (n=3502). Intervention A 2-year study-directed intervention (fall 2003 to spring 2005) targeted schools, community agencies, and girls to increase opportunities, support, and incentives for increased physical activity. Components included programs linking schools and community agencies, physical education, health education, and social marketing. A third-year intervention used school and community personnel to direct intervention activities. Main outcome measures The primary outcome, daily MET-weighted minutes of moderate-to-vigorous physical activity (MET-weighted MVPA), was assessed using accelerometry. Percent body fat was assessed using anthropometry. Results After the staff-directed intervention (pre-stated primary outcome), there were no differences (mean= −0.4, 95% CI= CI= −8.2 to 7.4) in adjusted MET-weighted MVPA between 8th-grade girls in schools assigned to intervention or control. Following the Program Champion–directed intervention, girls in intervention schools were more physically active than girls in control schools (mean difference 10.9 MET-weighted minutes of MVPA, 95% CI=0.52–21.2). This difference is about 1.6 minutes of daily MVPA or 80 kcal per week. There were no differences in fitness or percent body fat at either 8th-grade timepoint. Conclusion A school-based, community-linked intervention modestly improved physical activity in girls. PMID:18312804

  13. Design and baseline characteristics of the ParkFit study, a randomized controlled trial evaluating the effectiveness of a multifaceted behavioral program to increase physical activity in Parkinson patients

    PubMed Central

    2010-01-01

    Background Many patients with Parkinson's disease (PD) lead a sedentary lifestyle. Promotion of physical activities may beneficially affect the clinical presentation of PD, and perhaps even modify the course of PD. However, because of physical and cognitive impairments, patients with PD require specific support to increase their level of physical activity. Methods We developed the ParkFit Program: a PD-specific and multifaceted behavioral program to promote physical activity. The emphasis is on creating a behavioral change, using a combination of accepted behavioral motivation techniques. In addition, we designed a multicentre randomized clinical trial to investigate whether this ParkFit Program increases physical activity levels over two years in sedentary PD patients. We intended to include 700 sedentary patients. Primary endpoint is the time spent on physical activities per week, which will be measured every six months using an interview-based 7-day recall. Results In total 3453 PD patients were invited to participate. Ultimately, 586 patients - with a mean (SD) age of 64.1 (7.6) years and disease duration of 5.3 (4.5) years - entered the study. Study participants were younger, had a shorter disease duration and were less sedentary compared with eligible PD patients not willing to participate. Discussion The ParkFit trial is expected to yield important new evidence about behavioral interventions to promote physical activity in sedentary patients with PD. The results of the trial are expected in 2012. Trial registration http://clinicaltrials.gov (nr NCT00748488). PMID:20723221

  14. Randomised controlled trials of physical activity promotion in free living populations: a review.

    PubMed Central

    Hillsdon, M; Thorogood, M; Anstiss, T; Morris, J

    1995-01-01

    OBJECTIVES--To review evidence on the effectiveness of trials of physical activity promotion in healthy, free living adults. To identify the more effective intervention programmes. METHODS--Computerised databases and references were searched. Experts were contacted and asked for information about existing work. INCLUSION CRITERIA--Randomised controlled trials of healthy, free living adult subjects, where exercise behaviour was the dependent variable were included. CONCLUSIONS--Ten trials were identified. The small number of trials limits the strength of any conclusions and highlights the need for more research. No UK based studies were found. Previously sedentary adults can increase activity levels and sustain them. Promotion of these changes requires personal instruction, continued support, and exercise of moderate intensity which does not depend on attendance at a facility. The exercise should be easily included into an existing lifestyle and should be enjoyable. Walking is the exercise most likely to fulfil these criteria. PMID:7499985

  15. Clinical, biochemical and imaging methods of assessing osteoarthritis and clinical trials with agents claiming 'chondromodulating' activity.

    PubMed

    Theiler, R; Ghosh, P; Brooks, P

    1994-03-01

    This paper reviews, in a first part, methods used for the clinical assessment of osteoarthritis (OA) with special reference, in a second part, to trials of drugs claimed to be chondromodulating agents. The agents examined include glycosaminoglycan-peptide complex (GP-C, Rumalon) and glycosaminoglycan-polysulfate (GAGPS, Arteparon), which both showed some beneficial clinical response. However, their effect on cartilage still remains controversial. The development of a functional hip and knee OA index in clinical assessment and the role of imaging methods and biochemical markers are discussed. In future clinical trials only validated OA indices such as the Lequesne or WOMAC index and the newly established ILAR guidelines for classifying and testing drugs in OA will be accepted for registration purposes. Imaging methods including magnetic resonance imaging (MRI) offer the capacity to provide more precise information concerning cartilage destruction in OA joints. In addition, the biochemical assessment of proteoglycan fragments, bone sialoprotein (BSP), cartilage oligometric matrix protein (COMP) and the balance between stromelysin and its inhibitor (TIMP) in synovial fluid would appear to offer potential applications for the determination of joint tissue damage in the early and later stages of OA. However, these biochemical markers have yet to be validated. It is clear that in the 1990s, for a drug to be designated as disease modifying in OA, it will require a more rigorous evaluation than was hitherto required.

  16. Community-based physical activity and nutrition programme for adults with metabolic syndrome in Vietnam: study protocol for a cluster-randomised controlled trial

    PubMed Central

    Tran, Van Dinh; Lee, Andy H; Jancey, Jonine; James, Anthony P; Howat, Peter; Thi Phuong Mai, Le

    2016-01-01

    Introduction Metabolic syndrome (MetS) is a cluster of risk factors for cardiovascular diseases and type II diabetes. In Vietnam, more than one-quarter of its population aged 50–65 have MetS. This cluster-randomised controlled trial aims to evaluate the effectiveness of interventions to increase levels of physical activity and improve dietary behaviours among Vietnamese adults aged 50–65 years with MetS. Method and analysis This 6-month community-based intervention includes a range of strategies to improve physical activity and nutrition for adults with MetS in Hanam, a province located in northern Vietnam. 600 participants will be recruited from 6 communes with 100 participants per commune. The 6 selected communes will be randomly allocated to either an intervention group (m=3; n=300) or a control group (m=3; n=300). The intervention comprises booklets, education sessions, resistance bands and attending local walking groups that provide information and encourage participants to improve their physical activity and healthy eating behaviours during the 6-month period. The control group participants will receive standard and 1-time advice. Social cognitive theory is the theoretical concept underpinning this study. Measurements will be taken at baseline and postintervention to evaluate programme effectiveness. Ethics and dissemination The research protocol was approved by the Curtin University Human Research Ethics Committee (approval number: HR139/2014). The results of the study will be disseminated through publications, reports and conference presentations. Trial registration number ACTRN12614000811606. PMID:27256094

  17. Activities of Tannins--From In Vitro Studies to Clinical Trials.

    PubMed

    Sieniawska, Elwira

    2015-11-01

    Tannins are considered as valuable plant secondary metabolites providing many benefits for human health. In this review information was gathered about bioactivity in vitro and in vivo, as well as about conducted clinical trials. The literature research was based on ScienceDirect, Scopus, and Cochrane databases and presents a wide range of tested activities of tannins. The described clinical trials verify laboratory tests and show the effective health benefits taken from supplementation with tannins.

  18. The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls) randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

    PubMed Central

    2010-01-01

    Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools. Methods/Design The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA) sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored. Discussion NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an important contribution to the

  19. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

    PubMed Central

    Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

    2011-01-01

    Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

  20. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder.

    PubMed

    Schneider, Kristin L; Pagoto, Sherry L; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S; Ma, Yunsheng

    2011-06-01

    BACKGROUND: The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. METHODS/DESIGN: Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. DISCUSSION: A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. TRIAL REGISTRATION: NCT01024790.

  1. Theory-Based Behavioral Intervention Increases Self-Reported Physical Activity in South African Men: A Cluster-Randomized Controlled Trial

    PubMed Central

    Jemmott, John B.; Jemmott, Loretta S.; Ngwane, Zolani; Zhang, Jingwen; Heeren, G. Anita; Icard, Larry D.; O’Leary, Ann; Mtose, Xoliswa; Teitelman, Anne; Carty, Craig

    2014-01-01

    Objective To determine whether a health-promotion intervention increases South African men’s adherence to physical-activity guidelines. Method We utilized a cluster-randomized controlled trial design. Eligible clusters, residential neighborhoods near East London, South Africa, were matched in pairs. Within randomly selected pairs, neighborhoods were randomized to theory-based, culturally congruent health-promotion intervention encouraging physical activity or attention-matched HIV/STI risk-reduction control intervention. Men residing in the neighborhoods and reporting coitus in the previous 3 months were eligible. Primary outcome was self-reported individual-level adherence to physical-activity guidelines averaged over 6-month and 12-month post-intervention assessments. Data were collected in 2007–2010. Data collectors, but not facilitators or participants, were blind to group assignment. Results Primary outcome intention-to-treat analysis included 22 of 22 clusters and 537 of 572 men in the health-promotion intervention and 22 of 22 clusters and 569 of 609 men in the attention-control intervention. Model-estimated probability of meeting physical-activity guidelines was 51.0% in the health-promotion intervention and 44.7% in attention-matched control (OR = 1.34; 95% CI, 1.09–1.63), adjusting for baseline prevalence and clustering from 44 neighborhoods. Conclusion A theory-based culturally congruent intervention increased South African men’s self-reported physical activity, a key contributor to deaths from non-communicable diseases in South Africa. Trial registration ClinicalTrials.gov Identifier: NCT01490359. PMID:24736094

  2. An Internet-Based Virtual Coach to Promote Physical Activity Adherence in Overweight Adults: Randomized Controlled Trial

    PubMed Central

    Bickmore, Timothy; Cange, Abby; Kulshreshtha, Ambar; Kvedar, Joseph

    2012-01-01

    . The long-term benefits and additional applications of this technology warrant further study. Trial Registration ClinicalTrials.gov NCT00792207; http://clinicaltrials.gov/ct2/show/NCT00792207 (Archived by WebCite at http://www.webcitation.org/63sm9mXUD) PMID:22281837

  3. 28 CFR 10.6 - Necessity for further registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Necessity for further registration. 10.6 Section 10.6 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN ORGANIZATIONS CARRYING ON ACTIVITIES WITHIN THE UNITED STATES Registration Statement § 10.6 Necessity for...

  4. Interventions for physical activity promotion applied to the primary healthcare settings for people living in regions of low socioeconomic level: study protocol for a non-randomized controlled trial

    PubMed Central

    2014-01-01

    Background Regular physical activity practice has been widely recommended for promoting health, but the physical activity levels remain low in the population. Therefore, the study of interventions to promote physical activity is essential. Objective: To present the methodology of two physical activity interventions from the “Ambiente Ativo” (“Active Environment”) project. Methods 12-month non-randomized controlled intervention trial. 157 healthy and physically inactive individuals were selected: health education (n = 54) supervised exercise (n = 54) and control (n = 49). Intervention based on health education: a multidisciplinary team of health professionals organized the intervention in group discussions, phone calls, SMS and educational material. Intervention based on supervised exercise program: consisted of offering an exercise program in groups supervised by physical education professionals involving strength, endurance and flexibility exercises. The physical activity level was assessed by the International Physical Activity Questionnaire (long version), physical activities recalls, pedometers and accelerometers over a seven-day period. Result This study described two different proposals for promoting physical activity that were applied to adults attended through the public healthcare settings. The participants were living in a region of low socioeconomic level, while respecting the characteristics and organization of the system and its professionals, and also adapting the interventions to the realities of the individuals attended. Conclusion Both interventions are applicable in regions of low socioeconomic level, while respecting the social and economic characteristics of each region. Trial registration ClinicalTrials.gov NCT01852981 PMID:24624930

  5. Changes in Physical Activity Following a Genetic-Based Internet-Delivered Personalized Intervention: Randomized Controlled Trial (Food4Me)

    PubMed Central

    Livingstone, Katherine M; Fallaize, Rosalind; Kolossa, Silvia; Hallmann, Jacqueline; San-Cristobal, Rodrigo; Navas-Carretero, Santiago; O'Donovan, Clare B; Woolhead, Clara; Forster, Hannah; Moschonis, George; Lambrinou, Christina-Paulina; Surwillo, Agnieszka; Godlewska, Magdalena; Hoonhout, Jettie; Goris, Annelies; Macready, Anna L; Walsh, Marianne C; Gibney, Eileen R; Brennan, Lorraine; Manios, Yannis; Traczyk, Iwona; Drevon, Christian A; Lovegrove, Julie A; Martinez, J Alfredo; Daniel, Hannelore; Gibney, Michael J; Mathers, John C; Saris, Wim HM

    2016-01-01

    Background There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown. Objective The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention. Methods The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no). Results At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts. Conclusions No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies

  6. The Walking School Bus and children's physical activity: A pilot cluster randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    To evaluate the impact of a "walking school bus" program on children's rates of active commuting to school and physical activity. We conducted a pilot cluster randomized controlled trial among 4th-graders from 8 schools in Houston, Texas (N = 149). Random allocation to treatment or control condition...

  7. Increasing activity in older adults: A review of the Look AHEAD trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The importance of physical activity for healthy aging has been clearly shown. Evidence from the Look AHEAD trial, a lifestyle intervention for overweight individuals who have type 2 diabetes, provides further evidence for the importance of physical activity. Overall, this intervention provides a pot...

  8. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion—Learning, Cognition and Motion – A Cluster Randomized Controlled Trial

    PubMed Central

    Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H.; Andersen, Lars Bo; Bugge, Anna

    2016-01-01

    Background Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12–14 years old adolescents. Methods A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. Results No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p’s>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4–38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39–0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0–9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p’s>0.05). Conclusions No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing

  9. Comparison between sensory and motor transcutaneous electrical nervous stimulation on electromyographic and kinesiographic activity of patients with temporomandibular disorder: a controlled clinical trial

    PubMed Central

    2013-01-01

    Background The purpose of the present controlled clinical trial was to assess the effect of a single 60 min application of transcutaneous electrical nervous stimulation (TENS) at sensory stimulation threshold (STS), compared to the application of motor stimulation threshold (MTS) as well as to untreatment, on the surface electromyographic (sEMG) and kinesiographic activity of patients with tempormanbibular disorder (TMD). Methods Sixty female subjects, selected according to the inclusion/exclusion criteria, suffering from unilateral TMD in remission were assigned to MTS, STS or untreatment. Pre- and post-treatment differences in the sEMG activity of temporalis anterior (TA), masseter (MM), digastric (DA) and sternocleidomastoid muscles (SCM), as well in the interocclusal distance (ID), within group were tested using the Wilcoxon test, while differences among groups were assessed by Kruskal-Wallis test; the level of significance was set at p ≤ 0.05. Results Significant pre- and post-treatment differences were observed in MTS and STS groups, for TA and MM of both sides; no significant difference was detected between MTS and STS groups. Kinesiographic results showed that the vertical component of ID was significantly increased after TENS in MTS and STS groups. Conclusions STS TENS could be effective, as well as MTS, in reduce the sEMG activity of masticatory muscles and to improve the ID of TMD patients in remission. Future studies are needed to confirm the results of the present study. Clinical relevance. The present study demonstrates that the application of TENS is effective in reduce the sEMG activity, as well as in increasing the ID of patients with TMD; our study did not support superior effectiveness of MTS or STS. Trial registration ClinicalTrials.gov: NCT01832207 PMID:23672400

  10. A home-based exercise intervention to increase physical activity among people living with HIV: study design of a randomized clinical trial

    PubMed Central

    2013-01-01

    Background While combination antiretroviral therapy has extended the life expectancy of those infected with human immunodeficiency virus (HIV), there is a high prevalence of comorbidities that increase the risk of cardiovascular morbidity and mortality among people living with HIV/AIDS (PLWHA). The side effects associated with antiretroviral therapy (ART) lead to multiple metabolic disorders, making the management of these metabolic issues and risk of cardiovascular disease (CVD) in those treated with ART a critical issue. Clinical research trials, primarily clinical exercise, rarely include this population due to unique challenges in research methods with underserved minority populations living with a life threatening illness like HIV/AIDS. This paper describes the rationale and design of a randomized clinical trial evaluating the feasibility of a home-based exercise program designed to increase physical activity (PA) and reduce the risk of CVD in PLWHA. Methods/design PLWHA being treated with ART will be randomly assigned to one of two groups: a home-based PA intervention or standard care. All participants will receive an educational weight loss workbook and pedometer for self-monitoring of PA. Only those in the intervention group will receive additional elastic Thera-bands® for strength training and behavioral telephone based coaching. Discussion This study will evaluate the feasibility of a home-based program designed to increase PA among PLWHA. Further, it will evaluate the effectiveness of such a program to decrease modifiable risk factors for CVD as a secondary outcome. This study was funded by the NIH/NINR R21 Grant 1R21NRO11281. Trial registration Clinical Trial Identifier NCT01377064 PMID:23706094

  11. Active Inference, Epistemic Value, and Vicarious Trial and Error

    ERIC Educational Resources Information Center

    Pezzulo, Giovanni; Cartoni, Emilio; Rigoli, Francesco; io-Lopez, Léo; Friston, Karl

    2016-01-01

    Balancing habitual and deliberate forms of choice entails a comparison of their respective merits--the former being faster but inflexible, and the latter slower but more versatile. Here, we show that arbitration between these two forms of control can be derived from first principles within an Active Inference scheme. We illustrate our arguments…

  12. Behavioral Activation for Moderately Depressed University Students: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Gawrysiak, Michael; Nicholas, Christopher; Hopko, Derek R.

    2009-01-01

    Although depression is prevalent among university students, limited and dated research has examined the efficacy of behavioral interventions in treating this population (C. Lee, 2005). On the basis of a modified version of the Behavioral Activation Treatment for Depression (BATD; D. R. Hopko & C. W. Lejuez, 2007; C. W. Lejuez, D. R. Hopko, & S. D.…

  13. 76 FR 38160 - Pesticide Products; Registration Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... AGENCY Pesticide Products; Registration Applications AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has received applications to register pesticide products containing an active ingredient not included in any previously registered pesticide products. Pursuant to...

  14. 75 FR 24694 - Pesticide Products; Registration Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... AGENCY Pesticide Products; Registration Applications AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has received applications to register pesticide products containing an active ingredient not included in any previously registered pesticide product. Pursuant to the...

  15. 1,2-Octanediol, a Novel Surfactant, for Treating Head Louse Infestation: Identification of Activity, Formulation, and Randomised, Controlled Trials

    PubMed Central

    Burgess, Ian F.; Lee, Peter N.; Kay, Katrina; Jones, Ruth; Brunton, Elizabeth R.

    2012-01-01

    Background Interest in developing physically active pediculicides has identified new active substances. The objective was to evaluate a new treatment for clinical efficacy. Methods and Findings We describe the selection of 1,2-octanediol as a potential pediculicide. Clinical studies were community based. The main outcome measure was no live lice, after two treatments, with follow up visits over 14 days. Study 1 was a proof of concept with 18/20 (90%) participants cured. Study 2 was a multicentre, parallel, randomised, observer-blind study (520 participants) that compared 0.5% malathion liquid with 1,2-octanediol lotion (20% alcohol) applied 2–2.5 hours or 8 hours/overnight. 1,2-octanediol lotion was significantly (p<0.0005) more effective with success for 124/175 (70.9%) RR = 1.50 (97.5% CI, 1.22 to 1.85) for 2–2.5 hours, and 153/174 (87.9%) RR = 1.86 (97.5% CI, 1.54 to 2.26) for 8 hours/overnight compared with 81/171 (47.4%) for malathion. Study 3, a two centre, parallel, randomised, observer-blind study (121 participants), compared 1,2-octanediol lotion, 2–2.5 hours with 1,2-octanediol alcohol free mousse applied for 2–2.5 hours or 8 hours/overnight. The mousse applied for 8 hours/overnight cured 31/40 (77.5%), compared with 24/40 (60.0%) for lotion (RR = 1.29, 95% CI, 0.95 to 1.75; NNT = 5.7) but mousse applied for 2–2.5 hours 17/41 (41.5%) was less effective than lotion (RR = 0.69, 95% CI, 0.44 to 1.08). Adverse events were more common using 1,2-octanediol lotion at both 2–2.5 hours (12.0%, p = 0.001) and 8 hours/overnight (14.9%, p<0.0005), compared with 0.5% malathion (2.3%). Similar reactions were more frequent (p<0.045) using lotion compared with mousse. Conclusions 1,2-octanediol was found to eliminate head louse infestation. It is believed to disrupt the insect's cuticular lipid, resulting in dehydration. The alcohol free mousse is more acceptable exhibiting significantly fewer adverse reactions. Trial registrations

  16. Image Registration Workshop Proceedings

    NASA Technical Reports Server (NTRS)

    LeMoigne, Jacqueline (Editor)

    1997-01-01

    Automatic image registration has often been considered as a preliminary step for higher-level processing, such as object recognition or data fusion. But with the unprecedented amounts of data which are being and will continue to be generated by newly developed sensors, the very topic of automatic image registration has become and important research topic. This workshop presents a collection of very high quality work which has been grouped in four main areas: (1) theoretical aspects of image registration; (2) applications to satellite imagery; (3) applications to medical imagery; and (4) image registration for computer vision research.

  17. LEARN 2 MOVE 7-12 years: a randomized controlled trial on the effects of a physical activity stimulation program in children with cerebral palsy

    PubMed Central

    2010-01-01

    intervention group, with primary outcomes and secondary outcomes as the dependent variables. Discussion This is the first study that investigates the effect of a combined lifestyle intervention and fitness training on physical activity. Temporary effects of the fitness training are expected to be maintained by changes to an active lifestyle in daily life and in the home situation. Trial registration This study is registered in the Dutch Trial Register as NTR2099. PMID:21044314

  18. Effect of a Nutrition Supplement and Physical Activity Program on Pneumonia and Walking Capacity in Chilean Older People: A Factorial Cluster Randomized Trial

    PubMed Central

    Dangour, Alan D.; Albala, Cecilia; Allen, Elizabeth; Grundy, Emily; Walker, Damian G.; Aedo, Cristian; Sanchez, Hugo; Fletcher, Olivia; Elbourne, Diana; Uauy, Ricardo

    2011-01-01

    people is not effective in reducing the incidence of pneumonia. This trial suggests that the provision of locally accessible physical activity classes in a transition economy population can be a cost-effective means of enhancing physical function in later life. Trial registration Current Controlled Trials ISRCTN 48153354 Please see later in the article for the Editors' Summary PMID:21526229

  19. Physical activity and academic achievement across the curriculum (A + PAAC): rationale and design of a 3-year, cluster-randomized trial

    PubMed Central

    2013-01-01

    Background Improving academic achievement and reducing the rates of obesity in elementary school students are both of considerable interest. Increased physical activity during academic instruction time during school offers a potential intervention to address both issues. A program titled “Physical Activity Across the Curriculum” (PAAC) was developed in which classroom teachers in 22 elementary schools were trained to deliver academic instruction using physical activity with a primary aim of preventing increased BMI. A secondary analysis of data assessed the impact of PAAC on academic achievement using the Weschler Individual Achievement Test-II and significant improvements were shown for reading, math and spelling in students who participated in PAAC. Based on the results from PAAC, an adequately powered trial will be conducted to assess differences in academic achievement between intervention and control schools called, “Academic Achievement and Physical Activity Across the Curriculum (A + PAAC).” Methods/design Seventeen elementary schools were cluster randomized to A + PAAC or control for a 3-year trial. Classroom teachers were trained to deliver academic instruction through moderate-to-vigorous physical activity with a target of 100+ minutes of A + PAAC activities per week. The primary outcome measure is academic achievement measured by the Weschler Individual Achievement Test-III, which was administered at baseline (Fall 2011) and will be repeated in the spring of each year by assessors blinded to condition. Potential mediators of any association between A + PAAC and academic achievement will be examined on the same schedule and include changes in cognitive function, cardiovascular fitness, daily physical activity, BMI, and attention-to-task. An extensive process analysis will be conducted to document the fidelity of the intervention. School and student recruitment/randomization, teacher training, and baseline testing for A

  20. Ritodrine in Oral Maintenance of Tocolysis after Active Preterm Labor: Randomized Controlled Trial

    PubMed Central

    Matijević, Ratko; Grgić, Ozren; Vasilj, Oliver

    2006-01-01

    Aim To assess the efficacy of oral ritodrine in the form of sustained-release capsules for maintenance of uterine quiescence after successful treatment of threatened preterm labor. Methods We randomized 120 women with singleton pregnancy who were successfully treated for threatened preterm labor before 34 completed weeks to receive either maintenance tocolysis with two 40 mg ritodrine sustained release capsules three times a day (study group, n = 62) or no treatment (control group, n = 58) for three days. The primary outcome measure was the recurrent episode of threatened preterm labor within 72 hours, which was defined as regular palpable uterine contractions and change in cervical effacement or cervical dilatation on clinical examination. Secondary outcome measures included the incidence of preterm birth, neonatal adverse outcomes, and maternal side effects. Results There was no difference in the frequency of recurrent episodes of threatened preterm labor requiring another course of intravenous treatment between the study (8/62) and control (6/58) group of women (P = 0.879). No differences were found between the study and control groups in any of the predefined secondary outcome measures, ie, delivery before 37 weeks (13/62 vs 7/58, respectively; P = 0.288), delivery before 34 weeks (3/62 vs 1/58, respectively; P = 0.682) and birth weight (3037 ± 573 g vs 3223 ± 423 g, respectively, P = 0.862). There were more reported maternal side effects in the study group than in control group (47/62 vs 23/58, respectively; P<0.001). Conclusions Additional maintenance ritodrine therapy was unnecessary in women with singleton pregnancy who had an episode of threatened preterm labor successfully treated with intravenous tocolytic therapy. Clinical Trial Registration ClinicalTrials.gov Identifier: NCT00290173 PMID:16489694

  1. Initial Open Trial of a Computerized Behavioral Activation Treatment for Depression

    ERIC Educational Resources Information Center

    Spates, C. Richard; Kalata, Alyssa H.; Ozeki, Satoshi; Stanton, Cory E.; Peters, Sofia

    2013-01-01

    This article presents preliminary findings from use of a novel computer program that implements an evidence-based psychological intervention to treat depression based on behavioral activation (BA) therapy. The program is titled “Building a Meaningful Life Through Behavioral Activation”. The findings derive from an open trial with moderate to…

  2. Feedback about More Accurate versus Less Accurate Trials: Differential Effects on Self-Confidence and Activation

    ERIC Educational Resources Information Center

    Badami, Rokhsareh; VaezMousavi, Mohammad; Wulf, Gabriele; Namazizadeh, Mahdi

    2012-01-01

    One purpose of the present study was to examine whether self-confidence or anxiety would be differentially affected by feedback from more accurate rather than less accurate trials. The second purpose was to determine whether arousal variations (activation) would predict performance. On Day 1, participants performed a golf putting task under one of…

  3. The Impact of Curtin University's Activity, Food and Attitudes Program on Physical Activity, Sedentary Time and Fruit, Vegetable and Junk Food Consumption among Overweight and Obese Adolescents: A Waitlist Controlled Trial

    PubMed Central

    Straker, Leon M.; Howie, Erin K.; Smith, Kyla L.; Fenner, Ashley A.; Kerr, Deborah A.; Olds, Tim S.; Abbott, Rebecca A.; Smith, Anne J.

