Science.gov

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. [A review of international clinical trial registration].

    PubMed

    Yu, He; Liu, Jian-ping

    2007-05-01

    Clinical trials play a critical role in medical research. However, only a few clinical trials conducted at present have been registered at various clinical trial registries. Clinical trial registration can prevent bias in these registered trials effectively and avoid unnecessary waste of resources due to meaningless repeats. Moreover, it will benefit the development of evidence-based medicine, and promote human welfare. Great attention has been paid to the importance and necessity of clinical trial registration. This review briefly introduced the definition, justification, contents, history, current status of clinical trial registration, and introduced the information regarding important international clinical trial registries in detail. Clinical trial registration should be developed toward a transparent, compulsory and comprehensive stage. PMID:17498477

  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. 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.

  5. 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. PMID:27658315

  6. Trials and Tribulations: An Industry Perspective on Conducting Registrational Trials in Alpha-1 Antitrypsin Deficiency.

    PubMed

    Forshag, Mark S

    2016-08-01

    Registrational trials in rare and orphan diseases present complexities related to the identification of subjects, recruitment, logistical hurdles incumbent with far-flung study sites, and end points that are often less well defined than are those used in more common illnesses. Alpha-1 antitrypsin deficiency is an orphan disease of genetic origin that carries the additional challenges of variable penetration and slow disease progression. Registrational trials of augmentation therapy using plasma-derived alpha-1 antitrypsin carry all of the above-noted burdens, as well as competition from commercially available augmentation therapy in many countries. PMID:27564675

  7. Clinical trial registration in physiotherapy journals: recommendations from the International Society of Physiotherapy Journal Editors.

    PubMed

    Costa, Leonardo O P; Lin, Chung-Wei Christine; Grossi, Debora Bevilaqua; Mancini, Marisa Cota; Swisher, Anne K; Cook, Chad E; Vaughn, Daniel W; Elkins, Mark R; Sheikh, Umer; Moore, Ann; Jull, Gwendolen A; Craik, Rebecca L; Maher, Christopher G; Guirro, Rinaldo Roberto de Jesus; Marques, Amélia Pasqual; Harms, Michele; Brooks, Dina; Simoneau, Guy G; Strupstad, John Henry

    2012-12-01

    Clinical trial registration involves placing the protocol for a clinical trial on a free, publicly available, and electronically searchable register. Registration is considered to be prospective if the protocol is registered before the trial commences (ie, before the first participant is enrolled). Prospective registration has several potential advantages. It could help avoid trials being duplicated unnecessarily and it could allow people with health problems to identify trials in which they might participate. Perhaps more importantly, however, it tackles 2 big problems in clinical research: selective reporting and publication bias. Prospective clinical trial registration is of great potential value to the clinicians, consumers, and researchers who rely on clinical trial data, and that is why the International Society of Physiotherapy Journal Editors (ISPJE) is recommending that members enact a policy for prospective trial registration.

  8. 18 CFR 390.2 - Activities requiring registration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Activities requiring 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...

  9. Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals.

    PubMed

    Reveiz, Ludovic; Villanueva, Eleana; Iko, Chimaraoke; Simera, Iveta

    2013-06-01

    The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and CONSORT guidance was mentioned. Information regarding endorsement of the ICMJE, trial registration and other reporting guidelines was extracted from the online instructions for authors of the journals included in the study. The search identified 477 references. We assessed a random sample of 240 titles of which 101 were randomized clinical trials published in 56 journals. Trial registration was reported in 19.8% of the randomized clinical trials, 6.9% were prospectively registered and 3% mentioned CONSORT. The ICMJE was mentioned by 68% of the journals and 36% of journals required trial registration. Fewer journals provided advice on reporting guidelines: CONSORT (13%), PRISMA (1.8%), STROBE (1.8%), and the EQUATOR network (3.6%). Wider endorsement of trial registration and adherence to reporting guidelines is necessary in clinical trials conducted in Latin America and the Caribbean.

  10. 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

  11. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

    PubMed Central

    Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

    2015-01-01

    Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis

  12. Registration of all rehabilitation clinical trials: an ethical and editorial imperative.

    PubMed

    Wade, Derick

    2016-03-01

    Registration of randomized controlled trials is essential to reduce the risk of biased data being used when judging the effectiveness of an intervention. This journal will in future require that all randomized trials submitted are registered on a recognized register. This editorial explains why.

  13. 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

  14. ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study

    PubMed Central

    2013-01-01

    Background The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. Methods We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. Results We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the “Primary Outcome” field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials

  15. 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

  16. 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. PMID:24231337

  17. Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform.

    PubMed

    Gu, Jing; Wang, Qi; Wang, Xiaogang; Li, Hailong; Gu, Mei; Ming, Haixia; Dong, Xiaoli; Yang, Kehu; Wu, Hongyan

    2014-01-01

    Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration.

  18. 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

  19. 75 FR 6386 - Pesticide Products; Registration Applications for a New Active Ingredient Chemical; Demiditraz

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

    ... register pesticide products containing active ingredients not included in any previously registered pesticide products. Pursuant to the provisions of section 3(c)(4) of the Federal Insecticide, Fungicide, and... AGENCY Pesticide Products; Registration Applications for a New Active Ingredient Chemical;...

  20. 78 FR 10167 - Pesticide Products; Registration Applications for a New Active Ingredient

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... include: Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS... AGENCY Pesticide Products; Registration Applications for a New Active Ingredient AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has received applications to register...

  1. 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...

  2. 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...

  3. A trial linkage of the road accident and vehicle registration files.

    PubMed

    Lindeijer, J E

    1987-04-01

    Vehicle characteristics are of importance in all phases of road accident. None, however, are recorded by the police on the road accident registration form in The Netherlands. By linking the Vehicle Registration file to the Road Accident file a number of important vehicle characteristics can be added to the accident record. Theoretically it had to be possible to link both files because there was a common key variable viz. the vehicle registration number, which in The Netherlands is unique and stays with the vehicle its whole life. The test linkage was aimed at determining whether it was also practically possible. It was furthermore aimed at determining the completeness and reliability of both files. The fatal accidents of 1981 were selected to serve for the test because only fatal accidents are completely recorded, and 1981 was the most recent available year at the time. These limitations made it possible for SWOV to carry out a manual control on vehicle make and model, as this is often recorded by the police. Based on the conformity found, the validity of the linking by vehicle registration number was found to be 94% and the reliability at least 95%. The conclusion is therefore that the linkage can be accomplished in practice and that it reliably adds useful vehicle characteristics to the police records on fatal road accidents. This complementary information is in the first place important for deeper analysis of the relationship between, on the one hand, accident and injury characteristics and, on the other hand, the vehicle characteristics.

  4. [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.

  5. 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

  6. 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…

  7. 21 CFR 1301.11 - Persons required to register; requirement of modification of registration authorizing activity as...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Persons required to register; requirement of 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...

  8. 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

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Persons required to register; requirement of 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...

  9. 21 CFR 1301.11 - Persons required to register; requirement of modification of registration authorizing activity as...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Persons required to register; requirement of 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...

  10. 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...

  11. 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...

  12. 21 CFR 1309.24 - Waiver of registration requirement for certain activities.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Waiver of registration requirement for certain activities. 1309.24 Section 1309.24 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE... must comply with the security requirements set forth in §§ 1309.71 through 1309.73 and...

  13. 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.

  14. 78 FR 67395 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Registration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ...File system in operation since March 1, 2011, permits registrants to file their registration forms electronically to the FARA Registration Unit, 24 hours a day, seven days a week. FARA eFile is accessed via...

  15. 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

  16. 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

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

    2016-03-01

    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.

  17. 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

  18. Ten Years after the International Committee of Medical Journal Editors’ Clinical Trial Registration Initiative, One Quarter of Phase 3 Pediatric Epilepsy Clinical Trials Still Remain Unpublished: A Cross Sectional Analysis

    PubMed Central

    Lampert, Anette; Hoffmann, Georg F.; Ries, Markus

    2016-01-01

    Introduction Although selective reporting of clinical trial results introduces bias into evidence based clinical decision making, publication bias in pediatric epilepsy is unknown today. Since there is a considerable ambiguity in the treatment of an important and common clinical problem, pediatric seizures, we assessed the public availability of results of phase 3 clinical trials that evaluated treatments of seizures in children and adolescents as a surrogate for the extent of publication bias in pediatric epilepsy. Methods We determined the proportion of published and unpublished study results of phase 3 clinical trials that were registered as completed on ClinicalTrials.gov. We searched ClinicalTrials.gov, PubMed, and Google Scholar for publications and contacted principal investigators or sponsors. The analysis was performed according to STROBE criteria. Results Considering studies that were completed before 2014 (N = 99), 75 (76%) pediatric phase 3 clinical trials were published but 24 (24%) remained unpublished. The unpublished studies concealed evidence from 4,437 patients. Mean time-to-publication was 25 SD ± 15.6 months, more than twice as long as mandated. Conclusion Ten years after the ICMJE’s clinical trials registration initiative there is still a considerable amount of selective reporting and delay of publication that potentially distorts the body of evidence in the treatment of pediatric seizures. PMID:26735955

  19. 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

  20. The Infant Feeding Activity and Nutrition Trial (INFANT) an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    PubMed Central

    Campbell, Karen; Hesketh, Kylie; Crawford, David; Salmon, Jo; Ball, Kylie; McCallum, Zoë

    2008-01-01

    , physical activity and reduced sedentary behaviours. If proven to be effective, INFANT may protect children from the development of obesity and its associated social and economic costs. Trial registration Current Controlled Trials ISRCTN81847050 PMID:18373877

  1. 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

  2. Physical Activity Counselling during Pulmonary Rehabilitation in Patients with COPD: A Randomised Controlled Trial

    PubMed Central

    Burtin, Chris; Langer, Daniel; van Remoortel, Hans; Demeyer, Heleen; Gosselink, Rik; Decramer, Marc; Dobbels, Fabienne; Janssens, Wim; Troosters, Thierry

    2015-01-01

    Background Pulmonary rehabilitation programs only modestly enhance daily physical activity levels in patients with chronic obstructive pulmonary disease (COPD). This randomised controlled trial investigates the additional effect of an individual activity counselling program during pulmonary rehabilitation on physical activity levels in patients with moderate to very severe COPD. Methods Eighty patients (66±7 years, 81% male, forced expiratory volume in 1 second 45±16% of predicted) referred for a six‐month multidisciplinary pulmonary rehabilitation program were randomised. The intervention group was offered an additional eight-session activity counselling program. The primary outcomes were daily walking time and time spent in at least moderate intense activities. Results Baseline daily walking time was similar in the intervention and control group (median 33 [interquartile range 16–47] vs 29 [17–44]) whereas daily time spent in at least moderate intensity was somewhat higher in the intervention group (17[4–50] vs 12[2–26] min). No significant intervention*time interaction effects were observed in daily physical activity levels. In the whole group, daily walking time and time spent in at least moderate intense activities did not significantly change over time. Conclusions The present study identified no additional effect of eight individual activity counselling sessions during pulmonary rehabilitation to enhance physical activity levels in patients with COPD. Trial Registration clinicaltrials.gov NCT00948623 PMID:26697853

  3. 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

  4. 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…

  5. 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

  6. 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...

  7. 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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... limited to the distribution of red phosphorus, white phosphorus, or hypophosphorous acid (and its salts... registration is waived for any person whose distribution of red phosphorus or white phosphorus is...

  10. 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... finding of registrability under FIFRA sec. 3(c)(5) if the Agency determines that: (a) Insufficient...

  11. 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... finding of registrability under FIFRA sec. 3(c)(5) if the Agency determines that: (a) Insufficient...

  12. 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... finding of registrability under FIFRA sec. 3(c)(5) if the Agency determines that: (a) Insufficient...

  13. Increasing girls’ physical activity during an organised youth sport basketball program: a randomised controlled trial protocol

    PubMed Central

    2014-01-01

    Background Participation in organised youth sports (OYS) has been recommended as an opportunity to increase young peoples’ moderate-to-vigorous physical activity (MVPA) levels. Participants, however, spend a considerable proportion of time during OYS inactive. The purpose of this study, therefore, was to investigate whether coaches who attended coach education sessions (where education on increasing MVPA and decreasing inactivity during training was delivered) can increase players’ MVPA during training sessions over a 5-day basketball program compared to coaches who did not receive coach education sessions. Methods/design A convenience sample of 80 female players and 8 coaches were recruited into the UWS School Holiday Basketball Program in Greater Western Sydney, Australia. A two-arm, parallel-group randomised controlled trial was employed to investigate whether coaches who attended 2 coach education sessions (compared with a no-treatment control) can increase their players’ MVPA during training sessions over a 5-day basketball program. Objectively measured physical activity, directly observed lesson context and leader behaviour, player motivation, players’ perceived autonomy support, and coaching information (regarding training session planning, estimations on player physical activity and lesson context during training, perceived ability to modify training sessions, perceived importance of physical activity during training, intention to increase physical activity/reduce inactivity, and likelihood of increasing physical activity/reducing inactivity) were assessed at baseline (day 1) and at follow-up (day 5). Linear mixed models will be used to analyse between arm differences in changes from baseline to follow-up on all outcomes. Discussion The current trial protocol describes, to our knowledge, the first trial conducted in an OYS context to investigate the efficacy of an intervention, relative to a control, in increasing MVPA. This study’s findings will

  14. 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

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

    PubMed

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

    2016-02-21

    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. PMID:26854817

  16. 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

  17. 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

  18. Working memory training for adult hearing aid users: study protocol for a double-blind randomized active controlled trial

    PubMed Central

    2013-01-01

    Background One in ten people aged between 55 to 74 years have a significant hearing impairment in their better hearing ear (as defined by audiometric hearing thresholds). However, it is becoming increasingly clear that the challenges faced by older listeners cannot be explained by the audiogram alone. The ability for people with hearing loss to use cognition to support speech perception allows for compensation of the degraded auditory input. This in turn offers promise for new cognitive-based rehabilitative interventions. Working memory is known to be highly associated with language comprehension and recent evidence has shown significant generalization of learning from trained working memory tasks to improvements in sentence-repetition skills of children with severe to profound hearing loss. This evidence offers support for further investigation into the potential benefits of working memory training to improve speech perception abilities in other hearing impaired populations. Methods/Design This is a double-blind randomized active controlled trial aiming to assess whether a program of working memory training results in improvements in untrained measures of cognition, speech perception and self-reported hearing abilities in adult hearing aid users (aged 50 to 74 years) with mild-to-moderate hearing loss, compared with an active control group who receive a placebo version of the working memory training program. Discussion The present study aims to generate high-quality preliminary evidence for the efficacy of working memory training for adults with mild-to-moderate sensorineural hearing loss who are existing hearing aid users. This trial addresses a number of gaps in the published literature assessing training interventions for people with hearing loss, and in the general literature surrounding working memory training, such as the inclusion of an active control group, participant and tester blinding, and increased transparency in reporting. Trial registration

  19. 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.

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

    NASA Astrophysics Data System (ADS)

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

    2015-04-01

    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.

  1. Effect of Selenium Supplementation on Glutathione Peroxidase Enzyme Activity in Patients With Chronic Kidney Disease: A Randomized Clinical Trial

    PubMed Central

    Sedighi, Omid; Zargari, Mehryar; Varshi, Gharmohammad

    2014-01-01

    Background: Plasma selenium (Se) concentration and glutathione peroxidase (GSH-Pxs) enzyme activity of the patients with chronic kidney disease (CKD) are usually lower than healthy individuals; however, the effect of Se supplementation on the GSH-Pxs activity in those patients remains unclear. Objectives: This study aimed to assess the effect of Se supplementation on plasma Se concentration and red blood cell (RBC) GSH-Pxs activity in patients with different stages of CKD. Patients and Methods: In this randomized clinical trial, forty-five patients with CKD who attended in a nephrology clinic were recruited. The patients were randomly allocated into three groups according to their creatinine clearance rate and were supplemented with daily Se 200 mcg for three months. Plasma Se concentration and RBC GSH-Pxs activity were measured in each patient at the beginning and at the end of the study. This clinical trial was registered in the Iranian Registry of Clinical Trials (www.irct.ir) with registration number ID of IRCT201305318501N2. Results: Plasma Se concentration and RBC GSH-Pxs activity increased significantly in all three groups of patients with CKD (P < 0.05). There were no significant differences between three groups regarding baseline plasma Se (P = 0.268) and RBC GSH-Pxs activity (P = 0.741). Conclusions: Se supplementation can increase plasma Se concentration and RBC GSH-Pxs activity in patients with different stages of CKD. PMID:25032143

  2. 31 CFR 545.511 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the Taliban for the purpose of relieving human suffering. Applicants for registration numbers must... applicable U.S. laws governing the exportation or reexportation of U.S.-origin goods, software, or technology.... Department of Commerce (15 CFR parts 730-774)....

  3. 31 CFR 538.521 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... technology to Sudan and the transfer of funds to and from Sudan for the purpose of relieving human suffering. Applicants for registration numbers must comply with the requirements of § 501.801(c), 31 CFR chapter V. (b... reexportation of U.S.-origin goods, software, or technology (including technical data). See, e.g., the...

  4. 31 CFR 538.521 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... technology to Sudan and the transfer of funds to and from Sudan for the purpose of relieving human suffering. Applicants for registration numbers must comply with the requirements of § 501.801(c), 31 CFR chapter V. (b... reexportation of U.S.-origin goods, software, or technology (including technical data). See, e.g., the...

  5. 31 CFR 538.521 - Registration of nongovernmental organizations for humanitarian or religious activities.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... reexportation of U.S.-origin goods, software, or technology (including technical data). See, e.g., the Export Administration Regulations administered by the U.S. Department of Commerce (15 CFR parts 730-774). .... Applicants for registration numbers must comply with the requirements of § 501.801(c), 31 CFR chapter V....

  6. 75 FR 12547 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... United States. ] DATES: Submit written or electronic comments on the collection of information by May 17....gov . Submit written comments on the collection of information to the Division of Dockets Management... registration will, on average, require a burden of approximately 1 hour, taking into account fluency in...

  7. 78 FR 4414 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... United States. DATES: Submit either electronic or written comments on the collection of information by....regulations.gov . Submit written comments on the collection of information to the Division of Dockets... Facility Registrations and Updates to Food Product Categories'' (77 FR 64999, October 24, 2012)...

  8. 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…

  9. [Analysis and discussion on current condition of acupuncture clinical research registration].

    PubMed

    Xu, Ying; Chen, Bo; Guo, Yi

    2015-06-01

    To introduce the international registration condition of acupuncture clinical research. With the examples of World Health Organization International Clinical Trials Registry Platform and the U. S. National Institutes of Health Clinical Registration Platform, the registration method and current condition of acupuncture clinical trials in international clinical trials registration platform were analyzed. The results indicate that the number of acupuncture clinical trials registration is gradually increased and the registration number from China is on the rise as well. But most domestic acupuncture clinical researches haven't been registered arid the researchers' valuing degree for clinical trials registration and methodology research needs to be improved. PMID:26480568

  10. Activity Increase Despite Arthritis (AÏDA): design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946

    PubMed Central

    Williams, Nefyn H; Amoakwa, Elvis; Burton, Kim; Hendry, Maggie; Belcher, John; Lewis, Ruth; Hood, Kerenza; Jones, Jeremy; Bennett, Paul; Edwards, Rhiannon T; Neal, Richard D; Andrew, Glynne; Wilkinson, Clare

    2009-01-01

    Background Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. Methods/Design This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. Discussion We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome

  11. More Active Mums in Stirling (MAMMiS): a physical activity intervention for postnatal women. Study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Many postnatal women are insufficiently physically active in the year after childbirth and could benefit from interventions to increase activity levels. However, there is limited information about the efficacy, feasibility and acceptability of motivational and behavioral interventions promoting postnatal physical activity in the UK. Methods The MAMMiS study is a randomized, controlled trial, conducted within a large National Health Service (NHS) region in Scotland. Up to 76 postnatal women will be recruited to test the impact of two physical activity consultations and a 10-week group pram-walking program on physical activity behavior change. The intervention uses evidence-based motivational and behavioral techniques and will be systematically evaluated using objective measures (accelerometers) at three months, with a maintenance measure taken at a six-month follow-up. Secondary health and well-being measures and psychological mediators of physical activity change are included. Discussion The (MAMMiS study will provide a test of a theoretical and evidence-based physical activity behavior change intervention for postnatal women and provide information to inform future intervention development and testing within this population. Trial registration Current Controlled Trials ISRCTN79011784 PMID:22818406

  12. Average Is Optimal: An Inverted-U Relationship between Trial-to-Trial Brain Activity and Behavioral Performance

    PubMed Central

    He, Biyu J.; Zempel, John M.

    2013-01-01

    It is well known that even under identical task conditions, there is a tremendous amount of trial-to-trial variability in both brain activity and behavioral output. Thus far the vast majority of event-related potential (ERP) studies investigating the relationship between trial-to-trial fluctuations in brain activity and behavioral performance have only tested a monotonic relationship between them. However, it was recently found that across-trial variability can correlate with behavioral performance independent of trial-averaged activity. This finding predicts a U- or inverted-U- shaped relationship between trial-to-trial brain activity and behavioral output, depending on whether larger brain variability is associated with better or worse behavior, respectively. Using a visual stimulus detection task, we provide evidence from human electrocorticography (ECoG) for an inverted-U brain-behavior relationship: When the raw fluctuation in broadband ECoG activity is closer to the across-trial mean, hit rate is higher and reaction times faster. Importantly, we show that this relationship is present not only in the post-stimulus task-evoked brain activity, but also in the pre-stimulus spontaneous brain activity, suggesting anticipatory brain dynamics. Our findings are consistent with the presence of stochastic noise in the brain. They further support attractor network theories, which postulate that the brain settles into a more confined state space under task performance, and proximity to the targeted trajectory is associated with better performance. PMID:24244146

  13. 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

  14. A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol

    PubMed Central

    Holt, Anne-Marie; Jancey, Jonine; Lee, Andy H; Kerr, Deborah A; Hills, Andrew P; Anderson, Annie S; Howat, Peter A

    2014-01-01

    Introduction Physical activity levels of Australia's ageing population are declining and coincidentally rates of overweight and obesity are increasing. Adequate levels of physical activity and a healthy diet are recognised as important lifestyle factors for the maintenance of a healthy weight and prevention of chronic diseases. Retirement village (RV) residents rarely engage in physical activity and nutrition programmes offered, with poor attendance and low use of existing facilities such as on-site fitness centres and classes and nutrition seminars. The RV provides a unique setting to access and engage with this older target group, to test the effectiveness of strategies to increase levels of physical activity, improve nutrition and maintain a healthy weight. Method and analysis This cluster-randomised controlled trial will evaluate a physical activity, nutrition and healthy weight management intervention for insufficiently active (‘not achieving 150 min of moderate-intensity physical activity per week’) adults aged 60–75 residing in RV's. A total of 400 participants will be recruited from 20 randomly selected RV's in Perth, Western Australia. Villages will be assigned to either the intervention group (n=10) or the control group (n=10) each containing 200 participants. The Retirement Village Physical Activity and Nutrition for Seniors (RVPANS) programme is a home-based physical activity and nutrition programme that includes educational resources, along with facilitators who will motivate and guide the participants during the 6-month intervention. Descriptive statistics and mixed regression models will be performed to assess the intervention effects. This trial will evaluate an intervention for the modification of health risk factors in the RV setting. Such research conducted in RV's has been limited. Ethics and dissemination Curtin University Human Research Ethics Committee (approval number: HR128/2012). Dissemination of the study results will occur

  15. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial

    PubMed Central

    Ly, Kien Hoa; Topooco, Naira; Cederlund, Hanna; Wallin, Anna; Bergström, Jan; Molander, Olof; Carlbring, Per; Andersson, Gerhard

    2015-01-01

    Background There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment - including four face-to-face sessions and a smartphone application - was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression. Methods This was a randomised controlled non-inferiority trial (NCT01819025) comparing a blended treatment (n=46) against a full ten-session treatment (n=47) for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment. Results Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen’s d=1.35; CI [−0.82, 3.52] to d=1.47; CI [−0.41, 3.35]; between group d=−0.13 CI [−2.37, 2.09] and d=−0.10 CI [−2.53, 2.33]). At the same time, the blended treatment reduced the therapist time with an average of 47%. Conclusions We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone applica¬tion as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression. Trial Registration Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025 PMID:26010890

  16. Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial

    PubMed Central

    2010-01-01

    using the Short Questionnaire to Assess Health-Enhancing Physical Activity and will be monitored with an exercise log and a pedometer. Discussion This study investigates the (cost)-effectiveness of exercise during adjuvant treatment of patients with breast or colon cancer. If early physical exercise proves to be (cost) effective, establishing standardised physical exercise programmes during cancer treatment will be planned. Trial registration Current Controlled trials ISRCTN43801571, Dutch Trial Register NTR2138 PMID:20534147

  17. 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

  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, 2014 CFR

    2014-07-01

    ... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of...)(7)—Products that contain a new active ingredient. An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for...

  19. 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.

  20. 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

  1. 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.

  2. Randomized controlled trial of the efficacy of aerobic exercise in reducing metabolic risk in healthy older people: The Hertfordshire Physical Activity Trial

    PubMed Central

    Finucane, Francis M; Horton, Jessica; Purslow, Lisa R; Savage, David B; Brage, Soren; Besson, Hervé; Horton, Kenneth; Rolfe, Ema De Lucia; Sleigh, Alison; Sharp, Stephen J; Martin, Helen J; Sayer, Avan Aihie; Cooper, Cyrus; Ekelund, Ulf; Griffin, Simon J; Wareham, Nicholas J

    2009-01-01

    Background While there are compelling observational data confirming that individuals who exercise are healthier, the efficacy of aerobic exercise interventions to reduce metabolic risk and improve insulin sensitivity in older people has not been fully elucidated. Furthermore, while low birth weight has been shown to predict adverse health outcomes later in life, its influence on the response to aerobic exercise is unknown. Our primary objective is to assess the efficacy of a fully supervised twelve week aerobic exercise intervention in reducing clustered metabolic risk in healthy older adults. A secondary objective is to determine the influence of low birth weight on the response to exercise in this group. Methods/Design We aim to recruit 100 participants born between 1931–1939, from the Hertfordshire Cohort Study and randomly assign them to no intervention or to 36 fully supervised one hour sessions on a cycle ergometer, over twelve weeks. Each participant will undergo detailed anthropometric and metabolic assessment pre- and post-intervention, including muscle biopsy, magnetic resonance imaging and spectroscopy, objective measurement of physical activity and sub-maximal fitness testing. Discussion Given the extensive phenotypic characterization, this study will provide valuable insights into the mechanisms underlying the beneficial effects of aerobic exercise as well as the efficacy, feasibility and safety of such interventions in this age group. Trial Registration Current Controlled Trials: ISRCTN60986572 PMID:19545359

  3. 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

  4. Intervention Effects on Adolescent Physical Activity in the Multicomponent SPACE Study: A Cluster Randomized Controlled Trial

    PubMed Central

    Toftager, Mette; Christiansen, Lars B.; Ersbøll, Annette K.; Kristensen, Peter L.; Due, Pernille; Troelsen, Jens

    2014-01-01

    Background Multicomponent school-based interventions have the potential to reduce the age-related decline in adolescents' physical activity (PA), yet there is not consistent evidence to guide non-curricular and school environment interventions. The aim of this study was to assess the effectiveness of a multicomponent environmental school-based intervention, designed to reduce the age-related decline in PA among adolescents. Methods A cluster randomized controlled trial was conducted with 7 intervention and 7 control schools. Baseline measurements were carried out in spring 2010 with 2 years of follow-up. A total of 1,348 students (11–13 years, in grade 5 and 6) enrolled in the study at baseline. The 14 schools included in the study were located in the Region of Southern Denmark. The intervention consisted of organizational and physical changes in the school environment with a total of 11 intervention components. The primary outcome measure was overall PA (cpm, counts per minute) and was supported by analyses of time spent in MVPA, and time spent sedentary. Furthermore, a secondary outcome measure was PA in school time and during recess. PA was measured using accelerometer (Actigraph GT3X). Results A total of 797 students completed the trial and had valid accelerometer data. No significant difference was found for overall PA with an adjusted difference of −19.1 cpm (95% CI: −93, 53) or for school time activity with an adjusted difference of 6 cpm (95% CI: −73, 85). A sensitivity analysis revealed a positive significant intervention effect of PA in recess with an adjusted difference of 95 cpm. Conclusions No evidence was found of the overall effect of a non-curricular multicomponent school-based intervention on PA among Danish adolescents. The intervention was positively associated with PA during school time and recess, however, with small estimates. Lack of effect on overall PA could be due to both program theory and different degrees of implementation

  5. 21 CFR 1301.13 - Application for registration; time for application; expiration date; registration for independent...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...; expiration date; registration for independent activities; application forms, fees, contents and signature... § 1301.13 Application for registration; time for application; expiration date; registration for... days before the expiration date of his/her registration, except that a bulk manufacturer of Schedule...

  6. Maintained physical activity and physiotherapy in the management of distal upper limb pain – a protocol for a randomised controlled trial (the arm pain trial)

    PubMed Central

    2014-01-01

    the evidence base underpinning the clinical management of patients with distal upper limb pain, and in particular, will provide guidance on whether they should be advised to rest the arm or remain active within the limits imposed by their symptoms. Trial registration Registered on http://www.controlled-trials.com (reference number: ISRCTN79085082). PMID:24612447

  7. 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

  8. Gamified physical activation of young men – a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study)

    PubMed Central

    2013-01-01

    can provide a translational model for community use. It can also be utilized as such or tailored to other selected populations or age groups. Trial registration ClinicalTrials.gov Identifier: NCT01376986 PMID:23311678

  9. 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

  10. CATCH: physical activity process evaluation in a multicenter trial.

    PubMed

    McKenzie, T L; Strikmiller, P K; Stone, E J; Woods, S E; Ehlinger, S S; Romero, K A; Budman, S T

    1994-01-01

    This paper presents the process evaluation model for the physical activity intervention component of the Child and Adolescent Trial for Cardiovascular Health (CATCH) and describes the major procedures used to monitor CATCH PE, the physical education intervention. The paper focuses on CATCH PE teacher training and in-service support as well as on the curriculum implementation. Monitoring training and support included assessing the in-service training workshops and the follow-up on-site assistance provided by staff. Monitoring the implementation included assessing the quantity and quality of CATCH PE instruction in terms of student physical activity engagement and lesson context, the fidelity of the curricular implementation, and the opportunities for other physical activity by children throughout the school day.

  11. 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

  12. Phosphorylation of mitogen-activated protein kinase by one-trial and multi-trial classical conditioning.

    PubMed

    Crow, T; Xue-Bian, J J; Siddiqi, V; Kang, Y; Neary, J T

    1998-05-01

    The pathway supporting the conditioned stimulus (CS) is one site of plasticity that has been studied extensively in conditioned Hermissenda. Several signal transduction pathways have been implicated in classical conditioning of this preparation, although the major emphasis has been on protein kinase C. Here we provide evidence for the activation and phosphorylation of a mitogen-activated protein kinase (MAPK) pathway by one-trial and multi-trial conditioning. A one-trial in vitro conditioning procedure consisting of light (CS) paired with the application of 5-HT results in the increased incorporation of 32PO4 into proteins detected with two-dimensional gel electrophoresis. Two of the phosphoproteins have molecular weights of 44 and 42 kDa, consistent with extracellular signal-regulated protein kinases (ERK1 and ERK2). Phosphorylation of the 44 and 42 kDa proteins by one-trial conditioning was inhibited by pretreatment with PD098059, A MEK1 (ERK-Activating kinase) inhibitor. Assays of ERK activity with brain myelin basic protein as a substrate revealed greater ERK activity for the group that received one-trial conditioning compared with an unpaired control group. Western blot analysis of phosphorylated ERK using antibodies recognizing the dually phosphorylated forms of ERK1 and ERK2 showed an increase in phosphorylation after one-trial conditioning compared with unpaired controls. The increased phosphorylation of ERK after one-trial conditioning was blocked by pretreatment with PD098059. Hermissenda that received 10 or 15 conditioning trials showed significant behavioral suppression compared with pseudo-random controls. After conditioning and behavioral testing, the conditioned animals showed significantly greater phosphorylation of ERK compared with the pseudo-random controls. These results show that the ERK-MAPK signaling pathway is activated in Pavlovian conditioning of Hermissenda.

  13. Effects of Long-Term Acupuncture Treatment on Resting-State Brain Activity in Migraine Patients: A Randomized Controlled Trial on Active Acupoints and Inactive Acupoints

    PubMed Central

    Zhao, Ling; Liu, Jixin; Zhang, Fuwen; Dong, Xilin; Peng, Yulin; Qin, Wei; Wu, Fumei; Li, Ying; Yuan, Kai; von Deneen, Karen M.; Gong, Qiyong; Tang, Zili; Liang, Fanrong

    2014-01-01

    Background Acupuncture has been commonly used for preventing migraine attacks and relieving pain during a migraine, although there is limited knowledge on the physiological mechanism behind this method. The objectives of this study were to compare the differences in brain activities evoked by active acupoints and inactive acupoints and to investigate the possible correlation between clinical variables and brain responses. Methods and Results A randomized controlled trial and resting-state functional magnetic resonance imaging (fMRI) were conducted. A total of eighty migraineurs without aura were enrolled to receive either active acupoint acupuncture or inactive acupoint acupuncture treatment for 8 weeks, and twenty patients in each group were randomly selected for the fMRI scan at the end of baseline and at the end of treatment. The neuroimaging data indicated that long-term active acupoint therapy elicited a more extensive and remarkable cerebral response compared with acupuncture at inactive acupoints. Most of the regions were involved in the pain matrix, lateral pain system, medial pain system, default mode network, and cognitive components of pain processing. Correlation analysis showed that the decrease in the visual analogue scale (VAS) was significantly related to the increased average Regional homogeneity (ReHo) values in the anterior cingulate cortex in the two groups. Moreover, the decrease in the VAS was associated with increased average ReHo values in the insula which could be detected in the active acupoint group. Conclusions Long-term active acupoint therapy and inactive acupoint therapy have different brain activities. We postulate that acupuncture at the active acupoint might have the potential effect of regulating some disease-affected key regions and the pain circuitry for migraine, and promote establishing psychophysical pain homeostasis. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-13003635 PMID:24915066

  14. Lifestyle intervention in general practice for physical activity, smoking, alcohol consumption and diet in elderly: a randomized controlled trial.

    PubMed

    Vrdoljak, Davorka; Marković, Biserka Bergman; Puljak, Livia; Lalić, Dragica Ivezić; Kranjčević, Ksenija; Vučak, Jasna

    2014-01-01

    The purpose of the study was to compare the effectiveness of programmed and intensified intervention on lifestyle changes, including physical activity, cigarette smoking, alcohol consumption and diet, in patients aged ≥ 65 with the usual care of general practitioners (GP). In this multicenter randomized controlled trial, 738 patients aged ≥ 65 were randomly assigned to receive intensified intervention (N = 371) or usual care (N = 367) of a GP for lifestyle changes, with 18-month follow-up. The main outcome measures were physical activity, smoking, alcohol consumption and diet. The study was conducted in 59 general practices in Croatia between May 2008 and May 2010. The patients' mean age was 72.3 ± 5.2 years. Significant diet correction was achieved after 18-month follow-up in the intervention group, comparing to controls. More patients followed strictly Mediterranean diet and consumed healthy foods more frequently. There was no significant difference between the groups in physical activity, tobacco smoking and alcohol consumption or diet after the intervention. In conclusion, an 18-month intensified GP's intervention had limited effect on lifestyle habits. GP intervention managed to change dietary habits in elderly population, which is encouraging since elderly population is very resistant regarding lifestyle habit changes. Clinical trial registration number. ISRCTN31857696.