    2014-01-01

    Background To determine the effects of participation in Curtin University's Activity, Food and Attitudes Program (CAFAP), a community-based, family-centered behavioural intervention, on the physical activity, sedentary time, and healthy eating behaviours of overweight and obese adolescents. Methods In this waitlist controlled clinical trial in Western Australia, adolescents (n = 69, 71% female, mean age 14.1 (SD 1.6) years) and parents completed an 8-week intervention followed by 12 months of telephone and text message support. Assessments were completed at baseline, before beginning the intervention, immediately following the intervention, and at 3-, 6-, and 12- months follow-up. The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit, vegetables and junk food assessed by 3-day food records. Results During the intensive 8-week intervention sedentary time decreased by −5.1 min/day/month (95% CI: −11.0, 0.8) which was significantly greater than the rate of change during the waitlist period (p = .014). Moderate physical activity increased by 1.8 min/day/month (95% CI: −0.04, 3.6) during the intervention period, which was significantly greater than the rate of change during the waitlist period (p = .041). Fruit consumption increased during the intervention period (monthly incidence rate ratio (IRR) 1.3, 95% CI: 1.10, 1.56) and junk food consumption decreased (monthly IRR 0.8, 95% CI: 0.74, 0.94) and these changes were different to those seen during the waitlist period (p = .004 and p = .020 respectively). Conclusions Participating in CAFAP appeared to have a positive influence on the physical activity, sedentary and healthy eating behaviours of overweight and obese adolescents and many of these changes were maintained for one year following the intensive intervention. Trial Registration Australia and New Zealand Clinical Trials Registry ACTRN12611001187932 PMID:25375109

  4. Effects of exercise on markers of oxidative stress: an Ancillary analysis of the Alberta Physical Activity and Breast Cancer Prevention Trial

    PubMed Central

    Friedenreich, Christine M; Pialoux, Vincent; Wang, Qinggang; Shaw, Eileen; Brenner, Darren R; Waltz, Xavier; Conroy, Shannon M; Johnson, Rhys; Woolcott, Christy G; Poulin, Marc J; Courneya, Kerry S

    2016-01-01

    Background Oxidative stress may contribute to cancer aetiology through several mechanisms involving damage to DNA, proteins and lipids leading to genetic mutations and genomic instability. The objective of this study was to determine the effects of aerobic exercise on markers of oxidative damage and antioxidant enzymes in postmenopausal women. Methods The Alberta Physical Activity and Breast Cancer Prevention Trial (ALPHA) was a two-centre, two-armed randomised trial of 320 inactive, healthy, postmenopausal women aged 50–74 years. Participants were randomly assigned to a year-long exercise intervention (225 min/week) or a control group while being asked to maintain a normal diet. Fasting blood samples were obtained and plasma concentrations of two oxidative damage markers (8-hydroxy-2′-deoxyguanosine (8-OHdG) and 8-isoprostaglandin F2α (8-Iso-PGF2α)) and two antioxidant enzymes (superoxide dismutase and catalase) were measured at baseline, 6 months and 12 months. Intention-to-treat (ITT) and per-protocol analyses were performed using linear mixed models adjusted for baseline biomarker concentrations. A further exercise adherence analysis, based on mean minutes of exercise per week, was also performed. Results In the ITT and per-protocol analyses, the exercise intervention did not have any statistically significant effect on either oxidative damage biomarkers or antioxidant enzyme activity. Conclusions A year-long aerobic exercise intervention did not have a significant impact on oxidative stress in healthy, postmenopausal women. Trial registration number NCT00522262. PMID:27900199

  5. Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light - a randomized clinical trial

    PubMed Central

    2010-01-01

    Background Depression frequently occurs in the elderly and in patients suffering from dementia. Its cause is largely unknown, but several studies point to a possible contribution of circadian rhythm disturbances. Post-mortem studies on aging, dementia and depression show impaired functioning of the suprachiasmatic nucleus (SCN) which is thought to be involved in the increased prevalence of day-night rhythm perturbations in these conditions. Bright light enhances neuronal activity in the SCN. Bright light therapy has beneficial effects on rhythms and mood in institutionalized moderate to advanced demented elderly. In spite of the fact that this is a potentially safe and inexpensive treatment option, no previous clinical trial evaluated the use of long-term daily light therapy to prevent worsening of sleep-wake rhythms and depressive symptoms in early to moderately demented home-dwelling elderly. Methods/Design This study investigates whether long-term daily bright light prevents worsening of sleep-wake rhythms and depressive symptoms in elderly people with memory complaints. Patients with early Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI) and Subjective Memory Complaints (SMC), between the ages of 50 and 75, are included in a randomized double-blind placebo-controlled trial. For the duration of two years, patients are exposed to ~10,000 lux in the active condition or ~300 lux in the placebo condition, daily, for two half-hour sessions at fixed times in the morning and evening. Neuropsychological, behavioral, physiological and endocrine measures are assessed at baseline and follow-up every five to six months. Discussion If bright light therapy attenuates the worsening of sleep-wake rhythms and depressive symptoms, it will provide a measure that is easy to implement in the homes of elderly people with memory complaints, to complement treatments with cholinesterase inhibitors, sleep medication or anti-depressants or as a stand-alone treatment. Trial

  6. Family-Based Cluster Randomized Controlled Trial Enhancing Physical Activity and Motor Competence in 4–7-Year-Old Children

    PubMed Central

    Laukkanen, Arto; Pesola, Arto Juhani; Heikkinen, Risto; Sääkslahti, Arja Kaarina; Finni, Taija

    2015-01-01

    Little is known of how to involve families in physical activity (PA) interventions for children. In this cluster randomized controlled trial, we recruited families with four- to seven-year-old children to participate in a year-long study where parents in the intervention group families (n = 46) received tailored counseling to increase children’s PA. Structured PA was not served. Control group families (n = 45) did not receive any counseling. PA in all children (n = 91; mean age 6.16 ± 1.13 years at the baseline) was measured by accelerometers at the baseline and after three, six, nine and 12 months. Motor competence (MC) (n = 89) was measured at the baseline and after six and 12 months by a KTK (KörperkoordinationsTest für Kinder) and throwing and catching a ball (TCB) protocols. The effect of parental counseling on study outcomes was analyzed by a linear mixed-effects model fit by REML and by a Mann-Whitney U test in the case of the TCB. As season was hypothesized to affect counseling effect, an interaction of season on the study outcomes was examined. The results show significant decrease of MVPA in the intervention group when compared to the control group (p < .05). The TCB showed a nearly significant improvement at six months in the intervention group compared to the controls (p = .051), but not at 12 months. The intervention group had a steadier development of the KTK when the interaction of season was taken into account. In conclusion, more knowledge of family constructs associating with the effectiveness of counseling is needed for understanding how to enhance PA in children by parents. However, a hypothesis may be put forward that family-based counseling during an inactive season rather than an active season may provide a more lasting effect on the development of KTK in children. Trial Registration Controlled-Trials.com ISRCTN28668090 PMID:26502183

  7. A Trial by Trial Analysis Reveals More Intense Physical Activity is Associated with Better Cognitive Control Performance in Attention-Deficit/Hyperactivity Disorder

    PubMed Central

    Hartanto, T.A.; Krafft, C.E.; Iosif, A.M.; Schweitzer, J.B.

    2015-01-01

    Hyperactivity is a key symptom and the most observable manifestation of Attention-Deficit/Hyperactivity Disorder (ADHD). The over-activity associated with ADHD can cause specific challenges in academic settings, extracurricular activities and social relationships. Cognitive control challenges are also well-established in ADHD. The current study included 44 children between the ages of 10 and 17 diagnosed with ADHD or who were typically developing (TD), all of whom had no psychiatric co-morbidity or significant learning disorders. Participants wore an actometer on their ankle while performing a flanker paradigm in order to objectively measure their rates of activity in association with cognitive control. Analyses assessed the relationship between frequency and intensity of activity to task accuracy on trial by trial basis. A significant interaction effect between group and performance revealed that more intense movement was associated with better performance in the ADHD, but not TD group. The ADHD group demonstrated more intense activity than the TD group during correct (but not error) trials. Within-group, children with ADHD generated higher intensity movements in their correct trials compared to their error trials, whereas the TD group did not demonstrate any within-group differences. These findings suggest that excessive motoric activity associated with clinically significant ADHD symptoms may reflect compensatory efforts to modulate attention and alertness. Future research should systematically explore the relationship between motion in ADHD and how it might be used to improve cognitive performance. PMID:26059476

  8. A community-wide campaign to promote physical activity in middle-aged and elderly people: a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Background We aimed to evaluate the effectiveness of a community-wide campaign (CWC) for promoting physical activity in middle-aged and elderly people. Methods A cluster randomized controlled trial (RCT) with a community as the unit of randomization was performed using a population-based random-sampled evaluation by self-administered questionnaires in the city of Unnan, Shimane Prefecture, Japan. The evaluation sample included 6000 residents aged 40 to 79 years. We randomly allocated nine communities to the intervention group and three to the control group. The intervention was a CWC from 2009 to 2010 to promote physical activity, and it comprised information, education, and support delivery. The primary outcome was a change in engaging in regular aerobic, flexibility, and/or muscle-strengthening activities evaluated at the individual level. Results In total, 4414 residents aged 40–79 years responded to a self-administered questionnaire (73.6% response rate). Awareness of the CWC was 79% in the intervention group. Awareness and knowledge were significantly different between the intervention and control groups, although there were no significant differences in belief and intention. The 1-year CWC did not significantly promote the recommended level of physical activity (adjusted odds ratio: 0.97; 95% confidence interval: 0.84–1.14). Conclusions This cluster RCT showed that the CWC did not promote physical activity in 1 year. Significant differences were observed in awareness and knowledge between intervention and control groups as short-term impacts of the campaign. Trial registration UMIN-CTR UMIN000002683 PMID:23570536

  9. Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol

    PubMed Central

    2012-01-01

    -efficacy). Discussion The proposed study is novel, in that it represents a multi-disciplinary effort to merge two promising lines of research on MS: fatigue management and physical activity promotion. Collectively, the proposed study will be the largest randomized controlled trial to examine the effects of a lifestyle physical activity intervention in people with MS. Trial registration NCT01572714 PMID:23072517

  10. Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial

    PubMed Central

    Gay, Caryl; Haskell, William; Arai, Shoshana; Vittinghoff, Eric

    2015-01-01

    Background The mobile phone-based physical activity education (mPED) trial is a randomized controlled trial (RCT) evaluating a mobile phone-delivered physical activity intervention for women. The study includes a run-in period to maximize the internal validity of the intervention trial, but little is known about factors related to successful run-in completion, and thus about potential threats to external validity. Objective Objectives of this study are (1) to determine the timing of dropout during the run-in period, reasons for dropout, optimum run-in duration, and relevant run-in components, and (2) to identify predictors of failure to complete the run-in period. Methods A total of 318 physically inactive women met preliminary eligibility criteria and were enrolled in the study between May 2011 and April 2014. A 3-week run-in period was required prior to randomization and included using a mobile phone app and wearing a pedometer. Cross-sectional analysis identified predictors of dropout. Results Out of 318 participants, 108 (34.0%) dropped out prior to randomization, with poor adherence using the study equipment being the most common reason. Median failure time was 17 days into the run-in period. In univariate analyses, nonrandomized participants were younger, had lower income, were less likely to drive regularly, were less likely to have used a pedometer prior to the study, were generally less healthy, had less self-efficacy for physical activity, and reported more depressive symptoms than randomized participants. In multivariate competing risks models, not driving regularly in the past month and not having used a pedometer prior to the study were significantly associated with failure to be randomized (P=.04 and .006, respectively), controlling for age, race/ethnicity, education, shift work, and use of a study-provided mobile phone. Conclusions Regular driving and past pedometer use were associated with reduced dropout during the prerandomization run-in period

  11. Kinematic analysis of healthy hips during weight-bearing activities by 3D-to-2D model-to-image registration technique.

    PubMed

    Hara, Daisuke; Nakashima, Yasuharu; Hamai, Satoshi; Higaki, Hidehiko; Ikebe, Satoru; Shimoto, Takeshi; Hirata, Masanobu; Kanazawa, Masayuki; Kohno, Yusuke; Iwamoto, Yukihide

    2014-01-01

    Dynamic hip kinematics during weight-bearing activities were analyzed for six healthy subjects. Continuous X-ray images of gait, chair-rising, squatting, and twisting were taken using a flat panel X-ray detector. Digitally reconstructed radiographic images were used for 3D-to-2D model-to-image registration technique. The root-mean-square errors associated with tracking the pelvis and femur were less than 0.3 mm and 0.3° for translations and rotations. For gait, chair-rising, and squatting, the maximum hip flexion angles averaged 29.6°, 81.3°, and 102.4°, respectively. The pelvis was tilted anteriorly around 4.4° on average during full gait cycle. For chair-rising and squatting, the maximum absolute value of anterior/posterior pelvic tilt averaged 12.4°/11.7° and 10.7°/10.8°, respectively. Hip flexion peaked on the way of movement due to further anterior pelvic tilt during both chair-rising and squatting. For twisting, the maximum absolute value of hip internal/external rotation averaged 29.2°/30.7°. This study revealed activity dependent kinematics of healthy hip joints with coordinated pelvic and femoral dynamic movements. Kinematics' data during activities of daily living may provide important insight as to the evaluating kinematics of pathological and reconstructed hips.

  12. Protocol for the "four steps to control your fatigue (4-STEPS)" randomised controlled trial: a self-regulation based physical activity intervention for patients with unexplained chronic fatigue

    PubMed Central

    2012-01-01

    Background Unexplained Chronic Fatigue is a medical condition characterized by the presence of persistent, severe and debilitating medically unexplained fatigue, leading to impaired functioning and lower quality of life. Research suggests that physical activity can contribute to the reduction of fatigue and other somatic symptoms and can thus significantly improve physical functioning and quality of life in these patients. Based on the self-regulation (SR) theory of behaviour change, we developed a brief physical activity program for patients suffering from unexplained chronic fatigue which focuses on the training of self-regulation skills, the "4-STEPS to control your fatigue" program. Methods/Design This is a multi-centre, randomised controlled trial (RCT) that will be carried out in local primary care centres and at the Portuguese Fibromyalgia and Chronic Fatigue Syndrome Patients Association. Patients aged between 18 and 65 and fulfilling operationalized criteria for Idiopathic Chronic Fatigue (ICF) and Chronic Fatigue Syndrome (CFS) will be recruited and randomly allocated to standard care (SC) or standard care plus a self-regulation based physical activity program (4-STEPS). Patients will be assessed at baseline, after the intervention (3 months) and at 12 months follow-up. The primary outcome is fatigue severity. Discussion The results of the RCT will provide information about the effectiveness of a brief self-regulation intervention for promoting physical activity in patients with unexplained chronic fatigue. If the program proves to be effective, it may be considered as an adjunctive treatment for these patients. Trial Registration ISRCTN: ISRCTN70763996 PMID:22429404

  13. Preventing Obesity Among Adolescent Girls: One-Year Outcomes of the Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) Cluster Randomized Controlled Trial.

    PubMed

    Lubans, David R; Morgan, Philip J; Okely, Anthony D; Dewar, Deborah; Collins, Clare E; Batterham, Marijka; Callister, Robin; Plotnikoff, Ronald C

    2012-09-01

    OBJECTIVE To evaluate the impact of a 12-month multicomponent school-based obesity prevention program, Nutrition and Enjoyable Activity for Teen Girls among adolescent girls. DESIGN Group randomized controlled trial with 12-month follow-up. SETTING Twelve secondary schools in low-income communities in the Hunter and Central Coast regions of New South Wales, Australia. PARTICIPANTS Three hundred fifty-seven adolescent girls aged 12 to 14 years. INTERVENTION A multicomponent school-based intervention program tailored for adolescent girls. The intervention was based on social cognitive theory and included teacher professional development, enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity sessions, handbooks and pedometers for self-monitoring, parent newsletters, and text messaging for social support. MAIN OUTCOME MEASURES Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), BMI z score, body fat percentage, physical activity, screen time, dietary intake, and self-esteem. RESULTS After 12 months, changes in BMI (adjusted mean difference, -0.19; 95% CI, -0.70 to 0.33), BMI z score (mean, -0.08; 95% CI, -0.20 to 0.04), and body fat percentage (mean, -1.09; 95% CI, -2.88 to 0.70) were in favor of the intervention, but they were not statistically different from those in the control group. Changes in screen time were statistically significant (mean, -30.67 min/d; 95% CI, -62.43 to -1.06), but there were no group by time effects for physical activity, dietary behavior, or self-esteem. CONCLUSIONS A school-based intervention tailored for adolescent girls from schools located in low-income communities did not significantly reduce BMI gain. However, changes in body composition were of a magnitude similar to previous studies and may be associated with clinically important health outcomes. TRIAL REGISTRATION anzctr.org.au Identifier: 12610000330044.

  14. Activity and Life After Survival of a Cardiac Arrest (ALASCA) and the effectiveness of an early intervention service: design of a randomised controlled trial

    PubMed Central

    Moulaert, Véronique RMP; Verbunt, Jeanine A; van Heugten, Caroline M; Bakx, Wilbert GM; Gorgels, Anton PM; Bekkers, Sebastiaan CAM; de Krom, Marc CFTM; Wade, Derick T

    2007-01-01

    Background Cardiac arrest survivors may experience hypoxic brain injury that results in cognitive impairments which frequently remain unrecognised. This may lead to limitations in daily activities and participation in society, a decreased quality of life for the patient, and a high strain for the caregiver. Publications about interventions directed at improving quality of life after survival of a cardiac arrest are scarce. Therefore, evidence about effective rehabilitation programmes for cardiac arrest survivors is urgently needed. This paper presents the design of the ALASCA (Activity and Life After Survival of a Cardiac Arrest) trial, a randomised, controlled clinical trial to evaluate the effects of a new early intervention service for survivors of a cardiac arrest and their caregivers. Methods/design The study population comprises all people who survive two weeks after a cardiac arrest and are admitted to one of the participating hospitals in the Southern part of the Netherlands. In a two-group randomised, controlled clinical trial, half of the participants will receive an early intervention service. The early intervention service consists of several consultations with a specialised nurse for the patient and their caregiver during the first three months after the cardiac arrest. The intervention is directed at screening for cognitive problems, provision of informational, emotional and practical support, and stimulating self-management. If necessary, referral to specialised care can take place. Persons in the control group will receive the care as usual. The primary outcome measures are the extent of participation in society and quality of life of the patient one year after a cardiac arrest. Secondary outcome measures are the level of cognitive, emotional and cardiovascular impairment and daily functioning of the patient, as well as the strain for and quality of life of the caregiver. Participants and their caregivers will be followed for twelve months after the

  15. Promoting healthy eating, active play and sustainability consciousness in early childhood curricula, addressing the Ben10™ problem: a randomised control trial

    PubMed Central

    2014-01-01

    Background This paper details the research protocol for a study funded by the Australian Research Council. An integrated approach towards helping young children respond to the significant pressures of ‘360 degree marketing’ on their food choices, levels of active play, and sustainability consciousness via the early childhood curriculum is lacking. The overall goal of this study is to evaluate the efficacy of curriculum interventions that educators design when using a pedagogical communication strategy on children’s knowledge about healthy eating, active play and the sustainability consequences of their toy food and toy selections. Methods/Design This cluster-randomised trial will be conducted with 300, 4 to 5 year-old children attending pre-school. Early childhood educators will develop a curriculum intervention using a pedagogical communication strategy that integrates content knowledge about healthy eating, active play and sustainability consciousness and deliver this to their pre-school class. Children will be interviewed about their knowledge of healthy eating, active play and the sustainability consequences of their food and toy selections. Parents will complete an Eating and Physical Activity Questionnaire rating their children’s food preferences, digital media viewing and physical activity habits. All measures will be administered at baseline, the end of the intervention and 6 months post intervention. Informed consent will be obtained from all parents and the pre-school classes will be allocated randomly to the intervention or wait-list control group. Discussion This study is the first to utilise an integrated pedagogical communication strategy developed specifically for early childhood educators focusing on children’s healthy eating, active play, and sustainability consciousness. The significance of the early childhood period, for young children’s learning about healthy eating, active play and sustainability, is now unquestioned. The specific

  16. Exploring equity in uptake of the NHS Health Check and a nested physical activity intervention trial

    PubMed Central

    Attwood, S.; Morton, K.; Sutton, S.

    2016-01-01

    Background Socio-demographic factors characterizing disadvantage may influence uptake of preventative health interventions such as the NHS Health Check and research trials informing their content. Methods A cross-sectional study examining socio-demographic characteristics of participants and non-participants to the NHS Health Check and a nested trial of very brief physical activity interventions within this context. Age, gender, Index of Multiple Deprivation (IMD) and ethnicity were extracted from patient records of four General Practices (GP) in England. Results In multivariate analyses controlling for GP surgery, the odds of participation in the Health Check were higher for older patients (OR 1.05, 95% CI 1.04–1.07) and lower from areas of greater deprivation (IMD Quintiles 4 versus 1, OR 0.37, 95% CI 0.18–0.76, 5 versus 1 OR 0.42, 95% CI 0.20–0.88). Older patients were more likely to participate in the physical activity trial (OR 1.04, 95% CI 1.02–1.06). Conclusions Younger patients and those living in areas of greater deprivation may be at risk of non-participation in the NHS Health Check, while younger age also predicted non-participation in a nested research trial. The role that GP-surgery-specific factors play in influencing participation across different socio-demographic groups requires further exploration. PMID:26036701

  17. Clinical efficacy and mechanistic evaluation of aflibercept for proliferative diabetic retinopathy (acronym CLARITY): a multicentre phase IIb randomised active-controlled clinical trial

    PubMed Central

    Sivaprasad, Sobha; Prevost, A Toby; Bainbridge, James; Edwards, Rhiannon Tudor; Hopkins, David; Kelly, Joanna; Luthert, Phil; Murphy, Caroline; Ramu, Jayashree; Sarafraz-Shekary, Negin; Vasconcelos, Joana; White-Alao, Beverley; Hykin, Philip

    2015-01-01

    Introduction Proliferative diabetic retinopathy (PDR) is the main cause of severe visual loss in people with diabetes mellitus. The standard treatment for this condition is panretinal photocoagulation (PRP). This laser treatment is inherently destructive, with predictable adverse effects on visual function, and a safer alternative is required. Intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors can induce short-term regression of retinal neovascularisation. The aim of this randomised controlled trial is to determine the efficacy, safety and cost-effectiveness of intravitreal aflibercept, an inhibitor of VEGF-A, VEGF-B and placental growth factor (PLGF), in PDR, and to investigate the impact on local oxygenation. Methods and analysis This is a phase IIb randomised controlled single-masked multicentre clinical trial to determine the impact of repeated intravitreal aflibercept injections in the treatment and prevention of PDR. 220 participants with treatment-naïve or treated but active retinal neovascularisation in at least one eye will be randomly allocated 1:1 to intravitreal aflibercept injections or PRP for a period of 52 weeks. The primary outcome is the change in best-corrected visual acuity in the study eye at 52 weeks. Secondary outcomes include changes from baseline in other visual functions, anatomical changes and cost-effectiveness. Ocular and non-ocular adverse events will also be reported over 52 weeks. Ethics and dissemination The study has been approved by the National Research Ethics Service (NRES) committee with respect to scientific content and compliance with applicable research and human subjects’ regulations. Findings will be reported through scientific publications and research conferences. The results of this study will provide clinical evidence for the feasibility, efficacy safety and cost-effectiveness of intravitreal aflibercept for PDR. Trial registration number ISRCTN 32207582. PMID:26369798

  18. A New Mother-Child Play Activity Program to Decrease Parenting Stress and Improve Child Cognitive Abilities: A Cluster Randomized Controlled Trial

    PubMed Central

    Tachibana, Yoshiyuki; Fukushima, Ai; Saito, Hitomi; Yoneyama, Satoshi; Ushida, Kazuo; Yoneyama, Susumu; Kawashima, Ryuta

    2012-01-01

    Background We propose a new play activity intervention program for mothers and children. Our interdisciplinary program integrates four fields of child-related sciences: neuroscience, preschool pedagogy, developmental psychology, and child and maternal psychiatry. To determine the effect of this intervention on child and mother psychosocial problems related to parenting stress and on the children's cognitive abilities, we performed a cluster randomized controlled trial. Methodology/Principal Findings Participants were 238 pairs of mothers and typically developing preschool children (ages 4–6 years old) from Wakakusa kindergarten in Japan. The pairs were asked to play at home for about 10 min a day, 5 days a week for 3 months. Participants were randomly assigned to the intervention or control group by class unit. The Parenting Stress Index (PSI) (for mothers), the Goodenough Draw-a-Man intelligence test (DAM), and the new S-S intelligence test (NS-SIT) (for children) were administered prior to and 3 months after the intervention period. Pre–post changes in test scores were compared between the groups using a linear mixed-effects model analysis. The primary outcomes were the Total score on the child domain of the PSI (for child psychosocial problems related to parenting stress), Total score on the parent domain of the PSI (for maternal psychosocial problems related to parenting stress), and the score on the DAM (for child cognitive abilities). The results of the PSI suggested that the program may reduce parenting stress. The results of the cognitive tests suggested that the program may improve the children's fluid intelligence, working memory, and processing speed. Conclusions/Significance Our intervention program may ameliorate the children's psychosocial problems related to parenting stress and increase their cognitive abilities. Trial Registration UMIN Clinical Trials Registry UMIN000002265 PMID:22848340

  19. Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study)

    PubMed Central

    2014-01-01

    Background The aging of the population has led to the increase of chronic diseases, especially dementia and cardiovascular diseases, and it has become necessary for their relatives to dedicate more time in caregiving. The objective in the first phase of this study is to evaluate the effectiveness of a Primary Health Care procedure to increase the physical activity of people with dementia and their relative caregivers. Also the effect on the cognitive state and cardiovascular risk will be assessed. Methods/Design Design: Clinical, multicentric and randomized trial. A simple random sampling to select 134 patients diagnosed with dementia will be carried out. After contacting their relatives, his/her participation in the trial will be requested. A basal assessment will be made and the participants will be asigned to control or intervention group (1:1). Variables: The main measure will be the assessment of physical activity (podometer and 7-PAR) in patients and caregivers. In patients with dementia: ADAS-cog, functional degree and cardiovascular risk. In caregivers: cardiovascular risk, general health and quality of life. Intervention: For 3 months, participants will receive instructions to do physical activity with an adapted program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and their caregivers. The control group will receive regular care. Analysis: An intention-to-treat analysis will be carried out by comparing the observed differences between basal, 6 and 12 months measures. Change in the mean of daily steps assessed with the podometer and 7-PAR will be the main result. Discussion If the main hypothesis is confirmed, it could be useful to improve the cognitive state of patients with dementia, as well as the cardiovascular risk of all of them. The results can be good to improve technical features of the devices that register the physical activity in the patients with dementia, and it could facilitate

  20. Effects of a Web-Based Personalized Intervention on Physical Activity in European Adults: A Randomized Controlled Trial

    PubMed Central

    Celis-Morales, Carlos; Fallaize, Rosalind; Macready, Anna L; Kolossa, Silvia; Woolhead, Clara; O'Donovan, Clare B; Forster, Hannah; Navas-Carretero, Santiago; San-Cristobal, Rodrigo; Lambrinou, Christina-Paulina; Moschonis, George; Surwillo, Agnieszka; Godlewska, Magdalena; Goris, Annelies; Hoonhout, Jettie; Drevon, Christian A; Manios, Yannis; Traczyk, Iwona; Walsh, Marianne C; Gibney, Eileen R; Brennan, Lorraine; Martinez, J Alfredo; Lovegrove, Julie A; Gibney, Michael J; Daniel, Hannelore; Mathers, John C; Saris, Wim HM

    2015-01-01

    measured physical activity level (P<.05), moderate PA (P<.01), and sedentary time (P<.001) for individuals advised to increase PA, but these changes were similar across all groups. Conclusions Different levels of personalization produced similar small changes in objective PA. We found no evidence that personalized advice is more effective than conventional “one size fits all” guidelines to promote changes in PA in our Web-based intervention when PA was measured objectively. Based on self-reports, PA increased to a greater extent with more personalized advice. Thus, it is crucial to measure PA objectively in any PA intervention study. Trial Registration ClinicalTrials.gov NCT01530139; http://clinicaltrials.gov/show/NCT01530139 (Archived by WebCite at: http://www.webcitation.org/6XII1QwHz) PMID:26467573

  1. The study protocol of a cluster-randomised controlled trial of family-mediated personalised activities for nursing home residents with dementia

    PubMed Central

    2012-01-01

    symptoms, and a better quality of life than carers in the waiting list condition. Discussion We hypothesise that training family carers to deliver personalised activities to their relatives in a residential setting will make visits more satisfying and may consequently improve the quality of life for carers and their relatives. These beneficial effects might also reduce nursing staff burden and thus impact positively on residential facilities. Trial Registration Australian New Zealand Clinical Trials Registry - ACTRN12611000998943 PMID:22236064

  2. Long-range neural activity evoked by premotor cortex stimulation: a TMS/EEG co-registration study

    PubMed Central

    Zanon, Marco; Battaglini, Piero P.; Jarmolowska, Joanna; Pizzolato, Gilberto; Busan, Pierpaolo

    2013-01-01

    The premotor cortex is one of the fundamental structures composing the neural networks of the human brain. It is implicated in many behaviors and cognitive tasks, ranging from movement to attention and eye-related activity. Therefore, neural circuits that are related to premotor cortex have been studied to clarify their connectivity and/or role in different tasks. In the present work, we aimed to investigate the propagation of the neural activity evoked in the dorsal premotor cortex using transcranial magnetic stimulation/electroencephalography (TMS/EEG). Toward this end, interest was focused on the neural dynamics elicited in long-ranging temporal and spatial networks. Twelve healthy volunteers underwent a single-pulse TMS protocol in a resting condition with eyes closed, and the evoked activity, measured by EEG, was compared to a sham condition in a time window ranging from 45 ms to about 200 ms after TMS. Spatial and temporal investigations were carried out with sLORETA. TMS was found to induce propagation of neural activity mainly in the contralateral sensorimotor and frontal cortices, at about 130 ms after delivery of the stimulus. Different types of analyses showed propagated activity also in posterior, mainly visual, regions, in a time window between 70 and 130 ms. Finally, a likely “rebounding” activation of the sensorimotor and frontal regions, was observed in various time ranges. Taken together, the present findings further characterize the neural circuits that are driven by dorsal premotor cortex activation in healthy humans. PMID:24324426

  3. CSPP CDX Registration Guide

    EPA Pesticide Factsheets

    CDX allows users submitting data to the EPA to register for the specific program of interest. This Guide describes the registration process and information requirements associated with Submissions for the Chemical Safety and Pesticide Programs (CSPP).

  4. Lesson 6: Registration

    EPA Pesticide Factsheets

    Lesson 6 provides checklist items 1 through 4 are grouped under the Registration Process, where users establish their accounts in the system. This process typically requires users to provide information about them.

  5. Registration of Enlist Duo

    EPA Pesticide Factsheets

    EPA is proposing to amend the registration of Enlist Duo to allow use on GE cotton in the original 15 states and extend the use of Enlist Duo on GE corn, soybean and cotton to an additional 19 states.

  6. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  7. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  8. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  9. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  10. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  11. Addition of telephone coaching to a physiotherapist-delivered physical activity program in people with knee osteoarthritis: A randomised controlled trial protocol

    PubMed Central

    2012-01-01

    -up assessments will also occur at 12 and 18 months. Discussion The findings will help determine whether the addition of telephone coaching sessions can improve sustainability of outcomes from a physiotherapist-delivered physical activity intervention in people with knee OA. Trial Registration Australian New Zealand Clinical Trials Registry reference: ACTRN12612000308897 PMID:23231928

  12. Remote long-term registrations of sleep-wake rhythms, core body temperature and activity in marmoset monkeys.

    PubMed

    Hoffmann, Kerstin; Coolen, Alex; Schlumbohm, Christina; Meerlo, Peter; Fuchs, Eberhard

    2012-12-01

    Initial studies in the day active marmoset monkey (Callithrix jacchus) indicate that the sleep-wake cycle of these non-human primates resembles that of humans and therefore conceivably represent an appropriate model for human sleep. The methods currently employed for sleep studies in marmosets are limited. The objective of this study was to employ and validate the use of specific remote monitoring system technologies that enable accurate long-term recordings of sleep-wake rhythms and the closely related rhythms of core body temperature (CBT) and locomotor activity in unrestrained group-housed marmosets. Additionally, a pilot sleep deprivation (SD) study was performed to test the recording systems in an applied experimental setup. Our results show that marmosets typically exhibit a monophasic sleep pattern with cyclical alternations between NREM and REM sleep. CBT displays a pronounced daily rhythm and locomotor activity is primarily restricted to the light phase. SD caused an immediate increase in NREM sleep time and EEG slow-wave activity as well as a delayed REM sleep rebound that did not fully compensate for REM sleep that had been lost during SD. In conclusion, the combination of two innovative technical approaches allows for simultaneous measurements of CBT, sleep cycles and activity in multiple subjects. The employment of these systems represents a significant refinement in terms of animal welfare and will enable many future applications and longitudinal studies of circadian rhythms in marmosets.

  13. Interruption pf physcial activity due to illness in the Lifestyle Interventions and Indepencence for Elders Pilot (LIFE-P) trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) was a trial to examine the effects of physical activity (PA) compared to a health education control on measures of disability in sedentary older adults. Medical suspensions were examined for the first 12 months of the trial in th...

  14. Comparative Effectiveness Research Using Observational Data: Active Comparators to Emulate Target Trials with Inactive Comparators

    PubMed Central

    Huitfeldt, Anders; Hernan, Miguel A.; Kalager, Mette; Robins, James M.

    2016-01-01

    Introduction: Because a comparison of noninitiators and initiators of treatment may be hopelessly confounded, guidelines for the conduct of observational research often recommend using an “active” comparator group consisting of people who initiate a treatment other than the medication of interest. In this paper, we discuss the conditions under which this approach is valid if the goal is to emulate a trial with an inactive comparator. Identification of Effects: We provide conditions under which a target trial in a subpopulation can be validly emulated from observational data, using an active comparator that is known or believed to be inactive for the outcome of interest. The average treatment effect in the population as a whole is not identified, but under certain conditions this approach can be used to emulate a trial in the subset of individuals who were treated with the treatment of interest, in the subset of individuals who were treated with the treatment of interest but not with the comparator, or in the subset of individuals who were treated with both the treatment of interest and the active comparator. The Plausibility of the Comparability Conditions: We discuss whether the required conditions can be expected to hold in pharmacoepidemiologic research, with a particular focus on whether the conditions are plausible in situations where the standard analysis fails due to unmeasured confounding by access to health care or health seeking behaviors. Discussion: The conditions discussed in this paper may at best be approximately true. Investigators using active comparator designs to emulate trials with inactive comparators should exercise caution. PMID:27891526

  15. Effectiveness of a Worksite Social & Physical Environment Intervention on Need for Recovery, Physical Activity and Relaxation; Results of a Randomized Controlled Trial

    PubMed Central

    Coffeng, Jennifer K.; Boot, Cécile R. L.; Duijts, Saskia F. A.; Twisk, Jos W. R.; van Mechelen, Willem; Hendriksen, Ingrid J. M.

    2014-01-01

    itself could be improved by increasing the intensity of the intervention (for example weekly GMI-sessions), providing physical activity opportunities and exercise schemes, and by more drastic environment interventions (restructuring entire department floor). Trial Registration Nederlands Trial Register NTR2553 PMID:25542039

  16. Effectiveness of Computer Tailoring Versus Peer Support Web-Based Interventions in Promoting Physical Activity Among Insufficiently Active Canadian Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial

    PubMed Central

    Côté, José

    2016-01-01

    activity promotion in adult populations with type 2 diabetes. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN15747108; http://www.isrctn.com/ISRCTN15747108 (Archived by WebCite at http://www.webcitation.org/6eJTi0m3r) PMID:26869015

  17. The effectiveness of physical activity monitoring and distance counseling in an occupational setting – Results from a randomized controlled trial (CoAct)

    PubMed Central

    2012-01-01

    intervention group. An exploratory subgroup analysis revealed no subgroups in which the intervention affected physical activity. No adverse events were reported. Conclusions The intervention was not found effective, and this study does not provide support for the effectiveness of the workplace PA intervention used here. Trial registration ClinicalTrials.gov identifier: NCT00994565 PMID:22578104

  18. Physical activity as intervention for age-related loss of muscle mass and function: protocol for a randomised controlled trial (the LISA study)

    PubMed Central

    Eriksen, Christian Skou; Garde, Ellen; Reislev, Nina Linde; Wimmelmann, Cathrine Lawaetz; Bieler, Theresa; Ziegler, Andreas Kraag; Gylling, Anne Theil; Dideriksen, Kasper Juel; Siebner, Hartwig Roman; Mortensen, Erik Lykke; Kjaer, Michael

    2016-01-01

    Introduction Physical and cognitive function decline with age, accelerating during the 6th decade. Loss of muscle power (force×velocity product) is a dominant physical determinant for loss of functional ability, especially if the lower extremities are affected. Muscle strength training is known to maintain or even improve muscle power as well as physical function in older adults, but the optimal type of training for beneficial long-term training effects over several years is unknown. Moreover, the impact of muscle strength training on cognitive function and brain structure remains speculative. The primary aim of this randomised controlled trial is to compare the efficacy of two different 1 year strength training regimens on immediate and long-lasting improvements in muscle power in retirement-age individuals. Secondary aims are to evaluate the effect on muscle strength, muscle mass, physical and cognitive function, mental well-being, health-related quality of life and brain morphology. Methods and analysis The study includes 450 home-dwelling men and women (62–70 years). Participants are randomly allocated to (1) 1 year of supervised, centre-based heavy resistance training, (2) home-based moderate intensity resistance training or (3) habitual physical activity (control). Changes in primary (leg extensor power) and secondary outcomes are analysed according to the intention to treat principle and per protocol at 1, 2, 4, 7 and 10 years. Ethics and dissemination The study is expected to generate new insights into training-induced promotion of functional ability and independency after retirement and will help to formulate national recommendations regarding physical activity schemes for the growing population of older individuals in western societies. Results will be published in scientific peer-reviewed journals, in PhD theses and at public meetings. The study is approved by the Regional Ethical Committee (Capital Region, Copenhagen, Denmark, number H-3

  19. The Clinical Trial of Women On the Move through Activity and Nutrition (WOMAN Study)

    PubMed Central

    Kuller, Lewis H.; Kriska, Andrea M.; Kinzel, Laura S.; Simkin-Silverman, Laurey R.; Sutton-Tyrrell, Kim; Johnson, B. Delia; Conroy, Molly B.

    2007-01-01

    The Women On the Move through Activity and Nutrition (WOMAN) Study is the first randomized clinical trial of nonpharmacological intervention designed to modify lipoproteins, weight loss and exercise among postmenopausal women using noninvasive measures of atherosclerosis as the primary endpoint. The trial was initially designed to test whether intervention as compared to health education would be more effective in slowing progression of subclinical atherosclerosis among women on hormone therapy (HT), estrogen or estrogen+progestin. It was designed and implemented prior to the results of the Women's Health Initiative (WHI). The trial was since modified to include women who had been on HT but went off after the results of the WHI were reported. Eligible women were between the ages of 52-62, had waist circumference ≥80 cm, low density lipoprotein cholesterol between 100-160 mg% and controlled blood pressure. The intervention is low in total and saturated fat, trans fats, higher in fiber and promotes loss of 7-10% of body weight and includes at least 150 minutes of physical activity per week. The study has recruited 508 women. The primary endpoints are change in extent of carotid intima media wall thickness as measured by carotid ultrasound, pulse wave velocity as a measure of vascular stiffness and coronary artery calcium using electron beam computed tomography. Body composition is measured by dual-energy x-ray absorptiometry. PMID:17113831

  20. [Placebo control and clinical trial of Chinese medicine].

    PubMed

    Wu, Jing

    2010-10-01

    World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

  1. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Registration number. 47.15 Section 47.15... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application,...

  2. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Registration number. 47.15 Section 47.15... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application,...

  3. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Registration number. 47.15 Section 47.15... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application,...

  4. User Registration in EOSDIS

    NASA Astrophysics Data System (ADS)

    Murphy, K. J.; Mitchell, A. E.

    2009-12-01

    Throughout the lifetime of EOSDIS the topic of user registration has received varied attention. Initially, for example, users ordering data from the Earth Science Data Gateway were required to register for delivery of media orders, to check order status and save profile information for future interactions. As EOSDIS embraced evolution of its data systems, the mostly centralized search and order system was replaced with a more diverse set of interfaces allowing (mostly) anonymous online access to data, tools and services. The changes to EOSDIS were embraced by users but the anonymous nature of the interaction made it more difficult to characterize users, capture metrics and provide customized services that benefit users. Additionally, new tools and interfaces have been developed without a centralized registration system. Currently a patchwork of independent registration systems exists throughout EOSDIS for ordering data and interacting with online tools and services. Each requires a separate username and password that must be managed by users. A consolidation of registration systems presents an opportunity to improve not only the user experience through tool customization and simplification of password management, but the understanding of users. This work discusses the options for implementing a common user registration for the EOSDIS, anticipated benefits and pitfalls.

  5. Mediators Affecting Girls’ Levels of Physical Activity Outside of School: Findings from the Trial of Activity in Adolescent Girls

    PubMed Central

    Lytle, Leslie A.; Murray, David M.; Evenson, Kelly R.; Moody, Jamie; Pratt, Charlotte A.; Metcalfe, Lauve; Parra-Medina, Deborah

    2010-01-01

    Background Providing after school activities is a community level approach for reducing the decline in physical activity of girls as they reach early adolescence. Purpose The purpose of this study was to examine psychosocial, environmental, and behavioral factors as potential mediators of after school physical activity in adolescent girls. Methods We assessed objectively measured levels of physical activity occurring outside of school and potential predictors and mediators of activity in girls participating in the Trial of Activity in Adolescent Girls (TAAG). Results We found that the TAAG intervention had a statistically significant and positive effect on out of school activity in the 2006 cohort. Self-efficacy, friends’ social support, total social support, and difficulty getting to and from community activities mediated the level of moderate to vigorous physical activity in girls. Conclusions Parents, communities, and schools should provide and enhance opportunities outside of the school day for adolescents to be active. Reducing transportation barriers and enlisting social support appear to be key. PMID:20012810

  6. Single-trial prediction of reaction time variability from MEG brain activity

    PubMed Central

    Ohata, Ryu; Ogawa, Kenji; Imamizu, Hiroshi

    2016-01-01

    Neural activity prior to movement onset contains essential information for predictive assistance for humans using brain-machine-interfaces (BMIs). Even though previous studies successfully predicted different goals for upcoming movements, it is unclear whether non-invasive recording signals contain the information to predict trial-by-trial behavioral variability under the same movement. In this paper, we examined the predictability of subsequent short or long reaction times (RTs) from magnetoencephalography (MEG) signals in a delayed-reach task. The difference in RTs was classified significantly above chance from 550 ms before the go-signal onset using the cortical currents in the premotor cortex. Significantly above-chance classification was performed in the lateral prefrontal and the right inferior parietal cortices at the late stage of the delay period. Thus, inter-trial variability in RTs is predictable information. Our study provides a proof-of-concept of the future development of non-invasive BMIs to prevent delayed movements. PMID:27250872

  7. Principal stratification with predictors of compliance for randomized trials with 2 active treatments.

    PubMed

    Roy, Jason; Hogan, Joseph W; Marcus, Bess H

    2008-04-01

    In behavioral medicine trials, such as smoking cessation trials, 2 or more active treatments are often compared. Noncompliance by some subjects with their assigned treatment poses a challenge to the data analyst. The principal stratification framework permits inference about causal effects among subpopulations characterized by potential compliance. However, in the absence of prior information, there are 2 significant limitations: (1) the causal effects cannot be point identified for some strata and (2) individuals in the subpopulations (strata) cannot be identified. We propose to use additional information-compliance-predictive covariates-to help identify the causal effects and to help describe characteristics of the subpopulations. The probability of membership in each principal stratum is modeled as a function of these covariates. The model is constructed using marginal compliance models (which are identified) and a sensitivity parameter that captures the association between the 2 marginal distributions. We illustrate our methods in both a simulation study and an analysis of data from a smoking cessation trial.

  8. Image registration by parts

    NASA Technical Reports Server (NTRS)

    Chalermwat, Prachya; El-Ghazawi, Tarek; LeMoigne, Jacqueline

    1997-01-01

    In spite of the large number of different image registration techniques, most of these techniques use the correlation operation to match spatial image characteristics. Correlation is known to be one of the most computationally intensive operations and its computational needs grow rapidly with the increase in the image sizes. In this article, we show that, in many cases, it might be sufficient to determine image transformations by considering only one or several parts of the image rather than the entire image, which could result in substantial computational savings. This paper introduces the concept of registration by parts and investigates its viability. It describes alternative techniques for such image registration by parts and presents early empirical results that address the underlying trade-offs.

  9. Analysis of subpixel registration

    NASA Technical Reports Server (NTRS)

    Berenstein, C. A.; Kanal, L. N.; Lavine, D.; Olson, E. C.; Slud, E.

    1984-01-01

    The area of subpixel accuracy in image registration and edge detection was studied. Two main directions of research were pursued, edge detection and matching based on the digital geometry of edges, and random field models for probablistic analysis of registration error. In the edge detection approach, error bounds and error probabilities were computed using theoretical models. Algorithms were developed and tests on simulated imagery. The methods appear promising for high accuracy edge position estimation and registration, though further refinement of the procedures is required. Using random field models, a statistical measure of the quality of the cross correlation peak as an estimate of the offset between a sensed and a reference image was developed. Simulations were performed to determine the validity of this estimte with real imagery and to study the results of interpolating digital correlation functions to estimate the translation offset to subpixel accuracy.

  10. Towards operational multisensor registration

    NASA Technical Reports Server (NTRS)

    Rignot, Eric J. M.; Kwok, Ronald; Curlander, John C.

    1991-01-01

    To use data from a number of different remote sensors in a synergistic manner, a multidimensional analysis of the data is necessary. However, prior to this analysis, processing to correct for the systematic geometric distortion characteristic of each sensor is required. Furthermore, the registration process must be fully automated to handle a large volume of data and high data rates. A conceptual approach towards an operational multisensor registration algorithm is presented. The performance requirements of the algorithm are first formulated given the spatially, temporally, and spectrally varying factors that influence the image characteristics and the science requirements of various applications. Several registration techniques that fit within the structure of this algorithm are also presented. Their performance was evaluated using a multisensor test data set assembled from LANDSAT TM, SEASAT, SIR-B, Thermal Infrared Multispectral Scanner (TIMS), and SPOT sensors.

  11. The Pap smear screening as an occasion for smoking cessation and physical activity counselling: baseline characteristics of women involved in the SPRINT randomized controlled trial

    PubMed Central

    2011-01-01

    Background Gender-specific smoking cessation strategies have rarely been developed. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to smoking cessation programs is not strong. SPRINT study is a randomized controlled trial (RCT) designed to evaluate a counselling intervention on smoking cessation and PA delivered to women attending the Italian National Health System Cervical Cancer Screening Program. This paper presents study design and baseline characteristics of the study population. Methods/Design Among women undergoing the Pap examination in three study centres (Florence, Turin, Mantua), participants were randomized to the smoking cessation counselling [S], the smoking cessation + PA counselling [S + PA], or the control [C] groups. The program under evaluation is a standard brief counselling on smoking cessation combined with a brief counselling on increasing PA, and was delivered in 2010. A questionnaire, administered before, after 6 months and 1 year from the intervention, was used to track behavioural changes in tobacco use and PA, and to record cessation rates in participants. Discussion Out of the 5,657 women undergoing the Pap examination, 1,100 participants (55% of smokers) were randomized in 1 of the 3 study groups (363 in the S, 366 in the S + PA and 371 in the C groups). The three arms did not differ on any demographic, PA, or tobacco-use characteristics. Recruited smokers were older, less educated than non-participant women, more motivated to quit (33% vs.9% in the Preparation stage, p < 0.001), smoked more cigarettes per day (12 vs.9, p < 0.001), and were more likely to have already done 1 or more quit attempts (64% vs.50%, p < 0.001). The approach of SPRINT study appeared suitable to enrol less educated women who usually smoke more and have more difficulties to quit. Trial registration number ISRCTN: ISRCTN52660565 PMID:22151834

  12. Lifestyle Advice Combined with Personalized Estimates of Genetic or Phenotypic Risk of Type 2 Diabetes, and Objectively Measured Physical Activity: A Randomized Controlled Trial

    PubMed Central

    van Sluijs, Esther M. F.; Marteau, Theresa M.; Sutton, Stephen

    2016-01-01

    Background Information about genetic and phenotypic risk of type 2 diabetes is now widely available and is being incorporated into disease prevention programs. Whether such information motivates behavior change or has adverse effects is uncertain. We examined the effect of communicating an estimate of genetic or phenotypic risk of type 2 diabetes in a parallel group, open, randomized controlled trial. Methods and Findings We recruited 569 healthy middle-aged adults from the Fenland Study, an ongoing population-based, observational study in the east of England (Cambridgeshire, UK). We used a computer-generated random list to assign participants in blocks of six to receive either standard lifestyle advice alone (control group, n = 190) or in combination with a genetic (n = 189) or a phenotypic (n = 190) risk estimate for type 2 diabetes (intervention groups). After 8 wk, we measured the primary outcome, objectively measured physical activity (kJ/kg/day), and also measured several secondary outcomes (including self-reported diet, self-reported weight, worry, anxiety, and perceived risk). The study was powered to detect a between-group difference of 4.1 kJ/kg/d at follow-up. 557 (98%) participants completed the trial. There were no significant intervention effects on physical activity (difference in adjusted mean change from baseline: genetic risk group versus control group 0.85 kJ/kg/d (95% CI −2.07 to 3.77, p = 0.57); phenotypic risk group versus control group 1.32 (95% CI −1.61 to 4.25, p = 0.38); and genetic risk group versus phenotypic risk group −0.47 (95% CI −3.40 to 2.46, p = 0.75). No significant differences in self-reported diet, self-reported weight, worry, and anxiety were observed between trial groups. Estimates of perceived risk were significantly more accurate among those who received risk information than among those who did not. Key limitations include the recruitment of a sample that may not be representative of the UK population, use of self

  13. 77 FR 77077 - Pesticide Product Registration; Receipt of Applications for New Uses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-31

    ... AGENCY Pesticide Product Registration; Receipt of Applications for New Uses AGENCY: Environmental... pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide... Registration Division (RD) (7505P), Office of Pesticide Programs, Environmental Protection Agency,...

  14. 78 FR 55695 - Notice of Receipt of Pesticide Products; Registration Applications To Register New Uses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... AGENCY Notice of Receipt of Pesticide Products; Registration Applications To Register New Uses AGENCY... register new uses for pesticide products containing currently registered active ingredients pursuant to the...: Lois Rossi, Registration Division (RD), (7505P), Office of Pesticide Programs, Environmental...

  15. 78 FR 48677 - Notice of Receipt of Pesticide Products; Registration Applications to Register New Uses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... AGENCY Notice of Receipt of Pesticide Products; Registration Applications to Register New Uses AGENCY... register new uses for pesticide products containing currently registered active ingredients pursuant to the...: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental...

  16. Physical Activity Program Delivery by Professionals versus Volunteers: the TEAM Randomized Trial

    PubMed Central

    Castro, Cynthia M.; Pruitt, Leslie A.; Buman, Matthew P.; King, Abby C.

    2010-01-01

    Background Older adults have low rates of physical activity participation but respond positively to telephone-mediated support programs. Programs are often limited by reliance on professional staff. This study tested telephone-based physical activity advice delivered by professional staff versus trained volunteer peer mentors. Design A 12-month, randomized, controlled clinical trial was executed from 2003–2008. Setting/participants: Twelve volunteer peer mentors and 181 initially inactive adults ages 50 years and older were recruited from the San Francisco Bay Area. Intervention Participants were randomized to: (1) telephone-based physical activity advice delivered by professional staff, (2) telephone-based physical activity advice delivered by trained volunteer peers, or (3) an attention-control arm of staff-delivered telephone support for nutrition. Main Outcome Measures: Moderate-intensity or more vigorous physical activity (MVPA) was assessed at baseline, 6, and 12 months with the CHAMPS Questionnaire, with accelerometry validation (Actigraph) in a randomly selected subsample. Treatment fidelity was examined through analysis of quantity and quality of intervention delivery. Results At 6 and 12 months, both physical activity arms significantly increased MVPA relative to the control arm. Both physical activity arms were comparable in quantity of intervention delivery, but peers demonstrated more versatility and comprehensiveness in quality of intervention content. Conclusions This study demonstrates that trained peer volunteers can effectively promote physical activity increases through telephone-based advice. The results support a program delivery model with good dissemination potential for a variety of community settings. PMID:21553972

  17. Registration Documents for Enlist Duo Herbicide (2014)

    EPA Pesticide Factsheets

    See details of the registration of Enlist Duo in 2014, including the notification to the registrant, the details of the assessment and registration decision, and the response to public comment on the proposed registration.

  18. A cluster-randomized controlled trial to reduce sedentary behavior and promote physical activity and health of 8-9 year olds: The Transform-Us! Study

    PubMed Central

    2011-01-01

    Background Physical activity (PA) is associated with positive cardio-metabolic health and emerging evidence suggests sedentary behavior (SB) may be detrimental to children's health independent of PA. The primary aim of the Transform-Us! study is to determine whether an 18-month, behavioral and environmental intervention in the school and family settings results in higher levels of PA and lower rates of SB among 8-9 year old children compared with usual practice (post-intervention and 12-months follow-up). The secondary aims are to determine the independent and combined effects of PA and SB on children's cardio-metabolic health risk factors; identify the factors that mediate the success of the intervention; and determine whether the intervention is cost-effective. Methods/design A four-arm cluster-randomized controlled trial (RCT) with a 2 × 2 factorial design, with schools as the unit of randomization. Twenty schools will be allocated to one of four intervention groups, sedentary behavior (SB-I), physical activity (PA-I), combined SB and PA (SB+PA-I) or current practice control (C), which will be evaluated among approximately 600 children aged 8-9 years in school year 3 living in Melbourne, Australia. All children in year 3 at intervention schools in 2010 (8-9 years) will receive the intervention over an 18-month period with a maintenance 'booster' delivered in 2012 and children at all schools will be invited to participate in the evaluation assessments. To maximize the sample and to capture new students arriving at intervention and control schools, recruitment will be on-going up to the post-intervention time point. Primary outcomes are time spent sitting and in PA assessed via accelerometers and inclinometers and survey. Discussion To our knowledge, Transform-Us! is the first RCT to examine the effectiveness of intervention strategies for reducing children's overall sedentary time, promoting PA and optimizing health outcomes. The integration of consistent

  19. Distributed Continuous Registration.

    ERIC Educational Resources Information Center

    Myers, Donald L.

    1981-01-01

    The development, implementation, and features of Northern Colorado's continuous registration system are described. The system is an online distributed processing system, written in COBOL for an IBM Series I under the CPS operating system. Course selection, permit to enroll, and drop/add forms are provided. (Author/MLW)

  20. Registration Priorities: A Report.

    ERIC Educational Resources Information Center

    Walters, Judy E.

    In May 1993, the California Community Colleges' Board of Governors adopted systemwide guidelines recommending student registration priorities to help address current discrepancies between available resources and courses and the colleges' open-door mission. This report describes the guidelines and results of a study conducted to determine their…

  1. Earth Science Imagery Registration

    NASA Technical Reports Server (NTRS)

    LeMoigne, Jacqueline; Morisette, Jeffrey; Cole-Rhodes, Arlene; Johnson, Kisha; Netanyahu, Nathan S.; Eastman, Roger; Stone, Harold; Zavorin, Ilya

    2003-01-01

    The study of global environmental changes involves the comparison, fusion, and integration of multiple types of remotely-sensed data at various temporal, radiometric, and spatial resolutions. Results of this integration may be utilized for global change analysis, as well as for the validation of new instruments or for new data analysis. Furthermore, future multiple satellite missions will include many different sensors carried on separate platforms, and the amount of remote sensing data to be combined is increasing tremendously. For all of these applications, the first required step is fast and automatic image registration, and as this need for automating registration techniques is being recognized, it becomes necessary to survey all the registration methods which may be applicable to Earth and space science problems and to evaluate their performances on a large variety of existing remote sensing data as well as on simulated data of soon-to-be-flown instruments. In this paper we present one of the first steps toward such an exhaustive quantitative evaluation. First, the different components of image registration algorithms are reviewed, and different choices for each of these components are described. Then, the results of the evaluation of the corresponding algorithms combining these components are presented o n several datasets. The algorithms are based on gray levels or wavelet features and compute rigid transformations (including scale, rotation, and shifts). Test datasets include synthetic data as well as data acquired over several EOS Land Validation Core Sites with the IKONOS and the Landsat-7 sensors.

  2. Registration Study. Research Note.

    ERIC Educational Resources Information Center

    Baratta, Mary Kathryne

    During spring 1977 registration, 3,255 or 45% of Moraine Valley Community College (MVCC) registering students responded to a scheduling preferences and problems questionnaire covering enrollment status, curriculum load, program preference, ability to obtain courses, schedule conflicts, preferred times for class offerings, actual scheduling of…

  3. CUNY's Voter Registration System.

    ERIC Educational Resources Information Center

    Hershenson, Jay; And Others

    This collection of items including public testimony by the Vice Chancellor, Jay Hershenson, a formal resolution, a press release, and brochures, documents the City University of New York's (CUNY) unique voter registration system, "CUNY Project Vote". As the press release describes it, Project Vote is the nation's largest student voter…

  4. Pilot Randomised Controlled Trial of a Web-Based Intervention to Promote Healthy Eating, Physical Activity and Meaningful Social Connections Compared with Usual Care Control in People of Retirement Age Recruited from Workplaces

    PubMed Central

    Lara, Jose; O’Brien, Nicola; Godfrey, Alan; Heaven, Ben; Evans, Elizabeth H.; Lloyd, Scott; Moffatt, Suzanne; Moynihan, Paula J.; Meyer, Thomas D.; Rochester, Lynn; Sniehotta, Falko F.; White, Martin; Mathers, John C.

    2016-01-01

    Background Lifestyle interventions delivered during the retirement transition might promote healthier ageing. We report a pilot randomised controlled trial (RCT) of a web-based platform (Living, Eating, Activity and Planning through retirement; LEAP) promoting healthy eating (based on a Mediterranean diet (MD)), physical activity (PA) and meaningful social roles. Methods A single blinded, two-arm RCT with individual allocation. Seventy-five adult regular internet users living in Northeast England, within two years of retirement, were recruited via employers and randomised in a 2:1 ratio to receive LEAP or a ‘usual care’ control. Intervention arm participants were provided with a pedometer to encourage self-monitoring of PA goals. Feasibility of the trial design and procedures was established by estimating recruitment and retention rates, and of LEAP from usage data. At baseline and 8-week follow-up, adherence to a MD derived from three 24-hour dietary recalls and seven-day PA by accelerometry were assessed. Healthy ageing outcomes (including measures of physiological function, physical capability, cognition, psychological and social wellbeing) were assessed and acceptability established by compliance with measurement protocols and completion rates. Thematically analysed, semi-structured, qualitative interviews assessed acceptability of the intervention, trial design, procedures and outcome measures. Results Seventy participants completed the trial; 48 (96%) participants in the intervention and 22 (88%) in the control arm. Participants had considerable scope for improvement in diet as assessed by MD score. LEAP was visited a median of 11 times (range 1–80) for a mean total time of 2.5 hours (range 5.5 min– 8.3 hours). ‘Moving more‘, ‘eating well’ and ‘being social’ were the most visited modules. At interview, participants reported that diet and PA modules were important and acceptable within the context of healthy ageing. Participants found both

  5. Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency.

    PubMed

    Dal-Ré, Rafael; Moher, David; Gluud, Christian; Treweek, Shaun; Demotes-Mainard, Jacques; Carné, Xavier

    2011-12-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.

  6. The hidden KPI registration accuracy.

    PubMed

    Shorrosh, Paul

    2011-09-01

    Determining the registration accuracy rate is fundamental to improving revenue cycle key performance indicators. A registration quality assurance (QA) process allows errors to be corrected before bills are sent and helps registrars learn from their mistakes. Tools are available to help patient access staff who perform registration QA manually.

  7. 77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services... FR 60143, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made... listed substances for analytical research and clinical trials. No comments or objections have...

  8. Sedentary Activity and Body Composition of Middle School Girls: The Trial of Activity for Adolescent Girls

    ERIC Educational Resources Information Center

    Pratt, Charlotte; Webber, Larry S.; Baggett, Chris D.; Ward, Dianne; Pate, Russell R.; Murray, David; Lohman, Timothy; Lytle, Leslie; Elder, John P.

    2008-01-01

    This study describes the relationships between sedentary activity and body composition in 1,458 sixth-grade girls from 36 middle schools across the United States. Multivariate associations between sedentary activity and body composition were examined with regression analyses using general linear mixed models. Mean age, body mass index, and…

  9. Feasibility and Acceptability of a Wearable Technology Physical Activity Intervention With Telephone Counseling for Mid-Aged and Older Adults: A Randomized Controlled Pilot Trial

    PubMed Central

    Swartz, Maria C; Lewis, Zakkoyya H; Martinez, Eloisa; Jennings, Kristofer

    2017-01-01

    =0.35), steps per day (d=0.26), sitting time per day (d=0.21), body fat (d=0.17), and weight (d=0.33). Conclusions The intervention was feasible and acceptable in this population. Effect sizes were similar to the sizes found using other wearable electronic activity monitors, indicating that when combined with telephone counseling, wearable activity monitors are a potentially effective tool for increasing physical activity and decreasing sedentary behavior. Trial registration Clinicaltrials.gov NCT01869348; https://clinicaltrials.gov/ct2/show/NCT01869348 (Archived by WebCite at http://www.webcitation.org/6odlIolqy) PMID:28264796

  10. Promotion of Physical Activity Among High-School Girls: A Randomized Controlled Trial

    PubMed Central

    Pate, Russell R.; Ward, Dianne S.; Saunders, Ruth P.; Felton, Gwen; Dishman, Rod K.; Dowda, Marsha

    2005-01-01

    Objectives. Many adolescent girls fail to meet national guidelines for physical activity, and the prevalence of obesity is increasing among this group. Our study examined the effects of a comprehensive school-based intervention on physical activity among high-school girls. Methods. A group-randomized controlled field trial was conducted at 24 high schools. A school-based sample of 2744 girls (48.7% African American, 46.7% White) participated in a measurement protocol when they were in eighth and then ninth grade. A comprehensive physical activity intervention was designed to change the instructional program and the school environment to increase support for physical activity among girls. Results. At follow-up, 45% of girls in the intervention schools and 36% of girls in the control schools reported vigorous physical activity during an average of 1 or more 30-minute time blocks per day over a 3-day period. Conclusions. A comprehensive school-based intervention can increase regular participation in vigorous physical activity among high-school girls. PMID:16118370

  11. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. (a) The registration of an...) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under paragraph...

  12. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 6 2011-07-01 2011-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  13. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 6 2013-07-01 2013-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  14. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  15. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. (a) The registration of an...) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under paragraph...

  16. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. (a) The registration of an...) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under paragraph...

  17. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 6 2014-07-01 2014-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  18. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 6 2012-07-01 2012-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  19. 75 FR 10312 - Importer of Controlled Substances; Notice of Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-05

    ... importer of Fentanyl (9801), a basic class of controlled substance listed in schedule II. The company plans... for distribution to clinical trial sites. No comments or objections have been received. DEA has... company's registration is consistent with the public interest. The investigation has included...