  15. 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

  16. Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial

    PubMed Central

    Poirier, Josée; Bennett, Wendy L; Jerome, Gerald J; Shah, Nina G; Lazo, Mariana; Yeh, Hsin-Chieh; Clark, Jeanne M

    2016-01-01

    Background The benefits of physical activity are well documented, but scalable programs to promote activity are needed. Interventions that assign tailored and dynamically adjusting goals could effect significant increases in physical activity but have not yet been implemented at scale. Objective Our aim was to examine the effectiveness of an open access, Internet-based walking program that assigns daily step goals tailored to each participant. Methods A two-arm, pragmatic randomized controlled trial compared the intervention to no treatment. Participants were recruited from a workplace setting and randomized to a no-treatment control (n=133) or to treatment (n=132). Treatment participants received a free wireless activity tracker and enrolled in the walking program, Walkadoo. Assessments were fully automated: activity tracker recorded primary outcomes (steps) without intervention by the participant or investigators. The two arms were compared on change in steps per day from baseline to follow-up (after 6 weeks of treatment) using a two-tailed independent samples t test. Results Participants (N=265) were 66.0% (175/265) female with an average age of 39.9 years. Over half of the participants (142/265, 53.6%) were sedentary (<5000 steps/day) and 44.9% (119/265) were low to somewhat active (5000-9999 steps/day). The intervention group significantly increased their steps by 970 steps/day over control (P<.001), with treatment effects observed in sedentary (P=.04) and low-to-somewhat active (P=.004) participants alike. Conclusions The program is effective in increasing daily steps. Participants benefited from the program regardless of their initial activity level. A tailored, adaptive approach using wireless activity trackers is realistically implementable and scalable. Trial Registration Clinicaltrials.gov NCT02229409, https://clinicaltrials.gov/ct2/show/NCT02229409 (Archived by WebCite at http://www.webcitation.org/6eiWCvBYe) PMID:26860434

  17. 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....

  18. 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

  19. Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial

    PubMed Central

    2013-01-01

    Background Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity. Methods We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2). Diet was assessed by repeated triple pass 24-hour dietary recall and physical activity by accelerometry and questionnaire, at 16+0 to 18+6 and at 27+0 to 28+6 weeks’ gestation in women in control and intervention arms. Attitudes to behaviour change and quality of life were assessed and a process evaluation undertaken. The full RCT protocol was undertaken to assess feasibility. Results Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI −47 to −20), (p < 0.001) and saturated fat intake (−1.6% energy, 95% CI −2.8 to −0. 3) at 28 weeks’ gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks’ gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery. Conclusions This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a

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

    PubMed

    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

    2016-06-01

    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

  1. 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

  2. The effect of active warming in prehospital trauma care during road and air ambulance transportation - a clinical randomized trial

    PubMed Central

    2011-01-01

    Background Prevention and treatment of hypothermia by active warming in prehospital trauma care is recommended but scientifical evidence of its effectiveness in a clinical setting is scarce. The objective of this study was to evaluate the effect of additional active warming during road or air ambulance transportation of trauma patients. Methods Patients were assigned to either passive warming with blankets or passive warming with blankets with the addition of an active warming intervention using a large chemical heat pad applied to the upper torso. Ear canal temperature, subjective sensation of cold discomfort and vital signs were monitored. Results Mean core temperatures increased from 35.1°C (95% CI; 34.7-35.5°C) to 36.0°C (95% CI; 35.7-36.3°C) (p < 0.05) in patients assigned to passive warming only (n = 22) and from 35.6°C (95% CI; 35.2-36.0°C) to 36.4°C (95% CI; 36.1-36.7°C) (p < 0.05) in patients assigned to additional active warming (n = 26) with no significant differences between the groups. Cold discomfort decreased in 2/3 of patients assigned to passive warming only and in all patients assigned to additional active warming, the difference in cold discomfort change being statistically significant (p < 0.05). Patients assigned to additional active warming also presented a statistically significant decrease in heart rate and respiratory frequency (p < 0.05). Conclusions In mildly hypothermic trauma patients, with preserved shivering capacity, adequate passive warming is an effective treatment to establish a slow rewarming rate and to reduce cold discomfort during prehospital transportation. However, the addition of active warming using a chemical heat pad applied to the torso will significantly improve thermal comfort even further and might also reduce the cold induced stress response. Trial Registration ClinicalTrials.gov: NCT01400152 PMID:22017799

  3. APCAP - activated protein C in acute pancreatitis: a double-blind randomized human pilot trial

    PubMed Central

    2010-01-01

    .3, 95% CI -0.7 to +5.3). Treatment with APC was associated with an increase in serum levels of both total and conjugated bilirubin. No differences in ventilator-free days, in renal replacement therapy-free days, in vasopressor-free days, or in days alive outside the hospital were detected. Conclusions No serious bleeding or differences in the evolution of MOD were detected between APC and the placebo. Instead we found an increase in serum bilirubin in the APC group compared to the placebo group in patients with SAP. Trial registration ClinicalTrials.gov NCT01017107. PMID:20663207

  4. Action 3:30: protocol for a randomized feasibility trial of a teaching assistant led extracurricular physical activity intervention

    PubMed Central

    2013-01-01

    Background Many children do not meet physical activity (PA) guidelines. Extracurricular programmes could provide a mechanism to increase the PA levels of primary-school-aged children. Teaching assistants (TAs) are a valuable resource in all UK primary schools and could be trained to delivery after-school PA programmes. The aim of this feasibility study is to examine whether the Action 3:30 PA intervention, which is delivered by TAs, could be effective in increasing the PA of Year 5 and 6 children. Methods/Design A feasibility trial will be conducted in 20 primary schools. Schools will be randomly assigned to intervention or control arms. Intervention schools will receive a 25-hour TA training programme for two TAs, a first-aid certificate course for two TAs; ongoing TA support; 40 one-hour session plans that can be delivered by TAs; Action 3:30 clubs that run twice a week for 20 weeks; and ten sets of parent information sheets that are distributed biweekly. All measures will be assessed at baseline (Time 0), at the end of the intervention period (Time 1) and four months after the intervention has ended (Time 2). As this is a feasibility study, our primary interest is in estimating the recruitment of schools and children, adherence to the intervention, and completeness of data collection for outcomes and costs. As the most likely primary outcome measure in a future definitive trial will be accelerometer-determined minutes of moderate-to-vigorous PA (MVPA) per day, participants will wear accelerometers for five days (including two weekend days). Several psychosocial variables that could act as mediators in a future trial will be assessed via a questionnaire. Process evaluations of the session attendance, perceived enjoyment and perceived exertion will be assessed during the intervention. At the end of the intervention period, qualitative assessments will be conducted to identify how the programme could be improved before proceeding to a larger trial. Discussion The

  5. Promotion of physical activity and fitness in sedentary patients with Parkinson’s disease: randomised controlled trial

    PubMed Central

    van Nimwegen, Marlies; Speelman, Arlène D; Overeem, Sebastiaan; van de Warrenburg, Bart P; Smulders, Katrijn; Dontje, Manon L; Borm, George F; Backx, Frank J G; Munneke, Marten

    2013-01-01

    activity, as measured with the LAPAQ. The analysis of the secondary endpoints justifies further work into the possible merits of behavioural change programmes to increase physical activities in daily life in Parkinson’s disease. Trial registration Clinical trials NCT00748488. PMID:23457213

  6. 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:...

  7. 77 FR 26281 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed... Product Establishments and Listing of Ingredients in Tobacco Products AGENCY: Food and Drug Administration, HHS. ] ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an...

  8. Changes in CVD risk factors in the activity counseling trial

    PubMed Central

    Baruth, Meghan; Wilcox, Sara; Sallis, James F; King, Abby C; Marcus, Bess H; Blair, Steven N

    2011-01-01

    Primary care facilities may be a natural setting for delivering interventions that focus on behaviors that improve cardiovascular disease (CVD) risk factors. The purpose of this study was to examine the 24-month effects of the Activity Counseling Trial (ACT) on CVD risk factors, to examine whether changes in CVD risk factors differed according to baseline risk factor status, and to examine whether changes in fitness were associated with changes in CVD risk factors. ACT was a 24-month multicenter randomized controlled trial to increase physical activity. Participants were 874 inactive men and women aged 35–74 years. Participants were randomly assigned to one of three arms that varied by level of counseling, intensity, and resource requirements. Because there were no significant differences in change over time between arms on any of the CVD risk factors examined, all arms were combined, and the effects of time, independent of arm, were examined separately for men and women. Time × Baseline risk factor status interactions examined whether changes in CVD risk factors differed according to baseline risk factor status. Significant improvements in total cholesterol, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol, the ratio of total cholesterol to HDL-C, and triglycerides were seen in both men and women who had high (or low for HDL-C) baseline levels of risk factors, whereas significant improvements in diastolic blood pressure were seen only in those men with high baseline levels. There were no improvements in any risk factors among participants with normal baseline levels. Changes in fitness were associated with changes in a number of CVD risk factors. However, most relationships disappeared after controlling for changes in body weight. Improvements in lipids from the ACT interventions could reduce the risk of coronary heart disease in people with already high levels of lipids by 16%–26% in men and 11%–16% in women

  9. Patient Activation through Counseling and Exercise – Acute Leukemia (PACE-AL) – a randomized controlled trial

    PubMed Central

    2013-01-01

    exercise and health promotion counseling on functional and physical capacity, the symptom burden and quality of life in patients with acute leukemia during out patient management. The results will inform clinical practice exercise guidelines and rehabilitation programs for patients undergoing treatment for acute leukemia. Optimizing the treatment and care pathway may ease the transition for patients from illness to the resumption of everyday activities. Trial registration ClinicalTrials.gov Identifier: NCT01404520. PMID:24083543

  10. 76 FR 65730 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... information collection in current part 207. In the Federal Register of August 29, 2006 (71 FR 51276), FDA... 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...

  11. 78 FR 14586 - Agency Information Collection Activities: Application for Civil Surgeon Designation Registration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-06

    ... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Application.... Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment... Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security....

  12. 77 FR 48519 - Registration Applications for Pesticide Products Containing New Active Ingredients

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    .... israelensis, Strain SUM-6218 at 100.0%. Product Type: microbial insecticide. Proposed Use: Manufacturing use..., Kalamazoo, MI 49008. Active Ingredient: GS-U-ACTX-Hv1a-SEQ2 at 30.00%. Product Type: Insecticide. Proposed...%. Product Type: Insecticide. Proposed Uses: For use on ornamental plants, turf, vegetables, fruits,...

  13. 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

  14. 28 CFR 10.2 - Language of registration statement.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 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 be... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Language of registration statement....

  15. 28 CFR 10.2 - Language of registration statement.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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 be... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Language of registration statement....

  16. 28 CFR 10.2 - Language of registration statement.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 1 2011-07-01 2011-07-01 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...

  17. 28 CFR 10.2 - Language of registration statement.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 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...

  18. 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

  19. 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

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

    PubMed

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

    2016-07-01

    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

  1. Information system for the registration of pollution sources associated with construction activities.

    PubMed

    Demel, J; Hora, V; Sura, M

    1995-01-01

    A prospective builder in Czech Republic has to apply for approval by local (regional, state) authorities and is liable, in the Environmental Impact Assessment (EIA) process to make an accurate statement of stress factor values produced during the life cycle of the construction work.These data should be kept in the information system, as only a substantial amount of relevant high quality data can be used in the decision-making process.Identifying and quantifying stress factors produced by a given construction activity can present a problem due to inadequate knowledge and opinion in this field. For large construction works, a knowledge-based system proposed in the second part of this paper may be useful; small structures can be covered by the information given as to local factors, which form part of the information system proposed by Vlcek and Moos (1991). PMID:24202046

  2. Caffeine Intake, Short Bouts of Physical Activity, and Energy Expenditure: A Double-Blind Randomized Crossover Trial

    PubMed Central

    Júdice, Pedro B.; Matias, Catarina N.; Santos, Diana A.; Magalhães, João P.; Hamilton, Marc T.; Sardinha, Luís B.; Silva, Analiza M.

    2013-01-01

    PA energy expenditure (PAEE) is the most variable component of Total Energy Expenditure (TEE) and largely due to the balance of sedentary time (SedT) and low intensity physical activity (LIPA). There has been an emergence for seeking an understanding of factors which determine variations in SedT, LIPA, and PAEE. Sedentary behavior and physical activity are relatively resistant to change by experimental dietary treatments and significant body weight changes. Although caffeine (Caf) is by far the most heavily used nutritional agent ingested to promote a sense of vigor/alertness, it is still unknown if Caf is effective in increasing PAEE and physical activity. The aim of the study was to test the hypothesis that 2 daily doses of Caf (as a capsule to blind the treatment and divided equally during breakfast and lunch) increase PAEE and TEE, and it would do so through increasing the frequent and brief bouts of physical activity (~1-5 min long) through the day as measured by accelerometry. In 21 low Caf users (<100 mg day-1), we used a double-blind crossover trial (ClinicalTrials.govID;NCT01477294) with two conditions (4-day each with a 3-day washout period) randomly ordered as 5 mg kg-1 day-1 of Caf and maltodextrin as placebo (Plc). Resting energy expenditure (REE) by indirect calorimetry, total energy expenditure (TEE) from doubly labeled water, PAEE calculated as TEE-(REE+0.1TEE), and accelerometry measurements of both LIPA and MVPA were not different between conditions. However, regardless of caffeine or placebo, there were several significant relationships between brief bouts of LIPA and MVPA with PAEE. In conclusion, this double-blind study found that low and moderate-vigorous activity as well as the total volume of PAEE in free-living conditions is resistant to dietary caffeine intake that was equivalent to 5 cups of espresso or 7 cups of tea. Trial Registration ClinicalTrials.gov NCT01477294 PMID:23869233

  3. No Sustained Attention Differences in a Longitudinal Randomized Trial Comparing Mindfulness Based Stress Reduction versus Active Control

    PubMed Central

    MacCoon, Donal G.; MacLean, Katherine A.; Davidson, Richard J.; Saron, Clifford D.; Lutz, Antoine

    2014-01-01

    Background Mindfulness Based Stress Reduction (MBSR) is a secular form of meditation training. The vast majority of the extant literature investigating the health effects of mindfulness interventions relies on wait-list control comparisons. Previous studies have found that meditation training over several months is associated with improvements in cognitive control and attention. Methodology/Principal Findings We used a visual continuous performance task (CPT) to test the effects of eight weeks of mindfulness training on sustained attention by comparing MBSR to the Health Enhancement Program (HEP), a structurally equivalent, active control condition in a randomized, longitudinal design (ClinicalTrials.gov, NCT01301105) focusing on a non-clinical population typical of MBSR participants. Researchers were blind to group assignment. 63 community participants were randomized to either MBSR (n = 31) or HEP (n = 32). CPT analyses were conducted on 29 MBSR participants and 25 HEP participants. We predicted that MBSR would improve visual discrimination ability and sustained attention over time on the CPT compared to HEP, with more home practice associated with greater improvements. Our hypotheses were not confirmed but we did find some evidence for improved visual discrimination similar to effects in partial replication of other research. Our study had sufficient power to demonstrate that intervention groups do not differ in their improvement over time in sustained attention performance. One of our primary predictions concerning the effects of intervention on attentional fatigue was significant but not interpretable. Conclusions Attentional sensitivity is not affected by mindfulness practice as taught in MBSR, but it is unclear whether mindfulness might positively affect another aspect of attention, vigilance. These results also highlight the relevant procedural modifications required by future research to correctly investigate the role of sustained attention in

  4. The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components. Methods/Design This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period. Discussion The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed. Trial registration ClinicalTrials.gov: NCT01619930 PMID:23374879

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. Ongoing activity in the optic tectum is correlated on a trial-by-trial basis with the pupil dilation response.

    PubMed

    Netser, Shai; Dutta, Arkadeb; Gutfreund, Yoram

    2014-03-01

    The selection of the appropriate stimulus to induce an orienting response is a basic task thought to be partly achieved by tectal circuitry. Here we addressed the relationship between neural activity in the optic tectum (OT) and orienting behavioral responses. We recorded multiunit activity in the intermediate/deep layers of the OT of the barn owl simultaneously with pupil dilation responses (PDR, a well-known orienting response common to birds and mammals). A trial-by-trial analysis of the responses revealed that the PDR generally did not correlate with the evoked neural responses but significantly correlated with the rate of ongoing neural activity measured shortly before the stimulus. Following this finding, we characterized ongoing activity in the OT and showed that in the intermediate/deep layers it tended to fluctuate spontaneously. It is characterized by short periods of high ongoing activity during which the probability of a PDR to an auditory stimulus inside the receptive field is increased. These high-ongoing activity periods were correlated with increase in the power of gamma band local field potential oscillations. Through dual recordings, we showed that the correlation coefficients of ongoing activity decreased as a function of distance between recording sites in the tectal map. Significant correlations were also found between recording sites in the OT and the forebrain entopallium. Our results suggest that an increase of ongoing activity in the OT reflects an internal state during which coupling between sensory stimulation and behavioral responses increases.

  12. Ongoing activity in the optic tectum is correlated on a trial-by-trial basis with the pupil dilation response.

    PubMed

    Netser, Shai; Dutta, Arkadeb; Gutfreund, Yoram

    2014-03-01

    The selection of the appropriate stimulus to induce an orienting response is a basic task thought to be partly achieved by tectal circuitry. Here we addressed the relationship between neural activity in the optic tectum (OT) and orienting behavioral responses. We recorded multiunit activity in the intermediate/deep layers of the OT of the barn owl simultaneously with pupil dilation responses (PDR, a well-known orienting response common to birds and mammals). A trial-by-trial analysis of the responses revealed that the PDR generally did not correlate with the evoked neural responses but significantly correlated with the rate of ongoing neural activity measured shortly before the stimulus. Following this finding, we characterized ongoing activity in the OT and showed that in the intermediate/deep layers it tended to fluctuate spontaneously. It is characterized by short periods of high ongoing activity during which the probability of a PDR to an auditory stimulus inside the receptive field is increased. These high-ongoing activity periods were correlated with increase in the power of gamma band local field potential oscillations. Through dual recordings, we showed that the correlation coefficients of ongoing activity decreased as a function of distance between recording sites in the tectal map. Significant correlations were also found between recording sites in the OT and the forebrain entopallium. Our results suggest that an increase of ongoing activity in the OT reflects an internal state during which coupling between sensory stimulation and behavioral responses increases. PMID:24304859

  13. “Girls on the Move” intervention protocol for increasing physical activity among low-active underserved urban girls: a group randomized trial

    PubMed Central

    2013-01-01

    -to-foot bioelectric impedance scale. Linear mixed effects regression analyses will be performed to assess intervention effects. Discussion This multi-component approach is expected to improve girls’ moderate to vigorous physical activity and related physical outcomes. Trial Registration ClinicalTrials.gov Identifier NCT01503333 PMID:23672272

  14. 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

  15. Tobacco Assessment in Actively Accruing National Cancer Institute Cooperative Group Program Clinical Trials

    PubMed Central

    Peters, Erica N.; Torres, Essie; Toll, Benjamin A.; Cummings, K. Michael; Gritz, Ellen R.; Hyland, Andrew; Herbst, Roy S.; Marshall, James R.; Warren, Graham W.

    2012-01-01

    Purpose Substantial evidence suggests that tobacco use has adverse effects on cancer treatment outcomes; however, routine assessment of tobacco use has not been fully incorporated into standard clinical oncology practice. The purpose of this study was to evaluate tobacco use assessment in patients enrolled onto actively accruing cancer clinical trials. Methods Protocols and forms for 155 actively accruing trials in the National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program were evaluated for tobacco use assessment at enrollment and follow-up by using a structured coding instrument. Results Of the 155 clinical trials reviewed, 45 (29%) assessed any form of tobacco use at enrollment, but only 34 (21.9%) assessed current cigarette use. Only seven trials (4.5%) assessed any form of tobacco use during follow-up. Secondhand smoke exposure was captured in 2.6% of trials at enrollment and 0.6% during follow-up. None of the trials assessed nicotine dependence or interest in quitting at any point during enrollment or treatment. Tobacco status assessment was higher in lung/head and neck trials as well as phase III trials, but there was no difference according to year of starting accrual or cooperative group. Conclusion Most actively accruing cooperative group clinical trials do not assess tobacco use, and there is no observable trend in improvement over the past 8 years. Failure to incorporate standardized tobacco assessments into NCI-funded Cooperative Group Clinical Trials will limit the ability to provide evidence-based cessation support and will limit the ability to accurately understand the precise effect of tobacco use on cancer treatment outcomes. PMID:22689794

  16. Effect of a governmentally-led physical activity program on motor skills in young children attending child care centers: a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Objective To assess the effect of a governmentally-led center based child care physical activity program (Youp’là Bouge) on child motor skills. Patients and methods We conducted a single blinded cluster randomized controlled trial in 58 Swiss child care centers. Centers were randomly selected and 1:1 assigned to a control or intervention group. The intervention lasted from September 2009 to June 2010 and included training of the educators, adaptation of the child care built environment, parental involvement and daily physical activity. Motor skill was the primary outcome and body mass index (BMI), physical activity and quality of life secondary outcomes. The intervention implementation was also assessed. Results At baseline, 648 children present on the motor test day were included (age 3.3 ± 0.6, BMI 16.3 ± 1.3 kg/m2, 13.2% overweight, 49% girls) and 313 received the intervention. Relative to children in the control group (n = 201), children in the intervention group (n = 187) showed no significant increase in motor skills (delta of mean change (95% confidence interval: -0.2 (−0.8 to 0.3), p = 0.43) or in any of the secondary outcomes. Not all child care centers implemented all the intervention components. Within the intervention group, several predictors were positively associated with trial outcomes: 1) free-access to a movement space and parental information session for motor skills 2) highly motivated and trained educators for BMI 3) free-access to a movement space and purchase of mobile equipment for physical activity (all p < 0.05). Conclusion This “real-life” physical activity program in child care centers confirms the complexity of implementing an intervention outside a study setting and identified potentially relevant predictors that could improve future programs. Trial registration Clinical trials.gov NCT00967460 PMID:23835207

  17. 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

  18. 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

  19. A hybrid framework of multiple active appearance models and global registration for 3D prostate segmentation in MRI

    NASA Astrophysics Data System (ADS)

    Ghose, Soumya; Oliver, Arnau; Martí, Robert; Lladó, Xavier; Freixenet, Jordi; Mitra, Jhimli; Vilanova, Joan C.; Meriaudeau, Fabrice

    2012-02-01

    Real-time fusion of Magnetic Resonance (MR) and Trans Rectal Ultra Sound (TRUS) images aid in the localization of malignant tissues in TRUS guided prostate biopsy. Registration performed on segmented contours of the prostate reduces computational complexity and improves the multimodal registration accuracy. However, accurate and computationally efficient 3D segmentation of the prostate in MR images could be a challenging task due to inter-patient shape and intensity variability of the prostate gland. In this work, we propose to use multiple statistical shape and appearance models to segment the prostate in 2D and a global registration framework to impose shape restriction in 3D. Multiple mean parametric models of the shape and appearance corresponding to the apex, central and base regions of the prostate gland are derived from principal component analysis (PCA) of prior shape and intensity information of the prostate from the training data. The estimated parameters are then modified with the prior knowledge of the optimization space to achieve segmentation in 2D. The 2D segmented slices are then rigidly registered with the average 3D model produced by affine registration of the ground truth of the training datasets to minimize pose variations and impose 3D shape restriction. The proposed method achieves a mean Dice similarity coefficient (DSC) value of 0.88+/-0.11, and mean Hausdorff distance (HD) of 3.38+/-2.81 mm when validated with 15 prostate volumes of a public dataset in leave-one-out validation framework. The results achieved are better compared to some of the works in the literature.

  20. 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

  1. Study of Health and Activity in Preschool Environments (SHAPES): Study protocol for a randomized trial evaluating a multi-component physical activity intervention in preschool children

    PubMed Central

    2013-01-01

    battery was also used to monitor dose delivered by interventionists, completeness of intervention component delivery by teachers, and fidelity of teachers’ implementation. Discussion The study will address important gaps relative to increasing physical activity in preschool children. Few studies to date have incorporated a multi-component approach, rigorous measurement protocol, and thorough evaluation of intervention implementation. Trial registration NCT01885325 PMID:23919808

  2. 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

  3. Towards a physically more active lifestyle based on one’s own values: study design of a randomized controlled trial for physically inactive adults

    PubMed Central

    2013-01-01

    discuss challenges in motivating physically inactive adults towards physically more active lifestyles. Trial registration ClinicalTrials.gov, number NCT01796990. PMID:23866812

  4. Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers. Methods/Design COBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life. Discussion The clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline

  5. Improving diet, physical activity and other lifestyle behaviours using computer-tailored advice in general practice: a randomised controlled trial

    PubMed Central

    2012-01-01

    Background The adoption and maintenance of healthy behaviours is essential in the primary prevention of chronic non-communicable diseases. This study evaluated the effectiveness of a minimal intervention on multiple lifestyle factors such as diet, physical activity, smoking and alcohol, delivered through general practice, using computer-tailored feedback. Methods Adult patients visiting 21 general practitioners in Brisbane, Australia, were surveyed about ten health behaviours that are risk factors for chronic, non-communicable diseases. Those who completed the self-administered baseline questionnaire entered a randomised controlled trial, with the intervention group receiving computer-tailored printed advice, targeting those health behaviours for which respondents were not meeting current recommendations. The primary outcome was change in summary lifestyle score (Prudence Score) and individual health behaviours at three months. A repeated measures analysis compared change in these outcomes in intervention and control groups after adjusting for age and education. Results 2306 patients were randomised into the trial. 1711 (76%) returned the follow-up questionnaire at 3 months. The Prudence Score (10 items) in the intervention group at baseline was 5.88, improving to 6.25 at 3 months (improvement = 0.37), compared with 5.84 to 5.96 (improvement = 0.12) in the control group (F = 13.3, p = 0.01). The intervention group showed improvement in meeting recommendations for all individual health behaviours compared with the control group. However, these differences were significant only for fish intake (OR 1.37, 95% CI 1.11-1.68), salt intake (OR 1.19, 95% CI 1.05-1.38), and type of spread used (OR 1.28, 95% CI 1.06-1.51). Conclusion A minimal intervention using computer-tailored feedback to address multiple lifestyle behaviours can facilitate change and improve unhealthy behaviours. Although individual behaviour changes were modest, when implemented on a

  6. 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

  7. A Randomized Trial to Assess Anti-HIV Activity in Female Genital Tract Secretions and Soluble Mucosal Immunity Following Application of 1% Tenofovir Gel

    PubMed Central

    Torres, N. Merna; Fazzari, Melissa J.; Cho, Sylvia; Kalyoussef, Sabah; Shust, Gail; Mesquita, Pedro M. M.; Louissaint, Nicolette; Chen, Jianmeng; Cohen, Hillel W.; Diament, Erin C.; Lee, Anna C.; Soto-Torres, Lydia; Hendrix, Craig W.; Herold, Betsy C.

    2011-01-01

    Background Preclinical and early phase clinical microbicide studies have not consistently predicted the outcome of efficacy trials. To address this gap, candidate biomarkers of microbicide pharmacodynamics and safety were evaluated in a double-blind, placebo-controlled trial of tenofovir gel, the first microbicide to demonstrate significant protection against HIV acquisition. Methods 30 women were randomized to apply a single daily dose of tenofovir or placebo gel for 14 consecutive days. Anti-HIV activity was measured in cervicovaginal lavage (CVL) on Days 0, 3, 7, 14 and 21 by luciferase assay as a surrogate marker of pharmacodynamics. Endogenous activity against E. coli and HSV-2 and concentrations of immune mediators were quantified in CVL as candidate biomarkers of safety. Tenofovir levels were measured in CVL and blood. Results A significant increase in anti-HIV activity was detected in CVL from women who applied tenofovir gel compared to their endogenous anti-HIV activity in genital tract secretions on Day 0 and compared to activity in CVL from women in the placebo group. The activity correlated significantly with CVL concentration of tenofovir (r = 0.6, p<0.001) and fit a sigmoid Emax pharmacodynamic model. Anti-HIV activity in CVL from women who applied tenofovir persisted when virus was introduced in semen, whereas endogenous anti-HIV activity decreased. Tenofovir did not trigger an inflammatory response or induce sustained loss in endogenous antimicrobial activity or immune mediators. Conclusions Tenofovir gel had no deleterious impact on soluble mucosal immunity. The increased anti-HIV activity in CVL, which persisted in the presence of semen and correlated with tenofovir concentration, is consistent with the efficacy observed in a recent clinical trial. These results promote quantified CVL anti-HIV activity as a surrogate of tissue pharmacodynamics and as a potential biomarker of adherence to product. This simple, feasible and inexpensive bioassay

  8. 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

  9. Undergraduate Cross Registration.

    ERIC Educational Resources Information Center

    Grupe, Fritz H.

    This report discusses various aspects of undergraduate cross-registration procedures, including the dimensions, values, roles and functions, basic assumptions, and facilitating and encouragment of cross-registration. Dimensions of cross-registration encompass financial exchange, eligibility, program limitations, type of grade and credit; extent of…

  10. The cost-effectiveness of the MobileMums intervention to increase physical activity among mothers with young children: a Markov model informed by a randomised controlled trial

    PubMed Central

    Burn, Edward; Barnett, Adrian G; Fjeldsoe, Brianna S; Graves, Nicholas

    2015-01-01

    Objectives To determine the cost-effectiveness of the MobileMums intervention. MobileMums is a 12-week programme which assists mothers with young children to be more physically active, primarily through the use of personalised SMS text-messages. Design A cost-effectiveness analysis using a Markov model to estimate and compare the costs and consequences of MobileMums and usual care. Setting This study considers the cost-effectiveness of MobileMums in Queensland, Australia. Participants A hypothetical cohort of over 36 000 women with a child under 1 year old is considered. These women are expected to be eligible and willing to participate in the intervention in Queensland, Australia. Data sources The model was informed by the effectiveness results from a 9-month two-arm community-based randomised controlled trial undertaken in 2011 and registered retrospectively with the Australian Clinical Trials Registry (ACTRN12611000481976). Baseline characteristics for the model cohort, treatment effects and resource utilisation were all informed by this trial. Main outcome measures The incremental cost per quality-adjusted life year (QALY) of MobileMums compared with usual care. Results The intervention is estimated to lead to an increase of 131 QALYs for an additional cost to the health system of 1.1 million Australian dollars (AUD). The expected incremental cost-effectiveness ratio for MobileMums is 8608 AUD per QALY gained. MobileMums has a 98% probability of being cost-effective at a cost-effectiveness threshold of 64 000 AUD. Varying modelling assumptions has little effect on this result. Conclusions At a cost-effectiveness threshold of 64 000 AUD, MobileMums would likely be a cost-effective use of healthcare resources in Queensland, Australia. Trial registration number Australian Clinical Trials Registry; ACTRN12611000481976. PMID:25926145

  11. 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

  12. Feedback about more accurate versus less accurate trials: differential effects on self-confidence and activation.

    PubMed

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

    2012-06-01

    One purpose of the present study was to examine whether self-confidence or anxiety would be differentially affected byfeedback 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 two conditions: one group received feedback on the most accurate trials, whereas another group received feedback on the least accurate trials. On day 2, participants completed an anxiety questionnaire and performed a retention test. Shin conductance level, as a measure of arousal, was determined. The results indicated that feedback about more accurate trials resulted in more effective learning as well as increased self-confidence. Also, activation was a predictor of performance. PMID:22808705

  13. Examining Participant Engagement in an Information Technology-Based Physical Activity and Nutrition Intervention for Men: The Manup Randomized Controlled Trial

    PubMed Central

    Vandelanotte, Corneel; Dixon, Marcus W; Rosenkranz, Richard; Caperchione, Cristina; Hooker, Cindy; Karunanithi, Mohan; Kolt, Gregory S; Maeder, Anthony; Ding, Hang; Taylor, Pennie; Duncan, Mitch J

    2014-01-01

    Background Males experience a shorter life expectancy and higher rates of chronic diseases compared to their female counterparts. To improve health outcomes among males, interventions specifically developed for males that target their health behaviors are needed. Information technology (IT)-based interventions may be a promising intervention approach in this population group, however, little is known about how to maximize engagement and retention in Web-based programs. Objective The current study sought to explore attributes hypothesized to influence user engagement among a subsample of participants from the ManUp study, a randomized controlled trial testing the efficacy of an interactive Web-based intervention for promoting physical activity and nutrition among middle-aged males. Methods Semistructured interviews were conducted and audiotaped with 20 of the ManUp participants. Interview questions were based on a conceptual model of engagement and centered on why participants took part in the study, what they liked and did not like about the intervention they received, and how they think the intervention could be improved. Interview recordings were transcribed and coded into themes. Results There were five themes that were identified in the study. These themes were: (1) users’ motives, (2) users’ desired outcomes, (3) users’ positive experiences, (4) users’ negative emotions, and (5) attributes desired by user. Conclusions There is little research in the field that has explored user experiences in human-computer interactions and how such experiences may relate to engagement, especially among males. Although not conclusive, the current study provides some insight into what personal attributes of middle-aged males (such as their key motives and goals for participating) and attributes of the intervention materials (such as usability, control, and interactivity) may impact on user engagement in this group. These findings will be helpful for informing the design

  14. 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.

  15. 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

  16. 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.

  17. 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

  18. Discontinuation of Contact Precautions for Methicillin-Resistant Staphylococcus aureus: A Randomized Controlled Trial Comparing Passive and Active Screening With Culture and Polymerase Chain Reaction

    PubMed Central

    Shenoy, Erica S.; Kim, JiYeon; Rosenberg, Eric S.; Cotter, Jessica A.; Lee, Hang; Walensky, Rochelle P.; Hooper, David C.

    2013-01-01

    Background. There have been no randomized controlled trials comparing active and passive screening for documenting clearance of colonization with methicillin-resistant Staphylococcus aureus (MRSA). We compared the efficacy of active and passive screening using both culture and commercial polymerase chain reaction (PCR) for documentation of MRSA clearance and discontinuation of MRSA contact precautions (CPs). Methods. Inpatients with a history of MRSA infection or colonization enrolled between December 2010 and September 2011 were randomized to either passive (nonintervention arm; n = 202; observation with local standard of care) or active screening (intervention arm; n = 405; study staff screened using culture and commercial PCR). The primary outcome was discontinuation of CPs by trial arm based on 3 negative cultures. In the intervention arm, sensitivity, specificity, and positive and negative predictive values of the first PCR were compared to cultures. Results. CPs were discontinued significantly more often (rate ratio [RR], 4.1; 95% confidence interval [CI], 2.3%–7.1%) in the intervention arm, including in an intent-to-screen analysis (RR, 2.6; 95% CI, 1.5%–4.7%). The first PCR, compared to 3 cultures, detected MRSA with a sensitivity of 93.9% (95% CI, 85.4%–97.6%), a specificity of 92.0% (95% CI, 85.9%–95.6%), a positive predictive value of 86.1% (95% CI, 75.9%–93.1%), and a negative predictive value of 96.6% (95% CI, 91.6%–99.1%). Conclusions. Compared to passive screening using culture methods, active screening resulted in discontinuation of MRSA CPs at a significantly higher frequency. Active screening with a single PCR would significantly increase the completion of the screening process. Clinical Trials Registration. NCT01234831. PMID:23572482

  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. The BLISS cluster randomised controlled trial of the effect of 'active dissemination of information' on standards of care for premature babies in England (BEADI) study protocol [ISRCTN89683698

    PubMed Central

    Acolet, Dominique; Jelphs, Kim; Davidson, Deborah; Peck, Edward; Clemens, Felicity; Houston, Rosie; Weindling, Michael; Lavis, John; Elbourne, Diana

    2007-01-01

    Background Gaps between research knowledge and practice have been consistently reported. Traditional ways of communicating information have limited impact on practice changes. Strategies to disseminate information need to be more interactive and based on techniques reported in systematic reviews of implementation of changes. There is a need for clarification as to which dissemination strategies work best to translate evidence into practice in neonatal units across England. The objective of this trial is to assess whether an innovative active strategy for the dissemination of neonatal research findings, recommendations, and national neonatal guidelines is more likely to lead to changes in policy and practice than the traditional (more passive) forms of dissemination in England. Methods/design Cluster randomised controlled trial of all neonatal units in England (randomised by hospital, n = 182 and stratified by neonatal regional networks and neonatal units level of care) to assess the relative effectiveness of active dissemination strategies on changes in local policies and practices. Participants will be mainly consultant lead clinicians in each unit. The intervention will be multifaceted using: audit and feedback; educational meetings for local staff (evidence-based lectures on selected topics, interactive workshop to examine current practice and draw up plans for change); and quality improvement and organisational changes methods. Policies and practice outcomes for the babies involved will be collected before and after the intervention. Outcomes will assess all premature babies born in England during a three month period for timing of surfactant administration at birth, temperature control at birth, and resuscitation team (qualification and numbers) present at birth. Trial registration Current controlled trials ISRCTN89683698 PMID:17922901

  1. My Activity Coach – Using video-coaching to assist a web-based computer-tailored physical activity intervention: a randomised controlled trial protocol

    PubMed Central

    2014-01-01

    computer-tailored physical activity advice. This may increase intervention effectiveness at an acceptable cost and will inform the development of future web-based physical activity interventions. Trial registration ACTRN12614000339651Date: 31/03/2014. PMID:25047900

  2. Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial

    PubMed Central

    Ly, Kien Hoa; Trüschel, Anna; Jarl, Linnea; Magnusson, Susanna; Windahl, Tove; Johansson, Robert; Carlbring, Per; Andersson, Gerhard

    2014-01-01

    Objectives Evaluating and comparing the effectiveness of two smartphone-delivered treatments: one based on behavioural activation (BA) and other on mindfulness. Design Parallel randomised controlled, open, trial. Participants were allocated using an online randomisation tool, handled by an independent person who was separate from the staff conducting the study. Setting General community, with recruitment nationally through mass media and advertisements. Participants 40 participants diagnosed with major depressive disorder received a BA treatment, and 41 participants received a mindfulness treatment. 9 participants were lost at the post-treatment. Intervention BA: An 8-week long behaviour programme administered via a smartphone application. Mindfulness: An 8-week long mindfulness programme, administered via a smartphone application. Main outcome measures The Beck Depression Inventory-II (BDI-II) and the nine-item Patient Health Questionnaire Depression Scale (PHQ-9). Results 81 participants were randomised (mean age 36.0 years (SD=10.8)) and analysed. Results showed no significant interaction effects of group and time on any of the outcome measures either from pretreatment to post-treatment or from pretreatment to the 6-month follow-up. Subgroup analyses showed that the BA treatment was more effective than the mindfulness treatment among participants with higher initial severity of depression from pretreatment to the 6-month follow-up (PHQ-9: F (1, 362.1)=5.2, p<0.05). In contrast, the mindfulness treatment worked better than the BA treatment among participants with lower initial severity from pretreatment to the 6-month follow-up (PHQ-9: F (1, 69.3)=7.7, p<0.01); BDI-II: (F(1, 53.60)=6.25, p<0.05). Conclusions The two interventions did not differ significantly from one another. For participants with higher severity of depression, the treatment based on BA was superior to the treatment based on mindfulness. For participants with lower initial severity, the

  3. 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

  4. Weekend Schoolyard Accessibility, Physical Activity, and Obesity: The Trial of Activity in Adolescent Girls (TAAG) Study

    PubMed Central

    Scott, Molly M; Cohen, Deborah A; Evenson, Kelly R; Elder, John; Catellier, Diane; Ashwood, J. Scott; Overton, Adrian

    2007-01-01

    Objectives To assess the accessibility and suitability of schools as recreational sites and to determine whether they are associated with young adolescent girls’ weekend metabolic equivalent-weighted moderate-to-vigorous (MW-MVPA) physical activity and body mass index (BMI). Methods We drew a half-mile (0.805 km) radius around the residences of participants in Trial of Activity for Adolescent Girls (n=1556) in Maryland, South Carolina, Minnesota, Louisiana, California, and Arizona. We visited all schools and parks within the defined distance and documented their amenities and accessibility on Saturdays in Spring 2003. Staff gathered data on each girls’ height and weight and used accelerometers to record weekend MW-MVPA. Results Schools represented 44% of potential neighborhood sites for physical activity. However, a third of schools were inaccessible on the Saturday we visited. Neighborhoods with locked schools were primarily non-white, older, more densely populated, and of lower socioeconomic status. Though there was no relationship between school accessibility on Saturdays and weekend MW-MVPA, the number of locked schools was associated with significantly higher BMI. Conclusions The lack of relationship between MW-MVPA and school accessibility may imply that young adolescent girls do not identify schools as recreational resources. However, due to the association between BMI and locked schools, efforts to stem the obesity epidemic should include making schools more accessible. PMID:17292958

  5. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  6. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  7. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  8. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  9. Recruiting a Diverse Group of Middle School Girls into the Trial of Activity for Adolescent Girls

    ERIC Educational Resources Information Center

    Elder, John P.; Shuler, LaVerne; Moe, Stacey G.; Grieser, Mira; Pratt, Charlotte; Cameron, Sandra; Hingle, Melanie; Pickrel, Julie L.; Saksvig, Brit I.; Schachter, Kenneth; Greer, Susan; Bothwell, Elizabeth K. Guth

    2008-01-01

    Background: School-based study recruitment efforts are both time consuming and challenging. This paper highlights the recruitment strategies employed by the national, multisite Trial of Activity for Adolescent Girls (TAAG), a study designed to measure the effectiveness of an intervention to reduce the decline of physical activity levels among…

  10. 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

  11. 17 CFR 3.33 - Withdrawal from registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... REGISTRATION Registration § 3.33 Withdrawal from registration. (a) A futures commission merchant, retail..., retail foreign exchange dealer, introducing broker, commodity trading advisor, commodity pool operator... such activities: (i) That all customer, retail forex customer or option customer agreements, if...

  12. Rationale, design and methods for a randomised and controlled trial to investigate whether home access to electronic games decreases children's physical activity

    PubMed Central

    Straker, Leon M; Abbott, Rebecca A; Piek, Jan P; Pollock, Clare M; Davies, Peter S; Smith, Anne J

    2009-01-01

    Background Many children are reported to have insufficient physical activity (PA) placing them at greater risk of poor health outcomes. Participating in sedentary activities such as playing electronic games is widely believed to contribute to less PA. However there is no experimental evidence that playing electronic games reduces PA. There is also no evidence regarding the effect of different types of electronic games (traditional sedentary electronic games versus new active input electronic games) on PA. Further, there is a poor understanding about how characteristics of children may moderate the impact of electronic game access on PA and about what leisure activities are displaced when children play electronic games. Given that many children play electronic games, a better understanding of the effect of electronic game use on PA is critical to inform child health policy and intervention. Methods This randomised and controlled trial will examine whether PA is decreased by access to electronic games and whether any effect is dependent on the type of game input or the child's characteristics. Children aged 10–12 years (N = 72, 36 females) will be recruited and randomised to a balanced ordering of 'no electronic games', 'traditional' electronic games and 'active' electronic games. Each child will participate in each condition for 8 weeks, and be assessed prior to participation and at the end of each condition. The primary outcome is PA, assessed by Actical accelerometers worn for 7 days on the wrist and hip. Energy expenditure will be assessed by the doubly labelled water technique and motor coordination, adiposity, self-confidence, attitudes to technology and PA and leisure activities will also be assessed. A sample of 72 will provide a power of > 0.9 for detecting a 15 mins difference in PA (sd = 30 mins). Discussion This is the first such trial and will provide critical information to understand whether access to electronic games affects children's PA. Given the

  13. Patient choice in opt-in, active choice, and opt-out HIV screening: randomized clinical trial

    PubMed Central

    Dow, William H; Kaplan, Beth C

    2016-01-01

    preferences. Opt-out regimens can substantially increase HIV testing, and opt-in schemes may reduce testing, compared with active choice testing. Funding, competing interests, data sharing This study was supported by grant NIA 1RC4AG039078 from the National Institute on Aging. The full dataset is available from the corresponding author. Consent for data sharing was not obtained, but the data are anonymized and risk of identification is low. Trial registration Clinical trials NCT01377857. PMID:26786744

  14. Physical Activity, Weight Control, and Breast Cancer Risk and Survival: Clinical Trial Rationale and Design Considerations

    PubMed Central

    Hunsberger, Sally; Alciati, Marianne H.; Blair, Steven N.; Goodwin, Pamela J.; McTiernan, Anne; Wing, Rena; Schatzkin, Arthur

    2009-01-01

    Substantial observational epidemiological evidence exists that physical activity and weight control are associated with decreased risk of postmenopausal breast cancer. Uncertainty remains regarding several aspects of these associations, including the effect of possible confounding factors on these associations. We present the rationale and design for two randomized controlled trials that can help resolve this uncertainty. In a 5-year prevention trial conducted among women at high risk of breast cancer, the primary endpoint would be breast cancer incidence. For a comparable survivorship trial, the primary endpoint would be the disease-free interval and secondary endpoints would be breast cancer recurrence–free interval, second primary breast cancer, and total invasive plus in situ breast cancer. A set of inclusion and exclusion criteria is proposed for both trials. Intervention goals are the same for both trials. Goals for the weight control intervention would be, for women whose body mass index (BMI) is greater than 25 kg/m2, to lose 10% of body weight and, for women whose BMI is less than or equal to 25 kg/m2, to avoid weight gain. The goal for the physical activity intervention would be to achieve and maintain regular participation in a moderate-intensity physical activity program for a total of 150–225 minutes over at least 5 days per week. Sample size calculations are based on alternative assumptions about hazard ratio, adherence, follow-up duration, and power and are presented for the primary prevention and survivorship trials. Although both studies could enhance our understanding of breast cancer etiology and benefit public health, practical considerations, including smaller sample size, ease of recruitment, and reduced likelihood of early termination, favor the survivorship trial at this time. PMID:19401543

  15. Automated Personalized Feedback for Physical Activity and Dietary Behavior Change With Mobile Phones: A Randomized Controlled Trial on Adults

    PubMed Central

    Pfammatter, Angela; Zhang, Mi; Spring, Bonnie; Choudhury, Tanzeem

    2015-01-01

    app over 3 weeks. Daily activity level and dietary intake was monitored from logged data. At the end of the study, an in-person survey was conducted that asked users to subjectively rate their intention to follow MyBehavior suggestions. Results In qualitative daily diary, interview, and survey data, users reported MyBehavior suggestions to be highly actionable and stated that they intended to follow the suggestions. MyBehavior users walked significantly more than the control group over the 3 weeks of the study (P=.05). Although some MyBehavior users chose lower-calorie foods, the between-group difference was not significant (P=.15). In a poststudy survey, users rated MyBehavior’s personalized suggestions more positively than the nonpersonalized, generic suggestions created by professionals (P<.001). Conclusions MyBehavior is a simple-to-use mobile phone app with preliminary evidence of efficacy. To the best of our knowledge, MyBehavior represents the first attempt to create personalized, contextualized, actionable suggestions automatically from self-tracked information (ie, manual food logging and automatic tracking of activity). Lessons learned about the difficulty of manual logging and usability concerns, as well as future directions, are discussed. Trial Registration ClinicalTrials.gov NCT02359981; https://clinicaltrials.gov/ct2/show/NCT02359981 (Archived by WebCite at http://www.webcitation.org/6YCeoN8nv). PMID:25977197

  16. 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…

  17. Physiotherapy to improve physical activity in community-dwelling older adults with mobility problems (Coach2Move): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Older adults can benefit from physical activity in numerous ways. Physical activity is considered to be one of the few ways to influence the level of frailty. Standardized exercise programs do not necessarily lead to more physical activity in daily life, however, and a more personalized approach seems appropriate. The main objective of this study is to investigate whether a focused, problem-oriented coaching intervention (‘Coach2Move’) delivered by a physiotherapist specializing in geriatrics is more effective for improving physical activity, mobility and health status in community-dwelling older adults than usual physiotherapy care. In addition, cost-effectiveness will be determined. Methods/Design The design of this study is a single-blind randomized controlled trial in thirteen physiotherapy practices. Randomization will take place at the individual patient level. The study population consists of older adults, ≥70 years of age, with decreased physical functioning and mobility and/or a physically inactive lifestyle. The intervention group will receive geriatric physiotherapy according to the Coach2Move strategy. The control group will receive the usual physiotherapy care. Measurements will be performed by research assistants not aware of group assignment. The results will be evaluated on the amount of physical activity (LASA Physical Activity Questionnaire), mobility (modified ‘get up and go’ test, walking speed and six-minute walking test), quality of life (SF-36), degree of frailty (Evaluative Frailty Index for Physical Activity), fatigue (NRS-fatigue), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire) and health care costs. Discussion Most studies on the effect of exercise or physical activity consist of standardized programs. In this study, a personalized approach is evaluated within a group of frail older adults, many of whom suffer from multiple and complex diseases and problems. A complicating

  18. Recruitment and Enrollment of Caregivers for a Lifestyle Physical Activity Clinical Trial

    PubMed Central

    Etkin, Caryn D.; Farran, Carol J.; Barnes, Lisa L.; Shah, Raj C.

    2013-01-01

    This paper presents the efficacy of the recruitment framework used for a clinical trial with sedentary family caregivers of persons with Alzheimer’s disease. An integrated social marketing approach with principles of community-based participatory research provided the theoretical framework for organizing recruitment activities. This multi-pronged approach meant that caregivers were identified from a range of geographic locations and numerous sources including a federally funded Alzheimer’s disease center, health care providers, community based and senior organizations, and broad-based media. Study enrollment projections were exceeded by 11% and resulted in enrolling N = 211 caregivers into this clinical trial. We conclude that social marketing and community-based approaches provide a solid foundation for organizing recruitment activities for clinical trials with older adults. PMID:22083931

  19. Recruitment and enrollment of caregivers for a lifestyle physical activity clinical trial.

    PubMed

    Etkin, Caryn D; Farran, Carol J; Barnes, Lisa L; Shah, Raj C

    2012-02-01

    This article presents the efficacy of the recruitment framework used for a clinical trial with sedentary family caregivers of persons with Alzheimer's disease. An integrated social marketing approach with principles of community-based participatory research provided the theoretical framework for organizing recruitment activities. This multi-pronged approach meant that caregivers were identified from a range of geographic locations and numerous sources including a federally funded Alzheimer's disease center, health care providers, community based and senior organizations, and broad-based media. Study enrollment projections were exceeded by 11% and resulted in enrolling n = 211 caregivers into this clinical trial. We conclude that social marketing and community-based approaches provide a solid foundation for organizing recruitment activities for clinical trials with older adults. PMID:22083931

  20. 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...

  1. 75 FR 80490 - Pesticide Products; Registration Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

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

  2. 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...

  3. 75 FR 19388 - Pesticide Product; Registration Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ... 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 ingredient not included in any previously registered pesticide products. Pursuant to the provisions...

  4. 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.

  5. 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

  6. 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…

  7. 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…

  8. 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

  9. A trial-by-trial analysis reveals more intense physical activity is associated with better cognitive control performance in attention-deficit/hyperactivity disorder.

    PubMed

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

    2016-01-01

    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 a 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 group but not in the 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.

  10. 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

  11. Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial

    PubMed Central

    2011-01-01

    Standard Care group. Conclusions Continuous self-monitoring from wearable technology with real-time feedback may be particularly useful to enhance lifestyle changes that promote weight loss in sedentary overweight or obese adults. This strategy, combined with a group-based behavioral intervention, may yield optimal weight loss. Trial Registration ClinicalTrials.gov: NCT00957008 PMID:21592351

  12. 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

  13. 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

  14. 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

  15. 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

    ... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Approval of registration under FIFRA... of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION... not significantly increase the risk of any unreasonable adverse effect on the environment; and (3)...

  16. 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

    ... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Approval of registration under FIFRA... of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION... not significantly increase the risk of any unreasonable adverse effect on the environment; and (3)...

  17. 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

    ... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Approval of registration under FIFRA... of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION... not significantly increase the risk of any unreasonable adverse effect on the environment; and (3)...

  18. Antiretroviral effect of lovastatin on HIV-1-infected individuals without highly active antiretroviral therapy (The LIVE study): a phase-II randomized clinical trial

    PubMed Central

    Montoya, Carlos J; Jaimes, Fabian; Higuita, Edwin A; Convers-Páez, Sandra; Estrada, Santiago; Gutierrez, Francisco; Amariles, Pedro; Giraldo, Newar; Peñaloza, Cristina; Rugeles, Maria T

    2009-01-01

    Background Highly active antiretroviral therapy produces a significant decrease in HIV-1 replication and allows an increase in the CD4 T-cell count, leading to a decrease in the incidence of opportunistic infections and mortality. However, the cost, side effects and complexity of antiretroviral regimens have underscored the immediate need for additional therapeutic approaches. Statins exert pleiotropic effects through a variety of mechanisms, among which there are several immunoregulatory effects, related and unrelated to their cholesterol-lowering activity that can be useful to control HIV-1 infection. Methods/design Randomized, double-blinded, placebo controlled, single-center, phase-II clinical trial. One hundred and ten chronically HIV-1-infected patients, older than 18 years and naïve for antirretroviral therapy (i.e., without prior or current management with antiretroviral drugs) will be enrolled at the outpatient services from the most important centres for health insurance care in Medellin-Colombia. The interventions will be lovastatin (40 mg/day, orally, for 12 months; 55 patients) or placebo (55 patients). Our primary aim will be to determine the effect of lovastatin on viral replication. The secondary aim will be to determine the effect of lovastatin on CD4+ T-cell count in peripheral blood. As tertiary aims we will explore differences in CD8+ T-cell count, expression of activation markers (CD38 and HLA-DR) on CD4 and CD8 T cells, cholesterol metabolism, LFA-1/ICAM-1 function, Rho GTPases function and clinical evolution between treated and not treated HIV-1-infected individuals. Discussion Preliminary descriptive studies have suggested that statins (lovastatin) may have anti HIV-1 activity and that their administration is safe, with the potential effect of controlling HIV-1 replication in chronically infected individuals who had not received antiretroviral medications. Considering that there is limited clinical data available on this topic, all these

  19. Variability of single trial brain activation predicts fluctuations in reaction time.

    PubMed

    Bender, Stephan; Banaschewski, Tobias; Roessner, Veit; Klein, Christoph; Rietschel, Marcella; Feige, Bernd; Brandeis, Daniel; Laucht, Manfred

    2015-03-01

    Brain activation stability is crucial to understanding attention lapses. EEG methods could provide excellent markers to assess neuronal response variability with respect to temporal (intertrial coherence) and spatial variability (topographic consistency) as well as variations in activation intensity (low frequency variability of single trial global field power). We calculated intertrial coherence, topographic consistency and low frequency amplitude variability during target P300 in a continuous performance test in 263 15-year-olds from a cohort with psychosocial and biological risk factors. Topographic consistency and low frequency amplitude variability predicted reaction time fluctuations (RTSD) in a linear model. Higher RTSD was only associated with higher psychosocial adversity in the presence of the homozygous 6R-10R dopamine transporter haplotype. We propose that topographic variability of single trial P300 reflects noise as well as variability in evoked cortical activation patterns. Dopaminergic neuromodulation interacted with environmental and biological risk factors to predict behavioural reaction time variability.

  20. 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. PMID:22566517

  1. 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

  2. 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

  3. Kinematic Analysis of Healthy Hips during Weight-Bearing Activities by 3D-to-2D Model-to-Image Registration Technique

    PubMed Central

    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. PMID:25506056

  4. The sydney playground project: popping the bubblewrap - unleashing the power of play: a cluster randomized controlled trial of a primary school playground-based intervention aiming to increase children's physical activity and social skills

    PubMed Central

    2011-01-01

    Background In the Westernised world, numerous children are overweight and have problems with bullying and mental health. One of the underlying causes for all three is postulated to be a decrease in outdoor free play. The aim of the Sydney Playground Project is to demonstrate the effectiveness of two simple interventions aimed to increase children's physical activity and social skills. Methods/Design This study protocol describes the design of a 3-year cluster randomised controlled trial (CRCT), in which schools are the clusters. The study consists of a 13-week intervention and 1 week each of pre-and post-testing. We are recruiting 12 schools (6 control; 6 intervention), with 18 randomly chosen participants aged 5 to 7 years in each school. The two intervention strategies are: (1) Child-based intervention: Unstructured materials with no obvious play value introduced to the playground; and (2) Adult-based intervention: Risk reframing sessions held with parents and teachers with the aim of exploring the benefits of allowing children to engage in activities with uncertain outcomes. The primary outcome of the study, physical activity as measured by accelerometer counts, is assessed at baseline and post-intervention. Additional assessments include social skills and interactions, self-concept, after school time use and anthropometric data. Qualitative data (i.e., transcriptions of audio recordings from the risk reframing sessions and of interviews with selected teacher and parent volunteers) are analysed to understand their perceptions of risk in play. The control schools have recess as usual. In addition to outcome evaluation, regular process evaluation sessions are held to monitor fidelity to the treatment. Discussion These simple interventions, which could be adopted in every primary school, have the potential of initiating a self-sustaining cycle of prevention for childhood obesity, bullying and mental ill health. Trial registration Australian and New Zealand Clinical

  5. A non-pharmacologic approach to address challenging behaviors of Veterans with dementia: description of the tailored activity program-VA randomized trial

    PubMed Central

    2013-01-01

    impact of Veterans Administration cost is also examined. Study precision will be increased through face-to-face research team trainings with procedural manuals and review of audio-taped interviews and intervention sessions. Discussion The Tailored Activity Program – Veterans Administration is designed to improve the quality of life of Veterans with dementia and lessen the burden of care on caregivers. Activities are tailored to reflect the Veteran’s preserved capabilities and interests to enhance active engagement, while not taxing areas of cognition that are most impaired. Trial registration ClinicalTrials.gov, NCT01357564 PMID:24060106

  6. Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children’s body mass index

    PubMed Central

    2014-01-01

    trained child health professionals such as child care health consultants, increases provider knowledge, improves center policies, and lowers BMI for children in child care centers. More health professionals specifically trained in a nutrition and physical activity intervention in child care are needed to help reverse the obesity epidemic. Trial registration National Clinical Trials Number NCT01921842 PMID:24580983

  7. Would Older Adults with Mild Cognitive Impairment Adhere to and Benefit from a Structured Lifestyle Activity Intervention to Enhance Cognition?: A Cluster Randomized Controlled Trial

    PubMed Central

    Lam, Linda Chiu-wa; Chan, Wai Chi; Leung, Tony; Fung, Ada Wai-tung; Leung, Edward Man-fuk

    2015-01-01

    Structured lifestyle activity interventions were not associated with changes in everyday functioning, albeit with some improvements in cognitive scores across time. Higher adherence was associated with greater improvement in cognitive scores. Factors to enhance adherence should be specially considered in the design of psychosocial interventions for older adults with cognitive decline. Trial Registration ClinicalTrials.gov ChiCTR-TRC-11001359 PMID:25826620

  8. 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

  9. 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

  10. 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

  11. 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

  12. A double-blind placebo-controlled trial of methylprednisolone pulse therapy in active rheumatoid disease.

    PubMed

    Williams, I A; Baylis, E M; Shipley, M E

    1982-07-31

    To confirm the findings of uncontrolled trials that methylprednisolone pulse therapy (MPPT) is a safe treatment for active rheumatoid disease, a double-blind trial was conducted in which 20 patients with active rheumatoid disease were randomly allocated to receive an infusion of either 1 g methylprednisolone or placebo. Methylprednisolone produced significant improvement in all clinical variables measured, a benefit which was sustained for at least 6 weeks. The placebo produced only transient improvement in some of the clinical variables measured. when the 10 placebo groups patients were later given an infusion of 1 g methylprednisolone, they too showed significant clinical benefit. The methylprednisolone also gave rise to improvements in some haematological and biochemical variables. PMID:6124671

  13. WALK 2.0: Examining the effectiveness of Web 2.0 features to increase physical activity in a ‘real world’ setting: an ecological trial

    PubMed Central

    Caperchione, Cristina M; Kolt, Gregory S; Savage, Trevor N; Rosenkranz, Richard R; Maeder, Anthony J; Vandelanotte, Corneel; Duncan, Mitch J; Van Itallie, Anetta; Tague, Rhys; Mummery, W Kerry

    2014-01-01

    Introduction Low levels of health-enhancing physical activity require novel approaches that have the potential to reach broad populations. Web-based interventions are a popular approach for behaviour change given their wide reach and accessibility. However, challenges with participant engagement and retention reduce the long-term maintenance of behaviour change. Web 2.0 features present a new and innovative online environment supporting greater interactivity, with the potential to increase engagement and retention. In order to understand the applicability of these innovative interventions for the broader population, ‘real-world’ interventions implemented under ‘everyday conditions’ are required. The aim of this study is to investigate the difference in physical activity behaviour between individuals using a traditional Web 1.0 website with those using a novel Web 2.0 website. Methods and analysis In this study we will aim to recruit 2894 participants. Participants will be recruited from individuals who register with a pre-existing health promotion website that currently provides Web 1.0 features (http://www.10000steps.org.au). Eligible participants who provide informed consent will be randomly assigned to one of the two trial conditions: the pre-existing 10 000 Steps website (with Web 1.0 features) or the newly developed WALK 2.0 website (with Web 2.0 features). Primary and secondary outcome measures will be assessed by self-report at baseline, 3 months and 12 months, and include: physical activity behaviour, height and weight, Internet self-efficacy, website usability, website usage and quality of life. Ethics and dissemination This study has received ethics approval from the University of Western Sydney Human Research Ethics Committee (Reference Number H8767) and has been funded by the National Health and Medical Research Council (Reference Number 589903). Study findings will be disseminated widely through peer-reviewed publications, academic

  14. 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

  15. Effect of different aerodynamic time trial cycling positions on muscle activation and crank torque.

    PubMed

    Fintelman, D M; Sterling, M; Hemida, H; Li, F-X

    2016-05-01

    To reduce air resistance, time trial cyclists and triathletes lower their torso angle. The aim of this study was to investigate the effect of lowering time trial torso angle positions on muscle activation patterns and crank torque coordination. It was hypothesized that small torso angles yield a forward shift of the muscle activation timing and crank torque. Twenty-one trained cyclists performed three exercise bouts at 70% maximal aerobic power in a time trial position at three different torso angles (0°, 8°, and 16°) at a fixed cadence of 85 rpm. Measurements included surface electromyography, crank torques and gas exchange. A significant increase in crank torque range and forward shift in peak torque timing was found at smaller torso angles. This relates closely with the later onset and duration of the muscle activation found in the gluteus maximus muscle. Torso angle effects were only observed in proximal monoarticular muscles. Moreover, all measured physiological variables (oxygen consumption, breathing frequency, minute ventilation) were significantly increased with lowering torso angle and hence decreased the gross efficiency. The findings provide support for the notion that at a cycling intensity of 70% maximal aerobic power, the aerodynamic gains outweigh the physiological/biomechanical disadvantages in trained cyclists.

  16. Subconjunctival Sirolimus for the Treatment of Chronic Active Anterior Uveitis: Results of a Pilot Trial

    PubMed Central

    Sen, H. Nida; Larson, Theresa A.; Meleth, Annal D.; Smith, Wendy M.; Nussenblatt, Robert B.

    2012-01-01

    Purpose To evaluate the safety and possible efficacy of subconjunctival sirolimus for the treatment of chronic active anterior uveitis Design Prospective, non-randomized, open-label clinical trial. Methods This single-center pilot trial enrolled 5 patients with chronic active anterior uveitis. The study drug was administered as single subconjunctival injection of 30μL (1,320μg) sirolimus in the study eye at the baseline visit. Study visits were performed at baseline, 2 weeks, 4 weeks and monthly until 4 months, and included a complete ophthalmic exam, review of systems, adverse event assessment at each visit, physical exam and ancillary ophthalmic testing at some visits. The primary outcome measure was a 2-step reduction in the anterior chamber inflammation within 4 weeks of injection of the study drug. Results There were 3 females and 2 males; 4 patients had idiopathic anterior uveitis and one had psoriatic arthritis-associated anterior uveitis. Three of the five patients met the primary outcome criteria by showing at least a 2-step decrease in inflammation within 4 weeks, 2 patients showed a 1-step decrease in inflammation within the same time frame. No recurrence was encountered during a 4 month follow-up. There were no serious adverse events. Conclusions Subconjunctival sirolimus appears to be well tolerated in this pilot trial and shows promise as a treatment for active inflammation in patients with chronic anterior uveitis. Larger studies are needed to assess its usefulness in uveitis. PMID:22465364

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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

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

    PubMed Central

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

    2016-01-01

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

  5. 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

  6. It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial

    PubMed Central

    Spreeuwenberg, Marieke; Tange, Huibert; van der Weijden, Trudy; de Witte, Luc

    2015-01-01

    Background Physical inactivity is a major public health problem. The It’s LiFe! monitoring and feedback tool embedded in the Self-Management Support Program (SSP) is an attempt to stimulate physical activity in people with chronic obstructive pulmonary disease or type 2 diabetes treated in primary care. Objective Our aim was to evaluate whether the SSP combined with the use of the monitoring and feedback tool leads to more physical activity compared to usual care and to evaluate the additional effect of using this tool on top of the SSP. Methods This was a three-armed cluster randomised controlled trial. Twenty four family practices were randomly assigned to one of three groups in which participants received the tool + SSP (group 1), the SSP (group 2), or care as usual (group 3). The primary outcome measure was minutes of physical activity per day. The secondary outcomes were general and exercise self-efficacy and quality of life. Outcomes were measured at baseline after the intervention (4-6 months), and 3 months thereafter. Results The group that received the entire intervention (tool + SSP) showed more physical activity directly after the intervention than Group 3 (mean difference 11.73, 95% CI 6.21-17.25; P<.001), and Group 2 (mean difference 7.86, 95% CI 2.18-13.54; P=.003). Three months after the intervention, this effect was still present and significant (compared to Group 3: mean difference 10.59, 95% CI 4.94-16.25; P<.001; compared to Group 2: mean difference 9.41, 95% CI 3.70-15.11; P<.001). There was no significant difference in effect between Groups 2 and 3 on both time points. There was no interaction effect for disease type. Conclusions The combination of counseling with the tool proved an effective way to stimulate physical activity. Counseling without the tool was not effective. Future research about the cost-effectiveness and application under more tailored conditions and in other target groups is recommended. Trial Registration ClinicalTrials

  7. AVERT2 (a very early rehabilitation trial, a very effective reproductive trigger): retrospective observational analysis of the number of babies born to trial staff

    PubMed Central

    Lindley, Richard I; Lalor, Erin; Ellery, Fiona; Chamberlain, Jan; Van Holsteyn, John; Collier, Janice M; Dewey, Helen M; Parsons, Brooke; Moodie, Marjory; Lennon, Sheila; Donnan, Geoffrey A; Thrift, Amanda G; Churilov, Leonid; Langhorne, Peter

    2015-01-01

    Objective To report the number of participants needed to recruit per baby born to trial staff during AVERT, a large international trial on acute stroke, and to describe trial management consequences. Design Retrospective observational analysis. Setting 56 acute stroke hospitals in eight countries. Participants 1074 trial physiotherapists, nurses, and other clinicians. Outcome measures Number of babies born during trial recruitment per trial participant recruited. Results With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average. Conclusion The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators’ meetings and helped maintain a cohesive collaborative group. Trial registration Australian New Zealand Clinical Trials Registry no 12606000185561. Disclaimer Participation in a rehabilitation trial does not guarantee successful reproductive activity. PMID:26658193

  8. Association of a multibiomarker disease activity score at multiple time-points with radiographic progression in rheumatoid arthritis: results from the SWEFOT trial

    PubMed Central

    Hambardzumyan, Karen; Bolce, Rebecca J; Saevarsdottir, Saedis; Forslind, Kristina; Wallman, Johan K; Cruickshank, Scott E; Sasso, Eric H; Chernoff, David; van Vollenhoven, Ronald F

    2016-01-01

    Objectives In rheumatoid arthritis (RA), predictive biomarkers for subsequent radiographic progression (RP) could improve therapeutic choices for individual patients. We previously showed that the multibiomarker disease activity (MBDA) score in patients with newly diagnosed RA identified patients at risk for RP. We evaluated the MBDA score at multiple time-points as a predictor of RP during 2 years of follow-up. Methods A subset of patients with RA (N=220) from the Swedish Farmacotherapy (SWEFOT) trial were analysed for MBDA score, disease activity score of 28 joints (DAS28), C reactive protein (CRP) and erythrocyte sedimentation rate (ESR) at baseline (BL), month 3 and year 1, for predicting RP based on modified Sharp/van der Heijde scores at BL, year 1 and year 2. Results Patients with persistently low MBDA (<30) scores or those with a decrease from moderate (30–44) to low MBDA scores, did not develop RP during 2 years of follow-up. The highest risk for RP during 2 years of follow-up (42%) was observed among patients with persistently high (>44) MBDA scores. Among methotrexate non-responders with a high MBDA score at BL or month 3, significantly more of those who received triple therapy had RP at year 2 compared with those who received antitumour necrosis factor therapy. Conclusions Measuring the MBDA score both before and during treatment in RA was useful for the assessment of individual patient risk for RP during 2 years of follow-up. In comparison with low CRP, ESR or DAS28, a low MBDA score at any time-point was associated with numerically lower proportions of RP. Trial registration number NCT00764725. PMID:26958364

  9. 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

  10. 11 CFR 100.149 - Voter registration and get-out-the-vote activities for Presidential candidates.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., billboard, direct mail, or similar type of general public communication or political advertising. For... conditions are met: (a) Exemption not applicable to general public communication or political advertising... Act. But see 11 CFR 100.24, 104.17(a), and part 300, subpart B for exempt activities that...

  11. Antidepressant Efficacy of Adjunctive Aerobic Activity and Associated Biomarkers in Major Depression: A 4-Week, Randomized, Single-Blind, Controlled Clinical Trial

    PubMed Central

    Siqueira, Cristiana Carvalho; Valiengo, Leandro L.; Carvalho, André F.; Santos-Silva, Paulo Roberto; Missio, Giovani; de Sousa, Rafael T.; Di Natale, Georgia; Gattaz, Wagner F.; Moreno, Ricardo Alberto; Machado-Vieira, Rodrigo

    2016-01-01

    Background Major depressive disorder (MDD) is a highly prevalent, heterogeneous and systemic medical condition. Treatment options are limited, and recent studies have suggested that physical exercise can play an important role in the therapeutics of MDD. The aim of this study was to evaluate the antidepressant efficacy of adjunctive aerobic activity in association with pharmacotherapy (selective serotonin reuptake inhibitor) in symptomatic MDD as well as its association with physiological biomarkers. Methods In this randomized, single-blind, add-on, controlled clinical trial, 57 patients (18–55 years of age) were followed-up for 28 days. All patients were drug-free, had been diagnosed with symptomatic MDD and received flexible dose of sertraline during the trial. Patients were randomized to either a 4-week program (4x/week) of add-on aerobic exercise (exercise group, N = 29) or no activity (control group, N = 28). Depression severity was assessed using the Hamilton Rating Scale for Depression (HAM-D) as the primary outcome. At baseline and endpoint, all patients underwent a comprehensive metabolic/cardiopulmonary exercise testing—including determination of maximal oxygen uptake (VO2max), VO2 at the second ventilatory threshold (VO2-VT2), and oxygen pulse (O2 pulse). Results Depression scores significantly decreased in both groups after intervention. Importantly, patients in the aerobic exercise group required lower sertraline dose compared to the control group (sertraline monotherapy). The VO2max and O2 pulse parameters increased over time only in the exercise group and remained unchanged in the control group. Conclusions The present findings suggest that a 4-week training of aerobic exercise significantly improves functional capacity in patients with MDD and may be associated with antidepressant efficacy. This approach may also decrease the need for higher doses of antidepressants to achieve response. Further studies in unmedicated and treatment-resistant MDD

  12. Measurement of neutron spectra in varied environments by the foil-activation method with arbitrary trials

    SciTech Connect

    Kelly, J.G.; Vehar, D.W.

    1987-12-01

    Neutron spectra have been measured by the foil-activation method in 13 different environments in and around the Sandia Pulsed Reactor, the White Sands Missile Range Fast Burst Reactor, and the Sandia Annular Core Research Reactor. The spectra were obtained by using the SANDII code in a manner that was not dependent on the initial trial. This altered technique is better suited for the determination of spectra in environments that are difficult to predict by calculation, and it tends to reveal features that may be biased out by the use of standard trial-dependent methods. For some of the configurations, studies have also been made of how well the solution is determined in each energy region. The experimental methods and the techniques used in the analyses are thoroughly explained. 34 refs., 51 figs., 40 tabs.