  20. The fitness for the Ageing Brain Study II (FABS II): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer's disease

    PubMed Central

    2010-01-01

    Background Observational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer's disease. The Fitness for the Ageing Brain II (FABS II) study is a multicentre randomized controlled clinical trial (RCT) aiming to determine whether physical activity reduces the rate of cognitive decline among individuals with Alzheimer's disease. This paper describes the background, objectives of the study, and an overview of the protocol including design, organization and data collection methods. Methods/Design The study will recruit 230 community-dwelling participants diagnosed with Alzheimer's disease. Participants will be randomly allocated to two treatment groups: usual care group or 24-week home-based program consisting of 150 minutes per week of tailored moderate physical activity. The primary outcome measure of the study is cognitive decline as measured by the change from baseline in the total score on the Alzheimer's disease Assessment Scale-Cognitive section. Secondary outcomes of interest include behavioral and psychological symptoms, quality of life, functional level, carer burden and physical function (strength, balance, endurance, physical activity). Primary endpoints will be measured at six and twelve months following the baseline assessment. Discussion This RCT will contribute evidence regarding the potential benefits of a systematic program of physical activity as an affordable and safe intervention for people with Alzheimer's disease. Further, if successful, physical activity in combination with usual care has the potential to alleviate the symptoms of Alzheimer's disease and improve its management and the quality of life of patients and their carers. Trial Registration Australia New Zealand Clinical Trials Registry ACTRN12609000755235 PMID:21143943

  1. SAR image registration based on Susan algorithm

    NASA Astrophysics Data System (ADS)

    Wang, Chun-bo; Fu, Shao-hua; Wei, Zhong-yi

    2011-10-01

    Synthetic Aperture Radar (SAR) is an active remote sensing system which can be installed on aircraft, satellite and other carriers with the advantages of all day and night and all-weather ability. It is the important problem that how to deal with SAR and extract information reasonably and efficiently. Particularly SAR image geometric correction is the bottleneck to impede the application of SAR. In this paper we introduces image registration and the Susan algorithm knowledge firstly, then introduces the process of SAR image registration based on Susan algorithm and finally presents experimental results of SAR image registration. The Experiment shows that this method is effective and applicable, no matter from calculating the time or from the calculation accuracy.

  2. PROFESSIONAL REGISTRATION OF GOVERNMENT ENGINEERS.

    USGS Publications Warehouse

    Buchanan, Thomas J.

    1985-01-01

    The American Society of Civil Engineers views professional registration as an appropriate requirement for engineers, including those in government. The National Society of Professional Engineers makes registration a requirement for the grade of member and full privileges in the society. Some Federal agencies require engineering registration for certain positions in their agencies. Engineers in government service should consider the value of engineering registration to themselves and to their agencies and take pride in their professions and in their own capabilities by becoming registered engineers. They should also take steps to encourage their agencies to give more attention to engineering registration.

  3. Image registration with uncertainty analysis

    DOEpatents

    Simonson, Katherine M [Cedar Crest, NM

    2011-03-22

    In an image registration method, edges are detected in a first image and a second image. A percentage of edge pixels in a subset of the second image that are also edges in the first image shifted by a translation is calculated. A best registration point is calculated based on a maximum percentage of edges matched. In a predefined search region, all registration points other than the best registration point are identified that are not significantly worse than the best registration point according to a predetermined statistical criterion.

  4. Evaluating the effectiveness of psychosocial resilience training for heart health, and the added value of promoting physical activity: a cluster randomized trial of the READY program

    PubMed Central

    2009-01-01

    activity, and objective indicators of CHD risk (blood glucose, cholesterol [mmol·L-1], triglycerides, blood pressure). Process measures of attendance, engagement and fidelity will also be conducted. Linear analyses will be used to examine group differences in the outcome measures, and the product of coefficients method will be used to examine mediated effects. Discussion If successful, this program will provide an innovative means by which to promote psychosocial well-being for heart health in the general population. The program could also be adapted to promote well-being in other at risk population subgroups. Trial registration ACTRN12608000017325. PMID:19930615

  5. 75 FR 5077 - Pesticide Product; Registration Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ... AGENCY Pesticide Product; Registration Application AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has received an application to register a pesticide product containing an active... providing notice of receipt and opportunity to comment on this application. DATES: Comments must be...

  6. The Walking School Bus and Children's Physical Activity: A Pilot Cluster Randomized Controlled Trial

    PubMed Central

    Watson, Kathy; Baranowski, Tom; Nicklas, Theresa A.; Uscanga, Doris K.; Hanfling, Marcus J.

    2011-01-01

    OBJECTIVE: To evaluate the impact of a “walking school bus” program on children's rates of active commuting to school and physical activity. METHODS: We conducted a pilot cluster randomized controlled trial among 4th-graders from 8 schools in Houston, Texas (N = 149). Random allocation to treatment or control conditions was at the school level. Study staff walked with children to and from school up to 5 days/week. Outcomes were measured the week before (time 1) and during weeks 4 and 5 of the intervention (time 2). The main outcome was the weekly rate of active commuting, and a secondary outcome was moderate-to-vigorous physical activity. Covariates included sociodemographics, distance from home to school, neighborhood safety, child BMI z score, parent self-efficacy/outcome expectations, and child self-efficacy for active commuting. A mixed-model repeated measures regression accounted for clustering by school, and stepwise procedures with backward elimination of nonsignificant covariates were used to identify significant predictors. RESULTS: Intervention children increased active commuting (mean ± SD) from 23.8% ± 9.2% (time 1) to 54% ± 9.2% (time 2), whereas control subjects decreased from 40.2% ± 8.9% (time 1) to 32.6% ± 8.9% (time 2) (P < .0001). Intervention children increased their minutes of daily moderate-to-vigorous physical activity from 46.6 ± 4.5 (time 1) to 48.8 ± 4.5 (time 2), whereas control children decreased from 46.1 ± 4.3 (time 1) to 41.3 ± 4.3 (time 2) (P = .029). CONCLUSIONS: The program improved children's active commuting to school and daily moderate-to-vigorous physical activity. PMID:21859920

  7. Cardiovascular risk and mortality in end-stage renal disease patients undergoing dialysis: sleep study, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life: a prospective, double blind, randomized controlled clinical trial

    PubMed Central

    2013-01-01

    Background Chronic kidney disease (CKD) is one of the most serious public health problems. The increasing prevalence of CKD in developed and developing countries has led to a global epidemic. The hypothesis proposed is that patients undergoing dialysis would experience a marked negative influence on physiological variables of sleep and autonomic nervous system activity, compromising quality of life. Methods/Design A prospective, consecutive, double blind, randomized controlled clinical trial is proposed to address the effect of dialysis on sleep, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life in patients with CKD. The measurement protocol will include body weight (kg); height (cm); body mass index calculated as weight/height2; circumferences (cm) of the neck, waist, and hip; heart and respiratory rates; blood pressures; Mallampati index; tonsil index; heart rate variability; maximum ventilatory pressures; negative expiratory pressure test, and polysomnography (sleep study), as well as the administration of specific questionnaires addressing sleep apnea, excessive daytime sleepiness, depression, anxiety, stress, and quality of life. Discussion CKD is a major public health problem worldwide, and its incidence has increased in part by the increased life expectancy and increasing number of cases of diabetes mellitus and hypertension. Sleep disorders are common in patients with renal insufficiency. Our hypothesis is that the weather weight gain due to volume overload observed during interdialytic period will influence the degree of collapsibility of the upper airway due to narrowing and predispose to upper airway occlusion during sleep, and to investigate the negative influences of haemodialysis in the physiological variables of sleep, and autonomic nervous system, and respiratory mechanics and thereby compromise the quality of life of patients. Trial registration The

  8. Adjunctive Behavioral Activation for the Treatment of Bipolar Depression: A Proof of Concept Trial

    PubMed Central

    Weinstock, Lauren M.; Melvin, Caitlin; Munroe, Mary K.; Miller, Ivan W.

    2016-01-01

    Background Grounded in a model focused on exposure to response-contingent positive reinforcement, and with evidence supporting its acute treatment effects for unipolar depression, an adjunctive behavioral activation (BA) intervention may be especially well suited to the treatment of bipolar depression. The goal of this study was to modify BA for the adjunctive treatment of bipolar depression and to pilot it in a proof of concept trial to assess its preliminary feasibility and acceptability for this population. Methods Twelve adults with bipolar depression were recruited from hospital settings and enrolled in a 20-week open trial of the modified BA, delivered in 16 outpatient sessions, as an adjunct to community pharmacotherapy for bipolar disorder. Symptom severity was assessed at pre- and post-treatment by an independent evaluator. Patient satisfaction was also assessed post-treatment. Results Feasibility and acceptability were high, with 10 of 12 patients completing treatment, an average of 14.8 (SD = 5.2) of 16 sessions attended, and high levels of self-reported treatment satisfaction. Patients exhibited statistically significant improvement from pre- to post-treatment on measures of depressive symptoms, manic symptoms, and severity of suicidal ideation. Conclusions Although preliminary and requiring replication in a larger sample, these study data suggest that a modified BA intervention may offer promise as an adjunctive approach for the acute treatment of bipolar depression. Future studies that employ more rigorous randomized controlled designs and that directly assess potential mechanisms of action are recommended. PMID:27138086

  9. Increasing Recreational Physical Activity in Patients With Chronic Low Back Pain: A Pragmatic Controlled Clinical Trial.

    PubMed

    Ben-Ami, Noa; Chodick, Gabriel; Mirovsky, Yigal; Pincus, Tamar; Shapiro, Yair

    2017-02-01

    Study Design Prospective, pragmatic, nonrandomized controlled clinical trial. Background Clinical guidelines recommend physical activity for the treatment of chronic low back pain. But engaging patients in physical activity has proven difficult. Known obstacles to physical activity include low self-efficacy and fear avoidance. Objectives This study tested the effectiveness of an enhanced transtheoretical model intervention (ETMI) aimed at increasing recreational physical activity in patients with chronic low back pain, in comparison to usual physical therapy. Methods Patients (n = 220) referred to physical therapy for chronic low back pain were allocated to ETMI or to a control group. The ETMI was delivered by physical therapists and based on behavior-change principles, combined with increased reassurance, therapeutic alliance, and exposure to reduce fear avoidance. The primary outcome was back pain-related disability (Roland-Morris Disability Questionnaire). Secondary outcomes included pain intensity, mental and physical health, and levels of physical activity. Results Intention-to-treat analysis in 189 patients at 12 months indicated that patients in the ETMI group had significantly lower disability compared to usual physical therapy. The difference in mean change from baseline between the interventions was 2.7 points (95% confidence interval: 0.9, 4.5) on the Roland-Morris Disability Questionnaire. At 12 months, worst pain, physical activity, and physical health were all significantly better in patients receiving ETMI. The average number of sessions was 3.5 for the ETMI group and 5.1 for controls. Conclusion Targeting obstacles to physical activity with an intervention that includes components to address self-efficacy and fear avoidance appears to be more effective than usual physical therapy care in reducing long-term disability. Further research is needed to explore the mechanisms that impact outcomes in this intervention package. Level of Evidence Therapy

  10. Experience of the National Cancer Institute Community Cancer Centers Program on Community-Based Cancer Clinical Trials Activity

    PubMed Central

    Locke, Susan C.; Abernethy, Amy P.

    2016-01-01

    Purpose: A goal of the National Cancer Institute Community Cancer Centers Program (NCCCP) was to improve cancer research capacity in community settings. We examined research capacity development during the pilot phase of the NCCCP within the context of national trends in clinical trial activity with respect to the number and phase of trials, total accrual, and accrual of underserved populations. Materials and Methods: We examined self-reported data from NCCCP sites during 2007 to 2010, supplemented with data from the National Cancer Institute Cancer Therapy Evaluation Program. Results: Trial availability and accrual improved more quickly at NCCCP sites compared with national trends. Phase III trial availability increased 8% nationally versus 16% across NCCCP sites, and accrual increased 30% nationally versus 133% across NCCCP sites. Accrual of racial and ethnic minorities rose 82%, from 83 to 151 patients, and accrual of patients age ≥ 65 years rose by 221%, from 200 to 641 patients. Change in trial portfolio and accrual differed by sophistication of the site and by prior experience in conducting clinical trials at the site. Conclusion: Despite the short duration, the NCCCP pilot resulted in an increase in the number of open trials as well as patient accrual at a faster rate than that observed nationally. These results, coupled with insights into the relative success of sites with varying sophistication at the outset, provide promise that lessons learned can be applied more broadly to increase research participation. PMID:27026649

  11. Web-Based Video-Coaching to Assist an Automated Computer-Tailored Physical Activity Intervention for Inactive Adults: A Randomized Controlled Trial

    PubMed Central

    Jennings, Cally; Plotnikoff, Ronald C; Vandelanotte, Corneel

    2016-01-01

    modules vs 18/42, 43%, P=.01) and engagement (110 minutes spent on the website vs 78 minutes, P=.02) compared with other participants. There were no overall retention, adherence, engagement, and satisfaction differences between tailoring + video-coaching and tailoring-only participants. At 9 weeks, physical activity increased from baseline to postintervention in all groups (tailoring + video-coaching: +150 minutes/week; tailoring only: +123 minutes/week; waitlist control: +34 minutes/week). The increase was significantly higher in the tailoring + video-coaching group compared with the control group (P=.01). No significant difference was found between intervention groups and no significant between-group differences were found for physical activity change at 6 months. Conclusions Only small improvements were observed when video-coaching was added to computer-tailored advice in a Web-based physical activity intervention. However, combined Web-based video-coaching and computer-tailored advice was effective in comparison with a control group. More research is needed to determine whether Web-based coaching is more effective than stand-alone computer-tailored advice. Trial Registration Australian New Zealand Clinical Trials Registry (ACTRN): 12614000339651; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614000339651+&isBasic=True (Archived by WebCite at http://www.webcitation.org/6jTnOv0Ld) PMID:27520283

  12. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

  13. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

  14. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

  15. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

  16. Spacecraft camera image registration

    NASA Technical Reports Server (NTRS)

    Kamel, Ahmed A. (Inventor); Graul, Donald W. (Inventor); Chan, Fred N. T. (Inventor); Gamble, Donald W. (Inventor)

    1987-01-01

    A system for achieving spacecraft camera (1, 2) image registration comprises a portion external to the spacecraft and an image motion compensation system (IMCS) portion onboard the spacecraft. Within the IMCS, a computer (38) calculates an image registration compensation signal (60) which is sent to the scan control loops (84, 88, 94, 98) of the onboard cameras (1, 2). At the location external to the spacecraft, the long-term orbital and attitude perturbations on the spacecraft are modeled. Coefficients (K, A) from this model are periodically sent to the onboard computer (38) by means of a command unit (39). The coefficients (K, A) take into account observations of stars and landmarks made by the spacecraft cameras (1, 2) themselves. The computer (38) takes as inputs the updated coefficients (K, A) plus synchronization information indicating the mirror position (AZ, EL) of each of the spacecraft cameras (1, 2), operating mode, and starting and stopping status of the scan lines generated by these cameras (1, 2), and generates in response thereto the image registration compensation signal (60). The sources of periodic thermal errors on the spacecraft are discussed. The system is checked by calculating measurement residuals, the difference between the landmark and star locations predicted at the external location and the landmark and star locations as measured by the spacecraft cameras (1, 2).

  17. Evaluation of personalised, one-to-one interaction using Montessori-type activities as a treatment of challenging behaviours in people with dementia: the study protocol of a crossover trial

    PubMed Central

    2010-01-01

    Background The agitated behaviours that accompany dementia (e.g. pacing, aggression, calling out) are stressful to both nursing home residents and their carers and are difficult to treat. Behaviours stemming from pain, major depression or psychosis benefit from treatment with analgesics, antidepressants or antipsychotics. In other cases, psychotropic medications have limited efficacy but are used very widely. Therefore, increasingly more attention has been paid to nonpharmacological interventions which are associated with fewer risks. The aim of the current study is to test if personalised one-to-one interaction activities based on Montessori principles will reduce the frequency of behavioural symptoms of dementia significantly more than a relevant control condition. Methods/Design We will conduct a controlled trial with randomised cross-over between conditions. Persons with moderate to severe dementia and associated behavioural problems living in aged care facilities will be included in the study. Consented, willing participants will be assigned in random order to Montessori or control blocks for two weeks then switched to the other condition. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence. The control intervention consists of conversation or reading from and looking at pictures in a newspaper to control for non-specific benefits of one-to-one interaction. Presence of target behaviour will be noted as well as level of engagement and type of affect displayed. Secondary measures also include the Cohen-Mansfield Agitation Inventory and information on time and funds spend to prepare the activities. Discussion If our results show that use of Montessori activities is effective in treating challenging behaviours in

  18. Acute effects of massage or active exercise in relieving muscle soreness: randomized controlled trial.

    PubMed

    Andersen, Lars L; Jay, Kenneth; Andersen, Christoffer H; Jakobsen, Markus D; Sundstrup, Emil; Topp, Robert; Behm, David G

    2013-12-01

    Massage is commonly believed to be the best modality for relieving muscle soreness. However, actively warming up the muscles with exercise may be an effective alternative. The purpose of this study was to compare the acute effect of massage with active exercise for relieving muscle soreness. Twenty healthy female volunteers (mean age 32 years) participated in this examiner-blind randomized controlled trial (ClinicalTrials.gov NCT01478451). The participants performed eccentric contractions for the upper trapezius muscle on a Biodex dynamometer. Delayed onset muscle soreness (DOMS) presented 48 hours later, at which the participants (a) received 10 minutes of massage of the trapezius muscle or (b) performed 10 minutes of active exercise (shoulder shrugs 10 × 10 reps) with increasing elastic resistance (Thera-Band). First, 1 treatment was randomly applied to 1 shoulder while the contralateral shoulder served as a passive control. Two hours later, the contralateral resting shoulder received the other treatment. The participants rated the intensity of soreness (scale 0-10), and a blinded examiner took measures of pressure pain threshold (PPT) of the upper trapezius immediately before treatment and 0, 10, 20, and 60 minutes after treatment 48 hours posteccentric exercise. Immediately before treatment, the intensity of soreness was 5.0 (SD 2.2) and PPT was 138 (SD 78) kPa. In response to treatment, a significant treatment by time interaction was found for the intensity of soreness (p < 0.001) and PPT (p < 0.05). Compared with control, both active exercise and massage significantly reduced the intensity of soreness and increased PPT (i.e., reduced pain sensitivity). For both types of treatment, the greatest effect on perceived soreness occurred immediately after treatment, whereas the effect on PPT peaked 20 minutes after treatment. In conclusion, active exercise using elastic resistance provides similar acute relief of muscle soreness as compared with that using massage

  19. Long-term effects of the Active for Life Year 5 (AFLY5) school-based cluster-randomised controlled trial

    PubMed Central

    Anderson, Emma L; Howe, Laura D; Kipping, Ruth R; Campbell, Rona; Jago, Russell; Noble, Sian M; Wells, Sian; Chittleborough, Catherine; Peters, Tim J; Lawlor, Debbie A

    2016-01-01

    Objective To investigate the long-term effectiveness of a school-based intervention to improve physical activity and diet in children. Design Cluster-randomised controlled trial. Setting 60 primary schools in the southwest of England. Participants Primary school children who were aged 8–9 years at recruitment, 9–10 years during the intervention and 10–11 years at the long-term follow-up assessment. Intervention Teacher training, provision of lesson and child–parent interactive homework plans and teaching materials. Main outcome measures Primary outcomes were accelerometer-assessed minutes of moderate to vigorous physical activity (MVPA) per day, accelerometer-assessed minutes of sedentary behaviour per day and reported daily consumption of servings of fruit and vegetables. Results 60 schools with 2221 eligible children were recruited. As in the previously published assessment immediately after the end of the intervention, none of the three primary outcomes differed between children in schools allocated to the intervention, compared with those in control schools at the end of the long-term follow-up (1 year after the end of the intervention). Differences in secondary outcomes were consistent with those at the immediate follow-up, with no evidence that these had diminished over time. Comparing intervention with control schools, the difference in mean child-reported screen viewing at the weekend was −16.03 min (95% CI −32.82 to 0.73), for servings of snacks per day, the difference was −0.11 (95% CI −0.39 to 0.06), in servings of high-energy drinks per day −0.20 (95% CI −0.39 to −0.01) and in servings of high-fat foods per day −0.12 (95% CI −0.39 to 0.00). None of these reached our predefined level of statistical significance, especially after accounting for multiple testing. Conclusions School-based curriculum interventions alone are unlikely to have a major public health impact on children's diet and physical activity. Trial

  20. Do brief online planning interventions increase physical activity amongst university students? A randomised controlled trial.

    PubMed

    Skår, Silje; Sniehotta, Falko F; Molloy, Gerard J; Prestwich, Andrew; Araújo-Soares, Vera

    2011-04-01

    Brief planning interventions, usually delivered within paper and pencil questionnaires, have been found to be effective in changing health behaviours. Using a double-blind randomised controlled trial, this study examined the efficacy of two types of planning interventions (action plans and coping plans) in increasing physical activity levels when they are delivered via the internet. Following the completion of self-reported physical activity (primary outcome) and theory of planned behaviour (TPB) measures at baseline, students (N = 1273) were randomised into one of four conditions on the basis of a 2 (received instructions to form action plans or not) × 2 (received instructions to form coping plans or not) factorial design. Physical activity (primary outcome) and TPB measures were completed again at two-month follow-up. An objective measure (attendance at the university's sports facilities) was employed 6 weeks after a follow-up for a duration of 13 weeks (secondary outcome). The interventions did not change self-reported physical activity, attendance at campus sports facilities or TPB measures. This might be due to low adherence to the intervention protocol (ranging from 58.8 to 76.7%). The results of this study suggest that the planning interventions under investigation are ineffective in changing behaviour when delivered online to a sample of participants unaware of the allocation to different conditions. Possible moderators of the effectiveness of planning interventions in changing health behaviours are discussed.

  1. Enhancing physical activity adherence and well-being in multiple sclerosis: a randomised controlled trial.

    PubMed

    McAuley, E; Motl, R W; Morris, K S; Hu, L; Doerksen, S E; Elavsky, S; Konopack, J F

    2007-06-01

    Individuals with multiple sclerosis (MS) are more sedentary than the general population, increasing their propensity for reduced functional ability, mobility, and activities of daily living. Self-efficacy has been one of the most consistent determinants of physical activity across populations, including those with MS. However, no studies exist that have attempted to influence self-efficacy in MS patients, in an effort to improve physical activity participation. We conducted a three-month randomised, controlled trial (n=26), contrasting the effects of an efficacy-enhancement exercise condition and a control exercise condition on exercise adherence, well-being, and affective responses to exercise. Analyses indicated that individuals in the efficacy enhancement condition attended more exercise sessions, reported greater levels of well-being and exertion, and felt better following exercise than individuals in the standard care condition. Regardless of treatment condition, individuals with a stronger sense of exercise self-efficacy, who reported more enjoyment following the exercise sessions, demonstrated significantly greater adherence with the exercise program. We believe this to be the first empirical attempt to change physical activity behavior in persons with MS using a well-established theoretical framework to drive the intervention. Continued examination of self-efficacy as a determinant of behavior change in individuals with MS is needed.

  2. Associative learning over trials activates the hippocampus in healthy elderly but not mild cognitive impairment.

    PubMed

    Johnson, Sterling C; Schmitz, Taylor W; Asthana, Sanjay; Gluck, Mark A; Myers, Catherine

    2008-03-01

    The ability to form associations between choice alternatives and their contingent outcomes is an important aspect of learning that may be sensitive to hippocampal dysfunction in memory disorders of aging such as amnestic mild cognitive impairment (MCIa), or early Alzheimer disease. In this preliminary study we examined brain activation using functional magnetic resonance imaging (fMRI) in 12 healthy elderly participants and nine patients with MCIa during an associative learning task. Using a high-field 3.0-Tesla MRI scanner, we examined the dynamic neural response during associative learning over trials. The slope of signal attenuation associated with learning was analyzed for differences between groups within an a priori defined hippocampal region. Results indicated dynamic signal attenuation associated with learning in the healthy elderly sample, but not in MCIa. The absence of an associative learning effect in the MCIa sample reaffirms an important link between the learning difficulties that are commonly encountered in MCIa and the mesial temporal region.

  3. The HIKCUPS trial: a multi-site randomized controlled trial of a combined physical activity skill-development and dietary modification program in overweight and obese children

    PubMed Central

    Jones, Rachel A; Okely, Anthony D; Collins, Clare E; Morgan, Philip J; Steele, Julie R; Warren, Janet M; Baur, Louise A; Cliff, Dylan P; Burrows, Tracy; Cleary, Jane

    2007-01-01

    Background Childhood obesity is one of the most pressing health issues of our time. Key health organizations have recommended research be conducted on the effectiveness of well-designed interventions to combat childhood obesity that can be translated into a variety of settings. This paper describes the design and methods used in the Hunter Illawarra Kids Challenge Using Parent Support (HIKCUPS) trial, an ongoing multi-site randomized controlled trial, in overweight/obese children comparing the efficacy of three interventions: 1) a parent-centered dietary modification program; 2) a child-centered physical activity skill-development program; and 3) a program combining both 1 and 2 above. Methods/Design Each intervention consists of three components: i) 10-weekly face-to-face group sessions; ii) a weekly homework component, completed between each face-to-face session and iii) three telephone calls at monthly intervals following completion of the 10-week program. Details of the programs' methodological aspects of recruitment, randomization and statistical analyses are described here a priori. Discussion Importantly this paper describes how HIKCUPS addresses some of the short falls in the current literature pertaining to the efficacy of child obesity interventions. The HIKCUPS trial is funded by the National Medical Research Council, Australia. PMID:17263896

  4. Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial

    PubMed Central

    Tiedemann, Anne; Rissel, Chris; Howard, Kirsten; Tong, Allison; Merom, Dafna; Smith, Stuart; Wickham, James; Bauman, Adrian; Lord, Stephen R; Vogler, Constance; Lindley, Richard I; Simpson, Judy M; Allman-Farinelli, Margaret; Sherrington, Catherine

    2016-01-01

    Introduction Prevention of falls and promotion of physical activity are essential for maximising well-being in older age. However, there is evidence that promoting physical activity among older people without providing fall prevention advice may increase fall rates. This trial aims to establish the impact of a physical activity and fall prevention programme compared with a healthy eating programme on physical activity and falls among people aged 60+ years. Methods and analysis This cluster randomised controlled trial will involve 60 groups of community-dwelling people aged 60+ years. Participating groups will be randomised to: (1) a physical activity and fall prevention intervention (30 groups), involving written information, fall risk assessment and prevention advice, a pedometer-based physical activity tracker and telephone-based health coaching; or (2) a healthy eating intervention (30 groups) involving written information and telephone-based dietary coaching. Primary outcomes will be objectively measured physical activity at 12 months post-randomisation and self-reported falls throughout the 12-month trial period. Secondary outcomes include: the proportion of fallers, the proportion of people meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and health and community service use. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will be preplanned, conducted while masked to group allocation, will take into account cluster randomisation, and will use an intention-to-treat approach. Ethics and

  5. Controlled trial of a thymic hormone extract (Thymostimulin) in 'autoimmune' chronic active hepatitis.

    PubMed Central

    Hegarty, J E; Nouri Aria, K T; Eddleston, A L; Williams, R

    1984-01-01

    A randomised controlled trial of thymic hormone extracts (Thymostimulin) (1 mg/kg/day for seven days; 1 mg/kg/weekly thereafter) was undertaken in 30 patients (21 women, nine men) with treated, apparently inactive 'autoimmune' chronic active hepatitis during withdrawal of maintenance corticosteroid and azathioprine therapy. Reactivation of disease occurred in 26 patients (86%) during or after treatment withdrawal and was as frequent in the Thymostimulin treated (11 of 13; 84%) and untreated (15 of 17; 88%; p greater than 0.05) groups. Reactivation of disease was accompanied by a severe defect in concanavalin A induced suppressor cell activity, the magnitude of which was similar in the Thymostimulin treated and untreated groups (mean % suppression = 16.4 and 3.2 respectively; p greater than 0.05 vs 84.4 in control subjects). Further studies assessing the optimal dose, duration of treatment, and mode of administration are required to establish a therapeutic role for thymic hormone extracts in 'autoimmune' chronic active hepatitis. PMID:6230296

  6. Single-trial analysis of cortical oscillatory activities during voluntary movements using empirical mode decomposition (EMD)-based spatiotemporal approach.

    PubMed

    Lee, Po-Lei; Shang, Li-Zen; Wu, Yu-Te; Shu, Chih-Hung; Hsieh, Jen-Chuen; Lin, Yung-Yang; Wu, Chi-Hsun; Liu, Yu-Lu; Yang, Chia-Yen; Sun, Chia-Wei; Shyu, Kuo-Kai

    2009-08-01

    This study presents a method based on empirical mode decomposition (EMD) and a spatial template-based matching approach to extract sensorimotor oscillatory activities from multi-channel magnetoencephalographic (MEG) measurements during right index finger lifting. The longitudinal gradiometer of the sensor unit which presents most prominent SEF was selected on which each single-trial recording was decomposed into a set of intrinsic mode functions (IMFs). The correlation between each IMF of the selected channel and raw data on other channels were created and represented as a spatial map. The sensorimotor-related IMFs with corresponding correlational spatial map exhibiting large values on primary sensorimotor area (SMI) were selected via spatial-template matching process. Trial-specific alpha and beta bands were determined in sensorimotor-related oscillatory activities using a two-spectrum comparison between the spectra obtained from baseline period (-4 to -3 s) and movement-onset period (-0.5 to 0.5 s). Sensorimotor-related oscillatory activities were filtered within the trial-specific frequency bands to resolve task-related oscillatory activities. Results demonstrated that the optimal phase and amplitude information were preserved not only for alpha suppression (event-related desynchronization) and beta rebound (event-related synchronization) but also for profound analysis of subtle dynamics across trials. The retention of high SNR in the extracted oscillatory activities allow various methods of source estimation that can be applied to study the intricate brain dynamics of motor control mechanisms. The present study enables the possibility of investigating cortical pathophysiology of movement disorder on a trial-by-trial basis which also permits an effective alternative for participants or patients who can not endure lengthy procedures or are incapable of sustaining long experiments.