  13. Automatic parameter selection for multimodal image registration.

    PubMed

    Hahn, Dieter A; Daum, Volker; Hornegger, Joachim

    2010-05-01

    Over the past ten years similarity measures based on intensity distributions have become state-of-the-art in automatic multimodal image registration. An implementation for clinical usage has to support a plurality of images. However, a generally applicable parameter configuration for the number and sizes of histogram bins, optimal Parzen-window kernel widths or background thresholds cannot be found. This explains why various research groups present partly contradictory empirical proposals for these parameters. This paper proposes a set of data-driven estimation schemes for a parameter-free implementation that eliminates major caveats of heuristic trial and error. We present the following novel approaches: a new coincidence weighting scheme to reduce the influence of background noise on the similarity measure in combination with Max-Lloyd requantization, and a tradeoff for the automatic estimation of the number of histogram bins. These methods have been integrated into a state-of-the-art rigid registration that is based on normalized mutual information and applied to CT-MR, PET-MR, and MR-MR image pairs of the RIRE 2.0 database. We compare combinations of the proposed techniques to a standard implementation using default parameters, which can be found in the literature, and to a manual registration by a medical expert. Additionally, we analyze the effects of various histogram sizes, sampling rates, and error thresholds for the number of histogram bins. The comparison of the parameter selection techniques yields 25 approaches in total, with 114 registrations each. The number of bins has no significant influence on the proposed implementation that performs better than both the manual and the standard method in terms of acceptance rates and target registration error (TRE). The overall mean TRE is 2.34 mm compared to 2.54 mm for the manual registration and 6.48 mm for a standard implementation. Our results show a significant TRE reduction for distortion

  14. Protocol for an economic evaluation alongside the University Health Network Whiplash Intervention Trial: cost-effectiveness of education and activation, a rehabilitation program, and the legislated standard of care for acute whiplash injury in Ontario

    PubMed Central

    2011-01-01

    Background Whiplash injury affects 83% of persons in a traffic collision and leads to whiplash-associated disorders (WAD). A major challenge facing health care decision makers is identifying cost-effective interventions due to lack of economic evidence. Our objective is to compare the cost-effectiveness of: 1) physician-based education and activation, 2) a rehabilitation program developed by Aviva Canada (a group of property and casualty insurance providers), and 3) the legislated standard of care in the Canadian province of Ontario: the Pre-approved Framework Guideline for Whiplash developed by the Financial Services Commission of Ontario. Methods/Design The economic evaluation will use participant-level data from the University Health Network Whiplash Intervention Trial and will be conducted from the societal perspective over the trial's one-year follow-up. Resource use (costs) will include all health care goods and services, and benefits provided during the trial's 1-year follow-up. The primary health effect will be the quality-adjusted life year. We will identify the most cost-effective intervention using the incremental cost-effectiveness ratio and incremental net-benefit. Confidence ellipses and cost-effectiveness acceptability curves will represent uncertainty around these statistics, respectively. A budget impact analysis will assess the total annual impact of replacing the current legislated standard of care with each of the other interventions. An expected value of perfect information will determine the maximum research expenditure Canadian society should be willing to pay for, and inform priority setting in, research of WAD management. Discussion Results will provide health care decision makers with much needed economic evidence on common interventions for acute whiplash management. Trial Registration http://ClinicalTrials.gov identifier NCT00546806 [Trial registry date: October 18, 2007; Date first patient was randomized: February 27, 2008] PMID

  15. Efficacy of graded activity versus supervised exercises in patients with chronic non-specific low back pain: protocol of a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Low back pain is a relevant public health problem, being an important cause of work absenteeism worldwide, as well as affecting the quality of life of sufferers and their individual functional performances. Supervised active physical routines and of cognitive-behavioral therapies are recommended for the treatment of chronic Low back pain, although evidence to support the effectiveness of different techniques is missing. Accordingly, the aim of this study is to contrast the effectiveness of two types of exercises, graded activity or supervised, in decreasing symptoms of chronic low back pain. Methods/design Sample will consist of 66 patients, blindly allocated into one of two groups: 1) Graded activity which, based on an operant approach, will use time-contingent methods aiming to increase participants’ activity levels; 2) Supervised exercise, where participants will be trained for strengthening, stretching, and motor control targeting different muscle groups. Interventions will last one hour, and will happen twice a week for 6 weeks. Outcomes (pain, disability, quality of life, global perceived effect, return to work, physical activity, physical capacity, and kinesiophobia) will be assessed at baseline, at treatment end, and three and six months after treatment end. Data collection will be conducted by an investigator blinded to treatment allocation. Discussion This project describes the randomisation method that will be used to compare the effectiveness of two different treatments for chronic low back pain: graded activity and supervised exercises. Since optimal approach for patients with chronic back pain have yet not been defined based on evidence, good quality studies on the subject are necessary. Trial registration NCT01719276 PMID:23336703

  16. A school-based intervention to promote physical activity among adolescent girls: Rationale, design, and baseline data from the Girls in Sport group randomised controlled trial

    PubMed Central

    2011-01-01

    promoting and sustaining increased physical activity participation among adolescent girls. Trial Registration Number Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610001077055 PMID:21854609

  17. 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,...

  18. “Not just another walking program”: Everyday Activity Supports You (EASY) model—a randomized pilot study for a parallel randomized controlled trial

    PubMed Central

    Ashe, Maureen C; Winters, Meghan; Hoppmann, Christiane A; Dawes, Martin G; Gardiner, Paul A; Giangregorio, Lora M; Madden, Kenneth M; McAllister, Megan M; Wong, Gillian; Puyat, Joseph H; Singer, Joel; Sims-Gould, Joanie; McKay, Heather A

    2016-01-01

    average between group difference in weight loss of −4.3 [95% CI −6.22, −2.40] kg and reduction in diastolic blood pressure of −8.54 [95% CI −16.89, −0.198] mmHg, in favor of EASY. Conclusions The EASY pilot study was feasible to deliver; there was an increase in physical activity and reduction in weight and blood pressure for intervention participants at 6 months. Trial registration ClinicalTrials.gov identifier: NCT01842061 PMID:27175291

  19. 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.

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

    PubMed

    Ohata, Ryu; Ogawa, Kenji; Imamizu, Hiroshi

    2016-06-02

    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.

  1. 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

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

    PubMed

    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

  3. Project Zero Delay: a process for accelerating the activation of cancer clinical trials.

    PubMed

    Kurzrock, Razelle; Pilat, Susan; Bartolazzi, Marcel; Sanders, Dwana; Van Wart Hood, Jill; Tucker, Stanley D; Webster, Kevin; Mallamaci, Michael A; Strand, Steven; Babcock, Eileen; Bast, Robert C

    2009-09-10

    Drug development in cancer research is lengthy and expensive. One of the rate-limiting steps is the initiation of first-in-human (phase I) trials. Three to 6 months can elapse between investigational new drug (IND) approval by the US Food and Drug Administration and the entry of a first patient. Issues related to patient participation have been well analyzed, but the administrative processes relevant to implementing clinical trials have received less attention. While industry and academia often partner for the performance of phase I studies, their administrative processes are generally performed independently, and their timelines driven by different priorities: safety reviews, clinical operations, regulatory submissions, and contracting of clinical delivery vendors for industry; contracts, budgets, and institutional review board approval for academia. Both processes converge on US Food and Drug Administration approval of an IND. In the context of a strategic alliance between M. D. Anderson Cancer Center and AstraZeneca Pharmaceuticals LP, a concerted effort has been made to eliminate delays in implementing clinical trials. These efforts focused on close communications, identifying and matching key timelines, alignment of priorities, and tackling administrative processes in parallel, rather than sequentially. In a recent, first-in-human trial, the study was activated and the first patient identified in 46 days from completion of the final study protocol and about 48 hours after final US Food and Drug Administration IND approval, reducing the overall timeline by about 3 months, while meeting all clinical good practice guidelines. Eliminating administrative delays can accelerate the evaluation of new drugs without compromising patient safety or the quality of clinical research. PMID:19652061

  4. Rationale, design and methods for a randomised and controlled trial of the impact of virtual reality games on motor competence, physical activity, and mental health in children with developmental coordination disorder

    PubMed Central

    2011-01-01

    virtual reality games on motor coordination in children with developmental coordination disorder. The findings will provide critical information to understand whether these electronic games can be used to have a positive impact on the physical and mental health of these children. Given the importance of adequate motor coordination, physical activity and mental health in childhood, this project can inform interventions which could have a profound impact on the long term health of this group of children. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000400965 PMID:21851587

  5. Manual therapy followed by specific active exercises versus a placebo followed by specific active exercises on the improvement of functional disability in patients with chronic non specific low back pain: a randomized controlled trial

    PubMed Central

    2012-01-01

    found in remaining outcomes. Conclusions This study confirmed the immediate analgesic effect of MT over ST. Followed by specific active exercises, it reduces significantly functional disability and tends to induce a larger decrease in pain intensity, compared to a control group. These results confirm the clinical relevance of MT as an appropriate treatment for CNSLBP. Its neurophysiologic mechanisms at cortical level should be investigated more thoroughly. Trial registration Trial registration number: NCT01496144 PMID:22925609

  6. 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

  7. Healthy for Life: A Randomized Trial Examining Physical Activity Outcomes and Psychosocial Mediators

    PubMed Central

    Williams, David M.; Martinson, Brian C.; Dunsiger, Shira; Marcus, Bess H.

    2012-01-01

    Background Researchers theorize that interventions increase physical activity by influencing key theory-based mediators (e.g., behavioral processes). However, few studies have been adequately powered to examine the importance of mediators. Purpose This study examined both physical activity behavior and psychosocial mediators in a randomized trial specifically powered to detect mediation. Methods Healthy, sedentary adults (n=448; 70% Caucasian, 87% women, mean age was 43) were randomly assigned to either a six-month print-based theory tailored physical activity intervention (n=224) or a six-month health/wellness contact control arm (n=224). Results The print intervention arm exhibited greater increases in physical activity than the control arm at six and 12 months (p<.05). Additionally, behavioral processes were found to be an important mediator of physical activity behavior. Conclusions It is important for researchers and practitioners to focus on increasing behavioral strategies for physical activity adoption. Future studies should examine other potential mediators of physical activity. PMID:23229158

  8. 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.

  9. 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

  10. 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.

  11. 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…

  12. 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 registration…

  13. 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…

  14. Two preclinical tests to evaluate anticancer activity and to help validate drug candidates for clinical trials

    PubMed Central

    López-Lázaro, Miguel

    2015-01-01

    Current approaches to assessing preclinical anticancer activity do not reliably predict drug efficacy in cancer patients. Most of the compounds that show remarkable anticancer effects in preclinical models actually fail when tested in clinical trials. We blame these failures on the complexity of the disease and on the limitations of the preclinical tools we require for our research. This manuscript argues that this lack of clinical response may also be caused by poor in vitro and in vivo preclinical designs, in which cancer patients' needs are not fully considered. Then, it proposes two patient-oriented tests to assess in vitro and in vivo anticancer activity and to help validate drug candidates for clinical evaluation. PMID:25859551

  15. Improving physical activity in arthritis clinical trial (IMPAACT): study design, rationale, recruitment, and baseline data.

    PubMed

    Chang, Rowland W; Semanik, Pamela A; Lee, Jungwha; Feinglass, Joseph; Ehrlich-Jones, Linda; Dunlop, Dorothy D

    2014-11-01

    Over 21 million Americans report an arthritis-attributable activity limitation. Knee osteoarthritis (OA) and rheumatoid arthritis (RA) are two of the most common/disabling forms of arthritis. Various forms of physical activity (PA) can improve a variety of health outcomes and reduce health care costs, but the proportion of the US population engaging in the recommended amount of PA is low and even lower among those with arthritis. The Improving Motivation for Physical Activity in Arthritis Clinical Trial (IMPAACT) is a randomized clinical trial that studied the effects of a lifestyle PA promotion intervention on pain and physical function outcomes. The IMPAACT intervention was based on a chronic care/disease management model in which allied health professionals promote patient self-management activities outside of traditional physician office encounters. The program was a motivational interviewing-based, individualized counseling and referral intervention, directed by a comprehensive assessment of individual patient barriers and strengths related to PA performance. The specific aims of IMPAACT were to test the efficacy of the IMPAACT intervention for persons with arthritis (N=185 persons with RA and 155 persons with knee OA) in improving arthritis-specific and generic self-reported pain and Physical Function outcomes, observed measures of function, and objectively measured and self-reported PA levels. Details of the stratified-randomized study design, subject recruitment, and data collection are described. The results from IMPAACT will generate empiric evidence pertaining to increasing PA levels in persons with arthritis and result in widely applicable strategies for health behavior change.

  16. IMPROVING PHYSICAL ACTIVITY IN ARTHRITIS CLINICAL TRIAL (IMPAACT): STUDY DESIGN, RATIONALE, RECRUITMENT, AND BASELINE DATA

    PubMed Central

    Chang, Rowland W.; Semanik, Pamela A.; Lee, Jungwha; Feinglass, Joseph; Ehrlich-Jones, Linda; Dunlop, Dorothy D.

    2014-01-01

    Over 21 million Americans report an arthritis-attributable activity limitation. Knee osteoarthritis (OA) and rheumatoid arthritis (RA) are two of the most common/disabling forms of arthritis. Various forms of physical activity (PA) can improve a variety of health outcomes and reduce health care costs, but the proportion of the US population engaging in the recommended amount of PA is low and even lower among those with arthritis. The Improving Motivation for Physical Activity in Arthritis Clinical Trial (IMPAACT) is a randomized clinical trial that studied the effects of a lifestyle PA promotion intervention on pain and physical function outcomes. The IMPAACT intervention was based on a chronic care/disease management model in which allied health professionals promote patient self-management activities outside of traditional physician office encounters. The program was a motivational interviewing-based, individualized counseling and referral intervention, directed by a comprehensive assessment of individual patient barriers and strengths related to PA performance. The specific aims of IMPAACT were to test the efficacy of the IMPAACT intervention for persons with arthritis (N=185 persons with RA and 155 persons with knee OA) in improving arthritis-specific and generic self-reported pain and physical function outcomes, observed measures of function, and objectively measured and self-reported PA levels. Details of the stratified-randomized study design, subject recruitment, and data collection are described. The results from IMPAACT will generate empiric evidence pertaining to increasing PA levels in persons with arthritis and result in widely applicable strategies for health behavior change. PMID:25183043

  17. An Internet- and Mobile-Based Tailored Intervention to Enhance Maintenance of Physical Activity After Cardiac Rehabilitation: Short-Term Results of a Randomized Controlled Trial

    PubMed Central

    Wangberg, Silje C

    2014-01-01

    the difference was not significant (Kolmogorov-Smirnov Z=0.823, P=.38, r=.17). At 3 months after discharge, the tailored intervention group (n=7) had a significantly higher median level of overall physical activity (median 5613.0, IQR 2828.0) than the control group (n=12, median 1356.0, IQR 2937.0; Kolmogorov-Smirnov Z=1.397, P=.02, r=.33). The median adherence was 45.0 (95% CI 0.0-169.8) days for the tailored group and 111.0 (95% CI 45.1-176.9) days for the control group; however, the difference was not significant (P=.39). There were no statistically significant differences between the 2 groups in stage of change, self-efficacy, social support, perceived tailoring, anxiety, or depression. Conclusions Because of the small sample size and the high attrition rate at the follow-up visits, we cannot make conclusions regarding the efficacy of our approach, but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention. Trial Registration ClinicalTrials.gov: NCT01223170; http://clinicaltrials.gov/show/NCT01223170 (Archived by WebCite at http://www.webcitation.org/6Nch4ldcL). PMID:24618349

  18. “Pre-schoolers in the playground” an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial

    PubMed Central

    2013-01-01

    include physical activity via triaxial, accelerometry (Actigraph GT3X+), anthropometry (height, body mass, BMI, waist and upper arm circumference), health related quality of life for child (PedsQL) and parent (EQ5D), parent wellbeing (ComQol-A5), injuries and health service use. A health economic evaluation will also be undertaken. Discussion It is anticipated that results of this pilot trial will be published in spring 2015. Trial registration Current controlled trials: ISRCTN54165860 PMID:24107473

  19. 76 FR 72976 - Manufacturer of Controlled Substances Notice of Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... 22, 2011, and published in the Federal Register on June 29, 2011, 76 FR 38209, Pharmagra Labs Inc... research and clinical trials. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Pharmagra Labs, Inc. to manufacture...

  20. Dose-Response Effects of a Web-Based Physical Activity Program on Body Composition and Metabolic Health in Inactive Older Adults: Additional Analyses of a Randomized Controlled Trial

    PubMed Central

    Vroege, David P; Wijsman, Carolien A; Broekhuizen, Karen; de Craen, Anton JM; van Heemst, Diana; van der Ouderaa, Frans JG; van Mechelen, Willem; Slagboom, P Eline; Catt, Michael; Westendorp, Rudi GJ; Verhagen, Evert ALM

    2014-01-01

    . Conclusions Of the intervention group, 42.0% (50/119) reached their daily physical activity end goal, which was associated with a markedly better effect on body composition and metabolic health compared to the effect in the entire intervention group. In this population, men are more likely to be successful in increasing physical activity. Findings demonstrate that improving the effect of such physical activity interventions requires finding new ways to increase the proportion of the population reaching the targeted goal. Trial Registration Dutch Trial Registry: NTR 3045; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 (Archived by WebCite at http://www.webcitation.org/6KPw52dCc). PMID:25486673

  1. 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.

  2. Image registration with uncertainty analysis

    DOEpatents

    Simonson, Katherine M.

    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.

  3. Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study)

    PubMed Central

    Pahor, Marco; Guralnik, Jack M; McDermott, Mary M; King, Abby C; Buford, Thomas W; Strotmeyer, Elsa S; Nelson, Miriam E; Sink, Kaycee M; Demons, Jamehl L; Kashaf, Susan S; Walkup, Michael P; Miller, Michael E

    2016-01-01

    ; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction). Conclusions In this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men. Trial registration ClinicalsTrials.gov NCT01072500. PMID:26842425

  4. Inter-trial analysis of post-movement Beta activities in EEG signals using multivariate empirical mode decomposition.

    PubMed

    Chang, Hsiang-Chih; Lee, Po-Lei; Lo, Men-Tzung; Wu, Yu-Te; Wang, Kuo-Wei; Lan, Gong-Yau

    2013-07-01

    Event-related desynchronization/synchronization (ERD/ERS) is a technique to quantify subject's nonphase-locked neural activities underlying specific frequency bands, reactive to external/internal stimulus. However, conventional ERD/ERS studies usually utilize fixed frequency band determined from one or few channels to filter whole-head EEG/MEG data, which may inevitably include task-unrelated signals and result in underestimation of reactive oscillatory activities in multichannel studies. In this study, we adopted multivariate empirical mode decomposition (MEMD) to extract beta-related oscillatory activities in performing self-paced right and left index-finger lifting tasks. The MEMD extracts common modes from all channels in same-index intrinsic mode functions (IMFs) which allows the temporal-frequency features among different channels can be compared in each subband. The beta-band oscillatory activities were further bandpass filtered within trial-specific beta bands determined from sensorimotor-related channels (C3 and C4), and then rectified using amplitude modulation method to detect trial-by-trial beta rebound (BR) values in ERS time courses. The validity of the MEMD approach in BR values extraction has been demonstrated in multichannel EEG study which showed larger BR values than conventional ERS technique. The MEMD-based method enables the trial-by-trial extraction of sensorimotor oscillatory activities which might allow the exploration of subtle brain dynamics in future studies. PMID:23661320

  5. 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

  6. Activating GENeral practitioners dialogue with patients on their Agenda (MultiCare AGENDA) study protocol for a cluster randomized controlled trial

    PubMed Central

    2012-01-01

    Background This study investigates the efficacy of a complex multifaceted intervention aiming at increasing the quality of care of GPs for patients with multimorbidity. In its core, the intervention aims at enhancing the doctor-patient-dialogue and identifying the patient’s agenda and needs. Also, a medication check is embedded. Our primary hypothesis is that a more patient-centred communication will reduce the number of active pharmaceuticals taken without impairing the patients’ quality of life. Secondary hypotheses include a better knowledge of GPs about their patients’ medication, a higher patient satisfaction and a more effective and/or efficient health care utilization. Methods/design Multi-center, parallel group, cluster randomized controlled clinical trial in GP surgeries. Inclusion criteria: Patients aged 65–84 years with at least 3 chronic conditions. Intervention: GPs allocated to this group will receive a multifaceted educational intervention on performing a narrative doctor-patient dialogue reflecting treatment targets and priorities of the patient and on performing a narrative patient-centred medication review. During the one year intervention GPs will have a total of three conversations à 30 minutes with the enrolled patients. Control: Care as usual. Follow-up per patient: 14 months after baseline interview. Primary efficacy endpoints: Differences in medication intake and health related quality of life between baseline and follow-up in the intervention compared to the control group. Randomization: Computer-generated by an independent institute. It will be performed successively when patient recruitment in the respective surgery is finished. Blinding: Participants (GPs and patients) will not be blinded to their assignment but will be unaware of the study hypotheses or outcome measures. Discussion There is growing evidence that the phenomenon of polypharmacy and low quality of drug use is substantially due to mis-communication (or non

  7. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: Design of a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline. Methods/Design The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control) group or a combined pain management and training (intervention)group. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36), Physical Component Summary (PCS). Secondary outcomes will be Global Perceived Effect (-5 to +5), Neck Disability Index (0-50), Patient Specific Functioning Scale (0-10), numeric rating scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical

  8. Clinical Trial of Tailored Activity and Eating Newsletters with Older Rural Women

    PubMed Central

    Walker, Susan Noble; Pullen, Carol H.; Boeckner, Linda; Hageman, Patricia A.; Hertzog, Melody; Oberdorfer, Maureen K.; Rutledge, Matthew J.

    2009-01-01

    Background Unhealthy diet and lack of physical activity increase rural midlife and older women’s risk for chronic diseases and premature death, and they are behind urban residents in meeting Healthy People 2010 objectives. Objectives To compare a tailored intervention based on the Health Promotion Model (HPM) and a generic intervention to increase physical activity and healthy eating among rural women. Methods In a randomized by site community-based controlled clinical trial, Wellness for Women, 225 women aged 50 to 69 years were recruited in two similar rural areas. Over 12 months, women received by mail either 18 generic newsletters or 18 newsletters computer-tailored on HPM behavior-specific cognitions (benefits, barriers, self-efficacy, and interpersonal support), activity, and eating. Outcomes at 6 and 12 months included behavioral markers and biomarkers of physical activity and eating. Data were analyzed by repeated measures ANOVA and χ2 tests (α < .05). Results Both groups significantly increased stretching and strengthening exercise and fruit and vegetable servings and decreased % calories from fat, while only the tailored group increased ≥ moderate intensity activity and decreased % calories from saturated fat from baseline to 6 months. Both groups increased stretching and strengthening exercise, while only the tailored group increased ≥ moderate activity and fruit and vegetable servings and decreased % calories from fat from baseline to 12 months. Both groups had several changes in biomarkers over the study. A higher proportion of women receiving tailored newsletters met Healthy People 2010 criteria for ≥ moderate activity, fruit and vegetable servings, and % calories from fat at 12 months. Discussion Mailed computer-tailored and generic print newsletters facilitated the adoption of change in both activity and eating over 6 months. Tailored newsletters were more efficacious in facilitating change over 12 months. PMID:19289928

  9. 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 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...

  10. Articulated registration: elastic registration based on a wire-model

    NASA Astrophysics Data System (ADS)

    Martin-Fernandez, Miguel A.; Munyoz-Moreno, Emma; Martin-Fernandez, Marcos; Alberola-Lopez, Carlos

    2005-04-01

    In this paper we propose a new method of elastic registration of anatomical structures that bears an inner skeleton, such as the knee, hand or spine. Such a method has to deal with great degrees of variability, specially for the case of inter-subject registration; but even for the intra-subject case the degree of variability of images will be large since the structures we bear in mind are articulated. Rigid registration methods are clearly inappropriate for this problem, and well-known elastic methods do not usually incorporate the restriction of maintaining long skeletal structures straight. A new method is therefore needed to deal with such a situation; we call this new method "articulated registration". The inner bone skeleton is modeled with a wire model, where wires are drawn by connecting landmarks located in the main joints of the skeletal structure to be registered (long bones). The main feature of our registration method is that within the bone axis (specifically, where the wires are) an exact registration is guaranteed, while for the remaining image points an elastic registration is carried out based on a distance transform (with respect to the model wires); this causes the registration on long bones to be affine to all practical purposes, while the registration of soft tissue -- far from the bones -- is elastic. As a proof-of-concept of this method we describe the registration of hands on radiographs.

  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. Rationale, design and methods for a staggered-entry, waitlist controlled clinical trial of the impact of a community-based, family-centred, multidisciplinary program focussed on activity, food and attitude habits (Curtin University’s Activity, Food and Attitudes Program—CAFAP) among overweight adolescents

    PubMed Central

    2012-01-01

    Background Current estimates place just under one quarter of adolescents in Australia as overweight or obese. Adolescence has been identified as a critical period for the development of obesity, yet despite this recognition, there is limited systematic research into or evaluation of interventions for overweight adolescents. Reviews have concluded that there is a substantive evidence gap for effective intervention, but physical activity, lifestyle change and family involvement have been identified as promising foci for treatment. Methods This paper reports on the development of a staggered-entry, waitlist controlled clinical trial to assess the impact of a multidisciplinary intervention aiming to change the poor health trajectory of overweight adolescents and help them avoid morbid obesity in adulthood—Curtin University’s Activity, Food and Attitudes Program (CAFAP). 96 adolescents, aged 11–16 years, and parents, will attend twice weekly during an 8 week intensive multidisciplinary program with maintenance follow-up focussed on improving activity, food and attitude habits. Follow-up assessments will be conducted immediately after completing the intensive program, and at 3, 6 and 12 months post intensive program. Main outcomes will be objectively-measured physical activity, sedentary behaviour and activity behaviours; food intake (measured by 3 day diary) and food behaviours; body composition, fitness and physical function; mental and social well-being (quality of life, mood and attitudes), and family functioning. Discussion This trial will provide important information to understand whether a community based multidisciplinary intervention can have short and medium term effects on activity and food habits, attitudes, and physical and mental health status of overweight adolescents. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12611001187932. PMID:22721261

  13. Behavioural activation: a pilot trial of transdiagnostic treatment for excessive worry.

    PubMed

    Chen, Junwen; Liu, Xi; Rapee, Ronald M; Pillay, Pallavi

    2013-09-01

    Transdiagnostic interventions present pragmatic benefits in treatment dissemination and training of mental health professionals when faced with emotional disorders such as anxiety and depression. Excessive worry is a common feature across emotional disorders and represents an ideal candidate target for transdiagnostic intervention. The current pilot trial examined the efficacy of a behavioural activation treatment for worry (BAW) in a community population. 49 individuals experiencing excessive worry were randomised to waitlist or BAW receiving an 8 week group based intervention. Results demonstrated that BAW was successful in reducing excessive worry, depressive symptoms, cognitive avoidance, Intolerance of Uncertainty and improving problem solving orientation. Twice as many individuals showed clinically significant reductions in excessive worry after treatment compared to the waitlist control. Despite limitations to sample size and power, this study presents promising support for BAW as a practical transdiagnostic treatment for worry.

  14. A monitoring and feedback tool embedded in a counselling protocol to increase physical activity of patients with COPD or type 2 diabetes in primary care: study protocol of a three-arm cluster randomised controlled trial

    PubMed Central

    2014-01-01

    s acceptability for participating patients and nurses. Discussion Results of this study will give insight into the effects of the It’s LiFe! monitoring and feedback tool combined with care from a practice nurse for people with COPD or DM2 on physical activity. Trial registration ClinicalTrials.gov: NCT01867970 PMID:24885096

  15. 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

  16. Healing Touch with Guided Imagery for PTSD in returning active duty military: a randomized controlled trial.

    PubMed

    Jain, Shamini; McMahon, George F; Hasen, Patricia; Kozub, Madelyn P; Porter, Valencia; King, Rauni; Guarneri, Erminia M

    2012-09-01

    Post-traumatic stress disorder (PTSD) remains a significant problem in returning military and warrants swift and effective treatment. We conducted a randomized controlled trial to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery [HT+GI]) reduced PTSD symptoms as compared to treatment as usual (TAU) returning combat-exposed active duty military with significant PTSD symptoms. Active duty military (n = 123) were randomized to 6 sessions (within 3 weeks) of HT+GI vs. TAU. The primary outcome was PTSD symptoms; secondary outcomes were depression, quality of life, and hostility. Repeated measures analysis of covariance with intent-to-treat analyses revealed statistically and clinically significant reduction in PTSD symptoms (p < 0.0005, Cohen's d = 0.85) as well as depression (p < 0.0005, Cohen's d = 0.70) for HT+GI vs. TAU. HT+GI also showed significant improvements in mental quality of life (p = 0.002, Cohen's d = 0.58) and cynicism (p = 0.001, Cohen's d = 0.49) vs. TAU. Participation in a complementary medicine intervention resulted in a clinically significant reduction in PTSD and related symptoms in a returning, combat-exposed active duty military population. Further investigation of GT and biofield therapy approaches for mitigating PTSD in military populations is warranted.

  17. Imipenem and meropenem: Comparison of in vitro activity, pharmacokinetics, clinical trials and adverse effects

    PubMed Central

    Zhanel, George G; Simor, Andrew E; Vercaigne, Lavern; Mandell, Lionell

    1998-01-01

    OBJECTIVE: To compare and contrast imipenem and meropenem in terms of in vitro activity, pharmacokinetics, clinical efficacy and adverse effects. DATA SELECTION: MEDLINE search from 1975 to 1997 and follow-up of references. DATA EXTRACTION: Clinical trials comparing imipenem with meropenem, or either imipenem or meropenem with standard therapy in the treatment of serious infections were selected. DATA SYNTHESIS: Imipenem, the first carbapenem, was first marketed in 1987; meropenem was introduced to the market in 1996. In general, imipenem is more active against Gram-positive cocci while meropenem is more active against Gram-negative bacilli. The agents display similar pharmacokinetics. Clinical studies in patients with serious infections (intra-abdominal infection, respiratory infection, septicemia, febrile neutropenia) report similar bacteriological and clinical cure rates with imipenem and meropenem. Meropenem is approved for the treatment of bacterial meningitis, whereas imipenem is not. Adverse effects are similar. CONCLUSIONS: Current literature supports the use of imipenem at a dose of 500 mg every 6 h and meropenem at 1 g every 8 h for the treatment of severe infections. For the treatment of serious infections, imipenem (500 mg every 6 h or 2 g/day [$98/day]) is more economical than meropenem (1 g every 8 h or 3 g/day [$142/day]) based on acquisition cost. PMID:22346545

  18. “läuft.” - a school-based multi-component program to establish a physically active lifestyle in adolescence: study protocol for a cluster-randomized controlled trial

    PubMed Central

    2013-01-01

    discussions and document analyses. Discussion “läuft.” aims at fostering a physically active lifestyle in adolescence while a considerable decline of physical activity is present. Physical activity programs based in the school setting and following a multicomponent approach have been proven to be most successful. Furthermore, the use of pedometers is promising to enhance physical activity during the entire day and targets a wide range of adolescents regarding fitness and weight. Trial registration Current Controlled Trials ISRCTN49482118. PMID:24304715

  19. Anger expression and natural killer cell activity in family caregivers participating in a physical activity trial.

    PubMed

    Wilcox, S; King, A C; Vitaliano, P P; Brassington, G S

    2000-07-01

    Associations between psychological functioning and natural killer cell activity (NKA) were examined in 23 older (62.2 ± 7.5 years) family caregivers randomized to a moderate intensity four-month exercise program or to a wait-list control condition. At baseline, although NKA was related to anger-control (r = -.42; trend p < .06) and anger-out (r = .50; p < .03), it was not related to depression, anxiety, perceived stress, or caregiver burden. After controlling for baseline NKA, changes in anger-control explained 14 percent of the variance in NKA four months later. Decreases in anger-control predicted increases in NKA. Group assignment (exercise vs control) was unrelated to changes in NKA over the four-month period; however, the study was not powered to detect this effect. These results are consistent with reported relationships of anger expression with other physiological measures, and extend the importance of anger expression to immune functioning in older family caregivers.

  20. DTI Image Registration under Probabilistic Fiber Bundles Tractography Learning

    PubMed Central

    Lei, Tao; Fan, Yangyu; Zhang, Xiuwei

    2016-01-01

    Diffusion Tensor Imaging (DTI) image registration is an essential step for diffusion tensor image analysis. Most of the fiber bundle based registration algorithms use deterministic fiber tracking technique to get the white matter fiber bundles, which will be affected by the noise and volume. In order to overcome the above problem, we proposed a Diffusion Tensor Imaging image registration method under probabilistic fiber bundles tractography learning. Probabilistic tractography technique can more reasonably trace to the structure of the nerve fibers. The residual error estimation step in active sample selection learning is improved by modifying the residual error model using finite sample set. The calculated deformation field is then registered on the DTI images. The results of our proposed registration method are compared with 6 state-of-the-art DTI image registration methods under visualization and 3 quantitative evaluation standards. The experimental results show that our proposed method has a good comprehensive performance. PMID:27774455

  1. 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

  2. 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.

  3. Using Internet and Mobile Phone Technology to Deliver an Automated Physical Activity Program: Randomized Controlled Trial

    PubMed Central

    Catt, Michael; De Boni, Marco; Fairley, Bruce William; Hurst, Tina; Murray, Peter; Richardson, Alannah; Sodhi, Jaspreet Singh

    2007-01-01

    Background The Internet has potential as a medium for health behavior change programs, but no controlled studies have yet evaluated the impact of a fully automated physical activity intervention over several months with real-time objective feedback from a monitor. Objective The aim was to evaluate the impact of a physical activity program based on the Internet and mobile phone technology provided to individuals for 9 weeks. Methods A single-center, randomized, stratified controlled trial was conducted from September to December 2005 in Bedfordshire, United Kingdom, with 77 healthy adults whose mean age was 40.4 years (SD = 7.6) and mean body mass index was 26.3 (SD = 3.4). Participants were randomized to a test group that had access to an Internet and mobile phone–based physical activity program (n = 47) or to a control group (n = 30) that received no support. The test group received tailored solutions for perceived barriers, a schedule to plan weekly exercise sessions with mobile phone and email reminders, a message board to share their experiences with others, and feedback on their level of physical activity. Both groups were issued a wrist-worn accelerometer to monitor their level of physical activity; only the test group received real-time feedback via the Internet. The main outcome measures were accelerometer data and self-report of physical activity. Results At the end of the study period, the test group reported a significantly greater increase over baseline than did the control group for perceived control (P < .001) and intention/expectation to exercise (P < .001). Intent-to-treat analyses of both the accelerometer data (P = .02) and leisure time self-report data (P = .03) found a higher level of moderate physical activity in the test group. The average increase (over the control group) in accelerometer-measured moderate physical activity was 2 h 18 min per week. The test group also lost more percent body fat than the control group (test group: −2

  4. Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial

    PubMed Central

    2010-01-01

    Background Regular physical activity reduces the risk of mortality from all causes, with a powerful beneficial effect on risk of falls and hip fractures. However, physical activity levels are low in the older population and previous studies have demonstrated only modest, short-term improvements in activity levels with intervention. Design/Methods Pragmatic 3 arm parallel design cluster controlled trial of class-based exercise (FAME), home-based exercise (OEP) and usual care amongst older people (aged 65 years and over) in primary care. The primary outcome is the achievement of recommended physical activity targets 12 months after cessation of intervention. Secondary outcomes include functional assessments, predictors of exercise adherence, the incidence of falls, fear of falling, quality of life and continuation of physical activity after intervention, over a two-year follow up. An economic evaluation including participant and NHS costs will be embedded in the clinical trial. Discussion The ProAct65 trial will explore and evaluate the potential for increasing physical activity among older people recruited through general practice. The trial will be conducted in a relatively unselected population, and will address problems of selective recruitment, potentially low retention rates, variable quality of interventions and falls risk. Trial Registration Trial Registration: ISRCTN43453770 PMID:20082696

  5. Recruiting a Diverse Group of Middle School Girls Into the Trial of Activity for Adolescent Girls

    PubMed Central

    Elder, John P.; Shuler, LaVerne; Moe, Stacey G.; Grieser, Mira; Pratt, Charlotte; Cameron, Sandra; Hingle, Melanie; Pickrel, Julie L.; Saksvig, Brit I.; Schachter, Kenneth; Greer, Susan; Bothwell, Elizabeth K. Guth

    2009-01-01

    BACKGROUND School-based study recruitment efforts are both time consuming and challenging. This paper highlights the recruitment strategies employed by the national, multisite Trial of Activity for Adolescent Girls (TAAG), a study designed to measure the effectiveness of an intervention to reduce the decline of physical activity levels among middle school—aged girls. TAAG provided a unique opportunity to recruit large cohorts of randomly sampled girls within 36 diverse middle schools across the United States. METHODS Key elements of the formative planning, coordination, and design of TAAG’s recruitment efforts included flexibility, tailoring, and the use of incentives. Various barriers, including a natural disaster, political tension, and district regulations, were encountered throughout the recruitment process, but coordinated strategies and frequent communication between the 6 TAAG sites were helpful in tailoring the recruitment process at the 36 intervention and control schools. RESULTS Progressively refined recruitment strategies and specific attention to the target audience of middle school girls resulted in overall study recruitment rates of 80%, 85%, and 89%, for the baseline, posttest, and follow-up period, respectively. DISCUSSION The steady increase in recruitment rates over time is attributed to an emphasis on successful strategies and a willingness to modify less successful methods. Open and consistent communication, an increasingly coordinated recruitment strategy, interactive recruitment presentations, and participant incentives resulted in an effective recruitment campaign. PMID:18808471

  6. 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. PMID:26111942

  7. 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.

  8. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF 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...

  9. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF 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...

  10. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF 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...

  11. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF 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...

  12. 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…

  13. FIFRA-88, GLP, and QA: pesticide registration.

    PubMed

    Sterner, R T; Fagerstone, K A

    1997-01-01

    The 1988 amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA-88) has decreased the number of pesticide registrations in the United States. Subsequent implementation of the U.S. Environmental Protection Agency (EPA) Good Laboratory Practice (GLP) and quality assurance (QA) standards has increased costs of maintaining these registrations. The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) maintains approximately 30 Section 3 (federal) or Section 24c (state) vertebrate pesticide registrations for the Wildlife Services (WS) program to control wild mammals and birds that damage crops, impact endangered species, or pose human health risks. Under FIFRA-88, APHIS summarized, performed, and submitted or gained waivers for > 500 studies requested by the U.S. EPA to assess potential hazards/effects of these pesticides. A summary of FIFRA-88 milestones for registration of 3-chloro-p-toluidine hydrochloride (CPTH), the active ingredient (AI) in a "low-volume, minor-use" avicide (DRC-1339, Starlicide), is used to illustrate GLP/QA/animal welfare issues involved in this process. Trends in the development of new pesticides and veterinary drugs are compared to provide some perspectives on future career paths for QA professionals.

  14. The design of LBT's telemetry source registration

    NASA Astrophysics Data System (ADS)

    Edgin, Tony; Cushing, Norman

    2010-07-01

    In the current report, we describe the structure of the telemetry logging system of the Large Binocular Telescope (LBT) and its approach to telemeter registration. The telemetry logging system, called Telemetry, has three functions. It will provide system data to LBT Observatory (LBTO) personnel in order to facilitate engineering activities such as commissioning, failure diagnosis and system repair. In order to detect failures as soon as possible after they occur, telemetry will allow for live monitoring of the functional status of key telescope systems. Finally, in order to help personnel understand how the LBT operating characteristics evolve with time, telemetry will provide access to historical telescope system data. Given this range of functions, a key requirement of Telemetry is that it must easily adapt to new sources of data. To minimize the changes required to Telemetry, it has no pre-existing knowledge about the structure of the data it will collect. Instead, it engages in a telemeter registration process, in which the data source must describe its own structure. This registration process requires no external data files to be maintained since the description is built up by a sequence of function calls to a C++ library. So far, this strategy has proven successful, as only minor modifications have been made to accommodate the nearly 400 sources of data introduced to the system in the past year. The current report describes the design of the LBT telemetry system and its source registration process.

  15. A randomized controlled clinical trial of SPA -- the Seattle Protocol for Activity in older adults

    PubMed Central

    Teri, Linda; McCurry, Susan M.; Logsdon, Rebecca G.; Gibbons, Laura E.; Buchner, David M.; Larson, Eric B.

    2012-01-01

    OBJECTIVES Evaluate the efficacy of a physical activity program (Seattle Protocol for Activity: SPA) for low-exercising older adults, compared to educational health promotion program (HP), combination treatment (SPA+HP), and routine medical care control conditions (RMC). DESIGN Single-blinded, randomized controlled trial with 2 × 2 factorial design. SETTING: November 2001 to September 2004, in community centers in King County, Washington. PARTICIPANTS 273 community-residing, cognitively intact older adults (mean age, 79.2 y; 62% women). INTERVENTIONS SPA (in-class exercises with assistance setting weekly home exercise goals), and HP (information about age-appropriate topics relevant to enhancing health), with randomization to four conditions: SPA only (n = 69), HP only (n = 73), SPA+HP (n = 67), and RMC control (n = 64). Active treatment participants attended nine group classes over three months, followed by five booster sessions over one year. MAIN OUTCOME MEASURES Self-rated health (SF-36) and depression (GDS). Secondary ratings of physical performance, treatment adherence, and self-rated health and affective function were also collected. RESULTS At 3-months, participants in SPA exercised more and had significantly better self-reported health, strength, and general well-being (p<.05) than participants in HP or RMC. Over 18 months, SPA participants maintained health and physical function benefits, and had continued to exercise more than non-SPA participants. SPA+HP was not significantly better than SPA alone. Better adherence was associated with better outcomes. CONCLUSION Older adults participating in low levels of regular exercise can establish and maintain a home-based exercise program that yields immediate and long-term physical and affective benefits. PMID:21718259

  16. Study protocol for “Moving Bright, Eating Smart”– A phase 2 clinical trial on the acceptability and feasibility of a diet and physical activity intervention to prevent recurrence in colorectal cancer survivors

    PubMed Central

    2013-01-01

    the feasibility of targeting the two behaviours (diet and physical activity) and demonstrate the magnitude of behaviour change. The information will facilitate the design of a further larger phase III randomised controlled trial with colorectal cancer outcome as the study endpoint to determine whether this intervention model would reduce colorectal cancer recurrence and mortality. Trial registration ClinicalTrials.gov No: NCT01708824 PMID:23688320

  17. 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

  18. 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

  19. 76 FR 2111 - Notice of Receipt of Requests for Amendments to Delete Uses in Certain Pesticide Registrations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-12

    ... Registrations EPA registration no. Product name Active ingredient Delete use from label 59639-37 Sumagic Plant Growth Uniconazole Outdoor uses (Lathhouse Regulator. and Shadehouse). 59639-38 Valent...

  20. Mock Trials for Children.

    ERIC Educational Resources Information Center

    Hickey, M. Gail

    1990-01-01

    Demonstrates how role-playing in a mock trial situation allows children to view critically both sides of an issue and introduce them to trial procedure. Offers pre-trial activities, ways to teach students to see both sides of a situation, themes for mock trials, and supporting resources. (GG)

  1. 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

  2. Ascorbate-2-phosphate in red cell preservation. Clinical trials and active components.

    PubMed

    Moore, G L; Marks, D H; Carmen, R A; Ledford, M E; Nelson, E J; Fishman, R J; Leng, B S

    1988-01-01

    A red cell additive solution (AS-005) containing ascorbate-2-phosphate (AsP) to maintain 2,3-diphosphoglycerate, plus adenine, phosphate, and mannitol to retain viability and reduce hemolysis, was evaluated by human clinical trials. A crossover design was used with another additive solution (Nutricel AS-3, Cutter Laboratories) serving as the control for each donor. Each additive solution was evaluated at 35 and 42 days of storage. There was no significant difference between the red cell viability of the two storage solutions at either time period. Split-bag, AS-005 in vitro studies at two temperatures (2.5 and 5.5 degrees C), both within the range of 1 to 6 degrees C approved by the American Association of Blood Banks and the Food and Drug Administration, resulted in dramatically different in vitro parameters, including a threefold difference in 2,3-diphosphoglycerate (2,3-DPG), a fivefold difference in glucose, and significant differences in pH and adenosine triphosphate. High-pressure liquid chromatography data confirmed the preliminary report that 1 to 2 percent (wt/wt) oxalate was present in preparations of AsP. In vitro storage data confirmed that oxalate is the active component of AsP that preserves 2,3-DPG during storage.

  3. 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.

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

    PubMed

    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

    2016-02-23

    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.

  5. 22 CFR 122.3 - Registration fees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... reviewed, adjudicated or issued a response. The additional fee will be determined by multiplying $250 times...) Lapse in registration. A registrant who fails to renew a registration and, after an intervening...

  6. 22 CFR 122.3 - Registration fees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... reviewed, adjudicated or issued a response. The additional fee will be determined by multiplying $250 times...) Lapse in registration. A registrant who fails to renew a registration and, after an intervening...

  7. Computer Assisted Operations: Registration Records, Schedules

    ERIC Educational Resources Information Center

    College and University, 1977

    1977-01-01

    Proceedings of AACRAO's 63rd annual meeting cover: computer networking in small colleges; continuous registration; computer logic; computerized academic record overview; on-line registration systems; and analysis of registration and records systems. (LBH)

  8. A comparison of seven methods of within-subjects rigid-body pedobarographic image registration.

    PubMed

    Pataky, Todd C; Goulermas, John Y; Crompton, Robin H

    2008-10-20

    Image registration, the process of transforming images such that homologous structures optimally overlap, provides the pre-processing foundation for pixel-level functional image analysis. The purpose of this study was to compare the performances of seven methods of within-subjects pedobarographic image registration: (1) manual, (2) principal axes, (3) centre of pressure trajectory, (4) mean squared error, (5) probability-weighted variance, (6) mutual information, and (7) exclusive OR. We assumed that foot-contact geometry changes were negligibly small trial-to-trial and thus that a rigid-body transformation could yield optimum registration performance. Thirty image pairs were randomly selected from our laboratory database and were registered using each method. To compensate for inter-rater variability, the mean registration parameters across 10 raters were taken as representative of manual registration. Registration performance was assessed using four dissimilarity metrics (#4-7 above). One-way MANOVA found significant differences between the methods (p<0.001). Bonferroni post-hoc tests revealed that the centre of pressure method performed the poorest (p<0.001) and that the principal axes method tended to perform more poorly than remaining methods (p<0.070). Average manual registration was not different from the remaining methods (p=1.000). The results suggest that a variety of linear registration methods are appropriate for within-subjects pedobarographic images, and that manual image registration is a viable alternative to algorithmic registration when parameters are averaged across raters. The latter finding, in particular, may be useful for cases of image peculiarities resulting from outlier trials or from experimental manipulations that induce substantial changes in contact area or pressure profile geometry. PMID:18790481

  9. 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

  10. 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.

  11. 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. PMID:27617191

  12. A first step toward uncovering the truth about weight tuning in deformable image registration

    NASA Astrophysics Data System (ADS)

    Pirpinia, Kleopatra; Bosman, Peter A. N.; Sonke, Jan-Jakob; van Herk, Marcel; Alderliesten, Tanja

    2016-03-01

    Deformable image registration is currently predominantly solved by optimizing a weighted linear combination of objectives. Successfully tuning the weights associated with these objectives is not trivial, leading to trial-and-error approaches. Such an approach assumes an intuitive interplay between weights, optimization objectives, and target registration errors. However, it is not known whether this always holds for existing registration methods. To investigate the interplay between weights, optimization objectives, and registration errors, we employ multi-objective optimization. Here, objectives of interest are optimized simultaneously, causing a set of multiple optimal solutions to exist, called the optimal Pareto front. Our medical application is in breast cancer and includes the challenging prone-supine registration problem. In total, we studied the interplay in three different ways. First, we ran many random linear combinations of objectives using the well-known registration software elastix. Second, since the optimization algorithms used in registration are typically of a local-search nature, final solutions may not always form a Pareto front. We therefore employed a multi-objective evolutionary algorithm that finds weights that correspond to registration outcomes that do form a Pareto front. Third, we examined how the interplay differs if a true multi-objective (i.e., weight-free) image registration method is used. Results indicate that a trial-and-error weight-adaptation approach can be successful for the easy prone to prone breast image registration case, due to the absence of many local optima. With increasing problem difficulty the use of more advanced approaches can be of value in finding and selecting the optimal registration outcomes.

  13. 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.

  14. 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

  15. Clinical and MRI activity as determinants of sample size for pediatric multiple sclerosis trials

    PubMed Central

    Verhey, Leonard H.; Signori, Alessio; Arnold, Douglas L.; Bar-Or, Amit; Sadovnick, A. Dessa; Marrie, Ruth Ann; Banwell, Brenda

    2013-01-01

    Objective: To estimate sample sizes for pediatric multiple sclerosis (MS) trials using new T2 lesion count, annualized relapse rate (ARR), and time to first relapse (TTFR) endpoints. Methods: Poisson and negative binomial models were fit to new T2 lesion and relapse count data, and negative binomial time-to-event and exponential models were fit to TTFR data of 42 children with MS enrolled in a national prospective cohort study. Simulations were performed by resampling from the best-fitting model of new T2 lesion count, number of relapses, or TTFR, under various assumptions of the effect size, trial duration, and model parameters. Results: Assuming a 50% reduction in new T2 lesions over 6 months, 90 patients/arm are required, whereas 165 patients/arm are required for a 40% treatment effect. Sample sizes for 2-year trials using relapse-related endpoints are lower than that for 1-year trials. For 2-year trials and a conservative assumption of overdispersion (ϑ), sample sizes range from 70 patients/arm (using ARR) to 105 patients/arm (TTFR) for a 50% reduction in relapses, and 230 patients/arm (ARR) to 365 patients/arm (TTFR) for a 30% relapse reduction. Assuming a less conservative ϑ, 2-year trials using ARR require 45 patients/arm (60 patients/arm for TTFR) for a 50% reduction in relapses and 145 patients/arm (200 patients/arm for TTFR) for a 30% reduction. Conclusion: Six-month phase II trials using new T2 lesion count as an endpoint are feasible in the pediatric MS population; however, trials powered on ARR or TTFR will need to be 2 years in duration and will require multicentered collaboration. PMID:23966255

  16. [Activity and Future Perspective of Local Independent Clinical Trial Group (OGSG)].

    PubMed

    Tsujinaka, Toshimasa

    2016-04-01

    Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) was established in 2000 and has been conducting investigator initiated multi-institutional collaboration trials regarding the treatment of gastrointestinal cancer, especially using chemotherapeutic agents. Although organization of OGSG has been renovated to perform post-marketing clinical trials with high quality, OGSG is now facing severe financial crisis because of shortage of donation from pharmaceutical companies. Here, present problems and future perspectives are discussed. PMID:27220796

  17. A group-randomized controlled trial for health promotion in Girl Scouts: Healthier Troops in a SNAP (Scouting Nutrition & Activity Program)

    PubMed Central

    2010-01-01

    = .004), and more moderate-to-vigorous physical activity, (x2 = 18.4, p < .001), than girls in control troops. Conclusions Implementing a health promotion curriculum and supporting policies to provide more healthful environments in Girl Scout troop meetings appears feasible on a broader scale. Additional work is needed to bridge health promotion from such settings to other environments if lasting individual-level behavior change and obesity prevention remain targeted outcomes. Trial registration number: NCT00949637 PMID:20170502

  18. Effect of intervention aimed at increasing physical activity, reducing sedentary behaviour, and increasing fruit and vegetable consumption in children: Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial

    PubMed Central

    Kipping, Ruth R; Howe, Laura D; Jago, Russell; Campbell, Rona; Wells, Sian; Chittleborough, Catherine R; Mytton, Julie; Noble, Sian M; Peters, Tim J

    2014-01-01

    . The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account: self reported time spent in screen viewing at the weekend (–21 (–37 to –4) minutes per day), self reported servings of snacks per day (–0.22 (–0.38 to –0.05)), and servings of high energy drinks per day (–0.26 (–0.43 to –0.10)) were all reduced. Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results. Conclusion The findings suggest that the AFLY5 school based intervention is not effective at increasing levels of physical activity, decreasing sedentary behaviour, and increasing fruit and vegetable consumption in primary school children. Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level, as well as at the school environment level. These findings have relevance for researchers, policy makers, public health practitioners, and doctors who are involved in health promotion, policy making, and commissioning services. Trial registration Current Controlled Trials ISRCTN50133740. PMID:24865166

  19. 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

  20. 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.

  1. 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. PMID:27015968

  2. 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

  3. Time-Based Physical Activity Interventions for Weight Loss: A Randomized Trial

    PubMed Central

    Jakicic, John M.; Rickman, Amy D.; Lang, Wei; Davis, Kelliann K.; Gibbs, Bethany Barone; Neiberg, Rebecca; Marcus, Marsha D.

    2014-01-01

    Purpose To examine whether enhancing standard behavior weight loss interventions (SBWP) with additional strategies at the initiation of the intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18 month weight loss. Methods This was a clinical trial with participants (n=195; age= 43.2±8.6 yrs; BMI= 33.0±3.4 kg/m2) randomized to SBWP, ADOPT, or MAINTAIN. All were prescribed an energy restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT received additional phone contact (months 1–3), supervised exercise (months 1–6), and behavior campaigns (months 4–9). MAINTAIN received additional phone contact (months 4–6), supervised exercise (months 7–12), and behavior campaigns (months 13–18). Results There was a significant Group X Time interaction for weight loss (p=0.0032). SBWP lost 9.3±0.9, 7.8±1.1, and 5.9±1.2 kg at 6, 12, and 18 months, respectively. ADOPT lost 8.9±0.9, 7.6±1.2, and 5.8±1.2 kg, and MAINTAIN lost 9.7±0.9, 11.0±1.2, and 9.0±1.2 kg at 6, 12, and 18 months, respectively. The Group X Time interaction for SBWP vs. MAINTAIN (p=0.0033) and ADOPT vs. MAINTAIN (p=0.0075) was significant. There was a significant Group X Time interaction for change in fitness (p=0.0060). The Group X Time interaction for MAINTAIN vs. ADOPT (p=0.0018) was significant with a trend for MAINTAIN vs. SBWP (p=0.0525). Conclusions MAINTAIN improved 18-month weight loss compared to SBWP and ADOPT, with statistical trends that MAINTAIN resulted in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity conferred greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies to improve long-term weight loss and fitness in overweight and obese adults. PMID:25160843

  4. Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care

    PubMed Central

    2014-01-01

    Background Physical activity (PA) and nutrition are the cornerstones of diabetes management. Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes. However, it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care. Methods This study will determine whether an evidence-informed multifaceted behaviour change intervention (Movement as Medicine for Type 2 Diabetes) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting. An open pilot study conducted in two primary care practices (phase one) will assess acceptability, feasibility and fidelity. Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures. A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability, feasibility, and fidelity of the intervention (versus usual clinical care) and trial processes over a 12-month period. Consultation behaviour involving fidelity of intervention delivery, diabetes and PA related knowledge, attitudes/beliefs, intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals. We will rehearse the collection of outcome data (with the focus on data yield and quality) for a future definitive trial, through outcome assessment at baseline, one, six and twelve months. An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and

  5. Fibroblast growth factor 23 and parathyroid hormone after treatment with active vitamin D and sevelamer carbonate in patients with chronic kidney disease stage 3b, a randomized crossover trial

    PubMed Central

    2012-01-01

    Background Fibroblast growth factor 23 (FGF23) is a phosphaturic hormone that is secreted from bone and serum level increases as renal function declines. Higher levels of FGF23 are associated with increased mortality in hemodialysis-patients and in patients with chronic kidney disease (CKD) stage 2-4. The use of active vitamin D and phosphate binders as recommended in international guidelines, may affect the level of FGF23 and thereby clinical outcome. We investigated the effects of a phosphate binder and active vitamin D on the serum levels of intact FGF23 (iFGF23) and intact parathyroid hormone (iPTH) in patients with CKD stage 3b (glomerular filtration rate (GFR) 30–44 ml/min/1.73 m2). Methods Seven women and 14 men were included, mean age 65.6 ± 12.2 years. They were randomized in a 1:1 ratio to receive one of two treatment sequences. Group-1 (the alphacalcidol-sevelamer carbonate group): alphacalcidol 0.25 μg once daily for two weeks followed by sevelamer carbonate 800 mg TID with meals for two weeks after a two-week washout period. Group-2 (the sevelamer carbonate-alphacalcidol group): vice versa. Nineteen patients completed the study. The 25-hydroxyvitamin D level at baseline was 97.6 ± 25.0 nmol/l. Results There were no treatment effects on the iFGF23 and iPTH levels overall. In group-1 the iFGF23 level was higher after treatment with alphacalcidol compared with sevelamer carbonate (mean 105.8 ± 41.6 vs. 79.1 ± 36.5 pg/ml, p = 0.047 (CI: 0.4-52.9), and the iPTH level was lower (median: 26.5, range: 14.6-55.2 vs. median 36.1, range 13.4-106.9 pg/ml, p = 0.011). In group-2 the iFGF23 level increased non-significantly after treatment with sevelamer carbonate and throughout the washout period. Conclusions In this crossover trial with alphacalcidol and sevelamer carbonate in patients with CKD stage 3b, the levels of iFGF23 were not significantly different after the two treatments. However, in the group of patients

  6. 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)

  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. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... registration card or other method of registration prescribed by the Director of Selective Service by a person... the records (master computer file) of the Selective Service System. Registration is completed when... Director include completing a Selective Service Registration Card at a classified Post Office,...

  9. 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

  10. 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

  11. 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.

  12. 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…

  13. 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

  14. 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

  15. 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.

  16. HIV Prevalence and Incidence among Sexually Active Females in Two Districts of South Africa to Determine Microbicide Trial Feasibility

    PubMed Central

    Nel, Annaléne; Louw, Cheryl; Hellstrom, Elizabeth; Braunstein, Sarah L.; Treadwell, Ina; Marais, Melanie; de Villiers, Martie; Hugo, Jannie; Paschke, Inge; Andersen, Chrisna; van de Wijgert, Janneke

    2011-01-01

    Background The suitability of populations of sexually active women in Madibeng (North-West Province) and Mbekweni (Western Cape), South Africa, for a Phase III vaginal microbicide trial was evaluated. Methods Sexually active women 18–35 years not known to be HIV-positive or pregnant were tested cross-sectionally to determine HIV and pregnancy prevalence (798 in Madibeng and 800 in Mbekweni). Out of these, 299 non-pregnant, HIV-negative women were subsequently enrolled at each clinical research center in a 12-month cohort study with quarterly study visits. Results HIV prevalence was 24% in Madibeng and 22% in Mbekweni. HIV incidence rates based on seroconversions over 12 months were 6.0/100 person-years (PY) (95% CI 3.0, 9.0) in Madibeng and 4.5/100 PY (95% CI 1.8, 7.1) in Mbekweni and those estimated by cross-sectional BED testing were 7.1/100 PY (95% CI 2.8, 11.3) in Madibeng and 5.8/100 PY (95% CI 2.0, 9.6) in Mbekweni. The 12-month pregnancy incidence rates were 4.8/100 PY (95% CI 2.2, 7.5) in Madibeng and 7.0/100 PY (95% CI 3.7, 10.3) in Mbekweni; rates decreased over time in both districts. Genital symptoms were reported very frequently, with an incidence of 46.8/100 PY (95% CI 38.5, 55.2) in Madibeng and 21.5/100 PY (95% CI 15.8, 27.3) in Mbekweni. Almost all (>99%) participants said that they would be willing to participate in a microbicide trial. Conclusion These populations might be suitable for Phase III microbicide trials provided that HIV incidence rates over time remain sufficiently high to support endpoint-driven trials. PMID:21853020

  17. Local image registration a comparison for bilateral registration mammography

    NASA Astrophysics Data System (ADS)

    Celaya-Padilaa, José M.; Rodriguez-Rojas, Juan; Trevino, Victor; Tamez-Pena, José G.

    2013-11-01

    Early tumor detection is key in reducing the number of breast cancer death and screening mammography is one of the most widely available and reliable method for early detection. However, it is difficult for the radiologist to process with the same attention each case, due the large amount of images to be read. Computer aided detection (CADe) systems improve tumor detection rate; but the current efficiency of these systems is not yet adequate and the correct interpretation of CADe outputs requires expert human intervention. Computer aided diagnosis systems (CADx) are being designed to improve cancer diagnosis accuracy, but they have not been efficiently applied in breast cancer. CADx efficiency can be enhanced by considering the natural mirror symmetry between the right and left breast. The objective of this work is to evaluate co-registration algorithms for the accurate alignment of the left to right breast for CADx enhancement. A set of mammograms were artificially altered to create a ground truth set to evaluate the registration efficiency of DEMONs , and SPLINE deformable registration algorithms. The registration accuracy was evaluated using mean square errors, mutual information and correlation. The results on the 132 images proved that the SPLINE deformable registration over-perform the DEMONS on mammography images.

  18. Efficacy of a Community-Based Physical Activity Program KM2H2 for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial

    PubMed Central

    Gong, Jie; Chen, Xinguang; Li, Sijian

    2015-01-01

    Objective To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) in encouraging physical activities for the prevention of heart attack and stroke among hypertensive patients enrolled in the Community-Based Hypertension Control Program (CBHCP). Design Cluster randomized controlled trial with three waves of longitudinal assessments at baseline, 3 and 6 months post intervention. Setting Community-based and patient-centered self-care for behavioral intervention in urban settings of China. Participants A total of 450 participants diagnosed with hypertension from 12 community health centers in Wuhan, China were recruited, and were randomly assigned by center to receive either KM2H2 plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients). Intervention KM2H2 is a behavioral intervention guided by the Transtheoretical Model, the Model of Personalized Medicine and Social Capital Theory. It consists of six intervention sessions and two booster sessions engineered in a progressive manner. The purpose is to motivate and maintain physical activities for the prevention of heart attack and stroke. Outcome Measures Heart attack and stroke (clinically diagnosed, primary outcome), blood pressure (measured, secondary outcome), and physical activity (self-report, tertiary outcome) were assessed at the individual level during the baseline, 3- and 6-month post-intervention. Results Relative to the standard care, receiving KM2H2 was associated with significant reductions in the incidence of heart attack (3.60% vs. 7.03%, p < .05) and stroke (5.11% vs. 9.90%, p<0.05), and moderate reduction in blood pressure (-3.72mmHg in DBP and -2.92 mmHg in DBP) at 6-month post-intervention; and significant increases in physical activity at 3- (d = 0.53, 95% CI: 0.21, 0.85) and 6-month (d = 0.45, 95% CI: 0.04, 0.85) post-intervention, respectively. Conclusion The program KM2H2 is efficacious to reduce the

  19. Implicit reference-based group-wise image registration and its application to structural and functional MRI.

    PubMed

    Geng, Xiujuan; Christensen, Gary E; Gu, Hong; Ross, Thomas J; Yang, Yihong

    2009-10-01

    statistical detectability of brain activation compared to G2R registration.

  20. 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

  1. 21 CFR 1301.35 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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,...

  2. 21 CFR 1309.42 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...; 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...

  3. 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...

  4. 21 CFR 1301.35 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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,...

  5. 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,...

  6. 21 CFR 1309.42 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...; 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...

  7. 21 CFR 1301.35 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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,...

  8. 21 CFR 1301.35 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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,...

  9. 21 CFR 1309.42 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...; 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...

  10. 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.

  11. Mask registration and wafer overlay

    NASA Astrophysics Data System (ADS)

    Lee, Chulseung; Bang, Changjin; Kim, Myoungsoo; Kang, Hyosang; Lee, Dohwa; Jeong, Woonjae; Lim, Ok-Sung; Yoon, Seunghoon; Jung, Jaekang; Laske, Frank; Parisoli, Lidia; Roeth, Klaus-Dieter; Robinson, John C.; Jug, Sven; Izikson, Pavel; Dinu, Berta; Widmann, Amir; Choi, DongSub

    2010-03-01

    Overlay continues to be one of the key challenges for lithography in advanced semiconductor manufacturing. It becomes even more challenging due to the continued shrinking of the device node. Some low k1 techniques, such as Double Exposure and Double Patterning also add additional loss of the overlay margin due to the fact that the single layer pattern is created based on more than 1 exposure. Therefore, the overlay between 2 exposures requires very tight overlay specification. Mask registration is one of the major contributors to wafer overlay, especially field related overlay. We investigated mask registration and wafer overlay by co-analyzing the mask data and the wafer overlay data. To achieve the accurate cohesive results, we introduced the combined metrology mark which can be used for both mask registration measurement as well as for wafer overlay measurement. Coincidence of both metrology marks make it possible to subtract mask signature from wafer overlay without compromising the accuracy due to the physical distance between measurement marks, if we use 2 different marks for both metrologies. Therefore, it is possible to extract pure scanner related signatures, and to analyze the scanner related signatures in details to in order to enable root cause analysis and ultimately drive higher wafer yield. We determined the exact mask registration error in order to decompose wafer overlay into mask, scanner, process and metrology. We also studied the impact of pellicle mounting by comparison of mask registration measurement pre-pellicle mounting and post-pellicle mounting in this investigation.

  12. 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

  13. Effectiveness of a website and mobile phone based physical activity and nutrition intervention for middle-aged males: Trial protocol and baseline findings of the ManUp Study

    PubMed Central

    2012-01-01

    -group differences were observed at baseline. Discussion The ManUp Study will examine the effectiveness of an IT-based approach to improve physical activity and nutrition behaviour and literacy. Study outcomes will provide much needed information on the efficacy of this approach in middle aged males, which is important due to the large proportions of males at risk, and the potential reach of IT-based interventions. Trial registration ACTRN12611000081910 PMID:22894747

  14. 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.

  15. 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. PMID:25903450

  16. 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.

  17. Radar image registration and rectification

    NASA Technical Reports Server (NTRS)

    Naraghi, M.; Stromberg, W. D.

    1983-01-01

    Two techniques for radar image registration and rectification are presented. In the registration method, a general 2-D polynomial transform is defined to accomplish the geometric mapping from one image into the other. The degree and coefficients of the polynomial are obtained using an a priori found tiepoint data set. In the second part of the paper, a rectification procedure is developed that models the distortion present in the radar image in terms of the radar sensor's platform parameters and the topographic variations of the imaged scene. This model, the ephemeris data and the digital topographic data are then used in rectifying the radar image. The two techniques are then used in registering and rectifying two examples of radar imagery. Each method is discussed as to its benefits, shortcomings and registration accuracy.

  18. Language proficiency and nursing registration.

    PubMed

    Müller, Amanda

    2016-02-01

    This discussion paper focuses on English proficiency standards for nursing registration in Australia, how Australia has dealt with the issue of language proficiency, and the factors which have led to the establishment of the current language standards. Also, this paper will provide a comparison of the two language tests that are currently accepted in Australia (OET and IELTS), including the appropriateness of these tests and the minimum standards used. The paper will also examine the use of educational background as an indicator of language proficiency. Finally, communication-based complaints in the post-registration environment will be explored, and some discussion will be provided about why pre-registration measures might have failed to prevent such problematic situations from occurring.

  19. Language proficiency and nursing registration.

    PubMed

    Müller, Amanda

    2016-02-01

    This discussion paper focuses on English proficiency standards for nursing registration in Australia, how Australia has dealt with the issue of language proficiency, and the factors which have led to the establishment of the current language standards. Also, this paper will provide a comparison of the two language tests that are currently accepted in Australia (OET and IELTS), including the appropriateness of these tests and the minimum standards used. The paper will also examine the use of educational background as an indicator of language proficiency. Finally, communication-based complaints in the post-registration environment will be explored, and some discussion will be provided about why pre-registration measures might have failed to prevent such problematic situations from occurring. PMID:25704372

  20. 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.

  1. Effect of Atorvastatin on the Disease Activity and Severity of Rheumatoid Arthritis: Double-Blind Randomized Controlled Trial

    PubMed Central

    Mowla, Karim; Rajai, Elham; Ghorbani, Ali; Bahadoram, Mohammad; Mohammadi, Shooka

    2016-01-01

    Introduction HMG-CoA (3-hydroxy-3- methylglutary lcoenzyme A) reductase inhibitors (statins) have anti-inflammatory properties which may be particularly useful in rheumatoid arthritis to suppress disease activity and inflammatory factors. Aim The purpose of this clinical trial was to determine anti-inflammatory properties of statins in rheumatoid arthritis. Materials and Methods Eighty Iranian patients with rheumatoid arthritis, aged between 19 to 75 years were recruited to take part in this randomized, double-blind placebo-controlled trial. Subjects were randomly allocated to two groups to take atorvastatin or placebo 40 mg daily as an adjunct to current disease-modifying anti-rheumatic drugs (DMARDs) treatment. Disease Activity Score-28 (DAS28), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), swollen joint count (SJC) & tender joint count (TJC) were assessed before and after three months intervention. Results Analysis was based on intention to treat. DAS28 significantly declined in the atorvastatin group in comparison with placebo (p< 0.001). SJC, TJC, CRP and ESR also were significantly dropped in the atorvastatin group in comparison with placebo. Conclusion It can be concluded that atorvastatin can suppress RA activity and inflmmatory factors in RA patients for high to moderate grade of inflmmation. PMID:27437268

  2. Physical activity and health-related quality of life during pregnancy: a secondary analysis of a cluster-randomised trial.

    PubMed

    Kolu, Päivi; Raitanen, Jani; Luoto, Riitta

    2014-11-01

    The aim of the study was to evaluate the role of physical activity before and during pregnancy on health-related quality of life (HRQoL). Data from the cluster-randomised gestational diabetes mellitus primary prevention trial conducted in maternity clinics were utilised in a secondary analysis. The cases considered were pregnant women who reported engaging in at least 150 min of moderate-intensity leisure-time physical activity per week (active women) (N = 80), and the controls were women below these recommendations (less active) (N = 258). All participants had at least one risk factor for gestational diabetes mellitus. Their HRQoL was evaluated via the validated generic instrument 15D, with HRQoL at the end of pregnancy examined in relation to changes in physical activity during pregnancy. Logistic regression models addressed age, parity, education, and pre-pregnancy body mass index. At the end of pregnancy, the expected HRQoL was higher (tobit regression coefficient 0.022, 95 % CI 0.003-0.042) among active women than less active women. Active women also had greater mobility (OR 1.98, 95 % CI 1.04-3.78), ability to handle their usual activities (OR 2.22, 95 % CI 1.29-3.81), and vitality (OR 2.08, 95 % CI 1.22-3.54) than did less active women. Active women reported higher-quality sleep (OR 2.11, 95 % CI 1.03-4.30) throughout pregnancy as compared to less active women. Meeting of the physical activity guidelines before pregnancy was associated with better overall HRQoL and components thereof related to physical activity.

  3. Promoting physical activity using an activity monitor and a tailored web-based advice: design of a randomized controlled trial [ISRCTN93896459

    PubMed Central

    Slootmaker, Sander M; Chin A Paw, Marijke JM; Schuit, Albertine J; Seidell, Jacob C; van Mechelen, Willem

    2005-01-01

    Background Ageing is associated with a decrease in physical activity. This decrease particularly occurs during specific transitional life stages. Especially during adolescence and young adulthood a steep decrease in physical activity is observed. Inactive people are often not aware of their inactivity. Providing feedback on the actual physical activity level by an activity monitor can increase awareness and may in combination with an individually tailored physical activity advice stimulate a physically active lifestyle. Methods In a randomized controlled trial the effectiveness of providing an activity monitor in combination with a personal physical activity advice through the Internet will be examined. Outcome measures are level of physical activity, determinants of physical activity, quality of life, empowerment, aerobic fitness and body composition. Participants are relatively inactive adolescents and young adults who are measured at baseline, after 3 months intervention and 5 months after the end of the intervention. In addition, facilitating and hindering factors for implementation of the intervention will be investigated. Discussion The use of a personal activity monitor in combination with web-based assisted individually tailored health promotion offers a good opportunity to work interactively with large groups of adolescents and young adults and provide them with advice based on their actual activity level. It has great potential to motivate people to change their behaviour and to our knowledge has not been evaluated before. PMID:16356182

  4. 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.