  7. Rationale and study protocol for the supporting children’s outcomes using rewards, exercise and skills (SCORES) group randomized controlled trial: A physical activity and fundamental movement skills intervention for primary schools in low-income communities

    PubMed Central

    2012-01-01

    Background Many Australian children are insufficiently active to accrue health benefits and physical activity (PA) levels are consistently lower among youth of low socio-economic position. PA levels decline dramatically during adolescence and evidence suggests that competency in a range of fundamental movement skills (FMS) may serve as a protective factor against this trend. Methods/design The Supporting Children’s Outcomes Using Rewards Exercise and Skills (SCORES) intervention is a multi-component PA and FMS intervention for primary schools in low-income communities, which will be evaluated using a group randomized controlled trial. The socio-ecological model provided a framework for the 12-month intervention, which includes the following components: teacher professional learning, student leadership workshops (including leadership accreditation and rewards, e.g., stickers, water bottles), PA policy review, PA equipment packs, parental engagement via newsletters, FMS homework and a parent evening, and community partnerships with local sporting organizations. Outcomes will be assessed at baseline, 6- and 12-months. The primary outcomes are PA (accelerometers), FMS (Test of Gross Motor Development II) and cardiorespiratory fitness (multi-stage fitness test). Secondary outcomes include body mass index [using weight (kg)/height (m2)], perceived competence, physical self-esteem, and resilience. Individual and environmental mediators of behavior change (e.g. social support and enjoyment) will also be assessed. The System for Observing Fitness Instruction Time will be used to assess the impact of the intervention on PA within physical education lessons. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA behavior change will be explored. Discussion SCORES is an innovative primary school-based PA and FMS intervention designed to support students attending schools in low-income communities to be more skilled and active. The

  8. NAP SACC UK: protocol for a feasibility cluster randomised controlled trial in nurseries and at home to increase physical activity and healthy eating in children aged 2–4 years

    PubMed Central

    Kipping, R; Jago, R; Metcalfe, C; White, J; Papadaki, A; Campbell, R; Hollingworth, W; Ward, D; Wells, S; Brockman, R; Nicholson, A; Moore, L

    2016-01-01

    Introduction Systematic reviews have identified the lack of intervention studies with young children to prevent obesity. This feasibility study examines the feasibility and acceptability of adapting the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) intervention in the UK to inform a full-scale trial. Methods and analysis A feasibility cluster randomised controlled trial in 12 nurseries in England, with 6 randomly assigned to the adapted NAP SACC UK intervention: nursery staff will receive training and support from an NAP SACC UK Partner to review the nursery environment (nutrition, physical activity, sedentary behaviours and oral health) and set goals for making changes. Parents will be invited to participate in a digital media-based home component to set goals for making changes in the home. As this is a feasibility study, the sample size was not based on a power calculation but will indicate the likely response rates and intracluster correlations. Measures will be assessed at baseline and 8–10 months later. We will estimate the recruitment rate of nurseries and children and adherence to the intervention and data. Nursery measurements will include the Environmental Policy Assessment and Observation score and the nursery staff's review of the nursery environment. Child measurements will include height and weight to calculate z-score body mass index (zBMI), accelerometer-determined minutes of moderate-to-vigorous physical activity per day and sedentary time, and diet using the Child and Diet Evaluation Tool. Questionnaires with nursery staff and parents will measure mediators. A process evaluation will assess fidelity of intervention delivery and views of participants. Ethics and dissemination Ethical approval for this study was given by Wales 3 NHS Research Ethics Committee. Findings will be made available through publication in peer-reviewed journals, at conferences and to participants via the University of Bristol website. Data

  9. Tritherapy (Spinalon)-Elicited Spinal Locomotor Network Activation: Phase I-IIa Clinical Trial in Spinal Cord-Injured Patients

    DTIC Science & Technology

    2013-10-01

    PROTOCOL SPIN-01 Tri- therapy (SPINALON)-elicited spinal locomotor network activation: Phase I-Ila clinicaltrials in spinalcord-injured patients Clinical...STUDY) described in the Protocol SPIN-01 (PROTOCOL) being entitled: "Tri- therapy (SPINALON)-elicited spinal locomotor network activation: Phase I...Report SC100155 SPIN-01 Tri- therapy (SPINALON)-elicited spinal locomotor network activation: Phase I-IIa clinical trials in spinal cord-injured

  10. Autophagy activation in COL6 myopathic patients by a low-protein-diet pilot trial

    PubMed Central

    Castagnaro, Silvia; Pellegrini, Camilla; Pellegrini, Massimo; Chrisam, Martina; Sabatelli, Patrizia; Toni, Silvia; Grumati, Paolo; Ripamonti, Claudio; Pratelli, Loredana; Maraldi, Nadir M.; Cocchi, Daniela; Righi, Valeria; Faldini, Cesare; Sandri, Marco; Bonaldo, Paolo; Merlini, Luciano

    2016-01-01

    ABSTRACT A pilot clinical trial based on nutritional modulation was designed to assess the efficacy of a one-year low-protein diet in activating autophagy in skeletal muscle of patients affected by COL6/collagen VI-related myopathies. Ullrich congenital muscular dystrophy and Bethlem myopathy are rare inherited muscle disorders caused by mutations of COL6 genes and for which no cure is yet available. Studies in col6 null mice revealed that myofiber degeneration involves autophagy defects and that forced activation of autophagy results in the amelioration of muscle pathology. Seven adult patients affected by COL6 myopathies underwent a controlled low-protein diet for 12 mo and we evaluated the presence of autophagosomes and the mRNA and protein levels for BECN1/Beclin 1 and MAP1LC3B/LC3B in muscle biopsies and blood leukocytes. Safety measures were assessed, including muscle strength, motor and respiratory function, and metabolic parameters. After one y of low-protein diet, autophagic markers were increased in skeletal muscle and blood leukocytes of patients. The treatment was safe as shown by preservation of lean:fat percentage of body composition, muscle strength and function. Moreover, the decreased incidence of myofiber apoptosis indicated benefits in muscle homeostasis, and the metabolic changes pointed at improved mitochondrial function. These data provide evidence that a low-protein diet is able to activate autophagy and is safe and tolerable in patients with COL6 myopathies, pointing at autophagy activation as a potential target for therapeutic applications. In addition, our findings indicate that blood leukocytes are a promising noninvasive tool for monitoring autophagy activation in patients. PMID:27656840

  11. Randomized controlled trial of physical activity, cognition, and walking in multiple sclerosis.

    PubMed

    Sandroff, Brian M; Klaren, Rachel E; Pilutti, Lara A; Dlugonski, Deirdre; Benedict, Ralph H B; Motl, Robert W

    2014-02-01

    The present study adopted a randomized controlled trial design and examined the effect of a physical activity behavioral intervention on cognitive and walking performance among persons with MS who have mild or moderate disability status. A total of 82 MS patients were randomly allocated into intervention or wait-list control conditions. The intervention condition received a theory-based program for increasing physical activity behavior that was delivered via the Internet, and one-on-one video chat sessions with a behavior-change coach. Participants completed self-report measures of physical activity and disability status, and underwent the oral Symbol Digit Modalities Test (SDMT) and 6-minute walk (6MW) test before and after the 6-month period. Analysis using mixed-model ANOVA indicated a significant time × condition × disability group interaction on SDMT scores (p = 0.02, partial-η (2) = 0.08), such that persons with mild disability in the intervention condition demonstrated a clinically meaningful improvement in SDMT scores (~6 point change). There was a further significant time × condition interaction on 6MW distance (p = 0.02, partial-η (2) = 0.07), such that those in the intervention condition demonstrated an increase in 6MW distance relative to those in the control group. The current study supports physical activity as a promising tool for managing cognitive impairment and impaired walking performance in persons with MS, and suggests that physical activity might have specific effects on cognition and non-specific effects on walking performance in this population.

  12. 40 CFR 162.152 - State registration authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... issue registrations to meet special local needs for the following types of new end-use products: (A) A... packaging, or in the identity of the formulator. (B) A product which contains the same active and...

  13. Efficacy of a Tobacco Quitline in Active Duty Military and TRICARE Beneficiaries: A Randomized Trial.

    PubMed

    Klesges, Robert C; Ebbert, Jon O; Talcott, G Wayne; Thomas, Fridtjof; Richey, Phyllis A; Womack, Catherine; Hryshko-Mullen, Ann; Oh, John

    2015-08-01

    A higher proportion of military personnel than civilians smoke cigarettes. Few randomized trials of tobacco use interventions have been conducted in the U.S. military. We evaluated the efficacy of a tobacco quitline (QL) in 1298 active duty military personnel, their dependents, reservists, and retirees who smoke cigarettes. Participants were randomized to either a proactive (counselor-initiated) or reactive (participant-initiated) QL intervention for 8 weeks. The proactive condition included up to an 8-week supply of free nicotine replacement therapy, and the reactive condition included a 2-week supply. The primary outcome was 12-month smoking abstinence. The enrolled population was predominantly affiliated with the Air Force and Army. At the end of treatment, proactive treatment was associated with a greater odds of both prolonged (44.22% vs. 24.96%; odds ratio [OR] = 2.4, P < 0.0001) and 7-day point prevalence (49.92% vs. 28.20%; OR = 2.5, P < 0.0001) smoking abstinence, a difference that was maintained for prolonged smoking abstinence at 12 months (22.03% vs. 13.41%; OR = 1.8, P < 0.0001). Our findings provide evidence that a proactive QL with nicotine replacement therapy is highly efficacious among Air Force and Army active duty and TRICARE beneficiaries and would provide an effective telephonic treatment option for this population of smokers.

  14. Physical activity, mindfulness meditation, or heart rate variability biofeedback for stress reduction: a randomized controlled trial.

    PubMed

    van der Zwan, Judith Esi; de Vente, Wieke; Huizink, Anja C; Bögels, Susan M; de Bruin, Esther I

    2015-12-01

    In contemporary western societies stress is highly prevalent, therefore the need for stress-reducing methods is great. This randomized controlled trial compared the efficacy of self-help physical activity (PA), mindfulness meditation (MM), and heart rate variability biofeedback (HRV-BF) in reducing stress and its related symptoms. We randomly allocated 126 participants to PA, MM, or HRV-BF upon enrollment, of whom 76 agreed to participate. The interventions consisted of psycho-education and an introduction to the specific intervention techniques and 5 weeks of daily exercises at home. The PA exercises consisted of a vigorous-intensity activity of free choice. The MM exercises consisted of guided mindfulness meditation. The HRV-BF exercises consisted of slow breathing with a heart rate variability biofeedback device. Participants received daily reminders for their exercises and were contacted weekly to monitor their progress. They completed questionnaires prior to, directly after, and 6 weeks after the intervention. Results indicated an overall beneficial effect consisting of reduced stress, anxiety and depressive symptoms, and improved psychological well-being and sleep quality. No significant between-intervention effect was found, suggesting that PA, MM, and HRV-BF are equally effective in reducing stress and its related symptoms. These self-help interventions provide easily accessible help for people with stress complaints.

  15. 17 CFR 250.1 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Registration. 250.1 Section... AND REGULATIONS, PUBLIC UTILITY HOLDING COMPANY ACT OF 1935 Registration and General Exemptions § 250.1 Registration. (a) Notification of registration. Notifications of registration pursuant to...

  16. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. Link to an amendment published... registration of an aircraft is invalid if, at the time it is made— (1) The aircraft is registered in a...

  17. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. Link to an amendment published... registration of an aircraft is invalid if, at the time it is made— (1) The aircraft is registered in a...

  18. 17 CFR 250.1 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Registration. 250.1 Section... AND REGULATIONS, PUBLIC UTILITY HOLDING COMPANY ACT OF 1935 Registration and General Exemptions § 250.1 Registration. (a) Notification of registration. Notifications of registration pursuant to...

  19. [Multinational clinical trial in Japan and Korea on detrusitol].

    PubMed

    Yoshinaga, Yukio

    2009-02-01

    A randomized, double-blind, placebo- and active comparator-controlled study was conducted in 69 centers to compare detrusitol and oxybutynin with placebo in Japanese and Korean patients with an overactive bladder (OAB). Detrusitol had similar efficacy but was better tolerated than oxybutynin in Japanese and Korean patients with OAB. The study result was acknowledged as pivotal data in the clinical data package when NDA was filed and successfully approved both in Japan and Korea. Some differences were found in the efficacy and safety of the drug between the Japanese and Korean data, though. We therefore investigated the differences through stratified analysis; however exact causes could not be identified. This study is positioned as a first multinational clinical trial conducted in East Asia. From the aspects of utilization of interoperable data obtained from such multinational clinical trials for NDA filing and earliest possible registration of drugs in the participating countries, we believe it is important to accumulate more experiences in conducting multinational clinical trials. At this time, it is our prime task to minimize the "drug lag" in Japan; I think improving the speed of clinical trials is one of the factors to solve the issue. Global clinical trials involving Western and Asian countries make it possible to use the study data effectively and commonly in many countries. Moreover, from the viewpoint of revitalization of clinical trials, conducting global clinical trials is critically important; so we intend to continue accumulation of our experiences in global clinical trials.

  20. Feasibility of Conducting a Randomized Trial to Promote Healthy Eating, Active Play and Sustainability Awareness in Early Childhood Curricula

    ERIC Educational Resources Information Center

    Morris, Heather; Skouteris, Helen; Edwards, Susan; Rutherford, Leonie Margaret; Cutter-Mackenzie, Amy; O'Connor, Amanda; Mantilla, Ana; Huang, Terry TK; Lording, Kate Marion; Williams-Smith, Janet

    2016-01-01

    We sought to evaluate the feasibility of conducting a randomized trial to evaluate the efficacy of a preschool/kindergarten curriculum intervention designed to increase 4-year-old children's knowledge of healthy eating, active play and the sustainability consequences of their food and toy choices. Ninety intervention and 65 control parent/child…

  1. Randomized Trial of Behavioral Activation, Cognitive Therapy, and Antidepressant Medication in the Prevention of Relapse and Recurrence in Major Depression

    ERIC Educational Resources Information Center

    Dobson, Keith S.; Hollon, Steven D.; Dimidjian, Sona; Schmaling, Karen B.; Kohlenberg, Robert J.; Gallop, Robert J.; Rizvi, Shireen L.; Gollan, Jackie K.; Dunner, David L.; Jacobson, Neil S.

    2008-01-01

    This study followed treatment responders from a randomized controlled trial of adults with major depression. Patients treated with medication but withdrawn onto pill-placebo had more relapse through 1 year of follow-up compared to patients who received prior behavioral activation, prior cognitive therapy, or continued medication. Prior…

  2. [Effect of short term graded physical exercise on the level of glycemia in children and adolescents with type 1 diabetes mellitus: data of long term ECG monitoring and registration of motor activity].

    PubMed

    Laptev, D N; Kruzhkova, M N; Riabykina, G V; Poliakov, S D; Korneeva, I T

    2012-01-01

    Study aim was to elucidate effect of graded physical exercise on glycemia level and interval QT duration in children and adolescents with type 1 diabetes mellitus. We carried out 25-hours parallel monitoring of glycemia, ECG and physical activity in 15 children and adolescents aged 9-17 years. During monitoring these patients performed an exercise test (PWC170). We found that there were two periods of significant and prolonged lowering of glycemia: in 120-420 min and 19-21 hours after exercise. Lowering of glycemia after physical exercise was associated with prolongation of QT interval. Registration of motor activity allowed to exclude changes of glycemia due to physical activity unrelated to graded exercise.

  3. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Drugs Intended... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and...

  4. fMRI single trial discovery of spatio-temporal brain activity patterns.

    PubMed

    Allegra, Michele; Seyed-Allaei, Shima; Pizzagalli, Fabrizio; Baftizadeh, Fahimeh; Maieron, Marta; Reverberi, Carlo; Laio, Alessandro; Amati, Daniele

    2017-03-01

    There is growing interest in the description of short-lived patterns in the spatiotemporal cortical activity monitored via neuroimaging. Most traditional analysis methods, designed to estimate relatively long-term brain dynamics, are not always appropriate to capture these patterns. Here we introduce a novel data-driven approach for detecting short-lived fMRI brain activity patterns. Exploiting Density Peak Clustering (Rodriguez and Laio [2014]), our approach reveals well localized clusters by identifying and grouping together voxels whose time-series are similar, irrespective of their brain location, even when very short time windows (∼10 volumes) are used. The method, which we call Coherence Density Peak Clustering (CDPC), is first tested on simulated data and compared with a standard unsupervised approach for fMRI analysis, independent component analysis (ICA). CDPC identifies activated voxels with essentially no false-positives and proves more reliable than ICA, which is troubled by a number of false positives comparable to that of true positives. The reliability of the method is demonstrated on real fMRI data from a simple motor task, containing brief iterations of the same movement. The clusters identified are found in regions expected to be involved in the task, and repeat synchronously with the paradigm. The methodology proposed is especially suitable for the study of short-time brain dynamics and single trial experiments, where the event or task of interest cannot be repeated for the same subject, as happens, for instance, in problem-solving, learning and decision-making. A GUI implementation of our method is available for download at https://github.com/micheleallegra/CDPC. Hum Brain Mapp 38:1421-1437, 2017. © 2016 Wiley Periodicals, Inc.

  5. A written self-help intervention for depressed adults comparing behavioural activation combined with physical activity promotion with a self-help intervention based upon behavioural activation alone: study protocol for a parallel group pilot randomised controlled trial (BAcPAc)

    PubMed Central

    2014-01-01

    Background Challenges remain to find ways to support patients with depression who have low levels of physical activity (PA) to overcome perceived barriers and enhance the perceived value of PA for preventing future relapse. There is an evidence-base for behavioural activation (BA) for depression, which focuses on supporting patients to restore activities that have been avoided, but practitioners have no specific training in promoting PA. We aimed to design and evaluate an integrated BA and PA (BAcPAc) practitioner-led, written, self-help intervention to enhance both physical and mental health. Methods/design This study is informed by the Medical Research Council Complex Intervention Framework and describes a protocol for a pilot phase II randomised controlled trial (RCT) to test the feasibility and acceptability of the trial methods to inform a definitive phase III RCT. Following development of the augmented written self-help intervention (BAcPAc) incorporating behavioural activation with physical activity promotion, depressed adults are randomised to receive up to 12 sessions over a maximum of 4 months of either BAcPAc or behavioural activation alone within a written self-help format, which represents treatment as usual. The study is located within two ‘Improving Access to Psychological Therapies’ services in South West England, with both written self-help interventions supported by mental health paraprofessionals. Measures assessed at 4, 9, and 12 month follow-up include the following: CIS-R, PHQ-9, accelerometer recorded (4 months only) and self-reported PA, body mass index, blood pressure, Insomnia Severity Index, quality of life, and health and social care service use. Process evaluation will include analysis of recorded support sessions and patient and practitioner interviews. At the time of writing the study has recruited 60 patients. Discussion The feasibility outcomes will inform a definitive RCT to assess the clinical and cost-effectiveness of the

  6. Improving diet, activity and wellness in adults at risk of diabetes: randomized controlled trial

    PubMed Central

    Block, G; Azar, K M J; Romanelli, R J; Block, T J; Palaniappan, L P; Dolginsky, M; Block, C H

    2016-01-01

    Objective: The purpose of this analysis is to examine the effect of an algorithm-driven online diabetes prevention program on changes in eating habits, physical activity and wellness/productivity factors. Methods: The intervention, Alive-PD, used small-step individually tailored goal setting and other features to promote changes in diet and physical activity. A 6-month randomized controlled trial was conducted among patients from a healthcare delivery system who had confirmed prediabetes (n =339). Change in weight and glycemic markers were measured in the clinic. Changes in physical activity, diet and wellness/productivity factors were self-reported. Mean age was 55 (s.d. 8.9) years, mean body mass index was 31 (s.d. 4.4) kg m−2, 68% were white and 69% were male. Results: The intervention group increased fruit/vegetable consumption by 3.71 (95% confidence interval (CI) 2.73, 4.70) times per week (effect size 0.62), and decreased refined carbohydrates by 3.77 (95% CI 3.10, 4.44) times per week both significantly (P<0.001) greater changes than in the control group. The intervention group also reported a significantly greater increase in physical activity than in the control group, effect size 0.49, P<0.001. In addition, the intervention group reported a significant increase in self-rated health, in confidence in ability to make dietary changes and in ability to accomplish tasks, and a decrease in fatigue, compared with the control group. These changes paralleled the significant treatment effects on glycemic markers and weight. Conclusions: In addition to promoting improvements in weight and glycemic markers, the Alive-PD program appears to improve eating habits and physical activity, behaviors important not just for diabetes prevention but for those with diagnosed diabetes or obesity. The improvements in wellness/productivity may derive from the diet and activity improvements, and from the satisfaction and self-efficacy of achieving goals. PMID:27643726

  7. Effectiveness of a Web-Based Physical Activity Intervention in Patients With Knee and/or Hip Osteoarthritis: Randomized Controlled Trial

    PubMed Central

    Veenhof, Cindy; Van Beek, Karin EC; Spreeuwenberg, Peter MM; Dekker, Joost; De Bakker, Dinny H

    2013-01-01

    Background Patients with knee and/or hip osteoarthritis (OA) are less physically active than the general population, while the benefits of physical activity (PA) have been well documented. Based on the behavioral graded activity treatment, we developed a Web-based intervention to improve PA levels in patients with knee and/or hip OA, entitled “Join2move”. The Join2move intervention is a self-paced 9-week PA program in which the patient’s favorite recreational activity is gradually increased in a time-contingent way. Objective The aim of the study was to investigate whether a fully automated Web-based PA intervention in patients with knee and/or hip OA would result in improved levels of PA, physical function, and self-perceived effect compared with a waiting list control group. Methods The study design was a two-armed randomized controlled trial which was not blinded. Volunteers were recruited via articles in newspapers and health-related websites. Eligibility criteria for participants were: (1) aged 50-75 years, (2) self-reported knee and/or hip OA, (3) self-reported inactivity (30 minutes of moderate PA, 5 times or less per week), (4) no face-to-face consultation with a health care provider other than general practitioners, for OA in the last 6 months, (5) ability to access the Internet weekly, and (6) no contra-indications to exercise without supervision. Baseline, 3-month, and 12-month follow-up data were collected through online questionnaires. Primary outcomes were PA, physical function, and self-perceived effect. In a subgroup of participants, PA was measured objectively using accelerometers. Secondary outcomes were pain, fatigue, anxiety, depression, symptoms, quality of life, self-efficacy, pain coping, and locus of control. Results Of the 581 interested respondents, 199 eligible participants were randomly assigned to the intervention (n=100) or waiting list control group (n=99). Response rates of questionnaires were 84.4% (168/199) after 3 months and

  8. Quantitative evaluation of registration methods for atlas-based diffuse optical tomography

    NASA Astrophysics Data System (ADS)

    Wu, Xue; Eggebrecht, Adam T.; Culver, Joseph P.; Zhan, Yuxuan; Basevi, Hector; Dehghani, Hamid

    2013-06-01

    In Diffuse Optical Tomography (DOT), an atlas-based model can be used as an alternative to a subject-specific anatomical model for recovery of brain activity. The main step of the generation of atlas-based subject model is the registration of atlas model to the subject head. The accuracy of the DOT then relies on the accuracy of registration method. In this work, 11 registration methods are quantitatively evaluated. The registration method with EEG 10/20 systems with 19 landmarks and non-iterative point to point algorithm provides approximately 1.4 mm surface error and is considered as the most efficient registration method.

  9. 75 FR 23759 - Pesticide Products; Registration Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... AGENCY Pesticide Products; Registration Applications AGENCY: Environmental Protection Agency (EPA... Hill, Registration Division (7504P), Office of Pesticide Programs, Environmental Protection Agency... deadline identified. II. Registration Applications EPA has received applications to register...

  10. 21 CFR 1301.13 - Application for registration; time for application; expiration date; registration for independent...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the form of a personal, certified, or cashier's check or money order made payable to the “Drug... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Application for registration; time for application...; coincident activities. 1301.13 Section 1301.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT...

  11. 21 CFR 1301.13 - Application for registration; time for application; expiration date; registration for independent...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the form of a personal, certified, or cashier's check or money order made payable to the “Drug... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Application for registration; time for application...; coincident activities. 1301.13 Section 1301.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT...

  12. 21 CFR 1301.13 - Application for registration; time for application; expiration date; registration for independent...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the form of a personal, certified, or cashier's check or money order made payable to the “Drug... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Application for registration; time for application...; coincident activities. 1301.13 Section 1301.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT...

  13. 21 CFR 1301.13 - Application for registration; time for application; expiration date; registration for independent...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the form of a personal, certified, or cashier's check or money order made payable to the “Drug... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Application for registration; time for application...; coincident activities. 1301.13 Section 1301.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT...

  14. 21 CFR 1301.13 - Application for registration; time for application; expiration date; registration for independent...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the form of a personal, certified, or cashier's check or money order made payable to the “Drug... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Application for registration; time for application...; coincident activities. 1301.13 Section 1301.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT...

  15. Antimicrobial activity of a quaternary ammonium methacryloxy silicate-containing acrylic resin: a randomised clinical trial

    PubMed Central

    Liu, Si-ying; Tonggu, Lige; Niu, Li-na; Gong, Shi-qiang; Fan, Bing; Wang, Liguo; Zhao, Ji-hong; Huang, Cui; Pashley, David H.; Tay, Franklin R.

    2016-01-01

    Quaternary ammonium methacryloxy silicate (QAMS)-containing acrylic resin demonstrated contact-killing antimicrobial ability in vitro after three months of water storage. The objective of the present double-blind randomised clinical trial was to determine the in vivo antimicrobial efficacy of QAMS-containing orthodontic acrylic by using custom-made removable retainers that were worn intraorally by 32 human subjects to create 48-hour multi-species plaque biofilms, using a split-mouth study design. Two control QAMS-free acrylic disks were inserted into the wells on one side of an orthodontic retainer, and two experimental QAMS-containing acrylic disks were inserted into the wells on the other side of the same retainer. After 48 hours, the disks were retrieved and examined for microbial vitality using confocal laser scanning microscopy. No harm to the oral mucosa or systemic health occurred. In the absence of carry-across effect and allocation bias (disks inserted in the left or right side of retainer), significant difference was identified between the percentage kill in the biovolume of QAMS-free control disks (3.73 ± 2.11%) and QAMS-containing experimental disks (33.94 ± 23.88%) retrieved from the subjects (P ≤ 0.001). The results validated that the QAMS-containing acrylic exhibits favourable antimicrobial activity against plaque biofilms in vivo. The QAMS-containing acrylic may also be used for fabricating removable acrylic dentures. PMID:26903314

  16. Pulsed electromagnetic fields on postmenopausal osteoporosis in Southwest China: a randomized, active-controlled clinical trial.

    PubMed

    Liu, Hui-Fang; Yang, Lin; He, Hong-Chen; Zhou, Jun; Liu, Ying; Wang, Chun-Yan; Wu, Yuan-Chao; He, Cheng-Qi

    2013-05-01

    A randomized, active-controlled clinical trial was conducted to examine the effect of pulsed electromagnetic fields (PEMFs) on women with postmenopausal osteoporosis (PMO) in southwest China. Forty-four participants were randomly assigned to receive alendronate or one course of PEMFs treatment. The primary endpoint was the mean percentage change in bone mineral density of the lumbar spine (BMDL), and secondary endpoints were the mean percentage changes in left proximal femur bone mineral density (BMDF), serum 25OH vitamin D3 (25(OH)D) concentrations, total lower-extremity manual muscle test (LE MMT) score, and Berg Balance Scale (BBS) score. The BMDL, BMDF, total LE MMT score and BBS score were recorded at baseline, 5, 12, and 24 weeks. Serum concentrations of 25(OH)D were measured at baseline and 5 weeks. Using a mixed linear model, there was no significant treatment difference between the two groups in the BMDL, BMDF, total LE MMT score, and BBS score (P ≥ 0.05). For 25(OH)D concentrations, the effects were also comparable between the two groups (P ≥ 0.05) with the Mann-Whitney's U-test. These results suggested that a course of PEMFs treatment with specific parameters was as effective as alendronate in treating PMO within 24 weeks.

  17. Moderators of Theory-Based Interventions to Promote Physical Activity in 77 Randomized Controlled Trials.

    PubMed

    Bernard, Paquito; Carayol, Marion; Gourlan, Mathieu; Boiché, Julie; Romain, Ahmed Jérôme; Bortolon, Catherine; Lareyre, Olivier; Ninot, Gregory

    2017-04-01

    A meta-analysis of randomized controlled trials (RCTs) has recently showed that theory-based interventions designed to promote physical activity (PA) significantly increased PA behavior. The objective of the present study was to investigate the moderators of the efficacy of these theory-based interventions. Seventy-seven RCTs evaluating theory-based interventions were systematically identified. Sample, intervention, methodology, and theory implementation characteristics were extracted, coded by three duos of independent investigators, and tested as moderators of interventions effect in a multiple-meta-regression model. Three moderators were negatively associated with the efficacy of theory-based interventions on PA behavior: intervention length (≥14 weeks; β = -.22, p = .004), number of experimental patients (β = -.10, p = .002), and global methodological quality score (β = -.08, p = .04). Our findings suggest that the efficacy of theory-based interventions to promote PA could be overestimated consequently due to methodological weaknesses of RCTs and that interventions shorter than 14 weeks could maximize the increase of PA behavior.

  18. Automatic registration of satellite imagery

    NASA Technical Reports Server (NTRS)

    Fonseca, Leila M. G.; Costa, Max H. M.; Manjunath, B. S.; Kenney, C.

    1997-01-01

    Image registration is one of the basic image processing operations in remote sensing. With the increase in the number of images collected every day from different sensors, automated registration of multi-sensor/multi-spectral images has become an important issue. A wide range of registration techniques has been developed for many different types of applications and data. The objective of this paper is to present an automatic registration algorithm which uses a multiresolution analysis procedure based upon the wavelet transform. The procedure is completely automatic and relies on the grey level information content of the images and their local wavelet transform modulus maxima. The registration algorithm is very simple and easy to apply because it needs basically one parameter. We have obtained very encouraging results on test data sets from the TM and SPOT sensor images of forest, urban and agricultural areas.