  5. Randomized controlled trial of Syn-Ergel and an active placebo in the treatment of heartburn of pregnancy.

    PubMed

    Shaw, R W

    1978-01-01

    A randomized controlled trial was performed to study the efficacy of Syn-Ergel with an active placebo in the treatment of heartburn of pregnancy in ninety-two patients completing 7 days of therapy. Syn-Ergel was significantly better (p less than 0.001) in all groups of pre-treatment pain severity in relieving the symptoms, and had a longer duration of action, than the active placebo. Complete relief of pain was achieved in 79.5% of Syn-Ergel treatments with a further 10% of treatments resulting in marked easing of discomfort at 1 hour following administration. The corresponding figures for the 'active placebo' were 56% and 20%. The combination of an antacid and a protective mucosal coating agent would appear to be a useful approach in the treatment of heartburn of pregnacy.

  6. Tendon strain imaging using non-rigid image registration: a validation study

    NASA Astrophysics Data System (ADS)

    Almeida, Nuno M.; Slagmolen, Pieter; Barbosa, Daniel; Scheys, Lennart; Geukens, Leonie; Fukagawa, Shingo; Peers, Koen; Bellemans, Johan; Suetens, Paul; D'Hooge, Jan

    2012-03-01

    Ultrasound image has already been proved to be a useful tool for non-invasive strain quantifications in soft tissue. While clinical applications only include cardiac imaging, the development of techniques suitable for musculoskeletal system is an active area of research. On this study, a technique for speckle tracking on ultrasound images using non-rigid image registration is presented. This approach is based on a single 2D+t registration procedure, in which the temporal changes on the B-mode speckle patterns are locally assessed. This allows estimating strain from ultrasound image sequences of tissues under deformation while imposing temporal smoothness in the deformation field, originating smooth strain curves. METHODS: The tracking algorithm was systematically tested on synthetic images and gelatin phantoms, under sinusoidal deformations with amplitudes between 0.5% and 4.0%, at frequencies between 0.25Hz and 2.0Hz. Preliminary tests were also performed on Achilles tendons isolated from human cadavers. RESULTS: The strain was estimated with deviations of -0.011%+/-0.053% on the synthetic images and agreements of +/-0.28% on the phantoms. Some tests with real tendons show good tracking results. However, significant variability between the trials still exists. CONCLUSIONS: The proposed image registration methodology constitutes a robust tool for motion and deformation tracking in both simulated and real phantom data. Strain estimation in both cases reveals that the proposed method is accurate and provides good precision. Although the ex-vivo results are still preliminary, the potential of the proposed algorithm is promising. This suggests that further improvements, together with systematic testing, can lead to in-vivo and clinical applications.

  7. Review of the Registration in the Clinical Research Information Service

    PubMed Central

    2016-01-01

    Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement. PMID:26770030

  8. 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...

  9. Reconstitution of Intestinal CD4 and Th17 T Cells in Antiretroviral Therapy Suppressed HIV-Infected Subjects: Implication for Residual Immune Activation from the Results of a Clinical Trial

    PubMed Central

    d'Ettorre, Gabriella; Baroncelli, Silvia; Micci, Luca; Ceccarelli, Giancarlo; Andreotti, Mauro; Sharma, Prachi; Fanello, Gianfranco; Fiocca, Fausto; Cavallari, Eugenio Nelson; Giustini, Noemi; Mallano, Alessandra; Galluzzo, Clementina M.; Vella, Stefano; Mastroianni, Claudio M.; Silvestri, Guido; Paiardini, Mirko; Vullo, Vincenzo

    2014-01-01

    Introduction During HIV infection the severe depletion of intestinal CD4+ T-cells is associated with microbial translocation, systemic immune activation, and disease progression. This study examined intestinal and peripheral CD4+ T-cell subsets reconstitution under combined antiretroviral therapy (cART), and systemic immune activation markers. Methods This longitudinal single-arm pilot study evaluates CD4+ T cells, including Th1 and Th17, in gut and blood and soluble markers for inflammation in HIV-infected individuals before (M0) and after eight (M8) months of cART. From January 2010 to December 2011, 10 HIV-1 naïve patients were screened and 9 enrolled. Blood and gut CD4+ T-cells subsets and cellular immune activation were determined by flow-cytometry and plasma soluble CD14 by ELISA. CD4+ Th17 cells were detected in gut biopsies by immunohistochemistry. Microbial translocation was measured by limulus-amebocyte-lysate assay to detect bacterial lipopolysaccharide (LPS) and PCR Real Time to detect plasma bacterial 16S rDNA. Results Eight months of cART increased intestinal CD4+ and Th17 cells and reduced levels of T-cell activation and proliferation. The magnitude of intestinal CD4+ T-cell reconstitution correlated with the reduction of plasma LPS. Importantly, the magnitude of Th17 cells reconstitution correlated directly with blood CD4+ T-cell recovery. Conclusion Short-term antiretroviral therapy resulted in a significant increase in the levels of total and Th17 CD4+ T-cells in the gut mucosa and in decline of T-cell activation. The observation that pre-treatment levels of CD4+ and of CD8+ T-cell activation are predictors of the magnitude of Th17 cell reconstitution following cART provides further rationale for an early initiation of cART in HIV-infected individuals. Trial Registration ClinicalTrials.gov NCT02097381 PMID:25340778

  10. A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel

    PubMed Central

    Cruser, des Anges; Maurer, Douglas; Hensel, Kendi; Brown, Sarah K; White, Kathryn; Stoll, Scott T

    2012-01-01

    Objective Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. Methods This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). Results The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in ‘Pain Now’ for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less ‘Pain Now’ and ‘Pain Typical’ at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on ‘Pain at Best’ sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). Conclusion This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel. PMID:23372389

  11. 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

    ... 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... make the determinations required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide...

  12. 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.

  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. 32 CFR 1615.3 - Registration procedures.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 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 Proclamation... of Selective Service....

  15. 32 CFR 1615.3 - Registration procedures.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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 Proclamation... of Selective Service....

  16. 32 CFR 1615.3 - Registration procedures.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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 Proclamation... of Selective Service....

  17. 32 CFR 1615.3 - Registration procedures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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 Proclamation... of Selective Service....

  18. 32 CFR 1615.3 - Registration procedures.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 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 Proclamation... of Selective Service....

  19. 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

  20. 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.

  1. 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....

  2. 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....

  3. 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....

  4. 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....

  5. 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....

  6. 16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... alternative e-mail registration. 1130.8 Section 1130.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to... site registration page shall request only the consumer's name, address, telephone number,...

  7. Effect of geometrical distortion correction in MR on image registration accuracy

    NASA Astrophysics Data System (ADS)

    Maurer, Calvin R., Jr.; Aboutanos, Georges B.; Dawant, Benoit M.; Gadamsetty, Srikanth; Margolin, Richard A.; Maciunas, Robert J.; Fitzpatrick, J. Michael

    1994-05-01

    In this paper we investigate the effect of geometrical distortion correction in magnetic resonance (MR) images on the accuracy of the registration of x-ray computed tomography (CT) and MR head images for a fiducial marker (extrinsic point) method and a surface matching technique. We used CT and T2-weighted MR volume images acquired from seven patients who underwent craniotomies in a stereotactic neurosurgical clinical trial. Each patient had four external markers attached to transcutaneous post screwed into the outer table of the skull. We define registration error as the distance between corresponding marker positions after registration and transformation. The accuracy of the fiducial marker method was determined by using each combination of three markers to estimate the transformation and the remaining marker to calculate registration error. Surface-based registration was accomplished by fitting MR contours corresponding to the CSF-dura interface to CT contours derived from the inner surface of the skull. Correction of geometrical distortion in MR images significantly reduced the registration error of both point-based and surface-based registration.

  8. 12 CFR 583.18 - Registrant.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY DEFINITIONS FOR REGULATIONS AFFECTING SAVINGS AND LOAN HOLDING COMPANIES § 583.18 Registrant. The term registrant means a savings and loan holding company filing a registration statement with the Office pursuant to § 584.1 of this chapter....

  9. 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...

  10. 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...

  11. 75 FR 47729 - National Voter Registration Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    ... COMMISSION 11 CFR Part 9428 National Voter Registration Act AGENCY: Election Assistance Commission. ACTION... proposed changes to its regulations pertaining to the National Voter Registration Act of 1993 (NVRA... mail voter registration form and for submitting a biennial report to Congress on the impact of the...

  12. 32 CFR 1602.20 - Registrant.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Registrant. 1602.20 Section 1602.20 National Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM DEFINITIONS § 1602.20 Registrant. A registrant is a person registered under the Selective Service Law....

  13. 32 CFR 1602.20 - Registrant.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 6 2011-07-01 2011-07-01 false Registrant. 1602.20 Section 1602.20 National Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM DEFINITIONS § 1602.20 Registrant. A registrant is a person registered under the Selective Service Law....

  14. 32 CFR 1602.20 - Registrant.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 6 2014-07-01 2014-07-01 false Registrant. 1602.20 Section 1602.20 National Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM DEFINITIONS § 1602.20 Registrant. A registrant is a person registered under the Selective Service Law....

  15. 32 CFR 1602.20 - Registrant.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 6 2012-07-01 2012-07-01 false Registrant. 1602.20 Section 1602.20 National Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM DEFINITIONS § 1602.20 Registrant. A registrant is a person registered under the Selective Service Law....

  16. 32 CFR 1602.20 - Registrant.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 6 2013-07-01 2013-07-01 false Registrant. 1602.20 Section 1602.20 National Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM DEFINITIONS § 1602.20 Registrant. A registrant is a person registered under the Selective Service Law....

  17. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study)

    PubMed Central

    Kavanaugh, Arthur; McInnes, Iain B; Mease, Philip; Krueger, Gerald G; Gladman, Dafna; van der Heijde, Désirée; Zhou, Yiying; Lu, Jiandong; Leu, Jocelyn H; Goldstein, Neil; Beutler, Anna

    2014-01-01

    Objectives Assess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA). Methods Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-protein-based, 28-joint-count Disease Activity Score (DAS28-CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs). Results 126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8–72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate). Conclusions Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years. Trial registration number NCT00265096. PMID:24748630

  18. Registration of head volume images using implantable fiducial markers

    NASA Astrophysics Data System (ADS)

    Maurer, Calvin R., Jr.; Fitzpatrick, J. Michael; Wang, Matthew Y.; Galloway, Robert L., Jr.; Maciunas, Robert J.; Allen, George S.

    1997-04-01

    In this paper, we describe an extrinsic point-based, interactive image-guided neurosurgical system designed at Vanderbilt University as part of a collaborative effort among the departments of neurological surgery, computer science, and biomedical engineering. Multimodal image-to- image and image-to-physical registration is accomplished using implantable markers. Physical space tracking is accomplished with optical triangulation. We investigate the theoretical accuracy of point-based registration using numerical simulations, the experimental accuracy of our system using data obtained with a phantom, and the clinical accuracy of our system using data acquired in a prospective clinical trial by six neurosurgeons at four medical centers from 158 patients undergoing craniotomies to resect cerebral lesions. We can determine the position of our markers with an error of approximately 0.4 mm in x-ray computed tomography (CT) and magnetic resonance (MR) images and 0.3 mm in physical space. The theoretical registration error using four such markers distributed around the head in a configuration that is clinically practical is approximately 0.5 - 0.6 mm. The mean CT-physical registration error for the phantom experiments is 0.5 mm and for the clinical data obtained with rigid head fixation during scanning is 0.7 mm. The mean CT-MR registration error for the clinical data obtained without rigid head fixation during scanning is 1.4 mm, which is the highest mean error that we observed. These theoretical and experimental findings indicate that this system is an accurate navigational aid that can provide real-time feedback to the surgeon about anatomical structures encountered in the surgical field.

  19. 21 CFR 1301.51 - Modification in registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Modification in registration. 1301.51 Section 1301.51 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE REGISTRATION OF... Registration § 1301.51 Modification in registration. Any registrant may apply to modify his/her registration...

  20. 40 CFR 155.50 - Initiate a pesticide's registration review.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Initiate a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review...

  1. 40 CFR 155.50 - Initiate a pesticide's registration review.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Initiate a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review...

  2. 40 CFR 155.50 - Initiate a pesticide's registration review.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Initiate a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review...

  3. 40 CFR 155.50 - Initiate a pesticide's registration review.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Initiate a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review...

  4. 40 CFR 155.50 - Initiate a pesticide's registration review.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Initiate a pesticide's registration...) PESTICIDE PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review...

  5. Maintenance of Activity and Eating Change Following a Clinical Trial of Tailored Newsletters with Older Rural Women

    PubMed Central

    Walker, Susan Noble; Pullen, Carol H.; Hageman, Patricia A.; Boeckner, Linda S.; Hertzog, Melody; Oberdorfer, Maureen K.; Rutledge, Matthew J.

    2010-01-01

    Background In the Wellness for Women Project, a randomized-by-site 1-year controlled clinical trial, the efficacy of generic newsletters and tailored newsletters on Health Promotion Model behavior-specific cognitions, eating change, and activity change were compared among 225 women aged 50 to 69 years. Objectives To compare the maintenance of change in healthy eating and physical activity over 12 months following the tailored versus generic mailed newsletter intervention. Method Outcomes at 18 and 24 months included behavioral markers and biomarkers of physical activity and eating. Data were analyzed using the multivariate approach to repeated measures analysis of variance and generalized estimating equations (α < .05). Results At 18 months, the tailored group maintained levels of all eating and activity behaviors, while the generic group maintained levels of fruit and vegetable servings and moderate or greater activity, stretching exercise, lower body strength, and flexibility, but increased saturated fat intake and declined in weekly strength exercise and cardiorespiratory fitness. At 24 months, both groups maintained or returned to 12-month levels of all eating behaviors and moderate or greater activity, stretching exercise, and flexibility, but declined in cardiorespiratory fitness; the tailored group maintained levels of strength exercise and lower body strength, while the generic group decreased in both. A greater proportion of women who received tailored newsletters continued to achieve most Healthy People 2010 criteria for eating and activity. Discussion Mailed tailored print newsletters were more effective than generic newsletters in facilitating maintenance of change in eating and activity for 6 months postintervention. Both tailored and generic newsletters facilitated the maintenance of change in eating behaviors and in moderate or greater physical activity and stretching exercise, while tailored newsletters were more effective in maintaining change in

  6. Investigation of registration algorithms for the automatic tile processing system

    NASA Technical Reports Server (NTRS)

    Tamir, Dan E.

    1995-01-01

    The Robotic Tile Inspection System (RTPS), under development in NASA-KSC, is expected to automate the processes of post-flight re-water-proofing and the process of inspection of the Shuttle heat absorbing tiles. An important task of the robot vision sub-system is to register the 'real-world' coordinates with the coordinates of the robot model of the Shuttle tiles. The model coordinates relate to a tile data-base and pre-flight tile-images. In the registration process, current (post-flight) images are aligned with pre-flight images to detect the rotation and translation displacement required for the coordinate systems rectification. The research activities performed this summer included study and evaluation of the registration algorithm that is currently implemented by the RTPS, as well as, investigation of the utility of other registration algorithms. It has been found that the current algorithm is not robust enough. This algorithm has a success rate of less than 80% and is, therefore, not suitable for complying with the requirements of the RTPS. Modifications to the current algorithm has been developed and tested. These modifications can improve the performance of the registration algorithm in a significant way. However, this improvement is not sufficient to satisfy system requirements. A new algorithm for registration has been developed and tested. This algorithm presented very high degree of robustness with success rate of 96%.

  7. The effect of flexible acrylic resin on masticatory muscle activity in implant-supported mandibular overdentures: a controlled clinical trial

    PubMed Central

    Ibraheem, Eman Mostafa Ahmed; Nassani, Mohammad Zakaria

    2016-01-01

    Background It is not yet clear from the current literature to what extent masticatory muscle activity is affected by the use of flexible acrylic resin in the construction of implant-supported mandibular overdentures. Objective To compare masticatory muscle activity between patients who were provided with implant-supported mandibular overdentures constructed from flexible acrylic resin and those who were provided with implant-supported mandibular overdentures constructed from heat-cured conventional acrylic resin. Methods In this clinical trial, 12 completely edentulous patients were selected and randomly allocated into two equal treatment groups. Each patient in Group 1 received two implants to support a mandibular overdenture made of conventional acrylic resin. In Group 2, the patients received two implants to support mandibular overdentures constructed from “Versacryl” flexible acrylic resin. The maxillary edentulous arch for patients in both groups was restored by conventional complete dentures. For all patients, masseter and temporalis muscle activity was evaluated using surface electromyography (sEMG). Results The results showed a significant decrease in masticatory muscle activity among patients with implant-supported mandibular overdentures constructed from flexible acrylic resin. Conclusion The use of “Versacryl” flexible acrylic resin in the construction of implant-supported mandibular overdentures resulted in decreased masticatory muscle activity. PMID:26955445

  8. Frailty Intervention Trial (FIT)

    PubMed Central

    Fairhall, Nicola; Aggar, Christina; Kurrle, Susan E; Sherrington, Catherine; Lord, Stephen; Lockwood, Keri; Monaghan, Noeline; Cameron, Ian D

    2008-01-01

    Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity). Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a new approach to the treatment

  9. SIRRACT: An international randomized clinical trial of activity feedback during inpatient stroke rehabilitation enabled by wireless sensing

    PubMed Central

    Dorsch, Andrew K.; Thomas, Seth; Xu, Xiaoyu; Kaiser, William; Dobkin, Bruce H.

    2014-01-01

    Background Walking-related disability is the most frequent reason for inpatient stroke rehabilitation. Task-related practice is a critical component for improving patient outcomes. Objective To test the feasibility of providing quantitative feedback about daily walking performance and motivating greater skills practice via remote sensing. Methods In this phase III randomized, single blind clinical trial, patients participated in conventional therapies while wearing wireless sensors (tri-axial accelerometers) at both ankles. Activity-recognition algorithms calculated the speed, distance, and duration of walking bouts. Three times a week, therapists provided either feedback about performance on a 10-meter walk (speed-only) or walking speed feedback plus a review of walking activity recorded by the sensors (augmented). Primary outcomes at discharge included total daily walking time, derived from the sensors, and a timed 15-meter walk. Results Sixteen rehabilitation centers in 11 countries enrolled 135 participants over 15 months. Sensors recorded more than 1800 days of therapy, 37,000 individual walking bouts, and 2.5 million steps. No significant differences were found between the two feedback groups in daily walking time (15.1±13.1min vs. 16.6±14.3min, p=0.54) or 15-meter walking speed (0.93±0.47m/s vs. 0.91±0.53m/s, p=0.96). Remarkably, 30% of participants decreased their total daily walking time over their rehabilitation stay. Conclusions In this first trial of remote monitoring of inpatient stroke rehabilitation, augmented feedback beyond speed alone did not increase the time spent practicing or improve walking outcomes. Remarkably modest time was spent walking. Wireless sensing, however, allowed clinicians to audit skills practice and provided ground truth regarding changes in clinically important, mobility-related activities. PMID:25261154

  10. Long-term effect of physical activity on health-related quality of life among menopausal women: a 4-year follow-up study to a randomised controlled trial

    PubMed Central

    Mansikkamäki, Kirsi; Raitanen, Jani; Nygård, Clas-Håkan; Tomás, Eija; Rutanen, Reetta; Luoto, Riitta

    2015-01-01

    Objectives The aim of the study was to explore the long-term effects of physical activity intervention on quality of life (QoL) 4 years after an original randomised controlled trial (RCT). Design Cohort study after an RCT. Setting 95 of the 159 women from the original RCT participated in weight, height and waist circumference measurements, performed the UKK 2 km Walk Test and completed the SF-36 Health Survey questionnaire. Multilevel mixed regression models were performed in order to compare the original and current group in an RCT setting. Participants There were 159 participants in the original RCT; 2.5 years later, 102 of the women responded to a questionnaire and 4-year after the trial, there were 95 respondents. The inclusion criteria in the original RCT were: being symptomatic, experiencing daily hot flushes, age between 40 and 63 years, not using hormone therapy now or in the past 3 months, sedentary lifestyle and having last menstruated 3–36 months earlier. Main outcome measure Health-related QoL as measured with the SF-36 instrument. Results Women in the intervention group had a significantly higher probability of improved physical functioning (OR 1.41; 95% CI 1.00 to 1.99) as compared with women in the control group. In addition, women in the intervention group had higher odds of good role functioning (OR 1.21; 95% CI 0.88 to 1.67), physical health (OR 1.33; 95% CI 0.96 to 1.84) and general health (OR 1.14; 95% CI 0.81 to 1.62), relative to women in the control group, although the differences did not reach statistical significance. Conclusions Women in the intervention group showed positive long-term effects on physical and mental dimensions of QoL after 4 years. Trial registration number ISRCTN54690027. PMID:26362664

  11. 76 FR 60774 - Discontinuance of Form CO in Registration Practices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... comments must be uploaded in a single file in either the Adobe Portable Document File (PDF) format that... registration-related activities. See 72 FR 36883 (July 6, 2007). As part of this initiative, the Office... Forms TX, VA, PA, SR, and SE. See 72 FR at 36885; 37 CFR 202.3(b)(2)(ii). However, following...

  12. 77 FR 18705 - Discontinuance of Form CO in Registration Practices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... rulemaking and request for comments in regard to Form CO, CON 1, and CON 2. 76 FR 60774. The Office proposed... reengineering initiative that had an impact on a variety of registration-related activities. See 72 FR 36883... the application process and replace the traditional paper Forms TX, VA, PA, SR, and SE. See 72 FR...

  13. Exergame Apps and Physical Activity: The Results of the ZOMBIE Trial

    ERIC Educational Resources Information Center

    Cowdery, Joan; Majeske, Paul; Frank, Rebecca; Brown, Devin

    2015-01-01

    Background: Although there are thousands of health and fitness smartphone apps currently available, little research exists regarding the effects of mobile app technology on physical activity behavior. Purpose: The purpose of this study was to test whether Exergame smartphone applications increase physical activity levels. Methods: This was a…

  14. The Prescribed Amount of Physical Activity in Randomized Clinical Trials in Older Adults

    ERIC Educational Resources Information Center

    Kruger, Judy; Buchner, David M.; Prohaska, Thomas R.

    2009-01-01

    Purpose: Over the past two decades, a consensus has formed that increasing physical activity and reducing sedentary behavior in older adults are important for physical and cognitive health. Although there is strong evidence that regular physical activity can prevent or delay the onset of many chronic diseases, a major concern is ensuring that…

  15. Meursault on Trial: Multi-Skills Activities for Teaching "L'Etranger."

    ERIC Educational Resources Information Center

    Polly, Lyle R.; Buscaglia, Michael J.

    1978-01-01

    Presents a unit of activities based on a reading of Albert Camus'""L'Etranger." The activities, which can be adapted to various levels and abilities in an intermediate French class, incorporate reading, writing, listening and speaking skills. Sample materials and a bibliography are appended. (AM)

  16. Increasing organ donor registration rates by providing an immediate and complete registration opportunity: an experimental assessment of the IIFF model.

    PubMed

    Alvaro, Eusebio M; Siegel, Jason T; Jones, Sara P

    2011-12-01

    The IIFF model of organ donation holds that the simultaneous presence of four factors directly influence donor registration: (1) immediate and complete registration opportunity (ICRO), (2) information, (3) focused engagement, and (4) favorable activation. Two field experiments examined the impact of an ICRO on organ donation registration. In Study 1, participants were at town halls where they knew organ donation was to be discussed. Registration cards were distributed and then collected at the end of the session in half of the town halls. For the other half, participants were asked to mail in completed cards. In three US cities, participants given an ICRO registered at a significantly greater rate (z = 4.865, p < 0.05). Study 2, targeting Hispanics at a swap meet, differed in that the registration impact of awareness of the availability of an ICRO was investigated. Participants made aware of an ICRO registered at a significantly greater rate (z = 4.1, p = 0.000).

  17. Injury and death in clinical trials and compensation: Rule 122 DAB.

    PubMed

    Ghooi, Ravindra B

    2013-10-01

    Three amendments to the drugs and cosmetics rules were published in quick succession in 2013. These addressed the issues of compensation of injury and death in clinical trials in addition to the role and registration of Ethics Committees. Of the three, the first and the third make an impact on the clinical research activities in India. The second amendment has codified the conduct of clinical trials, putting together rules, which appeared in different sections of Schedule Y. The first amendment deals with the compensation for injuries and deaths taking place during clinical trials while the third deals with registration of Ethics Committees. Despite the long delay in the issue of compensation rules, there appears significant room for improvement. The most problematic are conditions of injury and death in which compensation has to be paid. When compared with other countries, the Indian rules seem unduly harsh on sponsors and are at significant variance with those in UK. The rules are very generous toward subjects and compensation is likely to become an alternative to insurance in terminally ill subjects. The implementation of these rules will make clinical trials in India more expensive and hurt the industry that is already struggling through other handicaps. There is an urgent need to make the the environment more industry friendly to attract more clinical work.

  18. Early biomarker activity in severe sepsis and septic shock and a contemporary review of immunotherapy trials: not a time to give up, but to give it earlier.

    PubMed

    Rivers, Emanuel P; Jaehne, Anja Kathrin; Nguyen, H Bryant; Papamatheakis, Demosthenes G; Singer, Daniel; Yang, James J; Brown, Samantha; Klausner, Howard

    2013-02-01

    Improving time to diagnosis and intervention has positively impacted outcomes in acute myocardial infarction, stroke, and trauma through elucidating the early pathogenesis of those diseases. This insight may partly explain the futility of time-insensitive immunotherapy trials for severe sepsis and septic shock. The aim of this study was to examine the early natural history of circulatory biomarker activity in sepsis, relative to previous animal and human outcome trials. We conducted a literature search using PubMed, MEDLINE, and Google Scholar to identify outcome trials targeting biomarkers with emphasis on the timing of therapy. These findings were compared with the biomarker activity observed over the first 72 h of hospital presentation in a cohort of severe sepsis and septic shock patients. Biomarker levels in animal and human research models are elevated within 30 min after exposure to an inflammatory septic stimulus. Consistent with these findings, the biomarker cascade is activated at the most proximal point of hospital presentation in our patient cohort. These circulatory biomarkers overlap; some have bimodal patterns and generally peak between 3 and 36 h while diminishing over the subsequent 72 h of observation. When this is taken into account, prior outcome immunotherapy trials have generally enrolled patients after peak circulatory biomarker concentrations. In previous immunotherapy sepsis trials, intervention was delayed after the optimal window of peak biomarker activity. As a result, future studies need to recalibrate the timing of enrollment and administration of immunotherapy agents that still may hold great promise for this deadly disease.

  19. [Study nurses in Germany--a survey of job-related activities in clinical trials as a basis for a job description and for training curricula].

    PubMed

    Fisk, Bettina; Beier, Jutta

    2007-10-01

    Until now, the conducting of clinical trials by nurses has scarcely come under scientific examination. Particularly in Germany, the field of activity has only been treated marginally in the health-care and nursing sciences. In Germany, the term 'Study Nurse' is used not only for members of the nursing profession but across disciplines; it is one of the most widely used terms. An explorative, descriptive study has been conducted employing a modified version of the Work Sampling Method. 79 Study Nurses were anonymously surveyed using a self-administered workload catalogue. 85 participated in the survey that focused on demographics, qualifications, and salary. In every workload catalogue, contact with other colleagues as well as job activities and the time spent on each activity were documented over twenty days. Study Nurses are mostly members of the nursing profession. They work mostly at university clinics and are responsible for conducting clinical trials. This applies to all trials that license medicinal products but also for trials initiated by investigators. While trial-specific documentation is their most time-intensive task, the overall role of Study Nurses encompasses a very broad range of activities. For the most part, they work alone and independently but have various contacts mainly to patients and the investigator. Future research should take into consideration the motivation for opting for the job of Study Nurse and the question of whether through their training and experience nurses are better qualified than other healthcare professionals.

  20. Maintenance of Physical Activity and Exercise Capacity After Rehabilitation in Coronary Heart Disease: A Randomized Controlled Trial

    PubMed Central

    Aliabad, Hassan Okati; Vafaeinasab, Mohammadreza; Morowatisharifabad, Mohammad Ali; Afshani, Seyed Alireza; Firoozabadi, Mahdieh Ghanbari; Forouzannia, Seyed Khalil

    2014-01-01

    Background and Objectives: Physical activity is one of the core components in cardiac rehabilitation and secondary prevention programs. This study investigated the effect of an intervention based on the health action process approach (HAPA) together with family support in the maintenance of physical activity and exercise capacity in coronary heart disease after discharge from rehabilitation. Method and Materials: In this randomized controlled trial, 96 patients with coronary heart disease were randomly assigned to control and intervention groups at the end of a rehabilitation program at Afshar Hospital, Yazd, Iran. HAPA Constructs and family support using a self-reported questionnaire and maximal oxygen uptake through a treadmill exercise test were measured prior to and 4 months after the intervention. Results: HAPA-based intervention together with family support increased scores of HAPA constructs and family support in the intervention group compared with the control group. The results showed that physical activity and exercise capacity in the intervention group was significantly higher than the control group after the intervention. Conclusion: HAPA-based intervention together with family support can be a useful tool for maintenance of physical activity and exercise capacity in coronary heart disease. PMID:25363124

  1. Effect of Novel, School-Based High-Intensity Interval Training (HIT) on Cardiometabolic Health in Adolescents: Project FFAB (Fun Fast Activity Blasts) - An Exploratory Controlled Before-And-After Trial

    PubMed Central

    2016-01-01

    development underlines the importance of our findings. We also demonstrated that school-based low-volume high-intensity interval training can be delivered as intended, thus representing a novel and scalable means of improving aspects of adolescents’ cardiometabolic health. Trial Registration ClinicalTrials.gov NCT02626767 PMID:27486660

  2. Examining Implementation of a Patient Activation and Self-management Intervention Within the Context of an Effectiveness Trial

    PubMed Central

    Lee, Catherine; Singer, Sara; Allen, Michele; Alegría, Margarita

    2014-01-01

    This qualitative study examines factors important for delivering a patient activation/self-management intervention in 13 mental health clinics within the context of an effectiveness trial to inform understanding of real-world implementation. Eighteen key personnel were interviewed about the following factors relative to the intervention and its delivery: alignment with organization values/patient needs; buy-in/support from leaders and providers; roles played by leaders and key personnel; and availability of organizational resources. Where supportive, these factors facilitated the delivery of the intervention; elsewhere, they presented as impediments. Findings from this study could help anticipate challenges to implementation that could be examined in a full-scale implementation study. PMID:24202066

  3. ACTIVATING PERIPHERAL ARTERIAL DISEASE PATIENTS TO REDUCE CHOLESTEROL: A RANDOMIZED TRIAL

    PubMed Central

    McDermott, Mary M.; Reed, George; Greenland, Philip; Mazor, Kathy M.; Pagoto, Sherry; Ockene, Judith K.; Graff, Rex; Merriam, Philip A.; Leung, Kathy; Manheim, Larry; Kibbe, Melina R.; Olendzki, Barbara; Pearce, William H.; Ockene, Ira S.

    2011-01-01

    Background Peripheral arterial disease patients are less likely than other high-risk patients to achieve ideal low density lipoprotein cholesterol (LDL-cholesterol) levels. This randomized controlled trial assessed whether a telephone counseling intervention, designed to help peripheral arterial disease patients request more intensive cholesterol lowering therapy from their physician, achieves lower LDL-cholesterol levels than two control conditions. Methods 355 peripheral arterial disease participants with baseline LDL-cholesterol ≥ 70 mg/dl were enrolled. The primary outcome was change in LDL-cholesterol level at twelve-month follow-up. There were three parallel arms: telephone counseling intervention, attention control condition, and usual care. The intervention consisted of patient-centered counseling, delivered every six weeks, encouraging participants to request increases in cholesterol-lowering therapy from their physician. The attention control condition consisted of telephone calls every six weeks providing information only. The usual care condition participated in baseline and follow-up testing. Results At 12-month follow-up, participants in the intervention improved their LDL-cholesterol level, compared to those in attention control (−18.4 mg/dl vs. −6.8 mg/dl, p= 0.010) but not compared to those in usual care (−18.4 mg/dl vs. −11.1 mg/dl, p= 0.208). Intervention participants were more likely to start a cholesterol-lowering medication or increase their cholesterol-lowering medication dose than those in the attention control (54% vs. 18%, p=0.001) and usual care (54% vs. 31%, P<0.001) conditions. Conclusion Telephone counseling that helped peripheral arterial disease patients request more intensive cholesterol-lowering therapy from their physician achieved greater LDL-cholesterol declines than an attention control arm that provided health information alone. PMID:21605733

  4. Alternative strategies for activation of the natural lactoperoxidase system in cows' milk: trials in Tanzania.

    PubMed

    Fweja, Leonard W T; Lewis, Michael J; Grandison, Alistair S

    2007-11-01

    Thiocyanate content and lactoperoxidase activity of individual cow's milk of different breeds were determined, and the effects of different lactoperoxidase system (LP-s) activation strategies were compared. Lactoperoxidase activity varied significantly between Friesian and both Ayrshire and Tanzania Short Horn Zebu (TSHZ), but differences between Ayrshire and TSHZ were not significant. There was no significant variation in SCN- content between breeds. The LP-s was activated using three strategies based on SCN-: namely; equal concentrations of SCN- and H2O2 (7:7, 10:10, 15:15 mg/l), excess SCN- concentrations (15:10, 20:10, 25:10 mg SCN-:H2O2/l), and excess H2O2 concentrations (10:15, 10:20, 10:25 mg SCN-:H2O2/l), plus a fourth strategy based on I- (15:15 mg I-:H2O2/l). The keeping quality (KQ) was assessed using pH, titratable acidity, clot on boiling and alcohol stability tests. All activation strategies enhanced the shelf life of milk (typically increasing KQ from around 10 to around 20 h), but it was clear that the effectiveness of the LP-s depends on the type and concentrations of the activators of the system. The LP-s activated using I- as an electron donor was more effective than the LP-s activated using SCN- as an electron donor, increasing the KQ by a further 6-8 h compared with SCN-.