  19. Behavioral Weight Loss and Physical Activity Intervention in Obese Adults with Asthma. A Randomized Trial

    PubMed Central

    Strub, Peg; Xiao, Lan; Lavori, Philip W.; Camargo, Carlos A.; Wilson, Sandra R.; Gardner, Christopher D.; Buist, A. Sonia; Haskell, William L.; Lv, Nan

    2015-01-01

    Rationale: The effect of weight loss on asthma in obese adults warrants rigorous investigation. Objectives: To examine an evidence-based, practical, and comprehensive lifestyle intervention targeting modest weight loss and increased physical activity for asthma control. Methods: The trial randomized 330 obese adults with uncontrolled asthma to receive usual care enhanced with a pedometer, a weight scale, information about existing weight management services at the participating clinics, and an asthma education DVD, or with these tools plus the 12-month intervention. Measurements and Main Results: The primary outcome was change in Asthma Control Questionnaire (ACQ) scores from baseline to 12 months. Participants (mean [SD] age, 47.6 [12.4] yr) were 70.6% women, 20.0% non-Hispanic black, 20.3% Hispanic/Latino, and 8.2% Asian/Pacific Islander. At baseline, they were obese (mean [SD] body mass index, 37.5 [5.9] kg/m2) and had uncontrolled asthma (Asthma Control Test score, 15.1 [3.8]). Compared with control subjects, intervention participants achieved significantly greater mean weight loss (±SE) (intervention, −4.0 ± 0.8 kg vs. control, −2.1 ± 0.8 kg; P = 0.01) and increased leisure-time activity (intervention, 418.2 ± 110.6 metabolic equivalent task–min/wk vs. control, 178.8 ± 109.1 metabolic equivalent task–min/wk; P = 0.05) at 12 months. But between-treatment mean (±SE) differences were not significant for ACQ changes (intervention, –0.3 ± 0.1 vs. control, –0.2 ± 0.1; P = 0.92) from baseline (mean [SD], 1.4 [0.8]), nor for any other clinical asthma outcomes (e.g., spirometric results and asthma exacerbations). Among all participants regardless of treatment assignment, weight loss of 10% or greater was associated with a Cohen d effect of 0.76 and with 3.78 (95% confidence interval, 1.72–8.31) times the odds of achieving clinically significant reductions (i.e., ≥0.5) on ACQ as stable weight (<3% loss or gain from

  20. Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial

    PubMed Central

    Michaelson, Peter; Gard, Gunvor; Eriksson, Margareta K

    2016-01-01

    Background Web-based interventions with a focus on behavior change have been used for pain management, but studies of Web-based interventions integrated in clinical practice are lacking. To emphasize the development of cognitive skills and behavior, and to increase activity and self-care in rehabilitation, the Web Behavior Change Program for Activity (Web-BCPA) was developed and added to multimodal pain rehabilitation (MMR). Objective The objective of our study was to evaluate the effects of MMR in combination with the Web-BCPA compared with MMR among persons with persistent musculoskeletal pain in primary health care on pain intensity, self-efficacy, and copying, as part of a larger collection of data. Web-BCPA adherence and feasibility, as well as treatment satisfaction, were also investigated. Methods A total of 109 participants, mean age 43 (SD 11) years, with persistent pain in the back, neck, shoulder, and/or generalized pain were recruited to a randomized controlled trial with two intervention arms: (1) MMR+WEB (n=60) and (2) MMR (n=49). Participants in the MMR+WEB group self-guided through the eight modules of the Web-BCPA: pain, activity, behavior, stress and thoughts, sleep and negative thoughts, communication and self-esteem, solutions, and maintenance and progress. Data were collected with a questionnaire at baseline and at 4 and 12 months. Outcome measures were pain intensity (Visual Analog Scale), self-efficacy to control pain and to control other symptoms (Arthritis Self-Efficacy Scale), general self-efficacy (General Self-Efficacy Scale), and coping (two-item Coping Strategies Questionnaire; CSQ). Web-BCPA adherence was measured as minutes spent in the program. Satisfaction and Web-BCPA feasibility were assessed by a set of items. Results Of 109 participants, 99 received the allocated intervention (MMR+WEB: n=55; MMR: n=44); 88 of 99 (82%) completed the baseline and follow-up questionnaires. Intention-to-treat analyses were performed with a sample

  1. Support or competition? How online social networks increase physical activity: A randomized controlled trial.

    PubMed

    Zhang, Jingwen; Brackbill, Devon; Yang, Sijia; Becker, Joshua; Herbert, Natalie; Centola, Damon

    2016-12-01

    To identify what features of online social networks can increase physical activity, we conducted a 4-arm randomized controlled trial in 2014 in Philadelphia, PA. Students (n = 790, mean age = 25.2) at an university were randomly assigned to one of four conditions composed of either supportive or competitive relationships and either with individual or team incentives for attending exercise classes. The social comparison condition placed participants into 6-person competitive networks with individual incentives. The social support condition placed participants into 6-person teams with team incentives. The combined condition with both supportive and competitive relationships placed participants into 6-person teams, where participants could compare their team's performance to 5 other teams' performances. The control condition only allowed participants to attend classes with individual incentives. Rewards were based on the total number of classes attended by an individual, or the average number of classes attended by the members of a team. The outcome was the number of classes that participants attended. Data were analyzed using multilevel models in 2014. The mean attendance numbers per week were 35.7, 38.5, 20.3, and 16.8 in the social comparison, the combined, the control, and the social support conditions. Attendance numbers were 90% higher in the social comparison and the combined conditions (mean = 1.9, SE = 0.2) in contrast to the two conditions without comparison (mean = 1.0, SE = 0.2) (p = 0.003). Social comparison was more effective for increasing physical activity than social support and its effects did not depend on individual or team incentives.

  2. Very High Concentrations of Active Intracellular Phosphorylated Emtricitabine in Neonates (ANRS 12109 Trial, Step 2)▿

    PubMed Central

    Hirt, Déborah; Pruvost, Alain; Ekouévi, Didier K.; Urien, Saïk; Arrivé, Elise; Kone, Mamourou; Nerrienet, Eric; Nyati, Mandisa; Gray, Glenda; Kruy, Leang Sim; Blanche, Stéphane; Dabis, François; Tréluyer, Jean-Marc

    2011-01-01

    Our objective was to investigate neonatal emtricitabine (FTC) plasma and intracellular pharmacokinetics. The study was designed as a phase I/II prospective trial in two sequential steps evaluating the combination of tenofovir disoproxil fumarate (TDF) and FTC for the prevention of mother-to-child-transmission (PMTCT) of HIV. HIV-1-infected pregnant women received two tablets of TDF (300 mg) and FTC (200 mg) at onset of labor and then one tablet daily for 7 days postpartum. Based on the data obtained in the first part of the Tenofovir/Emtricitabine in Africa and Asia (TEmAA) Study, single doses of 2 mg/kg of FTC and 13 mg/kg of TDF were given to the neonates within 12 h after birth. A total of 540 FTC plasma concentrations and 44 active intracellular phosphorylated metabolite FTC-TP concentrations were taken from the 36 enrolled women and their neonates. Concentrations were measured by the liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and analyzed by a population approach. The proposed dose obtained by simulations based on plasma drug concentrations was confirmed. However, median FTC-TP exposures were, respectively, 5.9 and 6.8 times higher in the fetus and the neonate than in the adult. High FTC-TP concentrations were observed in the four children who had serious adverse events (SAEs), but the link between FTC-TP concentrations and SAEs in children was not formally identified. The exposure to the active form of FTC was high in neonates despite plasma drug concentrations equivalent to those in adults. Our results are similar to those obtained with zidovudine or lamivudine. PMID:21464241

  3. Image registration method for medical image sequences

    DOEpatents

    Gee, Timothy F.; Goddard, James S.

    2013-03-26

    Image registration of low contrast image sequences is provided. In one aspect, a desired region of an image is automatically segmented and only the desired region is registered. Active contours and adaptive thresholding of intensity or edge information may be used to segment the desired regions. A transform function is defined to register the segmented region, and sub-pixel information may be determined using one or more interpolation methods.

  4. Physical Activity and Lymphedema (The PAL Trial): Assessing the safety of progressive strength training in breast cancer survivors

    PubMed Central

    Schmitz, Kathryn H.; Troxel, Andrea B.; Cheville, Andrea; Grant, Lorita L.; Bryan, Cathy J.; Gross, Cynthia; Lytle, Leslie A.; Ahmed, Rehana L.

    2009-01-01

    Lymphedema is a chronic and progressive long-term adverse effect of breast cancer treatment commonly defined by swelling of the affected arm. Current clinical guidelines indicate that women with and at risk for lymphedema should protect the affected arm from overuse. In clinical practice, this often translates into risk aversive guidance to avoid using the arm. This could lead to a disuse pattern that may increase the likelihood of injury from common activities of daily living. Further, such guidance poses an additional barrier to staying physically active, potentially translating to weight gain, which has been shown to be associated with worse clinical course for women with lymphedema. We hypothesize that a program of slowly progressive strength training with no upper limit on the amount of weight that may be lifted would gradually increase the physiologic capacity of the arm so that common activities represent a decreasing percentage of maximal capacity. Theoretically, this increased capacity should decrease the risk that daily activities put stress on the lymphatic system of the affected side. The Physical Activity and Lymphedema (PAL) Trial is a recently completed randomized controlled exercise intervention trial that recruited 295 breast cancer survivors (141 with lymphedema at study entry, 154 at risk for lymphedema at study entry). The purpose of this report is to provide detail regarding the study design, statistical design, and protocol of the PAL trial. PMID:19171204

  5. Functional changes in adipose tissue in a randomised controlled trial of physical activity

    PubMed Central

    2012-01-01

    Background A sedentary lifestyle predisposes to cardiometabolic diseases. Lifestyle changes such as increased physical activity improve a range of cardiometabolic risk factors. The objective of this study was to examine whether functional changes in adipose tissue were related to these improvements. Methods Seventy-three sedentary, overweight (mean BMI 29.9 ± 3.2 kg/m2) and abdominally obese, but otherwise healthy men and women (67.6 ± 0.5 years) from a randomised controlled trial of physical activity on prescription over a 6-month period were included (control n = 43, intervention n = 30). Detailed examinations were carried out at baseline and at follow-up, including fasting blood samples, a comprehensive questionnaire and subcutaneous adipose tissue biopsies for fatty acid composition analysis (n = 73) and quantification of mRNA expression levels of 13 candidate genes (n = 51), including adiponectin, leptin and inflammatory cytokines. Results At follow-up, the intervention group had a greater increase in exercise time (+137 min/week) and a greater decrease in body fat mass (−1.5 kg) compared to the control subjects (changes of 0 min/week and −0.5 kg respectively). Circulating concentrations of adiponectin were unchanged, but those of leptin decreased significantly more in the intervention group (−1.8 vs −1.1 ng/mL for intervention vs control, P < 0.05). The w6-polyunsaturated fatty acid content, in particular linoleic acid (18:2w6), of adipose tissue increased significantly more in the intervention group, but the magnitude of the change was small (+0.17 vs +0.02 percentage points for intervention vs control, P < 0.05). Surprisingly leptin mRNA levels in adipose tissue increased in the intervention group (+107% intervention vs −20% control, P < 0.05), but changes in expression of the remaining genes did not differ between the groups. Conclusions After a 6-month period of increased physical activity in

  6. Exercise-referral scheme to promote physical activity among hypertensive patients: design of a cluster randomized trial in the Primary Health Care Units of Mexico’s Social Security System

    PubMed Central

    2014-01-01

    Background Although the benefits of physical activity (PA) on to prevent and manage non-communicable diseases are well known, strategies to help increase the levels of PA among different populations are limited. Exercise-referral schemes have emerged as one effective approach to promote PA; however, there is uncertainty about the feasibility and effectiveness of these schemes in settings outside high-income countries. This study will examine the effectiveness of a scheme to refer hypertensive patients identified in Primary Health Care facilities (PHCU) of the Mexican social security institution to a group PA program offered in the same institution. Methods and design We will describe the methods of a cluster randomized trial study designed to evaluate the effectiveness of an exercise referral scheme to increasing physical activity in hypertensive patients compared to a non-referral scheme. Four PHCU were selected for the study; the PHCU will take part as the unit of randomization and sedentary hypertensive patients as the unit of assessment. 2 PHCU of control group (GC) will provide information to hypertensive patients about physical activity benefits and ways to increase it safely. 2 PHCU of intervention group (IG) will refer patients to sports facilities at the same institution, to follow a group-based PA program developed to increase the PA levels with a designed based on the Transtheoretical Model and Social Cognitive Theory. To evaluate the effects of the intervention as well as short-term maintenance of the intervention’s effects, PA will be assessed at baseline, at 24 and 32 weeks of follow-up. The main outcome will be the difference before and after intervention in the percentage of participants meeting recommended levels of PA between and within intervention and control groups. PA will be measured through self-report and with objective measure by accelerometer. Discussion This study will allow us to evaluate a multidisciplinary effort to link the primary

  7. Assessing the spatiotemporal evolution of neuronal activation with single-trial event-related potentials and functional MRI.

    PubMed

    Eichele, Tom; Specht, Karsten; Moosmann, Matthias; Jongsma, Marijtje L A; Quiroga, Rodrigo Quian; Nordby, Helge; Hugdahl, Kenneth

    2005-12-06

    The brain acts as an integrated information processing system, which methods in cognitive neuroscience have so far depicted in a fragmented fashion. Here, we propose a simple and robust way to integrate functional MRI (fMRI) with single trial event-related potentials (ERP) to provide a more complete spatiotemporal characterization of evoked responses in the human brain. The idea behind the approach is to find brain regions whose fMRI responses can be predicted by paradigm-induced amplitude modulations of simultaneously acquired single trial ERPs. The method was used to study a variant of a two-stimulus auditory target detection (odd-ball) paradigm that manipulated predictability through alternations of stimulus sequences with random or regular target-to-target intervals. In addition to electrophysiologic and hemodynamic evoked responses to auditory targets per se, single-trial modulations were expressed during the latencies of the P2 (170-ms), N2 (200-ms), and P3 (320-ms) components and predicted spatially separated fMRI activation patterns. These spatiotemporal matches, i.e., the prediction of hemodynamic activation by time-variant information from single trial ERPs, permit inferences about regional responses using fMRI with the temporal resolution provided by electrophysiology.

  8. Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials

    PubMed Central

    Sanchez, Zachary Carter; Herrington, James Murphy; Hensel, James Barrett; Henning, Nolan Michael; Scheckel, Caleb Josiah; Vassar, Matt

    2016-01-01

    Introduction With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals. Methods All randomized trials involving human subjects, pertaining to shoulder arthroplasty, published between July 1, 2005 and December 31, 2015, and indexed in either PubMed or SportDISCUS were analyzed. We assessed the prevalence of registration, the timing of registration relative to patient enrollment periods, and the variable rates of orthopedic journal compliance with ICMJE and Food and Drug Administration clinical registration standards for our study. Results Of the 382 articles identified, 345 (90.3%) were excluded due to failure to meet inclusion criteria. From the remaining 37, only 12 (32.4%) studies were found to be registered in a trial registry. Ten (10/12, 83.3%) of these provided their registration information within the body of the article. None of the included studies from ICMJE-recognized journals were registered. From 34 included studies from non-ICMJE recognized journals, 12 (35.3%) were registered. Conclusion The level of compliance with clinical trial registration guidelines in the decade since their release among shoulder arthroplasty trials in orthopedic journals is poor. Given the importance of the issue, the prevalence of the problem, and the fact that many other medical specialties have already made efforts to improve ICMJE compliance, further work on the part of orthopedic surgery journal authors and editors is needed to ensure the publication of unbiased results. Trial Registration UMIN000022487 PMID:27764210

  9. Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

    PubMed

    Johns, Claire; Seav, Susan M; Dominick, Sally A; Gorman, Jessica R; Li, Hongying; Natarajan, Loki; Mao, Jun James; Su, H Irene

    2016-04-01

    Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.

  10. The effect of school-based physical activity interventions on body mass index: a meta-analysis of randomized trials

    PubMed Central

    Guerra, Paulo Henrique; Nobre, Moacyr Roberto Cuce; da Silveira, Jonas Augusto Cardoso; de Aguiar Carrazedo Taddei, José Augusto

    2013-01-01

    This study reviewed the effectiveness of school-based physical activity interventions aimed at reducing overweight, obesity and hypertension in children. We searched 14 databases and analyzed studies published between April 2009 and September 2012. Only randomized controlled trials performed at the school level that included elements of physical activity but did not include nutritional co-interventions were analyzed. Studies were assessed by two recommended tools (EPHPP and GRADE), and the standardized mean differences with 95% confidence intervals were collected for a random-effect meta-analysis. A total of 12 papers were included in the meta-analysis, and these were divided according to three outcomes: body mass index (11 trials, n  =  4,273, −0.02, 95% CI: −0.13 to 0.17, p  =  0.8); body weight (5 trials, n  =  1,330, −0.07, 95% CI: −0.18 to 0.04, p  =  0.2); and blood pressure (6 trials, n  =  1,549), including systolic (0.11, 95% CI: −0.10 to 0.31, p  =  0.3) and diastolic pressure (−0.00, 95% CI: −0.10 to 0.10, p  =  0.9). This meta-analysis of data from 11 randomized, school-based physical activity interventions suggests that, regardless of the potential benefits of physical activity in the school environment, the interventions did not have a statistically significant effect. However, it is difficult to generalize from these results because the duration, intensity and type of physical activity used in the interventions varied greatly. PMID:24141844

  11. Peers Promoting Physical Activity among Breast Cancer Survivors: A Randomized Controlled Trial

    PubMed Central

    Pinto, Bernardine M.; Stein, Kevin; Dunsiger, Shira

    2015-01-01

    Objective Although studies have shown that physical activity (PA) can reduce some treatment-related side-effects of breast cancer, there is a need to offer PA programs outside of research settings to reach more cancer survivors. We partnered with the American Cancer Society's Reach to Recovery program (RTR) to train their volunteers (breast cancer survivors) to deliver a 12-week PA intervention to other breast cancer survivors. Methods We conducted a randomized controlled trial to compare the PA intervention delivered by RTR volunteers (PA plus RTR) with contact control (RTR Control). Eighteen RTR volunteers/coaches (mean age=54.9 years, mean years since diagnosis=7.0) delivered the contact control condition or the PA intervention. Seventy-six breast cancer survivors in New England (mean age=55.6 years, mean years since diagnosis=1.1) were randomized to one of the two groups. At baseline, 12 weeks (post-intervention) and at 24 weeks, participants wore an accelerometer for seven days, were interviewed about their PA and reported their motivational readiness for PA. Results Adjusted mixed effects longitudinal regression models showed significant group differences favoring the PA plus RTR group in minutes of moderate to vigorous PA at 12 weeks (mean difference=103 minutes/ week, p<.001) and 24 weeks (mean difference=34.7 minutes/week, p=.03). Results were corroborated with significant group differences in accelerometer data favoring the PA plus RTR group at both time-points. Conclusions Peer volunteers were able to significantly increase PA among cancer survivors relative to contact control. Partnerships with existing volunteer programs can help to widen the reach of behavioral interventions among cancer survivors. PMID:25110844

  12. Effects of Three Motivationally Targeted Mobile Device Applications on Initial Physical Activity and Sedentary Behavior Change in Midlife and Older Adults: A Randomized Trial

    PubMed Central

    Hekler, Eric B.; Grieco, Lauren A.; Winter, Sandra J.; Sheats, Jylana L.; Buman, Matthew P.; Banerjee, Banny; Robinson, Thomas N.; Cirimele, Jesse

    2016-01-01

    . Analytic app: d = 1.89,CI = 1.17, 2.61; Affect vs. Control app: d = 1.19,CI = 0.56, 1.81; Affect vs. Analytic app: d = 1.41,CI = 0.74, 2.07). Conclusion The results provide initial support for the use of a smartphone-delivered social frame in the early induction of both physical activity and sedentary behavior changes. The information obtained also sets the stage for further investigation of subgroups that might particularly benefit from different motivationally framed apps in these two key health promotion areas. Trial Registration ClinicalTrials.gov NCT01516411 PMID:27352250

  13. Image Registration: A Necessary Evil

    NASA Technical Reports Server (NTRS)

    Bell, James; McLachlan, Blair; Hermstad, Dexter; Trosin, Jeff; George, Michael W. (Technical Monitor)

    1995-01-01

    Registration of test and reference images is a key component of nearly all PSP data reduction techniques. This is done to ensure that a test image pixel viewing a particular point on the model is ratioed by the reference image pixel which views the same point. Typically registration is needed to account for model motion due to differing airloads when the wind-off and wind-on images are taken. Registration is also necessary when two cameras are used for simultaneous acquisition of data from a dual-frequency paint. This presentation will discuss the advantages and disadvantages of several different image registration techniques. In order to do so, it is necessary to propose both an accuracy requirement for image registration and a means for measuring the accuracy of a particular technique. High contrast regions in the unregistered images are most sensitive to registration errors, and it is proposed that these regions be used to establish the error limits for registration. Once this is done, the actual registration error can be determined by locating corresponding points on the test and reference images, and determining how well a particular registration technique matches them. An example of this procedure is shown for three transforms used to register images of a semispan model. Thirty control points were located on the model. A subset of the points were used to determine the coefficients of each registration transform, and the error with which each transform aligned the remaining points was determined. The results indicate the general superiority of a third-order polynomial over other candidate transforms, as well as showing how registration accuracy varies with number of control points. Finally, it is proposed that image registration may eventually be done away with completely. As more accurate image resection techniques and more detailed model surface grids become available, it will be possible to map raw image data onto the model surface accurately. Intensity

  14. Rectification and Registration of Remotely Sensed Data.

    DTIC Science & Technology

    2014-09-26

    intelligence Image registration Resampling Mapping Change detection Geometrical distortions Multisensor Signal processing Synthetic aperture radar...rectification and registration of images generated by onboard sensors. Accurate registration is a key requirement for detecting changes (in position...or "unwarping" of the image data before registration and information extraction, in the form of geometric and radiometric corrections and data

  15. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  16. 22 CFR 122.3 - Registration fees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Registration fees. 122.3 Section 122.3 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS REGISTRATION OF MANUFACTURERS AND EXPORTERS § 122.3 Registration fees. (a) Frequency of registration and fee. A person who is required...

  17. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  18. 49 CFR 390.201 - USDOT Registration.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 5 2014-10-01 2014-10-01 false USDOT Registration. 390.201 Section 390.201... SAFETY REGULATIONS; GENERAL Unified Registration System § 390.201 USDOT Registration. (a) Purpose. This section establishes who must register with FMCSA under the Unified Registration System, the...

  19. 9 CFR 381.179 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Registration. 381.179 Section 381.179... CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Records, Registration, and Reports § 381.179 Registration... effective date. All information submitted shall be current and correct. The registration form shall...

  20. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 16 2011-07-01 2011-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  1. 17 CFR 48.3 - Registration required.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 2 2014-04-01 2014-04-01 false Registration required. 48.3...) REGISTRATION OF FOREIGN BOARDS OF TRADE § 48.3 Registration required. (a) Except as specified in this part, it... Registration to the foreign board of trade pursuant to the provisions of this part. (b) It shall be...

  2. 17 CFR 48.5 - Registration procedures.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 2 2014-04-01 2014-04-01 false Registration procedures. 48.5...) REGISTRATION OF FOREIGN BOARDS OF TRADE § 48.5 Registration procedures. (a) A foreign board of trade seeking registration with the Commission pursuant to this part must electronically file an application for...

  3. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 17 2014-07-01 2014-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  4. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  5. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 4 2011-07-01 2011-07-01 false Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  6. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  7. 28 CFR 811.7 - Initial registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Initial registration. 811.7 Section 811.7... OFFENDER REGISTRATION § 811.7 Initial registration. (a) Duties of sex offender. (1) A sex offender must... purpose of registration, and must cooperate in such a meeting, including: (i) Providing any...

  8. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 17 2012-07-01 2012-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  9. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY LIQUORS BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  10. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  11. 28 CFR 811.7 - Initial registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Initial registration. 811.7 Section 811.7... OFFENDER REGISTRATION § 811.7 Initial registration. (a) Duties of sex offender. (1) A sex offender must... purpose of registration, and must cooperate in such a meeting, including: (i) Providing any...

  12. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  13. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 16 2011-07-01 2011-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  14. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  15. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 17 2014-07-01 2014-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  16. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY LIQUORS BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  17. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  18. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  19. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 17 2012-07-01 2012-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  20. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY ALCOHOL BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  1. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  2. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 4 2012-07-01 2011-07-01 true Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  3. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 7 2011-01-01 2011-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  4. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 7 2010-01-01 2010-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  5. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  6. 9 CFR 381.179 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Registration. 381.179 Section 381.179... CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Records, Registration, and Reports § 381.179 Registration... effective date. All information submitted shall be current and correct. The registration form shall...

  7. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY LIQUORS BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  8. 28 CFR 811.7 - Initial registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Initial registration. 811.7 Section 811.7... OFFENDER REGISTRATION § 811.7 Initial registration. (a) Duties of sex offender. (1) A sex offender must... purpose of registration, and must cooperate in such a meeting, including: (i) Providing any...

  9. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 7 2013-01-01 2013-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  10. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  11. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  12. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  13. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  14. 9 CFR 381.179 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Registration. 381.179 Section 381.179... CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Records, Registration, and Reports § 381.179 Registration... effective date. All information submitted shall be current and correct. The registration form shall...

  15. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  16. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 7 2014-01-01 2014-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  17. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 4 2013-07-01 2013-07-01 false Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  18. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 4 2014-07-01 2013-07-01 true Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  19. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  20. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  1. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY ALCOHOL BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  2. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  3. 9 CFR 381.179 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Registration. 381.179 Section 381.179... CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Records, Registration, and Reports § 381.179 Registration... effective date. All information submitted shall be current and correct. The registration form shall...

  4. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  5. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 7 2012-01-01 2012-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  6. 28 CFR 811.7 - Initial registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Initial registration. 811.7 Section 811.7... OFFENDER REGISTRATION § 811.7 Initial registration. (a) Duties of sex offender. (1) A sex offender must... purpose of registration, and must cooperate in such a meeting, including: (i) Providing any...

  7. Validation of histology image registration

    NASA Astrophysics Data System (ADS)

    Shojaii, Rushin; Karavardanyan, Tigran; Yaffe, Martin; Martel, Anne L.

    2011-03-01

    The aim of this paper is to validate an image registration pipeline used for histology image alignment. In this work a set of histology images are registered to their correspondent optical blockface images to make a histology volume. Then multi-modality fiducial markers are used to validate the alignment of histology images. The fiducial markers are catheters perfused with a mixture of cuttlefish ink and flour. Based on our previous investigations this fiducial marker is visible in medical images, optical blockface images and it can also be localized in histology images. The properties of this fiducial marker make it suitable for validation of the registration techniques used for histology image alignment. This paper reports on the accuracy of a histology image registration approach by calculation of target registration error using these fiducial markers.

  8. Data Requirements for Pesticide Registration

    EPA Pesticide Factsheets

    In evaluating a pesticide registration application, we assess a wide variety of potential human health and environmental effects associated with use of the product. Learn about these data requirements.

  9. Explanation of Registration Review Schedule

    EPA Pesticide Factsheets

    Updated information on EPA's schedule for opening dockets to begin pesticide registration reviews during the next several years. The schedule is subdivided into conventional pesticides, antimicrobials, biochemicals, and microbials. \

  10. Survey of Non-Rigid Registration Tools in Medicine.

    PubMed

    Keszei, András P; Berkels, Benjamin; Deserno, Thomas M

    2017-02-01

    We catalogue available software solutions for non-rigid image registration to support scientists in selecting suitable tools for specific medical registration purposes. Registration tools were identified using non-systematic search in Pubmed, Web of Science, IEEE Xplore® Digital Library, Google Scholar, and through references in identified sources (n = 22). Exclusions are due to unavailability or inappropriateness. The remaining (n = 18) tools were classified by (i) access and technology, (ii) interfaces and application, (iii) living community, (iv) supported file formats, and (v) types of registration methodologies emphasizing the similarity measures implemented. Out of the 18 tools, (i) 12 are open source, 8 are released under a permissive free license, which imposes the least restrictions on the use and further development of the tool, 8 provide graphical processing unit (GPU) support; (ii) 7 are built on software platforms, 5 were developed for brain image registration; (iii) 6 are under active development but only 3 have had their last update in 2015 or 2016; (iv) 16 support the Analyze format, while 7 file formats can be read with only one of the tools; and (v) 6 provide multiple registration methods and 6 provide landmark-based registration methods. Based on open source, licensing, GPU support, active community, several file formats, algorithms, and similarity measures, the tools Elastics and Plastimatch are chosen for the platform ITK and without platform requirements, respectively. Researchers in medical image analysis already have a large choice of registration tools freely available. However, the most recently published algorithms may not be included in the tools, yet.

  11. 75 FR 52859 - Re-Registration and Renewal of Aircraft Registration; OMB Approval of Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-30

    ... Federal Aviation Administration 14 CFR Parts 13, 47, and 91 RIN 2120-AI89 Re-Registration and Renewal of... final rule, ``Re-Registration and Renewal of Aircraft Registration,'' which was published on July 20..., the FAA published the final rule, ``Re-Registration and Renewal of Aircraft Registration'' (75...

  12. Teaching Drama Via Trials.

    ERIC Educational Resources Information Center

    Mansour, Wisam

    1998-01-01

    Suggests using a court trial as an activity for teaching drama to English-as-a-foreign-language (EFL) students. Describes use of a court trial for teaching Macbeth to EFL students in Jordan. (Author/VWL)

  13. Improvement of registration accuracy in accelerated partial breast irradiation using the point-based rigid-body registration algorithm for patients with implanted fiducial markers

    SciTech Connect

    Inoue, Minoru; Yoshimura, Michio Sato, Sayaka; Nakamura, Mitsuhiro; Yamada, Masahiro; Hirata, Kimiko; Ogura, Masakazu; Hiraoka, Masahiro; Sasaki, Makoto; Fujimoto, Takahiro

    2015-04-15

    Purpose: To investigate image-registration errors when using fiducial markers with a manual method and the point-based rigid-body registration (PRBR) algorithm in accelerated partial breast irradiation (APBI) patients, with accompanying fiducial deviations. Methods: Twenty-two consecutive patients were enrolled in a prospective trial examining 10-fraction APBI. Titanium clips were implanted intraoperatively around the seroma in all patients. For image-registration, the positions of the clips in daily kV x-ray images were matched to those in the planning digitally reconstructed radiographs. Fiducial and gravity registration errors (FREs and GREs, respectively), representing resulting misalignments of the edge and center of the target, respectively, were compared between the manual and algorithm-based methods. Results: In total, 218 fractions were evaluated. Although the mean FRE/GRE values for the manual and algorithm-based methods were within 3 mm (2.3/1.7 and 1.3/0.4 mm, respectively), the percentages of fractions where FRE/GRE exceeded 3 mm using the manual and algorithm-based methods were 18.8%/7.3% and 0%/0%, respectively. Manual registration resulted in 18.6% of patients with fractions of FRE/GRE exceeding 5 mm. The patients with larger clip deviation had significantly more fractions showing large FRE/GRE using manual registration. Conclusions: For image-registration using fiducial markers in APBI, the manual registration results in more fractions with considerable registration error due to loss of fiducial objectivity resulting from their deviation. The authors recommend the PRBR algorithm as a safe and effective strategy for accurate, image-guided registration and PTV margin reduction.

  14. The Influence of Wireless Self-Monitoring Program on the Relationship Between Patient Activation and Health Behaviors, Medication Adherence, and Blood Pressure Levels in Hypertensive Patients: A Substudy of a Randomized Controlled Trial

    PubMed Central

    Kim, Ju Young; Wineinger, Nathan. E

    2016-01-01

    Background Active engagement in the management of hypertension is important in improving self-management behaviors and clinical outcomes. Mobile phone technology using wireless monitoring tools are now widely available to help individuals monitor their blood pressure, but little is known about the conditions under which such technology can effect positive behavior changes or clinical outcomes. Objective To study the influence of wireless self-monitoring program and patient activation measures on health behaviors, medication adherence, and blood pressure levels as well as control of blood pressure in hypertensive patients. Methods We examined a subset of 95 hypertensive participants from a 6-month randomized controlled trial designed to determine the utility of a wireless self-monitoring program (n=52 monitoring program, n=43 control), which consisted of a blood pressure monitoring device connected with a mobile phone, reminders for self-monitoring, a Web-based disease management program, and a mobile app for monitoring and education, compared with the control group receiving a standard disease management program. Study participants provided measures of patient activation, health behaviors including smoking, drinking, and exercise, medication adherence, and blood pressure levels. We assessed the influence of wireless self-monitoring as a moderator of the relationship between patient activation and health behaviors, medication adherence, and control of blood pressure. Results Improvements in patient activation were associated with improvements in cigarette smoking (beta=−0.46, P<.001) and blood pressure control (beta=0.04, P=.02). This relationship was further strengthened in reducing cigarettes (beta=−0.60, P<.001), alcohol drinking (beta=−0.26, P=.01), and systolic (beta=−0.27, P=.02) and diastolic blood pressure (beta=−0.34, P=.007) at 6 months among individuals participating in the wireless self-monitoring program. No differences were observed with

  15. Streamlining the design of promising clinical trials: in-vitro testing of antithrombotic regimens and multiple agonists of platelet activation.

    PubMed

    Schneider, David J; Sobel, Burton E

    2009-03-01

    Platelets are activated in vivo by multiple agonists; however, platelet function testing in vitro has been performed predominantly with only one or two agonists of platelet activation. Greater insight into anticipated effects of antithrombotic regimens should enhance the design of successful clinical trials. To test this concept, we assessed platelet activation induced by multiple agonists and two antithrombotic regimens, unfractionated heparin (UFH) and eptifibatide compared with bivalirudin and cangrelor. Blood samples from 10 patients with coronary artery disease were spiked with pharmacologic concentrations achieved in vivo of either UFH (1.2 U/ml) and eptifibatide (1.7 microg/ml), or with bivalirudin (8 microg/ml) and cangrelor (500 nmol/l). Platelet function was assessed with the use of flow cytometry. Agonists included thrombin (50 nmol/l), adenosine diphosphate (1 micromol/l), the collagen-mimetic convulxin (5 ng/ml), and platelet-activating factor (10 nmol/l). When platelet activation was identified by the surface expression of P-selectin in response to multiple agonists, the combination of bivalirudin and cangrelor suppressed activation more than UFH and eptifibatide. When platelet activation was identified by the activation of glycoprotein IIb-IIIa (PAC-1 binding), the combination of bivalirudin and cangrelor was more effective in suppressing activation in response to thrombin and adenosine diphosphate, whereas UFH and eptifibatide more effectively prevented binding of PAC-1 when platelets were activated with the collagen-mimetic convulxin. In conclusion, bivalirudin and cangrelor suppressed platelet activation in response to diverse agonists in vitro more than UFH and eptifibatide. These results and this approach to selection of promising interventions should be helpful in streamlining the design of clinical trials.

  16. A double-blind atropine trial for active learning of autonomic function.

    PubMed

    Fry, Jeffrey R; Burr, Steven A

    2011-12-01

    Here, we describe a human physiology laboratory class measuring changes in autonomic function over time in response to atropine. Students use themselves as subjects, generating ownership and self-interest in the learning as well as directly experiencing the active link between physiology and pharmacology in people. The class is designed to concomitantly convey the importance of bias in experimentation by adopting a double-blind placebo-controlled approach. We have used this class effectively in various forms with ∼600 students receiving atropine over the last 16 yr. This class has received favorable feedback from staff and students of medicine, pharmacy, and neuroscience, and we recommend it for such undergraduates. The learning objectives that students are expected to achieve are to be able to 1) know the ethical, safety, and hygiene requirements for using human volunteers as subjects; 2) implement and explain a double-blind placebo-controlled trial; 3) design, agree, and execute a protocol for making (and accurately recording) precise reproducible measurements of pulse rate, pupil diameter, and salivary flow; 4) evaluate the importance of predose periods and measurement consistency to detect effects (including any reversibility) after an intervention; 5) experience direct cause-and-effect relationships integrating physiology with pharmacology in people; 6) calculate appropriate summary statistics to describe the data and determine the data's statistical significance; 7) recognize normal variability both within and between subjects in baseline physiological parameters and also recognize normal variability in response to pharmacological treatment; 8) infer the distribution and role of muscarinic receptors in the autonomic nervous system with respect to the heart, eye, and mouth; 9) identify and explain the clinical significance of differences in effect due to the route and formulation of atropine; 10) produce and deliver a concise oral presentation of

  17. Results from The LIFE Piolt Study: A Trial of Physical Activity for Disability Prevention

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The increasing number of older Americans has made disability prevention a high public health priority. Considerable evidence points to exercise as a promising strategy to prevent disability, but definitive evidence from phase III clinical trials is lacking. The objective of the Lifestyle Intervent...

  18. Brief Behavioral Activation and Problem-Solving Therapy for Depressed Breast Cancer Patients: Randomized Trial

    ERIC Educational Resources Information Center

    Hopko, Derek R.; Armento, Maria E. A.; Robertson, Sarah M. C.; Ryba, Marlena M.; Carvalho, John P.; Colman, Lindsey K.; Mullane, Christen; Gawrysiak, Michael; Bell, John L.; McNulty, James K.; Lejuez, Carl W.

    2011-01-01

    Objective: Major depression is the most common psychiatric disorder among breast cancer patients and is associated with substantial impairment. Although some research has explored the utility of psychotherapy with breast cancer patients, only 2 small trials have investigated the potential benefits of behavior therapy among patients with…

  19. Hyperbolic Harmonic Mapping for Surface Registration.

    PubMed

    Shi, Rui; Zeng, Wei; Su, Zhengyu; Jiang, Jian; Damasio, Hanna; Lu, Zhonglin; Wang, Yalin; Yau, Shing-Tung; Gu, Xianfeng

    2016-05-12

    Automatic computation of surface correspondence via harmonic map is an active research field in computer vision, computer graphics and computational geometry. It may help document and understand physical and biological phenomena and also has broad applications in biometrics, medical imaging and motion capture inducstries. Although numerous studies have been devoted to harmonic map research, limited progress has been made to compute a diffeomorphic harmonic map on general topology surfaces with landmark constraints. This work conquers this problem by changing the Riemannian metric on the target surface to a hyperbolic metric so that the harmonic mapping is guaranteed to be a diffeomorphism under landmark constraints. The computational algorithms are based on Ricci flow and nonlinear heat diffusion methods. The approach is general and robust. We employ our algorithm to study the constrained surface registration problem which applies to both computer vision and medical imaging applications. Experimental results demonstrate that, by changing the Riemannian metric, the registrations are always diffeomorphic and achieve relatively high performance when evaluated with some popular surface registration evaluation standards.

  20. A Method for Utilizing Bivariate Efficacy Outcome Measures to Screen Regimens for Activity in 2-Stage Phase II Clinical Trials

    PubMed Central

    Rubinstein, Larry; Litwin, Samuel; Yothers, Greg

    2012-01-01

    Background Most phase II clinical trials utilize a single primary endpoint to determine the promise of a regimen for future study. However, many disorders manifest themselves in complex ways. For example, migraine headaches can cause pain, auras, photophobia, and emesis. Investigators may believe a drug is effective at reducing migraine pain and the severity of emesis during an attack. Nevertheless, they could still be interested in proceeding with development of the drug if it is effective against only one of these symptoms. Such a study would be a candidate for a clinical trial with co-primary endpoints. Purpose The purpose of the article is to provide a method for designing a 2-stage clinical trial with dichotomous co-primary endpoints of efficacy that has the ability to detect activity on either response measure with high probability when the drug is active on one or both measures, while at the same time rejecting the drug with high probability when there is little activity on both dimensions. The design enables early closure for futility and is flexible with regard to attained accrual. Methods The design is proposed in the context of cancer clinical trials where tumor response is used to assess a drug's ability to kill tumor cells and progression-free survival (PFS) status after a certain period is used to evaluate the drug's ability to stabilize tumor growth. Both endpoints are assumed to be distributed as binomial random variables, and uninteresting probabilities of success are determined from historical controls. Given the necessity of accrual flexibility, exhaustive searching algorithms to find optimum designs do not seem feasible at this time. Instead, critical values are determined for realized sample sizes using specific procedures. Then accrual windows are found to achieve a design's desired level of significance, probability of early termination (PET), and power. Results The design is illustrated with a clinical trial that examined bevacizumab in

  1. A mouse-human phase 1 co-clinical trial of a protease-activated fluorescent probe for imaging cancer

    PubMed Central

    Whitley, Melodi Javid; Cardona, Diana M.; Lazarides, Alexander L.; Spasojevic, Ivan; Ferrer, Jorge M.; Cahill, Joan; Lee, Chang-Lung; Snuderl, Matija; Blazer, Dan G.; Hwang, E. Shelley; Greenup, Rachel A.; Mosca, Paul J.; Mito, Jeffrey K.; Cuneo, Kyle C.; Larrier, Nicole A.; O’Reilly, Erin K.; Riedel, Richard F.; Eward, William C.; Strasfeld, David B.; Fukumura, Dai; Jain, Rakesh K.; Lee, W. David; Griffith, Linda G.; Bawendi, Moungi G.; Kirsch, David G.; Brigman, Brian E.

    2016-01-01

    Local recurrence is a common cause of treatment failure for patients with solid tumors. Intraoperative detection of microscopic residual cancer in the tumor bed could be used to decrease the risk of a positive surgical margin, reduce rates of reexcision, and tailor adjuvant therapy. We used a protease-activated fluorescent imaging probe, LUM015, to detect cancer in vivo in a mouse model of soft tissue sarcoma (STS) and ex vivo in a first-in-human phase 1 clinical trial. In mice, intravenous injection of LUM015 labeled tumor cells, and residual fluorescence within the tumor bed predicted local recurrence. In 15 patients with STS or breast cancer, intravenous injection of LUM015 before surgery was well tolerated. Imaging of resected human tissues showed that fluorescence from tumor was significantly higher than fluorescence from normal tissues. LUM015 biodistribution, pharmacokinetic profiles, and metabolism were similar in mouse and human subjects. Tissue concentrations of LUM015 and its metabolites, including fluorescently labeled lysine, demonstrated that LUM015 is selectively distributed to tumors where it is activated by proteases. Experiments in mice with a constitutively active PEGylated fluorescent imaging probe support a model where tumor-selective probe distribution is a determinant of increased fluorescence in cancer. These co-clinical studies suggest that the tumor specificity of protease-activated imaging probes, such as LUM015, is dependent on both biodistribution and enzyme activity. Our first-in-human data support future clinical trials of LUM015 and other protease-sensitive probes. PMID:26738797

  2. A mouse-human phase 1 co-clinical trial of a protease-activated fluorescent probe for imaging cancer.

    PubMed

    Whitley, Melodi Javid; Cardona, Diana M; Lazarides, Alexander L; Spasojevic, Ivan; Ferrer, Jorge M; Cahill, Joan; Lee, Chang-Lung; Snuderl, Matija; Blazer, Dan G; Hwang, E Shelley; Greenup, Rachel A; Mosca, Paul J; Mito, Jeffrey K; Cuneo, Kyle C; Larrier, Nicole A; O'Reilly, Erin K; Riedel, Richard F; Eward, William C; Strasfeld, David B; Fukumura, Dai; Jain, Rakesh K; Lee, W David; Griffith, Linda G; Bawendi, Moungi G; Kirsch, David G; Brigman, Brian E

    2016-01-06

    Local recurrence is a common cause of treatment failure for patients with solid tumors. Intraoperative detection of microscopic residual cancer in the tumor bed could be used to decrease the risk of a positive surgical margin, reduce rates of reexcision, and tailor adjuvant therapy. We used a protease-activated fluorescent imaging probe, LUM015, to detect cancer in vivo in a mouse model of soft tissue sarcoma (STS) and ex vivo in a first-in-human phase 1 clinical trial. In mice, intravenous injection of LUM015 labeled tumor cells, and residual fluorescence within the tumor bed predicted local recurrence. In 15 patients with STS or breast cancer, intravenous injection of LUM015 before surgery was well tolerated. Imaging of resected human tissues showed that fluorescence from tumor was significantly higher than fluorescence from normal tissues. LUM015 biodistribution, pharmacokinetic profiles, and metabolism were similar in mouse and human subjects. Tissue concentrations of LUM015 and its metabolites, including fluorescently labeled lysine, demonstrated that LUM015 is selectively distributed to tumors where it is activated by proteases. Experiments in mice with a constitutively active PEGylated fluorescent imaging probe support a model where tumor-selective probe distribution is a determinant of increased fluorescence in cancer. These co-clinical studies suggest that the tumor specificity of protease-activated imaging probes, such as LUM015, is dependent on both biodistribution and enzyme activity. Our first-in-human data support future clinical trials of LUM015 and other protease-sensitive probes.

  3. Methods and baseline characteristics of a randomized trial treating early childhood obesity: The Positive Lifestyles for Active Youngsters (Team PLAY) trial

    PubMed Central

    Hare, Marion; Coday, Mace; Williams, Natalie A.; Richey, Phyllis; Tylavsky, Frances; Bush, Andrew

    2012-01-01

    There are few effective obesity interventions directed towards younger children, particularly young minority children. This paper describes the design, intervention, recruitment methods, and baseline data of the ongoing Positive Lifestyles for Active Youngsters (Team PLAY) study. This randomized controlled trial is designed to test the efficacy of a 6-month, moderately intense, primary care feasible, family-based behavioral intervention, targeting both young children and their parent, in promoting healthy weight change. Participants are 270 overweight and obese children (ages 4 to 7 years) and their parent, who were recruited from a primarily African American urban population. Parents and children were instructed in proven cognitive behavioral techniques (e.g. goal setting, self-talk, stimulus control and reinforcement) designed to encourage healthier food choices (more whole grains, fruits and vegetables, and less concentrated fats and sugar), reduce portion sizes, decrease sweetened beverages and increase moderate to vigorous physical activity engagement. The main outcome of this study is change in BMI at two years post enrollment. Recruitment using reactive methods (mailings, TV ads, pamphlets) was found to be more successful than using only a proactive approach (referral through physicians). At baseline, most children were very obese with an average BMI z-score of 2.6. Reported intake of fruits and vegetables and minutes of moderate to vigorous physical activity engagement did not meet national recommendations. If efficacious, Team PLAY would offer a model for obesity treatment directed at families with young children that could be tested and translated to both community and primary care settings. PMID:22342450

  4. Methods and baseline characteristics of a randomized trial treating early childhood obesity: the Positive Lifestyles for Active Youngsters (Team PLAY) trial.

    PubMed

    Hare, Marion E; Coday, Mace; Williams, Natalie A; Richey, Phyllis A; Tylavsky, Frances A; Bush, Andrew J

    2012-05-01

    There are few effective obesity interventions directed towards younger children, particularly young minority children. This paper describes the design, intervention, recruitment methods, and baseline data of the ongoing Positive Lifestyles for Active Youngsters (Team PLAY) study. This randomized controlled trial is designed to test the efficacy of a 6-month, moderately intense, primary care feasible, family-based behavioral intervention, targeting both young children and their parent, in promoting healthy weight change. Participants are 270 overweight and obese children (ages 4 to 7 years) and their parents, who were recruited from a primarily African American urban population. Parents and children were instructed in proven cognitive behavioral techniques (e.g. goal setting, self-talk, stimulus control and reinforcement) designed to encourage healthier food choices (more whole grains, fruits and vegetables, and less concentrated fats and sugar), reduce portion sizes, decrease sweetened beverages and increase moderate to vigorous physical activity engagement. The main outcome of this study is change in BMI at two year post enrollment. Recruitment using reactive methods (mailings, TV ads, pamphlets) was found to be more successful than using only a proactive approach (referral through physicians). At baseline, most children were very obese with an average BMI z-score of 2.6. Reported intake of fruits and vegetables and minutes of moderate to vigorous physical activity engagement did not meet national recommendations. If efficacious, Team PLAY would offer a model for obesity treatment directed at families with young children that could be tested and translated to both community and primary care settings.

  5. Decoding the individual finger movements from single-trial functional magnetic resonance imaging recordings of human brain activity.

    PubMed

    Shen, Guohua; Zhang, Jing; Wang, Mengxing; Lei, Du; Yang, Guang; Zhang, Shanmin; Du, Xiaoxia

    2014-06-01

    Multivariate pattern classification analysis (MVPA) has been applied to functional magnetic resonance imaging (fMRI) data to decode brain states from spatially distributed activation patterns. Decoding upper limb movements from non-invasively recorded human brain activation is crucial for implementing a brain-machine interface that directly harnesses an individual's thoughts to control external devices or computers. The aim of this study was to decode the individual finger movements from fMRI single-trial data. Thirteen healthy human subjects participated in a visually cued delayed finger movement task, and only one slight button press was performed in each trial. Using MVPA, the decoding accuracy (DA) was computed separately for the different motor-related regions of interest. For the construction of feature vectors, the feature vectors from two successive volumes in the image series for a trial were concatenated. With these spatial-temporal feature vectors, we obtained a 63.1% average DA (84.7% for the best subject) for the contralateral primary somatosensory cortex and a 46.0% average DA (71.0% for the best subject) for the contralateral primary motor cortex; both of these values were significantly above the chance level (20%). In addition, we implemented searchlight MVPA to search for informative regions in an unbiased manner across the whole brain. Furthermore, by applying searchlight MVPA to each volume of a trial, we visually demonstrated the information for decoding, both spatially and temporally. The results suggest that the non-invasive fMRI technique may provide informative features for decoding individual finger movements and the potential of developing an fMRI-based brain-machine interface for finger movement.

  6. Skeleton Graph Matching vs. Maximum Weight Cliques aorta registration techniques.

    PubMed

    Czajkowska, Joanna; Feinen, C; Grzegorzek, M; Raspe, M; Wickenhöfer, R

    2015-12-01

    Vascular diseases are one of the most challenging health problems in developed countries. Past as well as ongoing research activities often focus on efficient, robust and fast aorta segmentation, and registration techniques. According to this needs our study targets an abdominal aorta registration method. The investigated algorithms make it possible to efficiently segment and register abdominal aorta in pre- and post-operative Computed Tomography (CT) data. In more detail, a registration technique using the Path Similarity Skeleton Graph Matching (PSSGM), as well as Maximum Weight Cliques (MWCs) are employed to realise the matching based on Computed Tomography data. The presented approaches make it possible to match characteristic voxels belonging to the aorta from different Computed Tomography (CT) series. It is particularly useful in the assessment of the abdominal aortic aneurysm treatment by visualising the correspondence between the pre- and post-operative CT data. The registration results have been tested on the database of 18 contrast-enhanced CT series, where the cross-registration analysis has been performed producing 153 matching examples. All the registration results achieved with our system have been verified by an expert. The carried out analysis has highlighted the advantage of the MWCs technique over the PSSGM method. The verification phase proves the efficiency of the MWCs approach and encourages to further develop this methods.

  7. Petition for Rulemaking to Evaluate Synergestic Effects of Pesticides during Registration and Registration Review

    EPA Pesticide Factsheets

    This petition from the Center for Biological Diversity asks that the Agency require all applicants and registrants to provide data on the potential synergistic effects of pesticides during the registration and registration review processes.

  8. 21 CFR 1309.42 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...; denial of registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 511) to..., shall hold a hearing on the application pursuant to § 1309.51. (b) The Certificate of Registration...

  9. 21 CFR 1301.35 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if... Federal Register. (c) The Certificate of Registration (DEA Form 223) shall contain the name, address,...

  10. The Effect of Sensor Registration Error on the Performance of PMHT

    DTIC Science & Technology

    2008-07-01

    Specifically, the probability of track hold as a function of target SNR and registration error between two receivers will be evaluated via...range of relevant target SNR values. Index Terms- Probabilistic Multi-hypothesis Tracker, multi-static active sonar, target tracking, registration...variability in observed target SNR by different receivers, limitations on sensor coverage and overlap, imperfect sensor registration, and choice of processing

  11. The Effects of the UK Pregnancies Better Eating and Activity Trial Intervention on Dietary Patterns in Obese Pregnant Women Participating in a Pilot Randomized Controlled Trial

    PubMed Central

    Flynn, Angela C.; Schneeberger, Caroline; Seed, Paul T.; Barr, Suzanne; Poston, Lucilla; Goff, Louise M.

    2015-01-01

    OBJECTIVE The objective of this study is to investigate the effects of the UK Pregnancies Better Eating and Activity Trial (UPBEAT) behavioral intervention on dietary patterns in obese pregnant women. METHODS Dietary patterns were derived from Food Frequency Questionnaires using principal component analysis in 183 UPBEAT pilot study participants. RESULTS Two unhealthy dietary patterns, processed and traditional, predominantly characterized by foods high in sugar and fat, improved [processed −0.54 (−0.92 to −0.16), P = 0.006 and traditional −0.83 (−1.20 to −0.45), P < 0.001] following the intervention, while a cultural pattern that was found to be associated with the Black African/Caribbean participants did not change [−0.10 (−0.46 to 0.26), P = 0.589]. CONCLUSION Unhealthy dietary patterns are evident in obese pregnant women. The UPBEAT intervention was effective in improving maternal dietary patterns; however, obese pregnant women from minority ethnic groups may be less receptive to intervention. PMID:27385914

  12. Power considerations for trials of two experimental arms versus a standard active control or placebo.

    PubMed

    Hasselblad, Vic

    2016-10-01

    The power of the two-experimental arm trial depends on three choices: (1) when one arm is dropped (if at all); (2) the final testing procedure, assuming no dropping; and (3) the sampling ratio for the three arms. Multiple-arm designs require critical values which were calculated using Mathematica. Power calculations were exact based on probabilities from binomial distributions. The "drop the loser" strategy is optimal for the primary endpoint. The equal sized two treated arm trial gives reasonable power for the primary as well as good power to select the best treated arm. The best power was provided by the 3:3:4 sampling, but it was only marginally better.

  13. Filtering noise for synchronised activity in multi-trial electrophysiology data using Wiener and Kalman filters.

    PubMed

    Zhan, Yang; Guo, Shuixia; Kendrick, Keith M; Feng, Jianfeng

    2009-04-01

    Novel approaches to effectively reduce noise in data recorded from multi-trial physiology experiments have been investigated using two-dimensional filtering methods, adaptive Wiener filtering and reduced update Kalman filtering. Test data based on signal and noise model consisting of different conditions of signal components mixed with noise have been considered with filtering effects evaluated using analysis of frequency coherence and of time-dependent coherence. Various situations that may affect the filtering results have been explored and reveal that Wiener and Kalman filtering can considerably improve the coherence values between two channels of multi-trial data and suppress uncorrelated components. We have extended our approach to experimental data: multi-electrode array (MEA) local field potential (LFPs) recordings from the inferotemporal cortex of sheep and LFP vs. electromyogram (LFP-EMG) recording data during resting tremor in Parkinson's disease patients. Finally general procedures for implementation of these filtering techniques are described.

  14. In vitro activity of tigecycline against patient isolates collected during phase 3 clinical trials for hospital acquired pneumonia.

    PubMed

    Petersen, Peter J; Tuckman, Margareta; Jones, C Hal

    2010-02-03

    The in vitro activity of tigecycline was evaluated against 819 baseline pathogens isolated from 383 patients enrolled in the phase 3 clinical trial investigating the efficacy of tigecycline in hospital acquired pneumonia (HAP). The trials were global, enrolling patients in 27 countries. Tigecycline was active against the most prevalent pathogens in HAP, including gram-positive and gram-negative strains (90% of MICs ≤2 µg/mL for the entire collection). The spectrum of activity of tigecycline included important pathogens such as Staphylococcus aureus (including methicillin-resistant S. aureus), Enterococcus faecalis, Streptococcus pneumoniae, Acinetobacter baumannii/calcoaceticus complex, Escherichia coli, Klebsiella pneumonia, and Enterobacter cloacae. As reported previously, a few genera, such as Pseudomonas aeruginosa and the Proteeae, were generally less susceptible to tigecycline by comparison to other gram-negative pathogens. The excellent in vitro, expanded, broad-spectrum activity of tigecycline in the clinical isolates confirmed the potential utility of tigecycline for pathogens associated with with hospital acquired pneumonia infections.

  15. In vitro activity of tigecycline against patient isolates collected during phase 3 clinical trials for diabetic foot infections.

    PubMed

    Petersen, Peter J; Ruzin, Alexey; Tuckman, Margareta; Jones, C Hal

    2010-04-01

    The in vitro activity of tigecycline and comparative antimicrobial agents was evaluated against 1828 primary baseline pathogens isolated from 844 patients enrolled in the phase 3 clinical trials investigating the efficacy of tigecycline in diabetic foot infection (DFI). The trials were global, enrolling patients in 30 countries. Tigecycline was active against the most prevalent pathogens in DFI, including Gram-positive and Gram-negative isolates of both aerobic and anaerobic bacteria with 95% of MICs < or =2 microg/mL for the entire collection. The spectrum of activity of tigecycline included important pathogens for DFI, such as Staphylococcus aureus, Enterococcus faecalis, Streptococcus agalactiae, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis. As reported previously, Pseudomonas aeruginosa and several pathogens in the Proteeae group were generally less susceptible to tigecycline by comparison to other Gram-negative pathogens. The excellent in vitro expanded broad-spectrum activity of tigecycline in the clinical isolates confirmed the potential utility of tigecycline for pathogens associated with DFIs.

  16. In vitro activity of tigecycline against patient isolates collected during phase 3 clinical trials for hospital acquired pneumonia

    PubMed Central

    Petersen, Peter J.; Tuckman, Margareta; Jones, C. Hal

    2010-01-01

    The in vitro activity of tigecycline was evaluated against 819 baseline pathogens isolated from 383 patients enrolled in the phase 3 clinical trial investigating the efficacy of tigecycline in hospital acquired pneumonia (HAP). The trials were global, enrolling patients in 27 countries. Tigecycline was active against the most prevalent pathogens in HAP, including gram-positive and gram-negative strains (90% of MICs ≤2 µg/mL for the entire collection). The spectrum of activity of tigecycline included important pathogens such as Staphylococcus aureus (including methicillin-resistant S. aureus), Enterococcus faecalis, Streptococcus pneumoniae, Acinetobacter baumannii/calcoaceticus complex, Escherichia coli, Klebsiella pneumonia, and Enterobacter cloacae. As reported previously, a few genera, such as Pseudomonas aeruginosa and the Proteeae, were generally less susceptible to tigecycline by comparison to other gram-negative pathogens. The excellent in vitro, expanded, broad-spectrum activity of tigecycline in the clinical isolates confirmed the potential utility of tigecycline for pathogens associated with with hospital acquired pneumonia infections. PMID:24470884

  17. Detection of Cystic Fibrosis Transmembrane Conductance Regulator Activity in Early-Phase Clinical Trials

    PubMed Central

    Rowe, Steven M.; Accurso, Frank; Clancy, John P.

    2007-01-01

    Advances in our understanding of cystic fibrosis pathogenesis have led to strategies directed toward treatment of underlying causes of the disease rather than treatments of disease-related symptoms. To expedite evaluation of these emerging therapies, early-phase clinical trials require extension of in vivo cystic fibrosis transmembrane conductance regulator (CFTR)–detecting assays to multicenter trial formats, including nasal potential difference and sweat chloride measurements. Both of these techniques can be used to fulfill diagnostic criteria for the disease, and can discriminate various levels of CFTR function. Full realization of these assays in multicenter clinical trials requires identification of sources of nonbiological intra- and intersite variability, and careful attention to study design and statistical analysis of study-generated data. In this review, we discuss several issues important to the performance of these assays, including efforts to identify and address aspects that can contribute to inconsistent and/or potentially erroneous results. Adjunctive means of detecting CFTR including mRNA expression, immunocytochemical localization, and other methods are also discussed. Recommendations are presented to advance our understanding of these biomarkers and to improve their capacity to predict cystic fibrosis outcomes. PMID:17652506

  18. Activity of 129 Single-Agent Drugs in 228 Phase I and II Clinical Trials in Multiple Myeloma

    PubMed Central

    Kortuem, K. Martin; Zidich, Kaitlyn; Schuster, Steven R.; Khan, Meaghan L.; Jimenez-Zepeda, Victor H.; Mikhael, Joseph R.; Fonseca, Rafael; Stewart, A. Keith

    2014-01-01

    Background More than 400 preclinical studies report ≥ 1 compound as cytotoxic to multiple myeloma (MM) cells; however, few of these agents became relevant in the clinic. Thus, the utility of such assays in predicting future clinical value is debatable. Patients and Methods We examined the application of early-phase trial experiences to predict future clinical adoption. We identified 129 drugs explored as single agents in 228 trials involving 7421 patients between 1961 and 2013. Results All drugs in common use in MM (melphalan, dexamethasone, prednisone, cyclophosphamide, bendamustine, thalidomide, lenalidomide, pomalidomide, bortezomib, carfilzomib, and doxorubicin) demonstrated a best reported response rate of ≥ 22%. Older agents, including teniposide, fotemustine, paclitaxel, and interferon, also appear active by this criterion; however, if mean response rates from all reported trials for an agent are considered, then only drugs with a mean response rate of 15% partial response are in clinical use. Conclusion Our analysis suggests that thresholds of 20% for best or 15% for mean response are highly predictive of future clinical success. Below these thresholds, no drug has yet reached regulatory approval or widespread use in the clinic. Thus, this benchmark provides 1 element of the framework for guiding choice of drugs for late-stage clinical testing. PMID:24565465

  19. Pesticide Registration Manual: Chapter 10 - Data Compensation Requirements

    EPA Pesticide Factsheets

    This chapter provides information about data compensation requirements, procedures, and obligations when submitting an application for registration, amended registration, reregistration or registration review.

  20. Contacts in the Office of Pesticide Programs, Registration Division

    EPA Pesticide Factsheets

    The Registration Division (RD) is responsible product registrations, amendments, registrations, tolerances, experimental use permits, and emergency exemptions for conventional chemical pesticides. Find contacts in this division.

  1. Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Background Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified ‘constraint-induced movement therapy (CIMT) at home’) with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. ‘CIMT at home’ will be compared with conventional physical and occupational therapy (‘therapy as usual’). Methods/design The study is a parallel cluster randomized controlled trial with therapy practices as clusters (n = 48). After written consent from the patients (n = 144), the therapists will be randomly assigned to treat either the intervention or the control group. Blinded external assessors will evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are the motor activity log (quality of arm and hand use) and the Wolf motor function test (arm and hand function). These assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes will be analyzed with mixed models, which consider the hierarchical structure of the data and will be adjusted to the baseline measurements and sex. The primary analysis will be the comparison of the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints will be tested at the

  2. Intraoperative ultrasound to stereocamera registration using interventional photoacoustic imaging

    NASA Astrophysics Data System (ADS)

    Vyas, Saurabh; Su, Steven; Kim, Robert; Kuo, Nathanael; Taylor, Russell H.; Kang, Jin U.; Boctor, Emad M.