  5. Effectiveness of a Mobile Phone App for Adults That Uses Physical Activity as a Tool to Manage Cigarette Craving After Smoking Cessation: A Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Lintunen, Taru; Kettunen, Tarja; Vanhala, Mauno; Toivonen, Hanna-Mari; Kinnunen, Kimmo; Heikkinen, Risto

    2015-01-01

    December 2015. Conclusions If the Ph.o.S app is shown to be effective, the study will provide evidence for the use of the app as a support tool for people who are trying to manage cravings during smoking cessation programs. It is anticipated that the results of the study will provide knowledge of how physical activity affects cigarette craving in real-life situations and inform the development and delivery of relapse prevention in smoking cessation treatment. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN55259451; http://www.controlled-trials.com/ISRCTN55259451 (Archived by WebCite at http://www.webcitation.org/6cKF2mzEI) PMID:26494256

  6. Applying Socioecological Model to Improve Women’s Physical Activity: A Randomized Control Trial

    PubMed Central

    Tehrani, Hadi; Majlessi, Fershteh; Shojaeizadeh, Davoud; Sadeghi, Roya; Hasani Kabootarkhani, Marzieh

    2016-01-01

    Background: A sedentary life without sufficient physical activity is recognized as a risk factor for various diseases, and a major modifiable risk factor for noncommunicable diseases. This study was conducted to investigate the effect of intervention using socioecological model in promoting women’s physical activity in the city of Kerman, Iran. Materials and Methods: In this randomized, double-blinded, controlled study, 360 women were studied at health and medical centers of Kerman. This educational intervention was based on socioecological model and conducted on 4 levels of personal, social, organizational, and political. Data collection tool included a researcher-made questionnaire based on constructs of socioecological model and the international physical activity inventory. Results: The results indicated insignificant differences between the two groups in terms of perceived social, physical, and political support and also with regard to level of physical activity before intervention. However after the intervention and according to independent t test, significant differences were observed between two groups in perceived social, physical, and political support and also level of physical activity (P < 0.001). Furthermore, mean values of the above terms increased in the intervention group. Conclusions: According to the results, interventions based on socioecological model can positively affect women’s physical activity. PMID:27247781

  7. Effectiveness of Active-Online, an Individually Tailored Physical Activity Intervention, in a Real-Life Setting: Randomized Controlled Trial

    PubMed Central

    Martin-Diener, Eva; Braun-Fahrländer, Charlotte; Bauer, Georg; Martin, Brian W

    2009-01-01

    Background Effective interventions are needed to reduce the chronic disease epidemic. The Internet has the potential to provide large populations with individual advice at relatively low cost. Objective The focus of the study was the Web-based tailored physical activity intervention Active-online. The main research questions were (1) How effective is Active-online, compared to a nontailored website, in increasing self-reported and objectively measured physical activity levels in the general population when delivered in a real-life setting? (2) Do respondents recruited for the randomized study differ from spontaneous users of Active-online, and how does effectiveness differ between these groups? (3) What is the impact of frequency and duration of use of Active-online on changes in physical activity behavior? Methods Volunteers recruited via different media channels completed a Web-based baseline survey and were randomized to Active-online (intervention group) or a nontailored website (control group). In addition, spontaneous users were recruited directly from the Active-online website. In a subgroup of participants, physical activity was measured objectively using accelerometers. Follow-up assessments took place 6 weeks (FU1), 6 months (FU2), and 13 months (FU3) after baseline. Results A total of 1531 respondents completed the baseline questionnaire (intervention group n = 681, control group n = 688, spontaneous users n = 162); 133 individuals had valid accelerometer data at baseline. Mean age of the total sample was 43.7 years, and 1146 (74.9%) were women. Mixed linear models (adjusted for sex, age, BMI category, and stage of change) showed a significant increase in self-reported mean minutes spent in moderate- and vigorous-intensity activity from baseline to FU1 (coefficient = 0.14, P = .001) and to FU3 (coefficient = 0.19, P < .001) in all participants with no significant differences between groups. A significant increase in the proportion of individuals meeting

  8. Multiple Behavior Change in Diet and Activity: A Randomized Controlled Trial Using Mobile Technology

    PubMed Central

    Spring, Bonnie; Schneider, Kristin; McFadden, H.G.; Vaughn, Jocelyn; Kozak, Andrea T.; Smith, Malaina; Moller, Arlen C.; Epstein, Leonard H.; DeMott, Andrew; Hedeker, Donald; Siddique, Juned; Lloyd-Jones, Donald M.

    2012-01-01

    Background Many patients exhibit multiple chronic disease risk behaviors. Research provides little information about advice that can maximize simultaneous health behavior changes. Methods To test which combination of diet and activity advice maximizes healthy change, we randomized 204 adults with elevated saturated fat and low fruit/vegetable intakes, high sedentary leisure time and low physical activity to one of four treatments: increase fruit/vegetable and physical activity; decrease fat and sedentary leisure; decrease fat and increase physical activity; increase fruit/vegetable and decrease sedentary leisure. Treatments provided three weeks of remote coaching supported by mobile decision support technology and financial incentives. During treatment, incentives were contingent on using the mobile device to self-monitor and attain behavioral targets; during follow-up they were contingent only on recording. The outcome was standardized, composite improvement on the four diet and activity behaviors at end of treatment and five month follow-up. Results Of those randomized, 200 (98%) completed follow-up. The increase fruit/vegetable and decrease sedentary leisure treatment improved more than the other 3 treatments (p<.001). Specifically, fruit/vegetables increased from 1.2 servings/day to 5.5; sedentary leisure decreased from 219.2 minutes/day to 89.3; saturated fat decreased from 12.0% of calories consumed to 9.5%. Differences between treatment groups were maintained through follow-up. Traditional dieting (decrease fat and increase physical activity) improved less than the other 3 treatments (p<.001). Conclusions Remote coaching supported by mobile technology and financial incentives holds promise to improve diet and activity. Targeting fruits/vegetables and sedentary leisure together maximizes overall adoption and maintenance of multiple healthy behavior changes. PMID:22636824

  9. Pedometers to enhance physical activity in COPD: a randomised controlled trial

    PubMed Central

    Horta, Paula; Espinoza, José; Aguilera, Miguel; Balmaceda, Nicolás; Castro, Ariel; Ruiz, Mauricio; Díaz, Orlando; Hopkinson, Nicholas S.

    2015-01-01

    Physical inactivity is a cardinal feature of chronic obstructive pulmonary disease (COPD), and is associated with increased morbidity and mortality. Pedometers, which have been used in healthy populations, might also increase physical activity in patients with COPD. COPD patients taking part in a 3-month individualised programme to promote an increase in their daily physical activity were randomised to either a standard programme of physical activity encouragement alone, or a pedometer-based programme. Assessments were performed by investigators blinded to treatment allocation. Change in average 1-week daily step count, 6-min walking distance (6MWD), modified Medical Research Council scale, St George’s respiratory questionnaire (SGRQ) and COPD assessment test (CAT) were compared between groups. 102 patients were recruited, of whom 97 completed the programme (pedometer group: n=50; control group: n=47); 60.8% were male with a mean±sd age of 68.7±8.5 years, and forced expiratory volume in 1 s (FEV1) 66.1±19.4% and FEV1/forced vital capacity 55.2±9.5%. Both groups had comparable characteristics at baseline. The pedometer group had significantly greater improvements in: physical activity 3080±3254 steps·day−1 versus 138.3±1950 steps·day−1 (p<0.001); SGRQ −8.8±12.2 versus −3.8±10.9 (p=0.01); CAT score −3.5±5.5 versus −0.6±6.6 (p=0.001); and 6MWD 12.4±34.6 versus −0.7±24.4 m (p=0.02) than patients receiving activity encouragement only. A simple physical activity enhancement programme using pedometers can effectively improve physical activity level and quality of life in COPD patients. PMID:25261324

  10. [Impact of the activation of intention to perform physical activity in type II diabetics: a randomized clinical trial].

    PubMed

    da Silva, Marco Antonio Vieira; Gouvêa, Giovana Renata; Claro, Anielle Fabiane Buoso; Agondi, Rúbia de Freitas; Cortellazzi, Karine Laura; Pereira, Antonio Carlos; Meneghim, Marcelo de Castro; Mialhe, Fábio Luiz

    2015-03-01

    Type II diabetes mellitus is a highly prevalent disease among the adult Brazilian population, and one that can be controlled by interventions such as physical activity, among others. The aim of this randomized controlled study was to evaluate the impact of a traditional motivational strategy, associated with the activation of intention theory, on adherence to physical activity in patients with type II, diabetes mellitus who are part of the Unified Health System (SUS). Participants were divided into a control group (CG) and an intervention group (IG). In both groups, the traditional motivational strategy was applied, but the activation of intention strategy was only applied to the IG Group. After a two-month follow-up, statistically significant differences were verified between the groups, related to the practice of walking (p = 0.0050), number of days per week (p = 0.0076), minutes per day (p = 0.0050) and minutes walking per week (p = 0.0015). At the end of the intervention, statistically significant differences in abdominal circumference (p = 0.0048) between the groups were observed. The conclusion drawn is that the activation of intention strategy had greater impact on adherence to physical activity and reduction in abdominal circumference in type II diabetics, than traditional motivational strategy.

  11. Cost-effectiveness of physical activity among women with menopause symptoms: findings from a randomised controlled trial.

    PubMed

    Kolu, Päivi; Raitanen, Jani; Nygård, Clas-Håkan; Tomás, Eija; Luoto, Riitta

    2015-01-01

    Menopause is a period that may predispose one to a decrease in muscle strength, cardiorespiratory fitness, and quality of life. A study was carried out to evaluate the cost-effectiveness of physical activity among women displaying symptoms of menopause. The cost-effectiveness analysis was based on data from a six-month randomised controlled trial (n = 151). The women in the intervention group engaged in an unsupervised session of at least 50 minutes of physical activity four times a week. The control group continued their physical activity as before. An incremental cost-effectiveness ratio (ICER) was calculated in terms of maximal oxygen consumption, lean muscle mass, and quality-adjusted life years (QALYs) gained. A bootstrap technique was utilised to estimate uncertainty around the point estimate for ICER associated with the intervention. The mean total cost in the intervention group was €1,307 (SEM: €311) and in the control group was €1,253 (SEM: €279, p = 0.10) per person. The mean intervention cost was €208 per person. After six months of the behaviour-change intervention, the ICER was €63 for a 1 ml/kg/min improvement in cardiorespiratory fitness, the additional cost per one-gram increase in lean muscle mass was €126, and the cost per QALY gained was €46. According to the findings, physical activity among menopausal women was cost-effective for cardiorespiratory fitness, for lean muscle mass, and for QALYs gained, since the intervention was more effective than the actions within the control group and the additional effects of physical activity were gained at a very low price. From the societal perspective, the intervention used may promote ability to work and thereby save on further costs associated with early retirement or disability pension if the physical-activity level remains at least the same as during the intervention. PMID:26258804

  12. Cortical activities of single-trial P300 amplitudes modulated by memory load using simultaneous EEG-fMRI

    NASA Astrophysics Data System (ADS)

    Zhang, Qiushi; Zhao, Xiaojie; Zhu, Chaozhe; Yang, Xueqian; Yao, Li

    2015-03-01

    The functional magnetic resonance imaging (fMRI) researches on working memory have found that activation of cortical areas appeared dependent on memory load, and event-related potentials (ERP) studies have demonstrated that amplitudes of P300 decreased significantly when working memory load increased. However, the cortical activities related with P300 amplitudes under different memory loads remains unclear. Joint fMRI and EEG analysis which fusions the time and spatial information in simultaneous EEG-fMRI recording can reveal the regional activation at each ERP time point. In this paper, we first used wavelet transform to obtain the single-trial amplitudes of P300 caused by a digital N-back task in the simultaneous EEG-fMRI recording as the ERP feature sequences. Then the feature sequences in 1-back condition and 3-back condition were introduced into general linear model (GLM) separately as parametric modulations to compare the cortical activation under different memory loads. The results showed that the average amplitudes of P300 in 3-back significantly decreased than that in 1-back, and the activities induced by ERP feature sequences in 3-back also significantly decreased than that in the 1-back, including the insular, anterior cingulate cortex, right inferior frontal gyrus, and medial frontal gyrus, which were relevant to the storage, monitoring, and manipulation of information in working memory task. Moreover, the difference in the activation caused by ERP feature showed a positive correlation with the difference in behavioral performance. These findings demonstrated the locations of P300 amplitudes differences modulated by the memory load and its relationship with the behavioral performance.

  13. Trial Watch

    PubMed Central

    Galluzzi, Lorenzo; Vacchelli, Erika; Fridman, Wolf Hervé; Galon, Jerome; Sautès-Fridman, Catherine; Tartour, Eric; Zucman-Rossi, Jessica; Zitvogel, Laurence; Kroemer, Guido

    2012-01-01

    Since the advent of hybridoma technology, dating back to 1975, monoclonal antibodies have become an irreplaceable diagnostic and therapeutic tool for a wide array of human diseases. During the last 15 years, several monoclonal antibodies (mAbs) have been approved by FDA for cancer therapy. These mAbs are designed to (1) activate the immune system against tumor cells, (2) inhibit cancer cell-intrinsic signaling pathways, (3) bring toxins in the close proximity of cancer cells, or (4) interfere with the tumor-stroma interaction. More recently, major efforts have been made for the development of immunostimulatory mAbs that either enhance cancer-directed immune responses or limit tumor- (or therapy-) driven immunosuppression. Some of these antibodies, which are thought to facilitate tumor eradication by initiating or sustaining a tumor-specific immune response, have already entered clinical trials. In this Trial Watch, we will review and discuss the clinical progress of the most important mAbs that are have entered clinical trials after January 2008. PMID:22720209

  14. Trial Watch

    PubMed Central

    Aranda, Fernando; Vacchelli, Erika; Obrist, Florine; Eggermont, Alexander; Galon, Jérôme; Hervé Fridman, Wolf; Cremer, Isabelle; Tartour, Eric; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2014-01-01

    The expression “adoptive cell transfer” (ACT) is commonly employed to indicate an immunotherapeutic regimen involving the isolation of autologous blood-borne or tumor-infiltrating lymphocytes, their selection/expansion/activation ex vivo, and their reinfusion into the patient, most often in the context of lymphodepleting pre-conditioning and in combination with immunostimulatory treatments. Optionally, the cellular material for ACT is genetically manipulated before expansion to (1) target specific tumor-associated antigens; (2) endogenously express immunostimulatory molecules; and/or (3) persist for long periods upon reinfusion. Consistent efforts have been dedicated at the amelioration of this immunotherapeutic regimen throughout the past decade, resulting in the establishment of ever more efficient and safer ACT protocols. Accordingly, the number of clinical trials testing ACT in oncological indications does not cease to increase. In this Trial Watch, we summarize recent developments in this exciting area of research, covering both high-impact studies that have been published during the last 12 months and clinical trials that have been launched in the same period to evaluate the safety and therapeutic potential of ACT in cancer patients. PMID:25050207

  15. A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital.

    PubMed

    Hopko, Derek R; Lejuez, C W; LePage, James P; Hopko, Sandra D; McNeil, Daniel W

    2003-09-01

    The brief behavioral activation treatment for depression (BATD) is a relatively uncomplicated, time-efficient, and cost-effective method for treating depression. Because of these features, BATD may represent a practical intervention within managed care-driven, inpatient psychiatric hospitals. Based on basic behavioral theory and empirical evidence supporting activation strategies, we designed a treatment to increase systematically exposure to positive activities and thereby help to alleviate depressive affect. This study represents a pilot study that extends research on this treatment into the context of an inpatient psychiatric unit. Results demonstrate effectiveness and superiority of BATD as compared with the standard supportive treatment provided within the hospital. A large effect size was demonstrated, despite a limited sample size. The authors discuss the limitations of the study and future directions.

  16. Diffusion tensor image registration using polynomial expansion

    NASA Astrophysics Data System (ADS)

    Wang, Yuanjun; Chen, Zengai; Nie, Shengdong; Westin, Carl-Fredrik

    2013-09-01

    In this paper, we present a deformable registration framework for the diffusion tensor image (DTI) using polynomial expansion. The use of polynomial expansion in image registration has previously been shown to be beneficial due to fast convergence and high accuracy. However, earlier work was developed only for 3D scalar medical image registration. In this work, it is shown how polynomial expansion can be applied to DTI registration. A new measurement is proposed for DTI registration evaluation, which seems to be robust and sensitive in evaluating the result of DTI registration. We present the algorithms for DTI registration using polynomial expansion by the fractional anisotropy image, and an explicit tensor reorientation strategy is inherent to the registration process. Analytic transforms with high accuracy are derived from polynomial expansion and used for transforming the tensor's orientation. Three measurements for DTI registration evaluation are presented and compared in experimental results. The experiments for algorithm validation are designed from simple affine deformation to nonlinear deformation cases, and the algorithms using polynomial expansion give a good performance in both cases. Inter-subject DTI registration results are presented showing the utility of the proposed method.

  17. Combining registration and active shape models for the automatic segmentation of the lymph node regions in head and neck CT images

    SciTech Connect

    Chen Antong; Deeley, Matthew A.; Niermann, Kenneth J.; Moretti, Luigi; Dawant, Benoit M.

    2010-12-15

    Purpose: Intensity-modulated radiation therapy (IMRT) is the state of the art technique for head and neck cancer treatment. It requires precise delineation of the target to be treated and structures to be spared, which is currently done manually. The process is a time-consuming task of which the delineation of lymph node regions is often the longest step. Atlas-based delineation has been proposed as an alternative, but, in the authors' experience, this approach is not accurate enough for routine clinical use. Here, the authors improve atlas-based segmentation results obtained for level II-IV lymph node regions using an active shape model (ASM) approach. Methods: An average image volume was first created from a set of head and neck patient images with minimally enlarged nodes. The average image volume was then registered using affine, global, and local nonrigid transformations to the other volumes to establish a correspondence between surface points in the atlas and surface points in each of the other volumes. Once the correspondence was established, the ASMs were created for each node level. The models were then used to first constrain the results obtained with an atlas-based approach and then to iteratively refine the solution. Results: The method was evaluated through a leave-one-out experiment. The ASM- and atlas-based segmentations were compared to manual delineations via the Dice similarity coefficient (DSC) for volume overlap and the Euclidean distance between manual and automatic 3D surfaces. The mean DSC value obtained with the ASM-based approach is 10.7% higher than with the atlas-based approach; the mean and median surface errors were decreased by 13.6% and 12.0%, respectively. Conclusions: The ASM approach is effective in reducing segmentation errors in areas of low CT contrast where purely atlas-based methods are challenged. Statistical analysis shows that the improvements brought by this approach are significant.

  18. The functional organization of trial-related activity in lexical processing after early left hemispheric brain lesions: An event-related fMRI study

    PubMed Central

    Fair, Damien A.; Choi, Alexander H.; Dosenbach, Yannic B.L.; Coalson, Rebecca S.; Miezin, Francis M.; Petersen, Steven E.; Schlaggar, Bradley L.

    2009-01-01

    Children with congenital left hemisphere damage due to perinatal stroke are capable of acquiring relatively normal language functions despite experiencing a cortical insult that in adults often leads to devastating lifetime disabilities. Although this observed phenomenon accepted, its neurobiological mechanisms are not well characterized. In this paper we examined the functional neuroanatomy of lexical processing in 13 children/adolescents with perinatal left hemispheric damage. In contrast to many previous perinatal infarct fMRI studies, we use an event-related design, which allowed us to isolate trial related activity and examine correct and error trials separately. Using both group and single subject analysis techniques we attempt to address several methodological factors that may contribute to some discrepancies in the perinatal lesion literature. These methodological factors include making direct statistical comparisons, using common stereotactic space, using both single-subject and group analyses, and accounting for performance differences. Our group analysis, investigating correct trial related activity (separately from error trials), showed very few statistical differences in the non-involved right hemisphere between patients and performance matched controls. The single subject analysis revealed atypical regional activation patterns in several patients; however, the location of these regions identified in individual patients often varied across subjects. These results are consistent with the idea that alternative functional organization of trial-related activity after left hemisphere lesions is in large part unique to the individual. In addition, reported differences between results obtained with event-related designs and blocked designs may suggest diverging organizing principles for sustained and trial-related activity after early childhood brain injuries. PMID:19819000

  19. Consistency-based rectification of nonrigid registrations

    PubMed Central

    Gass, Tobias; Székely, Gábor; Goksel, Orcun

    2015-01-01

    Abstract. We present a technique to rectify nonrigid registrations by improving their group-wise consistency, which is a widely used unsupervised measure to assess pair-wise registration quality. While pair-wise registration methods cannot guarantee any group-wise consistency, group-wise approaches typically enforce perfect consistency by registering all images to a common reference. However, errors in individual registrations to the reference then propagate, distorting the mean and accumulating in the pair-wise registrations inferred via the reference. Furthermore, the assumption that perfect correspondences exist is not always true, e.g., for interpatient registration. The proposed consistency-based registration rectification (CBRR) method addresses these issues by minimizing the group-wise inconsistency of all pair-wise registrations using a regularized least-squares algorithm. The regularization controls the adherence to the original registration, which is additionally weighted by the local postregistration similarity. This allows CBRR to adaptively improve consistency while locally preserving accurate pair-wise registrations. We show that the resulting registrations are not only more consistent, but also have lower average transformation error when compared to known transformations in simulated data. On clinical data, we show improvements of up to 50% target registration error in breathing motion estimation from four-dimensional MRI and improvements in atlas-based segmentation quality of up to 65% in terms of mean surface distance in three-dimensional (3-D) CT. Such improvement was observed consistently using different registration algorithms, dimensionality (two-dimensional/3-D), and modalities (MRI/CT). PMID:26158083

  20. A Double-Blind Atropine Trial for Active Learning of Autonomic Function

    ERIC Educational Resources Information Center

    Fry, Jeffrey R.; Burr, Steven A.

    2011-01-01

    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…

  1. A short-term physical activity randomized trial in the Lower Mississippi Delta

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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. A sample of 43 overweight adults 35 to 64 years of age participated in...

  2. Randomized Controlled Trial of Behavioral Activation Smoking Cessation Treatment for Smokers with Elevated Depressive Symptoms

    ERIC Educational Resources Information Center

    MacPherson, Laura; Tull, Matthew T.; Matusiewicz, Alexis K.; Rodman, Samantha; Strong, David R.; Kahler, Christopher W.; Hopko, Derek R.; Zvolensky, Michael J.; Brown, Richard A.; Lejuez, C. W.

    2010-01-01

    Objective: Depressive symptoms are associated with poor smoking cessation outcomes, and there remains continued interest in behavioral interventions that simultaneously target smoking and depressive symptomatology. In this pilot study, we examined whether a behavioral activation treatment for smoking (BATS) can enhance cessation outcomes. Method:…

  3. Video game play, child diet, and physical activity behavior change: A randomized clinical trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Video games designed to promote behavior change are a promising venue to enable children to learn healthier behaviors. The purpose is to evaluate the outcome from playing "Escape from Diab" (Diab) and "Nanoswarm: Invasion from Inner Space" (Nano) video games on children's diet, physical activity, an...

  4. Social support and physical activity change in Latinas: Results from the Seamos Saludables trial

    PubMed Central

    Marquez, Becky; Dunsiger, Shira I.; Pekmezi, Dori; Larsen, Britta A.; Marcus, Bess H.

    2016-01-01

    Objective Family responsibilities and poor social support are barriers to physical activity among Latinas. This study evaluated the effects of a home- and print-based intervention on social support, moderating effects of familial ties on support and moderate-to-vigorous physical activity (MVPA), and mediating effects of support on MVPA. Methods Participants were randomized to receive through the mail either individually tailored physical activity intervention or general wellness print materials. Familial ties and social support were assessed by marital and child status and the social support for physical activity measure, respectively. MVPA was measured using the 7-day Physical Activity Recall Interview and accelerometer. Assessments were conducted at baseline, 6 months post-treatment, and 12 months follow-up. Results Participants (n=266; 40.6 ± 9.9 years old) were mostly immigrant and Spanish-speaking Latinas. The intervention group achieved greater increases in family and friend support compared to the wellness control group from baseline to post-treatment and follow-up (p<0.05). Intervention changes in support did not depend on marital or child status. The intervention also increased minutes per week of MVPA more than the wellness control (p<0.05) and the effect did not depend on marital or child status. There were significant indirect effects of treatment, indicating the intervention achieved greater increases in MVPA by increasing family (ab=5.21, SE=2.94, 95% CI=0.91–14.11) and friend (ab=6.83, SE=5.15, 95% CI=0.16–20.56) support. Conclusions The intervention improved and sustained support from family and friends and MVPA irrespective of familial ties. Social support mediated increases in MVPA. PMID:26863464

  5. Playing Active Video Games may not develop movement skills: An intervention trial

    PubMed Central

    Barnett, Lisa M.; Ridgers, Nicola D.; Reynolds, John; Hanna, Lisa; Salmon, Jo

    2015-01-01

    Background: To investigate the impact of playing sports Active Video Games on children's actual and perceived object control skills. Methods: Intervention children played Active Video Games for 6 weeks (1 h/week) in 2012. The Test of Gross Motor Development-2 assessed object control skill. The Pictorial Scale of Perceived Movement Skill Competence assessed perceived object control skill. Repeated measurements of object control and perceived object control were analysed for the whole sample, using linear mixed models, which included fixed effects for group (intervention or control) and time (pre and post) and their interaction. The first model adjusted for sex only and the second model also adjusted for age, and prior ball sports experience (yes/no). Seven mixed-gender focus discussions were conducted with intervention children after programme completion. Results: Ninety-five Australian children (55% girls; 43% intervention group) aged 4 to 8 years (M 6.2, SD 0.95) participated. Object control skill improved over time (p = 0.006) but there was no significant difference (p = 0.913) between groups in improvement (predicted means: control 31.80 to 33.53, SED = 0.748; intervention 30.33 to 31.83, SED = 0.835). A similar result held for the second model. Similarly the intervention did not change perceived object control in Model 1 (predicted means: control: 19.08 to 18.68, SED = 0.362; intervention 18.67 to 18.88, SED = 0.406) or Model 2. Children found the intervention enjoyable, but most did not perceive direct equivalence between Active Video Games and ‘real life’ activities. Conclusions: Whilst Active Video Game play may help introduce children to sport, this amount of time playing is unlikely to build skill. PMID:26844136

  6. Trial Watch

    PubMed Central

    Aranda, Fernando; Vacchelli, Erika; Eggermont, Alexander; Galon, Jerome; Fridman, Wolf Hervé; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2014-01-01

    Immunostimulatory monoclonal antibodies (mAbs) exert antineoplastic effects by eliciting a novel or reinstating a pre-existing antitumor immune response. Most often, immunostimulatory mAbs activate T lymphocytes or natural killer (NK) cells by inhibiting immunosuppressive receptors, such as cytotoxic T lymphocyte-associated protein 4 (CTLA4) or programmed cell death 1 (PDCD1, best known as PD-1), or by engaging co-stimulatory receptors, like CD40, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4, best known as OX40) or TNFRSF18 (best known as GITR). The CTLA4-targeting mAb ipilimumab has been approved by the US Food and Drug Administration for use in patients with unresectable or metastatic melanoma in 2011. The therapeutic profile of ipilimumab other CTLA4-blocking mAbs, such as tremelimumab, is currently being assessed in subjects affected by a large panel of solid neoplasms. In the last few years, promising clinical results have also been obtained with nivolumab, a PD-1-targeting mAb formerly known as BMS-936558. Accordingly, the safety and efficacy of nivolumab and other PD-1-blocking molecules are being actively investigated. Finally, various clinical trials are underway to test the therapeutic potential of OX40- and GITR-activating mAbs. Here, we summarize recent findings on the therapeutic profile of immunostimulatory mAbs and discuss clinical trials that have been launched in the last 14 months to assess the therapeutic profile of these immunotherapeutic agents. PMID:24701370

  7. An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: a double-blind, placebo-controlled trial.

    PubMed

    Viscusi, Eugene R; Reynolds, Lowell; Tait, Stacy; Melson, Timothy; Atkinson, Linda E

    2006-01-01

    An iontophoretic fentanyl HCl patient-activated transdermal system (fentanyl HCl PATS) is under development for the treatment of acute postoperative pain. The fentanyl HCl PATS is a needle-free, credit card-sized, preprogrammed system that is applied to the patient's upper outer arm or chest. The fentanyl HCl PATS was demonstrated to be superior to placebo in a previous trial; however, the randomization scheme used and the lack of control of entry pain level may have contributed to the lack of robust findings. We compared the fentanyl HCl PATS with placebo for acute postoperative pain management in a larger trial that addressed the limitations of the previous study. Adult patients admitted to the postanesthesia care unit after major surgery were titrated to comfort with opioids and randomized 1:1 to receive the fentanyl HCl PATS 40 microg or placebo for 24 hours. Supplemental IV fentanyl was available to patients upon request in both treatment groups for the first 3 hours after enrollment. The primary efficacy end-point was the percentage of patients who discontinued participation in the study because of inadequate analgesia. Pain intensity scores, patient global assessments (PGA), and investigator global assessments (IGA) were collected. Four-hundred-eighty-four patients (PATS, n = 244; placebo, n = 240) were enrolled. Fewer patients receiving the fentanyl HCl PATS discontinued because of inadequate analgesia compared with placebo (28.7% versus 60.0%; P < 0.0001). Mean last pain intensity scores were 3.5 and 5.4 for the fentanyl HCl PATS and placebo groups, respectively. Patients (73.4%, PGA) and investigators (72.1%, IGA) considered the fentanyl HCl PATS a good or excellent method of pain control. Treatment-related adverse events were similar between groups. This study demonstrated the superiority of the iontophoretic fentanyl HCl PATS over placebo for acute postoperative pain management. PMID:16368828

  8. Antidiabetic activity of Aloe vera L. juice. I. Clinical trial in new cases of diabetes mellitus.

    PubMed

    Yongchaiyudha, S; Rungpitarangsi, V; Bunyapraphatsara, N; Chokechaijaroenporn, O

    1996-11-01

    Aloe vera gel has been claimed to have antidiabetic activity but not all published results are consistent. We investigated the effect of oral administration of one tablespoonful of Aloe vera juice, twice a day for at least 2 weeks in patients with diabetes. Blood sugar and triglyceride levels in the treated group fell; cholesterol levels were not affected. The results suggest the potential of aloe vera juice for use as an antidiabetic agent.

  9. Web-based Intervention to Promote Physical Activity by Sedentary Older Adults: Randomized Controlled Trial

    PubMed Central

    Gelatt, Vicky A; Seeley, John R; Macfarlane, Pamela; Gau, Jeff M

    2013-01-01

    Background Physical activity (PA) for older adults has well-documented physical and cognitive benefits, but most seniors do not meet recommended guidelines for PA, and interventions are lacking. Objectives This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older adults over 55 years of age adopt and maintain an exercise regimen. Methods A total of 368 sedentary men and women (M=60.3; SD 4.9) were recruited, screened, and assessed online. They were randomized into treatment and control groups and assessed at pretest, at 12 weeks, and at 6 months. After treatment group participants rated their fitness level, activity goals, and barriers to exercise, the Internet intervention program helped them select exercise activities in the areas of endurance, flexibility, strengthening, and balance enhancement. They returned to the program weekly for automated video and text support and education, with the option to change or increase their exercise plan. The program also included ongoing problem solving to overcome user-identified barriers to exercise. Results The multivariate model indicated significant treatment effects at posttest (P=.001; large effect size) and at 6 months (P=.001; medium effect size). At posttest, intervention participation showed significant improvement on 13 of 14 outcome measures compared to the control participants. At 6 months, treatment participants maintained large gains compared to the control participants on all 14 outcome measures. Conclusions These results suggest that an online PA program has the potential to positively impact the physical activity of sedentary older adult participants. More research is needed to replicate the study results, which were based on self-report measures. Research is also needed on intervention effects with older populations. PMID:23470322

  10. An 8-Month Randomized Controlled Exercise Trial Alters Brain Activation During Cognitive Tasks in Overweight Children

    PubMed Central

    Krafft, Cynthia E.; Schwarz, Nicolette F.; Chi, Lingxi; Weinberger, Abby L.; Schaeffer, David J.; Pierce, Jordan E.; Rodrigue, Amanda L.; Yanasak, Nathan E.; Miller, Patricia H.; Tomporowski, Phillip D.; Davis, Catherine L.; McDowell, Jennifer E.

    2014-01-01

    Objective Children who are less fit reportedly have lower performance on tests of cognitive control and differences in brain function. This study examined the effect of an exercise intervention on brain function during two cognitive control tasks in overweight children. Design and Methods Participants included 43 unfit, overweight (BMI ≥ 85th percentile) children 8- to 11-years old (91% Black), who were randomly divided into either an aerobic exercise (n = 24) or attention control group (n = 19). Each group was offered a separate instructor-led after-school program every school day for 8 months. Before and after the program, all children performed two cognitive control tasks during functional magnetic resonance imaging (fMRI): antisaccade and flanker. Results Compared to the control group, the exercise group decreased activation in several regions supporting antisaccade performance, including precentral gyrus and posterior parietal cortex, and increased activation in several regions supporting flanker performance, including anterior cingulate and superior frontal gyrus. Conclusions Exercise may differentially impact these two task conditions, or the paradigms in which cognitive control tasks were presented may be sensitive to distinct types of brain activation that show different effects of exercise. In sum, exercise appears to alter efficiency or flexible modulation of neural circuitry supporting cognitive control in overweight children. PMID:23788510

  11. Activity Pacing Self-Management in Chronic Fatigue Syndrome: A Randomized Controlled Trial

    PubMed Central

    van Eupen, Inge; Meirte, Jill; Van Cauwenbergh, Deborah; Moorkens, Greta; Meeus, Mira; Nijs, Jo

    2015-01-01

    OBJECTIVE. The objective of this study was to evaluate the effectiveness of an activity pacing self-management (APSM) intervention in improving performance of daily life activities in women with chronic fatigue syndrome (CFS). METHOD. A total of 33 women with CFS (age 41.1 ± 11.2 yr) were randomly allocated to APSM (experimental group; n = 16) or relaxation (control group; n = 17). Main outcome measures included the Canadian Occupational Performance Measure (COPM; primary) and Checklist Individual Strength (CIS). RESULTS. COPM scores changed significantly over time in both groups (p = .03). The change in Satisfaction scores showed a significant difference in favor only of APSM (effect size = 0.74 [0.11, 1.4]). CIS scores decreased significantly in the experimental group only (p < .01). CONCLUSION. APSM was found to be feasible and effective in optimizing participation in desired daily life activities in women with CFS. Replication in a larger sample with long-term follow-up is required. PMID:26356665

  12. The Use of Text Messaging to Promote Physical Activity in Working Women: A Randomized Controlled Trial

    PubMed Central

    Gell, Nancy M.; Wadsworth, Danielle D.

    2014-01-01

    Background The study evaluated the effects of a text message intervention on physical activity in adult working women. Methods Eighty-seven participants were randomized to an intervention (n=41) or control group (n=46). Pedometer step counts and measures of self-efficacy were collected at baseline, 12 and 24 weeks. Intervention participants received approximately three text messages per week that were motivational, informational, and specific to performing physical activity. Results ANCOVA results showed a significant difference between groups for mean steps/day at 12 weeks (6540.0 vs. 5685.0, p=.01) and no significant difference at 24 weeks (6867.7 vs. 6189.0, p= .06). There was no change in mean step counts during or after the intervention compared to baseline. There was a significant difference between groups for mean self-efficacy scores at 12 weeks (68.5, vs. 60.3, p=.02) and at 24 weeks (67.3 vs. 59.0, p=.03). Conclusions Intervention participants had higher step counts after 12 and 24 weeks compared to a control group; however, the difference was significant only at the midpoint of the intervention and was attributable to a decrease in steps for the control group. Text messaging did not increase step counts but may be a cost effective tool for maintenance of physical activity behavior. PMID:25110303

  13. Fluctuations in electrodermal activity reveal variations in single trial brain responses to painful laser stimuli--a fMRI/EEG study.