    2012-02-01

    There are approximately 6000 hospitals in the United States, of which approximately 5400 employ minimally invasive surgical robots for a variety of procedures. Furthermore, 95% of these robots require extensive registration before they can be fitted into the operating room. These "registrations" are performed by surgical navigation systems, which allow the surgical tools, the robot and the surgeon to be synchronized together-hence operating in concert. The most common surgical navigation modalities include: electromagnetic (EM) tracking and optical tracking. Currently, these navigation systems are large, intrusive, come with a steep learning curve, require sacrifices on the part of the attending medical staff, and are quite expensive (since they require several components). Recently, photoacoustic (PA) imaging has become a practical and promising new medical imaging technology. PA imaging only requires the minimal equipment standard with most modern ultrasound (US) imaging systems as well as a common laser source. In this paper, we demonstrate that given a PA imaging system, as well as a stereocamera (SC), the registration between the US image of a particular anatomy and the SC image of the same anatomy can be obtained with reliable accuracy. In our experiments, we collected data for N = 80 trials of sample 3D US and SC coordinates. We then computed the registration between the SC and the US coordinates. Upon validation, the mean error and standard deviation between the predicted sample coordinates and the corresponding ground truth coordinates were found to be 3.33 mm and 2.20 mm respectively.

  3. Increased physical activity improves sleep and mood outcomes in inactive people with insomnia: a randomized controlled trial.

    PubMed

    Hartescu, Iuliana; Morgan, Kevin; Stevinson, Clare D

    2015-10-01

    While high levels of activity and exercise training have been associated with improvements in sleep quality, minimum levels of activity likely to improve sleep outcomes have not been explored. A two-armed parallel randomized controlled trial (N=41; 30 females) was designed to assess whether increasing physical activity to the level recommended in public health guidelines can improve sleep quality among inactive adults meeting research diagnostic criteria for insomnia. The intervention consisted of a monitored program of ≥150 min of moderate- to vigorous-intensity physical activity per week, for 6 months. The principal end-point was the Insomnia Severity Index at 6 months post-baseline. Secondary outcomes included measures of mood, fatigue and daytime sleepiness. Activity and light exposure were monitored throughout the trial using accelerometry and actigraphy. At 6 months post-baseline, the physical activity group showed significantly reduced insomnia symptom severity (F(8,26) = 5.16, P = 0.03), with an average reduction of four points on the Insomnia Severity Index; and significantly reduced depression and anxiety scores (F(6,28) = 5.61, P = 0.02; and F(6,28) = 4.41, P = 0.05, respectively). All of the changes were independent of daily light exposure. Daytime fatigue showed no significant effect of the intervention (F(8,26) = 1.84, P = 0.18). Adherence and retention were high. Internationally recommended minimum levels of physical activity improve daytime and night-time symptoms of chronic insomnia independent of daily light exposure levels.

  4. Registration of interferometric SAR images

    NASA Technical Reports Server (NTRS)

    Lin, Qian; Vesecky, John F.; Zebker, Howard A.

    1992-01-01

    Interferometric synthetic aperture radar (INSAR) is a new way of performing topography mapping. Among the factors critical to mapping accuracy is the registration of the complex SAR images from repeated orbits. A new algorithm for registering interferometric SAR images is presented. A new figure of merit, the average fluctuation function of the phase difference image, is proposed to evaluate the fringe pattern quality. The process of adjusting the registration parameters according to the fringe pattern quality is optimized through a downhill simplex minimization algorithm. The results of applying the proposed algorithm to register two pairs of Seasat SAR images with a short baseline (75 m) and a long baseline (500 m) are shown. It is found that the average fluctuation function is a very stable measure of fringe pattern quality allowing very accurate registration.

  5. [Start of TB case-registration and case-management system in Japan].

    PubMed

    Shimao, Tadao

    2010-07-01

    TB control in Japan started in 1951 through legislation of TB Control Law, consisting of three major components; mass health examination, vaccination and promotion of adequate methods of treatment for TB cases. Mass health examination was first targeted for younger generation below 30 years of age as it was believed that TB was highly prevalent among them, however, it was expanded to cover whole population based on the results of TB Prevalence Survey in 1953 revealing high prevalence of TB in all age groups except children and low awareness of TB cases. Methods of treatment for TB were developing rapidly in late 1950s and early 1960s; initially artificial pneumothorax, then surgical collapse treatment such as thoracoplasty, then pulmonary resection, and finally long term combined use of INH, SM and PAS. Up to surgical treatment era, most TB patients earnestly followed doctor's instruction, however, in chemotherapy era, as most symptoms improved rapidly after the initiation of chemotherapy, patients felt as if they were cured, and it had become difficult to maintain high adherence to treatment. Such behavior was found oftener in patients detected in early stage through mass health examinations. 1947, it was legislated for all doctors to report all diagnosed TB cases to an adjacent health center, and the cases are registered at the health center covering his (her) residence, however, standardized formula of registration was not indicated. In accordance with the progress of TB control program, the number of TB registered cases increased, and the need for standardized registration and case-management had become apparent in mid 1950s, and some preliminary trials had been done. In response to this request, the Ministry of Health and Welfare organized a research group headed by Dr. Misonou K, and the staffs of prefectural health department and enthusiastic staffs working in health centers (HCs), staffs of NIPH (National Institute of Public Health) and RIT (Research

  6. A pilot study examining functional brain activity 6 months after memory retraining in MS: the MEMREHAB trial.

    PubMed

    Dobryakova, Ekaterina; Wylie, Glenn R; DeLuca, John; Chiaravalloti, Nancy D

    2014-09-01

    Cognitive impairment in individuals with multiple sclerosis (MS) is now well recognized. One of the most common cognitive deficits is found in memory functioning, largely due to impaired acquisition. We examined functional brain activity 6 months after memory retraining in individuals with MS. The current report presents long term follow-up results from a randomized clinical trial on a memory rehabilitation protocol known as the modified Story Memory Technique. Behavioral memory performance and brain activity of all participants were evaluated at baseline, immediately after treatment, and 6 months after treatment. Results revealed that previously observed increases in patterns of cerebral activation during learning immediately after memory training were maintained 6 months post training.

  7. 78 FR 58318 - Clinical Trial Design for Intravenous Fat Emulsion Products; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ... HUMAN SERVICES Food and Drug Administration Clinical Trial Design for Intravenous Fat Emulsion Products... ``Clinical Trial Design for Intravenous Fat Emulsion Products.'' This workshop will provide a forum to discuss trial design of clinical trials intended to support registration of intravenous fat...

  8. Semi-automatic elastic registration on thyroid gland ultrasonic image

    NASA Astrophysics Data System (ADS)

    Xu, Xia; Zhong, Yue; Luo, Yan; Li, Deyu; Lin, Jiangli; Wang, Tianfu

    2007-12-01

    Knowledge of in vivo thyroid volume has both diagnostic and therapeutic importance and could lead to a more precise quantification of absolute activity contained in the thyroid gland. However, the shape of thyroid gland is irregular and difficult to calculate. For precise estimation of thyroid volume by ultrasound imaging, this paper presents a novel semiautomatic minutiae matching method in thyroid gland ultrasonic image by means of thin-plate spline model. Registration consists of four basic steps: feature detection, feature matching, mapping function design, and image transformation and resampling. Due to the connectivity of thyroid gland boundary, we choose active contour model as feature detector, and radials from centric points for feature matching. The proposed approach has been used in thyroid gland ultrasound images registration. Registration results of 18 healthy adults' thyroid gland ultrasound images show this method consumes less time and energy with good objectivity than algorithms selecting landmarks manually.

  9. Focus Meetings for Pesticide Registration Review

    EPA Pesticide Factsheets

    Focus meetings with affected registrants and possibly other stakeholders are based around the information needs identified by the EPA chemical review team and management for consideration during our registration reevaluation of a pesticide.

  10. Registration of video sequences from multiple sensors

    NASA Technical Reports Server (NTRS)

    Sharma, Ravi K.; Pavel, Misha

    1997-01-01

    In this paper, we describe an approach for registration of video sequences from a suite of multiple sensors including television, infrared and radar. Video sequences generated by these sensors may contain abrupt changes in local contrast and inconsistent image features, which pose additional difficulties for registration. Our approach to registration addresses the difficulties caused by using multiple sensors. We use a representation for registration that is invariant to local contrast changes, followed by smoothing of the resulting error measure used for registration, for robust estimation of registration parameters. We use an iterative procedure to reduce the effect of inconsistent features. Finally, we describe a method that uses same-sensor registration to aide in performing registration of sequences of video frames across multiple sensors.

  11. 75 FR 19388 - Pesticide Product; Registration Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Pesticide Product; Registration Application AGENCY: Environmental Protection Agency (EPA). ACTION... deadline identified. II. Registration Applications EPA has received an application to register a...

  12. Fuels Registration, Reporting, and Compliance Help

    EPA Pesticide Factsheets

    Information about the requirements for registration and health effects testing of new fuels or fuel additives and mandatory registration for fuels reporting and about mandatory reporting forms for parties regulated under EPA fuel programs.

  13. Brain Connectivity Predicts Placebo Response across Chronic Pain Clinical Trials

    PubMed Central

    Tétreault, Pascal; Mansour, Ali; Vachon-Presseau, Etienne; Schnitzer, Thomas J.; Apkarian, A. Vania

    2016-01-01

    Placebo response in the clinical trial setting is poorly understood and alleged to be driven by statistical confounds, and its biological underpinnings are questioned. Here we identified and validated that clinical placebo response is predictable from resting-state functional magnetic-resonance-imaging (fMRI) brain connectivity. This also led to discovering a brain region predicting active drug response and demonstrating the adverse effect of active drug interfering with placebo analgesia. Chronic knee osteoarthritis (OA) pain patients (n = 56) underwent pretreatment brain scans in two clinical trials. Study 1 (n = 17) was a 2-wk single-blinded placebo pill trial. Study 2 (n = 39) was a 3-mo double-blinded randomized trial comparing placebo pill to duloxetine. Study 3, which was conducted in additional knee OA pain patients (n = 42), was observational. fMRI-derived brain connectivity maps in study 1 were contrasted between placebo responders and nonresponders and compared to healthy controls (n = 20). Study 2 validated the primary biomarker and identified a brain region predicting drug response. In both studies, approximately half of the participants exhibited analgesia with placebo treatment. In study 1, right midfrontal gyrus connectivity best identified placebo responders. In study 2, the same measure identified placebo responders (95% correct) and predicted the magnitude of placebo’s effectiveness. By subtracting away linearly modeled placebo analgesia from duloxetine response, we uncovered in 6/19 participants a tendency of duloxetine enhancing predicted placebo response, while in another 6/19, we uncovered a tendency for duloxetine to diminish it. Moreover, the approach led to discovering that right parahippocampus gyrus connectivity predicts drug analgesia after correcting for modeled placebo-related analgesia. Our evidence is consistent with clinical placebo response having biological underpinnings and shows that the method can also reveal that active

  14. 14 CFR 47.3 - Registration required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Registration required. 47.3 Section 47.3... REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103 only... eligible for registration under 49 U.S.C. 44101-44104, unless the aircraft— (1) Has been registered by...

  15. 14 CFR 47.3 - Registration required.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Registration required. 47.3 Section 47.3... REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103 only... person may operate an aircraft that is eligible for registration under 49 U.S.C. 44101-44104, unless...

  16. 14 CFR 47.3 - Registration required.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Registration required. 47.3 Section 47.3... REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103 only... person may operate an aircraft that is eligible for registration under 49 U.S.C. 44101-44104, unless...

  17. 14 CFR 47.3 - Registration required.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Registration required. 47.3 Section 47.3... REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103 only... person may operate an aircraft that is eligible for registration under 49 U.S.C. 44101-44104, unless...

  18. Living Well with Diabetes: a randomized controlled trial of a telephone-delivered intervention for maintenance of weight loss, physical activity and glycaemic control in adults with type 2 diabetes

    PubMed Central

    2010-01-01

    Background By 2025, it is estimated that approximately 1.8 million Australian adults (approximately 8.4% of the adult population) will have diabetes, with the majority having type 2 diabetes. Weight management via improved physical activity and diet is the cornerstone of type 2 diabetes management. However, the majority of weight loss trials in diabetes have evaluated short-term, intensive clinic-based interventions that, while producing short-term outcomes, have failed to address issues of maintenance and broad population reach. Telephone-delivered interventions have the potential to address these gaps. Methods/Design Using a two-arm randomised controlled design, this study will evaluate an 18-month, telephone-delivered, behavioural weight loss intervention focussing on physical activity, diet and behavioural therapy, versus usual care, with follow-up at 24 months. Three-hundred adult participants, aged 20-75 years, with type 2 diabetes, will be recruited from 10 general practices via electronic medical records search. The Social-Cognitive Theory driven intervention involves a six-month intensive phase (4 weekly calls and 11 fortnightly calls) and a 12-month maintenance phase (one call per month). Primary outcomes, assessed at 6, 18 and 24 months, are: weight loss, physical activity, and glycaemic control (HbA1c), with weight loss and physical activity also measured at 12 months. Incremental cost-effectiveness will also be examined. Study recruitment began in February 2009, with final data collection expected by February 2013. Discussion This is the first study to evaluate the telephone as the primary method of delivering a behavioural weight loss intervention in type 2 diabetes. The evaluation of maintenance outcomes (6 months following the end of intervention), the use of accelerometers to objectively measure physical activity, and the inclusion of a cost-effectiveness analysis will advance the science of broad reach approaches to weight control and health

  19. 75 FR 56101 - Lauryl Sulfate Salts Registration Review Final Decision; Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-15

    ... final registration review decision for the pesticide, lauryl sulfate salts (also known as sodium lauryl... announces the availability of EPA's final registration review decision for the lauryl sulfate salts. Sodium... product that contains sodium lauryl sulfate as an active ingredient. The product, Kleenex Brand...

  20. Multiple Kernel Point Set Registration.

    PubMed

    Nguyen, Thanh Minh; Wu, Q M Jonathan

    2015-12-22

    The finite Gaussian mixture model with kernel correlation is a flexible tool that has recently received attention for point set registration. While there are many algorithms for point set registration presented in the literature, an important issue arising from these studies concerns the mapping of data with nonlinear relationships and the ability to select a suitable kernel. Kernel selection is crucial for effective point set registration. We focus here on multiple kernel point set registration. We make several contributions in this paper. First, each observation is modeled using the Student's t-distribution, which is heavily tailed and more robust than the Gaussian distribution. Second, by automatically adjusting the kernel weights, the proposed method allows us to prune the ineffective kernels. This makes the choice of kernels less crucial. After parameter learning, the kernel saliencies of the irrelevant kernels go to zero. Thus, the choice of kernels is less crucial and it is easy to include other kinds of kernels. Finally, we show empirically that our model outperforms state-of-the-art methods recently proposed in the literature.

  1. Multiple Kernel Point Set Registration.

    PubMed

    Nguyen, Thanh Minh; Wu, Q M Jonathan

    2016-06-01

    The finite Gaussian mixture model with kernel correlation is a flexible tool that has recently received attention for point set registration. While there are many algorithms for point set registration presented in the literature, an important issue arising from these studies concerns the mapping of data with nonlinear relationships and the ability to select a suitable kernel. Kernel selection is crucial for effective point set registration. We focus here on multiple kernel point set registration. We make several contributions in this paper. First, each observation is modeled using the Student's t-distribution, which is heavily tailed and more robust than the Gaussian distribution. Second, by automatically adjusting the kernel weights, the proposed method allows us to prune the ineffective kernels. This makes the choice of kernels less crucial. After parameter learning, the kernel saliencies of the irrelevant kernels go to zero. Thus, the choice of kernels is less crucial and it is easy to include other kinds of kernels. Finally, we show empirically that our model outperforms state-of-the-art methods recently proposed in the literature.

  2. USDA registration and rectification requirements

    NASA Technical Reports Server (NTRS)

    Allen, R.

    1982-01-01

    Some of the requirements of the United States Department of Agriculture for accuracy of aerospace acquired data, and specifically, requirements for registration and rectification of remotely sensed data are discussed. Particular attention is given to foreign and domestic crop estimation and forecasting, forestry information applications, and rangeland condition evaluations.

  3. 75 FR 58292 - Re-Registration and Renewal of Aircraft Registration; OMB Approval of Information Collection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... Federal Aviation Administration 14 CFR Part 47 RIN 2120-AI89 Re-Registration and Renewal of Aircraft... requirements contained in the ``Re-Registration and Renewal of Aircraft Registration'' final rule. The final.... SUPPLEMENTARY INFORMATION: Background On July 20, 2010, the FAA published the final rule ``Re- Registration...

  4. 49 CFR 368.5 - Re-registration of certain carriers holding certificates of registration.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Re-registration of certain carriers holding certificates of registration. 368.5 Section 368.5 Transportation Other Regulations Relating to Transportation... MUNICIPALITIES. § 368.5 Re-registration of certain carriers holding certificates of registration. (a) Each...

  5. 21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number....

  6. 21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number....

  7. 21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number....

  8. 21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number....

  9. 21 CFR 710.6 - Notification of registrant; cosmetic product establishment registration number.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Notification of registrant; cosmetic product... OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.6 Notification of registrant; cosmetic product establishment registration number....

  10. 16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of...

  11. 16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of...

  12. 16 CFR 1130.7 - Requirements for Web site registration or alternative e-mail registration.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.7 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of...

  13. 16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Requirements for Web site registration or... PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for the purpose of...

  14. 16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Requirements for Web site registration or... PRODUCTS (Eff. June 28, 2010) § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to registration page. The manufacturer's Web site, or other Web site established for...

  15. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Registration number. 47.15 Section 47.15 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft...

  16. 14 CFR 47.3 - Registration required.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Registration required. 47.3 Section 47.3 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION General § 47.3 Registration required. (a) An aircraft may be registered under 49 U.S.C. 44103...

  17. 29 CFR 500.145 - Registration determinations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 3 2010-07-01 2010-07-01 false Registration determinations. 500.145 Section 500.145 Labor... SEASONAL AGRICULTURAL WORKER PROTECTION Enforcement § 500.145 Registration determinations. Section 500.51... revoke, a Certificate of Registration (including a Farm Labor Contractor Employee Certificate...

  18. 17 CFR 48.3 - Registration required.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 17 Commodity and Securities Exchanges 1 2012-04-01 2012-04-01 false Registration required. 48.3 Section 48.3 Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION REGISTRATION OF FOREIGN BOARDS OF TRADE § 48.3 Registration required. (a) Except as specified in this part, it shall...

  19. 14 CFR 380.62 - Registration applications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Registration applications. 380.62 Section... PROCEEDINGS) SPECIAL REGULATIONS PUBLIC CHARTERS Registration of Foreign Charter Operators § 380.62 Registration applications. (a) To be registered under this subpart, a foreign charter operator shall file...

  20. 27 CFR 26.171 - Claimant registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Claimant registration. 26... Drawback on Eligible Articles From Puerto Rico § 26.171 Claimant registration. Any person filing claim for... as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  1. 46 CFR 389.3 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 8 2012-10-01 2012-10-01 false Registration. 389.3 Section 389.3 Shipping MARITIME... VESSELS FOR TRANSPORTATION OF PLATFORM JACKETS § 389.3 Registration. In order to provide timely... notification as outlined in this section. (a) Registration of coastwise-qualified vessel for platform...

  2. 29 CFR 500.145 - Registration determinations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 3 2014-07-01 2014-07-01 false Registration determinations. 500.145 Section 500.145 Labor... SEASONAL AGRICULTURAL WORKER PROTECTION Enforcement § 500.145 Registration determinations. Section 500.51... revoke, a Certificate of Registration (including a Farm Labor Contractor Employee Certificate...

  3. 32 CFR 935.150 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 6 2014-07-01 2014-07-01 false Registration. 935.150 Section 935.150 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE TERRITORIAL AND INSULAR REGULATIONS WAKE ISLAND CODE Registration and Island Permits § 935.150 Registration. (a) Each person who...

  4. 7 CFR 1219.102 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Registration. 1219.102 Section 1219.102 Agriculture..., AND INFORMATION Referendum Procedures § 1219.102 Registration. An eligible producer or importer of... referendum under § 1219.104(b). Registration information shall be confidential under § 1219.108....

  5. 5 CFR 330.207 - Registration area.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 1 2013-01-01 2013-01-01 false Registration area. 330.207 Section 330..., SELECTION, AND PLACEMENT (GENERAL) Reemployment Priority List (RPL) § 330.207 Registration area. (a) Except as provided in paragraphs (b) through (e) of this section, RPL registration is limited to the...

  6. 32 CFR 1615.3 - Registration procedures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Registration procedures. 1615.3 Section 1615.3 National Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF REGISTRATION § 1615.3 Registration procedures. Persons required by selective service law and the...

  7. 18 CFR 390.1 - Electronic registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Electronic registration. 390.1 Section 390.1 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY PROCEDURAL RULES ELECTRONIC REGISTRATION § 390.1 Electronic registration. Any person...

  8. 17 CFR 48.5 - Registration procedures.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 17 Commodity and Securities Exchanges 1 2012-04-01 2012-04-01 false Registration procedures. 48.5 Section 48.5 Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION REGISTRATION OF FOREIGN BOARDS OF TRADE § 48.5 Registration procedures. (a) A foreign board of trade seeking...

  9. 22 CFR 122.1 - Registration requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Registration requirements. 122.1 Section 122.1 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS REGISTRATION OF MANUFACTURERS AND EXPORTERS § 122.1 Registration requirements. (a) Any person who engages in the United...

  10. 40 CFR 68.160 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 16 2013-07-01 2013-07-01 false Registration. 68.160 Section 68.160... ACCIDENT PREVENTION PROVISIONS Risk Management Plan § 68.160 Registration. (a) The owner or operator shall complete a single registration form and include it in the RMP. The form shall cover all...

  11. 47 CFR 64.1195 - Registration requirement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 3 2012-10-01 2012-10-01 false Registration requirement. 64.1195 Section 64....1195 Registration requirement. (a) Applicability. A telecommunications carrier that will provide interstate telecommunications service shall file the registration information described in paragraph (b)...

  12. 14 CFR 380.62 - Registration applications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Registration applications. 380.62 Section... PROCEEDINGS) SPECIAL REGULATIONS PUBLIC CHARTERS Registration of Foreign Charter Operators § 380.62 Registration applications. (a) To be registered under this subpart, a foreign charter operator shall file...

  13. 8 CFR 1244.17 - Annual registration.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 8 Aliens and Nationality 1 2011-01-01 2011-01-01 false Annual registration. 1244.17 Section 1244... REGULATIONS TEMPORARY PROTECTED STATUS FOR NATIONALS OF DESIGNATED STATES § 1244.17 Annual registration. (a... jurisdiction over their place of residence. Such registration will apply to nationals of those foreign...

  14. 31 CFR 346.2 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance: Treasury 2 2014-07-01 2014-07-01 false Registration. 346.2 Section 346.2 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) FISCAL SERVICE... RETIREMENT BONDS § 346.2 Registration. (a) General. The registration of Individual Retirement Bonds...

  15. 32 CFR 935.150 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 6 2011-07-01 2011-07-01 false Registration. 935.150 Section 935.150 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE TERRITORIAL AND INSULAR REGULATIONS WAKE ISLAND CODE Registration and Island Permits § 935.150 Registration. (a) Each person who...

  16. 18 CFR 390.1 - Electronic registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Electronic registration. 390.1 Section 390.1 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY PROCEDURAL RULES ELECTRONIC REGISTRATION § 390.1 Electronic registration. Any person...

  17. 14 CFR 380.62 - Registration applications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Registration applications. 380.62 Section... PROCEEDINGS) SPECIAL REGULATIONS PUBLIC CHARTERS Registration of Foreign Charter Operators § 380.62 Registration applications. (a) To be registered under this subpart, a foreign charter operator shall file...

  18. 9 CFR 320.5 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Registration. 320.5 Section 320.5... CERTIFICATION RECORDS, REGISTRATION, AND REPORTS § 320.5 Registration. (a) Except as provided in paragraph (c... therein upon said effective date. All information submitted shall be current and correct. The...

  19. 7 CFR 1219.102 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 10 2014-01-01 2014-01-01 false Registration. 1219.102 Section 1219.102 Agriculture..., AND INFORMATION Referendum Procedures § 1219.102 Registration. An eligible producer or importer of... referendum under § 1219.104(b). Registration information shall be confidential under § 1219.108....

  20. 46 CFR 389.3 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 8 2013-10-01 2013-10-01 false Registration. 389.3 Section 389.3 Shipping MARITIME... VESSELS FOR TRANSPORTATION OF PLATFORM JACKETS § 389.3 Registration. In order to provide timely... notification as outlined in this section. (a) Registration of coastwise-qualified vessel for platform...

  1. 27 CFR 24.52 - Dealer registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Dealer registration. 24.52... OF THE TREASURY LIQUORS WINE Administrative and Miscellaneous Provisions Dealer Registration and Recordkeeping § 24.52 Dealer registration. Every proprietor who sells or offers for sale any alcohol...

  2. 27 CFR 19.202 - Dealer registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Dealer registration. 19..., DEPARTMENT OF THE TREASURY LIQUORS DISTILLED SPIRITS PLANTS Dealer Registration and Recordkeeping § 19.202 Dealer registration. Every proprietor that sells or offers for sale any alcoholic product...

  3. 25 CFR 81.11 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 1 2011-04-01 2011-04-01 false Registration. 81.11 Section 81.11 Indians BUREAU OF... STATUTE § 81.11 Registration. (a) Only registered voters will be entitled to vote, and all determinations... member not residing on the reservation shall be accompanied by a preaddressed registration form (BIA...

  4. 8 CFR 244.17 - Annual registration.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 8 Aliens and Nationality 1 2011-01-01 2011-01-01 false Annual registration. 244.17 Section 244.17... FOR NATIONALS OF DESIGNATED STATES § 244.17 Annual registration. (a) Aliens granted Temporary... of residence. Such registration will apply to nationals of those foreign states designated...

  5. 29 CFR 500.145 - Registration determinations.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 3 2012-07-01 2012-07-01 false Registration determinations. 500.145 Section 500.145 Labor... SEASONAL AGRICULTURAL WORKER PROTECTION Enforcement § 500.145 Registration determinations. Section 500.51... revoke, a Certificate of Registration (including a Farm Labor Contractor Employee Certificate...

  6. 8 CFR 1244.17 - Annual registration.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Annual registration. 1244.17 Section 1244... REGULATIONS TEMPORARY PROTECTED STATUS FOR NATIONALS OF DESIGNATED STATES § 1244.17 Annual registration. (a... jurisdiction over their place of residence. Such registration will apply to nationals of those foreign...

  7. 27 CFR 447.31 - Registration requirement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Registration requirement. 447.31 Section 447.31 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS... IMPLEMENTS OF WAR Registration § 447.31 Registration requirement. Persons engaged in the business, in...

  8. 25 CFR 81.11 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 1 2012-04-01 2011-04-01 true Registration. 81.11 Section 81.11 Indians BUREAU OF INDIAN....11 Registration. (a) Only registered voters will be entitled to vote, and all determinations of the... residing on the reservation shall be accompanied by a preaddressed registration form (BIA Form 8302)...

  9. 31 CFR 346.2 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 2 2012-07-01 2012-07-01 false Registration. 346.2 Section 346.2 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) FISCAL SERVICE... RETIREMENT BONDS § 346.2 Registration. (a) General. The registration of Individual Retirement Bonds...

  10. 32 CFR 1615.3 - Registration procedures.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 6 2012-07-01 2012-07-01 false Registration procedures. 1615.3 Section 1615.3 National Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF REGISTRATION § 1615.3 Registration procedures. Persons required by selective service law and the...

  11. 22 CFR 122.3 - Registration fees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Registration fees. 122.3 Section 122.3 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS REGISTRATION OF MANUFACTURERS AND EXPORTERS § 122.3 Registration fees. (a) A person who is required to register must do so on an annual...

  12. 27 CFR 26.307 - Claimant registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Claimant registration. 26... Drawback on Eligible Articles From the Virgin Islands § 26.307 Claimant registration. Any person filing... must register annually as a nonbeverage domestic drawback claimant. Registration will be...

  13. 27 CFR 447.31 - Registration requirement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Registration requirement. 447.31 Section 447.31 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS... IMPLEMENTS OF WAR Registration § 447.31 Registration requirement. Persons engaged in the business, in...

  14. 22 CFR 122.3 - Registration fees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Registration fees. 122.3 Section 122.3 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS REGISTRATION OF MANUFACTURERS AND EXPORTERS § 122.3 Registration fees. (a) A person who is required to register must do so on an annual...

  15. 27 CFR 26.307 - Claimant registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Claimant registration. 26... Drawback on Eligible Articles From the Virgin Islands § 26.307 Claimant registration. Any person filing... must register annually as a nonbeverage domestic drawback claimant. Registration will be...

  16. 32 CFR 636.9 - Registration requirement.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 4 2013-07-01 2013-07-01 false Registration requirement. 636.9 Section 636.9... § 636.9 Registration requirement. In addition to the requirements of § 634.20 of this subchapter: (a... insurance will be required at the time of registration. (e) Vehicle safety inspections are not required...

  17. 27 CFR 26.171 - Claimant registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Claimant registration. 26... Drawback on Eligible Articles From Puerto Rico § 26.171 Claimant registration. Any person filing claim for... as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  18. 49 CFR 107.503 - Registration statement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 2 2012-10-01 2012-10-01 false Registration statement. 107.503 Section 107.503... PROGRAM PROCEDURES Registration of Cargo Tank and Cargo Tank Motor Vehicle Manufacturers, Assemblers, Repairers, Inspectors, Testers, and Design Certifying Engineers § 107.503 Registration statement. (a)...

  19. 40 CFR 68.160 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 15 2011-07-01 2011-07-01 false Registration. 68.160 Section 68.160... ACCIDENT PREVENTION PROVISIONS Risk Management Plan § 68.160 Registration. (a) The owner or operator shall complete a single registration form and include it in the RMP. The form shall cover all...

  20. 5 CFR 330.207 - Registration area.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Registration area. 330.207 Section 330..., SELECTION, AND PLACEMENT (GENERAL) Reemployment Priority List (RPL) § 330.207 Registration area. (a) Except as provided in paragraphs (b) through (e) of this section, RPL registration is limited to the...