    PubMed

    Mobascher, A; Brinkmeyer, J; Warbrick, T; Musso, F; Wittsack, H J; Stoermer, R; Saleh, A; Schnitzler, A; Winterer, G

    2009-02-01

    Pain is a complex experience with sensory, emotional and cognitive aspects. It also includes a sympathetic response that can be captured by measuring the electrodermal activity (EDA). The present study was performed to investigate which brain areas are associated with sympathetic activation in experimental pain; an issue that has not been addressed with fMRI (functional magnetic resonance imaging) thus far. Twelve healthy subjects received painful laser stimulation to the left hand. The event-related fMRI BOLD (blood oxygen level dependent) response was measured together with simultaneous EEG (electroencephalography) and EDA recordings. Laser stimuli induced the expected EDA response, evoked EEG potentials and BOLD responses. Single trial EDA amplitudes were used to guide further analysis of fMRI and EEG data. We found significantly higher BOLD responses in trials with high EDA vs. low EDA trials, predominantly in the insula and somatosensory cortex (S1/S2). Likewise, in the EEG we found the N2 laser evoked potentials to have significantly higher amplitudes in trials with high vs. low EDA. Furthermore EDA-informed BOLD modeling explained additional signal variance in sensory areas and yielded higher group level activation. We conclude that the sympathetic response to pain is associated with activation in pain-processing brain regions, predominantly in sensory areas and that single trial (EDA)-information can add to BOLD modeling by taking some of the response variability across trials and subjects into account. Thus, EDA is a useful additional, objective index when pain is studied with fMRI/EEG which might be of particular relevance in the context of genetic- and pharmacoimaging. PMID:18848631

  14. Automated segmentation and registration technique for HMPAO-SPECT imaging of Alzheimer's patients

    NASA Astrophysics Data System (ADS)

    Radau, Perry E.; Slomka, Piotr J.; Julin, Per; Svensson, Leif; Wahlund, Lars-Olof

    2000-06-01

    We present an operator-independent software technique for segmentation, realignment and analysis of brain perfusion images, with both voxel-wise and regional quantitation methods. Inter-subject registration with normalized mutual information was tested with simulated defects. Brain perfusion images (HMPAO-SPECT) from 56 subjects (21 AD; 35 controls) were retrospectively analyzed. Templates were created from the 3-D registration of the controls. Automatic segmentation was developed to remove extraneous activity that disrupts registration. Two new registration methods, robust least squares (RLS) and normalized mutual information (NMI) were implemented and compared with sum of absolute differences (CD). The automatic segmentation method caused a registration displacement of 0.4 +/- 0.3 pixels compared with manual segmentation. NMI registration proved to be less adversely effected by simulated defects than RLS or CD. The error in quantitating the patient-template parietal ratio due to mis- registration was 2.0% and 0.5% for 70% and 85% hypoperfusion defects, respectively. The registration processing time was 1.6 min (233 MHz Pentium). The most accurate discriminant utilized a logistic equation parameterized by mean counts of the parietal and temporal regions of the map, (91 +/- 8% Se, 97 +/- 5% Sp). BRASS is a fast, objective software package for single-step analysis of brain SPECT, suitable to aid diagnosis of AD.

  15. [Progress of research in retinal image registration].

    PubMed

    Yu, Lun; Wei, Lifang; Pan, Lin

    2011-10-01

    The retinal image registration has important applications in the processes of auxiliary diagnosis and treatment for a variety of diseases. The retinal image registration can be used to measure the disease process and the therapeutic effect. A variety of retinal image registration techniques have been studied extensively in recent years. However, there are still many problems existing and there are numerous research possibilities. Based on extensive investigation of existing literatures, the present paper analyzes the feature of retinal image and current challenges of retinal image registration, and reviews the transformation models of the retinal image registration technology and the main research algorithms in current retinal image registration, and analyzes the advantages and disadvantages of various types of algorithms. Some research challenges and future developing trends are also discussed.

  16. Evaluating Similarity Measures for Brain Image Registration

    PubMed Central

    Razlighi, Q. R.; Kehtarnavaz, N.; Yousefi, S.

    2013-01-01

    Evaluation of similarity measures for image registration is a challenging problem due to its complex interaction with the underlying optimization, regularization, image type and modality. We propose a single performance metric, named robustness, as part of a new evaluation method which quantifies the effectiveness of similarity measures for brain image registration while eliminating the effects of the other parts of the registration process. We show empirically that similarity measures with higher robustness are more effective in registering degraded images and are also more successful in performing intermodal image registration. Further, we introduce a new similarity measure, called normalized spatial mutual information, for 3D brain image registration whose robustness is shown to be much higher than the existing ones. Consequently, it tolerates greater image degradation and provides more consistent outcomes for intermodal brain image registration. PMID:24039378

  17. Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: A preliminary randomized controlled trial

    PubMed Central

    Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6–8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions’ similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. PMID:24089423

  18. Using self-determination theory to promote physical activity and weight control: a randomized controlled trial in women.

    PubMed

    Silva, Marlene N; Vieira, Paulo N; Coutinho, Sílvia R; Minderico, Cláudia S; Matos, Margarida G; Sardinha, Luís B; Teixeira, Pedro J

    2010-04-01

    Behavior change interventions are effective to the extent that they affect appropriately-measured outcomes, especially in experimental controlled trials. The primary goal of this study was to analyze the impact of a 1-year weight management intervention based on self-determination theory (SDT) on theory-based psychosocial mediators, physical activity/exercise, and body weight and composition. Participants were 239 women (37.6 +/- 7.1 years; 31.5 +/- 4.1 kg/m(2)) who received either an intervention focused on promoting autonomous forms of exercise regulation and intrinsic motivation, or a general health education program (controls). At 12 months, the intervention group showed increased weight loss (-7.29%,) and higher levels of physical activity/exercise (+138 +/- 26 min/day of moderate plus vigorous exercise; +2,049 +/- 571 steps/day), compared to controls (P < 0.001). Main intervention targets such as more autonomous self-regulation (for treatment and for exercise) and a more autonomous perceived treatment climate revealed large effect sizes (between 0.80 and .96), favoring intervention (P < 0.001). Results suggest that interventions grounded in SDT can be successfully implemented in the context of weight management, enhancing the internalization of more autonomous forms of behavioral regulation, and facilitating exercise adherence, while producing clinically-significant weight reduction, when compared to a control condition. Findings are fully consistent with previous studies conducted within this theoretical framework in other areas of health behavior change.

  19. Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: a preliminary randomized controlled trial.

    PubMed

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-08-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6-8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions' similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout.

  20. Tracking real-time neural activation of conceptual knowledge using single-trial event-related potentials.

    PubMed

    Amsel, Ben D

    2011-04-01

    Empirically derived semantic feature norms categorized into different types of knowledge (e.g., visual, functional, auditory) can be summed to create number-of-feature counts per knowledge type. Initial evidence suggests several such knowledge types may be recruited during language comprehension. The present study provides a more detailed understanding of the timecourse and intensity of influence of several such knowledge types on real-time neural activity. A linear mixed-effects model was applied to single trial event-related potentials for 207 visually presented concrete words measured on total number of features (semantic richness), imageability, and number of visual motion, color, visual form, smell, taste, sound, and function features. Significant influences of multiple feature types occurred before 200ms, suggesting parallel neural computation of word form and conceptual knowledge during language comprehension. Function and visual motion features most prominently influenced neural activity, underscoring the importance of action-related knowledge in computing word meaning. The dynamic time courses and topographies of these effects are most consistent with a flexible conceptual system wherein temporally dynamic recruitment of representations in modal and supramodal cortex are a crucial element of the constellation of processes constituting word meaning computation in the brain.

  1. Effectiveness of a low-threshold physical activity intervention in residential aged care – results of a randomized controlled trial

    PubMed Central

    Cichocki, Martin; Quehenberger, Viktoria; Zeiler, Michael; Adamcik, Tanja; Manousek, Matthias; Stamm, Tanja; Krajic, Karl

    2015-01-01

    Purpose Research on effectiveness of low-threshold mobility interventions that are viable for users of residential aged care is scarce. Low-threshold is defined as keeping demands on organizations (staff skills, costs) and participants (health status, discipline) rather low. The study explored the effectiveness of a multi-faceted, low-threshold physical activity program in three residential aged-care facilities in Austria. Main goals were enhancement of mobility by conducting a multi-faceted training program to foster occupational performance and thus improve different aspects of health-related quality of life (QoL). Participants and methods The program consisted of a weekly session of 60 minutes over a period of 20 weeks. A standardized assessment of mobility status and health-related QoL was applied before and after the intervention. A total of 222 of 276 participants completed the randomized controlled trial study (intervention group n=104, control group n=118; average age 84 years, 88% female). Results Subjective health status (EuroQoL-5 dimensions: P=0.001, d=0.36) improved significantly in the intervention group, and there were also positive trends in occupational performance (Canadian Occupational Performance Measure). No clear effects were found concerning the functional and cognitive measures applied. Conclusion Thus, the low-threshold approach turned out to be effective primarily on subjective health-related QoL. This outcome could be a useful asset for organizations offering low-threshold physical activity interventions. PMID:26056438

  2. 77 FR 59611 - Notice of Receipt of Pesticide Products; Registration Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-28

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

  3. Increased platelet aggregation and in vivo platelet activation after granulocyte colony-stimulating factor administration. A randomised controlled trial.

    PubMed

    Spiel, Alexander O; Bartko, Johann; Schwameis, Michael; Firbas, Christa; Siller-Matula, Jolanta; Schuetz, Matthias; Weigl, Manuela; Jilma, Bernd

    2011-04-01

    Granulocyte colony-stimulating factor (G-CSF) stimulates the bone marrow to produce granulocytes and stem cells and is widely used to accelerate neutrophil recovery after chemotherapy. Interestingly, specific G-CSF receptors have been demonstrated not only on myeloid cells, but also on platelets. Data on the effects of G-CSF on platelet function are limited and partly conflicting. The objective of this study was to determine the effect of G-CSF on platelet aggregation and in vivo platelet activation. Seventy-eight, healthy volunteers were enrolled into this randomised, placebo-controlled trial. Subjects received 5 μg/kg methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF, filgrastim) or placebo subcutaneously for four days. We determined platelet aggregation with a whole blood impedance aggregometer with various, clinically relevant platelet agonists (adenosine diphosphate [ADP], collagen, arachidonic acid [AA], ristocetin and thrombin receptor activating peptide 6 [TRAP]). Filgrastim injection significantly enhanced ADP (+40%), collagen (+60%) and AA (+75%)-induced platelet aggregation (all p<0.01 as compared to placebo and p<0.001 as compared to baseline). In addition, G-CSF enhanced ristocetin-induced platelet aggregation (+18%) whereas TRAP-induced platelet aggregation decreased slightly (-14%) in response to filgrastim. While baseline aggregation with all agonists was only slightly but insignificantly higher in women than in men, this sex difference was enhanced by G-CSF treatment, and became most pronounced for ADP after five days (p<0.001). Enhanced platelet aggregation translated into a 75% increase in platelet activation as measured by circulating soluble P-selectin. G-CSF enhances platelet aggregation and activation in humans. This may put patients suffering from cardiovascular disease and cancer at risk for thrombotic events. PMID:21301783

  4. A virtual patient educational activity to improve interprofessional competencies: A randomized trial.

    PubMed

    Shoemaker, Michael J; de Voest, Margaret; Booth, Andrew; Meny, Lisa; Victor, Justin

    2015-01-01

    The purpose of the present study was to determine whether an interprofessional virtual patient educational activity improved interprofessional competencies in pharmacy, physician assistant, and physical therapy graduate students. Seventy-two fifth semester pharmacy (n = 33), fourth semester physician assistant (n = 27) and fourth semester physical therapy (n = 12) graduate students participated in the study. Participants were stratified by discipline and randomized into control (n = 38) and experimental groups (n = 34). At baseline and at study completion, all participants completed an original, investigator-developed survey that measured improvement in selected Interprofessional Education Collaborative (IPEC) competencies and the Readiness for Interprofessional Learning Scale (RIPLS). The experimental group had statistically significantly greater odds of improving on a variety of IPEC competencies and RIPLS items. The use of a single, interprofessional educational activity resulted in having a greater awareness of other professions' scopes of practice, what other professions have to offer a given patient and how different professions can collaborate in patient care. PMID:25412759

  5. Internet-Based Exposure and Behavioral Activation for Complicated Grief and Rumination: A Randomized Controlled Trial.

    PubMed

    Eisma, Maarten C; Boelen, Paul A; van den Bout, Jan; Stroebe, Wolfgang; Schut, Henk A W; Lancee, Jaap; Stroebe, Margaret S

    2015-11-01

    This study examined the effectiveness and feasibility of therapist-guided Internet-delivered exposure (EX) and behavioral activation (BA) for complicated grief and rumination. Forty-seven bereaved individuals with elevated levels of complicated grief and grief rumination were randomly assigned to three conditions: EX (N=18), BA (N=17), or a waiting-list (N=12). Treatment groups received 6 homework assignments over 6 to 8weeks. Intention-to-treat analyses showed that EX reduced complicated grief, posttraumatic stress, depression, grief rumination, and brooding levels relative to the control group at posttreatment (d=0.7-1.2). BA lowered complicated grief, posttraumatic stress, and grief rumination levels at posttreatment (d=0.8-0.9). At 3-month follow-up, effects of EX were maintained on complicated grief and grief rumination (d=0.6-1.2), and for BA on complicated grief, posttraumatic stress, and grief rumination (d=0.8-0.9). EX reduced depression more strongly than BA (d=0.6). Completers analyses corroborated results for EX, and partially those for BA, but no group differences were detected. BA suffered from high dropout (59%), relative to EX (33%) and the waiting-list (17%). Feasibility appeared higher for EX than BA. Results supported potential applicability of online exposure but not behavioral activation to decrease complicated grief and rumination. PMID:26520217

  6. A Systemic Review on Aloe arborescens Pharmacological Profile: Biological Activities and Pilot Clinical Trials.

    PubMed

    Singab, Abdel-Naser B; El-Hefnawy, Hala M; Esmat, Ahmed; Gad, Haidy A; Nazeam, Jilan A

    2015-12-01

    Since ancient times, plants and herbal preparations have been used as medicine. Research carried out in the last few decades has verified several such claims. Aloe arborescens Miller, belonging to the Aloe genus (Family Asphodelaceae), is one of the main varieties of Aloe used worldwide. The popularity of the plant in traditional medicine for several ailments (antitumor, immunomodulatory, antiinflammatory, antiulcer, antimicrobial and antifungal activity) focused the investigator's interest on this plant. Most importantly, the reported studies have shown the plant effectiveness on various cancer types such as liver, colon, duodenal, skin, pancreatic, intestinal, lung and kidney types. These multiple biological actions make Aloe an important resource for developing new natural therapies. However, the biological activities of isolated compounds such as glycoprotein, polysaccharides, enzyme and phenolics were insufficient. Considering all these, this contribution provides a systematic review outlining the evidence on the biological efficacy of the plant including the pharmacology and the related mechanisms of action, with specific attention to the various safety precautions, and preclinical and clinical studies, indicating the future research prospects of this plant. PMID:26768148

  7. [Evaluation of habitual physical activity of children during clinical and epidemiological trials].

    PubMed

    Guinhouya, Benjamin Comlavi; Apété, Géffroy K; Hubert, Hervé

    2009-01-01

    This synthesis presents the principles of action, advantages and disadvantages of five categories of methods (calorimetry, heart rate monitors, actimetry, observation, questionnaire) utilised to assess habitual physical activity (HPA) of children in clinical practice settings and/or at the time of epidemiological follow-up or management. The aggregation of a set of criteria related to the validity/reliability, ease of administration, ethics, cost and objectives should guide the choice of one method over another. The use of methods recognised as high-standard references (i.e. calorimetry, double-labelled water, direct observation) is limited in public health due to their cost. Heart rate monitors are associated with some discomfort for children, and furthermore, there are questionable due to distortions with regard to the telemetric signal. Actimetry, especially the use of accelerometers, seems to be a balanced approach. Although its use is well-suited to individual diagnosis and clinical research, its relative complexity limits its potential interest and use for epidemiology or for disseminating health messages. Thus, despite the difficulties associated with their use among children (bias related to misunderstanding, impressions and beliefs, socially acceptable response and cognitive/memory limitations), self-administered reporting methods can be useful for large-scale studies and may help in taking into account the perceptual dimension of physical activity and the child's health status. PMID:20218408

  8. Cluster Randomized Trial of a Church-Based Peer Counselor and Tailored Newsletter Intervention to Promote Colorectal Cancer Screening and Physical Activity among Older African Americans

    ERIC Educational Resources Information Center

    Leone, Lucia A.; Allicock, Marlyn; Pignone, Michael P.; Walsh, Joan F.; Johnson, La-Shell; Armstrong-Brown, Janelle; Carr, Carol C.; Langford, Aisha; Ni, Andy; Resnicow, Ken; Campbell, Marci K.

    2016-01-01

    Action Through Churches in Time to Save Lives (ACTS) of Wellness was a cluster randomized controlled trial developed to promote colorectal cancer screening and physical activity (PA) within urban African American churches. Churches were recruited from North Carolina (n = 12) and Michigan (n = 7) and were randomized to intervention (n = 10) or…

  9. The Lifestyle Interventions and Independence for Elders (LIFE) study, randomized trial of physical activity: Effect on the prevention of major mobility disability

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In older adults reduced mobility is common and is an independent risk factor for morbidity, hospitalization, disability, and mortality. Limited evidence suggests that physical activity may help prevent mobility disability; however, there are no definitive clinical trials examining if physical activi...

  10. Changes in cognitive function in a randomized trial of physical activity: results of the lifestyle interventions and independence for elders pilot study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Background. Cognitive impairment is an important contributor to disability. Limited clinical trial evidence exists regarding the impact of physical exercise on cognitive function (CF). We report results of a pilot study to provide estimates of the relative impact of physical activity (PA) on 1-year ...

  11. Cost-Effectiveness of a Long-Term Internet-Delivered Worksite Health Promotion Programme on Physical Activity and Nutrition: A Cluster Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

    2012-01-01

    This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a…

  12. Clinical Trials | Division of Cancer Prevention

    Cancer.gov

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  13. Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya

    PubMed Central

    2014-01-01

    Background Community engagement (CE) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes. Given the potential importance of CE, but also complexities and possibility of unexpected negative outcomes, there is need for more documentation of CE processes in practice. We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya. Methods Social scientists independent of the trial held in-depth individual interviews with trial researchers (n = 5), community leaders (n = 8) and parents (15 with enrolled children and 4 without); and group discussions with fieldworkers (n = 6) and facility staff (n = 2). We conducted a survey of participating households (n = 200) and observed over 150 CE activities. Results The overall CE plan was similar across the three study sites, although less community-based information in site C. Majority perceived CE activities to clear pre-existing concerns and misconceptions; increase visibility, awareness of and trust in trial staff. Challenges included: some community leaders attempting to exert pressure on people to enrol; local wording in information sheets and consent forms feeding into serious anxieties about the trial; and concerns about reduced CE over time. Negative effects of these challenges were mitigated through changes to on-going CE activities, and final information sharing and consent being conducted individually by trained clinical staff. One year after enrolment, 31% (n = 62) of participants’ parents reported malaria prevention as the main aim of the activities their children were involved in, and 93% wanted their children to remain involved. Conclusion The trial teams’ goals for CE were relatively clear from the outset. Other actors’ hopes and expectations (like higher allowances and future employment) were not openly discussed, but emerged

  14. Effect of Registration on Cyclical Kinematic Data

    PubMed Central

    Crane, Elizabeth A.; Cassidy, Ruth B.; Rothman, Edward D.; Gerstner, Geoffrey E.

    2010-01-01

    Given growing interest in Functional Data Analysis (FDA) as a useful method for analyzing human movement data, it is critical to understand the effects of standard FDA procedures, including registration, on biomechanical analyses. Registration is used to reduce phase variability between curves while preserving the individual curves shape and amplitude. The application of three methods available to assess registration could benefit those in the biomechanics community using FDA techniques: comparison of mean curves, comparison of average RMS values, and assessment of time-warping functions. Therefore, the present study has two purposes. First, the necessity of registration applied to cyclical data after time normalization is assessed. Second, we illustrate the three methods for evaluating registration effects. Masticatory jaw movements of 22 healthy adults (2 males, 21 females) were tracked while subjects chewed a gum-based pellet for 20 seconds. Motion data were captured at 60 Hz with two gen-locked video cameras. Individual chewing cycles were time normalized and then transformed into functional observations. Registration did not affect mean curves and warping functions were linear. Although registration decreased the RMS, indicating a decrease in inter-subject variability, the difference was not statistically significant. Together these results indicate that registration may not always be necessary for cyclical chewing data. An important contribution of this paper is the illustration of three methods for evaluating registration that are easy to apply and useful for judging whether the extra data manipulation is necessary. PMID:20537335

  15. Unbiased rigid registration using transfer functions

    NASA Astrophysics Data System (ADS)

    Hahn, Dieter A.; Hornegger, Joachim; Bautz, Werner; Kuwert, Torsten; Roemer, Wolfgang

    2005-04-01

    The evaluation of tumor growth as regression under therapy is an important clinical issue. Rigid registration of sequentially acquired 3D-images has proven its value for this purpose. Existing approaches to rigid image registration use the whole volume for the estimation of the rigid transform. Non-rigid soft tissue deformation, however, will imply a bias to the registration result, because local deformations cannot be modeled by rigid transforms. Anatomical substructures, like bones or teeth, are not affected by these deformations, but follow a rigid transform. This important observation is incorporated in the proposed registration algorithm. The selection of anatomical substructure is done by manual interaction of medical experts adjusting the transfer function of the volume rendering software. The parameters of the transfer function are used to identify the voxels that are considered for registration. A rigid transform is estimated by a quaternion gradient descent algorithm based on the intensity values of the specified tissue classes. Commonly used voxel intensity measures are adjusted to the modified registration algorithm. The contribution describes the mathematical framework of the proposed registration method and its implementation in a commercial software package. The experimental evaluation includes the discussion of different similarity measures, the comparison of the proposed method to established rigid registration techniques and the evaluation of the efficiency of the new method. We conclude with the discussion of potential medical applications of the proposed registration algorithm.

  16. Effect of registration on cyclical kinematic data.

    PubMed

    Crane, Elizabeth A; Cassidy, Ruth B; Rothman, Edward D; Gerstner, Geoffrey E

    2010-08-26

    Given growing interest in functional data analysis (FDA) as a useful method for analyzing human movement data, it is critical to understand the effects of standard FDA procedures, including registration, on biomechanical analyses. Registration is used to reduce phase variability between curves while preserving the individual curve's shape and amplitude. The application of three methods available to assess registration could benefit those in the biomechanics community using FDA techniques: comparison of mean curves, comparison of average RMS values, and assessment of time-warping functions. Therefore, the present study has two purposes. First, the necessity of registration applied to cyclical data after time normalization is assessed. Second, we illustrate the three methods for evaluating registration effects. Masticatory jaw movements of 22 healthy adults (2 males, 21 females) were tracked while subjects chewed a gum-based pellet for 20s. Motion data were captured at 60 Hz with two gen-locked video cameras. Individual chewing cycles were time normalized and then transformed into functional observations. Registration did not affect mean curves and warping functions were linear. Although registration decreased the RMS, indicating a decrease in inter-subject variability, the difference was not statistically significant. Together these results indicate that registration may not always be necessary for cyclical chewing data. An important contribution of this paper is the illustration of three methods for evaluating registration that are easy to apply and useful for judging whether the extra data manipulation is necessary.

  17. Error correction in image registration using POCS

    NASA Astrophysics Data System (ADS)

    Duraisamy, Prakash; Alam, Mohammad S.; Jackson, Stephen C.

    2011-04-01

    Image registration plays a vital role in many real time imaging applications. Registering the images in a precise manner is a challenging problem. In this paper, we focus on improving image registration error computation using the projection onto convex sets (POCS) techniques which improves the sub-pixel accuracy in the images leading to better estimates for the registration error. This can be used in turn to improve the registration itself. The results obtained from the proposed technique match well with the ground truth which validates the accuracy of this technique. Furthermore, the proposed technique shows better performance compared to existing methods.

  18. Trial Watch

    PubMed Central

    Vacchelli, Erika; Aranda, Fernando; Eggermont, Alexander; Galon, Jérôme; Sautès-Fridman, Catherine; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2014-01-01

    In 1997, for the first time in history, a monoclonal antibody (mAb), i.e., the chimeric anti-CD20 molecule rituximab, was approved by the US Food and Drug Administration for use in cancer patients. Since then, the panel of mAbs that are approved by international regulatory agencies for the treatment of hematopoietic and solid malignancies has not stopped to expand, nowadays encompassing a stunning amount of 15 distinct molecules. This therapeutic armamentarium includes mAbs that target tumor-associated antigens, as well as molecules that interfere with tumor-stroma interactions or exert direct immunostimulatory effects. These three classes of mAbs exert antineoplastic activity via distinct mechanisms, which may or may not involve immune effectors other than the mAbs themselves. In previous issues of OncoImmunology, we provided a brief scientific background to the use of mAbs, all types confounded, in cancer therapy, and discussed the results of recent clinical trials investigating the safety and efficacy of this approach. Here, we focus on mAbs that primarily target malignant cells or their interactions with stromal components, as opposed to mAbs that mediate antineoplastic effects by activating the immune system. In particular, we discuss relevant clinical findings that have been published during the last 13 months as well as clinical trials that have been launched in the same period to investigate the therapeutic profile of hitherto investigational tumor-targeting mAbs. PMID:24605265

  19. 37 CFR 2.173 - Amendment of registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... change in the mark: a new specimen showing the mark as used on or in connection with the goods or...) Registration must still contain registrable matter. The registration as amended must still contain registrable matter, and the mark as amended must be registrable as a whole. (d) Amendment may not materially...

  20. 27 CFR 31.111 - Date registration form is due.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Date registration form is....111 Date registration form is due. (a) General. Dealers must register by filing the registration form... form was filed, no additional registration is required. If the registration form is received in...

  1. 14 CFR 47.61 - Dealer's Aircraft Registration Certificates.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Dealer's Aircraft Registration Certificates... TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Dealers' Aircraft Registration Certificate § 47.61 Dealer's Aircraft Registration Certificates. (a) The FAA issues a Dealer's Aircraft Registration Certificate,...

  2. 14 CFR 47.61 - Dealers' Aircraft Registration Certificates.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Dealers' Aircraft Registration Certificates... TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Dealers' Aircraft Registration Certificate § 47.61 Dealers' Aircraft Registration Certificates. (a) The FAA issues a Dealers' Aircraft Registration Certificate,...

  3. 14 CFR 47.61 - Dealer's Aircraft Registration Certificates.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Dealer's Aircraft Registration Certificates... TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Dealers' Aircraft Registration Certificate § 47.61 Dealer's Aircraft Registration Certificates. (a) The FAA issues a Dealer's Aircraft Registration Certificate,...

  4. Fe en Accion/Faith in Action: Design and implementation of a church-based randomized trial to promote physical activity and cancer screening among churchgoing Latinas

    PubMed Central

    Arredondo, Elva M.; Haughton, Jessica; Ayala, Guadalupe X.; Slymen, Donald J.; Sallis, James F.; Burke, Kari; Holub, Christina; Chanson, Dayana; Perez, Lilian G.; Valdivia, Rodrigo; Ryan, Sherry; Elder, John

    2015-01-01

    Objectives To describe both conditions of a two-group randomized trial, one that promotes physical activity and one that promotes cancer screening, among churchgoing Latinas. The trial involves promotoras (community health workers) targeting multiple levels of the Ecological Model. This trial builds on formative and pilot research findings. Design Sixteen churches were randomly assigned to either the physical activity intervention or cancer screening comparison condition (approximately 27 women per church). In both conditions, promotoras from each church intervened at the individual- (e.g., beliefs), interpersonal- (e.g., social support), and environmental- (e.g., park features and access to health care) levels to affect change on target behaviors. Measurements The study’s primary outcome is min/wk of moderate-to-vigorous physical activity (MVPA) at baseline and 12 and 24 months following implementation of intervention activities. We enrolled 436 Latinas (aged 18–65 years) who engaged in less than 250 min/wk of MVPA at baseline as assessed by accelerometer, attended church at least four times per month, lived near their church, and did not have a health condition that could prevent them from participating in physical activity. Participants were asked to complete measures assessing physical activity and cancer screening as well as their correlates at 12- and 24-months. Summary Findings from the current study will address gaps in research by showing the long term effectiveness of multi-level faith-based interventions promoting physical activity and cancer screening among Latino communities. PMID:26358535

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

    Jepson, Ruth

    2016-01-01

    Introduction. Physical activity is important for health and well-being; however, rates of postnatal physical activity can be low. This paper reports the secondary outcomes of a trial aimed at increasing physical activity among postnatal women. Methods. More Active MuMs in Stirling (MAMMiS) was a randomised controlled trial testing the effect of physical activity consultation and pram walking group intervention among inactive postnatal women. Data were collected on postnatal weight, body composition, general well-being, and fatigue. Participants were also interviewed regarding motivations and perceived benefits of participating in the trial. Results. There was no significant effect of the intervention on any weight/body composition outcome or on general well-being at three or six months of follow-up. There was a significant but inconsistent difference in fatigue between groups. Qualitative data highlighted a number of perceived benefits to weight, body composition, and particularly well-being (including improved fatigue) which were not borne out by objective data. Discussion. The MAMMiS study found no impact of the physical activity intervention on body composition and psychological well-being and indicates that further research is required to identify successful approaches to increase physical activity and improve health and well-being among postnatal women. PMID:27610245

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

    PubMed

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

    2016-01-01

    Introduction. Physical activity is important for health and well-being; however, rates of postnatal physical activity can be low. This paper reports the secondary outcomes of a trial aimed at increasing physical activity among postnatal women. Methods. More Active MuMs in Stirling (MAMMiS) was a randomised controlled trial testing the effect of physical activity consultation and pram walking group intervention among inactive postnatal women. Data were collected on postnatal weight, body composition, general well-being, and fatigue. Participants were also interviewed regarding motivations and perceived benefits of participating in the trial. Results. There was no significant effect of the intervention on any weight/body composition outcome or on general well-being at three or six months of follow-up. There was a significant but inconsistent difference in fatigue between groups. Qualitative data highlighted a number of perceived benefits to weight, body composition, and particularly well-being (including improved fatigue) which were not borne out by objective data. Discussion. The MAMMiS study found no impact of the physical activity intervention on body composition and psychological well-being and indicates that further research is required to identify successful approaches to increase physical activity and improve health and well-being among postnatal women. PMID:27610245

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

    PubMed Central

    Jepson, Ruth

    2016-01-01

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

  9. 21 CFR 1301.52 - Termination of registration; transfer of registration; distribution upon discontinuance of business.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Termination of registration; transfer of registration; distribution upon discontinuance of business. 1301.52 Section 1301.52 Food and Drugs DRUG... person seeking authority to transfer a registration shall submit a written request, providing...

  10. 16 CFR 1130.8 - Requirements for Web site registration or alternative e-mail registration.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... alternative e-mail registration. 1130.8 Section 1130.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PRODUCTS § 1130.8 Requirements for Web site registration or alternative e-mail registration. (a) Link to... a link to the manufacturer's home page, a field to confirm submission, and a prompt to indicate...

  11. 28 CFR 12.3 - Prior registration with the Foreign Agents Registration Unit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Prior registration with the Foreign Agents Registration Unit. 12.3 Section 12.3 Judicial Administration DEPARTMENT OF JUSTICE REGISTRATION OF CERTAIN PERSONS HAVING KNOWLEDGE OF FOREIGN ESPIONAGE, COUNTERESPIONAGE, OR SABOTAGE MATTERS UNDER THE...

  12. 75 FR 37790 - Lauryl Sulfate Salts; Antimicrobial Registration Review Final Work Plan and Proposed Registration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-30

    ... AGENCY Lauryl Sulfate Salts; Antimicrobial Registration Review Final Work Plan and Proposed Registration... decision for the pesticide lauryl sulfate salts, case number 4061 and opens a public comment period on the... availability of EPA's proposed registration review decision for the pesticide lauryl sulfate salts, case...

  13. 21 CFR 1301.52 - Termination of registration; transfer of registration; distribution upon discontinuance of business.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Termination of registration; transfer of registration; distribution upon discontinuance of business. 1301.52 Section 1301.52 Food and Drugs DRUG... OF CONTROLLED SUBSTANCES Modification, Transfer and Termination of Registration § 1301.52...

  14. 21 CFR 1301.52 - Termination of registration; transfer of registration; distribution upon discontinuance of business.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Termination of registration; transfer of registration; distribution upon discontinuance of business. 1301.52 Section 1301.52 Food and Drugs DRUG... OF CONTROLLED SUBSTANCES Modification, Transfer and Termination of Registration § 1301.52...

  15. 21 CFR 1301.52 - Termination of registration; transfer of registration; distribution upon discontinuance of business.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Termination of registration; transfer of registration; distribution upon discontinuance of business. 1301.52 Section 1301.52 Food and Drugs DRUG... OF CONTROLLED SUBSTANCES Modification, Transfer and Termination of Registration § 1301.52...

  16. 21 CFR 1301.52 - Termination of registration; transfer of registration; distribution upon discontinuance of business.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Termination of registration; transfer of registration; distribution upon discontinuance of business. 1301.52 Section 1301.52 Food and Drugs DRUG... OF CONTROLLED SUBSTANCES Modification, Transfer and Termination of Registration § 1301.52...

  17. PAHA study: Psychological Active and Healthy Aging: psychological wellbeing, proactive attitude and happiness effects of whole-body vibration versus Multicomponent Training in aged women: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Evidence demonstrates that physical exercise and psychological wellbeing are closely interlinked, particularly in older-aged women. However, research investigating how different forms of exercise influence mental health in older-aged women is underdeveloped. Methods/Design A randomized controlled trial (N = 300) will assess the relative effectiveness of two different exercise programs (whole-body vibration and Multicomponent Training) for improving psychological wellbeing in older-aged women. The following outcomes will be assessed at three time points (that is, pre, post, and follow-up): psychological wellbeing, proactive attitude, quality of life, and happiness. Discussion Results will have important implications for preventing psychological and physiological disease in older-aged women and for managing health-related costs for this population group. Trial registration Number NCT01966562 on Clinical Gov database the 8 October 2013 PMID:24886107

  18. Protocol for the saMS trial (supportive adjustment for multiple sclerosis): a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis

    PubMed Central

    2009-01-01

    Background Multiple Sclerosis (MS) is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS. Methods/Design This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks) will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks), mid-therapy (week 5 of therapy), post-therapy (15 weeks) and at six months (26 weeks) and twelve months (52 weeks) follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. Discussion This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the efficacy, cost

  19. REGISTRATION OF ORTHODONTIC DIGITAL MODELS

    PubMed Central

    Grauer, Dan; Cevidanes, Lucia H.; Tyndall, Donald; Styner, Martin A.; Flood, Patrick M.; Proffit, William R.

    2011-01-01

    Current methods to assess outcomes and change in orthodontics are comparison of photographs, cephalometric measurements and superimpositions, and comparisons/measurements on dental casts. Digital models are a relatively new records modality in orthodontics. They offer numerous advantages in terms of storage space, spatial registration and superimposition. The purpose of this chapter is to determine the reproducibility of: 1) establishing occlusion of independently scanned digital models; and 2) registering digital models obtained after treatment on their homologous digital model setups produced before treatment. Reliability of both procedures was assessed with two random samples of five patient’s models. In both experiments, three replicate positionings of the models per patient were created and variability in position was evaluated by the maximum surface difference between replicates, and the standard deviation of the surface distances between replicates respectively. Based on the data obtained, we concluded that it is reliable to register independently scanned models to a scanned surface of the models in occlusion. Surface-to-surface registration of final orthodontic digital models to planned setup models also is reproducible. PMID:26549917

  20. Interdisciplinary therapy changes superoxide dismutase activity and adiponectin in obese adolescents: a randomised controlled trial.

    PubMed

    Nunes, João Elias Dias; Cunha, Heitor Santos; Freitas, Zulmária Rezende; Nogueira, Ana Maria Caixeta; Dâmaso, Ana Raimunda; Espindola, Foued Salmen; Cheik, Nadia Carla

    2016-01-01

    The objective of this study is to evaluate the effect of interdisciplinary therapy in the parameters of the oxidative stress and the anti-inflammatory responses of obese adolescents. We selected 57 participants, who were randomly divided into 2 groups: interdisciplinary therapy group and a control group. After 6 months of intervention, 17 participants of the interdisciplinary therapy group and 8 of the control group returned for re-evaluation. The interdisciplinary therapy group participated in a treatment with 4 weekly sessions of exercise, a weekly group therapy session and a weekly nutritional education session. Blood parameters of oxidative stress and anti-inflammatory response were evaluated. The results demonstrated that there were significant increases in the interdisciplinary therapy group for superoxide dismutase activity (6.56 ± 3.22 to 11.40 ± 7.49) and ferric-reducing antioxidant potential concentration (532.91 ± 106.48 to 573.25 ± 112.57), although adiponectin levels did not reduce (40.9 ± 29.34 to 49.05 ± 41.22). A significant decrease in nitrite levels was also found (14.23 ± 8.48 to 11.45 ± 6.05). In the control group, significant reduction was found in adiponectin (31.56 ± 18.88 to 18.01 ± 11.66). This study suggests that interdisciplinary therapy for 6 months was effective in improving the anti-inflammatory responses and the antioxidant defences in obese adolescents. PMID:26367325